Incontinence products with pH regulator
Patent Information
- Application Number
- DE502019012878
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2019-12-20
- Publication Date
- 2025-02-20
- Estimated Expiration
- 2039-12-20
AI Technical Summary
Incontinence articles often cause skin irritation and inflammation due to prolonged contact with body excretions, particularly in older adults, where the skin's pH balance is disrupted by alkaline urine, leading to conditions like incontinent dermatitis, and existing pH control methods in incontinence products are inefficient due to uneven distribution of buffer components during manufacturing.
The use of particle-shaped pH regulatory agents like mononatrium citrate or dinatrium citrate, with at least 50% of the agent having a particle size of 10 to 2000 µm, which are less hygroscopic and easier to dose, ensuring a more even pH distribution and preventing sharp pH drops, thereby improving skin tolerance and reducing irritation.
The solution maintains a stable skin-friendly pH over multiple micturition events, reducing skin irritation and the need for frequent product changes, while also simplifying the manufacturing process and enhancing comfort by avoiding dust and abrasive issues.
Description
[0001] The present invention relates to an incontinence article for absorbing body excretions with a pH regulating agent for preferred use by adults.
[0002] A common problem with the continued use of incontinence products is the occurrence of skin irritation or inflammation caused by prolonged contact of the skin with bodily secretions such as urine. Incontinence-associated dermatitis (IAD), a skin inflammation in the perineal or perigenital region caused by contact with an irritant such as urine, is particularly common in older incontinent individuals. Changes in the pH of the skin upon contact with the more alkaline urine play a key role. The increased incidence of IAD in older individuals correlates with a weakened skin barrier with age and a reduced ability of the skin to renew itself. In addition, individuals suffering from incontinence for medical or age-related reasons often require the support of caregivers.Especially at night, the need for a restful night's sleep conflicts with the need for regular checking of the incontinence product used for prompt replacement after a voiding event. Therefore, prolonged skin contact with bodily secretions often occurs during this time. For individuals who experience frequent voiding events at short intervals, it would be beneficial, both for quality of life and for cost reasons, if the incontinence products did not have to be changed promptly after each voiding event.
[0003] Therefore, there is a need for incontinence products with improved skin compatibility, especially in cases of high urination frequency or longer change intervals.
[0004] Incontinence products for adults have long been known and often feature a topsheet that is at least partially permeable to liquids, a backsheet that is essentially impermeable to liquids, and an absorbent body arranged between the topsheet and the backsheet. These can be designed in a variety of ways, for example, as incontinence products that fit directly against the body or as absorbent incontinence pads.
[0005] The prior art includes approaches to providing incontinence products with a pH control agent. WO2012121932A1 teaches the use of a buffer solution comprising a weak acid or a weak base and the respective corresponding salt, such as citric acid and sodium citrate in a specific mixing ratio. In technical terms, the term sodium citrate refers to the tribasic sodium salt of citric acid, also known as trisodium citrate.
[0006] The inventors recognized that the use of a buffer mixture of citric acid and sodium citrate has the disadvantage that producing a homogeneous mixture is technically complex and can easily lead to at least partial demixing and uneven distribution of the individual components during the production process. This can lead to incorrect and non-specification-compliant addition of the components to incontinence products, which are typically produced in high-speed manufacturing machines. This poses the risk that the quantity and / or distribution of the components of the buffer mixture—and thus the assurance of the desired buffering effect when the products are used as intended—is subject to significant fluctuations between individual incontinence products or within an incontinence product.The risk of local accumulation of citric acid means that the pH value of the incontinence product in this area becomes highly acidic, meaning that the pH value in this area drops significantly below a value that is beneficial to the health of the skin.
[0007] The present invention is therefore based on the object of overcoming these disadvantages.
[0008] A further object of the invention is to provide incontinence articles with improved skin friendliness.
[0009] This object is achieved by an incontinence article for absorbing body excretions, comprising a topsheet that is at least partially liquid-permeable, a substantially liquid-impermeable backsheet, and an absorbent body arranged between the topsheet and the backsheet. The incontinence article comprises a pH regulating agent between the topsheet and the backsheet, at least partially, wherein the pH regulating agent comprises monosodium citrate or disodium citrate, wherein the pH regulating agent is particulate, with at least 50 percent by weight of the pH regulating agent having a particle size of 10 to 2000 µm. Thus, the pH regulating agent can preferably comprise either monosodium citrate or disodium citrate, or monosodium citrate and disodium citrate.
[0010] The incontinence product according to the invention allows a relatively consistent pH value to be achieved over several urination events. A further advantage of using monosodium citrate is that it is less hygroscopic than citric acid, for example, and therefore unwanted moisture ingress into the incontinence product before use can be avoided. Since monosodium citrate is less hygroscopic than citric acid, for example, it offers a further advantage in terms of better flowability, making it easier to dose.
[0011] The backsheet can, in particular, be formed from a breathable, yet essentially liquid-tight film material. The topsheet is preferably formed, at least in some areas, from a nonwoven-based material that is at least partially liquid-permeable.
[0012] In a preferred embodiment, the pH regulator additionally contains trisodium citrate; thus, the pH regulator can preferably contain either monosodium citrate and trisodium citrate, or disodium citrate and trisodium citrate, or monosodium citrate and disodium citrate and trisodium citrate. This allows for fine-tuning of the buffering effect of an incontinence article depending on the desired duration of use or the article's absorption capacity, without the risk of creating strongly acidic areas, as is the case with citric acid.
[0013] In such a case, the pH regulator preferably comprises a homogeneous mixture of the respective citrates. This has the advantage of avoiding local differences in the buffering effect of the pH regulator.
[0014] The terms monosodium citrate, disodium citrate, and trisodium citrate include both the non-hydrated form and hydrates of the respective substance.
[0015] In a preferred embodiment, the pH regulator consists of monosodium citrate.
[0016] In a further preferred embodiment, the pH regulator consists of disodium citrate.
[0017] Using only one component as a pH regulator offers process-related advantages, as no mixing of different components or maintenance of homogeneous mixing is required during the manufacturing process. Furthermore, a uniform buffering effect across the pH regulator-containing areas of the incontinence product is further supported.
[0018] It has proven advantageous if at least 50 percent by weight of the pH regulator has a particle size of 50 to 1200 µm, in particular 80 to 800 µm.
[0019] In principle, pH regulators with smaller or larger particle sizes are also available and can be used.
[0020] However, the described particle sizes offer the advantage that particles of such a size dissolve more slowly when wetted with body excretions such as urination fluid than pH regulators of smaller particle size, so that the pH regulator is not washed out as quickly during use and a pH regulating effect is maintained for longer on the upper side of the incontinence article facing the user's skin.
[0021] In addition, a pH regulator of the described particle size is easier to dose and incorporate into the incontinence product, especially in high-speed machines, than, for example, fine-powdered pH regulators, as there is less dust development and associated material loss during the manufacturing process.
[0022] On the other hand, particles of this size also offer the advantage that they are less noticeable to the touch during use of the incontinence product than, for example, granules with a larger particle size, which improves the wearing comfort of the incontinence product.
[0023] As an alternative to particulate pH regulating agent, the pH regulating agent can also be incorporated into the incontinence article in dissolved form, in particular as an aqueous or alcoholic solution, in particular by spraying or immersing and optionally subsequent drying of at least one absorbent body layer.
[0024] As a further alternative, an additional, particularly sheet-like material pretreated with the pH-regulating agent, in particular nonwoven material or cellulose material, can be included in the incontinence article. Such a sheet-like material can preferably be arranged between the fluid absorption layer and a storage layer of the absorbent body.
[0025] In a preferred embodiment, the amount of pH regulator is 10 to 100 g / m 2 , in particular 20 to 80 g / m 2 , more particularly 25 to 60 g / m 2 . The amount of pH regulator is based on the area of the flatly spread out incontinence article covered by the pH regulator. The above quantity of pH regulator is to be understood as referring to an anhydrous pH regulator, for example non-hydrated monosodium citrate. If the pH regulator comprises one or more hydrates or, as described below, more than 5%, in particular more than 10%, of additive substances, the total amount of pH regulator in g / m 2 is adjusted such that the total amount of pure and / or non-hydrated pH regulator contained corresponds to the above preferred amount.
[0026] Preferably, the monosodium citrate, disodium citrate, or trisodium citrate is used essentially in pure form, in particular with a purity of at least 90%, more particularly at least 95%, more particularly at least 98%, more particularly at least 99%, more particularly 100%. This largely prevents skin irritation caused by residues of other substances when using the incontinence product.
[0027] However, it is also conceivable for the pH regulator to contain a small amount of one or more additive substances, for example, finishing and / or conditioning agents such as release agents, stabilizers, dust binders, anticoagulants, wetting agents, coagulants, anticoagulants, adhesive or surface-active substances or antimicrobial substances, dyes or fragrances, or pH indicators. In such a case, the proportion of the one or more other substances in the total amount of the pH regulator is preferably less than 10%, more preferably less than 5%, more preferably less than 2%, more preferably less than 1%.
[0028] The absorbent body of the incontinence article is suitable and intended to absorb and permanently store body excretions, in particular body fluids, especially urine.
[0029] For this purpose, the absorption body advantageously comprises at least one storage layer, which preferably comprises a superabsorbent polymer (SAP).
[0030] Alternatively, the absorption body may also comprise more than one, in particular at least two storage layers.
[0031] The absorbent body may comprise one or more channels in one or more than one storage layer.
[0032] The absorption body may be rectangular, triangular, oval, T-shaped, hourglass-shaped, asymmetrical or in any other shape deemed suitable by a person skilled in the art.
[0033] In a preferred embodiment, the absorbent body contains 5-100 weight percent superabsorbent polymer material (SAP), preferably 10-95 weight percent, more preferably 15-90 weight percent, and most preferably 20-80 weight percent. Typically, the SAP material can absorb at least 15 times, in particular 20 times, its weight in 0.9 weight percent saline solution (measured according to NWSP 242.0.R2(15)).
[0034] The SAP material can, for example, be in particle or fiber form or in sheet or foam form.
[0035] The storage layer of the absorbent body can contain additional materials, such as cellulose fibers ("fluff") or synthetic fibers. It is also conceivable to form the storage layer of the absorbent body by arranging one or more layers of different materials, particularly nonwoven material.
[0036] According to a preferred embodiment, the storage layer is substantially free of the pH regulating agent.
[0037] Essentially free of pH regulator means that the respective layer of the absorbent body, in particular the storage layer, contains less than 10 g / m 2 , in particular less than 7 g / m 2 , more particularly less than 5 g / m 2 , more particularly less than 2 g / m 2 of pH regulator, and more particularly no pH regulator at all. This advantageously avoids any potential functional impairment of the respective layer, in particular the storage layer, and in particular of the SAP material preferably contained in the storage layer.
[0038] It is further preferred that the layer of the absorbent body directly facing the backsheet be substantially free of the pH regulating agent. This advantageously results in greater wearing comfort, particularly in the case of an incontinence article that fits close to the body, since a softer haptic impression of the incontinence article is achieved from the backsheet side. It is also known to those skilled in the art that particulate material can exert abrasive forces that can damage the substantially liquid-impermeable backsheet, in particular a liquid-impermeable backsheet film of the absorbent article, and lead to leakage of the article.A layer that is essentially free of pH regulator, in particular particulate pH regulator, and that faces directly towards the backsheet therefore has the advantage of reducing the risk of damage to the backsheet film during the manufacturing process or during use of the incontinence article.
[0039] It is also advantageous if the incontinence article comprises a fluid absorption layer, which forms a layer of the absorbent body directly facing the topsheet. This allows any fluid generated during a urination event to be quickly absorbed, distributed, and transferred to the at least one storage layer.
[0040] Layers for the rapid absorption and distribution of body excreta, so-called fluid absorption or distribution layers, are already known in the art and typically consist of a fibrous material, particularly a nonwoven material. The fibers can be of natural or synthetic origin and can be of defined length (staple fibers) or continuous ("endless") or formed in situ. The fibers can be formed from a single polymer or a polymer blend (monocomponent fiber) or from more than one single polymer and / or a polymer blend (multicomponent fiber).
[0041] A multicomponent fiber has a cross-section comprising more than a single section, each of which comprises a different polymer or polymer blend. The term multicomponent fiber includes, but is not limited to, a bicomponent fiber. The various components of multicomponent fibers are arranged in substantially distinct regions across the cross-section of the fiber and extend continuously along the length of the fiber. A multicomponent fiber may have an overall cross-section comprising subsections of the two or more different components of any shape or arrangement, including, for example, coaxial subsections, core and sheath subsections, juxtaposed subsections, radial subsections, island-shaped subsections, etc.
[0042] A bicomponent fiber having a "core / sheath structure" has a cross-section comprising: two discrete sections, each consisting of a polymer or polymer blend, wherein the sheath polymer or sheath polymer blend component is disposed around the core polymer or core polymer blend component.
[0043] The basis weight of nonwoven materials is usually given in grams per square meter (g / m 2< ).
[0044] In a preferred embodiment, the fluid absorption layer comprises multicomponent fibers, in particular bicomponent fibers, more particularly bicomponent fibers containing polyester, so-called Bico / PES fibers. The multicomponent fibers, in particular the bicomponent fibers, preferably have a circular or trilobal cross-section.
[0045] Preferred combinations of components in bicomponent fibers are polyethylene terephthalate (PET) / polyethylene (PE), PET / polypropylene (PP), PET / polyester copolymers (CoPET), polylactic acid (PLA) / polylactide copolymers (COPLA), PLA / PE and PLA / PP.
[0046] As an alternative, it is known in the art to use a material made of chemically modified cellulose fibers, for example cross-linked cellulose fibers, as a liquid absorption layer.
[0047] The liquid absorption layer may also comprise or consist of other materials such as perforated films or foams or the like.
[0048] The fluid absorption layer can overlap the at least one storage layer of the absorbent body essentially completely or only partially, thus having essentially the same areal extent or at least a smaller extent, in some regions, than the at least one storage layer and / or the layer of the absorbent body directly facing the backsheet in the longitudinal and / or transverse direction of the flat incontinence article. The fluid absorption layer preferably overlaps the at least one storage layer and / or the layer of the absorbent body directly facing the backsheet by 5-100%, in particular by 10-90%, further in particular by 15-80%, further in particular by 20-70% of its areal extent.
[0049] Preferably, the fluid absorption layer is arranged at least in one area where the micturition fluid impinges on the incontinence article during use. In particular, the fluid absorption layer extends over and in the area of a transverse central axis of the absorbent body.
[0050] In a preferred embodiment, the pH regulating agent is positioned substantially between the liquid absorption layer and an absorbent body layer facing the backsheet. In particular, at least 70 weight percent, more particularly 80 weight percent, more particularly at least 90 weight percent, more particularly at least 95 weight percent of the pH regulating agent is positioned between the liquid absorption layer and the absorbent body layer facing the backsheet.
[0051] Preferably, the pH regulating agent does not touch the topsheet in the dry state of the incontinence article, in particular at least 70 percent by weight, more particularly 80 percent by weight, more particularly at least 90 percent by weight, more particularly at least 95 percent by weight of the pH regulating agent is positioned between a layer of the absorbent body facing the topsheet, in particular the liquid absorption layer, and the layer of the absorbent body closest in the direction of the backsheet.
[0052] This advantageously results in the pH regulating agent being arranged on an upper side of the fluid absorption layer or another absorbent body layer facing away from the user's skin when the incontinence article is used and, in particular, is not in direct contact with the user's skin.
[0053] Alternatively, the pH regulating agent can be positioned substantially between an upper side of the liquid absorption layer facing the topsheet and the absorbent body layer facing the backsheet, in particular substantially within the liquid absorption layer.
[0054] It proves advantageous if the pH value on the upper side of the incontinence article facing the skin is between 4.8 and 6.5, in particular between 5.0 and 6.2, more particularly between 5.2 and 6.0, more particularly between 5.3 and 5.8, more particularly between 5.4 and 5.6. It is preferred if the incontinence article maintains a skin-friendly pH value over at least two, in particular at least three micturition events.
[0055] An advantageous further development of the embodiments described above is an arrangement of incontinence articles, wherein the arrangement comprises at least two, in particular at least three, further in particular at least four, further in particular at least five, further in particular at least six incontinence articles, wherein at least a first incontinence article and a second incontinence article of the arrangement differ in at least one feature selected from the group size, absorption capacity according to ISO 11948-1 (1996), amount of pH regulating agent in g / m 2< , total amount of pH regulating agent per incontinence article, number of absorbent body layers
[0056] The total amount of pH regulating agent per incontinence article, which is intended in particular for use by adults, is preferably 0.2 to 3.0 g, more preferably 0.4 to 2.5 g, more preferably 0.6 to 2.0 g.
[0057] Incontinence articles of a preferred arrangement differ from one another in the amount of pH regulator in g / m or in the total amount of pH regulator per incontinence article or absorption capacity according to ISO 11948-1 (1996) if the first incontinence article has a respective value which is at least 20%, in particular at least 30%, further in particular at least 40%, further in particular at least 50%, further in particular at least 75%, further in particular at least 100% higher than the respective value of the second incontinence article.
[0058] An arrangement results from the obvious arrangement of the incontinence products belonging to the arrangement, in particular through the relationship or relationship of the products to one another. This occurs either by presentation in a common packaging unit and / or preferably by the affixing of markings to the incontinence products and / or their packaging and / or by presentation in spatial or content proximity to one another, which indicates their belonging to an arrangement. The incontinence products comprising the arrangement preferably originate from one and the same manufacturer.
[0059] The incontinence products forming an arrangement preferably have the same product labeling, such as brand names and / or sub-brand names.
[0060] An arrangement of incontinence articles of a first manifestation of a feature and incontinence articles of a second manifestation of a feature, such as a first size and a second size, is understood as at least one representative thereof and includes a plurality of the incontinence articles of a first manifestation of a feature and / or the incontinence articles of a second manifestation of a feature or packs and packaging units containing such.
[0061] Furthermore, the arrangement can comprise at least two, in particular at least three, further in particular at least four, further in particular at least five, further in particular at least six incontinence articles, wherein at least a first incontinence article and a second incontinence article of the arrangement are different incontinence articles selected from the group incontinence pad, open-type incontinence diaper with closure systems, closed-type incontinence diaper, and hospital pad.
[0062] Further features, details, and advantages of the invention will become apparent from the appended claims and from the drawings and the following description of preferred embodiments of the invention and examples. The drawing shows: Figure 1 schematic representation in plan view of an open-type incontinence diaper with closure elements as an embodiment of an incontinence article according to the invention Figure 2a schematically, a cross-section through an incontinence article with a storage layer with SAP material, a fluid absorption layer and pH regulating agent arranged in between Figure 2b schematic, a cross-section through an incontinence article with two storage layers, SAP material, a fluid absorption layer and pH regulating agent arranged in between Figure 3 schematic, positions of measuring points for surface measurement of pH values relative to a liquid absorption layer
[0063] The Figure 1shows, not to scale, but schematically, an incontinence article according to the invention, designated overall by the reference numeral 17, for example an open-type incontinence diaper with closure elements in the so-called T-shape for adults. The incontinence diaper 17 comprises a main part (chassis), designated overall by the reference numeral 65, with a body fluid-absorbing absorbent body 69. In this exemplary embodiment, the absorbent body 69 comprises at least one storage layer 70, which comprises SAP material (in Figure 1 not shown) and a liquid absorption layer 71. The incontinence diaper 17 according to the invention contains a pH regulating agent 72 which is arranged substantially between the liquid absorption layer 71 and the at least one storage layer 70 of the absorbent body, as in Figures 2a and 2bdescribed in more detail. The absorbent body 69 is arranged between two flat materials, namely a topsheet 80 that is at least partially liquid-permeable and a substantially liquid-impermeable backsheet 81 of the diaper main body 65.
[0064] In the incontinence diaper 17, a longitudinal direction 73 and a transverse direction 74 of the incontinence diaper 17 can be distinguished, the latter corresponding to a hip circumference direction of the user when the incontinence diaper is worn. The main part 65 comprises a front region 82 with front lateral longitudinal edges 83, a back region 64 with a first rear lateral longitudinal edge 66 and a second rear lateral longitudinal edge 67, and a crotch region 84 arranged therebetween. Adjacent to a respective longitudinal edge 85 of the crotch region 84, the main part 65 has an elasticized section, thus an elasticized leg opening section 86.In the case shown, these elasticized leg opening sections 86 are formed by elastic threads running between the topsheet 80 and the backsheet 81 and fixed to the topsheet 80 and / or backsheet 81 in a pre-tensioned state, which are curved in an arcuate manner and thus oriented with at least one component in the longitudinal direction 73 of the incontinence diaper 17.
[0065] In the T-shaped incontinence diaper 17, a first elastic diaper side part 62 extending laterally beyond the first rear lateral longitudinal edge 66 and a second elastic diaper side part 63 extending laterally beyond the second rear lateral longitudinal edge 67 are provided in the back region 64 of the main part 65 in the transverse direction 74 of the incontinence diaper 17. These first elastic diaper side parts 62 and 63 are permanently attached to the back region 64 of the main part 65 in an overlap region 87 in the region of the rear lateral longitudinal edges 66 and 67, respectively. In the front region 82, however, no diaper side parts are provided.
[0066] In an alternative embodiment, the incontinence diaper can also be designed as an H-shaped incontinence diaper, in which case diaper side parts are additionally formed in the front region and preferably on both sides, as shown, for example, in WO2005102241A1. As a further embodiment, an incontinence diaper of the closed type is also conceivable, in which case a belly and back part is preferably attached in the front region and in the back region, which are joined together at respective lateral longitudinal edges of the belly and back parts such that the incontinence diaper is closed in a ring shape in the hip circumferential direction, as shown, for example, in WO2013171068A1. As a further embodiment, the incontinence article 17 can be designed as a hospital underpad or incontinence pad.
[0067] The first elastic diaper side part 62 and the second elastic diaper side part 63 of the T-shaped incontinence diaper 17 each have at least one closure element 44 in the region of their free end 88 in the transverse direction 74 of the incontinence diaper 17. The closure element 44 is designed in the form of a preferably rectangular tab and folded upon itself by the manufacturer. In use, the closure element 44 can be opened, i.e. unfolded again, in order to apply the incontinence diaper 17 to a user, wherein the first elastic diaper side part 62 and the second elastic diaper side part 63 are brought into overlap with the front region 82 of the main part 65 and the closure elements 44 are releasably and adhesively secured to the side of the front region 82 of the main part 65 facing away from the user.
[0068] The Figures 2a and 2bshow, by way of example and not to scale, a cross-section through an incontinence article 18a, 18b, for example an incontinence diaper of the open type with closure systems (as in Figure 1 described in more detail) or a closed-type incontinence diaper or an incontinence pad or a patient underpad. The incontinence articles 18a, 18b comprise a liquid-permeable topsheet 80, a substantially (thus in use) liquid-impermeable backsheet 81, and an absorbent body 76 arranged therebetween. The absorbent body 76 of the incontinence article 18a ( Figure 2a )comprises a storage layer 70 with fiber material 70a, such as cellulose fibers or plastic fibers, and SAP material 70b, a liquid absorption layer 71, and a pH regulating agent 72 arranged therebetween. The liquid absorption layer 71 forms a layer of the absorbent body 76 directly facing the topsheet 80. The storage layer 70 directly faces the backsheet and is substantially free of the pH regulating agent 72. The absorbent body of the incontinence article 18b ( Figure 2b ) additionally comprises a further layer, namely a layer 75 of the absorption body 76 directly facing the backsheet 81, which consists essentially of fiber material 70a, such as cellulose fibers or plastic fibers, and is arranged between the storage layer 70 and the backsheet 81. The layer 75 directly facing the backsheet 81 is essentially free of pH regulator 72.
[0069] In the Figures 2a and 2b In the illustrated embodiments, the pH regulator 72 comprises particulate monosodium citrate, type "Fine Granular F3500" from Jungbunzlauer. This monosodium citrate has a particle size of 80 to 355 µm at 59% by weight and a purity of at least 99%. The amount of pH regulator 72 in this example is 30 g / m². In principle, any monosodium citrate that appears suitable to a person skilled in the art and corresponds to the description of the invention can be used as the pH regulator.
[0070] In the illustrated cases, the SAP material 70b is in particle form. In a conceivable variant, the SAP material can be fibrous, sheet-like, or foam-like.
[0071] The two Figures 2a and 2bshow the cross section through the incontinence articles 18a and 18b respectively in the transverse direction 74, in the case of an incontinence diaper 17 for example in the crotch area (reference number 84 in Figure 1 , without showing the elasticized leg opening sections 86).
[0072] The liquid absorption layer 71 only partially overlaps the storage layer 70 of the absorption body 76 and in this case has a smaller extension than the storage layer 70 ( Figure 2a ) or the storage layer 70 and the layer 75 of the absorption body 76 directly facing the backsheet 81 ( Figure 2b ) in the transverse direction 74 of the flat incontinence article 18. Alternatively, the fluid absorption layer can completely overlap the storage layer and / or the layer 75 of the absorbent body 76 directly facing the backsheet 81. In this example, the storage layer 70 is ( Figure 2b ) in the transverse direction 74 extends substantially the same as the layer 75 of the absorption body 76 directly facing the backsheet 81. However, the storage layer 70 and the layer 75 of the absorption body 76 directly facing the backsheet 81 can also be extended differently. Example 1: pH regulation by monosodium citrate or disodium citrate compared to citric acid
[0073] 1A: An adult incontinence diaper was manufactured with a pH regulator consisting of monosodium citrate (first incontinence diaper 1A, according to the invention). The incontinence diaper 1A comprised the following components in the specified arrangement: Topsheet: SMS nonwoven material, 12 g / m 2 , type 3000063 from Avgol LTD Fluid absorption layer: Nonwoven material carded and thermally bonded ("airthroughbonded"), Bico / PES, 40 g / m 2 , dimensions 90 x 270 mm (0.0243 m 2 ), type 11040WC0A from Berry pH regulator: 25 g / m 2 monosodium citrate, purity >95%, non-hydrated, total amount per incontinence article 0.6 g, calculated total molar amount of monosodium citrate per incontinence article 0.003 mol, catalog number 21533 from Thermo Fisher Scientific Storage layer: 21.5 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute; mixed with 13.5 g particulate SAP material (type SXM 9791 from Evonik) Backsheet facing layer of the absorption body: 34.8 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute Backsheet: nonwoven film laminate, 18 g / m 2< , Hyfol PE soft Textile type 14202 from RKW
[0074] 1B: Another adult incontinence diaper was manufactured with a pH regulator consisting of disodium citrate (second incontinence diaper 1B, for comparison, according to the invention). Incontinence diaper 1B had the following components in the specified arrangement: Topsheet: SMS nonwoven material, 12 g / m 2 , type 3000063 from Avgol LTD Fluid absorption layer: Nonwoven material carded and thermally bonded ("airthroughbonded"), Bico / PES, 40 g / m 2 , dimensions 90 x 270 mm (0.0243 m 2 ), type 11040WC0A from Berry pH regulator: 31 g / m 2 disodium citrate, purity 99%, hydrate form (disodium hydrogen citrate sesquihydrate), total amount per incontinence article 0.75 g, calculated total molar amount of disodium citrate per incontinence article 0.003 mol, catalog number 25024 from Thermo Fisher Scientific Storage layer: 21.5 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute; mixed with 13.5 g particulate SAP material (type SXM 9791 from Evonik) Backsheet facing layer of the absorption body: 34.8 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute Backsheet: nonwoven film laminate, 18 g / m 2< , Hyfol PE soft Textile type 14202 from RKW
[0075] 1C: Another adult incontinence diaper was manufactured with a pH regulator consisting of citric acid (third incontinence diaper 1C, for comparison, not according to the invention). Incontinence diaper 1C had the following components in the specified arrangement: Topsheet: SMS nonwoven material, 12 g / m², type 3000063 from Avgol LTD Fluid absorption layer: Nonwoven material carded and thermally bonded ("airthroughbonded"), Bico / PES, 40 g / m², dimensions 90x270 mm (0.0243 m²), type 11040WC0A from Berry pH regulator: 26 g / m² citric acid, purity at least 99.5%, non-hydrogenated, total amount per incontinence article 0.625 g, calculated total molar amount of citric acid per incontinence article 0.003 mol, article number 471A1F, "citric acid anhydrous pharm" from Barcelonesa Storage layer: 21.5 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute; mixed with 13.5 g particulate SAP material (type SXM 9791 from Evonik) Backsheet facing layer of the absorption body: 34.8 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute Backsheet: nonwoven film laminate, 18 g / m 2< , Hyfol PE soft Textile type 14202 from RKW
[0076] The pH regulating agent was arranged between the fluid absorption layer and the storage layer in the first 1A and second 1B and third incontinence diapers 1C.
[0077] For better comparability of the pH regulation in the first 1A and second 1B and third incontinence diaper 1C, the respective total amount of pH regulating agent per incontinence article was selected so that there was essentially an equal molar total amount of 0.003 mol of the respective pH regulating agent per incontinence article (see Table 1). Table 1: pH regulators used in Example 1 1A (with MNC) 1B (with DNC) 1C (with CS) Crystal water not hydrogenated sesquihydrate not hydrogenated Molarity [g / mol] 214,11 263,1 192,13 Total quantity per incontinence product [g] 0,6 0,75 0,625 Area covered by pH regulator [m 2< ] 0,0243 0,0243 0,0243 Amount of pH regulator [g / m 2< ] 25 31 26 total molar amount per incontinence product [mol] 0,003 0,003 0,003 MNC, monosodium citrate; DNC, disodium citrate; CS, citric acid
[0078] As described in more detail below in the test method section, three consecutive micturition events were simulated with a urine replacement fluid and the pH values were measured on a respective outer upper side of the topsheet of the first and second and third incontinence articles in the region of the fluid absorption layer 71. Figure 3shows the positions of four measuring points 3 relative to the fluid absorption layer 71 of the first, second, and third incontinence articles (viewed toward the topsheet). The transverse dimension A of the fluid absorption layer 71 was 90 mm in each case. The longitudinal dimension B of the fluid absorption layer 71 was 270 mm. The pH value was measured at all four measuring points 3, and an average value was calculated from the four measured values per time point, which is shown in Table 3. A mean value and a corresponding standard deviation were also calculated from the average pH values obtained after each simulated urination, and these values are also shown in Table 3.The measuring points 3 were distributed in the longitudinal direction 73 of the respective liquid absorption layer such that a distance e between a measuring point 3 located closest in the longitudinal direction 73 to a respective transverse edge 1 of the liquid absorption layer 71 and the respective transverse edge 1 closest in the longitudinal direction 73 was 45 mm. A distance d between two consecutive measuring points 3 in the longitudinal direction 73 was 60 mm in this example.
[0079] A distance c between a measuring point 3 located closest in the transverse direction 74 to a respective longitudinal edge 2 of the respective liquid absorption layer 71 and the respective longitudinal edge 2 closest in the transverse direction 74 was 25 mm. A distance f between two consecutive measuring points 3 in the transverse direction 74 was 40 mm in this example.
[0080] The respective fluid volumes of the three simulated micturitions are Table 2 can be found. Table 2: Volumes of urine replacement fluid used in Example 1 Liquid volume [ml] Share of maximum absorption capacity [%] First simulated micturition 300 45 Second simulated micturition 150 22,5 Third simulated micturition 150 22,5 sum 600 90
[0081] The pH values measured at the four measuring points 3 described at different times are Table 3 can be found. Table 3: pH regulation, monosodium citrate and disodium citrate compared to citric acid, pH values assigned to individual time points are average values from four measurements each first simulated micturition second simulated micturition third simulated micturition Time [min]* 1A (with MNC) 1B (with DNC) 1C (with CS) 1A (with MNC) 1B (with DNC) 1C (with CS) 1A (with MNC) 1B (with DNC) 1C (with CS) 1 5,2 5,0 4,3 5,4 5,7 5,4 5,3 5,7 5,4 3 5,3 5,3 4,0 5,4 5,6 5,3 5,5 5,7 5,3 5 5,2 5,3 4,3 5,5 5,5 5,3 5,4 5,7 5,4 10 5,3 5,1 4,5 5,5 5,4 5,3 5,5 5,8 5,4 15 5,2 5,3 4,1 5,4 5,7 5,4 5,5 5,7 5,6 20 5,1 5,3 4,3 5,5 5,6 5,4 5,5 5,6 5,7 MW 5,2 5,2 4,3 5,5 5,6 5,4 5,5 5,7 5,5 SD 0,1 0,1 0,2 0,1 0,1 0,1 0,1 0,1 0,1 MNC, monosodium citrate; DNC, disodium citrate; CS, citric acid; MW, mean of the pH values of the micturition indicated in the column heading; SD, standard deviation * after the respective simulated micturition
[0082] The third incontinence diaper, 1C, with citric acid, resulted in pH values of 4.0 to 4.5 after the first simulated micturition, with a mean pH of 4.3 ± SD=0.2, well below the skin-friendly range. Only after the second and third simulated micturitions, two and five hours after the start of the test, did a skin-friendly pH value in the range of 5.4 to 5.5 (mean pH 5.4 ± SD=0.1 and pH 5.5 ± SD=0.1) become apparent.
[0083] The second incontinence diaper 1B with disodium citrate already resulted in skin-friendly pH values of pH 5.0 to 5.3 after the first simulated micturition (mean pH 5.2 ± SD=0.1) and increased only slightly after the second and third simulated micturition (mean pH 5.6 ± SD=0.1 and pH 5.7 ± SD=0.1).
[0084] The first incontinence diaper 1A with monosodium citrate also maintained a relatively constant skin-friendly pH of 5.1 to 5.5 over three simulated micturition events and, in particular, kept the pH constant at pH 5.4 to 5.5 after the second and third simulated micturitions (mean values pH 5.5 ± SD=0.1 in each case).
[0085] In particular, it was surprising that both the first 1A and the second incontinence diaper 1B had approximately the same and skin-friendly pH after the first simulated micturition (mean pH 5.2 ± SD=0.1 in each case), but a significantly higher pH than the third incontinence diaper 1C with citric acid (mean pH 4.3 ± SD=0.2), even though all three incontinence diapers contained essentially the same total molar amount of pH regulator (0.003 mol each). It was also surprising that the pH values of both the first 1A and the second incontinence diaper 1B did not increase, or did not increase significantly more, after the second and third simulated micturitions than the pH values of the incontinence diaper 1C with citric acid (mean Table 3).
[0086] The first incontinence diaper 1A with monosodium citrate achieved only slightly better pH regulation over the entire test duration than the second incontinence diaper 1B with disodium citrate, with essentially the same total molar amount of pH regulator (0.003 mol each). Compared to the hydrogenated disodium citrate used in this example, approximately 20% less pH regulator by weight can be used when using monosodium citrate. Thus, in addition to the process-related advantages described above, the choice of pH regulator can also result in economic and logistical advantages. Example 2: pH regulation by a pH regulator consisting of citric acid and trisodium citrate
[0087] 2A: An adult incontinence diaper was manufactured with a pH regulator known from the prior art (WO2012121932A1) consisting of a mixture of trisodium citrate and citric acid, with a mixing ratio of 6.2:1 (w / w) (fourth incontinence diaper 2A, for comparison, not according to the invention). The incontinence diaper 2A comprised the following components in the specified arrangement: Topsheet: SMS nonwoven material, 12 g / m 2 , type 3000063 from Avgol LTD Fluid absorption layer: Nonwoven material carded and thermally bonded ("airthroughbonded"), Bico / PES, 40 g / m 2 , dimensions 90x270 mm (0.0243 m 2 ), type 11040WC0A from Berry pH regulator: 31 g / m 2 (total amount per incontinence article 0.75 g) Trisodium citrate: Citric acid 6.2:1 (w / w) Storage layer: 21.5 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute; mixed with 13.5 g particulate SAP material (type SXM 9791 from Evonik) Backsheet facing layer of the absorption body: 34.8 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute Backsheet: nonwoven film laminate, 18 g / m 2< , Hyfol PE soft Textile type 14202 from RKW
[0088] 2B: An adult incontinence diaper was manufactured with a pH regulator known from the prior art (WO2012121932A1) consisting of a mixture of trisodium citrate and citric acid, with a mixing ratio of 7.2:1 (w / w) (fifth incontinence diaper 2B, for comparison, not according to the invention). The incontinence diaper 2B comprised the following components in the specified arrangement: Topsheet: SMS nonwoven material, 12 g / m 2 , type 3000063 from Avgol LTD Fluid absorption layer: Nonwoven material carded and thermally bonded ("airthroughbonded"), Bico / PES, 40 g / m 2 , dimensions 90x270 mm (0.0243 m 2 ), type 11040WC0A from Berry pH regulator: 31 g / m 2 (total amount per incontinence article 0.75 g) Trisodium citrate: Citric acid 7.2:1 (w / w) Storage layer: 21.5 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute; mixed with 13.5 g particulate SAP material (type SXM 9791 from Evonik) Backsheet facing layer of the absorption body: 34.8 g cellulose fibers ("fluff"), type CoosAbsorb S from Resolute Backsheet: nonwoven film laminate, 18 g / m 2< , Hyfol PE soft Textile type 14202 from RKW
[0089] The trisodium citrate used in the fourth 2A and fifth incontinence diapers, 2B, had a purity of >99% and was present as a dihydrate (article number 27833.363 from VWR chemicals). The citric acid was present in the non-hydrogenated form and had a purity of at least 99.5% (article number 471A1F, "citric acid anhydrous pharm" from Barcelonesa).
[0090] The pH regulator was arranged between the fluid absorption layer and the storage layer in the fourth 2A and fifth incontinence diapers 2B.
[0091] As further described in relation to Example 1 and in the test method section, three consecutive micturition events were simulated with a urine replacement fluid and the pH values were measured on the respective outer upper side of the topsheet of the fourth and fifth incontinence articles in the region of the fluid absorption layer 71. Figure 3shows the positions of the four measuring points 3 relative to the fluid absorption layer 71 of the fourth and fifth incontinence article from the viewpoint of the topsheet. The transverse dimension A of the fluid absorption layer 71 was 90 mm in each case. The longitudinal dimension B of the fluid absorption layer 71 was 270 mm. The pH value was measured at all four measuring points 3, and an average value was calculated from the four measured values per time point, which is shown in Table 5. A mean value and the corresponding standard deviation were also calculated from the average pH values obtained after each simulated urination and also shown in Table 5The measuring points 3 were distributed in the longitudinal direction 73 of the respective liquid absorption layer such that a distance e between a measuring point 3 located closest in the longitudinal direction 73 to a respective transverse edge 1 of the liquid absorption layer 71 and the respective transverse edge 1 closest in the longitudinal direction 73 was 45 mm. A distance d between two consecutive measuring points 3 in the longitudinal direction 73 was 60 mm in this example.
[0092] A distance c between a measuring point 3 located closest in the transverse direction 74 to a respective longitudinal edge 2 of the respective liquid absorption layer 71 and the respective longitudinal edge 2 closest in the transverse direction 74 was 25 mm. A distance f between two consecutive measuring points 3 in the transverse direction 74 was 40 mm in this example.
[0093] The fluid volumes of the three simulated micturitions are Table 4 can be found. Table 4: Volumes of urine replacement fluid used in Example 2 Liquid volume [ml] Share of maximum absorption capacity [%] First simulated micturition 300 45 Second simulated micturition 150 22,5 Third simulated micturition 150 22,5 sum 600 90
[0094] The pH values measured at the different times at the described measuring points 3 are Table 5 can be found. Table 5: pH regulation, pH regulator consisting of citric acid and trisodium citrate, pH values assigned to individual time points are average values from four measured values each first simulated micturition second simulated micturition third simulated micturition Time [min]* 2A (6,2:1) 2B (7,2:1) 2A (6,2:1) 2B (7,2:1) 2A (6,2:1) 2B (7,2:1) 1 5,7 5,6 5,8 5,7 5,9 5,8 3 5,5 5,7 5,8 5,8 5,9 5,9 5 5,7 5,7 5,8 5,8 5,8 5,9 10 5,6 5,6 5,9 5,8 5,8 5,8 15 5,6 5,7 5,9 5,8 5,9 5,8 20 5,6 5,7 5,9 5,8 5,9 5,8 MW 5,6 5,7 5,9 5,8 5,9 5,8 SD 0,1 0,1 0,1 0,0 0,1 0,1 MW, mean of the pH averages of the micturition indicated in the column heading; SD, standard deviation * after the respective simulated micturition
[0095] The fourth and fifth incontinence diapers 2A and 2B, containing the known pH regulator consisting of a mixture of trisodium citrate and citric acid in various ratios, resulted in pH values of 5.5 to 5.7 after the first simulated urination. After the second and third simulated urination, the respective pH values in the fourth and fifth incontinence diapers rose to relatively high pH values of 5.7 to 5.9. Despite different ratios of trisodium citrate and citric acid, the fourth and fifth incontinence diapers 2A and 2B showed approximately the same pH regulation, so that in this example, neither ratio offered an advantage over the other.
[0096] A summary of the two examples 1 and 2 shows that the pH regulator comprising monosodium citrate of the first incontinence diaper 1A or disodium citrate of the second incontinence diaper 1B was superior to all of the other tested third 1C, fourth 2A and fifth incontinence diapers 2B, since the pH values of the first 1A and second incontinence diaper 1B were within the skin-friendly range across all three simulated micturitions, in particular the pH values remained relatively constant within a narrow range, and furthermore in particular there was no significant decrease in the pH values after the first micturition and no significant increase even over more than 5 hours with a total of three simulated micturitions. Test method pH measurement on the surface of an incontinence product:
[0097] A urine replacement solution is used to perform a pH measurement on the surface of an incontinence product, particularly on the outer surface of the topsheet of the incontinence product. The urine replacement solution is a 0.9% (w / v) solution of sodium chloride (NaCl) in distilled water, prepared according to ISO 11984-1 (1996), which is adjusted to pH 6.8 with sodium hydroxide (NaOH). Such a solution has long been known in the general art, and its preparation is one of the routine methods in the field.
[0098] The incontinence product to be tested is laid out flat with the topsheet side facing upwards, unfolded completely if necessary and fixed to a base if necessary.
[0099] The test is conducted according to ISO 11984-1 (1996) at a temperature of 23 °C ± 2 °C and a relative humidity of 50% ± 5%. The incontinence product to be tested and the urine substitute fluid are preconditioned accordingly according to ISO 11984-1 (1996).
[0100] In order to simulate a usage situation as realistically as possible and to monitor the pH development or the buffering effect of the pH regulator over a longer period of use with multiple micturition events, three micturition events are simulated over a period of five hours, as described below. The incontinence product is loaded with a total fluid volume corresponding to approximately 90% of the incontinence product's maximum absorption capacity.
[0101] The volumes of the first, second, and third simulated micturitions should therefore be selected so that the total volume of the first, second, and third simulated micturitions corresponds to approximately 90% of the maximum absorption capacity of the incontinence product. The volume of a first simulated micturition corresponds to 45% to 50% of the maximum absorption capacity of the incontinence product. The respective volumes of a second and a third simulated micturitions are essentially the same, each corresponding to 20% to 22.5% of the maximum absorption capacity.
[0102] If the maximum absorption capacity of an incontinence product is not known, the maximum absorption capacity shall be determined in advance in accordance with ISO 11984-1 (1996) using a second comparable incontinence product, for example an incontinence product of the same absorbency, size and product type and, if applicable, taken from the same package as the incontinence product to be tested.
[0103] A volume of urine replacement solution corresponding to 50% of the maximum absorption capacity of the incontinence product is poured onto the dry incontinence product within 30 seconds to simulate a first urination. This is done in such a way that the urine replacement solution hits the incontinence product in an area in which the urination fluid would also hit the incontinence product during a urination event in the in-use state. If this area cannot be determined beyond doubt, the urine replacement solution should hit the absorbent body centrally, particularly in the region of a transverse central axis of the absorbent body. If the incontinence product has a fluid absorption layer or distribution layer, the urine replacement solution is poured onto the incontinence product centrally within an area formed by the fluid absorption layer or distribution layer.
[0104] Two hours after the start of the first simulated micturition with the first volume of urine replacement solution, a second volume of urine replacement solution corresponding to 20% of the maximum absorption capacity of the incontinence device is poured onto the incontinence device as described above to simulate a second micturition.
[0105] Five hours after starting to load the first volume of urine replacement solution, a third volume of urine replacement solution, corresponding to 20% of the maximum absorption capacity of the incontinence device, is poured onto the incontinence device as described above to simulate a third voiding.
[0106] After each of the three simulated micturition events, the pH value on the outer surface of the topsheet of the incontinence product is measured 1, 3, 5, 10, 15, and 20 minutes after the end of the respective simulated micturition. For this purpose, the pH value is measured at four measuring points each, spaced apart longitudinally and / or transversely across the flatly laid out incontinence product, and an average of the four measured values is calculated. If a fluid absorption layer or distribution layer is present, the measurements should be taken within the area formed by this layer. In any case, the measuring points must be located within an area covered by pH regulating agent.
[0107] The measuring points should be spaced apart from one another and, in particular, at least not overlap. It is important to ensure that the measuring points on the incontinence product are not too dry in order to obtain reliable measurement results. The positions of the four measuring points should preferably be maintained for all measurements, but it is also possible to vary the position of one or more measuring points, for example if a measuring point is too dry at the time of a later measurement. This can be the case, for example, with incontinence products with particularly low rewetting, particularly 15 and / or 20 minutes after the respective simulated micturition. If at least two suitable measuring points are not available for a measurement, the measurement is only evaluated at times 1, 3, 5, 10 and, if applicable, 15 minutes after the end of the respective simulated micturition.If only two or three measuring points are available for a measurement, an average of the two or three measured values must be calculated.
[0108] Due to the routine nature of such pH measurements in the field, it is easy for the person skilled in the art to assess whether a possible measuring point is too dry.
[0109] The measurement can generally be performed with any measuring device that, in the opinion of a professional, is suitable for surface pH measurement. For example, the HI14142 or HI1413 electrodes from Hanna Instruments are suitable. The measuring device is calibrated according to the manufacturer's instructions before starting the measurement.
Claims
1. Incontinence article for absorption of bodily excretions, comprising an at least regionally liquid-permeable topsheet, a substantially liquid-impermeable backsheet, and an absorption body arranged between the topsheet and the backsheet, wherein the incontinence article between the topsheet and the backsheet comprises at least regionally a pH regulator, wherein the pH regulator comprises monosodium citrate or disodium citrate, wherein the pH regulator is particulate, wherein at least 50 percent by weight of the pH regulator has a particle size of 10 to 2000 µm.
2. Incontinence article according to Claim 1, wherein the pH regulator comprises trisodium citrate.
3. Incontinence article according to Claim 1, wherein the pH regulator consists of monosodium citrate.
4. Incontinence article according to Claim 1, wherein the pH regulator consists of disodium citrate.
5. Incontinence article according to one or more of Claims 1 to 4, wherein at least 50 percent by weight of the pH regulator has a particle size of 50 to 1200 pm, in particular of 80 to 800 µm.
6. Incontinence article according to one or more of Claims 1 to 5, wherein the amount of pH regulator is 10 to 100 g / m2, in particular 20 to 80 g / m2, further in particular 25 to 60 g / m2.
7. Incontinence article according to one or more of Claims 1 to 6, wherein the absorption body comprises at least one storage layer which comprises a superabsorbent polymer (SAP).
8. Incontinence article according to Claim 7, wherein the storage layer is substantially free of the pH regulator.
9. Incontinence article according to one or more of Claims 1 to 8, wherein the incontinence article comprises a liquid-acquisition layer which forms a layer of the absorption body that directly faces the topsheet.
10. Incontinence article according to Claim 9, wherein the pH regulator is positioned substantially between the liquid-acquisition layer and an absorption body layer that faces the backsheet.
11. Incontinence article according to one or more of Claims 1 to 10, wherein the incontinence article maintains a skin-friendly pH over at least two, in particular at least three, micturition events.
12. Incontinence article according to Claim 11, wherein the pH on a top side of the incontinence article that faces the skin is a value of 4.8-6.5, in particular 5.0-6.2, further in particular 5.2-6.0, further in particular 5.3-5.8, further in particular 5.4-5.6.