U.S. patent number RE46,007 [Application Number 14/628,972] was granted by the patent office on 2016-05-24 for automated control of irrigation and aspiration in a single-use endoscope.
This patent grant is currently assigned to Boston Scientific Scimed, Inc.. The grantee listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to Michael S. Banik, Lucien Alfred Couvillon, Anh Nguyen, William H. Stahley.
United States Patent |
RE46,007 |
Banik , et al. |
May 24, 2016 |
Automated control of irrigation and aspiration in a single-use
endoscope
Abstract
The present invention is an integrated and automated irrigation
and aspiration system for use in an endoscopic imaging system. The
system provides for the automated cleaning of poorly prepared
patients during a colonoscopy procedure as well as automated
cleaning of an imaging system of an endoscope. The invention
analyzes images obtained from an image sensor to detect the
presence of an obstructed field of view, whereupon a wash routine
is initiated to remove the obstruction. The wash routine may be
adjusted in accordance with environmental conditions within the
patient that are sensed by one or more sensors within the
endoscope. In another embodiment, insufflation is automatically
controlled to inflate a patient's colon as a function of one or
more sensor readings obtained from one or more environmental
sensor(s) on the endoscope.
Inventors: |
Banik; Michael S. (Bolton,
MA), Couvillon; Lucien Alfred (Concord, MA), Nguyen;
Anh (Woburn, MA), Stahley; William H. (Andover, MA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc. |
Maple Grove |
MN |
US |
|
|
Assignee: |
Boston Scientific Scimed, Inc.
(Maple Grove, MN)
|
Family
ID: |
35629455 |
Appl.
No.: |
14/628,972 |
Filed: |
February 23, 2015 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
10955901 |
Jan 20, 2009 |
7479106 |
|
|
Reissue of: |
12330470 |
Dec 8, 2008 |
8435172 |
May 7, 2013 |
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
1/00103 (20130101); A61B 1/015 (20130101); A61B
1/00068 (20130101); A61B 1/0008 (20130101); A61B
1/126 (20130101); A61B 1/05 (20130101); A61B
1/12 (20130101); A61B 1/127 (20130101) |
Current International
Class: |
A61B
1/12 (20060101); A61B 1/00 (20060101) |
Field of
Search: |
;600/101-183 |
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April 2001 |
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July 2001 |
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August 2001 |
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Shipp |
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September 2002 |
Acker |
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September 2002 |
Teller |
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October 2002 |
Okada |
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October 2002 |
Sendai |
6475141 |
November 2002 |
Abe |
6478730 |
November 2002 |
Bala |
6489987 |
December 2002 |
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December 2002 |
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December 2002 |
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January 2003 |
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February 2003 |
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Primary Examiner: Flanagan; Beverly M
Attorney, Agent or Firm: Bookoff McAndrews, PLLC
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application .Iadd.is a reissue application of U.S. Pat. No.
8,435,172, which issued from U.S. patent application Ser. No.
12/330,470, filed Dec. 8, 2008, which .Iaddend.is a continuation of
U.S. patent application Ser. No. 10/955,901, filed Sep. 30, 2004,
.Iadd.now U.S. Pat. No. 7,479,106, .Iaddend.the disclosure of which
is expressly incorporated herein by reference.
Claims
The embodiments of the invention in which an exclusive property or
privilege is claimed are defined as follows:
1. A system for automatically controlling the delivery of
.[.insufflation gas.]. .Iadd.gas or liquid to a patient.Iaddend.,
the system comprising: .[.a control cabinet including.]. a
processor .[.and one or more valves.]. configured to control the
delivery of .[.insufflation.]. gas .Iadd.or liquid .Iaddend.to
.[.a.]. .Iadd.the .Iaddend.patient; and an .[.endoscope removably
connected to the control cabinet and.]. .Iadd.elongate member
.Iaddend.including a pressure sensor and an image sensor at
.Iadd.or adjacent .Iaddend.a distal end of the .[.endoscope.].
.Iadd.elongate member.Iaddend.; wherein the processor is configured
to obtain .Iadd.an .Iaddend.image .[.signals.]. .Iadd.signal
.Iaddend.from the image sensor and .Iadd.a .Iaddend.pressure
.[.readings.]. .Iadd.reading .Iaddend.from the pressure sensor and
automatically control .[.insufflation.]. gas .Iadd.or liquid
.Iaddend.delivered to the patient as a function of the image
.[.signals.]. .Iadd.signal .Iaddend.and the pressure .[.readings.].
.Iadd.reading.Iaddend..
2. The system of claim 1, wherein the delivery of
.[.insufflation.]. gas is controlled to maintain a predefined field
of view in the image .[.signals.]. .Iadd.signal .Iaddend.produced
by the image sensor.
3. The system of claim 1, further comprising a sensor configured to
determine a size of an inflated body cavity, and wherein the
processor is configured to control the delivery of
.[.insufflation.]. gas to maintain a predetermined inflated cavity
size.
4. The system of claim 1, wherein the processor is configured to
control the delivery of .[.insufflation.]. gas to maintain a
predetermined pressure in a body cavity.
5. The system of claim 1, further comprising a sensor configured to
detect a thickness of a tissue wall surrounding the .[.endoscope.].
.Iadd.elongate member.Iaddend., and wherein the processor is
configured to control the delivery of .[.insufflation.]. gas as a
function of the wall thickness detected.
.[.6. The system of claim 1, wherein the endoscope is
dispensable..].
7. A system for automatically controlling the delivery of
.[.insufflation gas.]. .Iadd.fluid.Iaddend., the system comprising:
a control .[.cabinet.]. .Iadd.unit .Iaddend.including a processor
.[.and at least one valve.]. configured to control the delivery of
.[.insufflation gas.]. .Iadd.fluid.Iaddend.; and an endoscope
removably connected to the control .[.cabinet.]. .Iadd.unit
.Iaddend.and including a pressure sensor and an image sensor at
.Iadd.or adjacent .Iaddend.a distal end of the endoscope; wherein
the processor is configured to receive .Iadd.an .Iaddend.image
.[.signals.]. .Iadd.signal .Iaddend.from the image sensor and
.Iadd.a .Iaddend.pressure .[.readings.]. .Iadd.reading
.Iaddend.from the pressure sensor and automatically control the
delivery of .[.insufflation gas.]. .Iadd.fluid .Iaddend.as a
function of the image .[.signals.]. .Iadd.signal .Iaddend.and the
pressure .[.readings by controlling actuation of the at least one
valve.]. .Iadd.reading.Iaddend..
8. The system of claim 7, wherein the processor is configured to
control the delivery of .[.insufflation gas.]. .Iadd.fluid
.Iaddend.to maintain a predefined view produced by the image
sensor.
9. The system of claim 7, wherein the processor is configured to
control the delivery of .[.insufflation gas.]. .Iadd.fluid
.Iaddend.to maintain a predetermined pressure in the body cavity
and to maintain a predefined view produced by the image sensor.
10. The system of claim 7, wherein the control .[.cabinet.].
.Iadd.unit .Iaddend.includes a manifold configured to supply
.[.insufflation.]. .Iadd.at least one of .Iaddend.gas, .[.a.].
liquid, and aspiration to the endoscope.
11. The system of claim 10, .[.wherein the.]. .Iadd.further
including .Iaddend.at least one valve .Iadd.that .Iaddend.is
configured to control the supply of .[.insufflation.]. .Iadd.at
least one of .Iaddend.gas, .[.the.]. liquid, and aspiration from
the manifold.
.[.12. The system of claim 11, wherein the endoscope is removably
coupled to the manifold..].
13. A system for automatically controlling the delivery of
.[.insufflation.]. gas .Iadd.or liquid.Iaddend., the system
comprising: a control .[.cabinet.]. .Iadd.unit .Iaddend.including a
processor and at least one valve configured to control the delivery
of .[.insufflation.]. gas .Iadd.or liquid.Iaddend.; and an
endoscope removably connected to the control .[.cabinet.].
.Iadd.unit .Iaddend.and including a pressure sensor configured to
determine a pressure in a body cavity and an image sensor; wherein
the processor is configured to receive .Iadd.an .Iaddend.image
.[.signals.]. .Iadd.signal .Iaddend.from the image sensor and
.Iadd.a .Iaddend.pressure .[.readings.]. .Iadd.reading
.Iaddend.from the pressure sensor and automatically control the
delivery of .[.insufflation.]. gas .Iadd.or liquid .Iaddend.as a
function of the image .[.signals.]. .Iadd.signal .Iaddend.and the
pressure .[.readings.]. .Iadd.reading .Iaddend.to maintain a
predetermined pressure in the body cavity by controlling actuation
of the at least one valve.
14. The system of claim 13, wherein the processor is configured to
control the delivery of .[.insufflation.]. gas .Iadd.or liquid
.Iaddend.to maintain the predetermined pressure in the body cavity
and to maintain a predefined view produced by the image sensor.
15. The system of claim 13, wherein the control .[.cabinet.].
.Iadd.unit .Iaddend.includes a manifold configured to supply
.[.insufflation.]. gas, .[.a.]. liquid, and aspiration to the
endoscope.
16. The system of claim 15, wherein the at least one valve is
configured to control the supply of .[.insufflation.]. gas,
.[.the.]. liquid, and aspiration from the manifold.Iadd., wherein
the endoscope is removably coupled to the manifold.Iaddend..
.[.17. The system of claim 16, wherein the endoscope is removably
coupled to the manifold..].
.Iadd.18. The system of claim 1, wherein the elongate member is an
endoscope. .Iaddend.
.Iadd.19. The system of claim 18, wherein a control cabinet
includes the processor and one or more valves configured to control
the delivery of gas or liquid to the patient, and wherein the
endoscope is removably connected to the control cabinet.
.Iaddend.
.Iadd.20. The system of claim 19, wherein the processor is
configured to obtain image signals from the image sensor and
pressure readings from the pressure sensor and automatically
control gas or liquid delivered to the patient as a function of the
image signals and the pressure readings. .Iaddend.
.Iadd.21. The system of claim 7, wherein the control unit is a
control cabinet that further includes at least one valve, and the
processor is configured to control the delivery of fluid by
controlling actuation of the at least one valve. .Iaddend.
.Iadd.22. The system of claim 21, wherein the processor is
configured to receive image signals from the image sensor and
pressure readings from the pressure sensor and automatically
control fluid delivered to the patient as a function of the image
signals and the pressure readings. .Iaddend.
.Iadd.23. The system of claim 13, wherein the control unit is a
control cabinet, and wherein the processor is configured to obtain
image signals from the image sensor and pressure readings from the
pressure sensor and automatically control gas or liquid delivered
to the patient as a function of the image signals and the pressure
readings. .Iaddend.
Description
FIELD OF THE INVENTION
The present invention relates to an endoscope system. In
particular, it relates to an integrated and automated irrigation
and aspiration system for use in an endoscope system.
BACKGROUND OF THE INVENTION
Endoscopes have been used for many years in the medical field to
look within a selected region of a patient's body or to perform
surgical, therapeutic, diagnostic, or other medical procedures
under direct visualization. A conventional endoscope generally
contains several components including illuminating means such as
light-emitting diodes or fiber optic light guides connected to a
proximal source of light, an imaging means such as a miniature
video camera or a fiber optic image guide, and a working channel.
These components are positioned within an endoscope sheathing tube.
Flexible or steerable endoscopes also incorporate an elongated
flexible shaft and an articulating distal tip to facilitate
navigation through the internal curvature of a body cavity or
channel.
Colonoscopy is a medical procedure in which a flexible endoscope,
or colonoscope, is inserted into a patient's colon for diagnostic
examination and/or surgical treatment of the colon. A standard
colonoscope is typically 135-185 cm in length and 12-13 mm in
diameter. Colonoscopes generally include a fiber optic imaging
bundle, illumination fibers, one or two instrument channels that
may also be used for insufflation or irrigation, and a suction
channel that extends the length of the colonoscope to facilitate
removal of occlusions such as mucus, plaque, fecal matter, or other
material that can obstruct the physician's view or interfere with
the endoscopic procedure. The colonoscope is inserted via the
patient's anus and is advanced through the colon, allowing direct
visual examination of the colon, the ileocecal valve, and portions
of the terminal ileum. Approximately six million colonoscopies are
performed each year.
In order to examine a patient's anatomy during a colonoscopy, it is
essential to have a clear field of view. Currently, about 20% of
colon polyps are undetected due to low visibility, which can arise
from inadequate lens cleaning. Poor colon preparation is also a
cause of reduced visibility in the colon. Presently, about 10% of
all patients are non-compliant with preparatory procedures and
approximately 4% of all patients are unable to complete the exam
due to an excess of stool in the colon. The remaining 6% of all
cases are considered marginal, and the colonoscopy may still be
performed if the colon is evacuated as a part of the procedure.
Conventionally, the colons of marginal cases are cleared by
repeatedly administering several small (60 cc) fluid flushes
through an endoscope's working channel by means of an ancillary
apparatus that employs a low-volume wash and suction. The waste is
then removed through the suction channel in the endoscope. However,
this tedious and inefficient process is limited by the amount of
stool that can be removed with each flush. The process also causes
a loss of productivity due to the added time required to evacuate
the colon. Therefore, there is a need for a system and method of
efficiently cleaning poorly prepared colons.
One example of a colon irrigation method for colonoscopy is
described in U.S. Pat. No. 5,279,542, entitled "Colon Irrigation
Method." The '542 patent describes an irrigation instrument for use
in evacuating the colon prior to endoscopic surgery. The instrument
consists of an elongate tube with a plurality of longitudinally and
circumferentially spaced apertures along its entire length. A
pressurized source of irrigation fluid is connected to the tube for
feeding fluid through the channel and out through the apertures
with an essentially uniform radial distribution. The tube is thin
enough to fit down the biopsy channel of an endoscope. The
invention essentially provides an improved method for providing
irrigating fluid to a distal end of an endoscope or to a surgical
site.
Although the apparatus and method of the colon irrigation method
described in the '542 patent provides a means of irrigation for
colonoscopy and other endoscopic procedures, the device is an
accessory to standard endoscopes that uses the working channel of
the endoscope. As such, the apparatus requires labor-intensive
assembly on an as-needed basis. Furthermore, it is up to the
physician to determine the amount of cleaning that is required and
to control the apparatus such that the patient is sufficiently
prepped for an examination. This reduces the time that the
physician has to perform the actual examination.
Given these problems, there is a need for a system that can
automatically prepare poorly prepped patients for an endoscopic
examination with minimal physician supervision. In addition, the
system should operate based on the patient's individual physical
anatomy and detected level of cleanliness so that a desired field
of view is created in which an examination is conducted.
SUMMARY OF THE INVENTION
To address the foregoing deficiencies in the prior art, the present
invention is an endoscopic system that provides automated
irrigation and aspiration of patients undergoing colonoscopy. The
endoscopic examination system according to the present invention
includes an endoscope with a source of illuminative light and an
image sensor to produce images of a patient's colon. An image
processor is coupled to receive image signals from the image
sensor. The image processor or a computer automatically analyzes
the images obtained from the image sensor to determine if
irrigation and aspiration is required to provide a clear field of
view. If so, the computer operates one or more control valves that
supply the insufflation, irrigation, and aspiration to the
patient.
In one embodiment, the endoscope may include one or more sensors
that sense environmental conditions within the patient's colon such
that the amount, rate, or composition of the cleaning solution
delivered can be adjusted to the patient's individual anatomy and
level of preparation. In one embodiment, the level of insufflation
and aspiration are automatically adjusted to provide a desired
field of view in the region of the distal tip of the endoscope.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing aspects and many of the attendant advantages of this
invention will become more readily appreciated as the same become
better understood by reference to the following detailed
description, when taken in conjunction with the accompanying
drawings, wherein:
FIG. 1 illustrates a single-use endoscopic imaging system in
accordance with one embodiment of the present invention;
FIG. 2 is a functional block diagram that shows the
interrelationship of the major components of a single-use
endoscopic imaging system shown in FIG. 1;
FIG. 3 illustrates a distal end of a single-use imaging endoscope
in accordance with an embodiment of the present invention; and
FIGS. 4A and 4B illustrate an imaging sensor and heat exchanger
positioned at the distal end of the endoscope in accordance with an
embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
As indicated above, the present invention is an endoscopic
examination system that provides integrated and automated
irrigation and aspiration for prepping poorly prepared patients for
examination. The system is integral to the overall endoscope
architecture. Further, the physical hardware implementation of the
endoscope improves upon previous means of irrigation by the use of
an automated mechanism that administers one or more colon
irrigation modalities depending on an analysis of the patient's
anatomy or level of preparation. Although the present invention is
described with respect to its use within the colon, it will be
appreciated that the invention can be used in any body cavity that
can be expanded and/or prepared for examination or surgery.
FIG. 1 illustrates the major components of an exemplary single-use
endoscopic imaging system 10. The components of the system 10
include a display 12, a user input device 16, and a single-use
imaging endoscope 18, all of which are functionally connected to a
control cabinet 14 that executes application software (not shown)
residing therein. Display 12 is any special-purpose or conventional
computer display device, such as a computer monitor, that outputs
graphical images and/or text to a user. Single-use imaging
endoscope 18 is a single-use flexible tube that contains one or
more lumens for the purpose of performing endoscopic procedures and
facilitating the insertion and extraction of fluids, gases, and/or
medical devices into and out of the body. Single-use endoscope 18
further contains a digital imaging system (not shown) comprised of,
in one example, an image sensor such as a CMOS imager, optical
lenses such as plastic optics, a light source such as a number of
LEDs, and an articulating tip that enables steering of the
endoscope in a desired direction.
Control cabinet 14 is a special-purpose electronic and
electromechanical apparatus that processes and manages all system
functions, and includes a network-enabled image-processing CPU, a
physical connection to the single-use endoscope 18, an optional
dock for the user interface 16, and valves that control the
delivery of gas/water to the endoscope and a vacuum line that
removes the air/gas and debris, etc., from the patient. User input
device 16 is a hand-held device, either wired to the control
cabinet 14 or wireless, that accepts inputs from a human operator
via standard push buttons, joysticks, or other activation devices
either singularly or in combination to control the operation of
single-use endoscopic imaging system 10.
Operation of single-use endoscopic imaging system 10 is as follows:
the system is initiated and operated upon command by means of user
input device 16, causing the application software executed by a
processor within the control cabinet 14 to activate the appropriate
hardware to perform surgical, therapeutic, diagnostic, or other
medical procedures and to deliver insufflation and/or suction to
the lumen(s) of single-use endoscope 18. Display 12 provides live
endoscopic video images and visual feedback of control parameters
to the physician or operator so that an examination of the patient
can be completed. Upon termination of the examination, the
endoscope 18 is disconnected from the control cabinet and disposed
of.
FIG. 2 is a functional block diagram of single-use endoscopic
imaging system 10 that shows the operational interrelationship of
the major hardware and software elements of the system. A complete
description of the control cabinet 14 and other components is set
forth in U.S. patent application Ser. No. 10/811,781, filed Mar.
29, 2004, and U.S. patent application Ser. No. 10/956.007, entitled
VIDEO ENDOSCOPE, filed concurrently herewith) and herein
incorporated by reference. The single-use endoscopic imaging system
10 includes the control cabinet 14 that operates to control the
orientation and functions of a single-use imaging endoscope 18. The
control cabinet 14 includes a controller interface 106 that
receives commands from the user input device 16 such as a joystick,
that is used by a physician or their assistant to control the
operation of the single-use endoscope 18. Commands from the
joystick are supplied to a programmable processor such as a digital
signal processor that controls the overall operation of the imaging
system and a servo control unit 108. The processor and servo
control unit 108 control the operation of a pair of servo motors
110, 112 that in turn drive control cables within the single-use
endoscope 18. The orientation of the distal tip is controlled in
response to directional signals received from the user input device
as well as feedback signals obtained from sensors that measure the
position and torque of each of the servo motors 110, 112.
In one embodiment of the invention, the processor and servo control
unit 108 implement a position-to-rate control that varies the speed
at which the distal tip is moved as a function of the position of
the directional switch on the user input device 16. However, other
control algorithms such as position-to-position or
position-to-force (i.e., acceleration) could also be
implemented.
The control cabinet 14 also includes an imaging board 114 that
produces images from the signals that are received from the image
sensor at the distal end of the single-use endoscope 18. The
imaging board 114 deserializes the digital video signals from the
CMOS imager sensor and performs the necessary algorithms such as
demosaicing, gain control and white balance to produce a quality
color image. The gain control of the system is implemented by
adjusting the intensity of the illumination (current supplied to a
number of LEDs) and adjusting the RGB gains of the CMOS imager. The
imaging board 114 also includes isolation circuitry to prevent a
patient from becoming shocked in the event of an electrical failure
on the imaging board 114 or within the control cabinet 14 as well
as circuitry for transmitting control signals to the image sensor
and for receiving image signals from the image sensor. In one
embodiment of the invention, the imaging board 114 is provided on a
standard PC circuit board to allow individual endoscopes to be
tested with a personal computer and without the need for an
additional control cabinet 14.
In the embodiment shown in FIG. 2, the single-use endoscope 18 has
a distal shaft portion 120 that is connected to a breakout box 122
with a swivel connection 124. The breakout box 122 provides access
to a working channel in the distal portion of the endoscope. In
addition, the proximal portion 126 of the shaft is connected to the
breakout box 122 with a second swivel connection 128. The swivel
connections 124, 128 allow the distal and proximal ends of the
endoscope to rotate with respect to the breakout box 122 and
without twisting the breakout box 122 in the hands of the physician
or their assistant.
In the embodiment shown, the single-use endoscope 18 is connected
to the control cabinet 14 with a connector 130. Within the
connector 130 are a pair of spools 132, 134 that are engageable
with the driveshafts of the servo motors 110, 112. Each spool 132,
134 drives a pair of control cables that are wound in opposite
directions. One pair of control cables drives the distal tip of the
endoscope in the up and down direction, while the other pair of
control cables drives the distal tip of the endoscope in the left
and right direction. In an alternate embodiment, the endoscope may
include a manual handle having control knobs that selectively
tension or release the control cables to move the distal tip and
one or more buttons that activate functions of the endoscope.
The connector 130 also includes a manifold 140 that controls the
supply of irrigation fluid, air and vacuum to various tubes or
lumens within the endoscope 18. In addition, the connector 130
includes an electrical connector 142 that mates with the
corresponding electrical connector on the control cabinet 14. The
connector 142 transfers signals to and from the image sensor as
well as power to the illumination LEDs and allows connection to a
thermal sensor at the distal end of the endoscope. In addition, the
connector 142 carries signals from one or more remotely located
environmental sensors as will be described below. Water or another
irrigation liquid is supplied to the endoscope with a pump 145. The
pump 145 is preferably a peristaltic pump that moves the water
though a flexible tube that extends into the proximal connector
130. Peristaltic pumps are preferred because the pump components do
not need to come into contact with the water or other fluids within
the endoscope and it allows the wetted component to be single-use.
A water or other irrigation liquid reservoir 150 is connected to
the pump 145 and supplies water to cool the illumination LEDs as
well as to irrigate the patient. The water supplied to cool the
LEDs is returned to the reservoir 150 in a closed loop. Waste water
or other debris are removed from the patient with a vacuum line
that empties into a collection bottle 160. Control of the vacuum to
the collection bottle 160 is provided at the manifold 140 within
the proximal connector 130. A gas source provides insufflation by
delivering an inert gas such as carbon dioxide, nitrogen, air,
etc., to the lumen(s) of single-use endoscope 18 via the manifold
140.
The processor and control unit 108 executes application software,
including a GUI software application, a system control software
application, and a network software application that reside on a
computer readable medium such as a hard disc drive, CD-ROM, DVD,
etc., or in a solid state memory. GUI software application is well
known to those skilled in the art, and provides the physician or
operator with live endoscopic video or still images and,
optionally, with visual, audible, or haptic control and feedback on
display 12 using user input device 16. System control software
application is the central control program of application software
that receives input from sensors, such as from the one or more
environmental sensors at the distal end of the endoscope as
described below, as well as from the input device 16. System
control software application provides system control for the
functions necessary to operate single-use endoscope system 10. The
network software application operates a network connection to allow
the endoscopic imaging system 10 to be connected to a local area
network and/or the Internet.
As set forth in the 10/811,781 application, the manifold 140
supplies insufflation gas, water and vacuum to one or more lumens
of single-use endoscope 18. The manifold is preferably constructed
as a series of passages that are formed between sheets of a
thermoplastic material. Water, air, and vacuum are applied to
inputs of the manifold and selectively delivered to outputs that
are in turn connected to lumens within the endoscope 18 by pinch
valves on the control cabinet 14 that open or close the passages in
the manifold. The passages are preferably formed by rf welding the
sheets of thermoplastic into the desired pattern of the
passages.
In accordance with FIG. 2, the basic process of insufflation and
exsufflation using single-use endoscopic imaging system 10 is as
follows:
During operation, live endoscopic video images are provided on
display 12 by the GUI software application, which processes
information from the imaging board 114, and the single-use
endoscope 18. Prior to operation, insufflation is initiated upon
operator command by means of the user input device 16, or according
to a pre-programmed routine. As a result, system control software
application activates the manifold 140 by means of the pinch valves
on the control cabinet 14. Upon advancing single-use endoscope 18,
images are produced by the image sensor at the distal tip of the
endoscope and analyzed by the image processor 114 and/or the
processor and servo control unit 108 to determine if either
irrigation or insufflation is required. If insufflation is
required, an insufflation gas is channeled through a lumen of
single-use endoscope 18 and into the patient. In one embodiment of
the invention, the gas delivery lumen terminates at directional
port 256, that directs the insufflation gas and/or irrigation
liquid over a lens 270 of the imaging sensor, as shown in FIG. 3.
As the distal tip of single-use endoscope 18 is advanced into the
colon during the endoscopic procedure, further areas of the colon
are insufflated, bringing new examination regions into view.
As shown in FIG. 3, the distal end of the single-use endoscope 18
includes a distal cap 250 having a number of openings on its front
face. The openings include an opening to a working channel 252 and
an opening 254 for a low pressure lavage lumen, whereby a stream of
liquid can be delivered through the endoscope to remove debris or
obstructions from the patient. A lens wash and insufflation port
includes the integrated directional port or flush cap 256 that
directs water across the lens of an image sensor and delivers the
insufflation gas to expand the lumen in which the endoscope is
inserted. Offset from the longitudinal axis of the endoscope is a
lens port 258 that is surrounded by a pair of windows or lenses 260
and 262 that cover the illumination sources. One or more
environmental sensors 245 are also disposed on or adjacent the
front face of the distal cap 250 to detect environmental conditions
within the body cavity of the patient. Signals from the one or more
environmental sensors are transmitted back to the processor and
servo control unit 108 through the electrical connector 142.
Suitable environmental sensors 245 include, but are not limited to,
pressure, temperature, pH sensors to measure conditions in the
patient adjacent the distal tip. In addition, sensors such as laser
distance sensor or ultrasonic probes can be used to measure the
size of the area or thickness of the colon wall surrounding the
endoscope.
As best shown in FIG. 4A, the imaging assembly at the distal end of
the endoscope also includes a heat exchanger 280. The heat
exchanger 280 comprises a semi-circular section having a concave
recess 282 into which a cylindrical lens assembly 270 is fitted.
The concave recess 282 holds the position of the lens assembly 270
in directions perpendicular to the longitudinal axis of endoscope,
thereby only permitting the lens assembly 270 to move along the
longitudinal axis of the endoscope. Once the lens assembly is
positioned such that it is focused on an image sensor 290 that is
secured to a rear surface of the heat exchanger 280, the lens
assembly is fixed in the heat exchanger with an adhesive. A pair of
LEDs 282, 284 are bonded to a circuit board that is affixed in the
heat exchanger such that a channel is formed behind the circuit
board for the passage of a fluid or gas to cool the LEDs. A circuit
board or flex circuit 292 containing circuitry to transmit and
receive signals to and from the control cabinet is secured behind
the image sensor 290 and to the rear surface of the heat exchanger
280. With the lens assembly 270, the LEDs 280, 282, the image
sensor 290, and associated circuitry 292 secured in the heat
exchanger 280, the heat exchanger assembly can be fitted within the
distal cap 250 to complete the imaging assembly.
As discussed, the images obtained from the image sensor are
analyzed by an image analysis program to determine when cleaning of
the imaging system or the colon itself is desired. In addition,
measurements of the colon cavity obtained from the one or more
environmental sensors may be combined with image information as
analyzed by the image analysis program to control the supply of
irrigation and aspiration when a cleaning cycle is required.
The basic process of irrigation and aspiration for the purpose of
prepping a poorly prepared patient during a colonoscopy procedure
using the endoscopic imaging system 100 is as follows.
The GUI software application displays the live video or still
images produced by the imaging board 114 on the display 110. In
addition, an image analysis program that is executed by a processor
on the imaging board 114 or the processor and servo control unit
108 analyzes the image signals to determine if it is necessary to
employ a wash routine in the patient or to clean the lens of the
endoscope 18. If the image analysis program determines that a lens
cleaning or wash routine should be initiated, the control software
application activates one or more valves controlling the manifold
to deliver an irrigation liquid and vacuum aspiration to the
endoscope. The modality of the washing routine supplied can be
determined based on an analysis of the images produced as well as
volumetric, environmental or other measurements obtained by the one
or more environmental sensors 245 at the distal end of the
endoscope.
To determine if the field of view of the single-use endoscope 18 is
clear or obstructed, the image analysis program analyzes images of
the patient's body for the presence of obstructing matter within
the area of view or on the surface of imaging optics. For example,
the image analysis program determines if the position of an
obstruction changes with a change in probe position. If an
obstruction remains in the same place within an image despite
moving the endoscope, then the system control software initiates a
blast of cleaning solution over the surface of the imaging lens.
However, if the image appears to indicate that the patient has not
been properly prepped, then the system control software proceeds to
initiate one or more cleaning or washing routines.
In one embodiment of the invention, the presence of obstructing
material in the field of view is detected by the image analysis
program on the basis of the color or spectral reflectance of the
tissue being observed. Healthy colon tissue is typically
characterized by white or pinkish tissue. Therefore, the image
analysis program searches an image to determine the number of
pixels in the image that display the desired tissue color. If the
image contains too many dark or other colored pixels, the presence
of obstructing material is presumed. Of course, it will be
appreciated that the color of healthy, clean tissue can vary from
patient to patient. Therefore, the physician may be prompted to
direct the probe at a known portion of healthy, clean tissue to
calibrate the image analysis program prior to beginning the
colonoscopy.
In performing the washing routine, the system control software may
take into consideration measurements obtained from the one or more
environmental sensors 245 included in the single-use endoscope 18.
For example, measurements of the size of the colon cavity,
thickness of the colon wall, pressure within the colon, or other
factors such as temperature, pH, etc. can be obtained from the one
or more environmental sensors 245 and used to adjust the volume or
rate of delivery and/or aspiration of liquid supplied or the
composition of the washing liquid can be adjusted based on the
measurements obtained. Similarly, the environmental sensor 245
positioned along the length of the endoscope can measure the depth
of insertion of the distal tip of the endoscope.
With the endoscopic imaging system 10, any obstructions that
interfere with the endoscopic procedure are automatically detected.
Washing or lens cleaning routines are initiated upon command by the
system control software or may be initiated by an operator command
received via user interface 16. Wash routines may include, for
example, a continuous spray, a pulsating jet, and a large bolus
wash. Sequential mixtures of fluids or gases can be augmented with
aeration and/or additives. Additives are added into the irrigant
solution, either singularly or in combination, upon operator
command using user interface 16 or as directed by preprogrammed
wash routines or based on an analysis of signals produced from the
image sensor and/or the one or more environmental sensors 245. New
wash routines may be downloaded through network connection by means
of network software application. Alternatively, a user may also
manually define new irrigant mixes and/or wash routines by
recording a series of operator commands on user interface 16.
After irrigation, the resulting maceration is aspirated under
control of the system control software application, which activates
the manifold 140. The manifold 140 applies vacuum through a working
or aspiration channel of the single-use endoscope 18. At any time,
the physician or their assistant may manually interrupt the wash
routine or aspiration.
The endoscopic imaging system of the present invention also
determines if the body cavity is properly inflated. Such a
determination is made by measuring the pressure and/or analyzing
images obtained from the image sensor. If the body cavity is not
properly inflated, insufflation gas is delivered to the patient in
a manner that is adjusted for environmental conditions in the
patient. As with the washing mode, the insufflation gas can be
delivered in accordance with the detected pressure in the body
cavity, the size of the cavity, or until the image signals produced
by the image sensor indicate that the colon is inflated to produce
a desired field of view. Furthermore, the insufflation gas can be
adjusted in accordance with the sensed thickness of the colon wall
or other parameters that assure that insufflation gas is not
delivered too quickly so as to cause discomfort or potential injury
to the patient. By automatically controlling the insufflation of
the colon at the region of the distal tip a desired field of view
is provided and inadvertent collapse of the colon is prevented.
Furthermore, the physician can concentrate on performing the
procedure without having to manually control insufflation.
As will be appreciated, the automated irrigation and aspiration
features of the present invention reduce the need for the physician
to actively control the preparation of poorly prepared patients for
examination. Because obstructions and poor fields of view are
automatically detected and cleared, the physician can concentrate
on performing the required procedure. Furthermore, the evacuation
wash routines may be tailored to a patient's individual condition
as detected by the image analysis program and one or more sensors
122.
While the preferred embodiment of the invention has been
illustrated and described, it will be appreciated that various
changes can be made therein without departing from the scope of the
invention. For example, although the present invention is described
with respect to single use, disposable endoscopes, it will be
appreciated that the present invention is also applicable to
non-disposable, reusable endoscopes as well. It is therefore
intended that the scope of the invention be determined from the
following claims and equivalents thereof.
* * * * *