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WO2025207980A1 - Système de microaiguilletage par rf - Google Patents

Système de microaiguilletage par rf

Info

Publication number
WO2025207980A1
WO2025207980A1 PCT/US2025/021915 US2025021915W WO2025207980A1 WO 2025207980 A1 WO2025207980 A1 WO 2025207980A1 US 2025021915 W US2025021915 W US 2025021915W WO 2025207980 A1 WO2025207980 A1 WO 2025207980A1
Authority
WO
WIPO (PCT)
Prior art keywords
skin
needles
patient
array
dermis layer
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2025/021915
Other languages
English (en)
Inventor
Steve Livneh
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lican Developments Ltd
Original Assignee
Lican Developments Ltd
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 Lican Developments Ltd filed Critical Lican Developments Ltd
Publication of WO2025207980A1 publication Critical patent/WO2025207980A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/06—Electrodes for high-frequency therapy
    • 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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0502—Skin piercing electrodes
    • 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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals
    • A61N1/403—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals for thermotherapy, e.g. hyperthermia
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/0016—Energy applicators arranged in a two- or three dimensional array
    • 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
    • A61B2018/143—Needle multiple needles

Definitions

  • RF microneedling in its current form, relies on an array of needles that is forced to penetrate the dermis layer and provide radio-frequency (RF) electric current to the dermis layer, either in monopolar or bipolar mode. Collagen production follows in the affected tissue post the RF current heating process, which results in an increase in the volume of the dermis layer cells and hence the apparent reduction in visible wrinkles and skin looseness.
  • RF radio-frequency
  • a radio frequency microneedling skin resurfacing system comprising: an assembly including an array of partially insulated needles, each of the needles having an uninsulated tip portion formed at a distal portion thereof and being selectively operable to at least partially penetrate a dermis layer of a patient’s skin; a thermistor system operably associated with the distal portion of at least one of the needles; a source of radio frequency bipolar electrical current operably associated with the array of needles; a vacuum system operable to bring a skin surface of the patient into contact with the array of needles; and a source of dielectric coolant; wherein when the array of needles is caused to penetrate the dermis layer of the patient’ s skin to a first depth, the source of radio frequency bipolar electrical current causes a first series of pulses to the array of needles so as to heat the first depth of the dermis layer of the patient’ s skin; wherein the array of needles is caused to penetrate the dermis
  • the thermistor system is caused to penetrate the dermis layer of the patient’s skin, wherein the thermistor system is selectively operable to transmit temperature data to a control system of the source of radio frequency bipolar electrical current, wherein the transmission of the temperature data to the control system causes the dermis layer of the patient’s skin to be heated to a predetermined temperature.
  • the array of needles is selectively operable to heat the first depth of the dermis layer of the patient’s skin to a first temperature.
  • the array of needles is selectively operable to heat the second depth of the dermis layer of the patient’s skin to a second temperature.
  • Figure 1 illustrates a schematic view of an RF microneedling system, in accordance with the general teachings of the present invention
  • Figure 1A is a section view taken along line A-A as shown in Fig. 1, in accordance with the general teachings of the present invention
  • Figure IB is a detail view of the circled area A as shown in Fig. 1A, in accordance with the general teachings of the present invention.
  • FIG. 2 illustrates the schematic view of the RF microneedling system shown in Fig. 1 with the electrode assembly removed therefrom, in accordance with the general teachings of the present invention
  • FIG. 3 illustrates two exploded views of the electrode assembly shown in Fig. 2, in accordance with the general teachings of the present invention
  • Figure 4 illustrates a sectional view taken along line A-A as shown in Fig. 1 , wherein the electrode assembly is shown being held within a distal end of a right handle shell portion thereof, in accordance with the general teachings of the present invention
  • FIG. 5 illustrates a perspective view of the needle-array printed circuit board (PCB) shown in Fig. 4, in accordance with the general teachings of the present invention
  • Figure 5 A illustrates a sectional view taken along line B-B as shown in Fig. 5, in accordance with the general teachings of the present invention
  • Figure 5B is a detail view of the circled area B as shown in Fig. 5A, in accordance with the general teachings of the present invention.
  • Figure 5C is a detail view of the circled area C as shown in Fig. 5A, in accordance with the general teachings of the present invention.
  • Figure 6 illustrates an exemplary operational system for using the RF microneedling system, in accordance with the general teachings of the present invention.
  • an RF Microneedling System is a system that is designed to induce significant collagen production in the dermis layer cells by inducing heat into the dermis layer with RF alternating current, sometimes popularly referred to as RF energy.
  • the dermis layer cells respond to the heat with major production of collagen that increases the volume of the cells. This increases the volume of the dermis layer.
  • the apparent visual effect is the reduction of wrinkles and improvement in the skin’ s surface due to the actual stretching of the epidermis layer due to the increased volume of the dermis layer underneath it.
  • an electrode assembly is provided and is preferably attached to a handle assembly distally.
  • a treatment cycle is preferably executed each time the electrode is preferably placed on a patient’s skin.
  • a treatment cycle is the process that occurs from the moment that the electrode is pressed against the patient’ s skin and an activation button is preferably pressed once, to the moment when the end-of-cycle is announced by the system. The full description of the treatment cycle is discussed below.
  • the RFMS described and shown herein is preferably comprised of the following main components:
  • An electrode containing an array of insulated (except for the sharp point region) needles that are held and wired in parallel rows.
  • the needles may be forced to enter the patient’s skin or retreat by the push or pull by a servo-motor within the handle.
  • the parallel wiring of the electrode’s needle rows allows for the delivery of bipolar RF current between the needles noninsulated tips. The passage of such RF current causes the heating of the dermis layer cells.
  • the electrode is preferably made of a plastic polymer.
  • the internal moving assembly, containing the needles, is preferably designed and built to assure good sealing performance to maintain the vacuum between the moving internal assembly and the patient’s skin throughout the treatment cycle.
  • One or more of the needles contain a thermistor that is used to sample the dermis layer temperature during the treatment cycle.
  • the needle that contains the thermistor is preferably connected to the electrode’s needle PCB that holds the needles. From the needles PCB, the thermistor wires are connected to the electrode’s engagement PCB assembly that contains the electrode ID chip and the thermistor’s PCB.
  • the needles are preferably retracted to 0.3mm depth, for example, of the dermis layer and a second pulse routine cycle is executed.
  • a more even controlled heating of the dermis layer is preferably achieved with larger collagen production to follow.
  • This feature is not limited to a deep pulse routine first and shallower depth pulse routine secondly, but may be altered by programing preferences of the clinician, such as initiating a shallow depth pulse routine cycle first and then ending with a deep pulse routine.
  • the needles are preferably made of stainless steel.
  • the insulative coating preferably consists of a high dielectric polymer.
  • Other electrode components such as the thermistor, PCBs, wires and chips are made of standard materials used for such components.
  • the RF bipolar generator an electrosurgical unit that provides RF current according to the system’s control algorithm, possibly contained as a PCB inside the generator.
  • Figs. 1A and IB there is illustrated the electrode assembly 12 that is preferably installed securely in the distal portion/structure of the handle assembly 13 and is preferably mechanically engaged with a servo motor 26 shaft 27 and its distal hook-end part 28.
  • the mechanical engagement to the electrode is preferably with the electrode engagement plate’s 29 hook 68.
  • a needle row 30 is shown penetrating a patient’s epidermis layer 31 well into the dermis layer 32, situated above the hypodermis layer 33, that is below the dermis layer.
  • the seal plate 61 houses a needle PCB 64 to which the needle rows 63 are preferably soldered (or otherwise fastened) to in parallel-rows fashion. This enables the RF bipolar electric current to be alternating between the rows in a bipolar fashion; in essence, the current is preferably passing between the uninsulated tips of opposing needle rows such that the dermis layer tissue between the tips is being heated up.
  • the PCB 64 is preferably secured (e.g., glued and sealed) to the seal plate 61 with a motor-engagement plate 29.
  • the engagement plate 29 is preferably made of a rigid polymer and configured to have a hook structure 68 on top of it, such that upon insertion of the electrode assembly 12 into the handle assembly 13 grooves 45, 46, 47 and 48, the hook structure 68 firmly engages with the servo motor shaft-end hook 28 (e.g., see Fig. 2).
  • the engagement PCB assembly 65 is preferably glued to a top recess surface 66 of electrode assembly 12 and it engages, upon insertion, with the handle’s front-contact PCB 49 (shown in Fig. 2).
  • Contact plate 50 is preferably attached to the PCB assembly 65 while maintaining contact with the handle’s front-contact 49 (e.g., see Fig. 2).
  • the contact plate assembly 50 preferably includes contacts (not shown) to the needle rows assembly, the electrode’s ID chip and the thermistor’s chip. Also shown is the electrode’s bottom perforated plate 67, with a corrugated formation, preferably forming troughs to allow the dielectric coolant to flow over the epidermis layer that is being sucked against it by the vacuum generated by the vacuum pump 23.
  • FIG. 4 there is illustrated a cross section view of the electrode assembly 12 being mounted on the distal end of the handle assembly 13.
  • the engagement plate 29, with its integral hook formation 68, is preferably engaged with the servomotor hook-end 28 and thus may be forced in a fore and/or aft direction by the servomotor 26, which is preferably rigidly mounted inside the handle assembly 13.
  • the engagement plate 29 is preferably permanently glued to the seal plate 61 with its seal 62 and it also secures the needle PCB assembly 64 within the seal plate 61.
  • a forward movement of the servomotor shaft 27, with its hook-end 28 will force a distal movement of the engagement plate 29 with the seal plate 61 that houses the needle PCB assembly 64.
  • Fig. 5 there is illustrated the needle plate assembly 64 with the soldered needle rows and the special consideration to the thermistor needle circuitry and wires 81.
  • Fig. 5A there is illustrated a cross section view of the needle row 63 soldered to the needle-array assembly PCB 64.
  • Each needle 70 is preferably coated with an insulative coating 71 except for the very sharp tip region 72 (e.g., the last or distal 0.3-0.8mm portion (e.g., see Fig. 5B)).
  • the thermistor assembly 73 is preferably housed in an insulated needle 74 and secured with a heat permeable adhesive 82 (e.g., see Fig. 5C).
  • the thermistor’s wires 76 are preferably connected to the thermistor’s PCB, which is preferably included in the electrode’s contact plate 50 assembly.
  • Individual needles 70 are preferably soldered to PCB 64 with a solder line 77.
  • Insulated wires 78 preferably conduct the RF current from the RF generator 16 through the handle assembly 13 PCBs 51 and 49, respectively, and through the electrode’s contact plate 50 to the needle PCB assembly 64.
  • the wires 81 preferably carry the thermistor assembly 73 signal to the contact plate 50.
  • Insulated wires (not shown) from the handle assembly’s 13 front PCB 49 preferably carry the signal to the handle’s main PCB 51.
  • FIG. 6 there are illustrated schematic connections for the various components of the RFMS of the present invention, including, but not limited to, the main control and slave control systems of the RFMS of the present invention.
  • treatment-cycle steps are listed in the illustrative algorithm below and they include, in essence and without limitation, the following primary steps:
  • the system is powered ON;
  • pulses stop;
  • Electrode is lifted away and placed onto the next area of the skin to be treated.
  • Thick Skin Routine When treatment cycles are applied to a body area with relatively thicker dermis layer, the Thick Skin pulse routine, effectively a two-stage or more pulse routine, is called for.
  • a Thick Skin algorithm is preferably engaged to execute two stage, or more, treatment cycles.
  • the needles are inserted to 0.7mm depth into the dermis layer first.
  • a pulse routine is then preferably executed.
  • the needles are preferably retracted to 0.3mm depth, for example, of the dermis layer and a second pulse routine cycle is then preferably executed. As such, a more even controlled heating of the dermis layer is preferably achieved.
  • This particular feature is not limited to deep pulse routine first and shallow depth pulse routine secondly, but may be altered by programing preferences of the clinician, such as, for example, initiating a shallow depth pulse routine cycle first and then ending with a deep pulse routine.
  • These variable depth in-sequence treatment cycles depend on, for example:
  • the predetermined dermis layer s thickness typical to skin area to be treated by the selected electrode.
  • a small electrode intended for fine detail treatment such as, for example, above the upper lip, below the eyelids, and/or nasal and forehead skin treatment;
  • a medium size electrode intended for general facial, submental space and/or neck skin treatment
  • a large electrode intended to be used on all non-facial and/or neck skin areas.
  • the system’s algorithm is operable to execute and govern treatment-cycles that optimize the desired heating of the dermis layer with consideration to the patient’ s comfort during treatment.
  • the system of the present invention preferably allows for the selection of three (3) power levels with each type of electrode to “fine-tune” the treatment power level for patients that were pre-treated, for example, with topical anesthetic cream.
  • the cream has limited anesthetic action compared to nerve blocker injections and thus, a lower target temperature, for example, 52-58°C is preferably selected by the algorithm.
  • Each electrode is preferably associated with three (3) power levels for patients that were pre-treated with topical anesthetic cream. The actual power selection depends on the patient’ s preference.
  • the algorithm When treating patients that were pre-treated with nerve-blocker injections, the algorithm preferably executes treatment cycles geared towards achieving a dermis layer temperature of 67°C.
  • the algorithm preferably measures the time-at-temperature of the dermis layer with progress towards achieving a total minimal time at target temperature of (but not limited to), for example, 3 seconds.
  • a total minimal time at target temperature but not limited to, 3 seconds.
  • Cycle treatment electrode parameters (Watts, times, temperature) are selected and set for the selected electrode
  • TempMin 52°C
  • TempMax 58°C
  • TimeGoal 3 seconds.
  • TempMin 65°C
  • TempMax 69°C
  • TimeGoal 3 seconds.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Plastic & Reconstructive Surgery (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne des systèmes de resurfaçage de la peau par microaiguilletage par radiofréquence (RE) comprenant une électrode pourvue d'un réseau d'aiguilles partiellement isolées, les pointes apparentes des aiguilles conduisant un courant électrique à RF bipolaire dans la peau d'un patient, améliorant ainsi la production de collagène qui étire la peau. L'électrode est portée par une poignée d'application, qui se connecte à un générateur de courant à RF. Les cycles de traitement appliqués utilisent le vide pour tirer la peau contre les aiguilles et le liquide de refroidissement diélectrique afin de refroidir l'épiderme. Le réseau d'aiguilles pénètre dans la peau à une profondeur prédéterminée à l'intérieur de la couche de derme, suivie d'une distribution séquentielle d'impulsions de courant bipolaire à RF. Le cycle de traitement est régulé par un algorithme, conçu pour élever la température de la couche du derme pendant une certaine durée. Le cycle de traitement et l'algorithme reposent sur des mesures d'impédance dynamique et des mesures de température par des thermistances afin d'assurer un chauffage régulé optimisé de la couche de derme à une température cible comprise entre 45 et 69 °C.
PCT/US2025/021915 2024-03-27 2025-03-27 Système de microaiguilletage par rf Pending WO2025207980A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463570707P 2024-03-27 2024-03-27
US63/570,707 2024-03-27

Publications (1)

Publication Number Publication Date
WO2025207980A1 true WO2025207980A1 (fr) 2025-10-02

Family

ID=97217671

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/021915 Pending WO2025207980A1 (fr) 2024-03-27 2025-03-27 Système de microaiguilletage par rf

Country Status (1)

Country Link
WO (1) WO2025207980A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090105706A1 (en) * 2006-07-05 2009-04-23 Bovie Medical Corporation Apparatus and method for skin tightening and corrective forming
US20120158100A1 (en) * 2010-06-21 2012-06-21 Kevin Schomacker Driving Microneedle Arrays into Skin and Delivering RF Energy
US20140194789A1 (en) * 2011-07-26 2014-07-10 Lutronic Corporation Treatment apparatus using high frequency waves and method for controlling same
US20160228178A1 (en) * 2014-12-19 2016-08-11 Chongqing Derma Optic&Electronic Technique Co., Ltd. Radio frequency treatment apparatus
WO2023121325A1 (fr) * 2021-12-22 2023-06-29 서석배 Appareil et procédé d'application de courants monopolaires et bipolaires par profondeur de peau pendant une insertion d'aiguille

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090105706A1 (en) * 2006-07-05 2009-04-23 Bovie Medical Corporation Apparatus and method for skin tightening and corrective forming
US20120158100A1 (en) * 2010-06-21 2012-06-21 Kevin Schomacker Driving Microneedle Arrays into Skin and Delivering RF Energy
US20140194789A1 (en) * 2011-07-26 2014-07-10 Lutronic Corporation Treatment apparatus using high frequency waves and method for controlling same
US20160228178A1 (en) * 2014-12-19 2016-08-11 Chongqing Derma Optic&Electronic Technique Co., Ltd. Radio frequency treatment apparatus
WO2023121325A1 (fr) * 2021-12-22 2023-06-29 서석배 Appareil et procédé d'application de courants monopolaires et bipolaires par profondeur de peau pendant une insertion d'aiguille

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