Language selection

Search

Patent 2532028 Summary

Third-party information liability

Some of the information on this Web page has been provided by external sources. The Government of Canada is not responsible for the accuracy, reliability or currency of the information supplied by external sources. Users wishing to rely upon this information should consult directly with the source of the information. Content provided by external sources is not subject to official languages, privacy and accessibility requirements.

Claims and Abstract availability

Any discrepancies in the text and image of the Claims and Abstract are due to differing posting times. Text of the Claims and Abstract are posted:

  • At the time the application is open to public inspection;
  • At the time of issue of the patent (grant).
(12) Patent Application: (11) CA 2532028
(54) English Title: STENT WITH OVERLAPPED POINT MARKERS
(54) French Title: STENT A MARQUEURS DE POINTS SE CHEVAUCHANT
Status: Deemed Abandoned and Beyond the Period of Reinstatement - Pending Response to Notice of Disregarded Communication
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61F 02/91 (2013.01)
  • A61F 02/856 (2013.01)
  • A61F 02/915 (2013.01)
(72) Inventors :
  • NICHOLAS, PETER M. (United States of America)
(73) Owners :
  • BOSTON SCIENTIFIC LIMITED
(71) Applicants :
  • BOSTON SCIENTIFIC LIMITED (Bermuda)
(74) Agent: PIASETZKI NENNIGER KVAS LLP
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 2003-09-03
(87) Open to Public Inspection: 2005-04-14
Availability of licence: N/A
Dedicated to the Public: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US2003/027558
(87) International Publication Number: US2003027558
(85) National Entry: 2006-01-09

(30) Application Priority Data: None

Abstracts

English Abstract


A medical device and method of providing same, comprises a first stent body
(12) and a second stent body (16) wherein the medical device is formed when
the at least one first marker portion (28) and the at least one second marker
portion (28) of the stent bodies are positioned in a predetermined alignment
wherein the first stent body and the second stent body are aligned along
substantially the same longitudinal axis and at least a portion of the first
end region and at least a portion of the second end region of the respective
stent bodies are overlappingly arranged to provide the medical device with a
longitudinal length that is less than the sum of the first stent body length
and the second stent body length.


French Abstract

L'invention concerne un dispositif médical et un procédé de fabrication associé qui comprennent un premier corps de stent (12) et un second corps de stent (16), ledit dispositif médical étant formé lorsque la première partie du marqueur (28) et la seconde partie du marqueur (28) des corps du stent sont positionnées dans un alignement prédéterminé. Le premier corps du stent et le second corps du stent sont alignés sur pratiquement le même axe longitudinal et au moins une partie de la première zone d'extrémité et au moins une partie de la seconde zone d'extrémité des corps de stent respectifs sont disposées de façon à se chevaucher pour fournir au dispositif médical une longueur longitudinale inférieure à celle de la somme de la longueur du premier corps du stent et de la longueur du second corps du stent.

Claims

Note: Claims are shown in the official language in which they were submitted.


14
CLAIMS:
1.~A medical device comprising:
a first stent body, the first stent body having a first stent body length and
a first end region, the first end region having a predetermined degree of
radiopacity, at
least a portion of the first end region having at least one first marker
portion, the at least
one first marker portion having a predetermined degree of radiopacity
different than that
of the adjacent first end region; and
a second stent body, the second stent body having a second stent body
length and a second end region, the second end region having a predetermined
degree of
radiopacity, at least a portion of the second end region having at least one
second marker
portion, the at least one second marker portion having a predetermined degree
of
radiopacity different than that of the adjacent second end region,
the medical device being assembled when the at least one first marker
portion and the at least one second marker portion are positioned in a
predetermined
alignment wherein the first stent body and the second stent body are aligned
along
substantially the same longitudinal axis and at least a portion of the first
end region and
at least a portion of the second end region are overlappingly arranged to
provide the
medical device with a longitudinal length that is less than the sum of the
first stent body
length and the second stent body length.
2. ~The medical device of claim 1 wherein the medical device has a
substantially
uniform diameter throughout the longitudinal length.
3.~The medical device of claim 1 wherein at least one of the first stent body
and the
second stent body comprise at least one drug coating.
4. ~The medical device of claim 1 wherein at least a portion of the first
stent body
and at least a portion of the second stent body comprise at least one drug
coating.
5. ~The medical device of claim 4 wherein the at least one drug coating is
selectively
applied to the at first end region and the second end region so that when the
at least a
portion of the first end region and the at least a portion of the second end
region are
overlappingly arranged the exposed quantity of the coating per unit of surface
area of the
end regions is approximately half that of the exposed quantity of the coating
per unit of
surface elsewhere on the stent bodies.
6. ~The medical device of claim 4 wherein the coating is applied to the
surface of

15
each stent body such that when the at least a portion of the first end region
and the at
least a portion of the second end region are overlappingly arranged the amount
of
exposed coating is substantially uniform along the longitudinal length of the
medical
device.
7. ~The medical device of claim 1 wherein when the at least a portion of the
first end
region and the at least a portion of the second end region are overlappingly
arranged the
at least a portion of the first end region is engaged to the at least a
portion of the second
end region.
8.~The medical device of claim 7 wherein the at least a portion of the first
end
region defines a receiving surface and the at least a portion of the second
end region
defines at least one protrusion, the at least one protrusion being engaged to
the receiving
surface.
9. ~The medical device of claim 7 wherein the at least a portion of the first
end
region having a first magnetic polarity and the at least a portion of the
second end region
having a second magnetic polarity, the first magnetic polarity being
substantially
opposite the second magnetic polarity.
10. ~The medical device of claim 7 wherein the at least a portion of the first
end
region and the at least a portion of the second end region are chemically
engaged.
11. ~The medical device of claim 10 wherein the at least a portion of the
first end
region and the at least a portion of the second end region are adhesively
engaged.
12. ~The medical device of claim 1 wherein at least one of the first stent
body and
second stent body is self-expandable.
13. ~The medical device of claim 1 wherein at least one of the first stent
body and
second stent body is at least partially constructed from a shape-memory
material.
14. ~The medical device of claim 1 wherein when the at least a portion of the
first end
region and the at least a portion of the second end region are overlappingly
arranged, the
at least one first marker portion and the at least one second marker portion
are radially
adjacent one to the other.
15. ~The medical device of claim 1 wherein when the at least a portion of the
first end
region and the at least a portion of the second end region are overlappingly
arranged, the
at least one first marker portion and the at least one second marker portion
are
intermittently arranged about the circumference of the stent.

16
16. ~The medical device of claim 1 wherein the first marker portion and the
second
marker portion have the same degree of radiopacity.
17. ~The medical device of claim 1 wherein the marker portions are more
radiopaque
than the surrounding end regions.
18. ~The medical device of claim 1 wherein the marker portions are less
radiopaque
than the surrounding end regions.
19. ~The medical device of claim 1 wherein when the at least a portion of the
first end
region and the at least a portion of the second end region are overlappingly
arranged
about 0.25mm of the first end region overlaps about 0.25mm of the second
region.
20. ~The medical device of claim 1 wherein when the at least a portion of the
first end
region and the at least a portion of the second end region are overlappingly
arranged at
least 0.25mm of the first end region overlaps at least 0.25mm of the second
region.
21. ~The medical device of claim 1 wherein when the at least a portion of the
first end
region and the at least a portion of the second end region are overlappingly
arranged up
to about 20mm of the first end region overlaps up to about 20 mm of the second
region.
22. ~A method for providing a multi-stent assembly in a body lumen comprising
the
steps of:
advancing a first stent body to a predetermined location in the body
lumen, the first stent body having a first stent body length and a first end
region, the first
end region having a predetermined degree of radiopacity, at least a portion of
the first
end region having at least one first marker portion, the at least one first
marker portion
having a predetermined degree of radiopacity different than that of the
adjacent first end
region;
delivering the first stent body by expanding the first stent body to an
expanded state;
advancing a second stent body to a location in the body lumen
longitudinally adjacent to the first stent body, the second stent body having
a second
stent body length and a second end region, the second end region having a
predetermined degree of radiopacity, at least a portion of the second end
region having
at least one second marker portion, the at least one second marker portion
having a
predetermined degree of radiopacity different than that of the adjacent second
end
region;

17~
aligning the at least one first stent marker and the at least one second
stent marker so that the first stent body and the second stent body are
aligned along
substantially the same longitudinal axis and at least a portion of the first
end region and
at least a portion of the second end region are overlappingly arranged;
delivering the second stent body by expanding the second stent body to
an expanded state, such that when the second stent body and the first stent
body are both
in their respective expanded states the assembly is provided with a
longitudinal length
that is less than the sum of the first stent body length and the second stent
body length.
23. ~The method of claim 22 wherein the assembly has a substantially uniform
diameter throughout the longitudinal length.
24. ~The method of claim 22 wherein at least one of the first stent body and
the
second stent body comprise at least one drug coating.
25. ~The method of claim 22 wherein at least a portion of the first stent body
and at
least a portion of the second stent body comprise at least one drug coating.
26. ~The method of claim 25 wherein the at least one drug coating is
selectively
applied to the at first end region and the second end region so that when the
at least a
portion of the first end region and the at least a portion of the second end
region are
overlappingly arranged the exposed quantity of the coating per unit of surface
area of the
end regions is approximately half that of the exposed quantity of the coating
per unit of
surface elsewhere on the stent bodies.
27. ~The method of claim 25 wherein the coating is applied to the surface of
each
stent body such that when the at least a portion of the first end region and
the at least a
portion of the second end region are overlappingly arranged the amount of
exposed
coating is substantially uniform along the longitudinal length of the method.
28. ~The method of claim 22 wherein when the at least a portion of the first
end
region and the at least a portion of the second end region are overlappingly
arranged the
at least a portion of the first end region is engaged to the at least a
portion of the second
end region.
29. ~The method of claim 28 wherein the at least a portion of the first end
region
defines a receiving surface and the at least a portion of the second end
region defines at
least one protrusion, the at least one protrusion being engaged to the
receiving surface.
30. ~The method of claim 28 wherein the at least a portion of the first end
region

18
having a first magnetic polarity and the at least a portion of the second end
region
having a second magnetic polarity, the first magnetic polarity being
substantially
opposite the second magnetic polarity.
31. The method of claim 28 wherein the at least a portion of the first end
region and
the at least a portion of the second end region are chemically engaged.
32. The method of claim 31 wherein the at least a portion of the first end
region and
the at least a portion of the second end region are adhesively engaged.
33. The method of claim 22 wherein at least one of the first stent body and
second
stent body is self-expandable.
34. The method of claim 22 wherein at least one of the first stent body and
second
stent body is at least partially constructed from a shape-memory material.
35. The method of claim 22 wherein when the at least a portion of the first
end
region and the at least a portion of the second end region are overlappingly
arranged, the
at least one first marker portion and the at least one second marker portion
are radially
adjacent one to the other.
36. The method of claim 22 wherein when the at least a portion of the first
end
region and the at least a portion of the second end region are overlappingly
arranged, the
at least one first marker portion and the at least one second marker portion
are
intermittently arranged about the circumference of the stent.
37. The method of claim 22 wherein the first marker portion and the second
marker
portion have the same degree of radiopacity.
38. The method of claim 22 wherein the marker portions are more radiopaque
than
the surrounding end regions.
39. The method of claim 22 wherein the marker portions are less radiopaque
than
the surrounding end regions.
40. A medical device comprising:~
a first stent body, the first stent body defining a bifurcation crown the
bifurcation crown defining an opening in the first stent body, the bifurcation
crown
having a predetermined degree of radiopacity, at least a portion of the
bifurcation crown
having at least one first marker portion, the at least one first marker
portion having a
predetermined degree of radiopacity different than that of the adjacent
bifurcation
crown; and

19
a second stent body, the second stent body having an end region, the end
region having a predetermined degree of radiopacity, at least a portion of the
end region
having at least one second marker portion, the at least one second marker
portion having
a predetermined degree of radiopacity different than that of the adjacent end
region,
the medical device being assembled when the at least one first marker
portion and the at least one second marker portion are positioned in a
predetermined
alignment wherein the bifurcation crown of the first stent body and the end
region of the
second stent body at least partially overlap.
41. ~The medical device of claim 40 wherein the bifurcation crown defines a
first
longitudinal axis and the second stent body defines a second longitudinal
axis, when the
bifurcation crown of the first stent body and the end region of the second
stent body at
least partially overlap the first longitudinal axis and the second
longitudinal axis are
substantially the same.
42. ~The medical device of claim 40 wherein the bifurcation crown defines a
first
longitudinal axis and the second stent body defines a second longitudinal
axis, when the
bifurcation crown of the first stent body and the end region of the second
stent body at
least partially overlap the first longitudinal axis and the second
longitudinal axis
substantially parallel to one another.

Description

Note: Descriptions are shown in the official language in which they were submitted.


CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
STENT WITH OVERLAPPED POINT MARKERS
CROSS-REFERENCE TO RELATED APPLICATIONS
Not Applicable
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
Not Applicable
BACKGROUND OF THE INVENTION
Stems, grafts, stmt-grafts, vena cava filters and similar implantable
medical devices, collectively referred to hereinafter as stems, are radially
expandable
endoprostheses which are typically intravascular implants capable of being
implanted
transluminally and enlarged radially after being introduced percutaneously.
Stems may
be implanted in a variety of body lumens or vessels such as within the
vascular system,
urinary tracts, bile ducts, etc. Stems may be used to reinforce body vessels
and to
prevent restenosis following angioplasty in the vascular system. 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.
Balloon expandable stems are typically disposed about a balloon which
must be positioned and inflated to expand the stent radially outward. Self
expanding
scents expand into place when unconstrained, without requiring assistance from
a
balloon. Some stems may be characterized as hybrid stems which have some
characteristics of both self expandable and balloon expandable stems.
Typically, a stmt or other endoluminal prosthesis is implanted in a vessel
at the site of a stenosis or aneurysm by so-called "minimally invasive
techniques" in
which the stmt is compressed radially inwards and is delivered by a catheter
to the site
where it is required. When the stent is positioned at the correct location,
the stmt is
caused or allowed to expand to a predetermined diameter in the vessel and the
catheter
is withdrawn.
In the past, stems have been generally tubular but have been composed of
many configurations and have been made of many materials, including metals and

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
2
plastic. Ordinary metals such as stainless steel have been used as have shape
memory
metals such as Nitinol and the like. Stems have also been made of bio-
absorbable plastic
materials. Stems have been formed from wire, tube stock, etc. Stems have also
been
made from sheets of material which are rolled.
In order to better provide for the precise placement of the stmt within a
body location some stems include radiopaque materials which may be detected
through
the use of fluoroscopy. In this manner the position of the stmt within a body
vessel may
be identified. Radiopaque materials are well known and have been incorporated
into
stems in several ways. For example, in U.S. 6,402,777 rivets made of
radiopaque
material are positioned in stmt openings; in U.S. 5,725,572 a stmt is said to
include a
radiopaque material affixed to undeformed components at the distal or proximal
end of
the stmt; and in U.S. 5,954,743 at least partially plating a stmt with
radiopaque material
is described.
Stems are known to have a variety of shapes sizes and structural features.
For example, stems may have a variety of lengths, diameters, cell
configurations, end
effects, etc. Stems may be branched or segmented for use in a vessel
bifurcation. Such
stems may also include one or more ports or crowns where additional stmt
bodies may
be engaged. Some examples of stems having at least some of the structural
features
mentioned above are described in the following references: U.S. Pat. App.
10/084,766;
U.S. Pat. App.lO/083,707; U.S. Pat. App. 10/083,711.
In some cases it is necessary or desirable to place multiple stems, so that
the stems are arranged in an end to end manner within a vessel or other body
space.
Recent studies have shown that in some cases, such as in some applications of
drug
coated stems, prevention of restenosis may be improved when the ends of
adjacent
stems are made to overlap one another according to a predetermined alignment.
Currently however, precise multiple stmt alignment wherein the overlapping
stems have
a preferred length of stmt end overlap is difficult to achieve.
All US patents and applications and all other published documents
referred to anywhere in this application are incorporated herein by reference
in their
entirety.
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

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
3
summarized embodiments of the invention and/or additional embodiments of the
invention may be found in the Detailed Description of the Invention below.
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 OF THE INVENTION
The present invention is embodied in a variety of different forms. For
example, some embodiments of the invention are directed to methods and systems
for
treating a stenosis by implanting at least two stems or stmt bodies into a
vessel, wherein
the stmt bodies are placed in an overlapping relationship. In order to provide
the
resulting stmt assembly with stmt bodies having a desired overlapping
configuration,
the respective stmt ends are provided with one or more alignment markers that
allow
the stent end to be overlappingly aligned in a very precise manner. The
markers may
have a greater or lesser degree of radiopacity than the surrounding end
regions. In at
least one embodiment the markers and/or other portions of the stmt bodies may
be MRI
compatible.
In the various embodiments of the invention, the manner and degree, or
length, of stmt overlap may be varied. For example, in some embodiments the
overlapping stmt bodies are configured such that when they are overlapped, at
least a
portion of one stmt is positioned radially within the lumen defined by another
stmt. In
some embodiments the overlapping stmt bodies are configured such that when
they are
overlapped, the stmt bodies are longitudinally adjacent to one another. In at
least one
embodiment in the region where the longitudinally adjacent stmt bodies are
overlapped,
the diameter of each stent body is substantially the same.
In some embodiments the invention is directed to a bifurcated stmt that
defines a side opening, crown or branch. The branch may be configured to
overlap, or
be overlapped by a secondary stmt body.
In some embodiments at least a portion of at least one of the stems is
drug coated. In at least one embodiment, the end of at least one stmt is
coated. In at
least one embodiment one or more ends of adjacent stems are selectively
coated. By
selectively coating the ends of adjacent stems, the overlapping ends of the
stems may be

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
4
provided with amounts or concentrations of coating such that overlapping ends
of the
stent bodies provide a coated interface with the surrounding vessel that is
substantially
the same as the non-overlapped coated portions of the stent bodies. In at
least one
embodiment the ends of the stmt bodies may be selectively coated to have
different
proportions of the drug coating relative to the proportion of coating on the
remaining
portions of the respective stmt bodies. In at least one embodiment the
proportionally
amount of drug coating on the overlapped portion of the stems may be greater
than or
less than the amount of drug coating elsewhere on the stmt bodies.
In at least one embodiment at least a portion of the adjacent ends of the
stmt bodies are engaged to one another. In at least one embodiment overlap of
the ends
of the stems is by frictional, mechanical, electromagnetic, chemical, or other
engagement. In at least one embodiment the at least one stent end is uniquely
keyed to
the end of an adj acent stmt.
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 a better 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 DRAWINGS)
A detailed description of the invention is hereafter described with
specific reference being made to the drawings.
FIG. 1 is a side view of an embodiment of the invention.
FIG. 2 is a side view of the embodiment shown in FIG. 1 wherein the
individual stmt bodies are shown separated.
FIG. 3 is a cross-sectional view of an embodiment of the invention.
FIG. 4 is a cross-sectional view of an embodiment of the invention.
FIG. 5 is a close-up partial side view of an embodiment of the invention
illustrating an example alignment of markers.
FIG. 6 is a close-up partial side view of an embodiment of the invention
illustrating an example alignment of markers.

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
FIG. 7 is a close-up side view of an embodiment of the invention wherein
the ends of the assembly are engaged to one another.
FIG. 8 is a close-up side view of an embodiment of the invention wherein
the ends of the assembly are engaged to one another.
FIG. 9 is a side view of an embodiment of the invention.
FIG. 10 is a close-up side view of an embodiment of the invention
wherein the assembly includes a coating.
FIG. 11 is a close-up side view of an embodiment of the invention
wherein the assembly is includes a coating.
DETAILED DESCRIPTION OF THE INVENTION
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.
For the purposes of this disclosure, like reference numerals in the figures
shall refer to like features unless otherwise indicated.
As indicated above, the present invention is directed to a variety of
different embodiments. An example of one such embodiment is shown in FIG. 1
wherein a stmt assembly, indicated generally at 10, is shown. In various
embodiments
of the invention stmt assembly 10 may be comprised of two or more stems or
stmt
bodies 12 and 14 such as is shown in FIG. 2. Stent bodies may be any sort of
implantable prosthesis such as stems, grafts, stmt-grafts, vena cava filters,
etc.
Stent bodies 12 and 14 may be balloon expandable stems, self
expandable, or hybrid expandable. Stent bodies 12 and 14 may be single layer
or multi-
layer devices. The bodies may have the same or different construction and
expansion
characteristics. In some embodiments, one or more of the stmt bodies 12 and 14
may be
at least partially constructed from a shape memory metal such as nitinol (Ni-
Ti), or a
shape-memory polymer.
To form stmt assembly 10, stmt bodies 12 and 14 are positioned
together such that at least a portion of their respective end regions 16 and
18 at least
partially overlap one another. As indicated above, the manner and degree of
end overlap

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
6
may be varied. For example, in the embodiment shown in FIG. 1, the end regions
16
and 18 of each stmt body 12 and 14 have a similar and complimentary
configuration
which allows at least a portion of the end regions 16 and 18 to interpenetrate
one
another. Where the stmt bodies 12 and 14 are aligned along the same
longitudinal axis
15 such as is shown in FIG. 2, the assembly 10 will be provided with
substantially the
same outer diameter through out its longitudinal length.
However, it is recognized that the overlap of end regions 16 and 18 need
not always be longitudinally and/or radially aligned. For example, in some
cases the
stmt bodies 16 and 18 may be aligned and overlapped to successfully form
assembly 10
even though the stmt bodies 16 and 18 have different longitudinal axes,
represented as
reference numerals 15a and 15b respectively, such as is shown in FIG. 3. In
another
embodiment illustrated in FIG. 4, end region 18 of stmt body 14 may be
positioned
radially within end region 16 of stmt body 12. In the embodiment shown in FIG.
4 the
stmt bodies 12 and 14 may have substantially the same longitudinal axis 15,
but in the
portion of the assembly 10 defined by the overlapping end regions 16 an 18 the
diameter
of stmt 12 is less than the diameter of stmt 16.
Depending on the particular construction of the stent bodies, other
configurations may be possible. Such configurations of overlap made possible
by the
present invention and are incorporated within its scope.
In order to properly control the alignment and length of overlap of stmt
bodies 12 and 14, the stems, or portions thereof may include marker portions
28 that
allow the end regions 16 and 18 to be visually or otherwise aligned, such as
is shown in
the various figures.
Markers 28 are preferably constructed from materials that are visually
distinct or otherwise detectable. For example, in some embodiments the markers
are at
least partially constructed from one or more radiopaque materials such as
radiopaque
metals and/or radiopaque polymers. Though radiopacity is the characteristic
that shall
be discussed in detail, it should be understood that in some embodiments,
markers 28
may be MRI compatible and detectable thereby, X-ray detectable, radio
luminescent,
may be visually distinct to the naked eye, etc.
In some cases the markers 28 are constructed of radiopaque material to
make the markers 28 more visible during fluoroscopy or similar procedures,
however in

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
7
some embodiments, particularly those wherein the end regions 16 and 18 or
other
portions of the stents 12 and 14 are themselves radiopaque, the markers 28 may
be
selected to be more or less radiopaque than the surrounding portions of the
stems.
The presence of radiopaque markers 28 on the end regions 16 and 18 of
the stmt bodies 12 and 14, allows the operator or surgeon to position the
second stmt 14
in relation to the deployed first stmt 12 in a precise overlapping alignment
configuration, such as any of those described above. The markers located in
their
respective end regions 16 and 18 may be placed in overlapping alignment or
some other
recognizable configuration or pattern to ensure proper alignment of the stmt
bodies 12
and 14. In this manner the markers 28 act as guides to ensure that the proper
overlapping arrangement of the end regions 16 and 18 has been achieved.
The extent end regions 16 and 18 are overlapped may depend on a variety
of circumstances. For example, where the assembly 10 is utilized in a coronary
vessel
the length of overlap between the stmt end regions 16 and 18 is between about
0.25 mm
to about 10 mm, however when the assembly is placed in a peripheral vessel,
the
overlap may be as great as 20 mm.
The particular material, shape, arrangement, placement, etc. of markers
28 on the end regions 16 and 18 may be any desired. For example, the markers
28 may
be at least a portion of one or more individual stmt members or be positioned
extraneously thereon. The markers may comprise a radiopaque material that is
more or
less radiopaque than that of the surrounding stmt body or bodies 12 and 14.
The
markers 28 may be an inherent portion of the end regions 16 and 18.
Alternatively, the
end regions 16 and 18 or portions thereof may be selectively or entirely
coated, plated,
or otherwise provided with one or more markers 28, such as for example by
providing
and end region with one or more radiopaque rivets, welds, wires or other
structures.
In some embodiments the markers 28 in the completed assembly 10 may
be adjacent to one another in a substantially radial, circumferential,
longitudinal or other
manner. In some embodiments, the markers 28 may be positioned such that
markers are
spaced apart from one another according to a desired pattern, an example of
which being
illustrated in FIG. 5. In another embodiment shown in FIG. 6, the markers 28
are
intermittently arranged in a pattern about the circumference of the stems 12
and 14, such
that when viewed during fluoroscopy the markers 28 appear to form one or more
lines,

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
8
or other patterns. Other configurations and arrangements are possible and are
within the
scope of this invention.
In the embodiments discussed thus far the formation of assembly 10 is
accomplished by deploying the first stmt body 12 into the vessel and then
subsequently
deploying the second stmt body 14 in proximity to the first stmt body 12 so
that the end
regions 16 and 18 overlap in the manner desired. In these embodiments however,
the
aligmnent of the stems 12 and 14 within the vessel and any frictional
engagement that
may occur between contacting end regions 16 and 18 may be the primary forces
acting
to hold the stems together in precise aliglunent.
In order to more securely engage end regions 16 and 18 together, some
embodiments of the invention employ various engagement mechanisms and devices
to
engage end regions 16 and 18 together. For example, in FIG. 7 the end regions
16 and
18 may be provided with engagement surfaces 22 that provide improved
frictional,
mechanical, chemical, and/or even electromagnetic interface between the end
regions 16
and 18 or portions thereof.
An example of one form of engagement surfaces) 22, is illustrated in the
embodiment shown in FIG. 8, wherein opposing end regions 16 and 18 are
respectively
provided with one or more protrusions 24 and receiving surfaces 26. In the
embodiment
shown, the interface of protrusions 24 and receiving surfaces 26 may provide
increased
frictional engagement between the regions 16 and 18.
In some embodiments, at least a portion of one or more of the protrusions
24 andlor receiving surfaces 26 may be constructed of a shape memory material
allowing the protrusions 24 and/or surfaces 26 to transform to a preset shape
upon
exposure to an environmental trigger such as a predetermined temperature,
electric
current, pH, etc. In this manner the protrusions 24 and/or receiving surfaces
26 may by
made to actively and mechanically engage one another for improved securement
of the
overlapping regions 16 and 18.
In another example, the engagement surfaces 22 may include a coating
which adhesively or otherwise aids in chemical engaging the overlapping
surfaces
together.
In yet another example, at least a portion of the end regions 16 and 18,
such as engagement surfaces 22, are provided with opposing magnetic polarity
to

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
9
electro-magnetically engage the overlapping surfaces together.
In some embodiments, the stmt bodies 12 and 14 or portions thereof, are
bioabsorbable to allow the individual stmt bodies 12 and 14 to be removed from
the
body or absorbed thereby at a point in time subsequent to placement of the
assembly 10.
As indicated above, some embodiments of the invention are directed to
bifurcated stmt assemblies, an example of which is shown in FIG. 9. In the
embodiment shown a bifurcated assembly, indicated generally at 10, comprises a
first
stmt body 12 and a second stent body 14. First stmt body 12 defines a side
opening 30.
In some embodiments, the side opening 30 may be further defined by a crown or
branch
32 of stent material.
In the embodiment shown in FIG. 9 the side opening 30, and/or crown 32
is at least partially defined by one or more markers 28. The second stmt body
14
includes an end region 18 which comprises one or more markers 28 as well. In
application, after either the first stmt body 12 or second stent body 14 is
delivered to a
bifurcation in a vessel or body lumen, the other body 12 or 14 is positioned
adjacent
thereto so that at least a portion of the end region 18 of the second stent
body 14 and the
opening 30 and/or crown 32 of the first stmt body 12 are overlapped. The
particular
configuration of overlap between stmt bodies 12 and 14 may include any
configuration
such as those described above.
When the end region 18 and opening 30 and/or crown 32 are overlapped
in a desired configuration, the markers of the respective end region 18 and
opening 30
and/or crown 32 will have a predetermined alignment such as is shown in FIGs.
5 and 6.
As is shown in FIG. 9, crown 32 defines a longitudinal axis 15c which the
longitudinal
axis 15b of the second stmt body may or may not be aligned with such as in the
manners previously described in FIGS. 3 and 4. The overlap of the bodies 12
and 14
forming the completed bifurcated assembly 10 of FIG. 9 may include a physical
overlap
and/or engagement of the bodies 12 and 14 such as is shown in FIGs. 7 and 8.
In some embodiments, the assembly 10 is at least partially coated with a
drug or other substance, the extent that the stmt bodies 12 and 14 are coated
with a drug
or other coating may also affect the manner and degree of the stent overlap.
In some embodiments, particularly those wherein one or more of the
stmt bodies 12 and 14 are include a drug coating or other drug delivery
mechanism, the

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
extent or length of the overlap of the end regions 16 and 18 may be of
particular
importance.
Drugs and coatings thereof are well known. The application of such a
coating to a stmt allows the stmt to deliver the drug directly to a desired
location within
5 the vessel. However, in many applications it may be of importance to ensure
that the
concentration, amount, or exposure of the drug along a given length of the
stmt is
substantially consistent. Thus, in some embodiments of the present invention,
such as is
shown in FIG. 10, the assembly 10 employs a coating 21 of drug that extends
across the
overlapping end regions 16 and 18. In order to ensure that the exposure of the
drug is
10 substantially the same over the length of the assembly, the end regions 16
and 18 are
selectively coated to an extent less than adjacent regions of the respective
stent bodies
12 and 14, such that when regions 16 and 18 are overlapped to form assembly 10
the
exposure of the coating is substantially equal along the entire coated length
of the
assembly 10.
It should be noted, that where a consistent concentration or exposure of a
coating is desired, the end regions 16 and 18 need not be selectively coated
to an equal
proportion. For example, in the embodiment shown in FIG. 11, end region 16 is
fully
coated (one hundred percent), whereas end region 18 is not at all coated (zero
percent).
However, the extent of exposure of coating 21 remains substantially constant
along the
length of the completed assembly 10. In other embodiments, end regions 16 and
18 may
be provided with other proportions of coating. In one example for instance,
end region
16 may be provided with a 75 percent coating, whereas end region 18 has only
25
percent.
In other embodiments, it may be desired to provide a greater or lesser
concentration or exposure of coating 21. In such embodiments, the end regions
16 and
18 may be selectively coated so that when they are overlapped to form assembly
10 the
concentration of coating at the overlapped regions 16 and 18 is different than
that of the
concentration elsewhere along the length of the assembly 10.
In the various embodiments described above, drug coating 21 may be
comprised of any or all of a variety of drugs, genetic material, non-genetic
therapeutic
agents, cells andlor cellular material, polymer coatings, viruses, retro-
viruses, and/or
other substances. In some embodiments, coating 21 is at least partially
radiopaque.

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
11
Some particular examples of materials suitable for use as a coating
include but are not limited to: anti-thrombogenic agents such as heparin,
heparin
derivatives, urokinase, PPack (dextrophenylalanine proline arginine
chloromethylketone), etc.; anti-proliferative agents such as enoxaprin,
angiopeptin, or
monoclonal antibodies capable of blocking smooth muscle cell proliferation,
hirudin,
acetylsalicylic acid, etc.; anti-inflammatory agents such as dexamethasone,
prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, mesalamine,
etc.;
antineoplastic/antiproliferative/anti-miotic agents such as paclitaxel, 5-
fluorouracil,
cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin,
thymidine kinase
inhibitors, etc.; anesthetic agents such as lidocaine, bupivacaine,
ropivacaine, etc.; anti-
coagulants such as D-Phe-Pro-Arg chloromethyl keton, an RGD peptide-containing
compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-
thrombin anticodies, anti-platelet receptor antibodies, aspirin, prostaglandin
inhibitors,
platelet inhibitors, tick antiplatelet peptides, etc.; vascular cell growth
promotors such as
growth factor inhibitors, growth factor receptor antagonists, transcriptional
activators,
translational promoters, etc.; 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, etc.;
cholesterol-
lowering agents; vasodilating agents; agents which interfere with endogenous
vascoactive mechanisms; anti-sense DNA and RNA; DNA coding for anti-sense RNA;
DNA coding for tRNA or rRNA to replace defective or deficient endogenous
molecules;
DNA coding for angiogenic factors including growth factors such as acidic and
basic
fibroblast growth factors, vascular endothelial growth factor, epidermal
growth factor,
transforming growth factor a and Vii, platelet-derived endothelial growth
factor, platelet-
derived growth factor, tumor necrosis factor cx, hepatocyte growth factor and
insulin like
growth factor; DNA coding for cell cycle inhibitors including CD inhibitors;
DNA
coding for thymidine kinase ("TK") and other agents useful for interfering
with cell
proliferation; DNA coding for the family of bone morphogenic proteins
("BMP's")
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, BMP-16, and dimeric

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
12
proteins provided as homodimers, heterodimers, or combinations thereof, alone
or
together with other molecules, as well as other associated proteins; cells or
portions
thereof of human origin (autologous or allogeneic) or from an animal source
(xenogeneic), genetically engineered if desired to deliver proteins of
interest at the
transplant site; polycarboxylic acids; cellulosic polymers, including
cellulose acetate and
cellulose nitrate; gelatin; polyvinylpyrrolidone; cross-linked
polyvinylpyrrolidone;
polyanhydrides including malefic anhydride polymers; polyamides; polyvinyl
alcohols;
copolymers of vinyl monomers such as EVA; polyvinyl ethers; polyvinyl
aromatics;
polyethylene oxides; glycosaminoglycans; polysaccharides; polyesters including
polyethylene terephthalate; polyacrylamides; polyethers; polyether sulfone;
polycarbonate; polyalkylenes including polypropylene, polyethylene and high
molecular
weight polyethylene; halogenated polyalkylenes including
polytetrafluoroethylene;
polyurethanes; polyorthoesters; proteins; polypeptides; silicones; siloxane
polymers;
polylactic acid; polyglycolic acid; polycaprolactone; polyhydroxybutyrate
valerate and
blends and copolymers thereof; coatings from polymer dispersions such as
polyurethane
dispersions (BAYHDROL~, etc.); fibrin; collagen and derivatives thereof;
polysaccharides such as celluloses, starches, dextrans, alginates and
derivatives;
hyaluronic acid; squalene emulsions; polyacrylic acid, such as HYDROPLLTS~
available from Boston Scientific Corporation, Natick, Mass., and described in
LT.S. Pat.
No. 5,091,205, the entire disclosure of which is hereby incorporated herein by
reference;
etc.
While the figures included herewith illustrate the relationship between
two stmt bodies to form the completed assembly, it should be recognized that
the
inventive assembly and the accompanying method for providing same as described
herein may comprise more than two stems or stmt bodies overlappingly arranged
in
similar or different manners.
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. 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".
Those familiar with the art may recognize other equivalents to the specific
embodiments described herein which equivalents are also intended to be
encompassed

CA 02532028 2006-O1-09
WO 2005/032424 PCT/US2003/027558
13
by the claims.
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.
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.

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

2024-08-01:As part of the Next Generation Patents (NGP) transition, the Canadian Patents Database (CPD) now contains a more detailed Event History, which replicates the Event Log of our new back-office solution.

Please note that "Inactive:" events refers to events no longer in use in our new back-office solution.

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Event History , Maintenance Fee  and Payment History  should be consulted.

Event History

Description Date
Inactive: IPC deactivated 2020-02-15
Inactive: First IPC assigned 2019-05-03
Inactive: IPC assigned 2019-05-03
Inactive: IPC assigned 2019-05-03
Inactive: IPC assigned 2019-05-03
Inactive: IPC expired 2013-01-01
Deemed Abandoned - Failure to Respond to Maintenance Fee Notice 2009-09-03
Inactive: Dead - RFE never made 2009-09-03
Application Not Reinstated by Deadline 2009-09-03
Inactive: Abandon-RFE+Late fee unpaid-Correspondence sent 2008-09-03
Inactive: Cover page published 2006-03-09
Inactive: Notice - National entry - No RFE 2006-03-06
Letter Sent 2006-03-06
Letter Sent 2006-03-06
Application Received - PCT 2006-02-08
National Entry Requirements Determined Compliant 2006-01-09
Application Published (Open to Public Inspection) 2005-04-14

Abandonment History

Abandonment Date Reason Reinstatement Date
2009-09-03

Maintenance Fee

The last payment was received on 2008-06-27

Note : If the full payment has not been received on or before the date indicated, a further fee may be required which may be one of the following

  • the reinstatement fee;
  • the late payment fee; or
  • additional fee to reverse deemed expiry.

Patent fees are adjusted on the 1st of January every year. The amounts above are the current amounts if received by December 31 of the current year.
Please refer to the CIPO Patent Fees web page to see all current fee amounts.

Fee History

Fee Type Anniversary Year Due Date Paid Date
Basic national fee - standard 2006-01-09
MF (application, 2nd anniv.) - standard 02 2005-09-06 2006-01-09
Registration of a document 2006-01-09
MF (application, 3rd anniv.) - standard 03 2006-09-05 2006-07-25
MF (application, 4th anniv.) - standard 04 2007-09-04 2007-07-03
MF (application, 5th anniv.) - standard 05 2008-09-03 2008-06-27
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
BOSTON SCIENTIFIC LIMITED
Past Owners on Record
PETER M. NICHOLAS
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
Documents

To view selected files, please enter reCAPTCHA code :



To view images, click a link in the Document Description column. To download the documents, select one or more checkboxes in the first column and then click the "Download Selected in PDF format (Zip Archive)" or the "Download Selected as Single PDF" button.

List of published and non-published patent-specific documents on the CPD .

If you have any difficulty accessing content, you can call the Client Service Centre at 1-866-997-1936 or send them an e-mail at CIPO Client Service Centre.


Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Description 2006-01-08 13 752
Claims 2006-01-08 6 324
Drawings 2006-01-08 9 208
Abstract 2006-01-08 1 62
Representative drawing 2006-01-08 1 18
Notice of National Entry 2006-03-05 1 193
Courtesy - Certificate of registration (related document(s)) 2006-03-05 1 105
Courtesy - Certificate of registration (related document(s)) 2006-03-05 1 105
Reminder - Request for Examination 2008-05-05 1 126
Courtesy - Abandonment Letter (Request for Examination) 2008-12-09 1 166
Courtesy - Abandonment Letter (Maintenance Fee) 2009-10-28 1 171
PCT 2006-01-08 6 255
Fees 2006-07-24 1 44
Fees 2007-07-02 1 47
Fees 2008-06-26 1 47