Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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MALE FLUID COLLECTION ASSEMBLIES AND SYSTEMS, METHODS OF
USING, AND METHODS OF MANUFACTURING THE SAME
CROSS-SECTION TO RELATED APPLICATIONS
[0001] This
application claims priority to U.S. Provisional Patent Application No.
63/047,374 filed on July 2, 2020 and U.S. Provisional Patent Application No.
63/067,542
filed on August 19, 2020, the disclosure of each of which is incorporated
herein, in its
entirety, by this reference.
BACKGROUND
[0002] In various
circumstances, a person or animal may have limited or impaired
mobility such that typical urination processes are challenging or impossible.
For
example, a person may experience or have a disability that impairs mobility. A
person
may have restricted travel conditions such as those experienced by pilots,
drivers, and
workers in hazardous areas. Additionally, sometimes urine collection is needed
for
monitoring purposes or clinical testing.
[0003]
Urinary catheters, such as a Foley catheter, can be used to address some
of
these circumstances, such as incontinence. Unfortunately, however, urinary
catheters can
be uncomfortable, painful, and can lead to complications, such as infections.
Additionally, bed pans, which are receptacles used for the toileting of
bedridden patients,
such as those in a health care facility, arc sometimes used. Bed pans,
however, can be
prone to discomfort, spills, and other hygiene issues.
[0004]
Males who suffer the most severe consequences of urinary incontinence,
such
as discomfort, rashes, and sores are typically elderly and often bedbound.
They also
require continuous assistance to maintain hygiene. Characteristics often found
in these
patients: they typically lay on their back, the size of the penis often
decreases with age,
skin rolls containing fat tissue cause the penis to recede, often pointing
upward while in a
laying position, patients have difficulty reaching the penis and manipulating
devices. A
urine capture device should be designed with reference to these
characteristics.
[0005]
Available solutions are typically for use while standing up (such as cups
and
funnels), with a urine discharge port opposite to the distal end of the penis.
Other designs
such as condom-style catheters are difficult for patients to manipulate, too
often they are
dimensionally incompatible; and they do not stay on reliably.
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[0006]
Thus, there is a need for a device capable of collecting urine from a
person or
animal, particularly a male, comfortably and with minimal contamination of the
user
and/or the surrounding area.
SUMMARY
[0007] Embodiments
disclosed herein are directed to male fluid collection assemblies,
systems including the same, methods of manufacturing the same, and methods of
using
the same.
In an embodiment, a fluid collection assembly is disclosed. The fluid
collection assembly includes a sheath. The sheath includes at least one fluid
impermeable
barrier including a first panel and a second panel. The at least one fluid
impermeable
barrier defines a chamber at least partially defined by the first panel and
the second panel.
The at least one fluid impermeable barrier defines an outlet at a distal end
of the sheath
and an opening at a proximal end of the sheath. The sheath also includes at
least one
porous material disposed in the chamber. The fluid collection assembly also
includes a
base permanently secured to or configured to be permanently secured to the
proximal end
of the sheath. The base is configured to be attached to skin surrounding a
penis. The
base defines an aperture that corresponds to the opening of the sheath.
[0008]
In an embodiment, a system is disclosed. The system includes a fluid
collection assembly. The fluid collection assembly includes a sheath. The
sheath
includes at least one fluid impermeable barrier including a first panel and a
second panel.
The at least one fluid impermeable barrier defines a chamber at least
partially defined by
the first panel and the second panel. The at least one fluid impermeable
barrier defines an
outlet at a distal end of the sheath and an opening at a proximal end of the
sheath. The
sheath also includes at least one porous material disposed in the chamber. The
fluid
collection assembly also includes a base permanently secured to or configured
to be
permanently secured to the proximal end of the sheath. The base is configured
to be
attached to skin surrounding a penis. The base defines an aperture that
corresponds to the
opening of the sheath. The system also includes a vacuum source configured to
apply a
suction force, a fluid storage container, and at least one conduit connected
to the outlet
and in fluid communication with the vacuum source and the fluid storage
container.
[0009] In an
embodiment, a method of manufacturing a fluid collection assembly is
disclosed. The method includes attaching a first panel and a second panel of a
fluid
impermeable barrier together along at least a portion of edges thereof to form
a sheath in
which the first and second panels at least partially defining a chamber
therebetween. The
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fluid impermeable barrier defines an opening and an outlet. The method also
includes
disposing at least one porous material in the chamber.
[0010] In an embodiment, a method of using a system to collect
bodily fluids from an
individual is disclosed. The method includes attaching a base to skin
surrounding a penis.
The base permanently secured or configured to be permanently secured to a
sheath. The
sheath includes at least one fluid impermeable barrier including a first panel
and a second
panel. The at least one fluid impermeable barrier defines a chamber at least
partially
defined by the first panel and the second panel. The at least one fluid
impermeable
barrier defines a fluid outlet at a proximal end of the sheath and an opening
at a distal end
of the sheath. The sheath also includes at least one porous material disposed
in the
chamber.
[0011] Features from any of the disclosed embodiments may be
used in combination
with one another, without limitation. In addition, other features and
advantages of the
present disclosure will become apparent to those of ordinary skill in the art
through
consideration of the following detailed description and the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The drawings illustrate several embodiments of the
present disclosure,
wherein identical reference numerals refer to identical or similar elements or
features in
different views or embodiments shown in the drawings.
[0013] FIGS. IA and 1B are top and bottom isometric views, respectively, of
a fluid
collection assembly, according to an embodiment.
[0014] FIGS. IC and ID are cross-sectional schematics of the
fluid collection
assembly taken along planes C-C and D-D, respectively, according to any
embodiment.
[0015] FIG. IE is a top plan view of the second panel of the
fluid collection
assembly, according to an embodiment.
[0016] FIG. IF is a cross-sectional schematic of a porous
material, according to an
embodiment.
[0017] FIG. 1G is a cross-sectional schematic of the base 104,
according to an
embodiment.
[0018] FIG. 2A is a cross-sectional schematic of a fluid collection
assembly,
according to an embodiment.
[0019] FIG. 2B is a top plan view of the second panel,
according to an embodiment.
[0020] FIG. 3 is a cross-sectional schematic of a fluid
collection assembly, according
to an embodiment.
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[0021]
FIG. 4A is a cross-sectional schematic of a fluid collection assembly,
according to an embodiment.
[0022]
FIG. 4B is a cross-sectional schematic of the base shown in FIG. 4A,
according to an embodiment.
[0023] FIG. 5 is a
cross-sectional view of a fluid collection assembly that includes a
first panel and a second panel integrally formed together, according to an
embodiment.
[0024]
FIGS. 6A and 6B are cross-sectional schematics illustrating how
substantially
similar fluid collection assemblies may be used with a buried and non-buried
penis,
according to an embodiment.
[0025] FIG. 7 is a
block diagram of a system for fluid collection, according to an
embodiment.
[0026]
FIG. 8 is a flow diagram of a method to collect fluid, according to an
embodiment.
[0027]
FIG. 9 is a flow diagram of a method to manufacture a fluid collection
assembly, according to an embodiment.
DETAILED DESCRIPTION
[0028]
Embodiments disclosed herein are directed to male fluid collection
assemblies,
systems including the same, methods of manufacturing the same, and methods of
using
the same. An example fluid collection assembly includes a sheath and a base.
The
sheath includes a fluid impermeable barrier formed from at least a first panel
and a
second panel connected together. The first panel and the second panel at least
partially
define a chamber therebetween. The fluid impermeable barrier also defines a
fluid outlet
at a distal end of the sheath and an opening at a proximal end of the sheath.
The sheath
also includes at least one porous material disposed in the chamber. The base
may be
permanently secured to the sheath or the base may be configured to be
permanently
secured to the sheath at some time period in the future. The base defines an
aperture that
is aligned with the opening when the base is permanently attached to the
sheath. The
base is configured to be secured to a region about a penis of an individual
with the
aperture positioned over the penis. As such, the chamber of the sheath may be
configured
to receive one or more bodily fluids (e.g., urine, semen, sweat, etc.) from
penis.
[0029]
An example method of using the fluid collection assembly includes securing
the base to the region about the penis of an individual. The base is
positioned on the
individual such that the penis extends through (e. g. , the penis is not
buried) or is adjacent
to (e.g., the penis is buried) the aperture defined by the base. If sheath is
not already
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attached to the bast, the sheath may also be permanently attached to the base.
For
example, the sheath may be permanently attached to the base before, during, or
after
securing the base to the region about the penis. After the base is secured to
the region
about the penis and the sheath is attached to the base, the individual may
discharge bodily
fluids from the penis. The bodily fluids enter the chamber of the sheath. The
porous
material may receive at least some of the bodily fluids that enter the chamber
and direct
the bodily fluids towards the outlet. The method may include removing the
bodily fluids
from the chamber through the outlet, for instance, when a suction force is
applied to the
outlet via a vacuum source that is in fluid communication with the chamber.
[0030] FIGS. 1A and
1B are isometric top and bottom views, respectively, of a fluid
collection assembly 100, according to an embodiment. FIGS. 1C and 1D are cross-
sectional schematics of the fluid collection assembly 100 taken along planes C-
C and D-
D, respectively, according to any embodiment. The fluid collection assembly
100
includes a sheath 102 and a base 104. The sheath 102 includes a fluid
impermeable
barrier 106 that is at least partially formed from a first panel 108 attached
to a second
panel 110. In an embodiment, as illustrated, the first panel 108 and the
second panel 110
are distinct sheets. The fluid impermeable barrier 106 also defines a chamber
112
between the first panel 108 and the second panel, an opening 114 at a proximal
end
region 116 of the sheath 102, and an outlet 118 at a distal end region 120 of
the sheath
102. The sheath 102 also includes at least one porous material 122 disposed in
the
chamber 112. The base 104 includes an aperture 124. The base 104 is
permanently
attached to the proximal end region 116 of the sheath 102 such that the
aperture 124 is
aligned with the opening 114. Permanently attached means that the sheath 102
cannot be
detached from the base 104 without damaging at least one of the sheath 102 or
the base
104, using a blade to separate the sheath 102 from the base 104, using
chemicals to
dissolve the adhesive that attaches the sheath 102 to the base 104, and/or
using heat to
melt or soften the adhesive or attachment (e.g., ultrasonic weld) that
attached the sheath
102 to the base 104.
[0031]
The inner surfaces 126 of the fluid impermeable barrier 106 (e.g., inner
surfaces of the first and second panels 108, 110) at least partially defines
the chamber 112
within the fluid collection assembly 100. The fluid impermeable barrier 106
temporarily
stores the bodily fluids in the chamber 112. The fluid impermeable barrier 106
may be
formed of any suitable fluid impermeable material(s), such as a fluid
impermeable
polymer (e.g., silicone, polypropylene, polyethylene, polyethylene
terephthalate, a
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polycarbonate, etc.), a metal film, natural rubber, another suitable material,
or
combinations thereof. As such, the fluid impermeable barrier 106 substantially
prevents
the bodily fluids from passing through the fluid impermeable barrier 106. In
an example,
the fluid impermeable barrier 106 may be air permeable and fluid impermeable
thus
preventing leaks while allowing air flow through the chamber 112 when a
suction force is
applied thereto (i.e., the chamber 112 remains at about atmospheric pressure
thereby
preventing the suction force from causing a hickie or kinking the conduit
136). In such
an example, the fluid impermeable barrier 106 may be formed of a hydrophobic
material
that defines a plurality of pores. Alternatively or additionally, the fluid
impermeable
barrier 106 may include at least one perforation 128 (e.g., vacuum relief
hole) that allows
the chamber 112 to remain substantially at atmospheric pressure. At least one
or more
portions of at least an outer surface 130 of the fluid impermeable barrier 106
may be
formed from a soft and/or smooth material, thereby reducing chaffing.
[0032]
In an embodiment, at least one of the first panel 108 or the second panel
110 is
formed from an at least partially transparent fluid impermeable material, such
as
polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. Forming at
least one
of the first panel 108 or the second panel 110 from an at least partially
transparent fluid
impermeable material allows a person (e.g., medical practitioner) to examiner
the penis.
In some embodiments, both the first panel 108 and the second panel 110 are
formed from
at least partially transparent fluid impermeable material. For example,
some
conventional fluid collection assemblies that include a sheath and a base may
allow the
sheath to be reversibly detached from the base after the base is secured to
the region about
the penis. Detaching the sheath from the base allows the person to examine the
penis.
However, configuring the sheath to be detachable from the base may allow leaks
between
the sheath and the base. As previously discussed, the sheath 102 is
permanently attached
to the base 104 which substantially prevents leaks between the sheath 102 and
the base
104 when the base 104 is appropriately attached to the sheath 102 (e.g., no
wrinkles were
allowed to form between the sheath 102 and base 104). Selecting at least one
of the first
panel 108 or the second panel 110 to be formed from an at least partially
transparent
impermeable material allows the penis to be examined without detaching the
entire fluid
collection assembly 100 from the region about the penis. For example, the
chamber 112
may include a penis receiving area 132 that is configured to receive the penis
of the
individual when the penis extends into the chamber 112. The penis receiving
area 132
may be defined by at least the porous material 122 and at least a portion of
the at least
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partially transparent material of the first panel 108 and/or the second panel
110. In other
words, the porous material 122 is positioned in the chamber 112 such that the
porous
material is not positioned between the penis and at least a portion of the
transparent
portion of the first panel 108 and/or second panel 110 when the penis is
inserted into the
chamber 112 through the opening 114 (e.g., the penis is positioned between at
least a
portion of the second panel and the at least one porous material). The porous
material
122 is generally not transparent and, thus, the portion of the at least
partially transparent
material of the first panel 108 and/or the second panel 110 that defines the
penis receiving
area 132 forms a window which allows the person to view into the penis
receiving area
132 and examine the penis.
[0033]
In an embodiment, the second panel 110 is at least partially formed from
the at
least partially transparent material and forms the window that allows the
person to view
into the penis receiving area 132. Further, the porous material 122 is
positioned between
the penis receiving area 132 and at least a portion of the first panel 108.
Such an
embodiment may help maintain the dignity of the individual using the fluid
collection
assembly 100. For example. during use, the second panel 110 is generally
adjacent to the
individual, such as adjacent to the thighs and/or perineum. Thus, the second
panel 110 is
generally obscured during use and a person cannot view the penis without first
lifting the
sheath 102 away from the individual. Meanwhile, the first panel 108 may face
away from
the individual and be more easily viewable than the second panel 110. However,
a person
(e.g., a passerby, a visitor, etc.) cannot view the penis through the first
panel 108 because
the porous material 122 is not transparent and/or the first panel 108 is
formed from a non-
transparent material. Thus, in such an embodiment, the first panel 108 and/or
the porous
material 122 prevent person(s) from viewing the penis unless such examination
is
necessary, thereby preserving the dignity of the individual using the fluid
collection
assembly 100. In an embodiment, the first panel 108 is formed from the at
least partially
transparent material and forms the window that allows the person to view into
the penis
receiving area 132. Further, the porous material 122 is positioned between the
penis
receiving area 132 and at least a portion of the second panel 110. In such an
embodiment,
the person does not need to perform the additional act of lifting the sheath
102 to view
into the penis receiving area 132 but may not maintain the dignity of the
individual using
the fluid collection assembly 100 since passersby may also view into the penis
receiving
area 132.
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[0034]
As previously discussed, at least a portion of the first panel 108 and at
least a
portion of the second panel 110 are attached together. In an embodiment, as
shown, the
first and second panels 108, 110 are attached together along at least a
portion of the outer
edges 134 thereof. In such an embodiment, the first and second panels 108, 110
are
attached using any suitable technique, such as with an adhesive, sewing, heat
sealing,
radio frequency ("RF") welding, ultrasonic ("US") welding, or any other
technique. As
will be discussed in more detail below, forming the fluid impermeable barrier
106 from
the first panel 108 and the second panel 110 may improve the rate of
manufacturing the
fluid collection assembly 100, especially when the first panel 108 and the
second panel
110 are attached together using a non-sewing technique (e.g., the first and
second panels
108, 110 are free from a sewn joint formed by sewing the first and second
panels 108,
110 together).
[0035]
The opening 114 defined by the fluid impermeable barrier 106 provides an
ingress route for fluids to enter the chamber 112 when the penis is a buried
penis and
allow the penis to enter the chamber 112 (e.g., the penis receiving area 132)
when the
penis is not buried. The opening 114 may be defined by the fluid impermeable
barrier 106
(e.g., an inner edge of the fluid impermeable barrier 106). For example, the
opening 114
is formed in and extends through the fluid impermeable barrier 106, from the
outer
surface 130 to the inner surface 126, thereby enabling bodily fluids to enter
the chamber
112 from outside of the fluid collection assembly 100.
[0036]
FIG. lE is a top plan view of the second panel 110 of the fluid collection
assembly 100, according to an embodiment. In the illustrated embodiment, the
second
panel 110 defines the entirety of the opening 114. For example, the opening
114 is a
cutout defined by the second panel 110 that is spaced from the outer edges 134
of the
second panel 110. In such an example, the second panel 110 may exhibit a shape
that
substantially corresponds to the shape of the first panel 108 which may
facilitate attaching
the first panel 108 to the second panel 110 along the outer edges thereof. It
also allows
the first panel 108 and the second panel 110 to lie substantially flat when
the penis is not
in the chamber 112 which may make wearing the fluid collection assembly 100
more
discrete and inhibit pooling of bodily fluids against the individual. However,
in some
embodiments, the opening 114 is not spaced from the outer edges 134 of the
second panel
110. In such embodiments, the opening 114 may be a cutout extending inwardly
from at
least one outer edge 134 of the second panel 110. Also, as will be discussed
in more
detail with regards to FIGS. 2A and 2B, the opening 114 may not be formed as a
cutout.
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[0037]
Referring back to FIGS. 1A-1D, the fluid impermeable barrier 106 defines
an
outlet 118 sized to receive a conduit 136. The conduit 136 may be at least
partially
disposed in the chamber 112 or otherwise in fluid communication with the
chamber 112
through the outlet 118. The outlet 118 may be sized and shaped to form an at
least
substantially fluid tight seal against the conduit 136 thereby substantially
preventing the
bodily fluids from escaping the chamber 112. In an embodiment, the outlet 118
may be
formed from a portion of the first panel 108 and the second panel 110 that are
not
attached together. In such an embodiment, the fluid impermeable barrier 106
may not
include a cap exhibiting a rigidity that is greater than the portions of the
fluid
impermeable barrier 106 thereabout which may facilitate manufacturing of the
fluid
collection assembly 100 may decreasing the number of parts that are used to
form the
fluid collection assembly 100 and may decrease the time required to
manufacture the
fluid collection assembly 100. The lack of the cap may make securing the
conduit 136 to
the outlet 118 using interference fit difficult though, it is noted, attaching
the conduit 136
to the outlet 118 using interference fit may still be possible. As such, the
conduit 136
may be attached to the outlet 118 (e.g., to the first and second panels 108,
110) using an
adhesive, a weld, or otherwise bonding the outlet 118 to the outlet 118.
Attaching the
conduit 136 to the outlet 118 may prevent leaks and may prevent the conduit
136 from
inadvertently becoming detached from the outlet 118. In an example, the
conduit 136
may be attached to the outlet 118 in the same manufacturing step that attaches
the first
and second panels 108, 110 together.
[0038]
As previously discussed, the sheath 102 includes at least one porous
material
122 disposed in the chamber 112. The porous material 122 may direct the bodily
fluids to
one Or more selected regions of the chamber 112, such as away from the penis
and
towards the outlet 118. As such, the porous material 122 may facilitate the
removal of the
bodily fluids from the chamber 112 and form a padding layer that prevents the
penis from
resting against a damp material which may cause degradation of the skin of the
penis
and/or make the fluid collection assembly 100 more uncomfortable to wear. The
porous
material 122 may also blunt a stream of urine from the penis.
[0039] In an
embodiment, the porous material 122 is a wicking material configured to
wick any bodily fluids away from the opening 114 thereby preventing the bodily
fluids
from escaping the chamber 112. Such "wicking" may not include absorption of
fluid into
the wicking material. Put another way, substantially no absorption of fluid
into the
material may take place after the material is exposed to the fluid and removed
from the
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fluid for a time. While no absorption is desired, the term "substantially no
absorption"
may allow for nominal amounts of absorption of fluid into the wicking material
(e.g.,
absorbency), such as less than about 30 wt% of the dry weight of the wicking
material,
less than 20 wt%, less than 15 wt%, less than 10 wt%. less than about 7 wt%,
less than
about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1
wt%, or less
than about 0.5 wt% of the dry weight of the wicking material. The wicking
material may
also wick the fluid generally towards an interior of the chamber 112, as
discussed in more
detail below. In an embodiment, the porous material 122 is configured to
adsorb or
absorb the bodily fluids. Similar, to the wicking material, such adsorbing or
absorbing
material may move bodily fluids away from the opening 114 thereby preventing
the
bodily fluids from escaping the chamber 112.
[0040]
The porous material 122 may be formed from any suitable porous material.
For example, the porous material 122 may be formed from nylon (e.g., spun
nylon fibers),
polyester, polyurethane, polyethylene, polypropylene, other porous polymers,
hydrophobic foam, an open cell foam, wool, silk, linen, cotton (e.g., cotton
gauze), felt,
other fabrics, a coated porous material (e.g., a water repellent coated porous
material),
any other suitable porous materials, or combinations thereof.
[0041]
FIG. 1F is a cross-sectional schematic of a porous material 122, according
to
an embodiment. The porous material 122 includes a first layer 138 and a second
layer
140. The first and second layers 138, 140 may be a woven material. The porous
material
122 also includes a plurality of fibers 142 forming a layer between the first
layer 138 and
the second layer 140. Each of the first layer 138, the second layer 140, and
the plurality
of fibers 142 define a plurality of pores, thereby allowing transport of the
bodily fluids
and air circulation through the porous material 122. The pores defined by the
plurality of
fibers 142 may be at least one of larger or more numerous, thereby decreasing
the
likelihood that dried bodily fluids clog the porous material 122. The presence
of the
plurality of fibers 142 also cause the porous material 122 feel soft against
the penis and
provides a cushioning effect to the penis. The plurality of fibers 142 may
also prevent the
suction force from collapsing the porous material.
[0042] In an
embodiment, the plurality of fibers may space the first layer 138 and the
second layer 140 by a distance d. The distance d may be selected based on the
number of
fibers that form the plurality of fibers 142 and the density at which the
plurality of fibers
142 are packed together. For example, the distance d may be selected to be
about 0.25
mm or more, about 0.5 mm or more, about 0.75 mm or more, about 1 mm or more,
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1.5 nun Of more, about 2 mm or more, about 3 nun or more, about 4 nun or more,
about 5
mm or more, about 6 mm or more, about 8 nun or more, about 10 mm or more,
about
12.5 mm or more, about 15 mm or more, or in ranges of about 0.25 mm to about
0.75
mm, about 0.5 mm to about 1 mm, about 0.75 mm to about 1.5 mm, about 1 mm to
about
2 mm, about 1.5 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to
about 5
mm, about 4 mm to about 6 mm, about 5 mm to about 8 mm, about 6 mm to about 10
mm, about 8 mm to about 12.5 mm, or about 10 mm to about 15 mm. The thickness
of
the distance d may be selected to adjust the absorbency of the porous material
122. For
example, increasing the thickness may increase the volume of the plurality of
fibers 142
and/or the porosity defined by the plurality of fibers 142 which increases the
amount of
bodily fluids that may be received by and at least partially stored in the
porous material
122.
[0043]
The first layer 138, the second layer 140, and the plurality of fibers 142
may
be formed from any suitable material, such as a hydrophobic material, a
hydrophilic
material, polyester, cotton, or any other porous material disclosed herein. In
an
embodiment, one or more of the first layer 138, the second layer 140, or the
plurality of
fibers 142 are formed from a hydrophobic material that inhibits the porous
material 122
from storing the bodily fluids therein which may facilitate removal of the
bodily fluids
from the chamber 112. In an embodiment, one or more of the first layer 138,
and second
layer 140, or the plurality of fibers 142 are formed from a hydrophilic
material which
allows the porous material 122 to temporarily store the bodily fluids therein
thereby
limiting the quantity of bodily fluids that pool around the skin of the
individual. In an
embodiment, two or more of the first layer 138, the second layer 140, or the
plurality of
fibers 142 are formed from different materials. In such an embodiment, the
first layer
138 may define the penis receiving area 132 or is otherwise closer to the
penis receiving
area 132 than the second layer 140. The first layer 138 may be formed from a
hydrophobic material while the plurality of fibers 142 are formed from a
hydrophilic
material. Such a configuration may cause the bodily fluids to be pulled
through the first
layer 138 and temporarily stored in the plurality of fibers 142. However, the
first layer
138 may remain substantially dry due to the hydrophobicity thereof which
allows the
porous material 122 to feel dry to the penis.
[0044]
In an embodiment, not shown, the porous material 122 may be formed from
two layers instead of the three layers illustrated in FIG. IF. For example,
the porous
material 122 may be formed from a fluid permeable membrane and a fluid
permeable
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support. The fluid permeable support may define or otherwise be closer to the
penis
receiving area 132 than the fluid permeable support. The fluid permeable
membrane may
be composed and/or structured to wick bodily fluids away from the penis
receiving area
132, thereby minimizing the quantity of bodily fluids that are present in the
penis
receiving area 132 or otherwise present against the skin of the individual. It
is also noted
that the fluid permeable membrane may also be configured to adsorb or absorb
the bodily
fluids to minimize the quantity of bodily fluids that are present in the penis
receiving area
132 or otherwise present against the skin of the individual. The fluid
permeable
membrane may be formed from any of the porous materials disclosed herein. For
example, the fluid permeable membrane may be formed from fabric, such as a
gauze
(e.g., silk, linen, or cotton gauze), another soft fabric, or another smooth
fabric. Forming
the fluid permeable membrane from gauze, soft fabric, and/or smooth fabric (or
any of the
other porous materials 122 disclosed herein that may contact the penis) may
reduce
chaffing caused by the fluid collection assembly 100.
[0045] The fluid
permeable support is configured to support the fluid permeable
membrane since the fluid permeable membrane may be formed from a relatively
foldable,
flimsy, or otherwise easily deformable material. For example, the fluid
permeable
support may be positioned such that the fluid permeable membrane is disposed
between
the fluid permeable support and the fluid impermeable barrier 106. As such,
the fluid
permeable support may support and maintain the position of the fluid permeable
membrane. The fluid permeable support may include any of the fluid permeable
membrane materials disclosed herein above. For example, the fluid permeable
membrane
material(s) may be utilized in a more dense or rigid form than in the fluid
permeable
membrane when used as the fluid permeable support. The fluid permeable support
may
be formed from any fluid permeable material that is less deformable than the
fluid
permeable membrane. For example, the fluid permeable support may include a
porous
polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene,
etc.) structure
or an open cell foam. In some examples, the fluid permeable support may be
formed
from a natural material, such as cotton, wool, silk, or combinations thereof.
In such
examples, the material may have a coating to prevent or limit absorption of
fluid into the
material, such as a water repellent coating. In some examples, the fluid
permeable
support may be formed from fabric, felt, gauze, or combinations thereof.
[0046]
In an embodiment, the porous material 122 may include a single layer
(e.g.,
one of the first layer 138, the second layer 140, the layer formed from the
plurality of
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fibers 142, the fluid permeable membrane, the fluid permeable support, or
another porous
layer). In an embodiment, the porous material 122 may be formed from four or
more
layers.
[0047]
In an embodiment, the porous material 122 may be a sheet (e.g., a multi-
layer
sheet). The porous material 112 is a sheet when the porous material 112 at
least one of is
generally planar when lying on a flat surface, does not define a cavity (e.g.,
is not
tubular), or exhibits a length and width that is greater than a thickness
thereof. Forming
the porous material 122 as a sheet may facilitate the manufacturing of the
fluid collection
assembly 100. For example, forming the porous material 122 as a sheet allows
the first
panel 108, the second panel 110, and the porous material 122 to each be
sheets. During
the manufacturing of the fluid collection assembly 100, the first panel 108,
the second
panel 110, and the porous material 122 may be stacked and then attached to
each other in
the same manufacturing step. For instance, the porous material 122 may exhibit
a shape
that is the same size or, more preferably, slightly smaller than the size of
the first panel
108 and the second panel 110. As such, attaching the first panel 108 and the
second panel
110 together along the outer edges 134 thereof may also attach the porous
material 122 to
the first panel 108 and the second panel 110. The porous material 122 may be
slightly
smaller than the first panel 108 and the second panel 110 such that the first
panel 108
and/or the second panel 110 extend around the porous material 122 such that
the porous
material 122 does not form a passageway through the fluid impermeable barrier
106
through which the bodily fluids may leak. Also, attaching the porous material
122 to the
first panel 108 and/or the second panel 110 may prevent the porous material
122 from
significantly moving in the chamber 112, such as preventing the porous
material 122 from
bunching together near the outlet 118. In an example, the porous material 122
may be
attached to the first panel 108 or the second panel 110 (e.g., via an
adhesive) before or
after attaching the first panel 108 to the second panel 110. In an example,
the porous
material 122 may merely be disposed in the chamber 112 without attaching the
porous
material 122 to at least one of the first panel 108 or the second panel 110.
In an
embodiment, as will be discussed in more detail below, the porous material 122
may
exhibit shapes other than a sheet, such as a hollow generally cylindrical
shape.
[0048]
Generally, the sheath 102 is substantially flat when the penis is not in
the penis
receiving area 132 and the sheath 102 is resting on a flat surface. The sheath
102 is
substantially flat because the fluid impermeable barrier 106 is formed from
the first panel
108 and the second panel 110 instead of a generally tubular fluid impermeable
barrier.
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Further, as previously discussed, the porous material 122 may be a sheet,
which also
causes the sheath 102 to be substantially flat. The sheath 102 may also be
substantially
flat because the fluid collection assembly 100 may not include relatively
rigid rings or
caps that exhibit a rigidity that is greater than the portions of the fluid
impermeable
barrier 106 thereabout since such rings and caps may inhibit the sheath 102
being
substantially flat. In other words, the sheath 102 may be free from the one or
more ring
and/or the cap. It is noted that the sheath 102 is described as being
substantially flat
because at least one of the porous material 122 may cause a slight bulge to
form in the
sheath 102 depending on the thickness of the porous material 122, the outlet
118 and/or
conduit 136 may cause a bulge thereabout, or the base 104 may pull on portions
of the
sheath 102 thereabout. It is also noted that the sheath 102 may also be
compliant and, as
such, the sheath 102 may not be substantially flat during use since, during
use, the sheath
102 may rest on a non-flat surface (e.g., may rest on the testicles, the
perineum, and/or
between the thighs) and the sheath 102 may conform to the surface of these
shapes.
[0049] The ability
of the sheath 102 to be substantially flat when the penis is not in
the penis receiving area 132 and the sheath 102 is resting on a flat surface
allows the fluid
collection assembly 100 to be used with a buried and a non-buried penis. For
example,
when the fluid collection assembly 100 is being used with a buried penis, the
penis does
not extend into the penis receiving area 132 which causes the sheath 102 to
lie relatively
flat across the aperature 124. When the sheath 102 lies relatively flat across
the aperture
124, the porous material 122 extends across the aperature and is in close
proximity to the
buried penis. As such, the porous material 122 prevents or inhibits pooling of
bodily
fluids discharged from the buried penis against the skin of the individual
since the porous
material 122 will receive and remove at least a significant portion of the
bodily fluids that
would otherwise pool against the skin of the individual. Thus, the skin of the
individual
remains dry thereby improving comfort of using the fluid collection assembly
100 and
preventing skin degradation. However, unlike other conventional fluid
collection
assemblies that are configured to be used with buried penises, the fluid
collection
assembly 100 may still be used with a non-buried penis since the non-buried
penis can
still be received into the penis receiving area 132, even when the penis is
fully erect.
Additionally, the ability of the sheath 102 to be substantially flat allows
the fluid
collection assembly 100 to be used more discretely than if the sheath 102 was
not
substantially flat thereby avoiding possibly embarrassing scenarios.
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[0050]
When the sheath 102 is substantially flat, the porous material 122
occupies
substantially all of the chamber 112 and the penis receiving area 132 is
collapsed (shown
as being non-collapsed in FIGS. 1C and 1D for illustrative purposes). In other
words, the
sheath 102 may not define an region that is constantly unoccupied by the
porous material
122. When the porous material 122 occupies substantially all of the chamber
112, the
bodily fluids discharged into the chamber 112 arc unlikely to pool for
significant periods
of time since pooling of the bodily fluids may cause sanitation issues, cause
an odor,
and/or may cause the skin of the individual to remain in contact with the
bodily fluids
which may cause discomfort and skin degradation.
[0051] As previously
discussed, the first panel 108, the second panel 110, and the
porous material 122 may be selected to be relatively flexible. The first panel
108, the
second panel 110, and the porous material 122 are relatively flexible when the
first panel
108, the second panel 110, and the porous material 122, respectively, are
unable to
maintain their shape when unsupported. The flexibility of the first panel 108,
the second
panel 110, and the porous material 122 may allow the sheath 102 to be
substantially flat,
as discussed above. The flexibility of the first panel 108, the second panel
110, and the
porous material 122 may also allow the sheath 102 to conform to the shape of
the penis
even when the size and shape of the penis changes (e.g., becomes erect) and to
minimize
any unoccupied spaces in the chamber 112 in which bodily fluids may pool.
[0052] As previously
discussed, the fluid collection assembly 100 includes a base 104
that is configured to be permanently attached to the sheath 102. The base is
configured to
be permanently attached to the sheath 102 when, for example, the fluid
collection
assembly 100 is provided with the base 104 permanently attached to the sheath
102 or the
base 104 is provided without being permanently attached to the sheath 102 but
is
configured to be permanently attached to the sheath 102 at some point in the
future. The
base 104 may be permanently attached to the sheath 102 using any suitable
technique.
For example, the base 104 may be permanently attached to the sheath 102 using
an
adhesive, sewing, heat sealing, RF welding, or US welding.
[0053]
As previously discussed, the base 104 is sized, shaped, and made of a
material
to be coupled to the skin that surrounds the penis (e.g., mons pubis, thighs,
testicles,
and/or perineum) and have the penis disposed therethrough. For example, the
base 104
may define an aperture 124 configured to have the penis positioned
therethrough. In an
example, the base 104 may exhibit the general shape or contours of the skin
surface that
the base 104 is configured to be coupled with. The base 104 may be flexible,
thereby
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allowing the base 104 to conform to any shape of the skin surface and mitigate
the base
104 pulling the on skin surface. The base 104 may extend laterally past the
sheath 102
thereby increasing the surface area of the skin of the individual to which the
fluid
collection assembly 100 may be attached compared to a substantially similar
fluid
collection assembly 100 that did not include a base.
[0054]
FIG. 1G is a cross-sectional schematic of the base 104, according to an
embodiment. The base 104 includes a substrate 146 having a top surface 148 and
a
bottom surface 150. The top surface 148 is closer to the sheath 102 than the
bottom
surface 150 while the bottom surface 150 is closer to the skin of the
individual than the
top surface 148. The base 104 may also include an adhesive layer 152 disposed
on at
least a portion of the bottom surface 150. The adhesive layer 152 is
configured to attach
the base 104 to the skin around the penis. The base 104 may also include a
release liner
153 is configured to be easily removed from the adhesive layer 152 and is
configured to
prevent the adhesive layer 152 inadvertently becoming attached to an object.
[0055] The substrate
146 may be formed from a fluid impermeable material to
prevent bodily fluids from leaking from the chamber 112 through the base 104.
For
example, the substrate 146 may be formed from any of the fluid impermeable
materials
disclosed herein.
[0056]
In an embodiment, the substrate 146 is formed from a thin film exhibiting
a
thickness that is about 2 nun or less, about 1.5 mm or less, about 1 nun or
less, about 0.75
mm or less, about 0.5 mm or less, about 0.3 mm or less, about 0.2 mm or less,
about 0.1
mm or less, about 0.05 min or less, or in ranges of about 0.05 mm to about 0.2
mm, about
0.1 mm to about 0.3 mm, about 0.2 mm to about 0.5 mm, about 0.3 mm to about
0.75
mm, about 0.5 mm to about 1 mm, about 0.75 mm to about 1.5 mm, or about 1 to
about 2
mm. Forming the substrate 146 as a thin film exhibiting any of the above
thicknesses
may cause the substrate 146 to be sufficiently flexible to conform to the
shape and
contours of the skin surrounding the penis. For instance, the shape and
contours of the
skin surrounding the penis may vary from individual to individual and
configuring the
substrate 146 to be a thin film may allow the base 104 to conform to the shape
and
contour of the skin surrounding the penis while preventing the formation of
any gaps
between the base 104 and the skin through which bodily fluids may leak.
Further, the
thin film substrate 146 is able to be attached to the skin of the individual
without or
substantially without pulling the skin of the individual which makes the fluid
collection
assembly 100 more comfortable to use for prolonged periods of time. It is
noted that the
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amount of the fluid collection assembly 100 pulls on the skin decreases with
decreasing
thickness of the substrate such that, for example, a substrate exhibiting a
thickness of
about 2 mm pulls more on the skin than a substantially similar substrate
exhibiting a
thickness of about 0.5 mm.
[0057] The adhesive
layer 152 may be formed from any adhesive that may safely
attach the substrate 146 to the skin surrounding the penis. In an example, the
adhesive
layer 152 may be formed from a silicone-based adhesive, such as a silicone-gel
adhesive.
Silicone-based adhesives, such as Silicone Medical Silicone Tape 2475P
available from
3M, has been found to secure the fluid collection assembly 100 to the skin
surrounding
the penis for at least 24 hours, even immediately after cleaning the skin
surface with a
wipe. In an example, the adhesive layer 152 may be formed from an acrylic gel
adhesive
or a hydrogel.
[0058]
In an embodiment, the base 104 is at least partially transparent (e.g.,
the
substrate 146 and the adhesive layer 152 are formed from at least partially
transparent
materials). In such an embodiment, a person (e.g., medical practitioner) may
be able to
examiner the skin surrounding the penis, such as to determine the health of
the skin.
Further, the person may be able to detect any gaps between the base 104 and
the skin of
the individual through which bodily fluids may leak. A person may be able to
eliminate
the gaps or replace the fluid collection assembly 100 after detecting the gaps
to prevent
leaks and prevent degradation of the skin caused by the skin being in contact
with the
bodily fluids.
[0059]
Referring back to FIGS. IA-ID, in an embodiment, the base 104 may exhibit
a generally partially triangular shape, as illustrated. For example, the base
104 may
exhibit three apexes 154 and edges 156 extending between each of the apexes
154. The
apexes 154 may be rounded to prevent the base 104 from digging into and
hurting the
individual. In an embodiment, the aperture 124 may be located off-center and
closer to
one of the apexes 154 than the other apexes 154. Such an embodiment may
maximize the
surface area of the skin to which the base 104 is attached, thereby reducing
the likelihood
that the base 104 leaks or inadvertently becomes detached from the individual.
For
example, the apex 154 closest the aperture 124 may be configured to be
attached to the
skin between the penis and the testicles and/or the testicles which has
limited surface area
to be attached to the base 104 and/or may be sensitive. Meanwhile, the portion
of the
base 104 opposite the apex 154 that is closest to the aperture 124 is
configured to be
attached to the mons pubis which has a large surface area and is less
sensitive. Other
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examples of shapes that the base 104 may form are disclosed in PCT Application
No.
PCT/US2021/015787 filed on January 29, 2021, the disclosure of which is
incorporated
herein, in its entirety, by this reference.
[0060]
As previously discussed, the fluid collection assembly 100 includes a
conduit 136. The conduit 136 may include a flexible material such as plastic
tubing (e.g.,
medical tubing). Such plastic tubing may include a thermoplastic elastomcr,
polyvinyl
chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing. In
some examples,
the conduit 136 may include silicon or latex. In some examples, the conduit
136 may
include one or more portions that are resilient, such as to by having one or
more of a
diameter or wall thickness that allows the conduit to be flexible.
[0061]
An inlet 144 of the conduit 136 may be located at or near the distal end
region
120 of the sheath 102 which is expected to be the gravimetrically low point of
the
chamber 112 when worn by a user. Locating the inlet 144 at or near the distal
end region
120 of the sheath 102 enables the conduit 136 to receive more of the bodily
fluids than if
the inlet 144 was located elsewhere and reduce the likelihood of pooling
(e.g., pooling of
the bodily fluids may cause microbe growth and foul odors). For instance, the
bodily
fluids in porous material 122 due to capillary forces. However, the bodily
fluids may
exhibit a preference to flow in the direction of gravity, especially when at
least a portion
of the porous material 122 is saturated with the bodily fluids. Accordingly,
the inlet 144
may be located in the fluid collection assembly 100 in a position expected to
be the
gravimetrically low point in the fluid collection assembly 100 when worn by a
user.
[0062]
In an example, the conduit 136 is configured to be at least insertable
into the
chamber 112, such as into the penis receiving area 132. In such an example,
the conduit
136 may include one or more markers (not shown) on an exterior thereof that
are located
to facilitate insertion of the conduit 136 into the chamber 112. For example,
the conduit
136 may include one or more markings thereon that are configured to prevent
over or
under insertion of the conduit 136. In another example, the conduit 136 may
include one
or more markings thereon that are configured to facilitate correct rotation of
the conduit
136 relative to the chamber 112. The one or more markings may include a line,
a dot, a
sticker, or any other suitable marking.
[0063]
As described in more detail below, the conduit 136 is configured to be
coupled
to, and at least partially extend between, one or more of the fluid storage
container (not
shown) and the vacuum source (not shown). In an example, the conduit 136 is
configured
to be directly connected to the vacuum source (not shown). In such an example,
the
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conduit 136 may extend from the fluid impermeable barrier 106 by at least one
foot, at
least two feet, at least three feet, or at least six feet. In another example,
the conduit 136
is configured to be indirectly connected to at least one of the fluid storage
container (not
shown) and the vacuum source (not shown). In some examples, the conduit is
secured to
a wearer's skin with a catheter securement device, such as a STATLOCK
catheter
securement device available from C. R. Bard, Inc., including but not limited
to those
disclosed in U.S. Patent Nos. 6,117,163; 6,123,398; and 8,211,063, the
disclosures of
which are all incorporated herein by reference in their entirety.
[0064]
The inlet 144 and an outlet of the conduit 136 are configured to fluidly
couple
(e.g., directly or indirectly) the vacuum source (not shown) to the chamber
112. As the
vacuum source (FIG. 7) applies a vacuum/suction in the conduit 136, the bodily
fluids in
the chamber 112 may be drawn into the inlet 144 and out of the fluid
collection assembly
100 via the conduit 136. In some examples, the conduit 136 may be frosted or
opaque
(e.g., black) to obscure visibility of the bodily fluids therein.
[0065] In some
examples, the vacuum source may be remotely located from the fluid
collection device. In such examples, the conduit 136 may be fluidly connected
to the
fluid storage container, which may be disposed between the vacuum source and
the fluid
collection assembly 100.
[0066]
During operation, a male using the fluid collection assembly 100 may
discharge bodily fluids (e.g., urine) into the chamber 112. The bodily fluids
may pool or
otherwise be collected in the chamber 112 (e.g., received into the porous
material 122).
At least some of the bodily fluids may be pulled through the interior of the
conduit 136
via the inlet 144. The bodily fluids may be drawn out of the fluid collection
assembly
100 via the vacuum/suction provided by the vacuum source. During operation,
the
perforation 128 may substantially maintain the pressure in the chamber 112 at
atmospheric pressure even though bodily fluids are introduced into and
subsequently
removed from the chamber 122.
[0067]
FIG. 2A is cross-sectional schematic of a fluid collection assembly 200,
according to an embodiment. Except as otherwise disclosed herein, the fluid
collection
assembly 200 is the same or similar to any of the other fluid collection
assemblies
disclosed herein, in one or more aspects. For example, the fluid collection
assembly 200
includes a sheath 202 and a base 204. The sheath 202 includes a fluid
impermeable
barrier 206 that includes a first panel 208 and a second panel 210. The fluid
impermeable
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barrier 206 may define a chamber 212 and an opening 214. The sheath 202 also
includes
at least one porous material 222 position in the chamber 212.
[0068]
FIG. 2B is a top plan view of the second panel 210, according to an
embodiment. As shown, the second panel 210 does not include a cutout similar
to the
second panel 110 shown in FIG. 1E, according to an embodiment. Instead, the
second
panel 210 exhibits a size and shape that is substantially similar to the first
panel 208.
When the second panel 210 does not include a cutout, both the first and second
panels
208, 210 define the opening 214 However, referring back to FIG. 2A, the second
panel
210 may form one or more wrinkle 258 when the fluid collection assembly 200
lies flat or
is in use. The wrinkle 258 may slightly press against the individual, which
may help
maintain the position of the sheath 202 against the individual. However,
manufacturing
of the fluid collection assembly 200 may be simplified when the first panel
208 and the
second panel 210 exhibit the same size and shape since only one type of panel
is required
to form the fluid collection assembly 200 instead of two.
[0069] As previously
discussed, the porous material of the fluid collection assemblies
disclosed herein may exhibit a non-sheet like shape. FIG. 3 is a cross-
sectional
schematic of a fluid collection assembly 300, according to an embodiment.
Except as
otherwise disclosed herein, the fluid collection assembly 300 is the same or
similar to any
of the other fluid collection assemblies disclosed herein, in one or more
aspects. For
example, the fluid collection assembly 300 includes a sheath 302 and a base
304. The
sheath 302 includes a fluid impermeable barrier 306 that includes a first
panel 308 and a
second panel 310. The fluid impermeable barrier 306 may define a chamber 312
and an
opening 314. The sheath 302 also includes at least one porous material 322
position in
the chamber 312.
[0070] The porous
material 322 exhibits a non-sheet like shape. Examples non-sheet
like shapes that the porous material 322 may exhibit includes a hollow
generally
cylindrical shape or at least two sheets that are attached together along at
least a portion
of the outer edges thereof. In an example, when the porous material 322
exhibits a non-
sheet like shape, the porous material 322 may at least partially defined the
penis receiving
area 332 such that the porous material 322 is positioned between the penis
receiving area
332 and at least a portion of the first panel 308 and between the penis
receiving area 332
and at least a portion of the second panel 310. In such an example, the porous
material
322 may prevent pooling of bodily fluids against portions of the first panel
308 or second
panel 310 that would otherwise define the penis receiving area 332. However,
the non-
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sheet like shape of the porous material 322 may cause the porous material 322
to be
spaced from the opening 314. Further, the non-sheet like shape of the porous
material
322 may prevent a person from viewing the penis in the penis receiving area
332, though
this may he mitigated by forming one or more cutouts (not shown) in the porous
material
322.
[0071]
As previously discussed, the fluid collection assemblies disclosed herein
may
be provided with the base not attached to the sheath. Instead, the base may be
configured
to be attached to the sheath at some time after providing the fluid collection
assembly.
FIG. 4A is a cross-sectional schematic of a fluid collection assembly 400,
according to an
embodiment. Except as otherwise disclosed herein, the fluid collection
assembly 400 is
the same or similar to any of the other fluid collection assemblies disclosed
herein, in one
or more aspects. For example, the fluid collection assembly 400 includes a
sheath 402
and a base 404. The sheath 402 includes a fluid impermeable barrier 406 that
includes a
first panel 408 and a second panel 410. The fluid impermeable barrier 406 may
define a
chamber 412 and an opening 414. The sheath 402 also includes at least one
porous
material 422 position in the chamber 412.
[0072]
The base 404 is not permanently attached to the sheath 402. Instead, the
base
404 may be permanently attached to the sheath 402 before, during, or after
attaching the
base 404 to the skin surrounding the penis. In an example, attaching the base
404 to the
sheath 402 after providing the fluid collection assembly 400 may allow for a
base to be
selected from a plurality of differently shaped and/or contoured bases. As
previously
discussed, the shape and contours of the skin surrounding the penis may vary
from
individual to individual. Selecting a base from the plurality of bases allows
a base to be
selected at least one of having the maximum possible size to limit leaks and
improve the
attachment between the base and the skin or exhibiting a contour that better
corresponds
to the contour of the skin to limit pulling. In an example. a person applying
the base 404
to the individual may find it easier to correctly position the base 404 on the
individual
when the sheath 402 is not attached to the base 404 since not attaching the
sheath 402 to
the base 404 allows the person to more easily sec through the aperture 424. In
an
embodiment, providing the fluid collection assembly 400 with the base 404 not
attached
to the sheath 402 may allow the sheath 402 to be attached to the base 404
depending on
the position of the individual. For instance, the angle at which the sheath
402 extends
from the base may vary depending on whether the individual is laying on the
individual's
back or side.
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[0073]
FIG. 4B is a cross-sectional schematic of the bast 404 shown in FIG. 4A,
according to an embodiment. Except as otherwise disclosed herein, the base 404
may be
substantially similar to any of the bases disclosed herein, such as the base
104 illustrated
in FIG. IF. For example, the base 404 may include a substrate 446 defining a
top surface
448 and a bottom surface 450. The base 404 may include a first adhesive layer
452
attached to at least a portion of the bottom surface 450 and a first release
liner 453
attached to the first adhesive layer 452. The first release liner 453 is
configured to be
easily removed from the first adhesive layer 452 and is configured to prevent
the first
adhesive layer 452 inadvertently becoming attached to an object.
[0074] The base 404
also include a second adhesive layer 460 on at least a portion of
the top surface 448 of the substrate 446. Generally, the second adhesive layer
460 is
disposed on, at most, the portions of the top surface 448 that are adjacent to
the sheath
402 after the sheath 402 is attached to the base 404 thereby preventing a
portion of the
second adhesive layer 460 being exposed after attaching the sheath 402 to the
base 404.
The second adhesive layer 460 may include any of the adhesives disclosed
herein or any
other suitable adhesive and is configured to form the permanent attachment
between the
sheath 402 and the base 404. The base 404 may also include a second release
liner 462
disposed on the second adhesive layer 460. The second release liner 462 is
configured to
be easily removed from the second adhesive layer 460 and is configured to
prevent the
second adhesive layer 460 inadvertently becoming attached to an object.
[0075]
It is noted that, in some embodiments, the second adhesive layer 460 and
the
second release liner 462 may be omitted from the base 404. For example, the
base 404
may be configured to be permanently attached to the sheath 402 using tape
(e.g., double-
sided tape), glue, or any other suitable attachment technique.
[0076] The
embodiments of fluid collection assemblies disclosed above are formed
from a first panel and a second panel that are distinct sheets. As previously
discussed,
forming the first panel and the second panel from distinct sheets may allow
the first panel
to be at least partially opaque while the second panel is at least partially
transparent.
Thus, the first panel may obstruct viewing the penis and whether there are
bodily fluids in
the chamber thereby increasing patient privacy while the second panel allows
examination of the penis. However. forming the first and second panels from
distinct
sheets may form edges that may cause patient discomfort and requires a
significant
amount of manufacturing (e.g., welding or other attachment technique) to
attach the first
panel to the second panel. As such, in other embodiments, the fluid collection
assemblies
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disclosed herein may be formed from first and second panels that are
integrally formed
together (e.g., exhibit single piece construction) which may eliminate at
least some of the
edges and simplify manufacturing of such fluid collection assemblies. For
example, FIG.
is a cross-sectional schematic view of a fluid collection assembly 500 that
includes a
5 first panel 508 and a second panel 510 integrally formed together,
according to an
embodiment. Except as otherwise disclosed herein, the fluid collection
assembly 500
may be the same or substantially similar to any of the fluid collection
assemblies
disclosed herein. For example, the fluid collection assembly 500 includes a
sheath 502
and a base (not shown). The sheath 502 at least defines a chamber 512, an
opening (not
shown), and a fluid outlet (not shown). The fluid collection assembly 500 also
includes at
least one porous material 522 disposed in the chamber 512.
[0077]
As previously discussed, the first panel 508 and the second panel 510 are
integrally formed together. As such, the first panel 508 and the second panel
510 are
different regions of fluid impermeable barrier 502 instead of different sheets
that are
attached together. The first panel 508 is the region of the fluid impermeable
barrier 502
adjacent to the porous material 522 while the second panel 510 is the region
of the fluid
impermeable barrier 502 adjacent to the penis receiving area 532 (shown in a
non-
collapsed state for illustrative purposes).
[0078]
In an embodiment, as illustrated, the first and second panels 508, 510 are
formed from a thin walled tube, such as thin walled tube formed using a blown
film
extrusion process. Forming the first and second panels 508, 510 from the thin
walled
tube precludes the need to attach the longitudinal edges of the first and
second panels 508,
510 together. However, the portions of the first and second panels 508, 510
that form the
proximal end region and the distal end region thereof may need to be attached
together
using any of the techniques disclosed herein. As such, forming the first and
second
panels 508, 510 from a thin walled tube makes manufacturing of the fluid
collection
assembly 500 more efficient since fewer portions of the first and second
panels 508, 510
need to be attached together. Further, forming the first and second panels
508, 510 from
the thin walled tube decreases the number of edges that may press into the
individual
compared to forming the first and second panels 508, 510 from two distinct
sheets.
[0079]
In an embodiment, the first and second panels 508, 510 are formed from a
single sheet that is folded. Forming the first and second panels 508, 510 from
the single
folded sheet precludes the need to attach one of the longitudinal edges of the
first and
second panels 508, 510 together. However, the portions of the first and second
panels
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508, 510 that form the proximal end region, the distal end region, and the
portion opposite
the fold may need to be attached together using any of the attachment
techniques
disclosed herein. Thus, forming the first and second panels 508, 510 from a
single folded
sheet makes manufacturing of the fluid collection assembly 500 more efficient
and
decreases the number of edges that are formed compared to forming the first
and second
panels 508, 510 from two distinct sheets. It is noted that, in either
embodiment, the first
panel 508 and the second panel 510 may still lie substantially flat when the
penis is not in
the chamber 512.
[0080]
In an embodiment, the second panel 510 may have an opening formed therein.
For example, the second panel 510 may have a cutout formed therein that is
spaced from
or extends inwardly from an outer edge of the second panel 510 (e.g., an outer
edge of the
thin walled tube or the single folded sheet). In such an example, the opening
may be
substantially similar to the opening 114 of FIGS. IB. 1C, and 1E. In an
embodiment, a
portion of the edges of the first and second panels 508, 510 at the proximal
end region
thereof are not attached together and first and second panels 508, 510
collectively define
the opening. In such an embodiment, the opening may be substantially similar
to the
opening 214 shown in FIG. 2A.
[0081]
As previously discussed, the fluid collection assemblies disclosed herein
may
be used with a buried penis and a non-buried penis. FIGS. 6A and 6B are cross-
sectional
schematics illustrating how substantially similar fluid collection assemblies
may be used
with a buried and non-buried penis, according to an embodiment. Referring to
FIG. 6A,
a first individual 664a has a buried penis 666a (shown schematically as a
slight bump).
The fluid collection assembly 600a is attached to the first individual 664a.
The fluid
collection assembly 600 is illustrated as being substantially the same as
fluid collection
assembly 100 shown in FIGS. IA-1D. However, it is noted that the fluid
collection
assembly 600a may include any of the fluid collection assemblies disclosed
herein. The
fluid collection assembly 600a is attached to the first individual 664a such
that the
aperture of the base 604a and the opening of the sheath 602a is adjacent to
the buried
penis 666a. Since the fluid collection assembly 600a lies substantially flat,
the porous
material 622a is generally adjacent to the opening and may only be spaced from
the
buried penis 666a by the thickness of the base 604a which prevents almost no
space for
the bodily fluids to pool before being received by the porous material 622a.
Is noted that
the porous material 622a may be spaced from the buried penis 666a by a
distance that is
less than the thickness of the base 604a (e.g., the porous material 622a
bulges into the
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aperture) or slightly greater than the thickness of the base 604a (e.g., the
testicles 668a
cause a bulge that pushes the porous material 622a away from the opening 614a
or the
porous material 622a exhibits a non-sheet like shape).
[0082]
Referring to FIG. 6B, a second individual 66411 has a non-buried penis
666b.
A fluid collection assembly 60011 that is the same or substantially the same
as the fluid
collection assembly 600a is attached to the second individual 664b. The fluid
collection
assembly 600b is attached to the second individual 664b such that the penis
656b extends
through the aperture of the base 604b and through the opening of the sheath
602b. Due to
the flexibility of the fluid collection assembly 600b, the sheath 602b can
receive the penis
therein.
[0083]
FIG. 7 is a block diagram of a system 770 for fluid collection, according
to an
embodiment. The system 770 includes a fluid collection assembly 700, a fluid
storage
container 772, and a vacuum source 774. The fluid collection assembly 700, the
fluid
storage container 772, and the vacuum source 774 may be fluidly coupled to
each other
via one or more conduits 736. For example, fluid collection assembly 700 may
be
operably coupled to one or more of the fluid storage container 772 or the
vacuum source
774 via the conduit 736. Bodily fluids (e.g., urine or other bodily fluids)
collected in the
fluid collection assembly 700 may be removed from the fluid collection
assembly 700 via
the conduit 736 which protrudes into the fluid collection assembly 700.
Suction force
may be introduced into the chamber of the fluid collection assembly 700 via
the inlet of
the conduit 736 responsive to suction (e.g., vacuum) force applied at the
outlet of the
conduit 736.
[0084]
The suction force may be applied to the outlet of the conduit 736 by the
vacuum source 774 either directly or indirectly. The suction force may be
applied
indirectly via the fluid storage container 772. For example, the outlet of the
conduit 736
may be disposed within the fluid storage container 772 and an additional
conduit 736 may
extend from the fluid storage container 772 to the vacuum source 774.
Accordingly, the
vacuum source 774 may apply suction to the fluid collection assembly 700 via
the fluid
storage container 772. The suction force may be applied directly via the
vacuum source
774. For example, the outlet of the conduit 736 may be disposed within the
vacuum
source 774. An additional conduit 736 may extend from the vacuum source 774 to
a
point outside of the fluid collection assembly 700, such as to the fluid
storage container
772. In such examples, the vacuum source 774 may be disposed between the fluid
collection assembly 700 and the fluid storage container 772.
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[0085]
The fluid collection assembly 700 may be similar or identical to any of
the
fluid collection devices disclosed herein in one or more aspects. For example,
the fluid
collection assembly 700 may include a fluid impermeable barrier at least
partially
defining a chamber of the fluid collection assembly 700. The fluid impermeable
barrier
also defines an opening extending therethrough. The opening may be positioned
adjacent
to or have a penis positioned thercthrough. The fluid collection assembly 700
may
include at least one porous material disposed within the fluid impermeable
barrier. The
conduit 736 includes an inlet and an outlet, the outlet being fluidly coupled
to the fluid
storage container and the inlet being positioned at or near a portion of the
chamber
selected to be at a gravimetrically low point of the fluid collection assembly
700 when
worn.
[0086]
The fluid storage container 772 is sized and shaped to retain a fluid
therein.
The fluid storage container 772 may include a bag (e.g., drainage bag), a
bottle or cup
(e.g., collection jar), or any other enclosed container for storing the bodily
fluids. In some
examples, the conduit 736 may 736 extend from the fluid collection assembly
700 and
attach to the fluid storage container 772 at a first point therein. An
additional conduit 736
may attach to the fluid storage container 772 at a second point thereon and
may extend
and attach to the vacuum source 774. Accordingly, a vacuum (e.g., suction) may
be
drawn through fluid collection assembly 700 via the fluid storage container
772. Fluid,
such as urine, may be drained from the fluid collection assembly 700 using the
vacuum
source 774.
[0087]
The vacuum source 774 may include one or more of a manual vacuum pump,
and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement
pump,
a magnetically driven pump, a peristaltic pump, or any pump configured to
produce a
vacuum. The vacuum source 774 may provide a vacuum or suction to remove fluid
from
the fluid collection assembly 700. In some examples, the vacuum source 774 may
be
powered by one or more of a power cord (e.g., connected to a power socket),
one or more
batteries, or even manual power (e.g., a hand operated vacuum pump). In some
examples, the vacuum source 774 may be sized and shaped to fit outside of, on,
or within
the fluid collection assembly 700. For example, the vacuum source 774 may
include one
or more miniaturized pumps or one or more micro pumps. The vacuum sources 774
disclosed herein may include one or more of a switch, a button, a plug, a
remote, or any
other device suitable to activate the vacuum source 774.
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[0088]
FIG. 8 is a flow diagram of a method 800 to collect fluid, according to an
embodiment. The method 800 of collecting fluid may utilize use any of the
fluid
collection assemblies and/or fluid collection systems disclosed herein. The
method 800
may include act 810, which recites "positioning an opening of a fluid
collection assembly
adjacent to or around a penis." Act 810 may be followed by act 820, which
recites
"receiving bodily fluids from the penis into a chamber of the fluid collection
assembly."
[0089]
Acts 810 and 820 of the method 800 are for illustrative purposes. For
example, the acts 810 and 820 of the method 800 may be performed in different
orders,
split into multiple acts, modified, supplemented, or combined. In an example,
one or
more of the acts 810 or 820 of the method 800 may be omitted from the method
800.
[0090]
Act 810 recites "positioning an opening of a fluid collection assembly
adjacent
to or around a penis." The act 810 of positioning an opening of a fluid
collection
assembly may include utilizing any of the fluid collection assemblies or
systems disclosed
herein. In some examples, act 810 may include positioning the opening such
that the
porous material of the fluid collection assembly extends across the opening
which allows
the porous material to abut or be positioned proximate to a buried penis. In
some
examples, act 810 may include positioned a base of a fluid collection assembly
over a
buried penis such that the male urethra is positioned adjacent to an aperture
of the base
and an opening of the sheath. In such an example, act 810 may include
positioning a
sheath of the male fluid collection assembly around a non-buried penis, such
that at least
a portion of the penis is positioned through an opening of the sheath and in
the chamber
of the fluid collection assembly.
[0091]
Act 820 recites, "receiving bodily fluids from the penis into a chamber of
the
fluid collection assembly." In some examples, receiving bodily fluids from the
penis into
a chamber of the fluid collection assembly includes receiving the bodily
fluids through
the opening of the fluid collection assembly. Receiving bodily fluids from the
penis into
a chamber of the fluid collection assembly may include at least one of
wicking,
absorbing, or adsorbing the bodily fluids away from the opening using the
porous
material. In some examples, receiving bodily fluids from the penis into a
chamber of the
fluid collection assembly may include receiving the bodily fluids into the
chamber of the
sheath of the fluid collection assembly. Receiving bodily fluids from the
penis into a
chamber of the fluid collection assembly may include flowing the bodily fluids
towards a
portion of the chamber that is fluidly coupled to an inlet of a conduit in
fluid
communication a vacuum source. For instance, receiving bodily fluids from the
penis
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into a chamber of the fluid collection assembly may include flowing the bodily
fluids to a
gravimetrically low point of the chamber, etc., such as via gravity, wicking,
or suction
force.
[0092]
The method MO may include applying suction with a vacuum source effective
to suction the bodily fluids from the chamber via a conduit disposed or
otherwise in fluid
communication with the chamber. The conduit may also be fluidly coupled to the
vacuum source may include using any of the vacuum sources disclosed herein.
Applying
suction with a vacuum source may include activating the vacuum source (e.g.,
suction
device) in fluid communication with the inlet of the conduit in the fluid
collection
assembly. In some examples, activating the vacuum source in fluid
communication with
the inlet of the conduit in the fluid collection assembly may include
supplying power to
the vacuum source by one or more of flipping an on/off switch, pressing a
button,
plugging the vacuum source into a power outlet, putting batteries into the
vacuum source,
etc. In some examples, the vacuum source may include a hand operated vacuum
pump
and applying suction with a vacuum source may include manually operating the
hand
operated vacuum pump effective to suction the bodily fluids from the chamber
via the
conduit disposed therein that is fluidly coupled to the vacuum source.
[0093]
In some examples, applying suction with a vacuum source effective to
suction
the bodily fluids from the chamber via a conduit disposed therein and fluidly
coupled to
the vacuum source may be effective to remove at least some bodily fluids from
the
chamber of the fluid collection assembly. In some examples, applying suction
with a
vacuum source effective to suction the bodily fluids from the chamber via a
conduit
disposed therein and fluidly coupled to the vacuum source may be effective to
transfer at
least some of the bodily fluids from the chamber to a fluid storage container
(e.g., a bottle
or bag).
[0094]
In some examples, the vacuum source (e.g., suction device) may be disposed
on or within the fluid collection assembly and applying suction with the
vacuum source
may include activating the vacuum source. In some examples, the vacuum source
may be
spaced from the fluid collection assembly and applying suction with the vacuum
source
may include activating the vacuum source.
[0095]
In some examples, applying suction with a vacuum source effective to
suction
the bodily fluids from the chamber via a conduit disposed therein and fluidly
coupled to
the vacuum source may include detecting moisture in the chamber (e.g., via one
or more
moisture sensors) and responsive thereto, activating the vacuum source to
provide suction
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in the chamber. The control of the vacuum source responsive to the signals
indicating
that moisture or a level thereof is present in the chamber may be automatic,
such as via a
controller (e.g., computer programmed to perform the operation), or may merely
provide
an indication that a level of moisture is present that may necessitate removal
of bodily
fluids from the chamber of the fluid collection assembly. In the latter case,
a user may
receive the indication (e.g., from the controller) and activate the vacuum
pump manually.
[0096]
In an example, the method 800 may include collecting the bodily fluids
that
are removed from the fluid collection assembly, such as into a fluid storage
container that
is spaced from the fluid collection assembly and fluidly coupled to the
conduit. The fluid
storage container may include any of the fluid storage containers disclosed
herein.
[0097]
FIG. 9 is a flow diagram of a method 900 to manufacture a fluid collection
assembly, according to an embodiment. The method 900 may be used to
manufacture at
least some of the fluid collection assemblies and/or fluid collection systems
disclosed
herein. The method 900 may include act 910, which recites "attaching a first
panel and
the second panel together along at least a portion of edges thereof to form a
sheath." Act
910 may be followed by act 920, which recites "disposing at least one porous
material in
a chamber defined between the first panel and the second panel."
[0098]
Acts 910, 920 of the method 900 are for illustrative purposes. For
example,
the acts 910, 920 of the method 900 may be performed in different orders,
split into
multiple acts, modified, supplemented, or combined. In an example, one or more
of the
acts 910, 920 of the method 900 may be omitted from the method 900. Any of the
acts
910 or 920 may include using any of the fluid collection devices or systems
disclosed
herein.
[0099]
Act 910 recites "attaching at least a portion of a first panel and at
least a
portion of the second panel together along at least a portion of edges thereof
to form a
sheath." In an example, when the first and second panels are distinct sheets,
act 910 may
include positioning the first panel and the second panel adjacent to each
other (e.g., on top
of each other). Positioning the first panel and the second panel adjacent to
each other
forms a chamber between the first panel and the second panel. After
positioning the first
and second panels, the first and second panels may be attached to each other,
such as
attached to each other along at least a portion of the outer edges thereof.
For instance, all
of the outer edges of the first and second panels may be attached together
except for
portions of the outer edges thereof that define an opening configured to
receive a penis (if
the opening is not completely defined by one of the first or second panels)
and a fluid
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outlet. In an example, the first and second panels are integrally formed
together. In such
an example, act 910 may include attaching edges of the first and second panels
that are
not already attached. When the first and second panels are formed by a thin
walled tube,
act 910 may include attaching the portions of the first and second panels that
form the
proximal and distal end regions thereof together. When the first and second
panels are
formed by a single folded sheet, act 910 may include attaching the portions of
the first
and second panels that form the proximal and distal end regions thereof
together and
attaching the portions of the first and second panels that are opposite the
fold.
[00100] The first and second panels may be attached together using any
suitable
technique. In an embodiment, the first and second panels are attached together
by sewing
the first and second panels together. In an embodiment, the first and second
panels are
attached together using a non-sewing technique, such as via heat sealing, RF
welding, or
US welding. Using a non-sewing technique to attach the first and second panels
together
may increase the rate of manufacture of the fluid collection assembly formed
during the
method 900. For example, heat sealing, RF welding, or US welding may be
performed
significantly faster than sewing the first and second panels together.
Further, heat sealing,
RF welding, or US welding may form better water proof seals compared to
sewing.
[00101]
Act 920 recites "disposing at least one porous material in a chamber
defined
between the first panel and the second panel." In an embodiment, the porous
material
may be attached to one of the first or second panels (e.g., with an adhesive,
heat sealing,
RF welding, US welding, or any other suitable technique) before act 910. In
such an
embodiment, positioning the first and second panels adjacent to each other
also disposes
the porous material in the chamber. In an embodiment, the porous material may
be
positioned between the first and second panels when the first and second
panels are
positioned adjacent to each other. In other words, the first panel, the porous
material, and
the second panel may form a stack with the porous material positioned between
the first
and second panels. Act 920 may also attach the porous materials to the first
and second
panels as the first and second panels are attached together. As such, the
method 900 does
not require a separate act of attaching the porous material to the first and
second panels
thus making the method 900 more efficient and quicker. In an embodiment, the
porous
material is disposed in the chamber after attaching the first and second
panels together. In
such an embodiment, the porous material may be attached to one or more of the
first or
second panels with an adhesive, tape, or the like or the porous material may
not be
attached to the first and second panels. While not attaching the porous
material to the
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first and second panels may make the method 900 more efficient and quicker,
the porous
material may move in the chamber, such as by bunching up near the outlet.
[00102] In an embodiment, the method 900 may include forming one or more of
the
first panel, the second panel, and the porous material. In an example, the
method 900
may form the first and second panel, for example, by stamping the first and
second panels
(including any openings, cutouts, or perforation defined thereby). Stamping
the first and
second panels and attaching the first and second panels together, as discussed
above, may
be quicker and easier than forming a single sheet into a cylinder. In an
example, the
porous material may also be stamped from a sheet of the porous material when
the porous
material exhibits a sheet-like shape. In an example, the first and second
panel may be
formed using a blown film extrusion technique to form a thin walled tube. In
an example,
at least one of the first panel, the second panel, or the porous material may
be formed by
non-stamping techniques or non-blown film extrusion technique even though such
techniques may be more complicated or time consuming. Examples of non-stamping
and
non-blown film extrusion techniques include cutting with a blade, other
extrusion
techniques, molding (e.g., cast molding), or any other suitable technique.
[00103] In an embodiment, the method 900 may include forming the base. In an
example, the base may be formed by stamping the base from a sheet (e.g., a
sheet that
includes a substrate, at least one adhesive layer, and at least one release
liner). The base
may be formed by stamping since, for instance, the base is formed from a thin
film and
the base may not include any protrusions, such as a ring-like protrusion
defining the
aperture. Alternatively, the base may be formed by injection molding, or any
other
suitable technique even though non-stamping techniques may be more time
consuming.
[00104] In an embodiment, the method 900 may include permanently attaching the
base to the sheath formed at least partially by acts 910 and 920. In an
example, the
method 900 includes permanently attaching the base to the sheath before
providing the
fluid collection assembly to an end user. In such an example, the method 900
may
include permanently attaching the base to the sheath and, after attaching the
base to the
sheath, disposing the fluid collection assembly in a package. In an example,
the method
900 does not include permanently attaching the base to the sheath before
providing the
fluid collection assembly to an end user. In such an example, the method 900
may
include disposing the fluid collection assembly, with the sheath and the base
not attached
together, in a package. The end user may remove the fluid collection assembly
from the
package and may permanently attaching the base to the sheath after removing
the fluid
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collection assembly from the package. For instance, the end user may
permanently attach
the sheath to the base before, during, or after attaching the base to the skin
surround the
penis.
[00105]
It is noted that the embodiments disclosed above relate to fluid
collection
assemblies configured to collection bodily fluids from a male. However, it is
noted that
such fluid collection assemblies may also be used to collection bodily fluids
from a
female since the urethral opening of the female is, functionally, similar to a
buried penis.
[00106] While various aspects and embodiments have been disclosed herein,
other
aspects and embodiments are contemplated. The various aspects and embodiments
disclosed herein are for purposes of illustration and are not intended to be
limiting.
[00107]
Terms of degree (e.g., "about," "substantially," "generally," etc.)
indicate
structurally or functionally insignificant variations. In an example, when the
term of
degree is included with a term indicating quantity, the term of degree is
interpreted to
mean 10%, 5%, or +2% of the term indicating quantity. In an example, when
the term
of degree is used to modify a shape, the term of degree indicates that the
shape being
modified by the term of degree has the appearance of the disclosed shape. For
instance,
the term of degree may be used to indicate that the shape may have rounded
corners
instead of sharp corners, curved edges instead of straight edges, one or more
protrusions
extending therefrom, is oblong, is the same as the disclosed shape, etc.
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