IL265944A - Massage glove - Google Patents

Description

MEDAV-001 IL MASSAGE GLOVE FIELD OF THE INVENTION

[001] The present invention relates in general to skin and muscle care, specifically to gloves and methods for massaging the skin and muscle of a person while emitting radio frequencies to improve skin properties and relax muscles.

BACKGROUND

[002] In the modern society there is a demand for a younger look and a better appearance. As a result, various technological devices have been created in recent years to address this need. The demand for a rapid, non-invasive and painless process with good and noticeable outcome is thus needed.

[003] The skin is the largest organ in the human body. It is composed of 3 main layers: epidermis, dermis, and hypodermis (subcutaneous tissue). The outer layer is the epidermis, which is a stratified, squamous epithelium layer composed primarily of two cell types: keratinocytes and dendritic cells. The deepest layer of the skin is the hypodermis, which is the fat tissue that isolates the body from cold temperatures and provides shock absorption. The dermis is the middle layer of the akin, and is an integrated system of fibrous, filamentous, and amorphous connective tissue. The dermis contains two sections: the papillary and the reticular.

[004] The papillary layer is made of a loose connective tissue, meshed from collagen and elastin fibers. This superficial layer of the dermis projects into the stratum basal of the epidermis to form finger-like dermal papillae. Beneath the papillary layer is the reticular layer which is much thicker and consist of dense irregular connective tissue (mainly collagen fibers). In addition, the reticular layer contains elastin fibers that provide some elasticity to the skin and enable movement.

[005] With age, the collagen fibers that provide structural and tensile strength lose their thickness and their ability to rejuvenate the skin. In addition, collagen binds water to keep the skin hydrated, which means that with age, due to deterioration of the collagen, the skin dehydrates.

[006] Collagen is a hard, insoluble, and fibrous protein that makes up one-third of the proteins in the human body. In most collagens, the molecules are packed together to form long, thin fibrils. These act as supporting structures and anchor cells to each 1 MEDAV-001 IL other. They give the skin strength and elasticity. There are different types of collagen, but 80 to 90 percent of them belong to types 1, 2, and 3, each has a different structure and function.

[007] The ageing process and sun-induced skin damages led to the development of various cosmetic skin treatments for skin rejuvenation such as: creams and ointments, lasers, and even cosmetic surgery. Such treatments can improve wrinkles and skin appearance, for short and long terms, depending on the treatment.

[008] Some examples of known skin rejuvenation treatment and methods are: (i) Tria Age-Defying Laser: the laser stimulates the production of collagen and elastin to diminish skin damages over the years in a couple of weeks. Targeted beams of laser penetrate the skin to stimulate the natural healing process, which includes reproduction of natural collagen. However, the treatments have to be done on a daily basis, and are somewhat painful. (ii) FaceFX: a 645 nm red LED is used to improve skin tone, color and texture. The device is based on Home Fractional (HF) technology, which is a synergistic combination of red light and dermal heating that targets the top layer of the skin. However, using this device requires a lot of time per treatment; it is not effective for all patients; and it is inconvenient due to charger length and short shelf-life.

[009] Nevertheless, all of these treatments, and others, suffer from various drawbacks, such as limited efficacy, high incidence of side effects, high cost and/or long recuperating (i.e. from surgery). Contrary to these and other techniques, the use of radiofrequency RF energy to rejuvenate the skin provides a noninvasive method and shortens, and nearly eliminates, the patient recovery time.

SUMMARY

[010] In a first embodiment, the present invention provides a glove-device comprising: (a) a glove; (b) at least one radio-frequency (RF) transducer on each one of the 4 fingers of said glove; and (c) at least one temperature sensor.

[011] In a second embodiment, the present invention provides a RF-inducing system comprising: (a) a glove-device comprising: (i) a glove; (ii) at least one RF-transducer on each one of the 4 fingers of said glove; and (iii) at least one temperature sensor; (b) a RF signal generator; (c) a controller; and (d) a computing system comprising at least one processor and at least one memory communicatively coupled to the at least one processor, the memory comprising computer-readable instructions that when executed 2 MEDAV-001 IL by the at least one processor cause the computing system to start or stop RF transduction, wherein components (b), (c) and (d) are optionally an integral part of the glove-device.

[012] In a third embodiment, the present invention provides a method for transducing RF onto a skin of a patient for rejuvinating the skin, the method comprising: (a) placing a glove-device according to any one of claims 8-10 onto a therapist palm; (b) activating the RF signal generator; and (c) pressing the glove against the patient's skin, and massaging thereof, thereby transducing RF onto the patient's skin via the RF- transducers within the glove to rejuvinate the skin.

BRIEF DESCRIPTION OF DRAWINGS

[013] Fig. 1 is a schematic description of the electrical circuit and components of one embodiment of a RF-inducing system according to the invention.

[014] Fig. 2 is a scheme illustrating one possible configuration of a user interface via MatLab Gui.

[015] Fig. 3 is a block diagram illustrating the communication between an Arduino Uno and MatLab software during activation of a RF-inducing system according to the invention.

[016] Figs. 4A-4C are pictures showing the positioning of electrodes on different body parts: Fig. 4A- cheek; Fig. 4B- back of palm; and Fig. 4C- arm.

[017] Figs. 5A-5C are graphs showing skin resistance on different body parts as measured in Figs. 4A-4C: Fig. 5A- cheek; Fig. 5B- back of palm; and Fig. 5C- arm.

DETAILED DESCRIPTION

[018] The present invention provides devices that rejuvenate the skin using radiofrequency (RF) technology. The devices of the invention are based on a glove- shaped instrument that is incorporated with RF-transducers capable of transmitting harmless RF waves to the skin, so that the RF can be applied onto a patient's skin while maneuvering the glove over the skin. In addition, the glove-device of the invention is connected to a RF-signal generator, a controller and a computer.

[019] The RF signal is transmitted by the glove-device of the invention onto the patient's skin and heats up the natural collagen fibers found in the body. This 3 MEDAV-001 IL stimulation encourages production of new cells of collagen, which strengthen the skin structure and rejuvenate the skin's appearance.

[020] Notably, RF pulse is safe to other nearby tissues and doesn't affect the melanin of the skin. Therefore, RF transduction can be used by patients of all skin types.

[021] Collagen fibers consist of triple helix strands of protein containing strong hydrogen bonds that deteriorate over time. However, application of thermal energy over a period of time contracts, compresses, and thickens the collagen fibers, thus assisting in aesthetic rejuvenation of the skin, restoring skin laxity and reducing aging symptoms of the skin. Accordingly, thermal collagen contraction is a promising way to improve aesthetic rejuvenation, restoring skin laxity and reduce/reverse aging collagen shrinkage. The duration of heat exposure is variable according to the area being exposed, the type of skin and collagen being treated, and the overall damage of the treated skin. In specific embodiments, the duration is set by the therapist, and can be set to, e.g., 5 minutes.

[022] Accordingly, in a first embodiment, the present invention provides a glove- device comprising: (a) a glove; (b) at least one radio-frequency (RF) transducer on each one of the 4 fingers of the glove; and (c) at least one temperature sensor (see, e.g., Fig. 1). In a specific embodiment, the glove-device further comprises at least one radio-frequency (RF) transducer on the thumb of the glove.

[023] In a second embodiment, the present invention provides a RF-inducing system comprising: (a) a glove-device comprisnig: (i) a glove; (ii) at least one radio- frequency (RF) transducer on each one of the 4 fingers of said glove; (iii) at least one temperature sensor; and (iv) optionally at least one safety switch; (b) a RF signal generator; (c) a controller; and (d) a computing system comprising at least one processor and at least one memory communicatively coupled to the at least one processor, the memory comprising computer-readable instructions that when executed by the at least one processor cause the computing system to start or stop RF transduction, wherein (b)-(d) are optionally an integral part of said glove-device.

[024] In certain embodiments, the glove-device of the invention further comprises at least one of: (i) a controller, based on, e.g., Raspberry pi and Arduino Uno; (ii) a temperature sensor, such as TMP36, DS18B20, LM35DZ & NTC-MF52-103/3435; (iii) RF-signal generator(s), such as RF Signal Generator SM300 and Series Waveform 4 MEDAV-001 IL Generators 33500B; and (iv) heat insulation element(s), such as Cool Grip ID:SKX- W4, Heat resistance 100 C, and SHOWA 8814.

[025] In order to prevent unnecessary RF transmission when the glove-device is not in use or not in direct contact with the patient's skin, special contact sensors or kill- switches may be used. Accordingly, in certain embodiments, the glove-device of the invention further comprises at least one safety switch. In specifc embodiments, there is a safety switch on each one of the 4 fingers of the glove (see, e.g., X in Fig. 1). In a frurther specifc embodiment, there is a safety switch on the thumb of the glove. The safety switch(es) is designed to deactivate the glove-device, i.e. the transmission of the RF, when the glove-device is not in contact with the patient's skin.

[026] In specific embodiments, the glove-device of the invention further comprises a controller designed to enable the user to activate/deactivate the glove-device and the RF transmission, and optionally to set various operation parameters/values, such as duration of RF transmission, intensity of the RF, desired temperature, etc. In specific embodiments, the glove-device further comprises a screen, optionally as part of the controller, for displaying various parameters, such as skin temperature, RF transducing time, RF values, etc. As illustrated in Fig. 2, the controller may comprise on/off botton(s), as well as various disply windows for the time remaining/passing and the temperature of the skin. It may also include means to control the frequency and power of the RF. It should be noted that Fig. 2 is an ilustration only and does not mean to limit the inveniton. A skilled artisan would easliy know how to modify this exemplified controller according to need and desire.

[027] The ideal energy, power, frequency and time of RF applied can be determined using Oh , which refers to the heat created by the natural resistance of the transport of electrons within a tissue, the required RF field needed to be used can be calculated using the following equation: J = here I is current, R is tissue impedance, and T is time of application.

[028] Resistance of a tissue to RF pulse(s) can be produced within the various layers of the skin. Electrical current caused by the resistance of various layers of the skin is transferred into thermal energy, which facilitates new collagen production by the skin.

The tissue thickness/depth must be taken into consideration due to the different effect of the RF pulse: every layer has different degrees of impedance to the RF energy.

MEDAV-001 IL

[029] It should be noted that RF energy can be applied to the skin using a probe with a single electrode tip and a grounding plate (monopolar F first-generation RF technology), or a probe with two points/electrodes (bipolar F second-generation RF technology). Each technique has its own requirements. For instance, a bipolar device requires less current compared to a monopolar device in order to achieve the same effect, because the current passes through a much smaller volume of tissue. Notably, the penetration depth of the RF energy into a tissue can be evaluated to be half the electrode size in a monopolar RF device, compared to half the distance between the electrodes in a bipolar RF device.

[030] In certain embodiments, the glove-device of the invention is operated using suitable operation software, such as CVI, MatLab, Visual studio, & Python. The software may be customized according to need and desire, and is designed to take into consideration various parameters such as the type of treatment, type of patient's (age, health condition, etc.), private or commercial use, etc.

[031] In certain embodiments of the glove-device of the invention, the at least one RF-transducer is associated with an external RF signal generator, e.g. via electric wires. This RF signal generator is responsible for generating the RF signal that in turn is transduced via the RF-transducer(s) to the patient's skin. The RF signal generator is designed to provide the RF-transducers the RF values for transducing. In addition, in order to avoid overheating of the skin, the temperature sensor(s) measures the skin temperature and transmits the measured temperature to the computer, either directly or via the controller, while the computer calculates and evaluates whether the temperature reached a level that requires the system to stop the TF transducing. One non-limiting example of such a sensor is a Thermistor Temperature Sensor NTC-MF52-103/3435,

[032] In certain embodiments, the glove is made of or comprises heat resistance material(s) to isolate the therapist/glove-wearer from any generated heat and/or unintentional electric shocks. For instance, the glove may be made of cotton. In certain embodiments, the gloves are made of two or more layers, wherein one layer is heat- resistance and another layer is electricity isolated. In specific embodiments, the same layer is both heat-resistance and electricity isolated.

[033] In certain embodiments, the glove-device of the invention further comprises a computing system comprising at least one processor and at least one memory 6 MEDAV-001 IL communicatively coupled to the at least one processor, the memory comprises computer-readable instructions that when executed by the at least one processor cause the computing system to start or stop RF transduction.

[034] In certain embodiments, the computing system is designed to calibrate the tempera + values- either manually by the user or automatically. For instance, RF values may vary between about 0.3 to about 10 MHz

[035] Notably, the RF generates heat. Accordingly, in order to prevent unintentional heat and/or RF exposure to the therapist's palm, the glove-device may include at least one insulating layer designed to isolate the therapist palm from the RF and/or heat. Thus, in certain embodiments, the glove-device of the invention further comprises a RF-isolation and/or heat isolation layer.

[036] In certain embodiments, the gloves are light weighted, i.e. no more than 100 gr, including the RF-transducers.

[037] In certain embodiments, the glove-device is equipped with various safety measures to prevent unintentional damage to both the patient and the therapist. Some of these safety measures are aimed at stopping the glove- needed. In specific embodiments, the temperature sensor(s) receives temperature data from the skin and sends same to the computer, which determines whether the measured temperature is within a predefined acceptable range, and if the temperature exceeds the acceptable temperature limit, the computer shuts down the RF generators and/or the RF-transducers. For instance, in specific embodiments, if the skin operation will stop immediately.

[038] Another safety mechanism of the glove-device according to any of the embodiments above is an activation switch (kill-switch) that enables passage of current and RF-transducing only during treatment, i.e. when the glove-device is in direct contact with the patient's skin. This can be achieved, e.g., by a pressure sensor or a switch that identifies contact with the skin and enables passage of electricity during the treatment period (see, e.g., safety switch in Fig. 1). When a treatment is not performed, the RF source is turned off, so there is no risk of electric shock or over- operation of the glove-device. 7 MEDAV-001 IL

[039] In certain embodiments, the glove-device according to any of the embodiments above further comprises a fine mesh. The mesh constitutes yet another possible safety mechanism for the therapist/glove-wearer against possible damages from the transduced RF. In specific embodiments, the mesh is made from stainless steel and is flexible to enable the therapist to move his/her fingers during treatment. In further specific embodiments, the mesh has high tensile strength, anti-rust, anti-acid and anti-corrosion properties, easy to maintain and is durable up to 150 it can be sterilized). In yet further specific embodiments, the mesh is an integral layer within the glove-device (among other layers).

[040] In certain embodiments, the glove-device according to any of the embodiments above is disposable. In alternative embodiments, the glove-device is re-usable. In other alternative embodiments, the glove-device is re-usable and further comprises a disposable cover-layer that can be replaced after each use. In all cases, the glove- device is made of materials that can undergo a sterilization process. One non-limiting example of such a sterilization process is vapor sterilization at and for -30 min. In specific embodiments, the electrical components within the gloves are coated or fabricated such that they are isolated / water-resistant to avoid damage during the sterilization process and/or during use (e.g. due to sweat from the patient's skin).

[041] Fig. 1 is a schematic description of the electrical circuit of one embodiment of a glove-device according to the invention showing the electrical wires running within/on temperature sensors and RF-transducers attached to the palm part of the glove, as well as the RF generator(s) and the controller, both remotely located and associated with the glove-device.

[042] In a specific embodiment, the RF signal generator is a "floating system" and thus the glove-device further comprises a transformer that optionally further prevents radio frequency interference.

[043] One of the main components in the electrical system is the controller. In a specific embodiment, the controller is an Arduino Uno controller.

[044] In specific embodiments, the glove-device according to any of the embodiments above is operated by two main softwares: CVI, MatLab and Arduino IDE, which are designed to communicate with each other in real-time. The software comprises various safety mechanisms to prevent unintentional damage to both the therapist and the patient. For instance, the program limits the transduced RF frequency 8 MEDAV-001 IL to a predefined maximum level, such as a frequency of 10MHz and 5W power, which means that the user cannot insert/use a higher frequency that might cause damage. In specific embodiments, the software further comprises a timer, so that after a predefined period of time the glove-device stops working for a short (predefined) time.

[045] Fig. 2 illustrates one possible configuration of a user interface via MatLab Gui. In specific embodiments, the input values are: Frequency- 0.3~10MHz; and Power- 1~5W. Start/Stop buttons are for manually activating/stopping the glove- device/treatment. The "Time Elapsed" window displays how much time passed since the beginning of the treatment or the time remaining until the end of the treatment; and the "Temperature" window displays the skin's temperature in real time.

[046] Fig. 3 is a block diagram illustrating the operation of the glove-device using a MatLab software: the therapist first sets the required power and required duration through the Matlab User Interface (UI), which in turn activates the RF generator(s).

The signals as entered through the UI are then sent to the electrodes/probes and the timer is activated. The UI will stop the process as soon as the time elapses. Since the temperature is set in advance to 42 C, a tolerance of +2 C is acceptable. If the reading of the temperature from the sensors reaches 42 C, a command will be sent through Matlab to shut down the glove-device/RF generator(s).

[047] The present invention further provides a method for transducing radio frequency (RF) onto a skin of a patient for rejuvinating the skin, the method comprising: (a) placing a glove-device according to any one of claims 8-10 onto a therapist palm; (b) activating the RF signal generator; and (c) pressing the glove against the patient's skin, and massaging thereof, thereby transducing RF onto the patient's skin via the RF-transducers within the glove to rejuvinate the skin.

[048] In certain embodiments of the above method, the temperature sensor measures the skin's temperature and trnasmits the measured temperature to the computer, which based thereon determines whether to stop the RF transductions or not; when disconnecting one of the safety switches (if present) from the patient's skin leads to the arrest of RF transductions; and/or the computer stops the RF transductions after a predefined period of time of continuous RF transduction. 9 MEDAV-001 IL Experiments Test Protocol

[049] Preliminary tests were made to get the connection between skin resistance and frequency. From these parameters it is possible to know the required current in the system so the treatment will be efficient. It is concluded that in order to get superior results while using the glove-device of the invention, a 5W power need to be used.

These tests provide an indication of the current amplifier that would be needed for this system.

[050] The experiment was performed in several areas: (a) Face- the electrodes were placed in the middle of the cheek as shown in Fig. 4A; (b) Palm- the electrodes were placed on the backhand as shown in Fig. 4B; and (c) Arm- the electrodes were placed at the "inside" area of the forearm as shown in Fig. 4C.

[051] The electrodes in the experiment were iron-made, round-shaped with a diameter of 1.5 cm. The distance between the electrodes was 3 cm.

[052] During the experiments, a RF signal generator was connected to the electrodes with a resistor connected in serial connection to one of the electrodes. An oscilloscope was used to measure the voltage of the resistant and the voltage between the two electrodes.

[053] Each experiment was performed 4 times in each body part on two female participants. The results were then processed and standard deviations were obtained, which can be seen in the graphs in Figs. 5A-5C.

[054] Different frequencies were examined and in conclusion only the high frequencies exhibited a linear behavior. This is due to the low skin resistance in these values, i.e. from 50 to 120 Ohm. Thus the chosen frequencies for the analysis are: 6.5- MHz.

[055] In addition, it can be seen that the different participants yielded close results and this is due to the RF technology, which is not affected by different parameters such as skin tones, age and gender. From the test results it is concluded that the current that is needed for efficient application for each area. The results are summarized in Tables 1-3 below: MEDAV-001 IL Table 1 Calibrated magnitude for facial area treatment Frequency Mean Skin resistance Power [w] Current [A] [MHz] (Participant 1 and 2) [Ohm] 6.5 95.51 5 0.229 7.5 82.43 5 0.246 8.5 72.92 5 0.262 9.5 66.92 5 0.273 62.05 5 0.284 Table 2 Calibrated magnitude for palm area treatment Frequency Mean Skin resistance Power [w] Current [A] [MHz] (Participant 1 and 2) [Ohm] 6.5 92.83 5 0.232 7.5 82.01 5 0.247 8.5 72.8 5 0.262 9.5 64.76 5 0.278 60.39 5 0.288 Table 3 Calibrated magnitude for arm area treatment Frequency Mean Skin resistance Power [w] Current [A] [MHz] (Participant 1 and 2) [Ohm] 6.5 93.06 5 0.232 7.5 82.41 5 0.246 8.5 73.32 5 0.261 9.5 65.36 5 0.277 61.06 5 0.286

[056] In conclusion, the results show that the skin area and type being treated by RF- transduction have no effect on the values obtained. This means that the current values are similar for all body areas and skin types.

Treatment Protocol

[057] Based on known devices for skin treatment, such as the TriPollar Stop, a preliminary recommended treatment protocol is to use the glove-device of the invention 3 times a week for 5 min. each time for a period of 6 to 8 weeks. 11 MEDAV-001 IL System Testing

[058] The glove-device according to any of the embodiments above consists of several components that need to be tested- after assembly and/or before each intended use of the glove-device or periodically. The system testing will be performed on a metal cylinder special dents for each electrode in the glove and a temperature sensor. Various parameters are tested: shut down after a predetermined period of time of continuous working (e.g. 5 min.) to verify that the "timer" works; the functionality of all the safety switches to verify safety measures; overheating test to check the temperature sensor and verify that the operation system stops activation of the glove-device when the temperatures exceeds a predefined temperature.

[059] The operation system will be tested also separately from the glove-device to eliminate malfunctions that may occur. The test will be performed with a test box and the software will be checked for bugs. The test box will contain toggle buttons to mimic the switches the glove has:

[060] Safety switches activity Firstly it will be checked that the system is working properly while all the buttons are pressed. Than while all the buttons are pressed one of the buttons will be released. This will be done for each button and if each time the system shuts down, then the software is operating well. This test should be repeated on each button several times to ensure that the system recognizes it and the software operates well.

[061] Operating the treatment in the desired time The test will be perfumed in the following way: all the buttons will be pressed for over 5 min. (or any other predefined period of time). If the system shuts down after that time, then the software operates well and it is safe to use.

[062] Overheating Each button in the box will be defined in the software for this test to mimic a temperature sensor. When the button is pressed its equal to a temperature of, e.g., 44 and over. This will represent the skin temperature while overheating. Then, each button will be pressed separately, and if each time the system shuts down, then the test is a success.

[063] In addition the software itself will be tested for bugs. 12

Claims (14)

MEDAV-001 IL Claims:

1. A glove-device comprising: a) a glove; b) at least one radio-frequency (RF) ucer on each one of the 4 fingers of said glove; and c) at least one temperature sensor.

2. The glove-device of claim 1, r comprising at least one safety switch.

3. The glove-device of any one of claim 1 or 2, further sing a controller.

4. The glove-device of any one of claims 1-3, wherein said at least one RF- transducer is associated with an external RF signal generator.

5. The glove-device of any one of claims 1-4, further comprising a computing system comprising at least one processor and at least one memory communicatively coupled to the at least one processor, the memory comprising computer-readable instructions that when executed by the at least one processor cause the computing system to start or stop RF transduction.

6. The glove-device of any one of claims 1-5, further comprising a lation and/or heat ion layer..

7. The glove-device of any one of the preceding claims, further comprising a able cover that can be discarted and replaced after use.

8. A RF-inducing system comprising: a) a glove-device comprisnig: (i) a glove; (ii) at least one radio-frequency (RF) transducer on each one of the 4 fingers of said glove; (iii) at least one temperature sensor; and (iv) optionally at least one safety switch; 13 MEDAV-001 IL b) a RF signal generator; c) a ller; and d) a computing system comprising at least one processor and at least one memory communicatively coupled to the at least one processor, the memory comprising computer-readable instructions that when ed by the at least one processor cause the computing system to start or stop RF transduction, wherein (b)-(d) are optionally an integral part of said glove-device.

9. The system of claim 8, wherein said at least one glove-device is further equipped with a RF-isolation and/or heat isolation layer.

10. The system of claim 8 or 9, wherein said glove-device further comprises a disposable cover that can be discarted and replaced after use.

11. A method for transducing radio frequency (RF) onto a skin of a patient for rejuvinating the skin, the method comprising: a) placing a glove-device according to any one of claims 8-10 onto a therapist palm; b) ting the RF signal generator; and c) pressing the glove against the patient's skin, and massaging thereof, thereby transducing RF onto the patient's skin via the RF-transducers within the glove to rejuvinate the skin.

12. The method of claim 11, wherein the temperature sensor measures the skin's temperature and its the measured temperature to the computer, which based thereon determines whether to stop the RF transductions or not.

13. The method of claim 11 or 12, wherein necting one of the safety switches (if present) from the patient's skin leads to the arrest of RF transductions.

14. The method of any one of claims 11-13, wherein the er stops the RF32 0 R transductions after a ined period of time of continuous RF uction. For the Applicant Ben-Ami & Associatees 14 Patent Attorneys