Smart diaper for fertility and gender orientation

Abstract

The invention consists of a diaper adapted to keep genitalia far from the body and exposed to the ambient temperature (to a certain degree), thereby allowing the genitalia to be cooled by ambient air and / or by PCM. It is postulated that this may have beneficial effects on the future sexual and gender development of infants and on the present reproductive health and function of adults in both sexes. This a new configuration is attended to prevent or to minimized human organism from fecal bacterial contamination.

Description

[0001] Smart Diaper for fertility and gender orientation

[0002] Field of the Invention

[0003] The present invention relates generally to the field of diapers, and more specifically application of new configured patented Smart Diaper for babies and adults.

[0004] Background of the Invention

[0005] The plastic (and usually waterproof) outer layers of a modem disposable diaper are impermeable and insulating with regards to heat and vapor exchange and are fitted tight to the body. These diapers therefore retain the body heat generated by the wearer, as well as the heat released by bodily fluids excreted. In addition to heat generated inside the diaper, bodily excretions induce inflammatory processes and infections due to fecal bacterial flora contamination through penetration into the genital tract in both sexes. This may have immediate negative effects on the health of babies and adults (including geriatric patients). In babies who have worn such diapers, effects upon the reproductive potential of the individual may occur after puberty, due to the damage from prolonged heating of the scrotum and acute or chronic inflammatory damages in the developing reproductive tissues (testicles, ovaries, oviduct and endometrium). In the natural situation, the scrotum temperature is certainly nearly 3-4 degrees lower than that of the body’s core, and this lower temperature is obligatory for normal sperm cell production after puberty, and possibly, for normal development (proliferation and differentiation) of fertility capacity (germ cells at different stages of development) at the period of neonates, infancy and toddlers. There is scientific evidence that suggests that increased temperature of the scrotum during neonate period and infancy may cause permanent damage to male fertility in adult age (Hadziselimovic and Herzog, The importance of both an early orchidopexy and germ cell maturation for fertility. Lancet 2001; 358:1156-1157). Possible results of this situation may include cryptorchidism and further reduced fertility due to the prolonged inner heat of testicles. In the female, it is speculated that heat exchange is also relevant for normal ovarian function (shown in bovine model; Morita et al., Establishment of long-term chronic recording technique of in vivo ovarian parenchymal temperature in Japanese Black cows. J. Reprod. Develop. 2020; 66:271-275).

[0006] Another aspect of a novel configuration of diaper (Smart Diaper) is not only to protect reproductive potential and function of babies after puberty, but also to save normal development of baby’s brain. It is a well known phenomenon that the brain is develops all the time from birth (or rather from embryo period) until its maturation at puberty that leads to the beginning of start of fertility. The newborn brain weight is 0.35 kg, which is doubles to 0.7 kg (100%) at age of 6 months, then elevates to 1 kg (additional 30%) at age of 1 year old, then elevates to 1.2 kg (additional 20%) at age 2 years old and to 1.3 kg (additional 9%) at age 3 years old, without any additional weight elevation until puberty and adulthood. At this early stage of brain development, at the first year of life, the brain is veiy sensitive to hormonal influence in processes of sexual orientation. The brain develops as male brain in boys and female brain in girls under influence of the sex-hormonal surge at the first half of life year named mini puberty (Backer and Hesse, Mini puberty: why does it happen? Horm. Res. Paediatr. 2020; 93:76-84). This sex-hormonal surge starts immediately after delivery and disappears after the first 6 months of life until a new surge at puberty. In fact, the brain’s first sexual orientation (both for male and female) starts at embiyo stage, then the second one at first 6 months of life and the last one at puberty. It is postulated that humans have a critical period of early post-natal development during which over- or underexposure to sex hormones either masculinizes or feminizes the brain. The wearing of conventional diapers (elevated genital temperature) during this critical time for the development of the brain may have long term consequences for normal or abnormal hormonal secretion and sex-orientation of the brain. Summary of the Invention

[0007] Normal modem diapers are generally made using air- and moisture-tight construction that prevents free passage of fluids between the body and the ambient. Such diapers are often worn nearly non-stop, during day and night, only being removed for diaper changes. It has been measured that such diapers maintain the infant genitalia at temperatures at least several degrees higher than those found in infants not using such diapers.

[0008] We introduce a novel type of diaper, a “Smart Diaper” that facilitates more natural conditions for neonate and infant development. These improved conditions are postulated to be conducive to natural processes of development such as hormonal secretion, sex-orientation of developing brain and further reproductive health during this extremely important time frame for babies. We believe that the “Smart Diaper” may prevent unwanted changes in further reproductive functions, and sex-orientation of the brain.

[0009] The diaper is adapted to keep the genitalia exposed to the ambient temperature (to a certain degree), thereby allowing genitalia to be aerated and hence cooled. This is a more natural state, in which it is presumed the human species evolved, and is anticipated to be conducive to normal sexual and gender development of the infant. Furthermore, the design attend to prevent contact between genitalia and feces, preventing any possible negative effect of fecal bacteria populations on health conditions in babies as well as in adults.

[0010] This invention is adapted to keep the genitalia at a distance from fecal contamination. Such contamination may be involved in morbidity and even mortality (for adult users and geriatric ages) due to bacterial and / or fungal growth and induced inflammation. This invention prevents a contact of urine with skin. Thus, the invention prevents the irritation and discomfort of prolonged contact between urine / feces and skin, and minimizes human organism from fecal bacterial contamination. Most hygiene care products such as wipes and diapers contain complexes mixtures of harmful chemicals such as phthalates for example. The material of the diaper will preferably include nature-friendly constituents. Brief Description of the Drawings

[0011] Embodiments and features of the present invention are described herein in conjunction with the following drawings:

[0012] Fig. 1A shows the inner diaper (section) separated from outer diaper (section) of the diaper unit of the invention.

[0013] Fig. IB shows the inner diaper (section) connected to outer diaper (section) of the diaper unit of the invention.

[0014] Fig. 2 shows the side cut of the invention.

[0015] Fig. 3A shows steps of male wearing the invented diaper with penis and scrotum exposed and enclosed in a pocket between inner part and outer part of invention.

[0016] Fig. 3B shows steps of female wearing the invented diaper with vulva exposed and enclosed in a pocket between inner part and outer part of invention.

[0017] Figs. 4A,B shows a variant of invention, when invention is used as two divided and separated parts of inner diaper from outer diaper.

[0018] Fig. 5 shows a main variant of invention with inner part (inner diaper) connected to outer part of diaper (outer diaper) at the posterior (back) region, forming a pocket that totally separates feces from the urine, and prevent the mixture of urine with feces.

[0019] Figs. 6A,B shows an optional variant of invention with possible connection between inner and outer diapers on its center bottom (line). In this type of the version, all parts are free and connected all together at one center bottom (line).

[0020] Detailed Description of Preferred Embodiments

[0021] The present invention will be understood from the following detailed description of preferred embodiments, which are meant to be descriptive yet not limiting. For the sake of brevity, some well-known features, methods, systems, procedures, components, circuits, and so on, are not described in detail.

[0022] The invention is a diaper adapted for several purposes: a. to prevent movement of feces into proximity with the genitalia; b. to avoid contact of the urine with the skin; and, c. to keep the genitalia exposed to ambient temperature (to a certain degree), thereby allowing the genitals to be aerated and cooled by the ambient air (or cooling material) nearly as much as in the case of a naked body.

[0023] The sweating process constitutes only a small part of the heat exchange between the scrotum and the ambient. The main heat exchange mechanism serving to decrease the temperature of the testicles is the surface capillaiy network of the scrotum, by which the ambient temperature decreases the scrotal venous temperature. The exposure of the scrotum surface to ambient air is thus crucial for cooling of the testicles. In the female, it is speculated that heat exchange is important for normal genital bacterial type's population (microbiota). And in any case, it is known that higher temperatures promote pathogenic bacterial growth, and have an adverse effect on wellbeing.

[0024] Furthermore, higher temperatures have potential consequences on sexual development and fertility as previously mentioned; it is postulated that there may be long-term effects upon progenitor cells due to prolonged exposure to higher temperatures than those experienced without use of conventional moisture- and heat-trapping diapers. These effects may underlie decreased fertility and changes in gender orientation experienced later in the lives of infants using such diapers.

[0025] While the diaper of the invention may be made by conventional materials, compounds that replace plastic with eco-friendly solutions (e.g. biodegradable plastic) may also be used. The diaper is, in some embodiments, made in several sections. The outer front and back sections (outer diaper) are designed as in a conventional diaper. The inner front section (closest to the body) is thin and preferably of a non-absorbing material. Alternatively, this section may comprise absorbing material on the external side of this inner front section. In any case, this section has an opening adapted to allow the genitalia (penis and scrotum in male, and vulva in female) to project out through it. For a better separation of genitalia, an opening may include circulated pad such as in paediatric urine collector. The inner diaper may be constructed from thin planar material as shown in Fig. 2. This inner frontal part may functionally be hydrophilic or hydrophobic (depending on the functionality of this part). This part may be composed of a single piece of material, although in any case it is convenient to define a back section and front section thereof, ultimately covering the buttocks and the front of the baby / adult. The inner front section is provided with a hole, as also shown in all figures, allowing the scrotum and penis in male, and vulva in female to extend outside this layer. Pad and small slits around the hole allow the person applying the diaper to more easily fit it and seal the layer around penis and scrotum or vulva. Attachment of front section to back section may be accomplished by means such as hooks-and-loops or tape, which may be provided as part of the diaper or may be added by the user, so as to close the front and back sections around the user.

[0026] The material of outer diaper is preferably made of internal hygroscopic layer, middle layer with absorptive material (SAP and pulpa) adapted for absorbing any liquids, and hydrophobic external layer, as in the conventional diaper. Pockets of the inner back section (inner diaper Fig. 2) are designed to trap and hold feces, preventing it from traveling within the diaper and facilitating cleanup. The invention further prevents travel of feces from the back section of the diaper to the front.

[0027] The pockets of the invention are adapted to prevent fecal contamination by keeping the genitalia at a distance from the trapped feces. As mentioned, this prevents the possible bacterial and / or fungal growth and inflammation that may be caused by prolonged contact of feces with genitalia, as may occur in conventional diapers. Furthermore this provision prevents irritation and discomfort that will generally occur upon prolonged contact between urine / feces and skin.

[0028] Another provision for this purpose is to use a physical barrier or roller in the connecting area between the inner back and inner front sections of the diaper (e.g. around the area of the pad in Fig. 2). This physical barrier, roller or ‘hump’ will tend to decrease the movement of feces from back to the frontal area, prevents dissolution of feces by urine, prevents movement of feces from back to front area, and decreases the contamination potential on the infant’s genitals.

[0029] The outer front section of material may also have a hole, through which the scrotum but not the penis extends. As the penis is now encased between two front sections of material (inner and outer), any urine released will enter the pocket formed between these sections of absorption elements. The outer section (outer diaper) is preferably made of a hygroscopic substance (SAP and pulpa, or other), to encourage the absorption of urine by this section and not by the bodyfacing (internal) side of inner diaper, thus reducing contact of urine with the body.

[0030] The absorbed urine part in outer section is totally separated from the feces by the back inner section, which is covered by a hydrophobic layer, preventing urine diffusion from the outer diaper to inner diaper (feces). By this way feces are protected from liquefaction by urine and subsequent diffusion of feces to other parts of diaper.

[0031] The internal side (proximal, facing the body / skin) of inner front section may possibly include liquid-resistant medical glue, such as that supplied by 3M, adapted to help attachment of the diaper to the body, making fecal contamination of frontal area unlikely.

[0032] The inner section may be attached to outer section by any means known in the art, for instance by machine sewing, heat welding, gluing, or simply cutting all sections from the same original piece of material.

[0033] Figure 5 shows the main version, when the inner section is attached to outer section in the back part of diaper in the way that connection of the inner back section makes a " II " shaped configuration (Fig. 5C) when glued, and this form provides "pocket" in the back part of diaper between inner back and outer back parts. This configuration having a "pocket" makes a place for urine collection from outer front to outer back and at the same time, hydrophobic inner back part prevents the leakage of urine to feces.

[0034] Figures 6A,B show an alternative version, where the inner section is joined to the outer section in the lower place of the diaper (center bottom). The joining may be accomplished for instance by machine sewing, heat welding, gluing or other means as known in the art.

[0035] As will appreciated the invention allows for the physical separation of the reproductive organs from feces, and also largely the feces from urine (to the extent that the urine is absorbed by the pocket material of the outer sections at the time the feces are separated from urine by inner back section [Figure 2, Figures 5A-C, and Figures 6A,B]).

[0036] A key advantage of the patent lies in that the scrotum is kept at a more "natural" distance from the body and exposed to free convection of the ambient air (or cooling system) to some degree, thereby allowing the scrotum (and testicles) in male and vulva in female to keep significantly cooler temperature than body temperature, as would be the case for instance with an unclothed, naked person. These cooler temperatures are less conducive to growth / proliferation of bacterial colonies and thus will tend to suppress these and the various infections and diseases and maladies they may cause. Furthermore, lower temperatures will tend to increase the wellbeing of the wearer (especially in adults) as these temperatures are closer to those occurring naturally, without diapers.

[0037] The diaper can take the form of a normal disposable or reusable diaper, for example being comprised of conventional materials such as cotton, polyurethane, polyester, or hemp or other. Use of new compounds that replace "old fashioned" material with eco-friendly materials is also within provision of the invention.

[0038] Moisture-repellent or hydrophobic properties of the front section may be provided by means known in the art such as impregnation of conventional materials with hydrophobic surfactants (e.g. precipitated calcium carbonate, silica, or fluoropolymers, or others). Likewise, the hygroscopic properties of the diaper may be provided by means known in the art, beginning with properties of the material of the layer itself (e.g. by use of moisture-absorbents) and possibly including coatings and surfactants.

[0039] It is within provision of the invention to make use of phase-change materials (PCMs) to stabilize the temperature of their environment. As will be clear to those skilled in the art, such PCMs may be obtained or synthesized in the form of nanocapsules, with which fabric can be coated easily. Cloth treated in such a way has been shown to have excellent thermal stability (see Nanoencapsulation of phase change materials (PCMs) and their applications in various fields for energy storage and management, Advances in Colloid and Interface Science 283 (2020) 102226.)

[0040] The foregoing description and illustrations of the embodiments of the invention has been presented for the purposes of illustration. It is not intended to be exhaustive or to limit the invention to the above description in any form.

[0041] Any term that has been defined above and used in the claims, should be interpreted according to this definition.

[0042] The reference numbers in the claims are not a part of the claims, but rather used for facilitating the reading thereof. These reference numbers should not be interpreted as limiting the claims in any form.

Claims

CLAIMS1. A diaper for both sexes consisting of: a. an inner section of material shaped to surround a person’s waist, having openings for the legs, provided with a front hole for the genitalia (penis and scrotum of a male, or vulva of a female) to project therethrough, said inner section having anterior and posterior portions; b. a pad on the inner side of said inner section adjacent to and just anterior to said front hole, adapted to prevent the leakage of urine and feces to genital area and said posterior section of said diaper and avoid contact of the urine with the skin. c. an outer section of material attached to said inner section optionally having a front hole for the scrotum or vulva to project through, said hole being covered by a thin air-permeable layer, whereby the scrotum or vulva is substantially exposed to free convection of ambient air and attend to prevented from contacting urine or feces.

2. The diaper of claim 1 wherein said inner anterior portion comprises hydrophobic materials adapted to repel moisture, and wherein said inner posterior portion of said inner section comprises internal hygroscopic materials adapted to absorb moisture and liquid from stool, and external hydrophobic materials adapted to prevent moisture and liquids urine diffusion from said outer section.

3. The diaper of claim 1 wherein said outer section of material comprises hygroscopic materials adapted to absorb fluids including urine and prevented their contact with skin.

4. The diaper of claim 1 wherein said inner and outer sections are composed of materials selected from the group consisting of: cotton, hemp, bamboo, microfiber, plastic fibers, such as polylactic acid or polyurethane, polyethylene or other, superabsorbent polymers, hygroscopic materials, and water repellent materials.

5. The diaper of claim 1 wherein the inner side of said innermost layer comprises either hygroscopic or water-repelling materials.

6. The diaper of claim 1 wherein the external side of said innermost layer comprises either hygroscopic or water-repelling material.

7. The diaper of claim 1 wherein said outer section comprises hygroscopic materials.

8. The diaper of claim 7, wherein said hygroscopic materials are disposed within a circle.

9. The diaper of claim 1 wherein said outer front section is further provided with a flap or pouch adapted to cover the scrotum / vulva.

10. The diaper of claim 1 further comprising phase-change material (PCM) stabilizing the temperature of said diaper.

11. The diaper of claim 1 wherein said innermost layer of inner back section is further provided with pockets on the interior back side, so located and adapted as to entrap and hold feces.

12. The diaper of claim 1 wherein said innermost layer of inner section is further provided with a raised area (between back and front sections), which prevents travel of feces from the posterior section of said diaper to the anterior section of said diaper.

13. A diaper having a substantially high-water absorbing capacity and substantially high gas and water permeability in areas of said diaper that are in proximity to a male scrotum or a female vulva.

14. The diaper of claim 1 adapted for increasing air convection near said genitalia, by allowing ambient air to circulate through said front hole.

Images