Note: Descriptions are shown in the official language in which they were submitted.
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BREATHABLE URINE COLLECTOR
Field of the Invention
The present invention relates to a urine management device providing
improved skin compatibility by the utilisation of a breathable bag material.
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
faecal 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
eliminating the problem of smearing on the skin of the wearer; in lessening
epidermal irritation; in preventing contamination of articles such as clothing
and
bedding; and even in preventing the soiling of the carers themselves.
Nevertheless, a problem often encountered during the use of such urine
management devices is that the constituent material of the outer surface of
the
devices tends to cause discomfort and in some cases, extreme discomfort to,
for
example, the bedridden wearer or to the infant.
Typically, the urine management devices are made from a plastic material.
For instance, GB 1,092,274 discloses a pediatric urine collector for female
use
comprising a collector bag of plastic material opening. 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. GB 2,268,882 discloses a urostomy pouch/bag of plastic material
provided with a stomal orifice which is surrounded by a first coupling member,
by which the pouch can be releasably affixed to a counterpart coupling member.
The pouch may also be provided for use as a kit further comprising an
applicator of super absorbent material which can be injected into the pouch by
the use of a plunger. EP 140 478 discloses a disposable diaper having a water
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proof barrier preferably polypropylene or polyethylene formed as a flattened
bag
having a single opening. The bag is provided with 2 layers filler materials,
the
upper layer being a wicking material and the lower being a super absorbent
material. WO 85103428 discloses a urine retaining device for male patients
comprising a protecting bag having an opening, parallelogram-walls of a water
impermeable laminate of polyethylene film and nonwoven provided with an
insert of water absorbing material.
Plastic material, while functionally acceptable, is endowed with certain
characteristics that are unsatisfactory and disagreeable to the wearer. The
feel
or texture of plastic material is particularly disturbing from the point of
view of
skin healthiness. Typically, the skin of incontinence sufferers and infants is
especially sensitive and needs to be treated gently and with care. Whilst such
devices are only releasably attached to the skin at the uro-genital region of
the
wearer, during wear the bag portion of the device will come into contact with
the
skin of the wearer. It has been recognised that the rubbing of plastic
material of
the bag of urine management devices against the body of a wearer during wear
can lead to reddening, skin rashes and perhaps, even lead to a more severe
skin irritation. Moreover another problem related to the use of such plastic
bag
materials is that skin will be occluded causing hot and clammy conditions and
skin stickiness in use. Such problems which are even further exacerbated when
the device is used in combination with a diaper, may cause such discomfort
that
the device is ultimately discarded. Therefore, a real consumer need can be
identified for a urine management device with skin compatibility benefits and
preferably providing superior cushioning qualities and a softer tactile feel.
The present invention addresses this need by providing the wall material of
the bag with a breathable material i.e. a material which is moisture vapour
permeable, allowing the skin to function normally even when in contact with
the
bag material, whilst still effectively serving its function to contain
excreted
matter. Furthermore, the urine management device is aesthetically more
pleasing, produces less crinkle during use and results in a high level of
wearer
and carer satisfaction in relation to skin healthiness.
In another aspect of the present invention, the urine management device
with its breathable bag material can be advantageously used with a disposable
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diaper. In this manner, the constituent material of the outer surtace of the
urine
management device can be capitalised upon to reduce not only the problem of
occlusion and epidermal irritations, but also contribute greatly to improved
skin
healthiness and lead to very satisfied wearers.
Summary of the Invention
A urine management device (10) constructed in accordance with the
present invention comprises a bag (11 ) having an aperture (21 ) and a flange
(12) surrounding the aperture (21 ) for adhesive attachment to the skin of the
wearer. The flange (12) is attached to the bag. The bag (11) comprises a wall
material that is selected such that it is breathable i.e. permeable to
moisture
vapour, and has a moisture vapour transport rate of at least 250
gl(m2.24hrs.).
The bag material is however more preferably permeable to both air and
moisture vapour.
According to another aspect of the present the bag material may further
comprise additional components such as odour control active agents. It has
been found that this combination of a breathable wall material with an odour
control system results in an unexpected increase in the effectiveness of the
odour control system.
In another aspect of the present invention, the urine management device is
used in combination with a disposable diaper wherein the benefits of a
breathable wall material for the bag and a breathable wall material comprising
an odour control system are particularly advantageous.
Brief description of the drawings
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.
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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 plan view of another embodiment of a disposable urine
management device of the present invention.
Figure 5 is a cross-sectional view taken along line 5-5 of Figure 4.
Figure 6 is a cross-sectional view of another embodiment of a disposable
urine management device of the present invention.
Detailed description of the invention
Referring now to figures 1 - 3, there is shown a urine management device
(10). Typically urine management devices 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.
According to the present invention, the urine management devices (10)
comprise as an essential component a breathable bag wall material. The
primary role of the wall material is to prevent the extrudes absorbed and
contained in the device from wetting clothing or the diaper that contacts the
device. In addition however, the breathable wall material permits the transfer
of
water vapour and preferably both water vapour and air through it and thus
allows the circulation of air into and out of the wall material and the device
itself.
In particular, it has been found that in older 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 that typically
occur after a short period of use of such devices; the bag material of the
devices
of the present invention are breathable.
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According to the present invention the wall material of the bag (11 ) hence
has a vapour permeability of greater than 250 g/(m2.24hrs.), preferably
greater
than 300g/m2/24hrs., more preferably greater than 500 glm2/24hrs., most
preferably greater than 600g/m2/24hrs. In a preferred embodiment of the
present invention the wall of the bag also has an air permeability of greater
than
50 I/m2/s, more preferably greater than 601/m2/s, most preferably greater than
701/m2/s.
According to the present invention any known breathable material or
multiple layer breathable material composite may be used in the device
provided that the wall material preferably meets the requirement of the liquid
permeability test as defined herein. The breathable wall materials of the
present
invention should hence have a liquid permeability at a 10 ml. load of less
than
0.16 g, preferably of less than 0.10 g, more preferably 0 g. The liquid
impervious
requirement of the wall material to liquids is of more importance for faecal
management devices which are designed to worn alone without any additional
absorbent article such as a diaper or incontinence device. However for
applications where the device is worn in combination with a diaper, the liquid
impervious ability of the wall material is not of such critical importance and
hence the liquid imperviousness of the wall material can be selected according
to the particular needs of the wearer group.
Suitable breathable wall material for use herein include all breathable wall
materials known in the art. In principle there are two types of breathable
wall
materials, single layer breathable wall materials which are breathable and
impervious to liquids and wall materials having at least two layers, which in
combination provide both breathability and liquid imperviousness.
According to the present invention the wall material of the bag hence
comprises at least 1 layer, preferably at least 2 layers and most preferably
at
least 3 layers. For embodiments wherein the bag material comprises a plurality
of layers these layers are typically bonded to one another over substantially
the
entire surface contact area. The wall material of the bag is selected such
that it
is breathable. Accordingly the breathability of the bag material may be
provided
by a single layer or by a combination of layers which together provide the
required properties of liquid impermeability and moisture vapour transport.
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According to the present invention any known breathable material layer or
multiple layer composite may be used as the bag material. Suitable bag
materials for use herein comprise at least one gas permeable layer. Suitable
gas permeable layers include 2 dimensional, planar micro and macro=porous
films, macroscopically expanded films, and monolithic films.
Suitable single layer breathable wall materials for use herein include those
described for example in GB A 2184 389, GB A 2184 390, GB A 2184 391, US 4
591 523, US 3 989 867 US 3 156 242 and European Patent Application number
95120653.1.
Suitable dual or multi layer breathable wall materials for use herein include
those exemplified in US 3 881 489, US 4 341 216, US 4 713 068, US 4 818 600,
EPO 203 821, EPO 710 471, EPO 710 472, European Patent Application
numbers 95120647.3, 95120652.3, 95120653.1 and 96830097Ø
According to the present invention the breathable wall materials comprises
at least one, preferably at least two water vapour permeable layers. Suitable
water vapour permeable layers include 2 dimensional, planar micro and macro-
porous films, monolithic films, macroscopically expanded films and formed
apertured films. According to the present invention the apertures in said
layer
may be of any configuration, but are preferably spherical or oblong. The
apertures may also be of varying dimensions. In a preferred embodiment the
apertures are preferably evenly distributed across the entire surface of the
layer,
however layers having only certain regions of the surface having apertures is
also envisioned.
2 dimensional planar films as used herein have apertures having an
average diameter of from 5 micrometers to 200 micrometers. Typically, 2-
dimensional planar micro porous films suitable for use herein have apertures
having average diameters of from 150 micrometers to 5 micrometers, preferably
from 120 micrometers to 10 micrometers, most preferably from 90 micrometers
to 7 5 micrometers. Typical 2 dimensional planar macroporous films have
apertures having average diameters of from 200 micrometers to 90 micrometers.
Macroscopically expanded films and formed apertured films suitable for use
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herein typically have apertures having diameters from 100 micrometers to 500
micrometers. Embodiments according to the present invention wherein the wall
materials comprises a macroscopically expanded film or an apertured formed
film, the wall materials will typically have an open area of more than 5 %,
preferably from 10 % to 35 % of the total wall material surface area.
Suitable 2 dimensional planar layers of the wall materials may be made of
any material known in the art, but are preferably manufactured from commonly
available polymeric materials. Suitable materials are for example GORE-TEX
(TM) or Sympatex (TM) type materials well known in the art for their
application
in so-called breathable clothing. Other suitable materials include XMP-1001 of
Minnesota Mining and Manufacturing Company, St. Paul, Minnesota, USA. As
used herein the term 2 dimensional planar layer refers to layers having a
depth
of less than 1 mm, preferably less than 0.5 mm, wherein the apertures have an
average uniform diameter along their length and which do not protrude out of
the plane of the layer. The apertured materials for use as a wall materials in
the
present invention may be produced using any of the methods known in the art
such as described in EPO 293 482 and the references therein. In addition, the
dimensions of the apertures produced by this method may be increased by
applying a force across the plane of the wall materials (i.e. stretching the
layer).
Suitable apertured formed films include films which have discrete apertures
which extend beyond the horizontal plane of the outer surface (30) of the wall
materials towards the interior of the bag thereby forming protuberances. The
protuberances have an orifice located at their terminating ends. Preferably
said
protuberances are of a funnel shape, similar to those described in US 3,
929,135. The apertures located within the plane and the orifices located at
the
terminating end of protuberance themselves maybe circular or non circular,
provided the cross sectional dimension or area of the orifice at the
termination
of the protuberance is smaller than the cross sectional dimension or area of
the
aperture located within the garment facing surface of the layer. Preferably
said
apertured preformed films are uni directional such that they have at least
substantially, if not complete one directional fluid transport towards the
interior
of the bag. Suitable macroscopically expanded films for use herein include
films
as described in for example in US 637 819 and US 4 591 523.
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Suitable macroscopically expanded films for use herein include films as
described in for example US 4 637 819 and US 4 591 523.
Suitable monolithic films include Hytrel"~, available from DuPont
Corporation, USA, and other such materials as described in Index 93 Congress,
Session 7A "Adding value to Nonwovens", J-C. Cardinal and Y. Trouilhet,
DuPont de Nemours International S.A, Switzerland.
According to the present invention the wall material may comprise in
addition to said water vapour permeable layer, additional Layers. Said
additional
layers may be located on either side of said water vapour permeable layer of
the
breathable layer. The additional layers may be of any material, such as
fibrous
layers such as wovens, nonwovens or additional water vapour permeable films.
In addition a further advantage of the breathable bag material is that the
generation of malodours associated with occlusive environments are
considerably reduced. Moreover the effectiveness of an odour control agents
within the device is further improved.
The bag (11 ) as used herein is a flexible receptacle for the containment of
excreted 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 faecal 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 type bags, flat T shaped
bags, cone shaped bags, truncated 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.
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In addition, the bag (11 ) is preferably shaped to fit the uro-genital area of
the wearer and thereby 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 worn by a freely moving, i.e.
not bedridden wearer.
The bag (11 ) is designed to safely contain any entrapped material, and is
designed of sufficient strength to withstand rupture in use, also when
pressure
on the bag is exerted in typical wearing conditions, such as sitting.
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 or
other
bodily excretions is called the inner layer (18). The outermost layer of the
bag,
which will typically at least partially come in contact with the skin to the
wearer
and the garments of the wearer, is called the outer layer (17).
The outer layer (17) of the bag is preferably provided with a non-woven
layer. Such material layers present an uneven surface to the skin of the
wearer
and thus reduce significantly the problem of occlusion and greatly improve
skin
healthiness.
In one preferred embodiment of the present invention the bag comprises
two layers. Preferably the outer layer (17) comprises a non-woven layer and
the
inner layer (18) comprises a monolithic film.
In yet another preferred embodiment of the present invention, the bag (11 )
comprises three layers, preferably one monolithic film and two non-woven
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layers. In an even more preferable embodiment the film is interposed between
the two non-woven 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
monolithic film and the other two layers comprise non-wovens.
Typically, the non-woven layer is treated with a surface active material,
such as a fluorchemical or other hydrophobic finishings, to provide the
requisite
hydrophobicity. The non-woven layer, however, may equally be treated with
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-particulates or
plasma
coating techniques, for example.
The non-woven 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 non-woven
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 non-woven layer may be impregnated with a lotion to
provide desirable therapeutic or protective coating lotion benefits. The
lotion
coating 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 non-woven layer with
a
solid oil phase of cream formulation or to incorporate into the non-woven
layer
an array of pressure- or thermal- or hydrorupturable capsules containing for
example, baby oil.
According to a particularly preferred embodiment of the present invention
the bag material may further comprise additional components such as odour
control agents. It has been found that this combination of a breathable wall
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material with an odour control system results in an unexpected increase in the
effectiveness of the odour control system. It is believed that the synergic
odour
control performance benefit of a breathable bag wall material in combination
with the presence of an odour control agent is due to a number of factors.
Firstly, the breathability of the device results in increased movement of the
volatile malodourous compounds. Hence, the amount of actual physical contact
between these compounds and the odour control agents increases. Contact
between the odour control agents and the malodourous compounds is usually
required in order to effectively combat the odourous compound. Frequently,
large quantities of the odour control system is required within the urine
management devices in order to ensure its effectiveness. This is because the
odour control agents do not necessarily contact all the malodourous compounds
present. Hence the cost of these products increases, so it is desirable to
avoid
the necessity of large quantities of the odour control system. In the present
invention, the effectiveness of the odour control agent is significantly
increased
and thus the full capacity of the odour control agent can be utilised and
hence
less may be required.
Secondly, the breathability of the urine management device wall material
reduces the hot humid and anaerobic environment between the skin of the
wearer and the surface of the device. This hinders the growth of
microorganisms, which are also known to be responsible for the generation of
odourous compounds. Thus, the amount of odours associated with the presence
of microorganisms is reduced by the urine management devices of the present
invention.
Thirdly, the reduction in the hot, humid and occlusive environment between
the vicinity of the skin of the wearer and the wearer facing surface of the
urine
management devices itself also reduces the tendency of the wearer of the
product to perspire. Consequently, the amount of associated perspiration
related odour will be reduced. Thus, the breathability of the device actually
reduces the amount of odour generated within the device. As a result the odour
control system works more effectively on the remaining odourous compounds
present in the device.
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In addition, due to the breathable nature of the device, the malodourous
compounds contained therein may, similar to water vapour and air, be more
readily exchanged with the environment. Hence, malodourous compounds are
able to escape from the device and are dissipated into the surroundings. More
importantly, the breathability of the bag wall material also allows the
precursors
compounds of malodourous compounds present in the device to escape from
the device before degradation commences and hence before malodour
formation takes place.
Any odour control agent or combinations thereof, known in the art for this
purpose may be used herein as an odour control system. The art is replete with
descriptions of various odour controlling agents for use in absorbent article
in
order to address the problem of malodour formation which may all be usefully
employed in the present invention. These agents can typically be classified
according to the type of odour the agent is intended to combat. Odours may be
chemically classified as being acidic, basic or neutral. Acidic odour
controlling
agents have a pH greater than 7 and typically include sodium carbonates,
sodium bicarbonates, sodium phosphates, particularly zinc and copper
sulphates. Basic odour controlling agents have a pH of less than 7 and include
compounds such as carboxylic acids such as citric acid, laric acid, boric
acid,
adipic acid and malefic acid.
Neutral odour controlling agents have a pH of approximately 7. Examples
of these types of compounds include activated carbons, clays, zeolites,
silicas,
absorbent gelling materials, (AGM) and starches. Neutral odour control agents
and systems are disclosed for example in EPO 348 978, EPO 510 619, WO
91!12029, WO 91111977, WO 91/12030, WO 81101643 and W096/06589. Also
cyclodextrin and derivatives thereof may be used as described in US 5429628.
Alternatively, the odour control systems may be categorised with respect to
the mechanism by which the malodor detection is reduced or prevented. The
above odour control agents typically control odour detection by an absorptive
mechanism.
Hence, odour control systems which chemically react with malodourous
compounds or with compounds which produce malodourous degradation
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products thereby generating compounds lacking odour or having an odour
acceptable to consumers may also be utilised herein. Suitable agents include
chelating agents and may be selected from amino carboxylates such as for
example ethylenediamine- tetracetate, as described for example in US 4356190,
amino phosphonates such as ethylenediaminetetrakis (methylene-
phosphonates), polyfunctionally-substituted aromatic chelating agents as
described in US 3 812 044 and mixtures thereof. Without intending to be bound
by theory it is believed that the benefit of these compounds is in part due to
their
exceptional ability to remove iron, copper, calcium, magnesium and manganese
ions present in the absorbed fluids and their degradation products by the
formation of chelates.
Another suitable odour control system for use herein comprises a buffer
system, such as citric acid and sodium bicarbonate, sodium phosphate and
sorbic acid buffer systems. Also, buffer systems having a pH of from 7 to 10
as
described for example in WO 94/25077 may be useful herein.
An alternative odour control system utilises ion exchange resins such as
those described in US 4 289 513 and US 3340875.
Masking agents or deodourants such as perfumes may also be used as
odour control agents herein. Preferably these agents are used in combination
with an additional odour control agent such as zeolite as described in
W094/22500. Also so called anti perspirants such as aluminium salts for
example aluminium chloridrate and aluminium sulphate and antimicrobics such
as Triclosan and benzoic, propionic and sorbic acids for example may also be
used as odour control agents. Such agents are described in "The Chemistry and
Manufacture of Cosmetics" Vol. 3, 2 Ed. pg. 205-208, entitled "Antiperspirants
and deodorants", by W. H. Mueller and R. P. Quatrale and 'The Journal of
Investigative Dermatology", Vol. 88, N. 3, March Suppl. 1987., entitled "Skin
Microflora", by J. J. Leydon, K. D. McGinley et al.
Other suitable odour control agents are enzyme blocking agents as
described in Cosm. and Toil. 95, 48, 1980, in " Non microbioiogical
deodourising agents" by R. Osberghaus such as triethyl cytrate and odour
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absorbers for example zinc ricinoleate as described in Cosmesi Funzionale,
pages 465-498, ED. Singerga, 1988, G. Proserpio.
The odour control system may be incorporated into the device by any of
the methods disclosed in the art. For example, the odour control agents may be
layered on the wall material or incorporated between the layers of the wall
material. Alternatively, the odour control system may be contained within
capsules or micro capsules which are activated by for example a change in
temperature, pressure or by liquid contact on wall material. The odour control
agents may be incorporated as a powder or a granulate within the device. For
odour control systems comprising more that one component the agents may be
granulated separately and then mixed together or granulated together. The
odour control material can be particularly effectively incorporated in
microporous
and monolithic films during their production or alternatively can be
sandwiched
between the layers of the bag material.
Preferred odour control agents include carbon black, zeolites, silica,
antimicrobial agents, perfuming ingredients, masking agents and chelants.
In one embodiment of the present invention the bag (11 ) may also contain
absorbent material (15). The absorbent material (15) may comprise any
absorbent material which is capable of absorbing and retaining liquids. The
absorbent material (15) 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 referred 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.
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
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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.).
As shown in Figures 1 - 3 the bag (11 ) is provided with an aperture (21 )
whereby faecal makter is received from the body prior to storage within the
bag
cavity. The aperture {21 ) 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
outer periphery of flange so as not to cause any obstruction for the entering
faecal matter.
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 (13).
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
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hydrophilic hydrogels formed from crosslinking polymers with a plastisicer to
form a 3-dimensional matrix.
Referring now to Figures 4-5, there is shown another embodiment of a
disposable urine management device (110). Disposable urine management
device (110) comprises a bag (111 ) having an aperture (113), a flange (112)
surrounding the aperture for adhesive attachment to the body of a wearer, and
absorbent material (115) contained within the bag (111 ).
The flange (112) includes a raised, curved bulge (150) positioned beneath
the aperture (113) and extending across the flange (112) for approximately the
width of the aperture (113). The bulge (150) is shaped to span the perineum of
the wearer.
Referring now to Figure 6, 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
surface 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).
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.
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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
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).
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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 glm2, 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,
stretchabiiity,
and contractability) might also be used. Preferably, the material of garment
facing surface (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 (22) of
the
flange (12).
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 least 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
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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 (22) 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 20g/mz to 2500g1m2, more preferably from 500g/m2 to 2000g/m2 most
preferably from 700g/m2 to 1500g1m2 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.
According to another aspect of the present invention, the urine
management device (10) has been found particularly useful and beneficial when
utilized in conjunction with a garment or a disposable diaper and/or 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
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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.
Test methods
Air and Vapour Permeability Test
The Vapour permeability test is utilised to quantify the vapour transmission
properties of breathable bag materials of urine management devices.
Basic Principle of the Methods
The basic principle of the test is to quantify the extent of water vapour
transmission through the wall of the bag of the urine management device. The
test method that is applied is based on a standardized textile industry
applied
test method and commonly referred to as the "cup test method". The test is
performed in a stable temperaturelhumidity laboratory maintained at a
temperature of 23° C at 50% RH for a period of 24 hours.
Apparatus
1 ) Sample cup of dimensions (open area = 0.003 m2)
2) Syringe to introduce the distilled water into the completed sample cup.
3) Wax to seal the cup once sample has been arranged.
4) A circular punch to facilitate preparation circular samples of diameter =
30
mm.
5) Laboratory of stable climatic conditions (23° C t 0.5°C / 50%
RH t 1
RH)
6) Laboratory balance accurate to 4 decimal places.
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Sample Preparation / Measurements
The test is to be performed on the wall material of the bag. A
representative device is selected and a sample is cut to size using the punch.
The sample cut is sufficiently large to adequately overlap the sample holder
and
to ensure material that may have been damaged or undesirably stretched due to
the cutting operation lies outside of the measurement centre when the
measurement is performed. The sample is so arranged onto of the sample cup
so as to fully overlap the cup. The sample is oriented so as to ensure that
the
surface exposed to the laboratory environment is the same that would be found
while wearing the article.
The closure ring of the sample cup is then placed onto the sample and
pushed down. This ensures that the excess material is held firmly in place and
does not interfere with the measurement. A wax is then applied to the entire
surface of the closure ring to ensure the whole upper part of the apparatus is
closed to the environment. Distilled water (5 t 0.25 ml) is introduced with
the
syringe into the sealed sample cup via the minute perforation. Finally this
perforation is sealed with silicone grease.
The entire cup (containing sample and water) is weighed and the weight
recorded to 4 decimal places. The cup is then placed in a ventilation stream
generated by a fan. The air flowing over the top of the sample cup is 3 t0.3
m/sec and confirmed via a wind velocity meter ("Anemo", supplied by Deuta
SpA., Italy). The sample cup remains in the ventilated test field for a period
of 24
hrs and is then re-weighted. During this period if the test sample is
sufficiently
breathable the liquid in the sample holder is able to diffuse out of the
sample
holder and into the laboratory environment. This results in a reduction in the
weight of water in the sample holder that can be quantified on re-weighing the
complete sample cup following the 24 hr period.
The vapour permeability value is determined as the weight loss divided by
the open area of the sample holder and quoted per day.
i.e. Vapour Permeability = Weight Loss (g) I (0.003 m2l 24 hrs)
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Air Permeability test
The air permeability test is utilised to assess the ability of wall material
of
the bag of urine management devices to circulation/exchange air.
Basic Principle of the Methods
The basic principle of the test is to evaluate the resistance of the wall
material to the passage of air. In this test, the volume (or amount) of air
that
flows through an article of given dimensions under standard conditions (of 23
°C
I50% RH) is measured. The instrument utilised for the test is: Air
Permeabilimeter FX 3300 manufactured by TexTest AG Switzerland.
Samples should be allowed to equilibrate in the test environment for at
least 4 hrs prior to commencement of the measurement. The article {having
dimensions exceeding 5 cm2 the dimensions of the measurement head) is
placed on the device as instructed by the manufacturer. An aspiration pump set
to generate a pressure of 1210 kPa that sucks air through the sample layer or
structure. The device measures the volume of air flow and the pressure drop
across the orifices that contains the sample and measurement head. Finally the
device generates a value of air permeability in the units of "I/M2s1 ".
Wet-Through Test
The wet-through test is utilised to evaluate the resistance of a the bag wall
material or construction to the transmission of bodily discharges. It can be
used
as a direct measure of how liquid-impervious the porous wall material is to
the
full range of bodily discharges by simply changing the composition of the test
solution as will be detailed following the method description.
Basic Principle of the Methods
The basic principle of the test is to simulate the loading of a faecal
management device in-use with bodily discharges. To achieve this a sample
device is prepared, and held on in position in a test stand clapped about the
flange such that the outer surface of the wall material of the bag of the
garment
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23
facing surface is in contact with the test stand (bottom side). Suspended
above
the sample to be analysed is a liquid delivery system that is capable of
delivering any desired quantity of the desired test liquid (either as a burst
or as
a series of steps as is desired).
Located between the garment facing surface of the bag wall material of the
test sample and the transparent test stand is a sheet of absorbent filter
paper.
This absorbent filter paper is in intimate contact with the wall material of
the test
sample to simulate, for example a when the faecal management device is in
close contact with the clothing or a diaper. Directly below the transparent
test
stand is a mirror so positioned to allow any change in the absorbent filter
paper
(wetting with coloured solutions simulating bodily discharges) to be
continuously
observed. For example if the porous bag wall material is unable to adequately
resist liquid transmission then the filter paper will become wet with the
coloured
solution and this can be observed in the mirror. The magnitude of the
transmitted solution either as a weight or more preferable the size of the
stain
on the absorbent filter paper (simulating the undergarment or diaper) in
addition
to the time dependence of the transmission can be readily recorded.
The test solution is introduced to the test sample via a calibrated delivery
system such as via a simple burette according to the desired test approach as
detailed below. Once the bag has been loaded with the test solution, a period
of
one (1 ) minute is allowed for the system to reach equilibrium.
Following the one minute wait the test sample is placed under a pressure
of 70 gsm (grams per square meter) which is believed to reflect more stressful
pressures that are nevertheless regularly obtained in-use. The test sample
remains under the 70 gsm pressure for a period of up to 30 min. and
measurements, for example the area of the coloured stain on the absorbent
paper, is measured at 5 minute intervals.
It is also important to understand the mechanism of wet-through failure and
to ensure the exact test design is able to correctly assess this. For example
a
breathable bag wall material with relatively large apertures (> 200 Nm) is
more
likely to fail due to a process of extrusion (such as when sitting the
pressure
exerted may force the liquid through the relatively large apertures) which
will
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24
happen relatively quickly on placing the test sample under pressure.
Alternatively as the apertures are made ever smaller (<200 Nm) a process of
simple diffusion or capillary driven diffusion is more likely to occur. Such
process are stow compared to extrusion processes.
This test design measures the imperviousness of the porous wall material
under a high loading (sudden stressful gush of test solution) simulation.
The high gush simulation test is performed as detailed in the above
general description under the following conditions for a faecal management
device:
Test Solution: Synthetic Urine + 1 %Surfactant
Gush Volume (ml): 10 ml
Gush Rate (ml/min.): 10 (i.e. 10 ml in 60 seconds)
Pressure applied: 70 gsm
(after 1 min. wait)
Results reported as area of stain/wet-through in units of square cm (cm2)
at time elapses of 5, 10, 20 and 30 mins.
Test solution type and volumes utilised in the test methods.
In order to reliably assess the potential bag wall materials the test solution
conditions should be matched to the product end use. These discharges can be
quite varied for different wearers and may contain various levels of fatty
acids
and detergent type contaminants from daily hygienic practices (washing,
laundering etc.). These components are extremely mobile and may have very
low surface tensions. Due to the bodily contaminants (fatty acids, surfactants
and detergent residues) found it has been determined that the addition of
surfactant to a synthetic urine solution correlates well to conditions found
in use.
The volumes again are chosen to reflect typical conditions that this
application
is likely to expose the products to. For more stressful applications the
methods
can be readily modified to simulate higher test solution loading volumes and
rates of delivery.
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Preparation of Test Solution Synthetic Urine + 1 % Surfactant (UreaB/1 %).
The test solution Synthetic Urine is first prepared in a 10 kg master batch
and smaller quantities are removed as required and surfactant is added. Each
10 Kg UreaB batch is composed of the following components:
Component: Formula Quantity110Kg batch
Urea 200 g
Sodium Chloride NaCI 90 g
Magnesium Sulphate MgS04.7H20 11 g
Calcium Chloride CaCl2 6 g
Distilled Water H20 9fi93 g
All reagents are "Reagent Grade" and available from standard Chemical
suppliers. Additionally surfactant is supplied by Pegesis, U.S.A, Peosperse
200ML. For individual measurements typically a 100 ml. test solution UreaBll
Surfactant is prepared by mixing 90 ml. Urea B solution with 10 ml.
Surfactant.
The UreaB/1 % solution must be constantly mixed to ensure the components do
not separate prior to usage.
