Description

Field of the art

The present invention refers to a non-surgical method for treating baldness. More in detail the present invention regards a particular medical kit comprising devices for use in the treatment of baldness in oncological patients subjected to chemotherapeutic treatments. Still more in detail the present invention regards a particular highly-customizable skin patch to be applied on the skin of the head portion of the patient which manifests baldness.

Prior art

Antineoplastic or antitumoral chemotherapy is the therapeutic treatment that consists of administering chemical substances for the purpose of eliminating the tumor cells and preventing the proliferation thereof. In the course of the therapy, also the healthy cells characterized by a quick replication could be eliminated, such characteristic shared by the tumor cells (other fast-replicating cells include hair bulb cells, blood cells, gastric mucous membrane cells). The drugs used for preventing or combating the development of tumors are antineoplastic or antiblastic drugs, which in the therapeutic and chemical anatomic classification system are classified as L01. Usually, multiple antineoplastic drugs are administered according to a. procedure termed polychemotherapy. The main object of a polychemotherapy regime is to prevent the selection of a neoplastic population that is resistant to drugs (resistance). In addition, the effect of an association of drugs is generally greater (synergy) than the sum of the effects of the single agents used in monotherapy: this allows obtaining the same results with a lower dosage and consequently with lower toxic effects for the organism. This is particularly important for drugs which have, like the antineoplastics, a low therapeutic index. One of the most feared and widespread side effects is represented by the loss of the hairs from the subjects who undergo the treatment. Not all the drugs cause hair loss, actually sometimes the phenomenon is so light as to be hard to recognize; in some cases, instead, the hairs can partially or completely fall, and in other cases even the eyebrows, eyelashes, pubic hairs and hairs that cover the rest of the body can also fall. The degree, the time of appearance and the impact of the loss of the hairs depend on the drug or on the combination of drugs with which the treatment is actuated, on the dosage and on the mode with which the patient responds to the treatment. In any case, before starting the chemotherapy, the oncologist illustrates all the potential side effects of the treatment and hence also of hair loss.

Usually, the hairs start falling in the course of a few weeks from the start of therapy, even if in some cases, quite rarely, the phenomenon can appear in the course of a few days. The first signal are the hair locks that fall when one brushes or combs or washes with shampoo, and which are sometimes found on the pillow upon waking. The hairs can be thinned or become dry and fragile, and consequently they tend to be easily broken off. In some cases, they can continue to fall for several weeks, up to leaving the head completely bald. In rare cases, the loss is very sudden and is completed in a couple days. Not only is this psychologically very' stressful, but this is also uncomfortable since the scalp results painful or inflamed. The hair loss is generally reversible and the hairs can start to regrow even before the end of therapy. This is possible because the hair and skin follicles, like the other healthy cells of the organism, even if damaged by the chemotherapy, are quickly restored.

Initially the hairs are very thin, but over the course of 3-6 months the head of hair returns as thick as before. The “new” hairs can be curlier or finer than before, and sometimes they can have slightly different color. Sometimes a mix between black and gray. In very/ rare cases, especially after the administration of high chemotherapeutic doses (such as for treatment with base of cyclophosphamide, thiotepa, carbopl atin for blood tumors and after bone marrow transplant), the hairs might no longer regrow.

The aforesaid greatly-impacting conditions dictated by chemotherapeutic treatments have undoubted importance from the psychological standpoint, thus rendering indispensable the search for solutions that can at least alleviate the aforesaid side effect from chemotherapy, at least from this standpoint.

In such context, the present invention has application, the object thereof being that of alleviating the psychological effects induced in patients which are subjected to the consequences of the side effects of chemotherapeutic treatments and especially due to hair loss. More in detail, as will be described hereinbelow, the present invention regards a particular skin patch that is highly customized for patients subjected to chemotherapeutic treatments that induce hair loss.

Description of the invention

The present description regards a particular and innovative kit for use in the therapeutic treatment of subjects subjected to chemotherapy. More in detail the present invention regards a kit comprising at least two devices, one which forms a mold and another that forms a skin patch and in particular with characteristics such to be a patch that is highly customized for the wearer subject, such that the latter perceives the same patch, which as will be described hereinbelow comprises a hair graft, highly similar to the native head of hair thereof and in any case similar to that pre-existing the chemotherapy, thus minimizing the psychological repercussions due to the inevitable loss of hairs in grave oncological patients.

The present description also refers to a method for attaining the present system which comprises a series of steps regarding the preparation of the mold and of the final skin patch. The steps of the method according to the present description follow a preliminary study step directed on the patient, a step which - it must be specified --- does not fall within the method whose protection is requested. Nevertheless, it is of interest for the Applicant to indicate that also said step preceding those of said method does not in any case provide for invasive interventions on the patient.

On such matter, and only for the purpose of a more in-depth description, it is indicated herein that the definition of the present system, which, as stated above, comprises at least two devi ces including one which forms a mold and the other which forms a skin patch, first of all provides for a preliminary step consisting of a detailed descriptive analysis of the area to be treated with the intention of accurately determining the skin area to be hair-thickened, first of all by means of visual evaluation by the technician.

Once the area has been determined, it is provided to cover the head of the patient with a transparent film (like those used for food use) on which, by means of a black kajal pencil, the perimeter of the baldness is drawn, i.e. the area to be hair-thickened is graphically identified, which is to be subsequently covered with the patch that is custom-made.

Once the area is drawn, provision is made to cover the same with bandages made of resin (e.g. phil cast) which are crossed together, actually creating a compact surface to determine the area to be hair-thickened. Allowing the mold of bandages made of resin to harden, the hair whorl, the front centerline of the mold and possibly the graft/transplant direction of the hairs themselves are first indicated, then subsequently the mold is removed from the head of the patient.

The mold thus obtained, once removed from the patient, is therefore subjected to the steps of the method according to the present invention, such method first of all providing that below the mold, there are distinctive sections of the area to be hair-thickened. At this point, with suitable cutters, the area of the mold is suitably cut such that the outside of the cranial shape is actually attained, which will come to accurately reproduce the cranial shape of the patient, including possible cranial troughs. The final finishing of the mold is carried out by means of suitable files that will come to smooth the perimeter thereof. All the structural parameters of the future skin patch are marked on a technical sheet of the patient. More in detail, the following are defined: the border from which the area to be hair-thickened departs, and which will then become the starting point for the patch; the dimensions of the mold; the hair color (1-2-3-4-5-6-7-8-9); the hair type, i.e. if wavy, smooth, or curly, the hair length, typically 15/20 cm for standard hair and 30/35 cm for extra-long hair; the density (thin about 90 hairs per cm, medium-thin about 110 hairs per cm, medium about 130 hairs per cm, medium thick about 150 hairs per cm, thick about 180 hairs per cm); the hair distribution, for example if natural i.e. with hair whorl and rotary sense as provided in nature or directional (for head portions to be restored); the grizzling. On such matter is it of interest to indicate that the grizzling typically has 8 personalization sections, as in the enclosed scheme, and can vary by

5% intervals starting from 5% to 100% and is exactly calculated in %.

Once the geometric and analyti cal step for patient baldness has terminated (such baldness can have any shape, from total to partial covering of the cranium), the technical working module is prepared which will allow determining the quantity of hairs necessary for making the patch. Once the weight of the hairs themselves has also been determined (such weight varying based on the color type (typically light colors weigh less) and based on the length, provision is made to select the selected color and all is arranged for the production of the mold, which occurs according to substantially known techniques which, as they are known, will not be detailed in the course of the present description.

Once the mold is prepared and simultaneously, but separately, the virtual representation of the head of the patient is attained, the expanded polyurethane is made to foam below the mold, thus determining the head portion affected by the thickening. The avatar of the patient thus made, said head portion to be hair-thickened is covered with a thin film of medical polyurethane and the non-surgical transplant of hairs initiates, which thus occurs directly on the avatar of the patient according to technical and style characteristics of the same.

Said method provides that, during the attainment of the skin patch, the hair distribution must occur in accordance with the technical evaluation carried out by the hair designer. All this with the intention of accurately reproducing the head portion lacking hairs.

Once the manual or automated single graft/transplantation of each hair present on the patch has terminated, said method provides that the latter be removed from the avatar. All this with the result that the patch thus obtained represents a structure that is like a synthetic “scalp” of the patient himself/herself. This synthetic scalp structure, i.e. the skin patch of the system according to the present invention, is at this point ready to be adapted on the head of the patient with dermatologically-tested adhesives (such as for example the adhesives of the transdermal bandages), optionally comprised in the present kit and made integral with the patient, who may do whatever he/she wishes.

Since these are patches made with natural, untreated European hairs, said patches are such to be able to be totally personalized even with regard to shape and color.

Advantageously, the use of the kit according to the present invention and in particular the application of the skin patch compri sed therei n represents, above all in the female population, an essential support for transforming a difficult moment into a path of psychic wellbeing, which has revealed itself useful also for researching new looks and discovering “oneself new” - which distracts and helps at the psychological level.

Advantageously, said approach also allows searching for a “new” look for the future, that can be reached as soon as possible and which advantageously will more quickly lead the patient to “normality”.

The present invention will be described in detail hereinbelow, also with reference to the enclosed figure in which:

FIGURE 1 shows a perspective view of the skin patch 1 of the medical kit according to the present invention. More in detail the figure in question shows a plan view of the head of a subject, on which said skin patch 1 is applied in a predetermined area, said skin patch 1 having the hair graft/ transplantation (not shown in the figure in question). The application of said skin patch 1 is typically, but not exclusively, performed in subjects with areas of the head affected by baldness due to chemotherapeutic treatments.

Detailed description of the invention

The present description refers to a particular medical kit and in particular to a kit for use in the therapeutic treatment of oncological patients subjected to chemotherapeutic treatments that induce hair loss.

Stil l more in detail, the present invention regards a medical kit comprising at least two devices and in particular at least a first device which forms a mold and at least a second device which forms a skin patch 1.

The present invention also refers to the method for making said medical kit and especially for obtaining one of its components, i.e. the skin patch 1, comprising a plurality of steps which follow a study step, excluded from said method, which provides for the intervention on the patient, such intervention in any case being non-invasive as specified above.

More in detail and as mentioned above, the method according to the present invention follows an analytical step for studying the skin of the patient’s head which manifests baldness induced by the chemotherapy so as to attain a mold that will act as a guide model for the attainment of the final skin patch.

Said method therefore sequentially provides for the actuation of the following steps, which provide for (starting from the attainment of a mold previously obtained from a visual and automated scanning of the skin of the head of the patient and from the manual or automated superimposition of bandages made of resin, wherein said mold accurately represents the profile of the skin portion of the head of the patient to be subjected to artificial hair thickening, including all the possible curves or troughs or generally also slight irregularities for each subject):

- the finishing of said mold by means of automatic or manual filing with suitable files suited to smoothen the perimeter of said mold;

- annotation of the aesthetic features of the mold which include: the definition of the area to be hair-thickened to a greater extent, color and type of hairs if curly, smooth or wavy, hair length, hair distribution, hair growth vortex direction; grizzling;

- attainment of an avatar of the patient’s head and superimposing said mold on said avatar,

- foaming of a polymeric material on the concave surface of said mold, said material being expanded polyurethane, as a non-limiting example; said foaming allowing the reproduction also of the area to be hair-thickened to a greater extent;

- covering of the foamed polyurethane as prepared at the preceding step, with a very thin polyurethane film for medical use;

- automated or manual graft/transplantation of available synthetic and/or natural non-treated hairs;

- the removal of the skin patch obtained from the preceding step from said avatar of the patient’s head.

This final structure, i.e. the skin patch thus obtained, represents a kind of synthetic scalp of the patient himself/herself. Said skin patch is thus highly customized and specific for a given patient and is ready to be applied on the skin of the head portion of the subject which manifests baldness. The adaptation occurs by means of the use of known adhesives, dermatologically tested, by way of a non-limiting example said adhesives are analogous to those present in the transdermal medical bandages.

Several embodiments according to the present invention provide that said adhesives are comprised in said kit.

It is also of interest to indicate that the skin patch of the kit according to the present invention has a hair graft which can be subjected to the same aesthetic treatments to which natural hairs can be subjected, i.e. dyes or hairstyles. For such purpose, further embodiments according to the present invention provide for the inclusion of packages of dermatologically-tested dyes for hairs meeting the needs and aesthetic tastes of the wearer patient of the skin patch.

The skin patch 1 according to the present invention in substance comprises a. biocompatible polyurethane film with natural and/or synthetic hairs enclosed that meet the national and international norms for their use in the medical field.

For the purpose of a more complete and exhaustive description, it is also reported that the skin patch 1 according to the present invention requires monthly periodic maintenance, which provides that said device is removed from the patient, hygienized, regenerated or reapplied. The specialized operator will carry out said maintenance sendee within dedicated structures. Generally, the service is to be supplied preferably at least monthly but one must always take the needs of the patient under consideration.

Once the actual widespread and regular growth of the patient hairs has been verified, the skin patch is no longer necessary' and therefore can be removed, thus allowing the patient to restart his/her normal life.