DISPOSABLE PROTECTION SYSTEM FOR CAPACITIVE RADIOFREQUENCY DELIVERY DEVICES

Abstract

A disposable device designed to enhance the safety of capacitive radiofrequency therapies is described that is able to prevent risks arising from lesions present on the dielectric surface of the insulated electrode or on the stratum corneum of the skin, as well as risks arising from the use of technologies placed on the market before the certification of non-cytotoxicity of the parts applied to the patient (ISO 10993: 2018) was required, as well as the risks of contamination of parts applied in therapies previously performed on other patients.

Claims

1-10. (canceled)

11. An insulating protective shield made of non-cytotoxic dielectric material and configured and specifically adapted as an interspace between the insulated electrode of a capacitive RF delivery device and the skin surface of a patient to be treated.

12. The protective shield according to claim 11, characterized in that it is disposable.

13. The protective shield according to claim 11, and having a thickness of 0.01-20 mm, preferably 0.1-5 mm.

14. The protective shield according to claim 11, in rigid, semi-rigid or flexible form.

15. The protective shield according to claim 11, hot-molded or injection-molded, milled or molded.

16. The protective shield according to claim 11, made of PVC or polyoxymethylene (POM), polysulfone (PSU), polyphenylsulfone (PPSU), polyetheretherketone (PEEK).

17. The protective shield according to claim 11, in the form of a cover cap specifically adapted to the shape of an insulated electrode of a capacitive RF delivery device.

18. The protective shield according to claim 11, in the form of a film, membrane or dielectric sheet to be applied on the stratum corneum of the patient.

19. A cosmetic method comprising interposing the protective shield according to claim 11 between the insulated electrode of a capacitive RF delivery device and the patient's skin area to be treated.

20. A method for the medical treatment of injured or non-intact skin tissues by applying capacitive RF, said method comprising interposing the protective shield according to claim 11 between the insulated electrode of a capacitive RF delivery device and the patient's skin area to be treated.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1shows schematically the capacitor between an insulated electrode and the skin of a patient.

[0026] FIG. 2shows schematically the risks arising from the use of an insulated electrode 50 which is not perfectly intact.

[0027] FIG. 3shows schematically the risks arising from a non-intact stratum corneum.

[0028] FIG. 4shows the disposable protective shield according to the present invention in two possible embodiments (A) as a cover cap fitted to the shape of the electrode 50 and (B) as an insulating sheet or membrane.

[0029] FIG. 5shows the use of a cover cap 60a according to the present invention to cover the insulated electrode 50 and interposed between the electrode 50 and the skin 53 to restore integrity of the insulator 52 and/or the skin 53.

[0030] FIG. 6shows the use of insulating membrane 60b according to the present invention in the form of an insulating sheet or membrane and interposed between the electrode 50 and the skin 53 to restore the integrity of the insulator 52 and/or the skin 53.

[0031] FIG. 7shows protective caps 60a made of PVC according to what described in the example 1.

[0032] FIG. 8shows a capacitive electrode 50 provided with a protective cap 60a according to the present invention.

[0033] FIG. 9shows (A) an incurable ulcer, (B and C) application of capacitive RF with an electrode coated with a cover cap 60a according to the present invention and (D) the healed ulcer.

DETAILED DESCRIPTION OF THE INVENTION

[0034] The protective insulating shield of the present invention is preferably disposable.

[0035] The protective insulating shield of the present invention may have a thickness of 0.01-20 mm, preferably 0.1-5 mm.

[0036] The protective insulating shield of the present invention preferably has a minimum electrical resistance of at least 500 Ohms.

[0037] The protective shield can be made in rigid, semi-rigid or flexible form, can be hot-molded or injection-molded, milled or molded in general, and can be made of any dielectric material as long as it is non-cytotoxic, i.e. ISO 10993 certified, preferably PVC or polyoxymethylene (POM; Delrin), polysulphone (PSU; Udel), polyphenylsulphone (PPSU; Radel, Tecason), polyetheretherketone (PEEK; Ketron) other non-cytotoxic dielectric material.

[0038] An embodiment of the insulating protective shield of the present invention is in the form of a cover cap 60a (FIG. 4A) specifically fitted to the shape of the insulated electrode 50; in this embodiment, the cover 60a is hot-molded or injection-molded, milled or otherwise shaped to have a three-dimensional conformation such that it completely envelops the surface of the insulated electrode 50 which is intended to contact the patient's skin.

[0039] According to another embodiment, the insulating protective shield may be in the form of a film, membrane or dielectric sheet 60b (FIG. 4B) to be applied to the stratum corneum 53 of the patient, in which case the insulated electrode will be slid over said shield 60b.

[0040] The use of the protective shield of the invention in the application of capacitive RF is compatible with the usual use of electroconductive gel as a gap of electroconductive and lubricating material between the electrode coated with the cap 60a and skin or between the skin coated with the membrane 60b and the electrode.

[0041] In FIGS. 5 and 6 it can be appreciated the function of the protective insulating shield 60a/b capable of restoring the perfect electrical insulation both in case of fracture 55 of the insulator 52 of the insulated electrode 50, and in case of alteration 58 of the stratum corneum 53, preventing the previously described risks of discharge by the insulated electrode to the skin and the concentration of ionic charges inside the skin.

[0042] The insulating shield must be able to interpose itself between the insulated electrode and the patient's skin, thus eliminating both the risks arising from a fracture 55 of the insulating coating 52 and those arising from injuries 58 of the stratum corneum 53, therefore ensuring a perfectly intact and efficient shielding both on the side of the insulated electrode and on the side of the skin, further preventing both the risks related to contamination from previous applications as it is preferably a disposable cover, as well as contact with a potentially cytotoxic shielded electrode, i.e. produced before the new version of ISO 10993.

[0043] The protective shield of the present invention can be used in combination with any capacitive RF delivery device for cosmetic or medical purposes. Preferably, for the purposes of the present invention, the capacitive RF delivery device is as described in WO2007/096009 or in WO2019/049105.

[0044] In one aspect, the present invention relates to a method for cosmetic treatment, sports medicine treatment or medical treatment of skin lesions to facilitate skin regeneration, said method comprising interposing a protective shield as described above between the insulated electrode of a capacitive RF delivery apparatus and the patient's skin area to be treated.

[0045] Preferably, the method of the invention comprises the use of an electrically conductive gel as interspace, in case a protective shield in the form of a cap 60a is used, between the cap and the skin of the patient, in the case a protective shield in the form of a film, membrane or dielectric plane 60b is used, between the electrode and the shield.

[0046] Preferably, the method provides, in case a protective shield in the form of a cap 60a is used, sliding the shielded electrode on the skin of the patient in the area to be treated, in case a protective shield in the form of a film, membrane or dielectric plane 60b is used, being positioned on the skin of the patient in the area to be treated The present invention can be better understood in the light of the following embodiments.

Experimental Part

Example 1Cover Cap of an Insulated Electrode

[0047] The protective cap 60a can be made of transparent, non-cytotoxic PVC, molded using a mould made of aluminium or other material with an opposite double impression, softened at a temperature ranging from 50 to 200 C. The cap produced has a thickness ranging from 0.3 to 0.5 millimetres, such to allow a significant elasticity thereof to ensure optimum adhesion to the electrode (see FIGS. 6 and 7). Otherwise, the cap could be made of Delrin, Udel Polysulfone, Radel, Ketron, Tecason or other non-cytotoxic dielectric material, hollowed out on a lathe or with other mechanical tools or molded. The cap produced has a thickness ranging from 0.3 and 2 millimetres.

Example 2Protective Film

[0048] The protective film 60b can be made of transparent, non-cytotoxic PVC, shaped by means of a mould made of aluminium or other material with an opposite double impression, softened at a temperature ranging from 50 to 200 C. The film produced has a thickness ranging from 0.3 to 0.5 mm, such to allow a significant elasticity and flexibility thereof enabling the film to adapt its shape according to the profile of the skin surface, providing stimulation continuity by the shielded electrode to the skin. Otherwise the film could be made of Delrin, Udel Polysulfone, Radel, Ketron, Tecason or other non-cytotoxic dielectric material, with a thickness ranging from 0.3 to 2 millimetres, shaped with a mould or other mechanical solution or cut with a laser or milling cutter, with such a stiffness as to allow shaping and flattening the skin surface, which will tend to adhere to the film.

Ulcer Treatment

[0049] The cap of the example 1 has proven to be exceptionally effective in the treatment of ulcers, where it has succeeded in allowing the capacitor effect by artificially restoring the electrical insulation which should have been provided by the intact stratum corneum. The results were greater than any other therapy existing in the state of the art, leading to the correct and complete re-epithelisation of a chronic ulcer (see FIG. 8). The solution provided by the cap to the problem of the lack of integrity of the stratum corneum in case of bedsores, ulcers and fistulas makes it possible to extend the regenerative power typical of capacitive radiofrequencies to these specific fields of application, which were precluded so far.

[0050] The ulcer described above had previously undergone all the therapies known in the state of the art without any improvement, but rather continuing to erode, until becoming chronic, for 18 months prior to the treatment carried out with the cap in the example 1.