U.S. patent application number 12/580565 was filed with the patent office on 2010-04-22 for shape memory tubular stent with grooves.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to Claude O. Clerc, Francisca Tan.
Application Number | 20100100170 12/580565 |
Document ID | / |
Family ID | 41449894 |
Filed Date | 2010-04-22 |
United States Patent
Application |
20100100170 |
Kind Code |
A1 |
Tan; Francisca ; et
al. |
April 22, 2010 |
SHAPE MEMORY TUBULAR STENT WITH GROOVES
Abstract
An implantable, radially distensible stent includes a tubular
structure having opposed open ends. The wall of the stent is made
from a shape memory polymeric material. Grooves may be disposed
within an outer surface of stent wall to improve flexibility and
drainage of the stent.
Inventors: |
Tan; Francisca; (Wayland,
MA) ; Clerc; Claude O.; (Marlborough, MA) |
Correspondence
Address: |
HOFFMANN & BARON, LLP
6900 JERICHO TURNPIKE
SYOSSET
NY
11791
US
|
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
Maple Grove
MN
|
Family ID: |
41449894 |
Appl. No.: |
12/580565 |
Filed: |
October 16, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61107440 |
Oct 22, 2008 |
|
|
|
Current U.S.
Class: |
623/1.18 ;
264/209.1; 264/400; 623/1.11; 623/1.15 |
Current CPC
Class: |
A61F 2/07 20130101; A61F
2/89 20130101; A61F 2002/041 20130101; A61F 2210/0014 20130101;
A61F 2/844 20130101; A61F 2/848 20130101; A61F 2230/0069 20130101;
A61F 2/958 20130101; A61F 2250/0039 20130101; A61F 2/94 20130101;
A61F 2250/0029 20130101; A61F 2250/0036 20130101; A61F 2002/072
20130101; A61F 2230/0091 20130101 |
Class at
Publication: |
623/1.18 ;
623/1.15; 623/1.11; 264/209.1; 264/400 |
International
Class: |
A61F 2/06 20060101
A61F002/06; D01D 5/24 20060101 D01D005/24; B29C 35/08 20060101
B29C035/08 |
Claims
1. An implantable, radially distensible device comprising: a
tubular structure having an open first end and an opposed open
second end, the tubular structure having a wall between said first
open end and said second end to define an open lumen therethrough,
the wall having an outer surface and an opposed inner surface
defining a wall thickness therebetween; the wall comprising a shape
memory polymeric material; wherein the tubular structure is a
self-supporting wall structure.
2. The device of claim 1, wherein the tubular structure has a
substantially solid wall and has a plurality of grooves disposed
within the outer surface of said wall.
3. The device of claim 2, wherein the grooves are present in the
wall when the device is in a radially contracted state and in a
radially expanded state.
4. The device of claim 2, wherein the grooves are selected from the
group consisting of a semicircular groove, a truncated circular
groove, a semicircular groove with rounded surfaces, a groove
having a flat bottom portion and smoothly rounded sides, a
triangular-shaped groove, a groove having a flat bottom portion and
sloped sides, a square-shaped groove, a rectangular-shaped groove,
and combinations thereof.
5. The device of claim 2, wherein the grooves are a plurality of
radially orientated grooves.
6. The device of claim 2, wherein the grooves are a plurality of
helically orientated grooves.
7. The device of claim 2, wherein the grooves are a plurality of
interconnected helically orientated grooves having a first helical
pattern and a second helical pattern.
8. The device of claim 11, wherein the grooves are crisscrossed
helical grooves.
9. The device of claim 2, wherein the grooves are interconnected
grooves.
10. The device of claim 1, wherein the shape memory polymeric
material of the wall of the device comprises shape memory polymeric
polycyclooctene.
11. The device of claim 2, wherein the grooves comprise a depth and
wherein the depth the grooves are from about 5% to about 50% of the
wall thickness.
12. The device of claim 1, further comprising: at least two tubular
structures and a graft engaging the at least two tubular
structures, wherein the at least two tubular structures are spaced
apart from one and the other.
13. A method of making a stent, comprising: providing a shape
memory polymer; forming the shape memory polymer into a tubular
structure having an open first end and an opposed open second end,
the tubular structure having a wall between said first open end and
said second end to define an open lumen therethrough, the wall
having an outer surface and an opposed inner surface defining a
wall thickness therebetween; and disposing grooves within the outer
surface of the wall.
14. The method of claim 13, wherein the step of providing the shape
memory polymer further comprises providing shape memory polymeric
polycyclooctene.
15. The method of claim 13, wherein the step of forming the shape
memory polymer into the tubular structure is selected from the
group consisting of molding the shape memory polymer, casting the
shape memory polymer, extruding the shape memory polymer, and
combinations thereof
16. The method of claim 13, wherein the step of disposing grooves
within the outer surface of the wall is selected from the group
consisting of mechanically forming the grooves, milling the outer
surface of the wall, grinding the outer surface of the wall,
cutting the outer surface of the wall, laser cutting the outer
surface of the wall, etching the outer surface of the wall, masking
the outer surface of the wall, removing a sacrificial layer or
filament from the outer surface, molding the grooves within the
outer surface of the wall, and combinations thereof.
17. A method for intraluminal delivery of a stent, comprising
providing an assembly, comprising: a delivery device having an
elongate tube; and a radially distensible stent comprising: a
tubular structure having an open first end and an opposed open
second end, the tubular structure having a wall between said first
open end and said second end to define an open lumen therethrough,
the wall having an outer surface and an opposed inner surface
defining a wall thickness therebetween; the wall comprising a shape
memory polymeric material; and grooves disposed within the outer
surface of said wall; wherein the stent is disposed in a contracted
state on the elongate tube of the delivery device; advancing the
assembly to a site within a bodily lumen; radially expanding the
stent within the bodily lumen; and withdrawing the delivery device
to leave the stent within the bodily lumen.
18. The method of claim 17, wherein the step of radially expanding
the stent within the bodily lumen further comprises supplying heat
from a heat source to the stent to radially expand the stent.
19. The method of claim 17, wherein the step of radially expanding
the stent within the bodily lumen further comprises providing an
expandable member to mechanically radially expand the stent.
20. The method of claim 17, further comprising: providing an
expandable member to mechanically expand the stent.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/107,440, filed Oct. 22, 2008, the contents of
which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates to a polymeric stent stent. More
particularly, the invention relates to a shape memory polymeric
stent having grooves.
BACKGROUND OF THE INVENTION
[0003] An intraluminary prosthesis is a medical device used in the
treatment of diseased bodily lumens. One type of intraluminary
prosthesis used in the repair and/or treatment of diseases in
various body vessels is a stent. A stent is generally a
longitudinal tubular device formed of biocompatible material which
is useful to open and support various lumens in the body. For
example, stents may be used in the bodily vessel, such as in the
coronary or peripheral vasculature, esophagus, trachea, bronchi
colon, biliary tract, urinary tract, prostate, brain, as well as in
a variety of other applications in the body. These devices are
implanted within the vessel to open and/or reinforce collapsing or
partially occluded sections of the lumen.
[0004] While stents are often made from metallic materials, the use
of plastic stents is not uncommon, especially in non-vascular
applications. For example, plastic stents have been used to treat
malignant or benign strictures throughout the gastrointestinal
tract because of, among other things, ease of placement and
non-permanency of the stents. Benign strictures in biliary
applications are often treated every three months with a plastic
stent for up to about a year. Rigid plastic tubes were also used to
treat esophageal strictures, but have been replaced by
self-expanding stents.
[0005] Each year many patients are diagnosed with malignant biliary
disease. Other diagnosis include benign disease, post surgical and
questionable malignant. Typically, a patient with biliary disease
presents symptoms such as jaundice, weight loss, abdominal pain,
and back pain. These patients often suffer from an obstruction in
the pancreaticobiliary ductal system. Numerous diseases can cause
the inability of bile flow, however, the presence of gallstones
and/or strictures is the most prevalent. For benign strictures,
stenting or cathetering may be a useful resolution. Some stents or
catheters, however, commonly get blocked and clog up. The patient
often returns for another stent or catheter, where the physician
often does not remove the previous stent or catheter and simply
inserts another stent or catheter. Patients with benign strictures
often have 4 to 5 stent or catheter packed into their common bile
ducts. Usually, bile ducts can remodel, but 20% don't after
multiple stent or catheter insertions.
[0006] Such plastic stents or catheters may have fairly thick
walls. Such thick walls may make delivery through curved lumens
difficult. Further, such thick walled devices may not be
flexible.
[0007] Thus, there is a need for a polymeric stent which has
improved patency by reducing re-intervention rates due, for
example, to tumor in-growth, while still being flexible so that it
can used in curved lumens.
SUMMARY OF THE INVENTION
[0008] In one embodiment, the present invention is directed to a
shape memory stent. The shape memory tubular stent has applications
in bodily lumens, such as but not limited to the common bile duct,
pancreatic duct and hepatic ducts where a solid stent is needed and
where in-growth can occur due to proliferating oncologous cells.
The shape memory tubular stent may further include grooves into its
outer surface to increase flexibility of the stent. Having grooves
on the outside surface of the stent may also decrease pancreatitis
and prevent migration. The grooves may allow the secretion of bile
from other bifurcating ducts (pancreatic and hylar ducts) over the
outside of the stent. The grooves may also allow some cellular
in-growth on the outside of the stent. The stent may be a solid
tube without substantial openings for the prevention of cellular
in-growth. Decreasing pancreatitis by not blocking flow from the
bifurcating ducts of the common bile duct may also be accomplished
by placing small holes into the stent. The holes may be distant for
each other to decrease cellular in-growth.
[0009] In one embodiment, the invention is directed to an
implantable, radially distensible device or stent comprising a
tubular structure having an open first end and an opposed open
second end, the tubular structure having a wall between said first
open end and said second end to define an open lumen therethrough,
the wall having an outer surface and an opposed inner surface
defining a wall thickness therebetween; the wall comprising a
polymeric material; and grooves disposed within the outer surface
of said wall; wherein the tubular structure is a self-supporting
wall structure. The stent may be radially distensible between a
radially contracted state and a radially expanded state. Desirably,
the self-supporting wall structure does not have an open lattice
wall structure or gaps in both radially contracted and radially
expanded states. Further, the stent wall may be self-supporting
without other support structure incorporated into or abutting the
tubular structure.
[0010] The grooves may be present in the wall when the stent is in
a radially contracted state, in a radially expanded state. The
shape of the grooves may include or comprise a semicircular groove,
a truncated circular groove, a semicircular groove with rounded
surfaces, a groove having a flat bottom portion and smoothly
rounded sides, a triangular-shaped groove, a groove having a flat
bottom portion and sloped sides, a square-shaped groove, a
rectangular-shaped groove, and combinations thereof. The grooves
may be a plurality of radially orientated grooves, a plurality of
helically orientated grooves, a plurality of interconnected
grooves, including interconnected helically orientated grooves
having a first helical pattern and a second helical pattern, such
as crisscrossed helical grooves, and combinations thereof.
[0011] The polymeric material of the stent wall may comprise shape
memory polymer. A useful polymeric material of the stent wall may
comprise shape memory polymeric polycyclooctene. The polymeric
material of the stent wall may further include a radiopaque
material.
[0012] In another embodiment an open lattice stent wall structure
of shape memory polymeric material is provided. The open lattice
wall structure may be contiguous or may include spaced apart stent
members. A graft may be disposed over the stent wall structure, may
be disposed in between the open spaces within the stent wall
structure, or may embed or surround the stent wall structure, or
otherwise simply engage the stent structure. The graft may be made
from a material that is different from the shape memory polymeric
material of the open lattice stent wall structure to provide a
composite implantable device or stent-graft.
[0013] In another embodiment, the invention is directed to a method
of making a stent. The method may comprise the steps of providing a
shape memory polymer; forming the shape memory polymer into a
tubular structure having an open first end and an opposed open
second end, the tubular structure having a wall between said first
open end and said second end to define an open lumen therethrough,
the wall having an outer surface and an opposed inner surface
defining a wall thickness therebetween; and disposing grooves
within the outer surface of the wall. The step of providing the
shape memory polymer may further comprise providing shape memory
polymeric polycyclooctene. The step of forming the shape memory
polymer into the tubular structure may further comprise molding the
shape memory polymer, casting the shape memory polymer, and/or
extruding the shape memory polymer. The step of disposing grooves
within the inner surface of the wall may further comprise
mechanically forming the grooves, such as by milling, grinding,
cutting, laser cutting, masking and/or etching the outer surface of
the wall to form the grooves; and/or step of disposing grooves
within the outer surface of the wall may further comprise molding
the grooves and/or removing a sacrificial layer or filament to so
form the grooves.
[0014] In another embodiment, the invention is directed to an
assembly for intraluminal delivery of a stent. The assembly may
comprise a delivery device having an elongate tube; and a radially
distensible stent comprising a tubular structure having an open
first end and an opposed open second end, the tubular structure
having a wall between said first open end and said second end to
define an open lumen therethrough, the wall having an outer surface
and an opposed inner surface defining a wall thickness
therebetween; the wall comprising a shape memory polymeric
material; and grooves disposed within the outer surface of said
wall; wherein the stent is disposed in a contracted state on the
elongate tube of the delivery device. The delivery device may
further comprise an expandable balloon or other mechanical
expanding device, a heat source, and combinations thereof
[0015] In another embodiment, the invention is directed to a method
for intraluminal delivery of a stent. The method may comprise the
steps of providing an assembly, which may comprise a delivery
device having an elongate tube; and a radially distensible stent
comprising a tubular structure having at least an open first end
and an opposed open second end, the tubular structure having a wall
between said first open end and said second end to define an open
lumen therethrough, the wall having an outer surface and an opposed
inner surface defining a wall thickness therebetween; the wall
comprising a shape memory polymeric material; and grooves disposed
within the outer surface of said wall; wherein the stent is
disposed in a contracted state on the elongate tube of the delivery
device; advancing the assembly to a site within a bodily lumen;
radially expanding the stent within the bodily lumen; and
withdrawing the delivery device to leave the stent within the
bodily lumen. Further, the stent of the present invention may
comprise multiple openings and/or multiple lumens.
[0016] Moreover, the structure of the present invention may
comprise a shape memory polymer and other material. For example,
shape memory polymer may be layered over a flexible graft or stent
which may comprise a different material from the shape memory
material or may comprise a similar or the same material as from the
shape memory material. The other material may also be shape memory,
including polymeric materials and non-polymeric materials, for
example metallic shape memory materials.
[0017] These and other embodiments, objectives, aspects, features
and advantages of this invention will become apparent from the
following detailed description of illustrative embodiments thereof,
which is to be read in connection with the accompanying drawings in
which like reference characters refer to the same parts or elements
throughout the different views. The drawings are not necessarily to
scale, emphasis instead being placed upon illustrating the
principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a perspective view of a stent according to the
present invention.
[0019] FIG. 2 is a cross-section view of the stent of FIG. 1 taken
along the 2-2 axis.
[0020] FIG. 3 is a side elevational view of the stent of FIG. 1
taken along the 3-3 axis showing radial grooves disposed on the
outer surface of the stent.
[0021] FIG. 4 is an exploded view of a portion of the stent of FIG.
4.
[0022] FIG. 5 depicts an alternate embodiment of the stent of FIG.
3 showing helical grooves disposed on the outer surface of the
stent.
[0023] FIG. 6 depicts an alternate embodiment of the stent of FIG.
3 showing helically crisscrossing grooves disposed on the outer
surface of the stent.
[0024] FIG. 7 depicts an alternate embodiment of the stent of FIG.
1 showing a stent with non-rounded stent ends.
[0025] FIG. 8 depicts an alternate embodiment of the stent of FIG.
3 showing a stent with different inter-connected and
non-interconnected grooves.
[0026] FIGS. 9A through 9E depict different shapes for the grooves
on the surface of the stent.
[0027] FIG. 10 depicts an alternate embodiment of the stent of FIG.
3 showing holes disposed on the stent.
[0028] FIG. 11 is a cross-sectional view of the stent of FIG. 10
taken along the 11-11 axis depicting a hole through the stent
wall.
[0029] FIG. 12 is a partial view of the stent of FIG. 3 depicting
the stent in a radially contracted state.
[0030] FIG. 13 is a partial view of the stent of FIG. 3 depicting
the stent in a radially expanded state.
[0031] FIG. 14 is a schematic of the stent of FIG. 3 in a
contracted state and being disposed over a delivery device.
[0032] FIG. 15 is a schematic of the stent of FIG. 14 being
radially expanded from the delivery device by action of heat.
[0033] FIG. 16 is a schematic of the stent of FIG. 3 in a
contracted state and being disposed over a delivery device having
an expandable balloon.
[0034] FIG. 17 is a schematic of the stent of FIG. 16 being
radially expanded from the delivery device by action of pressure
from expanding the balloon and/or by the application of heat.
[0035] FIG. 18 depicts an alternate embodiment of the stent of FIG.
1 having no external grooves in its outer wall surface.
[0036] FIG. 19 depicts a stent-graft according to an alternate
embodiment of the present invention.
[0037] FIG. 20 is a cross-sectional view of the stent-graft of FIG.
19 taken along the 20-20 axis.
[0038] FIG. 21 depicts another embodiment of a stent-graft
according to the present invention.
[0039] FIGS. 22A and 22B are cross-sectional views of the
stent-graft of FIG. 21 taken along the 22-22 axis.
[0040] FIG. 23 depicts yet another embodiment of a stent-graft
according to the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0041] FIG. 1 illustrates a perspective view of an implantable,
radially distensible device or stent 10 of the present invention.
Stent 10 is a tubular structure having a wall 12 and opposed open
ends 14, 16, defining an open lumen 18 therebetween. The length, L,
of the stent may vary from about 1 cm (or about 0.4 inches) to
about 15 cm (or about 6 inches). Such lengths are non-limiting, and
the stent 10 may have any suitable length for its intended purpose.
The stent 10 may further include a plurality of grooves 22 disposed
within the outer surface 20 of the stent 10. The grooves 22 may be
fully or partially circumferential. The ends 14, 16 may be rounded
or smooth to facilitate delivery of the stent 10 within a bodily
lumen (not shown) and/or to provide for smooth flow of a bodily
fluid (not shown) at the ends 14, 16 and/or through open lumen 18.
Further, the edge of the ends 14, 16 that are proximal to the open
lumen 18 may also be rounded and/or may be curved inward, i.e.,
concavely shaped as depicted in FIG. 3.
[0042] FIG. 2 illustrates a cross-sectional view of the stent 10 of
FIG. 1 taken along the 2-2 axis. The stent wall 12 includes an
outer surface 20 and an inner surface 21. The inner surface 21 of
the stent wall 12 may also define the open lumen 18 of the stent
10. The stent wall 12 depicted in FIG. 2 is a substantially solid
tubular wall, i.e., free and/or substantially free of an open
lattice structure having gaps in the wall. In one embodiment, the
stent wall 12 is a unitary structure, which may suitably be formed
by molding, casting, extruding, and the like, as contrasted to a
non-unitary structure, such as a stent wall formed from a plurality
of elongate filaments. The thickness, W, of the stent wall 12 may
vary. In the same or different embodiment, the thickness of the
stent wall 12 is selected, in part, to provide a self-supporting
tubular structure. The thickness, W, may vary from about 0.038 cm
(or about 0.015 inches) to about 0.635 cm (or about 0.25 inches).
These wall thicknesses are non-limiting, and any suitable wall
thickness may be used.
[0043] FIG. 3 illustrates a side elevational view of the stent 10
of FIG. 1, taken along the 3-3 axis. The stent 10 may include a
series or plurality of radially or circumferentially disposed
grooves 22. Desirably, the grooves 22 are disposed at a frequency
or spacing along the longitudinal length, L, of the stent 10. For
example, grooves 22 may be disposed at a length X between
juxtaposed grooves 22. For example, X may vary from about 0.25 cm
(or about 0.1 inches) to about 3 cm (or about 1.2 inches). These
frequencies or spacings are non-limiting, and any desirable
frequency or spacing may suitably be used. Further, the frequency
or spacing of the grooves 22 may be regular, equal, substantially
equal and/or somewhat equal along the longitudinal L of the stent
10. The present invention, however, is not so limited. For example,
only portions of the longitudinal expanse of the stent 10 may have
a frequency or spacing of grooves 22 while other longitudinal
portions of the stent 10 may be free of such grooves (not shown).
Further, the grooves 22 may also be disposed over and into the
surface of the stent 10 in irregular pattern (not shown). Further,
the grooves 22 may be fully or partially circumferential. Moreover,
the grooves 22 may have any suitable geometry, such as but not
limited to semi-circular, angular, semi-polygonal and the like. The
grooves 22 in the stent 12 may be formed directly during the
molding or casting of the stent 10. Alternatively, or in addition
to, the grooves 22 may be machined into the stent wall 12 by, for
example but not limited to, milling, grinding, cutting, laser
cutting, etching and the like. Moreover the grooves 22 may be
formed masking or by the use of a sacrificial layer or
filament.
[0044] FIG. 4 is an exploded view of a portion of the stent wall 12
of FIG. 3. The groove 22 may have a depth Y. Desirably, the depth Y
of the groove 22 into the stent wall 12, as measured from the outer
surface 20 of the stent wall 12, may vary from about 5 percent of
the wall thickness to about 50 percent of the wall thickness W.
Such depths of the grooves 22 are nonlimiting, and any desired
depth may suitably be used. Desirably, the depth Y does not
completely traverse the wall thickness W.
[0045] FIGS. 5 and 6 depict additional arrangements of the grooves
22 within the outer surface 20 of the stent 10 of the present
invention. As depicted in FIG. 5, the grooves 22 may be helically
disposed about the stent 10. As depicted in FIG. 6, the grooves 22
may be crisscrossed helical grooves 22. For example, groove 22' and
groove 22'' may have different helical orientations, for example
approximately opposite helical orientations. The grooves 22' and
22'' may intersect at grooved portion 24. The present invention,
however, is not so limited and any useful regular or irregular
pattern of grooves may suitably be used.
[0046] FIGS. 7 and 8 depict additional embodiments of the present
invention. For example, the ends 14, 16 need not be rounded as
depicted in FIGS. 1, 3, 5 and 6, and as depicted in FIG. 7 the ends
14' and 16' may be non-rounded or flat, including substantially
flat and partially flat ends. Moreover, the stent 10 may have any
further features or shapes useful for treatment within a bodily
lumen, including flares, tapers, bumps, varying diameters, surface
features, anchors and the like. One example of surface features
include an outwardly extending geometric pattern which may serve as
an anti-migration feature. Further details of stent having such
anti-migration features, including stents of shape memory polymeric
material, may be found in U.S. patent application Ser. No.
12/139,042, filed Jun. 13, 2008, which published as U.S. Patent
Application Publication No. 2008/0319540 A1 on Dec. 25, 2008, the
contents of which is incorporated herein by reference.
[0047] Further, as depicted in FIG. 8, grooves 22 may be
interconnected by grooves 23, 23' which may have different
orientations from the circumferential grooves 22 of FIG. 1 and the
helical grooves 22 of FIG. 5. For example, groove 23 may be a
longitudinal or substantially longitudinal groove, and groove 23'
may be a helical interconnecting groove with a different helical
orientation from helical grooves 22''. Furthermore, as depicted in
FIG. 8, the stent 10 of the present invention may include a
combination arrangements of the circumferential grooves 22 and
helical grooves 22''. Thus, the stent 10 may include combinations
of helical and non-helical grooves, which may be in part or total,
interconnected or non-interconnected.
[0048] FIGS. 9A through 9E depict nonlimiting examples of
additional suitable shapes of the grooves. For example, in addition
to the semicircular or truncated circular groove 22 as depicted in
FIG. 4, groove 22a, as depicted in FIG. 9A, may include a
semicircular groove 30 with rounded surfaces 32 proximal to the
outer surface 20 of the stent wall 12. As depicted in FIG. 9B,
groove 22b may include a flat or somewhat flat bottom portion 34
and smooth, somewhat rounded, sides 36. As depicted in FIG. 9C,
groove 22c may include a triangular shape 28. Further, as depicted
in FIG. 9D, groove 22d may include a flat or somewhat flat bottom
portion 40 and sloped sides 42. The groove 22d may be described as
having a shape of a truncated hexagonal configuration. Moreover, as
depicted in FIG. 9E, groove 22e may have a square shape 44 or even
a rectangular shape (not shown). Further, any of the depicted
shapes having sharp or pointed edges may be suitable be modified to
include rounded and/or smooth edges. The stent 10 may include any
of the grooves 22, 22a, 22b, 22c, 22d, 22e, as depicted or modified
as described above, for example modified to include rounded or
smooth edges, in total or in combination.
[0049] As depicted in FIGS. 10 and 11, the stent 10 may include a
hole 26 or a plurality of holes 26. The holes 26 may decrease
pancreatitis by not blocking flow from bifurcating ducts of the
common bile duct after the stent 10 has been so positioned. As
depicted in FIG. 10, the holes 26 may be distant from one and the
other to decrease then potential for or to inhibit cellular
in-growth. The holes 26 may be disposed in any useful pattern,
including regular repeating patterns and irregular patterns. As
depicted in FIG. 11, the hole 26 may traverse through the stent
wall 12. The holes may have any shape, for example but not limited
to circular, slotted, polygonal and the like.
[0050] As described above, the stent 10 and the stent wall 12
desirably comprise, include or are made from shape memory polymers
or shape memory polymeric materials. Shape memory refers to the
ability of a material to undergo structural phase transformation
such that the material may define a first configuration under
particular physical and/or chemical conditions, and to revert to an
alternate configuration upon a change in those conditions. Stimulus
for such a phase transformation may include, but is not limited to,
temperature, pH, salinity, hydration, pressure and others.
[0051] Shape memory polymers generally have hard segments and soft
segments, which are relative terms relating to the transition
temperature of the segments. As used herein, the term "segment"
refers to a block or sequence of polymer forming part of the shape
memory polymer. Generally speaking, hard segments have a higher
glass transition temperature (Tg) than soft segments.
[0052] Useful natural polymer segments or polymers include, but are
not limited to, proteins, such as casein, gelatin, gluten, zein,
modified zein, serum albumin and collagen, polysaccharides, such as
alginate, chitin, celluloses, dextrans, pullulane, and
polyhyaluronic acid; poly(3-hydroxyalkanoate)s,
poly(.beta.3-hydroxybutyrate), poly(3-hydroxyoctanoate) and
poly(3-hydroxyfatty acids). Useful natural bioabsorbable or
biodegradable polymer segments or polymers include polysaccharides
such as alginate, dextran, cellulose, collagen and chemical
derivatives thereof, and proteins such as albumin, zein and
copolymers and blends thereof, alone or in combination with
synthetic polymers. Suitable synthetic polymer blocks include
polyphosphazenes, poly(vinyl alcohols), polyamides, polyester
amides, poly(amino acid)s, synthetic poly(amino acids),
polyanhydrides, polycarbonates, polyacrylates, polyalkylenes,
polyacrylamides, polyalkylene glycols, polyalkylene oxides,
polyalkylene terephthalates, polyortho esters, polyvinyl ethers,
polyvinyl esters, polyvinyl halides, polyvinylpyrrolidone,
polyesters, polylactides, polyglycolides, polysiloxanes,
polyurethanes and copolymers thereof. Examples of suitable
polyacrylates include poly(methyl methacrylate), poly(ethyl
methacrylate), poly(butyl methacrylate), poly(isobutyl
methacrylate), poly(hexyl methacrylate), poly(isodecyl
methacrylate), poly(lauryl methacrylate), poly(phenyl
methacrylate), poly(methyl acrylate), poly(isopropyl acrylate),
poly(isobutyl acrylate) and poly(octadecyl acrylate). Synthetically
modified natural polymers include cellulose derivatives such as
alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers,
cellulose esters, nitrocelluloses, and chitosan. Examples of
suitable cellulose derivatives include methyl cellulose, ethyl
cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose,
hydroxybutyl methyl cellulose, cellulose acetate, cellulose
propionate, cellulose acetate butyrate, cellulose acetate
phthalate, arboxymethyl cellulose, cellulose triacetate and
cellulose sulfate sodium salt. Examples of synthetic biodegradable
polymer segments or polymers include polyhydroxy acids, such as
polylactides, polyglycolides and copolymers thereof; poly(ethylene
terephthalate); poly(hydroxybutyric acid); poly(hydroxyvaleric
acid); poly[lactide-co-(.epsilon.-caprolactone)];
poly[glycolide-co-(.epsilon.-caprolactone)]; polycarbonates,
poly(pseudo amino acids); poly(amino acids);
poly(hydroxyalkanoate)s; polyanhydrides; polyortho esters; and
blends and copolymers thereof. Rapidly biodegradable polymers such
as poly(lactide-co-glycolide)s, polyanhydrides, and
polyorthoesters, which have carboxylic groups exposed on the
external surface as the smooth surface of the polymer erodes, can
also be used. In addition, polymers containing labile bonds, such
as polyanhydrides and polyesters, are well known for their
hydrolytic reactivity. Their hydrolytic degradation rates can
generally be altered by simple changes in the polymer backbone and
their sequence structure. Examples of suitable hydrophilic polymers
include, but are not limited to, poly(ethylene oxide), polyvinyl
pyrrolidone, polyvinyl alcohol, poly(ethylene glycol),
polyacrylamide poly(hydroxy alkyl methacrylates), poly(hydroxy
ethyl methacrylate), hydrophilic polyurethanes, poly(hydroxy ethyl
acrylate), hydroxy ethyl cellulose, hydroxy propyl cellulose,
methoxylated pectin gels, agar, starches, modified starches,
alginates, hydroxy ethyl carbohydrates and mixtures and copolymers
thereof. Hydrogels may also be suitably be used and can be formed
from polyethylene glycol, polyethylene oxide, polyvinyl alcohol,
polyvinyl pyrrolidone, polyacrylates, poly (ethylene
terephthalate), poly(vinyl acetate), and copolymers and blends
thereof. Several polymeric segments, for example, acrylic acid, are
elastomeric only when the polymer is hydrated and hydrogels are
formed. Other polymeric segments, for example, methacrylic acid,
are crystalline and capable of phase transition even when the
polymers are not hydrated. Either type of polymeric block can be
used, depending on the desired application and conditions of use.
Additional details of useful shape memory polymeric compositions
may be found in U.S. Pat. No. 6,887,266 to Williams et al., the
contents of which are incorporated herein by reference.
[0053] One useful class of useful shape memory polymers includes a
class of (meth)acrylate compositions having a first (meth)acrylate
monomer having a lower glass transition temperature (Tg), typically
less than about 25.degree. C., and a second (meth)acrylate monomer
having a higher glass transition temperature (Tg), typically
greater than about 25.degree. C. These ranges of glass transition
temperatures are, however, nonlimiting. Useful, but nonlimiting,
first monomers include butyl (meth)acrylate,
pentafluoropropylacrylate and combinations thereof. Useful, but
nonlimiting, second monomers include methylmethacrylate, isobornyl
methacrylate, isobutyl methacrylate, perfluoroacetylmethacrylate,
tertiary butylmethacrylate, phenylethylmethacrylate, styrene,
hydroxyethyl methacrylate, glycerol methacrylate, n-vinyl
pyrrolidone, heptadecafluorodecyl methacrylate and combinations
thereof. Such compositions may include a third of
polyethyleneglycol dimethacrylate, polyethyleneglycol methacrylate,
polyethyleneglycol acrylate and combinations thereof. Additional
details of these compositions may be found in U.S. Pat. No.
7,115,691 to Alvarado et al., U.S. Pat. No. 5,603,722 to Phan et
al. and U.S. Pat. NO. 5,163,952 to Froix, the contents of which are
incorporated herein by reference.
[0054] Other useful shape memory polymers include polynorbornene,
polycaprolactone, polyenes, nylons, polycyclooctene (PCO), blends
of PCO and styrene-butadiene rubber, polyvinyl
acetate/polyvinylidinefluoride (PVAc/PVDF), blends of
PVAc/PVDF/polymethylmethacrylate (PMMA), polyurethanes,
styrene-butadiene copolymers, polyethylene (particularly,
crosslinked polyethylene), trans-isoprene, block copolymers of
polyethylene terephthalate (PET) and blends of polycaprolactone and
n-butylacrylate. Desirably, the stent 10 or the stent wall 12 may
comprise a shape memory polymer of polycyclooctene. Further details
of such polycyclooctene shape memory polymers may be found in U.S.
Pat. Nos. 7,091,297; 7,173,096 and 7,208,550 and in U.S. Patent
Application Nos. 2005/0216074; 2005/0245719; 2005/0251249,
2007/0135578 and 2007/0142562, the contents of all of which are
incorporated herein in their entirety by reference.
[0055] Suitable shape memory polymers for use with the stent 10 of
the present invention may include elastomers that are typically
crosslinked and/or crystalline and exhibit melt or glass
transitions at temperatures that are above body temperature and
safe for use in the body, e.g. at about 40.degree. C. to about
50.degree. C. Such suitable shape memory polymers include those
that maintain stent geometry under expansion conditions where the
stent 10 may be expanded without fracture or substantial
irreversible stress relaxation or creep. Typically, the stent 10
may be heated to or above the melt or glass transition temperature
of the shape memory polymer during expansion. In this condition,
the polymer may be in a softened state. After the stent 10 is fully
expanded and cooled, the shape memory polymer substantially sets in
the proper apposition, e.g. about a bodily lumen. At the same time,
the polymer can have some elastomeric properties in the cooled,
hardened state so that the stent can flex with natural lumen
motion. After cooling, the stent 10 should exhibit sufficient
resistance to inward radial force of a body lumen wall so that the
stent 10 keeps the body lumen open. The stent wall 12 should have
sufficient strength, e.g., thickness and material selection for
strength, so that the stent wall 12 can be kept relatively thin
while still resisting lumen wall forces. The stent wall 12 may be
made of mixtures and/or combinations polymers or multiple polymer
layers.
[0056] Desirably, the stent 10 includes shape memory properties
useful for delivery of the stent 10 within a bodily lumen. The
shape memory polymer of the stent wall 12 can be configured to
remember an enlarged or reduced diameter configuration. For
example, the stent 10 can be delivered into the body in a
contracted or radially reduced state, and then expanded by heat
and/or radial pressure to a larger expanded state. If desired, the
stent 10 may also be retrieved from a bodily lumen by reheating the
stent 10 so that it returns to its contracted state, whereby it
could then be removed and/or repositioned by a practitioner. In
this case, heating causes the stent 10 to revert its smaller
diameter condition, and accordingly the stent can be more easily
removed from the bodily vessel as compared to stents not containing
shape memory materials.
[0057] The stent 10 may be made by extruding or molding a suitable
shape memory polymer and/or polymers to an initial diameter which
may be about the same or greater than the diameter of a target
lumen. The stent wall 12 may be machined, for example by any of the
above-described methods, e.g., laser cutting, to provide a pattern
of grooves 22 in a desirable geometric pattern. Alternatively, or
in addition to, the pattern of grooves 22 may be formed into the
stent wall surface 20 during molding of the stent wall 12. The
shape memory polymer may then be recrystallized or crosslinked, if
necessary. The stent 10 may be heated near or above the melt or
glass transition and mechanically deformed to its smaller or
contracted diameter, such as one suitable for delivery. The stent
10 may then be cooled, typically to room temperature. The stent 10
may be disposed onto a balloon catheter, delivered into the body,
and expanded by application of heat to the melt or glass
transition, while optionally inflating the balloon. As the polymer
or polymers of the stent have shape memory properties, the stent 10
tends to expand upon heating to the larger, remembered diameter. At
the transition temperature, shape memory polymers become malleable
and elastic, thus allowing them to be expanded to sizes greater
than 200%. A useful delivery catheter or endoscope may include a
portion which may be heated or supply heat to expand the stent 10.
The delivery catheter or endoscope may also include an inflatable
balloon or other expander which may also be heated. The inflatable
balloon and/or catheter or endoscope portion may include an
electrically conductive fluid which may be heated by
radio-frequency power. Such a delivery device is further described
in U.S. Pat. No. 5,191,883, the contents of which are incorporated
in their entirety by reference. Other methods may also be used to
heat the stent 10 including circulating heated fluids, resistance
heating, externally supplied heating, and the like.
[0058] FIGS. 12 and 13 depict an exploded portion of the stent 10
of FIG. 3 in a radially contracted state and a radially expanded
state, respectively. As depicted in FIGS. 12 and 13, stent 10 is
radially distensible from a radially contracted state, as indicated
by dimension D.sub.1, to a radially expanded state, as indicated by
dimension D.sub.2, where D.sub.2 is greater than D.sub.1. For
example, the stent 10 may have a contracted diameter D.sub.1 that
is about 10 Fr (or about an outer diameter (OD) of about 3.3 mm).
The stent 10 may be expanded to a larger diameter D.sub.2, for
example, from about 20 Fr (or about 6.7 mm OD) to about 30 Fr (or
about 10 mm OD) or larger. Such diameters are nonlimiting, and the
stent 10 may be formed and programmed to have any suitable
contracted diameter D.sub.1 and any suitable expanded diameter
D.sub.2.
[0059] FIGS. 14 through 17 schematically depict delivery and/or
delivery devices for the stent 10. As depicted in FIG. 14 stent 10
is in its contracted state, i.e., a non-limiting dimension of about
10 Fr (or about 3.3 mm OD) and is disposed over a delivery device
50, for example a catheter. The delivery device 50 may include a
heat source 52. Any suitable heat source 52 may be used. In one
embodiment, the heat source 52 may comprise electrodes 56. A
conductive fluid, such as but not limited to saline (not shown),
may be heated from energy supplied to the electrodes 56, for
example by radio frequency (RF) energy (not shown). As depicted in
FIG. 15, the stent 10 is distensible to its expanded state, i.e.,
from a non-limiting dimension of about 20 Fr (or about 6.7 mm OD)
to a non-limiting dimension of about 30 Fr (or about 10 mm OD) or
larger to be disposed within a bodily lumen (not shown). In
general, a smaller delivery profile, e.g., contracted state, is
preferred. The delivery device 50 may be withdrawn leaving the
stent 10 behind and disposed within a bodily lumen (not shown). As
depicted in FIGS. 16 and 17, the delivery device 50' may further
include an expandable balloon 54. The use of the balloon 54 may aid
the expansion of the stent 10 by applying an expansive force or
pressure to the stent 10. Such expansive force may be used in
addition to the above-described expansion by the application of
heat. Further, the balloon 54 may also be filled with any suitable
fluid, for example the conductive fluid or saline to further aid in
the thermal expansion of the stent 10. The balloon 54 may be then
deflated, and the delivery device 50' may be withdrawn leaving the
stent 10 behind.
[0060] The stent 10 and the stent wall 12 may comprise radiopaque
materials, such as metallic-based powders or ceramic-based powders,
particulates or pastes which may be incorporated into the polymeric
material. For example, the radiopaque material may be blended with
the polymer composition from which the stent wall 12 is formed.
Various radiopaque materials and their salts and derivatives may be
used including, without limitation, bismuth, barium and its salts
such as barium sulfate, tantalum, tungsten, gold, platinum and
titanium, to name a few. Additional useful radiopaque materials may
be found in U.S. Pat. No. 6,626,936, which is herein incorporated
in its entirely by reference. Metallic complexes useful as
radiopaque materials are also contemplated. The stent 10 may be
selectively made radiopaque at desired areas along the stent or
made be fully radiopaque, depending on the desired end-product and
application. Alternatively, the stent 10 may also have improved
external imaging under magnetic resonance imaging (MRI) and/or
ultrasonic visualization techniques. MRI is produced by complex
interactions of magnetic and radio frequency fields. Materials for
enhancing MRI visibility include, but not be limited to, metal
particles of gadolinium, iron, cobalt, nickel, dysprosium,
dysprosium oxide, platinum, palladium, cobalt based alloys, iron
based alloys, stainless steels, or other paramagnetic or
ferromagnetic metals, gadolinium salts, gadolinium complexes,
gadopentetate dimeglumine, compounds of copper, nickel, manganese,
chromium, dysprosium and gadolinium. Moreover, the addition of
heat-conductive materials like metals may further aid in heating or
cooling the stent, including heating and/or cooling from an
external source. To enhance the visibility under ultrasonic
visualization the stent 10 of the present invention may include
ultrasound resonant material, such as but not limited to gold.
Other features, which may be included with the stent 10 of the
present invention, include radiopaque markers; surface modification
for ultrasound, therapeutic agent delivery; varying stiffness of
the stent or stent components; varying geometry, such as tapering,
flaring, bifurcation and the like; varying material; varying
geometry of stent components, for example tapered stent ends; and
the like.
[0061] The stent 10, 10', 10'' of the present invention, however,
is not limited to a tubular device having grooves on its external
wall surface. As depicted in FIG. 11, stent 10''' may be a
shape-memory polymeric stent having no or substantially no grooves
on its external wall surface 20.
[0062] In another embodiment of the present invention, a
stent-graft 60 is depicted in FIGS. 19 and 20. Stent graft 60 is a
hollow tubular device having opposed open ends 62, 64. A graft 68
is supported by stent members 66. The stent members 66 may include
any of the above-described shape memory polymeric materials. The
stent members 66 may include a plurality of spaced-apart members as
depicted in FIG. 20. As depicted in FIGS. 19 and 20, the stent
members 66 may be in the shape of a hollow cylindrical portion. The
present invention, however, is not so limited and other shape may
be suitably used. For example, the stent members 66 may be in the
shape of a ring or any other suitable shape or shapes. The graft 68
may also include any of the above-described shape memory polymeric
materials or may be a different material, such as silicone,
polyolefin or other polymeric material. The graft 68 may be secured
to the stent members 66 by any suitable means, such as by the use
of thermal, mechanical and/or chemical bonding.
[0063] Although the stent-graft 60 is depicted in FIGS. 19 and 20
as being fully covered by the graft 68, the present invention is
not so limited. The stent-graft 60 may be fully covered or
partially covered, i.e., having portions of the stent members 66
not covered by graft 68.
[0064] In further detail, suitable materials for the graft 68 may
include elastic or polymeric materials, including, silicone,
biodegradable materials, non-biodegradable materials, shape memory
materials. Further, the graft 68 may be a coating on the stent
members 66. The graft 68 may be may be in the form of a tubular
structure, for example composed of polymeric material and/or
silicone. The graft 68 may also comprise any plastic or polymeric
material, desirably a somewhat hard but flexible plastic or
polymeric material. The graft 68 may be transparent or translucent,
desirably substantially or partially transparent. Furthermore, the
graft 68 may be constructed of any suitable biocompatible
materials, such as, but not limited to, polymers and polymeric
materials, including fillers such as metals, carbon fibers, glass
fibers or ceramics. Useful covering and/or lining materials
include, but are not limited, polyethylene, polypropylene,
polyvinyl chloride, polytetrafluoroethylene, including expanded
polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene,
fluorinated ethylene propylene, polyvinyl acetate, polystyrene,
poly(ethylene terephthalate), naphthalene dicarboxylate
derivatives, such as polyethylene naphthalate, polybutylene
naphthalate, polytrimethylene naphthalate and trimethylenediol
naphthalate, polyurethane, polyurea, silicone rubbers, polyamides,
polyimides, polycarbonates, polyaldehydes, polyether ether ketone,
natural rubbers, polyester copolymers, silicone, styrene-butadiene
copolymers, polyethers, such as fully or partially halogenated
polyethers, and copolymers and combinations thereof
[0065] The stent members 66 may include any of the above-described
grooves or may be free of such grooves. Further, either or both of
the opposed ends 62, 64 may be flat or substantially flat as
depicted in FIG. 19. Alternatively, either of both of the opposed
ends 62, 64 may be rounded ends as described above.
[0066] FIGS. 21-22B depict additional embodiments of stent-graft 70
according to the present invention. As depicted in FIG. 21, stent
graft 70 is a hollow tubular device having opposed open ends 72,
74. The plurality of spaced apart stent members 76 may be embedded
in the graft 78 as depicted in FIG. 22A to so engage the spaced
apart stent members 76. Alternatively, the graft 78 may be disposed
between the spaced apart stent members 76 as depicted in FIG. 22B
to so engage the spaced apart stent members 76. The stent members
76 may include any of the above-described shape memory polymeric
materials and may include any of the above-described grooves or be
free of grooves. The graft 78 may also include any of the
above-described shape memory polymeric materials or above-described
graft materials. The graft 78 may also be secured to the stent
members 76 by any suitable means, such as by the use of thermal,
mechanical and/or chemical bonding. Although the stent-graft 70 is
depicted in FIGS. 21 and 22A as being fully covered by the graft
78, the present invention is not so limited. The stent-graft 70 may
be fully covered or partially covered, i.e., having portions of the
stent members 76 not covered by graft 78.
[0067] Stent-grafts of the present invention, however, are not
limited to a plurality of spaced apart stent members 66, 76. For
example, as depicted in FIG. 23, a slotted stent 86 of shape memory
polymeric materials may be used to support graft 88. The slotted
stent 86 depicted in FIG. 23 is in its radially expanded state
where the "slots" of the unexpanded stent have been altered to an
expanded "diamond" shape. The present invention is not limited to
the use of a slotted stent 86 and any suitable stent configuration
may be used. The slotted stent 86, or any suitable or similar stent
configuration, may include an open lattice wall structure as
depicted in FIG. 23. Included within the scope of an open lattice
wall structure are the spaced apart stent members 66, 76 of FIGS.
20, 22A and 22B.
[0068] Stent 10, 10', 10'', 10''' and/or stent-graft 60, 70, 80 may
be treated with a therapeutic agent or agents. "Therapeutic
agents", "pharmaceuticals," "pharmaceutically active agents",
"drugs" and other related terms may be used interchangeably herein
and include genetic therapeutic agents, non-genetic therapeutic
agents and cells. Therapeutic agents may be used singly or in
combination. A wide variety of therapeutic agents can be employed
in conjunction with the present invention including those used for
the treatment of a wide variety of diseases and conditions (i.e.,
the prevention of a disease or condition, the reduction or
elimination of symptoms associated with a disease or condition, or
the substantial or complete elimination of a disease or
condition).
[0069] Non-limiting examples of useful therapeutic agents include,
but are not limited to, adrenergic agents, adrenocortical steroids,
adrenocortical suppressants, alcohol deterrents, aldosterone
antagonists, amino acids and proteins, ammonia detoxicants,
anabolic agents, analeptic agents, analgesic agents, androgenic
agents, anesthetic agents, anorectic compounds, anorexic agents,
antagonists, anterior pituitary activators and suppressants,
anthelmintic agents, anti-adrenergic agents, anti-allergic agents,
anti-amebic agents, anti-androgen agents, anti-anemic agents,
anti-anginal agents, anti-anxiety agents, anti-arthritic agents,
anti-asthmatic agents, anti-atherosclerotic agents, antibacterial
agents, anticholelithic agents, anticholelithogenic agents,
anticholinergic agents, anticoagulants, anticoccidal agents,
anticonvulsants, antidepressants, antidiabetic agents,
antidiuretics, antidotes, antidyskinetics agents, anti-emetic
agents, anti-epileptic agents, anti-estrogen agents,
antifibrinolytic agents, antifungal agents, antiglaucoma agents,
antihemophilic agents, antihemophilic Factor, antihemorrhagic
agents, antihistaminic agents, antihyperlipidemic agents,
antihyperlipoproteinemic agents, antihypertensives,
antihypotensives, anti-infective agents, anti-inflammatory agents,
antikeratinizing agents, antimicrobial agents, antimigraine agents,
antimitotic agents, antimycotic agents, antineoplastic agents,
anti-cancer supplementary potentiating agents, antineutropenic
agents, antiobsessional agents, antiparasitic agents,
antiparkinsonian drugs, antipneumocystic agents, antiproliferative
agents, antiprostatic hypertrophy drugs, antiprotozoal agents,
antipruritics, antipsoriatic agents, antipsychotics, antirheumatic
agents, antischistosomal agents, antiseborrheic agents,
antispasmodic agents, antithrombotic agents, antitussive agents,
anti-ulcerative agents, anti-urolithic agents, antiviral agents,
benign prostatic hyperplasia therapy agents, blood glucose
regulators, bone resorption inhibitors, bronchodilators, carbonic
anhydrase inhibitors, cardiac depressants, cardioprotectants,
cardiotonic agents, cardiovascular agents, choleretic agents,
cholinergic agents, cholinergic agonists, cholinesterase
deactivators, coccidiostat agents, cognition adjuvants and
cognition enhancers, depressants, diagnostic aids, diuretics,
dopaminergic agents, ectoparasiticides, emetic agents, enzyme
inhibitors, estrogens, fibrinolytic agents, free oxygen radical
scavengers, gastrointestinal motility agents, glucocorticoids,
gonad-stimulating principles, hemostatic agents, histamine H2
receptor antagonists, hormones, hypocholesterolemic agents,
hypoglycemic agents, hypolipidemic agents, hypotensive agents,
HMGCoA reductase inhibitors, immunizing agents, immunomodulators,
immunoregulators, immunostimulants, immunosuppressants, impotence
therapy adjuncts, keratolytic agents, LHRH agonists, luteolysin
agents, mucolytics, mucosal protective agents, mydriatic agents,
nasal decongestants, neuroleptic agents, neuromuscular blocking
agents, neuroprotective agents, NMDA antagonists, non-hormonal
sterol derivatives, oxytocic agents, plasminogen activators,
platelet activating factor antagonists, platelet aggregation
inhibitors, post-stroke and post-head trauma treatments,
progestins, prostaglandins, prostate growth inhibitors,
prothyrotropin agents, psychotropic agents, radioactive agents,
repartitioning agents, scabicides, sclerosing agents, sedatives,
sedative-hypnotic agents, selective adenosine A1 antagonists,
adenosine A2 receptor antagonists (e.g., CGS 21680, regadenoson, UK
432097 or GW 328267), serotonin antagonists, serotonin inhibitors,
serotonin receptor antagonists, steroids, stimulants, thyroid
hormones, thyroid inhibitors, thyromimetic agents, tranquilizers,
unstable angina agents, uricosuric agents, vasoconstrictors,
vasodilators, vulnerary agents, wound healing agents, xanthine
oxidase inhibitors, and the like, and combinations thereof
[0070] Useful non-genetic therapeutic agents for use in connection
with the present invention include, but are not limited to, [0071]
(a) anti-thrombotic agents such as heparin, heparin derivatives,
urokinase, clopidogrel, and PPack (dextrophenylalanine proline
arginine chloromethylketone); [0072] (b) anti-inflammatory agents
such as dexamethasone, prednisolone, corticosterone, budesonide,
estrogen, sulfasalazine and mesalamine; [0073] (c)
antineoplastic/antiproliferative/anti-miotic agents such as
paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine,
epothilones, endostatin, angiostatin, angiopeptin, monoclonal
antibodies capable of blocking smooth muscle cell proliferation,
and thymidine kinase inhibitors; [0074] (d) anesthetic agents such
as lidocaine, bupivacaine and ropivacaine; [0075] (e)
anti-coagulants such as D-Phe-Pro-Arg chloromethyl ketone, an RGD
peptide-containing compound, heparin, hirudin, antithrombin
compounds, platelet receptor antagonists, anti-thrombin antibodies,
anti-platelet receptor antibodies, aspirin, prostaglandin
inhibitors, platelet inhibitors and tick antiplatelet peptides;
[0076] (f) vascular cell growth promoters such as growth factors,
transcriptional activators, and translational promotors; [0077] (g)
vascular cell growth inhibitors such as growth factor inhibitors,
growth factor receptor antagonists, transcriptional repressors,
translational repressors, replication inhibitors, inhibitory
antibodies, antibodies directed against growth factors,
bifunctional molecules consisting of a growth factor and a
cytotoxin, bifunctional molecules consisting of an antibody and a
cytotoxin; [0078] (h) protein kinase and tyrosine kinase inhibitors
(e.g., tyrphostins, genistein, quinoxalines); [0079] (i)
prostacyclin analogs; [0080] (j) cholesterol-lowering agents;
[0081] (k) angiopoietins; [0082] (l) antimicrobial agents such as
triclosan, cephalosporins, aminoglycosides and nitrofurantoin;
[0083] (m) cytotoxic agents, cytostatic agents and cell
proliferation affectors; [0084] (n) vasodilating agents; [0085] (o)
agents that interfere with endogenous vasoactive mechanisms; [0086]
(p) inhibitors of leukocyte recruitment, such as monoclonal
antibodies; [0087] (q) cytokines; [0088] (r) hormones; [0089] (s)
inhibitors of HSP 90 protein (i.e., Heat Shock Protein, which is a
molecular chaperone or housekeeping protein and is needed for the
stability and function of other client proteins/signal transduction
proteins responsible for growth and survival of cells) including
geldanamycin; [0090] (t) smooth muscle relaxants such as alpha
receptor antagonists (e.g., doxazosin, tamsulosin, terazosin,
prazosin and alfuzosin), calcium channel blockers (e.g., verapimil,
diltiazem, nifedipine, nicardipine, nimodipine and bepridil), beta
receptor agonists (e.g., dobutamine and salmeterol), beta receptor
antagonists (e.g., atenolol, metaprolol and butoxamine),
angiotensin-II receptor antagonists (e.g., losartan, valsartan,
irbesartan, candesartan, eprosartan and telmisartan), and
antispasmodic/anticholinergic drugs (e.g., oxybutynin chloride,
flavoxate, tolterodine, hyoscyamine sulfate, diclomine); [0091] (u)
bARKct inhibitors; [0092] (v) phospholamban inhibitors; [0093] (w)
Serca 2 gene/protein; [0094] (x) immune response modifiers
including aminoquizolines, for instance, imidazoquinolines such as
resiquimod and imiquimod; [0095] (y) human apolioproteins (e.g.,
AI, AII, AIII, AIV, AV, etc.); [0096] (z) selective estrogen
receptor modulators (SERMs) such as raloxifene, lasofoxifene,
arzoxifene, miproxifene, ospemifene, PKS 3741, MF 101 and SR 16234;
[0097] (aa) PPAR agonists, including PPAR-alpha, gamma and delta
agonists, such as rosiglitazone, pioglitazone, netoglitazone,
fenofibrate, bexaotene, metaglidasen, rivoglitazone and
tesaglitazar; [0098] (bb) prostaglandin E agonists, including PGE2
agonists, such as alprostadil or ONO 8815Ly; [0099] (cc) thrombin
receptor activating peptide (TRAP); [0100] (dd) vasopeptidase
inhibitors including benazepril, fosinopril, lisinopril, quinapril,
ramipril, imidapril, delapril, moexipril and spirapril; [0101] (ee)
thymosin beta 4; [0102] (ff) phospholipids including
phosphorylcholine, phosphatidylinositol and phosphatidylcholine;
and [0103] (gg) VLA-4 antagonists and VCAM-1 antagonists.
[0104] The non-genetic therapeutic agents may be used individually
or in combination, including in combination with any of the agents
described herein.
[0105] Further examples of non-genetic therapeutic agents, not
necessarily exclusive of those listed above, include taxanes such
as paclitaxel (including particulate forms thereof, for instance,
protein-bound paclitaxel particles such as albumin-bound paclitaxel
nanoparticles, e.g., ABRAXANE), sirolimus, everolimus, tacrolimus,
zotarolimus, Epo D, dexamethasone, estradiol, halofuginone,
cilostazole, geldanamycin, alagebrium chloride (ALT-711), ABT-578
(Abbott Laboratories), trapidil, liprostin, Actinomcin D,
Resten-NG, Ap-17, abciximab, clopidogrel, Ridogrel, beta-blockers,
bARKct inhibitors, phospholamban inhibitors, Serca 2 gene/protein,
imiquimod, human apolioproteins (e.g., AI-AV), growth factors
(e.g., VEGF-2), as well derivatives of the forgoing, among
others.
[0106] Useful genetic therapeutic agents for use in connection with
the present invention include, but are not limited to, anti-sense
DNA and RNA as well as DNA coding for the various proteins (as well
as the proteins themselves), such as (a) anti-sense RNA; (b) tRNA
or rRNA to replace defective or deficient endogenous molecules; (c)
angiogenic and other factors including growth factors such as
acidic and basic fibroblast growth factors, vascular endothelial
growth factor, endothelial mitogenic growth factors, epidermal
growth factor, transforming growth factor .alpha. and .beta.,
platelet-derived endothelial growth factor, platelet-derived growth
factor, tumor necrosis factor .alpha., hepatocyte growth factor and
insulin-like growth factor; (d) cell cycle inhibitors including CD
inhibitors, and (e) thymidine kinase ("TK") and other agents useful
for interfering with cell proliferation. DNA encoding for the
family of bone morphogenic proteins ("BMP's") are also useful and
include, but not limited to, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6
(Vgr-1), BMP-7 (OP-1), BMP-8, BMP-9, BMP-10, BMP-11, BMP-12,
BMP-13, BMP-14, BMP-15, and BMP-16. Currently desirably BMP's are
any of BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 and BMP-7. These dimeric
proteins can be provided as homodimers, heterodimers, or
combinations thereof, alone or together with other molecules.
Alternatively, or in addition, molecules capable of inducing an
upstream or downstream effect of a BMP can be provided. Such
molecules include any of the "hedgehog" proteins, or the DNA's
encoding them.
[0107] Vectors for delivery of genetic therapeutic agents include,
but not limited to, viral vectors such as adenoviruses, gutted
adenoviruses, adeno-associated virus, retroviruses, alpha virus
(Semliki Forest, Sindbis, etc.), lentiviruses, herpes simplex
virus, replication competent viruses (e.g., ONYX-015) and hybrid
vectors; and non-viral vectors such as artificial chromosomes and
mini-chromosomes, plasmid DNA vectors (e.g., pCOR), cationic
polymers (e.g., polyethyleneimine, polyethyleneimine (PEI)), graft
copolymers (e.g., polyether-PEI and polyethylene oxide-PEI),
neutral polymers such as polyvinylpyrrolidone (PVP), SP1017
(SUPRATEK), lipids such as cationic lipids, liposomes, lipoplexes,
nanoparticles, or microparticles, with and without targeting
sequences such as the protein transduction domain (PTD).
[0108] Cells for use in connection with the present invention may
include cells of human origin (autologous or allogeneic), including
whole bone marrow, bone marrow derived mono-nuclear cells,
progenitor cells (e.g., endothelial progenitor cells), stem cells
(e.g., mesenchymal, hematopoietic, neuronal), pluripotent stem
cells, fibroblasts, myoblasts, satellite cells, pericytes,
cardiomyocytes, skeletal myocytes or macrophage, or from an animal,
bacterial or fungal source (xenogeneic), which can be genetically
engineered, if desired, to deliver proteins of interest.
[0109] Numerous therapeutic agents, not necessarily exclusive of
those listed above, have been identified as candidates for vascular
treatment regimens, for example, as agents targeting restenosis
(antirestenotics). Such agents are useful for the practice of the
present invention and include one or more of the following: [0110]
(a) Ca-channel blockers including benzothiazapines such as
diltiazem and clentiazem, dihydropyridines such as nifedipine,
amlodipine and nicardapine, and phenylalkylamines such as
verapamil; [0111] (b) serotonin pathway modulators including: 5-HT
antagonists such as ketanserin and naftidrofuryl, as well as 5-HT
uptake inhibitors such as fluoxetine; [0112] (c) cyclic nucleotide
pathway agents including phosphodiesterase inhibitors such as
cilostazole and dipyridamole, adenylate/Guanylate cyclase
stimulants such as forskolin, as well as adenosine analogs; [0113]
(d) catecholamine modulators including .alpha.-antagonists such as
prazosin and bunazosine, .beta.-antagonists such as propranolol and
.alpha./.beta.-antagonists such as labetalol and carvedilol; [0114]
(e) endothelin receptor antagonists such as bosentan, sitaxsentan
sodium, atrasentan, endonentan; [0115] (f) nitric oxide
donors/releasing molecules including organic nitrates/nitrites such
as nitroglycerin, isosorbide dinitrate and amyl nitrite, inorganic
nitroso compounds such as sodium nitroprusside, sydnonimines such
as molsidomine and linsidomine, nonoates such as diazenium diolates
and NO adducts of alkanediamines, S-nitroso compounds including low
molecular weight compounds (e.g., S-nitroso derivatives of
captopril, glutathione and N-acetyl penicillamine) and high
molecular weight compounds (e.g., S-nitroso derivatives of
proteins, peptides, oligosaccharides, polysaccharides, synthetic
polymers/oligomers and natural polymers/oligomers), as well as
C-nitroso-compounds, O-nitroso-compounds, N-nitroso-compounds and
L-arginine; [0116] (g) Angiotensin Converting Enzyme (ACE)
inhibitors such as cilazapril, fosinopril and enalapril; [0117] (h)
ATII-receptor antagonists such as saralasin and losartin; [0118]
(i) platelet adhesion inhibitors such as albumin and polyethylene
oxide; [0119] (j) platelet aggregation inhibitors including
cilostazole, aspirin and thienopyridine (ticlopidine, clopidogrel)
and GP IIb/IIIa inhibitors such as abciximab, epitifibatide and
tirofiban; [0120] (k) coagulation pathway modulators including
heparinoids such as heparin, low molecular weight heparin, dextran
sulfate and .beta.-cyclodextrin tetradecasulfate, thrombin
inhibitors such as hirudin, hirulog,
PPACK(D-phe-L-propyl-L-arg-chloromethylketone) and argatroban, FXa
inhibitors such as antistatin and TAP (tick anticoagulant peptide),
Vitamin K inhibitors such as warfarin, as well as activated protein
C; [0121] (l) cyclooxygenase pathway inhibitors such as aspirin,
ibuprofen, flurbiprofen, indomethacin and sulfinpyrazone; [0122]
(m) natural and synthetic corticosteroids such as dexamethasone,
prednisolone, methprednisolone and hydrocortisone; [0123] (n)
lipoxygenase pathway inhibitors such as nordihydroguairetic acid
and caffeic acid; [0124] (o) leukotriene receptor antagonists; (p)
antagonists of E- and P-selectins; [0125] (q) inhibitors of VCAM-1
and ICAM-1 interactions; [0126] (r) prostaglandins and analogs
thereof including prostaglandins such as PGE1 and PGI2 and
prostacyclin analogs such as ciprostene, epoprostenol, carbacyclin,
iloprost and beraprost; [0127] (s) macrophage activation preventers
including bisphosphonates; [0128] (t) HMG-CoA reductase inhibitors
such as lovastatin, pravastatin, atorvastatin, fluvastatin,
simvastatin and cerivastatin; [0129] (u) fish oils and
omega-3-fatty acids; [0130] (v) free-radical
scavengers/antioxidants such as probucol, vitamins C and E,
ebselen, trans-retinoic acid, SOD (orgotein) and SOD mimics,
verteporfin, rostaporfin, AGI 1067, and M 40419; [0131] (w) agents
affecting various growth factors including FGF pathway agents such
as bFGF antibodies and chimeric fusion proteins, PDGF receptor
antagonists such as trapidil, IGF pathway agents including
somatostatin analogs such as angiopeptin and ocreotide, TGF-.beta.
pathway agents such as polyanionic agents (heparin, fucoidin),
decorin, and TGF-.beta. antibodies, EGF pathway agents such as EGF
antibodies, receptor antagonists and chimeric fusion proteins,
TNF-.alpha. pathway agents such as thalidomide and analogs thereof,
Thromboxane A2 (TXA2) pathway modulators such as sulotroban,
vapiprost, dazoxiben and ridogrel, as well as protein tyrosine
kinase inhibitors such as tyrphostin, genistein and quinoxaline
derivatives; [0132] (x) matrix metalloprotease (MMP) pathway
inhibitors such as marimastat, ilomastat, metastat, batimastat,
pentosan polysulfate, rebimastat, incyclinide, apratastat, PG
116800, RO 1130830 or ABT 518; [0133] (y) cell motility inhibitors
such as cytochalasin B; [0134] (z) antiproliferative/antineoplastic
agents including antimetabolites such as purine antagonists/analogs
(e.g., 6-mercaptopurine and pro-drugs of 6-mercaptopurine such as
azathioprine or cladribine, which is a chlorinated purine
nucleoside analog), pyrimidine analogs (e.g., cytarabine and
5-fluorouracil) and methotrexate, nitrogen mustards, alkyl
sulfonates, ethylenimines, antibiotics (e.g., daunorubicin,
doxorubicin), nitrosoureas, cisplatin, agents affecting microtubule
dynamics (e.g., vinblastine, vincristine, colchicine, Epo D,
paclitaxel and epothilone), caspase activators, proteasome
inhibitors, angiogenesis inhibitors (e.g., endostatin, angiostatin
and squalamine), olimus family drugs (e.g., sirolimus, everolimus,
tacrolimus, zotarolimus, etc.), cerivastatin, flavopiridol and
suramin; [0135] (aa) matrix deposition/organization pathway
inhibitors such as halofuginone or other quinazolinone derivatives,
pirfenidone and tranilast; [0136] (bb) endothelialization
facilitators such as VEGF and RGD peptide; [0137] (cc) blood
rheology modulators such as pentoxifylline and [0138] (dd) glucose
cross-link breakers such as alagebrium chloride (ALT-711).
[0139] These therapeutic agents may be used individually or in
combination, including in combination with any of the agents
described herein.
[0140] Numerous additional therapeutic agents useful for the
practice of the present invention are also disclosed in U.S. Pat.
No. 5,733,925 to Kunz, the contents of which is incorporated herein
by reference.
[0141] A wide range of therapeutic agent loadings may used in
connection with the dosage forms of the present invention, with the
pharmaceutically effective amount being readily determined by those
of ordinary skill in the art and ultimately depending, for example,
upon the condition to be treated, the nature of the therapeutic
agent itself, the tissue into which the dosage form is introduced,
and so forth. The stent 10, 10', 10'', 10''' may include coatings,
linings, layers, laminates, agent delivery particles, reinforcement
particles, reinforcement strands.
[0142] The following embodiments or aspects of the invention may be
combined in any fashion and combination and be within the scope of
the present invention, as follows: [0143] Embodiment 1: An
implantable, radially distensible device comprising: a tubular
structure having an open first end and an opposed open second end,
the tubular structure having a wall between said first open end and
said second end to define an open lumen therethrough, the wall
having an outer surface and an opposed inner surface defining a
wall thickness therebetween; the wall comprising a shape memory
polymeric material; wherein the tubular structure is a
self-supporting wall structure. [0144] Embodiment 2: The device of
embodiment 1, wherein the tubular structure has a substantially
solid wall and has a plurality of grooves disposed within the outer
surface of said wall. [0145] Embodiment 3: The device of embodiment
1, wherein the device is radially distensible between a radially
contracted state and a radially expanded state. [0146] Embodiment
4: The device of embodiment 1, wherein the self-supporting wall
structure does not have an open lattice wall structure. [0147]
Embodiment 5: The device of embodiment 1, wherein the
self-supporting wall structure is a substantially solid wall
without gaps in a radially expanded state. [0148] Embodiment 6: The
device of embodiment 2, wherein the grooves are present in the wall
when the device is in a radially expanded state. [0149] Embodiment
7: The device of embodiment 2, wherein the grooves are present in
the wall when the device is in a radially contracted state and in a
radially expanded state. [0150] Embodiment 8: The device of
embodiment 2, wherein the grooves are selected from the group
consisting of a semicircular groove, a truncated circular groove, a
semicircular groove with rounded surfaces, a groove having a flat
bottom portion and smoothly rounded sides, a triangular-shaped
groove, a groove having a flat bottom portion and sloped sides, a
square-shaped groove, a rectangular-shaped groove, and combinations
thereof. [0151] Embodiment 9: The device of embodiment 2, wherein
the grooves are a plurality of radially orientated grooves. [0152]
Embodiment 10: The device of embodiment 2, wherein the grooves are
a plurality of helically orientated grooves. [0153] Embodiment 11:
The device of embodiment 2, wherein the grooves are a plurality of
interconnected helically orientated grooves having a first helical
pattern and a second helical pattern. [0154] Embodiment 12: The
device of embodiment 11, wherein the grooves are crisscrossed
helical grooves. [0155] Embodiment 13: The device of embodiment 2,
wherein the grooves are interconnected grooves. [0156] Embodiment
14: The device of embodiment 1, wherein the shape memory polymeric
material of the wall of the device comprises shape memory polymeric
polycyclooctene. [0157] Embodiment 15: The device of embodiment 1,
wherein the shape memory polymeric material of the wall of the
device further includes a radiopaque material. [0158] Embodiment
16: The device of embodiment 1, wherein the shape memory polymeric
material is biodegradable. [0159] Embodiment 17: The device of
embodiment 1, wherein the wall thickness is from about 0.038 cm to
about 0.635 cm. [0160] Embodiment 18: The device of embodiment 2,
wherein the grooves comprise a depth and wherein the depth the
grooves are from about 5% to about 50% of the wall thickness.
[0161] Embodiment 19: The device of embodiment 1, wherein device
comprises a longitudinal length between the first open end and the
second open end and wherein the longitudinal length of the device
is from about 1 cm to about 15 cm. [0162] Embodiment 20: The device
of embodiment 2, wherein device comprises a longitudinal length
between the first open end and the second open end and wherein
adjacently juxtaposed grooves are disposed at a distance from about
0.25 cm to about 3 cm from one and the other along the longitudinal
length of the device. [0163] Embodiment 21: The device of
embodiment 1, wherein device is a stent. [0164] Embodiment 22: The
device of embodiment 1, further comprising: at least two tubular
structures and a graft disposed over the at least two tubular
structures, wherein the at least two tubular structures are spaced
apart from one and the other. [0165] Embodiment 23: The device of
embodiment 1, further comprising: at least two tubular structures
and a graft disposed between the at least two tubular structures,
wherein the at least two tubular structures are spaced apart from
one and the other. [0166] Embodiment 24: The device of embodiment
1, further comprising: at least two tubular structures and a graft;
wherein the at least two tubular structures are embedded in the
graft and, wherein the at least two tubular structures are spaced
apart from one and the other. [0167] Embodiment 25: The device of
embodiment 1, wherein the tubular structure is an open lattice wall
structure. [0168] Embodiment 26: The device of embodiment 25,
further comprising tubular structure further comprising a graft
disposed over the open lattice wall structure. [0169] Embodiment
27: The device of embodiment 25, wherein the open lattice wall
structure is a stent. [0170] Embodiment 28: A method of making a
stent, comprising: providing a shape memory polymer; forming the
shape memory polymer into a tubular structure having an open first
end and an opposed open second end, the tubular structure having a
wall between said first open end and said second end to define an
open lumen therethrough, the wall having an outer surface and an
opposed inner surface defining a wall thickness therebetween.
[0171] Embodiment 29: The method of embodiment 28, further
comprising: disposing grooves within the outer surface of the wall.
[0172] Embodiment 30: The method of embodiment 28, wherein the step
of providing the shape memory polymer further comprises providing
shape memory polymeric polycyclooctene. [0173] Embodiment 31: The
method of embodiment 28, wherein the step of forming the shape
memory polymer into the tubular structure further comprises molding
the shape memory polymer. [0174] Embodiment 32: The method of
embodiment 28, wherein the step of forming the shape memory polymer
into the tubular structure further comprises casting the shape
memory polymer. [0175] Embodiment 33: The method of embodiment 28,
wherein the step of forming the shape memory polymer into the
tubular structure further comprises extruding the shape memory
polymer. [0176] Embodiment 34: The method of embodiment 29, wherein
the step of disposing grooves within the outer surface of the wall
further comprises mechanically forming the grooves. [0177]
Embodiment 35: The method of embodiment 34, wherein the step of
mechanically forming the grooves further comprises milling the
outer surface of the wall, grinding the outer surface of the wall,
cutting the outer surface of the wall, laser cutting the outer
surface of the wall, etching the outer surface of the wall, masking
the outer surface of the wall, or removal of a sacrificial layer or
filament from the outer surface of the wall to form the grooves.
[0178] Embodiment 36: The method of embodiment 31, further
comprising molding the grooves within the outer surface of the
wall. [0179] Embodiment 37: An assembly for intraluminal delivery
of a stent, comprising: a delivery device having an elongate tube;
and a radially distensible stent comprising: a tubular structure
having an open first end and an opposed open second end, the
tubular structure having a wall between said first open end and
said second end to define an open lumen therethrough, the wall
having an outer surface and an opposed inner surface defining a
wall thickness therebetween; the wall comprising a shape memory
polymeric material; and grooves disposed within the outer surface
of said wall; wherein the stent is disposed in a contracted state
on the elongate tube of the delivery device. [0180] Embodiment 38:
The assembly of embodiment 37, wherein the delivery device further
comprises an expandable member. [0181] Embodiment 39: The assembly
of embodiment 37, wherein the delivery device further comprises a
heat source. [0182] Embodiment 40: A method for intraluminal
delivery of a stent, comprising providing an assembly, comprising:
a delivery device having an elongate tube; and a radially
distensible stent comprising: a tubular structure having an open
first end and an opposed open second end, the tubular structure
having a wall between said first open end and said second end to
define an open lumen therethrough, the wall having an outer surface
and an opposed inner surface defining a wall thickness
therebetween; the wall comprising a shape memory polymeric
material; and grooves disposed within the outer surface of said
wall; wherein the stent is disposed in a contracted state on the
elongate tube of the delivery device; advancing the assembly to a
site within a bodily lumen; radially expanding the stent within the
bodily lumen; and withdrawing the delivery device to leave the
stent within the bodily lumen. [0183] Embodiment 41: The method of
embodiment 40, wherein the step of radially expanding the stent
within the bodily lumen further comprises supplying heat from a
heat source to the stent to radially expand the stent. [0184]
Embodiment 42: The method of embodiment 40, wherein the step of
radially expanding the stent within the bodily lumen further
comprises providing an expandable member to mechanically radially
expand the stent. [0185] Embodiment 43: The method of embodiment
41, further comprising: providing an expandable member to
mechanically expand the stent. [0186] Embodiment 44: Use of the
device of embodiments 1-27. [0187] Embodiment 45: A stent made by
the method of embodiment 28-36. [0188] Embodiment 46: Use of the
assembly of embodiments 37-39.
[0189] While various embodiments of the present invention are
specifically illustrated and/or described herein, it will be
appreciated that modifications and variations of the present
invention may be effected by those skilled in the art without
departing from the spirit and intended scope of the invention.
Further, any of the embodiments or aspects of the invention as
described in the claims or throughout the specification may be used
with one and another without limitation.
* * * * *