U.S. patent application number 13/703986 was filed with the patent office on 2013-04-04 for systems and methods for cleaning body cavities.
This patent application is currently assigned to Motus GI Medical Technologies Ltd.. The applicant listed for this patent is Alexander Banzger, Noam Hassidov, Alexey Morochovsky, Boris Shtul. Invention is credited to Alexander Banzger, Noam Hassidov, Alexey Morochovsky, Boris Shtul.
Application Number | 20130085442 13/703986 |
Document ID | / |
Family ID | 44628493 |
Filed Date | 2013-04-04 |
United States Patent
Application |
20130085442 |
Kind Code |
A1 |
Shtul; Boris ; et
al. |
April 4, 2013 |
SYSTEMS AND METHODS FOR CLEANING BODY CAVITIES
Abstract
This application presents methods and devices for continuously
cleaning a colon by at least partially filling a segment of the
colon with liquid and agitating the fluid to dislodge matter
adhering to the colon walls. Methods for automatic maintenance of
liquid levels in the colon during continuous cleaning are
taught.
Inventors: |
Shtul; Boris; (Moshav
Zerufa, IL) ; Morochovsky; Alexey; (Haifa, IL)
; Banzger; Alexander; (Nesher, IL) ; Hassidov;
Noam; (Moshav Bustan Hagalil, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Shtul; Boris
Morochovsky; Alexey
Banzger; Alexander
Hassidov; Noam |
Moshav Zerufa
Haifa
Nesher
Moshav Bustan Hagalil |
|
IL
IL
IL
IL |
|
|
Assignee: |
Motus GI Medical Technologies
Ltd.
Nazareth
IL
|
Family ID: |
44628493 |
Appl. No.: |
13/703986 |
Filed: |
June 13, 2011 |
PCT Filed: |
June 13, 2011 |
PCT NO: |
PCT/IL11/00470 |
371 Date: |
December 13, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61354226 |
Jun 13, 2010 |
|
|
|
61378432 |
Aug 31, 2010 |
|
|
|
Current U.S.
Class: |
604/28 ;
604/30 |
Current CPC
Class: |
A61M 3/0204 20140204;
A61M 2210/1064 20130101; A61M 3/0283 20130101; A61B 1/015 20130101;
A61B 2017/00296 20130101; A61M 1/006 20140204; A61M 3/0229
20130101; A61M 3/0208 20140204; A61B 17/32037 20130101; A61B 1/31
20130101; A61B 2017/22037 20130101; A61B 1/126 20130101; A61M
3/0212 20140204; A61M 2205/50 20130101; A61M 3/022 20140204 |
Class at
Publication: |
604/28 ;
604/30 |
International
Class: |
A61M 3/02 20060101
A61M003/02 |
Claims
1. A device for continuously cleaning a colon comprising: a fluid
input tube configured for insertion into an anal canal opening and
for supplying fluid to a colon segment being cleaned remote from
the anal canal opening; a material output tube through which liquid
and fecal matter may be removed from the colon segment; and a
controller configured to establish and maintain a condition while
continuously cleaning, in which said colon segment being cleaned is
mostly filled with a mixture of said liquid and said fecal matter;
wherein said fluid input tube is configured to supply fluid to the
colon segment while simultaneously allowing removal of liquid and
fecal matter from the colon segments via said material output
tube.
2. (canceled)
3. The device of claim 1, wherein said controller is programmed to
maintain within said colon segment a liquid fill level such that a
distal end of said device is fully submerged in said mixture.
4-6. (canceled)
7. The device of claim 1, wherein said cleaning comprises removing
feces at least 5 cm distal to said device.
8. The device of claim 1, wherein said controller is configured to
control at least one of a supply of liquid through said fluid input
tube and a flow of matter through said output tube; wherein said
supply and said flow are within a range of between 400 cc/min and
2000 cc/min.
9. The device of claim 1, further comprising at least one agitator
for agitating said mixture, wherein said agitator transfers an
amount of energy sufficient to at least one of dislodge fecal
matter from a wall of said colon and break-down relatively large
fecal matter into relatively smaller fecal matter; wherein said at
least one agitator is one of located outside said device and
located in at least one of said fluid input tube and said material
output tube.
10. (canceled)
11. The device of claim 9, wherein said agitator comprises a fluid
flow pulsator which alternates delivery of liquid within said input
tube and delivery of gas within said input tube, wherein a pressure
of said gas is at least 0.2 ATM above a pressure of said
liquid.
12-15. (canceled)
16. The device of claim 1, further comprising a size-reducer for
reducing size of said fecal matter passing into and through said
output tube.
17. The device of claim 1, wherein said controller is programmed to
control at least one of input flow and output flow in such a way
that one of: a) a pressure change inside said colon segment does
not exceed 0.06 Bar above an ambient pressure; b) a pressure change
inside said colon segment and proximate to a distal end of said
device does not fall 0.20 Bar below an ambient pressure; and c)
pressure inside said colon segment and proximate to a distal end of
said device is maintained within a range of 30 mbar-76 mbar.
18-19. (canceled)
20. The device of any claim 1, further characterized in that said
device cleans at least 90% of feces from said colon segment while
advancing in said colon at least at 10 cm per minute.
21. (canceled)
22. The device of claim 1, further comprising a filter coupled to
said outlet tube, wherein an opening to said outlet tube is larger
than openings in said filter.
23. The device of claim 1, wherein said filter comprises a
plurality of openings substantially parallel to a direction of
motion of said device, wherein said motion of device inside said
colon dislodges feces trapped in said openings.
24. The device of claim 1, wherein said material output tube
further comprises a plurality of lobes running side by side and in
fluid communication with each other along at least a portion of a
length of said material output tube; and one of: a) a rotatable
device housed in one of said lobes and free to rotate within said
lobe, but prevented by shape of said lobe from moving laterally
into another of said plurality of lobes, wherein said rotatable
device is selected from a helical device, a paddle-shaped device, a
propeller-shaped device, and a brush-like device; and b) a
combination of: i. a first rotatable device positioned within a
first lobe of said output tube; ii. a second rotatable device
positioned within a second lobe of said output tube; and iii. a
mechanism for rotating said first and said second rotatable
devices; wherein said first and second rotatable devices are one of
helical devices, paddle-shaped devices, propeller-shaped devices,
and brush-like devices.
25. (canceled)
26. A device according to claim 1, further comprising a memory
coupled to said controller, said memory comprising a table
correlating at least one cleaning parameter with at least one other
parameter, wherein said parameters are selected from input/output
fluid flow rates, liquid rotation rate, cleaning rate, cleaning
efficiency, working pressure, a rate of rotation of
crushing/shredding elements.
27. (canceled)
28. A method for cleaning a colon, comprising: from an anal canal
opening, filling a volume of a segment of the colon remote from the
anal canal opening with a liquid to be mostly full; agitating a
mixture of said liquid and feces; inserting additional liquid into
the colon segment while simultaneously removing said mixture from
the colon segment to maintain a condition in which said colon
segment is mostly full; and emptying said liquid from said
segment.
29. (canceled)
30. The method of claim 28, wherein maintaining comprises
maintaining said mostly full state according to changes in
dimensions of said colon segment.
31. The method of claim 28, wherein said agitating comprises
applying an amount of energy to said mixture in an omni-directional
manner.
32. The method of claim 28, wherein said agitating comprises
transferring a sufficient amount of energy to at least one of
dislodge fecal matter from at least some of the surface area of
walls of said segment and break-down at least some of the volume of
relatively large fecal matter blocks inside said segment.
33. (canceled)
34. The method of claim 28, further comprising progressively
advancing a colon cleaning device along a length of said colon at a
rate of at least 10 cm/second while maintaining said volume of said
segment.
35-38. (canceled)
39. The method of claim 28, wherein said agitating comprises
vibrating said mixture in said colon segment at a frequency of
33-120 Hz.
40-41. (canceled)
42. The method of claim 28, further comprising at least one of
pulling, pushing, cutting, graining, tearing, and shredding of
pieces of fecal matter to an average size of less than 1 mm.
43. (canceled)
44. The method of claim 28, further comprising controlling at least
one of said filling, said agitating, said inserting and said
emptying to clean at least 95% of the inner surface area of the
colon segment.
45. (canceled)
46. A device according to claim 9 wherein said at least one
agitator is configured for transferring a sufficient amount of
energy to at least one of dislodge fecal matter from at least 50%
of the surface area of the wall and break-down at least 50% of the
volume of the relatively large fecal matter.
47-48. (canceled)
49. A device for cleaning a colon segment remote from an anal canal
opening comprising: a) a material output tube through which liquid
and fecal matter may be removed, said tube extending from outside
the colon to the colon segment; and b) a fluid flow pulsator
configured for insertion into the anal canal opening which supplies
alternating pulses of pressurized liquid alternating with
pressurized gas, wherein a pressure of said gas is at least 0.2
atmospheres above a pressure of said liquid, and a rate of input of
said liquid into the colon segment is at least 400 cc/min; wherein
said pressure of said liquid is substantially equal to an ambient
pressure of a liquid-fecal mixture inside the colon segment; and
wherein the colon segment being cleaned is at least 60% filled with
said liquid-fecal mixture.
50. (canceled)
51. A device according to claim 22, wherein a dimension of said
openings substantially perpendicular to said long axis of said
device is at least 3 mm.
52. The device according to claim 1, wherein said device is at
least 60 cm in length and is capable of cleaning a colon at a rate
of 15 cm per minute; wherein said fluid input tube is configured to
deliver at least 0.7 liters per minute into the colon at a distal
end of said input tube; and wherein said material output tube
encloses a. a mechanism for reducing matter chunks entering said
input tube to sizes of less than 1.0 mm; and b. a transport
mechanism capable of removing material from the colon to outside as
body at a rate of at least one liter per minute; and c. a
controller programmed to control input flow and output flow so as
to establish and maintain a condition in which a colon portion
being cleaned is at least 60% filled with liquid.
53. (canceled)
54. The device according to claim 9, wherein said agitator is
configured to cause at least one of: agitation of said mixture
relatively in front of said device; and agitation of said mixture
surrounding said device.
55. The device according to claim 9, wherein said agitator is
configured to cause at least one of flow and motion of said
mixture, wherein said at least one of flow and motion is at least
one of motion caused by shock waves and pulsating forces.
56. The device according to claim 1, further comprising a pump
configured to provide reverse flow in said material output tube.
Description
RELATED APPLICATIONS
[0001] This is a PCT application which claims the benefit of
priority of U.S. Provisional Patent Application No. 61/378,432
filed Aug. 31, 2010, and U.S. Provisional Patent Application No.
61/354,226 filed Jun. 13, 2010, the contents of which are
incorporated herein by reference in their entirety.
FIELD AND BACKGROUND OF THE INVENTION
[0002] The present invention, in some embodiments thereof, relates
to devices and methods for cleaning body cavities and, more
particularly, but not exclusively, to devices and methods for
cleaning a human colon.
[0003] Use of an enema for cleaning a portion of the colon has been
known for many centuries. Enemas typically insert water into the
rectum through a short nozzle, and clean up to about 60 cm of the
lower colon, the sigmoid colon. "Hydrotheraphy" systems using a
short nozzle that inserts purified water in to the human colon as
high as the cecum (150-180 cm) can clean the entire colon. This
process takes up to one hour per session and in some cases several
cleansing sessions are needed. The process can be uncomfortable and
inconvenient for that reason. Early attempts to insert long
flexible tubes into the colon to enhance the cleansing process,
without a camera or other visual guidance system and often
practiced by operators without proper training, were found to
damage the colon walls, sometimes causing fatal perforations.
[0004] Patients requiring endoscopic observation of the colon
undergo pharmacological (laxative) colon preparation prior to the
endoscopic exam, using agents that generate massive bowel
movements. However, by one current estimate such preparation is
found to effectively cleanse the colon wall in only about 75% of
the patients who use it.
[0005] In an additional recent and contemporary practice, an
endoscope (colonoscope) is inserted in the lower intestine and is
used to clean the colon as well as to observe the colon after
cleaning. A colonoscope typically comprises a camera for viewing
the intestinal cavity, a pressurized water delivery system for
aiming a stream of water at a concentration of fecal matter visible
through the camera, and a suction device which may be directed
towards a portion of fecal matter dislodged from the intestinal
wall so as to aspirate the dislodged matter and transport it out of
the body. Various devices fitting this description are well known
in the art, and are used to prepare the colon for diagnostic visual
inspection by a surgeon.
[0006] In a typical procedure, when a GI physician using a
colonoscope encounters fecal matter blocking the colonoscope view,
he may steer the colonoscope tip until he has a good view of the
fecal matter via the colonoscope's onboard camera, and will then
inject water to dislodge the fecal matter, and then aspirate the
dissolved fecal matter out of the body. Auxiliary pumps are
sometimes used to generate high vacuum levels and powerful water
jets. Internal lumens of the colonoscope may be used for inputting
water and outputting fecal matter, or a multi-lumen external
apparatus may be attached to the colonoscope to provide high
throughput and to free the colonoscope's working channel(s) for
other tasks. PCT application WO2009/143201 (Gordon et al.) teaches
a system of this type. Alternatively, use of a special nozzle to
produce high water pressure at the distal tip of a colonoscope
working channel is taught in PCT Application WO2009/125387 (by
Nitsan et al).
SUMMARY OF THE INVENTION
[0007] The present invention, in some of its embodiments, provides
methods and devices for more effective cleaning of the colon or
other body cavities, which methods and devices require less
operator effort, are faster, and are more effective than methods of
prior art.
[0008] There is provided in accordance with an exemplary embodiment
of the invention a device for continuously cleaning a colon
comprising:
[0009] a. a fluid input tube for supplying fluid to a colon segment
being cleaned;
[0010] b. a material output tube through which liquid and fecal
matter may be removed from the colon; and
[0011] c. a controller configured to establish and maintain a
condition while continuously cleaning, in which the colon segment
being cleaned is mostly filled with a mixture of the liquid and the
fecal matter.
[0012] In an exemplary embodiment of the invention, mostly filled
comprises at least 60% filled.
[0013] In an exemplary embodiment of the invention, the controller
is programmed to maintain within the colon segment a liquid fill
level such that a distal end of the device is fully submerged in
the mixture.
[0014] In an exemplary embodiment of the invention, the maintain
comprises maintaining the mostly filled colon segment according to
changes in dimensions of the colon segment.
[0015] In an exemplary embodiment of the invention, the colon
segment comprises a volume of 50 mL to 500 mL.
[0016] In an exemplary embodiment of the invention, the
continuously cleaning comprises at least one of an exchange of
fluid between the device and the colon segment and agitation of the
fluid.
[0017] In an exemplary embodiment of the invention, the cleaning
comprises removing feces at least 5 cm distal to the device.
[0018] In an exemplary embodiment of the invention, the controller
is configured to control at least one of [0019] a supply of liquid
through the fluid input tube, and [0020] a flow of matter through
the output tube, wherein the supply and the flow comprise a range
of between 400 cc/min and 2000 cc/min.
[0021] In an exemplary embodiment of the invention, the device
further comprises an agitator for agitating the mixture, wherein
the agitator transfers an amount of energy sufficient to at least
one of dislodge fecal matter from a wall of the colon and
break-down relatively large fecal matter into relatively smaller
fecal matter. Optionally, the material output tube comprises the
agitator. Optionally, the agitator comprises a fluid flow pulsator
which alternates delivery of liquid within the input tube and
delivery of gas within the input tube, wherein a pressure of the
gas is at least 0.2 ATM above a pressure of the liquid. Optionally,
the fluid input tube comprises the fluid flow pulsator.
Alternatively or additionally, the agitator comprises a rotating
element comprised within the output tube. Alternatively or
additionally, the agitator comprises a vibration element for
inducing vibration in the mixture. Alternatively or additionally,
the agitator comprises a plurality of nozzles, the nozzles are
offset from a longitudinal axis of the device, the nozzles
positioned and aimed to induce a rotational movement in the
mixture.
[0022] In an exemplary embodiment of the invention, the device
further comprises a size-reducer for reducing size of the fecal
matter passing into and through the output tube.
[0023] In an exemplary embodiment of the invention, the controller
is programmed to control at least one of input flow and output flow
in such a way that a pressure change inside the colon segment does
not exceed 0.06 Bar above an ambient pressure.
[0024] In an exemplary embodiment of the invention, the controller
is programmed to control at least one of input flow and output flow
in such a way that a pressure change inside the colon segment and
proximate to a distal end of the device does not fall 0.20 Bar
below an ambient pressure.
[0025] In an exemplary embodiment of the invention, the controller
is programmed to control at least one of input flow and output flow
in such a way that pressure inside the colon segment and proximate
to a distal end of the device is maintained within a range of 30
mbar-76 mbar.
[0026] In an exemplary embodiment of the invention, the device
cleans at least 90% of feces from the colon segment while advancing
in the colon at least at 10 cm per minute.
[0027] In an exemplary embodiment of the invention, the device is
an add-on to a colonoscope.
[0028] In an exemplary embodiment of the invention, the device
further comprises a filter coupled to the outlet tube, wherein an
opening to the outlet tube is larger than openings in the filter.
Optionally, the filter comprises a plurality of openings
substantially parallel to a direction of motion of the device,
wherein the motion of device inside the colon dislodges feces
trapped in the openings.
[0029] In an exemplary embodiment of the invention, the material
output tube further comprises:
[0030] a) plurality of lobes running side by side and in fluid
communication with each other along at least a portion of a length
of the material output tube; and
[0031] b) at least one rotatable device housed in one of the lobes
and free to rotate within the lobe, but prevented by shape of the
lobe from moving laterally into another of the plurality of lobes.
Optionally, the material output tube further comprises:
[0032] a) a first helical device positioned within a first lobe of
the output tube;
[0033] b) a second helical device positioned within a second lobe
of the output tube; and
[0034] c) a mechanism for rotating the first and the second helical
devices in tandem.
[0035] In an exemplary embodiment of the invention, the device
further comprises a memory coupled to the controller, the memory
comprising a table correlating at least one cleaning parameter with
at least one other parameter.
[0036] There is provided in accordance with an exemplary embodiment
of the invention a method of cleaning a colon comprising advancing
at a speed greater than 10 cm per minute a distal end of a cleaning
device, which distal end removes more than 95% of feces initially
contained within colon segments within which the device
advances.
[0037] There is provided in accordance with an exemplary embodiment
of the invention a method for cleaning a colon, comprising:
[0038] filling a volume of a segment of the colon with a liquid to
be mostly full;
[0039] agitating a mixture of the liquid and feces;
[0040] inserting additional liquid into the colon segment while
simultaneously removing the mixture from the colon segment to
maintain a condition in which the colon segment is mostly full;
and
[0041] emptying the liquid from the segment.
[0042] In an exemplary embodiment of the invention, mostly full
comprises at least 60% full of the mixture.
[0043] In an exemplary embodiment of the invention, maintaining
comprises maintaining the mostly full state according to changes in
dimensions of the colon segment.
[0044] In an exemplary embodiment of the invention, agitating
comprises applying an amount of energy to the mixture in an
omni-directional manner. Optionally, agitating comprises
transferring a sufficient amount of energy to at least one of
dislodge fecal matter from at least some of the surface area of
walls of the segment and break-down at least some of the volume of
relatively large fecal matter blocks inside the segment.
Optionally, transferring a sufficient amount of energy comprises
transferring a sufficient amount of energy at least 10 cm from an
agitation device to the mixture.
[0045] In an exemplary embodiment of the invention, the method
further comprises progressively advancing a colon cleaning device
along a length of the colon at a rate of at least 10 cm/second
while maintaining the volume of the segment.
[0046] In an exemplary embodiment of the invention, the method
further comprises maintaining a pressure of the liquid in the colon
segment within a range of 30-76 mbar during the inserting and the
simultaneous removing.
[0047] In an exemplary embodiment of the invention, the method
further comprises maintaining an ambient pressure of the liquid in
the colon segment during the inserting and the simultaneous
removing within at least one of an increase in the ambient pressure
of no more than 0.06 Bar and a decrease in the ambient pressure of
no more than 0.20 Bar.
[0048] In an exemplary embodiment of the invention, agitating
comprises transmitting the agitation to a second segment of colon
adjacent to the colon segment. Alternatively or additionally,
agitating comprises rotating the mixture in the colon segment at a
rate of 10-100 RPM. Alternatively or additionally, agitating
comprises vibrating the mixture in the colon segment at a rate of
33-120 Hz. Alternatively or additionally, agitating comprises
alternatingly inserting a volume of a pressurized fluid into the
colon and a volume of a pressurized gas into the colon, the
pressure of the gas being at least 0.2 ATM above the pressure of
the liquid.
[0049] In an exemplary embodiment of the invention, inserting
additional liquid comprises inserting the liquid at a range of
between 400 cc/min and 2000 cc/min.
[0050] In an exemplary embodiment of the invention, the method
further comprises shredding of pieces of fecal matter to an average
size of less than 1 mm.
[0051] In an exemplary embodiment of the invention, the method
further comprises controlling at least one of the filling, the
agitating, the inserting and the emptying to clean the colon at a
rate of at least 10 cm/second.
[0052] In an exemplary embodiment of the invention, the method
further comprises controlling at least one of the filling, the
agitating, the inserting and the emptying to clean the colon at an
efficiency of at least 95%.
[0053] There is provided in accordance with an exemplary embodiment
of the invention a controller programmed to dynamically control
liquid input into a colon segment and material output from the
colon segment so as to maintain a mixture of liquid and feces at
least 60% full within the colon segment during changes in volume of
the colon segment.
[0054] There is provided in accordance with an exemplary embodiment
of the invention a device for cleaning a colon comprising:
[0055] a) a fluid input tube for supplying fluid to a colon segment
being cleaned, the tube extending from outside the colon to the
colon segment;
[0056] b) a material output tube through which liquid and fecal
matter may be removed, the tube extending from outside the colon to
the colon segment; and
[0057] c) an agitation element for transferring a sufficient amount
of energy to at least one of dislodge fecal matter from at least
50% of the surface area of walls of the segment and break-down at
least 50% of the volume of relatively large fecal matter blocks
inside the segment. Optionally, the agitation element is a helix.
Alternatively or additionally, the agitation element is a
paddle.
[0058] There is provided in accordance with an exemplary embodiment
of the invention a device for cleaning a colon comprising:
[0059] a) a material output tube through which liquid and fecal
matter may be removed, the tube extending from outside the colon to
the colon segment; and
[0060] b) a fluid flow pulsator which supplies alternating pulses
of pressurized liquid alternating with pressurized gas, wherein a
pressure of the gas is at least 0.2 atmospheres above a pressure of
the liquid, and a rate of input of the liquid into the colon
segment is at least 400 cc/min. Optionally, the pressure of the
liquid is substantially equal to an ambient pressure of a
liquid-fecal mixture inside the colon.
[0061] There is provided in accordance with an exemplary embodiment
of the invention a device for cleaning a colon comprising:
[0062] a) a fluid input tube for supplying fluid to a colon segment
being cleaned, the tube extending from outside the colon to the
colon segment;
[0063] b) a material output tube through which liquid and fecal
matter may be removed, the tube extending from outside the colon to
the colon segment; and
[0064] c) a filter covering the output tube, the filter having a
plurality of openings substantially parallel to a long axis of the
device, wherein a dimension of the openings substantially
perpendicular to the long axis is at least 3 mm.
[0065] There is provided in accordance with an exemplary embodiment
of the invention a colon-cleaning device at least 60 cm in length
and capable of cleaning a colon at a rate of 15 cm per minute
comprising
[0066] a. A liquid input tube configured to deliver at least 0.7
liters per minute into the colon at a distal end of the input
tube;
[0067] b. An output tube which encloses [0068] i. A mechanism for
reducing matter chunks entering the input tube to sizes of less
than 1.0 mm; and [0069] ii. A transport mechanism capable of
removing material from the colon to outside the body at a rate of
at least one liter per minute;
[0070] c. A controller programmed to control input flow and output
flow so as to establish and maintain a condition in which a colon
portion being cleaned is at least 60% filled with liquid.
[0071] There is provided in accordance with an exemplary embodiment
of the invention a device for continuously cleaning a colon
comprising:
[0072] a) a fluid input tube for supplying fluid to a colon segment
being cleaned, the tube extending from outside the colon to the
colon segment;
[0073] b) a material output tube through which liquid and fecal
matter may be removed, the tube extending from outside the colon to
the colon segment; and
[0074] c) a sensor configured to at least one of: determine
relative amounts of liquid and of gas present near a tip of the
cleaning device, measure input flow rates, measure output flow
rates; and
[0075] d) a controller configured to fiddle with at least one of an
input flow rate and an output flow rate to maintain a volume of a
segment of the colon to be mostly full of the fluid and feces.
[0076] 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0077] 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.
[0078] In the drawings:
[0079] FIGS. 1A-1D are simplified schematics of a colon cleaning
system;
[0080] FIGS. 2A-2J are simplified schematics of colon cleaning
systems agitating liquids in a filled colon, according to some
embodiments of the invention;
[0081] FIGS. 3A-3C are simplified schematics of colon cleaning
systems attachable to a colonoscope, according to some embodiments
of the invention;
[0082] FIGS. 3D-3E are simplified schematics of colon cleaning
systems with a filter, according to some embodiments of the
invention;
[0083] FIGS. 4A-4D and 4F are simplified schematics of features of
a colon cleaning system designed to induce a swirling motion in
liquids filling or partially filling a colon, according to some
embodiments of the invention;
[0084] FIG. 4E is a schematic of a simple nozzle system;
[0085] FIG. 5A is a simplified schematic of a colon cleaning system
comprising a water jet for cleaning the intake port of an
evacuation conduit, according to some embodiments of the
invention;
[0086] FIGS. 5B and 5C are simplified schematic of a colon cleaning
system comprising a camera, according to some embodiments of the
invention;
[0087] FIGS. 6A-6C are simplified schematics of a colon cleaning
system comprising turbines within an evacuation conduit, according
to some embodiments of the invention;
[0088] FIGS. 7A and 7C-7F are simplified schematics of systems for
alternatingly pulsing two types of fluids through a conduit,
according to some embodiments of the invention, and FIG. 7B is a
simplified schematic showing friction resistance to fluid flow
within a conduit;
[0089] FIG. 8 is a simplified schematic of a system for controlling
fluid input to a colon based on measurements of input and output
flows of the system, according to some embodiments of the
invention;
[0090] FIGS. 9A-9E are simplified schematics of a colon cleansing
system utilizing sensors to control fluid input into the colon,
according to some embodiments of the invention;
[0091] FIG. 10 is an exemplary control system for cleaning the
colon, in accordance with an exemplary embodiment of the
invention;
[0092] FIG. 11 is a flowchart of a method of cleaning the colon, in
accordance with an exemplary embodiment of the invention;
[0093] FIGS. 12A-12F present cleaning devices each having a
multi-lobe exhaust lumen which comprises a plurality of co-aligned
(substantially parallel) lobes running the length of the lumen,
according to some embodiments of the invention; and
[0094] FIGS. 12G-12I present cleaning devices using multiple fluid
input pipes and/or flattened exhaust lumens to reduce a
cross-sectional area of the devices, according to some embodiments
of the invention.
DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION
[0095] The present invention, in some embodiments thereof, relates
to devices and methods for cleaning body cavities and, more
particularly, but not exclusively, to devices and methods for
cleaning a colon.
[0096] An exemplary embodiment of the invention comprises filling
or partially filling a section of colon or other body lumen with a
fluid and/or liquid optionally comprising of gas, and agitating the
fluid. The agitation transfers a sufficient amount of energy to
dislodge fecal matter from the intestinal walls and/or to dismantle
relatively large fecal matter blocks into relatively smaller parts.
The dislodged and partially dissolved fecal matter can then be
removed from the intestine, cleaning the colon segment.
[0097] An exemplary embodiment of the invention, comprises mixing
at least one liquid with at least one type of gas (e.g. air) in
proportions of as much as 50% gas, 60% gas, 70% gas, 80% gas, or
other smaller, intermediate or larger percentages, and agitating
the liquid and/or gas to such an extent that the liquid and/or gas
interact with matter in the intestine as if a single turbulent
fluid.
[0098] In an exemplary embodiment of the invention, energy is
transferred to liquid filling or partially filling a colon by use
of an agitating device, such as a rotating device (helical device,
turbine, paddle, other), optionally within a tube filled with
liquid communicating with liquid outside the tube and/or by use of
a plurality of liquid jets (e.g., water) angled to create
rotational motion in surrounding liquid. For example, the liquid
inside the colon is agitated by causing the liquid to rotate at
about 10 RPM, about 20 RPM, about 60 RPM, about 100 RPM, or other
smaller, intermediate or larger rates of rotation are used. For
example, the liquid is agitated by applying energy in the form of
vibration induced in the liquid, such as vibrations between 33-120
Hz, or other smaller, intermediate or larger ranges are used. For
example, vibrations in the liquid substantially along a long axis
or omni-directional vibrations are between 0.5-20 Hz, or 5-10 Hz,
or other smaller, intermediate or larger ranges of vibration are
used. In some embodiments, an amount of energy sufficient to
agitate the fluid and/or feces in an omni-directional manner is
applied.
[0099] In an exemplary embodiment of the invention, the liquid
inside the colon is agitated (e.g., energy is transferred to the
liquid) using pulsed sequences, wherein liquid segments alternating
with gas segments within a fluid delivery tube, are inserted into
the colon. Alternatively or additionally, liquid is mixed with gas.
For example, fluids (e.g., water) and/or gas (e.g., room air) are
inserted at a rate of about 400 cc/min, about 700 cc/min, about
1000 cc/min, about 1500 cc/min, about 2000 cc/min, or other
smaller, intermediate or larger rates are used. In some
embodiments, the flow rate of gas is relatively larger than the
flow rate of liquid, for example, 700 cc of water cyclically
alternating with 1000 cc of air. This arrangement may provide high
speed pulsed liquid segments without requiring high input pressure,
and/or also may provide omni-directional shock waves when used
within a standing liquid.
[0100] In an exemplary embodiment of the invention, measurements of
fluid input to the colon and/or measurement of fluid and solid
output from the colon are compared to determine what quantity of
fluid is present in the colon. Optionally, this information is used
to maintain fluid input and/or output within safe proportions. For
example, fluids and/or solids are removed from the colon at a rate
of about 300 cc/min, about 1000/min, about 2000 cc/min, or other
smaller, intermediate or larger rates are used.
[0101] In an exemplary embodiment of the invention, a sensor is
used to determine relative amounts of liquid and of gas present
near the inlet and/or outlet of the cleaning device. Optionally,
data from the sensor is used to control fluid input and/or output
to/from the device.
[0102] In an exemplary embodiment of the invention, a pressure
inside the colon is maintained within a range, for example, 0-76
mbar, 5-50 mbar, 10-60 mbar, 25-60 mbar, 30-76 mbar, or other
smaller, intermediate or larger ranges are used. Optionally,
significant changes in the ambient pressure are detected and/or
prevented, for example a decrease in pressure of up to 0.20 Bar or
an increase in pressure of up to 0.06 Bar, or other smaller,
intermediate or larger values are used. Optionally, the pressure
rate and/or pressure change is maintained in the colon during
cleaning, for example, during fluid input, fluid output and/or
agitation of the fluid.
[0103] In some embodiments of the invention, a cross sectional
profile of a cleaning device is reduced by having a flattened
and/or crescent shaped lumen (e.g., evacuation lumen). Optionally,
matter evacuation elements inside the lumen (e.g., rotating
elements) are prevented from flailing and/or migrating by shoulder
like indentations of the lumen wall.
[0104] In an exemplary embodiment of the invention, a filter
prevents and/or reduces the risk of pieces of matter (e.g., feces)
from blocking an outlet (e.g., tube used to remove feces) of the
cleaning device. The openings in the filter have a dimension
sufficiently smaller than the openings of the outlet of the
cleaning device, for example, about 1 mm smaller, about 2 mm
smaller, about 3 mm smaller, or other smaller, intermediate or
larger sizes are used. The filter selectively admits fecal matter
through, depending on size. Relatively large pieces of feces are
prevented from entering and obstructing the outlet. Relatively
smaller pieces of fecal matter can pass through, the pieces being
sufficiently small not to obstruct the outlet. In an exemplary
embodiment of the invention, the filter is comprised of bars and/or
a mesh. In an exemplary embodiment of the invention, the filter
comprises enough openings to maintain flow into the outlet during
cleaning even if some of the openings become clogged with feces,
for example, at least 2, at least 4, at least 6 openings, or other
smaller, intermediate or larger number of openings are used.
Optionally, the filter prevents and/or reduces contact between the
colon wall and a rotating apparatus inside the outlet.
[0105] An aspect of some embodiments of the invention relates to
controlling and/or adjusting colon cleaning parameters to achieve
cleaning targets. In an exemplary embodiment of the invention,
colon cleaning parameters are set and/or adjusted according to
monitoring and/or feedback about the cleaning targets.
Alternatively or additionally, cleaning parameters are based on a
cleaning parameter table, such as having correlation data obtained
by trial and error. One or more non-limiting examples of cleaning
targets include: the rate of cleaning, the efficiency of cleaning.
In some embodiments, one parameter is adjusted in order to affect a
second parameter. One or more examples of indirect adjustment of
parameters include; controlling the agitation of fluid and/or the
proportion of fluid in the colon to control the cleaning rate
and/or efficiency.
[0106] In an exemplary embodiment of the invention, methods and/or
devices are provided for filling a section of colon with a fluid,
to reach a fecal-fluid mixture that mostly fills a volume of the
segment of the colon. The remainder of the volume in the segment of
the colon (non fluid-fecal) is comprised of a gas, such as room air
and/or CO.sub.2. Non-limiting examples of the absolute volume of
the colon segment include about 50 milliliters, about 150 mL, about
250 mL, about 500 mL, about 1 liter, about 2 liters, or other
smaller, intermediate or larger volumes are used. Non-limiting
examples of the absolute volume of the fecal-fluid mixture include
about 50 milliliters, about 150 mL, about 250 mL, about 500 mL,
about 1 liter, about 2 liters, or other smaller, intermediate or
larger volumes are used. Non-limiting examples of the ratio of the
fecal-fluid mixture to the volume of the segment include at least
50%, at least 60%, at least 70%, at least 80%, at least 90%, about
100% of the volume of the segment of the colon, or other smaller,
or intermediate values are used.
[0107] In some embodiments, the section of colon is selected
according to a length of the segment. For example, about 5 cm,
about 10 cm, about 30 cm, about 50 cm, or other smaller,
intermediate or larger lengths are used. Optionally, the segment of
colon is manually selected by a user, such as by the physician, for
example, the segment the physician is visually inspecting during a
colonoscopy procedure. Alternatively or additionally, the segment
of colon is related to the cleaning ability of the cleaning device,
for example, the largest volume of the colon and/or the furthest
distance that the cleaning device is able to clean from feces.
Alternatively or additionally, the section of colon is related to
the anatomy of the patient, for example, the tortuous nature of the
colon naturally separates segments from one another.
[0108] In an exemplary embodiment of the invention, the segment is
filled to be mostly full of the fluid-fecal matter mixtures,
without mostly filling other segments and/or parts of the colon.
For example, the filled segment is relatively lower than other
nearby segments, and is filled by gravity. The patient can be moved
and/or positioned to aid in placing the colon segment to be filled
relatively lower than other nearby segments. Alternatively, other
segments are also filled, for example, the entire colon or portions
thereof are filled.
[0109] In some embodiments, the mixture mostly comprises of fecal
matter, for example, if the colon is about 90% full of relatively
dry fecal matter, the added fluid will mostly enter air spaces
inside the feces, maintaining the fecal-fluid mixture ratio at
about 90% of the volume of the segment of the colon.
[0110] In an exemplary embodiment of the invention, the volume of
the colon segment is estimated and/or determined according to the
dimensions of the colon during cleaning. The walls of the colon are
relatively flexible and relatively elastic, allowing for a range of
shapes and/or sizes. In some cases, the colon segment is mostly
collapsed (e.g., if relatively empty) around any feces and/or
liquid inside the segment. In such a case, the amount of the feces
and/or fecal-fluid mixture is about 100% of the total volume of the
colon segment. In some cases, the colon segment is partially and/or
completely inflated (without stretching the walls), such as by
filling the segment with CO.sub.2 gas during a colonoscopy and/or
the feces in the colon inflate the colon. In some cases, the colon
segment is over-extended (e.g., an increase in diameter of the
colon of over 100% as compared to the inflated state), such as by
overfilling with gas and/or with fluid causing the colon walls to
stretch. In an exemplary embodiment of the invention, the percent
of the fecal-fluid mixture out of the total volume of the colon is
dynamically determined according to changes in the dimensions of
the colon.
[0111] In an exemplary embodiment of the invention, appropriate
liquids include water or other liquids and may comprise
supplemental additives such as drugs, osmotic solution, PEG based
solution, or any other mixture of agents used in the medical field.
Optionally, the supplemental additives aid in cleaning the colon,
non-limiting examples include detergents, foam formers and/or
wetting agents.
[0112] In an exemplary embodiment of the invention, the fluid-fecal
mixture is agitated; energy is applied to the fecal-fluid mixture,
such as by rotating, swirling, vibration, shaking, pressure waves
and/or other types of motion imparted to the mixture of fluid-feces
filling or partially filling the intestine. Optionally, energy is
transmitted to the mixture through a non-fecal liquid (e.g.,
water), such as located between the device and feces. A
non-limiting hypothesis is that the amount of energy transferred to
the mixture is sufficient to cause an agitation of the mixture,
wherein the fecal matter becomes detached from the intestinal walls
and/or generally causes larger chunks of matter to break down into
smaller elements. The fecal matter is then easily removed from the
intestine using a suction device or any other device for
transporting fecal matter out of the body.
[0113] In an exemplary embodiment of the invention, the energy
transmitted to the mixture causes agitation of the mixture
relatively in front of the cleaning device (e.g., the device inlet
and/or outlet), for example, at least 2 cm distally, at least 5 cm,
at least 10 cm, at least 15 cm, at least 20 cm, at least 30 cm, at
least 50 cm, or other smaller, intermediate or larger values are
used. Alternatively or additionally, the mixture relatively behind
the cleaning inlet and/or outlet is agitated. Alternatively or
additionally, the mixture surrounding the cleaning device is
agitated. Optionally, the agitated mixture is removed. In some
embodiments, fecal matter surrounding at least a part of the
circumference and/or surface area of the colon segment is agitated,
even if the colon is not full of feces, for example at least 20% of
the circumference and/or surface area, at least 50%, at least 80%,
about 100%, or other smaller or intermediate percentages are used.
In some embodiments, fecal matter inside the volume of the colon
segment is agitated (e.g., broken down into relatively smaller
pieces), for example, at least 50% of the volume at least 80% of
the volume, about 100% of the volume, or smaller, intermediate or
larger percentages are used. For example, the agitation is
sufficiently strong, to cause rotational motion of the mixture,
thereby cleaning the entire circumference. Alternatively, a section
of the circumference is cleaned.
[0114] In an exemplary embodiment of the invention, agitation is
transmitted to the mixture from inside the cleaning device, for
example by a rotational device inside the cleaning device,
transmitting energy to a fluid inside the cleaning device, the
fluid hydraulically transmitting the energy to feces. Alternatively
or additionally, agitation is transmitted to the mixture directly,
for example, by a rotational device outside the cleaning device,
for example, transmitting energy directly to the feces.
[0115] In an exemplary embodiment of the invention, one or more
non-limiting examples of devices used to cause agitation include;
the rotational devices such as a screw and/or spring, a paddle, a
brush, an element that vibrates, pointed fluid outlet jets,
alternating pulses of pressurized fluid and pressurized gas. Two or
more devices may be used sequentially and/or in combination, for
example, a rotating screw may be used to achieve agitation inside
the outlet of the device and alternating pulses may be used to
achieve agitation near the inlet of the device (e.g., source of
fluid provided by device into colon segment).
[0116] In an exemplary embodiment of the invention, flow and/or
motion of the fluid-fecal mixture due to agitation is directed
towards the device, such as to suck the mixture into the device
outlet. Alternatively or additionally, flow and/or motion of the
mixture due to agitation is directed not towards the device, for
example, as random motion and/or motion away from the device inlet,
such as to remove feces from the colon wall and/or to break down
the feces. Non-limiting examples of motion include a relatively
violent spinning rotational motion, a gentle flow into the cleaning
device, forward/backward vibrational motion and/or motion caused by
explosive-like forces.
[0117] In an exemplary embodiment of the invention, systems
maintain a predetermined level of fluid fill (i.e. filling a
segment of colon with liquid to a predetermined level or percentage
of a fluid-fecal mixture inside the volume of the colon segment),
for example, about 20%-100% full, about 60%-100% full, about
60%-90% full, about 80-95% full, or other smaller, intermediate or
larger ranges are used. Optionally, the GI physician/operator will
determine what degree of fill and what pressures are appropriate
for a given patient. In many cases filling the colon nearly full of
water will be most effective, but on some cases merely filling the
segment to at least 20%, at least 30%, at least 40%, or other
smaller, intermediate or larger filling values, and/or covering the
outlet (e.g., outlet tube for feces and/or fluid) of the apparatus
with water could be quite effective.
[0118] In an exemplary embodiment of the invention, the degree of
fill is maintained during dynamic changes in the dimensions of the
colon (e.g., using a controller). For example, if the physician
selects the volume of the segment to be maintained at least at 90%,
additional liquid will be inserted to keep the volume at least at
90% if the cross sectional size of the colon increases such as by
the addition of CO.sub.2 gas, or by the addition of the liquid
itself. Alternatively, the cross sectional area of the colon may
decrease, such as during removal of feces, in which case to
maintain the 90% volume excess liquid can be removed. In an
exemplary embodiment of the invention, the pressure is controlled
at the same time as the degree of fill, for example, to prevent
and/or reduce adverse events such as over-expanding the colon
and/or sucking the colon wall tissue into the outlet tip of the
device.
[0119] In an exemplary embodiment of the invention, the degree of
fill is maintained while the device is working and/or cleaning.
Optionally, the degree of fill is maintained during the fluid
exchange inside the colon segment (e.g., inserting and/or removing
fluid). Alternatively or additionally, the degree of fill is
maintained during the agitation of the fluid. Alternatively or
additionally, the degree of fill is maintained while maintaining
pressure within the range.
OVERVIEW AND POTENTIAL ADVANTAGES
[0120] Colonoscopies (viewing the inside of the colon using an
endoscopic device with the ability to perform medical procedures
therein) are performed for a variety of clinical indications. Some
of the most common include screening colonoscopies such as to
search for early stages of colon cancer, and emergency
colonoscopies, such as to search for a source of a lower
gastrointestinal bleed.
[0121] In the case of a screening colonoscopy (e.g., performed
every 5-10 years), a patient's colon is cleansed by having the
patient drink relatively large volumes of a liquid that stimulates
massive bowel movements. The procedure is generally unpleasant for
patients and can take a relatively long time to complete.
Furthermore, the patient's colon may not be entirely cleaned of
feces, disturbing the ability of the physician to scan the internal
bowel wall for cancer and to remove polyps.
[0122] The application describes herein an apparatus and a method
for the cleaning of a colon. Some non-limiting potential advantages
(embodiments do not need to meet some or even all of the potential
advantages) include; relatively reduced procedure times (e.g.,.
relatively reduced cleaning times), relatively improved procedure
safety, ability to clean an unprepared or partially prepared colon,
and/or ability to clean during a colonoscopy. For example, in the
case of emergency colonoscopies, the time to prepare the patient
may be very limited. A colon relatively full of feces causes
difficulty for the physician to operate, such as to visualize and
stop a source of bleeding.
[0123] For purposes of better understanding some embodiments of the
present invention, as illustrated beginning with FIG. 2A of the
drawings, reference is first made to the construction and operation
of an intestinal cleaning device as illustrated by FIGS. 1A-1D.
[0124] FIG. 1A shows a section of colon with colon wall marked
"LU", and within that colon section a standard colonoscope 500.
Colonoscope 500 comprises a camera 504, a fluid input conduit (not
shown) terminating in nozzles 501, a working channel 502 typically
used to remove fluids and solid matter out of the body using
suction or alternatively used to insert surgical tools into the
colon, and a steering segment 503 adjustable by manipulating knobs
on a proximal portion of the colonoscope, which knobs enable a user
to steer the colonoscope's tip within the colon. When colonoscope
500 is used in complementary colon cleaning, water under pressure
is provided in the fluid input conduit and caused to issue from
nozzles 501 as pressurized jets of water. When the physician or
other operator observes a portion of fecal matter (marked FE1 and
FE2 in the drawing) adhering to the intestinal wall, he turns the
proximal knobs to bend steering section 503 in a way that aims the
colonoscope tip towards that matter. He then provides a jet of
water from nozzles 501 towards the observed fecal matter, thereby
dislodging it from the intestinal wall. As shown in FIG. 1B, the
dislodged fecal matter mixed with water from nozzles 501 then
typically drains downward under the influence of gravity and pools
in small puddles comprising water and fecal matter. Such a pool or
puddle is marked "PU" in FIG. 1C.
[0125] In an example of a cleaning procedure, the GI physician
individually aims the tip of the colonoscope at the various feces
deposits, washing them individually off the intestinal wall, then
stops the water jet, aims the distal end of colonoscope 500 towards
the pooled water and dislodged fecal matter (PU), and uses suction
provided in output conduit 502 to suck up and remove the pooled
water and feces. This process is shown in FIG. 1D. Typically, the
sequence of steering, cleaning with water jet, re-steering towards
the pooled matter, and suction, practiced repeatedly, in a cyclical
manner, each time handling a small concentration of fecal matter
individually identified and aimed at and cleaned, until eventually
the entire colon wall is clean.
[0126] As mentioned in the background section above, an example of
a cleaning device is provided by PCT application WO\2009\143201 by
Gordon. This device is also known in commerce as "Easy-Glide", and
differs from the above description in that the "Easy-Glide" device
is external to the endoscope, provides an input water conduit and
output feces-transporting conduit, and therefore leaves the
colonoscope's working channel free for other uses. Use of the
"Easy-Glide" device, however, is similar to the procedure described
above: the GI physician has to steer the colonoscope tip towards
each concentration of fecal matter and again towards the pooled
fecal matter after this has been washed off the intestine wall by a
water jet, and the process must be repeated over and over in order
to obtain a clean colon wall.
[0127] Before explaining at least one embodiment of the invention
in detail, it is to be understood that the invention is not
necessarily limited in its application to the details of
construction and the arrangement of the components and/or methods
set forth in the following description and/or illustrated in the
drawings. The invention is capable of other embodiments or of being
practiced or carried out in various ways. In particular, although
descriptions of embodiments presented below refer to the colon and
to cleaning of the colon, it is to be understood that the invention
is not limited to that context and can be used for cleaning other
body lumens, for example, the upper gastrointestinal track and/or
stomach. It is further noted that embodiments presented below as
features of an endoscope or colonoscope can also be practice in a
stand-alone system sans endoscope, or in an add-on system attached
to an endoscope and/or used together with an endoscope, and
conversely that embodiments presented in stand-alone or add-on
format can also be incorporated in an endoscope or colonoscope.
[0128] In an exemplary embodiment of the invention, the cleaning
device is designed to clean feces from the colon. Non-limiting
examples of `cleaning feces` include; cleaning a relatively large
amount of feces (for example, at least 500 cc, at least 1000 cc, at
least 2000 cc, or other smaller, intermediate or larger volumes of
feces), cleaning relatively dry, relatively hard and/or relatively
large feces (e.g., feces requiring the addition of sufficiency
fluid and/or energy imparted to the feces to break apart and/or
move the feces).
[0129] Throughout this application, various embodiments of this
invention may be presented in 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.
Clinical Scenarios
[0130] In an exemplary embodiment of the invention, the cleaning
device can be used to clean colons in a variety of clinical
scenarios. Optionally, at least some of the cleaning parameters
(e.g., input/output fluid rates, liquid rotation rate, cleaning
rate, cleaning efficiency, working pressure) are selected according
to the clinical scenario, for example, according to a table of
correlation values, for example, as described with reference to the
section "Exemplary Control System". Alternatively or additionally
at least some of the cleaning parameters are not dependent on the
clinical scenario.
[0131] In an exemplary embodiment of the invention, the cleaning
device is used as an add-on to an endoscope (e.g., colonoscope),
for example, to clean before and/or during a procedure.
Alternatively or additionally, the cleaning device is used alone,
for example, to clean the colon if a procedure is not being
performed.
[0132] One or more non-limiting examples of clinical scenarios
include: [0133] An `unprepared` colon, for example, of a patient
requiring an emergency colonoscopy. [0134] An `overfilled colon`,
for example, of a patient with chronic constipation (e.g., cancer
patient with abdominal metastases) requiring occasional cleaning.
In some embodiments of the invention, cleaning is performed alone,
such as unrelated to a colonoscopy procedure. [0135] Cleaning for
`well being`, for example, as a preventive measure in certain
patient populations, such as frail elderly patients living alone.
[0136] A `semi-prepared` colon, wherein the partial preparation was
intended, for example, to perform a colonoscopy in a patient that
would be unable to tolerate a full cleaning preparation, such as
the elderly. [0137] A `semi-prepared` colon, wherein the partial
preparation was unintentional, for example, a patient that did not
understand how to follow the preparation instructions.
[0138] Some potential advantages of using the apparatus and/or
method as describe herein, such as during one or more of the
scenarios described include; relatively reduced procedure times,
relatively improved procedure safety, ability to clean an
unprepared or partially prepared colon, and/or ability to clean
during a colonoscopy.
Filling the Colon with Liquid, Swirling the Liquid
[0139] Attention is now drawn to FIG. 2A and the following figures,
which present various exemplary embodiments. Some embodiments are
distinguished in that they are designed to be applied in a colon or
other conduit which is largely or completely filled with fluid,
typically a mixture of water, air, and dislodged fecal matter. In
some embodiments the method comprises practicing a cleaning
function in a colon substantially full of fluid in which water or
other liquids predominate and represent more than 30% by volume,
and in some cases more than 60% by volume. Using these devices and
methods, superior cleansing results can be obtained, and the
process is relatively faster and more efficient because there is
typically little or no need to steer the endoscope tip specifically
toward individual deposits of fecal matter. In some embodiments,
water-jet cleaning and exhaust suction can be practiced
simultaneously.
[0140] It is to be noted that in the following, various features
and embodiments are presented in isolation for simplicity of
exposition, but it is to be understood that embodiments presented
herein can be used in a variety of combinations, and that the
present disclosure should be understood to include all such
combinations of embodiments and/or features.
[0141] Referring again to the drawings, FIGS. 2A-2J present
embodiments of methods and devices for cleaning a body lumen and/or
conduit, for example, a colon, such as a segment of the colon
(e.g., ascending, descending, transverse portions or partial
segments thereof), referred to in the following as colon cleaner
510A.
[0142] FIG. 2A shows a portion of a colon (marked "LU") into which
cleaner 510A has been introduced. Cleaner 510A comprises at least
one fluid input conduit 511A optionally terminating in a nozzle
511B. Cleaner 510A also comprises an output conduit 512 used to
evacuate fluids & fecal matter from the body. Conduit 512
houses a rotating apparatus 517, such as helical apparatus 513
shown in the figure. Rotating apparatus 517 may be powered by an
external motor connected at its proximal end (not shown in the
figure). Helical apparatus 513 is designed to rotate on its axis
within conduit 512, and serves to transport fluid and fecal matter
through conduit 512 and out from the body. Optionally, helical
apparatus 513 may be implemented in the form of threads of a screw
rather than a helical `spring` format, or as a helically formed
spiral brush, or as one helical spring turning freely within a
second helical spring, or in any other format which will impart
motion in a proximal direction (i.e. out of the body) to fluids and
fecal matter within conduit 512. Optionally, conduit 512 may also
be used to inject fluid into the colon or other body lumen being
cleaned, the process of injecting fluid and the process of
evacuating fluid alternating with one another in a cyclical
manner.
[0143] FIGS. 2A-2F illustrates a process. FIGS. 2A and 2B represent
a "before" picture wherein fecal matter (FE) covers the colon wall
(LU). The GI physician can use cleaner 510A without needing to
steer it towards fecal concentrations. Optionally, the inlet and/or
outlet of cleaner 510A are placed at non-specific locations within
the colon segment. Optionally, cleaner 510A is steered (e.g., moved
by a physician) within the colon segment to the non-specific
location, for example, to relatively improve cleaning performance.
The non-specific location can achieve the required colon cleaning
effect, such as by allowing sufficient agitation to be provided to
the liquid in the colon as described herein, for example, by
allowing omni-directional agitation. Placing cleaner 510 at certain
positions can relatively increase the cleaning performance, for
example, cleaner 510A may be left to "float" in the colon lumen
without any pre-set direction. A potential advantage of cleaning by
placing and/or steering cleaner 510A to the non-specific location
is relatively improved and/or easier colon cleaning procedures. For
example, the physician does not need to steer the cleaner to
individual fecal deposit, a relatively time consuming procedure.
FIGS. 2C and 2D show fluid, primarily a liquid such as water or
water mixed with other substances, being introduced through conduit
511A/B and optionally also through conduit 512. (Note: in some
embodiments, conduit 511A/B may be absent, conduit 512 serving both
as input conduit and as output conduit.)
[0144] The label PU marks the `water level` to which the colon is
being filled in the exemplary embodiment shown in these figures.
When the colon is filled to the PU level, or optionally while
filling of the colon is still taking place, the physician operator
may turn on the external motor (not shown) which powers rotation of
helical apparatus 513. This situation is shown in FIGS. 2E-2F.
[0145] Rotation of helical apparatus 513, which may be a helix in
`coiled-spring` form, or a screw-thread configuration, or any
similar structure may produce fluid flow in a proximal direction in
conduit 512. The fluid flow may result in evacuation of fluid and
fecal matter through conduit 512 and out of the body. In some
embodiments element 513 is formed as a helix. Rotating the helix in
an appropriate direction can move fluid and solids along conduit
512 in a direction which carries them out of the body. Optionally,
use of a helix in this context also contributes by shredding pieces
of fecal matter which might otherwise block conduit 512. Element
513 therefore can serve to keep conduit 512 open at all times.
Element 513 can provide a safety feature preventing over-pressuring
the colon, which could otherwise present a surgical risk.
[0146] In addition, helical apparatus 513 or any other rotating
apparatus 517 (for example, paddles presented in FIGS. 2G-2J and
turbines presented in FIGS. 6A-6C, both discussed below) can
produce the following two effects:
[0147] (a) Inducing generalized movement in fluids outside conduit
512, which can produce an enhanced cleansing effect. Rotation of
rotating apparatus 517 within evacuation conduit 512 can generate a
rotational movement of fluids within conduit 512. In some
embodiments, these fluids are continuous with fluids outside
conduit 512 and within the colon lumen. Rotation of fluids within
conduit 512 can induce rotation of the fluids within filled segment
514 of the colon lumen. Such induced rotation of fluids within the
body lumen is referred to herein as a "projection effect".
[0148] In an exemplary embodiment of the invention, the rate of
rotation of fluid within filled segment 514 is substantially less
than the rate of rotation of rotating apparatus 517, such as due to
frictional forces. For example, apparatus 517 rotates at about
2000-7000 RPM translates into about 10-400 RPM rotation of liquid
in filled segment 514.
[0149] (b) Vibration: rotation of rotating apparatus 517 within
conduit 512 may generate vibration. In some embodiments rotating
apparatus 517 may be weighted asymmetrically, (e.g. a weight may be
added asymmetrically to one side of a helix, so as to enhance
generation of such vibrations). When cleaner 510A is used in a
liquid-filled colon as taught above, vibrations generated by
rotating apparatus 517 can transmitted very efficiently to the
surrounding liquid. Such vibration can be effective in breaking
down clumps of fecal matter into small parts, and/or having the
effect of helping to "peel" fecal matter from the colon wall.
[0150] In some embodiments, the vibrations are transmitted to one
or more adjacent segments of the colon through the colon wall and
connecting tissues, for example, in a tortuous colon. The
transmitted vibrations can dislodge and/or break down feces in the
adjacent segments, potentially resulting in relatively improved
cleaning times and/or cleaning efficiency.
[0151] In an exemplary embodiment of the invention, vibrations
occur in at least one plane. Optionally, vibrations occur
substantially along the longitudinal axis, for example `front` and
`back` vibrations. Alternatively or additionally, vibrations are
omni-directional. Longitudinal vibrations may occur as a result of
mismatches of movement between rotating apparatus 517 and conduit
512 (e.g., due to differences in lengths and/or diameters). In some
embodiments, vibrations occur intentionally (e.g., by a controller
and/or user). Alternatively or additionally, vibrations that occur
unintentionally such as by movement of the motor and/or during use
of the cleaning device are used in combination with controlled
vibrations to achieve a desired set of vibrations.
[0152] In an exemplary embodiment of the invention, agitation such
as vibration of the fluid inside the colon segment is created using
at least one element and/or using a combination of elements,
non-limiting examples of elements include; the fluid inlet, the
fluid outlet, and/or a separate tube, each of the elements
optionally comprises an agitation element (e.g., the rotating
spring) to agitate and/or vibrate the fluid.
[0153] The effects listed above which can result from rotation of
helical apparatus 513 and/or any other rotational apparatus 517
within conduit 512, (evacuation of materials, induced rotation of
liquids, and transmitted vibration), individually and in
combination can produce a cleansing effect within the colon or
other body lumen.
[0154] In some embodiments, additional elements and/or alternative
elements may be added to, or substituted for, helical element 513,
for example to agitate fluids within the colon and outside conduit
512. FIGS. 2G and 2H show a rotational element 517 which is a flat
paddle 515 within conduit 512 at the distal end of a connecting
flexible rod or shaft 516, with shaft 516 connected either to a
helical apparatus 513 or directly to a proximal motor operable to
rotate paddle 515. FIGS. 2I and 2J, where paddle 515 is embodied as
a multi-bladed paddle. An exemplary embodiment of a multi-bladed
paddle is shown, with four blades provided in an `X` format, the
blades marked 515A and 515B on the Figure.
[0155] It is to be noted that paddles 515 are exemplary
implementations, and not limiting. Any form of paddle (including
irregular shaped paddles, paddles with holes, a rotary array of
fins) may be used, and non-paddle element may be used. In some
embodiments, a turbine arrangement (fins turning within an
enclosure) may be used, as shown in FIGS. 6A-6C. In general,
element 517 is any element which imparts a rotary motion to fluid
within conduit 512, that motion being of sufficient strength to
propagate outside of conduit 512 and impart rotary or turbulent
motion to fluids outside conduit 512, such that those movements
propagate within the colon and serve to loosen and detach fecal
matter from the colon walls.
[0156] In some embodiments elements 513 and 515 are contained
within conduit 512. This can prevent the colon wall from direct
contact with these rotating elements, which might otherwise damage
the wall.
[0157] In an exemplary embodiment of the invention, a colon section
is filled or partially filled with liquid, then motion is induced
in the liquid and the section is cleaned and evacuated by suction.
Optionally, filling, motion inducing, and cleaning and evacuation
are practiced simultaneously in a continuous process, while the
cleaning device is (optionally) advanced the length of the colon.
Required liquid levels in a colon section being cleaned can be
maintained by operator control or can be maintained automatically
as explained below.
Method of Cleaning the Colon
[0158] FIG. 11 is a flowchart of a method of cleaning the colon, in
accordance with an exemplary embodiment of the invention. In an
exemplary embodiment of the invention, at least some of the method
of cleaning is under automatic control, for example by controller
1002 as described with reference to the section "Exemplary Control
System". Alternatively or additionally, at least some of the method
is under manual control, such as by the physician performing the
procedure.
[0159] Optionally, at 1102, a colon cleaner (e.g., cleaner 510A) is
advanced inside the colon, for example, as illustrated with
reference to FIG. 2A, in accordance with an exemplary embodiment of
the invention. Alternatively, the colon cleaner is introduced
inside the colon but kept at a constant position. Non-limiting
examples of advancing the colon cleaner include advancing an
endoscope having the device coupled thereto, advancing the device
independently (e.g., manually such as by a physician pushing
device, automatically such as by device self propelling and/or
`walking`), advancing the device over a guidewire.
[0160] At 1104, fluid is introduced into the colon, in accordance
with an exemplary embodiment of the invention. For example, as
described in the section "Filling the colon with liquid, swirling
the liquid".
[0161] Optionally, at 1106, the proportion of fluid in the colon
(e.g., colon segment) is measured and/or estimated, in accordance
with an exemplary embodiment of the invention. For example, as
described with reference to the section "Systems for maintaining
colon fill levels: Measuring water levels". In an exemplary
embodiment of the invention, the submergement of the colon cleaner
in the fluid is detected.
[0162] At 1108, the fluid (e.g., introduced liquid and feces)
inside the colon (e.g., colon segment) is agitated such as by
vibration, water jets, rotational motion and/or shock waves, in
accordance with an exemplary embodiment of the invention. For
example, as described with reference to the sections "Filling the
colon with liquid, swirling the liquid", "Swirling liquid motion
produced by circularly directed water jets" and/or "Pulsing
systems".
[0163] At 1110, fluid and/or waste is removed from the colon, in
accordance with an exemplary embodiment of the invention. For
example, as described with reference to the sections "Filling the
colon with liquid, swirling the liquid", "Cleaning systems with
turbines" and/or "Backward-pointing water jet". Optionally, the
waste is shredded during removal.
[0164] Optionally, at 1112, the process is monitored, for example,
the pressure inside the colon is measured and/or estimated (e.g.,
by a sensor), in accordance with an exemplary embodiment of the
invention. For example, monitoring occurs as described with
reference to the sections "Systems for maintaining colon fill
levels: Measuring input/output" and/or "Systems for maintaining
colon fill levels: Measure water levels".
[0165] Optionally, at 1114, adjustments are made to the process, in
accordance with an exemplary embodiment of the invention. For
example, based on monitoring as in 1112 and/or based on the
proportion of fluid as in 1106, the input and/or output fluid rates
can be suitably adjusted up or down to achieve targets such as the
proportion of fluid in the colon as in 1106 and/or to control the
pressure inside the colon.
[0166] Optionally, at 1116, the process is repeated, with optional
adjustments as determined in 1114.
[0167] In some embodiments of the invention, at least some of the
process occurs substantially in parallel, for example, at least
some of advancement as in 1102, fluid insertion as in 1104, fluid
agitation as in 1108 and/or fluid removal as in 1110.
Alternatively, at least some of the process occurs in a step-wise
manner. Optionally, measuring as in 1106, monitoring as in 1112
and/or adjustments as in 1114 occur substantially in parallel
and/or during specified times and/or after specified actions.
Cleaning Module Attachment to Colonoscope
[0168] Attention is now drawn to FIGS. 3A and 3B, which show
embodiments wherein an independent cleaning module 520,
substantially as described above, is presented for use with (and
optionally connected to) an endoscope or colonoscope 530, which can
be a standard colonoscope. Optionally, cleaning module 520 is an
external add-on attachment to colonoscope 530. In FIG. 3A the main
body of cleaner 520 is positioned somewhat proximally to a distal
end of endoscope 530, and a fluid input conduit 522, is advanced to
a distal end of colonoscope 530, where it is attached by attachment
band 521. An advantage of the construction shown in FIG. 3A is that
cleaning device 520, which is likely to be somewhat stiff in
construction because of the rotating mechanical devices it
contains, is positioned proximally with respect to the steering
mechanism 503 of endoscope 530. which is therefore able to be
steered and directed freely without the steering process being
influenced by the presence of cleaner 520. In an alternative
construction shown in FIG. 3B, distal ends of cleaning device 520
and colonoscope 530 are positioned substantially side by side. In
both cases, cleaning device 520 provides cleaning services,
potentially leaving the working channel of colonoscope 530
available for other surgical work. Round arrows labeled `SW` and
arrows pointing into outlet conduit 525 illustrate swirling and/or
agitation motion in the liquid in the colon, for example, induced
by a rotation element 526.
[0169] In some embodiments, a cleaning module (e.g., one or more of
the embodiments described herein, and/or any subcombinations
thereof) is designed to be entirely and/or partially inserted into
a working channel of a colonoscope (e.g., colonoscope 530), for
example, by designing relatively smaller components to fit inside
the working channel. Non-limiting examples of the size of the
working channel into which the components can fit include; less
than 2 mm in diameter, less than 3.5 mm in diameter, less than 5 mm
in diameter, or other smaller, intermediate or larger values are
used. Optionally, all of the elements comprising the cleaning
device (e.g., as described herein) are inserted into the working
channel of the colonoscope. Alternatively, some of the elements are
inserted inside the working channel, and some of the elements are
external. One or more non-limiting examples of elements include;
fluid supply pipe, fluid removal pipe, rotational element, grinding
element, fluid/gas pulsating system, and/or filter.
[0170] In an exemplary embodiment of the invention, the cleaning
module 520, optionally connected to the endoscope or colonoscope is
insertable relatively far into the colon (e.g., from the anal
sphincter), for example, at least 40 cm, at least 60 cm, at least
100 cm, at least 150 cm, at least 200 cm, or other smaller,
intermediate or larger distances.
Exemplary Embodiments for Graining and/or Exhausting Fecal
Matter
[0171] Attention is now drawn to FIGS. 12A-12F, which present some
embodiment of the invention which include features that facilitate
`graining` of fecal matter within an evacuation conduit of a
cleaning device. Optionally, `graining` is created by turbulence
within the conduit and/or by grinding and/or cutting the pieces
and/or by pulling the pieces apart by subjecting the pieces to
contradictory pulling forces.
[0172] FIGS. 12A-12F present some embodiments of cleaning devices
having a multi-lobe exhaust lumen, in accordance with some
embodiments of the invention. The lumen comprises a plurality of
co-aligned lobes running side by side along at least a portion of
the length of the lumen.
[0173] FIG. 12A shows a device 1200D comprising within a housing
1202 an (optional) endoscope optic 1204, one or more fluid input
conduits 1206, and a matter exhaust lumen 1208 shaped within
housing 1202 and which comprises a first lobe 1210 and a second
lobe 1212. Lobes 1210 and 1212 are in fluid communication along at
least a part of their length, which is to say that fluid and other
matter can flow between them. Each lobe has a central axis (shown
as a "+" in the figure) and optionally has a cross-section at least
part of which has a circular border, as shown in FIG. 12A. Lumen
1208 as a whole has a roughly "FIG. 8" shape, optionally providing
room for a fluid input lumen 1214 as shown in FIG. 12A.
[0174] FIG. 12B shows a cleaning device 1200E wherein a two-lobed
exhaust lumen 1216 contains a rotatable device in one or in both
lobes, in accordance with some embodiments of the invention. FIG.
12B shows a rotatable device 1218A in lobe 1210 and a rotatable
device 1218B in lobe 1212. It is to be understood however that
device 1200E may comprise one rotatable device or two.
[0175] Lobes 1210 and 1212 are open to each other, in the sense
that fluid communication between them is possible along at least a
portion of their length.
[0176] Lobes 1210 and 1212 are sized and shaped with respect to
helical devices 1218A and 1218B in such a way that devices 1218A
and 1218B are independently rotatable each within its lobe.
Optionally, devices 1218A/B are able to independently advance and
retract each within its lobe. In some embodiments, a `shoulder`
1220, or other similar formation, prevents devices 1218A and 1218B
from moving `sideways` from one lobe into another.
[0177] In some embodiments, devices 1218A and/or 1218B can be
rotated in the directions shown by the small arrows in FIG. 12B:
clockwise in lobe 1210 and/or counterclockwise in lobe 1212. In
some embodiments, both can be rotated in directions opposite to
those shown in the figure, i.e. counterclockwise in lobe 1210
and/or clockwise in lobe 1212. These directions cause portions of
devices 1218A and/or 1218B which approach each other within their
common lumen 1216 to approach a parallel movement where they are
closest together, and then to pull apart.
[0178] Alternatively, in some embodiments devices 1218A and 1218B
can be rotated in opposing directions (i.e. clockwise in both lobes
or counterclockwise in both lobes). The two devices 1218A and 1218B
can be moved in opposing directions where they are at their closest
approach. Additionally, in some embodiments one or both rotatable
devices can be caused to alternate rotational direction.
[0179] In some embodiments, devices 1218A and 1218B are helical
devices (also designated 1218A and 1218B. Optionally, if device
1200E is inserted in an intestine, rotation of a helical device in
one direction may serve to pull matter towards the intestine.
Optionally or additionally, rotation in the opposite direction can
serve to pull matter away from the intestine. Rotating one helical
device in a direction which pulls matter towards the intestine
and/or rotating the other in a direction which pulls matter away
from the intestine may create shearing forces which may contribute
to graining of matter caught between the helices.
[0180] In general, that diversity of movements described above
(pulling towards intestine or away, rotating to create parallel
movement or opposite movement, and independently moving helices or
other rotating devices forward and backward in their lumen) create
pulling, pushing and/or cutting forces which can serve to cut,
grind, and otherwise grain material within lumen 1216.
[0181] In an exemplary embodiment of the invention, the shredding
of pieces of fecal matter to a relatively small size is
controllable and/or settable, for example, to an average size of
less than 0.1 mm, less than 1 mm, less than 3 mm, less than 5 mm,
or other smaller, intermediate or larger average sizes are used.
Optionally, the matter crushing elements (e.g., devices 1218A
and/or 1218B) are selected to result in shredding fecal matter to a
selected average size, for example, the distance between threads is
selected. Alternatively or additionally, one or more cleaning
parameters are adjusted and/or controlled (e.g., automatically by a
controller, manually by a user) to result in the average size of
shredded particles, for example, the rate of rotation of the
crushing elements.
[0182] In some embodiments, additional graining effects can be
produced when helical devices 1218A and 1218B are caused to
overlap, as is shown in FIG. 12C. Overlapping helical devices can
provide efficient pumping action and/or can also contribute to
shredding the content of lumen 1216.
[0183] Helical devices 1218A and 1218B can be helical springs, can
be rods and/or pipes surrounded by a helical thread, can be formed
as a helical brush similar to those used to clean colonoscope
working channels, and/or can be a wire or a rope wire made from
stainless steel or another material.
[0184] Components having forms other than helical can also be used
in one or both of lobes 1210 and 1212. An example is given in FIG.
12D, where two paddle-shaped forms 1222A and 1222B are provided in
place of helical devices 1218A and 1218B. Rotating paddles create
turbulence which generates shearing and/or tearing forces. Other
shapes may also be used, and labels 1222A and/or 1222B should be
understood to refer to these shapes also. In general any shape may
be used which provides turbulence within lumen 1216 and/or which
tends to propel materials proximally within lumen 1E.
[0185] In some embodiments of the invention, the shapes used in
lumen 1216 vary along the length of the lumen. For example, a
paddle shape as shown in FIG. 12D could be provided at a distal end
of lumen 1216, a propeller shape could be provided distal to the
paddle shape along the same axes of lobes 1210 and 1212, and/or a
helical device could be provided at more proximal portions of those
lobes. If we refer to all these shapes extending the length of
lobes 1210 and 1212 as "driving devices", then in some embodiments
device 1200E may be provided with a variety of driving devices from
among which a user may select the combination to be used depending
on characteristics of the patient or any particular desired effect
or desired effect of the cleaning process. In general, in some
embodiments each driving device is free to rotate within its lobe
and/or may be free to independently advance and retract within its
lobe, yet each driving device is constrained so that a longitudinal
axis of each driving device is retained (by the shape of lumen
1216) within one of the lobes.
[0186] FIG. 12E provides an additional alternative embodiment,
wherein more than two lobes are used in an exhaust conduit 1224, in
accordance with some embodiments of the invention. Note that in
these embodiments as well as in the other embodiments shown in
FIGS. 12A-12F, each lobe may contain a driving device, or
alternatively only some lobes may comprise a driving device and
others may be empty of devices and available for the moving exhaust
matter itself. FIG. 12E shows a central lobe 1226 which comprises a
driving device (shown as a helical device 1228), while side lobes
1210 and 1212 are empty.
[0187] FIG. 12F shows an embodiment similar to that of FIG. 12E,
but wherein a driving device is embodied as a rotatable brush 1230
within lobe 1226 but whose flexible bristles are long enough to
penetrate into side lobes 1210 and 1212. Empty space is provided in
lobes 1210 and 1212 to optionally facilitate transportation of
objects out of the body, while also optionally providing a source
for driving power and/or a source of turbulence and/or possibly
shredding and/or cutting activities accomplished by bristles from
brush 1230.
Using Multiple Conduits and Shaped Conduits to Reduce Overall Cross
Section of a Cleaning Device
[0188] In some embodiments, the device used to clean the colon
passes the anal sphincter and/or a speculum to enter the colon.
Once in the colon, the device may be maneuverable within the colon,
which may includes several sharp curves. A device with reduced
cross-section may be suitable for such a task.
[0189] Attention is now drawn to FIGS. 12G-12I, which present
cleaning device configurations in which multiple input conduits are
used to reduce the device cross-section, according to some
embodiments of the present invention.
[0190] A cleaning device 10A presented in FIG. 12G comprises an
evacuation lumen 1232 having a cross-section diameter S1. A housing
1234 (for example an extrusion housing) comprises a plurality of
fluid input conduits 1206 usable to introduce water into a colon.
The overall diameter of device 1200A is R1. Evacuation lumen 1232
may comprise a matter transportation mechanism such as mechanism
513 discussed with reference to FIG. 2A.
[0191] FIG. 12H presents a cleaning device 1200B which comprises an
endoscope or a colonoscope 1204. Endoscope 1204 is constructed
together with, or attachable to, an evacuation lumen 1232 having a
cross-sectional diameter S1. A housing 1202, optionally an
extrusion housing, comprises a plurality of fluid input conduits
1206 usable to insert water into a colon. The maximum diameter of
device 1200B is the diameter of circle R2 seen in FIG. 12H.
Evacuation lumen 1232 of FIG. 12H is shown as identical in diameter
to evacuation lumen 1232 shown in FIG. 12G, yet overall device
diameter (the diameter of circle R2 of FIG. 12H) is greater than
overall device diameter (the diameter of circle R1) of FIG. 12G.
The diameter of a colon is limited, and a large-bore device like
that shown in FIG. 12H could be problematic in several respects: it
would tend to be stiff, difficult to steer, and could cause pain
and retard recovery by damaging the intestinal wall of a
patient.
[0192] FIG. 12I provides a device 1200C which comprises an
endoscope 1204 and an evacuation lumen 1236 shaped as a flattened
and slightly curved ellipse whose cross-section S3 is shown in the
figure. Flattened lumen 1236 is advantageous over cylindrical lumen
1232 of FIG. 12H because an overall diameter of device 1200C
(diameter of circle R3 of FIG. 12I) is smaller than the overall
diameter (diameter of circle R2) of device 1200B, for an identical
evacuation lumen cross-sectional area.
[0193] In an exemplary embodiment of the invention, a device
comprises an evacuation lumen (e.g., lumen 1236) that is shaped
according to the endoscope that it is being connected to (e.g.,
endoscope 1204). A potential advantage is to reduce a profile size
of the combined device. For example, for a round endoscope 1204,
the lumen is shaped as a flattened and slightly curved ellipse
(e.g., crescent shaped), surrounding the endoscope, as illustrated
in FIG. 12I. In an exemplary embodiment of the invention, the
evacuation lumen comprises one or more indentations (e.g., shoulder
1220 as illustrated in FIGS. 12A-F) to prevent lateral migration
and/or flailing of one or more matter removal devices (one or more
non-limiting examples include; devices 1218A and/or 1218B, paddles
1222A and/or 1222B, helical device 1228) inside the curved
evacuation lumen. A potential advantage of a relatively flattened
design of the evacuation tube is a cleaning device using rotating
forms to evacuate matter from the lumen, the device having a
relatively low profile.
Cleaning Module with Rod Filter
[0194] Attention is now drawn to FIGS. 3D (isometric view) and 3E
(cross sectional view inside a fluid filled colon) of an endoscopic
cleaning device 802 which comprises a filter 804, in accordance
with an exemplary embodiment of the invention. Filter 804 reduces
and/or prevents blockage of an output conduit 806 during cleaning
by matter such as feces. Optionally, filter 804 is dependent on
device 804 being coupled (e.g., by attachment elements 818 such as
bands) to colonoscope 530, for example, colonoscope 530 forms a
barrier and/or wall to a large gap in filter 804.
[0195] In an exemplary embodiment of the invention, filter 804
comprises a plurality of openings 808A-C to allow water and/or
waste matter to pass through into conduit 806. For example, 2, 6,
10, or other smaller, intermediate or larger number of openings are
used. A potential advantage of using a plurality of openings, is if
one or more openings are blocked by feces, one or more openings
will remain unblocked to allow the cleaning process to
continue.
[0196] In an exemplary embodiment of the invention, openings 808A-C
have at least one dimension that is relatively smaller than the
diameter of output conduit 806, for example, dimension of openings
808A-C is 3 mm-5 mm for a diameter of conduit 806 of 8 mm, or other
smaller, intermediate or larger combinations are used. The
dimensions and/or the relationship between the dimensions of
openings 808A-C and/or output conduit 806 are selected to prevent
relatively large fecal pieces 810 from entering and obstructing
outlet conduit 806. Additionally, dimensions and/or the
relationship between the dimensions is selected to allow relatively
small fecal pieces 822 to pass into a relatively larger output
conduit 806 without obstructing conduit 806. Optionally, feces are
shredded and/or ground into relatively smaller particles inside
output conduit 806 such as by rotational apparatus 513.
[0197] In an exemplary embodiment of the invention, opening 808A is
formed between colonoscope 530 and at least one pipe 816 supplying
fluid to at least one fluid input conduit 522. Opening 808B is
formed between pipe 816 and strut 820. Opening 808C is formed
between struts 820. Struts 820 are substantially parallel to the
long axis of device 820, forming openings 808A-C that are
substantially parallel to the direction of motion (e.g., forward
and/or reverse). In some embodiments, the substantially parallel
struts and/or openings have an angle of no more than 45 degrees
relative to the long axis, or no more than 30 degrees, no more than
15 degrees, or other smaller, intermediate or larger angles are
used. Other embodiments of filter 804 that serve similar functions
can have different sized and/or shaped openings, and/or be formed
by different structural elements. For example, filter can be a
screen over the opening to conduit 806.
[0198] In an exemplary embodiment of the invention, motion (e.g.,
forward, reverse, sideways) of device 802 during the cleaning
process serves to loosen and/or dislodge feces trapped in openings
808A-C (e.g., into conduit 806 or outside of filter 804), for
example, using frictional forces created between the colon wall and
trapped feces. A potential advantage of openings 808A-C being
substantially parallel to the direction of motion of device 802 is
aiding in loosening and/or dislodging the trapped feces.
[0199] In an exemplary embodiment of the invention, filter 804
prevents and/or reduces contact between the colon wall and
rotational apparatus 513. Optionally, apparatus 513 is located
sufficiently far from openings 808A-C, for example, a distance of
about 5 mm, 10 mm, 15 mm away, or other smaller, intermediate or
larger distances. Alternatively or additionally, apparatus 513 is
positioned to be substantially perpendicular to the colon wall
during cleaning. Alternatively or additionally, size of openings
808A-C is sufficiently small to keep colon tissue outside of filter
804.
Swirling Liquid Motion Produced by Circularly Directed Water
Jets
[0200] Attention is now drawn to FIGS. 4A-4F, which present an
endoscopic cleaning device 540 which comprises a set of water spray
nozzles 542 arranged around at least a portion of a circumference
of a conduit 544. In some embodiments of the invention, the
cleaning device comprises a tip 541 having a set of nozzles 542,
each nozzle of the set is aimed in a direction which imparts to a
jet of liquid issuing through it, a direction having a directional
vector which has a vector component not parallel to the longitude
axis vector of cleaner 540.
[0201] Such a jet might have a vector comprising at least 2
subvectors wherein (a) is a subvector collinear or parallel with
the longitude axis of cleaner 540 and (b) is a subvector tangent to
the circumference of tip 541. A workstation (not shown) supplies
pressurized fluid via pipe 543 to tip 541. Optionally, tip 541
houses an internal manifold which distributes the pressurized fluid
to nozzles 542. FIG. 4C shows a front view of the device 540
positioned within a colon. Straight arrows on the figure show
potential directions of the water jets from nozzles 542. Curved
arrows on the figure show the potential direction of an induced
swirling motion of liquid filling a section of the colon. FIG. 4D
shows a schematic isometric view of the tip 541 showing directions
of jets [JE] which generate the swirl/rotation effect [RO] shown in
the figure. FIG. 4D may be contrasted with FIG. 4E which shows a
tip comprising a set of nozzles. The nozzles in FIG. 4E are aimed
in a direction which imparts to a jet of liquid issuing through it
in a direction having a vector V[J] collinear or parallel to the
longitude axis vector V[E]. Such design of nozzles may generate a
forward motion of fluids within a colon lumen and/or produce
turbulence within the lumen's fluids, but may not produce a swirl
or rotation effect around the longitude axis of the endoscopic
device.
[0202] FIG. 4F is an additional view of tip 541 as shown in FIG.
4D. FIG. 4F shows a set of nozzles aimed in a direction which
imparts to a jet of liquid issuing through it in a direction having
a vector V[J] not collinear or parallel to the longitude axis
vector V[E] of cleaner 540. Jet direction V[J] comprises two
vectors;
[0203] (a) Vector V[PTE] (Parallel To Endoscope axis) is a vector
parallel to the longitude axis vector V[E] of cleaner 540 and;
[0204] (b) Vector V[TTC] (Tangent To Circumference) is a vector
tangent to the circumference of endoscopic device's tip 541, and
consequently perpendicular to a longitudinal axis of the
device.
Addition of those two vectors produces vector V[J]
{V[PTE]+V[TTC]=V[J]}. The angle between vector V[J] and vector
V[PTE] is marked in the drawing as (AN). This angle could vary
between 10.degree.-90.degree., with best cleaning results expected
between 30.degree.-60.degree..
[0205] In the paragraph above a single jet direction is described,
but tip 541 may comprise a plurality of jets, as shown in FIG. 4F.
Optionally, each jet is aimed in a similar manner with respect to
its own position on the tip circumference.
[0206] In FIG. 4F angles (AN) of each of the 3 jets are shown as
being equal, but in alternative embodiments there may be variations
in the angles AN of each of the jets. In some embodiments jet
vector V[J] comprises vectors V[PTE] and V[TTC] as described, and
an additional vector V[Z] perpendicular to V[PTE] and V[TTC]. Such
jets could be set in a polar array around the longitude axis of the
endoscopic device 540. The arrangement may generate an enhanced
swirling effect, for example, relatively improved cleaning
results.
[0207] When fluid is supplied under pressure and sprays through
nozzles 542 and passes into a fluid filling the colon, the effect
is to agitate (e.g., impart a rotating and/or swirling motion) the
colon-filling fluid (which is also likely to comprise swirling
chunks of fecal matter). This swirling liquid may dislodge fecal
matter adhering to the colon walls, producing the cleaning effects
described above.
[0208] In an embodiment shown in FIG. 4A, fluid jets are directed
forward from the distal end of cleaner 540. In an embodiment shown
in FIG. 4B, jets are directed in both distal and proximal
directions.
[0209] FIG. 4C shows nozzles 542 embedded in a nozzle ring 541,
which may be a full circular ring, a partial circle, or may have
some other form, but which comprises a plurality of nozzles
designed to work in coordination.
[0210] In some embodiments of the invention, jets of liquid from
nozzles 452 are directed to work in coordination with other liquid
swirling mechanisms such as rotating apparatus 517 (e.g., FIGS.
2A-2J). For example, the liquid pressure, liquid velocity and/or
angles of nozzles 452 are selected to have an additive effect in
creating relatively improved (e.g., stronger, faster) liquid
swirling in the colon when used together with rotating apparatus
517, such as compared to the use of nozzles 452 or apparatus 517
alone.
Backward-Pointing Water Jet
[0211] Attention is now drawn to FIG. 5A that comprises at least
one nozzle 548 aimed backwards (i.e. proximally), and which
generates a jet that flows into the opening of the output conduit
547. Such a jet can assist in forcing fecal matter into the distal
opening of conduit 547 and/or can serve to keep clean the distal
end of conduit 547, which might otherwise tend to get blocked by
accumulated fecal debris.
Cleaning Systems with Cameras
[0212] FIG. 5B presents an embodiment which comprises a camera 549
positioned to provide images in a proximal direction. In the
embodiment shown in the figure, the distal entrance to exhaust pipe
547 is within view of camera 549. Camera 549 can also be positioned
to provide other proximal views. Camera 549 can be coupled with LED
illuminating light sources
[0213] In FIG. 5C, a camera 549A is provided on cleaner 520 looking
forward toward the distal end of endoscope 530 to which it is
attached. Cameras 549 and 549A may be provided in addition to a
camera 504 provided in endoscope 530, providing a secondary
viewpoint useful, inter alia, in detection of polyps which may lie
hidden in a fold of the intestinal wall.
Cleaning Systems with Turbines
[0214] FIGS. 6A-6C present several embodiments in which a "turbine"
is provided within an evacuation conduit such as conduit 512
described above. As used herein, a "turbine" is defined as a
rotating helical device contained within an outer casing. Turbines
of this description are potentially useful in shredding lumps and
chunks of fecal matter which might otherwise block or impede flow
within a conduit 512 or similar conduit, and/or can in some cases
may provide more forceful suction than might be provided by a
standard helical device. Turbines are also potentially advantageous
in that friction between the outer surface of the turbine and body
conduit is relatively low, potentially enabling such a turbine to
be advanced or retracted within the conduit with relative ease.
[0215] FIG. 6A shows a turbine 551 used together with (and in this
exemplary embodiment, distally attached to) a helical apparatus
552. FIG. 6B shows a turbine 551 connected to a connector 553,
which may be a rope wire, or other kind of wire, or a flexible rod.
Each of these can power rotation of turbine 551 by transmitting
rotation motion to turbine 551 from an external motor (not shown).
FIG. 6C shows how several turbines (551A and 551B in the figure)
may be interconnected with a cable or a flexible rod.
Pulsing Systems
[0216] Attention is now drawn to FIGS. 7A-7F, which present
apparatus used to inject into the colon a sequential combination of
fluids in which fluid of a first kind alternates relatively rapidly
with fluid of a second kind. In some embodiments, a first fluid (A)
comprises water, purified water, saline, and/or water with
supplemental materials such as soap, and a second fluid (B)
comprises of gas or aerosol, wherein non-limiting examples of gas
include CO.sub.2, pressurized room air or other gas mixtures. In
some embodiments fluids A and B are caused to flow within an input
conduit in alternation, agitating the fluid and/or feces inside the
colon segment. Potentially relatively improved cleansing results
are produced.
[0217] FIG. 7A shows a fluid source module appropriate for
providing fluids in such a sequential combination. Valves and
mixing workstation 561C receives pressurized fluid A from source
561A and pressurized fluid B from source 561B. Valves and
workstation 561C comprises computer-controlled electrical valves,
or any other valve or orifice configuration to supply an
alternating sequence of fluids to conduit 562, which may connect,
for example, to a cleaner input conduit such as conduit 501 and/or
conduit 511B, both discussed above.
[0218] In an exemplary embodiment of the invention, the system
illustrated in FIG. 7A is used to supply a mixture of fluids A from
source 561A and fluid B from source 561B to conduit 562.
Optionally, mixing is passive, for example, operating in a manner
similar to a carburetor based on the Venturi effect. Alternatively
or additionally, mixing is active, for example, control (e.g.,
automatically by a controller, manually set by the user) of mixing
proportions is achieved by valves that control flow of the
fluids.
[0219] FIG. 7B shows flow of fluid A within a pipe 562, the flow
due to the external fluid pressure (P) supplied from workstation
561C. Fluid flow within a pipe potentially generates a friction
force that correlates inter alia with the length of the pipe. This
friction is represented in FIG. 7B by the small arrows marked "Fr"
along the length of the pipe.
[0220] FIG. 7C shows the effect when workstation 561C presents a
short supply burst of fluid A followed by a burst of fluid B in a
cyclical manner, generating an alternating flow within the pipe,
according to an embodiment of the present invention.
[0221] The lengths of pipe 562 are identical in FIGS. 7B and 7C,
but potentially the friction-indicating arrows are quite different.
Since fluid B is primarily a gas, it may have relatively negligible
friction when flowing within the pipe (562). Fluid A, a liquid, may
experience relatively more friction in the same pipe. Pressure
within sections containing fluid A is marked is marked "PA", and
pressure within sections containing fluid B is marked "PB". The
pressure of Fluid A (liquid) is 1.2 Bar, 2.2 Bar, 3.6 Bar, or other
smaller, intermediate or larger values are used. The pressure of
Fluid B is relatively higher than the pressure of Fluid A, 0.2 ATM
higher, 0.5 ATM higher, 0.7 ATM higher, or other smaller,
intermediate or larger values are used. Given the same conditions
(e.g. same pipe length, same pipe inner diameter, and same inlet
pressure) friction in the alternating cyclic flow as shown in FIG.
7C is lower than friction in the continuous flow of only fluid A as
shown in FIG. 7B. Hence use of alternating fluid flow as taught
above may result in relatively higher velocity of fluid A as it
reaches pipe outlet 562A, under the method of FIG. 7C. On the other
hand, when using this alternating cyclic flow, relatively lower
amounts of fluid A may be transported in to the body.
[0222] It is noted that when injecting fluids into the human body
it may be necessary to set upper limits to the amount of pressure
used, such as for safety reasons. Standard medical practice
provides an upper safety limit to the amount of pressure that may
be injected into the body. For example, pressure should be below
100 mbar, below 76 mbar, below 50 mbar, or other smaller,
intermediate or larger pressure thresholds are used. The method
shown in FIG. 7C, comprising alternating rapidly between supplying
fluid A and supplying fluid B, may engender a higher velocity
delivery of fluid A, without exceeding safety limitations on the
amount of pressure supplied. Such higher-velocity intermittent
delivery of fluid A is highly appropriate and useful in a jet used
for dismantling chunks of feces, for example. Consequently a
cleaning system utilizing a fluid source as shown in FIG. 7A and
producing a flow as shown in FIG. 7C may present relatively better
cleaning results, without using relatively higher water
pressures.
[0223] Illustrated in FIGS. 7D-7F are successive stages in use of a
device (560) that comprises an inlet pipe (562) and an outlet pipe
(not shown). The inlet pipe is supplied with the alternating cyclic
flow as described above, provided from a workstation (not
shown).
[0224] Consider what happens when pressure of the fluids in inlet
pipe 562 is set, for example, to 2 ATM, assuming that the pressure
of fluids filling the colon (P.CO) is set in the normal range of 1
ATM. When a portion of fluid A under 2 ATM pressure is contained
within the pipe's tip 562B as shown in FIG. 7D, flow of fluid A may
be smooth. Since fluid A is composed primarily of water, it may not
expand appreciably when ejected into a colon filled with water and
fecal matter at 1 ATM pressure (P.CO). As shown in FIG. 7E, a small
shock wave 563A will potentially be generated due to the flow of a
portion of fluid A into the colon lumen.
[0225] When fluid A completely exits the pipe's tip 562B as
illustrated in FIG. 7F, the portion of fluid B following may be
free to burst out of the pipe's outlet. Fluid B, primarily a gas
(at 2 ATM pressure in this exemplary embodiment), expands rapidly
to double its volume in the 1 ATM pressure of the colon. This
sudden gas expansion generates a relatively big shock wave, shown
in FIG. 7F as 563C.
[0226] In an exemplary embodiment of the invention, at least some
of the gas and/or other fluids (e.g., fluids A and/or B) are
discharged by the patient in the natural manner through the anal
sphincter, for example, preventing a build-up of excess gas and/or
fluids. Alternatively or additionally, discharging occurs through
an output conduit (e.g., conduit 512).
[0227] This alternating cyclic flow system can result in one or
both of two advantageous outcomes when working in a colon full of
water & fecal matter:
[0228] (i) It provides a means for producing a high-powered jet
while yet limiting the pressure to which the human body is exposed.
This effect can be used both in a colon filled with water and in a
colon filled with air or other gas.
[0229] (ii) Vibration inside the colon caused by cyclic shockwaves
like 563C shown in FIG. 7F enhance the jet's ability to break down
fecal matter into small parts and helps "peel" fecal matter from
the colon wall. This effect is primarily useful in a colon full of
water and fecal matter. Unlike water jets, which work in a
directional way and therefore have a directionally limited effect,
the rapid repetitive effect of shockwaves 563C is omni-directional,
and therefore produces rapid widespread cleaning results while
largely eliminating the need for carefully directed steering of the
cleaning tool by an operator. In other words, the system does
relatively better cleaning and is relatively easier to use.
Exemplary Control System
[0230] FIG. 10 illustrates an exemplary control system 1000 for
cleaning body cavities such as the human colon, in accordance with
an exemplary embodiment of the invention. System 1000 provides for
the control and/or monitoring of the cleaning.
[0231] In an exemplary embodiment of the invention, an operator
(e.g., physician performing the procedure) programs a controller
1002 (e.g., computer) for cleaning using a user interface 1004
(e.g., keyboard, mouse, monitor). Optionally, treatment is
monitored, for example, by viewing feedback parameters on interface
1004.
[0232] In some embodiments of the invention, interface 1004
provides feedback about the cleanliness of the colon segment.
Non-limiting examples of the feedback include; signaling to the
physician performing the procedure to check the cleanliness of the
colon segment, signaling that the colon segment has been cleaned
and optionally proceeding to the next colon segment (e.g., asking
for permission from the user to advance). Optionally, the
cleanliness of the colon segment is checked by a user and/or
sensor, non-limiting examples include; the physician visually
inspecting the segment (e.g., using optical equipment), a sensor
measuring the opacity of the fluid being removed from the segment.
Optionally, the feedback is provided to controller 1002, for
example, controller 1002 signals the device to continue functioning
until the colon has been sufficiently cleaned.
[0233] In an exemplary embodiment of the invention, controller 1002
is coupled to a memory 1006, for example, memory 1006 is stored
thereon, memory 1006 is stored on user interface 1004 and/or memory
1006 is remotely accessible, for example, by a communication link
1008 (e.g., wireless and/or wired connection).
[0234] In an exemplary embodiment of the invention, the cleaning is
controlled by controller 1002 according to logic (e.g., a software
module), for example using a data table. Optionally, the table is
stored on memory 1006. In an exemplary embodiment of the invention,
the table contains at least one cleaning parameter, optionally
correlated with one or more other parameters, for example,
according to clinical indications. Optionally, the cleaning
parameters are based on trial and error, for example, empirical
data collected from the patient currently being cleaned with the
colon cleaning device (e.g., during the cleaning) and/or previously
collected from a group of patients such as part of a study in
patients have similar clinical indications. Optionally or
additionally, one or more functions and/or parameters are
selectable (e.g., manually set by a user, automatically selected by
software).
[0235] In an exemplary embodiment of the invention, controller 1002
is coupled to one or more elements such as: [0236] Output conduit
1010 for removing fluids and/or feces from the colon, for example,
output conduit 512 as described with reference to the section
"Filing the colon with liquid, swirling the liquid". [0237] Input
conduit 1012 for inserting fluids into the colon, for example,
input conduit 511A as described with reference to the section
"Filing the colon with liquid, swirling the liquid". [0238]
Agitator 1014 for agitating the liquid in the colon (e.g.,
swirling, vibrating), for example, rotating apparatus 517 as
described with reference to the section "Filing the colon with
liquid, swirling the liquid". [0239] At least one spray nozzle 1016
for agitating the liquid in the colon, for example, water spray
nozzles 542 as described with reference to the section "Swirling
liquid motion produced by circularly directed water jets", and/or
nozzle 548 as described with reference to the section "Backward
pointing water jet". [0240] Shredding apparatus 1018 for shredding
the feces, for example, rotatable device 1218A/B as described with
reference to the section "Exemplary embodiments for graining and/or
exhausting fecal matter". [0241] Pulsing system 1020 comprising a
mechanism for mixing and/or alternating a pressurized liquid source
and a pressurized air source, for example, as described with
reference to the section "Pulsing systems". [0242] At least one
sensor 1022, for example, for measuring input flow rates (e.g.,
fluid meters 600A and/or 600B), output flow rates (e.g., scales 608
and/or 608A), for determining fluid levels (e.g., sensor 736).
[0243] One or more non-limiting examples of settable parameters
include: [0244] Cleaning efficiency--is the amount of waste and/or
feces removed from the colon during cleaning, for example, at least
90%, at least 95%, at least 99%, about 100%, or other smaller,
intermediate or larger percentages are used. In some embodiments,
cleaning efficiency is estimated by analyzing the fluid removed
from the colon, for example, by a sensor analyzing the opacity of
the removed fluid. [0245] Rotation rate of the fluid in the
colon--the axial rotation of the filling fluid and/or waste matter
in the colon (e.g., portion thereof) caused by the rotational
apparatus. For example, greater than 20 RPM, greater than 30 RPM,
greater than 50 RPM, or other smaller, intermediate or larger
values are used. [0246] Percentage of the filling liquid rotating
around a longitudinal axis of the colon portion--the axial rotation
caused by the rotational apparatus. For example, greater than 40%,
greater than 50%, greater than 75%, about 100%, or other smaller,
intermediate or larger values are used. [0247] Fluid pulsing
parameters--for example, pressure of the pulsing liquid such as 1.2
bar, 2.2 bar, 3.6 bar, or other smaller, intermediate or larger
values. For example, the volume of the pulse of liquid. For
example, the frequency of the pulses of liquid. [0248] Gas pulsing
parameters--for example, pressure of the gas such as 1.2 bar, 2.1
bar, 2.4 bar, 3.6 bar, or other smaller, intermediate or larger
values. For example, pressure of the gas relative to the pressure
of the alternating liquid, such as larger by 0.2 ATM, 0.5 ATM, 0.7
ATM, or other smaller, intermediate or larger pressures. For
example, the volume of the pulse of gas. For example, the frequency
of the gas pulses. [0249] Agitator rotation rate--rotation rate of
the rotating element. [0250] Agitator longitudinal
vibration--frequency of vibration along the longitudinal axis
(e.g., forward and backward motion). [0251] Agitator rotational
vibration--frequency of vibration caused during rotation of the
rotation element (e.g., side to side motion substantially
perpendicular to the longitudinal axis). [0252] Size of shredded
fecal matter--average size of particles once shredded.
[0253] One or more non-limiting examples of selectable parameters
include: [0254] Cleaning rate--is the rate of advancement of the
colon cleaning device. [0255] Liquid input rate--is the rate at
which the cleaning fluid (e.g., water, saline) is inserted into the
colon. [0256] Output rate--is the rate of removal of the cleaning
fluid along with any waste matter (e.g., feces) from the colon.
[0257] Colon fill proportion--is the amount of liquid in the colon
(e.g., colon segment) during cleaning. Can be set to a constant
value, or can be variable such as to maintain the cleaning device
fully submerged in liquid. [0258] Pressure of colon--ambient
pressure during cleaning. [0259] Colon pressure change--is the
change in the ambient pressure of the colon (e.g., colon segment)
during cleaning, relative to the pressure before cleaning. [0260]
Colon liquid rotation rate--rotation of the inserted liquid and/or
feces caused by the rotation element and/or spray jets.
SOME EXAMPLES OF EXPECTED EFFECTS ASSOCIATED WITH VARIABLES
[0261] The following are some non-limiting examples illustrating
some parameters under control, and their association with some
expected treatment effects, in accordance with an exemplary
embodiment of the invention: [0262] Cleaning rate--In some
embodiments, the cleaning rate is set (e.g., by the user) and the
device advanced at the specified rate. Alternatively, the cleaning
rate is a function of the cleaning parameters, and may vary by the
amount of feces in the colon and/or other cleaning parameters
(e.g., input and/or output flow rates, vibration). For example, at
least 5 cm/min, at least 10 cm/min, at least 15 cm/min, or other
smaller, intermediate or larger rates are used. [0263] Liquid input
rate--A faster liquid input rate results in a faster cleaning rate
and/or higher cleaning efficiency. The liquid input rate is
balanced by a suitable output rate to maintain a set colon fill
proportion, and/or pressure in the colon. [0264] Output rate--A
faster output rate results in a faster cleaning rate and/or higher
cleaning efficiency. The output rate is balanced by a suitable
input rate (e.g., equal or greater rate, taking into account the
removal of feces in the colon) to maintain a set colon fill amount,
and/or pressure in the colon. [0265] Colon fill proportion--A
relatively higher colon fill proportion potentially results in a
faster cleaning rate and/or a higher cleaning efficiency, for
example, the `swirling` and/or `shocks` potentially remove and/or
break down relatively larger amounts of feces. [0266] Colon
pressure--should be maintained within a threshold range in order to
maintain a safe working pressure (e.g., reduce and/or prevent
adverse events). Controlled at least in part by the input and/or
output rates. [0267] Change in colon pressure--positive and/or
negative pressure swings should be maintained within a threshold in
order to maintain a safe working pressure. Controlled at least in
part by the input and/or output rates. [0268] Pulsing parameters
(gas and/or liquid)--may be used to create relatively smaller or
relatively larger `shock waves` in the colon, dislodging relatively
larger and/or relatively smaller amounts of feces. For example, a
relatively higher gas pressure causes a relatively higher shock.
[0269] Colon liquid rotation rate--a colon liquid rotation rate
dislodges relatively larger amounts of feces and/or results in a
faster rate of removal. [0270] Agitator rotation rate--a higher
axial rotation rate causes a higher colon liquid rotation rate.
[0271] Size of shredded fecal matter--a relatively small average
particle size results in relatively higher cleaning rates and/or
reduced risk of blocking the output conduit.
Systems for Maintaining Colon Fill Levels: Measuring
Input/Output
[0272] Attention is now drawn to FIG. 8, which presents a system
for precision measuring of (a) fluids inserted into the body and
(b) fecal matter and fluids coming out of the body, which is useful
for striking a balance between the two, according to an embodiment
of the present invention.
[0273] Device 640 (optionally built into an endoscope or mounted on
an endoscope) has a tip 601 designed to be inserted into the body
via the rectum. Workstation 600, using a pump 600A and a fluid
meter 600B, supplies fluids via pipes 602 to the device tip 601.
Fecal matter and fluids emerges from the body in two ways: (a) via
the device's evacuation pipe 603 to fluids separator 604 and to
draining pipe 606, or (b) via the rectum. For safety reasons, it is
critically important to accurately estimate the amount of fluids
within the body in real-time, for example to avoid introducing
excessive fluids which might do bodily damage. Device 640 supplies
this need.
[0274] Device 640 comprises Y junction 604. Junction 604 receives
rotational power via a connector 605 from working station 600,
which rotational power activates a helical apparatus within
inserted cleaner 603, as taught above. Fluids and fecal matter
transported by the helical apparatus to junction 604 is caused to
drop down into draining pipe 606 and is prevented from entering
connector 605. Fluids and fecal matter dropping down draining pipe
606 will reach a collection box 607 where it can be measured in
real time using a scale 608. A similar procedure takes place for
measuring fluid and fecal matter which appears in collector 609
after exiting spontaneously from the rectum.
[0275] Data from scales 608 and 608A and data from input pump 600A
and fluid meter 600B within working station 600 can then be used in
a simple subtractive calculation to determine in real-time how much
fluid is housed within the patient colon in any given moment. This
is important since overloading the patient's colon with water may
be harmful.
[0276] In some embodiments, workstation 600 comprises a controller
620 which receives information from scales 608 and 608A and from
fluid meter 600A, calculates an estimate of the amount of residual
inserted fluid is currently in the colon, calculates a command
based on this estimate, and sends that command to pump 600B, which
then pumps a calculated amount of additional fluid into the colon
so as to maintain an optimal operating environment for cleaning
device 601.
Systems for Maintaining Colon Fill Levels: Measuring Water
Levels
[0277] Attention is now drawn to FIG. 9A, which is a cleaning
device 700 able to calculate a ratio of gaseous material to
non-gaseous material (i.e. liquid, fecal matter or other solid)
within a colon segment, in accordance with some embodiments of the
invention.
[0278] Device 700 is a cleaning device similar to any of the
cleaning devices discussed above. In particular device 700 may
comprise an insertable portion 733 which comprises a helical
rotating device as described above, powered by a rotating connector
attached to a motor 735A in a workstation transmitting rotating
motion through a connector 735. An operating tip 731 at a distal
portion of insertable portion 733 comprises a sensor 736, which may
be used to trigger an automatic response within workstation
730.
[0279] Sensor 736 provides information useable by a controller 730D
to calculate commands to a water pump 730B for pumping water or any
liquid. In some embodiments, workstation 730 comprises a controller
730D which receives information from sensor 736, uses that
information to calculate an estimate of the amount of liquid needed
to maintain an optimal operating environment for cleaning device
700, and calculates a command to pump 730B, commanding pump 730 to
pump (or not pump) liquid accordingly.
[0280] In some embodiments sensor 736 is an ultrasound transducer
which generates a signal that could tell the workstation (or show
an operator) exactly the how much water or liquid, vs. air or other
gas, surrounds tip 731 of the device. This procedure can yield
precise information about the liquid concentration around tip 731,
aiding system 700 (which may also use other sensors, such volume
sensors, or flow meters and controllable pumps and scales as shown
in FIG. 8), to supply an optimal amount of liquid to a lumen
segment being cleaned.
[0281] In some embodiments sensor 736 senses and reports whether
tip 731 is within water environment or within a gas environment.
Several kinds of sensors can accomplish this task. For example,
sensor 736 may comprise a module for measuring electric resistance
around tip 731, Alternatively, sonic feedback could be used to
determine material density around sensor 736.
[0282] Sensor 736 could be a colonoscope camera, or other camera.
An image from such a camera could be processed by image processing
software, and amounts of water in the intestine could be
ascertained. Image processing software can also be used to examine
the color of the light reaching the camera, to determine whether
camera 736 is currently located in water (liquid) or in air or
other gas. In some embodiments, signals received from sensor 736
are processed by controller 730D to run system 700 under
algorithmic control. Sensor 736 enables system 700 to "know"
whether there is an optimal amount of water in the colon, and to
control pump 730B and rotational element 735 to achieve an optimal
amount of water in the colon at the cleaning site. Alternatively,
information derived from sensor 736 can be provided to a user, who
then exercises manual control of operations of system 700, e.g. by
increasing water flow by pushing a control button when he observes
through a visualization modality that the distal tip of the
cleaning device is out of the water.
Combinations
[0283] Elements in this section will be referenced according to
FIG. 10, representing a non-limiting embodiment.
[0284] In some embodiments of the invention, there is more than one
element as described herein. Non-limiting examples include; there
may be more than one agitators 1014, more than one pulsing systems
1020, more than one input conduits 1012, more than one sensors
1022, more than one shredding apparatus 1018, more than one
controller 1002 and/or more than one memory 1006. In some
embodiments of the invention, one type of element can serve as two
or more elements as described herein. For example, rotational
element 513 and/or 517 as described with reference to FIG. 2A can
serve as an agitator 1014 and as a shredding apparatus 1018. For
example, pulsing system 1020 can serve as an input conduit 1012, an
agitator 1014 and/or as shredding apparatus 1018. For example,
input 1012 conduit can also serve as output conduit 1010.
[0285] In some embodiments of the invention, one type of element
can be external to the cleaning device, for example, as an external
component optionally coupled to the cleaning device. For example,
input conduit 1012 and/or output conduit 1010 can be in the form of
a separate tube inserted from outside the body into the colon
segment being cleaned.
[0286] Embodiments of the invention can include any combination or
sub-combination of the above listed features and/or element. The
embodiments described are not meant to limit the invention.
Experiments
[0287] Some of the embodiments presented above have been tested in
in vivo animal experiments. A non-limiting example of an experiment
is described:
[0288] Animal: each of 3 female pigs weighing 85-105 kg underwent 3
cleaning procedures separated by a week between the cleanings. The
animals had partly prepared or unprepared colons.
[0289] Device: an experimental prototype, having an embodiment
similar to that illustrated in FIG. 3D (including additional
elements such as the shredding mechanism similar to that of FIG.
3A) was attached to a standard colonoscope and inserted into the
colon via the anal sphincter.
[0290] Flow rates: fluid input and mixture (e.g., feces and/or
fluid) output flow rates of between 500 cc/minute and 3000
cc/minute were tested.
[0291] Pulsing system: the fluid-fecal mixture inside the colon was
agitated using alternating liquid/gas pulsed segments (e.g., as
described in the section "Pulsing systems").
[0292] Rotational element: the fluid-fecal mixture inside the colon
was agitated using a helical device (e.g., device 513 and/or 517)
with applied rotational speeds of between 700 rpm and 7000 rpm. The
induced rotation rate of the liquid in the liquid-filled colon was
observed using a camera inside the colon segment.
[0293] Results: The colon segment in each of the pigs was visually
inspected using the colonoscope, and was determined to be cleaned.
Cleaning was achieved in unprepared and partly prepared colons.
[0294] Conclusion: Inserting fluid into the colon segment,
agitating the fluid-fecal mixture inside the colon segment using
the pulsing system and/or the rotational element, and removing the
mixture provides satisfactory cleaning of the colon segment.
[0295] It is expected that during the life of a patent maturing
from this application many relevant endoscopes and colonoscopes
will be developed and the scope of the terms "endoscope" and
"colonoscope" is intended to include all such new technologies a
priori.
[0296] The terms "comprises", "comprising", "includes",
"including", "having" and their conjugates mean "including but not
limited to".
[0297] The term "consisting of means "including and limited
to".
[0298] As used herein, the singular form "a", "an" and "the"
include plural references unless the context clearly dictates
otherwise.
[0299] 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 sub-combination
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.
[0300] Although the invention has been described in conjunction
with specific embodiments thereof, it is evident that many
alternatives, modifications and variations will be apparent to
those skilled in the art. Accordingly, it is intended to embrace
all such alternatives, modifications and variations that fall
within the spirit and broad scope of the appended claims.
[0301] All publications, patents and patent applications mentioned
in this specification are herein incorporated in their entirety by
reference into the specification, to the same extent as if each
individual publication, patent or patent application was
specifically and individually indicated 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.
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