U.S. patent application number 17/161969 was filed with the patent office on 2021-06-17 for four-dimensional analysis system, apparatus, and method.
The applicant listed for this patent is Edgewell Personal Care Brands, LLC. Invention is credited to Alexander O'Connor, Richard Timmers.
Application Number | 20210177675 17/161969 |
Document ID | / |
Family ID | 1000005419624 |
Filed Date | 2021-06-17 |
United States Patent
Application |
20210177675 |
Kind Code |
A1 |
O'Connor; Alexander ; et
al. |
June 17, 2021 |
FOUR-DIMENSIONAL ANALYSIS SYSTEM, APPARATUS, AND METHOD
Abstract
A system for measuring fluid absorption and retention properties
of various samples having one or more materials, layers and/or
articles. The system includes an optically or radiographically
transparent fixture. The system enables measuring voxels having a
grayscale value that demonstrate a difference in fluid densities
and thereby enable the study of fluid flow and movement within
and/or amongst various materials and articles in real time.
Inventors: |
O'Connor; Alexander;
(Cincinnati, OH) ; Timmers; Richard; (Saddle
Brook, NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Edgewell Personal Care Brands, LLC |
Chesterfield |
MO |
US |
|
|
Family ID: |
1000005419624 |
Appl. No.: |
17/161969 |
Filed: |
January 29, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16227090 |
Dec 20, 2018 |
10940058 |
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17161969 |
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15354412 |
Nov 17, 2016 |
10201463 |
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16227090 |
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62256405 |
Nov 17, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01N 23/046 20130101;
A61F 2013/8488 20130101; A61F 13/84 20130101 |
International
Class: |
A61F 13/84 20060101
A61F013/84; G01N 23/046 20060101 G01N023/046 |
Claims
1. An apparatus configured to represent fluid associated with a
personal care product, the system comprising: a sample of said
personal care product; a fluid source containing a fluid; a syringe
pump operatively connected to said fluid source, said syringe pump
controlling fluid flow; a line operatively connected to said fluid
source, said line having a line end, said line and said line end
comprising a low density material having a density sufficiently
distinct from said sample; a platform movable about at least one
axis, a fixture having an upper region, a middle region and a lower
region, said fixture comprising a radiographically transparent
material, said fixture further comprising: a bore positioned within
said fixture to receive said line; a first arm defining an opening
in communication with said bore, said opening permitting access to
an interior volume of said fixture; said first arm being hingedly
connected to said fixture thereby permitting said first arm to move
about an axis thereby enlarging said opening and revealing said
interior volume; and a wrapper positioned within said fixture, said
wrapper having an opening at a first end in communication with said
line end, said wrapper substantially encompassing said sample such
that fluid entering said wrapper through said line end is
substantially contained within said wrapper thereby creating a
barrier between said sample and a surface defining said interior
volume, said wrapper comprising a low-density material that is
sufficiently distinct from said sample; wherein said fixture exerts
a force of between about 0.1 psi and 5.0 psi.
2. The apparatus of claim 1, wherein said fixture further comprises
a second arm, said second arm being hingedly connected to said
fixture thereby permitting said second arm to move about a second
axis thereby enlarging said opening and revealing said interior
volume.
3. The apparatus of claim 1, wherein said fixture further comprises
a retaining mechanism to assist in holding said personal care
product.
4. The apparatus of claim 1, wherein said fluid is one of water,
saline, menses, blood, synthetic menses, glycerin, and combinations
thereof.
5. The apparatus of claim 1, wherein said fixture is at least
partially visually transparent.
6. An apparatus configured to represent fluid associated with a
personal care product, the system comprising: a sample of said
personal care product; a fluid source containing a fluid; a syringe
pump operatively connected to said fluid source, said syringe pump
controlling fluid flow; a line operatively connected to said fluid
source, said line having a line end, said line and said line end
comprising a low density material other than metal having a density
sufficiently distinct from said sample; a platform movable about at
least one axis, a fixture comprising a radiographically transparent
material, said fixture further comprising: a first region
connectable to said platform; a second region connectable to said
first region, said second region simulating a second region of said
human body, said second region having at least one contoured
surface upon which to position said sample; a third region
connectable to said second region; wherein said first region and
said third region simulate an additional region of said human body
and/or support said second region.
7. The apparatus of claim 6, wherein said second region further
comprises a barrier that provides a barrier between said sample and
a said contoured surface, said barrier comprising a low-density
material that is sufficiently distinct from said sample.
8. The apparatus of claim 6, wherein said fixture exerts a force of
between about 0.25 psi and 5.0 psi.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/227,090, filed Dec. 20, 2018, which is a
continuation application of U.S. patent application Ser. No.
15/354,412, filed Nov. 17, 2016, now U.S. Pat. No. 10,201,463,
issued on Feb. 12, 2019, claims the benefit of priority to U.S.
Provisional Patent Application Ser. No. 62/256,405 filed on Nov.
17, 2015, the contents of which are incorporated by reference
herein.
BACKGROUND
[0002] Studies and research have been undertaken to determine the
efficacy of personal care products. For example, in the context of
feminine hygiene products, research has been performed to determine
the effectiveness of the products in absorbing fluid.
[0003] The quality of the results that are obtained in connection
with the research are influenced by the quality of the test system,
apparatus, and methodology that are used. For example, due to the
complexity of the imaging technology (e.g., computed tomography
(CT) scanning) that is used as well as variations in the
products/samples that are being analyzed, it is difficult to
determine a grayscale value that best represent those volumetric
pixels (voxels) of reconstructed data sets that correspond to fluid
entering a given sample. In the context of medical imaging, CT
scans can be low resolution and fail to recreate real-time
conditions despite successive scans or a series of scans. Further
still, in vivo set-ups can be costly and require significant
amounts of time to, inter alia, organizing subject populations,
creating a test protocol, scheduling the scans and analyzing the
results. Accordingly, there is uncertainty that is introduced that
is difficult, if not impossible, to account for. Furthermore, due
to delays between the capturing of the image and when the
associated data set becomes available, events such as an
advancement of a fluid-front in association with the sample may be
missed or unaccounted for.
SUMMARY OF THE PRESENT DISCLOSURE
[0004] The present disclosure provides a system for determining
real-time fluid dynamics within or near a device. The system
includes a fixture that simulates an in vivo set-up via at least
one characteristic. The fixture simulates bodily pressure exerted
against a device. The device is a consumer product such as a
hygiene device, an implement, and/or a medical device. The device
is an internally worn device or an externally worn (or externally
manipulated) device. In some embodiments, the device is dynamic in
that it changes in shape, configuration and/or other mechanical
properties upon implementation (i.e. upon contacting the body,
fluid and/or by its design). In some embodiments, the device is
dynamic due to other forces exerted upon it. Such forces could be
bodily, such as pressure exerted by the body cavity against an
internally worn device. Such forces could be from other objects,
such as garments worn adjacent the body, pressure exerted by a bed
or a chair when a person is lying or sitting, and/or limbs
directing the device's movement and/or affecting the device's
configuration.
[0005] The fixture is a somewhat simple structure as exemplified in
FIGS. 1-4. The fixture accommodates a device (herein referred to as
the "sample" or "test sample").
[0006] The fixture is a more complex structure as shown in FIGS.
5-7. Such fixtures include multiple regions that can be fixed and
thus relative movement amongst these regions is limited, or these
regions can be separate, attachable and/or movable with respect to
each other to create a dynamic in vivo-esque profile.
[0007] The fixture is a further refined structure as shown in FIGS.
8a-8c. Such fixtures are formed from human body scans or
measurements, both internal and external. Such fixtures are static
and/or dynamic (i.e. the one or more leg regions are able to move
with respect to the torso or pelvic region).
[0008] The fixture is radiographically transparent or translucent
("radiotransparent") such that a scanning means (such as CT or
micro-CT) can be employed. Optionally, the fixture is visually
transparent. The fixture is attached to a platform that permits
rotation about at least one axis, thereby permitting imaging of the
sample in real time. The fixture can move about multiple axes to
generate different views and/or different configurations to
replicate the position and functionality of the sample of the
device in simulated conditions. Movement of a fixture in at least
one direction, plane and/or along an axis other than to generate an
image, can be done with a cadence that simulates in vivo
interaction and motion amongst body parts and the device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The present disclosure is illustrated by way of example and
not limited in the accompanying figures in which like reference
numerals indicate similar elements.
[0010] FIG. 1 illustrates a diagrammatic representation of one
embodiment of the present disclosure's test fixture apparatus.
[0011] FIG. 2 illustrates a diagrammatic representation of one
embodiment of the present disclosure's test fixture apparatus.
[0012] FIG. 3 illustrates a diagrammatic representation of one
embodiment of the present disclosure's test fixture apparatus.
[0013] FIG. 4 illustrates a diagrammatic representation of one
embodiment of the present disclosure's test fixture apparatus.
[0014] FIG. 5 illustrates a diagrammatic representation of one
embodiment of the present disclosure's test fixture apparatus.
[0015] FIG. 6 illustrates a diagrammatic representation of one
embodiment of the present disclosure's test fixture apparatus.
[0016] FIG. 7 illustrates a diagrammatic representation of one
embodiment of the present disclosure's test fixture apparatus.
[0017] FIG. 8a illustrates a diagrammatic representation of one
embodiment of the present disclosure's test fixture apparatus.
[0018] FIG. 8b illustrates a diagrammatic representation of a back
view of one embodiment of the present disclosure's test fixture
apparatus.
[0019] FIG. 8c illustrates a diagrammatic representation of a side
view one embodiment of the present disclosure's test fixture
apparatus.
[0020] FIG. 9 illustrates a diagrammatic representation of a side
view one embodiment of the present disclosure's test fixture
apparatus.
[0021] FIG. 10 illustrates a computing system architecture.
[0022] FIG. 11 illustrates a system that is configured to represent
a fluid or fluid flow associated with a sample.
[0023] FIGS. 12A-12E illustrate a flow chart of an exemplary method
for representing a fluid or fluid flow associated with a
sample.
[0024] FIG. 13 illustrates a fixture in accordance with aspects of
this disclosure.
[0025] FIG. 14 illustrates a flow chart of an exemplary method for
representing a fluid or fluid flow associated with a sample based
on the use of a reference.
DETAILED DESCRIPTION
[0026] It is noted that various connections are set forth between
elements in the following description and in the drawings (the
contents of which are included in this disclosure by way of
reference). It is noted that these connections are general and,
unless specified otherwise, may be direct or indirect and that this
specification is not intended to be limiting in this respect. A
coupling between two or more entities may refer to a direct
connection or an indirect connection. An indirect connection may
incorporate one or more intervening entities.
[0027] Aspects of the disclosure are directed to systems,
apparatuses, and methods for performing an analysis on one more
samples. A sample 204 may be associated with a device such as a
personal care product, including hygiene products, medical devices,
including diapers and feminine hygiene products worn internally
and/or externally (e.g., a pledget, an applicator, a menstrual cup,
a napkin, a pad, a liner, a pessary, a suppository etc.) for
menstrual and/or incontinence purposes. As for suppositories, the
disclosure demonstrates the dissolution and/or transition of a
suppository as it enters the body and chemically interacts with the
body, thereby inducing a change in the suppository's state or
transport of the material contained within or delivered by the
suppository. In some embodiments, a fluid may be
injected/introduced to the sample 204, and an analysis may be
performed to determine/characterize how the fluid flows in/through
the sample 204. For example, if a flow rate of fluid 246 introduced
to the sample 204 is a constant, a grayscale value that best
represents volumetric pixels (voxels) of a reconstructed data set
that correspond to the fluid 246 entering the sample 204 can be
determined heuristically. As one skilled in the art would
appreciate, a grayscale value may serve as a representation of an
intensity, ranging from black to white, of a voxel. A voxel may be
associated with a three-dimensional data structure defined by a
grayscale value, a length, a width, a height, and a relative
position in space.
[0028] Referring now to FIG. 1, a fixture 202 is shown. The fixture
202, as at least a part of system 200, may be used to
represent/simulate a fluid flow associated with one or more samples
204.
[0029] The fixture 202 may be configured to retain a sample 204
(e.g., a personal care product) that is to be subjected to an
analysis in accordance with aspects of the disclosure. The
retention of the sample 204 may be facilitated by the fixture 202
and/or use of retaining mechanism 206. The retaining mechanism 206
may be made of foam or other material such as materials similar to
garments, underwear and/or beds, chairs, etc. . . . . The retaining
mechanism 206 may also have a hydrophobic layer or portion such as
a plastic, film or silicone. The retaining mechanism 206 may
exhibit properties, such as pressure, that simulate properties of
tissues such that the in vitro set-up mimics an in vivo set-up. The
retaining mechanism 206 may include a bore 208 for holding the
sample 204 that is in communication with a fluid line 211,
particularly the fluid line end 211a. In some embodiments, fixture
202 is also a retaining mechanism 206. Bore 208 may be generally
cylindrical and/or have an arcuate or varying geometry. In some
embodiments, fixture 202 has a recess 208a that further assists in
retaining sample 202. Recess 208a is in concert with bore 208 and
creates a slightly raised lip such that sample 204 can be more
easily positioned within or adjacent to fixture 202. Bore 208 can
be positioned in varying configurations and/or orientations within
fixture 202 such that fluid flow can enter or surround sample 204
as per known gravitational forces.
[0030] Fixture 202 has an upper region 228 and a lower region 230,
and as shown more easily in FIG. 3, a middle region 229. As shown
in FIGS. 1-4, the upper, lower and middle regions can have a
variety of configurations and purposes, depending on the set-up and
predetermined goals of the study. Fixture 202 has a bore 208 and an
opening 231. Bore 208 provides access for sample 204 and/or a line
211 transmitting fluid into, around or proximal to the sample 204.
Opening 231 permits further access to the interior volume 234 of
fixture 202, permitting easier insertion and/or removal of sample
204 and other items described throughout the present disclosure. To
facilitate opening 231 and thusly access to the interior volume
234, fixture 202 has one or more hinges 236 that permit an arm 238
of fixture 202 to deflect and/or move about a pivot point, axis,
and/or plane. Said differently, arm 238 is hingedly connected to
fixture 202 about one or more hinges 236. Interior volume 234 is
defined by interior surface 235.
[0031] The bore 208 has a size similar to that of a predetermined
sample 204. For instance, known tampons have a diameter of between
about 0.48 inches to about 0.63 inches (or about 12 mm to about 16
mm) and a length of about 1.25 to about 3 inches. Other known
internally worn menstrual devices such as cups have a diameter of
about 1 inch while others have a diameter of up to 3 inches. As
such, bore 208 is sized similarly to samples 204 of these devices.
Alternatively, bore 208 is sized to emulate the in vivo
environment. By way of example, the bore 208 is suitably configured
to receive an internally worn hygiene device, such as a tampon, and
as such, is sized and shaped similarly to any known vaginal cavity
anatomy and/or mean, median, mode or otherwise representative
dimensions.
[0032] FIGS. 1-4 exemplify a bore 208 generally disposed along the
central vertical 240 axis of fixture 202, but can be in other
locations depending on the configuration of the fixture 202. For
instance, FIGS. 5-7 exemplify fixtures 202 having one or more
contoured surfaces 281 and shapes more closely resembling at least
one surface of the human body, more specifically, the pelvic
region, and even more specifically, between the upper legs (or
thighs), the vaginal, urethral, and/or buttocks regions.
[0033] The bore 208 may be configured to have a size that
corresponds to a predetermined pressure that is applied to the
sample 204 by the fixture 202. For example, bore 208 is configured
to have a diameter 207 that is slightly smaller than the sample 204
of a device such as a tampon, such that a predetermined bodily
pressure is exerted along at least a portion of the sample 204 (and
in some embodiments, along the entire axial length of the sample
204). For example, the fixture 202 applies at least one of a
hydraulic pressure or a pneumatic pressure to the sample 204. To
apply such pressure, a wrapper 212 is provided proximal, adjacent
to and/or surrounding the sample 204. The wrapper 212 is made of a
material having a low density that is sufficiently distinct from
the fluid 246 density and/or sample 204 density, to avoid any
imaging confusion with sample 204. The wrapper 212 is often
positioned in close proximity to sample 204, so it is critical the
wrapper 212 is radiographically discernable from the sample 204
and/or the fluid 246 contained within the wrapper 212. Such wrapper
212 materials include hydrophobic foams, closed cell foams,
polyurethane, plastics, films and laminates, polyethylene, low
density polyethylene, linear low density polyethylene, polyester,
polypropylene, nylon and other long-chain carbon materials, etc.
The system utilizes fluid of a predetermined viscosity. In some
embodiments, the fluid has varying viscosity. In some embodiments,
the fluid utilized to generate hydraulic or pneumatic pressure is
non-Newtonian. The application of the pressure to the sample 204
may be done to simulate an application of bodily pressure to the
sample 204 when the sample 204 (or an analogous sample) is inserted
in a body cavity.
[0034] The pressure is preferably between about 0.1 psi to about 5
psi, and more preferably between about 0.25 psi and 1 psi. Such
pressure can be exerted by the fixture 202 in its entirety to
simulate an overall bodily pressure. Alternatively [or additively],
such pressure can be exerted by a single aspect or member of the
fixture 202 to simulate certain anatomical features that exude
pressure against a sample 204. Further, other pressures exerted by,
for instance, involuntary or voluntary bodily reactions such as
hiccups, sneezing, coughing, laughing, etc., can also create
dynamic pressure(s). For example, the fixture 202 may provide a
pressure of about 0.25 psi to simulate pressure of the body
surrounding the vaginal canal, but may have an additional member
209 that adds an additional pressure simulating the pressure
applied to the vaginal cavity by a full or partially full bladder.
The additional member 209 in the fixture 202 can be located within
and/or proximal the bore 208 such that it applies pressure directly
to the sample 204 and/or indirectly to the sample 204. Additional
member 209 can comprise a bladder and contain fluid, and can be
dynamic (i.e. fluid volume in the bladder increases or decreases).
The pressure exerted by the additional member 209 can be dynamic
alone or in concert with the fixture 202 (i.e. where the fixture
202 applies dynamic pressure). Dynamic pressure can be described as
pressure that changes over time. Dynamic pressure also includes, in
certain embodiments, the force exerted outwardly by a consumer
product as it absorbs and/or retains fluid (and thus expands or
changes in size/shape).
[0035] Additional member 209 provides fixture 202 the opportunity
to have a plurality of different pressures exerted by multiple
different objects and/or fluids. For instance, a first pressure
209a is exerted on the sample 204 by fixture 202. A second pressure
209b is provided via fluid disposed or dispensed into a wrapper 212
surrounding and/or proximal to the sample 204 situated in or
adjacent to the fixture 202 (i.e. in the bore 208 as shown in FIG.
3). A third pressure is provided via additional member 209 situated
proximal the fixture 202 such that it exerts an additional force or
pressure onto the fixture 202, causing the simulation of another
environmental variable. In this embodiment, the fixture 202
simulates general bodily pressure. The additional member 209
simulates the environment of the vaginal canal. The additional
member 209 simulates the pressure exerted within the body against
the vaginal canal by the bladder.
[0036] In one embodiment, the fixture 202 permits expansion to
accommodate studies of dynamic systems. The fixture 202 permits
expansion to, for instance, permit a significant amount of pressure
to be exerted (via the accumulation of fluid 246 in the bladder of
additional member 209) while keeping the bladder within the fixture
202 and proximal the sample 204. The fixture 202 can comprise a
material that is expandable or extensible or compressible such that
it changes shape in response to the, for instance, bladder's shape.
In embodiments where the fixture 202 material is compressible, it
must remain radiotransparent upon compression. Advantageously,
compressible structures can be structured to maintain the general
shape and size of the footprint to ensure the system 200 isn't
altered.
[0037] In embodiments where the fixture 202 is expandable or
extensible, it can be due to the material properties of the fixture
202 itself, and/or the physical structure. For instance, and as
exemplified in FIGS. 1 and 2, the fixture 202 can have arms 238
that deviate in position upon expansion of the sample 204 and/or
due to the expansion of additional member(s) 209.
[0038] In further embodiments, the fixture 202 has one or more
retaining straps 214. In a first embodiment, the one or more
retaining straps 214 are extensible thereby permitting
expansion/deflection after a certain level of force is reached
(i.e. a force exceeding the force exerted by the retaining strap(s)
214). This can be advantageous in set-ups where deflection is
useful for inserting samples 204 into (or adjacent to, or onto the
fixture 202) and/or modifying the fixture 202 to perform in a
certain manner, while ensuring the fixture 202 remains
substantially static with respect to the platform 216 during the
test.
[0039] In some embodiments, the one or more retaining straps 214
can be positioned to provide pressure to the fixture 202 to
simulate bodily pressures in addition to, in lieu of, or to support
pressures exerted by other portions or structures of the fixture
202. The one or more retaining strap 214 can be placed around a
portion of the fixture 202 to exert a specific pressure around a
portion of the length, width and/or height of the sample 204. The
one more retaining strap 214 can be placed around a portion of the
fixture 202 to exert a specific pressure adjacent a sample 204,
such as proximal to the inferior sample 204 end and/or the superior
sample 204 end, the sample forward end, the sample rearward end,
etc. . . . . In these embodiments, a pressure adjacent the sample
204 can simulate the sample's 204 performance in vivo, modeling the
pressure applied by external anatomy such as limbs (i.e. arms or
legs), by internal anatomy such as the cervical os, the bladder,
the vaginal wall, the introitus, and/or by garments such as
underwear, pants, etc. . . . .
[0040] In a second embodiment, the one or more retaining strap 214
are substantially rigid. In this embodiment, the fixture 202
remains substantially static during the test, but permits access or
modification to the fixture 202 before and after the test.
[0041] The one or more retaining straps 214 can be a unitary
structure such as an elastomeric band or tape. The one or more
retaining straps 214 can also have a clasp 213 permitting
adjustment of the one or more retaining straps 214 to modify
pressure around at least a portion of fixture 204. The one or more
retaining straps 214 can be attached and/or positioned on or
surrounding a portion of fixture 204, or can be attached to
platform 216, or combinations thereof.
[0042] The fixture 202 may include a fluid source 210 that is
configured to introduce/apply a fluid 246 to the sample 204 by a
line 211 coupling the fluid source 210 and the sample 204 in FIG.
7. Fluid source 210 is attachable to system 200, to fixture 202,
and/or to platform 216. The fluid 246 provided by the fluid source
210 may be of any type or composition, such as water, menses,
blood, synthetic menses, glycerin, etc., or a mixture of one or
more of the aforementioned fluids. In some embodiments, a dye may
be used in the fluid 246. The fluid 246 may be selected to have a
density that is sufficiently distinct from the density of the
fixture 202 (in an amount greater than a threshold), such that the
fluid 246 and the fixture 202 can be distinguished from one another
via imaging technology. In some embodiments, the fluid 246 density
is significantly distinct from a density of the fixture 202. In
some embodiments, the fixture 202 may be
clear/see-through/translucent to a user's naked eye (to facilitate
a visual inspection of the sample 204 when the sample is retained
in the fixture 202), such that the fixture 202 may be optically
transparent. However, in some embodiments the fixture 202 might
only be radiographically transparent/translucent.
[0043] Starting with a dry sample 204, the fixture 202 may cause
the fluid source 210 to apply fluid 246 to the sample 204 until the
sample 204 is saturated.
[0044] The fixture 202 may include a wrapper 212. The wrapper 212
may retain the sample 204 in the bore 208 of the retaining
mechanism 206. The wrapper 212 encompasses at least a majority of
an outer periphery of said fixture 202. To the extent fluid 246
escapes the sample 204 and/or is meant to surround sample 204, the
wrapper 212 may prevent fluid 246 from the fluid source 210 leaking
onto/into the retaining mechanism 206/bore 208 by creating a
barrier between the bore 208, the opening 231 and/or the fixture
202 in general that substantially keeps fluid inside the wrapper
212.
[0045] FIGS. 5-7 provide an additional aspect of the present
disclosure, where the fixture 202 and/or retaining mechanism 206
are configured to more specifically replicate an in vivo set-up. As
shown in FIGS. 5-6, Fixture 202 includes a first region 280, a
second region 282, and a third region 284. The first region 280,
second region 282 and third region 284 can be fixed and stationary
(with respect to each other) or movable and dynamic (with respect
to each other) The first region 280 and the third region 284
support second region 282, and/or simulate a portion of the human
body. First region 280 and second region 284 provide support for
second region 282, and as such, resemble limbs such as legs in an
in vivo setup. Second region 282 provides at contoured surface 281.
Second region 282 has a contoured surface 281 emulating at least
one surface of an in vivo setup. First region 280 and/or third
region 284 may also have contoured surfaces to further simulate an
in vivo setup.
[0046] FIG. 6 provides a retaining mechanism 206 holding sample 204
adjacent the body. Retaining mechanism 206 optionally includes one
or more retaining straps 214 (and optionally one or more clasps
213). Barrier 250 is adjacent retaining mechanism 206 on a surface
facing fixture 202 which is adjacent sample 204. Barrier 250 is
integral with retaining mechanism 206 and/or attachable to
retaining mechanism 206. Barrier 250 optionally has varying surface
topography to simulate vaginal rugae and/or other anatomical
features of the body.
[0047] FIG. 6 provides a bore 208 that is internal to fixture 202.
In this embodiment, bore 208 provides a means for retaining and/or
directing line 208 (and line end 211a) into a location that
simulates the urethra or vaginal cavity. In such embodiments, line
208 and line end 211a is positioned with respect to sample 204 to
simulate fluid flow in an in vivo setup. In further embodiments,
bore 208 extends through fixture 208 such that line 208 runs
internally through fixture 202; bore 208 has a first opening (not
shown) where line 208 enters and a second opening 208b where line
end 211a deposits fluid 246 onto or proximal to sample 204. In
further embodiments, bore 208 simulates an internal body cavity
such as the vaginal cavity. In other embodiments, line 208 is
positioned external to fixture 202 and attachable at least at a
position similar to where the urethra or vaginal opening would be
in an in vivo setup such that fluid 246 exits line end 211a at an
appropriate location proximal to or on sample 204.
[0048] FIGS. 8a-8c provide various views of a fixture 202 emulating
the midsection of a person. The description provided for FIGS. 5-7
also holds true with these embodiments exemplified by FIGS. 8a-8c.
Fixture 202 has a first region 280, second region 282, and a third
region 284. Fixture 202 replicates human body. Fixture 202 is, for
example cut from a radiotransparent material such as foam by a CNC
machine that has inputted data from a human body scan. The CNC
machine cuts individual slices of the radiotransparent material
which are thereafter connected by adhesive, one or more retaining
straps, etc. . . . . The CNC machine can optionally create bore 208
such that it also resembles the human body (i.e. the vaginal
cavity). In this manner, fixture 202 can simulate both internal and
external human anatomy and thus fixture 202 provides the
opportunity to have an in vitro setup that even more closely
resembles an in vivo one.
[0049] Referring now to FIG. 10, an illustrative system 100 is
shown. The system 100 may be associated with one or more computers.
The system 100 includes one or more processors (generally shown by
a processor 102) and a memory 104. The memory 104 may store data
106 and/or instructions 108. The system 100 may include a
computer-readable medium (CRM) 110 that may store some or all of
the instructions 108. The CRM 110 may include a transitory and/or
non-transitory computer-readable medium.
[0050] The instructions 108, when executed by the processor 102,
may cause the system 100 (or one or more portions thereof) to
perform one or more methodological acts or processes, such as those
described herein. As an example, execution of the instructions 108
may cause: one or more images of a sample to be captured based on
an introduction/application of a fluid 246 to the sample 204, a
data set to be obtained/generated based on the one or more images,
and an analysis to be performed based on the data set to determine
a grayscale value that represents a fluid 246 flow.
[0051] The data 106 may include the images, the data set or
additional data based on an analysis of the data. In some
embodiments, the data 106 may be associated with one or more
programs, such as a modeling or simulation program. For example,
the data may be native to or supported by one or more computed
aided design or computer aided drawing programs, either one or both
of which may be referred to as CAD programs.
[0052] The system 100 may include one or more input/output (I/O)
devices 112 that may be used to provide an interface between the
system 100 and one or more additional systems or components. The
I/O devices 112 may include one or more of a graphical user
interface (GUI), a display screen, a touchscreen, a keyboard, a
mouse, a joystick, a pushbutton, a microphone, a speaker, a
microphone, a transceiver, a sensor, etc.
[0053] The system 200 includes an imaging device 222. The imaging
device 222 may take/acquire one or more images of the sample 204,
such as when fluid 246 from the fluid source 210 is applied to the
sample 204. The frequency with which the one or more images are
taken can be dependent on the viscosity of the fluid 246 and/or the
properties of the sample 204. In other words, a fluid 246 having a
higher viscosity may travel more slowly through the sample 204, and
as such, time between images may be longer without missing
meaningful data sets. Alternatively, a sample 204 having greater
porosity, permeability, wicking rates, etc. . . . may require more
frequent imaging to fully capture data sets that will demonstrate
fluid 246 movement within sample 204. In some embodiments, sample
204 has multiple different materials and/or rates and the
configuration of such materials in sample 204 require varying rates
with which images are taken. For instance, images may need to be
taken more quickly as fluid 246 is introduced into a wicking layer
or highly permeable area of the sample 204, and thereafter, slower
time intervals for taking images may be sufficient as the fluid 246
travels more slowly through less permeable absorbent areas of the
sample 204. The skilled artisan understands that time intervals may
vary more complexly than described herein. In some embodiments,
images are taken less than one minute apart. In further
embodiments, images are taken about ten to fifteen seconds apart.
In further embodiments, images are taken less than ten seconds
apart.
[0054] In some embodiments, the fixture 202 or a portion thereof
(e.g., the retaining mechanism 206) may rotate in order to cause
the sample 204 to rotate. The rotation may occur at a predetermined
rate. The rotation may occur when the images are acquired by the
imaging device 222. Alternatively, or additionally, the imaging
device 222 may rotate relative to the fixture 202/sample 204.
Relative rotation enables capturing multiple views of the sample
204 during the test. In some embodiments, the fixture 202 is placed
upon and/or attached to the platform 216. The platform 216 is a
rotatable surface 216a (i.e. a turntable) in at least one plane
(i.e., the x-y plane, the y-z plane, and/or the x-z plane) and/or
optionally in at least two planes (i.e. a shaker table). In other
embodiments, the fixture 202 is attached to a gimbal 216b, 216c (as
represented by both solid and dashed lines in FIG. 9) permitting
dynamic movement in multiple planes or about multiple axes. The
platform 216 (i.e., rotatable surface 216a or gimbal 216b, 216c)
assists the imaging device 222 in visually capturing the sample
204's performance during the test.
[0055] As shown in FIG. 9, gimbal 216b, 216c has a first linkage
260, a second linkage 262 and a third linkage 264, where the first
linkage 260 and second linkage 262 are connected and/or movable
about each other at joint 270. Second linkage 262 and third linkage
264 are connected and/or movable about joint 272. Gimbal 216b, 216c
is stabilized by base 266. Gimbal 216b, 216c is connected directly
to base 266 or by shaft 268. The aforementioned configuration
permits rotation amongst first linkage 260 and second linkage 262,
and second linkage 262 and third linkage 264. In total, it permits
angular rotation of platform 216 and thusly fixture 202 and sample
204.
[0056] In some embodiments, a partial gimbal 216b is provided to
permit relative rotation between the sample 204 that is proximal to
the fixture 202 (i.e., within or adjacent the fixture 202) and the
imaging while not obstructing the imaging device 222 or any other
features connected to the fixture 202. A partial gimbal 216b is
exemplified by the solid lines in FIG. 9. For instance, the partial
gimbal provides three dimensional rotation in a partial sphere such
that other features can be positioned or connected to the test
fixture 202 in areas where there is no movement. Although rotation
is restricted with a partial gimbal, it still provides the ability
to study the sample 204 in simulated conditions (i.e. shifting of a
sample 204 during a person's gait, the sample's 204 response to one
or more dynamic bodily pressures, etc. . . . ). In some
embodiments, the partial gimbal is a half gimbal. In other
embodiments, a full gimbal is provided (as indicated by the solid
and dashed lines in FIG. 9).
[0057] In some embodiments, rotation about at least one axis
simulates relative in vivo movement of a person and the device. For
instance, and with respect to products worn on or internally to the
body during physical motion, a typical gait for a person is about
three miles per hour. As such, depending on the size of the fixture
202, the fixture 202 rotates about at least one axis at rate of
about 52 in/second. As people typically move at speeds between 0.1
mph and about 25 mph, the fixture 202 is capable of rotating at
speeds between about 1.7 in/second to about 806 in/second, or
perhaps more typical for most people partaking in exercise, speeds
between about 52 in/second to about 176 in/second.
[0058] As shown in FIG. 7, dynamic pressure can be applied via
additional members 209a and 209b. Additional members 209a, 209b
articulate about joint 248a, 248b, respectively. Additional members
are capable of applying a static pressure as well. Additional
members 209a, 209b apply pressure in at least one plane, or by
articulating about at least one axis. Such articulation can work in
concert with the movement of fixture 202 or retaining mechanism 206
on platform 216. For instance, additional members 209a and 209b can
simulate rubbing amongst body parts such as limbs and the torso, or
more specifically, the legs and the pelvic region, while a sample
is being worn externally as shown in FIG. 7 (or internally as
demonstrated throughout the specification). Movement of additional
members 209a, 209b can be done to simulate bodily pressures exerted
amongst body parts at a rate similar to that of a person walking,
running, or participating in athletics, as described in the present
disclosure. In certain embodiments, barrier 250 separates the
retaining mechanism 206 (or fixture 202, in other embodiments) and
sample 204 such that any fluid 246 escaping the sample 204 does not
saturate and/or soil retaining mechanism 206 (or fixture 202). This
simplifies cleaning and maintenance. As such, barrier 250 is an
impermeable material that is preferably radiotransparent, or at the
very least, has a density sufficiently distinct from the sample 204
and/or fluid 246. Some examples of materials include silicon and
other plastics and foams mentioned throughout the present
disclosure. Such a barrier 250 can be applied to any of the
exemplary fixtures of the present disclosure.
[0059] A modified syngyna test methodology can be used in
ascertaining fluid handling performance and absorbent
characteristics of the sample 204. Such a set-up includes a syringe
pump 220 moving fluid 246 from a fluid source 210 such as a beaker,
bag and/or graduated cylinder, to a line 211 located proximal to
the sample. The line 211 has a line end portion 211a that dispenses
(i.e. drips) fluid 246 at a predetermined rate controlled by the
syringe pump 220. The components of the line 211 and line end
portion 211a must be material that will not disrupt the imaging and
as such, should be made from a material that is sufficiently
distinct from sample 204 and/or fluid 246. Preferably, the line and
end portion are radio transparent. For instance, the rate is
between about 10 ml/hr to about 70 ml/hr, or more preferably,
between about 20 ml/hr to about 50 ml/r, or even more preferably,
about 25 ml/hr for internally worn menstrual products and about 50
ml/hr for externally worn hygiene products such as menstrual or
incontinence underwear, diapers, napkins, pads, and/or liners.
[0060] The imaging device 222 may be operative in accordance with
one or more imaging technologies. For example, the imaging device
222 may be operative in accordance with at least one of computed
tomography, magnetic resonance imaging, nuclear magnetic resonance
imaging, or magnetic resonance tomography. In some embodiments, the
imaging device 222 may include an imaging source 224 and an imaging
detector 226. The imaging source 224 and the imaging detector 226
may be operative in accordance with x-ray technology.
[0061] The system 200 includes a computer 232. The computer 232,
which may include one or more of the components/devices described
above in connection with the system 100 of FIG. 10, may be
configured to coordinate or synchronize the activities of the
fixture 202 and the imaging device 222. The computer 232 may also
perform one or more of the methodological acts described herein.
For example, the computer 232 may obtain one or more images from
the imaging device 222, obtain one or more data sets based on the
images, and perform an analysis in connection with data set(s) to
determine a grayscale value that represents a fluid flow through
the sample 204.
[0062] In some embodiments, one or more time stamps (e.g., a
scanning time) may be associated with the images acquired by the
imaging device 222. The time stamps may be used to generate a
four-dimensional data set associated with a fluid flow in the
sample 204. The four-dimensional data set may be obtained by
generating a three-dimensional data set based on the images
acquired by the imaging device 222 and applying the time stamps to
the three-dimensional data set.
[0063] In some embodiments, one or more radiographs may be acquired
by the imaging device 222. A radiograph may represent a
two-dimensional projection as interpreted by a detector of the
imaging device 222. A three-dimensional reconstruction may be
generated based on a synthesis of a plurality of radiographs. A
four-dimensional reconstruction may be generated based on an
application of the time stamps to the three-dimensional
reconstruction.
[0064] The systems 100 and 200 are illustrative. In some
embodiments, one or more of the components or devices may be
optional. In some embodiments, the components/devices may be
arranged in a manner that is different from what is shown in FIGS.
10 and 11. In some embodiments, additional components or devices
not shown may be included. For example, in embodiments where the
system 100 or the system 200 is included as part of one or more
networks, one or more switches, routers, and the like may be
included. One or more portions of the system 100 or the system 200
may be included in a particular computing device, such as a server,
a personal computer, a laptop, a mobile device (e.g., a
smartphone), etc.
[0065] As described above, the systems 100 and 200 may be used to
obtain a grayscale value representative of a fluid flow in the
sample 204. Referring to FIGS. 12A-3E (collectively referred to as
FIG. 12) a flow chart of a method 300 is illustrated for obtaining
such a grayscale value. The method 300 may be executed in
conjunction with the system 200, or a portion thereof.
[0066] In block 302, a data set may be obtained based on a
plurality of images acquired by, e.g., the imaging device 222 of
FIG. 11. The data set obtained in block 302 may by a
four-dimensional data set/reconstruction.
[0067] In block 306, an estimate is obtained regarding a grayscale
value that is representative of the fluid flow. The estimate may be
based on a user input to the system 200 of FIG. 11.
[0068] In block 310, a theoretical (volumetric) flow rate of the
fluid is obtained. The theoretical flow rate may be based on a user
input to the system 200 of FIG. 11.
[0069] In block 314, a "previous grayscale variable" may be
defined. As part of block 314, the previous grayscale variable may
be initialized/set to the estimate of the grayscale value obtained
in block 306.
[0070] In block 318, a "current grayscale variable" may be defined.
As part of block 318, the current grayscale variable may be
initialized/set to the estimate of the grayscale value obtained in
block 306.
[0071] In block 322, an "adjustment variable" may be defined. As
part of block 322, the adjustment variable may be initialized/set
equal to an "adjustment value". For reasons that will become more
apparent to a skilled artisan in view of the disclosure provided
below, the adjustment value may be selected based on a degree of
accuracy that is required and may be representative of a time it
takes for the method 300 to converge to a final grayscale value
representative of the fluid flow.
[0072] One skilled in the art will appreciate that the labels
applied to the variables in connection with the blocks 314-322 are
merely illustrative and the naming convention used is merely
intended to signify the nature or use of the variables. One skilled
in the art would appreciate that a more generic naming convention
could be used (e.g., first variable, second variable, etc.) without
departing from this disclosure.
[0073] In connection with block 326, a number of
sub-blocks/operations may be iteratively performed to arrive at, or
converge to, a final grayscale value representative of the fluid or
fluid flow. Block 326 is described in further detail below in
connection with FIGS. 12B-12E.
[0074] In block 326-a (see FIG. 12B), a volume may be calculated
for the data set of block 302 based on the current grayscale
variable. As part of block 326-a, a determination may be made
regarding a volume of what is intended to be the fluid as a
function of length (e.g., radial axis) for every data
set/reconstruction of block 302. This may be done by adding up the
volume of each voxel in each layer of the reconstruction whose
grayscale value is between the current grayscale variable and an
upper bound whose value is fixed relative to the current grayscale
variable. As an illustrative example, if the current grayscale
variable has a value of 1.34, and an upper bound offset is equal to
2.20, the upper bound may be equal to 1.34+2.20=3.54.
[0075] In block 326-b, a flow rate may be calculated based on the
volume calculated in block 326-a. As part of block 326-b, a linear
regression may be used to calculate the flow rate. The flow rate
may be based on a derivative of a curve formed with: (A) volume as
a dependent variable, and (B) imaging (e.g., scanning) time as an
independent variable.
[0076] In block 326-c, an error may be calculated as a difference
between the calculated flow rate of block 326-b and the theoretical
flow rate of block 310. The error calculation of block 326-c may be
conducted on an absolute value basis, such that the sign/polarity
in the error may be disregarded.
[0077] In block 326-d, a comparison may be made to determine
whether the error calculated in block 326-c is less than a
threshold. The threshold may be based on, or correspond to, the
error calculated in block 326-c during a previous iteration
associated with block 326. If the error is less than the threshold,
flow may proceed from block 326-d to block 326-e (see FIG. 12C).
Otherwise (e.g., the error is greater than or equal to the
threshold), flow may proceed from block 326-d to block 326-f(see
FIG. 12D).
[0078] In block 326-e (see FIG. 12C), the previous grayscale
variable may be set equal to the current grayscale variable.
[0079] In block 326-g, the current grayscale variable may be
modified based on the adjustment variable. For example, as part of
block 326-g the adjustment variable may be subtracted from the
current grayscale variable to generate an updated current grayscale
variable. Flow may proceed from block 326-g to block 326-a.
[0080] In block 326-f (see FIG. 12D), a comparison may be made to
determine whether the adjustment variable is less than a (second)
threshold. This threshold may be based on a resolution associated
with the system (e.g., system 200) that is used. The threshold may
be based on a user input. The threshold may serve as a factor in
the time it takes for the method 300 to converge to a final
grayscale value representative of the fluid flow; a smaller value
of the threshold (representative of a fine resolution) may result
in a longer convergence time relative to a larger value
(representative of a coarse resolution), all other things being
equal. The threshold may correspond to a predetermined value
associated with an accuracy resolution. If it is determined in
block 326-f that the adjustment variable is less than the
threshold, flow may proceed from block 326-f to block 326-h.
Otherwise (e.g., the adjustment variable is greater than or equal
to the threshold), flow may proceed from block 326-f to block 326-i
(see FIG. 12E).
[0081] In block 326-h, the iteration associated with block 326 may
end. Flow may proceed from block 326-h to block 330 (see FIG.
12A).
[0082] In block 326-i (see FIG. 12E), the previous grayscale
variable may be set equal to the current grayscale variable.
[0083] In block 326-j, the adjustment variable may be modified by
reducing the value of the adjustment variable. For example, the
adjustment variable may be reduced in half in block 326-j.
[0084] In block 326-k, the current grayscale variable may be
modified based on the adjustment variable. For example, as part of
block 326-k the adjustment variable may be added to the current
grayscale variable to generate an updated current grayscale
variable. Flow may proceed from block 326-k to block 326-a.
[0085] In block 330 (see FIG. 12A), the previous grayscale variable
may be provided as a representation of the fluid or fluid flow. The
method 300 may end following block 330.
[0086] While some of the parameters described above in conjunction
with the method 300 were described in terms of volume, the
parameters may be expressed in other terms (potentially in lieu of
expressing the parameters in terms of volume). For example, at
least some of the parameters may analogously be expressed in terms
of mass via one or more factors that may be used to convert between
volume and mass, as described further below.
[0087] In some embodiments, a calibration may be performed in
connection with the fixture 202. For example, and referring to FIG.
13, a fixture 402 (which may correspond to the fixture 202 of FIG.
11) may be configured to retain the sample 204 and a reference
sample 404 (in FIG. 13, details of the retaining mechanism 206, the
bore 208, and the wrapper 212 are omitted, with the understanding
that the same or analogous components may be applied to the sample
204 and/or the reference sample 404 in the fixture 402 of FIG. 13).
The reference sample 404 may be used to calibrate the grayscale
value due to the fluid in the reference sample 404 being the same
as that being introduced into the sample 204, as well as the mass
or volume of the fluid being predetermined/known.
[0088] If the reference sample 404 is placed/located out of plane
with respect to the sample 204, the likelihood of any other
materials with the same grayscale value appearing in-plane with the
reference sample 404 is sufficiently low in relation to any
potential impact on accuracy (aside from an insignificant amount of
noise that may be present). Therefore, if a correct grayscale value
is chosen, volume statistics calculated between the planes
containing the reference sample 404 may prove accurate.
[0089] Referring now to FIG. 14, a flow chart of a method 500 is
shown. The method 500 may be executed to obtain a grayscale value
representative of a fluid or fluid flow. The method 500 may be
similar to, or incorporate aspects of, the method 300 described
above. Aspects of the method 300 and the method 500 may be combined
with one another in some embodiments. The method 500 may be
executed in conjunction with the system 200 of FIG. 11, or a
portion thereof. The method 500 may be executed in conjunction with
the fixture 402 of FIG. 13.
[0090] In block 502, a data set/reconstruction (e.g., block 302),
an estimate of a grayscale value (e.g., block 306), a location of a
reference sample (e.g., the sample 404), and a specification of the
actual mass or volume of the reference sample may be obtained. The
location of the reference sample may be specified in terms of one
or more planes (e.g., two planes). As part of block 502, an
adjustment variable may be obtained/set, similar to block 322.
Similarly, a current grayscale variable may be obtained/set,
similar to block 318.
[0091] In block 506, masses or volumes may be calculated for the
data set of block 502 based on the current grayscale variable where
the reference sample is located. As part of block 506, a volume may
be converted to a mass by multiplying the volume by the fluid's
density. Block 506 may be analogous, or similar, to blocks 326-a
and 326-b. As part of block 506, one or more filtration or
averaging techniques (e.g., root-mean-square (RMS)) may be
applied.
[0092] In block 510, an error may be calculated as a difference
between the (average) mass/volume calculated in block 506 and the
actual reference sample mass/volume obtained in block 502. Block
510 may be analogous, or similar, to block 326-c.
[0093] In block 514, the error calculated in block 510 may be
compared to a threshold (e.g., the error calculated in block 510
during a previous iteration of the method 500, which may be stored
in a "previous error" variable). If the error of block 510 is less
than the threshold, flow may proceed from block 514 to block 518.
Otherwise, flow may proceed from block 514 to block 522. Block 514
may be analogous, or similar, to block 326-d.
[0094] In block 518, the current grayscale variable may be
stored/saved (into a previous grayscale variable) and then the
current grayscale variable may be modified using the adjustment
variable. Block 518 may be analogous, or similar, to blocks 326-e
and 326-g. Flow may proceed from block 518 to block 506.
[0095] In block 522, a determination may be made whether the
adjustment variable is less than a (second) threshold. Block 522
may be analogous, or similar, to block 326-f. If the adjustment
variable is less than the threshold, flow may proceed from block
522 to block 526 (and any iteration in connection with the blocks
506-526 and 530 may be ended in a manner similar to block 326-h).
Otherwise, flow may proceed from block 522 to block 530.
[0096] In block 530, the grayscale value may be stored/saved (into
the previous grayscale variable) and then the current grayscale
variable may be modified on the basis of a modified value for the
adjustment variable. Block 530 may be analogous, or similar, to
blocks 326-i, 326-j, and 326-k. Flow may proceed from block 530 to
block 506.
[0097] In block 526, the saved/stored (e.g., previous) grayscale
value (as reflected in the previous grayscale variable) may be
selected to represent the fluid or fluid flow. Block 526 may be
analogous, or similar, to block 330.
[0098] As described herein, the methodological acts and processes
may be tied to particular machines or apparatuses. For example, one
or more computers may include one or more processors and memory
storing instructions, that when executed, perform the
methodological acts and processes described herein. Furthermore,
the methodological acts and processes described herein may perform
a variety of functions including transforming an article (e.g., a
data set) into a different state or thing (e.g., a grayscale value
representative of a fluid flow in a sample). In some embodiments,
the transformation may take place in accordance with a predefined
algorithm or formula.
[0099] While some of the examples described herein related to
personal care products, one skilled in the art would appreciate
that aspects of the disclosure may be applied in connection with
other types of samples.
[0100] Technical effects and benefits of this disclosure include an
ability to accurately and quickly characterize a fluid flow applied
to a sample as the fluid enters and flows through the sample. This
characterization may be made available on a substantially real-time
basis, providing insight into the progression of the fluid through
the sample.
[0101] Aspects of the disclosure have been described in terms of
illustrative embodiments thereof. Numerous other embodiments,
modifications, and variations within the scope and spirit of the
appended claims will occur to persons of ordinary skill in the art
from a review of this disclosure. For example, one of ordinary
skill in the art will appreciate that the steps described in
conjunction with the illustrative figures may be performed in other
than the recited order, and that one or more steps illustrated may
be optional in accordance with aspects of the disclosure. One or
more features described in connection with a first embodiment may
be combined with one or more features of one or more additional
embodiments.
* * * * *