U.S. patent application number 13/629077 was filed with the patent office on 2013-01-24 for stent graft device.
This patent application is currently assigned to CORDIS CORPORATION. The applicant listed for this patent is DAVID C. MAJERCAK. Invention is credited to DAVID C. MAJERCAK.
Application Number | 20130023979 13/629077 |
Document ID | / |
Family ID | 38093593 |
Filed Date | 2013-01-24 |
United States Patent
Application |
20130023979 |
Kind Code |
A1 |
MAJERCAK; DAVID C. |
January 24, 2013 |
STENT GRAFT DEVICE
Abstract
A stent graft device for implanting in a body lumen, comprising
a stent with non-staggered or staggered apexes, said stent
comprising a plurality of stent sections, bendable connecting
members forming said non-staggered or staggered apexes and
connecting each of said stent sections to other stent sections to
form a zigzag pattern, wherein said stent is staggerdly sutured to
a graft by a plurality of suture knots, and wherein said suture
knots and staggered apexes are staggered when said stent sections
are crimped, and methods of use thereof.
Inventors: |
MAJERCAK; DAVID C.;
(Stewartsville, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MAJERCAK; DAVID C. |
Stewartsville |
NJ |
US |
|
|
Assignee: |
CORDIS CORPORATION
Bridgewater
NJ
|
Family ID: |
38093593 |
Appl. No.: |
13/629077 |
Filed: |
September 27, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11376641 |
Mar 15, 2006 |
|
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13629077 |
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Current U.S.
Class: |
623/1.11 ;
623/1.13 |
Current CPC
Class: |
A61F 2/915 20130101;
A61F 2002/075 20130101; A61F 2/07 20130101; A61F 2/88 20130101 |
Class at
Publication: |
623/1.11 ;
623/1.13 |
International
Class: |
A61F 2/06 20060101
A61F002/06; A61F 2/84 20060101 A61F002/84 |
Claims
1. (canceled)
2. (canceled)
3. (canceled)
4. (canceled)
5. (canceled)
6. (canceled)
7. (canceled)
8. (canceled)
9. (canceled)
10. (canceled)
11. (canceled)
12. (canceled)
13. (canceled)
14. (canceled)
15. (canceled)
16. (canceled)
17. A method for implanting a stent graft device comprising: a)
providing a delivery catheter; b) mounting said stent graft device
onto said catheter, said tubular stent having a first unexpanded
diameter when mounted on the delivery catheter, and a second
expanded diameter once deployed and defining a longitudinal
direction and a circumferential direction, the stent comprising a
plurality of individual stent segments each having a zigzag shaped
pattern formed into a tubular shape with a first open end and a
second open end, wherein the first open end has a row of first
apexes coming to a point and the second open end has a row of
second apexes coming to a point, the adjacent apexes in the row of
first apexes being staggered in the circumferential direction with
one another and the adjacent apexes in the row of second apexes
being staggered in the circumferential direction with one another;
and graft material affixed to the stent to create a fluid carrying
conduit, the graft material being affixed to the stent by a
plurality of sutures that are knotted, the suture knots being
stitched to the graft material sufficiently close to the apexes in
a staggered pattern relative to the circumferential direction such
that each suture knot has an associated apex by virtue of its
proximity to the sufficiently close apex, whereas the suture knots
associated with circumferentially adjacent apexes in the same row
of apexes are not circumferentially aligned, and wherein the
circumferentially adjacent suture knots associated with the apexes
in the same row do not touch one another when the stent segment is
at its first unexpanded diameter; c) delivering said stent graft
device percutaneously through the patient's vasculature to a
specific location in body lumen; d) deploying said stent graft
device into the body lumen; and e) withdrawing said catheter from
said patient leaving said stent graft device deployed in the body
lumen.
18. The method of implanting a stent graft device according to
claim 17, further comprising positioning said stent graft device at
an aneurysm in the vasculature, and affixing said stent graft
device to the lumen wall adjacent the aneurysm.
19. The method of implanting a stent graft device according to
claim 18, further comprising affixing said stent graft device in an
abdominal aorta proximal and distal to an abdominal aortic
aneurysm.
20. The method of implanting a stent graft device according to
claim 17 further comprising reducing the profile of said stent
graft by further crimping said stent graft device, causing said
apexes and said suture knots to become more staggered.
21. The stent graft device according to claim 17, wherein said
apexes are sufficiently close to said sutured knots to
substantially prevent micromotion of said apexes.
22. The stent graft device according to claim 17, wherein said
stent sections are comprised of stainless steel, tungsten,
platinum, gold, titanium, elgiloy, heat activatable NITINOL,
polymer materials, or combinations thereof.
23. The stent graft device according to claim 22, wherein said
stent sections are comprised of NITINOL.
24. The stent graft device according to claim 17, wherein said
stent sections are formed from a single piece of tubing.
25. The stent graft device according to claim 17, wherein said
stent sections are formed from a flat sheet of material.
Description
BACKGROUND OF THE INVENTION
[0001] The invention relates generally to endoprostheses and, more
specifically, to a stent graft device for delivery to an area of a
body lumen that has been weakened by damage or disease, such as an
aneurysm of the abdominal aorta. Several areas of the body are
particularly suitable for receiving an endoprosthesis, commonly
referred to as an intraluminal stent to hold open and insure the
patency of a body lumen. Two such areas include the coronary
arteries and the aorta, especially in the area where an aneurysm
has developed.
[0002] An abdominal aortic aneurysm ("AAA") is an abnormal dilation
of the arterial wall of the aorta in the region of the aorta that
passes through the abdominal cavity. The condition most commonly
results from atherosclerotic disease. Frequently, abdominal aortic
aneurysms are dissecting aneurysms, that is aneurysms that are
formed when there is a tear or fissure in the arterial lining or
wall through which blood is forced and eventually clots, forming a
thrombosis which swells and weakens the vessel. Abdominal aortic
aneurysms do not cause pain, but can be detected in a thorough
physical examination. If the aneurysm is not detected and treated,
it is likely to rupture and cause massive hemorrhaging fatal to the
patient.
[0003] AAAs have been traditionally treated by some form of
arterial reconstructive surgery which commonly is referred to as a
"triple-A" procedure. One such method is by-pass surgery, in which
an incision is made into the abdominal cavity, the aorta is closed
off above and below the site of the aneurysm, the aneurysm is
resected, and a synthetic graft or tube sized to approximate the
diameter of the normal aorta is sutured to the vessel to replace
the aneurysm and to allow blood flow through the aorta to be
reestablished. The graft commonly is fabricated of a biocompatible
material that is compliant and thin-walled. Nylons and synthetic
fibers such as those manufactured under the trademarks DACRON or
TEFLON have been found to be suitable for the construction of the
graft. Studies have shown that the mortality rate associated with
this surgical procedure is favorable (less than 5%) when it is
performed prior to rupture of an aneurysm. However, patients having
an AAA typically are over 65 years of age, and often have other
chronic illnesses which increase the risk of perioperative or
post-operative complications. Those patients thus are not ideal
candidates for this type of major surgery. Further, it has been
pointed out that this procedure is not often successfully resorted
to after an aneurysm has ruptured (the mortality rate increases to
over 65%) because of the extensiveness of the surgery and the time
required to prepare a patient for it.
[0004] Because of the aforementioned disadvantages to conventional
surgical methods, another procedure was developed as an alternative
to conventional, major surgery. This method also involves
emplacement of a graft at the site of the aneurysm; however, the
graft is deployed there by being routed through the vascular system
carried by a catheter, wire or other device suitable for
negotiating the vasculature.
[0005] More recently, grafts have been used in combination with
stents, wherein the apexes of the stents are aligned
circumferentially when the stent is crimped which may increase the
overall delivery profile. There is an ongoing need for lower
profile stents-grafts for treating AAA in order to better treat
patients less invasively.
SUMMARY OF THE INVENTION
[0006] One aspect of the invention relates to a stent graft device
for implanting in a body lumen, comprising a stent with
non-staggered apexes, said stent comprising a plurality of stent
sections, bendable connecting members forming said non-staggered
apexes and connecting each of said stent sections to other stent
sections to form a zigzag pattern, wherein said stent is staggerdly
sutured to a graft by a plurality of suture knots, and wherein said
suture knots are staggered when said stent sections are
crimped.
[0007] Another aspect of the invention relates to a stent graft
device for implanting in a body lumen, comprising a stent with
staggered apexes, said stent comprising a plurality of stent
sections, bendable connecting members forming said staggered apexes
and connecting each of said stent sections to other stent sections
to form a zigzag pattern, wherein said stent is staggerdly sutured
to a graft by a plurality of suture knots, and wherein said apexes
and said suture knots are staggered when said stent sections are
crimped.
[0008] In other embodiments, some of the staggered apexes of the
stent graft devices described above are projected and contact and
penetrate the body lumen.
[0009] Preferably, the stents have staggered apexes and the
staggered apexes are sufficiently close to the suture knots to
substantially prevent micromotion of the apexes.
[0010] In other embodiments, the stent sections are formed from a
single piece of tubing.
[0011] In other embodiments, the stent sections are formed from a
flat sheet of material.
[0012] Another aspect of the invention relates to a method for
implanting the stent graft devices described above comprising:
[0013] a) providing a delivery catheter; [0014] b) mounting the
stent graft device onto the catheter; [0015] c) delivering the
stent graft device percutaneously through the patient's vasculature
to a specific location; [0016] d) deploying the stent graft device
into the body lumen; and [0017] e) withdrawing the catheter from
the patient leaving the stent graft device deployed in the body
lumen.
[0018] The above method can employ the stent with staggered apexes
or non-staggered apexes in the stent graft device.
[0019] In another embodiment, the method of implanting the stent
graft device further comprises positioning the stent graft device
at the aneurysm, and affixing the stent graft device to the aortic
wall where the aneurysm is. In this embodiment, it is preferred
that the stent graft device is used for repairing abdominal aortic
aneurysm.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1. depicts a typical stent graft device using a stent
(1) with non-staggered apexes (3a), wherein the non-staggered
apexes (3a) and suture knots (4) are aligned to create a localized
profile increase.
[0021] FIG. 2. depicts a stent graft device of the present
invention using a stent (1) with non-staggered apexes (3a), wherein
the stent (1) is staggerdly sutured by a plurality of suture knots
(4) which are staggered when crimped to reduce the profile.
[0022] FIG. 3. depicts a stent graft device of the present
invention using a stent (1) with staggered apexes (3b), wherein the
stent (1) is staggerdly sutured by a plurality of suture knots (4)
which are staggered when crimped to reduce the profile.
[0023] Other features and advantages of the present invention will
become more apparent from the following detailed description of the
invention, and taken in conjunction with the accompanying exemplary
drawings.
DETAILED DESCRIPTION OF THE INVENTION
[0024] The invention relates to a stent graft device for implanting
in a body lumen. FIG. 2 shows a stent (1) with non-staggered apexes
(3a), wherein the stent (1) comprises a plurality of stent sections
(2), bendable connecting members forming the non-staggered apexes
(3a) and connecting each of the stent sections (2) to other stent
sections (2) to form a zigzag pattern, wherein the stent (1) is
staggerdly sutured to a graft by a plurality of suture knots (4),
and wherein the the suture knots (4) are staggered when the stent
sections (2) are crimped.
[0025] Another aspect of the invention relates to a stent graft
device for implanting in a body lumen, as depicted in FIG. 3,
comprising a stent (1) with staggered apexes (3b), wherein the
stent (1) comprises a plurality of stent sections (2), bendable
connecting members forming the staggered apexes (3b), and
connecting each of the stent sections (2) to other stent sections
(2) to form a zigzag pattern, wherein the stent (1) is staggerdly
sutured to a graft by a plurality of suture knots (4), and wherein
the staggered apexes (3b) and suture knots (4) are staggered when
the stent sections (2) are crimped.
[0026] It is contemplated in this invention that the stent graft
device can comprise one or more stents (1) sutured to a graft.
[0027] When the stent (1) used in the stent graft device has
non-staggered apexes (3b), the non-staggered apexes (3a) are not as
close to the sutured knots (4) as when the stent (1) which has
staggered apexes (3b). In a preferred embodiment, the stent (1) has
staggered apexes (3b) and the staggered apexes (3b) are
sufficiently close to the suture knots (4) to substantially prevent
micromotion of the staggered apexes (3b). Apexes and terminated
point-like knots create local bulk and when aligned
circumferentially create large and localized bulk, therefore,
staggering these areas reduce profile.
[0028] Grafting systems, which are systems that include a graft and
a stent, that are known in the art can be used in the present
invention, and these grafting systems are typically made of
biocompatible material and can include an attachment system for
anchoring the graft to a body lumen. The stent can be a tubular
device which is fitted inside and is generally coaxial with the
graft. The stent can also extend out of the graft. The attachment
system can have a lattice-like or open weave structure, which
provides it with flexibility and which promotes rapid endothelial
tissue growth through the structure once the graft has been
deployed. It can be provided with additional hook-like elements for
penetration of the intimal walls for attachment of the graft to the
aorta, or those hook-like elements can be provided on the graft
itself. Graft systems described in U.S. Pat. No. 4,787,899
(Lazarus); U.S. Pat. No. 5,104,399 (Lazarus); U.S. Pat. No.
5,219,355 (Parodi et al.); and U.S. Pat. No. 5,275,622 (Lazarus),
which are incorporated herein by reference, can be used in the
present invention. Furthermore, it should be understood to one
skilled in the art that any point-like attachment mechanisms such
as staples, clamps, etc., can be used.
[0029] The actual function of delivering the graft can be
accomplished by inflating a balloon of a catheter by introducing
pressurized fluid into a lumen of the catheter from a source
external to the patient. Inflation of the balloon applies a force
to the graft and any attachment system supplied therein which
extends radially and presses the graft and attachment system into
the vessel wall just above and just below the aneurysm.
[0030] In another embodiment, the stent-graft device can be
delivered intraluminally by being mounted on the balloon portion of
a delivery catheter and delivered intraluminally in a portion of a
body lumen. Once the stent graft device is positioned at the site
where it is to be implanted, the balloon portion of the catheter
can be expanded by known means to expand the stent outwardly into
contact with the body lumen. The balloon portion of a delivery
catheter can be substituted for by any expansion member capable of
receiving the stent graft device and expanding or urging the stent
graft device outwardly into contact with the body lumen. Other
non-limiting means that are available to urge outwardly and expand
the stent graft device include mechanical, hydraulic, pneumatic,
and phase transition using memory-shaped alloys or superelastic
alloys.
[0031] For example, the stent graft device can be mounted on a
balloon and delivered intraluminally by an over-the-wire catheter.
Guidewire can be used to navigate the patient's vasculature and
assist in positioning the catheter and balloon carrying the stent
graft device.
[0032] The graft and its deployment system can be introduced into
the blood stream percutaneously with a femoral approach and the
entire procedure can be performed using local or general
anesthesia.
[0033] Once the stent graft device has been positioned at the
aneurysm, it can be disengaged from the delivery system and can be
affixed to the aortic wall where the aneurysm is. For this purpose,
grafting systems can include fixation means such as staples or
hooks which can be manipulated and driven into the intima of the
vessel via some mechanical feature of the system, or by some
physical process, such as expansion of the graft through
application of pressure. To avoid premature detachment of the stent
graft device and to prevent the attachment elements from damaging
the vessels or halting the forward movement of the system while the
stent graft device is being routed to the treatment site, the
systems can be provided with a feature such as a capsule or a
sheath that protects and contains the stent graft device until such
time as deployment is desired.
[0034] Once the stent graft device is in place, it can be
positioned in the vessel spanning the site of the aneurysm such
that the walls of the stent graft device are generally parallel to
the walls of the affected area of the aorta. The aneurysm thus is
excluded from the circulatory system by the stent graft device. If
the aneurysm is a dissecting type and a thrombosis exists between
the walls of the aorta, the now-excluded aneurysm can beneficially
provide structural support for the stent graft device.
[0035] Other devices which can be used to attach the graft to the
aortic wall for AAA repair can include intravascular stents of the
type found in U.S. Pat. No. 5,316,023.
[0036] In another embodiment, the stent sections (2) which are used
in the stent graft device, for the treatment and repair of
aneurysms, is composed of a biocompatible material and is
simultaneously flexible enough to comply with the catheter or other
element used to route the stent graft device through the vascular
path to the site of the aneurysm and strong enough radially to
maintain the opening in the stent graft device once delivered. In
another embodiment, the stent graft device can affix itself to the
aortic walls. For instance, the stent (1) can have hooks or jagged
ends to enable the stent to affix itself to the aortic wall.
[0037] It is also contemplated that each of the embodiments can be
used in the stent graft device to repair other body lumens such as
the coronary arteries. Thus, for example, the stent graft device of
the present invention can be implanted in a coronary artery after a
PTCA procedure in order to repair a damaged or diseased portion of
the artery. The stent (1) will be deployed and implanted similar to
that described above, with the exception that stent graft device
may be correspondingly smaller in the coronary arteries than in the
aorta.
[0038] The stent graft device can be used in the invention and can
be made of any known tubular graft or bifurcated graft. Preferably,
the stent graft device is used for repairing an aortic aneurysm,
coronary arteries, and other vessels, however, other body lumens
are equally suited to receive the stent graft device of the present
invention.
[0039] In keeping with the invention, FIGS. 2 and 3 depicts stent
sections (2) which are connected by a plurality of bendable
connecting members forming non-staggered apexes (3a) as shown in
FIG. 2) and staggered apexes (3b) as shown in FIG. 3). The stent
sections (2) can be formed from a flat sheet of material.
Alternatively, the stent sections (2) can be formed from a piece of
tubing using known chemical etching or laser cutting
techniques.
[0040] It is advantageous for the stent graft device to have suture
knots (4) that are staggerdly stitched to the stent graft device to
lower the profile. In a particularly preferred embodiment, the
stent (1) in the stent graft device has staggered apexes (3b) and
the staggered apexes (3b) are sufficiently close to the suture
knots (4) to substantially prevent micromotion of the staggered
apexes (3b). The staggered apexes (3b) enables the stent graft
device to have a lower profile so that the contents of the stent
graft device are more evenly distributed throughout and are easier
to deliver.
[0041] It is preferred to position the stent graft device so that
it spans the aneurysm and diverts blood flow from the aorta through
the stent graft device, so that no blood flow leaks around the
stent graft device and into the aneurysm. Preferably the cranial
end of the stent graft device is positioned in the aortic wall
where there is healthy tissue, and not where the aneurysm has
weakened the vessel wall.
[0042] Although a particular form of catheter has been described to
route the stent graft device to the aneurysm, it will be apparent
to those skilled in the art in treating aneurysms and similar
conditions, that catheters having various configurations could be
used successfully to perform the same functions. For example,
well-known fixed wire and rapid exchange wire systems also can be
used in the delivery system described above.
[0043] The stent sections (2) can be made of stainless steel by
itself, or in combination with other materials. Other materials, in
addition to stainless steel, for the stent sections (2) are
contemplated, which include tungsten, platinum, gold, titanium,
elgiloy, heat activatable metal such as NITINOL, polymer materials,
or combinations thereof. The thickness of the metal can be in the
range of about 0.25 to about 0.50 millimeters in thickness.
Preferably, the stent sections (2) are made of NITINOL.
[0044] The stent sections (2) can be formed, for example, from a
flat sheet of material or from a single sheet of stainless steel
tubing by chemically etching, laser cutting, or by using electronic
discharge machining. For example, the stent sections (2) can be
made according to the description of U.S. Pat. No. 5,780,807, which
is incorporated herein by reference.
[0045] It is also contemplated that the bendable connecting members
forming the staggered apexes (3b) or non-staggered apexes (3a)
include an area along the connecting member made of a material that
is thinner or necked-down relative to the rest of the connecting
member. The bendable connecting member can also be formed by a
metal different from the metal forming the rest of the stent (1) or
by selectively treating an area of the native material. For
example, the stent sections (2) can be formed from stainless steel,
while the bendable connecting member can be formed from any
material having a lower modulus of elasticity which will bend more
easily than the stainless steel.
[0046] While the invention has been illustrated and described
herein in terms of its use as a stent-graft device for use in the
aorta to repair an aortic aneurysm, it will be apparent to those
skilled in the art that the stent graft device can be used in other
instances in other vessels of the body.
[0047] Other modifications and improvements can be made without
departing from the scope of the invention. For example, the various
drawing figures depict several configurations of the stent (1) and
various sizes, each of which can be modified to suit a particular
application without departing from the spirit and scope of the
invention.
* * * * *