U.S. patent application number 11/073421 was filed with the patent office on 2005-09-08 for sheath for use in peripheral interventions.
This patent application is currently assigned to FlowMedica, Inc.. Invention is credited to Ball, Craig A., Elkins, Jeffrey M., Goodson, Harry B. IV.
Application Number | 20050197624 11/073421 |
Document ID | / |
Family ID | 35056678 |
Filed Date | 2005-09-08 |
United States Patent
Application |
20050197624 |
Kind Code |
A1 |
Goodson, Harry B. IV ; et
al. |
September 8, 2005 |
Sheath for use in peripheral interventions
Abstract
A dual lumen introducer sheath provides access to at least one
renal artery and at least one peripheral blood vessel of a patient.
The introducer sheath includes a proximal hub comprising first and
second ports, a first lumen, and a second lumen. The first lumen
extends from the first port to a first distal aperture and has
sufficient length such that when the first port is positioned
outside the patient the first distal aperture is positionable in
the abdominal aorta at or near origins of the patient's renal
arteries. The second lumen extends from the second port to a second
distal aperture, has a shorter length than the length of the first
lumen, and is configured to allow passage of a catheter device
through the second lumen and into or through an iliac artery
contralateral to an insertion point of the introducer sheath into
the patient.
Inventors: |
Goodson, Harry B. IV;
(Fremont, CA) ; Ball, Craig A.; (San Carlos,
CA) ; Elkins, Jeffrey M.; (Woodside, CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
FlowMedica, Inc.
Fremont
CA
|
Family ID: |
35056678 |
Appl. No.: |
11/073421 |
Filed: |
March 4, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60550632 |
Mar 4, 2004 |
|
|
|
60550774 |
Mar 5, 2004 |
|
|
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Current U.S.
Class: |
604/96.01 ;
604/43 |
Current CPC
Class: |
A61M 25/0662 20130101;
A61M 25/0032 20130101; A61M 25/007 20130101 |
Class at
Publication: |
604/096.01 ;
604/043 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. A single lumen introducer sheath for accessing at least one
renal artery and at least one peripheral blood vessel of a patient,
the introducer sheath comprising: a proximal hub comprising first
and second ports; a lumen extending from the first and second ports
and having sufficient length such that when the ports are
positioned outside the patient a distal end of the lumen is
positionable in an abdominal aorta at or near origins of the
patient's renal arteries; a proximal aperture in the lumen,
configured to allow passage of a vascular catheter device through
the proximal aperture and into or through an iliac artery
contralateral to an insertion point of the introducer sheath into
the patient; and a distal aperture at the distal end of the lumen,
configured to allow passage of a bifurcated renal catheter device
out of the distal aperture to enter at least one of the renal
arteries.
2. An introducer sheath as in claim 1, wherein the proximal
aperture comprises a side aperture in the lumen.
3. A dual lumen introducer sheath for accessing at least one renal
artery and at least one peripheral blood vessel of a patient, the
introducer sheath comprising: a proximal hub comprising first and
second ports; a first lumen extending from the first port to a
first distal aperture and having sufficient length such that when
the first port is positioned outside the patient the first distal
aperture is positionable in an abdominal aorta at or near origins
of the patient's renal arteries; and a second lumen extending from
the second port to a second distal aperture and having a shorter
length than the length of the first lumen, wherein the second lumen
is configured to allow passage of a catheter device through the
second lumen and into or through an iliac artery contralateral to
an insertion point of the introducer sheath into the patient.
4. An introducer sheath as in claim 3, wherein the first and second
lumens are disposed side-by-side in a proximal portion of the
introducer sheath, and wherein the first lumen extends beyond the
proximal portion.
5. An introducer sheath as in claim 3, wherein the first lumen is
configured to accept a bifurcated catheter for delivering one or
more substances into the renal arteries.
6. An introducer sheath as in claim 3, wherein the second lumen is
configured to accept a balloon angioplasty catheter device for
performing an angioplasty procedure in one or more peripheral
arteries.
7. A method for advancing at least two catheter devices into
vasculature of a patient, the method comprising: positioning a
single lumen introducer sheath in the patient such that the sheath
extends from a proximal, two-port hub outside the patient into one
of the patient's iliac arteries, and thus to a distal end in an
abdominal aorta at or near origins of renal arteries of the
patient; advancing a bifurcated renal artery catheter device
through the distal end of the sheath's lumen to extend into the
renal arteries; and advancing a vascular catheter device through a
proximal aperture in the lumen into at least one peripheral vessel
of the patient on a contralateral side of the patient relative to
an insertion point of the sheath.
8. A method as in claim 7, further comprising delivering at least
one substance into at least one of the renal arteries through the
bifurcated renal artery catheter device.
9. A method as in claim 8, wherein the at least one substance is
selected from the group consisting of vasodilators, saline,
diuretics, hyper-oxygenated blood, hyper-oxygenated blood
substitutes and filtered blood.
10. A method as in claim 8, further comprising delivering at least
one additional substance into peripheral vessel(s) of the patient
through the vascular catheter device.
11. A method as in claim 10, wherein the additional substance
comprises a radiocontrast agent.
12. A method as in claim 10, further comprising performing an
interventional procedure in at least one peripheral vessel of the
patient, using the vascular catheter device.
13. A method as in claim 12, wherein the interventional procedure
comprises an angioplasty procedure.
14. A method for advancing at least two catheter devices into
vasculature of a patient, the method comprising: positioning a dual
lumen introducer sheath in the patient such that the sheath extends
from a proximal hub outside the patient into one of the patient's
iliac arteries, and thus to a first distal aperture of a first
lumen in an abdominal aorta at or near origins of renal arteries of
the patient and to a second distal aperture of a second lumen in or
near the iliac artery in which the sheath is positioned; advancing
a bifurcated renal artery catheter device through the first lumen
and first distal aperture to extend into the renal arteries; and
advancing a vascular catheter device through the second lumen and
second distal aperture into at least one peripheral vessel of the
patient on a contralateral side of the patient relative to an
insertion point of the sheath.
15. A method as in claim 14, further comprising delivering at least
one substance into at least one of the renal arteries through the
bifurcated renal artery catheter device.
16. A method as in claim 15, wherein the at least one substance is
selected from the group consisting of vasodilators, saline,
diuretics, hyper-oxygenated blood, hyper-oxygenated blood
substitutes and filtered blood.
17. A method as in claim 15, further comprising delivering at least
one additional substance into peripheral vessel(s) of the patient
through the vascular catheter device.
18. A method as in claim 17, wherein the additional substance
comprises a radiocontrast agent.
19. A method as in claim 17, further comprising performing an
interventional procedure in at least one peripheral vessel of the
patient, using the vascular catheter device.
20. A method as in claim 19, wherein the interventional procedure
comprises an angioplasty procedure.
21. A system for accessing at least one renal artery and at least
one peripheral blood vessel of a patient, the system comprising: a
single lumen introducer sheath comprising: a proximal hub
comprising first and second ports; a lumen extending from the first
and second ports and having sufficient length such that when the
ports are positioned outside the patient a distal end of the lumen
is positionable in an abdominal aorta at or near origins of the
patient's renal arteries; a proximal aperture in the lumen,
configured to allow passage of a vascular catheter device through
the proximal aperture and into or through an iliac artery
contralateral to an insertion point of the introducer sheath into
the patient; and a distal aperture at the distal end of the lumen,
configured to allow passage of a bifurcated renal catheter device
out of the distal aperture to enter at least one of the renal
arteries. a bifurcated renal artery catheter device for advancing
through the first lumen to access the renal arteries; and a
vascular catheter device for advancing through the second lumen and
into or through the contralateral iliac artery.
22. A system as in claim 21, wherein the bifurcated renal artery
catheter device is configured to expand from a constrained
configuration within the introducer sheath to a deployed
configuration in which two oppositely directed distal ends are
positioned within the two renal arteries or the patient.
23. A system as in claim 22, wherein one of the two distal ends
includes an aperture for allowing passage of fluid from the
bifurcated renal artery catheter into one of the renal
arteries.
24. A system as in claim 22, wherein each of the two distal ends
includes an aperture for allowing passage of fluid from the
bifurcated renal artery catheter into each of the renal
arteries.
25. A system as in claim 21, wherein the vascular catheter device
comprises a balloon angioplasty catheter.
26. A system for accessing at least one renal artery and at least
one peripheral blood vessel of a patient, the system comprising: a
dual lumen introducer sheath comprising: a proximal hub comprising
first and second ports; a first lumen extending from the first port
to a first distal aperture and having sufficient length such that
when the first port is positioned outside the patient the first
distal aperture is positionable in the abdominal aorta at or near
origins of the patient's renal arteries; and a second lumen
extending from the second port to a second distal aperture and
having a shorter length than the length of the first lumen, wherein
the second lumen is configured to allow passage of a catheter
device through the second lumen and into or through an iliac artery
contralateral to an insertion point of the introducer sheath into
the patient; a bifurcated renal artery catheter device for
advancing through the first lumen to access the renal arteries; and
a vascular catheter device for advancing through the second lumen
and into or through the contralateral iliac artery.
27. A system as in claim 26, wherein the first and second lumens of
the sheath are disposed side-by-side in a proximal portion of the
introducer sheath, and wherein the first lumen extends beyond the
proximal portion.
28. A system as in claim 26, wherein the bifurcated renal artery
catheter device is configured to expand from a constrained
configuration within the introducer sheath to a deployed
configuration in which two oppositely directed distal ends are
positioned within the two renal arteries or the patient.
29. A system as in claim 28, wherein one of the two distal ends
includes an aperture for allowing passage of fluid from the
bifurcated renal artery catheter into one of the renal
arteries.
30. A system as in claim 28, wherein each of the two distal ends
includes an aperture for allowing passage of fluid from the
bifurcated renal artery catheter into each of the renal
arteries.
31. A system as in claim 26, wherein the vascular catheter device
comprises a balloon angioplasty catheter.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims priority to U.S. Provisional
Patent Application Nos.: 60/550,632 (original attorney docket
number FLO5360.56P1), filed Mar. 4, 2004, and 60/550,774, (original
attorney docket number FLO5360.56P2), filed Mar. 5, 2004, the full
disclosures of which are hereby incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention is related to medical devices, methods
and systems. More specifically, the invention is related to
devices, methods and systems for accessing various blood vessels in
a patient, such as one or both renal arteries and one or more
peripheral vessels.
[0003] In the setting of interventional radiology, numerous
conditions exist that warrant placement of various intravascular
devices into the lower limb arteries (iliac, femoral, popliteal,
etc.). Such devices may include catheters and guidewires for
diagnostic purposes, or systems for therapeutic or prophylactic
applications such as drug infusion, monitoring/sampling,
angioplasty and stenting, possibly in conjunction with embolic
protection. In any event, these procedures often involve the use of
radiocontrast agents known to have detrimental effects on renal
function.
[0004] In many instances, lower limb arteries intended for
diagnosis or intervention are accessed via an "up-and-over"
approach, which first involves gaining arterial access on one side
of the patient, typically though not necessarily via a femoral
artery. From that access point, one or more diagnostic,
prophylactic, and/or treatment devices are advanced in a retrograde
fashion through the iliac artery on the side of access to the
aortic bifurcation and then down along the direction of blood flow
on the contralateral side, through the contralateral iliac artery,
into and possibly through the contralateral femoral artery, etc. to
the site of treatment and/or diagnostic procedure. As mentioned
above, performing the treatment and/or diagnostic procedure often
involves injection of a radiocontrast agent to allow the
physician(s) to visualize the treatment/diagnostic site.
[0005] The nephrotoxicity of radiocontrast agents has been well
established. In patients with known risk factors, radiocontrast
nephropathy (RCN) is a prevalent adverse effect of interventional
procedures utilizing organically bound iodine-based contrast
imaging agents. While the full mechanism of RCN is not known, its
detrimental results on morbidity and mortality are well documented,
and it is hypothesized that local agent administration to the renal
arteries during the time of contrast media exposure may mitigate
the development of RCN. Agents in this case may include
vasodilators, diuretics, or hyper-oxygenated blood or blood
substitute. As well as agent infusion, the exchange of blood laden
with contrast media and replacement of it with filtered blood, via
use of an external blood filter/pump might be warranted.
[0006] Various apparatus and methods for providing local delivery
of substances to renal arteries have be described by the inventors
of the present invention in U.S. patent application Ser. No.
09/724,691 (Attorney Docket No. FLO5360.3A), filed Nov. 28, 2000;
Ser. No. 10/422,624 (Attorney Docket No. FLO5360.03.A1), filed Apr.
23, 2003; Ser. No. 10/251,915 (Attorney Docket No. FLO5360.05A),
filed Sep. 20, 2002; Ser. No. 10/636,359 (Attorney Docket No.
FLO5360.05A1), filed Aug. 6, 2003; and Ser. No. 10/636,801
(Attorney Docket No. FLO5360.05A2), filed Aug. 6, 2003, the full
disclosures of which are all incorporated herein by reference.
Apparatus and methods for renal delivery of substances have also
been described in PCT Patent Application Nos.: PCT/US03/029744
(Attorney Docket No. FLO5360.48FP), filed Sep. 22, 2003;
PCT/US03/29995 (Attorney Docket No. FLO5360.49FP), filed Sep. 22,
2003; PCT/US03/29743 (Attorney Docket No. FLO5360.50FP), filed Sep.
22, 2003; and PCT/US03/29585 (Attorney Docket No. FLO5360.51FP),
filed Sep. 22, 2003, the full disclosures of which are all
incorporated herein by reference.
[0007] For the reasons described above, in some diagnostic and
treatment procedures performed in the peripheral vasculature,
especially in patients with renal risk factors, it may be desirable
to concurrently provide for a means of renal protection via
site-specific agent delivery to the renal arteries. Thus, a need
exists for devices, methods and systems that provide access to one
or more renal arteries and to one or more peripheral vessels.
Ideally, such devices, methods and systems would allow for access
and substance delivery through a common introducer device that
provides access via a femoral artery. At least some of these
objectives will be met by the present invention.
BRIEF SUMMARY OF THE INVENTION
[0008] In one aspect of the present invention, a single lumen
introducer sheath for accessing at least one renal artery and at
least one peripheral blood vessel of a patient includes a proximal
hub comprising first and second ports and a lumen extending from
the ports and having proximal and distal apertures. The lumen
extends from the first and second ports and has sufficient length
such that when the ports are positioned outside the patient a
distal end of the lumen is positionable in the abdominal aorta at
or near origins of the patient's renal arteries. The proximal
aperture in the lumen is configured to allow passage of a vascular
catheter device through the proximal aperture and into or through
an iliac artery contralateral to an insertion point of the
introducer sheath into the patient. The distal aperture at the
distal end of the lumen is configured to allow passage of a
bifurcated renal catheter device out of the distal aperture to
enter at least one of the renal arteries. Typically, though not
necessarily, the proximal aperture comprises a side aperture in the
lumen.
[0009] For purposes of the present application, the term
"contralateral" refers to the side of the patient that is opposite
the side in which an introducer sheath is placed. Various
embodiments of the sheath described herein may be placed on either
side of a patient, typically though not necessarily via a femoral
artery access site. Thus, in one example where a sheath is inserted
into a patient's right femoral artery, then the left side of the
patient's body would be the contralateral side. If a sheath is
inserted into a patient's left femoral artery, then the
contralateral side is the right side.
[0010] In another aspect of the present invention, a dual lumen
introducer sheath for accessing at least one renal artery and at
least one peripheral blood vessel of a patient includes a proximal
hub comprising first and second ports, a first lumen, and a second
lumen. The first lumen extends from the first port to a first
distal aperture and has sufficient length such that when the first
port is positioned outside the patient the first distal aperture is
positionable in the abdominal aorta at or near origins of the
patient's renal arteries. The second lumen extends from the second
port to a second distal aperture and has a shorter length than the
length of the first lumen. The second lumen is configured to allow
passage of a catheter device through the second lumen and into or
through an iliac artery contralateral to an insertion point of the
introducer sheath into the patient.
[0011] In some embodiments, the first and second lumens are
disposed side-by-side in a proximal portion of the introducer
sheath, and the first lumen extends beyond the proximal portion. In
some embodiments, the first lumen is configured to accept a
bifurcated catheter for delivering one or more substances into the
renal arteries. The second lumen may be configured to accept, for
example, a balloon angioplasty catheter device for performing an
angioplasty procedure in one or more peripheral arteries.
[0012] In another aspect of the present invention, a method for
advancing at least two catheter devices into vasculature of a
patient first involves positioning a single lumen introducer sheath
in the patient such that the sheath extends from a proximal,
two-port hub outside the patient into one of the patient's iliac
arteries, and thus to a distal end in an abdominal aorta at or near
origins of renal arteries of the patient. Next, a bifurcated renal
artery catheter device is advanced through the distal end of the
sheath's lumen to extend into the renal arteries, and a vascular
catheter device is advanced through a proximal aperture in the
lumen into at least one peripheral vessel of the patient on a
contralateral side of the patient relative to an insertion point of
the sheath. In various embodiments, the vascular catheter may be
advanced through the introducer sheath before or after the renal
catheter is advanced.
[0013] In some embodiments, the method further involves delivering
at least one substance into at least one of the renal arteries
through the bifurcated renal artery catheter device. For example,
substances which may be delivered through the renal artery catheter
device include, but are not limited to, vasodilators, diuretics,
hyper-oxygenated blood, hyper-oxygenated blood substitutes and
filtered blood. In some embodiments, the method further involves
delivering at least one additional substance into peripheral
vessel(s) of the patient through the vascular catheter device. For
example, such an additional substance may include, but is not
limited to, a radiocontrast agent. Optionally, the method may
further include performing an interventional procedure in at least
one peripheral vessel of the patient, using the vascular catheter
device. One example of such a procedure is an angioplasty
procedure.
[0014] In another aspect of the present invention, a method for
advancing at least two catheter devices into vasculature of a
patient involves positioning a dual lumen introducer sheath in the
patient such that the sheath extends from a proximal hub outside
the patient into one of the patient's iliac arteries, and thus to a
first distal aperture of a first lumen in the abdominal aorta at or
near origins of renal arteries of the patient and to a second
distal aperture of a second lumen in or near the iliac artery in
which the sheath is positioned. The method then involves advancing
a bifurcated renal artery catheter device through the first lumen
and first distal aperture to extend into the renal arteries. The
method then involves advancing a vascular catheter device through
the second lumen and second distal aperture into at least one
peripheral vessel of the patient on a contralateral side of the
patient relative to an insertion point of the sheath. Again, in
various embodiments, the vascular catheter may be advanced through
the sheath either before or after the renal catheter is
advanced.
[0015] In another aspect of the invention, a system for accessing
at least one renal artery and at least one peripheral blood vessel
of a patient includes a single lumen introducer sheath, a
bifurcated renal artery catheter device for advancing through the
first lumen to access the renal arteries, and a vascular catheter
device for advancing through the second lumen and into or through
the contralateral iliac artery. The single lumen sheath includes a
proximal hub, a lumen, a proximal aperture in the lumen, and a
distal aperture at the distal end of the lumen, as described above.
The sheath may include any of the features previously
described.
[0016] In some embodiments, the bifurcated renal artery catheter
device is configured to expand from a constrained configuration
within the introducer sheath to a deployed configuration in which
two oppositely directed distal ends are positioned within the two
renal arteries or the patient. In some embodiments, one of the two
distal ends includes an aperture for allowing passage of fluid from
the bifurcated renal artery catheter into one of the renal
arteries. In alternative embodiments, each of the two distal ends
includes an aperture for allowing passage of fluid from the
bifurcated renal artery catheter into one of the renal arteries.
The vascular catheter may comprise any diagnostic and/or treatment
catheter device suitable for accessing and performing a function in
a blood vessel. In one embodiment, for example, the vascular
catheter device comprises a balloon angioplasty catheter.
[0017] In another aspect of the present invention, a system for
accessing at least one renal artery and at least one peripheral
blood vessel of a patient includes a dual lumen introducer sheath,
a bifurcated renal artery catheter device for advancing through the
first lumen to access the renal arteries, and a vascular catheter
device for advancing through the second lumen and into or through
the contralateral iliac artery. The dual lumen introducer sheath
includes a proximal hub, a first lumen, and a second lumen, as
described above. The introducer sheath may include any of the
features previously described.
[0018] These and other aspects and embodiments of the invention
will be described in further detail below, with reference to the
attached drawing figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a side view of a dual lumen sheath and catheter
system for accessing renal arteries and peripheral vessels, shown
in situ, according to one embodiment of the present invention.
[0020] FIG. 2 is a side view of a dual lumen sheath for providing
access to renal arteries and peripheral vessels, according to one
embodiment of the present invention.
[0021] FIGS. 2A and 2B are end-on cross-sectional views of the dual
lumen sheath of FIG. 2, at different points along the length of the
sheath.
[0022] FIG. 2C is an end-on cross-sectional view a dual lumen
sheath, according to an alternative embodiment of the present
invention.
[0023] FIG. 3 is a side view of a single lumen sheath and catheter
system for accessing renal arteries and peripheral vessels,
according to an alternative embodiment of the present
invention.
[0024] FIG. 4 is a side view of the single lumen sheath of FIG.
3.
[0025] FIG. 5 is a side view of a bifurcated renal artery catheter
device for use with a sheath of the present invention, according to
one embodiment.
DETAILED DESCRIPTION OF THE INVENTION
[0026] Referring to FIG. 1, a vascular access system 10 in one
embodiment suitably includes a dual lumen introducer sheath 12, a
bifurcated renal catheter 14 and an additional vascular catheter
device 16. As will be described in further detail below, in
alternative embodiments, introducer sheath 12 may have only one
lumen, with distal and proximal apertures. In the embodiment shown
in FIG. 1, introducer sheath 12 includes a proximal hub 18 having
two having first and second ports 24, 26, a first lumen 20 in fluid
communication with first port 24 and a first distal aperture 28,
and a second lumen 22 in fluid communication with second port 26
and a second distal aperture 30. Introducer sheath 12 is typically,
though not necessarily, introduced into a patient through a femoral
artery and advanced into an iliac artery, which in FIG. 1 is
referred to as the ipsilateral iliac artery II. Upon positioning of
sheath 12, first lumen 20 extends into the patients aorta A such
that first distal aperture 28 locates at or near the origins of the
patient's renal arteries R, which lead from the aorta A to the
kidneys K. Meanwhile, second lumen 22 ends more proximally in
second distal aperture 30, which upon positioning of sheath 12
typically resides in or near the ipsilateral iliac artery II.
[0027] Introducer sheath 12 is generally adapted to be placed at
the desired in-vivo location via traditional vascular access
technique. After this placement, bifurcated renal artery catheter
14 is delivered into first entry port 24 on hub 18 and advanced
through first lumen 20 to extend out first distal aperture 28, such
that each of its two branches is positioned within a renal artery
R. In various embodiments, bifurcated renal artery catheter 14 may
be any of a number of suitable renal catheter devices, many
examples of which are described in the patent applications
incorporated by reference above in the background section. In some
embodiments, bifurcated catheter 14 may be adapted to access both
renal arteries, while in alternative embodiments only one renal
artery may be accessed, and the opposite arm of the bifurcated
catheter may act as an anchor or support. Once it is placed in a
desired position, bifurcated renal artery catheter 14 may be used
to selectively infuse one or more agents, typically renal
protective agents, into the renal arteries. Such agents may
include, but are not limited to, vasodilators, saline, diuretics,
hyper-oxygenated blood, hyper-oxygenated blood substitutes and
filtered blood. In other embodiments, other agent(s) may be used
prevent or reduce negative effects of one or more radiocontrast
agents that are subsequently or simultaneously delivered elsewhere.
In some embodiments, system 10 may include a source of such
agent(s).
[0028] In some embodiments, once renal catheter 14 is positioned,
vascular catheter device 16 may then be advanced into second entry
port 26 on hub 18, advanced through second lumen 22 and second
distal aperture 30, and further advanced into and possibly through
the contralateral iliac artery CI. Depending on the desired
treatment and/or diagnosis site, vascular catheter 16 may be
advanced into the contralateral femoral artery or through the
contralateral femoral artery into one or more peripheral vessels.
Vascular catheter device 16 itself may comprise any of a number of
suitable devices, such as an a balloon angioplasty catheter (as
shown), an atherectomy catheter, an ultrasound catheter, an
infusion catheter or the like. Once placed in a desired position in
the contralateral peripheral vasculature of the patient, vascular
catheter 16 may then be used to perform one or more diagnostic
and/or therapeutic procedures. Many of such procedures involve the
introduction of one or more radiocontrast dyes or agents, and any
adverse effects of such agents on the kidneys K will be mitigated
by the substance(s) delivered via bifurcated renal artery catheter
14.
[0029] In various embodiments, system 10 may include additional,
fewer and/or alternative components or devices. Furthermore, in
various embodiments of a method for using system 10, the various
steps may be performed in a different order and/or steps may be
added or eliminated. For example, in one embodiment, a renal
protective substance may be delivered via renal catheter 14 at the
same time that a radiocontrast agent is delivered via vascular
catheter 16. In another embodiment, the method may involve multiple
infusions of renal protective substance(s) and/or multiple
infusions of radiocontrast material(s) in any of a number of
different orders. Thus, the described method is but one preferred
way in which vascular access system 10 may be used.
[0030] With reference now to FIG. 2-2C, dual lumen introducer
sheath 12 is shown in greater detail. Again, sheath includes
Y-shaped proximal hub 18, which allows for introduction of multiple
(in the exemplary case two) devices simultaneously. In some
embodiments, hub 18, first lumen 20 and second lumen 22 may each be
sized to allow passage of devices up to about 10 French in outer
diameter, or possibly even more, with a preferrered embodiment
being compatible with a renal catheter via first lumen 20 and a 5
Fr. to 8 Fr. peripheral diagnostic or interventional catheter via
second lumen 22. FIG. 2A shows a cross-section of first lumen 20,
FIG. 2B shows a cross-section of first and second lumens 20, 22, in
a more proximal portion of sheath 12, and FIG. 2C shows a
cross-section of an alternative embodiment of the more proximal
portion, with a different design of first and second lumens 20, 22.
The overall usable length of sheath 12 is generally such that it
allows for standard femoral access (or other access point), and
also allows first distal aperture 28 in first lumen 20 to reach a
location at or near the renal arteries in order to deliver the
bifurcated renal catheter. Again, various lengths for this device
may also be provided to suit individual patients' anatomies, such
as in a kit that allows for a particular device to be chosen for a
particular case. Should an independently collapsible and expandable
renal catheter be employed, the sheath's overall length may be
reduced as desired.
[0031] Because sheath 12 may be delivered to the peri-renal aorta,
past the aortic bifurcation, sheath 12 may be further adapted to
allow for the diagnostic or interventional device performing the
lower limb procedure to exit along its length at a pre-determined
or variable location so as to allow for the "up-and-over" delivery
about the aortic bifurcation as previously discussed. In one
particular embodiment, this may involve an aperture or other
opening in the side wall of sheath 12 at an appropriate point. In
an alternative embodiment, as shown in FIGS. 1-2C and as described
above, a dual-lumen design may be adapted to deliver one device to
the peri-renal aorta and the other to the area of the bifurcation.
In a further embodiment, a valve apparatus (or multiple
apparatuses) in combination with one or both of the other designs
may be employed. In any event, sheath 12 may provide a mechanism
for delivering one device (such as for example the renal catheter)
to the level of the peri-renal aorta while simultaneously or
contemporaneously allowing for another device (such as for example
the peripheral diagnostic or interventional device) to exit lower
at the area of the bifurcation. In the case of an independently
collapsible and expandable renal catheter, a shorter sheath may be
used that reaches just to or below to the level on the aortic
bifurcation (i.e., still in the iliac artery on the side of
access). Both devices may be simultaneously or contemporaneously
deployed to their respective sites.
[0032] Referring now to FIGS. 3 and 4, an alternative embodiment of
a vascular access system 50 and a single lumen introducer sheath 52
are shown. In FIG. 3, vascular access system includes single lumen
introducer sheath 52, a bifurcated renal catheter 60 and a vascular
catheter device 62, which in this example is a balloon angioplasty
device. Single lumen sheath 52 includes a hub 54 with first 56 and
second 58 ports and connected to a fluid infusion device 68, and a
single lumen 53 having a proximal aperture 66, a distal aperture
64, and two radiopaque markers 51 for facilitating visualization of
the proximal aperture 66 location. In this embodiment, renal
catheter 60 and vascular catheter 62 are as described previously
above, but in various embodiments any suitable alternative devices
may be substituted.
[0033] A method for using system 50 is much the same as the method
described above with reference to FIG. 1. Sheath 52 is placed via a
femoral artery using a standard technique or any other desired
access technique, such that distal aperture 64 is positioned at or
near the ostia of the renal arteries. Renal catheter 60 may then be
inserted through first port 56 and advanced through lumen 53 and
distal aperture 64 to position its branches 65 within the renal
arteries. Before, after or simultaneously with that step, vascular
catheter 62 is inserted through second port 58 and advanced through
lumen 53 and proximal aperture 66 to extend into the contralateral
iliac artery and as far peripherally as desired by the physician.
One or more renal substances are then infused into the renal
arteries via renal catheter 60, and a radiocontrast substance is
infused into the peripheral vessel(s) via vascular catheter 62. In
some embodiments, vascular catheter 62 is then used to perform a
procedure in one or more vessels. Optionally, infusion device 68
may be used to deliver one or more substances into lumen 53.
[0034] FIG. 4 shows single lumen introducer sheath 52 in greater
detail. Radiopaque markers 51 may be placed in any of a number of
various configurations and locations in various embodiments, to
facilitate visualization and localization of proximal aperture 66,
distal aperture 64 and/or any other features of sheath 52.
[0035] Referring now to FIG. 5, a distal portion of bifurcated
renal catheter 14 includes two branches 15, 17, each including a
distal aperture 11, 13, and a proximal catheter body. Each branch
15, 17 provides a means to deliver one or more substances to the
renal artery in which it is placed. Overall usable length of the
renal catheter 14 would generally be such that renal access from a
typical femoral artery vascular access point (or other access
point) is achieved without an undue length of catheter remaining
outside of the patient. Again, various embodiments and features of
bifurcated renal catheters are described more fully in U.S. patent
application Ser. Nos. 09/724,691, 10/422,624, 10/251,915,
10/636,359 and 10/636801, and in PCT Patent Application Nos.
PCT/US03/029744, PCT/US03/29995, PCT/US03/29743 and PCT/US03/29585,
which were previously incorporated by reference.
[0036] Renal catheter 14 may be delivered in a collapsed condition
via sheath 12 to the abdominal aorta in the vicinity of the renal
arteries. Once deployed, it may expand to contact the walls of the
vessel, in an attempt to regain the shape configuration as
demonstrated above. This expansion and contraction may be active or
passive, as desired, based on the design of renal catheter 14. For
the purposes of illustration, the device is considered to be in its
free state as pictured in FIG. 3 and compressed via the constraint
of the introducer sheath 12 or other means during delivery. Thus
renal catheter 14 would "self-expand" upon deployment, to an extent
determined by the constraint of the blood vessel. However, renal
catheter 14 could alternatively be designed to have the collapsed
condition as default and be actively opened once deployed. Such may
be accomplished for example by use of integrated pull-wires, etc.
In any event, the outward contact with the blood vessel (aorta)
allows for easy cannulation of multiple vessels, as the device
naturally seeks its lower energy state by opening into branch
vessels.
[0037] When deployed in the aorta, in a procedure where it is
desired to access the renal arteries, renal catheter 14 will exit
introducer sheath 12, and branches 15, 17 will seek to open to
their natural, at-rest state. This will bias branches 15, 17 away
from each other and against the inner wall of the vessel, at
approximately 180.degree. apart from each other, more or less
centering catheter body 32 in the aorta. The proximal end of renal
catheter 14 may be manipulated via standard technique (i.e., the
use of a supplied "torque device" as is common with intravascular
guidewires) so that branches 15, 17 are more or less aligned near
the target renal arteries' ostia, and with a minimal amount of
axial or rotational manipulation, bilateral renal artery
cannulation can be achieved.
[0038] Previous disclosures by the inventors of the present
invention have also addressed the merits of various embodiments of
bifurcated renal catheters 14 in providing access to multiple
vessels simultaneously through a single vascular access point,
alone or in combination with other diagnostic or therapeutic
interventions or other procedures. For example, such disclosures
include U.S. Provisional Patent Application Nos.: 60/476,347
(Attorney Docket No. FLO5360.44P1), filed Jun. 5, 2003; 60/486,206
(Attorney Docket No. FLO5360.47P1, filed Jul. 9, 2003; 60/502,600
(Attorney Docket No. FLO5360.48P1), filed Sep. 13, 2003; 60/502,339
(Attorney Docket No. FLO5360.51P1), filed Sep. 13, 2003; 60/505,281
(Attorney Docket No. FLO5360.53P), filed Sep. 22, 2003; 60/493,100
(Attorney Docket No. FLO5360.54P1), filed Aug. 5, 2003; 60/502,468
(Attorney Docket No. FLO5360.54P2), filed Sep. 13, 2003; 60/543,671
(Attorney Docket No. FLO5360.55P1), filed Feb. 9, 2004; 60/550,632
(Attorney Docket No. FLO5360.56P1), filed Mar. 4, 2004; 60/550,774
(Attorney Docket No. FLO5360.56P2), filed Mar. 5, 2004; 60/571,057
(Attorney Docket No. FLO5360.57P1), filed May 14, 2004; 60/612,731
(Attorney Docket No. FLO5360.57P2), filed Sep. 24, 2004; and
60/612,801 (Attorney Docket No. FLO5360.60P1), filed Sep. 24, 2004,
the full disclosures of which are all hereby incorporated by
reference. Similar and alternative embodiments are described in PCT
Patent Application Nos.: PCT/US03/029744 (Attorney Docket No.
FLO5360.48FP), filed Sep. 22, 2003; PCT/US04/008573 (Attorney
Docket No. FLO5360.55FP), filed Mar. 19, 2004; PCT/US03/029586
(Attorney Docket No. FLO5360.54FP), filed Sep. 22, 2003; and
PCT/US03/029585 (Attorney Docket No. FLO5360.51FP), filed Sep. 22,
2003, the full disclosures of which are hereby incorporated by
reference.
[0039] Bifurcated renal catheter 14 may be similar to that
previously described in the above-referenced patent applications or
may have any other suitable design and features for bilateral renal
cannulation. The example provided and discussed herein for
illustration includes, without limitation, a passively
self-expanding branched assembly that uses outer sheath constraint
to allow delivery to the area of the renal arteries and then
expands upon delivery out of the sheath. However, in further
embodiments the catheter may also be of the type that is
independently collapsible and expandable, if so desired. Various
features may be further included. In one particular beneficial
embodiment, two distal arms are provided whose shapes and
flexibility profile allow for fast bilateral renal artery
cannulation with a minimum of required manipulation and such that
there is no induced vascular trauma. Exemplary catheter shaft and
distal arms may be in the range for example of about 1 Fr. to about
4 Fr. outer diameter. Exemplary arm lengths may be for example in
the range of about 2 cm to about 5 cm.
[0040] Dimensions and other particular features such as shape,
stiffness, etc. may be varied according to the scale of the
patient's anatomy, and thus a kit of devices may be provided from
which a healthcare provider may chose one particular device to meet
a particular need for a particular patient. For example, multiple
renal catheters may be provided having small, medium, and large
sizes, respectively. Upon being provided a particular patient
parameter, such as anatomical dimensions, a person could refer to
the device sizes offered and simply match the chosen size to the
parameter given. In this regard, a chart may be provided which
assists in matching a measured or estimated patient parameter with
the appropriate catheter choice.
[0041] Although the foregoing is a complete and accurate
description of various embodiments of the present invention, any of
a number of changes, additions or deletions may be made to one or
more embodiments without departing from the scope of the invention.
Therefore, the foregoing description is provided for exemplary
purposes and should not be interpreted to limit the scope of the
invention as set forth in the claims.
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