Note: Descriptions are shown in the official language in which they were submitted.
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SHAPED FLANGE FOR A URINE COLLECTOR
Field of the Invention
The present invention relates to a body fitting urine management device. In
particular, the present invention is directed towards urine management devices
with improved skin attachment means such that improved body fit and a tight
seal is provided between the body of the wearer and the skin, thereby
preventing leakage and contact between the feacal material and the urinary
tract and thus preventing urinary tract infections. The devices find
particular
utility for adult female wearers of such devices.
Background of the Invention
Urine management devices are known articles of manufacture that are
designed to be wom principally by incontinence sufferers and infants. Such
urine management devices are attached to the uro-genital region of the wearer
and are intended to entrap and immediately contain urine and other bodily
discharges. As a consequence, these devices are functionally effective in
lessening epidermal irritation; in preventing contamination of articles such
as
clothing and bedding; and even in preventing the soiling of the carers
themselves.
Typically, the urine management devices are made from a plastic bag
material and an adhesively faced attachment member joined to the bag. For
instance, GB 1,092,274 discloses a paediatric urine collector for female use
comprising a collector bag of plastic material opening for collection of urine
for
analysis. The base of the opening is provided with a wedge like projection
adapted to engage the lower perineal area of the infant. The collector is
secured
to the body of the wear by adhesive material. Similarly US 4 804 377 discloses
a
urine collector having a urine collection bag with a urine inlet and an
adhesively
faced attachment member. The attachment member is further provided with a
bulge shape to span the perineum of the infant wearer. The urine collection
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devices are designed to collect urine typically for analysis and thus must be
of
sufficient dimension to contain a full discharge and are therefore bulky.
Furthermore they are not designed to be worn for any length of time next to
the
body or to be worn in inside a diaper or undergarment.
There hence still exists a need to provide a urine management device
which is designed to perfectly fit and conform to the an adult wearer. In
particular there is a need to provide a urine management device for adult
wearers which provides a seal between the device and the wearer such that
leakage will not occur even when the wearer is active. Moreover it is
particularly
desirable to provide a urine management device for female adult wearers which
prevents the ingress of faecal matter or bacteria into the urinary tract, and
which
prevents the ingress of urine and bacteria from the urinary tract to the anal
region of the wearer.
Another problem related to currently available urine management devices
is the ease of placement of the device in the correct position. Adult wearers
suffering from incontinence may also be afflicted by other disabilities such
that
they require an easy means to guide the device into the correct position
required. Obviously removal and reapplication of the device is most
undesirable
particularly on the sensitive genitalia area which may be already irritated
due to
the incontinence problem and thus correct first time positioning is also
highly
desirable.
The present invention addresses these needs by providing a projection at
the rear portion of the flange. It has been found that the presence of such a
projection is uniquely advantageous and prevents the flow of urine material
out
of the rear portion of the flange and prevents the flow of faecal material
from
the anus towards the urinary tract. Furthermore, the presence of such a
projection on the urine management device causes no discomfort to the wearer,
leads to a great reduction in infections and epidermal irritations derived
from
faecal material and bacteria and results in a high level of wearer and carer
satisfaction in relation to skin healthiness. In addition the projection also
assist
in providing the wearer or caretaker with an application aid to guide the
device
into the correct position.
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In another aspect of the present invention, the urine management device
with this projection can be advantageously used with a disposable adult
incontinence diaper and or a faecal management device.
Summary of the Invention
A urine management device constructed in accordance with the present
invention comprises a bag having an aperture and a flange surrounding the
aperture for adhesive attachment to the uro-genital area of the wearer. The
anatomically-shaped flange is attached to the bag and comprises an outer
periphery, an inner periphery adjacent to the aperture, a longitudinal
centreline
and a transverse centreline wherein the transverse centreline segments the
flange into a front portion and a rear portion.
In particular, the flange comprises a projection in the rear portion. The
projection is disposed between the outer periphery and the inner periphery of
the flange in a direction parallel to the longitudinal direction. Preferably,
the
projection extends from the outer periphery to the inner periphery and is
disposed in a symmetrical manner. The projection has an effective height
ranging from 5 millimetres to 30 millimetres, preferably from 10 millimetres
to 20
millimetres, more preferably an effective height of about 12 to 20
millimetres,
moat preferably l5millimeters. The projection is particularly beneficial for
female
wearers where the projection is are adapted to fit snugly between the labia
and
the anus, i.e., the perineum of the female wearer.
In another aspect of the present invention, the present urine management
device is used in combination with a disposable adult incontinence diaper and
or with a faecal management device.
A further aspect of the invention relates to the use of said projection as an
application aid to ensure ease of placement and ideal positioning of the
device.
A yet further aspect of the invention relates to the use of said projection to
prevent leakage of the liquids entering or stored within the device.
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A further aspect of the invention relates to the use of said projection for
the
prevention of urinary tract infections.
Brief description of the drawin4s
It is believed that the invention will be better understood from the foregoing
description in conjunction with the accompanying drawings in which:
Figure 1 is a plan view of a disposable urine management device of the
present invention.
Figure 2 is a side view of the disposable urine management device of
Figure 1.
Figure 3 is a cross-sectional view taken along line 3-3 of Figure 1.
Figure 4 is a cross-sectional view of another embodiment of a disposable
urine management device of the present invention.
Detailed description of the Invention
According to Figure 1, the urine management device (10) of the present
invention comprises a bag (11 ) having an aperture and a flange {12)
surrounding the aperture (21 ) for adhesive attachment to the skin of the
wearer
in the uro genital area of the wearer.
From Figure 1, it is evident that the anatomically-shaped flange (12)
comprises an outer periphery (44), an inner periphery (45) adjacent to and
defining an aperture (13), a longitudinal centreline L and a transverse
centreline
T orthogonal thereto. The transverse centreline T segments the anatomically
shaped flange (12) into a front portion (46) and a rear portion (47). The
flange
(12) further comprises a wearer facing surface (43) and a garment facing
surface (42).
According to the present invention it has been surprisingly found that the
presence of a projection (48) positioned on the wearer facing surface of the
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anatomically shaped flange (12) as described herein after is particularly
beneficial. The projections are firstly particularly effective in reducing and
preventing any urine matter from escaping from the device (10) between the
skin and the flange and from preventing any contact of faecal matter and or
bacteria with the urinary tract and genital organs. It is believed that the
positioning of such a projection (48) at the rear portion (47) 4f the wearer
facing
surface of the flange (43) not only provides a flange which more readily
conforms to the contours of anatomy of the body, but also provides an improved
seal. In addition, a further surprising advantage of the present invention is
that
the presence of the rear projection (48) also functions as a application aid
to the
wearer or caretaker who applies the device. Using the projection the caretaker
or wearer is not only provided with an easily graspable element of the device
to
hold, but also can use the projection to guide the device into the correct
wearing
position i.e. between the labia and the anus, further improving the sealing
benefit. This is particularly useful for female wearers where the projection
may
be inserted into the urethra.
According to the present invention the projection is disposed between the
outer periphery (44) and the inner periphery (45) of the anatomically-shaped
flange (12) in a direction parallel to the longitudinal direction L. In
addition the
projection also extends in the transverse direction between the longitudinal
side
edges on either side of the longitudinal centreline t-. More preferably, the
flange
(12) extends from the outer periphery (44) to the inner periphery (45). In the
transverse direction, the projection (48) preferably does not extend across
the
entire transverse width of the flange but only up to 50°~ of the width
more
preferably up to 30°~6 of the width of the flange measured through the
centre of
the projection.
The rear projection (48) may be disposed symmetrically or asymmetrically
about the longitudinal centreline L. In a more preferred embodiment, the
projection (48) is disposed in a substantially symmetrical manner. According
to
the present invention the projection (48) extends perpendicular to the plane
of
the flange. It is important that the projection (48) be upstanding and rise
above
the plane of the flange (12) to an effective height H sufficient to present an
abrupt discontinuity to obstruct the movement of the urine or faecal material.
As
used herein, the term "effective height" refers to the maximum distance in the
Z-
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direction from the garment facing (42) of the flange (12) in its flat
orientation of
the projection, including adhesive if present on the projection surface. The
projection (48) have an effective height (h) ranging from 5 millimetres to 30
millimetres. Preferably, the projection (48) has an effective height ranging
from
millimetres to 20 millimetres, more preferably an effective height of about
12millimeters to 20 millimetres, most preferably l5millimeters. The effective
height measurements are carried out without the aid of a micrometer in order
that no pressure is exerted onto the adhesive and flange material. Typically,
the
projection (48) is orthogonal to the plane of the flange (12). It should be
recognised however that if the flange (12) has wrinkles, rugosities,
undulations
or other deviations from planarity, these should be taken into account at the
position of the projection (48), when determining its effective height. The
projection also preferably has a length (I) extending between the outer
periphery (44) of the flange to the inner periphery (45) of the flange
measured at
the longest point of from 5 millimetres to 40 millimetres, preferably from 10
millimetres to 30 millimetres, more preferably from 15millimeters to 25
millimetres , most preferably 20millimeters. The projection also has a
preferred
width (w) which is measured at the midway point of the effective height of
from 3
millimetres to 20 millimetres, preferably from 5 millimetres to 10
millimetres,
most preferably 8 millimetres.
According to the present invention the projection (48) may have any shape.
Typically the projection (48) has a longitudinal and or transverse
substantially
convex cross section. The front projection (48) is typically independently
convex
in shape and provides a hump-like or hill-like longitudinal cross section and
or
transverse cross section or provides a tubular cross section. The projection
may
also have a dual hump-like cross section, so as to provide a projection (48)
having two or more distinct heights. Preferably, the hump exhibiting the
maximum or effective height of the projection will be positioned towards the
outer periphery (44) of the flange (12).
The projection (48) is preferably hollow or partially hollow to improve
resiliency and flexibility of the projection but may also be completely
filled. For
embodiments wherein the projection (48) is hollow or partially hollow, the
projection may require additional support means in order to maintain the
desired
resilient configuration of the projection (48). Suitable support means include
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adhesives or the provision of an elastic material connecting the longitudinal
sides of the projection (48) to oneanother at (east the base of the projection
(48)
on the wearer facing surface (43) of the flange (12).
According to the present invention the projection (48) should preferably be
laterally compressible so that the projection will move inward when compressed
by lateral forces rather than spring back. The projection (48) should also be
resiliently deformable such that if for example the longitudinal sides are
compressed the upper or top portion of the projection will be forced upwards
and thereby provide a vertical extension of the projection in use and increase
the overall effective height of the device. In this manner the sealing effect
provided by the projection (48) and more preferably in combination with the
flange (12) and adhesive (20) is always maintained, even when the wearer of
the device is active during use and thereby places increased pressure onto the
device.
The projection (48) may be formed as an integral part of the flange or may
be provided as separate entities whereby a material which may be different or
identical to the flange material is attached to the flange (12) using means
known
in the art, typically adhesive. Preferably however, the projection (48) is
formed
as an integral part of the flange. The projection (48) may be made by forming
a
single pleat in the constituent material of the flange (12) or by
thermobonding
the flange material. Alternatively, the projection (48) may be provided by a
body
compatible adhesive material. In a preferred embodiment of the present
invention however, the projection (48) is formed from the flange material
itself
and utilises an adhesive support means.
The projection (48), may either be coated with adhesive or be substantially
free from adhesive. According to a preferred embodiment of the present
invention, the projection (48) is also covered with a body-compatible
adhesive.
For embodiments wherein the projection (48) comprises a dual hump
longitudinal cross section for example, it has been found particularly
beneficial
to provide only one of the surfaces of the hump, preferably the hump providing
"the effective height" with a body compatible adhesive. The remaining hump
surface may be provided with an anti slip material such as rubber.
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The term "disposable" as used herein describes devices which generally
are not intended to be laundered or otherwise restored or reused (i.e., they
are
intended to be discarded after a single use and, preferably, to be recycled,
composted or otherwise disposed of in an environmentally compatible manner}.
Referring now to figures 1 - 3, there is shown a urine management device
(10). Typically disposable urine management devices (10) comprise a bag (11 )
having an aperture (13) and a flange (12) surrounding the aperture (13) for
preferably adhesive attachment to the uro-genital area of a wearer. Any urine
management device (10) known in the art can be provided according to the
present invention.
The bag (11) as used herein is a flexible receptacle for the containment of
discharged urine matter. The bag (11 ) can be provided in any shape or size
depending on the intended use thereof, i.e. whether the device is intended for
bedridden patients or active patients suffering from incontinence or for
infants.
For example elongated bags which are principally tubular or rectangular are
typically utilised by bedridden patients and elderly incontinence sufferers.
For
more active wearers whether infants or adults, the urine management device
should preferably be anatomically shaped such that the device follows the
contours of the body and can be wom inconspicuously by the wearer under
normal garments.
Particularly, preferred shapes are flat circular and flat T shaped type bags,
cone shaped bags, truncated cone shaped bags and pyramidal or truncated
pyramidal shaped bags. In a most preferred embodiment of the present
invention, the bag (11) has a substantially flat T shape.
In addition, the bag (11 ) is preferably shaped to fit the uro-genital region
of
the wearer and ensure good contact between the flange and the skin of the
wearer. For example the bag (11 ) may be provided with a neck portion or
conduit.
The bag (11 ) is preferably designed to provide sufficient volume for urine
under a variety of wearing conditions, also when wom by a freely moving, i.e.
not bedridden wearer.
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The bag (11) is designed to safely contain any entrapped material,
typically it will be liquid impermeable, yet it may be breathable. The bag (11
) is
designed of sufficient strength to withstand rupture in use, also when
pressure
on the bag (11) is exerted.
According to the present invention, depending on the shape of the bag (11 )
required, the bag (11 ) may be provided from a unitary piece of material or
from a
number of separate pieces of material, which may be identical or different and
which are sealed at their respective peripheries.
According to the present invention the bag (11 ) can comprise one or
multiple layers, preferably two or three layers. The layer on the inside of
the
bag, which will typically at least partially come in contact with urine and or
other
bodily excretions is called the inner layer (18). The outermost layer of the
bag,
which will typically at (east partially come in contact with the skin to the
wearer
and the garments of the wearer, is called the outer layer (17).
The layers of the bag material may be provided from any material,
preferably so that the bag is liquid impervious. The layers may in particular
comprise any material such as nonwovens or films. In a preferred embodiment
of the present invention a laminate may be formed from a nonwoven layer and a
film. The laminate can be formed by means known to the man skilled in the art.
Any nonwoven layer can comprise felt fabrics, spunlaced fabrics, fluid jet
entangled fabrics, air-laid fabrics, wet-laid fabrics, dry-laid fabrics, melt-
blown
fabrics, staple fibre carding fabrics, spunbonded fabrics, stitch-bonded
fabrics,
apectured fabrics, combinations of the above or the like.
Suitable film materials for any of said layers preferably comprise a
thermoplastic material. The thermoplastic material can be selected from among
all types of hot-melt adhesives, polyolefins especially polyethylene,
polypropylene, amorphous polyolefins, and the like; material containing
meltable
components comprising fibres or polymeric binders including natural fibres
such
as cellulose - wood pulp, cotton, jute, hemp; synthetic fibres such as
fibreglass,
rayon, polyester, polyolefin, acrylic, polyamid, aramid,
polytetrafluroethylene
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metal, polyimide; binders such as bicomponent high melt/low melt polymer,
copolymer polyester, polyvinyl chloride, polyvinyl acetatelchloride copolymer,
copolymer polyamide, materials comprising blends wherein some of the
constituent materials are not meltable; air and vapour permeable materials
including microporous films such as those supplied by EXXON Chemical Co., 111,
US under the designation EXXA1RE'~ or those supplied by Mitsui Toatsu Co.,
Japan under the designation ESPOIR NOrM; and monolithic breathable materials
such as HytreIT"' available from DuPont and Pebax'''~' available from ELF
Atochem, France.
In a preferred embodiment a film, which is comprised in any layer, is
preferably permeable to gases such as air and to vapour such as water vapour
in order to avoid the problem of entrapment and condensation of moisture
vapour given off by the body of the wearer and thus, the hot, clammy and
uncomfortable conditions after a short period of use.
The outer Payer of the bag is preferably provided with a hydrophobic
fibrous nonwoven layer. Such material layers present an uneven surface to the
skin of the wearer and thus reduce significantly the problem of occlusion and
greatly improves skin healthiness.
In one preferred embodiment of the present invention the bag comprises
two layers. Preferably the outer layer (17) comprises said fibrous hydrophobic
nonwoven layer and the inner layer (18) comprises a film.
In yet another preferred embodiment of the present invention, the bag (11 )
comprises three layers, preferably one film and two nonwoven layers. In an
even more preferable embodiment the film is interposed between the two
nonwoven layers. This sequence of layers results in a closed fibrous
structure,
which has a particularly pleasing sensation on contact with the skin of the
wearer. In yet another preferred embodiment the inner layer comprises a film
and the other two layers comprise nonwovens.
Typically, the nonwoven layer is treated with a surface active material,
such as a fluorchemical or other hydrophobic finishings, to provide the
requisite
hydrophobicity. The nonwoven layer, however, may equally be treated with
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coatings of liquid impervious materials such as hot-melt adhesives or coatings
of silicone or other hydrophobic compounds such as rubbers and vegetable and
mineral waxes or it may be physically treated using nano-particufates or
plasma
coating techniques, for example.
The nonwoven layer can also be treated with agents to improve the tactile
perceivable softness of the bag. The agents include but are not limited to
vegetable, animal or synthetic oils, silicone oils and the like. The presence
of
these agents are known to impart a silky or flannel-like feel to the nonwoven
layer without rendering it greasy or oily to the tactile sense of the wearer.
Additionally, surfactant material, including anionic, non-anionic, cationic
and
non-cationic surfactants, may be added to further enhance softness and surface
smoothness.
Furthermore, the nonwoven layer may be impregnated with a lotion to
provide desirable therapeutic or protective coating lotion benefits. The
lotion is
transferable to the skin of the wearer by normal contact and wearer motion
andlor body heat. Generally, mineral oil in the form of a lotion is recognised
as
being effective in imparting a soothing, protective coating to the skin of the
wearer. It is also possible to impregnate the nonwoven layer with a solid oil
phase of cream formulation or to incorporate into the nonwoven layer an array
of
pressure- or thermal- or hydrorupturable capsules containing for example, baby
oil.
In one embodiment of the present invention the bag (11 ) may contain
absorbent material (15). The absorbent material (15) may comprise any
absorbent material which is capable of absorbing and retaining liquids. The
absorbent material may comprise a wide variety of liquid-absorbent materials
commonly used in disposable diapers and other absorbent articles such as
comminuted wood pulp, which is generally refer-ed to as airfelt. Examples of
other suitable absorbent materials include creped cellulose wadding; meltblown
polymers, including coform; chemically stiffened, modified or cross-linked
cellulosic fibers; tissue, including tissue wraps and tissue laminates;
absorbent
foams; absorbent sponges; superabsorbent polymers; absorbent gelling
materials; or any other known absorbent material or combinations of materials.
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The absorbent material (15) may be positioned in the bag (11) in any
suitable manner. For example, the absorbent material (15) may be loosely
arranged within the bag (11 ) or may be secured to the inner layer of the bag
(11 ). Any known techniques for securing absorbent material (15) to nonwoven
and film substrates may be used to secure the absorbent material to the inner
layer of the bag (11 ). The absorbent material may also be arranged to have
any
desired shape or configuration (e.g., rectangular, oval, circular, etc.).
In the embodiment shown in Figures 1-3, the outer surface of bag (11 ) is
provided with patches of adhesive (40) for securing the bag (11 ) to the body
of
the wearer. Preferably, the patches of adhesive (40) are positioned on the
outer
surface of bag (11 ) such that they are secured to the abdomen of the wearer
in
use. Any number, size and shape of adhesive patches (40) may be used
depending on the intended use of the device. The adhesive (40) may be any
medically approved water resistant pressure sensitive adhesive such as
hydrocolloid adhesives and hydrogel adhesives. Particularly effective
adhesives
in providing the desired adhesive properties to secure the flange to the skin
of
the wearer whilst allowing for relatively painless application and removal are
hydrophillic hydrogels formed from crosslinking polymers with a plastisicer to
form a 3-dimensional matrix.
Referring now to Figure 4, there is shown another embodiment of a
disposable urine management device (210). Disposable urine management
device (210) comprises a bag (211 ) having an aperture {213), a flange (212)
surrounding the aperture for adhesive attachment to the body of a wearer, and
absorbent material (215) contained within the bag (211 ).
Disposable urine management device (210) also comprises an additional
acquisition layer (270). Acquisition layer (270) is shown in Figure 6 to be
secured to the inner surface of bag (211 ). However, the acquisition layer
(270)
may also be secured to the flange (212), or both the flange (212) and the
inner
surtace of bag (211 ). Acquisition layer (270) is preferably positioned such
that it
separates the genitalia of the wearer from coming into direct contact with the
absorbent material (215). Acquisition layer (270) is fluid pervious allowing
urine
to readily pass through so that it may be absorbed by absorbent material
(215).
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The acquisition layer (270) may be manufactured from a wide range of
materials, such as porous foams; reticulated foams; apertured plastic films;
or
woven or nonwoven webs of natural fibers (e.g., wood or cotton fibers),
synthetic fibers (e.g., polyester or polypropylene fibers), or a combination
of
natural and synthetic fibers. If the acquisition, barrier layer includes
fibers, the
fibers may be spunbond, carded, wet-laid, meltblown, hydroentangled, or
otherwise processed as is known in the art.
The acquisition layer (270) is designed to have a pore size such that the
absorbent material (215) is not allowed to pass through and contact the
wearer's
skin. While designed not to have to large of a pore size which permits the
passage of absorbent material (215), the acquisition layer (270) preferably
has
a pore size which is greater than the pore size of the absorbent material
(215).
Preferably, the acquisition layer (270) is less hydrophilic than the
absorbent material (215). The acquisition layer (270) may be treated with a
surfactant to increase its initial wettability. When treated with surfactant,
however, the acquisition layer (270) should still be less hydrophilic than the
absorbent material {215). Suitable methods for treating the acquisition layer
(270) with a surfactant include spraying the acquisition layer (270) with the
surfactant and immersing the material into the surfactant. Alternatively, a
surfactant may be incorporated into the acquisition layer (270).
As shown in Figure 1 the bag (11 ) is provided with an aperture (13)
whereby urine is received from the body prior to storage within the bag
cavity.
The aperture (13) is surrounded by a flange (12} and may be provided in any
shape or size, such as circular, oblong, heart shaped and may be symmetrical
or asymmetrical, preferably the aperture has an oblong configuration either in
the longitudinal or in the transversal direction, most preferably the contours
of
the aperture are in the shape of two ellipses with the respective main axes
being
substantially perpendicular.
The flange (12) is attached to the bag (11 ) according to any means known
to the man skilled in the art which may provide permanent or releasable
attachment. Preferably however, the flange (12) is attached to the bag (11 )
by
adhesive. Typically, the bag (11) will be attached to the flange (12), towards
the
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outer periphery of flange (12) so as not to cause any obstruction for the
entering
liquids.
The flange (12) may be provided in any size depending on the wearer
group for which the device is intended. Similarly the flange (12) may be
provided
in any shape and preferably has a symmetrical shape preferably comprising a
plurality of lobes (16).
The flange comprises a garment facing portion (21 ) and a wearer facing
portion (22). In an preferred embodiment these are two large, substantially
flat
surfaces.
The flange (12) should be made of soft, flexible and malleable material to
allow easy placement of the flange to the uro genital area. In addition it is
preferred that the flange (12) be made of a hydrophobic material such that if
urine does come into contact with the perimeter (30) surrounding the aperture
(13) it is repelled and does not wick to the outer edge (32) of the flange
(12).
Typical materials include nonwoven materials, wovens, open celled
thermoplastic foams, closed-cell thermoplastic foams, composites of open
celled
foams and stretch nonwoven, and films. A closed-cell foam of polyethylene has
been found effective, but more preferably an open celled polyurethane foam is
used. Preferably, such foams have a thickness within the general range of 0.1
to
millimetres and a density of 5 to 250 g/m2, more preferably 50 g/m2. Other
thermoplastic foam materials, or other suitable plastics sheet materials
having
the described properties of such foams (i.e., softness, pliability,
stretchability,
and contractability) might also be used. Preferably, the material of garment
facing surtace (21) of the flange (12) may extend into the defined aperture
area
so as to form a skirt or flap of material which prevents unintentional
adhesion of
the surface edges of the flange (12) defining the aperture (13) to oneanother
during use.
According to the present invention the urine management device (10)
further comprises an attachment means to secure the device to the wearer.
Such means include straps and more preferably comprises a body-compatible
pressure sensitive adhesive (20) applied to the wearer facing portion (42) of
the
flange (12).
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The adhesive (20) is preferably covered with a release means (not shown)
in order to protect the adhesive (20} such as siliconized paper. The adhesive
(20) can cover the entire wearer facing surface of the flange or more
preferably
have at feast one, preferably two to six non-adhesive portions. These portions
may be adhesive free or may contain inactivated or covered adhesives. As is
evident from Figure 1, the adhesive is in one preferred embodiment not applied
to the entire wearer facing surface area of the flange (12), so as to provide
lobes (16) on either side of the flange (12) which are non-adhesive and can
thereby serve to facilitate placement and removal of the device whilst
avoiding
contact with the adhesive. These lobes are however preferably also covered by
the release means. Before application of the urine management device (10) to
the skin of the wearer, the release means if present is removed. Alternatively
a
single lobe placed centrally about the longitudinal axis of the flange (12) is
also
particularly beneficial.
According to the present invention any medically approved water resistant
pressure sensitive adhesive may be used to attach the device to the uro-
genital
area of the wearer, such as hydrocolloid adhesives and hydrogel adhesives.
Particularly effective adhesives in providing the desired adhesive properties
to
secure the flange to the skin of the wearer at the sensitive uro-genital area,
whilst allowing for relatively painless application and removal, are formed
from
crosslinking polymers with a plastisicer to form a 3-dimensional matrix.
Suitable adhesives for use herein are hydrogel adhesives available from
3M and Promeon.
The adhesive (20) can be applied to the wearer facing surface (42) of the
flange (12) by any means known in the art such as slot coating, spiral, or
bead
application or printing. Typically the adhesive (20) is applied at a basis
weight of
from 20g1m2 to 2500gIm2, more preferably from 500g1m2 to 2000g/m2 most
preferably from 700g/m2 to 1500gIm2 depending on the end use envisioned. For
example for urine management devices (10) to be used for babies the amount of
adhesive (20) may be less than for urine management devices designed for
active adult incontinence sufferers.
CA 02335701 2000-12-15
WO 00/001 I6 PCT/US99/14608
~s
According to another aspect of the present invention, the urine
management device (10) has been found particularly useful and beneficial when
utilised in conjunction with a garment or a disposable diaper andlor a faecal
management device. Typically the urine management device will be positioned
to the uro-genital area of the wearer positioned and secured to the wearer by
the adhesive flanges and patches of adhesives. Subsequently, the diaper is
positioned over the urine management device (10) and fastened in a
conventional manner around the body of the wearer. It has been found that in
addition to providing excellent separation between urine and faecal matter,
the
combined urine management device (10) and diaper system reduce skin
irritation, which may at time occur, especially as the wearer group includes
the
very old, young and unhealthy wearers.
