U.S. patent application number 09/835017 was filed with the patent office on 2001-11-29 for ica angioplasty with cerebral protection.
This patent application is currently assigned to Arteria Medical Science, Inc.. Invention is credited to Connors, John J. III.
Application Number | 20010047184 09/835017 |
Document ID | / |
Family ID | 27533785 |
Filed Date | 2001-11-29 |
United States Patent
Application |
20010047184 |
Kind Code |
A1 |
Connors, John J. III |
November 29, 2001 |
ICA angioplasty with cerebral protection
Abstract
A method of performing an operation including angioplasty of the
internal carotid artery includes blocking blood flow in the
internal carotid artery, performing the angioplasty while the blood
flow is blocked in the internal carotid artery, and reversing flow
in the internal carotid artery after the angioplasty has been
performed to wash material loosened during the angioplasty out of
the internal carotid artery. Normal flow in the internal carotid
artery is restored after the loosened material is washed out of the
internal carotid artery.
Inventors: |
Connors, John J. III; (New
Orleans, LA) |
Correspondence
Address: |
FISH & NEAVE
1251 AVENUE OF THE AMERICAS
50TH FLOOR
NEW YORK
NY
10020-1105
US
|
Assignee: |
Arteria Medical Science,
Inc.
San Francisco
CA
94129
|
Family ID: |
27533785 |
Appl. No.: |
09/835017 |
Filed: |
April 13, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09835017 |
Apr 13, 2001 |
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09018365 |
Feb 4, 1998 |
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6295989 |
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60038040 |
Feb 6, 1997 |
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60037226 |
Feb 6, 1997 |
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60038039 |
Feb 6, 1997 |
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60037225 |
Feb 6, 1997 |
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Current U.S.
Class: |
606/194 ;
604/101.04 |
Current CPC
Class: |
A61B 2017/22054
20130101; A61B 2017/22001 20130101; A61B 17/22 20130101 |
Class at
Publication: |
606/194 ;
604/101.04 |
International
Class: |
A61M 029/00; A61B
019/00 |
Goverment Interests
[0002] Not applicable
Claims
1. A method of performing an operation including angioplasty of the
internal carotid artery comprising the following steps: (a)
blocking blood flow in the internal carotid artery; (b) performing
the angioplasty while the blood flow is blocked in the internal
carotid artery; (c) reversing flow in the internal carotid artery
after the angioplasty has been performed to wash material loosened
during the angioplasty out of the internal carotid artery; (d)
restoring normal flow in the internal carotid artery.
2. A method of performing an operation including angioplasty of the
internal carotid artery comprising the following steps: (a)
blocking flow in the common carotid artery, thus causing retrograde
blood flow in the internal carotid artery; (b) blocking flow in the
internal carotid artery, distal of the stenosis; (c) performing
angioplasty on the stenosis; (d) unblocking flow in the internal
carotid artery, thus allowing retrograde blood flow in the internal
carotid artery into the external carotid artery; and (e) unblocking
flow in the common carotid artery.
3. Apparatus for performing angioplasty, including: (a) a guide
catheter having a first occlusion balloon adjacent a distal end
thereof, the first occlusion balloon being sized to stop blood flow
in a first artery; (b) a wire which can be advanced through the
guide catheter and which includes a second occlusion balloon
adjacent a distal end thereof the second occlusion balloon being
sized to stop blood flow in a second artery; (c) means for
selectively inflating and deflating the first balloon; (d) means
for selectively inflating and deflating the second balloon; (e) an
angioplasty balloon catheter which can be advanced through the
guide catheter and along the wire to the site of a stenosis in the
second artery.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority of my U.S. Provisional
Patent Application Ser. Nos. 60/038,040; 60/037,226; 60/037,225;
and 60/038,039, all filed Feb. 5, 1997 and all incorporated herein
by reference. This application also claims priority of my U.S.
Provisional Patent Application also filed on Feb. 6, 1997 with the
four above-mentioned provisional patent applications and entitled
"ICA ANGIOPLASTY WITH CEREBRAL PROTECTION" and bearing attorney
docket number V97004US (16064/4). That application is also
incorporated herein by reference.
REFERENCE TO A "MICROFICHE APPENDIX"
[0003] Not applicable
BACKGROUND OF THE INVENTION
[0004] 1. Field of the Invention
[0005] The present invention relates to internal carotid artery
(ICA) angioplasty with cerebral protection. More particularly, the
present invention relates to a system for conducting angioplasty
while minimizing risk of strokes.
[0006] 2. General Background of the Invention
[0007] When angioplasties are performed, sometimes plaque gets
dislodged and travels into the brain, sometimes causing
strokes.
[0008] The following references are hereby incorporated by
reference: U.S. Pat. Nos. 3,726,269; 4,033,331; 4,169,464;
4,573,966; 4,925,445; 4,935,017; 5,120,323; 5,163,906; 5,199,951;
5,203,776; 5,215,540; 5,219,355; 5,267,982; 5,290,229; 5,304,131;
5,342,306; 5,348,545; 5,368,566; 5,389,090; 5,458,574; 5,462,529;
5,480,380; 5,484,412; European Patent Specification Publication
Nos. 0 339 799 B1 and 0 277 366 A1 and PCT International
Application Publication No. WO 96/26758.
BRIEF SUMMARY OF THE INVENTION
[0009] The apparatus of the present invention solves the problems
confronted in the art in a simple and straightforward manner. What
is provided is a method of performing an operation including
angioplasty of the internal carotid artery comprising the following
steps: (a) blocking blood flow in the internal carotid artery; (b)
performing the angioplasty while the blood flow is blocked in the
internal carotid artery; (c) reversing flow in the internal carotid
artery after the angioplasty has been performed to wash material
loosened during the angioplasty out of the internal carotid artery;
and (d) restoring normal flow in the internal carotid artery.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0010] For a further understanding of the nature, objects, and
advantages of the present invention, reference should be had to the
following detailed description, read in conjunction with the
following drawings, wherein like reference numerals denote like
elements and wherein:
[0011] In FIG. 1 initial placement of the flow control guide
catheter 111 has been made, but the balloon 118 has not been
inflated; antegrade flow is still present in the common carotid
artery 61 and internal and external carotid arteries 71, 72.
[0012] In FIG. 2, inflation of the guide catheter balloon 118 stops
flow in the common carotid artery 61 and reverses flow in the
internal carotid artery 71. The high pressure intracranial vascular
system will supply the low pressure sump of the external carotid
artery 72.
[0013] In FIG. 3, while flow reversal is occurring, a soft tipped
"wire with a balloon" 80 is advanced safely through the lesion 40;
any material displaced during passage will flow in a retrograde
course out the external carotid artery 72.
[0014] In FIG. 4, the distal balloon 91 is inflated, stopping all
flow in the internal carotid artery 71.
[0015] In FIG. 5, the guide catheter balloon 111 is deflated,
washing out the stagnant blood and debris in the region of the
stenosis 40.
[0016] In FIG. 6, both balloons 81, 118 are inflated and the
angioplasty catheter 90 is delivered safely to its intended
location.
[0017] In FIG. 7, the angioplasty is performed while flow is
arrested in the common carotid 61 and internal carotid 71
arteries.
[0018] In FIG. 8, after initial angioplasty, a stent 50 is
delivered into the closed system, again with both the distal and
proximal flow occluded.
[0019] In FIG. 9, the stent 50 is safely deployed under flow
arrest.
[0020] In FIG. 10, the angioplasty catheter 90 is withdrawn,
leaving the stent 50 in place with flow arrested in the carotid
arteries 61, 71, 72.
[0021] In FIG. 11, the distal balloon 81 is deflated, allowing
reversal of flow again in the internal carotid artery 71. This
allows any retained material to be washed into the external carotid
artery 72 again.
[0022] In FIG. 12, the distal balloon 81 is re-inflated, again
stopping flow in the internal carotid artery 71.
[0023] In FIG. 13, the proximal balloon 118 is deflated. This
allows high pressure antegrade flow into the external carotid
artery 72 and allows contrast injection through the inner lumen of
the guide catheter 111. Evaluation of the result of the
angioplasty/stent is now possible. Any retained material is now
forcefully washed out of the system into the external carotid
artery 72.
[0024] In FIG. 14, the proximal balloon 118 is again inflated.
[0025] In FIG. 15, the distal balloon 81 is deflated. While flow is
again reversed in the internal carotid artery 71, the distal
wire/balloon 80 is safely withdrawn, again with no chance of
dislodging any material into the intracranial flow.
[0026] In FIG. 16, once the inner wire/balloon 80 has been
withdrawn, the guide catheter balloon 118 is deflated, allowing
final contrast injection through the guide catheter lumen to
evaluate the results.
DETAILED DESCRIPTION OF THE INVENTION
[0027] This is also the technique of choice for internal carotid
artery stenting due to its excellent cerebral protection.
[0028] 1. Select the common carotid artery 61 using a selective
diagnostic cerebral catheter; evaluate the path available to the
angioplasty site.
[0029] 2. Exchange the diagnostic catheter for a flow control guide
catheter utilizing a safe "neuro" exchange wire.
[0030] (Instead of the first two steps listed above, one could
instead use the flow control guide catheter 111 of the present
invention which is a modified version of the guide catheter
disclosed in the attached provisional patent application entitled
"Guide Catheter System", which modified version is discussed
below).
[0031] 3. Inflate the balloon 118 on the flow control catheter 111,
occluding flow in the common carotid artery 61 and resulting in
reversal of flow in the internal carotid artery 71 or cessation of
flow (at the very least).
[0032] 4. Load a micro-occlusion balloon catheter 80 containing a
microwire through the selected angioplasty balloon catheter 90.
(This will necessitate the placement of a microballoon on a
microcatheter after loading, or the use of a proprietary device,
currently in development.) Carefully navigate the micro-occlusion
balloon 81 past the stenosis 40 with the angioplasty balloon 91
remaining proximal within the guide catheter lumen. The occluded
common carotid artery 61 thus protects this initial dangerous
crossing.
[0033] 5. Before inflating the distal balloon 81, aspirate through
the guide catheter 111 to remove any debris dislodged during the
initial crossing of the plaque 40; any remainder will flow in a
retrograde direction into the external carotid artery 72.
[0034] 6. Inflate the distal micro-occlusion balloon 81, stopping
all flow in the internal carotid artery 71.
[0035] 7. Deflate the guide catheter occlusion balloon 118; this
now allows the previously stagnant blood in the common carotid
artery 61 to wash out into the external carotid artery 72 and
refreshes this territory. It also further washes out the
potentially disturbed stenotic region, with debris again going into
the external carotid artery 72.
[0036] 8. Reinflate the guide catheter occlusion balloon 118,
ceasing flow in the common carotid artery 61.
[0037] 9. Advance the angioplasty catheter 90 over the
wire/micro-occlusion balloon 80 into place and perform the
angioplasty (and stent placement, if applicable).
[0038] 10. Deflate the angioplasty balloon 91 and withdraw this
catheter 90.
[0039] 11. Slowly infuse contrast through the guide catheter 111 to
visualize the angioplasty site.
[0040] 12. Repeat if necessary (and place stent if necessary).
[0041] 13. Open the external lumen of the guide catheter 111 to the
air.
[0042] 14. Deflate the distal occlusion balloon 81 and let
backbleeding occur for a few seconds, both into the external
carotid artery 72 and out the guide catheter 111.
[0043] 15. Close the external drainage of the guide catheter 111;
let the retrograde flow from the internal carotid artery 71
continue into the external carotid artery 72. Perfuse with ReoPro,
etc., as indicated.
[0044] 16. Perform repeat angiogram to evaluate the status of the
angioplasty site by injecting through the guide catheter lumen,
slowly.
[0045] 17. Remove all indwelling catheters/balloons except for the
guide catheter 111.
[0046] 18. Deflate the guide catheter balloon 118 and perform final
angioplasty site evaluation.
[0047] 19. Perform final evaluation of intracranial cerebral
vasculature.
[0048] The preferred guide catheter system for getting the balloon
catheter 111 to its intended location is the guide catheter system
disclosed in the attached U.S. Provisional Patent Application Ser.
No. 60/037,225 entitled "Guide Catheter System", but modified to
include a balloon 118 on the guide catheter 111 disclosed herein.
Thus, one could use the system disclosed therein, replacing the
catheter 11 disclosed therein with balloon catheter 111, which is
the same as catheter 11 except that catheter 111 also includes a
balloon 118 and means for inflating and deflating balloon 118.
[0049] Parts list
[0050] 40 stenosis
[0051] 50 stent (made of stainless steel and could be, e.g., a
stent commercially available from Palmaz)
[0052] 61 selected vessel (common carotic artery)
[0053] 62 intended location of tip 112 of catheter 111
[0054] 71 internal carotid artery
[0055] 72 external carotid artery
[0056] 80 wire with balloon (e.g., a wire with balloon commercially
available from Johnson & Johnson as part no. P104)
[0057] 81 balloon of wire 80
[0058] 90 angioplasty catheter (e.g., a Diamond TM brand
angioplasty catheter commercially available from Boston Scientific
having a balloon which is 6 mm in diameter by 20 mm long)
[0059] 91 balloon of angioplasty catheter
[0060] 110 guide catheter system
[0061] 111 guide catheter (e.g., a catheter commercially available
as FasGuide made by Target Therapeutic)
[0062] 112 soft, atraumatic tip of guide catheter 11
[0063] 113 very stiff proximal shaft of guide catheter 111
[0064] Enclosed is an appendix with more information about the
present invention.
[0065] All measurements disclosed herein are at standard
temperature and pressure, at sea level on Earth, unless indicated
otherwise. All materials used or intended to be used in a human
being are biocompatible, unless indicated otherwise.
[0066] The foregoing embodiments are presented by way of example
only; the scope of the present invention is to be limited only by
the following claims.
* * * * *