IMPLANTE OF GLUTEO UNIVERSALFIELD OF THE INVENTIONThis invention relates to a prosthesis or implant that has visco-elastic characteristics, more particularly, to an implant that will be inserted in a gluteus in order to increase its volume and modify the shape for aesthetic purposes.
BACKGROUND OF THE INVENTION.
Gluteal prostheses, in particular, are well known in the art, and generally include a cover or sheath and a high viscosity fluid filler or gel, said prostheses are used to enlarge the breasts, buttocks or calf. , because in addition to increasing its volume maintains its normal appearance in the host. Most implants consist of a single compartment filled with said fluid; but inside they have a reticulated structure that is used to give greater stability to the movement of the fluid that is enclosed within the envelope. The closest state of the art is defined by USP No. D477,078; granted to Gutstein on July 8, 2003, where an oval-shaped implant with a textured surface is described; but without rounded contours and without palpation points on the base and front face, it also does not have a contour of palpation between the base and the front face.
U.S. Patent No. 5,824,081, issued to Knapp et al. On October 20, 1998, describes and protects a hydraulic foam tissue implant that simulates the tissue that is intended to be increased or replaced; the implant comprises a cover enclosing a foaming body with fluid filling, the foaming body is an elastomeric material with cells interconnected by ducts where the contained fluid circulates. This implant is used for implants of chest, calf, etc. U.S. Patent No. 3,683,424, issued to Pangman on August 15, 1972, describes and protects a breast implant, which consists of an elastic bag that is adapted to contain a foaming filler together with an amount of liquid inside the cells of the filling. Said cover contains a flexible tube through which the liquid is added at the time of implantation.
BRIEF DESCRIPTION OF THE INVENTIONIt is an object of the present invention to provide a universal prosthesis or implant for the gluteus that eliminates the disadvantages of poor aesthetic results, irregularities, the high incidence of major complications of existing implants. It is another object of the present invention to provide a universal prosthesis or implant for the gluteus that is as close as possible to the tissue of the host body or patient.
It is still an object of the present invention to provide a universal prosthesis or implant for the gluteus, which is inserted under or between the gluteal muscle tissue in order to increase the volume or size of the female gluteus for esthetic purposes. It is yet another object of the present invention to provide a prosthesis or universal implant for the gluteus, of a half-almond shape with rounded contours (oval), constructed of a biocompatible material, with visco-elastic properties, that is, it has a good elastic memory under a deformation produced by an external pressure. It is also another object of the present invention to provide a universal oval-shaped gluteal prosthesis or implant that includes a cover or envelope with palpation elements, such as points and contour line, which is filled with a high viscosity fluid such as a gel. of silicone. It is another object of the present invention to provide a universal oval shaped prosthesis or implant for the gluteus which includes a cover or envelope with palpation elements, such as points and contour line, which is filled with a solid body rigidly as an elastomer of silicone It is still another object of the present invention to provide a universal prosthesis or implant for the gluteus, the half-almond shape of which is complementary and which adapts to the curvature of the gluteal portion in the vicinity of the surface of the implant.
BRIEF DESCRIPTION OF THE FIGURES.
The embodiments of the present invention will be described in greater detail with reference to the appended figures. Figure 1 is a top view of the implant showing the textured and convex surface of the front face, the upper palpation points and the probing line of the contour defining the boundary between the base and the front face. Figure 2 a shows another top view of the half-almond shape of the silicone gel implant, as well as a cross-sectional view showing the lower palpation points of the base, the straight and flat base, and the rounded ends of the bases. upper and lower poles, the contour of the front face, the maximum projection and the maximum extension. Figure 2 b shows another top view of the half-almond shape of the rigid silicone elastomer implant, as well as a cross-sectional view showing the lower palpation points of the concave base, the concave base which is compared to the base of Figure 2 a and that adapts to the shape of the area where it is placed, the rounded ends of the upper and lower poles, the profile of the front face together with the touch points. Figure 3 shows the implant in the position of use, placed in the intramuscular space of the gluteus maximus.
DETAILED DESCRIPTION OF THE INVENTION.
The universal gluteal implant of the present invention comprises a cover or envelope enclosing a filling compound, which provides a hydraulic cushion effect, and which has an elastic memory that allows it to recover its original shape after a deformation that is consequence of the application of external pressure on the surface of the front face of the implant. Both parts, the shell or cover and the filling of the implant are biocompatible, such as, for example, silicone gel and silicone elastomer. Considering the prosthesis provided by the present invention, which is placed in position of use under a surgical operation, said prosthesis has an elastic filling and a cover or sheath that can be of various sizes which are selected at will. The elastic cover acts as a barrier membrane to stop an elastic silicone core inside said envelope; the amount of filling inside said cover varies within the limits of 200 cm3 and up to 600 cm3, with this size and weight allow the surgeon to insert the prosthesis into the tissue of the patient's area adjusting the size for the guest to make movements free simulating the natural movements of the host tissue; For example, if the filling flows slowly in a movement, the gluteus looks very stiff and does not seem like a natural movement and if it flows very fast, the gluteus spreads. The correct placement of the implant within the patient's tissue is also important since it may suffer an inadequate displacement after the operation or already in continuous use. There is a need for the implant to have reference points and edges that allow external examination of the palpation to locate the current position of the implant, thus being able to determine from the outside, if it is in the correct position. With reference to Figure 1, the universal gluteal implant of the present invention is shown in a top view where the front face or convex surface (10) is shown, comprises a cover or shell (1) of silicone elastomer which encloses a composite material body or viscous and flexible mass (2) which can be silicone gel (dimethylpolyxiloxane) or silicone elastomer and which occupies completely the internal space defined by the envelope (1). The shell or shell of the implant is made of an elastomeric or non-elastomeric material, with smooth or textured surface (3), said surface material is biocompatible with the host tissue and chemically stable with the filling material (2) . Preferably the wrapping material is made of silicone elastomeric material; also the filling material is bio-compatible with the host tissue, in this way, the host tissue is protected against the event of rupture of the envelope, any filling material that could migrate out of the envelope, in the event of accidental rupture , it is metabolized and excreted by the host's body. This special form of implant is used, the oval or half-almond shape (10), with a flat base and an upper surface or convex front face, whose special design is suitable for the perfect location in the gluteal area where a increase, the shape of the implant is considered fundamental to achieve the desired aesthetic augmentation and contour for the gluteus, it is also particularly important the rounding of the upper (5) and lower (6) polar ends, at the border between the base and the front face These rounded ends, the palpation point (1) of the upper pole and the three palpation points (2) of the maximum projection of the implant on the front face, the maximum projection line defines two inclination zones on both sides (7) and (8); where the inclination (7) is less pronounced in comparison with the inclination (8), the contour palpation line (4) defines the boundary between the flat or concave base and the front face, characteristics that make the implant object of the present request is novel in relation to implants of the prior art. The palpation points (1) and (2) are protuberances that have a height of 3 mm and 7 mm in circumference; the contour line (4) is a continuous protrusion that has a width of 7 mm and a height of 3 mm, thus forming a contour or belt of palpation; but only in the direction of the upper pole, said elements serve to verify the position of the implant in a post-operative stage. The best results of gluteal augmentation by gluteoplasty are achieved when the implant is placed in the intramuscular space, because it can be covered with a flap of skin that keeps the implant in place and creates pleasant and aesthetic harmony, with soft contours, without irregularities and with low incidence in major complications. The implant of figure 1, comes in several sizes, namely, the boy from 180 to 240 cm3, the medium from 300 to 360 cm3, the large from 420 to 480 cm3, the extra-large from 540 to 600 cm3; the height of the maximum projection covers the interval from 2.7 cm for the small size, up to 4.0 cm for the extra large size, distance taken without considering the height of the touch points, these sizes are applied for the soft gel implants of silicone and for solid silicone elastomer implants, in the latter, although the size is the same, the volume decreases in relation to the silicone gel fillings, however the height of the maximum projection remains the same, the volume decreases sensibly since the base has a concave shape to better adapt to the patient's body; but the edges between the base and the front face, remain unalterable, this to adapt to the surface of the intramuscular space where it will be placed. The silicone gel implant is used in cases of gluteal augmentation where it is not necessary to increase muscle tone, for example, in young patients. The silicone or solid elastomer implant is used in cases where it is necessary to increase muscle tone as well as the gluteal volume, including cases of ptosis and gluteus flaccidity in elderly people, and the selection depends on the clinical determination of the muscular tone. The half-almond design, which is the shape of the implant of the present invention, is specific for the gluteal area where said implant is placed, that is, in the intramuscular space located between the fasciculi of the gluteus maximus muscle.
The sub-muscular space presents difficulties due to its proximity to the sciatic nerve and the consequent possibility of damage. In figure 2 a, the position of the upper palpation points (1) and (2) on the front face and the contour (4) is shown; in the upper pole there is a single palpation point (1) on the front face and a single palpation point (21) on the base; in the line of maximum projection of the front face has three points of palpation (2) on a transverse line that corresponds to the maximum projection and which in turn define the boundary of the slopes (7) and (8) for both sides , also at the base and in contrast to the three points mentioned above there is a single touch point aligned with the central point; In this figure, the top view of an implant (20) filled with silicone gel (24) with a textured surface covering or cover is shown, as well as the width or maximum extension (A) of the implant having the special shape of the implant. half of an almond cut in a horizontal plane, the height of the maximum projection (C) at whose ends are the palpation points (2) and (22), whose length covers the range of 2.7 cm to 4.0 cm (see cross section (23)), where the length (B) of the almond half is also shown, said half has a smooth or textured flat base (25) which has the palpation points (21) and (22) in respective alignment with the upper points (1) and (2) of the front face, said palpation points also have the same size as those of the upper face, that is, height of 3mm and diameter 7mm in the circumference. It is worth noting the rounded ends (5) and (6) that define the border between the base and the front face of the upper and lower poles and that do not possess the implants of the previous technique, and that give it that peculiar and own form and the characteristics of universality that is applied for purposes of aesthetic improvement and for reconstructive purposes of the gluteal region, is placed preferably in the sub-facial, intramuscular or sub-muscular, in the different measurements and volumes at the patient's will .
The novel aspect of this universal implant, is the anatomical and exact form, only for the gluteal region in terms of its shape, volume, projection, appearance and consistency that are similar to the buttocks of normal people. Another novelty is that it has palpable marks in a semi-spherical shape on the flat surface and the convex surface of the front face, as well as the contour line (4) that forms the border and separates both surfaces, said palpation marks help ensure the correct position in the gluteal region. Silicone gel implants like the one in figure 2 a, are used in cases of gluteal augmentation where it is not necessary to increase muscle tone, their selection depends on the clinical determination of muscle tone. Solid silicone elastomer implants are used in cases where it is necessary to increase muscle tone, as described in figure 2b, where the top view of the implant in the form of half almond (26), the surface cover is shown textured (3), the maximum extension (A), the upper palpation points (1) and (2) of the front face; a transverse section of the almond-shaped implant is also shown (26), where the difference in inclination is perceived for both sides defined by the line of maximum projection where the three palpation points are located; but in this case the lower surface or base is concave to adapt to the shape of the cavity where it will be placed finally, in contrast to the flat surface (25) of the silicone gel, this implant is solid consistency of silicone elastomer (26), can be smooth or textured surface. However, although the material is solid. This implant also has the upper palpation points (1) and (2) of the convex surface, the palpation points of the base or lower (21) and (22) are in a longitudinal central line, as well as the probing contour line (4) of the solid silicone elastomer implant, the maximum length is indicated ( B), the maximum projection (C) and that in this case is less than those of silicone gel due to the concave shape of the adaptive base. Figure 3 shows the implant, object of the present invention, in position of use (30), the implant (10) is placed in its sub-muscular pocket in the gluteal cell space, under the intramuscular space of the gluteus maximus (31). ), both covered by the gluteus medius (33) and without danger of damaging the sciatic nerve (32). Particular embodiments of the invention have been illustrated and described, it will be obvious to those skilled in the art that various modifications or changes may be made without departing from the intended scope. The foregoing is intended to be covered by the appended claims so that all changes and modifications fall within the scope of the present invention.