U.S. patent application number 11/385621 was filed with the patent office on 2006-07-20 for interlocking endoluminal device.
Invention is credited to Ronald Rakos, Krzysztof Sowinski.
Application Number | 20060161245 11/385621 |
Document ID | / |
Family ID | 21746616 |
Filed Date | 2006-07-20 |
United States Patent
Application |
20060161245 |
Kind Code |
A1 |
Rakos; Ronald ; et
al. |
July 20, 2006 |
Interlocking endoluminal device
Abstract
An endoluminal device comprises at least a first member and a
second member, which may be modular. The first member comprises a
first trunk portion, a first midsection comprising a first opening,
and a first leg portion. The second member comprises a second trunk
portion, a second midsection comprising a second opening, and a
second leg portion. The device has an assembled configuration in
which the first member and second member are interlocked with one
another with the second trunk portion coaxially contained within
the first trunk portion, the second leg portion protruding through
the first opening, and the second opening facing the first leg
portion. The second midsection may have a leg stump portion that
protrudes into the first leg portion of the first member in the
assembled configuration. A system and method for deploying the
device may use identical catheters for deploying the two
members.
Inventors: |
Rakos; Ronald; (Neshanic
Station, NJ) ; Sowinski; Krzysztof; (Wallington,
NJ) |
Correspondence
Address: |
RATNER PRESTIA
P.O. BOX 980
VALLEY FORGE
PA
19482
US
|
Family ID: |
21746616 |
Appl. No.: |
11/385621 |
Filed: |
March 21, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10010628 |
Nov 7, 2001 |
7029496 |
|
|
11385621 |
Mar 21, 2006 |
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Current U.S.
Class: |
623/1.35 |
Current CPC
Class: |
A61F 2/07 20130101; A61F
2002/067 20130101 |
Class at
Publication: |
623/001.35 |
International
Class: |
A61F 2/06 20060101
A61F002/06 |
Claims
1. A modular endoluminal device comprising an outer member and an
inner member, the outer member and inner member each comprising a
stent-graft, a fluid inlet opening, a first fluid exit opening, and
a second fluid exit opening, the device having an assembled
configuration in which the inner member fits partially inside the
outer member and partially protrudes through the outer member first
exit opening such that the inner member inlet opening aligns with
the outer member inlet opening and the inner member first exit
opening aligns with the outer member second exit opening, the
device adapted to receive a fluid stream through the aligned inner
and outer member inlet openings and to discharge the fluid from the
device in two discharge streams, one through each of the second
fluid exit openings.
2. The endoluminal device of claim 1, wherein the outer member
further comprises a seal ring.
3. The endoluminal device of claim 2, wherein the seal ring is
positioned adjacent the fluid inlet opening.
4. The endoluminal device of claim 2, wherein the seal ring is
positioned adjacent the first fluid exit opening.
5. The endoluminal device of claim 1, wherein at least one
stent-graft comprises a textile, a plastic, or a combination
thereof.
6. The endoluminal device of claim 1, wherein the device is adapted
to be mounted in an aorta and the stent-graft comprises an
uncovered stent portion positioned to be located at an intersection
of a renal lumen with the aorta.
7. The endoluminal device of claim 6, wherein the uncovered stent
portion comprises a hexagonal cell design.
8. The endoluminal device of claim 1, wherein each of the inner
member and the outer member has a tapered diameter.
9. The endoluminal device of claim 1, wherein the fluid inlet
opening is located at a distal end of each member, and the fluid
inlet opening of the inner member is positioned proximal the fluid
inlet opening of the outer member in the assembled
configuration.
10. The endoluminal device of claim 1, wherein the fluid inlet
opening is located at a distal end of each member, and the fluid
inlet opening of the inner member is distally coextensive with the
fluid inlet opening of the outer member in the assembled
configuration.
11. The device of claim 1, wherein each of the inner member and the
outer member comprises an inside surface and an outside surface,
the inner member further comprising at least one impingement area
positioned receive fluid flow to force the outside surface of the
inner member against the inside surface of the outer member in the
assembled configuration.
12. The endoluminal device of claim 1 wherein the inner member
further comprises a leg stump portion leading to the first fluid
exit opening, the outer member further comprises a leg portion
leading to the second fluid exit, and the leg stump portion
protrudes into the leg portion in the assembled configuration.
13. A two-component, bifurcated endoluminal device kit comprising:
a first stent-graft component comprising a trunk portion, a first
long leg portion connected to the trunk portion and a short leg
portion connected to the trunk portion adjacent the long leg
portion; and a second stent-graft component comprising a trunk
portion, a second long leg portion for receiving the short leg, and
a long leg receiving aperture; wherein the first long leg is
adapted to be inserted through the long leg receiving aperture, and
the short leg is adapted to be inserted into the second long leg,
thereby forming a bifurcated endoluminal device.
14. A method for deploying a modular endoluminal device in a
deployment location in a branched lumen comprising a main lumen, a
first branch lumen, and a second branch lumen, the modular
endoluminal device comprising an outer member and an inner member,
the outer member and inner member each comprising a stent-graft, a
fluid inlet opening, a first fluid exit opening, and a second fluid
exit opening, the device having an assembled configuration in which
the inner member fits partially inside the outer member, the method
comprising: (a) inserting a first introducer containing the outer
member into the branched lumen; (b) deploying the outer member with
the inlet opening in the main lumen, the first exit opening aligned
with the first branch lumen, and the second exit opening positioned
in the second branch lumen; (c) inserting a second introducer
containing the inner member into the branched lumen; (d) assembling
the device into the assembled configuration by deploying the inner
member with the inner member inlet opening aligned with the outer
member inlet opening, a portion of the inner member protruding
through the outer member first exit opening and terminating at the
inner member second exit opening, and the inner member first exit
opening aligned with the outer member second exit opening; and (e)
the assembled device receiving endoluminal fluid from the main
lumen through the aligned inner and outer member inlet openings and
discharging the fluid into the first branch lumen through the inner
member second exit opening and into the second branch lumen through
the outer member second exit opening.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/010,628, filed Nov. 7, 2001, the contents
of which are incorporated herein by reference.
TECHNICAL FIELD
[0002] This invention relates generally to endoluminal devices and,
more specifically, to endoluminal devices such as stents, grafts,
and stent-grafts.
BACKGROUND OF THE INVENTION
[0003] A stent is an elongated device used to support an
intraluminal wall. In the case of a stenosis, a stent provides an
unobstructed conduit through a body lumen in the area of the
stenosis. Such a stent may also have a prosthetic graft layer of
fabric or covering lining the inside and/or outside thereof. Such a
covered stent is commonly referred to in the art as an intraluminal
prosthesis, an endoluminal or endovascular graft (EVG), or a
stent-graft. As used herein, however, the term "stent" is a
shorthand reference referring to a covered or uncovered such
device.
[0004] A covered stent may be used, for example, to treat a
vascular aneurysm by removing the pressure on a weakened part of an
artery so as to reduce the risk of rupture. Typically, a stent is
implanted in a blood vessel at the site of a stenosis or aneurysm
endoluminally, i.e. by so-called "minimally invasive techniques" in
which the stent, restrained in a radially compressed configuration
by a sheath or catheter, is delivered by a stent delivery system or
"introducer" to the site where it is required. The introducer may
enter the body from an access location outside the body, such as
through the patient's skin, or by a "cut down" technique in which
the entry blood vessel is exposed by minor surgical means. The term
"proximal" as used herein refers to portions of the stent or
delivery system relatively closer to this access location, whereas
the term "distal" is used to refer to portions farther from the
access location.
[0005] When the introducer has been threaded into the body lumen to
the stent deployment location, the introducer is manipulated to
cause the stent to be ejected from the surrounding sheath or
catheter in which it is restrained (or alternatively the
surrounding sheath or catheter is retracted from the stent),
whereupon the stent expands to a predetermined diameter at the
deployment location, and the introducer is withdrawn. Stent
expansion may be effected by spring elasticity, balloon expansion,
or by the self-expansion of a thermally or stress-induced return of
a memory material to a pre-conditioned expanded configuration.
[0006] Among the many applications for stent-grafts is for
deployment in branching lumen, and more specifically for bifurcated
lumen, such as for repair of abdominal aortic aneurysms (AAA).
Various stent-graft configurations are known in the art for
bifurcated applications, including single-piece ("unitary") designs
and modular designs. Bifurcated devices, however, may involve
special tooling and procedures for their manufacture that result in
high cycle time and low yields, may utilize relatively
large-profile delivery systems or specialized delivery systems, and
in general may be relatively complex in design and implementation.
Modular devices typically also have a risk of leaks in the seals
between the modular components. Thus, it is desirable to provide a
modular endoluminal device, such as a bifurcated stent-graft, that
accommodates a branching flow path yet minimizes drawbacks often
associated with bifurcated and/or modular devices.
SUMMARY OF THE INVENTION
[0007] In accordance with this invention, there is provided an
endoluminal device comprising a first member and a second member.
The first member comprises a first trunk portion, a first
midsection comprising a first opening, and a first leg portion. The
second member comprises a second trunk portion, a second midsection
comprising a second opening, and a second leg portion. The device
has an assembled configuration in which the first member and second
member are interlocked with one another with the second trunk
portion coaxially contained within the first trunk portion, the
second leg portion protruding through the first opening, and the
second opening facing the first leg portion. The second midsection
may further comprise a leg stump portion that protrudes into the
first leg portion of the first member in the assembled
configuration.
[0008] The first member and the second member each may further
comprise a stent having a covering inside, outside, or inside and
outside of the stent. The covering may comprise a textile, a
plastic, or a combination thereof. The first member may comprise an
uncovered portion of the stent, such as an uncovered portion
adapted to be located at an intersection of a renal lumen with the
aorta. The first member may comprise a partial inside covering and
the second member may comprise an outside covering, where the first
member has no inside covering in an interlocking portion adapted to
contact the outside covering of the second member.
[0009] The invention also comprises a modular endoluminal device
for deployment in a body lumen comprising a main lumen, a first
branch lumen, a second branch lumen, and an internal fluid flowing
in a first direction from the main lumen into the first and second
branch lumens. The device comprises a first member for directing
the fluid from the main lumen into the first branch lumen and a
second member for directing the fluid from the main lumen into the
second branch lumen. The device, therefore, accommodates a
branching fluid flow. The first member and the second member are
adapted to interlock together such that the fluid flow forces the
second member against the first member in a sealing relationship.
The second member may comprise at least one impingement area on
which the fluid flow impinges to force the second member against
the first member.
[0010] A system for deployment of an endoluminal device of this
invention may comprise a first introducer for deploying the first
member into a body lumen and having a first profile; and a second
introducer, having a second profile essentially identical to the
first profile, for deploying the second member into the body
lumen.
[0011] The invention also comprises a method of deploying an
endoluminal device of the present invention in a deployment
location in a branched lumen comprising a main lumen, a first
branch lumen, and a second branch lumen. The method comprises the
steps of inserting a first introducer containing the first member
into the branched lumen from a first proximal location, and
deploying the first member with the first trunk portion in the main
lumen and the first leg portion in the first branch lumen. A second
introducer containing the second member is then inserted into the
branched lumen from a second proximal location and the second
member is deployed such that the second member is interlocked with
the first member in the assembled configuration with the second
trunk portion coaxially contained within the first trunk portion,
the second leg portion protruding through the first opening into
the second branch lumen, and the second opening facing the first
leg portion.
[0012] It is to be understood that both the foregoing general
description and the following detailed description are exemplary,
but not restrictive, of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The invention is best understood from the following detailed
description when read in connection with the accompanying drawing,
in which:
[0014] FIG. 1 is a plan view illustration showing an exemplary
embodiment of a device of the present invention;
[0015] FIG. 2 is a longitudinal section view showing another
exemplary embodiment of a device of the present invention;
[0016] FIG. 3 is a cross-sectional illustration of a portion of an
exemplary wall taken across line 3-3 in FIG. 1;
[0017] FIG. 4 is a plan view illustration of an exemplary tapered
member of the present invention; and
[0018] FIG. 5 is a plan view illustration of an exemplary member of
the present invention having a straight leg design.
DETAILED DESCRIPTION OF THE INVENTION
[0019] The invention will next be illustrated with reference to the
figures wherein the same numbers indicate similar elements in all
figures. Such figures are intended to be illustrative rather than
limiting and are included herewith to facilitate the explanation of
the apparatus of the present invention.
[0020] Referring now to FIG. 1, there is shown an exemplary
endoluminal device 10 of this invention. Device 10 may be said to
be "modular" in that it is constructed of more than one
standardized, although not necessarily identical, units. In
particular, device 10 comprises two members 12 and 22. First member
12 comprises a first trunk portion 14, a first midsection 16
comprising a first opening 17, and a first leg portion 18. Second
member 22 comprises a second trunk portion 24, a second midsection
26 comprising a second opening 27, and a second leg portion 28.
First member 12 and second member 22 are adapted to interlock with
one another in an assembled configuration in which second trunk
portion 24 is coaxially contained within first trunk portion 14,
second leg portion 28 protrudes through the first opening 17, and
second opening 27 faces first leg portion 18. First opening 17 may
have a greater area than the second opening 27. The shape of first
opening 17 may generally be the shape of the outer periphery of the
portion of second member 22 which extends through the opening. The
shape of second opening 27 may generally be suitable to be an
extension of the flow path defined by first member 12.
[0021] Referring now to FIG. 2, there is shown another exemplary
endoluminal device 100. Endoluminal device 100 also comprises first
and second members 112 and 122, each having respective trunk
portions 14 and 24, midsections 16 and 26, openings 17 and 27, and
leg portions 18 and 28, similar to members 12 and 22. Second
midsection 26 of second modular member 122, however, further
comprises a leg stump portion 30 opposite leg portion 28. Leg stump
portion 30 has an open end 32 comprising opening 27. Leg stump
portion 30 is adapted to protrude into the first leg portion 18
when first member 112 and second member 122 are interlocked. Leg
stump portion 30 serves to further stabilize second member 122
within first member 112, and may extend into leg portion 18 any
suitable length.
[0022] Device 100 shown in FIG. 2 further comprises a seal ring 40
in trunk portion 14 of first member 112. Seal ring 40 may comprise
any circumferential area of the device having greater sealing
properties than the surrounding areas of the device. For example,
device 100 may comprise a stent that exerts a certain radial force
per unit length throughout the stent, but the seal ring portion
exerts a greater radial force. Alternatively, the stent may have a
covering comprising one type of material over much of the stent
surface area and a different material in the area of the seal ring.
For example, the material in the seal ring may comprise a knit
material with a heavier texture than the surrounding material. The
greater sealing properties of the underlying stent may result from
the use of a first stent pattern, such as a woven mesh with a first
amount of open area between filaments, in the area surrounding the
seal ring, and a second stent pattern, such as a more densely woven
mesh with a second, lesser amount of open area between filaments,
in the seal ring itself. Other embodiments of seal rings suitable
for use in this invention are disclosed in U.S. patent application
Ser. No. 09/898,936 entitled IMPLANT HAVING IMPROVED FIXATION TO A
BODY LUMEN AND METHOD FOR IMPLANTING THE SAME by Paul DiCarlo and
filed on Jul. 3, 2001, incorporated herein by reference. Any seal
ring embodiment may be used, however, such as but not limited to
embodiments described in U.S. Pat. No. 5,575,818 to Pinchuk,
incorporated herein by reference. Seal rings may be located
anywhere along the body of the first or second member where
desired. For example, seal rings may be particularly useful at the
distal or proximal ends of the members for sealing against the
lumen wall, as illustrated by seal ring 40. Seal rings may also be
useful in the first member opening 17 or on the corresponding
portion of second member 22 or 122 that is contacted by opening 17,
to facilitate a stronger seal at the interface between the first
and second members.
[0023] The respective members of endoluminal devices 10 and 100 may
comprise a stent 42 having at least a partial covering 44 inside,
outside, or inside and outside of the stent. The stent itself may
be any type of stent known in the art, such as a filamentary stent
or a stent fabricated by laser or otherwise cutting a preformed
tube or sheet to be rolled into a tube. The stent may also comprise
any stent material known in the art, such as a plastically
deformable material such as stainless steel, or a superelastic
material or shape-memory material, such as nitinol, or some
combination thereof. Accordingly, the stent may be balloon
expandable, self-expanding, or some combination thereof. The stent
construction is not limited, however, to any particular design,
architecture, fabrication method, deployment method, or
materials.
[0024] Covering 44 may comprise a textile, such as a knit or woven
textile, a plastic, such as ePTFE or urethane, or a combination
thereof. Referring now to FIG. 3, there is shown a cross-section of
an exemplary device taken across line 3-3 in FIG. 1, with the inner
surface of the device at the bottom and the outer surface of the
device at the top. As shown in FIG. 3, the device may comprise a
stent 42 have both an outside ePTFE covering 50 and an inside ePTFE
covering 52. The outside ePTFE covering 50 may further comprise a
textile covering 54, such as a knit or woven covering as shown in
FIG. 3. The textile covering may, for example, comprise stretchable
PET or polyester yarn. In an alternative embodiment, the stent may
have no inner ePTFE covering 52 or no outer textile covering 54.
Any combination of the coverings, however, may be present.
[0025] The covering configuration may be the same throughout each
member, or may vary in different areas according to need. For
example, first member 112 may comprise an inside covering 52 and
second member 122 may comprise an outside covering 50. The
interlocking portion 60 of first member 12 that is adapted to
contact the outside covering of the second member, however, may
have no inside covering.
[0026] As shown in FIG. 2, first member 112 of device 100 may
further comprise an uncovered portion 56 of stent 42. Uncovered
portion 56 of stent 42 may comprise a hexagonal cell design,
wherein each cell 46 typically has a pointed apex section 48 at
opposite ends, or any design known in the art. As shown in FIG. 2,
cells 46 are end cells that have pointed apex sections 48 at the
proximal end and flat distal ends 47, providing pentagons rather
than hexagons. The covered portion of stent 42 may comprise the
same geometric pattern or a different pattern as the end geometry.
For endoluminal device 100, which is shown mounted in a branched
lumen, such as the aorta, uncovered portion 56 may be located at an
intersection of branch lumens 71A and 71B, such as the intersection
of the renal arteries with the aorta. Such a configuration prevents
the stent covering from blocking blood flow to the branch arteries.
Thus, as shown in FIG. 2, second trunk portion 24 of second member
122 is not distally coextensive with first trunk portion 14 of
first member 112. That is, first trunk portion 14 comprises the
uncovered portion 56 which extends further distally than trunk
portion 24. In other designs, however, the two trunk portions may
end at the same distal location.
[0027] As shown in FIG. 1, each member 12 and 22 has a tapered
diameter throughout its entire length, tapering from a larger
diameter at the distal end to a smaller diameter at the proximal
end. In other designs, however, at least the leg portions may have
a constant diameter, as shown in FIG. 2. The overall member design
may differ for a tapering leg design as compared to a straight leg
design. For example, referring now to FIGS. 4 and 5, there are
shown a first member 212 with a tapered leg design and a first
member 312 with a straight leg design, respectively. Opening 217 in
tapered-leg first member 212 has essentially an tear-drop or egg
shape, and the body of first member 212 has a smooth curvature.
Opening 317 in straight-leg first member 312 has an almost
triangular projection, whereas the body of first member 312
comprises three distinct sections, a larger diameter trunk portion
314, a tapered midsection 316, and a smaller diameter leg portion
318.
[0028] One advantage of the present invention is that the modular
components may be similar in size and profile. For example, any
endoluminal device typically has a compressed configuration and an
expanded configuration, and each device has a respective diameter
or profile in each configuration. For many bifurcated modular
devices known in the art, the individual modular members may differ
in compressed profile significantly enough that differently sized
delivery systems may be required to deploy each member. As used
herein, the term "profile" refers to the largest diameter of any
portion of a device in a compressed configuration. For the design
shown in FIG. 1, however, each of the modular members has a
similar, if not identical, compressed profile, and can thus be
introduced into the body using similarly sized delivery systems.
Furthermore, because each member 12 and 22 comprises only a trunk
section and a single leg, the delivery system may be relatively
smaller than a delivery system designed to deploy a bifurcated
device having a trunk section and at least a portion of two legs.
Members 12 and 22 do not have a profile any larger than any
non-branching device having a diameter the size of the diameter of
trunk portion 14, and thus do not require a delivery system any
larger than for such a non-branching device.
[0029] The similarity in profile and geometry of first member 12
and second member 22 also means that they can be constructed using
similar tooling, and the simplicity of both means that they can be
constructed without the need for any of the special or complex
tooling typically required for bifurcated systems. The simplicity
of design also makes the members relatively easier to cover using
existing lamination and bonding techniques, resulting in reduced
cycle time and higher yields as compared to traditional bifurcated
devices.
[0030] The interlocking design of the device of this invention also
provides certain advantages. As shown in FIG. 2, the device is
typically deployed in a body lumen comprising a main lumen 70, a
first branch lumen 72, a second branch lumen 74, and an internal
fluid 76 flowing in a first direction along arrow A from the main
lumen into the first and second branch lumens. First member 112
directs fluid 76 from main lumen 70 into first branch lumen 72 and
second member 22 directs the fluid from the main lumen into second
branch lumen 74. The shear force of fluid 76 flowing in the
direction of arrow A tends to force second member 22 against first
member 12 in a sealing relationship. That is, the fluid pressure
wedges second member 22 further into opening 17 of member 12,
strengthening the seal between opening 17 and the member 22. In
particular, fluid 76 impinges against inner crotch 78 in second
member 122 and adds to the force that interlocks members 112 and
122 together. In a design without a leg stump 30, such as the
design shown in FIG. 1, there is a sharper transition between the
midsection and the legs that may provide more advantageous
hemodynamics because there is no dead space where clots can
form.
[0031] The endoluminal device of the present invention may be
introduced by any known surgical procedure. Preferably, the device
is introduced endoluminally, by first introducing first member 12
to its location, in a proper radial orientation using radiopaque
markers such that first opening faces second branch lumen 74 (as
shown in FIG. 2). Then, second member 22 is deployed by directing a
second introducer through first opening 17. In the embodiment shown
in FIG. 1, second member 22 can be deployed directly to its
ultimate location to be desired. In the embodiment shown in FIG. 2,
however, it is desirable to initially deploy second member 122 at a
location slightly upstream of its ultimate resting place to ensure
that leg stump 30 leads to first branch lumen 32. Endoluminal fluid
flow in the direction of arrow A may then move second member 122
proximally until crotch 78 of second member 122 abuts first member
112.
[0032] The deployed device may be inspected using fluoroscopy,
optionally following injection of a contrast media, as is known in
the art, to ascertain that the second member 122 has seated
properly in abutment with first member 112. If necessary,
mechanical means, such as but not limited to a hook or tethers
attached to the second member, may be used to adjust the position
of second member 122. As noted above, the stent may be deployed by
any type of expansion known in the art. Regardless of how the stent
is initially deployed, balloon devices may be used to model the
members into place to conform to the topography of the lumen, as is
known in the art.
[0033] First member 112 may be introduced from a proximal location
downstream of the deployment location through first branch lumen
72, and second member 122 introduced from a proximal location
through branch lumen 74, or one or both members may be introduced
through main lumen 70 from proximal locations upstream of the
deployment location.
[0034] Furthermore, although illustrated and described herein with
reference to certain specific embodiments, the present invention is
nevertheless not intended to be limited to the details shown.
Rather, various modifications may be made in the details within the
scope and range of equivalents of the claims and without departing
from the spirit of the invention.
* * * * *