CA3048597A1 - Transdermal feeding and dispensing device - Google Patents

Abstract

A transdermal device design that deliver nutritional and clinical constituents, specifically to provide ideal conditions before, after, and throughout prenatal development, birth, as well as during postnatal needs until infant maturity. This is accomplished through means such as a topically applied intervention, particularly with a controlled delivery system, such as a transdermal patch (100). This device can be applied before, throughout and after conception, specific periods, such as gestation, pregnancy, and lactation to name a few (120). User may use dedicated embodiments ideal for the transfer of constituents to the mother and into the infant, directly or indirectly. In one or more embodiments, wherein the device may be modified for an intended purpose outside the scope of the maternal and infant development process, such as, but not limited to: specific situations, functions, period, or condition, to list a few.

Description

Provisional Patent Application of Benjamin Chiu For TITLE: TRANSDERMAL FEEDING AND DISPENSING DEVICE
CROSS-REFERENCE TO RELATED APPLICATIONS: None.
FEDERALLY SPONSORED RESEARCH: None.
SEQUENCE LISTING: None.
FIELD OF INVENTION
The present invention relates generally to transdermal devices that deliver nutritional and clinical constituents, specifically to provide ideal conditions before, after, and throughout prenatal development, birth, as well as during postnatal needs until infant maturity. This is accomplished through means such as a topically applied intervention, particularly with a controlled delivery system, such as a transdermal patch. This device can be applied before, throughout and after conception, specific periods, such as gestation, pregnancy, and lactation to name a few. In one or more embodiments, wherein the device may be modified for an intended purpose outside the scope of the maternal and infant development process, such as, but not limited to: specific situations, functions, period, or condition, to list a few.
BACKGROUND ¨ PRIOR ART
Infants predisposed to suboptimal development and inferior expectancies of survival have become a prolonged condition that requires alternative interventions.
During the initial period of a child's lifetime, the responsibility to ensure ideal conditions for optimal growth can significantly contribute to their future chances of survival and proper development. Nutritional, biological, physiological, psychological and various other needs (vitamin D, thiamine, iron, iodine, etc.) are required to be met so that appropriate growth and progress may be achieved.
Methods such as vitamin droplets, maternal supplementation, or formula feeding has been used to address these issues ¨ usually inefficiently or with significant consequences.
Current methods that are largely used for addressing nutritional requirements are: liquid nutrient droplet supplementation of the infant, oral supplementation of the mother, and generic infant formula substitutes meant to simulate breastmilk. Each of these interventions used in reaching sufficient nutritional and physiological status, do not come without any complications and inefficiencies, which affect the integrity and treatment received by the infant or breasffeeding mother. Due to the lack of homeostatic and robust filtration abilities available in the developing infant's system, current methods are predisposed to inappropriate constituent levels and needs, as well as an increased threat to vulnerabilities and risk to hazards or hostile exposure.

2 Nutritional droplets frequently disrupt and disturb an infant's breastfeeding practice, primarily by affecting the sensitive taste and olfaction of the newborn.
Consequently, a substantial amount of infants eliciting a negative response can be commonly observed. Such that infants reject and withdraw from feeding due to the illicit taste produced from the nutritional droplets, concurrently affecting the duration and frequency of feeding.
Intestinal and digestive gas buildup, along with upset stomach are a few of the side effects observed in infants administered with both methods ¨ particularly vitamin droplets. Therefore aversion by the infant has adverse effects and can be detrimental to the development and health of the growing individual. The use of these fluid derived mixtures are also prone to high risks of improper administration and low compliance, therefore may lack consistency and favorable results. This is predominantly due to dosage inconsistencies resulting from human error, and lack of tenacity through inconveniences. The low compliance and high rate of failure to administer successfully, can be attributed to the requirements of the nutritional droplet process, which can be tedious, and involve diligence in daily application of the supplement.
Formula feeding is substantially inferior to breast milk in both nutritional composition and in the non-nutritive bioactive factors that promote healthy growth and survival. Consumers may be misinformed of the capabilities and have an incorrect false pretense to a safe and complete superior breastmilk substitute. Although it is inferior in quality, substance, abilities, safety, and efficiency, while also being at risk to contamination from the solvent. Infant formula is standardized within a narrow compositional range, lacking the ability of a dynamic intervention such as breastmilk that adjusts its own components to suit the varying requirements of an infant.
Consequently, human milk produced by a lactating mother is distinctively suitable to the human infant in terms of nutritional needs and non-dietary bioactive factors that encourage proper development and survival. Infant formula feeding practices also disrupts the positive feedback mechanism of the maternal milk producing system, reducing the ability of the female system to generate milk in the appropriate quantity and quality, and eventually if prolonged, causes the lactating individual to lose all ability to yield breast milk. Therefore, creating a reliance and dependency on infant formula or other means of feeding the infant that is not available from the non-lactating individual's breast milk. An occurrence with the reverse effect when breasffeeding, lactating abilities are encouraged or maintained through a positive feedback process.
Improper use are common in currently available breastmilk fortification and breastmilk substitute products. Incorrect administration methods and inappropriate off-label use, such as direct infant oral application, additive to pumped breast milk, application to the perimeter of the nipple, etc. Furthermore, due to the direct application on the infant, as well as the lack of protective constituents able to limit the strength of exposure, infants may have a strong aversion or rejection for vitamin D or liquid drops (Baby Center, 2013). Therefore, with an intuitive and straightforward peel-and-stick procedure that is applied to the breast, or designated area on the maternal body, accomplishes the objectives of the device while reducing any predispositions or residual effects. Such that, an intervention that does not entail or require the treatment, procedure, or any component of the process be applied to or exposed to the infant, as well as physiologically restrict, screen, and innately control the fortification process and its effect, in order to limit the potential for complications and errors.

3 Daily administration, if not multiple applications a day using current fortification or supplementation methods may be required. For example, nutrient droplets at suggested intervals may be necessary for the treatment. Therefore, a process that can be engineered and customized to provide the controlled release of a specified amount may be advantageous and desired. Such that a substrate be precisely released over a period of time or in desired intervals, such as a week. Hence, offering an additional convenience and improvement through eliminating prerequisite work required by other methods (Higo, 2007).
Current existing methods may also be predisposed to additional volume based limitations. This is due to the weight, size, and dimension of certain components or constituents.
Consequently, restricting or requiring additional storage and transportation needs and costs.
Therefore, by providing a supplementary method that can be light, compact, and minute in nature add further convenience that can be achieved. This is offered to the manufacturer, purchaser, and user in regards to storage and transportation advantages throughout the supply chain, as well as during consumer use. Although certain methods, such as liquid droplets, may offer a slight cost incentive when manufacturing is considered, the production expenses may not appear to have extenuating differences overall. This is due to many reasons, particularly since adjustments and modifications to the transdermal patch can be significantly customized to reflect the needs of the user and their intentions.
Substitutes for breastmilk, such as infant formula, lack many non-nutritive bioactive factors that come at the consequence and detriment of the infant and mother.
This includes the absence of cells, anti-infectious and anti-inflammatory agents, growth factors, and prebiotics intended to be transferred by the mother when breastmilk is consumed. These physiologically produced constituents cannot be synthetically produced and incorporated into the infant formula. Consequently, this results in numerous complications and health risks when an infant does not receive or have access to these bioactive factors at an acceptable level level. This may result in an increased risk of Sudden Infant Death Syndrome (SIDS), infections, poor neurodevelopment, elevated blood pressure and cholesterol, eventual development of diabetes and obesity, to list a few complications. Feeding practices that discourage or replace breasffeeding methods are correlated to the reduction of infants consuming breastmilk.
Therefore, this results in inadequate physiological and neurological development, a compromised immune system, high opportunity costs, and several more impediments (Cattaneo, 2007; Drago, 2011).
Oral supplementation is commonly predisposed to the first-pass effect, but it is still one of the most commonly practiced method currently used to fortify and supplement the required amount of nutrients, such as vitamin D, to the breasffeeding infant. This approach is also prone to many disadvantages and safety concerns regarding both the lactating individual and the feeding infant. Two primary methods currently exist for oral supplementation, this is accomplished through either selecting to boost the nutrient in the mother ¨
assuming that it will increase the availability in the blood content to be transferred into the breast milk; or to apply to the child through direct or indirect procedures.

4 Selecting to increase the nutritional content in the circulation of the lactating person usually requires extremely high daily doses at consistent intervals, this is prone to many detriments as well as the disadvantages previously outlined. Depending on the first-pass effect, the composition, and specifications of the nutrient, the nursing mother may need to consume more than 16 times the amount in order to provide the necessary levels required, such as for vitamin D, 6400UI of vitamin D is needed to provide 400 Ul in the breastmilk (Furman, 2015).
Direct supplementing techniques on the infant has many concerns regarding compliance, aversion, taste, and numerous other omitted benefits. There has been many documented cases of infants that withdraw from feeding due to the taste applied to the nourishment or perimeter of the feeding area. Since the economic status of a community, commonly, but not always, reflect an individual's access to proper nutrition and growth, the diet of the population also changes due to the location. Therefore, it is not uncommon for different communities to lack different nutrients in breast milk, which may have properties incompatible with simple diffusion, thus different regions could require specialized intervention or more novel transdermal methods, such as micro needle technology. A universal, one-size fits all approach, such as infant formula may not be appropriate in this situation.
Although infant formula may contain all the essential nutrients an infant requires, it cannot adapt to the specific needs ¨ that is consistently changing ¨ in a growing infant or community, a function present in breastmilk. For example, the lactating individual physiologically changes and adjusts the quantity and quality of nutrients an infant needs during feeding (Cattaneo, 2007). The milk producing body is sensitive and acute to the requirements of the baby, by using this system as a tool to yield the proper dosage and amount allows for optimal consistencies an infant requires (Cattaneo, 2007). Instead, the constituents of infant formula is restricted to a generalized amount for each nutrient that serves as the standard quantity regardless of any changes to the infant. However, this substitute feeding method is able to provide adequate amounts of Vitamin D, a property absent in many breastfeeding mothers in the developed and developing countries. Therefore, formula is often chosen and relied upon for this particular advantage ¨ the ability to deliver required nutrients at acceptable levels.
Conversely, an improved intervention can replicate this competitive advantage and appeal of infant formula users, while also improving and incorporating practices beneficial to the population, among many other abilities.
SUMMARY
In many regions of the world, children fail to develop in accordance with the international growth chart or successfully reach maturity due to a lack of nutrition during critical periods of development. Without the adequate nutrients to meet an infant's needs, predisposes the individual to short stature, high risk of mortality, cognitive and physiological abnormalities, as well as many other ailments and susceptibilities. The first 1000 days after conception, infants go through an important period of development which requires sufficient supplies of nutrients;
failure to obtain adequate amounts significantly interferes with the health of the child as well as present many long term consequences.

5 Breastfeeding, particularly when exclusively performed during the first six months provides numerous health and dietary benefits, especially if the milk offers appropriate nutritional content. Although being highly advised by the World Health Organization, the number of infants under six months that are exclusively breastfed still remain low in many regions of the world (Heymann, Raub, & Earle, 2013). Therefore, our objective is to provide a product which allows nutrient deficient infants in the world meet their nutritional requirements, while also providing a safe intervention that encourages the important practice of breastfeeding. In order to address both these issues, we have proposed the concept of the transdermal breastfeeding patch (TBP) ¨ official name to be determined, transdermal pregnancy patch, transdermal health patch, transdermal birth patch, or other related name. This allows for the controlled release of various nutrients through a topically applied device on the external breast tissue, or appropriate area, which will travel transdermally into the bloodstream, milk lobules, and breast milk, or desired target.
Numerous communities in every country are facing issues with nutrient deficiency, dietary insecurity, food accessibility, and nutritional instability. Without access to a diverse nutrient dense diet rich in micro and macronutrients pose significant complications, particularly for infants who rely on their mothers to provide breast milk in sufficient quantities and qualities.
In many situations, it may not be directly related to dietary concerns, but primarily stemming from environmental causes, such as seasonal changes or geographical disadvantages. For example, vitamin D is a case in which many individuals in the world are nutrient compromised, particularly in the urbanized or industrialized economies. Due to nutrient deficiencies in the breastfeeding mother, she will be unable to produce and supply the breast milk with appropriate nutritional content. Although breast milk is efficient in acquiring nutrients from the lactating mother, due to the state of nutrient deprivation or malnourishment, the integrity of the breast milk and infant are frequently compromised, therefore human intervention is required.
Embodiments may show immediate and observable utility in many tasks, and may show improvements of the following but not limited to: quality, speed, accuracy, effort, convenience, cost, time, commitment, accessibility, requirements, organization, and resources dedicated to various undertakings. Such as, but not limited to: providing significant improvements to dispensing appropriate nutritional content, improving the maternal environment while reducing the significance of the first past effect, encourage the use of recommended breastfeeding practices, discourage improper feeding methods, minimizing any intervention on high risk individuals, reduce human error, limit intrusive actions, and allow certain procedures to be omitted, as well as minimize reoccurring expenses required by other alternatives, to name a few. This project involves the construction of a system that modifies the biological status of a subject, such as the nutritional composition of breast milk which may then provide other significant benefits and advantages. The proposed system involves the use of an engineered epidermal adhesive bearing the substance(s) to be incorporated into the breast milk or mother ¨
this will be applied to an individual in lactation, gestation, throughout various natal states.
Administration of the patch allows movement of the desired nutrient(s) from the adhesive to the individual and ultimately into the target tissue or objective, such as breast milk to be consumed.

6 ADVANTAGES
Accordingly, several advantages of one or more aspects are as follows: the transdermal clinical (or nutritional) device is a system that functions to modify the composition in an area, or subject of interest so that a desired result can be achieved. Although this intervention is able to modify the nutritional quality and components in breastmilk, as well as the condition of the maternal environment, other capabilities may also be achieved from this device. For example, breast milk may be modified with constituents that is able to elicit certain functions, in addition to being fortified with constituents that address any lack in quality. Adopting this method reinforces breastfeeding practices as well; therefore improving nutrient bioavailability, nutrient specificity, and providing live cells, digestive enzymes, immunomodulators, and growth factors. This intervention also provides a convenience factor due to the limited weight, size and compact nature of the device, which can be observed in improved storage and transportation capabilities when compared with other currently offered products.
Other advantages and abilities include, but are not limited to: dynamic ability to modify milk components for specific needs, allow highly customized components to be incorporated and modified to individual needs, the ability to be selective of the nutrients minimizes risk for toxicity, reduce the consequences of the first pass effect, prevent daily administration at high dose concentrations, encourage breasffeeding practices, cost incentive, minimizes adverse effects due to lower drug peak concentration, avoid the necessity to administer frequently or on multiple occasions a day, control multiple constituents releasing at varying intervals or prolonged instances while regulating with precise quantities, increase compliance through improved convenience, reduce procedural requirements necessary in other interventions, minimize the need for user accountability. Additional advantages include the ability to: prevent direct administration onto the infant while limiting disconcerting stress factors such as off-putting taste and smells, minimize complications or side effects existing in other methods, improve accuracy and application requirements by decreasing human error, as well as reducing the possibility for contaminants and unhygienic conditions, restrict the ingestion of additives that are unsanitary frequently affecting fluid solution based methods, decrease the risk for infant rejection or withdrawal that may interrupt successful breasffeeding completion, improve digestive and intestinal metabolism, as well as many other benefits. Further details as well as additional advantages in one aspect or another will be expressed in the following sections, figures, and accompanying segments.
It has been well established through scientific research and The World Health Organization that infants should be exclusively breastfed for the first six months at minimum.
This is recommended for numerous reasons, breast milk provides exclusive bio-active factors such as secretory IgA antibodies, and other immune and transfer factors not provided by other methods to the neonate, while significantly decreasing the infants risk for sudden infant death syndrome (SIDS), respiratory tract infections, asthma, allergies, as well as providing many other additional benefits. Although there are numerous advantages to breasffeeding, the number of infants being exclusively breasffed are minimal in many areas of the world (Heymann, Raub, &
Earle, 2013).

7 In Canada, about one in four mothers will breasffeed exclusively for the first six months, and globally, less than 40% of individuals under six months are exclusively breasffed (Statistics Canada, 2015; World Health Organization, n.d.). Therefore, by offering a process that addresses the disadvantages and inefficiencies of naturally produced human milk, will result in significant improvements to the proportion of infants being nursed by breasffeeding practices.
For example, by mitigating and improving any nutritional insufficiencies breast milk may have, while concurrently supplementing the mother simultaneously, particularly through the utilization of breasffeeding practices to meet the dietary needs of the infant, creates a platform that aligns with the goals and advantages this device and procedure has to offer. The transdermal conceiving and breasffeeding patch seeks to achieve these objectives and more.
Although the transdermal breasffeeding patch (TBP) is able to address nutrient deficiencies in infants, as well as encourage breastfeeding practices, many other significant advantages may be provided furthermore. The patch may be applied and adapted to the needs of the user or situation, for example, allowing for the device to be applied during or before any period of infant development, even when expecting or planning. In many areas of the world, certain important nutrients are difficult to acquire due to the climate, accessibility to resources, and other various reasons.
In some situations, in order to acquire these nutrients through food, or using current supplementation methods would be cost prohibitive, if not impossible (Mcgillivray, 2006).
Certain nutrients dependent on environmental conditions cannot be controlled or effortlessly altered, such as the exposure to natural light or the ability to access natural resources.
Females, particularly when ovulating or giving birth, can be regularly observed to be lacking iron and other significant minerals and nutrients due to the loss that precedes this function. By transferring nutrients to the maternal system or breast milk, through the lactating individual, via a reservoir dispensing mechanism, allows this individual access to the reserve supply contained on the device which is designed based on the needs of the situation.
Therefore, the lactating or conceiving individual would be in, or be able to, ideally reach the ideal nutritional standard throughout the useful application of the patch.
By offering nutrients, which had not otherwise been available, and particularly inexpensively, results in significant benefits offered by this device. The ability of an instrument that can enclose and accurately control the rate and quantity of contents being transferred to a subject over extensive periods of time; particularly in a noninvasive and non-obstructive manner, can be desirable and advantageous to the user.
Due to the pharmacodynamics and pharmacokinetics of the transdermal patch, application of the dispensing device and consequently the pharmacological constituents, will be ideally administered to a developed adult initially, which furthermore will be transferred to the less mature neonate, or growing infant through the consumption of breastmilk.

8 Due to the more established immune system and comprehensive filtration capabilities in the adult, by administering any constituents to the adult initially will offer an additional safety precaution and screening procedure against possible detriments. Since the more robust nature of the adult physique is at less risk for developmental influences, overdoses, and side effects, the existence of this transitional stage, prevents direct exposure of a neonate, infant, or developing individual ¨ a concern expressed by many mothers as well as the public. Evidently, this is an issue prevailing in currently offered methods and supplement based practices, which specifically require the constituents be directly administered to the infant, such as through unscreened liquid droplets or direct ingestion of infant formula powder that may be combined with a predisposed solvent, such as contaminated water. Therefore, the developing infant is more likely to be predominantly high at risk for developmental or health concerns, particularly when compared to feeding processes requiring the infant to breastfeed.
Topical applications, or transdermal administration of certain constituents is highly preferred over other methods of administration due to the advantages offered in that process.
For example, oral application often requires consistent and inconvenient scheduled application for the expected result to take effect. This manual administration of the treatment will likely need to be physically performed and require allocated attention designated to its application. Often, high dosages are required for the components to travel successfully to the necessary area, in the proper capacity and arrangement for it to become incorporated into the breast milk or target location.
These are a few complications that are currently existing and observable in the leading methods and predominant products available to the public. Due to the limited options available, the choices are restricted to primarily the three existing methods that are inferior and prone to issues, therefore an alternative option is necessary to avoid those problems.
In most situations, the contents provided by the transdermal device, will also be supplementing the lactating, conceiving, or expecting host with the constituents they are deficient or predisposed to. Typically, breast milk may not reach the ideal nutritional standard, as a consequence from a deficiency demonstrated by the host. Therefore, optimal conditions in the host is generally met when the breast milk achieves appropriate levels as well. Hence, the components from the nutritional aid will transfer through and supply the breast milk until ideal conditions are reached, generally requiring the host to demonstrate deficiency conditions conducive for supplementation of the breast milk.
If a satisfactory nutritional standard is not initially provided by the host, they will be supplemented through the attachment of the device as a result. This is possible due to the readily available nutritional reserve contained within the device that can be freely accessed by the host when applied to the subject. Therefore, this device provides additional advantages such as providing the nutritional needs for the maternal host, as well as contributing to the other primary goals of the application.

9 DRAWINGS ¨ FIGURES
The following figures are labelled using the same number for closely related embodiments with different alphabetic suffixes ¨ although the labels may not be confined to that embodiment.
Fig 1A to 1D illustrates various aspects of a transdermal device with a porous membrane that allow movement of the materials from one location to the other, in accordance with one embodiment.
Fig 2A to 2D demonstrates integration of various mechanisms or functions onto the transdermal device, such as microneedles, capable of penetrating the skin.
Fig 3A to 3B displays an embodiment that divides the transdermal device into predetermined regions, generally to allow for different regions to behave differently, store different constituents, or have different material compositions, to reference a few examples. Mention Fig 4A to 4B shows a highly customizable transdermal patch that allows for desired regions or constituents to be individually removed, applied, and placed in a chosen area.
Generally a peel and stick mechanism.
Fig 5A to 5D conveys one of more embodiment renditions of a transdermal band, allowing for entire circumferential enclosure to semi enclosure. 5C displaying a reusable band with rechargeable capsules.
Fig 6 illustrates a layered perspective with a lifted side of the transdermal patch.
Fig 7A to 7B demonstrates a transdermal patch of a different shape, ideal for application around a circular object. 7A depicts a semi enclosed form, 7B depicts a fully enclosed form.
Fig 8A to 8B illustrates embodiments of the transdermal patch with integrated abilities, such as, but not limited to aromatic expenditures, as well as device condition determinants.
DRAWINGS ¨ REFERENCE NUMERALS
100 transdermal patch 112 longitudinal side 102 outer covering 114 lateral or opposing longitudinal side 104 compartment or reservoir 116 adhesive surface 106 membrane 118 liner layer 108 pores 120 breast application 110 side view or cross section perspective 122 breast

10 124 one of many alternative shapes 154 stratum granulosum 126 release tab 156 stratum spinosum 128 nipple 158 stratum basale 130 microneedle delivery 160 layers of epidermis 132 microneedles 162 transdermal band 134 constituents or granules 164 refill chamber 136 skin puncture 166 replaceable capsule 138 skin or epidermis 168 wrist, arm, etc.
140 layers of skin 170 replacement opening 142 epidermis 172 scent diffuser 144 dermis 174 infant 146 hypodermis or subcutaneous tissue 176 indicator markings 148 blood vessels 178 transparent window 150 stratum corneum 180 color concentration gradient 152 stratum lucidum 182 patch with additional function(s) DETAILED DESCRIPTION
One embodiment of the transdermal dispensing apparatus is presented in Fig 1, the topically applied device 100 is created from various materials necessary to carry out its functions, while also allowing for the proper handling and storage of its contents. Depending on the needs and constituents of the bandage, several layers or membranes of various sizes and dimensions may be used at the discretion of the individual skilled in the art.
For example, a backing layer, liner layer, adhesive layer, drug-containing layer, drug reservoir, hermetically-sealed compartment, release liner, microneedle surface, prime coat, microporous membrane, and control membrane to name a few, these may also be combined in different combinations and variations. A person knowledgeable in this art may simply select a material or method for their better judgement in order to achieve a specific result, particularly when a multitude of constituents may be combined under one patch, or in conjunction with numerous patches.
Various administering systems may also be necessary in order to accommodate and incorporate the particular requirements of the component, such as adhesion promoters, plasticizers, antioxidants, filler compounds with rubber adhesives such as polyisobutylene, acrylate polymer, colloidal silicon dioxide, etc.

11 In accordance to one or more embodiments, the outer covering 102 could be made from various preferred materials suitable to its needs, such as, but not limited to, plastic, rubber, acrylate polymer, polyisobutylene with a plasticizer; ideally a soft, light, and nonirritating material, or any substitute that contains other desirable properties.
Adjustments may need to be incorporated into the product specifications 100 depending on its intended use or desired needs, such as to maintain the integrity of the constituents, the ability for the delivery system to administer appropriate dosages throughout the predetermined length of use, the optimal conditions that limit environmental facts such as moisture, oxygen, and light;
as well as numerous other properties ¨ whether from a clinical purpose, functional purpose, or any other component such as manufacturing needs, cost measure reasons to list a few. In one or more embodiments, the reservoir compartment 104 is separated by a membrane 106, possibly with pores 108 or other feature(s) such as microneedles. Illustrated in Fig 1C, demonstrates the attachment of the device on the breast 122, minimizing distance to the milk ducts 120, among many other alternative locations. However, the apparatus 100, layers 102, matrix 104, and protective covers 106 can consist of numerous other materials, as well as be, or in conjunction to, be manufactured with other desired processes that allows specific properties of the embodiment to be achieved. Due to the needs of the task, a person skilled in the art may simply select suitable materials, specific dimensions and measurements, different layer properties and number of layers, unique constituents, or adjust the methods to their better judgement 124.
In one or more embodiments, the interior storage compartment 104, equals to or is larger than the diameter 112 and length 114 of the predetermined items, the additional spacing to allow for variance and movement. A person skilled in the art may easily determine the space allotted for this purpose based on the material and result desired. Such that the opening 106 may have a reduced dimension comparative to the diameters 111/112 in order to avoid interfering with the adhesive corners as well as prevent loss of contents to the surrounding.
Additional layers and compartments 104 that may, or may not provide alternative functions, may also be incorporated throughout, as well as within the device 102 to 116. For example, microneedles 130 with insertion lengths 132 generally within 20 to 1500 microns, and diameters not more than 30 microns may be integrated and utilized on the proposed delivery system.
The principal purpose for this device was to create an alternative method for preventing, or combating malnutrition in children; predominantly breastfeeding infants and women who are particularly lactating or expecting. This is accomplished through the design of the transdermal breasffeeding patch (TBP) 100. The theory and mechanics for TBP relies on the movement of its constituents from the reservoir 104 into the targeted location 122, for example, the patch may utilize diffusion of nutrients through surface dermal application 122, such as applying topical vitamin D, K and iodine to list a few. This treatment method utilizes the construction of a proprietary adhesive 100 applied to the lactating or conceiving mother 120, generally on the breasts 122, close to 120 or adjacent to the nipple 128. Selective placement of the patch will optimize the diffusion of nutrients into the maternal system 122, such that it will be incorporated into the breast milk, which will supply the nutrients and components to the infant upon consumption ¨ this will also supply the treatment constituents and nutrients into the systemic system of the women.

12 In accordance with one or more embodiments, the reservoir-containing layer 104 could be incorporated with the adhesive layer 116, which could be in direct contact with the liner layer 118 such as in a monolithic patch system. Whereby removal of the liner layer 118 pre-administration, exposes the adhesive layer 116 for direct contact with the skin 122 and transport. A pull tab 126 for grasping the adhesive may also be present for the user's convenience. Due to the high customizability of the device, a person skilled in the art may have numerous parts and choices in the design of the components suitable to their needs, such as, but not limited to one or more embodiments varying in filler, inorganic salts, clay components, polyisobutylene, drug component, plasticizer, specific layers, incorporation of oils, and the such.
It is also important to note, in one or more embodiments, the application surface is not required to be in or on the vicinity of the breast 122, but could be elsewhere on the individuals involved, such as but not limited to the arms, legs, hip, thoracic cavity, etc.
Children and lactating women were determined to be the specific focus due to the high prevalence of malnutrition in those populations, while also being the greatest at risk (Gupta, Dadhich, & Sun, 2015). A prolonged and continuous cycle of malnutrition, inadequate quality and quantity of breasffeeding, premature weaning, and reduced transition period from conception to pregnancy is observed in this demographic ¨ this compromises the needs of the infant and health of the women (Vesel, Bahl, Martines, Bhandari, & Kirkwood, 2010). Current methods prove to be inefficient, if not harmful for numerous developing children and nursing women, such that it discourages or prevents the use of breasffeeding practices, lacks the ability for the nutrient or components to be delivered to both individuals, requires additional procedures and attention from the user creating further inconveniences, relies on inaccurate and inconsistent application techniques, and does not provide as many other additional benefits or improvements to previous and existing inefficiencies, unlike what is offered by the TBP. Which also strives to limit any risk factors or adverse effects, through various means such as transfer factors or rate control membranes to list a few.
Naturally occurring breast milk from healthy lactating women commonly provide all the nutrients an infant requires, disregarding a select few, such as vitamin D and iodine; while malnourished women produce breast milk of poor to severe quality. This may be attributed to a lack of accessibility or consumption in appropriate quantities of diverse nutrient groups.
Subsequent methods, such as oral supplementation is predisposed to the "first pass effect", reducing the bioavailability and compromising the treatment received. Other issues faced by this methodology, such as liquid droplet supplementation, is the aversion to the taste and negative response by the infant, subsequently causing the possibility of other consequences, such as reduced feeding sessions, therefore inadequate growth, nutrient deficiency and developmental concerns. Existing methods, such as infant formula lack vital physiological and immunological bio-factors that are provided during breasffeeding. It is also comparatively more expensive with additional expenses and recurring financial requirements to replace the product, when the item is consumed. (Vesel, Bahl, Martines, Bhandari, & Kirkwood, 2010).

13 TBP aims to provide deliverable nutrients and treatments lacking in the breast milk, infant, maternal system, or applicable article through transdermal or uninterrupted delivery into the bloodstream and milk (Barger, 1992). This method allows a controlled and optimized program to be used with high ease of application and transport convenience, while promoting and encouraging breasffeeding practices, as well as provide nutrients to both the infant and lactating women. For example, in order to address the needs of malnourished individuals, while preventing many developmental disabilities in infants, specialized TBPs can be designed to contain select diffusible or non-diffusible nutrients for use during the different stages of growth (Gupta, Dadhich, & Sun, 2015). Particular nutrients can include, but not limited to Vitamin D, E, A, K and Iodine (Alsaqr, Rasoully, & Musteata, 2015).
Nutrient deficiencies with improper practices are common in growing infants and can have detrimental consequences to the development, health, and survival of the infant. Although the severity of the outcome is more prominent in developing societies, affluent countries equally face a concerning lack of breastmilk that meet the nutritional needs of a developing newborn. By addressing the dietary requirements of the growing neonate, as well as adopting breasffeeding methodology during this critical phase of growth can yield significant advantages (Gupta, Dadhich, & Sun, 2015). Breasffeeding, particularly when exclusively performed during the first six months provides numerous health and dietary benefits, especially if the milk offers appropriate nutritional content. Although being highly advised by the World Health Organization, the number of infants under six months that are exclusively breasffed still remain low in many regions of the world (Heymann, Raub, & Earle, 2013).
Therefore, our objective is to provide a product which allows nutrient deficient infants meet their nutritional requirements, while also providing a safe intervention that encourages the important practice of breastfeeding. In order to address both these issues, we have proposed the concept of the transdermal breasffeeding patch (TBP) ¨ name to be determined. This allows for the controlled release of various nutrients through a topically applied transdermal device on the external breast tissue, or any appropriate location that will allow it to travel into the bloodstream, milk lobules, and breast milk ¨ for example, a possible primary objective of the delivery patch would be to supplement and supply vitamin D to the members.
OPERATION
In one or more embodiments of the TBP method will utilize the construction of a proprietary adhesive 100 applied to the maternal individual, generally on the breasts 122, close to or adjacent to the nipple 120 optimizing transport or diffusion of the constituents into the breast milk or desired target. This will supply the components to the infant upon treatment, and will also supply by association 120 into the circulatory system of the individual. This method primarily functions during breasffeeding, or throughout any period of infant development, and is used to provide nutrient supplementation, but can also be altered to transmit applicable medications or capable constituents suitable to the requirements of the infant, via the consumption of breast milk or through a direct manner.

14 In accordance with one or more embodiments of the device, to administer the invention would require exposing the adhesive 116 by removing the liner layer 118¨ a grasping portion 126 is also provided for improved convenience. After revealing the adhesive surface 116, it may be attached to the breast 122, skin 128, or other appropriate area of choice on the expecting or lactating individual, as well as any applicable individuals involved. This allows the constituents 134 from the reservoir 104 to be conveyed into the desired target areas, such as, but not limited to the breast milk of a lactating individual, the circulation system of a conceiving or conceived mother, etc. Thereby actively raising the concentration of the transferred constituents in the breast milk, maternal system, infant, and other associated components, as well as increasing the availability to the infant. Since this method relies on supplementing the breast milk, and maternal system, for infant consumption, breast feeding is encouraged and optimal standards are supported throughout the conception, gestation, and beyond to achieve desirable conditions and development.
In one embodiment, the mechanism for the transdermal health patch relies on the ability of certain elements to diffuse or actively transport through the epidermal layers of the skin and into the systemic system, or milk-producing lobules, via transdermal application 120. The non-diffusible or stagnant components can be transferred using transporters, or with the assistance of transdermal techniques and technology, such as but not limited to, microneedles 130 or skin permeation enhancers. Transdermal patches 100 is an adhesive 116 attached to the skin that releases controlled substances 134, usually through a thin porous membrane or through body heat dissolving layers, where the substances are embedded on the adhesive 116 or on different layers 106 of the patch. Although in one or more embodiments, passive and active transport are relied upon, while other processes may also be possible.
Currently, there is a lack of research and academic literature pertaining to the notions and mechanics suggested by the TBP. Therefore, although experimental research and trials are essential to the development of the TBP, it also has an academic and scientific value as well;
from the findings it can provide an opportunity to contribute novel data and literature for peer review. This product has the potential to introduce a unique approach to addressing nutrient deficiency, while also allowing for the discovery of new scientific insights.
Studies have been conducted on topical applications and the effect it has on the circulatory system or epidermis, but diffusion into certain organs is still novel and appears to lack significant academic insights.
Although there are numerous ways a topical patch may be designed, we have stated one of the various embodiments possible, but is not intended to limit the scope of the invention.
Initially, a certain amount of the constituent(s) is gathered, the composition is then mixed with a polymer ¨ for example a long chain silicone polymer, the polymer blend is sheeted and left to cure at room temperature for an appropriate amount of time such as 8 hours.
After it has dried, a foam backing is applied before cutting the product into a specific dimension. It is now ready to be used, by first removing the protective coating layer with the adhesive side applied to the skin.
An individual skilled in the art may make adjustments appropriately or approach with different procedures, such as, but not limited to: using vacuum pressure and heat, addition of enhancers and agents, solvent extraction, etc.

15 ADDITIONAL EMBODIMENTS
Additional embodiments are illustrated in Figs 1-36, in each case, additional modifications may be incorporated and specific parts may be selected and integrated when refining the final product.
Understandably, a person skilled in the art may alter the dimensions, properties, characteristics, details, placement, specific features of the various parts that are mutually involved or engageable, or that participate in providing a function and property of the embodiment. In accordance with one or more embodiments, the proposed device is an improved invention for providing the proper constituents, such as nutrients to an individual, as well as other components. It can also exceed the scope of a storage and dispensing vessel, for example, it may provide additional functions and assist in improving the performance and efficacy of previous methods.
Embodiments may display immediate and observable utility in numerous tasks, and demonstrate improvements in the following, but not limited to: speed, accuracy, effort, convenience, cost, time, compliance, accessibility, requirements, organization, and resources.
Such as, but not limited to improvements in: dispensing, controlling, releasing and administrating treatment with predetermined conditions, as well as reducing human error, or certain procedures and reoccurring expenses existing in other methods, to name a few. For example, numerous embodiments regarding, but not limited to: distribution of the concentration of constituents (concentrated levels near the center or uniformly, etc.), release liner material( paper, poly-coated paper, polyester film, HDPE, etc.), duration of application (12 hours, 3 days, etc.), backing material (foam fabric, woven, non-woven, scrim, ribbon, composite, sheet fabric, polyester, polyethylene, vinyl, combination, etc.), specifications (color, dimensions, shape, thickness, configuration, pattern, texture, translucency, etc.), adhesive concentration used (acrylics, polyvinyl acetates, rubbers, ethylenevinylacetate copolymers, polysiloxanes, polyurethanes, plasticized polyether block amid copolymers, plasticized styrene-butadiene rubber block copolymers, mixtures, etc.), constituents (vitamins, minerals, nutrients, drugs, bioactive factors, physiological components, etc.), weight percent, and numerous other variants to the embodiments of the invention.
Various additional embodiments, such as the examples illustrated in Figs 3-10, are one of many different possibilities. In each case, additional modifications may be incorporated and specific parts may be selected and integrated when refining the final product.
Many other options are possible, which may depend on the specifications of the other components, such as material or thickness; modifications for improved attachment, such as fastening of pieces, locking mechanisms, material options like a Velcro dispensing band, among the many possibilities. The properties of the constituents, the cost of the device, the preferences to the needs and performance desired, the area intended to be used for attachment, as well as numerous other alternatives.

16 Structural changes and embellishments may be possible for one or more embodiments, such as channels or troughs may be incorporated to enclose the different constituents and allow additional control.
This is demonstrated in Fig 3. Longitudinal channels, indicated divisions, sequestered sections, or similar boundaries may run along the patch with specific properties that allow the components to be released or contained in a predetermined manner. In one or more embodiments, adhesive regions may be localized to certain areas, such as at the edges or throughout the contact surface therefore minimizing or preventing any unintended tangential detachment of the pieces.
This can be observed in Fig 4. To provide additional customization and optimization in one or more embodiments, detachable sections may be possible in order to administer only the necessary components while removing or limiting the extraneous constituents to be applied at a different time.
In addition to providing modifiable or convertible embodiments, additional embodiments designated to different needs or stages of conception, gestation, lactation, and such may also be desirable. This allows for the contents to be appropriate and optimized to the needs of the situation. In accordance with one or more embodiments, the adhesive may be oriented in different positions and angles to allow proper fastening of the patch.
Depending on the properties and use of the embodiment, it may also be secured to a variety of different areas on the body, such as breast, abdomen, back, chest, legs, arms, scalp or other suitable skin surface and may include formulations in which the constituents are administered in patches, ointments, creams, suspension, lotions, pastes, gels, sprays, foams, oils, to name a few.
In one or more embodiments, specifically adjusted transdermal devices associated with different stages or situations may be designed. For example, in relation to the needs of the maternal system and infant's development, certain patches designated for a particular function or purpose can be produced. Important situations and needs, such as, but not limited to: a recovery patch, maintenance patch, prenatal patch, complete maternal patch, systemic prep patch, after birth patch, menopausal patch, pubescent patch, daily or weekly or monthly patch, to present a few possibilities.
The customized transdermal devices may be developed for an application outside the scope of the maternal and infant developmental cycle, in achieving nutritional and overall wellness. Therefore, one or more embodiments are designed and developed to address certain situations, a certain need, or provide a cumulative or overall effect, for example, and not limited:
recovery patch, maintenance patch, prenatal patch, complete maternal patch, systemic prep patch, after birth patch, menopausal patch, pubescent patch, muscle recovery patch, rebuilding patch, workout patch, amino patch, focus patch, wakeup patch, patch to increase alertness, exhaustion patch, emergency patch, essential survival patch, diet patch, meal supplement patch, meal substitute patch, daily or weekly or monthly patch, to present a few possibilities.

17 The vessel used to deliver its content may also significantly differ from one structure to another, for example, in one or more embodiments, a band, wrist band, arm band, or other design that wraps completely or partly around a component of the body or affiliated component may be possible. This could allow for continuous release as well as act as an accessory, jewelry, fashionable component, that may hold better, longer, and during activities. It may also be easily removed and have a reusability feature to it. For example, protein could have a quick release as well as an extended release during and after muscle use. One or more embodiments may also have an analytical feature as well as a method to determine the condition or level of use left. As well, other embodiments may have the ability to store any excess nutrients or, abstract any nutrients in the body that may be of oversupply. Therefore, the embodiments can determine when and how much of its contents will be monitored and controlled.
Other related counterpart embodiments may be inspired by the transdermal intervention, such as, but not limited to a testing kit that determines the status of certain components in the individual's body. This may be done through different methods, some being analysis of the blood, hair, skin, other tissue, or other related material.
Other accessories or aesthetic application may also be possible, such as designs or attractive smells. Odors that encourage breastfeeding, appetite, or other functions and situations may be desired, as well as other visual and sensory possibilities.
That being said, the transdermal device may not only be limited to human administration, application onto another specie or suitable receiving object may also be possible. For example, but not limited to:
application onto bovine, swine, etc. or applied to a container, food, plants, enclosure, any material that may use the constituents, and many other possibilities.
In Fig 1A to 1C, the embodiment has a porous membrane to allow movement of the constituent from the reservoir to be released. According to Fig 1A and 1B, different orientations and sections of the instrument is illustrated. Modifications can be implemented on the device to achieve a desired purpose, demonstrated in Fig 1C, where variations in size, shape, color, material, components, integrations, movement, layer, and placement have been slightly adjusted. In Fig 1D and 6, one of numerous possible combinations of bilayers are illustrated, showcasing the ability to integrate different materials and roles if preferred.
In Fig 2A to 2C, displays different orientations and cross sections of one, of the many mechanisms that may be integrated with the transdermal device. For example, illustrated in Figures 2 is microneedle technology, where various embodiments may choose to incorporate this instrument as a means to administer constituents that have difficulty, or are unable to be transferred to the subject through transdermal administration. Microneedles penetrate the different layers of the skin in order to release the stored contents, as shown in Fig 2C and 2D, with the major objective of penetrating the outmost layer of the skin, the stratum corneum.
Reuse of the patch, possibly including microneedle applicators may be possible in one or more embodiments, such that the constituents or treatment be refilled.

18 In Fig 3A to 3B, illustrates one or more embodiments that include designated sections of the transdermal patch for specific purposes and functions. Different materials that allow for different properties to be expressed may be favored in this situation. Different mechanism all in one patch for the predetermined constituents. These include, but not limited to, booster patch that is able to supply iodine from one region every 3 days, while vitamin D is sequestered onto a different section so that is may supply the body daily.
In Fig 4A to 4B, demonstrates a highly customizable transdermal patch that allows for desired regions or constituents to be individually removed, applied, and placed in a chosen area.
Generally a peel and stick mechanism is preferred by this mechanism, allowing for individual user selection of which, and when the constituents will be administered, at whichever location.
To demonstrate, for example, if a transdermal patch has the constituent vitamin D, iodine, and amino acids, specific segments may contain vitamin D and iodine separately, and another segments contain amino acids with microneedle technology. Since amino acids may require the use of microneedle technology, while vitamin D and iodine may not, selective placement and assignment of the constituents may allow for more desirable results.
In Fig 5A to 5D conveys one of more embodiments of a transdermal band, renditions of this mechanism depicts figures allowing for entire circumferential enclosure to semi enclosure.
Additional locking and stabilizing mechanism may be incorporated for more ideal application, such as, but not limited to tightening, fastening, convenience, speed, and easier removal and application. Many possibilities are possible for the closure apparatus, to list a few: Velcro, clasp, elastics, loop for passing excess band to tighten, and others. Therefore, this mechanism may be preferred during physical activity, or when consistent removal is expected, among the various other possibilities. Fig 5C displays a reusable band with refillable capsules, these capsules are loaded into the chamber on the band, therefore permitting reusability of the instrument.
In Fig 7A to 7B, one or more embodiments demonstrates a transdermal patch adopting a different shape, which may be ideal for certain situations and applications.
For example, the round nature of the device may be preferred when enclosing around a circular object, this may as well be used to indirectly suggest or instruct the user to apply the device in corresponding locations, such as an accompanying body that associates with the dimensions.
The user is limited to the options possible, as well as reduces the incorrect possibilities one may have selected. 7A depicts a semi enclosed form, 7B depicts a fully enclosed form, allowing for different levels of exposure and invasiveness.
In Fig 8A to 8B, one or more embodiments are shown to incorporate different functions and abilities, such that an additional utility is received from integrating a specific component. The combined mechanism of a transdermal patch, with an accessory function, such as an alluring scent, may attract a desired outcome or subject. Fig 8B illustrates one of many methods for determining the quantity or status of the usability and life of the device.
For example, an observable window, indicator, change in color, or various other alternatives may be used.
Therefore, the transdermal patch may incorporate one or more capabilities in a selected embodiment, such as expressed in the previous two examples.

19 ADVANTAGES ¨ SUBSIDIZED STRATEGIC DISTRIBUTION
Although the transdermal birth patch (TBP) was developed in order to address nutrient deficiencies in infants as well as encourage breasffeeding practices, there is also a possibility that the TBP can be further used to improve certain communities. This is accomplished through the controlled distribution of subsidized TBPs in specific regions, which can potentially boost productivity, increase GDP, reduce population growth rates, contribute to well-being, reduce health care expenditures, and provide many other benefits. If appropriate nutrition can be ensured for normal infant development and intellectual capacity, they can eventually contribute to the economy and become productive members of society. Access to subsidized TBPs could increase and prolong breastfeeding practices, this extends the time a mother is unable to ovulate due to the feedback mechanism of prolactin during lactation, thus lengthening the period between pregnancies. Since an interrelated issue observed by many families living in poverty, is their belief that additional members correlates to additional productivity and human capital.
Consequently, by indirectly encouraging longer pregnancy gaps will reduce the rate families grow in size, which can have an effect on a family member's access to resources, care, and attention ¨ all of which are generally limited and shared between the individuals. Therefore, by improving an individual's well-being, wealth, education and nutrition will lead to improved health status and development ¨ eventually joining the workforce as a productive member of society and contributing to the economy and GDP.
The concept being, in many areas of the world certain nutrients are not readily available or affordable, in order to acquire these nutrients through diet or through currently existing interventions would likely be cost prohibitive, if not impossible. By offering nutrients or treatment necessities which had not otherwise been accessible, at particularly no cost, encourages the use of the device, ideally to the completion of the therapy or during the immediate periods of development. The significant benefits received from the patch systemically encourages continual support for this device, if not create a forcing function for the use of the system. The TBP system, is partly comprised of a product that optimizes breastfeeding conditions as well as help the user reach the necessary nutritional concentrations, or physiological prerequisites appropriate to its needs. Therefore, this method will ideally help increase the number of individuals who breast feed their infants, as well as prolong the time they are breast fed.
This improvement in the length of time utilizing breastfeeding methodology is based on the assumption that many individuals would elect to prolong breastfeeding practices, so as to satisfy the conditions mandated for the subsidization of TBPs, which assists them in reaching enhanced physiological standards previously not achievable to them due to various limiting reasons. Therefore, the stipulations required to qualify for subsidized TBPs encourage individuals to breastfeed, as well as maximize the length of period breastfeeding, this aims to prevent or discourage consecutive pregnancies that happen without appropriate intervals between conceptions ¨ or at least extend the time the users receive nutritional and physiological improvements from the device and its associated engagements. Hence, individuals knowledgeable in the advantages of the device, can be predicted to opt for receiving treatment assistance essential to achieving developmental necessities, which otherwise were limited or

20 inaccessible to them. Proper implementation and successful adoption of the intervention, may require educating the community in the importance of producing healthy members of society that will be more productive than developmentally compromised individuals. To demonstrate, nurturing healthy offspring cultivate more intelligent, stronger, and useful family members to their advantage, than having additional members who are more inefficient and unproductive, while also requiring additional input of resources or medical setbacks.
In areas of overpopulation, by lengthening the time an infant breasffeeds will extend the time a mother is unable to ovulate due to the feedback mechanism of prolactin, which is released during lactation (Yoshimura, 1994). This prevents mothers from having recurrent pregnancies in resource limited regions, therefore, improving living conditions through mitigating competition and division of provisions ¨ consequently this could also have a resulting influence on the growth of the population. In regards to the malnourished mother, this delay creates a larger recovery window in which it is recommended to have between conceptions, but could also function to interrupt common cycles of declining infant conditions and birth predispositions.
For instance, nutritionally compromised pregnancies and immature adolescent pregnancies are common in certain communities, which become recurrent issues that may cause long term difficulties, particularly for the following generation, and which are likely to continuously repeat and become inherited. Therefore, females who become pregnant when they are not fully mature or physiologically developed, lead to irregular births and developmental abnormalities, this coincides with the infant who will likely be undernourished, improperly developed, and marginalized. Eventually, these underdeveloped or physically compromised infants develop to repeat the cycle, such that they become pregnant, ¨ commonly before reaching biological maturity ¨ as well as suffer from malnourishment and inaccessibility to required resources, or both. For example, since they are unable to provide for one generation, developmental abnormalities may occur, this deviation may affect an infant's proper development and induce continuous abnormal development in future generations and so on, becoming a repeating pattern of impediments ¨ this may also be due to nutritional deficiencies that commonly occur from one generation to the next. If they are not physically fit or appropriately developed, this may compromise the unborn infant even before birth, where it will be eventually exposed to additional environmental challenges. These reoccurring sequence of events and obstacles spawned from one generation to the next, are commonly observed in communities of the developing countries.
It is recommended that mothers space out pregnancies to every two years in order to reduce complications and developmental issues (Encyclopedia of Behavioral Medicine, 2013).
Incentive to breasffeed could function as a preventative preliminary strategy that results in the reduction of pregnancies in pubescent to prepubescent girls, as well as have effects on sequential pregnancies that do not follow the advised two year concurrent gap between prenatal periods. Therefore, a decline in pregnancies reduces the number of individuals contributing to the population size, allowing resources to be shared within a smaller number of people. Hence, by reducing population growth rates could have many significant results, such as an increase in available resources, opportunities, health per capita ¨ and over time, poverty, gender inequality, and slum dwellings could also be influenced (Mcgillivray, 2006; Veal, 2011).

21 This project was primarily designed to address nutrient deficiencies in infants while encouraging breast feeding practices through the application of the transdermal breasffeeding patches. If subsidized TBPs can also be provided in certain regions, we speculate it will also increase the well-being of the area, individuals, and the future of the developing society. By improving the health of the population and reducing malnutrition could eventually lead to an improvement in overall health status, the number of productive members of society, and show positive results in overall GDP and well-being. This would be achieved through the healthy growth of infants, and through the rise in the number and length of breast feeding practices ¨
resulting in more available resources, lower mortality numbers, and a reduction in population growth rates ¨ particularly in areas with high birth rates. If these results can be met, further improvements on poverty and inequality could potentially be observed.
ADVANTAGES
Infants predisposed to suboptimal development and inferior survival expectancies have become a prolonged condition that requires alternative interventions. During the initial period of a child's lifetime, the responsibility to ensure ideal conditions for optimal growth can significantly contribute to their expectations for survival in the future and their ability to appropriately develop.
It is also recommended by the World Health Organization that infants be exclusively breastfed for six months, without any additional food or drink ¨ including water.
Failure to do so could risk several complications, such as a reduction in breast milk production and the loss of numerous benefits breast feeding provides (World Health Organization, n.d.).
Although the maternal system as well as breast milk readily provides sufficient nutrients in appropriate quantities and quality in the average material individual living in the developed, or urbanized world, vitamin D is one of those exceptions. Past studies have shown that vitamin D
is readily diffusible through transdermal application and transferred into circulation (Alsaqr, Rasoully, & Musteata, 2015). Since vitamin D, A, E, K, B12, and iodine are fat soluble and of low molecular size and weight, implementation of these vitamins on TBPs would be similar in nature to vitamin D, and ideal for topical application, particularly when adapting the TBP for humanitarian uses, many cases that lack these specific nutrients (Alsaqr, Rasoully, & Musteata, 2015; Mandelbaum, 1942; Pirot, Panisset, Agache, & Humbert, 2009; Pyati, Ramamurthy, Krauss, & PiIdes, 1977).
The TBP was designed to address some of the difficulties and issues known to be present in currently existing products, while also offering additional advantages. Issues such as, but not limited to, contamination, environmental concerns, lack of diligence, and improper administration. In terms of health standards, an overall improvement can be observed regarding hygiene and maintaining sterile conditions, such that the TBP is least at risk to contamination due to not being susceptible to the predispositions existing in other interventions. For example, the TBP is not vulnerable to a solvent or solution that may be in danger of contamination, such as what is required when mixing infant formula with an impure solution. This may be commonly observed in communities without access to clean running water or improper handling and storage.

22 The adhesive patch is also not at risk to the condition of any tool or object used to administer or distribute the product, such as the cleanliness of any equipment used to reapply or administer the treatment. A disadvantage associated with using liquid droplet products, which require the use of a dropper measurement tool that is generally reused after each application.
Subsequently, the dropper applicator is likely to contact foreign surfaces and objects that may be predisposed to contaminants or hazardous elements. In the event that the dropper is contaminated with a substance, it may cause further issues by disseminating the substance into the treatment product when reapplying, storing, or contacting the treatment fluid (Drago, 2011).
Therefore, while the TBP is less at risk to foreign influences and more capable in providing hygienic conditions, the TBP is also able to offer additional advantages and improvements to the administration process. This may be achieved through, but are not limited to, improved consistency, accuracy, and control of the dose during administration. Such as, but not limited to the release of the constituents at a predetermined concentration during specified intervals, as well as various other applicable specifications desired by the user. Specifications and capabilities which can be adjusted to the needs of the user, primarily requiring fundamental adjustments, such as modification to the matrix, layers, transport agents, to name a few.
Consequently, the TBP is less prone to human errors, such as over or under administering the treatment. A concern in both fluid products such as liquid droplets, as well as infant formula ¨
particularly when mixing the appropriate amount of infant formula at the appropriate concentrations. The TBP addresses these issues regarding consistency and accuracy since it can be precisely and accurately regulated through the design and components of the patch (Cantrell & Hogen, 2015).
When the transdermal device is applied during lactation, it relies on the natural biological production of breast milk, milk that innately adjusts its own constituents to meet the requirements of the growing infant's needs. Any difficulty for a large population, or cohort group in reaching acceptable levels will have the advantage of being fortified by the clinical patch, this is conducted in a noninvasive manner that maximizes the benefits an infant or mother can achieve, particularly when compared to the other competing options currently offered. The exclusive benefits received from the consumption of biologically produced maternal milk, such as bioactive factors, can now be inclusive while also reinforcing the well-established and highly beneficial practice of breasffeeding ¨ the same advantages creating issues in competing products.
Although the transdermal adhesive can offer advantages unavailable in competing products, it is still able to provide the functions and capabilities offered by those opposing methods in the same capacity, if not greater. Any flaws observed in the prior art, including the complications and limitations existing in the interventions currently available for purchase, have been principally addressed, by either eliminating the issues, removing any prior obstacles, or improving the conditions by mitigating any inadequacies, to indicate a few ways.

23 CONCLUSION, RAMIFICATIONS, AND SCOPE
Many growing infants in the world suffer from malnutrition and improper feeding practices, this consequently affects their development, mortality, well-being, and capacity regarding mental and physical abilities ¨ leading to opportunity loss ¨ a forfeiture of potential individuals that could have become productive members of society, such that they have the ability to maximize contributions to the community (Gupta, Dadhich, & Sun, 2015). This issue can start with the malnourished mother, poor environmental conditions, food availability, government, societal constructs ¨ such as war, famine, tradition, and many others (Mcgillivray, 2006; Veal, 2011). These problems can be addressed through breasffeeding practices, nutrient supplementation, access to greater resources, better opportunities, reduction of poverty and inequality, among the many factors (Gupta, Dadhich, & Sun, 2015).
In order to combat these issues, the transdermal breastfeeding/maternal patch was proposed with a timeline and strategy to transition from the developed to the developing world.
This allows infants access to breast milk of higher quality, while increasing breasffeeding practices. In certain situations, it is able to encourage optimal spacing between pregnancies, therefore reducing the size of families in resource limited areas. Thereby, positively influencing one's access to available resources. This will contribute to the improvement in the health status of childbearing woman, as well as many other features that allow for improved well-being. The TBP also has the potential to provide benefits on a societal level based on the proposed strategy of distributing subsidized TBPs, this creates a rise in access to overall resources, opportunities, as well as a rise in an individual's abilities, productivity, and contribution that can cumulatively improve GDP. Overall, it will have a positive effect on the size of the community, level of poverty, and inequality to some extent. Therefore, the TBP and the strategic use of the product can potentially contribute to improving nutrient status of infants globally, encourage breastfeeding practices, and contribute to improving conditions in the developing world (Gupta, Dadhich, & Sun, 2015; Mcgillivray, 2006; Veal, 2011). Although other methodologies may also be appropriate for achieving results in the same capacity.
The TBP will also need to be adapted to the location and environmental conditions of the community to suit the deficiencies faced in the region. Although breast milk readily provides sufficient nutrients in appropriate qualities and quantities in the average lactating individual living in the developed and urbanized world, vitamin D is commonly one of those exceptions.
Therefore, to achieve our long term objectives, our initial goal may be to focus on addressing the needs of the surrounding region and continent, there are several advantages to progressing in this manner, as well as improve the chances of success. Such that, but not limited to, being more likely to produce higher returns to cover expenses, allow for improved accessibility and convenience, provide conditions that allow individuals to react faster and implement changes, offers the benefit of having a better understanding and awareness of the familiar territories, particularly when understanding data or gathering feedback, among the many other advantages.

24 To provide further clarification on some of the advantages mentioned, initial production is a key period of development when issues may need to be addressed promptly, such that human resources and appropriate measures must be readily available to oversee any complications, which is improved by better accessibility to the production facilities. Prior knowledge and familiarity with the demographic and community, help us to better evaluate and diagnose during the development processes. Therefore, ideally the initial objective is to focus on the more relevant and accessible groups, by developing and demonstrating successful applications of topical vitamin D from a transdermal patch. Although, other approaches to implementation are available, someone skilled in the art may rectify the situation appropriately, such as through changes in the region, constituents, manufacturing, and such.
Past studies have shown that vitamin D is readily diffusible through transdermal application and transferred into circulation (Alsaqr, Rasoully, & Musteata, 2015). In one or more embodiments, optimal placement and specifications of vitamin D on the breast, allow movement to the bloodstream, and into the milk lobules, in order to supply 400 Ul vitamin D. Since vitamin D, A, E, K, B12, and iodine are fat soluble and of low molecular size and weight, implementation of these vitamins on TBPs would be similar in nature to vitamin D, and ideal for topical application, particularly when adapting the TBP for humanitarian uses, many cases that lack these specific nutrients. Since the economic status of a community, commonly, but not always, reflect an individual's access to proper nutrition and growth, the diet of the population also changes due to the location. Therefore, it is not uncommon for different communities to lack different nutrients in breast milk, which may have properties incompatible with simple diffusion, thus different regions could require specialized TBPs or more novel transdermal methods, such as micro needle technology.
Although specific descriptions were used to help clarify and provide better understanding, these should not be taken as limitations on the scope, but used instead to convey and be offered as examples to the corresponding embodiment. Several other variations or modifications are also possible and able to exist, for example, dimensional changes regarding the various components and aspects obvious to the needs of a person skilled in the field may be exercised. Along with this change, a multitude of other differences can be incorporated, such as rearranging or exchanging parts from one location to another counterpart specific to the needs of the user or person familiar in the field. Since a final version of the product has not been confirmed, a multitude of changes may occur to best accomplish the benefits it may provide. The functions and expectations of the device may also change, such as providing relief, cooling sensations, preventative disinfectant and cleanse, herbal effects, reduce irritation, to list a few. This may also be applied to various regions, such as the chest, throat, back or other specific or unspecific area. Design and mechanical changes may also be implemented, radically changing any previously available structure, process, or mechanism. For example, adopting a device that may be reused, refilled, recharged, restarted, removed, or exchanged to list a few. Replaceable or refillable compartments could be possible, in conjunction with a more permanent device, vessel, band, attachment, or reusable dispensing or storage device. Incorporation of other features, abilities, or components may also be possible.
For example, the addition of microneedles to assist in movement.

25 Several potential embodiments may make alterations to the current existing components, such that certain aspects may be removed or adopted more significantly.
Numerous examples such as, but not limited to: through holes or transparent areas may be incorporated, along with symbolic or informative markings, primary or secondary functions, or the usability correspondingly. Many other variations that have not been stated, but obvious to a user skilled in the discipline, are also possible. Changes to the size, material, shape, color, attachment, connection or association with adjacent elements may be different.
These, as well as many other modifications dependent on the operational requirements, such as the adhesive mechanism, attachable substitute for adhesives, operational functions, and many others.
Different methods may also be possible, along with aspects regarding production, such as being manufactured integrally or separately, modular or in sections, to name a few.
Other limitations, such as, but not limited to convenience factors in existing interventions are improved in the adhesive patch, which may be applied and used for an extended period of time. As well, due to the weight, size, and compact nature of the TBP, added convenience is offered to the user in regards to storage and transportation requirements when compared to other currently offered methods (Higo, 2007). For example, infant formula is packaged as a dry powder in large volume containers, similar to protein powder. These large vessels can become quite bothersome and obstructing, hindering movement, transportation, and storage space availability, specifically when compared to the other interventions. In conjunction with the dimensional requirements present in infant formula, the powdered treatment is also significantly heavier than other leading products. Although liquid drops, for example, may be more confined in size and lighter in weight, it does suffer from a reduction in convenience, as well as involve more technical responsibilities, additional procedures and requirements, especially when taken in comparison. Therefore, since the TBP does not require large volumes of space, consistent attention and effort, extensive supervision, and has minimal procedures ¨ that are simple and direct ¨ while also being considerably light in weight, the TBP offers more ideal conditions and suggests a more superior intervention, particularly when taken in those respects. Hence, overall convenience and handling has been improved, and the TBP also introduces a significantly different methodology and novel technique to the currently available products on the market.
This approach to administrating and supplementing the mother through a topical process, which eventually supplies the neonate ¨ if unborn, the breastmilk ¨ when lactating, as well as the infant ¨ when it consumes the treated breastmilk, is a new method to providing treatment and supplementation in females and mothers, particularly when conceiving, pregnant, lactating, nurturing, and general purposes.
Although the TBP is generally applied to females or mothers, who need to reach a specific physiological status ¨ or are inefficient in certain components ¨, particularly at any time before and throughout the entire conception process, up until complete infant maturity. This clinical device may also be used during any period of a patient's life ¨ given the appropriate conditions and correct specifications ¨, particularly as a general dispensing, and storage vessel, with monitoring, and maintenance abilities, but are not limited to these functions and possibilities. The TBP can be applied to both male and female, or used fundamentally as a dispensing device to any object or condition, either on biological tissue or not.

26 Other ramifications are also possible, and are not limited to the items mentioned in this document, such as the placement of the device on the body, utilization or adaption of with another attachment, the target areas of the treatment and individuals, to achieve certain conditions for other needs or prerequisites (i.e. for certain medical procedures), can be done at any state of being or physiological condition, at any age or possible influencing condition, as well as many other extensive uses. Therefore, a person skilled the in art will be knowledgeable in the needs and modifications required. For example, any changes to the specifications, components, design, manufacturing, packaging, adoption of relevant methods, off-label uses, manual tampering or adjustments, the applicant or condition, the constituents, the life cycle or duration of effect, the time of day, the duration between applications, the length of time attached, the procedures or requirements, the materials, the form of the device, the cost, the vessel used, the production specifications, non-adhesive method of attachment, pharmaceutical needs or constituents, the purpose and effect desired, and many other different possibilities.
Current transdermal devices are generally designed to administer a drug or pharmaceutical compound, such as nicotine or steroids for clinical purposes, as well as administer constituents at a determined dosage. Transdermal devices designed and designated for a particular purpose or situation has rarely, if at all, been developed and made available ¨
especially for nutritional or overall wellness. Therefore, one or more embodiments are designed and developed to address certain situations, or provide a cumulative or overall effect, for example, and not limited: recovery patch, maintenance patch, prenatal patch, complete maternal patch, systemic prep patch, after birth patch, menopausal patch, pubescent patch, muscle recovery patch, rebuilding patch, workout patch, amino patch, focus patch, wakeup patch, patch to increase alertness, exhaustion patch, emergency patch, essential survival patch, diet patch, meal supplement patch, meal substitute patch, daily or weekly or monthly patch, to present a few possibilities.

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Project Proposal Transdermal Breastfeedmg Patch Benjamin Chiu University of British Columbia Table of Contents Introduction3 Motivation4 Additional Functions5 Project Summary8 Project Plan9 Project Details14 Concept and Mechanism14 Implementation Issues and Challenges15 Deliverables17 Timeline 18 Conclusion19 References21 Appendix23 I. Introduction Nutrient deficiencies with improper practices are common in growing infants and can have detrimental consequences to the development, health, and survival of the infant. Although the severity of the outcome is more prominent in developing societies, affluent countries equally face a concerning lack of breastmilk that meet the nutritional needs of a developing newborn (Gupta, Dadhich, & Sun, 2015). By addressing the dietary requirements of the growing neonate, as well as adopting breastfeeding methodology during this critical phase of growth can yield significant advantages (Gupta, Dadhich, & Sun, 2015). Breastfeeding, particularly when exclusively performed during the first six months provides numerous health and dietary benefits, especially if the milk offers appropriate nutritional content. Although being highly advised by the World Health Organization, the number of infants under six months that are exclusively breastfed still remain low in many regions of the world (Heymann, Raub, &
Earle, 2013).
Therefore, our objective is to provide a product which allows nutrient deficient infants in the world meet their nutritional requirements, while also providing a safe intervention that encourages the important practice of breastfeeding. In order to address both these issues, we have proposed the concept of the transdermal breastfeeding patch (TBP). This allows for the controlled release of various nutrients through topical application on the external breast tissue which will travel into the bloodstream, milk lobules, and breast milk ¨ our initial objective would be to achieve this function with Vitamin D. To better understand this method and our current progress, we will provide some background information, a project plan, and project details.

II. Motivation In many regions of the world, children fail to develop in accordance with the international growth chart or successfully reach maturity due to a lack of nutrition during critical periods of development. Without the adequate nutrients to meet an infant's needs, predisposes the individual to short stature, high risk of mortality, cognitive and physiological abnormalities, as well as many other ailments and susceptibilities. During the first 1000 days after conception, infants go through an important period of development which requires sufficient supplies of nutrients; failure to obtain adequate amounts significantly interferes with the health of the child as well as present many long term consequences.
Numerous communities and individuals in every country are currently facing issues with nutrient deficiency, dietary insecurity, food accessibility or availability, and nutritional instability. Without access to a diverse nutrient dense diet rich in micro and macronutrients pose significant complications, particularly for infants who rely on their mothers to provide breast milk in sufficient quantities and qualities (Gupta, Dadhich, & Sun, 2015). In many situations, it may not be directly related to dietary concerns, but primarily stemming from environmental causes, such as seasonal changes or geographical disadvantages. Vitamin D is an extreme case in which many individuals in the world are nutrient compromised, particularly in the urbanized or industrialized economies. Due to nutrient deficiencies in the breastfeeding mother, she will be unable to produce and supply the breast milk with appropriate nutritional content. Although breast milk is efficient in acquiring nutrients from the lactating mother, due to the state of nutrient deprivation or malnourishment, the integrity of the breast milk and infant are frequently compromised, therefore human intervention is required.

It has been well established through scientific research and The World Health Organization that infants should be exclusively breastfed for the first six months at minimum (World Health Organization, n.d.). This is recommended for numerous reasons, breast milk contains exclusive antibodies for the baby while significantly decreasing the infants risk for sudden infant death syndrome (SIDS), respiratory tract infections, asthma, allergies, as well as providing many other additional benefits (World Health Organization, n.d.).
Although there are numerous advantages to breastfeeding, the number of infants being exclusively breastfed are minimal in many areas of the world (Heymann, Raub, & Earle, 2013). In Canada, about one in four mothers breastfeed exclusively for the first six months, and globally, less than 40% of individuals under six months are exclusively breastfed (Statistics Canada, 2015; World Health Organization, n.d.). Therefore, by producing a method that can overcome any nutritional insufficiencies breast milk may have, while being able to utilize breastfeeding practices to meet the dietary needs of infants, coincided with nutrient supply to the adult mother will optimize the results. The transdermal breastfeeding patch seeks to achieve these objectives and more.
Additional Functions Although the transdermal breastfeeding patch (TBP) was developed in order to address nutrient deficiencies in infants as well as encourage breastfeeding practices, there is also a possibility that the TBP can be further used to improve certain communities.
This is accomplished through the controlled distribution of subsidized TBPs in specific regions, which can potentially boost productivity, increase GDP, reduce population growth rates, contribute to well-being, reduce health care expenditures, and provide many other benefits.
If appropriate nutrition can be ensured for normal infant development and intellectual capacity, they can eventually contribute to the economy and become productive members of society.
Access to subsidized TBPs could increase and prolong breastfeeding practices, this extends the time a mother is unable to ovulate due to the feedback mechanism of prolactin during lactation, thus lengthening the period between pregnancies. An issue seen in many families in poverty that carry the belief additional members correlates to additional productivity and human capital. Therefore, this will influence the size of families, which can have an effect on an individual's access to resources, care, and support previously being divided, leading to improved health status and development ¨ eventually joining society as a productive member of society.
The concept being, in many areas of the world certain nutrients are not readily available and affordable, in order to acquire these nutrients through food or with current supplementation methods would be expensive if not impossible (Mcgillivray, 2006). By offering nutrients, which had not otherwise been available, and particularly at no cost, creates a forcing function to adopt this option. The TBP, which function only during breastfeeding, can therefore increase the percentage of breast fed infants AS WELL as prolonging the time they are breast fed. This rise in breastfeeding duration would increase due to the assumption that mothers elect to prolong breastfeeding ¨ and forgo pregnancy ¨ at least until breastfeeding is maximized. This is favored in order to supply and capitalize on essential developmental nutrients previously limited to them.
This will be acknowledged through educating the public in the short run, and raising healthy, contributing family members whom will provide more advantages than many unproductive members comparatively.
In areas of overpopulation, by lengthening the time an infant breastfeeds will extend the time a mother is unable to ovulate due to the feedback mechanism of prolactin, which is released during lactation (Yoshimura, 1994). This prevents mothers from having recurrent pregnancies in resource limited regions, therefore improving living conditions through mitigating competition and division of provisions ¨ consequently could also influence the growth of the population. In regards to the malnourished mother, it creates a larger recovery window in which they need, but could also function to interrupt the cycle of premature adolescent pregnancies that leads to irregular births and developmental abnormalities, this coincides with the infant who will likely be undernourished and marginalized. Eventually, these infants grow to repeat the cycle, such that they become pregnant before reaching biological maturity, suffer from malnourishment, or both.
They are not physically fit or appropriately developed, compromising the unborn infant even before delivery where it will be exposed to tremendously more environmental challenges. This repeating sequence of events and the obstacles generated from this behavior are commonly observed in communities in the developing countries.
It is recommended that mothers space out pregnancies to every two years in order to reduce complications and developmental issues (Encyclopedia of Behavioral Medicine, 2013).
Incentive to breastfeed could function as a preventative preliminary strategy that results in the reduction of pregnancies in pubescent to prepubescent girls, and/or sequential pregnancies that do not follow the advised two year concurrent gap between prenatal periods.
Therefore, a decline in pregnancies reduces the number of individuals contributing to the population size, allowing more resources to be shared within a smaller number of people. Hence, by reducing population growth rates could have many significant results, such as an increase in available resources, opportunities, health per capita ¨ and over time, poverty, gender inequality, and slum dwellings could also be influenced (Mcgillivray, 2006; Veal, 2011).

III. Project Summary This project was primarily designed to address nutrient deficiencies in infants while encouraging breast feeding practices through the application of the transdermal breastfeeding patches. If subsidized TBPs can also be provided in certain regions, we speculate it will also increase the well-being of the area, individuals, and the future of the developing society. By improving the health of the population and reducing malnutrition could eventually lead to an improvement in overall health status, the number of productive members of society, and show positive results in overall GDP and well-being. This would be achieved through the healthy growth of infants, and through the rise in the number and length of breast feeding practices;
resulting in more available resources, lower mortality numbers, and a reduction in population growth rates ¨particularly in areas with high birth rates. If these results can be met, further improvements on poverty and inequality could potentially be observed.
Our primary objective would be to first confirm and formally demonstrate that the TBP
can provide a breastfeeding mother with appropriate nutrients, this would be initially verified with Vitamin D due to its favorable properties and additional conveniences allowable for scaling purposes. The secondary objective would be to market and produce the TBP in the domestic market before releasing to foreign markets. This would be to capitalize on the differences in the deficiencies commonly observed from different regions, as well as to provide profit margins allowable to support a targeted resuscitation plan in struggling communities.
Once the secondary objectives can be achieved, the production and distribution would be scaled up along with the subsidized, and more advanced, appropriate TBPs to the growing number of strategic areas that can adopt the TBP support model on a global scale.

IV. Project Plan In order to finance and supply transdermal breastfeeding patches in struggling communities and areas of poverty, costs will be offset through TBP purchases made from the more industrialized regions, such as the first world countries. Any profits made will be directly diverted to this cause. The TBP will also need to be adapted to the location and environmental conditions of the community to suit the deficiencies faced in the region.
Although breast milk readily provides sufficient nutrients in appropriate qualities and quantities in the average lactating individual living in the developed and urbanized world, vitamin D is one of those exceptions. Therefore, to achieve our objectives, our initial goal is to focus on this market by developing and demonstrating the successful application of topical vitamin D
from a transdermal patch.
Past studies have shown that vitamin D is readily diffusible through transdermal application and transferred into circulation (Alsaqr, Rasoully, & Musteata, 2015). We would like to run trails to confirm these findings, as well as to assess optimal placement and specifications of vitamin D on the breast, to the bloodstream, and into the milk lobules, in order to supply 400 UI vitamin D (Furman, 2015). Since vitamin D, A, E, K, B12, and iodine are fat soluble and of low molecular size and weight, implementation of these vitamins on TBPs would be similar in nature to vitamin D, and ideal for topical application, particularly when adapting the TBP for humanitarian uses, many cases that lack these specific nutrients (Alsaqr, Rasoully, & Musteata, 2015; Mandelbaum, 1942; Pirot, Panisset, Agache, & Humbert, 2009; Pyati, Ramamurthy, Krauss, & Pildes, 1977). Since the economic status of a community, commonly, but not always, reflect an individual's access to proper nutrition and growth, the diet of the population also changes due to the location. Therefore, it is not uncommon for different communities to lack different nutrients in breast milk, which may have properties incompatible with simple diffusion, thus different regions could require specialized TBPs or more novel transdermal methods, such as micro needle technology.
There are currently two main methods used to address vitamin D deficiencies in breast milk, vitamin D supplementation using liquid drops or a breastmilk substitute through formula feeding. Both forms of addressing the vitamin D complication comes with their own shortfalls and obstacles, each affecting the integrity or benefits received by the infant or breastfeeding mother. Liquid drops are known to have many documented cases of rejection and distaste from infants, primarily due to the sensitive taste and smell of the newborn. It is also subject to high risk of human error and misuse, predominantly with dosages and incorrect amounts given to the child. Compliance issues with high rates of failure to administer consistently, and at the required times, are frequent issues of liquid drop users. Improper application and lack of use can be attributed to the inconvenience and daily tediousness offered by this method.
Formula feeding is substantially inferior to breast milk but can have the false pretense to be superior in nature. It is inferior in quality, substance, function, safety, and efficiency, while being at the risk to the quality or contamination of the solvent.
The TBP was designed to address some of the difficulties and issues known to be present in the other methods, while also offering additional advantages. In terms of a comparatively hygienic and sterile alternative to both methods, TBP would not be susceptible to a solvent or mixing solution that can often be tainted or subjected to the quality of a complementary component, observed in formula feeding and unclean water. It is also not liable to a method that require recycling of equipment that can further spread and contaminate the vitamin D solution, such as the refilling of the dropper after contact with foreign contaminants (Drago, 2011). While also offering sanitary benefits, TBP would be able to provide additional improvements in administration, with a more consistent and controlled release of dosages that can be adjusted or adapted to one's needs through simple changes to the constituents (Cantrell &
Hogen, 2015).
Therefore, it is not predisposed to the human errors of under or over administration observed in liquid drop users, but is tightly regulated by the design of the patch itself.
Due to the various off-label administration techniques consumers have been known to use ¨ direct mouth application, dissolvent into pumped breast milk, perimeter application of the nipple, etc., liquid drops are more prone to improper practices. Intestinal and digestive gas buildup, along with upset stomach are a few of the side effects observed in infants administered with this particular method. Also, due to the direct application or lack of constituents that can limit the strength of the exposure, infants may have a strong aversion or rejection for vitamin D
drops as well (Baby Center, 2013). TBP offers an intuitive and straightforward peel-and-stick procedure that is applied to the breast of the lactating mother, it does not require any process or component to be performed, or in exposure to the infant. As well, due to the weight, size, and compact nature of the TBP, added convenience is offered to the user in regards to storage and transportation when compared to other currently offered methods (Higo, 2007).
Daily administration of vitamin D drops at suggested intervals are also not required for TBP users, the TBP can be engineered and customized to provide the controlled release of a specified amount of substrate in a desired interval or period of time, such as a week, therefore offering additional convenience and improvements by reducing the hassle or required work of other methods (Higo, 2007). Although liquid drops may offer a slight cost incentive when manufacturing is considered, the production expenses does not appear to have extenuating differences overall. It is also recommended by the World Health Organization that infants be exclusively breastfed for six months, without any additional food or drink ¨ including water. Failure to do so could risk several complications, such as a reduction in breast milk production and the loss of numerous benefits breast feeding provides (World Health Organization, n.d.).
Formula feeding is beset with numerous drawbacks and disadvantages that come at the consequence and detriment to the infant and lactating mother. This includes the absence of antibodies intended to be transferred by the mother when breastmilk is consumed, this biologically produced constituent cannot be synthetically created and results in many complications and health risks when appropriate levels are not achieved. An increased risk of Sudden Infant Death Syndrome has also been consistently correlated to the rise in substitute feeding methods and the reduction of breast feeding practices. In conjunction with improper physiological and neurological development, Formula feeding comes at the expense of a compromised immune system, high opportunity costs, and several more impediments (Cattaneo, 2007; Drago, 2011).
Although Formula may contain all the essential nutrients an infant requires, it cannot adapt to the specific needs ¨ that is consistently changing ¨ in a growing infant, a function present in breastmilk. For example, the lactating individual physiologically changes and adjusts the quantity and quality of nutrients an infant needs during feeding (Cattaneo, 2007). The milk producing body is sensitive and acute to the requirements of the baby, by using this system as a tool to yield the proper dosage and amount allows for optimal consistencies an infant requires (Cattaneo, 2007). Instead, the content of Formula is restricted to a generalized amount for each nutrient that serves as the standard quantity regardless of any changes to the infant. However, this substitute feeding method is able to provide adequate amounts of Vitamin D, a property absent in many breast feeding mothers in the developed and developing countries. Therefore, Formula is often chosen and relied upon for this particular advantage ¨ the ability to deliver required nutrients at acceptable levels. Conversely, the TBP can replicate this competitive advantage and appeal of Formula, while also improving and incorporating practices beneficial to the population, among many other abilities.
Oral supplementation is also another commonly practiced method currently used to provide and supplement the required amount of nutrients, particularly vitamin D, to the breastfeeding infant. This approach is also prone to many disadvantages and safety concerns in both the lactating individual and the feeding infant. Two methods currently exist for oral supplementation, either selecting to boost the nutrient in the mother ¨
assuming that it will increase the availability in the blood content to be transferred into the breast milk; or to apply to the child through direct or indirect procedures. Selecting to increase the nutritional content in the circulation of the lactating person usually requires extremely high daily doses at consistent intervals, this is prone to many detriments as well as the disadvantages previously outlined.
Depending on the first pass effect, the composition, and specifications of the nutrient, the nursing mother may need to consume more than 16 times the amount in order to provide the necessary levels required, such as for vitamin D, 6400UI of vitamin D is needed to provide 400 UI in the breastmilk (Furman, 2015). Direct supplementing techniques on the infant has many concerns regarding compliance, aversion, taste, and numerous other omitted benefits.
There has been many documented cases of infants that withdraw from feeding due to the taste applied to the nourishment or perimeter of the feeding area.
The TBP solely relies on the natural biological production of breast milk while only altering the content to the growing infant's advantage, this is accomplished in a noninvasive process that maximizes the benefits an infant or mother can possibly achieve in any method currently offered. The exclusive properties only available in the natural production of milk can now be reinforced and included as part of a method, and the appeal and exclusive utilities of any competing methods has also been incorporated, if not improved. Any setbacks or shortfalls in any current practice has also been addressed.
V. Project Details Concept and Mechanism The mechanism for the transdermal breastfeeding patch relies on the ability of certain nutrients to passively diffuse through the epidermal layers of the skin and into the milk-producing lobules via topical application. The non-diffusible or hard-diffusible nutrients can be transported across using certain transporters, or with the assistance of proprietary transdermal techniques and technology (Alsaqr, Rasoully, & Musteata, 2015; Mandelbaum, 1942; Pirot, Panisset, Agache, & Humbert, 2009; Pyati, Ramamurthy, Krauss, & Pildes, 1977).
Transdermal patches is an adhesive attached to the skin that releases controlled substances, usually through a porous membrane or through body heat dissolving thin layers of substance embedded on the adhesive or on different layers of the patch (Higo, 2007).
The TBP method will utilize the construction of a proprietary adhesive applied to the lactating individual, generally on the breasts, close to or adjacent to the nipple optimizing diffusion of nutrients into the breast milk. This will supply the nutrients to the infant upon consumption, and will also supply nutrients into the circulatory system of the lactating individual. This method primarily functions during breastfeeding and is used to provide nutrient supplementation but can also be altered to carry applicable medication to the requirements of the infant via the consumption of breast milk.

Implementation Issues and Challenges In order to determine the efficacy and specifications of the TBP, clinical trials and analysis would need to be conducted. Data and breast milk samples would need to be gathered before-and-after the application of the TBP to determine if significant results and information can be drawn from this method; other important determinants include optimal conditions, design, and application procedures. Conducting and gathering experimental data in an appropriate, controlled, and ethical process in an academic environment are current predispositions of the project due to the limited experience and knowledge of the members. Without proper supervision and mentorship could, and most likely will, produce inaccurate, unacceptable, and discouraging results with poor developmental outcomes of the product. Access to resources and analytical equipment are financial setbacks that could pose to be issues during the trial and developmental phases of the project. Gathering and examining qualifying participants, particularly vitamin D
deficient women who are lactating, could be potential challenges if insufficient time and attention is used to address and accommodate the seasonal changes during the year. Therefore, the efficacy and success of the project and product is time prohibitive and dependent on the productivity of the time allocated to the development and completion of the TBP. If successful and promising results are achieved, difficulties could also arise during the manufacturing and production processes due to minimal experience and exposure to the requirements and standards of the industry.
The transdermal breastfeeding patch proposes a method unique in the infant, health, and clinical/pediatric care field. Although many studies support and confirm findings that form the basis, efficacy, and scope of the TBP, exclusive experimental results directly addressing concepts relating to the processes are limited or have not been published to our knowledge.

Currently, there is a lack of research and academic literature pertaining to the notions and mechanics suggested by the TBP. Therefore, although experimental research and trials are required and essential in the development of the TBP, it also has an academic and scientific value as well; from the findings it also provides an opportunity to contribute novel data and literature for peer review. This product has the potential to introduce a unique approach to addressing nutrient deficiency, while also allowing for the discovery of new scientific insights.
Studies have been conducted on topical applications and the effect it has on the circulatory system or epidermis, but diffusion into certain organs is still novel and appears to lack significant academic insights.
In order to successfully conduct, develop, and gather scientific data, we hope to work with you throughout the rest (or at least parts) of this project. Your guidance, knowledge, and expertise in this discipline and its related fields will prove to be instrumental to our needs. After reviewing your contributions in the academic and clinical field, as well as your involvement in global and international initiatives, your work greatly aligns with our ideals and the goals of this project as well. We are highly motivated and determined individuals who are willing to learn and adapt to whatever the needs may be in order to successfully contribute and be a part in finding solutions to issues faced by communities around the world.

Deliverables Upon successful completion, the project will produce experimental data, knowledge on the optimal design and application of TBPs for production, along with insight into the timeline and strategy to supply and produce subsidized TBPs for regions that can most benefit from this device. If promising results are observed, additional steps can be made to patent and trademark the TBP so that any profits made from this product will be entirely diverted to philanthropic needs. These include offsetting the costs for producing and supplying patches to developing communities, areas of need, or struggling individuals. Scientific data can also be gathered from the observations and published in areas of breastfeeding, clinical, nutritional, pharmaceutical methods, global, medical research, and other fields that apply.
Among the deliverables already listed, the project also allows for members to be part of something great (potentially) that can do a lot of good (potentially). The opportunity to be involved in any initiative that can save a life should enough of a reward already, but in the likelihood that any benefit in terms of a financial or business gain through the creation or cause of the TBP, should be an unexpected accessory reward from the efforts of trying to accomplish the primary objective of the project, but not as the primary objective itself.

Timeline We hope to conduct trials as early as possible and be able to conduct a subsequent set of experimental trials by the beginning, and middle of summer if improvements and changes are required. Long term data could also be gathered in order to confirm that there is no evidence or indication of having any adverse effects or any associated complications.
Until modifications and improvements are not necessary, we can then move forward with the production and commerce of the TBP. Consumer feedback and responses would also be significantly important in refining and optimizing the TBP as it adapts to changes throughout its existence.
As stated previously, by prioritizing vitamin D and expediting its commercialization before any other nutrients, reduces risk and creates the opportunity to mitigate any adverse losses. This is due to the prevalent deficiency of vitamin D and the ability for the TBP to supplement breastfeeding mothers in the domestic and wealthier communities, it creates additional security and flexibility when proceeding with other projects and initiatives. This would be particularly visible once the humanitarian initiative to distribute subsidized TBPs is in progress.

VI. Conclusion Many growing infants in the world suffer from malnutrition and improper feeding practices, this consequently affects their development, mortality, and mental and physical abilities ¨ leading to opportunity loss ¨ loss of potential in individuals to become productive members of society and/or the ability to maximize contributions to the community (Gupta, Dadhich, & Sun, 2015). This issue can start with the malnourished mother, poor environmental conditions, food availability, government, societal constructs ¨ such as war, famine, tradition, and many others (Mcgillivray, 2006; Veal, 2011). These problems can be addressed through breastfeeding practices, nutrient supplementation, access to greater resources, better opportunities, reduction of poverty and inequality, among the many other factors (Gupta, Dadhich, & Sun, 2015).
In order to combat these issues, the Transdermal Breastfeeding Patch was proposed with a timeline and strategy to transition from the developed to the developing world. This allows infants access to breast milk of higher quality, while increasing breastfeeding practices. In certain situations, it is able to encourage optimal spacing between pregnancies, therefore reducing the size of families in resource limited areas. Thereby, positively influencing one's access to available resources. This will contribute to the improvement in the health status of childbearing woman, as well as many other features that allow for improved well-being. The TBP also has the potential to provide benefits on a societal level based on the proposed strategy of distributing subsidized TBPs, this creates a rise in access to overall resources, opportunities, as well as a rise in an individual's abilities, productivity, and contribution that can cumulatively improve GDP. Overall, it will have a positive effect on the size of the community, level of poverty, and inequality to some extent. Therefore, the TBP and the strategic use of the product can potentially contribute to improving nutrient status of infants globally, encourage breastfeeding practices, and contribute to improving conditions in the developing world (Gupta, Dadhich, & Sun, 2015; Mcgillivray, 2006; Veal, 2011).

VII. References Alsaqr, A., Rasoully, M., & Musteata, F. M. (2015). Investigating Transdermal Delivery of Vitamin D3. AAPS PharmSciTech, 16(4), 963-972. doi:10.1208/s12249-015-0291-3 Breastfeeding. (n.d.). Retrieved February 15, 2017, from http://www.who.int/maternal_child_adolescent/topics/child/nutrition/breastfeedi ng/en/
Cantrell, L., & Hogen, E. (2015). Vitamin D overdosage in an infant from nonprescription vitamin D drops. American Journal of Health-System Pharmacy, 72(15), 1262-1263.
doi:10.2146/ajhp150191 Cattaneo, A. (2007). The benefits of breastfeeding or the harm of formula feeding? Journal of Paediatrics and Child Health, 44(1-2), 1-2. doi:10.1111/j.1440-1754.2007.01263.x Drago, R. (2011). The WIC Program: An Economic Analysis of Breastfeeding and Infant Formula. Breastfeeding Medicine, 6(5), 281-286. doi:10.1089/bfm.2011.0070 Furman, L. (2015). Maternal Vitamin D Supplementation for Breastfeeding Infants: Will it Work? Pediatrics, 136(4), 763-764. doi:10.1542/peds.2015-2312 Gupta, A., Dadhich, J., & Sun, S. (2015). Infant Malnutrition/Breastfeeding*.Reference Module in Biomedical Sciences. doi:10.1016/b978-0-12-801238-3.03061-0 Health at a Glance: Breastfeeding Trend in Canada. (2015, November 27).
Retrieved February 15, 2017, from http://www.statcan.gc.ca/pub/82-624-x/2013001/article/11879-eng.htm Heymann, J., Raub, A., & Earle, A. (2013). Breastfeeding policy: a globally comparative analysis. Bulletin of the World Health Organization, 91(6), 398-406.
doi:10.2471/blt.12.109363 Higo, N. (2007). Transdermal Drug Delivery System. The Recent Trend of Transdermal Drug Delivery System Development. ChemInform, 38(32). doi:10.1002/chin.200732279 Mandelbaum, J. (1942). Absorption Of Vitamin A Through Human Skin. Archives of Dermatology, 46(3), 431. doi:10.1001/archderm.1942.01500150097012 Mcgillivray, M. (2006). Inequality, Poverty and Well-being. Inequality, Poverty and Well-being, 1-7. doi:10.1057/9780230625594 1 Pirot, F., Panisset, F., Agache, P., & Humbert, P. (2009). Simultaneous Absorption of Copper and Zinc through Human Skin in vitro. Skin Pharmacology and Physiology, 9(1), 43-52.
doi:10.1159/000211389 Pregnancy Spacing. (2013). Encyclopedia of Behavioral Medicine, 1529-1529.
doi:10.1007/978-Pyati, S. P., Ramamurthy, R. S., Krauss, M. T., & Pildes, R. S. (1977).
Absorption of iodine in the neonate following topical use of povidone iodine. The Journal of Pediatrics, 91(5), 825-828. doi:10.1016/s0022-3476(77)81052-4 Ten facts on breastfeeding. (n.d.). Retrieved February 15, 2017, from http://www.who.int/features/factfiles/breastfeeding/en/
Yoshimura, Y. (1994). Prolactin inhibits ovulation by reducing ovarian plasmin generation. Biology of Reproduction, 50(6), 1223-1230.
doi:10.1095/biolreprod50.6.1223 Veal, A. (2011). The spirit level: why more equal societies almost always do better. Leisure Studies, 30(3), 375-378. doi:10.1080/02614367.2010.543266 Vitamin D supplement, spitting up and colic. - February 2013. (n.d.).
Retrieved February 15, 2017, from http://www.babycenter.ca/thread/247423/vitamin-d-supplement-spitting-up-and-colic Appendix Condition % Lower Risk Duration of Breastfeeding Otitis Media 23 Any Otitis Media 50 At least 3 or 6 months Recurrent Otitis Media 77 Exclusive BF for at least 6 months Upper respiratory tract infection 63 Exclusive BF more than 6 months Lower respiratory tract infection 72 At least 4 months exclusive BF
Lower respiratory tract infection 77 Exclusive BF at least 6 months Asthma 40 At least 3 months, if with family history of atopy Asthma 26 At least 3 months, no family history of atopy RSV bronchiolitis 74 At least 4 months NEC 77 In preterm infants fed exclusively with human milk during their NICU
stay Atopic dermatitis 27 More than 3 months exclusive BF, no family history of atopy Atopic dermatitis 42 More than 3 months exclusive BF, with family history of atopy Gastroenteritis 64 Any breastfeeding Inflammatory bowel disease 31 Any breastfeeding Obesity 24 Any breastfeeding Celiac disease 52 More than 2 months Type 1 diabetes 30 More than 3 months exclusive BF
Type 2 diabetes 40 Any breastfeeding Leukemia (Acute Lymphocytic) 20 More than 6 months Leukemia (Acute Myeloid) 15 More than 6 months SIDS 36 Any breastfeeding beyond 1 month Chart 1: Simplified American Academy of Pediatrics Dose-Response Benefits of Breastfeeding Source:hnps://drzeka.fi les.wordpress.com/20 1 3/09/dose-response-benefits-of-breastfeedingl .png . -I
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Claims (9)

27l claim:

1. A storage and dispensing device with the means of administering constituents prior to, and during biological development, comprising:
a. a topically applied adhesive, or component with the means of attaching to an individual or eligible surface b. a constituent, or constituents, that is able to provide nutritional, clinical, or other desired functions when incorporated on the device, or when transferred to an individual c. a storage enclosure or said adhesive that allows for a means to hold and transfer said deposited constituents from said enclosure to the area of administration whereby said constituents is transferred using transdermal delivery or by similar means to the user, whom may further transfer said constituents to another repository, being, or other body directly or indirectly.

2. A storage and dispensing device as in claim 1, wherein said constituents and function is administered for prenatal, perinatal, postnatal, personal, or similar and related periods of need, through the user or other associated means, a. a storage and dispensing device as in claim 2, wherein said transdermal device is of proper size to accommodate an individual accordingly, as well as any constituents involved, such as for permeation, controlled release, and accompanying tasks, b. a storage and dispensing device as in claim 2, wherein an integrated instrument or said casing allows for a means to transfer said constituents from the device to the intended region more proficiently and desirably.

3. A storage and dispensing device as in claim 1, wherein the device comprises of additional components in appropriate specifications, which provide protective, mechanical, clinical, and other functioning means.

4. A method for treating a fetus, infant, or developing organism suffering from nutritional, developmental, clinical, or qualified compromising conditions administering the storage and dispensing device of claim 1.

5. A storage and dispensing device as in claim 1, wherein the device may be applied and modified to individuals, organisms, objects, surfaces, or applicable subjects outside the scope of biological development, but during any and all situations, for any given purpose.

6. A storage and dispensing device with the means of administering constituents using transdermal delivery for the purpose of maintaining, or improving an individual's nutritional wellness, and overall health condition, comprising:
a. a topically applied adhesive, or component with the means of attaching to an individual or eligible surface b. a constituent, or constituents, that is able to provide nutritional, clinical, or other desired functions when incorporated with the device, or when transferred to an individual c. a storage enclosure or said adhesive that allows for a means to hold and transfer said deposited constituents from said enclosure to the area of administration whereby said constituents is transferred using transdermal delivery, or by similar means to the user, whom may further transfer said constituents to another position, organism, or other element directly or indirectly

7. A storage and dispensing device as in claim 6, wherein the device may be modified and produced for an defined purpose, such as, but not limited to: a specific situation, function, period, action, activity, or condition, to list a few.

8. A transdermal device applied prior to, during, or after conception, pregnancy, birth, breastfeeding, infant maturity, or other related processes, in order to supply the maternal system with the stored constituents, comprising:
a. an adhesive module, or other component with the means of attaching to an individual or desired surface, b. a constituent, or constituents, that is able to improve the well-being of the user or associated component in a manner determined by the specifications of the device c. a vessel or compartment that allows for a means to store and dispense said constituents to the attached area whereby, said constituents is transferred using transdermal delivery in order to supply the maternal system with the deposited constituents, which may further relocate said constituents to another placement, being, or applicable body directly, or indirectly.

9. A storage and dispensing device as in claim 8, 6, and 1, wherein the device may be modified so that specific constituents have been compartmentalized appropriate to the design and needs of the device a. a storage and dispensing device as in claim 9, wherein the compartments may be detachable for selective application of the device