STATEMENT AS TO THE RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

(0001] This invention was not made with U.S. government support.

FIELD OF THE INVENTION

[0002] This invention relates to a method of the treatment eye lids with nonsurgical blepharoplasty by injection to reverse skin tenting and upper eyelid overhang and lower lid laxity.

BACKGROUND

[0003J Overhang and tenting of the skin in the upper and lower lids of the eyes are unique phenomena that can occur in individuals that are not of an advanced age. The skin in the upper and lower lids of the eyes can be resistant to eye creams for the reduction of the presentation of skin tenting, overhang and laxity. There are no approved or rigorously evaluated non-surgical alternatives for treatment of these conditions directly at the source, i.e. the upper and lower lids. Surgical alternatives include various forms of upper and lower lid blepharoplasties where incisions are made and fat is surgically teased out of candidates. All surgeries, however, are associated with the known risks of anesthesia, infection, bleeding, bruising, scarring, as well as the possibility of poor outcome and the expected discomfort and "down-time" for the patient. Presently, there are no injections for the upper and lower lids that reverse skin tenting, laxity, overhang, sag or puffiness. There has been hesitation in the market to date for injections into the tissue proximal to the orbits of the eyes. Injections into this anatomical sight increase the risk of causing blindness in the patient. None of the cosmetic substances currently in the cosmetic injection market can be injected into the eye lids or the tissue proximal to the orbits of the eyes. There is a need in the market, therefore, for a non-surgical alternative to address skin conditions of the eye lids which does not pose the risk of causing blindness. A citrate solution however, could be used to successfully treat skin conditions of the eye lids without the risk of causing blindness in patients. The demand for nonsurgical eye correction is very high in the cosmetic market. [00041 In spite of procedural risks, the growing appeal of cosmetic medical treatment of said procedures is a testament to the psychological importance of body image and the beneficial outcomes of these procedures, as perceived by the patients who seek them. However, the significance of a product that corrects signs of peri-orbital aging with little to no risk is significant.

BRIEF DESCRIPTION OF THE INVENTION

[00051 The present invention is directed to a method for the non-surgical reduction of localized loose skin in the upper and lower lids that is associated with the normal aging loss of the integrity of the dermis that supports the epidermis. The upper lid tenting and overhang and lower lid tenting, overhang and laxity can give the appearance of one looking tired when not. In particular, a treatment for skin tenting, lid laxity, sag and overhang in the upper and lower lids of the eyes with an aqueous solution of citric acid with a viscosity consistent with water at 20 to 25°C.

DETAILED DESCRIPTION OF THE INVENTION

[0006] The Invention provides a method for improvement of the tired look of human skin of the eye lids comprising administering citric acid or a salt thereof to a patient in need thereof, wherein the administering is a subcutaneous injection. The method tightens subcutaneous fat via strengthening of wall proteins located in the hypodermis of the skin of the upper and lower eye lids to thereby enhance facial appearance. The injection is, for example, in the form of one or more large blebs or small boluses. The method may also include an additional step of measuring one or more improvements in the appearance of the skin with a measuring device. When the citric acid or salt thereof is placed in the superficial plane or deep plains of subdermal fat, it causes skin tightening by connective tissue contractions, increase support of the subcutaneous tissue, and tensile strength to protein strands below the dermis. The citric acid or salt thereof may be either natural or synthetic. [0007] The compositions, treatment schedules and methods of using said compositions discovered by the inventor effectively remove the effect of tenting or impending tenting of the upper and lower lids. Generally speaking, tenting and impending tenting and tented skin ptosis of the upper and lower lids of the eyes are a well-known beauty problems; problems that can progress to visual impairment if treatment to reverse the presentation of the tented and hanging skin is delayed. In addition, the effect of tightening tented and hanging skin with subcutaneous injections repositions fat and re- compartmentalizes fatty tissue in its more anatomically correct position.

[0008] Citrate constituted with isotonic water and dextrose can stimulate elastin tensile strength below the dermis and above and below the muscle to tighten skin, decrease the appearance of aging, and contour deficiencies, fine lines and wrinkles. Citrate is found in the serum of individuals, but also can be manufactured and processed.

[0009] The composition of the instant application is based on 100 volume percent calculations. In particular, the composition of the instant application is comprised of: 10 volume percent: 3.2 % sodium citrate buffer. In the preferred embodiment, approximately .109 ml of sodium citrate buffer is used. Citric acid, having the formula,

, may also be used.

The 3.2% sodium citrate buffer or citric acid is combined together with

90 volume percent: 36.6 % isotonic water, 45% sodium chloride and 6.4% glycerol with trace electrolytes.

[0010] The invention also encompasses a kit. The kit includes the following items: 1). sodium citrate powder, or a solution thereof, pre-loaded into a 20 cc intravenous vial for dispensing, 2). an 8 to 10 cc syringe of a liquid volume comprising isotonic water, sodium chloride, glycerol and trace electrolytes; and an injector device to reconstitute the dry elements. The injector mixes the ingredients back and forth between two 10 cc syringes until the formula is reconstituted to a dose of 10ml prior to administration.

(0011] The mixture should have a neutral pH prior to injection. In addition, the prepared solution should exhibit the viscosity of water at 20 to 25°C at the time of injection.

[0012] The composition of the instant application for the subcutaneous reversal of skin tenting, sag, lag of the upper and/or lower lid should be administered only by competent plastic surgeons, dermatologists or other medical doctors and their eligible licensed staff. Injections into the sub-dermal fat tissue in patients having skin tenting, sag or lag of the eye lids will tighten and thicken the subdermal fat bands and the hypodermis thereby reducing the appearance of fine lines, wrinkles, and pores of the eye lids.

|0013] Formulations suitable for administration, conveniently comprise sterile aqueous solutions of the active ingredient(s). Preparations may be sterilized by, for example, filtration through a bacteria-retaining filter, by incorporating sterilizing agents into the compositions, by irradiating the compositions, or by heating the compositions.

Preparations can also be manufactured in the form of sterile solid compositions which can be dissolved in sterile water or some other sterile injectable medium immediately before use. The formulation may be presented in unit or multi-dose containers, for example, sealed ampoules or vials.

EXAMPLES

(0014) Prior to treatment, photographs are taken of the patient's eyelids. An initial treatment period involves up to 2 to 3 treatments involving an initial treatment with usually two subsequent follow-up treatments, i.e. a follow-up treatment and a follow-up to the follow-up treatment. When the appearance of the correction of the subcutaneous wall protein deficit of the upper and lower lids is observed, treatment is usually halted. At the initial treatment session, the consultant discusses the intended goals with the patient and then determines if the patient is a candidate for the follow-up to the follow-up treatment. The provider determines the appropriate number of milliliters of citric acid solution to be injected into the defective spaces of the subdermal fat planes; on average a range of 2 mis to 12 mis of citric acid solution is employed. During treatment, a hypodermic need is used to inject the citric acid with sterile water as an aqueous mixture in a micro droplet and microfluidic pattern into the defective space in the orbital lids targeting the preaponeurotic fat pads, medial fat pads, temporal fat pads, medial fat pads as well as the fatty cell layers. The solution immediately reabsorbs into subdermal planes. Residual swelling will be appreciated for 24 hours followed by reabsorption of the solution. The initial, local inflammatory response heals at a varying rate depending on the individual patient with the majority of patients healing completely within two weeks or less. Results from the treatment can be appreciated in 4 to 6 weeks with maximum results in 12 months and beyond. Blood test can be used to monitor the dermal response to the treatment. Before and after photography is used to consult with the recipient in one month, three months, 12 months as recommended visits and a 24-month visit with photography is optional.

(0015] Example 1:

[0016] Example 2:

[0018] Example 4: