WO2010067392A2 - Appareil de médecine esthétique - Google Patents

Appareil de médecine esthétique Download PDF

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Publication number
WO2010067392A2
WO2010067392A2 PCT/IT2008/000771 IT2008000771W WO2010067392A2 WO 2010067392 A2 WO2010067392 A2 WO 2010067392A2 IT 2008000771 W IT2008000771 W IT 2008000771W WO 2010067392 A2 WO2010067392 A2 WO 2010067392A2
Authority
WO
WIPO (PCT)
Prior art keywords
skin
needle
patient
handpiece
electric signal
Prior art date
Application number
PCT/IT2008/000771
Other languages
English (en)
Other versions
WO2010067392A3 (fr
Inventor
Valerio MATANÒ
Egidio Tranfaglia
Original Assignee
Promoitalia Group S.P.A.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Promoitalia Group S.P.A. filed Critical Promoitalia Group S.P.A.
Priority to PCT/IT2008/000771 priority Critical patent/WO2010067392A2/fr
Publication of WO2010067392A2 publication Critical patent/WO2010067392A2/fr
Publication of WO2010067392A3 publication Critical patent/WO2010067392A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/328—Applying electric currents by contact electrodes alternating or intermittent currents for improving the appearance of the skin, e.g. facial toning or wrinkle treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1425—Needle

Definitions

  • the present invention refers to an aesthetic medicine apparatus allowing the concomitant application of minimally ablative radiofrequency (RF) and resorbable filling solutions, for the treatment of wrinkles and the remodeling of face contours and skin depressions or scars. History of the technology
  • RF radiofrequency
  • Filling solutions also referred to a ⁇ "fillers” are injected in the superficial derm with a very thin needle in order to fill wrinkles, depressions, scars, pronounced nasogenial furrows, or to increase the volume of lips, chin and cheekbones.
  • Hyaluronic acid is among the most widespread fillers.
  • Hyaluronic acid is a basic component of the derm, but tends to be gradually resorbed with ageing. Its properties give hydration to skin, thanks to its hydrophily, as well as elasticity and softness. This constant and considerable decrease is among the main causes of skin ageing; therefore, repeated injections of hyaluronic acid, besides causing the desired filling effect, allow reactivating mature skins by stimulating their cell functionality, lending to skin its lost compactness and brightness.
  • Hyaluronic acid or other basic components for resorbable fillers may be treated with vitamins and coenzymes in order to optimize skin physiology and carry out the so- called "Bio-Revitalization", i.e. a medical treatment integrating in the derm substances that our organism is no longer able to produce in an adequate form (hyaluronic acid, vitamins, minerals, coenzymes, etc).
  • resorbable fillers beside hyaluronic acid, there may be mentioned those based on polytactic acid, bovine collagen, autologous collagen, polyacrylamide, agarose gel, collagen joined to granules (polymethylmethacrylates), vitamins, amino acids, coenzymes, minerals and nucleic acids.
  • Radiofrequency RF
  • ablative radiofrequency ablative radiofrequency
  • non-ablative radiofrequency causes a rise in derm temperature, with the entailed denaturing of part of the pre-existing elastic fibers and collagen and, as a side effect of repair processes, fibroblast stimulation with production of new collagen.
  • Derm remodeling therefore causes the improvement of superficial and deep wrinkles, the compacting of the skin and the increase of its turgidity, lending a wholly natural "lifting" effect to the skin.
  • the end effect of this process will be that of a taut skin, having a more tonic appearance.
  • ablative radiofrequency causes the destruction of a limited volume of tissue in a controlled and reproducible manner.
  • Ablative RF with respect to non- ablative RF, is more invasive but allows a more targeted and focalized treatment.
  • the use of each of said techniques entails several evident drawbacks.
  • the filling effect is variable and depends on the skin type, the facial mimicry, the rate at which the body consumes its own collagen, and the amount and quality of filler used.
  • the aesthetic result is not permanent, owing to the progressive resorption of the substance, requiring periodic reintervention. Such resorption depends on the process of degradation and acceleration of hyaluronic acid and other basic components of the filling solutions, in turn subordinated to the specific patient's lifestyle: smoking habit, environmental pollution, alimentary habits.
  • solutions containing hyaluronic acid with vitamins/amino acids and other revitalizing solutions often consist in aqueous solutions which easily tend to shift, be it for poor preparation of the treated anatomical region or because contact with treated zones is not avoided in the post-treatment hours which follow, or lastly for an excessive contraction of the musculature to which the treated region is subjected.
  • the filler tends to be subjected to unceasing facial motions, and therefore it does not stay still in the same spot.
  • Object of the present invention is to overcome the drawbacks mentioned hereto with reference to the known art, by providing an aesthetic medicine device as substantially described in claim 1 , further providing an aesthetic medicine apparatus as substantially described in claim 10, and finally providing an aesthetic medicine apparatus as substantially described in claim 13.
  • the apparatus subject-matter of the present invention is configured for subjecting the patient to a concomitant application of RF and filler for the treatment of wrinkles or other blemishes or signs of skin sagging.
  • the wrinkle furrow is filled with hyaluronic acid (or other filling solutions) and the fibrotic channel produced by RF is such as to form a sort of shell, or capsule, which will protect the injected solution.
  • the latter in fact, deposited in said resistant and microfibrotic capsule, tends to be more protected, less attackable by enzymatic degradation systems, less soluble, and therefore it will tend to last longer.
  • the capsule reduces contraction of muscles that have induced the wrinkle and offers a certain resistance also to mechanical stresses. In fact, by acting on subcutaneous muscles, said capsule reduces their degree of contractility and power, and therefore also the duration of the tightening effect. All this sensibly reduces the chance of a displacement of the filling solution, with the entailed greater duration of the injected implant.
  • the apparatus subject- matter of the present invention beside offering the option of manually setting parameters such as, e.g., frequency, intensity and pulses of the generated RF, is preset with two automatic programs for the combined RF/injectable solution treatment, of which 1 program for filler injection and 1 program for revitalizing solution injection.
  • the apparatus is prearranged with about 28 programs preset for RF application only, since it could be used even only with said technology, as it will be illustrated in detail hereinafter.
  • Cycle 3 cycles (to perform a serial-point technique) Frequency: 1050 KHz
  • Another advantage is the decrease of some side effects deriving from the application of a single RF, such as, e.g., edema, reddening, erythema (above all periorbital and of the prolabium), resulting scars, sensation of heat mingled with paresthesia of the treated zone.
  • a single RF such as, e.g., edema, reddening, erythema (above all periorbital and of the prolabium), resulting scars, sensation of heat mingled with paresthesia of the treated zone.
  • parameters are set on the basis of the specific area and layer to be treated.
  • Frequency, Cycle, Pulse and Pause are preset on the basis of the specific indication; the operator merely needs to adjust RF emission power (Power).
  • This programs enable to perform a very fine ablation of tissue and, concomitantly, a thermal stimulation capable of triggering a biological process leading to collagen biosynthesis for:
  • - treatment of linear-patterned skin lesions such as striae distensae (commonly known as "stretch marks”); - wrinkle treatment (glabellar wrinkles, nasolabial folds, periocular folds, puppet line, forehead, neck and decollete wrinkles, lip contour, vertical lifting);
  • o master card converts the 16 V AC of the transformer to 12 V AC, so as to guarantee the apparatus functionality and safety even with voltages higher or lower than standard network voltage, generates voltage for display backlighting
  • o CPU card manages display, receives commands from keyboard, hosts buzzers for acoustic signaling
  • o actuator card generates working frequency, adjusts output power volume, receives commands from CPU card.
  • a microcontroller a power stage, which ends on a transformer with electronics-side primary and secondary, with in series a patient-side capacitor, totally separated therebetween.
  • the actuator card microcontroller generates working frequency and adjusts power output; in case of microcontroller failure, there being no generating frequency, there is no frequency at the output. This safeguards from undesired straying off the radiofrequency.
  • the transformer with the secondary and, in series, the condenser does not enable the neuromuscular stimulation option.
  • the power supply transformer was inserted to guarantee electrical safety and resistance to short-circuits. Moreover, a microprocessor was inserted so that the amount of power delivered may not exceed the threshold value of 36 W, both in standard use and under first failure conditions; control occurs with a 20-step arrangement, therefore in case of failure of the same there is no generating frequency, and as a consequence there is no radiofrequency at the output.
  • Figures 1 and 2 depict in a perspective view a device according to the present invention
  • Figure 3 depicts an assembly according to the present invention, comprising the device of Figures 1 and 2; and Figures 4 and 5 illustrate in a perspective view an apparatus according to the present invention.
  • the device 1 comprises a needle 2, made of an electrically conductive material, and means 3 for transmitting an electric signal, connected to the needle 2.
  • the needle 2 is made of electrically conductive material so as to be electrified by an electric signal transmitted by the means 3, and that therefore flows thereinside.
  • the transmitting means 3 is of wire type.
  • such wire transmitting means 3 make a contact connection by welding on the needle 2, but it will be appreciated that also reversible-type connections could be used.
  • the device 1 subject-matter of the present invention further comprises a bottle 4, containing filling solution to be injected via the needle 2 in a patient's skin. Furthermore, the needle 2 is integral to means 5 for reversible connection with the bottle 4.
  • the bottle used in the preferred embodiment shown here is a standard syringe 4.
  • the needle 2 has a side surface 21 and a terminal end wall 22.
  • the needle 2 has an insulating coating, preferably made of Teflon, substantially arranged on the side surface 21.
  • the insulating coating arranged on the side surface leaves uncovered the terminal end wall 22, so as to concentrate the flow of the electric signal through said wall 22, thereby avoiding signal dispersion via the side surface of the needle.
  • the wire means 3 for transmitting the electric signal is connectible to an external apparatus (not shown in Figure) by a first monopolar-type terminal jack 6.
  • the circuit-making wire means of monopolar type, comprises a plate 12 apt to be positioned on a patient's skin.
  • the circuit-making wire means 11 as being of monopolar type, have a second monopolar jack 13, removably connectible to an external generator of RF electric signal (not shown in Figure).
  • a plate is positioned on the patient substantially in correspondence of a zone in which injection of filling solution takes place by means of the electrified needle 2. Therefore, such circuit-making means 11 is necessary to set up a made electric circuit in which the electric signal may transit, in order not to disperse on the patient's skin surface, thereby causing undesired effects.
  • FIG. 4 it is depicted an aesthetic medicine apparatus 100 for the treatment - of wrinkles and/or other skin blemishes according to the present invention.
  • the apparatus 100 comprises an RF electric signal generator 101 , and an handpiece (not depicted in Figure) electrically connected to said generator in a removable and interchangeable manner.
  • the apparatus 100 comprises man - machine interface means 300, in order to set parameters (manually or automatically according to the above-described preset programs) for its use.
  • Such interface means comprises, by way of example and not for limitative purposes, an alphanumeric keyboard and a display.
  • the handpiece connected to the generator 101 could be, alternatively and depending on the required typology of intervention to be performed, the above-described assembly. Therefore, in order to make said removable connection with the assembly, the generator 101 has a pair of monopolar-type female plugs, in which there will respectively be inserted the first jack of the device and the second jack of the circuit- making means, detailed above.
  • the assembly could be connected to the apparatus 100 also in correspondence of a bipolar-type female plug, by interposing between the two monopolar male jacks of the assembly and the bipolar female plug of the apparatus 100 an adapter (not depicted), comprising a bipolar male jack, apt to be inserted in the bipolar female plug of the apparatus, connected to two monopolar-type female plugs apt to receive each a respective monopolar jack of the assembly.
  • the generator 101 produces an RF current signal that crosses the wire transmitting means of the device and flows through the needle.
  • the current signal thanks to the insulating coating, gets without dispersion on the patient's skin from the needle end in order to create a very fine ablation of cutaneous tissue, concomitantly to the injection of a filling solution, always by means of the needle of the device.
  • the generator 101 comprises thereinside storage batteries (not shown in Figure) required for its power-supplying.
  • the apparatus 100 further comprises an apparatus 200 for recharging said batteries, removably connected with the generator 101.
  • said RF signal generator has one or more bipolar-type female plugs, in order to connect, always in a removable and interchangeable manner, various types of handpieces working with both a bipolar and a monopolar technology.
  • the monopolar technique adopted e.g. for the assembly, it is set up an electric current regimen between two electrodes that are placed into contact with the patient, so that current crossing the skin be such as to cause the desired effects.
  • the needle of the device and the circuit-making plate perform said electrode function.
  • bipolar technique it is used a single handpiece having the two electrodes positioned on two distal ends of the handpiece itself. In this case, current flow takes place from one end to the other one, exploiting as electrical bridge the amount of treated tissue, which will be appreciated to be extremely less than the monopolar case. It is understood that the contrivances and the technical knowledge needed in order to manufacture a bipolar- or monopolar-type handpiece, or a female plug or a male jack, of bipolar or monopolar type, are deemed to be within the reach of a person skilled in the art and therefore will not be further detailed hereinafter.
  • bipolar-type handpieces which can be connected to the signal generator in an interchangeable manner.
  • a bipolar handpiece 110 comprising an electrode having a substantially needle-like shape
  • an unipolar handpiece 120 (behaving as a radial source of electric signal and for which there is no circuit making), comprising an electrode having a terminal element having a substantially spherical shape, or a handpiece 130 having an electrode having a substantially slot-like shape.
  • the present invention has been hereto described with reference to a preferred embodiment thereof. It is understood that other embodiments might exist, all falling within the concept of the same invention, and all comprised within the protective scope of the claims hereinafter.

Abstract

La présente invention concerne un appareil de médecine esthétique pour l'application simultanée de radiofréquences (RF) minimalement ablatives et de solutions de remplissage résorbables, destiné au traitement de rides ou d'autres signes du vieillissement de la peau. L'appareil est configuré pour soumettre un patient à une application simultanée de radiofréquences et d'une charge. Ainsi, il effectue simultanément une ablation RF très fine du tissu cutané, une destruction contrôlée et reproductible d'un certain volume de tissu, et une stimulation thermique susceptible de créer un canal fibrotique dans lequel une charge est déposée de manière stable.
PCT/IT2008/000771 2008-12-12 2008-12-12 Appareil de médecine esthétique WO2010067392A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IT2008/000771 WO2010067392A2 (fr) 2008-12-12 2008-12-12 Appareil de médecine esthétique

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IT2008/000771 WO2010067392A2 (fr) 2008-12-12 2008-12-12 Appareil de médecine esthétique

Publications (2)

Publication Number Publication Date
WO2010067392A2 true WO2010067392A2 (fr) 2010-06-17
WO2010067392A3 WO2010067392A3 (fr) 2010-11-11

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2732849A4 (fr) * 2011-08-26 2015-08-05 Amorepacific Corp Appareil cosmétique utilisant des ondes à haute fréquence
CN109419616A (zh) * 2017-08-29 2019-03-05 松下知识产权经营株式会社 美容器具

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050177202A1 (en) * 2004-02-09 2005-08-11 Classen Ashley M. Method and apparatus for veterinary RF pain management
WO2007030415A2 (fr) * 2005-09-07 2007-03-15 The Foundry, Inc. Appareil et procede permettant de desintegrer des structures sous-cutanees
WO2007034522A1 (fr) * 2005-09-23 2007-03-29 Promoitalia Group Spa Appareil permettant l'application simultanee d'une carboxytherapie et d'une mesotherapie
US20080161747A1 (en) * 2006-12-20 2008-07-03 Justin Lee Electrically conductive microneedle roller

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050177202A1 (en) * 2004-02-09 2005-08-11 Classen Ashley M. Method and apparatus for veterinary RF pain management
WO2007030415A2 (fr) * 2005-09-07 2007-03-15 The Foundry, Inc. Appareil et procede permettant de desintegrer des structures sous-cutanees
WO2007034522A1 (fr) * 2005-09-23 2007-03-29 Promoitalia Group Spa Appareil permettant l'application simultanee d'une carboxytherapie et d'une mesotherapie
US20080161747A1 (en) * 2006-12-20 2008-07-03 Justin Lee Electrically conductive microneedle roller

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2732849A4 (fr) * 2011-08-26 2015-08-05 Amorepacific Corp Appareil cosmétique utilisant des ondes à haute fréquence
CN109419616A (zh) * 2017-08-29 2019-03-05 松下知识产权经营株式会社 美容器具
CN109419616B (zh) * 2017-08-29 2022-08-16 松下知识产权经营株式会社 美容器具

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