COSMETIC SKIN REJUVINATION

Abstract

A device for cosmetic treatment of human skin, including: a needle for inserting into the skin; a DC power source electrically connected to the needle for providing negative current to the needle; an anode that is electrically connected to the DC power source to receive positive current, and that is adapted to be placed in contact with the skin of the person into which the needle is inserted to form a closed electrical circuit; at least one RF transmitter coupled to the needle for radiating the area around where the needle is inserted to provide heat while the needle is deployed.

Claims

1-15. (canceled)

16. A cosmetic method for treating a patient's skin, comprising: providing an array of needles, deploying the array of needles to a specific depth into the patient's skin such that at least a tip of one of the array of needles is deployed within the muscle layer of the patient's skin; providing a DC power source and one or more radio frequency (RF) transmitters coupled to the array of deployed needles; applying a negative DC voltage to said array of deployed needles from the DC power source, while the patient is in contact with a positive electrode to form a closed circuit of DC current through the patient's body; providing the DC current for a pre-selected amount of time to treat muscles and/or muscle nerve cells in the muscle region of the patient's skin; transmitting RF radiation from the one or more RF transmitters for a pre-selected period of time to heat up the deployed needles and patient's skin; and wherein the RF radiation is transmitted separately from the application of DC voltage and only when the DC voltage is turned off and vice versa.

17. The method according to claim 16, further comprising providing hollow conduits in said array of deployed needles and the step of supplying liquids into the skin through the hollow conduits formed in said needles.

18. The method according to claim 16, further comprising measuring electrical resistance of the closed circuit to determine the depth of the array of deployed needles in the patient's skin.

19. The method according to claim 18, further comprising providing an indication of said depth.

20. The method according to claim 16, wherein said array of deployed needles are deployed so as to locate their tips below the subcutaneous layer.

21. The method according to claim 18, wherein the electrical resistance is measured before and after treatment to determine the level of success of the treatment.

22. The method of claim 17, further comprising a syringe for supplying the liquids.

23. The method of claim 22, further comprising a motor to control the supply of the liquids from the syringe into the skin.

24. The method of claim 16, wherein said array of deployed needles are partially insulated and the tips of the array of needles are not insulated.

25. The method of claim 16, further comprising the step of providing one of the same or different current to each needle of the array of deployed needles.

26. The method of claim 16, wherein the array of deployed needles each serve as a cathode and wherein the positive electrode serves as an anode.

27. An apparatus for cosmetically treating a patient's skin, comprising: an array of needles, the array of needles being configured to be deployed to a specific depth into the patient's skin such that at least a tip of one of the array of needles is deployed within the muscle layer of the patient's skin; a DC power source and one or more radio frequency (RF) transmitters coupled to the array of deployed needles; wherein a negative DC voltage is configured to be applied to said array of deployed needles from the DC power source while the patient is in contact with a positive electrode that forms a closed circuit of DC current through the patient's body; wherein the DC current is configured to be applied for a pre-selected amount of time to treat muscles and/or muscle nerve cells in the muscle region of the patient's skin; wherein RF radiation from the one or more RF transmitters is configured to be transmitted for a pre-selected period of time to heat up the deployed needles and patient's skin; and wherein the RF radiation is configured to be transmitted separately from the application of DC voltage and only when the DC voltage is turned off and vice versa.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The present invention will be understood and better appreciated from the following detailed description taken in conjunction with the drawings. Identical structures, elements or parts, which appear in more than one figure, are generally labeled with the same or similar number in all the figures in which they appear, wherein:

[0044] FIG. 1 is a schematic illustration of a side sectional view of skin and underlying layers;

[0045] FIG. 2 is a schematic illustration of a device for treating skin, according to an exemplary embodiment of the invention;

[0046] FIG. 3 is a schematic illustration of an alternative handpiece with an array of needles, according to an exemplary embodiment of the invention;

[0047] FIG. 4 is a flow diagram of a cosmetic skin treatment process, according to an exemplary embodiment of the invention;

[0048] FIG. 5 is a schematic illustration of a side sectional view of skin with a needle deployed for treating muscles below the subcutaneous layer, according to an exemplary embodiment of the invention;

[0049] FIG. 6 is a schematic illustration of a side sectional view of skin with a needle deployed for treating fatty areas in the subcutaneous layer, according to an exemplary embodiment of the invention;

[0050] FIG. 7 is a schematic illustration of a side sectional view of skin with a needle deployed for treating collagen in the dermal layer, according to an exemplary embodiment of the invention;

[0051] FIG. 8A is a schematic illustration of a single injection needle performing electrolysis, according to an exemplary embodiment of the invention; and

[0052] FIG. 8B is a schematic illustration of an array of injection needles performing electrolysis, according to an exemplary embodiment of the invention.

DETAILED DESCRIPTION

[0053] FIG. 2 is a schematic illustration of a device 200 for treating skin 100, according to an exemplary embodiment of the invention. In an exemplary embodiment of the invention, a negative electrode of a DC circuit is provided as a needle 240 in device 200. The needle 240 is adapted to be inserted into the skin 100 of a person for performing electrolysis. Optionally, the needle has a small diameter, for example between 50-500 microns so that it does not cause noticeable damage to the outer layer of the skin when inserted into the skin.

[0054] A person's skin 100 contains moisture made of water (H.sub.2O) and salt (NaCl). The amount of moisture tends to rise the deeper you penetrate into the skin, for example the dermis 30 tends to be more moist than the epidermis 20 and the fatty areas in the subcutaneous layer 40 tend to be more moist than the dermis 30. The negative electric current causes some of the water and the salt molecules of the moisture to break up into Ions (Na.sup.+, Cl.sup.−, H.sup.− and OH.sup.+). The positive Ions (Na.sup.+ and OH.sup.+) move towards the negative electrode and recombine to form an Alkali Sodium-Hydroxide (NaOH). The Sodium-Hydroxide is highly caustic and destroys cell tissue located in the area of needle 240 when the negative DC voltage is applied.

[0055] The amount of Sodium Hydroxide, popularly referred to as units of Lye, depends on the current intensity and on the duration of applying the current. A unit of Lye is defined as the product of applying a tenth of a milliamp of current for 1 second. The moisture content of skin 100 increases the conductivity so that if the moisture is higher current will flow faster and the production of Lye will be increased.

[0056] In an exemplary embodiment of the invention, needle 240 extends from a handpiece 220, which can be held by the user to treat the skin 100 of a person. Optionally, needle 240 is hollow forming a conduit, and handpiece 220 includes a syringe 236, which can be filled with a liquid, for example saline from an external container 235. During application of current to the needle, syringe 236 may deliver liquid through the hollow of needle 240 to its tip to enhance the chemical process. In some embodiments of the invention, handpiece 220 includes a motor 234 to control syringe 236, so that the amount of liquid can be delivered accurately, for example a drop every few seconds. In some embodiments of the invention, other materials may be delivered for various purposes, for example anesthetics, Lidocaine, Epinephrine, growth factors, stem cells, or Botulinum toxin.

[0057] In some embodiments of the invention, needle 240 is covered or coated with an insulator 260 so that the DC current will be delivered more accurately—only at the tip of needle 240. Alternatively, the DC current may be delivered by contact with skin 100 along the entire length of needle 240.

[0058] In an exemplary embodiment of the invention, handpiece 220 includes one or more RF transmitters 232 that provide a high frequency electromagnetic radiation directed toward skin 100. Optionally, when deploying needle 240 into skin 100 RF transmitters 232 are used to heat the position where the chemical process is occurring to speed up the chemical process. Optionally, RF radiation may be applied continuously to keep the area warm or may be applied simultaneously when DC voltage is applied or separately only when the DC voltage is turned off. In some embodiments of the invention, the RF radiation only provides enough heat to enhance the effectiveness of the chemical process. Alternatively, the RF radiation may provide enough heat to destroy cells on its own, for example by thermolysis using cauterization or coagulation, in addition to the chemical process that is induced by the DC voltage.

[0059] Optionally, the application of both DC voltage and RF radiation simultaneously or intermittently reduces the time required to achieve the desired result, and may reduce the required current, for example using 0.2 to 0.7 milliamp instead of 0.5 to 1 milliamp

[0060] In an exemplary embodiment of the invention, device 200 includes an electrical unit 210 for providing electrical power and controlling the function of handpiece 220. Optionally, electrical unit 210 is coupled to handpiece 220 by way of an electrical cable 226. In an exemplary embodiment of the invention, electrical unit 210 includes a DC current supply 222 to provide regulated negative voltage to needle 240. In an exemplary embodiment of the invention, DC current supply 222 provides a constant current regardless of the load, so that the current is not affected by resistance changing during treatment.

[0061] Additionally, electrical unit 210 may include an AC current source to provide current to RF transmitters 232 or the RF transmitter may be power by DC current. In an exemplary embodiment of the invention, an anode 230 is connected by a cable 228 to electrical unit 210. Anode 230 is held by or attached to the person being treated to form a closed electrical circuit through the body of the person being treated.

[0062] In some embodiments of the invention, electrical unit 210 includes a resistance sensor that measures the resistance through the DC circuit between needle 240 that serves as the cathode, and anode 230. Optionally, the resistance value may be displayed on a display 214 or may give off audible signals (e.g. more rapid or less rapid) or other indications, so that the user of device 200 may estimate the depth of needle 240 based on the signals, since the resistance of the skin 100 differs at different depths.

[0063] In some embodiments of the invention, electrical unit 210 may include a processor or logic circuit to facilitate a control unit 218. Optionally, control unit 218 may include several programs for controlling the device and the user selects the desired program, for example by setting switches or dials 212. In some embodiments of the invention, control unit 218 is programmable. Optionally, device 200 can be connected to a computer (e.g. through an I/O port) to receive commands regarding the control of device 200.

[0064] Optionally, the functions controlled by control unit 218 may include the following:

[0065] 1. Display of status details on display 214;

[0066] 2. Provision of power (e.g. DC or AC) to various units of the device;

[0067] 3. Controlling the syringe motor 234;

[0068] 4. Controlling the provision of saline to the syringe;

[0069] 5. Providing audible signals;

[0070] 6. Controlling timing of the electrical signals so that they will be synchronized relative to each other.

[0071] In an exemplary embodiment of the invention, the DC signal may provide different amounts of current for different lengths of time depending upon the position being treated in the skin, for example when treating muscles and muscle nerves control 218 may apply a direct current of 1-2 milliamp for the duration of 0-30 seconds, whereas when treating fat in the subcutaneous level a direct current of 0.1-0.8 milliamps for 5-15 seconds may be used.

[0072] In an exemplary embodiment of the invention, handpiece 220 includes a needle positioning motor 270. Optionally, needle positioning motor 270 automatically positions the X-Y-Z coordinates of the needle relative to handpiece 220, so that the needle can be accurately and automatically controlled when handpiece 220 is held stationary. The use of needle positioning motor 270 allows better accuracy than achievable by a practitioner moving handpiece 220 manually.

[0073] In an exemplary embodiment of the invention, more than one needle 240 may be used to increase the number of points that are treated simultaneously. FIG. 3 is a schematic illustration of an alternative hand piece 300 with an array of needles 340, according to an exemplary embodiment of the invention. Optionally, array 340 may be provided in any shape and with any number of needles. Optionally, the needles may be equally spaced or unequally spaced. Additionally, the needles may form a symmetrical pattern or a non-symmetrical pattern. In some embodiments of the invention, each needle may be controlled separately or groups of needles from the array may be controlled together to form specific treatment patterns.

[0074] FIG. 4 is a schematic illustration summarizing a cosmetic skin treatment process 400 using device 200, according to an exemplary embodiment of the invention. As shown in FIG. 4 initially the user deploys (410) needle 240 to the desired depth in a person's skin 100. The desired depth may depend on the type of treatment being performed and/or on the area of the body being treated, for example epidermis 20 in the face and neck is 100 microns thick and dermis 30 is 1900 microns thick. In other parts of the body the epidermis and dermis may be thicker or less thick than these values. Optionally, needle 240 is designed to allow penetration of about 1-12 mm Optionally, device 200 provides the user with an indication of the position in the skin 100 based on the measured resistance between the cathode and the anode. Alternatively or additionally, the user is required to recognize the depth to which needle 240 is deployed based on human anatomy. Once needle 240 is positioned the user may apply (420) a negative DC voltage to needle 240 for a pre-selected length of time with a pre-selected level of current, for example the voltage may be between 1 to 40 Volts, current between 0.1 to 1 milliamp and time may be between 1 to 1 to 30 seconds. In an exemplary embodiment of the invention, the user sets selection dials 212 to select the desired parameters and have them applied automatically and accurately by device 100 when pressing an activation button after deploying needle 240.

[0075] In an exemplary embodiment of the invention, the penetration depth is determined by measuring the current or resistance of the circuit, since the resistance varies depending on the penetration depth or tissue layer. In some embodiments of the invention, the resistance is measured before treatment and after treatment to determine the level of success in damaging the targeted area.

[0076] In an exemplary embodiment of the invention, the parameters applied during the treatment depend upon many attributes, for example:

[0077] 1. The type of skin flaw being treated (e.g. stains, wrinkles, scars, keloids, fat, tattoos);

[0078] 2. The tolerance to pain of the person being treated;

[0079] 3. The skin and tissue sensitivity of the person being treated;

[0080] 4. The area being treated;

[0081] Optionally, the user may instruct device 200 to add Saline (430) or other liquids to enhance the success of the treatment. The DC voltage causes electrolysis to take place at the point of contact of needle 240 in the person's skin 100. The electrolysis releases Sodium and Hydroxyl Ions that are attracted to needle 240 causing them to combine and form (440) an Alkali: Sodium Hydroxide (NaOH). The Sodium Hydroxide is caustic and destroys cells surrounding the point of contact. The Sodium Hydroxide will be formed as a drop at the tip of the needle or along the non-insulated length of the needle. As a result the process causes precise damage to the selected layer below the surface of skin 100 without leaving noticeable markings on the outer layer of skin 100.

[0082] In an exemplary embodiment of the invention, device 200 includes RF transmitters that produce radiation directed toward the area being treated causing heat to be applied (450) to the area being treated. Optionally, the RF transmitters transmit at frequencies between the range of 0.5 to 40 Mhz so that the radiation is felt as heat in the person's skin 100. Optionally the heat accelerates the production of Sodium Hydroxide and/or assist in destroying cells surrounding the point of contact.

[0083] In an exemplary embodiment of the invention, the destruction process is applied (460) for a pre-selected amount of time (e.g. based on the size of the area needed to be ablated). Optionally, needle 240 may be used as a suction to remove (470) unwanted fluids, for example melted fat. After treating a specific area the user may remove (480) the needle and move it to treat a new location. Optionally, if using array 340 a larger area may be treated simultaneously instead of a single point. In some cases it may be advantageous to quickly cover a larger area, although in other cases pin point accuracy may be desired.

[0084] In some embodiments of the invention, needle positioning motor 270 controls the movement of each needle or a group of needles. Optionally, needle positioning motor 270 is programmed to treat a specific area while automatically controlling the spatial (X-Y-Z) coordinates of needle 240.

[0085] FIG. 8A is a schematic illustration of a single injection needle 240 performing electrolysis, according to method 400 as described above. FIG. 8B is a schematic illustration of an array of injection needles 340 performing electrolysis, according to method 400 as described above. In FIG. 8A needle 240 is covered with an insulation 260 and the chemical process is limited to the non-insulated area at the tip of needle 240. In contrast in FIG. 8B the needles of array 340 are not insulated so the chemical process occurs along the length of the needles in the skin, limited by the moisture gradient, wherein the deeper layers are moister than the upper layers so that more Sodium Hydroxide forms at the lower layers.

[0086] In some embodiments of the invention, device 200 and process 400 is applied to the ablation of muscles 50 and muscle nerve cells, for example as a substitute to using Botox to remove wrinkles from a person's forehead or from other places on the face or body of the person. Optionally, damaging muscles 50 and muscle nerve cells will have the effect of causing muscle 50 to lapse, like when using Botox but without the need to apply toxic materials. Alternatively or additionally, Botox may be applied (e.g. through the hollow of needle 240), for example in a smaller amount, while using the above process. Optionally, Botox may be applied in addition to the application of Saline. In some embodiments of the invention, other materials may be used for example medication to prevent infection.

[0087] FIG. 5 is a schematic illustration of a side sectional view of skin 100 with needle 240 deployed for treating muscles 50 below the subcutaneous layer 40, according to an exemplary embodiment of the invention.

[0088] In some embodiments of the invention, device 200 and process 400 may be applied to the reduction of fat cells from the subcutaneous layer 40. Optionally, needle 240 may be used without insulation 260 or with less insulation to expand the area that is affected by the DC current. Optionally, this process may be used to perform liposuction. In an exemplary embodiment of the invention, needle 240 is positioned in the person's skin 100 and used to melt down fat cells. The fat cells are emulsified into an oily liquid substance, and are disposed of by the natural body waste disposal processes. Optionally, the hollow of needle 240 is used to suck out the melted cells. In some embodiments of the invention, the hollow of needle 240 is used to inject medication, for example a Tumescent solution that consists of Lidocaine and Epinephrine. Lidocaine serves as a local anesthetic and Epinephrine leads to the constriction of blood vessels leading to less blood loss and less bruising. Optionally, the use of needle 240 with DC current may reduce the need to use medication or even cancel the need.

[0089] FIG. 6 is a schematic illustration of a side sectional view of skin 100 with needle 240 deployed for treating fatty areas in the subcutaneous layer, according to an exemplary embodiment of the invention.

[0090] In some embodiments of the invention, device 200 and process 400 may be applied to damage collagen fibers from the dermis 30. Optionally, needle 240 is inserted onto collagen fibers 70 and used to destroy them. The damage in the dermis 30 stimulates the body's natural healing process to produce new healthier skin 100 and collagen 70. In some embodiments of the invention, the heat produced by RF transmitters 232 results in collagen contraction leading to collagen regeneration and skin tightening. The combined effect of collagen contraction and wound healing rejuvenates skin 100. The fact that the ablation is pin pointed and the damaged areas are surrounded by healthy tissue speeds up the healing process and minimizes downtime of the person being treated.

[0091] FIG. 7 is a schematic illustration of a side sectional view of skin 100 with needle 240 deployed for treating collagen 70 in the dermal layer, according to an exemplary embodiment of the invention.

[0092] In an exemplary embodiment of the invention, the fact that the moisture gradient in skin tissue layers is such that moisture concentration is higher in the deeper layers minimizes the damage to the upper skin layers whether the upper part of needle 240 is covered by insulation 260 or not. Optionally, the skin surface will show no signs of the chemical process except the needle entry mark. Thus even when using the array of needles 340 or inserting needle 240 multiple times, skin 100 will show very little signs of treatment unless specifically aiming for the upper layer and using saline to enhance the process. In contrast a method that uses needles charged with AC current tends to cause excessive heating during treatment and leaves scar marks due to fat emulsification.

[0093] In an exemplary embodiment of the invention, treatment of the inner layers of skin 100 by the above methods cause the skin to become temporarily red with mild swelling but does not lead to skin peeling or require patient downtime.

[0094] In an exemplary embodiment of the invention, a number of experiments were conducted to test certain aspects of the device and methods described above.

[0095] In a first experiment the efficiency of the above method was tested by examining the effect on egg white.

[0096] An egg white of a fresh egg was placed inside a glass jar. Two electrodes were glued to two opposite inner walls of the jar. The electrodes were connected to an AC current supply generator of 1 MHz frequency and a power of approximately 5 Watt.

[0097] A third electrode was connected to the positive pole of a DC current source. This electrode was inserted into the jar. A fourth electrode was connected at one side to a needle such as used for hair removal by epilation. The needle diameter was 0.003 inch; manufactured by Ballet, model F3. The other side of the electrode was connected to the negatively charged (cathode) pole of the DC source.

[0098] In the first stage of the experiment only DC current was applied. This caused initial destruction of the egg white surrounding the needle. The time duration was measured from activation of the DC current until the formation of a white layer of dead cells around the needle.

[0099] In the second stage of the experiment, both DC and AC current were applied simultaneously. This caused initial destruction of the egg white surrounding the needle. Again, time duration was measured from the current activation until the formation of a white layer of dead cells around the needle.

[0100] The time duration measured in the first stage was found to be 2-4 times longer than the time measured in the second stage. Another observation concluded that the amount of dead cells surrounding the needle tip was significantly larger than the amount of dead cells along the needle.

[0101] In a second experiment the above methods were tested on animal tissue (flesh and fat) when applying combined currents, DC and/or AC, with or without saline solution injection.

[0102] Pork bacon slices were placed on a glass plate. A video camera was placed beneath the glass plate and the experiment was video filmed. A DC current operating at a voltage of V volts and a current intensity of A milliamp was used. A Dermatic 1 mesotherapy gun from Euromi with a syringe, catheters and non-insulated needles were used to perform the experiment. The negative (cathode) electrode of the DC source was connected to the syringe needle. The positive (anode) electrode of the DC source was connected to the mesotherapy gun in order to close the electric loop. An AC current source operating at a frequency of 1 MHz and a power of W was used. The AC current was used to create an RF radiation field between two electrodes attached to the pork slice. The mesotherapy syringe needle was injected into the slice between the two AC electrodes. The mesotherapy syringe needle was injected into the slice at a penetration depth of approximately 1-2 mm for a duration time of up to 1 minute. The mesotherapy gun contained saline solution for injection into the slice.

[0103] The following scenarios were examined:

[0104] 1. Syringe needle injection with no saline solution, no DC current, no AC current;

[0105] 2. Syringe needle injection with no saline solution, with DC current, no AC current;

[0106] 3. Syringe needle injection with saline solution, with DC current, no AC current;

[0107] 4. Syringe needle injection with no saline solution, with DC current, with AC current;

[0108] 5. Syringe needle injection with saline solution, with DC current, with AC current.

[0109] The following results were observed:

[0110] 1. Scenario 1—No effect on slice except the forming of a needle hole.

[0111] 2. Scenario 2—The DC current flowing through the needle caused a chemical reaction in the slice. A small region surrounding the needle was emulsified into oily liquid. A hole was formed in the tissue where it was emulsified. The process took approximately 1 minute. In viewing the video recording it can be seen that the initial effect is fat emulsification into liquid. In the next stage emulsification results in a small hole in the tissue which eventually grows larger and larger.

[0112] 3. Scenario 3—Injection of saline solution into the slice intensified the chemical reaction. Emulsification occurred faster and on a larger scale creating a larger region of emulsification surrounding the needle. A hole was formed in the tissue where the tissue was emulsified.

[0113] 4. Scenario 4—The AC current intensified the chemical reaction dramatically causing much faster emulsification and on a larger region surrounding the needle.

[0114] 5. Scenario 5—Injection of saline solution into the slice intensified the chemical reaction. Emulsification occurred faster and on a larger region. A hole was formed in the tissue where the tissue had emulsified. In this scenario the effect was the most profound.

CONCLUSIONS

[0115] The most effective method for emulsifying flesh and fat is using scenario 5which gave the most dramatic effect. The flesh and fat should be moist. Saline solution may be injected into the treated area in order to moisten the area. The injected needle should be charged with a negative DC current and the surrounding treatment zone should be radiated by a high frequency AC signal.

[0116] It should be appreciated that the above described methods and apparatus may be varied in many ways, including omitting or adding steps, changing the order of steps and the type of devices used. It should be appreciated that different features may be combined in different ways. In particular, not all the features shown above in a particular embodiment are necessary in every embodiment of the invention. Further combinations of the above features are also considered to be within the scope of some embodiments of the invention.

[0117] It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined only by the claims, which follow.