U.S. patent application number 14/313667 was filed with the patent office on 2015-01-15 for percutaneous transluminal angioplasty device with integral embolic filter.
The applicant listed for this patent is CONTEGO MEDICAL, LLC. Invention is credited to LARRY A. ROBERTS, RAVISH SACHAR, GREGG SUTTON.
Application Number | 20150018928 14/313667 |
Document ID | / |
Family ID | 39592024 |
Filed Date | 2015-01-15 |
United States Patent
Application |
20150018928 |
Kind Code |
A1 |
SACHAR; RAVISH ; et
al. |
January 15, 2015 |
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DEVICE WITH INTEGRAL EMBOLIC
FILTER
Abstract
A percutaneous transluminal angioplasty device having an embolic
filter mounted to the catheter shaft at a location distal to the
angioplasty balloon and downstream from the blockage to capture
embolic particles that may be set loose into the blood stream as
the angioplasty procedure is performed. The embolic filter is
normally collapsed against the catheter shaft to facilitate
introduction and withdrawal of the device to and from the operative
site. Once the angioplasty balloon is properly positioned, however,
means operatively associated with the embolic filter are actuated
to erect the filter to operatively position a filter mesh across
the lumen of the vessel.
Inventors: |
SACHAR; RAVISH; (Raleigh,
NC) ; SUTTON; GREGG; (Maple Grove, MN) ;
ROBERTS; LARRY A.; (Atlanta, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CONTEGO MEDICAL, LLC |
Raleigh |
NC |
US |
|
|
Family ID: |
39592024 |
Appl. No.: |
14/313667 |
Filed: |
June 24, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13850782 |
Mar 26, 2013 |
8758424 |
|
|
14313667 |
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|
10997803 |
Nov 24, 2004 |
8403976 |
|
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13850782 |
|
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|
60560934 |
Apr 8, 2004 |
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Current U.S.
Class: |
623/1.11 ;
606/200 |
Current CPC
Class: |
A61F 2/958 20130101;
A61F 2230/008 20130101; A61M 25/104 20130101; A61F 2230/0008
20130101; A61F 2/013 20130101; A61F 2230/0006 20130101; A61F
2002/018 20130101; A61F 2/01 20130101; A61F 2230/0069 20130101 |
Class at
Publication: |
623/1.11 ;
606/200 |
International
Class: |
A61F 2/01 20060101
A61F002/01; A61M 25/10 20060101 A61M025/10; A61F 2/958 20060101
A61F002/958 |
Claims
1. A percutaneous transluminal angioplasty device, comprising: an
elongated catheter having proximal and distal ends and an outer
side wall; a filter attached to the elongated catheter, the filter
being collapsible for insertion of the distal end of the catheter
into a blood vessel, and the filter being expandable to an expanded
position, wherein the filter comprises: a movable ring portion
movably attached to the catheter; a fixed ring portion immovably
attached to the catheter such that the movable ring portion is
movable relative to the fixed ring portion, wherein the movable
ring portion is distal to the fixed ring portion; a plurality of
elongated ribs attached to the fixed and movable ring portions,
wherein the ribs are formed of a shape memory material that urges
the ribs into a collapsed position and a filter mesh overlying a
portion of the ribs; wherein the catheter further comprises a lumen
and a port in communication with the lumen, the port comprising an
aperture in the outer side wall of the catheter located distal to
the fixed ring portion and proximal to the movable ring portion,
and the lumen extending from a location proximate the proximal end
of the catheter to the port; and an actuator wire having proximal
and distal ends, the actuator wire extending through the lumen of
the catheter, and the distal end of the actuator wire exiting the
lumen of the catheter through the port, the distal end of the
actuator wire being attached to the movable ring portion; wherein,
when the filter is in the collapsed position, pulling on the
proximal end of the wire exerts a force on the movable ring portion
in the proximal direction that moves the movable ring portion
toward the fixed ring portion and causes the ribs to bow outward to
expand the filter to the expanded position; wherein, when the
filter is in the expanded position, releasing tension on the wire
permits the shape memory of the ribs to return the ribs to their
normal, collapsed position, collapsing the filter.
2. The percutaneous transluminal angioplasty device of claim 1,
further comprising an interventional device attached to the
catheter adjacent the distal end thereof, wherein the filter is
positioned between the interventional device and the distal end of
the catheter.
3. The percutaneous transluminal angioplasty device of claim 2,
wherein the interventional device comprises an angioplasty
balloon.
4. The percutaneous transluminal angioplasty device of claim 2,
wherein the interventional device comprises a stent.
5. The percutaneous transluminal angioplasty device of claim 2,
wherein the interventional device comprises a mechanical
thrombectomy device.
6. The percutaneous transluminal angioplasty device of claim 1,
wherein the shape memory material comprises nitinol.
7. The percutaneous transluminal angioplasty device of claim 1,
wherein filter mesh overlies a distal portion of the ribs, and
wherein, in the expanded position, the ribs bow outward, radially
expanding the filter mesh.
8. The percutaneous transluminal angioplasty device of claim 1,
wherein the filter mesh extends beyond the ribs in a longitudinal
direction relative to the longitudinal axis of the catheter, such
that a sac is formed to retain embolic particles when the filter is
in the collapsed position.
9. The percutaneous transluminal angioplasty device of claim 1,
wherein filter mesh overlies a distal portion of the ribs, and
wherein, in the expanded position, the ribs bow outward, radially
expanding the filter mesh.
10. A percutaneous transluminal angioplasty device, comprising: an
elongated catheter having proximal and distal ends; an
interventional device attached to the catheter adjacent the distal
end thereof, a filter attached to the elongated catheter, the
filter being collapsible for insertion and removal of the distal
end of the catheter into a blood vessel, and the filter being
expandable to an expanded position to capture emboli released into
a bloodstream, wherein the filter comprises: a movable ring portion
movably attached to the catheter; a fixed ring portion immovably
attached to the catheter such that the movable ring portion is
movable relative to the fixed ring portion; a plurality of
elongated ribs extending longitudinally between and attached to the
fixed and movable ring portions; and a filter mesh overlying a
portion of the ribs, wherein the ribs are formed of a shape memory
material that urges the ribs into a collapsed position; wherein the
catheter further comprises a lumen extending from a location
proximate the proximal end of the catheter, to a location distal to
the interventional device; and an actuator wire having proximal and
distal ends, the actuator wire extending through the lumen of the
catheter, the proximal end of the actuator wire extending to a
location proximate the proximal end of the catheter and the distal
end of the actuator wire exiting the lumen through the side wall of
the catheter at the location distal to the interventional device,
the distal end of the actuator wire being attached to the movable
ring portion; wherein when the filter is in a collapsed condition,
manipulating the proximal end of the wire exerts a force on the
movable ring portion that moves the movable ring portion toward the
fixed ring portion and causes the ribs to bow outward to the
expanded position.
11. The percutaneous transluminal angioplasty device of claim 10,
wherein the filter is positioned between the interventional device
and the distal end of the catheter.
12. The percutaneous transluminal angioplasty device of claim 10,
wherein the movable ring portion is the distal ring portion.
13. The percutaneous transluminal angioplasty device of claim 12,
wherein the distal end of the actuator wire exits the lumen through
the catheter side wall at a location distal to the proximal ring
portion.
14. The percutaneous transluminal angioplasty device of claim 13,
wherein the distal end of the actuator wire is operatively
connected to the distal ring portion.
15. The percutaneous transluminal angioplasty device of claim 14,
wherein pulling on the proximal end of the actuator wire draws the
distal ring portion toward the fixed proximal ring portion.
16. The percutaneous transluminal angioplasty device of claim 10,
wherein the movable ring portion is the proximal ring portion.
17. The percutaneous transluminal angioplasty device of claim 16,
wherein the distal end of the actuator wire exits the lumen through
the catheter side wall at a location proximal to the proximal ring
portion.
18. The percutaneous transluminal angioplasty device of claim 17,
wherein the distal end of the actuator wire is operatively
connected to the proximal ring portion.
19. The percutaneous transluminal angioplasty device of claim 18,
wherein pushing on the proximal end of the actuator wire moves the
proximal ring portion toward the fixed distal ring portion.
20. The percutaneous transluminal angioplasty device of claim 16,
wherein the distal end of the actuator wire exits the lumen through
the catheter side wall at a location distal to the proximal ring
portion.
21. The percutaneous transluminal angioplasty device of claim 20,
wherein the distal end of the actuator wire passes through an
opening defined by the fixed distal ring portion and then returns
to be is operatively connected to the proximal ring portion.
22. The percutaneous transluminal angioplasty device of claim 21,
wherein pulling on the proximal end of the actuator wire moves the
proximal ring portion toward the fixed distal ring portion.
23. The percutaneous transluminal angioplasty device of claim 10,
wherein the interventional device comprises an angioplasty
balloon.
24. The percutaneous transluminal angioplasty device of claim 10,
wherein the interventional device comprises a stent.
25. The percutaneous transluminal angioplasty device of claim 10,
wherein the interventional device comprises a mechanical
thrombectomy device.
26. The percutaneous transluminal angioplasty device of claim 10,
wherein the shape memory material comprises nitinol.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a Continuation of U.S. application Ser.
No. 13/850,782, filed Mar. 26, 2013, now U.S. Pat. No. 8,758,424
issued Jun. 24, 2014; which is a Continuation of U.S. application
Ser. No. 10/997,803, filed Nov. 24, 2004, now U.S. Pat. No.
8,403,976 issued Mar. 26, 2013, which claims benefit of U.S.
Provisional Application No. 60/560,934, filed Apr. 8, 2004, which
applications are herein incorporated by reference in their
entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to surgical devices
and relates more specifically to a percutaneous transluminal
angioplasty device.
BACKGROUND OF THE INVENTION
[0003] The vascular bed supplies a constant flow of oxygen-rich
blood to the organs. If plaque builds up in these vessels,
blockages can develop, reducing blood flow to the organs and
causing adverse clinical symptoms, up to and including
fatality.
[0004] Angioplasty is a catheter-based procedure performed by a
physician to open up a blocked vessel and restore blood flow. An
entry site is opened, for example in the patient's groin, arm, or
hand, and a guide wire and catheter are advanced under fluoroscopic
guidance to the location of the blockage. A catheter having a small
balloon adjacent its distal end is advanced under fluoroscopic
guidance until the balloon lies within the stenosed region. The
balloon is then inflated and deflated one or more times to expand
the stenosed region of the artery.
[0005] Since diseased vessels are comprised of a range of material
from early-stage thrombosis to late-stage calcified plaque,
angioplasty can release embolic particles downstream from the
stenosed location. These embolic particles can result in adverse
clinical consequences. It has been shown that it is beneficial to
trap these embolic particles to prevent them from traveling
downstream with blood flow to the capillary bed (e.g., Bairn D S,
Wahr D, George B, et al., Randomized Trial of a Distal Embolic
Protection Device During Percutaneous Intervention of Saphenous
Vein Aorto-Coronary Bypass Grafts, Circulation 2002;
105:1285-90).
[0006] In addition to balloon angioplasty, stenoses may also be
treated with stents and with mechanical thrombectomy devices. These
devices are also prone to releasing embolic particles downstream
from the stenosed location.
[0007] There are systems available today that are used to catch
these embolic particles. They are primarily filter systems or
occlusion balloon systems built on a guidewire. These systems have
shortcomings related to simplicity of use and crossing tight
lesions with a filter or balloon guidewire that is larger in
diameter than the guide wire which is normally used. These embolic
protection guidewires also have flexibility and stability problems
that make the protected angioplasty procedure difficult in many
cases. In the case of saphenous vein grafts, the problems relate
specifically to aorto-ostial lesions, where the guidewire may not
be long enough to provide support, or distal vein graft lesions,
where there is not enough of a landing zone for the filter. The
latter is a problem as currently available filter systems have a
considerable distance between the treatment balloon and the distal
filter. This distance is a problem not only in distal vein graft
lesions, but also in arterial stenoses in which there is a side
branch immediately after the stenosis. In such cases, the filter
can often be deployed only distal to the side branch, thus leaving
the side branch unprotected from embolic particles.
SUMMARY
[0008] Stated generally, the present invention comprises a
percutaneous transluminal angioplasty device with integral embolic
filter. Because the filter is integral with the catheter of the
angioplasty device, there is no need to insert a separate device
into the vessel. Further, proper placement of the angioplasty
balloon assures proper placement of the embolic filter.
[0009] Stated somewhat more specifically, the percutaneous
transluminal angioplasty device of the present invention comprises
an embolic filter mounted to the catheter shaft at a location
distal to the angioplasty balloon, stent, or mechanical
thrombectomy device. Thus the filter is downstream from the
blockage and is properly positioned to capture embolic particles
that may be set loose into the blood stream as the angioplasty
procedure is performed. The embolic filter is normally collapsed
against the catheter shaft to facilitate introduction and
withdrawal of the device to and from the operative site. Once the
angioplasty balloon, stent, or mechanical thrombectomy device is
properly positioned, however, means operatively associated with the
embolic filter are actuated to erect the filter to position a
filter mesh across the lumen of the coronary artery.
[0010] In some embodiments the means for erecting the filter
comprises a balloon which longitudinally displaces one end of the
filter toward the other, causing longitudinal ribs to bow outward,
thus erecting the filter mesh. In other embodiments the means for
erecting the filter comprises a balloon interposed within the
proximal and distal ends of the filter, whereby inflating the
balloon will bias the ribs away from the catheter shaft, causing
the ribs to bow outwardly to erect the filter mesh. In still other
embodiments the means for erecting the filter comprises a pull wire
attached to one end of the filter, such that pulling on the wire
longitudinally displaces one end of the filter toward the other,
causing longitudinal ribs to bow outward, thus erecting the filter
mesh.
[0011] In one embodiment of the invention, a reservoir is provided
at the distal tip of the filter so that when the device collapses
for withdrawal, debris does not get pushed out of the filter.
[0012] Additional advantages of the invention will be set forth in
part in the description which follows, and in part will be obvious
from the description, or can be learned by practice of the
invention. The advantages of the invention will be realized and
attained by means of the elements and combinations particularly
pointed out in the appended claims. It is to be understood that
both the foregoing general description and the following detailed
description are exemplary and explanatory only and are not
restrictive of the invention, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate several aspects
of the invention and together with the description, serve to
explain the principles of the invention.
[0014] FIG. 1 is a partial cut away side view of first embodiment
of a percutaneous transluminal angioplasty device according to a
first embodiment of the disclosed invention, with the angioplasty
balloon and embolism filter in their collapsed positions.
[0015] FIG. 2 is a partial cut away side view of the percutaneous
transluminal angioplasty device of FIG. 1 showing the angioplasty
balloon and embolism filter in their erected positions.
[0016] FIG. 3 is a cross sectional view taken along line 3-3 of
FIG. 1.
[0017] FIG. 4 is a cross sectional view taken along line 4-4 of
FIG. 1.
[0018] FIG. 5 is a cross sectional view taken along line 5-5 of
FIG. 1.
[0019] FIG. 6 is a second embodiment of a percutaneous transluminal
angioplasty device according to the present invention, which
differs from the percutaneous transluminal angioplasty of FIGS. 1
and 2 in that the actuation balloon is on the proximal side of the
embolic filter, and the filter erects from a different
direction.
[0020] FIG. 7 is a view of the percutaneous transluminal
angioplasty device of FIG. 6 showing the angioplasty balloon
inflated and the embolic filter erected.
[0021] FIG. 8 is a third embodiment of a percutaneous transluminal
angioplasty device and differs from the previously described
embodiments in that the means for erecting the embolic filter is a
bellows. FIG. 8 shows the angioplasty balloon and the embolic
filter in their collapsed positions.
[0022] FIG. 9 is another view of the percutaneous transluminal
angioplasty device of FIG. 8 showing the angioplasty balloon and
the embolic filter in their inflated or raised positions.
[0023] FIG. 10 is another embodiment of a percutaneous transluminal
angioplasty device according to the present invention which employs
a bellows to raise and lower the embolic filter. The embodiment of
FIG. 10 differs from the embodiment of FIGS. 8 and 9 in that the
bellows is disposed on the distal end of the filter such that the
filter opens from the opposite direction. FIG. 10 shows the
angioplasty balloon and the embolic filter in their deflated or
collapsed positions.
[0024] FIG. 11 is another view of the percutaneous transluminal
angioplasty device of FIG. 10, showing the angioplasty balloon
inflated and the embolic filter raised.
[0025] FIG. 12 shows still another embodiment of a percutaneous
transluminal angioplasty device according to the present invention,
in which the balloon interposed between the catheter shaft and the
ribs forces the ribs upward, thereby causing them to bow into the
erected embolic filter. FIG. 12 shows the device with the
angioplasty balloon and the embolic filter in their collapsed or
lowered positions.
[0026] FIG. 13 is another view of the percutaneous transluminal
angioplasty device of FIG. 12, showing the angioplasty balloon in
its inflated condition and the embolic filter in its erected
condition.
[0027] FIG. 14 is another embodiment of a percutaneous transluminal
angioplasty device according to the present invention. This
embodiment differs from the embodiments of FIGS. 12 and 13 in that
the balloon is located at the opposite end of the filter.
Nonetheless, when inflated, the balloon forces the ribs away from
the shaft and into their accurate positions, thereby raising the
embolic filter. FIG. 14 shows the embodiment with the angioplasty
balloon collapsed and the embolic filter retracted against the
catheter shaft.
[0028] FIG. 15 is another view of the embodiment of FIG. 14,
showing the angioplasty balloon inflated and the embolic filter
erected.
[0029] FIG. 16 is still another embodiment of a percutaneous
transluminal angioplasty device according to the present invention.
This embodiment employs a pull wire operable from outside the
patient which is attached to a front ring of the embolic filter.
When the physician exerts tension on the wire, the distal ring is
displaced proximally, bringing it closer to the proximal ring,
thereby causing the ribs to bow outward and thereby erecting the
embolic mesh filter. FIG. 16 shows the device with the angioplasty
balloon deflated and the embolic filter collapsed against the
catheter shaft.
[0030] FIG. 17 is a different view of the embodiment of FIG. 16 and
shows the angioplasty balloon inflated and the embolic filter
erected.
[0031] FIG. 18 is another embodiment of a percutaneous transluminal
angioplasty device according to the present invention, showing the
angioplasty balloon and the embolic filter in their collapsed
conditions.
[0032] FIG. 19 is another view of the embodiment of FIG. 18,
showing the angioplasty balloon inflated and the embolic filter
raised.
[0033] FIG. 20 is yet another embodiment of a percutaneous
transluminal angioplasty device according to the present invention,
showing the angioplasty balloon and the embolic filter in their
collapsed conditions.
[0034] FIG. 21 is another view of the embodiment of FIG. 20,
showing the angioplasty balloon inflated and the embolic filter
raised.
[0035] FIG. 22 shows a side cut away view of a coronary artery with
a stenosis.
[0036] FIG. 23 shows the coronary artery of FIG. 20 with a guide
wire fed through the coronary artery and through the stenosis.
[0037] FIG. 24 shows the device of FIG. 1 threaded over the guide
wire of FIG. 23 and positioned such that the angioplasty balloon is
located within the stenosis.
[0038] FIG. 25 illustrates the angioplasty balloon in its inflated
condition to reduce the stenosis, and the embolic filter has been
erected to capture any embolic particles that may break loose into
the blood stream as a result of the angioplasty procedure.
[0039] FIG. 26 is a partial cut away side view of an embodiment of
a device in which the angioplasty balloon and embolism filter,
shown in their collapsed positions, are reversed on the catheter
shaft for peripheral vascular applications in which blood flows in
the opposite direction.
[0040] FIG. 27 is a partial cut away side view of the device of
FIG. 26 showing the angioplasty balloon and embolism filter in
their erected positions.
[0041] FIG. 28 is a side view of an embolism filter according to
another embodiment of the present invention.
[0042] FIG. 29 is a side view of the embolism filter of FIG. 28
with the inflation balloon expanded to erect the embolism filter;
filter mesh is shown removed to reveal interior detail.
[0043] FIG. 30 is a side view of the embolism filter of FIG. 28
with the inflation balloon deflated; filter mesh is shown removed
to reveal interior detail.
[0044] FIG. 31 is a side view of the embolism filter of FIG. 28
being retracted into the forward end of a catheter to collapse the
filter; filter mesh is shown removed to reveal interior detail.
[0045] FIG. 32 is a side view of the embolism filter of FIG. 28,
with the filter expanded and filter mesh in place.
[0046] FIG. 33 is a side cutaway view of another embodiment of an
angioplasty device showing an angioplasty balloon in its deflated
condition and an embolic filter in a retracted state.
[0047] FIG. 34 is a side cutaway view of the angioplasty device of
FIG. 33 showing the angioplasty balloon inflated and the embolic
filter erected.
[0048] FIG. 35 is a side view of a further embodiment of an
angioplasty device in which the filter mesh extends beyond the end
of the ribs so as to form a sac when the filter is collapsed.
[0049] FIG. 36 is a side view of the embodiment of the angioplasty
device of FIG. 35 in a collapsed configuration.
DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENTS
[0050] The present invention can be understood more readily by
reference to the following detailed description, examples,
drawings, and claims, and their previous and following description.
However, before the present devices, systems, and/or methods are
disclosed and described, it is to be understood that this invention
is not limited to the specific devices, systems, and/or methods
disclosed unless otherwise specified, as such can, of course, vary.
It is also to be understood that the terminology used herein is for
the purpose of describing particular aspects only and is not
intended to be limiting.
[0051] The following description of the invention is provided as an
enabling teaching of the invention in its best, currently known
embodiment. To this end, those skilled in the relevant art will
recognize and appreciate that many changes can be made to the
various aspects of the invention described herein, while still
obtaining the beneficial results of the present invention. It will
also be apparent that some of the desired benefits of the present
invention can be obtained by selecting some of the features of the
present invention without utilizing other features. Accordingly,
those who work in the art will recognize that many modifications
and adaptations to the present invention are possible and can even
be desirable in certain circumstances and are a part of the present
invention. Thus, the following description is provided as
illustrative of the principles of the present invention and not in
limitation thereof.
[0052] As used throughout, the singular forms "a," "an" and "the"
include plural referents unless the context clearly dictates
otherwise. Thus, for example, reference to "lumen" can include two
or more such lumens unless the context indicates otherwise.
[0053] Ranges can be expressed herein as from "about" one
particular value, and/or to "about" another particular value. When
such a range is expressed, another aspect includes from the one
particular value and/or to the other particular value. Similarly,
when values are expressed as approximations, by use of the
antecedent "about," it will be understood that the particular value
forms another aspect. It will be further understood that the
endpoints of each of the ranges are significant both in relation to
the other endpoint, and independently of the other endpoint.
[0054] As used herein, the terms "optional" or "optionally" mean
that the subsequently described event or circumstance can or cannot
occur, and that the description includes instances where said event
or circumstance occurs and instances where it does not.
[0055] The present invention can be understood more readily by
reference to the following detailed description of preferred
embodiments of the invention and the examples included therein and
to the Figures and their previous and following description.
[0056] Referring now to the drawings, FIGS. 1 and 2 illustrate a
first embodiment of a percutaneous transluminal angioplasty device
10 according to the present invention. The device 10 comprises an
elongated catheter 12 having a shaft 14 with a proximal end (not
shown) and a distal end 16. Spaced a short distance proximally from
the distal end 16 of the catheter 12 is an angioplasty balloon 18
of conventional design. In FIG. 1 the angioplasty balloon 18 is
shown in a deflated or collapsed condition. In FIG. 2 the
angioplasty balloon 18 is shown in an inflated condition.
[0057] Located between the angioplasty balloon 18 and the distal
tip 14 of the catheter 12 is a collapsible filter 20. The filter 20
includes a proximal ring portion 22 and a distal ring portion 24. A
plurality of elongated ribs 26 extend generally longitudinally
between the proximal and distal rings 22, 24. These ribs can be
made of a shape memory material, such as nitinol, and in their
baseline position, these ribs are collapsed. A filter mesh 28
overlies the distal portion of the ribs 26. In the embodiment of
FIGS. 1 and 2, the distal ring 24 is movable toward and away from
the proximal ring 22. As the distal ring 24 moves toward the
proximal ring 22, the ribs 26 bow outward. As the ribs 26 bow
outward, the filter mesh 28 overlaying the ribs is erected. FIG. 1
shows the filter 20 in its collapsed condition, while FIG. 2 shows
the filter in its erected condition.
[0058] Means 34 are included for erecting and collapsing the filter
20 of the device 10 shown in FIGS. 1 and 2. Specifically a balloon
36 has its distal end 38 bonded to the shaft 14 of the catheter 12.
When the distal ring 24 is in its withdrawn position, as shown in
FIG. 1, the bulk of the balloon 36 is folded forward over the shaft
14 of the catheter 12. When the balloon 36 is inflated, as shown in
FIG. 2, the balloon 36 expands proximally, pushing the distal ring
24 in a proximal direction, causing the ribs 26 to bow outward and
thereby erecting the filter 20. When the balloon 32 is deflated,
the shape memory ribs straighten, urging the distal ring 24 in a
distal direction and collapsing the filter 20 close to the shaft 14
of the catheter 12.
[0059] FIGS. 3, 4, and 5 show cross sections of the device 10 at
various locations along its length. Referring first to FIG. 3, the
catheter shaft 12 has three lumens: two smaller lumens and a large
main lumen. The two smaller lumens are inflation lumens, one lumen
40 for the angioplasty balloon 18, and one lumen 42 for the balloon
36 which controls the filter 20. The larger main lumen 44 is used
to receive a guide wire (not shown) over which the device 10
advanced to position the device for performing an angioplasty
procedure.
[0060] Referring now to FIG. 4, this cross section is taken at a
location distal to the angioplasty balloon 18. Consequently, the
angioplasty balloon inflation lumen 40 has terminated and is no
longer visible. Thus, FIG. 4 shows only two lumens, the main lumen
44 for receiving the guide wire, and the smaller inflation lumen 42
for the filter balloon 36.
[0061] Referring now to FIG. 5, this cross section is taken at a
location distal to the filter balloon 36, and hence only the main
lumen 44 is visible.
[0062] FIGS. 6 and 7 show an alternate embodiment of a percutaneous
transluminal angioplasty device 110 according to the present
invention. This device is similar to the device 10 previously
described, with the exception that the filter 120, in this case,
has its distal ring 124 fixed, and the proximal ring 122 of the
filter 120 is movable toward and away from the distal ring to cause
the ribs 126 to bow outwardly or to straighten. The balloon 136 is
located on the proximal side of the filter 120 and pushes the
proximal ring 122 in a distal direction when the balloon 136 is
inflated.
[0063] Referring now to FIGS. 8 and 9, yet another alternate
embodiment of percutaneous transluminal angioplasty device 210 is
shown. This device is similar to the device shown in FIGS. 1 and 2,
with the exception that the means for erecting the filter 220 is a
bellows 236, instead of a balloon. In FIG. 8, the bellows 236 is
un-inflated and hence it is in a collapsed condition, permitting
the ribs 226 of the filter 220 to straighten out against the shaft
214 of the catheter 212. In FIG. 9, the bellows 236 has been
inflated, pushing the proximal ring 222 in a distal direction,
bowing out the ribs 236 and erecting the filter mesh 238.
[0064] FIGS. 10 and 11 illustrate still another embodiment of a
percutaneous transluminal angioplasty device 310. This device is
similar to the device shown in FIGS. 8 and 9, with the exception
that the bellows 336 is placed on the distal side of the filter
320. Thus, when the bellows 336 is inflated, it moves the distal
ring 324 in a proximal direction toward the proximal ring 322,
thereby causing the ribs 326 to bow outwardly, erecting the filter
mesh 338.
[0065] FIGS. 12 and 13 depict another embodiment of a percutaneous
transluminal angioplasty device 410. In this device the means for
erecting the filter comprises a balloon 436 disposed between the
catheter shaft 414 and the ribs 426 adjacent the fixed distal ring
424 of the filter 420. When the balloon 436 is inflated, it forces
the ribs 426 outward away from the catheter shaft 414, thereby
bowing the ribs and drawing the proximal ring 422 of the filter 420
in a distal direction. As the ribs 426 bow outward, the filter mesh
428 is erected, thereby raising the filter 420.
[0066] FIGS. 14 and 15 show a device 510 similar to that shown in
FIGS. 12 and 13, with the exception that the balloon 536 is placed
between the catheter shaft 512 and the ribs 526 adjacent the
proximal ring 522 of the filter 520. In the device 510, the distal
ring 524 is free to slide along the catheter shaft 512, such that
when the balloon 536 is inflated and forces the ribs 526 to bow
outward, the distal ring 524 slides in a proximal direction, as
indicated by the arrow 539 as shown in FIG. 15, permitting the
filter 520 to raise.
[0067] The embodiment 610 shown in FIGS. 16 and 17 employs a
different means for erecting the filter 620. In the embodiment 610
a pull wire 650 is used. The pull wire 650 extends through what
would formerly have been used as the filter balloon inflation lumen
644, and the distal end 652 of the pull wire 650 is attached to the
distal ring 624. When the physician wishes to raise the filter 620,
he exerts a tension on the wire 650, as indicated by the arrow 653,
thus drawing the distal ring 624 in a proximal direction as
indicated by the arrow 655 toward the proximal ring 622. The ribs
bow outward, erecting the filter mesh 628 as shown in FIG. 17.
[0068] In the device 710 shown in FIGS. 18 and 19, the distal end
752 of a push wire 750 is attached to the proximal ring 722. Thus
when the wire 750 is pushed in the direction indicated by the arrow
753, the proximal ring 722 is advanced distally toward the distal
ring 724 in the direction indicated by the arrow 755, causing the
ribs 726 to bow outward and thereby erecting the filter 720, as
shown in FIG. 19.
[0069] The device 810 shown in FIGS. 20 and 21 uses a pull wire 850
to erect the filter 820. The pull wire 850 wraps around an opening
851 in the stationary distal ring 824 and extends rearward toward
the proximal ring 822 to which the distal end 852 of the pull wire
is attached. Thus when tension is exerted on the pull wire 850 in
the direction indicated by the arrow 853, the proximal ring 822 is
drawn distally toward the distal ring 824 in the direction
indicated by the arrow 855, causing the ribs 826 to bow outward and
thereby erecting the filter 820, as shown in FIG. 21.
[0070] The operation of the device 10 will now be explained with
respect to FIGS. 22-25, and it will be understood that the other
devices operate on a substantially the same principles. FIG. 22
shows a vascular structure (e.g., coronary artery, saphenous vein
graft, renal artery, carotid artery, superficial femoral artery,
etc.) 900 with upper and lower walls 902, 904, a branch vessel 905,
and a stenosis or blockage 906 caused by the build-up of plaque or
other substances on the arterial walls in such a way as to narrow
the diameter of the arterial lumen, and m the process, constrict
the flow of blood therethrough.
[0071] In FIG. 23, a guide wire 908 has been inserted by the
physician, such as through the femoral artery, and guided through
the vascular system until the guide wire passes through the
stenosis 906 in the vascular structure 900.
[0072] Referring now to FIG. 24, the apparatus 10 has been inserted
over the guide wire 908 and advanced to a location wherein the
angioplasty balloon resides within the stenosis 906. The embolic
filter 20 resides a few centimeters distal or downstream from the
angioplasty location. In FIG. 24 both the angioplasty balloon and
the embolic filter are shown in their collapsed conditions.
[0073] In FIG. 25 the embolic filter 20 has been erected by
inflating the filter balloon 36, causing the distal ring 22 to
slide in a proximal direction along the catheter shaft 12. As the
ribs 26 bow outward, the mesh filter material 28 supported by the
ribs spreads so as to cover substantially the entire arterial
lumen. The angioplasty balloon 18 is now inflated. As the balloon
18 inflates, it pushes tissue and plaque forming the stenosis 906
outward, opening the stenosis and possibly loosening embolic
particles in the process. Any such embolic particles which get
captured in the blood stream will be caught by the embolic filter
20 and will thereby be prevented from traveling to a location where
they can cause clinical damage.
[0074] Of interest in FIG. 25 is the close proximity in which the
filter 20 is erected relative to the stenosis 906. Despite the
short "landing area" between the stenosis 906 and the branch vessel
905, the filter 20 is erected to capture embolic particles upstream
of the branch vessel.
[0075] When removing the device 10 from the coronary artery, the
preferred procedure is to deflate the angioplasty balloon 18 to
first, prior to collapsing the embolic filter 20. In this way, any
embolic particles that are broken loose as the angioplasty balloon
18 deflates will be captured by the filter 20. The embolic filter
balloon 20 is then deflated; permitting the ribs 26 and filter mesh
28 to collapse against the shaft 14 of the catheter 12. Any embolic
particles captured by the mesh 28 are trapped against the shaft 14.
The device 10 is then withdrawn over the guide wire 908 and removed
from the patient's body.
[0076] In various peripheral vascular applications, it may be
necessary to insert the catheter against the direction of blood
flow (e.g., the aorta). FIGS. 26 and 27 illustrate a device 1000 in
which the angioplasty balloon 1018 and the embolic filter 1020 are
reversed on the shaft 1014 of the catheter 1012. Thus with the
blood flowing within the vessel in the direction indicated by the
arrow 1080, the embolic filter 1020 will be proximal to the
angioplasty balloon 1018 and thus positioned to capture any embolic
particles that may be dislodged by the angioplasty balloon.
[0077] While the embodiment 1000 of FIGS. 26 and 27 employs the
same method and device for erecting the embolic filter as the
embodiment 10 of FIGS. 1-3, it will be understood that the methods
and devices for erecting the embolic filter of other embodiments
disclosed above are equally applicable to a configuration like the
device of embodiment 1000 where the angioplasty balloon is
positioned between the embolic filter and the tip of the
device.
[0078] FIGS. 28-32 show still another embodiment of an embolic
filter 1120 for use in conjunction with an angioplasty balloon.
FIGS. 28-32 show only the embolic filter 1120 and not the
angioplasty balloon, but it will be understood that the embolic
filter is located on the same catheter 1114 as the angioplasty
balloon in the same manner as the embodiments previously disclosed.
Further, FIGS. 29-31 show the embolic filter 1120 without its
filter mesh 1128 for clarity of illustration.
[0079] In FIG. 28 the embolic filter 1120 is folded closely against
the shaft of the catheter 1112. The ribs 1126 of the filter 1120
extend between a proximal ring portion 1122 and a distal ring
portion 1124. The distal ring portion 1124 is slidably mounted on
the shaft 1114 of the catheter 1112, and the proximal ring portion
1122 is fixed with relation to the shaft of the catheter. In FIG.
29 the embolic filter balloon 1136 has been inflated, embolic
filter. As the ribs expand, the distal ring portion 1124 slides in
the proximal direction, as shown by the arrow 1188. Once expanded,
the ribs 1126 maintain their shape, such that when the embolic
filter balloon 1136 is deflated, as shown in FIG. 30, the embolic
filter 1120 remains expanded.
[0080] To retract the embolic filter 1120, a second, outer catheter
1190 is advanced over the catheter 1112, as shown in FIG. 31,
causing the ribs 1126 to collapse as the embolic filter is
withdrawn into the forward end of the outer catheter 1190. As the
ribs 1126 collapse, the distal ring portion 1124 slides in the
distal direction. Once the embolic filter 1120 has been completely
retracted into the forward end of the outer catheter 1190, the
outer and inner catheters are withdrawn simultaneously.
[0081] FIG. 32 shows the embolic filter 1120 with filter mesh 1128
positioned over the ribs 1126.
[0082] FIGS. 33 and 34 illustrate a further embodiment of a
percutaneous angioplasty device 1210, in which the embolic filter
1220 is located on a different carrier than the angioplasty balloon
1218. Specifically, the angioplasty balloon 1218 is located on an
outer catheter 1294, and the embolic filter 1220 is located at the
forward end of an inner catheter 1295 (the embolic filter 1220 is
shown without filter mesh in FIGS. 33 and 34 for clarity of
illustration.) The outer catheter preferably has three lumens, one
for inflating the angioplasty balloon 1218, one for accommodating a
guide wire (not shown), and one for receiving the inner catheter
1295 and embolic filter 1220. The inner catheter 1295 is slidably
telescopically disposed within the outer catheter 1294. The ribs
1226 of the embolic filter 1220 are formed from a shape-memory
metal such as nitinol and are constructed to normally assume an
"open" configuration. When retracted within the forward end of the
outer catheter 1294, the ribs 1226 of the embolic filter
collapse.
[0083] To use the percutaneous angioplasty device 1210, the inner
catheter is inserted into the outer catheter so that the embolic
filter 1220 is collapsed within the distal end of the device, as
shown in FIG. 33. The outer and inner catheters 1294, 1295 are
inserted together, such as through the femoral artery, over a
guidewire and advanced through the vascular system to a location
wherein the un-inflated angioplasty balloon 1218 resides within the
stenosis. Once location of the angioplasty balloon 1218 within the
stenosis has been verified by suitable medical imaging technology,
the inner catheter is advanced to progress the embolic filter 1220
beyond the forward end of the outer catheter 1294. As the embolic
filter 1220 is freed from the confines of the outer catheter 1294,
the ribs assume their expanded configuration and erect the embolic
filter. Thereafter the angioplasty balloon 1218 may be inflated to
treat the stenosis, and any emboli loosened during the procedure
will be captured by the embolic filter 1220 downstream of the
stenosis.
[0084] When the angioplasty procedure has been completed, the
angioplasty balloon 1218 is deflated, and the embolic filter 1220
is withdrawn back into the forward end of the outer catheter 1294.
The outer and inner catheters 1294, 1295 are then withdrawn
together from the patient.
[0085] In the foregoing embodiment a wire can be substituted for
the inner catheter 1295 as a means for carrying the embolic filter
1220.
[0086] FIGS. 35 and 36 show an angioplasty device 1310 that is
identical to the device 10, with the exception that the filter mesh
1328 extends distally beyond the end of the ribs 1326 and is
attached to the distal end of the distal ring 1324. When the filter
1320 is collapsed, as shown in FIG. 36, a sac 1398 is formed which
helps contain the embolic particles, thereby minimizing the
possibility that the ribs 1326 will squeeze the particles out of
the filter.
[0087] In each of the foregoing examples, it will be appreciated
that an angioplasty balloon is but one means for relieving a
stenosis in a vessel. Stents, mechanical thrombectomy devices, or
other suitable apparatus may be substituted for the angioplasty
balloon and positioned on the catheter at a location proximal to
the embolic filter. Thus any emboli loosened by the stent or
mechanical thrombectomy device will be captured by the embolic
filter in the same manner as described above with respect to the
angioplasty balloon.
[0088] While the foregoing disclosed embodiments comprise filter
ribs of a shape memory metal such as nitinol, it will be
appreciated that similar results can be obtained by using any
suitable resilient material. The ribs would be formed straight,
forced open by the balloon, and return to their normal shape as a
result of the resiliency of the structure. Or, in the case of the
embodiment of FIGS. 33 and 34, the ribs would be initially formed
in an open position, deformed inwardly to fit within the outer
catheter, and return to their normal open position when released
from the confines of the outer catheter.
[0089] Variations in the design of the filter are also
contemplated. For example, while both ends of the ribs 26 of the
filter 20 are mounted to rings 22, 24, it will be appreciated that
the ends of the ribs at the fixed end of the filter can be secured
directly to the catheter shaft.
[0090] It will be appreciated that the present invention permits
the placement of the embolic filter very close to the means for
treating the stenosis. This has the effect of minimizing the
"landing area" of the filter and also permits the protection of
side branches, as shown in FIGS. 22-25.
[0091] Finally, it will be understood that the foregoing
embodiments have been disclosed by way of example, and that other
modifications may occur to those killed in the art without
departing from the scope and spirit of the appended claims. Other
aspects of the invention will be apparent to those skilled in the
art from consideration of the specification and practice of the
invention disclosed herein. It is intended that the specification
and examples be considered as exemplary only, with a true scope and
spirit of the invention being indicated by the following
claims.
* * * * *