U.S. patent application number 12/123374 was filed with the patent office on 2008-10-02 for emboli protection devices and related methods of use.
Invention is credited to Andrew J. Dusbabek, Steven S. Hackett, Peter T. Keith, Scott A. Olson, THOMAS V. RESSEMANN, Dennis W. Wahr.
Application Number | 20080243171 12/123374 |
Document ID | / |
Family ID | 39877980 |
Filed Date | 2008-10-02 |
United States Patent
Application |
20080243171 |
Kind Code |
A1 |
RESSEMANN; THOMAS V. ; et
al. |
October 2, 2008 |
EMBOLI PROTECTION DEVICES AND RELATED METHODS OF USE
Abstract
An embolic protection system for treating a lesion in a blood
vessel is provided. The embolic protection system includes a guide
catheter, an evacuation sheath, a guidewire, and an infusion
catheter. The guide catheter has a guidewire lumen. The evacuation
sheath has an evacuation lumen and a sealing surface and is
configured to move within the lumen of the guide catheter. The
guidewire is configured to move within the lumen of the guide
catheter and the evacuation lumen. The infusion catheter has an
infusion lumen, at least one infusion port, and a guidewire lumen
configured to accept the guidewire, the infusion catheter guidewire
lumen being shorter than the guide catheter guidewire lumen.
Furthermore, the infusion catheter is configured to move within the
lumen of the guide catheter and the evacuation lumen over the
guidewire. The system may further comprise a dilation catheter
having a dilation balloon and a guidewire lumen.
Inventors: |
RESSEMANN; THOMAS V.; (St.
Cloud, MN) ; Hackett; Steven S.; (Maple Grove,
MN) ; Dusbabek; Andrew J.; (Dayton, MN) ;
Olson; Scott A.; (Zimmerman, MN) ; Keith; Peter
T.; (St. Paul, MN) ; Wahr; Dennis W.;
(Minnetonka, MN) |
Correspondence
Address: |
O''Melveny & Myers LLP;IP&T Calendar Department LA-1118
400 South Hope Street
Los Angeles
CA
90071-2899
US
|
Family ID: |
39877980 |
Appl. No.: |
12/123374 |
Filed: |
May 19, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09940986 |
Aug 29, 2001 |
7374560 |
|
|
12123374 |
|
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|
|
Current U.S.
Class: |
606/200 |
Current CPC
Class: |
A61B 17/12109 20130101;
A61B 2017/22082 20130101; A61B 2017/22079 20130101; A61F 2/95
20130101; A61B 2017/22084 20130101; A61B 17/12136 20130101; A61B
17/12045 20130101; A61B 17/22 20130101; A61B 2017/12127 20130101;
A61B 2217/007 20130101; A61B 90/39 20160201; A61B 2217/005
20130101; A61B 2017/22067 20130101 |
Class at
Publication: |
606/200 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. An embolic protection system for treating a lesion in a blood
vessel, comprising: a guide catheter having a guidewire lumen; an
evacuation sheath configured to move within the lumen of the guide
catheter and having an evacuation lumen and a sealing surface; a
guidewire configured to move within the lumen of the guide catheter
and the evacuation lumen; and an infusion catheter having an
infusion lumen, at least one infusion port, and a guidewire lumen
configured to accept the guidewire, the infusion catheter being
configured to move within the lumen of the guide catheter and the
evacuation lumen and over the guidewire, wherein the infusion
catheter guidewire lumen is shorter than the guide catheter
lumen.
2. The embolic protection system of claim 1, wherein the sealing
surface is configured to form a seal with the guide catheter.
3. The embolic protection system of claim 1, further comprising a
dilation catheter having a dilation balloon at a distal end and a
guidewire lumen, wherein the guidewire lumen of the dilation
catheter has a first cross-sectional dimension, and the infusion
catheter has a second cross-sectional dimension larger that the
first dimension.
4. The embolic protection system of claim 1, wherein the infusion
lumen has a first length and the guidewire lumen of the infusion
catheter has a second length shorter than the first length.
5. The embolic protection system of claim 1, wherein the infusion
catheter guidewire lumen has first and second open ends, and
wherein the guidewire lumen is sized such that when a first end of
the guidewire lumen is positioned distal to a distal end of the
guide catheter, the second end of the guidewire lumen is positioned
within the guide catheter.
6. An embolic protection system for treating a lesion in a blood
vessel, comprising: an evacuation sheath having an evacuation lumen
and a scaling surface; a guidewire configured to move within the
evacuation lumen; and an infusion catheter having an infusion
lumen, at least one infusion port, and a guidewire lumen configured
to accept the guidewire, the infusion catheter being configured to
move within the evacuation lumen and over the guidewire, wherein
the infusion lumen has a first length and the infusion catheter
guidewire lumen has a second length substantially shorter than the
first length.
7. The embolic protection system of claim 6, further comprising a
guide catheter having a guide lumen, wherein the infusion catheter
guidewire lumen is shorter than the guide lumen.
8. The embolic protection system of claim 6 further comprising a
guide catheter, wherein the infusion catheter guidewire lumen has
first and second open ends, and wherein the guidewire lumen is
sized such that when the first end of the guidewire lumen is
positioned distal to a distal end of the guide catheter, the second
end of the guidewire lumen is positioned within the guide catheter.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This is a divisional of U.S. patent application Ser. No.
09/940,986, filed on Aug. 29, 2001. This is also related to U.S.
patent application Ser. No. 09/845,162, filed on May 1, 2001, and
U.S. patent application Ser. No. 10/214,712, filed on Aug. 9, 2002.
The entire contents of each of the above-referenced applications
are expressly incorporated herein by reference in their
entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to apparatus and methods used
to prevent the introduction of emboli into the bloodstream during
and after surgery performed to reduce or remove blockage in blood
vessels.
BACKGROUND OF THE INVENTION
[0003] Narrowing or occlusion of blood vessels, such as the walls
of an artery, inhibit normal blood flow. Such blockages, whether
partial or full, can have serious medical consequences, depending
upon their location within a patient's vascular system. Narrowing
or blockage of the coronary vessels that supply blood to the heart,
a condition known as atherosclerosis, may cause damage to the
heart. Heart attacks (myocardial infarction) may also result from
this condition. Other vessels are also prone to narrowing,
including carotids, renals, cerebrals, and other peripheral
arteries.
[0004] Various surgical procedures are currently used to reduce or
remove the blockage in blood vessels. Such procedures include
balloon angioplasty, which involves inserting a balloon catheter
into the narrowed or occluded area, expanding the balloon in the
narrow or occluded area, and if necessary, placing a stent in the
now expanded area to keep it open. Another common procedure used is
atherectomy where the lesion is cut away and removed from the
vessel, or abrasively ground, sending the small particulates
downstream. Other endovascular procedures make use of thrombectomy,
drug delivery, radiation, stent-grafts, and various diagnostic
devices.
[0005] Another alternative is bypass surgery in which a section of
vein is removed from, for example, the patient's leg, e.g., a
saphenous vein, to be used as a graft to form a pathway to bypass
the occluded area. The saphenous vein graft (SVG), however, is also
susceptible to becoming occluded in a manner similar to that of the
bypassed vessel. In such a case, angioplasty (with or without the
use of a stent) or atherectomy is often used on the SVG to remove
or reduce the blockage.
[0006] Each of the above described procedures carries with it the
risk that some of the treated plaque will be disrupted, resulting
in embolic particulates released in the bloodstream. These emboli,
if allowed to flow through the vascular system, may cause
subsequent infarctions or ischemia in the patient. SVGs treated by
angioplasty or atherectomy carry a particularly high risk of this
result, but such problems are also encountered in the other types
of procedures mentioned, such as carotids, or native coronary
arteries, particularly those whose lesions include thrombus.
[0007] Several systems to prevent emboli being released into the
bloodstream during such procedures have been tried. One system uses
a balloon to totally occlude the artery distal (downstream) to the
area of blockage to be treated. In this system, a guidewire with a
balloon is introduced into the narrowed or occluded area, and
passes through the narrowed or occluded area to a position
downstream of the blockage. The balloon is inflated, the blockage
is reduced or removed, and then the blood proximal to the balloon
is withdrawn from the blood vessel to remove any particles or
emboli which have resulted from the reduction of the blockage.
While this system has shown a decrease in emboli related
complications in patients undergoing such treatments, the event
rate remains significant. One particular problem with this system
is passing the guidewire and balloon through the narrowed or
occluded area prior to occlusion with the balloon, creating the
risk that emboli will be produced as the balloon passes through the
blockage. Thus, any particulate or plaque disturbed during this
passage which forms emboli prior to inflation of the balloon is
free to flow through the vascular system, increasing the risk for
infarction or ischemia. Also, any debris or particulate matter
which gathers around the edges of the balloon may slip downstream
during deflation and retrieval of the balloon. In addition, this
system requires that blood flow be totally occluded in the vessel
for relatively prolonged intervals that may induce adverse cardiac
events. Although this may not be a problem clinically, many
patients perceive the occlusion of blood flow for this period of
time as problematic.
[0008] Another system used to prevent emboli being released into
the bloodstream during surgical intervention is a filter. As with
the occlusion balloon, the filter must pass through the narrowed or
occluded area and is deployed distal (downstream) to the blockage.
The filter then catches any particulate material generated during
the removal of the blockage. The filter offers the benefit that
blood flow is not totally occluded. However, because the filter
must pass through the blockage, it suffers from the same drawback
as the previous system--risk of the creation of emboli during
passage of the filter through the blockage. In addition, it is
difficult to deploy the filter securely against the walls of the
vessel to prevent flow around the filter and any debris or
particulate matter which gathers around the edges of the filter may
slip downstream during its retrieval. Also, in order to allow blood
flow during the procedure, the pores of the filter should be at
least 100 microns in diameter. The majority of emboli have a
diameter between about 40 microns and about 100 microns. Thus, the
filter will not catch the majority of emboli, which may flow
downstream and cause a infarction or ischemia. The filter also
cannot prevent the passage of certain neurohumoral or vasoactive
substances which are released into the blood during the procedure
and may contribute to generalized vasospasm of the distal coronary
tree.
[0009] Thus, there is a need for an improved system and method of
treating occluded vessels which can reduce the risk of distal
embolization during vascular interventions. There is also a need
for a system which reduces the amount of time that total occlusion
of the blood flow is necessary.
SUMMARY OF THE INVENTION
[0010] In accordance with the invention, methods and apparatuses
for reducing or removing a blockage within a vessel without
permitting embolization of particulate matter are provided. The
methods and apparatuses occlude blood flow for a minimal amount of
time and capture particulate matter created during each step of the
surgical process.
[0011] According to one aspect of the invention, a method of
treatment of a blood vessel is provided. The method includes
advancing an evacuation sheath assembly into the blood vessel,
prior to advancing a device across a stenosis to be treated,
stopping normal antegrade blood flow in the blood vessel proximate
to the stenosis, treating the stenosis while blood flow is stopped,
and inducing retrograde blood flow within the blood vessel to carry
embolic material dislodged during treating into the evacuation
sheath assembly.
[0012] According to another aspect of the invention, a method for
treating a diseased blood vessel is provided. The method includes
positioning a guide catheter proximate to the diseased blood
vessel, positioning an evacuation sheath assembly within the
diseased blood vessel, prior to advancing a device across a
diseased area of the blood vessel, stopping normal antegrade blood
flow in the blood vessel proximate to the diseased area, advancing
a guidewire through the guide catheter and the evacuation sheath
assembly across the diseased area of the blood vessel while the
blood flow is stopped, causing retrograde flow of blood within the
diseased blood vessel to remove embolic debris dislodged by
advancement of the guidewire, advancing an interventional catheter
into the blood vessel to treat the diseased area of the blood
vessel, and causing retrograde flow of blood within the vessel to
remove embolic debris dislodged by advancement of the
interventional catheter.
[0013] According to another aspect of the present invention, a
method of performing a procedure on a blood vessel is provided. The
method includes positioning a guide catheter proximate to the blood
vessel, positioning an evacuation sheath assembly within the guide
catheter, measuring pressure in the blood vessel to obtain a first
pressure measurement, creating a seal between the evacuation sheath
assembly and the blood vessel, measuring pressure in the blood
vessel to obtain a second pressure measurement, and comparing the
first and second pressure measurements.
[0014] According to yet another aspect of the invention, a method
of isolating fluid communication between a catheter and a blood
vessel to facilitate visualization of the blood vessel is provided.
The method includes advancing a catheter proximate to the blood
vessel, advancing an evacuation sheath assembly including a sealing
surface through the catheter and partially into the blood vessel,
expanding the sealing surface to create a seal between the blood
vessel and the evacuation sheath assembly thereby stopping normal
blood flow in the vessel, and injecting contrast dye into the blood
vessel while the normal blood flow is stopped.
[0015] According to one aspect of the present invention, an
evacuation sheath assembly is provided. The evacuation sheath
assembly includes a tube having first and second lumens and first
and second sealing surfaces, wherein the first lumen is an
evacuation lumen configured to be placed in fluid communication
with a bloodstream and wherein the second lumen is an inflation
lumen in fluid communication with at least one of the first and
second sealing surfaces, and a shaft in fluid communication with
the inflation lumen and configured to connect to an inflation
source.
[0016] According to another aspect of the invention, evacuation
sheath assembly is provided. The evacuation sheath assembly
includes an elongated tube defining an expandable evacuation lumen
having a compressed delivery configuration and an expanded
operational configuration, and a first sealing surface configured
to form a seal within a catheter and a second sealing surface
configured to form a seal with a blood vessel.
[0017] According to yet another aspect of the present invention, a
combination for isolating fluid communication between a blood
vessel and a catheter is provided. The combination includes a
catheter having a lumen, and an evacuation sheath assembly
configured to move within the lumen of the catheter and having an
evacuation lumen and first and second sealing surfaces.
[0018] According to another aspect of the present invention, an
evacuation sheath assembly comprises an elongated tube defining an
evacuation lumen having proximal and distal ends, a proximal
sealing surface at a proximal end of the tube configured to form a
seal with a catheter, and a distal sealing surface configured to
form a seal with a blood vessel.
[0019] According to a further aspect of the present invention, an
evacuation sheath assembly is provided. The evacuation sheath
assembly includes an elongated tube defining an evacuation lumen
having open proximal and distal ends and an inflation lumen having
an open proximal end and a closed distal end, and a first sealing
region on a proximal portion of the evacuation lumen and a second
sealing region on a distal portion of the evacuation lumen, wherein
at least one of the first and second sealing regions is in fluid
communication with the inflation lumen, and wherein the first
sealing region is expandable to a first diameter and the second
sealing region is expandable to a second diameter different than
the first diameter.
[0020] According to another aspect of the present invention, an
evacuation sheath assembly is provided and includes an elongated
tube defining an inflation lumen and an expandable evacuation lumen
having a compressed configuration and an expanded configuration,
and a plurality of expandable surfaces along a length of the tube,
wherein a most proximal expandable surface forms a proximal sealing
surface and wherein a most distal expandable surface forms a distal
sealing surface, and wherein expansion of the plurality of
expandable surfaces expands the evacuation lumen from the
compressed configuration to the expanded configuration.
[0021] According to another aspect of the present invention, an
evacuation sheath assembly is provided. The evacuation sheath
assembly includes an elongated sheath defining an evacuation lumen
having open proximal and distal ends, wherein the sheath is
expandable from a delivery configuration to an operational
configuration, a proximal hollow shaft connected to a proximal end
of the sheath, and an actuation wire connected to a distal end of
the sheath, the actuation wire being movable within said shaft from
a distal position to a proximal position to expand said sheath.
[0022] According to one aspect of the present invention, a method
of treatment of a blood vessel is provided. The method includes
advancing a guide catheter proximate to the blood vessel, advancing
an evacuation sheath assembly through the guide catheter and into
the blood vessel while retaining a proximal portion of the
evacuation sheath assembly within the a guide catheter, creating a
first seal between the proximal portion of the evacuation sheath
assembly and the guide catheter, creating a second seal between a
distal portion of the evacuation sheath assembly and the blood
vessel, stopping normal antegrade blood flow within the blood
vessel, treating a stenosis within the blood vessel, causing
retrograde flow within the blood vessel to thereby remove embolic
material dislodged during the treating and carried by the
retrograde flow into the evacuation sheath assembly, and
re-establishing normal antegrade blood flow within the blood
vessel.
[0023] According to another aspect of the present invention, an
evacuation sheath assembly is provided. The evacuation sheath
assembly includes an elongated tube defining an expandable
evacuation lumen having first a first delivery configuration and a
second operational configuration, and a sealing surface on a distal
portion of the evacuation lumen, the sealing surface having a
non-sealing configuration that corresponds to the first delivery
configuration and a sealing configuration that corresponds to the
second operational configuration, wherein the sealing configuration
is configured to create a seal with a blood vessel.
[0024] According to another aspect of the present invention, an
evacuation sheath assembly is provided. The evacuation sheath
assembly includes an elongated tube defining an evacuation lumen
having open proximal and distal ends and an inflation lumen having
an open proximal end and a closed distal end, at least one
inflatable sealing surface in fluid communication with the
inflation lumen, and a soft steerable tip on a distal end of the
elongated tube.
[0025] According to yet another aspect of the present invention, an
evacuation sheath assembly includes an elongated tube defining an
evacuation lumen having open proximal and distal ends and an
inflation lumen having an open proximal end and a closed distal
end, and at least one inflatable sealing surface in fluid
communication with the inflation lumen, wherein the open distal end
of the evacuation lumen is angled.
[0026] According to another aspect of the present invention, an
evacuation sheath assembly is provided and includes an elongated
tube defining an evacuation lumen having open proximal and distal
ends and an inflation lumen having an open proximal end and a
closed distal end, and first and second sealing surfaces on the
tube, wherein the open proximal end of the evacuation lumen is
angled.
[0027] According to a further aspect of the present invention, an
evacuation sheath assembly includes an elongated tube defining an
evacuation lumen having open proximal and distal ends and an
inflation lumen having an open proximal end and a closed distal
end, and at least one inflatable sealing surface in fluid
communication with the inflation lumen, wherein the evacuation
lumen is shorter than the inflation lumen.
[0028] According to another aspect of the invention, an evacuation
sheath assembly is provided and includes an elongated tube defining
an evacuation lumen having open proximal and distal ends and an
inflation lumen having an open proximal end and a closed distal
end, and at least one inflatable sealing surface in fluid
communication with the inflation lumen, wherein a proximal portion
of the evacuation lumen has a first diameter and a distal portion
of the evacuation lumen has a second diameter larger than the first
diameter.
[0029] According to another aspect of the present invention, a
method for treating a diseased blood vessel is provided. The method
includes positioning a guide catheter within the ostium of a target
vessel, advancing an evacuation sheath assembly through the guide
catheter and beyond a major side branch of the target vessel,
forming a first seal between the target vessel and a distal portion
of the evacuation sheath assembly, forming a second seal between
the catheter and a proximal portion of the evacuation sheath
assembly, and advancing an interventional device through a lumen of
the evacuation sheath assembly to treat the target vessel.
[0030] According to another aspect of the present invention, a
method of treatment of a blood vessel is provided. The method
includes advancing an evacuation sheath assembly into the blood
vessel, stopping normal antegrade blood flow in the blood vessel
proximate to the stenosis, advancing a therapeutic catheter into
the blood vessel, treating the stenosis with the therapeutic
catheter, advancing an infusion catheter to a location distal to
the stenosis, infusing the blood vessel with a fluid supplied by
the infusion catheter, and inducing retrograde flow within the
blood vessel to carry embolic material dislodged during treating
into the evacuation sheath assembly.
[0031] According to another aspect of the invention, a method for
treating a blood vessel comprises positioning a guide catheter
proximate to the blood vessel, positioning an evacuation sheath
assembly within the blood vessel, stopping normal antegrade blood
flow in the blood vessel proximate to the site, advancing an
interventional catheter into the blood vessel to treat the site of
the blood vessel, occluding blood flow at the site with the
interventional catheter, permitting antegrade blood flow around the
guide catheter and evacuation sheath assembly toward the treatment
site while blood flow is occluded by the interventional catheter,
and applying a vacuum to the evacuation sheath assembly to carry
embolic debris and antegrade blood flow into the evacuation sheath
while blood flow is occluded by the interventional catheter.
[0032] According to yet another aspect of the invention, an
evacuation sheath assembly is provided. The assembly includes an
elongate hollow member having proximal and distal ends, first and
second lumens, and first and second sealing members, wherein the
proximal end is flared, and wherein the first lumen is an
evacuation lumen configured to be placed in fluid communication
with a bloodstream and wherein the second lumen is an inflation
lumen in fluid communication with at least one of the first and
second sealing members, and a shaft in fluid communication with the
inflation lumen and configured to connect to an inflation
source.
[0033] According to a further aspect of the invention, an
evacuation sheath assembly comprises an elongate hollow member
supported by a kink-resisting coil and having first and second
lumens, and first and second sealing members, wherein the first
lumen is an evacuation lumen configured to be placed in fluid
communication with a bloodstream and wherein the second lumen is an
inflation lumen in fluid communication with at least one of the
first and second sealing members, and a shaft in fluid
communication with the inflation lumen and configured to connect to
an inflation source.
[0034] According to another aspect of the invention, a combination
for isolating fluid communication between a blood vessel and a
catheter is provided. The combination includes a catheter having a
lumen, an obturator having a proximal end and a distal end, wherein
the distal end includes a distal tip having a first tapering
diameter, and an evacuation sheath assembly configured to move
within the lumen of the catheter and having an evacuation lumen and
first and second sealing members, wherein the evacuation sheath
assembly has a second diameter greater than the first tapering
diameter.
[0035] According to another aspect of the invention, a combination
for isolating fluid communication between a blood vessel and a
catheter includes a catheter having a lumen, and an evacuation
sheath assembly configured to move within the lumen of the catheter
and having an evacuation lumen and first and second sealing
members, wherein a proximal end of the evacuation lumen is
flared.
[0036] According to yet another aspect of the invention, a
combination for isolating fluid communication between a blood
vessel and a catheter comprises a catheter having a lumen, an
obturator having a proximal end and a distal end, wherein the
distal end includes a balloon and distal tip having a first
tapering diameter, and an evacuation sheath assembly configured to
move within the lumen of the catheter and having an evacuation
lumen and first and second sealing members, wherein the evacuation
sheath assembly has a second diameter greater than the first
tapering diameter.
[0037] According to another aspect of the invention, a method of
treatment of a blood vessel is provided. The method comprises
advancing a guide catheter proximate to the blood vessel, advancing
an evacuation sheath assembly through the guide catheter and into
the blood vessel while retaining a proximal portion of the
evacuation sheath assembly within the guide catheter, at least
partially occluding the coronary sinus, creating a seal between a
distal portion of the evacuation sheath assembly and the blood
vessel, stopping normal antegrade blood flow within the blood
vessel, treating a stenosis within the blood vessel; causing
retrograde flow within the blood vessel to thereby remove embolic
material dislodged during the treating and carried by the
retrograde flow into the evacuation sheath assembly, and
re-establishing normal antegrade blood flow within the blood
vessel.
[0038] According to a further aspect of the invention, an
evacuation sheath assembly is provided. The assembly includes an
elongated tube defining an evacuation lumen having open proximal
and distal ends and an inflation lumen having an open proximal end
and a closed distal end, and at least one inflatable sealing
surface in fluid communication with the inflation lumen, wherein
the open distal end of the evacuation lumen is perpendicular to a
longitudinal axis of the evacuation lumen.
[0039] According to another aspect of the invention, a combination
for isolating fluid communication between a blood vessel and a
catheter comprises a guide catheter having a lumen, an evacuation
sheath assembly configured to move within the lumen of the guide
catheter and having an evacuation lumen and first and second
sealing surfaces, and an infusion catheter assembly having an
infusion lumen and at least one infusion port, the infusion
catheter assembly being configured to move within the evacuation
lumen.
[0040] According to another aspect of the invention, an infusion
catheter assembly is provided. The infusion catheter assembly
comprises a proximal shaft portion having a proximal infusion
lumen, and a distal shaft portion connected to a distal end of the
proximal shaft portion, the distal shaft portion including a distal
infusion lumen in flow communication with the proximal infusion
lumen, at least one infusion port, and a guidewire lumen, wherein
the guidewire lumen is shorter than the combined length of the
proximal and distal infusion lumens.
[0041] According to yet another aspect of the invention, a method
of treatment of a blood vessel comprises advancing an evacuation
sheath assembly into the blood vessel, maintaining elevated
pressure in the coronary sinus, stopping normal antegrade blood
flow in the blood vessel proximate to the stenosis, treating the
stenosis, and inducing retrograde blood flow within the blood
vessel to carry embolic material dislodged during treating into the
evacuation sheath assembly.
[0042] According to a further aspect of the invention, a
combination for isolating fluid communication between a blood
vessel and a catheter includes a guide catheter having a lumen, an
evacuation sheath assembly configured to move within the lumen of
the guide catheter and having an evacuation lumen and first and
second sealing surfaces, and an infusion catheter assembly
configured to move within the evacuation lumen.
[0043] According to another aspect of the invention, a method of
treating a blood vessel comprises advancing an evacuation sheath
assembly into the blood vessel, creating a first seal between the
blood vessel and the evacuation sheath assembly, advancing an
interventional device across a stenosis to be treated, treating the
stenosis, inducing retrograde flow at the stenosis, establishing a
second seal between the blood vessel and the interventional device,
releasing the first seal to permit antegrade blood flow toward the
treatment site, and applying suction to carry embolic material
dislodged during treating and the antegrade blood flow into the
evacuation sheath assembly.
[0044] Additional objects and advantages of the invention will be
set forth in part in the description which follows, and in part
will be obvious from the description, or may be learned by practice
of the invention. The objects and advantages of the invention will
be realized and attained by means of the elements and combinations
particularly pointed out in the appended claims.
[0045] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the invention, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate several
embodiments of the invention and together with the description,
serve to explain the principles of the invention. In the
drawings,
[0047] FIG. 1A is a cross-sectional side view of a partial length
evacuation sheath according to one embodiment of the present
invention;
[0048] FIG. 1B is a cross-sectional view of the partial length
evacuation sheath taken along line 1B-1B of FIG. 1A;
[0049] FIG. 1C is a cross-sectional side view of an alternative
embodiment of a partial length evacuation sheath according to one
embodiment of the present invention;
[0050] FIG. 1D is a cross-sectional view of the partial length
evacuation sheath taken along line 1D-1D of FIG. 1C;
[0051] FIG. 2A is a cross-sectional side view of an expandable
evacuation sheath, shown in an unexpanded state, according to
another embodiment of the present invention;
[0052] FIG. 2B is a cross-sectional view of the unexpanded
expandable evacuation sheath taken along line 2B-2B of FIG. 2A;
[0053] FIG. 2C is a cross-sectional side view of the expandable
evacuation sheath of FIG. 2A in an expanded state;
[0054] FIG. 2D is a cross-sectional view of the expanded expandable
evacuation sheath taken along line 2D-2D of FIG. 2C;
[0055] FIG. 2E is a cross-sectional view of the expanded evacuation
sheath taken a long line 2E-2E of FIG. 2C.
[0056] FIG. 3A is cross-sectional side view of a full-length
evacuation sheath according to another embodiment of the present
invention;
[0057] FIG. 3B is cross-sectional view of the full-length
evacuation sheath taken along line 3B-3B of FIG. 3A;
[0058] FIG. 4A is cross-sectional side view of a guiding
catheter/evacuation sheath combination according to yet another
embodiment of the present invention;
[0059] FIG. 4B is cross-sectional view of the guiding
catheter/evacuation sheath combination taken along line 4B-4B of
FIG. 4A;
[0060] FIG. 5A is cross-sectional view of the partial evacuation
sheath of FIGS. 1A and 1B deployed within a vessel;
[0061] FIG. 5B is cross-sectional view of the expandable evacuation
sheath of FIGS. 2A-2D deployed within a vessel;
[0062] FIG. 5C is cross-sectional view of the full-length
evacuation sheath of FIGS. 3A and 3B deployed within a vessel;
[0063] FIG. 5D is cross-sectional view of the guiding
catheter/evacuation sheath combination of FIGS. 4A and 4B deployed
within a vessel;
[0064] FIGS. 6A-6I are cross-sectional views of the partial length
evacuation sheath of FIGS. 1A and 1B as employed in a method
according to one aspect of the present invention;
[0065] FIGS. 7A-7I are cross-sectional views of the expandable
evacuation sheath of FIGS. 2A-2D as employed in a method according
to another aspect of the present invention;
[0066] FIGS. 8A-8I are cross-sectional views of the full-length
evacuation sheath of FIGS. 3A and 3B as employed in a method
according to a further aspect of the present invention;
[0067] FIGS. 9A-9H are cross-sectional views of the guiding
catheter/evacuation sheath of FIGS. 4A and 4B as employed in a
method according to yet another aspect of the present
invention;
[0068] FIG. 10A is a cross-sectional side view of another
embodiment of an evacuation sheath assembly enclosed in a delivery
sheath and being delivered through a guiding catheter;
[0069] FIG. 10B is a cross-sectional side view of a braided sheath
forming an evacuation head of the evacuation sheath assembly of
FIG. 10A in an unexpanded state with the delivery sheath
removed;
[0070] FIG. 10C is a cross-sectional side view of the braided
sheath of FIG. 10B in the expanded state; and
[0071] FIG. 10D is cross-sectional view of the guiding/evacuation
lumen of the evacuation sheath assembly of FIGS. 10A-10C deployed
within a blood vessel.
[0072] FIG. 11A is a cross-sectional side view of a partial length
evacuation sheath according to one embodiment of the present
invention;
[0073] FIG. 11B is a cross-sectional view of the partial length
evacuation sheath taken along line A-A of FIG. 11A;
[0074] FIG. 11C is a cross-sectional side view of a partial length
evacuation sheath according to one embodiment of the present
invention;
[0075] FIG. 11D is a cross-sectional view of the partial length
evacuation sheath taken along line A-A of FIG. 11C;
[0076] FIG. 11E is a cross-sectional side view of a partial length
obturator according to one embodiment of the present invention;
[0077] FIG. 11F is a cross-sectional view of the partial length
obturator taken along line A-A of FIG. 11E;
[0078] FIG. 11G is a cross-sectional side view of the partial
length obturator located within a partial length evacuation
sheath;
[0079] FIG. 11H is a cross-sectional side view of partial length
balloon obturator according to one embodiment of the present
invention;
[0080] FIG. 11I is a cross-sectional view of the partial length
balloon obturator taken along line A-A of FIG. 11H;
[0081] FIG. 11J is a cross-sectional view of the partial length
balloon obturator taken along line B-B of FIG. 11H;
[0082] FIG. 11K is a cross-sectional side view of the partial
length balloon obturator located within a partial length evacuation
sheath;
[0083] FIG. 12A is a cross-sectional side view of an infusion
catheter according to one embodiment of the present invention;
[0084] FIG. 12B is a cross-sectional view of the infusion catheter
taken along line A-A of FIG. 12A;
[0085] FIG. 12C is a cross-sectional view of the infusion catheter
taken along line B-B of FIG. 12A;
[0086] FIG. 12D is a cross-sectional side view of an infusion
catheter according to one embodiment of the present invention;
[0087] FIG. 12E is a cross-sectional view of the infusion catheter
taken along line A-A of FIG. 12D;
[0088] FIG. 12F is a cross-sectional view of the infusion catheter
taken along line B-B of FIG. 12D;
[0089] FIG. 12G is a cross-sectional side view of an alternative
infusion catheter according to one embodiment of the present
invention;
[0090] FIG. 12H is a cross-sectional view of the infusion catheter
taken along line A-A of FIG. 12G;
[0091] FIG. 12I is a cross-sectional side view of another infusion
catheter according to one embodiment of the present invention;
[0092] FIG. 12J is a cross-sectional view of the infusion catheter
taken along line A-A of FIG. 12I;
[0093] FIG. 12K is a cross-sectional side view of an infusion
catheter according to one embodiment of the present invention;
[0094] FIG. 12L is a cross-sectional view of the infusion catheter
taken along line A-A of FIG. 12K;
[0095] FIG. 12M is a cross-sectional side view of an infusion
catheter according to one embodiment of the present invention;
[0096] FIG. 12N is a cross-sectional view of the infusion catheter
taken along line A-A of FIG. 12M;
[0097] FIG. 13 is a cross-sectional view of the partial length
evacuation sheath of FIGS. 11A and 11B deployed in a blood vessel
according to a further aspect of the present invention;
[0098] FIG. 14 is a cross-sectional view of the partial length
evacuation sheath of FIGS. 11A and 11B and the over the wire
infusion sheath of FIGS. 12K and 12L deployed in a blood vessel
according to a further aspect of the present invention; and
[0099] FIG. 15 is a cross-sectional view of a heart with a coronary
sinus partially occluded by an occlusion catheter according to one
aspect of the present invention.
DESCRIPTION OF THE EMBODIMENTS
[0100] Reference will now be made in detail to the present
embodiments of the invention, examples of which are illustrated in
the accompanying drawings. Wherever possible, the same reference
numbers will be used throughout the drawings to refer to the same
or like parts.
[0101] The present invention provides a system and method for
evacuating emboli, particulate matter, and other debris from a
blood vessel, and particularly from an occluded blood vessel. As
used herein, an "occlusion," "blockage," or "stenosis" refers to
both complete and partial blockages of the vessels, stenoses,
emboli, thrombi, plaque, debris and any other particulate matter
which at least partially occludes the lumen of the blood
vessel.
[0102] Additionally, as used herein, "proximal" refers to the
portion of the apparatus closest to the end which remains outside
the patient's body, and "distal" refers to the portion closest to
the end inserted into the patient's body.
[0103] This method and apparatus are particularly suited to be used
in diseased blood vessels that have particularly fragile lesions,
or vessels whereby the consequences of even small numbers of small
emboli may be clinically significant. Such blood vessels include
diseased SVGs, carotid arteries, coronary arteries with thrombus,
and renal arteries. However, it is contemplated that the method and
apparatus can be adapted to be used in other areas, such as other
blood vessels.
[0104] As embodied herein and shown in FIG. 1A, an evacuation
sheath assembly 100 is provided. Evacuation sheath assembly 100
includes an evacuation head and a shaft. As embodied herein and
shown in FIG. 5A, the evacuation sheath assembly 100 is sized to
fit inside a guide catheter to advance a distal end of the
evacuation sheath assembly into a blood vessel to treat a
stenosis.
[0105] Although described herein with respect to coronary artery
intervention, it is contemplated that evacuation sheath assembly
100 may be suitable for use in other surgical procedures in other
vessels, where reduction or removal of a blockage in a blood vessel
is beneficial. Additionally, although the method of use of the
evacuation sheath assembly will be described with respect to
placing a stent within a vessel, the evacuation sheath assembly 100
can be used during other therapies, such as angioplasty,
atherectomy, thrombectomy, drug delivery, radiation, and diagnostic
procedures.
[0106] As shown in FIG. 1A, an evacuation head 132 is provided.
Evacuation head 132 includes a multi-lumen tube 138. The
multi-lumen tube 138 is preferably made of a relatively flexible
polymer such as low-density polyethylene, polyurethane, or low
durometer Pebax.RTM. material. Alternatively, the multi-lumen tube
138 can be made of a composite polymer and metal material or from
other suitable biocompatible materials exhibiting appropriate
flexibility, for example. The multi-lumen tube 138 preferably
includes first and second lumens. The first and preferably larger
of the lumens, an evacuation lumen 140, is designed to allow for
the passage of interventional devices such as, but not limited to,
stent delivery systems and angioplasty catheters. The evacuation
lumen 140 is also designed to allow for fluid flow, such as blood,
blood/solid mixtures, radiographic dye and saline, within the
evacuation lumen 140. This flow of fluid may occur regardless of
whether an interventional device is within the evacuation lumen
140. The proximal and distal ends 140a, 140b of the evacuation
lumen 140 are preferably angled to allow for smoother passage of
the evacuation sheath assembly 100 through a guide catheter, and
into a blood vessel, and to facilitate smoother passage of other
therapeutic devices through the evacuation lumen 140 of the
evacuation head 132. The larger area of the angled open ends also
allows for larger deformable particulate matter to pass through the
lumen more smoothly.
[0107] The second and preferably smaller lumen of the multi-lumen
tube 138 is an inflation lumen 142 (having an open proximal end
142a and a closed distal end 142b) designed to provide fluid to
inflate balloons on the evacuation head 132. The fluid may be
either gas or liquid in form.
[0108] An alternative construction of the multi-lumen tube 138 of
the evacuation head 132 is shown in FIG. 1C. Depending on the
tortuosity of the curves of the guide catheter and the blood vessel
through which the evacuation head 132 is to be advanced, it may be
desirable to incorporate a kink resisting structure. As embodied
herein and shown in FIG. 1C, the multi-lumen tube 138 may be formed
around a coil 139 such that the coil 139 is embedded within the
multi-lumen tube 138. Alternatively, coil 139 may be positioned on
the inside surface defining the evacuation lumen 140. The coil 139
can be "wound-down" initially, then re-expanded to make contact
with the inner surface of evacuation lumen 140. A covering of
polyurethane can then be applied to contain the coil 139, and
secure it in position within evacuation lumen 140. The polyurethane
may be applied by a solvent casting of polyurethane in an
appropriate solvent. Alternatively, the structure may be formed by
coextruding the shaft tube together with a coil or braid or by
other suitable means. A further alternative may include positioning
the coil on the outer surface of the multi-lumen tube 138.
[0109] An alternative construction of the multi-lumen tube 138 of
the evacuation head 132 is shown in FIG. 11A and incorporates a
kink-resisting structure. A coil 139 can be wound directly onto the
multi-lumen tube or expanded from a wound state and slidingly
placed over the multi-lumen tube. The proximal and distal ends of
coil 139 are wound at a reduced pitch to allow the final coil to be
positioned adjacent to the marker bands 146a and 146b. This
produces a gradual stiffness transition to prevent kinking at the
interface between the coil 139 and the marker bands 146a and 146b.
A covering of polyurethane 133 is then applied to contain the coil
139, and secure it in position over the multi-lumen tube of
evacuation head 132. The polyurethane may be applied by a solvent
casting of polyurethane in an appropriate solvent. Alternatively,
in a currently preferred method, the structure may be formed by
applying a coating of UV curable polyurethane between
multi-lumen/coil structure and a removable Teflon.RTM. sleeve. The
combination is then exposed to UV light and cured. The Teflon
sleeve is then removed from the structure leaving a smooth coating
surface 133 that encapsulates the coil 139.
[0110] The evacuation head 132 also contains a flare 131 on the
proximal end 140a of the evacuation lumen 140. This flare 131 is
intended to allow for easier passage of devices through the
proximal end 140a of the evacuation lumen 140. The flare 131 can
also create a clearance seal that prevents the passage of fluid
between the evacuation head 132 and the guide catheter 160. This
provides a sliding seal when the proximal and distal sealing
balloons 134 and 136 are deflated.
[0111] Additionally, the evacuation lumen 140 has a distal end 140b
that is angled. The angled distal end allows for the distal end
140b to be more flexible than the portion of the evacuation head
132 that is proximal to it. This is intended to reduce the trauma
induced into the vessel during delivery of the evacuation head 132.
Preferably, The distance from the end of the balloon 136 and the
distal end of the evacuation lumen 140b is minimized to reduce a
chance of the evacuation lumen distal end 140b from coming in
contact with the vessel wall while the distal sealing balloon 136
is inflated. This is intended to prevent the obstruction of flow
through the evacuation lumen 140. FIG. 11B is a cross-sectional
view of the assembly shown in FIG. 11A.
[0112] FIG. 11C is an alternative embodiment of an evacuation
sheath assembly according to the present invention. This embodiment
is similar to that described in connection with FIGS. 11A and 11B,
except that the distal tip of the evacuation head 132 is cut
perpendicular to the axis of the evacuation lumen 140 and proximate
to the distal sealing balloon 136. The perpendicular cut is useful
when the anatomy is such that an angled distal end would contact
the vessel wall in a way which limits fluid flow through evacuation
lumen 140. FIG. 11D is a cross-sectional view of the assembly shown
in FIG. 11C.
[0113] The evacuation sheath assemblies previously described may
encounter difficulty in traversing tortuous anatomy due to their
relatively large diameter. FIG. 11E shows an obturator assembly 900
that is designed to be used with the previously described
evacuation sheath assembly 100, or with other sheath assemblies
described later herein, particularly those with respect to FIGS.
1A, 1C, and 3A. Use of the evacuation sheath assembly 100 with
obturator assembly 900 is illustrated in FIG. 11G. The obturator
assembly 900, when placed within the evacuation sheath assembly
100, provides a tip 920 of obturator assembly 900 which extends
beyond the evacuation sheath assembly 100. The tip 920 is
preferably less stiff and smaller in diameter than the evacuation
sheath assembly 100, and provides a gradual diameter and stiffness
transition to the larger evacuation sheath assembly 100. This
design allows the operator to traverse tortuous anatomy more easily
than without the obturator assembly 900. The tip 920 may also be
formable to allow the operator to bend the tip 920 for steering in
blood vessels. The operator directs tip 920 by applying a torque to
the proximal end 900a of the obturator assembly 900.
[0114] The obturator assembly 900 is preferably made of a polymer
or polymer-metal composite material, but other biocompatible
materials having suitable flexibility characteristics may be used.
As shown, only a distal portion 900b has an enlarged diameter.
Alternatively, the entire length of obturator assembly 900 could
have a uniform diameter. The diameter of the enlarged distal
portion 900b is relatively close to an inside dimension of the
evaluation lumen 140 of evacuation sheath assembly 100. The
obturator assembly 900 has a guide wire lumen 930 with a proximal
end 930a and a distal end 930b. The proximal end 930a of guide wire
lumen 930 is preferably located distally of the proximal end 900a
of the obturator assembly 900. The guide wire lumen 930 is designed
to allow for the passage of a guide wire. A fluid source (not
shown) may be connected to a luer fitting 940. An infusion lumen
910 allows for the flow of fluid from a fluid source through a
proximal end 910a to a distal end 910b of the lumen 910. Fluids may
include radiopaque dye, heparin/saline mixture, or blood. A
radiopaque marker band 950 is located at the end of tip 920 to
allow the operator to visualize the tip of the obturator assembly
900 during angiography. FIG. 11F is a cross-sectional view of the
obturator assembly 900 shown in FIG. 11E.
[0115] Alternatively, the obturator assembly may be constructed as
a balloon catheter. FIG. 11H illustrates an embodiment of a balloon
obturator assembly 1000. The balloon obturator assembly 1000 has a
catheter shaft 1015 that is preferably made of a polymer or a
polymer metal composite, or other biocompatible material having
suitable flexibility characteristics. The catheter shaft 1015
includes proximal and distal shaft portions 1015a and 1015b,
respectively.
[0116] The balloon obturator assembly 1000 includes a guide wire
lumen 1030 for passing a guide wire through. The guide wire lumen
1030 has a proximal end 1030a and a distal end 1030b. Proximal end
1030a is preferably located distally of the proximal end 1000a of
the balloon obturator assembly 1000. The balloon obturator assembly
1000 also includes an inflation lumen 1070, which allows fluid flow
between a fluid source (not shown) connected to a luer fitting 1060
and a balloon 1090. The fluid passes through an inflation port 1080
to inflate balloon 1090.
[0117] The balloon obturator assembly 1000 may also include an
infusion lumen 1040. A proximal end 1040a of infusion lumen 1040
has a sealed connection to a luer fitting 1045. Luer fitting 1045
may be connected to a fluid source (not shown). The fluid source
contains a fluid such as radiopaque dye, heparin/saline mixture, or
blood. The infusion lumen 1040 allows for fluid flow between the
fluid source and the distal end 1040b of the infusion lumen 1040,
where the fluid exits the infusion lumen 1040 through infusion
port(s) 1050. A radiopaque marker band 1010 is preferably attached
to distal tip 1000b of the balloon obturator assembly 1000. This
allows the operator to visualize the location of the balloon
obturator assembly 1000 during angiographic procedures. FIG. 11I
and FIG. 11J are cross-sectional views of the balloon obturator
assembly FIG. 11H taken along lines A-A and B-B, respectively.
[0118] FIG. 11K shows the balloon obturator assembly 1000
positioned in a previously described evacuation sheath assembly 100
as it would be used in the blood vessel 150. The balloon 1090 is
inflated against the evacuation lumen 140 to secure the balloon
obturator assembly 1000 to the evacuation sheath assembly 100
during use. In this position, the balloon obturator assembly 1000
provides a gradual diameter transition from the distal guide wire
lumen 1030b, to the distal end of the evacuation sheath assembly
100. The balloon obturator assembly 1000 is designed to be deflated
and removed from the blood vessel 150 after the evacuation sheath
assembly 100 has been properly located in the blood vessel.
[0119] Additionally, the balloon obturator assembly 1000 may be
advanced distal to the evacuation sheath assembly 100 to a
treatment site. The balloon 1090 of the balloon obturator assembly
1000 may then be inflated to pre-dilate the treatment site.
Pre-dilatation will allow subsequent treatment devices to traverse
the treatment site more easily. Additionally, the balloon obturator
assembly 1000 can provide infusion fluids to a location distal of
the treatment site through the infusion port(s) 1050. The infusion
of fluid can be done with the balloon 1090 inflated or deflated.
The infusion of fluids provides fluids distal to the treatment site
and also provides a fluid for particulate removal, as will be
described later in conjunction with other embodiments of infusion
catheters.
[0120] According to one aspect of the invention, the evacuation
head 132 includes at least one expandable sealing surface. As
embodied herein and shown in FIG. 1A, two expandable sealing
surfaces are provided. A first proximal sealing surface is
configured to form a seal within the guide catheter which delivers
the evacuation sheath assembly 100 to the surgical site, as will be
described. First proximal sealing surface is preferably a proximal
sealing balloon 134. A second distal sealing surface is configured
to form a seal within the blood vessel, as also will be described.
Second distal sealing surface is preferably a distal sealing
balloon 136. As shown in FIG. 1A, it is preferable that the distal
sealing balloon 136 be larger in size than the proximal sealing
balloon 134. The proximal balloon 134 and the distal balloon 136
are in fluid communication with the inflation lumen 142 of
evacuation head 132. Inflation lumen 142 is in fluid communication
with a balloon inflation device 199 (see FIG. 5A). Although only a
single inflation lumen 142 is shown, it is possible to use more
than one inflation lumen. In such an embodiment, the multi-lumen
tube 138 would comprise three lumens, two inflation lumens, each
one in fluid communication with one of the sealing balloons 134,
136, and one evacuation lumen. Each lumen would be in fluid
communication with its own lumen extending proximally to an
inflation device (not shown).
[0121] Preferably, the proximal and distal balloons 134, 136 are
formed of an elastomer such as polyurethane or silicone. It is
preferable to utilize elastomeric balloons, particularly for the
distal sealing balloon 136, to allow the balloon to have a range of
inflated diameters, depending on the volume of fluid infused into
the balloon. Each sealing balloon 134, 136 includes two waist
portions, one proximal 134a, 136a and one distal 134b, 136b of a
body portion of the balloon. The waists portions 134a, 134b, 136a,
136b are preferably secured to an exterior of the multi-lumen tube
138 using heat welding, solvent bonding, or other suitable adhesive
bonding techniques.
[0122] Although use of separate proximal and distal sealing
balloons 134, 136 is preferred, it is possible to instead use a
single elastomeric tube extending nearly the full length of the
multi-lumen tube 138. The single elastomeric tube would be secured
to the outside of the multi-lumen tube 138 at the distal and
proximal ends 140b, 140a of evacuation lumen 140, as well as in the
middle region of the evacuation lumen 140. In this manner, two
expandable sealing surfaces are provided by the two regions of the
single elastomeric tube which are not secured to the exterior of
the shaft tube, i.e., the region between the proximal end 140a and
the middle region would form a proximal sealing surface, and the
region between the distal end 140b and the middle region would form
a distal sealing surface.
[0123] As embodied herein, the balloons 134, 136 may be blow molded
from tubing or dip molded to approximate the shape and minimum
anticipated diameter of their final inflated condition.
Particularly for the distal sealing balloon 136, further inflation
would further increase the diameter, as the balloon is preferably
elastomeric. Alternatively, however, the balloons need not be
pre-molded to the expanded shape. In such a variation, each balloon
134, 136 is preferably a uniform diameter tube between the two
balloon waists 134a, 134b, 136a, 136b. As the uniform diameter
tubes are preferably elastomeric materials, they can be elastically
expanded to the same shape and size as the alternative pre-molded
balloons. The non-pre-molded balloons would require a higher
inflation pressure to expand to a particular dimension.
Furthermore, the non-pre-molded elastomeric balloons would deflate
more easily, as the elasticity would help to force the inflation
fluid from the interior of the balloons. To improve the range of
expandability of the elastomeric balloons, it is preferable for the
body portion of each balloon 134, 136 to have a length at least as
great as the maximum inflated diameter, and more preferably several
times longer, for example about 3-4 times longer.
[0124] While it is preferred to provide the two expandable sealing
surfaces of two elastomeric balloons 134, 136, as described above,
it is possible to fabricate the proximal sealing balloon 134 of a
non-elastomeric polymer molded to the shape and size as shown in
FIG. 1A. Since the proximal balloon 134 is intended to be inflated
within the guide catheter, it is only necessary for the proximal
balloon 134 to be inflated against the internal diameter of the
guide catheter. The distal sealing balloon 136, however, preferably
has a relatively wide range of expanded diameters, and therefore
benefits from being elastomeric. Additionally, if the distal
sealing balloon 136 is elastomeric, and the proximal sealing
balloon 134 is fabricated of a pre-molded thin-walled polymer such
as PET or nylon, and if both balloons are inflated from a common
inflation lumen 142, then the proximal sealing balloon 134 will
expand against the internal surface of the guide catheter, causing
a seal, prior to any significant expansion of the distal sealing
balloon 136 beyond its initial dimension.
[0125] As discussed earlier, the evacuation sheath assembly 100 is
configured to be used with a guiding catheter 160 (see FIGS. 5A and
6A). The guiding catheter 160 performs an evacuation function in
combination with the evacuation lumen 140. The guiding catheter 160
also maintains a contrast delivery function. The evacuation head
132, with its two sealing balloons 134, 136 inflated, is intended
to isolate fluid communication of the internal lumen of the guide
catheter 160 to the blood vessel 150 in which it is inserted.
Preferably, proximal and distal radiopaque markers 146a, 146b are
placed at the site of each balloon 134, 136. Alternatively, two
markers may be placed proximally and distally adjacent to each
balloon 134, 136. The proximal and distal radiopaque markers 146a,
146b allow the operator to radiographically position the two
sealing balloons 134, 136 in the proper location within the guiding
catheter 160 and the blood vessel 150.
[0126] In use, the distal balloon 136 is intended to be positioned
distal of the distal tip of a guiding catheter 160 and inflated
against the inside surface of the blood vessel 150 causing a fluid
tight seal between the blood vessel 150 and the balloon 136. The
proximal balloon 134 is intended to be positioned proximal of the
distal end of the guiding catheter 160 and inflated against the
guiding catheter 160 causing a fluid tight seal.
[0127] The preferred inflated diameters of the sealing balloons
134, 136 are thus determined by the intended application. For
example, if the evacuation sheath assembly 100 is intended to be
used in a diseased saphenous vein bypass graft, (SVG), a guiding
catheter of 8 French may be utilized. The proximal sealing balloon
134 will therefore require an inflated diameter capable of sealing
against the inside of the guiding catheter, typically in the range
of about 0.088-0.096 inches. The distal sealing balloon 136 will
need to be capable of sealing against the inside of the SVG, which
typically has an inside diameter ranging from about 2.5-6 mm.
[0128] The length of the evacuation head 132 is dependent on the
application for which the evacuation sheath assembly 100 is
intended to be used. It is intended that the evacuation head 132 be
long enough for the proximal sealing balloon 134 to be sealingly
inflated within the guide catheter 160, and the distal sealing
balloon 136 to be sealingly inflated within the blood vessel of
interest. In many applications, therefore, evacuation head 132 can
be relatively short. For example, in the case of an SVG
application, this length may be on the order of 2 to 5 cm. However,
in a native coronary artery application, particularly in the left
coronary circulation, it may be desired to have the evacuation head
132 longer, such that the distal sealing balloon 136 is positioned
beyond the first or other main bifurcation. For example, it may be
desired to position the distal sealing balloon 136 within the left
anterior descending artery, distal of the left main artery. For
this application, the evacuation head 132 is preferably about 5 to
about 20 cm in length.
[0129] The diameter of the evacuation head 132 is also dependent on
the intended application. As an example, preferred dimensions are
described here with respect to an application in SVGs, with use of
an 8 French guide catheter whose inner diameter is about 0.090
inches. The evacuation lumen 140 may be approximately 0.061 inches,
which will allow the passage of most therapeutic devices such as
angioplasty catheters, stent delivery catheters, atherectomy
catheters, drug delivery catheters, etc. The inflation lumen 142
may have a dimension of about 0.005 inches at the widest portion of
the crescent (vertical direction in FIG. 1B). The wall thickness
for most of the multi-lumen tube wall 138 may be about 0.002
inches, and the balloon waist thickness may be approximately 0.002
inches. These dimensions create an evacuation head 132 having a
maximum diameter (in delivery condition) of about 0.076 inches,
less than the inner diameter of the guide catheter 160.
[0130] According to another aspect of the invention, the evacuation
sheath assembly 100 includes a shaft. As embodied herein and shown
in FIG. 1A, the shaft includes a proximal shaft portion 110, an
intermediate shaft portion 120, and a distal shaft portion 130 (not
shown in FIG. 1A, shaft portion 130 includes evacuation head
132).
[0131] Proximal shaft portion 110 forms a hollow tube. Preferably,
proximal shaft portion 110 is made of stainless steel, however,
other structures and materials, such as polymer and metallic
composites, (e.g., braid reinforced polymer tubes), nickel-titanium
alloy, or other suitable materials exhibiting appropriate
biocompatibility and flexibility properties may be used. The
proximal shaft portion 110 provides fluid communication between an
inflation apparatus (not shown) and the intermediate and distal
shaft portions 120, 130. The proximal shaft portion 110 may also be
coated with a polymer sleeve or spray coating for lubricity.
[0132] Preferably, the proximal shaft portion 110 includes markers
115 on its exterior surface. These markers 115 are positioned to
indicate to a user that the evacuation sheath assembly 100 has been
advanced through the guiding catheter 160 to a location where the
distal end of the evacuation sheath assembly 100 is just proximal
to the distal end of the guiding catheter 160. The proximal shaft
portion 110 is preferably secured to a luer hub 105, for example by
an overlapping weld or adhesive bond joint. The luer hub 105 allows
the evacuation sheath assembly 100 to be connected to an inflation
apparatus for the inflation of the sealing balloons 134, 136. Any
suitable inflation device may be used, including those resident in
hospital cath labs.
[0133] An intermediate shaft portion 120 is secured to the proximal
and distal shaft portions 110, 130, preferably by an overlapping
weld or bond joint. Intermediate shaft portion 120 forms a hollow
tube. Intermediate shaft portion 120 is preferably formed of
polyethylene or Pebax, however, other polymers and polymer metallic
composites, such as polyimide with an incorporated braid of
stainless steel wire, or other suitable material exhibiting
appropriate biocompatibility and flexibility characteristics, may
be used. The intermediate shaft portion 120 provides fluid
communication between the proximal shaft portion 110 and the distal
shaft portion 130. The intermediate shaft portion 120 also
transmits longitudinal force from the proximal shaft portion 110 to
the distal shaft portion 130. The intermediate shaft portion 120 is
preferably more flexible than the proximal shaft portion 110, to
allow navigation of the curves within the distal region of the
guiding catheter, as are often present, particularly in cardiac
related applications.
[0134] A distal end of the intermediate shaft portion 120 is
connected to a distal shaft portion 130, preferably by welding or
bonding. Distal shaft portion 130 includes the inflation lumen 142
of multi-lumen tube 138 and a soft distal tip portion 144. As shown
in FIG. 1A, the inflation lumen 142 is in fluid communication with
the proximal shaft portion 110 and intermediate shaft portion 120.
The distal end of inflation lumen 142 ends in a solid portion
forming the distal end of the distal shaft portion 130. The distal
end of the distal shaft portion 130 is tapered to form soft tip
144. The soft tip 144 may comprise a more flexible polymer secured
to the distal end of the multi-lumen tube 138 of the evacuation
head 132. For example, if the multi-lumen tube 138 is fabricated of
high density polyethylene, the soft tip 144 may be fabricated of a
low durometer polyurethane or Pebax. The soft tip 144 allows the
evacuation sheath assembly 100 to be placed atraumatically into the
blood vessel, even if the blood vessel exhibits tortuosity.
[0135] The shaft of the evacuation sheath assembly preferably
includes a stiffness transition member 135. Stiffness transition
member 135 is attached to the distal end of the proximal shaft
portion 110, for example by welding or bonding. The stiffness
transition member 135 is preferably made of stainless steel, but
other metals such as nickel titanium alloy or polymers may be used.
The stiffness transition member 135 is located co-axially in the
inflation lumen 142 (as shown in FIG. 1B) and extends from the
proximal shaft portion 110 to the soft tip 144. A distal end 137 of
the stiffness transition member 135 preferably includes a spring
tip embedded into the material of the soft tip 144. Embedding the
spring tip into the soft tip 144 allows the stiffness transition
member 135 to prevent longitudinal stretching or compressing of the
evacuation sheath assembly 100.
[0136] Alternatively, the distal end 137 of the stiffness
transition member 135 can have a enlarged welded ball or other
shape which can serve to mechanically interlock the stiffness
transition member 135 within the soft tip 144. The portion of the
stiffness transition member 135 within the tip 144 of the
evacuation sheath assembly 100 also serves to allow the tip to be
formed in a "J-bend", similar to that for coronary guide wires. The
stiffness transition member 135 can then transfer rotational forces
and motion imparted from the proximal region of the evacuation
sheath assembly 100 to the tip 144, to facilitate steering and
navigation of the evacuation head 132 to a desired site in the
blood vessel.
[0137] The stiffness transition member's bending stiffness
decreases gradually from the proximal end to the distal end of the
stiffness transition member 135. Preferably, this is accomplished
by reducing the cross sectional area of the member 135 as shown in
FIG. 1A, where stiffness transition member 135 includes three
portions of decreasing diameter 135a, 135b, 135c from proximal to
distal end. However, this can also be accomplished by changes in
shape and/or materials. The stiffness transition member 135 allows
for a gradual stiffness reduction in the evacuation sheath assembly
100, which allows it to more smoothly navigate the curves of the
guiding catheter and the blood vessel. This shaft construction is
exemplary only, and is not intended to limit the invention.
[0138] As mentioned, although described herein with respect to
stent placement in an SVG or coronary artery having a stenosis,
evacuation sheath assembly 100 may be used in other surgical
procedures and with other therapeutic devices, such as balloon
angioplasty, atherectomy, thrombectomy, drug delivery, radiation,
and diagnostic procedures.
[0139] As embodied herein and shown in simplified drawing FIG. 6A,
the lumen of a blood vessel 150 is accessed with the distal end of
a guiding catheter 160, which is well known in the art and typical
for coronary-type procedures. A coronary guide wire 170 then is
advanced to a location just proximal to the distal tip of the
guiding catheter 160. Blood flow at this point remains in the
direction of normal arterial blood flow. The blood is flowing
around and past the distal tip of the guiding catheter 160 and
through the stenosis 180 as indicated by arrows 190.
[0140] As shown in FIG. 6B, the evacuation sheath assembly 100 then
is advanced over the guide wire 170 and positioned within the
vessel 150 with the distal radiopaque marker 146b distal of the
distal tip of the guiding catheter 160 (i.e., within the vessel
150) and the proximal marker 146a proximal of the distal tip of the
guiding catheter 160 (i.e., within catheter 160), as determined
through appropriate imaging techniques known in the art.
Alternatively, the guide catheter 160 may be positioned within the
ostium of the target vessel, and the evacuation sheath assembly 100
may be advanced through the catheter and beyond a major side branch
of the target vessel.
[0141] Blood flow continues to be in the direction of normal
arterial blood flow as shown by arrows 190. Because the assembly
100 has as relatively short evacuation head 132, the entire
evacuation sheath assembly 100 can be advanced over a conventional
length coronary guide wire 170 after the guide wire 170 has been
placed within the guide catheter 160.
[0142] Once the evacuation head 132 is positioned with its distal
end within the vessel 150 while its proximal end remains in the
catheter 160, the distal and proximal sealing balloons 136, 134 are
inflated as shown in FIG. 6C. The distal sealing balloon 136
provides a fluid tight seal between the sealing balloon 136 and the
blood vessel 150 and the proximal sealing balloon 134 provides a
fluid tight seal between the sealing balloon 134 and the interior
diameter of the guiding catheter 160. A suitable valve 184, such as
a touhy borst valve, attached to the guiding catheter 160 (shown in
FIG. 5A) provides a fluid tight seal against the guide wire 170 and
the proximal shaft portion 110 of the evacuation sheath assembly
100. The three fluid tight seals establish fluid communication
between the distal end of the evacuation sheath assembly 100 and a
fluid collection chamber, filter, and vacuum source 188, which is
attached to the Y-adaptor (conventional) 184 shown in FIG. 5A. A
blood pressure transducer 192 is commonly connected in fluid
communication with the lumen of the guide catheter 160 (through
additional stop cocks or manifolds as is well-known in the art) to
monitor arterial blood pressure. As the sealing balloons 134, 136
are inflated to establish the fluid communication of the evacuation
sheath assembly and guide catheter 160 with the collection chamber,
filter, and vacuum source 188, the blood pressure waveform can be
observed to change from a relatively high pressure and pulsatile
waveform of the artery, to a relatively low and constant waveform
of the venous pressure. This pressure observation is an important
indicator that the sealing balloons 134, 136 have effectively
isolated fluid communication to the coronary artery. With the three
fluid tight seals in place, a normal antegrade flow within the
artery is stopped. Thus, there is substantially no blood flow
within the vessel 150, as indicated by the lack of arrows in FIG.
6C.
[0143] At this point, it may be desirable to inject a small amount
of contrast into the blood vessel, via a dye injection apparatus
189 in fluid communication with the guide catheter 160, evacuation
head 132, and blood vessel 150, to aid in navigation of the guide
wire 170 across the stenosis 180. The evacuation lumen 140 of the
evacuation head 132 becomes an extension of the guide catheter
lumen for this contrast delivery. Because normal antegrade blood
flow in the coronary artery has been effectively stopped, the
contrast will remain in the coronary artery, rather than quickly
washing away. This may be advantageous for the subsequent
navigation of the guide wire 170.
[0144] Once antegrade flow is stopped, as shown in FIG. 6C, the
guide wire 170 is advanced across the stenosis 180. In most cases,
to begin advancing the guide wire 170, the touhy borst valve 184 on
the Y-adaptor (shown in FIG. 5A) will need to be opened just enough
to allow for movement of the wire 170, but not so much to allow
vigorous backbleeding. In the procedure described here, it is
preferred to open the valve only enough such that there is little
to no backbleeding, otherwise the venous pressure head in the
coronary artery can cause retrograde flow during this step, thereby
pushing all of the contrast back into the guide catheter and out of
the blood vessel.
[0145] Once the wire has crossed the stenosis 180, it may be
desirable to cause retrograde flow in the coronary artery (FIG.
6D), as the act of crossing a stenosis 180 with a wire 170
(particularly a fragile lesion (stenosis), such as in an SVG) may
in itself dislodge material. Any material dislodged will not travel
downstream, as the antegrade flow has already been stopped.
Retrograde flow can be used to remove the dislodged material.
[0146] With all seals in place, blood flow may now be established
from the distal end of the evacuation head 132 to the collection
chamber, and filter 188 to remove any dislodged material.
Retrograde flow is represented in FIG. 6D by arrows 195. This
retrograde flow is due to the venous pressure head, and will begin
once the pressure in the collection bottle 188 is vented to
atmospheric pressure. Flow can also be increased by applying vacuum
to the collection chamber and filter 188. This retrograde flow will
carry any dislodged material out of the patient and into a
collection chamber. The collection chamber may be a simple syringe
or may be any other suitable container. If a syringe is used,
withdrawal of the plunger automatically causes a vacuum to induce
retrograde flow. After enough volume has been removed, the flow can
be stopped by closing the valve to atmosphere pressure or by
releasing the vacuum. If desired, after any dislodged material has
been removed, the balloons 134, 136 of the evacuation sheath
assembly 100 may be temporarily deflated, allowing for a period of
antegrade blood flow and perfusion of the vessel 150.
[0147] After any dislodged material has been removed, and after
normal antegrade blood flow has been allowed, if so desired, all
seals are again established. With all seals in place, a therapeutic
device such as a stent delivery system 193 is advanced across the
stenosis 180 with antegrade flow stopped, as shown in FIG. 6E. The
touhy borst valve 184 attached to the guide catheter 160, which is
shown in FIG. 5A, seals against the proximal end of the therapeutic
device, the guide wire 170 and the proximal shaft portion 110 of
the evacuation sheath assembly 100. Alternatively, advancement of
the delivery system may be done with retrograde flow. In a step
similar to that for the guide wire advancement, some contrast may
be delivered into the vessel, allowing continuous visualization of
the vessel and stenosis for more precise placement of the stent
delivery catheter 193. Again, to effectively keep the contrast in
place, the touhy borst valve 184 through which the stent delivery
catheter 193 passes must be opened just enough to allow for
advancement of the device with little to no backbleeding.
[0148] Once the stent delivery system 193 is accurately positioned
adjacent the stenosis 180, a stent delivery balloon is inflated to
expand a stent 194 against the vessel wall, opening a passage for
blood flow through the stenosis 180 (FIG. 6F). During inflation of
the stent balloon, retrograde flow (if present) is discontinued by
the occlusion of the blood vessel by the therapeutic device and the
stoppage of any applied vacuum.
[0149] After the stent 194 is applied to the stenosis 180, the
stent delivery balloon is deflated and retrograde flow is
re-established in the vessel 150. Any embolic material 197
dislodged from the therapeutic site is carried back to the
evacuation lumen 140 of the evacuation head 132 by the retrograde
flow 195 (FIG. 6G). The embolic material 197 may include material
dislodged during advancement of the therapeutic device, or during
the expansion of the stent 194, in the case where the therapeutic
device includes a stent 194. To remove this potentially embolic
debris 197, the retrograde flow 195 is re-established when the
therapeutic device is no longer occluding the blood flow, and
additional vacuum is preferably applied to the evacuation lumen
140. The therapeutic device may be left in place while there is
retrograde flow, or it may be positioned proximal to the stenosis
180, or even brought back within the lumen of the guide catheter
160. In some instances, once the particulate 197 has been removed,
additional contrast delivery to the blood vessel may indicate a
need for more therapeutic steps, e.g., further dilation of the
stent with the balloon. In this case, it is more convenient to have
the balloon catheter already in position for any subsequent
use.
[0150] After the embolic material is removed, the therapeutic
device is removed from the vessel 150 (retrograde flow may or may
not be maintained) (FIG. 6H). The distal and proximal sealing
balloons 136, 134 are then deflated (FIG. 6I), establishing normal
arterial flow.
[0151] According to another aspect of the present invention, the
diameter of an evacuation head may be expandable from a first
introduction diameter to a second operational diameter. As embodied
herein and shown in FIGS. 2A-2D, an evacuation sheath assembly 200
is provided with an expandable evacuation head 232. Many of the
elements present in the previous embodiment are also shown in FIGS.
2A-2D and where these elements are substantially the same, similar
reference numerals have been used and no detailed description of
the element has been provided.
[0152] As shown in FIG. 2B, the evacuation head 232 preferably
includes an inner layer 226 that will serve as an evacuation lumen
and an outer layer 228 that will serve as the sealing surfaces.
Preferably, the inner layer 226 is fabricated from polyethylene PET
or Pebax, but other suitable materials may be used. The evacuation
head 232 has a proximal end 232a and a distal end 232b. FIGS. 2A
and 2B show the evacuation head 232 in an unexpanded state and
FIGS. 2C, 2D, and 2E show the evacuation head 232 in an expanded
state. The inner layer 226 of the evacuation head 232 preferably
comprises a tube that unfolds to increase in diameter. In FIG. 2C,
the increase in diameter assumes a step-wise shape. Thus,
preferably, a distal portion of the inner layer 226 of the
evacuation head has an expanded diameter which is larger than a
diameter of a guide catheter 260.
[0153] The expanded shape of the inner layer 226 of the expandable
evacuation head 232 may include a proximal portion having a first
diameter and a distal portion having a second diameter, the second
diameter being larger than the first such that the inner layer 226
of the evacuation head 232 has a larger dimension in the region
which resides within the blood vessel, as shown in FIG. 2C.
Alternatively, the diameters of the proximal and distal portions of
the inner layer 226 of the evacuation head 232 may be the same,
such that the diameter of an expanded inner layer 226 is the same
for the region outside of the guide catheter as the region which
resides within the guide catheter. In such an embodiment, it would
be necessary to provide the distal portion of the evacuation head
232 with a larger or more expansible outer layer, i.e., sealing
surface (distal sealing balloon), to ensure a proper seal with
blood vessel 250.
[0154] The distal and proximal ends of the expanded evacuation head
232 may be angled relative to its longitudinal axis, as discussed
with respect to the embodiment shown in FIG. 1A, although this is
not shown in FIGS. 2A-2D. The low profile folded delivery state of
the evacuation head 232 may not require such angles. Furthermore,
if the distal end of the head 232 is not angled relative to the
longitudinal axis, the entire open distal end of the expandable
evacuation head 232 is suitable for positioning close to the
desired therapy site.
[0155] The outer layer 228 of evacuation head includes multiple
spherical balloons (or balloon regions) 233, including a proximal
most balloon 234 and a distal most balloon 236, with a cylindrical
waist between each balloon. The inner and outer layers 226, 228 of
the evacuation head 232 may be seam welded or bonded together
around the circumference at each waist location, while the inner
layer 226 is in its expanded condition. Prior to insertion of the
evacuation sheath assembly 200 into the guide catheter 260, the
evacuation head 232 is folded into its unexpanded condition, as
shown in FIGS. 2A and 2B. When fluid, either a gas or liquid, is
infused between the inner and outer layers, the outer layer 228
expands radially. As the outer layer 228 expands into multiple
balloon regions 233, it pulls the inner layer 226 with it, opening
the evacuation lumen 240. Thus, the inner and outer layers expand
together in the radial direction when inflated.
[0156] As discussed with respect to the embodiment shown in FIGS.
1A-1C, the evacuation head 232 comprises a multi-lumen tube 238
having an evacuation lumen 240 and an inflation lumen 242. As in
the embodiment shown in FIGS. 1A-1C, the inflation lumen 242 is in
fluid communication with intermediate and proximal shaft portions
210, 220 and is in fluid communication with the individual balloon
segments 233, 234, 236, such that when fluid is infused into
inflation lumen 242, the evacuation head 232 expands. Further
infusion of fluid into the inflation lumen of the evacuation sheath
assembly will inflate the distal and proximal sealing balloons
until they are appropriately sized to cause effective sealing.
[0157] As described previously, in addition to intermediate
balloons 233, the evacuation head 232 includes a proximal sealing
balloon 234 and a distal sealing balloon 236. The proximal sealing
balloon is configured to seal with an inner diameter of the guide
catheter 260 and the distal sealing balloon is configured to seal
with the inner walls of blood vessel 250. The remaining balloons
233 need only be sized to an inflated diameter sufficient to "pull"
open the inner layer 226 of the expandable evacuation head 232.
Although three intermediate balloons 233 are shown in FIG. 2C, more
or fewer balloons may be provided as appropriate, for example
depending upon the length of the evacuation head to be expanded.
Although intermediate balloons 233 are intended to "pull" open
evacuation lumen 240 of the evacuation head 232, balloons 233 may
also provide addition sealing under certain circumstances, as shown
in FIG. 2C. However, it is less important that the remaining
balloons 233 be elastomeric, as they do not necessarily require a
range of expanded diameters.
[0158] As shown in FIGS. 2A and 2B, prior to insertion into the
guide catheter 260, the evacuation head 232 is folded into a
reduced diameter configuration. As illustrated, this folding may be
in a generally "w" type fold, however other folding configurations
are contemplated, such as "s" folds or "c" folds. It is also
preferable to heat set the folded evacuation head 232 in this
configuration. Because the evacuation head has been heat set in a
folded configuration, once the sealing balloons and remaining
balloons are deflated after a procedure, the evacuation head will
refold toward its pre-expanded configuration.
[0159] The low profile of the evacuation head 232 in its delivery
configuration and the soft tip 244 at the end of evacuation sheath
assembly 200 allow the expandable evacuation sheath assembly 200 to
be passed through smaller and more tortuous lumens and blood
vessels. The expandable evacuation lumen 240 also allows the
evacuation sheath assembly 200 to be sized more closely to the
guiding catheter 260 and larger than the guiding catheter 260 in
the portion that is placed distal of the guiding catheter when it
is in the expanded state. This larger lumen allows for high
evacuation flow rates, and eases the ability for large particles to
be removed from the blood vessel during or subsequent to the
therapeutic procedure, while having a relatively small collapsed
delivery condition.
[0160] In use, the evacuation sheath assembly 200 is deployed in a
similar manner as discussed with respect to evacuation sheath
assembly 100. The steps for using evacuation sheath assembly 200
with a guide catheter 260 in a vessel 250 are sequentially depicted
in FIGS. 7A-7I.
[0161] As shown in FIG. 7A, guide catheter 260 and guide wire 270
are advanced proximate to a blood vessel 250. Subsequently,
evacuation sheath assembly 200, with evacuation lumen 240 in its
delivery configuration, is advanced over the guidewire 270 into
guide catheter 260 and blood vessel 250 (FIG. 7B). Once evacuation
head 232 is properly positioned, as can be verified using proximal
markers 115 and markers 246a, 246b, evacuation head 232 is expanded
(FIG. 7C) until evacuation lumen 240 is open. Fluid continues to be
injected into the balloons until proximal balloon 234 creates a
seal with the lumen of guide catheter 260 and until distal balloon
236 creates a seal with blood vessel 250. After the proper seals
are established, the stenosis 280 is treated and any embolic debris
297 is removed via retrograde flow 295 (FIGS. 7C-7H), as previously
described with respect to FIGS. 6C-6H. After treatment, evacuation
head 232, including proximal and distal sealing balloons 234, 236,
is deflated and then removed from blood vessel 250 (FIG. 7I).
[0162] According to another aspect of the present invention, the
evacuation head may comprise an elongated multi-lumen tube. As
embodied herein and shown in FIGS. 3A and 3B, an evacuation sheath
assembly 300 is provided with an evacuation head 332. Many of the
elements present in the previous embodiments are also shown in
FIGS. 3A and 3B and where these elements are substantially the
same, similar reference numerals have been used and no detailed
description of the element has been provided.
[0163] As shown in FIG. 3A, evacuation head 332 includes a single
elongated multi-lumen tube 338. The size of the tube 338 allows it
to be placed through a guiding catheter 360 and into a blood vessel
370 (see FIG. 5C). The tube may be made from a polymer such as
polyethylene or Pebax.RTM. material or materials described with
respect to FIG. 1A. In addition, the tube 338 may include a coil or
braid, as in FIG. 1C, in all or only portions of the tube. The
multi-lumen tube 338 includes two lumens 340, 342. The larger of
the lumens, the evacuation lumen 340, is designed to allow for the
passage of interventional devices such as, but not limited to stent
delivery systems and angioplasty catheters. The lumen is also
designed to allow for fluid flow, such as blood, blood/solid
mixtures, radiographic dye and saline, within the lumen as
discussed with respect to FIGS. 1A-1C.
[0164] A distal end of the tube 338 is tapered into a soft tip 344,
as described in connection with previous embodiments. The soft tip
344 allows the evacuation sheath assembly 300 to be placed more
smoothly into the blood vessel. The tube 338 includes inflation
lumen 342, which allows for fluid communication between the
proximal end of the evacuation sheath assembly 300 and an
expandable sealing surface. The elongated multi-lumen tube 338
defines the entire evacuation lumen 340, unlike the devices shown
in FIGS. 1A-2D which make use of a significant length of the lumen
of the guide catheter for evacuation. For this reason, only a
single expandable sealing surface is required.
[0165] The expandable sealing surface is preferably a distal
sealing balloon 336. Distal sealing balloon 336 may comprise an
elastomeric material such as polyurethane or silicone. The distal
sealing balloon 336 is configured be positioned distal of the
distal tip of a guiding catheter 360 and inflated against the blood
vessel 350 causing a fluid tight seal between the blood vessel 350
and the balloon 336. Radiopaque marker 346 is preferably placed at
the site of the sealing balloon 336. The radiopaque marker 346
allows the operator to radiographically position the sealing
balloon 336 in the proper location within the blood vessel 350. A
proximal shaft portion 310 of the evacuation sheath assembly 300 is
sealed against a valve 384, such as a touhy borst valve, on the
guide catheter 360 creating a fluid tight seal against the
evacuation sheath assembly 300 and the guiding catheter 360.
[0166] The tube 338 includes proximal markers 315 placed on the
exterior of the proximal portion of the tube 338. These markers 315
are positioned to indicate that the tube 338 has been advanced
through the guiding catheter 360 to a location where the distal end
of the evacuation sheath assembly 300 is just proximal to the
distal end of the guiding catheter 360. A proximal portion of the
tube 338 is secured to a bifurcated luer hub 305 by an overlapping
weld or bond joint. The bifurcated luer hub 305 includes an
inflation port 302 and a vacuum port 303 which allows the
evacuation sheath assembly 300 to be connected to an inflation
apparatus and a vacuum source, respectively.
[0167] In use, the evacuation sheath assembly 300 is deployed in a
similar manner to that discussed with respect to evacuation sheath
assembly 100. The steps of using evacuation sheath assembly 300
with a guide catheter 360 in a vessel 350 are sequentially depicted
in FIGS. 8A-8I. The differences between the method discussed with
respect to evacuation sheath assembly 100 and that for evacuation
sheath assembly 300 are discussed below.
[0168] Because the lumen in evacuation sheath assembly 300 runs the
full length of evacuation sheath assembly 300, the evacuation
sheath assembly 300 should be inserted together with the coronary
guide wire 370. Also, because the lumen of the guide catheter 360
is more fully obstructed by this evacuation sheath assembly 300, it
is preferable to inject contrast directly into the proximal end of
the evacuation lumen 340 of the evacuation sheath assembly 300 (or
into both lumen 340 and the lumen of guide catheter 360), rather
than just into the lumen of the catheter 360. Also, both the guide
catheter lumen and the evacuation lumen 340 can be used for
pressure monitoring, although it is more desirable to use the
evacuation lumen 340 for pressure monitoring to confirm a tight
seal between the distal balloon 336 and blood vessel 350 as needed.
As opposed to the earlier discussed embodiments, only one sealing
balloon 336 is used to provide the seal in the evacuation sheath
assembly 300, as shown in FIGS. 8C-8H.
[0169] Thus, as shown in FIG. 8A, guide catheter 360 is positioned
within blood vessel 350. Then evacuation sheath assembly 300 is
advanced with guidewire 370 into blood vessel 350 (FIG. 8B). Proper
positioning of a distal end of evacuation sheath assembly 300 may
be confirmed using distal marker 346. Then distal sealing balloon
336 is inflated via inflation port 302, stopping blood flow within
blood vessel 350. If desired, contrast dye may be injected through
evacuation lumen 340 into blood vessel 350 to view blood vessel 350
prior to treating stenosis 380. Stenosis 380 is then treated and
any embolic debris 397 is removed via retrograde flow 395 through
evacuation lumen 340 (FIGS. 8C-8H), as previously described with
respect to FIGS. 6C-6H. After treatment, distal sealing balloon 336
is deflated and evacuation sheath assembly 300 is removed from
blood vessel 350 (FIG. 8I).
[0170] According to another aspect of the present invention, the
evacuation sheath assembly may comprise an elongated multi-lumen
tube which eliminates the need for a separate guiding catheter. As
embodied herein and shown in FIGS. 4A and 4B, an evacuation/guiding
sheath assembly 400 is provided with an evacuation/guiding lumen
440. Many of the elements present in the previous embodiments are
also shown in FIGS. 4A and 4B and where these elements are
substantially the same, similar reference numerals have been used
and no detailed description of the element has been provided.
[0171] As shown in FIG. 4A, evacuation/guiding sheath assembly 400
includes a single elongated multi-lumen tube 438. The size of the
tube 438 allows it to be used as a combination guiding catheter and
evacuation lumen, to deliver interventional devices into a blood
vessel 450. The multi-lumen tube 438 is preferably formed of a
Pebax.RTM., stainless steel and Teflon.RTM. composite material,
very similar to conventional guide catheters, well known in the
art, with the exception that an additional lumen in the wall of the
tube is provided. Tube 438 can be made of other suitable polymers
and metal materials. The multi-lumen tube 438 includes first and
second lumens. The larger of the lumens, the evacuation/guiding
lumen 440, is designed to allow for the passage of interventional
devices such as, but not limited to, stent delivery systems and
angioplasty catheters. The lumen 440 is also designed to allow for
fluid flow, such as blood, blood/solid mixtures, radiographic dye
and saline, within the lumen. This flow of fluid is allowed with or
without an interventional device in the evacuation/guiding lumen
440.
[0172] The tube 438 can be pre-formed in various curvatures during
manufacturing to allow for easy access to the ostium of several
different blood vessels in a manner similar to conventional guide
catheters as known in the art. Note that FIGS. 4A and 4B do not
show these pre-formed curves. The distal end of the tube 438 is
preferably fitted with a more flexible material, forming a soft
distal tip 444. This flexible tip 444 allows the evacuation/guiding
lumen 440 to be placed more smoothly into the blood vessel. The
tube 438 also contains an inflation lumen 442, which allows for
fluid communication between a proximal end of the
evacuation/guiding sheath assembly 400 and an expandable sealing
surface on a distal end of the evacuation/guiding sheath assembly
400.
[0173] Preferably, the expandable sealing surface is an inflatable
sealing balloon 436. The sealing balloon 436 is preferably
elastomeric and may comprise polyurethane or silicone, similar to
that of the distal sealing balloon of FIGS. 1A-1C. The sealing
balloon 436 is intended to be positioned distal of the ostium of
the blood vessel 450 and inflated against the blood vessel 450
causing a fluid tight seal between the blood vessel 450 and the
balloon 436. Radiopaque markers 446 are preferably placed at the
site of the sealing balloon 436 to allow radiographically verifying
the position of the sealing balloon 436. The proximal portion of
the tube 438 is sealed against a interventional device by a
bifurcated touhy borst valve 484 attached to the evacuation/guiding
sheath assembly 400 to create a fluid tight seal against the
evacuation/guiding sheath assembly 400 and the interventional
device.
[0174] A proximal portion of the tube 338 is secured to the
bifurcated touhy borst luer hub 484 by an overlapping weld or bond
joint. The bifurcated luer hub allows the evacuation sheath
assembly to be connected to an inflation apparatus and a vacuum
source through an inflation port 402 and a vacuum port 403,
respectively.
[0175] The steps of using evacuation/guiding sheath assembly 400
are sequentially depicted in simplified FIGS. 9A to 9H. Use of
evacuation/guiding sheath assembly 400 is similar to the method
described with respect to evacuation sheath assembly 100. The
differences between the method discussed with respect to FIGS.
6A-6I and that for evacuation/guiding sheath assembly 400 are
discussed below.
[0176] The lumen of the blood vessel 450 is accessed with the
distal tip 444 of the evacuation/guiding sheath assembly 400. A
guide wire 470 is advanced to a location just proximal to the
distal tip 444 of the evacuation/guiding sheath assembly 400 (FIG.
9A). Blood flow at this point remains in the direction of normal
arterial blood flow as shown by arrows 490. The evacuation/guiding
sheath assembly 400 is then positioned with the distal marker band
446 distal of the ostium of the blood vessel 450. Once the
positioning of the distal tip 444 of the evacuation/guiding sheath
assembly 400 is verified, the distal sealing balloon 436 is
inflated as shown in FIG. 9B to stop normal antegrade flow. The
distal sealing balloon 436 provides a fluid tight seal between the
sealing balloon 436 and the blood vessel 450. Alternatively, the
distal sealing balloon 436 may be shaped such that it seals against
the aortal surface and the most adjacent portion of the coronary
ostium (not shown).
[0177] A touhy borst valve 484 attached to the evacuation/guiding
sheath assembly 400 (shown in FIG. 5D) provides a fluid tight seal
around the guide wire 470. The two fluid tight seals establish
fluid communication between the distal end of the
evacuation/guiding sheath assembly 400 and a fluid collection
chamber, filter, and vacuum source 488, which is attached to the
bifurcation lumen of the touhy borst valve 484 shown in FIG. 5D,
and stop normal antegrade blood flow within blood vessel 450. A
blood pressure transducer 492 is commonly connected in fluid
communication with the lumen of the guide catheter to monitor
arterial blood pressure.
[0178] If desired, contrast dye may be injected through
evacuation/guiding lumen 440 into blood vessel 450 prior to
treating stenosis 480. Stenosis 480 is then treated and any embolic
debris 497 is removed via retrograde flow 495 through
evacuation/guiding lumen 440 (FIGS. 9C-9G) as previously described
with respect to FIGS. 6C-6H. After treatment, distal sealing
balloon 436 is deflated and evacuation/guiding sheath assembly 400
is removed from blood vessel 450 (FIG. 9H).
[0179] According to another aspect of the present invention, the
diameter of an evacuation head may be expandable from a first
introduction diameter to a second operational diameter. As embodied
herein and shown in FIGS. 10A-10D, an evacuation sheath assembly
500 is provided with an expandable evacuation head 532. Many of the
elements present in the previous embodiment are also shown in FIGS.
10A-10D and where these elements are substantially the same,
similar reference numerals have been used and no detailed
description of the element has been provided.
[0180] The evacuation head 532 of the present embodiment is similar
to the first and second embodiments previously discussed in that
the evacuation sheath assembly 500 comprises a relatively short
evacuation head 532. Evacuation sheath assembly 500 also makes use
of the guide catheter 560 to form a part of an evacuation lumen
540.
[0181] As shown in FIG. 10A, evacuation head 532 includes a tube
538 having a single expandable lumen, evacuation lumen 540.
Evacuation head 532 may have a naturally unexpanded state.
Alternatively, evacuation head 532 may be designed to normally be
in an expanded state. However, it is preferred to have the
evacuation head 532 fabricated to have its natural shape and size
in the reduced dimension, as shown in FIG. 10B.
[0182] The evacuation head 532 includes two sealing surfaces 534,
536. A proximal sealing surface 534 is intended to seal against an
inside distal portion of the guide catheter 560 and a distal
sealing surface is intended to seal against the inside of the blood
vessel 550, for example a coronary artery or an SVG. Although it is
contemplated that the expandable evacuation head 532 could include
two balloon-type seals, for example by adding a sealing balloon to
each end of a tube 538 forming evacuation head 532, it is
preferable to simply allow the outer surface of the expandable
evacuation head 532 to create the sealing surfaces 534, 536.
[0183] Preferably, evacuation tube 538 is formed of a braided
sheath and a coating or covering over the braided sheath. The
braided sheath itself can be made of stainless steel (full hard or
spring), Eligiloy.TM., nickel titanium alloy or other metals or
polymers with high elasticity characteristics. Preferably the
braided sheath which forms tube 538 has a length of between about 3
cm and about 20 cm.
[0184] The braided sheath can be coated with a polymer such as
polyurethane, silicone and other similar elastomeric materials that
can stretch and allow the braided sheath to expand. The covering or
coating is preferably a thin and flexible elastomer, which is dip
coated on the braided sheath. Since the elastomeric covering or
coating is applied to the braided sheath in its reduced dimension,
the covering or coating helps to retain the braided sheath in its
reduced dimension.
[0185] Alternatively, the braided sheath can be fitted with a fluid
tight woven material that has similar expansion qualities as the
braided sheath. If the covering is a braided fabric, it is
preferably made from polyester or other high strength polymer
yarn.
[0186] Alternatively, the covering may be formed of a spun fibers
laid down in multiple layers back and forth along the length of the
braided sheath. If the fiber layers are laid down at the same
helical angle as the primary braided sheath, the covering will
behave similarly to the primary braided sheath upon expansion,
requiring little or no expansile force to expand the covering from
its reduced dimension to its expanded dimension. Each fiber layer
will be made of several adjacent fiber windings to create a dense
layer. Preferably, there are multiple layers, which together will
be relatively impervious to fluid flow, thereby allowing sealing
surfaces of the evacuation head 532 to effectively isolate fluid
communication from the lumen of the guide catheter with the lumen
of the blood vessel.
[0187] The braided sheath is preferably fabricated at its desired
reduced diameter, for example, as utilized in an SVG with an 8
French guide catheter, about 0.4-1.5 mm. The braided sheath is then
coated or covered at this reduced size. The braided sheath which
comprises the evacuation head 532 is preferably connected to an
actuation wire 513 by a few of the filaments near the distal end of
the braided sheath. A proximal hollow shaft 511 is connected to a
few of the braid filaments near a proximal end of the evacuation
head 532 and serves as an anchor point. Actuation wire 513 sits
within the hollow shaft 511 and the braided sheath is preferably
bonded or welded to the proximal hollow shaft 511 at the proximal
end of the braided sheath and to the actuation wire 513 on the
distal end of the braided sheath. The bonds attach in a manner that
does not considerably impede the free movement of the braided
sheath during expansion and contraction.
[0188] The proximal hollow shaft 511 is a tube, which preferably
decreases in stiffness from a proximal end to a distal end thereof.
The proximal hollow shaft 511 can be made of stainless steel
hypotubing, polyethylene, or a composite of polymers and metal.
[0189] Preferably, the evacuation head 532 includes a steerable
spring tip 544 extending from the actuation wire 513. Surrounding a
portion of the spring tip 544 is a nose cone 543. The nose cone 543
serves as a tapering transition between the spring tip 544 and a
distal end of a delivery sheath 547. The nose cone 543 facilitates
smooth advancement of the evacuation sheath assembly through a
guide catheter 560 and into the blood vessel 550.
[0190] The delivery sheath 547 preferably comprises a tube which
covers the entire length of the reduced dimension of the evacuation
head 532. The delivery sheath 547 is connected to a wire shaft (not
shown), which emerges from a proximal end of the guide catheter
560. During evacuation, the delivery sheath 547 may be fully
removed from the lumen of the guide catheter 560, or can be left in
position within the guide catheter 560.
[0191] If the delivery sheath 547 is intended to be removed
completely from the guide catheter 560, it may include a perforated
longitudinal line to allow for splitting of the delivery sheath 547
and removal of the delivery sheath 547 from the proximal hollow
shaft 511 of the evacuation sheath assembly 500.
[0192] Alternatively, if the braided sheath has an expanded natural
shape and size as shown in FIG. 10C, thereby being self-expanding
upon removal of the delivery sheath 547, the delivery sheath 547
would preferably be usable during contracting and removal of the
braided sheath. Thus, the delivery sheath 547 could be re-advanced
to cover and constrain the braided sheath once the procedure is
completed. In this manner, the evacuation sheath assembly 500 could
be removed from the guide catheter 560.
[0193] The proximal end of the evacuation sheath assembly 500 may
have an adjustable lock to anchor the actuation wire 513 to the
proximal hollow shaft 511, allowing them to be held fixed to one
another. This allows the braided sheath to be locked into a set
position.
[0194] The evacuation sheath assembly 500, in use, is depicted in
FIG. 10D. Use of evacuation sheath assembly 500 is similar to the
method described with respect to evacuation sheath assembly 100.
The differences between the method discussed with respect to FIGS.
6A-6I (evacuation sheath assembly 100) and that for evacuation
sheath assembly 500 are discussed below.
[0195] In use, a guide catheter 560 is advanced into blood vessel
lumen 550 over a guidewire 570. Evacuation sheath assembly 500, in
a compressed state having a reduced diameter and enclosed in
delivery sheath 547, is advanced through the lumen of guide
catheter 560 over guidewire 570 and part way into blood vessel 550.
Proper positioning of a distal end of evacuation sheath assembly
500 is confirmed using, for example, marker 545, nose cone 543, or
by viewing the braided sheath through imaging.
[0196] After the positioning is verified, the delivery sheath 547
is removed from the evacuation head 532. The actuation wire 513 is
then pulled proximally while the proximal hollow shaft 511 is held
stationary, preferably by a valve. Pulling the actuation wire 513
proximally longitudinally compresses the braided sheath forming
evacuation lumen 540, causing it to expand in diameter. The
evacuation lumen 540 expands and the proximal sealing surface 534
of the evacuation head 532 seals against the inside surface of the
guide catheter 560. The portion of the evacuation lumen 540
extending beyond the guide catheter 560 and into the blood vessel
550 continues to expand until the distal sealing surface 536 of the
evacuation head 532 seals against the inside surface of the blood
vessel 550. Similar to previous embodiments, the expansion can be
observed with fluoroscopy, and the blood pressure can be monitored
592 until the waveform changes from pulsatile arterial pressure to
a venous pressure (again, in the example of a coronary or SVG blood
vessel).
[0197] With both seals in place, normal blood flow is stopped. If
desired, contrast dye may be injected through the catheter lumen
into blood vessel 550 to view blood vessel 550 prior to treating
stenosis 580. Stenosis 580 is then treated and any embolic debris
is removed via retrograde flow 590 (FIG. 10D) as previously
described with respect to FIGS. 6C-6H. After treatment, the
actuation wire 513 is re-advanced to allow the braided sheath to
contract and be maintained in its reduced dimension prior to
withdrawing the evacuation sheath assembly 500 from blood vessel
550.
[0198] In use, the evacuation sheath assemblies 100, 200, 300, 400,
500 discussed previously may experience slow or limited retrograde
flow in certain vascular anatomies of some patients. This
limitation may cause incomplete removal of debris from the blood
vessel. In coronary applications of the invention, flow may be
limited by the lack of collateral vessels that connect to the
vessel being treated or because of the inability of the coronary
venous system to supply fluid flow rates capable of retrograde
removal of the debris, due, for example, to the presence of one-way
valve structures in the coronary veins. When this anatomy is
present, aspiration of the evacuation sheath assembly (as
represented by assembly 100 as described in connection with FIGS.
1A, 5A, and 6G) results in a short surge of retrograde movement of
the blood in the vessel, followed by a very slow continuous
retrograde flow. Methods for removing remaining particulate under
slow retrograde flow conditions are described below. These methods
are described with respect to the evacuation sheath assembly 100
and method of use of evacuation sheath assembly 100 previously
described in conjunction with FIGS. 6A-6I. However, these methods
can be utilized in conjunction with any of the evacuation sheath
assemblies and methods of use previously described herein.
[0199] While much of the particulate will move retrograde
(proximal) of the lesion site after the initial short surge of flow
and actually enter into the distal end 140b of the evacuation lumen
140, some of the particulate 197 may remain within the blood vessel
lumen 150. Furthermore, the relatively slow flow rate which follows
the initial surge in, for example, the types of anatomy mentioned
in the prior paragraph, may not be sufficient to urge the
particulate 197 into the evacuation lumen 140, and may also not be
sufficient to carry the particulate 197 to the proximal end 140a of
the evacuation lumen 140, into the guide catheter, and then into
the collection chamber 188.
[0200] When flow limiting anatomy is present, an alternative method
may be utilized to carry the particulate 197 from the lesion site,
into and completely through the evacuation lumen 140. Referring to
the point in the procedure shown in FIG. 6G, aspiration is applied
to the evacuation lumen 140, which causes an initial surge of
retrograde flow 195. Continued application of a vacuum to the
evacuation lumen 140, in spite of slow flow, may successfully
remove all the particulate 197 from the vessel 150 and from the
evacuation lumen 140. However, it is preferred to release the
vacuum after the initial retrograde surge, by turning off the
stopcock to the vacuum source 188. This allows for the lumen 150 of
the artery, which is still under a reduced pressure (and likely
under a negative pressure), to slowly refill and re-pressurize from
the venous circulation. After a few seconds, the vacuum is
re-applied to the evacuation lumen 140, causing a second retrograde
surge of fluid carrying particulate 197 from the lumen 150 of the
artery. This technique can be repeated as needed until all of the
particulate 197 is withdrawn fully into the evacuation lumen 140.
The repeated retrograde surges help assure that the particulate 197
passes into the evacuation lumen 140.
[0201] After the appropriate number of cycles of retrograde surges
have been performed, the sealing balloons 134, 136 are deflated
while a vacuum is applied to evacuation lumen 140, which creates
vigorous retrograde flow 195 in the evacuation lumen 140 by drawing
arterial blood from the aorta. After all the particulate 197 is
transported into the collection chamber 188, the vacuum is turned
off.
[0202] While the above technique is described in connection with
the embodiments shown in FIGS. 1A, 5A, and 6G, it is to be
understood that this technique could be adapted to other
embodiments of the invention, as well as to other parts of the
anatomy.
[0203] Another method may be employed in anatomical situations
where limited retrograde flow is experienced during use of any one
of the evacuation sheath assemblies described herein, for example
evacuation sheath assembly 100 in a coronary application (SVG or
native). FIG. 15 illustrates the posterior side of the heart,
showing the venous circulation. The coronary veins 2000 drain into
the coronary sinus 2010 and into the right atrium 2020. The
superior vena cava 2030 and inferior vena cava 2040 also drain into
the right atrium 2020.
[0204] One of the contributors to slow retrograde flow during use
of the evacuation sheath assembly 100 (as described previously) is
the presence of valves 2045 in the coronary veins 2000 and sinus
2010. These valves 2045, when present, are typically found at the
coronary sinus ostium, as well as at the ostia of the veins at the
coronary sinus 2010. These valves 2045 close when flow in the veins
is reversed, and venous pressure is reduced. Valve closure can be
avoided if the pressure within the coronary sinus 2010 and veins
2000 can be maintained at an elevated level. The elevated pressure
causes dilation of the sinus 2010 and veins 2000, which prevents
full closure of the valves 2045 in the presence of retrograde flow.
Therefore, if retrograde flow is induced in the evacuation sheath
assembly 100, this flow will draw from the venous circulation as
long as the valves 2045 in the venous circulation are prevented
from closing.
[0205] To maintain an elevated pressure in the coronary sinus 2010,
a coronary sinus occlusion catheter 2050 is employed. The occlusion
catheter 2050 may be delivered into the femoral vein, and into the
right atrium 2020 via the inferior vena cava 2040. The occlusion
catheter 2050 may include a pre-formed shape 2060 to facilitate
introduction into the coronary sinus 2010 and advancement over a
guide wire. Alternatively, the occlusion catheter 2050 can be
delivered with the assistance of a separate shaped guiding
catheter, as is known in the art. Angiographic imaging techniques
may be used in the placement of the occlusion catheter 2050.
Another alternative is to deliver the occlusion catheter 2050 from
a superior location via the subclavian or jugular vein, and into
the right atrium 2020 via the superior vena cava 2030.
[0206] As illustrated in FIG. 15, the occlusion catheter 2050
incorporates an occluding element 2070 which is preferably an
expandable balloon. A lumen (not shown) extends through the shaft
of the occlusion catheter 2050, to allow for continuous pressure
monitoring. In use, the occlusion catheter 2050 is placed at any
time prior to deflation of the stent balloon 193 (FIG. 6G) and
preferably placed just prior to inflation of balloons 134, 136 to
stop antegrade flow (FIG. 6C). The balloon 2070 is inflated until
the coronary sinus pressure increases enough to prevent closure of
the venous valves 2045. The pressure is monitored and the balloon
size adjusted accordingly. The steps previously described in
connection with FIGS. 6C-6I may then be performed. After the
procedure is complete, the occlusion catheter 2050 is removed.
[0207] Another alternative method of removing embolic debris in
this type of anatomy (which results in slow retrograde flow) is
provided. The steps necessary to remove embolic debris 197 from a
vessel 150 are essentially identical to the steps as previously
described with respect to FIGS. 6A-6G. The following steps allow
for the complete removal of debris 197 if slow or limited
retrograde flow is experienced.
[0208] In this method, interventional balloon 193a of
interventional device 193 occludes distal flow and aortic blood
provides the flow necessary for the retrograde removal of debris
197. To begin, the intervention balloon 193a is deflated after
positioning the stent (FIG. 6G), and the debris 197 is moved to a
position retrograde (proximal) of the treatment site, due to the
initial short surge of retrograde blood flow, which is followed by
relatively stagnant or slow retrograde flow. The retrograde flow is
then stopped by releasing the vacuum applied to the evacuation
lumen 140.
[0209] The balloon 193a of the stent delivery catheter 193 is then
re-inflated within the stent site 194. As shown in FIG. 13, while
intervention balloon 193a is inflated, a vacuum is applied to the
guide catheter 160, and the proximal and distal sealing balloons
134, 136 are deflated, allowing blood from the aorta 191 to flow
into the vessel 150 and past the end of evacuation sheath assembly
100. Preferably for this method, the guide catheter 160 and
evacuation head 132 are sized such that retrograde flow of blood
entering into the lumen of the guide catheter 160 enters primarily
via the lumen 140 of the evacuation head 132, and not directly into
the distal end of the guide catheter 160. This blood flow 191 is
then caught by the flow reversal caused by the vacuum applied to
the guide catheter 160, and reverses into the evacuation
sheath.
[0210] The meeting of the aortic blood flow 191 and the reverse
flow 195 causes a turbulent flow 196 in the fluid distal of the
evacuation sheath assembly 100. The reversing flow causes the
debris 197 to flow with retrograde fluid flow 195 into the
evacuation head 132, removing the debris 197 from the vessel 150.
The turbulent flow 196 extends distally of the distal tip of the
evacuation sheath assembly 100, effectively capturing particulate
197 which may be significantly distal of the evacuation sheath
assembly 100. It is preferable, however, to have the evacuation
sheath assembly 100 close enough to the lesion 180 to maximize the
particulate 197 captured. Preferably this distance is less than
about 10 cm.
[0211] Next, the vacuum is released, the balloon 193a of stent
delivery catheter 193 is deflated, and flow of blood in the
antegrade direction 190 is re-established. The stent delivery
catheter 193 is then removed from the vessel 150. While the above
description is made with respect to the therapeutic catheter being
a stent delivery catheter, other catheters may be employed as well,
as long as they are able to occlude antegrade flow through the
lesion during the aspiration step.
[0212] According to another aspect of the present invention, the
evacuation sheath assemblies 100, 200, 300, 400, 500 described
earlier may be used in conjunction with an infusion catheter to
supply fluid flow when slow or limited retrograde flow is
experienced. FIGS. 12A-12M show several variations of an infusion
catheter assembly.
[0213] FIGS. 12A-12C illustrate an embodiment of infusion catheter
assembly. Infusion catheter assembly 600 includes a distal shaft
690, which is preferably a multi-lumen tube. The distal shaft 690
is preferably made of a flexible polymer such as polyethylene,
Pebax.RTM., or Hytrel.RTM.. Alternatively, the distal shaft 690 can
be made of a composite polymer and metal material or from other
suitable biocompatible materials exhibiting, for example,
appropriate flexibility.
[0214] The infusion catheter assembly 600 includes a luer fitting
660 which creates a sealed connection between the infusion catheter
assembly 600 and a fluid source (not shown). The luer fitting 660
is connected to a proximal shaft 670, which is preferably made of a
metallic material or alternatively of a metal polymer composite or
other suitable biocompatible material. The proximal shaft 670
includes a proximal infusion lumen 640a and preferably extends to a
position just proximal to a proximal end 630a of a guide wire lumen
630.
[0215] Preferably, the proximal shaft 670 includes proximal shaft
markers 620 that provide a structure for determining when the
catheter has been advanced to a location just proximal to the
distal tip of the evacuation sheath assembly.
[0216] The distal shaft 690 includes two lumens. A distal infusion
lumen 640b is designed to allow for fluid flow, such as saline,
heparin/saline mixtures or radiographic dye, from the fluid source
and proximal infusion lumen 640 through the distal infusion lumen
640b. A guide wire lumen 630 is designed to allow for the passage
of a guide wire. The guide wire lumen 630 has proximal and distal
ends 630a, 630b. The proximal end 630a is positioned distal of the
proximal end 600a of the infusion catheter assembly 600. The distal
end of the distal shaft 690 is tapered to allow easy passage of the
assembly 600 through a blood vessel. Additionally, a radiopaque
marker 610 is attached near the distal end of the distal shaft 690
to allow the operator to visualize the infusion catheter assembly
600 by fluorscopy.
[0217] Additionally, the distal infusion lumen 640b communicates
with a multitude of infusion ports 650, which are preferably
disposed radially about the distal region of distal infusion lumen
640b and located less than 80 mm, preferably less than 40 mm, and
more preferably less than 20 mm from the distal tip. Alternatively
and/or additionally, ports may be provided longitudinally along a
distal end 640c of the distal infusion lumen 640b. The infusion
ports 650 are designed to allow for fluid flow from the proximal
infusion lumen 640a to distal infusion lumen 640b to exit the
infusion catheter assembly 600.
[0218] An alternative construction of a distal shaft 690 is shown
in FIGS. 12D-12F. In this construction, a single infusion port 650
is located at the distal end 640c of the distal infusion lumen
640b.
[0219] FIGS. 12G and 12H show a further alternative infusion
catheter assembly 700. The infusion catheter assembly 700 includes
an infusion/guide wire lumen 740 having a proximal end 740a and a
distal end 740b. Infusion/guide wire lumen 740 is contained within
an infusion catheter shaft 770 having a proximal end 755a and a
distal end 755b, which allows for the passage of a guide wire. The
infusion/guide wire lumen 740 is also designed to allow for fluid
flow within the infusion/guide wire lumen 740. This fluid flow may
occur regardless of whether a guide wire is within the
infusion/guide wire lumen 740. The infusion catheter shaft 770 is
preferably made of polyethylene. Alternatively, the infusion
catheter shaft 770 may be constructed of other polymers, polymer
and metal composites, or other suitable biocompatible
materials.
[0220] A luer fitting 760 is attached to the proximal end 740a of
the infusion catheter shaft 770. The luer fitting 760 creates a
sealed connection between the infusion catheter assembly 700 and a
fluid source (not shown). Luer fitting 760 may also include a
hemostatic valve 765 to seal around a guide wire placed within the
infusion/guide wire lumen 740. Infusion catheter shaft 770
preferably includes proximal marker bands 720 to provide a
structure for determining when the catheter has been advanced to a
location just proximal to the distal tip of the evacuation sheath.
Preferably, a radiopaque distal marker 710 is located about the
distal tip 755b of the infusion sheath shaft 770. Distal marker 710
provides visualization of the infusion sheath shaft 770 tip under
fluoroscopy.
[0221] A further alternative construction of an infusion catheter
700 is shown in FIGS. 12I and 12J. This construction is similar to
that of FIG. 12G, except that the catheter 700 of FIGS. 12I and 12J
has a reduced diameter at its distal end 755b. The reduced diameter
of distal end 755b is designed to make the infusion catheter 700
track more easily in tortuous vessel anatomies. Fluid flow within
the infusion/guide wire lumen 740 exits the infusion sheath shaft
770 at the distal end 755b. Fluid flow is allowable when a guide
wire is present or not present within the infusion/guide wire lumen
740. Fluid flow is improved within the infusion/guide wire lumen
740 when the guide wire is retracted proximally of the reduced
diameter region of the infusion/guide wire lumen 740.
[0222] An alternative to the catheter 700 of FIG. 12I is shown in
FIGS. 12K and 12L. Catheter 700 of FIGS. 12K and 12L also includes
a multitude of infusion ports 750, that are preferably disposed
radially about the distal end 740b of the infusion/guide wire lumen
740. The infusion ports 750 are preferably located a relatively
short distance from the distal end 755b of infusion catheter 700.
Fluid flow is within the infusion/guide wire lumen 740. This fluid
flow may occur regardless of whether a guide wire is within the
infusion/guide wire lumen 740 and extends distal of the distal end
755b.
[0223] FIGS. 12M and 12N show another infusion catheter assembly
800. The infusion catheter assembly 800 includes a proximal
infusion lumen 840a contained within a proximal shaft 870. The
proximal infusion lumen 840a is designed to allow for fluid flow
between a fluid source (not shown) and a distal infusion lumen
840b. The infusion catheter assembly 800 preferably does not
contain a guide wire lumen, and is delivered within the vessel
lumen without being tracked over the indwelling guide wire.
[0224] The infusion catheter assembly 800 has a luer fitting 860
that creates a sealed connection between the infusion catheter
assembly 800 and a fluid source (not shown). The luer fitting 860
is connected to the proximal shaft 870, which is preferably made of
a metallic material or alternatively a metal polymer composite, or
other suitable biocompatible material. The proximal shaft 870
contains proximal infusion lumen 840a and extends to be overlapped
by a distal shaft 890. Proximal shaft 870 and distal shaft 890
connect by an overlapping joint or other suitable connection
means.
[0225] Additionally, a stiffness transition member 880 is attached
to a distal end 870b of the proximal shaft 870. The stiffness
transition member 880, preferably made of stainless steel or
alternatively of other metals or composites, extends within the
infusion lumen 840b of the distal shaft 890. The stiffness
transition member 880 preferably has a stiffness that decreases
along its length from its proximal end 880a to its distal end 880b.
The decrease in stiffness is attributed to a reduction in the cross
sectional area of the member 880. The stiffness transition member
880 is preferably sealingly bonded to the distal end 890b of the
distal shaft 890 and may extend distally beyond the bond. The
portion of the stiffness transition member 880 that extends beyond
the distal shaft 890 is surrounded by and fixed to a spring coil
815. The spring coil 815 is preferably made of platinum or another
metal of a density suitable for visualization by fluoroscopy. The
stiffness transition member 880 and the spring coil 815 assembly
can be bent into a predetermined shape. The predetermined shape is
designed to help steer the assembly 800 through turns in the blood
vessel, without the need for tracking over the indwelling guide
wire. Alternately, there may be no distally extending spring coil
815. Preferably, the proximal shaft 870 contains proximal shaft
markers 820, providing a structure for determining when the
catheter has been advanced to a location just proximal to the
distal tip of the evacuation sheath.
[0226] Additionally, the distal infusion lumen 840b may include a
multitude of infusion ports 850 that are preferably disposed
radially about the distal infusion lumen 840b. The infusion ports
850 are designed to allow for fluid flow from the infusion lumen
840 to exit the infusion catheter assembly 800.
[0227] In use, the evacuation sheath assemblies discussed
previously may, as also noted previously, experience slow or
limited retrograde flow. When this condition is present, use of one
of the embodiments of infusion catheter assembly described above
may be used to facilitate removal of embolic material. FIG. 14
illustrates the use of an infusion catheter assembly, together with
an evacuation sheath assembly 100. A method for removing
particulate under slow retrograde flow conditions is described
below. This method is described with respect to the evacuation
sheath assembly 100 and method of use of evacuation sheath assembly
100 previously described in conjunction with FIGS. 6A-6I. However,
this method can be utilized with any of the evacuation sheath
assemblies and methods of use previously described herein.
[0228] The steps necessary to remove embolic debris 197 from vessel
150 are essentially identical to the steps described previously
with respect to FIGS. 6A-6G. Flow may be limited by the lack of
collateral vessels that connect to the vessel being treated,
because of the inability of the coronary venous system to supply
fluid flow rates capable of retrograde removal of the debris, or
for other reasons. The present method was developed to utilize an
infusion catheter assembly 600, 700, 800 to provide the fluid flow
necessary for the retrograde removal of debris 197. As shown in
FIG. 14, the infusion catheter assembly is represented by reference
numeral 175, however, any one of the infusion catheter assemblies
previously described herein may be used.
[0229] After the debris has been moved retrograde (proximal) of the
treatment site, the stent delivery catheter 193 is withdrawn from
the blood vessel. FIG. 14 shows the distal end of the infusion
catheter assembly 175 advanced beyond the treatment site. A vacuum
is then applied to the guide catheter 160. A fluid 176, such as
saline, heparinized saline, whole blood (drawn, for example, from
the ipsilateral or contralateral femoral artery) and/or radiopaque
dye, is then injected through the infusion catheter assembly 175
emerging from the infusion catheter assembly through infusion ports
178. The vacuum applied to the guide catheter 160 induces
retrograde flow 195 in the fluid distal to the treatment site and
proximate to the ports 178 of the infusion catheter assembly 175.
The reversing flow causes the debris to flow with the retrograde
flow 195 into the evacuation head 132, removing the debris 197 from
the vessel.
[0230] As long as the ports 178 of the infusion catheter assembly
175 are positioned distally of the treatment site, it is not
important that inflow of infused fluid be matched to outflow of
fluid removed through the evacuation sheath assembly 100. In fact,
it may be preferable to infuse fluid at a higher volumetric flow
rate than what is evacuated. In this manner, the blood vessel 150
will not be exposed to negative pressures, which may tend to
collapse the blood vessel 150 and prevent egress of fluid and
particulate.+
[0231] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims.
* * * * *