JP2003521267A - Breathable urine collector - Google Patents

Abstract

(57) [Summary] The present invention relates to a urine management wearing device (10) having a high degree of satisfaction. The urine management fitting (10) includes a bag (11) having an opening (13) and an anatomically shaped flange (12) surrounding the opening (13). The flange (12) provides an adhesive attachment with the wearer's genitourinary area. Specifically, the bag (11) comprises a breathable, i.e. water vapor permeable, wall material. In another aspect of the invention, a urine management fitting is used with a disposable diaper.

Description

Detailed Description of the Invention

FIELD OF THE INVENTION The present invention relates to urine management fittings that provide improved skin compatibility by utilizing breathable bag materials.

BACKGROUND OF THE INVENTION Urine control fittings are well known products designed primarily for wearing by incontinent patients and infants. Such fecal management devices are intended to be attached to the wearer's genitourinary area to capture and immediately contain urine and other body exudates. As a result, these garments eliminate the problem of soiling the wearer's skin, reducing epidermal irritation, preventing items such as clothes and bedding from becoming contaminated, and preventing the caregiver from contaminating themselves. It is functionally effective. However,
During use of such a urine management device, the constituent materials of the outer surface of the device cause discomfort, and in some cases, for example, tend to cause extreme discomfort to bedridden wearers or infants. Often face problems.

Urine management fittings are typically made of plastic materials. For example, British Patent No. 1
, 092,274 discloses a pediatric urine collector for use by a woman, which comprises an open collector bag of plastic material. The base of the opening comprises a wedge-like protrusion adapted to engage the lower perineal area of the infant. This collector is fixed to the garment body by means of an adhesive material. British Patent No. 2,268,882 discloses a urinary opening pouch / bag of a plastic material with an anastomosis orifice surrounded by a first connecting part, the first connecting part allowing the pouch to It can be removably attached to one coupling part. The pouch can also be used as a kit that further includes an applicator of superabsorbent material that can be injected into the pouch using a plunger. EP 140 47
No. 8 discloses a disposable diaper having a waterproof barrier, preferably polypropylene or polyethylene, formed as a flat bag with a single opening. The bag comprises two layers of filler material, the upper layer being the wick material and the lower layer being a highly absorbent material. WO 85/03428 discloses a urine retention fitting for a male patient, the fitting comprising an opening, a parallelogram wall of a water impermeable laminate of polyethylene film and an inlet for a water absorbent material. Including non-woven fabric.

While plastic materials are functionally acceptable, they always have the characteristic of being unsatisfactory and unpleasant for the wearer. The feel or feel of plastic materials is particularly disturbing in terms of skin health. In general, the skin of incontinence patients and infants is particularly sensitive and needs to be handled gently and carefully. Such a garment is only removably attached in the genitourinary area of the wearer, and the bag portion of the garment may contact the wearer's skin during wear. It is known that the plastic material of the urine management apparel bag may rub against the wearer's body during wear, causing redness, rashes, and even more severe skin irritation. Yet another problem associated with the use of such plastic bag materials is that the skin becomes clogged, causing a hot, sticky condition, which causes the skin to become sticky during use. The problem that this wearing tool is aggravated when used together with a diaper may cause discomfort such that the wearing tool is eventually discarded.
Therefore, a real consumer need is to find a urine management garment that has the advantage of skin compatibility, preferably with good cushioning and a softer feel.

The present invention provides a bag wall material of breathable or water vapor permeable material to allow the skin to function normally even when in contact with the bag material while containing excrement. By effectively using the function of the bag, the above demand is addressed. Further, the urine management device is more aesthetically pleasing, has less wrinkling during use, and provides a high degree of satisfaction to the wearer and caregiver regarding skin health.

In another aspect of the invention, a urine management garment comprising a breathable bag material can be advantageously used with disposable diapers. Thus, the material of construction of the outer surface of the urine management device not only alleviates the problems of occlusion and epidermal irritation, but also contributes significantly to the improvement of skin health and is very satisfying to the wearer. Can be used.

SUMMARY OF THE INVENTION A urine management fitting (10) made in accordance with the present invention comprises a bag (having a opening (21) (
11) and a bag having a flange (12) surrounding an opening (21) for adhesive attachment to the wearer's skin. The flange (12) is attached to the bag. The bag (11) is breathable, ie permeable to water vapor, and has at least 2
It includes a wall material selected to have a water vapor transport rate of 50 g / (m ² · 24 hours). However, it is more preferred that the bag material is permeable to both air and water vapor.

According to another aspect of the invention, the bag material may further comprise additional ingredients such as odor control actives. It has been found that the combination of breathable wall material and odor control system results in an unexpected increase in the effectiveness of the odor control system.

In another aspect of the invention, a urine management garment is used with a disposable diaper, but the benefits of breathable wall material for bags and breathable wall material with an odor control system are particularly advantageous.

(Detailed Description of the Invention) Next, the urine management fitting (10) will be described with reference to FIGS. Urine management fittings typically comprise a bag (11) having an opening (13) and a flange (12) surrounding the opening (13), preferably for adhesive attachment to the wearer's genitourinary area. Any urine management fitting (10) known in the art can be provided in accordance with the present invention.

In accordance with the present invention, the urine management fitting (10) includes a breathable bag wall material as an integral part. The main role of this wall material is that clothing or diapers that come into contact with the garment will
It is to prevent getting wet with excrement absorbed and contained in the wearing equipment. However, the breathable wall material allows the movement of water vapor, preferably both water vapor and air, through the wall, allowing the circulation of air into and out of the wall material and the fitting itself.

In particular, to avoid the problem of trapping and condensing water vapor emanating from the wearer's body, and thus avoiding the hot, sticky and unpleasant conditions that normally occur after short-term use of such apparel. It has been found that the bag material of the garment of the present invention is breathable.

Therefore, according to the invention, the vapor permeability of the wall material of the bag (11) is 250 g.
/ (M ² · 24 hr) greater than, preferably greater than 300g / m ^2/24 hours, more preferably greater than 500g / m ^2/24 hours, 600 g /
larger than m ^2/24 hours being most preferred. In a preferred embodiment of the invention, the air permeability of the wall of the bag is preferably greater than 50 l / m ² / s, 60 l
/ M, more preferably greater than ² / s, greater than 70l / m ² / s are most preferred.

According to the present invention, any known breathable material or multilayer breathable material mixture can be used in the present fitting, provided that the wall material has a liquid permeability test as defined herein. It is preferable to meet the requirements of. Therefore, the breathable wall material of the present invention should have a liquid permeability under a load of 10 ml of less than 0.16 g, preferably less than 0.10 g, more preferably 0 g. The liquid impermeability requirements of wall materials for liquids are more important in the case of fecal management wear designed to be worn alone without additional absorbent articles such as diapers or incontinence wear.
However, the liquid impermeability of the wall material is not so important in the case of an application example in which the wearing apparatus is worn in combination with a diaper. Therefore, it can be selected.

Breathable wall materials suitable for use herein include all breathable wall materials known in the art. There are mainly two types of breathable wall materials, a single layer breathable wall material that is breathable and impermeable to liquids, and at least two layers that combine to provide breathable and liquid impermeable materials. A wall material that provides permeability.

Therefore, according to the invention, the wall material of the bag comprises at least one layer, preferably at least two layers, most preferably at least three layers. In embodiments where the bag material comprises multiple layers, these layers are typically adhered to the other layers over substantially the entire contact surface area. The bag wall material is selected to be breathable. Thus, the breathability of the bag material can be obtained by a single layer or by a combination of layers that together provide the necessary properties of liquid impermeability and water vapor transport.

According to the invention, any known breathable material layer or multilayer mixture can be used as bag material. Suitable bag materials for use herein include at least one gas permeable layer. Gas permeable layers suitable for use herein include two-dimensional, planar microporous and macroporous films, macroscopic foamed films, and monolithic films.

Suitable single layer breathable wall materials for use herein include, for example, British Patent No. A
2184 389, British patent A2184 390, British patent A2184
391, U.S. Pat. No. 4,591,523, U.S. Pat. No. 3,989,867.
No. 3,156,242 and European Patent Application No. 95120653.
The materials described in No. 1 are included.

Suitable double or multilayer breathable wall materials for use herein include, for example:
U.S. Pat. No. 3,881,489, U.S. Pat. No. 4,341,216, U.S. Pat. No. 4,713,068, U.S. Pat. No. 4,818,600, EPO 203.
821, EPO 710 471, EPO 710 472, European Patent Application No. 9
Included are the materials described in 5120647.3, 95120652.3, 95120653.1 and 96383097.0.

According to the invention, the breathable wall material is at least one, preferably at least two.
Includes two water vapor permeable layers. Suitable water vapor permeable layers include two-dimensional, planar microporous and macroporous films, monolithic films, macrofoam films, and molded aperture films. According to the invention, the openings in the layer may have any configuration, but are preferably spherical or oblong. The openings may be of various sizes. In a preferred embodiment, it is preferred that the openings are evenly distributed over the entire surface of the layer, although layers having only certain areas of the surface with openings are also contemplated.

The two-dimensional flat film used in the present specification has an average diameter of 5 μm to 2 μm.
It has an opening of 00 micrometers. Generally, the two-dimensional planar microporous film suitable for use herein has an average diameter of the openings of usually 150 micrometers to 5 micrometers, preferably 120 micrometers to 10 micrometers, preferably 90 micrometers. Most preferred is between 15 and 15 micrometers. The average diameter of the openings in the two-dimensional flat macroporous film is usually 200 micrometers to 90 micrometers. Macroporous foam films suitable for use herein, and apertures in molded aperture films, typically have diameters of 100 micrometers to 500 micrometers. In the case of the embodiment according to the invention in which the wall material comprises a macroscopic foamed film or an aperture-formed film, the wall material typically has an open area of 5% or more of the total wall material surface area and an open area of 10% to 35%. The area is preferable.

Suitable two-dimensional planar layers of wall material can be made of any material known in the art, but are preferably made of generally commercially available polymeric materials. Suitable materials are, for example, GORE-TEX ™ or Sympatex ™, which are well known in the art for so-called breathable garments. Other suitable materials include Minnesota Mining and
Manufacturing Company, St Paul, Minne
XMP-1001 from sota, USA is included. As used herein, 2
The term dimensional planar layer has a depth of less than 1 mm, preferably less than 0.5 mm, the openings have an average constant diameter along their length, but project out of the plane of the layer. Refers to a layer that does not exist. The aperture material used as the wall material in the present invention is EP
O 293 482 and any one of the methods known in the art as described in the references herein. Furthermore, the size of the openings produced by this method can be increased by applying a force (ie stretching the layer) along the plane of the membrane material.

Suitable aperture forming films include films having discontinuous openings that extend beyond the horizontal surface of the exterior surface (30) of the wall material and into the interior of the bag, thereby forming protrusions. The protrusion has an orifice located at its end. The protrusions are preferably funnel-shaped like the protrusions described in US Pat. No. 3,929,135. The openings located in the plane and the orifices at the ends of the protrusions themselves may or may not be circular, provided that the cross-sectional dimension or area of the orifices at the ends of the protrusions is such that the garment facing surface of the layer. It must be smaller than the cross-sectional dimension or area of the opening located therein. The aperture molding film,
It is preferably unidirectional, and if not perfect, at least substantially unidirectional fluid transport towards the interior of the bag. Macroscopic foamed films suitable for use herein include, for example, the films described in US Pat. No. 6,378,819 and US Pat. No. 4,591,523.

Macroscopic foam films suitable for use herein include, for example, US Pat.
Includes films described in 637 819 and U.S. Pat. No. 4,591,523.

Suitable monolithic films include DuPont Corporation,
Hytrel ™, commercially available from USA, and Index 93 C
ongress, Session 7A, "Adding value to
Nonwovens ", JC. Cardinal and Y. Trouilhe
DuPont de Nemours International S.t.
A. , Other materials, such as those described in Swissland, Switzerland.

According to the invention, the wall material can comprise additional layers in addition to the water vapor permeable layer described above. The additional layer may be located on either side of the water vapor permeable layer of the breathable layer. The additional layer may be any material such as a fibrous layer such as a woven or non-woven fabric, or an additional water vapor permeable film.

In addition, another advantage of breathable bag materials is that the development of malodors associated with occluded environments is significantly reduced. Moreover, the effectiveness of the odor control agent in the garment is further improved.

The bag (11) used in the present specification is a flexible container for containing excreted substances. The bag (11) is provided in any shape or size depending on its intended use, ie whether the garment is for a bedridden patient, an active patient suffering from incontinence or an infant. be able to. For example, predominantly tubular or rectangular elongated bags are commonly utilized by bedridden and elderly incontinent patients. For more active wearers, be it infants or adults, fecal management fittings should be worn so that the fitting fits the contours of the body and is unobtrusive to the wearer under everyday wear. It is preferable to make it into a shape.

Specifically, the preferred shapes are flat circular type bags, flat T-shaped bags, conical bags, truncated bags and quadrangular pyramids or truncated quadrangular pyramid bags. In the most preferred embodiment of the invention, the bag (11) has a substantially flat T shape.

Furthermore, the bag (11) is preferably shaped to fit the genitourinary area of the wearer, thereby ensuring good contact between the flange and the skin of the wearer. For example, the bag (11) may include a necked portion or conduit.

The bag (11) is preferably designed to provide a sufficient volume of urine under a variety of wearing conditions and even when it is free to move around, ie worn by a non bedridden wearer. .

The bag (11) is designed to safely contain any entrapment material and to be strong enough to withstand rupture during use even when the bag is under normal wear conditions such as sitting down.

According to the invention, the bag (11) is made of a single material or a number of individual materials, which may be the same or different, depending on the shape of the bag (11) required. The perimeter is sealed.

According to the invention, the bag (11) can comprise one or more layers, preferably two or three layers. The layer on the inside of the bag, which will normally come into contact with at least part of it with urine or other body exudates, is referred to as the inner layer (18). The outermost layer of the bag, which will normally come into contact at least in part with the wearer's skin and the wearer's clothing, is referred to as the outer layer (17).

The outer layer (17) of the bag preferably comprises a nonwoven layer. Such a material layer significantly reduces the problem of occlusion and significantly improves the health of the skin by directing the uneven surface against the skin of the wearer.

In a preferred embodiment of the invention the bag comprises two layers. The outer layer (17) preferably comprises a nonwoven layer and the inner layer (18) preferably comprises a monolithic film.

In another preferred embodiment of the invention, the bag (11) comprises three layers, preferably one monolithic film and two nonwoven layers. In a more preferred embodiment, the film is inserted between two nonwoven layers. This layer arrangement results in a closed fibrous structure, which provides a particularly pleasant sensation on contact with the skin of the wearer. In another preferred embodiment, the inner layer comprises a monolithic film and the other two layers comprise a nonwoven.

Typically, the non-woven layer is treated with a surface-active material such as a fluorochemical or other hydrophobic finish to provide sufficient hydrophobicity. However, the nonwoven layer is similarly treated with a coating of a liquid impermeable material such as a hot melt adhesive or a coating of silicone or rubber and other hydrophobic compounds such as vegetable wax and mineral wax, or For example, it can be physically treated using nanoparticles or plasma coating techniques.

The nonwoven layer can also be treated with a chemical to improve the soft feel of the bag. Drugs include, but are not limited to, vegetable oils, animal or synthetic oils, silicone oils and the like. It is known that the presence of these chemicals imparts a silky or flannel-like feel to the nonwoven layer without making the wearer feel fat-like or oily. In addition, surface-active materials including anionic, non-anionic, cationic and non-cationic surfactants can be added to further increase softness and surface smoothness.

Further, the nonwoven layer can be impregnated with lotion to provide the desired therapeutic or prophylactic coating lotion benefits. Lotion coating
It is transferable to the wearer's skin through normal contact and wearer motion and / or body heat. It is generally known that mineral oils in the form of lotions are effective in providing a protective coating that relieves pain on the skin of the wearer. It is also possible to impregnate the non-woven layer with a solid oil layer of the cream formulation or to incorporate a number of pressure or heat or water destructible capsules, for example containing baby oil, into the non-woven layer.

According to a particularly preferred embodiment of the invention, the bag material may further comprise additional ingredients such as odor control agents. It has been found that the use of breathable wall materials in combination with an odor control system results in an unexpected increase in the effectiveness of the odor control system. The synergistic odor control performance benefit of breathable bag wall materials in combination with the presence of odor control agents is believed to be due to a number of factors.

First, the breathability of the garment enhances the migration of volatile malodorous compounds. Therefore,
The actual amount of physical contact between these compounds and the odor control agent is increased. Contact between the odor control agent and the malodorous compound is usually required to effectively address the odorous compound. A large amount of odor control system is often required in the urine management fitting to ensure this effectiveness. This is because the odor control agent does not necessarily contact all the malodorous compounds present. Therefore, it is desirable to avoid the need for large volumes of odor control systems as this increases the cost of these products. In the present invention, the effectiveness of the odor control agent is significantly increased and the full capacity of the odor control agent is utilized thereby reducing the required amount.

Second, the breathability of the urine management wear wall material reduces the hot, moist anaerobic environment between the wearer's skin and the surface of the wear. This hinders the growth of microorganisms, which are also known to be responsible for the generation of odorous compounds. Therefore, the amount of odor associated with the presence of microorganisms is reduced by the urine management device of the present invention.

Third, the reduction of the hot, moist, closed environment between the wearer's skin and the wearer-facing surface of the urine management device itself also tends to cause the wearer to sweat with the product. Reduce. As a result, the amount of odor associated with sweating should be reduced. Thus, the breathability of the fitment actually reduces the amount of odor generated within the fitment. As a result, the odor control system works more effectively with the remaining odorous compounds present in the garment.

Furthermore, due to the breathability of the wearing device, the malodorous compounds contained in the wearing device can be more easily exchanged with the environment like water vapor and air. In this way, the malodorous compound can escape from the garment and dissipate to the surroundings. More importantly, the breathability of the bag wall material also allows precursor compounds of malodorous compounds present in the device to escape from the device before decomposition begins and malodor formation occurs. .

For this purpose, any of the odor control agents or combinations thereof known in the art can be used herein as an odor control system. For the art, it will be sufficient to describe various odor control agents for use in absorbent articles to address the problem of malodor production usefully used in the present invention. These chemicals can usually be classified according to the type of odor they are intended to address. Odors can be chemically classified as acidic, basic or neutral. Acidic odor control agents have a pH above 7 and usually include sodium carbonate, sodium bicarbonate, sodium phosphate, especially zinc sulphate and copper sulphate. Basic odor control agents have a pH of less than 7, including citric acid, lar
Included are such compounds as carboxylic acids such as ic acid, boric acid, adipic acid and maleic acid.

The neutral odor control agent has a pH of about 7. Examples of these types of compounds include activated carbon, clays, zeolites, silicas, absorbent gelling materials, (AGM) and starch. Neutral odor control agents and systems are described, for example, in EPO 348 97.
8, EPO 510 619, WO 91/12029, WO 91/1197.
7, WO 91/12030, WO 81/01643 and WO 96/06
589. Cyclodextrins and their derivatives can also be used as described in US Pat. No. 5,492,628.

Alternatively, the odor control system can be categorized for mechanisms that reduce or prevent malodor detection. The odor control agents described above typically regulate odor detection by an absorption mechanism.

Thus, odor control systems that produce compounds that are odorless or have a consumer-acceptable odor by chemically reacting with a malodorous compound or a compound that produces a malodorous degradation product are also described herein. Can be used in writing. Suitable chemicals include chelating agents, for example aminocarboxylic acid salts such as ethylenediaminetetraacetic acid as described in US Pat. No. 4,356,190, aminophosphonate salts such as ethylenediaminetetrakis (methylenephosphonate), US Pat. No. 3,812. 044
Can be selected from the polyfunctional substituted aromatic chelating agents described in US Pat. Without intending to be bound by theory, the advantages of these compounds are, in part, the exceptional removal of iron, copper, calcium, magnesium and manganese ions present in the absorbed fluid and its degradation products by chelation. Probably due to excellent ability.

Other odor control systems suitable for use herein include buffer systems such as citric acid and sodium bicarbonate, sodium phosphate and sorbate buffer systems. Also useful herein are buffering systems having pH 7 to 10 as described in WO 94/25077, for example.

An alternative odor control system utilizes ion exchange resins such as those described in US Pat. No. 4,289,513 and US Pat. No. 3,340,875.

Masking agents, or deodorants such as perfumes, can also be used as odor control agents herein. These agents are preferably used in combination with additional odor control agents such as zeolites as described in WO94 / 22500. So-called antiperspirants such as aluminum salts, for example aluminum chloride hydrate and aluminum sulphate, and also antibacterial agents such as triclosan and benzoic acid, propionic acid and sorbic acid, are used as odor control agents. can do. Such agents are described in W. H. Mueller and R.M. P. "The Chemistry and Manufacture of C" entitled "Antiperspirants and deodorants" by Quatrale.
Osmetics ", Volume 3, Second Edition, pages 205-208 and J. Am. J. L
eydon, K .; D. "Skin Microflo" by McGinley et al.
"The Journal of Investigative" entitled "ra"
Dermatology ", Vol. 88, No. 3, March Supplement, 1987.

Other suitable odor control agents are triethyl citrate.
trade) and other Cosm. and Toil. , Vol. 95, p. 48, 19
R.M. "Non microbiolog" by Osberghaus
enzymatic deodorizing agents "and Cosmesi Fusionale, pp. 465-498, ED. Singerga, 1988, G. It is an odor absorber such as zinc ricinoleate described in Proserpio.

The odor control system can be incorporated into the garment by any of the methods disclosed in the art. For example, the odor control agent can be layered on the wall material or incorporated between layers of the wall material. Alternatively, the odor control system can be encapsulated in microcapsules, eg activated by changes in temperature, pressure or contact with liquids on the wall material. The odor control agent can be incorporated into the garment as a powder or granules. In the case of odor control systems containing multiple components, the agents can be granulated separately and then mixed or granulated together. The odor control material is particularly effective when incorporated into microporous and monolithic films during manufacture or sandwiched between layers of bag material.

Preferred odor control agents include carbon black, zeolite, silica, antibacterial agents,
Aroma components, masking agents and chelants are included.

In one embodiment of the invention, the bag (11) may include an absorbent material (15). The absorbent material (15) includes any absorbent material capable of absorbing and retaining liquid. The absorbent material (15) is generally made of air felt.
It includes a wide variety of liquid absorbent materials that are widely used in disposable diapers and other absorbent products, such as ground wood pulp, referred to as t). Examples of other suitable absorbent materials include crumpled cellulose fillings, meltblown polymers including coforms, chemically cured, modified or crosslinked cellulosic fibers, tissue wraps and tissue laminates. Included tissue, absorbent foam, absorbent sponge, superabsorbent polymer, absorbent gel material, or other known absorbent material or combination of materials.

The absorbent material (15) can be placed in the bag (11) by any suitable method. For example, the absorbent material (15) may be loosely placed in the bag (11) or fixed to the inner layer of the bag (11). Absorbent materials (1
The absorbent material can be secured to the inner layer (11) of the bag using any known technique for securing 5). The absorbent material can also be arranged in any desired shape or configuration (eg, rectangular, oval, circular, etc.).

As shown in FIGS. 1-3, the bag (11) is provided with an opening (21) through which fecal material is received from the body and stored in the cavity of the bag. The opening (21) is surrounded by a flange (12) and can be of any shape or size, such as circular, oblong, heart-shaped, etc., which can be symmetrical or asymmetrical, but the opening is longitudinal or It is preferred to have an oblong configuration in either transverse direction, most preferably the contour of the opening is in the form of two ellipses with their respective major axes substantially perpendicular.

The flange (12) is attached to the bag (11) according to any method known to those skilled in the art that allows for permanent or removable attachment. However, the flange (12) is preferably attached to the bag (11) with an adhesive. Normally, the bag (1
1) must be attached to the flange (12).

The flange (12) may be of any size, depending on the wearer group for each purpose of wearing the garment. Similarly, the flange (12) may have any shape, but is preferably symmetrical with a plurality of lobes (13).

In the embodiment shown in FIGS. 1-3, the outer surface of the bag (11) is attached to the body of the wearer (
11) is provided with a patch of adhesive (40) for fixing. The adhesive patch (40) is preferably located on the outer surface of the bag (11) so that it is secured to the wearer's abdomen during use. Any number, size and shape of adhesive patches (40) may be used depending on the intended use of the garment. Adhesive (40) may be any of the medically acceptable water resistant pressure sensitive adhesives, such as hydrocolloid adhesives and hydrogel adhesives. A particularly effective adhesive that provides the desired adhesion for securing the flange to the wearer's skin and allows for relatively painless application and removal is a three-dimensional matrix formed by the cross-linking of a polymer and a plasticizer. Is a hydrophilic hydrogel.

Next, another embodiment of the disposable urine management fitting (110) will be described with reference to FIGS. The disposable urine management fitting (110) includes a bag (111) having an opening (113), a flange () surrounding the opening for adhesive attachment to the wearer's body.
112) and an absorbent material (115) contained within a bag (111).

The flange (112) is arranged below the opening (113) and has an opening (113).
There is a raised bulge (150) that is as wide as and extends beyond the flange (112). The bulge (150) is shaped so that it extends across the wearer's perineum.

Next, another embodiment of the disposable urine management attachment (210) will be described with reference to FIG. The disposable urine management device (210) has a bag (21) having an opening (213).
1), a flange (212) surrounding the opening for adhesive attachment to the wearer's body.
) And an absorbent material (215) contained within a bag (211).

The disposable urine management fitting (210) also includes an additional acquisition layer (270). The acquisition layer (270) fixed to the inner surface of the bag (211) is shown in FIG. However, the acquisition layer (270) may also be a flange (212), or a flange (212).
And the inner surface of the bag (211) can also be fixed. The acquisition layer (270) is preferably positioned so that the wearer's genitals do not come into direct contact with the absorbent material (215). The acquisition layer (270) is fluid permeable to allow easy passage of urine, so that urine can be absorbed by the absorbent material (215).

The acquisition layer (270) may be a porous foam, a reticulated foam, an aperture plastic film, or a natural fiber (eg wood fiber or cotton fiber), a synthetic fiber (eg
It can be made from a wide range of materials such as woven or non-woven fabrics (polyester or polypropylene fibers) or combinations of natural and synthetic fibers. capture,
If the barrier layer comprises fibers, the fibers may be spunbonded,
It can be fluffed, wet-laid, melt blown, hydroentangled or otherwise processed as known in the art.

The acquisition layer (270) is designed to have a pore size such that the absorbent material (215) does not pass through and contact the skin of the wearer. The trapping layer (270), even if it is designed so as not to have a large pore size that allows passage of the absorbent material (215).
Preferably has a pore size larger than the pore size of the absorbent material (215).

The capture layer (270) is preferably less hydrophilic than the absorbent material (215). The acquisition layer (270) can be treated with a surfactant to increase its initial wettability. However, even when treated with a surfactant, the acquisition layer (270) must still be less hydrophilic than the absorbent material (215). Acquisition layer (270
Suitable methods of treating) with a surfactant include spraying the capture layer (270) with the surfactant and immersing the material in the surfactant. Alternatively, a surfactant can be incorporated into the acquisition layer (270).

As shown in FIG. 1, the bag (11) comprises an opening (13) through which urine is received from the body and stored in the void of the bag. The opening (13) is a flange (
12) and may be of any shape or size, such as circular, oblong, heart-shaped, etc. and may be symmetrical or asymmetrical, but with openings that are long either longitudinally or transversely. It is preferred to have an elliptical structure, most preferably the contour of the opening is in the form of two ellipses with their respective major axes substantially perpendicular.

The flange (12) is attached to the bag (11) according to any method known to those skilled in the art that allows for permanent or removable attachment.
However, the flange (12) is preferably attached to the bag (11) with an adhesive. Normally, the bladder (11) must be attached to the flange (12) towards the outer edge of the flange (12) so as not to prevent liquid entry.

The flange (12) may be of any size, depending on the group of wearers for each purpose of wearing the garment. Similarly, the flange (12) may have any shape, but is preferably symmetrical with a plurality of lobes (13).

The flange includes a garment facing portion (21) and a wearer facing portion (22). In the preferred embodiment, these are two large, substantially flat surfaces.

The flange (12) must be made of a soft, flexible and malleable material so that the flange can be easily placed in the genitourinary area. Furthermore, even if the urine contacts the boundary line (30) surrounding the opening (13), the urine is repelled and the flange (
The flange (12) is preferably made of a hydrophobic material so that it does not escape to the outer edge (32) of 12). Typical materials include non-woven materials, woven fabrics, open cells (
open celled thermoplastic foam, closed-ce
11) Includes thermoplastic foams, composites of open cell foams and stretchable nonwovens, and films. While closed cell foams of polyethylene have been found to be effective, it is more preferred to use open cell polyurethane foams. Such foams have a thickness of 0.1 to 5 millimeters and a thickness of 5 to 250 g / m ^2.
The density is preferably 50 g / m ² and more preferably 50 g / m ² . Other thermoplastic foam materials or other suitable plastic sheet materials having the aforementioned foam properties (ie, softness, flexibility, stretchability, and contractability) may also be used. The garment-facing surface (21) material of (12) may be a skirt or a material of material that prevents the surface edges of the flange (12) that separates the opening (13) and other portions from unintentionally adhering during use. It preferably extends into the defined open area so as to form a flap.

According to the invention, the urine management fitting (10) further comprises attachment means for fixing the fitting to the wearer. Such means include a strap, but more preferably a biocompatible pressure sensitive adhesive (20) applied to the wearer facing portion (22) of the flange (12).

In order to protect the adhesive agent (20), it is preferable that the adhesive agent (20) is covered with a releasing means (not shown) such as paper treated with silicone. The adhesive (20) may cover the entire wearer facing portion of the flange, but preferably has at least one non-stick portion, preferably two to six. These portions may include an adhesive or passivated or covered adhesive. As is apparent from FIG. 1, in a preferred embodiment, no adhesive is applied to the entire surface of the flange facing the wearer, and non-stick lobes (1) on either side of the flange (12).
6), which can help facilitate installation and removal of the garment while avoiding contact with the adhesive. However, these lobes are also preferably covered by the release means. Prior to attaching the urine management fitting (10) to the skin of the wearer, the release means, if any, is removed. Alternatively, a single lobe located approximately in the center of the longitudinal axis of the flange (12) is also particularly useful.

According to the present invention, any of the medically acceptable water resistant pressure sensitive adhesives, such as hydrocolloid adhesives and hydrogel adhesives, is used to attach the garment to the wearer's genitourinary area. can do. A particularly effective adhesive that provides the desired tackiness and is relatively painless to apply and remove to secure the flange to the wearer's skin in the sensitive genitourinary area, because it forms a three-dimensional matrix. It is formed by cross-linking the polymer and the plasticizer.

Adhesives suitable for use herein are hydrogel adhesives commercially available from 3M and Promeon.

The adhesive (20) may be slot coated, spiral coated, or beaded (
It may be applied to the wearer facing surface (22) of the flange (12) by any means known in the art such as bead application or baking. Adhesive (20) is typically 20 g / m ² on a mass basis depending on the intended end use.
To 2500 g / m ² , with 500 g / m ² to 2000 g / m ² being more preferred, and 700 g / m ² to 1500 g / m ² being most preferred. For example, in the case of a urine management fitment (10) used for infants, the amount of adhesive (20) is less than in a urine management fitment designed for active adult incontinence patients.

According to another embodiment of the present invention, the urine management fitting (10) has been found to be particularly useful and beneficial when utilized in conjunction with clothing or disposable diapers and / or fecal management fittings. It was Typically, the urine management garment will be placed in the genitourinary area of the wearer and secured to the wearer with an adhesive flange and a patch of adhesive. As a result, the diaper is placed over the urine management garment (10) and secured around the wearer's body in the conventional manner. Besides obtaining an excellent separation between urine and fecal material,
It has been found that the combined urine management garment (10) and diaper system reduces skin irritation, at the same time especially when the wearer group includes the elderly, adolescents and unhealthy wearers.

(Test Method) Air and Vapor Permeation Test The vapor permeation test is utilized to quantify the vapor permeation characteristics of the breathable bag material of the urine management fitting.

Basic Principles of the Method The basic principle of the test is to quantify the extent of water vapor permeation through the wall of the bag of the urine management fitting. The test method used is a standardized test method applied to the textile industry and is generally called the "cup test method". This test is conducted at a temperature of 23 ° C and 50% RH.
Stable temperature / humidity maintained at room temperature for 24 hours.

Device 1) Sample cup of size (opening area = 0.003 m ² ) 2) Syringe for introducing distilled water into the prepared sample cup 3) Wax for placing the sample and sealing the cup 4) Circular punch for facilitating the preparation of circular samples with a diameter of 30 mm 5) Laboratory with stable climatic conditions (23 ° C ± 0.5 ° C / 50% RH ± 1% RH) 6) 4th decimal place Accurate laboratory tempin

Sample Preparation / Measurement Testing is performed on the bag wall material. Select a representative fitting and cut the sample with a punch. The cutout of the sample should be large enough to overlap the sample holder sufficiently to ensure that when making measurements, material that may have been damaged or undesirably stretched by the cutting operation lies outside the measurement center. Thus, the sample is placed on the sample cup such that the cups are well overlapped. Orient the sample so that the surface exposed to the laboratory environment is the same as that seen during wearing of this product.

The closure ring of the sample cup is then placed on the sample and pushed down. In this way, the excess material is held firmly in place and does not interfere with the measurement. Wax is then applied to the entire surface of the closure ring to bring the entire fitting closer to the environment. Distilled water (5 ± 0.25 ml) is introduced into the sealed sample cup by a syringe via fine perforations. Finally, the perforations are sealed with silicone grease.

The entire cup (including sample and water) is weighed and the mass is recorded to four decimal places. The cup is then placed in the draft flow generated by the fan. The air flowing over the upper end of the sample cup was 3 ± 0.3 m / sec and the anemometer (“Anemo”, Delta
(Supplied by SpA, Italy). Keep the sample cup in the draft test area for 24 hours, then reweigh. During this time, the liquid in the sample holder can diffuse from the sample holder into the laboratory environment if the test sample is sufficiently breathable. As a result, the mass of water in the sample holder is reduced and can be quantified by reweighing all sample cups after 24 hours.

The vapor transmission value is determined by dividing the mass reduction by the opening area of the sample holder and converting it per day. That is, vapor permeable = mass loss ^{(g) / (0.003m 2/} 24 hours)

Air Permeation Test The Air Permeation Test is used to assess the ability of the bag urine management wear bag wall material to circulate / exchange air.

The basic principle of the method The basic principle of the test is to evaluate the resistance of the wall material to the passage of air. This test measures the volume (or amount) of air flowing through an article of a given size under standard conditions (23 ° C / 50% RH). The equipment used for the test is Te
x Air Permeabil from Test AG Switzerland
It is an imager FX3300.

The sample must be equilibrated with the test environment for at least 4 hours before the start of the measurement. The sample (having a measuring head dimension of more than 5 cm ² ) is placed on the fitting as per the manufacturer's instructions. A suction pump is set and air is sucked through the sample layer or structure to generate a pressure of 1210 kPa. The fitting measures the flow rate and pressure drop of the air that surrounds the orifice containing the sample and measuring head. Finally, the garment gives an air permeability value in the unit of "l / M ² s ¹ ".

Wet-Through Test The Wet-Through test is used to evaluate the resistance of a bag wall material or structure to the permeation of body exudates. This test directly assesses how liquid impermeable the porous wall material is to a wide range of body exudates by simply varying the composition of the test solution, as described in more detail in the method below. It can be used to measure.

Basic Principle of the Method The basic principle of the test is to simulate the loading of fecal management wear with bodily exudates. To do this, a sample fitting is prepared and held in a test stand mounted around the flange so that the outer surface of the wall material on the bag-facing side of the garment contacts the test stand (bottom). . A liquid delivery system capable of delivering the desired amount of the desired test liquid (preferably one or a series of steps) is suspended above the sample to be analyzed.

A piece of absorbent filter paper is placed between the garment facing surface of the bag wall material of the test sample and the transparent test stand. This absorbent filter paper is brought into intimate contact with the wall material of the test sample, for example when the fecal management garment is intimately contacted with clothing or a diaper. Underneath the transparent test stand is a mirror in a position such that any changes in the absorbent filter paper can be continuously observed (wetting body waste with a simulated colored solution). For example, if the porous bag wall material is not sufficiently resistant to liquid permeation, the filter paper will be wet with the colored solution, which can be observed in the mirror. In addition to the time dependence of permeation, the size of the permeated solution can be easily recorded as the mass or more preferably the size of the stain on the absorbent filter paper (simulating an undergarment or diaper).

The test solution is introduced into the test sample by a calibrated delivery system, such as a simple burette, according to the desired test approach detailed below. Once the bag is loaded with the test sample, allow the system to equilibrate for 1 minute.

After waiting for 1 minute, a pressure of 70 gsm (grams per square meter) is exerted on the test sample, which pressure is believed to reflect a more tense pressure than normally obtained during use. The test sample is held for 30 minutes at a pressure of 70 gsm and the measured value, eg the area of the colored stain on the absorbent paper, is measured at 5 minute intervals.

It is also important to understand the mechanism of wetting failure and to ensure that the correct test design can accurately evaluate this. For example, a breathable bladder wall material with relatively large openings (greater than 200 μm) will squirt relatively quickly when the test sample is placed under pressure (
The pressure exerted when sitting may cause liquid to pass through the larger opening) and is more likely to fail. Alternatively, simpler or capillary diffusion processes may be more likely to occur because the apertures are smaller (less than 200 μm). Such a process is slower than the ejection process.

This test design measures the impermeability of porous wall materials under high load (sudden, tense bursts of test solution) simulations.

The high squirt simulation test is performed in the same manner as the above general description under the following conditions in the case of the fecal management wearing device. Test solution: Synthetic urine + 1% Surfactant ejection volume (ml): 10 ml Ejection rate (ml / min): 10 (ie 10 ml in 60 seconds) Applied pressure: 70 gsm (after waiting 1 minute)

The results are reported as the area of stain / wetting in units of square cm (cm ² ) at the time course of 5, 10, 20 and 30 minutes.

Type and Volume of Test Solution Used in the Test Method In order to accurately evaluate potential bag wall materials, the test solution conditions must be compatible with the final use of the product. These excrements are quite different for different wearers and can contain varying levels of fatty acids and detergent-type contaminants from daily hygienic practices (washing, washing, etc.). These components can be very fluid and have very low surface tension. It has been found that due to body contaminants (fatty acids, surfactants and detergent residues) the addition of surfactants to synthetic urine correlates well with the conditions found during use. Its volume is again chosen to reflect the typical conditions under which this application will expose the product. For more stressful application methods, this method can be modified to facilitate higher loading volumes and delivery rates of test solutions for simulation.

Preparation of Test Solution Synthetic Urine + 1% Surfactant (Urea B / 1%) First, synthetic urine of the test solution was prepared as a 10 kg masterbatch, a small amount was taken as necessary, and a surfactant was added. To do. Each 10 kg Urea B batch is composed of the following components:

[0102] Component: molecular formula weight / 10 kg Batch urea 200g sodium chloride NaCl 90 g magnesium sulfate MgSO ₄ · 7H ₂ O 11g calcium chloride CaCl ₂ 6 g Distilled water H ₂ O 9693g

All reagents are "reagent grade" and obtained from standard chemical suppliers. further,
Surfactants are available from Pegesis, U.S.A. S. A. , Peosperse 200ML
Supplied from. In the individual measurements, 100 ml of the test solution urea B / 1% surfactant is prepared by mixing 90 ml of urea B solution with 10 ml of surfactant. The urea B / 1% solution must be mixed without interruption and it must be ensured that the components are not separated before use.

[Brief description of drawings]

It is believed that the present invention may be better understood by combining the above description with the accompanying drawings.

[Figure 1]   It is a top view of the disposable urine management wearing equipment of this invention.

[Fig. 2]   It is a side view of the disposable urine management attachment of FIG.

[Figure 3]   FIG. 3 is a sectional view taken along line 3-3 of FIG. 1.

[Figure 4]   It is a top view of another embodiment of the disposable urine management wearing equipment of the present invention.

[Figure 5]   5 is a cross-sectional view taken along line 5-5 of FIG.

[Figure 6]   It is sectional drawing of another embodiment of the disposable urine management wearing tool of this invention.

─────────────────────────────────────────────────── ─── Continuation of front page (51) Int.Cl. ⁷ Identification code FI theme code (reference) A61F 13/14 A61L 2/16 Z A61L 2/16 C08J 5/18 CER C08J 5/18 CER C08L 101: 00 // C08L 101: 00 A41B 13/02 R (31) Priority claim number 98124492.4 (32) Priority date December 28, 1998 (December 28, 1998) (33) Priority claiming country European Patent Office (EP) (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE), OA ( BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SL, Z, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY , CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG , SI, SK, SL, TJ, TM, TR, TT, UA, UG, US, UZ, VN, YU, ZA, ZW F term (reference) 3B029 BB02 BB05 BC02 BC03 BC06 BD12 BD19 BD21 BD22 4C058 AA16 BB07 CC08 EE13 JJ02 JJ26 4C098 AA09 CC01 CC18 CC19 CC21 CC23 CC24 CE02 CE06 CE14 DD01 DD02 DD05 DD06 DD08 DD10 DD12 DD13 DD14 DD16 DD19 DD21 DD22 DD23 DD25 DD26 DD30 4F071 AA02 AB03 AB18 AE22 AF08Y AF09Y AH19 BC01 BC02 BC10

Claims (9)

[Claims] 1. A urine management device (10) comprising a bag (11), said bag (11) having an opening (13) and said opening for adhesive attachment to a genitourinary region of a wearer. Having a surrounding flange (12), said flange (12) being attached to said bag (11), said bag (11) comprising wall material, said wall material being water vapor permeable and at least 250 g / (m). urine management attachment characterized by having a moisture vapor transport rate of ² · 24 hours) (10). 2. The urine management fitting according to claim 1, wherein the wall material has a water vapor transport rate of at least 300 g / (m ² · 24 hours).
). 3. The urine management device (10) of claim 2, wherein the wall material has an air permeability of at least 50 l / (m ² · s). 4. The urine management device (10) according to claim 1, characterized in that the wall material comprises at least one layer selected from monolithic films and microporous films. ). 5. The wall material comprises an inner layer (18) and an outer layer (17), the outer layer (17) is a nonwoven layer and the inner layer (18) is a monolithic film, and the inner layer (18) and the outer layer (18). The urine management fitting (10) according to any one of claims 1 to 4, characterized in that 17) is laminated in layers. 6. The wall material further comprises an odor control agent,
The urine management attachment according to any one of claims 1 to 5. 7. The urine management device (10) of claim 6, wherein the odor control agent is selected from silica, zeolite, chelating agents, activated carbon, and mixtures thereof. 8. A urine management device (10) according to any one of claims 1 to 7, characterized in that the bag (11) contains an absorbent material (15) therein. 9. The urine management wearing device (10) according to claim 1.
) And disposable diapers.