Note: Descriptions are shown in the official language in which they were submitted.
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CATHETER WITH IMAGING ASSEMBLY AND CONSOLE WITH REFERENCE
LIBRARY AND RELATED METHODS THEREFOR
BACKGROUND
[0001] The present invention relates to catheters and particularly to imaging
catheter systems
having displaying console with reference materials.
[0002] Several medical procedures involve positioning a catheter, such as a
feeding tube or
endoscope, within a patient through the patient's nose, mouth, or other
opening. In many
procedures, accurately positioning the catheter is crucial to the success of
the procedure and/or to
the safety of the patient. For example, a nasogastric (NG) feeding tube may be
inserted through
the nose, past the throat, and down into the stomach, or past the stomach into
the small bowels of
the patient to deliver food to the patient via the tube. If the feeding tube
is mistakenly positioned
in the patient's lung, the feeding solution would be delivered to the
patient's lung causing critical
and possibly fatal results.
[0003] Accordingly, x-ray imaging devices and procedures have been used to
confirm accurate
positioning of a feeding tube, or other type of catheter, within a patient.
Specifically, x-ray
images are taken of the patient after a feeding tube has been initially
positioned within the
patient. The x-ray images are examined to determine whether the feeding tube
was properly
positioned or whether re-positioning is necessary. The x-ray imaging procedure
is repeated until
feeding tube has been properly positioned. X-ray imaging procedures, however,
are generally
expensive and time consuming. Additionally, because a patient often uses a
feeding tube for a
substantial length of time, the x-ray imaging procedures must be repeated
periodically to ensure
that the feeding tube has not moved or migrated.
SUMMARY
[0004] One or more aspects of the invention can involve a catheter having an
imaging assembly.
The catheter can be a feeding tube having an imaging assembly. In accordance
with an aspect of
the invention, an imaging catheter system can comprise an imaging catheter
including an imaging
assembly having an imaging device for generating imaging signals corresponding
to images of
anatomy of a patient. The imaging assembly transmits the imaging signals
generated by the
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imaging device. The system also includes a console adapted to receive the
imaging signals
transmitted by the imaging assembly and present images generated from the
imaging signals on a
display. The console is adapted to selectively present a reference menu on the
display including
menu items. The menu items correspond to reference materials comprising any
one or more of
photographs, video recordings, audio recordings, diagrams, animations, and
text. The materials
provides information about any one or more of anatomy, patient preparation,
imaging catheter
preparation, imaging catheter placement, imaging catheter operation, imaging
catheter features,
console preparation, console operation, console features, system operation,
system features,
contact information, help information, and support information. The console
can be further
configured to present the reference menu simultaneously with the images
generated from the
imaging signals on the display. The console is typically configured to present
a graphical user
interface on the display. For some cases, the display is a touchscreen display
adapted to present
icons for control of the system by touching the display. The console, in
further configurations,
can be configured to present the reference materials simultaneously with the
images generated
from the imaging signals on the display. In still further cases, each of the
reference materials is
preferably located in a directory having a name corresponding to the
corresponding reference
material. The display can be adapted to present the reference menu when a user
touches the
display twice during a preselected period. The period can be, for example,
within about one
second. Further, at least a portion of the reference material is read-only
and, in some cases, can
be modified by updating system software. The imaging catheter system can
comprise a feeding
tube assembly including a feeding tube for delivering enteral feeding liquid
to the patient, the
tube having an inlet and an outlet and a feeding passage extending between
said inlet and said
outlet, the imaging catheter being positioned adjacent the outlet for
generating imaging signals
corresponding to an alimentary canal of the patient, the imaging assembly
being sealed from the
feeding passage to inhibit enteral feeding liquid in the feeding passage from
entering the imaging
assembly. The system typically further comprises an interface cable connecting
the imaging
catheter to the console for use in transmitting the imaging signals generated
by the imaging
device to the console.
[0005] One or more aspects of the invention can be directed to an imaging
catheter system,
comprising a feeding tube having an inlet connectable to a source of feeding
fluid, an outlet
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distal from and fluidly connected to the inlet through a feeding passage, and
an imaging device
disposed proximate the outlet, the imaging device configured to generate and
transmit imaging
signals corresponding to an image of an anatomy of a patient; and a console
comprising a display
and memory having stored therein a plurality of reference materials selected
from the group
consisting of photographs, video recordings, audio recordings, diagrams,
animations, text, and
combinations thereof In some cases, each of the plurality of reference
materials can provide
information about at least one of anatomy, patient preparation, imaging
catheter preparation,
imaging catheter placement, imaging catheter operation, imaging catheter
features, console
preparation, console operation, console features, system operation, system
features, and contact
information. Preferably, the console is configured to receive the imaging
signals, present at least
a portion of at least one image corresponding to the imaging signals on the
display, and present a
reference menu on the display including menu items corresponding to at least
one of the
reference materials. The at least one of the plurality of reference materials
can include a
photograph showing an anatomical landmark. The anatomical landmark can be one
of a
bronchus, larynx, a tracheal ring, cardia, pyloric sphincter or pylorus,
cricoid cartilage, bronchial
split, esophageal junction, stomach folds, duodenal folds, and a pyloric
orifice.
[0006] In accordance with another aspect of the invention, a method of
operating a medical
system having a medical instrument including an imaging device for generating
imaging signals
corresponding to images of anatomy of a patient and a console adapted to
present images
generated from the imaging signals on a display comprises accessing reference
material on the
display. The material includes an image of exemplary anatomy indicative of
proper placement of
the medical instrument in the patient.
[0007] One or more aspects of the invention can be directed to a method of
facilitating use of a
feeding tube assembly. In one or more embodiments in accordance with such
aspects of the
invention, the method can comprise providing a feeding tube having an inlet
connectable to a
source of feeding fluid, an outlet distal from and fluidly connected to the
inlet through a feeding
passage, and an imaging device disposed proximate the outlet, the imaging
device configured to
generate and transmit imaging signals corresponding to an image of an anatomy
of a patient; and
providing a console comprising a display and memory having stored therein a
plurality of
reference materials selected from the group consisting of audiovisual data
such as videos, audio,
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and photographs, textual data such as diagrams, animations, and text, and
combinations thereof.
In accordance with some particular embodiments, each of said reference
material can provide
information about at least one of anatomy, patient preparation, imaging
catheter preparation,
imaging catheter placement, imaging catheter operation, imaging catheter
features, console
preparation, console operation, console features, system operation, system
features, and contact
information. In some cases, the console can be configured to receive the
imaging signals, present
at least a portion of at least one image corresponding to at least a portion
of the imaging signals
on the display, and present a reference menu on the display including menu
items corresponding
to at least one of the reference materials. In some cases, the console can be
configured to
simultaneously present on the display a photograph from the plurality of
reference materials and
a video image corresponding to the image signals from the imaging assembly,
wherein the
photograph provides a representative anatomical marker. The method, in
accordance with
further aspects of the invention, can comprise at least one of storing
additional reference
materials into the memory, removing at least one of the reference materials
from the memory,
and replacing the memory with an updated memory, the updated memory having
stored therein
an updated reference material. The method, in accordance with other further
cases, can comprise
receiving the console from a user; and after receiving the console, at least
one of storing
additional reference materials into the memory, removing at least one
reference materials from
the memory, and replacing the memory with an updated memory, the updated
memory having
stored therein at least one updated reference material.
[0008] In one aspect, an imaging catheter system generally comprises an
imaging catheter and a
console. The imaging catheter includes an elongate body having opposite first
and second ends.
An imaging assembly is at the first end of the elongate body and includes an
imaging device for
generating imaging signals indicative of images of anatomy of a subject. The
imaging assembly
is adapted to transmit the imaging signals generated by the imaging device. An
electronic
memory component has a predefined identifier of the imaging catheter written
thereon. The
console includes a display. The console is configured for receiving the
imaging signals from the
imaging assembly and displaying images generated from the imaging signals on
the display. The
console is configured to read the predefined identifier from the electronic
memory component.
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BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a schematic illustration showing a perspective view of an
imaging feeding tube
assembly, in accordance with one or more aspects of the invention;
[0010] FIG. 2 is schematic illustration showing a perspective view of the
feeding tube assembly
in FIG. 1, in accordance with one or more aspects of the invention;
[0011] FIG. 3 is a schematic illustration showing a side, elevational view of
an imaging feeding
tube system, including the imaging feeding tube assembly in FIG. 1, and
interface cable, and a
console, in accordance with one or more aspects of the invention;
[0012] FIG. 4A is schematic illustration showing a perspective view of a
console connector of
the feeding tube assembly in FIG. 1, showing internal components and including
feeding tube
segments of a feeding tube, in accordance with one or more aspects of the
invention;
[0013] FIG. 4B is a schematic illustration showing another embodiment of an
inlet adaptor for
the imaging feeding tube assembly, in accordance with one or more aspects of
the invention;
[0014] FIG. 5 is a schematic illustration showing an enlarged, fragmentary,
perspective view of a
distal end portion of the feeding tube assembly in FIG. 1, including an
exploded imaging
assembly, an imaging assembly connector, and a portion of the feeding tube, in
accordance with
one or more aspects of the invention;
[0015] FIG. 6 is a schematic illustration showing an enlarged cross section
view of the feeding
tube of the feeding tube assembly in FIG. 1, in accordance with one or more
aspects of the
invention;
[0016] FIG. 7 is a schematic illustration showing a top perspective view of a
flex circuit
assembly of the imaging assembly in FIG. 5, in a folded configuration, in
accordance with one or
more aspects of the invention;
[0017] FIG. 8 is a schematic illustration showing a bottom perspective view of
the flex circuit
assembly of the imaging assembly in FIG. 4, in the folded configuration, in
accordance with one
or more aspects of the invention;
[0018] FIG. 9 is a schematic illustration showing a fragmentary view of the
imaging assembly in
FIG. 5, in accordance with one or more aspects of the invention;
[0019] FIG. 10 is a schematic illustration showing a perspective view of a cap
of the imaging
assembly in FIG. 5, in accordance with one or more aspects of the invention;
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[0020] FIG. 11 is a block diagram of the flex circuit assembly in FIG. 7, in
accordance with one
or more aspects of the invention;
[0021] FIGS. 12 and 13 are circuit schematic illustrations of the flex circuit
embodiment in
FIG. 11, in accordance with one or more aspects of the invention;
[0022] FIG. 14 is a schematic illustration showing a top plan view of the flex
circuit assembly of
the imaging assembly in FIG. 7, in an unfolded configuration, in accordance
with one or more
aspects of the invention;
[0023] FIG. 15 is a schematic illustration showing a top view of a first
substrate of the flex
circuit assembly in FIG. 14, in accordance with one or more aspects of the
invention;
[0024] FIG. 16 is a block diagram of the flex circuit assembly, in accordance
with one or more
aspects of the invention;
[0025] FIG. 17 is a block diagram of the flex circuit assembly, in accordance
with one or more
aspects of the invention;
[0026] FIG. 18 is a block diagram of an exemplary feeding tube system, in
accordance with one
or more aspects of the invention;
[0027] FIG. 19 is a flow diagram showing an exemplary graphical user interface
screen flow, in
accordance with one or more aspects of the invention;
[0028] FIGS. 20-31 are schematic illustrations showing exemplary graphical
user interface
screens displayable by a console, in accordance with one or more aspects of
the invention;
[0029] FIG. 32A is a schematic illustration showing a perspective view of an
imaging feeding
tube assembly, in accordance with one or more aspects of the invention;
[0030] FIG. 32B is a schematic illustration showing an exploded perspective of
the imaging
feeding tube assembly in FIG. 32A, in accordance with one or more aspects of
the invention;
[0031] FIG. 33 is a schematic illustration showing a cross-sectional view of a
feeding tube of the
imaging feeding tube assembly in FIG. 32A, in accordance with one or more
aspects of the
invention;
[0032] FIG. 34 is a schematic illustration showing an exploded perspective
view of an imaging
assembly of the imaging feeding tube assembly in FIG. 32A, in accordance with
one or more
aspects of the invention;
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[0033] FIG. 35 is a schematic illustration showing a perspective view of a
rigid-flex circuit
assembly, in accordance with one or more aspects of the invention;
[0034] FIG. 36 is a schematic illustration showing a top plan view of a rigid-
flex circuit, in
accordance with one or more aspects of the invention;
[0035] FIG. 37 is a schematic illustration showing a side, elevational view of
a rigid-flex circuit,
in accordance with one or more aspects of the invention;
[0036] FIG. 38 is a schematic illustration showing a perspective view of an
imaging assembly
connector of the imaging feeding tube assembly in FIG. 32A, in accordance with
one or more
aspects of the invention;
[0037] FIG. 39 is a schematic illustration showing a perspective view of the
imaging assembly in
FIG. 34, with a housing removed therefrom to show internal components, in
accordance with one
or more aspects of the invention;
[0038] FIG. 40 is a schematic illustration showing a longitudinal section view
of the housing of
the imaging assembly in FIG. 34, in accordance with one or more aspects of the
invention;
[0039] FIG. 41 is a schematic illustration showing an imaging assembly, in
accordance with one
or more aspects of the invention;
[0040] FIG. 42 is a schematic illustration showing a cross-sectional view of a
console connector
of the imaging feeding tube assembly, in accordance with one or more aspects
of the invention;
[0041] FIG. 43 is a schematic illustration showing an interface cable, in
accordance with one or
more aspects of the invention;
[0042] FIG. 44 is a schematic illustration showing a perspective view of a
flex circuit assembly,
with a flex circuit in a folded configuration, in accordance with one or more
aspects of the
invention; and
[0043] FIG. 45 is a schematic illustration showing a perspective view of the
flex circuit in
FIG. 44 in an unfolded or flat configuration, in accordance with one or more
aspects of the
invention;
[0044] FIG. 46 is a schematic illustration showing a partial perspective view
of an imaging
catheter system in accordance with one or more aspects of the invention;
[0045] FIG. 47 is a schematic illustration showing a front elevation view of a
console of the
imaging catheter system in accordance with one or more aspects of the
invention;
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[0046] FIG. 48 is a schematic illustration including copies of photographs
showing exemplary
markers representative of incorrect and correct paths; and
[0047] FIGS. 49A-49C are copies of photographs of exemplary markers with FIG.
49A showing
a copy of a photograph of a bronchus, FIG. 49B showing a copy of a photograph
of a portion of a
stomach, and FIG. 49C showing a copy of a photograph of tracheal rings.
[0048] Corresponding reference characters indicate corresponding parts
throughout the drawings.
DETAILED DESCRIPTION
[0049] In another aspect, a feeding tube assembly generally comprises a
flexible feeding tube
having opposite first and second longitudinal ends, a longitudinal axis
extending between the
first and second longitudinal ends, and a feeding passage defined therein
extending along the
longitudinal axis between the first and second longitudinal ends. An inlet
adaptor is adjacent the
second longitudinal end of the tube in fluid communication with the feeding
passage. The inlet
adaptor is configured for fluid connection to a source of enteral feeding
liquid to fluidly connect
the source of enteral feeding liquid to the feeding passage. An imaging
assembly includes an
imaging device. The imaging assembly is configured for generating and
transmitting imaging
signals indicative of images of the alimentary canal of a subject. The imaging
assembly is
secured to the tube adjacent the first longitudinal end of the tube and is
sealed from the feeding
passage to inhibit enteral feeding liquid in the feeding passage from entering
the imaging
assembly. A feeding outlet is proximate the imaging assembly and in fluid
communication with
the feeding passage for delivering enteral feeding liquid to the subject. A
console connector is
communicatively connected to the imaging assembly, the console connector
configured for use in
communicatively connecting the imaging assembly to a console to allow
transmission of the
imaging signals to the console.
[0050] In yet another aspect, a feeding tube system generally comprises a
feeding tube assembly
and a console. The feeding tube assembly includes a feeding tube having
opposite first and
second ends and a feeding passage fluidly connecting the first and second
ends. An inlet adaptor
is adjacent the second end of the tube in fluid communication with the feeding
passage. The
inlet adaptor is configured for fluid connection to a source of enteral
feeding liquid to fluidly
connect the source of enteral feeding liquid to the feeding passage. An
imaging assembly
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including an imaging device and configured for generating and transmitting
imaging signals
indicative of images of the alimentary canal of a subject can be utilized. The
imaging assembly
is secured to the tube adjacent the first end of the tube and is sealed from
the feeding passage to
inhibit enteral feeding liquid in the feeding passage from entering the
imaging assembly. A
feeding outlet is intermediate the inlet adaptor and the imaging assembly and
in fluid
communication with the feeding passage for delivering enteral feeding liquid
to the subject. The
console includes a display, and is operatively coupled to the feeding tube
assembly and
configured for receiving imaging signals transmitted by the imaging assembly
and displaying
images generated from the imaging signals on the display.
[0051] In another embodiment, a feeding tube assembly generally comprises a
flexible feeding
tube having opposite first and second longitudinal ends, and a feeding passage
defined therein
extending between the first and second ends. An inlet adaptor is adjacent the
second longitudinal
end of the tube in fluid communication with the feeding passage. The inlet
adaptor is configured
for fluid connection to a source of enteral feeding liquid. An imaging
assembly includes an
imaging device for generating imaging signals indicative of images of the
alimentary canal of a
subject. The imaging assembly is secured to the feeding tube adjacent the
first end of the tube
and is fluidly isolated from feeding passage. A console connector is secured
to the feeding tube
proximate the inlet adaptor. The console connector is communicatively
connected to the imaging
assembly, and configured for use in connecting to the imaging assembly to a
console to allow
transmission of the imaging signals to the console.
[0052] In yet another embodiment, an imaging catheter assembly generally
comprises an
elongate body having a first body end, and an opposite a second body end; and
an imaging
assembly secured to the first body end. The imaging assembly has a first
imaging assembly end
remote from the first body end, a second imaging assembly end adjacent the
first body end, and
an imaging assembly longitudinal axis extending between the first and second
imaging assembly
ends. The imaging assembly includes a rigid-flex circuit having an electronic
component-
mounting portion extending along the imaging assembly longitudinal axis from
adjacent the
second imaging assembly end toward the first imaging assembly end, and a
camera-mounting
portion adjacent the first imaging assembly end and extending generally
transverse to the
imaging assembly. The electronic component-mounting portion includes
longitudinally spaced
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first and second rigid sections and a first flexible section disposed between
the first and second
rigid sections. A first electronic component is mounted on the first rigid
section of the electronic
component-mounting portion. A second electronic component is mounted on the
second rigid
section of the electronic component-mounting portion. A camera is mounted on
the camera-
mounting portion, and the camera is communicatively connected to the first and
second
electronic components. The rigid-flex circuit is disposed in a housing. The
housing
circumferentially surrounds at least a portion of the rigid-flex circuit. The
first flexible section of
the electronic component-mounting portion is free from electronic components
mounted thereon
such that the rigid-flex circuit is capable of bending at the first flexible
section.
[0053] In another aspect, an imaging catheter system for use in performing a
medical procedure
generally comprises an imaging catheter and a console. The imaging catheter
includes an
elongate body having opposite first and second ends. An imaging assembly at
the first end of the
body is adapted to be inserted into a subject. The imaging assembly includes
an imaging device
for generating imaging signals representative of images of anatomy of the
subject when the
imaging assembly is inserted in the subject. The imaging assembly is adapted
to transmit the
imaging signals generated by the imaging device. The imaging catheter includes
an electronic
memory component. The console including a display, and is configured for
receiving the
imaging signals transmitted by the imaging assembly and displaying images
generated from the
imaging signals on the display. The console is configured to write data to the
electronic memory
component during use of the imaging catheter.
[0054] In another aspect, an imaging catheter system for use in performing a
medical procedure
generally comprises an imaging catheter and a console. The imaging catheter
includes an
elongate body having opposite first and second ends. An imaging assembly at
the first end of the
body is adapted to be inserted into a subject. The imaging assembly includes
an imaging device
for generating imaging signals representative of images of anatomy of the
subject when the
imaging assembly is inserted in the subject. The imaging assembly is adapted
to transmit the
imaging signals generated by the imaging device. The console includes a
display. The console is
configured for receiving the imaging signals transmitted by the imaging
assembly and displaying
images generated from the imaging signals on the display. The console is
configured to
simultaneously present an image previously received by the console from the
imaging assembly
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and a current image from image data currently being received by the console
from the imaging
assembly.
[0055] Referring now to the drawings and in particular to FIGS. 1-3, an
imaging catheter is
generally indicated at 10. As disclosed herein, the imaging catheter can be a
medical device that
is configured for insertion into a subject, e.g., a human or a non-human
subject, and configured
to provide images, e.g., digital video, of anatomy of the subject as the
medical device is inserted
into the subject and/or after the medical device is positioned in the subject.
In the illustrated
embodiment, the imaging catheter is configured as a feeding tube assembly 10
and exemplarily
illustrated as a nasogastric feeding tube assembly. The nasogastric feeding
tube assembly 10 can
be configured to provide digital images of an alimentary canal, or portions
thereof, of the subject
as the feeding tube assembly is inserted into the subject and after the
feeding tube assembly is
positioned in the subject to facilitate confirmation of proper placement of
the feeding tube
assembly in the subject. The nasogastric feeding tube assembly 10 can be also
configured to
deliver liquid nutrients into the alimentary canal of the subject by enteral
feeding, such as after a
user, e.g., a medical practitioner, confirms proper placement of the feeding
tube assembly in the
subject, by viewing the acquired digital images from the imaging feeding tube
assembly. It is
understood that the imaging catheter 10 may be configured as a different type
of feeding tube,
such as a gastric feeding tube, or a jejunostomy feeding tube, or may be
configured as a different
type of medical device, such as an endoscope, or a heart catheter, e.g., a
balloon catheter or a
heart catheter.
[0056] The illustrated feeding tube assembly 10 generally includes an
elongate, generally
flexible body in the form of a feeding tube, generally indicated at 12, having
a longitudinal axis
A (FIG. 6), an open first longitudinal end, or a distal end, and an open
second longitudinal end,
or a proximal end. A feeding passage 14 (FIGS. 4-6), defined by an interior
surface of the
feeding tube 12, extends longitudinally between the longitudinal ends of the
tube for delivering
nutrients, e.g., in the form of an enteral feeding solution to the subject. In
other embodiments -
such as catheters that are not feeding tubes - the elongate body may have
other configurations,
and may not have a longitudinal passage for delivering fluids to the patient.
An inlet adapter,
generally indicated at 16, for delivering liquid nutrients into the feeding
passage 14 is attached to
the second end of the tube, and an imaging assembly, generally indicated at
18, for generating
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and transmitting real time images, e.g., live video, of the alimentary canal
of the patient during
and/or following intubation is attached to the first end of the tube 12 by an
imaging assembly
connector, generally indicated at 20. As used herein with the point of
reference being the feeding
source, the inlet adaptor 16 defines the proximal end of the feeding tube
assembly 10, and the
imaging assembly 18 defines the distal end. The feeding tube assembly 10 also
can include a
console connector, generally indicated at 22, in communication with the
imaging assembly 18, to
provide communication between the imaging assembly and a console 23 (FIG. 3),
on which the
images obtained by the imaging assembly 18 may be displayed, as described in
detail herein. In
the illustrated embodiment, the feeding tube assembly 10, the console 23, and
an interface cable
242, which communicatively connects the feeding tube assembly to the console,
together
constitutes an imaging catheter system, and more specifically, an imaging
feeding tube system.
[0057] Referring to FIGS. 1-4, the exemplarily illustrated feeding tube 12
comprises two tube
segments: a first tube segment 12a extending between the imaging assembly
connector 20 and
the console connector 22, and a second tube segment 12b extending between the
console
connector and the inlet adaptor 16. As disclosed in more detail below, the
first and second tube
segments 12a, 12b can be secured to the console connector 22 in such a way
that the first and
second tube segments are in fluid communication with each other to at least
partially define the
feeding passage 14. In other embodiments of the invention, the tube 12 may be
formed as an
integral, one-piece component.
[0058] The tube 12 may comprise indicia such as graduations (not shown) that
show or
providing a relative indication of insertion depth to facilitate proper
intubation. In one example,
the tube 12 may have a length between about 36 inches and about 55 inches,
although it may be
of other lengths without departing from the scope of the invention.
[0059] As shown in FIG. 6, the first tube segment 12a typically includes one
or more electrical
conductors 24 (broadly, a signal-transmitting component) typically disposed in
the tube wall of
the first tube segment. The second tube segment 12b may be free from such
electrical
conductors. The electrical conductors 24 of the first tube segment 12a run
longitudinally along
the first tube segment, such as along or parallel a longitudinal axis of the
feeding passage 14. At
least some of the electrical conductors 24 can be configured to transmit
imaging signals between
the imaging assembly 18 and the console 23, such as through the console
connector 22 and the
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interface cable 242. Other electrical conductors 24 may be configured to
transmit power from
the console 23 to the imaging assembly 18, and provide a ground. Still other
electrical
conductors 24 may be configured to provide other communication including, but
not limited to,
two-way communication, between the console 23 and the imaging assembly 18. The
first tube
segment 12a may include a different type of a signal-transmitting component,
such as fiber-optic
cables or other signal-transmitting components, to effect transmission of
signals between the
imaging assembly 18 and the console connector 22. In one or more embodiments
of the
invention, at least one of the electrical conductors 24 is configured to
supply power from a power
supply, which can be the console 23, to the imaging assembly 18, although
other ways of
powering the imaging assembly, including the imaging assembly having its own
source of power,
do not depart from the scope of the present invention.
[0060] As exemplarily illustrated, the electrical conductors 24 can be
disposed within a
conductor passage 26 of the feeding tube 12 so that the conductors are
physically separated or at
least fluidly isolated from the feeding passage 14 to inhibit or reduce the
likelihood of feeding
solution in the feeding passage from contacting the conductors. As shown in
FIG. 6, the interior
surface defining a portion of the feeding passage 14 in the first tube segment
12a has a generally
circular cross section having an arcuate portion 28 extending inwardly and
running longitudinally
along a lengthwise dimension of the feeding tube assembly or segment. The
electrical
conductors 24 can be disposed within the tube wall of the first tube segment
12a between the
arcuate portion 28 of the interior surface and the exterior surface of the
tube segment which
provides a configuration that allows physical separation between the
electrical conductors 24 and
the enteral feeding solution in the feeding passage 14, as disclosed above,
and can maximize the
area or volume of the feeding passage. A longitudinal axis A passes through
the feeding passage
14. As such, this configuration promotes the flow of fluid in the feeding
passage 14 and reduces
the likelihood of occlusions in the feeding passage. A substantially uniform
wall thickness
around passage 14, as shown in FIG. 5, can decrease the amount of material
entrapment that may
occur, or at least can reduce the likelihood of formation of occlusions. It is
understood that the
first tube segment 12a may be of other configurations without departing from
the scope of the
present invention.
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[0061] The feeding tube 12, including, for example, the first and second tube
segments 12a, 12b,
may be formed from a thermoplastic polyurethane polymer, such as but not
limited to, an
aromatic, polyether-based thermoplastic polyurethane, and a radiopaque
substance, such as
barium. The first and second tube segments 12a, 12b may be formed by an
extrusion process.
The tube 12 may be formed from other materials and may be formed in other ways
without
departing from the scope of the present invention. In one non-limiting
example, the electrical
conductors 24 or other signal-transmitting components may be co-extruded with
the first tube
segment 12a to embed the conductors in the first tube segment. In another
example, the
conductors 24 or other signal-transmitting components may be fed through the
conductor passage
26 after forming the first tube segment 12a. Introducing any of the one or
more conductors 12
can be facilitated by, for example, internally pressurizing passage 26 with a
fluid prior to
insertion therein. Other ways of forming the first tube segment 12a and/or the
tube 12 do not
depart from the scope of the present invention.
[0062] Referring back further to FIGS. 1 and 2, the illustrated inlet adaptor
16 typically includes
first and second inlet ports 30, 32, respectively, in fluid communication with
a single outlet port
34. The exemplarily illustrated inlet adaptor 16 may be referred to as a Y-
port. The first inlet
port 30 may be used for connection to a source of liquid nutrients, such as an
enteral feeding
solution. For example, a barbed connector (not shown), in fluid communication
with the source
of an enteral feeding solution, may be inserted into the first inlet port 30
and secured therein by a
friction-fit. Thus, an aspect of the present invention may involve
configurations with the feeding
fluid in fluid communication with the feeding tube assembly. An optional cap
35 tethered on the
inlet adaptor 16 can be removably receivable in the first inlet port 30 to
close the inlet port when
it is not being used. The second inlet port 32 may be used for connection to a
source of
medicine. Optional tethered first and second caps 36, 37, respectively, can be
used to variably
configure the second inlet port 32 as a connection or port to various or
different connectors
typically used with various sources of medicine. For example, the first cap 36
can be removably
receivable in the second inlet port 32, providing a central opening
therethrough that is sized and
shaped to mate with a catheter syringe. The second cap 37 can be removably
receivable in the
central opening in the first cap 36, thereby providing a central opening that
is sized and shaped to
particularly mate with a tip of an oral syringe. The inlet adaptor 16 may have
other shapes, sizes
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and configurations, or may be entirely omitted, without departing from the
scope of the
invention.
[0063] The inlet adaptor 16 can be secured to the second or proximal end of
the tube 12 at an
adaptor weld, generally indicated at 38, so that the outlet port 34 of the
adaptor 16 is in sealed
fluid communication with the feeding passage 14 of the feeding tube. The
adaptor weld 38
typically tapers distally from the adaptor 16 to the tube 12 so that the weld
has a smooth,
generally continuously decreasing diameter. It is to be understood that the
adaptor 16 may be
secured to the tube 12 in other ways without departing from the scope of the
invention. For
example, the inlet adaptor 16 may be secured to the tube 12 by solvent
bonding, or other
securement techniques. The adaptor 16 may be composed of the same material as
the feeding
tube 12, or a blend of materials, or a different but compatible material. In
one example, the
adaptor 16 is composed of blend of polyvinyl chloride and polyurethane
elastomer. In another
example, the adaptor 16 is composed of an aromatic, polyether-based
thermoplastic polyurethane
or DEHP-free PVC. The adaptor 16 may be formed from other types of materials
within the
scope of the invention.
[0064] Referring to FIGS. 1, 2, and 5, the imaging assembly connector 20 can
have a first end
margin, such as a distal end margin, secured to the imaging assembly 18, and a
second end
margin, such as a proximal end margin, secured to the first end margin of the
first tube segment
12a. The imaging assembly connector 20 typically defines a feeding outlet 40
that is in fluid
communication with the feeding passage 14 of the tube 12. The feeding outlet
40 can comprise
one or more openings extending laterally through a side of the imaging
assembly connector 20
(only one such lateral opening is illustrated). In the illustrated embodiment,
the first or distal end
of the tube 12 is received and secured within the imaging assembly connector
20 at the second or
proximal end of the imaging assembly connector to provide fluid communication
between the
feeding passage 14 and the feeding outlet 40. The imaging assembly connector
20 can be closed
adjacent the first or distal end to prevent the feeding solution in the
feeding passage 14 from
entering the imaging assembly 18. Thus, the imaging assembly 18 is typically
sealed off from
and not in fluid communication with the feeding passage 14. Instead, the
feeding solution
typically flows laterally out from the outlet 40 relative to the feeding tube
12. When the feeding
tube assembly 10 is determined to be appropriately positioned in a patient,
feeding solution or
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other desirable liquid fed into the inlet adaptor 16 can be introduced through
the feeding passage
14 of the tube 12, and out through the outlet 40 and into the subject's
alimentary canal. As
illustrated in FIG. 5, the first end margin of the imaging assembly connector
20 can have a
connection portion 42 shaped and sized to fit in the imaging assembly 18. The
imaging assembly
connector 20 may be formed integrally with the imaging assembly 18 or may be
omitted, without
departing from the scope of the present invention.
[0065] The electrical conductors 24 may be embedded or otherwise received in
the wall of the
imaging assembly connector 20 so that the conductors are sealed from the
feeding outlet 40 and
the feeding passage 14 to inhibit feeding solution from contacting the
conductors. In one
embodiment, the imaging assembly connector 20 may include two distinct parts
that are
assembled together. The first part may define the feeding outlet 40 that
receives liquid from the
tube 12, as described above, and a conductor passage (not shown) that is
separate and apart from
the feeding passage outlet. The second part may define the connection portion
42 and a
conductor passage extending to a conductor passage in the first part to
facilitate connection of or
carry the electrical conductors 24 between the imaging assembly 18 and the
tube 12. The
imaging assembly connector 20 may be omitted or may have other shapes, sizes,
and
configurations. Moreover, the imaging assembly 18 may be secured to the tube
12 in other ways
without departing from the scope of the present invention.
[0066] In one example, the imaging assembly connector 20 may be injection
molded onto the
end of the feeding tube 12. The direct connection of the imaging assembly
connector 20 to the
feeding tube provides strain relief for the electrical conductors 24 extending
out of the end of the
feeding tube 12 to the imaging assembly.
[0067] Referring to FIG. 5, the imaging assembly 18 can include a tubular
housing 50, a flexible
circuit ("flex circuit") assembly 60 disposed within the tubular housing, and
a transparent or
translucent cap 70 secured to the tubular housing 50. A flex circuit typically
includes a
deformable circuit element and components mounted on the deformable circuit
element. The
deformable circuit element may be a flat substrate, at least prior to being
deformed, that can be
bent or otherwise deformed, and which includes electrical conductors for
making electrical
connection among various components that may be mounted on the substrate. The
deformable
circuit element may only be partially deformable, e.g., only at discrete bend
lines, within the
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scope of the present invention. Among other functions, the tubular housing 50
can provide
protection for the flex circuit assembly 60, and the housing may be waterproof
to inhibit the
ingress of liquid into the imaging assembly 18. The tubular housing 50 has an
interior surface
defining an axial passage 52 shaped and sized for housing the flex circuit
assembly 60 in a folded
configuration. In one embodiment, the tubular housing 50 is formed from a
generally flexible
material that provides protection for the flex circuit assembly 60 and allows
the imaging
assembly 18 to bend to facilitate maneuverability of the feeding tube assembly
10. A second
end, such as a proximal end, of the tubular housing 50 can be configured to
receive the
connection portion 42 of the imaging assembly connector 20, and can be adhered
thereto to
secure the imaging assembly to feeding tube 12. The tubular housing 50 may be
generally
opaque, by being formed from an opaque white material or having an opaque
material applied
thereon, to reflect illumination from a light source, such as an internal LED
96, and direct the
illumination outward from the distal end of the imaging assembly 18 to, for
example, a field of
view.
[0068] The flex circuit assembly 60 typically includes a flex circuit 80 and
electronic
components (not labeled), described below, attached thereto. In the partially
assembled or folded
configuration exemplarily shown in FIGS. 5, 7, and 8, the flex circuit
assembly 60 can have a
length with a first longitudinal end, e.g., a distal end, and an opposite
second longitudinal end,
e.g., a proximal end. The electrical conductors 24 can be connected to the
second longitudinal
end, e.g., the proximal end, of the flex circuit assembly 60. A camera-
mounting portion 82 is
typically disposed at the first longitudinal end, e.g., the distal end of the
flex circuit assembly 60.
An imaging device such as a digital camera, generally indicated at 84, can be
mounted on the
camera-mounting portion 82. The camera 84 can have a cuboidal shaped housing
86 with a base
86A, as shown in FIG. 8, sides 86B, 86C, 86D, 86E, and an upper or first
surface 86F. The
upper surface 86F of the camera 84 can include a lens 88. The lens 88 defines
a field of view
that projects generally outward from the distal end of the imaging assembly
18. In accordance
with one or more embodiments of the invention, the camera 84 comprises an
imaging device,
such as a CMOS imaging device. In further embodiments of the invention, the
camera 84 may
comprise a different type of solid state imaging device, such as a charge-
coupled device (CCD),
or another type of imaging device. Other ways of configuring the electronics
and other
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components of the imaging assembly 18 do not depart from the scope of the
present invention
and may be implemented as variant embodiments. For example, in another
embodiment, the flex
circuit assembly 60 may be replaced with a rigid printed circuit board (PCB).
[0069] The flex circuit assembly 60 can include a power-mounting portion 90
(FIGS. 5 and 7)
and a control or data-mounting portion 92 (FIG. 8) each typically extending
from the camera-
mounting portion 82 at a fold line toward the first longitudinal end of the
flex circuit assembly
60. As will be described in further detail, power supply components are
typically disposed on
the power-mounting portion 90, and camera control components are typically
disposed on the
data-mounting portion 92.
[0070] Referring to FIGS. 7 and 9, a light-mounting portion 94 of the flex
circuit 60 can be
disposed at the side 86C of the camera 84. The light-mounting portion 94 is
illustratively
depicted as extending longitudinally toward the camera 84 from a lateral side
edge of the flex
circuit at a fold line of the power-mounting portion 90. One or more light
sources 96 can be
disposed on, for example, the light-mounting portion 94 for illuminating an
area or region
adjacent to the upper surface 86F of the camera housing 86. In the illustrated
embodiment, the
light source is a light emitting diode (LED) 96 disposed on the light-mounting
portion 94 so that
the LED is disposed on the side 86C of the camera housing and below or
proximate the upper
surface 86F of the camera housing. In the illustrated embodiment, the LED 96
has a light
emitting surface 98 substantially perpendicular to the light-mounting portion
94 for projecting
light outward from the distal end of the imaging assembly 18. According to the
illustrated
embodiment (FIG. 9), the LED 96 and the light-mounting portion 94 are
positioned relative to
the camera 84 and the camera-mounting portion 82 such that the light emitting
surface 98 of the
LED 96 is a relatively short distance, e.g., 0.408 millimeters, below the
upper surface 86F of the
camera housing 86. Typically, LED 96 has an illumination zone that is at least
partially
coincident over an imaging zone or field of view of camera 84, through
optional lens 88.
[0071] In another embodiment, one or more LEDs may be located distal of the
camera. As
shown in FIG. 44, one example of flex circuit assembly is generally indicated
at reference
numeral 60'. As illustrated in a folded or at least partially assembled
configuration, a flex circuit
80' of the flex circuit assembly 60' can include an electrical component-
mounting portion 90', a
camera-mounting portion 82' on which a camera 84' is mounted, and an LED-
mounting portion
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94' on which one or more light sources, such as four illustrated LEDs 96', can
be mounted. The
LED-mounting portion 94' is typically configured to rest on an upper surface
of the camera 84' so
that the LEDs 96' are distal or offset from the camera. The LED-mounting
portion 94' can
include an opening 95' aligned with the camera lens (not shown) so that the
LED-mounting
portion 94' does not obstruct the field of view of the camera 84'. FIG. 45
shows the flex circuit
80' in the unfolded or flat configuration. The flex circuit may have other
configurations and
provide alternative locations for mounting of the camera and the light source.
[0072] Referring to FIGS. 9 and 10, the camera 84 and the LED 96 are
illustratively shown as
disposed in the optically transparent cap 70. The cap 70 can be configured to
diffuse light
emitted from any of the one or more LEDs 96, and, in some cases, to filter the
emitted light into
a range of or a particular frequency. The cap 70 can have an exterior surface
comprising a
cylindrical attachment portion 100 that is configured to couple or mate with
the distal end of the
tubular housing 50, and a dome-shaped portion 102 that may extend outward or
project from the
tubular housing. In one example, the cylindrical attachment portion 100 can be
shaped and sized
so that a snug fit is formed with the interior surface of the tubular housing
50. A bonding agent
may be used to further secure the cylindrical attachment portion 100 to the
tubular housing 50.
The connection between the cap 70 and the housing 50 may be substantially
waterproof to inhibit
the ingress of liquid into the imaging assembly 18.
[0073] In some embodiments in accordance with one or more aspects of the
invention, the cap
70 has an interior surface that defines a cavity extending inwardly from a
proximal end of the
cap. The cavity can provide or define a camera-receiving portion 104 and an
LED-receiving
portion 106. The camera receiving portion 104 can be correspondingly sized and
shaped to
snugly or tightly receive the sides 86B, 86C, 86D, 86E of the camera 84, and
further can have a
depth (indicated as "D" in FIG. 9) that is less than the height of the camera
(indicated as "h" in
FIG. 9) so that the camera extends out of the camera receiving portion 104 at
the proximal end of
the cap 70. This snug fit of the camera 84 in the camera-receiving portion 104
inhibits
movement of the camera relative to the cap 70 and facilitates proper alignment
of the cap 70 with
the camera 84. The position of the cap 70 relative to the camera 84 may be
adjusted or
configured to at least partially reduce any effects that undesirably affect
the quality of the image
generated by the imaging assembly 18. In the exemplarily embodiment, the
protruding portion of
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the camera housing that extends outside of the camera receiving portion can
facilitate assembly
by enabling the use of a fixture for precise positioning of the camera and the
cap. In other
variants, the cap may utilize different configuration to interface with the
housing or other
components of the imaging assembly. For example, one or more variants
embodiments may
involve having circular cylindrical volumes enclosing any of the one or more
of the light sources
and the imaging devices.
[0074] Referring further to FIG. 9, the interior of the cap 70 can be further
configured to reduce
unwanted light emitting from the LED 96 from entering the camera 84 and being
sensed or
detected by the camera. To minimize or at least partially reduce any
reflection of undesirable
light into the camera 84, an interior camera-opposing surface 108 of the cap
70, opposing the
upper surface 86F of the camera housing 86, can be oriented or constructed to
be substantially
parallel to the upper surface 86F of the camera housing. Moreover, an interior
light-opposing
surface 110 of the cap 70 opposing the light emitting surface 98 of the LED 96
can be disposed
to be spaced longitudinally, i.e., distally, from the camera-opposing surface
108 of the cap. A
relatively sharp angle, e.g., a right angle, may be implemented and defined by
the camera-
opposing surface 108 and an interior surface 112 of the cap 70 that connects
the interior surface
110 to the interior surface 108. This configuration should reduce any
undesirable internal
reflection of light emitted by the LED 96 into the camera 84.
[0075] Referring further to FIG. 10, the dome-shaped portion 102 of the
exterior surface of the
cap 70 includes central distal portion 116 that can be generally flat, e.g.,
generally planar. Side
edges extending from the distal portion 116 to the base, e.g., proximal end of
the dome-shaped
portion, are round and generally smooth. Moreover, the base of the cap 70 has
a cross-sectional
size and shape that can be approximately the same as the cross-sectional size
and shape of the
housing 50 so that the cap transitions smoothly to the housing. Overall, this
general shape of cap
70 is referred to herein as a truncated-dome shape. The flat, central distal
portion 116 should
minimize or at least reduce distortion in the field of view. In the
illustrated embodiment, the flat,
central distal portion 116 has a generally circular circumference and an area
that is the same size
or larger than the field of view to further minimize distortion in the field
of view. Moreover, the
portion of the interior surface of the cap 70 that opposes the flat central
portion 116 of the
exterior surface and the upper surface 86F of the camera 84 can also be flat
and can be
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substantially in parallel with the flat central portion of the exterior
surface, which should further
minimize or at least reduce distortion in the field of view. The round edges
of the cap 70 can
facilitate insertion of the distal portion of the feeding tube assembly 12
into the subject and
promotes comfort during intubation.
[0076] Figure 11 shows an electrical block diagram directed to an exemplary
electrical system
200 of the flex circuit assembly 60 in accordance with one or more embodiments
of the
invention. Figures 12 and 13 illustratively show circuit diagrams of the
exemplary electrical
system 200. The electrical system 200 can include an electrical conductor
connector 202, such as
an insulation displacement connector, for receiving the electrical conductors
24 from the outlet
adaptor 20. According to the illustrated embodiment, the electrical conductors
24 include six
signal lines. The six signal lines in the illustrated embodiment include two
power supply lines,
e.g., a power line, 5V, and a ground line, GND, two serial communication
lines, e.g., a serial
clock line, SCL, and a serial data line, SDA, and a differential pair, e.g., a
low voltage
differential signal positive line, LVDS P, and a low voltage differential
signal negative line,
LVDS N. The power supply lines (5V and GND) are electrically connected to the
LED 96 for
energizing the LED 96. In the illustrated circuit system 200, the power supply
lines provide
Volt power to a white light LED, e.g., part number LW QH8G or LW VH8G
available from
OSRAM Opto Semiconductor GmnH, Germany. The power supply lines (5V and GND)
are also
electrically connected to a dual voltage regulator 204, or power supply, for
providing power
thereto. The dual voltage regulator 204 generates two different voltage lines
from the power
provided by the power supply lines. In the illustrated circuit system 200, the
dual voltage
regulator 204, e.g., part number I5L9016IRUJCZ-T available from Intersil
Corporation, Milpitas,
California, generates a 2.8 Volt power signal, e.g., analog supply voltage
signal VAA, and a
1.8 Volt power signal, e.g., digital supply voltage signal VDD. The dual
voltage regulator 204 is
configured and electrically connected to supply voltage generated therefrom to
an oscillator 206,
a serial communication device 208, and the camera 84. In the exemplary
electrical system 200,
the camera 84 can be part number MTV9124M01, available from Aptina Imaging
Corp., San
Jose, California. However, other cameras or image sensors may be used without
departing from
the scope of the invention.
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[0077] The oscillator 206, such as a 22 MHz oscillator, can be electrically
connected to the
camera 84 and configured to provide a timing signal (EXTCLK) thereto. The
serial
communication device 206, such as, an I2C bus repeater, available from Philips
Semiconducor or
NXP B.V, Germany, is electrically connected to the two serial communication
lines (SDA, SCL)
and to the camera 84 for allowing data, i.e., non-image data, to be
communicated to and from the
camera 84. For example, the serial communication lines (SDA, SCL) may be
connected via the
console connector 22 to an external computing device. The external computing
device receives
data representative of one or more camera settings, such as but not limited to
resolution and
frame rate. The camera settings can be communicated to the camera 84 via the
serial
communication lines (SDA, SCL) and the serial communication device 208. The
camera 84
obtains images of the subject's anatomy in the field of view during and/or
following intubation
thereof and generates imaging signals such as a serialized digital video
signal from the obtained
images as a function of the camera settings communicated via the serial
communication device
208. Operations performed by the camera 84 are synchronized as function of
timing signal
(EXTCLK) provided by the oscillator 206. The camera 84 outputs the signals,
e.g., serialized
digital video signal, to the differential pair lines (LVDS N, LVDS P) for
transmission to the
console connector 22 and to the console 23. The images obtained by the camera
84 may then be
delivered, processed, and viewed via the console 23.
[0078] FIG. 14 illustrates the flex circuit 80 in an unfolded, or flat, e.g.,
planar, configuration. In
the unfolded configuration, the camera-mounting portion 82, the power-mounting
portion 90, the
data-mounting portion 92, and the light-mounting portion 94 all lie generally
in the same plane
and form a single planar surface, e.g., mounting face. In one embodiment, all
of the electrical
components of the electrical system, e.g., electrical system 200 for the
imaging assembly 18 are
attached to a single, generally planar mounting surface 250 of the flex
circuit 80 when the flex
circuit is in the unfolded configuration. Accordingly, the electrical
components may be attached
to the flex circuit 80 while it is in the unfolded configuration to facilitate
manufacturing.
[0079] Relative locations of the electrical components of the exemplary
electrical system 200
described above are shown in FIG. 14. In particular, the electrical conductor
connector 202, e.g.,
insulation displacement connector, and the power supply 204, e.g., dual
voltage regulator, can be
attached to the mounting surface 250 of the power-mounting portion 90. A
configuration, such
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as the illustrated configuration, in which the power supply 204 is typically
located relatively
close to the incoming electrical conductors 24, minimizes or reduces noise on
the ground line
(GND). The oscillator 206, e.g., timing generator, and the serial
communication device 208, e.g.,
I2C bus repeater, can be attached to the mounting surface 250 of the data-
mounting portion 92.
The camera 84 can be attached to the mounting surface 250 of the camera-
mounting portion 82.
The exemplarily illustrated configuration locates the serial communication
device 208 further
from the electrical conductor connector 202 than the camera 84 because serial
communication
signals, e.g., serial data and serial clock signals, communicated between the
serial
communication device 208 and the electrical conductor connector 202 have a
lower bandwidth
than the video signal communicated from the camera 84 to the electrical
conductor connector
202. An LED 96 is attached to the light-mounting portion 94. The camera-
mounting portion 82
is shaped and configured so that the light-mounting portion 94 can be disposed
to be flush with a
side 86C of the camera housing when the flex circuit assembly 60 is in the
folded configuration
described above.
[0080] In one embodiment, the flex circuit 80 of flex circuit assembly 60 is a
two-layer circuit.
In particular, the flex circuit 80 includes a first substrate and a second
substrate, each having top
and bottom surfaces. The first and second substrates may be composed of a
flexible polyimide
film. Electrically conductive material, e.g., copper, selectively disposed on
the top surface of the
first substrate forms a first circuit pattern, e.g., plurality of selectively
connected traces. FIG. 15
illustrates a first circuit pattern for the exemplary electrical system 200 in
accordance with some
aspects of the invention. Electrically conductive material selectively
disposed on the top surface
of the second substrate forms a second circuit pattern. The first and second
substrates are
arranged in parallel with one another, e.g., stacked, so that the top surface
of the first substrate
directly opposes the bottom surface of the second substrate. The first circuit
pattern and the
second circuit pattern are electrically connected together by using, for
example, vias, and
connected with the electrical components attached to the flex circuit to form
a two-layer circuit.
The flex circuit 80 may be composed of other material and may be formed in
other ways without
departing from the scope of the present invention.
[0081] In one embodiment, the light-mounting portion 94 of the flex circuit 80
is configured to
function as a heat sink. The electrically conductive material on the top
surface of the first
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substrate and the electrically conductive material on the top surface of the
second substrate and
can be connected together using, for example, vias, to conduct heat from the
first substrate to the
second substrate. The traces formed on the second substrate of the light-
mounting portion of the
flex circuit can be wider relative to traces formed on other portions of the
first and second
substrates. For example, the wider traces may have a width of about 0.008
inches. This
configuration minimizes or can reduce the likelihood of a temperature increase
resulting from
heat generated by the LED 96, and can allow a greater current to be provided
to LED 96 to
maximize or increase the illumination capability generated by the LED 96,
while preventing or
reducing the likelihood of any damage to the LED 96 and disturbances to the
patient caused by
undesirable or unacceptable high temperatures.
[0082] Referring to FIGS. 7, 8, and 14, in order to convert the flex circuit
assembly 60 from the
flat configuration to the folded configuration, the power-mounting portion 90
and the data-
mounting portion 92 are folded toward each other at first fold lines 97 (FIGS.
7 and 8) to form
the camera-mounting surface 82 between the fold lines 97. The power-mounting
portion 90 and
the data-mounting portion 92 can be folded a second time at second fold lines
99 so that the two
portions are generally parallel and in opposing relationship to one another.
The light-mounting
portion 94 also can be folded inwardly toward the camera-mounting portion 82.
[0083] Alignment of the power-mounting portion 90 and the data-mounting
portion 92 during
assembly can be facilitated because there would be no components disposed on
the inner or back
surface of the flex circuit, i.e., the components are mounted on the mounting
surface. The
alignment of the power-mounting portion 90 and the data-mounting portion 92
also can improve
the alignment of the camera to a desired orientation. The stresses and forces
associated with the
foldlines 97 and 99 on either side of the camera-mounting surface 82 balance
each other out. As
a result, the equivalent or counteracting stresses or forces induces
positioning the camera 84 into
a particular orientation such that the lens 88 is aligned with the cap 70 and
the viewing field of
view of the lens 88 is can be coincident with the axis of the tubular housing
50.
[0084] FIG. 16 is a block diagram of an exemplary flex circuit electrical
system according to an
alternative embodiment of the invention. As shown, the electrical conductors
include four cables
constituting four signal lines. The four signal lines in the illustrated
embodiment include two
power supply lines, e.g., a power line, 5 V, and a ground line, GND, and a
differential pair, e.g., a
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low voltage differential signal positive line, LVDS P, and a low voltage
differential signal
negative line, LVDS N. A microcontroller 210 cooperates with camera 84 to
allow integration
into feeding tube assembly 10. The camera 84 includes, for example, an I2C
command/control
interface and a serialized digital video output interface. The microcontroller
210 can send
command and control signals directly to camera 84 rather than transmitting
these signals over the
length of the tube. Other operating parameters described herein, such as the
exemplary
embodiments associated with FIGS. 11-13, may be implemented in this variant.
[0085] In FIG. 17, the electrical conductors 24 include four cables
constituting four signal lines
in accordance with one or more further embodiments of the invention. The
camera 84 can be
customized to operate automatically and/or autonomously to a predefined
operating protocol
when powered up or energized. In this embodiment, camera 84 does not use or
rely on external,
incoming command/control signals. The operating parameters of the camera 84,
such as, but not
limited to, exposure, white balance, can be pre-programmed, pre-set, or
permanently set to
custom or tailored values for, for example, a particular or predefined
application. In one
embodiment, for example, the custom values would typically be stored in an
associated memory
structure. Camera 84 can include a sequencer (not shown), such as a
microcontroller integrated
in the camera module itself, which has a one time programmable memory (OTPM)
(not shown)
that can be programmed with the custom values. Alternatively, camera 84 can
include hardware
registers (not shown) that have the custom values stored therein, in which
case the sequencer
may be optionally operable. Other operating parameters described herein may be
implemented in
this embodiment.
[0086] FIG. 18 illustrates yet another embodiment of an exemplary flex circuit
electrical system.
As shown in FIG. 18, the electrical conductors 24 include two cables
constituting two signal
lines. The two signal lines in the illustrated embodiment include two power
supply lines, e.g., a
power line, 5V, and a ground line, GND, for supplying power from a console to
the flex circuit
60. The console 23 can energize or provide power to the flex circuit 60 and
can regulate voltage
as needed to power a radio 212A as well as the camera 84 and other components
of the flex
circuit 60. The camera 84 can then send imaging signals, such as video data,
via radio 212A
wirelessly to a corresponding radio 212B located at the console. In an
alternative embodiment,
the console 23 and the camera 84 can communicate bi-directionally via radios
212A, 212B to
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exchange, for example, non-video data. Providing power to camera 84 in this
manner can
eliminate the need for a limited-capacity energy source, such as a battery, in
the camera module
itself.
[0087] Reducing the number of signal lines as shown in FIGS. 16-18, especially
when combined
with a flex circuit, may reduce cost and improve reliability and ease of
assembly. Further, fewer
conductors can reduce the likelihood of inadvertently switching lines and
incorrectly connecting
them during assembly.
[0088] Referring to FIGS. 2 and 4A, the exemplarily illustrated console
connector 22 includes a
connector housing 228 and a printed circuit board (PCB) 230, secured to the
connector housing.
The PCB 230 includes an edge connector 232 extending outward from the housing
228 so that an
electrical component-mounting portion of the PCB is disposed in the connector
housing 228 and
the edge connector is exposed and thus can be generally accessible for a
connection thereto. In
the illustrated embodiment, the connector housing 228 defines a tube-
connection opening 234 in
which the first and second tube segments 12a, 12b are secured, such as by an
adhesive, to fluidly
connect the first and second tube segments. The tube-connection opening 234
may partially
define the feeding passage 14, or the feeding passage may be entirely defined
by the tube
segments 12a, 12b. In one non-limiting example, a one-piece tube 12,
incorporating or in lieu of
segments 12a and 12b, extends through the tube connection opening 234, such
that the feeding
passage is entirely defined by the tube and is not in fluid communication with
any portion of the
console connector 22. The tube 12 may be secured within the tube-connection
opening 234, such
as by adhesive. The console connector may be of other configurations and may
be secured to the
feeding tube assembly at other locations.
[0089] The electrical conductors 24 extend from the first tube segment 12a
into the connector
housing 228 and are electrically connected to the PCB 230. An interface cable
242 or other
signal-transmitting component can be removably connectable to the edge
connector 232 to effect
communication and data exchange between the console 23 and the imaging
assembly 18. As
explained in more detail below, an electronic memory component 243, such as
electrically
erasable programmable read-only memory (EEPROM), may be mounted on the PCB 230
to
allow information, i.e., data, to be stored and/or written thereon and to be
accessible by the
console 23, i.e., a microprocessor 254 of the console 23, or another external
device. The PCB
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230 may have additional or different electrical components mounted thereon, or
the PCB may be
omitted such that the electrical conductors are operatively connected to the
PCB 230.
[0090] In another embodiment, a console connector may be formed on or secured
to an inlet
adaptor. Referring to FIG. 4B, in one embodiment of the invention, a housing
228' of a console
connector 22' is formed integrally with an inlet adaptor 16'. The console
connector housing 228'
extends laterally outward from an outlet port 34' of the inlet adaptor 16'.
Like the previous
embodiment, the current console connector 22' optionally includes a PCB 230'
with an edge
connector 232' for use in communicatively connecting the imaging assembly with
the console.
An electronic memory component, such as an EEPROM (not shown) may be mounted
on the
PCB 230', as disclosed above and explained in more detail below. The feeding
tube assembly
may include a different type of connection for connecting the imaging assembly
18 to the console
23.
[0091] Referring to FIG. 3, the illustrated interface cable 242 includes first
and second interface
connectors 244, 246 on opposite longitudinal ends of the cable. The first
interface connector 244
is releasably mateable with and electrically connectable to the edge connector
232, and the
second interface connector 246 is releasably mateable with and electrically
connectable to the
console 23. One or both of the interface connectors 244, 246 may be
discriminating connectors,
i.e., non-universal connectors, that will only mate and connect with
respective connectors
associated with the feeding tube assembly 10 and the console 23. Moreover, the
edge connector
232 or other connector may be disposed within a socket having a shape that
selectively and
discriminatingly mates with a corresponding, e.g., complementarily configured,
first interface
connector 244. The socket and the first interface connector 244 may include
engagement
structures, such as ribs or other components that provide a friction-fit
between the connector and
the socket to inhibit inadvertent disconnection. The connection between the
interface cable 242
and the console connector 22 may be of other configurations without departing
from the scope of
the present invention.
[0092] Referring still to FIG. 3, the interface cable 242 may include a
control device, such as a
button 248, to allow the user to record a still image, e.g., take a snapshot
image, of real time
video being displayed on the console 23. Actuating the button 248 or other
control device sends
a signal to the console 23 instructing the console to record image
information, e.g., a still image
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along with associated temporal information. In one example, the control device
248 can be
proximate or on the first interface connector 244; for example, the control
device can be closer to
the first interface connector than the first interface connector 246. In one
or more exemplary
embodiments of the invention, the control device can be provided on the first
interface connector
or within 12 inches of the first interface connector. The console 23 may also
include a snapshot
control function, e.g., an icon, button, or other actuation device that allows
the user to take and
record a snapshot image using the console, that can be optionally stored in a
memory structure,
and which may include ancillary information such as the date and time. In some
situations or
embodiments it is envisioned that during insertion of the feeding tube
assembly 10 in the patient,
the console 23 may be located at a distance that is not within reach of the
user, such as a medical
practitioner. Thus, although the images, e.g., video, may be viewable on the
console 23, the user
may not be able to reach the console to perform additional operations or
functions on the console
during insertion of the feeding tube assembly 10. Accordingly, by providing a
control device 248
on the interface cable 242, and more specifically, by providing a control
device that is adjacent
the first interface connector 244, the user can take and record a snapshot
image without having to
reach for the console 23. The interface cable 242 may be of other
configurations without
departing from the scope of the present invention.
[0093] As shown in FIG. 3, the illustrated console 23 can include a console
housing 250, a
console display 252, such as an LCD or other electronic display, secured to
the housing, and a
microprocessor 254 disposed in the housing. In the illustrated embodiment, the
microprocessor
254 communicates with the imaging assembly 18 through the interface cable 242
and the
electrical conductors 24. The microprocessor 254 can be configured to receive
the imaging
signal or video signal transmitted by the imaging assembly 18 and display real-
time images
associated with the imaging signal on the display. As disclosed in more detail
below, the
microprocessor 254 can be optionally configured to display a graphical user
interface on the
console display 252, or a different display. The console 23 can include one or
more user input
devices to allow the user or operator to communicate with the microprocessor
254 to perform
various operations using the console 23. The display 252 may be a touchscreen,
such as a
touchscreen LCD or other types of displays, which also functions as a user
input device. In one
embodiment, the touchscreen allows the image to be enlarged or reduced by
touching the screen
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with two fingers and either moving apart to enlarge or bringing together to
reduce the image size.
Other user input devices, in addition to or in lieu of the touchscreen display
242, such as a
mouse, a keyboard, a joystick, or other user input devices, may also be
provided. Some other
devices may include, without limitation, the ability to accept and act on
voice commands or upon
gestures by the clinician. These latter input devices have the advantage of
not requiring that one
be able to touch the console. Other ancillary components can be utilized in
the console 23,
including, but not limited to power supply subsystems and serial buses.
[0094] Referring to FIG. 4A, as disclosed above the console connector 22 on
the feeding tube
assembly 10 may include an electronic memory component 243, such as an EEPROM,
for
storing and/or writing data thereon that is accessible by the console 23 or
other internal or
external devices associated with the feeding tube assembly, such as the
enteral feeding pump.
One or more of the following types of information may be provided on or
written to the
electronic memory component in one or more embodiments of the present
invention.
[0095] In one non-limiting example, data relating to the feeding tube assembly
10 may be
written, stored, or otherwise incorporated into the electronic memory
component 243. For
example, data indicating the lot code and/or the item code, e.g., serial
number, may be written to
the electronic memory component 243, and be retrievable by the console 23 as a
predefined
identifier. Moreover, a proprietary verification code may be included in the
electronic memory
component 243 to provide information that can facilitate verification to the
console 23 that the
feeding tube assembly 10 is a valid feeding tube to be used with the console.
The console 23
may be configured, by, for example, executing instructions, to verify that the
feeding tube
assembly is an acceptable, proper, unexpired, or compatible feeding tube
assembly before
allowing operation or additional operation. Without proper validation, for
example, the console
23 may inhibit images from displaying on the console if the feeding tube
assembly 10 does not
have valid information, such as an acceptable code or an acceptable predefined
identifier. In
addition, data indicating whether the feeding tube assembly 10 is sterilized
may be written to the
electronic memory component 243. Other information relating to the feeding
tube assembly 10
may also be written to or otherwise incorporated in the electronic memory
component 243. The
electronic memory component may thus serve as a validation assembly or key
that would provide
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one or more predefined identifying information, e.g., a predefined identifier,
that can be utilized
by the console before or during operation thereof.
[0096] In another non-limiting example, the data indicating time, i.e., time
stamps, relating to the
feeding tube assembly 10 may be written to the electronic memory component
243. For
example, the date of manufacture of the feeding tube assembly 10 may be
written to electronic
memory component 243. When the feeding tube assembly 10 is connected to the
console 23,
such as by the interface cable 242, the console may read the data indicating
the date of
manufacture. In one non-limiting example, the console 23 may use the date of
manufacture to
determine if the feeding tube assembly 10 has exceeded its storage life. If
the feeding tube
assembly 10 has exceeded its predetermined storage life, the console 23 may be
configured or
execute programmed instructions that perform at least one of initiate an
alarm, communicate a
message indicating that the storage life is exceeded, and prevent viewing of
images from the
imaging assembly 18. In another example, upon connection of the feeding tube
assembly 10
with the console 23, the console may be programmed to write a start date of
service or date of
first use on the electronic memory component 243. This start date can be used
as a reference to
determine when the predefined usage life of the feeding tube assembly 10 has
been exceeded or
is about to expire. For example, after writing the start date to the
electronic memory component
243, the console 23 may be configured to determine the usage duration or use
life of the feeding
tube assembly, and compare the elapsed usage duration with an expiration date
(and time) to
determine the remaining usage life or whether the service life, usage time, or
both, of the feeding
tube assembly will expire or has expired. Other variants may involve
periodically, continually,
or continuously determining whether the current date or usage date exceeds the
expiration date.
If the console 23 determines that the usage life of the feeding tube assembly
10 has expired, then
the console may be programmed to at least one of initiate an alarm,
communicate a message
indicating that the usage life is expired, make a record on any recorded
images, and prevent
viewing of images from the imaging assembly 18. The cumulative use time may be
determined
by writing time stamps to the electronic memory component 243 to determine the
hours of actual
use.
[0097] The console 23 may be configured to write other information to the
electronic memory
component 243. For example, the console 23 may be programmed to write a serial
number or
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other identifier associated with the console so that other consoles and other
devices, such as
enteral feeding pumps, can read the electronic memory component 243 and
determine which
console was used with the selected feeding tube assembly 10. In another non-
limiting example,
the console can be configured to write to the electronic memory component 243
patient specific
information including, for example, the subject's, e.g., the patient's, name,
the subject's
identification code, and other information relating to the patient, including
but not limited to, the
type of enteral product to be fed to the patient as well as the patient's
feeding schedule, feeding
duration, associated feeding settings, or other historical information. The
patient information
may be written to the electronic memory component 243 before the feeding tube
assembly 10 is
connected to the console 23, and the console may be programmed to read the
patient information.
Alternatively, the user may use the console 23 to write the patient's
information to the electronic
memory component 243. The patient's information may be encrypted to ensure
patient
confidentiality.
[0098] In yet another non-limiting example, a placement-confirmation time
stamp or some other
confirmation identifier may be written to the electronic memory component 243
to indicate that
the proper placement of the feeding tube assembly 10 in the patient was
confirmed. The console
23 may be configured to write the time stamp to the electronic memory
component 243 when the
user indicates to the console that the feeding tube assembly is properly
located. For example, the
user may press a button or perform some other operation to confirm proper
placement. In
addition to a time stamp or other confirmation identifier, a username or other
user identification
can be written to the electronic memory component 243.
[0100] Figures 19-31 illustrate one or more features relating to an exemplary
graphical user
interface of the console. One or more of the features described herein may be
incorporated into
various embodiments of the invention. FIG. 19 is a flow chart illustrating the
operations of the
graphical user interface when the console 23 is powered on for the very first
time, or when the
console is activated after a predetermined time period of non-use by a user.
The predetermined
period of non-use can be one month, six months, or even one year. Other
triggering conditions
that may affect a first time start may involve a loss of power.
[0101] As illustrated, a user interface screen prompts a user to indicate
whether the user is the
very first user of the console 23 ("initial user"), or whether the user has
already been associated
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with the console. If the user is the initial user, the console 23 grants the
initial user administrator
status along with associated privileges for accessing all or predetermined
features of the console.
Accordingly, at 302, the initial user is prompted to select a language
(labeled "Language") that
will be displayed on the user interface screens to communicate with users. At
304, the initial
user is prompted to enter the current date and time, and optionally to specify
a format for
displaying the time (labeled "Date/Time"). At 306, the initial user is
optionally prompted to
enter time tracking options for display by the user interface (labeled "Time
Display"). The initial
user can select one of the following options: the current time of day is
tracked and displayed by
the console 23; the elapsed amount time for the current procedure being
conducted by the feeding
tube assembly 10, e.g., initiated when patient data is entered, is tracked and
displayed by the
console; both, the current time of day and the elapsed amount of time for the
current procedure
being conducted are tracked and displayed by the console. At 308, the initial
user is optionally
prompted to set up an administrator account by entering a username and a
password.
[0102] If the user indicates that the user is not the very first user of the
console 23, the console,
at 310, presents to the user a log-in user interface screen. The user enters a
username and
password. If the user enters a valid username and password associated
therewith, the user is
logged in. If the console 23 determines that the username and password are not
valid, the
console presents the user with a log-in retry, i.e., message and another
opportunity to log in. In
one embodiment, after a predefined number of log-in attempts, the console 23
may be reset; all
patient data, user data, and device data may be deleted, locked or becomes
otherwise
inaccessible. If the user is successfully logged in, at 312, the user is
presented with a main
selection user interface screen. The main selection user interface screen can
present the user with
one or more of the following navigational options: utility functions,
procedure screen, file
functions, and logout. The navigational options may be presented via text
and/or graphical icons.
In addition, a portion of the main selection user interface screen (labeled
"Preview Video" or
graphically represented as a movie reel icon, for example) is dedicated to
providing the user with
video data if video data is being received from the imaging assembly 18 when
the main selection
user interface screen is being accessed. As described below, this generally
occurs when the user
selects the main selection user interface screen after initiating a procedure.
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[0103] In one embodiment, the console 23 is configured to recognize a
plurality of classes or
statuses of users and to limit operations that may be performed by the console
as a function of a
class associated with each user. For example, the console 23 may be configured
to recognize
four classes of users: operators, administrators, approvers, and maintainers.
The console 23 can
be configured to authorize the operator class of users to view video data that
is received from the
imaging assembly 18. The console 23 can be configured to authorize the
administrator class of
users to create or establish user accounts or other operator accounts, along
with respectively
associated data storage substructures, and to view video data that is received
from the imaging
assembly 18. The console 23 is configured to authorize the approver class of
users to view video
data or imaging data that is received from the imaging assembly 18 and to
annotate approval data
onto the video data or imaging data received from the imaging assembly. The
console 23 can be
configured to authorize the maintainer class of users to perform maintenance
functions to the
console such as software updates. However, the console 23 only authorizes the
maintainer class
of users to operate the console if the console is not storing any patient
data, e.g., patient data
must be deleted from console before a maintainer user is authorized to operate
the console.
[0104] If the user selects the utility functions from the main selection user
interface screen, a
utility functions user interface screen can be presented to the user. The
options presented to the
user on the utility functions user interface screen are typically based on the
class or status
associated with the user. If the user is an operator or an approver, the user
can be presented with
a utility functions user interface screen. The console can then provide the
user with the
"Language" option and the "Preview Video" feature discussed above. The utility
functions user
interface screen also can provide the user with a "User Manager" option which
allows the user to
navigate to a user manager navigation user interface screen that allows the
user to change his/her
password. If the user is an administrator, a utility functions user interface
screen presented to the
user has the "Language," "Date/Time," "Time Display," and "Preview Video"
options discussed
above. A "User Manager" option can also be provided, which allows the user to
navigate to a
user manager user interface screen. A user manager user interface for the
administrator allows
the administrator to add a user via the user interfaces. The utility functions
user interface screen
presented to the administrator also can also have an option, labeled
"Reset/Erase Console," for
resetting, e.g., deleting patient data, user data, and device data, or erasing
the console, e.g.,
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deleting patient data and device data, and for performing a software update,
labeled "SW
Update". In addition to the options presented to an administrator user, the
utility functions user
interface screen presented to a maintainer user additionally provides the
maintainer user with the
option to perform maintainer functions (labeled "Maintainer Functions"). For
example,
"Maintainer Functions" may include software debugging functions.
[0105] Referring again to the main selection user interface screen if the user
selects the
"Procedure Screen" option, a patient information user interface screen is
displayed to the user via
the console 23. The patient information user interface screen prompts the user
to enter a name
and identification for the patient for which the procedure is being performed.
If the user enters
the name and identification of the patient, the procedure main user interface
screen is displayed
to the user and the console 23 begins receiving video data from the imaging
assembly 18 of the
feeding tube assembly 10 so long as the feeding tube assembly 10 is correctly
connected to the
console. If the user does not enter the name and identification of the
patient, e.g., leaves the
Patient Name and Patient ID fields blank, the user is presented with the blank
patient information
user interface screen. The blank patient information user interface screen
allows the user to
select to proceed without the entering the patient information or to enter the
patient information.
If the user selects to enter the patient information, the user can be re-
directed to the patient
information user interface screen. If the user selects to proceed without
entering the patient
information, the procedure main user interface screen is displayed to the user
and the console 23
begins receiving video data from the imaging assembly 18 of the feeding tube
assembly so long
as the feeding tube assembly 10 is correctly connected to the console. If the
feeding tube
assembly 10 is not connected or is incorrectly connected to the console, the
user is presented with
an error message.
[0106] In one embodiment, the patient information may be manually entered by
the user. In
another embodiment, the console 23 may include a bar code scanner (not shown)
for scanning
the patient's bar code wristband to obtain the patient information. In yet
another embodiment,
the patient information can be provided on the electronic memory component
243. After
communicatively connecting the feeding tube assembly 10 to the console 23, the
console may
read and record the patient information from the electronic memory component
243. This
embodiment may be combined with the bar code scanner embodiment and/or the
manual-input
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embodiment to provide a cross-check for the patient to ensure that the correct
medical procedure,
e.g., enteral feeding, is being provided to the correct patient.
[0107] As illustrated in FIGS. 20 and 21, alternative procedure main user
interface screens can
display the video data or the rendered or processed imaging data being
received by the console
23 from the imaging assembly 18. The procedure main user interface screen also
can display any
of the current time if selected by the user at 350, the patient name and
identification number if
entered by the user at 352 and 354, respectively, and the time elapsed for the
current procedure if
selected by the user at 356. The time elapsed for the current procedure begins
when the user
enters the patient name and identification or selects to proceed without
entering the patient name
and identification. The procedure main user interface screen also includes an
option, e.g., icon or
button with text, for taking a snapshot at 358. The snapshot option 358 allows
a user to select to
store the current frame of the video data or the rendered imaging data
collected by the console
from the imaging assembly 18. Identifying information about the snapshot may
be automatically
provided and/or entered by the user on the console for later identification of
the snapshot. As
disclosed above, the interface cable 242 may include a control device 248,
which may be
provided in addition to or in lieu of the snapshot option 358 on the console
23. At 360, the
procedure main user interface screen provides the user with the file functions
option (labeled
"File Functions" or illustrated as a folder icon) which allows the user to
access files stored by the
console. The "File Functions" option may also be accessed directly from the
main selection user
interface screen. Upon selecting the "File Functions" options from either the
procedure main
user interface screen of FIGS. 19A and 19B, for example, or the main selection
user interface
screen, the user is directed to the file functions user interface screen.
[0108] The file functions user interface screen presents a user with a list of
directories stored on
the console, and also includes the "Preview Video" feature discussed above.
Each directory
represents the video data or the rendered imaging data that is stored in
connection with one
particular feeding tube assembly 10. In one embodiment, the console 23 can
read a serial
number or other unique identifier from the console connector 22. The serial
number or other
identifier may be specific to the feeding tube assembly 10 such that it
distinguishes it from all
other feeding tube assemblies. In the illustrated embodiment, the console
connector 22 includes
the electronic memory component 243 that stores the identifier for the feeding
tube assembly 10.
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All of the data that is received from the feeding tube assembly 10 having a
particular serial
number or other identifier can be stored under a single directory in the
console 23. Data that is
received from a feeding tube assembly 10 having a different serial number or
other identifier can
be stored under a different directory.
[0109] A user may select a directory for viewing and/or editing from the file
functions user
interface screen. When the directory is selected from the file functions user
interface screen, the
user is directed to the file functions directory selected user interface
screen (alternative
embodiments illustrated in FIGS. 22 and 23). This user interface presents the
list of files, e.g.,
image files, associated with the selected directory. The image files represent
the images selected
by the user via the snapshot option. The user is able to select at least one
file from the image
directory and export the file via the "Export" option 380, rename the file via
the "Rename" option
382, delete the file via the "Delete" option 384, and annotate or view the
file via the
"Annotate/View" option 386.
[0110] If the user selects the "Export" option 380 from the file functions
user interface screen,
the raw/JPEG user interface screen (alternative embodiments illustrated in
FIGS. 24 and 25) is
displayed. This user interface presents the list of files associated with the
previously selected
directory and allows the user to select one or more files. The user interface
allows the user to
specify a particular console universal serial bus (USB) port at 390 through
which the selected
files will be exported. A suitable number of busses may be provided. In one
embodiment two,
stacked busses are provided. In another embodiment, the console 23 may
additionally or
alternatively be configured to export the selected files wirelessly to a
receiving device and/or to
export the selected files to the receiving device via an Ethernet connection.
At 392, the user is
also presented at 392 with the option to delete the selected files from the
console once the
selected files have been exported. At 394 and 396, respectively, the user is
prompted to select
whether to export the file as an uncompressed file, e.g., raw file, or to
export the file as a
compressed file, e.g., JPEG file.
[0111] If the user selects the "Rename" option 382 from the file functions
user interface screen, a
rename user interface screen is presented to the user to allow the user to
rename the file. In one
embodiment the default format of the file is
DATE SUD-SN PT-NAME PTID TIME SEQ#1mg, wherein
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DATE = the current date (e.g., yyymmdd) set to the console via the "Date/Time"
feature;
SUD-SN = single use device serial number (e.g., the identifier retrieved by
the console 23 from
the console connector 22);
PT-NAME = patient name as entered by the user via the patient information user
interface
screen;
PT-ID = patient identifier as entered by the user via the patient information
user interface
screen;
TIME = the current time (e.g., hhmmss) set to the console via the "Date/Time"
feature;
SEQ# = the image number as received from the imaging assembly, wherein the
first image sent
from the imaging assembly has an image number of 1 and the image number for
each image
received thereafter is incremented by one.
[0112] In one embodiment, the "Rename" option 382 allows the user to change
only the SEQ#
portion of the file name.
[0113] If the user selects the "Delete" option 384 from the file functions
user interface screen,
the delete user interface screen is presented to the user to allow the user to
delete files. The
delete user interface screen can provide the user with a list of the files
included in the previously
selected directory. The user can select one more files from the directory and
then select the
delete option, e.g., delete button or icon. When the user selects the delete
option from the delete
user interface screen, the user is prompted via the delete confirmation user
interface screen, to
confirm that the selected files should be deleted from the console. Once the
user confirms that
the selected files should be deleted, the selected filed are deleted from the
console.
[0114] If the user selects the "Annotate/View" option 386 from the file
functions user interface
screen, a view user interface screen as shown in the alternative embodiments
of FIGS. 26 and 27
is displayed. The view user interface screen can display the image stored in
the selected file.
The view user interface screen also can provide the user with an "Annotate"
option at 400 and a
"Compare to Video" option at 402. If the user selects the "Compare to Video"
option at 402, the
console 23 presents a compare user interface screen to the user (alternative
embodiments
illustrated in FIGS. 28 and 29). A first portion 404 of the compare user
interface screen displays
the image stored in the selected file. A second portion 406 of the compare
user interface screen
can display video data or rendered imaging data currently being received by
the console from the
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imaging assembly 18. The images on both the first and second portions 404, 406
can in one
embodiment be zoomed or panned. By comparing a previously captured image
illustrating prior
tube placement within a patient to current video data illustrating current
tube placement within
the patient, a user can determine whether the tube has migrated within the
patient. Additionally
or alternatively, a user can compare an image of a previously placed tube to
current information
representative of a current tube placement to facilitate assessment as to
whether the tube
currently appears to be placed appropriately. It should be noted that the
first portion 404 and the
second portion 406 of the compare user interface screen are illustrated as
being horizontally
aligned; however, the first and second portions, 404 and 406 maybe
alternatively arranged with
respect to one another, e.g., vertically aligned, and may be modified by the
user without
departing from the scope of the invention.
[0115] The compare user interface screen provides the user with an "Annotate"
option at 408 and
a "Procedure Screen" option at 410. If the user selects the "Procedure Screen"
option 410, the
console redirects the user to the patient information user interface screen
described above. If the
user selects the "Annotate" option 408 from the compare user interface screen
(FIGS. 28 and 29),
or the "Annotate" option 400 from the view user interface screen (FIGS. 26 and
27), the console
presents the user with an annotate user interface screen illustrated in the
alternative embodiments
of FIGS. 30 and 31. The annotate user interface screen presents the user with
a "Text" option at
420, and "Line" option at 422, and "Approve" option at 424, an "Undo" option
at 426, and an
"Undo All" option at 428.
[0116] If the user selects the "Text" option 422, the annotate user interface
screen allows the user
to indicate, e.g., by touching or clicking, the portion of the image being
displayed on the annotate
user interface screen where the user would like to place the center of the
text. After receiving the
user input indicating the location of the text, the annotate user interface
screen displays
additional options to the user. In particular, the annotate user interface
screen provides the user
with the option to select text naming an anatomical structure from a text list
of anatomical
structures. The annotate user interface also provides the user with the option
to add free-text to
the image. If the user selects text naming an anatomical structure from the
text list, the selected
text appears on the screen centered over the user-selected text location. If
the user selects to add
free-text to the image, the annotate user interface screen adds a keyboard to
the annotate user
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interface screen and allows the user to enter text accordingly. If the
keyboard on the annotate
user interface screen covers the user-selected text location, the text entered
by the user is moved
upward until the user finishes entering the text. Once the text entry has been
completed, the
entered text can be displayed on the screen centered over the user-selected
text location.
[0117] If the user selects the "Line" option 422 the annotate user interface
screen allows the user
to indicate, e.g., by touching or clicking, the portion of the image being
displayed on the annotate
user interface screen where the user would like to place a first end of a line
segment. The user
may then indicate, e.g., via a drag and drop operation, where the second end
of the line segment
should be located on the annotate user interface screen. If the "Undo" option
426 is selected, the
last unsaved annotated item, e.g., text, line segment, is removed from the
image. This operation
can be repeated until there are no unsaved annotated items remaining in the
image. If the "Undo
All" option 428 option is selected, all unsaved annotated items are removed
from the image.
[0118] If the user selects the "Approve" option 424, the user can be re-
directed to the approver
user interface screen. The approver user interface screen prompts a user to
enter his/her
username and password. Once the username and password are entered, the console
attempts to
authenticate the user as being associated with approver status. If the user is
authenticated, a
message, such as "Approved by USERNAME on DATE at TIME" is added to the image,
e.g.,
upper left of image beneath the patient identification information, wherein
USERNAME = the username of the current user as entered in the approver user
interface
screen;
DATE = the current date (e.g., yyymmdd) set to the console via the "Date/Time"
feature;
TIME = the current time (e.g., hhmmss) set to the console via the "Date/Time"
feature.
[0119] Once an approver user has indicated that he/she approves the placement
of the tube, the
patient is allowed to be provided with nutrients via the feeding tube assembly
10. For example,
the console may be configured to provide a signal that allows operation of
feeding pump.
[0120] The order of execution or performance of the operations in embodiments
of the invention
illustrated and described herein is not essential, unless otherwise specified.
That is, the
operations may be performed in any order, unless otherwise specified, and
embodiments of the
invention may include additional or fewer operations than those disclosed
herein. For example,
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it is contemplated that executing or performing a particular operation before,
contemporaneously
with, or after another operation is within the scope of aspects of the
invention.
[0121] Embodiments of the invention may be implemented with computer-
executable
instructions. The computer-executable instructions may be organized into one
or more
computer-executable components or modules. Aspects of the invention may be
implemented
with any number and organization of such components or modules. For example,
aspects of the
invention are not limited to the specific computer-executable instructions or
the specific
components or modules illustrated in the figures and described herein. Other
embodiments of
the invention may include different computer-executable instructions or
components having
more or less functionality than illustrated and described herein.
[0122] Referring to FIGS. 32A-42, another embodiment of the imaging feeding
tube assembly is
generally indicated at 510. This embodiment is similar to the various
embodiments disclosed
above, and like components are indicated by corresponding reference numerals
plus 500.
Referring to FIGS. 32A and 32B, the imaging feeding tube assembly 510 includes
a feeding tube
512, a inlet adaptor, generally indicated at 516, adjacent a second
longitudinal end, i.e., a
proximal end, of the tube, an imaging assembly, generally indicated at 518,
adjacent a first
longitudinal end, i.e., a distal end, of the tube, and a console connector,
generally indicated at
522, secured to the tube intermediate the inlet adaptor 516 and the imaging
assembly 518. The
imaging feeding tube assembly 510 may be used with the console 23, or a
different console or
display, for displaying one or more images generated by the imaging assembly
518, as disclosed
above. The inlet adaptor 516 is analogous to the inlet adaptor 16, and
therefore, reference is
made to the prior inlet adaptor for an explanation of various features of the
inlet adaptor 516.
Unless otherwise specified below, disclosures relating to the components of
the previous feeding
tube assembly embodiment 10, set forth above herein, also apply to the
components of the
current feeding tube assembly embodiment 512.
[0123] The tube 512 can be a one-piece tube. Referring to FIG. 33, electrical
conductors 524
(broadly, a signal transmission component) extend longitudinally along
substantially the entire
length of the tube 512 from the imaging assembly 518 to the console connector
522. In the
illustrated embodiment, there are six electrical cables 524 for powering the
imaging assembly
518 and transmitting data between the console, e.g., console 23, and the
imaging assembly,
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although there may be more or less cables without departing from the scope of
the present
invention. In the illustrated embodiment the cables 524 are disposed in three
separate and
distinct conductor passages 526. The cables 524 are provided in pairs, with
each pair being
disposed within the same conductor passage 526 in the tube wall. In one
example, the cables 524
and the tube 512 may be co-extruded so that the cables are embedded in the
tube wall. After co-
extrusion, the cables 524 may be laser ablated to remove the respective
jackets and/or
mechanically stripped to expose the wires so that the cables can be
electrically connected to the
imaging assembly 518 and the console connector 522.
[0124] Referring to FIGS. 34-37, the imaging assembly 518 can include an
elongate housing
550; a flex circuit assembly, generally indicated at 560 (FIG. 35), including
a camera 584 and a
light source 596 mounted thereon and received in the housing; and a cap 570
attached to the
camera at a first longitudinal end, e.g., distal end, of the imaging assembly.
In this embodiment,
a flex circuit 580 of the flex circuit assembly 560 can be a rigid-flex
circuit including one or
more space apart rigid structures 561 mounted on the flex circuit which
inhibit bending. The
electrical components, such as those described above with respect to the
previous embodiment,
are mounted on the rigid structures 561. The rigid-flex circuit 560 is capable
of bending at
bending locations 581 between the rigid structures 561 such that the rigid-
flex circuit is capable
of selectively deforming solely at the bending locations 581 along the length
of the folded rigid-
flex circuit. The light source 596 and the camera 584 are mounted on the same
distal camera-
mounting portion 582 of the rigid-flex circuit 560, which extends generally
transverse to the
longitudinal axis of the imaging assembly 518. In the illustrated embodiment,
the camera-
mounting portion 582 can have one of the rigid structures 561 mounted thereon,
to which the
camera 584 and the light source 596 can be secured.
[0125] Electrical components for operating the imaging assembly 518 may be
similar or the
same as the electrical components disclosed above for operating the previous
embodiment of the
imaging assembly 18. In addition to those electrical components, the rigid-
flex circuit 560
includes decoupling capacitors, generally indicated at 598, for providing a
stable supply voltage
with low noise to the camera 84. In the illustrated embodiment, the decoupling
capacitors 598
are embedded in the camera-mounting portion 582 of the rigid-flex circuit 560
between layers
thereof. In this way, the decoupling capacitors 598 are immediately adjacent
the camera 584.
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[0126] Referring to FIGS. 40 and 42, the cap 570 may be similar to the cap 70
except that the
cavity in the cap 570 is typically sized and shaped for receiving the camera
584 only, without the
camera and the LED 596 as in the previous embodiment. In addition, referring
to FIG. 40, the
cap 570 includes a plurality of radial locking ribs 589 received in
corresponding radial locking
grooves 600 formed on the interior surface of the housing 550. The engagement
between the
locking ribs 589 and the locking grooves 600 inhibit longitudinal movement
between the housing
550 and the cap 570. The cap 570 may be of other configurations without
departing from the
scope of the present invention.
[0127] In one non-limiting example (FIG. 40), the housing 550 may be molded
and include
longitudinally spaced apart reinforcing structures 591, i.e., wall portions of
housing 550 with
increased thicknesses, and bending locations 593 with wall thickness of
housing 550 less that at
structures 591 disposed between the reinforcing structures. The reinforcing
structures 591 are
typically disposed adjacent the electronic components and the rigid structures
on the rigid-flex
circuit 580, while the bending locations 593 are typically disposed adjacent
the bending locations
on the rigid-flex circuit. Through this configuration, the cap 550 further
promotes bending of the
imaging assembly 518 at selected locations along its length and inhibits
bending at longitudinal
locations where the electronic components are located. The difference in wall
thickness of
housing 550 with respect to structures 591 and locations 593 can be less than
about 25%, less
than about 10%, or less than about 5%.
[0128] In another non-limiting example (FIG. 41), the housing 550 may be
molded over the cap
570, the rigid-flex circuit assembly 560, and the imaging assembly connector
520 to form an
integral imaging assembly 518. For example, the cap 570, the rigid-flex
circuit assembly 560,
and the imaging assembly connector 520 may be placed in a fixture of an
overmolding process,
and then the housing 550 may be molded over the components. The material for
overmolding
may comprise urethane or other material. In yet another embodiment, the
housing 550 may be
pre-formed and the cap 570 and the imaging assembly connector 520 may be
secured to the
respective ends of the housing, such as by solvent bonding or in other
suitable ways.
[0129] Referring to FIGS. 32A, 32B, 38, and 39, as with the previous feeding
tube assembly 10,
the current feeding tube assembly 510 includes an imaging assembly connector,
generally
indicated at 520. Like the previous embodiment of the imaging assembly
connector 20, the
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current imaging assembly connector 520 defines a feeding passage outlet 540
that is in fluid
communication with the feeding passage 514 of the tube 512. In the illustrated
embodiment, the
first longitudinal end of the tube 512 is received and secured in the feeding
passage outlet 540 of
the imaging assembly connector 520 to provide fluid communication
therebetween. The outlet
540 is closed adjacent to prevent liquid nutrients from entering the imaging
assembly 518. Thus,
the imaging assembly 518 is not in fluid communication with the feeding
passage 514. Instead,
the feeding solution is dispensed laterally from the outlet 540 and to the
patient (only one such
lateral opening is shown in FIGS. 32 and 38).
[0130] Referring to FIGS. 38 and 39, a first longitudinal end, e.g., a distal
end, of the imaging
assembly connector 520 defines an alignment slot 521 for receiving a proximal
end of the rigid-
flex circuit assembly 560. The alignment slot 521 facilitates proper
positioning of the rigid-flex
circuit assembly 560 relative to the imaging assembly connector 520. The
imaging assembly
connector 520 may be of other configurations without departing from the scope
of the present
invention.
[0131] Referring to FIG. 42, the console connector 522 can be secured to the
feeding tube 512
and can extend laterally outward therefrom. The present illustrated console
connector 522
includes a housing 728, and a PCB 730, an inlet adaptor connector 800, and a
feeding tube
connector 802 secured to the housing. A connector, such as a USB port
connector 532, may be
mounted on the PCB 730 for communicatively connecting an interface cable to
the PCB 730. In
another embodiment, the PCB 730 may include an edge connector, as disclosed
above with
respect to the previous embodiment. An electronic memory component 743 may be
mounted on
the PCB 730. The housing 728 can define a socket 736 having a size and shape
for mateably
receiving an interface connector (not shown) having a corresponding size and
shape. A
connector cap 737 can be tethered to the housing 728 for selectively closing
the socket 736 when
it is not in use.
[0132] The housing 728 may be molded over the inlet adaptor connector 800 and
the feeding
tube connector 802 to secure the connectors to the housing. The proximal end
of the feeding
tube 12 is secured within a connection passage 804 in the feeding tube
connector 802. The inlet
adaptor connector 800 connects the inlet adaptor 516 to the console connector
522 and defines a
passage 806 that fluidly connects the inlet adaptor 516 to the feeding tube
512. In another
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embodiment (not shown), the one-piece feeding tube 512 may pass through an
opening in the
console connector 522 and connect directly to the inlet adaptor 516. The
housing 728 may be
secured to the feeding tube 512 using adhesive or in other ways. The housing
728 may be
secured to the inlet adaptor 516, more specifically, to the distal end of the
inlet adaptor so that
the housing abuts the inlet adaptor. The console connector 522 may have other
configurations
without departing from the scope of the present invention.
[0133] Referring to FIG. 43, another embodiment of an interface cable for
connecting the
feeding tube assembly 10, 510 to the console 23 is indicated at 742. The
interface cable 742 is
similar to the interface cable 242 of the previous embodiment. Like the
previous interface able
embodiment 242, the present interface cable 742 can include first and second
interface
connectors 744, 746 on opposite ends of the cable. The illustrated first
interface connector 744 is
sized and shaped to mate, e.g., to be selectively inserted into, the socket
736 of the console
connector 522 and to make connection with the USB port connector 532, or an
edge connector or
another connector associated with the console connector. The first interface
connector 744
includes annular ribs or beads 770 that engage an interior surface of the
socket 736 to form a
substantially liquid-tight seal therewith to prevent the ingress of fluid into
the socket. The
second interface connector 746 is sized and shaped to mate, e.g., to be
selectively inserted into,
with a corresponding socket of the console 23 and to make connection with the
console. The
first and second interface connectors 744, 746 and the corresponding sockets
736 can be
configured so that the first interface connector 744 is not mateable with the
socket on the console
23 and the second interface connector 746 is not mateable with the socket 736
of the console
connector 522. The interface cable 742 may be of other configurations without
departing from
the scope of the present invention.
[0134] In the illustrated embodiment, first interface connector 744 can
include an imaging signal
buffer component 750, e.g., an I2C buffer component, which drives imaging
signals, e.g., I2C
signals, between the imaging assembly 18, 518 and the console. By locating the
imaging signal
buffer component 750 in the first interface connector 744, the capacitance is
split approximately
equally between the conductors 24, 524, e.g., wires in the cables, in the
feeding tube assembly
10, 510 and the conductors, e.g., wires, in the interface cable 742. This
configuration minimizes
or reduces capacitance in any one segment of the system and maximizes or
improves the image
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signal integrity. Moreover, the first interface connector 744 and the imaging
signal buffer
component 750 will be desirably adjacent the feeding tube assembly 10, 510
because the console
connector 22, 522 is mateable only with the first interface connector, and not
the second interface
connector 746. The interface cable 742 may not include an imaging signal
buffer component 750
and may be of other configurations without departing from the scope of the
present invention.
[0135] One or more aspects of the invention can involve a catheter can be
feeding tube having an
imaging assembly with an imaging device or sensor. The imaging assembly can
generate and
transmit imaging signals generated by the imaging device. The system can
include a console
adapted to receive the imaging signals and present images corresponding to the
imaging signals
on a display. Further, the console can be configured to selectively present a
reference menu on
the display including menu items. The menu items correspond to reference
materials comprising
any one or more of photographs, video recordings, audio recordings, diagrams,
animations, and
text. The materials provides information about any one or more of anatomy,
patient preparation,
imaging catheter preparation, imaging catheter placement, imaging catheter
operation, imaging
catheter features, console preparation, console operation, console features,
system operation,
system features, contact information, help information, and support
information. One or more
aspects of the invention can be directed to an imaging catheter system,
comprising a feeding tube
having an inlet connectable to a source of feeding fluid, an outlet distal
from and fluidly
connected to the inlet through a feeding passage, and an imaging device
disposed proximate the
outlet, the imaging device configured to generate and transmit imaging signals
corresponding to
an image of an anatomy of a patient; and a console comprising a display and
memory having
stored therein a plurality of reference materials selected from the group
consisting of audiovisual
data such as videos, audio, and photographs, textual data such as diagrams,
animations, and text,
and combinations thereof. In some cases, each of the plurality of reference
materials can provide
information about at least one of anatomy, patient preparation, imaging
catheter preparation,
imaging catheter placement, imaging catheter operation, imaging catheter
features, console
preparation, console operation, console features, system operation, system
features, and contact
information. Preferably, the console is configured to receive the imaging
signals, present at least
a portion of at least one image corresponding to the imaging signals on the
display, and present a
reference menu on the display including menu items corresponding to at least
one of the
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reference materials. The at least one of the plurality of reference materials
can include a
photograph showing an anatomical landmark. The anatomical landmark can be one
of a
bronchus, larynx, a tracheal ring, cardia, pyloric sphincter or pylorus,
cricoid cartilage, bronchial
split, esophageal junction, stomach folds, duodenal folds, and a pyloric
orifice.
[0136] One or more further aspects of the invention can be directed to a
method of facilitating
use of or providing a feeding tube assembly. The method can comprise providing
a feeding tube
having an inlet connectable to a source of feeding fluid, an outlet distal
from and fluidly
connected to the inlet through a feeding passage, and an imaging device
disposed proximate the
outlet, the imaging device configured to generate and transmit imaging signals
corresponding to
an image of an anatomy of a patient; and providing a console comprising a
display and memory
having stored therein a plurality of reference materials selected from the
group consisting of
photographs, video recordings, audio recordings, diagrams, animations, text,
and combinations
thereof. In accordance with some particular embodiments, each of said
reference material can
provide information about at least one of anatomy, patient preparation,
imaging catheter
preparation, imaging catheter placement, imaging catheter operation, imaging
catheter features,
console preparation, console operation, console features, system operation,
system features, and
contact information. In some cases, the console can be configured to receive
the imaging signals,
present at least a portion of at least one image corresponding to the imaging
signals on the
display, and present a reference menu on the display including menu items
corresponding to at
least one of the reference materials. In some cases, the console can be
configured to
simultaneously present on the display a photograph from the plurality of
reference materials and
a video image corresponding to the image signals from the imaging assembly,
wherein the
photograph provides a representative anatomical marker or landmark. The
method, in
accordance with further aspects of the invention, can comprise at least one of
storing additional
reference materials into the memory, removing at least one reference material
from the memory,
and replacing the memory with an updated memory, the updated memory having
stored therein at
least one updated reference material. The method, in accordance with other
further cases, can
comprise receiving the console from a user; and after receiving the console,
at least one of
storing additional reference materials into the memory, removing at least one
reference materials
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from the memory, and replacing the memory with an updated memory, the updated
memory
having stored therein at least one updated reference material.
[0137] Referring to FIG. 46, an imaging catheter system (broadly, a medical
system) is generally
designated in its entirety by the reference number 810. The system 810
includes an imaging
catheter, generally designated 812, and a console 814, operatively coupled to
the imaging
catheter by, for example, an interface cable 816. The imaging catheter 812 can
include an
imaging assembly 820 having an imaging device 822 for generating imaging
signals
corresponding to objects in the field of view thereof. The imaging device is
typically an optical
sensor and can be a camera or an optical fiber. The imaging assembly may also
include elements
such as LEDs for illuminating or providing lighting to the field of view. The
imaging assembly
can further comprise one or more components such as a processor, a memory
device to facilitate
capture, transformation of the image of the field of view into imaging
signals, and transmission
of the imaging signals. The imaging device generates and transmits the imaging
signals to the
console 14 through cable 816 or wirelessly through any suitable communications
procedure or
protocol. Other cables may be used without departing from the scope of the
present invention.
[0138] The console receives and converts the imaging signals from the imaging
assembly and
presents the images on a display 830 in a housing 832 of the console. As
exemplarily shown in
FIG. 47, the console can also include a power switch 834 for selectively
energizing the console.
Other consoles may be used without departing from the scope of the present
invention. The
display preferably responds to one or more user input or commands, e.g.,
double tapping the
display, to activate and present one or more menus offering a plurality of
selections for operating
the console and imaging assembly. For example, one of the user inputs causes
the display to
present a reference menu as illustrated in FIG. 47.
[0139] Selections or entries 840a, 840, and 840c may be presented for
selection and reviewing
stored images of prior procedures performed using the system. As illustrated
in FIG. 47, the
console can be configured to include and provide a selection 42 titled,
"REFERENCE LIBRARY", which calls from memory a reference menu including menu
items
corresponding to a library or plurality of reference materials stored in the
console memory. For
example, the library of reference materials, which may include one or more
group of reference
materials, may include, for example, photographs, video recordings, audio
recordings, diagrams,
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animations, and/or text. The reference materials provide any one or more of
information about
anatomy, preparing a patient, preparing the imaging catheter for use, placing
the imaging catheter
in a patient, console preparation, console operation, console features,
overall system operation,
overall system features, and/or contact information such as addresses and/or
phone numbers that
may be used to access further help. Other selections or information that may
be provided in the
menu may be viewed by manipulating a scroll bar 844 positioned proximate
selections 840a-
840c and 842 on the display. In some embodiments, command, instruction, and/or
navigation
icons such as a back icon 850 and a view icon 852, can be provided along the
bottom of the
display.
[0140] In some embodiments (not shown), it is envisioned that the display 30
simultaneously
presents the reference menu 42 with images generated from the imaging signals
provided by the
imaging device. In other embodiments (not shown), it is envisioned that the
display 30 presents
the reference menu upon sensing a unique input, such as when a user touches
the display twice
within a preselected period of time. In yet other embodiments (not shown), it
is envisioned that
the display 30 presents an icon that presents the reference menu when selected
by the user.
Alternatively, the console 14 may include a button that may be pressed to
cause the display 30 to
present the reference menu.
[0141] In some embodiments, the console may present reference materials, such
as those
identified above, simultaneously with the images generated from the imaging
signal. For
example, as exemplarily illustrated in FIG. 29, a photograph of a typical
anatomical feature or
marker may be displayed on a portion of the display and live video generated
from imaging
signals transmitted by the imaging assembly may be displayed on another
portion of the display.
Thus, a user can identify where the imaging assembly is positioned in the
patient by comparing
the live video generated from the imaging signals transmitted by the imaging
assembly against a
reference photograph including anatomical feature or anatomical landmark.
Further, as
exemplarily shown in FIG. 31, the reference materials, such as a photograph
864, may be
presented on the display with one or textual references or indicia 866,
providing identifying
information or description, such as the names of the target anatomical feature
or anatomical
marker. The anatomical marker can be any one of a bronchus, a larynx, a
tracheal ring, a cardia,
a pyloric sphincter, and a pyloric orifice. As is further apparent by a
comparison of FIG. 29 and
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FIG. 31, the visual reference materials may be presented on only a portion of
the display or on
the entire display. When only a portion of the display is used to present
visual reference
materials as shown in FIG. 3, other indicators, such as icons 420, 422, 424,
426, and 428) and
one or more visual status identifiers 872a, 872b, and 872c may be shown on the
display.
Alternatively, as shown in FIG. 31, when the entire display is used to present
visual reference
materials, any one or more of icons 420, 422, 424, 426, and 428 and any one or
more of visual
status identifiers 772a-872c may be presented over the visual reference
materials. In other cases,
for example, the console can be operated by selecting a menu to display a copy
of a photograph
of a representative bronchus, as exemplarily presented in FIG. 49A; a copy of
a photograph of a
representative stomach with stomach folds, as exemplarily presented in FIG.
49B; and a copy
of a photograph of a representative tracheal rings, as exemplarily presented
in FIG. 49C, without
any identifiers or indicia.
[0142] The reference materials may also present instructive guidance. For
example, the console
can be configured to be operated to display a schematic illustration including
contrasting correct
and incorrect paths, as shown in FIG. 48. Further embodiments contemplate the
simultaneous
presentation of the schematic illustration of FIG. 48 adjacent real-time or
live video images from
the imaging apparatus to provide further guidance during use.
[0143] In some embodiments of the invention, the materials may be located or
stored in a
directory having a name corresponding to the particular reference material.
For example,
portions of a system operation manual could be stored in a directory entitled,
"SYSTEM OPERATION MANUAL". In some embodiments, the reference material may be
saved as read-only files, ensuring the content remains unchanged.
Alternatively, oral comments,
marginalia, and other annotations may be entered into reference materials and
stored as a new
file, with or without particular association or links to any of one or more of
each of the reference
materials in the reference library.
[0144] It is further envisioned that reference material files could be
modified when updating
software. Thus, each software release could also be used to update and improve
reference
materials for the system. In other cases, the system that has been used in the
field can be sent by
a user to a servicing, manufacturing, or repair facility whereat the
additional reference
information may be included in the memory, with or without removing any stored
or existing
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reference material, or portions thereof In other cases, the received system at
the servicing,
manufacturing, or repair facility may be updated by having memory components
therein
replaced, thereby providing updated reference materials.
[0145] Depending upon the particular procedure for which the imaging catheter
system is used,
the system may also include, for example, a conventional feeding tube assembly
having a feeding
tube for delivering enteral feeding liquid to a patient. A generally
conventional feeding tube
includes a feeding passage extending between an inlet and an outlet. The
imaging catheter may
be positioned adjacent the outlet of the feeding tube for generating imaging
signals
corresponding to a particular portion of the patient's alimentary canal, e.g.,
a patient's stomach.
In some cases, it would be desirable that the imaging assembly is sealed from
the feeding passage
of the feeding tube to inhibit enteral feeding liquid in the feeding passage
from entering the
imaging assembly, causing potential damage. In use, reference material, such
as video,
photographs, or diagrams, is periodically accessed on the display to verify
proper placement of
the medical instrument in the patient.
[0146] One or more further aspects of the invention can be directed to
computer-readable media
accessible by the console and having stored thereon a plurality of data
structures corresponding
to reference materials in a reference library, wherein each of the reference
materials can be
audiovisual information including, for example, photographs, video files,
audio files, and
combinations thereof, as well as textual or graphical information including,
for example,
diagrams, sketches, and textual information. The reference materials of the
reference library in
the computer-readable media provides information regarding at least one of an
anatomical
reference or feature or anatomical landmark, operating instructions of at
least one of the imaging
catheter, the console, the feeding tube, and contact information regarding at
least one of the
system, the feeding tube, and the console. Still further aspects can be
directed to providing the
computer-readable media having stored thereon the plurality of data structures
including the
reference library of reference materials, as well as updating the reference
library of reference
materials by adding additional to or replacing the existing reference
materials with updated or
revised reference materials. Non-limiting examples of computer-readable media
include memory
devices and can be optical-based and magnetic-based media, any of which can be
erasable,
programmable, or permanent.
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[0147] Any of the reference materials of the reference library can be stored
in any format or file
type such as, but not limited to aiff, way, xmf, fits, tiff, avi, asf, wma,
wmv, 3gp, fly, f4v, iff, jpg,
bmp, mpeg, mp4, rm, ogg, pdf, rtf, and txt, any of which can be in any of
native and compressed
forms. Any of such reference materials can be protected from modification or
deletion in the
field by a healthcare provider but can be modified, revised or deleted by
qualified technician at,
for example, a repair or manufacturing facility, or at a servicing facility.
[0148] As explained, the console may be configured to recognize a plurality of
classes, i.e.,
statuses, of users, and to limit operations that may be performed by the
console as a function of a
class associated with each user. For example, the console may be configured to
recognize four
classes of users: operators, administrators, approval, and maintenance.
Depending upon the user
class, the reference menus may be changed to adapt to the skill and needs of
the user. For
example, the console can be configured to authorize administrator class users
to create or
establish user accounts or other operator accounts, along with respectively
associated data
storage substructures, and to view video data. The console may be configured
to authorize
approval class users to view video data and to annotate approval data onto the
video data. The
console can be configured to authorize maintenance class users to perform
maintenance functions
to the console such as software updates and time adjustments. The console
could be
programmed to only authorize maintenance class users to operate the console if
no patient data is
stored on the console.
[0149] Having described aspects of the invention in detail, it will be
apparent that modifications
and variations are possible without departing from the scope of the invention
as defined in the
claims. As various changes could be made in the above constructions, products,
and methods
without departing from the scope of aspects of the invention, it is intended
that all matter
contained in the above description and shown in the accompanying drawings are
illustrative and
not in a limiting sense. For example, the simultaneous display of reference
anatomical markers
may involve progressively showing an expected next or sequential marker after
an operator or
user has indicated that a current reference anatomical marker has been
identified by capturing
and optionally annotating a photographic image from the imaging system. When
introducing
elements of aspects of the invention or the embodiments thereof, the articles
"a," "an," "the," and
"said" are intended to mean that there are one or more of the elements. The
terms "comprising,"
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"including," and "having" are intended to be inclusive and mean that there may
be additional
elements other than the listed elements.
[0150] What is claimed is:
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