U.S. patent application number 13/339910 was filed with the patent office on 2012-06-28 for endoscopic tissue stabilization device and related methods of use.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. Invention is credited to Yem CHIN, Paul SCOPTON.
Application Number | 20120165857 13/339910 |
Document ID | / |
Family ID | 34886022 |
Filed Date | 2012-06-28 |
United States Patent
Application |
20120165857 |
Kind Code |
A1 |
SCOPTON; Paul ; et
al. |
June 28, 2012 |
ENDOSCOPIC TISSUE STABILIZATION DEVICE AND RELATED METHODS OF
USE
Abstract
Embodiments of the invention include a sleeve for use in a body
lumen defined by body tissue. The sleeve includes a collapsible
wall defining a lumen and including an inflatable member configured
to increase a volume of the lumen when the inflatable member is in
an inflated state, a conduit configured to inflate the inflatable
member, and a port defined by the collapsible wall and in flow
communication with the lumen.
Inventors: |
SCOPTON; Paul; (Winchester,
MA) ; CHIN; Yem; (Burlington, MA) |
Assignee: |
Boston Scientific Scimed,
Inc.,
Maple Grove
MN
|
Family ID: |
34886022 |
Appl. No.: |
13/339910 |
Filed: |
December 29, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11058167 |
Feb 16, 2005 |
8088139 |
|
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13339910 |
|
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|
|
60544350 |
Feb 17, 2004 |
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Current U.S.
Class: |
606/192 |
Current CPC
Class: |
A61B 17/3417 20130101;
A61B 1/018 20130101; A61B 17/0218 20130101; A61B 1/2736 20130101;
A61B 1/12 20130101; A61B 17/320016 20130101; A61B 1/00082 20130101;
A61B 17/3439 20130101; A61B 1/31 20130101; A61B 10/04 20130101;
A61B 2017/00287 20130101; A61B 17/320783 20130101; A61B 17/00234
20130101; A61B 17/32056 20130101; A61B 18/082 20130101; A61B 1/0008
20130101; A61B 2017/00557 20130101; A61B 1/32 20130101; A61B 17/29
20130101; A61B 1/2733 20130101; A61B 2017/00269 20130101; A61B
17/12013 20130101 |
Class at
Publication: |
606/192 |
International
Class: |
A61M 29/02 20060101
A61M029/02 |
Claims
1-26. (canceled)
27. A sleeve for use in a body lumen, comprising: a wall defining a
lumen; a plurality of longitudinal non-inflating members; a
plurality of longitudinal inflatable members, wherein the plurality
of longitudinal inflatable members alternate with the plurality of
longitudinal non-inflating members about a circumference of the
wall; and a port in flow communication with the lumen.
28. The sleeve of claim 27, wherein the port is defined by a curved
portion of the wall.
29. The sleeve of claim 28, further comprising a plurality of
circular inflatable members disposed around the wall and separated
axially along a longitudinal axis of the sleeve.
30. The sleeve of claim 29, wherein at least one of the plurality
of circular inflatable members extends around the curved portion of
the wall.
31. The sleeve of claim 29, wherein the plurality of circular
inflatable members includes a first circular inflatable member, a
second circular inflatable member, a third circular inflatable
member, and a fourth circular inflatable member.
32. The sleeve of claim 31, wherein the first circular inflatable
member is adjacent a proximal edge of the port, the second circular
inflatable member is adjacent a distal edge of the port, the third
circular inflatable member is disposed on a proximal end of the
sleeve, and the fourth circular inflatable member is disposed on a
distal end of the sleeve.
33. The sleeve of claim 32, wherein the first circular inflatable
member, the second circular inflatable member, the third circular
inflatable member, and the fourth circular inflatable member are
configured to inflate to substantially the same diameter.
34. The sleeve of claim 29, wherein the plurality of longitudinal
inflatable members and the plurality of circular inflatable members
are in flow communication with each other.
35. The sleeve of claim 29, wherein the plurality of longitudinal
inflatable members and the plurality of circular inflatable members
are configured to increase a volume of the lumen when the plurality
of longitudinal inflatable members and the plurality of circular
inflatable members are in an inflated state.
36. The sleeve of claim 28, wherein the port includes a
substantially curved configuration.
37. The sleeve of claim 27, further comprising a conduit configured
to inflate the plurality of longitudinal inflatable members.
38. The sleeve of claim 37, further comprising a plurality of
circular inflatable members disposed around the wall and separated
axially along a longitudinal axis of the sleeve, wherein the
conduit is configured to deliver a fluid to the plurality of
longitudinal inflatable members and the plurality of circular
inflatable members to inflate the plurality of longitudinal
inflatable members and the plurality of circular inflatable
members.
39. The sleeve of claim 38, wherein at least one of the plurality
of circular inflatable members is disposed on an intermediate
portion of the sleeve.
40. The sleeve of claim 27, wherein the wall includes a proximal
end having a first substantially circular outer periphery and a
distal end having a second substantially circular outer
periphery.
41. A sleeve for use in a body lumen, comprising: a wall defining a
lumen; a plurality of longitudinal inflating members disposed about
a circumference of the wall; a plurality of circular inflatable
members disposed around the wall; and a port in flow communication
with the lumen, wherein the port is recessed relative to the
plurality of longitudinal inflating members and the plurality of
circular inflatable members when the plurality of longitudinal
inflating members and the plurality of circular inflatable members
are inflated.
42. The sleeve of claim 41, further comprising a plurality of
longitudinal non-inflating members, wherein the plurality of
longitudinal inflatable members alternate with the plurality of
longitudinal non-inflating members about the circumference of the
wall.
43. The sleeve of claim 42, wherein a first circular inflatable
member is adjacent a distal edge of the port, a second circular
inflatable member is adjacent a proximal edge of the port, a first
longitudinal inflatable member is adjacent a first lateral edge of
the port, and a second longitudinal inflatable member is adjacent a
second lateral edge of the port.
44. The sleeve of claim 43, wherein the first circular inflatable
member, the second circular inflatable member, the first
longitudinal inflatable member, and the second longitudinal
inflatable member are in flow communication with each other.
45. The sleeve of claim 44, wherein the first circular inflatable
member, the second circular inflatable member, the first
longitudinal inflatable member, and the second longitudinal
inflatable member surround the port and are configured to expand
outwardly from a surface defining the port.
46. The sleeve of claim 41, wherein the port is defined by a curved
portion of the wall.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefits of priority under 35
U.S.C. .sctn..sctn.119(e), 120 to U.S. Provisional Patent
Application No. 60/544,350, filed Feb. 17, 2004, the entirety of
which is incorporated herein by reference.
DESCRIPTION OF THE INVENTION
[0002] 1. Field of the Invention
[0003] Embodiments of the invention include a sleeve for use in a
body lumen defined by body tissue. The sleeve includes a
collapsible wall defining a lumen and including an inflatable
member configured to increase a volume of the lumen when the
inflatable member is in an inflated state, a conduit configured to
inflate the inflatable member, and a port defined by the
collapsible wall and in flow communication with the lumen.
[0004] 2. Background of the Invention
[0005] Endoscopic methods are commonly used for diagnosis and/or
treatment of the gastrointestinal tract. For example, there are
several methods of treating esophageal cancer known as endoscopic
mucosal resection. Endoscopic mucosal resection may include snaring
and then excising sessile adenomas (i.e., tumors attached to a
bodily surface) in the esophageal tract. If the adenoma is flat
against the esophageal tract, thus making it difficult to snare and
excise, one of several methods may be used to raise the flat
adenoma so that it may be snared and excised. One method includes
using forceps to raise the flat adenoma. Another method includes
using a vacuum to raise the flat adenoma. A further method includes
injecting saline into the submucosa so as to raise the flat
adenoma. If, during saline injection, it is determined that the
adenoma is attached to multiple esophageal layers, additional
methods may be required to remove the adenoma.
[0006] The aforementioned methods and other endoscopic methods
requiring access to tissue within the gastrointestinal tract, while
effective, have certain drawbacks. For example, due to the tissue
folds and constricted space in some portions of the
gastrointestinal tract, including the esophagus, it may be
difficult to identify, stabilize, access, and/or excise tissue even
with the use of an endoscope, especially if tissue such as an
adenoma is attached to multiple esophageal layers.
SUMMARY OF THE INVENTION
[0007] In accordance with the invention, an embodiment includes a
sleeve for use in a body lumen defined by body tissue. The sleeve
includes a collapsible wall defining a lumen and including an
inflatable member configured to increase a volume of the lumen when
the inflatable member is in an inflated state, a conduit configured
to inflate the inflatable member, and a port defined by the
collapsible wall and in flow communication with the lumen.
[0008] Various embodiments of the invention may include any or all
of the following features. When the inflatable member is in the
inflated state, the sleeve may be configured to substantially
stabilize the body tissue defining the body lumen. A non-inflating
reinforcing member may be configured to support the collapsible
wall. An embodiment may include alternating inflatable members and
non-inflatable reinforcing members. A plurality of non-inflating
reinforcing members may be arrange about an axis of the sleeve. The
plurality of non-inflating reinforcing members may be spaced apart
from each other. The collapsible wall may define an open proximal
end. The collapsible wall may define an open distal end. A
substantially planar portion of the collapsible wall may define the
port. A curved portion of the collapsible wall defines the port.
The inflatable member may include a plurality of longitudinal
channels interconnected by at least one circumferential channel.
The inflatable member may include at least one circumferential
channel. The inflatable member may include at least one
longitudinal channel. The inflatable member may include a plurality
of circumferential channels interconnected by at least one
longitudinal channel.
[0009] Another embodiment of the invention includes a method of
substantially stabilizing body tissue defining a body lumen. The
method includes providing a sleeve including a collapsible wall
defining a lumen and including an inflatable member configured to
increase a volume of the lumen when the inflatable member is in an
inflated state, the sleeve further including a conduit configured
to inflate the inflatable member and a port defined by the
collapsible wall and in flow communication with the lumen,
advancing the sleeve into the body lumen in a collapsed
configuration, and expanding the sleeve so as to exert pressure on
and thereby substantially stabilize body tissue defining the body
lumen.
[0010] Various embodiments of the invention may include any or all
of the following features. Expanding the sleeve may include
providing fluid to the inflatable member via the conduit. Orienting
the sleeve in the body lumen to position the port over a desired
portion of body tissue. Advancing the sleeve may include advancing
the sleeve through a working channel of an endoscope. The
inflatable member may include a plurality of longitudinal channels
interconnected by at least one circumferential channel. The
inflatable member may include at least one circumferential channel.
The inflatable member may include at least one longitudinal
channel. The inflatable member may include a plurality of
circumferential channels interconnected by at least one
longitudinal channel. The sleeve may includes a non-inflating
reinforcing member configured to support the collapsible wall. The
sleeve may include alternating inflatable members and
non-inflatable reinforcing members. The sleeve may include a
plurality of non-inflating reinforcing members arranged about an
axis of the sleeve. The plurality of non-inflating reinforcing
members may be spaced apart from each other.
[0011] Additional objects and advantages of the invention will be
set forth in part in the description which follows, and in part
will be obvious from the description, or may be learned by practice
of the invention. The objects and advantages of the invention will
be realized and attained by means of the elements and combinations
particularly pointed out in the appended claims.
[0012] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the invention, as
claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the invention and together with the description, serve to explain
the principles of the invention.
[0014] FIG. 1 is a perspective view of an endoscopic device
according to an embodiment of the invention.
[0015] FIG. 2 is a perspective view of an endoscopic device
according to another embodiment of the invention.
DESCRIPTION OF THE EMBODIMENTS
[0016] Reference will now be made in detail to the exemplary
embodiments of the invention, examples of which are illustrated in
the specification and accompanying drawings. Wherever possible, the
same reference numbers will be used throughout the specification
and drawings to refer to the same or like parts.
[0017] FIG. 1 depicts an exemplary embodiment of a sleeve. The
sleeve 1 may be used with an endoscope and/or one or more
endoscopic devices in a medical procedure such as endoscopic
mucosal resection, or any other suitable endoscopic or
non-endoscopic procedure. The sleeve 1 may include at least one
wall 10, at least one inflatable member 20, at least one port 30,
and at least one conduit 40.
[0018] The at least one wall 10 may be configured to collapse
and/or fold, for example, when external pressure is exerted on the
wall, in the absence of supporting structures for the wall, and/or
when inflatable members of device 1 (to be described herein) are in
an uninflated state. The sleeve 1 will be in a collapsed, or
contracted, state during its introduction to a tissue site. For
example, sleeve 1 will be collapsed when introduced through a
working channel of an endoscope. The wall 10 may be made from a
flexible polymer material or any other suitable, collapsible,
and/or biocompatible material known in the art.
[0019] The wall 10 may be reinforced using any method or structure
known in the art. For example, relatively rigid reinforcing members
11 made of any suitable material (e.g., metal, polymer) may be
disposed in the wall 10 so as to support the wall 10. In FIG. 1,
the reinforcing members 11 are coaxial with the longitudinal axis
12 of the sleeve 1 so as to reduce and/or prevent the bending of
the wall 10 and/or sleeve 1 in a desired direction, for example, in
the longitudinal direction. However, the reinforcing members 11 may
be disposed in, or make up part of, any other suitable orientation
on the sleeve 1 and/or wall 10 that permits wall 10 to collapse and
expand, and may have any desired dimensions, so as to reduce and/or
prevent the bending of the wall in any desired direction and/or
amount. Thus, in the configuration depicted in FIG. 1, the wall 10
would collapse between the reinforcing members 11.
[0020] The at least one inflatable member, or channel, 20 may be
configured to inflate and/or become relatively rigid with the
introduction of materials (e.g., gas(es), and/or liquid(s)) into
the inflatable member 20. The inflatable member 20 may be made of
substantially the same material as the wall 10, or may be made from
a different suitable material. In the uninflated state, the
inflatable member 20 may be configured to collapse.
[0021] FIG. 1 depicts inflatable members 20 integrated with the
wall 10. Some of the members 20A may be disposed around a central
lumen 21 and/or longitudinal axis 12 of sleeve 1, and substantially
form circles in their inflated state. In particular, sleeve 1
includes a substantially circular member 20A at each of a proximal
most end and a distal most end of sleeve 1. Sleeve 1 also includes
inflatable members 20A' along intermediate portions of sleeve 12
(i.e., non-proximal most and non-distal most portions of sleeve
12). Members 20A' have portions similar to substantially circular
members 20A, however, members 20A' may not extend fully around the
sleeve 12 so as to form a complete circle. Ends of member 20A' may
be integrated with other portions of members 20, for example,
members 20B as will be described below.
[0022] Other members 20B may be parallel to the longitudinal axis
12 and/or reinforcing members 11 so as to expand the sleeve 1 in
the longitudinal direction and/or provide support for the sleeve 1.
In the sleeve of FIG. 1, members 20B alternate with reinforcing
members 11 about the circumference of sleeve 1. At least some of
the inflatable members 20 may be in flow communication with each
other. For example, as shown in FIG. 1, the circular inflation
members 20A and 20A' may be in flow communication with the
longitudinal inflation members 20B and thereby in flow
communication with one another. However, the inflatable members 20
may also be divided into one or more discrete inflation systems
that are not in flow communication with each other.
[0023] The inflatable members 20, or at least the material defining
the inflatable members 20, may be discrete from the wall 10 and
instead be connected to the wall 10 using any method known in the
art, for example, adhesives. The inflatable members 10 may also be
disposed at any orientation with respect to the wall, and may have
any desired geometric configuration. When inflated, the inflatable
members 20 may cause the wall 10 to substantially flatten and/or
unfold (i.e., form a substantially wrinkle-free surface).
[0024] The at least one conduit 40 may be connected to wall 10
and/or inflatable members 20. The conduit 40 may be made out of the
same material as the wall 10 and/or inflatable members 20 as set
forth above, or it may be made from a different material known in
the art. The conduit 40 may be flexible and/or collapsible and
sufficiently long to extend from a tissue site within a
gastrointestinal tract, through tortuous anatomy, and external to
the patient.
[0025] The conduit 40 may be in fluid communication with the
inflatable members 20 so as to supply materials (e.g., gas(es),
and/or liquid(s)) from a materials source to the interior of the
inflatable members 20 and cause the inflatable members 20 to
inflate. The conduit 40 may be directly connected to at least one
of the inflatable members 20 and otherwise in fluid communication
with all of the inflatable members 20. In FIG. 1, the conduit 40 is
integrated with the wall 10 at the proximal end of sleeve 1. The
conduit 40 may be connected to the sleeve 1 using any connection
known in the art. At its proximal end, the conduit 40 may be
connected to an actuator and a materials supply source configured
to control the flow of materials to and/or from the sleeve 1 so as
to control the inflation and/or deflation of the sleeve 1.
[0026] Wall 10 defines at least one port 30. In FIG. 1, the port 30
is disposed on a center portion of one side of the wall 10 of
sleeve 1 and is substantially disposed between at least two
inflatable members 20A and at least two inflatable members 20B.
However, the port 30 may be disposed on other portions of sleeve 1
and may have a portion that traverses an inflatable member 20.
[0027] The port 30 may have any desired shape, dimensions and/or
configuration depending on several factors, among them the desired
tissue tract area to access and the size of the endoscopic devices
that may be advanced to or through the port. For example, as shown
in FIG. 1 the port 30 has a substantially flat and/or planar
configuration due to the substantially planar portion of wall 10
defining port 30.
[0028] The port 30 may also be configured so as to allow an
endoscopic tool to draw tissue from the gastrointestinal tract into
the central lumen 12 via the port 30, for example, using forceps or
suction. Once the tissue is disposed in the central lumen 12,
various endoscopic tools known in the art may be used to perform
therapy and/or diagnosis on the tissue.
[0029] The sleeve 1 and/or any of the aforementioned portions of
the sleeve 1 may have any desired shape, dimension and/or
configuration dependent on, for example, its deployment location.
For example, the sleeve 1 may be curved if the sleeve 1 is to be
deployed in a portion of the gastrointestinal tract where a bend
may be necessary. In another example, the sleeve 1 may have a
substantially D-shaped or oval cross-section.
[0030] The distal end 2 of the sleeve 1 may be sealed, for example,
to prevent materials from entering the central lumen 12 via the
distal end 2 of the sleeve 1. The proximal end 3 may also or
alternatively be sealed, for example, in conjunction with the
endoscope. If both the proximal end 3 and distal end 2 are sealed,
the proximal end 3 may be connected to a vacuum source and a vacuum
may be generated in the central lumen 12 of the sleeve 1 so as to
allow tissue from the gastrointestinal tract to be vacuumed into
the central lumen 12 of the sleeve 1 via the port 30.
[0031] At least one endoscopic tool may be used in conjunction with
the sleeve. For example, the endoscopic tool may include a forceps,
a biopsy forceps jaw, an aspirator, an irrigator, a scissors-like
devices, a knife, a cutter, an electrocautery device, a needle, a
snare, a basket, and any other endoscopic tool known in the art.
The endoscopic tool may be disposed in the central lumen 21 or may
be disposed external to the sleeve. The endoscopic tool may be
advanced through the same endoscope and/or endoscope channel as the
sleeve 1, or the endoscopic tool may be advanced into the
gastrointestinal tract independently of the sleeve 1. For example,
the endoscopic tool may be exterior and/or cross-parallel to the
endoscope. The central lumen 21 may include one or more tool
guiding channels configured to guide the endoscopic tool to a
desired portion of the sleeve 1, for example, port 30 and/or tissue
extending into the central lumen 21 via port 30. The tool guiding
channels may also be configured to guide the endoscopic tool out of
the sleeve 1, for example, through port 30, the opening on the
proximal end 3 of the sleeve 1, and/or the opening on the distal
end 2 of the sleeve 1.
[0032] The endoscopic tool used in conjunction with the sleeve 1
may be a cutter, such as a snare, configured to cut tissue, for
example, from the walls of the gastrointestinal tract. The tissue
may be cut by extending the cutter to or through the port 30. The
tissue may be cut by first drawing tissue into the central lumen 12
through the port and then cutting the tissue.
[0033] The sleeve 1 may include a pouch or other storage portion
configured to retrieve and store tissue samples acquired, for
example, using the aforementioned cutter. The pouch may be disposed
on any portion of the sleeve 1. For example, the pouch may be on
the wall 10 and/or inflatable member 20, and may be disposed on an
internal and/or external portion of the sleeve 1. The pouch may be
integrated with portions of the sleeve 1, or the pouch may be
manufactured separately from the sleeve 1 and then attached to the
sleeve 1, for example, using adhesives.
[0034] The sleeve 1 may include a portion for performing
electrocautery, for example, at least one cautery wire. The cautery
wire may be disposed on an external portion of and/or embedded in
one or more of the wall 10, inflatable member 20, and conduit 40 in
any desired shape, orientation, and/or configuration. The cautery
wire may be connected to an electrical power source external to the
patient through suitable leads or other wires. The cautery wire may
be configured to cauterize a portion of the tissue wall defining
the gastrointestinal tract that the cautery wire comes into contact
with.
[0035] One or more portions of the sleeve 1 may have a desired drug
coating. For example, external portions of the wall 10 may be
coated with a drug so that the wall 10, for example when inflated,
may deliver drugs to a portion of the tissue defining the
gastrointestinal tract. Alternatively or in combination with a drug
coating, sleeve 1 may include a coating of any other desired
therapeutic or diagnostic agent.
[0036] The sleeve 1 may have one or more conduits, in addition to
conduit 40, connected to sleeve 1 and extending proximally to the
exterior of the patient. The conduit may be disposed within the
central lumen 12, walls 10, and/or inflatable members 20. The
conduit may be disposed external to the sleeve 1. The conduit may
be configured to deliver materials (e.g., gas(es), and/or
liquid(s)) to one or more portions of the sleeve 1 and/or portions
of the gastrointestinal tract so as to flush the one or more
portions of the sleeve 1 and/or portions of the gastrointestinal
tract. The conduit may be configured to remove materials (e.g.,
gas(es), and/or liquid(s)) from one or more portions of the sleeve
1 and/or portions of the gastrointestinal tract.
[0037] FIG. 2 shows another embodiment of a sleeve 101 according to
the invention. The configuration of the sleeve 101 in FIG. 2 is
substantially similar to the configuration of the sleeve 1 in FIG.
1, except for the following differences. As shown in FIG. 2, the
port 130 may have a rounded and/or curved configuration due to the
substantially rounded or curved portion of wall 110 defining port
130. The sleeve 101 may also have inflation channels 120A' running
substantially adjacent to the proximal and distal edges of the port
130, for example, to add rigidity to the port 130. Various
inflation channels 120A' may combine to form an inflation channel
similar to inflations channels 120A, with a difference being that
the inflation channels 120A' are on an intermediate portion of the
sleeve 101. Ends of the inflation channels 120A' adjacent the port
130 may be integrated with inflation channels 120B. The inflation
channels 120, 120A, 120A', 120B may be in flow communication with
at least one conduit 140.
[0038] Embodiments of the invention include methods of using a
sleeve including any or all of the aspects set forth above. For
example, the method may include providing the sleeve 1 in a
collapsed configuration (i.e., the walls 10 and/or inflatable
members 20 are collapsed and not inflated), and then advancing the
sleeve 1 into the gastrointestinal tract using any method known in
the art. In some embodiments, the sleeve 1 may be advanced through
a working channel of an endoscope, however, in other embodiments
the sleeve 1 may be advanced into the gastrointestinal tract
independently of an endoscope. The reinforcing members 11 may
provide sufficient structural support to sleeve 1 to prevent the
sleeve 1 from knotting, tangling, and/or twisting to a degree that
does not permit the wall 10 and inflatable members 20 to properly
inflate once it is positioned in the desired portion of the
gastrointestinal tract.
[0039] When the sleeve 1 has been advanced to the desired portion
of the gastrointestinal tract, for example, the portion of the
gastrointestinal tract having an adenoma, the sleeve 1 may be
positioned so that the port 30 is adjacent the portion of the
gastrointestinal tract where therapy or diagnosis is desired.
Proper positioning may be achieved through any suitable imaging
method, including use of the optics of an endoscope.
[0040] Materials (e.g., gas(es), and/or liquid(s)) from a materials
source may then be advanced through conduit 40 into at least one
inflatable member 20 so as to inflate the at least one inflatable
member 20. As the inflatable member 20 inflates, the volume of the
central lumen 21 of the sleeve 1 expands due to the uncollapsing,
expansion, and/or straightening of the wall 10. As the sleeve 1
expands, the walls 10 and/or inflatable members 20 come into
contact with, and exert pressure on, the walls of gastrointestinal
tract and cause it to expand. During this expanding of the walls of
the gastrointestinal tract, the volume of the desired portion of
the gastrointestinal tract is increased, the folds of the tract
walls are smoothed out, and/or the desired portion of the
gastrointestinal tract is visible, stabilized, accessible, and/or
enters the central lumen 21 through the port 30. Once inflated, the
sleeve 1 forms a substantially rigid structure within the
gastrointestinal tract. During or after inflation of the sleeve 1,
the position of the port 30 may be adjusted as desired. For
example, if initial positioning does not permit access to the
desired tissue, sleeve 1 can be fully or partially uninflated and
repositioned. Once the port 30 is properly positioned, the port 30
may be used to permit access to the desired portion of the
gastrointestinal tract for therapy and/or diagnosis.
[0041] Various types of therapy may be conducted on the desired
tissue portion of the gastrointestinal tract via the walls 10, port
30, open distal end 2, and/or open proximal end 3, some exemplary
embodiments of which are set forth below.
[0042] If the distal end 2 and the proximal end 3 of the sleeve 1
are sealed, the port 30 may be placed substantially flush with the
desired tissue portion of the gastrointestinal tract, and then a
vacuum source connected to the central lumen 21 of the sleeve 1 may
be activated. Once activated, the desired tissue portion may be
aspirated into the central lumen 21 through the port 30, and then
therapy may be performed on the desired tissue portion.
[0043] If the distal end 2 and the proximal end 3 of the sleeve 1
are not sealed, the port 30 may be placed substantially flush with
the desired tissue portion of the gastrointestinal tract, and then
the desired tissue portion may be drawn into the central lumen 21
via the port 30 using a suitable medical device, for example
forceps or a separate suction device placed proximate port 30.
[0044] The desired tissue portion may be cut from the
gastrointestinal tract. The desired tissue portion may be cut using
a cutter known in the art, such as a snare or a biopsy forceps jaw.
The cutter may be advanced through the central lumen 21 and to or
out of the port 30. The cutter, or other endoscopic tool, may be
advanced to or out of the port 30 (or other desired portion of
sleeve 1) via a tool guiding channel. Once cut, the tissue portion
may be disposed in the central lumen 21 and then aspirated out of
the sleeve 1 via a device connected to the central lumen 21, for
example, a vacuum device. In the alternative, the tissue portion
may be placed in a pouch connected to and/or integrally formed
with, or separate from, the sleeve 1. As a further alternative, the
tissue may be removed via the closed jaws of a biopsy forceps jaw
assembly.
[0045] The desired tissue portion, and other portions of the
gastrointestinal tract, may be flushed and/or irrigated with
materials (e.g., gas(es), and/or liquid(s)) so as to, for example,
clear obstructions from the desired tissue portion. The materials
may be delivered via a conduit disposed in the central lumen 21 of
sleeve 1, via the central lumen 21 itself, a conduit integrated
with the sleeve 1, and/or a conduit disposed external to the sleeve
1.
[0046] The desired tissue portion, and other portions of the
gastrointestinal tract, may have materials removed so as to, for
example, clear obstructions from the desired tissue portion. The
materials may be removed via a conduit disposed in the central
lumen 21 of sleeve 1, via the central lumen 21 itself, a conduit
integrated with the sleeve 1, and/or a conduit disposed external to
the sleeve 1. The conduit may be connected to a suitable vacuum
source known in the art.
[0047] If drugs or other therapeutic or diagnostic agents are
coated on a portion of the sleeve 1, such as the walls 10, then the
sleeve 1 may be used to deliver drugs or agents to the desired
tissue portions of the gastrointestinal tract so as to conduct
chemical therapy on the desired tissue portions. The sleeve 1 may
be configured to apply the drug or agent evenly over the desired
tissue portion when the sleeve 1 is substantially in its fully
inflated configuration.
[0048] If cautery wires are embedded in the sleeve 1, the sleeve 1
may be used to cauterize portions of the gastrointestinal tract,
for example, by providing electricity to the cautery wires.
Electrocautery may be applied, for example, after severing tissue
from the tract.
[0049] Once the desired therapy has been completed, the sleeve 1
may be deflated by removing materials from the inflatable member 20
via the conduit 40 or another opening using any method known in the
art (e.g., opening a valve, puncturing a hole, and/or creating a
vacuum). During the removal of the materials, the inflatable member
20 and/or wall 10 may collapse, and then the sleeve 1 may be
removed from the gastrointestinal tract using any method known in
the art, such as retraction through the working channel of an
endoscope.
[0050] The devices and methods set forth above may be used in any
medical or non-medical procedure. For example, while the devices
and methods set forth above are disclosed as being used in treating
the gastrointestinal tract, they may also be used to treat any body
lumen or organ.
[0051] Any of the various aspects set forth in any of the
embodiments may be used in conjunction with any other aspect set
forth in any of the embodiments. For example, more than one sleeve
1 may be advanced into the gastrointestinal tract. Moreover,
aspects may be removed from embodiments if desired.
[0052] The sleeve 1 may have any desired dimensions, orientation,
and/or configuration, for example, dimensions, orientation, and/or
configuration that correspond to a particular portion of the
gastrointestinal tract.
[0053] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims.
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