U.S. patent application number 15/002751 was filed with the patent office on 2016-05-19 for fluid delivery system for use with an endoscope.
This patent application is currently assigned to Boston Scientific Scimed, Inc.. The applicant listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to Michael S. BANIK, Dennis R. BOULAIS, David W. HOFFMAN, Eric LITSCHER, John P. O'CONNOR, Christopher ROWLAND, Vincent TURTURRO.
Application Number | 20160135669 15/002751 |
Document ID | / |
Family ID | 35530807 |
Filed Date | 2016-05-19 |
United States Patent
Application |
20160135669 |
Kind Code |
A1 |
BOULAIS; Dennis R. ; et
al. |
May 19, 2016 |
FLUID DELIVERY SYSTEM FOR USE WITH AN ENDOSCOPE
Abstract
A fluid delivery system for use with an endoscope. Certain
embodiments of the invention include a single, large fluid source
and pump installed upon an operator console, in combination with a
small fluid reservoir and pump installed within a proximal
connector of the imaging endoscope, multiple fluid sources that
feed a common fluid channel that are pressurized by a common pump,
multiple fluid sources that feed dedicated fluid channels that are
pressurized by dedicated pumps, and a small fluid reservoir and
pump installed within a handheld manual controller of the imaging
endoscope. The fluid delivery endoscopic systems of the present
invention provide the user with the flexibility of changing fluids
either in advance of a procedure or on-the-fly as needed, instead
of relying on fixed fluid sources only.
Inventors: |
BOULAIS; Dennis R.;
(Danielson, CT) ; BANIK; Michael S.; (Bolton,
MA) ; TURTURRO; Vincent; (Milton, GA) ;
ROWLAND; Christopher; (Hopkinton, MA) ; HOFFMAN;
David W.; (Concord, MA) ; O'CONNOR; John P.;
(Andover, MA) ; LITSCHER; Eric; (Hopkinton,
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: |
35530807 |
Appl. No.: |
15/002751 |
Filed: |
January 21, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13302394 |
Nov 22, 2011 |
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15002751 |
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11239644 |
Sep 29, 2005 |
8083671 |
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13302394 |
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60614868 |
Sep 30, 2004 |
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Current U.S.
Class: |
604/113 ;
604/121 |
Current CPC
Class: |
A61B 1/12 20130101; A61B
1/128 20130101; A61B 1/015 20130101; A61B 1/00068 20130101; A61M
39/225 20130101; A61B 1/00119 20130101; A61B 1/00128 20130101 |
International
Class: |
A61B 1/015 20060101
A61B001/015; A61B 1/00 20060101 A61B001/00; A61M 39/22 20060101
A61M039/22; A61B 1/12 20060101 A61B001/12 |
Claims
1-31. (canceled)
32. A connector for fluidly connecting a lumen in an endoscope to a
fluid source, the connector comprising: a passage configured to
retain liquid under pressure for delivery to a lumen in an
endoscope; a port fluidly connected to the passage; a valve
configured to fluidly connect the port to the fluid source, wherein
the valve is movable via an actuator; and a flexible tubing
configured to receive fluid from the fluid source and deliver fluid
under pressure to the passage.
33. The connector of claim 32, wherein the flexible tubing includes
a first end and a second end, each of the first end and the second
end being connected to a housing of the connector.
34. The connector of claim 33, wherein the flexible tubing is
configured to mate with a pump configured to pressurize fluid in
the flexible tubing.
35. The connector of claim 32, wherein the passage is fluidly
connected to a cooling port, the cooling port configured to be
continually open and supply liquid to the endoscope.
36. The connector of claim 32, wherein the connector is connected
to a proximal connector of the endoscope.
37. The connector of claim 36, wherein the passage is fluidly
connected to the lumen in the endoscope via a tube disposed within
the proximal connector.
38. The connector of claim 37, wherein the proximal connector
includes at least two fluid connections, the at least two fluid
connections configured to mate with the fluid source.
39. The connector of claim 38, wherein each of the at least two
fluid connections includes a retaining detent configured to engage
a cooperating member on the fluid reservoir.
40. The connector of claim 32, wherein the actuator is remote from
the endoscope.
41. A connector at a proximal end of a shaft for connecting the
proximal end of the shaft to a fluid reservoir, the connector
comprising: a passage configured to retain liquid under pressure; a
selectively closeable port fluidly connected to a lumen in the
shaft to receive fluid from the fluid reservoir, wherein the
selectively closeable port is associated with a valve configured to
selectively connect the lumen to the liquid under pressure retained
by the passage; an open port configured to continually deliver
liquid from the passage to the shaft; and a receiving port
configured to continually receive liquid from the shaft and supply
the liquid to the fluid reservoir.
42. The connector of claim 41, further comprising a flexible tubing
configured to receive fluid from the fluid reservoir and deliver
fluid to the passage.
43. The connector of claim 42, wherein the flexible tubing includes
a first end and a second end secured to the connector.
44. The connector of claim 43, wherein the flexible tubing is
configured to mate with a pump that pressurizes fluid in the
flexible tubing.
45. The connector of claim 42, wherein the passage includes a high
pressure bypass valve that opens to relieve pressure in the
passage.
46. The connector of claim 41, wherein the connector includes a
bolus wash bypass valve configured to divert liquid from the
passage away from a working channel lumen if the working channel is
not open.
47. The connector of claim 41, wherein the passage includes a
four-way port configured to connect a working channel of the
endoscope, a bolus wash port on the passage, a bolus wash bypass
port, and a vacuum port.
48. A connector at the proximal end of the shaft for connecting the
proximal end of the shaft to a fluid reservoir, the connector
comprising: a passage configured to retain liquid under pressure; a
selectively closeable port fluidly connected to the lumen in the
shaft to receive fluid from the fluid reservoir, wherein the
selectively closeable port is associated with a valve configured to
selectively connect the lumen to the liquid under pressure retained
by the passage; and a flexible tubing configured to receive fluid
from the fluid reservoir and deliver fluid to the passage.
49. The connector of claim 48, wherein the flexible tubing includes
a first end and a second end secured to the connector.
50. The connector of claim 49, wherein the flexible tubing is
configured to mate with a pump that pressurizes fluid in the
flexible tubing.
51. The connector of claim 48, wherein the passage includes a high
pressure bypass valve that opens to relieve pressure in the
passage.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims the benefit of U.S.
Provisional Application No. 60/614,868, filed Sep. 30, 2004.
FIELD OF THE INVENTION
[0002] The present invention relates to medical devices, in
general, and fluid delivery mechanisms for therapeutic and
diagnostic endoscopes, in particular.
BACKGROUND OF THE INVENTION
[0003] As an aid to the early detection of disease, it has become
well established that there are major public health benefits that
result from regular endoscopic examination of internal structures,
such as the alimentary canals and airways, e.g., the esophagus,
stomach, lungs, colon, uterus, ureter, kidney, and other organ
systems. A conventional imaging endoscope used for such procedures
is formed of a flexible tube that has a fiber optic light guide
that directs illuminating light from an external light source to
the distal tip, where it exits the endoscope and illuminates the
tissue to be examined. Frequently, additional optical components
are incorporated, in order to adjust the spread of light exiting
the fiber bundle at the distal tip. An objective lens and fiber
optic imaging light guide communicating with a camera at the
proximal end of the endoscope or an imaging camera chip installed
at the distal tip produces an image that is displayed to the
examiner. In addition, most endoscopes include one or more working
channels, through which medical devices, such as biopsy forceps,
snares, fulguration probes, and other tools, may be passed.
[0004] Navigating the endoscope through complex and tortuous paths
in a way that produces minimum pain, side effects, risk, or
sedation to the patient is critical to the success of the
examination. To this end, modern endoscopes include means for
deflecting the distal tip of the endoscope to follow the pathway of
the structure under examination, with minimum deflection or
friction force upon the surrounding tissue. By manipulating a set
of control knobs, the examiner is able to steer the endoscope
during insertion and direct it to a region of interest, in spite of
the limitations of such traditional control systems, which may be
clumsy, non-intuitive, and friction-limited.
[0005] In any endoscopic procedure, there is almost always a need
for the introduction and evacuation of different types of fluids,
such as water, saline, drugs, contrast material, dyes, or
emulsifiers. For example, one endoscopic procedure is a
colonoscopy, which is an internal examination of the colon by means
of an instrument called a colonoscope. In colonoscopy procedures,
typically, 5-10% of patients who arrive for the procedure are
inadequately prepared (i.e., the colon is not properly cleared) and
are, therefore, turned away. Some patients who are only marginally
unprepared can be fully prepared by a physician or their assistant
administering doses of liquid and aspirating the colon. However,
these procedures are made more difficult and time consuming because
it requires the physician to flush and evacuate stool or other
debris, which represents a loss of productivity.
[0006] Another endoscopic procedure is an
esophagogastroduodenoscopy (EGD), which is an examination of the
lining of the esophagus, stomach, and upper duodenum by means of an
endoscope that is inserted down the throat. During an EGD
procedure, the mixing of bile and water creates a lot of
captivating bubbles. These bubbles hinder the physician's
visibility during the procedure. As a result, a liquid is often
introduced to help reduce the bubbles and, thus, improve
visibility.
[0007] Yet another endoscopic procedure is an endoscopic retrograde
cholangiopancreatography (ERCP), which is an endoscopic procedure
used to identify stones, tumors, or narrowing in the bile ducts. In
an ERCP procedure, fluids are used to flush away bleeding from
sites. In addition, it is sometimes helpful to introduce dyes for
providing contrast to the site. Contrast material, or contrast dye,
is a substance used to make specific organs, blood vessels, or
types of tissue (such as tumors) more visible on X-rays. Common
contrast material substances include iodine, barium, and
gadolinium.
[0008] Conventional endoscopes allow the introduction of liquids
via a separate delivery device, such as a syringe or injection
catheter that is passed through its working channel, in order to
deliver the liquid to the distal tip of the endoscope to the target
site within a patient's body. This liquid delivery method involves
several steps that include, for example, the user selecting a large
capacity syringe (e.g., up to 100cc), the user pouring a desired
liquid into a bowl, the user drawing the liquid into the syringe,
the user attaching the syringe to the working channel of the
endoscope, and the user squeezing the liquid out of the syringe.
This cumbersome and time-consuming process is repeated for any and
all types of liquids required in any given endoscopic
procedure.
[0009] To overcome these and other problems, there is a need for an
endoscope having a simplified way to introduce one or more liquids,
such as water, saline, drugs, contrast material, dyes, or
emulsifiers, that are used in endoscopic procedures, such as a
colonoscopy procedure, an EGD procedure, or an ERCP procedure, etc.
The endoscopic system should have improved simplicity and ease of
use, increased efficiency, and greater clinical productivity and
patient throughput. Furthermore, there is a need for improved
control of the delivery rate of a liquid and improved mechanisms
for mixing two or more fluids. Finally, there is a need for an
endoscope that can deliver one or more liquids during a procedure
and be inexpensive enough to manufacture that the device can be
disposable.
SUMMARY OF THE INVENTION
[0010] The present invention is a fluid delivery system for use
with an endoscope. The fluid delivery system includes an imaging
endoscope that may be used in combination with multiple fluid
delivery mechanisms. In one embodiment, the imaging endoscope may
be designed such that it is sufficiently inexpensive to
manufacture, such that it may be considered a single-use,
disposable item.
[0011] Certain embodiments of the invention include a single, large
fluid source and pump installed upon a reusable operator console in
combination with a small, fluid reservoir and pump installed within
a proximal connector of the imaging endoscope. Other embodiments of
the invention include multiple fluid sources that feed a common
fluid channel and that are pressurized by a common pump. Yet other
embodiments of the invention include multiple fluid sources that
feed dedicated fluid channels that are pressurized by dedicated
pumps, respectively. Yet other embodiments of the invention include
a small, fluid reservoir and pump installed within a handheld
manual controller of the imaging endoscope. The multi-fluid
endoscopic systems of the present invention provide the user with
the flexibility of changing fluids either in advance of a procedure
or on-the-fly as needed, instead of relying on fixed fluid sources
only. Furthermore, the arrangement of fluid sources, pumps and
valves within the multi-fluid endoscopic systems of the present
invention provide a controlled fluid delivery rate and a controlled
way of mixing fluids.
[0012] In yet another embodiment of the invention, the endoscope
includes a proximal connector, including a manifold that delivers a
fluid to one or more lumens in the endoscope. Valve spools are
selectively actuated to deliver a pressurized liquid to one or more
of its lumens.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] 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:
[0014] FIG. 1 illustrates a perspective view of a multi-fluid
endoscopic system in accordance with an embodiment of the
invention;
[0015] FIG. 2 illustrates a side view of an endoscope proximal
connector in accordance with an embodiment of the invention;
[0016] FIG. 3 illustrates a flow diagram of an exemplary method of
using a multi-fluid endoscopic system of the present invention
during a colonoscopy procedure;
[0017] FIG. 4 illustrates a perspective view of a multi-fluid
endoscopic system in accordance with another embodiment of the
invention;
[0018] FIG. 5 illustrates a perspective view of a multi-fluid
endoscopic system in accordance with another embodiment of the
invention;
[0019] FIG. 6 illustrates a perspective view of a handheld manual
controller that includes a local fluid reservoir in accordance with
an embodiment of the invention;
[0020] FIG. 7 illustrates a top view of the integrated fluid
reservoir that is installed, optionally, within the handheld manual
controller of FIG. 6 in accordance with an embodiment of the
invention;
[0021] FIG. 8 illustrates a single use endoscope having a proximal
connector positioned on a reusable control unit in accordance with
one embodiment of the present invention;
[0022] FIGS. 9A and 9B illustrate further details of a proximal
connector;
[0023] FIG. 9C illustrates a rear surface of a proximal connector
in accordance with an embodiment of the present invention;
[0024] FIG. 10A is a cutaway view of the proximal connector in
accordance with an embodiment of the present invention;
[0025] FIG. 10B illustrates a circuit board retaining feature of
the proximal connector in accordance with an embodiment of the
present invention;
[0026] FIGS. 11A and 11B illustrate a manifold within the proximal
connector in accordance with an embodiment of the present
invention;
[0027] FIG. 12 illustrates a valve spool within a manifold in
accordance with an embodiment of the present invention;
[0028] FIGS. 13A and 13B illustrate a vacuum line and valve within
a manifold in accordance with an embodiment of the present
invention; and
[0029] FIG. 14 illustrates a pressure relief valve within a
manifold in accordance with an embodiment of the present
invention.
DETAILED DESCRIPTION
[0030] FIG. 1 illustrates a perspective view of an endoscopic
system 100 in accordance with a first embodiment of the invention.
The endoscopic system 100 includes an imaging endoscope 110 that
further includes an endoscope proximal shaft 112 that is
electrically, mechanically, and fluidly connected, at one end, to
an endoscope proximal connector 114 and, at an opposite end, to a
port of a handheld manual controller 116, and an endoscope distal
shaft 118 that is electrically, mechanically, and fluidly
connected, at one end, to another port of handheld manual
controller 116 and that has an endoscope distal tip 120 located at
its opposite end for advancing into a patient's body.
[0031] Imaging endoscope 110 is an instrument that allows for the
examination of the interior of a tract, lumen or vessel or hollow
organ of a patient. Imaging endoscope 110 further includes an
illumination mechanism (not shown), an image sensor (not shown),
and an elongate shaft that has one or more lumens located therein.
Imaging endoscope 110 may be sufficiently inexpensive to
manufacture, such that it is considered a single-use, disposable
item, such as is described in reference to U.S. patent application
Ser. No. 10/406,149 filed Apr. 1, 2003, Ser. No. 10/811,781, filed
Mar. 29, 2004, and Ser. No. 10/956,007, filed Sep. 30, 2004, all
assigned to Scimed Life Systems, Inc./Boston Scientific Scimed,
Inc., which are incorporated herein by reference. The referenced
patent applications describe an endoscope imaging system that
includes a reusable control cabinet that has a number of actuators
or a manually operated handle on the endoscope that controls the
orientation of an endoscope that is connectable thereto. The
endoscope is used with a single patient and is then disposed. The
endoscope includes an illumination mechanism, an image sensor, and
an elongate shaft that has one or more lumens located therein. An
articulation joint at the distal end of the endoscope allows the
distal end to be oriented by the actuators in the control cabinet
or by manual control.
[0032] The endoscopic system 100 further includes an operator
console 122 that is electrically connected to standard I/O devices,
such as a video display (not shown) and a keyboard (not shown). A
fluid source 124 is fluidly connected to the endoscope proximal
connector 114 of imaging endoscope 110 via a length of tubing 126
that passes through a pump 128. Fluid source 124 serves as a
reservoir that contains a supply of liquid, such as water or
saline, for use during a medical procedure. Fluid source 124 may
take the form of a rigid vessel or a bladder with a capacity of,
for example, up to one liter of fluid. Fluid source 124 may be a
refillable vessel, or alternatively, fluid source 124 is
sufficiently inexpensive to manufacture, such that it is considered
a single-use, disposable item. Tubing 126 is a length of any
standard flexible tubing, for example, 1/4-inch tubing, which is
also sufficiently inexpensive to manufacture, such that it is
considered a single-use, disposable item. Pump 128 is, for example,
a standard peristaltic pump, that is used to withdraw liquid from
fluid source 124 on demand. A peristaltic pump works by means of
rollers on rotating arms that pinch the flexible tubing against an
arc and, thus, move the fluid along. Pump 128 is capable of
delivering, for example, up to 50 pounds/square inch (PSI) of
pressure for a flow rate of, for example, 500 ml/min.
[0033] In one embodiment, the endoscope proximal connector 114 of
imaging endoscope 110 is electrically and mechanically connected to
the exterior of operator console 122, as shown in FIG. 1, via a
quick-release mechanism for making and breaking all electrical,
mechanical, and fluid/air/vacuum connections. The quick-release
mechanism allows endoscope proximal connector 114 to be secured
easily to the exterior of operator console 122. Endoscope proximal
connector 114 includes wires and tubes that pass through endoscope
proximal shaft 112, then through a handheld manual controller 116,
then through endoscope distal shaft 118, and then to endoscope
distal tip 120. Additionally, mounted within endoscope proximal
connector 114 is a fluid reservoir 130 that has an associated pump
(not shown) mounted within operator console 122. Endoscope proximal
connector 114 and fluid reservoir 130 are described in more detail
in reference to FIG. 2.
[0034] Endoscope proximal shaft 112 and endoscope distal shaft 118
are formed of a suitably lightweight, flexible material, such as
polyurethane or other biocompatible materials. Endoscope proximal
shaft 112 and endoscope distal shaft 118 are elongated shafts that
have one or more lumens located therein and wiring located therein
to support, for example, a working channel, a jet wash mechanism,
an illumination mechanism, and an image sensor that are located at
endoscope distal tip 120. Also included within handheld manual
controller 116 and endoscope distal shaft 118 are the electrical
and mechanical mechanisms for articulating endoscope distal tip 120
for advancing into a patient.
[0035] Handheld manual controller 116 of imaging endoscope 110 is a
handheld device that is electrically and mechanically connected to
operator console 122. Handheld manual controller 16 accepts inputs
from a human operator via standard push buttons, rotary knobs,
joysticks, or other activation devices, either singularly or in
combination, to control the operation of imaging endoscope 110,
which includes the delivery of pressurized liquid from fluid source
124. Alternatively, a user input device such as a keyboard or other
user interface located remotely from the endoscope may accept
inputs from a human operator to control the operation of the
imaging endoscope 110, including the delivery of pressurized liquid
from fluid source 124.
[0036] Operator console 122 is a special-purpose electronic and
electromechanical apparatus that facilitates, processes, and
manages all functions of multi-fluid endoscopic system 100.
Operator console 122 is loaded with software for managing, for
example, the operation of imaging endoscope 110 and its associated
imaging electronics (not shown) in order to create and/or transfer
images received from an image sensor within imaging endoscope 110
to the video display for viewing by a user. Operator console 122
further manages the operation of all pumps, such as pump 128.
[0037] FIG. 2 illustrates a side view of an exemplary endoscope
proximal connector 114 in accordance with an embodiment of the
present invention. Endoscope proximal connector 114 includes a
proximal connector housing 210 that is formed of a suitably
lightweight, rigid material, such as molded plastic. An end of
tubing 126, which is a single fluid channel, is split into an
arrangement of multiple fluid channels 212, for example, a fluid
channel 212a, 212b, 212c, and 212d. Fluid channels 212a, 212b,
212c, and 212d are fed separately into and along the full length of
endoscope proximal shaft 112 to endoscope distal tip 120.
[0038] Fluid channels 212a, 212b, 212c, and 212d are used, for
example, for supplying fluid, such as water, from fluid source 124
via pump 128 for (1) cooling light-emitting diodes (LEDs) (i.e.,
the illumination mechanism), (2) supplying a low pressure bolus
wash, (3) supplying a high pressure jet wash, and (4) supplying a
lens wash, all of which are located at endoscope distal tip 120.
Multiple fluid channels 212 are controlled via multiple respective
pinch valves 214. More specifically, fluid channels 212a, 212b,
212c, and 212d are controlled via pinch valves 214a, 214b, 214c,
and 214d, respectively. Pinch valves 214 are standard valves,
within which the flexible tubing of fluid channels 212 is pinched
between one or more moving external elements, in order to stop the
flow of fluid.
[0039] FIG. 2 also shows fluid reservoir 130 fitted into a recessed
cavity 216 within endoscope proximal connector 114. Fluid reservoir
130 is fluidly connected to a fluid channel 218 that is fed into
and along the full length of endoscope proximal shaft 112 and
delivers the fluid from fluid reservoir 130 to endoscope distal tip
120. The flow of fluid is controlled by a pinch valve 220 that is
identical to pinch valves 214. Fluid reservoir 130 is in the form
of, for example, a disposable, soft, flexible bag or bladder that
is easily detachable from fluid channel 218. The capacity of liquid
held within fluid reservoir 130 is relatively small, compared with
the capacity of fluid source 124. Fluid reservoir 130 may be sized,
for example, to hold a small quantity of irrigation liquids,
contrast media, medication, or dyes for marking tissue. An access
door (not shown) may be included within proximal connector housing
210 for installing or removing fluid reservoir 130 as needed
before, after, or during a medical procedure. The liquid within
fluid reservoir 130 may be pressurized with any well-known
mechanisms, such as a piston (not shown) that pushes against the
bladder that forms fluid reservoir 130. Additionally, electrical
wires (not shown) pass through endoscope proximal connector 114
between handheld manual controller 116 and operator console 122 for
controlling the flow of fluids via the combined functions of pinch
valves 214a, 214b, 214c, or 214d and pump 128 and/or pinch valve
220 and the pressurizing mechanism of fluid reservoir 130.
[0040] In operation, and with continuing reference to FIGS. 1 and
2, pressurized fluids from fluid source 124 and/or fluid reservoir
130 are delivered along the full length of endoscope proximal shaft
112 to endoscope distal tip 120, on demand, under the control of
electronics located within operator console 122. More specifically,
pump 128 and the pressurizing mechanism of fluid reservoir 130 are
activated, and the user controls the on-demand delivery of fluid,
for example, to supply a low pressure bolus wash via the working
channel of imaging endoscope 110, to supply a high pressure jet
wash at endoscope distal tip 120, or to supply a lens wash at
endoscope distal tip 120, all via push buttons on handheld manual
controller 116 that control pinch valves 214a, 214b, 214c, or 214d.
Additionally, the user controls the on-demand delivery of fluid
from fluid reservoir 130 via a push button on handheld manual
controller 116 that controls pinch valve 220 and the pressurizing
mechanism (not shown) of fluid reservoir 130, for example, to
deliver medication or dye through endoscope distal shaft 118 of
imaging endoscope 110 and out of endoscope distal tip 120 to a
tissue site within the patient. Pressurized fluids from fluid
source 124 and/or fluid reservoir 130 may be delivered continuously
to the endoscope distal tip 120 to supply cooling to the LEDs.
[0041] FIG. 3 illustrates a flow diagram of an exemplary method 300
of using multi-fluid endoscopic system 100 to handle a poorly
prepared patient during a colonoscopy procedure in accordance with
the invention. Method 300 and multi-fluid endoscopic system 100 are
not limited to a colonoscopy procedure. Those skilled in the art
will recognize that the method steps of method 300 may be adapted
easily to apply to any of the various medical procedures that use
various types of fluid sources, respectively. Method 300 includes
the steps of:
[0042] Step 310: Preparing the Patient
[0043] In this step, in a predetermined time period prior to the
time of the colonoscopy procedure, a patient consumes a quantity
of, for example, a phosphosoda solution or a colyte solution, which
serves as a laxative to flush stool out of the patient's colon.
Alternatively, the patient arrives with no or insufficient
preparation and the physician manually clears the patient's colon
with a colon preparation endoscope. Method 300 proceeds to step
312.
[0044] Step 312: Connecting Imaging Endoscope to Operator
Console
[0045] In this step, a user, which may be a physician, nurse, or
other assistant, attaches endoscope proximal connector 114 of
imaging endoscope 110 to the side of operator console 122 and
thereby makes all electrical and fluid connections to operator
console 122. The user activates operator console 122. Method 300
proceeds to step 314.
[0046] Step 314: Mounting Fluid Source and Activating Operator
Console
[0047] In this step, a user mounts fluid source 124 to operator
console 122 and, subsequently, connects tubing 126, at one end, to
the outlet of fluid source 124 and, at the opposite end, to a port
of endoscope proximal connector 114, while, at the same time,
passing a portion of tubing 126 within pump 128. The user then
activates operator console 122. Method 300 proceeds to step
316.
[0048] Step 316: Selecting and Mounting Fluid Reservoir
[0049] In this step, a user selects a fluid reservoir 130 that
contains the type of liquid required for the medical procedure,
such as a bowel softener in the case of a colonoscopy procedure
and, subsequently, mounts fluid reservoir 130 within cavity 216 of
endoscope proximal connector 114. Method 300 proceeds to step
318.
[0050] Step 318: Intubating the Patient
[0051] In this step, under the control of operator console 122 and
by using the controls of handheld manual controller 116, the
physician intubates the patient, by introducing and advancing
endoscope distal tip 120 of imaging endoscope 110 into a body
cavity of the patient, until such time that the area of the colon
to be cleared may be visualized upon video display of operator
console 22. Method 300 proceeds to step 320.
[0052] Step 320: Flushing the Colon
[0053] In this step, under the control of operator console 122 and
by using the controls of handheld manual controller 116, the user
alternately flushes and aspirates the patient's colon, by
alternately activating the bolus wash and/or jet wash function and
a suction function of multi-fluid endoscopic system 100. In doing
so, the user controls the activation of pump 128, one or more pinch
valves 214, and a suction/vacuum source (not shown) via the
controls of handheld manual controller 116. Method 300 proceeds to
step 322.
[0054] Step 322: Is Colon Clear?
[0055] In this decision step, the user visualizes the colon by
using the imaging electronics at endoscope distal tip 120, in
combination with the video display of operator console 122, to
determine whether the bolus wash and/or jet wash of step 320 is
effective in breaking down the stool in the patient's colon and,
thus, renders the colon clear. If yes, method 300 proceeds to step
326. If no, method 300 proceeds to step 324.
[0056] Step 324: Injecting Bowel Softener
[0057] In this step, under the control of operator console 122 and
by using the controls of handheld manual controller 116, the user
injects a bowel softener to help emulsify the stool by controlling
pinch valve 220, such that the bowel softener within fluid
reservoir 130 that is mounted within endoscope proximal connector
114 is released and, thus, passes into the patient's colon via
fluid channel 218 of endoscope proximal shaft 112. Method 300
returns to step 320.
[0058] Step 326: Completing the Colonoscopy Procedure
[0059] In this step, under the control of operator console 122 and
by using the controls of handheld manual controller 116, the user
completes the colonoscopy procedure which may include such steps as
selecting another type of liquid for installing into fluid
reservoir 130 within cavity 216 of endoscope proximal connector
114. Such fluids include, for example, an India ink for marking a
tissue site. Method 300 then ends.
[0060] FIG. 4 illustrates a perspective view of a multi-fluid
endoscopic system 400 in accordance with a second embodiment of the
invention. Multi-fluid endoscopic system 400 includes imaging
endoscope 110 that is connected to operator console 122 via
endoscope proximal connector 114, as described in reference to
FIGS. 1 and 2. Multi-fluid endoscopic system 400 includes pump 128,
as described in reference to FIG. 1. Multi-fluid endoscopic system
400 further includes a plurality of fluid sources 410, e.g., a
fluid source 410a, 410b, and 410c, that feed tubing 126 via a
tubing subassembly 412 that brings together the tubing from the
separate fluid sources 410 to a common line, i.e., tubing 126, and
wherein each fluid source 410 has an associated pinch valve that
allows liquid to reach the pump 128. Each fluid source 410 may take
the form of a rigid vessel or a bladder with a capacity of, for
example, up to one liter of fluid. Each fluid source 410 may be a
refillable vessel, or alternatively, each fluid source 410 is
sufficiently inexpensive to manufacture, such that it is considered
a single-use, disposable item.
[0061] In operation and with reference to FIG. 4, pressurized
fluids are delivered along the full length of endoscope proximal
shaft 112 to endoscope distal tip 120 on demand, under the control
of electronics located within operator console 122, in similar
fashion as described in reference to the endoscopic system 100 of
FIG. 1. However, the inclusion of multiple fluid sources 410 in the
endoscopic system 100 allows multiple fluid types, such as saline,
irrigation liquids, medication, or dyes, to be delivered, singly or
mixed with one another, to imaging endoscope 110, under the control
of operator console 122 and in combination with handheld manual
controller 116 for controlling pump 128 and the pinch valves of
tubing sub-assembly 412. Furthermore, endoscope proximal connector
114 may include multiple fluid channels 212 and fluid reservoir
130, as described in reference to FIG. 2 or, optionally, may
include a greater or lesser number of fluid channels 212 and not
include fluid reservoir 130.
[0062] FIG. 5 illustrates a perspective view of a multi-fluid
endoscopic system 500 in accordance with a third embodiment of the
invention. Multi-fluid endoscopic system 500 includes imaging
endoscope 110 that is connected to operator console 122 via
endoscope proximal connector 114, as described in reference to
FIGS. 1 and 2. Multi-fluid endoscopic system 400 also includes
multiple fluid sources 410, e.g., fluid source 410a, 410b, and
410c, as described in reference to FIG. 4. However, instead of
including tubing sub-assembly 412, each fluid source 410 has its
own dedicated length of tubing 126 and dedicated pump 128 that feed
endoscope proximal connector 114 of imaging endoscope 110. For
example, fluid source 410a is fluidly connected to endoscope
proximal connector 114 via a length of tubing 126a that passes
through pump 128a, fluid source 410b is fluidly connected to
endoscope proximal connector 114 via a length of tubing 126b that
passes through pump 128b, and fluid source 410c is fluidly
connected to endoscope proximal connector 114 via a length of
tubing 126c that passes through pump 128b, as shown in FIG. 5. Each
fluid source 410, therefore, has its own dedicated fluid channel
212 and pinch valve 214 within endoscope proximal connector 114.
The dedicated fluid channels 212 pass along the full length of
endoscope proximal shaft 112 to endoscope distal tip 120.
[0063] In operation and with reference to FIG. 5, pressurized
fluids are delivered along the full length of endoscope proximal
shaft 112 to endoscope distal tip 120 on demand, under the control
of electronics located within operator console 122, in similar
fashion as described in reference to multi-fluid endoscopic system
100 of FIG. 1. However, the inclusion of multiple fluid sources 410
in multi-fluid endoscopic system 100 allows multiple fluid types,
such saline, irrigation liquids, medication, or dyes, to be
delivered via a dedicated fluid channel 212 to imaging endoscope
110, under the control of operator console 122, in combination with
handheld manual controller 116, for controlling pumps 128a, 128b,
and 128c and associated pinch valves 214a, 214b, and 214c within
endoscope proximal connector 114. Optionally, endoscope proximal
connector 114 may not include fluid reservoir 130.
[0064] FIG. 6 illustrates a perspective view of handheld manual
controller 116 that includes a local fluid reservoir in accordance
with another embodiment of the invention. FIG. 6 shows that
handheld manual controller 116 includes a controller housing 610
formed of a suitably lightweight, rigid material, such as molded
plastic. Controller housing 610 is electrically, mechanically, and
fluidly connected, at one end, to endoscope proximal shaft 112 and,
at an opposite end, to endoscope distal shaft 118. Mounted within
controller housing 610 of handheld manual controller 116 are a
plurality of control buttons 612 that allow the physician to
manipulate the functions of the endoscope, such as taking a
picture, activating light, activating water, activating air, or
activating suction at endoscope distal tip 120. A plurality of
rotary knobs 614 control the articulation of endoscope distal tip
120 for advancing into the patient, and a working channel access
port 616 allows the insertion of a therapeutic or diagnostic
instrument into the working channel of endoscope distal shaft
118.
[0065] In the example shown in FIG. 6, handheld manual controller
116 provides an alternative to having a fluid reservoir located
within endoscope proximal connector 114, such as fluid reservoir
130, as described in reference to FIGS. 1 and 2. In this example,
handheld manual controller 116 further includes an integrated fluid
reservoir 618 that has an associated fluid activation button 620,
which provides a conveniently located mechanism for activating the
delivery of fluid from integrated fluid reservoir 618. Integrated
fluid reservoir 618 is described in more detail in reference to
FIG. 7.
[0066] FIG. 7 illustrates a top view of an exemplary integrated
fluid reservoir 618 that is installed, optionally, within handheld
manual controller 116. Integrated fluid reservoir 618 includes a
fluid bladder 710 surrounded on at least two opposite sides by a
water bladder 712. The contacting surfaces between fluid bladder
710 and water bladder 712 are represented by a pressure interface
714. The combination of fluid bladder 710 and water bladder 712
that form integrated fluid reservoir 618 is installed into a
recessed cavity within controller housing 610 of handheld manual
controller 116.
[0067] Fluid bladder 710 is fluidly connected to a fluid channel
that is fed into and along the full length of endoscope proximal
shaft 112 to endoscope distal tip 120. Fluid bladder 710 is in the
form of a disposable, soft, flexible bladder that is easily
detachable from within controller housing 610. Integrated fluid
reservoir 618 includes a pinch valve 716 at the outlet of fluid
bladder 710 to control the flow of fluid therefrom. Water bladder
712 is also in the form of a soft, flexible bladder; however, water
bladder 712 is permanently installed within controller housing 610.
Integrated fluid reservoir 618 includes a pinch valve 718 at the
inlet/outlet of water bladder 712 to control the flow of fluid
therethrough.
[0068] The capacity of liquid held within fluid bladder 710 is
relatively small, compared with the capacity of fluid source 124 or
fluid sources 410. Fluid bladder 710 may be sized, for example, to
hold a small quantity of irrigation liquids, contrast media,
medication, or dyes for marking tissue. An access door (not shown)
may be included within controller housing 610 of handheld manual
controller 116 for installing or removing fluid bladder 710 as
needed before, after, or during a medical procedure.
[0069] Integrated fluid reservoir 618 takes advantage of the supply
of, for example, water passing through handheld manual controller
116 from, for example, fluid source 124 of the endoscopic system
100 or fluid sources 410 of the endoscopic systems 400 and 500.
More specifically, the flow of water is able to pass in or out of
water bladder 712 and, therefore, cause water bladder 712 to expand
or contract. When water bladder 712 is expanded, pressure is
created against fluid bladder 710 at the pressure interface 714. As
a result, a pressure mechanism is created, and pressurized fluid is
forced out of fluid bladder 710 and down the fluid channel of
endoscope distal shaft 118 and delivered to endoscope distal tip
120. In operation, the user activates the pressure mechanism
created by the combination of fluid bladder 710 and water bladder
712 via fluid activation button 620, which activates any associated
pump (not shown) and controls pinch valves 716 and 718 that enable
the flow of, for example, water into water bladder 712 and fluid
from fluid bladder 710.
[0070] Those skilled in the art will recognize that the method
steps of method 300 may be adapted easily to apply to any of the
various medical procedures that use various types of fluid sources,
such as shown in FIGS. 1 through 7. For example, fluid source 124,
fluid reservoir 130, fluid sources 410, and integrated fluid
reservoir 618, as described in reference to the endoscopic systems
100, 400, and 500 of the present invention, provide the user with
the flexibility of changing fluids either in advance of a procedure
or on-the-fly as needed, instead of relying on fixed fluid sources
only. Furthermore, the arrangement of fluid sources, pumps, and
valves within the endoscopic systems 100, 400, and 500 of the
present invention provide a controlled fluid delivery' rate and a
controlled way of mixing fluids.
[0071] FIG. 8 shows yet another alternative embodiment of a fluid
delivery system for an endoscope. An endoscopic system 100 includes
an imaging endoscope 110 having a handheld manual controller 116
that is used by the physician to operate the endoscope and to steer
the endoscope distal tip 120. The proximal end of the endoscope
includes a connector 800 that is releasably secured to a reusable
console 820. As will be described in further detail below, the
connector 800 supplies liquids to various lumens in the endoscope
in order to perform such functions as bolus wash, jet wash, lens
wash, as well as providing vacuum and insufflation. The connector
800 is fluidly coupled to a reservoir 810 including a liquid such
as water or saline for delivery to the patient. The connector 800
also includes a U-shaped loop of tubing 830 which engages the
rollers of a peristaltic pump 840 for providing fluid pressure to
the liquid in the reservoir 810 such that it can be selectively
delivered to the lumens of endoscope to perform the desired tasks.
The connector 800 is also connected via a tube to a vacuum
collection jar 850 that captures retrieved aspirated liquids,
debris, tissue samples, etc., from the endoscope.
[0072] FIGS. 9A and 9B illustrate further detail of one embodiment
of the proximal connector 800. In the example shown, the connector
800 is made from a molded housing having a front and rear half that
are joined to a molded fluid manifold. The connector 800 is
sufficiently inexpensive to manufacture such that it can be a
disposable item. However, the connector design could also be made
to withstand repeated disinfection procedures that are performed
with reusable endoscopes.
[0073] As shown in FIG. 9A, the proximal connector 800 includes a
pair of ports 860, 862 that receive water from and return water to
the fluid reservoir 810 shown in FIG. 8. The reservoir is secured
to the ports 860, 862 with a pair of retaining detents 870, 872
that engage cooperating elements on the reservoir. The proximal
connector 800 also includes one or more ergonomic hand grips 880
that facilitate the insertion and removal of the proximal connector
800 from the console 820. As shown in FIG. 9B, the proximal
connector 800 includes a vacuum port 890 that is connected by a
flexible tubing (not shown) to the vacuum collection jar 850. The
U-shaped tubing 830 receives fluid from the fluid input port 860
and delivers it under pressure to a fluid manifold tube (not shown)
within the connector.
[0074] The rear surface of the connector 800 is shown in FIG. 9C.
The rear surface includes one or more bosses 900, 902, 904 that are
received on corresponding guide pegs (not shown) on the console 820
in order to aid in the placement of the proximal connector on the
console. In addition, the proximal connector 800 also includes a
number of valve spools 910, 912, 914, 916 that are selectively
actuated by an electromagnetic, hydraulic, pneumatic, or other
actuator types in order to direct fluids within the manifold to
various lumens in the endoscope. An electrical connector 930 is
seated within an outwardly extending rim 932 on the rear surface of
the proximal connector 800. The connector 930 serves to connect
electrical components within the endoscope to a corresponding
electrical connector on the console.
[0075] FIG. 10A illustrates the internal components of the proximal
connector 800. The proximal connector includes a manifold 920
including a number of ports 922, 924, 926 that are activated by
valve spools to selectively deliver pressurized liquid to various
lumens of the endoscope. In the embodiment shown, the port 922
delivers liquid for the bolus wash in the endoscope, a port 924
delivers liquid for a lens wash and a port 926 delivers liquid for
a jet wash.
[0076] The proximal end of the endoscope shaft fits within a
receiving portion 940 of the proximal connector 800. The receiving
portion 940 includes a number of ribs 950 that retain the proximal
end of the shaft such that it cannot be easily pulled from the
connector 800. In one embodiment, the receiving portion includes an
anti-rotation boss 952 that extends through a hole in the endoscope
shaft such that the shaft cannot be rotated within the
connector.
[0077] A cover 960 is placed over the rear surface of electrical
connector 930 to secure the connector 930 with the rear surface of
the connector and to act as a splash guard. As is best shown in
FIG. 10B, the circuit board 930 is held to the rear surface of the
connector 800 behind a lip of the outwardly extending rim 932 on
the rear surface of the connector 800. The rim has an opening that
exposes the contacts on the connector and a lip that is sized to be
smaller than the connector 930. The cover 960 has an outwardly
extending rim 962 that fits within the rim 932 in order to compress
the circuit board against the inside surface of the outer rim 932
when the cover 960 is secured to the rear surface of the proximal
connector 800.
[0078] A series of molded channels 970 operate to guide the various
tubes or lumens in the endoscope to the ports 922, 924, and 926
that provide fluids to the endoscope as well as a tube that it is
connected to. A port 930 provides insufflation gas to the
endoscope.
[0079] The proximal connector 800 also includes a four-way port
980. The port 980 directs fluids and air/vacuum to various lumens
within the proximal connector 800. The port 980 includes a port 982
that is oriented generally in line with the endoscope and is
connected to a working channel lumen of the endoscope (not shown).
A port 984 extends in a direction perpendicular to the port 982 and
in the embodiment shown is connected via a tube (not shown) to the
port 922 that supplies water to the port 982 for a bolus wash.
[0080] A port 986 is generally in line with the port 982 and is
fluidly coupled by a tube (not shown) to a bolus wash overpressure
valve 990 as will be explained in further detail below. In
addition, the port 980 includes a fourth port (not shown)
positioned in line with the working channel and beneath the port
986 that is coupled by a tube (not shown) to a vacuum port (also
not shown).
[0081] FIG. 11A illustrates further detail of the manifold 920
within the proximal connector. In the embodiment shown, the
manifold is molded as a separate piece and is joined to front and
rear halves of the proximal connector 800. The manifold 920
includes a common tube 1000 which is fluidly connected to each of
the ports 922, 924 and 926. In addition, the tube 1000 includes a
port 1002 that continually delivers a cooling liquid through a
lumen to a heat exchanger (not shown) within the distal tip of the
endoscope in order to cool the illumination devices. In addition,
the manifold 920 includes a port 1004 which receives the cooling
liquid back from the heat exchanger and supplies it to the port 862
for return to the liquid reservoir.
[0082] FIG. 11B illustrates how the U-shaped flexible tubing 830 is
secured within two ports 832, 834 on the top of the manifold. The
port 832 is fluidly coupled to the port 860 that receives liquid
from the fluid reservoir. The port 834 is fluidly coupled to the
tube 1000 in the manifold 920. The tubing 830 is preferably made of
propylene or other flexible material that can be pressurized by the
rollers peristaltic pump 840 on the console 820.
[0083] FIG. 12 illustrates further detail of the valve spools
within the ports connected to the manifold. As indicated above, the
manifold includes a tube 1000 that contains a pressurized liquid to
deliver to each of the various ports. In each of the liquid ports,
for example, port 922, liquid within the tube 1000 flows through a
cylinder 1010 having an opening 1012 that fluidly connects the
cylinder 1010 with the tube 1000. The cylinder 1010 has a first
diameter in the space between the port 922 and the tube 1000 and a
larger diameter in a region 1016 occupying the remainder of the
cylinder. A generally cylindrical valve spool, such as valve spool
916, is slidably received within the cylinder 1010. The valve spool
includes a pair of O-rings 1018, 1020. The O-ring 1020 has a
smaller diameter that is received within the smaller diameter
section 1014 of the cylinder 1010. Moving the O-ring 1018 into the
smaller diameter section 1014 seals the port 922 from receiving
fluids from the tube 1000. Conversely, retracting the valve spool
in the cylinder 1010 creates a fluid path between the tube 1000 and
the port 922 when the O-ring 1018 is below the port 922 as shown in
FIG. 12. At the transition of the larger and smaller diameters of
the cylinder, the cylinder is chamfered at an area 1026 to prevent
the O-ring 1018 from becoming sheared as the valve spool assembly
is moved in and out of the cylinder 1010. In one embodiment of the
invention, the chamfer is set at approximately 30 degrees.
[0084] The valve spool also includes a notched section 1020 in
which a corresponding tab 1022 from the rear half of the proximal
connector is fitted thereby retaining the valve spool in the
manifold 920. Finally, the valve spool includes a stepped portion
1024 of a smaller diameter that allows the spool to be grasped by
an actuator to move the valve spool in and out of the cylinder
1010.
[0085] FIGS. 13A and 13B illustrate the vacuum valve assembly
within the manifold. The vacuum assembly includes a vacuum port
1050 that is connected by a tube (not shown) to a port on the
four-way port 980 that is generally in line with the working
channel lumen of the endoscope. The valve assembly includes a valve
spool 910 having a construction similar to that described above,
which is selectively moved by an actuator to provide fluid
communication between the vacuum port 1050 and the port 890 that is
coupled to the vacuum collection jar. FIG. 13A also shows the low
pressure bolus wash bypass port 990 that is fluidly connected to
the vacuum port 890. If a bolus wash is applied while the physician
has a tool in the working channel or while the working channel is
blocked, liquid supplied from the manifold will open a valve in the
low pressure bolus wash bypass port 990. By entering the bypass
port 990, the working channel is prevented from becoming
pressurized with a liquid that may splash onto a physician or their
assistant.
[0086] Further detail of the low pressure bolus wash bypass valve
is shown in FIG. 14. The bypass port 990 includes an insert 1060
that secures a ball valve 1070 and biasing spring 1080 in the port
990. The insert 1060 has a lip that mates with the surface of the
ball valve 1070 in the port 990 by virtue of pressure from the
spring 1080. Once the pressure of the bolus wash liquid in the port
990 overcomes the spring force of the spring 1080, the ball valve
1070 is opened thereby allowing passage of liquid through the
insert 1060 and port 990 to the vacuum port 890. Also shown in
FIGS. 13B and 14, the manifold also includes a high pressure bypass
valve including a ball valve 1100 and spring 1110 that operate to
relieve pressure in the manifold tube 1000. If pressure within the
tube 1000 exceeds the spring force of the spring 1110, ball valve
1100 is forced open thereby opening a fluid channel between the
manifold tube 1000 and the low pressure side of the tubing 830. In
some embodiments of the invention, it may be necessary to employ a
metal seating ring within the cylinder of the high pressure bypass
valve in order to provide proper mating seal between the cylinder
and the ball valve 1100.
[0087] As will be appreciated by those of ordinary skill in the
art, the present invention is not limited to the configurations of
endoscopic systems as described and shown in reference to FIGS. 1
through 15. For example, the present invention may be used with an
endoscope that is steered by actuators in the console in response
to commands received from a user input device such as a joystick or
other mechanism. Furthermore, the manifold 620 in the connector 800
may also be used to deliver liquid from alternate fluid source
either in the proximal connector or the endoscope such as is shown
in FIGS. 1 and 6. Those skilled in the art will appreciate that any
arrangement or combination of the fluid delivery mechanisms
disclosed herein or others are possible, without departing from the
scope of this invention.
* * * * *