U.S. patent application number 13/347787 was filed with the patent office on 2012-07-05 for assembly with imaging electronics.
This patent application is currently assigned to Tyco Healthcare Group LP. Invention is credited to Robert Allyn, Glen Branconier, William J. Byrd, Michael C. Dorsey, Robert B. Gaines, Michael D. Hudspeth, Thomas G. Lewis.
Application Number | 20120172665 13/347787 |
Document ID | / |
Family ID | 45807343 |
Filed Date | 2012-07-05 |
United States Patent
Application |
20120172665 |
Kind Code |
A1 |
Allyn; Robert ; et
al. |
July 5, 2012 |
Assembly with Imaging Electronics
Abstract
A catheter with an imaging assembly is disclosed. The catheter
is used with a console for viewing and/or storing images obtained
from the catheter. The catheter may be a feeding tube assembly. The
imaging assembly on the feeding tube assembly allows a user to
confirm placement of the feeding tube assembly in the patient's
alimentary canal.
Inventors: |
Allyn; Robert; (Pacific,
MO) ; Gaines; Robert B.; (Lake Saint Louis, MO)
; Lewis; Thomas G.; (O'Fallon, IL) ; Dorsey;
Michael C.; (Edwardsville, IL) ; Byrd; William
J.; (Arnold, MO) ; Hudspeth; Michael D.;
(Arnold, MO) ; Branconier; Glen; (North Attleboro,
MA) |
Assignee: |
Tyco Healthcare Group LP
Mansfield
MA
|
Family ID: |
45807343 |
Appl. No.: |
13/347787 |
Filed: |
January 11, 2012 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13228075 |
Sep 8, 2011 |
|
|
|
13347787 |
|
|
|
|
61380985 |
Sep 8, 2010 |
|
|
|
61482080 |
May 3, 2011 |
|
|
|
Current U.S.
Class: |
600/112 ;
600/109 |
Current CPC
Class: |
A61B 1/04 20130101; A61B
1/0607 20130101; A61B 1/0005 20130101; A61B 1/00137 20130101; A61B
1/053 20130101; A61B 1/00119 20130101; A61B 5/0084 20130101; A61B
1/00041 20130101; A61B 5/6852 20130101; A61B 1/0676 20130101; A61B
5/742 20130101; A61J 15/0026 20130101; A61B 1/0002 20130101; A61B
1/051 20130101; A61B 1/2736 20130101; A61B 1/00059 20130101; A61B
5/0013 20130101; A61J 15/00 20130101; A61B 1/05 20130101; A61J
15/008 20150501; A61B 1/00045 20130101; A61B 1/00114 20130101; A61J
15/0069 20130101; A61J 15/0003 20130101; A61B 1/0684 20130101; A61B
1/005 20130101; A61J 15/0073 20130101; A61B 1/2676 20130101 |
Class at
Publication: |
600/112 ;
600/109 |
International
Class: |
A61B 1/012 20060101
A61B001/012; A61B 1/005 20060101 A61B001/005; A61B 1/04 20060101
A61B001/04 |
Claims
1.-7. (canceled)
8. A feeding tube assembly comprising: 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 adjacent the second longitudinal end of the tube in fluid
communication with the feeding passage, the inlet adaptor
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 including an imaging
device, the imaging assembly configured for generating and
transmitting imaging signals indicative of images of the alimentary
canal of a subject, wherein 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 proximate the imaging assembly and in fluid communication
with the feeding passage for delivering enteral feeding liquid to
the subject; and a console connector communicatively connected to
the imaging assembly, the console connector configured for use in
connecting to the imaging assembly to a console to allow
transmission of the imaging signals to the console.
9. The feeding tube assembly of claim 8, wherein the longitudinal
axis of the tube passes through the feeding passage.
10. The feeding tube assembly of claim 9, further comprising a
signal transmission component extending longitudinally along the
tube from the imaging assembly to the console connector to provide
communication between the imaging assembly and the console
connector.
11. The feeding tube assembly of claim 10, wherein the tube
includes a tube wall having an interior surface defining the
feeding passage and an exterior surface defining the exterior
surface of the tube, wherein the signal transmission component is
received in a signal transmission passage in the tube wall and
sealed from the fluid passage.
12. The feeding tube assembly of claim 11, wherein the signal
transmission component is embedded in the tube wall.
13. The feeding tube assembly of claim 11, wherein the signal
transmission component comprises a plurality of signal lines.
14. The feeding tube assembly of claim 13, wherein the signal lines
consist of a power supply line, a ground line, and a pair of
differential signal lines.
15. The feeding tube assembly of claim 8, further comprising an
imaging assembly connector interconnecting the feeding tube and the
imaging assembly, wherein the imaging assembly connector defines
the feeding outlet.
16. The feeding tube assembly of claim 15, wherein the imaging
assembly connector is more rigid than the feeding tube.
17. The feeding tube assembly of claim 8, wherein the imaging
assembly comprises a deformable circuit element, wherein the
imaging device and a light source are mounted on the deformable
circuit element.
18. The feeding tube assembly of claim 17, wherein the deformable
circuit element includes a planar longitudinal portion extending
parallel to the longitudinal axis of the feeding tube, and a planar
transverse portion extending transverse to the longitudinal axis of
the feeding tube, wherein the imaging device and the light source
are mounted on the transverse portion of the deformable circuit
element.
19. The feeding tube assembly of claim 17, wherein the deformable
circuit element comprises a proximal end secured to the feeding
tube, a distal end remote from the feeding tube, the proximal end
and the distal end defining a longitudinal axis of the deformable
circuit element therebetween, a camera mounting surface oriented
transversely to the longitudinal axis of the deformable circuit
element, a light source mounting surface oriented transversely to
the longitudinal axis of the deformable circuit element and to the
camera mounting surface, wherein the imaging device is mounted on
the camera mounting surface, and the light source is mounted on the
light source mounting surface at a position that is distal from the
imaging device.
20. The feeding tube assembly of claim 17, wherein the deformable
circuit element has a proximal end adjacent the feeding tube, a
distal end remote from the feeding tube, and a longitudinal axis
extending between the proximal and distal ends, wherein the
deformable circuit element includes a camera mounting portion, on
which a camera is mounted, extending transverse to the longitudinal
axis of the deformable circuit element, and a light source mounting
portion being laterally disposed relative to the camera mounting
portion, wherein the light source is mounted on the light source
mounting portion such that the light source is laterally disposed
relative to the camera.
21. The feeding tube assembly of claim 8, wherein the imaging
assembly is sized and shaped for nasogastric intubation.
22. The feeding tube assembly of claim 8, wherein the console
connector includes an electronic memory component having feeding
tube data relating to the feeding tube assembly written thereon,
wherein the electronic memory component and the feeding tube data
are accessible by an external microprocessor.
23. The feeding tube assembly of claim 22, wherein the console
connector includes a printed circuit board (PCB) having an edge
connector adapted to connect to an interface cable, wherein the
electronic memory component is mounted on the PCB and electrically
connected to the edge connector.
24. The feeding tube assembly of claim 22, wherein the feeding tube
data includes a predefined identifier associated with the connector
assembly that distinguishes the feeding tube assembly from other
feeding tube assemblies.
25. The feeding tube assembly of claim 23, wherein the feeding tube
data includes a date of manufacture of the feeding tube
assembly.
26. The feeding tube assembly of claim 8, wherein the console
connector is intermediate the inlet adaptor and the imaging
assembly.
27. The feeding tube assembly of claim 26, wherein the console
connector extends laterally outward from the feeding tube.
28. The feeding tube assembly of claim 26, wherein the feeding
passage passes through the console connector.
29. The feeding tube assembly of claim 8, wherein the imaging
assembly includes a rigid-flex circuit, wherein the imaging device
is mounted on the rigid-flex circuit.
30.-76. (canceled)
Description
[0001] The present application claims priority to U.S. Provisional
Application Ser. Nos. 61/482,080, filed May 3, 2011, and
61/380,985, filed Sep. 8, 2010, each of which is incorporated
herein by reference in its entirety for all purposes.
BACKGROUND
[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.
[0004] These x-ray imaging procedures are generally expensive and
time consuming. Additionally, a patient often uses a feeding tube
for a substantial length of time. Thus, the x-ray imaging
procedures must be repeated periodically to ensure that the feeding
tube has not moved (i.e., migrated).
SUMMARY
[0005] 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.
[0006] 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.
[0007] 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 includes an imaging device
and 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 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.
[0008] 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.
[0009] 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 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.
[0010] 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.
[0011] 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 and a current image from image data currently
being received by the console from the imaging assembly.
[0012] This Summary is provided to introduce a selection of
concepts in a simplified form that are further described below in
the Detailed Description. This Summary is not intended to identify
key features or essential features of the claimed subject matter,
nor is it intended to be used as an aid in determining the scope of
the claimed subject matter.
[0013] Other features will be in part apparent and in part pointed
out hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] 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;
[0015] 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;
[0016] 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;
[0017] 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;
[0018] 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;
[0019] 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;
[0020] 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;
[0021] 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;
[0022] 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;
[0023] 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;
[0024] 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;
[0025] FIG. 11 is a block diagram of the flex circuit assembly in
FIG. 7, in accordance with one or more aspects of the
invention;
[0026] 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;
[0027] 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;
[0028] 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;
[0029] FIG. 16 is a block diagram of the flex circuit assembly, in
accordance with one or more aspects of the invention;
[0030] FIG. 17 is a block diagram of the flex circuit assembly, in
accordance with one or more aspects of the invention;
[0031] FIG. 18 is a block diagram of an exemplary feeding tube
system, in accordance with one or more aspects of the
invention;
[0032] FIG. 19 is a flow diagram showing an exemplary graphical
user interface screen flow, in accordance with one or more aspects
of the invention;
[0033] 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;
[0034] 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;
[0035] 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;
[0036] 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;
[0037] 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;
[0038] 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;
[0039] 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;
[0040] 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;
[0041] 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;
[0042] 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;
[0043] 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;
[0044] FIG. 41 is a schematic illustration showing an imaging
assembly, in accordance with one or more aspects of the
invention;
[0045] 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;
[0046] FIG. 43 is a schematic illustration showing an interface
cable, in accordance with one or more aspects of the invention;
[0047] 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
[0048] 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.
[0049] Corresponding reference characters indicate corresponding
parts throughout the drawings.
DETAILED DESCRIPTION
[0050] 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. In general, the
illustrated nasogastric feeding tube assembly 10 can be configured
to provide digital images of an alimentary canal, or a portion(s)
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., 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., balloon catheter or other type of heart catheter).
[0051] 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 (i.e., a distal end) and an open
second longitudinal end (i.e., 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 and
transmitting real time images (e.g., 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.
[0052] 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.
[0053] 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.
[0054] 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 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.
[0055] 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.
[0056] 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.
[0057] 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 take on other shapes, sizes and configurations, or may be
entirely omitted, without departing from the scope of the
invention.
[0058] 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.
[0059] 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 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.
[0060] 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 take on other shapes, sizes and
configurations (or may be entirely omitted) without departing from
the scope of the invention. Moreover, the imaging assembly 18 may
be secured to the tube 12 in other ways without departing from the
scope of the present invention.
[0061] 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.
[0062] 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. Generally
speaking a flex circuit includes a deformable circuit element and
components mounted on the deformable circuit element. The
deformable circuit element may be a flat (at least prior to being
deformed) substrate that can be bent or otherwise deformed, and
which also 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 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 substantially 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.
[0063] 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
components of the imaging assembly 18 do not depart from the scope
of the present invention and may be implemented as variant
embodiments thereof. For example, in another embodiment, the flex
circuit assembly 60 may be replaced with a rigid printed circuit
board (PCB).
[0064] 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.
[0065] 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.
[0066] 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 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.
[0067] 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.
[0068] 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 affects the quality of the image generated by the
imaging assembly 18. In the exemplarily embodiment, the protruding
portion of 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.
[0069] 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.
[0070] 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 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.
[0071] FIG. 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. FIGS. 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 5 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
(i.e., 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
ISL9016IRUJCZ-T available from Intersil Corporation, Milpitas,
Calif.) 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, Calif. However, other cameras or image
sensors may be used without departing from the scope of the
invention.
[0072] The oscillator 206, such as an 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.
[0073] 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.
[0074] 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 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., I.sup.2C 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.
[0075] 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.
[0076] 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
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.
[0077] 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.
[0078] 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.
[0079] 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, 5V, and a ground line, GND) 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). 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.
[0080] 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.
[0081] 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
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.
[0082] 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. And, fewer conductors
reduce the likelihood of inadvertently switching lines and
incorrectly connecting them during assembly.
[0083] 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.
[0084] 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. It is understood that the PCB 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.
[0085] 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.
[0086] 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.
[0087] 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 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.
[0088] 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 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.
[0089] 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.
[0090] 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 a valid
information, such as an acceptable code or an acceptable predefined
identifier. Also, 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 one or
more predefined identifying information, e.g., a predefined
identifier, that can be utilized by the console before or during
operation thereof.
[0091] 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.
[0092] 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 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.
[0093] 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.
[0094] FIGS. 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.
[0095] As illustrated, a user interface screen prompts a user to
indicate whether the user is the very first user of the console 23
(hereinafter "initial user"), or whether the user has already been
associated 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.
[0096] 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.
[0097] In one embodiment, the console 23 is 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 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.
[0098] 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 (i.e., 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 (deleting
patient data, user data, and device data) or erasing the console
(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.
[0099] 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.
[0100] 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 wrist band 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 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.
[0101] 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.
[0102] 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. 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.
[0103] 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.
[0104] 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).
[0105] 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#.img, wherein [0106] DATE=the
current date (e.g., yyymmdd) set to the console via the "Date/Time"
feature [0107] SUD-SN=single use device serial number (e.g., the
identifier retrieved by the console 23 from the console connector
22) [0108] PT-NAME=patient name as entered by the user via the
patient information user interface screen [0109] PT-ID=patient
identifier as entered by the user via the patient information user
interface screen [0110] TIME=the current time (e.g., hhmmss) set to
the console via the "Date/Time" feature [0111] 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/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 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., touch, click,
etc) 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 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., touch, click,
etc) 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 [0119] USERNAME=the username of the current user as entered
in the approver user interface screen [0120] DATE=the current date
(e.g., yyymmdd) set to the console via the "Date/Time" feature
[0121] TIME=the current time (e.g., hhmmss) set to the console via
the "Date/Time" feature
[0122] 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.
[0123] 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, 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.
[0124] 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.
[0125] 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 image(s) 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.
[0126] 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, 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.
[0127] 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.
[0128] 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.
[0129] 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.
[0130] 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%.
[0131] 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.
[0132] 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 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).
[0133] 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.
[0134] 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.
[0135] 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 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.
[0136] 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.
[0137] In the illustrated embodiment, first interface connector 744
can include an imaging signal buffer component 750 (e.g., an
I.sup.2C buffer component) which drives imaging signals (e.g.,
I.sup.2C 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 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.
[0138] 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," "including," and "having" are intended to be
inclusive and mean that there may be additional elements other than
the listed elements.
[0139] Having described aspects of the invention in detail, it will
be apparent that modifications and variations are possible without
departing from the scope of aspects of the invention as defined in
the appended 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 shall be interpreted as illustrative and not in a limiting
sense.
* * * * *