U.S. patent number RE46,581 [Application Number 11/027,583] was granted by the patent office on 2017-10-24 for cutting balloon catheter.
This patent grant is currently assigned to Boston Scientific Scimed, Inc.. The grantee listed for this patent is Daniel M. Lafontaine, Kurt M. Laundroche. Invention is credited to Daniel M. Lafontaine, Kurt M. Laundroche.
United States Patent |
RE46,581 |
Lafontaine , et al. |
October 24, 2017 |
Cutting balloon catheter
Abstract
A system for removing matter from a partially or totally
occluded stent includes a cutter that is urged radially outward
toward the inner surface of the stent. Preferably, the cutter has a
hardness that is less than or equal to the hardness of the material
used to make the stent. Aspiration may be provided to remove
portions of the occluding material from the vessel.
Inventors: |
Lafontaine; Daniel M.
(Plymouth, MN), Laundroche; Kurt M. (Snohomish, WA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Lafontaine; Daniel M.
Laundroche; Kurt M. |
Plymouth
Snohomish |
MN
WA |
US
US |
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|
Assignee: |
Boston Scientific Scimed, Inc.
(Maple Grove, MN)
|
Family
ID: |
1000002706304 |
Appl.
No.: |
11/027,583 |
Filed: |
December 30, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
09836957 |
Apr 17, 2001 |
6500186 |
Dec 31, 2002 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/320758 (20130101); A61B 17/3207 (20130101); A61B
17/320725 (20130101); A61B 2017/320716 (20130101); A61B
2017/320733 (20130101); A61B 2017/22061 (20130101); A61F
2/82 (20130101) |
Current International
Class: |
A61B
17/22 (20060101); A61B 17/3207 (20060101); A61F
2/82 (20130101) |
Field of
Search: |
;128/898
;606/159,167,180,168-179,190-200 ;604/92-106 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0 533 511 |
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Mar 1999 |
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EP |
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WO 99/23958 |
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May 1999 |
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WO |
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Primary Examiner: Shay; David
Attorney, Agent or Firm: Seager, Tufte & Wickhem LLP
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A .[.system for removing deposits from a partially or totally
occluded stent.]. .Iadd.balloon catheter.Iaddend., comprising:
.Iadd.a catheter shaft configured to be routed over a
guidewire;.Iaddend. an expandable cutter .[.disposed over a guide
wire.]. .Iadd.coupled to the catheter shaft.Iaddend., the cutter
including a coiled member .Iadd.having a proximal end directly
affixed to a distal end of the catheter shaft and a distal end
directly affixed to a distal bearing through which the guidewire is
routed.Iaddend.; and a balloon disposed within the coiled member
that expands to urge the cutter radially outward, .Iadd.the balloon
being a separate component from the expandable cutter, a proximal
end of the balloon directly affixed to the distal end of the
catheter shaft proximate the proximal end of the coiled member and
a distal end of the balloon directly affixed to the distal bearing
proximate the distal end of the coiled member, .Iaddend.wherein the
balloon is inflated .[.when the cutter is within the occluded stent
to urge the cutter toward an inner wall of the occluded stent, the
expandable cutter being rotatable in the occluded stent to remove
occluding matter.]. .Iadd.with a fluid delivered through the
catheter shaft.Iaddend..
2. The .[.system.]. .Iadd.balloon catheter .Iaddend.of claim 1,
wherein the coiled member is a .[.diamond coated.]. helical
wire.
3. The .[.system.]. .Iadd.balloon catheter .Iaddend.of claim 1,
wherein the coiled member is a flat spring .[.having a sharpened
outer edge.]..
4. The .[.system.]. .Iadd.balloon catheter .Iaddend.of claim 1,
wherein the coiled member is a semi-cylindrical wire .[.having a
sharpened edge.]..
.[.5. A method for removing restenotic tissue from within a stent,
comprising: advancing a cutter into the stent, the cutter being
secured to a drive shaft and including an expandable coil having a
cutting surface, wherein the cutting surface is positioned on the
coil such that the cutting surface does not contact the stent when
removing restenotic tissue from within the stent; rotating the
cutter; and aspirating ablated particles of the restenotic
tissue..].
.Iadd.6. The balloon catheter of claim 1, wherein the cutter is
rotatable to remove occluding matter during use..Iaddend.
.Iadd.7. A medical device, comprising: a catheter shaft having a
proximal and a distal end, the catheter shaft being configured to
be routed over a guidewire; an inflatable balloon having a proximal
end directly affixed to the distal end of the catheter shaft and a
distal end directly affixed to a distal member through which the
guidewire is routed; and a helical cutter disposed over a portion
of the inflatable balloon such that the balloon is disposed within
the helical cutter, the helical cutter being a separate component
from the inflatable balloon, a proximal end of the helical cutter
being directly affixed to the distal end of the catheter shaft
proximate the proximal end of the inflatable balloon and a distal
end of the helical cutter being directly affixed to the distal
member proximate the distal end of the inflatable balloon; wherein
the inflatable balloon is inflated with a fluid delivered through
the catheter shaft to move the helical cutter radially
outward..Iaddend.
.Iadd.8. The medical device of claim 7, wherein the helical cutter
includes an abrasive..Iaddend.
.Iadd.9. The medical device of claim 8, wherein the abrasive is a
diamond coating..Iaddend.
.Iadd.10. The medical device of claim 7, wherein the helical cutter
is a flat spring..Iaddend.
.Iadd.11. The medical device of claim 7, wherein the helical cutter
is a wire..Iaddend.
.Iadd.12. The medical device of claim 7, wherein the helical cutter
is rotatable to remove occluding matter during use..Iaddend.
.Iadd.13. The medical device of claim 7, wherein the distal member
is a distal bearing..Iaddend.
Description
.Iadd.Notice: More than one reissue application has been filed for
the reissue of U.S. Pat. No. 6,500,186. The reissue applications
are application Ser. No. 11/027,583 (the present application) and
Ser. No. 13/368,116, each of which are divisional reissues of U.S.
Pat. No. 6,500,186..Iaddend.
FIELD OF THE INVENTION
The present invention relates to medical devices in general, and in
particular, to rotational atherectomy devices.
BACKGROUND OF THE INVENTION
One of the most common types of vascular diseases afflicting
Americans today involves the narrowing of blood vessels by plaque
or other materials. Left untreated, such narrowed vessels can
contribute to high blood pressure, strokes, or cardiac arrest.
One of the most common techniques for treating a fully or partially
blocked vessel is to bypass the blockage with a healthy vessel
obtained from elsewhere in the body. A less traumatic approach
involves the insertion of a balloon angioplasty device into the
vessel and expanding the balloon to compress the occlusion against
the vessel wall. Another minimally invasive technique is an
atherectomy procedure, where a high-speed cutting device such as
the Rotoblator.TM., produced by SCIMED Life Systems, Inc., the U.S.
assignee of the present invention, is inserted into the vessel and
advances against the occlusion in order to grind it into small
particles that are passed by the body.
In many instances, a physician will place a stent in the area of
the treated occlusion. In the case of balloon angioplasty, stents
operate to prevent the compressed occlusion from springing back to
its former size. For vessels that have undergone an atherectomy
procedure, the stent helps maintain an open passage or lumen
through the vessel.
Regardless of the procedure used, a fair percentage of stents
become re-occluded within a relatively short period of time.
However, the material that occludes the stent is somewhat different
from the occluding material that blocked the vessel in the first
instance. Therefore, techniques used to treat an original occlusion
are not believed to be as effective when treating a re-occluded
stent. Therefore, there is a need for a device and method of
effectively treating re-occluded stents in a manner that does
minimal or no damage to the stent itself.
SUMMARY OF THE INVENTION
The present invention is a system and method for removing occluding
material from a stent that is positioned within a vessel. In one
embodiment of the invention, a rotational cutter is made of a
material having a hardness less than or equal to the hardness of
the material used to make the stent. The cutter has a number of
recessed blades such that the outer surface of the cutter is
relatively smooth and cutting is limited to tissue that enters
channels in which the blades are placed. The cutter is preferably
routed on a guide wire that is shaped such that the cutter is
pressed radially outward against the inner surface of the stent. To
aid in the removal of ablated material that is cut from the stent,
an aspiration system including a catheter coupled to a source of
negative pressure operates to aspirate ablated particles.
In another embodiment of the invention, a cutting mechanism
includes a catheter with a self-expanding stent on the distal end
thereof. One or more knives are secured to the stent such that the
knives are pushed radially outward by the stent. Once the expanding
stent is positioned in an occluded stent, the one or more knives
are extended and rotated to remove occluding material. Ablated
material from the occluded stent is preferably aspirated from the
vessel.
In another embodiment of the invention, a cutting mechanism
includes a helically-wound cutter that surrounds an inflatable
balloon. The balloon is inflated to urge the cutter radially
outward against the inner wall of the stent. Ablated particles
removed from the stent are preferably aspirated from the
vessel.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing aspects and many of the attendant advantages of this
invention will become more readily appreciated as the same become
better understood by reference to the following detailed
description, when taken in conjunction with the accompanying
drawings, wherein:
FIG. 1 shows a system for removing material from an occluded stent
in accordance with one embodiment of the present invention;
FIGS. 2 and 3 illustrate a cutter in accordance with another aspect
of the present invention;
FIG. 4 illustrates a cutter for removing material from an occluded
stent in accordance with yet another embodiment of the present
invention;
FIG. 5 illustrates a helical cutter in accordance with another
aspect of the present invention;
FIGS. 5A-5C illustrate various embodiments of helical cutters in
accordance with other aspects of the present invention; and
FIG. 6 illustrates a system for operating the helical cutter in
accordance with another aspect of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 1 illustrates one embodiment of a system 10 for removing
occluding matter 12 from a stent 14 that is positioned within a
vessel 16 according to the present invention. As indicated above,
the occluding material 12 is typically different from the occluding
material generally associated with arteriosclerosis or other
vascular diseases. Once the stent 14 is positioned in the vessel
12, the material 12 that re-occludes the stent is typically a
smooth-celled growth that may continue to grow until the lumen or
passage through the stent 14 is totally blocked.
To remove the occluding material 12 from the stent, the present
invention includes a cutter 20 that is rotated by a drive shaft 22.
The drive shaft 22 is advanced and rotated by an
advancer/rotational drive 23 at the maximal end of the drive shaft
22. The cutter 20 and the drive shaft 22 are routed within a
catheter 30 that is coupled to a source of negative pressure to
provide a corresponding negative pressure or slight vacuum within
the vessel 16 at the location of the stent. The catheter 30 may
have a mechanism for sealing the catheter within the vessel such as
a self-expanding stent 32 that is covered with an elastomeric
coating such that when the stent 32 expands, the vessel is sealed.
Alternatively, inflatable balloons at the end of the catheter 30 or
other mechanisms may be used to seal the vessel in order to provide
proper aspiration of the ablated particles.
To ensure that the cutter 20 clears a passage with a fairly large
diameter, the cutter 20 is preferably routed over a guide wire 40
that is helical or otherwise shaped to force the cutter 20 toward
the inner surface of the stent 14 when the cutter is advanced over
the guide wire.
In some instances, it may be desirable to deliver a saline solution
or other liquid through the drive shaft 22 and/or the cutter 20 to
provide additional liquid volume in the vessel so that the vessel
16 doesn't collapse during aspiration. Saline and blood aspirated
from the vessel are received in a collecting jar 42 and returned by
a pump 44 to the patient via an intravenous drip or other
mechanism.
In order to prevent damage to the stent, the cutter 20 as shown in
FIG. 2 is preferably made of a material that is soft or softer than
the material from which the stent is made. Typically, the stent 14
is made is made of Nitinol.TM. or stainless steel. Therefore, the
cutter 20 is preferably made of a material having a hardness less
than or equal to Nitinol.TM. or stainless steel. As shown in FIG.
3, the cutter 20 has a number of recessed blades 50 that lie within
corresponding channels 52. The blades 50 are positioned such that
the outer surface of the cutter 20 is relatively smooth and will
not catch or cut the inner surface of the stent 14. However, any
occluding matter 12 that enters or is forced into the channels 52
is cut by the one or more blades 50 as the cutter 20 is rotated by
the drive shaft 22. The channels 52 may be spiralled around the
outer surface of the cutter 20 in order to force ablated material
proximally as the burr is rotated in order to aid aspiration of the
ablated tissue.
FIG. 4 shows an alternative embodiment of a system for removing
occluding matter from a stent. Here, a stent 60 is positioned
within a vessel 62. The stent is shown as being fully blocked by
occluding material 64. To remove the occluding material 64, a
catheter 70 is inserted into the vessel. The catheter 70 has a
self-expanding stent 72 at its distal end that is preferably
covered with an elastomeric or other non-porous material 74 to seal
the vessel when the stent 72 expands. One or more extendable
cutting knives or blades 76, 77 are secured to the stent 72 such
that when the stent is expanded, the one or more knives 76 are
urged radially outward toward the vessel wall. In operation, the
catheter 70 can be placed within or adjacent to the occluded stent
60. The self-expanding stent 72 is allowed to expand such that the
one or more knives 76, 77 are positioned within the stent 60.
Thereafter, the catheter 70, self-expanding stent 72, and one or
more cutting knives 76, 77 are rotated within the stent to remove
portions of the occluding matter 64. Aspiration can be applied to
the catheter 70 to remove portions of the occluding material that
are cut by the one or more cutting knives 76, 77.
To further hold the catheter 70 in position within the stent, a
guide wire 80 has one or more hooks 82 (that may or may not be
barbed) at its distal end that can be implanted into the occluding
matter 64. The guide wire 80 serves an anchor against which the
catheter 70 can be pulled in order to advance the one or more
cutting knives 76, 77 within the occluded stent 60. Once the one or
more cutting knives 76, 77 are rotated 360.degree. in the stent 60,
the guide wire 80 can be further advanced into the occluding
material 64 and the process repeated.
FIG. 5 shows yet another alternative embodiment of a system for
removing occluding matter from a stent in accordance with the
present invention. In this embodiment, a helical cutter 90 extends
around a guide wire 92 that is routed within a catheter 94. The
cutter 90 extends from the end of the catheter 94 to a distal
bearing 96 that is positioned on the guide wire 92. Within the
helical cutter 90 is a balloon 98 .Iadd.(shown in phantom
lines).Iaddend.. The balloon 98 can be inflated with the saline or
other material that is delivered through the catheter 94
.Iadd.(shown by arrows).Iaddend.. Preferably, the catheter 94 is
sealed along its length to prevent loss of the material used to
inflate the balloon. Inflating the balloon 98 urges the helical
cutter 90 radially outward toward the inner surface of a stent.
FIGS. 5A-5C show three of many possible embodiments of the helical
cutter 90. The helical cutter 90 can comprise a generally round
wire 100 that is selectively coated with an abrasive material such
as diamond grit 102 as shown in FIG. 5A. The diamond grit is plated
to a wire selectively such that the grit is not exposed on the
surfaces that contact the stent itself, if the plated wire
momentarily engages the stent, but only cuts deformable restenosis
tissue that deforms in the abrasive.
Alternatively, as shown in FIG. 5B, the helical cutter 90 can
comprise a relatively flat spring 104 having an outer edge 106 that
is sharpened to provide a cutting surface. The material used to
make the flat spring 104 preferably has a hardness that is less
than or equal to the hardness of the material used to make the
stent to be cleared.
Alternatively, as shown in FIG. 5C, the helical cutter 90 can
comprise a cutaway tube, such as a hypotube, having a sharpened
outer edge 110. The tube is wound into a helical coil around the
guide wire. The material used to make the tube should have a
hardness less or equal to the hardness of the material used to make
the stent.
FIG. 6 shows how a helical cutter 90 of a type shown in FIG. 5 is
used within a vessel. The helical cutter 90 is positioned within a
partially or totally occluded stent 120 that is within a vessel
122. A catheter 130 is advanced into the vessel 122 and a sealing
mechanism such as one or more balloons 134 at the distal end of the
catheter is used to seal the vessel. A catheter 94 that contains
the helical cutter 90 is then advanced through the catheter 94. The
helical cutter 90 is expanded radially outward once it is within
the stent 120 by inflating the balloon 98. The catheter 94 is then
rotated by a prime mover such as gas turbine or an electric motor
(not shown) at the proximal end of the catheters 94 and 130.
Rotation of the helical cutter 90 removes the occluding material
124 from the stent 120. In addition, aspiration can be provided to
the catheter 130 and/or 94 to remove portions of the ablated,
occluding material 124. The aspirated material can be removed from
the vessel using a pump 140 and a filter 144 before the aspirated
liquid is returned to the patient.
While the preferred embodiment of the invention has been
illustrated and described, it will be appreciated that various
changes can be made therein without departing from the spirit and
scope of the invention. It is therefore intended that the scope of
the invention be determined from the following claims and
equivalents thereto.
* * * * *