WO2023275761A1 - Composition and method for enhancing tattoo vibrancy - Google Patents
Composition and method for enhancing tattoo vibrancy Download PDFInfo
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- WO2023275761A1 WO2023275761A1 PCT/IB2022/056019 IB2022056019W WO2023275761A1 WO 2023275761 A1 WO2023275761 A1 WO 2023275761A1 IB 2022056019 W IB2022056019 W IB 2022056019W WO 2023275761 A1 WO2023275761 A1 WO 2023275761A1
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- tattoo
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/48—Reproductive organs
- A61K35/50—Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/40—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing ingredients of undetermined constitution or reaction products thereof, e.g. plant or animal extracts
Definitions
- Tattooing is a well-known and widespread practice of marking or decorating skin. It is accomplished by injection of ink into small holes in the skin, more specifically into the upper layer of the dermis. To do so, typically pricking needles that penetrate the natural (epidermal) skin barrier are used.
- Tattoo ink is a suspension of pigment particles in a liquid carrier, which is usually a solution of water, glycerin and alcohol.
- the colorant in tattoo ink is derived from organic and inorganic pigments that cover a wide range of colors.
- the liquid carrier may also contain additives such as binders, surfactants, preservatives, and thickening agents. A fraction of the injected colorant stays in the dermis as particles. The light absorption of these particles within a specific spectral range results in the colors of the tattoo.
- part of the colorant may leave the skin with the bleeding during or directly after tattooing.
- part of the colorant may be transported away from the skin via the lymphatic or blood vessel system.
- part of the colorant is decomposed months or years after tattooing because the pigments in the dermis are repeatedly exposed to different light sources, in particular, solar radiation, including UV radiation.
- One aspect of the invention is a method for preserving the visual aesthetics of a tattoo, such as color, clarity and/or contrast sharpness, in a tattoo.
- the method comprises topically administering to the tattoo area a composition comprising amniotic fluid composition.
- the method can be used for maintaining the vibrancy of tattoos in both human and non-human subjects. Further, the method can be applied to a variety of tattoo areas, including decorative tattoos, tattoos applied as permanent make-up, and tattoos used to camouflage scars.
- a composition comprising amniotic fluid is topically applied to a tattoo area to enhance tattoo stability.
- FIG. 1 is a cross-section illustration of human skin anatomy by Sheeler et al. (Sheeler, P. and Bianchi, D.E. Cell Biology - Structure, Biochemistry, and Function, 2nd Edition.
- a tattoo pattern may comprise thick lines, thin lines, and color areas.
- Numerous types of machines used for tattoo lines, color or shading have been developed over the years including dual coiled machines, single-coil machines, rotary machines and hybrid machines.
- Conventional tattoo machines comprise a reciprocating needle that moves up and down, and m many cases, within a tubular or cylindrical structure that carries ink into the skin of an individual during the process of having a tattoo drawn on the individual's skin.
- the reciprocating needle typically punctures the skin at a high rate of frequency. Tatoo machine needles are installed in the machine and dipped in ink, which is sucked into the machine's tube system.
- adult human skin is a layered organ consisting of an epidermis and a dermis.
- the epidermis is the most superficial layer of the skin and is classified into several layers.
- the dermis is composed of two layers, the papillary and reticular layers.
- the skin also contains hair follicles, glands, and nerve endings responsible for the sense of touch and pain.
- the hypodermis which is sometimes considered a layer of skin, lies beneath the dermis and is composed mainly of adipose tissue. (Kawasumi et al, Wound Healing in Mammals and Amphibians: Toward Limb Regeneration in Mammals. Current Topics in Microbiology and immunology, December 2.012, DOT: 10.1007/82 2012 305).
- the amniotie fluid composition is applied to the tattoo area during the tattoo procedure and/or after completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area during the tattoo procedure and after the completion of the tatoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area during the tattoo procedure or after the completion of the tatoo procedure. In one embodiment of the invention, the amniotie fluid composition is not applied to the tattoo area during the tatoo procedure. In one embodiment of the invention, die amniotie fluid composition is not applied to the tattoo area after the completion of the tattoo procedure.
- the amniotie fluid composition is applied to the tattoo area approximately at the mid-point of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area approximately at the mid-point of the tattoo procedure and after tine completion of the tattoo procedure. In one embodiment of die invention, the amniotie fluid composition is applied to the tattoo area at the mid-point of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area at the mid-point of the tattoo procedure and after the completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area before the end of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area before the end of the tattoo procedure and after the completion of the tattoo procedure,
- the amniotie fluid composition is applied to the tattoo area within 5 hours after completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area within 4 hours after the completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area within 3 hours after the completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area within 2 hours after the completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area within 1 hour after the completion of the tattoo procedure.
- the amniotic fluid composition is applied to the tattoo area within 30 minutes after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 20 minutes after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition 1s applied to the tattoo area within 10 minutes after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 5 minutes after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 4 minutes after the completion of the tattoo procednre. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 3 minutes after the completion of the tattoo procedure.
- the amniotic fluid composition is applied to the tattoo area within 2 minutes after the completion of the tattoo procedure, in one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 1 mi mite after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area immediately after completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area during any stage of the healing process following the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area during any stage of the healing process of the wounds resul ting from the tattoo procedure.
- the amniotic fluid composition is applied to the tattoo area before the completion of the healing process. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area before the completion of the healing process of the wounds induced by the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition enhances the healing of the tattoo area.
- the amniotic fluid composi tion is applied to the tattoo area.
- the amniotic fluid composition is directly applied the tattoo area.
- the amniotic ⁇ fluid composition is indirectly applied the tattoo area.
- the amniotic fluid composition is applied more than once to the tattoo area.
- the amniotic fluid composition is applied at least once to the tattoo area, in one embodiment of the invention, the amniotic fluid composition is applied at least twice to the tattoo area.
- the means by which the amniotic fluid composition is applied to the tattoo area is not particularly ' limited. It can be applied, for example, by rubbing it into the tattoo area with a gloved hand.
- the amniotic fluid composition can also be applied with specific applicators such as a dropper or a spray or any other form of applicator.
- the location of the tattoo in the inventive method is not particularly limited.
- the tattoo can be located in an exposed area, such as on the neck, collarbone, shoulders, chest, ribcage, abdomen, upper arm, forearm, wrist, edge or top of hand, finger, upper back, lower back, upper thigh, ankle, foot, earlobe, behind the ear, hairline, perns, vagina, breasts, anus, male and female genitalia, or the like.
- the amniotic fluid composition can be applied to a tattoo of any color or mixture of colors.
- the most common color of a decorati ve tattoo is black, and followed by blue, green, red, yellow, and orange. All of these colors have different wavelength absorption, ranging from about 420 run to about 800 nm.
- the pigment particles used to create color in tattoo ink include both inorganic and organic compounds.
- Organic pigments are the main components of colored tattoo ink and include, for example, alizarin (crimson), azo pigments (yellow, orange and red), phthalocyanine (bine and green) and quinacridone (red-violet). Carbon (soot or ash) is used for black pigment.
- Commonly used inorganic pigments include titanium dioxide (white) and iron oxides (red, brown, and dark colors), in addition, fluorescent ink is used not only in decorative tattoos, but also for tattoos used in medical procedures conducted under dim light, and for animal tattoos to facilitate ease of identification at night or in laboratories.
- the tattoo is applied with ink comprising an organic pigment, an inorganic pigment, or mixtures thereof.
- the tattoo is applied to as a decorative marking.
- the tattoo is applied to a human subject as a decorative marking.
- Pigment particles in tattoos range in size from about 1 nm to about 1 ⁇ m. Colored and black pigments are particularly rich in nanomaterials (1 nm to 100 nm) whereas white pigments mainly contain particles larger than 100 nm.
- the amniotic fluid composition is applied to tattoos used as permanent makeup.
- Permanent makeup is facial tattooing in which colorants are placed in the skin to mimic normal make-up.
- Permanent makeup tattoos are increasingly popular and include, for example, eyebrow tattoos (i.e., microblading), lip tattoos (i.e., lip blushing), as well as eyeline and lash line tattoos.
- the amniotic fluid composition is applied to a tattoo used to mask a scar.
- the amniotic fluid composition is applied to a tattoo used to camouflage a scar.
- Flesh-colored tattoos cars be used to mask a scar or to reconstruct the nipple-areola complex after mastectomy.
- the tattoo area is covered with a clean, dry bandage to support the tissue, protect the wound from external trauma and contamination, and promote healing.
- the bandage used to cover the tattoo area includes any medical grade bandage useful for minor skin wounds, such as sterile gauze, TegadermTM Transparent Dressing, or Saniderm ® Tattoo Aftercare Bandage.
- the bandage must be large enough to cover the entire tattoo area as well as an inch or more of the surrounding skin.
- the bandage is LamellaRap ® .
- a bandage impregnated with amniotic fluid is directly applied to the tattoo area immediately after the needling procedure.
- the tattoo process creates a controlled injury to the dermis layer of the skin through the needling process.
- the amniotic fluid aids in repair and regeneration of skin tissues along with providing increased binding sites for ink to permanently remain fixed within the dermis.
- the amniotic fluid composition is rich in protein-based growth factors, many of which are bound onto cell membranes and within the extracellular matrix connective tissues after wound repair processes have restored cell and tissue integrity. Once the ink pigment particles are tightly bound to cell membranes and connective tissues, macrophages cannot engulf or remove the particles.
- the amniotic fluid composition comprises human amniotic fluid in any acceptable vehicle or carrier for topical use.
- vehicles for topical administration include, but are not limited to, solutions, lotions, emulsions, gels, wipes, sticks, sprays, oils, creams, and the like.
- the amniotic fluid composition is a solution.
- the amniotic fluid composition further comprises additives used in skin care products, including but not limited to moisturizers, antioxidants, vitamins, emollients, antimicrobial preservatives, anesthetic agents, anti-inflammatory agents, and brightening agents. Incorporation of additives into the human amniotic fluid composition may be desirable, for example, is the subject getting tattooed has dry or sensitive skin.
- the amniotic fluid composition comprises one or more additives selected from the group consisting of antioxidants, vitamins, emollients, lubricants, antimicrobial preservatives, anesthetic agents, anti-inflammatory agent, and brightening agents.
- the amniotic fluid composition comprises sterile purified human amniotic fluid. In an embodiment, the amniotic fluid composition consists essentially of sterile purified human amniotic fluid. In an embodiment, the amniotic fluid composition consists of sterile purified human amniotic fluid. In one embodiment of the invention, the amniotic fluid composition does not comprise any cell.
- the amniotic fluid composition is applied to preserve the visible esthetics of a tattoo.
- the visible esthetics of a tattoo are the color, clarity and contrast sharpness of the tattoo.
- the visible esthetics of a tattoo are the color, clarity or contrast sharpness of the tattoo.
- the amniotic fluid composition is AmnioTechTM (Instinktive, LLC; Salt Lake City, UT), a sterile, purified natural product free from preservatives.
- Other commercially available products derived from human amniotic fluid (HAF) include, but are not limited to PalinGen ® (BioPro; Port Huron, MI), FloGraft ® (Applied Biologies; Scottsdale, AZ), Genesis Amniotic Fluid (Genesis Biologies; Irvine, CA), AmnionTM (Arthrex, Inc.; Naples, FL), and ZofinTM (Organicell Regenerative Medicine, Inc. (Miami, FL).
- Amniotic fluid composition from human amniotic fluid contains naturally produced growth factors and active biologic agents such as cytokines, electrolytes, enzymes, nucleic enzymes, hormones, hyaluronic acid, lipids, and proteins. It comprises for example, hyaluronan, platelet-derived growth factor bb (PDGF-bb), bone morphogenetic protein 2 (BMP-2), transforming growth factor b ⁇ (TGF-bI), interleukin 8 (IL-8), and vascular endothelial growth factor (VEGF).
- cytokines cytokines
- electrolytes enzymes
- enzymes nucleic enzymes
- hormones hormones
- hyaluronic acid lipids, and proteins. It comprises for example, hyaluronan, platelet-derived growth factor bb (PDGF-bb), bone morphogenetic protein 2 (BMP-2), transforming growth factor b ⁇ (TGF-bI), interleukin 8 (IL-8), and vascular end
- the amniotic fluid composition can also be derived by aseptic processing of human amniotic fluid obtained during a Cesarian Section surgical procedure.
- the amniotic fluid is human amniotic fluid.
- the amniotic fluid is sterile.
- the amniotic fluid is fdtered.
- the amniotic fluid is sterile and filtered.
- the amniotic fluid composition is applied to the tattoo on a human subject.
- the human subject may be a male or female.
- the amniotic fluid composition can also be applied to the tattoo of an animal marked for identification. Cattle, horses, dogs, rats, turkeys, chinchillas, rabbits, foxes, fish, monkeys, and alligators are but a few of the animals that are marked with tattoos for identification purposes.
- the amniotic fluid composition is applied to the tattoo on a domesticated animal such as a tattoo on livestock (e.g., cattle, sheep, goats, horses, pigs, etc) or pet animals (e.g, dogs or cats).
- livestock e.g., cattle, sheep, goats, horses, pigs, etc
- pet animals e.g, dogs or cats
- the amniotic fluid composition is applied to the tattoo on a wild animal (e.g., laboratory animals; zoo animals; and wildlife).
- the tattoo is typically applied in green ink to a lightly pigmented and relatively hairless site or to a tattoo site that has been shaved.
- a clinical assessment can be performed after application of the amniotic fluid composition to the tattoo area using a modified Fitzpatrick skin type and Kirby-Desai scale scoring system.
- the Kirby-Desai scale was developed originally to assess tattoo-removal treatments.
- numerical values are assigned to six parameters: Fitzpatrick skin type, location, color, amount of ink, scarring or tissue change, and layering. Parameter scores are then added to yield a combined score that will show the estimated number of treatments needed for successful tattoo removal. (Kirby et al, The Kirby-Desai Scale: A Proposed Scale to Assess Tattoo-removal Treatments. J Clin Aesthetic Dermatol. 2009, 2(3):32-37).
- an optical imager may include a digital camera to take a picture that a computer can process to determine the color or colors in the tattoo.
- the optical imager may include a spectrophotometer that can measure absorbance of light of the tattoo to determine what the color of the tattoo is at a given point in time. (See, Peppou et al, US 2007/0055499).
- amniotic fluid growth factors contain binding agents such as cadherins that increase surface adhesion onto dermal cells and tissues (Maitre & Heisenberg, 2013). These binding agents tend to have an affinity to proteins and fibrous tissues such as those found in collagen and fibronectin. Once the ink particles are bound tightly to cell membranes and connective tissue matrices, macrophages cannot engulf nor remove the ink. Commonly found natural binding agents within the dermis are fibroblasts. A related family group of fibroblast cell growth factors (FGF-4, 6, 7, 9, 21) are included in amniotic fluid to augment those naturally found in the dermis. Ink pigment particles have been shown to bind to the surfaces of fibroblast cells.
- binding agents such as cadherins that increase surface adhesion onto dermal cells and tissues (Maitre & Heisenberg, 2013). These binding agents tend to have an affinity to proteins and fibrous tissues such as those found in collagen and fibronectin. Once the ink particles are bound tightly to cell membranes and connective tissue
- Fibroblasts are the most common cells of connective tissues, and they are mobilized in wound repair to synthesize collagen.
- the amniotic fluid composition mitigates the immune system.
- the amniotic fluid composition reduces the inflammatory response induced by the tattoo procedure.
- the amniotic fluid composition comprises one or more binding agents that bind to the ink particles, thereby reducing the immune response induced by the tattoo procedure.
- the amniotic fluid composition comprises one or more binding agents that bind to the ink particles, thereby reducing the inflammatory response induced by the tattoo procedure.
- the amniotic fluid composition reduces weeping of the tattoo area.
- the amniotic fluid composition maintains the integrity of the newly applied ink. In one embodiment of the invention, the amniotic fluid composition allows for shorter recovery time of the tattoo area than with a conventional tattoo procedure. In one embodiment of the invention, the amniotic fluid composition allows for reduced aftercare of the tattoo area than with a conventional tattoo procedure.
- composition comprising amniotic fluid is topically applied to a tattoo area to enhance tattoo stability.
- tannintoo may include a pattern in skin produced by injecting ink and/or other ink elements into the skin.
- Each ink element may include any of a variety of substances that may be applied at or into an injection site on skin of an animal.
- the area of the skin at which the tattoo is formed may be referred to as “the tattoo area” or “injection site”.
- the layer or depth of the skin to which each ink element is injected may include epidermis, dermis, or subcutis of the skin, substructures of the epidermis such as stratum lucidum, stratum granulosum, stratum spinosum, stratum mucosum, stratum germinativum, stratum comeum, or other substructure of the epidermis, particular regions of the dermis such as a papillary region, reticular region, or other region of the dermis, or other particular layers, substructures, or regions of the skin.
- substructures of the epidermis such as stratum lucidum, stratum granulosum, stratum spinosum, stratum mucosum, stratum germinativum, stratum comeum, or other substructure of the epidermis, particular regions of the dermis such as a papillary region, reticular region, or other region of the dermis, or other particular layers, substructures, or regions of the skin.
- the term “subject”' as used herein includes humans and non-human animals.
- the non-human is a pel animal, a livestock animal, a laboratory animal, a zoo animal, or a wild animal.
- the term "about” means a range of values including the specified value, which a person of ordinary skill in the art would consider reasonably similar to the specified value. In embodiments, about means within a standard deviation using measurements generally acceptable in the art. in embodiments, about means a range extending to +/- 10% of the specified value, in embodiments, about includes the specified value.
- Example 1 General Method for Amniotic Fluid Collection and Storage [053] A general method for the collection and storage of up to 500 cubic centimeter (cc) human amniotic fluid during a cesarean section surgical procedure is described. It does not cover shipping, testing or analysis of these specimens. All health care providers and technicians are expected to be trained and follow universal precautions when handling biological or hazardous materials.
- cc cubic centimeter
- Materials on site include the following: (1) 18-gauge IV angiocatli; (2) variable pipette (1 cc accuracy).
- Step 1 Before initiating procedures make sure collection supplies, labels and forms are in the room, ready and within easy reach.
- Step 2 After reflecting the bladder flap of the expandable drainage collection vessel, manually elevate fetal presenting part.
- Step 3 Insert IV angiocath through lower uterine segment avoiding placenta, withdraw' the sharp leaving only the soft plastic tubing in the uterus for passive-siphon fluid drainage of amniotic fluid through a sealed, sterile tube.
- Step 4 Aseptic drainage of amniotic fluid is done directly into bladder collection vessel until procedure completion. Average time for procedure is 90 seconds.
- Step 5. Transfer collection vessel via sterile handling procedures to Lab for purification via filtration through a sterile mesh gauze pad to remove residual vemix and other larger particulates.
- Step 6 Transfer purified amniotic fluid into sterile conical tubes.
- Step 7 Again, using aseptic techniques, pipette 1 cc or 5 cc aliquots of amniotic fluid into sterile cryo-vials.
- Step 8 Seal cryo-vials, then attach prepared labels onto each cryo-vial.
- Step 9 Transfer cryo-vials into pre-labeled, sterile packages.
- Step 10 Record specimen data including assigned lot number on lab requisition form. Specimen Storage
- AmmoTechTM should be stored until ready for use in original packaging at 4°C or room temperature until the expiration date printed on the vial is reached.
- the tattoo area is first wiped with an antiseptic agent to clean the skin and remove any excess blood.
- the antiseptic agent may be for example, Bactine ® (Wellspring Pharmaceutical Corporation; Sarasota, Florida), which comprises the active ingredients benzalkonium chloride and lidocaine hydrochloride.
- the amniotic fluid composition is then topically applied, for example using a specialized dropper vial and a sterile synthetic glove, to the tattoo area.
- the amniotic fluid composition is slowly applied a few drops at a time onto the cupped, gloved hand of the administrator and then softly worked into the skin until the tattoo is sufficiently saturated.
- the tattooed area is then fully covered with a bandage. The bandage is to be removed no later than 12 hours post procedure.
- the amount of amniotic fluid composition applied to the tattoo area varies with the size of the tattoo.
- a micro tattoo that is about 1 to 2 square inches in diameter (about 6.5 cm 2 to about 12.9 cm 2 )
- a small tattoo that is about 2 to 4 square inches in diameter (about 12.9 cm 2 to about 25.8 cm 2 )
- a medium tattoo that is about 4 to 6 square inches in diameter (about 25.8 cm 2 to about 38.7 cm 2 )
- a large tattoo that is about 6 to 12 square inches in diameter (about 38.7 cm2 to about 77.4 cm 2 )
- about 1 mL of amniotic fluid composition is applied.
- amniotic fluid composition For larger tattoos that are 12 to more than 24 square inches in diameter (about 77.4 cm 2 to more than about 154.8 cm 2 ), about 2 mL or more of the amniotic fluid composition is applied as necessary for thorough coverage of the tattoo area.
- the volume of amniotic fluid composition applied may be adjusted according to specific skin type and age of the subject.
- the current industry standard outcomes of a tattoo procedure are a healing time of the tattoo area of about 2 to 3 weeks and bleeding and w eeping time of the tattoo area of about 12 to 36 hours after completion of the tattoo procedure.
- the application of AmniotechTM has shown improved outcomes of the healing process after completion of the tattoo procedure, with reduced inflammation and pain of the tattoo area, and reduced bleeding and w eeping time of the tattoo area to about 1 to 12 hours after completion of the tattoo procedure.
- the application of AmniotechTM appeared to mitigate the immune response, with healing beginning within 1 to 24 hours after completion of the tattoo procedure, depending on size, style and length of time being tattooed.
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Abstract
Disclosed herein are compositions and methods for enhancement of tattoo vibrancy by preservation of color, clarity and contrast sharpness over time. The disclosed methods comprise application of an amniotic fluid composition to freshly tattooed skin.
Description
COMPOSITION AND METHOD FOR ENHANCING TATTOO VIBRANCY
CROSS-REFERENCE
[001] This application claims the benefit of U.S. Provisional Patent Application No. 63/215,840, filed June 28, 2021, said application is incorporated herein by reference in its entirety for all purposes.
BACKGROUND
[002] Tattooing is a well-known and widespread practice of marking or decorating skin. It is accomplished by injection of ink into small holes in the skin, more specifically into the upper layer of the dermis. To do so, typically pricking needles that penetrate the natural (epidermal) skin barrier are used. Tattoo ink is a suspension of pigment particles in a liquid carrier, which is usually a solution of water, glycerin and alcohol. The colorant in tattoo ink is derived from organic and inorganic pigments that cover a wide range of colors. The liquid carrier may also contain additives such as binders, surfactants, preservatives, and thickening agents. A fraction of the injected colorant stays in the dermis as particles. The light absorption of these particles within a specific spectral range results in the colors of the tattoo.
[003] At first view, the injected tattoo colorants seem to stay in skin forever. However, three major mechanisms may reduce the concentration of colorants initially placed in the skin.
First, part of the colorant may leave the skin with the bleeding during or directly after tattooing. Second, part of the colorant may be transported away from the skin via the lymphatic or blood vessel system. Third, part of the colorant is decomposed months or years after tattooing because the pigments in the dermis are repeatedly exposed to different light sources, in particular, solar radiation, including UV radiation. (Serup J, KlugerN, Baumler W (eds): Tattooed Skin and Health. Curr Probl Dermatol. Basel, Karger, 2015, vol 48, pp 176- 184. doi: 10.1159/000369222).
[004] Although aftercare protocols such as the use of sunscreen or sun protective clothing can be used to preserve the tattoo, the loss of colorant remains a significant problem.
SUMMARY OF THE INVENTION
[005] One aspect of the invention is a method for preserving the visual aesthetics of a tattoo, such as color, clarity and/or contrast sharpness, in a tattoo. The method comprises topically administering to the tattoo area a composition comprising amniotic fluid composition.
[006] The method can be used for maintaining the vibrancy of tattoos in both human and
non-human subjects. Further, the method can be applied to a variety of tattoo areas, including decorative tattoos, tattoos applied as permanent make-up, and tattoos used to camouflage scars.
[007] In another embodiment, a composition comprising amniotic fluid is topically applied to a tattoo area to enhance tattoo stability.
[008] Other objects and features of the invention will be in part apparent and in part pointed out hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[009] FIG. 1 is a cross-section illustration of human skin anatomy by Sheeler et al. (Sheeler, P. and Bianchi, D.E. Cell Biology - Structure, Biochemistry, and Function, 2nd Edition.
Wiley & Sons, Inc. 1983).
DETAILED DESCRIPTION
[010] Humans have marked their bodies with tattoos for thousands of years. Tattoos have been used not only as decorative markings for adornment, but also, as amulets, status symbols, signs of religions belief and even for therapeutic benefit. Nowadays, tattooing has become very popular worldwide, and black and multicolored tattoos can be found on almost all parts of the human body. Tattooing is also a widely used technique to mark livestock, wildlife, and other animals and dates back to at least 2000 B.C., when Egyptians marked their cattle to prevent theft.
[011] A tattoo pattern may comprise thick lines, thin lines, and color areas. Numerous types of machines used for tattoo lines, color or shading have been developed over the years including dual coiled machines, single-coil machines, rotary machines and hybrid machines. Conventional tattoo machines comprise a reciprocating needle that moves up and down, and m many cases, within a tubular or cylindrical structure that carries ink into the skin of an individual during the process of having a tattoo drawn on the individual's skin. The reciprocating needle typically punctures the skin at a high rate of frequency. Tatoo machine needles are installed in the machine and dipped in ink, which is sucked into the machine's tube system.
[012] As shown in FIG. 1, adult human skin is a layered organ consisting of an epidermis and a dermis. The epidermis is the most superficial layer of the skin and is classified into several layers. The dermis is composed of two layers, the papillary and reticular layers. The skin also contains hair follicles, glands, and nerve endings responsible for the sense of touch
and pain. In addition to these two layers, the hypodermis, which is sometimes considered a layer of skin, lies beneath the dermis and is composed mainly of adipose tissue. (Kawasumi et al, Wound Healing in Mammals and Amphibians: Toward Limb Regeneration in Mammals. Current Topics in Microbiology and immunology, December 2.012, DOT: 10.1007/82 2012 305).
[013] In the course of the tattooing process, superficial pricking deposits pigments into the epidermis and dermal layers of the skin, especially the papillary and reticular dermis This causes superficial dermal capillary damage and blood droplets covering the skin. The pierced skin reacts by getting red and inflamed (erythematosus) followed by swelling (edematous). This reaction subsides within a few hours. Over the next few days, the superficial and regenerative basal layer of the epidermis peels off until only pigment in the dermis remains. The superficial layer will regenerate, and pigment will be seen in the dermis through the overlying epidermis.
[014] Complete regeneration of the epidermis will be complete within 2 weeks, but the body will react to pigment in the tattoo ink as a foreign body. The body’s response to this invasion is to mobilize macrophages as part of the initial immune recognition to foreign particles. Dermal macrophages will engulf a fraction of the pigment particles and carry them into dermal lymphatic. Thus, the elimination of pigment particles can occur during the first days of healing. After healing, it is thought that the remaining pigment particles are stored in dermal macrophages and fibroblasts. (Strandt H, et al, Macrophages and Fibroblasts Differentially Contribute to Tattoo Stability, Dermatology, 2021, 237:296-302).
[015] Tattoos are generally considered permanent, and the removal of unwanted tattoos may lead to scarring and other side effects. Nonetheless, the demand for safe and effective ways of tattoo removal has led to methods including laser technology, dermabrasion, saiabrasion, surgical excision and cryotherapy, laser treatment to date is the gold standard for removing unwanted tattoos.
[016] Less well studied are methods to inhibit loss of color in tattoos. Dark colors like black, blue and gray inks tend to be more fade resistant than lighter and brighter colors, which may need to be design touched or covered up in a few years. The fading process is typically accelerated by sun exposure, so people may apply sunscreen or sun protective clothing to protect their tattoos.
[017] it has been surprisingly discovered that application of a composition comprising amniotic fluid to the tattoo area after initiation of the tattoo procedure, such as approxima tely die mid-point of the procedure, and after the needling procedure inhibits color loss from the
tattoo. In fact, application of an amniotie fluid composition to a freshly needled tattoo maintains the tattoo ink's color, clarity and contrast sharpness over both the short term and long term.
[018] it has also been discovered that the skin wound(s) caused by the needling process heals more rapidly after application of the amniotie fluid composition to the tattoo area compared to tattooed skin that is not treated according to the invention.
[019] In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area during the tattoo procedure and/or after completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area during the tattoo procedure and after the completion of the tatoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area during the tattoo procedure or after the completion of the tatoo procedure. In one embodiment of the invention, the amniotie fluid composition is not applied to the tattoo area during the tatoo procedure. In one embodiment of the invention, die amniotie fluid composition is not applied to the tattoo area after the completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area approximately at the mid-point of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area approximately at the mid-point of the tattoo procedure and after tine completion of the tattoo procedure. In one embodiment of die invention, the amniotie fluid composition is applied to the tattoo area at the mid-point of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area at the mid-point of the tattoo procedure and after the completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area before the end of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area before the end of the tattoo procedure and after the completion of the tattoo procedure,
[020] In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area within 5 hours after completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area within 4 hours after the completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area within 3 hours after the completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area within 2 hours after the completion of the tattoo procedure. In one embodiment of the invention, the amniotie fluid composition is applied to the tattoo area within 1 hour
after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 30 minutes after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 20 minutes after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition 1s applied to the tattoo area within 10 minutes after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 5 minutes after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 4 minutes after the completion of the tattoo procednre. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 3 minutes after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 2 minutes after the completion of the tattoo procedure, in one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area within 1 mi mite after the completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area immediately after completion of the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area during any stage of the healing process following the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area during any stage of the healing process of the wounds resul ting from the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area before the completion of the healing process. In one embodiment of the invention, the amniotic fluid composition is applied to the tattoo area before the completion of the healing process of the wounds induced by the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition enhances the healing of the tattoo area.
[021] in one embodiment of the invention, the amniotic fluid composi tion is applied to the tattoo area. In one embodiment of the invention, the amniotic fluid composition is directly applied the tattoo area. In one embodiment of the invention, the amniotic· fluid composition is indirectly applied the tattoo area. In one embodiment of the invention, the amniotic fluid composition is applied more than once to the tattoo area. In one embodiment of the invention, the amniotic fluid composition is applied at least once to the tattoo area, in one embodiment of the invention, the amniotic fluid composition is applied at least twice to the tattoo area.
The means by which the amniotic fluid composition is applied to the tattoo area is not
particularly' limited. It can be applied, for example, by rubbing it into the tattoo area with a gloved hand. The amniotic fluid composition can also be applied with specific applicators such as a dropper or a spray or any other form of applicator.
[022] The location of the tattoo in the inventive method is not particularly limited. The tattoo can be located in an exposed area, such as on the neck, collarbone, shoulders, chest, ribcage, abdomen, upper arm, forearm, wrist, edge or top of hand, finger, upper back, lower back, upper thigh, ankle, foot, earlobe, behind the ear, hairline, perns, vagina, breasts, anus, male and female genitalia, or the like.
[0231 The amniotic fluid composition can be applied to a tattoo of any color or mixture of colors. The most common color of a decorati ve tattoo is black, and followed by blue, green, red, yellow, and orange. All of these colors have different wavelength absorption, ranging from about 420 run to about 800 nm.
[024] The pigment particles used to create color in tattoo ink include both inorganic and organic compounds. Organic pigments are the main components of colored tattoo ink and include, for example, alizarin (crimson), azo pigments (yellow, orange and red), phthalocyanine (bine and green) and quinacridone (red-violet). Carbon (soot or ash) is used for black pigment. Commonly used inorganic pigments include titanium dioxide (white) and iron oxides (red, brown, and dark colors), in addition, fluorescent ink is used not only in decorative tattoos, but also for tattoos used in medical procedures conducted under dim light, and for animal tattoos to facilitate ease of identification at night or in laboratories. In an embodiment, the tattoo is applied with ink comprising an organic pigment, an inorganic pigment, or mixtures thereof. In an embodiment, the tattoo is applied to as a decorative marking. In an embodiment, the tattoo is applied to a human subject as a decorative marking. [025] Pigment particles in tattoos range in size from about 1 nm to about 1 μm. Colored and black pigments are particularly rich in nanomaterials (1 nm to 100 nm) whereas white pigments mainly contain particles larger than 100 nm.
[026] In an embodiment of the invention, the amniotic fluid composition is applied to tattoos used as permanent makeup. Permanent makeup is facial tattooing in which colorants are placed in the skin to mimic normal make-up. Permanent makeup tattoos are increasingly popular and include, for example, eyebrow tattoos (i.e., microblading), lip tattoos (i.e., lip blushing), as well as eyeline and lash line tattoos.
[027] In an embodiment of the invention, the amniotic fluid composition is applied to a tattoo used to mask a scar. In an embodiment of the invention, the amniotic fluid composition
is applied to a tattoo used to camouflage a scar. Flesh-colored tattoos cars be used to mask a scar or to reconstruct the nipple-areola complex after mastectomy.
[028] After letting the amniotic fluid composition reside on the tattoo and be absorbed by the skin for about 5 minutes, the tattoo area is covered with a clean, dry bandage to support the tissue, protect the wound from external trauma and contamination, and promote healing. The bandage used to cover the tattoo area includes any medical grade bandage useful for minor skin wounds, such as sterile gauze, Tegaderm™ Transparent Dressing, or Saniderm® Tattoo Aftercare Bandage. The bandage must be large enough to cover the entire tattoo area as well as an inch or more of the surrounding skin. In an embodiment, the bandage is LamellaRap®.
[029] In another embodiment of the invention, a bandage impregnated with amniotic fluid is directly applied to the tattoo area immediately after the needling procedure.
[030] The tattoo process creates a controlled injury to the dermis layer of the skin through the needling process. Without intending to be bound by theory, it is believed that the amniotic fluid aids in repair and regeneration of skin tissues along with providing increased binding sites for ink to permanently remain fixed within the dermis. The amniotic fluid composition is rich in protein-based growth factors, many of which are bound onto cell membranes and within the extracellular matrix connective tissues after wound repair processes have restored cell and tissue integrity. Once the ink pigment particles are tightly bound to cell membranes and connective tissues, macrophages cannot engulf or remove the particles.
[031] The amniotic fluid composition comprises human amniotic fluid in any acceptable vehicle or carrier for topical use. Many such vehicles for topical administration are known in the art and include, but are not limited to, solutions, lotions, emulsions, gels, wipes, sticks, sprays, oils, creams, and the like. In an embodiment, the amniotic fluid composition is a solution.
[032] In embodiments, the amniotic fluid composition further comprises additives used in skin care products, including but not limited to moisturizers, antioxidants, vitamins, emollients, antimicrobial preservatives, anesthetic agents, anti-inflammatory agents, and brightening agents. Incorporation of additives into the human amniotic fluid composition may be desirable, for example, is the subject getting tattooed has dry or sensitive skin. In an embodiment, the amniotic fluid composition comprises one or more additives selected from the group consisting of antioxidants, vitamins, emollients, lubricants, antimicrobial preservatives, anesthetic agents, anti-inflammatory agent, and brightening agents.
[033] In an embodiment, the amniotic fluid composition comprises sterile purified human amniotic fluid. In an embodiment, the amniotic fluid composition consists essentially of sterile purified human amniotic fluid. In an embodiment, the amniotic fluid composition consists of sterile purified human amniotic fluid. In one embodiment of the invention, the amniotic fluid composition does not comprise any cell.
[034] In an embodiment, the amniotic fluid composition is applied to preserve the visible esthetics of a tattoo. In an embodiment, the visible esthetics of a tattoo are the color, clarity and contrast sharpness of the tattoo. In an embodiment, the visible esthetics of a tattoo are the color, clarity or contrast sharpness of the tattoo.
[035] In an embodiment, the amniotic fluid composition is AmnioTech™ (Instinktive, LLC; Salt Lake City, UT), a sterile, purified natural product free from preservatives. Other commercially available products derived from human amniotic fluid (HAF) include, but are not limited to PalinGen® (BioPro; Port Huron, MI), FloGraft® (Applied Biologies; Scottsdale, AZ), Genesis Amniotic Fluid (Genesis Biologies; Irvine, CA), Amnion™ (Arthrex, Inc.; Naples, FL), and Zofin™ (Organicell Regenerative Medicine, Inc. (Miami, FL).
[036] Amniotic fluid composition from human amniotic fluid contains naturally produced growth factors and active biologic agents such as cytokines, electrolytes, enzymes, nucleic enzymes, hormones, hyaluronic acid, lipids, and proteins. It comprises for example, hyaluronan, platelet-derived growth factor bb (PDGF-bb), bone morphogenetic protein 2 (BMP-2), transforming growth factor bΐ (TGF-bI), interleukin 8 (IL-8), and vascular endothelial growth factor (VEGF).
[037] In an embodiment, the amniotic fluid composition can also be derived by aseptic processing of human amniotic fluid obtained during a Cesarian Section surgical procedure. In an embodiment, the amniotic fluid is human amniotic fluid. In an embodiment, the amniotic fluid is sterile. In an embodiment, the amniotic fluid is fdtered. In an embodiment, the amniotic fluid is sterile and filtered.
[038] In an embodiment, the amniotic fluid composition is applied to the tattoo on a human subject. The human subject may be a male or female.
[039] The amniotic fluid composition can also be applied to the tattoo of an animal marked for identification. Cattle, horses, dogs, rats, turkeys, chinchillas, rabbits, foxes, fish, monkeys, and alligators are but a few of the animals that are marked with tattoos for identification purposes. In embodiments, the amniotic fluid composition is applied to the tattoo on a domesticated animal such as a tattoo on livestock (e.g., cattle, sheep, goats, horses, pigs, etc) or pet animals (e.g, dogs or cats). In embodiments, the amniotic fluid composition is applied
to the tattoo on a wild animal (e.g., laboratory animals; zoo animals; and wildlife). Common sites for tattooing animals are the pinna of the ear, the inside of the lip, the inside of the thigh, the chest, the bottom of the foot, the wing, or tail. The tattoo is typically applied in green ink to a lightly pigmented and relatively hairless site or to a tattoo site that has been shaved.
[040] A clinical assessment can be performed after application of the amniotic fluid composition to the tattoo area using a modified Fitzpatrick skin type and Kirby-Desai scale scoring system. The Kirby-Desai scale was developed originally to assess tattoo-removal treatments. In the Kirby-Desai scale, numerical values are assigned to six parameters: Fitzpatrick skin type, location, color, amount of ink, scarring or tissue change, and layering. Parameter scores are then added to yield a combined score that will show the estimated number of treatments needed for successful tattoo removal. (Kirby et al, The Kirby-Desai Scale: A Proposed Scale to Assess Tattoo-removal Treatments. J Clin Aesthetic Dermatol. 2009, 2(3):32-37).
[041] Evaluation of the tattoo area post treatment with the amniotic fluid composition is typically done after about 24 hours, 48 hours, 72 hours, 5-7 days, and then 2-3 weeks.
[042] In addition to assessing color change by the naked eye, it is also possible for the color change in a tattoo to be machine read. For example, an optical imager may include a digital camera to take a picture that a computer can process to determine the color or colors in the tattoo. Alternatively, the optical imager may include a spectrophotometer that can measure absorbance of light of the tattoo to determine what the color of the tattoo is at a given point in time. (See, Peppou et al, US 2007/0055499).
[043] To permanently integrate and stabilize tattoo ink, amniotic fluid growth factors contain binding agents such as cadherins that increase surface adhesion onto dermal cells and tissues (Maitre & Heisenberg, 2013). These binding agents tend to have an affinity to proteins and fibrous tissues such as those found in collagen and fibronectin. Once the ink particles are bound tightly to cell membranes and connective tissue matrices, macrophages cannot engulf nor remove the ink. Commonly found natural binding agents within the dermis are fibroblasts. A related family group of fibroblast cell growth factors (FGF-4, 6, 7, 9, 21) are included in amniotic fluid to augment those naturally found in the dermis. Ink pigment particles have been shown to bind to the surfaces of fibroblast cells. Fibroblasts are the most common cells of connective tissues, and they are mobilized in wound repair to synthesize collagen. In one embodiment of the invention, the amniotic fluid composition mitigates the immune system. In one embodiment of the invention, the amniotic fluid composition reduces the inflammatory response induced by the tattoo procedure. In one embodiment of the
invention, the amniotic fluid composition comprises one or more binding agents that bind to the ink particles, thereby reducing the immune response induced by the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition comprises one or more binding agents that bind to the ink particles, thereby reducing the inflammatory response induced by the tattoo procedure. In one embodiment of the invention, the amniotic fluid composition reduces weeping of the tattoo area. In one embodiment of the invention, the amniotic fluid composition maintains the integrity of the newly applied ink. In one embodiment of the invention, the amniotic fluid composition allows for shorter recovery time of the tattoo area than with a conventional tattoo procedure. In one embodiment of the invention, the amniotic fluid composition allows for reduced aftercare of the tattoo area than with a conventional tattoo procedure.
[044] In another embodiment, a composition comprising amniotic fluid is topically applied to a tattoo area to enhance tattoo stability.
[045] When introducing dements of the present invention or the preferred embodiment(s) thereof the articles “a”, “an”, “the”, and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including” and “having” are intended to he inclusive and mean that there are additional elements other than the listed elements.
[046] The term “tattoo” as used herein may include a pattern in skin produced by injecting ink and/or other ink elements into the skin. Each ink element may include any of a variety of substances that may be applied at or into an injection site on skin of an animal.
[047] The area of the skin at which the tattoo is formed may be referred to as “the tattoo area” or “injection site”.
[048] The layer or depth of the skin to which each ink element is injected may include epidermis, dermis, or subcutis of the skin, substructures of the epidermis such as stratum lucidum, stratum granulosum, stratum spinosum, stratum mucosum, stratum germinativum, stratum comeum, or other substructure of the epidermis, particular regions of the dermis such as a papillary region, reticular region, or other region of the dermis, or other particular layers, substructures, or regions of the skin.
[049] The term “subject”' as used herein includes humans and non-human animals. In embodiments, the non-human is a pel animal, a livestock animal, a laboratory animal, a zoo animal, or a wild animal.
[050] Having described the invention m detail, it will be apparent that modifications and variations are possible without departing from the scope of the invention defined in the appended claims.
[0511 As used herein, the term "about” means a range of values including the specified value, which a person of ordinary skill in the art would consider reasonably similar to the specified value. In embodiments, about means within a standard deviation using measurements generally acceptable in the art. in embodiments, about means a range extending to +/- 10% of the specified value, in embodiments, about includes the specified value.
EXAMPLES
[052] The following non-limiting examples are provided to further illustrate the present invention.
Example 1: General Method for Amniotic Fluid Collection and Storage [053] A general method for the collection and storage of up to 500 cubic centimeter (cc) human amniotic fluid during a cesarean section surgical procedure is described. It does not cover shipping, testing or analysis of these specimens. All health care providers and technicians are expected to be trained and follow universal precautions when handling biological or hazardous materials.
[054] Materials on site include the following: (1) 18-gauge IV angiocatli; (2) variable pipette (1 cc accuracy).
[055] Materials supplied in amniotic fluid packaging kit: (1) 15 x 60 ec conical tubes; (2) 500 x 1.8 cc cryo-vials; (3) 50 x 8.0 cc cryo-vials; and (4) sterile pipete tubes of appropriate capacities.
Amniotic Fluid Collection during Cesarian Section
[056] Step 1. Before initiating procedures make sure collection supplies, labels and forms are in the room, ready and within easy reach.
[057] Step 2. After reflecting the bladder flap of the expandable drainage collection vessel, manually elevate fetal presenting part.
[058] Step 3. Insert IV angiocath through lower uterine segment avoiding placenta, withdraw' the sharp leaving only the soft plastic tubing in the uterus for passive-siphon fluid drainage of amniotic fluid through a sealed, sterile tube.
[059] Step 4. Aseptic drainage of amniotic fluid is done directly into bladder collection vessel until procedure completion. Average time for procedure is 90 seconds.
[Q60] Step 5. Transfer collection vessel via sterile handling procedures to Lab for purification via filtration through a sterile mesh gauze pad to remove residual vemix and other larger particulates.
[061] Step 6. Transfer purified amniotic fluid into sterile conical tubes.
[062] Step 7. Again, using aseptic techniques, pipette 1 cc or 5 cc aliquots of amniotic fluid into sterile cryo-vials.
[063] Step 8. Seal cryo-vials, then attach prepared labels onto each cryo-vial.
[064] Step 9. Transfer cryo-vials into pre-labeled, sterile packages.
[065] Step 10. Record specimen data including assigned lot number on lab requisition form. Specimen Storage
[066] AmmoTech™ should be stored until ready for use in original packaging at 4°C or room temperature until the expiration date printed on the vial is reached.
Example 2: General Method for Application of Amniotic Fluid Composition to a Fresh Tattoo
[067] The general method for application of the amniotic fluid composition mid-tattoo (during the tattooing procedure) and after completion of a tattoo is as follows.
[068] The tattoo area is first wiped with an antiseptic agent to clean the skin and remove any excess blood. The antiseptic agent may be for example, Bactine® (Wellspring Pharmaceutical Corporation; Sarasota, Florida), which comprises the active ingredients benzalkonium chloride and lidocaine hydrochloride.
[069] The amniotic fluid composition is then topically applied, for example using a specialized dropper vial and a sterile synthetic glove, to the tattoo area. Following protocol and procedure, the amniotic fluid composition is slowly applied a few drops at a time onto the cupped, gloved hand of the administrator and then softly worked into the skin until the tattoo is sufficiently saturated. After a timed period of 5 minutes post treatment, which allows time for the amniotic fluid composition to be absorbed by the skin, the tattooed area is then fully covered with a bandage. The bandage is to be removed no later than 12 hours post procedure.
[070] The amount of amniotic fluid composition applied to the tattoo area varies with the size of the tattoo. In general, for a micro tattoo that is about 1 to 2 square inches in diameter (about 6.5 cm2 to about 12.9 cm2), a small tattoo that is about 2 to 4 square inches in diameter (about 12.9 cm2 to about 25.8 cm2), a medium tattoo that is about 4 to 6 square inches in
diameter (about 25.8 cm2 to about 38.7 cm2), and a large tattoo that is about 6 to 12 square inches in diameter (about 38.7 cm2 to about 77.4 cm2), about 1 mL of amniotic fluid composition is applied. For larger tattoos that are 12 to more than 24 square inches in diameter (about 77.4 cm2 to more than about 154.8 cm2), about 2 mL or more of the amniotic fluid composition is applied as necessary for thorough coverage of the tattoo area. The volume of amniotic fluid composition applied may be adjusted according to specific skin type and age of the subject.
[071] Numerous modifications and variations of the present invention are possible in light of the above teachings, it is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein. All patents and other references mentioned above are incorporated in full herein by this reference, the same as if set forth at length.
[072] The current industry standard outcomes of a tattoo procedure are a healing time of the tattoo area of about 2 to 3 weeks and bleeding and w eeping time of the tattoo area of about 12 to 36 hours after completion of the tattoo procedure. The application of Amniotech™ has shown improved outcomes of the healing process after completion of the tattoo procedure, with reduced inflammation and pain of the tattoo area, and reduced bleeding and w eeping time of the tattoo area to about 1 to 12 hours after completion of the tattoo procedure. The application of Amniotech™ appeared to mitigate the immune response, with healing beginning within 1 to 24 hours after completion of the tattoo procedure, depending on size, style and length of time being tattooed.
Claims
1. A method for preserving the visible esthetics of a tattoo, the method comprising administering to the tattoo area a composition comprising amniotic fluid.
2. The method of claim 1, where the visible esthetics are selected from the group consisting of color, clarity and contrast sharpness.
3. The method of claim 1, wherein the composition comprises purified human amniotic fluid.
4. The method of claim 1, wherein the composition further comprises or more additives selected from the group consisting of antioxidants, vitamins, emollients, lubricants, antimicrobial preservatives, anesthetic agents, anti-inflammatory agent, and brightening agents.
5. The method of claim 1, wherein the tattoo is applied with ink comprising an organic pigment, an inorganic pigment, or mixtures thereof.
6. The method of claim 5, wherein the inorganic pigment and/or organic pigment comprise particles that range in size from about 1 nm to about 1 pm in diameter.
7. The method of claim 1, wherein the tattoo is applied to a human subject as a decorative marking.
8. The method of claim 7, wherein the tattoo is used as permanent make-up or to camouflage a scar.
9. The method of claim 1, wherein the tattoo is applied to a non-human animal.
10. The method of claim 9, wherein the non-human animal is a pet animal, a livestock animal, a laboratory animal, a zoo animal, or a wild animal.
11. The method of claim 1, wherein the composition is applied to the tattoo area during
die tattoo procedure.
12. The method of claim 1, wherein the composition is applied to the tatoo area after completion of tattoo procedure,
13. The method of claim 1, wherein the composition is applied to the tattoo area within 2 minutes after completion of the tatoo procedure.
14. Tire method of claim 1, wherein the composition is applied to the tatoo area within 1 minute after the completion of the tattoo procedure.
15. The method of claim 1 , wherein the composition is applied to the tattoo area immediately after the completion of the tattoo procedure.
16. The method of claim 1, wherein the composition is applied to the tattoo area during and after completion of the tatioo procedure.
17. The method of claim 1 , wherein the composition is applied to the tattoo area approximately at the mid-point of the tattoo procedure.
18. The method of claim 1, wherein the composition is applied to the tattoo area approximately at the mid-point of the tattoo procedure and after completion of the tattoo procedure.
19. The method of claim 1 , wherein the composition is applied to the tattoo area before the completion of the healing process of the wounds induced by the tattoo procedure.
20. The method of claim 1, wherein the composition is applied to the tattoo area approximately at the mid-point of the tattoo procedure and within 2 minutes after the completion of the tattoo procedure.
21. The method of claim 1 , wherein the composition is applied to the tattoo area approximately at the mid-point of the tattoo procedure and within 1 minute after the completion of the tattoo procedure.
22. The method of claim 1, wherein the composition is applied topically to the tatoo area.
23. The method of claim 1 , wherein the composition reduces weeping of the tattoo area.
24. The method of claim I, wherein the composition reduces the inflammatory response induced by the tattoo procedure.
25. The method of claim 1, wherein the composition enhances the healing of the tattoo area.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163215840P | 2021-06-28 | 2021-06-28 | |
| US63/215,840 | 2021-06-28 |
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| WO2023275761A1 true WO2023275761A1 (en) | 2023-01-05 |
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| Application Number | Title | Priority Date | Filing Date |
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| PCT/IB2022/056019 WO2023275761A1 (en) | 2021-06-28 | 2022-06-28 | Composition and method for enhancing tattoo vibrancy |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040109831A1 (en) * | 2002-07-18 | 2004-06-10 | M & M Inx Co. | Cosmetic compositions for the protection and optical enhancement of tattooed skin |
| US20150265508A1 (en) * | 2012-10-15 | 2015-09-24 | Ultra Ink, Llc | Removable Tattoo Ink and the Use Thereof |
| WO2021081540A1 (en) * | 2019-10-24 | 2021-04-29 | Briopryme Biologics, Inc. | Preparation and use of therapeutic hydrogels |
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2022
- 2022-06-28 WO PCT/IB2022/056019 patent/WO2023275761A1/en active Application Filing
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040109831A1 (en) * | 2002-07-18 | 2004-06-10 | M & M Inx Co. | Cosmetic compositions for the protection and optical enhancement of tattooed skin |
| US20150265508A1 (en) * | 2012-10-15 | 2015-09-24 | Ultra Ink, Llc | Removable Tattoo Ink and the Use Thereof |
| WO2021081540A1 (en) * | 2019-10-24 | 2021-04-29 | Briopryme Biologics, Inc. | Preparation and use of therapeutic hydrogels |
Non-Patent Citations (1)
| Title |
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| DAN HUNTER: "Green Soap For Tattoos", 6 February 2021 (2021-02-06), pages 1 - 7, XP093022813, Retrieved from the Internet <URL:https://authoritytattoo.com/green-soap-for-tattoos> [retrieved on 20220810] * |
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