U.S. patent application number 12/780638 was filed with the patent office on 2010-09-02 for systems and methods of de-endothelialization.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to Elaine Lee, Stephen C. Porter, Paul S. Seifert, Michael P. Wallace.
Application Number | 20100222803 12/780638 |
Document ID | / |
Family ID | 32771019 |
Filed Date | 2010-09-02 |
United States Patent
Application |
20100222803 |
Kind Code |
A1 |
Seifert; Paul S. ; et
al. |
September 2, 2010 |
SYSTEMS AND METHODS OF DE-ENDOTHELIALIZATION
Abstract
Apparatus and methods for treating a wall of an aneurysm formed
in a vessel includes introducing a tubular member into the body
lumen until a distal end of the tubular member is located within
the aneurysm. A fluid is delivered via a lumen of the tubular
member into the aneurysm to at least partially de-endothelialize
the wall of the aneurysm, thereby causing an endothelium of the
wall to generate fibrous tissue to strengthen the wall of the
aneurysm.
Inventors: |
Seifert; Paul S.; (Oregon
House, CA) ; Lee; Elaine; (Sunnyvale, CA) ;
Wallace; Michael P.; (Pleasanton, CA) ; Porter;
Stephen C.; (Oakland, CA) |
Correspondence
Address: |
VISTA IP LAW GROUP LLP
12930 Saratoga Avenue, Suite D-2
Saratoga
CA
95070
US
|
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
MAPLE GROVE
MN
|
Family ID: |
32771019 |
Appl. No.: |
12/780638 |
Filed: |
May 14, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10357572 |
Feb 3, 2003 |
7744583 |
|
|
12780638 |
|
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|
Current U.S.
Class: |
606/194 |
Current CPC
Class: |
A61B 17/00491 20130101;
A61B 2017/22069 20130101; A61B 17/12113 20130101; A61B 2017/1205
20130101; A61B 17/12022 20130101; A61B 17/12045 20130101; A61B
17/1215 20130101; A61B 2017/22068 20130101; A61B 17/12159 20130101;
A61F 2/82 20130101; A61B 2017/12063 20130101; A61B 17/12186
20130101; A61B 17/12136 20130101; A61B 17/1219 20130101; A61B
17/12118 20130101; A61B 17/12145 20130101; A61M 29/02 20130101 |
Class at
Publication: |
606/194 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. An apparatus for disrupting an endothelium of an aneurysm, an
arterio-venous malformation, or a fistula, the apparatus
comprising: an outer member having a proximal end and a distal end,
the distal end having a size and shape for insertion into a body
lumen; an inner member deployable from within the outer member and
comprising a proximal end, a distal end, and a first lumen
extending between the proximal end and an outlet port on the distal
end; and a source of de-endothelialization fluid coupled to the
proximal end of the inner member and communicating with the first
lumen.
2. The apparatus of claim 1, wherein the de-endothelialization
fluid is a cytotoxic agent comprising a hypotonic fluid.
3. The apparatus of claim 1, wherein the distal end of at least one
inner and outer members includes an aspiration port and wherein at
least one of the inner and outer members comprises a second lumen
communicating with the aspiration port and a source of vacuum for
aspirating fluid from the treatment site.
4. The apparatus of claim 3, further comprising a sealing member
carried by one of the inner and outer members proximal to the
outlet port, the sealing member having a size and shape for
substantially sealing the body lumen, wherein the aspiration port
is disposed distal to the sealing member.
5. The apparatus of claim 1, further comprising a coil extending
from the distal end of the inner member, the coil configured for
directing fluid delivered from the outlet port in a desired pattern
within the treatment site.
6. The apparatus of claim 1, further comprising a balloon carried
on the distal end of the inner member, the balloon having the
outlet port thereon.
7. The apparatus of claim 6, wherein the outlet port comprises one
or more openings extending through a wall of the balloon and
communicating with an interior of the balloon, the interior of the
balloon communicating with the first lumen, the one or more
openings of the balloon sized such that when the balloon is
inflated by the de-endothelialization fluid, the one or more
openings expand sufficiently to allow the de-endothelialization
fluid to exit from the interior of the balloon through the one or
more openings.
8. The apparatus of claim 6, wherein the balloon comprises a
delivery lumen formed within a wall of the balloon communicating
with the outlet port and the first lumen.
9. An apparatus for disrupting an endothelium of a body lumen,
comprising: an elongate tubular member comprising a proximal end
and a distal end having a size and shape for insertion into a body
lumen, the tubular member comprising an infusion lumen and an
aspiration lumen extending between the proximal and distal ends; a
first fluid moving element communicating with the infusion lumen of
the tubular member; a second fluid moving element communicating
with the aspiration lumen of the tubular member; an actuator
coupled to the first and second fluid moving elements, the actuator
configured for simultaneously delivering fluid into the infusion
lumen and withdrawing fluid from the aspiration lumen; and a source
of de-endothelialization fluid communicating with the first
lumen.
10. The apparatus of claim 9, wherein the de-endothelialization
fluid is a cytotoxic agent comprising a hypotonic fluid.
11. The apparatus of claim 9, wherein the tubular member comprises
a first tubular member having a first lumen therein and a second
tubular member within the lumen of the first tubular member, and
wherein one of the infusion and aspiration lumens is defined
between the first and second tubular members, and the other of the
infusion and aspiration lumens is a lumen within the second tubular
member.
12. The apparatus of claim 9, further comprising an occlusion
member associated with the tubular member for substantially sealing
the body lumen.
13. The apparatus of claim 12, wherein the occlusion member
comprises an expandable member carried on the distal end of the
tubular member.
14. The apparatus of claim 12, wherein the occlusion member
comprises an expandable member carried on a distal end of an
elongate member.
15. The apparatus of claim 14, wherein the expandable member
comprises a compliant balloon, the balloon comprising a side port,
wherein one of the infusion and aspiration lumens communicates with
the side port.
16. The apparatus of claim 9, wherein the actuator comprises a
motor.
17. An apparatus for disrupting an endothelium of a body lumen,
comprising: a tubular member comprising a proximal end, a distal
end having a size and shape for insertion into a body lumen, and
first and second lumens extending between the first and second
lumens; a source of de-endothelialization fluid coupled to the
proximal end of the tubular member and communicating with the first
lumen for delivering the de-endothelialization fluid to tissue
adjacent the distal end to at least partially de-endothelialize the
tissue; and a source of vacuum coupled to the proximal end of the
tubular member and communicating with the second lumen for
aspirating excess de-endothelialization fluid from a region
adjacent the distal end of the tubular member.
18. The apparatus of claim 17, wherein the de-endothelialization
fluid is a cytotoxic agent comprising a hypotonic fluid.
Description
RELATED APPLICATION DATA
[0001] The present application is a continuation of pending U.S.
patent application Ser. No. 10/357,572, filed Feb. 3, 2003, the
priority of which is claimed under 35 U.S.C. .sctn.120, and the
contents of which is incorporated herein by reference in its
entirety, as though set forth in full.
FIELD OF THE INVENTION
[0002] The field of the invention pertains to embolizing blood
vessels or aneurysms, and more particularly, to systems and methods
for reducing blood vessel or aneurysm recanalization.
BACKGROUND
[0003] In many clinical situations, blood vessels are occluded for
a variety of purposes, such as to control bleeding, to prevent
blood supply to tumors, to stop blood flow to arterio-venous
malformations or fistulas, and to block blood flow within an
aneurysm.
[0004] Embolization of blood vessels is particularly useful in
treating aneurysms. Aneurysms are abnormal blood-filled dilations
of a blood vessel wall that may rupture causing significant
bleeding. For the cases of intracranial aneurysms, the significant
bleeding may lead to damage to surrounding brain tissue or death.
Intracranial aneurysms may be difficult to treat when they are
formed in remote cerebral blood vessels, which are very difficult
to access. If left untreated, hemodynamic forces of normal
pulsatile blood flow can rupture fragile tissue in the area of the
aneurysm causing a stroke.
[0005] Vaso-occlusive devices have been used to treat aneurysms.
Vaso-occlusive devices are surgical implants placed within blood
vessels or vascular cavities, typically using a catheter, to form a
thrombus and occlude the site. For instance, a stroke or other such
vascular accident may be treated by placing a vaso-occlusive device
proximal of the site to block the flow of blood to the site and
alleviate the leakage. An aneurysm may similarly be treated by
introducing a vaso-occlusive device through the neck of the
aneurysm. The thrombogenic properties of the vaso-occlusive device
cause a mass to form in the aneurysm and alleviate the potential
for growth of the aneurysm and its subsequent rupture. Other
diseases, such as tumors, may often be treated by occluding the
blood flow to the tumor.
[0006] There are a variety of vaso-occlusive devices suitable for
forming thrombi. One such device is found in U.S. Pat. No.
4,994,069, to Ritchart et al., the entirety of which is expressly
incorporated by reference herein. That patent describes a
vaso-occlusive coil that assumes a linear helical configuration
when stretched and a folded convoluted configuration when relaxed.
The stretched configuration is used to deliver the coil to the
desired site and the convoluted configuration occurs when the coil
is ejected from the catheter and the coil relaxes. Ritchart et al.
describes a variety of shapes, including "flower" shapes and double
vortices. A random shape is described as well.
[0007] U.S. Pat. No. 6,280,457B1 to Wallace et al., describes an
occlusive device comprising an inner core wire covered with a
polymer. The polymeric material includes protein based polymers,
absorbable polymers, non-protein based polymers, and combinations
thereof. The polymer may contribute to forming emboli for occluding
a body cavity.
[0008] Vaso-occlusive coils having complex, three-dimensional
structures in a relaxed configuration are described in U.S. Pat.
No. 6,322,576B1 to Wallace et al. The coils may be deployed in the
approximate shape of a sphere, an ovoid, a clover, a box-like
structure or other distorted spherical shape. The patent also
describes methods of winding the anatomically shaped vaso-occlusive
device into appropriately shaped forms and annealing them to form
various devices.
[0009] Vaso-occlusive coils having little or no inherent secondary
shape have also been described. For instance, co-owned U.S. Pat.
Nos. 5,690,666 and 5,826,587 by Berenstein et al., describe coils
having little or no shape after introduction into the vascular
space.
[0010] Vaso-occlusive devices work initially by slowing blood flow
inside the aneurysm. As a result of the slowed blood flow, the
blood inside the aneurysm clots. The combination of the
vaso-occlusive devices and the clot protects the aneurysm from
hemodynamic forces (i.e., forces on the aneurysm wall due to blood
flow) that may cause recanalization and recurrence of the aneurysm.
However, recanalization and recurrence of the aneurysm may still
occur for various reasons. For example, the vaso-occlusive device
may rearrange itself due to the hemodynamic forces. Typically, the
vaso-occlusive device(s) near the neck of the aneurysm is most
affected by the effects of blood flow. Also, the clot formed may
break down due to the hemodynamic forces and/or natural chemical
processes. This is more likely to occur if the aneurysm is loosely
packed with vaso-occlusive devices.
[0011] Accordingly, devices and methods for reducing recanalization
or recurrence of an aneurysm would be useful.
SUMMARY OF THE INVENTION
[0012] The present invention is directed to apparatus and methods
for treating aneurysms or other body cavities. More particularly,
the present invention is directed to apparatus and methods for
disrupting the endothelium of the wall of an aneurysm to reduce the
risk of the wall expanding, thinning, and/or or rupturing, or to
reduce the risk of recanalization of a body cavity, such as an
arterio-venous malformation, fistula, or other blood vessel.
[0013] In accordance with one aspect of the present invention, an
apparatus for disrupting an endothelium of an aneurysm or other
body lumen wall is provided. Generally, the apparatus includes an
elongate member including a proximal end and a distal end
configured for insertion into a body lumen of a patient. The distal
end of the elongate member may have a primary shape, e.g., a
substantially linear relaxed shape, a curvilinear relaxed shape,
and/or a helical coil shape. Optionally, the elongate member may
have a secondary shape, e.g., a three-dimensional shape towards
which the elongate member may be biased in a relaxed state free
from external forces. The elongate member may be formed from an
elastic or superelastic material and/or a bioabsorbable
material.
[0014] Any of the apparatus described herein may include a delivery
device, e.g., a sheath, catheter or other tubular member, for
delivering the elongate member. For example, the distal end of the
elongate member may be disposed within a lumen of the tubular
member as a distal end of the tubular member is advanced to a
treatment site, e.g., to prevent the distal end from contacting
tissue prematurely, i.e., until deployed.
[0015] Optionally, the distal end of the elongate member may be
deployable such that the distal end may remain within the aneurysm
or other body cavity upon completing the procedure. The distal end
of the elongate member may be deployable using a mechanical joint,
an electrolytic joint, and/or a dissolvable adhesive. In addition
or alternatively, the distal end of the elongate member may be
steerable, e.g., to guide the distal end around bends, into a body
cavity, such as an aneurysm sac, and/or otherwise manipulating the
distal end during a procedure.
[0016] In one embodiment, one or more abrasive elements are carried
on the distal end of the elongate member for disrupting the
endothelium of the aneurysm or other body cavity. The abrasive
element(s) may include hooks, needles, fins, saw tooth elements,
and/or sharp particles. The abrasive element(s) that may be
disposed on an entire exposed surface of the distal end of the
elongate member or may be selectively disposed in a pattern on only
a portion of the distal end. Preferably, the abrasive element(s)
has(have) a size and stiffness for disrupting the endothelium of a
vessel wall, e.g., a wall of an aneurysm, without substantial risk
of penetrating completely through the wall.
[0017] Optionally, an expandable member may be carried by the
distal end of the elongate member, the abrasive elements being
carried on the expandable member. For example, the expandable
member may be an expandable basket including one or more splines,
each carrying one or more abrasive elements. Alternatively, the
expandable member may be an elastic or inelastic balloon that may
be expanded upon introducing fluid into an interior of the balloon.
If the elongate member includes an expandable member, the
expandable member may be collapsed when disposed within a delivery
device, e.g., a sheath or other tubular member. The expandable
member may be biased to expand towards an expanded configuration
when deployed from the delivery device or may be controllably
expanded, e.g., mechanically or using a fluid. In addition, the
balloon may be porous and/or may include one or more openings or
lumens for delivering a fluid, e.g., a de-endothelialization fluid
beyond an outer surface of the balloon, as explained further
below.
[0018] An apparatus, such as those described above, may be used for
de-endothelializing an aneurysm. Initially, an apparatus may be
provided that includes an elongate member carrying one or more
abrasive elements on its distal end. The distal end may be
introduced into a body lumen, e.g., a patient's vasculature, and
advanced until the distal end reaches a target site intended for
treatment, e.g., an aneurysm within a cerebral or other artery. The
distal end may be provided within a catheter or other delivery
device to protect the vasculature from being damaged by the
abrasive elements and/or to protect the distal end of the elongate
member.
[0019] For example, a delivery catheter may be positioned adjacent
an aneurysm, and the distal end of the elongate member may be
advanced from a lumen of the catheter into the aneurysm. The distal
end of the elongate member may be manipulated, e.g., advanced,
retracted, steered, and/or rotated to engage the abrasive elements
with the wall of the aneurysm to disrupt the endothelium of the
wall. If an expandable member is carried on the distal end, the
expandable member may be expanded to enhance engaging the
endothelium with the abrasive elements. Consequently, the patient's
body may react to the disruption by generating fibrous tissue,
e.g., scar tissue, that may thicken or otherwise strengthen the
wall of the aneurysm, thereby substantially reducing the risk of
the wall thinning further and/or the aneurysm growing or
rupturing.
[0020] The elongate member may then be retracted into the catheter
and both removed from the patient. Alternatively, the distal end of
the elongate member may be released from the elongate member to at
least partially fill the aneurysm.
[0021] In accordance with another aspect of the present invention,
another apparatus for disrupting an endothelium of an aneurysm or
other body cavity wall is provided that uses thermal energy to
disrupt the endothelium. Similar to the previous embodiments, the
apparatus may include an elongate member having a distal end, which
may be steerable and/or deployable, as described above. A thermal
element may be carried by the distal end of the elongate member
that is configured for being heated or cooled to a
de-endothelializing temperature. Similar to the previous
embodiment, the distal end may include an expandable member, e.g.,
an expandable basket or balloon, that may carry the heating or
cooling element.
[0022] In one form, the thermal element may be an electrically
resistive heating element that may be coupled to a source of
electrical energy. Upon delivering electrical energy to the distal
end, the resistive heating element may become heated sufficiently
to disrupt the endothelium that it contacts directly or that is
heated by conduction and/or convection. Alternatively, the thermal
element may be an energy storage element that may be heated or
cooled before being inserted through a thermally insulated delivery
device, e.g., a sheath, that has been placed adjacent the
aneurysm.
[0023] In a further alternative, the thermal element may be an
expandable balloon or other hollow element. The hollow element may
be filled with a heated or cooled fluid to heat or cool the hollow
element to a desired temperature for de-endothelializing the wall
of an aneurysm that it contacts directly or to which it is coupled
by conduction or convection. Optionally, the hollow element may
include one or more openings such that the heated or cooled fluid
may be delivered from the hollow element into the aneurysm or body
cavity to disrupt the endothelium of the wall. In this embodiment,
the elongate member and/or the delivery device may include a
sealing member that may be used to at least partially seal the
aneurysm or a body lumen communicating with the aneurysm.
[0024] These embodiments may be used to disrupt the endothelium of
an aneurysm or other body cavity wall using thermal energy. The
distal end of the elongate member may be advanced from a delivery
device, such as a sheath or catheter, into the aneurysm. For
example, the delivery device may be advanced through the patient's
vasculature with the elongate member therein. Once the delivery
device is adjacent to the aneurysm, the distal end of the elongate
member may be advanced from the delivery device to place the
thermal element within the aneurysm.
[0025] If the thermal element includes an electrically resistive
heating element, electrical energy may be delivered to the heating
element, thereby heating the interior of the aneurysm and/or
heating the wall contacted by the heating element until the
endothelium is disrupted. Alternatively, if the thermal element
includes an expandable member, the expandable member may be
expanded within the aneurysm to at least partially fill the
aneurysm cavity.
[0026] In addition or alternatively, if the thermal element is
porous or includes outlet ports coupled to a source of heated or
cooled fluid via a lumen, the fluid may be delivered into the
aneurysm to disrupt the endothelium. Optionally, a sealing member
may be located proximal to the thermal element that may be expanded
or otherwise engaged with the neck of the aneurysm to substantially
seal the aneurysm. This may prevent fluid delivered into the
aneurysm from escaping into adjacent body lumen(s). Preferably, the
fluid is heated to a temperature above fifty degrees Celsius
(50.degree. C.) or cooled to a temperature below zero degrees
Celsius (0.degree. C.).
[0027] In accordance with yet another aspect of the present
invention, a method is provided for treating a wall of an aneurysm,
arterio-venous malformation, fistula, or other a body lumen. A
tubular member may be introduced into the vasculature until a
distal end of the tubular member is located within the aneurysm or
blood vessel. A fluid may be delivered via a lumen of the tubular
member into the aneurysm or blood vessel to at least partially
de-endothelialize the wall of the aneurysm or blood vessel. This
may cause an endothelium of the wall to generate fibrous tissue to
strengthen the wall of the aneurysm or to strengthen and/or occlude
the blood vessel.
[0028] In one embodiment, a sealing member may be carried by one of
the inner and outer members, and the sealing member may be engaged
with a neck of the aneurysm to substantially sealing the aneurysm
before the fluid is delivered into the aneurysm. In an exemplary
embodiment, the sealing member may include an annular shaped member
including an outer wall and a passage extending therethrough, and
wherein the annular shaped member positioned such that the outer
wall is disposed adjacent the neck of the aneurysm to substantially
seal the aneurysm and the passage is disposed coaxially within the
body lumen to allow continued fluid flow along the body lumen.
[0029] In addition or alternatively, the tubular member may include
a balloon carried on the distal end thereof, and wherein the fluid
is delivered via the balloon. For example, the balloon may include
one or more openings extending through a wall of the balloon and
communicating with an interior of the balloon, the fluid being
delivered into the aneurysm through the one or more openings. In
one embodiment, the fluid may be introduced into the interior of
the balloon, thereby expanding the balloon until the one or more
openings expand sufficiently to allow the fluid to exit from the
interior of the balloon through the one or more openings.
Alternatively, the balloon may include a delivery lumen formed
within a wall of the balloon and the fluid may be delivered into
the aneurysm through the delivery lumen. In another alternative,
the balloon may carry one or more abrasive elements configured for
disrupting the endothelium of the wall of the aneurysm, as
described above.
[0030] In accordance with yet another aspect of the present
invention, a method is provided for treating a wall of an aneurysm,
blood vessel, or other body lumen. A tubular member may be
introduced into the body lumen until a distal end of the tubular
member is located adjacent the aneurysm, the distal end carrying an
annular shaped member. The annular shaped member may be expanded
until an outer wall of the annular shaped member engages a neck of
the aneurysm to substantially seal the aneurysm, the annular shaped
member including a passage extending therethrough to allow
continued fluid flow along the body lumen. A fluid may be delivered
into the aneurysm to at least partially de-endothelialize the wall
of the aneurysm, thereby causing an endothelium of the wall to
generate fibrous tissue to strengthen the wall of the aneurysm.
[0031] In accordance with still another aspect of the present
invention, an apparatus is provided for disrupting an endothelium
of an aneurysm or other body lumen that includes an outer member
including a proximal end and a distal end having a size and shape
for insertion into a body lumen communicating with an aneurysm or
other body lumen. An inner member may be deployable from within the
outer member that includes a proximal end, a distal end having a
size and shape for insertion into an aneurysm cavity or body lumen,
and a lumen extending between the proximal end and an outlet port
on the distal end. A source of de-endothelialization fluid may be
coupled to the proximal end of the tubular member and communicating
with the first lumen. A sealing member may be carried by one of the
inner and outer members proximal to the outlet port, the sealing
member having a size and shape for substantially sealing a neck of
the aneurysm or other body lumen.
[0032] In accordance with yet another aspect of the present
invention, a method is provided for treating a malformation
extending from a body lumen, such as an arterio-venous malformation
or fistula. A tubular member may be introduced into the body lumen
until a distal end of the tubular member is located within the
malformation. The malformation may be substantially sealed from the
body lumen, and fluid aspirated from within the malformation. For
example, the malformation may be flushed with fluid, such as
saline, and excess fluid may be aspirated from the malformation to
substantially clear the malformation. Preferably, the malformation
is flushed and aspirated substantially simultaneously.
[0033] In one embodiment, the malformation may be substantially
sealed form the body lumen by expanding an occlusion member carried
on the distal end of the tubular member to engage an entrance into
the malformation. In another embodiment, an occlusion member, such
as a compliant balloon, may be introduced into the body lumen until
the occlusion member is adjacent the malformation and then expanded
to engage an entrance to the malformation.
[0034] A therapeutic fluid may be delivered via the tubular member
into the malformation, e.g., to at least partially
de-endothelialize an endothelium of the malformation. In addition
or alternatively, the therapeutic fluid may cause at least one of
the following to occur within the malformation: cellular lysis,
disruption of cellular or intercellular adhesions, and disruption
of cellular function. Thereafter, the therapeutic fluid may be
aspirated from the malformation, e.g., by simultaneous flushing and
aspirating. If one or more occlusion members were used to seal
malformation, the occlusion member(s) may be collapsed or otherwise
removed from the body lumen, allowing the malformation to
communicate with the body lumen.
[0035] Where the malformation is an arterio-venous malformation or
fistula, e.g., extending between an artery and a vein or two other
blood vessels, an occlusion may be introduced into the artery or
first vessel to substantially isolate the artery or first vessel
from the arterio-venous malformation. Another occlusion member may
be introduced into the vein or second vessel to substantially
isolate the vein or second vessel from the arterio-venous
malformation. Thus, the malformation may be substantially isolated
from both vessels, e.g., to allow flushing, aspiration, and/or
therapeutic fluid infusion only within the malformation. Where
infusion and aspiration are simultaneous, one of the occlusion
members may be used for infusion, while the other occlusion member
may be used for aspiration.
[0036] In accordance with still another aspect of the present
invention, an apparatus is provided for disrupting an endothelium
of a wall of an aneurysm or other body lumen that includes an
elongate core member having an outer surface, a proximal end, and a
distal end having a size and shape for introduction into an
aneurysm or other body lumen. One or more fibers are provided on
the outer surface of the core member, the one or more fibers
carrying a de-endothelialization agent.
[0037] The apparatus may be used to at least partially
de-endothelialize a wall of an aneurysm or other body lumen. The
core member may be introduced into the aneurysm or other body
lumen, thereby releasing the fluid from the one or more fibers
within the aneurysm or other body lumen, the fluid disrupting at
least a portion of the endothelium of the wall of the aneurysm or
other body lumen. The core member may be dipped in a source of
de-endothelialization fluid such that the one or more fibers absorb
the fluid.
[0038] Alternatively, the core member may include a coating, e.g.,
a hydrogel, on the outer surface of the core member that is
degradable when exposed to bodily fluid, the coating including a
de-endothelialization agent that is released as the degrades.
[0039] To at least partially de-endothelialize a wall of an
aneurysm or other body lumen, the core member may be introduced
into the aneurysm. The core member may be left within the aneurysm
or other body lumen until the coating at least degrades to release
the de-endothelialization agent within the aneurysm or other body
lumen, whereby the agent may at least partially de-endothelialize a
wall of the aneurysm or other body lumen.
[0040] Other objects and features of the present invention will
become apparent from consideration of the following description
taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] The drawings illustrate the design and utility of preferred
embodiments of the present invention, in which similar elements are
referred to by common reference numerals. In order to better
appreciate how the advantages and objects of the present inventions
are obtained, a more particular description of the present
inventions briefly described above will be rendered by reference to
specific embodiments thereof, which are illustrated in the
accompanying drawings. Understanding that these drawings depict
only typical embodiments of the invention and are not therefore to
be considered limiting of its scope, the invention will be
described and explained with additional specificity and detail
through the use of the accompanying drawings.
[0042] FIG. 1 is a side view of a de-endothelialization device.
[0043] FIG. 2A-2F are details of the de-endothelialization device
of FIG. 1, showing various embodiments of an abrasive element.
[0044] FIGS. 3-11 are exemplary secondary shapes of the
de-endothelialization device of FIG. 1.
[0045] FIG. 12 is a partial cross-sectional side view of a catheter
for delivering a de-endothelialization device into an aneurysm.
[0046] FIG. 13 is a partial cross-sectional side view of a catheter
delivering a de-endothelialization device therefrom.
[0047] FIG. 14 is a partial cross-sectional side view of a catheter
delivering another de-endothelialization device therefrom.
[0048] FIG. 15 is a partial cross-sectional side view of a catheter
delivering yet another de-endothelialization device therefrom,
showing the de-endothelialization device adopting a secondary shape
as it is deployed.
[0049] FIG. 16 is a partial cross-sectional detail of a
de-endothelialization device coupled to a core wire by a mechanical
joint.
[0050] FIG. 17 is a partial cross-sectional detail of a
de-endothelialization device coupled to a core wire by an
electrolytic link.
[0051] FIG. 18 is a partial cross-sectional side view of a
de-endothelialization device coupled to a core member and being
deployed from a delivery catheter.
[0052] FIG. 19 is a partial cross-sectional side view of an
alternative embodiment of the de-endothelialization device of FIG.
18, showing the de-endothelialization device having a curvilinear
relaxed shape.
[0053] FIG. 20 is a partial cross-sectional side view of another
alternative embodiment of the de-endothelialization device of FIG.
18, showing the de-endothelialization device having a relaxed shape
of a spiral.
[0054] FIG. 21A is a top view of an embodiment of a
de-endothelialization device including a steering mechanism.
[0055] FIG. 21B is a partial cross-sectional top view of the
de-endothelialization device of FIG. 21A expanded after being
deployed from the catheter.
[0056] FIG. 22A is a side view of a de-endothelialization device
including a basket and being deployed from a delivery catheter.
[0057] FIG. 22B is a partial side view of the de-endothelialization
device of FIG. 22A expanded after being deployed from the
catheter.
[0058] FIG. 23 is a detail of a variation of the
de-endothelialization device of FIG. 22A, showing the basket
rotatably coupled to a core wire.
[0059] FIG. 24 is a side view of an alternative embodiment of the
de-endothelialization device of FIG. 22A, showing a distal end of
the core wire biased to define an angle with an axis of a proximal
portion of the core wire.
[0060] FIG. 25A is a partial cross-sectional side view of a
de-endothelialization device including a balloon and coupled to a
core wire.
[0061] FIG. 25B is a partial cross-sectional side view of a
variation of the de-endothelialization device of FIG. 25A, showing
abrasive elements forming a pattern at the distal end of the
balloon.
[0062] FIG. 26 is a side view of a de-endothelialization
device.
[0063] FIGS. 27 and 28 are partial cross-sectional side views of a
de-endothelialization delivery device, including a
de-endothelialization device having a helical coil shape when
disposed and deployed from the delivery device.
[0064] FIG. 29A is a partial cross-sectional side view of a
de-endothelialization device electrically coupled to a
generator.
[0065] FIG. 29B is a partial cross-sectional side view of a
de-endothelialization device conductively coupled to a heatable
element.
[0066] FIG. 30 is a cross-sectional side view of a
de-endothelialization device including an operative element for
delivering heat to an endothelium of an aneurysm.
[0067] FIG. 31 is a cross-sectional view of a de-endothelialization
fluid delivery device delivering fluid into an aneurysm.
[0068] FIG. 32 is a cross-sectional detail of a variation of the
de-endothelialization fluid delivery device of FIG. 31.
[0069] FIG. 33A is a cross-sectional detail of another variation of
the de-endothelialization fluid delivery device of FIG. 31
including a drainage port.
[0070] FIG. 33B is a cross-sectional detail of a variation of the
de-endothelialization fluid delivery device of FIG. 33A.
[0071] FIG. 33C is a cross-sectional detail of another variation of
the de-endothelialization fluid delivery device of FIG. 33A.
[0072] FIG. 33D is a cross-sectional detail of yet another
variation of the de-endothelialization fluid delivery device of
FIG. 33A including an inner tube.
[0073] FIG. 34A is a cross-sectional detail of another variation of
the de-endothelialization fluid delivery device of FIG. 32
including a stopper.
[0074] FIG. 34B is a detail of the de-endothelialization fluid
delivery device of FIG. 34A, showing the stopper in a low profile
disposed within a sheath.
[0075] FIG. 34C is a detail of a variation of the
de-endothelialization fluid delivery device of FIG. 34A including a
stopper.
[0076] FIG. 34D is a detail of the de-endothelialization fluid
delivery device of FIG. 34C, showing the stopper compressed into a
low profile within a sheath.
[0077] FIG. 34E is a partial cross-sectional side view of the
de-endothelialization fluid delivery device of FIG. 34A, showing
the stopper being deployed within an aneurysm.
[0078] FIG. 34F is a cross-sectional side view of a variation of
the de-endothelialization fluid delivery device of FIG. 34A,
showing a stopper having an elliptical shape.
[0079] FIG. 35 is a partial cross-sectional side view of an
alternative embodiment of a de-endothelialization fluid delivery
device.
[0080] FIG. 36 is a partial cross-sectional side view of a
variation of the de-endothelialization fluid delivery device of
FIG. 35.
[0081] FIG. 37 is a partial cross-sectional side view of a
variation of the de-endothelialization fluid delivery device of
FIG. 36.
[0082] FIG. 38A is a partial side view of a de-endothelialization
fluid delivery device including a balloon deployed within an
aneurysm.
[0083] FIG. 38B is a cross section of the de-endothelialization
fluid delivery device of FIG. 38A.
[0084] FIG. 39A is a cross-sectional view of a variation of the
de-endothelialization fluid delivery device of FIG. 38A including a
balloon having a drainage port.
[0085] FIG. 39B is a cross sectional view of the delivery tube of
the de-endothelialization fluid delivery device of FIG. 39A taken
along line 39B-39B.
[0086] FIG. 40A is a cross section of a variation of the
de-endothelialization fluid delivery device of FIG. 39A including a
drainage port coupled to a drainage tube.
[0087] FIG. 40B is a cross sectional view of the delivery tube of
the de-endothelialization fluid delivery device of FIG. 40A taken
along line 40B-40B.
[0088] FIG. 41 is a cross-sectional view of a variation of the
de-endothelialization fluid delivery device of FIG. 38A including a
stopper.
[0089] FIG. 42 is a side view of a de-endothelialization fluid
delivery device including a triple-lumen catheter.
[0090] FIG. 42A is a cross-sectional view of another variation of
the de-endothelialization fluid delivery device of FIG. 38A,
including a fluid delivery lumen formed within a wall of the
balloon for delivering de-endothelialization fluid.
[0091] FIG. 42B is a cross-sectional view of another variation of
the de-endothelialization fluid delivery device of FIG. 38A
including a separate tube coaxially surrounded by the delivery
tube.
[0092] FIG. 43A is a side view of a de-endothelialization system
including a perfusion balloon.
[0093] FIG. 43B is a perspective view of a variation of the
perfusion balloon of the de-endothelialization system of FIG.
43A.
[0094] FIG. 43C is a cross sectional view of the perfusion balloon
of FIG. 43B taken along line 43C-43C.
[0095] FIG. 44A is a side view of a de-endothelialization fluid
delivery device including a triple-lumen catheter.
[0096] FIG. 44B is a cross sectional view of the triple-lumen
catheter of FIG. 44A taken along line 44B-44B.
[0097] FIG. 44C is a cross-sectional view of a variation of the
triple-lumen catheter of FIG. 44A.
[0098] FIG. 44D is a cross-sectional view of another variation of
the triple-lumen catheter of FIG. 44A.
[0099] FIG. 45 is a side view of a de-endothelialization fluid
delivery device including an expandable applicator deployable from
a delivery sheath.
[0100] FIG. 46 is a partial cross-sectional view of the
de-endothelialization fluid delivery device of FIG. 45, showing the
applicator compressed into a low profile within the sheath.
[0101] FIG. 47 is a side view of a de-endothelialization device
including a fiber attached to an elongate core member.
[0102] FIG. 48 is a side view of a variation of the
de-endothelialization device of FIG. 47.
[0103] FIG. 49 is a side view of another variation of the
de-endothelialization device of FIG. 47.
[0104] FIG. 50 is a cross-sectional side view of a
de-endothelialization device including a coating containing a
de-endothelializing compound therein.
[0105] FIG. 51 is a cross-sectional side view of a
de-endothelialization device including a hydrogel coating on an
elongate core member.
[0106] FIGS. 52A-52E show a blood vessel with an aneurysm being
treated using a dual catheter system, in accordance with the
present invention.
[0107] FIG. 53 is a cross-sectional side view of a dual syringe
system for simultaneously injecting and aspirating fluid, in
accordance with the present invention.
[0108] FIG. 54 shows an arterio-venous malformation being treated
using a dual catheter system, in accordance with the present
invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0109] Systems and methods of de-endothelializing an aneurysm or
other body lumen are described herein. As used in this
specification, "de-endothelializing" or "de-endothelialization"
refers to the process of disrupting an endothelium of an aneurysm
or other body lumen, which includes removing, damaging physically,
damaging normal biochemical function, or otherwise damaging and/or
destroying a part or all of the endothelium of the wall of an
aneurysm or other body lumen. The first part of the specification
discusses systems and methods of de-endothelializing an aneurysm or
other body lumen using mechanical instrumentality. The second part
of the specification discusses systems and methods of
de-endothelializing an aneurysm or other body lumen using a thermal
treatment. The third part of the specification discusses systems
and methods of de-endothelializing an aneurysm or other body lumen
using a fluid.
I. De-Endothelialization Using Mechanical Instrumentality
[0110] A. Implantable De-Endothelialization Devices
[0111] FIGS. 1-11 show variations of a de-endothelialization device
10. The de-endothelialization device 10 includes a core member 12
and one or more abrasive elements 14 coupled to the core member 12.
In general, the core member 12 carries the abrasive element(s) 14,
which are adapted for disrupting an endothelium of an aneurysm.
Optionally, the de-endothelialization device 10(1) may include an
end cap 18, as shown in FIG. 1, e.g., a rounded and/or
substantially blunt distal tip.
[0112] FIG. 1 shows a de-endothelialization device 10(1) that has
an elongate core member 12(1) adapted to be implanted within an
aneurysm. The core member 12(1) preferably has a circular
cross-sectional shape. Alternatively, the core member 12(1) may
have a rectangular, a triangular, or other geometric
cross-sections. The core member 12(1) may even have an irregular
shaped cross-section.
[0113] The core member 12(1) is preferably made of biodegradable
materials. Biodegradable or absorbable materials suitable for use
in the compositions of the core member 12(1) may include polymers
and proteins. Suitable polymers include, for example, polyglycolic
acid, polylactic acid, polycaprolactone, polyhydroxybutyrate,
polyhydroxyvalerate, polydioxanone, polycarbonates, polyanhydrides,
polyhydroxyalkanoates, polyarylates, polysaccharides, polyamino
acids, and copolymers thereof. Non-limiting examples of
bioabsorbable proteins include collagen, elastin, fibrinogen,
fibronectin, vitronectin, laminin and gelatin. Many of these
materials are commercially available. Fibrin-containing
compositions are commercially available, for example, from Baxter.
Collagen containing compositions are commercially available, for
example, from Cohesion Technologies, Inc., Palo Alto, Calif.
Fibrinogen-containing compositions are described, for example, in
U.S. Pat. Nos. 6,168,788 and 5,290,552, the entirety of which is
expressly incorporated by reference herein. As will be readily
apparent, absorbable materials can be used alone or in any
combination with each other. The absorbable material may be in the
form of a mono-filament or, alternatively, multi-filament
strands.
[0114] Furthermore, the absorbable materials may be used in
combination with additional components. For example, lubricious
materials (e.g., hydrophilic) materials may be used to coat the
member. One or more bioactive materials may also be included in the
composition of the core member 12(1). The term "bioactive" refers
to any agent that exhibits effects in vivo, for example, a
thrombotic agent, a therapeutic agent, and the like. Examples of
bioactive materials include cytokines; extra-cellular matrix
molecules (e.g., collagen); trace metals (e.g., copper); matrix
metalloproteinase inhibitors; and other molecules that stabilize
thrombus formation or inhibit clot lysis (e.g., proteins or
functional fragments of proteins, including but not limited to
Factor XIII, .alpha..sub.2-antiplasmin, plasminogen activator
inhibitor-1 (PAI-1) or the like). Examples of cytokines that may be
used alone or in combination in practicing the present invention
include basic fibroblast growth factor (bFGF), platelet derived
growth factor (pDGF), vascular endothelial growth factor (VEGF),
transforming growth factor beta (TGF-.beta.), and the like.
Cytokines, extra-cellular matrix molecules, and thrombus
stabilizing molecules are commercially available from several
vendors such as Genzyme (Framingham, Mass.), Genentech (South San
Francisco, Calif.), Amgen (Thousand Oaks, Calif.), R&D Systems,
and Immunex (Seattle, Wash.). Additionally, bioactive polypeptides
can be synthesized recombinantly as the sequence of many of these
molecules are also available, for example, from the GenBank
database. Thus, it is intended that the invention include use of
DNA or RNA encoding any of the bioactive molecules.
[0115] Furthermore, it is intended that molecules having similar
biological activity as wild-type or purified cytokines, matrix
metalloproteinase inhibitors, extra-cellular matrix molecules,
thrombus-stabilizing proteins (e.g., recombinantly produced or
mutants thereof), and nucleic acid encoding these molecules may
also be used. The amount and concentration of the bioactive
materials that may be included in the composition of the core
member 12(1) may vary, depending on the specific application, and
can be readily determined by one skilled in the art. It will be
understood that any combination of materials, concentration, or
dosage can be used so long as it is not harmful to the subject.
[0116] For the compositions of the core member 12(1), it may also
be desirable to include one or more radiopaque materials for use in
visualizing the vaso-occlusive members 12(1) in situ. Thus, the
vaso-occlusive members 12(1) may be coated or mixed with radiopaque
materials such as metals (e.g. tantalum, gold, tungsten or
platinum), barium sulfate, bismuth oxide, bismuth subcarbonate, and
the like.
[0117] Alternatively, the core member 12(1) may be made of
non-biodegradable materials, such as metals or alloys, for
examples, that are in general more elastic than the biodegradable
materials described previously. Suitable metals and alloys for the
wire making up the coil include the Platinum Group metals,
especially platinum, rhodium, palladium, rhenium, as well as
tungsten, gold, silver, tantalum, and alloys of these metals. These
metals have significant radiopacity and their alloys may be
tailored to accomplish an appropriate blend of flexibility and
stiffness. They are also largely biologically inert. Additional
coating materials, such as polymer, or biodegradable materials as
discussed previously, may be added to the surface of the core
member 12(1) to improve the lubricity, healing properties, or
thrombogenic properties of the vaso-occlusive device.
[0118] The core member 12(1) may also be of any of a wide variety
of stainless steels if some sacrifice of radiopacity may be
tolerated. Very desirable materials of construction, from a
mechanical point of view, are materials that maintain their shape
despite being subjected to high stress. Certain "super-elastic
alloys" include nickel/titanium alloys, copper/zinc alloys, or
nickel/aluminum alloys. Alloys that may be used are also described
in U.S. Pat. Nos. 3,174,851, 3,351,463, and 3,753,700, the entirety
of which is expressly incorporated by reference herein.
[0119] Titanium/nickel alloys known as "nitinol" may also be used
in the core member 12(1). These are super-elastic and very sturdy
alloys that will tolerate significant flexing without deformation
even when used as a very small diameter wire. If nitinol is used in
the device, the diameter of the core member 12(1) may be
significantly smaller than that of a core member 12(1) that uses
the relatively more ductile platinum or platinum/tungsten alloy as
the material of construction.
[0120] The core member 12(1) may also be made of radiolucent fibers
or polymers (or metallic threads coated with radiolucent or
radiopaque fibers) such as Dacron (polyester), polyglycolic acid,
polylactic acid, fluoropolymers (polytetrafluoroethylene), Nylon
(polyamide), or even silk.
[0121] The abrasive element(s) 14 may have a sharp edge (such as
that of a cutting wire or a knife) or a sharp point, for the
purpose of cutting, abrading, and/or penetrating an endothelium of
an aneurysm. FIG. 2 shows several examples of the shape of the
abrasive element(s) 14. The abrasive element 14 can have a shape of
a hook (FIG. 2A), a needle (FIG. 2B), a fin (FIG. 2C), a saw tooth
(FIG. 2D), a multi-branch hook (FIG. 2E), or a ninety degree hook
(FIG. 2F). The abrasive element(s) 14 can also include one or more
sharp particles, such as diamond dust, that has no specific
geometric shape. It should be noted that the abrasive element(s) 14
can also have a customized shape or other shapes as well. The
abrasive element(s) 14 can have a wide range of stiffness, so long
as the abrasive element(s) 14 is capable of disrupting an
endothelium of an aneurysm. Furthermore, in order to prevent
over-thinning of the arterial or aneurysm wall, that can risk
punctures of the arterial or aneurysm wall, the abrasive element
14(s) may have an overall depth that is less than about five
microns. Depending on the particular application, the abrasive
element(s) 14 may also have an overall depth that is more than
about five microns.
[0122] As a further alternative, the abrasive element 14 may be an
abrasive fibrous structure having fibers adapted for disrupting an
endothelium of an aneurysm. The fibrous structure is preferably
coupled to the core member 12 by frictional contact between the
fibrous structure and the outer surface of the core member 12. The
surface of the core member 12 may be textured to improve coupling
between the fibrous structure and the core member 12. The core
member 12 may also include one or more transverse openings along
the length of the core member 12, through which strands of the
fibrous structure can be wrapped to secure the fibrous structure to
the core member 12. Alternatively, the core member 12 may also
include protrusions along the length of the core member 12, around
which strands of the fibrous structure can be wrapped or hooked to
secure the fibrous structure to the core member 12. Alternatively,
an adhesive, such as ultraviolet-curable adhesives, silicones,
cyanoacrylates, and epoxies, may be used to secure the fibrous
structure to the core member 12. Furthermore, the fibrous structure
may be coupled to the core member 12 by chemical bonding between
reactive groups on the fibrous structure and the core member 12,
fusing both materials so that they melt together, or temporarily
melting the surface of the core member 12 to embed strands of the
fibrous structure.
[0123] The abrasive element 14 can be made from a variety of
materials, such as polymers, metals, or plastics. Any of the
materials discussed previously in reference to the core member 12
may also be suitable for the abrasive element 14. The abrasive
element 14 can be coupled to the core member 12 by a polymer, glue,
weld, or brazing. Other types of adhesive may also be used,
depending on the materials from which the abrasive element 14 and
the core member 12 are made. Alternatively, the abrasive element 14
and the core member 12 can be fabricated together as a single unit
during a manufacturing process. For example, the abrasive element
14 can be created by removing part(s) of the surface of the core
member 12. The abrasive element 14 may also be molded together with
the core member 12 when the de-endothelialization device 10 is
manufactured. It should be noted that the number of abrasive
elements 14, and the patterns or configurations formed by the
abrasive elements 14, on the surface of the core member 12 may
vary. For example, the de-endothelialization device 10 can have a
single or a plurality of abrasive elements 14. Furthermore, the
core member 12 can be completely or partially covered by the
abrasive element(s) 14 in a random or designed pattern.
[0124] The de-endothelialization device 10(1) described above
generally has a substantially rectilinear or a curvilinear
(slightly curved, i.e. having less than 360.degree. spiral) relaxed
configurations. This configuration may be referred to as a "primary
shape," i.e., referring to the basic shape of the device material.
Such a device may assume folded configurations when they are
subjected to an external force, e.g., buckling or compressive
forces when they encounter objects.
[0125] In addition or alternatively, the vaso-occlusive device may
include a "secondary relaxed shape," which may be formed by
wrapping a core member having a primary shape that is substantially
linear around a shaping element. The secondary shape may be a
helical coil or other shapes.
[0126] In addition or as a further alternative, the vaso-occlusive
device may also assume a "tertiary relaxed shape," which may be
formed, for example, by wrapping a core member having a primary or
secondary shape around a shaping element. The tertiary shape may
be, for example, in a shape of a clover leaf, a twisted figure
eight, a flower, a sphere, a vortex, an ovoid, or random
shapes.
[0127] A secondary and/or tertiary shape may be programmed into a
device using known heat treatment processes or other shape memory
material properties. Once programmed, the device may be biased to a
"relaxed state" including both a primary shape, secondary, and/or
tertiary shape. This relaxed state may also be referred to as a
lowest energy state, because, when the device is deformed into any
other shape, it may store elastic energy that is removed as the
device returns towards the relaxed state.
[0128] For a device that has a secondary and/or tertiary shape, the
core member 12 is preferably made from a substantially resilient
material, having sufficient rigidity to support the
de-endothelialization device in the secondary and/or tertiary state
when deployed, e.g., within an aneurysm or other body space. Thus,
the space-filling capacity of these devices may be inherent within
the secondary and/or tertiary relaxed shapes of these devices.
[0129] FIGS. 3 and 4 illustrates de-endothelialization devices 10
having secondary shapes. These shapes are simply indicative of the
various secondary shapes that may be used, and other shapes may be
used as well. The device 10 illustrated in each of the FIGS. 3 and
4 includes the abrasive element 14 as described previously, but is
not shown for clarity.
[0130] FIG. 3 depicts a de-endothelialization device 10(2) having a
secondary shape of a helical coil. The helical coil can have an
open pitch, such as that shown in FIG. 3, or a closed pitch. FIG. 4
illustrates a de-endothelialization device 10(3) having a random
secondary shape. Each of the secondary shapes shown in FIGS. 3 and
4 may be achieved by wrapping a core member 12 having a primary
shape that is substantially linear, such as that shown in FIG. 1,
around a mandrel, stylet, or other shaping element. The device 10
may be subjected to a heat treatment or other step known to those
skilled in the art for setting the secondary shape of the device
10. Forming devices, such as vaso-occlusive devices, into secondary
shapes is well known in the art, and need not be described in
further detail.
[0131] FIGS. 5-11 illustrate various de-endothelialization devices
10 of this invention having a secondary shape of a helical coil,
such as that shown in FIG. 3, and a tertiary shape. These shapes
are simply indicative of the various tertiary shapes that may be
used, and other shapes may be used as well. While not shown, the
devices 10 illustrated in each of the FIGS. 5-11 include the
abrasive element 14, as discussed previously.
[0132] FIG. 5 depicts a device 10(4) having a tertiary shape of a
clover leaf. FIG. 6 depicts a device 10(5) having a tertiary shape
of a twisted figure-8. FIG. 7 depicts a device 10(6) having a
flower-shaped tertiary shape. FIG. 8 depicts a device 10(7) having
a substantially spherical tertiary shape. FIG. 9 illustrates a
device 10(8) having a random tertiary shape. FIG. 10 illustrates a
device 10(9) having tertiary shape of a vortex. FIG. 11 illustrates
a device 10(10) having a tertiary shape of an ovoid. It should be
noted that de-endothelialization device 10 may also have other
secondary and tertiary shapes, and should not be limited to the
examples illustrated previously. For example, the core member 12,
and accordingly, the de-endothelialization device, can be
selectively sized to fill a particular aneurysm.
[0133] To make the tertiary shaped de-endothelialization devices
10, a core member 12 that is substantially rectilinear or
curvilinear may be wrapped around a mandrel or other shaping
element to form a secondary shape, such as the helical coil shown
in FIG. 3. The mandrel and the core member 12 may be heated to
shape the core member 12 into the secondary shape. The secondary
shaped core member 12, or as in the case for the devices shown in
FIGS. 5-11, the helical coil, is then wrapped around another
shaping element to produce the tertiary shape. Heat may also be
used to shape the core member 12 to form the tertiary shape. Stable
coil designs, and methods of making such, are described in U.S.
Pat. No. 6,322,576B1 to Wallace et al., the entirety of which is
expressly incorporated by reference herein. It should be noted that
forming devices, such as vaso-occlusive devices, into secondary and
tertiary shapes is well known in the art, and need not be described
in further detail.
[0134] The method of using the previously described
de-endothelialization devices will now be discussed with reference
to FIGS. 12-15. First, a delivery catheter 42 is inserted into the
body of a patient, e.g., percutaneously through a peripheral
vessel, such as a femoral, carotid, or radial artery. Other entry
sites sometimes are well known to physicians who practice these
types of medical procedures. The delivery catheter 42, which may be
a micro-catheter, sheath, or other elongate device, is positioned
so that the distal end 48 of the delivery catheter 42 is
appropriately situated, e.g., within the mouth of the body cavity
41 to be treated. The delivery catheter 42 may be advanced over or
otherwise in conjunction with a guidewire, guiding catheter, or
other rail, as is known in the art. In addition, the catheter 42
may be monitored, e.g., using fluoroscopy, during advancement.
[0135] Once the delivery catheter 42 is in place, the
de-endothelialization device 10 may be inserted from the proximal
end (not shown) of the delivery device 42 into a lumen of the
delivery catheter 42. If desired, the de-endothelialization device
10 can be heated, e.g., to a temperature above 50.degree. C., or
cooled, e.g., to a temperature below 0.degree. C., to enhance the
de-endothelializing property of the de-endothelialization device
10. The endothelium of the aneurysm or other body lumen can be
injured or destroyed simply by heating, e.g., to a temperature
above 50.degree. C., or cooling, e.g., to a temperature below
0.degree. C., as explained further below.
[0136] For a de-endothelialization device, such as the device 10
shown in FIG. 1 having no secondary shape, the
de-endothelialization device 10 may naturally assume its
substantially rectilinear or a curvilinear primary shape when
disposed within the lumen of the delivery catheter 42, without
being subjected to substantial stress. When the
de-endothelialization device 10 is disposed within the lumen of the
delivery catheter 42, the abrasive element(s) 14 may assume a bent
or collapsed configuration. Alternatively, the lumen of the
delivery catheter 42 can be made sufficiently wide to accommodate
the de-endothelialization device 10 without substantially bending
the abrasive element(s) 14. For de-endothelialization devices
having secondary and/or tertiary shapes, such as the
de-endothelialization devices shown in FIGS. 3-11, they may be
"stretched" or straightened to a substantially linear shape primary
or secondary shape while residing within the lumen of the delivery
catheter 42, as illustrated with the de-endothelialization device
10 in FIG. 13. A de-endothelialization device that can assume a
linear shape within the delivery device 42 may substantially reduce
the cross-sectional dimension required of the delivery catheter 42,
which may assist advancing the catheter 42 into the body of a
patient and improves the maneuverability of the catheter 42 within
the body, e.g., through narrow vessels and/or tortuous anatomy.
[0137] Alternatively, as shown in FIG. 14, a de-endothelialization
device having a secondary shape of a helical coil, such as the
de-endothelialization device 10, may be disposed within the lumen
of a delivery catheter in an unstretched configuration.
Furthermore, as shown in FIG. 15, a de-endothelialization device
having a secondary shape made of a helical coil, such as the
de-endothelialization device 10, may be "stretched" from its
tertiary shape into a substantially linear helical coil, when
disposed within the lumen of a delivery catheter 42.
[0138] Referring back to FIG. 12, the de-endothelialization device
10 is preferably advanced distally towards the distal end 48 of the
delivery catheter 42 using a core wire or pusher member 44. A
plunger 46 may be attached to the distal end of the core wire 44 to
assist advancing the de-endothelialization device 10.
Alternatively, fluid pressure may also be used to advance the
de-endothelialization device 10 along the delivery catheter 42. The
inner diameter of the delivery catheter 42 should be made large
enough to allow advancement of the de-endothelialization device 10.
On the other hand, the inner diameter of the delivery catheter 42
should not be significantly larger than the overall cross-sectional
dimension of the de-endothelialization device 10 in order to avoid
bending and kinking of the de-endothelialization device 10 within
the lumen of the delivery catheter 42.
[0139] For a de-endothelialization device having no secondary
relaxed shape or having a secondary shape that is substantially
rectilinear or curvilinear, such as a substantially linear helical
coil, the de-endothelialization device may remain substantially
rectilinear or curvilinear without undergoing substantial stress
while disposed within the lumen of the delivery catheter 42. Once
the de-endothelialization device 10 or a portion of the
de-endothelialization device 10 exits from the distal end 48 of the
delivery catheter 42, it may remain substantially rectilinear or
curvilinear until it contacts an object, e.g., the wall of the body
cavity 41. If the de-endothelialization device 10 is advanced
further distally, i.e., to introduce additional length into the
body cavity, the de-endothelialization device 10 may buckle and/or
bend due to the distal force exerted by the device against the
object that it contacts. Consequently, the de-endothelialization
device 10 may fold, thereby forming a three-dimensional structure
for occupying the aneurysm. For de-endothelialization devices
having secondary and/or tertiary shapes, the de-endothelialization
device may attempt to assume its relaxed secondary and/or tertiary
shape when ejected from the lumen of the delivery catheter 42. The
shape of the secondary and/or tertiary shapes may help fill the
body cavity 41.
[0140] Optionally, one or more additional de-endothelialization
devices 10 may also be placed within the body cavity 41 by
repeating the relevant steps discussed above. When a desired number
of de-endothelialization devices have been placed within the body
cavity 41, the delivery catheter 42 is then withdrawn from the body
cavity 41.
[0141] During and/or after placing the de-endothelialization
devices 10 in the body cavity 41, the abrasive element(s) 14 of the
de-endothelialization device(s) may disrupt the endothelium of the
aneurysm, blood vessel, or other body lumen, causing the lumen wall
to produce a fibro-proliferative reaction. As a result, fibrous
tissue containing collagen may form at the disrupted endothelium,
thereby thickening the wall of the aneurysm or body lumen. The
thickening of the wall of the aneurysm or body lumen may reduce the
risk of rupturing and/or growth of the aneurysm, thereby enhancing
stabilization of the aneurysm, and/or enhancing stable occlusion of
the aneurysm or body lumen. Eventually, an embolism may form to
occlude the body cavity 41.
[0142] FIG. 16 depicts an embodiment, generally designated 60,
having a de-endothelialization device 10 that may be detached from
a core wire 44 using a mechanical joint 64. The
de-endothelialization device 10 may be any one of the devices
depicted in FIGS. 1-11 and described above, including one or more
abrasive elements 14 (not shown for clarity). Joint 64 has a clasp
section 66 that remains attached to the core wire 44 when sheath or
catheter body 42 is retracted proximally. Joint 64 also includes a
second clasp section 68 that is carried on the proximal end of the
de-endothelialization device 10 and interlocks with clasp section
66 when the assembly is within sheath 42. When the sheath 42 is
withdrawn from about the assembly, the clasp sections are free to
disengage, thus detaching the de-endothelialization device 10. Core
wire 44 may be electrically connected to a source of radiofrequency
energy.
[0143] The de-endothelialization devices 10 described herein may
also be non-detachable or detachable by electrolytic joints or
connectors, such as those described in U.S. Pat. Nos. 5,234,437,
5,250,071, 5,261,916, 5,304,195, 5,312,415, and 5,350,397, the
entireties of which are expressly incorporated by reference
herein.
[0144] FIG. 17 shows an embodiment, generally designated 70, having
a de-endothelialization device 10 that may be detached from a core
wire 44 using a joint 74 susceptible to electrolysis. The
de-endothelialization device 10 may be any one of the devices
depicted in FIGS. 1-11 and described above, including one or more
abrasive elements 14 (not shown for clarity). Such joints are
described in detail in U.S. Pat. No. 5,423,829, the entirety of
which is expressly incorporated by reference herein. Joint 74 may
be made of a metal that, upon application of a suitable voltage to
the core wire 44, may erode in the bloodstream, thereby allowing
the de-endothelialization device 10 to detach. The
de-endothelialization device 10 may be made of a metal that is more
"noble" in the electromotive series than the metal of joint 74. A
return electrode (not shown) may be supplied to complete the
circuit, as is well know to those skilled in the art. The region of
core wire 44 proximal to the joint 74 may be insulated to focus the
erosion at the joint 74. An electrically conductive bushing 76 is
used to connect the distal end of core wire 44 to the proximal end
of the de-endothelialization device 10.
[0145] For a de-endothelialization device 10 that is detachably
coupled to the core wire 44 (such as those illustrated in FIGS. 16
and 17), the de-endothelialization device 10 may be moved, i.e.,
advanced, retracted, and/or rotated, within the aneurysm or other
body lumen by manipulating (i.e., advancing, retracting, and/or
rotating) the proximal end of the core wire 44. Moving the
de-endothelialization device 10 within the aneurysm or other body
lumen may increase the surface area of the endothelium disrupted by
the abrasive element(s) 14 of the de-endothelialization device 10.
After the endothelium of the aneurysm or other body lumen has been
sufficiently disrupted, the de-endothelialization device 10 may be
de-coupled from the core wire 44. If desired, one or more
additional de-endothelialization device(s) 10 may be inserted into
the aneurysm or other body lumen, as discussed previously.
[0146] Although, the de-endothelialization device 10 described
previously is adapted to be implanted in a body cavity, such needs
not be the case. After the endothelium of the aneurysm or other
body lumen has been disrupted, the de-endothelialization device 10
may be removed from the aneurysm or other body lumen by retracting
the proximal end of the core wire 44, thereby causing the
de-endothelialization device 10 to move back into the lumen of the
catheter body 42. As such, the de-endothelialization device 10 may
be used as a tool without being implanted in a body cavity.
Thereafter, one or more vaso-occlusive devices may be delivered to
fill the aneurysm or other body lumen. If the aneurysm or other
body lumen is small, the de-endothelialization of the aneurysm may
cause the wall to thicken enough to occlude the aneurysm or other
body lumen without using a vaso-occlusive device.
De-endothelialization devices not intended for implantation are
described further below.
[0147] B. Non-Implantable De-Endothelialization Devices
[0148] FIGS. 18-24 show variations of a de-endothelialization
device 100 that is adapted to be removed from an aneurysm or other
body lumen after an endothelium of the aneurysm or other body lumen
has been disrupted.
[0149] FIG. 18 shows a de-endothelialization device 100(1) having a
core member 102 and one or more abrasive elements 104 coupled to
the core member 102. The abrasive element(s) 104 may be any of the
variations of the abrasive element 14 discussed previously. Any of
the materials discussed previously with reference to the core
member 12 may also be used to construct the core member 102. The
core member 102 is preferably detachably coupled to a distal end
112 of an elongate member, such as a core wire or a pusher member
114. Thus, if the core member 102 becomes irretrievable during a
procedure, the core member 102 can be decoupled from the elongate
member 114, and left within the aneurysm or other body lumen as an
implant. Alternatively, the core member 102 may be secured to the
distal end 112 of the elongate member 114 by a suitable adhesive,
which may depend upon the materials from which the elongate member
114 and the core member 102 are made. The core member 102 may also
be fabricated together with the elongate member 114 as one unit
during manufacturing. In this case, the core member 102 would
include the elongate member 114. A handle 116 may optionally be
secured to a proximal end 118 of the elongate member 114.
[0150] The core member 102 and/or the distal end 112 of the
elongate member 114 may assume a substantially linear shape, such
as that shown in FIG. 18. Alternatively, the core member 102 may
also assume a relaxed configuration that has a curvilinear shape,
such as a J-shape (FIG. 19), a spiral (FIG. 20), or other designed
shapes. In general, any of the shapes discussed previously with
reference to FIGS. 1-11 may also be used for the core member 102.
Although not required, the de-endothelialization device 100(1) may
optionally include a tubular element 120 (such as a sheath or a
catheter) capable of coaxially surrounding the core member 102
during a procedure. The core member 102 and/or the distal end 112
of the elongate member 114 assumes a low profile configuration when
disposed within a lumen 122 of the tubular element 120. If the core
member 102 and/or the distal end 112 of the elongate member 114 has
a non-linear relaxed configuration, the core member 102 and/or the
distal end 102 may assume its relaxed configuration when deployed
from the tubular element 120.
[0151] Turning to FIG. 21A, optionally, the de-endothelialization
device 100 may include a steering mechanism 130 for changing the
shape of the distal end 112 of the elongate member 104. The
steering mechanism 130 can vary. For example, FIG. 21 shows a
steering mechanism as disclosed in U.S. application Ser. No.
07/789,260, now U.S. Pat. No. 5,363,861 issued Nov. 15, 1994, the
entirety of which is expressly incorporated by reference herein. As
FIG. 21B shows, the steering mechanism 130 may include a rotating
cam wheel 132 within the handle 116, and an external steering lever
or control (not shown) may rotate the cam wheel 132. The cam wheel
132 holds the proximal ends of right and left steering wires 136
and 138. The steering wires 136 and 138 may extend along the
associated left and right side surfaces of the cam wheel 132 and
through the guide tube 140. The steering wires 136 and 138 connect
to left and right sides of a resilient bendable wire or spring
within a distal section of the elongate member 104. Alternatively,
the steering wires 136 and 138 may connect to a portion of the core
member 102.
[0152] As FIG. 21A shows, manipulating the steering lever or
control causes the distal end 112 of the elongate member 104 and/or
the core member 102 to bend up or down. By rotating the handle,
thereby bending the distal end 112 of the elongate member 104, and
by manipulating the steering lever, it is possible to maneuver the
distal end 112 of the elongate member 104 virtually in any
direction. The steerable section simplifies the positioning of the
distal end 102, and accordingly, the core member 102 of the
de-endothelialization device 100.
[0153] When using the de-endothelialization device 100, the distal
end 112 (including the de-endothelialization device 100) of the
elongate member 104 is first positioned inside an aneurysm or other
body lumen. Positioning the distal end 112 of the elongate member
104 may be facilitated using a guide wire and/or sheath (such as
the tubular element 120), as is known to those skilled in the art.
If desired, the de-endothelialization device 100 may be heated or
cooled to a certain temperature to enhance the de-endothelializing
capability of the de-endothelialization device 100, as discussed
previously. Next, by manipulating (i.e., advancing, retracting,
and/or turning) the proximal end 118 of the elongate member 104 (or
the handle 116 if one is provided), the core member 102 of the
de-endothelialization device 100 may be positioned at various
locations against the endothelium of the aneurysm or other body
lumen, thereby disrupting the endothelium of the various locations
of the aneurysm or other body lumen. If a steering mechanism 130 is
provided, the steering mechanism 130 may also be used to position
the core member 102 of the de-endothelialization device 100.
[0154] After the abrasive element 104 of the de-endothelialization
device 100 has disrupted sufficient surface area of the endothelium
of the aneurysm or other body lumen, the de-endothelialization
device 100 may be withdrawn from the aneurysm or other body lumen.
After some time, fibrous tissue may form at the disrupted
endothelium, causing the wall of the aneurysm or other body lumen
to thicken, as discussed above with reference to implantable
de-endothelialization devices. For an aneurysm or other body lumen
having a certain size, it may be desirable to deliver one or more
vaso-occlusive device(s) into the aneurysm or other body lumen
after the de-endothelialization device 100 has been removed from
the aneurysm or other body lumen. Alternatively, if the aneurysm or
other body lumen is small, the de-endothelialization of the
aneurysm or other body lumen may cause the wall to thicken enough
to occlude the aneurysm or other body lumen without requiring a
vaso-occlusive device to be implanted.
[0155] In certain situations, it may be desirable to disrupt the
neck of an aneurysm, with or without de-endothelializing the wall
of the aneurysm sac. For example, when the neck of an aneurysm is
small, de-endothelializing just the neck may cause the neck of the
aneurysm to thicken, thereby closing the neck. For a wide neck
aneurysm, de-endothelializing the neck of the aneurysm may have the
benefit of reducing the size of the neck. It should be noted that
the embodiments of de-endothelialization devices described above
may also be suitable for disrupting the neck of an aneurysm, and
that the methods described above may be used for this purpose.
[0156] FIGS. 22-24 show variations of a de-endothelialization
device 100, including an expandable member coupled to a core wire
or other elongate member 114. FIG. 22A shows a
de-endothelialization device 100(2) including one or more abrasive
elements 104, and an expandable basket 150. Although the expandable
basket 150 is shown to include two flexible wires 152, it may
include any number of wires 152. Furthermore, the basket 150 is not
necessarily limited to the example illustrated in FIG. 22.
Alternatively, the basket 150 may include a braided structure or a
mesh. The basket 150 is preferably made of an elastic material,
such as nitinol, although other materials may also be used. The
distal end of the basket 150 may be secured to the elongate member
114 such that rotating the proximal end 118 of the elongate member
114 may cause the expandable basket 150 to rotate. Alternatively,
as shown in FIG. 23, the distal end of the expandable basket 150
may be rotatably secured to the elongate member 114 so that the
basket 150 can rotate about the elongate member 114. In either
case, the basket 150 may be rotated manually or automatically,
e.g., by a machine.
[0157] As shown in FIGS. 22A and 22B, the basket 150 may assume a
low or collapsed profile while disposed within the lumen of the
tubular element 120, and is free to assume an expanded profile when
it is outside the tubular element 120. The basket 150 may be
self-expanding or self-collapsing. A self-expanding basket has a
relaxed expanded configuration, and may be collapsed by directing
opposite ends 154 and 156 of the wires 152 (or the elements
defining the basket 150) further from one another. A
self-collapsing basket has a relaxed collapsed (or unexpanded)
configuration, and may be expanded by directing opposite ends 154
and 156 of the wires 152 (or the elements defining the basket 150)
closer towards one another. The shape of the basket 150 may be
changed, for example, by varying the tension or compression on any
or all of the wires 152 via a control (not shown). FIGS. 22A and
22B show that the elongate member 114 is substantially linear.
Alternatively, as shown in FIG. 24, the distal end 112 of the
elongate member 114 may be bent or preformed such that it forms an
angle 160 with an axis 162 of a proximal portion of the elongate
member 114. Expandable baskets that may be used are described in
U.S. Pat. Nos. 5,893,847, 5,925,038, and 6,216,044, the disclosures
of which are expressly incorporated by reference herein.
[0158] FIG. 25A shows a de-endothelialization device 100(3) that
includes a plurality of abrasive elements 104 carried by a balloon
170. The balloon 170 has a proximal end 171 coupled to a distal end
172 of a core tube 174. The core tube 174 also includes a proximal
end 176, an opening 177 at the proximal end 176, and a lumen 178
(not shown) extending between the distal end 172 and the proximal
end 176.
[0159] The proximal end 171 of the balloon 170 is preferably
detachably coupled to the distal end 172 of the core tube 174 by a
joint 180, such as an electrolytic joint or a mechanical joint, as
discussed previously with reference to FIGS. 16 and 17. This may
allow the balloon 170 to be de-coupled from the core tube 174 if
the balloon 170 cannot be retrieved during a procedure. The balloon
170 may also be secured to the distal end 172 of the core tube 174
by a glue or other suitable adhesive. Alternatively, the balloon
170 can be fabricated with the core tube 174 as one unit during
manufacturing. Optionally, the de-endothelialization device 100(3)
may include the core tube 174. The endothelialization device 100(3)
may also optionally include a tubular element 182, such as a sheath
or a catheter, that is capable of surrounding the core tube 174 and
the balloon 170 when it is un-inflated.
[0160] The balloon 170 is preferably made of thermoplastic or
elastomeric materials, such as polyimide (kapton), polyester,
silicone rubber, nylon, mylar, polyethylene, or polyvinyl chloride.
However, other elastic or inelastic materials known in the art may
also be used for constructing the balloon 170. Expandable balloons
have been described in U.S. Pat. No. 5,925,083, the entirety of
which is expressly incorporated by reference herein.
[0161] It should be noted that the shape of the expandable member
(i.e., the basket 150 or the balloon 170) is not necessarily
limited to those illustrated in the figures, and other shapes may
also be used. Furthermore, various patterns may be formed by the
abrasive element(s) 104 on the surface of the expandable member so
that only a desired portion of the endothelium of the aneurysm or
other body lumen is disrupted. FIG. 25B shows a balloon 170 wherein
only the distal end of the balloon 170 is covered by the abrasive
elements 104. Other patterns of the abrasive element(s) 104 may
also be used.
[0162] When using a de-endothelialization device 100 having an
expandable member (i.e., the basket 150 or the balloon 170), the
tubular element 182 is first positioned so that the distal end of
the tubular element 182 is adjacent to a neck of an aneurysm or at
the site of another body lumen to be de-endothelialized. The
tubular element 182 may be placed using a guide wire or other rail,
as is known in the art. The expandable member is initially
collapsed and placed within the lumen of the tubular element 182.
The expandable member may be inserted into a lumen 184 of the
tubular element 182 after the distal end of the tubular element 182
has been placed adjacent to the neck of the aneurysm or at the site
of another body lumen to be de-endothelialized. Alternatively, the
expandable member may be inserted into the lumen 184 of the tubular
element 182 first, and the tubular element 182 carrying the
expandable member may then be placed into a vessel leading to the
aneurysm or at the site of another body lumen to be
de-endothelialized.
[0163] The distal tip of the tubular element 182 is preferably
placed within the aneurysm or at the site of another body lumen to
be de-endothelialized. However, the distal tip of the tubular
element 182 may also be placed outside the aneurysm adjacent to the
neck of the aneurysm so long as the expandable member can be
deployed into the aneurysm, or placed adjacent to the segment of
vessel to be de-endothelialized so long as the expandable member
can be deployed into the segment of vessel to be
de-endothelialized. When the distal tip of the tubular element 182
is positioned as desired, the expandable member is then expanded.
For the de-endothelialization device 100 including the balloon 170,
the balloon 170 is expanded by delivering a fluid through the
opening 177 and into the lumen 178 of the core tube 174. The core
tube 174 delivers the fluid into an interior of the balloon 170,
thereby expanding the balloon 170. The fluid can be a gas or a
liquid, such as water, saline, or blood. A radio-opaque marker (not
shown) may be carried at the distal end of the tubular element 182
and/or the expandable member to help positioning the tubular
element 182 and/or the expandable member relative to the aneurysm
or other body lumen.
[0164] If the expandable member has an expanded shape that
substantially occupies an aneurysm or other body lumen, the
abrasive elements 104 may disrupt the endothelium of the aneurysm
or other body lumen when the expandable member is expanded. The
expandable member may also have an expanded shape that is slightly
larger than the aneurysm or other body lumen to enhance the
de-endothelialization property of the de-endothelialization device
100. After the endothelium of the aneurysm or other body lumen is
disrupted, the expandable member is then collapsed and removed from
the aneurysm or other body lumen.
[0165] Alternatively, before the expandable member is collapsed,
the expandable member may be moved within the aneurysm or other
body lumen by manipulating the handle 116, thereby causing further
disruption to the endothelium of the aneurysm or other body lumen.
After the abrasive element 104 of the de-endothelialization device
100 has disrupted a sufficient area of the endothelium of the
aneurysm or other body lumen, the de-endothelialization device 100
may then be withdrawn from the aneurysm or other body lumen.
II. De-Endothelialization Using Thermal Treatment
[0166] A. De-Endothelialization Using a Heated or Cooled
Implant
[0167] The endothelium of an aneurysm can also be disrupted by
altering the temperature of the endothelium. As mentioned
previously, the endothelium of an aneurysm or other body lumen can
be injured or destroyed at a temperature that is above 50.degree.
C. or below 0.degree. C. FIG. 26 shows an example of a
de-endothelialization device 200 adapted to be heated or cooled to
a de-endothelializing temperature. The de-endothelialization device
200 can be a variety of objects, such as a vaso-occlusive device,
so long as it is capable of reaching a temperature that is
sufficient for disrupting an endothelium of an aneurysm or other
body lumen. The de-endothelialization device 200 can be thermally
treated by placing it in a freezer or in an oven. Alternatively,
the de-endothelialization device 200 can also be thermally treated
by placing it in a media, such as water or saline, that has been
heated or cooled. Other methods known in the art for altering a
temperature of an object can also be used.
[0168] The de-endothelialization device 200 can have a variety of
shapes or forms. The de-endothelialization device 200 preferably
has a relaxed, secondary shape of a helical coil, as shown in FIG.
26. However, any of the shapes discussed previously with reference
to FIGS. 1-11 is also applicable to the de-endothelialization
device 200. In particular, the de-endothelialization device 200 can
have a tertiary shape. The de-endothelialization device 200 can
also include an expandable member, such as a balloon or a basket,
as discussed previously. Other shapes of devices capable of being
placed within a body cavity may also be used, as are known in the
art.
[0169] The de-endothelialization device 200 should be made from a
material that can maintain its structural integrity in a
de-endothelializing temperature. That is, the de-endothelialization
device 200 should be made from a material such that it will not
melt or become too brittle when subjected to the desired thermal
treatment. In general, because of their high thermal conductivity,
metals are preferable materials for constructing the
de-endothelialization device 200. Also, any of the materials
discussed previously with reference to the core member 12 of the
de-endothelialization device 10 can also be used, so long as the
de-endothelialization device 200 remains deliverable to an aneurysm
after thermal treatment. Other materials known in the art may also
be used for the constructing the de-endothelialization device
200.
[0170] FIG. 27 shows a de-endothelialization device 200(1) that is
adapted to be thermally treated before it is delivered to an
aneurysm or other body lumen. A tubular element 210, such as a
sheath or a catheter, is used to deliver the vaso-occlusive device
200(1) to an aneurysm or other body lumen. The tubular element 210
includes an insulative layer 212 at an interior surface of the
tubular element 210. The insulative layer 212 prevents or reduces
the amount of thermal transfer from the de-endothelialization
device 200(1) to an exterior surface 214 of the tubular element
210. The insulative layer 212 is preferably made of a polymer.
However, other materials having desired thermal insulation
properties known in the art may also be used. If the tubular
element 210 is made from a material that possesses desired thermal
insulation properties, then the insulative layer 212 becomes
optional, and is not required.
[0171] FIG. 27 shows that the de-endothelialization device 200 has
a secondary shape of a helical coil when disposed within the lumen
of the tubular element 210. However, as discussed previously, such
needs not to be the case. As shown in FIG. 28, the
de-endothelialization device 200(1) can also be stretched to a
substantially linear or curvilinear shape when disposed within the
lumen of the tubular element 210. The method of delivering the
de-endothelialization device 200(1) is similar to that discussed
previously with reference to FIGS. 12-15.
[0172] FIG. 29A shows a de-endothelialization device 200(2) that is
adapted to be heated after it has been placed within an aneurysm or
other body lumen. The de-endothelialization device 200(2) may
optionally include a tubular element 224, such as a sheath or a
catheter. The de-endothelialization device 200(2) is electrically
coupled to a core wire 220 that delivers electrical energy from a
source of electrical energy, such as a radio frequency (RF)
generator 222, to the device 200(2). The de-endothelialization
device 200(2) acts as a resistor and converts the electrical energy
to heat. Alternatively, as shown in FIG. 29B, the
de-endothelialization device 200(2) may be mechanically coupled to
a heatable element 223. The heatable element 223 may act as a
resistor and convert electrical energy from the generator 222 to
heat. Because of the mechanical coupling between the heatable
element 223 and the de-endothelialization device 200(2), heat flows
from the heatable element 223 to the de-endothelialization device
200(2) by conduction.
[0173] When using the de-endothelialization device 200(2), the
de-endothelialization device 200(2) is first placed within the
aneurysm or other body lumen by any conventionally known method.
For example, the tubular element 224 may first be inserted into a
vasculature of a patient such that the distal end of the tubular
element 224 is adjacent to an aneurysm or other body lumen. The
de-endothelialization device 200(2) can then be delivered to the
aneurysm or other body lumen via the tubular element 224.
[0174] Once positioned within the aneurysm or other body lumen, the
de-endothelialization device 200(2) is then heated. When the
temperature of the de-endothelialization device 200(2) reaches a
desired level, the de-endothelialization device 200(2) can then be
de-coupled from the core wire 220 by methods that are described
previously. The tubular element 224 and/or the core wire 220 may
optionally include a sensor, such as a thermistor, to monitor the
temperature at the distal end of the core wire 220.
[0175] Although the de-endothelialization device 200(2) is adapted
to be deployed within a body cavity as an implant, such needs not
be the case. After the endothelium of the aneurysm or other body
lumen has been sufficiently disrupted by the heated
de-endothelialization device 200(2), the de-endothelialization
device 200(2) can be removed from the aneurysm or other body lumen
by retracting a proximal end of the core wire 220, thereby causing
the de-endothelialization device 200(2) to retract back into the
lumen of a tubular element 224. As such, the de-endothelialization
device 200(2) may also be used as a tool without being implanted in
a body cavity. One or more vaso-occlusive devices may then be
delivered to fill the aneurysm or other body lumen. If the aneurysm
or other body lumen is small, the de-endothelialization of the
aneurysm may cause the wall to be thicken enough to occlude the
aneurysm without using a vaso-occlusive device.
[0176] B. De-Endothelialization Using a Heat Delivery Device
[0177] FIG. 30 shows a de-endothelialization device 300 that is
adapted to deliver heat energy to an endothelium of an aneurysm.
The de-endothelialization device 300 includes an operative element
302 and an elongate member 304 having a distal end 306 and a
proximal end 308. The operative element 302 is carried at the
distal end 306 of the elongate member 304, and is adapted to be
electrically coupled to a generator 310. Optionally, the
de-endothelialization device 300 may include a sheath 312 having a
lumen 314 within which the distal end 306 of the member 304 may
slide. Optionally, the de-endothelialization device 300 may also
include a steering mechanism, such as that shown in FIGS. 21A and
21B and described above, to facilitate positioning the operative
element 302.
[0178] The operative element 302 may have a variety of shapes. In
general, any of the shapes discussed previously with reference to
the de-endothelialization devices 10 shown in FIGS. 1-11 may be
used for the operative element 302. The operative element 302 may
also include an expandable basket such as that shown in FIGS.
22-24, in which case each of the wires 152 (or the elements making
up the basket) may be selectively heated. Alternatively, the
operative element 302 may include a balloon, such as that shown in
FIG. 25A, in which case the balloon may be heated by supplying
and/or circulating heated fluid within the balloon. Cooled fluid
may also be used if it is desirable to disrupt the endothelium of
an aneurysm or other body lumen using balloon that is below a
certain temperature.
[0179] When using the de-endothelialization device 300, the
operative element 302 is first inserted into a vein or an artery
and positioned within an aneurysm or other body lumen. The sheath
312 and/or a guide wire may be used to facilitate positioning the
operative element 302, as is known in the art. The
de-endothelialization device 300 may optionally include a
radio-opaque marker on a distal portion of the member 304 and/or
the sheath 312, so that the position of the device can be monitored
during the procedure. The operative element 302 may receive
electrical energy from the generator 310, and convert the
electrical energy generated by the generator 310 to heat.
[0180] The operative element 302 may be used to deliver heat to the
endothelium of an aneurysm or other body lumen by convection or
conduction. Delivering heat to the endothelium by convection does
not require the operative element 302 to directly contact the
endothelium of the aneurysm or other body lumen. Rather, heat is
transferred from the operative element 302 to the endothelium by
the medium, such as blood, that is between the operative element
302 and the endothelium. On the other hand, delivering heat to the
endothelium by conduction may require the operative element 302 to
contact the endothelium of the aneurysm or other body lumen. In
either case, the amount of heat generated by the operative element
302 should be sufficient such that the endothelium of the aneurysm
or other body lumen is disrupted. The distal end of the elongate
member 304 may optionally include a sensor, such as a thermistor,
to detect a temperature of the operative element 302. After the
de-endothelialization process, the operative element 302 of the
de-endothelialization device 300 is then removed from the aneurysm
or other body lumen.
[0181] C. De-Endothelialization Using a Heat Producing or Cooling
Chemical
[0182] The endothelium of an aneurysm or other body lumen may also
be disrupted by a heat producing chemical. For example, a dual
lumen catheter may be used to deliver two fluids, such as calcium
chloride and water, that, when mixed, undergo a chemical reaction
that produces heat. Alternatively, fluids such as ammonium nitrate
and water, known to cause a cooling reaction when mixed may also be
used. U.S. patent application Ser. No. 10/150,456, the disclosure
of which is expressly incorporated by reference herein, describes a
dual lumen catheter that may be suitable for delivering the two
heat producing fluids. Other commercially available dual lumen
catheters may also be used. Alternatively, a single lumen catheter
may be used to deliver the two fluids, sequentially or alternately,
to an aneurysm or other body lumen.
III. De-Endothelialization Using a Fluid
[0183] A. Delivery of De-Endothelialization Fluid Using a Fluid
Delivery Device
[0184] The endothelium of an aneurysm or other body lumen may also
be disrupted using a fluid 350 that is delivered to the endothelium
of the aneurysm. As used herein, "fluid" refers to both liquid and
gas. The fluid 350 may be a heated or cooled liquid, such as water
or saline. The fluid 350 may also contain any cytotoxic agent
including, but not limited to oxidized LDL, perforins,
toxin-conjugated antibodies to the endothelial cells, antibodies to
the complement protective proteins decay accelerating factor (DAF)
(also known as CD55), homologous restriction factor (also known as
CD59), membrane cofactor protein (MCP) (also known as CD46),
mitochondrial inhibitors, inhibitors of cell membrane ion-pumps,
hypotonic fluid, hypertonic solution, CD4 T cells, and/or agents
that induce apoptosis/Fas receptor agonists. Enzymes, such as
trypsin or collagenase, that are capable of chemically removing the
endothelial cells from its basement membranes can also be used. The
fluid 350 can also be other drugs, medications, solutions, that are
known in the art for disrupting cells or tissues.
[0185] FIG. 31 shows a de-endothelialization fluid delivery device
360(1) that includes a delivery tube 362 having a distal end 364, a
proximal end 366, and a lumen 368 extending between the distal end
364 and the proximal end 366. The delivery tube 362 may be a
catheter, micro catheter, or sheath capable of being inserted into
a vasculature of a mammal. The distal end 364 of the delivery tube
362 is adapted to be placed adjacent or within an aneurysm or other
body lumen, while the proximal end 366 of the delivery tube 362 is
adapted to be coupled to a fluid source 370. The
de-endothelialization fluid delivery device 360 may optionally
include the fluid source 370. The fluid source 370, which includes
a container such as a syringe, a bag, a bottle, or any
fluid-holding device, contains the fluid 350 that is capable of
disrupting an endothelium of an aneurysm or other body lumen, as
discussed previously.
[0186] When using the de-endothelialization fluid delivery device
360, the distal end 364 of the delivery tube 362 is first placed
within the aneurysm or other body lumen. The distal end of the
delivery tube 362 may optionally include a radio-opaque marker to
assist positioning the delivery tube 362. When the delivery tube
362 is positioned as desired, the fluid 350 is then delivered from
the fluid source 370 to within the aneurysm or other body lumen.
Optionally, the fluid source 370 may include a pump or syringe for
pressurizing the fluid 350 during the procedure. After the fluid
350 contacts the endothelium of the aneurysm or other body lumen,
the de-endothelialization property of the fluid 350 causes the
endothelium of the aneurysm or other body lumen to be disrupted.
When a desired amount of the fluid 350 has been delivered, the
distal end 364 of the delivery tube 362 is then withdrawn from the
aneurysm or other body lumen.
[0187] In certain situations, it may be desirable to prevent the
fluid 350 from leaving the aneurysm or other body lumen once the
fluid 350 has been delivered into the aneurysm or other body lumen.
FIG. 32 shows a de-endothelialization fluid delivery device 360(2)
wherein the distal end 364 of the delivery tube 362 has a diameter
380 that is substantially the same or slightly larger than a
diameter of an aneurysm or other body lumen. In this case, after
the fluid 350 has been delivered to the aneurysm, most or all of
the excess fluid 350 may flow back into the lumen 368 of the
delivery tube 362. Optionally, a source of vacuum (not shown) may
be coupled to the lumen 368 to aspirate fluid from the aneurysm or
other body lumen.
[0188] FIG. 33A shows another de-endothelialization fluid delivery
device 360(3) that includes one or more drainage ports 390 at the
distal end 364 of the delivery tube 362. The delivery tube 362
further includes a drainage lumen 392 that is in fluid
communication with the drainage port(s) 390. The
de-endothelialization fluid delivery device 360(3) also has a
distal end diameter 380 that is substantially the same or slightly
larger than a diameter of an aneurysm. The drainage ports 390 are
located proximal to the distal tip of the delivery tube 362. FIG.
33B shows a variation of the construction of the delivery tube 362
in which the drainage port 390 is also proximal to the distal tip
of the delivery tube 362.
[0189] When using the de-endothelialization device 360(3), the
distal end 364 of the delivery tube 362 is inserted into an
aneurysm such that the drainage port(s) 390 is in fluid
communication with an interior of the aneurysm. After the fluid 350
has been delivered to the aneurysm through the lumen 368 of the
delivery tube 362, most or all of the excess fluid 350 may flow
back into the drainage lumen 392 of the delivery tube 362 through
the drainage port(s) 390.
[0190] FIG. 33A shows that the drainage port 390 is located
transversely at a wall of the delivery tube 362. However, the
drainage port 390 may also be located elsewhere. As shown in FIG.
33C, the drainage port 390 may also be located at the distal tip of
the delivery tube 362. It should be noted that the number of
drainage ports 390 may vary. Furthermore, the usage of the lumen
368 of the delivery tube 362 and the lumen 392 may interchange. In
an alternative embodiment, the lumen 392 may be used to delivery
fluid 350 to an aneurysm, and the lumen 368 of the delivery tube
362 may be used to drain or aspirate fluid 350 from the
aneurysm.
[0191] The previously illustrated embodiments show that the
drainage lumen 368 is defined within the wall of the delivery tube
362. Alternatively, as shown in FIG. 33D, the delivery tube 362 may
include an inner tube 394 placed coaxially within the lumen 368 of
the delivery tube 362. The inner tube 394 has a lumen 396 that is
in fluid communication with one or more drainage ports 390 located
at the distal end 364 of the delivery tube 362. Excess fluid 350
from the aneurysm may be drained into the drainage port 390 and
delivered to a proximal end via the lumen 396 of the inner tube
394. Alternatively, the inner tube 394 may be used to deliver fluid
350 to the aneurysm and the lumen 368 of the delivery tube 362 may
be used to aspirate excess fluid 350 from the aneurysm to a
proximal end of the tube 362.
[0192] FIG. 34A shows another de-endothelialization fluid delivery
device 360(4) that includes the delivery tube 362 and a sealing
member or stopper 400 secured to the distal end 364 of the delivery
tube 362. The device 360(4) may include one or more drainage ports
(not shown) in accordance with any of the embodiments described
above. The stopper 400 is used to substantially seal the aneurysm,
i.e., to prevent or reduce the risk of having fluid 350 delivered
into the aneurysm from escaping into the artery or vein 402. As
such, the diameter 380 of the delivery tube 362 may be
substantially the same or smaller than a diameter of the aneurysm,
as discussed previously with reference to FIG. 32. If the delivery
tube 362 has a diameter that is substantially the same or slightly
larger than a diameter of an aneurysm, then the stopper 400 may
function as a back-up device for preventing excess fluid 350 from
flowing into the artery or vein 402. The stopper 400 is preferably
made of a compressible or collapsible material, such as rubber or a
foam-like material. However, other materials may also be used. The
stopper 400 should have a shape and dimension such that it may
substantially engage tissue around the neck of the aneurysm to
substantially seal the aneurysm and prevent substantial leakage of
fluid 350 into the artery or vein 402.
[0193] The de-endothelialization fluid delivery device 360(4) may
optionally include a sheath 404 having a lumen 406. As shown in
FIG. 34B, the sheath 404 is capable of surrounding the distal end
364 of the delivery tube 362 such that the stopper 400 assumes a
folded configuration when disposed within the lumen 406 of the
sheath 404. Depending on the geometry of the stopper 400, the
stopper 400 may also assume a compressed configuration when
disposed within the lumen 406 of the sheath 404 (FIGS. 34C and
34D).
[0194] When using the de-endothelialization fluid delivery device
360(4), the sheath 404 is first inserted into an artery or vein and
advanced until the distal end of the sheath 404 is adjacent an
aneurysm. The sheath 404 may be advanced over a guide wire or other
rail, as is known in the art. The delivery tube 362 may be placed
initially within the lumen 406 of the sheath 404 and the sheath 404
together with the delivery tube 362 may then be positioned adjacent
the aneurysm. Alternatively, the delivery tube 362 may be inserted
into the lumen 406 of the sheath 404 after the sheath 404 is
desirably placed. The stopper 400 may assume a bent and/or
compressed configuration when disposed within the lumen 406 of the
sheath 404.
[0195] The stopper 400 may be deployed, e.g., by retracting the
sheath 404 relative to the tubular element 362, or by advancing the
delivery tube 362 relative to the sheath 404. As shown in FIG. 34A,
the stopper 400 may be deployed directly outside the neck of the
aneurysm such that a distal side 412 of the stopper 400 engages
with a vessel wall 413 directly outside the aneurysm so that the
neck of the aneurysm is substantially sealed by the stopper 400.
Alternatively, as shown in FIG. 34E, the stopper 400 can be
deployed inside the neck of the aneurysm such that the proximal
side 410 of the stopper 400 engages with the endothelium of the
aneurysm.
[0196] The fluid 350 is then delivered to the aneurysm from the
fluid supply 310. After the fluid 350 contacts the endothelium of
the aneurysm, the de-endothelialization property of the fluid 350
causes the endothelium of the aneurysm to be disrupted. The neck of
the aneurysm is substantially sealed by the stopper 400 during the
process such that fluid 350 may be drained or aspirated via a
drainage port 390 without substantial leaking from the aneurysm
into the artery or vein 402. After a desired amount of the fluid
350 has been delivered and/or aspirated, the delivery tube 362 and
the stopper 400 are then withdrawn back into the lumen 406 of the
sheath 404.
[0197] The shape of the stopper 400 should not be limited to the
examples shown previously and that the stopper 400 may have other
shapes. FIG. 34F shows a de-endothelialization fluid delivery
device 360(5) that includes a stopper 400 having an elliptical
shape. When using the de-endothelialization fluid delivery device
360(5), a portion of the stopper 400 may be inserted into the
aneurysm until the stopper 400 bears against a surface 410 that
defines the neck of the aneurysm. If desired, the distal end 364 of
the delivery tube 362 may be advanced a relatively small increment
to compress the stopper 400 within the neck of the aneurysm. This
has the benefit of ensuring that the neck of the aneurysm is
substantially sealed by the stopper 400. The fluid 350 is then
delivered into the aneurysm, as discussed previously. Fluid 350
delivered to the aneurysm may be aspirated or otherwise drained
into a drainage port (now shown), the stopper 400 substantially
preventing the fluid 350 from leaking from the aneurysm, as
discussed previously.
[0198] FIG. 35 shows a de-endothelialization fluid delivery device
414 in accordance with another embodiment of the present invention.
The de-endothelialization fluid delivery device 414 includes an
outer tubular element 415 and an inner tubular element 416 slidable
within a lumen of the outer tubular element 415. The outer tubular
element 415, which is preferably a micro-catheter or a sheath, may
have a diameter that is the same or slightly larger than the neck
of an aneurysm, as discussed previously with reference to FIG. 32.
The proximal end of the inner tubular element 416 may be coupled to
a source of de-endothelialization fluid (not shown).
[0199] When using the de-endothelialization fluid delivery device
414, the distal tip of the outer tubular element 415 is first
placed within the neck of an aneurysm or other body lumen, as shown
in FIG. 35. The outer tubular element 415 may be placed and/or
positioned using similar methods to those discussed previously,
e.g., with reference to FIG. 32, or by conventionally known
techniques. The inner tubular element 416 may be disposed within
the lumen of the outer tubular element 415 and delivered together
with the outer tubular element 415 to a target site. Alternatively,
the inner tubular element 416 may be inserted into the lumen of the
outer tubular element 415 after the outer tubular element 415 is
desirably situated, and then advanced distally until it reaches the
distal end of the outer tubular element 415. Either or both of the
outer and inner tubular elements may include one or more
radio-opaque markers (not shown) at their respective distal ends
for facilitating positioning the tubular elements.
[0200] When both the outer and inner tubular elements 415 and 416
are desirable positioned, de-endothelialization fluid is then
delivered into the aneurysm or other body lumen via the inner
tubular element 416. Depending upon the size and geometry of the
aneurysm or other body lumen, the inner tubular element 416 may be
advanced and/or retracted relative to the outer tubular element 415
at various positions during and/or before delivering the
de-endothelialization fluid. Excess de-endothelialization fluid may
be aspirated or drained by the outer tubular element 415 during
and/or after the delivery of the de-endothelialization fluid. After
a desired amount of de-endothelialization has been delivered, the
outer and inner tubular elements 415 and 416 are then withdrawn
from the target site.
[0201] The de-endothelialization fluid delivery device 414 may
further include a coil 417 secured to the distal end of the inner
tubular element 416, such as that shown in FIG. 36, to disperse the
injected fluid within the aneurysm or other body lumen. The coil
417 is not limited to the linear shape shown in the illustrated
embodiment, and may have other shapes as well. In particular, the
coil 417 may have any of the secondary shapes discussed previously
with reference to FIGS. 5-11. The coil 417 is preferably made from
a radio-opaque material, such as platinum. However, other materials
such as stainless steel, aluminum, and/or plastic, may also be
suitable for constructing the coil 417. Generally, any of the
materials discussed previously with reference to the core member 12
may also be used. The length of the coil 417 is preferably from
about two millimeters (2 mm) to about three hundred millimeters
(300 mm). The coil 417 may also have other lengths, depending on
the particular application. The spacing between the windings of the
coil 417 may vary. Generally, smaller spacing between the windings
may better disperse the de-endothelialization fluid.
[0202] In the illustrated embodiment, the coil 417 is secured to
the distal end of the inner tubular element 416 by an epoxy 418.
Other suitable adhesives may also be used. As shown in FIG. 36, the
proximal end of the coil 417 fits around the distal end of the
inner tubular element 416. Alternatively, the proximal tip of the
coil 417 may abut and be secured to the distal tip of the inner
tubular element 416, as shown in FIG. 37. The de-endothelialization
fluid delivery device 414 may further include an atraumatic tip 419
secured to the distal end of the coil 417.
[0203] When using the de-endothelialization fluid delivery device
414 of FIG. 36 in an aneurysm, the distal end of the outer tubular
element 415 is first placed within the neck of then aneurysm, as
discussed previously, e.g., with reference to FIG. 35. The inner
tubular element 416 is then advanced within the lumen of the outer
tubular element 415 until the coil 417 extends at least partially
beyond the distal end of the outer tubular element 415 and into the
aneurysm. If the coil 417 has a secondary shape or configuration,
it may attempt to return towards the secondary shape as it is
deployed from the lumen of the outer tubular element 415.
De-endothelialization fluid may then be delivered via the inner
tubular element 416 into the lumen of the coil 417, where it may
escape through spaces between the windings of the coil 417. The
windings of the coil 417 may disperse the de-endothelialization
fluid within the aneurysm. De-endothelialization fluid may then be
aspirated or drained by the outer tubular element 415. When a
desired amount of the de-endothelialization fluid has been
delivered and/or aspirated, the outer and inner tubular elements
415 and 416 may then be withdrawn from the treatment site.
[0204] It should be understood by those skilled in the art that the
outer tubular element 415 discussed previously with reference to
FIGS. 35-37 is primarily used to aspirate excess delivered
de-endothelialization fluid, and that, optionally, it may be
eliminated (or if provided, it may not necessarily be placed within
the neck of the aneurysm) if the de-endothelialization fluid may be
mixed safely with blood. In this case, the de-endothelialization
fluid may leak out of the sac of the aneurysm without being
aspirated or drained by the outer tubular element 415.
[0205] FIG. 38A shows a de-endothelialization fluid delivery device
420 that includes a balloon 422 having a lumen 424 (shown in FIG.
38B), a delivery tube 426, and a sheath 428. The sheath 428
preferably has a diameter or cross-sectional dimension that is the
same or slightly larger than that of a neck of an aneurysm so that
it can be used to aspirate de-endothelialization fluid from the
aneurysm, as discussed previously with reference to the outer
tubular element 415 in FIGS. 35-37. The balloon 422 is preferably
made of a compliant material, such as silicone, rubber, low density
polyethylene, high density polyethylene, polypropylene, polybutene,
interpolymers or mixtures of these polymers, so that when it is
inflated, it may conform to the shape of an aneurysm. In general,
any of the materials discussed previously with reference to the
balloon 170 of FIG. 25A is also applicable for constructing the
balloon 422. The balloon 422 is not limited to the shape shown in
the illustrated embodiment, and may have other shapes as well.
[0206] The delivery tube 426 includes a distal end 430, a proximal
end 432 (not shown), and a lumen 434 (FIG. 38B) extending between
the distal end 430 and the proximal end 432. The distal end 430 of
the delivery tube 426 is coupled to the balloon 422 such that the
lumen 424 of the balloon 422 communicates with the lumen 434 of the
delivery tube 426. The balloon 422 includes one or more openings
436 that communicate with the lumen 424 of the balloon 422. The
opening 436 has a size such that, when the balloon 422 is inflated
by fluid, the opening 436 may expand sufficiently to allow fluid to
exit the balloon 422.
[0207] As shown in FIG. 39A, the de-endothelialization device 420
may further include one or more drainage ports 440 located at a
surface of the balloon 422, through which fluid 350 may be
aspirated and delivered back to a proximal end (not shown) of the
delivery tube 426 via a drainage lumen 442. FIG. 39B is a cross
sectional view of the delivery tube 426, showing the drainage lumen
442 inside a wall of the delivery tube 426. FIGS. 40A and 40B show
a variation of the de-endothelialization fluid delivery device 420
in which the drainage lumen 442 is a separate drainage tube 448
surrounded by the delivery tube 428. It should be noted that the
location and number of drainage ports 440 and the shape of the
balloon may vary, and that they should not be limited to the
examples shown in the illustrated embodiments.
[0208] FIG. 41 shows another variation of the de-endothelialization
fluid delivery device 420 that includes a sealing member or stopper
450 secured to the balloon 422. Although the illustrated embodiment
shows that the stopper 450 extends above the surface of the balloon
422, the stopper 450 may also be constructed such that it is flush
with the surface of the balloon 422. The stopper 450 may have a
variety of shapes, and is not limited to the planar configuration
shown in the illustrated embodiment. Furthermore, the stopper 450
may be secured to the distal end of the delivery tube 428 (not
shown, see FIG. 38A) instead of to the balloon 422 so long as the
stopper 450 is capable of sealing the neck of the aneurysm to
prevent fluid 350 from leaving the aneurysm. In general, any of the
materials discussed previously with reference to the stopper 400
may be used for the stopper 450.
[0209] When using the de-endothelialization fluid delivery device
420, the balloon 422 is inflated within the aneurysm by delivering
fluid 350 via the delivery tube 426 into the lumen 424 of the
balloon 422. When the balloon 422 is inflated to a certain size,
the fluid 350 exits through the opening(s) 436 of the balloon 422
due to internal pressure within the balloon 422 and/or the size of
the opening(s) 436 increasing as the balloon 422 expands. The fluid
350 then contacts the endothelium of the aneurysm, thereby
disrupting the endothelium. If the de-endothelialization fluid
delivery device 420 includes a drainage port 440, it may be used to
aspirate fluid 350 from within the aneurysm. Alternatively, if the
de-endothelialization fluid delivery device 420 includes a stopper
450, the stopper 450 may be used to absorb fluid 350 within the
aneurysm. When the de-endothelialization process is complete, the
balloon 422 may be deflated and removed from the aneurysm.
[0210] FIG. 42A shows another variation of the
de-endothelialization fluid delivery device 420 that includes a
separate delivery lumen 460 for delivering fluid to an aneurysm. In
this case, the delivery tube 426 (not shown, see FIG. 38A) may be
used to deliver an inflation fluid, such as water, saline, blood,
and/or de-endothelialization fluid 350 to the lumen 424 of the
balloon 422 to inflate the balloon 422. After the balloon 422 has
been inflated to a desired size, the de-endothelialization fluid
may be delivered via the delivery lumen 460 to the aneurysm. FIG.
42A shows that the delivery lumen 460 is formed within a wall of
the delivery tube 428. Alternatively, as shown in FIG. 42B, a
separate tube 462 may provide the delivery lumen 460. The tube 462
is coaxially surrounded by the delivery tube 428. In either case,
the de-endothelialization device 420 may optionally include a
drainage port 440 or a stopper 450 as discussed previously.
[0211] Optionally, any of the de-endothelialization fluid delivery
devices described previously with reference to FIGS. 31-42B may be
used with a perfusion balloon 600, such as that shown in FIG. 43A.
The perfusion balloon 600 has a lumen 602, and is coupled to an
inflation tube 604 such that the lumen 602 of the perfusion balloon
600 is in fluid communication with a lumen of the inflation tube
604. The perfusion balloon 600 has a shape such that when it is
inflated, it defines an opening 608 for allowing blood to flow
through the perfusion balloon 600. The perfusion balloon 600 is
preferably made of an elastic material, such as a polymer. In
general, any of the materials discussed previously with reference
to the balloon 170 of FIG. 25A may also be used. However, other
materials may also be used.
[0212] Before using the perfusion balloon 600, a
de-endothelialization fluid delivery device 609 is first placed
adjacent or within an aneurysm. The de-endothelialization fluid
delivery device 609 is representative of any of the
de-endothelialization fluid delivery devices described previously
with reference to FIGS. 31-42B. When using the perfusion balloon
600, the perfusion balloon 600 is delivered to a site where the
aneurysm is located. A sheath 610 may be used to deliver the
perfusion balloon 600. If the de-endothelialization device 609
includes a sheath, the sheath of the de-endothelialization device
may also be used instead to deliver the perfusion balloon 600. The
perfusion balloon 600 is collapsed and assumes a low profile when
disposed within the lumen of the sheath.
[0213] Once the sheath 610 is adjacent the aneurysm, the perfusion
balloon 600 is deployed from the distal end of the sheath, either
by distally advancing the perfusion balloon 600 relative to the
distal end of the sheath 610, or by retracting the sheath 610
relative to the perfusion balloon 600. An inflation fluid, such as
saline, water, blood, or gas is then delivered by the inflation
tube 604 to within the lumen 602 of the perfusion balloon 600,
thereby expanding the perfusion balloon 600 until a surface 612 of
the perfusion balloon 600 engages the vessel wall 614. As shown in
FIG. 43A, when the perfusion balloon 600 is inflated, it forms a
barrier substantially sealing the neck of the aneurysm, thereby
reducing the chance that fluid 350 delivered into the aneurysm may
escape into the vessel or artery.
[0214] FIG. 43B shows a variation of the perfusion balloon 600 that
includes a slot 620 in which a portion of the de-endothelialization
fluid delivery device 609 may be placed. The slot 620 preferably
has a depth 622 that is substantially the same as a diameter of the
de-endothelialization fluid delivery device 609. This may allow the
de-endothelialization fluid delivery device 609 to form a
substantially continuous surface with the perfusion balloon 600 to
better engage the wall 614 of the vessel or artery, as shown in
FIG. 43C.
[0215] FIG. 44A shows a de-endothelialization fluid delivery device
640 that includes a balloon 642 and a triple-lumen catheter 644.
The balloon 642 is coupled to a distal portion 646 of the
triple-lumen catheter 644. As shown in FIG. 44B, the triple-lumen
catheter 644 includes a first lumen 648 that communicates with a
lumen 650 of the balloon 642, a second lumen 652 for delivering
de-endothelialization fluid 350 to an aneurysm, and a third lumen
654 for aspirating fluid 350 from the aneurysm. It should be noted
that the association of specific lumens with respective purposes is
merely a matter of design choice, and that any of the lumens 648,
652, and 654 may be used for inflating the balloon 642, delivering
fluid 350, and draining fluid. The balloon 642 includes one or more
openings 658 communicating with the second lumen 652 of the
triple-lumen catheter 644, and one or more drainage ports 660
communicating with the third lumen 654 of the triple-lumen catheter
644. The balloon 642 preferably has a tubular shape, e.g., similar
to the perfusion balloon 600 discussed previously, such that blood
may continue to flow through the vein or artery while the fluid 350
is being delivered to the aneurysm. The de-endothelialization fluid
delivery device 640 may further include a sheath 661.
[0216] The triple-lumen catheter 644 is not necessarily limited to
the configuration described previously. FIG. 44C shows a variation
of the triple-lumen catheter 644 that includes a first tube 662
defining the first lumen 648, a second tube 664 defining a second
lumen 652, and a third tube 666 defining a third lumen 654. The
first tube 662 coaxially surrounds the second tube 664 and the
third tube 666. FIG. 44D shows another variation of the
triple-lumen catheter 644 in which the first tube 662 surrounds the
second tube 664, and the second tube 664, in turn, surrounds the
third tube 666.
[0217] When using the de-endothelialization fluid delivery device
640, the balloon 642 is first placed adjacent to a neck of the
aneurysm. The balloon 642 may be delivered using a sheath 661
and/or a guide wire, as is known in the art. For example, the
sheath 661 may be advanced over a guide wire (not shown) through a
vasculature until the distal end of the sheath 661 is adjacent to
the neck of the aneurysm. The balloon 642 coupled to the
triple-lumen catheter 644 may then be deployed from the lumen of
the sheath 661, e.g., by advancing the balloon 642 into the lumen
from the proximal end of the sheath 661 until it emerges at the
distal end of the sheath 661.
[0218] Before and/or after the balloon 642 exits the lumen of the
sheath 661, if required, the position and/or the orientation of the
balloon may be adjusted by advancing, retracting, and/or rotating
the proximal end of the triple-lumen catheter 644, until the
openings 658 and 660 of the balloon 642 face the opening of the
aneurysm. The balloon 642 is then inflated by a media, such as
saline, a gas, or other fluid. The balloon 642 substantially closes
the neck opening of the aneurysm while allowing blood to flow
through the vein or artery. Next, de-endothelialization fluid 350
may be delivered through the second lumen 652 of the triple-lumen
catheter 644 into the aneurysm. If the de-endothelialization fluid
delivery device 640 includes a drainage port 660, fluid 350 may be
aspirated from the aneurysm via then port 660. After a desired
amount of the fluid 350 has been delivered, the balloon 642 is then
deflated and withdrawn into the lumen of the sheath 661.
[0219] FIG. 45 shows another de-endothelialization fluid delivery
device 690 that includes an applicator 692, a tube 694, and a
sheath 695. The applicator is coupled to a distal end 696 of the
tube 694, and is capable of being compressed into a low profile
when disposed within the lumen of the sheath 695 (FIG. 46). The
applicator 692 is made of a porous and/or absorptive material,
e.g., similar to a sponge. The tube 694 also has a proximal end 698
that is coupled to the fluid source 370. When using the
de-endothelialization device 690, the applicator 692 is first
deployed into an aneurysm. De-endothelialization fluid 350 is then
delivered via the tube 694 to the applicator 692. Alternatively,
the applicator 692 may also be deployed into the aneurysm after the
fluid 350 is delivered to the applicator 692. The applicator 692
controls the amount of fluid 350 that may be delivered to the
aneurysm, thereby reducing the risk of having excess fluid 350
flowing from the aneurysm to an artery or vessel. It should be
noted that applicator 692 may have other shapes and/or that other
types of applicators known in the art may also be used.
[0220] Turning to FIGS. 52A-52E, a system 810 is shown for treating
an aneurysm 90 extending from a body lumen, such as a cerebral
artery or other blood vessel 92. Generally, the system 810 includes
an outer tubular member 812 including a proximal end (not shown), a
distal end 814 having a size and shape for insertion into the
aneurysm 90, and a lumen 816 extending between the proximal end and
distal end 814. The system 10 also includes an inner tubular member
822 disposed within the outer tubular member 812 that also includes
a lumen 826. The inner tubular member 822 may be slidable relative
to the outer tubular member 812, e.g., to retract or expose a
distal end 824 of the inner tubular member 822, as will be
appreciated by those skilled in the art.
[0221] The inner tubular member 822 is substantially smaller than
the outer tubular member 812 such that the lumen 816 between the
inner and outer tubular members 822, 812 has a generally annular
cross-section. The lumen 826 within the inner tubular member 822
may be coupled to a source of fluid (not shown), thereby providing
an infusion lumen, while the annular lumen 816 may be coupled to a
source of vacuum (also not shown), thereby providing an aspiration
lumen. Alternatively, the functions of these lumens 816, 826 may be
reversed or they may coupled to other components, as will be
appreciated by those skilled in the art.
[0222] Turning to FIG. 53, a dual syringe apparatus 850 is shown
that may be coupled to the inner and/or outer tubular members 822,
812 shown in FIGS. 52A-52E, e.g., by tubing 818, 828. Generally,
the apparatus 850 includes first and second syringe barrels 852,
862 including first and second chambers 854, 864 and first and
second pistons 856, 866, respectively. The barrels 852, 862 may
have similar cross-sections or different cross-sections, depending
upon whether the delivery and aspiration should be the same or
different from one another. The first and second pistons 856, 866
are movable within the first and second chambers, respectively, for
delivering fluid and/or for aspirating fluid, as explained further
below. In addition, the first barrel 852 includes an outlet port
858 and the second barrel 862 has an inlet port 868 to which tubing
828, 818 may be connected using conventional methods, e.g., luer
lock connectors and the like (not shown).
[0223] The system 850 also includes an actuator 870 for moving the
first piston 856, e.g., to deliver fluid within the first chamber
854, and/or for moving the second piston 866, e.g., to aspirate
fluid into the second chamber 864. In the preferred embodiment
shown, the actuator 870 includes a motor 872 with an output shaft
874 that is coupled to shafts 876, 886, e.g., via sprockets or
wheels 878, 888. Preferably, the wheels 878, 888 are coupled to one
another such that, when the motor 872 is operated, the output shaft
874 simultaneously rotates the wheels 878, 888, thereby
simultaneously advancing and retracting the pistons 856, 866,
respectively. It will be appreciated that other actuators may also
be provided that may be operated manually and/or automatically,
instead of the motor and shaft arrangement shown in FIG. 53. In
addition, the volumetric rates of fluid delivery and fluid
aspiration need not be the same.
[0224] It will be appreciated that other fluid moving elements may
be provided in addition to or instead of the dual syringes
described above. For example a fluid delivery pump and as
aspiration pump may be coupled to the delivery and aspiration
lumens and to an actuator for simultaneously delivering and
aspirating fluid, as described elsewhere herein.
[0225] Returning to FIGS. 52A-52E, optionally, the system 810 may
include an occlusion member 830 for substantially sealing the
aneurysm 90 from the vessel 92. In the embodiment shown, the
occlusion member 830 includes an expandable member 832 carried on a
distal end 834 of an elongate member 836. In a preferred
embodiment, the expandable member 832 is a compliant, nonporous
balloon and the elongate member 836 is a catheter or micro-catheter
including an inflation lumen for infusing fluid into and/or
aspirating fluid from the balloon. Alternatively, a mechanically
expandable member (not shown) or other sealing member may be
provided. In a further alternative, an expandable member (not
shown) may be provided proximate to the distal end of the outer
tubular member 812, rather than on a separate member.
[0226] In other alternatives, similar to the embodiment described
above, the inner member may be eliminated, and the outer tubular
member may include two lumens, one for infusion and one for
aspiration (not shown). The lumens may be arranged coaxially,
side-by-side, or in any other configuration. The distal end of the
outer tubular member may include one or more ports spaced apart
from one another in a desired arrangement, with one or more ports
communicating with respective lumens.
[0227] In yet another alternative, the expandable member may
include one or more ports, and the elongate member may include one
or more additional lumens communicating with respective ports,
e.g., for infusing or aspirating fluid, similar to the embodiments
described above with reference to FIG. 44A. This may allow the
inner tubular member to be eliminated, while only requiring the
outer tubular member to include one lumen, or may even allow both
tubular members to be eliminated.
[0228] Returning to FIGS. 52A-52E, a method is shown for treating a
malformation, such as an aneurysm 90, extending from a body lumen,
such as a blood vessel 92. Initially, the outer tubular member 812
may be introduced into the patient's vasculature, e.g., from a
percutaneous entry site, and advanced over a guidewire (not shown)
until the distal end 814 is located within the aneurysm 90. The
outer tubular member 812 may include a substantially rounded and/or
atraumatic tip to facilitate advancing the outer tubular member 812
through tortuous anatomy, as is well known in the art.
[0229] The occlusion member 830 may be advanced into the vessel 92
until the expandable member 832 is disposed adjacent the aneurysm
90. The occlusion member 830 may be delivered within a catheter,
sheath, or other device, e.g., to protect the expandable member 832
and/or the patient. Once the expandable member 832 is properly
positioned, it may be expanded to substantially seal the aneurysm
90 from the vessel 92, as shown in FIG. 52A. Preferably, the
expandable member 832 substantially engages the outer tubular
member 812, e.g., to enhance the seal against the vessel 92 and/or
to prevent axial movement of the outer tubular member 812 relative
to the aneurysm 90.
[0230] Material, such as blood, other fluid, and/or particulate,
may be aspirated from aneurysm, e.g., to substantially clear the
interior of the aneurysm 90. Preferably, as shown in FIG. 52B,
heparinized saline or other isotonic solution with or without a
contrast agent is delivered, e.g., via the lumen 826 within the
inner tubular member 822, into the aneurysm 90 to facilitate
clearing the interior of the aneurysm 90. More preferably, the
saline or other solution is infused into the aneurysm 90
substantially simultaneously with aspirating excess fluid, e.g.,
saline, solution, blood, and/or loose particulate, from the
aneurysm 90, e.g., using an actuator such as the system 850 shown
in FIG. 53.
[0231] Because of the occlusion member 830, the fluid being infused
into and/or aspirated from the aneurysm 90 without leaking
substantially into the vessel 92. In alternative embodiment, the
occlusion member 830 may not be expanded to substantially seal the
aneurysm 90 during the infusion and/or aspiration of fluid to clear
the aneurysm, e.g., if the fluid is substantially harmless if it
travels downstream in the vessel 92.
[0232] Turning to FIG. 52C, a therapeutic fluid may then be
delivered into the aneurysm 90. The therapeutic fluid may be
intended to cause a variety of reactions within the aneurysm 90,
e.g., cellular lysis, disruption of cellular adhesions, and/or
disruption of cellular function. For example, the therapeutic fluid
may include distilled water, a hypo-osmotic solution, a
hyper-osmotic solution, a detergent, a membrane disruptive polymer
solution, and/or a membrane disruptive protein solution capable of
causing cellular lysis within the wall of the aneurysm 90.
[0233] In addition or alternatively, the therapeutic agent may
include a solution capable of disrupting intercellular adhesions,
such as proteolytic enzymes (e.g., trypsin), or other agents that
disrupt adhesive connections between cells. In a further
alternative, the therapeutic fluid may include a solution capable
of disrupting or ceasing one or more cellular functions, such as
ethanol, a chemotherapeutic agent, a cytostatic agent, and/or a
cytotoxic agent. Optionally, the therapeutic agent may include
x-ray contrast, e.g., to identify when at least some therapeutic
agent remains within the aneurysm 90.
[0234] As shown in FIG. 52D, once the therapeutic agent has had an
opportunity to act within the aneurysm, the therapeutic fluid may
be aspirated from the aneurysm. Preferably, fluid, such as saline
or other isotonic solution with or without a contrast agent, is
infused into the aneurysm 90 substantially simultaneously with
aspirating excess fluid including the therapeutic fluid from the
aneurysm. Alternatively, sufficient vacuum may be maintained such
that the expandable member 852 may be at least partially collapsed,
thereby allowing fluid from the vessel 92 to enter the aneurysm 90
and fill the void as fluid is aspirated.
[0235] Finally, as shown in FIG. 52E, once the therapeutic agent
has been substantially removed from the aneurysm 90, the expandable
member 832 may be collapsed, e.g., by aspirating the fluid infused
into the expandable member 832. The outer tubular member 812, inner
tubular member 822, and/or the occlusion member 850 may then be
removed from the vessel 92 and from the patient's body, e.g., using
conventional procedures.
[0236] Turning to FIG. 54, a similar method is shown for treating
an arterio-venous malformation 94 that extends between an artery 96
and a vein 98. Unlike the previous embodiment, separate balloon
catheters 860, 870 may be introduced into the artery 96 and the
vein 98 using conventional methods. Once positioned as desired,
balloons 862, 872 on the catheters 860, 870 may be expanded to
engage the artery 96 and vein 98, respectively, thereby
substantially isolating the malformation 94 from the artery 96 and
vein 98.
[0237] Fluid within the malformation 94 may be aspirated, e.g.,
using the catheter 870 either alone or in conjunction with infusion
of saline and the like, e.g., using the catheter 860. Thus, one
catheter may be used for infusion while the other is used for
aspiration. Optionally, the system 850 shown in FIG. 53 or other
actuator may be used to infuse and aspirate substantially
simultaneously, as described above. Once the malformation is
sufficiently cleared, a therapeutic agent, similar to those
described above, may be introduced, e.g., from one or both
catheters. Optionally, excess fluid may be aspirated from the
malformation 94 either during or after the therapeutic agent is
introduced, similar to the method described above. Once the
therapeutic agent has remained within the malformation 94 for
sufficient time, the therapeutic agent may be aspirated, e.g., in
conjunction with fluid infusion, similar to the previous
embodiments. The balloons 862, 872 may be collapsed and the
catheter 860, 870 removed from the artery 96 and vein 98.
[0238] Alternatively, a similar method may be used for introducing
a de-endothelialization agent into other blood vessels. For
example, a balloon catheter, similar to those described above may
be introduced into a blood vessel adjacent a target treatment site
within a blood vessel, e.g., from a retrograde approach (not
shown). A balloon or other occlusion member may be expanded to
engage the wall of the vessel, and a therapeutic fluid may be
introduced via the catheter into the target side, e.g., distal to
or upstream from the balloon. The fluid may at least partially
de-endothelialize the vessel wall, e.g., to cause fibrous growth
that may strengthen the vessel wall and/or may occlude the vessel
at the treatment site.
[0239] B. Delivery of De-Endothelialization Fluid Using an
Implantable Device
[0240] De-endothelialization fluid 350 may also be delivered to an
aneurysm or other body lumen using an implantable device, such as a
vaso-occlusive device. FIG. 47 shows a de-endothelialization device
700 that may be used to deliver a de-endothelialization fluid or
composition to an aneurysm or other body lumen. The
de-endothelialization device 700 includes a core member 702 and a
fiber 704 secured to the core member 702. The fiber 704 is capable
of absorbing and/or retaining fluid, e.g., by capillary action.
Alternatively, the fiber 704 may carry de-endothelialization agents
that are chemically or physically attached to the fiber 704.
[0241] FIG. 48 shows a variation of the de-endothelialization
device 700 in which the fiber 704 is substantially longitudinally
oriented and is secured to the core member 702 at one or more
locations 706 along a length of the core member 702. FIG. 49 shows
another variation of the de-endothelialization device 700 in which
one or more fibers 704 are arranged into a mesh that is secured to
the core member 702. The fiber(s) 704 may be arranged in a variety
of patterns and are not limited to those shown previously.
[0242] The core member 702 may be made from a variety of materials.
In general, any of the materials discussed previously with
reference to the core member 12 of FIG. 1 is also applicable the
core member 702 of the de-endothelialization device 700. The core
member 702 may also assume a variety of shapes. Any of the shapes
discussed previously with reference to FIGS. 1-11 may also be
used.
[0243] When using the de-endothelialization device 700, the
de-endothelialization device 700 may be dipped into a
de-endothelialization fluid, which may be absorbed and/or otherwise
retained by the fiber 704 of the de-endothelialization device 700.
The de-endothelialization device 700 may then be delivered to an
aneurysm or other body lumen using any of the methods described
previously with reference to FIGS. 12-15, or any conventionally
known method. After the de-endothelialization device 700 contacts
the endothelium of the aneurysm or other body lumen, the fluid 350
then causes the endothelium to be disrupted, as discussed
previously.
[0244] It should be noted that instead of using the
de-endothelialization device 700 described previously, a similar
procedure may be completed using any implantable object, such as a
vaso-occlusive device. In particular, a vaso-occlusive device may
be dipped into de-endothelialization fluid, which may then adhere
to a surface of the vaso-occlusive device by surface adhesion. The
vaso-occlusive device, carrying the fluid, may then be delivered to
an aneurysm or other body lumen.
[0245] FIG. 50 shows another de-endothelialization device 720 that
includes a core member 722 and a coating 724 secured to the core
member 722. The coating 724 is preferably secured to the core
member 722 during manufacturing. However, the coating 724 may also
be applied on the core member 722 by a user immediately before a
procedure. The coating 724 may be applied to the core member 722,
for example, by dipping the core member 722 into a solution. The
coating 724 may contain similar de-endothelializing ingredients,
such as a cytotoxic agent, as that of de-endothelialization fluids
described above. When the de-endothelialization device 720 is
placed within an aneurysm, a body temperature and/or a chemical
reaction may be used to degrade or dissolve the coating 724 to
release the de-endothelializing ingredients. When the endothelium
of the aneurysm or other body lumen is contacted by the
de-endothelializing ingredients, the endothelium is then
disrupted.
[0246] De-endothelialization fluid 350 may also be delivered via a
hydrogel coating. FIG. 51 shows a de-endothelialization device 730
having a hydrogel coating 732 coupled to a core member 734. The
hydrogel coating 732 is capable of absorbing a desired amount of
de-endothelialization fluid. Examples of hydrogels include gels
formed from polysaccharides, mucopolysaccharides, polyaminoacids,
proteins that support cell growth and healing, polyphosphazines,
polyphosphoesters, polyethylene glycol, polyethylene oxide,
polyvinyl alcohol, polyvinylpyrrolidone, polyethyloxazoline,
polyethylene oxide-co-polypropyleneoxide block copolymers,
PGA-PEG-PGA block copolymers, PGA-PEG diblock copolymers,
acrylates, carboxy alkyl celluloses, partially oxidized cellulose,
polymers and oligomers of glycolide and lactide, polylactic acid,
polyesters of .alpha.-hydroxy acids, polylactones,
polycaprolactones, polyanhydrides, polyorthoesters, polydioxanone,
styrene, acrolein and combinations thereof. Other examples of
hydrogels may also include gels formed from hyaluronic acid,
dextran, heparin sulfate, chondroitin sulfate, heparin, agar,
starch, alginate, fibronectin, gelatin, collagen, fibrin, pectins,
albumin, ovalbumin, collagen-hydroxyethyl-methacrylate (HEMA);
diacrylates, oligoacrylates, methacrylates, dimethacrylates,
oligomethoacrylates, PEG-oligoglycolylacrylates, carboxymethyl
cellulose, polyesters of lactic acid, polyesters of glycolic acid,
poly(.alpha.-hydroxy) acids including polyglycolic acid,
poly-DL-lactic, poly-L-lactic acid, and terpolymers of DL-lactide
and glycolide, .epsilon.-caprolactone, .epsilon.-caprolactone
copolymerized with polyesters, poly(.epsilon.-caprolactone),
poly(.delta.-valerolactone), poly(gamma-butyrolactone), and
combinations thereof. When using the de-endothelialization device
730, the de-endothelialization device 730 is first dipped into
de-endothelialization fluid. Due to the absorptive characteristic
of the hydrogel coating 732, the hydrogel coating 732 absorbs the
fluid and retains the fluid within the coating 732.
[0247] The endothelialization device 730 may then be delivered to
an aneurysm or other body lumen using any of the methods discussed
previously. Once situated inside the sac of the aneurysm or at the
site of another body lumen, the fluid may diffuse from the hydrogel
coating 732 and contact the endothelium of the aneurysm or other
body lumen to disrupt the endothelium.
[0248] Although several embodiments and methods of
de-endothelializing an aneurysm or other body lumen have been
described, it should be noted that one or more of the above
described embodiments may be combined with another. For example,
the de-endothelialization device 10 described with reference to
FIGS. 1-11 may also be heated and/or dipped into
de-endothelialization fluid to enhance its de-endothelialization
properties. Also, the de-endothelialization device 300 described
previously with reference to FIG. 30 can also include an abrasive
element 14, such as that shown in FIG. 1, to enhance its
de-endothelialization property. Combination of other embodiments
described previously may also be used.
[0249] Furthermore, although the embodiments have been discussed
with reference to treating aneurysms, the scope of the invention
should not be so limited. For example, any of the above described
embodiments may also be used to de-endothelialize vascular tissue
for treating arteriovenous malformations (AVMs), arteriovenous
fistulas (AVFs), or other vascular conditions. Other bodily tissues
may also be de-endothelialized for treatment of various medical
conditions, such as tumors, using any of the above discussed
devices and/or methods.
[0250] Thus, although several preferred embodiments have been shown
and described, it would be apparent to those skilled in the art
that many changes and modifications may be made thereto without
departing from the scope of the invention, which is defined by the
following claims and their equivalents.
* * * * *