U.S. patent application number 14/548707 was filed with the patent office on 2015-03-19 for systems and methods for introducing and applying a bandage structure within a body lumen or hollow body organ.
The applicant listed for this patent is Providence Health System - Oregon d/b/a Providence St. Vincent Medical Center, Providence Health System - Oregon d/b/a Providence St. Vincent Medical Center. Invention is credited to Amanda Dayton (formerly Senrud), Kenton W. Gregory.
Application Number | 20150080659 14/548707 |
Document ID | / |
Family ID | 38779196 |
Filed Date | 2015-03-19 |
United States Patent
Application |
20150080659 |
Kind Code |
A1 |
Gregory; Kenton W. ; et
al. |
March 19, 2015 |
Systems and Methods for Introducing and Applying a Bandage
Structure Within a Body Lumen or Hollow Body Organ
Abstract
Systems and methods provide intraluminal delivery of a bandage
structure within a body lumen or hollow body organ, e.g., for
treating an injured gastrointestinal tract or an esophageal
hemorrhage in a non-invasive way using endoscopic visualization.
The systems and methods can be sized and configured to apply a
chitosan bandage structure within a body lumen or hollow body
organ, to take advantage of the mucoadhesive, antimicrobial,
hemostatic, and potential accelerated wound healing properties of
the chitosan material.
Inventors: |
Gregory; Kenton W.;
(Portland, OR) ; Dayton (formerly Senrud); Amanda;
(Portland, OR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Providence Health System - Oregon d/b/a Providence St. Vincent
Medical Center |
Portland |
OR |
US |
|
|
Family ID: |
38779196 |
Appl. No.: |
14/548707 |
Filed: |
November 20, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12004297 |
Dec 20, 2007 |
8920514 |
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14548707 |
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11805543 |
May 23, 2007 |
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12004297 |
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60802654 |
May 23, 2006 |
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Current U.S.
Class: |
600/153 ; 602/54;
604/516; 604/57 |
Current CPC
Class: |
A61F 2013/00357
20130101; A61L 15/28 20130101; A61F 2/04 20130101; A61L 15/28
20130101; A61F 15/005 20130101; A61F 2/958 20130101; A61B 1/273
20130101; A61F 2/962 20130101; C08L 5/08 20130101; A61F 13/0253
20130101 |
Class at
Publication: |
600/153 ; 604/57;
602/54; 604/516 |
International
Class: |
A61F 15/00 20060101
A61F015/00; A61F 13/02 20060101 A61F013/02; A61B 1/273 20060101
A61B001/273 |
Claims
1. An intraluminal or hollow body organ bandage structure delivery
system comprising: a rolled chitosan bandage having a tab and a
slit located on an outer surface, wherein the tab is slidably
inserted into the slit to hold the bandage in a rolled position; an
expandable structure supporting the bandage; and a removable sheath
enclosing the bandage.
2. The delivery system of claim 1, wherein the outer surface of the
bandage provides an active surface that reacts in the presence of
body fluid to become adhesive.
3. The delivery system of claim 1, wherein the inner surface of the
bandage provides a non-stick coating.
4. The delivery system of claim 3, wherein the inner surface of the
bandage is water impermeable.
5. The delivery system of claim 1, wherein the removable sheath
includes a releasable securing device.
6. The delivery system of claim 1, further comprising a multi-lumen
catheter tube.
7. The delivery system of claim 1, further comprising endoscopic
visualization.
8. The delivery system of claim 1, further comprising a guide
wire.
9. A rolled chitosan bandage structure sized and configured to be
deployed within a body lumen or hollow body organ, wherein said
structure comprises on a first side an outer surface comprising
chitosan and including a tab and a slit formed therein and, on a
second opposite side, a non-stick coating.
10. The rolled chitosan bandage of claim 9, wherein the tab is
slidably inserted into the slit.
11. The rolled chitosan bandage of claim 9, wherein the non-stick
coating on the second opposite side of said structure is water
impermeable.
12. A method for delivery of a bandage structure within a body
lumen or hollow body organ, comprising: providing the delivery
system of claim 1; positioning the delivery system within the body
lumen or hollow body organ and relative to an injury site; and
adhering the bandage to the injury site.
13. The method of claim 12, further comprising: expanding the
expandable structure to apply pressure from within the bandage so
that the tab slides out of the slit and the bandage unfurls.
14. The method of claim 12, further comprising: removing the
expandable structure; and leaving the bandage adhered to the injury
site.
15. A delivery system for delivering a rolled chitosan bandage
structure sized and configured to be deployed within a body lumen
or hollow body organ, wherein said bandage structure comprises on a
first side an outer active chitosan surface and, on a second
opposite side, a non-stick coating, the delivery system comprising
a multi-lumen catheter tube having a proximal end and a distal end,
the catheter tube comprising an interior lumen through which a
guide wire is configured to pass, the distal end carrying an
expandable structure through which the interior lumen extends, the
bandage structure being carried about the expandable structure, and
the catheter tube further comprising a removable sheath.
16. The delivery system of claim 15, further comprising endoscopic
visualization.
17. The delivery system of claim 15, further comprising a push-pull
wire.
18. The delivery system of claim 15, wherein the expandable
structure is partially enlarged to create bulbous forms on each
side of the bandage structure.
19. The delivery system of claim 15, wherein the sheath has a
releasable securing device at the distal end.
20. The delivery system of claim 15, wherein the non-stick coating
of the second opposite side of said bandage structure is water
impermeable.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of copending patent
application Ser. No. 12/004,297, filed Dec. 20, 2007, which itself
is a continuation of patent application Ser. No. 11/805,543 filed
May 23, 2007, now abandoned, which claims the benefit of
provisional patent application Ser. No. 60/802,654 filed 23 May
2006.
[0002] This application is related to U.S. patent application Ser.
No. 11/084,688, filed on Mar. 17, 2005, entitled "Systems and
Methods for Hemorrhage Control and/or Tissue Repair."
FIELD OF THE INVENTION
[0003] The invention is generally directed to systems and methods
to introduce and deploy tissue bandage structures within a body
lumen or hollow body organ, such, e.g., as within the
gastrointestinal tract.
BACKGROUND OF THE INVENTION
[0004] Currently, there exists no overwhelmingly accepted treatment
for gastrointestinal, specifically esophageal bleeding with
etiology such as; esophageal ulcers, esophagitis, Mallory Weis
tears, Booerhave's syndrome, esophageal varices, anastornosis,
fistula, and endoscopic procedures.
[0005] Electro-cautery and sclerotherapy are two existing
treatments for esophageal hemorrhage; however both run a risk of
perforation to the esophagus. Electro-cautery requires a large
amount of pressure to be applied to the wall of the esophagus and
also inherently damages tissue. Sclerotherapy consists of injecting
a hardening agent in to the area of the injury with a needle.
Clipping is another method of treatment; it consists of a two or
three-pronged clip that can be inserted into the mucosa of the
esophagus to constrict the area of the bleeding. If applied
correctly, clipping is effective in controlling hemorrhage, however
clips are difficult to deploy. Often, the clip is not inserted deep
enough into the mucosa and sloughs off before the desired time.
SUMMARY OF THE INVENTION
[0006] The invention provides systems and methods for applying a
bandage structure within a body lumen or a hollow body organ, e.g.,
for treating an injured gastrointestinal tract or an esophageal
hemorrhage.
[0007] Another aspect of the invention includes systems and methods
for placing a bandage structure within a body lumen or hollow body
organ in a non-invasive way using endoscopic visualization.
[0008] The systems and methods do not involve the use of any sharp
edges or points. The systems and methods do not involve the use of
a point pressure, as existing treatment options require. Only
moderate circumferential pressure is required to apply the bandage
structure. The systems and methods adapt well to tools and
techniques usable by gastroenterologists.
[0009] The systems and methods can be sized and configured to apply
a chitosan bandage structure within a body lumen or hollow body
organ, to take advantage of the mucoadhesive, antimicrobial,
hemostatic, and potential accelerated wound healing properties of
the chitosan material. Drug delivery and cell therapy with a
chitosan bandage structure as a delivery matrix are also made
possible.
[0010] Other features and advantages of the invention shall be
apparent based upon the accompanying description, drawings, and
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a plane view of an intraluminal delivery system
for introducing and applying a bandage structure within a body
lumen or hollow body organ.
[0012] FIG. 2 is perspective view of the bandage structure that is
sized and configured for deployment by the system shown in FIG.
1.
[0013] FIGS. 3 to 5 show the rolling of the bandage structure into
a low profile condition prior to deployment by the system shown in
FIG. 1.
[0014] FIGS. 6 to 9 show the placement of a rolled bandage
structure upon the expandable delivery structure that forms a part
of the system shown in FIG. 1.
[0015] FIGS. 10 to 13 show the use of the delivery system shown in
FIG. 1 for introducing and applying a bandage structure within a
body lumen or hollow body organ.
[0016] FIG. 14 shows an optional over-tube that can be used in
association with the system shown in FIG. 1.
[0017] FIG. 15 shows the system shown in FIG. 1 hack-loaded into
the working channel of an endoscope.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0018] Although the disclosure hereof is detailed and exact to
enable those skilled in the art to practice the invention, the
physical embodiments herein disclosed merely exemplify the
invention, which may be embodied in other specific structure. While
the preferred embodiment has been described, the details may be
changed without departing from the invention, which is defined by
the claims.
I. The Intraluminal Delivery System
[0019] FIG. 1 shows an intraluminal delivery system 10 for
introducing and applying a bandage structure 12 within a body lumen
or hollow body organ. The delivery system 10 includes a bandage
structure 12 and a delivery device 14 that is sized and configured
to deliver and deploy the bandage structure 12 at a targeted tissue
region within a body lumen or hollow body organ. The delivery
device 14 is sized and configured to deploy the bandage structure
12 while preventing it from contacting tissue lining the body lumen
or hollow body organ until the desired time of deployment. The
delivery device 14 not only provides a barrier between the bandage
structure 12 and tissue within the body lumen or hollow body organ
during introduction, but also provides a means to deploy the
bandage structure 12 into contact with the tissue at the desired
time.
[0020] As shown in FIG. 1, the delivery device 14 can be sized and
configured to accommodate passage over a guide wire 32. In this
way, the delivery device 14 can be introduced over the guide wire
32 under direct visualization from an endoscope 50, as FIG. 10
shows. In this arrangement, the guide wire 32 runs next to the
endoscope 50 and therefore leaves the working channel of the
endoscope 50 free. In an alternative arrangement (see FIG. 15), the
delivery device 14 can be sized and configured to be back-loaded
through the working channel 52 of an endoscope 50. The working
channel 52 of the endoscope 50 thereby serves to guide the delivery
device 14 while providing direct visualization.
[0021] A. The Tissue Bandage Structure
[0022] The size, shape, and configuration of the bandage structure
12 shown in FIG. 1 can vary according to its intended use, which
includes taking into account the topology and morphology of the
site to be treated and the age/status of the patient (e.g., adult
or child). The tissue bandage structure 12 is desirably flexible
and relatively thin so that it can be rolled or folded upon itself
for deployment in a low profile condition, as FIGS. 2 to 5 show.
The tissue bandage structure 12 can be rectilinear, elongated,
square, round, oval, or a composite or complex combination thereof.
The shape, size, and configuration of tissue bandage structure 12
can be specially formed and adapted to the topology and morphology
of the site of application, by cutting, bending, or molding in
advance of use.
[0023] The tissue bandage structure 12 desirably includes an active
therapeutic surface 36 for contacting tissue. The active surface 36
desirably comprises a biocompatible material that reacts in the
presence of blood, body fluid, or moisture to become a strong
adhesive or glue. The material of the active surface 36 can, alone
or in combination with adhesive features, possess other beneficial
attributes, for example, anti-bacterial and/or anti-microbial
and/or anti-viral characteristics, and/or characteristics that
accelerate or otherwise enhance coagulation and the body's
defensive reaction to injury.
[0024] In one embodiment, the material of the active surface 36 of
the tissue bandage structure 12 comprises a hydrophilic polymer
form, such as a polyacrylate, an alginate, chitosan, a hydrophilic
polyamine, a chitosan derivative, polylysine, polyethylene imine,
xanthan, carrageenan, quaternary ammonium polymer, chondroitin
sulfate, a starch, a modified cellulosic polymer, a dextran,
hyaluronan or combinations thereof. The starch may be of amylase,
amylopectin and a combination of amylopectin and amylase.
[0025] In a preferred embodiment, the biocompatible material of the
active surface 36 comprises a non-mammalian material, which is most
prefrably poly [.beta.-(1-4)-2-amino-2-deoxy-D-glucopyranose, which
is more commonly referred to as chitosan.
[0026] The chitosan material is preferred because of the special
properties of the chitosan. The chitosan active surface 36 is
capable of adhering to a site of tissue injury along a body lumen
in the presence of blood, or body fluids, or moisture. The presence
of the chitosan active surface 36 stanches, seals, and/or
stabilizes the site of tissue injury, while establishing conditions
conducive to the healing of the site.
[0027] The chitosan material that is incorporated into the active
surface 36 can be produced in conventional ways. The structure or
form producing steps for the chitosan material are typically
carried out from a chitosan solution employing techniques such as
freezing (to cause phase separation), non-solvent die extrusion (to
produce a filament), electro-spinning (to produce a filament),
phase inversion and precipitation with a non-solvent (as is
typically used to produce dialysis and filter membranes) or
solution coating onto a preformed sponge-like or woven product. The
filament can be formed into a non-woven sponge-like mesh by
non-woven spinning processes. Alternately, the filament may be
produced into a felted weave by conventional spinning and weaving
processes. Improved compliance and flexibility can be achieved by
mechanical manipulation during or after manufacture, e.g., by
controlled micro-fracturing by rolling, bending, twisting,
rotating, vibrating, probing, compressing, extending, shaking and
kneading; or controlled macro-texturing (by the formation of deep
relief patterns) by thermal compression techniques. The tissue
bandage structure 12 can also comprise a sheet of woven or
non-woven mesh material enveloped between layers of the chitosan
material.
[0028] The active surface 36 that includes chitosan material
presents a robust, permeable, high specific surface area,
positively charged surface. The positively charged surface creates
a highly reactive surface for red blood cell and platelet
interaction. Red blood cell membranes are negatively charged, and
they are attracted to the chitosan material. The cellular membranes
fuse to chitosan material upon contact. A clot can be thrmed very
quickly, circumventing immediate need for clotting proteins that
are normally required for hemostasis. For this reason, the chitosan
material is effective for both normal as well as anti-coagulated
individuals, and as well as persons having a coagulation disorder
like hemophilia. The chitosan material also binds bacteria,
endotoxins, and microbes, and can kill bacteria, microbes, and/or
viral agents on contact.
[0029] B. The Delivery Device
[0030] As FIG. 1 shows, the delivery device 14 includes a
multi-lumen catheter tube 16 having a proximal end 18 and a distal
end 20. The distal end 20 carries an expandable structure 22, which
in the illustrated embodiment takes the form of an inflatable
balloon. Other non-inflatable, but nevertheless expandable or
enlargeable structures, can be used. The proximal end carries an
actuator 30 and a coupling 24 which are manipulated in synchrony
during operation of the expandable structure 22, as will be
described in greater detail later.
[0031] The catheter tube 16 can be formed of conventional polymeric
materials and include an interior lumen (not shown) that
accommodates passage of a guide wire 32. The lumen also passes
through the center of the expandable structure 22 as well. This
makes it possible to guide the intraluminal deployment of the
expandable structure 22 to an injury site within a body lumen or
hollow body organ targeted for treatment.
[0032] The catheter tube 16 includes another lumen that
communicates with the interior of the balloon 22. The proximal end
18 of the catheter tube 16 includes a coupling 24 for coupling an
inflation device 26, such as a syringe or the like (see FIG. 1), in
communication with the interior of the expandable structure 22.
Operation of the inflation device 26 conveys an appropriate
inflation medium (e.g., saline) into the expandable structure 22 to
cause it to expand.
[0033] The catheter tube also includes a movable sheath 28. The
sheath 28 comprises a material that is flexible and impermeable to
water. A push-pull wire 30 is coupled to the sheath 28, which
extends through another lumen within the catheter tube 16 and is
coupled to an actuator 30 on the proximal end 18 of the catheter
tube 16. Pushing on the actuator 30 advances the sheath 28 distally
over the expandable structure 22 (as shown in phantom lines in FIG.
1). Pulling on the actuator 30 withdraws the sheath 28 proximally
and free of the expandable structure 22 (as shown in solid lines in
FIG. 1).
[0034] In use, the tissue bandage structure 12 is sized and
configured to be carried about the expandable structure 22 in a
generally collapsed condition during introduction within the body
lumen or hollow body organ (see FIG. 10). The tissue bandage
structure is also sized and configured to be enlarged in response
to expansion of the expandable structure 22 (see FIG. 12) for
placement into contact with tissue in the body lumen or hollow body
organ.
[0035] FIGS. 2 to 5 show a representative embodiment of a flexible
chitosan bandage structure 12 that can be readily deployed using
the delivery device 14 in the manner just described. The bandage
structure 12 includes an inert, non-stick, water impermeable
coating 34 on a side opposite to the active chitosan surface 36. In
use, it is the active chitosan surface 36 that is placed into
contact with tissue. The inert, non-stick, water impermeable
coating 3.4 makes it possible to roll or fold the chitosan surface
34 about the expandable structure 22 for deployment without
sticking or adhering to the expandable structure 22 or itself.
[0036] Prior to intraluminal introduction of the delivery device 14
(see FIGS. 6 and 7), the sheath 28 is withdrawn, and the chitosan
bandage structure 12 is mounted about the expandable structure 22,
with the active chitosan surface 36 facing outward. In the
illustrated embodiment, this is accomplished by wrapping the
chitosan bandage structure 12 around the expandable structure 22,
with the non-stick coating 34 facing the expandable structure 22.
This corresponds to the generally collapsed condition described
above, which provides a low profile condition for intraluminal
introduction of the chitosan bandage structure 12.
[0037] In this arrangement, the flexible bandage structure 12 (see
FIGS. 2 to 5) has a rectangular shape with a tab 40 at one end. To
secure the bandage in a rolled position about the expandable
structure 22 (as shown in FIGS. 6 and 7), the tab can be inserted
into a slit 42 formed in the chitosan bandage structure 12. The
frictional force between the tab 40 and the walls of the slit 42
are sufficient to hold the bandage structure 12 in a rolled
position. However, when pressure is applied from within the rolled
bandage structure 12 (as is shown in FIG. 12 and will be described
later), the tab 40 slides out of the slit 42 and the bandage
structure 12 unfurls. Alternatively, the tab 40 and slit 42 can be
replaced by a biodegradable tape with a perforation that will be
more reliable in preventing premature deployment or unfurling of
the bandage structure 12.
[0038] Prior to intraluminal introduction, the sheath 28 is
advanced over the bandage structure 12 that has been wrapped about
the expandable structure 22 (see FIGS. 8 and 9). As FIG. 9 shows,
the distal end of the sheath 28 is closed by a frangible or
otherwise releasable securing device 44. The securing device 28
holds the distal end of the sheath 28 closed.
[0039] The securing device 44 can be variously constructed. It can,
e.g., comprise a removable slip-knot that releases when the sheath
is withdrawn, or a tearable perforated tab that tears when the
sheath is withdrawn, or a ring that slides off or breaks when
sheath is withdrawn.
[0040] In this position, the sheath 28 prevents contact between the
active chitosan surface 36 and the mucosa during introduction until
the instance of application. The sheath 28 protects the bandage
structure 12 from becoming moist until the sheath 28 is moved
proximally to reveal the bandage structure 12.
[0041] Prior to insertion into the body lumen (see FIG. 8), the
expandable structure 22 is desirably partially enlarged by
introduction of the inflating media (e.g., to about 0.25 atm) to
create bulbous forms on each side of the bandage structure 12 as
shown in FIG. 8. This partial expansion prevents the bandage
structure 12 from migrating from the center of the expandable
structure 22 during the introduction, but does not otherwise unfurl
the bandage structure 12, which remains in the generally collapsed
condition.
[0042] As will also be described later, when it is desired to
deploy the bandage structure 12, the sheath 28 is withdrawn (see
FIG. 11) and subsequent expansion of the expandable structure 22
(see FIG. 12) provides enough force to unfurl the bandage structure
12 into contact with an interior wall of the body lumen or hollow
body organ.
II. Use of the Delivery System
[0043] The delivery system 10 makes possible the deployment of a
chitosan bandage structure 12 within a body lumen or hollow body
organ under endoscopic visualization, e.g., to treat an injury of
the esophagus or other area of the gastrointestinal tract.
[0044] As FIGS. 6 to 9 show, the chitosan bandage structure 12 can
be wrapped and secured around the expandable structure 22 and
enclosed during introduction with the removable sheath 28. The
delivery device 12 can be deployed either over a guide wire 32
alongside an endoscope 50 (as FIG. 10 shows) or through the working
channel of an endoscope (as FIG. 15 shows). Once the chitosan
bandage structure 12 is positioned correctly over an injury site,
the removable sheath 28 is pulled back (see FIG. 11) to uncover the
chitosan bandage structure 12 for deployment. Subsequent expansion
of the expandable structure 22 (see FIG. 12) expands and unfurls
the chitosan bandage structure, holding it against the mucosa
circumferentially at the site of injury. After an appropriate
holding time (e.g., about three minutes), the expandable structure
22 is collapsed, and the delivery device 14 is withdrawn (see FIG.
13), leaving the chitosan bandage structure 12 at the injury site.
During the entire procedure, the endoscope 50 provides direct
visualization.
[0045] As the chitosan bandage structure 12 unfurls, it covers a
circumferential section of the body lumen or hollow body organ and
adheres to it. The properties of the active chitosan surface 36
serve to moderate bleeding, fluid seepage or weeping, or other
forms of fluid loss, while also promoting healing. Due to the
properties of the chitosan, the active surface 36 can also form an
anti-bacterial and/or anti-microbial and/or anti-viral protective
barrier at or surrounding the tissue treatment site within a body
lumen or hollow body organ. The active surface 36 (whether or not
it contains a chitosan material) can also provide a platform for
the delivery of one or more therapeutic agents into the blood
stream in a controlled release fashion. Examples of therapeutic
agents that can be incorporated into the active surface 36 of the
bandage structure 12 include, but are not limited to, drugs or
medications, stem cells, antibodies, anti-microbials, anti-virals,
collagens, genes, DNA, and other therapeutic agents; hemostatic
agents like fibrin; growth factors; Bone Morphogenic Protein (BMP);
and similar compounds.
[0046] The system 10 thereby makes possible an intraluminal
delivery method that (i) locates and identifies the site of injury
using an endoscope 50 and correlating video monitor; (ii) passes a
guide wire 32 into the site of injury; (iii) positions the distal
end of the delivery device 14 over the guide wire 32 (see FIG. 10)
at the site of injury while viewing the area with the endoscope 50,
which is positioned alongside the catheter tube 14; (iv) when
positioned over the site of injury, as confirmed by the endoscope
50, pulls the actuator 30 on the proximal end of the catheter tube
14 (see FIG. 11) to withdraw the sheath 28 (also thereby breaking
or otherwise releasing the security device 44) to unsheath and
expose the chitosan bandage structure 12; (v) expands the
expandable structure 22 (e.g., inflate the balloon) for a
prescribed period (e.g., about three minutes) (see FIG. 12) to
unfurl the bandage structure 12 and hold the active surface 36 of
the bandage structure 12 against mucosa; (vi) after the prescribed
holding period, collapses the expandable structure 22 (e.g. deflate
the balloon) and removes the delivery device 12 and guide wire 32
(see FIG. 13), while continuing to monitor with the endoscope 50,
if desired.
[0047] Various modifications of the above-described method can be
made. For example (see FIG. 14), between (ii) and (iii), an
over-tube 52 may be inserted in the body lumen to serve as a
delivery sheath as well as a further water impermeable barrier
between the device and the mucosa. As another example (see FIG.
15), the actuator 30 and coupling 24 can be separated from the
proximal end of the catheter tube 14, and the catheter tube 14
back-loaded (proximal end first) through the working channel 52 of
an endoscope 50. Once back-loaded, the proximal components are
re-connected to the catheter tube 14. This arrangement uses the
working channel 52 of the endoscope as a delivery sheath, instead
of or in combination with a guide wire and/or an over-tube.
[0048] The shape, shape, and configuration of the expandable body
and the bandage structure 12 can modified to accommodate varying
anatomies encountered within a body lumen or hollow body organ,
such as the gastrointestinal tract. This expands the possible use
of the delivery system 110 greatly. For example, in
esophagogastrectomies, an anastomosis between the stomach and the
esophagus is created where an asymmetric expandable structure 22
and a bandage structure 12 can be deployed by the system 10 to
cover the suture lines of the anastomosis. In addition, the size
and shape of the expandable structure 22 can be altered to
accommodate deployment of a bandage structure 12 in the duodenum or
stomach.
[0049] The intraluminal delivery method as described utilizes the
catheter-based delivery device 12, as described, to introduce a
flexible, relatively thin chitosan bandage structure 12, as
described, in an low profile condition and covered with a water
impermeable layer to a targeted treatment site within a body lumen
or hollow body organ, e.g. to treat esophageal injury. The delivery
method prevents the active chitosan surface 36 of the bandage
structure 12 from contacting the mucosa until the bandage structure
12 positioned in a desired position over the injury,
III. Conclusion
[0050] It has been demonstrated that a therapeutic bandage
structure can be introduced and deployed within a body lumen or
hollow body organ using an intraluminal delivery system 10 under
endoscopic guidance.
[0051] It should be apparent that above-described embodiments of
this invention are merely descriptive of its principles and are not
to be limited. The scope of this invention instead shall be
determined from the scope of the following claims, including their
equivalents.
* * * * *