U.S. patent application number 11/248362 was filed with the patent office on 2006-02-16 for guidewire loaded stent for delivery through a catheter.
This patent application is currently assigned to Counter Clockwise, Inc.. Invention is credited to Stephen Hebert, Marc-Alan Levine.
Application Number | 20060036309 11/248362 |
Document ID | / |
Family ID | 27753892 |
Filed Date | 2006-02-16 |
United States Patent
Application |
20060036309 |
Kind Code |
A1 |
Hebert; Stephen ; et
al. |
February 16, 2006 |
Guidewire loaded stent for delivery through a catheter
Abstract
A method of delivering a stent comprising providing an elongate
guide having a stent coaxially supported on the guide for placement
and movement by the guide, providing a tubular sheath member,
advancing the elongate guide into the body to provide initial
access to a preselected treatment site within the body and to carry
and deliver the stent to position the stent at the treatment site,
and exposing the stent from the tubular sheath member to enable the
stent to move from a first reduced diameter position to a second
expanded position.
Inventors: |
Hebert; Stephen; (San
Francisco, CA) ; Levine; Marc-Alan; (Pottstown,
PA) |
Correspondence
Address: |
Neil D. Gershon
29 Quaker Ridge Road
Stamford
CT
06903
US
|
Assignee: |
Counter Clockwise, Inc.
|
Family ID: |
27753892 |
Appl. No.: |
11/248362 |
Filed: |
October 11, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10087127 |
Feb 28, 2002 |
|
|
|
11248362 |
Oct 11, 2005 |
|
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Current U.S.
Class: |
623/1.11 |
Current CPC
Class: |
A61F 2/958 20130101;
A61M 2025/09008 20130101; A61F 2/95 20130101; A61F 2/966 20130101;
A61M 25/09 20130101; A61F 2002/9583 20130101; A61M 2025/09183
20130101 |
Class at
Publication: |
623/001.11 |
International
Class: |
A61F 2/06 20060101
A61F002/06 |
Claims
1-22. (canceled)
23. A method of delivering a stent within a body comprising:
providing an elongate guide having a proximal end, a distal end, a
length therebetween, and a radially expandable stent coaxially
supported on the elongate guide for placement and movement by the
elongate guide; providing a tubular sheath member; advancing the
elongate guide into the body to provide initial access to a
preselected treatment site within the body and to carry and deliver
the stent to position the stent at the treatment site, the tubular
sheath member covering at least part of the stent during
advancement through the body; and exposing the stent from the
tubular sheath member to enable the stent to move from a first
reduced diameter position to a second expanded position.
24. The method of claim 23, wherein the step of advancing the
elongate guide includes the step of advancing the elongate guide
into a lumen of a catheter.
25. The method of claim 23, further comprising the step of
providing radiopaque marker bands on the elongate guide to visually
aid placement of the stent.
26. The method of claim 23, wherein the step of exposing the stent
comprises retracting the tubular sheath over the stent as an
internal diameter of the sheath accommodates an external diameter
of the stent.
27. The method of claim 23, wherein the step of providing an
elongate guide having a stent includes providing the stent on a
reduced diameter portion of the elongate guide to reduce the
overall profile of the stent delivery assembly.
28. The method of claim 23, wherein the elongate guide includes
first and second stops, and wherein in the step of advancing the
elongate guide, stent movement is restricted by the first and
second stops and the stent is movable between the stops.
29. The method of claim 23, wherein the guide has a diameter
ranging from 0.007 to 0.014 inches and the step of advancing the
elongate guide into the body includes the step of advancing the
guide into the intracranial vasculature.
30. The method of claim 23, wherein the step of providing an
elongate guide further comprises the step of providing the elongate
guide with proximal and distal stop for maintaining the stent on
the elongate guide.
31. The method of claim 30, wherein the step of exposing the stent
comprises retracting the tubular sheath.
32. A method of delivering a stent within a hollow body organ
comprising: providing a stent delivery assembly including an
elongate guide in the form of a wire or hypotube, a stent mounted
on the elongate guide proximal of a distalmost tip of the guide,
and a tubular sheath for covering a least a portion of the stent
during advancement of the elongate guide through the body;
inserting the elongate guide, stent and tubular sheath into the
body; initially advancing the elongate guide into the body to
provide initial access to an area of stenosis or aneurysm; further
advancing the elongate guide without passage over a guidewire to
cross the stenosis or aneurysm to enable positioning of the stent
at the stenosis or aneurysm, the tubular sheath covering at least
part of the stent during advancement through the body; and exposing
the stent from the tubular sheath to enable the stent to move from
a first reduced diameter position to a second expanded position to
treat the stenosis or aneurysm.
33. The method of claim 32, wherein the step of exposing the stent
comprises retracting the tubular sheath.
34. The method of claim 32, wherein the elongate guide includes
first and second stops, and wherein in the step of advancing the
elongate guide, stent movement is restricted by the first and
second stops and the stent is movable between the stops.
35. The method of claim 32, wherein the step of providing a stent
delivery assembly comprises providing the stent on a reduced
diameter portion of the elongate guide to provide a reduced profile
of the stent delivery assembly.
36. The method of claim 32, further comprising the step of
withdrawing the elongate guide and tubular sheath after movement of
the stent to the second expanded position.
Description
TECHNICAL FIELD OF THE INVENTION
[0001] The present invention relates generally to catheters and
intravascular medical procedures. More particularly, it relates to
methods and apparatus for delivering a stent through a catheter by
way of a guidewire delivery device.
BACKGROUND ART OF THE INVENTION
[0002] Intravascular stents are well known in the medical arts for
the treatment of vascular stenoses. Stents are prostheses which are
generally tubular and which expand radially in a vessel or lumen to
maintain its patency. For deployment within the body's vascular
system, most stents are mounted onto a balloon angioplasty catheter
for deployment by balloon expansion at the site of a dilated
stenosis or an aneurysm. Self-expanding stents, which typically
expand from a compressed delivery position to its original diameter
when released from the delivery device, generally exert a radial
force on the constricted portion of the body lumen to re-establish
patency. One common self-expanding stent is manufactured of
Nitinol, a nickel-titanium shape memory alloy, which can be formed
and annealed, deformed at a low temperature, and recalled to its
original shape with heating, such as when deployed at body
temperature in the body.
[0003] To position a stent across an area of stenosis or an
aneurysm, a guiding catheter having a preformed distal tip is
percutaneously introduced into the vascular system of a patient by
way of, e.g., a conventional Seldinger technique, and advanced
within the vasculature until the distal tip of the guiding catheter
is seated in the ostium of a desired artery. A guidewire is then
positioned within an inner lumen of a dilatation catheter and then
both are advanced through the guiding catheter to the distal end
thereof. The guidewire must first be advanced out of the distal end
of the guiding catheter into the patient's coronary vasculature
until the distal end of the guidewire crosses a lesion to be
dilated, then the catheter having a stent positioned on the distal
portion is advanced into the patient's vasculature over the
previously introduced guidewire until the stent is properly
positioned across the lesion. Once in position, the stent may be
released accordingly.
[0004] It is generally desirable to have catheters which present
small cross sectional diameters to enable access into small sized
vessels. However, conventional techniques and apparatus typically
require the use of a guidewire for the desirable placement of the
catheter and stent within the vasculature. Thus, conventional
catheters typically require a separate lumen within the catheter
body to allow for the passage of a guidewire therethrough. This
separate lumen necessarily adds to the cross sectional profile of
the device. Yet vasculature having a tortuous path and/or a small
diameter, such as the intracranial vasculature, present problems
for the conventional stenting catheter. Accordingly, a highly
flexible stenting apparatus which is capable of accessing tortuous
regions and which presents a small cross section is needed.
SUMMARY OF THE INVENTION
[0005] A highly flexible stent delivery assembly is described
below. The assembly has the desirable characteristics of guidewires
in traversing tortuous vasculature, including small cross sectioned
vessels. The stent delivery assembly of the present invention is
thus able to deliver and place a stent anywhere in the vasculature
or within the body that is readily accessible by a guidewire but is
not normally accessible by a stenting catheter body which would
ride over such a guidewire.
[0006] The stent delivery assembly may typically comprise a
guidewire body which is preferably covered at least in part by a
retractable sheath. A radially expandable stent is disposed
directly in contact about the guidewire preferably near or at the
distal end of the guidewire. The retractable sheath preferably
covers the entire stent during deployment and placement, and is
retractable proximally to uncover or expose the stent for radial
expansion. A pair of optionally placed radio-opaque marker bands
may be located on either side (distally or proximally) or both
sides of the stent on the guidewire body.
[0007] The sheath may have a flush port, which is in fluid
communication with the distal end of the assembly, located near the
proximal end of the sheath. The flush port enables a fluid, e.g.,
saline, to be passed through the assembly prior to insertion into
the vasculature for flushing out air or debris trapped between the
sheath and guidewire. It may also be used to deliver drugs or
fluids within the vasculature as desired.
[0008] Because the guidewire body, rather than a catheter body,
carries and delivers the stent through the vasculature, the stent
may be placed almost anywhere in the body accessible by a
conventional guidewire. This may include, e.g., the tortuous
intracranial vasculature as well as, e.g., the more accessible
coronary vasculature. Furthermore, the assembly, which may include
the guidewire, sheath, and stent, may be introduced into a wide
variety of conventional catheters. This portability allows for
flexibility in using the same type of assembly in an array of
conventional catheters depending upon the desired application and
the region of the body to be accessed.
[0009] The sheath may be made from various thermoplastics, e.g.,
PTFE, FEP, Tecoflex, etc., which may optionally be lined on the
inner surface of the sheath or on the outer surface of the
guidewire or on both with a hydrophilic material such as Tecoflex
or some other plastic coating. Additionally, either surface may be
coated with various combinations of different materials, depending
upon the desired results. It is also preferably made to have a wall
thickness of about, e.g., 0.001 in., thick and may have an outer
diameter ranging from about 0.0145 to 0.016 in. or greater. The
sheath may be simply placed over the guidewire and stent, or it may
be heatshrinked to conform closely to the assembly.
[0010] The guidewire body may be made of a conventional guidewire
or it may also be formed from a hypotube having an initial diameter
ranging from 0.007 to 0.014 in. Possible materials may include
superelastic metals and alloys, e.g., Nitinol, or metals such as
stainless steel, or non-metallic materials, e.g., polyimide. The
hypotube may be further melted or ground down, depending upon the
type of material used, into several sections of differing
diameters. The distal end of the guidewire may be further tapered
and is preferably rounded to aid in advancement through the
vasculature. Radio-opaque coils may be placed over a portion of
distal end to aid in radiographic visualization.
[0011] The stent may be configured to be self expanding from a
constrained first configuration when placed upon guidewire to a
larger expanded second configuration when deployed. When the sheath
is retracted proximally, the stent preferably self expands to a
preconfigured diameter of, e.g., about 0.060 in. (1.5 mm), and up
to a diameter of about 0.315 in. (8 mm). Various materials may be
used to construct the stent such as platinum, Nitinol, other shape
memory alloys, or other self expanding materials.
[0012] Other variations may include a guidewire which defines a
stepped section near the distal end of the guidewire. The stepped
section outer diameter is less than the uniform diameter defined by
the remainder of the guidewire. The stent may be placed over this
section while maintaining a flush outer diameter which may
facilitate delivery of the stent-guidewire assembly not only
through catheter body but within the vasculature. The guidewire may
be further formed into tapered section distally of the stepped
section.
[0013] When in use in tortuous pathways, such as intracranial
vessels, the guidewire assembly may be used with the sheath alone
or in combination with a delivery catheter. The catheter body may
be advanced within the vessel to a treatment location such as an
aneurysm. Once the catheter is near the treatment site, the
guidewire may be advanced out of the catheter and adjacent the
treatment site. The sheath may then be retracted proximally to
expose the stent to radially expand into contact with the walls of
the vessel. Alternatively, the sheath may be held stationary while
the guidewire and stent are advanced to expose the stent, e.g., as
when deploying a coil stent. The stent may be self expanding or
configured to expand upon the application of an electric current
with or without the sheath. In either case, once the stent has been
released from the guidewire and expanded, both the guidewire and
sheath may be withdrawn into the catheter body and removed from the
vicinity. The catheter may be left within the vessel to allow for
the insertion of additional tools or the application of drugs near
the treatment site.
[0014] Other variations may include an expandable balloon section
preferably located distally of the stent. In this case, treatment
preferably includes the expansion of the balloon first to mitigate
any occlusions within the vessel. The stent may then be released in
a manner similar to that described above. Once the balloon has been
deflated and the stent expanded, the assembly may be removed from
the vicinity.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1A shows a variation on the stent delivery assembly
where a guidewire has a stent disposed on the wire near its distal
end.
[0016] FIG. 1B shows another variation on the assembly where the
guidewire may have an expandable balloon located near the distal
end of the wire.
[0017] FIG. 2 shows a representative illustration of the guidewire
and stent assembly which is insertable within a catheter; the
assembly shows the guidewire surrounded by a partially retracted
sheath which exposes the stent.
[0018] FIG. 3 shows a cross sectioned side view of a variation of
the stent delivery assembly placed within a catheter body
lumen.
[0019] FIG. 4 shows a cross sectioned side view of another
variation of the stent delivery assembly also placed within a
catheter body lumen.
[0020] FIG. 5 shows a cross sectioned side view of yet another
variation of the stent delivery assembly having an expandable
balloon section.
[0021] FIGS. 6A to 6C illustrate an example of one method of
placing a stent within a hollow body organ using the guidewire
assembly.
[0022] FIGS. 7A to 7C illustrate an example of another method of
placing a stent within the hollow body organ in combination with an
expandable balloon.
DETAILED DESCRIPTION OF THE INVENTION
[0023] A stent delivery assembly having a small cross section and
which is highly flexible is described herein. As shown in FIG. 1A,
catheter assembly 10 is comprised of a conventional catheter body
12 having a distal end 14 and a proximal end 16. A fitting assembly
18 is attached to the proximal end 16 and may preferably have
various attachments, e.g., Luer lock 20, to allow for access to
catheter body 12 or the use of other instruments. Conventional
catheter body 12 shows guidewire assembly 22 being slidably
positioned therewithin. Assembly 22, which is described in further
detail below, is shown in this variation as having a guidewire body
24 preferably covered at least in part by a retractable sheath 26.
A radially expandable stent 28 is preferably disposed near the
distal end of guidewire 24. Stent 28 may also be placed between an
optional pair of radio-opaque marker bands 30, 32. One or both
marker bands 30, 32 may be used or they may be left off the
assembly entirely. The use of radio-opaque material allows for the
visualization of the assembly during placement within the
vasculature. Such visualization techniques may include conventional
methods such as fluoroscopy, radiography, ultrasonography, magnetic
resonance imaging, etc.
[0024] FIG. 1B shows the distal portion of catheter body 12 with
another guidewire variation 34 which has an optional angioplasty
balloon 36. As shown in this variation, balloon 36 is preferably
located distally of stent 28 and may be sufficiently deflated such
that sheath 26 may be placed over both stent 28 and balloon 36.
[0025] FIG. 2 shows a representative illustration of the stent
delivery assembly 40 removed entirely from the delivery catheter
body with guidewire 24 covered by sheath 26. Stent 28 is preferably
placed directly over guidewire body 24 and is covered by sheath 26.
Sheath 26 may have a flush port 42 located near the proximal end of
the sheath 26. Flush port 42 is preferably in fluid communication
with the distal end of the assembly 40 so that a fluid, e.g.,
saline, may be passed through the assembly 40 prior to insertion
into the vasculature for flushing out air or debris trapped between
the sheath 26 and guidewire 24. Flush port 42 may also be used to
deliver drugs or fluids within the vasculature as desired.
[0026] Because the guidewire body 24, rather than a catheter body,
carries and delivers stent 28 through the vasculature, the stent 28
may be placed almost anywhere in the body accessible by a
conventional guidewire. This may include, e.g., the tortuous
intracranial vasculature as well as, e.g., the more accessible
coronary vasculature. Furthermore, assembly 40, which may include
the guidewire 24, sheath 26, and stent 28, may be introduced into a
wide variety of conventional catheters. This portability of
assembly 40 allows for flexibility in using the same type of
assembly 40 in an array of conventional catheters depending upon
the desired application and the region of the body to be
accessed.
[0027] The sheath 26 may be made from various thermoplastics, e.g.,
PTFE, FEP, Tecoflex, etc., which may optionally be lined on the
inner surface of the sheath or on the outer surface of the
guidewire or on both with a hydrophilic material such as Tecoflex
or some other plastic coating. Additionally, either surface may be
coated with various combinations of different materials, depending
upon the desired results. Sheath 26 is preferably made to have a
wall thickness of about 0.001 in. thick, and optionally thicker,
and may have an outer diameter ranging from about 0.0145 to 0.016
in., or greater. Sheath 26 may also be placed over guidewire body
24 having a diameter of about 0.038 in. When placed over guidewire
body 24 and stent 28, it may be simply placed over to slide along
wire 24 or it may also be heatshrinked over the wire 24 and stent
28 to conform closely to the assembly.
[0028] A more detailed view of the guidewire assembly is shown in
the cross sectioned side view in FIG. 3. As seen, the distal end of
guidewire body 24 is shown loaded within sheath lumen 60 of sheath
26 and this assembly is shown as being disposed within catheter
lumen 62 of catheter body 12. As previously discussed, because
stent 28 is placed upon a guidewire body rather than a catheter
body, the assembly may be introduced into any part of the body
which is accessible by a conventional guidewire but which is not
normally accessible for stenting treatments.
[0029] The guidewire body 24 may be made of a conventional
guidewire and it may also be formed from a hypotube having an
initial diameter ranging from 0.007 to 0.014 in. The hypotube or
guidewire may be made from a variety of materials such as
superelastic metals, e.g., Nitinol, or it may be made from metals
such as stainless steel. During manufacture, a proximal uniform
section 50 of the hypotube may be made to have a length of between
about 39 to 87 in. (100 to 220 cm), preferably between about 63 to
71 in. (160 to 180 cm), having the initial diameter of 0.007 to
0.022 in., preferably 0.008 in. The hypotube may be further melted
or ground down into a tapered section 52, depending upon the type
of material used, which is distal to the proximal uniform section
50. Tapered section 52 may have a length of about 4 in. (10 cm) to
reduce the diameter down to about 0.002 to 0.003 in. The hypotube
may be further formed to have a distal uniform section 54 of about
2 in. (5 cm) in length over which the stent 28 is preferably
placed. Radio-opaque marker bands may optionally be placed either
distally 30 or proximally 32 of stent 28 to visually aid in the
placement of the stent 28, as is well known in the art.
Alternatively, distal and proximal marker bands 30, 32 may be
eliminated altogether. Marker bands 30, 32 may be used as blocks or
stops for maintaining the stent in its position along guidewire
body 24. Alternatively, if bands 30, 32 are omitted from the
device, stops or blocks may be formed integrally into the guidewire
body 24 or they may be separately formed from material similar to
that of guidewire body 24 and attached thereto.
[0030] Distal end 56 may be further tapered beyond distal uniform
section 54 to end in distal tip 58, which is preferably rounded to
aid in guidewire 24 advancement. A coil, preferably made from a
radio-opaque material such as platinum, may be placed over a
portion of distal end 56. Alternatively, a radio-opaque material,
e.g., doped plastics such as bismuth or tungsten, may be melted
down or placed over a portion of distal end 56 to aid in
visualization. Stent 28 is preferably made to be self expanding
from a constrained first configuration, as when placed upon
guidewire 24 for delivery, to a larger expanded second
configuration as when deployed within the vasculature. Stent 28 may
be constrained by sheath 26 to a diameter of, e.g., 0.014 in.,
while being delivered to a treatment site within the body, but when
sheath 26 is retracted proximally, stent 28 preferably self expands
to a preconfigured diameter of, e.g., about 0.060 in. (1.5 mm), and
up to a diameter of about 0.315 in. (8 mm). Various materials may
be used to construct stent 28 such as platinum, Nitinol, other
shape memory alloys, or other self expanding materials. Sheath 26
may also have drainage ports or purge holes 64 formed into the wall
near the area covering stent 28. There may be a single hole or
multiple holes, e.g., three holes, formed into sheath 26. Purge
holes 64 allow for fluids, e.g., saline, to readily escape from
inbetween sheath 26 and guidewire 24 when purging the instrument,
e.g., to remove trapped air or debris.
[0031] FIG. 4 shows a cross sectioned side view of another
variation 70 of the stent delivery assembly. As shown, guidewire
variation 70 is shown as being surrounded by sheath 26 and the
sheath-guidewire assembly is shown as being placed within catheter
lumen 62 prior to delivery of the stent. In this variation, the
guidewire may have a uniform section 72 like that described in FIG.
3 above. However, there is also a stepped section 74 defined in the
guidewire outer diameter near the distal end of the guidewire.
Within this section 74, the stepped outer diameter is less than the
uniform diameter defined by the guidewire uniform section 72. It is
over this stepped section 74 that stent 84 may be placed along with
optional distal and/or proximal marker bands 80, 82, respectively,
such that sheath 26 remains flush over this section. Maintaining a
flush outer diameter may facilitate delivery of the stent-guidewire
assembly not only through catheter body 12 but within the
vasculature. The guidewire may be further formed into tapered
section 76 distally of stepped section 74. And the guidewire may be
finally formed into a distal tip 78 over which coil 86 may be
optionally placed. Coil 86 may optionally be covered by a covering
88, e.g., a polymer or other plastic material, placed or
heatshrinked over the coil 86 and distal tip 78 to provide a smooth
section.
[0032] FIG. 5 shows a cross sectioned side view of yet another
variation of the stent delivery assembly having an expandable
balloon section. As shown, much of the guidewire is similar to
variations described above but with the addition of an expandable
balloon 36 which may be inflated to an expanded balloon 36'. The
variation shown may have a uniform section 90 which similarly
tapers down 92 into a distal uniform section 94, over which stent
28 may be placed. Although balloon 36 may be placed proximally of
stent 94, it is preferably located distally of stent 94, as shown.
When deflated, retractable sheath 26 may also be placed over
balloon 36 to provide a uniform profile. To accommodate the
inflation and deflation of balloon 36, a small inflation lumen (not
shown) may be defined within the body of the guidewire for the
passage of fluids into and out of the balloon 36. A coil may also
be optionally placed over distal end 96; alternatively, a
radio-opaque material may be melted down or placed over distal end
96.
[0033] In operation, the stent delivery guidewire may be used with
or without the catheter body to deliver the assembly
intravascularly. It is preferable that a catheter be used to
provide a pathway close to the treatment site. However, in tortuous
pathways, such as intracranial vessels, the guidewire device may be
used with the sheath alone if the catheter body presents too large
a cross section for delivery purposes. FIGS. 6A to 6C show an
example of the deployment of the guidewire assembly. Catheter body
12 may first be advanced within the lumen 102 of vessel 100 to a
treatment location, e.g., aneurysm 104. Once catheter body 12 has
reached a position near aneurysm 104, guidewire 24 may be advanced
through and out of catheter 12 with sheath 26 covering stent 28, as
seen in FIG. 6A. As guidewire 24 is advanced, stent 28 located on
guidewire 24 may be positioned via radio-opaque marker bands 30, 32
to the desired location, such as over the neck 106 of aneurysm 104.
Once guidewire 24 and stent 28 have been properly positioned,
sheath 26 may be retracted proximally to expose stent 28 to the
vascular environment, as shown in FIG. 6B.
[0034] Stent 28, as shown in FIG. 6C, may be left to radially self
expand into gentle contact with the walls of vessel 100 to occlude
the neck 106 of aneurysm 104 (as is well known in the art). Stent
28 may also be configured to expand upon the application of an
electric current actuated from a location external of the patient.
The current may be delivered to stent 28 via an electrical
connection or line (not shown) disposed within the body of
guidewire 24. Once the stent 28 has been released from the
guidewire body 24 and expanded into contact with vessel 100,
guidewire 24 and sheath 26 may be withdrawn into catheter body 12
and removed entirely from catheter 12 or the catheter 12 itself may
then be removed entirely from the body of the patient. If guidewire
24 and sheath 26 are removed only, catheter 12 may be left in
position within vessel 100 to allow for the insertion of additional
tools or the application of drugs near the treatment site.
[0035] Treatment may also be accomplished with the guidewire
variation having an expandable balloon section. FIG. 7A shows
vessel 110 which is stenosed with an obstruction 112. Once catheter
body 12 has been positioned within vessel 110, guidewire body 34
may be advanced out of catheter 12 while still covered by sheath
26. Balloon 36 may then be positioned adjacent to the obstruction
112 optionally guided by marker bands 30, 32. Once positioned,
balloon 36 may be expanded to balloon 36', as shown in FIG. 7B, to
open the stenosed vessel. After the obstruction 112 has been
opened, balloon 36 may be deflated and the guidewire body 34 may be
advanced distally to position sheath 28 adjacent to obstruction
112. Sheath 26 may then be retracted to expose stent 28 to expand,
as described above, into contact against obstruction 112 and vessel
110. FIG. 7C shows the placement of guidewire 34 and expanding
stent 28 over obstruction 112.
[0036] The applications of the guidewire assembly and methods of
use discussed above are not limited to the deployment and use
within the vascular system but may include any number of further
treatment applications. Other treatment sites may include areas or
regions of the body such as organ bodies. Modification of the
above-described assemblies and methods for carrying out the
invention, and variations of aspects of the invention that are
obvious to those of skill in the art are intended to be within the
scope of the claims.
* * * * *