Method for manufacturing external silicone prostheses for the areola and nipple, and prosthesis obtained using said method

Abstract

The present invention relates to a method for manufacturing external silicone prostheses for the areola and nipple and to the prosthesis obtained using said method. The method comprises: a step (A) of preparing the silicone negative mould (m); a step (B) of applying a first layer (i) of pigmented silicone with details of the areola (2) and nipple (3); a step (C) of filling the nipple with a second layer (ii) of pigmented silicone matching the shade of the nipple (3) and additives and fibres; a step (D) of delimiting, measuring and filling the areola (2) with a third layer (iii) of pigmented silicone; a step (E) of catalysing the areola; a step (F) of applying a fourth layer (iv) of transparent silicone; a step (G) of removing silicone and creating the hollow (4) in the rear face (1b); a final catalysis step (H); and a step (I) of demoulding and cutting around the outer edge (5), leaving a protruding outer edge area (6).

Description

[0001] MANUFACTURING PROCESS FOR EXTERNAL SILICONE PROSTHESES FOR AREOLA AND NIPPLE, AND PROSTHESES OBTAINED WITH SAID PROCESS

[0002] DESCRIPTION

[0003] OBJECT OF THE INVENTION

[0004] The invention, as stated in the present descriptive memorandum, refers to a manufacturing process for external silicone prostheses for the areola and nipple and to a prosthesis obtained with said process, providing, to the function for which it is intended, advantages and characteristics, which are described in detail below.

[0005] More specifically, the object of the invention focuses on a manufacturing process for obtaining external prostheses for the reconstruction of the areola and nipple, which, being of the type that is carried out in a handcrafted manner using molds and platinum silicones pigmented in different phases to achieve a realistic and high-quality finish, is distinguished essentially by the fact that it contemplates an innovative method of encapsulated pigmentation, where the color is integrated within internal layers of the silicone material itself, instead of being applied externally on the surface of the same as is usually the case until now, ensuring that the pigment is not exposed to direct contact or wear, so that the prosthesis is much more durable while always maintaining its realistic appearance and color.

[0006] FIELD OF APPLICATION OF THE INVENTION

[0007] The field of application of the present invention falls within the sector of the industry dedicated to the manufacture of body prostheses, focusing particularly on the field of silicone prostheses, and more specifically on areola and nipple prostheses.

[0008] BACKGROUND OF THE INVENTION

[0009] Prostheses made of materials like platinum silicone are well-known on the market for reconstructing and replacing anatomical parts of the human body, particularly the areola and nipple. However, these types of prostheses are pigmented with specific paints and products applied to the surface of the silicone piece, which means they deteriorate quickly and lose their color due to friction and washing.

[0010] The objective of the present invention is to avoid this problem by developing an improved manufacturing procedure for this type of prosthesis where the pigmentation is integrated within the material itself, preventing it from being removed regardless of the activity of the wearer.

[0011] Furthermore, and with reference to the current state of the art, it should be noted that, at least as far as the applicant is concerned, there is no other procedure that presents technical and structural characteristics equal or similar to those claimed herein.

[0012] EXPLANATION OF THE INVENTION

[0013] The manufacturing process for external silicone areola and nipple prostheses and the prosthesis obtained with said process proposed by the invention represent an ideal solution to the problem described while also being an improvement over what is already known, with the characterizing details that make it possible and that distinguish them being conveniently included in the final claims that accompany this description.

[0014] What the invention proposes, as previously mentioned, is a manufacturing process for external platinum silicone prostheses of the type that is made by hand, using molds and silicones, with the particularity that these color pigments are integrated within internal layers of the silicone material itself in different phases, instead of being applied externally on the surface of the same, achieving a prosthesis with a totally realistic finish, high quality and great resistance and durability.

[0015] More specifically, this process comprises the following stages:

[0016] - Mold Preparation:

[0017] The process begins with the use of a negative relief silicone mold that replicates a breast and nipple. This mold is a detailed replica that allows for the precise application of different layers of pigmented platinum silicone to mimic the texture, color, and shape of a realistic areola and nipple. - Application of pigmented platinum silicone for areola and nipple details:

[0018] Using platinum silicone that has been specially pigmented for this purpose, the details of the areola and nipple are drawn by hand directly onto the mold. This initial application provides the tonal and hue characteristics that define the prosthesis's natural appearance. Once applied, this layer is left to cure until it reaches the appropriate consistency.

[0019] - Filling of the nipple cavity:

[0020] After the initial curing phase, the nipple area of ​​the mold is filled with platinum silicone that has been pre-pigmented in the appropriate shade and enriched with the necessary additives and fibers to achieve the required texture. This application adds volume and realism to the prosthesis. The silicone is then left to cure completely in the nipple area.

[0021] - Delimitation, measurement and filling of the areola:

[0022] Next, the perimeter of the areola is measured and manually marked on the mold, also using pigmented silicone in the appropriate color. Once the area is defined, the areola is filled with this pigmented silicone. This step ensures the precise definition and realism of the areola in the prosthesis.

[0023] - Areola catalysis:

[0024] The silicone applied to the areola area is left to catalyze for a few minutes, until it acquires the optimal consistency for the next coating phase.

[0025] - Application of a transparent silicone layer:

[0026] Finally, a uniform pour of clear, pigment-free platinum silicone is applied, covering all the areas previously worked on the mold and encapsulating the color of each one. This transparent layer acts as the final coating of the prosthesis, providing a natural appearance and a homogeneous texture to the touch.

[0027] - Removal of excess silicone:

[0028] All the platinum silicone from the final stage is deposited in the center of the prosthesis, and a specific silicone brush is used to remove any excess from the center of the mold. This stage is crucial for the fine finish of the prosthesis and to ensure a suction effect that will result in a very strong bond to the skin without the need for adhesives.

[0029] - Final catalysis:

[0030] The fully formed prosthesis is left to cure for approximately 90 minutes. During this time, all the silicone layers reach the necessary hardness and consistency for handling and final use.

[0031] - Demolding and cutting:

[0032] Once the curing process is complete, the prosthesis is carefully removed from the mold. It is then placed on a surface previously coated with petroleum jelly for better control, and a manual cut is made using an oval mold, applying pressure and twisting to achieve the final contour.

[0033] With all this, the silicone prosthesis obtained through the described process represents a significant advance in terms of durability, realism, and resistance to degradation of appearance. The most outstanding innovative aspect of the resulting prosthesis is its exclusive encapsulated pigmentation method, which makes it a unique and superior product within its category.

[0034] The prosthesis pigmentation process involves integrating the color within internal silicone layers, encapsulating and protecting the pigment at the core of the prosthesis. Unlike other methods where the color is applied to the external surface, the pigment encapsulation process described in this invention ensures that the pigment is not exposed to direct contact or wear caused by daily use, cleaning, or friction with clothing. This distinguishing feature is key to preventing discoloration or deterioration that could affect both the visual realism and the overall appearance of the prosthesis.

[0035] Thanks to this internal pigmentation process, the prosthesis maintains its original color and details for an extended period, preventing any changes in tone or loss of definition that commonly occur in other similar products. Furthermore, the encapsulation of the pigment provides a more natural appearance, as the color seems to originate from within the material, allowing for a more accurate simulation of the color and texture variations inherent in human skin, particularly in the areola and nipple area. This pigment encapsulation, combined with the high quality of the silicone materials used and the high-density pigments, ensures that the resulting prosthesis not only fulfills an aesthetic function but also offers a durable and low-maintenance solution.

[0036] This focus on encapsulation provides an ideal product for those seeking a durable and long-lasting prosthesis that retains its original appearance even after constant use.

[0037] The innovative encapsulated pigmentation process represents a technical advance in the manufacture of silicone prostheses, providing a high-quality aesthetic solution with durability and visual realism.

[0038] In short, the manufacturing process described in the present invention for obtaining silicone areola and nipple prostheses is a highly detailed and controlled artisanal method that yields products with a high degree of realism and adaptability. The process guarantees a superior quality prosthesis, suitable for both aesthetic and reconstructive use, and ensures long-lasting durability thanks to its unique method of internal encapsulation of the color pigments, offering a reliable and advanced alternative for personalized aesthetic applications. Specifically, the manufacturing process for areola and nipple prostheses of the invention is innovative due to its encapsulated pigmentation, which allows the color to be integrated within the internal layers of the silicone, rather than being applied to the external surface as is common in other methods.This ensures that the pigment is completely protected from contact and wear, thus maintaining the realistic appearance and color of the prosthesis for a long time.

[0039] The morphological configuration of the prosthesis obtained through this process, specifically thanks to the central hollow in the back and the transparent layer that extends around the areola, ensures exceptional adherence to the skin without the need for external adhesives. Thanks to its optimized texture and shape, the prosthesis adheres effectively and naturally, providing a comfortable, secure, and practical fit for the user. This innovative adherence not only facilitates daily use but also contributes to a more natural and satisfying aesthetic experience. Furthermore, the prosthesis obtained through this manufacturing process is resistant to water, sweat, vigorous movement, and other elements, offering continuous comfort. With its simple application and, as mentioned, the absence of daily adhesives, it provides a long-lasting aesthetic solution for reliable and 100% realistic breast reconstruction.However, if extra fixation is needed, it is compatible with various medical-grade adhesives, although daily use is not necessary given its aerodynamics.

[0040] In any case, the combination of both innovations makes the resulting silicone prosthesis highly durable, visually realistic, and exceptionally comfortable for the user.

[0041] DESCRIPTION OF THE DRAWINGS

[0042] To complement the description being made and in order to help a better understanding of the characteristics of the invention, this descriptive document is accompanied, as an integral part thereof, by a set of drawings in which the following has been represented for illustrative and non-limiting purposes:

[0043] Figure 1 shows, in a block diagram, the representation of the different stages involved in the manufacturing process of external silicone prostheses for the areola and nipple, the subject of the invention.

[0044] Figure 2 shows a schematic cross-sectional and exploded view of the different layers of silicone that are applied to the mold, according to the process of the invention, to manufacture the prosthesis.

[0045] Figure number 3.- Shows a front view of an example of the implementation of the silicone areola and nipple prosthesis obtained by the process of the invention, which is represented with a portion of it raised, allowing a better appreciation of its configuration, especially of the transparent perimeter rim.

[0046] Figure 4 shows a top side perspective view of the prosthesis shown in Figure 2, highlighting the texture of the nipple. Figure 5 shows a bottom side perspective view of the prosthesis shown in Figures 2 and 3, highlighting the hollow configuration of the back of the prosthesis, which serves to fix it in place by suction.

[0047] PREFERRED EMBODIMENT OF THE INVENTION

[0048] In view of the aforementioned figures, and in accordance with the numbering adopted, one can observe in them, in addition to the steps of the process, an example of a non-limiting embodiment of the prosthesis obtained with the process of the invention, comprising what is indicated and described in detail below.

[0049] Thus, according to the diagram in Figure 1 and the schematic in Figure 2, the manufacturing process of external silicone prostheses (1) for the areola (2) and nipple (3) that are the subject of the invention comprises the following stages:

[0050] - A mold preparation stage (A), where a negative relief silicone mold (m) is prepared that reproduces a breast and nipple.

[0051] - A stage (B) of applying pigmented platinum silicone for details of the areola (2) and nipple (3), where, a first layer (i) of platinum silicone is applied which has been previously pigmented with the color of the areola in which, directly once incorporated into the mold, the details of the areola (2) and nipple (3) of the prosthesis (1) are drawn manually, and subsequently this layer is allowed to catalyze until it reaches the appropriate consistency to be able to apply the next layer.

[0052] - A stage (C) of filling the nipple cavity, where, after the catalysis of the layer (i) of the previous stage (B), the area of ​​the mold intended for the nipple (3) is filled with a second layer (i) of platinum silicone which in turn has been previously pigmented in this case with the tone corresponding to the nipple (3), as well as additives and fibers that determine the aesthetic roughness characteristics of the nipple (3), allowing said material to catalyze until its complete hardening in the nipple area (3).

[0053] - A stage (D) of delimiting, measuring, and filling the areola (2), where the perimeter of the areola (2) is manually measured and marked on the mold, and then, using pigmented silicone in the appropriate color, a third layer (i¡¡) of said pigmented silicone is applied to the delimited area. - A stage (E) of catalyzing the areola, where the silicone layer applied to the areola area (ill) in the previous stage (D) is left to catalyze for several minutes, until it acquires the optimal consistency for the next coating stage.

[0054] - A stage (F) of applying transparent silicone, where a uniform pouring of a fourth layer (iv) of platinum silicone is carried out, in this case transparent and without pigment, covering all the areas previously worked on the mold and encapsulating the color of each of them.

[0055] - A stage (G) of removing excess silicone, where, after depositing all the platinum silicone from the previous stage (F) in the center of the prosthesis (1), a specific silicone brush is used to remove the excess silicone material in the center of the mold and create a hollow (4) in the center of the back face (1 b) of the prosthesis (1) which serves to ensure a suction effect that allows a very high fixation of the prosthesis to the skin without the need to use adhesives for its fixation.

[0056] - A final catalysis stage (H), where the prosthesis (1), already fully formed within the mold, is left to catalyze for an approximate period of 90 minutes, in which all layers of silicone reach the hardness and consistency necessary for its handling and final use.

[0057] - And a demolding and cutting stage (I), where, once the catalysis process of the previous stage (H) is completed, the prosthesis (1) is carefully removed from the mold and, preferably, placed on a surface previously coated with petroleum jelly, for greater control, where a manual cut of the perimeter contour (5) is made, preferably using an oval mold, applying pressure and torsion, in any case, leaving a protruding perimeter area (6) in the transparent layer (iv).

[0058] For its part, taking into account figures 2 to 5, an example of the prosthesis (1) obtained is observed, which, having a configuration whose shape defines an approximately circular areola area (2) and a nipple (3) protruding on the external face (1a) or visible face, is distinguished, essentially, by consisting of a piece obtained by mold (m) that presents a suction hole (4) on the opposite or posterior (1 b) of the prosthesis (1), being composed of a set of various layers of silicone with pigmentation encapsulated in several of them, preferably comprising at least the following layers, listed in order from the outermost, on the external face (1a) or visible face of the prosthesis (1) to the one located on the opposite or posterior face (1 b):

[0059] - a first layer (i) of platinum silicone pigmented with the color tone of the areola and nipple, and with details drawn on the back of the same,

[0060] - a second layer (i) of platinum silicone pigmented with the tone corresponding to the nipple (3) and endowed with the roughness of the nipple (3),

[0061] - a third layer (iii) of pigmented silicone in the color tone of the areola (2), and

[0062] - a fourth layer (iv) of transparent platinum silicon.

[0063] In addition, preferably, the transparent silicone layer (iv) covers a protruding perimeter zone (6), around the layer (i¡¡) that defines the areola (2), as shown in the representation of figure 3, to provide a larger fixation surface, up to the perimeter contour (5) of the prosthesis (1 ).

[0064] Having sufficiently described the nature of the present invention, as well as the manner of putting it into practice, it is not considered necessary to make its explanation more extensive so that any expert in the field may understand its scope and the advantages that derive from it, it being noted that, within its essentiality, it may be put into practice in other forms of embodiment that differ in detail from the one indicated as an example, and which will also achieve the protection sought provided that its fundamental principle is not altered, changed or modified.

Claims

CLAIMS 1.- Manufacturing process for external silicone areola and nipple prostheses, characterized by comprising: - a mold preparation stage (A), where a negative relief silicone mold (m) is prepared that reproduces a breast and nipple; - a stage (B) of applying pigmented platinum silicone for details of the areola (2) and nipple (3), where a first layer (i) of platinum silicone is applied which has been previously pigmented with the color of the areola, on which, directly once incorporated into the mold, the details of the areola (2) and nipple (3) of the prosthesis (1) are manually drawn, and subsequently this layer is allowed to catalyze until it reaches the appropriate consistency to be able to apply the next layer; - a stage (C) of filling the nipple cavity, where, after the catalysis of the layer (i) of the previous stage (B), the area of ​​the mold intended for the nipple (3) is filled with a second layer (i) of platinum silicone which in turn has been previously pigmented in this case with the tone corresponding to the nipple (3), as well as with additives and fibers that determine the aesthetic roughness characteristics of the nipple (3), allowing said material to catalyze until its complete hardening in the area of ​​the nipple (3); - a stage (D) of delimiting, measuring and filling the areola (2), where the perimeter of the areola (2) is measured and marked manually on the mold and, after that, also using pigmented silicone in the appropriate color, the area of ​​the delimited area is filled with a third layer (i¡¡) of said pigmented silicone; - a stage (E) of areola catalysis, where the silicone layer applied over the areola area (i¡¡) in the previous stage (D) is allowed to catalyze for several minutes, until it acquires the optimal consistency for the next coating stage; - a stage (F) of applying transparent silicone, where a uniform pouring of a fourth layer (iv) of platinum silicone is carried out, in this case transparent and unpigmented silicone, covering all the areas previously worked on the mold and encapsulating the color of each of them; - a step (G) of removing excess silicone, where, after depositing all the platinum silicone from the previous step (F) in the center of the prosthesis (1), a specific silicone brush is used to remove the excess silicone material in the center of the mold and create a hollow (4) in the center of the back face (1 b) of the prosthesis (1) which serves to ensure a suction effect that allows a very high fixation of the prosthesis to the skin without the need to use adhesives for its fixation; - a final catalysis stage (H), where the prosthesis (1), now fully formed within the mold, is left to catalyze for a period of approximately 90 minutes, during which all layers of silicone reach the hardness and consistency necessary for handling and final use; and - a demolding and cutting stage (I), where, once the catalysis process of the previous stage (H) is completed, the prosthesis (1) is carefully removed from the mold and a manual cut of the contour (5) is made, leaving a protruding perimeter area (6) in the transparent layer (iv). 2.- Manufacturing process of external silicone prostheses for areola and nipple, according to claim 1, characterized in that, in the demolding and cutting stage (I), the prosthesis (1) is placed on a surface previously coated with petroleum jelly, and an oval mold is used to cut the perimeter contour (5) by applying pressure and torsion with said oval mold. 3.- Prosthesis, obtained by a manufacturing process as described in claims 1 or 2, having a configuration whose shape defines a circular areola area (2) and a protruding nipple (3) on the external face (1 a), is characterized by consisting of a piece obtained by mold (m) that has a suction hole (4) on the back (1 b) of the prosthesis (1 ), being composed of a set of various silicone layers with encapsulated pigmentation in several of them.

4. Prosthesis, according to claim 3, characterized in that said piece comprises, at least: - a first layer (i) of platinum silicone pigmented with the color tone of the areola and nipple, and with details drawn on the back of the same, -a second layer (i) of platinum silicone pigmented with the tone corresponding to the nipple (3) and endowed with the roughness of the nipple (3), -a third layer (i¡¡) of pigmented silicone in the color tone of the areola (2), and - a fourth layer (iv) of transparent platinum silicon. 5.- Prosthesis, according to claim 4, characterized in that the transparent silicone layer (iv) covers a protruding peripheral zone (6), around the layer (i¡¡) that defines the areola (2), up to the peripheral contour (5) of the prosthesis (1 ).

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