U.S. patent application number 17/569558 was filed with the patent office on 2022-04-28 for integrated endoscope cleansing system.
This patent application is currently assigned to Motus GI Medical Technologies Ltd.. The applicant listed for this patent is Motus GI Medical Technologies Ltd.. Invention is credited to Koby LULEKO, Mark POMERANZ, Boris SHTUL.
Application Number | 20220125289 17/569558 |
Document ID | / |
Family ID | |
Filed Date | 2022-04-28 |
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United States Patent
Application |
20220125289 |
Kind Code |
A1 |
SHTUL; Boris ; et
al. |
April 28, 2022 |
INTEGRATED ENDOSCOPE CLEANSING SYSTEM
Abstract
An integrated endoscope cleansing system (IECS) comprises both
an independent cleansing system (ICS) evacuation conduit in
communication with an independent cleansing system working station
(IWS), and an endoscope insertion tube with a working channel
functionally coupled to a vacuum source, under control of an
endoscope working station (EWS). In some embodiments, the ICS
evacuation conduit is located within the insertion tube, while
being functionally coupled to an ICS vacuum source, controlled by
the IWS.
Inventors: |
SHTUL; Boris;
(Kiryat-Motzkin, IL) ; LULEKO; Koby; (Eshchar,
IL) ; POMERANZ; Mark; (Millburn, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Motus GI Medical Technologies Ltd. |
Tirat HaCarmel |
|
IL |
|
|
Assignee: |
Motus GI Medical Technologies
Ltd.
Tirat HaCarmel
IL
|
Appl. No.: |
17/569558 |
Filed: |
January 6, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17267508 |
Feb 10, 2021 |
11246479 |
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PCT/IL2019/050919 |
Aug 16, 2019 |
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17569558 |
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62764779 |
Aug 16, 2018 |
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International
Class: |
A61B 1/12 20060101
A61B001/12; A61B 1/00 20060101 A61B001/00; A61B 1/005 20060101
A61B001/005; A61B 1/015 20060101 A61B001/015; A61B 1/018 20060101
A61B001/018; A61B 1/05 20060101 A61B001/05; A61B 1/31 20060101
A61B001/31 |
Claims
1. A method of operating an integrated endoscope cleaning system
(IECS) which includes: an endoscope cleaning system (ECS)
comprising a working channel, an independent cleansing system (ICS)
comprising an evacuation conduit, and at least one processor for
controlling activation of said ECS and said ICS, the method
comprising: introducing said ECS working channel and said ICS
evacuation conduit into the colon; controlling, via said at least
one processor, operation of said IECS, said controlling comprising
simultaneously evacuating matter through both said ECS working
channel and said ICS evacuation conduit when: (a) an indication of
a fall in pressure in one of said ECS working channel and said ICS
evacuation conduit is received, indicating a partial or complete
blockage; (b) an indication of a high volume of matter inside one
of said ECS working channel and said ICS evacuation conduit is
received, indicating that the volume of matter is too high for only
one of said ECS working channel and said ICS evacuation conduit to
evacuate alone.
2. The method according to claim 1, comprising simultaneously
evacuating matter through both the ECS working channel and the ICS
evacuation conduit when image information of the treated colon
indicates that supplemental cleansing of the colon is required.
3. The method according to claim 1, wherein said indication of a
fall in pressure is obtained by one or more sensors and wherein
said processor is configured to automatically activate evacuation
through the other of the ECS working channel and the ICS evacuation
conduit in response to said indication received from said one or
more sensors.
4. The method according to claim 1, wherein said controlling
comprises activating a vacuum source functionally coupled to said
ECS working channel or a vacuum source functionally coupled to said
ICS evacuation conduit to apply suction therethrough.
5. The method according to claim 1, wherein said controlling
comprises switching between using one of said ECS working channel
and said ICS evacuation conduit and using both of said ECS working
channel and said ICS evacuation conduit for evacuation of
matter.
6. The method according to claim 1, wherein said controlling
comprises activating one or more valves affecting the applying of
suction through each of said ECS working channel and said ICS
evacuation conduit.
7. The method according to claim 1, wherein said introducing
comprises introducing said ECS working channel and said ICS
evacuation conduit together through a bendable insertion tube of
the IECS.
8. The method according to claim 1, wherein said at least one
processor comprises at least two processors: an ECS processor and
an ICS processor configured to operate according to at least one
of: (a) ICS/ECS Master/Slave mode of operation; (b) ICS/ECS Smart
Master/Slave mode of operation; and (c) ECS/ICS Master/Slave mode
of operation.
9. The method according to claim 8, wherein each of said ECS
processor and said ICS processor is configured to activate
evacuation through said ECS working channel and said ICS evacuation
conduit respectively when needed.
10. The method according to claim 1, wherein said controlling
comprises modulating an evacuation pressure through one of said ECS
working channel and said ICS evacuation conduit while providing a
constant evacuation pressure through the other of said ECS working
channel and said ICS evacuation conduit.
11. An integrated endoscope cleaning system (IECS) comprising: an
endoscope cleaning system (ECS) comprising a working channel; an
independent cleansing system (ICS) comprising an evacuation
conduit; and at least one processor for controlling activation of
said ECS and said ICS, said at least one processor configured to
activate simultaneous evacuation of matter through both said ECS
working channel and said ICS evacuation conduit when: (a) an
indication of a fall in pressure in one of said ECS working channel
and said ICS evacuation conduit is received, indicating a partial
or complete blockage; (b) an indication of a high volume of matter
inside one of said ECS working channel and said ICS evacuation
conduit is received, indicating that the volume of matter is too
high for only one of said ECS working channel and said ICS
evacuation conduit to evacuate alone.
12. The system according to claim 11, further comprising at least
one ECS vacuum source and at least one ICS vacuum source.
13. The system according to claim 11, wherein the IECS comprises an
insertion tube and wherein said ECS working channel and said ICS
evacuation conduit are accommodated together within said insertion
tube.
14. The system according to claim 13, wherein said insertion tube
further accommodates at least one irrigation tube.
15. The system according to claim 11, comprising one or more
sensors in communication with said at least one processor, said one
or more sensors positioned and configured to measure at least one
of: pressure within a lumen of said ECS working channel and said
ICS evacuation conduit, flow of matter within a lumen of said ECS
working channel and said ICS evacuation conduit.
16. The system according to claim 15, wherein said one or more
sensors comprise at least one of a pressure sensor, a contact
sensor and a flowmeter.
17. The system according to claim 15, wherein at least one of said
one or more sensors is configured to indicate when a lumen of said
ECS working channel is blocked by a tool.
Description
RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 17/267,508, filed on Feb. 10, 2021, which is a
National Phase of PCT Patent Application No. PCT/IL2019/050919
having International Filing Date of Aug. 16, 2019, which claims the
benefit of priority under 35 USC .sctn. 119(e) of U.S. Provisional
Patent Application No. 62/764,779 filed on Aug. 16, 2018. The
contents of the above applications are all incorporated by
reference as if fully set forth herein in their entirety.
FIELD AND BACKGROUND OF THE INVENTION
[0002] The present invention, in some embodiments thereof, relates
to a body organ lumen cleaning system, and, more particularly, but
not exclusively, to an integrated endoscope body organ lumen
cleansing system (IECS).
[0003] While partially homogenizing food's original structure,
gastrointestinal processing also adds new structure; for example,
by aggregating digested particles, and by controlling stool water
content. As captured by the Bristol Stool Scale, for example, stool
is classified of a scale from 7 (completely liquid) to 1 (small
hard lumps). Variables affecting the state of fecal aggregation and
fluid content, as well as completeness of food digestion, include
the frequency of defecation (normally ranging from five times a day
to twice a week), and the speed at which food passes through the
gastrointestinal tract (10 hours to 4 days is normal). Gut flora
and secretions of the digestive tract also become part of the
stool.
[0004] A colonoscope provides means for optically and/or
electronically imaging the colon and its contents, for example, to
look for cancerous and/or pre-cancerous polyps. For effective
viewing, a common practice before colonoscopy is to clear as much
of a colon's contents as possible, sometimes by aggressive changes
to diet and/or by administration of purgatives. In some methods of
colon observation, imaging occurs while flushing or washing a
portion of the colon with an irrigating fluid. Irrigating fluid,
fecal matter and/or other colon contents are drawn out of the colon
by suction and/or other methods for transporting matter out of the
body. The following patent applications relate to the field of
endeavor of the current application: U.S. Patent Application
2010/0185056 by Tal Gordon et al.; U.S. Patent Application
2011/0105845 by Tal Gordon et al.; and U.S. Patent Application
2012/0101336 by Yoav Hirsch et al.
SUMMARY OF THE INVENTION
[0005] There is provided, in accordance with some embodiments of
the present disclosure, an integrated endoscope cleansing system
(IECS) comprising: an endoscope having: at least one insertion tube
in communication with an endoscope working station (EWS), and at
least one working channel functionally coupled to at least one
endoscope cleaning system (ECS) vacuum source, wherein the EWS is
configured to control the ECS vacuum source; and an independent
cleansing system (ICS) having: an independent cleansing system
working station (IWS), and having at least one ICS evacuation
conduit located within at least the insertion tube and functionally
coupled to an ICS vacuum source; wherein the IWS is configured to
control the ICS vacuum source.
[0006] In some embodiments, the evacuation conduit and the working
channel together comprise a single channel within the insert
tube.
[0007] In some embodiments, the evacuation conduit and the working
channel together comprise a single tube within the insert tube to
which both the ICS vacuum source and the ECS vacuum source are
functionally coupled.
[0008] In some embodiments, the IECS comprises at least one mode of
operation consisting of at least one of: (a) ICS/ECS Master/Slave
mode of operation; (b) ICS/ECS "Smart" Master/Slave mode of
operation; and (c) ECS/ICS Master/Slave mode of operation.
[0009] In some embodiments, the IECS comprises at least one mode of
operation toggle switch configured to toggle between at least two
of the modes of operation.
[0010] In some embodiments, the IECS is configured for manual
activation of at least one of the ECS and ICS.
[0011] In some embodiments, the IECS, in the manual mode of
operation, is configured to manually activate each of the ECS and
ICS individually, sequentially or concurrently.
[0012] In some embodiments, in the ICS/ECS Master/Slave mode of
operation, the ICS is activated and configured to automatically
activate the ECS.
[0013] In some embodiments, at least one of the IWS and EWS
comprises at least processor and at least one sensor configured to
communicate at least one operating parameter to the processor.
[0014] In some embodiments, the at least one operating parameter
comprises at least one of lumen pressure and flow of matter in a
lumen of at least one of the working channel and evacuation
conduit.
[0015] In some embodiments, in the ICS/ECS "Smart" Master/Slave
mode of operation, the IWS processor is configured to receive and
process the at least one operating parameter received from the EWS
processor and automatically activate the ECS based on the received
parameters.
[0016] In some embodiments, in the ECS/ICS Master/Slave mode of
operation, the EWS processor is configured to receive and process
the at least one operating parameter from the sensor and to
automatically activate the ICS based on the received parameter.
[0017] In some embodiments, the endoscope comprises a
colonoscope.
[0018] In some embodiments, the insertion tube is configured to
receive IECS components associated with at least one operating
function group.
[0019] In some embodiments, the at least one operating function
group comprises at least one of: (a) an endoscope operating
function group; (b) an ECS operating function group; and (c) an ICS
operating function group.
[0020] In some embodiments, the endoscope operating function group
comprises at least one of an endoscope angulation control
navigation cable, light wiring and circuitry, power circuitry,
image acquisition camera and circuitry and sensors and associated
circuitry.
[0021] In some embodiments, the ECS operating function group
comprises at least one suction/working channel and at least one
irrigation and/or air/water supply tube.
[0022] In some embodiments, the ICS operating function group
comprises at least one irrigation and/or air/water supply tube and
at least one evacuation conduit.
[0023] In some embodiments, the IECS comprises an interface.
[0024] In some embodiments, the interface is configured to couple
an umbilical cable originating from the IWS to the insertion
tube.
[0025] In some embodiments, the umbilical cable comprises at least
one irrigation tube and at least one evacuation conduit.
[0026] In some embodiments, the umbilical cable comprises sensor
circuitry.
[0027] In some embodiments, the umbilical cable is disposable.
[0028] In some embodiments, the insertion tube comprises at least
one bendable portion.
[0029] In some embodiments, the bendable portion comprises a
resilient, braided and/or ribbed wall.
[0030] In some embodiments, tubes housed within the bendable
portion are bendable in accordance with the bending of the bendable
portion.
[0031] In some embodiments, the insertion tube comprises a distal
tip having at least one opening.
[0032] In some embodiments, the at least one opening comprises at
least one fluid jet nozzle.
[0033] There is provided, in accordance with some embodiments of
the present disclosure, a method for a colonoscopy procedure,
comprising providing an integrated endoscope cleansing system
(IECS) comprising: an endoscope having: at least one mode of
operation toggle switch and at least one insertion tube in
communication with an endoscope working station (EWS), and at least
one working channel functionally coupled to at least one endoscope
cleaning system (ECS) vacuum source, wherein the EWS configured to
control the ECS vacuum source; and an independent cleansing system
(ICS) having: an independent cleansing system working station
(IWS), and at least one ICS evacuation conduit located within at
least the insertion tube and functionally coupled to an ICS vacuum
source, wherein the IWS configured to control the ICS vacuum
source; introducing the IECS insertion tube into a colon; and
performing the colonoscopy procedure; wherein performing the
colonoscopy procedure comprises adjusting the mode of operation
toggle switch between a first and a second mode of operation during
the colonoscopy procedure, and wherein the first and second modes
differ in configuration of a source of control of at least one of
the ICS and ECS vacuum sources.
[0034] In some embodiments, the first and second modes of
operations are selected from among the group consisting of: (a) a
manual mode of operation; (b) ICS/ECS Master/Slave mode of
operation; (c) ICS/ECS "Smart" Master/Slave mode of operation; and
(d) ECS/ICS Master/Slave mode of operation.
[0035] In some embodiments, in the manual mode of operation the
IECS is configured for manual activation of at least one of the ECS
and ICS.
[0036] In some embodiments, in the ICS/ECS Master/Slave mode of
operation the ICS is activated and configured to automatically
activate the ECS.
[0037] In some embodiments, at least one of the IWS and EWS
comprises at least processor and at least one sensor configured to
communicate at least one operating parameter to the processor.
[0038] In some embodiments, the at least one operating parameter
comprises at least one of lumen pressure and flow of matter in a
lumen of at least one of the working channel and evacuation
conduit.
[0039] In some embodiments, in the ICS/ECS "Smart" Master/Slave
mode of operation, the IWS processor is configured to receive and
process the at least one operating parameter received from the EWS
processor and automatically activate the ECS based on the received
parameters.
[0040] In some embodiments, in the ECS/ICS Master/Slave mode of
operation the EWS processor is configured to receive and process
the at least one operating parameter from the sensor and to
automatically activate the ICS based on the received parameter.
[0041] In some embodiments, adjusting the mode of operation toggle
switch comprises selecting the ICS/ECS Master/Slave mode of
operation.
[0042] In some embodiments, the method further comprises:
activating the ICS; advancing the IECS through the colon up to a
cecum while concurrently cleansing the colon with the ICS; and
automatically activating the ECS by the ICS when needed throughout
the advancement.
[0043] In some embodiments, the IECS comprises at least one image
acquisition camera and circuitry and the method further comprising:
upon reaching the cecum, adjusting the mode of operation toggle
switch and selecting ECS/ICS Master/Slave mode of operation;
activating image acquisition camera and circuitry; gradually
retracting the IECS from the cecum; activating the ECS when needed;
automatically activating ICS by ECS when needed; and removing the
IECS from colon.
[0044] Unless otherwise defined, all technical and/or scientific
terms used herein have the same meaning as commonly understood by
one of ordinary skill in the art to which the invention pertains.
Although methods and materials similar or equivalent to those
described herein can be used in the practice or testing of
embodiments of the invention, exemplary methods and/or materials
are described below. In case of conflict, the patent specification,
including definitions, will control. In addition, the materials,
methods, and examples are illustrative only and are not intended to
be necessarily limiting.
[0045] As will be appreciated by one skilled in the art, some
embodiments of the present invention may be embodied as a system,
method or computer program product. Accordingly, some embodiments
of the present invention may take the form of an entirely hardware
embodiment, an entirely software embodiment (including firmware,
resident software, micro-code, etc.) or an embodiment combining
software and hardware aspects that may all generally be referred to
herein as a "circuit," "module" or "system." Furthermore, some
embodiments of the present invention may take the form of a
computer program product embodied in one or more computer readable
medium(s) having computer readable program code embodied thereon.
Implementation of the method and/or system of some embodiments of
the invention can involve performing and/or completing selected
tasks manually, automatically, or a combination thereof. Moreover,
according to actual instrumentation and equipment of some
embodiments of the method and/or system of the invention, several
selected tasks could be implemented by hardware, by software or by
firmware and/or by a combination thereof, e.g., using an operating
system.
[0046] For example, hardware for performing selected tasks
according to some embodiments of the invention could be implemented
as a chip or a circuit. As software, selected tasks according to
some embodiments of the invention could be implemented as a
plurality of software instructions being executed by a computer
using any suitable operating system. In an exemplary embodiment of
the invention, one or more tasks according to some exemplary
embodiments of method and/or system as described herein are
performed by a data processor, such as a computing platform for
executing a plurality of instructions. Optionally, the data
processor includes a volatile memory for storing instructions
and/or data and/or a non-volatile storage, for example, a magnetic
hard-disk and/or removable media, for storing instructions and/or
data. Optionally, a network connection is provided as well. A
display and/or a user input device such as a keyboard or mouse are
optionally provided as well.
[0047] Any combination of one or more computer readable medium(s)
may be utilized for some embodiments of the invention. The computer
readable medium may be a computer readable signal medium or a
computer readable storage medium. A computer readable storage
medium may be, for example, but not limited to, an electronic,
magnetic, optical, electromagnetic, infrared, or semiconductor
system, apparatus, or device, or any suitable combination of the
foregoing. More specific examples (a non-exhaustive list) of the
computer readable storage medium would include the following: an
electrical connection having one or more wires, a portable computer
diskette, a hard disk, a random access memory (RAM), a read-only
memory (ROM), an erasable programmable read-only memory (EPROM or
Flash memory), an optical fiber, a portable compact disc read-only
memory (CD-ROM), an optical storage device, a magnetic storage
device, or any suitable combination of the foregoing. In the
context of this document, a computer readable storage medium may be
any tangible medium that can contain, or store a program for use by
or in connection with an instruction execution system, apparatus,
or device.
[0048] A computer readable signal medium may include a propagated
data signal with computer readable program code embodied therein,
for example, in baseband or as part of a carrier wave. Such a
propagated signal may take any of a variety of forms, including,
but not limited to, electro-magnetic, optical, or any suitable
combination thereof. A computer readable signal medium may be any
computer readable medium that is not a computer readable storage
medium and that can communicate, propagate, or transport a program
for use by or in connection with an instruction execution system,
apparatus, or device.
[0049] Program code embodied on a computer readable medium and/or
data used thereby may be transmitted using any appropriate medium,
including but not limited to wireless, wireline, optical fiber
cable, RF, etc., or any suitable combination of the foregoing.
[0050] Computer program code for carrying out operations for some
embodiments of the present invention may be written in any
combination of one or more programming languages, including an
object oriented programming language such as Java, Smalltalk, C++
or the like and conventional procedural programming languages, such
as the "C" programming language or similar programming languages.
The program code may execute entirely on the user's computer,
partly on the user's computer, as a stand-alone software package,
partly on the user's computer and partly on a remote computer or
entirely on the remote computer or server. In the latter scenario,
the remote computer may be connected to the user's computer through
any type of network, including a local area network (LAN) or a wide
area network (WAN), or the connection may be made to an external
computer (for example, through the Internet using an Internet
Service Provider).
[0051] Some embodiments of the present invention may be described
below with reference to flowchart illustrations and/or block
diagrams of methods, apparatus (systems) and computer program
products according to embodiments of the invention. It will be
understood that each block of the flowchart illustrations and/or
block diagrams, and combinations of blocks in the flowchart
illustrations and/or block diagrams, can be implemented by computer
program instructions. These computer program instructions may be
provided to a processor of a general purpose computer, special
purpose computer, or other programmable data processing apparatus
to produce a machine, such that the instructions, which execute via
the processor of the computer or other programmable data processing
apparatus, create means for implementing the functions/acts
specified in the flowchart and/or block diagram block or
blocks.
[0052] These computer program instructions may also be stored in a
computer readable medium that can direct a computer, other
programmable data processing apparatus, or other devices to
function in a particular manner, such that the instructions stored
in the computer readable medium produce an article of manufacture
including instructions which implement the function/act specified
in the flowchart and/or block diagram block or blocks.
[0053] The computer program instructions may also be loaded onto a
computer, other programmable data processing apparatus, or other
devices to cause a series of operational steps to be performed on
the computer, other programmable apparatus or other devices to
produce a computer implemented process such that the instructions
which execute on the computer or other programmable apparatus
provide processes for implementing the functions/acts specified in
the flowchart and/or block diagram block or blocks.
[0054] Some of the methods described herein are generally designed
only for use by a computer, and may not be feasible or practical
for performing purely manually, by a human expert. A human expert
who wanted to manually perform similar tasks, such as monitor fluid
input and output, waste matter suction and similar, might be
expected to use completely different methods, e.g., making use of
expert knowledge and/or the pattern recognition capabilities of the
human brain, which would be vastly more efficient than manually
going through the steps of the methods described herein.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0055] Some embodiments of the invention are herein described, by
way of example only, with reference to the accompanying drawings.
With specific reference now to the drawings in detail, it is
stressed that the particulars shown are by way of example and for
purposes of illustrative discussion of embodiments of the
invention. In this regard, the description taken with the drawings
makes apparent to those skilled in the art how embodiments of the
invention may be practiced.
[0056] In the drawings:
[0057] FIG. 1 is a plan view and simplified block diagram
illustration of an integrated endoscope and cleaning system (IECS)
in accordance with some embodiments of the invention;
[0058] FIGS. 2A-2B are a simplified block diagrams of a mode of
operation of IECS in accordance with some embodiments of the
invention;
[0059] FIGS. 3A, 3B and 3C are simplified block diagrams of a mode
of operation of IECS in accordance with some embodiments of the
invention;
[0060] FIGS. 4A, 4B and 4C are simplified block diagrams of a mode
of operation of IECS in accordance with some embodiments of the
invention;
[0061] FIGS. 5A, 5B and 5C are simplified block diagrams of a mode
of operation of IECS in accordance with some embodiments of the
invention;
[0062] FIG. 6 is a simplified block diagram of an IECS mode of
operation toggle switch in accordance with some embodiments of the
invention;
[0063] FIGS. 7A and 7B are a simplified flow chart of
implementation of IECS in a colonoscopy procedure in accordance
with some embodiments of the invention;
[0064] FIGS. 8A and 8B are part block diagram, cross-section view,
simplified illustrations of an IECS interface in accordance with
some embodiments of the invention;
[0065] FIG. 9 is a cross-section view simplified illustration of
IECS insertion tube in accordance with some embodiments of the
invention;
[0066] FIG. 10 is a perspective view simplified illustration of an
IECS endoscope insertion tube bendable portion in accordance with
some embodiments of the invention; and
[0067] FIG. 11 is a perspective view simplified illustration of an
IECS distal tip in accordance with some embodiments of the current
invention.
DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION
[0068] The present invention, in some embodiments thereof, relates
to a body organ lumen cleaning system, and, more particularly, but
not exclusively, to an integrated endoscope body organ lumen
cleaning system (IECS).
[0069] As used herein, the term "Proximal" means close to a user
and/or away from the body being treated. The term "Distal" means
away from the user and/or close to the body being treated.
[0070] An aspect of some embodiments of the invention relates to an
integrated endoscope cleaning system (IECS). In some embodiments,
the IECS is configured to operate in one or more modes of
operation. In some embodiments, The IECS comprises one or more
modes of operation toggle switches configured to toggle the IECS
between one or more modes of operations.
[0071] Herein, the term "toggle switch" is used (particularly in
the phrasing "mode of operation toggle switch") to refer to any
switching mechanism, (e.g., mechanical and/or electronic, operating
by means of software and/or hardware, and optionally comprising one
or a plurality of separately switched selections) which allows
selecting from among two, three, four, five, or more modes of
operation. For example, in some embodiments, a single switch
toggles between two or more modes of operation; in some
embodiments, two or more switches are functionally combined as a
toggle switch configured to select from among two or more modes of
operation.
[0072] In some embodiments, the IECS comprises one or more lumen
cleaning systems. In some embodiments, the IECS comprises an
endoscope cleaning system (ECS). In some embodiments, the IECS
comprises an independent cleaning system (ICS). In some
embodiments, the IECS comprises at least one an endoscope cleaning
system (ECS) and at least one independent cleaning system (ICS). In
some embodiments, the endoscope cleaning system (ECS) and the
independent cleaning system (ICS) are housed together at least
within an endoscope insertion tube.
[0073] In some embodiments, one or more modes of operation comprise
a manual mode of operation. In some embodiments, in the manual mode
of operation the IECS is configured for manual activation to enable
a user to activate at least one of the endoscope cleaning system
(ECS) and the independent cleaning system (ICS). In some
embodiments, the manual mode of operation the IECS is configured to
activate both the endoscope cleaning system (ECS) and the
independent cleaning system (ICS) concurrently.
[0074] In some embodiments, one or more modes of operation comprise
an ICS/ECS Master/Slave mode of operation. In some embodiments, the
ICS/ECS Master/Slave mode of operation the IECS is configured to
activate the independent cleaning system (ICS). In some
embodiments, the independent cleaning system (ICS) is configured to
automatically activate the endoscope cleaning system (ECS) as
needed.
[0075] In some embodiments, at least one of the ICS and ECS
comprises one or more corresponding Independent system Working
Station (IWS) and Endoscope Working Station (EWS). In some
embodiments, at least one of the IWS and EWS comprises at least one
processor configured to at least one of process imager signals,
process sensor signals, control one or more of the pumps and/or
valves, and communicate processed information to a monitor.
[0076] In some embodiments, one or more modes of operation comprise
an ICS/ECS "Smart" Master/Slave mode of operation. In some
embodiments, in the ICS/ECS "Smart" Master/Slave mode of operation
the IECS is configured to activate the endoscope cleaning system
(ECS). In some embodiments, an independent cleaning system (ICS)
processor is configured to receive and process operating parameters
received from an Endoscope Working Station (EWS) processor and
automatically activate the ICS based on the received
parameters.
[0077] In some embodiments, one or more modes of operation
comprises ECS/ICS Master/Slave mode of operation. In some
embodiments, the ECS/ICS Master/Slave mode of operation the IECS is
configured to activate the endoscope cleaning system (ECS). In some
embodiments, the endoscope cleaning system (ECS) EWS processor is
configured to receive and process operating parameters and to
automatically activate the ICS as needed based on the received
parameters.
[0078] An aspect of some embodiments of the invention relates to an
IECS. In some embodiments the interface couples an umbilical cable
originating from the IWS to the IECS insertion tube. In some
embodiments, the umbilical cable accommodates at least one ICS
evacuation conduit. In some embodiments, the umbilical cable
accommodates at least one ICS irrigation tube. In some embodiments,
the umbilical cable accommodates at least one sensor circuitry in
communication with the IWS processor. In some embodiments, the
umbilical cable is disposable.
[0079] Optionally, in some embodiments the interface comprises a
flexible joint configured to allow flexion and extension of a
branch of the interface. In some embodiments, the interface
comprises conduits that communicate with corresponding conduits
permanently accommodated within the insertion tube.
[0080] An aspect of some embodiments of the invention relates to an
endoscope insertion tube bendable portion. In some embodiments, the
bendable portion is configured to be driven by one or more
endoscope navigation cables. In some embodiments, the bendable
portion is configured to bend radially at least up to 180 degrees
in vertical (up and down) directions and at least up to 160 degrees
in horizontal (left and right) directions.
[0081] An aspect of some embodiments of the invention relates to an
IECS insertion tube distal tip comprises one or more openings. In
some embodiments, a first end of one or more conduits opens to one
or more openings at the tip of the insertion tube. In some
embodiments, a second end of the one or more conduits opens to one
or more ports in the tube. In some embodiments, the ports are
located between the colonoscope handle end and the one or more
openings at the tip of the insertion tube. In some embodiments, the
one or more of the conduits are permanently accommodated within the
tube. In some embodiments, the one or more openings comprise fluid
jet nozzles that eject fluid jets. In some embodiments, one or more
fluid/air apertures are angled to aim fluid/air at a lens of a
camera received inside the distal tip.
[0082] Reference is now made to FIG. 1, which is a plan view and
simplified block diagram illustration of an integrated endoscope
and cleaning system (IECS) in accordance with some embodiments of
the invention. As shown in the exemplary embodiment depicted in
FIG. 1, an IECS 100 comprises an endoscope 101 having an endoscope
handle 102, an interface portion 116 and endoscope insertion tube
118 including a distal end tip 130 and a bendable portion 132. In
some embodiments, endoscope 101 comprises a colonoscope. In some
embodiments, IECS 100 comprises one or more lumen cleaning systems:
an endoscope cleaning system (ECS) 150 and an independent cleaning
system (ICS) 155.
[0083] In some embodiments, ECS 150 comprises an endoscope handle
102 in fluid and data communication with an Endoscope Working
Station (EWS) 106 via at least one umbilical cable 104 carrying at
least one or more air and/or water supply tubes in fluid
communication with respective EWS 106 air 108 and/or water 110
sources communicating with respective air 178 and/or water 170
supply tubes and one or more suction tubes in fluid communication
with an EWS source of vacuum 112. In some embodiments, EWS 106
comprises a waste reservoir 111. In some embodiments, EWS 106
comprises a processor 114 having a database. In some embodiments,
handle 102 is in data communication with an EWS 106 processor 114.
Additionally and optionally, EWS 106 processor 124 is configured to
receive data from and control one or more fluid pumps, light and
power sources (not shown).
[0084] In some embodiments, integrated endoscope and cleaning
system (IECS) 100 independent cleaning system (ICS) includes at
least one ICS Working Station (IWS) 126 in fluid and data
communication with endoscope insertion tube body 118 via at least
one umbilical cable 136 carrying at least one or more air and/or
water supply tubes (not shown) in fluid communication with
respective IWS 126 air 128 and/or water 120 sources via one or more
control valves 144 and one or more suction tubes in fluid
communication with an CSWS source of vacuum 122 and controlled by
one or more valves 146. Additionally and optionally, IWS 126
comprises at least one evacuation reservoir 121 and at least one
processor 124 having a database and receiving data from and
controlling one or more fluid pumps, light, image acquisition and
power sources (not shown). In some embodiments, IWS 126 processor
124 is in data communication with handle 102 as indicated in FIG. 1
by an arrow designated reference numeral 145.
[0085] In some embodiments and optionally, ICS 155 comprises one or
more fluid jet nozzles (not shown) configured eject fluid jets to
agitate and break up matter in an examined lumen e.g., fecal matter
in the colon. In some embodiments the jet nozzles eject directional
fluid jets directed by IWS 126. In some embodiments, the jet
nozzles are located adjacent a camera head and are directed to
clean a camera lens from debris.
[0086] In some embodiments, endoscope handle 102 comprises at least
one suction control valve 138 and at least one air/water control
valve 140. In some embodiments, suction control valve 138 and
air/water control valve 140 are configured to be activated manually
by a user. Alternatively and optionally, in some embodiments,
suction control valve 138 and air/water control valve 140 are in
data communication with IWS 126 processor 114. Optionally, in some
embodiments, suction control valve 138 and air/water control valve
140 are controlled by at least one of manually and IWS 126
processor 114. In some embodiments and as explained in greater
detail elsewhere herein, endoscope handle 102 comprises at least
one IECS mode of operation toggle switch 142. In some embodiments,
mode of operation toggle switch 142 is configured to select between
one or more modes of operation of IECS 100.
[0087] In some embodiments and as explained in greater detail in
relation to embodiments elsewhere herein (for example, in relation
to FIGS. 2A-2B, 3A, 4A, 5A, and/or 9) endoscope insertion tube 118
comprises at least one working channel 134 optionally functionally
coupled to at least one EWS 106 vacuum source 112 as indicated by
broken line arrow 147 and at least one fluid supply tube 148
comprising at least one of air 178 and/or water 170 supply tube in
fluid communication with at least one of EWS 106 air 108 and/or
water 110 sources. In some embodiments, endoscope insertion tube
118 comprises at least one evacuation tube 152 functionally coupled
to at least one IWS 126 vacuum source 122 and/or at least one fluid
supply tube 154 comprising at least one of air and or water supply
tubes in fluid communication with at least one of IWS 126 air 128
and/or water 120 sources.
[0088] For purposes of presentation, tube/channel/conduit elements
are presented as separate elements in some examples, and in
particular are described as being separately assigned to EWS 106
and IWS 126 (e.g., via function groups 204 and 206). However, it
should be understood that these elements are optionally shared by
being in a fluid interconnection, with control by the EWS 106, IWS
126, or a combination thereof. Control is conferred, shared, and/or
transferred, e.g., by the use of control valves 138, 140, 144, 146.
In some embodiments, evacuation tube 152 joins to (and optionally
comprises) working channel 134, with working channel 134 being
joined (e.g., by means of a Y-tube connection) to both the EWS 106
(e.g., via control valve 138) and to the IWS 126 (e.g., via control
valve 146). Additionally or alternatively, evacuation tube 152 and
working channel 134 together comprise a single channel within the
insertion tube, for example as a single tube shared between EWS 106
and IWS 126, or as a plurality of tubes shared between EWS 106 and
IWS 126. Some potential advantages of this stem from joint and/or
or alternative application of suction to the same channel. For
example, in some embodiments, IWS 126 directly provides a high
throughput alternative and/or additional mode of operation to the
same working channel used for evacuation by EWS 106 (e.g., by
application of a higher level of suction). In some embodiments, one
of EWS 106 and IWS 126 provides capability for modulation of
evacuation pressure, while the other provides a constant or merely
on/off source of evacuation pressure. Optionally, the modulation is
sensor-driven. For example, upon the sensed occurrence of blockage
and/or the beginning of obstruction, one of EWS 106 and IWS 126
operates to clear the block by reversing pressure, while vacuum
pressure from the other is optionally switched off, or
alternatively left on but modulated by pressure changes driven by
the other. Sharing a tube allows the blockage clearance and/or
other sensor driven capabilities of one station to assist the
evacuation capabilities (perhaps more basic) of the other station.
In some embodiments, there are a limited number of conduits
available, and it is preferred to concentrate evacuation to, e.g.,
just one of them, so that another is available as a working channel
for a tools. Potentially, one of EWS 106 and IWS 126 is more
aggressive in applying suction, and it is preferred to have this
aggressive suction active only at selected times--for example,
during cleaning under the active guidance of an operator. This
potentially increases safety of the device at other times, improves
handling, makes control of insufflation level easier, and/or
reduces pump noise or other evacuation-related side effects. In
some embodiments, the device is configured to switch between using
one tube for evacuation and two (that is, switch between using a
lesser and greater number of tubes), allowing reconfiguration of
evacuation capacity (e.g., in the midst of a procedure) to suit the
changing demands of different phases of the procedure.
[0089] Additionally or alternatively, in some embodiments, fluid
supply tube 154 joins to (and optionally comprises) fluid supply
tube 148, with fluid supply tube 148 being joined (e.g., by means
of a Y-tube connection) to both the EWS 106 (e.g., via control
valve 140) and the IWS 126 (e.g., via control valve 144).
Additionally or alternatively, fluid supply tube 154 and fluid
supply tube 148 together comprise a single channel within the
insertion tube; for example as a single tube shared between EWS 106
and IWS 126, or as a plurality of tubes shared between EWS 106 and
IWS 126. As for evacuation, sharing a single tube potentially frees
up another tube for other uses in some embodiments. As for
evacuation, sharing one or more tubes potentially allows
cross-provision of capabilities. For example, IWS 126 may be
configured to supply a different fluid or mix of fluids (e.g., an
air/liquid mix for producing jets) than EWS 106. In some
embodiments, the device is configured to switch between using one
tube for fluid supply and two (that is, switch between using a
lesser and greater number of tubes), allowing reconfiguration of
irrigation capacity (e.g., in the midst of a procedure) to suit the
changing demands of different phases of the procedure.
IECS Modes of Operation
[0090] As will be explained in greater detail herein IECS 100 is
configured to operate in one or more optional modes of operation
including at least:
[0091] a) Manual mode of operation
[0092] b) ICS/ECS Master/Slave mode of operation
[0093] c) ICS/ECS "Smart" Master/Slave mode of operation
[0094] d) ECS/ICS Master/Slave mode of operation
Manual Mode of Operation
[0095] Reference is now made to FIG. 2A-2B, which are a simplified
block diagrams of a mode of operation of IECS 100 in accordance
with some embodiments of the invention. As shown in the exemplary
embodiments depicted in FIG. 2A-2B and disclosed elsewhere herein,
IECS 100 comprises at least three function groups:
[0096] a) An endoscope operating function group 202 controlled by
an operator 250 and optionally by EWS 106 and comprising at least
one or more endoscope angulation controls and navigation cables,
light wiring and circuitry, power circuitry, image acquisition
camera and circuitry and sensors and associated circuitry;
[0097] b) An ECS 150 function group 204 controlled by EWS 106 and
comprising one or more suction/working channels 134 and one or more
irrigation and/or air 178/water 170 supply tubes coupled to air 108
and/or water 110 sources via one or more valves 140. In some
embodiments, one or more suction/working channels 134 are
functionally coupled to vacuum source 112 via one or more suction
control valves 138. In some embodiments, suction/working channels
134 and one or more irrigation and/or air 178/water 170 supply
tubes are one or more irrigation and/or air/water supply tubes
disposed at least in part through endoscope 101 insertion tube 118.
Additionally and optionally, ECS 150 function group 204 comprises
sensors and their associated circuitry in communication with EWS
106 processor 114.
[0098] c) An ICS 155 function group 206 controlled by IWS 126 and
comprising one or more irrigation and/or air/water supply tubes
coupled to air 128 and/or water 120 sources via one or more valves
144 and one or more evacuation conduits 152 in fluid communication
with vacuum source 122 via one or more vacuum control valves 146.
In some embodiments, one or more evacuation conduits 152 and/or one
or more air/water supply tubes 154 are disposed at least in part
through endoscope 101 insertion tube 118. Additionally and
optionally, ICS 155 function group 206 comprises sensors and their
associated circuitry in communication with IWS 126 processor
124.
[0099] In the exemplary configuration depicted in FIGS. 2A-2B, an
operator 250 toggles manually between operation of ECS 150 alone,
ICS 155 alone or joint manual activation of ECS 150 and ICS 155. In
some embodiments, ICS 155 comprises fluid jet nozzles (not shown)
configured to agitate and break up matter in the examined lumen
e.g., fecal matter in the colon. The manual mode of operation
provides for local imaging and cleaning of a portion of a colon
employing ECS 150 when needed and activation of ICS 155 under
conditions in which the ability of ECS cleaning operation is
insufficient and requires supplementary cleaning and/or agitation
and break up of matter in the examined lumen. In some embodiments,
one or more directional jet nozzles are located on a camera head
and directed by IWS 126.
[0100] In some embodiments, ECS function group 204 and/or ICS
function group 206 enter endoscope 101 via interface portion 116
and are accommodated within endoscope 101 insertion tube 118 (FIG.
1). In some embodiments, ECS 150 group 204 and optionally endoscope
operating group 202 are controlled and supplied from air 108/water
110 and or vacuum 112 sources by EWS 106. In some embodiments, ICS
155 group 206 is independently controlled and supplied from air
128/water 120 and or vacuum 122 sources in IWS 126.
[0101] In some embodiments and as shown in FIGS. 2A-2B, IECS 100
comprises one or more mode of operation toggle switches 142. In
some embodiments, mode of operation toggle switch 142 is configured
to be adjusted manually by an operator 250 or, alternatively and
optionally, by an IECS 100 computer (not shown) and set at a
desired mode of operation. In some embodiments, mode of operation
toggle switch 142 is optionally set to operate ECS 150. EWS 106 is
configured to activate and operate at least air 108/water 110
and/or vacuum 112 sources as well as air/water control valve 140
and suction control valve 138 respectively corresponding to the
setting of mode of operation toggle switch 142.
[0102] In the exemplary configuration shown in FIGS. 2A-2B, air
and/or water flow through endoscope supply and/or irrigation tubes
140 disposed in ECS 150 group 204 and vacuum source 112 supplies
endoscope working channel 134 with suction. EWS 150 controls one or
more suction control valves 138 and one or more air/water supply
valves 140.
[0103] In some embodiments, mode of operation toggle switch 142 is
optionally set to operate ICS 155. IWS 126 is configured to
activate and operate at least air 128/water 120 and/or vacuum 122
sources as well as air/water control valve 144 and suction control
valve 146 respectively corresponding to the setting mode of
operation toggle switch 142.
[0104] In the exemplary configuration shown in FIGS. 2A-2B, air
and/or water flow through endoscope supply and/or irrigation tubes
154 disposed in ICS 155 group 206 and vacuum source 122 supplies
evacuation conduit 152 with suction. CSWS 155 controls one or more
suction control valves 146 and one or more air/water supply valves
144.
[0105] Distinguishing between FIGS. 2A and 2B, function groups 206
and 204 are shown merged to a single group of tubes. In some
embodiments, irrigation tubes 154 and 148 are merged (e.g., at
Y-connector 171) and continue as a single tube through insertion
tube 118. In some embodiments (additionally or alternatively)
evacuation conduit 152 and working channel 134 are merged (e.g., at
Y-connector 172) and continue as a single tube through insertion
tube 118.
[0106] In some embodiments, the merging is four-way; e.g.
irrigation tubes 154 and 148 are merged at a four-way connector to
connect to both of control valves 140, 144, and/or evacuation
conduit 152 and working channel 134 are merged at a four-way
connector to connect to both of control valves 138, 146.
[0107] Although drawn separately in other embodiments herein for
purposes of presentation, it should be understood that in
alternative embodiments of any of these, function group 206 and
function group 204 share one or more tubes (e.g., by 3-way and/or
4-way connections) for example as just described in relation to
FIG. 2B, and/or as described in relation to FIG. 9 and/or FIG. 1,
herein.
ICS/ECS Master/Slave Mode of Operation
[0108] Reference is now made to FIGS. 3A, 3B and 3C, collectively
referred to as FIG. 3, which are simplified block diagrams of a
mode of operation of IECS 100 in accordance with some embodiments
of the invention. As shown in the exemplary embodiment depicted in
FIGS. 3A-3C, in some embodiments, mode of operation toggle switch
142 is optionally set to operate ICS 155 and ECS 150 in a
respectively Master/Slave mode of operation.
[0109] In the exemplary configuration depicted in FIGS. 3A-3C, ICS
155 is configured to control IWS 155 valves 144/146 as well as EWS
150 valves 138/140 as indicated by an arrow 350. In this
configuration ICS 155 is configured to operate independently and
automatically activate ECS 150 when needed. For example, in a
colonoscopy procedure IECS 100 is introduced into the colon and
advanced along the colon up to the cecum. In some embodiments, ICS
155 is activated e.g., to cleanse the colon in preparation for an
imaging portion of the procedure. The cleansing process is carried
out concurrently with the advancement of IECS 100 in the colon.
[0110] In some embodiments, ICS 155 evacuation conduit 152
comprises one or more sensors 302 that communicate operating
parameters e.g., lumen pressure and flow of matter in evacuation
conduit 152 lumen to IWS 126 processor 124. In some instances, for
example, ICS 100 encounters partial or full blockage of evacuation
conduit 152 that is reflected by a fall in pressure in the lumen of
evacuation conduit 152 sensed by sensor 302 and communicated to IWS
126. IWS 126 is configured to automatically activate ICS 155 based
on the received parameters to supplement cleansing operation of ICS
155.
[0111] In another example: in some instances during a procedure
IECS 100 encounters excessive amounts of matter requiring
supplemental suction and evacuation in which case and as depicted
in FIGS. 3A-3C by an arrow designated reference numeral 350, IWS
155 additionally and optionally is configured to activate EWS 150
one or more valves 138 and/or 140 as needed.
[0112] In the exemplary embodiment depicted in FIG. 3B, ICS is
activated and receives information regarding operating parameters
of the ICS from one or more ICS sensors. In some embodiments, the
data is received in a continuous or intermittent manner. In FIG. 3B
the operating parameter comprises a pressure parameter indicating
e.g., pressure inside ICS evacuation conduit 152. A fall in
pressure (a "Low" indication) may indicate partial or complete
blockage of the evacuation conduit 152 bringing ICS 155 IWS 126 to
activate ECS 150 to evacuate matter e.g., from a colon.
[0113] In the exemplary embodiment depicted in FIG. 3C, ICS is
activated and receives information regarding operating parameters
of the ICS from one or more ICS sensors. In some embodiments, the
data is received in a continuous or intermittent manner. In FIG. 3C
the operating parameter comprises a matter volume parameter
indicating e.g., high volume of matter inside ICS evacuation
conduit 152. Hi volume indication (a "HI" indication) may indicate
e.g., too high a volume of matter in a colon for ICS 155 evacuation
conduit 152 to evacuate alone bringing ICS 155 IWS 126 to activate
ECS 150 to evacuate excessive matter from the colon.
[0114] Although drawn separately for purposes of presentation in
FIG. 3A, it should be understood that in some embodiments, ICS 155
group 206 and ECS 150 group 204 share one or more tubes, for
example as described in relation to FIG. 2B, FIG. 9 and/or FIG. 1,
herein.
EWS/IWS "Smart" Master/Slave Mode of Operation
[0115] Reference is now made to FIGS. 4A, 4B and 4C collectively
referred to as FIG. 4, which are simplified block diagrams of a
mode of operation of IECS 100 in accordance with some embodiments
of the invention. As shown in the exemplary embodiment depicted in
FIGS. 4A-4C, in some embodiments, mode of operation toggle switch
142 is optionally set to operate ECS 150 and ICS 155 in a
respectively Master/Slave mode of operation. Alternatively and
optionally, mode of operation toggle switch 142 is optionally set
to operate ICS 155 and ECS 150 in a respectively Master/Slave mode
of operation.
[0116] In some embodiments, a lumen of at least one of ECS 150
working channel 134 and ICS 155 evacuation conduit 152 comprises
one or more sensors disposed in one or more corresponding
[0117] ECS 150 and ICS 155 components being in data communication
with corresponding EWS 106 and IWS 126. In some embodiments, the
one or more sensors comprise at least one of a pressure sensor,
contact sensor and flowmeter. In the exemplary configuration
depicted in FIGS. 4A-C, a sensor 402 is disposed in a lumen of
working channel 134 providing EWS 106 processor 114 data regarding
working channel 134 operating parameters e.g., lumen pressure and
flow of matter in working channel 134 lumen. In some embodiments,
sensor 402 is configured to alert EWS 106 processor 114 when lumen
of working channel 134 is blocked e.g., by a tool. In some
embodiments, the operating parameters include parameters
originating from function group 202 e.g., image acquisition data as
indicated in FIGS. 4A-4C by an arrow 456.
[0118] In the configuration depicted in FIGS. 4A-4C, ECS 150 is
activated and operating parameters described elsewhere herein are
communicated e.g., from sensor 402 and/or valves 138/140 to EWS 106
processor 114 as indicated by arrow 450 and from EWS 106 processor
114 to IWS 126 processor 124 indicated by arrow 454. Additionally
and optionally, operating parameters, e.g., rate of flow, fluid
level, fluid weight and fluid pressure are communicated from ECS
150 components e.g., from EWS 106 air 108 and/or water 110 sources
to EWS 106 processor 114 as indicated by arrow 452 and from EWS 106
processor 114 to IWS 126 processor 124 indicated by arrow 454.
Additionally and optionally, operating parameters, e.g., image
information, are communicated from ECS 150 function group 202
components e.g., camera (not shown) to EWS 106 processor 114
indicated by arrow 456 and from EWS 106 processor 114 to IWS 126
processor 124 indicated by arrow 454.
[0119] In the exemplary embodiment shown in FIGS. 4A-4C, IWS 126
processor 124 is configured to process the operating parameters
received from EWS 106 processor 114 as explained elsewhere herein
and automatically activate ICS 155 based on the received
parameters. For example and in some embodiments, in a colonoscopy
procedure, following introduction and advancement of IECS 100 into
the colon, a user 250 employs function group 202 to image the colon
as IECS 100 is gradually retracted from the cecum and gradually out
of the colon. In some instances, ICS 155 is activated e.g., to
cleanse the colon in areas in which a field of view is blocked by
colon lumen matter e.g., fecal matter.
[0120] In some instances the ability of ECS cleaning operation is
insufficient and requires supplementary cleaning and/or agitation
and break up of matter in the imaged lumen. In some embodiments,
IWS 126 receives operating parameters, e.g., image information,
communicated from ECS 150 function group 202 components e.g.,
camera (not shown) via EWS 106 processor 114. IWS 126 is configured
to automatically activate ICS 155 based on the received operating
parameters e.g., image information to supplement cleansing
operation of ECS 150. Once parameters return to acceptable levels
e.g., clear received image, indicating that supplemental cleansing
is no longer needed, IWS 126 is configured to automatically stop
ICS 155 activity based on the received operating parameters.
[0121] In another example, in some instances working channel 134 is
clogged or blocked by matter suctioned from lumen of a colon. A
fall in pressure in a lumen of working channel 134 is sensed by a
sensor e.g., sensor 402, and communicated to IWS 126 via EWS 150.
IWS 126 is configured to automatically activate ICS 155 based on
the received parameters to supplement cleansing operation of ECS
150. Once parameters return to acceptable levels e.g., working
channel 134 lumen pressure is normal, indicating that supplemental
cleansing is no longer needed, IWS 126 is configured to
automatically stop ICS 155 activity based on the received operating
parameters.
[0122] In the exemplary embodiment depicted in FIG. 4B, ECS 150 is
activated and ICS 155 receives information regarding operating
parameters of ECS from one or more ECS sensors. In some
embodiments, the data is received in a continuous or intermittent
manner. In FIG. 4B the operating parameter comprises a pressure
parameter indicating e.g., pressure inside ECS working channel 134.
A fall in pressure (a "Low" indication) may indicate partial or
complete blockage of the working channel 134 bringing ICS 155 IWS
126 to activate ICS 155 to evacuate matter via ICS evacuation
conduit 152; e.g., from a colon.
[0123] In the exemplary embodiment depicted in FIG. 4C, ECS 150 is
activated and ICS 155 receives information regarding operating
parameters of ECS 150 from one or more ECS sensors. In some
embodiments, the data is received in a continuous or intermittent
manner. In FIG. 4C the operating parameter comprises a matter
volume parameter indicating, e.g., a high volume of matter inside
ECS working channel 134. Hi volume indication (a "HI" indication)
may indicate e.g., too high a volume of matter in a colon for ECS
150 working channel 134 to evacuate alone bringing ICS 155 IWS 126
to activate ICS 150 evacuation channel 152 to evacuate excessive
matter from the colon.
[0124] Although drawn separately for purposes of presentation in
FIG. 4A, it should be understood that in some embodiments, ICS 155
group 206 and ECS 150 group 204 share one or more tubes, for
example as described in relation to FIG. 2B, FIG. 9 and/or FIG. 1,
herein.
EWS/IWS Master/Slave Mode of Operation
[0125] Reference is now made to FIGS. 5A, 5B and 5C collectively
referred to as FIG. 5, which are simplified block diagrams of a
mode of operation of IECS 100 in accordance with some embodiments
of the invention. As shown in the exemplary embodiment depicted in
FIGS. 5A-5C, in some embodiments, mode of operation toggle switch
142 is optionally set to operate ECS 150 and ICS 155 in a
respectively Master/Slave mode of operation. Alternatively and
optionally, mode of operation toggle switch 142 is set to operate
ICS 155 and ECS 150 in a respectively Master/Slave mode of
operation.
[0126] In the exemplary configuration depicted in FIGS. 5A-5C, one
or more sensors 402 comprising at least one of a pressure sensor,
contact sensor and flowmeter are disposed in a lumen of working
channel 134. In some embodiments, one or more sensors 402 are
configured to provide EWS 106 processor 114 with operating
parameters regarding working channel 134; e.g., lumen pressure and
flow of matter in working channel 134 lumen. In some embodiments,
the operating parameters include parameters originating from
function group 202; e.g., image acquisition data as indicated in
FIGS. 5A-5C by an arrow 456.
[0127] In the configuration depicted in FIGS. 5A-5C, ECS 150 is
activated and operating parameters described elsewhere herein are
communicated e.g., from sensor 402 and/or valves 138/140 to EWS 106
processor 114 as indicated by arrow 550. Additionally and
optionally, operating parameters, e.g., rate of flow, fluid level,
fluid weight and fluid pressure are communicated from ECS 150 EWS
106 components e.g., air 108 and/or water 110 sources, to EWS 106
processor 114. Additionally and optionally, operating parameters,
e.g., image information, are communicated from ECS 150 function
group 202 components e.g., camera (not shown) to EWS 106 processor
114 indicated by arrow 456.
[0128] In the exemplary embodiment shown in FIGS. 5A-5C, EWS 106
processor 114 is configured to process the received operating
parameters and activate ICS 155 based on the received operating
parameters. For example and in some embodiments, in a colonoscopy
procedure, following introduction and advancement of IECS 100 into
the colon, a user 250 employs function group 202 to image the colon
as IECS 100 is gradually retracted from the cecum and gradually out
of the colon. In some instances, ICS 155 is activated e.g., to
cleanse the colon in areas in which a field of view is blocked by
colon lumen matter e.g., fecal matter.
[0129] In some instances the ability of ECS cleaning operation is
insufficient and requires supplementary cleaning and/or agitation
and break up of matter in the imaged lumen. In some embodiments,
EWS 106 is configured to automatically activate ICS 155 as
indicated by arrow 552 based on the received operating parameters
to supplement cleansing operation of ECS 150.
[0130] In another example, in some instances working channel 134 is
clogged or blocked by matter suctioned from lumen of a colon. A
fall in pressure in a lumen of working channel 134 is sensed by a
sensor e.g., sensor 402, and communicated to EWS 150. As described
elsewhere herein, EWS 106 is configured to automatically activate
ICS 155 as indicated by arrow 552 based on the received operating
parameters to supplement cleansing operation of ECS 150.
[0131] In reference to Master/Slave operating modes described
herein, at least one of ECS/ICS/EWS/IWS designated as a Master
operating system is operative to activate at least one of
corresponding ECS/ICS/EWS/IWS designated as a Slave operating
system continuously or intermittently and/or inactivate at least
one of corresponding ECS/ICS/EWS/IWS designated as a Slave
operating system when received operating parameters as described
elsewhere herein indicate that operation of a Slave operating
system is no longer required.
[0132] In the exemplary embodiment depicted in FIG. 5B, ECS 150 is
activated and receives information regarding operating parameters
of ECS from one or more ECS sensors. In some embodiments, the data
is received in a continuous or intermittent manner. In FIG. 5B the
operating parameter comprises a pressure parameter indicating e.g.,
pressure inside ECS working channel 134. A fall in pressure (a
"Low" indication) may indicate partial or complete blockage of the
working channel 134 bringing ECS 150 EWS 116 to activate ICS 155 to
evacuate matter via ICS evacuation conduit 152; e.g., from a
colon.
[0133] In the exemplary embodiment depicted in FIG. 5C, ECS 150 is
activated and receives information regarding operating parameters
of ECS 150 from one or more ECS sensors. In some embodiments, the
data is received in a continuous or intermittent manner. In FIG. 5C
the operating parameter comprises a matter volume parameter
indicating, e.g., a high volume of matter inside ECS working
channel 134. Hi volume indication (a "HI" indication) may indicate
e.g., too high a volume of matter in a colon for ECS 150 working
channel 134 to evacuate alone bringing ECS 150 EWS 116 to activate
ICS 150 evacuation channel 152 to evacuate excessive matter from
the colon.
[0134] Reference is now made to FIG. 6, which is a simplified block
diagram of an IECS mode of operation toggle switch in accordance
with some embodiments of the invention. In the exemplary embodiment
depicted in FIG. 6 toggle switch 142 is configured to select
between one or more modes of operation including: (a) Off mode 602
in which IECS 100 is turned off. (b) ECS mode 604--in which only
ECS 150 is activated (c) ICS mode 606--in which only ICS 155 is
activated. (d) ICS/ECS I Master/Slave mode 608--in which ICS 155 is
activated and is configured to automatically optionally
continuously or intermittently activate ECS 150 valves 138/140 as
explained elsewhere herein. (e) ECS/ICS I Master/Slave mode 610--in
which ECS 150 is activated and is configured to automatically
optionally continuously or intermittently activate ICS 155 valves
144/146 as explained elsewhere herein. (f) ICS/ECS II Master/Slave
mode 612--in which ICS 155 is activated and is configured to
automatically optionally continuously or intermittently activate
ECS 150. (g) ECS/ICS II Master/Slave mode 614--in which ECS 150 is
activated and is configured to automatically optionally
continuously or intermittently activate ICS 155. (h) "Smart"
ICS/ECS Master/Slave mode 616--in which ICS 155 is activated and
automatically optionally continuously or intermittently ECS 150 is
activated by processor 114 based on received operating parameters
from ICS 155 as explained elsewhere herein. (i) "Smart" ECS/ICS
Master/Slave mode 618--in which ECS 150 is activated and
automatically optionally continuously or intermittently ICS 155 is
activated by processor 124 based on received operating parameters
from ECS 150 as explained elsewhere herein.
[0135] Although drawn separately for purposes of presentation in
FIG. 5A, it should be understood that in some embodiments, ICS 155
group 206 and ECS 150 group 204 share one or more tubes, for
example as described in relation to FIG. 2B, FIG. 9 and/or FIG. 1,
herein.
[0136] Reference is now made to FIGS. 7A and 7B; which are a
simplified flow chart of implementation of IECS 100 in a
colonoscopy procedure in accordance with some embodiments of the
invention. A colonoscopy procedure commonly requires preparation to
cleanse out the content of the colon and to allow proper imaging of
the colon wall. However, in some instances, preparation is
incomplete, insufficient or has not been done at all. In such
circumstances a colonoscopy comprises at least two phases: a
cleansing phase that is carried out concurrently with the
introduction of the colonoscope into the colon and an imaging phase
that follows the cleansing phase and is commonly carried out during
the colonoscope withdrawal from the colon.
[0137] As explained in greater detail elsewhere herein, IECS 100
comprises an ICS 155 configured to agitate and break down colon
lumen fecal matter so to enable effective evacuation of the matter
out of the colon.
[0138] In some embodiments and as described elsewhere herein, an
exemplary and optional method of implementing IECS 100 in a
colonoscopy procedure comprises at 702 introducing IECS 100 into a
colon and adjusting at 704 IECS mode of operation toggle switch 142
to ICS/ECS Master/Slave mode of operation 606/612 and activating
ICS 155 at 706. The method further comprises at 708 guiding IECS
100 through the colon while concurrently cleansing the colon with
ICS 155. At 710 optionally activating or inactivating ECS 150
optionally automatically as needed throughout the advancement of
IECS 100 to supplement the cleansing operation of ICS 155 and
reaching the cecum at 712. This completes the cleansing phase of
the colon at which time the imaging phase of the method begins at
714 in adjusting IECS mode of operation toggle switch 142 to
ECS/ICS Master/Slave mode of operation 610/614 and at 716 starting
image acquisition while gradually retracting IECS 100 in the colon
away from the cecum. Optionally, at 718, activating ECS 150 and
optionally at 720 activating or inactivating ICS 155 optionally
automatically as needed throughout the retraction of IECS 100 along
and out of the colon to supplement the cleansing operation of ECS
150 until fully removing IECS 100 from the colon at 722.
IECS Interface Portion
[0139] Reference is now made to FIGS. 8A and 8B, which are part
block diagram, cross-section view, simplified illustrations of an
IECS interface in accordance with some embodiments of the
invention. As shown in FIG. 8A and described in detail elsewhere
herein, IECS 100 comprises at least three function groups:
Endoscope operating function group 202, ECS 150 function group 204
and ICS 155 function group 206.
[0140] In some embodiments, and as shown in the exemplary
embodiment depicted in FIG. 8A, ICS 155 function group 206
including one or more irrigation fluid supply tubes 154; e.g., air
and/or water supply tubes, coupled to air 128 and/or water 120
sources, one or more evacuation conduits 152 in fluid communication
with vacuum source 122 and optionally a sensor (e.g., sensor 302)
associated circuitry 1008 in communication with IWS 126 processor
124 enter IECS 100 insertion tube 118 via IECS interface 116 via at
least one umbilical cable 136 between ICS Working Station (IWS) 126
and IECS 100 interface 116.
[0141] Umbilical cable 136 terminates at the IECS 100 end at a
quick release coupling 802 configured to couple to an entry port
804 of interface 116. In some embodiments, umbilical cable 136 is
disposable.
[0142] Optionally, in some embodiments and as shown in FIG. 8B,
interface 116 comprises a flexible joint 806 configured to allow
flexion and extension of interface 116 branch 808 and increase
comfort of coupling interface 116 and umbilical cable 136.
Insertion Tube Components
[0143] Reference is now made to FIG. 9, which is a cross-section
view simplified illustration of IECS insertion tube in accordance
with some embodiments of the invention.
[0144] In some embodiments, and as shown in the exemplary
embodiment depicted in FIG. 9, in which a cross-section of
insertion tube 118 is taken along section A-A, insertion tube 118
comprises endoscope operating function group 202 comprising at
least one or more endoscope navigation cables 902, light bundle
1004 and image acquisition camera cable 906.
[0145] Additionally and optionally, in some embodiments, insertion
tube 118 comprises endoscope operating function group 204
comprising at least one or more suction/working channels 134 and
one or more irrigation and/or air 178/water 170 supply tubes
coupled to air 108 and/or water 110 sources.
[0146] As shown in the exemplary embodiment depicted in FIG. 9,
insertion tube 118 comprises ICS 155 function group 206 including
one or more irrigation or fluid supply tubes 154; e.g., air and/or
water supply tubes, one or more evacuation conduits 152 in fluid
communication with vacuum source 122 and optionally a sensor (e.g.,
sensor 302) and sensor 302 associated circuitry 908.
[0147] In some embodiments, ICS 155 function group 206 and
endoscope operating function group 204 are configured to at least
partially overlap in the tubes belonging to each, and share control
of evacuation and/or fluid supply. In some embodiments, evacuation
tube 152 joins to (and optionally comprises or is identical to)
working channel 134, with one or both of working channel 134 and
evacuation tube 152 being joined (e.g., by means of a Y-tube
connection) to both the EWS 106 (e.g., via control valve 138) and
to the IWS 126 (e.g., via control valve 146). Additionally or
alternatively, in some embodiments, fluid supply tube 154 joins to
(and optionally comprises or is identical to) fluid supply tube
148, with one or both of fluid supply tube 148 and fluid supply
tube 154 being joined (e.g., by means of a Y-tube connection) to
the EWS 106 (e.g., via control valve 140) and to the IWS 126 (e.g.,
via control valve 144).
[0148] In some embodiments, a diameter of insertion tube 118 is
between 17 and 22 mm, between 18 and 20 mm, less than 17 mm, more
than 22 mm or any diameter in between. In some embodiments, a
diameter of insertion tube 118 is equal to 19 mm. In some
embodiments, a diameter of insertion tube 118 is less than 19 mm.
In some embodiments, one or more evacuation conduits 152 comprises
a diameter in the range between 2 and 10 mm, 4 and 8 mm or 5-6 mm,
less than 2 mm or more than 10 mm and any diameter in between. In
some embodiments, the diameter of evacuation conduits 152 is
between 5.4 mm and 6.0 mm. In FIG. 9, the components of insertion
tube 118 are depicted distanced from one another for clarity of
explanation. In some embodiments, the components of insertion tube
118 are positioned in close proximity to reduce the diameter of
insertion tube 118 as much as possible e.g., less than 20 mm.
[0149] As shown in FIG. 10, which is a perspective view simplified
illustration of endoscope insertion tube 118 bendable portion 132
in accordance with some embodiments of the invention, in some
embodiments, bendable portion 132 is configured to be driven by one
or more endoscope navigation cables 902 and bend radially at least
up to 180 degrees in vertical (up and down) directions and at least
up to 160 degrees in horizontal (left and right) directions to aim
distal end tip 130 in a desired direction.
[0150] In some embodiments, bendable portion 132 comprises a
braided or ribbed wall 1002 made of a resilient material e.g.,
rubber. In some embodiments, bendable portion 132 comprises a
spiral form wall.
[0151] In some embodiments, all tubes housed within insertion tube
118 and bendable portion 132 represented in FIG. 10 by tubes 1004
are made of resilient materials and are bendable in accordance with
the bending of bendable portion 132.
[0152] FIG. 11 is a perspective view simplified illustration of an
IECS distal tip 130 in accordance with some embodiments of the
current invention, viewed from aspect of the back surface depicting
attachment ports of bendable portion 132 components. As shown in
FIG. 11, an IECS distal tip 130 is configured to attach to a distal
tip of bendable portion 132 and comprises one or more light bundle
904 receiving ports 1104, one or more camera receiving ports 906,
one or more working channels 134 receiving port 1134, one or more
ports 1148 for receiving fluid supply tubes 148 comprising air 178
and/or water 170 supply tubes, one or more evacuation tubes 152
receiving port 1152, one or more sensor 302 circuitry 908 receiving
port 1108 and one or more air 128 and/or water 120
supply/irrigation tubes receiving ports and/or fluid jet nozzles
1102.
General
[0153] The terms "comprises", "comprising", "includes",
"including", "has", "having" and their conjugates mean "including
but not limited to".
[0154] The term "consisting of" means "including and limited
to".
[0155] The term "consisting essentially of" means that the
composition, method or structure may include additional
ingredients, steps and/or parts, but only if the additional
ingredients, steps and/or parts do not materially alter the basic
and novel characteristics of the claimed composition, method or
structure.
[0156] Throughout this application, embodiments of this invention
may be presented with reference to a range format. It should be
understood that the description in range format is merely for
convenience and brevity and should not be construed as an
inflexible limitation on the scope of the invention. Accordingly,
the description of a range should be considered to have
specifically disclosed all the possible subranges as well as
individual numerical values within that range. For example,
description of a range such as "from 1 to 6" should be considered
to have specifically disclosed subranges such as "from 1 to 3",
"from 1 to 4", "from 1 to 5", "from 2 to 4", "from 2 to 6", "from 3
to 6", etc.; as well as individual numbers within that range, for
example, 1, 2, 3, 4, 5, and 6. This applies regardless of the
breadth of the range.
[0157] Whenever a numerical range is indicated herein (for example
"10-15", "10 to 15", or any pair of numbers linked by these another
such range indication), it is meant to include any number
(fractional or integral) within the indicated range limits,
including the range limits, unless the context clearly dictates
otherwise. The phrases "range/ranging/ranges between" a first
indicate number and a second indicate number and
"range/ranging/ranges from" a first indicate number "to", "up to",
"until" or "through" (or another such range-indicating term) a
second indicate number are used herein interchangeably and are
meant to include the first and second indicated numbers and all the
fractional and integral numbers therebetween.
[0158] Unless otherwise indicated, numbers used herein and any
number ranges based thereon are approximations within the accuracy
of reasonable measurement and rounding errors as understood by
persons skilled in the art.
[0159] As used herein the term "method" refers to manners, means,
techniques and procedures for accomplishing a given task including,
but not limited to, those manners, means, techniques and procedures
either known to, or readily developed from known manners, means,
techniques and procedures by practitioners of the medical arts.
[0160] As used herein, the term "treating" includes abrogating,
substantially inhibiting, slowing or reversing the progression of a
condition, substantially ameliorating clinical or aesthetical
symptoms of a condition or substantially preventing the appearance
of clinical or aesthetical symptoms of a condition.
[0161] It is appreciated that certain features of the invention,
which are, for clarity, described in the context of separate
embodiments, may also be provided in combination in a single
embodiment. Conversely, various features of the invention, which
are, for brevity, described in the context of a single embodiment,
may also be provided separately or in any suitable subcombination
or as suitable in any other described embodiment of the invention.
Certain features described in the context of various embodiments
are not to be considered essential features of those embodiments,
unless the embodiment is inoperative without those elements.
[0162] In addition, any priority document(s) of this application
is/are hereby incorporated herein by reference in its/their
entirety.
[0163] It is the intent of the applicant(s) that all publications,
patents and patent applications referred to in this specification
are to be incorporated in their entirety by reference into the
specification, as if each individual publication, patent or patent
application was specifically and individually noted when referenced
that it is to be incorporated herein by reference. In addition,
citation or identification of any reference in this application
shall not be construed as an admission that such reference is
available as prior art to the present invention. To the extent that
section headings are used, they should not be construed as
necessarily limiting. In addition, any priority document(s) of this
application is/are hereby incorporated herein by reference in
its/their entirety.
* * * * *