U.S. patent application number 11/246592 was filed with the patent office on 2007-04-12 for conduit for interventional procedures.
Invention is credited to Rochelle M. Hamer, Eric Gerard Johnson, Stanislaw L. Zukowski.
Application Number | 20070083215 11/246592 |
Document ID | / |
Family ID | 37890308 |
Filed Date | 2007-04-12 |
United States Patent
Application |
20070083215 |
Kind Code |
A1 |
Hamer; Rochelle M. ; et
al. |
April 12, 2007 |
Conduit for interventional procedures
Abstract
A conduit, such as an introducer sheath, catheter, or guide
catheter, incorporating two or more separate lumens to prevent the
entanglement of guidewires located at least partially within the
conduit. The lumens are separated by at least one disruptable
barrier that allows multiple lumens to be converted into fewer
lumens prior to or as a device is advanced through the introducer
sheath.
Inventors: |
Hamer; Rochelle M.;
(Flagstaff, AZ) ; Johnson; Eric Gerard;
(Flagstaff, AZ) ; Zukowski; Stanislaw L.;
(Flagstaff, AZ) |
Correspondence
Address: |
Kevin J. Boland;W. L. Gore & Associates, Inc.
551 Paper Mill Road
P.O. Box 9206
Newark
DE
19714-9206
US
|
Family ID: |
37890308 |
Appl. No.: |
11/246592 |
Filed: |
October 7, 2005 |
Current U.S.
Class: |
606/108 |
Current CPC
Class: |
A61F 2002/065 20130101;
A61F 2002/061 20130101; B29C 66/63 20130101; A61M 2025/0034
20130101; A61M 25/0662 20130101; A61M 25/0032 20130101; A61F
2250/0039 20130101; A61M 39/0693 20130101; A61F 2/954 20130101;
Y10T 156/10 20150115; B29C 66/51 20130101 |
Class at
Publication: |
606/108 |
International
Class: |
A61F 11/00 20060101
A61F011/00 |
Claims
1. A conduit for use in an interventional procedure comprising: a
main body having a length; at least one disruptable barrier within
the main body extending along at least a portion of the length of
the main body, defining at least two lumens within the main body;
wherein the barrier is adapted to be disrupted before or during the
procedure to reduce the number of lumens within the main body.
2. The conduit of claim 1, wherein the lumens are each adapted to
receive a separate elongated member and prevent the elongated
members from tangling with each other.
3. The conduit of claim 2, wherein at least one of the elongated
members is used to access side vessels.
4. The conduit of claim 1, that comprises at least two disruptable
barriers, defining at least three lumens within the main body.
5. The conduit of claim 1, that allows for delivery of a main
treatment device through the main body following disruption of the
barrier.
6. The conduit of claim 1, that includes at least one hemostatic
seal having multiple openings, each corresponding with each of the
lumens in the main body.
7. The conduit of claim 6, wherein the multiple openings are
adapted to form into a single opening.
8. The conduit of claim 1, wherein the barrier comprises a
membrane.
9. The conduit of claim 2, wherein the elongated member is a
guidewire.
10. The conduit of claim 1, wherein the disruptable barrier
material comprises a material selected from the group consisting of
polyethylene, polypropylene, polyvinyl chloride, polyurethanes,
siloxanes, polyetherester, polytetrafluoroethylene, polyimide,
nylon, polyethylene terephthalate, thermoplastic elastomers,
polyolefins, polyester, polyamides, polydimethylsiloxane, natural
rubber, polyether block amide, ethylene vinyl acetate, and
combinations thereof.
11. The conduit of claim 1, wherein the conduit is an introducer
sheath.
12. The conduit of claim 1, wherein the conduit is a guide
catheter.
13. The conduit of claim 1, wherein the at least one disruptable
barrier extends for substantially the entire length of the
conduit.
14. An introducer sheath having a length, a proximal end, and a
distal end comprising: A hemostatic seal located at the proximal
end; The hemostatic seal comprising at least one elastomeric
sealing disk; The at least one elastomeric sealing disk comprising
a plurality of interconnected guidewire insertion sites.
15. The introducer sheath of claim 14, wherein the hemostatic seal
comprises at least three elastomeric sealing disks.
16. The introducer sheath of claim 14, wherein the at least one
elastomeric sealing disk comprises at least three guidewire
insertion sites.
17. The introducer sheath of claim 15, wherein the at least one
elastomeric sealing disk comprises at least three guidewire
insertion sites.
18. The introducer sheath of claim 14, wherein the plurality of
guidewire insertion sites comprise pre-punctured holes sized to
accept a guidewire therethrough.
19. A kit comprising: An introducer sheath having a length, a
proximal end, a distal end, and a lumen extending from the proximal
end to the distal end; and A dilator having a length, a proximal
end, and a distal end, the dilator being sized to be locatable
within the lumen of the introducer sheath and having an outer
geometric shape that defines at least two lumens between the
introducer sheath and the dilator when the dilator is inserted into
the introducer sheath lumen.
20. The kit of claim 19, wherein the dilator outer geometric shape
comprises at least two longitudinally extending grooves sized to
accept a guidewire.
21. The kit of claim 19, wherein the dilator outer geometric shape
is cross-shaped, the cross-shape forming four lumens between the
dilator and the introducer sheath when the dilator is inserted into
the introducer sheath lumen.
22. The introducer sheath of claim 14, wherein the guidewire
insertion sites are interconnected by at least one slit.
23. The conduit of claim 1, wherein the main body has a first outer
diameter, wherein the first outer diameter is expandable to a
relatively larger diameter upon insertion of at least one elongated
member into the main body.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] Novel conduits, such as guide catheters and catheter
introducer sheaths, for use in interventional procedures,
particularly introducer sheaths adapted for use with multiple
guidewires.
[0003] 2. Description of Related Art
[0004] It is often desirable to use multiple guidewires in various
endovascular procedures. For example when deploying stent graft
aneurismal repair devices within branched vasculature, a first
guidewire would be used to access the main artery while second
and/or third guidewires would access the side branched arteries.
Stent grafts with multiple guidewire ports would then be advanced
along the respective guidewires and deployed at the desired sites.
A common problem associated with the use of multiple guidewires is
the "crossing" or entanglement of the guidewires in the vasculature
proximal to the treatment site. Crossed and entangled guidewires
prohibit or severely restrict the ability to advance a device with
multiple guidewire ports to the treatment site. An introducer
catheter or sheath is often employed to protect the vasculature
from possible damage due to the advancement of the guidewires,
catheters and subsequent devices but such use does not eliminate
the occurrence of crossed guidewires. See for example U.S. Pat. No.
6,884,258 (to Vardi et al.) for a disclosure of problematic crossed
guidewires.
SUMMARY OF THE INVENTION
[0005] The invention comprises a conduit (such as an introducer
sheath or a guide catheter) for use in an interventional procedure
comprising: a main body having a length; at least one disruptable
barrier within the main body extending along at least a portion of
the length of the main body, defining at least two lumens within
the main body; and wherein the barrier is adapted to be disrupted
before or during the procedure to reduce the number of lumens
within the main body. In an aspect of the invention the at least
two lumens are adapted to receive separate elongated members (such
as guide wires) and prevent the elongated members from tangling
with each other.
[0006] An aspect of the invention comprises an introducer sheath
that incorporates at least two separate lumens to prevent the
entanglement of at least two guidewires. The lumens are separated
by disruptable barrier(s) that allows multiple lumens to be
converted into fewer lumens. The barrier(s) forms at least two
separate lumens along at least a portion of the length of the
sheath. Guidewires and guide catheters can be advanced through the
separate lumens to a desired treatment site. The separated lumens
prevent the guidewires from crossing and becoming entangled. In an
aspect of the invention, an endovascular device having multiple
guidewire lumens and ports can then be "back-loaded" onto the
proximal ends of the guidewires. As the multi-lumen device is
advanced through the introducer sheath, the distruptable barrier
tears or separates to form fewer lumens, thus allowing the
multi-lumen device to pass while maintaining guidewire separation.
An operational procedure using an introducer sheath of the present
invention allows the user to initially place all required
guidewires into the target sites. After all required guidwires are
in place, the interventional device or devices can then be advanced
along the guidewires.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is a schematic representation of the abdominal part
of the aorta and its principal branches showing an introducer
sheath and multiple guidewires of the current art.
[0008] FIG. 2A is a partial, mid-section perspective view of a
multi-lumen introducer sheath according to a preferred embodiment
of the present invention.
[0009] FIG. 2B is an end view of the introducer sheath of FIG. 2A.
Shown are two disruptable barriers that form three lumens within
the introducer sheath.
[0010] FIG. 3 is a partial perspective view of a distal portion of
an introducer sheath according to the present invention. Shown are
three guidewires positioned within the aorta and within the two
renal arteries.
[0011] FIG. 4 is a perspective view of an introducer sheath
according to the present invention. Shown are the proximal ends of
three guidewires projecting from the proximal hub assembly.
[0012] FIG. 5 is a partial cross-sectional schematic view of a
distal end of a stent delivery system that is compatible with an
introducer sheath of the present invention.
[0013] FIG. 6 shows a perspective view of an introducer sheath 44
of the present invention. Shown is the distal end of the stent
delivery system being advanced toward the proximal hub
assembly.
[0014] FIG. 7 is a partial cross-sectional view of an introducer
sheath with two disruptable barriers. The barriers are shown being
ripped, deformed or in other words "disrupted" to form a single
lumen within the introducer sheath.
[0015] FIG. 8 is a partial perspective view of an introducer sheath
that has been fully "converted" or "transformed" into a single
lumen catheter by the disruption of the two internal barriers.
[0016] FIG. 9 is a partial perspective view of a stent delivery
system along with an introducer sheath according to the present
invention. Shown is the introducer sheath being partially withdrawn
to fully expose the constrained self-expanding stent portion of the
delivery system.
[0017] FIG. 10 is a schematic representation of an aortic section
with a partial perspective view of a stent delivery system. Shown
is a first or "main body" stent after deployment.
[0018] FIG. 11 is a schematic representation of an aortic section
with a perspective view of a deployed main body stent. Shown are
two guidewires within the targeted renal arteries that pass through
two side ports within the wall of the deployed main body stent.
[0019] FIG. 12 is a schematic representation of an aortic section
with a perspective view of a deployed main body stent. Shown is a
first side-branch stent delivery system being advanced over the
first guidewire 34.
[0020] FIG. 13 is a schematic representation of an aortic section
with a perspective view of a deployed main body stent. Shown is a
first side branch stent that has been deployed into the right renal
artery.
[0021] FIG. 14A is a schematic representation of an aortic section
with a perspective view of a deployed main body stent. Shown is a
second side branch stent that has been deployed into the left renal
artery.
[0022] FIG. 14B is a schematic representation of an aortic section
with a perspective view of a deployed main body stent and two
attached side-branch stents. Also shown is a dashed profile of a
bifurcated intraluminal device engaged into the main body
stent.
[0023] FIGS. 15A through 15C are top plane views of three
hemostatic sealing disks that incorporate pre-punctured guidewire
insertion sites and pre-slit device insertion slots.
[0024] FIG. 16 is a side view of three sealing disks aligned and
stacked to form a hemostatic sealing disk assembly.
[0025] FIG. 17A is an end view of a multi-lumen catheter having
three lumens prior to expansion.
[0026] FIG. 17B is an end view of the catheter of 17A after
expansion. The three lumen catheter of 17A has been converted into
a single lumen catheter by the expansion.
[0027] FIGS. 18A through 18C depict catheters with interior
barriers that can be disrupted. Once disrupted the catheter is
converted into a catheter with a fewer number of lumens.
[0028] FIG. 19A is an end view of a catheter having two lumens that
will transform into a single lumen catheter when expanded.
[0029] FIG. 19B is an end view of a catheter having three lumens
that will transform into a single lumen catheter when expanded.
[0030] FIG. 20 is an end view of a catheter of the present
invention. Shown is an end view of a catheter having four
disruptable barriers that form three lumens. The three lumens can
be converted into a single lumen when expanded.
[0031] FIG. 21 is an end view of a catheter of the present
invention. Shown is a catheter having two disruptable barriers that
form three lumens. Each barrier can have a slit (or other
longitudinal opening) that can release the guidewires as a delivery
catheter is advanced distally through catheter.
[0032] FIG. 22 is an end cross-sectional view of an introducer
sheath surrounding a dilator that has two flat surfaces. The
clearance space between the introducer sheath and the dilator flat
surfaces form two guidewire lumens.
[0033] FIG. 23 is an end cross-sectional view of an introducer
sheath surrounding a dilator that has three guidewire grooves.
[0034] FIG. 24 is an end cross-sectional view of an introducer
sheath surrounding a dilator that has two guidewire grooves and a
central lumen.
[0035] FIG. 25 is an end cross-sectional view of an introducer
sheath surrounding a dilator that has a "cross-shaped" profile that
forms four lumens.
[0036] FIGS. 26 and 27 are cross-sectional end views of guidewire
positioning catheters surrounded by an introducer sheath. The
guidewire positioning catheter has three guidewire lumens each
having a longitudinal slit or opening. The slit or opening allows
the guidewires to be released as a subsequent delivery system is
advanced through the introducer sheath.
DETAILED DESCRIPTION OF THE INVENTION
[0037] A better understanding of the present invention may be had
with reference to the several figures.
[0038] Shown in FIG. 1 is a schematic representation of the
abdominal part of the aorta and its principal branches. The
abdominal aorta 20 is characterized by a right renal artery 22 and
left renal artery 24. The large terminal branches of the aorta are
the right and left common iliac arteries 26 and 28. Each common
iliac artery branches into internal 30 and external 32 iliac
arteries. An external iliac artery 32 becomes the femoral artery
below the inguinal ligament. Internal iliac artery 30 is also known
as the hypogastric artery. Additional vessels (e.g., second lumbar,
testicular, inferior mesenteric, middle sacral) have been omitted
for simplification. The infrarenal aorta is that portion of the
aorta disposed between the renal arteries and the common iliac
arteries. Throughout this application the term "distal" refers to
the direction that is furthest away from the clinician or access
site and the term "proximal" refers to the direction that is
closest to the clinician or access site.
[0039] A typical procedure entails gaining initial femoral artery
access percutaneously or with a surgical access. A floppy guidewire
is then inserted into the artery past the treatment site to ensure
access is maintained. An introducer sheath consisting of the outer
sheath and an inner dilator is placed over the guidewire and into
the vessel to the treatment site or as far as it will go. The
dilator serves to both stiffen the sheath for pushability and to
create a smooth transition between the relatively sharp end of the
sheath and the tissue. The floppy guidewire is switched out for the
appropriate stiff guidewire using the sheath to maintain arterial
access. The dilator is then removed and the treatment device is
then guided over the guidewire and deployed.
[0040] As shown in FIG. 1, first, second and third guidewires 34,
36, 38 have been positioned within the main aorta 20 and within the
two renal arteries 22, 24. The guidewires have been positioned with
the aid of a single lumen introducer sheath 40 according to the
current art. As depicted in the cut away portion of the introducer
sheath, the three guidewires 34, 36, 38 are "crossed" 42 and
entangled within the introducer sheath. The crossed and entangled
guidewires prohibit or severely restrict the ability to advance
devices, and particularly multi-lumen devices, to the treatment
site.
[0041] FIG. 2A is a partial, mid-section perspective view of a
multi-lumen introducer sheath according to an aspect of the present
invention. Shown is an introducer sheath portion 44 having two
distruptable barriers 46, 48 that can extend through a substantial
length (or the entire length) of the introducer sheath 44. The two
disruptable barriers 46, 48 form first, second and third lumens 50,
52, 54 that can extend through a substantial length (or the entire
length) of the introducer sheath 44. Typical hemostatic valves,
radiopaque markers and sheath distal tip details have been omitted
for clarity.
[0042] Shown in FIG. 2B is an end view of the introducer sheath 44
of FIG. 2A. Shown are the two disruptable barriers 46, 48 that form
three lumens 50, 52, 54 within the introducer sheath 44.
[0043] FIGS. 3 through 14 depict an operational procedure used to
repair an aortic aneurysm that includes the deployment of three
stent grafts. The first stent graft is deployed across the main
body of the aorta adjacent to the two renal arteries. The second
and third stent grafts are then guided through "side branch"
openings within the main stent graft and are then deployed within
the renal arteries.
[0044] FIG. 3 is a schematic representation of the abdominal part
of the aorta and its principal branches. Included is a partial
perspective view of a distal portion of an introducer sheath 44
according to an aspect of the present invention. Shown are three
guidewires 34, 36, 38 positioned within the aorta 20 and within the
two renal arteries 22, 24. The guidewires have been positioned with
the aid of a three lumen introducer sheath 44 according to an
aspect of the present invention. Each guidewire is contained within
a separate lumen within the introducer sheath. As depicted in the
cut away portion of the introducer sheath, the three guidewires 34,
36, 38 are separated 56 and prevented from being "crossed" as a
result of the three separate lumens.
[0045] FIG. 4 is a schematic representation of an aortic section
with a perspective view of an introducer sheath 44 according to the
present invention. Shown is an introducer sheath 44 with three
separate lumens 50, 52, 54. Three guidewires 34, 36, 38 are shown,
each guidewire being contained within one of the three separate
lumens. The three guidewires are positioned distally into the main
portion of the aorta and into two renal arteries. The proximal ends
of the three guidewires project from the proximal hub assembly 58.
The proximal hub assembly contains a hemostatic valve assembly that
minimizes or prevents back-bleeding while also allowing advancement
of guidewires and subsequent devices. Additional hubs and
connectors, for example flushing hubs, have been omitted for
clarity.
[0046] FIG. 5 is a partial cross-sectional schematic view of a
distal end of a stent delivery system 60 that is compatible with an
introducer sheath of the present invention. Shown is a catheter 71,
containing two guidewire tubes 67, 69 along with a central catheter
shaft 61. The guidewire tubes 67, 69 have guidewire lumens 62, 66.
The central catheter shaft 61 has a guidewire lumen 64. All four
components 61, 71, 67, 69 extend to the proximal hub (not
shown).
[0047] A self expanding main body stent or stent graft (for
simplicity, as used herein it should be understood that "stent"
shall mean both a stent or a stent graft) 63 is shown compressed
onto the central catheter shaft 61. The self expanding stent 63 is
constrained in the compressed state by a flexible sheath 65. The
sheath 65 can be activated by a pull line (not shown) releasing a
series of "slip-knots" that allow the sheath to split open and
release the self expanding stent. The two guidewire tubes 67, 69
are passed through two side-branch openings in the stent 63 and
also pass through two openings within the flexible sheath 65. The
openings in the flexible sheath can be configured, for example, as
slits propagating to the seam line of the flexible sheath.
[0048] The three guidewires 34, 36, 38 (from FIG. 4, emanating from
the proximal hub assembly 58) are shown being "back-loaded" into
the three guidewire lumens 62, 64, 66 within the stent delivery
system 60, in the direction depicted by the arrows 73.
[0049] FIG. 6 shows a perspective view of an introducer sheath 44
of the present invention. Two guidewires 34, 38 are shown
back-loaded into the stent delivery system tubes 67, 69. The third
guidewire 36 is shown back-loaded into the guidewire lumen within
the central catheter shaft 61. Shown is the distal end of the stent
delivery system 60 being advanced in the direction 68 toward the
proximal hub assembly 58.
[0050] Shown in FIG. 7 is a partial cross-sectional view of an
introducer sheath 44 according to the present invention. A distal
end of a stent delivery system 60 has been inserted through the
proximal hub assembly 58 (see FIG. 6) and is being advanced
distally in the direction depicted by arrow 68. In portion 72, the
three guidewires 34, 36 and 38 are separated by the disruptable
barriers 46 and 48. As the stent delivery system 60 is advanced,
the barriers 46 and 48 tear, rip, deform or in other words
"disrupt" 70, thereby forming a single lumen within the introducer
sheath portion 74.
[0051] The term "disruptable barrier" is defined as a member that
creates at least two lumens within a catheter shaft and is tailored
to allow conversion to a fewer number of lumens. For example a pair
of disruptable barriers can create three separate lumens that are
then transformed into less than three lumens. Similarly, flexible
partitions or walls within a catheter can initially form several
lumens (for example four) that are subsequently converted into less
than four lumens. A disruptable barrier (or barriers) therefore
provides a means to prevent entanglement of at least two
guidewires, while also allowing the subsequent advancement of a
medical device along the guidewires. In an aspect of the invention,
a disruptable barrier (or barriers) provides a means to isolate and
prevent entanglement of at least two guidewires, while also
allowing the subsequent advancement of a medical device along the
guidewires.
[0052] FIG. 8 is a schematic representation of an aortic section
with a partial perspective view of an introducer sheath 44
according to the present invention. Shown is the distal end of a
stent delivery system 60 projecting from the distal end of the
introducer sheath 44. The introducer sheath 44 has been fully
"converted" or "transformed" into a single lumen catheter by the
disruption of the two internal barriers (46, 48 FIG. 2A). Also
shown are three guidewires 34, 36 and 38 located within the aorta
and within two renal arteries. The three guidewires are contained
within the stent delivery system guidewire lumens (62, 64 and 66 of
FIG. 5).
[0053] FIG. 9 is a schematic representation of an aortic section
with a partial perspective view of a stent delivery system 60 along
with an introducer sheath 44 according to the present invention.
Shown is the introducer sheath 44 being partially withdrawn from
the distal end of the stent delivery system 60, in the direction
depicted by arrow 76. The sheath 44 is partially withdrawn to fully
expose the constrained self-expanding stent portion of the delivery
system 60.
[0054] FIG. 10 is a schematic representation of an aortic section
with a partial perspective view of a stent delivery system. Shown
is a first or "main body" stent 78 after deployment. In a preferred
embodiment the main body stent is self-expanding and has
appropriate side hole openings 80 and 82 that roughly align to the
side branch arteries to be subsequently stented. The main body
stent 78 is compacted into the stent delivery system 60 (FIG. 9)
with the two guidewire tubes 67, 69 and two side branch guidewires
34, 38 pre-routed through the appropriate side holes or ports in
the main body stent. Thus when deployed, the two side branch
guidewires 34, 38 remain within the target vessels and are
pre-routed through the side ports in the main body stent. The
flexible sheath (FIG. 5, item 65) has been omitted for clarity.
[0055] FIG. 11 is a schematic representation of an aortic section
with a perspective view of a deployed main body stent 78. Shown are
two guidewires 34, 38 within the targeted renal arteries that pass
through two side ports 80, 82 within the wall of the deployed main
body stent 78. Shown is the central shaft 61 of the stent delivery
system (60, FIG. 9) being withdrawn along with the two guidewire
tubes 67, 69 and the catheter shaft 71, in the direction depicted
by arrow 76. The three guidewires 34, 36, 38 remain in their target
vessels.
[0056] Shown in FIG. 12 is a schematic representation of an aortic
section with a perspective view of a deployed main body stent 78.
Shown is a first side-branch stent delivery system 86 being
advanced over the first guidewire 34, in the direction indicated by
arrow 68. The side-branch stent can be self expanding and
constrained by a sheath in a manner similar to that of the main
body stent of FIG. 5.
[0057] Shown in FIG. 13 is a schematic representation of an aortic
section with a perspective view of a deployed main body stent 78.
Shown is a first side branch stent 88 that has been deployed into
the right renal artery 22. The first side branch stent 88 has been
deployed through the first side branch port 80 creating a seal
between the main body stent 78 and the first side branch stent
88.
[0058] Shown in FIG. 14A is a schematic representation of an aortic
section with a perspective view of a deployed main body stent 78.
Shown is a second side branch stent 90 that has been deployed into
the left renal artery 24. The second side branch stent 90 has been
deployed through the second side branch port 82 creating a seal
between the main body stent 78 and the second side branch stent
90.
[0059] The existing guidewire placements can be subsequently used
for additional diagnostics or repairs (such as ballooning or stent
placement). Additional repair or diagnostic devices can include but
are not limited to bifurcated stent grafts, single lumen tube
grafts, combinations of modular graft components, radiographic
injection devices, embolic filters, occlusion, anchoring or seating
balloons, fixation or anchoring devices and endoscopes. In a
preferred example the two side-branch guidewires 34, 38 can be
withdrawn and an additional device (or devices) can be advanced
along the central guidewire 36. When at the desired location
subsequent devices can be released and engaged to the "docking"
portion 92 of the main body stent 78 forming a complete repair of
the aneurysmal site.
[0060] For example, shown in FIG. 14B is a schematic representation
of an aortic section with a perspective view of a deployed main
body stent 78 and two attached side-branch stents. Also shown is a
dashed profile of a bifurcated intraluminal device 94 engaged into
the docking portion 92 of the main body stent 78.
[0061] As shown in FIG. 14A, the stents 78, 88, 90 can be balloon
expandable, self expanding or both. Self expanding stents can be
further "seated" with a balloon if desired, using the appropriate
guidewire or guidewires. The side ports 80 and 82 in the main body
stent 78 can incorporate side branch stent sealing features such as
conical interfaces, support frames, compliant surfaces etc. that
enhance or maintain an effective seal between the stents. Side
branch stents 88 and 90 can similarly incorporate sealing
features.
[0062] Although depicted in a renal/aortic repair procedure, the
devices and methods of the present invention can be used in other
repair procedures involving branched vessels. Anchoring balloons
can also be incorporated into the various guidewires to help
maintain the guidewire positions during the repair procedure.
[0063] During the insertion of an introducer sheath of the present
invention a "split" dilator can be used in a normal fashion. Such a
split dilator has longitudinal slits or separate stiffening
portions that are tailored to slip into the individual lumens of
the introducer sheath of the present invention.
[0064] The disruption or tearing of the barrier or barriers of the
present invention can be initiated, for example, with the use of a
"slitting tool". Such a slitting tool can be partially inserted
into the introducer sheath of the present invention prior to the
back loading of the first stent device. The slitting tool can
initiate the disruption or separation of the barrier/s and can then
be removed prior to the device insertion. Similarly, the distal tip
of the first stent device can incorporate a barrier "disrupting"
feature such as a sharp or fluted surface. Also, the barrier can be
of a material that will tear as a relatively blunt distal tip of a
catheter is advanced.
[0065] When multiple guidewires are used with an introducer sheath,
an effective hemostatic seal within the proximal hub assembly (FIG.
6, item 58) is desirable to minimize back-bleeding. Elastomeric
sealing disks can be incorporated into a proximal hub assembly
(FIG. 6, item 58) that are configured to allow the insertion of
multiple guidewires followed by the insertion of a larger device or
delivery system. Shown in FIG. 15A through 15C are top plane views
of three sealing disks 100A, 100B, 100C that incorporate
pre-punctured guidewire insertion sites 102. The guidewire
insertion sites can be interconnected to allow for the formation of
one orifice for the subsequent advancement of a larger device or
delivery system. For example, shown are pre-punctured guidewire
insertion sites 102 interconnected by linear pre-slit device
insertion features 104, or interconnected by curved pre-slit device
insertion features 106. The seals can also incorporate "rip able"
sections that readily separate or tear as an alternative to
pre-slit insertion features. Multiple sealing disks can then be
aligned and stacked together within the hub assembly to form an
effective guidewire or device hemostatic seal. Shown in FIG. 16 is
a side view of three sealing disks 100A, 100B, 100C aligned and
stacked to form a sealing disk assembly 108.
[0066] Disruptable barriers of the present invention can have
various configurations. Shown for example in FIG. 17A is an end
view of a multi-lumen catheter 110A having first, second and third
lumens 112, 114, 116. The multi-lumen catheter 110A can be expanded
(for example by the insertion of a device delivery system) to form
a single lumen 118 within the catheter as shown in end view, FIG.
17B. Thus the barriers of FIG. 17A "disrupt" to form a catheter
with fewer lumens. Suitable materials for use as disruptable
barriers include, but are not limited to, polyethylene,
polypropylene, polyvinyl chloride, polyurethanes, siloxanes,
polyetherester, polytetrafluoroethylene, polyimide, nylon,
polyethylene terephthalate, thermoplastic elastomers, polyolefins,
polyester, polyamides, polydimethylsiloxane, natural rubber,
polyether block amide (PEBAX), ethylene vinyl acetate, and
combinations thereof.
[0067] Similarly, FIGS. 18A through 18C depict catheters with
interior barriers that can be disrupted to form fewer lumens. Shown
in FIG. 18A is an end view of a catheter 120A with two disruptable
barriers 122 that form first and second lumens 112, 114. Shown in
FIG. 18B is an end view of a catheter 120B with three disruptable
barriers 122 that form first, second and third lumens 112, 114,
116. Shown in FIG. 18C is an end view of a catheter 120C with four
disruptable barriers 122 that form first, second, third and fourth
lumens 112, 114, 116, 117. In these embodiments the barriers can be
disrupted by pushing a device (or devices) distally along guide
wire(s) previously located in the lumens. The barriers can be
disrupted by being pushed aside as the device is advanced along the
guide wire.
[0068] Other configurations of the present invention, similar to
that of FIG. 17A, are configured with disruptable barriers. Shown
for example in FIG. 19A is an end view of a catheter 124A having
two lumens 112, 114 that will transform into a single lumen
catheter when expanded. Shown in FIG. 19B is an end view of a
catheter 124B having three lumens 112, 114, 116 that will transform
into a single lumen catheter when expanded.
[0069] Shown in FIG. 20 is an end view of a further embodiment of
the present invention. Shown is an end view of a catheter 126
having four disruptable membranes 122 that form three lumens 112,
114, 116. The three lumens can be converted into a single lumen
when expanded. Or, as discussed above, the lumens can be converted
into a single lumen by being pushed aside by a suitable device (or
devices) as the device(s) is advanced along guidewire(s) previously
located in the lumens.
[0070] Shown in FIG. 21 is an end view of an alternate embodiment
of the present invention. Shown is an end view of a catheter 130
having two disruptable barriers 131 that form three lumens 112,
114, 116. Guidewires are advanced and retained in these flexible
cylindrical lumens internally tangent to the inner surface of the
catheter. Each barrier can have a slit (or other longitudinal
opening) that can release the guidewires as a delivery catheter is
advanced distally through catheter 130.
[0071] Various cross-sectional profiles according to the present
invention can be extruded, formed by wrapping or windings, or be
comprised of multiple sections laminated or bonded together. The
initial number of lumens can include but are not limited to two,
three, four, five, six, seven, eight, nine or ten or more lumens.
These multi-lumen catheters can be converted, according to the
present invention, into "fewer than the initial number of lumens"
which includes but is not limited to one, two, three, four, five,
six, seven, eight, nine or ten or more lumens.
[0072] A catheter or introducer sheath having two disruptable
barriers that are "rip able", "slit able" or tear able can be
fabricated by providing, for example, a three piece mandrel having
a general cross-section or end view according to FIG. 2B. A tubular
member that has relatively high longitudinal strength but with
relatively low radial strength can be placed around the center
section of the three piece mandrel, forming an assembly. The
assembly can then be wrapped with an adhesive coated film or
constrained by an adhesive coated tube. After adhesive curing, the
mandrel sections can be removed producing a catheter having the
general cross-sectional profile as shown in FIGS. 2A and 2B. The
outer wall of the catheter is therefore formed by the film wrap or
tubular constraint. The two disruptable, (e.g., "rip able", "slit
able", or tear able) barriers are formed from the tubular member.
The low radial strength of the tubular member allows for the
tubular member to be readily slit along its longitudinal axis.
Suitable materials for use as rip able, slit able, or tear able
barriers include, but are not limited to, polyethylene,
polypropylene, polyvinyl chloride, polyurethane, siloxanes,
polyetherester, polytetrafluoroethylene, polyimide, nylon,
polyethylene terephthalate, thermoplastic elastomers, polyolefins,
polyester, polyamides, polydimethylsiloxane, natural rubber,
polyether block amide (PEBAX), and ethylene vinyl acetate, and
combinations thereof.
[0073] As an alternative to the concept of "disruptable barriers"
modified "dilators" used in conjunction with introducer sheaths can
be used to minimize or prevent the occurrence of crossed or
entangled guidewires. The dilator has a length, a proximal end, and
a distal end, the dilator is sized to be locatable within the lumen
of an introducer sheath. The introducer sheath has a length, a
proximal end, a distal end, and a lumen extending from the proximal
end to the distal end. The dilator is further defined as having an
outer geometric shape that defines at least two lumens between the
introducer sheath and the dilator when the dilator is inserted into
the introducer sheath lumen. Moreover, the dilator can comprise at
least one lumen defined by an inner surface of the dilator.
[0074] For example, a dilator can have two opposing flat surfaces
extending along its length. When inserted into the mating
introducer sheath, the flat surfaces form two guidewire lumens
between the dilator and the inner wall of the introducer sheath.
When the guidewires are positioned into the desired target site the
dilator can be removed and a delivery system can then be
back-loaded onto the guidewires and advanced through the introducer
sheath. The proximal guidewire positions can be maintained by
suitable fixation at the hub assembly. Shown in FIG. 22 is an end
cross-sectional view of an introducer sheath 132 surrounding a
dilator 134 that has two flat surfaces 136. The clearance space
between the introducer sheath 132 and the dilator flat surfaces 136
form two guidewire lumens. Shown are two guidewires 138 positioned
within the clearance space between the introducer sheath 132 and
the dilator flat surfaces 136. Clearances between the introducer
sheath 132 and dilator 134 have been exaggerated for clarity.
[0075] Shown in FIG. 23 is an alternate dilator according to the
present invention. Shown is an end cross-sectional view of an
introducer sheath 132 surrounding a dilator 134 that has three
guidewire grooves 140. Similarly, shown in FIG. 24 is an end
cross-sectional view of an introducer sheath 132 surrounding a
dilator 134 that has two guidewire grooves 140 and a central lumen
142, formed by the inner surface of the dilator.
[0076] Shown in FIG. 25 is an alternate dilator according to the
present invention. Shown is an end cross-sectional view of an
introducer sheath 132 surrounding a dilator 134 that has a
"cross-shaped" profile 144 that forms four lumens.
[0077] The modified dilators of the present invention therefore
provide a "means to isolate and prevent entanglement of at least
two guidewires" while also allowing the subsequent advancement of a
medical device along the guidewires.
[0078] The specific configurations used to form separate guidewire
lumens in the examples above can be embodied along the entire
length of the dilator. Alternatively, the guidewire lumen features
can be eliminated at the distal and/or proximal ends of the
dilator. The elimination of the guidewire features for example at
the distal end of the dilator allows a normal tapered tip of a
dilator to extend from the introducer sheath during insertion. The
dilator can then be further advanced into the introducer sheath to
expose the distal guidewire lumens. The specific lumens of the
present invention can be dimensioned to accept a variety of
guidewire sizes or other devices. In any event, once the guidewires
are advanced through the lumens and located at the desired
treatment sites, the dilator can be removed from the introducer
sheath lumen to allow for the advancement of the desired device(s)
over the guidewires. The concepts of disruptable barriers can be
combined with dilators modified to incorporate guidewire lumens. In
addition the distal end of an introducer sheath can have staggered
and/or angulated exit ports for the guidewires or other
devices.
[0079] Shown in FIGS. 26 and 27 are cross-sectional end views of
guidewire positioning catheters 146A-B surrounded by an introducer
sheath 132. As shown in FIGS. 26 and 27, the guidewire positioning
catheter 146A-B has three guidewire lumens 112, 114, 116 each
having a longitudinal slit or opening. The slit or opening allows
the guidewires to be released as a subsequent delivery system is
advanced through the introducer sheath.
[0080] The guidewire positioning catheters of the present invention
therefore provide a means to isolate and prevent entanglement of at
least two guidewires while also allowing the subsequent advancement
of a medical device along the guidewires.
[0081] A method of the present invention can include the following
steps: [0082] A) provide an introducer sheath and a matching
dilator system that provides a means to prevent entanglement of at
least two guidewires; [0083] B) insert and locate the introducer
sheath approximate to a desired target site; [0084] C) insert and
locate at least two guidewires within the introducer sheath; [0085]
D) back-load a medical device onto the at least two guidewires; and
[0086] E) advance the medical device over the at least two
guidewires through the introducer sheath to the desired target
site.
[0087] The means to prevent entanglement of at least two guidewires
can include the incorporation of at least one disruptable barrier
within the introducer sheath. Additional means to prevent
entanglement of at least two guidewires can include, but are not
limited to, the incorporation of at least two guidewire lumens into
the dilator or by the use of a guidewire positioning catheter.
[0088] While particular embodiments of the present invention have
been illustrated and described above, the present invention should
not be limited to such particular 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.
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