Not applicable
1. Field
The present invention is in the field of personal accessories such as jewelry, with the added incorporation of micronutrients.
2. Description of the Problem
In the prior art there are numerous non-medical devices and methods claimed to be beneficial to “wellness”, including many that place magnets in contact with various parts of the human body. There is no proven benefit from the use of such items, except that users respond that they feel better, resulting from the placebo effect, which is well known in science. While magnets may provide a placebo effect, they do not have the ability to meet real medical or nutritional needs. There are no deficiencies related to magnetism that can cause medical or nutritional consequences.
The human biochemical system, like the systems of other animals and plants, depends upon a diet that provides energy and tissue building materials called “macronutrients”, plus several dietary ingredients that are required in very small quantities and therefore are called “micronutrients”. Though the generally accepted Minimum Daily Requirement for micronutrients in adults is measured in milligrams or micrograms, deficiencies in these substances can cause significant medical problems. Some micronutrients are vitamins, which are essential to general health and help avoid specific and sometimes deadly medical problems. Some micronutrients are minerals, which are also critically important to the human metabolism. Some of those critically important mineral micronutrients are metals. Examples of micronutrient metals and the result of deficiencies are set forth in Table 1 below.
These and other micronutrient problems have been generally uncommon because a normal western diet includes an adequate supply of such micronutrients, usually from plant sources. That is also true for common vitamins; deficiencies have been rare among those with a normal western diet. However, modern western society increasingly adopts highly processed food that can be rapidly prepared and consumed, and research has shown that as the human diet shifts to such foods the possibility of deficiencies grows.
3. Toxicity
While vitamin pills and other dietary supplements usually provide the common vitamins required to avoid most deficiencies caused by poor dietary habits, many such products fail to meet the need for metallic micronutrients.
Some micronutrient metals become toxic when ingested in large quantities, and some misinformed consumers gulp large quantities of vitamin pills daily, so that toxicity is one of the reasons why those who formulate typical “vitamin pills” tend to avoid the use of potentially toxic metal content. Some consumers ingest hundreds of times the Recommended Daily Allowance of certain vitamins such as Vitamin C, even against the advice of the product label and their physicians. Fortunately, Vitamin C is water-soluble and does not build up in the body. Unfortunately, vitamins such as Vitamin A are fat-soluble and can build up in the body to potentially toxic levels.
There is no practical way to provide ingestible metals as micronutrients while eliminating the risk of toxicity among consumers who believe that “more is better” and “still more is better yet.” Most micronutrient metals can be toxic in large quantities.
For each micronutrient (whether a vitamin or mineral, including metals) there is a daily intake range that satisfies the body's requirement, and a point at which toxicity occurs. Between those two limits is a range that for most people is acceptable, potentially useful, and safe. However, it is well-established that deficiencies exist, and the curve defining dosage vs. deficiency is such that in some human subjects very small quantities of additional micronutrients, including metals, can have a significant health benefit.
4. Placebo Effect
There exist many jewelry products that contain magnets, and are sold as “beneficial to health”. There is no credible evidence that such “wellness” products offer any health benefit. There has never been reproducible research showing correlation between magnet-bearing jewelry/clothing/mattresses, etc. and health, yet consumers buy such products and report feeling better—apparently due to some derivative of the ‘Placebo Effect”. Even more significant, there is no known medical condition resulting from the absence of the static magnetic fields generated by such products. On the other hand, deficiencies in metal micronutrients have predictable, quantifiable, and diagnosable medical results. This comparison differentiates the present invention from personal accessories that incorporate magnets.
It is no surprise to behaviorists that the Placebo Effect functions even when magnet-bearing jewelry is worn by people with technical backgrounds. Most people who expect a result, achieve it. It appears that humans aggressively seek reasons to feel better, to perform better. That is so even when science and common sense converge on the impossibility of a device or remedy producing positive results.
5. Objectives
One objective of the present invention is to provide users with “health-promoting” personal accessories, including jewelry, that both exploit the Placebo Effect and potentially provide a real and tangible health benefit.
Another objective is to provide physiologically safe means for delivery of metal micronutrients at a safe delivery rate.
Another objective is to provide economically viable products that accomplish said deliveries.
Another objective is to provide a means by which small quantities of micronutrient metals can be transferred to tissues with a reduced probability of toxicity.
Another objective is to provide means by which micronutrient metal payloads can be modified in response to adverse reactions.
The present invention provides jewelry and other accessory items that ordinarily are in contact with the skin, that contain, are made of, or have a surface providing a payload of selected micronutrients, each in a form that can permit transfer of said micronutrients to the skin tissues.
There exist many jewelry products in the marketplace that contain magnets, and are sold as “beneficial to health”. There is no credible evidence that such products offer any health benefit. There has never been reproducible research showing correlation between magnet-bearing jewelry/clothing/mattresses, etc. and health, yet consumers buy such products and report feeling better—apparently due to some derivative of the ‘Placebo Effect”. It is no surprise to behaviorists that the Placebo Effect functions even when magnet-bearing jewelry is worn by people with technical backgrounds. Most people who expect a result achieve it. It appears that humans aggressively seek reasons to feel better, to perform better. That is so even when science and common sense converge upon the impossibility of positive results from some device, food supplement, or remedy.
The instant invention is not only a stimulant of the Placebo Effect, but works on the probability that when micronutrient metals come in contact with the skin there can be a finite transdermal absorption of micronutrient metals in the form of elemental metals, metal oxides, or metal salts. For example topical magnesium is absorbed through the skin, as is the payload of many medical patches. In fact, many substances do pass into the body from the outer surface of the skin into the circulation. To understand how this works, imagine a tightly woven fabric. While from a distance it may appear impervious, at close range it is actually highly porous. It is this porous nature of the skin, with its millions of tiny openings, that allows not only sweat and toxins to escape, but also enables the absorption of some substances. That absorption is facilitated by any fluid, including perspiration.
The process is known as dermal absorption. Once a substance passes through the outer layers of skin, it passes into the lymph and local vascular (blood vessel) system and soon thereafter into the bloodstream. While the exact mechanisms of skin transfer are not completely understood, three routes of penetration have been hypothesized:
Intercellular Skin Absorption, which occurs between the cells of the “stratum corneum”, the outermost layer of the skin;
Transcellular Skin Absorption, where substances actually pass through the skin cells themselves; and
Skin Absorption Through the Follicles and Glands, also known as “appendageal absorption”, which may also exhibit “reservoir effects” in which substances may be stored within glands for absorption over time.
Skin Permeability: The Good and The Bad
Some of the most convincing stories of substances passing into the body via the skin come from governmental agencies actively studying and monitoring dermal absorption through their chemical safety divisions.
A 2005 report published by the World Health Organization takes a very clear position on skin permeability:
“While the skin does act as a barrier, it is not a complete barrier. Many chemicals do penetrate the skin, either intentionally or unintentionally, and cutaneous metabolism does occur. Because of its large surface area, the skin may be a major route of entry into the body . . . .”
This “major route of entry” has become a concern in many circumstances where toxic substances are released into air, water, and even city water supplies.
The California Environmental Protection Agency issued a report entitled “Chlorinated Chemicals in Your Home”, warning of the risks of cancer due to chlorinated chemicals. The agency issued the statement: “Taking a long, hot shower in a typical small shower stall can substantially increase your exposure to chloroform. If you use indoor spas, hot tubs, or swimming pools, you are also likely to be exposed to high levels of chloroform.”
Health Canada has estimated that skin exposure to certain toxic hydrocarbons in the Great Lakes may be as dangerous as oral exposure, issuing alerts to bathers, especially those affected by sunburn, which may enhance absorption.
Worker safety is an issue. Workers in various industries have suffered poisoning, in some cases fatal, from substances penetrating exclusively through the skin and into the bloodstream, such as through dermal exposure to leaded gasoline and insecticides.
The European Commission and the World Health Organization have both issued Guidance Documents, such as the “Guidance Document on Dermal Absorption” and International Programme on Chemical Safety Environmental Health Criteria serve to instruct agencies on how to protect workers from exposure to toxic compounds. The absorption of metals through the skin has been shown and considered to be occurring, as noted in the health Risk Assessment Guidance for Metals, Fact Sheet 01 published in August of 2007. The instant invention here provides for the contact with the skin and perspiration to provide exposure to the skin for transdermal absorption of the key metal micronutrients of Table 1. While such government agencies work to stop the transfer of chemicals through the skin, transdermal drug delivery products seek to take advantage of it. Transdermal patches are produced as delivery systems for nicotine, hormones, painkillers, and other substances.
These methods often provide clear advantages over oral medications, as outlined by Stanley Scheindlin, pharmaceutical chemist, in the journal Molecular Interventions:
“Patients often forget to take their medicine, and even the most faithfully compliant get tired of swallowing pills, especially if they must take several each day. Additionally, bypassing the gastrointestinal (GI) tract would obviate the GI irritation that frequently occurs and avoid partial first-pass inactivation by the liver.”
This instant invention looks at this dermal absorption effect to provide micronutrients from alloys containing the critical micronutrients of Iron, Zinc, Chromium, Manganese, Copper, Molybdenum, and Nickel, or any other metal micronutrients, that come in contact with the skin in the form of base metal, metal oxide or metal salts. The dermal absorption may occur with the alloys in contact with the skin. The alloys could incorporate all of the micronutrient metals such as Iron, Zinc, Chromium, Manganese, Copper, Molybdenum, and Nickel.
Depending on the alloy, a combination of the above metals would incorporate all, or any combination of, the metal micronutrients offered by the instant invention. Theoretical combinations of alloys with the constituent micronutrient metals contained therein could be almost infinite in number, but the alloys must be workable in a way that can be made into jewelry and other wearable items or accessories and at a reasonable cost to provide for a commercial product that can be commercially available for sale and use. That all being noted, the alloys will most likely be those that are principally of iron with the remaining constituents, Zinc, Chromium, Manganese, Copper, Molybdenum, and Nickel alloyed with the Iron. Table 2 below sets forth the range of constituents that could be expected for an Iron based alloy.
Table 3 below sets forth the range of constituents that could be expected for copper based alloys.
It is important that the alloy contain combinations of Iron, Zinc, Chromium, Manganese, Copper, Molybdenum, and Nickel. They can be in varying percentages for example, Iron could be 99.4% and each of the remaining micronutrients can be each 0.1%. This can hold for each micronutrient element. Zinc could be 99.4% and each of the remaining micronutrients can be 0.1%. Chromium could be 99.4 and each of the remaining micronutrients can be 0.1%. Manganese could be 99.4% and each of the remaining micronutrients can be 0.1%. Copper could be 99.4% and each of the remaining micronutrients can be 0.1%. Molybdenum could be 99.4% and each of the remaining micronutrients can be 0.1%. Nickel could be 99.4% and each of the remaining micronutrients can be 0.1%.
There are numerous combinations of acceptable percentages, as long as the alloy contains measurable amounts of Iron, Zinc, Chromium, Manganese, Copper, Molybdenum, and Nickel, and any other metal micronutrient deemed useful, but commercial viability supports the percentage ranges in the two Tables for the Iron based alloys and the Copper based alloys, which would be more readily used, and the invention herein provides for the creation of alloys that contain the key micronutrients noted. The examples in the preceding paragraph can be accomplished and are incorporated as alloys, even though they may not have been purely commercially chosen they could still be used for many other reasons, including aesthetic appearance.
The key aspect is to have the elemental metals of Iron, Zinc, Chromium, Manganese, Copper, Molybdenum, and Nickel as the micronutrient payload placed in contact with the skin. The payload can be in the form of the alloys above or they can take other forms, or be part of other compounds, as required to place the payload proximate to the user's skin.
All drawings are for the purpose of describing examples of versions of the present invention and are not intended to limit its scope. The present invention encompasses all products, and particularly jewelry products, designed to place a micronutrient payload in contact with the skin.
The present invention provides for jewelry configurations in which sections of the jewelry contain areas in which metal micronutrients are present as elemental metals, or the salts/oxides of such metals, in alloys that enable perspiration to become a transfer medium, thus permitting passage of the micronutrients into the skin. Such micronutrients comprise the “payload” of the jewelry item.
In one embodiment of the present invention, the payload can be provided as a metallic alloy that combines the selected micronutrients in a ratio defined by a combination of:
a. Ability of a particular metallic micronutrient, in elemental form or as a salt or oxide, to pass transcutaneously into tissues.
b. Probability of deficiencies in a typical user.
c. Generally accepted Minimum Daily Requirement (MDR) for each micronutrient.
d. Identified sensitivities by prospective user(s).
In this embodiment of the present invention, the micronutrient payload is provided as a permanent part of the jewelry item. In linked jewelry, links can each be made from one of the selected payload micronutrients. In jewelry consisting of a solid band, as in a bracelet, the metal can be a homogeneous combination or alloy, comprised of various combinations of the metal micronutrients selected for the payload. Stranded jewelry can be made from wires, each comprised of one or more of the selected micronutrient payload, twisted and bonded to form the visual impression of a cable.
In another embodiment, the payload is carried in an add-on accessory that can be fitted onto existing jewelry. Said accessory can be a band around the original jewelry piece, or can be of any other form factor that will be supported by the original jewelry piece and will permit contact between the payload and skin.
In a further embodiment, the payload is a removable addition to or part of jewelry that can be replaced when the payload is depleted. One method consistent with this embodiment uses a bracelet of common metal such as stainless steel 316L, with individual micronutrients or combinations of micronutrients expressed as one or more separate band(s) that clip(s) circumferentially around the long axis of that basic bracelet. This embodiment has the additional advantage of permitting the removal of a micronutrient band to which the wearer reacts adversely.
In another embodiment, a bracelet can be manufactured with holes along its long axis, with selected individual metal micronutrients available as rivets or screws that can be mounted through those holes, placing a flattened surface against the user's skin. This embodiment has the additional advantage of enabling selection of add-ons based upon the user's needs, with the possibility that a known deficiency of one micronutrient will be compensated by using multiple rivets or screws of that material.
In another embodiment, the payload can be plated upon a metal surface, with sufficient plating thickness to provide the desired effect for the desired lifetime. Besides plating, the payload can be deposited by means of vapor deposition, plasma or thermal spraying, or ion beam techniques. In an extension of this embodiment, the payload can be micronutrients added to inks that are then printed onto the surface to be placed against the skin.
In another embodiment, the payload can be plated or printed upon one side of a substrate made of metal foil, fabric, paper or plastic, with an adhesive on the other side, so the present invention can be adhered to the back of a watch, amulet, bracelet, or other jewelry item.
In all configurations and embodiments, the payload can be comprised of individual metal bands or sections, each of which is made of one discrete micronutrient metal, such as Iron, Zinc, Chromium, Manganese, Copper, Molybdenum, and Nickel.
In all configurations and embodiments, the payload can be comprised of one alloy or multiple alloys, each of which includes multiple selected metal micronutrients.
In all configurations and embodiments, the payload can be comprised of selected metal micronutrients delivered as chemical compounds, such as a salt or oxide of selected micronutrients.
In all configurations and embodiments, individual metal micronutrients can be built into or onto the device with an exposed area proportional to the human requirement for that element, with consideration of the ability of that micronutrient to transfer transcutaneously, Recommended or Minimum Daily Requirement (RDR, MDR), and user sensitivities to specific micronutrient materials.
In all configurations and embodiments, the payload can be comprised of selected metal micronutrients, subject to sensitivities or allergies of the wearer. For example, a device, garment, or personal accessory can be so constructed that the wearer can selectively attach buttons, pads, bands, patches, or links, each providing a desired micronutrient or combination of micronutrients, thereby permitting the deletion of any micronutrient to which the user reacts adversely.
The present invention is primarily a means by which micronutrients are made available for transcutaneous delivery, and can provide mineral or vitamin micronutrients suitable for delivery by the method of placing a payload of such materials on the skin of the user. All references herein to “micronutrients” shall include micronutrient metals, minerals, and vitamins, and compounds containing them, which the present invention places in contact with the skin to enable dermal absorption.
All wrist bands, neckbands, jewelry items, accessories for jewelry, and clothing items intended to bring sources of micronutrients into contact with the skin are within the scope of the present invention, whether said payloads are components of an alloy or as separate metals, are metals or minerals, or include vitamins or other non-metallic micronutrients
In one embodiment of the present invention, the payload can be provided by a patch to be adhered to the skin, in a manner similar to that used by nicotine and pain-suppression patches.
In one embodiment of the present invention, the payload can be provided in clothing items, such as a hat in which the band provides micronutrients to the skin of the wearer, and in socks where threads include a micronutrient payload. There can be a woven section of clothing containing the micronutrients for use as socks, stocking, arm band, wristband, headbands and hats.
In a still further embodiment, there can be a replaceable patch containing the payload that can be added to clothing, hats, gloves and footwear or can be supplied with the patch already adhering to these items. The patch can be removed and replaced once there is an indication on the patch that replacement is necessary. Such an indication could be a change of color to the patch or the appearance of a message indicating the need for replacement after the outer payload is worn away.
The objectives of the present invention can be met with fabric, in which the micronutrient payloads are expressed as threads that are woven into the overall material of which clothing is made.
All means by which micronutrients are placed in contact with the user's skin, thus creating an opportunity for transcutaneous transfer, are considered to be within the scope of the present invention.
The base metal of the bracelet can be any formable metal and added strips, rivets, wires, plating, and metal deposition can be utilized to provided the micronutrient metals needed or desired.
The clothing herein can be any kind of clothing from winter wear to summer wear, the key is to either have the replaceable adhering payload patch on the clothing in contact with the skin or clothing manufactured with the micronutrient metals in the material.
The jewelry herein can be any kind of jewelry including but not limited to bracelets, necklaces, earrings, tiaras, anklets, watches, hoops for the arm and wrist, and rings. Bracelets can include those worn around wrist, ankle, leg, knee, arms, head, and neck. These bracelets can be used for sports or for any other use or just worn as an adornment.
The payload can be a patch that is applied on watches, jewelry, hats, footwear, and clothing with the patch having an indicator telling a user to change the payload patch. The patch can be on the interior or a headband or a hat. It can be in shoes, socks, pants, and under garments, where the clothing is woven with sections of the micronutrients in the form of metal wires or threads.
The payload can be any micronutrient capable of being placed in contact with the skin in a manner consistent with the methods illustrated herein.
The present invention is not limited to the embodiments described here. The rights sought are rather defined by the following claims, within the scope of which many modifications can be envisaged.
Provisional Application Ser. No. 62/018,031, filed on Jun. 27, 2014.