U.S. patent application number 12/623921 was filed with the patent office on 2010-03-18 for biodegradable connectors.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. Invention is credited to John Blix, Thomas E. Broome, Daniel Gregorich, Adam Jennings, Gordon J. Kocur, Michael P. Meyer.
Application Number | 20100070023 12/623921 |
Document ID | / |
Family ID | 39676523 |
Filed Date | 2010-03-18 |
United States Patent
Application |
20100070023 |
Kind Code |
A1 |
Broome; Thomas E. ; et
al. |
March 18, 2010 |
BIODEGRADABLE CONNECTORS
Abstract
An expandable bifurcated stent is formed of a main body and a
first branch. The body wall is made up of interconnected stent
members that define a plurality of cells, at least one of which is
a side opening. The first branch body extends from the body wall
from at least two regions adjacent the side opening. At least one
stent member adjacent the perimeter is bioabsorbable.
Inventors: |
Broome; Thomas E.; (Prior
Lake, MN) ; Gregorich; Daniel; (St. Louis Park,
MN) ; Jennings; Adam; (Buffalo, MN) ; Meyer;
Michael P.; (Richfield, MN) ; Blix; John;
(Maple Grove, MN) ; Kocur; Gordon J.; (Lino Lakes,
MN) |
Correspondence
Address: |
VIDAS, ARRETT & STEINKRAUS, P.A.
SUITE 400, 6640 SHADY OAK ROAD
EDEN PRAIRIE
MN
55344
US
|
Assignee: |
Boston Scientific Scimed,
Inc.
Maple Grove
MN
|
Family ID: |
39676523 |
Appl. No.: |
12/623921 |
Filed: |
November 23, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11773991 |
Jul 6, 2007 |
7632305 |
|
|
12623921 |
|
|
|
|
Current U.S.
Class: |
623/1.16 ;
623/1.35 |
Current CPC
Class: |
A61F 2250/003 20130101;
A61F 2250/0071 20130101; A61F 2/915 20130101; A61F 2002/91583
20130101; A61F 2230/0054 20130101; A61F 2002/821 20130101; A61F
2/856 20130101; A61F 2250/0031 20130101; A61F 2/91 20130101; A61F
2250/006 20130101; A61F 2002/91558 20130101 |
Class at
Publication: |
623/1.16 ;
623/1.35 |
International
Class: |
A61F 2/82 20060101
A61F002/82 |
Claims
1. A bifurcated stent comprising: a plurality of interconnected
stent members defining a side branch opening, the side branch
opening having a perimeter and a plurality of deflectable members,
the deflectable members having a first end and a second end, the
first end engaged to the perimeter, the second end extending into
the side branch opening, wherein at least two of the plurality of
deflectable members are connected to one another via at least one
bioabsorbable stent member.
2. The bifurcated stent of claim 1, wherein the at least one
bioabsorbable stent member is curved.
3. The bifurcated stent of claim 1 further comprising a main body
portion, an unexpanded configuration, and an expanded
configuration; the main body portion further comprising an outer
surface; wherein, in the unexpanded configuration, the deflectable
members are coplanar with the outer surface of the main body
portion, and, in the expanded configuration, the deflectable
members extend outwardly from the outer surface of the main body
portion.
4. The bifurcated stent of claim 1, wherein each of the deflectable
members comprises a side branch petal.
5. The bifurcated stent of claim 1, wherein the at least one
bioabsorbable stent member comprises a material selected from the
group consisting of: poly(hydroxyvalerate), poly(L-lactic acid),
polycaprolactone, poly(lactide-co-glycolide),
poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate),
polydioxanone, polyorthoesters, polyanhydrides, poly(glycolic
acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene
carbonate), polyphosphoesters, polyphosphoester urethanes,
poly(amino acids), cyanoacrylates, poly(trimethylene carbonate),
poly(iminocarbonate), copoly(ether-esters), polyalkylene oxalates,
polyphosphazenes, fibrin, fibrinogen, cellulose, starch, collagen,
hyaluronic acid, and combinations thereof.
6. The bifurcated stent of claim 1, wherein the at least one
bioabsorbable stent member extends from the second end of one of
the plurality of deflectable members to the second end of another
of the plurality of deflectable members.
7. The bifurcated stent of claim 1, wherein at least a portion of
the perimeter is bioabsorbable.
8. The bifurcated stent of claim 1, wherein the at least one
bioabsorbable stent member comprises a plurality of bioabsorbable
stent members, the plurality of bioabsorbable stent members being
concentric with the perimeter of the branch opening.
9. A bifurcated stent comprising: an unexpanded configuration and
an expanded configuration; a plurality of interconnected stent
members defining a plurality of cells, at least one of the
plurality of cells comprising a side opening, the side opening
being shaped differently than the other cells, the side opening
having a perimeter; and a plurality of side branch petals extending
from the perimeter into the side opening; in an unexpanded
configuration, the side branch petals being connected one to
another by at least one bioabsorbable stent member.
10. The bifurcated stent of claim 9, wherein, in an expanded
configuration, the at least one bioabsorbable stent member is no
longer connecting the side branch petals.
11. The bifurcated stent of claim 9, wherein the perimeter of the
side opening is circular.
12. The bifurcated stent of claim 11, wherein the at least one
bioabsorbable stent member is concentric with the perimeter.
13. The bifurcated stent of claim 9, wherein at least a portion of
the perimeter is bioabsorbable.
14. The bifurcated stent of claim 13 further comprising a main
stent body, wherein, in an unexpanded configuration, the side
branch petals are connected to the main stent body and, in an
expanded configuration, the side branch petals are disconnected
from the main stent body.
15. The bifurcated stent of claim 14, wherein each of the plurality
of side branch petals comprises a second end, the at least one
bioabsorbable stent member extending from the second end of one of
the plurality of side branch petals to the second end of another of
the plurality side branch petals.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 11/773,991, filed on Jul. 6, 2007.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
[0002] Not Applicable
BACKGROUND OF THE INVENTION
[0003] Stents and similar devices such as stent, stent-grafts,
expandable frameworks, and similar implantable medical devices, are
radially expandable endoprostheses which are typically
intravascular implants capable of being implanted transluminally
and enlarged radially after being introduced percutaneously. Stents
may be implanted in a variety of body lumens or vessels such as
within the vascular system, urinary tracts, bile ducts, fallopian
tubes, coronary vessels, secondary vessels, etc. They may be
self-expanding, expanded by an internal radial force, such as when
mounted on a balloon, or a combination of self-expanding and
balloon expandable (hybrid expandable).
[0004] Stents may be created by methods including cutting or
etching a design from a tubular stock, from a flat sheet which is
cut or etched and which is subsequently rolled or from one or more
interwoven wires or braids.
[0005] Within the vasculature it is not uncommon for stenoses to
form at a vessel bifurcation. A bifurcation is an area of the
vasculature or other portion of the body where a first (or parent)
vessel is bifurcated into two or more branch vessels. Where a
stenotic lesion or lesions form at such a bifurcation, the
lesion(s) can affect only one of the vessels (i.e., either of the
branch vessels or the parent vessel) two of the vessels, or all
three vessels.
[0006] The art referred to and/or described above is not intended
to constitute an admission that any patent, publication or other
information referred to herein is "prior art" with respect to this
invention. In addition, this section should not be construed to
mean that a search has been made or that no other pertinent
information as defined in 37 C.F.R. .sctn.1.56(a) exists.
[0007] All U.S. patents and applications and all other published
documents mentioned anywhere in this application are incorporated
herein by reference in their entirety.
[0008] Without limiting the scope of the invention a brief summary
of some of the claimed embodiments of the invention is set forth
below. Additional details of the summarized embodiments of the
invention and/or additional embodiments of the invention may be
found in the Detailed Description of the Invention below.
[0009] A brief abstract of the technical disclosure in the
specification is provided as well only for the purposes of
complying with 37 C.F.R. 1.72. The abstract is not intended to be
used for interpreting the scope of the claims.
BRIEF SUMMARY
[0010] Embodiments of the invention are directed to a bifurcated
stent having an unexpanded state and an expanded state. The stent
comprises a main body with a body wall. The body wall extends along
a main longitudinal axis from a proximal end to a distal end and
defines a lumen between the two ends. The body wall is comprised of
interconnected stent members, a plurality of which defines a
plurality of cells. At least one of the cells is a side opening
having a perimeter. The side opening is shaped differently then the
other cells of the stent.
[0011] The stent also comprises a first branch having a first
branch body. The first branch body is positioned between the distal
end and the proximal end of the main body and extends along a first
branch longitudinal axis when the stent is in the expanded state.
Furthermore, the first branch body extends from the body wall from
at least a first region adjacent the side opening and a second
region adjacent the side opening. At least one of the stent members
adjacent the perimeter is bioabsorbable.
[0012] In some embodiments, the stent includes deflectable members
which extend from the main body at positions about the perimeter of
the side opening.
[0013] In at least one embodiment, the side opening perimeter
includes a bioabsorbable expansion joint.
[0014] In at least one embodiment, the body wall comprises a
plurality of circumferential rings, longitudinally offset from one
another about the main longitudinal axis. The first branch body
also comprises at least one branch ring being arranged about the
first branch axis and extending from the perimeter of the side
opening by at least one bioabsorbable stent member.
[0015] These and other embodiments which characterize the invention
are pointed out with particularity in the claims annexed hereto and
forming a part hereof. However, for further understanding of the
invention, its advantages and objectives obtained by its use,
reference should be made to the drawings which form a further part
hereof and the accompanying descriptive matter, in which there is
illustrated and described embodiments of the invention.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0016] A detailed description of the invention is hereafter
described with specific reference being made to the drawings.
[0017] FIG. 1a is a side view of an embodiment of the present
bifurcated stent.
[0018] FIG. 1b is a cross-sectional view of the embodiment depicted
in FIG. 1a.
[0019] FIG. 2a is a perspective view of an embodiment of the
inventive stent, with the deflectable members connected by
bioabsorbable stent members.
[0020] FIG. 2b is a perspective view of the embodiment shown in
FIG. 2a, after the bioabsorbable stent members have degraded.
[0021] FIG. 3a is a flat layout of an embodiment of the inventive
stent, with bioabsorbable expansion joints.
[0022] FIG. 3b is a flat layout of the embodiment depicted in FIG.
3a, after the bioabsorbable expansion joint has degraded.
[0023] FIG. 4a is a side view of an embodiment of the inventive
stent, with circumferential rings in the main body and branch rings
in the branch body.
[0024] FIG. 4b is a side view of the embodiment depicted in FIG.
4a, after the bioabsorbable stent members have degraded.
[0025] FIG. 4c is a side view of the embodiment depicted in FIG.
4a, after the bioabsorbable stent members have degraded.
[0026] FIG. 4d is a side view of the embodiment depicted in FIG.
4a, after the bioabsorbable stent members have degraded.
[0027] FIG. 5a is a perspective view of an embodiment of the
inventive stent, with the deflectable members extending from a
bioabsorbable perimeter.
[0028] FIG. 5b is a perspective view of the embodiment shown in
FIG. 5a, after the bioabsorbable perimeter has degraded.
[0029] FIG. 6a is a flat layout of an embodiment of the inventive
stent, with circumferential rings adjacent the side opening engaged
to the side opening by bioabsorbable stent members.
[0030] FIG. 6b is a flat layout of the embodiment depicted in FIG.
6a with deflectable members.
[0031] FIG. 7a is a flat layout of an embodiment of the inventive
stent, with a bioabsorbable stent member substantially covering the
side opening.
[0032] FIG. 7b is a flat layout of an embodiment of the inventive
stent, with a plurality of bioabsorbable stent members
substantially covering the side opening.
[0033] FIG. 8a is a side view of an embodiment of the inventive
stent, with two branches extending from the distal end of the main
body by bioabsorbable stent members.
[0034] FIG. 8b is a side view of the embodiment depicted in FIG.
8a, after the bioabsorbable stent members have degraded.
[0035] FIG. 9 is a flat layout of an embodiment of the inventive
stent, with a bioabsorbable perimeter.
DETAILED DESCRIPTION OF THE INVENTION
[0036] While this invention may be embodied in many different
forms, there are described in detail herein specific preferred
embodiments of the invention. This description is an
exemplification of the principles of the invention and is not
intended to limit the invention to the particular embodiments
illustrated.
[0037] For the purposes of this disclosure, like reference numerals
in the figures shall refer to like features unless otherwise
indicated.
[0038] FIG. 1a depicts an embodiment of the invention, which
includes a bifurcated stent with bioabsorbable members, wherein the
stent 12 is shown in an expanded state.
[0039] In embodiments of the invention bioabsorbable members are
constructed from one or more metals, polymers or combinations
thereof that are corrodible so as to dissolve, dissociate or
otherwise break down in the body without ill effect. Examples of
such materials have been referred to as being degradable,
biodegradable, biologically degradable, erodable, bioabsorbable,
bioresorbable, and the like, and are herein collectively referred
to as being bioabsorbable materials.
[0040] Examples of bioabsorbable materials include, but are not
limited to, poly(hydroxyvalerate), poly(L-lactic acid),
polycaprolactone, poly(lactide-co-glycolide),
poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate),
polydioxanone, polyorthoesters, polyanhydrides, poly(glycolic
acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene
carbonate), polyphosphoesters, polyphosphoester urethanes,
poly(amino acids), cyanoacrylates, poly(trimethylene carbonate),
poly(iminocarbonate), copoly(ether-esters) (e.g. PEO/PLA),
polyalkylene oxalates, polyphosphazenes and biomolecules such as
fibrin, fibrinogen, cellulose, starch, collagen, hyaluronic acid,
etc., and mixtures thereof. Further examples of bioabsorbable
materials may be found in U.S. Pat. Nos. 6,258,117, 6,409,754, and
7,022,132 and in U.S. Patent Application Publication No.
2002/0107560, the entire contents of which are incorporated herein
by reference.
[0041] As stated above, the stent comprises a main body 15 and a
first branch 20. The main body 15 comprises a body wall 25 made up
of interconnected stent members 30. As seen in FIG. 1a, the body
wall 25 extends along a main longitudinal axis 35 from a proximal
end 40 of the main body to a distal end 45 of the main body,
defining a lumen 50 therethrough.
[0042] Regarding the interconnected stent members 30, the stent
members 30 include struts, connectors, sutures, expansion joints,
combinations thereof, or any number of other structures suitable
for use in constructing a stent. A plurality of the interconnected
stent members 30 define a plurality of cells 55. At least one of
the cells 55 is a side opening 60. The side opening 60 is
distinguishable because it is shaped differently then the other
cells of the stent. In some embodiments, the side opening 60 is
larger than the other cells. Additionally, the side opening 60 has
a perimeter 65. One of ordinary skill in the art will recognize
that the perimeter 65 can be any number of shapes and is not
limited to circular, elliptical, or any of the shapes specifically
depicted in the drawings.
[0043] In addition to the main body, the stent further comprises a
first branch 20 with a first branch body 75, as depicted in the
embodiment shown in FIG. 1a. The first branch body 75 is positioned
between the proximal end 40 and the distal end 45 of the main body
15. The first branch body 75 extends along a first branch
longitudinal axis 80 when the stent is in the expanded state. As
seen in FIG. 1a, the first branch body 75 extends from the body
wall 25 from at least a first region 85 adjacent the side opening
60 and a second region 90 adjacent the side opening 60. At least
one stent member adjacent the perimeter 65 is bioabsorbable. One or
more bioabsorbable stent member(s) 70 is/are positioned anywhere on
or within the structure of the stent 12. An example of embodiments
including at least one bioabsorbable stent member 70, and the
position of the member are shown in both FIG. 1a and in
cross-sectional view FIG. 1b. The bioabsorbable stent member could
be within the main body or within the first branch body.
[0044] The use of bioabsorbable stent members near or at the side
opening is beneficial because it increases the stent's resistance
to fatigue. When stents are juxtaposed or extended across a
bifurcation in a vessel, for example, the juxtaposition or
extension may stress areas of the stent. By placing bioabsorbable
material at one or more of these high-stress areas, the
bioabsorbable material will be gradually absorbed into the body,
eliminating the stress. As a consequence of the absorption, the
inventive stent will separate from itself, leaving in some
embodiments the main body and the first branch body. Thus, the main
vessel and the branch vessel will be kept open by the remaining
portions of the stent. One skilled in the art will recognize that
by selecting different bioabsorbable materials or varying the
thickness of the bioabsorbable materials, the time it takes for the
material to bioabsorb can be controlled. Thus in accordance with
the present invention a bifurcated stent is provided wherein
bioabsorbtion of a desired region or regions of the stent is made
to occur immediately or soon after deployment, in several months,
in several years, or at different rates for different regions of
the stent. In some embodiments of the present invention, the first
branch body comprises a plurality of deflectable members 95, as
illustrated in side-view FIGS. 2a and 2b. These deflectable members
95 may define undulating petals, similar to those shown and
described in U.S. Patent Application Publication Nos. 2004/0138737
and 2005/0102023, the entire contents of each being incorporated
herein by reference. Each of the deflectable members 95 has a first
end 100 and a second end 105. As shown in FIG. 2a, the first end
100 of each deflectable member 95 extends from the main body 15 at
positions about the perimeter 65 of the side opening. In the
expanded state, depicted in FIG. 2b, the deflectable members 95
extend into the branch vessel. One of ordinary skill in the art
will recognize that there are a number of ways in which the
deflectable members 95 may be deflected, including inserting an
expandable balloon through the main body of the stent and through
the side opening (not depicted). FIG. 2a shows the second ends 105
of adjacent deflectable members 95 being connected by at least one
bioabsorbable stent member 70. In some embodiments it may be
desirable to have the bioabsorbable connectors degrade upon stent
deployment, such as depicted in FIG. 2b, which shows the
deflectable members 95 after the bioabsorbable stent members have
degraded.
[0045] In FIG. 3a, the embodiment of the stent depicted in FIG. 2a
further includes a bioabsorbable expansion joint 110. Specifically,
the perimeter 65 of the side opening 60 includes the bioabsorbable
expansion joint 110. Including at least one bioabsorbable expansion
joint allows the side opening to expand over time, reducing the
stress on the perimeter. FIG. 3b depicts the stent of FIG. 3a after
the bioabsorbable expansion joint 110 has degraded. This
degradation eliminates the stress on the perimeter by allowing the
perimeter to expand.
[0046] Referring now to FIG. 4a, in the embodiment shown, the body
wall 25 comprises a plurality of circumferential rings 115
longitudinally offset from one another about the main longitudinal
axis 35. In FIG. 4a, the first branch body 75 shown comprises at
least one branch ring 120 arranged about the first branch axis 80.
The branch ring 120 extends from the perimeter 65 of the side
opening by at least one bioabsorbable stent member 70. After the
bioabsorbable stent members degrade, the branch body 75 separates
from the perimeter 65, as illustrated in FIG. 4b.
[0047] In the embodiment depicted in FIG. 4a, adjacent
circumferential rings 115 are also connected to one another by
bioabsorbable stent members 70. As illustrated in FIG. 4c, this
allows at least a portion of the main body 25 to separate.
[0048] In some embodiments, as also depicted in FIG. 4a, the stent
comprises a plurality of branch rings 120. Adjacent branch rings
120 are connected to one another by at least one bioabsorbable
stent member 70. As illustrated in FIG. 4d, this allows at least a
portion of the branch body 75 to separate, leaving multiple branch
rings after the bioabsorbable stent member(s) degrade.
[0049] In the embodiment depicted in FIG. 5a, the perimeter 65 is
made up of at least one bioabsorbable stent member 70. The stent
further comprises a plurality of deflectable members 95, each
having a first end 100 and a second end 105. Provision of the
bioabsorbable perimeter mitigates fracturing between the main body
and the deflectable members. The first end 100 of each deflectable
member 95 extends from the main body 15 at positions about the
perimeter 65 of the side opening. In the expanded state, as shown
in FIG. 5a, the deflectable members 95 extend into a vessel branch.
FIG. 5b depicts the stent 12 of FIG. 5a after the bioabsorbable
stent member(s) 70 of the perimeter has degraded. As seen in FIG.
5b, the deflectable members 95 are separated from the main body 15
after the perimeter 65 has degraded.
[0050] In some embodiments, as depicted in FIG. 6a, the body wall
25 comprises a plurality of circumferential rings 115a being
longitudinally offset from one another about the main longitudinal
axis 35. As illustrated, at least two adjacent circumferential
rings 115a are connected to one another by at least one
bioabsorbable stent member 70. Also, at least one of the
circumferential rings 115a adjacent the perimeter 65 is connected
to the perimeter 65 by at least one bioabsorbable stent member 70.
In some embodiments, the stent includes deflectable members 95,
like in FIG. 6b.
[0051] In at least one embodiment, as shown in FIG. 6a, the stent
further comprises at least one circumferential ring 115b engaged to
the perimeter 65. One of the circumferential rings 115a adjacent
and connected to the perimeter 65 by at least one bioabsorbable
stent member 70 is also connected by at least one bioabsorbable
stent member 70 to a circumferential ring 115b engaged to the
perimeter 65. The stent further comprises a plurality of
deflectable members 95 having a first end 100 and a second end 105,
as shown in FIG. 6b. The first end 100 of each deflectable member
95 extends from the main body at positions about the perimeter
65.
[0052] Referring now to FIG. 7a, in at least one embodiment, at
least one bioabsorbable stent member 70 substantially covers the
side opening 60. As seen in FIG. 7a, the covering extends from the
perimeter 65. In some embodiments, the covering is engaged to the
perimeter by other bioabsorbable stent members 70, as in FIG. 7a.
In another embodiment, the covering extends directly from the
perimeter 65. In some embodiments, as shown in FIG. 7b, a plurality
of bioabsorbable stent members 70 substantially covers the side
opening 60. Although depicted as concentric circles, it should be
noted that the bioabsorbable stent members 70 could be arranged in
any number of designs to cover the side opening 60.
[0053] It should be noted that in the unexpanded state, the first
branch body 75 would lie flat on the main body 15. The first branch
body 75 could be expanded into a second lumen with a secondary
balloon attached to the main balloon, a POBA balloon pushed through
the center of the first branch body 75 and expanded, or a secondary
deployment object such as a conic-shaped feature at the end of a
catheter could be extended through first branch body 75 to push it
open.
[0054] Referring now to the embodiment depicted in FIG. 7b, the
first branch body 75, shown with ring-like stent members 70, could
be expanded into a second lumen by a ratcheting procedure. One of
ordinary skill in the art will recognize that there are a number of
ways in which the ratcheting can be performed. One ratcheting
method would be similar to that of zip ties, which allows the rings
to open, but prevents the ring from closing. In some embodiments,
the ring-like stent members 70 have elastic properties that allow
them to stretch open, at which point the ring-like stent members 70
either separate as they expand, or depending on the taper of the
second lumen, the ring-like stent members 70 are pushed into the
second lumen, resulting in a conical shape.
[0055] In the embodiment depicted in FIG. 8a, a Y-stent is
depicted. The stent 12 in FIG. 8a comprises a main body 15 and two
branches (20, 125). The main body 15 has a body wall 25 which
extends along a main longitudinal axis 35 from a proximal end 40 to
a distal end 45 and defines a lumen 50 therethrough. The body wall
25 is comprised of interconnected stent members 30.
[0056] As mentioned above, the bifurcated stent of FIG. 8a has two
branches, a first branch 20 and a second branch 125. The first
branch 20 has a first branch body 75 which extends along a first
branch longitudinal axis 80 when the stent 12 is in the expanded
state, as in FIG. 8a. Like the main body, the first branch body 75
is comprised of interconnected stent members 30.
[0057] The second branch 125 of stent 12 has a second branch body
130 which extends along a second branch longitudinal axis 135 when
the stent 12 is in the expanded state. The second branch body 130
is also comprised of interconnected stent members 30.
[0058] As seen in FIG. 8a, the first and second branch bodies 75,
130 extend from the main body 15 at its distal end 45. Furthermore,
at least one of the stent members 30 of the first branch body 75
and the second branch body 130 are connected to the main body 15 at
the distal end 45 by at least one bioabsorbable stent member
70.
[0059] FIG. 8b depicts the stent 12 of FIG. 8a after the
bioabsorbable stent members 70 have degraded. The first branch 20
and the second branch 125 have separated from the main body 15.
[0060] It should be noted that the terms "main body", "first
branch", and "second branch" do not imply that the diameter of the
main branch is larger than the diameters of the first or second
branches. Although this could be true, it is not necessarily so. In
some embodiments, the diameter of the first branch D2 or the
diameter of the second branch D3 is equal to or greater than the
main branch diameter D1.
[0061] Referring now to FIG. 9, in at least one embodiment the
expandable stent 12 has a main body 15 with a body wall 25 which
extends along a main longitudinal axis 35 from a proximal end 40 to
a distal end 45 and defining a lumen 50 therethrough.
[0062] As in other embodiments described above, the body wall 25 is
comprised of interconnected stent members 30, a plurality of which
define a plurality of cells 55. At least one of the cells 55 is a
side opening 60. The side opening 60 is distinguishable because it
is shaped differently then the other cells of the stent. In
general, the side opening 60 is shaped differently than the other
cells in that it is larger than the other cells. Additionally, the
side opening 60 has a perimeter 65. In the embodiment depicted in
FIG. 9, the perimeter 65 is bioabsorbable.
[0063] In some embodiments, the stent may include one or more
areas, bands, coatings, members, etc. that is (are) detectable by
imaging modalities such as X-Ray, MRI, ultrasound, etc. In some
embodiments at least a portion of the stent and/or adjacent
assembly is at least partially radiopaque.
[0064] In some embodiments at least a portion of the stent is
configured to include one or more mechanisms for the delivery of a
therapeutic agent. Often the agent will be in the form of a coating
or other layer (or layers) of material placed on a surface region
of the stent, which is adapted to be released at the site of the
stent's implantation or areas adjacent thereto.
[0065] A therapeutic agent may be a drug or other pharmaceutical
product such as non-genetic agents, genetic agents, cellular
material, etc. Some examples of suitable non-genetic therapeutic
agents include but are not limited to: anti-thrombogenic agents
such as heparin, heparin derivatives, vascular cell growth
promoters, growth factor inhibitors, Paclitaxel, etc. Where an
agent includes a genetic therapeutic agent, such a genetic agent
may include but is not limited to: DNA, RNA and their respective
derivatives and/or components; hedgehog proteins, etc. Where a
therapeutic agent includes cellular material, the cellular material
may include but is not limited to: cells of human origin and/or
non-human origin as well as their respective components and/or
derivatives thereof. Where the therapeutic agent includes a polymer
agent, the polymer agent may be a
polystyrene-polyisobutylene-polystyrene triblock copolymer (SIBS),
polyethylene oxide, silicone rubber and/or any other suitable
substrate.
[0066] The above disclosure is intended to be illustrative and not
exhaustive. This description will suggest many variations and
alternatives to one of ordinary skill in this art. The various
elements shown in the individual figures and described above may be
combined or modified for combination as desired. All these
alternatives and variations are intended to be included within the
scope of the claims where the term "comprising" means "including,
but not limited to".
[0067] Further, the particular features presented in the dependent
claims can be combined with each other in other manners within the
scope of the invention such that the invention should be recognized
as also specifically directed to other embodiments having any other
possible combination of the features of the dependent claims. For
instance, for purposes of claim publication, any dependent claim
which follows should be taken as alternatively written in a
multiple dependent form from all prior claims which possess all
antecedents referenced in such dependent claim if such multiple
dependent format is an accepted format within the jurisdiction
(e.g. each claim depending directly from claim 1 should be
alternatively taken as depending from all previous claims). In
jurisdictions where multiple dependent claim formats are
restricted, the following dependent claims should each be also
taken as alternatively written in each singly dependent claim
format which creates a dependency from a prior
antecedent-possessing claim other than the specific claim listed in
such dependent claim below.
[0068] This completes the description of the preferred and
alternate embodiments of the invention. Those skilled in the art
may recognize other equivalents to the specific embodiment
described herein which equivalents are intended to be encompassed
by the claims attached hereto.
* * * * *