U.S. patent application number 14/151107 was filed with the patent office on 2015-07-09 for balloon catheter with elastomeric sheath and methods.
This patent application is currently assigned to Medtronic Vascular, Inc.. The applicant listed for this patent is Medtronic Vascular, Inc.. Invention is credited to John Kantor.
Application Number | 20150190618 14/151107 |
Document ID | / |
Family ID | 52396835 |
Filed Date | 2015-07-09 |
United States Patent
Application |
20150190618 |
Kind Code |
A1 |
Kantor; John |
July 9, 2015 |
Balloon Catheter With Elastomeric Sheath and Methods
Abstract
Balloon catheters that include a balloon and an elastomeric
sheath, each having a surface with a therapeutic agent disposed
thereon, along with methods of making and methods of using the
disclosed balloon catheters.
Inventors: |
Kantor; John; (Healdsburg,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic Vascular, Inc. |
Santa Rosa |
CA |
US |
|
|
Assignee: |
Medtronic Vascular, Inc.
Santa Rosa
CA
|
Family ID: |
52396835 |
Appl. No.: |
14/151107 |
Filed: |
January 9, 2014 |
Current U.S.
Class: |
604/509 ;
156/249; 156/294; 604/103.02 |
Current CPC
Class: |
B32B 38/10 20130101;
A61M 2025/1031 20130101; A61M 2025/1004 20130101; A61M 25/10
20130101; A61M 2025/1068 20130101; A61M 25/1002 20130101; B05D
1/286 20130101; B32B 43/006 20130101; B32B 37/142 20130101; A61M
2025/1081 20130101; A61M 25/1038 20130101; A61M 2025/105 20130101;
B32B 2535/00 20130101 |
International
Class: |
A61M 25/10 20060101
A61M025/10; B32B 38/10 20060101 B32B038/10; B32B 43/00 20060101
B32B043/00; B32B 37/14 20060101 B32B037/14 |
Claims
1. A balloon catheter comprising: an elongated catheter shaft
having proximal and distal ends, wherein the catheter shaft defines
a longitudinal axis extending between the proximal and distal ends;
an inflatable balloon located close to the distal end of the
catheter shaft, wherein the balloon comprises a polymeric material
having a surface with a first therapeutic agent disposed thereon;
and an elastomeric sheath comprising an elastomeric material having
a surface with a second therapeutic agent disposed thereon; wherein
in a first configuration the inflatable balloon is located within
the elastomeric sheath such that expansion of the inflatable
balloon to an inflated state expands the elastomeric sheath, and
wherein in a second configuration the inflatable balloon is located
outside of the elastomeric sheath, and further wherein the balloon
and the elastomeric sheath are configured for movement relative to
each other along the longitudinal axis between the first
configuration and the second configuration when deployed within a
body lumen.
2. The balloon catheter of claim 1 wherein the inflatable balloon
is in a folded state when in the first configuration.
3. The balloon catheter of claim 1 wherein the first and second
therapeutic agents are different therapeutic agents.
4. The balloon catheter of claim 1 wherein the first and second
therapeutic agents are the same therapeutic agent.
5. The balloon catheter of claim 1 wherein the first and second
therapeutic agents are at different concentrations.
6. The balloon catheter of claim 1 wherein the first and second
therapeutic agents are at the same concentrations.
7. The balloon catheter of claim 1 further comprising a protective
sheath positioned around the elastomeric sheath, wherein the
protective sheath is configured for movement relative to the
elastomeric sheath along the longitudinal axis, when deployed in a
body lumen, between a first configuration in which the elastomeric
sheath is positioned within the protective sheath and a second
configuration in which at least a portion of the elastomeric sheath
is located outside of the protective sheath.
8. A method of manufacturing the balloon catheter of claim 1, the
method comprising: providing an elongated catheter shaft having
proximal and distal ends with an inflatable balloon located close
to the distal end of the catheter shaft, wherein the balloon
comprises a polymeric material having a surface; positioning a
delivery sheath around the balloon, wherein the delivery sheath
comprises a polymeric material having a therapeutic agent
impregnated therein or coated thereon; and applying conditions
effective to transfer the therapeutic agent from the delivery
sheath to the surface of the inflatable balloon.
9. The method of claim 8 further comprising: removing the delivery
sheath from the balloon; positioning an elastomeric sheath around
the balloon, wherein the elastomeric sheath comprises an
elastomeric material having a surface; positioning a delivery
sheath around the elastomeric sheath, wherein the delivery sheath
comprises a polymeric material having a therapeutic agent
impregnated therein or coated thereon; and applying conditions
effective to transfer the therapeutic agent from the delivery
sheath to the surface of the elastomeric sheath.
10. A method of delivering one or more therapeutic agents to a
diseased vessel, the method comprising: providing a balloon
catheter of claim 1; advancing the balloon catheter into the
diseased vessel; inflating the inflatable balloon to form an
inflated balloon and an expanded sheath that contacts the wall of
the diseased vessel and thereby delivers the second therapeutic
agent from the surface of the expanded sheath to a first site of
the diseased vessel; deflating the inflated balloon to reform the
inflatable balloon into a reformed inflatable balloon; removing the
elastomeric sheath from around the reformed inflatable balloon; and
inflating the reformed inflatable balloon to contact the wall of
the diseased vessel with the first therapeutic agent to deliver the
first therapeutic agent from the surface of the inflated balloon to
the first site, or to a different site of the same or a different
diseased vessel if the reformed inflatable balloon is moved to the
different site after the expanded sheath contacts the wall of the
diseased vessel and before inflating the reformed inflatable
balloon.
11. A method of delivering one or more therapeutic agents to a
diseased vessel, the method comprising: providing a balloon
catheter comprising: an elongated catheter shaft having proximal
and distal ends; a folded inflatable balloon located close to the
distal end of the catheter shaft, wherein the balloon comprises a
polymeric material having a surface with a first therapeutic agent
disposed thereon; and an elastomeric sheath positioned around the
folded inflatable balloon such that the inflatable balloon is
located within the elastomeric sheath, wherein the sheath comprises
an elastomeric material having a surface with a second therapeutic
agent disposed thereon; advancing the balloon catheter into the
diseased vessel; inflating the folded inflatable balloon to form an
inflated balloon and an expanded sheath that contacts the wall of
the diseased vessel and thereby delivers the second therapeutic
agent from the surface of the expanded sheath to a first site of
the diseased vessel; deflating the inflated balloon after
delivering the second therapeutic agent to the first site to reform
the inflatable balloon into a reformed inflatable balloon; removing
the elastomeric sheath from around the reformed inflatable balloon;
and inflating the reformed inflatable balloon to contact the wall
of the diseased vessel with the first therapeutic agent to deliver
the first therapeutic agent from the surface of the inflated
reformed inflatable balloon to the first site, or to a different
site of the same or a different diseased vessel if the reformed
inflatable balloon is moved to the different site after the
expanded sheath contacts the wall of the diseased vessel and before
inflating the reformed inflatable balloon.
12. The method of claim 11 wherein the balloon catheter further
comprises a protective sheath positioned around the elastomeric
sheath and the inflatable balloon located in the elastomeric
sheath, and the method further comprises removing the protective
sheath from the elastomeric sheath after advancing the balloon
catheter into the diseased vessel.
13. The method of claim 11 wherein the diseased vessel comprises a
vascular lesion having a length that is longer than the length of
the balloon.
14. The method of claim 11 wherein removing the elastomeric sheath
from around the reformed inflatable balloon comprises retracting
the sheath towards the proximal end of the catheter shaft.
15. The method of claim 11 wherein removing the elastomeric sheath
from around the reformed inflatable balloon comprises advancing the
reformed inflatable balloon to a second site of the diseased vessel
that is distal from the first site.
16. The method of claim 11 wherein the elastomeric sheath is longer
than the inflatable balloon; and wherein after inflating the
inflatable balloon to form the inflated balloon and the expanded
sheath and prior to removing the elastomeric sheath from around the
reformed inflatable balloon, the method comprises: retracting the
inflatable balloon proximally towards the proximal end of the
catheter shaft within the elastomeric sheath; inflating the
inflatable balloon after retracting the inflatable balloon
proximally so that the elastomeric sheath contacts the wall of the
diseased vessel and thereby delivers the second therapeutic agent
to a second site that is located proximally from the first site of
the diseased vessel; and deflating the inflated balloon after
delivering the second therapeutic agent at the second site.
17. A method of delivering one or more therapeutic agents to a
diseased vessel, the method comprising: providing a balloon
catheter comprising: an elongated catheter shaft having proximal
and distal ends; an inflatable balloon located close to the distal
end of the catheter shaft, wherein the balloon has a proximal end
and a distal end, and wherein the balloon comprises a polymeric
material having a surface with a first therapeutic agent disposed
thereon; an elastomeric sheath positioned around the inflatable
balloon such that the inflatable balloon is located within the
elastomeric sheath, wherein the sheath comprises an elastomeric
material having a surface with a second therapeutic agent disposed
thereon, and wherein the elastomeric sheath is longer than the
inflatable balloon; and a protective sheath positioned around the
elastomeric sheath and the inflatable balloon; advancing the
balloon catheter into the diseased vessel; retracting the
protective sheath towards the proximal end of the catheter shaft so
that the inflatable balloon is not located in the protective
sheath; inflating the inflatable balloon to form an inflated
balloon and an expanded sheath that contacts the wall of the
diseased vessel and thereby delivers the second therapeutic agent
from the surface of the expanded sheath to a first site of the
diseased vessel; deflating the inflated balloon after delivering
the second therapeutic agent to the first site to reform the
inflatable balloon into a reformed inflatable balloon; retracting
the protective sheath proximally towards the proximal end of the
catheter shaft so that the reformed inflatable balloon is not
located in the protective sheath after delivering the second
therapeutic agent to the first site; retracting the reformed
inflatable balloon proximally towards the proximal end of the
catheter shaft within the elastomeric sheath; inflating the
reformed inflatable balloon so that the elastomeric sheath contacts
the wall of the diseased vessel and thereby delivers the second
therapeutic agent to a second site that is located proximally from
the first site of the diseased vessel; deflating the reformed
inflated balloon to again reform a reformed inflatable balloon
after delivering the second therapeutic agent to the second site;
retracting the elastomeric sheath proximally towards the proximal
end of the catheter shaft so that the reformed inflatable balloon
is not located in the protective sheath or the elastomeric sheath
after delivering the second therapeutic agent to the second site;
and inflating the reformed inflatable balloon to form an inflated
balloon that contacts the wall of the diseased vessel and thereby
delivers the first therapeutic agent from the surface of the
inflated balloon to the second site of the diseased vessel, or to a
third site of the diseased vessel if the inflated balloon is moved
to the different site after delivering the second therapeutic agent
to the second site.
Description
BACKGROUND
[0001] Using targeted delivery, a controlled dose of a therapeutic
agent may be delivered directly to a target site, e.g., a lesion in
a diseased vessel, while avoiding or minimizing exposing other
parts of the body to the agent. Also, greater amounts of
therapeutic agent may be delivered to the afflicted parts of the
body. In one approach to localized delivery, a balloon catheter is
used, wherein the balloon has therapeutic agent disposed on its
outer surface and is expanded within a vessel to deliver the
therapeutic agent to the vessel wall. In an alternative approach,
an expandable sheath is disposed around a balloon and a coating
disposed on the expandable sheath, the coating including a
therapeutic agent. There is still a need for improved balloon
catheter devices for delivery of one or more therapeutic agents to
an intravascular site.
SUMMARY
[0002] The present disclosure provides balloon catheters that
include a balloon and an elastomeric sheath, each having a surface
with a therapeutic agent disposed thereon. The present disclosure
also provides methods of making and methods of using the disclosed
balloon catheters.
[0003] In one embodiment of the present disclosure, there is
provided a balloon catheter that includes: an elongated catheter
shaft having proximal and distal ends, wherein the catheter shaft
defines a longitudinal axis extending between the proximal and
distal ends; an inflatable balloon (preferably, in a folded
inflatable state) located close to the distal end of the catheter
shaft, wherein the balloon includes a polymeric material having a
surface with a first therapeutic agent disposed thereon; and an
elastomeric sheath including an elastomeric material having a
surface with a second therapeutic agent disposed thereon; wherein
in a first configuration the inflatable balloon is located within
the elastomeric sheath such that expansion of the inflatable
balloon to an inflated state expands the elastomeric sheath, and
wherein in a second configuration the inflatable balloon is located
outside of the elastomeric sheath, and further wherein the balloon
and the elastomeric sheath are configured for movement relative to
each other along the longitudinal axis between the first
configuration and the second configuration when deployed within a
body lumen.
[0004] In certain embodiments, the balloon catheter further
includes a protective sheath positioned around the elastomeric
sheath, wherein the protective sheath is configured for movement
relative to the elastomeric sheath along the longitudinal axis,
when deployed in a body lumen, between a first configuration in
which the elastomeric sheath is positioned within the protective
sheath and a second configuration in which at least a portion of
the elastomeric sheath is located outside of the protective
sheath.
[0005] The present disclosure provides methods of making and
methods of using the disclosed catheter balloons.
[0006] In one embodiment, there is provided a method of
manufacturing a balloon catheter as described herein. The method
includes: providing an elongated catheter shaft having proximal and
distal ends with an inflatable balloon located close to the distal
end of the catheter shaft, wherein the balloon includes a polymeric
material having a surface; positioning a delivery sheath around the
balloon, wherein the delivery sheath includes a polymeric material
having a therapeutic agent impregnated therein or coated thereon;
and applying conditions effective to transfer (e.g., diffuse) the
therapeutic agent from the delivery sheath to the surface of the
inflatable balloon.
[0007] In another embodiment of manufacturing a balloon catheter as
described herein, the method further includes: removing the
delivery sheath from the balloon; positioning an elastomeric sheath
around the balloon, wherein the elastomeric sheath includes an
elastomeric material having a surface; positioning a delivery
sheath around the elastomeric sheath, wherein the delivery sheath
includes a polymeric material having a therapeutic agent
impregnated therein or coated thereon; and applying conditions
effective to transfer (e.g., diffuse) the therapeutic agent from
the delivery sheath to the surface of the elastomeric sheath.
[0008] In certain embodiments, the balloon and the elastomeric
sheath are provided with the therapeutic agent separately provided
(i.e., the elastomeric sheath is previously prepared and provided
with the therapeutic agent, and successively it is combined with a
balloon previously coated with a therapeutic agent).
[0009] In one embodiment of the present disclosure, there is
provided a method of delivering one or more therapeutic agents to a
diseased vessel. The method includes: providing a balloon catheter
as described herein; advancing the balloon catheter into the
diseased vessel; inflating the inflatable balloon to form an
inflated balloon and an expanded sheath that contacts the wall of
the diseased vessel and thereby delivers the second therapeutic
agent from the surface of the expanded sheath to a first site of
the diseased vessel; deflating the inflated balloon to reform the
inflatable balloon into a reformed inflatable balloon; removing the
elastomeric sheath from around the reformed inflatable balloon; and
inflating the reformed inflatable balloon to contact the wall of
the diseased vessel with the first therapeutic agent to deliver the
first therapeutic agent from the surface of the inflated balloon to
the first site, or to a different site of the same or a different
diseased vessel if the reformed inflatable balloon is moved to the
different site after the expanded sheath contacts the wall of the
diseased vessel and before inflating the reformed inflatable
balloon.
[0010] In another embodiment of the present disclosure, there is
provided a method of delivering one or more therapeutic agents to a
diseased vessel. The method includes: providing a balloon catheter
that includes: an elongated catheter shaft having proximal and
distal ends; a folded inflatable balloon located close to the
distal end of the catheter shaft, wherein the balloon includes a
polymeric material having a surface with a first therapeutic agent
disposed thereon; and an elastomeric sheath positioned around the
inflatable balloon such that the inflatable balloon is located
within the elastomeric sheath, wherein the sheath includes an
elastomeric material having a surface with a second therapeutic
agent disposed thereon. The method further includes: advancing the
balloon catheter into the diseased vessel (i.e., one having a
vascular lesion); inflating the folded inflatable balloon to form
an inflated balloon and an expanded sheath that contacts the wall
of the diseased vessel and thereby delivers the second therapeutic
agent from the surface of the expanded sheath to a first site of
the diseased vessel; deflating the inflated balloon after
delivering the second therapeutic agent to the first site to reform
the inflatable balloon into a reformed inflatable balloon (herein,
a "reformed" inflatable balloon may or may not be refolded, and may
or may not be the same degree of "deflation" of the initial
inflatable balloon); removing the elastomeric sheath from around
the reformed inflatable balloon; and inflating the reformed
inflatable balloon to contact the wall of the diseased vessel with
the first therapeutic agent to deliver the first therapeutic agent
from the surface of the inflated reformed inflatable balloon to the
first site, or to a different site of the same or a different
diseased vessel if the reformed inflatable balloon is moved to the
different site after the expanded sheath contacts the wall of the
diseased vessel and before inflating the reformed inflatable
balloon.
[0011] In yet another embodiment of the present disclosure, there
is provided a method of delivering one or more therapeutic agents
to a diseased vessel. The method includes: providing a balloon
catheter that includes: an elongated catheter shaft having proximal
and distal ends; an inflatable balloon (preferably, a folded
inflatable balloon) located close to the distal end of the catheter
shaft, wherein the balloon has a proximal end and a distal end, and
wherein the balloon includes a polymeric material having a surface
with a first therapeutic agent disposed thereon; an elastomeric
sheath positioned around the inflatable balloon such that the
inflatable balloon is located within the elastomeric sheath,
wherein the sheath includes an elastomeric material having a
surface with a second therapeutic agent disposed thereon, and
wherein the elastomeric sheath is longer than the inflatable
balloon; and a protective sheath positioned around the elastomeric
sheath and the inflatable balloon. The method further includes:
advancing the balloon catheter into the diseased vessel; retracting
the protective sheath towards the proximal end of the catheter
shaft so that the inflatable balloon is not located in the
protective sheath; inflating the inflatable balloon to form an
inflated balloon and an expanded sheath that contacts the wall of
the diseased vessel and thereby delivers the second therapeutic
agent from the surface of the expanded sheath to a first site of
the diseased vessel; deflating the inflated balloon to reform the
inflatable balloon into a reformed inflatable balloon (herein, this
"first reformed" inflatable balloon may or may not be refolded, and
may or may not be the same degree of "deflation" of the initial
inflatable balloon); retracting the protective sheath proximally
towards the proximal end of the catheter shaft so that the reformed
inflatable balloon is not located in the protective sheath after
delivering the second therapeutic agent to the first site;
retracting the reformed inflatable balloon proximally towards the
proximal end of the catheter shaft within the elastomeric sheath
(after delivering the second therapeutic agent to the first site);
inflating the reformed inflatable balloon (after retracting the
reformed inflatable balloon and the protective sheath proximally)
so that the elastomeric sheath contacts the wall of the diseased
vessel and thereby delivers the second therapeutic agent to a
second site that is located proximally from the first site of the
diseased vessel; and deflating the reformed inflated balloon to
again reform a reformed inflatable balloon after delivering the
second therapeutic agent to the second site (herein, a "second
reformed" inflatable balloon may or may not be refolded, and may or
may not be the same degree of "deflation" of the initial inflatable
balloon or the "first reformed" inflatable balloon); retracting the
elastomeric sheath proximally towards the proximal end of the
catheter shaft an that the reformed inflatable balloon is not
located in the protective sheath or the elastomeric sheath after
delivering the second therapeutic agent to the second site; and
inflating the reformed inflatable balloon (after retracting the
elastomeric sheath proximally) to form an inflated balloon that
contacts the wall of the diseased vessel and thereby delivers the
first therapeutic agent from the surface of the inflated balloon to
the second site of the diseased vessel or to a third site of the
diseased vessel if the inflated balloon is moved to a different
site after delivering the second therapeutic agent to the second
site.
[0012] The terms "distal" and "proximal" are used in the following
description with respect to a position or direction relative to the
treating clinician. "Distal" or "distally" are a position distant
from or in a direction away from the clinician. "Proximal" and
"proximally" are a position near or in a direction toward the
clinician.
[0013] Herein, "located close to the distal end of the catheter
shaft" means located closer to the distal end of the catheter shaft
than the proximal end of the catheter shaft. Preferably, in certain
embodiments "located close to the distal end of the catheter shaft"
means located at the ultimate distal end of the catheter shaft.
[0014] The terms "polymer" and "polymeric material" (including
elastomer and elastomeric polymer) include, but are not limited to,
homopolymers, copolymers, such as for example, block, graft, random
and alternating copolymers, terpolymers, etc., and blends and
modifications thereof. Furthermore, unless otherwise specifically
limited, the term "polymer" shall include all possible geometrical
configurations of the material. These configurations include, but
are not limited to, isotactic, syndiotactic, and atactic
symmetries.
[0015] The term "comprises" and variations thereof do not have a
limiting meaning where these terms appear in the description and
claims. Such terms will be understood to imply the inclusion of a
stated step or element or group of steps or elements but not the
exclusion of any other step or element or group of steps or
elements. By "consisting of" is meant including, and limited to,
whatever follows the phrase "consisting of." Thus, the phrase
"consisting of" indicates that the listed elements are required or
mandatory, and that no other elements may be present. By
"consisting essentially of" is meant including any elements listed
after the phrase, and limited to other elements that do not
interfere with or contribute to the activity or action specified in
the disclosure for the listed elements. Thus, the phrase
"consisting essentially of" indicates that the listed elements are
required or mandatory, but that other elements are optional and may
or may not be present depending upon whether or not they materially
affect the activity or action of the listed elements.
[0016] The words "preferred" and "preferably" refer to embodiments
of the disclosure that may afford certain benefits, under certain
circumstances. However, other embodiments may also be preferred,
under the same or other circumstances. Furthermore, the recitation
of one or more preferred embodiments does not imply that other
embodiments are not useful, and is not intended to exclude other
embodiments from the scope of the disclosure.
[0017] In this application, terms such as "a," "an," and "the" are
not intended to refer to only a singular entity, but include the
general class of which a specific example may be used for
illustration. The terms "a," "an," and "the" are used
interchangeably with the term "at least one."
[0018] The phrases "at least one of" and "comprises at least one
of" followed by a list refers to any one of the items in the list
and any combination of two or more items in the list.
[0019] As used herein, the term "or" is generally employed in its
usual sense including "and/or" unless the content clearly dictates
otherwise. The term. "and/or" means one or all of the listed
elements or a combination of any two or more of the listed
elements.
[0020] Also herein, all numbers are assumed to be modified by the
term "about" and preferably by the term "exactly." As used herein
in connection with a measured quantity, the term "about" refers to
that variation in the measured quantity as would be expected by the
skilled artisan making the measurement and exercising a level of
care commensurate with the objective of the measurement and the
precision of the measuring equipment used.
[0021] Also herein, the recitations of numerical ranges by
endpoints include all numbers subsumed within that range as well as
the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,
5, etc.). Herein, "up to" a number (e.g., up to 50) includes the
number (e.g., 50).
[0022] The above summary of the present disclosure is not intended
to describe each disclosed embodiment or every implementation of
the present disclosure. The description that follows more
particularly exemplifies illustrative embodiments. In several
places throughout the application, guidance is provided through
lists of examples, which examples may be used in various
combinations. In each instance, the recited list serves only as a
representative group and should not be interpreted as an exclusive
list.
DRAWINGS
[0023] The disclosure may be more completely understood in
connection with the following drawings.
[0024] FIG. 1 is a partial longitudinal section of an exemplary
embodiment of a balloon catheter with an elastomeric sheath;
[0025] FIG. 2 is a partial longitudinal section of an exemplary
embodiment of a balloon catheter with an elastomeric sheath and an
optional protective sheath;
[0026] FIG. 3A-3C disclose the steps of a method of delivering a
therapeutic agent to a diseased vessel according to an embodiment
of the present disclosure, and
[0027] FIG. 4A-4D disclose the steps of a method of delivering a
therapeutic agent to a diseased vessel according to a further
embodiment of the present disclosure.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0028] The present disclosure relates to balloon catheters that
include a balloon and an elastomeric sheath, each having a surface
with a therapeutic agent disposed thereon.
Balloon Catheter
[0029] Referring to FIG. 1, in one exemplary embodiment of the
present disclosure, there is provided a balloon catheter 10 that
includes: an elongated catheter shaft 12 having a proximal end 14
and a distal end 16, wherein the catheter shaft defines a
longitudinal axis 18 extending between the proximal end 14 and
distal end 16; a balloon 15 in an inflatable state (preferably, in
a folded state) located close to the distal end 16 of the catheter
shaft 12 (i.e., closer to the distal end 16 of the catheter shaft
12 than the proximal end 14 of the catheter shaft 12). The balloon
15 includes a polymeric material having a surface 20 with a first
therapeutic agent disposed thereon (as a result of the therapeutic
agent being coated on the surface or impregnated into the polymeric
material). The balloon catheter also includes an elastomeric sheath
22 including an elastomeric material having a surface 24 with a
second therapeutic agent disposed thereon (as a result of the
therapeutic agent being coated on the surface or impregnated into
the elastomeric material). It is noted that although the
elastomeric sheath 22 runs along the whole length of the catheter
to allow it to be retrieved proximally, the whole length of the
elastomeric sheath does not necessarily have the second therapeutic
agent disposed thereon (hatched region of sheath 22 indicates that
portion of the sheath with therapeutic agent disposed thereon), but
only the distal portion thereof, in correspondence of the
balloon.
[0030] In certain embodiments of the present disclosure, as shown
in FIG. 2, the balloon catheter 10 includes an optional protective
sheath 26 positioned around the elastomeric sheath 22, which is
positioned around the balloon 15.
[0031] As shown in FIG. 3, in a first configuration (FIG. 3A) the
protective sheath 26 has been retracted proximally and the
inflatable balloon 15 (as shown in a folded state) is located
within the elastomeric sheath 22 such that expansion of the
inflatable balloon 15 to an inflated state (preferably, a first
inflated state) expands the elastomeric sheath 22 (as shown in FIG.
3B). In a second configuration (FIG. 3C) the elastomeric sheath 22
has been retracted proximally and the inflatable balloon 15 is
located outside of the elastomeric sheath (preferably, for
expansion to a second inflated state), the balloon 15 and the
elastomeric sheath 22 being configured for movement relative to
each other along the longitudinal axis 18 (see FIG. 1) between the
first configuration (FIG. 3A) and the second configuration (FIG.
3C) when deployed within a body lumen.
[0032] In certain embodiments of the present disclosure, as shown
in FIG. 2, the balloon catheter 10 includes a protective sheath 26
positioned around the elastomeric sheath 22. The protective sheath
26 is configured for movement relative to the elastomeric sheath 22
along the longitudinal axis 18, when deployed in a body lumen,
between a first configuration (FIG. 2) in which the elastomeric
sheath 22 is positioned within the protective sheath 26 and a
second configuration (FIGS. 3A-3C) in which at least a portion of
the elastomeric sheath 22 is located outside of the protective
sheath 26.
[0033] The balloon 15 of the balloon catheter 10 may be any of a
variety of conventional balloons for use in balloon catheters. They
may be of any of a variety of lengths, diameters, thicknesses,
etc., as is needed for the particular use. Typically, the length of
the balloon is selected such that the diseased vessel includes a
vascular lesion having a length that is longer than the balloon
length. The balloon may be compliant, semi-compliant, or
non-compliant. Semi-compliant and non-compliant balloons are most
useful for peripheral indications. An exemplary material for the
balloon is any of a wide variety of grades of nylon nylon-12). The
balloon may be made of a variety of other conventional polymeric
materials, such as polyethylene terephthalate (PET), polyethylene
(PE), high density polyethylene (HDPE), polyamide copolymers,
polyurethanes, polyvinyl chloride, blends, copolymers, and
multi-layered combinations thereof.
[0034] Typically, the elastomeric sheath 22 portion that is loaded
with the therapeutic agent (hatched region of sheath 22) is longer
than the balloon 15 (FIG. 1). In some embodiments, the elastomeric
sheath 22 portion that is loaded with the therapeutic agent
(hatched region of sheath 22) is positioned around the balloon 15
and at least a portion of the catheter shaft 12 close to the
balloon proximal end. The wall thickness of the elastomeric sheath
may be 0.001 inch, for example. The elastomeric sheath may be made
of a variety of elastomeric materials. Herein, an elastomeric
material is a polymeric material that resembles rubber because it
generally resumes its original shape when a deforming force is
removed. An exemplary material for the elastomeric sheath is
polytetrafluoroethylene (PTFE). The elastomeric sheath may be made
of a variety of other elastomeric materials, such as polyamides,
polyurethanes, polyvinyl chloride, blends, copolymers, and
multi-layered combinations thereof.
[0035] Typically, the optional protective sheath 26 is at least as
long as the elastomeric sheath 22 (FIG. 2). The wall thickness of
the protective sheath may be 0.001 inch, for example, or thicker.
The protective sheath may be made of the same material as the
elastomeric sheath, although this is not a requirement. The
protective sheath may be made of a variety of other polymeric
materials, such as polyethylene (PE) and high density polyethylene
(HDPE). Blends, copolymers, and multi-layered combinations of such
materials may be used in the protective sheath.
[0036] The therapeutic agent may be any of a variety of therapeutic
agents. Typically, these include agents for treating heart disease,
various cardiovascular ailments, and other vascular conditions,
including blockages, occlusions, stenoses or diseased regions in
the coronary artery, femoral artery, peripheral arteries, and other
arteries in the body. Treatment of vascular conditions may include
the prevention or correction of various ailments and deficiencies
associated with the cardiovascular system, the cerebrovascular
system, urinogenital systems, biliary conduits, abdominal
passageways and other biological vessels within the body.
[0037] Preferred therapeutic agents are those capable of producing
a beneficial effect against one or more conditions including
coronary restenosis, cardiovascular restenosis, angiographic
restenosis, arteriosclerosis, hyperplasia, and other diseases or
conditions. For example, the therapeutic agent may be selected to
inhibit or prevent vascular restenosis, a condition corresponding
to a narrowing or constriction of the diameter of the bodily lumen
where a stent is placed. An antirestenotic drug such as rapamycin,
a rapamycin analogue, or a rapamycin derivative may be used to
prevent or reduce the recurrence or narrowing and blockage of the
bodily vessel. Another preferred therapeutic agent is the
antirestenotic drug paclitaxel.
[0038] Alternatively, the therapeutic agent may be an anti-cancer
drug such as camptothecin or other topoisomerase inhibitors, an
antisense agent, an antineoplastic agent, an antiproliferative
agent, an antithrombogenic agent, an anticoagulant, an antiplatelet
agent, an antibiotic, an anti-inflammatory agent, a steroid, a gene
therapy agent, a recombinant DNA product, a recombinant RNA
product, an antisense compound, a collagen, a collagenic
derivative, a protein, a protein analog, a saccharide, a saccharide
derivative, a bioactive agent, other pharmaceutical drugs, or a
combination thereof.
[0039] The first and second therapeutic agents may be the same or
different therapeutic agents and/or they may be at different
concentrations. Two different therapeutic agents may be used, e.g.,
to fight different events that lead to restenosis (e.g., smooth
muscle cell migration and fibrin deposition).
[0040] The amount of the therapeutic agent applied to the balloon
and elastomeric sheath may vary depending on the characteristics of
the particular agent or combination of agents, the length of time
the balloon or elastomeric sheath is in place and other factors.
Generally, the dose of therapeutic agent disposed on a balloon or
elastomeric sheath of the present disclosure ranges from nanograms
to milligrams. In one embodiment, the therapeutic agent is coated
to achieve a total amount disposed on the surface of the balloon or
elastomeric sheath of at least 1 microgram per square millimeter (1
.mu.g/mm.sup.2). In another embodiment, the amount disposed on the
surface of the balloon or elastomeric sheath is up to 1000
micrograms per square millimeter (.mu.g/mm.sup.2). Typically the
therapeutic agent is coated to achieve a total amount disposed on
the surface of the balloon or elastomeric sheath in a range from
about 1 .mu.g/mm.sup.2 to about 5 .mu.g/mm.sup.2.
[0041] The therapeutic agent may be disposed on, and preferably
adhered to, the balloon and elastomeric sheath with or without the
use of any binding agents, e.g., polymeric binders. If binding
agents are used, examples of such agents include, for example,
urea, azides, gels, biodegradable/bioabsorbable polymers.
Methods of Making
[0042] The therapeutic agent may be applied to the balloon and
elastomeric sheath using a variety of coating or impregnating
techniques, for example. Balloons and elastomeric sheaths can be
coated with a therapeutic agent (e.g., drug) coating solution by
application techniques such as dipping, spraying, painting, and
brushing (e.g., U.S. Pat. Nos. 8,257,305 and 7,750,041; and
International Pub. No. WO 2009/018816). In many of the current
balloon coating methods, a coating solution that includes at least
one therapeuting agent and a solvent is applied to a balloon to
form a substantially uniform layer of therapeutic agent. The
concentration of the therapeutic agent applied to the balloon and
elastomeric sheath of the present disclosure varies depending on
the therapeutic agent intended use.
[0043] In one embodiment, there is provided a method of
manufacturing a balloon catheter as described herein using a
delivery sheath. Such method is analogous to the method described
in U.S. Pat. No. 7,704,545 for applying a drug to a stent. In
various embodiments, the delivery sheath is coated with a
therapeutic agent (and a polymer). In certain embodiments, the
delivery sheath can be impregnated with a therapeutic agent.
[0044] The delivery sheath may be made of a flexible material
suitable for positioning around the balloon. in one embodiment, the
delivery sheath is a polymer. The polymer may be, for example,
poly(ethylene-vinyl acetate) (PEVA), polyurethane,
polycaprolactone, phosphoryl choline, a blended polymer of
polyurethane and polycaprolactone or any other polymer well known
to those with skill in the art.
[0045] This method of manufacturing includes: providing an
elongated catheter shaft having proximal and distal ends with an
inflatable balloon located close to the distal end of the catheter
shaft, wherein the balloon includes a polymeric material having a
surface; positioning a (first) delivery sheath around the balloon,
wherein the delivery sheath includes a polymeric material having a
therapeutic agent impregnated therein or coated thereon; and
applying conditions effective to transfer (e.g., diffuse) the
therapeutic agent from the delivery sheath to the surface of the
inflatable balloon.
[0046] In another embodiment of manufacturing a balloon cather as
described herein, the method further includes: removing the
delivery sheath from the balloon; positioning an elastomeric sheath
around the balloon, wherein the elastomeric sheath includes an
elastomeric material having a surface; positioning a (second)
delivery sheath around the elastomeric sheath, wherein the delivery
sheath includes a polymeric material having a therapeutic agent
impregnated therein or coated thereon; and applying conditions
effective to tansfer (e.g., diffuse) the therapeutic agent from the
delivery sheath to the surface of the elastomeric sheath.
[0047] In operation, the delivery sheath is wrapped or otherwise
placed around the balloon or elastomeric sheath (advantageously the
elastomeric sheath can be mounted on a mandrel assembly) so that
the delivery sheath contacts the surface of the balloon or the
surface of the elastomeric sheath. In this position, the
therapeutic agent will be transferred (e.g., diffused) to the
balloon or elastomeric sheath. The transfer of the therapeutic
agent will continue until a state of equilibrium is reached or
until the delivery sheath is removed from contact with the balloon
or elastomeric sheath.
[0048] The application conditions effective to trasfer the
therapeutic agent from the delivery sheath to the surface of the
balloon or elastomeric sheath include elevated temperatures and
pressures (typically above room temperature). The higher these
parameters, the faster the rate of transfer (e.g., diffusion). The
maximum values would likely be those that damage the materials of
the balloon, elastomeric sheath, and delivery sheath. For example,
the temperature and pressure for transferring from a delivery
sheath to a balloon made of Nylon-12 would be no greater than its
melting temperature (190.degree. C.-210.degree. C. at ambient
pressure), and preferably no greater than its heat distortion
temperature, which is 150.degree. C. at 0.45 MPa and 55.degree. C.
at 1.80 MPa.
[0049] Those of skill in the art will recognize that the method of
loading the therapeutic agent disclosed herein using a delivery
sheath allows for precise control of the amount loaded as well as
allows for the loading of amounts below that allowed by current
methods of application such as, for example, dipping, spraying, and
brushing.
Methods of Use
[0050] In one embodiment of the present disclosure, there is
provided a method of delivering one or more therapeutic agents to a
diseased vessel.
[0051] Referring to FIG. 3, an exemplary general method includes:
providing a balloon catheter 10 as described herein; advancing the
balloon catheter 10 into the diseased vessel 30 (as shown in FIG.
3A); inflating the inflatable balloon to form an inflated balloon
15 and an expanded sheath 22 that contacts the wall of the diseased
vessel 30 and thereby delivers the second therapeutic agent from
the surface of the expanded sheath to a first site of the diseased
vessel (as shown in FIG. 3B); deflating the inflated balloon to
reform the inflatable balloon into a reformed inflatable balloon
(not shown); removing the elastomeric sheath from around the
reformed inflatable balloon (not shown); and inflating the reformed
inflatable balloon (after removing the elastomeric sheath) to
contact the wall of the diseased vessel 30 with the first
therapeutic agent to deliver the first therapeutic agent from the
surface of the inflated balloon 15 to the first site (as shown in
FIG. 3C), or to a different site of the same or a different
diseased vessel if the reformed inflatable balloon is moved to a
different site after the expanded sheath contacts the wall of the
diseased vessel and before inflating the reformed inflatable
balloon.
[0052] Referring to FIG. 3A, a preferred method includes: providing
a balloon catheter 10 that includes: an elongated catheter shaft 12
having a proximal end 14 and a distal end 16; a folded inflatable
balloon 15 located close to the distal end 16 of the catheter shaft
12, wherein the balloon includes a polymeric material having a
surface with a first therapeutic agent disposed thereon (as a
result of the therapeutic agent being coated on the surface or
impregnated into the polymeric material); and an elastomeric sheath
22 positioned around the folded inflatable balloon such that the
inflatable balloon is located within the elastomeric sheath,
wherein the sheath includes an elastomeric material having a
surface with a second therapeutic agent disposed thereon (as a
result of the therapeutic agent being coated on the surface or
impregnated into the elastomeric material). The method further
includes: advancing the balloon catheter 10 into the diseased
vessel 30 (i.e., one having a vascular lesion); and (referring to
FIG. 3B) inflating the inflatable balloon to form an inflated
balloon 15 and an expanded sheath 22 that contacts the wall of the
diseased vessel 30 and thereby delivers the second therapeutic
agent from the surface of the expanded sheath to a first site of
the diseased vessel. The method then includes deflating the
inflated balloon after delivering the second therapeutic agent to
the first site to reform the inflatable balloon into a reformed
inflatable balloon (herein, a "reformed" inflatable balloon may or
may not be refolded, and may or may not be the same degree of
"deflation" of the initial inflatable balloon) (not shown);
removing the elastomeric sheath 22 from around the reformed
inflatable balloon (e.g., to a position shown in FIG. 3C); and (as
shown in FIG. 3C) inflating the reformed inflatable balloon (after
removing the elastomeric sheath) from the reformed inflatable
balloon to contact the watt of the diseased vessel with the first
therapeutic agent to deliver the first therapeutic agent from the
surface of the inflated reformed inflatable balloon to the first
site, or to a different site of the same or a different diseased
vessel if the reformed inflatable balloon is moved to the different
site after the expanded sheath contacts the wall of the diseased
vessel and before inflating the reformed inflatable balloon.
Folding, and thus also refolding, may be not necessary in case
spherical balloons are used. These are typically quite small
balloons (e.g., having outside diameter of about 1 mm).
[0053] In certain preferred methods, the balloon catheter further
includes a protective sheath positioned around the elastomeric
sheath and the inflatable balloon located in the elastomeric
sheath, and the method further includes (as shown in FIG. 3A)
removing the protective sheath 26 from the elastomeric sheath 22
after advancing the balloon catheter 10 into the diseased vessel
30.
[0054] In certain preferred methods, removing the elastomeric
sheath from around the reformed inflatable balloon includes
retracting the elastomeric sheath 22 towards the proximal end 14 of
the catheter shaft 12 (as shown in FIG. 3A). This allows the
balloon to stay at the same site of initial treatment or be
advanced to a second, more distal site. Alternatively, removing the
elastomeric sheath from around the reformed inflatable balloon
includes advancing the reformed inflatable balloon to a second site
of the diseased vessel that is distal from the first site.
[0055] In certain preferred methods, particularly those in which
the therapeutic agent-coated portion of the elastomeric sheath is
longer than the inflatable balloon, after inflating the inflatable
balloon to form the inflated balloon and the expanded sheath and
prior to removing the elastomeric sheath from around the reformed
inflatable balloon, the method includes: retracting the inflatable
balloon proximally towards the proximal end of the catheter shaft
within the elastomeric sheath; inflating the inflatable balloon
after retracting the inflatable balloon proximally so that the
elastomeric sheath contacts the wall of the diseased vessel and
thereby delivers the second therapeutic agent to a second site that
is located proximally from the first site of the diseased vessel;
and deflating the inflated balloon after delivering the second
therapeutic agent at the second site (to again reform an inflatable
balloon, wherein a "reformed" inflatable balloon may or may not be
refolded, and may or may not be the same degree of "deflation" of
the initial inflatable balloon or the "first reformed" inflatable
balloon).
[0056] Referring to FIG. 4, in one embodiment of the present
disclosure, there is provided an alternative method of delivering
one or more therapeutic agents to a diseased vessel. The method
includes: (referring to FIG. 4A) providing a balloon catheter 10
that includes: an elongated catheter shaft 12 having a proximal end
14 and a distal end 16; an inflatable balloon 15 (preferably, a
folded inflatable balloon) located close to the distal end 16 of
the catheter shaft 12 (i.e., closer to the distal end 16 of the
catheter shaft 12 than the proximal end 14 of the catheter shaft
12), wherein the balloon has a proximal end 14' and a distal end
16', and wherein the balloon comprises a polymeric material having
a surface with a first therapeutic agent disposed thereon (as a
result of the therapeutic agent being coated on the surface or
impregnated into the polymeric material); an elastomeric sheath 22
positioned around the inflatable balloon 15 such that the
inflatable balloon is located within the elastomeric sheath,
wherein the sheath comprises an elastomeric material having a
surface with a second therapeutic agent disposed thereon (as a
result of the therapeutic agent being coated on the surface or
impregnated into the elastomeric material), and wherein the
therapeutic agent-coated portion of the elastomeric sheath (hatched
portion of sheath 22) is longer than the inflatable balloon; and a
protective sheath 26 positioned around the elastomeric sheath 22
and the inflatable balloon 15.
[0057] In a first delivery step, the method further includes:
advancing the balloon catheter 10 into the diseased vessel 30 (to a
lesion to be treated); and (as shown in FIG. 4B) retracting the
protective sheath 26 towards the proximal end 14 of the catheter
shaft 12 so that the inflatable balloon 15 is not located in the
protective sheath 26; inflating the inflatable balloon to form an
inflated balloon and an expanded sheath that contacts the wall of
the diseased vessel and thereby delivers the second therapeutic
agent from the surface of the expanded sheath to a first site 32 of
the diseased vessel 30. The inflated balloon is then deflated after
delivering the second therapeutic agent to the first site to reform
the inflatable balloon into a reformed inflatable balloon (herein,
this "first reformed" inflatable balloon may or may not be
refolded, and may or may not be the same degree of "deflation" of
the initial inflatable balloon).
[0058] In a second delivery step, as shown in FIG. 4C, the method
then includes retracting the protective sheath 26 proximally
towards the proximal end 14 of the catheter shaft 12 so that the
reformed inflatable balloon is not located in the protective sheath
26 after delivering the second therapeutic agent to the first site
32; retracting the reformed inflatable balloon 15 proximally
towards the proximal end 14 of the catheter shaft 12 within the
elastomeric sheath 22 after delivering the second therapeutic agent
to the first site 32; and inflating the reformed inflatable balloon
after retracting the reformed inflatable balloon and the protective
sheath proximally so that the elastomeric sheath contacts the wall
of the diseased vessel and thereby delivers the second therapeutic
agent to a second site 34 that is located proximally from the first
site of the diseased vessel. In FIG. 4C the second site 34 is shown
adjacent to the first site 32. The (reformed) inflated balloon is
deflated once again to reform the inflatable balloon (into a
reformed inflatable balloon) after delivering the second
therapeutic agent to the second site (herein, a "second reformed"
inflatable balloon may or may not be refolded, and may or may not
be the same degree of "deflation" of the initial inflatable balloon
or the "first reformed" inflatable balloon).
[0059] In a third delivery step, as shown in FIG. 4D, the method
then includes retracting the elastomeric sheath 22 proximally
towards the proximal end 14 of the catheter shaft 12 so that the
reformed inflatable balloon 15 is not located in the protective
sheath or the elastomeric sheath after delivering the second
therapeutic agent to the second site 34; and inflating the reformed
inflatable balloon 15 after retracting the elastomeric sheath 22
proximally to form an inflated balloon that contacts the wall of
the diseased vessel and thereby delivers the first therapeutic
agent from the surface of the inflated balloon to the second site
34 of the diseased vessel, or to a third site of the diseased
vessel if the inflated balloon is moved to a different site after
delivering the second therapeutic agent to the second site.
[0060] Using this method, a therapeutic agent may be delivered
multiple times to various sites from the elastomeric sheath,
although typically only once from the balloon.
[0061] In certain embodiments, the present disclosure may be
particularly advantageous in case long or very long lesions are to
be treated. In fact, because the therapeutic agent may be present
both on the balloon and on at least a portion of the elastomeric
sheath, only one catheter device may need to be used for treating
lesions having a length equal to or lower than the sum of the
coated balloon length and the coated elastomeric sheath length. In
other words, because of the present disclosure it is not necessary
to use two, or more than two, therapeutic agent-coated balloon
catheters for treating a long or very long lesion, but only a
single balloon catheter may be sufficient for achieving the same
result. This clearly means saving of intervention time (since only
one device has to be introduced into the blood vessel, tracked to
the lesion and operated by the physician) as well as saving of
money (since only one device may need to be used).
[0062] Moreover, even in the case the lesion to be treated is not
remarkably long, the present disclosure may represent an
advantageous solution with respect to the known devices since the
balloon length may be selected to be sensibly lower than the lesion
length due to the therapeutic agent-coated elastomeric sheath
length, and thus may be used to treat the lesion in combination
with the therapeutic agent coated balloon. This aspect is
particularly favorable because manufacturing and coating a short
balloon is easier and less expensive than manufacturing and coating
a long or very long (up to 300 mm length) balloon.
Exemplary Embodiments
[0063] Embodiment 1 is a balloon catheter comprising: an elongated
catheter shaft having proximal and distal ends, wherein the
catheter shaft defines a longitudinal axis extending between the
proximal and distal ends; an inflatable balloon located closer to
the distal end of the catheter shaft than the proximal end of the
catheter shaft, wherein the balloon comprises a polymeric material
having a surface with a first therapeutic agent disposed thereon
(as a result of the therapeutic agent being coated on the surface
or impregnated into the polymeric material); and an elastomeric
sheath comprising an elastomeric material having a surface with a
second therapeutic agent disposed thereon (as a result of the
therapeutic agent being coated on the surface or impregnated into
the elastomeric material); wherein in a first configuration the
inflatable balloon is located within the elastomeric sheath such
that expansion of the inflatable balloon to an inflated state
expands the elastomeric sheath, and wherein in a second
configuration the balloon is located outside of the elastomeric
sheath, and further wherein the balloon and the sheath are
configured for movement relative to each other along the
longitudinal axis between the first configuration and the second
configuration when deployed within a body lumen.
[0064] Embodiment 2 is the balloon catheter of embodiment 1 wherein
the inflatable balloon is in a folded state when in the first
configuration.
[0065] Embodiment 3 is the balloon catheter of embodiments 1 or 2
wherein the first and second therapeutic agents are different
therapeutic agents.
[0066] Embodiment 4 is the balloon catheter of embodiments 1 or 2
wherein the first and second therapeutic agents are the same
therapeutic agent.
[0067] Embodiment 5 is the balloon catheter of any of embodiments 1
through 4 wherein the first and second therapeutic agents are at
different concentrations.
[0068] Embodiment 6 is the balloon catheter of any of embodiments 1
through 4 wherein the first and second therapeutic agents are at
the same concentrations.
[0069] Embodiment 7 is the balloon catheter of any of embodiments 1
through 6 wherein the elastomeric material of the elastomeric
sheath comprises polytetrafluoroethylene.
[0070] Embodiment 8 is the balloon catheter of any of embodiments
it through wherein the polymeric material of the balloon comprises
a nylon or a polyethylene terephthalate.
[0071] Embodiment 9 is the balloon catheter of embodiments 1
through 8 further comprising an optional protective sheath
positioned around the elastomeric sheath, wherein the protective
sheath is configured for movement relative to the elastomeric
sheath along the longitudinal axis, when deployed in a body lumen,
between a first configuration in which the elastomeric sheath is
positioned within the protective sheath and a second configuration
in which at least a portion of the elastomeric sheath is located
outside of the protective sheath.
[0072] Embodiment 10 is a method of manufacturing the balloon
catheter of any of embodiments 1 through 9, the method comprising:
[0073] providing an elongated catheter shaft having proximal and
distal ends with an inflatable balloon located closer to the distal
end of the catheter shaft than the proximal end of the catheter
shaft, wherein the balloon comprises a polymeric material having a
surface; [0074] positioning a delivery sheath around the balloon,
wherein the delivery sheath comprises a polymeric material having a
therapeutic agent impregnated therein or coated thereon; and [0075]
applying conditions effective to transfer (e.g., diffuse) the
therapeutic agent from the delivery sheath to the surface of the
inflatable balloon.
[0076] Embodiment 11 is the method of embodiment 10 further
comprising: removing the delivery sheath from the balloon;
positioning an elastomeric sheath around the balloon, wherein the
elastomeric sheath comprises an elastomeric material having a
surface; positioning a delivery sheath around the elastomeric
sheath, wherein the delivery sheath comprises a polymeric material
having a therapeutic agent impregnated therein or coated thereon;
and applying conditions effective to transfer (e.g., diffuse) the
therapeutic agent from the delivery sheath to the surface of the
elastomeric sheath.
[0077] Embodiment 12 is a method of delivering one or more
therapeutic agents to a diseased vessel, the method comprising:
providing a balloon catheter of any of embodiments 1 through 9;
advancing the balloon catheter into the diseased vessel; inflating
the inflatable balloon to form an inflated balloon and an expanded
sheath that contacts the wall of the diseased vessel and thereby
delivers the second therapeutic agent from the surface of the
expanded sheath to a first site of the diseased vessel; deflating
the inflated balloon to reform the inflatable balloon into a
reformed inflatable balloon ("reformed" inflatable balloon may or
may not be refolded, and may or may not be the same degree of
"deflation" of the initial inflatable balloon); removing the
elastomeric sheath from around the reformed inflatable balloon; and
inflating the reformed inflatable balloon to contact the wall of
the diseased vessel with the first therapeutic agent to deliver the
first therapeutic agent from the surface of the inflated balloon to
the first site, or to a different site of the same or a different
diseased vessel if the reformed inflatable balloon is moved to the
different site after the expanded sheath contacts the wall of the
diseased vessel and before inflating the reformed inflatable
balloon.
[0078] Embodiment 13 is a method of delivering one or more
therapeutic agents to a diseased vessel, the method comprising:
[0079] providing a balloon catheter comprising: [0080] an elongated
catheter shaft having proximal and distal ends; [0081] a folded
inflatable balloon located closer to the distal end of the catheter
shaft than the proximal end of the catheter shaft, wherein the
balloon comprises a polymeric material having a surface with a
first therapeutic agent disposed thereon (as a result of the
therapeutic agent being coated on the surface or impregnated into
the polymeric material); and [0082] an elastomeric sheath
positioned around the folded inflatable balloon such that the
inflatable balloon is located within the elastomeric sheath,
wherein the sheath comprises an elastomeric material having a
surface with a second therapeutic agent disposed thereon (as a
result of the therapeutic agent being coated on the surface or
impregnated into the elastomeric material); [0083] advancing the
balloon catheter into the diseased vessel; [0084] inflating the
folded inflatable balloon to form an inflated balloon and an
expanded sheath that contacts the wail of the diseased vessel and
thereby delivers the second. therapeutic agent from the surface of
the expanded sheath to a first site of the diseased vessel; [0085]
deflating the inflated balloon after delivering the second
therapeutic agent to the first site to reform the inflatable
balloon into a reformed inflatable balloon ("reformed" inflatable
balloon may or may not be refolded, and may or may not be the same
degree of "deflation" of the initial inflatable balloon); [0086]
removing the elastomeric sheath from around the reformed inflatable
balloon; and [0087] inflating the reformed inflatable balloon to
contact the wall of the diseased vessel with the first therapeutic
agent to deliver the first therapeutic agent from the surface of
the inflated reformed inflatable balloon to the first site, or to a
different site of the same or a different diseased vessel if the
reformed inflatable balloon is moved to the different site after
the expanded sheath contacts the wall of the diseased vessel and
before inflating the reformed inflatable balloon.
[0088] Embodiment 14 is the method of embodiment 13 wherein the
balloon catheter further comprises a protective. sheath positioned
around the elastomeric sheath and the inflatable balloon located in
the elastomeric sheath, and the method further comprises removing
the protective sheath from the elastomeric sheath after advancing
the balloon catheter into the diseased vessel.
[0089] Embodiment 15 is the method of embodiment 13 or 14 wherein
the diseased vessel comprises a vascular lesion having a length
that is longer than the length of the balloon.
[0090] Embodiment 16 is the method of any of embodiments 12 through
15 wherein removing the elastomeric sheath from around the reformed
inflatable balloon comprises retracting the sheath towards the
proximal end of the catheter shaft (so the balloon can stay at the
same site of initial treatment or be advanced to a second, more
distal site).
[0091] Embodiment 17 is the method of any of embodiments 12 through
16 wherein removing the elastomeric sheath from around the reformed
inflatable balloon comprises advancing the reformed inflatable
balloon to a second site of the diseased vessel that is distal from
the first site.
[0092] Embodiment 18 is the method of any of embodiments 12 through
17 wherein the elastomeric sheath is longer than the inflatable
balloon; and wherein after inflating the inflatable balloon to form
the inflated balloon and the expanded sheath and prior to removing
the elastomeric sheath from around the reformed inflatable balloon,
the method comprises: retracting the inflatable balloon proximally
towards the proximal end of the catheter shaft within the
elastomeric sheath; inflating the inflatable balloon after
retracting the inflatable balloon proximally so that the
elastomeric sheath contacts the wall of the diseased vessel and
thereby delivers the second therapeutic agent to a second site that
is located proximally from the first site of the diseased vessel;
and deflating the inflated balloon after delivering the second
therapeutic agent at the second site.
[0093] Embodiment 19 is a method of delivering one or more
therapeutic agents to a diseased vessel, the method comprising:
[0094] providing a balloon catheter comprising: [0095] an elongated
catheter shaft having proximal and distal ends; [0096] an
inflatable balloon located closer to the distal end of the catheter
shaft than the proximal end of the catheter shaft, wherein the
balloon has a proximal end and a distal end, and wherein the
balloon comprises a polymeric material having a surface with a
first therapeutic agent disposed thereon (as a result of the
therapeutic agent being coated on the surface or impregnated into
the polymeric material); [0097] an elastomeric sheath positioned
around the inflatable balloon such that the inflatable balloon is
located within the elastomeric sheath, wherein the sheath comprises
an elastomeric material having a surface with a second therapeutic
agent disposed thereon (as a result of the therapeutic agent being
coated on the surface or impregnated into the elastomeric
material), and wherein the elastomeric sheath is longer than the
inflatable balloon; and [0098] a protective sheath positioned
around the elastomeric sheath and the inflatable balloon; [0099]
advancing the balloon catheter into the diseased vessel; [0100]
retracting the protective sheath towards the proximal end of the
catheter shaft so that the inflatable balloon is not located in the
protective sheath; [0101] inflating the inflatable balloon to form
an inflated balloon and an expanded sheath that contacts the wall
of the diseased vessel and thereby delivers the second therapeutic
agent from the surface of the expanded sheath to a first site of
the diseased vessel; [0102] deflating the inflated balloon after
delivering the second therapeutic agent to the first site to reform
the inflatable balloon into a reformed inflatable balloon (this
"first reformed" inflatable balloon may or may not be refolded, and
may or may not be the same degree of "deflation" of the initial
inflatable balloon); [0103] retracting the protective sheath
proximally towards the proximal end of the catheter shaft so that
the reformed inflatable balloon is not located in the protective
sheath after delivering the second therapeutic agent to the first
site; [0104] retracting the reformed inflatable balloon proximally
towards the proximal end of the catheter shaft within the
elastomeric sheath (after delivering the second therapeutic agent
to the first site); [0105] inflating the reformed inflatable
balloon (after retracting the inflatable balloon and the protective
sheath proximally) so that the elastomeric sheath contacts the wall
of the diseased vessel and thereby delivers the second therapeutic
agent to a second site that is located proximally from the first
site of the diseased vessel; [0106] deflating the reformed inflated
balloon to again reform a reformed inflatable balloon after
delivering the second therapeutic agent to the second site (to form
a second reformed inflatable balloon, wherein this "second
reformed" inflatable balloon may or may not be refolded, and may or
may not be the same degree of "deflation" of the initial or "first
reformed" inflatable balloon); [0107] retracting the elastomeric
sheath proximally towards the proximal end of the catheter shaft so
that the reformed inflatable balloon is not located in the
protective sheath or the elastomeric sheath after delivering the
second therapeutic agent to the second site; and [0108] inflating
the reformed inflatable balloon (after retracting the elastomeric
sheath proximally) to form an inflated balloon that contacts the
wall of the diseased vessel and thereby delivers the first
therapeutic agent from the surface of the inflated balloon to the
second site of the diseased vessel, or to a third site of the
diseased vessel if the inflated balloon is moved to the different
site after delivering the second therapeutic agent to the second
site.
[0109] The complete disclosures of the patents, patent documents,
and publications cited herein are incorporated by reference in
their entirety as if each were individually incorporated. Various
modifications and alterations to this disclosure will become
apparent to those skilled in the art without departing from the
scope and spirit of this disclosure. it should be understood that
this disclosure is not intended to be unduly limited by the
illustrative embodiments and examples set forth herein and that
such examples and embodiments are presented by way of example only
with the scope of the disclosure intended to be limited only by the
claims set forth herein as follows.
* * * * *