U.S. patent application number 11/109476 was filed with the patent office on 2005-11-03 for intravascular device and method of manufacture and use.
This patent application is currently assigned to SALIENT INTERVENTIONAL SYSTEMS, INC.. Invention is credited to Bolduc, Lee R., Laroya, Gilbert S., Lewis, B. Douglas.
Application Number | 20050245897 11/109476 |
Document ID | / |
Family ID | 32398190 |
Filed Date | 2005-11-03 |
United States Patent
Application |
20050245897 |
Kind Code |
A1 |
Bolduc, Lee R. ; et
al. |
November 3, 2005 |
Intravascular device and method of manufacture and use
Abstract
An intravascular device and method of constructing an
intravascular device. The device has a proximal portion which is
stiffer than a distal portion. The device of the present invention
may also be advanced through small vessels without the aid of a
guidewire although a guidewire may be used when necessary. The
device may be manufactured in a number of different ways and a
preferred method is to use an expanded PTFE liner at the distal
portion and an etched PTFE liner along the proximal portion. The
device also has a number of different jacket sections, preferably
at least four, with increasing durometer towards the proximal end
and a braided section with varying pic along the length.
Inventors: |
Bolduc, Lee R.; (Mountain
View, CA) ; Laroya, Gilbert S.; (Santa Clara, CA)
; Lewis, B. Douglas; (Stanford, CA) |
Correspondence
Address: |
HOEKENDIJK & LYNCH, LLP
P.O. BOX 4787
BURLINGAME
CA
94011-4787
US
|
Assignee: |
SALIENT INTERVENTIONAL SYSTEMS,
INC.
Cupertino
CA
|
Family ID: |
32398190 |
Appl. No.: |
11/109476 |
Filed: |
April 18, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11109476 |
Apr 18, 2005 |
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10616727 |
Jul 9, 2003 |
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10616727 |
Jul 9, 2003 |
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09434390 |
Nov 4, 1999 |
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6622367 |
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09434390 |
Nov 4, 1999 |
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09311903 |
May 14, 1999 |
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6295990 |
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09311903 |
May 14, 1999 |
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09243578 |
Feb 3, 1999 |
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09243578 |
Feb 3, 1999 |
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09018214 |
Feb 3, 1998 |
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6044845 |
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Current U.S.
Class: |
604/524 ;
29/447 |
Current CPC
Class: |
A61M 25/104 20130101;
A61M 2210/0693 20130101; A61M 25/0108 20130101; A61M 2025/0681
20130101; A61M 2025/0081 20130101; A61M 2025/0079 20130101; Y10T
29/49906 20150115; A61B 2017/22084 20130101; A61M 2025/1079
20130101; A61M 2025/1095 20130101; Y10T 29/49885 20150115; A61M
25/0068 20130101; Y10T 29/49865 20150115; A61M 2202/0208 20130101;
A61M 25/007 20130101; A61M 25/10 20130101; A61B 17/22 20130101;
A61M 25/008 20130101; A61B 2017/22082 20130101; Y10T 29/49863
20150115; A61M 25/0032 20130101; A61B 2017/22077 20130101; A61M
2025/0004 20130101; A61M 25/003 20130101 |
Class at
Publication: |
604/524 ;
029/447 |
International
Class: |
A61M 025/00 |
Claims
1. A method of forming an intravascular device, comprising the
steps of: mounting an expanded PTFE liner over a first mandrel
portion; winding a reinforcing layer over the expanded PTFE liner
after the mounting step; and applying a first jacket over the
reinforcing layer and expanded PTFE liner after the winding and
mounting steps.
2. The method of claim 1, further comprising the steps of: covering
the jacket, reinforcing layer and expanded PTFE liner with a shrink
tube; fusing the coating layer to the expanded PTFE liner to form
an integrated structure; and removing the shrink tube after the
fusing step.
3. The method of claim 1, wherein: the applying step is carried out
by positioning a tube of material over the reinforcing layer.
4. The method of claim 1, further comprising the steps of:
positioning an etched PTFE liner over a second mandrel portion; and
the winding step is carried out with the reinforcing layer being
wound over the etched PTFE liner; and the applying step is carried
out with the jacket layer being positioned over the reinforcing
layer and the etched PTFE liner after the winding step.
5. The method of claim 4, wherein: the applying steps are carried
out with the jacket layer having a first jacket section and a
second jacket section, the first jacket section being positioned
over the expanded PTFE liner and the second jacket section being
positioned over the etched PTFE liner, the first jacket section
having a durometer which is at least 30 D less than the second
jacket section.
6. The method of claim 5, wherein: the applying steps are carried
out with the first jacket section having a durometer which is at
least 40 D less than the second jacket section.
7. The method of claim 1, wherein: the positioning steps are
carried out with the expanded PTFE liner having a porosity of 8-10
microns.
8. The method of claim 4, wherein: the first mandrel portion and
second mandrel portion are part of the same mandrel.
9. The method of claim 1, further comprising the step of: inverting
an end of the expanded PTFE liner at a distal end.
10. The method of claim 9, wherein: the inverting step is carried
out to form an inverted portion of the expanded PTFE liner which
extends longitudinally at least 0.5 mm from a distal end of the
reinforcing element.
11. An intravascular device, comprising: a liner layer having a
first liner section, the first liner section being made of expanded
PTFE; a reinforcing layer wound over the liner layer; and a jacket
positioned over the reinforcing layer and fused with the liner
layer.
12-86. (canceled)
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a continuation-in-part of
application Ser. No. 09/311,903, filed May 14, 1999, which is a
continuation-in-part of application Ser. No. 09/243,578, filed Feb.
3, 1999, which is a continuation-in-part of application Ser. No.
09/018,214, filed of Feb. 3, 1998, the full disclosures of which
are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to intravascular
devices and methods. Intravascular devices are used to access
various areas of the vasculature for a variety of reasons. Such
devices are used to deliver and withdraw fluids and to deliver
other devices such as stents, angioplasty balloons and thrombolytic
devices.
[0003] A specific application of the present invention is for
treating acute arterial ischemia in areas such as the brain. The
devices and methods of the present invention are particularly
useful in connection with the devices and methods described in U.S.
patent application Ser. No. 09/311,903, filed May 14, 1999 by Lewis
and Bolduc which describe devices for treating acute ischemia. The
invention may, of course, be used in other locations in the body
for any other purpose.
SUMMARY OF THE INVENTION
[0004] The present invention is directed to intravascular devices
and methods of construction. As an example of a use of the present
invention, methods and devices for treating ischemia resulting from
the partial or total obstruction of a blood vessel are described.
Usually, the obstructions will be high-grade blockages, e.g., those
which result in greater than 75% flow reduction, but in some
instances they may be of a lower grade, e.g., ulcerated lesions. As
used hereinafter, the terms "obstruction," "occlusion," and
"blockage" will be used generally interchangeably and will refer to
both total obstructions where substantially all flow through a
blood vessel is stopped as well as to partial obstructions where
flow through the blood vessel remains, although at a lower rate
than if the obstruction were absent.
[0005] Preferred use of the present invention is for the treatment
of patients suffering from acute stroke resulting from a sudden,
catastrophic blockage of a cerebral artery. The invention may also
be used to minimize or prevent ischemia during other conditions
which result in blocked points or segments in the cerebral arterial
vasculature, such as iatrogenic occlusion of an artery, e.g.,
during neurosurgery, or to relieve vasospasm induced ischemia. The
present invention, however, will also be useful for treating acute
blockages in other portions of the vasculature as well as for
treating chronic occlusions in the cerebral, cardiac, peripheral,
mesenteric and other vasculature. Optionally, the methods of the
present invention may be used to facilitate dissolving or removing
the primary obstruction responsible for the ischemia, e.g., by drug
delivery, mechanical intervention, or the like, while perfusion is
maintained to relieve the ischemia.
[0006] Methods according to the present invention comprise
penetrating a perfusion conduit through the blockage and
subsequently pumping an oxygenated medium through the conduit at a
rate or pressure sufficient to relieve ischemia downstream from the
blockage. The oxygenated medium is preferably blood taken from the
patient being treated. In some instances, however, it will be
possible to use other oxygenated media, such as perfluorocarbons or
other synthetic blood substitutes. In a preferred aspect of the
present invention, the pumping step comprises drawing oxygenated
blood from the patient, and pumping the blood back through the
conduit at a controlled pressure and/or rate, typically a pressure
within the range from 50 mmHg to 400 mmHg, preferably at a mean
arterial pressure in the range from 50 mmHg to 150 mmHg, and at a
rate in the range from 30 cc/min to 360 cc/min, usually from 30
cc/min to 240 cc/min, and preferably from 30 cc/min to 180 cc/min,
for the cerebral vasculature. Usually, pressure and flow rate will
both be monitored. The blood flow system preferably keeps the
pressure at or below 400 mmHg, 350 mmHg, or 300 mmHg. Pressure is
preferably monitored using one or more pressure sensing element(s)
on the catheter which may be disposed distal and/or proximal to the
obstruction where the blood or other oxygenated medium is being
released. Flow rate may easily be monitored on the pumping unit in
a conventional manner or may be monitored by a separate control
unit. Conveniently, the blood may be withdrawn through a sheath
which is used for percutaneously introducing the perfusion
conduit.
[0007] It will usually be desirable to control the pressure and/or
flow rate of the oxygenated medium being delivered distally to the
occlusion. Usually, the delivered pressure of the oxygenated medium
should be maintained below the local peak systolic pressure and/or
mean arterial blood pressure of the vasculature at a location
proximal to the occlusion. It will generally be undesirable to
expose the vasculature distal to the occlusion to a pressure above
that to which it has been exposed prior to the occlusion. Pressure
control of the delivered oxygenated medium will, of course, depend
on the manner in which the medium is being delivered. In instances
where the oxygenated medium is blood which is being passively
perfused past the occlusion, the delivered pressure will be limited
to well below the inlet pressure, which is typically the local
pressure in the artery immediately proximal to the occlusion.
Pressure control may be necessary, however, when the oxygenated
medium or blood is being actively pumped. In such cases, the pump
may have a generally continuous (non-pulsatile) output or in some
cases may have a pulsatile output, e.g., being pulsed to mimic
coronary output. In the case of a continuous pump output, it is
preferred that the pressure in the vascular bed immediately distal
to the occlusion be maintained below the mean arterial pressure
usually being below 150 mmHg, often being below 100 mmHg. In the
case of a pulsatile pump output, the peak pressure should be
maintained below the peak systolic pressure upstream of the
occlusion, typically being below 200 mmHg, usually being below 150
mmHg.
[0008] Pressure control of the oxygenated medium being delivered
downstream of the occlusion is preferably achieved using a digital
or analog feedback control apparatus where the pressure and/or flow
output of the pump is regulated based on a measured pressure and/or
flow value. The pressure value may be measured directly or
indirectly. For example, the pressure downstream of the occlusion
may be measured indirectly through the perfusion conduit. A
separate pressure lumen may be provided in the perfusion conduit
and a pressure measurement transducer located at the proximal end
of the conduit. Pressure sensed by a distal port of the pressure
measuring conduit will then be transmitted through the conduit to
the transducer. Pressure transducers are a preferred pressure
sensor for measuring pressure in the vasculature distal to the
occlusion. The pressure sensors may be mounted near the distal tip
of the perfusion conduit itself or could be mounted on a separate
guidewire or other structure which crosses the occlusion with the
perfusion conduit. The pressure signals generated by the
transducers are transmitted through electrically conductive
elements, such as wires, to the proximal end of the perfusion
conduit where they are connected to a pressure monitor connected to
or integral with the controller. The pump output can then be
controlled based on conventional control algorithms, such as
proportional control algorithms, derivative control algorithms,
integral control algorithms, or combinations thereof. In one
embodiment of the present invention, the pressure sensor is spaced
from the perfusion outlets so that fluid flow forces do not affect
the pressure measurements.
[0009] Actual manipulation of the pressure and/or flow provided by
a circulating pump can be effected in a variety of ways. In the
case of centrifugal pumps, the flow can be measured at the pump
output and the pressure can be measured in any of the ways set
forth above. Control of both the flow rate and the pressure can be
achieved by appropriately changing the pump speed and downstream
flow resistance, where the latter can be manipulated using a
control valve. Suitable flow control algorithms are well described
in the patent and technical literature.
[0010] Control of peristaltic and other positive displacement pumps
is achieved in a slightly different way. Flow volume from a
positive displacement pump is a linear function of the pump speed
and thus may be controlled simply by varying the pump speed.
Pressure output from the positive displacement pump, in contrast,
will be dependent on flow resistance downstream from the pump. In
order to provide for control of the output pressure from the pump
(which is necessary to control the pressure downstream of the
occlusion), a pressure control system may be provided. Typically,
the pressure control system may comprise a by-pass flow loop from
the pump output back to the pump inlet. By then controlling the
amount of blood output which is by-passed back to the inlet, that
pressure can be manipulated. Typically, a flow control valve can be
used to adjust the by-pass flow in order to achieve the target
pressure control point downstream of the obstruction. Suitable flow
and pressure control algorithms for positive displacement pumps,
such as roller pumps, are well described in the patent and
technical literature.
[0011] In addition to controlling pressure and/or flow rates, the
systems of the present invention can provide control for a number
of other parameters, such as partial oxygen pressure (pO2) in the
perfused blood, partial carbon dioxide pressure (pCO2) in the
perfused blood, pH in the perfused blood, temperature of the
perfused blood, metabolite concentrations, and the like. Both pO2
and pCO2 can be controlled using the oxygenator in the system, as
described in more detail below. The pH can be controlled by
introducing appropriate physiologically acceptable pH modifier(s),
such as buffer and bicarbonate solutions and the like. Temperature
is controlled by providing appropriate heat exchange capabilities
in the extracorporeal pumping system. The temperature will usually
be decreased in order to further inhibit tissue damage from the
ischemic conditions, but could be elevated for other purposes.
Suitable sensors and devices for measuring each of the parameters
are commercially available, and suitable control systems can be
provided as separate analog units or as part of a digital
controller for the entire system, such as a desk or lap top
computer which is specially programmed to handle the monitoring and
control functions as described in this application. Concentration
and/or physiologic activity of certain formed cellular elements,
such as white blood cell or platelets, can be selectively
controlled with suitable control systems and devices
[0012] A particular advantage of the present invention lies in the
ability to lessen or eliminate reperfusion injury which can result
from the rapid restoration of full blood flow and pressure to
ischemic tissue. As described above, the use of thrombolytics and
other prior treatments can cause the abrupt removal of an
obstruction causing rapid infusion of blood into the ischemic
tissue downstream of the occlusion. It is believed that such rapid
restoration of full blood flow and pressure, typically at normal
physiologic pressures, can result in further damage to the leaky
capillary beds and dysfunctional blood-brain barrier which results
from the prior ischemic condition.
[0013] The present invention allows for a controlled reperfusion of
the ischemic tissue where blood can initially be released
downstream of the obstruction at relatively low pressures and/or
flow rates. That is, it will be desirable to initiate the flow of
blood or other oxygenated medium slowly and allow the flow rate and
pressure to achieve their target values over time. For example,
when actively pumping the oxygenated medium, the pumping rate can
be initiated at a very low level, typically less than 30 cc/min,
often less than 10 cc/min, and sometimes beginning at essentially
no flow and can then be increased in a linear or non-linear manner
until reaching the target value. Rates of increase can be from 1
cc/min/min to 360 cc/min/min, usually being from 5 cc/min/min to
120 cc/min/min. Alternatively, the flow of blood or other
oxygenated medium can be regulated based on pressure as mentioned
above. For example, flow can begin with a pressure in the
previously ischemic bed no greater than 10 mmHg, typically from 10
mmHg to 70 mmHg. The pressure can then be gradually increased,
typically at a rate in the range from 5-100 mmHg over 2, 8 or even
48 hours. In some instances, it may be desirable to employ blood or
other oxygenated medium that has been superoxygenated, i.e.,
carrying more oxygen per ml than normally oxygenated blood.
[0014] While pumping will usually be required to achieve and/or
maintain adequate perfusion, in some instances passive perfusion
may be sufficient. In particular, perfusion of the smaller arteries
within the cerebral vasculature can sometimes be provided using a
perfusion conduit having inlet ports or apertures on a proximal
portion of the conduit and outlet ports or apertures on a distal
portion of the conduit. By then positioning the inlet and outlet
ports on the proximal and distal sides of the obstruction,
respectively, the natural pressure differential in the vasculature
will be sufficient to perfuse blood through the conduit lumen past
the obstruction. Usually, the inlet ports on the perfusion conduit
will be positioned at a location as close to the proximal side of
the occlusion as possible in order to minimize the length of
perfusion lumen through which the blood will have to flow. In some
instances, however, it may be necessary to position the inlet ports
sufficiently proximal to the occlusion so that they lie in a
relatively patent arterial lumen to supply the necessary blood flow
and pressure. The cross-sectional area of the perfusion lumen will
be maintained as large as possible from the point of the inlet
ports to the outlet ports. In this way, flow resistance is
minimized and flow rate maximized to take full advantage of the
natural pressure differential which exists.
[0015] While perfusion is maintained through the perfusion conduit,
treatment of the blood vessel blockage may be effected in a variety
of ways. For example, thrombolytic, anticoagulant and/or
anti-restenotic agents, such as tissue plasminogen activator (tPA),
streptokinase, urokinase, heparin, or the like, may be administered
to the patient locally (usually through the perfusion catheter) or
systemically. In a preferred aspect of the present invention, such
thrombolytic and/or anticoagulant agents may be administered
locally to the arterial blockage, preferably through a lumen in the
perfusion catheter itself. Such local administration can be
proximal to the thrombus or directly into the thrombus, e.g.,
through side infusion ports which are positioned within the
thrombus while the perfusion port(s) are positioned distal to the
thrombus. Optionally, a portion of the blood which is being
perfused could be added back to or otherwise combined with
thrombolytic and/or anticoagulant agent(s) being administered
through the catheter. The addition of blood to certain thrombolytic
agents will act to augment the desired thrombolytic activity. The
availability of the autologous blood being perfused greatly
facilitates such addition. It would also be possible to deliver the
agent(s) through the same lumen and distal port(s) as the blood
being pumped back through the perfusion lumen so that the agents
are delivered distally of the catheter. The latter situation may be
used advantageously with neuroprotective agents, vasodilators,
antispasmotic drugs, angiogenesis promoters, as well as
thrombolytics, anticoagulants, and anti-restenotic agents, and the
like. The two approaches, of course, may be combined so that one or
more agents, such as thrombolytic agents, are delivered directly
into the thrombus while neuroprotective or other agents are
delivered distally to the thrombus. Moreover, such delivery routes
can also be employed simultaneously with systemic delivery of drugs
or other agents to the patient.
[0016] Alternatively or additionally, mechanical interventions may
be performed while the vasculature is being perfused according to
the present invention. For example, a perfusion conduit may have a
very low profile and be used as a guide element to introduce an
interventional catheter, such as an angioplasty catheter, an
atherectomy catheter, a stent-placement catheter, thrombus
dissolution device, or the like.
[0017] The perfusion of the oxygenated medium may be performed for
a relatively short time in order to relieve ischemia (which may be
advantageous because of damaged capillaries and/or blood-brain
barrier) while other interventional steps are being taken, or may
be performed for a much longer time either in anticipation of other
interventional steps and/or while other long-term interventions are
being performed. In particular, when thrombolytic and/or
anticoagulant agents are being used to treat the primary blockage,
the perfusion can be continued until the blockage is substantially
relieved, typically for at least thirty minutes, often for four to
eight hours, or even 2-3 days. In other instances, perfusion can be
maintained for much longer periods, e.g., more than one week, more
than two weeks, more than a month, or even longer. In some cases,
it may even be desirable to maintain perfusion and placement of the
perfusion conduit for an extended period of time with the patient
having a portable or implantable pump coupled to the conduit. The
pump may also have a reservoir for delivery of therapeutic agents
and may be implanted or carried on a belt or the like.
[0018] The ability of the present invention to provide for gradual
or controlled restoration of physiologic blood perfusion pressures
and flow rates is a particular advantage when subsequent
interventional steps would otherwise result in abrupt restoration
of blood flow. As described above, abrupt restoration of blood flow
can cause or contribute to reperfusion injuries. By providing for
controlled restoration of blood flow prior to such interventional
steps, the ischemic tissue can be conditioned to tolerate
physiologic blood flow rates and pressures prior to full
restoration by dissolution or other removal of the occlusion. Such
gradual restoration of blood flow from very low levels to
physiologic flow rates can typically be achieved over time periods
in the range from one minute, an hour or even up to 48 hours or
longer. Perfusion at controlled pressure and/or flow rate may last
typically in the range of 30 minutes to 2 hours, more typically 30
minutes to 9 hours. It will be desirable, for example, to initiate
perfusion through the perfusion conduits of the present invention
at mean arterial pressures downstream of the occlusion which are no
greater than 25-50% of normal with typical pressures being 20-40
mmHg. The blood flow rates which correspond to such pressures will
depend largely on the nature of the vasculature into which the
blood is being perfused and may be less than 200 ml/min, less than
150 ml/min and even less than 100 ml/min.
[0019] In addition to delivering oxygen to the ischemic region
distal to the primary occlusion, the blood or other oxygenated
medium may carry other treatment agents, including thrombolytic
agents, anticoagulant agents, tissue preservative agents, and the
like. Moreover, in order to further preserve the cerebral tissue
distal to the blockage, the oxygenated medium may be cooled to
below body temperature, e.g., to a temperature in the range from
2.degree. C. to 36.degree. C., typically from 25.degree. C. to
36.degree. C., in order to cool and preserve the tissue. Cooling
may be effected externally as part of the extracorporeal pumping
system and/or may be effected using a thermoelectric or
Joule-Thomson expansion cooler on the catheter itself.
[0020] Patients suffering from ischemia resulting from acute or
chronic occlusion in the cerebral vasculature may be treated
according to the preferred methods described below. A perfusion
conduit is introduced to the patient's vasculature, and a distal
port on the conduit is guided through the occlusion in the cerebral
vasculature. Blood, optionally oxygenated and/or superoxygenated,
is obtained from the patient and perfused back to the patient
through the distal port on the conduit past the occlusion at a rate
sufficient to relieve the ischemia. The oxygenated blood may be
arterial blood which may be returned to the patient without further
oxygenation. Alternatively, arterial or venous blood can be
oxygenated in suitable apparatus external to the patient and
returned to the patient. External oxygenation allows the blood to
be "superoxygenated," i.e., oxygenated at higher levels than would
normally be available from arterial blood. Usually, the method
further comprises delivering a therapeutic agent to the patient
while the perfusing step is continued, usually being a thrombolytic
agent which is delivered through the conduit directly to the
vascular occlusion. The occlusion is usually in either a carotid
artery, vertebral artery, proximal subclavian artery,
brachiocephalic artery, or an intracerebral artery, and the conduit
is usually introduced via the femoral artery in a conventional
intravascular approach, typically being positioned over a guidewire
which is first used to cross the occlusion. Alternatively, the
conduit may be introduced through the axillary or brachial
arteries, also in a conventional manner. The conduit may also be
advanced through the vasculature and through the occlusion without
the aid of a guidewire as will be discussed below.
[0021] Apparatus according to the present invention comprises
perfusion/infusion catheters which include a catheter body having a
proximal end and a distal end. The catheter body has at least a
perfusion lumen and may have other lumens. The catheter may be
tapered or may have a constant cross-sectional shape. The catheter
may be formed as a single, multi-lumen or single-lumen extrusion or
the lumens may be formed as separate tubes. When formed as separate
tubes, the tubes may be fixed relative to each other or may be
provided with appropriate sliding seals to permit them to slide
relative to each other. Additional lumens and/or tubes may also be
provided for purposes discussed in more detail below. Often,
although not always, the catheters will be free from external
dilatation balloons or other external structure which could
complicate penetration of the distal end of the catheter through an
obstruction.
[0022] A first embodiment of the catheter is characterized by a
large diameter proximal section and a small diameter distal
section, where at least two isolated lumens extend from the
proximal end of the catheter body through both sections to near the
distal end of the catheter body. One of the lumens will extend
entirely through the catheter body and usually have side ports over
a distal length thereof. The other lumen will usually terminate
some distance proximal of the distal tip of the catheter body and
will also usually have side ports over a distal length thereof. The
proximal section has an outer diameter in the range from 1 mm to 3
mm, usually from 1.5 mm to 2.5 mm, and typically from 1.5 mm to 2
mm, and the distal section has an outer diameter in the range from
0.5 mm to 2 mm, preferably from 0.5 mm to 1.5 mm. The first
isolated lumen which extends entirely through the catheter body
will usually be tapered, i.e., have a larger diameter over a
proximal length thereof than over a distal length thereof. Usually,
the first isolated lumen will have an inner diameter in the range
from 0.75 mm to 1.25 mm in the proximal section, more usually being
from 0.9 mm to 1.1 mm in the proximal section, and an inner
diameter in the range from 0.25 mm to 1 mm in the distal section,
usually being from 0.3 mm to 0.75 mm in the distal section. The
second isolated lumen will usually be disposed annularly about the
first isolated lumen and will have an inner diameter in the range
from 0.9 mm to 2.9 mm in the proximal section, usually from 1.4 mm
to 1.9 mm in the proximal section, and an inner diameter in the
range from 0.4 mm to 1.9 mm in the distal section, usually in the
range from 0.5 mm to 1.5 mm in the distal section. The second,
outer annular lumen will typically terminate from 5 cm to 25 cm
from the distal end of the catheter body.
[0023] The catheter may also have a larger flow conduit for
achieving higher flow rates. For example, the inner diameter of the
first lumen may be 1.5-3.0 mm in the proximal section and 1.0-2.0
mm in the distal section. The second lumen has an inner diameter
which is preferably 0.25-1.0 mm larger than the outer diameter of
the first lumen. The wall thickness of the first lumen is
preferably between 0.07-0.20 mm. If the catheter has a straight
instead of tapered configuration the inner diameter of the first
lumen is preferably 1.5-2.5 mm.
[0024] The catheter of the present invention may, of course, have
any other suitable tapered shape or may have a constant
cross-sectional profile. For example, in another preferred
embodiment, the first catheter has the perfusion lumen, and in a
specific embodiment no other fluid lumens. Such a catheter has a
small, flexible construction which can be passed through tortuous
vessels. Other catheters may be advanced over the perfusion
catheter to remove or displace the obstruction as discussed below.
The catheters may be another fluid perfusion catheter for delivery
of thrombolytic agents or may be an obstruction removal catheter
which removes the obstruction with mechanical action or with an
ultrasound transducer, RF electrode or a laser.
[0025] In another aspect of the present invention, the perfusion
conduit is advanced through the cerebral vasculature to the
obstruction and an obstruction removal catheter is advanced through
the perfusion lumen to remove the obstruction. Thus, the perfusion
conduit acts as a fluid conduit and/or a guide catheter for
reaching distal regions of the cerebral vasculature. The system of
the present invention permits the introduction of catheters through
the perfusion lumen to regions as distal as the middle cerebral
artery M1 and M2 segments, anterior cerebral artery A1 and A2
segments, and the basilar artery or other similarly sized vessels
which are typically accessed with guidewires. The obstruction
removal catheter may be a balloon, stent, perfusion, RF,
ultrasound, laser or mechanical atherectomy catheter for removing
the obstruction. As will be discussed below, the catheters of the
present invention may also be advanced without the aid of a
guidewire.
[0026] The present invention is also directed to a system having a
balloon catheter and an infusion catheter. The balloon catheter has
at least one lumen extending therethrough. The second catheter has
a guide tip and fluid infusion openings in a distal region. Both
catheters have a proximal region which has a cross-sectional area
greater than the distal region. The second catheter is slidably
received in the first catheter so that the guide tip and the fluid
infusion openings can extend distally from the first catheter.
[0027] In another method of the present invention, a method of
performing balloon displacement of an obstruction in a patient's
vasculature is provided. A balloon catheter is guided over a
guidewire to a site in a patient's vasculature. The guidewire is
then removed. An infusion catheter is then introduced through the
balloon catheter. The infusion catheter is advanced through the
balloon catheter so that the tip extends beyond the balloon
catheter. An infusate is then delivered through the infusion
catheter.
[0028] In still another aspect of the present invention, a balloon
catheter is provided which is configured to be guided through the
perfusion catheter. The balloon catheter has no guidewire lumen and
no other structure to track over a guidewire thereby reducing the
size of the catheter. The distal end of the balloon catheter
preferably has a smooth, rounded tip to penetrate the obstruction
if necessary. The balloon catheter may have a tapered shape similar
to the perfusion catheter.
[0029] The devices of the present invention may be manufactured in
any suitable manner. In another aspect of the invention, a
preferred method of constructing the devices described above is to
position a liner over a mandrel and wind a reinforcing layer over
the liner. Ajacket is then positioned over the liner and a shrink
tube is positioned over the jacket. The entire structure is then
heated to fuse the jacket to the liner.
[0030] The device preferably has a flexible distal portion to
navigate small and tortuous vessels and a stiff proximal portion to
provide column strength for advancing the device through the
vascular system. The distal portion of the liner is preferably made
of expanded PTFE which provides flexibility. The proximal portion
of the liner is preferably made of etched PTFE so that the proximal
portion has greater stiffness and column strength. An end of the
expanded PTFE liner is everted to form a soft, atraumatic distal
end.
[0031] In a preferred embodiment, the jacket has a number of
sections, preferably about five. The jacket preferably has
increasing stiffness distally. The flexural modulus of the jacket
preferably increases at least 25, more preferably at least 40
times, and most preferably about 55 times from a distal section to
a proximal section. Specifically, the jacket flexural modulus
increases from 2000 psi at a distal section to 110,000 at a
proximal section. The jacket sections also preferably increases in
durometer towards the proximal end. The jacket preferably increases
at least 13 D, more preferably at least 25 D, over a distance of no
more than 10 cm, more preferably no more than 8 cm, for three
successive sections. The jacket may also have a fourth section with
the first section being at least 25 D less than the fourth section
and the first and fourth sections separated by 15 cm or less, more
preferably 10 cm or less. The jacket may also have a fifth section
with the first section having a durometer which is at least 28 D
less than the fifth section. The first section is preferably
separated from the fifth section by 20 cm or less and preferably 15
cm or less. The jacket may even have a sixth section with the first
section having a durometer which is at least 40 D less than the
sixth section. The first and sixth sections are separated by at
least 25 cm or even 20 cm.
[0032] The reinforcing layer also has a number of sections with the
distal section being coil and the proximal sections being braided
wire. The braided wire has four sections with decreasing pics
toward the proximal end. The first section has a pic which is at
least 20 more than the third section. The first section is
preferably separated from the first section by no more than 15 cm
and preferably no more than 10 cm. The reinforcing layer may also
have a fourth section with the first section having a pic which is
at least 30 pics more than the fourth section. The first section is
separated from the fourth section by no more than 20 cm and more
preferably no more than 15 cm.
[0033] The catheter of the present invention has a large change in
stiffness between the proximal and distal sections. Specifically,
the proximal section is at least 20, 40, 60 or even 75 times
stiffer than the distal portion of the catheter. The distal portion
preferably extends at least 10 or even 15 cm from the distal end
while the proximal portion extends to within 40, 35 and most
preferably to within 30 cm from the distal end or closer. The high
change in stiffness permits the proximal portion to be rigid enough
to prevent buckling and kinking while the distal portion is
flexible to pass through tortuous vessels. Although the distal
portion is relatively flexible, the distal portion still retains a
relatively large column strength so that the distal end may be
advanced through the vasculature without the aid of a guidewire. A
guidewire may, of course, be used at times when needed.
[0034] Apparatus according to the present invention further
comprise systems including a perfusion/infusion catheter as set
forth above in combination with a sheath for percutaneously
introducing the perfusion/infusion catheter and a pump for
receiving blood from the sheath and delivering blood back to the
catheter. Optionally, an infusion device may be provided in the
system for infusing a drug to a lumen of the perfusion/infusion
catheter. Preferably, the systems will include control apparatus
for controlling blood infusion pressures, blood infusion flow
rates, pO2, pCO2, pH, temperature, and/or other parameters of the
blood/oxygenated medium being perfused back to the patient. The
present invention still further comprises kits, including a
perfusion catheter and instructions for use setting forth a method
for penetrating the catheter through a blockage in a patient's
vasculature and thereafter perfusing an oxygenated medium through
the conduit to relieve ischemia. Kits will usually further comprise
a container, such as a pouch, tray, box, tube, or the like, which
contains the catheter as well as the instructions for use.
Optionally, the instructions for use set forth on a separate
instructional sheet within the package, but alternatively could be
printed in whole or in part on the packaging itself. Optionally,
other system components useful for performing the methods of the
present invention could be provided within the kit, including
guidewires, introductory sheaths, guiding catheters, and the
like.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] FIGS. 1A-1C illustrate an exemplary protocol for treating a
total occlusion in a blood vessel according to the method of the
present invention.
[0036] FIG. 2 illustrates an exemplary system for treating a total
occlusion within a patient's cerebral vasculature according to the
present invention.
[0037] FIG. 3 is a cross-sectional view taken along line 3-3 of
FIG. 2.
[0038] FIG. 4 is a cross-sectional view taken along line 4-4 of
FIG. 2.
[0039] FIG. 5 is a cross-sectional view taken along line 5-5 of
FIG. 2.
[0040] FIG. 6 is a cross-sectional view taken along line 6-6 of
FIG. 2.
[0041] FIG. 7 illustrates a protocol using the system of FIG. 2 for
treating a cerebral occlusion according to the present
invention.
[0042] FIG. 8 is a detailed view of the catheter used for treating
the occlusion in the protocol of FIG. 7.
[0043] FIG. 9 illustrates a kit including components according to
the present invention.
[0044] FIG. 10 illustrates an alternative embodiment of a perfusion
conduit constructed in accordance with the principles of the
present invention.
[0045] FIG. 11 illustrates yet a further embodiment of a perfusion
conduit constructed in accordance with the principles of the
present invention.
[0046] FIG. 12 illustrates yet another exemplary embodiment of a
perfusion conduit constructed in accordance with the principles of
the present invention.
[0047] FIG. 13 illustrates another perfusion catheter with a second
catheter advanced over the perfusion catheter.
[0048] FIG. 14 illustrates a perfusion used in connection with the
catheters of FIG. 13.
[0049] FIG. 15 illustrates another perfusion catheter having a
balloon inflated by fluid infused through the fluid lumen;
[0050] FIG. 16 illustrates a still another perfusion catheter
having a balloon with an inflation lumen.
[0051] FIG. 17 illustrates a perfusion catheter with a stent
delivery catheter advanced over the perfusion catheter.
[0052] FIG. 18 illustrates a perfusion catheter with a balloon
catheter advanced over the perfusion catheter.
[0053] FIG. 19 shows another system for treating a cerebral
obstruction.
[0054] FIG. 20 shows a balloon catheter displacing an obstruction
in a cerebral artery.
[0055] FIG. 21 shows another balloon catheter having a second
lumen.
[0056] FIG. 22 shows a stent displacing an obstruction in a
cerebral artery.
[0057] FIG. 23 shows a perfusion catheter for removing the
obstruction.
[0058] FIG. 24 shows another system for treating a cerebral
obstruction having first and second tapered catheters.
[0059] FIG. 25 is an enlarged view of the distal end of the
catheters of FIG. 23.
[0060] FIG. 26 is a cross-sectional view of the distal end of the
catheters of FIGS. 23 and 24 with a lumen in a relaxed state;
[0061] FIG. 27 is a cross-sectional view of the catheters of FIG.
23 with the lumen expanded.
[0062] FIG. 28 is shows the system of FIG. 24 with an alternative
second catheter having an expandable lumen.
[0063] FIG. 29 shows the catheter of FIG. 29 having an expandable
sidewall in a collapsed condition.
[0064] FIG. 30 shows the expandable sidewall in an expanded
position.
[0065] FIG. 31 is an exploded view showing a method of constructing
an interventional device.
[0066] FIG. 32 is a cross-sectional view showing the method of
constructing the interventional device of FIG. 31.
[0067] FIG. 33 is a cross-sectional view of the device of FIG. 32
after heating to fuse the layers together to form an integrated
device.
[0068] FIG. 34 shows the distal end of the device with the liner
having an inverted portion at the distal end.
[0069] FIG. 35 is a cross-sectional view of another device.
[0070] FIG. 36 is another cross-sectional view of the device of
FIG. 35.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
[0071] The intravascular devices and methods of construction and
use are described below. The present invention is described in
connection with treating partial or total occlusions but may be
used for any other suitable purpose. The general principles for
treating partial and total occlusions within a patient's
vasculature are described in connection with FIGS. 1A-1C. A blood
vessel BV which is usually an artery, more usually a cerebral
artery, such as a carotid artery, vertebral artery, or an
intracerebral artery, is obstructed by a total occlusion TO. The
occlusion may result from thrombosis at a pre-existing
atherosclerotic lesion or may result from the shedding of an
embolus from an artery which flows distally to the particular
vessel in which the occlusion occurs. Usually, the occlusion will
occur abruptly and the sudden loss of perfusion through the blood
vessel distal to the total occlusion TO will place the patient at
great risk of neuron death. As discussed above in the Background
section, it is usually necessary to reestablish perfusion within a
matter of hours in order to avoid significant tissue damage or
death, particularly in the case of strokes. While six hours is
often considered a maximum delay, earlier treatment is much more
desirable.
[0072] The present invention provides a method for very quickly
reestablishing perfusion through the total occlusion TO in a
controlled manner. Such perfusion is established using a perfusion
conduit 10 (FIG. 1C) through which oxygenated blood or an
oxygenated synthetic medium, such as a perfluorocarbon oxygen
carrier, is actively pumped back through a lumen of the catheter
from a source 12. Usually, the conduit will include side perfusion
ports 14 near its distal end 16 in order to less traumatically
disperse the perfused fluid. Optionally, proximal portions of the
conduit 10 (not shown) may have enlarged lumen diameters in order
to reduce flow resistance and shear forces to further reduce or
prevent hemolysis. It will be appreciated that while the distal
portion of the conduit 10 will usually have a relatively low
profile to access small diameter blood vessels, the proximal
portions can be made significantly larger to improve the
hemodynamic flow and handling characteristics and reduce
hemolysis.
[0073] Optionally, the conduit 10 will be introduced over a
conventional guidewire GW which may be initially used to cross the
total occlusion TO, as shown in FIG. 1B. In other instances,
however, the perfusion conduit 10 may be adapted so that it is able
to cross the total occlusion TO without the use of a conventional
guidewire. In some cases, the perfusion conduit may be in the form
of a guidewire, e.g., a tapered guidewire, which is suitable for
both guiding through the vasculature to the site of the total or
partial occlusion as well as crossing the occlusion.
[0074] The perfusion conduit 10 may be introduced from any normal
intravascular introduction site, e.g., through the femoral artery
using the Seldinger technique. Alternatively, the infusion conduit
can be introduced through the axillary and other arteries.
[0075] A system 20 suitable for treating occlusions within the
cerebral vasculature is illustrated in FIGS. 2-6. The system 20
includes a perfusion conduit in the form of intravascular catheter
22. The catheter 22 comprises a catheter body 24 having a distal
end 26 and a proximal end 28. The catheter body 24 comprises a pair
of coaxial tubular elements, including an outer tube 30 and an
inner tube 32. Proximal hub 34 comprises a first port 36 which is
fluidly coupled to an interior lumen of the inner tube 32 and a
second port 38 which is fluidly coupled to an annular lumen between
the exterior surface of outer tube 32 and the interior of tube 30.
Proximal port 40 (typically a hemostasis valve) also communicates
with the lumen of the inner tubular member 32 and is suitable for
intravascular positioning of the catheter 22 over a guidewire.
[0076] The system usually further includes a guiding catheter 50
having dimensions and characteristics suitable for introducing the
catheter 22 to the desired intravascular target site. Although
illustrated as having a straight configuration, the guiding
catheter 50 will often have a preformed, curved tip selected
specifically to reach the intravascular target site, and the
guiding catheter could further be reinforced (e.g., braided), have
a variable stiffness over its length, have a variable diameter, or
the like. The system 20 will usually still further comprise a
sheath 60 which is used to percutaneously access the vasculature at
the introductory site, e.g., in the femoral artery. The sheath 60
has a proximal hub 61 including at least one side arm 62. The hub
61 receives the catheter 22 therethrough and will include a
mechanism for maintaining hemostasis about the catheter. The side
arm 62 permits withdrawal of blood for oxygenation and return to
the patient according to the present invention. Other side arm(s)
may be provided for removal of blood (optionally combined with
drugs being delivered back to the patient), for infusing agents
through the sheath 60, or for other purposes. Entry of blood into
the lumen of the sheath is optionally facilitated by side ports 64
formed over at least a distal portion of the sheath. The catheter
body 24 is tapered in the distal direction, i.e., the diameter is
larger near the proximal end 28 than at the distal end 26. As
illustrated in FIGS. 2-6, the outer tube 30 has a large diameter
proximal section (observed in FIG. 3) and a smaller diameter distal
section (observed in FIGS. 4 and 5). Similarly, the inner tube 32
has a large diameter proximal section (shown in FIG. 3) and a
smaller diameter distal section (shown in FIGS. 4-6). The
particular outer diameters and inner lumen diameters of both the
outer tube 30 and inner tube 32 are within the ranges set forth
above. Since the distal terminii of the outer tube 30 and inner
tube 32 are staggered, the catheter body 24 is tapered in three
stages, with a first diameter reduction occurring at location 33
(FIG. 2) where the diameter of the outer tubular member 30 is
reduced from the diameter shown in FIG. 3 to the diameter shown in
FIG. 4. The second diameter reduction occurs at location 35 where
the outer tubular member 30 terminates, leaving the outer surface
of the inner tubular member 32 to define the catheter body.
[0077] Such tapered configurations are preferred since they
maximize the cross-sectional area of the flow lumens over the
length of the catheter to reduce flow resistance for both the blood
(or other oxygenated medium) and the drug to be delivered. As can
be seen in FIG. 3, lumen 70 of the inner tubular member 32 which
carries the blood is maximized until the diameter is reduced near
the distal end of the catheter, as shown in FIG. 4. Similarly, the
annular lumen 72 which carries the drug is maximized over the
proximal portion before it is reduced after the transition at
location 33. Maintaining the larger diameters and lumen areas is
desirable in order to decrease flow resistance and shear forces to
reduce or eliminate hemolysis as the blood is introduced through
the entire catheter length. Similarly, a reduction in flow
resistance to the drug being introduced facilitates drug delivery
during the procedure.
[0078] Side wall penetrations 80 are provided in a distal portion
26 of the outer tubular member 30, as best seen in FIGS. 2 and 5.
The penetrations 80 will be useful for delivering a therapeutic
agent through port 38 in order to treat the primary occlusion, as
described in more detail hereinafter.
[0079] Similarly, ports 90 may be formed over at least a distal
portion of the inner tubular member 32 which extends beyond the
distal end of the outer tubular member 30. The penetrations 90 will
be available to release blood or other oxygenated medium that is
being perfused back to the patient through port 36 and the
continuous lumen of the tube 32. Note that while the lumen 70 of
tube 32 will be available for introduction of the catheter 22 over
a guidewire, the guidewire may be at least partially withdrawn from
the lumen 70 in order to further decrease blood flow resistance as
it is perfused back to the patient.
[0080] Optionally, the catheter 22 may comprise at least one
pressure sensing element 96 disposed at a location near where the
blood or other oxygenated medium is returned to the blood vessel.
Preferably, the pressure sensing element 96 may be a piezoelectric
or other solid state pressure sensing device and will be connected
through the hub 34 by a pair of wires 97 which may be connected to
conventional electronic devices for measuring pressure. Thus,
pressure may be measured and used for controlling rate and/or
pressure of blood or other oxygenated medium pumped back to the
patient using conventional analog or digital control circuitry. A
pressure control point will be selected, usually within the ranges
set forth above, and the rate or pressure of oxygenated medium
being pumped back through the catheter 22 will be controlled to
maintain the control point. Conventional control algorithms, such
as proportional, derivative, integral, and combinations thereof,
may be employed for maintaining the desired control point.
[0081] In some instances, it will be desirable to provide at least
a second pressure sensing element 98 which will be located proximal
to the obstruction when the catheter is in use. For example, the
pressure sensing element 98 may be near the location 35 where the
outer tubular member 30 terminates. The sensor 98 will permit
monitoring of the pressure in the vasculature proximal of the
occlusion, which pressure will usually approximate that of the
vasculature in the region of the occlusion prior to an acute
occlusion event. This pressure, in turn, may be utilized as a
target pressure for the blood or other oxygenated medium which is
being perfused distal to the occlusion. That is, it may be
desirable to treat the measured "background" pressure as a maximum
desirable pressure for perfusion in order to prevent injury to the
vasculature distal to the occlusion.
[0082] Referring now to FIG. 7, use of the system 20 for treating
the cerebral vasculature of a patient P will be described. Access
to the target cerebral artery is established using the sheath 60 in
a conventional manner. The guiding catheter 50 is then introduced
through the sheath 60 and establishes a protected access lumen to a
location within the cerebral vasculature. The catheter 22 is then
introduced through the guiding catheter to the target site within
the cerebral vasculature, typically over a guidewire (not
illustrated). Conveniently, the catheters will be partly radiopaque
and/or radiopaque markers 92 (FIG. 2) will be provided at the
distal tip of the catheter as well as on either side of the drug
ports 80 so that the catheter 22 may be properly positioned under
fluoroscopic guidance relative to the obstruction being treated.
After the tip 26 of the catheter 22 is penetrated through the
occlusion TO (FIG. 8) the penetrations 80 are preferably located
within the occlusive material in order to deliver the thrombolytic
or other agent to the material. The distal portion of the catheter,
including ports 90, in contrast, are located beyond the occlusive
material in order to provide the desired blood perfusion. Blood
flow is immediately established using an external pump 100 which
receives blood from the port 62 of access sheath 60 and returns the
oxygenated blood to the catheter 22 through port 36. Any suitable
therapeutic agent, such as a thrombolytic agent, may be introduced
through port 38 from a source 102. Any other suitable drugs may
also be delivered from the source 102 and through the port 38.
Optionally, the blood may be cooled before, during, or after it has
passed through the pump unit 100. Still further optionally, the
blood may be oxygenated or superoxygenated using an
oxygen-saturated bubble chamber or conventional cardiopulmonary
bypass oxygenators ORS. In some instances, it may be desirable to
combine the thrombolytic agent with a portion of the recirculating
blood before infusing the thrombolytic agent/blood back through the
port 38.
[0083] Optionally, the pump unit 100 may be controlled by an analog
or digital control unit 110 (FIG. 7). The control unit 110 will
receive various input control parameters 112, typically including
at least oxygenated medium flow rate and pressure. Other control
parameters, such as pO2, pCO2, pH, temperature, and the like, may
also be input into the control unit 110. In turn, the control unit
will provide a control output 114, typically at least to the pump
unit 100 to control output flow and pressure, as described above.
If control of other parameters is desirable, other capabilities may
be added, such as the ability to control the degree of oxygenation
in the medium supplied by source 102, the ability to add pH
modifiers, such as buffers, bicarbonate, and the like, to the
oxygenated medium, the ability to control a heat exchanger located
in the blood flow circuit, and the like. The source 102 may provide
any of the various drugs or therapeutic agents described herein for
delivery through the ports.
[0084] Kits according to the present invention are illustrated in
FIG. 9. The kit will include a perfusion conduit, such as perfusion
conduit 10, as well as instructions for use 120. The catheter and
instructions for use will usually be combined within a suitable
container, such as a pouch, tray, box, tube, or the like. The
catheter and possibly other components of the system (such as guide
catheters, sheaths, thrombolytic or other therapeutic agents,
disposable cartridges for pump/oxygenation systems, or the like)
will optionally be included and/or sterilized within the packaging.
The instructions for use may be on a separate sheet of paper or may
be printed in whole or in part on the packaging materials. The
instructions will set forth a method of using the devices in any
manner described herein. Furthermore, the kit may include any
grouping of instruments described herein without departing from the
scope of the invention.
[0085] Referring now to FIG. 10, a perfusion conduit 200 includes
an inner tube 202 and outer tube 204. The inner tube has perfusion
ports 206 formed in its side wall over a portion of the distal end,
and the outer tube 204 has perfusion ports 208 formed over a
portion of its distal end. The perfusion conduit 200 differs from
catheter 22 primarily in that the inner tubular member 202 is able
to slide axially relative to the outer tubular member 204. A
sliding seal 210, typically an O-ring or similar passive seal, is
provided to maintain pressure within the lumen of outer tubular
member 204 so that thrombolytic and other drugs can be delivered
without excessive loss through the distal tip. Some loss of the
agent, however, will usually be acceptable so that the seal need
not be completely tight. If a more positive seal is desired, an
inflatable balloon 211 (shown in broken line) may be provided in
addition to or in place of the sliding seal 210. Use of the balloon
211 is advantageous in that it permits higher infusion pressures
without leakage from the distal end of the outer tube 204, but
disadvantageous in that it limits the range of axial placement of
the outer tube 204 relative to the inner tube 202. Use of the inner
tube 202 for perfusing blood or other oxygenated medium
therethrough will generally be as described with the prior
embodiments. Radiopaque markers 212 and 214 on the inner tube 202
will be positioned distally of the occlusion to assure that the
perfusion ports 206 will release the delivered blood with minimal
resistance. Radiopaque markers 216 and 218 on outer tube 208, in
contrast, will be positioned so that the infusion ports 208 lie
generally within the occluded region. Optionally, the balloon 212
will be inflated to both lock the inner and outer tubes relative to
each other and to provide a positive seal at the distal end of the
outer tube, and the thrombolytic or other therapeutic agent will
then be delivered through the lumen of the outer tube into the
occlusive material, such as thrombus.
[0086] Referring now to FIG. 11, a perfusion conduit 300 also
includes an inner tube 302 and an outer tube 304. The inner and
outer tubes are slideable relative to each other, and a sliding
seal 310 is provided at the distal end of the outer tube 304. The
perfusion conduit 300, in contrast to prior embodiments, is not
intended to deliver a therapeutic agent. Instead, it is intended
only to perfuse blood or other oxygenated medium therethrough. The
lumen 312 within the outer tube 304 is intended for passing the
blood or other oxygenated medium to near the distal end of the
conduit 300. The inner tube 302 then receives the blood or other
oxygenated medium through ports 314 which permit the medium to flow
from lumen 312 into the interior lumen of the tube 302. An enlarged
portion 316 of the tube 302 is provided in order to prevent axial
advancement of the tube so that the ports 314 cannot extend outside
of the outer tube 304. Alternatively or additionally, an inflatable
balloon 316 may be provided in order to both prevent excess axial
advancement of the inner tube 302 and provide a more positive seal.
Usually, since the blood will be perfused at lower pressures than
might be used for drug delivery, use of the balloon 316 for
isolation will often not be necessary. The perfusion conduit 300
can thus provided reduced flow resistance for the blood or other
oxygenated medium being returned to the patient through the
conduit. Additionally, the ability to slide the outer tube 304
relative to the inner tube 302 helps the tubes be properly
positioned relative to each other depending on the circumstances of
the patient being treated.
[0087] Referring now to FIG. 12, a perfusion conduit 400 intended
for passive perfusion, i.e., without active pumping, is
illustrated. The catheter 400 usually comprises a single extrusion
having a proximal section 402 with an enlarged diameter and a
distal section 404 with a reduced diameter. The proximal and distal
diameters will generally be in the ranges set forth above. Blood
inlet ports 408 are provided on the catheter near its proximal end
while blood outflow ports 410 are provided near the distal end. The
relative positions of the inflow ports 408 and outflow ports 410
allow the perfusion conduit 400 to be introduced to a patient so
that the inflow ports are proximal to the occlusion while the
outflow ports 410 are distal to the occlusion. The inflow ports 408
are usually relatively near to the distal end of the proximal
section 402 having the enlarged diameter in order to decrease the
overall flow resistance between the inflow ports 408 and outflow
ports 410. Generally, however, the inflow ports 408 will be
positioned so that they will lie proximally of the occlusion so
that the occluding material does not block blood flow into the
inflow ports. In some instances, they will be spaced proximally of
the transition 412 from large diameter to small diameter by a
distance in the range from 1 cm to 15 cm, usually from 2 cm to 10
cm, to assure proper placement in the vasculature. The inflow ports
408 are thus able to receive blood and pass the blood distally
through the large diameter section with minimum pressure drop. A
pressure drop through the narrow diameter section 404 will be
greater, in many instances the total pressure drop of the conduit
400 will be sufficiently low so that adequate blood perfusion can
be maintained to relieve patient ischemia. Optionally, the conduit
400 could have a slideable structure, as shown in conduit 300 of
FIG. 11, but such structure will increase the flow resistance and
will not be preferred in all instances. The conduit 400 preferably
has a ID of 0.5 mm to 1.8 mm, more preferably 0.75 to 1.5 mm,
between the inflow and outflow ports.
[0088] Referring to FIGS. 13 and 14, another catheter 500 is shown
which has a perfusion conduit 502. The catheter 500 has a rounded,
atraumatic distal end 504 which is preferably guided through the
vasculature over a guidewire which is advanced ahead of the
catheter 500. The perfusion conduit 502 may have any of the shapes
and sizes discussed herein and preferably has a cross-sectional
size of 0.77 to 7.1 mm2, more preferably 1.7 to 2.9 mm2 along a
distal portion 506 of the catheter 500. In order to maintain
adequate flow rates at acceptable pressures, the cross-sectional
size is preferably at least 1.7, more preferably at least 3.0 and
most preferably at least 4.2 mm2 along the distal portion 506. The
distal portion 506 extends for a length of at least 5, 10,15, 20 or
25 cm from distal end 507 or from the most proximal outlet 518.
[0089] The catheter 500 and conduit 502 are sized large enough to
provide sufficient blood flow rates while blood pressure is within
allowable limits to prevent hemolysis. Specifically, the conduit
502 is sized so that the pressure of oxygenated blood in the
catheter is 0-400 mmHg, more preferably 20-350 mmHg, at blood flow
rates of at least 30, 80, 120 or 160 ml/min. Furthermore, the
overall length of the catheter 500 is preferably at least 120, 150
or 175 cm depending upon the access site and size of the
patient.
[0090] The overall maximum outer dimension of the catheter 500
shaft along the distal portion 506 is preferably no more than 1.6
mm, 2.3 mm, or 3.2 mm. The various diameters and dimensions given
throughout the application are equally applicable to any other
suitable embodiments described herein. For example, all catheter
dimensions discussed above are suitable dimensions for catheter 500
and all dimensions for catheter 500 are applicable to other
catheters described herein. Although catheter 500 may include
additional open lumens, such as balloon inflation, vent or pressure
lumens, the catheter 500 preferably includes only the perfusion
conduit 502 to minimize the overall size. The catheter 500 may also
be a passive inflation catheter such as the passive inflation
catheter 400 of FIG. 12.
[0091] The catheter 500 may include proximal and distal pressure
sensors 510, 512 for measuring pressure on both sides of the
obstruction. In a preferred embodiment, the catheter 500 has only
one pressure sensor 512 and only the perfusion conduit 502. Wires
514 extending through or along shaft are coupled to a pressure
monitor 516 which in turn is integral with or coupled to the
control unit 110 for controlling the pump 100 in any manner
described herein. The distal pressure sensor 512 is preferably
positioned a distance A which is at least 0.5 cm more preferably at
least 1 cm, from the most proximal outlet 518 so that pressure
measurement is not distorted by flow forces from the fluid perfused
through the outlets 518. A heater and/or cooler 517 is also
provided for heating or cooling the oxygenated medium. The control
unit 110 also receives input control parameters 112 with the
parameters measured with suitable sensors along the fluid line.
[0092] The pressure is preferably maintained below normal arterial
pressure for a period of time to protect the previously ischemic
bed from reperfusion injury. The inventor believes that prematurely
exposing the ischemic bed to normal arterial pressure may cause
reperfusion injury and that maintaining low pressure for a period
of time can minimize or eliminate reperfusion injury. Low pressure
in the previously ischemic bed can be maintained by pressure
feedback control of the pump 100 as mentioned above. Alternatively,
low pressure can be maintained without direct measurement and
feedback by simply selecting low perfusion flow rates.
[0093] A second catheter 520 is slidably coupled to the catheter
500 and is advanced into the vascular system with the catheter 500
guiding the second catheter 520 to the obstruction. The catheter
500 passes through a hemostasis valve 521 in the second catheter
520. The second catheter 520 passes over the catheter 500 but may
also have an interlocking relationship with the catheter 500. The
second catheter 520 may also be completely independent from the
catheter 500 since advancing the second catheter 520 quickly may
not be necessary with catheter 500 perfusing and protecting the
previously ischemic vascular bed.
[0094] The second catheter 520 has a lumen 522 defined by the
annular space between the catheters 500, 520. The lumen 522 may be
used to deliver liquids, including any of the therapeutic agents
described herein such as a thrombolytic agent, from a liquid source
524. The second catheter 520 may also be coupled to a vacuum source
526 to vent blood, therapeutic byproducts and emboli through lumen
522.
[0095] The second catheter 520 may also include an obstruction
removal device 528 for removing the obstruction. The obstruction
removal device 528 may simply be the distal tip of the catheter 520
which is used to mechanically remove the obstruction. The
obstruction removal device 528 may also be any suitable
non-mechanical device such as an ultrasound transducer, an RF
electrode, or a laser. FIG. 13 shows the obstruction removal device
528 as an ultrasound transducer coupled to a power source 531 (FIG.
14) with wires 534. The wires 534 may float within lumen 522 or may
be embedded in the wall of the catheter 520. If the obstruction
removal device is an RF electrode, a suitable second electrode (not
shown) is placed in contact with the patient's body for monopolar
RF or on either catheter 500, 520 for bipolar RF. An electrically
conductive fluid, such as saline, may be passed through the lumen
522 from the liquid source 524 during activation of the RF
electrode for enhanced conduction. Thus, the second catheter 520 is
used to remove the obstruction by mechanical disruption, delivery
of obstruction removing liquids through the lumen 522 or use of any
of the other suitable devices mentioned above.
[0096] Referring to FIG. 15, another perfusion catheter 600 is
shown which has a perfusion conduit 602. The catheter 600 also has
an expandable member 604 which is preferably an inflatable balloon
606 but may also be a mechanically actuated device. The expandable
member 604 prevents the previously ischemic bed from being exposed
to full arterial pressure if the obstruction is cleared prematurely
before the perfusion therapy is completed. The balloon 606 may also
be used to prevent parts of the obstruction or other emboli from
flowing downstream before therapeutic agents or other obstruction
removing methods are used to dissolve, destroy, displace or
otherwise remove the obstruction.
[0097] The balloon 606 has an inflation hole 608 leading to the
perfusion conduit 602 so that perfusion of fluid through the
conduit 602 inflates the balloon 606. An advantage of using the
perfusion conduit 602 to inflate the balloon 606 is that a separate
inflation lumen is not required which minimizes the size of the
catheter 600. Referring to FIG. 16, the perfusion catheter 600 may
also include a separate inflation lumen 610 for inflating the
balloon 606 so that the balloon 606 may be selectively inflated
independent of perfusion. The balloon 606 may also be used for
flow-directed placement of the catheter 600.
[0098] Referring to FIG. 17, a stent delivery catheter 700 is
passed over the perfusion catheter 500, which may be any of the
perfusion catheters described herein, and a balloon 702 is used to
expand a stent 704 and open the artery. Referring to FIG. 18, a
balloon catheter 706 having a balloon 708 is advanced over the
perfusion catheter 500. The balloon 708 is expanded in the
obstruction to displace the obstruction and open the artery. An
advantage of the present system is that the perfusion catheter 500
perfuses and protects of the previously ischemic bed while the
stent 704 or balloon 708 is positioned and deployed.
[0099] Referring to FIG. 19, another system 710 for treating the
cerebral vasculature is shown. The system 710 includes the catheter
500 which may be any of the catheters 10, 400, 600 described above
or any other suitable alternative. A catheter 712 passes through
the catheter 500 and is used to remove or displace the obstruction
in the cerebral vasculature. As will be described in specific
embodiments below, the catheter 712 may be a balloon catheter 714
(FIGS. 20 and 21), a stent catheter 716 (FIG. 22) or a perfusion
catheter 718 (FIG. 23). The catheter 712 may, of course, use any
other suitable method for removing the obstruction including a
laser, microwave, ultrasound, RF or a mechanical device.
[0100] The system 710, and in particular the catheter 500, may also
be used in any manner described above. For example, the catheter
500 may be used to infuse oxygenated medium to treat an ischemic
region prior to introduction of catheter 712. After infusion of the
oxygenated medium for a period of time, the catheter 712 is used as
described below. The catheter 500 preferably has the dimensions and
characteristics of any suitable catheter described herein. In
particular, the lumen 502 preferably has the necessary dimensions
to provide for adequate infusion while being small enough to
provide a flexible catheter which can pass into distal regions of
the cerebral vasculature. The distal portion is preferably at least
5, 10 15 or 20 cm in length. The lumen along the distal portion has
a cross-sectional area of 0.45 to 2.3, more preferably 0.62 to 1.8,
and most preferably 0.62 to 1.7 mm2. When the cross-sectional shape
of the lumen is circular, the diameter of the lumen 502 is
preferably 0.76-1.52 mm, more preferably 0.89-1.40 mm and most
preferably 0.89-1.27 mm along the distal portion. The maximum
cross-sectional dimension along the distal portion (which is simply
the outer diameter for a circular cross-section) is preferably no
more than 0.41 mm, 0.31 mm or 0.20 mm larger than the diameter of
the lumen 502. Thus, the maximum cross-sectional dimension is
preferably no more than 1.2, 1.1 or 1.0 mm when the diameter of the
lumen 502 is 0.76 mm.
[0101] The catheter 500 also preferably has a proximal portion
which extends for a length of at least 75 or 100 cm. The lumen 502
has a cross-sectional area of 2.0-7.6, more preferably 2.8-5.6 mm2,
and most preferably about 3.2-5.1 mm2 along the proximal portion.
When the lumen 502 has a circular cross-sectional shape, the lumen
502 has a diameter of 1.52-2.92 mm, more preferably 01.09-2.67 mm,
and most preferably 1.89-2.54 mm. The maximum cross-sectional
dimension along the proximal portion is preferably no more than
0.41, 0.31 or 0.20 mm larger than the diameter of the lumen 502.
The catheter 500 may also have an intermediate section which has a
length of 20-40 and preferably about 30 cm. The intermediate
section has a cross-sectional size between the size along the
proximal and distal sections. In a preferred embodiment, the
intermediate section has a constant taper between the proximal and
distal portions.
[0102] The catheter 500 has a hemostasis valve 713 which receives
the catheter 712. The introducer sheath 60 may also be used for
introducing the catheter and for withdrawing and directing blood
and other fluids from a fluid system 715 which is the system of
FIGS. 7 or 14 described above.
[0103] An advantage of the catheter 500 is that the catheter 500
can be used to guide the balloon catheter 714, or any other
catheter, to distal portions of the cerebral vasculature.
Specifically, the catheter 500 is flexible enough to reach the
middle cerebral artery M1 and M2 segments, anterior cerebral artery
A1 and A2 segments, and basilar artery and preferably to distal
regions which are accessible depending upon the size of the
patient's vasculature. These regions are typically accessed by
advancing the catheter over a guidewire rather than through another
catheter. An advantage of using the catheter 500 rather than a
traditional guidewire is that the catheter 500 protects the
vasculature as the catheter 500 is advanced. Another advantage is
that the catheter 500 may be used to infuse fluids, such as the
oxygenated medium and therapeutic agents prior to, during and after
introduction of the obstruction removal catheter 712.
[0104] Referring to FIGS. 19 and. 20, the balloon catheter 714 has
a balloon 718 which displaces the obstruction. An inflation lumen
720 is coupled to a source of inflation fluid 722 (FIG. 19) for
inflating the balloon 718. The catheter 714 may have more lumens,
however, the catheter 714 has only the inflation lumen 720 to
minimize the size of the balloon catheter 714. Since the catheter
714 does not track over a conventional guidewire, the catheter 714
also does not have a guidewire lumen or other structure to track
over a guidewire which further reduces the size of the balloon
catheter 714. The balloon catheter 714 also preferably has no
distal opening so that the catheter 714 has a smooth, atraumatic
tip which can be advanced through the obstruction if necessary.
Thus, the balloon catheter 714 of the present invention provides
advantages over conventional balloon catheters which track over
guidewires.
[0105] The balloon catheter 714 is preferably sized and configured
to provide a space 723 between the catheters 714, 500 so that the
lumen 502 of catheter 500 may be used while the balloon catheter
714 is positioned therein. The balloon catheter 714 may generally
have the tapered shape within the range of shapes of the catheters
500 so that the balloon catheter 714 essentially conforms to the
shape of the lumen of the catheter 500. Such a configuration
facilitates advancement of the balloon catheter 714 through the
catheter 500. The distal portion of the catheter has a
cross-sectional area of no more than 1.5 mm2 more preferably no
more than 1.0 mm2 over a distal portion 724 of the catheter 714.
The distal portion 724 preferably extends at least 5 cm and more
preferably at least 10 cm from a distal end 726. The maximum outer
dimension of the catheter 714 over the distal portion 724 may also
be no more than 1.2 mm, 0.8 mm, 0.75 mm and most preferably no more
than 0.65 mm in diameter.
[0106] In another preferred method of the present invention, the
catheter 500 is advanced through the obstruction to infuse
oxygenated medium into the ischemic bed as described above. When
the ischemic bed has been adequately perfused at the desired rates
and pressures, the catheter 500 may be withdrawn through the
obstruction. During withdrawal of the catheter, the lumen 502 may
be coupled to the vacuum source 526 to capture emboli (FIG. 19).
The balloon 718 may be positioned to lie within the obstruction as
the catheter 500 is withdrawn, it may be advanced by itself through
the obstruction after withdrawal of the catheter, or may be pulled
back to lie within the obstruction by advancing the balloon beyond
the obstruction within the catheter 500 before withdrawing the
catheter 500. Once the balloon 718 is positioned within the
obstruction, the balloon 718 is inflated to displace the
obstruction as shown in FIG. 20. The lumen 502 may also be used to
vent blood and thereby suction emboli while inflating the balloon
718. Although the catheter 714 preferably has only the inflation
lumen 722, the catheter 714 may also have in infusion lumen 728 as
shown in FIG. 21. The infusion lumen 728 is coupled to the system
of FIG. 7 or 14 to infuse oxygenated medium and other fluids distal
to the obstruction as described above, but the catheter 714 is
otherwise used in the same manner as catheter 714.
[0107] Referring to FIG. 22, another system is shown which is
similar to the system of FIG. 19 except that the stent catheter 716
is used instead of the balloon catheter 714. The stent catheter 716
is used in substantially the same manner as the balloon catheter
714 in that a stent 732 displaces the obstruction. The stent 732 is
mounted to a balloon 734 having a lumen 736 coupled to the
inflation source 722. The inflation lumen 736 is preferably sized
like the lumen 728 and the preferred dimensions of the stent
catheter 716 are the same as described above for the balloon
catheter 714. The stent catheter 716 offers the same advantages as
the balloon catheter 714 in that the stent catheter 716 does not
require a guidewire lumen or other structure to track over a
conventional guidewire. The stent 732 may be a suitable
conventional stent 732 mounted to the catheter 716 of the present
invention. The stent catheter 716 may also have a perfusion lumen
and outlet 719, which may be a number of outlets or sideholes, for
perfusing fluids as described above.
[0108] Referring to FIG. 23, the catheter 712 may also be the
perfusion catheter 718 which passes through the catheter 500. The
perfusion catheter 718 has a lumen 738 coupled to a source of
solution 740 which is used to remove or dissolve the obstruction
(FIG. 19). The perfusion catheter 718 is advanced through the
catheter 500 so that openings 740 are positioned in or near the
obstruction. The openings 740 may be at the distal end or spaced
from the distal end. The catheter 500 is then withdrawn through the
obstruction while venting through the lumen 738 with the vacuum
source 526 to remove emboli. After the catheter 500 has been
withdrawn, the solution is delivered through the perfusion catheter
718 and the dissolved obstruction can be withdrawn through the
lumen 502 in the catheter 500 using the vacuum source 526. The
catheter 500 and perfusion catheter 718 are both coupled to the
system of FIGS. 7 or 14 for periodic infusion of the oxygenated
medium as necessary. The lumen 738 preferably has a cross-sectional
area of no more than 1.54 mm2 and more preferably no more than 0.3
mm2, and most preferably no more than 0.19 mm2 along the distal
portion of at least 5 cm. The maximum outer dimension of the
catheter along the distal portion is preferably no more than 1.4 mm
and more preferably no more than 0.95 mm and most preferably no
more than 0.50 mm so that the lumen of the catheter 500 may still
be used to suction the dissolved obstruction with the perfusion
catheter 718 contained therein.
[0109] Although it is preferred to pass the catheters 714, 716, 718
directly through the catheter 500 thereby obviating the need to
track over a guidewire, the catheters 714, 716, 718 may also be
advanced over a guidewire which is advanced through the vasculature
within the lumen 502 of catheter 500. Conventional guidewires are
typically 0.014 inch to 0.018 inch in diameter and constructed to
be flexible enough to reach the distal regions of the cerebral
vasculature described above. After the guidewire has reached the
desired location, a catheter can be advanced over the guidewire. At
this point in the procedure, the guidewire must be rigid, rather
than flexible, so that the catheter tracks over the guidewire
without displacing the guidewire itself.
[0110] The devices and methods of the present invention permit the
use of relatively large guidewires for advancement of catheters
through the cerebral vasculature. This system does not require the
use of smaller, more flexible guidewires since the guidewire is
advanced through the catheter 500 rather than independently. The
system promotes significant stability beyond that provided by
conventional guidewires. The guidewire and corresponding guidewire
lumen size of the catheter 712 are preferably larger than 0.018
inch, at least 0.028 inch, or at least 0.035 inch. The catheter 500
may then be removed and the catheter 712 advanced over the large
stable guidewire. The catheter 500, or another perfusion catheter
described herein, and the catheter 712 and/or guidewire may be
packaged together in a kit for practicing the method as shown in
FIG. 9.
[0111] Referring to FIG. 24, yet another system 740 for treating an
obstruction in the cerebral vasculature is shown. The system 740
includes a first catheter 742 which passes through a second
catheter 743. The first catheter 742 is coupled to the system of
FIGS. 7 or 14 for infusion of fluids in the manner described above.
The second catheter 743 is coupled to a source of inflation fluid
744 for inflating a balloon 745. The system 740 is similar to the
systems described above in that the first catheter 742 infuses the
oxygenated medium while the balloon 745 displaces the obstruction.
The first and second catheters 742, 743 are both tapered with the
first catheter 742 positioned within the second catheter 743 with a
close tolerance fit to reduce the overall size of the system. The
catheters 742, 743 preferably have dimensions of the tapered
catheters described above. Referring to FIGS. 24 and 25, the first
catheter 742 may have a coiled tip 748 similar to a guidewire or
may have a tubular shape similar to a catheter. Referring to FIGS.
26 and 27, the first catheter 742 has a lumen 749 which is coupled
to the system of FIGS. 7 or 14. An inflation lumen 744 may have a
smaller cross-sectional size (FIG. 26) in a deflated position state
relative to an inflated state (FIG. 27).
[0112] Another preferred method of the invention is now described
with reference to FIG. 24. The second catheter 743 is advanced over
a conventional guidewire (not shown) to a position within or near
the obstruction. The guidewire is then removed and the first
catheter 742 is introduced through the second catheter 743. The
first catheter 742 is then advanced through the obstruction
together with the second catheter 743 or by itself. Oxygenated
medium is then delivered in the manner described above. After
infusing the oxygenated medium for the desired time at the desired
rates and pressures, the balloon 745 on the second catheter 743 is
inflated to displace the obstruction. The balloon 745 may also be
used to isolate the ischemic region from normal arterial flow.
[0113] Referring to FIGS. 28-30, an alternative second catheter
743A is shown which may be used in the same manner as second
catheter 743 of FIGS. 24-27. The second catheter 743A has an
expandable sidewall 760 which is folded or wrapped in a collapsed
position and advanced over a guidewire 761 as shown in FIG. 29. The
sidewall 760 provides a small profile when advanced through the
vasculature and a large capacity for use in delivering fluids or
other catheters as described above. The sidewall 760 preferably
reduces the maximum outer dimension of the catheter along a portion
by at least 25% while retaining the overall dimensions of the
catheter 500 when in the expanded configuration. An inflation lumen
752 is coupled to the balloon 745 for inflating the balloon 745.
The sidewall 760 may be made of any suitable material and is
preferably a thermoplastic material having a wall thickness of no
more than 0.38 mm and preferably no more than 0.25 mm. The sidewall
760 may be used with any of the other catheters described herein
and is particularly advantageous for the catheters 10, 400, 500,
600. The sidewall 760 may take other forms without departing from
the scope of the invention.
[0114] The second catheter 743A is advanced over the guidewire 761
with the sidewall 760 in the collapsed condition. When the balloon
745 is positioned proximate to the obstruction, the first catheter
742 is advanced through the catheter 743A. The sidewall 760 is
expanded by the first catheter 742 to the expanded position of FIG.
24. The sheath 760 may also be expanded by an obturator or the like
before introduction of the catheter 742. The first and second
catheters 742, 743A may be then used in any manner described
above.
[0115] The devices 10, 400, 500, 600 described above may be
manufactured in any suitable conventional manner. Although
conventional methods may be used to manufacture the devices
described above, a preferred method of constructing the devices is
now described below in connection with FIGS. 31-34. Referring to
FIG. 31, an exploded view of a preferred construction of an
intravascular device 802 is shown. The intravascular device 802 may
be used in any manner described above and the discussion above is
incorporated here. For example, the device 802 may be used to
deliver oxygenated media to a previously ischemic region or to
deliver other interventional devices. The intravascular device 802
may also be used in other parts of the vascular system without
departing from the scope of the invention.
[0116] The basic construction and method of constructing the device
802 are now described in general terms and more specific details
are given below. A liner 804 is mounted to a mandrel 806. The liner
804 forms the inner lining of a lumen 807 extending through the
device 802. A reinforcing layer 808 is positioned over the liner
804. The reinforcing layer 808 is preferably wound or braided onto
the liner 804 and may be a coil 810 or a woven or braided structure
812. A jacket 814 is then positioned over the reinforcing layer
808. A shrink tube 815 is then positioned over the jacket 814 and
heated to melt and fuse the layers 804, 814 together to form an
integrated structure as shown in FIG. 33. Although the preferred
construction includes only the liner 804, reinforcing layer 808 and
jacket 814, the device 802 may include other layers and may have
coatings, such as a heparin-type or hydrophilic coating, which
cover the inner and/or outer surfaces without departing from the
scope of the invention.
[0117] The mandrel 806 generally defines the interior geometry of
the lumen 807 and preferred dimensions of the lumens described
above are applicable here. The mandrel 806 has a proximal portion
816, an intermediate portion 818, and a distal portion 820. The
distal portion 820 preferably has a constant inner diameter of
0.030-0.050 inch, more preferably 0.040-0.050 inch and most
preferably about 0.046 inch. The distal portion preferably extends
at least 10 cm and more preferably at least 15 cm from a distal end
822. The intermediate portion 818 tapers up from 0.046 to at least
0.070 inch, more preferably at least 0.080 inch and most preferably
about 0.085 inch and extends 30 cm between a first transition 824
and a second transition 826. The proximal portion 816 preferably
has a constant inner diameter of 0.070 to 0.100 inch, more
preferably 0.080 to 0.090 inch and preferably about 0.085 inch for
a length of at least 80 cm and more preferably about 105 cm to a
proximal end 827. Although the lumen 807 has the dimensions
described above for the mandrel 806, the lumen 806 may also be
within the lumen size ranges given above in connection with any of
the embodiments described above.
[0118] The liner 804 has a distal portion 828 which is made of
expanded PTFE and a proximal portion 830 which is made of etched
PTFE. An advantage of using expanded PTFE is that the distal
portion 828 has a flexibility which is greater than with etched
PTFE. Another advantage of the liner 804 is that the two different
PTFE materials provide differing column strength and tip deflection
for the proximal and distal sections 830, 828. The distal portion
828 has the expanded PTFE to provide flexibility to navigate small
and tortuous vessels. The stiffer proximal portion 830 has the
etched PTFE liner which provides pushability and column strength
for advancement of the device 802 through the vascular system. The
distal portion 828 preferably extends 15-25 cm and more preferably
about 21 cm from the distal end 822 but may extend the length of
the device. The proximal portion 830 preferably overlaps the distal
portion 828 for about 0.3 cm with the distal portion 828 positioned
inside the proximal portion 830 to reduce pressure drop at the
transition of the proximal and distal portions 828, 830. A suitable
material for the distal portion 828 of the liner 804 is expanded
PTFE having a wall thickness of 0.002 inch and a diameter of 0.037
inch. The expanded PTFE is stretched onto the mandrel which has a
diameter of 0.046 inch. A suitable material for the proximal
portion 830 of the liner 804 is etched PTFE having a wall thickness
of 0.002 inch and a diameter of 0.093 which is shrunk onto the
mandrel which has a diameter of 0.046-0.085 inch. The etched PTFE
is shrunk onto the mandrel with heat and tension. The expanded PTFE
preferably has an internodal spacing of 10-120 microns, more
preferably 10-60 microns and most preferably about 20-30 microns.
The proximal and distal portions 830, 828 may, of course, both be
made of the same material, such as etched PTFE or expanded PTFE,
without departing from the scope of other aspects of the present
invention.
[0119] The reinforcing layer 808 has a number of sections,
preferably at least four and more preferably at least five
sections, to vary the flexibility along the device 802. The high
variability permits use of the device 802 without a guiding
catheter as described above although a guide catheter may be used
without departing from the scope of the invention. The reinforcing
layer 808 has a first section 832, a second section 834, a third
section 836, a fourth section 838 and a fifth section 840. The
first section 832 is a coil reinforcing element 842 extending along
the distal portion 820 of the mandrel 806 just beyond the
transition 824 to the tapered, intermediate portion 818, preferably
about 19 cm from the distal end 822 and 4 cm beyond the transition
824. The coil 842 is preferably 0.003 inch diameter stainless steel
wire wound to have a centerline spacing .quadrature. of about 0.012
inch. The second, third, fourth and fifth sections 834, 836, 838,
840 are preferably braided 0.003 inch diameter stainless steel
wire. The second, third, fourth and fifth sections 834, 836, 838,
840 are shown separated for clarity but are preferably continuously
wound with the pic being automatically varied during winding. The
second section 834 overlaps the first section for about 1 cm and
begins about 18 cm from the distal end. The second section 834 has
70 pics, the third section 836 has 60 pics, the fourth section 838
has 50 pics and the fifth section 840 has 30 pics. The second
section 834 extends 7 cm, the third section 836 extends 7 cm, the
fourth section 838 extends 7 cm through the transition 826, and the
fifth section extends to the proximal end 827. Although the
reinforcing layer has the specific characteristics described above,
the sections may vary as follows. The second section 834 preferably
has a pic which is at least 15 more, and more preferably at least
20 more, than the fourth section 838. The second section 834 is
preferably separated from the fourth section 838 by no more than 15
cm and preferably no more than 10 cm. The first section preferably
has a pic which is at least 30 pics more than the fifth section 840
with the first section separated from the fifth section by no more
than 20 cm and more preferably no more than 15 cm. Although the
reinforcing layer 808 has the preferred characteristics described
above, the reinforcing layer 808 may be any suitable structure and
may be entirely coil, braid, or weave. The reinforcing layer 808
may also be made of any suitable material such as shape memory
alloy or polymer.
[0120] The jacket 814 preferably includes a number of sections,
preferably at least four, more preferably at least five and most
preferably at least six sections, which also enhance variation in
flexibility. The high variation in flexibility provides good
flexibility at the distal portion while providing column strength
at the proximal portion to advance the device 802 and prevent
kinking. The high variability in the jacket 814 also provides a
smooth transition in stiffness between the distal and proximal
sections. The jacket 814 has first, second, third, fourth, fifth
and sixth liner sections 846, 848, 850, 852, 854, 856 which are
mounted next to one another on the mandrel 806. The flexural
modulus of the jacket preferably increases at least 25, more
preferably at least 40 times, and most preferably about 55 times
from the first section 846 to the sixth section 856. Specifically,
the jacket flexural modulus increases from 2000 psi at the first
section 846 to 110,000 at the sixth section 856. The flexural
modulus of the jacket 814 also increases at least 10 times, more
preferably at least 15 times and most preferably about 17.5 times
over a 10 cm distance from the second section 848 to the fifth
section 854.
[0121] The jacket sections also preferably increases in durometer
towards the proximal end. The durometers of the sections are as
follows; the first section 846 is 25 D, the second section 848 is
35 D, the third section 850 is 40 D, the fourth section 852 is 55
D, the fifth section 854 is 63 D, and the sixth section 856 is 72
D. The sections extend for the following lengths, the first section
846 extends 7 cm from the distal end 822, the second section 848
extends 3 cm, the third section 850 extends 3 cm, the fourth
section 852 extends 3 cm through the transition 824 to the
intermediate portion 818, the fifth section 854 extends 9 cm along
the intermediate portion 818, and the sixth section 856 extends 125
cm. The first, second, third and fourth sections 846, 848, 850, 852
have an inner diameter of 0.080 inch. The fifth section 854, which
extends through the tapered, intermediate section 818, has a
diameter of about 0.095 inch and the sixth section 856 has a
diameter of 0.105 inch. All jackets sections are preferably made of
pellethane, polyurethane or the like. The dimensions may, of
course, be modified without departing from the scope of the
invention.
[0122] As mentioned above, the liner 804, reinforcing elements 808
and jacket 814 are mounted on the mandrel 806. Other layers may be
positioned over the jacket 814 but in the preferred embodiment the
jacket 814 forms the outer layer of the device 802. The shrink tube
815 is positioned over the jacket 814 as shown in FIG. 32 and the
entire structure is heated to form the integrated structure 860 of
FIG. 33. The resulting wall thickness of the device 802 is about
0.005 inch, preferably 0.004 to 0.007 inch, along the distal
portion 820 of the liner 804. The wall thickness of the proximal
portion 816 tapers up from 0.005 inch to 0.015 inch from the end of
the first section of the reinforcing layer to the proximal end.
Although the preferred embodiment provides specific jacket sections
and reinforcement construction, the flexibility of the device may
be provided by other combinations of jacket 814 and reinforcing
layer without departing from the scope of the invention.
[0123] The gradual change in stiffness also provides an advantage
when advancing the catheter through small, tortuous vessels.
Conventional microcatheters must be advanced over a guidewire since
the microcatheters do not have sufficient column strength to be
advanced without the aid of a guidewire. The catheter of the
present invention can be advanced through the vasculature without
the aid of a guidewire although a guidewire may be used when
needed. The change in stiffness helps to resists buckling at the
proximal portion while retaining sufficient flexibility at the
distal portion to navigate small and tortuous vessels. Conventional
microcatheters have low column strength at the distal portion which
requires the micrcatheters to be advanced over a guidewire. The
guidewire generally has an outer diameter within 0.005 inch of the
inner diameter of the lumen so that the guidewire supports the
distal portion to prevent kinking. The distal portion of the
present catheter has sufficient column strength to be advanced
without a guidewire.
[0124] In a specific application of the present invention, the
catheter is advanced to the common carotid artery over a
conventional guidewire such as an 0.035 inch diameter guidewire.
The distal portion is then advanced without the aid of a guidewire
into intracranial vessels having a size of 4-5 mm and even 3 mm in
diameter. Stated another way, the catheter of the present invention
may be used to access vessels such as the middle or anterior
cerebral arteries and the vertebral, basilar and posterior cerebral
arteries when accessing the cerebral vasculature.
[0125] The catheter of the present invention also has a high change
in flexibility from a proximal portion to a distal portion.
Specifically, the proximal section is at least 20, 40, 60 or even
75 times stiffer than the distal portion of the catheter. The
distal portion preferably extends at least 5, more preferably at
least 10, and more preferably at least 15 cm from the distal end
while the proximal portion extends to within 40, 35 and most
preferably to within 30 cm from the distal end or closer. The high
change in stiffness permits the proximal portion to be rigid enough
to prevent buckling and kinking while the distal portion is
flexible to pass through tortuous vessels.
[0126] Referring to FIG. 34, the distal end 822 of the device is
shown with the distal portion 828 of the liner 804 extending beyond
the reinforcing layer 808 and the jacket 814 after heating to form
the integrated structure. The end of the liner 804 is everted to
form a soft, atraumatic distal end. The end of the liner 804 is
everted for a length .quadrature. of at least 0.5 mm, more
preferably 1-2 mm, and preferably 2 mm to form the soft tip. Use of
the expanded PTFE material for the distal portion 828 provides a
soft tip which helps to navigate the device through small and
tortuous vessels. The proximal end is then attached to the
necessary connectors and hemostasis valves so that the device 802
forms all or part of the intravascular device such as the devices
10, 400, 500, 600 described above. The device 802 may, of course,
be used for other procedures and in other parts of the body.
[0127] Referring to FIGS. 31, 35 and 36, another device 802A is
shown which has the lumen 807 and an additional lumen 860 wherein
the same or similar reference numbers refer to the same or similar
structure. FIG. 35 shows a cross-sectional view along the distal
portion and FIG. 36 is a cross-sectional view of the device 802A
along the proximal portion. The device 802A is constructed in
substantially the same manner as the device 802 and the discussion
above is equally applicable here. The lumen 860 is formed by a tube
862 which is essentially bonded to the device 802 in the manner
described below. The lumen 860 preferably has a cross-sectional
area of 0.050 to 0.620 mm2 and more preferably 0.200 to 0.400
mm2.
[0128] The tube 862 is preferably a polyimide tube having an inner
diameter of 0.020-0.035 inch, preferably about 0.026 inch, with a
wall thickness of 0.001 to 0.002 inch. Of course, any other
suitable material and size may be used. The tube 862 has a length
of about 134 cm with an opening 864 positioned 5-26 cm, more
preferably 10-26 cm, and most preferably about 18 cm from the
distal end of the device 802A. The opening 864 may also be closer
to the distal end without departing from the scope of the
invention. The opening 864 is preferably positioned along the
tapered portion of the device 802A but may also be at the constant
diameter distal portion. The opening 864 is shown formed in the
tube 862 in FIG. 31 for clarity, however, the opening 864 is
preferably formed after forming the integrated structure of FIGS.
35 and 36 as described below.
[0129] The tube 862 is preferably rolled through a die to create an
oblong cross-sectional shape. The tube 862 is then positioned over
the jacket 814 and is covered by the shrink tube as described
above. The jacket 814 is positioned over the reinforcing layer 808
and liner 804 in the manner described above. The tube 862 is
preferably coated with a polymer, such as polyurethane having a
thickness of 0.002-0.003 inch, which fuses with the jacket 814 when
melted. The tube 862 may melt and fuse with the jacket 814 or may
be designed to remain solid during heating as shown in FIGS. 35 and
36. The end of the tube 862 is crimped to close the distal end and
the opening 864 is formed after forming the integrated structure of
FIG. 35. A teflon-coated mandrel may be positioned in the tube 862
to hold the tube 862 open during heating and melting.
[0130] The device 802A may be used in any manner described above
and the discussion above is equally applicable here. Furthermore,
the device 860A may have the features of the other multi-lumen
devices described herein and the discussion of the various
dimensions and preferred uses described herein are also applicable
here. For example, the device 802A may be used to deliver an
oxygenated medium to a previously ischemic region in the manner
described above. The lumen 860 may be used to deliver thrombolytic,
anticoagulant and/or anti-restenotic agents. The lumen 860 may also
be used to deliver contrast or to measure pressure.
[0131] While the above is a complete description of the preferred
embodiments, various alternatives, modifications, and equivalents
may be used. The terms first liner, second liner . . . or first
portion, second portion are used for ease of reference in the
drawings and figures, however, these terms may refer to other
sections or portions without departing from the scope of the
invention. Thus, when the claims recite that a first liner section
has a preferred durometer change with respect to a third liner
section, the first and third sections in the claims may actually
refer to a second and fourth liner sections or to fourth and sixth
liner sections without departing from the scope of the claims.
Therefore, the above description should not be taken as limiting
the scope of the invention which is defined by the appended
claims.
* * * * *