U.S. patent application number 17/446246 was filed with the patent office on 2022-03-03 for systems and methods including a male fluid collection device and a securement element.
The applicant listed for this patent is PureWick Corporation. Invention is credited to Ashley Marie Johannes, Martyn Mitchell, Samuel Edmund Whittome, Leanne Yip Heung Win.
Application Number | 20220062026 17/446246 |
Document ID | / |
Family ID | |
Filed Date | 2022-03-03 |
United States Patent
Application |
20220062026 |
Kind Code |
A1 |
Mitchell; Martyn ; et
al. |
March 3, 2022 |
SYSTEMS AND METHODS INCLUDING A MALE FLUID COLLECTION DEVICE AND A
SECUREMENT ELEMENT
Abstract
Example male fluid collection devices and methods of collecting
fluid are described. The fluid collection devices include a body
defining a chamber sized to receive at least a head of a penis
therein, one or more securement elements configured to secure the
body to the penis, and a conduit in fluid communication with the
chamber.
Inventors: |
Mitchell; Martyn;
(Hertfordshire, GB) ; Win; Leanne Yip Heung;
(Middlesex, GB) ; Whittome; Samuel Edmund;
(Cambridge, GB) ; Johannes; Ashley Marie;
(Statham, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PureWick Corporation |
El Cajon |
CA |
US |
|
|
Appl. No.: |
17/446246 |
Filed: |
August 27, 2021 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
63073545 |
Sep 2, 2020 |
|
|
|
International
Class: |
A61F 5/453 20060101
A61F005/453; A61F 5/44 20060101 A61F005/44 |
Claims
1. A male fluid collection device, comprising: a body defining a
chamber sized to receive at least a head of a penis therein; one or
more securement elements configured to secure the body to the
penis; and a conduit in fluid communication with the chamber.
2. The male fluid collection device of claim 1, further comprising:
wherein the body includes a tubular body including the chamber
sized to receive and interface the penis therein and a fluid
impermeable barrier housing a liquid or gel, the tubular body being
configured to roll onto the penis as the penis is inserted into the
chamber and interfaces the tubular body within the chamber to
position at least a portion of the penis in the chamber; wherein
the one or more securement elements include at least a clip
configured to clip around the tubular body and stop the tubular
body from rolling when the penis is positioned within with the
tubular body effective to secure the tubular body to the penis; and
a sump secured to at least one of the clip or the tubular body and
configured to collect fluid discharged from the penis when the
penis is positioned within the tubular body, the sump including an
aperture configured to receive the conduit effective and provide
fluid communication between the chamber and the conduit.
3. The male fluid collection device of claim 2, wherein: the sump
is secured to the clip and includes a fluid impermeable layer
defining the aperture and a fluid permeable material positioned on
the fluid impermeable layer and configured to wick fluid towards
the aperture; and the tubular body includes a fluid permeable
material positioned on the tubular body to interface and move with
the head of the penis as the penis is inserted into the chamber of
the tubular body, the fluid permeable material of the tubular body
configured to wick fluid away from the penis towards the conduit
when the tubular body is secured to the penis with the clip.
4. The male fluid collection device of claim 1, wherein: the body
includes at least a fluid impermeable layer, an opening sized and
dimensioned to receive at least the head of the penis, and an
aperture distal to the opening and configured to receive the
conduit effective to provide fluid communication between the
chamber and the conduit; and the one or more securement elements
include at least one inflatable ring secured to the body and
including a valve configured to receive air to inflate the at least
one inflatable ring and exhaust air to deflate the at least one
inflatable ring, wherein inflation of the at least one inflatable
ring decreases an inner diameter of the at least one inflatable
ring effective to secure the body to the penis.
5. The male fluid collection device of claim 4, wherein: the at
least one inflatable ring is positioned within the chamber defined
by the body and interfaces the penis when the penis is positioned
within the chamber and the at least one inflatable ring is
inflated; and the fluid impermeable layer of the body includes an
inflation inlet providing fluid communication with the valve.
6. The male fluid collection device of claim 5, further comprising
a fluid permeable layer positioned within the chamber at least
distal to the opening and configured to wick fluids discharged from
the penis to the conduit, wherein the fluid permeable layer extends
at least to the at least one inflatable ring and the at least one
inflatable ring is positioned between (1) the fluid permeable layer
and the fluid impermeable layer or (2) the at least one inflatable
ring and the fluid impermeable layer.
7. The male fluid collection device of claim 1, wherein: the body
includes: a tubular portion including an open cell foam; and a
fluid impermeable cap secured to the tubular portion and including
an aperture distal to the tubular portion, the fluid impermeable
cap and the tubular portion defining the chamber and the aperture
being configured to receive the conduit effective to provide fluid
communication between the chamber and the conduit; and the one or
more securement elements include an adjustable strap positioned and
configured to tighten around the tubular portion to secure the body
to the penis when at least a portion of the penis is positioned
within the chamber, wherein the tubular portion is secured to the
fluid impermeable cap effective to allow air to flow into chamber
through the open cell foam when a vacuum is pulled in the chamber
through the conduit.
8. The male fluid collection device of claim 7, wherein: the
adjustable strap includes at least one of an elastic adjustable
strap, a hose clamp, a hook and loop fastener material, or one or
more fasteners; and the tubular portion includes a shore A
durometer of less than about 20.
9. The male fluid collection device of claim 7, further comprising
a fluid permeable material secured to the fluid impermeable cap
within the chamber and configured to wick fluid discharged from the
penis towards the conduit.
10. The male fluid collection device of claim 1, wherein: the one
or more securement elements include one or more inflatable bags
positioned within the chamber and including a valve configured to
receive air to inflate the one or more inflatable bags and exhaust
air to deflate the one or more inflatable bags, wherein inflation
of the one or more inflatable bags decreases an inner diameter of
the fluid collection device effective to secure the body to the
penis; and the body includes at least a fluid impermeable layer, an
opening sized and dimensioned to receive at least the head of the
penis, an aperture distal to the opening and configured to receive
the conduit effective to provide fluid communication between the
chamber and the conduit; and an inflation inlet positioned to
provide fluid communication with the valve.
11. The male fluid collection device of claim 10, wherein the one
or more inflatable bags interface the head of the penis and a shaft
of the penis when the penis is positioned within the chamber and
the one or more inflatable bags are inflated.
12. The male fluid collection device of claim 11, wherein the one
or more inflatable bags include multiple inflatable bags in fluid
communication with one another.
13. The male fluid collection device of claim 10, further
comprising a fluid permeable layer positioned within the chamber at
least distal to the opening and configured to wick fluids
discharged from the penis to the conduit, wherein the fluid
permeable layer extends at least to the one or more inflatable
bags, and (1) the one or more inflatable bags are positioned
between the fluid permeable layer and the fluid impermeable layer
or (2) the fluid permeable layer is positioned between the one or
more inflatable bags and the fluid impermeable layer.
14. The male fluid collection device of claim 1, wherein: the body
includes at least a fluid impermeable layer, an opening sized and
dimensioned to receive at least the head of the penis, and an
aperture distal to the opening and configured to receive the
conduit effective to provide fluid communication between the
chamber and the conduit; and the one or more securement elements
include a drawstring secured to the body.
15. The male fluid collection device of claim 14, further
comprising a fluid permeable layer positioned within the chamber at
least distal to the opening and configured to wick fluids
discharged from the penis to the conduit.
16. The male fluid collection device of claim 1, wherein: the body
includes: a tubular portion including an inner surface and a
plurality of projections extending inwardly from the inner surface;
and a fluid impermeable cap secured to the tubular portion and
including an aperture distal to the tubular portion, the fluid
impermeable cap and the tubular portion defining the chamber and
the aperture being configured to receive the conduit effective to
provide fluid communication between the chamber and the conduit;
and the one or more securement elements include an adjustable strap
positioned and configured to tighten around the tubular portion to
secure the body to the penis when at least a portion of the penis
is positioned within the chamber.
17. The male fluid collection device of claim 16, wherein: the
adjustable strap includes at least one of an elastic adjustable
strap, a hose clamp, a hook and loop fastener material, or one or
more fasteners; the tubular portion includes an elastomeric
material; the plurality of projections have a shore A durometer of
about 30 to about 60 and include one or more of an elastomer, a
silicone, a thermoplastic elastomer, or thermoplastic
polyurethane.
18. The male fluid collection device of claim 1, wherein: the body
includes: a tubular portion including at least one of a breathable
fabric material or an open cell hydrophobic foam; and a fluid
impermeable cap secured to the tubular portion and including an
aperture distal to the tubular portion, the fluid impermeable cap
and the tubular portion defining the chamber and the aperture being
configured to receive the conduit effective to provide fluid
communication between the chamber and the conduit; and the one or
more securement elements include a hook and loop material fastener
strap positioned and configured to tighten around the tubular
portion to secure the body to the penis when at least a portion of
the penis is positioned within the chamber.
19. The male fluid collection device of claim 1, wherein: the body
includes: a tubular portion; and a fluid impermeable cap secured to
the tubular portion and including an aperture distal to the tubular
portion, the fluid impermeable cap and the tubular portion defining
the chamber and the aperture being configured to receive the
conduit effective to provide fluid communication between the
chamber and the conduit; and the one or more securement elements
include one or more worm drive hose clamps positioned and
configured to tighten around the tubular portion to secure the body
to the penis when at least a portion of the penis is positioned
within the chamber.
20. The male fluid collection device of claim 1, wherein: the body
includes a cup-shaped body sized to receive at least the penis
therein, the cup-shaped body including a fluid impermeable layer
defining the chamber, a perimeter, an open cell hydrophobic foam
seal on the perimeter, an aperture configured to receive the
conduit effective to provide fluid communication between the
chamber and the conduit, a fluid permeable material positioned
within the chamber and configured to direct fluid discharged from
the penis to the conduit; and the one or more securement elements a
garment having one or more bands configured to wrap around the user
and a support material attached to the one or more straps and
configured to secure the body between the support material and the
user.
21. The male fluid collection device of claim 20, further
comprising a reservoir of void space in the chamber around the
aperture, wherein the cup-shaped body is sized to receive the penis
and testicles of the user therein and the garment includes a jock
strap garment.
22. The male fluid collection device of claim 1, wherein: the body
includes a fluid impermeable layer including a first region having
an inner surface and an outer surface, a second region having an
inner surface and an outer surface, a slot separating two portions
of the second region, and a fluid permeable layer secured to the
inner surface of the two portions of the second region; and the one
or more securement elements include an adhesive strip secured to
the inner surface of the first region and a different adhesive
strip secured to the inner surface of each of the two portions of
the second region distal to the first region, wherein the first
region of the body is configured to wrap around at least the head
of the penis with the adhesive strip of the first region secured to
the outer surface of the first region to define at least a portion
of the chamber, the two portions of the second region are
configured to fold towards the first region with the different
adhesive strip of each of the two portions of the second region
secured to the outer surface of the first region to position the
fluid permeable layer proximate to the head of the penis, and the
conduit extends through the slot into the chamber.
23. A method of collecting fluid from a male, the method
comprising: positioning a head of a penis of a user within a
chamber defined by a body of a fluid collection device; securing
the body to the penis with one or more securement elements; and
receiving fluids discharged from the penis into the chamber of the
fluid collection device.
24. The method of claim 23, wherein: positioning a head of a penis
of a user within a chamber defined by a body of fluid collection
device includes inserting at least the head of the penis in the
chamber of a tubular body and rolling the tubular body onto the
penis, the tubular body including a fluid impermeable barrier
housing a liquid or gel; and securing the body to the penis with
one or more securement elements includes securing a clip around the
tubular body that stops the tubular body from rolling.
25. The method of claim 23, wherein: positioning a head of a penis
of a user within a chamber defined by a body of fluid collection
device includes inserting at least the head of the penis through at
least one inflatable ring secured to the body; and securing the
body to the penis with one or more securement elements includes
inflating the at least one inflatable ring to decrease an inner
diameter of the at least one inflatable ring and secure the body to
the penis.
26. The method of claim 23, further comprising: wherein positioning
a head of a penis of a user within a chamber defined by a body of
fluid collection device includes inserting at least the head of the
penis through a tubular portion including an open cell foam and
into a fluid impermeable cap secured to the tubular portion, the
fluid impermeable cap and the tubular portion defining the chamber;
wherein securing the body to the penis with one or more securement
elements includes securing an adjustable strap around the tubular
portion to secure the body to the penis when at least a portion of
the penis is positioned within the chamber; and pulling the fluid
in the chamber through the conduit with a vacuum force with air to
flowing into chamber through the open cell foam.
27. The method of claim 23, wherein securing the body to the penis
with one or more securement elements includes inflating one or more
inflatable bags within the chamber.
28. The method of claim 23, wherein securing the body to the penis
with one or more securement elements includes tightening a
drawstring secured to the body around the penis.
29. The method of claim 23, wherein securing the body to the penis
with one or more securement elements includes securing a hook and
loop material fastener strap around a tubular portion of the
body.
30. The method of claim 23, wherein securing the body to the penis
with one or more securement elements includes tightening one or
more worm drive hose clamps around a tubular portion of the
body.
31. The method of claim 23, wherein: positioning a head of a penis
of a user within a chamber defined by a body of fluid collection
device includes positioning the head of the penis within a chamber
defined by a cup-shaped body with an open cell hydrophobic foam
seal on a perimeter of the cup-shaped body positioned against the
user; and securing the body to the penis with one or more
securement elements includes positioning a support material of a
jock strap garment over the cup-shaped body within one more bands
of the jack strap garment wrapped around the user.
32. The method of claim 23, wherein: positioning a head of a penis
of a user within a chamber defined by a body of fluid collection
device includes wrapping a first region of the body around at least
the head of the penis; and securing the body to the penis with one
or more securement elements includes: securing an adhesive strip on
the inner surface of the first region to the outer surface of the
first region; folding two portions of a second region of the body
towards the first region; and securing different adhesive strips on
an inner surface of each of the two portions of the second region
to the outer surface of the first region to position a fluid
permeable layer on the two portions of the second region proximate
to the head of the penis, the conduit extending through a slot
between the two portions and into the chamber.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent
Application No. 63/073,545 filed on Sep. 2, 2020, the disclosure of
which is incorporated herein, in its entirety, by this
reference.
BACKGROUND
[0002] An individual may have limited or impaired mobility such
that typical urination processes are challenging or impossible. For
example, the individual may have surgery or a disability that
impairs mobility. In another example, the individual may have
restricted travel conditions such as those experienced by pilots,
drivers, and workers in hazardous areas. Additionally, fluid
collection from the individual may be needed for monitoring
purposes or clinical testing.
[0003] Bed pans and urinary catheters, such as a Foley catheter,
can be used to address some of these circumstances. However, bed
pans and urinary catheters have several problems associated
therewith. For example, bed pans can be prone to discomfort,
pressure ulcers spills, and other hygiene issues. Urinary catheters
be can be uncomfortable, painful, and can cause urinary tract
infections.
[0004] Thus, users and manufacturers of fluid collection devices
continue to seek new and improved devices, systems, and methods to
collect urine.
SUMMARY
[0005] Embodiments disclosed herein are directed to male fluid
collection devices and methods of collecting fluid from a male. In
an embodiment, a male fluid collection device includes a body
defining a chamber sized to receive at least a head of a penis
therein, one or more securement elements configured to secure the
body to the penis, and a conduit in fluid communication with the
chamber.
[0006] In an embodiment, a method of collecting fluid from a male
includes positioning a head of a penis of a user within a chamber
defined by a body of a fluid collection device. The method also may
include securing the body to the penis with one or more securement
elements. The method also may include receiving fluids discharged
from the penis into the chamber of the fluid collection device.
[0007] 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
[0008] 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.
[0009] FIG. 1 is an isometric view of a male fluid collection
device, according to an embodiment.
[0010] FIG. 2 is an isometric view of a male fluid collection
device, according to an embodiment.
[0011] FIG. 3A is an isometric front view of a male fluid
collection device, according to an embodiment.
[0012] FIG. 3B is a rear view of the male fluid collection device
of FIG. 3A.
[0013] FIG. 3C is a cross-sectional side view of the male fluid
collection device of FIG. 3A.
[0014] FIG. 3D is a front view of the male fluid collection device
of FIG. 3A and a securement element, according to an
embodiment.
[0015] FIG. 4A is an exploded isometric view of a male fluid
collection device, according to an embodiment.
[0016] FIG. 4B is an isometric view of the male fluid collection
device of FIG. 4B with a penis secured partially therein.
[0017] FIG. 5A is an isometric view of a male fluid collection
device, according to an embodiment.
[0018] FIG. 5B is a cross-sectional isometric view of the male
fluid collection device of FIG. 5A.
[0019] FIG. 6A is an isometric view of a male fluid collection
device, according to an embodiment.
[0020] FIG. 6B is a cross-sectional isometric view of the male
fluid collection device of FIG. 6A.
[0021] FIG. 7 is an isometric view of a male fluid collection
device, according to an embodiment.
[0022] FIG. 8 is an isometric view of a male fluid collection
device, according to an embodiment.
[0023] FIG. 9 is an isometric view of a male fluid collection
device, according to an embodiment.
[0024] FIG. 10 is an isometric view of a male fluid collection
device, according to an embodiment.
[0025] FIG. 11A is an unwrapped configuration of a male fluid
collection device, according to an embodiment.
[0026] FIG. 11B is a wrapped configuration of the male fluid
collection device of FIG. 11A.
[0027] FIG. 12 is a flow diagram of a method to collect fluid,
according to an embodiment.
[0028] FIG. 13 is a block diagram of a system for fluid collection,
according to an embodiment.
DETAILED DESCRIPTION
[0029] Embodiments disclosed herein are directed to systems and
methods including a male fluid collection device and a securement
element configured to secure the fluid collection device to a
penis. Conventional male fluid collection devices can be difficult
to retain on the penis during use. The embodiments of male fluid
collection devices disclosed herein include external catheters for
men that may be used as alternatives to condom catheters. The male
fluid collection devices also include a securement element
configured to secure the male fluid collection device to the penis
and retain the male fluid collection device in position to
collection fluid from the user with minimal (e.g. no) leakage. The
male fluid collection devices disclosed herein are configured to
collect fluids from an individual, such as urine, penile discharge,
reproductive fluids, blood, sweat, or other bodily fluids.
[0030] Fluid collection devices disclosed herein may be used in
fluid collection systems. The fluid collection systems may include
a fluid collection device, a fluid storage container, and a
portable vacuum source. Fluid (e.g., urine or other bodily fluids)
collected in the fluid collection device may be removed from the
fluid collection device via a conduit which is in fluid
communication with a chamber or an interior region of the fluid
collection device. For example, a first open end of the conduit may
extend into or have direct fluid communication with the chamber of
the fluid collection device. The second open end of the conduit may
extend into the fluid storage container or the portable vacuum
source. The suction force may be introduced into the interior
region of the fluid collection device via the first open end of the
conduit responsive to a suction (e.g., vacuum) force applied at the
second end of the conduit. The suction force may be applied to the
second open end of the conduit by the portable vacuum source either
directly or indirectly.
[0031] In some embodiments, the portable vacuum source may be
disposed in or on the fluid collection device. In such embodiments,
the conduit may extend from the fluid collection device and attach
to the portable vacuum source at a first point therein. An
additional conduit may attach to the portable vacuum source at a
second point thereon and may extend out of the fluid collection
device, and may attach to the fluid storage container. Accordingly,
a vacuum (e.g., suction) may be drawn through the fluid collection
device via the fluid storage container. Fluid, such as urine, may
be drained from the fluid collection device using the portable
vacuum source.
[0032] In many embodiments, a male fluid collection device includes
a body, one or more securement elements, and a conduit. The body
defines a chamber that is sized to receive at least a head of a
penis therein. The one or more securement elements are configured
to secure the body to the penis and the conduit is in fluid
communication with the chamber. FIG. 1 is an isometric view of a
fluid collection device 100 including a body having a tubular
portion 140 and a fluid impermeable cap 110 secured to the tubular
portion 140, a securement element 150, and a conduit 108. The
tubular portion 140 may include a foam material, such as an open
cell foam. In some embodiments, the foam material includes an open
cell hydrophobic foam material. The foam material allows air into
the system when vacuum is pulled through the conduit 108,
preventing undesirable suction directly on the skin of the penis
10.
[0033] The tubular portion 140 may include a material, such as a
foam material, having a low durometer that is soft when contacting
the penis. For example, the material of the tubular portion 140 may
have a shore A durometer of less than about 30, less than about 25,
less than about 20, less than about 15, less than about 10, about
10 to about 30, about 10 to about 20, about 15 to about 25, about
20 to about 30, about 10 to about 15, about 15 to about 20, about
20 to about 25, or about 25 to about 30. The material of the
tubular portion 140 also may include a high compression
material.
[0034] The tubular portion 140 may include a C-shaped cross-section
that has a slit 142 or gap that may be closed when tightened by the
securement element 150 to form an O-shaped tubular element. In some
embodiments, the tubular portion 140 includes an O-shaped
cross-section whether or not the securement element 150 has
tightened around the tubular portion 140 (e.g., the slit or gap is
absent from the tubular portion). The tubular portion 140 may
define at least a portion of the chamber 104. In some embodiments,
both the tubular portion 140 and the cap 110 may together define at
least a portion of the chamber 104. The tubular portion 140 also
defines or may otherwise include an opening 106 leading to the
chamber 104. The opening 106 and the chamber 104 are sized and
dimensioned to receive at least the head of the penis 10 when at
least a portion of the penis 10 is inserted into the fluid
collection device 100 through the opening 106. The opening 106 and
the chamber 104 may be sized and dimensioned to generally interface
the penis 10 as the penis is inserted into the fluid collection
device through to opening 106. In use, the tubular portion 140 may
be positioned around and/or interface at least a portion of the
head of the penis 10 and/or at least a portion of the shaft of the
penis 10 when the securement element 150 tightens around the
tubular portion 140.
[0035] The cap 110 is fluid impermeable and secured to the tubular
portion 140. In some embodiments, the cap 110 may be secured to the
tubular portion with one or more of an adhesive, chemical bonding,
welding (e.g., radio frequency welding or ultrasonic welding),
mechanically (e.g., clips or spikes), or friction fit. The cap 110
may temporarily store the fluids in a chamber 104 defined by the
cap 110. The cap 110 may be formed of any suitable fluid
impermeable materials, such as a fluid impermeable polymer (e.g.,
silicone, polypropylene, polyethylene, polyethylene terephthalate,
a polycarbonate, etc.), polyurethane films, thermoplastic elastomer
(TPE), rubber, thermoplastic polyurethane, another suitable
material, or combinations thereof. As such, the cap 110
substantially prevents the fluids from exiting the portions of the
chamber 104 that are spaced from the opening 106. The cap 110 may
be flexible, thereby enabling the fluid collection device 100 to
bend or curve when positioned against the body of a wearer. Example
fluid impermeable materials may include, but are not limited to, a
fluid impermeable material including at least one of Versaflex CL
2000X TPE, Dynaflex G6713 TPE, or Silpuran 6000/05 A/B silicone. In
some embodiments, the cap 110 may be generally rigid.
[0036] In some embodiments, the cap 110 may define an aperture 124
sized to receive the conduit 108 (e.g., at least one tube). The
aperture 124 may be generally opposite to the opening 106. The at
least one conduit 108 may be disposed in or have communication with
the chamber 104 via the aperture 124. The aperture 124 may be
configured to form an at least substantially fluid tight seal
against the conduit 108 or the at least one tube thereby
substantially preventing the fluids from escaping the chamber
104.
[0037] The cap also may include a fluid permeable layer 120
positioned in the chamber 104 of the cap 110 to be adjacent and/or
interface the urethra opening on the head of the penis 10. The
fluid permeable layer 120 may cover or extend across at least a
portion (e.g., all) of the chamber 104 in the cap 120. The fluid
permeable body 120 may be configured to wick any fluid away from
the penis 10 and the opening 106, thereby preventing the fluid from
escaping the chamber 104. The fluid permeable layer 120 also may
wick the fluid generally towards the conduit 108.
[0038] The fluid permeable layer 120 may include any material that
may wick the fluid. The permeable properties referred to herein may
be wicking, capillary action, diffusion, or other similar
properties or processes, and are referred to herein as "permeable"
and/or "wicking." Such "wicking" or other physical properties may
exclude absorption into the fluid permeable layer 120, such as not
include absorption of the bodily fluid into the fluid permeable
layer 120. Put another way, substantially no absorption or
solubility of the bodily fluids into the material may take place
after the material is exposed to the bodily fluids and removed from
the bodily fluids for a time. While no absorption or solubility is
desired, the term "substantially no absorption" may allow for
nominal amounts of absorption and/or solubility of the bodily
fluids into the fluid permeable body 120 (e.g., absorbency), such
as less than about 30 wt % of the dry weight of the fluid permeable
body 110, less than about 20 wt %, less than about 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 fluid permeable body 210. In an
embodiment, the fluid permeable body 210 may include at least one
absorbent or adsorbent material.
[0039] The fluid permeable layer 120 may include a one-way fluid
movement fabric. As such, the fluid permeable layer 120 may remove
fluid from the area around the penis 10, thereby leaving the penis
10 dry. The fluid permeable layer 120 may enable the fluid to flow
generally towards a reservoir 122 of void space formed within the
chamber 104. For example, the fluid permeable layer 120 may include
a porous or fibrous material, such as hydrophilic polyolefin. In
some embodiments, the fluid permeable layer 120 consists of or
consists essentially of a porous or fibrous material, such as
hydrophilic polyolefin. Examples of polyolefin that may be used in
the fluid permeable layer 120 include, but are not limited to,
polyethylene, polypropylene, polyisobutylene, ethylene propylene
rubber, ethylene propylene diene monomer, or combinations thereof.
The fluid permeable layer 120 may include varying densities or
dimensions. Moreover, the fluid permeable layer 120 may be
manufactured according to various manufacturing methods, such as
molding, extrusion, or sintering.
[0040] In some embodiments, the fluid permeable layer 120 includes
a singular and porous layer. In other embodiments, the fluid
permeable layer 120 may include two or more layers of fluid
permeable materials. For example, the fluid collection device 100
may include a fluid permeable membrane covering at least a portion
of a fluid permeable layer, with both the fluid permeable membrane
and the fluid permeable layer being disposed in the chamber 104.
The fluid permeable membrane may be configured to wick any fluid
away from the opening 106 and the penis 10, thereby preventing the
fluid from escaping the chamber 104. The permeable properties
referred to herein may be wicking, capillary action, diffusion, or
other similar properties or processes, and are referred to herein
as "permeable" and/or "wicking." In some embodiments, at least one
of the fluid permeable membrane or the fluid permeable support
include nylon configured to wick fluid away from the opening 106
and the penis 10. The material of the fluid permeable membrane and
the fluid permeable support also may include natural fibers. 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.
[0041] The fluid permeable membrane may also wick the fluid
generally towards the reservoir 122 and/or the conduit 108. The
fluid permeable membrane may include any material that may wick the
fluid. For example, the fluid permeable membrane may include
fabric, such as a gauze (e.g., a silk, linen, polymer based
materials such as polyester, or cotton gauze), another soft fabric
(e.g., jersey knit fabric or the like), or another smooth fabric
(e.g., rayon, satin, or the like). Forming the fluid permeable
membrane from gauze, soft fabric, and/or smooth fabric may reduce
chaffing caused by the fluid collection device 100. Other
embodiments of fluid permeable membranes, fluid permeable supports,
chambers, and their shapes and configurations are disclosed in U.S.
patent application Ser. No. 15/612,325 filed on Jun. 2, 2017; U.S.
patent application Ser. No. 15/260,103 filed on Sep. 8, 2016; U.S.
patent application Ser. No. 15/611,587 filed on Jun. 1, 2017; PCT
Patent Application No. PCT/US19/29608, filed on Apr. 29, 2019, the
disclosure of each of which is incorporated herein, in its
entirety, by this reference. In many embodiments, the fluid
permeable layer 120 includes a fluid permeable support including a
porous spun nylon fiber structure and a fluid permeable wicking
membrane including gauze at least partially enclosing the spun
nylon fiber structure. For example, the fluid permeable layer 120
may include a gauze or other wicking fabric positioned to contact
the skin of the user through the opening 106. In some embodiments,
the gauze or other wicking fabric is wrapped around a body of spun
nylon fibers material and/or covering both sides of a substantially
planar spun nylon fibers material. In some embodiments, the gauze
or other wicking fabric covers the side of substantially planar
spun nylon fibers material that is oriented towards the skin of the
user.
[0042] In the illustrated embodiment, the conduit 108 is direct
fluid communication with the chamber 104. For example, the conduit
108 may extend at least partially into the chamber 104 in the cap
110 through conduit 124. The aperture 124 may be configured to form
an at least substantially fluid tight seal against the conduit 108
or the at least one tube thereby substantially preventing the
fluids from escaping the chamber 104 (e.g., the reservoir 122). The
conduit may be generally flush or recessed from an inner surface of
the cap 110. In some embodiments, the cap 110 includes a port
defining the aperture 124, and conduit may be configured to
detachably secure to the port. For example, the port may protrude
from the cap 110 distal to the tubular portion 140 and the conduit
108 may slide onto and off of the port. The conduit 108 may include
a flexible material such as plastic tubing (e.g., medical tubing).
Such plastic tubing may include a thermoplastic elastomer,
polyvinyl chloride, ethylene vinyl acetate,
polytetrafluoroethylene, etc., tubing. In some embodiments, the
conduit 108 may include silicone or latex.
[0043] The cap 110 may store fluids in the reservoir 122 therein.
The reservoir 122 may be an unoccupied portion of the chamber 104
and is void of other material. In some embodiments, the reservoir
122 is defined at least partially by the fluid permeable layer 120
and the cap 110. In some embodiments, the reservoir 122 is absent,
and the fluid permeable layer 120 extends continuously from within
the chamber 104 to the aperture 124 and/or fill substantially all
of the cap 110. In use, the fluid permeable layer 120 may extend
continuously in the chamber from the penis 10 to the aperture
124.
[0044] The cap 110 may be sized and dimensioned to receive at least
a portion of the head of the penis 10. In some embodiments, the cap
110 is sized to receive the head of the penis 110 and at least a
portion of the shaft of the penis 10. When received into the
chamber 104 of the cap 110, at least a portion of the penis 10 may
interface at least a portion of the cap 110 and/or the fluid
permeable layer 120.
[0045] The securement element 150 is configured to position around
to interface the tubular portion 140. The securement element 150 is
configured to allow "on the fly" or personalized adjustment of the
securement element 150 during use. In some embodiments, the
securement element 150 is adjustable strap, such as an elastic
adjustable strap, a strap having a hose clamp, a strap having hook
and loop fastener materials, one or more fasteners, a clip, a
buckle, a strap having one or more adhesive portions, or
combinations thereof. In some embodiments, the securement element
150 may include an O-ring.
[0046] In operation, the penis may be inserted into the tubular
portion 140. In some embodiments, the penis 10 may be inserted into
the tubular portion 140 and at least partially into the cap 110. In
some embodiments, the penis 10 may be inserted only into the
tubular portion 140, e.g., the penis 10 is absent from the cap 110
after insertion. The securement element 150 may then be tightened
around the tubular portion 140 to secure the fluid collection
device 100 to the penis 10. Thereafter, when urine is discharged
from the penis 10, the fluid permeable layer 120 may wick the urine
away from the penis 10 towards the reservoir 122 and aperture 124,
and a vacuum may pull the urine out of the fluid collection device
100 through the conduit 108.
[0047] FIG. 2 is an isometric view of a fluid collection device 200
including a body 210 having an opening 206 and an aperture 224
opposite to the opening 206, a securement element, and a conduit
108. The body 210 may include a fluid impermeable layer, such as
any of the materials described above in relation to the cap 110.
The body 210 may define or otherwise include the chamber that is
sized and dimensioned to receive at least a portion of the head of
the penis 10. In some embodiments, chamber is sized and dimensioned
to receive the head and at least a portion of the shaft of the
penis 10. The opening 206 of the body 210 leads to the chamber and
is sized and dimensioned to receive at least a head of the penis
10. The aperture 224 is configured to receive the conduit 108,
thereby providing fluid communication between the chamber of the
body 210 and the conduit 108. In some embodiments, the body 210
includes a thin film layer. For example, the body 210 may include a
polyethylene or polyethylene film. The body also may include a
through hole 218 that may be positioned between the aperture 224
and the opening 206. The through hole 218 may be sized and
dimensioned for receiving at least a portion of a valve 252
therein.
[0048] The securement element includes one or more (e.g., two)
inflatable rings 250 secured or securable to the body 210 and
including the valve 252. The one or more inflatable rings 250 may
include inflatable silicone O-rings or any other inflatable ring.
The valve 252 may be positioned or positionable at least partially
in the through hole 218 and is configured to receive air to inflate
the one or more inflatable rings 250 and exhaust air to deflate the
one or more inflatable rings 250. In some embodiments, the valve
252 includes a fixed pressure regulator, and air pressure to the
one or more inflatable rings 250 may be regulated through the valve
252. A fixed pressure regulator allows the one or more inflatable
rings 250 to exert the same desired (low) pressure on the penis 10,
regardless of the size of the penis 10. In some embodiments, the
valve 252 may receive air from an air line at the care facility or
a standard syringe. In embodiments having two or more inflatable
rings 250, the fluid collection device 200 may include a connector
254 in fluid communication with the valve 252 and the two
inflatable rings 250 such that the two inflatable rings 250 may be
inflated through a single valve 252.
[0049] Inflation of the one or more inflatable rings 250 decreases
an inner diameter of one or more inflatable rings 250 effective to
secure the body 210 to the penis 10. Accordingly, once the penis 10
is inserted into the chamber of the body 210, the one or more
inflatable rings 250 may be inflated to complement the size of the
particular penis 10. In some embodiments, the one or more
inflatable rings 250 are secured to the body 210 within the chamber
of the body 210. In some embodiments, the one or more inflatable
rings 250 are separable from the body 210. That is, the one or more
inflatable rings 250 may be positioned on the penis before or after
the penis 10 is inserted into the chamber of the body 210. For
example, the one or more inflatable rings 250 may be positioned on
the penis 10 before inflation of the one or more inflatable rings
250 and then the penis 10 (with the one or more inflatable rings
250) may be inserted into the chamber of the body 210. Once the
penis 10 is in the chamber of the body 210, the one or more rings
250 may be inflated to the desired inflation level. When inflated
to a proper level, the one or more inflatable rings 250 may secure
the body 210 to the penis 10 and also form a seal between a distal
portion of the chamber and the opening 206, thereby preventing
urine or other discharged fluids from exiting the chamber of the
body through the opening 206. In embodiments having the one or more
inflatable rings 250 within the chamber during use, the body 210
also may define or otherwise include an inflation inlet allowing
access and/or fluid communication to the valve 252. In some
embodiments, the one or more inflatable rings 250 may be positioned
outside the chamber on an outer surface of the body 210.
[0050] Although not shown in in FIG. 2, in some embodiments, the
fluid collection device 200 includes a fluid permeable layer 120
and/or a reservoir 122 in the chamber of the body 210, as described
above in relation to the fluid collection device 100. The fluid
permeable layer may extend at least to an inflatable ring of the
one or more inflatable rings 250. The inflatable ring may be
positioned between the fluid permeable layer and the body 210, or
the fluid permeable layer may be positioned between the inflatable
ring and the fluid impermeable layer.
[0051] A fluid collection system 300 is shown in FIGS. 3A-3D,
according to an embodiment. The fluid collection system 300
includes a cup-shaped body 310 (such as a cricket box cup) and a
securement element of a garment 350 (shown in FIG. 3D). The
cup-shaped body 310 defines or otherwise includes a chamber 304
that is sized to receive at least the penis 10 therein. In some
embodiments, the cup-shaped body 310 includes a chamber 304 sized
to receive the penis 10 and the testicles of the users therein. The
cup-shaped body 310 may be advantageous to conventional male fluid
collection devices because one size may fit most sizes of male
anatomy. The cup-shaped body 310 may include a fluid impermeable
material, including any of the materials described above in
relation to the cap 110. In some embodiments, the cup-shaped body
310 includes a semi-rigid plastic material, a soft silicone
material, a closed cell foam, or combinations thereof.
[0052] The cup-shaped body 310 also includes a perimeter and an
open cell foam seal 312 on the perimeter. The open cell foam seal
312 may be configured to allow air into the chamber 304 but prevent
fluid from exiting the chamber through the open cell foam seal 312.
In some embodiments, the open cell foam seal 312 includes a
hydrophobic open cell foam seal 312. The cup-shaped body 310 also
may define or otherwise include an aperture 324 configured to
receive the conduit 108 effective to provide fluid communication
between the chamber 304 and the conduit 108.
[0053] A fluid permeable material 320 may be positioned within the
chamber 304 and configured to direct fluid discharged from the
penis to the conduit 108 for removal from the chamber 304. The
fluid permeable material 320 may include any of the fluid permeable
materials described above in relation to the fluid permeable layer
120, including a wicking material. In some embodiments, the fluid
permeable material 320 may form a coating on an interior surface of
at least a portion (e.g., all) of the cup-shaped body. In some
embodiments, a bottom portion of the fluid permeable material 320
includes a lip, and a reservoir 322 of void space is formed in the
chamber 304. The reservoir 322 may be defined at least partially by
one or more of the cup-shape body 310, the fluid permeable material
320, and/or the seal 312. The conduit 108 may be in direct fluid
communication with the reservoir 322 such that urine directed from
the fluid permeable material 320 to the reservoir 322 may be
evacuated with the conduit 108.
[0054] The securement element of the fluid collection system 300
includes a garment 350 having one or more bands configured to wrap
around the user and a support material 352 attached to the one or
more straps and configured to secure the body 310 between the
support material 352 and the user. For example, the garment 350 may
include a jock strap garment. The garment 350 may be washable and
reusable.
[0055] A fluid collection device 400 is shown in FIGS. 4A and 4B,
according to an embodiment. In the fluid collection device 400, the
body includes a tubular body 410 and the securement element
includes at least a clip 450 configured to clip around at least a
portion of the tubular body 410. The tubular body 410 includes a
chamber 404 sized to receive and interface the penis therein. In
some embodiments, the tubular body 410 includes a fluid impermeable
barrier housing a liquid or gel and the chamber 404 includes a
passage way extending through the tubular body. The fluid
impermeable barrier may include a thin film, such as a polyurethane
or a polyethylene film. The tubular body 410 may be configured to
roll onto the penis 10 as the penis 10 is inserted into the chamber
410 and interfaces a portion of the tubular body 410 within the
chamber 404 to position at least a portion of the penis 10 in the
chamber 404. In some embodiments, the tubular portion 410 includes
a tube within a tube configured to roll onto the penis. FIG. 4A
shows the tubular body 410 before the penis 10 has been inserted
into the chamber 404, and FIG. 4B shows the tubular body 410 after
the penis 10 has been inserted into the chamber 404 and the tubular
body 410 has been rolled onto the penis 10. Because the tubular
body 410 is configured to roll onto the penis 10, a portion of the
tubular body 410 initially on an outer surface of the tubular body
410 may be rolled to be an inner surface of the tubular body 410
and partially define the chamber 404 when the tubular body 410 is
rolled onto the penis 10.
[0056] In some embodiments, the tubular body 410 includes a fluid
permeable material positioned on the tubular body 410. The fluid
permeable material may include any of the fluid permeable materials
described above in reference to the fluid permeable layer 120. The
fluid permeable material may be positioned on the tubular body 410
to interface and move with the head of the penis 10 as the penis 10
is inserted into the chamber 405. Once the tubular body 410 is
secured to the penis 10 with the clip (shown in FIG. 4B), the fluid
permeable material may wick fluid away from the penis 10 towards
the conduit 108.
[0057] The clip 450 may be configured to clip or otherwise secure
around at least a portion of the tubular body 410 and stop the
tubular body 410 from rolling when the penis 10 is positioned at a
desired positioned within the chamber 404 of the tubular body 410
effective to secure the tubular body 410 to the penis 10. The fluid
collection device 400 also may include a sump 452 secured to at
least one of the clip 450 or the tubular body 410. The sump 452 is
configured to collect fluid discharged from the penis 10 when the
penis 10 is positioned within the tubular body 410 (shown in FIG.
4B). The sump 452 may include an aperture configured to receive the
conduit 108 effective and provide fluid communication between the
chamber 404 and the conduit 108. In some embodiments, the sump 452
includes a fluid impermeable layer defining the aperture. The fluid
impermeable layer may include any of the fluid impermeable
materials described above in relation to the cap 110. The sump 452
also includes a fluid permeable material 454 positioned on the
fluid impermeable layer and configured to wick fluid towards the
aperture. The fluid permeable material 454 may include any of the
fluid permeable materials described above in relation to the fluid
impermeable layer 120.
[0058] A fluid collection device 500 is shown in FIGS. 5A and 5B,
according to an embodiment. FIG. 5A shows an isometric view of the
fluid collection device 500 and FIG. 5B shows a cross-sectional
view of the fluid collection device 500 of FIG. 5A. The body of the
fluid collection device 500 includes at least a fluid impermeable
layer 510. The fluid impermeable layer 510 may include any of the
materials described above in relation to the cap 110. In some
embodiments, the fluid impermeable layer 510 includes a fluid
impermeable film, such as a polyurethane, polyethylene, polyester,
or polypropylene film. A chamber 504 may be positioned within
and/or at least partially defined by the fluid impermeable layer
510. The chamber 504 is sized and dimensioned to receive at least a
portion of the head of the penis 10. In some embodiments, the
chamber 504 is sized and dimensioned to receive the head and at
least a portion of the shaft of the penis 10. The body of the fluid
collection device 500 also includes an opening 506 that leads to
the chamber 504 and is sized and dimensioned to receive at least
the head of the penis 10. The body also includes an aperture 524
distal to the opening 506 and configured to receive the conduit 108
effective to provide fluid communication between the chamber 504
and the conduit 108. The body also may include an inflation inlet
positioned on the fluid impermeable layer 510 to provide fluid
communication with a valve 552.
[0059] In the fluid collection device 500, the one or more
securement elements include one or more inflatable bags 550
positioned within the chamber 504. The fluid collection device 500
also may include a valve 552 to receive air to inflate the one or
more inflatable bags 550 and exhaust air to deflate the one or more
inflatable bags 550. In some embodiments, the valve 552 includes a
fixed pressure regulator and air pressure to the one or more
inflatable bags 550 may be regulated through the valve 552. A fixed
pressure regulator allows the one or more inflatable bags 550 to
exert the same desired (low) pressure on the penis 10, regardless
of the size of the penis 10. In some embodiments, the valve 552 may
receive air from an air line at the care facility or a standard
syringe. In embodiments having two or more inflatable bags 550, the
two or more inflatable bags 550 may be in fluid communication with
one another such that pressure in the two or more inflatable bags
550 may be equalized around the penis 10.
[0060] Inflation of the one or more inflatable bags 550 decreases
an inner diameter of one or more inflatable bags 550 effective to
secure the body of the fluid collection device 500 to the penis 10.
Accordingly, once the penis 10 is inserted into the chamber 504,
the one or more inflatable bags 550 may be inflated to complement
the size of the particular penis 10. With the penis 10 inserted
into the chamber 504 and the one or more inflatable bags 550 at
least partially inflated, the one or more inflatable bags 550 may
interface at least one of the head or the shaft of the penis 10. In
some embodiments, the one or more inflatable bags 550 are secured
to the body of the fluid collection device 500 within the chamber
504. In some embodiments, the one or more inflatable bags 550 are
separable from the body. That is, the one or more inflatable bags
550 may be positioned on the penis before or after the penis 10 is
inserted into the chamber 504. For example, the one or more
inflatable bags 550 may be positioned on the penis 10 before
inflation of the one or more inflatable bags 550 and then the penis
10 (with the one or more inflatable bags 550) may be inserted into
the chamber 504. Once the penis 10 is in the chamber 504, the one
or more bags 550 may be inflated to the desired inflation level.
When inflated to a proper level, the one or more inflatable bags
550 may secure the body of the fluid collection device 500 to the
penis 10 and also form a seal between a distal portion of the
chamber 504 and the opening 506, thereby preventing urine or other
discharged fluids from exiting the chamber of the body through the
opening 506. In embodiments having the one or more inflatable bags
550 within the chamber 504 during use, the body of the fluid
collection device 500 also may define or otherwise include an
inflation inlet allowing access and/or fluid communication to the
valve 552.
[0061] In some embodiments, the fluid collection device 500
includes a fluid permeable layer (not shown) and a reservoir 522 in
the chamber 504, as described above in relation to the fluid
collection device 100. The fluid permeable layer may extend at
least to an inflatable bag of the one or more inflatable bags 550.
The inflatable bag may be positioned between the fluid permeable
layer and the body of the fluid collection device 500, or the fluid
permeable layer may be positioned between the inflatable bag and
the fluid impermeable layer 510.
[0062] A fluid collection device 600 is shown in FIGS. 6A and 6B,
according to an embodiment. FIG. 6A shows an isometric view of the
fluid collection device 600 and FIG. 6B shows a cross-sectional
view of the fluid collection device 600 of FIG. 6A. The body of the
fluid collection device 600 includes a tubular portion 640 and a
fluid impermeable cap 610 secured or securable to the tubular
portion 640. Unless otherwise noted, the tubular portion 640 and
the cap 610 may include any aspect of the tubular portion 140 and
the cap 110 described above in relation to the fluid collection
device 100. For example, the cap 610 may include a fluid
impermeable cap that at least partially defines or includes the
chamber 604 and an aperture 624. The tubular portion 640 also may
at least partially define the chamber 604. The aperture 624 is
configured to receive the conduit 108 effective to provide fluid
communication between the chamber 604 and the conduit 108. In some
embodiments, the tubular portion 640 includes any of the fluid
impermeable materials described herein. For example, the tubular
portion 640 may include at least one of elastomer, a silicone, a
thermoplastic elastomer, thermoplastic polyurethane, or any
combination thereof. The body of the fluid collection device 600
also may include a fluid permeable layer 620 and a reservoir 622.
The fluid permeable layer 620 and the reservoir 622 may include any
aspect of the fluid permeable layer 120 and the reservoir 122
described above in relation to the fluid collection device 100.
[0063] In some embodiments, the tubular portion 640 includes a
plurality of projections 652 extending inwardly from an inner
surface of the tubular portion 640. The plurality of projections
652 may include a plurality of retention or detent elements, tabs,
fins, or barbs. The plurality of projections 652 are sized and
positioned to interface the penis 10 as the penis 10 is inserted
into the chamber 604 and when at least a portion of the penis 10 is
positioned within the chamber 604. In some embodiments, the
plurality of projections 652 may be angled from the inner surface
of the tubular portion 640 downward towards the cap 610. This
angling of the plurality of projections 652 inhibits the fluid
collection device 600 from accidentally moving out of position on
the penis 10. To remove the fluid collection device 600 from the
penis 10, the tubular portion 640 may be pinched to separate a
portion of the plurality of projections 652 from the penis 10.
[0064] A material of the plurality of projections 652 may include
one or more of an elastomer, a silicone, a thermoplastic elastomer,
thermoplastic polyurethane, or any combination thereof. Because the
plurality of projections 652 are highly flexible, the plurality of
projections 652 may bend to create a larger opening within the
chamber 604 to accommodate the size of the penis 10. The material
of the plurality of projections 652 also may be soft, having a
shore A durometer of about 20 to about 70, about 30 to about 60,
about 20 to about 30, about 30 to about 40, about 40 to about 50,
about 50 to about 60, about 60 to about 70, less than about 70,
less than about 60, less than about 50, less than about 40, or less
than about 30.
[0065] The one or more securement elements of the fluid collection
device 600 may include an adjustable strap 650 positioned and
configured to tighten around the tubular portion 640 to secure the
body to the penis 10 when at least a portion of the penis 10 is
positioned within the chamber 604. The adjustable strap 650 may
include any aspect of the securement element 150 described above in
relation to the fluid collection device 100. In some embodiments,
the adjustable strap 650 includes an elastic adjustable strap. In
some embodiments, the adjustable strap 650 includes at least one of
a hose clamp, a hook and loop fastener material, or one or more
fasteners.
[0066] A fluid collection device 700 is shown in FIG. 7, according
to an embodiment. The body of the fluid collection device 700
includes at least a fluid impermeable layer 710. The fluid
impermeable layer 710 may include a pouch-like and/or cup-shaped
configuration defining or otherwise including a chamber 704 and an
opening 706 both sized and dimensioned to receive at least the head
of the penis 10. In some embodiments, the chamber 704 in fluid
impermeable layer is sized and dimensioned to receive at least the
head and a portion of the shaft of the penis 10. The fluid
impermeable layer 706 also may include an aperture (not visible)
distal to the opening 706. The aperture in the fluid impermeable
layer 706 is configured to receive the conduit 108 effective to
provide fluid communication between the chamber 704 and the conduit
108.
[0067] The fluid impermeable layer 710 may include any fluid
impermeable materials described herein. In some embodiments, the
fluid impermeable layer 710 may include an impermeable film, such
as a film include one or more of polyurethane, polyethylene,
polyester, polypropylene, or combinations thereof. Though not shown
in FIG. 7, some embodiments of the fluid collection device 700
include a fluid permeable layer positioned within the chamber 704
and/or a reservoir positioned in the chamber 704 adjacent to the
aperture. The fluid permeable layer may extend across the chamber
704 or be adhered to at least a portion of the inner surface of the
fluid impermeable layer 710.
[0068] The one or more securement elements of the fluid collection
device 700 may include a drawstring 750 secured to the fluid
impermeable layer 710. The drawstring 750 may be positioned
proximate to the opening 706 or between the opening 706 and the
aperture distal to the opening 706. The drawstring 750 may be
configured to tighten the fluid impermeable layer 710 around a
portion of the penis 10. For example, the drawstring 750 may be
positioned in and through one or more channels around the fluid
impermeable layer 710 such that the drawstring 750 may be tightened
and tied around at least a portion of the fluid impermeable layer
710.
[0069] A fluid collection device 800 is shown in FIG. 8, according
to an embodiment. The body of the fluid collection device 800
includes a tubular portion 840 and a fluid impermeable cap 810
secured or securable to the tubular portion 840. Unless otherwise
noted, the tubular portion 840 and the cap 810 may include any
aspect of the tubular portion 140 and the cap 110 described above
in relation to the fluid collection device 100. For example, the
cap 810 may include a fluid impermeable cap that at least partially
defines or includes a chamber and an aperture. The tubular portion
840 also may at least partially define the chamber. The aperture is
configured to receive the conduit 108 effective to provide fluid
communication between the chamber and the conduit 108. In some
embodiments, the tubular portion 840 includes any of the fluid
impermeable materials described herein. For example, the tubular
portion 840 may include at least one of elastomer, a silicone, a
thermoplastic elastomer, thermoplastic polyurethane, or any
combination thereof. In some embodiments, the tubular portion 840
includes any of the foam materials described herein, such as an
open cell hydrophobic foam. In some embodiments, the tubular
portion 840 includes a breathable fabric. Though not shown in FIG.
8, the body of the fluid collection device 800 also may include a
fluid permeable layer and a reservoir. The fluid permeable layer
and the reservoir may include any aspect of the fluid permeable
layer 120 and the reservoir 122 described above in relation to the
fluid collection device 100.
[0070] The one or more securement elements of the fluid collection
device 800 include an adjustable hook and loop fastener strap 850
positioned and configured to tighten around the tubular portion 840
to secure the body to the penis 10 when at least a portion of the
penis 10 is positioned within the chamber. The adjustable hook and
loop fastener strap 850 also may include any aspect of the
securement element 150 described above in relation to the fluid
collection device 100. In some embodiments, the adjustable hook and
loop fastener strap 850 includes an elastic adjustable hook and
loop fastener strap. The adjustable hook and loop fastener strap
850 may be secured to the tubular portion 840 or separate from the
tubular portion 840.
[0071] A fluid collection device 900 is shown in FIG. 9, according
to an embodiment. The body of the fluid collection device 900
includes a tubular portion 940 and a fluid impermeable cap 910
secured or securable to the tubular portion 940. Unless otherwise
noted, the tubular portion 940 and the cap 910 may include any
aspect of the tubular body 140 and the cap 110 described above in
relation to the fluid collection device 100. For example, the cap
910 may include a fluid impermeable cap that at least partially
defines or includes a chamber and an aperture. The tubular portion
940 also may at least partially define the chamber. The aperture is
configured to receive the conduit 108 effective to provide fluid
communication between the chamber and the conduit 108. In some
embodiments, the tubular portion 940 includes any of the fluid
impermeable materials described herein. For example, the tubular
portion 940 may include at least one of elastomer, a silicone, a
thermoplastic elastomer, thermoplastic polyurethane, or any
combination thereof. In some embodiments, the tubular portion 940
includes any of the foam materials described herein, such as an
open cell hydrophobic foam. In some embodiments, the tubular
portion 940 includes a breathable fabric. Though not shown in FIG.
9, the body of the fluid collection device 900 also may include a
fluid permeable layer and a reservoir. The fluid permeable layer
and the reservoir may include any aspect of the fluid permeable
layer 120 and the reservoir 122 described above in relation to the
fluid collection device 100.
[0072] The one or more securement elements of the fluid collection
device 900 include an adjustable ratchet strap 950 positioned and
configured to tighten around the tubular portion 940 to secure the
body to the penis 10 when at least a portion of the penis 10 is
positioned within the chamber. The adjustable ratchet strap 950
also may include any aspect of the securement element 150 described
above in relation to the fluid collection device 100. In some
embodiments, the adjustable ratchet strap 950 includes an elastic
adjustable ratchet strap. The adjustable ratchet strap 950 may be
secured to the tubular portion 940 or separate from the tubular
portion 940.
[0073] A fluid collection device 1000 is shown in FIG. 10,
according to an embodiment. The body of the fluid collection device
1000 includes a tubular portion 1040 and a fluid impermeable cap
1010 secured or securable to the tubular portion 1040. Unless
otherwise noted, the tubular portion 1040 and the cap 1010 may
include any aspect of the tubular portion 140 and the cap 110
described above in relation to the fluid collection device 100. For
example, the cap 1010 may include a fluid impermeable cap that at
least partially defines or includes a chamber and an aperture. The
tubular portion 1040 also may at least partially define the
chamber. The aperture is configured to receive the conduit 108
effective to provide fluid communication between the chamber and
the conduit 108. In some embodiments, the tubular portion 1040
includes any of the fluid impermeable materials described herein.
For example, the tubular portion 1040 may include at least one of
elastomer, a silicone, a thermoplastic elastomer, thermoplastic
polyurethane, or any combination thereof. In some embodiments, the
tubular portion 1040 includes any of the foam materials described
herein, such as an open cell hydrophobic foam. In some embodiments,
the tubular portion 1040 includes a breathable fabric. Though not
shown in FIG. 10, the body of the fluid collection device 1000 also
may include a fluid permeable layer and a reservoir. The fluid
permeable layer and the reservoir may include any aspect of the
fluid permeable layer 120 and the reservoir 122 described above in
relation to the fluid collection device 100.
[0074] The one or more securement elements of the fluid collection
device 1000 include one or more worm drive hose clamps 1050
positioned and configured to tighten around the tubular portion
1040 to secure the body to the penis 10 when at least a portion of
the penis 10 is positioned within the chamber. The one or more worm
drive hose clamps 1050 also may include any aspect of the
securement element 150 described above in relation to the fluid
collection device 100. In some embodiments, the one or more worm
drive hose clamps 1050 includes one or more elastic worm drive hose
clamps. The one or more worm drive hose clamps 1050 may be secured
to the tubular portion 1040 or separate from the tubular portion
1040.
[0075] A fluid collection device 1100 is shown in FIGS. 11A and
11B, according to an embodiment. The fluid collection device 1100
is configured to wrap around the penis 10. FIG. 11A is an unwrapped
configuration of the fluid collection device 1100, and FIG. 11B is
a wrapped configuration of the fluid collection device 1100 of FIG.
11A. The body of the fluid collection device 1100 includes a fluid
impermeable layer 1110 including a first region 1112 having an
inner surface and an outer surface, a second region 1114 having an
inner surface and an outer surface, a slot 1118 separating two
portions 1114a, 1114b of the second region 1114, and a fluid
permeable layer 1120 secured to the inner surface of the two
portions 1114a, 1114b of the second region 1114. The conduit 108 is
positioned at least partially in the slot 1118 between the two
portions 1114a, 1114b of the second region 1114. The fluid
permeable layer 1120 may include any fluid permeable materials
described above in relation to the fluid permeable layer 120. The
fluid impermeable layer 1110 may include any fluid impermeable
material described herein, including a fluid impermeable film such
as a polyurethane, polyethylene, polyester, or polypropylene
film.
[0076] The one or more securement elements of the fluid collection
device 1100 include an adhesive strip 1150 secured to the inner
surface of the first region 1112 and a different adhesive strip
1152a, 1152b secured to the inner surface of each of the two
portions 1114a, 1114b of the second region 1114 distal to the first
region 1112. The adhesive strips 1150, 1152a, 1152b may include any
adhesive known in the art, such as an adhesive used on a
diaper.
[0077] To adjust the fluid collection device from the unwrapped
configuration shown in FIG. 11A to the wrapped configuration show
in FIG. 11B, the first region 1112 of the body is configured to
wrap around at least the head of the penis 10 with the adhesive
strip 1150 of the first region 1112 positioned to secure to the
outer surface of the first region 1112, thereby defining at least a
portion of the chamber of the fluid collection device 1100. The two
portions 1114a, 1114b of the second region 1114 are configured to
fold towards the first region 1112 with the different adhesive
strip 1152a, 1152b of each of the two portions 1114a, 1114b of the
second region 1114 positioned to secure to the outer surface of the
first region 1112 to position the fluid permeable layer 1110
proximate to the head of the penis 10. In the wrapped configuration
on the penis 10, the conduit 108 extends through the slot 1118 into
the chamber. The fluid permeable layer 1120 is positioned on the
inner surface of the second region 1112 effective to direct urine
discharged from the penis 10 to the conduit 108 when the fluid
collection device 1100 is in the wrapped configuration shown in
FIG. 11B.
[0078] FIG. 12 is a flow diagram of a method 1200 for collecting
fluids, according to an embodiment. The method 1200 includes an act
1210 of positioning a head of a penis within a chamber defined by a
body of a fluid collection device. The method 1200 also includes an
act 1220 of securing the body of the fluid collection device to the
penis with one or more securement elements. The method 1200 also
includes an act 1230 of receiving fluids from the penis into the
chamber of the fluid collection device. In some embodiments, the
method 1200 includes an act of applying suction effective to
suction the fluids from the chamber via a conduit disposed
therein.
[0079] In some embodiments, the act 1210 of positioning a head of a
penis of a user within a chamber defined by a body of fluid
collection device includes inserting at least the head of the penis
in the chamber of a tubular body of the fluid collection device 400
and rolling the tubular body onto the penis. The tubular body
includes a fluid impermeable barrier housing a liquid or gel. The
act 1220 of securing the body to the penis with one or more
securement elements may then include securing a clip around the
tubular body that stops or prevents the tubular body from
rolling.
[0080] In some embodiments, the act 1210 of positioning a head of a
penis of a user within a chamber defined by a body of fluid
collection device includes inserting at least the head of the penis
through at least one inflatable ring secured to the body in the
fluid collection device 200. The act 1220 of securing the body to
the penis with one or more securement elements may then include
inflating the at least one inflatable ring to decrease an inner
diameter of the at least one inflatable ring and secure the body to
the penis.
[0081] In some embodiments, the act 1210 of positioning a head of a
penis of a user within a chamber defined by a body of fluid
collection device includes inserting at least the head of the penis
through a tubular portion including an open cell foam and into a
fluid impermeable cap secured to the tubular portion in the fluid
collection devices 100, 600, 900. The act 1220 of securing the body
to the penis with one or more securement elements may then include
securing an adjustable strap around the tubular portion to secure
the body to the penis when at least a portion of the penis is
positioned within the chamber. The method 1200 may further include
pulling the fluid in the chamber through the conduit with a vacuum
force with air to flowing into chamber through the open cell
foam.
[0082] In some embodiments, the act 1210 of positioning a head of a
penis of a user within a chamber defined by a body of fluid
collection device may include positioning the head of the penis
within a chamber defined by a cup-shaped body with an open cell
hydrophobic foam seal on a perimeter of the cup-shaped body of the
fluid collection device 300 positioned against the user. The act
1220 of securing the body to the penis with one or more securement
elements may then include positioning a support material of a jock
strap garment over the cup-shaped body within one more bands of the
jack strap garment wrapped around the user.
[0083] In some embodiments, the act 1210 of positioning a head of a
penis of a user within a chamber defined by a body of fluid
collection device may include wrapping a first region of the body
of the fluid collection device 1100 around at least the head of the
penis. The act 1220 of securing the body to the penis with one or
more securement elements includes securing an adhesive strip on the
inner surface of the first region to the outer surface of the first
region, folding two portions of a second region of the body towards
the first region and securing different adhesive strips on an inner
surface of each of the two portions of the second region to the
outer surface of the first region to position a fluid permeable
layer on the two portions of the second region proximate to the
head of the penis, the conduit extending through a slot between the
two portions and into the chamber.
[0084] In some embodiments, the act 1220 of securing the body to
the penis with one or more securement elements includes inflating
one or more inflatable bags within the chamber of the fluid
collection device 500. In some embodiments, the 1220 of securing
the body to the penis with one or more securement elements includes
tightening a drawstring secured to the body of the fluid collection
device 700 around the penis. In some embodiments, the act 1220 of
securing the body to the penis with one or more securement elements
includes securing a hook and loop material fastener strap around a
tubular portion of the body of the fluid collection device 800. In
some embodiments, the act 1220 of securing the body to the penis
with one or more securement elements includes tightening one or
more worm drive hose clamps around a tubular portion of the body of
the fluid collection device 1000.
[0085] Acts 1210, 1220, and 1230 of the method 1200 are for
illustrative purposes. For example, the acts 1210, 1220, and 1230
of the method 120 may be performed in different orders, split into
multiple acts, modified, supplemented, or combined. In an
embodiment, one or more of the acts 1210, 1220, and 1230 of the
method 120 may be omitted from the method 300. Any of the acts
1210, 1220, and 1230 of the method 120 may include using any of the
fluid collection devices or systems disclosed herein.
[0086] FIG. 13 is a block diagram of a system 11 for fluid
collection, according to an embodiment. The system 11 includes a
fluid collection device 12, a fluid storage container 14, and a
portable vacuum source 16. The fluid collection device 12 may
include any of the fluid collection devices described herein, such
as the fluid collection devices 100, 200, 300, 400, 500, 600, 700,
800, 900, 1000, 1100. The fluid collection device 12, the fluid
storage container 14, and the portable vacuum source 16 may be
fluidly coupled to each other via one or more conduits 17. The
conduit 17 may include any of the conduits described herein, such
as the conduit 118. The fluid collection device 12 may be operably
coupled to one or more of the fluid storage container 14 or the
portable vacuum source via the conduit 17. Fluid (e.g., urine or
other bodily fluids) collected in the fluid collection device 12
may be removed from the fluid collection device 12 via the conduit
17, which protrudes into an interior region of the fluid collection
device 12. For example, a first open end of the conduit 17 may
extend into the fluid collection device 12 to a reservoir therein.
The second open end of the conduit 17 may extend into the fluid
storage container 14 or the portable vacuum source 16. The suction
force may be introduced into the interior region of the fluid
collection device 12 via the first open end of the conduit 17
responsive to a suction (e.g., vacuum) force applied at the second
end of the conduit 17. The suction force may be applied to the
second open end of the conduit 17 by the portable vacuum source 16
either directly or indirectly.
[0087] The suction force may be applied indirectly via the fluid
storage container 14. For example, the second open end of the
conduit 17 may be disposed within the fluid storage container 14
and an additional conduit 17 may extend from the fluid storage
container 14 to the portable vacuum source 16. Accordingly, the
portable vacuum source 16 may apply suction to the fluid collection
device 12 via the fluid storage container 14. The suction force may
be applied directly via the fluid storage container 14. For
example, the second open end of the conduit 17 may be disposed
within the portable vacuum source 16. An additional conduit 17 may
extend from the portable vacuum source 16 to a point outside of the
fluid collection device 12, such as to the fluid storage container
14. In such examples, the portable vacuum source 16 may be disposed
between the fluid collection device 12 and the fluid storage
container 14.
[0088] The fluid collection device 12 may be shaped and sized to be
positioned on a penis. The fluid collection device 12 may include
body at least partially defining a chamber (e.g., interior region
of the fluid collection device member) of the fluid collection
device 12. The fluid collection member of the fluid collection
device 12 may include a fluid permeable body disposed within the
fluid impermeable barrier. The fluid permeable body may include a
fluid permeable membrane and fluid permeable support disposed
within the fluid permeable membrane. The conduit 17 may extend into
the fluid collection device 12 at an end region of the fluid
collection device 12. Example fluid collection devices for use with
the systems and methods herein are described in more detail
above.
[0089] In some embodiments, the fluid storage container 14 may
include a bag (e.g., drainage bag), a bottle or cup (e.g.,
collection jar), or any other enclosed container for storing bodily
fluids such as urine. In examples, the conduit 17 may extend from
the fluid collection device 12 and attach to the fluid storage
container 14 at a first point therein. An additional conduit 17 may
attach to the fluid storage container 14 at a second point thereon
and may extend and attach to the portable vacuum source 16. For
example, the fluid storage container 14 may include a container
fluidly coupled to a first conduit section that is also fluidly
coupled to the fluid collection member of the fluid collection
device 12. The container may be fluidly coupled to a second section
of the conduit 17 that is also fluidly coupled to a portable vacuum
source. In such examples, the portable vacuum source 16 may provide
a vacuum/suction through the container to the fluid collection
member to provide suction in the chamber of the fluid collection
member. Accordingly, a vacuum (e.g., suction) may be drawn through
fluid collection device 12 via the fluid storage container 14. As
the fluid is drained from the chamber, the fluid may travel through
the first section of conduit to the fluid storage container where
it may be retained. Fluid, such as urine, may be drained from the
fluid collection device 12 using the portable vacuum source 16.
[0090] In some embodiments, the portable vacuum source 16 may be
disposed in or on the fluid collection device 12. In such examples,
the conduit 17 may extend from the fluid collection device and
attach to the portable vacuum source 16 at a first point therein.
An additional conduit 17 may attach to the portable vacuum source
16 at a second point thereon and may extend out of the fluid
collection device 12, and may attach to the fluid storage container
14. Accordingly, a vacuum (e.g., suction) may be drawn through
fluid collection device 12 via the fluid storage container 14.
[0091] The portable vacuum source 16 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
portable vacuum source 16 may provide a vacuum or suction to remove
fluid from the fluid collection member of the fluid collection
device 12. In some embodiments, the portable vacuum source 16 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 examples, the portable vacuum source
16 may be sized and shaped to fit outside of, on, or within the
fluid collection device 12. For example, the portable vacuum source
16 may include one or more miniaturized pumps or one or more micro
pumps. The portable vacuum sources 16 disclosed herein may include
one or more of a switch, a button, a plug, a remote, or any other
device suitable to activate the portable vacuum source 16. It
should be understood that the portable vacuum sources 16 disclosed
herein may provide a portable means of providing a suction or
vacuum that allows use of the devices and systems herein outside of
hospital or care facility environments where vacuum lines are
plumbed into patient rooms or large (e.g., larger or heavier than a
patient can readily carry) vacuum sources are located. For example,
a portable vacuum source may be small and light enough to be
carried by a user (e.g., patient) or aid (e.g., nurse) during
transportation of the user.
[0092] As used herein, the term "about" or "substantially" refers
to an allowable variance of the term modified by "about" by .+-.10%
or .+-.5%. Further, the terms "less than," "or less," "greater
than", "more than," or "or more" include as an endpoint, the value
that is modified by the terms "less than," "or less," "greater
than," "more than," or "or more."
[0093] While various aspects and embodiments have been disclosed
herein, other aspects and embodiments are contemplated. The various
aspects and embodiment disclosed herein are for purposes of
illustration and are not intended to be limiting.
* * * * *