A therapeutic GEL body wash composition for incontinent care

Abstract

A therapeutic gel body wash composition for incontinent care is disclosed, comprising a mixture of deionized water, sodium PCA, glycerin, L-arginine, and a prebiotic deodorizing blend including yeast beta-glucan, glucosamine HC1, and amino acids. The composition further includes surfactants, a polyglyceryl emulsifier blend, and antimicrobial agents such as chlorhexidine digluconate, along with skin-conditioning botanical extracts. A comprehensive hygiene system is also provided, integrating the body wash with a barrier cream, cleansing wipes, laundry detergent, and incontinence pads, each embedded with active therapeutic ingredients to promote skin healing and odor neutralization. Additionally, a method of manufacturing the body wash is described, utilizing a multi-phase mixing process and pH adjustment to between 4.50 and 5.50 to ensure high solubility and stability of the therapeutic components.

Description

[0001] TITLE OF THE INVENTION

[0002] A THERAPEUTIC GEL BODY WASH COMPOSITION FOR INCONTINENT CARE RELATED APPLICATIONS

[0003] [1] This application claims priority to U.S. Provisional Patent Application Ser. No.

[0004] 63 / 779,294 filed March 28, 2025, now pending.

[0005] FIELD OF THE INVENTION

[0006] [2] This invention relates generally to a therapeutic cleansing and skin protection system for incontinent care. More particularly, the invention relates to a gel body wash composition featuring a prebiotic deodorizing blend, antimicrobial agents like chlorhexidine digluconate, and botanical extracts configured to neutralize odors and promote skin regeneration. The invention further relates to an integrated hygiene system comprising a body wash, barrier cream, cleansing wipes, laundry detergent, and incontinence pads, all embedded with active therapeutic ingredients to provide a multistage approach to preventing incontinence-associated dermatitis and managing the complications associated with incontinence.BACKGROUND OF THE INVENTION

[0007] [3] The present invention relates generally to the field of personal care and hygiene. More specifically, the invention relates to a therapeutic gel body wash and a comprehensive hygiene system specifically formulated for incontinent care, utilizing natural antimicrobial agents and prebiotic components to treat dermatitis and neutralize odors while promoting skin restoration.

[0008] [4] Incontinence is a widespread condition impacting millions of Americans across the entire lifespan, from infants and non-toileting children to those in postpartum recovery and the bed-ridden elderly. For the pediatric population, the constant presence of moisture and irritants makes infants uniquely susceptible to diaper dermatitis, a condition affecting upwards of 6% of the general population. Whether in a nursery or a long-term care facility, untreated dermatitis frequently escalates into painful skin breakdown, infections, or pressure ulcers. This persistent risk to skin integrity poses a severe threat to patient health and represents a significant burden on the healthcare system.

[0009] [5] Traditionally, the management of incontinence-related skin breakdown has relied on standard cleansing agents or heavy barrier creams. However, many existing products on the market are either insufficient in their antimicrobial properties or are formulated with harsh chemical surfactants and preservatives. These ingredients can further irritate compromised skin by stripping away natural lipids and exacerbating the inflammatory cycle of dermatitis. There is a notable scarcity of incontinent care productsthat effectively bridge the gap between gentle hygiene and active medical-grade skin restoration.

[0010] [6] Furthermore, odor management remains a persistent challenge in incontinent care. Conventional products often rely on heavy fragrances to mask unpleasant odors, which can lead to further skin sensitivities. There is a growing demand for multifunctional formulations that can neutralize odors at a molecular level while simultaneously delivering active moisturization and antimicrobial protection.

[0011] [7] Consequently, there is a need for a hygiene solution that utilizes natural antimicrobial and skin-restorative ingredients such as turmeric, cranberry, and specific prebiotic blends to promote the healing of damaged skin. Such a system would ideally provide a synergistic approach to care by combining cleansing, microbial inhibition, and the restoration of the skin’s natural barrier without the use of harsh and irritating ingredients.

[0012] RELEVANT PRIOR ART

[0013] [8] Chlorhexidine-digluconate (l,l'-hexamethylenebis[5-(4 chlorophenyl)biguanide] digluconate) was first described as a broad-spectrum antiseptic in the 1950s (see: Davies et al., British Journal of Pharmacology, Vol. 9, Iss. 2). It is widely recognized in the art for its efficacy against Gram-positive and Gram-negative bacteria. While commonly used in clinical skin preparations, traditional formulations often utilize aggressive cleansers or high alcohol content that can be severely drying or irritating to compromised skin. Similarly, Aloe barbadensis juice and Tocopheryl acetate (Vitamin E) are well-documented for their soothing and antioxidant properties,respectively, though their integration into high-stability, low-shear manufactured gel washes specifically for incontinent care remains a specialized and unaddressed field.

[0014] [9] The use of prebiotics in topical applications has been explored by various researchers to support the skin microbiome. Lactobacillus ferment and yeast-derived beta-glucans have been described as agents capable of enhancing the skin barrier and providing anti-inflammatory benefits (see: Nuebic et al., Journal of Cosmetic Science, Vol. 67, p. 115-123 (2016)). Furthermore, the role of amino acids such as L-arginine and Lysine HC1 in supporting skin protein synthesis and moisture retention is documented in dermatological literature (see: Wade et al., Amino Acids in Personal Care, Vol. 12, p. 45-58 (2014)). However, these documents are generally silent regarding a specific, synergistic "prebiotic deodorizing blend" configured specifically to neutralize urine-derived ammonia odors through biochemical intervention rather than the use of masking fragrances.

[0015]

[0010] The use of Curcuma longa (Turmeric) in topical treatments is a subject of extensive prior art, most notably for its wound-healing properties (see: U.S. Patent No.

[0016] 5,401,504 / Traditional filings frequently focus on turmeric powder or concentrated curcumin extracts standardized to high curcuminoid levels. However, these concentrated forms often present significant formulation challenges, including low water solubility, poor skin penetration, and objectionable yellow staining of the skin and clothing (see: US Patent No. 7,763,289). In contrast, Turmeric Hydrosol captures the cellular water and volatile aromatic molecules of the plant, containing unique water-soluble compounds like 1,8-cineole. While recent studies have identified that turmeric hydrosols can inhibit staphylococcal biofilm formation (see: Academia.edu, "Comparison of theEffects of Hydrosol Extracted from Turmeric," 2026), the prior art remains silent on the integration of turmeric hydrosol into a multi-phase manufacturing process designed to stabilize antimicrobial biguanides and prebiotic blends for the targeted treatment of incontinence-related dermatitis.

[0017]

[0011] U.S. Patent Application No. 2018 / 0125764 (SMITH) discloses various hygiene compositions containing botanical extracts like cranberry and turmeric for general skin health. However, this disclosure does not provide for a multi-phase manufacturing process involving a high-temperature Phase B slurry to ensure the full solubilization of crystalline thickeners like Polyquaternium- 10, nor does it describe an integrated hygiene system where these active components are embedded across detergents, wipes, and barrier creams to create a cumulative therapeutic effect for incontinent patients.

[0018]

[0012] To this end, the development of an integrated hygiene and skin-restoration system is disclosed. The system is designed to promote dermatological health by enhancing antimicrobial protection. This fosters the neutralization of urine odors, improves moisture retention, and aids in the healing of compromised skin. The system is further characterized by the following novel features: (1) a primary therapeutic gel body wash composition comprising a prebiotic deodorizing blend, natural antimicrobials, and botanical extracts configured to provide a restorative foundation for incontinent care; (2) a multi-phase manufacturing process configured to ensure a homogeneous, high-solubility mixture with a physiologically optimized pH; (3) a comprehensive hygiene assembly including a barrier cream, cleansing wipes, laundry detergent, and absorbent pads embedded with active therapeutic ingredients for coordinated skin treatment; and (4) the integration of yeast beta-glucan, chlorhexidinedi gluconate, and a polyglyceryl emulsifier blend to create a supportive environment for thriving skin and capable of neutralizing odors without masking scents while inhibiting pathogen growth.SUMMARY

[0019]

[0013] This disclosure describes an integrated hygiene and skin-restoration system designed to optimize incontinent care through a therapeutically coupled, multi-stage composition. The system is built upon a chemical foundation comprising a therapeutic gel body wash featuring a prebiotic deodorizing blend, natural antimicrobials, and botanical extracts. The system utilizes a precise concentration of deionized water and sodium PCA as a base and is equipped with a Phase B slurry comprising glycerin, L-arginine, and polyquaternium-10. Active ingredients attained through this formulation are processed by a multi-phase manufacturing method that modulates thermal and shear conditions to create a homogeneous and high-solubility mixture. This mixture maintains a physiologically optimized pH between 4.50 and 5.50 to ensure skin compatibility. The system selectively shifts between a first cleansing mode for pathogen inhibition and a second restorative mode for focused skin repair using barrier creams, wipes, and absorbent pads.

[0020]

[0014] It is an advantage of the present invention to provide a hygiene system featuring a therapeutic gel body wash composition including a prebiotic deodorizing blend of yeast beta-glucan and amino acids to provide a bioactive platform for neutralizing urine odors;

[0021]

[0015] It is an additional advantage of the present invention to provide a hygiene system including chlorhexidine digluconate as a natural antimicrobial active that allows the system to inhibit pathogen growth while simultaneously promoting skin regeneration;

[0022]

[0016] It is an additional advantage of the present invention to provide a hygiene system utilizing a polyglyceryl emulsifier blend featuring polyglyceryl-6 caprylate andpolyglyceryl-3 cocoate for simultaneous stabilization of botanical extracts and synthetic actives;

[0023]

[0017] It is an additional advantage of the present invention to provide a hygiene system wherein the body wash is manufactured via a multi-vessel process to provide a near-perfectly solubilized interface for polyquaternium-10 and L-arginine crystals;

[0024]

[0018] It is still an additional advantage of the present invention to provide a hygiene system featuring a dual-action barrier cream and cleansing wipe configuration integrated with active therapeutic ingredients to significantly reduce the risk of pressure ulcers on damaged skin;

[0025]

[0019] It is still an additional advantage of the present invention to provide a hygiene system wherein a low-shear stirring process, performed after cooling, synchronizes the integration of surfactants with botanical hydrosols to minimize bubble formation; and

[0020] It is still an additional advantage of the present invention to provide a hygiene system that enhances the utility of standard incontinence products by providing an induction-based delivery system for stabilized, long-term skin protection.

[0026]

[0021] Additional advantages and features of the present invention will become more apparent when considered in light of the following specification and drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0027]

[0022] The present embodiments are illustrated by way of the figures of the accompanying drawings, which may not necessarily be to scale, in which like references indicate similar elements, and in which:

[0028]

[0023] FIG. 1 is a flowchart illustrating the four-phase manufacturing process for the therapeutic gel body wash composition, detailing the separate preparation of the Phase B slurry and the thermal management thresholds;

[0029]

[0024] FIG. 2 is a perspective view of the integrated hygiene system for incontinent care, showing a kit-style layout comprising the therapeutic gel body wash, barrier cream, cleansing wipes, laundry detergent, and incontinence pad;

[0030]

[0025] FIG. 3 shows clinical photographs of localized areas of compromised skin typical of the conditions addressed by the prebiotic deodorizing blend of the present invention;

[0031]

[0026] FIG. 4 is a table illustrating the pH stability of the therapeutic gel body wash composition over a 30-day period under both ambient and accelerated temperature conditions;

[0032]

[0027] FIG. 5 is a table detailing the physical property specifications and quality control results for the therapeutic gel body wash, including pH, viscosity, and density at controlled temperature conditions;

[0033]

[0028] FIG. 6 is a table detailing the physical property specifications and quality control results for the therapeutic gel body wash, including pH, viscosity, and density at controlled temperature conditions;

[0029] FTG. 7 is a table detailing the chemical identity, concentration, and specific function of the minor components and the secondary preservative system of the therapeutic gel body wash.

[0034]

[0030] FIG. 8 is a comprehensive quantitative formulation table for a preferred embodiment of the therapeutic gel body wash, specifying Phase A through Phase D components;

[0035]

[0031] FIG. 9A is a table providing a first portion of a quantitative formulation for a preferred embodiment, specifying the ingredients for Phases A, B, and a portion of Phase C; and

[0036]

[0032] FIG. 9B is a table providing a second portion of the quantitative formulation of FIG. 9A, specifying the ingredients for the remainder of Phase C and Phase D, and further providing the total weight-per-weight concentration.DETAILED DESCRIPTION

[0037]

[0033] The present invention primarily relates to the use of a therapeutic gel body wash composition 12 of an integrated hygiene system 10 as defined herein for promoting dermatological health and skin restoration in incontinent care. The present invention further relates to a method of manufacturing 100 a therapeutic gel body wash composition 12 as well as to methods for maintaining an integrated hygiene system 10 and to particular skin care products including barrier creams 14, cleansing wipes 16, laundry detergents 18, and incontinence pads 20. Further aspects of the present invention will arise from the description below, in particular from the examples, as well as from the attached patent claims.

[0038] DEFINITIONS

[0039]

[0034] As used herein, the term “comprising” means various components can be conjointly employed in the therapeutic gel body wash 12 and integrated hygiene system 10 of the present invention. Accordingly, the term “comprising” encompasses the more restrictive terms “consisting essentially of’ and “consisting of.”

[0040]

[0035] As used herein, therapeutic gel body wash 12 means the primary aqueous cleansing composition of the integrated hygiene system 10 configured to provide antimicrobial action and skin restoration;

[0036] As used herein, prebiotic deodorizing blend 34 means a bioactive mixture comprising yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1 designed to neutralize odors by supporting beneficial skin microflora;

[0041]

[0037] As used herein, chi orhexi dine digluconate 38 means a cationic biguanide compound acting as an antimicrobial active 38 configured to inhibit pathogen growth and promote a sterile environment for skin regeneration;

[0042]

[0038] As used herein, polyglyceryl emulsifier blend 40 means a surfactant assembly comprising polyglyceryl-6 caprylate, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, and polyglyceryl-6 ricinoleate configured to stabilize the interaction between botanical hydrosols 42 and lipid components;

[0043]

[0039] As used herein, L-arginine 32 means a crystalline amino acid utilized within the composition 12 to support protein synthesis and enhance the solubility of the polyquaternium-1032 thickener;

[0044]

[0040] As used herein, Phase B slurry 32 means a pre-mixed intermediate composition of glycerin and polymers used during a method of manufacturing 100 to ensure a homogeneous, lump-free distribution of conditioning agents;

[0045]

[0041] As used herein, integrated hygiene system 10 refers to the integrated collection of the therapeutic gel body wash 12, a barrier cream 14, cleansing wipes 16, laundry detergent 18, and incontinence pads 20, each sharing common active therapeutic ingredients 22;

[0046]

[0042] As used herein, barrier cream 14 means a topical semi-solid formulation configured to provide a physical shield against moisture while delivering embedded active therapeutic ingredients 22 to a compromised dermis 24;

[0043] As used herein, low-shear stirring means a mixing process characterized by low velocity and minimal turbulence, specifically used during low-shear integration 150 to integrate the surfactant system 36 while minimizing the formation of air bubbles or foam;

[0047]

[0044] As used herein, dual-action system means the capability of the integrated hygiene system 10 components to operate bidirectionally to provide both mechanical cleansing of the skin and targeted biochemical healing of a compromised dermis 24;

[0048]

[0045] As used herein, botanical extracts 42 refer to plant-derived substances, including but not limited to aloe barbadensis juice, cranberry fruit extract, and turmeric hydrosol, serving as natural antioxidants and anti-inflammatories;

[0049]

[0046] As used herein, physiologically optimized pH means a controlled acidity level, preferably between 4.50 and 5.50 at 25 °C, maintained by a pH adjuster 46 to match the natural acid mantle of human skin;

[0050]

[0047] As used herein, neutralizing urine odor refers to the biochemical process of the prebiotic deodorizing blend 34 altering or capturing odoriferous molecules without the use of heavy masking fragrances;

[0051]

[0048] As used herein, embedded with means a functional state where active therapeutic ingredients 22 are physically incorporated into the substrate of a cleansing wipe 16, laundry detergent 18, or incontinence pad 20 for controlled release; and

[0052]

[0049] As used herein, configured to minimize pressure refers to the structural or chemical property of the integrated hygiene system 10 components to reduce friction and mechanical stress on a compromised dermis 24 to prevent the formation of pressure ulcers.Clinical Safety Testing of the Therapeutic Gel Body Wash Composition

[0050] The safety and hypoallergenic properties of the therapeutic gel body wash composition 12 were evaluated through a Repeated Insult Patch Test (RIPT) (Study No. C25-4367.01). The test material, identified as EllaCure Lot#: 076-2502-004, was prepared as a 10% dilution in distilled water and applied via a semi-occlusive patch to the upper back of fifty-six (56) human subjects to observe impacts on the compromised dermis 24.

[0053]

[0051] The composition tested included the aqueous foundation 30, Phase B slurry 32, prebiotic deodorizing blend 34, and antimicrobial active 38, along with associated botanical extracts 42 and a pH adjuster 46 to maintain a skin-neutral environment.

[0054] Table 1: Subject Demographics and Skin Classification Demographic Factor Study Population (n=57) Age Range 16 - 79 Years

[0055] Gender 12 Male; 45 Female

[0056] Fitzpatrick Photo Type I-II 10 Subjects

[0057] Fitzpatrick Photo Type III-IV 38 Subjects

[0058] Fitzpatrick Photo Type V-VI 9 Subjects

[0059]

[0060]

[0052] As summarized in Table 1 above, the subject pool represented a broad demographic range, including males and females aged 16 to 79, with skin types ranging from Fitzpatrick Photo Type I to VI. This diverse demographic ensures the composition’s safety for various skin sensitivities across the lifespan. Crucially, the finalstudy results were reviewed and signed by both a Board-Certified Dermatologist and a Board-Certified Pediatrician, validating the therapeutic gel body wash composition 12 for use on infants, postpartum patients, and the elderly.

[0061]

[0053] During the Induction Phase, nine (9) consecutive applications of the composition resulted in zero (0) instances of erythema or dermal sequelae. Following a rest period, the Challenge Phase was conducted on a previously untreated "virgin" site. As shown in Table 2 below, 100% of the subjects who completed the study (n==56) exhibited a score of "0," indicating no visible skin change. The study concluded that the composition is a non-primary irritant and non-primary sensitizer, confirming its clinical suitability for the sensitive skin of incontinent patients of all ages.

[0062] Table 2: Clinical Response Data (RIPT)

[0063] Test Phase Number of Scoring Results (0-4 Clinical Subjects Scale) Observations Induction (9 Apps) 56 0 (No reaction) No irritation observed Rest Period 56 N / A No latent reactions Challenge (Virgin 56 0 (No reaction) No sensitization

[0064]

[0065] Site) observed Conclusion: 100% of completed subjects showed no reaction. The composition is clinically confirmed to be non-sensitizing and hypoallergenic.

[0066] Clinical Scope and Patient Demographics

[0067]

[0054] The present invention is specifically configured to address the complex dermatological needs of a diverse patient population impacted by incontinence. It is estimated that millions of Americans experience incontinence, ranging from temporary conditions such as postpartum recovery following the birth of a child to permanent and chronic conditions affecting bed-ridden elderly individuals.

[0055] A critical clinical challenge in this population is the development of incontinence-associated dermatitis (IAD) on a compromised dermis 24. Current data indicates that as low as 6% to significantly higher percentages of incontinent individuals are impacted by dermatitis. In institutional settings, such as nursing homes or long-term care facilities, untreated IAD frequently progresses into more severe pathologies, including hyperkeratotic nodules, lichenified tissue, and pressure ulcers (bedsores). The present invention provides an integrated hygiene system 10 designed to interrupt this progression by maintaining skin integrity through targeted biochemical intervention using active therapeutic ingredients 22.

[0068] Technical Problem and Integrated Solution

[0069]

[0056] The development of the present invention arose from an identified gap in the consumer and clinical markets for incontinent care. Conventional products often fail to address the "stigmatizing odors" and the proliferation of bacteria housed in urine, which are the primary drivers of both skin breakdown and patient social withdrawal. Many existing cleansers are formulated with harsh surfactants that strip the skin's natural barrier, or they rely on heavy synthetic fragrances to mask odors without neutralizing the underlying ammonia and bacterial byproducts.

[0070]

[0057] To solve these issues, the present invention provides a multifunctional integrated hygiene system 10 that is simultaneously antimicrobial, deodorant, and skinconditioning. By integrating an antimicrobial active 38 like chlorhexidine digluconate 38 with a prebiotic deodorizing blend 34, the integrated hygiene system 10 effectivelyeliminates odor-causing bacteria while promoting the growth of beneficial skin microflora.

[0071]

[0058] Furthermore, the inclusion of botanical extracts 42, such as turmeric hydrosol 42 and cranberry fruit extract, provides active skin-conditioning properties that facilitate the restoration of a compromised dermis 24. Unlike standard cleansers, this integrated hygiene system 10 is configured to neutralize the chemical environment created by urine exposure, thereby preventing the initial onset of dermatitis and reducing the risk of secondary infections and bedsores. This "dual-action" approach of cleansing the skin while simultaneously delivering active therapeutic ingredients 22 serves as a comprehensive solution for maintaining the health and dignity of incontinent individuals.

[0072] Alternative Embodiments and Concentration Ranges

[0073]

[0059] While the exemplary formulation of the therapeutic gel body wash 12 provides an optimized balance of cleansing and restoration, it should be understood that the concentrations of the active therapeutic ingredients 22 may be adjusted based on the specific clinical needs of the patient population. In a preferred embodiment, the antimicrobial active 38 (chlorhexidine digluconate 38) is present at a concentration of approximately 4.00% WAV. However, for maintenance-level care, the concentration may be reduced to as low as 0.5% WAV. Conversely, for intensive clinical applications targeting severe pathogen growth in institutional settings, the concentration may be scaled up to 10.0% WAV without departing from the spirit of the invention.

[0060] While the prebiotic deodorizing blend 34 comprising yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1 is preferably present at 1.50% WAV, alternative embodiments may utilize a range from 0.1% to 5.0% WAV. Furthermore, while equal parts by weight of these six components are preferred, the ratio may be adjusted to emphasize specific amino acids, such as L-arginine 32 or lysine HC1, to enhance skin-protein synthesis in a compromised dermis 24 (such as severely lichenified tissue). Additionally, the botanical extracts 42 (turmeric hydrosol 42 and cranberry fruit extract 42) are ideally utilized at 0.50% WAV each; however, these botanical extracts 42 may effectively function within a broader range of 0.01% to 3.0% WAV.

[0074] Functional Substitutes and Ingredient Versatility

[0075]

[0061] The present invention primarily relates to the use of a therapeutic gel body wash composition 12 of an integrated hygiene system 10 as defined herein for promoting dermatological health and skin restoration in incontinent care. The present invention further relates to a method of manufacturing 100 a therapeutic gel body wash composition 12 as well as to methods for maintaining an integrated hygiene system 10 and to particular skin care products including barrier creams 14, cleansing wipes 16, laundry detergents 18, and incontinence pads 20.

[0076]

[0062] As used herein, the term “comprising” means various components can be conjointly employed in the therapeutic gel body wash 12 and integrated hygiene system 10 of the present invention. Accordingly, the term “comprising” encompasses the more restrictive terms “consisting essentially of’ and “consisting of’.

[0063] As used herein, therapeutic gel body wash 12 means the primary aqueous cleansing composition of the integrated hygiene system 10 configured to provide antimicrobial action and skin restoration.

[0077] Prebiotic Deodorizing Blend and Functional Equivalents

[0078]

[0064] The prebiotic deodorizing blend of the present invention is specifically configured to neutralize urine-derived ammonia and volatile organic compounds through biochemical intervention rather than simple masking. While in one preferred embodiment the blend consists of equal parts by weight of yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1, it should be understood that the ratio of these components may be adjusted to target specific dermatological needs. For instance, the concentration of yeast beta-glucan may be increased to prioritize antiinflammatory response in active dermatitis, or the concentration of lysine HC1 may be increased to facilitate collagen synthesis in compromised tissue.

[0079]

[0065] One skilled in the art will recognize that several components of the blend may be substituted with functionally equivalent prebiotics or amino acids. Yeast beta-glucan may be partially or fully substituted with other polysaccharides such as inulin, alphaglucan oligosaccharide, or oat-derived beta-glucan. Similarly, the amino acids glutamine and lysine HC1 may be replaced or supplemented with other skin-conditioning amino acids including arginine, glycine, or proline. Furthermore, while glucosamine HC1 is a preferred aminosugar for its skin-repair properties, it may be substituted with N-acetyl glucosamine or chondroitin sulfate to achieve comparable restorative effects within the deodorizing matrix.Antimicrobial Active and Preservation Systems

[0080]

[0066] The prebiotic deodorizing blend 34 of the present invention is specifically configured to neutralize urine-derived ammonia and volatile organic compounds through biochemical intervention rather than simple masking. While in one preferred embodiment the prebiotic deodorizing blend 34 consists of equal parts by weight of yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1, it should be understood that the ratio of these components may be adjusted to target specific dermatological needs. For instance, the concentration of yeast beta-glucan may be increased to prioritize anti-inflammatory response in active dermatitis, or the concentration of lysine HC1 may be increased to facilitate collagen synthesis in a compromised dermis 24.

[0081]

[0067] One skilled in the art will recognize that several components of the prebiotic deodorizing blend 34 may be substituted with functionally equivalent prebiotics or amino acids. Yeast beta-glucan may be partially or fully substituted with other polysaccharides such as inulin, alpha-glucan oligosaccharide, or oat-derived betaglucan. Similarly, the amino acids glutamine and lysine HC1 may be replaced or supplemented with other skin-conditioning amino acids including L-arginine 32, glycine, or proline. Furthermore, while glucosamine HC1 is a preferred aminosugar for its skin-repair properties, it may be substituted with N-acetyl glucosamine or chondroitin sulfate to achieve comparable restorative effects within the deodorizing matrix.Hydrogen Ion Concentration and pH Optimization

[0082]

[0068] The therapeutic gel body wash composition 12 is specifically formulated to maintain a physiologically optimized pH between 4.50 and 5.50 at 25 °C, which is critical for preserving the natural acid mantle of the skin and preventing the enzymatic breakdown often caused by prolonged exposure to urine. While a range of 4.50 to 5.50 is ideal for most incontinent care applications, the therapeutic gel body wash composition 12 remains effective and stable within a broader pH window of 4.0 to 6.5. This controlled acidity not only ensures skin compatibility but also stabilizes the bioactivity of the antimicrobial active 38 (chi orhexi dine digluconate 38) and botanical extracts 42 (botanical hydrosols 42).

[0083] pH Adjustments and Buffering Agents

[0084]

[0069] To achieve and maintain the target pH, the therapeutic gel body wash composition 12 utilizes citric acid 46 as a primary pH adjuster 46. Citric acid 46 is preferred for its high solubility in aqueous gel systems and its ability to provide a mild buffering effect. However, one skilled in the art will understand that other organic or inorganic acids may be utilized for pH regulation, including lactic acid, malic acid, tartaric acid, or phosphoric acid. In embodiments where the initial pH of the mixture is too low, alkaline adjusters such as sodium hydroxide, triethanolamine, or L-arginine 32 may be employed to raise the pH to the desired specification. The concentration of the pH adjuster 46 is typically provided in an amount quantum satis (q.s.) to reach the target range, ensuring the final therapeutic gel body wash composition 12 remains non-irritating and chemically stable throughout its shelflife.Hygiene System for Incontinent Care

[0085]

[0070] Referring to the kit-style layout of FIG. 2, the present invention provides a comprehensive integrated hygiene system 10 specifically configured for the multi-stage management of incontinence-induced dermatitis. The integrated hygiene system 10 comprises a therapeutic gel body wash 12, a barrier cream 14, cleansing wipes 16, a laundry detergent 18, and an incontinence pad 20. A primary novel feature of the integrated hygiene system 10 is the embedding of active therapeutic ingredients 22 such as the prebiotic deodorizing blend 34 or chlorhexidine digluconate 38 across each component to provide cumulative skin protection.

[0086]

[0071] While the preferred embodiment utilizes these five specific components, one skilled in the art will recognize that the integrated hygiene system 10 may be scaled to include additional or alternative hygiene products. For instance, the integrated hygiene system 10 may further comprise a therapeutic skin toner, a post-cleansing moisturizing lotion, or a localized antimicrobial spray. In alternative embodiments, the laundry detergent 18 may be substituted with a textile-safe antimicrobial spray for use on non-washable medical upholstery, and the incontinence pad 20 may be substituted by or used in conjunction with therapeutic bed linens or medical-grade underpads containing the same active therapeutic ingredients 22.

[0087] Quantitative Composition of the Therapeutic Gel Body Wash

[0088]

[0072] The therapeutic gel body wash 12 is formulated as an aqueous gel comprising an aqueous foundation 30 (deionized water and sodium PCA) and glycerin to provide highhumectant capacity. The inclusion of L-arginine and polyquaternium-10 (as part of the Phase B slurry 32) facilitates the formation of a protective, conditioning fdm over compromised dermis 24. As detailed in the comprehensive formulation table of FIGS.

[0089] 6, 9A and 9B, the composition further integrates a surfactant system 36 of olefin sulfonate, betaine, and glucoside to provide gentle cleansing without disrupting the skin’s lipid barrier.

[0090]

[0073] Although specific weight percentages are provided in the exemplary embodiments, the concentration of active therapeutic ingredients 22, such as the botanical extracts 42 (turmeric hydrosol and cranberry fruit extract), may range from 0.01 % to 5.0 % WAV. Furthermore, while the polyglyceryl emulsifier blend 40 is preferred for its ability to stabilize the botanical lipid components, it may be partially or fully substituted with other PEG-free, non-ionic emulsifiers, such as sorbitan stearate or cetearyl glucoside, to maintain the structural integrity of the gel matrix under various thermal conditions.

[0091] Method of Manufacturing and Thermal Management

[0092]

[0074] The manufacturing process follows a method of manufacturing 100 as illustrated in the flowchart of FIG. 1. The method begins with an initial mixing step 110 involving the addition of an aqueous foundation 30 (deionized water and sodium PCA) to a main tank, followed by a slurry preparation step 120 in a separate vessel. This Phase B slurry 32, comprising glycerin, L-arginine, polyquaternium-10, and the prebiotic deodorizing blend 34, is critical for ensuring that the crystalline gelling agents are uniformly distributed before being added to the main tank.

[0075] As specified in the manufacturing method, the Phase B slurry 32 is added to the main tank and subjected to a heating and solubilization step 130 to approximately 65°C. This heating is continued specifically until the polyquatemium-10 and L-arginine crystals are fully solubilized. This step is essential for achieving the clear, homogeneous viscosity of the final gel. Following solubilization, the mixture is subjected to a cooling step 140 to below 45°C before the addition of temperature-sensitive botanical extracts 42 and a surfactant system 36 via a low-shear integration step 150. One skilled in the art will understand that while 65°C is an ideal target, the temperature may range between 55°C and 75°C depending on the specific grade of polyquaternium-10 utilized.

[0093]

[0076] Although specific weight percentages are provided in the exemplary embodiments, the concentration of active therapeutic ingredients 22, such as the botanical extracts 42 (turmeric hydrosol and cranberry fruit extract), may range from 0.01 % to 5.0 % W / W. Furthermore, while the polyglyceryl emulsifier blend 40 is preferred for its ability to stabilize the botanical lipid components, it may be partially or fully substituted with other PEG-free, non-ionic emulsifiers, such as sorbitan stearate or cetearyl glucoside, to maintain the structural integrity of the gel matrix under various thermal conditions.

[0094] Low-Shear Stirring and Consistency Optimization

[0095]

[0077] Following the cooling phase, the remaining ingredients including the surfactants, botanical hydrosols, and preservatives are added one by one to the main tank. A critical step in this process is the use of low-shear stirring, which is characterized by a mixing velocity sufficient to ensure homogeneity without inducing excessive turbulence. Thismethod is specifically configured to minimize bubble formation and aeration, which could otherwise compromise the viscosity and clarity of the gel. In alternative embodiments, air-release may be utilized in conjunction with low-shear stirring to further enhance the transparency and stability of the final product.

[0096] Prebiotic Odor Neutralization and Scents

[0097]

[0078] The prebiotic deodorizing blend 34 is a bioactive formulation specifically configured to neutralize urine-derived odors through molecular intervention rather than traditional masking. In the context of the present invention, "masking scents" refers to the use of heavy, synthetic fragrances that merely cover malodors without addressing the underlying chemical cause. By utilizing a blend of yeast beta-glucan and specific amino acids (as part of the active therapeutic ingredients 22), the present invention neutralizes odoriferous ammonia and volatile organic compounds while supporting beneficial skin microflora. This ensures that the skin remains biologically clean and free of "stigmatizing odors" without the need for artificial perfumes that may irritate the sensitive, excoriated tissue of the compromised dermis 24 depicted in the clinical photographs of FIG. 3.Table 3: Antimicrobial Effectiveness (MIC Values)

[0098] Pathogen Type Representative MIC (Formula Control Species % W / W) (Placebo) Gram-Positive Staphylococcus 0.15 No Inhibition %

[0099] Bacteria aureus

[0100] Gram-Negative Escherichia coli 0.25 No Inhibition %

[0101] Bacteria

[0102] Yeast / Fungi Candida albicans 0.50 No Inhibition %

[0103] Spore-forming Clostridium difficile 1.00 No Inhibition %

[0104] Bacteria

[0105]

[0106]

[0079] As shown in Table 3 above, the present invention demonstrates significant microbial reduction at concentrations significantly lower than the preferred 4.00% WAV formulation. This ensures a broad safety margin for clinical use.Table 4: Odor Neutralization Efficiency

[0107] Test Group Odor Residual Perceived Odor Mechanism Ammonia (ppm)

[0108] Present Bio<5 Clean / Neutral ppm

[0109] Invention Neutralization

[0110] Fragranced Masking >45 Heavy

[0111] ppm

[0112] Control Ammonia / Perfume Untreated None 120 Pungent Ammonia PPm

[0113] Sample

[0114]

[0115]

[0080] To demonstrate the "neutralizing" capability of the prebiotic blend, an ammonia challenge test (shown in Table 4 above) was conducted comparing the present invention to a standard fragranced cleanser.

[0116] Pathogen Inhibition and Skin Regeneration

[0117]

[0081] The inclusion of antimicrobial active 38 (chi orhexi dine di gluconate) provides a high-potency active configured to inhibit pathogen growth and promote skin regeneration. As used herein, "inhibiting pathogen growth" refers to the reduction or total elimination of bacterial and fungal proliferation, particularly species like Staphylococcus aureus or Candida albicans, which are common in incontinence-associated dermatitis. By maintaining a sterile environment, the composition allows the underlying dermal layers of the compromised dermis 24 to undergo "skin regeneration," which refers to the biochemical process of re-epithelialization and the restoration of theskin’s natural barrier. This restorative effect is further supported by the active therapeutic ingredients 22, specifically the botanical extracts 42 (turmeric hydrosol), which provide water-soluble anti-inflammatories to soothe the lichenified tissue shown in FIG. 3.

[0118] Dual-Action System and Pressure Minimization

[0119]

[0082] The integrated hygiene system 10 is configured as a dual-action system for gentle cleansing and targeted skin healing. This "dual-action" refers to the capability of the components, such as the barrier cream 14 and cleansing wipes 16, to provide both mechanical removal of irritants and the biochemical delivery of active therapeutic ingredients 22. Alternative to this dual-action configuration, the system 10 may be utilized as a "triple-action" system by incorporating a secondary antiseptic step or a dedicated moisture-wicking layer within the incontinence pad 20.

[0120]

[0083] Furthermore, the system 10 is configured to minimize pressure on compromised dermis 24 and reduce the risk of pressure ulcers. This is achieved through the use of high-lubricity surfactant systems 36 and conditioning agents in the therapeutic gel body wash 12, which reduce friction during the cleansing of the compromised dermis 24 shown in FIG. 3. In the case of the incontinence pad 20, the system 10 minimizes pressure by utilizing advanced absorbent cores that quickly wick away moisture, thereby preventing the skin maceration that typically precedes the formation of a bedsore. By integrating these physical and chemical protections, the system 10 ensures the long-term health and comfort of bed-ridden or postpartum individuals.

[0084] Therefore, in a preferred embodiment, a therapeutic gel body wash composition 12 for incontinent care comprises an aqueous foundation 30 (deionized water and sodium PC A), a Phase B slurry 32 (glycerin, L-arginine, and polyquaternium-10), and a prebiotic deodorizing blend 34. The prebiotic deodorizing blend 34 comprises yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1. The therapeutic gel body wash composition 12 further comprises a surfactant system 36 (sodium C14-C16 olefin sulfonate, cocamidopropyl betaine, and caprylyl / capryl glucoside), glyceryl oleate, and an antimicrobial active 38 (chlorhexidine digluconate). The composition also includes a polyglyceryl emulsifier blend 40 comprising polyglyceryl-6 caprylate, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, and polyglyceryl-6 ricinoleate. Additionally, the composition includes active therapeutic ingredients 22 such as polyquaternium-7, botanical extracts 42 (aloe barbadensis juice, cranberry fruit extract, and turmeric hydrosol), lactobacillus ferment, PEG shea butter, tocopheryl acetate, and a preservative system 44 (phenoxyethanol and ethylhexylglycerin).

[0121]

[0085] In one aspect of the therapeutic gel body wash composition 12, the prebiotic deodorizing blend 34 consists of equal parts by weight of yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1. In another aspect, the chlorhexidine digluconate is present as an antimicrobial active 38. The therapeutic gel body wash composition 12 has a pH between 4.50 and 5.50 at 25 °C and may further comprise a pH adjuster 46 (citric acid). The prebiotic deodorizing blend 34 is a bioactive formulation configured to neutralize urine odor without masking scents. Furthermore,the chlorhexidine digluconate is a natural antimicrobial configured to inhibit pathogen growth and promote skin regeneration on a compromised dermis 24.

[0122]

[0086] As illustrated in FIG. 2 and FIG. 8, an integrated hygiene system 10 for incontinent care comprises a therapeutic gel body wash composition 12, a barrier cream 14 embedded with one or more active therapeutic ingredients 22, and cleansing wipes 16 embedded with one or more of said active therapeutic ingredients 22. The hygiene system 10 further comprises a laundry detergent 18 embedded with one or more of said active therapeutic ingredients 22 and an incontinence pad 20 embedded with one or more of said active therapeutic ingredients 22. In the hygiene system 10, the barrier cream 14 and cleansing wipes 16 are configured as a dual-action system for gentle cleansing and targeted skin healing. The system 10 is further configured to minimize pressure on damaged skin areas and reduce the risk of pressure ulcers on a compromised dermis 24.

[0123]

[0087] As illustrated in FIG. 1, a method of manufacturing 100 a therapeutic gel body wash composition 12 for incontinent care comprises several steps. The method begins with an initial mixing step 110 of adding the following ingredients of an aqueous foundation 30 to a main tank one by one and allowing the mixture to become homogeneous between each addition: deionized water and sodium PCA. In a separate vessel, a slurry preparation step 120 involves adding the following ingredients and stirring until a homogenous Phase B slurry 32 has formed: glycerin, L-arginine, polyquaternium-10, and a prebiotic deodorizing blend 34 comprising yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1.

[0088] The method proceeds to a heating and solubilization step 130 by adding this Phase B slurry 32 to the main tank and heating to 65 °C or until any polyquatemium- 10 or L-arginine crystals have solubilized. The heating is continued until the polyquatemium- 10 and L-arginine crystals are fully solubilized. After heating, a cooling step 140 is performed by removing main tank contents from heat and allowing it to cool to below 45 °C.

[0124]

[0089] The method continues with a low-shear integration step 150 by adding the following ingredients to the main tank one by one while stirring at low shear, allowing the mixture to become homogeneous between each addition: a surfactant system 36 (sodium C14-C16 olefin sulfonate, cocamidopropyl betaine, and caprylyl / capryl glucoside), glyceryl oleate, antimicrobial active 38 (chlorhexidine digluconate), a polyglyceryl emulsifier blend 40 comprising polyglyceiyl-6 caprylate, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, and polyglyceryl-6 ricinoleate, polyquaternium-7, and botanical extracts 42 (aloe barbadensis juice, lactobacillus ferment, cranberry fruit extract, and turmeric hydrosol), PEG-50 shea butter, tocopheryl acetate, and a preservative system 44 (phenoxyethanol and ethylhexylglycerin). These additions to the main tank following cooling are performed with low-shear stirring to minimize bubble formation. Finally, a pH adjustment and final standardization step 160 is performed by adjusting the pH to between 4.50 and 5.50 by addition of a pH adjuster 46 (citric acid).

[0125]

[0090] A number of illustrative embodiments have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spiritand scope of the various embodiments presented herein. Accordingly, other embodiments are within the scope of the following claims.

Claims

CLAIMSWhat is claimed is:

1. A therapeutic gel body wash composition for incontinent care comprising:deionized water, sodium PC A, glycerin, L-arginine, polyquaternium-10, a prebiotic deodorizing blend comprising yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1, sodium C14-C16 olefin sulfonate, cocamidopropyl betaine, caprylyl / capryl glucoside, glyceryl oleate, chlorhexidine digluconate, a polyglyceryl emulsifier blend comprising polyglyceryl-6 caprylate, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, and polyglyceryl-6 ricinoleate, polyquaternium-7, aloe barbadensis juice, lactobacillus ferment, cranberry fruit extract, turmeric hydrosol, PEG-50 shea butter, tocopheryl acetate, phenoxyethanol, and ethylhexylglycerin.

2. The therapeutic gel body wash composition of claim 1, wherein the prebiotic deodorizing blend consists of equal parts by weight of yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1.

3. The therapeutic gel body wash composition of claim 1, wherein the chlorhexidine digluconate is present as an antimicrobial active.

4. The therapeutic gel body wash composition of claim 1 , wherein the composition has a pH between 4.50 and 5.50 at 25 °C.

5. The therapeutic gel body wash composition of claim 1, wherein the composition further comprises citric acid for adjusting pH.

6. A hygiene system for incontinent care comprising:a therapeutic gel body wash composition;a barrier cream embedded with one or more active therapeutic ingredients; cleansing wipes embedded with one or more of said active therapeutic ingredients;a laundry detergent embedded with one or more of said active therapeutic ingredients; andan incontinence pad embedded with one or more of said active therapeutic ingredients.

7. The hygiene system for incontinent care of claim 6, wherein the therapeutic gel body wash comprises:deionized water, sodium PC A, glycerin, L-arginine, polyquaternium-10, a prebiotic deodorizing blend comprising yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1, sodium C14-C16 olefin sulfonate, cocamidopropyl betaine, caprylyl / capryl glucoside, glyceryl oleate, chlorhexidine digluconate, a polyglyceryl emulsifier blend comprising polyglyceryl-6 caprylate, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, and polyglyceryl-6 ricinoleate, polyquaternium-7, aloe barbaden sis juice, lactobacillus ferment, cranberry fruit extract, turmeric hydrosol, PEG-50 shea butter, tocopheryl acetate, phenoxyethanol, and ethylhexylglycerin.A method of manufacturing a therapeutic gel body wash composition for incontinent care, the method comprising the steps of:adding the following ingredients to a main tank one by one and allowing the mixture to become homogeneous between each addition: deionized water and sodium PCA;in a separate vessel, adding the following ingredients and stirring until a homogenous slurry has formed: glycerin, L-arginine, polyquaternium-10, and a prebiotic deodorizing blend comprising yeast beta-glucan, PCA, glucosamine HC1, betaine, glutamine, and lysine HC1, adding this Phase B slurry to the main tank and heating to 65 °C or until any polyquatemium-10 or L-arginine crystals have solubilized;removing main tank contents from heat and allowing it to cool to below 45 °C, adding the following ingredients to the main tank one by one while stirring at low shear, allowing the mixture to become homogeneous between each addition: sodium C14-C16 olefin sulfonate, cocamidopropyl betaine, caprylyl / capryl glucoside, glyceryl oleate, chlorhexidine digluconate, a polyglyceryl emulsifier blend comprising polyglyceryl-6 caprylate, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, and polyglyceryl-6 ricinoleate, polyquaternium-7, aloe barbadensis juice, lactobacillus ferment, cranberry fruit extract, turmeric hydrosol, PEG-50shea butter, tocopheryl acetate, phenoxyethanol, and ethylhexylglycerin; andsadjusting the pH to between 4.50 and 5.50 by addition of citric acid.

9. The method of claim 8, wherein the heating is continued until the polyquaternium-10 and L-arginine crystals are fully solubilized.

10. The method of claim 8, wherein the additions to the main tank following cooling are performed with low-shear stirring to minimize bubble formation.

11. The composition of claim 1, wherein the prebiotic deodorizing blend is a bioactive formulation configured to neutralize urine odor without masking scents.

12. The composition of claim 1, wherein the chlorhexidine digluconate is a natural antimicrobial configured to inhibit pathogen growth and promote skin regeneration13. The hygiene system of claim 6, wherein the barrier cream and cleansing wipes are configured as a dual-action system for gentle cleansing and targeted skin healing.

14. The hygiene system of claim 6, wherein the system is configured to minimize pressure on damaged skin areas and reduce the risk of pressure ulcers.

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