U.S. patent application number 11/685339 was filed with the patent office on 2007-07-05 for apparatus and methods for delivery of multiple distributed stents.
This patent application is currently assigned to XTENT, INC.. Invention is credited to Bernard Andreas, SUNMI CHEW, Mark E. Deem, Ron French, Hanson S. III Gifford, Allan Will.
Application Number | 20070156226 11/685339 |
Document ID | / |
Family ID | 29255288 |
Filed Date | 2007-07-05 |
United States Patent
Application |
20070156226 |
Kind Code |
A1 |
CHEW; SUNMI ; et
al. |
July 5, 2007 |
APPARATUS AND METHODS FOR DELIVERY OF MULTIPLE DISTRIBUTED
STENTS
Abstract
Blood vessels and other body lumens are stented using multiple,
discreet stent structures. Stent structures may be balloon
expandable or self-expanding and are delivered by a delivery
catheter which is repositioned to spaced-apart delivery sights. By
coating the stents with particular biologically active substances,
hyperplasia within and between the implanted stents can be
inhibited. An exemplary delivery catheter comprises a catheter body
having both a pusher rod for advancing the stents relative to a
sheath and a reciprocatable delivery catheter for implanting the
stents.
Inventors: |
CHEW; SUNMI; (San Jose,
CA) ; Andreas; Bernard; (Redwood City, CA) ;
Gifford; Hanson S. III; (Woodside, CA) ; French;
Ron; (Santa Clara, CA) ; Deem; Mark E.;
(Mountain View, CA) ; Will; Allan; (Atherton,
CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP;(CLIENT NO 021629-000000)
TWO EMBARCADERO CENTER
8TH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
XTENT, INC.
Menlo Park
CA
|
Family ID: |
29255288 |
Appl. No.: |
11/685339 |
Filed: |
March 13, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10306813 |
Nov 27, 2002 |
|
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11685339 |
Mar 13, 2007 |
|
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60336967 |
Dec 3, 2001 |
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60364389 |
Mar 13, 2002 |
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Current U.S.
Class: |
623/1.12 ;
623/1.11; 623/1.16 |
Current CPC
Class: |
A61F 2002/91541
20130101; A61F 2/95 20130101; A61F 2/915 20130101; A61F 2002/91558
20130101; A61F 2210/0033 20130101; A61F 2002/826 20130101; A61F
2/0095 20130101; A61F 2/966 20130101; A61F 2002/91591 20130101;
A61F 2002/9583 20130101; A61F 2002/91533 20130101; A61F 2210/0042
20130101; A61F 2002/828 20130101; A61F 2002/9155 20130101; A61F
2/91 20130101; A61F 2250/0071 20130101; A61F 2/958 20130101 |
Class at
Publication: |
623/001.12 ;
623/001.11; 623/001.16 |
International
Class: |
A61F 2/84 20060101
A61F002/84 |
Claims
1. A method for stenting extended lengths of a body lumen, said
method comprising: introducing a catheter carrying a plurality of
radially expansible prostheses to a stenotic lesion within said
body lumen, wherein said prostheses are arranged end-to-end and
covered by a sheath; retracting the sheath by a first distance to
uncover a first multiplicity of the prostheses, wherein the
uncovered prostheses do not expand during retraction; and radially
expanding each of said first multiplicity of uncovered prostheses
simultaneously at a first location within said stenotic lesion
while at least one other prosthesis is retained on the catheter,
said first multiplicity of prostheses engaging a wall of the body
lumen with sufficient radial force to maintain patency thereof,
said prostheses being spaced apart from each other after expansion
by a distance small enough to inhibit hyperplasia therebetween.
2. A method as in claim 1, further comprising inflating a balloon
within said prostheses to effect expansion.
3. A method as in claim 2, wherein inflating comprises inflating a
balloon disposed both under said prostheses to be expanded and
under at least some prostheses which remain under the sheath,
wherein inflation of the balloon under the sheath is constrained by
the sheath to prevent expansion of the at least some
prostheses.
4. A method as in claim 2, further comprising engaging a proximal
end of the plurality of prostheses with a pusher tube to axially
restrain the prostheses as the sheath is retracted.
5. A method as in claim 4, further comprising engaging one of the
prostheses with a valve member coupled with the distal end of the
sheath.
6. A method as in claim 5, further including retracting the sheath
and the pusher tube to separate prostheses proximal to the valve
member from the first multiplicity of prostheses.
7. A method as in claim 6, wherein separating comprises inflating a
balloon disposed under said first multiplicity of prostheses.
8. A method as in claim 1, further comprising heating the uncovered
prostheses to effect expansion.
9. A method as in claim 8, wherein heating comprises directing a
heated medium through the catheter to the uncovered prostheses.
10. A method as in claim 8, wherein heating comprises energizing a
heating element positioned adjacent to the uncovered
prostheses.
11. A method as in claim 8, further comprising engaging a proximal
end of the plurality of prostheses with a pusher tube to axially
restrain the prostheses as the sheath is retracted.
12. A method as in claim 1, wherein said prostheses are resilient
and radially constrained within the sheath, wherein the prostheses
radially expand as the sheath is retracted.
13. A method as in claim 12, further comprising engaging a proximal
end of the plurality of prostheses with a pusher tube to axially
restrain the prostheses as the sheath is retracted.
14. A method as in claim 1, further comprising repositioning the
catheter and further retracting the sheath by a second distance to
uncover a second multiplicity of prostheses, said second
multiplicity of uncovered prostheses radially expanding at a second
location within said target site.
15. A method as in claim 1, wherein the body lumen is a blood
vessel.
16. A method as in claim 1, wherein the prostheses have at least
one agent disposed thereon.
17. A method as in claim 16, wherein the agent inhibits
hyperplasia.
18. A method as in claim 17, wherein the agent is biologically
active.
19. A method as in claim 18, wherein the biologically active agent
is selected from the group consisting of anti-neoplastic drugs such
as paclitaxel, methotrexate, and batimastal; antibiotics such as
doxycycline, tetracycline, rapamycin, and actinomycin;
immunosuppressants such as dexamethasone and methyl prednisolone;
nitric oxide sources such as nitroprussides; estrogen; and
estradiols.
20. A method as in claim 17, wherein the agent is biologically
inert.
21. A method as in claim 20, wherein the biologically inert agent
is selected from the group consisting of collagen, polyethylene
glycol (PEG), polyglycolic acids (PGA), ceramic material, platinum
and gold.
22. A method for stenting extended lengths of a body lumen, said
method comprising: introducing a catheter carrying at least three
discrete stents; releasing at least a first stent from the catheter
at a first location in the body lumen; repositioning the catheter;
releasing at least a second stent from the catheter at a second
location, wherein at least a third stent from the catheter is
released and radially expanded simultaneously with one of said
first or second stent, the third stent being spaced apart from the
first or second stent after release by a distance which is small
enough to inhibit hyperplasia therebetween said first, second, and
third stents engaging a wall of the body lumen with sufficient
radial force to maintain patency thereof.
23. A method as in claim 22, wherein the catheter carries at least
four discrete stents, further comprising repositioning the catheter
and releasing at least a fourth stent at a fourth location.
24. A method as in claim 23, wherein the catheter carries at least
five discrete stents, further comprising repositioning the catheter
and releasing at least a fifth stent at a fifth location.
25. A method as in claim 22, wherein the body lumen comprises a
blood vessel.
26. A method as in claim 25, wherein the stents are released at
locations which span a length of at least 3 mm in the blood
vessel.
27. A method as in claim 25, where at least two stents are
positioned on opposite sides of an opening in the blood vessel to a
side branch.
28. A method as in claim 22, wherein releasing the stents comprises
expanding a balloon within the stents.
29. A method as in claim 22, wherein releasing the stents comprises
releasing the stents from constraint and allowing the stents to
self-expand.
30. A method as in claim 22, wherein the stents have at least one
agent disposed thereon.
31. A method as in claim 30, wherein the agent inhibits
hyperplasia.
32. A method as in claim 30, wherein the agent is biologically
active.
33. A method as in claim 32, wherein the biologically active agent
is selected from the group consisting of anti-neoplastic drugs such
as paclitaxel, methotrexate, and batimastal; antibiotics such as
doxycycline, tetracycline, rapamycin, and actinomycin;
immunosuppressants such as dexamethasone and methyl prednisolone;
nitric oxide sources such as nitroprussides; estrogen; and
estradiols.
34. A method as in claim 30, wherein the agent is biologically
inert.
35. A method as in claim 34, the biologically inert agent is
selected from the group consisting of collagen, PEG, PGA, ceramic
material, platinum and gold.
36. A method as in claim 16, wherein the agent is disposed in a
bioresorbable material formed on or within the prostheses.
37. A method as in claim 36, wherein the bioresorbable material is
selected from the group consisting of polyethylene glycol,
collagen, gelatin, polyglocolic acids, and polylactic acids.
38. A method as in claim 30, wherein the agent is disposed in a
bioresorbable material formed on or within the prostheses.
39. A method as in claim 38, wherein the bioresorbable material is
selected from the group consisting of polyethylene glycol,
collagen, gelatin, polyglycolic acids, and polylactic acids.
40. The method of claim 1, wherein the distance between adjacent
prostheses after expansion in the body lumen is no more than about
1 mm.
41. The method of claim 22, wherein the distance between the third
stent and the first or second stent after expansion is no more than
about 1 mm.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application is a divisional of U.S. patent
application Ser. No. 10/306,813 (Attorney Docket No.
021629-000320US), filed Nov. 27, 2002, which was a non-provisional
of U.S. patent application Ser. No. 60/336,967 (Attorney Docket No.
021629-000300) filed Dec. 3, 2001, and is also a non-provisional of
U.S. patent application Ser. No. 60/364,389 (Attorney Docket No.
021629-000310) filed on Mar. 13, 2002, the full disclosures of
which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to medical devices
and methods. More particularly, the present invention relates to
apparatus and methods for independently delivering a plurality of
luminal prostheses within a body lumen, such as a blood vessel.
[0004] Coronary artery disease is the leading cause of death and
morbidity in the United States and Western society. In particular,
atherosclerosis in the coronary arteries can cause myocardial
infarction, commonly referred to as a heart attack, which can be
immediately fatal or, even if survived, can cause damage to the
heart which can incapacitate the patient.
[0005] While coronary artery bypass surgery can be an effective
treatment for stenosed arteries resulting from atherosclerosis or
other causes, it is a highly invasive, costly procedure, which
typically requires substantial hospital and recovery time.
Percutaneous transluminal coronary angioplasty, commonly referred
to as balloon angioplasty, is less invasive, less traumatic, and
significantly less expensive than bypass surgery. Heretofore,
however, balloon angioplasty has not been considered as effective a
treatment as bypass surgery. The effectiveness of balloon
angioplasty, however, has improved significantly with the
introduction of stenting which involves the placement of a scaffold
structure within the artery which has been treated by balloon
angioplasty. The stent inhibits abrupt reclosure of the artery and
has some benefit in inhibiting subsequent restenosis resulting from
hyperplasia. Recently, experimental trials have demonstrated that
the coating of stents using anti-proliferative drugs, such as
paclitaxel, can significantly reduce the occurrence of hyperplasia
in angioplasty treated coronary arteries which have been stented
with the coated stents.
[0006] While the combination of balloon angioplasty with
drug-coated stents holds great promise, significant challenges
still remain. Of particular interest to the present invention, the
treatment of extended or disseminated disease within an artery
remains problematic. Most stents have a fixed length, typically in
the range from 10 mm to 30 mm, and the placement of multiple stents
to treat disease over a longer length requires the suggestive use
of balloon stent delivery catheters. Moreover, it can be difficult
to stent an angioplasty-treated region of a blood vessel with the
optimum stent length.
[0007] For these reasons, it would be desirable to provide improved
stents, stent delivery systems, stenting methods, and the like, for
the treatment of patients having coronary artery disease, as well
as other occlusive diseases of the vasculature. In particular, it
would be desirable to provide stents, delivery systems, and methods
for the treatment of disseminated and variable length stenotic
regions within the vasculature. For example, it would be desirable
to provide a practical method which permits a physician to optimize
the length of the treated vessel which is stented according to the
nature of the disease. More specifically, it would be desirable to
provide apparatus, systems, and methods for facilitating the
delivery of multiple stents and other prostheses to blood vessels
or other target body lumens. Such apparatus, systems, and methods
should be suitable for delivery of individual stents or prostheses
having very short lengths, typically as short as 3 mm or shorter,
at multiple contiguous and non-contiguous locations within a body
lumen for optimized treatment thereof. At least some of these
objectives will be met by the inventions described hereinafter.
[0008] 2. Description of the Background Art
[0009] U.S. Pat. No. 6,258,117 B1 describes a stent having multiple
sections connected by separable or frangible connecting regions.
Optionally, the connecting regions are severed after the stent
structure has been implanted in the blood vessel. U.S. Pat. Nos.
5,571,086; 5,776,141; and 6,143,016 describe an expandable sleeve
for placement over a balloon catheter for the delivery of one or
two stent structures to the vasculature. U.S. Pat. No. 5,697,948
describes a catheter for delivering stents covered by a sheath.
BRIEF SUMMARY OF THE INVENTION
[0010] The present invention provides methods and apparatus for
prosthesis placement, such as stenting of body lumens, typically
blood vessels, and more typically coronary arteries. The methods
and systems will also find significant use in the peripheral
vasculature, the cerebral vasculature, and in other ducts, such as
the biliary duct, the fallopian tubes, and the like. The terms
"stent" and "stenting" are defined to include any of the wide
variety of expandable prostheses and scaffolds which are designed
to be intraluminally introduced to a treatment site and expanded in
situ to apply a radially outward force against the inner wall of
the body lumen at that site. Stents and prostheses commonly
comprise an open lattice structure, typically formed from a
malleable or elastic metal. When formed from a malleable metal, the
stents will typically be expanded by a balloon which causes plastic
deformation of the lattice so that it remains opened after
deployment. When formed from an elastic metal, including super
elastic metals such as nickel-titanium alloys, the lattice
structures will usually be radially constrained when delivered and
deployed by releasing the structures from such radial constraint so
that they "self-expand" at the target site. When the stent or
lattice structures are covered with a fabric or polymeric membrane
covering, they are commonly referred to as grafts. Grafts may be
used for the treatment of aneurysms or other conditions which
require placement of a non-permeable or semi-permeable barrier at
the treatment site. The terms "prosthesis" and "prostheses" refer
broadly to all radially expansible stents, grafts, and other
scaffold-like structures which are intended for deployment within
body lumens.
[0011] The stents and prostheses of the present invention may have
any of a variety of common constructions, including helical
structures, counterwound helical structures, expandable diamond
structures, serpentine structures, or the like. Such conventional
stent structures are well described in the patent and medical
literature. Specific examples of suitable stent structures are
described in the following U.S. patents, the full disclosures of
which are incorporated herein by reference: U.S. Pat. Nos.:
6,315,794; 5,980,552; 5,836,964; 5,527,354; 5,421,955; 4,886,062;
and 4,776,337, the full disclosures of which are incorporated
herein by reference. Preferred structures are described herein with
reference to FIGS. 4 and 5.
[0012] According to the present invention, the stents which are
deployed may have a length of 1 mm or greater, usually 2 mm or
greater, and typically of 3 mm or greater, usually being in the
range from 1 mm to 100 mm, typically from 2 mm to 50 mm, more
typically from 2 mm to 25 mm, and usually from 3 mm to 20 mm. The
use of such short stent lengths is advantageous since multiple
stents are to be employed.
[0013] The methods and apparatus of the present invention will
provide for the deployment of a plurality of stents or other
prostheses, usually including at least two stents, from a common
stent delivery catheter. Usually, the number of delivered stents
will be in the range from 2 to 50, typically from 3 to 30, and most
typically from 5 to 25. As more stents are placed on the delivery
catheter, the individual stent length will often be somewhat less,
although this is not necessarily the case in all instances. The
multiple prostheses may be deployed individually or in groups of
two or more at single or multiple spaced-apart locations in the
body lumen or lumens.
[0014] In a first aspect of the present invention, a method for
stenting an extended length of a body lumen comprises introducing a
catheter carrying a plurality of, usually at least two, discrete
stents to the body lumen. Usually, the introduction is percutaneous
and, in the case of intravascular delivery, uses a conventional
introduction technique, such as the Seldinger technique. After
reaching a target location, at least a first stent is released from
the catheter at that first location. The catheter is then
repositioned to a second location, and at least a second stent is
released from the catheter at the second location. The catheter is
then repositioned to a third location, and at least a third stent
is released from the catheter at the third location
[0015] In addition to deploying stents and other prostheses at
spaced-apart locations within a blood vessel or other body lumen,
the methods and apparatus in the present invention can be used for
delivering one, two, three, or more discrete stents or other
prosthetic segments contiguously at a single location within the
body lumen. In this way, the length of the prosthesis which is
implanted can be selected and modified to accommodate the length of
the vessel to be treated. It will be appreciated that with systems
which carry 10, 20, 30 or more quite short prostheses or prosthesis
segments, the length of the lumen being treated can be tailored
very closely from very short to very long with the selectable
intervals depending on the length of the prosthesis or prosthesis
segment.
[0016] The deployment steps can, of course, be repeated a
sufficient number of times so that all or at least most of the
stents carried by the delivery catheter are delivered to and
deployed within the body lumen. A particular advantage of this
delivery method is that the discrete stents may be distributed
along extended lengths of the body lumen, typically in the range
from 1 cm to 2 cm, often in the range from 1 cm to 5 cm, and in
many instances even longer. Additionally, the stents may be
delivered so as to avoid side branches or other regions where
placement of the stent is undesirable. Moreover, with the use of
drug-coated stents, it may be possible to place the stents apart by
discrete distances, typically from one-half to one millimeter (mm),
while still achieving vessel patency and hyperplasia
inhibition.
[0017] Releasing of the stents from the catheter may be achieved
using a balloon to cause balloon expansion of the stent.
Alternatively, release of the stent may be achieved by radially
constraining an elastic or self-expanding stent within a lumen of
the delivery catheter and selectively advancing the stent from the
catheter and/or retracting the catheter from over the stent. In one
embodiment, a sheath over the stents includes a valve member, or
"stent valve," which allows stents to be separated so that a
balloon can more accurately inflate deployed stents while other
stents remain within the sheath.
[0018] In preferred embodiments, the stents are coated with at
least one agent, such as an agent which inhibits hyperplasia. The
agent may be biologically active or inert. Particular biologically
active agents include anti-neoplastic drugs such as paclitaxel,
methotrexate, and batimastal; antibiotics such as doxycycline,
tetracycline, rapamycin, and actinomycin; immunosuppressant such as
dexamethosone, methyl prednisolone, nitric oxide sources such as
nitroprussides; estrogen; estradiols; and the like. Biologically
inert agents include polyethylene glycol (PEG), collagen,
polyglycolic acids (PGA), ceramic material, titanium, gold and the
like.
[0019] In another aspect, the present invention comprises catheters
and apparatus for stenting extended lengths of a body lumen,
particularly a blood vessel. The catheters comprise a catheter body
having a proximal end and a distal end. At least two discrete
stents are carried at or near a distal end of the catheter body. By
"discrete," it is meant that the stents are unconnected and can be
deployed from the catheter in an unattached manner. (The delivery
of attached prostheses is described below.) Deployment of such
discrete stents permits the individual stents to be placed at
spaced-apart target locations or immediately adjacently within the
blood vessel or other body lumen. The catheters further comprise
deployment means for deploying the individual stents from the
catheter body. For example, the deployment means may comprise one
or more balloons for placement and radial expansion of the stents.
Alternatively, the deployment means may comprise a pusher or other
device for advancing self-expanding stents from the distal end of
the catheter body and/or a sheath for selectively retracting over
the stents to permit self-expansion. In exemplary embodiments, the
catheters will carry at least two discrete stents, at least five
discrete stents, and as many as 30 discrete stents, or in some
cases, as many as 30 or more discrete stents.
[0020] In a particular embodiment, the catheter comprises a single
balloon which is reciprocatively mounted within the catheter body
and adapted for receiving individual stents thereover. A pusher or
other device for successively and controllably loading individual
or multiple stents over the balloon is also provided. In this way,
the catheter may carry multiple stents and employ the single
balloon for positioning and expansion of the stents.
[0021] In further embodiments, the stents of the present invention
are composed at least partly of a bioabsorbable material, such as
polyethylene glycol (PEG), collagen, gelatin, polyglycolic acids
(PGA), polylactic acids (PLA), and the like. Optionally, one or
more bioactive substances are dispersed in the bioabsorbable
material such that the bioactive substance will be released over
time as the bioabsorbable material degrades. In a particular
embodiment, the bioabsorbable material is formed on or within a
scaffold composed on a non-bioabsorbable material, typically
stainless steel, Nitinol.TM., or other conventional stent metal
material. Other materials, such as gold (e.g., pure or nearly pure
gold), platinum, or the like, may also be used.
[0022] In a further aspect of the present invention, a catheter for
delivering a plurality of expansible prostheses to a body lumen
comprises a catheter body, a sheath, and a plurality of radially
expansible prostheses. The catheter body has a proximal end and a
distal end, and the sheath is coaxially disposed over the catheter
body with the prostheses positionable in an annular space between
the inside of the sheath and the exterior of the catheter body. The
sheath is preferably retractable relative to the catheter body so
that the prostheses may be advanced beyond a distal end of the
sheath. Usually, the catheter will further comprise a pusher tube
disposed coaxially over the catheter body and within an interior
lumen of the sheath. A distal end of the pusher tube will engage a
proximal end of the proximal-most prosthesis so that the pusher
tube can be distally advanced relative to the sheath to selectively
push or deploy individual prostheses from the sheath. Often, such
deployment is achieved by holding the pusher tube and prostheses
substantially stationary relative to the body lumen while the
sheath is retracted proximally to release or deploy the prostheses.
Each of the pusher tube, sheath and catheter body may have a
lubricious inner surface and/or a lubricious outer surface.
[0023] Usually, at least a distal portion of the sheath will have a
greater column strength than that of a distal portion of the
catheter body. Additionally or alternatively, the pusher tube may
also have a greater column strength than a distal portion of a
catheter body. By providing column strength in the outer most
portion of the catheter, i.e., the sheath, and optionally the
pusher tube, the overall column strength of the catheter can be
increased with a minimum increase in its diameter or profile. It
will be appreciated that low profile catheters are highly
advantageous for accessing remote regions of the vasculature,
particularly the small coronary and cerebral arteries. Using the
preferred constructions of the present invention, catheters having
diameters 2 mm or less, and in some instances as low as 1 mm or
less, can be achieved. The constructions will, of course, also be
suitable for larger diameter catheters for use in the peripheral
and other larger blood vessels.
[0024] The catheter of the present invention will preferably carry
at least two prostheses, more preferably carrying at least three
prostheses, and often carrying a greater number of prostheses as
set forth above in connection with other embodiments. The
prostheses will typically be arranged in an end-to-end manner
either with or without a physical linkage therebetween. The
physical linkage may comprise a frangible component which must be
mechanically broken or alternatively may comprise a pair of
coupling elements which fit together and which may be separated
without any material breakage. Frangible coupling elements will
usually comprise a strut, bar, spring, or similar connecting link
and will optionally be scored, notched, or otherwise adapted to
break along a particular line when a suitable mechanical force is
applied. Exemplary separable coupling elements include male and
female elements, such as a rod and tube which may be axially
separated, a tab and receptacle which may be radially separated,
and the like.
[0025] In a specific embodiment of the catheter, the catheter body
may comprise an expansion element, such as an inflatable balloon,
near its distal end. The expansion element will be positionable
distal to the retractable sheath so that it can be used to
regularly expand one or more of the prostheses. For example, the
inflatable balloon may have a lubricious outer surface and carry
multiple prostheses on its outer surface so that sheath retraction
can expose one, two, three, or more of the prostheses. The
remaining prostheses will continue to be covered by the sheath.
When inflating the balloon, however, only that portion of the
balloon and those prostheses carried on the exposed portion of the
balloon will be inflated. The remaining (proximal) portion of the
balloon will continue to be constrained by the sheath so that
neither the balloon nor the prostheses covered by the sheath will
be expanded. In this way, any preselected number of the individual
prostheses may be expanded at one time, while the remaining
prostheses are protected and unexpanded, remaining available for
subsequent expansion using the balloon.
[0026] Alternatively or in addition to the balloon, the catheter
body may comprise a heater for selectively heating prostheses which
have been advanced distally beyond the sheath. For example, the
catheter body may have a lumen for delivering a heated medium, such
as heated saline, intravascularly to heat and expand stents or
other prostheses formed from suitable heat memory alloys (as
described in more detail below). Alternatively, a separate exterior
guide catheter or other tube may be used for delivering such a
heated medium to effect expansion of the prostheses. As a third
alternative, a powered heating element, such as a radio frequency
heater, electrical resistance heater, or laser-heated element, may
be provided on the catheter body for directly heating the exposed
prostheses.
[0027] For the delivery of individual prostheses or stents which
are joined by frangible or breakable links, as discussed above, it
will often be desirable to provide a shearing mechanism on the
catheter. The shearing mechanism will usually be mechanical, but
could also be electrolytic, ultrasonic, or chemical. In the
exemplary embodiments, the shearing mechanism comprises a first
shearing element on a distal region of the catheter body and a
second or mating shearing element on a distal region of the sheath.
The prostheses may be advanced from the sheath while the shearing
mechanism on the catheter body is distally advanced (leaving a
space or opening for prosthesis deployment). After a desired number
of prostheses have been deployed, the catheter body may be
retracted relative to the sheath in order to close the shearing
elements to sever the link(s) between the advanced prostheses and
those prostheses which remain within the sheath. In other cases,
the shearing mechanism could be an electrode for inducing
electrolytic breakage of the link, an ultrasonic transducer for
mechanically degrading a susceptible link (i.e. a link having a
resonant frequency which corresponds to the ultrasonic transducer),
a luminal port for releasing a chemical agent selected to
chemically degrade the link, or the like.
[0028] In a further alternative embodiment, a catheter constructed
in accordance with the principles of the present invention
comprises a pusher tube, a plurality of radially expansible
prostheses arranged end-to-end and extending distally of the distal
end of the pusher tube, and a sheath disposed coaxially over the
pusher tube and the prostheses. Optionally, but not necessarily,
this embodiment will include a catheter body disposed coaxially
within the pusher tube and prostheses. By retracting the sheath
proximally relative to the pusher tube, individual ones or groups
of the prostheses will be exposed and deployed. The catheter body
may be used in any of the ways described previously in order to
effect or control deployment of the prostheses. Optionally, the
pusher tube, the sheath, or both, may have a greater column
strength than the catheter body when the catheter body is
employed.
[0029] Systems of detachable expansible prostheses according to the
present invention include a plurality of ring-like radially
expansible prostheses arranged end-to-end along an elongate axis.
At least one pair of coupling elements join each pair of adjacent
prostheses, where the coupling elements physically separate without
fracture in response to axial tension or differential radial
expansion. The coupling elements, however, remain coupled when
subjected to axial compression such as may occur as the prostheses
are axially advanced within a body lumen or elsewhere. The
prostheses may be composed of a malleable material so that they
will be expansible in response to an internally applied radially
expansive force, such as a balloon expansion force applied by a
balloon carried by the catheter body in any of the prior
embodiments of the present invention. Alternatively, the prostheses
may be composed of a resilient material, such as spring stainless
steel, nickel-titanium alloy; or the like, so that they may be
"self-expanding," i.e. expand when released from radial constraint.
As a third alternative, the prostheses may be composed of a heat
memory alloy, such as a nickel titanium alloy, so that they may be
induced to expand upon exposure to a temperature above body
temperature. Materials suitable for forming each of these three
types of prostheses are well described in the patent and medical
literature.
[0030] In specific examples of the systems, the coupling elements
may be male and female so that they decouple upon the application
of an axial force. For example, the coupling elements may be a rod
and a tube having a central passageway for receiving the rod.
Alternatively, the coupling elements may be configured to decouple
upon differential radial expansion. For example, a first coupling
element may extend from the end of a first prostheses and have an
enlarged portion or end. By providing a cut-out in the adjacent
prostheses having a periphery which matches the periphery of the
extension on the first prostheses, coupling elements can be mated
and locked together. The locking will resist axial separation, but
permit radial separation when one of the prostheses is radially
expanded.
[0031] The systems of prostheses just described may be preferably
employed with any of the catheter delivery systems described
previously.
[0032] The present invention further provides methods for stenting
extended lengths of the body lumen, where the methods comprise
introducing a catheter carrying a plurality of radially expansible
prostheses to a target site within the body lumen. The prostheses
are arranged end-to-end and are covered by a sheath. The prostheses
are then deployed by retracting the sheath relative to the
prostheses by a first preselected distance to uncover a first
predetermined number of the prostheses. After retraction of the
sheath, a first predetermined number of prostheses, which may be
anywhere from one up to the entire number of prostheses being
carried, are radially expanded at the target site within the target
site of the body lumen.
[0033] Prosthesis expansion may be achieved in a variety of ways.
In a first instance, the prostheses are expanded by inflating a
balloon within the particular prosthesis to be expanded. For
example, a single balloon may be disposed under all the prostheses,
with the sheath retracted to expose only those prostheses to be
deployed. When the balloon is expanded, the balloon will expand the
exposed prostheses, with expansion of the prostheses which remain
covered being restrained by the sheath. By further retracting the
sheath, the previously undeployed prostheses may then be deployed.
Optionally, the prostheses are advanced (or at least axially
restrained relative to the sheath) by a pusher tube which engages a
proximal end of the proximal-most prosthesis.
[0034] As an alternative to balloon expansion, the uncovered
prostheses may be expanded by exposure to heat. The heat may be
applied by directing a heated medium to the prostheses, directing
electrical energy through the prostheses, and/or energizing a
heating element positioned adjacent to the uncovered
prostheses.
[0035] In preferred aspects of the methods of the present
invention, the body lumen will be a blood vessel, preferably a
coronary artery, a cerebral artery, or other small artery. The
prostheses will preferably be coated with biologically active or
inert agent, such as an agent selected to inhibit hyperplasia, more
specifically being any of the particular agents set forth
hereinabove.
[0036] The catheters of the present invention will comprise a
number of coaxial components, such as sheaths, pusher tubes,
catheter bodies, and the like. While it will often be described
that stents or other prostheses are advanced distally from the
sheath, such description will apply to sheaths which are retracted
proximally relative to the prostheses to effect the release. Thus,
all descriptions of direction are meant to be relative.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] FIG. 1 is a perspective view illustrating a stent delivery
catheter constructed in accordance with the principles of the
present invention.
[0038] FIG. 2 is a detailed view of the distal end of the catheter
of FIG. 1 with portions broken away.
[0039] FIGS. 3A-3F illustrate use of the catheter of FIG. 1 for
deploying a plurality of stents using balloon expansion.
[0040] FIG. 4 illustrates an exemplary prosthesis constructed in
accordance with the principles of the present invention.
[0041] FIGS. 5A and 5B illustrate a prosthesis similar to that
shown in FIG. 4, but further including coupling elements for
permitting detachable coupling of adjacent prostheses.
[0042] FIG. 5C illustrates a pair of prostheses, as shown in FIGS.
5A and FIG. 5B, joined together by the coupling elements.
[0043] FIG. 5D illustrates a pair of adjacent prostheses coupled by
a modified coupling element.
[0044] FIGS. 5E and 5F illustrate radial separation of the adjacent
prostheses of FIG. 5C.
[0045] FIGS. 6A and 6B illustrate a second coupling mechanism
constructed in accordance with the principles of the present
invention.
[0046] FIG. 7 illustrates a frangible linkage for joining a pair of
adjacent prostheses.
[0047] FIGS. 8A-8C illustrate a catheter and its use for delivering
self-expanding prostheses according to the methods of the present
invention.
[0048] FIGS. 9A and 9C illustrate an alternative catheter
construction intended for delivering self-expanding prostheses
according to the methods of the present invention.
[0049] FIGS. 10A-10C illustrates use of the catheter for delivering
prostheses by a heat-induction method in accordance with the
principles of the present invention.
[0050] FIG. 11 illustrates an alternative catheter construction for
delivering multiple prostheses via a heat-induction protocol in
accordance with the principles of the present invention.
[0051] FIGS. 12A-12D illustrate a catheter for delivering multiple
prostheses using balloon expansion in accordance with the methods
of the present invention.
[0052] FIGS. 13A-13D illustrate a catheter including a stent valve
for delivering multiple prostheses using balloon expansion in
accordance with the methods of the present invention.
[0053] FIG. 14 illustrates an exemplary kit constructed in
accordance with the principles of the present invention.
DETAILED DESCRIPTION OF THE SPECIFIC EMBODIMENTS
[0054] Referring now to FIG. 1, the stent delivery catheter 10
comprises a catheter body 12 having a proximal end 14 and a distal
end 16. The catheter body is formed from a conventional catheter
material, such as braided or coiled stainless steel, a natural or
synthetic polymer, including silicone rubber, polyethylene,
polyvinylchloride, polyurethane, polyester,
polytetrafluoroethylene, nylon, and the like. The body may be
formed as a composite having one or more reinforcement layers
incorporated within a polymeric shell in order to enhance strength,
flexibility, and toughness. For intravascular use, the catheter
body will typically have a length in the range from 40 cm to 150
cm, usually being between 40 cm and 120 cm for peripheral blood
vessels and between 110 cm and 150 cm for coronary arteries. The
outer diameter of the catheter body may vary depending on the
intended use, typically being between 3 French and 15 French,
usually from 5 French to 9 French.
[0055] Catheter 10 will include a handle 18 at its proximal end 14.
The handle may include a guidewire port 20 and a balloon inflation
port 22, as well as a handle grip 24 which advances a pusher shaft
whose distal end 26 is shown in FIG. 2. Additionally, the handle
permits reciprocation of a catheter delivery balloon 28, also shown
in FIG. 2.
[0056] A plurality of stents 30 are carried in a lumen of the
catheter body 12, as shown in FIG. 2. While three stents 30 are
shown, it will be appreciated that additional stents may be carried
generally within the ranges disclosed above. The illustrated stents
comprise a plurality of serpentine ring structures joined by offset
struts. It will be appreciated, however, that a wide variety of
stent structures could be carried by the catheter 10, generally as
described above.
[0057] Referring now to FIGS. 3A-3F, the distal end 16 of the
catheter 10 is advanced to target location 40 within a diseased
blood vessel (BV) over a guidewire 42, as illustrated in FIG. 3B.
Balloon 28 carries a first of the three stents 30, and is advanced
distally from the catheter to deploy the stent within the treatment
region 40, as illustrated in FIG. 3B (optionally by retracting the
catheter body 12 proximally relative to balloon 28). Once the stent
30 is properly located, the balloon 28 is inflated to deploy the
stent (and optionally dilate the treatment region), as illustrated
in FIG. 3C.
[0058] The balloon is then deflated, and retracted back into the
distal end of the catheter 16, as illustrated in FIG. 3D. The
expanded stent is left in place. The balloon 28 is retracted back
to within the second stent 30, as illustrated in FIG. 3E. The
second stent has been advanced using the pusher 26 so that it is
properly located over the balloon 28, and the distal end of the
catheter 16 may then be advanced so that the second stent 30 is
located within a second treatment region spaced apart from the
first treatment region. As illustrated in FIG. 3F, the treatment
regions are adjacent to each other. It will be appreciated,
however, that the second treatment region could be spaced a
substantial distance from the first treatment region. Deployment of
the second stent 30 is then completed in the same manner as
described above for the first stent. Similarly, deployment of
third, fourth, fifth, and additional stents 30 may be effected in
the same manner. In this way, it will be appreciated that
relatively lengthy and/or disseminated regions within a blood
vessel may be treated.
[0059] Referring now to FIG. 4, an exemplary prosthesis 50
constructed in accordance with the principles of the present
invention is illustrated. The prosthesis has a tubular body 52
having a plurality of axial slots 54, typically formed by laser
cutting or chemical etching a tubular stock, such as stainless
steel or nickel-titanium hypotube. Prosthesis 50, which may be
delivered in groups of two, three, four, or more in accordance with
the principles of the present invention, will have a length within
the ranges set forth above. The diameter, prior to expansion, will
typically be below 2 mm, preferably being below 1 mm, although in
some instances much larger diameters can be used. The diameter of
the prosthesis 50 upon expansion, of course, will be much greater,
typically being at least twice as large, sometimes being at least
three times as large, or even larger.
[0060] Referring now to FIGS. 5A and 5B, a prosthesis 60, similar
to prosthesis 50, includes a pair of coupling elements 62 which are
received in mating slots 64. FIG. 5B is a "rolled-out" view of the
"rolled-out" view of the prosthesis 60 for better illustrating the
coupling element 62 and slots 64 of the prosthesis 60.
[0061] As shown in FIG. 5C, pairs of prosthesis 60 may be joined or
coupled by circumferentially aligning the coupling element 62 with
the slot 64. Although only a single coupling element 62 and slot 64
is visible in FIG. 5C, it will be appreciated that the second
coupling element and slot will be located on the opposite side of
the illustrated pair of prostheses.
[0062] In FIG. 5C, the two prosthesis 60 are abutted directly
against each other. Such a configuration is advantageous in that it
provides for a substantially continuous stent or graft structure
when the pair is expanded together in a body lumen. The structure,
however, is disadvantageous in that it does not provide for
flexibility at the point where the two prostheses meet. In order to
provide for greater flexibility, as shown in FIG. 5D, a coupling
element 62' can have an elongated shank to provide for a desired
offset, typically in the range from 0.05 mm to 1 mm, preferably
from 0.1 mm to 0.5 mm.
[0063] Referring now to FIGS. 5E and 5F, axial separation of the
prostheses 60 is achieved by differential radial expansion of at
least one of the prostheses. For example, when both prostheses 60
are in their unexpanded configurations, as shown in FIG. 5E, the
coupling elements 62 are constrained by the slots 64, as previously
described. By radially expanding the left-hand prostheses 60, as
shown in FIG. 5F, the coupling elements 62 will be moved radially
outwardly from the slots so that the two prostheses are no longer
axially linked. It will be appreciated, however, that the two
prostheses 60 may be radially expanded together (as described in
more detail hereinafter) in a manner which preserves the link
created by the coupling elements 62 and slots 64 so that
combinations of two, three, four, or more prostheses may be
delivered simultaneously and, in effect, provide a continuous
prosthesis having a length which is some multiple of the length of
each individual prostheses 60. The combined prostheses may then be
separated from any additional prostheses (which remain in a
delivery catheter as described below) by the radial expansion of
those prostheses which are to be deployed. In this way, stents,
grafts, or other prostheses may be delivered to the body lumen in
both different lengths (by properly selecting the number of
individual prostheses 60) and at different locations (by releasing
individual or multiple prostheses 60 at different portions of the
body lumen).
[0064] Axially separable coupling elements may also be provided, as
illustrated in FIGS. 6A and 6B. Each prosthesis 70 includes a pair
of male coupling elements 72 at one end and a pair of female
coupling elements 74 at the other end. The male coupling elements
72 are typically short rods which extend axially from the periphery
of the prosthesis end and the female coupling elements are
typically short tubes having hollow interiors which detachably
receive the male coupling elements. Thus, the prostheses 70 may be
joined in an end-to-end manner, as shown in FIG. 6B. The prostheses
are separated by pulling them in an axial direction, as shown by
arrow 76, but will remain linked under axial compression as well as
when exposed to a substantial bending moment. Thus, the axially
separable coupling structures of FIGS. 6A and 6B are advantageous
in that they remain linked during deployment of the prostheses 70,
even when deployment involves significant bending and radial
stress. Separation may be effected by pullback on the delivery
catheter in order to disengage the coupling elements 72 and 74.
[0065] A third approach for detachably coupling adjacent prostheses
80 is illustrated in FIG. 7. Each prosthesis 80 comprises an
expansible ring of diamond-shaped members. Other conventional stent
or prostheses structures, however, could also be used. The adjacent
prostheses 80 are joined by an axial beam 82 which preferably
includes a weakened segment 84 near its midpoint. The use of such a
joining structure, which will require physical breakage (as opposed
to the simple detachment characteristic of the embodiment of FIGS.
5 and 6) is advantageous in that it provides a very strong linkage
which permits both the application of axial compression and axial
tension without decoupling. The disadvantage of such a linkage is
that it usually requires some mechanism or capability to be
incorporated in the delivery catheter to permit selective breakage
of the couple.
[0066] Referring now to FIGS. 8A-8C, a catheter 100 suitable for
delivering a plurality of self-expanding prostheses 102 will be
described. Catheter 100 comprises a sheath 104 having an axial
lumen which carries the prostheses 102 near its distal end 106. A
pusher tube 108 is also positioned in the lumen and is located
proximally of the proximal most prosthesis 102. The individual
prostheses 102 may be delivered into a body lumen, typically a
blood vessel BV, as illustrated in FIG. 8B. The catheter is
introduced over a guidewire GW to a desired target site in the
blood vessel BV. When at the target site, a first of the prostheses
102 is deployed by axially advancing the pusher tube 104 so that
the line of prostheses 102 is axially advanced, with the
distal-most prostheses being released from the distal end 106 of
the catheter. As it is released, the distal-most prostheses 102
expands since it is being released from the radial constraint
provided by the sheath 104.
[0067] Catheter 100 of FIGS. 8A-8C is intended for delivering
prostheses which abut each other in an end-to-end manner, but which
are otherwise unconnected. A catheter 120 intended for releasing
self-expanding prostheses 122 which are mechanically linked by
frangible coupling elements 124 is illustrated in FIGS. 9A-9C. The
prostheses 122 and coupling elements 124 may be similar to the
prosthesis structure shown in FIG. 7, or may comprise other linked
prosthesis or stent structures, for example as shown in U.S. Pat.
No. 6,258,117, the disclosure of which is incorporated herein by
reference.
[0068] Catheter 120 comprises a sheath 126, a pusher tube 128, and
a catheter body 130 having a shearing element 132 at its distal
end. Conveniently, the pusher tube 128 is coaxially received over a
shaft 134 of the catheter body 130. In this way, the pusher tube
may be used to axially advance each prosthesis 122 by pushing on
the proximal end of the proximal-most prosthesis, as shown in FIG.
9B.
[0069] The catheter 120 is advanced over a guidewire GW to a
desired target site in a blood vessel BV. After reaching the target
site, at least a first prosthesis 122 is advanced from the distal
end of the sheath so that it radially expands to engage an inner
wall of the blood vessel. After the at least one prosthesis 122 is
advanced sufficiently far, the frangible coupling elements 124 will
reach a shearing element 136, typically a metal ring, disposed at
the distal end of the sheath 126. By then axially retracting the
catheter body 130, a chamfered surface 138 of the shearing element
132 is engaged against the shearing element 136 in order to shear
the links 122, releasing the prosthesis 122, as illustrated in FIG.
9C. After deployment and release of the first prosthesis 122,
additional prosthesis 122 may be released adjacent to the first
prosthesis or at different, axially spaced-apart locations within
the blood vessel.
[0070] Referring now to FIGS. 10A-10C, a catheter 140 for
delivering a plurality of heat expansible prostheses 142 is
illustrated. The prostheses 142 are composed of a heat memory
alloy, such as a nickel titanium alloy, which has been programmed
to remain in an unexpanded configuration when maintained at body
temperature or below, and to assume an expanded configuration when
exposed to temperatures above body temperature, typically
temperatures above 43.degree. C., often above 45.degree. C. The
prostheses will have coupling members which anchor successive
prostheses 142 together, typically the radially separating anchors
illustrated in FIGS. 5A-5F.
[0071] The catheter 140 includes a sheath 144 and a pusher tube
146. The catheter 140 is advanced to a desired target site within
the blood vessel BV over a guidewire GW in a conventional manner.
After the distal-most prostheses 142 has been fully advanced from
the sheath 144 (usually by retracting the sheath 144 while the
prostheses are held stationary relative to the blood vessel BV
using the pusher tube 146), as shown in FIG. 10B, it will remain
both unexpanded and attached to the next proximal prosthesis 142
which remains within the sheath. It is important that the advanced
prosthesis 142 be anchored or tethered to the remaining prostheses
since it has not yet been expanded and it would otherwise be lost
into the lumen of the blood vessel.
[0072] After the uncovered prostheses is properly positioned, a
heated medium may be introduced through a lumen of the catheter
body 148 so that it flows outwardly through the interior of the
distal-most prosthesis 142. By properly selecting the temperature
of the heated medium, the prosthesis to be deployed can be heated
sufficiently to induce radial expansion, as illustrated in FIG.
10C. By positioning the catheter body 148 so that its distal tip is
coterminous with the distal tip of the sheath 144, inadvertent
heating of the prostheses 142 which remain within the sheath can be
avoided. After the prosthesis 142 has radially expanded, it will
separate from the coupling elements 148 located on the next
prosthesis which remains within the sheath 144. Additional ones or
groups of prostheses 142 may then be deployed, either at the same
target site or at a different target site axially spaced-apart
within the lumen of the blood vessel BV.
[0073] As illustrated in FIG. 11, instead of using an internal
catheter body 148, as illustrated in FIGS. 10A-10C, an external
sheath 150 may be used to deliver the heated medium around one or
more deployed prostheses 142. Other aspects of the construction of
catheter 140 may remain the same. Optionally, if prosthesis is
martensitic at body temperature, further radial expansion can be
achieved by internal balloon expansion.
[0074] Referring now to FIGS. 12A-12D, catheter 160 intended for
delivery of multiple prostheses 162 by balloon deployment is
illustrated. Catheter 160 comprises a sheath 164, pusher tube 166,
and a catheter body 168. The catheter body 168 includes an
expansible balloon 170 over its distal portion. Individual
prostheses 162 are deployed, as illustrated in FIGS. 12B and 12C,
by crossing the target area with catheter 160 and then retracting
sheath 164. A distal portion of the balloon 170 lies within the
distal-most deployed prosthesis 162, as shown in FIG. 12B. The
remaining proximal portion of the balloon 170 will, of course,
remain within the other prostheses 162 which themselves remain
within the sheath 164. The balloon 170 is then inflated, but only
the distal portion of the balloon beyond the sheath inflates within
the distal prosthesis 162, as illustrated in FIG. 12C. Expansion of
the remaining proximal portion of the balloon is prevented by the
sheath 164. Similarly, the remaining prostheses 162 remain
unexpanded since they remain within the sheath 164. After
deployment of prostheses 162, balloon 170 may be deflated and
retracted into sheath 164 and remaining prostheses 162.
[0075] Referring now to FIG. 12D, additional prostheses 162 may be
deployed, either at the same target location within the blood
vessel or at a different, spaced-apart locations within the blood
vessel. Deployment of two prostheses 162 is illustrated. The two
prostheses 162 are axially exposed as the sheath is retracted over
the stents which are positioned over the uninflated balloon 170.
The balloon 170 is then inflated, as illustrated in FIG. 12D, thus
expanding the prostheses 162 within the blood vessel BV. It will be
appreciated that the catheter 160 could carry many more than the
four illustrated prostheses 162, and three, four, five, ten, and
even 20 or more individual prostheses could be deployed at one
time, with additional single prostheses or groups of prostheses
being deployed at different times and/or at different locations
within the blood vessel.
[0076] Referring now to FIGS. 13A-13D, another embodiment of a
catheter 180 intended for delivery of multiple prostheses 182 by
balloon deployment is illustrated. In this embodiment, catheter 180
comprises a sheath 184 having a valve member 185 at its distal end,
a pusher tube 186, and a catheter body 188. The catheter body 188
includes an expansible balloon 190 over its distal portion. To
deploy prostheses 182, as illustrated in FIG. 13B, a predetermined
number of prostheses 182 is first exposed by retracting sheath 184
proximally (arrows) while holding pusher tube 186 in place. As
shown in FIGS. 13B and 13C, valve member 185 may be used to engage
a distal end of one of the prostheses 182 and the sheath 184 and
the pusher tube may be retracted proximally together (arrows in
FIG. 13C) to separate a proximal number of prostheses 182 from a
distal number of prostheses 182. The distal portion of the balloon
190 lies within the distal, deployed prostheses 182. The remaining
proximal portion of the balloon 190 will remain within the other
prostheses 182 which themselves remain within the sheath 184. The
balloon 190 is then inflated, as shown in FIG. 13D, but only the
distal portion of the balloon inflates within the distal prostheses
182, as illustrated in FIG. 12C. Expansion of the remaining
proximal portion of the balloon is prevented by the sheath 184.
Similarly, the remaining prostheses 182 remain unexpanded since
they remain within the sheath 184.
[0077] Referring now to FIG. 13D, single or multiple prostheses 182
may be deployed at the same target location within the blood
vessel. Additional prostheses 182 may also be deployed at
different, spaced-apart locations within the blood vessel.
Deployment of two prostheses 182 is illustrated at one location in
FIG. 13D. It will be appreciated that the catheter 180 could carry
many more than the four illustrated prostheses 182, and three,
four, five, ten, and even 20 or more individual prostheses could be
deployed at one time, with additional single prostheses or groups
of prostheses being deployed at different times and/or at different
locations within the blood vessel.
[0078] Referring now to FIG. 14, kits 200 according to the present
invention comprise a catheter 160 (or any other of the illustrated
catheters of the present invention) in combination with
instructions for use IFU. The instructions for use set forth any of
the methods of the present invention, and in particular set forth
how the catheter 180 may be used to implant single or multiple
prostheses within a blood vessel or other body lumen. The catheter
180 and instructions for use will typically be packaged together,
for example within a conventional package 202, such as a box, tube,
pouch, tray, or the like. Catheter 160 will typically be maintained
in a sterile condition within the package 202. The instructions for
use may be provided on a package insert, may be printed in whole or
in part on the packaging, or may be provided in other ways, such as
electronically over the internet, on an electronic medium, such as
a CD, DVD, or the like.
[0079] The preferred embodiments of the invention are described
above in detail for the purpose of setting forth a complete
disclosure and for the sake of explanation and clarity. Those
skilled in the art will envision other modifications within the
scope and sprit of the present disclosure.
* * * * *