U.S. patent application number 16/288164 was filed with the patent office on 2019-08-01 for assemblies for use with an endoscope.
The applicant listed for this patent is SMART MEDICAL SYSTEMS LTD.. Invention is credited to GILAD LURIA, ORI NISSAN, GAD TERLIUC.
Application Number | 20190231174 16/288164 |
Document ID | / |
Family ID | 41136005 |
Filed Date | 2019-08-01 |
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United States Patent
Application |
20190231174 |
Kind Code |
A1 |
TERLIUC; GAD ; et
al. |
August 1, 2019 |
ASSEMBLIES FOR USE WITH AN ENDOSCOPE
Abstract
Mounting a double-balloon auxiliary endoscope assembly over a
conventional endoscope by sliding an overtube subassembly over the
conventional endoscope, and thereafter sliding over the
conventional endoscope, while connected to the overtube subassembly
via a flexible interconnection tube, a forward balloon support
sleeve of a forward balloon subassembly also including a forward
balloon fixedly mounted on the forward balloon support sleeve and
defining together therewith a forward inflatable volume.
Inventors: |
TERLIUC; GAD; (RA'ANANA,
IL) ; LURIA; GILAD; (GIVATAYIM, IL) ; NISSAN;
ORI; (RAMAT GAN, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SMART MEDICAL SYSTEMS LTD. |
RA'ANANA |
|
IL |
|
|
Family ID: |
41136005 |
Appl. No.: |
16/288164 |
Filed: |
February 28, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14811003 |
Jul 28, 2015 |
10264951 |
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16288164 |
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12934775 |
Dec 10, 2010 |
9119532 |
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PCT/IL2009/000322 |
Mar 23, 2009 |
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14811003 |
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61064881 |
Mar 31, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 1/00131 20130101;
A61B 1/00082 20130101; A61B 1/00101 20130101; A61B 1/00135
20130101 |
International
Class: |
A61B 1/00 20060101
A61B001/00 |
Claims
1. A double-balloon auxiliary endoscope assembly suitable for use
with a conventional endoscope, said assembly comprising: a forward
balloon subassembly comprising: a forward balloon support sleeve
arranged for mounting in a fixed position over said conventional
endoscope and having a forward balloon support sleeve mounted,
forward balloon inflation lumen extending at least partially along
said forward balloon support sleeve; and a forward balloon mounted
on said forward balloon support sleeve and together therewith
defining a forward inflatable volume which is inflatable via said
forward balloon support sleeve mounted, forward balloon inflation
lumen; an overtube subassembly comprising: an overtube sleeve
arranged for slidable mounting over said conventional endoscope;
and an overtube balloon mounted on said overtube sleeve and
together therewith defining a rearward inflatable volume, and said
overtube sleeve having first and second lumens extending at least
partially therealong, said first lumen being an overtube mounted,
forward balloon inflation lumen, and said second lumen being an
overtube mounted, overtube balloon inflation lumen, said rearward
inflatable volume being inflatable via said overtube mounted,
overtube balloon inflation lumen; and an overtube rearward
displacement accommodating, flexible interconnection tube
interconnecting said forward balloon support sleeve mounted,
forward balloon inflation lumen and said overtube mounted, forward
balloon inflation lumen.
2. A double-balloon auxiliary endoscope assembly according to claim
1 and wherein said interconnection tube is selectably extendible by
being at least partially straightened.
3. A double-balloon auxiliary endoscope assembly according to claim
1 and also comprising a forward balloon inflation/deflation supply
and exhaust tube connected to said first lumen and an overtube
balloon inflation/deflation supply and exhaust tube connected to
said second lumen.
4. A double-balloon auxiliary endoscope assembly according to claim
1 and wherein said forward balloon support sleeve includes a
resilient collar.
5. A double-balloon auxiliary endoscope assembly according to claim
1 and wherein said forward balloon support sleeve includes a collar
which is adapted to fixedly mount said forward balloon support
sleeve onto endoscopes of varying outer diameter.
6. A method for mounting a double-balloon auxiliary endoscope
assembly over a conventional endoscope, the method comprising:
sliding an overtube subassembly over said conventional endoscope;
and thereafter sliding over said conventional endoscope, while
connected to said overtube subassembly via a flexible
interconnection tube, a forward balloon support sleeve of a forward
balloon subassembly also including a forward balloon fixedly
mounted on said forward balloon support sleeve and defining
together therewith a forward inflatable volume.
7. A method for mounting a double-balloon auxiliary endoscope
assembly over a conventional endoscope according to claim 6 and
also comprising: fixedly and removably mounting said forward
balloon support sleeve onto said conventional endoscope.
8. A method for mounting a double-balloon auxiliary endoscope
assembly over a conventional endoscope according to claim 6 and
also comprising initially stretching and then releasing a resilient
collar associated with said forward balloon support sleeve for
fixedly and removably mounting of said forward balloon support
sleeve onto said conventional endoscope.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 14/811,003, filed Jul. 28, 2015, entitled "ASSEMBLIES FOR
USE WITH AN ENDOSCOPE," which is a divisional of U.S. patent
application Ser. No. 12/934,775, filed Dec. 10, 2010, now U.S. Pat.
No. 9,119,532, issued Sep. 1, 2015, entitled "ASSEMBLIES FOR USE
WITH AN ENDOSCOPE," which is a National Phase Application of PCT
Application No. PCT/IL2009/000322, filed Mar. 23, 2009, which
claims priority form U.S. Provisional Patent Application Ser. No.
61/064,881, filed Mar. 31, 2008, entitled "DEVICE AND METHOD FOR
EXPANDABLE ELEMENT," the disclosure of which is hereby incorporated
by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to endoscope systems
generally.
BACKGROUND OF THE INVENTION
[0003] The following patent publications and commercially available
products are believed to represent the current state of the
art:
[0004] U.S. Pat. Nos. 4,040,413; 4,148,307; 4,195,637; 4,453,545;
4,676,228; 4,862,874; 5,025,778; 6,007,482; 6,309,346; 6,461,294;
6,585,639;
[0005] U.S. Patent Application publication Nos. 2004/0102681;
2005/0124856; 2005/0125005; 2005/0137457; 2005/0165273;
2006/0111610; 2006/0161044 and 2007/0244361;
[0006] Double Balloon Endoscope product, including EN-450T5
enteroscope, TS-13140 overtube and BS-2 front balloon, which
interface with balloon pump control BP-20 and 2200 video system,
all commercially available from Fujinon Inc., of 10 High Point
Drive, Wayne, N.J., USA; and
[0007] Sleeve Expander Tool product, manufactured by
HellermannTyton of 7930 N. Faulkner Road., Milwaukee, Wis. USA, and
commercially distributed in the UK by Canford Audio PLC of Crowther
Road, Washington, UK under catalog number 55-601.
SUMMARY OF THE INVENTION
[0008] The present invention seeks to provide improved assemblies
for operation with elongate articles such as endoscopes.
[0009] There is thus provided in accordance with a preferred
embodiment of the present invention an expander for mounting a
resilient outer tubular article over an elongate article including
a chassis element having associated therewith at least one
outwardly movable element which is selectably engageable with at
least a portion of the resilient outer tubular article, a driver
which is movable with respect to the chassis element and is
operative to selectably engage the at least one outwardly movable
element, when the outwardly movable element is in engagement with
the at least a portion of the resilient outer tubular article, for
producing corresponding outward motion and outward expansion
thereof and an engagement element, associated with the driver, for
insertion into the at least a portion of the resilient outer
tubular article upon expansion thereof by operation of the driver,
the engagement element being configured to accommodate at least a
portion of the elongate article.
[0010] In accordance with a preferred embodiment of the present
invention the expander also includes resilient outer tubular
article disengagement functionality operative for disengagement of
the at least a portion of the resilient outer tubular article from
the engagement element. Preferably, the disengagement functionality
is associated with the chassis element. Additionally or
alternatively, the disengagement functionality is operative for
sliding the at least a portion of the resilient outer tubular
article relative to the engagement element.
[0011] Preferably, the expander is operative for mounting the
resilient outer tubular article over the elongate article at a
generally predetermined distance from a forward end thereof.
Additionally or alternatively, the engagement element is removably
associated with the driver. Additionally or alternatively, the
engagement element is adapted for accommodating the at least a
portion of the elongate article up to a predetermined length
thereof. Preferably, the engagement element is generally smaller
then the chassis element. Yet preferably, the driver is axially
movable with respect to the chassis element.
[0012] There is also provided in accordance with another preferred
embodiment of the present invention a method for mounting a
resilient outer tubular article over an elongate article including
employing an expander which includes a chassis element which is
selectably engageable with at least one resilient portion of the
resilient outer tubular article, a driver which is movable with
respect to the chassis, and an engagement element configured to
accommodate at least a portion of the elongate article, to carry
out the functions of expanding the at least one resilient portion
of the resilient outer tubular article, followed by insertion of
the engagement element into the at least one resilient portion,
followed by engagement of the elongate article with the engagement
element, followed by disengagement of the engagement element from
the at least one resilient portion.
[0013] In accordance with a preferred embodiment of the present
invention, the method of mounting a resilient outer tubular article
over an elongate article also includes, following the insertion of
the engagement element into the at least one resilient portion, and
prior to engagement of the elongate article with the engagement
element, the step of disengagement of the engagement element from
the remainder of the expander. Additionally or alternatively, the
method also includes following the engagement of the elongate
article with the engagement element, and prior to the disengagement
of the engagement element from the at least one resilient portion,
the step of engagement of the engagement element with the remainder
of the expander. Additionally or alternatively, the disengagement
of the engagement element from the at least one resilient portion
includes sliding the engagement element relative to the at least
one resilient portion.
[0014] There is further provided in accordance with yet another
preferred embodiment of the present invention a hand-held collar
cutting tool for removal of an auxiliary endoscope assembly having
a resilient collar portion from an endoscope, the cutting tool
including a hand-held collar cutting tool body portion, a cutting
edge associated with the cutting tool body portion and adapted for
cutting the resilient collar portion, and a spacer portion
protruding from the hand-held collar cutting tool body portion, the
spacer portion being adapted for insertion between the resilient
collar portion and the endoscope for spacing the endoscope from the
resilient collar portion and from the cutting edge.
[0015] In accordance with a preferred embodiment of the present
invention, the spacer portion has an elongate, tapered shape.
Preferably, the spacer portion has varied flexibility along its
length. Additionally or alternatively, the spacer portion is softer
than an external surface of the endoscope.
[0016] There is also provided in accordance with still another
preferred embodiment of the present invention a method for removal
of an auxiliary endoscope assembly having a resilient collar
portion from an endoscope including employing a hand-held collar
cutting tool having a spacer portion and a cutting edge to perform
the sequential functions of inserting the spacer portion between
the resilient collar portion and the endoscope, thereby spacing the
resilient collar portion from the endoscope and spacing the
endoscope from the cutting edge, and bringing the cutting edge into
cutting engagement with the resilient collar portion when the
resilient collar portion and the cutting edge are both spaced from
the endoscope, thereby to prevent cutting damage to the
endoscope.
[0017] There is even further provided in accordance with still
another preferred embodiment of the present invention a
double-balloon auxiliary endoscope assembly suitable for use with a
conventional endoscope, the assembly including a forward balloon
subassembly including a forward balloon support sleeve arranged for
mounting in a fixed position over the conventional endoscope and
having a forward balloon support sleeve mounted, forward balloon
inflation lumen extending at least partially along the forward
balloon support sleeve, and a forward balloon mounted on the
forward balloon support sleeve and together therewith defining a
forward inflatable volume which is inflatable via the forward
balloon support sleeve mounted, forward balloon inflation lumen, an
overtube subassembly including an overtube sleeve arranged for
slidable mounting over the conventional endoscope, and an overtube
balloon mounted on the overtube sleeve and together therewith
defining a rearward inflatable volume, and the overtube sleeve
having first and second lumens extending at least partially
therealong, the first lumen being an overtube mounted, forward
balloon inflation lumen, and the second lumen being an overtube
mounted, overtube balloon inflation lumen, the rearward inflatable
volume being inflatable via the overtube mounted, overtube balloon
inflation lumen, and an overtube rearward displacement
accommodating, flexible interconnection tube interconnecting the
forward balloon support sleeve mounted, forward balloon inflation
lumen and the overtube mounted, forward balloon inflation
lumen.
[0018] Preferably, the interconnection tube is selectably
extendible by being at least partially straightened. Additionally
or alternatively, the double-balloon auxiliary endoscope assembly
also includes a forward balloon inflation/deflation supply and
exhaust tube connected to the first lumen and an overtube balloon
inflation/deflation supply and exhaust tube connected to the second
lumen. Additionally or alternatively, the forward balloon support
sleeve includes a resilient collar. Preferably, the forward balloon
support sleeve includes a collar which is adapted to fixedly mount
the forward balloon support sleeve onto endoscopes of varying outer
diameter.
[0019] There is also provided in accordance with another preferred
embodiment of the present invention a method for mounting a
double-balloon auxiliary endoscope assembly over a conventional
endoscope, the method including sliding an overtube subassembly
over the conventional endoscope, and thereafter sliding over the
conventional endoscope, while connected to the overtube subassembly
via a flexible interconnection tube, a forward balloon support
sleeve of a forward balloon subassembly also including a forward
balloon fixedly mounted on the forward balloon support sleeve and
defining together therewith a forward inflatable volume.
[0020] In accordance with a preferred embodiment of the present
invention, the method for mounting a double-balloon auxiliary
endoscope assembly over a conventional endoscope also includes
fixedly and removably mounting the forward balloon support sleeve
onto the conventional endoscope. Additionally or alternatively, the
method also includes initially stretching and then releasing a
resilient collar associated with the forward balloon support sleeve
for fixedly and removably mounting of the forward balloon support
sleeve onto the conventional endoscope.
[0021] There is further provided in accordance with yet another
embodiment of the present invention a wrap-around overtube which is
side-mountable onto an endoscope without access to an end of the
endoscope, the overtube including a generally cylindrical sleeve
having relatively high axial rigidity and relatively low radial
rigidity, the tube being formed with an expandable generally axial
slit, the sleeve being configured to permit circumferential
expansion of the slit to an extent sufficient to accommodate an
endoscope and subsequent circumferential contraction of the slit to
provide wrap-around mounting of the overtube onto the
endoscope.
[0022] Preferably, the sleeve is configured with respect to the
endoscope to permit slidable axial displacement of the sleeve along
the endoscope. Additionally or alternatively, the wrap-around
overtube also includes a wrap-around balloon mounted over at least
a portion of the sleeve, the wrap-around balloon being configured
for wrap-around mounting thereof onto the endoscope. Additionally
or alternatively, the wrap-around overtube also includes an
external tube extending at least partially along the sleeve, the
external tube being configured for passage of an endoscope tool
therethrough. Preferably, the external tube traverses the balloon.
Yet preferably, the external tube includes a low-friction lumen
through which the endoscope tool is slidably movable.
[0023] There is further provided in accordance with still another
preferred embodiment of the present invention a method for mounting
an overtube onto an endoscope without access to an end of the
endoscope, the method including providing a wrap-around overtube
having an expandable generally axial slit, expanding the generally
axial slit so as to accommodate the endoscope at a location spaced
from an end thereof, placing the overtube, with the generally axial
slit expanded, over the endoscope at a location spaced from an end
thereof, and at least partially closing the generally axial slit
thereby to retain the overtube over the endoscope at the location
spaced from the end thereof.
[0024] Preferably, the method also includes sliding displacement of
the overtube along the endoscope following at least partially
closing of the generally axial slit.
[0025] There is even further provided in accordance with still
another preferred embodiment of the present invention a wrap-around
balloon which is side-mountable onto an endoscope without access to
an end of the endoscope, the wrap-around balloon including a
generally cylindrical balloon being formed with an expandable
generally axial slit, the balloon being configured to permit
circumferential expansion of the slit to an extent sufficient to
accommodate an endoscope and subsequent circumferential contraction
of the slit to provide wrap-around mounting of the balloon onto the
endoscope.
[0026] There is also provided in accordance with yet another
preferred embodiment of the present invention a method for mounting
a balloon onto an endoscope without access to an end of the
endoscope, the method including providing a wrap-around balloon,
placing the wrap-around balloon over the endoscope at a location
spaced from an end thereof, and retaining the wrap-around balloon
over the endoscope.
[0027] There is further provided in accordance with still another
preferred embodiment of the present invention a slidable external
tube assembly for use with an endoscope, including an elongate tube
having a lumen, the lumen being configured for passage therethrough
of an endoscope tool, and at least one side-mountable element
configured for removably and slidably mounting the elongate tube
onto the endoscope without requiring access to an end of the
endoscope.
[0028] Preferably, the elongate tube and the at least one
side-mountable element are integrally formed as one piece.
[0029] There is also provided in accordance with another preferred
embodiment of the present invention a method for slidable mounting
of an external tube assembly onto an endoscope, including providing
an elongate tube having a lumen, the lumen being configured for
passage therethrough of an endoscope tool, employing at least one
side mountable element for removably and slidably mounting the
elongate tube onto the endoscope without requiring access to an end
of the endoscope, and sliding the elongate tube axially relative to
the endoscope.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The present invention will be understood and appreciated
from the following detailed description, taken in conjunction with
the drawings in which:
[0031] FIG. 1 is a simplified assembled view illustration of a
device for mounting an auxiliary endoscope assembly onto an
endoscope, constructed and operative in accordance with a preferred
embodiment of the present invention;
[0032] FIG. 2 is a simplified exploded view illustration of the
device for mounting an auxiliary endoscope assembly onto an
endoscope of FIG. 1;
[0033] FIGS. 3A, 3B, 3C and 3D are simplified illustrations of a
driver assembly forming part of the device of FIGS. 1 & 2;
[0034] FIGS. 4A, 4B, 4C, 4D and 4E are simplified illustrations of
a flange element forming part of the device of FIGS. 1 & 2;
[0035] FIGS. 5A, 5B and 5C are simplified illustrations of an arm
element forming part of the device of FIGS. 1 & 2;
[0036] FIGS. 6A, 6B, 6C, 6D, 6E and 6F are simplified illustrations
of an axially driven collar engagement element forming part of the
device of FIGS. 1 & 2;
[0037] FIGS. 7A, 7B, 7C, 7D, 7E, 7F, 7G, 7H, 7I, 7J, 7K, 7L, 7M,
7N, 7O, 7P and 7Q are simplified illustrations of various stages in
the operation of the device of FIGS. 1 & 2 for mounting an
auxiliary endoscope assembly onto an endoscope, and of various
stages in the operation of a collar cutting tool for cutting a
collar of an auxiliary endoscope assembly mounted on an
endoscope;
[0038] FIGS. 8A, 8B, 8C, 8D, 8E, 8F, 8G, 8H, 8I, 8J, 8K, 8L, 8M,
8N, 8O and 8P are sectional illustrations, taken along lines
VIII-VIII in FIGS. 1 and 7A-7P, in corresponding FIGS. 7A-7P;
[0039] FIG. 9 is a simplified, partially cut away, pictorial
illustration or a double balloon device, constructed and operative
in accordance with a preferred embodiment of the present invention,
which is suitable for mounting on a conventional endoscope;
[0040] FIG. 10 is a simplified pictorial illustration of the double
balloon device of FIG. 9, mounted on a conventional endoscope
assembly;
[0041] FIGS. 11A and 11B are simplified pictorial illustrations of
an endoscope overtube constructed and operative in accordance with
a preferred embodiment of the present invention in respective open
and closed orientations;
[0042] FIG. 12 is a simplified exploded pictorial illustration of
the endoscope overtube of FIGS. 11A & 11B;
[0043] FIGS. 13A, 13B and 13C are respective simplified pictorial,
end view and side view illustrations of a balloon employed in the
endoscope overtube of FIGS. 11A-12; and
[0044] FIGS. 14A, 14B, 14C, 14D and 14E are simplified
illustrations of association of the endoscope overtube of FIGS.
11A-12 with a conventional endoscope and a conventional endoscope
tool;
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0045] Reference is now made to FIGS. 1-6F, which illustrate a
device 100 for mounting an auxiliary device, having a resilient,
expandable collar portion, such as an auxiliary endoscope assembly
(shown in FIGS. 7A-8P) onto an endoscope (shown in FIGS. 7J-7L,
7O-7Q, and 8J-8P), constructed and operative in accordance with a
preferred embodiment of the present invention.
[0046] 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, the large intestine, arteries and veins. 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.
[0047] Referring generally to FIGS. 1 and 2, it is seen that device
100 preferably comprises a chassis element, such as a
hand-engageable element 102 (FIGS. 4A-4E) which is generally
symmetric about a longitudinal axis 104. A driver assembly 106
(FIGS. 3A-3D) is arranged for hand-driven displacement relative to
element 102 along longitudinal axis 104.
[0048] Four arm elements 108 are individually pivotably mounted
onto element 102 as by respective pins 110 for selectable pivotable
displacement into and partially out of respective radially and
axially extending slots 112 formed in element 102 and generally
symmetrically distributed about longitudinal axis 104.
[0049] Springs 114 are disposed in respective slots 112 and engage
respective arm elements 108 to urge the arm elements 108 radially
outwardly. Springs 114 are preferably mounted on respective pins
116 and are located in respective cut outs 118 formed in each of
arm elements 108. An axially driven collar engagement element 120
is removably mounted onto a forward end of driver assembly 106. A
rotation preventing pin 122 engages an axially extending slot 124
in driver assembly 106 to prevent rotation of collar engagement
element 120 relative to element 102 about axis 104.
[0050] As seen particularly in FIGS. 3A-3D, driver assembly 106
preferably comprises a generally cylindrical rod portion 130 in
which is axially extending slot 124 is formed. At a rear end of
generally cylindrical rod portion 130 there is preferably provided
a hand engagement portion 132, such as a disc. At a forward end of
generally cylindrical rod portion 130 there is preferably formed a
quick release connector portion 134 which is generally planar and
extends in a plane perpendicular to longitudinal axis 104 and has a
cut out 136 having an edge surface 138. Disposed partially within
and normally extending axially forward of connector portion 134
along axis 104 is a spring loaded ball engagement assembly 140,
such as a spring loaded ball assembly product GN-614.3-4-NI,
commercially available from ELESA-GANTER of 3 Triberger,
Furtwangen, Germany.
[0051] Reference is now additionally made to FIGS. 4A-4E, which
illustrate the hand-engageable element 102. The hand engageable
element 102 preferably comprises an integrally formed generally
circularly symmetric body, preferably formed of a molded or
machined rigid plastic or metal, such as DELRIN.RTM. or stainless
steel, including a generally cylindrical forward portion 150 having
a forward-facing generally circular edge 152. Rearward of forward
portion 150 there is preferably provided a forward generally
conical transition portion 154 having a rearwardly increasing outer
diameter.
[0052] Rearward of portion 154 there is preferably formed a main
cylindrical portion 156, followed by a rearward generally conical
transition portion 158 having an rearwardly increasing outer
diameter. Rearward of portion 158 there is preferably formed a
rearward cylindrical portion 160 having a rearward facing bulkhead
surface 162. Rearward of portion 160 there is preferably formed a
relatively narrow cylindrical portion 164 which terminates in a
winged generally planar end portion 166 having forward-facing wing
surfaces 168 and a rearward-facing surface 170.
[0053] Extending axially entirely through portions 166, 164, 160
and part of portion 158 of hand-engageable element 102 along
longitudinal axis 104 is a relatively narrow generally circular
cylindrical bore 180, which is sized to slidably accommodate and
guide generally cylindrical rod portion 130 in its axial
displacement relative to hand-engageable element 102.
[0054] Forwardly of cylindrical bore 180 there is formed in part of
portion 158 and in portions 156, 154 and 150 of hand-engageable
element 102 a relatively wide generally circular cylindrical bore
182 which defines the inner diameter of forward-facing generally
circular edge 152.
[0055] Axially extending slots 112 are seen to extend in mutually
adjacent 90 degree relative orientations forward from a location in
portion 164 slightly rearwardly of surface 162, forwardly through
portions 160, 158, 156, 154 and 150.
[0056] Bores 190 are formed in portion 160 to accommodate
respective pins 110. Bores 196 are formed in main cylindrical
portion 156 to accommodate respective pins 116 and bore 198 is
formed in portion 166 to accommodate pin 122, which extends partly
into bore 180 and thus engages axially extending slot 124 in driver
assembly 106.
[0057] Reference is now additionally made to FIGS. 5A-5C, which
illustrate the arm elements 108. As seen particularly in FIGS.
5A-5C, each arm element 108 is a generally planar element including
a rearward portion 200 of a first, relatively greater thickness and
a forward portion 202 of a second, relatively lesser thickness.
[0058] The rearward portion includes a rearwardly-disposed
transversely extending bore 204 which accommodates pin 110 and
cutout 118. Rearward portion includes an outer-facing edge surface
206 and a partially curved inward-facing edge surface 208.
[0059] Forward portion 202 includes a forwardmost finger portion
210 having a collar engagement edge surface 212 and a forward
disposed, inward-facing edge surface 214 which extends rearwardly
to a shoulder 216, rearward of which is a rearward disposed,
inward-facing edge surface 218. Extending rearwardly of collar
engagement edge surface 212 is partially curved outward-facing edge
surface 220.
[0060] Reference is now additionally made to FIGS. 6A-6F, which
illustrate axially driven collar engagement element 120. As seen in
FIGS. 6A-6F, the collar engagement element 120 is a generally
cylindrical symmetric element having a rearwardly-disposed hub 230
from which four collar engagement vanes 232, distributed about the
circumference of hub 230, extend axially forward.
[0061] Hub 230 defines a rearward-facing wall portion 234 having
formed therein an axial recess 236, which accommodates generally
cylindrical rod portion 130. Forwardly of rearward-facing wall
portion 234 there is provided a transverse slot 238, which
accommodates quick release connector portion 134 and separates
rearward-facing wall portion 234 from a rearward facing surface 240
of an intermediate wall portion 242, having formed therein a recess
244, arranged and configured to accommodate spring loaded ball
engagement assembly 140. When quick release connector portion 134
is inserted in transverse slot 238, edge surface 138 of cut out 136
is preferably aligned with or located radially interior of a
corresponding edge surface 246 of intermediate wall portion 242,
which is preferably at the same radial separation from axis 104 and
other corresponding edge surfaces 248 of intermediate wall portion
242 lying intermediate vanes 232.
[0062] Preferably a pad 250 formed of a resilient material is
attached to a forward facing surface 252 of intermediate wall
portion 242. Pad 250 typically engages a forward end of an
endoscope and is provided to protect that forward end against
impact damage.
[0063] Collar engagement vanes 232 preferably have a generally
rounded forward-facing edge surface 260 and a somewhat rounded
outer-facing collar engagement surface 262 as well as a somewhat
rounded inner-facing endoscope engagement surface 264.
[0064] In accordance with a preferred embodiment of the present
invention, vanes 232 have a length of approximately 16.5 mm and a
width of approximately 6.5 mm, and the thickness of pad 250 is
approximately 1.5 mm. According to a yet preferred embodiment of
the present invention, the distance between inner-facing endoscope
engagement surfaces 264 of opposing vanes 232 is approximately 14
mm, thereby allowing the insertion therebetween of endoscopes
having any diameter of up to approximately 13 mm without causing
damage to the endoscope.
[0065] It is appreciated that any suitable number of vanes 232 may
be employed. Accordingly, it is appreciated that any suitable
number of arm elements 108 may be employed. Specifically, three
vanes 232 and three arm elements 108 may be employed.
[0066] Reference is now made to FIGS. 7A, 7B, 7C, 7D, 7E, 7F, 7G,
7H, 7I, 7J, 7K, 7L, 7M, 7N, 7O, 7P and 7Q, which are simplified
illustrations of various stages in the operation of the device of
FIGS. 1 & 2 for mounting an auxiliary endoscope assembly onto
an endoscope, and of various stages in the operation of a collar
cutting tool for cutting a collar of an auxiliary endoscope
assembly mounted on an endoscope; and to FIGS. 8A, 8B, 8C, 8D, 8E,
8F, 8G, 8H, 8I, 8J, 8K, 8L, 8M, 8N, 8O and 8P, which are sectional
illustrations, taken along lines VIII-VIII in FIGS. 1 and 7A-7P in
corresponding FIGS. 7A-7P.
[0067] As seen in FIGS. 7A-8P, the device 100 is employed to mount
an auxiliary endoscope assembly 300 (shown in FIGS. 7A-8P) onto an
endoscope 302 (shown in FIGS. 7J-7L, 7O-7Q, and 8J-8P). Endoscope
302 is preferably a conventional endoscope, such as a VSB-3430K
video enteroscope or a EC-3470LK video colonoscope, which are
connectable to an endoscopy console 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.
[0068] In the illustrated example, the auxiliary endoscope assembly
is commercially available from Smart Medical Systems Ltd. of
Raanana, Israel under model designation NaviAid BGE and is
described in PCT Published Applications PCT/IL2005/000849,
PCT/IL2007/000600 and PCT/IL2007/000832, the disclosures of which
are hereby incorporated by reference. It is appreciated that device
100 may be employed alternatively to mount another type of assembly
having a resilient collar 304 onto an endoscope or other elongate
element. Resilient collar 304 has an axially outward facing
circumferential edge 306.
[0069] Preferably, collar 304 is formed of a resilient, relatively
stretchable material such as latex or stretchable silicone.
Preferably, the dimensions of collar 304 in a relaxed state are
length in the range of 6-20 mm, inner diameter in the range of 6-10
mm, and thickness in the range of 1-2 mm. In accordance with a
preferred embodiment of the present invention, collar 304 has a
length of approximately 10 mm, an inner diameter of approximately 8
mm, and an outer diameter of approximately 11 mm.
[0070] Preferably, collar 304 is configured for tight and fixed
mounting over endoscopes of various diameters. For example, a
collar 304 having a length of 10 mm, inner and outer diameters of 8
and 11 mm respectively in a relaxed state, and an inner diameter of
23 mm in the maximally stretched state, is suitable for tight and
fixed mounting on endoscopes having a diameter in the range of
9.8-13 mm.
[0071] FIGS. 7A and 8A show the device 100 and the auxiliary
endoscope assembly 300 prior to mutual engagement. Collar
engagement element 120 is engaged by quick release connector
portion 134. This engagement is maintained at least partially by
the engagement of spring loaded ball engagement assembly 140 with
recess 244.
[0072] FIGS. 7B and 8B show a user holding the device 100 in one
hand and holding the auxiliary endoscope assembly 300 in his other
hand, with the collar 304 facing the device 100. It is noted that
at this stage the driver assembly 106 is fully retracted with
respect to the hand-engageable element 102. It is also noted that
at this stage the user's hand engages outer-facing edge surfaces
206 and 220 of arm elements 108 and forces them, against the urging
of springs 114, radially inwardly to a maximum possible degree such
that collar engagement edge surfaces 212 of arm elements 108 define
a generally non-truncated cone and thus can enter collar 304 as
seen in FIGS. 7C and 8C and partially stretch the collar 304.
[0073] FIGS. 7D and 8D show collar engagement edge surfaces 212
partially stretching collar 304, when the user's hands no longer
force arm elements 108 inwardly. Normally springs 114 are selected
so that further stretching of collar 304 does not occur at this
stage, as can be seen from a comparison of FIGS. 8C and 8D, which
are identical.
[0074] FIGS. 7E and 8E show slight forward axial displacement of
the driver assembly 106 relative to hand-engageable element 102.
This forward displacement causes collar engagement element 120 to
move axially forward such that engagement between edge surface 246
and 248 of hub 230 of collar engagement element 120 and
corresponding inward-facing edge surfaces 208 forces arm elements
108 to pivot radially outwardly about pins 110 in bores 190 in
hand-engageable element 102, thus expanding the cone defined by
collar engagement edge surfaces 212 of finger portions 210 and
further stretching collar 304.
[0075] FIGS. 7F and 8F show additional forward axial displacement
of the driver assembly 106 relative to hand-engageable element 102.
This additional forward displacement causes collar engagement
element 120 to move axially forward to an additional extent such
that engagement between edge surface 246 and 248 of hub 230 of
collar engagement element 120 and corresponding inward-facing edge
surfaces 218 forces arm elements 108 to pivot radially further
outwardly about pins 110 in bores 190 in hand-engageable element
102, thus additionally expanding the cone defined by collar
engagement edge surfaces 212 of finger portions 210 and even
further stretching collar 304. This additional forward displacement
also causes forward portions of vanes 232 to be located inside
collar 304 but not in touching engagement therewith.
[0076] FIGS. 7G and 8G show further forward axial displacement of
the driver assembly 106 relative to hand-engageable element 102.
This further forward displacement causes collar engagement element
120 to move axially forward to a further extent such that
engagement between edge surfaces 246 and 248 of hub 230 of collar
engagement element 120 and corresponding inward-facing edge
surfaces 214, which are separated from inward-facing edge surfaces
218 by shoulders 216 and lie radially outward with respect to
surfaces 218, allows arm elements 108 to pivot radially inwardly
about pins 110 in bores 190 in hand-engageable element 102, under
the urging of the collar element 304 in engagement with collar
engagement edge surfaces 212. This contracts the truncated cone
defined by collar engagement edge surfaces 212 of finger portions
210 allowing collar 304 to be stretched only by virtue of the
touching and supporting engagement of outer-facing collar
engagement surfaces 262 of vanes 232 with the interior of collar
304.
[0077] FIGS. 7H and 8H show maximum forward axial displacement of
the driver assembly 106 relative to hand-engageable element 102.
This maximum forward displacement causes collar engagement element
120 to move axially forward to a maximum extent limited by the
engagement of pin 122 with a rearward end of slot 124 in generally
cylindrical rod portion 130 such that finger portions 210 of arm
elements 108 are no longer in touching engagement with the collar
304 and are retracted therefrom, thus allowing arm elements 108 to
pivot radially outward about pins 110 in bores 190 in
hand-engageable element 102, under the urging of springs 114.
[0078] FIGS. 7I and 8I show the collar 304 being stretched by
engagement with vanes 232 of collar engagement element 120 and
disengagement of the collar engagement element 120 from the
cylindrical rod portion 130.
[0079] FIGS. 7J and 8J show initial insertion of endoscope 302 into
a lumen 320 of the auxiliary endoscope assembly 300 from an end 322
of the auxiliary endoscope assembly 300 opposite that at which
collar 304 is located, while collar 304 is still being stretched by
engagement with vanes 232 of collar engagement element 120.
[0080] FIGS. 7K and 8K show full insertion of endoscope 302 into
lumen 320 of the auxiliary endoscope assembly 300 such that a
forward end 324 of endoscope 302 engages pad 250 on collar
engagement element 120.
[0081] FIGS. 7L and 8L show reengagement of the cylindrical rod
portion 130 with the collar engagement element 120, by insertion of
quick release connector portion 134 in slot 238 in collar
engagement element 120. This engagement is maintained at least
partially by the engagement of spring loaded ball engagement
assembly 140 with recess 244. At this stage the driver assembly 106
is preferably in its fully forward position.
[0082] Reference is now specifically made to FIGS. 7M, 7N, 8M and
8N which illustrate resilient outer tubular article disengagement
functionality operative for disengagement of at least a portion of
the resilient outer tubular collar 304 from the collar engagement
element 120.
[0083] FIGS. 7M and 8M show operation of initial retraction of the
driver assembly 106 relative to the hand-engageable element 102 to
a stage where forward-facing generally circular edge 152 touchingly
engages axially outward facing edge 306 of collar 304.
[0084] FIGS. 7N and 8N show full retraction of the driver assembly
106 relative to the hand-engageable element 102 to a stage where
the vanes 232 of collar engagement element 120 are retracted and
disengaged from the interior of the collar 304. At this stage the
resilient collar 304 tightly hugs the end 324 of the endoscope
302.
[0085] It is appreciated that the structure of device 100 and the
methodology described hereinabove normally will position the end
324 of the endoscope 302 at the predetermined distance from the
axially outward facing edge 306 of collar 304, which preferably
depends on the length of vanes 232. In accordance with a preferred
embodiment of the present invention, vanes 232 have a length of
approximately 16.5 mm and a width of approximately 6.5 mm, and the
thickness of pad 250 is approximately 1.5 mm, thereby providing
placement of a resilient collar 304 having a length of
approximately 10 mm in a distance of approximately 2-5 mm from the
forward edge of endoscope 302.
[0086] FIGS. 7O and 8O show an initial step in disengagement of the
auxiliary endoscope assembly 300 from endoscope 302. A collar
cutting tool 330 preferably having an elongate, tapered forward
finger 332 and a collar cutting edge 334 is employed for this
purpose. Forward finger 332 preferably demonstrates maximum
flexibility at a forward portion 336 thereof and gradually
increasing rigidity rearwardly thereof. Forward finger 332 is
preferably formed of a material whose hardness is lower than that
of an outer surface of endoscope 302, thereby to prevent possible
damage thereto. FIGS. 7O and 8O show insertion of forward portion
336 of the forward finger 332 between collar 304 and endoscope 302,
such that forward finger 332 functions as a spacer, spacing the
endoscope 302 from the collar 304 and the cutting edge 334.
[0087] FIGS. 7P and 8P show a further step in disengagement of the
auxiliary endoscope assembly 300 from endoscope 302. Collar cutting
edge 334 of collar cutting tool 330 engages outward facing edge 306
of collar 304, forming a cut 340 therein.
[0088] FIG. 7Q shows full slitting of collar 304 at cut 340, thus
eliminating the previous hugging engagement of collar 304 and
endoscope 302 (FIG. 7N). At this stage, the auxiliary endoscope
assembly 300 may be readily slid off the endoscope 302.
[0089] Reference is now made to FIG. 9, which is a simplified,
partially cut away, pictorial illustration of a double balloon
device 400, constructed and operative in accordance with a
preferred embodiment of the present invention, which is suitable
for mounting on a conventional endoscope. As seen in FIG. 9, the
double balloon device comprises a forward endoscope-mountable
inflatable balloon assembly 402 and a rearward endoscope-mountable
inflatable balloon assembly 404 which are interconnected by a
flexible forward balloon inflation/deflation tube 406.
[0090] Forward endoscope-mountable inflatable balloon assembly 402
preferably includes a generally flexible, preferably resilient
tubular sleeve 408, preferably having a forward-facing resilient
collar 410 integrally formed therewith. Collar 410 may be similar
to collar 304 described hereinabove and may alternatively be
separate from sleeve 408 and attached thereto as by an adhesive. It
is appreciated that collar 410 and sleeve 408, which are formed
separately, may be formed of different materials, or from similar
materials but with different properties such as strength,
flexibility, stretchability and dimensions. For example, sleeve 408
may be formed of a highly flexible and stretchable silicone
material, and collar 410 may be formed of a less flexible and less
stretchable silicone material having a higher expansion
resistance.
[0091] Sleeve 408 is preferably cylindrical and is arranged about
an axis 412 and preferably has a main lumen 414 for accommodating
an endoscope and a side lumen 416 for accommodating a forward
portion 418 of flexible forward balloon inflation/deflation tube
406. Side lumen 416 extends along part of the length of sleeve 408,
forwardly from its rearward facing end and outwardly of main lumen
414 along a generally spiral path with respect to axis 412 and
terminates in an open end 420. Preferably forward portion 418
extends partially along and inside side lumen 416 and is fixedly
and sealingly attached thereto as by a suitable adhesive, so as to
provide a sealed inflation/deflation pathway therewith. Typically
sleeve 408 has a length of approximately 8-15 cm.
[0092] It is appreciated that sleeve 408 may be constructed of a
flexible and stretchable material, such as flexible and stretchable
silicon, latex or rubber, thereby enabling it to conform to bending
of an endoscope onto which it is mounted. It is further appreciated
that main lumen 414 of sleeve 408 preferably has an untensioned
inner circumference slightly larger than the cross-sectional
circumference of an endoscope being inserted therethrough, thereby
allowing it to be pulled and slid over the endoscope during
mounting thereof.
[0093] A forward inflatable balloon 430 is sealably mounted onto an
outer surface of sleeve 408 and arranged with respect to side lumen
416 such that open end 420 of side lumen 416 lies interiorly
thereof for providing inflation and deflation thereof.
[0094] It is appreciated that in accordance with a preferred
embodiment of the present invention balloon 430 is generally
inflatable, and can be inflated to a diameter about 3-10 times
larger than its diameter when not inflated. In accordance with a
preferred embodiment of the present invention, useful for small
intestine endoscopy, the diameter of balloon 430 when fully
inflated is in the range of 35-45 mm. Preferably, inflation of
balloon 430 to a diameter less than 45 mm may be achieved using
relatively low pressure, such as in the range of 20-40
millibars.
[0095] In another specific embodiment, useful for large intestine
endoscopy, the diameter of balloon 430, when fully inflated, is in
the range of 4-6 centimeters. In a further embodiment, also useful
for large intestine endoscopy, the diameter of balloon 430, when
fully inflated, is six centimeters. Preferably, inflation of
balloon 430 to a diameter less than six centimeters may be achieved
using relatively low pressure, such as in the range of 20-40
millibars.
[0096] It is appreciated that in accordance with a preferred
embodiment of the present invention, useful for in vivo inspection
of a generally tubular body portion having a variable
cross-sectional diameter, the expansion diameter range of balloon
430, when mounted onto an endoscope, is larger than the maximum
cross-sectional diameter of the generally tubular body portion,
thereby enabling engagement of expanded balloon 430 with the
interior surface of the generally tubular body portion, and
anchoring of the endoscope thereto. Preferably, balloon 430 is a
relatively soft, highly compliant balloon, operative to at least
partially conform to the shape of the interior surface of the
generally tubular body portion when in engagement therewith.
[0097] It is appreciated that balloon 430 may be formed of suitable
well-known stretchable materials such as latex, flexible silicone,
or highly flexible nylon. Alternatively, balloon 430 may be formed
of polyurethane, which is less stretchable and conforming than
latex, flexible silicone or highly flexible nylon. Preferably, the
diameter of balloon 430 is sufficient to ensure tight anchoring at
any part of the generally tubular body portion. Alternatively,
balloon 430 may be obviated.
[0098] Rearward endoscope-mountable inflatable balloon assembly 404
preferably includes a generally non axially compressible, tubular
sleeve 438. Sleeve 438 is preferably cylindrical and in use is
arranged about axis 412 and preferably has a main lumen 440 for
accommodating an endoscope and first and second side lumens 442 and
444.
[0099] First side lumen 442 accommodates a rearward portion 446 of
flexible forward balloon inflation/deflation tube 406. First side
lumen 442 extends along the length of sleeve 438, outwardly of main
lumen 440 along a generally spiral path with respect to axis 412.
Preferably rearward portion 446 extends partially along and inside
a forward facing portion 448 of first side lumen 442 and is fixedly
and sealingly attached thereto as by a suitable adhesive, so as to
provide a sealed inflation/deflation pathway therewith. A forward
balloon inflation/deflation supply and exhaust tube 450 extends
from a connector 452 outside of assembly 404, partially along and
inside a rearward facing portion 454 of first side lumen 442 and is
fixedly and sealingly attached thereto as by a suitable adhesive,
so as to provide a sealed inflation/deflation pathway
therewith.
[0100] Second side lumen 444 accommodates a forward portion 462 of
a flexible rearward balloon inflation/deflation supply and exhaust
tube 464. Second side lumen 444 extends along part of the length of
sleeve 438, outwardly of main lumen 440 along a generally spiral
path with respect to axis 412 from a rear edge of sleeve 438 to an
open end 466. Rearward balloon inflation/deflation supply and
exhaust tube 464 extends from a connector 472 outside of assembly
404, partially along and inside a rearward facing portion 474 of
second side lumen 444 and is fixedly and sealingly attached thereto
as by a suitable adhesive, so as to provide a sealed
inflation/deflation pathway therewith.
[0101] A rearward inflatable balloon 480 is sealably mounted onto
an outer surface of sleeve 438 and arranged with respect to second
side lumen 444 such that open end 466 of second side lumen 444 lies
interiorly thereof for providing inflation and deflation thereof.
It is appreciated that in accordance with a preferred embodiment of
the present invention balloon 480 is generally inflatable, and can
be inflated to a diameter about 3-10 times larger than its diameter
when not inflated. In accordance with a preferred embodiment of the
present invention, useful for small intestine endoscopy, the
diameter of balloon 480 when fully inflated is in the range of
35-45 mm. Preferably, inflation of balloon 480 to a diameter less
than 45 mm may be achieved using relatively low pressure, such as
in the range of 20-40 millibars.
[0102] In another specific embodiment, useful for large intestine
endoscopy, the diameter of balloon 480, when fully inflated, is in
the range of 4-6 centimeters. In a further embodiment, also useful
for large intestine endoscopy, the diameter of balloon 480, when
fully inflated, is six centimeters. Preferably, inflation of
balloon 480 to a diameter less than six centimeters may be achieved
using relatively low pressure, such as in the range of 20-40
millibars.
[0103] It is appreciated that in accordance with a preferred
embodiment of the present invention, useful for in vivo inspection
of a generally tubular body portion having a variable
cross-sectional diameter, the expansion diameter range of balloon
480, when mounted onto sleeve 438, is larger than the maximum
cross-sectional diameter of the generally tubular body portion,
thereby enabling engagement of expanded balloon 480 with the
interior surface of the generally tubular body portion, and
anchoring of sleeve 438 thereto. Preferably, balloon 480 is a
relatively soft, highly compliant balloon, operative to at least
partially conform to the shape of the interior surface of the
generally tubular body portion when in engagement therewith.
[0104] It is appreciated that balloon 480 may be formed of suitable
well-known stretchable materials such as latex, flexible silicone,
or highly flexible nylon. Alternatively, balloon 480 may be formed
of polyurethane, which is less stretchable and conforming than
latex, flexible silicone or highly flexible nylon. Preferably, the
diameter of balloon 480 is sufficient to ensure tight anchoring at
any part of the generally tubular body portion. Alternatively,
balloon 480 may be obviated.
[0105] Preferably a fiducial mark 482 is provided at a rearward end
of sleeve 438 to enable an operator to monitor and prevent
undesired rotation of tube 438 about axis 412. Preferably, sleeve
438 is of a typical length of approximately 120-150 cm and has an
inner diameter of approximately 10-13.5 mm and an outer diameter of
approximately 12-15.5 mm, so as to be readily slidable over a
conventional endoscope. Preferably, sleeve 438 is configured for
mounting over endoscopes of various diameters, such as in the range
of 9.5-13 mm.
[0106] It is appreciated that sleeve 438 is relatively flexible,
thereby being able to conform to bending of the endoscope onto
which it is slidably mounted, and is yet sufficiently rigid so as
to allow its sliding over the endoscope by pushing it forward at a
rearward end thereof.
[0107] Sleeve 438 may be formed of any suitable material such as
silicone, PEBAX.RTM., PVC or polyurethane. In accordance with a
preferred embodiment of the present invention, the inner surface of
sleeve 438 is formed of a low-friction material, such as thin and
flexible internal TEFLON.RTM. tube or a hydrophilic coating, so as
to allow low resistance sliding of sleeve 438 over an endoscope in
a bent orientation.
[0108] Reference is now made to FIG. 10, which is a simplified
pictorial illustration of the double balloon device of FIG. 9,
mounted on a conventional endoscope 490 forming part of a
conventional endoscope system. Endoscope 490 may be identical to
endoscope 302 described hereinabove.
[0109] In practice, initially the rearward endoscope-mountable
inflatable balloon assembly 404 is slid over a forward end 492 of
endoscope 490 in the manner of a conventional overtube. Thereafter
the forward endoscope-mountable inflatable balloon assembly 402 is
fitted onto the endoscope with collar 410 being snugly mounted
adjacent the forward end 492 of endoscope 490 preferably by using
the device 100 described hereinabove with reference to FIGS. 1-7N
and 8A-8N.
[0110] Operation of the double balloon device 400 may be identical
or similar to that of a commercially available double-balloon
endoscope, such as a double balloon endoscope assembly including
EN-450T5 enteroscope, TS-13140 overtube and BS-2 front balloon,
which interface with balloon pump control BP-20 and 2200 video
system, all commercially available from Fujinon Inc., of 10 High
Point Drive, Wayne, N.J., USA.
[0111] Disengagement of the double balloon device 400 from
endoscope 490 following use, may be readily achieved by using the
collar cutting tool 330 described hereinabove with reference to
FIGS. 7O-7Q and 8O-8P.
[0112] Reference is now made to FIGS. 11A & 11B, which are
simplified pictorial illustrations of an endoscope overtube
constructed and operative in accordance with a preferred embodiment
of the present invention in respective open and closed
orientations; FIG. 12, which is a simplified exploded pictorial
illustration of the endoscope overtube of FIGS. 11A & 11B and
FIGS. 13A, 13B & 13C, which are respective simplified
pictorial, end view and side view illustrations of a balloon
employed in the endoscope overtube of FIGS. 11A-12.
[0113] As seen in FIGS. 11A-12, there is provided an endoscope
overtube 500 constructed and operative in accordance with a
preferred embodiment of the present invention including a generally
non axially compressible, tubular generally cylindrical sleeve 502
arranged about a longitudinal axis 504. Sleeve 502 is preferably
slit axially, as indicated by reference numeral 506, thus defining
axial slit edges 508 and 510 and thus is circumferentially
expandable and compressible. A selectably inflatable/deflatable
balloon 520 is mounted over part of an outer surface 522 of sleeve
502.
[0114] Sleeve 502 preferably has a main lumen 528 for accommodating
an endoscope 530, which may be similar to endoscope 302 described
hereinabove, and first and second side lumens 532 and 534 which are
circumferentially spaced from each other along outer surface 522 of
sleeve 502.
[0115] First side lumen 532 accommodates a forward portion 536 of a
flexible balloon inflation/deflation tube 540 and extends partially
along the length of sleeve 502, outwardly of main lumen 528, to an
opening 542 underlying and in fluid communication with the interior
of balloon 520. Preferably, flexible tube 540 extends from a
connector 544 outside of sleeve 502 and forward portion 536 thereof
extends partially along and inside a rearward-facing portion 546 of
first side lumen 532 and is fixedly and sealingly attached thereto
as by a suitable adhesive, so as to provide a sealed
inflation/deflation pathway therewith.
[0116] Second side lumen 534 accommodates a forward portion 548 of
a flexible instrument channel tube 550 which extends from a tool
insertion port 552 outside of sleeve 502. Second side lumen 534
extends along the entire length of sleeve 502, along outer surface
522 thereof and underlying balloon 520 from a rear edge of sleeve
502 to an open end 554. Instrument channel tube 550 extends from
port 552, partially along and inside a rearward facing portion 556
of second side lumen 534 and is fixedly attached thereto as by a
suitable adhesive.
[0117] Balloon 520 is preferably a preformed, flexible element,
having a generally cylindrical configuration when assembled onto
sleeve 502 and securely mounted onto endoscope 530 (FIG. 11B).
Balloon 520 includes peripheral sealing surfaces which are
preferably adhesively joined or heat welded onto outer surface 522
of sleeve 502. The peripheral sealing surfaces preferably include
respective forward and rearward circumferential collar sealing
surfaces 560 and 562 and first and second axial sealing surfaces
564 and 566 which extend parallel to slit edges 508 and 510.
[0118] It is appreciated that the generally axial slit 506 of
sleeve 502 may be straight or curved, such as a straight slit
parallel to longitudinal axis 504, a spiral slit along longitudinal
axis 504, or a sinusoidal slit. The forward edge of sleeve 502 is
preferably smooth and rounded so as to avoid damage to tissue under
examination during in vivo inspection of a generally tubular body
portion such as the intestine.
[0119] Preferably, sleeve 502 is of a typical length of
approximately 100-160 cm and has an inner diameter of approximately
10-13.5 mm and an outer diameter of approximately 12-15.5 mm, so as
to be readily slidable over a conventional endoscope. Preferably,
sleeve 502 is configured for mounting over endoscopes of various
diameters, such as in the range of 9.5-13 min. Yet preferably, the
thickness of sleeve 502 is in the range of 0.3-2 mm, and may be
constant or varying along its length.
[0120] In accordance with a preferred embodiment of the present
invention, the forward portion of sleeve 502 underlying balloon 520
is relatively rigid, thereby not allowing inward expansion of
sleeve 502 during inflation of balloon 520, so as to allow slidable
motion of endoscope 530 through sleeve 502 when balloon 520 is
inflated. Alternatively, the forward portion of sleeve 502
underlying balloon 520 is highly flexible, thereby allowing inward
expansion of sleeve 502 during inflation of balloon 520, so as to
engage endoscope 530 and fix its position relative to sleeve 502
when balloon 520 is inflated, thereby preventing slidable motion
therebetween.
[0121] It is appreciated that sleeve 502 is relatively flexible,
thereby being able to conform to bending of endoscope 530 onto
which it is slidably mounted, and is yet sufficiently rigid so as
to allow its sliding over endoscope 530 by pushing it forward at a
rearward end thereof. Sleeve 502 may be formed of any suitable
material such as silicone, PEBAX.RTM., PVC or polyurethane. In
accordance with a preferred embodiment of the present invention,
the inner surface of sleeve 502 is formed of a low-friction
material, such as thin and flexible internal TEFLON.RTM. tube or a
hydrophilic coating, so as to allow low resistance sliding of
sleeve 502 over an endoscope in a bent orientation.
[0122] It is appreciated that in accordance with a preferred
embodiment of the present invention balloon 520 is generally
inflatable, and can be inflated to a diameter about 3-10 times
larger than its diameter when not inflated. In accordance with a
preferred embodiment of the present invention, useful for small
intestine endoscopy, the diameter of balloon 520 when fully
inflated is in the range of 35-45 mm. Preferably, inflation of
balloon 520 to a diameter less than 45 mm may be achieved using
relatively low pressure, such as in the range of 20-40
millibars.
[0123] In another specific embodiment, useful for large intestine
endoscopy, the diameter of balloon 520, when fully inflated, is in
the range of 4-6 centimeters. In a further embodiment, also useful
for large intestine endoscopy, the diameter of balloon 520, when
fully inflated, is six centimeters. Preferably, inflation of
balloon 520 to a diameter less than six centimeters may be achieved
using relatively low pressure, such as in the range of 20-40
millibars.
[0124] It is appreciated that in accordance with a preferred
embodiment of the present invention, useful for in vivo inspection
of a generally tubular body portion having a variable
cross-sectional diameter, the expansion diameter range of balloon
520, when mounted onto sleeve 502, is larger than the maximum
cross-sectional diameter of the generally tubular body portion,
thereby enabling engagement of expanded balloon 520 with the
interior surface of the generally tubular body portion, and
anchoring of sleeve 502 thereto. Preferably, balloon 520 is a
relatively soft, highly compliant balloon, operative to at least
partially conform to the shape of the interior surface of the
generally tubular body portion when in engagement therewith.
[0125] It is appreciated that balloon 520 may be formed of suitable
well-known stretchable materials such as latex, flexible silicone,
or highly flexible nylon. Alternatively, balloon 520 may be formed
of polyurethane, which is less stretchable and conforming than
latex, flexible silicone or highly flexible nylon. Preferably, the
diameter of balloon 520 is sufficient to ensure tight anchoring at
any part of the generally tubular body portion. Alternatively,
balloon 520 may be obviated. A plurality of latches 570 are
provided for selectably securely mounting overtube 500 onto
endoscope 530 and are distributed along the length of overtube 500
other than underlying balloon 520. These latches preferably each
include an arm portion 572, which is joined at one end 574 thereof,
to outer surface 522 of sleeve 502 adjacent one of edges 508 and
510 of slit 506 as by adhesive or heat welding. At an opposite end
576 of each arm there is provided a first attachment portion 578
which removably engages a corresponding second attachment portion
580 mounted adjacent an opposite one of edges 508 and 510. In the
illustrated embodiment, the arm portions 572 are attached adjacent
edges 508 and the first attachment portion 578 is a recess which
mates with a corresponding protrusion defining the second
attachment portion 580. Any other suitable arrangement may be
employed.
[0126] Reference is now made to FIGS. 14A, 14B, 14C, 14D and 14E,
which are simplified illustrations of association of the endoscope
overtube of FIGS. 11A-12 with a conventional endoscope and a
conventional endoscope tool.
[0127] FIG. 14A shows the overtube 500 of FIGS. 11A-12 about to be
mounted on an endoscope 530 forming part of a conventional
endoscope system. The endoscope system may comprise, for example, a
conventional endoscope such as a VSB-3430K video enteroscope or a
EC-3470LK video colonoscope, which are connectable to an endoscopy
console 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. It is seen that a forward part of
overtube 500 is in an expanded open orientation such that slit 506
can accommodate the thickness of endoscope 530.
[0128] FIG. 14B shows a most forward part of overtube 500,
including part of balloon 520, latched in secure engagement with
endoscope 530. FIG. 14C shows more of overtube 500, including all
of balloon 520, latched in secure engagement with endoscope 530.
FIG. 14D shows all of overtube 500, latched in secure engagement
with endoscope 530. FIG. 14E illustrates the general configuration
of balloon 520 when inflated and the insertion of a conventional
endoscope tool through the instrument channel, defined by port 552,
tube 550 and second side lumen 534, which is preferably a low
friction lumen comprising a flexible internal TEFLON.RTM. tube, a
hydrophilic coating, or any alternative suitable low friction
lumen.
[0129] 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.
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