Method and system for custom production of skin patches

Abstract

A method for the custom production of a skin patch for the purpose of hair thickening according to the scalp shape of a patient, the method comprising the main steps of: a) drawing an image of the patient, collecting all information by 3D scanning and drawing an image of the patient to create a digital copy of the patient (digital replica), a template structure is generated through 3D printing; b) providing a template for processing, comprising the application of a preferred compact elastic polyurethane; c) applying the hair by approaching the hair to a template connected to a suction system: sucking the hair into the special hole; heating the polymer film to near the melting point, incorporating the hair therein to achieve the desired natural hair effect; and cooling.

Description

Technical Field

[0001] The present invention relates to the industrial field of custom-produced skin patches. Background Art

[0002] The term alopecia refers to the process of reduction or disappearance of hair quality (color, thickness) and quantity.

[0003] Male pattern baldness is certainly the most common and is characterized by receding hair, which affects the sides of the forehead and / or the top of the head; if hair loss continues, these two areas eventually join, leaving only a line of hair at the back of the head. In Italy, 39.01% of men have hair loss problems, and the percentage increases with age.

[0004] It's not just men who have problems with hair loss. Today, hair loss in women is more common than in the past, affecting 4 million women in Italy, or about 13% of the female population (statistics provided by the Helvetico Sanders Institute Trichoderma Center, which has been operating in this field for more than 30 years).

[0005] This problem brings many psychological and social inconveniences, much more than in the case of men: a woman with extensive hair loss is usually reluctant to cut her hair completely, and it is difficult to conceal hair loss.

[0006] To remedy hair loss, people resort to the use of wigs or hair transplants. Hair transplants consist of actual surgery, the results of which are usually shown after a few months. For example, US5782851A claims a system for transplanting hair grafts from a donor area of ​​a patient's scalp to a recipient area of ​​the patient's scalp. The system involves taking a specific number of skin strips containing live hair follicles from a donor area of ​​the patient's scalp, and then cutting the skin strips into hair grafts. Implantation involves implanting the hair grafts one at a time into the recipient area of ​​the patient's scalp. This system is particularly long and invasive, and is extremely expensive.

[0007] As an alternative, traditional autologous transplantation, which works by moving a patient's hair from one area of ​​the skin to the area most affected by hair loss, is unable to thicken because it moves some hair, leaving new hairless areas.

[0008] Skin patches consist of an ultra-thin and invisible substrate (of different materials) in which (natural or synthetic) hair is knotted, which is applied to the skin in hairless areas, faithfully simulating hair. Their advantage is that they do not require any type of surgical procedure.

[0009] Skin patches can be considered a “new” wig, the result of developments, research and innovations in the field of trichology involving solutions related to hair loss.

[0010] While wigs are often used by those who are completely bald or have temporary hair loss, such as those who are undergoing chemotherapy, skin patches, on the other hand, are essentially non-surgical hair thickening and coverage solutions for certain areas of the head. It is for this reason that it is more suitable for people who have thinning hair and want to thicken it, while wigs are more suitable for people whose hair has completely fallen out.

[0011] There are two types of commercially available skin patches: standard patches and custom patches based on the customer's needs and cranial anatomy.

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

[0013] In order to build customized skin patch, it is necessary to collect data on the client in the first step, particularly about the cranial structure of the area where the skin patch will be applied. At present, this step is manually operated by applying gauze soaked with hardened polymeric material on the head, and the gauze soaked with hardened polymeric material is used to build the skull model of the client / patient. This procedure includes the use of a large amount of textile materials (gauze), and the use of corrosive chemical products of controlled disposal. At present, the subsequent production steps of skin patch have a very low degree of mechanization, such as the process of making the micropores of replicating natural hair matrix, or the subsequent process of applying hair to these holes, which are all manually operated at present. The disadvantage of these methods is that a large amount of time is required to carry out.

[0014] The downside is that in traditional skin patches, the hair is infused rather than tangled, making it less durable over time.

[0015] Therefore, the purpose of this patent application is to provide a new method and a new system for:

[0016] Faster and less invasive acquisition of data about the client / patient (particularly regarding the cranial anatomy of the area to which the patch is applied), which does not require the use of disposable materials and the subsequent creation of a digital replica of the client / patient;

[0017] Faster and more efficient skin patch production. Summary of the invention

[0018] According to the present invention, a system and method for custom manufacturing of skin patches are provided, which effectively solve the above-mentioned problems.

[0019] The method for custom-producing a skin patch can be divided into three main steps: mapping the patient, preparing the working substrate, and applying the hair, and each of these macro-steps can be further divided into multiple steps or sub-steps.

[0020] The first major step of drawing an image of the patient can be further divided into at least 7 steps:

[0021] 1. Obtaining parameters: This involves analyzing and defining the patient's scalp characteristics, such as hair type, color, density and aesthetic characteristics, and then determining the affected scalp area that needs to be covered by the skin patch. This step is very important because it allows you to get a customized setting for the skin patch;

[0022] 2. A transparent film is applied on the patient's head to better capture the shape of the head, and then the operator uses a special kajal pen to demarcate the area involved in the test;

[0023] 3. Automatic detection of the cranial shape using a structured light 3D scanner. Advantageously, this operation best protects the patient's self-esteem and is more environmentally sustainable, since it does not involve the use of materials such as cellophane films, hardened resins and the related application tools, simplifying the work of the operator in charge of the measurement. A structured light 3D scanner is a 3D scanning system that allows the digitization of an object in 3D, reconstructing its geometry through the projection of a coded light pattern. Since the skull varies from person to person, a correct detection of the skull structure is fundamental to obtaining the best results and a perfect fit of the skin patch. 3D scanning using structured light technology enables the detection of the head surface as well as the color mapping (commonly known as texture) used to define the affected area by color differences. Advantageously, structured light scanning technology is safe and harmless to humans, which is why structured light 3D scanners can also be used to scan the human body for medical purposes. With the use of a structured light 3D scanner, this detection step of the patient's cranial structure has been advantageously automated, which allows a significant acceleration of this step compared to the currently used manual method involving the use of a gauze soaked in a hardened polymer material. In addition to the advantageous time saving, this method has two advantages: it causes less stress to the patient associated with the application of chemical products on the skin; no textile materials and controlled disposal of chemical products are used, thus reducing the environmental impact of the entire process; 4. Careful preparation of a CAD model of the "working avatar": starting from the original test data, the scan allows the analysis and preparation of a parametric 3D model (CAD) by special software, which perfectly reflects the affected area of ​​the patient. Advantageously, a digital copy of the patient (digital replica) is created, which increases the accuracy and repeatability of the operation. The "working avatar" is a three-dimensional physical model that reproduces the exact shape of the patient's skull. It includes a craniofacial surface consistent with the model obtained and a connection base with a suction system placed in the part representing the craniofacial surface below. The connection base consists of a cylindrical profile that integrates a thread, which is preferably of the fine pitch "Withworth" type. The choice of this thread is very important because it has a very fine pitch and is used to connect pipes subjected to gas pressure, which will be used in subsequent work steps. The very fine pitch allows a very strong connection to be obtained due to the close proximity of the threads. Together with the gasket, it can withstand high pressures. Therefore, this structure of the working head is advantageous because it resists suction pressure (hair suction described in the following steps). The key feature of the working head is its inner cavity, which allows the pores of the hair follicle matrix located on the skull surface to communicate with the connection base. This inner cavity will allow the hair to be inserted by suction, as described in the subsequent steps;

[0024] 5. Processing of the follicle matrix: Once the modeling of the working avatar is completed, the operator processes the follicle matrix according to the data acquired during the parameter collection step. The follicle matrix consists of special conical holes that represent the distribution of the patient's hair follicles. These holes have a conical shape suitable for receiving and accommodating the hair that will be applied in the subsequent steps, and have the function of aspirating and retaining the hair by connecting to the suction system, which is connected to the previously prepared connection base;

[0025] 6. Preparation of the template by 3D printing using SLA technology (stereolithography);

[0026] 7. Robotic micro-drilling of a matrix of holes presenting the distribution of the hair follicles. This type of robotic micro-drilling consists in automatically creating, with the help of a suitable electronically controlled articulated robot arm, a plurality of conical holes corresponding to the points previously determined with the matrix of hair follicles. More precisely, in order to implement the micro-drilling, it is necessary to use a CNC machine capable of operating on a finished semi-finished product with curved surfaces. The machining of curved surfaces with a CNC machine is feasible with the help of the use of a special contact probe capable of detecting the contours where the drilling operation will be carried out.

[0027] More precisely, the process will proceed as follows:

[0028] - Assemble the template on a suitable housing in the CNC machine;

[0029] -Contour detection by contact probe;

[0030] -Micro drilling using a conical tool.

[0031] Advantageously, innovations in the process allow for the creation of highly precise micro-drilled holes on irregular surfaces.

[0032] The second main step is to prepare the working substrate. First, the template is set up for processing, including the application of a polymer film on its upper outer surface, that is, in the area where the cranial surface and the hair follicle matrix are present. The material most suitable for this application has been determined to be a compact elastic polyurethane.

[0033] The template is then connected to the suction system by means of a simple rotation via the appropriate threaded section.

[0034] The third main step consists in applying the hair, which is divided into the following sub-steps:

[0035] - The operator divides the hair into bundles of 5 mm to 50 mm, preferably 20 mm, each bundle being aligned at the workstation and at the base of the bundle. The operator can then proceed to activate the suction system to start the insertion;

[0036] - Once the suction system is activated, the hair is brought to the vicinity of the suction holes. When the hair simply passes near the template, the existing tapered holes receive the hair therein by inserting it into their appropriate contours;

[0037] - Once the suction of all hairs has been completed and all holes in the template have been filled, the heating system is activated, so that the temperature of the polyurethane approaches the melting point. Once the polymer film is heated, the hair adheres to it by filling the gaps near the holes;

[0038] - Allow the system to cool gradually by turning off the heating system, allowing the polyurethane to solidify. The skin patch is now ready for application to the patient using known techniques.

[0039] Advantageously, this step, which is also carried out automatically by means of the suction process, is faster and less stressful for the operator.

[0040] The advantages provided by the present invention are clear from the above description, and will be more apparent from the accompanying drawings and the related detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] In the following, the invention will be described, by way of non-limiting examples, at least in its preferred embodiments with the aid of the accompanying drawings, in which:

[0042] - Figure 1 A flow chart illustrating the three main steps of the method for manufacturing a customized skin patch is shown: drawing an image of the patient A; preparing a working substrate B; applying hair C and seven sub-steps A1-A7 of the first main step drawing an image of the patient;

[0043] - Figure 2 A working head 1 is shown, which is formed by a template 3 connecting a base 2 and a top, polyurethane 9 is applied to the template 3, and a suction system 4 is positioned below the template 3, which suctions hair 7 into micropores 6 constituting a matrix 5 of hair follicles;

[0044] - Figure 3 A skin patch 8 having a follicle matrix 5 and hairs 7 is shown;

[0045] - Figure 4 An enlarged view of a follicle matrix 5 comprising conical micro-pores 6 in which hairs 7 are fixed is shown. DETAILED DESCRIPTION

[0046] The invention will now be described, purely by way of non-limiting or restrictive examples, with the aid of the accompanying drawings, which show some embodiments related to the inventive concept.

[0047] refer to Figure 1, which describes a method for custom-producing a skin patch 8, which can be divided into three main steps: drawing an image of the patient; preparing the working substrate; and applying hair 7.

[0048] a) Drawing the image of the patient: The purpose of this step is to collect / acquire all the useful information and draw the image of the patient in order to create a digital copy of the patient that can be used in all the production steps of the skin patch 8. The digital copy is nothing more than a virtual replica of the patient's skull, integrating the shapes and features that are useful for the process. This process allows the analysis of the anatomy of the human skull and its properties in a minimally invasive way using digital tools and without the use of materials and techniques that involve invasive mechanical applications on the skin.

[0049] The activity progresses step by step through the collection of parameters, preliminary shaving, and 3D scanning of the cranial anatomy.

[0050] The first main step of drawing the patient's image can be further divided into 7 steps:

[0051] Obtaining parameters of the patient's scalp characteristics, such as hair 7 type, color, density and aesthetic characteristics, and subsequently identifying the affected head area that needs to be covered by the skin patch 8. This step is very important because it allows you to get a customized setting for the skin patch 8;

[0052] a2) application of a transparent film on the patient's head in order to better acquire the skull shape during the examination using 3D scanning, followed by demarcation of said area affected by said examination by the operator using a dedicated kajal pen;

[0053] a3) Automatic detection of cranial structure using structured light 3D scanner: Since the skull cap varies from person to person, the correct detection of the skull cap structure is the basis for obtaining the best results and perfect fit of the skin patch. A handheld scanning device that can be held in one hand is connected to a special PC and faces the patient's head, projecting light through a special emitter to detect changes in it by analyzing the affected surface. The total duration of the process is estimated to be five minutes;

[0054] a4) A CAD model of the working avatar 1 is carefully created by means of special software, which perfectly reflects the area of ​​the patient in question. A digital copy (digital replica) of the patient is thereby created, which increases the accuracy and reproducibility of the operation.

[0055] a5) processing the follicle matrix 5 according to the previously acquired parameters, which consists of special conical holes 6 presenting the distribution of the patient's hair follicles. These holes 6 have a conical shape, are able to receive and contain the hairs 7 that will be applied in the subsequent steps, and have the function of retaining the hairs 7 by connecting them to the suction system 4 connected to the base of the previously prepared working avatar 1;

[0056] a6) preparing the template 3 by 3D printing production using SLA technology (stereolithography). More precisely, SLA 3D printers use photoreactive resins. When stereolithography resins are exposed to light of a specific wavelength, short molecular chains bind together, polymerizing monomers and oligomers into solidified rigid or flexible geometries. Thus, the file containing the 3D model is transferred to the printing device, and the printer produces the template 3 by solidification of a suitable photosensitive resin;

[0057] a7) Robotic micro-drilling of the matrix 5 of holes 6 presenting the distribution of the hair follicles. With the aid of a suitable electronically controlled articulated robot arm, the holes 6 are made with a starting diameter of preferably 1 mm and a lower diameter of preferably 0.5 mm. More precisely, in order to carry out the micro-drilling, it is necessary to use a CNC machine suitable for operating on finished semi-finished products with curved surfaces. The machining of curved surfaces with the CNC machine is feasible by using a special contact probe capable of detecting the contours on which the drilling operation will be carried out. More precisely, the operation will be carried out as follows: the template 3 is assembled on a suitable housing inside the CNC machine; the contour detection is carried out by means of a contact probe; the micro-drilling process is started using a conical tool.

[0058] b) Preparation of the working base: The template 3 is set up for processing, consisting in applying a polymer film on its upper outer surface, i.e. in the area presenting the cranial surface and the matrix of hair follicles 5, and subsequently, by a simple rotation, the template 3 is connected to the suction system 4 through a suitable threaded portion. Three characteristics of the polymer film have been identified: good mechanical resistance, preferably with a thickness of 0.3 to 0.8 mm; good elasticity and flexibility for optimal adhesion to the scalp; transparency, in order to obtain an aesthetic effect that is as natural as possible. The material most suitable for this application has been identified as a compact elastic polyurethane. The application of the polyurethane is carried out by spraying the material automatically or manually. In order to avoid clogging of the micropores 6, a special compressor is connected to the template 3, which will force air through the micropores 6 to remove any residual material therefrom. Subsequently, the template 3 is connected to the suction system 4 through a suitable threaded portion, by a simple rotation. The apparatus required for suctioning 4 the hair 7 through the microporous template 3 can be described as follows: the template 3 is mounted and firmly connected to a suitable working platform (the working platform preferably has a size of about 1000mm x 2000mm) by means of suitable fittings with a Whitworth threaded cylinder; the template 3 is connected to a suitable heating system and a suction pump 4 by means of a resistor; there is a suction pump 4 under the platform, the dimensions of which are particularly suitable for obtaining a vacuum capacity under general conditions. In particular, the value to be obtained is preferably 3×103Pa–1×10-1Pa. The pump has an electromechanical actuator for switching the pump on and off. A special barometer 11 is installed between the pump and the template 3 for monitoring the pump pressure.

[0059] C) Applying hair 7 is carried out by manually or automatically bringing hair close to template 3, which is connected to suction system 4. First, the operator divides hair 7 into bundles of 05mm to 50mm, preferably 20mm, each bundle is aligned at the bottom of the bundle at the workstation. The operator can continue to start suction system 4 to start insertion; once suction system 4 is started, hair 7 is brought to the vicinity of hole 6 manually or by a suitable robot. When hair 7 is simply passed near template 3, the existing tapered hole 6 receives hair 7 therein, placing them in appropriate contours. Once the suction of all hairs 7 has been completed and all holes 6 of template 3 have been filled, the heating system is started so that the temperature of polyurethane is close to the melting point. Once the polymer film is heated, the gap near the filling hole 6 makes hair 7 adhere to it; by turning off the heating system, the system is gradually cooled to solidify polyurethane. Skin patch 8 is now ready to be applied to the patient.

[0060] All the instruments used in the steps of the method just described constitute a system for manufacturing the skin patch 8 object of the present invention.

[0061] The invention is defined by the appended claims.

[0062] Finally, it is clear that modifications, additions or variations obvious to a person skilled in the art may be made to the invention described thus far, without departing from the scope of protection offered by the appended claims.

Claims

1. A method for custom-producing a skin patch (8) for achieving a customized patch for the purpose of hair thickening according to the scalp shape of at least one patient, characterized in that The method comprises the following steps: a) Drawing the patient's image: The purpose of this step is to collect / acquire all useful information and draw the patient's image in order to create a digital copy of the patient that can be used in all production steps of the skin patch (8). The first main step includes the following sub-steps: a1) obtaining / collecting patient parameters, including analyzing and defining the patient's scalp characteristics, such as hair type, color, density and aesthetic characteristics, and determining the affected scalp area to be covered by the skin patch (8); a2) application of a transparent film on the patient's head to better capture the skull shape during the examination using 3D scanning, followed by demarcation of said area affected by said examination by the operator using a dedicated kajal pen; a3) Detecting the skull shape by 3D scanning the head and using structured light; a4) analyzing and processing the parametric 3D model (CAD) based on the aforementioned scan (a3), which perfectly reflects the affected area of ​​the patient, and subsequently generating a digital replica of the patient, which allows accuracy and repeatability of all operations, created with the help of dedicated software for designing a working avatar (1), which consists of a physical three-dimensional model that replicates the skull surface (10) and corresponds to the model acquired: wherein the working avatar (1) also includes a connection base (2) having a suction system (4) arranged in a portion located below the skull surface replica (10); a5) after completing the CAD modeling of the working avatar (1), processing the hair follicle matrix (5), which consists of a plurality of conical holes (6) representing the distribution of the patient's hair follicles according to the parameters obtained in the previous steps a) and c); a6) producing a structure of a template (3) or a mold suitable for replicating a skin patch (8) using 3D printing using SLA technology (stereolithography) and mounting said template (3) on a dedicated housing in a CNC machine that needs to work on the curved surface of the finished product / finished semi-finished product for robotic micro-drilling; a7) performing robotic micro-drilling using a conical milling tool, including automatically realizing the plurality of conical holes (6), the conical holes (6) corresponding to points previously determined using the hair follicle matrix (5); b) preparing the template (3) for further processing, comprising applying a polymer film having a thickness of 0.3 to 0.8 mm, preferably made of compact elastic polyurethane (9), on the upper outer surface of the template, i.e. in the area representing the cranial surface (10) and the hair follicle matrix (5); b1) connecting a special compressor to the template (3), which will push air through the micro holes (6) to remove residual material therefrom, if any; c) connecting the template (3) to the suction system (4) by pure rotation using a dedicated threaded portion (12) suitable for engaging with the connection base (2), and subsequently applying 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 dedicated / corresponding conical hole (6); c2) heating to bring the polymer film (9) close to the melting point, thereby implanting the hair (7) therein and obtaining the desired natural hair effect; c3) cooling until the polymer film (9) has reached room temperature again.

2. The method for custom-producing a skin patch (8) according to claim 1, characterized in that Said robotic micro-drilling according to sub-step a7) is performed by using a numerically controlled machine suitable for operating / acting on finished semi-finished products with curved surfaces.

3. A system for custom production of skin patches (8) for realizing customized patches for the purpose of hair thickening according to the scalp shape of at least one patient, characterized in that It can be used in a method according to any one of the preceding claims and in that it comprises at least the following elements: Structured light 3D scanners, which are suitable for detecting head shapes; Dedicated software for post-processing the data acquired by the 3D scanner in order to perfect the acquired surfaces; a template (3) obtained by 3D printing using the SLA technique (stereolithography) suitable for replicating the shape of the skin patch (8); a numerically controlled machine equipped with a contact probe, said machine being suitable for performing micro-drilling of the template (3); a working avatar (1) replicating the patient's cranial surface according to the model obtained during the 3D scanning described in sub-step a3), comprising a suction system (4) suitable for sucking hair (7) into said conical micro-holes (6) replicating the hair follicle matrix (5), and also comprising a heating system suitable for fixing said hair (7) in said conical micro-holes (6); a compressor which, after application of a polymer film, preferably polyurethane (9), on the template (3), pushes air through the micropores (6) to remove residual material therefrom, if any; A suction system (4) for sucking the hair (7) into the conical micro-holes (6).

4. System for custom production of skin patches (8) according to the preceding claim 3, characterized in that To realize the working head (1), the system comprises a connection base (2) formed by a cylindrical profile incorporating a thread (12), preferably of the Whitworth type with fine pitch and suitable for ensuring a stable connection between pipes subjected to gas pressure.

5. A system for custom production of a skin patch (8) according to any one of the preceding claims 3-4, characterized in that The working head (1) comprises an inner cavity for interconnecting the base (2) and the conical holes (6) of the hair follicle matrix (5) arranged in the cranial face (10), and for allowing the insertion of the hair (7) by suction.

6. System for custom production of skin patches (8) according to any one of the preceding claims 3, 4 and 5, characterized in that The polymer film (9) used to prepare the template (3) to be processed / treated is made of compact elastic polyurethane (9).

7. System for producing a skin patch (8) according to any one of the preceding claims 3 to 6, characterized in that It comprises a robot adapted to bring the hair (7) close to the template (3) when the suction system (4) is in operation, so as to allow the hair to be inserted into the conical hole (6).

8. System for producing a skin patch (8) according to any one of the preceding claims 3-7, characterized in that The suction system (4) is suitable for reaching 3×103Pa-1×10-1Pa.

9. System for producing a skin patch (8) according to any one of the preceding claims 3 to 8, characterized in that The suction system (4) comprises a barometer (11) for pressure assessment and control.

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