Process and system for making customized scalp patches

Abstract

A customized manufacturing process for producing scalp patches for hair augmentation that are customized to the skull shape of at least one patient, the process comprising the following main steps: a) patient mapping, which involves collecting all information and mapping the patient by 3D scanning to create a digital copy (digital twin) of the patient, and creating a template structure by 3D printing; b) preparing the template for processing, which preferably involves applying high-density elastic polyurethane; and c) implanting hair by bringing it close to the template connected to a suction system, which draws the hair into special holes by suction, heating the polymer film to near its melting point to integrate the hair to achieve a natural hair state, and cooling.

Description

[Technical Field]

[0001] The present invention relates to the industry of making customized scalp patches. [Background technology]

[0002] The term "alopecia" refers to the process of deterioration of hair quality (color, thickness) and loss or reduction of hair volume.

[0003] The most common is male pattern baldness, characterized by a receding hairline on both sides of the forehead and on the top of the head. As hair loss progresses, these two areas join together, leaving only a band of hair at the back of the head. In Italy, 39.01% of men have hair loss problems, and the rate increases with age.

[0004] And hair loss isn't just a problem for men: female pattern hair loss is much more prevalent today than it used to be, affecting 4 million women in Italy, or about 13% of the female population (statistics from the Helvetico Sanders Institute Tricological Center, which has been working in this field for over 30 years).

[0005] The psychological and social burden of alopecia is much greater for women than for men. Women who lose a lot of hair tend to be reluctant to cut their hair short, making it difficult to hide thinning hair.

[0006] Wigs and hair transplants have been used to address hair loss. However, hair transplants require actual surgery and typically take several months to produce results. For example, U.S. Patent No. 5,782,851 discloses a system for harvesting hair tissue (hair grafts) from a donor region of a patient's scalp and transplanting them to a recipient region of the patient's scalp. This system involves harvesting a specified number of skin fragments containing viable hair follicles from the donor region of the patient's scalp and cutting the harvested skin fragments into hair tissue fragments. The hair transplantation step involves implanting the hair tissue fragments one by one into the recipient region of the patient's scalp. Thus, this system is not only a time-consuming and invasive treatment, but also expensive.

[0007] Furthermore, traditional hair transplants involve transplanting hair from one area of ​​the patient's scalp to another area where thinning is most noticeable, and because the transplanted hair leaves a new, hairless area, it does not increase the overall amount of hair.

[0008] A scalp patch consists of hair (natural or synthetic) attached to an extremely thin, invisible base (of various materials), which can be applied to bald areas of the scalp to faithfully recreate hair. Scalp patches have the advantage of not requiring any surgical procedures.

[0009] Scalp patches are the result of advancements, research and innovation in the field of hair loss solutions and can be thought of as the "modern" wig.

[0010] Wigs are typically used by users who have total hair loss or temporary hair loss due to, for example, chemotherapy. Scalp patches, on the other hand, are essentially a non-surgical method of hair augmentation used to cover parts of the scalp. For this reason, wigs are suitable for users who have completely lost their hair, while scalp patches are more suitable for users who are experiencing ongoing hair thinning and want to augment their hair.

[0011] There are two types of scalp patches available on the market: standard patches and patches that are customized to fit the customer's needs and skull shape.

[0012] The present invention relates to a second type of patch.

[0013] The first step in creating a customized scalp patch requires obtaining customer data, particularly data about the skull shape of the area where the scalp patch will be applied. This step is currently performed manually, by attaching gauze soaked in a hardening polymer material to the skull to create a mold of the customer's / patient's skull. This procedure not only uses a large amount of fibrous material (gauze), but also chemicals that require strict disposal management. The next steps in scalp patch creation are currently largely unmechanized. For example, the process of drilling tiny holes that mimic natural hair follicles and implanting hair into these holes are still performed manually. These methods have the disadvantage of being time-consuming.

[0014] In addition, conventional scalp patches have the drawback that the durability decreases over time because the hair is only injected and not knotted.

[0015] Therefore, the present patent application - faster and less invasive acquisition of customer / patient data (particularly data relating to the skull geometry of the scalp patch application site) without the use of disposable materials, followed by the creation of a customer / patient digital twin; - To produce scalp patches more quickly and efficiently, The object of the present invention is to provide a novel method and a novel system for realizing the above. Summary of the Invention

[0016] SUMMARY OF THE INVENTION In accordance with the present invention, a system and method for customizing and creating scalp patches is provided that effectively addresses the above-mentioned problems.

[0017] The method for customizing and creating a scalp patch can be divided into three main steps: patient mapping, working base preparation, and hair implantation, each of which can be further divided into several steps and substeps.

[0018] The first major step, patient mapping, can be divided into at least seven steps:

[0019] 1. Parameter acquisition: involves analyzing and defining the patient's scalp characteristics, such as hair typology, color, density, and aesthetic characteristics, followed by identifying the affected skull area that needs to be covered with a scalp patch. This step is crucial as it allows for the acquisition of a scalp patch configuration tailored to a specific patient.

[0020] 2. To obtain a better image of the patient's skull, a transparent film is applied to the patient's head, and the area relevant for detection is then demarcated by the operator using a special kajal pencil.

[0021] 3. Automatic skull shape detection using a structured light 3D scanner. This procedure maximizes patient dignity and eliminates the need for cellophane film, hardening resins, or tools for pasting and applying them, making it environmentally sustainable and simplifying the operator's work. A structured light 3D scanner is a system that digitizes the three-dimensional shape of an object and reconstructs the object's shape by projecting coded light patterns. Because each individual's skull is unique, accurate skull shape detection is essential for optimal results and a perfectly fitting scalp patch. 3D scanning using structured light enables scalp detection and color mapping, commonly known as texture. Color differences are useful for identifying affected areas. Because structured light is safe and harmless to the human body, structured light 3D scanners are also used for medical human body scanning. This step of detecting the patient's skull shape is automated using a structured-light 3D scanner, significantly speeding up the process compared to the current method, which is done manually using gauze soaked in a curable polymer material. In addition to saving time, this process has two additional advantages: it reduces stress for the patient by not applying chemical products to the skin, and it reduces the environmental impact of the entire process by not using textile materials or chemicals that require controlled disposal.

[0022] 4. Creation of a CAD model of the "working head": Starting from the raw detection data, a parametric 3D model (CAD) is created that perfectly reflects the patient's affected area through analysis and correction using specialized software. Creating a digital copy (digital twin) of the patient allows for increased accuracy and reproducibility during each procedure. The "working head" is a physical 3D model that accurately reproduces the patient's skull shape. The working head includes a skull surface that matches the acquired model and a connection base, with a suction system located below the skull surface. The connection base consists of a cylindrical profile with a thread, preferably a fine-pitch Whitworth type. Since this thread will be used to connect pipes under gas pressure in a subsequent work step, it is important to select a very fine-pitch thread. A very fine pitch allows for a very strong connection due to the proximity of adjacent threads. When combined with a gasket, it can withstand high pressures. This configuration of the working head is advantageous because it can withstand suction pressure (suction of hair, which will be explained in the next step). The main feature of the working head is that the pores of the follicular matrix located on the skull surface are connected to the connection base by an internal cavity. This internal space allows for suction and insertion of hair, as will be explained in the next step.

[0023] 5. Processing of the hair follicle matrix: Once the modeling of the working head is complete, the operator processes the hair follicle matrix, which is composed of special conical holes representing the distribution of the patient's hair follicles, according to the data acquired in the parameter collection step. These holes have a conical shape suitable for receiving and holding the hairs to be implanted in the following step, and have the function of sucking and holding the hairs through connection to the suction system connected to the connection base prepared earlier.

[0024] 6. Preparation of template by 3D printing using SLA technology (Stereolithography).

[0025] 7. Robotic micro-drilling of the follicular matrix representing the distribution of hair follicles: Robotic micro-drilling involves the automated creation of a number of conical holes corresponding to previously identified points in the follicular matrix, using a suitable electrically controlled articulated robot arm. More precisely, to carry out micro-drilling, it is necessary to use a numerically controlled machine capable of machining semi-finished products with curved surfaces after the operation is completed. Machining of curved surfaces using a numerically controlled machine can be carried out by using a special contact probe that is able to detect the profile of the area to be drilled.

[0026] More precisely, this process is carried out as follows: - Mounting the template in a suitable housing inside the numerically controlled machine. -Detecting the profile by contact probe. - Micro drilling is performed using a conical cutter.

[0027] This innovative process allows for highly accurate micro-drilling on irregular surfaces.

[0028] The second major step is the preparation of the working base. First, preparing the template for processing involves applying a polymer film to the upper outer surface of the template, in the area representing the skull surface and the hair follicle matrix. The best material for this application has been found to be compact elastic polyurethane. Subsequently, the template is connected to the suction system by simply rotating it via an appropriate threaded section.

[0029] The third major step involves the implantation of the hair and is divided into the following sub-steps: At the workstation, the operator separates the hair into bundles of 5 mm to 50 mm, preferably 20 mm, and aligns the roots of each bundle. The operator then activates the suction system and begins the insertion process. When the suction system is activated, the hair is drawn close to the suction holes. By simply moving the hair past the template, the hair is drawn inside the conical holes and inserted in the correct manner. Once all the hairs have been sucked in and all the holes in the template are filled, the heating system is activated, raising the temperature of the polyurethane to near its melting point. When heated, the polymer film fills the gaps around the holes, causing the hairs to adhere to the film. When the heating system is turned off, it is allowed to gradually cool, which allows the polyurethane to solidify, resulting in a scalp patch that can be applied to a patient using known techniques.

[0030] This step is also automated using an aspiration process, making it faster and less burdensome for the operator.

[0031] The advantages of the present invention will be apparent from the above description and will become even more apparent from the accompanying drawings and the associated detailed description. [Brief explanation of the drawings]

[0032] The invention will now be described by way of non-limiting example only, with reference to the accompanying drawings, in which at least one preferred embodiment is shown.

[0033] [Figure 1] Figure 1 is a flowchart of the manufacturing method for customized scalp patches, showing three main steps: A. Patient mapping, B. Working base preparation, and C. Hair implantation, as well as seven sub-steps A1-A7 of the first main step. [Figure 2]Figure 2 shows the working head 1, which consists of a connection base 2 and a template 3 placed on top, with polyurethane 9 attached to the upper side of the template and a suction system 4 on the lower side that draws hair 7 into the micropores 6 that make up the hair follicle matrix 5. [Figure 3] FIG. 3 shows a scalp patch 8 having a hair follicular matrix 5 and hairs 7. [Figure 4] FIG. 4 is an enlarged view of the hair follicle matrix 5, showing the state in which a hair 7 is fixed inside the conical pores 6. DETAILED DESCRIPTION OF THE INVENTION

[0034] The present invention will now be described by way of non-limiting example with reference to the drawings which show some embodiments relating to the inventive concept.

[0035] Referring to FIG. 1, the method for creating a customized scalp patch 8 can be divided into three main steps: patient mapping, working base preparation, and hair 7 placement.

[0036] A) Patient Mapping: This step aims to collect / obtain all useful information and map the patient in order to generate a digital copy of the patient. This digital copy of the patient can be used in all steps of the scalp patch 8 creation. The digital twin is a virtual replica that integrates the patient's skull shape and features useful for processing. This process allows the patient's skull shape and features to be analyzed minimally invasively using digital tools, without the need for materials or techniques that apply invasive mechanical procedures to the patient's skin. This work is carried out in stages through parameter collection, preliminary hair shaving, and a 3D scan of the skull shape.

[0037] The first major step, patient mapping, can be further divided into seven steps:

[0038] a1) Obtaining parameters about the patient's scalp characteristics, e.g., hair 7 type, color, density, aesthetic properties, and identifying the affected area of ​​the patient's skull that needs to be covered with a scalp patch 8. This step is very important as it obtains the customized scalp patch 8 settings.

[0039] a2) In order to better capture the patient's skull shape during detection using 3D scanning, a transparent film is attached to the patient's head, and then the operator delineates the affected area identified by the detection using a special cartilage pencil.

[0040] a3) Automatic skull shape detection using a structured light 3D scanner: Since each individual's skull is unique, accurate skull shape detection is essential for optimal results and a perfectly fitting scalp patch. A handheld scanner, which can be held in one hand, is connected to a special PC and pointed at the patient's head. In this state, a light beam is emitted from the emitter, and changes in the beam are detected to analyze the surface of the affected area. The entire process is estimated to take 5 minutes in total.

[0041] a4) Using special software, a CAD model of the working head 1 is constructed that perfectly reflects the patient's affected area, thereby creating a digital copy (digital twin) of the patient and improving the accuracy and reproducibility of the work.

[0042] a5) Based on the previously obtained parameters, a hair follicle matrix 5 is prepared, consisting of special conical holes 6 that represent the distribution of the patient's hair follicles. These holes 6 have a conical shape that allows them to receive and penetrate the hairs 7 that will be placed in a later step, and have the function of holding the hairs 7 through connection to a suction system 4 that is connected to the base of the prepared working head 1.

[0043] a6) The template 3 is prepared by 3D printing using SLA technology (stereolithography). More precisely, SLA 3D printers use photoreactive resins. When the stereolithography resin is exposed to light of a specific wavelength, short molecular chains bond together, and the monomers and oligomers polymerize and solidify, forming a hard or soft geometric object. Thus, a file containing the 3D model is transferred to the printer, which then produces the template 3 made of the appropriate photosensitive resin.

[0044] a7) Micro-drilling holes 6 in the hair follicle matrix 5, representing the distribution of hair follicles, using a robot. Holes 6 with a starting diameter of preferably 1 mm and a lower diameter of preferably 0.5 mm are formed using a suitable electronically controlled articulated robot arm. More precisely, micro-drilling requires the use of a numerically controlled machine suitable for machining semi-finished products with curved surfaces. Machining curved surfaces using a numerically controlled machine can be performed using a special contact probe capable of detecting the shape of the area to be drilled. Specifically, the template 3 is first mounted in a suitable housing inside the numerically controlled machine, the shape is detected using the contact probe, and micro-drilling begins using a conical cutter.

[0045] b) Preparation of the Working Base: Preparing the template 3 for processing involves applying a polymer film to the upper outer surface of the template, i.e., the area representing the skull surface and the hair follicle matrix 5, followed by connecting the template to the suction system 4 by simply rotating it via a suitable thread. The polymer film is known to have three characteristics: high mechanical resistance, preferably 0.3 to 0.8 mm thick; high elasticity and flexibility for optimal adhesion to the scalp; and transparency for the most natural aesthetic effect. High-density elastic polyurethane has been found to be the optimal material for this application. Polyurethane can be applied / applied by automatic or manual spraying. To prevent clogging of the micropores 6, a special compressor is connected to the template 3 to push air through the micropores 6 and remove any residue. The template 3 is then connected to the suction system 4 by simply rotating it via a suitable thread. The equipment required to suction the hairs 7 through the micropores of the template 3 can be described as follows: That is, the template 3 is firmly installed and connected to a suitable work table by a suitable fixture having a cylindrical portion with a Whitworth screw (the dimensions of the work table are preferably about 1000 mm x 2000 mm), and the template 3 is connected to a suitable heating system via an electric resistance and also to a suction pump 4, and the suction pump 4 is installed below the work table and is sized to obtain a given vacuum capacity under average conditions. Specifically, 3 Pa~1×10 -1 It is desirable to achieve a value of 0.05 Pa. The pump is equipped with an electromechanical actuator that switches it on and off. Between the pump and the template 3, a special barometer 11 is installed to monitor the pump pressure.

[0046] c) The hairs 7 are implanted by automatically or manually bringing them close to the template 3 connected to the suction system 4. First, an operator at a workstation divides the hairs 7 into bundles, each 0.5 to 50 mm long, preferably 20 mm long, and aligns the roots of the bundles. Next, the operator activates the suction system 4 and begins the insertion process. Once the suction system 4 is activated, the hairs 7 are brought close to the holes 6, either manually or by a suitable robot. Simply moving the hairs 7 past the template 3 draws them into the conical holes 6 and engages them in the appropriate shape. Once all hairs 7 have been suctioned and all holes 6 in the template 3 are filled, the heating system is activated to raise the temperature of the polyurethane to near its melting point. When heated, the polymer film fills the gaps around the holes 6, causing the hairs 7 to adhere to the film. The heating system is then turned off and the system is gradually cooled, allowing the polyurethane to solidify. The scalp patch 8 is now ready for application to the patient.

[0047] All the equipment used in each step of the method described above constitutes a system for making the scalp patch 8 that is the object of the present invention. The present invention is defined by the appended claims. Finally, it will be apparent to those skilled in the art that various modifications, additions and variations can be made to the invention described above without departing from the scope of the claims defined by the appended claims.

Claims

1. A customized manufacturing process for producing a scalp patch (8) for hair augmentation customized to the skull shape of at least one patient, the process comprising: a) a step of mapping the patient, the purpose of which is to collect / obtain all useful information and map the patient in order to generate a digital copy of the patient that can be used in all steps of making the scalp patch (8), with the sub-steps: a1) obtaining / collecting parameters about the patient, including analyzing and defining scalp characteristics including hair type, color, density, and aesthetic characteristics of the patient, and identifying affected areas of the skull that need to be covered with the scalp patch (8); a2) attaching a transparent film to the patient's head in order to better capture the shape of the patient's skull during detection using a 3D scan, and then demarcating the identified affected area by an operator using a dedicated cartilage pencil; a3) detecting the skull shape by 3D scanning of the skull with structured light; a4) based on the scan (a3), analyzing and processing a parametric 3D model (CAD) that fully reflects the affected area to generate a digital twin of the patient that allows accuracy and reproducibility in all work steps, and using dedicated software to design a working head (1) consisting of a physical 3D model that reproduces a skull surface (10) that matches the acquired model, wherein the working head (1) further comprises a connection base (2) in which a suction system (4) is arranged below the part of the connection base that reproduces the skull surface (10); a5) after the completion of the CAD model of the working head (1), processing a hair follicle matrix (5), which comprises a plurality of conical holes (6) representing the distribution of hair follicles of the patient according to the parameters obtained in the preceding sub-step (a1), a6) producing a mold or template (3) structure for replicating said scalp patch (8) by 3D printing using SLA (stereolithography) technology and mounting said template (3) in a dedicated housing inside a numerically controlled machine required for the curved machining of the semi-finished product after completion of the work, in order to carry out the robotic micro-drilling; a7) automatically creating the plurality of conical holes (6) corresponding to the identified points in the hair follicle matrix (5) by robotic micro-drilling using a conical milling cutter, said process further comprising: b) preparing the template (3) for further processing by applying a polymer film, preferably made of high density elastic polyurethane (9), 0.3 mm to 0.8 mm thick to the upper outer surface of the template in the area representing the skull surface (10) and the hair follicle matrix (5); b1) connecting said template (3) to a dedicated compressor that pushes air through said micropores (6) and removes any residues; c) connecting the template (3) to the suction system (4) by simply rotating it using a dedicated thread (12) adapted to engage with the connection base (2), and then implanting the hair (7) by manually or automatically bringing the hair (7) close to the template (3) connected to the suction system (4), c1) sucking the hair (7) into the interior of each of the conical holes (6); c2) heating the polymer film (9) to near its melting point to embed the hair (7) in the polymer film to achieve a desired natural hair state; c3) cooling the polymer film (9) back to room temperature.

2. 2. The customized manufacturing process for scalp patches (8) according to claim 1, characterized in that the robotic micro-drilling in sub-step (a7) is performed using a numerically controlled machine suitable for processing semi-finished products with curved surfaces after completion of the operation.

3. 1. A customized manufacturing system for producing scalp patches (8) for hair augmentation customized to the skull shape of at least one patient, said system being usable in a process according to claim 1 or 2, comprising: a structured light 3D scanner configured to detect the skull shape; and Dedicated software for post-processing the data acquired by the 3D scanner to improve the accuracy of the detected surface; A template (3) produced by 3D printing using SLA (stereolithography) technology to reproduce the shape of the scalp patch (8); a numerically controlled machine having a contact probe and configured to perform micro-drilling on said template (3); a working head (1) for reproducing the skull surface of the patient according to the model obtained by the 3D scan of substep (a3), the working head including a suction system (4) configured to suck hairs (7) into conical micropores (6) that reproduce the hair follicle matrix (5), and a heating system configured to fix the hairs (7) inside the conical micropores (6); a compressor for forcing air through the micro-holes (6) to remove any residue after a polymer film, preferably made of high density elastic polyurethane (9), has been applied to the template; a suction system (4) configured to suck hairs (7) inside said conical micro-pores (6).

4. 4. A customized manufacturing system for scalp patches (8) according to claim 3, characterized in that it comprises a connection base (2) constituting the working head (1), said connection base having a cylindrical profile provided with a threaded portion (12), preferably of the fine-pitch Whitworth type, and configured to ensure a stable connection of a duct subjected to gas pressure.

5. 5. A customized manufacturing system for a scalp patch (8) according to claim 3 or 4, characterized in that the working head (1) includes an internal space that interconnects the conical holes (6) of the hair follicle matrix (5) arranged on the skull surface (10) with the connection base (2), the internal space being used for suctioning and inserting the hair (7).

6. 6. A customized manufacturing system for scalp patches (8) according to any one of claims 3, 4 and 5, characterized in that the polymer film (9) used in preparation for processing / working the template (3) is made of high density elastic polyurethane (9).

7. 7. A customized manufacturing system for scalp patches (8) according to any one of claims 3 to 6, characterized in that it comprises a robot configured to bring the hair (7) close to the template (3) during operation of the suction system (4), thereby inserting the hair (7) into the conical hole (6).

8. The suction system (4) is 3 x 10 ３ Pa ~ 1 x 10 －１ A customized manufacturing system for scalp patches (8) according to any one of claims 3 to 7, characterized in that it is configured to achieve Pa.

9. A customized manufacturing system for scalp patches (8) according to any one of claims 3 to 8, characterized in that the suction system (4) includes a barometer (11) for measuring and controlling pressure.

Images