U.S. patent application number 13/295861 was filed with the patent office on 2012-05-24 for sleeves for expandable medical devices.
Invention is credited to Edward E. Shaw.
Application Number | 20120130475 13/295861 |
Document ID | / |
Family ID | 46065051 |
Filed Date | 2012-05-24 |
United States Patent
Application |
20120130475 |
Kind Code |
A1 |
Shaw; Edward E. |
May 24, 2012 |
SLEEVES FOR EXPANDABLE MEDICAL DEVICES
Abstract
The present disclosure describes treatment of the vasculature of
a patient with an expandable implant. The implant is constrained to
a reduced delivery profile for delivery within the vasculature by
at least one sleeve. The implant may be constrained to other
diameters, such as an intermediate configuration having a diameter
larger than the delivery profile and smaller than the deployment
diameter. The sleeves may be expanded, allowing for expansion of
the diameter of the expandable implant, by disengaging a coupling
member from the sleeve or sleeves from outside of the body of the
patient. The expandable implant may comprise a number of side
branch fenestrations or fenestratable portions.
Inventors: |
Shaw; Edward E.; (Flagstaff,
AZ) |
Family ID: |
46065051 |
Appl. No.: |
13/295861 |
Filed: |
November 14, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61414253 |
Nov 16, 2010 |
|
|
|
Current U.S.
Class: |
623/1.12 ;
623/1.35 |
Current CPC
Class: |
A61F 2002/9511 20130101;
A61F 2/82 20130101; A61F 2250/0098 20130101; A61F 2002/061
20130101; A61F 2/958 20130101; A61F 2/97 20130101; A61F 2/954
20130101; A61F 2250/0067 20130101; A61F 2/07 20130101 |
Class at
Publication: |
623/1.12 ;
623/1.35 |
International
Class: |
A61F 2/84 20060101
A61F002/84 |
Claims
1. A device for treating a vessel comprising: an expandable stent
graft having a main lumen and a target portion; a primary sleeve
wrapped circumferentially around the expandable stent graft,
wherein the primary sleeve comprises a sheet of material having
first and second major surfaces and a plurality of openings
extending from the first major surface to the second major surface;
and a primary coupling member cooperating with the openings for
releasably coupling portions of the sheet to one another to
constrain the expandable stent graft in a collapsed configuration,
wherein the primary sleeve includes a lateral opening proximate to
the target portion.
2. The device of claim 1, wherein the target portion comprises a
side branch fenestration.
3. The device of claim 1, wherein the target portion comprises a
fenestratable portion that is punctured to form a side branch
fenestration.
4. The device of claim 1, wherein the primary sleeve constrains the
expandable stent graft in the collapsed configuration for delivery
within the vessel.
5. The device of claim 1, wherein upon release of the primary
sleeve, the target portion is exposed between opposing edges of the
sheet of material.
6. The device of claim 1, wherein edges of the first and second
major surfaces through which the plurality of openings extend
comprise radiopaque markers.
7. The device of claim 1, wherein the target portion includes a
drug eluting element.
8. The device of claim 4, further comprising a secondary coupling
member, wherein the secondary coupling member constrains the
expandable stent graft in an intermediate configuration, the
intermediate configuration comprising a diameter larger than the
diameter of the collapsed configuration and smaller than the
diameter of the expandable stent graft in an unconstrained
diameter.
9. A device for treatment of a vessel comprising: an expandable
implant having a main lumen and at least one target portion; at
least two sheets of material, each wrapped circumferentially around
the expandable implant forming at least two adjacent tubes; each
tube having at least one tube end adjacent to another tube end;
each sheet having first and second major surfaces and a plurality
of openings extending from the first major surface to the second
major surface; and a coupling member cooperating with the openings
for releasably coupling portions of each sheet together to
constrain the expandable implant in a collapsed configuration.
10. The device of claim 9, wherein upon disengagement of the
coupling member and expansion of the expandable implant, the at
least one target portion is positioned between one tube end and the
other adjacent tube end.
11. The device of claim 9, further comprising a primary sleeve
extending around the at least two sheets of material and the
expandable implant for constraining the device to a collapsed
configuration suitable for endoluminal delivery.
12. The device of claim 9, wherein the at least two sheets of
material limit expansion of the device to an intermediate
configuration, in which the diameter of the expandable implant is
larger than the collapsed configuration suitable for endoluminal
deployment and smaller than the expandable implant in an
unconstrained diameter.
13. The device of claim 9, wherein at least two of the sheets of
material have two opposed longitudinally extending edges.
14. The device of claim 13, wherein the target portion is disposed
between the opposed longitudinally extending edges.
15. The device of claim 9, wherein the target portion comprises a
side branch fenestration.
16. The device of claim 9, wherein at least one edge of at least
one of the sheets of material comprises a radiopaque material.
17. The device of claim 9, wherein the target portion comprises a
fenestratable portion.
18. The device of claim 9, wherein the target portion comprises a
therapeutic agent eluting element disposed beneath at least one of
the sheets of material such that once the coupling member of the at
least one of the sheets of material has been disengaged a
therapeutic agent is exposed.
19. A device for treatment of a vessel comprising: an expandable
implant having a main lumen and at least one target portion; at
least two sleeves; a collapsed configuration, wherein each of the
at least two sleeves comprise a sheet of material wrapped
circumferentially around the expandable implant forming a tube
having at least one tube end adjacent to another tube end; each
sheet having first and second major surfaces and a plurality of
openings extending from the first major surface to the second major
surface; and a coupling member cooperating with the openings for
releasably coupling portions of each sheet together to constrain
the expandable implant in a collapsed configuration; and an
expanded configuration, wherein upon disengagement of the coupling
member, the expandable implant is expanded and the at least one
target portion is positioned between one tube end and the other
adjacent tube end.
20. The device of claim 19 further comprising: an intermediate
configuration, wherein the device further comprises a primary
sleeve surrounding the expandable implant and at least two sleeves,
wherein upon the of the primary sleeve the expandable implant
expands to an intermediate configuration which is greater than the
diameter of the collapsed configuration and less than the diameter
of the expanded configuration.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional Patent
Application No. 61/414,253, entitled "SEGMENTED CONSTRAINING
SLEEVES FOR EXPANDABLE MEDICAL DEVICES" filed Nov. 16, 2010, which
is hereby incorporated by reference in its entirety.
BACKGROUND
[0002] 1. Field
[0003] The present disclosure relates generally to the
transcatheter delivery and remote deployment of implantable medical
devices.
[0004] 2. Discussion of the Related Art
[0005] Endoluminal devices used to treat a treatment area of the
vasculature of a patient are typically delivered via a catheter
assembly. Such endoluminal devices may comprise, for example,
expandable implants. One common type of expandable implant is the
stent graft. Stent grafts may have a reduced diameter, collapsed
configuration for delivery to the patient's vasculature, then be
expanded once the treatment area of the vasculature is reached.
Stent grafts may be constrained in the collapsed configuration by a
biocompatible sleeve.
[0006] While the use of such sleeves provides a convenient way to
constrain the stent graft, sleeves may give rise to other problems
or issues. For example, it may be difficult to position a stent
graft that is constrained by a biocompatible sleeve for implanting
within the treatment area of the vasculature. Further, it may be
difficult to remove or expand the sleeve to allow for expansion of
the stent graft. Finally, orienting or locating a
sleeve-constrained stent graft after it has been expanded may be
difficult. These issues can be exaggerated when a
sleeve-constrained stent graft is configured with side branch
fenestrations (or side branch portals) or fenestratable portions
configured for the attachment of side branches.
[0007] Therefore, devices, systems and methods that facilitate
improved preparation of a sleeve-constrained expandable implant for
delivery, accurate delivery of the implant, and correct orientation
and position of the implant would be useful and desirable.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The accompanying drawings are included to provide a further
understanding of the disclosure and are incorporated in and
constitute a part of this specification, illustrate embodiments of
the disclosure, and together with the description serve to explain
the principles of the disclosure, wherein:
[0009] FIG. 1 is a perspective view of a catheter assembly having a
medical device constrained in a delivery profile by a plurality of
tubular sleeves;
[0010] FIG. 2 is a perspective view of a catheter assembly having
an expanded medical device showing the positions of the sleeves
relative to side branch fenestrations of the medical device;
[0011] FIG. 3 is a perspective view of a catheter assembly having a
medical device constrained in a delivery profile by angularly
displaced sleeves;
[0012] FIG. 4 is a perspective view of a catheter assembly having
an expanded medical device showing the positions of the angularly
displaced sleeves.
[0013] FIGS. 5A and B are, respectively, perspective and axial
views of a catheter assembly having a medical device constrained in
a delivery profile, and FIG. 5C is an axial view of the catheter
assembly having a medical device constrained in an intermediate
configuration;
[0014] FIG. 6 is a perspective view of a catheter assembly having a
medical device constrained in a delivery profile by a tubular
sleeve; and
[0015] FIGS. 7A and B are, respectively, perspective and axial
views of a catheter assembly having a medical device constrained in
a delivery profile, and FIG. 7C is a perspective view of the
catheter assembly having a medical device constrained in an
intermediate configuration.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0016] While the present disclosure describes a number of
embodiments, it will be understood that the disclosure is not
limited to these embodiments. Instead, it is intended to cover all
alternatives, modifications, and equivalents as may be included
within the spirit and scope of the disclosure as described and
claimed.
[0017] Various embodiments of the present disclosure comprise a
catheter assembly configured to deliver an expandable implant to a
treatment area of the vasculature of a patient. In accordance with
embodiments of the disclosure, an expandable implant is constrained
by one or more sleeves. When the sleeves are expanded or removed,
one or more target portions of the expandable implant can be
exposed. In various embodiments, the target portion or portions
comprise side branch fenestrations or fenestratable portions. Such
target portions may be revealed between adjacent sleeves or between
the edges of a single sleeve.
[0018] With initial reference to FIG. 1, a catheter assembly 100 in
accordance with the present disclosure comprises an expandable
implant 102. Expandable implant 102 may comprise any endoluminal
device suitable for delivery to the treatment area of a
vasculature. Such devices may include, for example, stents, grafts,
and stent grafts.
[0019] In various embodiments, expandable implant 102 comprises a
stent graft. Conventional stent grafts are designed to dilate from
the diameter of the delivery profile, through a range of
intermediary diameters, up to a maximal, pre-determined functional
diameter, and generally comprise one or more stent components with
one or more graft members displaced over and/or under the
stent.
[0020] In various embodiments, expandable implant 102 comprises one
or more stent components made of nitinol and a graft member made of
ePTFE. However, and as discussed below, any suitable combination of
stent component(s) and graft member(s) is within the scope of the
present disclosure.
[0021] For example, stent components can have various
configurations such as, for example, rings, cut tubes, wound wires
(or ribbons) or flat patterned sheets rolled into a tubular form.
Stent components can be formed from metallic, polymeric or natural
materials and can comprise conventional medical grade materials
such as nylon, polyacrylamide, polycarbonate, polyethylene,
polyformaldehyde, polymethylmethacrylate, polypropylene,
polytetrafluoroethylene, polytrifluorochlorethylene,
polyvinylchloride, polyurethane, elastomeric organosilicon
polymers; metals such as stainless steels, cobalt-chromium alloys
and nitinol and biologically derived materials such as bovine
arteries/veins, pericardium and collagen. Stent components can also
comprise bioresorbable materials such as poly(amino acids),
poly(anhydrides), poly(caprolactones), poly(lactic/glycolic acid)
polymers, poly(hydroxybutyrates) and poly(orthoesters). Any
expandable stent component configuration which may be delivered by
a catheter is in accordance with the present disclosure.
[0022] Moreover, potential materials for graft members include, for
example, expanded polytetrafluoroethylene (ePTFE), polyester,
polyurethane, fluoropolymers, such as perfouorelastomers and the
like, polytetrafluoroethylene, silicones, urethanes, ultra high
molecular weight polyethylene, aramid fibers, and combinations
thereof. Other embodiments for a graft member material can include
high strength polymer fibers such as ultra high molecular weight
polyethylene fibers (e.g., Spectra.RTM., Dyneema Purity.RTM., etc.)
or aramid fibers (e.g., Technora.RTM., etc.). The graft member may
include a bioactive agent. In one embodiment, an ePTFE graft
includes a carbon component along a blood contacting surface
thereof. Any graft member which may be delivered by a catheter is
in accordance with the present disclosure.
[0023] In various embodiments, a stent component and/or graft
member may comprise a therapeutic coating. In these embodiments,
the interior or exterior of the stent component and/or graft member
can be coated with, for example, a CD34 antigen. Additionally, any
number of drugs or therapeutic agents may be used to coat the graft
member, including, for example heparin, sirolimus, paclitaxel,
everolimus, ABT-578, mycophenolic acid, tacrolimus, estradiol,
oxygen free radical scavenger, biolimus A9, anti-CD34 antibodies,
PDGF receptor blockers, MMP-1 receptor blockers, VEGF, G-CSF,
HMG-CoA reductase inhibitors, stimulators of iNOS and eNOS, ACE
inhibitors, ARBs, doxycycline, and thalidomide, among others.
[0024] In various embodiments, expandable implant 102 may comprise
a radially collapsed configuration suitable for delivery to the
treatment area of the vasculature of a patient. Expandable implant
102 may be constrained in a radially collapsed configuration and
mounted onto a delivery device such as catheter shaft 110. The
diameter of the expandable implant 102 in the collapsed
configuration is small enough for the implant to be delivered
through the vasculature to the treatment area. In various
embodiments, the diameter of the collapsed configuration is small
enough to minimize the crossing profile of catheter assembly 100
and reduce tissue damage to the patient. In the collapsed
configuration, the expandable implant 102 may be guided by catheter
shaft 110 through the vasculature.
[0025] In various embodiments, expandable implant 102 may comprise
a radially expanded configuration suitable for implanting the
device in the treatment area of a patient's vasculature. In the
expanded configuration, the diameter of expandable implant 102 may
be approximately the same as the vessel to be repaired. In other
embodiments, the diameter of expandable implant 102 in the expanded
configuration may be slightly larger than the vessel to be treated
to provide a traction fit within the vessel.
[0026] In various embodiments, expandable implant 102 may comprise
a self-expandable device, such as a self-expandable stent graft.
Such devices dilate from a radially collapsed configuration to a
radially expanded configuration when unrestrained. In other
embodiments, expandable implant 102 may comprise a device that is
expanded with the assistance of a secondary device such as, for
example, a balloon. In yet other embodiments, catheter assembly 100
may comprise a plurality of expandable implants 102. The use of a
catheter assembly with any number of expandable implants is within
the scope of the present disclosure.
[0027] Various medical devices in accordance with the disclosure
comprise a sleeve or multiple sleeves. The sleeve or sleeves may
constrain an expandable implant device in a collapsed configuration
for endoluminal delivery of the implant to a treatment portion of
the vasculature of a patient. For the purposes of the disclosure,
the term "constrain" may mean (i) to limit the expansion, either
through self-expansion or assisted by a device, of the diameter of
an expandable implant or (ii) to cover or surround but not
otherwise restrain an expandable implant (e.g., for storage or
biocompatibility reasons and/or to provide protection to the
expandable implant and/or the vasculature).
[0028] After deployment, the sleeve or sleeves may be removed in
order to allow the expandable implant to expand to its functional
diameter and achieve the desired therapeutic outcome. The sleeve or
sleeves can remain implanted while not interfering with the
expandable implant.
[0029] In various embodiments, an expandable implant is constrained
by a single sleeve which circumferentially surrounds the expandable
implant. For example, with reference to FIG. 6, catheter assembly
600 comprises a sleeve 604. In various embodiments, sleeve 604
circumferentially surrounds expandable implant 602 and constrains
it in a collapsed configuration, in which the diameter is less than
the diameter of the unconstrained implant. For example, sleeve 604
may constrain expandable implant 602 in a collapsed configuration
for delivery within the vasculature.
[0030] In other embodiments, an expandable implant is constrained
by a plurality of sleeves which circumferentially surround the
expandable implant. For example, with reference to FIG. 1, catheter
assembly 100 comprises sleeves 104a, 104b, and 104c. Each sleeve
104 is distinct and separate from the other two sleeves, and each
concentrically surrounds a portion of expandable implant 102.
[0031] In various embodiments, sleeves 104a, 104b, and 104c may be
coupled to each other, such as, by adhesive bonding, tethering, or
any other form of coupling. For example, with reference to FIG. 1,
sleeves 104a, 104b, and 104c may be coupled together by tethers 140
and 142 such that sleeves 104a, 104b, and 104c act as one
individual sleeve. Tethers 140 and 142 may comprise any of the
suitable materials of the present disclosure, such as the same
material of which sleeves 104a, 104b, and 104c are made. Indeed, in
some embodiments, a single sleeve may be cut or perforated in such
a manner as to create individual sleeves 104a, 104b, and 104c, but
leaving tethers 140 and 142. In some embodiments, described in
greater detail below, lateral openings are cut in a single sleeve
such that the single sleeve acts as multiple sleeves (e.g., by
relatively large sizing of lateral openings, etc.). In various
configurations, sleeves 104a, 104b, and 104c being coupled together
in some manner may facilitate easier removal of the sleeves after
deployment of expandable implant 102 and/or or ensure sleeves 104a,
104b, and 104c stay implanted as one individual sleeve.
[0032] In such configurations, each distinct sleeve may be formed
as individual sleeves, or may be created by forming a single sleeve
around an expandable implant and creating individual sleeves from
the single sleeve by, for example, cutting the single sleeve into
individual sleeves.
[0033] As a further example, with reference to FIG. 3, catheter
assembly 300 comprises sleeves 304a and 304b. Each sleeve 304 is
distinct and separate from the other sleeve, and each
concentrically surrounds a portion of expandable implant 302.
[0034] In various embodiments, sleeves can be tubular and serve to
constrain an expandable implant. In such configurations, sleeves
are formed from a sheet of one or more materials wrapped or folded
about the expandable implant. In the case where multiple sleeves
are used to constrain an expandable implant, each sleeve can
comprise at least one sleeve end adjacent to another sleeve end.
While the illustrative embodiments herein are described as
comprising one or more tubular sleeves, sleeves of any non-tubular
shape that corresponds to an underlying expandable implant or that
are otherwise appropriately shaped for a given application are also
within the scope of the present disclosure.
[0035] In various embodiments, sleeves are formed by wrapping or
folding the sheet of material(s) such that two parallel edges of
the sheet are substantially aligned. Said alignment may or may not
be parallel to or coaxial with the catheter shaft of a catheter
assembly. In various embodiments, the edges of the sheet of
material(s) do not contact each other.
[0036] In various embodiments, the edges of the sheet of
material(s) do contact each other and are coupled with a coupling
member, as described below, an adhesive, etc. In various other
embodiments, the edges of the sheet of material(s) are aligned so
that the edges of the same side of the sheet or sheets (e.g., the
front or back of the sheet) are in contact with each other. In
still other embodiments, the edges of opposite sides of the sheet
of material(s) are in contact with each other, such that the edges
overlap each other, such that a portion of one side of the sheet is
in contact with a portion of the other side. Said another way, the
front of the sheet may overlap the rear of the sheet, or vice
versa.
[0037] In various embodiments, sleeves comprise materials similar
to those used to form a graft member. For example, a precursor
flexible sheet used to make the sleeve can be formed from a
flattened, thin wall ePTFE tube. The thin wall tube can incorporate
"rip-stops" in the form of longitudinal high strength fibers
attached or embedded into the sheet or tube wall.
[0038] The sheet of material(s) used to form the sleeve(s) may
comprise a series of openings, such that the openings extend from
one edge of the sheet to the other. In such configurations, a
coupling member can be woven or stitched through the series of
openings in the sheet of material(s), securing each of the two
edges together and forming a tube.
[0039] In various embodiments, the coupling member may comprise a
woven fiber. In other embodiments, the coupling member may comprise
a monofilament fiber. Any type of string, cord, thread, fiber, or
wire which is capable of maintaining a sleeve in a tubular shape is
within the scope of the present disclosure.
[0040] In various embodiments, a single coupling member may be used
to constrain the diameter of one or more sleeves. For example, with
reference to FIG. 6, a coupling member 614 is woven through
openings in a single sleeve 604 to maintain the configuration of
sleeve 604 around expandable implant 602. In another example, with
reference to FIG. 1, a single coupling member 114 is woven through
openings in a plurality of sleeves 104a, 104b, and 104c.
[0041] In other embodiments, multiple coupling members may be used
to constrain the diameter of one or more sleeves. For example, with
reference to FIG. 3, coupling members 314a and 314b are used to
maintain the configuration of sleeves 304a and 304b, respectively,
around expandable implant 302. The use of any number of coupling
members in conjunction with a single sleeve or any number of
sleeves is within the scope of the present disclosure.
[0042] In various embodiments, once a suitable expandable implant
is in a collapsed configuration, the expandable implant may be
deployed within the vasculature of a patient. An expandable implant
in a collapsed configuration may be introduced to a vasculature and
directed by a catheter assembly to a treatment area of the
vasculature. Once in position in the treatment area of the
vasculature, the expandable implant may be expanded to an expanded
configuration.
[0043] In various embodiments, when the expandable implant is in
position within the vasculature, the coupling member or members can
be disengaged from the sleeve or sleeves from outside of the body
of the patient, which allows the sleeve(s) to open and the
expandable implant to expand. As discussed above, the expandable
implant may be self-expanding, or the implant may be expanded by a
device, such as a balloon.
[0044] The coupling member or members may be disengaged from the
sleeve or sleeves by a mechanical mechanism operated from outside
of the body of the patient. For example, the member or members may
be disengaged by applying sufficient tension to the member or
members. In another example, a dial or rotational element may be
attached to the coupling member or members outside of the body.
Rotation of the dial or rotational element may provide sufficient
tension to disengage the coupling member or members.
[0045] In other configurations, coupling member or members may be
disengaged by non-mechanical mechanisms, such as, for example,
dissolution, by providing ultrasonic energy. In such
configurations, sufficient ultrasonic energy is provided to
coupling member or members to disengage them from the sleeve or
sleeves.
[0046] In various embodiments, disengaging a single coupling member
which closes a single sleeve from the sleeve allows the expandable
device to be expanded. For example, with reference to FIG. 6,
catheter assembly 600 may be used to deliver an implant expandable
implant 602 to a treatment area of a vasculature. Expandable
implant 602 has a collapsed configuration for delivery, and sleeve
604 circumferentially surrounds expandable implant 602 and is held
closed by coupling member 614. Once expandable implant 602 is in
position relative to the treatment area, coupling member 614 is
disengaged from sleeve 604 and sleeve 604 is released, allowing
expandable implant 602 to expand to a larger diameter.
[0047] In other embodiments, a single coupling member closing a
plurality of sleeves is disengaged from the plurality of sleeves to
allow an expandable device to be expanded. For example, with
reference to FIG. 1, catheter assembly 100 comprises a plurality of
sleeves 104 surrounding expandable implant 102. Each sleeve 104 is
oriented on the longitudinal axis of catheter shaft 110 such that
the portion of each sleeve 104 stitched together by a single
coupling member 114 is substantially aligned with each other.
However, any degree of relative angular displacement between the
plurality of sleeves 304 is within the scope of the present
disclosure.
[0048] Upon disengagement of coupling member 114 from the most
distal sleeve 104c, the portion of expandable implant 102
constrained by sleeve 104c may expand to a larger diameter. As
previously discussed, expandable implant 102 may be
self-expandable, or may expand with the aid of a device such as a
balloon.
[0049] Coupling member 114 is then further disengaged, allowing the
portion of expandable implant 102 constrained by the next most
distal sleeve 104b to expand to a larger diameter. The remainder of
coupling member 114 may then be disengaged, and the next most
distal sleeve 104a is opened, allowing expandable implant 102 to
expand to its expanded configuration the along the remainder of its
longitudinal axis. Although the disengagement of coupling member
114 is described as beginning at the distal end of expandable
implant 102 and progressing toward the proximal end, any order of
disengagement of coupling member or members from a sleeve or
multiple sleeves is within the scope of the present disclosure, for
example proximal to distal, middle to ends, ends to middle,
etc.
[0050] In other embodiments, multiple coupling members are used in
conjunction with a single sleeve or multiple sleeves. For example,
with reference to FIG. 3, catheter assembly 300 comprises at least
two sleeves 304a and 304b. Sleeves 304a and 304b are held closed by
coupling members 314a and 314b, respectively. In various
embodiments, sleeves 304a and 304b may be oriented such that the
portions of the sleeves secured by coupling members 314a and 314b
are angularly displaced relative to each other by about 180
degrees. In other embodiments, the portions of the sleeves secured
by coupling members 314a and 314b are angularly displaced relative
to each other by more than about zero degrees and less than about
180 degrees. Any degree of relative angular displacement between
the plurality of sleeves 304 is within the scope of the present
disclosure.
[0051] In such configurations as illustrated in FIG. 3, coupling
members 314a and 314b may be disengaged separately to open sleeves
304a and 304b. Once both sleeves 304 have been opened, expandable
implant 302 may be expanded to an expanded configuration.
[0052] In various embodiments of the present disclosure, an
expandable implant may further comprise an intermediate
configuration. In the intermediate configuration, the diameter of
the expandable implant is constrained in a diameter smaller than
the expanded configuration and larger than the collapsed
configuration. In such embodiments, the expandable implant may be
expanded from the collapsed configuration to the intermediate
configuration once the implant has been delivered near the
treatment area of the vasculature of a patient. The intermediate
configuration may, among other things, assist in properly orienting
and locating the expandable implant within the treatment area of
the vasculature.
[0053] In various embodiments, an expandable implant may be
concentrically surrounded by at least two sleeves having different
diameters. In such configurations, one or more primary sleeves
constrain the expandable implant in a delivery profile. Once the
primary sleeve is opened, one or more secondary sleeves constrain
the expandable implant in an intermediate configuration. As
discussed above, the expandable implant may be self-expanding, or
the implant may be expanded by a device, such as a balloon.
[0054] For example, with reference to FIGS. 7A-7C, a catheter
assembly 700 comprises an expandable implant 702 and secondary
sleeves 704a and 704b. Secondary sleeves 704a and 704b constrain
expandable implant 702 to an intermediate configuration. Secondary
sleeves 704a and 704b are held in position around expandable
implant 702 by coupling members 714a and 714b, respectively.
[0055] Catheter assembly 700 further comprises a primary sleeve
718, which constrains expandable implant 702 in a collapsed
configuration for delivery to the vasculature of a patient. Primary
sleeve 718 is held in position around expandable implant 702 by
primary coupling member 722.
[0056] Once expandable implant 702 is sufficiently close to the
treatment area of the vasculature, primary coupling member 722 is
disengaged from primary sleeve 718, which releases primary sleeve
718 and allows expanded implant 702 to expand to a larger diameter.
After primary sleeve 718 has been expanded, secondary sleeves 704a
and 704b constrain the expandable implant 702 in the intermediate
configuration. In the intermediate configuration, expandable
implant 702 may be oriented and adjusted to a final desirable
location within the treatment area of the vasculature.
[0057] In other embodiments of the present disclosure, a single
sleeve may be used to constrain the expandable implant in both a
collapsed configuration and an intermediate configuration. For
example, with reference to FIGS. 5A-5B, catheter assembly 500
comprises an expandable implant 502, a monosleeve 504, a primary
coupling member 516 and a secondary coupling member 514.
[0058] Monosleeve 504 further comprises a plurality of intermediate
holes 506. In this configuration, secondary coupling member 514 is
stitched or woven through intermediate holes 506, constricting
monosleeve 504 and expandable implant 502 to the diameter of an
intermediate configuration. In the intermediate configuration, the
diameter of expandable implant 502 is less than the expanded
diameter and larger than the diameter of the collapsed
configuration.
[0059] Monosleeve 504 further comprises a plurality of compressed
holes 508. In this configuration, primary coupling member 516 is
stitched or woven through compressed holes 508, constricting
monosleeve 504 and expandable implant 502 to the diameter of the
collapsed configuration. The diameter of the collapsed
configuration is selected to allow for delivery of the expandable
implant 502 to the treatment area of the vasculature of a
patient.
[0060] Once expandable implant 502 has been delivered to a region
near the treatment area of the vasculature, primary coupling member
516 may be disengaged from monosleeve 504, allowing expandable
implant 502 to be expanded to the intermediate configuration.
Expandable implant 502 may be oriented and adjusted to a proper
location within the treatment area of the vasculature. After final
positioning, secondary coupling member 514 may be disengaged from
monosleeve 504, and expandable implant 502 may be expanded to the
expanded configuration.
[0061] Although a number of specific configurations of coupling
members (for example, primary and secondary coupling members) and
sleeves (for example primary and secondary sleeves) have been
discussed, the use of any number and/or configuration of
constraining members and sleeves is within the scope of the present
disclosure.
[0062] As discussed above, various embodiments may comprise a
plurality of expandable implants. In such embodiments, a single
sleeve, multiple sleeves, and/or multiple concentric sleeves may be
used in conjunction with the plurality of expandable implants. The
use of any number of expandable implants, with any configuration of
single or multiple sleeves, is within the scope of the present
disclosure.
[0063] In various embodiments, sleeves used to constrain expandable
implants may further comprise radiopaque markers. In such
configurations, radiopaque markers may be located at the edges of
sleeves, in the region where a coupling member is stitched through
the series of openings. Radiopaque markers may assist in the
positioning and orientation of the expandable implant within a
vasculature, for example, by increasing the visibility of the
location and orientation of sleeves and coupling member during the
use of a radiographic device, such as an x-ray.
[0064] For example, with reference to FIG. 1, sleeve 104c may
comprise a radiopaque marker (not shown). In various embodiments,
the radiopaque marker comprises a circumferential band, located at
or near the distal end of sleeve 104c. Any placement or
configuration of a radiopaque marker which assists in the location
and orientation of an expandable implant within a vasculature is
within the scope of the present disclosure.
[0065] In various embodiments of the present disclosure, an
expandable implant may comprise at least one target portion. In
such configurations, the target portion or portions are located on
the surface of the expandable implant. As noted above, in various
embodiments, the target portion or portions may comprise side
branch fenestrations. Side branch fenestrations allow for branching
devices, such as branching stent grafts, to be connected to and in
with communication the expandable implant. In various
configurations, the diameter of the side branch fenestrations may
be approximately the same as the vessel to be repaired. In other
configurations, the diameter of the side branch fenestrations may
be larger than the diameter of the vessel to be repaired. In yet
other configurations, the diameter of the side branch fenestrations
may be less than the diameter of the vessel to be repaired.
[0066] The cross sections of side branch fenestrations may be, for
example circular, "D" shaped, oval, triangular, square, polygon
shaped or randomly shaped. Side branch fenestrations of any
cross-sectional shape are within the scope of the present
disclosure.
[0067] In various embodiments, target portions may comprise a
fenestratable portion. In such configurations, the target portions
are comprised of a frangible material which may be fenestrated by
an endolumenal tool after the expandable implant has been partially
or completely implanted in the vasculature of a patient. Once
fenestrated, the target portion may be used, for example, to
install branching stent grafts to the expandable implant.
[0068] In various embodiments of the present disclosure which
comprise target portions, the target portions may be oriented such
that they are covered by one or more sleeves. In such
configurations, the target portions may be exposed to the
vasculature upon expansion of the one or more sleeves.
[0069] For example, with reference to FIG. 4, expandable device 300
comprises target portions 400 and 402. Target portions 400 and 402
are configured such that they are covered by sleeves 304a and 304b
when the expandable implant 302 is in a collapsed configuration.
Once sleeves 304a and 304b are expanded, expandable implant 302
expands to a larger diameter, exposing target portions 400 and 402
between parallel edges of the sleeves.
[0070] In other configurations, target portions may be oriented
such that they are surrounded, but not covered, by multiple
sleeves. For example, with reference to FIG. 2, catheter assembly
100 comprises an expandable implant 102 with target portions 200
and 202. In this embodiment, target portions 200 and 202 are
positioned such that they are surrounded, and not covered, by
adjacent sleeves 104a, 104b and 104c.
[0071] In such configurations, sleeves 104 may comprise lateral
openings 116 and/or 118. In various embodiments, lateral openings
116 and/or 118 comprise apertures, notches or indentations at
either or both ends of sleeves 104. Such apertures, notches or
indentations may interact with each other to surround, but not
cover, target portions 200 and/or 202.
[0072] For example, target portion 200 may be positioned between
the distal end 106 of sleeve 104a and the proximal end 108 of
sleeve 104b. Distal end 106 of sleeve 104a and proximal end 108 of
sleeve 104b may each comprise lateral openings 116 and/or 118 which
allow target portion 200 to be exposed to the vasculature of the
patient upon expansion of sleeves 104a and 104b.
[0073] Further, target portion 202 may be positioned between the
distal end 106 of sleeve 104b and the proximal end 108 of sleeve
104c. Distal end 106 of sleeve 104b and proximal end 108 of sleeve
104c may each comprise circular notches which allow target portion
200 to be exposed to the vasculature of the patient upon expansion
of sleeves 104b and 104c.
[0074] Additionally, in various embodiments having multiple sleeves
for example, to provide for collapsed, intermediate and full
deployment, lateral openings may be present in each of the sleeves
and located so as to allow the exposure of target portions to the
vasculature at each stage of deployment. In various embodiments,
the lateral openings of the primary and secondary sleeves may be of
different sizes, for example, smaller on the secondary sleeve (or
sleeves) and larger on the primary sleeve (or sleeves) (or vice
versa).
[0075] In various embodiments, target portions may be positioned
under lateral openings cut in a single sleeve. In such embodiments,
the lateral openings are large enough that the single sleeve acts
as multiple sleeves like those described above with regard to FIG.
2. For example, with reference to FIGS. 7A and 7B, sleeves 704a
and/or 704b may comprise at least one window which is large enough
and oriented such that the lateral openings are oriented over at
least one target portion. Any configuration of sleeve which allows
access to target portions of an expandable implant is within the
scope of the present invention.
[0076] In various embodiments, expandable devices may comprise a
plurality of target portions such that at least one target portion
is located between adjacent sleeves and at least one target portion
is located between the parallel edges of an expanded sleeve or
sleeves. Any configuration of target portions, including those
located between adjacent sleeves and those located between parallel
edges of an expanded sleeve, are within the scope of the present
disclosure.
[0077] In various embodiments of the present disclosure, the target
portions may comprise radiopaque segments. In such configurations,
the target portions may be surrounded by radiopaque segments or
markers which assist in locating and orienting the target portions
and the expandable implant within the patient's vasculature. In
various embodiments, the target portions comprise both radiopaque
segments and either a side branch fenestration or a fenestratable
portion. In these configurations, radiopaque segments may, among
other things, assist in the delivery to and installation of side
branch stent grafts to the target portions.
[0078] In various embodiments, a target portion may comprise a drug
eluting element. In these configurations, a drug eluting element
comprises a segment which releases a therapeutic agent or drug once
the target portion has been exposed to the vasculature of a
patient. Examples of such therapeutic agents or drugs include
prochlorperazine edisylate, ferrous sulfate, aminocaproic acid,
mecaxylamine hydrochloride, procainamide hydrochloride, amphetamine
sulfate, methamphetamine hydrochloride, benzphetamine
hydrochloride, isoproteronol sulfate, phenmetrazine hydrochloride,
bethanechol chloride, methacholine chloride, pilocarpine
hydrochloride, atropine sulfate, scopolamine bromide, isopropamide
iodide, tridihexethyl chloride, phenformin hydrochloride,
methylphenidate hydrochloride, theophylline cholinate, cephalexin
hydrochloride, diphenidol, meclizine hydrochloride,
prochlorperazine maleate, phenoxybenzamine, thiethylperazine
maleate, anisindione, diphenadione, erythrityl tetranitrate,
digoxin, isoflurophate, acetazolamide, methazolamide,
bendroflumethiazide, chlorpropamide, tolazamide, chlormadinone
acetate, phenaglycodol, allopurinol, aluminum aspirin,
methotrexate, acetyl sulfisoxazole, hydrocortisone,
hydrocorticosterone acetate, cortisone acetate, dexamethasone and
its derivatives such as betamethasone, triamcinolone,
methyltestosterone, 17-.beta.-estradiol, ethinyl estradiol, ethinyl
estradiol 3-methyl ether, prednisolone,
17-.beta.-hydroxyprogesterone acetate, 19-nor-progesterone,
norgestrel, norethindrone, norethisterone, norethiederone,
progesterone, norgesterone, norethynodrel, indomethacin, naproxen,
fenoprofen, sulindac, indoprofen, nitroglycerin, isosorbide
dinitrate, propranolol, timolol, atenolol, alprenolol, cimetidine,
clonidine, imipramine, levodopa, chlorpromazine, methyldopa,
dihydroxyphenylalanine, theophylline, calcium gluconate,
ketoprofen, ibuprofen, atorvastatin, simvastatin, pravastatin,
fluvastatin, lovastatin, cephalexin, erythromycin, haloperidol,
zomepirac, ferrous lactate, vincamine, phenoxybenzamine, diltiazem,
milrinone, captropril, mandol, quanbenz, hydrochlorothiazide,
ranitidine, flurbiprofen, fenbufen, fluprofen, tolmetin,
alclofenac, mefenamic, flufenamic, difuninal, nimodipine,
nitrendipine, nisoldipine, nicardipine, felodipine, lidoflazine,
tiapamil, gallopamil, amlodipine, mioflazine, lisinopril,
enalapril, captopril, ramipril, enalaprilat, famotidine,
nizatidine, sucralfate, etintidine, tetratolol, minoxidil,
chlordiazepoxide, diazepam, amitriptylin, and imipramine. Further
examples are proteins and peptides which include, but are not
limited to, insulin, colchicine, glucagon, thyroid stimulating
hormone, parathyroid and pituitary hormones, calcitonin, renin,
prolactin, corticotrophin, thyrotropic hormone, follicle
stimulating hormone, chorionic gonadotropin, gonadotropin releasing
hormone, bovine somatotropin, porcine somatropin, oxytocin,
vasopressin, prolactin, somatostatin, lypressin, pancreozymin,
luteinizing hormone, LHRH, interferons, interleukins, growth
hormones such as human growth hormone, bovine growth hormone and
porcine growth hormone, fertility inhibitors such as the
prostaglandins, fertility promoters, growth factors, and human
pancreas hormone releasing factor.
[0079] In various embodiments, target portions may comprise a
sensor such as a temperature and/or pressure sensor. In other
embodiments, the sensor may measure the rate of blood flow. Any
sensor which may be implanted or connected to target portions of an
expandable implant are within the scope of the invention and
irrespective of the type of sensor used, sleeves may be oriented
and configured such that the sensor or sensors are exposed the
vasculature of the patient upon expansion and/or removal of the
sleeves by structures and methods such as those disclosed
herein.
[0080] It will be apparent to those skilled in the art that various
modifications and variations can be made in the present disclosure
without departing from the spirit or scope of the disclosure. Thus,
it is intended that the present disclosure cover the modifications
and variations of this disclosure provided they come within the
scope of the appended claims and their equivalents.
[0081] Likewise, numerous characteristics and advantages have been
set forth in the preceding description, including various
alternatives together with details of the structure and function of
the devices and/or methods. The disclosure is intended as
illustrative only and as such is not intended to be exhaustive. It
will be evident to those skilled in the art that various
modifications may be made, especially in matters of structure,
materials, elements, components, shape, size and arrangement of
parts including combinations within the principles of the
disclosure, to the full extent indicated by the broad, general
meaning of the terms in which the appended claims are expressed. To
the extent that these various modifications do not depart from the
spirit and scope of the appended claims, they are intended to be
encompassed therein.
* * * * *