U.S. patent application number 16/818600 was filed with the patent office on 2020-09-10 for balloon endoscope and methods of manufacture and use thereof.
The applicant listed for this patent is SMART Medical Systems Ltd.. Invention is credited to Gilad Luria, Gad Terliuc.
Application Number | 20200281450 16/818600 |
Document ID | / |
Family ID | 1000004853394 |
Filed Date | 2020-09-10 |
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United States Patent
Application |
20200281450 |
Kind Code |
A1 |
Terliuc; Gad ; et
al. |
September 10, 2020 |
BALLOON ENDOSCOPE AND METHODS OF MANUFACTURE AND USE THEREOF
Abstract
A balloon endoscope including an endoscope body having a
selectably pressurizable interior volume, which generally fills the
interior of the endoscope body and a selectably inflatable balloon
located on an outer surface of the endoscope body and defining a
balloon volume which communicates with the interior volume for
selectable inflation of the balloon by selectable pressurization of
the interior volume.
Inventors: |
Terliuc; Gad; (Ra'anana,
IL) ; Luria; Gilad; (Givataim, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SMART Medical Systems Ltd. |
Ra'anana |
|
IL |
|
|
Family ID: |
1000004853394 |
Appl. No.: |
16/818600 |
Filed: |
March 13, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16048031 |
Jul 27, 2018 |
10610086 |
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16818600 |
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13583634 |
Sep 9, 2012 |
10052014 |
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PCT/IL2011/000222 |
Mar 9, 2011 |
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16048031 |
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61282624 |
Mar 9, 2010 |
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61282623 |
Mar 9, 2010 |
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61344690 |
Sep 14, 2010 |
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61457236 |
Feb 9, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/015 20130101;
A61B 1/32 20130101; A61B 1/00082 20130101; A61B 1/0011 20130101;
A61B 1/00057 20130101; A61B 1/31 20130101; Y10T 29/49817 20150115;
A61B 2090/0809 20160201; Y10T 29/49826 20150115 |
International
Class: |
A61B 1/015 20060101
A61B001/015; A61B 1/00 20060101 A61B001/00; A61B 1/31 20060101
A61B001/31; A61B 1/32 20060101 A61B001/32 |
Claims
1-47. (canceled)
48. A balloon endoscope comprising: an endoscope body having a
selectably pressurizable interior volume, which generally fills the
interior of said endoscope body; a selectably inflatable balloon
located on an outer surface of said endoscope body; and a balloon
inflation/deflation control system communicating with said
selectably pressurizable interior volume and with said selectably
inflatable balloon and being operative to provide automatic leak
testing of at least one of said selectably pressurizable interior
volume and said selectably inflatable balloon.
49. A balloon endoscope according to claim 48 and wherein said
balloon inflation/deflation control system has at least two modes
of operation including: a positive pressure leak testing mode; and
a negative pressure leak testing mode.
50. A balloon endoscope according to claim 48 and wherein said
balloon inflation/deflation control system includes at least one of
the following operational modules: an initialization module,
operable prior to an endoscopy procedure; a real time leak
monitoring balloon inflation module, operable during an endoscopy
procedure; and a real time leak monitoring balloon deflation
module, operable during an endoscopy procedure.
51. A balloon endoscope according to claim 48 and wherein said
balloon inflation/deflation control system includes at least two of
the following operational modules: an initialization module,
operable prior to an endoscopy procedure; a real time leak
monitoring balloon inflation module, operable during an endoscopy
procedure; and a real time leak monitoring balloon deflation
module, operable during an endoscopy procedure.
52. A balloon endoscope according to claim 48 and wherein said
balloon inflation/deflation control system includes the following
operational modules: an initialization module, operable prior to an
endoscopy procedure; a real time leak monitoring balloon inflation
module, operable during an endoscopy procedure; and a real time
leak monitoring balloon deflation module, operable during an
endoscopy procedure.
53. A balloon endoscope according to claim 50 and wherein said
initialization module includes the following functionality: balloon
endoscope pressurization producing balloon inflation; pressure leak
test when said balloon endoscope is in a pressurized state and the
balloon is surrounded by a balloon confining, gas permeable collar
member; balloon endoscope depressurization producing balloon
deflation; vacuum leak test when said balloon endoscope is in a
pressurized state; and provision of system go/no go indication.
54. A balloon endoscope according to claim 50 and wherein said real
time leak monitoring balloon inflation module includes the
following functionality: balloon endoscope pressurization producing
balloon inflation; provision of complete balloon inflation
indication; pressure leak test when said balloon endoscope is in a
pressurized state within a body cavity; and provision of leak
indication.
55. A balloon endoscope according to claim 50 and wherein said real
time leak monitoring balloon deflation module includes the
following functionality: balloon endoscope depressurization
producing balloon deflation; provision of complete balloon
deflation indication to the operator; pressure leak test when said
balloon endoscope is in a depressurized state within a body cavity;
and provision of leak indication.
56. A balloon endoscope according to claim 48 and also including an
endoscope tool balloon and wherein said balloon inflation/deflation
control system comprises: an endoscope balloon inflation/deflation
control system sub-system communicating with said selectably
pressurizable interior volume and with said selectably inflatable
balloon and being operative to provide automatic leak testing of at
least one of said selectably pressurizable interior volume and said
selectably inflatable balloon; and an endoscope tool balloon
inflation/deflation control system sub-system communicating with
said endoscope tool balloon and being operative to provide
automatic leak testing of said endoscope tool balloon.
57. A balloon endoscope according to claim 48 and wherein said
selectably inflatable balloon is retrofitted onto said endoscope
body.
58-66. (canceled)
67. A method for balloon endoscopy comprising: providing an
endoscope including an endoscope body having a selectably
pressurizable interior volume and a selectably inflatable balloon
located on an outer surface of said endoscope body; and providing
automatic leak testing of at least one of said selectably
pressurizable interior volume and said selectably inflatable
balloon.
68-77. (canceled)
Description
REFERENCE TO RELATED APPLICATIONS
[0001] Reference is made to U.S. Provisional Patent Application
Ser. No. 61/282,623, filed Mar. 9, 2010 and entitled "Endoscope
with external fluid communication," U.S. Provisional Patent
Application Ser. No. 61/282,624, filed Mar. 9, 2010 and entitled
"Balloon Endoscope with internal fluid communication," U.S.
Provisional Patent Application Ser. No. 61/344,690, filed Sep. 14,
2010 and entitled "Endoscope with External Gas Communication," and
U.S. Provisional Patent Application Ser. No. 61/457,236, filed Feb.
9, 2011 and entitled "Manufacturing Methods of Balloon Endoscope
with External Fluid Communication," the disclosures of which are
hereby incorporated by reference and priorities of which are hereby
claimed pursuant to 35 U.S.C. 33 CFR 1.38(a) (4) and (5)(i).
[0002] Reference is also made to applicant's copending PCT
Application No. PCT/IL2005/000152, filed Feb. 7, 2005; PCT
Application No. PCT/IL2005/000849, filed Aug. 8, 2005; PCT
Application No. PCT/IL2007/000600, filed May 17, 2007; PCT
Application No. PCT/IL2007/000832, filed Jul. 4, 2007; PCT
Application No. PCT/IL2008/000687, filed May 20, 2008; PCT
Application No. PCT/IL2009/000322, filed Mar. 23, 2009; PCT
Application No. PCT/IL2009/000940, filed Oct. 1, 2009; and PCT
Application No. PCT/IL2010/000425, filed May 30, 2010, the
disclosures of which are hereby incorporated by reference.
FIELD OF THE INVENTION
[0003] The present invention relates to endoscopy generally and
more particularly to balloon endoscopes.
BACKGROUND OF THE INVENTION
[0004] The following patent publications and commercially available
products are believed to represent the current state of the
art:
[0005] U.S. Pat. Nos. 3,837,347; 4,040,413; 4,148,307; 4,176,662;
4,195,637; 4,261,339; 4,453,545; 4,616,652; 4,676,228; 4,862,874;
4,917,088; 5,135,487; 5,259,366; 5,593,419; 6,007,482; 6,461,294;
6,585,639; 6,663,589; and 6,702,735;
[0006] U.S. patent application publication Nos. 2003/0244361;
2004/0102681; 2005/0124856; 2005/0125005; 2005/0133453;
2005/0137457; 2005/0165233; 2005/0165273; 2005/0171400;
2006/0111610; and 2006/0161044;
[0007] Japanese Patent Application publication No.
JP2003-250896;
[0008] Published PCT Patent Applications WO 2005/074377; WO
2005/017854; WO 2007/135665; WO 2008/004228; WO 2008/142685; WO
2009/122395; WO 2010/046891; WO 2010/137025; and
[0009] Double Balloon Endoscope product, including EC-450BI5
colonoscope, TS-13101 overtube and BS-2 front balloon, which
interface with balloon pump controller BP-20 and EPX-4400HD video
system, all commercially available from Fujinon Inc., of 10 High
Point Drive, Wayne, N.J., USA; and,
[0010] Single Balloon Endoscope product, including SIF-Q180
enteroscope, ST-SB1 overtube, which interface with balloon pump
control OBCU and EVIS EXERA II system video system, ail
commercially available from Olympus Inc., of 3500 Corporate Parkway
Center Valley, Pa. 18034-0610, USA.
SUMMARY OF THE INVENTION
[0011] The present invention seeks to provide improved balloon
endoscopes and method of manufacture thereof.
[0012] There is thus provided in accordance with a preferred
embodiment of the present invention a balloon endoscope including
an endoscope body having a selectably pressurizable interior
volume, which generally fills the interior of the endoscope body
and a selectably inflatable balloon located on an outer surface of
the endoscope body and defining a balloon volume which communicates
with the interior volume for selectable inflation of the balloon by
selectable pressurization of the interior volume.
[0013] Preferably, at least one conduit extends through at least
part of the selectably pressurizable interior volume.
[0014] In accordance with a preferred embodiment of the present
invention at least one fluid conduit extends through at least part
of the selectably pressurizable interior volume and is sealed
therefrom.
[0015] Preferably, the at least one conduit includes an instrument
channel. Additionally or alternatively, the endoscope body includes
a leak test port communicating with the selectably pressurizable
interior volume. Alternatively or additionally, the balloon
endoscope also includes a fluid flow discriminator at a forward
portion of the selectably pressurizable interior volume which
prevents passage of liquid but permits passage of gas
therethrough.
[0016] Preferably, the balloon endoscope also includes a balloon
inflation/deflation control system communicating with the
selectably pressurizable interior volume and with the selectably
inflatable balloon and being operative to provide automatic leak
testing of at least one of the selectably pressurizable interior
volume and the selectably inflatable balloon. Additionally, the
balloon inflation/deflation control system has at least two modes
of operation including a positive pressure leak testing mode and a
negative pressure leak testing mode.
[0017] In accordance with a preferred embodiment of the present
invention the selectably inflatable balloon is retrofitted onto the
endoscope body. Additionally or alternatively, the selectably
inflatable balloon includes generally cylindrical rearward and
forward ends having a fixed inner cross-sectional radius R1, a
central cylindrical portion having a fixed inner cross-sectional
radius R2, when inflated to a nominal pressure, slightly in excess
of atmospheric pressure, and circularly symmetric tapered portions
extending between the central cylindrical portion and each of the
rearward and forward ends, whose inner radius changes from R2 to R1
where cos(Alpha) is approximately equal to r/R2, r is the inner
radius of the balloon at a given location between the central
cylindrical portion and one of the rearward and forward ends; and
Alpha is the angle between a tangent to the balloon at the given
location and a longitudinal axis of symmetry of the balloon.
[0018] Preferably, the selectably inflatable balloon is integrally
formed as part of an outer sheath of the endoscope. In accordance
with a preferred embodiment of the present invention the balloon
endoscope also includes a bending section including a bending
rubber sheath and the selectably inflatable balloon is located
rearwardly of the bending rubber sheath.
[0019] Preferably, the selectably inflatable balloon is removably
mounted onto the outer surface of the endoscope. In accordance with
a preferred embodiment of the present invention the balloon
endoscope also includes a bending section including a bending
rubber sheath and wherein the selectably inflatable balloon
overlies the bending rubber sheath. Additionally, the selectably
inflatable balloon is generally coextensive with the bending rubber
sheath.
[0020] There is also provided in accordance with another preferred
embodiment of the present invention a balloon endoscope including
an endoscope body having a leak test port and a selectably
inflatable balloon associated with the endoscope body and defining
a balloon volume which communicates with the leak test port.
[0021] Preferably, the endoscope body has a selectably
pressurizable interior volume, which generally fills the interior
of the endoscope body. Additionally or alternatively, the
selectably inflatable balloon is located on an outer surface of the
endoscope body. Alternatively or additionally, the balloon volume
communicates with the interior volume for selectable inflation of
the balloon by selectable pressurization of the interior volume via
the leak test port.
[0022] In accordance with a preferred embodiment of the present
invention at least one conduit extends through at least part of the
selectably pressurizable interior volume. Preferably, at least one
fluid conduit extends through at least part of the selectably
pressurizable interior volume and is sealed therefrom.
Additionally, the at least one conduit includes an instrument
channel.
[0023] Preferably, the balloon endoscope also includes a fluid flow
discriminator communicating with the balloon volume, which prevents
passage of liquid but permits passage of gas therethrough.
Additionally or alternatively, the balloon endoscope also includes
a balloon inflation/deflation control system communicating with the
balloon volume and being operative to provide automatic leak
testing of the selectably inflatable balloon. Additionally, the
balloon inflation/deflation control system has at least two modes
of operation including a positive pressure leak testing mode and a
negative pressure leak testing mode.
[0024] In accordance with a preferred embodiment of the present
invention the selectably inflatable balloon is retrofitted onto the
endoscope body. Additionally or alternatively, the selectably
inflatable balloon includes generally cylindrical rearward and
forward ends having a fixed inner cross-sectional radius R1, a
central cylindrical portion having a fixed inner cross-sectional
radius R2, when inflated to a nominal pressure, slightly in excess
of atmospheric pressure, and circularly symmetric tapered portions
extending between the central cylindrical portion and each of the
rearward and forward ends, whose inner radius changes from R2 to R1
where cos(Alpha) is approximately equal to r/R2, r is the inner
radius of the balloon at a given location between the central
cylindrical portion and one of the rearward and forward ends and
Alpha is the angle between a tangent to the balloon at the given
location and a longitudinal axis of symmetry of the balloon.
[0025] Preferably, the selectably inflatable balloon is integrally
formed as part of an outer sheath of the endoscope. In accordance
with a preferred embodiment of the present invention the balloon
endoscope also includes a bending section including a bending
rubber sheath and the selectably inflatable balloon is located
rearwardly of the bending rubber sheath.
[0026] In accordance with a preferred embodiment of the present
invention the selectably inflatable balloon is removably mounted
onto an outer surface of the endoscope. Additionally or
alternatively, the balloon endoscope also includes a bending
section including a bending rubber sheath and the selectably
inflatable balloon overlies the bending rubber sheath. In
accordance with a preferred embodiment of the present invention the
selectably inflatable balloon is generally coextensive with the
bending rubber sheath.
[0027] There is further provided in accordance with yet another
preferred embodiment of the present invention an endoscope
including an endoscope body having a forward portion and a rearward
portion and a fluid passageway extending from the rearward portion
to the forward portion and including a fluid flow discriminator at
the forward portion which prevents passage of liquid but permits
passage of gas.
[0028] Preferably, the fluid passageway includes an interior volume
of the endoscope body, which generally fills the interior of the
endoscope body. In accordance with a preferred embodiment of the
present invention the fluid passageway includes a conduit extending
through an interior volume of the endoscope body, which interior
volume generally fills the interior of the endoscope body.
[0029] In accordance with a preferred embodiment of the present
invention the fluid passageway includes a conduit. Preferably, the
fluid passageway communicates with a leak test port of the
endoscope.
[0030] In accordance with a preferred embodiment of the present
invention the endoscope also includes a selectably inflatable
balloon located on an outer surface of the endoscope body and
defining a balloon volume which communicates with the fluid
passageway for selectable inflation of the balloon. Additionally
the selectably inflatable balloon is removably mounted onto the
outer surface of the endoscope body.
[0031] In accordance with a preferred embodiment of the present
invention the fluid flow discriminator includes a gas permeable,
liquid impermeable filter. Additionally or alternatively, the
endoscope also includes a balloon inflation/deflation control
system communicating with the fluid passageway.
[0032] Preferably, the selectably inflatable balloon is retrofitted
onto the endoscope body. In accordance with a preferred embodiment
of the present invention the selectably inflatable balloon includes
generally cylindrical rearward and forward ends having a fixed
inner cross-sectional radius R1, a central cylindrical portion
having a fixed inner cross-sectional radius R2, when inflated to a
nominal pressure, slightly in excess of atmospheric pressure, and
circularly symmetric tapered portions extending between the central
cylindrical portion and each of the rearward and forward ends,
whose inner radius changes from R2 to R1 where cos(Alpha) is
approximately equal to r/R2, r is the inner radius of the balloon
at a given location between the central cylindrical portion and one
of the rearward and forward ends and Alpha is the angle between a
tangent to the balloon at the given location and a longitudinal
axis of symmetry of the balloon.
[0033] In accordance with a preferred embodiment of the present
invention the selectably inflatable balloon is integrally formed as
part of an outer sheath of the endoscope. Preferably, the balloon
endoscope also includes a bending section including a bending
rubber sheath and the selectably inflatable balloon is located
rearwardly of the bending rubber sheath.
[0034] Preferably, the balloon endoscope also includes a bending
section including a bending rubber sheath and wherein the
selectably inflatable balloon overlies the bending rubber sheath.
Additionally, the selectably inflatable balloon is generally
coextensive with the bending rubber sheath.
[0035] There is yet further provided in accordance with still
another preferred embodiment of the present invention a balloon
endoscope including an endoscope body having a selectably
pressurizable interior volume, which generally fills the interior
of the endoscope body, a selectably inflatable balloon located on
an outer surface of the endoscope body and a balloon
inflation/deflation control system communicating with the
selectably pressurizable interior volume and with the selectably
inflatable balloon and being operative to provide automatic leak
testing of at least one of the selectably pressurizable interior
volume and the selectably inflatable balloon.
[0036] Preferably, the balloon inflation/deflation control system
has at least two modes of operation including a positive pressure
leak testing mode and a negative pressure leak testing mode.
[0037] In accordance with a preferred embodiment of the present
invention the balloon inflation/deflation control system includes
at least one of the following operational modules: an
initialization module, operable prior to an endoscopy procedure, a
real time leak monitoring balloon inflation module, operable during
an endoscopy procedure and a real time leak monitoring balloon
deflation module, operable during an endoscopy procedure.
[0038] More preferably, the balloon inflation/deflation control
system includes at least two of the following operational modules:
an initialization module, operable prior to an endoscopy procedure,
a real time leak monitoring balloon inflation module, operable
during an endoscopy procedure and a real time leak monitoring
balloon deflation module, operable during an endoscopy procedure.
Most preferably, the balloon inflation/deflation control system
includes the following operational modules: an initialization
module, operable prior to an endoscopy procedure, a real time leak
monitoring balloon inflation module, operable during an endoscopy
procedure and a real time leak monitoring balloon deflation module,
operable during an endoscopy procedure.
[0039] In accordance with a preferred embodiment of the present
invention the initialization module includes the following
functionality: balloon endoscope pressurization producing balloon
inflation, pressure leak test when the balloon endoscope is in a
pressurized state and the balloon is surrounded by a balloon
confining, gas permeable collar member, balloon endoscope
depressurization producing balloon deflation, vacuum leak test when
the balloon endoscope is in a pressurized state and provision of
system go/no go indication.
[0040] Preferably, the real time leak monitoring balloon inflation
module includes the following functionality: balloon endoscope
pressurization producing balloon inflation, provision of complete
balloon inflation indication, pressure leak test when the balloon
endoscope is in a pressurized state within a body cavity and
provision of leak indication.
[0041] In accordance with a preferred embodiment of the present
invention the real time leak monitoring balloon deflation module
includes the following functionality: balloon endoscope
depressurization producing balloon deflation, provision of complete
balloon deflation indication to the operator, pressure leak test
when the balloon endoscope is in a depressurized state within a
body cavity and provision of leak indication.
[0042] Preferably, the balloon endoscope also includes an endoscope
tool balloon and the balloon inflation/deflation control system
includes: an endoscope balloon inflation/deflation control system
sub-system communicating with the selectably pressurizable interior
volume and with the selectably inflatable balloon and being
operative to provide automatic leak testing of at least one of the
selectably pressurizable interior volume and the selectably
inflatable balloon and an endoscope tool balloon
inflation/deflation control system sub-system communicating with
the endoscope tool balloon and being operative to provide automatic
leak testing of the endoscope tool balloon.
[0043] In accordance with a preferred embodiment of the present
invention the selectably inflatable balloon is retrofitted onto the
endoscope body.
[0044] There is even further provided in accordance with another
preferred embodiment of the present invention a method for balloon
endoscopy including providing an endoscope including an endoscope
body having a selectably pressurizable interior volume, which
generally fills the interior of the endoscope body, and a
selectably inflatable balloon and selectably inflating the
selectably inflatable balloon by selectable pressurization of the
interior volume.
[0045] Preferably, the selectably inflating includes selectably
inflating the selectably inflatable balloon via a leak test port
communicating with the selectably pressurizable interior volume.
Additionally or alternatively, the selectably inflating includes
enabling passage of gas but not liquid between the selectably
pressurizable interior volume and the selectably inflatable
balloon.
[0046] In accordance with a preferred embodiment of the present
invention the selectably inflating includes providing automatic
leak testing of at least one of the selectably pressurizable
interior volume and the selectably inflatable balloon.
[0047] There is also provided in accordance with still another
preferred embodiment of the present invention a method for balloon
endoscopy including providing an endoscope including an endoscope
body having a leak test port and a selectably inflatable balloon
and selectably inflating the selectably inflatable balloon via the
leak test port.
[0048] Preferably, the selectably inflating includes enabling
passage of gas but not liquid between the selectably pressurizable
interior volume and the the selectably inflatable balloon.
Additionally or alternatively, the selectably inflating includes
providing automatic leak testing of at least one of the selectably
pressurizable interior volume and the selectably inflatable
balloon.
[0049] There is further provided in accordance with yet another
preferred embodiment of the present invention a method for balloon
endoscopy including providing an endoscope having a forward portion
and a rearward portion and a fluid passageway extending from the
rearward portion to the forward portion and providing passage of
gas but not liquid between the fluid passageway and a location
outside the endoscope at the forward portion thereof.
[0050] In accordance with a preferred embodiment of the present
invention the method for balloon endoscopy also includes selectably
pressurizing the fluid passageway and providing gas communication
between the fluid passageway and a balloon volume defined at the
interior of a selectably inflatable balloon sealingly mounted over
an outer surface of the forward portion of the endoscope.
[0051] There is still further provided in accordance with another
preferred embodiment of the present invention a method for balloon
endoscopy including providing an endoscope including an endoscope
body having a selectably pressurizable interior volume and a
selectably inflatable balloon located on an outer surface of the
endoscope body and providing automatic leak testing of at least one
of the selectably pressurizable interior volume and the selectably
inflatable balloon.
[0052] There is even further provided in accordance with still
another preferred embodiment of the present invention a method of
manufacture of a balloon endoscope including providing an at least
partially complete endoscope having a selectably pressurizable
interior volume, providing at least one aperture in an outer sheath
of the endoscope, the at least one aperture communicating with the
selectably pressurizable interior volume and providing a selectably
inflatable balloon over the outer sheath and in sealing engagement
therewith, the balloon being arranged to have a balloon volume
overlying the at least one aperture.
[0053] Preferably, the providing an at least partially complete
endoscope includes providing an endoscope lacking at least part of
the outer sheath and the providing at least one aperture includes
forming an aperture in an outer sheath and thereafter mounting the
outer sheath on the endoscope.
[0054] In accordance with a preferred embodiment of the present
invention the method of manufacture of a balloon endoscope also
includes associating a fluid flow discriminator with the at least
one aperture. Additionally or alternatively, the providing an at
least partially complete endoscope includes retrofitting the
endoscope to remove at least part of the outer sheath thereof.
[0055] There is still further provided in accordance with yet
another preferred embodiment of the present invention a method of
manufacture of an endoscope including providing an at least
partially complete endoscope and providing at least one aperture in
an outer sheath of the endoscope and associating a fluid flow
discriminator with the at least one aperture.
[0056] In accordance with a preferred embodiment of the present
invention the method of manufacture of an endoscope also includes
providing a selectably inflatable balloon over the outer sheath and
in sealing engagement therewith, the balloon being arranged to have
a balloon volume overlying the at least one aperture. Additionally
or alternatively, the providing an at least partially complete
endoscope includes providing an endoscope lacking at least part of
the outer sheath and the providing at least one aperture includes
forming an aperture in an outer sheath and thereafter mounting the
outer sheath on the endoscope.
[0057] There is even further provided in accordance with still
another preferred embodiment of the present invention a method of
reprocessing a balloon endoscope including inflating a balloon of
the balloon endoscope and reprocessing the balloon endoscope while
the balloon is inflated. Preferably, the method of reprocessing the
balloon endoscope also includes, prior to inflating the balloon of
the balloon endoscope, placing a liquid spray permeable inflation
limiting collar over the balloon.
[0058] There is yet further provided in accordance with another
preferred embodiment of the present invention an
inflatable/deflatable balloon suitable for use as part of a balloon
endoscope or balloon catheter and including generally cylindrical
rearward and forward ends having a fixed inner cross-sectional
radius R1, a central cylindrical portion having a fixed inner
cross-sectional radius R2, when inflated to a nominal pressure,
slightly in excess of atmospheric pressure, and circularly
symmetric tapered portions extending between the central
cylindrical portion and each of the rearward and forward ends,
whose inner radius changes from R2 to R1 where: cos(Alpha) is
approximately equal to r/R2, r is the inner radius of the balloon
at a given location between the central cylindrical portion and one
of the rearward and forward ends and Alpha is the angle between a
tangent to the balloon at the given location and a longitudinal
axis of symmetry of the balloon.
BRIEF DESCRIPTION OF THE DRAWINGS
[0059] The present invention will be understood and appreciated
from the following detailed description, taken in conjunction with
the drawings in which:
[0060] FIGS. 1A & 1B illustrate a first embodiment of a balloon
endoscope constructed and operative in accordance with the present
invention;
[0061] FIGS. 2A & 2B illustrate a second embodiment of a
balloon endoscope constructed and operative in accordance with the
present invention;
[0062] FIGS. 3A & 3B illustrate a third embodiment of a balloon
endoscope constructed and operative in accordance with the present
invention;
[0063] FIG. 4 is a simplified illustration of an
inflation/deflation control system preferably forming part of the
balloon endoscopes of FIGS. 1A-3B;
[0064] FIGS. 5A-5J are together a simplified pictorial flowchart
which illustrates operation of a balloon endoscope in accordance
with a preferred embodiment of the present invention; and
[0065] FIGS. 6A-6I are simplified pictorial illustrations of a
method of manufacture of a balloon endoscope in accordance with a
preferred embodiment of the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0066] The terms "endoscope" and "endoscopy" are used throughout in
a manner somewhat broader than their customary meaning and refer to
apparatus and methods which operate within body cavities,
passageways and the like, such as, for example, the small intestine
and the large intestine. Although these terms normally refer to
visual inspection, as used herein they are not limited to
applications which employ visual inspection and refer as well to
apparatus, systems and methods which need not necessarily involve
visual inspection.
[0067] The term "forward" refers to the remote end of an endoscope,
accessory or tool furthest from the operator or to a direction
facing such remote end.
[0068] The term "rearward" refers to the end portion of an
endoscope, accessory or tool closest to the operator, typically
outside an organ or body portion of interest or to a direction
facing such end portion.
[0069] Reference is now made to FIGS. 1A & 1B, which illustrate
a first embodiment of a balloon endoscope constructed and operative
in accordance with the present invention. As seen in FIGS. 1A &
1B, an endoscope 100 is connected to an endoscope system (not
shown). Other than as specifically described hereinbelow, the
endoscope 100 may be a conventional endoscope such as an EC-3470LK
video colonoscope or a VSB-3430K video enteroscope which are
commercially available from Pentax Europe GmbH, 104 Julius-Vosseler
St. 22527 Hamburg, Germany, and the endoscope system may be a
conventional endoscope system such as a console including a
EPK-1000 video processor and a SONY LMD-2140MD medical grade flat
panel LCD monitor, all commercially available from Pentax Europe
GmbH, 104 Julius-Vosseler St., 22527 Hamburg, Germany.
[0070] As distinct from a conventional endoscope, the endoscope 100
has an outer sheath 101 which is preferably provided with at least
one balloon inflation/deflation aperture 102, with which is
associated a fluid flow discriminator such as a filter 104,
preferably a gas permeable, liquid impermeable filter, for example
a Polytetrafluoroethylene filter, such as a Polytetrafluoroethylene
filer sheath forming part of Hydrophobic Filter product P/N 28211,
commercially available from Qosina Inc., 150-Q Executive Drive
Edgewood, N.Y. 11717-8329 USA. Aperture 102 preferably communicates
with an interior volume 106 of the endoscope 100, which in
conventional endoscopes is sealed from the exterior other than via
a leak test port 108 at a rearward portion 110 of the endoscope. In
accordance with a preferred embodiment of the present invention,
interior volume 106 generally fills the interior of the endoscope
100.
[0071] Alternatively, depending on the configuration of the
endoscope, the leak test port 108 need not be located as
illustrated in FIGS. 1A & 1B but may be at a different
location.
[0072] Alternatively one or more aperture 102 and filter 104 may be
provided in the absence of a balloon for other applications such as
insufflation of a body cavity, such as an intestine, by
pressurizing the interior volume 106 of the endoscope via leak test
port 108 and one or more aperture 102 and filter 104.
[0073] Alternatively, as not shown, aperture 102 and filter 104 may
communicate with a fluid flow passageway other than interior volume
106, such as, for example, a fluid or other conduit, such as
conventional dedicated balloon inflation/deflation channels, which
are not known to be associated with filters at a forward portion
thereof.
[0074] As in conventional endoscopes, endoscope 100 includes,
forward of rearward portion 110, an insertion tube portion 112 and,
at a forward portion of endoscope 100, a bending section 114. In
the embodiment of FIGS. 1A & 1B aperture 102 and filter 104 are
located in the bending section 114 of endoscope 100.
[0075] Rearward portion 110 preferably includes, in addition to
leak test port 108, an instrument channel port 120, which
communicates with an instrument channel 122, extending throughout
the length of endoscope 100. Rearward portion 110 preferably also
includes conventional user interface elements, such as steering
knobs 124 and 126 and other elements (not shown) and defines an
interior volume, which forms part of interior volume 106 and
communicates with the leak test port 108.
[0076] Insertion tube portion 112 includes a reinforcement mesh 132
which serves to maintain the interior volume thereof against
collapse during bending thereof so as to maintain communication
therethrough between the interior volume of the rearward portion
110 and the interior volume of the bending section 114. A tubular
sealing sheath 134, typically forming part of outer sheath 101,
seals the interior volume of insertion tube portion 112 from the
exterior of the endoscope. In addition to the instrument channel
122, an optical fiber bundle 136 also extends through the interior
volume of the insertion tube portion 112. Other conduits and other
elements may also extend through this interior volume.
[0077] It is appreciated that interior volume 106 substantially
fills the interior of endoscope 100 which is not occupied by
conduits and other elements extending therethrough. Interior volume
106 is fluid sealed from the exterior of the endoscope 100
preferably other than via leak test port 108. Accordingly, it is a
particular feature of the present invention that interior volume
106 may be used, as not previously contemplated, for inflation and
deflation of an endoscope balloon.
[0078] It is further appreciated that notwithstanding the fact that
various conduits may extend through the interior volume 106, their
presence does not result in fluid communication between the
interior volume 106 and the interior of any conduit extending
therethrough.
[0079] Bending section 114 includes a selectably bendable
reinforcement mesh 142 which is selectably bendable in response to
operator manipulation of steering knobs 124 and 126. The interior
volume of bending section 114 is thus also protected against
collapse during bending thereof so as to maintain communication
therethrough with the interior volumes of the insertion tube
portion 112 and of the rearward portion 110. A tubular sealing
bending rubber sheath 144, typically forming part of outer sheath
101, seals the interior volume of bending section 114 from the
exterior of the endoscope. Bending rubber sheath 144 may be an
off-the-shelf product, such as a silicone bending rubber sheath
part number SPRBSS11, PVC bending rubber sheath part number
SPRBSP11, or a Viton bending rubber sheath part number SPRBSV11,
all commercially available from Endoscope Repair Inc. of 5201 Blue
Lagoon Drive, No. 815 Miami, Fla. 33126 USA. Instrument channel
122, optical fiber bundle 136 and optionally other elements extend
through the interior volume of the bending section 114.
[0080] In accordance with a preferred embodiment of the present
invention, bending section 114 includes a rigid collar element 150,
preferably formed of metal, which underlies a forward end 151 of
tubular sealing sheath 134 which is butted against a rearward end
of sheath 144. A rearward end 152 of an inflatable tubular balloon
154 is retained over rearward end of sheath 144 preferably by a
wire 156 wound thereabout. The rearward end 152 of balloon 154 is
preferably additionally sealed to sheath 144 by an adhesive 158,
such as a medical grade epoxy M31-CL, commercially available from
Henkel Corporation, One Henkel Way Rocky Hill, Conn. 06067,
USA.
[0081] Further in accordance with a preferred embodiment of the
present invention, bending section 114 includes a rigid tip portion
170, preferably formed of metal or plastic, a rearward portion 172
of which underlies a forward end 174 of sheath 144. A forward end
176 of inflatable tubular balloon 154 is retained over forward end
174 of sheath 144 preferably by a wire 178 wound thereabout. The
forward end 176 of balloon 154 is preferably additionally sealed to
rigid tip portion 170 by an adhesive 180, such as a medical grade
epoxy M31-CL, commercially available from Henkel Corporation, One
Henkel Way Rocky Hill, Conn. 06067, USA.
[0082] Filter 104 is preferably connected to sheath 144 underlying
aperture 102 by any suitable technique, such as the use of
adhesive, for example a Polychloroprene based Contact Cement
commercially available from Elmer's Products Inc. of One Easton
Oval Columbus, Ohio 43219, USA, may be used. It is appreciated that
a gas communication path extends between the leak test port 108 via
the interior volume 106, filter 104 and aperture 102 to a balloon
volume at the interior of inflatable/deflatable balloon 154.
[0083] It is a particular feature of the present invention that
inflatable/deflatable balloon 154 is inflated and/or deflated via
the interior volume 106 of the balloon endoscope 100. The available
cross section of the interior volume 106 for inflation/deflation of
the balloon 154 is typically 15-25 square millimeter, which is
approximately 6-15 times greater than the cross section of balloon
inflation channels employed in the prior art. This enables
inflation and deflation of the balloon 154 to take place
significantly faster than in prior art balloon endoscopes.
[0084] It is appreciated that the present invention enables
retrofit of existing non-balloon endoscopes to become balloon
endoscopes, without the complications and per treatment costs
associated with conventional external balloon devices. These
complications include limitations on bendability, torqueability and
maneuverability as well as increased cross section and increased
endoscope head resistance to advancement. Prior art balloon
endoscopes have increased per treatment costs arising from
difficulties in reprocessing, cleaning and disinfection thereof,
resulting in single-use components, which are obviated in the
operation of the present invention.
[0085] As seen in FIGS. 1A & 1B, the configuration of
inflatable/deflatable balloon 154 is preferably as shown at A,
characterized as follows:
[0086] Balloon 154 preferably has an overall length of 70-130 mm,
more preferably 90-110 mm. Rearward and forward ends 152 and 176
respectively of balloon 154 are generally cylindrical and have a
fixed inner cross-sectional radius R1, when forming part of balloon
endoscope 100. R1 is preferably between 4 and 7 mm so as to tightly
engage the adjacent portions of the endoscope.
[0087] A central cylindrical portion 182 of balloon 154 typically
has a length of 25-70 mm and more preferably 30-55 mm and has a
fixed inner cross-sectional radius R2, when inflated to a nominal
pressure, such as 10-20 millibars in excess of atmospheric
pressure. R2 is preferably between 20 and 35 mm depending on the
application.
[0088] Extending between the central cylindrical portion 182 and
each of the rearward and forward ends 152 and 176 respectively are
circularly symmetric tapered portions whose inner radius changes
from R2 to R1 preferably in accordance with the following
function:
cos(Alpha).gtoreq.r/R2
where r is the inner radius of the balloon at a given location
between the central cylindrical portion 182 and one of ends 152 and
176; and
[0089] Alpha is the angle between the tangent to the balloon at the
given location and a longitudinal axis of symmetry of the balloon,
here indicated by reference numeral 184.
[0090] More preferably, cos(Alpha) is approximately equal to
r/R2.
[0091] It is appreciated that the foregoing balloon configuration
is applicable not only to balloon endoscopes but also to balloon
catheters, with suitable adjustment being made to R1 and R2.
[0092] Alternatively other balloon configurations may be employed,
such as that shown at B.
[0093] As also seen in FIGS. 1A & 1B, the inflatable/deflatable
balloon 154 may be fixed to the endoscope as described hereinabove
and shown at A. Alternatively, the inflatable/deflatable balloon
154 may be removably attached to the endoscope as by stretchable
rings 188, as shown at B.
[0094] As additionally seen in FIGS. 1A & 1B, a single aperture
102 may be provided for gas communication between the interior of
inflatable/deflatable balloon 154 and the interior volume 106 of
endoscope 100 as described hereinabove and shown at A and B.
Alternatively, plural apertures 102, having associated therewith
plural filters 104 may be provided for gas communication between
the interior of inflatable/deflatable balloon 154 and the interior
volume 106 of endoscope 100, as shown as C.
[0095] As further seen in FIGS. 1A & 1B, the length of balloon
154 is preferably approximately similar to the length of the
bending rubber sheath 144 and aligned therewith, as shown at A and
B. This alignment allows rearward end 152 of balloon 154 to be
mounted over the rigid collar element 150, by the wires 156 and
adhesive 158 as shown at A together with underlying rearward end of
sheath 144, or by removable ring 188 as shown at B, and allows
forward end 176 of balloon 154 to be mounted over the rigid
rearward portion 172 of rigid tip portion 170, by wires 178 and
adhesive 180 as shown at A together with underlying forward end 174
of sheath 144, or by removable ring 188 as shown at B.
[0096] Alternatively, as shown at C in FIGS. 1A & 1B, the
length of balloon 154 is shorter than the length of bending rubber
sheath 144, in which case end portions 152 and 176 of balloon 154
may be fixed to the bending rubber sheath 144 by any suitable known
technique, such as by adhesive or by ultrasonic welding.
[0097] It is a particular feature of the present invention that an
inflation/deflation control system 190 is coupled to the interior
volume 106 of the endoscope 100 via leak test port 108.
[0098] Reference is now made to FIGS. 2A & 2B, which illustrate
a second embodiment of a balloon endoscope constructed and
operative in accordance with the present invention. As seen in
FIGS. 2A & 2B, an endoscope 200 is connected to an endoscope
system (not shown). Other than as specifically described
hereinbelow, the endoscope 200 may be a conventional endoscope such
as an EC-3470LK video colonoscope or a VSB-3430K video enteroscope
which are commercially available from Pentax Europe GmbH, 104
Julius-Vosseler St. 22527 Hamburg, Germany, and the endoscope
system may be a conventional endoscope system such as a console
including a EPK-1000 video processor and a SONY LMD-2140MD medical
grade flat panel LCD monitor, all commercially available from
Pentax Europe GmbH, 104 Julius-Vosseler St., 22527 Hamburg,
Germany.
[0099] An interior volume 206 of the endoscope 200, which
preferably generally fills the interior of the endoscope 200, is
sealed from the exterior other than via a leak test port 208 at a
rearward portion 210 of the endoscope 200.
[0100] As in conventional endoscopes, endoscope 200 includes,
forward of rearward portion 210, an insertion tube portion 212 and,
at a forward portion of endoscope 200, a bending section 214.
[0101] Rearward portion 210 preferably includes, in addition to
leak test port 208, an instrument channel port 220, which
communicates with an instrument channel 222, extending throughout
the length of endoscope 200. Rearward portion 210 preferably also
includes conventional user interface elements, such as steering
knobs 224 and 226 and other elements (not shown) and defines an
interior volume, which forms part of interior volume 206 and
communicates with the leak test port 208.
[0102] Insertion tube portion 212 includes a reinforcement mesh 232
which serves to maintain the interior volume thereof against
collapse during bending thereof so as to maintain communication
therethrough between the interior volume of the rearward portion
and the interior volume of the bending section 214. A tubular
sealing sheath 234 seals the interior volume of insertion tube
portion 212 from the exterior of the endoscope. In addition to the
instrument channel 222, an optical fiber bundle 236 also extends
through the interior volume of the insertion tube portion 212.
Other conduits and elements may also extend through this interior
volume.
[0103] Bending section 214 includes a selectably bendable
reinforcement mesh 242 which is selectably bendable in response to
operator manipulation of steering knobs 224 and 226. The interior
volume of bending section 214 is thus also protected against
collapse during bending thereof so as to maintain communication
therethrough with the interior volumes of the insertion tube
portion 212 and of the rearward portion 210.
[0104] A tubular sealing bending rubber sheath 244 seals the
interior volume of bending section 214 from the exterior of the
endoscope. Instrument channel 222, an optical fiber bundle 236 and
optionally other elements and conduits extend through the interior
volume 246 of the bending section 214.
[0105] As distinct from a conventional endoscope, tubular sealing
bending rubber sheath 244 includes an integrally formed selectably
inflatable/deflatable balloon portion 248, the interior of which
communicates with the interior volume 246 of the bending section
214. Bending rubber sheath 244 with balloon portion 248 may be made
of a generally stretchable material such as silicon, or a
relatively non-stretchable material such as PVC, polyurethane,
nylon or other polymeric material.
[0106] In accordance with a preferred embodiment of the present
invention, bending section 214 includes a rigid collar element 250,
preferably formed of metal, which underlies a forward end 251 of
tubular sealing sheath 234 which is butted against a rearward end
of sheath 244.
[0107] A fluid flow discriminator such as an in-line filter 252,
preferably a gas permeable, liquid impermeable filter, for example
a Polytetrafluoroethylene filer, such as a Polytetrafluoroethylene
filer sheath forming part of Hydrophobic Filter product P/N 28211,
commercially available from Qosina Inc., 150-Q Executive Drive
Edgewood, N.Y. 11717-8329 USA, is disposed within rigid collar
element 250 and prevents liquid from passing between the interior
volume 246 of the bending section 214 and the interior volume 206
of the remainder of the endoscope rearwardly thereof. It is
appreciated that a gas communication path extends between the leak
test port 208 via the interior volume 206, filter 252 and interior
volume 246 to the interior of inflatable/deflatable balloon portion
248.
[0108] Alternatively, as not shown, the interior of integrally
formed balloon portion 248 and filter 252 may communicate with a
fluid flow passageway other than interior volume 206, such as, for
example, a fluid or other conduit, such as conventional dedicated
balloon inflation/deflation channels, which are not known to be
associated with filters at a forward portion thereof.
[0109] A rearward end 253 of tubular sealing bending rubber sheath
244 is retained over rigid collar element 250 preferably by a wire
256 wound thereabout. The rearward end 253 of tubular sealing
bending rubber sheath 244 is preferably additionally sealed to
sheath 234 by an adhesive 258, such as a medical grade epoxy
M31-CL, commercially available from Henkel Corporation, One Henkel
Way Rocky Hill, Conn. 06067, USA.
[0110] Further in accordance with a preferred embodiment of the
present invention, bending section 214 includes a rigid tip portion
270, preferably formed of metal or plastic, a rearward portion 272
of which underlies a forward end 274 of sheath 244. Forward end 274
of sheath 244 is retained over rearward portion 272 of rigid tip
portion 270 preferably by a wire 278 wound thereabout. The forward
end 274 of sheath 244 is preferably additionally sealed to rigid
tip portion 270 by an adhesive 280, such as a medical grade epoxy
M31-CL, commercially available from Henkel Corporation, One Henkel
Way Rocky Hill, Conn. 06067, USA.
[0111] It is a particular feature of the present invention that an
inflation/deflation control system 290 is coupled to the interior
volume 206 of the endoscope 200 via leak test port 208.
[0112] Reference is now made to FIGS. 3A & 3B, which illustrate
a third embodiment of a balloon endoscope constructed and operative
in accordance with the present invention. As seen in FIGS. 3A &
3B, an endoscope 300 is connected to an endoscope system (not
shown). Other than as specifically described hereinbelow, the
endoscope 300 may be a conventional endoscope such as an EC-3470LK
video colonoscope or a VSB-3430K video enteroscope which are
commercially available from Pentax Europe GmbH, 104 Julius-Vosseler
St. 22527 Hamburg, Germany, and the endoscope system may be a
conventional endoscope system such as a console including a
EPK-1000 video processor and a SONY LMD-2140MD medical grade flat
panel LCD monitor, all commercially available from Pentax Europe
GmbH, 104 Julius-Vosseler St., 22527 Hamburg, Germany.
[0113] As distinct from a conventional endoscope, the endoscope 300
preferably includes an outer sheath 301 which is preferably
provided with at least one balloon inflation/deflation aperture
302, with which is associated a fluid flow discriminator such as a
filter 304, preferably a gas permeable, liquid impermeable filter,
for example a Polytetrafluoroethylene filer, such as a
Polytetrafluoroethylene filer sheath forming part of Hydrophobic
Filter product P/N 28211, commercially available from Qosina Inc.,
150-Q Executive Drive Edgewood, N.Y. 11717-8329 USA. Aperture 302
communicates with an interior volume 306 of the endoscope, which in
conventional endoscopes is sealed from the exterior other than via
a leak test port 308 at a rearward portion 310 of the
endoscope.
[0114] Alternatively, as not shown, aperture 302 and filter 304 may
communicate with a fluid flow passageway other than interior volume
306, such as, for example, a fluid or other conduit, such as
conventional dedicated balloon inflation/deflation channels, which
are not known to be associated with filters at a forward portion
thereof.
[0115] In accordance with a preferred embodiment of the present
invention, interior volume 306 generally fills the interior of the
endoscope 300.
[0116] As in conventional endoscopes, endoscope 300 includes,
forward of rearward portion 310, an insertion tube portion 312 and,
at a forward portion of endoscope 300, a bending section 314.
Aperture 302 and filter 304 are located in the insertion tube
portion 312 of endoscope 300.
[0117] Rearward portion 310 preferably includes, in addition to
leak test port 308, an instrument channel port 320, which
communicates with an instrument channel 322, extending throughout
the length of endoscope 300. Rearward portion 310 preferably also
includes conventional user interface elements, such as steering
knobs 324 and 326 and other elements (not shown) and defines an
interior volume, which forms part of interior volume 306 and
communicates with the leak test port 308.
[0118] Insertion tube portion 312 includes a reinforcement mesh 332
which serves to maintain the interior volume thereof against
collapse during bending thereof so as to maintain communication
therethrough between the interior volume of the rearward portion
and the interior volume of the bending section 314. A tubular
sealing sheath 334, typically forming part of outer sheath 301,
seals the interior volume of insertion tube portion 312 from the
exterior of the endoscope. In addition to the instrument channel
322, an optical fiber bundle 336 also extends through the interior
volume of the insertion tube portion 312. Other conduits and
elements may also extend through this interior volume.
[0119] Bending section 314 includes a selectably bendable
reinforcement mesh 342 which is selectably bendable in response to
operator manipulation of steering knobs 324 and 326. The interior
volume of bending section 314 is thus also protected against
collapse during bending thereof so as to maintain communication
therethrough with the interior volumes of the insertion tube
portion 312 and of the rearward portion 310. A tubular sealing
bending rubber sheath 344, typically forming part of outer sheath
301, seals the interior volume of bending section 314 from the
exterior of the endoscope. Bending rubber sheath 144 may be an
off-the-shelf product, such as a silicone bending rubber sheath
part number SPRBSS11, PVC bending rubber sheath part number
SPRBSP11, or a Viton bending rubber sheath part number SPRBSV11,
all commercially available from Endoscope Repair Inc. of 5201 Blue
Lagoon Drive, No. 815 Miami, Fla. 33126 USA.
[0120] Instrument channel 322, an optical fiber bundle 336 and
optionally other conduits and elements extend through the interior
volume of the bending section 314.
[0121] In accordance with a preferred embodiment of the present
invention, bending section 314 includes a rigid collar element 350,
preferably formed of metal, which underlies a forward end 351 of
tubular sealing sheath 334 which is butted against a rearward end
of sheath 344.
[0122] An inflatable tubular balloon 354 is sealingly mounted over
tubular sealing sheath 334 of insertion tube portion 312, overlying
aperture 302 and filter 304 as by any suitable technique such as
ultrasonic welding or an adhesive 358.
[0123] Further in accordance with a preferred embodiment of the
present invention, bending section 314 includes a rigid tip portion
370, preferably formed of metal or plastic, a rearward portion 372
of which underlies a forward end 374 of sheath 344.
[0124] Filter 304 is preferably connected to sheath 334 underlying
aperture 302 by any suitable technique, such as the use of
adhesive. It is appreciated that a gas communication path extends
between the leak test port 308 via the interior volume 306, filter
304 and aperture 302 to the interior of inflatable/deflatable
balloon 354.
[0125] It is a particular feature of the present invention that an
inflation/deflation control system 376 is coupled to the interior
volume 306 of the endoscope 300 via leak test port 308.
[0126] Reference is now made to FIG. 4, which is a simplified
illustration of an inflation/deflation control system 380 useful in
the balloon endoscopes of FIGS. 1A-3B.
[0127] As seen in FIG. 4, the inflation/deflation control system
380 preferably includes a pressure pump 382 and a vacuum pump 384,
which are preferably at least partially controlled by a
computerized control sub-system 386 having associated therewith a
user interface 388, preferably including buttons and visually
sensible indicators. Preferably pressure pump 382 and vacuum pump
384 are each connectable to a leak test port of a balloon
endoscope, such as that shown in FIGS. 1A-3B (not shown in FIG. 4)
via a manifold 390 and a flow meter 391. A pressure sensor 392 and
a pressure valve 394 are preferably connected in series between the
pressure pump 382 and manifold 390. A vacuum sensor 395 and a
vacuum valve 396 are preferably connected in series between the
vacuum pump 384 and manifold 390.
[0128] The computerized control sub-system 386 preferably includes
initialization module 397, preferably operative prior to insertion
of the balloon endoscope into a body cavity; and a real time leak
monitoring balloon inflation module 398 and a real time leak
monitoring balloon deflation module 399, both preferably operative
when the balloon endoscope is inserted at a desired location in a
body cavity.
[0129] The initialization module 397, which is preferably
automatically operated upon turning on the inflation/deflation
control system 380 preferably has the following functionality:
[0130] balloon endoscope pressurization producing balloon
inflation; [0131] pressure leak test when balloon endoscope is in a
pressurized state and the balloon is surrounded by a balloon
confining, gas permeable collar member; [0132] balloon endoscope
depressurization producing balloon deflation; [0133] vacuum leak
test when balloon endoscope is in a depressurized state; and [0134]
provision of system go/no go indication to the operator.
[0135] The real time leak monitoring balloon inflation module 398,
which is preferably actuated by the operator following insertion of
the balloon endoscope to a desired location within a body cavity,
preferably has the following functionality: [0136] balloon
endoscope pressurization producing balloon inflation; [0137]
provision of complete balloon inflation indication to the operator;
[0138] periodical positive pressure leak test when balloon
endoscope is in a pressurized state within a body cavity such as
the intestine; and [0139] provision of leak indication to the
operator.
[0140] The real time leak monitoring balloon deflation module 399,
which is preferably actuated by the operator following insertion of
the balloon endoscope to a desired location within a body cavity,
preferably has the following functionality: [0141] balloon
endoscope depressurization producing balloon deflation; [0142]
provision of complete balloon deflation indication to the operator;
[0143] periodical negative pressure leak test when balloon
endoscope is in a depressurized state within a body cavity such as
the intestine; and [0144] provision of leak indication to the
operator.
[0145] It is a particular feature of the present invention that the
real time leak monitoring balloon inflation module 398 is
responsive to an output from the flow meter 391 in order to
distinguish between a sensed pressure drop at the interior of the
endoscope which results from a change in the effective volume of
the intestine during a procedure and a sensed pressure drop at the
interior of the endoscope which results from a leak. By monitoring
the total flow to the interior of the balloon endoscope and noting
the total volume of the inflated balloon and the interior of the
endoscope, a sensed pressure drop combined with an indication of
fluid flow which exceeds this total volume indicates the presence
of a leak.
[0146] It is appreciated that the functionality of modules 398 and
399 has utility even in the absence of a balloon, where the
interior of the endoscope is sealed from the exterior thereof
during operation thereof, such as in otherwise conventional
endoscopes wherein automatic real time leak testing of the interior
volume of the endoscope during operation of the endoscope is highly
desirable.
[0147] Reference is now made to FIGS. 5A-5J, which are together a
simplified pictorial flowchart which illustrates operation of a
balloon endoscope in accordance with a preferred embodiment of the
present invention.
[0148] As seen in FIG. 5A, there is provided a balloon endoscope
constructed and operative in accordance with a preferred embodiment
of the invention, such as any one of the embodiments of an
endoscope described hereinabove, and in particular for the
illustrated example of FIGS. 5A-5J, the endoscope shown at A in
FIGS. 1A & 1B. For the sake of convenience and conciseness, the
reference numerals used in conjunction with FIGS. 1A & 1B are
employed throughout the description of FIGS. 5A-5J.
[0149] Preferably prior to beginning endoscopy treatments each day,
a manual leak test is performed on the endoscope 100 using a
conventional endoscope leak tester 402, such as a model PLT-5500,
commercially available from Instrument Specialists Inc., 32390
IH-10 West, Boerne, Tex. 78006-9214, USA, and a balloon confining,
gas permeable collar member 404 which allows gas to escape from a
leaky balloon but limits expansion thereof.
[0150] As seen in FIG. 5B, the leak tester 402 is operatively
connected to the leak test port 108 of the balloon endoscope 100
and the collar 404 is placed over the balloon 154 of the balloon
endoscope 100. Using the leak tester 402, positive pressure is
applied via the test port 108 and the interior volume 106 of the
balloon endoscope 100 in order to pressurize and inflate the
balloon 154. The pressure within the interior volume 106 is
visually monitored to detect any pressure decrease over time which
would indicate a rupture in the balloon 154 or elsewhere in the
endoscope 100 which would permit fluid communication between the
exterior of the endoscope 100 and its interior volume 106.
[0151] Upon successful completion of the leak test, the leak tester
402 and the collar 404 are detached from the endoscope 100, which
is ready for clinical use.
[0152] Reference is now made to FIG. 5C, which illustrates a novel
further leak test performed in a clinical setting just prior to
insertion of the endoscope 100 into a body cavity. As indicated in
FIG. 5C, collar 404 is placed over balloon 154 and
inflation/deflation control system 190 is coupled to the interior
volume 106 of the endoscope 100 via leak test port 108. The
operator initiates an automatic Clinical Integrity Test Protocol
(CITP) preferably by actuating a CITP button 406.
[0153] The Clinical Integrity Test Protocol preferably includes,
inter alia, (a) a leak test during balloon inflation and (b) a
subsequent leak test during application of vacuum to the balloon.
Preferably, upon successful completion of the Clinical Integrity
Test Protocol, a visual indication is automatically provided to the
operator, such as by illumination of an indicator light 408.
[0154] Immediately following successful completion of the CITP
protocol, as shown in FIG. 5D, the endoscope 100 may be inserted,
with balloon 154 in a deflated state, into a body cavity, such as a
patient's intestine and advanced to a location 410 therein at which
it is desired to inflate balloon 154.
[0155] While balloon 154 is still in a deflated state, module 399
is automatically operative to provide periodic leak testing of
balloon 154 and the interior volume 106 of endoscope 100, while the
endoscope is in a body cavity.
[0156] The balloon 154 is then inflated at location 410, as shown
in FIG. 5E by supplying pressurized gas via the leak test port 108
and the interior volume 106 of the endoscope 100 to the interior of
the balloon 154. While balloon 154 is in an inflated state, module
398 is automatically operative to provide periodic leak testing of
balloon 154 and the interior volume 106 of endoscope 100, while the
endoscope is in a body cavity.
[0157] Inflation of balloon 154 is preferably operative to anchor
the balloon endoscope and thereby to spatially stabilize the
endoscope 100 in the intestine and allow various diagnostic and/or
therapeutic procedures to be carried out using conventional
endoscope tools and techniques as indicated, for example in FIG.
5F. Examples of diagnostic and/or therapeutic procedures which are
advantageously carried out using the balloon endoscope 100 include
removal of polyps, as shown in FIG. 5F, performing biopsies,
dilating strictures, suturing, stapling and clipping. Following
completion of the diagnostic and/or therapeutic procedures, the
endoscope tools may be removed and the balloon 154 may be deflated
to allow advancement or retraction of the endoscope.
[0158] A two-balloon technique, such as that illustrated in FIGS.
5G & 5H may be employed in order to facilitate advancement of
the balloon endoscope in the intestine. Conventional two-balloon
endoscope advancement is known, and described in details for
example in applicant's copending PCT Application No.
PCT/IL2005/000152, filed Feb. 7, 2005; PCT Application No.
PCT/IL2005/000849, filed Aug. 8, 2005; PCT Application No.
PCT/IL2007/000600, filed May 17, 2007; and in US patent application
publication No. US 2005/0171400. FIGS. 5G & 5H show the
provision of a second inflation/deflation control system 420, which
may be identical in structure and function to inflation/deflation
control system 380 (FIG. 4) and is also useful with the balloon
endoscopes of FIGS. 1A-3B.
[0159] Second inflation/deflation control system 420 preferably
includes an initialization module (not shown), similar or identical
to initialization module 397 of inflation/deflation control system
380, preferably operative prior to insertion of the balloon
endoscope into a body cavity. Second inflation/deflation control
system 420 preferably also includes a real time leak monitoring
balloon inflation module 428, similar or identical to real time
leak monitoring balloon inflation module 398 of inflation/deflation
control system 380 and a real time leak monitoring balloon
deflation module 429, similar or identical to real time leak
monitoring balloon deflation module 399, of inflation/deflation
control system 380.
[0160] Second inflation/deflation control system 420 preferably
communicates with an endoscope tool balloon 440 mounted on a
flexible tube 442 of an endoscope tool 444. In two-balloon
endoscope advancement, endoscope tool balloon 440 is operated
preferably using the protocol described above with reference to
FIGS. 4 and 5C. More specifically, a novel further leak test is
performed in a clinical setting just prior to insertion of the
endoscope tool 444 into instrument channel 122 of endoscope
100.
[0161] The operator initiates an automatic Clinical Integrity Test
Protocol (CITP) preferably by actuating a CITP button 456.
[0162] The Clinical Integrity Test Protocol preferably includes,
inter alia, (a) a leak test during balloon inflation and (b) a
subsequent leak test during application of vacuum to the balloon.
Preferably, upon successful completion of the Clinical Integrity
Test Protocol, a visual indication is automatically provided to the
operator, such as by illumination of an indicator light 458.
[0163] Immediately following successful completion of the CITP
protocol, the endoscope tool 444 may be inserted through the
instrument channel 122 in a deflated state and thereafter inflated
forward of the endoscope 100, as shown in FIG. 5G.
[0164] While balloon 440 is still in a deflated state, module 429
is automatically operative to provide periodic leak testing of
balloon 440 while the endoscope is in a body cavity.
[0165] While balloon 440 is an inflated state, as shown in FIG. 5G,
module 428 is automatically operative to provide periodic leak
testing of balloon 440, while the endoscope 100 and the balloon 440
are in a body cavity.
[0166] It is appreciated that while balloon 154 and endoscope 100
are in the body cavity, periodic leak testing thereof continues in
accordance with the protocols established by modules 398 and 399,
described above.
[0167] Stages of two-balloon advancement of the endoscope 100 are
illustrated in FIGS. 5G and 5H, employing balloons 154 and 440.
Thereafter, additional two-balloon advancement steps may take
place. Following each advancement step, balloon 440 may be deflated
as shown in FIG. 5H. While balloon 440 is still in a deflated
state, module 429 is automatically operative to provide periodic
leak testing of balloon 440. Once tool 444 is no longer required,
it may be removed via the instrument channel 122, when balloon 440
is in a deflated state.
[0168] FIG. 5I shows removal of the balloon endoscope 100 from the
patient body cavity, with balloon 154 in a deflated state. While
balloon 154 is still in a deflated state, module 399 is
automatically operative to provide periodic leak testing of balloon
154 and the interior volume 106 of endoscope 100, while the
endoscope is in a body cavity.
[0169] FIG. 5J illustrates reprocessing, including cleaning of the
balloon endoscope 100 following use thereof. Manual cleaning of
balloon 154 while inflated is shown at A and machine cleaning of
the balloon 154 within a liquid spray permeable inflation limiting
collar 460 is shown at B. In both cases, the balloon 154 is
preferably inflated via leak test port 108 and then sealed in an
inflated state for cleaning, as by a stopcock 462.
[0170] Reference is now made to FIGS. 6A-6J, which are simplified
pictorial illustrations of a method of manufacture of a balloon
endoscope in accordance with a preferred embodiment of the present
invention.
[0171] A conventional non-balloon endoscope 500 such as an
EC-3470LK video colonoscope or a VSB-3430K video enteroscope which
are commercially available from Pentax Europe GmbH, 104
Julius-Vosseler St. 22527 Hamburg, Germany, may be provided.
[0172] Alternatively, an endoscope of a different manufacturer may
be employed. In such a case, a leak test port may be located at
various locations or may not be provided. In the former case, if
the location of the leak test port is not suitable, the existing
leak test port may be sealed and a new leak test port formed, as by
a retrofit procedure, at a suitable location in communication with
the interior volume of the endoscope. In the latter case, a leak
test port may be provided in communication with the interior volume
of the endoscope, as by a retrofit procedure.
[0173] The endoscope 500 may be retrofitted as a balloon endoscope
by initially removing a bending rubber sheath 502 therefrom, as
seen in FIGS. 6A & 6B. This is preferably accomplished by first
removing the epoxy-covered wound retaining wires 504 and 506 which
attach the sheath 502 to the remainder of the endoscope 500. As
shown in a simplified manner in FIG. 6A, this may be achieved by
first grinding down the epoxy and then cutting the wire using a
scalpel.
[0174] Thereafter, as shown in a simplified manner in FIG. 6B, the
bending rubber sheath 502 may then be slit using the scalpel and an
underlying protective plate inserted between the bending rubber
sheath 502 and the protective mesh 508 of the endoscope 500.
[0175] The result of the steps shown in FIGS. 6A and 6B is an
endoscope having an exposed bending section 510. Alternatively, an
endoscope may be initially constructed to have an exposed bending
section 510.
[0176] In a separate manufacturing sequence, an aperture 518 is
formed in a conventional bending rubber sheath 520, such as a
silicone bending rubber sheath part number SPRBSS11, PVC bending
rubber sheath part number SPRBSP11, or a Viton bending rubber
sheath part number SPRBSV11, all commercially available from
Endoscope Repair Inc. of 5201 Blue Lagoon Drive, No. 815 Miami,
Fla. 33126 USA, by any suitable technique, such as punching. A
filter element 522 is preferably adhered by an adhesive 524, such
as a Polychloroprene based Contact Cement commercially available
from Elmer's Products Inc. of One Easton Oval Columbus, Ohio 43219,
USA, to the interior of the bending rubber sheath 520 underlying
aperture 518, such as by the use of an inserter 526. A removable
fluid sealing patch 528 is preferably placed over the aperture 518
on the outside of the bending rubber sheath 520.
[0177] The resulting apertured, filter-equipped and sealed bending
rubber sheath assembly 530 is preferably inserted into a bending
rubber sheath placement tool 532. Tool 532 preferably includes a
cylinder 533 which is shorter than sheath assembly 530. The axial
ends 534 and 536 of sheath assembly 530 are preferably bent over
onto the corresponding axial ends 538 and 540 of tool 532, as shown
in FIG. 6D.
[0178] A vacuum port 542 communicates with the interior of the
cylinder 533 of tool 532. A vacuum is applied between the interior
of tool 532 and the exterior of sheath assembly 530 via vacuum port
542, thereby producing radial stretching of sheath assembly 530 and
resulting axial expansion thereof, as shown in FIG. 6D.
[0179] Turning now to FIG. 6E, it is seen that the endoscope having
an exposed bending section 510, (FIG. 6B) is inserted into the tool
532 holding the sheath assembly 530 under vacuum in a radially
expanded state (FIG. 6D), such that the rearward end 538 of tool
532 overlies a rigid collar element 550 of endoscope 500 and the
forward end 540 of tool 532 overlies a rearward portion 552 of a
rigid tip portion 554 of endoscope 500 as seen at A.
[0180] The vacuum is then released as shown at B, allowing part of
the bending rubber assembly 530 to collapse onto the reinforcement
mesh 508. As shown at C, the ends 534 and 536 of the bending rubber
assembly 530 are then rolled off corresponding ends 538 and 540 of
tool 532 and onto rigid collar element 550 and onto rearward
portion 552 of rigid tip portion 554 of endoscope 500,
respectively. As shown in FIG. 6F, the resulting partially
retrofitted endoscope 560 has rearwardly facing edge 564 of bending
rubber assembly 530 in butting relationship with a corresponding
forwardly facing edge 566 of a tubular sealing sheath 568 of
endoscope 560 as seen at A and a forwardly facing edge 570 of
bending rubber assembly 530 in butting relationship with a
corresponding rearwardly facing edge 572 of rigid tip portion 554
of endoscope 560, as shown at B.
[0181] As further seen in FIG. 6F, the tool 532 is slipped off of
the endoscope 500 and the patch 528 is removed.
[0182] Turning to FIG. 6G, it is seen that a balloon, preferably a
pre-shaped balloon 580 such as balloon 154 as described
hereinabove, is slipped over the bending rubber assembly 530 of
endoscope 500 such that the respective axial ends 582 and 584 of
balloon 580 are aligned with respective ends 534 and 536 of the
bending rubber assembly 530 and more particularly preferably such
that a rearwardly facing edge 588 of balloon 580 overlies
rearwardly facing edge 564 of bending rubber assembly 530 and a
forwardly facing edge 590 of balloon 580 overlies forwardly facing
edge 570 of bending rubber assembly 530.
[0183] As seen in FIG. 6H, wires 592 and 594 are tightly wound
about respective ends 582 and 584 of balloon 580. Thereafter, as
seen in FIG. 6I, the wound wires are preferably encased in epoxy
596 together with the respective butting edges 564 & 566 and
570 & 572 and corresponding ends 534 and 536 of bending rubber
assembly 530.
[0184] The steps shown particularly in FIGS. 6H and 6I provide
fluid sealing between the interior volume of the balloon 580 and
the exterior thereof and also provides fluid sealing between
respective ends 534 and 536 of the bending rubber assembly 530 and
rigid collar element 550 and rearward portion 552 of rigid tip
portion 554 of endoscope 500. The provision of epoxy 596
additionally provides fluid sealing between the respective butting
edges 564 & 566 and 570 & 572.
[0185] The result of the manufacturing steps shown in FIGS. 6A-6I
is a balloon endoscope constructed and operative in accordance with
a preferred embodiment of the present invention. A particular
feature of the present invention in both the retrofit and
non-retrofit balloon endoscopes is use of the interior volume of
the endoscope for balloon inflation and deflation. It is also a
particular feature of the present invention that retrofit of a
conventional endoscope as a balloon endoscope requires only
modification of the bending section of the endoscope.
[0186] It will be appreciated by persons skilled in the art that
the present invention is not limited by what has been particularly
shown and described herein above. Rather the scope of the present
invention includes both combinations and subcombinations of the
various features described hereinabove as well as variations and
modifications which would occur to persons skilled in the art upon
reading the specifications and which are not in the prior art.
* * * * *