U.S. patent application number 13/048856 was filed with the patent office on 2011-09-15 for methods and devices for protecting a passageway in a body when advancing devices through the passageway.
Invention is credited to Sunmi Chew, Mark E. Deem, Martin S. Dieck, Hanson S. Gifford, Ivan Sepetka, Allan R. Will.
Application Number | 20110224773 13/048856 |
Document ID | / |
Family ID | 23649445 |
Filed Date | 2011-09-15 |
United States Patent
Application |
20110224773 |
Kind Code |
A1 |
Gifford; Hanson S. ; et
al. |
September 15, 2011 |
METHODS AND DEVICES FOR PROTECTING A PASSAGEWAY IN A BODY WHEN
ADVANCING DEVICES THROUGH THE PASSAGEWAY
Abstract
A liner is advanced through a narrowed region in a vessel such
as the internal carotid artery. The liner is advanced through the
narrowed region in a collapsed position. A stent is then advanced
through the liner and expanded to open the narrowed region. The
liner may also have an anchor which expands an end of the liner
before the stent is introduced.
Inventors: |
Gifford; Hanson S.;
(Woodside, CA) ; Sepetka; Ivan; (Los Altos,
CA) ; Deem; Mark E.; (San Francisco, CA) ;
Will; Allan R.; (Atherton, CA) ; Dieck; Martin
S.; (Cupertino, CA) ; Chew; Sunmi; (San Jose,
CA) |
Family ID: |
23649445 |
Appl. No.: |
13/048856 |
Filed: |
March 15, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10956433 |
Oct 1, 2004 |
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13048856 |
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10090456 |
Mar 4, 2002 |
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10956433 |
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09416309 |
Oct 12, 1999 |
6383171 |
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10090456 |
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Current U.S.
Class: |
623/1.11 ;
623/1.15 |
Current CPC
Class: |
A61F 2/0095 20130101;
A61F 2002/072 20130101; A61F 2/958 20130101; A61F 2/966 20130101;
A61F 2/97 20130101; A61F 2/90 20130101; A61F 2230/0067 20130101;
A61F 2002/075 20130101; A61F 2230/0069 20130101; A61F 2230/0006
20130101; A61F 2/07 20130101; A61F 2250/0098 20130101; A61F
2002/018 20130101; A61F 2230/0078 20130101; A61F 2/013
20130101 |
Class at
Publication: |
623/1.11 ;
623/1.15 |
International
Class: |
A61F 2/82 20060101
A61F002/82 |
Claims
1-41. (canceled)
42. A method of advancing a device through a passageway in a body,
comprising the steps of: providing a liner movable from a collapsed
condition to an expanded condition; advancing the liner to region
in a passageway in a body with the liner in the collapsed position;
passing at least a portion of the liner into the region in the
collapsed position; and introducing a device into the liner so that
the device is also positioned in the region of the passageway, the
liner preventing the device from contacting the region of the
passageway.
43. The method of claim 42, wherein: the introducing step is
carried out with the device is selected from the group consisting
of a stent, filter, angioplasty balloon, drug delivery device or
catheter, laser catheter, and ultrasound catheter.
44. The method of claim 42, further comprising the step of:
expanding the stent to trap the liner between the stent and the
vessel wall.
45. The method of claim 42, wherein: the providing step is carried
out with the liner having an outer diameter of no more than 0.065
inch in the collapsed position.
46. The method of claim 45, wherein: the providing step is carried
out with the liner having an outer diameter of no more than 0.040
inch in the collapsed position.
47. The method of claim 42, wherein: the providing step is carried
out with the liner being collapsed to a radial thickness of no more
than 0.025 inch.
48. The method of claim 42, wherein: the providing step is carried
out with the liner being collapsed to a radial thickness of no more
than 0.020 inch.
49. The method of claim 42, wherein: the providing step is carried
out with the liner being mounted onto a tube of material having a
lumen; and the advancing step is carried out with the liner being
advanced over a guidewire passing through the lumen in the
tube.
50. The method of claim 42, wherein: the providing step is carried
out with the liner having a length to width ratio of at least 20 to
1.
51. The method of claim 42, wherein: the providing step is carried
out with the liner having a length to width ratio of at least 40 to
1.
52. The method of claim 42, wherein: the providing step is carried
out with the liner having a length to width ratio of at least 60 to
1.
53. A device for protecting a passageway in a body when passing
other devices through the passageway, comprising: a liner movable
from a collapsed position to an expanded position, the liner having
a diameter of no more than 0.018 inch in the collapsed position,
the liner having an outer diameter of no more than 0.040 inch when
in the collapsed position; and an expandable anchor attached to the
liner, the anchor being movable from an expanded shape to a
collapsed shape, the anchor being configured to hold the liner at a
position in a passageway in a body.
54. The device of claim 53, wherein: the liner has an outer
diameter of no more than 0.026 inch.
55. The device of claim 53, wherein: the liner has a length, the
length to diameter ratio for the liner being at least 20 to 1.
56. The device of claim 55, wherein: the length to diameter ratio
is at least 50 to 1.
57. The device of claim 55, wherein: the length to diameter ratio
is at least 80 to 1.
58. The device of claim 55, wherein: the anchor is mounted inside a
delivery catheter which holds the anchor in the collapsed position,
the anchor being naturally biased toward the expanded position.
59. The device of claim 53, further comprising: a retractable
sheath disposed over the liner when the liner is in the collapsed
position.
60. The device of claim 53, further comprising: an inner tube which
has a throughhole to receive a guidewire, the liner being mounted
over the inner tube so that the inner tube prevents the liner from
contacting the guidewire.
61. The device of claim 53, wherein: the liner has a thickness in a
radial direction of no more than 0.012 inch.
62. The device of claim 53, wherein: the liner has a first end and
a second end, the anchor being attached to the first end and the
liner being free at the second end when in the expanded
position.
63-67. (canceled)
Description
BACKGROUND OF THE INVENTION
[0001] The present invention is directed to methods and devices for
protecting a passageway in a body when advancing devices through
the passageway. A specific application of the present invention is
for treatment of blood vessels although the invention may be used
in any part of the body. For example, the present invention is used
to protect blood vessels during intravascular procedures for
treating aneurysms, arteriovenous malformations, and
atherosclerotic disease of vessels. A particular application of the
present invention is for atherosclerotic disease of the carotid
arteries or saphenous vein grafts. Carotid artery atherosclerotic
occlusive disease contributes to hundreds of thousands of strokes
annually in the United States. Atherosclerotic disease of the
internal carotid artery is particularly problematic since plaque
dislodged from the internal carotid artery leads directly to the
cerebral vasculature.
[0002] A conventional method of treating carotid artery occlusive
disease is by surgical removal of the plaque (carotid
endarterectomy). The carotid artery is opened surgically, the
plaque is removed and the carotid artery is then closed. Carotid
endarterectomies have demonstrated significant clinical benefit
over conservative treatment with medication by reducing strokes
over the next five years. Although carotid endarteretomy reduces
strokes over a period of time after the procedure, the procedure
still has a 6% risk of death or stroke.
[0003] Another method of treating carotid artery disease is to use
interventional devices such as stents. A problem with treating
carotid artery occlusive disease with stents is that the user is
wary of dislodging plaque when advancing the stent through the
carotid artery. Any plaque which breaks free during introduction of
the stent travels directly to the patient's brain and can cause a
stroke or death.
[0004] Yet another method of treating carotid artery occlusive
disease is to introduce a filter through the carotid artery to trap
emboli released during subsequent deployment of a stent or
angioplasty balloon. This method suffers the same drawback in that
advancement of the filter itself may dislodge plaque. Moreover,
exchange of various therapeutic catheters over the filter element
result in undesirable movement of the filter with attendant risk of
losing filtered emboli or damaging the vessel wall with the
filter.
[0005] The present invention is directed to improved methods of
protecting a body passageway when advancing devices through the
body passageway. The present invention is also directed to improved
methods of treating atherosclerotic vessels and, in particular,
occlusive disease of the internal carotid artery.
SUMMARY OF THE INVENTION
[0006] In accordance with the objects of the invention, a liner is
provided to protect a body passageway during introduction of other
devices into the passageway. In a specific application, the methods
and devices of the present invention are used to protect blood
vessels, such as the internal carotid artery, during intravascular
procedures. It is understood that use of the present invention for
protection of blood vessels is discussed as an example of how the
present invention may he used, however, the invention may he used
in any other part of the body without departing from the scope of
the invention. The liner is collapsed for introduction into the
patient and advanced to a narrowed region of a blood vessel. The
liner is passed through a region of the blood vessel in the
collapsed condition and an intravascular device, such as a stent or
filter, is then introduced into the liner. The liner may be used to
protect vessels from any type of problem including atherosclerotic
disease, perforation, aneurysm or AVM.
[0007] The liner protects the vessel as the intravascular device is
passed through the region to prevent the device from dislodging
plaque. When the device is a stent, the stent is preferably
expanded within the liner to trap the liner between the stent and
the vessel. The liner may be expanded by the stent or may be
partially or fully expanded before introduction of the stem. The
devices and methods of the present invention are particularly
useful for treating occlusive disease of the internal carotid
artery. The liner may be any suitable material and suitable
materials include expanded PTFE, woven dacron, nylon, low durometer
silicone, or thin-walled polyethylene.
[0008] The liner is preferably mounted to a delivery catheter and
is advanced over a guidewire. The liner may have an anchor at a
proximal end which is used to open the proximal end of the liner.
The anchor may be self-expanding or balloon expandable. Once the
proximal end of the liner is opened, the liner can be designed so
that blood pressure opens the liner. Alternatively, the liner may
open automatically or may be opened with a separate device, the
delivery catheter or the stent itself. When treating occlusive
disease of the internal carotid artery, the anchor may be
positioned completely in the internal carotid artery or may extend
from the common carotid artery across the bifurcation of the
internal and external carotid arteries and into the internal common
carotid. The anchor preferably has an open structure which permits
blood flow into the external carotid artery.
[0009] The liner may be an elastic liner or may be folded into a
collapsed position. The liner may be collapsed in any suitable
manner and preferably has a number of folded sections which are
wrapped around one another. The folded sections are preferably
adhered to one another to hold the liner in the collapsed position.
The folded sections may be adhered together by application of heat
or with an adhesive or coating. The distal end of the liner may be
coated to form a curved surface which covers the ends of the folded
sections. Alternatively, the ends of the liner may be scalloped or
contoured so that when folded the edge tapers down more
cleanly.
[0010] The liner may also be designed to evert when expanding. The
everting liner reduces sliding between the liner and vessel so that
plaque is not dislodged when introducing the liner. An end of the
everting liner may be releasably attached to the delivery
catheter.
[0011] The proximal end of the liner may also be opened with an
expandable device, such as a balloon, on the delivery catheter
rather than with an anchor attached to the liner. Once the proximal
end is open, the stent or other device is advanced through the
liner.
[0012] In yet another aspect of the invention, the catheter holds
the proximal end partially open. The stent or other device is then
advanced through the open proximal end. The liner can be released
when using a stent or may be removed after use.
[0013] These and other features and advantages of the invention
will become evident from the following description of the preferred
embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 shows a system for advancing devices through a
narrowed region of a blood vessel such as the internal carotid
artery.
[0015] FIG. 2 shows a liner advanced through the narrowed region in
a collapsed position.
[0016] FIG. 3 shows the liner detached from the delivery catheter
and expanded.
[0017] FIG. 4 shows only the proximal end of the liner expanded
with an anchor.
[0018] FIG. 5 shows the liner having openings or perforations.
[0019] FIG. 6A shows the liner having a woven or braided
configuration.
[0020] FIG. 6B shows the liner having a radiopaque maker and a
scalloped distal end.
[0021] FIG. 7 shows the liner folded into six folded sections.
[0022] FIG. 8 shows the folded sections wrapped around one
another.
[0023] FIG. 9 shows an end view of the liner of FIG. 7.
[0024] FIG. 10 shows an end view of the liner of FIG. 8 with the
liner wrapped around a guidewire.
[0025] FIG. 11 shows the liner having four folded sections.
[0026] FIG. 12 shows the liner of FIG. 11 with the folds wrapped
around one another.
[0027] FIG. 13 shows a coating over a distal end of the liner.
[0028] FIG. 14 shows the coating extending over the length of the
liner.
[0029] FIG. 15 is a cross-sectional view of the liner and coating
with four, folded sections.
[0030] FIG. 16 is a cross-sectional view of the liner and coating
with six folded sections.
[0031] FIG. 17 shows a sheath covering the liner in the collapsed
condition.
[0032] FIG. 18 shows a filament tearing a distal end of the
sheath.
[0033] FIG. 19 shows the liner attached to the anchor.
[0034] FIG. 20 shows the liner attached to a tapered anchor.
[0035] FIG. 21 shows an anchor contained entirely within the
internal carotid artery.
[0036] FIG. 22 shows the balloon expanding the anchor and blocking
blood flow into the internal carotid artery.
[0037] FIG. 23 shows the liner and anchor of FIG. 22 deployed.
[0038] FIG. 24 shows a balloon-expandable stent introduced into the
liner.
[0039] FIG. 25 shows the stent expanded.
[0040] FIG. 26A shows an elongate element which opens the distal
end of the liner.
[0041] FIG. 26B shows the elongate element contained within a tube
during delivery of the liner.
[0042] FIG. 26C shows the elongate element of FIG. 26B advanced
into a pocket of the liner to open the proximal end of the
liner.
[0043] FIG. 26D shows the stent introduced into the liner of FIG.
26C.
[0044] FIG. 27 shows the delivery catheter for the anchor used to
deliver a stent into the liner.
[0045] FIG. 28 shows the distal end of the stent of FIG. 27
expanded to trap plaque behind the liner.
[0046] FIG. 29 shows the delivery catheter for the anchor used to
deliver a distal anchor.
[0047] FIG. 30 show the delivery catheter in position for
delivering the distal anchor.
[0048] FIG. 31 shows the distal anchor deployed so that the
proximal and distal ends of the liner are expanded.
[0049] FIG. 32 shows another stent delivered between the proximal
and distal anchors.
[0050] FIG. 33 shows the stent of FIG. 32 expanded.
[0051] FIG. 34 shows a delivery catheter having an expandable
section for opening the proximal end of the liner.
[0052] FIG. 35 shows the proximal end of the liner opened with the
expandable section.
[0053] FIG. 36 shows the stent advanced through the liner.
[0054] FIG. 37 shows the stent partially expanded.
[0055] FIG. 38 shows the stent expanded into contact with the
vessel wall and the liner released from the delivery catheter.
[0056] FIG. 39 shows the stent fully expanded.
[0057] FIG. 40 show a filter passed through the liner.
[0058] FIG. 41 shows the liner everting when deployed.
[0059] FIG. 42 shows the liner partially everted.
[0060] FIG. 43 shows the liner almost completely evened and the
distal end released.
[0061] FIG. 44 shows the liner released from the delivery
catheter.
[0062] FIG. 45 shows another delivery catheter which holds the
proximal end of the liner open.
[0063] FIG. 46 shows the stent advanced through the liner of FIG.
45.
[0064] FIG. 47 shows another delivery catheter for the liner.
[0065] FIG. 48 shows still another delivery catheter for the
liner.
[0066] FIG. 49 shows yet another delivery catheter for the
liner.
[0067] FIG. 50 shows a distal end of the liner trapped in a
fold.
[0068] FIG. 51 shows a kit having devices and instructions for use
in accordance with the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0069] A system 2 for protecting vessels during intravascular
procedures is shown in FIGS. 1-4. Although the present invention is
described in relation to treatment of atherosclerotic disease of
the internal carotid artery and the particular problems encountered
when working in the carotid arteries, the liner may be used in
other vessels such as saphenous vein grafts of coronary bypass
procedures, iliac and coronary arteries. A guide catheter 4 is
introduced through the femoral artery and advanced to the common
carotid artery in the conventional manner. The guide catheter 4 has
a hemostasis valve 6 which receives a liner delivery catheter 8.
The guide catheter 4 may be omitted without departing from the
scope of the invention.
[0070] A liner 10 is used to protect the body passageway when
passing other devices through the body passageway. For example, the
liner 10 may be used to protect the carotid artery to prevent
plaque from being dislodged when passing other devices through the
carotid artery. A proximal end 11 of the liner 10 may be attached
to an anchor 12 which expands and opens the liner 10 and holds the
liner 10 against the vessel wall to reduce or eliminate flow around
the liner. The liner is preferably non-metallic and is relatively
flexible to conform to the body passageway. The anchor 12, as will
be discussed below, is mounted to one end of the liner 10 while the
other end of the liner 10 is preferably free.
[0071] The liner 10 is advanced through the vessel in the collapsed
condition of FIG. 2 so that the liner 10 can be advanced through
small or highly stenosed vessels. After the liner 10 is in
position, other devices, such as a stent 26 (FIG. 25) or filter
(FIG. 40), may be passed through the liner 10 so that the liner 10
prevents contact between the device and the vessel wall. The liner
10 may also be used to protect the vessel when advancing other
devices such as angioplasty balloons, drug delivery catheters,
laser catheters or ultrasound catheters. FIG. 3 shows both ends of
the liner 10 opened to trap plaque behind the liner 10 so that
loose plaque cannot flow downstream. The liner 10 is preferably
delivered over a conventional guidewire 15 which has a 0.010-0.018
inch diameter but may be of any other suitable size depending upon
the vascular site.
[0072] The liner 10 is preferably made of expanded PTFE having a
thickness of 0.006 to 0.002 inch, more preferably 0.001 to 0.002
inch and most preferably about 0.001 +/-0.0005 inch although any
other suitable material may be used. For example, the liner 10 may
have a woven construction such as silk or polyester as shown in
FIG. 5. The liner 10 may also have small openings 25 or
perforations which act similar to a filter in that they permit
blood to flow through but prevent large emboli from escaping (FIG.
6A). The openings 25 also may promote tissue growth. Referring to
FIG. 6B, the liner 10 may also have a scalloped distal end 7 to
form a smoother transition at the distal end when collapsed. The
liner 10 may also have a radiopaque marker 9, such as a 0.002 inch
by 0.008 inch platinum ribbon, embedded, sewn, or folded into the
liner 10. The liner 10 may have the markers 9 extending
longitudinally (FIG. 6B) or circumferentially. When the markers 9
extend longitudinally, three markers 9 are preferably provided 120
degrees apart.
[0073] The liner 10 may also be elastic so that the liner 10
remains substantially cylindrical and without folds in the
collapsed and expanded positions. When using an elastic liner 10,
the liner 10 is preferably a tube of low durometer silicone, latex
or natural rubber, thermoplastic elastomers such as Kraton or
hydrogenated thermoplastic isoprenes having a thickness of 0.001 to
0.0005 inch. Alternatively, the liner 10 could he made of an
inelastic but plastically deformable material. Initially the liner
10 would he sized to allow easy passage of the devices such as the
balloons, stents and filters described herein. The liner 10 is then
plastically deformed by the devices which pass therethrough. For
example, a pre-dilatation balloon may be introduced to dilate the
liner 10. The stent 27 can then be advanced into the dilated liner
10 and expanded to open the narrowed vessel. Expansion of the stent
continues plastic deformation of the liner 10 to a final size. Any
of the liners 10 described herein may be substituted for any of the
other liners 10 without departing from the scope of the
invention.
[0074] FIGS. 7-12 show a preferred method of collapsing the liner
10. The liner 10 is folded longitudinally along creases 13 to
create at least 2 and preferably 4-6 folded sections 14. Four
folded sections 14 are shown in FIGS. 11 and six folded sections 14
are shown in FIGS. 7 and 9. The folds 14 are then wrapped as shown
in FIGS. 8, 10 and 12. The liner 10 may, of course, be wrapped in
any other manner. For example, the liner 10 may be spiral wrapped
or randomly compressed and set with high pressure and/or heat. The
folded sections 14 may be adhered to one another by application of
heat which holds the folded sections 14 together without melting
and fusing the sections 14 together. Another method of holding the
liner 10 in the collapsed position is to apply an adhesive 16 such
as medical grade glue, cyanoacrylates, epoxies, ultraviolet
activated adhesives, low molecular weight polyvinyl alcohol
polymer, gelatin and sucrose. The liner 10 may also be partially or
completely covered with a coating 20 which dissolves in blood such
as sugar (FIGS. 13-16). In particular, the distal end 19 of the
liner 10 may he covered with the coating 20 to form a smooth,
atraumatic end as shown in FIG. 13. The coating 20 may extend along
the length of the liner 10 as shown in FIG. 14 or may be only at
the distal end or intermittent as shown in FIG. 13.
[0075] The liner 10 may also be covered by a removable sheath 21 as
shown in FIGS. 17 and 18. The sheath may be removed in any manner
such as tearing along perforations or with a chemical, thermal or
electrolytically severable bond. A filament 23 may also be used to
tear the sheath 21 as shown in FIGS. 17 and 18. The filament 23 may
have both ends extending through the catheter rather than having
one end extend out of the catheter. The filament 23 is shown
separated from the sheath 21 for clarity but would either pass
inside the sheath 21 or would be partially embedded in the sheath
21. The sheath 21 can also be a simple retractable sheath 21 as is
known in the art.
[0076] Referring again to FIGS. 10 and 12, the liner 10 is
collapsed onto the guidewire 15 so that the liner 10 has an outer
diameter .A-inverted. of no more than 0.065 inch, more preferably
no more than 0.040 inch, and most preferably no more than 0.026
inch. Stated another way, the thickness .E-backward. of the liner
10 is preferably no more than 0.015 inch, more preferably no more
than 0.012 inch, and most preferably no more than 0.008 inch when
measured in a radial direction. For a guidewire 15 having a 0.014
inch diameter, the liner 10 is preferably collapsed so that the
outer diameter .A-inverted. is 0.020 to 0.032 inch, preferably
about 0.026 inch, and the thickness .E-backward. of the liner 10 is
0.004 to 0.008 inch, preferably about 0.006 inch. For a guidewire
15 having a 0.018 inch diameter, the liner 10 is preferably
collapsed so that the outer diameter .A-inverted. is still about
0.020 to 0.032 inch, preferably about 0.026 inch. and the thickness
.E-backward. of the liner 10 is 0.003 to 0.006 inch, preferably
about 0.004 inch. The liner 10 also has a high ratio of collapsed
cross-sectional area to expanded circumference in the range of 1:10
to 1:30 and preferably at least 1:20.
[0077] The relatively small size of the liner 10 advantageously
permits the liner 10 to be introduced through small and heavily
stenosed vessels. The carotid artery is often occluded 95 to 98%
and may have diameters as small as 0.020 inch or even 0.010 inch
before surgical or interventional procedures are performed.
Conventional stents used in the internal carotid artery have a
collapsed diameter of about 0.065 to 0.092 inch and, thus, must
often displace the plaque to pass through the vessel. It is
believed that some strokes which occur when using stents in the
carotid artery are caused by plaque which is dislodged when the
stent is advanced through and expanded within highly stenosed
regions. The liner 10 of the present invention protects the vessel
as the stent or other device is passed through the vessel. The
liner 10 preferably has a length (of at least 2 cm and preferably
2-10 cm (FIG. 2). The liner 10 and anchor 12 have a diameter of
4-10 mm in the expanded condition with the specific size selected
depending upon the size of the vessel being treated. The relative
dimensions shown in the drawing have been exaggerated to illustrate
the features of the invention. In fact, the liner 10 has a length
to width ratio ((to .A-inverted.) in the collapsed position of at
least 20 to 1, 50 to 1, 80 to 1, and even up to 200 to 1 depending
upon the particular application. The liner 10 preferably increases
in outer diameter at least 5, more preferably at least 6 and most
preferably at least 8 times when moving from the collapsed to
expanded positions.
[0078] Referring again to FIGS. 3 and 4, the anchor 12 may be
attached to the proximal end 11 of the liner 10 to expand the end
11 of the liner 10, hold the liner 10 in position and reduce flow
around the liner 10. The anchor 12 may be any suitable device
including a commercially available nitinol or stainless steel stent
such as the MULTILINK manufactured by ACS and the NIR manufactured
by Scimed. The liner 10 is attached to a portion of the anchor 12
with an adhesive, mechanical interconnection, thermal bond, suture
or the like, or fused or soldered with radiopaque wire or ribbon.
The liner 10 may, of course, be attached in any other manner. The
liner 10 may also be encapsulated between layers of expanded
PTFE.
[0079] The anchor 12 and liner 10 may form a continuous,
cylindrical shape in the expanded position (FIG. 19) or the anchor
12 may have a tapered shape (FIG. 20). The tapered shape of the
anchor 12 may be useful when used in the carotid arteries with the
small end positioned in the internal carotid artery and the large
end in the common carotid. A method of forming the expanded shape
of FIG. 20 is for the anchor 12 to have a larger diameter than the
liner 10 so that the liner 10 holds an end of the anchor 12 at a
smaller diameter. For example, the anchor 12 may be a stent having
an 8 mm diameter with the liner 10 having a 6 mm expanded diameter
so that the liner 10 holds the end 11 of the anchor 12 to about 6
mm. Alternatively, the anchor 12 could be designed to expand to
different predetermined diameters at different points along its
length by varying strut lengths along its length.
[0080] The anchor 12 is positioned within an anchor retention
catheter 22 (FIG. 2). The anchor 12 is naturally biased to the
expanded condition of FIG. 3 and is held in the collapsed position
by the retention catheter 22. The anchor 12 is deployed by
retracting the catheter 22 while an inner element 24 holds the
anchor 12 at the desired location in the vessel. The liner 10 is
advanced over the guidewire 15 which is advanced ahead of the
catheter 22.
[0081] The anchor 12 may be deployed to extend into the common
carotid artery at the bifurcation of the external and internal
carotid arteries (FIG. 2) or may be contained entirely within the
internal carotid artery (FIG. 21-23). The anchor 12 may also be
deployed by inflating a balloon 27 as shown in FIG. 21 or may be a
shape memory material which is heat activated. When using a balloon
27 to expand the anchor 12, the anchor 12 is preferably a
conventional nitinol or stainless steel stent although any suitable
stent or device may be used. The balloon 27 is preferably compliant
so that a proximal portion of the balloon 27 expands to occlude the
vessel as shown in FIG. 21 before expansion of the anchor 12.
Alternatively, the balloon could be non-compliant but designed to
inflate at a lower pressure than that required to expand the stent.
By occluding the vessel, blood flow through the vessel is stopped
so that even if plaque is released the plaque will not flow
downstream. Further inflation of the balloon 27 (using inflation
source 39) expands the anchor 12 into engagement with the vessel
wall (FIG. 22). Any of the embodiments of the liner 10 described
herein may be used with balloon or self-expanding anchors 12 and
stents 26.
[0082] After the anchor 12 has been expanded, the liner 10 can be
configured to automatically open with blood pressure (FIG. 3).
Alternatively, the catheter 22 may be advanced through the liner 10
to partially open the liner 10. The device, such as the stent 26,
may also be advanced through the liner 10 to open the liner 10. The
liner 10 protects the vessel to prevent intravascular devices from
dislodging plaque when passing through the vessel. The distal end
of the liner 10 may also be opened with an elongate element 29,
such as a nitinol wire, advanced into the liner 10 to open the
liner 10 as shown in FIG. 26A. The element 29 may be advanced and
retracted independently with an inner actuator 31.
[0083] Referring to FIGS. 26B and 26C, the elongate element 29A may
also be advanced into a pocket 35 in liner 10A. The pocket 35 is
preferably formed by simply inverting or everting the end of the
liner 10A and attaching the end to another part of the liner 10A to
form the pocket 35. The elongate clement 29A passes through a tube
41, preferably a hypotube, polymer tube or composite tube, which is
releasably attached to the pocket 35. The tube 41 is preferably
released by heat, electrolytic detachment, mechanical detachment,
dissolution of a bond by blood, or retraction of a retention cord
although any suitable method may be used.
[0084] The elongate element 29A is preferably made of a
superelastic material, such as nitinol, which forms a loop 47 in
the expanded position. The elongate element 29A is contained within
the tube 41 when the liner 10A is advanced through the vasculature.
The liner 10A is advanced over the guidewire 15 by pushing the tube
41. When the user is ready to expand the proximal end of the liner
10A, the element 29A is advanced into the pocket 35 so that the
loop 47 opens the liner 10A as shown in FIGS. 26C and 26D. After
opening the proximal end of the liner 10A, the liner 10 may be used
in any manner described herein. For example, the stent 26 may be
advanced into the liner 10A to open the narrowed region of the
blood vessel as described in further detail below and shown in
FIGS. 26D and 26E.
[0085] When the device introduced into the liner 10 is the stent
26, the stent 26 is preferably expanded to open the narrowed
portion of the vessel as shown in FIG. 25. The stent 26 is mounted
to a balloon 33 which is coupled to an inflation source 37 (FIG. 1)
for inflating the balloon 33. The stent 26 is preferably a
conventional nitinol or stainless steel stent. The delivery
catheter 22 is preferably introduced into the liner 10 as shown in
FIG. 27 with the distal end of the catheter 22 positioned beyond
the end of the liner 10. The catheter 22 is then retracted to
expose the distal end of the stent 26. The distal end of the stent
26 is preferably opened first so that plaque is trapped between the
anchor 12 and stent 26 when expanding the rest of the stent 26. The
liner 10 may have the openings 25 (FIG. 5) which effectively filter
blood trapped behind the liner 10 and help to equalize pressure on
opposite sides of the liner as the stent 26 is expanded. The
catheter 22 may also be used to deliver a distal anchor 43 which
holds the distal end of the liner 10 open as shown in FIGS. 29-31.
Another stent 45 can then be delivered to expand the liner 10
between the anchor and distal anchor 43 (FIGS. 32 and 33).
[0086] Referring to FIGS. 34-39, the proximal end of the liner 10
may be expanded by delivery catheter 50 and then released so that
the anchor 12 is not required. The catheter 50 has an expanding
section 32 which is preferably inflatable but may also be
mechanically actuated. The expanding section 32 is coupled to a
lumen for inflating the expanding section 32. The liner 10 is
attached to the expanding section 32 with any suitable connection
such as glue, suture, or soldered with radiopaque wire or ribbon.
The liner 10 is preferably attached to the expanding section 32
with a thread 34 which passes through the liner 10 and expanding
section 32. An end of the thread 34 is pulled to release the liner
10.
[0087] The expanding section 32 is inflated to expand the proximal
end of the liner 10 as shown in FIG. 35. The stent 26 or other
device may then be passed through the liner 10 to open the liner 10
further as shown in FIG. 35. Referring to FIG. 38, the stent 26 is
partially expanded so that the liner 10 is held firmly in place by
the stent. The liner 10 is then detached by pulling the thread 34
and the stern 26 is fully expanded. Referring to FIG. 40, the
device may also be a filter 36 which is advanced through the liner
10 to trap dislodged plaque during an angioplasty, stent or other
procedure. The liner 10 may then be removed before removing the
filter 36 or may be used to line the vessel when deploying the
stent 26.
[0088] Referring to FIGS. 41-44, the liner 10 may also be everted
when moving from the collapsed to expanded positions. The liner 10
has the anchor 12 which is self-expanding and held in the collapsed
position by retention catheter 37. Pusher element 38 holds the
anchor 12 in place while retracting the retention catheter 37. A
proximal end 40 of the liner 10 is releasably attached to an inner
member 42. The liner 10 is pressurized, preferably with saline,
using lumen 44 in the pusher element 38. Once the liner 10 is
pressurized, the inner member 42 is advanced so that the liner 10
everts and moves through the vessel as shown in FIGS. 42-43. An
advantage of the everting liner 10 is that sliding forces between
the liner 10 and the vessel wall are reduced when advancing the
liner 10.
[0089] After the liner 10 has been fully everted, the retention
catheter 37 is retracted so that the anchor 12 expands and holds
the proximal end of the liner 10 open. The liner 10 is then
detached from the inner member 42. The liner 10 may have a
mechanical connection which is released with a push rod or
guidewire 43. The liner 10 may also have a severable bond with the
inner member 42 such as a thermally, chemically or electrolytically
severable bond using the guidewire 43. The device, such as the
stent 26, is then delivered through the liner 10.
[0090] Referring now to FIGS. 45 and 46, the liner 10 may also be
held open slightly at the proximal end 11 by delivery catheter 60.
The proximal end 11 of the liner is preferably held open to a
diameter of 6 mm to 8 mm or 4 Fr to 7 Fr. One or more filaments 62
hold the liner to the catheter 60. The liner 10 extends over the
distal end of the catheter 60 but may also be mounted inside the
catheter 60. The filaments are shown separated from the body of the
catheter 60 for clarity but would, of course, either pass through
the catheter or be held close to the catheter 60. The distal end of
the stent 26 is inflated first to trap the plaque behind the liner
10 and reduce flow around the liner 10. The rest of the stent 26 is
then expanded in the conventional manner.
[0091] Referring to FIG. 47, another catheter 70 for delivering the
liner 10 is shown wherein the same or similar reference numbers
refer to the same or similar structure. The catheter 70 operates
similar to catheter 22 described above in that the liner 10 is
mounted to the self-expanding anchor 12. The anchor 12 is held in
the collapsed position of FIG. 47 by an outer wall 72 of the
catheter 70. The outer wall 72 is retracted to expose the anchor 12
and permit the anchor 12 to expand.
[0092] The liner 10 is positioned between a flexible sheath 74 and
an inner tube 76. The sheath 74 and inner tube 76 prevent the liner
10 from contacting the walls of the vessel and guidewire 15 when
the liner 10 is advanced through the vasculature. The sheath 74 and
tube 76 also hold the liner 10 in the collapsed position although
the liner 10 may be collapsed without requiring the sheath 74 and
tube 76. The sheath 74 is attached to the outer wall 72 and is
retracted together with the outer wall 72.
[0093] A shaft 80 extends through the catheter 62 and a flexible
shaft extension 82 extends from the shaft 80. The shaft extension
82 and inner tube 76 provide a relatively flexible distal portion
to navigate tortuous vessels such as the cerebral vasculature. The
flexible shaft extension 82 may be a coil 84 as shown in FIG. 47 or
may be a tube 86 of material as shown in FIG. 48. A distal portion
88 of the catheter 70, which extends from the distal end of the
shaft 80, is preferably more flexible than a proximal portion 90
which terminates at the end of the shaft 80.
[0094] Referring to FIG. 47, the guidewire 15 passes through slots
93, 95 in the outer wall 72 and shaft 80 for loading the device on
the guidewire 15. Referring to FIG. 48, the guidewire 15 may also
pass through slots 92, 97, 99 in the outer wall 72, inner tube 76
and shaft extension 82. The catheter 70 may, of course, have a
continuous lumen which extends to the proximal end of the catheter
70. Referring again to FIG. 47, a handle 94 is attached to the
outer wall 72 and is pulled relative to the shaft 80 to retract the
sheath 74 and outer wall 72. The outer wall 72 is preferably made
of high density polyethylene having a thickness of about 0.005 inch
and an outer diameter of 0.040 to 0.070 inch, preferably about
0.055 inch. The outer wall 72 preferably has a length of 110 to 150
cm and preferably about 135 cm. The sheath 74 is preferably made of
linear low density polyethylene having a wall thickness of about
0.002 inch and an outer diameter of about 0.049 inch. The inner
tube 76 is preferably made of polyimide having a wall thickness of
0.0005 to 0.001 inch and an outer diameter of 0.014 to 0.026 inch,
more preferably 0.018 to 0.024 inch and most preferably about 0.022
inch. The liner 10 is collapsed to have a diameter, length,
thickness and length to thickness ratios as described above when
mounted to the tube 76. The shaft 80 is preferably a 0.022 inch
diameter stainless steel mandrel and the shaft extension 82 is
preferably a stainless steel coil. The shaft extension is fused to
the inner tube 76 (FIG. 47). The extension 82 may also be a tube of
linear low density polyethylene which is extruded and then
irradiated with 25/30 Mrads to an outer diameter of about 0.040 and
a wall thickness of about 0.018 inch (FIG. 48). Any other suitable
materials may be used without departing from the scope of the
invention.
[0095] The catheter 70 and liner 10 are used in substantially the
same manner as the catheters and liners 10 described above and the
discussion above is equally applicable here. The liner 10 is
advanced over the guidewire 15 to a narrowed region of a blood
vessel such as the internal carotid artery. The liner 10 and
catheter have a small profile, as discussed above and incorporated
here, so that the liner 10 may be advanced into the narrowed region
without dislodging plaque. When the liner 10 is at the desired
location, the handle 94 and shaft 80 are manipulated to retract the
sheath 74 and the outer wall 72. When the outer wall 72 and sheath
74 are retracted, the anchor 12 is free to expand. The liner 10 may
then be used in the manner described above. For example, the stent
26 or filter 36 may be advanced into the liner 10.
[0096] Referring to FIG. 49, another catheter 100 for delivering
the liner 10 is shown. The catheter 100 has the self-expanding
anchor 12 which is held in the collapsed position by a collar 102.
An arm 104 is attached to the collar 102 which in turn is attached
to a first core-wire 106. The first core wire 106 passes through a
shaft 108 which has a handle 110 mounted to the proximal end. The
handle 110 is retracted to pull the core wire 106, first arm 104
and collar 102 for releasing the self-expanding anchor 12.
[0097] A tube 112 is fused to the shaft 108 and an inner tube 114
is attached to the tube 114. The arm 104 travels in a slot 116 in
the tube 114 to stabilize retraction of the collar 102. The tube
112 and inner tube 114 form a lumen 118 through which the guidewire
15 passes.
[0098] Referring to FIG. 50, the distal end of the liner 10 is
locked into a fold 120 at the end of the inner tube 114. A wire
loop 122 holds the liner 10 in the fold 120. The wire loop 122 is
preferably attached to the collar 102 with a wire 124 embedded in
the collar 102. The wire loop 122 is retracted together with the
collar 102 so that the distal end of the liner 10 is released as
the collar 102 is retracted. The wire loop 122 is preferably a
0.005 inch diameter stainless steel wire. The fold 120 is
preferably made of silicone although other suitable materials may
be used. The shaft 108 is preferably made of stainless steel
hypotube having a wall thickness of about 0.005 inch and an outer
diameter of about 0.024 inch. The tube 112 is preferably made of
linear low density polyethylene having a wall thickness of about
0.004 inch and an outer diameter of about 0.040 inch. The inner
tube 114 is preferably made of polyimide having a thickness of
0.0005 inch and an outer diameter of about 0.022 inch. The liner 10
is deployed and used in substantially the same manner as described
above and the discussion above is applicable here.
[0099] The present invention is also directed to kits 124 which
include various assemblies as described above. For example, the kit
124 may include the liner 10, delivery catheter 22 and instructions
for use 126 setting forth any of the methods described herein as
shown in FIG. 51. The kits may, of course, also include the
stent(s) 26, anchors 12 and stent delivery catheter(s) 22 and/or
the filter 36 as well. The kits 124 will usually include a
container 126, such as a pouch, tray, box, tube, or the like, which
contains the devices as well as the instructions for use 128. The
instructions for use 128 may be set forth on a separate
instructional sheet within the package or printed in whole or in
part on the packaging itself. Optionally, other system components
useful for performing the methods of the present invention could be
provided within the kit 124, including guidewires, introductory
sheaths, guiding catheters, and the like. Any of the devices
described herein may form a kit with instructions setting forth a
method of the present invention.
[0100] While the above is a complete description of the preferred
embodiments of the invention, various alternatives, modifications,
and equivalents may be used. Therefore, the above description
should not be taken as limiting the scope of the invention which is
defined by the appended claims. For example, any of the delivery
catheters may have a balloon for occluding the vessel while
delivering the liner or advancing the device through the liner and
any of the liners may have perforations to filter blood or may be
made of a tightly woven material. Furthermore, the preferred
dimensions described herein with respect to any of the embodiments
is equally applicable to other embodiments.
* * * * *