(19)
(11) EP 4 389 101 A1

(12) EUROPEAN PATENT APPLICATION

(43) Date of publication:
26.06.2024 Bulletin 2024/26

(21) Application number: 23214711.6

(22) Date of filing: 06.12.2023
(51) International Patent Classification (IPC): 
A61H 7/00(2006.01)
A46B 13/00(2006.01)
(52) Cooperative Patent Classification (CPC):
A61H 7/005; A61H 2201/169; A61H 2201/0157; A61H 2201/1654; A61H 2201/1671; A61H 2201/1676; A61H 2201/1685; A61H 2201/0107; A46B 13/008; A46B 2200/102; A46B 5/0095
(84) Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC ME MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated Extension States:
BA
Designated Validation States:
KH MA MD TN

(30) Priority: 23.12.2022 IT 202200026775

(71) Applicant: D'Ambra, Francesco
6612 Ascona (CH)

(72) Inventor:
  • D'Ambra, Francesco
    6612 Ascona (CH)

(74) Representative: Giugni, Diego et al
Propria S.r.l. Via della Colonna, 35
33170 Pordenone
33170 Pordenone (IT)

   


(54) DEVICE FOR SKIN TREATMENT


(57) The present invention relates to a skin massage device and, in particular, to a device capable of treating the skin in a more precise and effective manner with respect to any manual treatment. As a matter of fact, the device is characterised by a head provided with a functional portion which can be automatically driven in rotation/oscillation specifically studied to improve the treatment conditions and avoid tiring the staff. Furthermore, the invention relates to a scalp massage method, capable of increasing the laxity thereof through said device and a cosmetic hair transplant method comprising said scalp massage method.




Description

TECHNICAL FIELD OF THE INVENTION



[0001] The present invention relates to a skin massage device and, in particular, to a device capable of treating the skin in a more precise and effective manner with respect to any manual or mechanical treatment. Furthermore, the invention relates to a scalp massage method, capable of increasing the laxity thereof through said device and a cosmetic hair transplant method comprising said scalp massage method.

STATE OF THE PRIOR ART



[0002] The skin treatments may comprise numerous types depending on the condition of the person. They can be of the invasive type, that is of the surgical type for example after lesion or transplantation damage, pharmacological for treating diseases or simply mechanical by massaging.

[0003] Irrespective of the type of treatment, the method of interaction with the skin is crucial for the success of the final result. Currently, the treatments specifically regarding the field of trichology, and that is transplantation surgical treatments with the relative pre-operative as well as postoperative preparation, and the application of drugs, are operations carried out by the medical or specialised nursing staff, which intervenes manually. In other words, especially in the field of trichology, any intervention is left to the manual skills of the physician or operator in general. As a result, there is no control and a repeatability of identical treatment conditions which can validate a method scientifically.

[0004] Furthermore, for example in the case of pre- or post-surgery scalp release massage, the manual massage could cause the irritation and reddening if not performed by experienced staff. In any case, besides having rather long times, the treatments are difficult for the operator given that they require at least 30 minutes per day and they cause fatigue and contractures on the upper limbs and on the neck.

[0005] There are known some devices used in the cosmetics industry for face cleaning and skin treatment in general. For example, the document US2016045081 describes a device comprising a cleaning head with a main cleaning surface provided with a plurality of cleaning elastomeric elements and an actuator which causes oscillations to said elements. The elements may vary in the forms, but generally they are very small elements given that they are present on the cleaning head with a density from 2 to 100 elements per square centimetre. Therefore, their action may be only superficial or at most at the skin level but it does not reach the deepest under skin layers so as to obtain a target action on the scalp. Furthermore, a head with the aforementioned element density - when mobilised - is activated in excessively large areas in an uneven manner, with the risk of complicating a potential inflammatory situation.

[0006] Document WO01/56529 discloses a facial treatment device comprising a support for a brush with bristles joined in tufts arranged so as to define a winding surface and collection areas for creams and lotions.

[0007] Document EP3944786 discloses a device comprising a facial skin exfoliation head which can be interchanged with a teeth cleaning head. The first head consists of an abrasive bearing, the second is a teeth cleaning bristle head.

[0008] Each of the aforementioned documents shows active elements that are conical-shaped, pyramid-shaped or with bristles that do not allow to keep the hair free, with the risk of trapping it and uprooting it at the root. In addition, such elements rub against the scalp not adhering well, resulting in the increase in the production of sebum and inflammatory condition. A further drawback lies in the production of tensions linked to the unprecise mobilisation of the skin, not being able to compact the tissue and creating rigidity of the treated areas.

[0009] All these drawbacks make the heads of the prior art devices entirely inappropriate, if not harmful, for the purpose of carrying out a functional skin massage for releasing the hair transplant scalp in pre- or post-surgery conditions.

SUMMARY OF THE INVENTION



[0010] Therefore, the technical problem underlying the present invention lies in providing a skin massage device which replaces the manual action of any operator and at the same time avoids the drawbacks linked to prior art facial treatment and cleaning devices described above.

[0011] Such problem is overcome by a skin massage device provided with elements capable of administering treatments under conditions that can be controlled scientifically and that are specifically adapted to release the scalp in hair transplant pre- or post-surgery conditions.

[0012] Therefore, a first object of the present invention is an automated skin massage device.

[0013] A second object is a skin massage device capable of obtaining a perfect degree of release of the scalp without side effects.

[0014] A third object is a skin massage device that avoids irritation.

[0015] A further object is a skin massage device that can act precisely and effectively.

[0016] A yet further object is a scalp massage method comprising the use of aforementioned device, as well as a cosmetic hair transplant method comprising such scalp massage method.

BRIEF DESCRIPTION OF THE FIGURES



[0017] Further characteristics and advantages of the skin massage device according to the present invention will become more apparent from the following description of some embodiments provided purely by way of non-limiting example, with reference to the following figures, wherein:
  • figures 1A-1B respectively show a front and a lateral schematic view of the skin massage device according to the invention;
  • figures 2A-2B respectively show a front and a lateral schematic view of a head of the device of figures 1A-1B according to a first variant embodiment of the invention;
  • figures 3A-3B respectively show a front and a lateral schematic view of a head of the device of figures 1A-1B according to a second embodiment of the invention;
  • figures 4A-4B respectively show a front and a lateral schematic view of the device of figures 1A-1B with the head modified according to a variant;
  • figures 5A-5B respectively show a front and a lateral schematic view of the head of figures 2A-2B according to a variant;
  • figures 6A-6B respectively show a front and a lateral schematic view of the head of figures 3A-3B according to a variant.

DETAILED DESCRIPTION OF THE INVENTION



[0018] With reference to figure 1, the skin massage device of the present invention is indicated in its entirety with reference number 1.

[0019] The device 1 comprises a main body 2 and a head 3. In general, the main body 2 contains command and control components required to actuate the functional part of the device, while the head 3 comprises the functional part 5, that is the part active for the treatment.

[0020] In particular, the head 3, according to a first embodiment of the invention, comprises a shaft 4 for transmitting motion to the functional part 5 of the head. Said shaft extends along a straight axis X-X from a first end 40 for the reversible coupling with the main body 2 to a second end 41 (figure 1B) carrying said functional part. The internal of the shaft 4 is then hollow so as to house a transmission (not shown) of the motion controlled by a suitable motor (not show) positioned in said main body.

[0021] The motion transmission is a conventional rod connected to an electric motor and an eccentric so as to be made to vibrate/oscillate. The vibration/oscillation thereof is then transmitted to the functional elements of the head. This kind of system has been long known and for example applied to electric toothbrushes for domestic use.

[0022] Advantageously, according to the present invention, the functional part 5 of the head 3 comprises a plurality of elastic elements 50 that is hollow and open. These elements are made of natural or synthetic rubber, cylindrical or cubical-shaped and they have a diameter/diagonal measuring from 2 mm to 8 mm and a height from 3 mm to 10 mm, more preferably a diameter of 5 mm and a height of 5 mm or 7 mm.

[0023] Furthermore, the cylinders/cubes comprise inner ribs 6 which extend radially from the peripheral to the centre and they are distributed along the inner circumference in an equally spaced manner. In addition, such ribs may be divided into primary and secondary, the primary being thicker and more extended towards the centre of the axis of the cylinder; the secondary being thinner and shorter. Such ribs have the purpose of stiffening the cylinder of the elastic elements in differentiated areas and also to differentiate the degree of stiffening, still elastic, along the circumference of the cylinder. Furthermore, the ribs create seats for the collection and controlled release of lotions or creams for treating the skin during the massage. A further important advantage lies in the fact that the collection seats also act as small cavities for delimiting/containing single follicles which, thus circumscribed, are massaged in a separate and isolated manner, therefore with a very specific and targeted action thanks to the optimal adhesion of the elements to the skin.

[0024] According to the invention, the number of elements per head ranges from 4 to 10 given that it has been experimentally seen that a greater number of elements with dimensions and the aforementioned structure and dimensions causes irritation, inflammation and it does not allow to obtain the due laxity. As a matter of fact, without being bound to theories, a circumscribed action was very effective with respect to a much broader action which would affect the tissue portions not involved in the treatment which somehow interact with the tissue to be treated in a non-optimal manner.

[0025] According to a first embodiment, as shown in figures 1A and 1B, the functional part 5 of the head 3 is an elliptical disc 55 with a first face 51 for engagement with said second end 41 of the shaft 4 of the head 3, and a second face 52 to which the aforesaid elastic elements 50 provided with the aforementioned ribs 6 are fixed preferably removably. The first face 51 and second 52 face are such to have their plane parallel to the axis X-X of the shaft 4. Furthermore, preferably, the elastic elements 50 distributed on the two halves of the elliptical disc divided by the aforementioned axis X-X (figure 1A). In this manner, there are formed two rows 53 of elements arranged in a mirror-like fashion with a central portion 54 of the disc without elements. Furthermore, preferably, the rows 53 are each formed by three elements 50 which are arranged along a circle arc. The elements 50 are then of the same size both in height and diameter and, preferably, they have an outer diameter measuring 5 mm and measuring 7 mm height-wise. Still, preferably, the elements in the rows are spaced apart from each other so as to leave a space in a transversal direction with respect to said axis X-X. In other words, the elements are arranged two by two aligned in the orthogonal direction with respect to said axis X-X.

[0026] This arrangement has the advantage of allowing a processing on larger surfaces and a processing on tissues to be treated a tension greater than normal, that is for stiffer areas. It is used for non-virgin scalps, surgically speaking, with widespread scars following procedures using the FUE (Follicular Unit Extraction) or FUT (Follicular Unit Transplantation) technique. The particular position allows a more intense and deeper oscillation of the tissue, given that the treated area will not be circled, but moved rapidly by 2-4mm. This rapid movement allows to release the deep tensions and the cicatricial tissue.

[0027] According to a second embodiment, as shown in figures 2A and 2B, the functional part 5 of the head 3 is a circular disc 56 with four elastic elements 50 arranged in a cross-like fashion along the circumference of the disc and a central position, each provided with the aforementioned ribs 6. The position of the first 51 and second 52 faces of the disc and the ends of the shaft 4 are identical to the ones described above. Preferably, the central elastic element has a smaller height with respect to the four circumferential cross-like elements.

[0028] The advantage of this arrangement lies in the fact that it facilitates the processing of tissues where there is required a precise work and the tissues have a normal tension. In particular, the central support allows to anchor and stabilise the scalp, making it a firm point. The other four supports mobilise the tissue with a movement which allows the skin to be released from the skull and therefore increase scalp laxity.

[0029] In addition, besides increasing micro-circulation by indirect action, the device allows to mainly increase skin laxity, reducing the tensions of the treated area, working up to the epicranial aponeurosis. The particular position of he heads, combined with the oscillations repeated rapidly, create space between the skin, the subcutaneous tissue and the epicranial aponeurosis, causing micro-lesions, increasing the production of fibroblasts and collagen. This new tissue allows to generate skin laxity, which is key to preparation for hair transplant surgery.

[0030] It should be observed that the particular inner cross-like structure of the elements with ribs, also thanks to the formation of a chamber measuring 9.5-500 square mm, that is the chamber defined by the internal space of each element 50, allows to work directly on the individual follicles, receiving and mobilising them delicately. This creates the precise release of the scalp, focused on the single follicular areas to be treated. This particular arrangement further allows to keep the sebum balance intact, given that the non-closed cross-like structure allows an exchange and balancing between the various areas, avoiding to stress the follicles.

[0031] According to a third embodiment, as shown in figures 3A and 3B, the functional part 5 of the head 3 is a circular disc 57 identical to the one described above but with only four elastic elements 50 provided with ribs 6 arranged in a cross-like fashion so as to leave a space 58. In particular, all four elastic elements 50 have the same height and diameter.

[0032] The advantage of this arrangement lies in the fact that it enables to work on larger surfaces and a processing on tissues that have tension that is greater than normal.

[0033] The main body 2 may for example be cylindrical and terminate with a truncated cone portion 20 for the fitting of the aforementioned shaft 4 of the head 3. In particular, the body is internally hollow and it houses several components (not shown) for commanding and controlling the movement of the functional part 5 of the head 3. Generally, said components comprise an electric motor for activating the rotation/oscillation of a rotating/oscillating shaft which transfers the motion to said functional part through a rod provided with an eccentric.

[0034] Further components comprise a switch for turning on, turning off and adjusting the velocity and/or width of the rotation/oscillation, a rechargeable battery for storing power for supplying the motor, warning lights for indicating the charge-level of the battery and the turning on of the device.

[0035] The type of components mentioned above may consist of conventional components provided for and extensively known for electric toothbrush.

[0036] It was observed that driving in rotation/oscillation the aforementioned head 3 provided with the aforementioned elastic elements 50 with 4,500 to 9,000 rotations/oscillations per minute, also up to 12,000-24,000 oscillations per minute, allows to obtain an efficient skin treatment. Furthermore, the angle of oscillation between the axis X-X and the elastic elements 50 is comprised between 50° and 70°; a larger angler could potentially ruin the follicular units irreparably damaging the bulbs as well as irritating the scalp, while the smaller angle would not allow an effective release.

[0037] The possible treatments may comprise: pre-surgery FUT (Follicular Unit Transplantation, a hair transplant surgical procedure which envisages the removal of a scalp strip from which the follicular units are extracted), virgin scalp, preparing for surgery to the increase of the scalp laxity for the first surgery and preparing the donor and recipient area; pre-surgery FUT non-virgin scalp, preparing for the surgery to increase the laxity and mobility of the scar and preparing the donor and recipient area; pre-surgery FUE (Follicular Unit Extraction, hair transplant surgical intervention which envisages the removal of the individual follicular units), for preparing the scalp to the surgery of the donor area, facilitating the collection of the individual follicular units, and to prepare the recipient area; post-surgery FUT and FUE for the tension reduction treatment due to the scars; post-surgery, to reduce the tensions of the scars; supporting with trichology treatments.

[0038] As a result, a further object of the present invention is a scalp massage method comprising the steps of:
  • providing a device as described above;
  • placing the head of said device on an area to be treated;
  • activating the device for 4-6 minutes per day, for 30-60 days, with 4,500 to 24,000 rotations/oscillations per minute and with an oscillation angle comprised between 50° and 70° so as to obtain skin laxity, and following the surgery lines and/or the lines of the donor area.


[0039] The steps described can be repeated on each area to be treated individually and specifically so as not to affect areas not subjected to treatment and which should not be treated and, therefore, avoiding to involve tissue portions which could interfere with said areas.

[0040] The aforementioned method is particularly advantageous when implemented in a hair transplant cosmetic treatment method, as a pre- or post-surgery stage as described above. As a matter of fact, as explained, the massage allows to obtain an optimal degree of laxity both for preparing the scalp for the hair transplant and for reducing the tensions of the scars after the transplantation.

[0041] Furthermore, the method may comprise a step for applying a skin cream or lotion on the scalp and/or on the head of the device before the step of placing the head on the scalp.

[0042] Treatments carried out with the device of the present invention revealed to be particularly effective in accelerating the release process in all the cases described above. Basically, it was observed that by treating various conditions, the use of the device allowed to reduce the treatment time by 96%. Considering the obtained average advantage of 7mm per cm2 of laxity on the treated area, in 5 months of treatment, there is required an overall use of the device of 300 minutes against the 9000 minutes of the manual technique. Furthermore, the deep and precise work of the head allows to release the tissues and restore elasticity evenly on the entire area to be treated.

[0043] Furthermore, the quality of the result is also significantly greater. As a matter of fact, the skin and the hair appear healthier and without irritated areas caused by excessive and erroneous rubbing. With the manual approach, if not performed perfectly, there is often the risk of ruining the physician's work. With the use of the device, the responsibility does not lie with the patient, who is forced to carry out endless exercises, because the ease of use of the device allows constant and daily effort reducing stresses and risks to the minimum. The use of inappropriate devices is also avoided in order to prevent the aforementioned problems.

[0044] In the light of the above, it is clear that the drawbacks of the manual technique or with the prior art devices for the skin treatment outlined in the introductory part of the present description have been overcome and, at the same time, significant advantages have been achieved both in terms of effectiveness and in terms of substantial reduction of fatigue for the operators.

[0045] It should be observed that the device of the invention may also be subjected to variants and modifications, all within the reach of the person skilled in the art, but without departing from the scope of protection of the attached claims.

[0046] For example, the number of rotating/oscillating elastic elements may vary within the aforementioned range depending on the specific needs or preferences depending on the conditions of the subject. The arrangement of the elements may be modified with respect to the one described in the embodiments.

[0047] The materials may vary depending on the specificity of the treatment or of the subject, such as specific allergies or characteristics of a product to be applied.

[0048] In particular, as shown in figures 4A-4B to 6A-6B, the elastic elements 59 respectively of the functional part 5 of the heads respectively 55, 56 and 57 have a square-shaped internal profile, while the rest of the device remains identical for each embodiment.

[0049] The presence of the ribs, as well as the distribution thereof may still vary depending on the treatment conditions and the subject, same case applying to the frequency of rotation/oscillation which can be set in the device.

[0050] The size - in height and diameter - of the single elements may further vary within the aforementioned range for each head so as to create a variability of treatment plans.

[0051] The massage method allows to specifically prepare the skin areas for pre or post hair transplant surgery so as to reduce the laxity and, therefore, obtain an optimal transplant result.

[0052] Embodiments of the invention are shown below.

EXAMPLE 1



[0053] 43-year-old male patient at his third FUT surgery, has an initial laxity of 3mm. After the daily use of the device in the areas to be treated for 4 minutes per day for 45 days there was observed a 7mm increase in laxity reaching a total laxity of 10mm.

EXAMPLE 2



[0054] 22-year-old male patient at his first FUT surgery, has a 13mm laxity. After the daily use of the device in the areas to be treated for 4 minutes per day for 30 days there was observed a 11mm increase in laxity reaching a total laxity of 24mm.

EXAMPLE 3



[0055] 68-year-old female patient at her first FUE surgery, has a widespread rigidity, 4mm laxity, and a risk of rejection of the follicular units of the recipient area. After using the device in the areas to be treated for 4 minutes per day for 45 days, she had an 8mm laxity increase, reaching a total laxity of 12mm.

EXAMPLE 4



[0056] Male patient at his second FUE surgery, has a rigidity of the donor area, laxity of about 5mm, with a high risk of shockloss in the recipient area and in the donor area. After using the device in the areas to be treated for 4 minutes per day for 30 days resulted in the increase of laxity by 8 mm, reaching a total laxity of 11mm.


Claims

1. Skin massage device (1) comprising a main body (2) and a head (3), wherein said main body (2) contains command and control components required to actuate the movement of a functional part (5) of said head (2), and said head comprises a movement drive shaft (4) which extends along a straight axis (X-X) from one connection end (40) with said main body (2) and a second end (41) connected to said functional part (5) provided with a plurality of hollow and open elastic elements (50;59) which rotate/oscillate under the action of said command and control components transmitted by said shaft.
 
2. Device (1) according to claim 1, wherein said elastic elements (50;59) are cylinders or cubes made of natural or synthetic rubber, with diameter comprised between 2 mm and 8 mm and height comprised between 3 mm and 10 mm.
 
3. Device (1) according to claim 1 or 2, wherein said elastic elements (50;59) comprise internal ribs (6) which extend radially and are distributed along the circumference in an equally spaced manner so as to form seats for the collection and release of lotions or creams, so as to stiffen - also in a differentiated manner - said elements and circumscribe the single follicles.
 
4. Device (1) according to claim 3, wherein said ribs differ in primary and secondary, the primary being thicker and more extended towards the centre of the axis of said elastic elements (50;59), the secondary being thinner and shorter.
 
5. Device (1) according to any one of claims 1 to 4, wherein said elastic elements (50;59) have an internal chamber measuring 9.5-500 square mm.
 
6. Device (1) according to any one of claims 1 to 5, wherein said functional part (5) of the head (3) is a disc (55;56;57) with a first face (51) for engagement with said second end (41) of the shaft (4) and a second face (52) to which said elastic elements (50;59) are fixed.
 
7. Device (1) according to claim 6, wherein said disc (55) is elliptical-shaped and said elastic elements (50;59) are distributed on the two halves of the disc divided by said axis (X-X) on two rows (53) by three elements, arranged in a mirror-like fashion with a circle arc.
 
8. Device (1) according to claim 6, wherein said disc (56) is circular-shaped with four elastic elements (50;59) arranged in a cross-like fashion along the circumference of the disc and a central one.
 
9. Device (1) according to claim 6, wherein said disc (57) is circular-shaped with four elastic elements (50;59) arrange in a cross-like fashion so as to leave a central space (58).
 
10. Device (1) according to any one of claims 1 to 9, wherein the components for the command and control of said functional part (5) of the head (3) comprise an electric motor with rechargeable battery capable of carrying out 4,500 to 9,000 rotations/oscillations per minute of said elastic elements (50;59).
 
11. Scalp massage method comprising the steps of:

- providing a device (1) according to any one of claims 1 to 10;

- placing the head of said device on an area to be treated;

- activating the device for 4-6 minutes per day, for 30-60 days, with rotations/oscillations from 4,500 to 24,000 per minute and with an oscillation angle between the axis (X-X) of the shaft (4) for transmitting the movement of the device (1) comprised between 50° and 70° so as to obtain skin laxity, and following the surgery lines and/or the lines of the donor area.


 
12. Method according to claim 11, comprising a step for applying a skin cream or lotion on the scalp and/or on the head of the device before the step of placing the head on the scalp.
 
13. Cosmetic hair transplant method according to any one of the techniques selected from FUT (Follicular Unit Transplantation) virgin and non-virgin scalp, FUE (Follicular Unit Extraction), comprising a scalp massage method according to claim 11 or 12 before or after one of said techniques.
 




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Cited references

REFERENCES CITED IN THE DESCRIPTION



This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

Patent documents cited in the description