Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Tissue
Reexamination Certificate
2001-12-07
2004-12-14
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
Tissue
C623S011110, C623S066100, C128S848000, C128S859000, C433S136000, C433S140000, C606S234000
Reexamination Certificate
active
06830590
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a lip enhancement apparatus and method, more particularly to a mechanism and method for enhancing the appearance of the lips without use of an injection or plastic surgery.
BACKGROUND OF THE INVENTION
In recent years it has become fashionable for people, particularly actresses, to have fuller looking lips. The most common way in which fuller looking lips are attained is through a lip augmentation procedure, and often through the use of collagen
Collagen is a natural structural protein complex found in all mammals. The structure of collagen is complex, but very similar in humans and higher animals, including cattle and pigs. The purified sterile Injectable Collagen used in Cosmetic Plastic Surgery is extracted from cow hides (bovine collagen) and packaged in convenient small quantity syringes. The Injectable Collagen matrix is useful as a filler to build up skin depressions associated with wrinkles, and also as a non-permanent soft tissue augmentation material to highlight the lips, etc.
Because the structure of this bovine collagen is slightly different from human collagen, skin testing of a small quantity is necessary at least one month prior to formal collagen injection treatment to avoid the risk of an allergic reaction. Because the injected Collagen is not exactly the same as native human collagen, the immune system will gradually digest it, preventing permanent incorporation. The Injected Collagen may last for over a year, but in some individuals will only last for several months.
For lips in particular, Collagen treatment is recommended as a preliminary before considering placement of a permanent augmentation material such as Gore-tex strands, Alloderm, or MicroDroplet Fat Injections. Patients who would like a fuller appearance to their lips but are unsure of the permanent results will usually try the collagen replacement therapy first. After liking the fullness created they will have the option of a more permanent procedure such as the Alloderm placement.
Alloderm is highly processed human skin (dermis) that can be grafted or implanted into the upper or lower lip to give your lips a fuller appearance. The treatment with collagen is highly individual. The same amount of collagen that would give fall correction for one person may not be a sufficient amount for another person. Usually, a 1 cc syringe of collagen is used to give adequate correction to the area of concern.
The known risks associated with Collagen Replacement Therapy can be classified into two categories: those associated with the collagen material itself, and those associated with the injection procedure.
The primary known risk of the collagen material is an allergic reaction. About 3% of the population is allergic to bovine collagen. A skin test is done before treatment to help determine whether the patient is allergic to the material. Some physicians will perform the skin test more than once. If the patient is allergic to injectable collagen, treatment should not be done. About 1% to 2% of patients treated will experience an allergic reaction, despite a negative skin test or tests.
This allergic reaction can result in prolonged redness, swelling, firmness and itching or, in rare instances, in formation of an abscess (cyst) that may result in hardness or a scar. These reactions are temporary in nature; however, in a few cases, periodic flare-ups have occurred for more than 24 months.
The primary risk from the injection procedure is bruising and swelling at the injection site. In rare cases, necrosis (tissue sloughing, or shedding, and resulting scab or sear formation) at the injection site may occur.
Some physicians have reported the occurrence of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis (DM), and polymyositis (PM) subsequent to collagen injections, in patients with no previous history of these disorders. A comparison of the observed number of cases of PM/DM in the collagen treated population with an estimate of the expected number of cases suggests an association between collagen injections and PM/DM; i.e., there appears to be a higher than expected incidence of PM/DM in the collagen treated population. However, a causal relationship between collagen injection and the onset of autoimmune disease or systemic connective tissue disease has not been established.
While these risks do not manifest themselves in every patient, many prospective patients choose to not undergo lip augmentation procedures because of fears. Because of these fears, these risks, and the time involved with undergoing lip augmentation procedures, there exists a need for a faster, easier, and less dangerous way of augmenting lips.
SUMMARY OF THE INVENTION
The present invention addresses the foregoing needs by providing an inexpensive system for lip augmentation that is extremely easy to use. The lip enhancer is non-surgical, uses no drugs and can be applied in seconds. It is a clear or flesh colored polymer strip with a strong moisture activated adhesive on one side. A user inserts the lip enhancer between their teeth and their lip with an attached applicator. Once in proper position, the user simply pulls the applicator away. When in place the lip enhancer stretches the inner lip tissue, causing more of the lip to be exposed externally, thus making the lip appear noticeably larger. Users may talk, eat, and drink while using the lip enhancer.
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patent: 6318370 (2001-11-01), Sempere et al.
patent: 6328756 (2001-12-01), Amernick
patent: 6652275 (2003-11-01), Byers
Holden Simon
Palahnuk Nicholas
Blanco Javier G.
Rosenberg Marshall E.
Willse David H.
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