PROCESS AND SYSTEM FOR THE CUSTOMIZED PRODUCTION OF SKIN PATCHES

Abstract

Process for a customized production of skin patches, for realizing a customized patch according to a shape of the scalp of a patient for hair thickening purposes, comprising the following main steps: (a) patient mapping to collect all the information and map the patient to create a digital copy of the same (digital twin) by 3D scanning and production of the template structure by 3D printing; (b) setting of the template for machining consisting in the application preferably of the compact elastic polyurethane; (c) application of the hair by approaching the same to the template connected to the suction system: o suction of the hair inside special holes; o heating the polymeric film close to the melting point, incorporating the hair therein so as to obtain the desired natural hair effect; o cooling.

Claims

1. Process for a customized production of skin patches (8), for realizing a customized patch according to a shape of the scalp of at least a patient, for hair thickening purposes, characterized in that it comprises the following steps: a) mapping of the patient: the aim of this step being that of collecting/acquiring all useful information and mapping the patient in order to create a digital copy of the same, that may be used in all production steps of the skin patch (8), said first main step including the following sub-steps: a1) acquisition/collection of the patient's parameters, consisting in an analysis and definition of the patient scalp properties, like hair typology, color, density and aesthetic properties, and identification of the affected skull area that needs to be covered by said skin patch (8); a2) application of a transparent film on the patient head, in order to promote an improved acquisition of the skull shape during a detection using a 3D scanning, and subsequent delimitationby an operator who uses a dedicated kajal pencilof said area affected by said detection; a3) detection of the skull shape by means of a 3D scanning of the braincase and employing structured light; a4) analysis and processing of a parametric 3D model (CAD) based on the aforementioned scanning (a3), which reflects perfectly the affected patient area, and subsequent generation of a patient's digital twin allowing accuracy and repeatability of all operations, and creation by means of a dedicated software of the design of a work head (1) that consists in a physical three-dimensional model that reproduces the skull surface (10) and corresponds to the acquired model: wherein, said work head (1) also includes a connection base (2) with a suction system (4) arranged in a part located below the skull surface reproduction (10); a5) processing of a follicle matrix (5) after completion of the CAD modeling of the work head (1), said follicle matrix (5) consisting in a plurality of conical holes (6) representing the distribution of the patient's hair follicles in compliance with the parameters acquired during the preceding steps a) and c); a6) production of a structure for a template (3) or mold adapted for reproducing the skin patch (8), using 3D printing with SLA technology (stereolithography), and mounting of said template (3) on a dedicated housing within a numerical control machine needed for working on curved surfaces of accomplished/completed semi-finished products, for performing a robotized microperforation; a7) robotized microperforation using a conical milling cutter, consisting in an automated realization of said plurality of conical holes (6) which correspond to points identified previously with the follicle matrix (5); b) preparation of the template (3) for further working, consisting in the application of a polymeric film having a thickness of from 0.3 to 0.8 mm, preferably made of compact elastic polyurethane (9), on an upper outer surface of the template, that is, in an area representing the skull surface (10) and the follicle matrix (5); b1) connecting to said template (3) a dedicated compressor that will push air through the micro-holes (6) in order to clean them up from residual material, if any; c) connecting, by means of a pure rotation, the template (3) to a suction system (4) using a dedicated threaded portion (12) adapted to engage with said connection base (2), and applying subsequently said hair (7) by bringing them, either manually or automatically, close to said template (3) connected to the suction system (4): c1) sucking the hair (7) into the dedicated/corresponding conical holes (6); c2) heating up, so as to bring the polymeric film (9) close to the melting point, thereby embedding this hair (7) in it and obtaining the desired effect of natural hair; c3) cooling down, until the polymeric film (9) again attains room temperature.

2. Process for a customized production of skin patches (8), according to claim 1, characterized in that said robotized microperforation according to sub-step a7) occurs thanks to the use of a numerical control machine adapted for operating/acting on accomplished semi-finished products having curved surfaces.

3. System for a customized production of skin patches (8), for realizing a customized patch according to a shape of the scalp of at least a patient, for hair thickening purposes, characterized in that it is usable in a process according to claim 1, and in that it comprises at least the following elements: a structured-light 3D scanner, adapted for detecting the skull shape; a dedicated software used for the post-processing of the data acquired by means of the 3D scanner, for refining the acquired surfaces; a template (3) obtained through 3D printing with SLA technology (stereolithography) adapted to reproduce the shape of the skin patch (8); a numerical control machine provided with a contact probe, said machine being adapted to perform the microperforation of the template (3); a work head (1) that reproduces the patient's skull surface in accordance with the model acquired during the 3D scanning referred to in sub-step a3), including a suction system (4) adapted for sucking hair (7) into said conical micro-holes (6) which reproduce the follicle matrix (5), and also including a heating system adapted for fixing said hair (7) inside said conical micro-holes (6); a compressor that pushes air through said micro-holes (6) to clean them up from residual material, if any, following the application of the polymeric film, preferably of polyurethane (9), on said template (3); a suction system (4) for sucking hair (7) into the conical micro-holes (6).

4. System for a customized production of skin patches (8), according to claim 3, characterized in that for realizing the work head (1) the system comprises a connection base (2) formed of a cylindrical profile incorporating a thread (12), preferably of the Whitworth kind with a fine pitch, and adapted for ensuring a stable connection between ducts subjected to gaseous pressures.

5. System for a customized production of skin patches (8), according to claim 3, characterized in that said work head (1) comprises an inner cavity for an intercommunication between the connection base (2) and said conical holes (6) of the follicle matrix (5) arranged in the skull surface (10), said cavity being used in order to allow the insertion by suction of said hair (7).

6. System for a customized production of skin patches (8), according to claim 3, characterized in that the polymeric film (9) used for preparing the template (3) to the working/processing is realized from compact elastic polyurethane (9).

7. System for the production of skin patches (8), according to claim 3, characterized in that it comprises a robot adapted for approaching said hair (7) to the template (3) when said suction system (4) is operating, to allow inserting said hair into said conical holes (6).

8. System for the production of skin patches (8), according to claim 3, characterized in that said suction system is adapted to attain 3103 Pa1101 Pa.

9. System for the production of skin patches (8), according to claim 3, characterized in that said suction system comprises a barometer (11) for pressure evaluation and control.

Description

DESCRIPTION OF THE FIGURES

[0043] The invention will hereinafter be described in at least a preferred embodiment thereof by way of non-limiting example with the aid of the accompanying figures, in which:

[0044] FIG. 1 shows a flowchart illustrating the three main steps of the custom skin patch manufacturing method: mapping of patient A; preparation of the work base B; application of hair C and the seven sub-steps of the first main step of mapping of patient A1-A7;

[0045] FIG. 2 shows the work head 1 formed by the connection base 2 and at the top the template 3 on which the polyurethane 9 is applied, under which the suction system 4 is positioned which attracts the hair 7 inside the micro-holes 6 which make up the follicular matrix 5;

[0046] FIG. 3 shows the skin patch 8 with the follicular matrix 5 and the hair 7;

[0047] FIG. 4 shows an enlargement of the follicular matrix 5 composed of conical micro-holes 6 inside which the hair 7 is fixed.

DETAILED DESCRIPTION OF THE INVENTION

[0048] The present invention will now be described purely by way of non-limiting or binding example with the aid of the figures, which illustrate some embodiments relative to the present inventive concept.

[0049] With reference to FIG. 1, it describes a method for the customized production of skin patches 8 which can be divided into three main steps: mapping of the patient; preparation of the work base; hair application 7. [0050] a) Mapping of the patient: the aim of this step being that of collecting/acquiring all useful information and mapping the patient in order to create a digital copy of the same, that may be used in all production steps of the skin patch 8. The digital twin is nothing but the virtual replica of the patient's skull integrating shapes and features useful for the process. This process allows the conformation of the person's skull and its peculiarities to be analyzed with digital tools in a minimally invasive way and without the use of materials and techniques that involve invasive mechanical applications on the skin. The activity is carried out progressively through the collection of parameters, preliminary shaving and 3D scanning of the cranial conformation.

[0051] The first main step of patient mapping can be further divided into 7 steps: [0052] acquisition of the parameters of the patient scalp properties, such as: hair 7 typology, color, density and aesthetic properties, and consequent identification of the affected skull area that needs to be covered by the skin patch 8. This step is very important because it allows you to find a customized setting for the skin patch 8; [0053] a2) application of a transparent film on the patient head, in order to promote an improved acquisition of the skull shape during a detection using a 3D scanning, and subsequent delimitationby an operator who uses a dedicated kajal pencilof said area affected by said detection; [0054] a3) automatic detection of the cranial conformation using a structured light 3D scanner: a correct detection of the conformation of the skull is fundamental for the optimal result and a perfect adherence of the skin patch since the braincase varies from individual to individual. The handheld scanning device that can be gripped with one hand is connected to a special PC and is oriented towards the patient's head and, projecting lines of light through a special emitter, detects their variation by interpreting the affected surface. This process has a total duration that can be estimated at five minutes; [0055] a4) elaboration of a CAD model of the work head 1 through a special software which perfectly reflects the area of the patient involved. A digital copy (digital twin) of the patient is thus created which increases the accuracy and repeatability of the operations. [0056] a5) Processing of a follicular matrix 5 consisting of special conical holes 6 representing the distribution of the patient's hair follicles, in line with the previously acquired parameters. These holes 6 have a conical shape capable of receiving and containing the hair 7 which will be applied in a subsequent step and have the function of retaining the hair 7 through the connection to a suction system 4 connected to the base of the work head 1 previously prepared; [0057] a6) preparation of a template 3 through the production with 3D printing with SLA technology (Stereolithography). More precisely, SLA 3D printers use light-reactive resins. When stereolithography resins are exposed to light of a specific wavelength, short molecular chains join together, polymerizing the monomers and oligomers into solidified rigid or flexible geometries. Therefore, the file containing the 3D model is transferred to the printing device and the printer produces a template 3 through the solidification of a suitable photosensitive resin; [0058] a7) robotic micro-drilling of the matrix 5 of holes 6 representing the follicular distribution. By means of a suitable electronically controlled articulated robotic arm, the holes 6 are made with a starting diameter preferably of 1 mm and a lower diameter preferably of 0.5 mm. More precisely, for the implementation of the micro-drilling it will be necessary to use a numerical control machine adapted to operate on finished semi-finished products with curved surfaces. Machining of curved surfaces using numerical control machines is feasible by virtue of the use of a special contact probe capable of detecting the profile in which the drilling operation will then be carried out. More precisely, the operation will be carried out as follows: assembly of the template 3 on the suitable housing inside the numerically controlled machine; profile detection by contact probe; start of the micro-drilling process using a conical cutter. [0059] b) Preparation of the work base: setting of the template 3 for processing consisting in the application of a polymeric film on the upper external surface of the same, i.e. in the area representing the cranial surface and the follicular matrix 5, and subsequent connection to the aspiration system 4 via the appropriate threaded section with a simple rotation. Three features of the polymeric film have been identified: good mechanical resistance with a thickness preferably between 0.3 and 0.8 mm; good elasticity and flexibility for optimal adherence to the scalp; transparency for an aesthetic effect that is as natural as possible. The most suitable material for this application has been identified in compact elastic polyurethane. The application of the polyurethane takes place through automatic or manual spraying of the material. In order to avoid the clogging of the micro-holes 6, a special compressor will be connected to the template 3 which will push the air through the micro-holes 6 to clean them of any residual material. Subsequently, the template 3 is connected to the suction system 4 through the appropriate threaded section with a simple rotation. The device necessary for the suction 4 of the hair 7 through the micro-perforated template 3 can be described as follows: the template 3 is installed and connected firmly on a suitable work platform by means of a suitable fitting with Whitworth threaded cylinder (the work table will have preferably dimensions of about 1000 mm2000 mm); the template 3 is connected to the suitable heating system by means of an electric resistance and to the suction pump 4; below the platform there is a suction pump 4 specially sized to obtain a vacuum capacity in average conditions. Specifically, the values to be obtained will preferably be between 3103 Pa1101 Pa. The pump has an electromechanical actuator for switching it on and off. A special barometer 11 is installed between the pump and the template 3 which monitors the pump pressure. [0060] c) Hair application 7 takes place by manual or automatic approach of the same to the template 3 connected to the suction system 4. First, the hair 7 is divided by the operator into bundles of 05 mm to 50 mm, preferably 20 mm, each at the workstation and aligned at the base of the bundle. The operator can proceed with the activation of the suction system 4 to start the insertion. Once the suction system 4 has been activated, the hair 7 is brought near the holes 6 manually or by means of a suitable robot. With a simple passage of the hair 7 in the vicinity of the template 3, the conical holes 6 present receive the hair 7 inside them, engaging them in their appropriate profile. Once the aspiration of all the hairs 7 has been completed and all the holes 6 of the template 3 have been filled, the heating system is activated which brings the temperature of the polyurethane close to the melting point. The polymeric film, once heated, allows the adhesion of the hair 7 to it by filling the gaps near the holes 6. The system is progressively cooled by turning off the heating system to allow the polyurethane to solidify. The skin patch 8 is now ready for application to the patient.

[0061] All the instrumentation used in the steps of the method just described constitutes the system for making skin patches 8, object of the present invention.

[0062] The invention is defined by the appended claims.

[0063] Finally, it is clear that modifications, additions or variants may be made to the invention described thus far which are apparent to those skilled in the art, without departing from the scope of protection that is provided by the appended claims.