Labium majus prothesis and its implant method

Abstract

The application of unilateral or bilateral permanent prostheses to the labium majus in the external genitalia of women for reconstructive and aesthetic purposes may make it appear fuller. The labium majus may lose its fullness and symmetry due to menopause, rapid weight gain and loss, traumas, cancers, and infectious diseases. Aesthetic interventions (e.g., hyaluronic acid filler injection and fat grafting) aiming to provide the labium majus with fullness have become very popular in recent years. The hyaluronic acid filler is used for reconstructive purposes to achieve fullness in labium majus. However, the maximum amount that can be injected is 3 mL, which is often insufficient for the desired outcome and its effect lasts for a maximum of 1 year. Autologous fat grafting is administered by taking 18–120 mL of fat from patients themselves; however, its effect usually lasts 1 to 4 years. The application of a prosthesis will provide labium majus with fullness and this effect will be long-lasting. The outer edge of the prosthesis is convex and the inner edge is concave. In male genitalia, prostheses have been used since 1950 to provide the testicles with fullness. Scientific studies have shown that these prostheses positively affect self-confidence and body perception indices in men.

Description

[0001] DESCRIPTION

[0002] LABIUM MAJUS PROTHESIS and ITS IMPLANT METHOD

[0003] Technical Information

[0004] The labium majus (outer lip) prosthesis is a medical invention in the field of women's health (Figs. 1-6). The aim of using this prosthesis is to provide fullness to the labium majus and to ensure that this effect is long-lasting.

[0005] Current State of the Technique

[0006] The labia majora in the female external genitalia lose their fullness due to weight gain and loss, menopause, vaginal atrophy, cancers, infectious diseases, traumas, or congenitally. Like breast prostheses used in women's breasts, a permanent prosthesis providing fullness can be used for the labium majus for reconstructive and aesthetic purposes (Figs. 1-6).

[0007] The hyaluronic acid filler is used for reconstructive purposes to achieve fullness in labium majus. However, the maximum amount that can be injected is 3 mL and its effect lasts for a maximum of 1 year. Accordingly, repeated applications are needed. Fat grafting is performed using 18-120 mL of fat taken from patients themselves; however, its effect usually lasts for 1 to 4 years.

[0008] Male genital prosthesis have been used to give the testicles fullness since 1950. Research has demonstrated that these prostheses have a positive impact on men's body perception and selfconfidence indices.

[0009] A Brief Description of The Invention

[0010] Prostheses for reconstructive and aesthetic purposes have been used for years to give fullness to the testicles in the male genital area. Similar prostheses have not been developed for women to date. The use of a prosthesis for the labium majus will give it fullness and this effect will be long- lasting, in other words, there will be no need for repeated applications (Figs. 1-6).

[0011] The outer edge of the (Figs. 1,3) is convex and the inner edge is concave. The convex and concave edges meet at the upper and lower poles which have holes (Fig. 5) to fix the prosthesis. Depending on the patient's conditions, these holes can be one or two— one on the top and one on the bottom. The prosthesis can also be produced without fixation holes. Its average length is 6 cm, it is about 1.5 cm wide, and about 1 cm thick in the middle; this thickness decreases toward the poles. The prostheses are produced in different sizes according to the patient's labium majus size. The implant is made of prosthetic materials such as silicone, silicone gel, liquid silicone, or hyaluronic acid gel. The prosthesis can be used symmetrically as a pair (on the right and on the left); it can also be used singly.

[0012] 35

[0013] 5 Figures

[0014] Figure 1 Side view of the implant with concave-convex surface

[0015] Figure 2 Sectional view of the implant with concave-convex surface (Fig. 1)

[0016] Figure 3 Side view of the concave implant with concave-convex surface

[0017] Figure 4 Sectional view of the concave implant with concave-convex surface (Fig. 3)

[0018] Figure 5 Rectangular view of the implant

[0019] Figure 6 Oval view of the implant

[0020] Reference Numbers

[0021] 1 Labium Majus Prosthesis with Concave-Convex Surface: This prosthesis has a convex outer (lateral) edge and a concave inner (medial) edge. The convex and concave edges meet at the upper and lower poles; it has holes at the poles and sides to fix it.

[0022] 2 Thin Labium Majus Prosthesis with Concave-Convex Surface: This prosthesis has a convex outer (lateral) edge and a concave inner (medial) edge. The convex and concave edges meet at the upper and lower poles; it has holes at the poles and sides to fix it.

[0023] 3 Rectangular Labium Majus Prosthesis: This prosthesis has fixation holes at the poles and sides to the implant to fix it.

[0024] 4 Oval Labium Majus Prothesis: This prosthesis has convex lateral and medial edges merging at the upper and lower poles; it has holes at the poles and sides to fix it.

[0025] 5 Fixation Holes

[0026] Detailed Description of the Invention

[0027] The invented prosthesis (Figs. 1,3) has a convex outer edge and a concave inner edge. The convex and concave edges meet at the upper and lower poles. There are fixation holes (Fig. 5) on the poles and lateral edges. These holes may be one on the lower or upper pole only, two on the lower and upper poles, two on the medial and lateral edges only, one on the medial or lateral edges only, three on the lateral edges one of the poles, and four on the medial lateral edges. There are no holes in implants that can be sutured through. The prosthesis can be produced without fixation holes, in other words, as those without needing sutures. Its average length is 6 cm, it is about 1.5 cm wide, and about 1 cm thick in the middle; the thickness decreases gradually toward the poles. These sizes vary according to the size of the patient's labium majus and are produced in different volumes (1- 70 mL) with the same shape. The prosthesis is made of prosthetic materials such as silicone, silicone gel, liquid silicone, or hyaluronic acid gel (Figs. 1,3,5, and 6). It can be used individually or in pairs (right and left). The invention will be produced medically in the form of a prosthesis and will provide a longterm permanent solution for women who demand reconstruction or aesthetics in the external genital labium majus area.

[0028] The prosthesis is implanted by making a 1.5-cm incision one-fourth posterolateral to the labium majus under local sedation or general anesthesia following site disinfection and sterile draping (Figs.

[0029] 1,3,5, and 6). In this incision, a cavity is created by advancing anteriorly through the subcutaneous adipose tissue using a Hegar dilator, ovarian forceps, or a probe. The prosthesis is approximated to the subcutaneous tissue incision line using the dilator through the skin from the caudal or medial side of the labium majus, and PDS 2 / 0 fixation suture is applied. The prosthesis is fixed by applying the suture through the anterior pole or its medial side and moving it into the adipose tissue. The lower pole (posterior pole) is fixed under the skin close to the incision line or under the lateral skin. After achieving hemostasis, The procedure is completed by suturing the subcutaneous tissue using PDS 2 / 0 and suturing the skin using a Vicryl Rapide suture 2 / 0. The same procedure can be repeated contralaterally.

[0030] The prosthesis can be used unilaterally or bilaterally symmetrically (Figs 1,3,5, and 6).

[0031] The deep surface of the prosthesis is flat, the superficial surface (close to the skin) is convex, the outer (lateral) edge is convex, and the inner (medial) edge is concave (Figs. 1,2). It has fixation holes (Fig. 5) on the poles and lateral sides to fix the prosthesis. These holes can be one in the lower or upper pole only, two in the lower and upper pole only, two in the medial and lateral edges, one on the medial or lateral edge only, three on the lateral edge, and one of the poles, and four on the medial and lateral edges. The prostheses through which sutures can pass do not have holes. These can be produced without fixation holes or with a material that does not require sutures for fixation. The prosthesis can be applied unilaterally or bilaterally symmetrically.

[0032] The deep surface of the prosthesis is concave, the superficial surface (close to the skin) is convex, the outer (lateral) edge is convex and the inner (medial) edge is concave (Fig. 3). It has fixation holes (Fig. 5) on the poles and lateral side to be fixed. These holes may be one on the lower or upper pole only, two on the lower and upper pole only, two on the medial and lateral edges, one on the medial or lateral edge only, three in total on the lateral edge, and one of the poles, and four on the medial lateral edges. There are no holes in implants through which sutures can be applied. The prosthesis can be produced without fixation holes or from material that sutures are not applied for fixation. It can be applied unilaterally or bilaterally symmetrically. The prosthesis is rectangular (Fig. 5). The edges of the implant have fixation holes to be fixed. These holes can be one on the upper or lower pole only, two on the upper and lower pole only, two on the medial and lateral edges only, one on the medial or lateral edges, three in total on the lateral edge, and one of the poles, and four on the medial lateral edges. There are no holes in implants through which sutures can be applied. The prosthesis can be produced without fixation holes or from materials that sutures are not applied for fixation. It can be applied unilaterally or bilaterally symmetrically. The lateral and medial edges of the prosthesis are convex and both edges meet at the upper and lower poles (Fig. 6).

[0033] There are fixation holes on the poles and lateral side of the implant to fix it. It may not have fixation holes.

[0034] The prosthesis material is made of silicone, silicone gel-filled, serum saline-filled, silicone encapsulated, silicone elastomer, or a prosthetic material such as hyaluronic acid gel (Figs. 1,3,5, and 6).

[0035] Each prosthesis can be in a volume of 1-70 mL.

Claims

CLAIMS1. The invention is a unilateral or bilateral permanent prosthesis that can be applied to the labium majus in the external genitalia for reconstructive and aesthetic purposes. It is also a technique for its placement. Its major features are as follows:• The prosthesis has convex, concave, rectangular, and oval structures to adapt to different body structures (Figs. 1, 3, 5, and 6).• The prosthesis has five holes for fixation.• The prosthesis can be manufactured without fixation holes.• The prosthesis is implanted by making a 1.5-cm incision one-fourth posterolateral to the labium majus under local sedation or general anesthesia following site disinfection and sterile draping.• In this incision, a cavity is created by moving anteriorly through the subcutaneous adipose tissue using a Hegar dilator, ovarian forceps, or a probe.• The prosthesis is approximated to the subcutaneous tissue incision line using the dilator through the skin from the caudal or medial side of the labium majus, and a PDS 2 / 0 fixation suture is applied.• The prosthesis suitable for fixation is advanced into the adipose tissue and fixed by making a suture through its anterior pole or medial side.• The lower pole (posterior pole) of the prosthesis suitable for fixation is fixed under the skin close to the incision line or under the lateral skin.• The procedure is completed by suturing the subcutaneous tissue using PDS 2 / 0 and suturing the skin using Vicryl Rapide suture 2 / 0 after achieving hemostasis.

2. The labium majus prosthesis mentioned in order 1 is characterized by a convex outer edge, a concave inner edge, and a combination of convex and concave edges at the upper and lower poles (Figs. 1-4).

3. The labium majus prosthesis mentioned in order 1 is rectangular in shape (Fig. 5).

4. The labium majus prosthesis mentioned in order 1 is oval in shape (Fig. 6).

5. The prosthesis mentioned in order 1 is characterized by the presence of five fixation holes at the poles of the implant to fix it (Figs. 1-6).

6. The fixation holes mentioned in order 5 are characterized as single, bottom, or top based on the patient's condition.

7. The prosthesis in order 1 can also be manufactured without fixation holes (Figs. 1-6).

8. The number of fixation holes mentioned in order 5 may be one on the lower or upper pole only, two on the lower and upper poles, two on the medial and lateral edges only, one on themedial or lateral edge only, three on the lateral edge and one of the poles, and four on the medial and lateral edges.

9. The prosthesis mentioned in order 1 is characterized by an average length of 6 cm, a thickness of 1.5 cm, and a central section of approximately 1 cm (Figs. 1-6).

10. The prosthesis mentioned in order 1 varies according to the size of the labium majus of the patient (Figs. 1-6).

11. The prosthesis mentioned in order 1 is made of acid gels such as silicone, silicone gel, liquid silicone, and hyaluronic acid (Figs. 1-6).

12. It is used symmetrically on the right and on the left or singly (Figs. 1-6).

13. The prosthesis mentioned in order 1 is manufactured in a volume of 1-70 mL (Figs. 1-6).

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