U.S. patent application number 12/593226 was filed with the patent office on 2010-05-06 for spiral balloon catheter.
Invention is credited to Eran Hirszowicz, Hila Yaron.
Application Number | 20100114022 12/593226 |
Document ID | / |
Family ID | 39789110 |
Filed Date | 2010-05-06 |
United States Patent
Application |
20100114022 |
Kind Code |
A1 |
Hirszowicz; Eran ; et
al. |
May 6, 2010 |
SPIRAL BALLOON CATHETER
Abstract
The present invention provides a balloon catheter system
comprising one or more conduits to which are attached a compliant
balloon having a non-helical shape in its deflated state, wherein
said balloon is constructed such that is capable of adopting a
spiral or helical conformation upon inflation. In addition, the
present invention also provides methods for using said balloon
catheter system.
Inventors: |
Hirszowicz; Eran; (Ramat
Gan, IL) ; Yaron; Hila; (Tel Aviv, IL) |
Correspondence
Address: |
PATTON BOGGS LLP
8484 WESTPARK DRIVE, SUITE 900
MCLEAN
VA
22102
US
|
Family ID: |
39789110 |
Appl. No.: |
12/593226 |
Filed: |
March 27, 2008 |
PCT Filed: |
March 27, 2008 |
PCT NO: |
PCT/IB08/51158 |
371 Date: |
January 15, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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60920145 |
Mar 27, 2007 |
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60978122 |
Oct 7, 2007 |
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61038795 |
Mar 24, 2008 |
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Current U.S.
Class: |
604/103.07 |
Current CPC
Class: |
A61M 25/1006 20130101;
A61M 2025/1013 20130101; A61M 25/1011 20130101; A61M 29/02
20130101; A61M 25/1002 20130101; A61M 2025/109 20130101 |
Class at
Publication: |
604/103.07 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. A balloon catheter system comprising one or more conduits to
which is/are attached a compliant balloon having a non-helical
shape in its deflated state, wherein said balloon is constructed
such that is capable of adopting a spiral or helical conformation
upon inflation.
2. The balloon catheter system according to claim 1, wherein the
relative values of the length of the balloon in the deflated state,
the elongation fraction and the inner diameter of said balloon in
the deflated state are chosen, such that said balloon is capable of
adopting a spiral or helical conformation upon inflation.
3. The balloon catheter system according to claim 1, wherein the
balloon is attached to a single catheter conduit.
4. The balloon catheter system according to claim 1, wherein the
distal neck of the balloon is attached to one catheter conduit
while the proximal neck thereof is attached to a second conduit,
wherein said first and second conduits are arranged such that at
least a portion of the shaft of one of the conduits is disposed
within the lumen of the other conduit.
5. The balloon catheter system according to claim 4, further
comprising at least one side aperture that connects the lumen of
the inner conduit with the space surrounding the outer conduit.
6. The balloon catheter system according to claim 1, further
comprising an aspiration tube, the distal end of which is located
close to, and on the proximal side of, the proximal neck of the
balloon.
7. A method for removing particulate matter from a body passage in
a patient in need of such treatment, comprising the steps of: a)
providing a catheter fitted with a compliant balloon and an
aspiration element, wherein said balloon is constructed such that
it has a non-spiral shape when deflated and adopts a spiral
conformation when inflated; b) introducing said catheter into a
peripheral blood vessel and advancing same until said balloon is
located in the region of the particulate matter to be removed; c)
inflating said balloon such that it adopts a spiral conformation,
thereby causing said particulate matter to enter said spiral
channel thus formed in the external surface of the balloon, and to
becomes squeezed and elongated between said balloon and said blood
vessel wall; d) aspirating said squeezed particulate matter into
said aspiration element, wherein said aspiration may be performed
continuously or intermittently; e) optionally partially or
completely deflating the balloon and re-locating the catheter such
that said balloon becomes located in another region of particulate
matter to be removed, and repeating steps (c) and (d); f)
completely deflating the balloon and withdrawing the catheter from
the patient's vasculature.
8. The method according to claim 7, wherein the particulate matter
to be removed is thrombotic material.
9. A method for removing thrombotic material from a body passage in
a patient in need of such treatment, comprising the steps of: a)
providing a catheter fitted with a compliant balloon, as disclosed
hereinabove, wherein said balloon is constructed such that it has a
non-spiral shape when deflated and adopts a spiral conformation
when inflated; b) introducing said catheter into a peripheral blood
vessel and advancing same until said balloon is located in the
region of the thrombotic material to be removed; c) inflating said
balloon such that it adopts a spiral conformation having a spiral
channel winding around the external surface of said balloon,
thereby causing said thrombotic material to enter said spiral
channel and to becomes squeezed and elongated between said balloon
and said blood vessel wall; d) deflating said balloon, thereby
creating a space between the deflated balloon and the squeezed
thrombotic material, into which a thrombolytic agent may be
introduced, thereby enhancing thrombo-dissolution; e) rapidly
repeating steps (c) and (d); and f) completely deflating the
balloon and withdrawing the catheter from the patient's
vasculature.
10. A method for removing a thrombus from a body passage in a
patient in need of such treatment, comprising the steps of: a)
providing a catheter fitted with a compliant balloon, as disclosed
hereinabove, wherein said balloon is constructed such that it has a
non-spiral shape when deflated and adopts a spiral conformation
when inflated; b) introducing said catheter into a peripheral blood
vessel and advancing same until said balloon is located in the
region of the thrombus to be removed; c) trapping the thrombus
within the spiral channel formed by inflation of the balloon d)
withdrawing the catheter through the vasculature and out of the
body, together with said entrapped thrombus.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a balloon catheter device
for use inside blood vessels and other body passages. More
specifically, the presently-disclosed invention is a catheter
device comprising a balloon that is capable of adopting a spiral
conformation upon inflation.
BACKGROUND OF THE INVENTION
[0002] Balloon catheters have, over the course of the last few
decades, found use in the diagnosis and treatment of many medical
conditions. While different versions of these devices have been
designed and constructed for use in many different body
passages--such as the urinary tract, uterus and fallopian tubes and
gastrointestinal tract--the intravascular use of balloon catheters
is arguably their fastest-growing field of application. Thus,
balloon catheters have been used in various angioplasty procedures,
stent implantation, thrombus-crossing, embolic protection, and so
on.
[0003] The inappropriate and undesirable formation of blood clots
intravascularly may have severe pathological consequences, as a
consequence of the disturbance of blood flow to vital organs and
tissues such as the heart muscle and brain. In extreme cases, total
occlusion of the afferent arteries may lead to ischemic damage
which, in the case of the heart, may manifest itself clinically in
the form of myocardial infarction. Similarly, the local production
of thrombi in the cerebral vessels or the deposition therein of
thrombotic emboli may lead to cerebral infarcts. In both cases,
serious morbidity and death are common consequences. It has been
estimated, for example, that emboli arising from atherosclerotic
plaques of the carotid artery cause approximately one quarter of
the 500,000 strokes that are recorded annually in the United
States.
[0004] Several different medical and surgical approaches aimed at
removing thrombotic and embolic material from blood vessels have
been proposed and attempted. One such approach requires the
injection of thrombolytic agents. Alternatively or additionally, a
variety of balloon catheter systems have been used to both expand
blood vessels that have become narrowed due to thrombus formation
or deposition and, in some cases to collect detached thrombotic
material and remove same from the body.
[0005] One example of a balloon catheter system that has been
designed for use in removing thrombotic material and other
intravascular particulate matter from the body is that disclosed in
U.S. Pat. No. 4,762,130 (Fogarty). While several different
embodiments of the catheter are described in the patent, a feature
common to all of these embodiments is that a balloon is advanced
into the region of the thrombus to be treated and then expanded
into a helical or spiral configuration, thereby engaging said
thrombus within the spiral channels of the inflated balloon. The
spiral balloon is then withdrawn from the body with the thrombus
still attached thereto. A particular disadvantage of this prior art
system is that the catheter is usually inflated distally to the
thrombus (or other particulate matter) and is then pulled back in
order to facilitate collection of the thrombotic material by the
balloon. This procedure can be traumatic for the blood vessel.
Furthermore the balloon does not always completely seal the vessel
and some of the debris escapes into the blood stream and is not
removed.
[0006] A further key problem associated with the aforementioned
prior art system is the fact that during balloon inflation, the
blood flow through the vessel is blocked. Indeed, in many balloon
catheter systems, the volume taken up by the balloon when inflated
is problematic. In addition, many existing catheter balloons, even
when in their deflated state present an unacceptably large
cross-sectional profile, thereby causing problems in the insertion
and maneuvering of the catheter within the vasculature.
[0007] It is a purpose of the present invention to provide a novel
balloon catheter system that presents both a small cross-sectional
profile when the balloon is deflated, and which allows blood flow
therearound, even when the balloon is fully inflated.
[0008] It is a further purpose of the invention to provide a system
that may be used for trapping and retaining particulate matter and
safely removing said matter from the body.
[0009] It is a still further purpose of the invention to provide a
balloon catheter system that overcomes the problems and
disadvantages associated with prior art devices.
[0010] Further objects and advantages of the present invention will
become apparent as the description proceeds.
SUMMARY OF THE INVENTION
[0011] The present inventors have unexpectedly discovered that
compliant tubes (i.e. balloons or sheaths) that fulfill certain
dimensional criteria may be caused to adopt a spiral or helical
conformation when expanded. In contradistinction to certain prior
art balloons, the compliant tubes of the present invention are able
to adopt spiral conformations upon inflation without the need for
any additional structural features such as external restraining
bands or intraluminal spiral-forming wires. In other words, the
balloons of the present invention have an intrinsic ability to
adopt a spiral shape upon inflation, said ability being a function
of the materials used in the construction of the balloon, the
dimensions of the balloon, and the attachment of the balloon at
each of its ends to a catheter shaft. This novel form of compliant
balloon has significant advantages in relation to prior art
balloons, in terms of possessing both an extremely low cross
sectional profile when deflated, and a helical or spiral shape when
inflated.
[0012] The present invention, in its most general form, is a
balloon catheter device comprising a tubular compliant balloon that
is attached at its distal and proximal extremities to a catheter
tube. Upon inflation, the balloon, which is incapable of any
significant elongation in a proximal-distal direction (due to its
terminal attachment to the catheter shaft), adopts a spiral or
helical conformation. It is to be emphasized that in its deflated
state, the balloon appears as a conventional, low profile, linear
(i.e. non-spiral) sheath surrounding the conduit to which it is
attached. It is only during inflation that this linear sheath
adopts a spiral conformation.
[0013] The present invention is therefore primarily directed to a
balloon catheter system comprising one or more conduits to which
is/are attached a compliant balloon having a non-helical shape in
its deflated state, wherein said balloon is constructed such that
upon inflation, it is capable of adopting a spiral or helical
conformation, and wherein said balloon does not require the use of
any ancillary structures such as wires, bands or formers in order
to adopt said helical shape upon inflation.
[0014] For the purposes of the present disclosure, the terms
"proximal" and "distal" are defined from the physician's (or other
operator's) perspective. Thus, the term "proximal" is used to refer
to the side or end of a device or portion thereof that is closest
to the external body wall and/or the operator, while the term
"distal" refers to the side or end of a structure that is in an
opposite direction to the external body wall and/or operator.
[0015] In one preferred embodiment the distal and proximal necks of
the balloon are attached to a single catheter conduit. In another
preferred embodiment, the distal neck of the balloon is attached to
one catheter conduit while the proximal neck thereof is attached to
a second conduit, wherein said first and second conduits are
arranged such that at least a portion of the shaft of one of the
conduits is disposed within the lumen of the other conduit.
[0016] In another preferred embodiment, the balloon catheter system
further comprises an aspiration element. The general form of this
element is a low-profile suction tube, the proximal end of which is
connected to a negative pressure source, and the open distal end of
which is located close to the proximal neck of the balloon.
Preferably, the aspiration element is bound to the catheter
conduit.
[0017] In another aspect, the present invention is directed to a
method for removing particulate matter from a body passage in a
patient in need of such treatment, comprising the steps of: [0018]
a) providing a catheter fitted with a compliant balloon and an
aspiration element, as disclosed hereinabove, wherein said balloon
is constructed such that it has a non-spiral shape when deflated
and adopts a spiral conformation when inflated; [0019] b)
introducing said catheter into a peripheral blood vessel and
advancing same until said balloon is located in the region of the
particulate matter to be removed; [0020] c) inflating said balloon
such that it adopts a spiral conformation having a spiral channel
winding around the external surface of said balloon, thereby
causing said particulate matter to enter said spiral channel and to
becomes squeezed and elongated between said balloon and said blood
vessel wall; [0021] d) aspirating said squeezed particulate matter
into said aspiration element, wherein said aspiration may be
performed continuously or intermittently; [0022] e) optionally
partially or completely deflating the balloon and re-locating the
catheter such that said balloon becomes located in another region
of particulate matter to be removed, and repeating steps (c) and
(d); [0023] f) completely deflating the balloon and withdrawing the
catheter from the patient's vasculature.
[0024] In one preferred embodiment of this method, the particulate
matter to be removed is thrombotic or embolic in origin.
[0025] The present invention also provides a method for removing
thrombotic material from a body passage in a patient in need of
such treatment, comprising the steps of: [0026] a) providing a
catheter fitted with a compliant balloon, as disclosed hereinabove,
wherein said balloon is constructed such that it has a non-spiral
shape when deflated and adopts a spiral conformation when inflated;
[0027] b) introducing said catheter into a peripheral blood vessel
and advancing same until said balloon is located in the region of
the thrombotic material to be removed; [0028] c) inflating said
balloon such that it adopts a spiral conformation having a spiral
channel winding around the external surface of said balloon,
thereby causing said thrombotic material to enter said spiral
channel and to becomes squeezed and elongated between said balloon
and said blood vessel wall; [0029] d) deflating said balloon,
thereby creating a space between the deflated balloon and the
squeezed thrombotic material, into which a thrombolytic agent may
be introduced, thereby enhancing thrombo-dissolution; [0030] e)
rapidly repeating steps (c) and (d); and [0031] f) completely
deflating the balloon and withdrawing the catheter from the
patient's vasculature.
[0032] The present invention further provides a method for removing
a thrombus from a body passage in a patient in need of such
treatment, comprising the steps of: [0033] a) providing a catheter
fitted with a compliant balloon, as disclosed hereinabove, wherein
said balloon is constructed such that it has a non-spiral shape
when deflated and adopts a spiral conformation when inflated;
[0034] b) introducing said catheter into a peripheral blood vessel
and advancing same until said balloon is located in the region of
the thrombus to be removed; [0035] c) trapping the thrombus within
the spiral channel formed by inflation of the balloon [0036] d)
withdrawing the catheter through the vasculature and out of the
body, together with said entrapped thrombus.
[0037] All the above and other characteristics and advantages of
the present invention will be further understood from the following
illustrative and non-limitative examples of preferred embodiments
thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] FIG. 1 depicts the balloon catheter of the present invention
with the compliant balloon in its collapsed, deflated state.
[0039] FIG. 2 illustrates the catheter of the present invention
following inflation of the balloon.
[0040] FIG. 3 illustrates one preferred embodiment of the balloon
catheter of the present invention having an aspiration element that
ends on the proximal side of the balloon (shown inflated).
[0041] FIG. 4 is a schematic longitudinal section view of a balloon
catheter of the present invention in its deflated state, in which
various critical balloon design parameters are defined.
[0042] FIG. 5 is a schematic longitudinal section view of a balloon
catheter of the present invention in its inflated state, in which
various critical balloon design parameters are defined.
[0043] FIG. 6 shows a longitudinal section of a spiral-forming
balloon (deflated) mounted on a single-lumen stainless steel
tube.
[0044] FIG. 7 shows a longitudinal section of a spiral-forming
balloon (deflated) mounted on a guidewire state having a sliced
distal portion.
[0045] FIG. 8 depicts a longitudinal section of a spiral-forming
balloon (deflated) having a stainless steel wire welded to the
distal end of a stainless steel conduit.
[0046] FIG. 9 depicts a longitudinal section of a spiral-forming
balloon (deflated) featuring a side-hole for the injection of
contrast agents, thrombolytic agents or other fluids.
[0047] FIG. 10 shows a longitudinal section of an embodiment of the
present invention in which a specially-designed guidewire is used
to block the distal catheter exit.
[0048] FIG. 11 shows a longitudinal section of an alternative
embodiment of the device of the present invention, in which the
inner catheter lumen has a narrowed distal end, thereby allowing
the distal catheter exit to be blocked by a standard guidewire.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0049] The invention is based on the use of a compliant balloon
which is fitted over a catheter conduit in a conventional (i.e.
non-spiral) and manner, the distal and proximal ends of said
balloon being attached to said conduit.
[0050] In its deflated state (FIG. 1), the balloon is in the form
of a tube of compliant material with a diameter, in one preferred
embodiment, of up to 1/15 of the final crossing profile of the
inflated balloon. The tube can be constructed with a uniform wall
thickness or with a wall thickness which varies along its length.
The collapsed balloon is indicated in FIG. 1 by part number 12
attached to catheter shaft 10.
[0051] The balloon can be made from one material. Alternatively, it
may be constructed from two or more different materials, thereby
producing a non-uniform spiral balloon upon inflation. Suitable
materials for use in constructing the compliant balloon include
(but are not limited to): silicones and thermoplastic elastomers
(TPEs) such as (but not limited to) Evoperene and Monoprene. The
balloon may be manufactured from these materials using standard
balloon production techniques well known to the skilled artisan in
this field.
[0052] The balloon 12 is bound at two points to a rigid or
semi-rigid conduit 10 which is threaded through the balloon. Since
the balloon is made of a compliant material it elongates during
inflation. The attachment of the balloon to the catheter conduit
may be achieved using any of the standard bonding techniques and
materials well known in the art, for example adhesion using
biocompatible glues such as silicone glue.
[0053] Since the balloon 12 is bound at both its ends, its
longitudinal elongation is restrained. Provided certain
balloon-related design parameter criteria are met (as will be
discussed hereinbelow), said balloon 12 will then buckle and assume
a spiral shape as shown in FIGS. 2 and 3.
[0054] FIG. 3 illustrates a preferred embodiment of the balloon
catheter which further comprises an aspiration element 14. The
general form of this element is a low-profile suction tube, the
proximal end of which is connected to a negative pressure source,
and the open distal end of which is located close to the proximal
neck of the balloon. In one embodiment, the aspiration element is
bound to the catheter conduit by means of loops, ties or any other
suitable method. Alternatively, the aspiration element may be
unattached to the catheter conduit. The aspiration tube may be made
from any suitable biocompatible material such as (but not limited
to) Pebax and Nylon. Typically, the aspiration tube may have an
external diameter of 6 Fr and an internal diameter of 0.070''.
However, it is also possible to use larger or smaller tubes to
achieve the same result, and without deviating from the scope of
the present invention.
[0055] Typical aspiration pressures are in the order of 640 to 680
mmHg, and may be provided by standard negative pressure sources
such as are available in hospitals and other health-care
centers.
[0056] FIG. 3 also illustrates that when compliant balloon 12 is
inflated, a spiral channel 16 is formed. The presence of this
channel is advantageous for at least two reasons. Firstly, the
presence of the open channel prevents occlusion of the blood vessel
when the balloon is fully inflated. Secondly, in some embodiments
of the invention, the spiral channel may be used for the capture
and removal of particulate matter (e.g. thrombotic material) from
the blood vessel.
[0057] The embodiment of the device illustrated in FIG. 3 is
capable of removal of a large thrombus from vessels using a low
profile catheter that can be introduced into the body using a 5-Fr
introducer. In general terms, thrombus removal is achieved by
altering the thrombus shape (e.g. by causing elongation and
flattening thereof) so that it can be easily aspirated through the
low profile aspiration tube and thereby removed from the body. A
method for removing particulate matter from body passages (for
example--thrombus material from blood vessels) will be described in
more detail hereinbelow.
[0058] It has been unexpectedly found by the present inventors that
certain fundamental conditions need to exist in order for the
compliant balloon of the present invention to adopt a spiral or
helical shape when inflated. These may be summarized as follows:
[0059] 1. For a specific balloon dimension the balloon material
should have a minimum value of elongation (E). [0060] 2. For a
given specific balloon dimension and a specific elongation of the
material a minimum initial length of tube (L.sub.0) is necessary.
[0061] 3. The compliant balloon tube should be assembled on a rigid
or semi-rigid core shaft that withstands the longitudinal spiral
forces. Otherwise the core shaft will elongate and the spiral
balloon will become a spherical balloon. [0062] 4. The balloon tube
should be attached at both ends to the rigid core shaft so that its
longitudinal elongation is restricted. [0063] 5. Minimum radial
uniformity of the wall thickness of the balloon tube is necessary
to form a spiral balloon. [0064] 6. Minimum homogeneity of the
balloon material is necessary to form a spiral balloon. [0065] 7.
The space between the outer surface of the shaft and the inner wall
of the compliant tube ("t") should allow relative movement of the
compliant tube over the core shaft during inflation. If the space
is too small or non-existent, the friction between the balloon and
the shaft does not allow an even elongation of the tube and the
formation of a spiral shape.
[0066] The critical balloon and catheter tube parameters (including
those mentioned above), are defined in FIG. 4 (deflated state) and
FIG. 5 (inflated state), and in the following list: [0067] Spiral
Arc is the guideline of the inflated spiral balloon which is
measured along the center line of the inflated balloon [0068]
Spiral Cord is the straight line going from the start point to the
end point of the spiral arc [0069] E is the elongation fraction of
the balloon upon inflation (depends on the material elasticity)
[0070] L.sub.0 is the length of the balloon in its deflated state
[0071] L.sub.f is the length of the inflated balloon if allowed to
inflate longitudinally, equals L.sub.0(1+E) [0072] D.sub.0 is the
inner diameter of the deflated balloon [0073] OD.sub.0 is the outer
diameter of the deflated balloon [0074] D.sub.f is the diameter of
the inflated tube, equals D.sub.0(1+E) [0075] OD.sub.f is the
diameter of the inflated spiral balloon [0076] N is the number of
threads of the spiral balloon [0077] 2.pi.C is the vertical
separation of the spiral threads (pitch) [0078] r.sub.spiral is the
radius of the spiral arc of the inflated balloon [0079]
L.sub.spiral is the length of the spiral arc of the inflated
balloon
[0080] Only when the conditions defined above are met will a
non-spiral compliant balloon adopt a spiral conformation upon
inflation. Following extensive investigations of the relevant
parameters, the inventors have succeeded in defining the conditions
for spiral formation of the balloons of the present invention in
formal terms. This formal definition may be summarized in the
following expression:
N = L 0 2 .PI. 2 D 0 2 - L 0 2 .PI. 2 D 0 2 ( 1 + E ) 2 = L 0 2 E (
2 + E ) .PI. 2 D 0 2 ( 1 + E ) 2 .gtoreq. 2 ##EQU00001##
[0081] Clearly, N (the number of spiral threads) needs to have a
value of at least two in order for a spiral structure to be formed
upon inflation. Thus, in accordance with this formal definition, in
order for a compliant balloon of the present invention (bound at
both of its ends to a rigid catheter shaft) to adopt a spiral
conformation upon inflation, it is necessary for the relative
values of Lo, E and Do (all as defined above) to be such that N has
a value of at least two.
[0082] Examples of various compliant tubular balloons and their
ability to adopt a spiral conformation are summarized in the
Example provided hereinbelow.
[0083] Using different wall thicknesses or different materials the
shape of the helix and the inflation sequence can be controlled. In
one preferred embodiment, for example, it has been found that a
compliant balloon having a length of 30 mm, an outer diameter of 1
mm and a wall thickness of 0.25 mm readily adopts a spiral
conformation upon inflation, provided that both ends of said
balloon are bound to a rigid conduit.
[0084] Typically, the compliant balloon will have a length in the
range of 15 mm to 50 mm and a wall thickness in the range of 100
micron to 400 micron. It should be emphasized that the preceding
dimensions (and all other dimensions that appear herein) are
exemplary values only, and should not be construed as limiting the
size of the presently-disclosed device in any way.
[0085] The general embodiment of the balloon catheter of the
present invention that is described hereinabove and depicted in
FIGS. 1 to 3 comprises a single catheter conduit to which the
compliant balloon is attached. However, it is to be recognized that
many other catheter conduit conformations may also be used in the
present invention. For example, instead of the single-conduit
system, the device of the present invention may have a two-conduit
conformation, with (for example) the proximal neck of the balloon
being attached to the outer surface of an outer conduit, while the
distal neck thereof is attached to the outer surface of an inner
conduit that is disposed within the lumen of said outer conduit. In
this type of conformation, the inner conduit will generally extend
beyond the distal end of the outer conduit. The device of the
present invention may also comprise one or more conduits having
multiple lumens (e.g. bi-lumen catheters) where the additional
lumens may be used for a variety of purposes, including the passage
of guidewires, instrumentation or tools.
[0086] In addition, various catheter tubes having a particularly
small cross-sectional profile may be used to mount the
spiral-forming balloon of the present invention. In one preferred
embodiment of this type of device, the catheter is constructed of a
single-lumen stainless steel tube with a distally assembled spiral
balloon (FIG. 6). The deflated cross profile ranges between 0.4 and
0.8 mm. The tube may be delivered to the target through a 2.4 Fr or
3.8 Fr microcatheter. The catheter tube 18 can have a laser cut
(spiral cut or grooves) at its distal section or all along its
length to increase its flexibility. In order to maintain the
integrity of the lumen, a thin (approximately 0.0005'') polymeric
jacket 19 (for example, PET or PTFE) is applied over the tube (e.g.
by a heat-shrink process). An aperture 26 is created at the distal
section of the hypotube for the inflation of the spiral balloon.
The distal end of the hypotube 28 is plugged by using a plasma weld
process, laser weld process or adhesive process. The compliant
balloon 24 is shown in this figure and in the figures that follow
in its deflated state.
[0087] The aforementioned spiral-forming balloon 24 is attached at
its ends to the distal portion of the hypotube (in a non-spiral,
conventional manner) by means of thermo-bonding or adhesive
technology.
[0088] In a variant of this embodiment, shown in FIG. 7, a reduced
cross-section profile of the distal portion of the hypotube 20
(i.e. in the region of the balloon attachment) is obtained by
longitudinally slicing said portion, thereby creating a reduced
diameter tube region 22 of approximately semi-circular cross
sectional form.
[0089] In a further reduced cross-section variant, shown in FIG. 8,
a stainless steel wire 30 having a diameter of, for example, 0.2 mm
may be welded to the distal end of the tube 20. As a result of this
modification, a balloon 24 with a smaller ID may be used, thereby
leading to a distal section having a significantly smaller cross
section profile.
[0090] In another preferred embodiment of the invention, the
catheter may be delivered (in either over-the-wire or rapid
exchange mode) over a coronary 0.014'' guidewire (FIG. 9). The
minimum cross sectional profile of the catheter may be in the order
of 0.8-1.0 mm. The balloon 24 depicted in the longitudinal section
shown in FIG. 9 is mounted in a conventional manner on a
two-conduit coaxial design catheter similar to standard balloon
catheters known in art, with the proximal end of the balloon 24
being attached to the outer tube 34 and the distal end thereof
being attached to the inner tube 32. Both the inner tube and the
outer tube may be constructed by the use of extrusion techniques
from materials commonly used in the art including Nylon, Pebax, PET
and Polyurethane. The balloon 24 is inflated in a conventional
manner well known to skilled artisans in the field, through an
inflation lumen formed by the space between the inner and outer
tubes.
[0091] In most over-the-wire catheters, the lumen of the inner
conduit functions primarily as a guidewire lumen. However, in the
embodiments illustrated in FIGS. 9 to 11, the presence of one or
more side exits (or apertures) 38 proximal to the balloon that
communicate between said guidewire lumen 36 and the area
surrounding the outer tube permit said lumen to be additionally
used for the delivery of liquid substances of various types to the
region of the blood vessel that is in proximity to said exit(s).
Thus, in one preferred embodiment, after the balloon is delivered
to the target and the guidewire withdrawn, the guidewire lumen may
used for injecting liquids (including, but not limited to standard
contrast media and thrombolytic agents, such as tPA) through both
the side exit and distal exit of the lumen. In other preferred
embodiments, fluid injection takes place while the guidewire is
still indwelling.
[0092] The aforementioned side aperture 38 will generally be sized
such that its surface area will be approximately equal to the
cross-sectional area of the inner tube lumen. The aperture is
formed by means of a laser cut, and the side walls of said aperture
are sealed by thermo-bonding methods, in order to prevent seepage
between the inner and outer tubes.
[0093] In the case of injection of thrombolytic agents through the
catheter it is of utmost importance to avoid injecting said agents
on the distal side of the balloon. In order to prevent this
occurrence, the distal opening of the catheter needs to be capable
of being blocked, while the side exit remains open. Moreover,
injection of thrombolytic agents proximal to the balloon, and in
the vicinity of the thrombus (by the aforementioned means of
blocking the distal opening while retaining the side aperture open)
beneficially enhances the dissolution of the thrombus. While
several different technical solutions may be employed in order to
achieve closure of the distal opening, while retaining an open side
aperture, the following designs represent particularly preferred
embodiments: [0094] i. FIG. 10 illustrates the use of a
specially-designed graded guidewire 40 having a wider distal end
that is used to block the distal exit 42, thus permitting flow
through the proximal exit 38 only. The upper part of FIG. 10
illustrates this embodiment with the distal exit 42 blocked, while
the lower part of the figure shows said exit in the open position.
[0095] ii. FIG. 11 shows the use of a specially-modified catheter
inner lumen which has a narrowed distal exit 42 so that a standard
0.014'' guidewire 44 can block the distal exit, allowing flow
through the proximal exit 38 only. When the guidewire is retrieved
about 10 cm backward, flow is possible through both the side exit
38 and the distal exit 42. The upper part of FIG. 11 illustrates
this embodiment with the distal exit 42 blocked, while the lower
part of the figure shows said exit in the open position.
[0096] The conduits used to construct the catheter device of the
present invention may be made of any suitable material including
(but not limited to) a biocompatible polymer such as polyurethane
or nylon or PET, or a biocompatible metal such as stainless steel,
and may be manufactured utilizing conventional methods, such as
extrusion and laser cutting. The diameter of the conduits is
generally in the range of 0.5-2.0 mm, and their length is generally
in the range of 100-2000 mm.
[0097] The compliant balloon may be inflated by introducing a
pressurized inflation media via an inflation fluid port that is in
fluid connection with a source of pressurized media and a pumping
device or syringe. In the case of a single conduit catheter, the
inflation media passes through openings in the wall of the catheter
shaft located between the proximal and distal attachment points of
the balloon. In the case of a dual (inner-outer) conduit
conformation, as described above, the inflation media passes via an
inflation fluid lumen formed between the inner wall of the outer
conduit and the outer surface of the inner conduit.
[0098] In another embodiment, the balloon of the present invention
may be assembled onto a two-conduit catheter, wherein the inner
conduit is movable in relation to the outer conduit. In this way,
the cross-sectional profile of the non-inflated balloon may be
reduced even further by means of moving the inner tube distally
prior to insertion of the catheter into the vasculature, thereby
stretching the balloon and thus reducing its wall thickness.
Typical Procedure for Using a Balloon Catheter of the Present
Invention (Fitted with an Aspiration Tube) to Remove Thrombotic
Material from a Blood Vessel: [0099] 1. The catheter is advanced
through the target blood vessel until the balloon is brought close
to the region of the thrombotic material that is to be removed.
[0100] 2. The balloon is inflated, a spiral channel thereby being
formed between the outer surface of balloon (which has now adopted
a spiral or helical form) and the blood vessel wall. This channel
fills with particulate thrombotic matter, which becomes compressed
and elongated as a result of the pressure exerted by the expanded
balloon on the blood vessel wall. [0101] 3. A negative pressure
source is connected to the proximal end of the aspiration tube, and
the compressed, elongated thrombotic material is thereby aspirated
into said tube. [0102] 4. The balloon may then optionally be
partially or completely deflated and moved into proximity with a
further aspiration target, and steps 2 and 3 repeated. [0103] 5.
When the clinical need is met, the spiral balloon is completely
deflated and retrieved from the body.
[0104] The pressure in the balloon when fully inflated with an
expansion medium such as saline or a contrast medium is in the
range of 0.5-4 atmospheres, and often in the range of 1.5-2
atmospheres.
[0105] It is, of course, to be recognized that the spiral-forming
balloon catheter of the present invention has many different
applications, in addition to the use in thrombus removal described
above. For example, the expanded spiral balloon may be used for
anchoring a catheter (or other elongate device) within a blood
vessel, without blocking blood flow in the region of the anchoring
balloon.
[0106] In addition, in other applications, the spiral balloon may
be used for the purpose of cooling or heating tissue or blood in
the immediate vicinity of said balloon.
[0107] In another aspect, the balloon may be covered or partly
covered with a network of thin filaments, thereby creating a distal
protection element, which may serve to enhance the ability of the
spiral balloon to trap thrombotic material during withdrawal of the
catheter.
[0108] A further application for the spiral-forming balloon of the
present invention is in the treatment and/or remodeling of vascular
aneurysms (including, but not limited to, cerebral aneurysms).
Prior art methods of treatment generally use an inflated catheter
balloon as a `floor` or base during the insertion of coils into the
aneurysm that is being re-modeled. However, one drawback of the use
of conventional balloons in this situation is that blockage (total
or near-total) of blood flow in the region of the aneurysm. This
blockage may clearly have serious negative implications,
particularly when dealing with a cerebral aneurysm. The use of a
spiral-forming balloon of the present invention, however, permits
blood flow to continue through and around the spiral channels,
thereby preventing ischemic and hypoxic damage to sensitive tissues
distal to the treatment site.
[0109] In a further modification of the methods of use disclosed
and described hereinabove, following insertion of the catheter
system of the present invention into the body, and its arrival at
the intended working site, said catheter may be left in situ for
periods of up to several hours, in order perform its various
functions (e.g. thrombus collection) as a temporary indwelling
device.
[0110] All of the abovementioned parameters are given by way of
example only, and may be changed in accordance with the differing
requirements of the various embodiments of the present invention.
Thus, the abovementioned parameters should not be construed as
limiting the scope of the present invention in any way.
EXAMPLE
Influence of Key Balloon Parameters on their Ability to Adopt a
Spiral Conformation
[0111] The following table summarizes certain key parameters of a
series of different compliant balloons which were bound at both
ends to a rigid catheter (diameter 0.3 mm). In the cases in which a
spiral conformation was not achieved following inflation with
water, this fact is mentioned in the `comments` column of the
table:
TABLE-US-00001 Balloon % Elongation OD ID L.sub.0 Number of Spiral
Balloon Material at break [mm] [mm] [mm] Threads (N) OD [mm]
Comments TPE* 510 0.8 0.4 20 3 4.5 TPE 510 0.9 0.5 20 3 5.5 TPE 700
0.8 0.4 20 2.5 7.5 Silicone 373 0.8 0.4 20 4 4 Silicone 373 0.6 0.3
20 N/A N/A Spiral balloon was not formed due to no space between
the ID of the balloon and the OD of the shaft. Silicone 373 0.8 0.4
7 N/A N/A A spiral balloon was not formed. The initial length was
too short. Polyurethane 50 0.8 0.4 20 N/A N/A A spiral balloon was
not formed due to an elongation which was too low. *The TPE used in
this study was Evoprene Super G 948 (Alpha Gary Company)
[0112] It will be seen from the proceeding table that only the
balloons characterized by having certain structural parameters
(e.g. length, diameter, material etc.) are capable of adopting a
spiral conformation upon inflation.
[0113] While specific embodiments of the invention have been
described for the purpose of illustration, it will be understood
that the invention may be carried out in practice by skilled
persons with many modifications, variations and adaptations,
without departing from its spirit or exceeding the scope of the
claims.
* * * * *