Self-adhesive epithesis of the areola-nipple complex

Abstract

A self-adhesive nipple-areola complex (NAC) epithesis, characterized in that it comprises: a body made of a biocompatible elastomer material with a substantially flat, circular shape comprising a nipple-areola complex protrusion made of the same biocompatible elastomer material; and a sheet made of a self-adhesive medical-grade elastomer material configured to adhere removably to a patient's breast by one of its faces.

Description

Self-adhesive epithesis of the areola-nipple complex TECHNICAL SECTOR This disclosure refers to the technical field of medical breast implants, and more specifically, to self-adhesive nipple-areola complex (NAC) implants, especially indicated for breast reconstruction in patients who have undergone a lumpectomy or mastectomy, and which are also reusable. BACKGROUND OF THE INVENTION Currently, it is estimated that breast cancer affects more than 130 women per 100,000 inhabitants. This means that the probability of developing breast cancer as a woman is 1 in 8. In many cases, women diagnosed with breast cancer face surgery that will partially or completely remove one or both breasts. Breast-conserving surgery, also called a lumpectomy or wide local excision, involves removing part of the breast affected by cancer, along with a small margin of the surrounding normal breast tissue. A mastectomy usually involves the complete removal of one or both breasts. In both cases, the surgeries that women diagnosed with breast cancer undergo may involve breast removal, which can range from small resections of breast tissue, potentially including the nipple-areola complex (NAC), to the entire breast, including the NAC. These surgeries involving the total or partial removal of one or both breasts, in addition to the obvious physical effects they cause, also have a significant psychological impact on the women who undergo this procedure, as they are left mutilated. Even if they partially retain their breasts, in many cases they are left deformed, scarred, and may lack a nipple-areola complex (NAC). To date, women affected by this type of surgical intervention have undergone subsequent full breast reconstruction surgeries, tailored in each case to the wishes and characteristics of each patient. The aim of breast reconstruction is to: recreate a breast with a normal appearance, including the areola and nipple; eliminate the need for external implants and padding; fill any voids and deformities that may remain in the chest; attempt to achieve the greatest possible symmetry with the opposite breast; and restore body image and improve the patient's quality of life. Currently, there are many breast reconstruction techniques, all of which must be applied by plastic surgeons in consultation with breast specialists, striving to personalize the treatment for each patient.For the vast majority of women with breast cancer, breast reconstruction improves their self-image, facilitates greater emotional stability, and allows them to cope with the disease in a more positive way and lead a more active social life. For surgical nipple reconstruction, there are two main techniques: taking a portion of the healthy nipple and implanting it as a graft in the breast to be reconstructed. This technique is only applicable to cases with sufficiently large nipples, and in addition to causing a scar on the healthy nipple, it can alter its sensitivity and be very painful. Alternatively, local flaps can be performed using skin from the same breast. This involves creating a pedicled "button" as a thin dermofat flap, which simulates the shape and dimensions of the contralateral nipple. This second technique is the most commonly used. Regarding surgical reconstruction of the areola, there are also two main techniques: tattooing the areola to match the color of the healthy areola. This is simple, quick, and minimally invasive, but it lacks a raised surface. Alternatively, a full-thickness skin graft can be performed using tissue from a more pigmented area of ​​the body than the breast, such as the inguinal fold. When taken from the fold, the scar is concealed, and the areola remains as a distinct and well-defined anatomical unit. However, these types of nipple-areola complex (NAC) reconstruction procedures present several drawbacks. First, they require one or more surgical interventions with the associated medical risks. Second, the visual result of the reconstructed NAC is never identical to that of the NAC in the opposite breast, so aesthetically, these procedures are rarely entirely satisfactory for patients. Additionally, some of these techniques involve the removal of other parts of the patient's body for use as grafts, with the resulting aesthetic and medical complications. Furthermore, it can take between one and one and a half years between a patient undergoing volumetric breast reconstruction and the NAC reconstruction surgery, meaning that during this time the patient will be without a complete breast. Therefore, it is essential in the current state of the art for epithelial caps of the anterior chamber (AC) that they be hyperrealistic, closely resembling the patient's AC before surgical removal, and that they be self-adhesive, eliminating the need for glues and the corresponding solvents for removal, thus improving hygiene in the area affected by the previous surgery. Furthermore, they are reusable and biocompatible with the patient's skin to prevent skin conditions resulting from their continued use. EXPLANATION OF THE INVENTION A first subject of this disclosure relates to a self-adhesive nipple-areola complex (NAC) epithesis. As defined herein, the term epithesis refers to a prosthesis placed on the external part of the human body to correct a physical defect. The self-adhesive epithesis comprises a body made of a biocompatible elastomer material, substantially flat and circular in shape, comprising a nipple-areola complex protrusion made of the same biocompatible elastomer material. The epithesis also comprises a sheet made of a self-adhesive medical-grade elastomer material, configured to adhere removably to the patient's breast.Both the biocompatible elastomer of the epithesis body and the self-adhesive medical-grade elastomer of the sheet, which is in direct contact with the patient's chest, possess a degree of elasticity that allows the epithesis to follow the body's movements, and more specifically, the patient's chest movements. As described here, the self-adhesive property of the medical-grade elastomer refers to the adhesive forces generated by the elastomer material itself, which cause it to adhere to the patient's skin without the need for adhesives, glues, or similar substances. Because the epithesis sheet is made of a self-adhesive elastomer material, it adheres to the patient's chest from the inside, removably, without the need for adhesives, glues, or similar substances. This solution is particularly convenient as it allows for the epithesis to be reused many times without applying chemicals to the skin that could cause rashes, redness, etc. In fact, this epithesis can be worn daily for several months by a patient. Furthermore, it also promotes hygiene in this area, which may present with lesions resulting from the surgical procedure the patient has undergone. The hyperrealistic characteristic that the protuberance can present means that both the nipple and areola of the epithesis perfectly imitate a real nipple and areola, both presenting the characteristic hollows, roughness, cracks, etc., that real nipples and areolas present. The self-adhesive nipple-areola complex (NAC) epithesis can be prefabricated from photographs of the patient's own NAC before undergoing a lumpectomy or mastectomy. Preferably, the self-adhesive epithesis can also be fabricated from a mold of the patient's NAC before surgical removal. For example, a patient undergoing a mastectomy can provide models of her own NACs using high-resolution photographs or silicone or alginate molds so that, during subsequent breast reconstruction, hyper-realistic self-adhesive epitheses can be fabricated. This would lead to greater patient acceptance of the epitheses by faithfully replicating their own NACs. Alternatively, it can be fabricated from photographs or molds of other women's nipple-areola complexes used as catalog models. The elastomer material from which the CAP epitheses are made is biocompatible, hypoallergenic, waterproof and UV resistant. In some embodiments, the biocompatible elastomer material from which the epithesis body is made is selected from a group comprising biocompatible polyurethane, biocompatible silicone, and a combination of both. In some embodiments, the medical-grade elastomer material from which the epithesis sheet, which is in direct contact with the patient's skin, is made is selected from a group comprising medical-grade polyurethane, medical-grade silicone, and a combination of both. Both the polyurethane and silicone from which the body and sheet of the epithesis can be made have an adequate degree of flexibility that adapts to the movements of the patient's chest. In some designs, the body includes pigments to color at least the nipple area and / or the areola area of ​​the protuberance, forming a nipple-areola complex. Preferably, these pigments can be mineral-based, such as acrylic ink, plant-based, or synthetic. Pigmenting the epithesis allows each epithesis to be adapted to the skin and nipple color of each patient, achieving greater hyperrealism. In some embodiments, the epithesis has a diameter of between 2 and 4.5 cm, preferably between 3.5 and 4.5 cm, and most preferably 4 cm. The epithesis could also have other dimensions to adapt to the particularities of the CAP that is intended to be replicated. In some implementations, the epithesis has a maximum height of 1 cm. However, the height of the epithesis will be adapted to the dimensions of the patient's CAP, and may be less or even more than 1 cm in height. In some embodiments, the body and the epithesis sheet form a single unit. That is, the body comprising the protrusion and the self-adhesive sheet are manufactured as a single piece. In some embodiments, the sheet is configured to adhere, on a side opposite the side that adheres to the patient's chest, to an inner surface of the body. The self-adhesive property of the medical-grade elastomer from which the sheet is made ensures that it adheres to the inner surface of the body. An adhesive could also be used to reinforce the adhesion between the body and the sheet. In some designs, the body has an internal cavity. This cavity lightens the weight of the epithesis to prevent it from detaching from the patient's skin. In some realizations, the epithesis body defines both the nipple and the areola of the areola-nipple complex. In some embodiments, the epithesis body comprises platinum particles. These platinum particles reduce the surface tension of the epithesis, minimizing curling. They also make its outer surface less rough and therefore smoother to the touch. A second object of this disclosure relates to a kit comprising a self-adhesive areola-nipple complex epithesis as described above and a polyethylene backing. The epithesis is configured to rest on the polyethylene backing by the side of the sheet that is designed to adhere to the patient's breast. The polyethylene prevents this surface of the sheet from adhering to the polyethylene, thus ensuring the proper preservation of the epithesis. In some embodiments, the polyethylene backing has a mesh configuration. This mesh configuration, with gaps, reduces the contact surface between the inner face of the sheet and the polyethylene backing. In some versions, the kit includes a box that houses both the self-adhesive epithesis of the areola-nipple complex and the polyethylene support, for transport and marketing. The solution described here provides hyper-realistic, self-adhesive breast caps that look and feel natural, are biocompatible, hypoallergenic, waterproof, and UV-resistant. By eliminating the need for chemical adhesives, they are more hygienic than other state-of-the-art solutions and can be used as soon as the breast area where they are placed has healed, which generally occurs one month after volumetric breast reconstruction surgery. They are reusable for several months and allow women to non-invasively regain the appearance of their breasts before mastectomy, with the resulting psychological benefits. BRIEF DESCRIPTION OF THE DRAWINGS To complement the description being made and in order to help a better understanding of the characteristics of the invention, a set of drawings is included as an integral part of said description, in which, for illustrative and non-limiting purposes, the following has been represented: Figures 1A-1C.- Show various views of the self-adhesive hyperrealistic epithesis of the areola-nipple complex, according to a particular embodiment of the invention. Figures 2A-2C.- Show several views of the self-adhesive hyperrealistic epithesis of the areola-nipple complex, according to another particular embodiment of the invention. Figure 3.- Shows a front view of the two breasts of a woman with the self-adhesive hyperrealistic epitheses of the areola-nipple complex, according to a particular embodiment of the invention. DETAILED DESCRIPTION OF THE DRAWINGS Figure 1 shows several views of the self-adhesive hyperrealistic epithesis of the areola-nipple complex 100, according to a particular embodiment of the invention. Specifically, Figure 1A shows a front view of epithesis 100, Figure 1B shows a front and perspective view of said epithesis 100, and Figure 1C shows a side view of the same epithesis 100. As shown in Figure 1, the hyperrealistic, self-adhesive epithesis of CAP 100 comprises a biocompatible silicone body with a substantially flat, circular shape. On the front face of the medical-grade silicone body 101, a hyperrealistic protrusion defines the areola 101 and nipple 102, both made of the same biocompatible silicone. The body could also be made of other biocompatible elastomeric materials. The protrusion exhibits the same cracks, hollows, wrinkles, mounds, etc., as the areola and nipple used as models. This protrusion may have an internal cavity to reduce the weight of the epithesis 100. The areola and nipple used as models could be those of the patient who will subsequently use the epithesis, or they could be models of another person's areola and nipple previously stored in a database or catalog of models.The epithesis 100 is designed to adhere, without the use of an adhesive, by means of its inner surface 103, which is made of self-adhesive medical-grade silicone, to a patient's breast in a removable manner. The self-adhesive property of the epithesis 100 allows the patient to remove it to shower, for example, and replace it once the breast area is clean and dry. This epithesis 100 can be reused a large number of times before needing to be replaced. For example, it could be used daily for several months. This inner surface 103 of the biocompatible silicone body, not shown in the figures and corresponding to the inner surface of the sheet made of self-adhesive medical-grade silicone, has a substantially flat surface and may have a slight concavity to adapt to the shape of the patient's breast to which it will adhere.In this embodiment, the body and the self-adhesive sheet are manufactured as a single unit, i.e., they form a single piece. Figure 1 also shows greater pigmentation in the nipple area 102 and less pronounced pigmentation in the areola area 101. The pigment used to color both the nipple area 102 and the areola area 101 could be an acrylic pigment or another type. The combination of the realistic shape of the epithesis body protrusion with the coloration of epithesis 100 makes it closely resemble real CAPs. Epithesis 100 may have platinum particles embedded in the protrusion to reduce surface tension and adhesion, thereby minimizing epithesis curling. Figure 2 shows several views of the self-adhesive hyperrealistic epithesis of the areola-nipple complex 200, according to another particular embodiment of the invention. Specifically, Figure 2A shows a front view of epithesis 200, Figure 2B shows a front and perspective view of said epithesis 200, and Figure 2C shows a side view thereof. Epithesis 200 in Figure 2, unlike epithesis 100 in Figure 1, exhibits greater pigmentation and roughness in the areola 201 and nipple 202 areas. Otherwise, epithesis 200 in Figure 2 has the same characteristics as epithesis 100 in Figure 1, including the self-adherence of the inner surface 203 of epithesis 200. Figure 3 shows a frontal view of a woman's two breasts 300 with self-adhesive hyperrealistic nipple-areola complex epitheses 301 attached to them. Figure 3 also shows the scars 302 on the patient's breasts 300 resulting from previous mastectomies and volumetric breast reconstruction surgeries. These epitheses 301 could have been manufactured from silicone or alginate molds of the patient's own nipple-areola complexes, obtained before the surgeries, or they could have been manufactured from silicone molds of the nipple-areola complexes of other women.Since the patient has surgical scars in the area where the epitheses 301 are placed, the fact that the aforementioned epitheses 301 do not use adhesives and only these areas 302 come into contact with the self-adhesive medical-grade elastomer material, reduces dirt in the area, minimizing the possibility of infection.

Claims

1. A self-adhesive nipple-areola complex (NAC) epithesis, characterized in that it comprises: a body made of a biocompatible elastomer material with a substantially flat, circular shape comprising a nipple-areola complex protrusion made of the same biocompatible elastomer material; and a sheet made of a self-adhesive medical-grade elastomer material configured to adhere removably to a patient's breast by one of its faces.

2. The epithesis according to claim 1, wherein the biocompatible elastomer material is selected from a group comprising biocompatible polyurethane, biocompatible silicone, and a combination thereof.

3. The epithesis according to claim 1 or 2, wherein the medical-grade elastomer material is selected from a group comprising medical-grade polyurethane, medical-grade silicone, and a combination thereof. 4.The epithesis according to any one of the preceding claims, wherein the body comprises pigments for coloring at least one area of ​​the nipple and one area of ​​the areola of the protuberance in the form of an areola-nipple complex.

5. The epithesis according to claim 4, wherein the pigments are pigments of vegetable origin, pigments of mineral origin, pigments of synthetic origin, or any combination thereof.

6. The epithesis according to any one of the preceding claims, wherein the epithesis has a diameter of between 2 and 4.5 cm, preferably between 3.5 and 4.5 cm, and more preferably 4 cm.

7. The epithesis according to any one of the preceding claims, wherein the epithesis has a maximum height of 1 cm.

8. The epithesis according to any one of the preceding claims, wherein the body and the sheet form a single unit. 9.The epithesis according to any one of claims 1 to 7, wherein the sheet is configured to adhere, on a face opposite the face by which it adheres to the patient's chest, to an inner face of the body.

10. The epithesis according to any one of the preceding claims, wherein the body has an inner cavity.

11. The epithesis according to any one of the preceding claims, wherein the body comprises platinum particles.

12. A kit comprising a self-adhesive epithesis of the areola-nipple complex as described in any one of claims 1 to 11 and a polyethylene support, wherein the epithesis is configured to rest on the polyethylene support by means of the face of the sheet that is configured to adhere to the patient's chest.

13. A kit according to claim 12, wherein the polyethylene support has a mesh configuration. 14.Kit according to claim 12 or 13, comprising a box housing the self-adhesive epithesis of the areola-nipple complex and the polyethylene support.