NZ721317B2 - Deployment of stents within bifurcated vessels - Google Patents
Deployment of stents within bifurcated vessels Download PDFInfo
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- NZ721317B2 NZ721317B2 NZ721317A NZ72131712A NZ721317B2 NZ 721317 B2 NZ721317 B2 NZ 721317B2 NZ 721317 A NZ721317 A NZ 721317A NZ 72131712 A NZ72131712 A NZ 72131712A NZ 721317 B2 NZ721317 B2 NZ 721317B2
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- stent
- balloon
- lumen
- bifurcation
- catheter
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- 238000000034 method Methods 0.000 abstract description 45
- 230000003902 lesions Effects 0.000 description 21
- 238000010586 diagram Methods 0.000 description 20
- 210000004204 Blood Vessels Anatomy 0.000 description 8
- 239000003814 drug Substances 0.000 description 6
- 229940079593 drugs Drugs 0.000 description 6
- 200000000009 stenosis Diseases 0.000 description 6
- 230000036262 stenosis Effects 0.000 description 6
- 238000002788 crimping Methods 0.000 description 5
- 230000004048 modification Effects 0.000 description 4
- 238000006011 modification reaction Methods 0.000 description 4
- 200000000008 restenosis Diseases 0.000 description 4
- 210000001367 Arteries Anatomy 0.000 description 3
- 210000004351 Coronary Vessels Anatomy 0.000 description 3
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- 230000017531 blood circulation Effects 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
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- 239000000203 mixture Substances 0.000 description 2
- 230000002093 peripheral Effects 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 235000005273 Canna coccinea Nutrition 0.000 description 1
- 240000008555 Canna flaccida Species 0.000 description 1
- 206010072052 Plaque shift Diseases 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
- 238000002583 angiography Methods 0.000 description 1
- 230000000875 corresponding Effects 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/852—Two or more distinct overlapping stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
- A61F2002/067—Y-shaped blood vessels modular
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
Abstract
Systems and methods for deploying stents within bifurcated vessels in a true pantaloons configuration (Kamat technique) are disclosed. A device includes a first balloon catheter (1201) around which a first stent (1202) is positioned and a second balloon catheter (1203) around which a second stent (1204) is positioned. A first lumen in the first balloon catheter is configured to house a first guide wire (410), and a second lumen in the second balloon catheter is configured to house a second guide wire (420). A third stent (440) is positioned around both the first and second balloon catheter. The first, second and third stents are separate components. The third stent partially overlaps the first stent and the second stent. 204) is positioned. A first lumen in the first balloon catheter is configured to house a first guide wire (410), and a second lumen in the second balloon catheter is configured to house a second guide wire (420). A third stent (440) is positioned around both the first and second balloon catheter. The first, second and third stents are separate components. The third stent partially overlaps the first stent and the second stent.
Description
DEPLOYMENT OF STENTS WITHIN BIFURCATED VESSELS
CROSS-REFERENCE TO RELATED APPLICATIONS
This specification claims the benefit of the filing date of U.S. Provisional
Patent Application No. 61/528,968, which is titled "Systems and Methods for Deploying
Steins within Bifurcated Blood Vessels" and was filed on August 30, 2011, the disclosure of
which is hereby incorporated by reference herein in its entirety.
TECHNICAL FIELD
This specification relates generally to systems and methods for stent
deployment, and, more particularly, to systems and methods for deploying stents within
bifurcated vessels.
BACKGROUND
Bifurcation occurs when a vessel (or main branch) splits into two separate
blood vessels (or side branches). Typically, the two side branches are smaller than the main
branch. In the case of blood vessels, plaque buildup in the bifurcated region may cause
stenosis or otherwise compromise blood flow. These types of lesions may occur within the
main branch as well as in the side branches.
Over the years, a few techniques have been developed to attempt to treat
lesions at bifurcations. An example of a bifurcation stent delivery device is described in U.S.
Patent Application Publication No. 2005/0209673 (Shaked). Specifically, Shaked's device
uses an additional lumen to accommodate a secondary guide wire that is inserted into a side
branch at a bifurcation. The inventor hereof has recognized, however, that the exit point for
the secondary guide wire occurs at the midpoint of the device. As a result, the struts from the
exit point may get incorrectly aligned, which may hinder the deployment of a side branch
stent.
(Sequin).
Another bifurcation device is disclosed in U.S. Patent No. 7,686,845
device uses a self-expanding stent, which the inventor hereof has also recognized
Sequin's
tends to be difficult to maneuver and deploy, especially if the plaque burden in the vessel is
Sequin's stent are subject to grabbing on to plaque during
high. Moreover, the struts of
deployment, which may result in inaccurate placement of the stent, damage to the vessel,
plaque shift, dissection, or even plaque embolization.
SUMMARY
The currently existing limiting factors for bifurcation stenting can be
overcome by novel techniques described herein, which: a) accurately identify the location of
the carina in two dimensional angiographic views, b) accurately position the stents at the
carina, c) accurately deploy the stents in relation to the carina, d) position wires in the main
lumen and the side branches without going through stent struts, e) cover the entire area of the
bifurcation so as to get a smooth luminal outcome initially without plaque protruding within
the lumen (e.g., 100% coverage of the area is particularly important to obtain the anti-
restenosis benefit of drug eluting stents), f) avoid stent struts from protruding within the
lumen where blood flows — a problem associated with stent thrombosis, g) allow for
reintervention in the future to treat new lesions distally or restenosis of the bifurcation
without being hindered by the previously deployed bifurcation stents (e.g., the absence of
jailed side branches provides natural anatomic side branch access later), h) allows for
completion of a bifurcation stenting procedure with predictable, timely success without
complications in the hands of competent operators with common and adequate skills, i) result
in low radiation and limited contrast use, j) avoid the need for bypass surgery as the first
option or as a complication of the procedure, k) use available (albeit off-label) stent
technology to achieve successful results, and 1) creates the possibility that industry can adapt
these changes without the need to invent new stents, but instead by modification of existing
balloons and channels .
Systems and methods for accurately deploying stents within bifurcated vessels
100071
are disclosed. In an illustrative, non-limiting embodiment, a method may include inserting a
device into a bifurcated vessel ( i.e., a coronary or non-coronary blood vessel, a
tracheobronchial tree, a venous system, a ureter, etc.), the device including a balloon catheter
and a stent, the stent surrounding at least a portion of the balloon catheter, the balloon
catheter including a first lumen configured to accept a first guide wire, the first guide wire
exiting the device at a distal end of the balloon catheter, and the bifurcated vessel including a
main branch, a first side branch, a second side branch, and a carina region between the first
and second side branches.
PCTI1JS2012/052864
100081 The method may also include advancing the device within the main branch of
the bifurcated vessel over the previously placed first guide wire until the device reaches the
carina region. The first guide wire may be maneuvered into the first side branch and/or a
second guide wire may enter the second side branch. Also, the second guide wire may exit
the device immediately beyond the distal edge of the stent that surrounds the balloon catheter
from under the stent. The distal edge of the stent may be placed at or just ahead of the distal
tapered edge of the balloon (e.g., the proximal edge of a distally located tapered portion of
the balloon). As the stent approaches the carina of the bifurcation, the second wire may enter
the second side branch, thereby physically positioning the distal edge of the stent at the
carina.
100091 The method may further include deploying the stent within the main branch of
the bifurcated vessel by inflating the balloon when the stent is so positioned. In some cases,
the diameter of the stent and balloon may be sized for the main branch. The tapered portion
of the balloon may be in the first side branch such that it does not push the stent back if the
stent is located sufficiently at or slightly ahead of the tapered shoulder. As the balloon is
being deflated, the second wire that is under the stent exterior to the balloon may be advanced
forward into the second side branch. In this manner, each side branch receives a wire, and
both these wires are located within the lumen of the stent of the main vessel. Subsequently,
kissing balloons may be used to expand and/or splay this stent to conform to the wider lumen
at the bifurcation.
In some implementations, a bifurcation stent balloon device for accurate
[0010j
in vitro. Further, such a device
deployment at the bifurcation may have been pre-assembled
may include any available drug coated stent as well as non-drug coated, bare-metal stents
(although it is recognized that the latter may result in a higher likelihood of stenosis). The
method may also include reconfiguring the device prior to inserting the device into the
bifurcated vessel. This may include, for example, sliding the stent off of the balloon catheter.
The method may also include placing the second guide wire between an inner surface of the
stent and an outer surface of the balloon catheter, and sliding the stent back onto the balloon
catheter with the distal edge of the stein positioned at the distal, tapered edge of the balloon
as identified by a distal balloon marker, or the like). In some cases, the stem
catheter (e.g.,
may be crimped onto the balloon at its new distal forward location. The crimping of the stent
may be achieved, for example, by firmly winding a #2 silk suture over the stent.
MT/1[152012/052864
1.00111 In other implementations, a novel balloon catheter may include a second
lumen, the second lumen configured to accept the second guide wire, a portion of the first
guide wire exiting the device at the distal end of the balloon catheter in parallel with respect
to a portion of the second guide wire exiting the device at the tapered edge of the balloon
catheter. For example, an edge of the stent may be positioned at the tapered edge of the
balloon catheter. As such, the first guide wire may be configured to exit the first lumen at a
center of the distal portion of the balloon catheter, and the second guide wire may be
configured to exit the second lumen at a periphery of the balloon on the balloon catheter.
As such, the second wire may be maneuvered and/or advanced into the second
side branch as the stent approaches the bifurcation. It is noted that the crossing profile of
such a configuration may be suitable for numerous applications. The second wire lumen may
be placed under the stent and extend backwards to the hub of the balloon attached to the shaft
or free from the shaft up to the stent. Alternatively, the second lumen may be located only at
the balloon under the stent. In
the latter case, the second wire may be pre-positioned into the
second side branch with due care taken that the two wires remain parallel and do not wind
around the each other. If necessary, this parallel position of the wires may be accomplished,
for instance, using a dual lumen introducer device or the like.
In various situations, deploying the stent within the main branch of the
bifurcated vessel may include inflating the balloon catheter to deploy the stent while
maintaining access to the first side branch of the bifurcated vessel via the first guide wire
and/or to the second side branch of the bifurcation via the second guide wire. Moreover,
deploying the stent within the main branch of the bifurcated vessel may include applying a
first kissing balloon technique to expand and/or splay the distal end of the stent. The method
may then include deploying another stent within the first side branch of the bifurcated vessel
using the first guide wire and/or deploying another stent within the second side branch of the
bifurcated vessel using the second guide wire.
In some cases, the stent may be sized appropriately for each side branch
vessel. A kissing stent technique may be used with accurate placement of the stents using the
visualized splayed first stent in the main branch and the visualized proximal edge of the
stents in each side branch, so as to accurately deliver the stents at the canna. To avoid
damage to the vessels, high-pressure inflation of one gent (e.g., —12 atm) may be
accompanied with a lowering of the pressures in the other balloon (e.g., —3 atm). Thereafter,
—6 atm), and then both
balloons may be pulled back into the main branch stent and inflated in a similar fashion to
receiving a premanufactured assembled device including a balloon catheter and a stent, the
include placing the stent on the balloon catheter after adding a second guide wire between an
The method may also include advancing the balloon catheter within a vessel
first side branch and a second side branch of the bifurcation. Then, the method may include
delivering a second stent to the first side branch of the bifurcation using the first guide wire
and/or delivering a third stent to the second branch of the bifurcation using the second guide
In yet another illustrative, non-limiting embodiment, a device may include a
balloon catheter including a first lumen and a second lumen, the first lumen configured to
being inflated, may have a conical portion between the shoulder and the distal end.
BRIEF DESCRIPTION OF THE DRAWINGS
is a diagram of a bifurcated vessel.
FIGS. 2A-E are diagrams of dual-lumen balloon catheters according to some
(e.g.,
both balloons may be brought to the same medium pressures
may be deflated at the same time so as to leave the carina in a central position. The two
ensure that the splayed proximal stent and the two branch stents are pushed into the wall of
the vessel, thus leaving behind a smooth true pantaloons bifurcation configuration.
In another illustrative, non-limiting embodiment, a method may include
stent surrounding at least a portion of the balloon catheter, the balloon catheter including a
first lumen, the first lumen configured to accept a first guide wire. The method may also
inner surface of the stent and an outer surface of the balloon catheter. The method may
further include crimping the stent back onto the balloon catheter.
using the first guide wire until the balloon catheter stops at a carina of a bifurcation due, at
least in part, to the carina contacting the second guide wire, and deploying the stent between a
wire.
receive a first guide wire and the second lumen configured to receive a second guide wire, the
first lumen having a first exit at a center of a distal end of the balloon catheter, and the second
lumen having a second exit at a shoulder of the balloon catheter. The balloon catheter, upon
[00181 Reference will now be made to the accompanying drawings, wherein:
embodiments.
3 is a cross-sectional view of the balloon catheter according to some
some embodiments.
some embodiments.
FIG, 6 is a diagram of a bifurcation stent delivery device introduced into a
is a diagram of the bifurcation stent delivery device positioning a stent
stent accurately positioned across the carina according to some embodiments.
FIGS. 12A and 12B are diagrams of three stents being positioned at the
FIGS. 13A and 13B are simplified diagrams of an open-cell and a closed-cell
C is a diagram of a bifurcation stent delivery device employing a
FIG.
embodiments.
FIGS. 4A-H are diagrams of bifurcation stent delivery devices according to
is a flowchart of a bifurcation stent delivery technique according to
main branch toward a bifurcation lesion according to some embodiments.
at the carina of the bifurcation according to some embodiments.
is a diagram of the bifurcation stent delivery device deploying the stent
at the carina according to some embodiments.
is a diagram of the stent with the balloon removed and the expanded
is a diagram of kissing balloons used to splay the stent across the
carina according to some embodiments.
is a diagram of the stcnt fully splayed across the carina according to
some embodiments.
bifurcation according to some embodiments. Fig 12B demonstrating the final results of the
creation of a true pantaloons bifurcation stenting configuration.
stent according to some embodiments.
single-lumen catheter, according to some embodiments. Here the second wire is trapped
under the stent by crimping the stent over it.
PCT/U52012/052864
is a flowchart of a bifurcation stent delivery device assembly using a
single-lumen catheter with a closed-cell stent according to some embodiments.
is a flowchart of a bifurcation stent delivery device assembly using a
single-lumen catheter with an open-cell stent according to some embodiments.
FIGS. 16A-C are diagrams of alternative delivery devices according to some
embodiments.
10036] FIGS. 17A-B illustrate a three-stent delivery device according to an alternative
embodiment.
While this specification provides several embodiments and illustrative
drawings, a person of ordinary skill in the art will recognize that the present specification is
not limited only to the embodiments or drawings described. It should be understood that the
drawings and detailed description are not intended to limit the specification to the particular
form disclosed, but, on the contrary, the intention is to cover all modifications, equivalents
and alternatives falling within the spirit and scope of the claims. Also, any headings used
herein are for organizational purposes only and are not intended to limit the scope of the
description. As used herein, the word "may" is meant to convey a permissive sense
(i.e.,
meaning "having the potential to"), rather than a mandatory sense
(i.e., meaning "must").
Similarly, the words "include," "including," and "includes" mean "including, but not limited
to."
DETAILED DESCRIPTION
This specification discloses systems and methods for accurately deploying
stents within bifurcated vessels. Examples of "bifurcated vessels" include, but are not limited
to, bifurcated blood vessels (coronary, carotid, iliac, or other blood vessels), tracheobronchial
trees, venous systems, ureters, etc. Although the embodiments discussed below occasionally
refer to specific types of vessels (e.g., blood vessels), it should be understood that these
examples of intravascular stents are provided for sake of illustration only, and not by way of
limitation. Moreover, it should be noted that the various embodiments illustrated in the
figures and discussed below are not necessarily drawn to scale, but are instead presented with
dimensions intended facilitate their understanding.
PCT1US2012/052864
of the bifurcation while maintaining access to one or more side branches, and then deploying
implementations, these methods may be performed by employing at least two distinct types
catheter, as shown in ). The pre-manufactured models may include multiple balloons
manufactured models. For example, a secondary guide wire may be placed between the stent
A).
and a long tube catheter with an approximately 0.014-inch wire lumen or the like to facilitate
lumen FIGS. 16B and 16C). These various devices, as well as their corresponding
manufacturing and delivery methods, are described in turn below.
Stent Delivery With Multi-Lumen Balloon
In some embodiments, stent delivery devices may employ balloon catheters
manufactured with two or more lumens (the first group or type of devices described above).
of the balloon shaft, and may be configured to house a main
secondary guide wire. The exit point for the secondary lumen may be at the distal end of the
balloon, and may occur where the balloon tapers—i.e., at or near a "shoulder region" of the
balloon. This secondary guide wire may maintain access to a side branch of a bifurcated
vessel during a stent deployment procedure. In some embodiments, three stents may be
may maintain a
deployed, one in each branch of the bifurcation. The device
[00391 In various embodiments, the methods described herein include deploying a
stent at the main branch of a bifurcated vessel by positioning the stent accurately at the carina
one or more additional stents in the side branches of the bifurcation. In some
or groups of stent delivery devices. A first group of devices includes a balloon catheter
manufactured with two or more lumens or channels configured to accommodate two or more
separate guide wires (i.e., a dual-lumen catheter as shown in FIGS. 2A-D, or a triple-lumen
in some embodiments. A second group of devices includes alternatives to the pre-
manufactured dual-lumen catheter. An existing single-lumen balloon catheter may be
modified so that it is capable of performing the same or similar operations as the pre-
and a single-lumen balloon catheter in an "off-label" procedure (e.g., C).
Additionally or alternatively, a dual-balloon configuration with a single stent crimped over
two balloons may be designed to help position the stent at the carina (e.g.,
Additionally or alternatively, a stent may be crimped over a combination of a balloon catheter
accurate delivery at the carina while maintaining dual side branch access through the stent
(e.g.,
Catheters
For example, in a dual-lumen configuration, a main lumen may be located in the axial center
guide wire. A secondary lumen
may be located along the side of the balloon shaft, and may be configured to house a
low profile to
PCT/1JS2012/052864
ensure that it fits in the entity being treated (e.g., a coronary vessel or other type of vessel).
The stent(s) may be chosen, for example, based on the size of the vessel and the length of the
lesion.
In various embodiments, the stent may be positioned on the balloon so that the
stent is at the shoulder of the balloon, just as the balloon tapers. As the inventor hereof has
discovered, when the balloon is inflated for stent expansion, the portion of the balloon distal
to the stent should immediately taper and the balloon should not push the stent back from its
desired location within the vessel directly at the earina. In contrast, conventional stent
delivery systems typically place the stent in the center or middle of the balloon, with a —0.5 to
1 mm of balloon extending or "overhanging" proximal and distal to the stent. The distal
portion of the balloon beyond the distal edge of the stent is generally larger than either side
branch. During stent inflation, the ends of the balloon that are not covered by the stent
expand first. Since side branches are generally smaller than the main branch, when there is a
size mismatch of the distal balloon with respect to the size of the side branch vessel, the distal
balloon-end expansion in a conventional delivery system invariably displaces the stent away
from the carina. Again, at least in part because certain of the techniques described herein
allow accurate positioning of the stent at the earina of the bifurcation, these techniques
represent a significant improvement over conventional delivery systems. Conventionally,
because of branch vessel overlap, it is difficult to identify the true bifurcation. The bifurcation
seen by angiography may not accurately correspond to the true anatomical bifurcation. This
difficulty is overcome by the technique described herein, because the anatomical bifurcation
is physically identified. This not only guarantees that the stent is placed accurately at the
bifurcation, it also saves the patient from being exposed to additional contrast and radiation.
A 0.014-inch guide wire or the like may be placed in each lumen or channel of
the balloon. The assembled device may be placed in the vessel using the main guide wire.
As the device moves along main guide wire through the vessel, the secondary guide wire may
be guided into a side branch. The device may be advanced, for example, until it naturally
stops at the carina of the bifurcation due to the secondary wire positioned into the side
branch. At this point, the operator may know or sense that the device is positioned accurately
at the carina. For example, the secondary wire in the second side branch may be observed to
buckle slightly and a resistance to forward progress of the stent will be felt physically by the
operator. Additionally or alternatively, radiolucent markers or the like on the balloon shaft,
stent, and/or distal tip of the tube or channel under the stent may facilitate positioning of the
or PROMUS
maintained with the two guide wires. Next, a first kissing balloon technique may be used to
approximate diameters of each side branch so as to splay the stent appropriately without
damaging the side branches. Once the kissing balloons have been inflated, the stent in the
be deployed in a kissing manner into the side branches of the bifurcations. These two stents
may be positioned so that the proximal part of the respective stents is exactly at the carina. A
of the vessel.
For sake of illustration, a typical procedure for kissing stents deployment may
16 atm, the other balloon may be inflated to approximately —4 atm (and vice versa for the
enough to not damage the main vessel and yet capable of pre-dilating the distal side branches
[00451
to treat stenosis and/or other vessel conditions. Techniques for deploying these
stents accurately at bifurcated lesions are described below.
Turning now to
balloon during this procedure. Also, in some cases, the un-inflated stent may have a distal
marker or may be more visible because it is not inflated and/or because it is more radiolucent,
as is the case of platinum chromium stents (e.g., ION® ® stents).
The balloon catheter may then be inflated and the stent deployed. In this
manner, access to the side branch and main branch within the lumen of the stent may be
splay the stent to conform to the bifurcation. The two balloons may be sized as per the
main branch may be splayed across the carina. Thereafter, stents of the appropriate size may
second kissing balloon technique may be used to further inflate the branch stcnts and the
main vessel stent, and further cause opposition of the stents into the intima
High-pressure inflations may be used.
be conducted as follows. When one of the kissing balloons is inflated to approximately —10-
other stent). Thereafter, both balloons may be brought down to approximately —5-8 atm and
deflated at the same time to ensure that the carina is correctly positioned. It should be
understood, however, that the inflation pressures to be used are dependent on the size of the
vessel, the compliance of the inflating balloons, manufacturer recommendations, etc. In the
dual balloon stent configuration, for example, the two balloon sizes selected may be small
to facilitate the kissing stents to follow.
In various applications, a stent delivery device may be used to deploy stents
designed
100461 a diagram of a bifurcated vessel is depicted.
Generally, the lengths and diameters of the various elements of bifurcated vessel 100 may
vary depending upon their location in a patient's body. As illustrated, bifurcated vessel 100
vessel 100. Plaque 140 is illustrated along the surfaces or walls of bifurcated vessel 100 to
represent stenosis or other types of lesions.
Main guide wire lumen 230 may include exit 250, and may be configured to receive a first
(i.e.,
receive another guide wire (i.e.,
procedure. In some cases, lumen 280 or chamber 281 may at least partially surround main
(i.e., the axis) of catheter 200A, whereas end
260 of side lumen 240 may be located at or near
between proximal edge 270 of distal shoulder region 220 (or end 260) and distal edge 271 of
sometimes be referred to as a "tapered edge," "tapered shoulder," or "shoulder" of catheter
includes main branch 110, which splits between side branches 120A-B. Carina 130
represents a region of bifurcated vessel 100 where side branches 120A-B are joined together.
In some cases, carina 130 may also be referred to as a "vertex" or "crotch point" of bifurcated
(09471 is a diagram of a dual-lumen balloon catheter according to some
embodiments. In particular, balloon catheter 200A may include proximal tapered end 210
and distal tapered end 220. Catheter 200A may also include main or primary guide wire
lumen (or channel) 230 as well as side or secondary guide wire lumen (or channel) 240.
guide wire a main or primary guide wire — not shown) through main wire port 201.
Conversely, side guide wire lumen 240 may include end 260, and may be configured to
a side or secondary guide wire — not shown) through second
wire port 202. Balloon inflation port 203 may be utilized deliver dilute contrast or another
suitable fluid to lumen 280 or chamber 281 so as to inflate catheter 200A during a delivery
guide wire lumen 230.
As illustrated in , exit 250 of main lumen 230 through shaft portion
251 may be located at or near the center portion
(e.g., immediately after) proximal edge 270
of distal shoulder region 220 of catheter 200A. It may also be noted that catheter 200A tapers
distal shoulder region 220, which is where the balloon joins shaft 251 in an approximately
conical tapered fashion. Accordingly, proximal edge 270 of distal shoulder region 220 may
200A.
In some embodiments, proximal edge 270 may be defined as the point along
catheter 200A where it begins to taper into region 220. And in some cases, end 260 may be
located exactly at proximal edge 270. In other cases, end 260 may be located at a distance
from proximal edge 270 so that lumen 240 ends before edge 270 or extends beyond edge 270.
2A-2E may aid in such parallel placement of wires. In the configuration of , for
Twin Pass Dual access Catheter model 5200 by Vascular Solutions Inc.).
FIGS. 2B-E illustrates alternative embodiments of a dual-lumen balloon
shows side guide wire lumen 242 with first exit 262 located at or near
distal edge 272 of proximal tapered portion 210
located at or near proximal edge 270 of distal tapered portion 220
edge") of catheter 200C. As such, the embodiment of is a "universal" balloon
catheter with the capability to accurately deliver a stent located proximal or distal to the
shows an alternative configuration of side guide wire lumen 243 with
end 263 located at proximal edge 270 of distal tapered portion 220, but running alongside
ACT/US2012/052864
The individual guide wires may be placed through the main vessel and into the
two side branches of the bifurcation before the dual lumen stent balloon is loaded. In this
case, the guide wires should not be twisted around each other, which would obstruct the
movement of the stent balloon as it travels along the guide wires and through the main vessel
to the carina location. In some cases, the dual lumen catheter in the configuration of FIGS.
example, such parallel placement of the guide wires may be achieved beforehand (e.g.,
catheter. Particularly, shows side guide wire lumen 241 with end 261 located at
distal edge 272 of proximal tapered portion 210 of catheter 200B. In some cases, the
embodiment of may be used, for example to deliver a stent distal to the carina of a
bifurcated vessel (as shown in FIGS. 4D and 4E).
(i.e., a "first tapered edge") and end 260
(i.e., a "second tapered
carina.
main guide wire lumen 230 for a least a portion of the length of balloon catheter 200D.
shows yet another alternative configuration of a universal balloon
catheter 200E with two wire lumens; lumen 240 terminating at opening 260 at edge 270 and
lumen 244 terminating at opening 264 at edge 272.
Referring to a cross-sectional view of balloon catheter 200A of is depicted. In this embodiment, lumen 230 is usually located approximately at the center
of catheter 200A, and lumen 240 is located outside the perimeter of catheter 200A. In
alternative embodiments, lumen 240 may also be located along the perimeter but within
balloon catheter 200A. Again, end 260 of lumen 240 may be located at or near shoulder
determine an angle or degree of tapering of distal end 220 and to facilitate insertion of
different diameters may be available, and a user or operator may select a suitable one among
(e.g.,
expanded versions of the stent-balloon configuration in some situations.
PCT/U52012/052864
(i.e.,
region 270 of catheter 200A, near a point where catheter 200 begins to taper off
proximal edge 270 of distal shoulder region 220).
In various embodiments, radius 300 of catheter 200A may be designed so as to
catheter 200A in vessels of varying sizes. For example, a small radius 300 may reduce the
profile of catheter 200A. Conversely, a large radius 300 may allow bifurcations with large
angles and/or diameters to be properly treated using catheter 200A. In a number of
applications, the distal balloon end may taper from the shoulder onwards as rapidly as
technically feasible. Moreover, in some cases, a set of two or more catheters 200A with
the set based on a location within the patient's body where a stent procedure will be
performed coronary arteries may require low profile, etc.).
It should be noted that, except in FIGS. 6, 7, 16A-C and 17A (where the stent
balloon diagram represents an unexpanded balloon with the stent crimped on it), all other
balloon diagrams (FIGS. 2A-E, 3, and 4A-G) are shown with the balloon expanded
somewhat, but this is entirely for illustrative purposes. Fig 4H is a self-expanding stent and
does not require a balloon for deployment. Generally speaking, balloon lumen 281 is
collapsed when the stent is crimped on the balloon (i.e., the balloon is folded in an
unexpanded state under the crimped stent). FIGS. 4E, 8-11, 12A, and 17B may represent
is a diagram of bifurcation stent delivery device 400A according to
some embodiments. As illustrated, device 400A utilizes the balloon catheter 200A depicted
in . Specifically, stent 440 may be positioned on the outer surface of balloon catheter
200A. In some cases, a distal edge of stent 440 may be aligned with edge 270 of shoulder
region 220 on catheter 200A. Main guide wire 410 may be positioned in a vessel in a
location desired by the operator or surgeon. Note that in most instances, wire 410 may be
placed in the vessel across the lesion in the main branch 110 (shown in FIG 1) and further
across the first side branch 120-A (shown in , which is chosen because it is the more
difficult lesion to cross. Wire 420 may be placed across the other side branch 120B (shown
in beforehand or after the stent approaches the carinal bifurcation point 130 (shown in
.
100591
[00601
[00631
Main guide wire 410 is inserted through main lumen 230 of catheter 200A into
end 250 and out of proximal end 201 (shown in . Catheter 200A is then advanced
along guide wire 410 into the vessel and positioned as desired. Similarly, side guide wire 420
may be inserted through side lumen 240 of catheter 200A into end 260 and out end 202 (also
shown in . In other embodiments, as shown in FIGS. 2B and 2C, lumen 240 may
terminate at the distal shoulder 272 of tapered region 210, where side guide wire 420 may
exit through end 261 or exit 262 (shown in FIGS. 213 and 2C). Alternatively, the side
guidewire 420 may be introduced through the proximal end 202 into lumen 240 to exit from
the end 260, 261 or 262 as the case may be, after the catheter 200A has already been
advanced into the artery close to the carina.
shows an alternative configuration for bifurcation stent delivery
device 400B according to some embodiments. Specifically, device 400B employs balloon
catheter 200D shown in .
[00611 shows stent delivery device 400C where the second side guide wire
channel 244 is approximately the same length as the cylindrical portion of the balloon and
slightly longer than the stent 440 spanning from shoulder 272 to shoulder 270. In this
configuration, both wires 410 and 420 may be placed across the main branch and side
branches 120A and 120B (shown in before threading the guide wires into the stent
delivery device 400C. Wires 410 and 420 may be of approximately the same lengths
allowing for one catheter to be exchanged for another.
illustrates a bifurcation stent delivery device 400D using balloon
[00621
catheter 200B of . In this embodiment, as previously shown, side guide wire 420
may leave side guide wire lumen 240 through end 261. As such, this device configuration
may be particularly well suited for accurately placing stent 440 at the carina beyond the main
branch and into one of the side branches 120A or 120B (shown in .
shows device 400D positioned within side branch 120A beyond
carina 130. As device 400D is insertion into side branch 120A, guide wire 420 causes device
400D to stop at carina 130 with stent 440 accurately located at carina 130 and extending into
branch 120A. In some cases, such a technique may be used, for example, to preserve side
branches and/or to prevent jailing of the side branch—i.e., prevent the stent from deployed in
such a way as to block or partially block access to the side branch Besides accurate
positioning of the stent beyond the carina, the added advantage of this technique is that the
wire 420 maintains access to the side branch 120B in case side branch 120B needs
shows bifurcation stent delivery device 400F employing balloon
262) in lumen 242 for guide wire 420. For example, wire 420 may leave catheter 200C
through exit 260 (at or near edge 270 of distal tapered region 220) for placement of stent 440
carina and within a side branch.
[00651
center lumen 230 and side lumens 240 and 245. Each lumen is configured to hold a different
guide wire 410, 420, 430. As such, device 400G may be particularly well suited for a
where a vessel includes a main branch
for use with self-expanding stents. Particularly, device 400H includes outer sheath 450, self-
back outer sheath 450. In the experience of the inventor hereof, the self-expanding stent
may be different from another method using a balloon expandable stent. Typically, self-
intervention should the carina shift laterally and obstruct blood flow to the side branch 120B.
catheter 200C of . Particularly, balloon 200C may have two exit points (260 and
at the carina of a bifurcation and just before a side branch. Proximal exit point 262 (at or near
edge 272 of proximal tapered region 210) may be used to place stent 440 accurately after the
shows device 400G with a balloon catheter with three lumens —
procedure involving a trifurcation or the like (e.g.,
splitting into three side branches). In this case, each of guide wires 410, 420, 430 may
facilitate positioning a stent with respect to each of three side branches.
[00661 shows bifurcation delivery device 400H in a configuration suitable
expanding stent 440, and inner shaft 460, as well as main lumen 230 and side channel 246.
Delivery of stent 440 may be accomplished by unsheathing stent 440, for example, by pulling
should be oversized to the extent that it has to splay and closely conform to the spread of the
bifurcation. Often the stent has to be partially released a millimeter or two before the carina
and simultaneously gently advanced forward to get it to the carina and sometimes a fraction
of the strut length beyond the carina. Thus, a method of deploying a self-expanding stent
expanding stents are intended for peripheral use. A bifurcation deployment may be
considered, for example, the common Iliac bifurcation to the external and internal Iliac or the
common femoral to superficial femoral and profound femoris bifurcation. The use of a
second wire lumen 246, as described herein, may allow accurate placement of the stent at the
bifurcation while allowing for luminal placement of both of the wires in each side branch vis-
a-vis the stent in the main vessel.
(e.g., stent 440 in )
270) of distal shoulder region
220) of a balloon catheter
main wire 410) in a first lumen, channel, or cavity
side wire 420) in a second lumen,
side lumen 240) of the catheter. In other cases, however, a medical
00681
that presents the more challenging stenosis to cross. This operation is shown in as
beforehand or as the stent approaches the bifurcation depending upon the configuration of the
bifurcation stent delivery device. In some cases, a portion of side wire 420 leaving the device
second acute angle beta
into side branch 120B. also shows main wire 410 positioned inside one of the
not drawn). It will be understood that the main branch 110 and side branches 120A and 1208
10069] at the
(e.g.,
other side vessels and thus cause the insertion of device 400A to naturally stop
10067] is a flowchart of a bifurcation stent delivery technique according to
some embodiments. To further illustrate this technique, reference is also made to FIGS. 4A-
G and 6-12. At block 505, a user or operator may position a stent
with its edge at or near at or near a proximal edge (e.g., (e.g.,
(e.g., 200A). At block 510, the user may insert a first guide wire
(e.g., main lumen 230) of the
(e.g.,
(e.g.,
catheter and/or may also insert a second guide wire
channel, or cavity (e.g.,
device manufacturer or the like may perform the operations indicated in blocks 505 and 510
to provide a pre-assembled bifurcation stent delivery device as shown in FIGS. 4A-G.
At block 515, the user may place the bifurcation stent delivery device in a
patient's vessel using the first guide wire. For example, if the main guide wire is the "first
guide wire," it may be placed across the mail vessel and into one of the branches. Typically,
the first guide wire may be placed across the lesion in the main branch and the side branch
device 400A is introduced into main branch 110 toward the bifurcation into branches 120A
and 120B. The second guide wire may be placed in the second branch (e.g. 120B)
may be shaped at a first acute angle
alpha (a) designed to (at least approximately) match a
(J3) between side branches 120A and 120B, and therefore be inserted
branches (e.g., branch 1 20A) of bifurcation 100 (for ease of illustration, stenotic plaques are
as drawn in the figures are merely examples for the purpose of illustration. The stents and
methods described herein may be used with any sizes and any configuration of the main
branch 110 and side branches 120A and 120B.
Returning to block 515, the user may advance device 400A until it stops
carina of the bifurcation. This is illustrated in where device 400A positions stent
440) exactly at carina 130. In particular, shows that side wire 420 may enter the
(e.g., 120B),
at carina 130.
At block 520, the user may inflate the balloon catheter to deploy the stent
while maintaining access to the first and second branches of the bifurcation via the first and
second guide wires, respectively. shows catheter 200A after it has been inflated so
that expanded stent 440 is correctly positioned with respect to the bifurcation. shows
side branch 120B after deflation of catheter 200A. This may be achieved by advancing wire
420 into the side branch 120B simultaneously as the balloon deflates. Subsequently, the
and 420) are within the lumen of the stent.
deployed stent 440 and to cause it to more fully conform to the walls of the bifurcation
between the first and second side branches. shows balloons 1000 and 1010, which
Returning to at block 530 the user may apply a second kissing balloon
balloon procedure is illustrated in FIGS. 12A and 12B. A shows balloon 1201 with
stent 1204 are positioned within second branch 120B and then balloon 1203 is inflated to
[00731 B depicts the result of the second kissing balloon procedure with the
100701
stent 440 expanded at carina 130 and straddling it after the catheter 200A has been deflated
and removed. also shows that side guide wire 420 has been positioned deeper within
balloon catheter may be removed in a manner so that both guide wires (410 and 420) remain
in place in each respective side branch. Importantly, it should be noted that both wires (410
At block 525, the user may apply a first kissing balloon procedure to splay the
have been advanced along their respective guide wires 420 and 410 through expanded stent
440 and into the side branches. The balloons 1000 and 1010 are inflated, thereby causing
stent 440 to further expand and conform to the shape of the vessel at the bifurcation. After
inflation of balloons 1000 and 1010, stent 440 is splayed across the bifurcation at carina 130.
is a diagram illustrating stent 440 fully splayed across carina 130 as a result of the
first kissing balloon procedure after the balloons have been deflated and removed.
100721
procedure to deploy a kissing stent within each branch of the bifurcation. The second kissing
stent 1202 and balloon 1203 with stent 1204. Balloons 1201 and 1203 have been advanced
along the guide wires 410 and 420, respectively, through expanded stent 440 and into the side
branches. Balloon 1201 and first kissing stent 1202 are positioned within first branch 120A
and then balloon 1201 is inflated to expand stent 1202. Balloon 1203 and second kissing
expand stent 1204.
deploying devices 1201 and 1203 removed from the vessel. As shown in FIGS. 12A and
12B, there may be an area of overlap between or among stents 440, 1202, and 1204 during
delivered to the bifurcation. Additionally, it is also to be noted that the methods described
herein may ensure that all stent struts are opposed to the walls of the bifurcation, thus
Therefore, using the techniques outlined above, stents 1202 and 1204 may be
cases may not need to be reconfigured in any way. The stents used in the second kissing
procedure may be deployed at the same time or sequentially. The configuration shown in
may be used to deploy stents 1202 and 1204 accurately at the carina 130 and beyond.
410 and with side branch wire 420 going through lumen 241. This would be used to deploy
420 and with side branch wire 410 going through lumen 241. This would be used to deploy
After stents 1202 and 1204 have been deployed, another kissing balloon
of the vessel. This particular stent deployment technique at the carina may save on the
ability to position stents accurately at the carina.
catheters. This is the second group or type of devices referred to above. For example, a dual-
inflation and after the balloons have been withdrawn. Unlike conventional or traditional
bifurcation stenting methods, the methods described herein may ensure that the deployed
stents are positioned accurately at the carina and cover the entire bifurcation uniformly.
Depending upon the type of stent used, this may allow anti-restenosis drugs to be uniformly
minimizing or otherwise reducing the chance of stent thrombosis.
positioned at the carina 130. These stents may be the regular pre-mounted stents, and in most
For example, a first stent delivery device may enter the vessel with lumen 230 on the wire
stent 1202. A second stent delivery device may then enter the vessel with lumen 230 on wire
stent 1204.
inflation across the bifurcation (e.g. ) may be employed to complete the procedure
and cause optimal or otherwise improved expansion and opposition of the stents to the wall
amount of radiation and/or contrast usage, and it may improve patients' outcomes due to its
Alternatives to Multi-Lumen Balloon Catheters
In some situations, a pre-configured or pre-manufactured dual-lumen balloon
catheter may not be readily available to a user. However, one or more of the stent
deployment methods described herein may be used with single-lumen, conventional
guide wire stent may be constructed from a single-lumen catheter stent by adding a second
guide wire between the stent and the balloon. The stent may be removed from the balloon
the balloon.
maintain the integrity of the stent. Typically, open-cell stents cannot be properly crimped
back onto the balloon once expanded because non-linked struts tend to not fold back well. In
contrast, a closed-cell can usually be crimped back after being expanded. For example, if
Medtronic Inc.'s ENDEAVOR open-cell stents are used, the
stent may be taken off the balloon without inflating the balloon catheter. Alternatively, a
closed-cell stent such as Cordis Corporation's CYPHER ® stent may be taken off the balloon
The dual balloon and other configurations of open-celled stents as described
wire positioned between the balloon and the stent) may be constructed by the operator or
section profile may be the lowest, especially if the device is pre-built by the manufacturer,
due to the missing side lumen. However, the same configuration may require above-
average operator skill to maneuver the second wire trapped under the stent into the side
Boston Scientific Corp.'s CHOICE ® Floppy Guide Wire or the Zinger® Support
(e.g , the CYPHER® stent) may be inflated outside the body and the
and the second guide-wire positioned inside the stent. The stent may then be reinstalled on
Starting with a single-lumen catheter, a stent delivery device may be
assembled in different ways depending upon the type of stent being used (i.e., a closed-cell
stent versus an open-cell stent). For example, the operation of removing the stent from its
balloon catheter may be performed differently open-cell versus closed cell stents, so as to
® or RESOLUTE INTEGRITY ®
by first inflating the balloon and then expanding the stent.
herein may be pre-manufactured. This would ensure that the open cell stents are not damaged
by manual handling of the stents.
100791 This stent configuration (i.e., a balloon catheter, a stent, and a second guide-
may be pre-built by a manufacturer. An advantage of this configuration is that its cross-
branch. Specifically, the entire balloon-stent-second-wire device may have to be
maneuvered into the main branch and turned so that the second wire enters the second
side branch. In some cases, to alleviate these concerns, a spring-coiled tip wire (e.g.,
Guidewire by Medtronic) may be used as the second wire under the stent and the tip may
be steered into the second side branch, even though the spring coil is under the stent,
because the distal wire tip is connected to the steel core of the wire under the spring coils.
Again, in the case of the off-label use of a closed-cell stent, for example, a
traditional stent balloon
trap the secondary wire between the stent and the balloon. In
(e.g.,
(e.g., a 0.014 spring tip wire because the internal stent
stent expanded. A secondary wire
wire is attached to the tip and can rotate the tip even if the wire is under the crimped stent)
may be introduced between the balloon and the stent struts. The stent may be re-crimped to
some applications, an
approximately –3-5 mrn tip of the wire may be kept curved beyond the gent. Additionally, a
0.014 guide wire may be introduced to the main (or only) lumen to prevent damage to this
channel when re-crimping the stent. As described above, the stent may be positioned forward
onto the distal shoulder of the balloon, usually at the distal edge of the distal balloon marker
manually by the operator's fingers), and
on the shaft. The stent may be then re-crimped
a #2.0 silk or the like may be wrapped around the stent and further crimped manually. A 6F
sheath may also be cut into approximately –1.5-2.5 inches, split, and placed on the shaft of
the balloon with the second wire in it. The proximal side of this piece of the sheath may be
beveled and used to introduce the stent through the valve of a Touhy borst adapter or another
medical apparatus used for attaching catheters to other devices. The stent may be loaded on
the wire that is main branch of the bifurcation. As the stent is advanced, the secondary wire
may be manipulated so that it enters the side branch of the bifurcation. Again, the stent may
advance until it stops naturally at the carina. After the stent is deployed at the carina and the
balloon is being deflated, the side branch wire may be advanced into the side branch, and the
process may continue similarly as otherwise described herein.
In the case of the off-label use of an open-cell stent, an operator may receive
an assembled device including a balloon catheter and the open-cell stent. As before, the
balloon catheter may be a single-lumen catheter—i.e., configured to accept only one guide
wire. However, rather than inflating the balloon to expand the stent, the operator may slide
the stent off of the balloon to remove it from the assembly. The stent may be loosened off the
balloon by rocking the proximal and distal portions of the balloon shaft within the stent in
multiple directions. This expands the stent minimally to get it off the balloon. For example,
in some cases an approximately –8-9 mm stent may be used for this purpose. Then, a second
guide wire may be added between an inner surface of the stent and an outer surface of the
balloon catheter, and the stent may be slid back over the catheter, thus trapping the second
guide wire between the stent and the catheter. The distal edge of the stent in the assembled
device may be at the distal shoulder region of the balloon. The stent may be re-crimped
manually, for example, with a #2 silk thread similarly as described for the closed-cell stent
above.
either assembled at the time of the case with available materials (as described above) or
manufactured in vitro,
bifurcation delivery device following the operations described in connection with .
Particularly, open-cell stent 1305 with a crown of struts 1330 may have one or more struts
interconnected. In this case, cells 1340 are considered to be open—although, typically, one
C shows an example of a bifurcation stent delivery device
employing a single-lumen catheter, as described above. Device 1300 is similar to device
400C shown in , but without second lumen 244. In device 1300, side guide wire
1301 is crimped between stent 1302 and catheter 1303. Although stent 1302 is illustrated as
a closed-cell stent (e.g.,
13A). In situations where the device is assembled by an operator in an "off-label" procedure
(i.e.,
and into a first branch. Device 1300 may be advanced along main guide wire 1304 into the
assist in "catching" the second branch. This will stop the balloon 1303 and stent 1302
the bifurcation as described above.
PCT/1JS2012/052864
In some situations, when there is a stent with a second wire under the stent,
pre-
manufactured as described herein, an introducer device may be used to get the stent-wire
configuration across a hemostasis valve without damaging or changing the shape of the
second guide wire tip protruding from the distal edge of the stent. Such an introducer may be
for example, by cutting an appropriate length of a #6 French sheath as
described above.
A illustrates open-cell stent 1305 that may be used to assemble a
unattached to the adjacent crown of struts, thus creating a few struts 1310 that are
of every 3-6 cells may be connected to each other.
B shows closed-cell stent 1315, which may be used following the
operations described in . In contrast with open-cell stent 1305, every crown of struts
1335 of closed-cell stent 1315 is connected to the adjacent crown of struts 1335, thus creating
all closed cells 1320.
FIGURE 13
(e.g., as in B), an open-cell stent may also be used as in FIG.
as opposed to pre-built by a manufacturer), the methods depicted in FIGS. 14 and 15
may be employed. Main guide wire 1304 is positioned in the vessel across the bifurcation
vessel toward the bifurcation. Side guide wire section 1301A will be guided into the second
branch as device 1300 approaches the bifurcation. Wire section 1301A may be curved to
adjacent to the carina of the bifurcation. The stent may then be deployed and splayed across
assembly using a single-lumen catheter with a closed-cell stent
according to some embodiments. At block 1405, the user may inflate the balloon to expand
the balloon while leaving a curved portion beyond the stent. The curved portion will be
PCT/1JS2012/052864
Turning now to , a flowchart of a bifurcation stent delivery device
(e.g., in B) is depicted
the stent outside the patient's body. At block 1410, a user may position a stent at a forward
shoulder of a balloon catheter having a single lumen. Positioning the stent at the forward
shoulder of the lumen will help to deploy the stent right at the carina of the bifurcation. At
block 1415, the user may insert a secondary wire between the balloon and the stent. Then, at
block 1420, the user may re-crimp the stent to trap the secondary wire between the stent and
directed into a side branch at the bifurcation to help position the stent at the carina.
The technique shown in is particularly suitable for use with closed-
cell stents, where the stent is amenable to being expanded and re-crimped, thus returning to
its original configuration. As the inventor hereof has recognized, in the case of open-cell
stents, it may not be possible to return the stent to its original form after its initial expansion.
Nonetheless, it has been determined that, with respect to pre-assembled stent delivery devices
having an open-cell stent surrounding a balloon catheter, the open-cell stent in certain types
of stents, may be removed from the assembly without causing damage to the stent or to the
catheter without inflating the stent.
Accordingly, is a flowchart of a bifurcation stent delivery device
assembly using a single-lumen catheter with an open-cell stent according to some
embodiments. At block 1505, the user or operator may receive the pre-assembled delivery
device and may slide the open-cell stent off of the catheter to remove it from the assembly.
In some cases, this operation may require that the user apply some amount of manipulation to
loosen the stent and use some amount of gentle force to get the stent off the balloon. At
block 1510, the operator may insert a secondary guide wire between the balloon and the stent.
Then, at block 1515, the user may slide the stent back over the balloon catheter, thus trapping
the secondary guide wire between the stent and the balloon while positioning the distal edge
of the stent at the tapered edge of the balloon, typically farther forward that its original
position in the assembly.
In some cases, the pre-assembled device may be such that the edge of the
open-cell stent is positioned at the distal shoulder region of the catheter (e.g., very close to, or
exactly on the tapered edge). In many applications, such repositioning of the open-cell stent
deployed accurately at the carina of a bifurcation during balloon expansion.
embodiments. Particularly, A shows a dual balloon configuration 1600 with single
the stent may be used to help position the stent at the carina. In some implementations, a
two parallel balloon catheters 1602 and 1603. Balloons 1602 and 1603 are sized to fit into
are first placed in the vessel and each guide wire is positioned into its own side branch of the
carina and the stent then may be deployed at this location by inflating both the balloons at the
B depicts stent delivery device 1610 according to an alternative
embodiment. Specifically, stent 1611 is crimped over a parallel combination of balloon
catheter 1612 (for a first guide wire) and a long tube catheter 1613 with an approximately
maintaining dual side branch access through the stent lumen.
C depicts another embodiment of a stent delivery device. Stent 1621
sections that are longer than stent 1621. As a result, sections 1625 on each balloon 1622,
may ensure that the second guide wire, now trapped between the stent and the balloon
catheter, will cause a) the stent to stop at the carina of the bifurcation and b) the stent to be
FIGS. 16A-C are diagrams of alternative delivery devices according to some
stent 1601 crimped over two balloons 1602 and 1603. Radiopaque markers on the shaft or
commercially available stent-balloon catheter may be modified by crimping stent 1601 over
the first and second side branches of a bifurcation. Two parallel guide wires 1605 and 1606
bifurcation. Each balloon 1602, 1603 is then advanced along the guide wires 1605 and 1606
though the vessel to the bifurcation. The two balloon-stent device 1600 may stop at the
same time. In such an embodiment, the deployment and splaying of the distal portion of the
stent may occur at the same time as pre-dilatation of the stenosis in the first and second side
branches. If only open-cell stents are available on the market, this dual balloon configuration
may be pre-manufactured. The configuration may be used with the closed-cell Cypher stent,
but this stent is currently off the market and no longer available from the manufacturer.
0.014-inch wire lumen (for a second guide wire). Device 1610 may also include markers (not
shown) on the shaft of the stent itself to assist in positioning the device. The embodiment of
device 1610 with catheter 1613 may facilitate accurate delivery at the carina while
[0092T
is crimped over balloon catheters 1622 and 1623. The catheters have inflation balloon
1623 extend beyond the distal edge of stent 1621. This configuration may be useful, for
example, to dilate each side branch 120A and 120B () of the bifurcation when stent
1621 is deployed. This would prepare the side branches for a subsequent kissing stenting
operation. Additionally, the inflation of segments 1625 in different side branches would
cause stent 1621 to be splayed across the bifurcation with the first inflation itself. This
embodiment may make it easier to splay stent 1621 in order to achieve the configuration
depicted in of and , for example.
A illustrates a three-stent delivery device 1700 according to another
alternative embodiment. A stent 1704 is positioned on balloon 1702 and stent 1705 is
positioned on balloon 1703. Thereafter stent 1701 is positioned around both the balloon
catheters 1702 and 1703, with the distal end of the stent overlapping the stents 1704 and
1705. This configuration allows for the simultaneous deployment of stent 1701 in the main
vessel before a bifurcation and deployment of stents 1704 and 1705 in separate side branches.
B illustrates device 1700 deployed at a bifurcation. First, guide wires
1706, 1707 are positioned though main vessel 110 and into separate side branches 120A,
120B. Then, device 1700 is advanced along the guide wires with balloon catheter 1702
traveling along guide wire 1706 and balloon catheter 1703 traveling along guide wire 1707.
As device 1700 approaches the bifurcation, the balloons are directed into separate side
branches. The device will stop moving into the vessel when the balloon segments covered by
stents 1704 and 1705 have entered the side branches. Stent 1701 cannot move into the side
branches, but will be stopped at carina 130. Once the device 1700 is positioned with stent
1701 at the carina in this manner, the balloons 1702, 1703 may be inflated as illustrated in
B. This inflation will simultaneously deploy stent 1701 in the main vessel proximal
to carina 130 and stents 1704, 1705 in the side branches distal to carina 130. Additionally,
device 1700 performs the kissing balloon techniques when it is inflated, which splays stent
1701 across the bifurcation.
As a person of ordinary skill in the art will recognize in light of this disclosure,
one or more of the numerous embodiments described herein may provide one or more
advantages over known stent deployment techniques. For example, some of these
embodiments may prevent guide wires from becoming tangled. In some cases, access to a
side branch may be maintained using the second guide wire when deploying a stent in the
main vessel. Furthermore, the wire going into the side branches may be maintained within
the lumen of the stent, rather than through the stent struts. One or more of the techniques
disclosed herein may also guarantee the exact location of the stent at the carina, which makes
treatment.
main stent exactly at the carina. Because in embodiments where the bare wire is trapped
under the stent the side guide wire is generally unable to move within the lumen, a 'V' shape
may be created between the guide wire and the balloon catheter of the main branch stent. As
the device advances with the side wire in the side branch and the main wire in the main
of the carina in two dimensions because of variable side branch vessel overlap. Hence the
particular suitability of certain of these techniques and innovations to accurately place stents
In some cases, the stent delivery systems and methods described herein may
open—that is, stent struts do not protrude into the lumen and a true pantaloons configuration
may be obtained. This method of stenting may therefore eliminate or otherwise reduce the
risk of stent thrombosis due to stent struts that are not opposed to the wall of the vessel.
it less likely that areas of the bifurcation lesion will remain uncovered by stents after
Moreover, in contrast with existing devices currently used to treat bifurcation
lesions, one or more of the devices disclosed herein may be manufactured with a low or small
profile, may be easy to maneuver, and may therefore be particularly well suited for the
treatment of coronary arteries, which are typically small in diameter (although it may also be
used in any bifurcation lesion). In some devices, the side lumen may ensure access to the
side branch of the bifurcation. Further, in some cases, the side guide wire may help place the
branch, it may stop at the vertex of bifurcation. As such, one or more of the techniques
described herein may guarantee precise placement of a stent at the carina with any amount of
plaque buildup in the arteries, and while ensuring there is full coverage of the bifurcation.
Under fluoroscopy in two dimensions, it is often very difficult to identify the precise location
at bifurcations in coronary, peripheral vascular, venous or other anatomical locations.
provide a 100% or near 100% apposition or coverage of the bifurcation lesion by the stent
struts, thereby eliminating a limitation of present day stenting of such lesions. In a typical
scenario, 100% coverage of the lesion may be a particularly critical issue with local lesion
drug delivery by drug eluting stents to prevent restenosis. In addition, 100% or near 100%
stent apposition to the bifurcation lesion ensures that luminal access to each branch is wide
Furthermore, in the case of restenosis or new lesions developing downstream to the
bifurcation, normal anatomical access allows subsequent operators to cross through the
bifurcation with wires, balloons and stents without any metallic luminal obstacles caused by
struts not in apposition to the walls of the bifurcation.
In some cases, the stent delivery systems and methods described herein may
also prevent the carina of the bifurcation from being shifted from its anatomical location.
pressures. The stent in the main vessel may be accurately delivered at the carina by making
sure that the distal end of the stent is positioned forward on the shoulder or distal taper of the
deploying balloon than is the case with more conventional stents. In addition, problems of
plaque shifting are also eliminated or otherwise reduced. In various implementations, the
two wires in each lumen may always be within the lumen of the stents and do not at any time
certain of the stent delivery techniques described herein, for instance, through an 8F (crossing
profile of the guiding catheter) system. For example, the closed-cell design of the CYPHER ®
stent is particularly suitable for this method because it can be re-crimped after expanding it
®, or
the RESOLUTE INTEGRITY®
expanding the stent. Also conventional stents, wires, and materials may be used to
off-FDA label utilization of these
stents). While such an off-label technique may require a higher level of operator expertise for
reconfiguration of the stent for the bifurcation, after the initial learning curve is overcome,
such a method is also very feasible.
stenting. Additional innovations described herein may be used to accurately deliver a stent at
lesion situations where stenting is required in the main vessel but the stent needs to be
carina is shifted,
This may be guaranteed by deflating the kissing balloons together at the same inflation
go through stent struts.
Certain conventional balloon and stent profiles are small enough to utilize
outside the patient's body. Other open cell stents such as, for example, the ENDEAVOR
may be loosened and removed from the balloon without
reconfigure a stent for delivery at the bifurcation (i.e.,
With one or more of the innovations described herein, stent delivery systems can
be created to make the delivery operator friendly and achieve routine use for bifurcation
a trifurcation, for example, a left-main trifurcation into the left anterior descending, ramus
intermedius and circumflex arteries. Yet additional innovations may accurately deliver stents
beyond the carina without jailing a side branch. This may be utilized in other non-bifurcation
delivered without jailing a side branch, while maintaining access to the branch in case the
As such, in various embodiments, the stent delivery systems and methods
described herein may be particularly useful for use with patients who cannot undergo bypass
surgery safely. Moreover, one or more of these techniques may be safely used in patients
PCT/US20121052864
with "complex" bifurcation lesions, thus making complex bifurcation operations a matter of
may be changed, and various elements of the systems or devices illustrated herein may be
added, reordered, combined, omitted, modified, etc. Various modifications and changes may
modifications and changes and, accordingly, the above description should be regarded in an
illustrative rather than a restrictive sense.
routine; thus helping decrease the need for such surgery.
[0M] The various systems and methods illustrated in the figures and described herein
represent example embodiments of systems and methods for deploying stents within
bifurcated blood vessels. The order in which each operation of a given method is performed
be made as would be clear to a person of ordinary skill in the art having the benefit of this
specification. It is intended that the invention(s) described herein embrace all such
Claims (3)
1. A device, comprising: a first balloon catheter; a first stent positioned around the first balloon catheter; a second balloon catheter; a second stent positioned around the second balloon catheter; a first lumen in the first balloon catheter and configured to house a first guide wire; a second lumen in the second balloon catheter and configured to house a second guide wire; and a third stent positioned around both the first and second balloon catheter, wherein the first, second and third stents are separate components, and wherein the third stent partially overlaps the first stent and the second stent.
2. The device of claim 1, wherein the first lumen is positioned along an axis of the first balloon catheter.
3. The device of claim 1 or 2, wherein the second lumen is positioned along an axis of the second balloon catheter.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161528968P | 2011-08-30 | 2011-08-30 | |
US61/528,968 | 2011-08-30 | ||
US13/473,892 US8574283B1 (en) | 2011-08-30 | 2012-05-17 | Deployment of stents within bifurcated vessels |
US13/473,892 | 2012-05-17 | ||
NZ622552A NZ622552A (en) | 2011-08-30 | 2012-08-29 | Deployment of stents within bifurcated vessels |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ721317A NZ721317A (en) | 2018-02-23 |
NZ721317B2 true NZ721317B2 (en) | 2018-05-24 |
Family
ID=
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