U.S. patent application number 12/620634 was filed with the patent office on 2010-03-18 for branched stent delivery system.
Invention is credited to Stanislaw Zukowski.
Application Number | 20100069853 12/620634 |
Document ID | / |
Family ID | 38616001 |
Filed Date | 2010-03-18 |
United States Patent
Application |
20100069853 |
Kind Code |
A1 |
Zukowski; Stanislaw |
March 18, 2010 |
Branched Stent Delivery System
Abstract
An interventional delivery system with a first catheter having
at its distal end a side branch vessel segment; a second catheter
attached around the first catheter and having at its distal end a
main vessel segment; a side branch vessel device attached to side
branch vessel segment of the first catheter; and main vessel device
attached to the main vessel segment of the second catheter. The
main vessel device and the side branch vessel device are able to be
simultaneously delivered to a treatment site.
Inventors: |
Zukowski; Stanislaw;
(Flagstaff, AZ) |
Correspondence
Address: |
Bridget Sciamanna;W. L. Gore & Associates, Inc.
551 Paper Mill Road
Newark
DE
19714-9206
US
|
Family ID: |
38616001 |
Appl. No.: |
12/620634 |
Filed: |
November 18, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11474165 |
Jun 23, 2006 |
|
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12620634 |
|
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Current U.S.
Class: |
604/264 ;
606/108 |
Current CPC
Class: |
A61F 2/954 20130101;
A61F 2002/821 20130101; A61F 2002/9511 20130101; A61F 2002/065
20130101; A61F 2/856 20130101; A61F 2002/061 20130101; A61F 2/07
20130101 |
Class at
Publication: |
604/264 ;
606/108 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61F 11/00 20060101 A61F011/00 |
Claims
1-23. (canceled)
24. A first catheter assembly comprising: a catheter having a shaft
and a reverse facing segment; a connection means to join said shaft
and reverse facing segment; and a side branch device positioned
onto the reverse facing segment.
25. A first catheter assembly comprising: a catheter having a shaft
and a reverse facing segment; a side branch device positioned onto
the reverse facing segment; a connection means to join said shaft
and reverse facing segment; and an apex formed by the open end of
the shaft and open end of the reverse facing segment to allow a
bifurcated guidewire to move freely within the catheter.
26. The first catheter assembly of claim 24 wherein the shaft and
the reverse segment are comprised of different materials.
27. The first catheter assembly of claim 24 wherein the shaft and
the reverse facing segment each have one or more openings near the
connection means.
28. The first catheter assembly of claim 24, wherein the shaft has
a first opening and a second opening and the reverse facing segment
has a first opening and second opening near the connection
means.
29. The first catheter assembly of claim 28 wherein the first
opening in the shaft and the first opening in the reverse facing
segment allow a bifurcated guidewire to move freely within the
catheter.
30. The first catheter assembly of claim 25 further comprising a
deployment line positioned in the shaft.
31. The first catheter assembly of claim 30 wherein the deployment
line is attached or integral to a constraining sheath.
32. The first catheter assembly of claim 31 wherein the deployment
line exits the reverse facing segment and enters the shaft.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of co-pending and
commonly owned U.S. Ser. No. 11/474,165, filed on Jun. 23,
2006.
BACKGROUND OF THE INVENTION
[0002] The present invention generally relates to a delivery system
and method for delivering an expandable endoluminal prosthetic
device such as a stent graft and more particularly to a device and
method for placing an acutely angled bifurcated stent graft through
a single access incision. Expandable surgical devices such as
stents or stent grafts are used in a variety of places in the human
body to repair aneurysms and to support various anatomical lumens,
such as blood vessels, respiratory ducts, gastrointestinal ducts,
and the like.
[0003] Conventionally, these devices are deployed across an
aneurysm or in the regions of a stenosis in the target body lumen
to repair the aneurysm or to hold the lumen open. Because stent
graft implantation is a relatively non-invasive procedure, it has
been proven to be a favorable alternative to surgery in, for
example, the repair of an aneurysm. Bifurcated devices with their
trunk and branching configuration are particularly well suited for
use in branching body lumen systems, such as in the coronary
vasculature, and the peripheral vasculature. The coronary
vasculature includes the right, left common, left anterior
descending and circumflex arteries and their branches. The
peripheral vasculature includes branches of the carotids, aorta,
femoral, popliteal, internal iliac, or hypergastric and related
arteries. Placement of such a bifurcated device can be rather
complicated, and often involves approaching the bifurcated section
of the artery through at least two side branches or through the
trunk plus one side branch. The procedure is not only time
consuming, but can also lead to more incision sites in the
patient's body and can necessitate more complicated maneuvers for
the surgeon. These complications are further exaggerated when an
acutely angled or reverse direction side branch is accessed, as for
example a repair of the hyporgastric artery. U.S. Pat. No.
6,645,242 teaches a bifurcated intravascular stent graft comprising
primary stent segments and a primary graft sleeve forming a main
fluid channel and having a side opening therethrough.
[0004] However, there exists a need for a stent graft delivery
system which would allow placement of bifurcated stent grafts into
acutely angled vasculature such that simpler surgical procedures
are enabled. A simplified surgical procedure would decrease the
number or size of incisions, reduce the required surgical steps,
and thereby reduce patient trauma associated with a more complex
medical procedure.
SUMMARY OF THE INVENTION
[0005] The present invention further provides an interventional
delivery system comprising: a first catheter having at its distal
end a side branch vessel segment; a second catheter attached around
the first catheter and having at its distal end a main vessel
segment; and a side branch vessel device attached to the side
branch vessel segment of the first catheter wherein the main vessel
segment and the side branch vessel device are simultaneously
delivered to a treatment site, and further wherein the second
catheter has an opening in a side wall near the distal end of the
second catheter to allow for passage of the side branch vessel
segment of the first catheter. The second catheter may comprise a
capture tube which surrounds the bifurcated guidewire and
facilitates for the ease of bifurcated guidewire removal from a
vessel. A bifurcated guidewire with at least two distal tips may be
used with the first catheter. The two distal tips face opposing
directions, wherein one of the two distal tips is the leading end
and one of the tips is a reverse facing tip end.
[0006] The present invention further provides a first catheter
having at its distal end a side branch vessel segment; a second
catheter attached around the first catheter and having at its
distal end a main vessel segment; a side branch vessel device
attached to the side branch vessel segment of the first catheter;
and a main vessel device attached to the main vessel segment of the
second catheter. The main vessel device and the side branch vessel
device are simultaneously delivered to a treatment site.
[0007] A method of deploying a branched stent assembly is also
provided comprising: advancing a catheter assembly on a bifurcated
guidewire to a treatment site; orienting the catheter assembly in
the main vessel; pulling the bifurcated guidewire to orient the
guidewire reverse facing tip into the side branch vessel; deploying
the main vessel device in the main vessel; then advancing the side
branch vessel device to a desired location; and deploying the side
branch device. After stent deployment, removal of the delivery
assembly is facilitated by advancing the guidewire and first
catheter forward until the guidewire reverse facing tip and reverse
facing portion of the first catheter are retracted from the side
branch vessel allowing removal of the bifurcated guidewire along
with the first and second catheters.
DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 shows the interventional delivery system comprising a
first catheter and a second catheter upon insertion in a
vessel.
[0009] FIGS. 2A and 2B show the first catheter of the
interventional delivery system. FIG. 2A depicts a bent shaft
configuration and FIG. 2B depicts a shaft configuration using a
connector.
[0010] FIG. 3 shows the bifurcated guidewire assembly with a
leading segment and a reverse facing segment.
[0011] FIG. 4A shows a first catheter with a bent shaft and apex
opening for the bifurcated guidewire with a side branch device
mounted on the side branch vessel segment of the first catheter
shaft.
[0012] FIG. 4B shows a first catheter with a shaft configuration
using a connector for the bifurcated guidewire with a side branch
device mounted on the side branch vessel segment of the first
catheter shaft.
[0013] FIG. 5 shows an enlarged view of the side branch vessel
segment with a side branch vessel device mounted and constrained
within a sheath.
[0014] FIGS. 6A and 6B show side views of a second catheter with a
side branch opening.
[0015] FIG. 7 is an isometric view of an expanded main body stent
graft.
[0016] FIG. 8 is a partial cross-sectional view of a main body
stent with a bifurcated guidewire and a first catheter with a side
branch device.
[0017] FIG. 9 is a partial cross-sectional view of a main body
stent with a bifurcated guidewire and a first catheter with a side
branch device contained in a second catheter. Also shown is a
constraint sheath over the main body stent and the apertures in the
main body stent and the constraining sheath.
[0018] FIGS. 10A and 10B show partial cross-sectional views of the
distal device portion and the proximal hub portions of the
interventional delivery system of the present invention. The distal
device portion is positioned within a main vessel adjacent to a
branched vessel.
[0019] FIGS. 11A and 11B show partial cross-sectional views of the
distal device portion and the proximal hub portions of the
interventional delivery system of the present invention. The
reverse facing guidewire is shown being advanced into the side
branch, acutely angled vessel.
[0020] FIGS. 12A and 12B show partial cross-sectional views of the
distal device portion and the proximal hub portions of the
interventional delivery system of the present invention. The main
body stent is shown in an expanded state.
[0021] FIGS. 13A and 13B show partial cross-sectional views of the
distal device portion and the proximal hub portions of the
interventional delivery system of the present invention. The
reverse facing segment of the first catheter with a constrained
side branch device is shown being advanced into the side branch,
acutely angled vessel.
[0022] FIGS. 14A and 14B show partial cross-sectional views of the
distal device portion and the proximal hub portions of the
interventional delivery system of the present invention. The side
branch stent is shown in an expanded state.
[0023] FIGS. 15A and 15B show partial cross-sectional views of the
distal device portion and the proximal hub portions of the
interventional delivery system of the present invention. The
reverse facing portion of the first catheter and the guidwire are
shown being advanced into a capture tube.
[0024] FIGS. 16A and 16B show partial cross-sectional views of the
distal device portion and the proximal hub portions of the
interventional delivery system of the present invention. The first
catheter, the second catheter, and the guidewire are shown being
withdrawn from the treatment site.
DETAILED DESCRIPTION OF THE INVENTION
[0025] The present invention provides an interventional delivery
system for the placement of bifurcated stent grafts into acutely
angled vasculature. Acutely angled vasculature may exist in renal
vessels, subclavian arteries, biliary ducts, prostate vessels, and
other non-vascular applications as well. The challenge in stent
placement is deployment from a main vessel such as a femoral artery
to a reverse acute angle vessel. The present invention provides a
device and procedure which decreases the number and size of
incisions required to place bifurcated stent grafts into acutely
angled vasculature, and further reduces the required surgical steps
and patient trauma associated with this traditionally more complex
medical procedure. As shown in FIG. 1, the present invention
provides an interventional delivery system 30 comprising a first
catheter shaft 32, a second catheter assembly 34A or 34B, a first
catheter hub assembly 36, a second catheter hub assembly 38, a
bifurcated guidewire leading tip 40, a bifurcated guidewire reverse
facing tip 42, a bifurcated guidewire proximal tip 44, and a device
assembly 46. The interventional delivery system 30 is shown
positioned in an anatomical main vessel 48 so that the device
assembly 46 is positioned approximate to an anatomical side branch
vessel 50. As described in subsequent figures, the device assembly
46 will be deployed to form a main body stent within the main
vessel 48 along with an integrated side branch stent within the
side branch vessel 50.
[0026] Shown in FIGS. 2 through 9 are various sub-components and
assemblies of the interventional delivery system 30 (of FIG. 1).
Shown in FIG. 2A is a first catheter assembly 52A having a first
catheter hub assembly 36. The hub assembly 36 includes a perfusion
port 54, a bifurcated guidewire port 56, a side branch deployment
line 58 protruding from a deployment line port 60. The first
catheter assembly 52A further comprises a first catheter shaft 32
that has an apex opening 62A. Apex opening 62A as shown is a
cut-opening through the wall of the first catheter shaft 32. The
first catheter shaft is shown bent about the apex opening 62A,
forming a reverse facing segment 64. The reverse facing segment 64
has a side branch device portion 66 and a side branch device to
apex opening separation length 68.
[0027] As shown in FIG. 2B a first catheter assembly 52B has a
first catheter hub assembly 36. The hub assembly 36 includes a
perfusion port 54, a bifurcated guidewire port 56, a side branch
deployment line 58 protruding from a deployment line port 60. The
first catheter assembly 52B further comprises a first catheter
shaft 32 that has an apex opening 62B. Apex opening 62B as shown
comprises the open ends of a cut catheter shaft 32. The two cut
ends are joined at connection 70. The two cut shafts as shown form
a reverse facing segment 64. The reverse facing segment 64 has a
side branch device portion 66 and a side branch device to apex
opening separation length 68.
[0028] Depicted in FIG. 3 is a bifurcated guidewire assembly 72
having a proximal tip and a main segment 76. Within the distal
portion of the guidewire main segment 76 is a connection 78,
defining a leading guidewire segment 80 and a reverse facing
guidewire segment 82. The leading guidewire segment has a leading
tip and the reverse facing guidewire segment has a reverse facing
tip.
[0029] FIG. 4A shows a first catheter assembly (52A of FIG. 2A)
combined with a bifurcated guidewire assembly (72 of FIG. 3).
Referring to FIGS. 2A, 3, and 4A, shown is a bifurcated guidewire
assembly 72 positioned within a first catheter assembly 52A. Shown
protruding from an apex opening 62A is the bifurcated guidewire
connection 78 along with the leading guidewire segment 80. The
proximal end of the bifurcated guidewire protrudes from the
bifurcated guidewire port 56 and the reverse facing tip of the
guidewire protrudes from the reverse facing segment of the first
catheter.
[0030] Similarly, FIG. 4B shows a preferred first catheter assembly
(52B of FIG. 2B) combined with a bifurcated guidewire assembly (72
of FIG. 3). Referring to FIGS. 2B, 3, and 4B, shown is a bifurcated
guidewire assembly 72 positioned within a first catheter assembly
52B. Shown protruding from an apex opening 62B is the bifurcated
guidewire connection 78 along with the leading guidewire segment
80. The proximal end of the bifurcated guidewire protrudes from the
bifurcated guidewire port 56, and the reverse facing tip of the
guidewire protrudes from the reverse facing segment of the first
catheter. The tube-to-tube connection 70 can include a
friction-reducing component or feature to allow the deployment line
58 to easily slide against the tubes or apex opening as the
deployment line is activated.
[0031] Shown in FIG. 5 are a partial cross-sectional view of the
reverse facing segment 64 that includes a side branch device
portion 66 and a side branch device to apex opening separation
length 68. Shown is the bifurcated guidewire 72 reverse facing tip
42 exiting from an olive 88. Positioned onto a side branch
accommodating segment 94 is a constrained, self-expanding side
branch device 90. The side branch device 90 is held in a compressed
state by a constraining sheath 92. Attached or integral to the
constraining sheath is a side branch device deployment line 58.
[0032] FIGS. 6A and 6B are side views of two embodiments of a
second catheter. Shown in FIG. 6A is a second catheter assembly 34A
having a second catheter hub assembly 38. The second catheter hub
assembly further includes a proximal perfusion port 54. The hub
assembly is joined to a second catheter main body 96. Near the
distal end of the second catheter main body 96 is a side branch
device opening 98, formed by a cut-out portion of the catheter
wall. The opening 98 allows a bifurcated guidewire and a side
branch device to be subsequently advanced from the second catheter.
After deployment, the bifurcated guidewire can be pulled through
the opening 98 into the second catheter for removal. At the distal
end of the second catheter main body is a capture tube portion 100.
This tube portion "captures" the bifurcated guidewire after device
deployment, allowing for a non-traumatic removal of the guidewire
and delivery system.
[0033] Similarly, FIG. 6B depicts an alternate embodiment of a
second catheter assembly 34B. The distal end of the second catheter
main body 96 is joined to the capture tube portion 100 by at least
one main body to capture tube joining member 102. The main body 96
and the capture tube 102 are therefore separated and connected by
the joining members 102. The gap between the main body and the
capture tube forms an opening 98 functionally similar to the
opening 98 shown in FIG. 6A.
[0034] FIG. 7 is an isometric view of an expanded main body device
104. An aperture 106 is formed in the main body device wall,
permitting a side branch device to be subsequently inserted through
and attached to the aperture/main body.
[0035] FIG. 8 is a partial cross-sectional view of a main body
device 104 surrounding a first catheter assembly 52B. A bifurcated
guidewire 72 is positioned within the first catheter (as previously
shown in FIG. 4B). A reverse facing portion of the first catheter
having a constrained side branch device is shown protruding through
an aperture 106 in the main body stent. Exiting from the reverse
facing portion of the first catheter is the reverse facing tip 42
of the bifurcated guidewire. Also shown are the first catheter
shaft 32 and the apex opening 62B.
[0036] FIG. 9 is a partial cross-sectional view of the components
depicted in previous FIG. 8 along with a second catheter 34B (refer
to FIG. 6B). Shown is a second catheter main body 96, connected to
a capture tube portion 100 by at least one joining member 102. The
distal end of the bifurcated guidewire is shown positioned within
the capture tube portion 100. The first catheter shaft 32 is shown
positioned within the second catheter main body 96. Also shown are
a constraining sheath 92 and the attached or integral main body
deployment line 109. The reverse facing portion of the first
catheter is shown protruding through an aperture 108 within the
constraining sheath 92.
[0037] A sequence used to deliver and deploy main body and side
branch stents according to the present invention is depicted in
FIGS. 10 through 16.
Deployment Step 1
[0038] FIG. 10A is a partial cross-sectional view of the distal end
of an interventional delivery system similar to that of FIG. 1. A
device assembly is shown initially positioned in an anatomical main
vessel 48 so that the device assembly is positioned approximate to
an anatomical side branch vessel 50. Shown are a bifurcated
guidewire leading tip 40 and a bifurcated guidewire reverse facing
tip 42. The device assembly (46 of FIG. 1) has been expanded to
display the internal components as shown in FIG. 9. FIG. 10B
depicts the proximal end of the interventional delivery system,
similar to that shown in FIG. 1. Shown are a first catheter hub
assembly 36 and a second catheter hub assembly 38.
Deployment Step 2
[0039] FIGS. 11A and 11B show the bifurcated guidewire reverse
facing tip 42 being advanced into the side branch vessel 50 along
the direction indicated by arrow 110. The guidewire reverse facing
tip 42 is advanced by pulling (in direction indicated by arrow 112)
on the proximal end of the guidewire. The two hub assemblies 36, 38
are held stationary as the proximal end of the guidewire is pulled.
As the proximal end of the guidewire is pulled, the guidewire
leading tip 40 is advanced towards the apex opening 62B in the
direction shown by arrow 114. The guidewire reverse facing tip 42
is therefore forced to advance into the side branch vessel 50 in
the direction of arrow 110.
Deployment Step 3
[0040] Referring to FIGS. 12A and 12B, the main body stent 104 is
deployed by pulling on the main body stent deployment line 109 in
the direction indicated by arrow 116. By releasing the constraining
sheath (92 of FIG. 9) the main body stent is allowed to self-expand
in the directions indicated by arrows 118. The two hub assemblies
36, 38 are held stationary as the deployment line is pulled. Note
that the guidewire and/or the side branch device are positioned
through the aperture 106 in the main body device 104.
Deployment Step 4
[0041] The side branch device is then advanced into the side branch
vessel, as depicted in FIGS. 13A and 13B. The side branch device is
advanced along the direction indicated by arrow 120 by holding
stationary the second catheter hub assembly 38 while concurrently
pulling on the guidewire proximal tip 44 and the first catheter hub
assembly 36. The guidewire may be optionally locked onto the first
catheter hub assembly 36 to facilitate this step. As the guidewire
and hub assembly are pulled, the distal tip of the guidewire 40 is
pulled in the direction indicated by arrow 124, forcing the side
branch device to advance partially through the main body device
aperture 106 and into the side branch vasculature 50 in the
direction 120.
Deployment Step 5
[0042] As shown in FIGS. 14A and 14B, the side branch deployment
line 58 is then pulled in the direction indicated by arrow 126,
allowing the side branch device 66 to self-expand as indicated by
arrows 128. Note that the side branch device is partially contained
within and constrained by the main body device aperture 106. The
two hub assemblies 36, 38 are held stationary as the deployment
line is pulled.
Deployment Step 6
[0043] Referring to FIGS. 15A and 15B, the delivery system of the
present invention is withdrawn from the vasculature by forcing the
reverse facing portion of the first catheter 64 out of the expanded
side branch device and into the capture tube 100 along the
direction as indicated by arrows 130. The first catheter reverse
facing portion is driven, into the capture tube by pushing the
first catheter hub assembly 36 along with the guidewire proximal
tip 44 along the direction as shown by arrows 132. The second
catheter hub assembly 38 is held stationary as the first catheter
hub assembly and the guidewire are advanced.
Deployment Step 7
[0044] To complete the delivery of the devices and systems of the
present invention, the first catheter hub assembly 36, the
guidewire proximal tip 44, and the second catheter hub assembly 38
are concurrently pulled in the direction as shown by arrows 134 of
FIGS. 16A and 16B. The capture tube 100, containing the bifurcated
guidewire and the reverse facing portion or the first catheter 64
are non-traumatically removed from the vasculature, leaving the
expanded main body device 104 and the attached side branch device
66 in the vasculature.
[0045] Referring back to FIG. 7, the main body device 104 is shown
with a single side-wall aperture 106. In an alternate
configuration, a main body device can have two, three, four, five,
six or more side branch apertures. The various catheters of the
present invention can incorporate more than one device; for
example, a first catheter can incorporate two or more side branch
devices. The sealing or interference fit between a main body and a
side branch device can be enhanced by the incorporation of a
"sealing sleeve". See for example U.S. Pat. No. 6,645,242 to Quinn
for a disclosure of such sealing sleeves. Multiple sealing sleeves
can be incorporated into a main body device to enhance the sealing
or attachment of multiple side branch devices. Sealing sleeves can
be "internal to" or "external to" the lumen of a main body stent
and can be shaped and sized to seal a specifically configured side
branch device.
[0046] Stents used in the present invention can be bare
(uncovered), coated with a variety of drug eluting,
anti-thrombogenic or other coatings, or can include a partial or
full cover (as in a stent graft). Anchoring mechanisms, such as
barbs, "fish-scales", biological attachment means, or other
features can be incorporated into the main body and/or a side
branch device to facilitate anchoring to the vasculature.
[0047] Main body stents and/or side branch stents can have a
uniform profile or have non-uniform profiles such as tapers,
"trumpet-end" shapes, "dog-bone" shapes, curves or other profiles
that enhance the device performance within a particular treatment
site. Multiple devices of the present invention can be "ganged" or
interconnected to form a multi-component system. Devices of the
present invention can include features that allow or enhance the
interconnection or "docking" between multiple devices.
[0048] Radiopaque markers or indicators can be incorporated into a
main body device, the various catheters used in the present
invention and/or a side branch device to facilitate placement and
visualization within the vasculature.
[0049] Devices of the present invention can be used to treat
non-vascular conduits, hollow or tubular parts of organs, such as
bilary, bladder, urethra, gastrological, bronchi, bile, and other
ducts. Devices of the present invention are particularly suited
for, but not limited to, side branch vessels that have an "acute"
angle from the main body (see for example FIG. 1).
[0050] Devices of the present invention can be balloon-expandable
as well as self-expanding. For example, the first catheter
according to the present invention can incorporate a balloon (or
balloons) and inflation lumens as required to expand a particular
device. Combinations of self-expanding and balloon-expandable
devices can be configured according to the present invention. Also,
separate balloon expanders can be used within the scope of the
present invention.
[0051] Catheter components of the present invention can be
fabricated from common materials such as nylons, polycarbonates,
polyethylenes, polypropylenes, polytetrafluoroethylenes, polyvinyl
chlorides, polyurethanes, polysiloxanes, stainless steels,
nitinols, or other biocompatible materials.
[0052] While particular embodiments of the present invention have
been illustrated and described herein, the present invention should
not be limited to such illustrations and descriptions. It should be
apparent that changes and modifications may be incorporated and
embodied as part of the present invention within the scope of the
following claims.
* * * * *