Use of polymeric materials for enlarging human glans and...

Surgery – Miscellaneous – Methods

Reexamination Certificate

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C600S040000

Reexamination Certificate

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06418934

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to the use of the polymeric materials for enlarging a human glans and a method of performing a surgery for enlarging a human glans with any of the said materials.
A sexual intercourse of an animal is a manifestation of the primitive instinct of the animal originating from its instinct of preservation of the species; however humans can have a sexual intercourse quite voluntarily at any time without any estrous cycle, which is a characteristic intrinsic to human alone. It can be hardly denied that the sexual intercourse is a very important part of physical and mental health in their life, not as the instinct of preservation of the species. It is thought that the sexual intercourse is an extremely primitive and fundamental nature of the love for maintaining and advancing the group society of each animal. A certain scholar even said that nothing but the sexual intercourse could make people feel happy both mentally and physically without any adverse effect.
A narcotic for an extremely pleasant sensation is said to give a physical and mental comfort, but it is much deficient in perfectness of satisfaction. Moreover, it goes without saying that its side effects have an enormous evil influence.
According to the old Chinese sexual literatures, a male genital organ can function best only under the following conditions;
first: the genital organ should be stiff;
second: the genital organ should be warm;
third: the glans should be large; and
fourth: the penis should be thick and long.
The old Japanese, Indian or Arabian sexual classics attach great importance to the size of the glans, rather than to the lenghth or the thickness of the penis. That is to say, they thought that a big glans, rather than a long or thick penis, was absolutely important in order for a male genital organ to enhance a pleasant sensation of a female mate and further give a satisfaction to her.
Since the sexual intercourse is thought to be so important, various efforts have been exerted to reinforce the male sexual function. However, most of such efforts have been focused on enlargement of the genital organ, while there has been no attempt to enlarge the glans in thickness.
A male glans is covered with a thin mucosa, and it comprises of corpus spongiosum which is full of blood just below the mucosa without any subcutaneous soft tissue layer existing in the general skin. For that reason, it has been thought that it is impossible to modify the glans shape. It has been, therefore, perceived that no method will be available for enlarging the glans, and such perception has led to no attempt to enlarge the glans so far.
SUMMARY OF THE INVENTION
The present inventor has studied the glans for a long period, and observed the glans histologically. As a result, it has been concluded that any polymeric material harmless to the human body and not well absorbed into the somatic tissue can be transplanted into a layer referred to as the lamina propria mucosae. It functions as a dermal layer of the skin, which is at least 2~3 mm thick between the epithelial layer of the mucosa and the corpus spongiosum in the glans. After transplantation, the radius of the glans corona can be enlarged by 0.5~3.0 mm, preferably 1.0~2.0 mm, and such enlargement of the glans will enable men who are possessed by psychological inferiority complex about their small glans to gain confidence in their sexual life, further giving sexual satisfaction to their female mate by nodular stimulating the vaginal wall during the sexual intercourse.
Under this conclusion, the present invention has been made perfectly.
DETAILED DESCRIPTION OF THE INVENTION
The present invention is described in details as follows;
Polymeric materials harmless to the human body and not well absorbed into the somatic tissue is used in the present invention. It includes collagen, artecoll (trade name), dermalive (trade name), zyplast (trade name), perlane (trade name), hyaluronic acid and restylane (trade name). These materials have been used as an insertion into the human body for removing fine wrinkles or correcting recess regions in the skin, but their use for enlarging the glans have never been examined nor attempted so far.
Description of Available Materials
Collagen is a kind of protein and a constituent element of muscle, bone and skin.
Artecoll is a suspension of polymethyl-metacrylate of a micro global form in 3.5% collagen solution at a ratio of 1:3. The surfaces of the micro small globes are very smooth and uniform, and their purity is high. Each micro globe is 30~40 &mgr;m in diameter.
Hyaluronic acid is a major element constituting the animal tissue, particularly the cartilage of birds. It is a significant component of the bio-tissue which is found even in the plant species.
Dermalive (trade name) comprises soft and non-absorbable fragments of acrylic hydrogel dispersed in hyaluronic acid gel prepared by crosslinking the non-animal hyaluronic acid.
Restylane (trade name) is a consistent elastomer substance which is sterilized and has no pyrogen.
Perlane (trade name) is a peculiar form of the non-animal stabilized hyaluronic acid (NASHA). Perlane does not contain any animal protein.
Zyplast (trade name) contains collagen prepared by crosslinking the cowhide collagen with glutaraldehyde in 0.3% lidocaine solution at a content of 35 mg/ml.
Collagen or hyaluronic acid is used in the state of 1~10% (weight) gel made by dissolving it in water, and preferably in the state of 3~8% (weight) gel.
All the said polymeric materials available for the present invention shall have neither bacteria nor pyrogen therein. It is desirable to transplant any of the said materials by using an injector. The said materials are already used for removing fine wrinkles between one's eyes, dimple scars, wrinkles in the eye rims, facial scars, etc. The said polymeric materials are commercialized in the form of one dose of injection set.
Restylane delays absorption of hyaluronic acid in vivo by crosslinking hyaluronic acid, while zyplast delays absorption of collagen in vivo by crosslinking collagen with glutaraldehyde.
Histological Region for Injection
Any of collagen, restylane, zyplast and hyaluronic acid is usually transplanted by injecting it into the dermis layer.
It is already in public domain that artecoll or dermalive shall be injected into the subdermal region which is a boundary layer between the derma and the subcutaneous fat.
It is also in public domain that if the said transplantation is conducted, with collagen or hyaluronic acid, or crosslinked derivatives of collagen and hyaluronic acid are slowly absorbed in vivo. However, in case of artecoll or dermalive, it may cause the cicatricial tissue, which can keep any filled volume by generating the fibrous tissue from 2~3 months after such transplantation. Consequently, This can cause side effects such as swelling or hardening in the periphery of the transplanted region, and such deformity shall be removed by a proper surgery.
Accordingly, in case artecoll or dermalive is transplanted into the derma layer, polymethyl-metacrylate or acrylic hydrogel thereof may show through derma layer. Also, if the cicatricial tissue resulting from such transplantation is formed excessively, it may get nodular irregularity. Therefore, artecoll or dermalive shall not be transplanted into the derma layer, but into the subdermal region which is a boundary layer between the derma and the subcutaneous fat. If artecoll or dermalive is transplanted, the fibrous connective tissue is generated around polymethyl-metacrylate or acrylic hydrogel thereof, and then, fibrin is formed to generate the cicatricial tissue and consequently, the transplanted region may get to be nodulated.
However, this side effect is rather a merit in the plastic operation for enlarging the glans, because it can enhance a sexual satisfaction.
If any of the said materials for enlarging the glans is transplanted into the lamina propria mucosae just below the mucosa surrounding the glans, the circumference of the glans is increased by the t

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