RF microneedling system

Abstract

Radio-frequency (RE) microneedling skin resurfacing systems are described including an electrode with an array of partially insulated needles, where the needles' exposed tips conduct bipolar RF electric current into a patient's skin, thus enhancing collagen production that stretches the skin. The electrode is carried by an application handle, which connects to an RF current generator. The applied treatment cycles utilize vacuum to pull the skin against the needles and dielectric coolant to cool the epidermis. The needles' array penetrates the skin to a pre-determined depth inside the dermis layer, followed by a sequential delivery of RF bipolar current pulses. The treatment cycle is controlled by an algorithm, designed to raise the dermis layer temperature for a certain duration. The treatment cycle and algorithm rely on dynamic impedance measurements and temperature measurements by thermistors to assure optimized controlled heating of the dermis layer to a target temperature between 45 and 69°C.

Description

[0001] RF MICRONEEDLING SYSTEM

[0002] CROSS-REFERENCE TO RELATED APPLICATION

[0003] The instant application claims priority to U.S. Provisional Patent Application Serial No. 63 / 570,707, filed March 27, 2024, pending, the entire specification of which is expressly incorporated herein by reference.

[0004] BACKGROUND OF THE INVENTION

[0005] Human skin generally includes three distinct layers, i.e., the epidermis (i.e., the top layer), the dermis (i.e., the middle layer) and the hypodermis (i.e., the bottom or fatty layer). As humans age, the amount of collagen, especially in the dermis layer, tends to decrease significantly, thus resulting in visible wrinkles and skin looseness.

[0006] 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.

[0007] The electrode that carries the needles is typically attached to an application handle which connects to an RF generator that supplies pulses of RF electric current at low to medium power settings (e.g., typically 5-5OW). Some of the current systems are controlled by algorithms and include some forms of impedance and temperature measurements as indications to the treatmentcycle progression. Most systems utilize bipolar energy, though some rely on monopolar energy. The majority of systems are offered with partially insulated needles to reduce damage to the epidermis layer.

[0008] When a patient is being treated by a clinician, in most cases, some form of anesthetic is applied prior to the treatment, either as a topical anesthetic cream or as a nerve blocker injection. The electrode is attached to the treated skin with the help of vacuum and the needles penetrate the epidermis layer and into the dermis layer. In some instance, a coolant, such as a dielectric coolant, is forced on top of the epidermis through the electrode’s bottom troughs. Pulses of RF current are emitted into the dermis layer, causing the temperature rise. Once the target temperature has been cumulatively reached for a desired duration, the treatment cycle stops and the electrode is then placed on the next treatment spot and the treatment cycle resumes.

[0009] Accordingly, there exists a need for new and improved RF microneedling systems, and methods of use thereof, that overcome the aforementioned deficiencies in the prior art. SUMMARY OF THE INVENTION

[0010] The present invention described herein achieves advancements in RF microneedling technology by introducing advanced electrodes and system components that provide vacuum, cooling and dynamic process controls, including real-time measurement of impedance and actual temperature of the dermis layer as indications of the progress and the end of a treatment cycle.

[0011] In accordance with the general teachings of the present invention, new and improved RF microneedling skin resurfacing systems, and methods of use thereof, are provided.

[0012] More specifically, the present invention provides an RF microneedling skin resurfacing system, comprised of an electrode with an array of insulated needles, where the needles exposed tips conduct bipolar RF electric current into the patient’s skin, thus enhancing collagen production that stretches the skin. The electrode is preferably carried by the application handle, which connects to an RF current generator. The applied treatment cycles utilize vacuum to pull the skin against the needles and dielectric coolant to cool the epidermis layer. The needles’ array penetrates the skin to a pre-determined depth inside the dermis layer, followed by a sequential delivery of RF bipolar current pulses. The treatment cycle is preferably controlled by an algorithm, designed to raise the dermis layer temperature for a certain duration. The treatment cycle and algorithm rely on dynamic impedance measurement and temperature measurements by thermistors to assure optimized controlled heating of the dermis layer to a target temperature between 45 and 69°C. Meanwhile, the epidermis layer is preferably kept below 41°C by applying the coolant. The system herein with its algorithm provides treatment parameter flexibilities according to the patient’s individual discomfort tolerance and type of anesthetic used.

[0013] In accordance with a first embodiment of the present invention, a radio frequency microneedling skin resurfacing system is provided, 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 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 coolant; wherein when the array of needles is caused to penetrate the dermis layer of the patient’ s skin, the source of radio frequency bipolar electrical current causes a series of pulses to the array of needles so as to heat the dermis layer of the patient’ s skin; wherein when the array of needles heats the dermis layer of the patient’s skin, the source of coolant causes a flow of coolant onto an epidermis layer of the patient’s skin.

[0014] In accordance with an aspect of the first embodiment of the present invention, a thermistor system is operably associated with the distal portion of at least one of the needles.

[0015] In accordance with an aspect of the first embodiment of the present invention, 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.

[0016] In accordance with an aspect of the first embodiment of the present invention, the array of needles penetrates the dermis layer of the patient’s skin to a first depth, wherein 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.

[0017] In accordance with an aspect of the first embodiment of the present invention, the array of needles penetrates the dermis layer of the patient’s skin to a second depth, wherein the source of radio frequency bipolar electrical current causes a second series of pulses to the array of needles so as to heat the second depth of the dermis layer of the patient’ s skin.

[0018] In accordance with an aspect of the first embodiment of the present invention, 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.

[0019] In accordance with an aspect of the first embodiment of the present invention, 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.

[0020] In accordance with a second first embodiment of the present invention, a radio frequency microneedling skin resurfacing system is provided, 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 a 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, the source of radio frequency bipolar electrical current causes a series of pulses to the array of needles so as to heat the dermis layer of the patient’ s skin; wherein when the array of needles heats the dermis layer of the patient’s skin, the source of dielectric coolant causes a flow of dielectric coolant onto an epidermis layer of the patient’s skin.

[0021] In accordance with an aspect of the second embodiment of the present invention, 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.

[0022] In accordance with an aspect of the second embodiment of the present invention, the array of needles penetrates the dermis layer of the patient’s skin to a first depth, wherein 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.

[0023] In accordance with an aspect of the second embodiment of the present invention, the array of needles penetrates the dermis layer of the patient’s skin to a second depth, wherein the source of radio frequency bipolar electrical current causes a second series of pulses to the array of needles so as to heat the second depth of the dermis layer of the patient’ s skin.

[0024] In accordance with an aspect of the second embodiment of the present invention, 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.

[0025] In accordance with an aspect of the second embodiment of the present invention, 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.

[0026] In accordance with a third embodiment of the present invention, a radio frequency microneedling skin resurfacing system is provided, 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 layer of the patient’ s skin to a second depth, the source of radio frequency bipolar electrical current causes a second series of pulses to the array of needles so as to heat the second depth of the dermis layer of the patient’s skin; wherein when the array of needles heats either of the first and second depths of the dermis layer of the patient’s skin, the source of dielectric coolant causes a flow of dielectric coolant onto an epidermis layer of the patient’s skin.

[0027] In accordance with an aspect of the third embodiment of the present invention, 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.

[0028] In accordance with an aspect of the third embodiment of the present invention, 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.

[0029] In accordance with an aspect of the third embodiment of the present invention, 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.

[0030] Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the present invention, are intended for purposed of illustration only and are not intended to limit the scope of the present invention.

[0031] BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Other advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:

[0033] Figure 1 illustrates a schematic view of an RF microneedling system, in accordance with the general teachings of the present invention;

[0034] 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;

[0035] 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;

[0036] Figure 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;

[0037] Figure 3 illustrates two exploded views of the electrode assembly shown in Fig. 2, in accordance with the general teachings of the present invention;

[0038] 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;

[0039] Figure 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;

[0040] 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;

[0041] 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;

[0042] 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; and

[0043] Figure 6 illustrates an exemplary operational system for using the RF microneedling system, in accordance with the general teachings of the present invention.

[0044] The same reference numerals refer to the same parts throughout the various Figures.

[0045] DETAILED DESCRIPTION OF THE INVENTION

[0046] The following description of the preferred embodiments) is merely exemplary in nature and is in no way intended to limit the present invention, or uses. The following legend is provided for the various components of the present invention. It should be understood that this is not an exhaustive list, but is intended only to set forth the primary components of the present invention, and that one or more supplemental and / or ancillary components that are well known in the art may have been omitted therefrom.

[0047] 11 - RF Microneedling System

[0048] 12 - Electrode assembly

[0049] 13 - Handle assembly

[0050] 14 - Activation button

[0051] 15 - Power cable

[0052] 16 - RF bipolar generator

[0053] 17 - Coolant nipple

[0054] 18 - Coolant tube

[0055] 19 - Coolant pump

[0056] 20 - Coolant suction tube

[0057] 21 - Coolant bottle

[0058] 22 - Vacuum nipple

[0059] 23 - Vacuum pump

[0060] 24 - Vacuum tube

[0061] 25 - Waste coolant bottle

[0062] 26 - Servo motor

[0063] 27 - Servo motor shaft

[0064] 28 - Shaft hook-end

[0065] 29 - Electrode’s engagement plate

[0066] 30 - Needle row

[0067] 31 - Epidermis layer

[0068] 32 - Dermis layer

[0069] 33 - Hypodermis layer

[0070] 34 - Waste coolant tube

[0071] 35 - Monitor

[0072] 40 - Handle right shell

[0073] 41 - Handle left shell

[0074] 42 - Lock slider

[0075] 43 - Lock spring

[0076] 44 - Slider knob 45 - Vertical groove right handle

[0077] 46 - Horizontal groove right handle

[0078] 47 - Vertical groove left handle

[0079] 48 - Horizontal groove left handle

[0080] 49 - Handle’s front contact PCB

[0081] 50 - Electrode’s contact thermistor and electrode’s ID chip assembly

[0082] 51 - Handle’s main PCB

[0083] 52 - Boss

[0084] 53- Electrode’s flange

[0085] 60 - Electrode’s body

[0086] 61 - Seal plate

[0087] 62 - O-ring seal

[0088] 63 - Needle rows

[0089] 64 - Needles PCB

[0090] 65 - Electrode’s engagement PCB assembly

[0091] 66 - Top electrode recess

[0092] 67 - Electrode’s bottom perforated plate

[0093] 68 - Engagement plate hook

[0094] 70 - Needle

[0095] 71 - Needle’s insulative coating

[0096] 72 - Needle’s uninsulated tip region

[0097] 73 - Thermistor assembly

[0098] 74 - Thermistor’s needle

[0099] 75 - Thermistor tip

[0100] 76 - Thermistor’s wires assembly

[0101] 77 - Solder line

[0102] 78 - PCB 54 connecting wires

[0103] 79 - Seal groove

[0104] 80 - Connecting wires

[0105] 81 - Thermistor wires

[0106] 82 - Heat permeable adhesive

[0107] As explained above in the background of the invention section, an RF Microneedling System (RFMS) 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.

[0108] Referring to the Figures generally, and in accordance with the general teachings of the present invention, 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.

[0109] In general, the RFMS described and shown herein is preferably comprised of the following main components:

[0110] 1. 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.

[0111] The electrode is preferably used to deliver other highly valuable functions that assist in the controlled heating of the dermis layer. Those functions are the application of vacuum that “sucks” the skin against the outcoming needles (i.e., the needles protrude from the electrode’s bottom perforated plate) and thus aids in the complete penetration of the needles into the skin. At the same time, dielectric coolant is preferably being delivered. The passage of dielectric coolant over the epidermis layer keeps the skin’s external layer, i.e., the epidermis layer, cool and thus reduces the possibility of burns to the epidermis layer. An important benefit here is the reduction of post-treatment redness and quicker visual recovery.

[0112] 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.

[0113] 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.

[0114] Another valuable advancement that is included in the present invention herein is the introduction of a Thick Skin Routine algorithm. When treatment cycles are applied to a skin area with a thicker dermis layer than in certain facial or neck areas, a two-stage (or more) pulse routine is called for. It should be appreciated that reference to a two-stage pulse routine is exemplary in nature, and that multiple (i.e., more than two) pulse routines may be practiced with the system of the present invention. Once a “Thick Skin” electrode is identified by the system, a Thick Skin algorithm is preferably engaged to execute a two stage (or more) treatment cycle. In such cases, as a non-limiting example, the needles are inserted to 0.7mm depth of the dermis layer first. A pulse routine is preferably executed. At the end of the pulse routine, the needles are preferably retracted to 0.3mm depth, for example, of the dermis layer and a second pulse routine cycle is executed. As such, a more even controlled heating of the dermis layer is preferably achieved with larger collagen production to follow.

[0115] 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.

[0116] 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.

[0117] 2. The handle, designed and made to be ergonomically comfortable to the clinician, preferably connects to the electrode, providing the passage of RF current and sensory wires’ connections to the electrode from the RF generator through the handle’s main PCB. The handle is preferably made of a plastic polymer to assure electric insulation.

[0118] 3. 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.

[0119] 4. A display / monitor, providing process and components information to the clinician (and the patient as well) programming input selections.

[0120] 5. Vacuum and coolant pumps with the necessary tubing and wiring with bottles for fresh dielectric coolant and the collection of used (i.e., waste) coolant.

[0121] 6. The system cart (not shown) on which all components are loaded / installed and connected.

[0122] Still referring to the Figures generally, and in accordance with the general teachings of the present invention, Fig. 1 illustrates an RF microneedling system 11 preferably comprised of a disposable electrode assembly 12 being attached to a reusable handle assembly 13 (shown as being transparent for purposes of illustration and clarity) with an activation button 14. Also shown is the handle’s main PCB 51 and power cable 15 connected to an RF bipolar generator 16. A RF generator 16 is preferably connected to a monitor 35 that preferably displays the system and cycle treatment information. The electrode assembly 12, preferably having a coolant nipple 17, is preferably connected a tube 18 (it should be noted that all tubes, wires and cables are shown schematically as lines) that connects to a coolant pump 19. Tube 20 preferably connects to a coolant pump 19 to a coolant bottle 21. A vacuum nipple 22 preferably connects to a vacuum pump 23 via a tube 24. Tube 34 preferably connects the vacuum pump 23 to a wastecoolant bottle 25.

[0123] Referring specifically to 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.

[0124] Referring specifically to Fig. 2 (again shown as being transparent for purposes of illustration and clarity), there is illustrated a right handle shell 40 and a left handle shell 41, enclosing lock-slider 42, that is normally pushed distally by a spring 43. The lock slider 42 may be forced proximally by pressing slider-knob 44 rearwards, thus allowing the insertion or detachment of the electrode assembly 12. Both the right shell 40 and the left shell 41 preferably include grooved sections, i.e., 45, is preferably a vertical groove and 46 is preferably a horizontal groove of shell 40 (both are mirror symmetrical to identical grooves 47 and 48 on left handle shell 41) configured to accept the electrode assembly 12 flange 53 (e.g., as illustrated in Fig. 3 as well) into position, i.e., to engage with the servo motor’s 26 shaft 27 and hook-end 28 and at the same time being held and secured by lock-slider 42.

[0125] Also illustrated is a front contact PCB 49 that preferably connects with the electrode assembly 12 top’s contact plate assembly 50. The assembly 50 preferably includes contacts to the electrode’s needle rows, the thermistor’s chip and the electrode’s ID chip (e.g., see Fig. 3). The front contact PCB 49 preferably connects with the main handle’s PCB 51, behind activation button 14. It should be noted that a more complete illustration of the various wires and cables are shown schematically in Fig. 6. Bosses 52 are common molded formations allowing the fastening of both handle shells 40 and 41 with conventional fasteners, such as but not limited to screws (not shown). Referring specifically to Fig. 3, there is illustrated two exploded views (showing a front view and a rear view) of the electrode assembly 12, having a body 60 and a seal plate 61 with an O-ring seal 62. 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.

[0126] The seal plate 61 preferably carries a seal 62 (e.g., an O-ring type) that is preferably placed in a circumferential seal groove 79. This seal preferably seals the circumference of the seal plate 61 during movements, while the inside of the plate 61 is preferably being sealed with the needle PCB assembly 64 and the engagement plate 29. These elements are preferably glued and sealed into their respective positions within and on top of the seal plate 61 .

[0127] Referring specifically to 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. Thus, as an example, 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. This movement introduces the needles’ sharp ends through the electrode bottom perforated plate 67 and into the patient’s skin. The electrode is preferably held secured by the slider lock 42 that is preferably pushed distally by the spring 43. The electrode assembly’s flange 53, in this cross-sectional view, is shown as being held in the groove 46.

[0128] Referring specifically to 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.

[0129] Referring specifically to 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.

[0130] 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.

[0131] Each electrode assembly 12 preferably has one or more thermistor assemblies as shown here. This new and unique feature of the present invention enables the system to essentially “read” the patient’s dermis layer temperature during the treatment cycle and adjust the progress and end of the treatment cycle based on the dynamic temperature reading by the thermistor(s) and its (their) related hardware and / or wiring.

[0132] Referring specifically to 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.

[0133] The RFMS of the present invention is preferably a system that is preferably designed to execute treatment cycles on the patient’s skin by heating up the dermis layer, ideally, to about 67°C, while providing cooling to the epidermis layer and by applying vacuum to assist the needles’ penetration. However, beneficial structural improvements to the dermis layers were found to occur following controlled heat application as low as 45°C and up to the low 70°Cs. The treatment cycle is preferably an automatic cycle, that is preferably algorithm governed, and that is preferably launched by pressing the activation button 14 once. The treatment cycle propagates until a target temperature reading at accumulated time and / or impedance reading by the system reaches a set or predetermined value that leads to the system ending the treatment cycle.

[0134] The treatment-cycle steps are listed in the illustrative algorithm below and they include, in essence and without limitation, the following primary steps:

[0135] 1. The patient is seated and pretreated with anesthetics;

[0136] 2. The system is powered ON;

[0137] 3. The handle-mounted electrode is placed gently against the skin to be treated;

[0138] 4. The operator presses the start button once;

[0139] 5. Vacuum is turned on;

[0140] 6. Dielectric coolant flows through the electrode bottom troughs;

[0141] 7. Needles are advanced into the dermis by the push of the servo motor;

[0142] 8. Series of pulses of RF current are executed (preferably algorithm governed);

[0143] 9. Temperature and impedance are being sampled continuously;

[0144] 10. When time-at-temperature and / or maximal impedance are detected, pulses stop;

[0145] 11. Needles retracted;

[0146] 12. Coolant flow stops;

[0147] 13. Vacuum stops; and

[0148] 14. Electrode is lifted away and placed onto the next area of the skin to be treated.

[0149] Another valuable feature of the present invention is the introduction of a “Thick Skin Routine” algorithm. 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. Once a “Thick Skin” electrode is identified by the system, a Thick Skin algorithm is preferably engaged to execute two stage, or more, treatment cycles. In such cases, as an example, the needles are inserted to 0.7mm depth into the dermis layer first. A pulse routine is then preferably executed. At the end of the pulse routine, 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.

[0150] 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:

[0151] 1. The type of electrode being selected; and / or

[0152] 2. The predetermined dermis layer’s thickness typical to skin area to be treated by the selected electrode.

[0153] The system herein includes, but not limited to, three (3) sizes of electrodes:

[0154] 1. 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;

[0155] 2. A medium size electrode, intended for general facial, submental space and / or neck skin treatment; and

[0156] 3. A large electrode, intended to be used on all non-facial and / or neck skin areas.

[0157] The thick-skin multi-depth treatment cycle is preferably designed to be used with the medium and large electrodes towards achieving thorough dermis layer controlled-heating towards the desired temperature.

[0158] Patients being treated with the technology described herein are preferably pre-treated by either a topical anesthetic cream or by nerve-blocker injections, to reduce the patient’s discomfort and pain.

[0159] By having dynamic real-time temperature measurement data and knowing the typical dermis layer thickness that correlates with the type of electrode being used, and with the knowledge of the type of anesthetic that was applied, 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.

[0160] For this purpose, 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.

[0161] 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.

[0162] In all types of treatment-cycles as described above, 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. As such, the RF microneedling system as described above offers unprecedented efficacy and outcome by optimizing the heating of the dermis layer, while protecting the epidermis layer and with close attention to the patient’s comfort.

[0163] The RF Microneedling System Algorithms

[0164] An articulate description of the RFMS treatment cycle algorithms is as follows.

[0165] Note: The numerical values in Tables 1 and 2 below are shown as an example. Different values may be programmed as needed.

[0166] Note: All numerical values as listed below for time, depth and temperature are shown to serve as examples only. Actual system values may differ.

[0167] TABLE 1 - PARAMETERS

[0168] TABLE 2 - VARIABLES

[0169] System power is on:

[0170] System turned on

[0171] Constantly check and display temperature

[0172] Constantly measure and display impedance

[0173] If STOP button pressed, stop pulses, stop coolant, stop vacuum, retract electrodes (i.e., needles) - see EMERGENCY STOP ROUTINE

[0174] User selects the type of painkiller and pain tolerance. This information is used to determine power and temperature levels.

[0175] ELECTRODE IDENTIFIED AND SHOWS ON DISPLAY

[0176] Cycle treatment electrode parameters (Watts, times, temperature) are selected and set for the selected electrode

[0177] User gently presses the electrode against the patient’s skin

[0178] User presses and releases START button to begin operation

[0179] Light LED and sound tone until operation completely ends

[0180] Turn VACUUM ON - DELAY 1.5 SEC

[0181] Display “Vacuum On” Turn COOLANT ON - DELAY 1.0 SEC

[0182] Display “Coolant On”

[0183] Deploy needles via servomotor and internal limit switches.

[0184] Display “Needles Activated”

[0185] Begin sending energy pulses - if the THICK DERMIS ELECTRODE is connected, do THICK SKIN ROUTINE. Otherwise, do TEMPERATURE TIME ROUTINE

[0186] Display “Operating”

[0187] Retract needles via servomotor and limit switches

[0188] Display “Needles Off’

[0189] Stop pulses

[0190] COOLANT OFF - DELAY 0.5 SEC

[0191] Display “Coolant Off”

[0192] VACUUM OFF - DELAY 1.0 SEC

[0193] Display “Vacuum Off’

[0194] Loud beep, turn off LED

[0195] Display: “Area complete, move to next spot and press START”

[0196] PULSE ROUTINE:

[0197] Goal: Pending on the electrode type and patient anesthetic pre-treatment, the goal is to heat the dermis layer to a set target temperature between 45-69°C and keep it at that temperature for an accumulated time of 3 seconds. Send 0.X second pulses with 0.Y seconds gap between them until the temperature reaches 65 °C

[0198] 1. If temperature > 65°C, change pulse length to 0.1 seconds and the gaps to 0.6 seconds

[0199] 2. If temperature > 69°C, stop sending pulses until the temperature <66°C?

[0200] 3. If the temperature has been >65 °C for 3 seconds, END ROUTINE

[0201] TEMPERATURE TIME ROUTINE:

[0202] SampleGoal - TimeGoal / TimeSamp / / How many samples are needed at the goal temperature

[0203] Set Scount = 0

[0204] While SCount <= SampleGoal

[0205] 1. Sample the temperature

[0206] 2. If temp < TempMin, do PULSE ROUTINE

[0207] 3. If temp > TempMax do HIGH TEMPERATURE WARNING ROUTINE 4. If temp > TempMin, SCount ++ / / increment the SCount if temperature is in goal range

[0208] If SCount >= SampleGoal, do END ROUTINE

[0209] For example, for a patient treated with topical anesthetics, typical values could be: TempMin = 52°C, TempMax = 58°C, TimeGoal = 3 seconds.

[0210] For a patient treated with nerve blockers, typical values could be: TempMin = 65°C, TempMax = 69°C, TimeGoal = 3 seconds.

[0211] THICK SKIN ROUTINE:

[0212] 1. Extend the needles to maximum depth (4mm)

[0213] 2. Do PULSE ROUTINE

[0214] 3. Retract needles to half depth (2mm)

[0215] 4. Do PULSE ROUTINE

[0216] END ROUTINE:

[0217] 1. Stop pulses

[0218] 2. Pause 0.5 seconds

[0219] 3. STOP COOLANT

[0220] 4. Retract needles

[0221] 5. Pause 0.5 seconds

[0222] 6. Stop vacuum

[0223] 7. Display message “Treatment cycle completed, move to next site”

[0224] EMERGENCY STOP ROUTINE:

[0225] 8. Stop pulses

[0226] 9. Pause 0.5 seconds

[0227] 10. STOP COOLANT

[0228] 1 1 . Retract needles

[0229] 12. Pause 0.5 seconds

[0230] 13. Stop vacuum

[0231] 14. MESSAGE: CYCLE STOPPED BY USER

[0232] While the present invention has been described with reference to an exemplary embodiment, it will be understood by those skilled in the art that various changes can be made and equivalents can be substituted for elements thereof without departing from the scope of the present invention. In addition, many modifications can be made to adapt a particular situation or material to the teachings of the present invention without departing from the essential scope thereof. Therefore, it is intended that the present invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this present invention, but that the present invention will include all embodiments falling within the scope of the appended claims.

Claims

CLAIMSWhat is claimed is:

1. 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 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 coolant; wherein when the array of needles is caused to penetrate the dermis layer of the patient’ s skin, the source of radio frequency bipolar electrical current causes a series of pulses to the array of needles so as to heat the dermis layer of the patient’ s skin; wherein when the array of needles heats the dermis layer of the patient’s skin, the source of coolant causes a flow of coolant onto an epidermis layer of the patient’s skin.

2. The system according to claim 1, further comprising a thermistor system operably associated with the distal portion of at least one of the needles.

3. The system according to claim 2, wherein 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 pre-determined temperature.

4. The system according to claim 1, wherein the array of needles penetrates the dermis layer of the patient’s skin to a first depth, wherein 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.

5. The system according to claim 4, wherein the array of needles penetrates the dermis layer of the patient’s skin to a second depth, wherein the source of radio frequency bipolar electrical current causes a second series of pulses to the array of needles so as to heat the second depth of the dermis layer of the patient’ s skin.

6. The system according to claim 5, wherein 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.

7. The system according to claim 6, wherein 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.

8. 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 a 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, the source of radio frequency bipolar electrical current causes a series of pulses to the array of needles so as to heat the dermis layer of the patient’ s skin; wherein when the array of needles heats the dermis layer of the patient’s skin, the source of dielectric coolant causes a flow of dielectric coolant onto an epidermis layer of the patient’ s skin.

9. The system according to claim 8, wherein 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 pre-determined temperature.

10. The system according to claim 8, wherein the array of needles penetrates the dermis layer of the patient’s skin to a first depth, wherein 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.

11. The system according to claim 10, wherein the array of needles penetrates the dermis layer of the patient’s skin to a second depth, wherein the source of radio frequency bipolar electrical current causes a second series of pulses to the array of needles so as to heat the second depth of the dermis layer of the patient’ s skin.

12. The system according to claim 11, wherein 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.

13. The system according to claim 12, wherein 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.

14. 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 layer of the patient’ s skin to a second depth, the source of radio frequency bipolar electrical current causes a second series of pulses to the array of needles so as to heat the second depth of the dermis layer of the patient’s skin; wherein when the array of needles heats either of the first and second depths of the dermis layer of the patient’s skin, the source of dielectric coolant causes a flow of dielectric coolant onto an epidermis layer of the patient’s skin.

15. The system according to claim 14, wherein 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 pre-determined temperature.

16. The system according to claim 14, wherein 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.

17. The system according to claim 16, wherein 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.

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