SILICONE IMPLANT ADJUNCT FORMULATIONS AND METHODS OF USE

Abstract

A nutritional supplement product may be formulated to be used or digested by a person and to support the prevention of systemic health concerns that can arise after implanting exogenous silicone devices inside the human body. Such supplements may also promote the healthy production and balance of scar tissue, including a scar tissue capsule. Such supplement may be used as an adjunct therapy to a silicone device implantation procedure.

Claims

1. A method for promoting health while a silicone implant is in a human body, comprising: providing a nutritional supplement that is an adjunct therapy to a silicone implantation procedure that implants a silicone implant in a human body; and ingesting the nutritional supplement while the silicone implant is in the human body.

2. The method of claim 1, wherein the nutritional supplement comprises a base component and a collagen support blend, wherein the base component comprises an effective amount of Vitamin A, an effective amount of Vitamin C, an effective amount of Vitamin D, an effective amount of Vitamin E, an effective amount of Vitamin K2, an effective amount of Folate, an effective amount of Vitamin B12, an effective amount of Calcium, an effective amount of Zinc, and an effective amount of Selenium, and the collagen support blend comprises an effective amount of L-Lysine HCl, an effective amount of Bromelain, an effective amount of L-Proline, an effective amount of Quercetin, an effective amount of L-Carnosine, an effective amount of Centella asiatica Extract, an effective amount of Aloe vera Extract, an effective amount of Zinc Picolinate, and an effective amount of Lysine-Proline-Valine.

3. The method of claim 2, wherein the nutritional supplement further comprises an immune modulation blend comprising an effective amount of L-Glutamine, an effective amount of Mixed Tocopherols, an effective amount of Glycine, an effective amount of PQQ, and an effective amount of Cholecalciferol.

4. The method of claim 3, wherein the nutritional supplement further comprises a detox blend comprising an effective amount of Carrot Root Extract, an effective amount of L-Leucine, an effective amount of Molybdenum Glycinate, an effective amount of Fulvic Acid, an effective amount of 5-MTHF, an effective amount of Calcium, and an effective amount of Methylcobalamin.

5. The method of claim 4, wherein the nutritional supplement does not contain heavy metals.

6. The method of claim 5, further comprising: supporting the growth of scar tissue around the silicone implant.

7. The method of claim 5, wherein the nutritional supplement is ingested at least once a day while the silicone implant is in the human body.

8. The method of claim 6, further comprising: dampening at least one of MMP pathways of the human body.

9. The method of claim 8, wherein the MMP pathway is dampened by decreased production of MMP-9.

10. A method for promoting health while a silicone implant is in a human body, comprising: providing a nutritional supplement that is an adjunct to a silicone implantation procedure that places a silicone implant in a human body, wherein the nutritional supplement consists essentially of about 300 mg of Quercetin, about 200 mg of Carnosine, about 200 mg of Centella asiatica extract, about 200 mg of Aloe vera extract, about 3 mg of Zinc, about 300 mg of Bromelain, about 300 mg of Lysine, about 300 mg of Proline, and about 300 mg of KVP as Lys-Pro-Val; and ingesting the nutritional supplement.

11. The method of claim 10, wherein the nutritional supplement further comprises about 750 mg of Ascorbic Acid, about 750 mg of Glutamine (L), about 0.1 mg of Mixed Tocopherols, about 100 mg of Glycine, about 0.1 mg of Vitamin K2 as menaquinone 7, about 0.025 iu of Selenomethionine, about 2.0 mg of PQQ, about 2000 iu of Cholecalciferol, and about 100 iu of Retinyl Palmitate.

12. The method of claim 11, wherein the nutritional supplement further comprises about 350 mg of Carrot Root, about 100 iu of Retinyl Palmitate, about 350 mg of Calcium d-glucarate, about 150 mg of Leucine, about 300 mg of Molybdenum chelate, about 0.3 mg of Methylfolate, and about 0.15 mg of Methylcobalamin.

13. The method of claim 12, wherein the nutritional supplement does not contain heavy metals.

14. A method for promoting health while a silicone implant is in a human body, comprising: providing a nutritional supplement that is an adjunct to a silicone implantation procedure, wherein the nutritional supplement comprises about 21 mcg RAE of Vitamin A, about 335 mg of Vitamin C, about 17.5 mcg of Vitamin D, about 67 mg of Vitamin E, about 70 mcg of Vitamin K2, about 200 mcg DFE of Folate, about 100 mcg of Vitamin B12, about 6 mg of Calcium, about 700 mcg of Zinc, and about 17 mcg of Selenium; and ingesting the nutritional supplement at least once a day.

15. The method of claim 14, wherein the nutritional supplement further comprises a collagen support blend, an immune modulation blend, and a detox blend.

16. The method of claim 15, wherein the nutritional supplement does not contain heavy metals.

17. The method of claim 15, wherein the collagen support blend comprises about 300 mg of Quercetin, about 200 mg of Carnosine, about 200 mg of Centella asiatica extract, about 200 mg of Aloe vera extract, about 3 mg of Zinc, about 300 mg of Bromelain, about 300 mg of Lysine, about 300 mg of Proline, and about 300 mg of KVP as Lys-Pro-Val.

18. The method of claim 15, wherein the immune modulation blend comprises about 750 mg of Ascorbic Acid, about 750 mg of Glutamine (L), about 0.1 mg of Mixed Tocopherols, about 100 mg of Glycine, about 0.1 mg of Vitamin K2 as menaquinone 7, about 0.025 iu of Selenomethionine, about 2.0 mg of PQQ, about 2000 iu of Cholecalciferol, about 100 iu of Retinyl Palmitate, and about 300 mcg of KVP as Lys-Pro-Val.

19. The method of claim 15, wherein the detox blend comprises about 350 mg of Carrot Root, about 200 iu of Retinyl Palmitate, about 350 mg of Calcium d-glucarate, about 150 mg of Leucine, about 300 mg of Molybdenum chelate, about 0.3 mg of Methylfolate, and about 0.15 mg of Methylcobalamin.

20. The method of claim 15, further comprising: supporting the growth of scar tissue around the silicone implant.

Description

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0027] It will be readily understood that the components of the present invention, as generally described herein, could be arranged and designed in a wide variety of different configurations or formulations. Thus, the following more detailed description of the embodiments of the system, product and method of the present invention is not intended to limit the scope of the invention, as claimed, but is merely representative of various embodiments of the invention.

[0028] A nutritional supplement in accordance with the present invention may be comprised of multiple components, for example and not by way of limitation, nutrients, natural peptides, synthetic peptides, investigational peptides, vitamins, minerals, plant extracts, and the like. A nutritional supplement may include one or more of these components depending on the intended use. Thus, a nutritional supplement may include some but not all of the components, and may still be suitable for its intended purpose, i.e., an adjunct supportive therapy, or the like.

[0029] In one embodiment, the method of preparation, formulation, or chemical synthesis of healthy scar tissue is accomplished by using reactants and/or nutrients that include at least the following: ascorbic acid, glutamine (L), mixed tocopherols, glycine, vitamin K2 (as menaquinone 7, Mk7), selenomethionine, Pyrroloquinoline quinone, cholecalciferol, retinyl palmitate, and KVP as Lys-Pro-Val. Each of the components/reactants has a respective function, but together may have a separate function.

[0030] In one embodiment, a nutritional supplement may include a base composition, which base composition may be comprised of the following: 21 mcg RAE of Vitamin A (Retinyl Palmitate); 335 mg of Vitamin C (Ascorbic Acid-Non Corn); 17.5 mcg of Vitamin D (Cholecalciferol); 67 mg of Vitamin E (Mixed Tocopherols); 70 mcg of Vitamin K2 MK7; 200 mcg DFE of Folate (5-MTHF); 100 mcg Vitamin B12 (Methylcobalamin); 6 mg of Calcium (D-Glucarate); 700 mcg of Zinc (Picolinate); and 17 mcg of Selenium (L-Selenomethionine).

[0031] In the same embodiment, or another embodiment, 900 mg of an immune modulation blend may be included, which immune modulation blend may be comprised of the following: Ascorbic Acid, L-Glutamine, Mixed Tocopherols, Glycine, Vitamin K2 MK7, L-Selenomethionine, PQQ (pyrroloquinoline quinone), Cholecalciferol, and Retinyl Palmitate.

[0032] In the same embodiment, or another embodiment, 360 mg of a collagen response blend may be included, which collagen response blend may be comprised of the following: L-Lysine, HCl, Bromelain, L-Proline, Quercetin, L-Carnosine, Centella asiatica Extract, Aloe vera Extract, Zinc Picolinate, and Lysine/Proline/Valine.

[0033] In the same embodiment, or another embodiment, 210 mg of a gentle detox support blend may be included, which gentle detox support blend may be comprised of the following: Carrot Root Extract, Calcium D-Glucarate, L-Leucine, Molybdenum Glycinate, Fulvic Acid, 5-MTHF, Calcium, and Methylcobalamin.

[0034] In the same embodiment, or another embodiment, other ingredients may include cellulose and vegetable stearate. The base composition, immune modulation blend, collagen response blend, and gentle detox support blend may be described as one serving of a nutritional supplement in accordance with the invention. The amounts of the respective formulation components may vary within a range of approximately ±10% by weight.

[0035] In one embodiment, a capsule for a nutritional supplement may be comprised of purple carrots, which creates a plant-based capsule that provides a source of beta-carotene.

[0036] A nutritional supplement in accordance with the present invention should be taken as directed by a health care professional. It may be helpful to increase the amount of liquids a person drinks each day while taking the nutritional supplement.

[0037] In one embodiment, an immune modulation blend may be comprised of the following: 500-1000 mg of Ascorbic Acid; 500-100 mg of Glutamine (L); 0.1 mg of Mixed Tocopherols; 100 mg of Glycine; 0.1 mg of Vitamin K2, Mk7; 0.025 iu of Selenomethionine; 2.0 mg of PQQ; 1000-3000 iu of Cholecalciferol; 100 iu of Retinol Palmitate; and 50-500 mcg of KVP as Lys-Pro-Val.

[0038] An immune modulation blend, or any similarly formulated immune support supplement, provides the human body with nutrients that have been clinically researched to be missing in patients with an autoimmune disease process in the presence of exogenous foreign devices, i.e., silicone implants. Such a supplement utilizes key nutrients to support those with predisposition to the development of these processes in relationship to decreasing gut inflammation, provide substrates that promote and recycle glutathione, and foster immune modulation. The amounts of the respective formulation components may vary within a range of approximately ±10% by weight.

[0039] In one embodiment, a collagen response blend, or scar tissue response blend, may comprise the following: 100-500 mg of Lysine HCL; 100-500 mg of Bromelain; 100-500 mg of Proline; 100-500 mg of Quercetin; 50-300 mg of Carnosine; 46-500 mg of Centella Asiatica Extract; 46-500 mg of Aloe Vera Extract; 50-500 mcg of KVP as Lys-Pro-Val; and 1-5 mg of Zinc Picolinate.

[0040] A collagen response blend, or any similarly formulated collagen support supplement, supports the formation of a healthy collagen response of scar tissue capsule around an implant to ensure there is not too little scar tissue, primarily by accounting for the connection between various types of hypermobility, both generic and acquired, which may cause a maladaptive collagen response. Medically stated, a collagen response blend aims to improve collagen response in humans with silicone implants by supporting the MMP pathways. MMP pathways are a class of enzymes that belong to the zinc-metalloproteinases involved in the degradation of the extracellular matrix. A collagen response blend may primarily focus on MMP-9 and its role in histamine regulation and its relationship to skin laxity. A collagen response blend, especially including an effective amount of KVP as Lys-Pro-Val, may support the formation of a healthy scar tissue response in the presence of silicone implants such that the development of keloid or hyperactive scar tissue is avoided. Additionally, a collagen response blend, especially including an effective amount of KVP as Lys-Pro-Val, may improve wound healing in post-surgical wounds and/or scars. The amounts of the respective formulation components may vary within a range of approximately ±10% by weight.

[0041] In one embodiment, a gentle detox support blend, or detoxification support blend, may comprise the following: 200-500 mg of Carrot root; 100-300 iu of Retinyl Palmitate; 100-500 mg Calcium d-glucarate; 26-300 mg of Leucine; 300 mg of Molybdenum chelate; 0.3 mg of Methylfolate; and 0.15 mg of Methylcobalamin.

[0042] A gentle detox blend, or any similarly formulated detox support supplement, may support vital pathways in the body responsible for detoxification in the presence of exogenous silicone implants with the primary goal of reducing reabsorption of exogenous estrogen-like compounds, or “xenoestrogens,” and correcting for genetic mutations in common methylation enzymes such as Methylene tetrahydrofolate reductase (MTHFR) and variants to support the body's detoxification process phase 1 and 2 as an adjunct to implantation with silicone devices. Additionally, preliminary studies also show the combination of retinoids and glucarate to be preventative in development of breast cancer, based on the relationship between implants and BIALCL (breast implant associated large cell lymphoma). The amounts of the respective formulation components may vary within a range of approximately ±10% by weight.

[0043] It may be noted that two components or nutrients, Vitamin A and KVP as Lys-Pro-Val (synthetic peptide), are repeated in various blends. This indicates the multi-faceted purposes of these components. In a single-formulation embodiment, this does not mean that the amount of these components should be doubled or tripled, but the stated quantity in each listing may reflect the quantity listed in a single-formulation embodiment.

[0044] A person undergoing a silicone implantation procedure may expect various, possible issues associated with having a silicone implant in their body. A nutritional supplement in accordance with the present invention may be designed or formulated to address one or more of such issues. For example and not by way of limitation, a person may experience issues related to the development of collagen, possible autoimmune reactions, and the presence of toxins.

[0045] Chronic toxins, i.e., chemicals and heavy metals, allergens, and pathogens that affect a person or patient prior to implantation of a silicone implant may drive upregulation of the MMP-9 pathway of the immune system, which may be described as one form of an “allergic response.” MMP-9 causes mast cell activation. Mast cell activation and priming drives excess histamine production. Excess histamine production degrades the collagen matrix in the body, specifically type IV collagen (Co14), but potentially others. Dysregulation of systemic collagen in the body by excess histamine in the body hinders the patient's ability to build a protective, productive capsule of collagen around their silicone implant after implantation. Dampening the degradation of collagen protects the patient's body from too thin a capsule tissue or too thick a capsule caused by maladaptive response, which leaves it vulnerable to the immune system's macrophages, which mobilize micro silicone and its chemical formula companions by phagocytosis for example.

[0046] In one embodiment, particularly an embodiment of a collagen response blend, a nutritional supplement may comprise effective amounts of quercitin, carnosine, Centella asiatica, Aloe vera, zinc, bromelain, lysine, proline and KVP as Lys-Pro-Val. This combination of nutrients is used to dampen the MMP-9 pathway, thereby reducing excess histamine and promoting the formation of healthy collagen, including collagen adjacent to and around a silicone implant device.

[0047] In the presence of new, foreign devices, and especially mobilized micro silicone, a patient may develop an autoimmune reaction. Such a reaction has been documented in silicone research.

[0048] In one embodiment, particularly an embodiment of an immune modulation blend, a nutritional supplement may comprise effective amounts of Vitamin C, glutamine, Vitamin E, Vitamin K, glysine, selenium, Vitamin D, Vitamin A, and PQQ.

[0049] The introduction of a silicone implant into the human body may also result in the introduction of certain toxins into the body. For example, xenoestrogens and other chemicals found in silicone devices, and in the environment, may hinder the health of a person with a silicone implant device.

[0050] In one embodiment, particularly an embodiment of a detox support blend, a nutritional supplement may comprise effective amounts of Vitamin A, calcium d-glucarate, leucine, molybdenum, methylfolate, methylcobalamin, and fulvic acid.

[0051] It is important that any nutritional supplement embodiment in accordance with the present invention not contain heavy metals, nor microbial contamination. One of the problems with implant rupture, and/or implant sweating, is the introduction of heavy metals into the body. A nutritional supplement in accordance with the present invention should not contribute to this problem.

[0052] In one embodiment, a method for promoting the health of a person while a silicone implant is inside the person's body may comprise the following steps: providing a nutritional supplement that is an adjunct therapy to a silicone implantation procedure, which procedure places, or implants, a silicone implant, or silicone implant device, in a human body; and ingesting the nutritional supplement. The nutritional supplement used as an adjunct therapy may comprise, or consist essentially of, or consist of, the following nutrients: about 300 mg of Quercetin, about 200 mg of Carnosine, about 200 mg of Centella asiatica extract, about 200 mg of Aloe vera extract, about 3 mg of Zinc, about 300 mg of Bromelain, about 300 mg of Lysine about 300 mg of Proline, and about 300 mg of KVP as Lysine-Proline-Valine.

[0053] The nutritional supplement used as an adjunct therapy may further comprise, or further consist essentially of, or further consist of, the following nutrients: about 750 mg of Ascorbic Acid, about 750 mg of Glutamine (L), about 0.1 mg of Mixed Tocopherols, about 100 mg of Glycine, about 0.1 mg of Vitamin K2 as menaquinone 7, about 0.025 iu of Selenomethionine (L-selenomethionine), about 2.0 mg of PPQ, about 2000 iu of Cholecalciferol, and about 100 iu of Retinyl Palmitate.

[0054] The nutritional supplement used as an adjunct therapy may further comprise, or further consist essentially of, or further consist of, the following nutrients: about 350 mg of Carrot Root Extract, about 100 iu of Retinyl Palmitate, about 350 mg of Calcium d-glucarate, about 150 mg of Leucine, about 300 mg of Molybdenum chelate, about 0.3 mg of Methylfolate, and about 0.15 mg of Methylcobalamin.

[0055] In one embodiment, a method for promoting the health of a person while a silicone implant, or silicone device, is inside a human body of the person may comprise the following steps: providing a nutritional supplement that may comprise about 21 mcg RAE of Vitamin A, about 335 mg of Vitamin C, about 17.5 mcg of Vitamin D, about 67 mg of Vitamin E, about 70 mcg of Vitamin K2, about 200 mcg DFE of Folate, about 100 mcg of Vitamin B12, about 6 mg of Calcium, about 700 mcg of Zinc, and about 17 mcg of Selenium; and ingesting the nutritional supplement at least once a day, or in accordance with a doctor's recommendation.

[0056] The nutritional supplement may further comprise a collagen support blend, an immune modulation blend, and/or a detox blend. The nutritional supplement should not contain or include heavy metals that are adverse to the intended use of the nutritional supplement. The nutritional supplement may be used to promote and/or support the healthy production of scar tissue, which scar tissue may form near, adjacent to, and/or around a silicone implant, or silicone implant device.

[0057] The collagen support blend may further comprise, or may further consist essentially of, or may further consist of, the following components: about 300 mg of Quercetin, about 200 mg of Carnosine, about 200 mg of Centella asiatica extract, about 200 mg of Aloe vera extract, about 3 mg of Zinc, about 300 mg of Bromelain, about 300 mg of Lysine, about 300 mg of Proline, and about 300 mg of KVP as Lys-Pro-Val.

[0058] The immune modulation blend may further comprise, or may further consist essentially of, or may further consist of, the following components: about 750 mg of Ascorbic Acid, about 750 mg of Glutamine (L), about 0.1 mg of Mixed Tocopherols, about 100 mg of Glycine, about 0.1 mg of Vitamin K2 as menaquinone 7, about 0.025 iu of Selenomethionine, about 2.0 mg of PQQ, about 2000 iu of Cholecalciferol, about 100 iu of Retinyl Palmitate, and about 300 mcg of KVP as Lys-Pro-Val.

[0059] The detox blend may further comprise, or may further consist essentially of, or may further consist of, the following components: about 350 mg of Carrot Root Extract, about 200 iu of Retinyl Palmitate, about 350 mg of Calcium d-glucarate, about 150 mg of Leucine, about 300 mg of Molybdenum chelate, about 0.3 mg of Methylfolate, and about 0.15 mg of Methylcobalamin.

[0060] The present invention may be embodied in other specific forms without departing from its fundamental functions or essential characteristics. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. All changes which come within the meaning and range of equivalency of the illustrative embodiments are to be embraced within their scope.