U.S. patent application number 11/139462 was filed with the patent office on 2005-10-13 for delivery and recovery system for embolic protection system.
Invention is credited to Andrews, Christopher C., Boyle, William J., Correa, Sergio, Denison, Andy E., Huter, Benjamin C., Huter, Scott J., Jordan, Brad, Muller, Paul, Neale, Paul V., Patel, Samir, Stack, Richard.
Application Number | 20050228439 11/139462 |
Document ID | / |
Family ID | 34827749 |
Filed Date | 2005-10-13 |
United States Patent
Application |
20050228439 |
Kind Code |
A1 |
Andrews, Christopher C. ; et
al. |
October 13, 2005 |
Delivery and recovery system for embolic protection system
Abstract
A system for enabling the insertion and removal of an embolic
protection device, for capturing and retaining embolic debris which
can be created during the performance of a therapeutic
interventional procedure in a stenosed or occluded region of a
blood vessel. The system, in an embodiment thereof, is capable of
enabling at least one operator to control the delivery and removal
of an embolic protection device to a position in a patient's
vasculature distal to an interventional procedure site, to enable
the exchange of the delivery and recovery system. The system, in
another embodiment thereof, includes a delivery system and a
recovery system which are capable of enabling the delivery and
recovery of an embolic protection device so as to maintain a
clinically acceptable profile and flexibility through the patient's
vasculature.
Inventors: |
Andrews, Christopher C.;
(Murrieta, CA) ; Boyle, William J.; (Fallbrook,
CA) ; Correa, Sergio; (Encinitas, CA) ;
Denison, Andy E.; (Temecula, CA) ; Huter, Benjamin
C.; (Murrieta, CA) ; Huter, Scott J.;
(Temecula, CA) ; Jordan, Brad; (Wildomar, CA)
; Muller, Paul; (San Carlos, CA) ; Neale, Paul
V.; (San Diego, CA) ; Patel, Samir; (Fremont,
CA) ; Stack, Richard; (Chapel Hill, NC) |
Correspondence
Address: |
THOMAS MAJCHER
Fulwider Patton Lee and Utecht LLP
606 Center Dr
Los Angeles
CA
90045
US
|
Family ID: |
34827749 |
Appl. No.: |
11/139462 |
Filed: |
May 26, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11139462 |
May 26, 2005 |
|
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09872692 |
Jun 1, 2001 |
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6929652 |
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Current U.S.
Class: |
606/200 |
Current CPC
Class: |
A61F 2230/0006 20130101;
A61F 2/011 20200501; A61F 2230/008 20130101; A61F 2002/018
20130101 |
Class at
Publication: |
606/200 |
International
Class: |
A61M 029/00 |
Claims
We claim:
1. A system for enabling the delivery of an embolic protection
device to a position in a patient's vasculature distal to an
interventional procedure site, for deployment of the embolic
protection device, wherein the delivery system is adapted to
maintain a clinically acceptable profile and flexibility during the
delivery and removal thereof through the patient's vasculature,
comprising: a guide wire, including a distal end, adapted to be
positioned within the blood vessel and to extend to a position
distal to the interventional procedure site, and to include an
embolic protection device mounted on the distal end thereof; and a
delivery sheath, including a distal end, wherein the delivery
sheath has a lumen therein extending in the delivery sheath to the
distal end thereof, and wherein the guide wire and the embolic
protection device are adapted to extend in and through the lumen,
the delivery sheath and the guide wire are adapted to enable the
embolic protection device to be delivered and deployed distal to
the interventional procedure site, and the delivery sheath
comprises dimensions and materials adapted to provide a low
profile, flexibility for enabling tracking thereof through the
patient's vasculature, and rigidity for enabling pushing thereof
through the patient's vasculature, so as to maintain a clinically
acceptable profile and flexibility during the delivery and removal
thereof through the patient's vasculature.
2. The system of claim 1, wherein the delivery sheath includes a
tip at the distal end thereof, adapted to be necked for providing a
profile close to the guide wire, to inhibit kinking of the guide
wire during the delivery and removal of the delivery sheath.
3. The system of claim 1, wherein the delivery sheath includes a
main shaft, adapted to provide the low profile, flexibility, and
rigidity.
4. The system of claim 1, further comprising a system for enabling
the recovery of the embolic protection device from the position in
the patient's vasculature distal to the interventional procedure
site, for removal of the embolic protection device, wherein the
recovery system is adapted to maintain a clinically acceptable
profile and flexibility during the delivery and removal of the
recovery system through the patient's vasculature, and wherein the
recovery system includes an inner catheter, including a distal end,
wherein the inner catheter has a lumen therein extending in the
inner catheter to the distal end thereof, and wherein the inner
catheter is adapted to extend over the guide wire, and the distal
end of the inner catheter is adapted to be positionable adjacent
the embolic protection device, and wherein the inner catheter
comprises dimensions and materials adapted to enable a smooth
transition for movement thereof along the guide wire, to inhibit
kinking of the guide wire during the delivery and removal of the
inner catheter, and to maintain a clinically acceptable profile and
flexibility during the delivery and removal thereof through the
patient's vasculature.
5. The system of claim 2, wherein the tip of the delivery sheath is
comprised of material adapted to be soft, to inhibit trauma to the
patient's vasculature.
6. The system of claim 5, wherein the main shaft of the delivery
sheath is comprised of PeBax, of about 72 Durometer.
7. The system of claim 4, wherein the recovery system further
includes an outer catheter, including a distal end, wherein the
outer catheter has a lumen therein extending in the outer catheter
to the distal end thereof, the outer catheter is adapted to extend
over the inner catheter, and the outer catheter comprises
dimensions and materials adapted to enable a smooth transition for
movement thereof along the inner catheter, to enable the capturing
of the embolic protection device, and to inhibit trauma to the
patient's vasculature, so as to maintain a clinically acceptable
profile and flexibility during the delivery and removal thereof
through the patient's vasculature.
8. The system of claim 5, wherein the tip of the delivery sheath is
comprised of a compound including PeBax, of about 40 Durometer, and
bismuth.
9. The system of claim 7, wherein the outer catheter includes a
main shaft, adapted to enable the smooth transition, and to inhibit
trauma.
10. The system of claim 7, wherein the outer catheter includes a
distal end, and a tip at the distal end, adapted to enable the
smooth transition, and to capture the embolic protection device,
and comprised of material adapted to be soft, to inhibit trauma to
the patient's vasculature.
11. The system of claim 9, wherein the main shaft of the outer
catheter is comprised of a high density PE.
12. The system of claim 10, wherein the tip of the outer catheter
is comprised of a compound including PeBax, of about 40 Durometer,
and bismuth.
13. A method of enabling at least one operator to control the
delivery of an embolic protection device to a position in a
patient's vasculature distal to an interventional procedure site
for deployment of the embolic protection device, to enable the
operator to control the removal of the delivery system from the
patient's vasculature for the exchange of the delivery system, and
to enable control of the position of a deployed embolic protection
device within the patient's vasculature during an exchange of
interventional devices, in a system which comprises a guide wire,
including a distal end, adapted to be positioned within the blood
vessel and to extend to a position distal to the interventional
procedure site, and to include an embolic protection device mounted
on the distal end thereof, and a catheter, including a distal end,
wherein the catheter has a lumen therein extending in the catheter
to the distal end thereof, and wherein the guide wire and the
embolic protection device are adapted to extend in and through the
lumen, the catheter and the guide wire are adapted to enable the
embolic protection device to be delivered and deployed distal to
the interventional procedure site, and the catheter includes a
manipulation-enabling element for enabling at least one operator to
manipulate the guide wire and the catheter independently so as to
enable removal of the catheter from the patient's vasculature,
wherein the method comprises: the at least one operator: inserting
the guide wire with the embolic protection device mounted on the
distal end thereof and the catheter into the blood vessel to the
position distal to the interventional procedure site; deploying the
embolic protection device at the position thereof distal to the
interventional procedure site; detaching the catheter from the
embolic protection device; and manipulating the guide wire and the
catheter independently so as to control the removal of the catheter
from the patient's vasculature.
14. The method of claim 13, further comprising a system for
enabling the at least one operator to control the recovery of the
embolic protection device, from the delivered and deployed position
thereof, for the exchange of the recovery system, further
comprising inserting the catheter through the patient's vasculature
to a position adjacent the embolic protection device, capturing the
embolic protection device, and manipulating the guide wire and the
catheter independently so as to control the removal of the catheter
and the embolic protection device from the patient's
vasculature.
15. A method of enabling the delivery of an embolic protection
device to a position in a patient's vasculature distal to an
interventional procedure site, for deployment of the embolic
protection device, in a delivery system which is adapted to
maintain a clinically acceptable profile and flexibility during the
delivery and removal thereof through the patient's vasculature,
wherein the delivery system comprises a guide wire, including a
distal end, adapted to be positioned within the blood vessel and to
extend to a position distal to the interventional procedure site,
and to include an embolic protection device mounted on the distal
end thereof, and a delivery sheath, including a distal end, wherein
the delivery sheath has a lumen therein extending in the delivery
sheath to the distal end thereof, and wherein the guide wire and
the embolic protection device are adapted to extend in and through
the lumen, the delivery sheath and the guide wire are adapted to
enable the embolic protection device to be delivered and deployed
distal to the interventional procedure site, and the delivery
sheath comprises dimensions and materials adapted to provide a low
profile, flexibility for enabling tracking thereof through the
patient's vasculature, and rigidity for enabling pushing thereof
through the patient's vasculature, so as to maintain a clinically
acceptable profile and flexibility during the delivery and removal
thereof through the patient's vasculature, and wherein the method
comprises: extending the guide wire with the embolic protection
device mounted on the distal end thereof through the lumen in the
delivery sheath such that the embolic protection device is
positioned at the tip of the delivery sheath; delivering the
delivery sheath through the patient's vasculature, so as to enable
delivery of the embolic protection device for deployment thereof at
the position distal to the interventional procedure site, including
enabling the delivery sheath to maintain a clinically acceptable
profile and flexibility during delivery thereof; and removing the
delivery sheath through the patient's vasculature, including
enabling the delivery sheath to maintain a clinically acceptable
profile and flexibility during removal thereof.
16. The method of claim 15, further comprising a system for
enabling the recovery of the embolic protection device from the
position in the patient's vasculature distal to the interventional
procedure site, for removal of the embolic protection device,
wherein the recovery system is adapted to maintain a clinically
acceptable profile and flexibility during the delivery and removal
of the recovery system through the patient's vasculature, and
wherein the recovery system includes an inner catheter, including a
distal end, wherein the inner catheter has a lumen therein
extending in the inner catheter to the distal end thereof, the
inner catheter is adapted to extend over the guide wire, and the
distal end of the inner catheter is adapted to be positionable
adjacent the embolic protection device, and the inner catheter
comprises dimensions adapted to enable a smooth transition for
movement thereof along the guide wire, to inhibit kinking of the
guide wire during the delivery and removal of the inner catheter,
and to maintain a clinically acceptable profile and flexibility
during the delivery and removal thereof through the patient's
vasculature, further comprising delivering the inner catheter
through the patient's vasculature to the position adjacent the
proximal end of the embolic protection device, including
maintaining a clinically acceptable profile and flexibility during
delivery thereof.
17. The method of claim 16, wherein the recovery system further
includes an outer catheter, including a distal end, wherein the
outer catheter has a lumen therein extending in the outer catheter
to the distal end thereof, the outer catheter is adapted to extend
over the inner catheter, and the outer catheter comprises
dimensions and materials adapted to enable a smooth transition for
movement thereof along the inner catheter, to enable the capturing
of the embolic protection device, and to inhibit trauma to the
patient's vasculature, so as to maintain a clinically acceptable
profile and flexibility during the delivery and removal thereof
through the patient's vasculature, further comprising delivering
the outer catheter through the patient's vasculature so as to
extend along the inner catheter and enclose the embolic protection
device therein, including maintaining a clinically acceptable
profile and flexibility during delivery thereof, and removing the
outer catheter through the patient's vasculature with the inner
catheter and the embolic protection device enclosed therein,
including maintaining a clinically acceptable profile and
flexibility during removal thereof.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This is a divisional application of co-pending application
Ser. No. 09/872,692, filed Jun. 1, 2001, whose contents are hereby
incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to improvements in
embolic protection systems and methods. In particular, it relates
to an improved system and method for enabling at least one operator
to effectively deliver an embolic protection device to a position
in a patient's vasculature distal to an interventional procedure
site. The deployment of the embolic protection device is enabled so
as to filter the blood in a blood vessel, to capture embolic
material that may be created and released into the bloodstream
during the performance of the interventional procedure in a
stenosed or occluded region of a blood vessel. The invention also
enables the operator to efficiently remove the embolic protection
device from the interventional procedure site with the captured
embolic material therein.
[0003] The present invention further particularly relates to an
improved system and method for maintaining a clinically acceptable
profile and flexibility during the delivery and removal of the
embolic protection device through the patient's vasculature. The
systems and methods of the present invention are particularly
useful when performing balloon angioplasty, stenting procedures,
laser angioplasty or atherectomy in critical vessels, such as the
carotid, renal, and saphenous vein graft arteries, where the
release of embolic debris into the bloodstream could possibly
occlude the flow of oxygenated blood to the brain or other vital
organs which can cause devastating consequences to the patient.
[0004] A variety of non-surgical interventional procedures have
been developed over the years for opening stenosed or occluded
blood vessels in a patient caused by the build up of plaque or
other substances on the walls of the blood vessel. Such procedures
usually involve the percutaneous introduction of the interventional
device into the lumen of the artery, usually through a catheter.
One widely known and medically accepted procedure is balloon
angioplasty in which an inflatable balloon is introduced within the
stenosed region of the blood vessel to dilate the occluded vessel.
The balloon catheter is initially inserted into the patient's
arterial system and is advanced and manipulated into the area of
stenosis in the artery. The balloon is inflated to compress the
plaque and press the vessel wall radially outward to increase the
diameter of the blood vessel.
[0005] Another procedure is laser angioplasty which utilizes a
laser to ablate the stenosis by super heating and vaporizing the
deposited plaque. Atherectomy is yet another method of treating a
stenosed blood vessel in which a cutting blade is rotated to shave
the deposited plaque from the arterial wall. A vacuum catheter may
be used to capture the shaved plaque or thrombus from the blood
stream during this procedure.
[0006] In another widely practiced procedure, the stenosis can be
treated by placing a device known as a stent into the stenosed
region to hold open and sometimes expand the segment of the blood
vessel or other arterial lumen. Stents are particularly useful in
the treatment or repair of blood vessels after a stenosis has been
compressed by percutaneous transluminal coronary angioplasty
(PTCA), percutaneous transluminal angioplasty (PTA) or removal by
atherectomy or other means. Stents are usually delivered in a
compressed condition to the target site, and then are deployed at
the target location into an expanded condition to support the
vessel and help maintain it in an open position.
[0007] In the past, stents typically have fallen into two general
categories of construction. The first type of stent is expandable
upon application of a controlled force, often through the inflation
of the balloon portion of a dilatation catheter which, upon
inflation of the balloon or other expansion means, expands the
compressed stent to a larger diameter to be left in place within
the artery at the target site. The second type of stent is a
self-expanding stent formed from, for example, shape memory metals
or super-elastic nickel-titanum (NiTi) alloys, which will
automatically expand from a compressed state when the stent is
advanced out of the distal end of the delivery catheter into the
body lumen. Such stents manufactured from self-expandable materials
allow for phase transformations of the material to occur,
contributing to the expansion and contraction of the stent.
[0008] The above non-surgical interventional procedures, when
successful, avoid the necessity of major surgical operations.
However, there is one common problem associated with all of these
non-surgical procedures, namely, the potential release of embolic
debris into the bloodstream which can occlude distal vasculature
and cause significant health problems to the patient. For example,
during deployment of a stent, it is possible that the metal struts
of the stent can cut into the stenosis and shear off pieces of
plaque which become embolic debris that can travel downstream and
lodge somewhere in the patient's vascular system. Pieces of plaque
material can sometimes dislodge from the stenosis during a balloon
angioplasty procedure and become released into the bloodstream.
Additionally, while complete vaporization of plaque is the intended
goal during a laser angioplasty procedure, particles are not always
fully vaporized and may enter the bloodstream.
[0009] When any of the above-described procedures are performed for
example in the carotid arteries, the release of emboli into the
circulatory system can be extremely dangerous to the patient.
Debris that is carried by the bloodstream to distal vessels of the
brain may cause these cerebral vessels to occlude, resulting in a
stroke, and in some cases, death. Therefore, although carotid
percutaneous transluminal angioplasty has been performed in the
past, the number of procedures performed has been limited due to
the justifiable fear of causing an embolic stroke should embolic
debris enter the bloodstream and block vital downstream blood
passages.
[0010] Medical devices have been developed to attempt to deal with
the problem created when debris or fragments enter the circulatory
system following treatment utilizing any one of the
above-identified procedures. One approach which has been attempted
is the cutting of any debris into minute sizes which pose little
chance of becoming occluded in major vessels within the patient's
vasculature. However, it is often difficult to control the size of
the fragments which are formed, and the potential risk of vessel
occlusion still exists, making such procedures in the carotid
arteries a high-risk proposition.
[0011] Other techniques which have been developed to address the
problem of removing embolic debris include the use of catheters
with a vacuum source which provides temporary suction to remove
embolic debris from the bloodstream. However, as mentioned above,
there have been complications with such systems since the vacuum
catheter may not always remove all of the embolic material from the
bloodstream, and a powerful suction could cause problems to the
patient's vasculature.
[0012] Further techniques which have had some limited success
include the placement of an embolic protection device such as a
filter or trap downstream from the treatment site to capture
embolic debris before it reaches the smaller blood vessels
downstream. Such embolic protection devices are adapted to enable
the filtering of embolic debris which may be released into the
bloodstream during the treatment to the vessel, and yet allow a
sufficient amount of oxygenated blood to flow past the device to
supply vital organs downstream from the treatment site.
[0013] However, there have been problems associated with embolic
protection devices, particularly during the insertion, expansion,
deployment, and removal of the embolic protection device within the
blood vessel. The manipulation of the guide wire and the catheter
employed in the insertion and removal of the embolic protection
device usually requires two operators, one for manipulating the
guide wire, and one for manipulating the catheter. This can
sometimes prove to be a somewhat inefficient and inconvenient
method for inserting and removing filtering systems. Also, a long
guide wire was required previously for the delivery and removal of
the embolic protection device, since the guide wire had to be held
until the entire catheter was removed from the body, so that the
guide wire could be grabbed as it exited the body and the catheter
could be removed from the guide wire. Further, very substantial
pullback force on the guide wire and catheter was required, due to
the operation of frictional forces and the interaction thereof.
Also, the insertion and removal of embolic protection devices
through a patient's vasculature, if not properly implemented,
subjected the patient's vasculature to potential trauma and would
interfere with the treatment of the stenosis while increasing the
likelihood of damage thereto.
[0014] Therefore, the present invention provides improved systems
and methods for treating stenosis in blood vessels which enable at
least one operator to manipulate the guide wire and the catheter,
so as to efficiently and effectively deliver an embolic protection
device to a position distal to an interventional procedure site for
deployment thereof. The operator also can remove the embolic
protection device with captured embolic material therein from the
interventional procedure site. The improved systems and methods of
the present invention further enable the treatment of a stenosis in
blood vessels while maintaining a clinically acceptable profile and
flexibility during the delivery and removal of the embolic
protection device through the patient's vasculature. Moreover, the
systems and methods are adapted to be relatively easy for a
physician to use, while enabling the effective delivery and
recovery of a filtering system capable of removing embolic debris
released into the bloodstream. The inventions disclosed herein
satisfy these and other needs.
SUMMARY OF THE INVENTION
[0015] The present invention, in general, provides a system and
method for the insertion and removal of a filtering system for
capturing and retaining embolic debris from a blood vessel. The
embolic debris may be created during the performance of a
therapeutic interventional procedure, such as a balloon angioplasty
or stenting procedure. The filtering system is adapted to prevent
the embolic debris from lodging and blocking blood vessels
downstream from the interventional site. The present invention is
particularly useful for enabling an interventional procedure to be
performed in vital arteries, such as the carotid arteries, in which
critical downstream blood vessels can become blocked with embolic
debris, including the main blood vessels leading to the brain or
other vital organs. As a result, the present invention provides the
physician with a higher degree of confidence in the efficient
delivery and recovery of a filtering system for the collection and
removal of embolic debris from the blood vessel when performing
high-risk interventional procedures.
[0016] The present invention enables a filtering system to be
deployed in the blood vessel at a location distal to the area of
treatment in the interventional procedure site. It also enables the
blood to pass therethrough to enable blood to flow past the filter.
It further enables the blood to be filtered to capture and retain
any embolic debris which may be created during the interventional
procedure.
[0017] More particularly, for example, in an embodiment of the
present invention, a system is adapted to enable at least one
operator to control the delivery of an embolic protection device to
a position in a patient's vasculature distal to an interventional
procedure site, for deployment of the embolic protection device.
The present invention also enables the operator to control the
removal of the delivery system from the patient's vasculature, to
enable the exchange of the delivery and recovery system. It further
enables the operator to control the position of a deployed embolic
protection device within the patient's vasculature during an
exchange of interventional devices.
[0018] The delivery system includes a guide wire, having a distal
end, and adapted to be positioned within the blood vessel and to
extend to a position distal to the interventional procedure site.
The guide wire is further adapted to include an embolic protection
device mounted on the distal end thereof. The system also includes
a catheter, having a distal end, wherein the catheter has a lumen
therein extending in the catheter to the distal end thereof. The
guide wire and the embolic protection device are adapted to extend
in and through the lumen in the catheter. The catheter and the
guide wire are adapted to enable the embolic protection device to
be delivered and deployed distal to the interventional procedure
site. The catheter includes a manipulation-enabling element for
enabling the operator to manipulate the guide wire and the catheter
independently so as to enable removal thereof from the patient's
vasculature.
[0019] The system in such embodiment further includes a system for
enabling the at least one operator to control the recovery of the
embolic protection device, from the delivered and deployed position
thereof, for the exchange of the recovery system. The recovery
system includes the catheter, including the manipulation-enabling
element, for enabling the operator to independently manipulate the
guide wire and the catheter, so as to enable removal of the
catheter and the embolic protection device recovered thereby from
the patient's vasculature.
[0020] In another embodiment of the present invention, for example,
a delivery system is adapted to enable the delivery of an embolic
protection device to a position in a patient's vasculature distal
to an interventional procedure site, through the patient's
vasculature, for deployment of the embolic protection device. The
delivery system is adapted to maintain a clinically acceptable
profile and flexibility during the delivery and removal thereof
through the patient's vasculature.
[0021] The delivery system includes a guide wire, including a
distal end, adapted to be positioned within the blood vessel and to
extend to a position distal to the interventional procedure site,
and to include an embolic protection device mounted on the distal
end thereof. The delivery system further includes a delivery
sheath, including a distal end, and a lumen therein extending in
the delivery sheath to the distal end thereof, and wherein the
guide wire and the embolic protection device are adapted to extend
in and through the lumen. The delivery sheath and the guide wire
are adapted to enable the embolic protection device to be delivered
and deployed distal to the interventional procedure site. The
delivery sheath comprises dimensions and materials adapted to
provide a low profile, flexibility for enabling tracking thereof
through the patient's vasculature, and rigidity for enabling
pushing thereof through the patient's vasculature, so as to
maintain a clinically acceptable profile and flexibility during the
delivery and removal thereof through the patient's vasculature.
[0022] The system in such other embodiment also includes a recovery
system, adapted to enable the recovery of the embolic protection
device from the position in the patient's vasculature distal to the
interventional procedure site, for removal of the embolic
protection device. The recovery system is adapted to maintain a
clinically acceptable profile and flexibility during the delivery
and removal of the recovery system through the patient's
vasculature.
[0023] The recovery system includes an inner catheter, including a
distal end. The inner catheter has a lumen therein extending in the
inner catheter to the distal end thereof, and wherein the inner
catheter is adapted to extend over the guide wire, and the distal
end of the inner catheter is adapted to be positionable adjacent
the embolic protection device. The inner catheter comprises
dimensions and materials adapted to enable a smooth transition for
movement thereof along the guide wire, to inhibit kinking of the
guide wire during the delivery and removal of the inner catheter,
and to maintain a clinically acceptable profile and flexibility
during the delivery and removal thereof through the patient's
vasculature.
[0024] The recovery system further includes an outer catheter,
including a distal end, wherein the outer catheter has a lumen
therein extending in the outer catheter to the distal end thereof.
The outer catheter is adapted to extend over the inner catheter.
The outer catheter comprises dimensions and materials adapted to
enable a smooth transition for movement thereof along the inner
catheter, to enable the capturing of the embolic protection device,
and to inhibit trauma to the patient's vasculature, so as to
maintain a clinically acceptable profile and flexibility during the
delivery and removal thereof through the patient's vasculature.
[0025] The above objects and advantages of the present invention,
as well as others, are described in greater detail in the following
description, when taken in conjunction with the accompanying
drawings of illustrative embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 is a side elevational partly broken view of a first
form of a delivery version of a first embodiment of the present
invention, including a guide wire and a delivery catheter.
[0027] FIG. 2 is a top plan view of the first form of a delivery
version of the first embodiment shown in FIG. 1.
[0028] FIG. 3 is a similar view of the first form of the delivery
version of the first embodiment shown in FIG. 1, without a handle
at the proximal end of the delivery catheter.
[0029] FIG. 4 is an elevational fragmentary partly-sectional view
of the first delivery version of the first embodiment shown in FIG.
1, disposed within the internal carotid artery of a patent,
including the distal end of the guide wire and the delivery
catheter.
[0030] FIG. 5 is a similar view of the first form of the delivery
version of the first embodiment seen in FIG. 1, with a
different-shaped distal tip of the delivery catheter.
[0031] FIG. 6 is a similar view of the distal end of the first form
of the delivery version of the first embodiment illustrated in FIG.
4, including a cross-section of the tip of the delivery catheter, a
guide wire, and an embolic protection device.
[0032] FIG. 7 is a cross-sectional view taken along line 7-7 of
FIG. 6.
[0033] FIG. 8 is a side elevational partly-broken view of a second
delivery version of the first embodiment of the present
invention.
[0034] FIG. 9 is a similar view of the second delivery version of
the first embodiment shown in FIG. 8, including a guide wire, and
an embolic protection device at the distal end of the delivery
catheter.
[0035] FIG. 10 is a side elevational view of a first form of a
recovery version of a first embodiment of the present invention,
including an inner catheter
[0036] FIG. 11 is a cross-sectional view taken along the line 11-11
of FIG. 10.
[0037] FIG. 12 is a side elevational view of the first form of the
recovery version of the first embodiment of the present invention,
including an outer catheter.
[0038] FIG. 13 is a cross-sectional view taken along the line 12-12
of FIG. 11.
[0039] FIG. 14 is a side elevational partly-sectional assembly view
of the first form of the recovery version of the first embodiment
shown in FIGS. 10-13, depicting the outer catheter extending about
the inner catheter.
[0040] FIG. 15 is a side elevational partly-sectional partly-broken
view of the first form of the recovery version of the first
embodiment shown in FIG. 14, disposed within the internal carotid
artery of a patient, including the guide wire, the inner catheter,
the outer catheter, and an embolic protection device.
[0041] FIG. 16 is a side elevational partly-broken view of a second
form of the recovery version of the first embodiment of the present
invention, including a guide wire, an inner catheter, an outer
catheter, and an embolic protection device, disposed within the
internal carotid artery of a patient.
[0042] FIG. 17 is a side elevational view of a third form of a
recovery version of the first embodiment of the invention,
including a guide wire, and an embolic protection device proximate
the distal end of the recovery catheter.
[0043] FIG. 18 is a similar view of the third form of the recovery
version of the first embodiment seen in FIG. 16, with the embolic
protection device captured in the expanded tip of the recovery
catheter.
[0044] FIG. 19 is a side elevational view of a delivery version of
a second embodiment of the present invention, including a delivery
sheath.
[0045] FIG. 20 is a cross-sectional view taken along the line 20-20
of FIG. 19.
[0046] FIG. 21 is a side elevational view of a recovery version of
the second embodiment of the present invention, including an inner
catheter.
[0047] FIG. 22 is a cross-sectional view taken along the line 22-22
of FIG. 21.
[0048] FIG. 23 is a side elevational view of a recovery version of
the second embodiment of the present invention, including an outer
catheter.
[0049] FIG. 24 is a cross-sectional view taken along the line 24-24
of FIG. 23.
[0050] FIG. 25 is a side elevational partly-sectional assembly view
of the recovery version of the second embodiment shown in FIGS.
21-24, depicting the outer catheter extending about the inner
catheter.
[0051] FIG. 26 is a side elevational partly-sectional partly-broken
view of the recovery version of the second embodiment shown in FIG.
25, disposed within the internal carotid artery of a patient,
including the guide wire, the inner catheter, the outer catheter,
and an embolic protection device.
DETAILED DESCRIPTION OF THE INVENTION
[0052] The present invention is directed to an improved system and
method for enabling at least one operator to control the delivery
of an embolic protection device to a position in a patient's
vasculature distal to an interventional procedure site for
deployment of the embolic protection device. It is also adapted to
enable the operator to control the removal of the delivery system
from the patient's vasculature, in an efficient and effective
manner, for the exchange of the delivery and recovery system. It
further enables control of the position of a deployed embolic
protection device within the patient's vasculature by the operator
during an exchange of interventional devices. The system and method
are also adapted to enable the at least one operator to control the
recovery of the embolic protection device, from the delivered and
deployed position thereof, for the exchange of the recovery
system.
[0053] The present invention is further directed to an improved
system and method for enabling the delivery of an embolic
protection device to the position in a patient's vasculature distal
to the interventional procedure device for the deployment of the
embolic protection device, so as to maintain a clinically
acceptable profile and flexibility during the delivery and removal
thereof through the patient's vasculature. It is further adapted to
enable the recovery of the embolic protection device from the
position in the patient's vasculature distal to the interventional
procedure site, for removal of the embolic protection device, while
maintaining the clinically acceptable profile and flexibility
during the delivery and removal of the recovery system through the
patient's vasculature.
[0054] The embodiments of the improved system and method are
illustrated and described herein by way of example only and not by
way of limitation. While the present invention is described as
applied to the carotid arteries of the patient, those skilled in
the art will appreciate that it can also be used in other body
lumens as well, such as the coronary arteries, renal arteries,
saphenous veins and other peripheral arteries. Additionally, the
present invention can be utilized when performing any one of a
number of interventional procedures, such as stenting, balloon
angioplasty, laser angioplasty or atherectomy.
[0055] With respect to the drawings, wherein like reference
numerals denote like or corresponding parts throughout the drawing
figures, and particularly to FIGS. 1-26, in the embodiments of the
system and method in accordance with the invention, for example, a
system 10 is provided for enabling an interventional procedure to
be performed in a blood vessel 12 at an area of treatment 14. The
system 10 is adapted to be atraumatic. It includes a guide wire 16
adapted to enable the system 10 to be positioned distal to the area
of treatment 14. The system 10 is placed within the carotid artery
18 or other blood vessel of the patient, and is guided into
position by the guide wire 16. The guide wire 16 includes a coiled
tip 20 at a distal end 22 thereof. The carotid artery 18 has the
area of treatment 14 therein, which comprises the interventional
procedure site, wherein atherosclerotic plaque 24 has built up
against the inside wall 26 which decreases the diameter of the
carotid artery 18. As a result, blood flow is diminished through
this area.
[0056] The therapeutic interventional procedure comprises
implanting an expandable interventional instrument at the
interventional procedure site 14, to press the build-up of plaque
24 of the stenosis against the inside wall 26, to increase the
diameter of the occluded area 14 of the artery 18, and to help
restore sufficient flow of blood to the downstream vessels leading
to the brain. The expandable interventional instrument not only
helps increase the diameter of the occluded area, but helps prevent
restenosis in the area of treatment 14. The expandable
interventional instrument is adapted to be expanded and deployed at
the interventional procedure site 14.
[0057] The system 10 of the present invention is adapted to enable
the delivery of an embolic protection device 28 to a location
distal to the area of treatment 14, and to enable the removal of
the embolic protection device 28 from the delivered position
thereof. The embolic protection device 28 is adapted to filter the
blood in the blood vessel 12, so as to pass blood therethrough and
capture embolic material which may be released in the blood vessel
12 during the interventional procedure. The embolic protection
device 28 is adapted to be secured to the distal end 22 of the
guide wire 16, such that manipulation of the guide wire 16 enables
the embolic protection device 28 to be placed within the carotid
artery 18 or other blood vessel of the patient and guided into
position distal to the area of treatment 14.
[0058] Referring to FIGS. 1-18, in a first embodiment of a system
pursuant to the present invention, for example, the system 10 is
adapted to enable at least one operator to control of the delivery
of the embolic protection device 28 to the position in a patient's
blood vessel 12 distal to the area of treatment 14, for deployment
of the embolic protection device 28. The system 10 is further
adapted to enable the at least one operator to control the removal
of the delivery system 10, to enable the exchange of the delivery
system, and to enable the control of the position of a deployed
embolic protection device 28 within the patient's vasculature 12
during an exchange of interventional devices. The system 10 is
further adapted to enable the at least one operator to control the
removal of the embolic protection device 28 through the patient's
vasculature 12, from the delivered and deployed position thereof,
for the exchange of the recovery system.
[0059] As illustrated in FIGS. 1-9, in a delivery version of the
first embodiment of the invention, for example, the system 10
includes the guide wire 16, adapted to be positioned within the
blood vessel 12, and to extend to a position distal to the area of
treatment 14, and adapted to include the embolic protection device
28 mounted on the distal end 22 thereof. The system 10 also
includes a catheter 30, which includes a distal end 32. The
catheter 30 has a lumen 34 extending therein to the distal end 32
thereof. The guide wire 16 and the embolic protection device 28 are
adapted to extend in and through the lumen 34. The catheter 30 and
the guide wire 16 are adapted to enable the embolic protection
device 28 to be delivered and deployed distal to the interventional
procedure site 14.
[0060] The catheter 30 also includes a manipulation-enabling
element 36 for enabling the operator to manipulate the guide wire
16 and the catheter 30 independently, so as to enable removal of
the guide wire 16 and the catheter 30 through the patient's blood
vessel 12. The catheter 30 includes a distal end portion 38,
extending from the distal end 32 to a location spaced from the
distal end 32, a proximal end 40, and a distal-proximal portion 42,
extending from the distal end portion 38 to the proximal end 40.
The distal end portion 38 of the catheter 30 is relatively short,
for example about twenty centimeters long.
[0061] In a first form of the delivery version of the first
embodiment of the invention, as depicted in FIGS. 1-7, the
distal-proximal portion 42 of the catheter 30 includes a port 44
therein, proximate the distal end portion 42 of the catheter 30,
for enabling the guide wire 16 to exit therefrom and extend
therethrough and outside and along the relatively longer length of
the distal-proximal portion 42 of the catheter 30.
[0062] The manipulation-enabling element 36 extends along the
distal-proximal portion 42 of the catheter 30. The
manipulation-enabling element 40 is adapted to enable the guide
wire 16 to be peeled away from and extend outside the catheter 30
and along the distal-proximal portion 42 thereof. The
manipulation-enabling element 36 comprises a slit, extending along
the distal-proximal portion 42 of the catheter 30. The slit 36 is
adapted to enable the catheter 30 and the guide wire 16 to be
manipulated by the operator, so as to enable the guide wire 16 to
exit from and extend therethrough and outside and along the
distal-proximal portion 42 of the catheter 30. After the operator
manipulates the guide wire 16 such that the major portion thereof
exits the catheter 30 through the port 44, only a minor portion of
the guide wire 16 extends in the short length of the distal end
portion 38 of the catheter 30, enabling the operator to efficiently
manipulate the major portion of the guide wire independent of the
catheter 30. Further, with the major portion of the guide wire 16
adapted to exit the catheter 16 for independent manipulation
thereof by the operator, less overall length of guide wire 16 is
required to enable exchanges thereby.
[0063] The catheter 30 further includes a mandrel 48 extending
therein, as seen in FIG. 4, adapted to support the catheter 30, to
enable the catheter 30 to maintain a clinically acceptable profile
and flexibility during delivery and removal thereof through the
patient's vasculature 12. The mandrel 48 extends in a second lumen
50 in the catheter 30. The catheter 30 also includes a tip cover 52
at the distal end 34 thereof. The support mandrel 48 may include a
flattened distal end 54 thereof, adapted to enable the operator to
shape the distal end 52. The shapeable distal end 54 of the support
mandrel 48 may be connected to a super elastic distal segment,
which is connected to a stainless steel proximal segment. The
catheter 30 also includes a handle 56 at the proximal end 40
thereof.
[0064] The catheter 30 also includes a tip 58, at the distal end 32
thereof, adapted to be shapeable by the operator, to enable the
operator to direct the shapeable tip 58 for movement thereof in the
patient's vasculature. The shapeable tip 58 enables the operator to
track the system 10 over the guide wire 16 and through tortuous
anatomy, without having to rely on the guide wire 16 therefor. The
tip 58 is also radiopaque, for enabling the operator to locate the
tip 58.
[0065] In a second form of the delivery version of the first
embodiment of the system 10 pursuant to the present invention, for
delivery of an embolic protection device 28, as shown in FIGS. 8-9,
the manipulation-enabling element 36 comprises a projection 46, at
a location spaced from the proximal end 40 and the distal end 32 of
the catheter 30, adapted to communicate with the lumen 34, and to
enable a minor portion of the guide wire 16 to extend into the
lumen 34 therethrough, and a major portion of the guide wire 16 to
extend outside the catheter 30 therefrom. The projection 46 is
adapted to enable the catheter 30 and the guide wire 16 to be
manipulated independently by the operator. The distal end 32 of the
catheter 30 is enlarged for contact with the embolic protection
device 28.
[0066] As shown in FIGS. 10-18, in a recovery version of the first
embodiment pursuant to the present invention, for example, the
system 10 includes the guide wire 16, and the catheter 30.
[0067] In a first form of the recovery system of the first
embodiment in accordance with the invention, as seen in FIGS.
10-15, which corresponds to the first form of the delivery system
of the first embodiment as shown in FIGS. 1-7, the catheter 30
comprises an inner catheter, which includes the slit 36, the port
44, the mandrel 48, and the shapeable tip 58. The system 10 further
includes an outer catheter 60, adapted to extend about the inner
catheter 30, and to be extendable in the distal direction by the
operator so as to enclose the embolic protection device 28 for
enabling recovery thereof. The outer catheter 60 also includes the
slit 36, the port 44, the mandrel 48, and the shapeable tip 58. As
seen in FIG. 16, in a second form of the recovery version of the
first embodiment, which corresponds to the second form of the
delivery version of the first embodiment, as depicted in FIGS. 8-9,
the recovery system 10 includes the inner catheter 30, which
includes the projection 46, the outer catheter 60, and the mandrel
48. The recovery system 10, in a third form of the recovery version
of the first embodiment, as illustrated in FIGS. 17-18, includes
the catheter 30, which includes the mandrel 48, and the shapeable
tip 58, which is further adapted to be expandable to enable the
capture of the embolic protection device 28. The catheter 30
further includes a marker band 62, for enabling the operator to
track the location thereof.
[0068] Referring to FIGS. 19-26, in a second embodiment of a system
pursuant to the invention, for example, a system 64 is provided for
enabling the delivery and recovery of an embolic protection device
28 relative to a position in the patient's vasculature 12 distal to
an interventional procedure site 14, through the patient's
vasculature 12, for deployment of the embolic protection device 28.
The system 64 is adapted to maintain a clinically acceptable
profile and flexibility during the delivery and removal thereof
through the patient's vasculature 12. Elements of the system 64 are
comprised of polymer materials such as for example PeBax which is
comprised of a thermoplastic polyimide. Also, for the delivery of
the embolic protection device 28, the materials are such as to
provide substantial flexibility for enabling delivery thereof
through the patient's anatomy and for preventing the guide wire 16
from kinking, while providing sufficient rigidity for enabling
substantial pushing force to be exerted for delivery and deployment
thereof. Further, the dimensions of the elements of the system 64
are such as to provide a low profile for the delivery and recovery
thereof and of the embolic protection device 28, while inhibiting
vessel trauma.
[0069] In a delivery version of the second embodiment of the
invention, as depicted in FIGS. 19-20, the system 64 includes a
guide wire 16, including a distal end 22, adapted to be positioned
within the blood vessel 12 and to extend to the a position distal
to the interventional procedure site 14, and adapted to include the
embolic protection device 28 mounted on the distal end 22 thereof.
The delivery system 64 further includes a delivery sheath 66,
including a distal end 68, and has a lumen 70 therein extending in
the delivery sheath 66 to the distal end 68 thereof. The guide wire
16 and the embolic protection device 28 are adapted to extend in a
through the lumen 70. The delivery sheath 66 and the guide wire 16
are adapted to enable the embolic protection device 28 to be
delivered and deployed distal to the interventional procedure site
14. The delivery sheath 66 comprises dimensions and materials
adapted to provide a low profile, flexibility for enabling tracking
thereof through the patient's vasculature 14, and rigidity for
enabling pushing thereon through the patient's vasculature 14, to
maintain a clinically acceptable profile and flexibility during the
delivery and removal thereof through the patient's vasculature.
[0070] The delivery sheath 66 includes a tip 72 at the distal end
68 thereof, adapted to be necked for providing a profile close to
the guide wire 16, to inhibit kinking of the guide wire 16 during
the delivery and removal of the delivery sheath 66. The delivery
sheath 66 also includes a main shaft 74, adapted to provide the low
profile, flexibility, and rigidity. The main shaft 74 of the
delivery sheath 66 is comprised for example of PeBax, of about 72
Durometer. The tip 72 of the delivery sheath 66 is adapted to be
necked, for enabling the embolic protection device 28 to be loaded
therein for delivery thereof, and for enabling the release of the
embolic protection device 28 for deployment thereof. The tip 72 of
the delivery sheath 66 is radiopaque, and is comprised of soft
material to prevent vessel trauma. The delivery sheath 66 further
includes a proximal end 76, adapted to include a flushing valve
including a locking hub.
[0071] The delivery sheath 66, in an embodiment thereof, is about
140-145 centimeters in overall length, with a working length of
about 25-50 centimeters. The inside diameter of the main shaft 74
is about 0.020 inches, with an outside diameter of about 0.055
inches. The radiopaque necked tip 72 is a soft tip, comprised of a
compound including PeBax, of about 40 Durometer, and bismuth, with
a clinically acceptable profile and radiopacity, and is about 10-30
centimeters in length, with a maximum outside diameter of about
0.050 inches.
[0072] As seen in FIGS. 21-26, in a recovery version of the second
embodiment of a system pursuant to the invention, the system 64 is
also provided for enabling the recovery of the embolic protection
device 28 from the position in the patient's vasculature 12 distal
to the interventional procedure site 14, for removal of the embolic
protection device 28. The recovery system 64 is adapted to maintain
a clinically acceptable profile and flexibility during the delivery
and removal thereof through the patient's vasculature 12. The
recovery system 64 includes an inner catheter 78, adapted to be
positionable adjacent the embolic protection device 28.
[0073] The inner catheter 78 includes a distal end 80, a main shaft
82, and a lumen 84 extending in the inner catheter 78 through the
main shaft 82 to the distal end 80 thereof. The inner catheter 78
is adapted to extend over the guide wire 16, and the distal end 80
of the inner catheter 78 is adapted to be positionable adjacent the
embolic protection device 28. The inner catheter 78 comprises
dimensions adapted to enable a smooth transition for movement
thereof along the guide wire 16, to inhibit kinking of the guide
wire 16 during the delivery and removal of the inner catheter 78,
and to maintain a clinically acceptable profile and flexibility
during the delivery and removal thereof through the patient's
vasculature 12. The inner catheter 78 further includes a tip 86 at
the distal end 80 thereof. The main shaft 82 of the inner catheter
78 is comprised for example of PeBax, of about 72 Durometer. The
tip 86 of the inner catheter 78 is radiopaque. The inner catheter
78 further includes a proximal end 88, adapted to include a
flushing valve including a locking hub.
[0074] The inner catheter 78, in an embodiment thereof, is about
145-151 centimeters in overall length, with a working length of
about 25-50 centimeters. The inside diameter of the main shaft 82
is about 0.020 inches, with an outer diameter of about 0.055
inches. The radiopaque tip 86 is comprised of a compound including
PeBax, of about 40 Durometer, and bismuth.
[0075] The system 64, in the recovery version of the second
embodiment thereof, further includes an outer catheter 90,
including a distal end 92, and a main shaft 94. The outer catheter
90 has a lumen 96 therein extending through the main shaft 94 in
the outer catheter 90 to the distal end 92 thereof. The outer
catheter 90 is adapted to extend over the inner catheter 78. The
outer catheter 90 comprises dimensions and materials adapted to
enable a smooth transition for movement thereof along the inner
catheter 78, to enable the capturing of the embolic protection
device 28, and to inhibit trauma to the patient's vasculature, to
maintain a clinically acceptable profile and flexibility during the
delivery and removal thereof through the patient's vasculature 12.
The outer catheter 90 further includes a tip 98 at the distal end
92 thereof. The main shaft 94 of the outer catheter 90 is comprised
for example of high density PE. The tip 98 of the outer catheter 90
is radiopaque. The outer catheter 90 further includes a proximal
end 100, adapted to include a flushing valve including a locking
hub.
[0076] The outer catheter 90, in an embodiment thereof, is about
140-145 centimeters in overall length, with a working length of
25-50 centimeters. The outer catheter 90 is shorter than the inner
catheter 78. The inside diameter of the main shaft 94 is about
0.065 inches, with an outer diameter of about 0.075 inches. The
radiopaque tip 98 is a soft tip, comprised of a compound including
PeBax, of about 40 Durometer, and bismuth.
[0077] The outer catheter 90 and the inner catheter 78 of the
system 64 interact such that the inner catheter 78 is adapted to
enable smooth movement thereof over the guide wire 16, to enable
smooth transition from the guide wire 16 to the outer catheter 90,
and to resist the development of kinks in the system 64.
[0078] Referring to FIGS. 1-18, in a method for the use of the
first embodiment of the invention, for enabling the at least one
operator to deliver and remove the embolic protection device 28
relative to the position thereof distal to the area of treatment 14
in the patient's blood vessel 12, for example, the system 10 is
positioned in and removed from the patient's vasculature 12 by the
operator utilizing any one of a number of different methods.
[0079] In a method for enabling the operator to delivery the
embolic protection device 28 to the position in the patient's
vasculature 12 distal to the interventional procedure site 14 for
deployment of the embolic protection device 28, as illustrated in
FIGS. 1-11, the delivery system 10 is adapted to maintain a
clinically acceptable profile and flexibility during the delivery
and removal thereof through the patient's vasculature. The guide
wire 16 is inserted into the patient's vasculature 12, with the
embolic protection device 28 secured thereto and the catheter 30
detachably secured to the embolic protection device 28. The guide
wire 16 is then manipulated by the operator to the area of
treatment 14, to cross the stenosis in the blood vessel 12, so as
to position the embolic protection device 28 for capturing embolic
material which may be released in the blood vessel 12 during the
interventional procedure. After the embolic protection device 28 is
in place, it is deployed by the operator at the position distal to
the stenosis in the blood vessel 12. The operator then detaches the
catheter 30 from the embolic protection device 28, and manipulates
the catheter 30, holding the guide wire 16, so as to remove the
catheter 30 from the patient's vasculature 12.
[0080] In the first form of the delivery version of the first
embodiment as seen in FIGS. 1-7, the operator manipulates the
catheter 30 and the guide wire 16 independently for removal of the
catheter 30, upon peeling away the guide wire 16 from the catheter
30 through the slit 36 extending along the distal-proximal portion
42 of the catheter 30. The operator, in the second form of the
delivery version of the first embodiment as shown in FIGS. 8-9,
manipulates the catheter 30 and the guide wire 16 independently for
removal of the catheter 30, upon gripping the catheter 30 and the
portion of the guide wire 16 extending from the projection 46 in
the catheter 30 at the location spaced from the proximal end 40 and
the distal end 32 of the catheter 30.
[0081] The embolic protection device 28 is recovered by the
operator, in the recovery versions of the first embodiment of the
invention as illustrated in FIGS. 10-18, for example, after the
interventional procedure is performed, by extending a catheter to
the embolic protection device 28, capturing the embolic protection
device 28, and removing the catheter and the embolic protection
device 28 from the patient's vasculature 14.
[0082] In a first form of the recovery system 64 as seen in FIGS.
10-15, the operator manipulates the guide wire 16, which extends
through the port 44 and through the slit 36, to enable removal
thereof. The operator, in the second form of the recovery system 64
shown in FIG. 16, manipulates the portion of the guide wire 16
extending from the projection 46 in the inner catheter 30, along
with the inner catheter 30, with the outer catheter 60 extending
about the distal end 32 of the inner catheter 30, and with the
embolic protection device 28 enclosed in the outer catheter 60. As
depicted in FIGS. 17-18, the operator expands the expandable tip 58
of the catheter 30 to capture the embolic protection system 28, and
recovers the catheter 30 and the embolic protection system 28.
[0083] Referring to FIGS. 19-26 in a method for the use of the
second embodiment of the invention, for enabling the delivery and
removal of the embolic protection device 28 in relation to the
location thereof distal to the occluded area 14 in the patient's
vasculature, for example, the system 64 may be positioned in and
removed from the patient's vasculature 12 by utilizing any one of a
number of different methods.
[0084] In a method for enabling the delivery of the embolic
protection device 28 to the position in the patient's vasculature
12 distal to the interventional procedure site 14 for deployment of
the embolic protection device 28, as seen in FIGS. 19-20, the
delivery system 64 is adapted to maintain a clinically acceptable
profile and flexibility during the delivery and removal thereof
through the patient's vasculature. The guide wire 16 is inserted
into the patient's vasculature 12, with the embolic protection
device 28 positioned relative to the tip 72 of the delivery sheath
66. The delivery sheath 66 and the embolic protection device 28 are
delivered through the patient's vasculature 12 to the area of
treatment 14, to cross the stenosis in the blood vessel 12, so as
to position the embolic protection device 28 for capturing embolic
material which may be released in the blood vessel 12 during the
interventional procedure. The delivery sheath 66 is adapted to
maintain a clinically acceptable profile and flexibility during the
delivery thereof.
[0085] After the embolic protection device 28 is in place, it is
deployed at the position distal to the stenosis in the blood vessel
12. The delivery sheath 66 is then withdrawn from the embolic
protection device 28, and removed through the patient's vasculature
12, while maintaining the clinically acceptable profile and
flexibility during the removal thereof.
[0086] The embolic protection device 28 is recovered after the
interventional procedure is performed, in the recovery version of
the second embodiment of the invention as shown in FIGS. 21-26, by
inserting the inner catheter 78 into the patient's vasculature 12,
through the patient's anatomy, to a position adjacent the embolic
protection device 28. During the inserting thereof, the inner
catheter 78 is adapted to maintain a clinically acceptable profile
and flexibility. The outer catheter 90 is then inserted into the
patient's vasculature 12 so as to extend about the inner catheter
78, to a position extending about and capturing the embolic
protection device 28 therein. The outer catheter 90 is then removed
through the patient's vasculature 12, with the inner catheter 76
and the embolic protection device 28 enclosed therein. A clinically
acceptable profile and flexibility is maintained by the outer
catheter 90, and the inner catheter 78, during removal thereof from
the patient's vasculature 12.
[0087] In accordance with the present invention, the particular
embodiments set forth above of the system 10 and the system 64 are
capable of being positioned in the blood vessel 12. However, other
forms of the system 10 and the system 64 may be utilized with the
present invention without departing from the spirit and scope of
the invention. For example, the system 10 and the system 64 may be
comprised of other forms of material. Additionally, while the
system 10 and the system 64 are shown as in various shapes in the
embodiments herein, they can be formed in any one of a number of
different shapes depending upon the construction desired.
[0088] Further, the various components may be joined by suitable
adhesives such as acrylonitrile based adhesives or cyanoacrylate
based adhesives. Heat shrinking or heat bonding may be employed
where appropriate. Plastic-to-plastic or plastic-to-metal joints
may be effected by a suitable acrylonitrile or cyanoacrylate
adhesive. Variations may be made in the composition of the
materials to vary properties as needed. Based on the present
disclosure, other adhesives and applications may be made known to a
person skilled in the art.
[0089] In view of the above, the system and method of the first
embodiment of the present invention are adapted to substantially
enhance the effectiveness of performing interventional procedures,
by enabling at least one operator to deliver an embolic protection
device to a position for deployment thereof distal to an
interventional procedure site in a patient's vasculature, and to
remove the delivery system from the patient's vasculature. The
article enables the operator to recover the embolic protection
device and to remove the system and the embolic protection device
from the patient's vasculature. The system and method of the second
embodiment of the present invention substantially enhance the
effectiveness of performing interventional procedures, by enabling
the delivery of an embolic protection device to the position in the
patient's vasculature distal to the interventional procedure site,
for deployment thereof. The system also enables the delivery and
removal of the delivery system from the patient's vasculature,
while maintaining a clinically acceptable profile and flexibility.
It also enables the recovery of the embolic protection device and
the removal of the system and the embolic protection device, while
maintaining the clinically acceptable profile and flexibility
during the recovery and removal thereof through the patient's
vasculature.
[0090] While the present invention has been described in connection
with the specific embodiments identified herein, it will be
apparent to those skilled in the art that many alternatives,
modifications and variations are possible in light of the above
description. Accordingly, the invention is intended to embrace all
such alternatives, modifications and variations as may fall within
the spirit and scope of the invention disclosed herein.
* * * * *