ELECTRICALLY BASED MEDICAL TREATMENT DEVICE AND METHOD

Abstract

Embodiments of medical treatment including skin treatment using electrical energy, especially with the primary purpose for skin treatment for aesthetics are described generally herein. Other embodiments may be described and claimed.

Claims

1-20. (cancel)

21. A mammalian body treatment apparatus, comprising: a plurality of electrodes, the electrodes configured to be deployable into a body segment to be treated; and a radio frequency (RF) generation module, the RF generation module electrically couplable to the plurality of electrodes and configured to apply an RF signal to the plurality of electrodes to cause the nearest electrodes of the plurality of electrodes to have periodically alternating opposite polarities and energy to be substantially applied to body segments around each electrode.

22. The mammalian body treatment apparatus of claim 21, wherein the RF generation module applies an RF signal with oscillating current to the plurality of electrodes to cause the nearest electrodes of the plurality of electrodes to have periodically alternating opposite polarities.

23. The mammalian body treatment apparatus of claim 21, wherein the RF generation module is configured to apply an RF signal to the plurality of electrodes for a predetermined time interval.

24. The mammalian body treatment apparatus of claim 21, further comprising a drive module to controllably move the plurality of electrodes into a body segment to be treated and a user interface to enable a user to select the depths that the drive module controllably moves the plurality of electrodes into a body segment to be treated.

25. The mammalian body treatment apparatus of claim 21, wherein the electrodes are bipolar.

26. The mammalian body treatment apparatus of claim 21, wherein the plurality of electrodes is arranged into a plurality of rows and columns and the RF signal generator applies an RF signal to the plurality of electrodes to cause the neighboring electrodes in each of the plurality of rows columns to have periodically alternating opposite polarities.

27. The mammalian body treatment apparatus of claim 21, wherein the plurality of electrodes forms a square configuration.

28. The mammalian body treatment apparatus of claim 21, wherein the plurality of electrodes forms a rectangular configuration and the RF signal generator applies an RF signal to the plurality of electrodes to cause the electrodes to have periodically alternating opposite polarities to form a checkboard pattern.

29. The mammalian body treatment apparatus of claim 21, wherein the plurality of electrodes are non-insulated.

30. The mammalian body treatment apparatus of claim 21, wherein each electrode of the plurality of electrodes is insulated except at its tip.

31. A method of treating a mammalian body, comprising: deploying a plurality of electrodes into a body segment to be treated; and applying an RF signal to the plurality of electrodes to cause the nearest electrodes of the plurality of electrodes to have periodically alternating opposite polarities and energy to be substantially applied to body segments around each electrode.

32. The method of treating a mammalian body of claim 31, including applying an RF signal with oscillating current to the plurality of electrodes to cause the nearest electrodes of the plurality of electrodes to have periodically alternating opposite polarities.

33. The method of treating a mammalian body of claim 31, including applying an RF signal to the plurality of electrodes for a predetermined time interval.

34. The method of treating a mammalian body of claim 31, including employing a drive module to controllably move the plurality of electrodes into a body segment to be treated and employing a user interface to enable a user to select the depths that the drive module controllably moves the plurality of electrodes into a body segment to be treated.

35. The method of treating a mammalian body of claim 31, wherein the electrodes are bipolar.

36. The method of treating a mammalian body of claim 31, wherein the plurality of electrodes is arranged into a plurality of rows and columns and applying an RF signal to the plurality of electrodes to cause the neighboring electrodes in each of the plurality of rows columns to have periodically alternating opposite polarities.

37. The method of treating a mammalian body of claim 31, wherein the plurality of electrodes forms a square configuration.

38. The method of treating a mammalian body of claim 31, wherein the plurality of electrodes forms a rectangular configuration and applying an RF signal to the plurality of electrodes to cause the electrodes to have periodically alternating opposite polarities to form a checkboard pattern.

39. The method of treating a mammalian body of claim 31, wherein the plurality of electrodes are non-insulated.

40. The method of treating a mammalian body of claim 31, wherein each electrode of the plurality of electrodes is insulated except at its tip.

Description

BRIEF EXPLANATIONS OF THE DRAWINGS

[0027] FIG. 1 is a block diagram of an apparatus according to an embodiment of the present invention.

[0028] FIG. 2 is a simplified diagram of treatment architecture using monopole needles according to an embodiment of the present invention.

[0029] FIG. 3 is a simplified diagram of treatment architecture using non-insulated bipolar needles according to an embodiment of the present invention.

[0030] FIG. 4 is a simplified diagram of treatment architecture using bipolar needles that are insulated except at the needle tip according to an embodiment of the present invention.

[0031] FIG. 5 is a simplified diagram of treatment architecture using non insulated needles according to an embodiment of the present invention.

[0032] FIG. 6 is a simplified diagram of a treatment architecture illustrating a polarity change of needles according to according to an embodiment of the present invention.

[0033] FIG. 7 is a simplified diagram of a treatment architecture according to an embodiment of the present invention.

[0034] FIG. 8 is a simplified diagram of a treatment architecture according to an embodiment of the present invention.

[0035] FIG. 9A is a simplified diagram of a treatment architecture according to an embodiment of the present invention with overlapping or intersecting energy fields..

[0036] FIG. 9B is a simplified diagram of a treatment architecture according to an embodiment of the present invention with non-overlapping or non-intersecting energy fields.

[0037] FIG. 10 is a simplified diagram of a treatment architecture illustrating a polarity change of needles according to according to an embodiment of the present invention.

[0038] FIG. 11 is a simplified diagram illustrating the distance between two needles according to various embodiments of the present invention.

DETAILED DESCRIPTION

[0039] The following is to explain an embodiment of this invention in detail.

TABLE-US-00001 Table of References Number Description 100: fixture holding needles 200: skin 201: epidermis 202: dermis 300: pin/needle/electrode 301: needle area penetrating skin 302: end of needle area penetrating into dermis 400: patient's hand receiving treatment using monopole method 500, 600: electrical wire 700: insulated area of needle 901: area where the temperature is raised when using monopole electrode 902: area where the temperature is raised when using non-insulated bipolar needles 903: area where the temperature is raised using insulated needles with non-insulated tips 909, 919, area where the temperature is raised using non-insulated 929: needles. 939, 949: area where the temperature is raised using partially insulated needles in epidermis.

[0040] This invention pursues multiple embodiments, where the embodiments may be related. Technological components of various embodiments may be similar. Embodiments may vary based on voltage, current, application time, needle thickness, resistance, AC frequency, high frequency, conductivity, and needle penetration depth. FIG. 1 is a block diagram a system 10 according to various embodiments. As shown in FIG. 1, the system 10 may include a power supply 12, an RF generator 14, a user input 16, a central processing unit 18, a user detectable output display 22, and a device (tip) 100 with a plurality of needles 300. The power supply 12 may provide required energy to the radio frequency (RF) generator 14. A user input device 16 may enable a user to set several parameters that control the energy field 909 generated about needles 300 in the tip or device 100 including the voltage, current, and frequency applied to the needles 300, the on time and off time of the RF signal during the cycles, the deployed depth of the needles (to treat a body region including epidermis, dermis, and subcutaneous sections of skin). The input device may be any device enabling a user to select various parameters including a keyboard, touch screen, or other user input device.

[0041] The system 10 output device 22 may be any user detectable output device including a user readable screen, light(s), and audio generation devices. The CPU 18 may receive the user selected parameters for the device 100 operation and control the operation of the RF generator 14 based on the user selected parameters. The CPU 18 may also provide a signal to generate an output signal displayable by the output device 22, the output signal indicating the operational state of the system 100 according to various embodiments. The RF generator 14 may generate signal or signal(s) having a desired voltage, current, energy, resistance, RF frequency, on cycle, off cycle, and other parameters according to various embodiments.

[0042] Some embodiments may employ bipolar needles, AC and high frequency signals. The distance between needles may vary for different embodiments. In an embodiment needles 301 (FIG. 2) may not be located close proximity because if the distance between electrodes or needles is too close, the energy field and the heated area generated by the applied energy field about each needle may be connected or intersect. In another embodiment the energy fields (generating heated areas in dermis) may be expanded and connected in dermis, but not in epidermis as shown in FIGS. 7 and 8.

[0043] In an embodiment, alternating current (AC) is the current that changes magnitude and direction periodically and may be a known waveform including a sine wave, triangular, or square wave. AC has characteristics that differ from direct current (DC), which flows in one direction and has a constant polarity. On-grid AC provided by power companies commonly alternates polarity about either at 50 Hz or 60 Hz worldwide.

[0044] In an embodiment, actuating needles with AC may be a factor to generate a desired effect or energy field about the each needle. In an embodiment, the AC frequency may be be hundreds of Hz to achieve the desired effect. For high frequency AC sources, the distance between needles may be decreased to compensate for the effect of the high frequency AC source. Low frequency AC sources may affect operation in an embodiment. AC sources having a frequency of 20 Hz or higher may not create a desired operation in an embodiment by controlling other factors. Those control factors are discussed below. In an embodiment, high frequency AC sources may be employed versus low and medium frequencies, and ultrasonic waves or sources.

[0045] In an embodiment the AC source may have a frequency above 0.5 MHz and about 2 MHz in another embodiment. Other embodiments may employ an AC signal having a frequency from 0.5 to 10 MHz, 1 to 4 MHz, and 1.5-2.5 MHz where the AC frequency selected range may vary depending on other operating factors that affect desired performance.

[0046] During electricity conductivity tests for dry skin and wet skin with AC signals having frequencies of 2 MHz and 1 MHz, it was noted that dry skin had a conductance of about 0.037102 at 2 MHz and about 0.013237 at 1 MHz and wet skin had a conductance of about 0.26649 at 2 MHz and about 0.2214 at 1 MHz. Consequently, RF energy flow or conductance may be smoother or less resistive when applied to wet skin at 2 MHz. Based on the lower conductance the probability for sparking for energy applied at 1 MHz (ignoring other variables) may be three times higher than 2 MHz energy.

[0047] In an embodiment a high frequency applied current may create an energy field closer to an electrode or needle than an equivalent energy low frequency current.

[0048] For example, when AC signals having a frequency below 0.5 MHz are applied to a needle or electrode the area impacted by the resultant, broad energy field may cause scaring in adjacent epidermis due to overheating regardless of electrode or needle spacing. Accordingly, for areas where a precise treatment is required such as around eyelid, the source frequency may be selected to prevent a broad energy field formation about the needles or electrodes to prevent a harmful impact on an eye. It is noted that when the source energy frequency is 10 MHz or above, the energy field formed about the needles or electrodes may be too narrow and thereby increase treatment time to achieve a desired therapy

[0049] In various embodiments, achieving a desired therapy may be related to the distance between deployed needles. For example, as the distance between needles decreases the source frequency value may be increased and conversely, as the distance between needles increases, the source frequency value may be decreased to achieve or limit the energy field formation about energized needles or electrodes. In an embodiment, adjacent needles are spaced about 2 mm apart when the needle energizing signal has a frequency of about 2 MHz.

[0050] In an embodiment, energized needles may be completely electrically insulated, un-insulated, and only insulated near its tip. Needle insulation may not be necessary fin an embodiment to achieve a desired energy field about the needle, in particular so the temperature is raised about the needle tip and the energy field forms an oval or tear shape in the adjacent dermis while the temperature is minimally raised in the epidermis, as shown in FIGS. 5, 7, 8 and 9B. However, non-electrical insulation coating may not affect energy field formation in about embodiment as shown in FIG. 9B. In an embodiment, needles may be plated with other precious metals or heat-treated to modify needle or electrode conductivity and hardness.

[0051] In an embodiment, the needles may not be insulated. In embodiments where at least a portion of the needle is insulated, the segment or area of needle that is configured to contact the dermis may not be insulated. In an embodiment, the entire needle to be energized may be insulated while generating a desired energy field about the needle in the dermis. In an embodiment, a monopole needle insulated except for its tip may be employed to achieve an energy field with a desired shape and temperature. It is important to note that the similarity in energy field shape may have a different effect depending the method applied.

[0052] In an embodiment, different needle arrangements may be employed. In one embodiment, neighboring or adjacent needles 300 may be configured to have opposite polarities as shown in FIG. 6. As shown in FIG. 6, a needle configuration 100 may include needles 300 arranged in a rectangular shape where needles on each corner are configured to have a polarity opposite its adjacent or neighboring needles. In an embodiment, different AC signals having opposite polarities may be applied to needles 300 designated (+) and (−). Because of AC signal characteristics, the polarity of each needle may change many times per second (up to 10 MhZ in an embodiment) and cause a needle 300 polarity to change as shown in FIG. 6 at applied AC signal rate. In an embodiment, each needle is configured to have a polarity that is opposite to its closest neighboring needles, polarity shown as in (+) and (−) in FIG. 6 due to the signals applied to the needles 300 via the RF signal generator 14 (FIG. 1).

[0053] In an embodiment, a needle 300 cross-section may be configured in a square shape 100 (see FIG. 11). In other embodiments, the needles 300 may be configured in the shape of a rhombus, rectangle, circle, oval, or quadrangle (see FIG. 11). In an embodiment, regardless of shape, the neighboring needles may be configured to have opposite polarities when signals are applied by the RF signal generator 14 (FIG. 1).

[0054] In an embodiment, one or more needles 100 may be non-conductive, not energized, or physically removed from particular positions and still produce desired energy fields about the needles in the desired anatomy. In an embodiment, each, closest neighboring needles have opposite polarities, crossing in each direction as in (+) and (−), and a form a square shape 100 having sixteen needles 300.

[0055] FIG. 10 is a simplified diagram 100 of another needle 300 arrangement 100 according to various embodiments. In an embodiment, the polarity of needles 300 may be configured to change with every two, adjacent needles to form a pattern of (−) (−) (+) (+). In another embodiment, two or more needles may have the same polarity and then next set has an opposite polarity based on the signals applied to the needles 300. A variety of needle 300 polarity combinations, placements, and needle shapes 100 may be used in designing a device that generates a desired energy field about a needle 300 including the configurations shown in FIG. 6 and FIG. 10.

[0056] In an embodiment, a device or needle configuration 100 may have a minimum number of needles is 4. In another embodiment, a device or needle configuration may have a minimum of 9 needles with the polarity arrangement shown in FIG. 6 or FIG. 10.

[0057] As noted above other needle arrangements can be configured according to various embodiments where the needles produce a desired energy field about the needle.

[0058] In order to generate a desired energy field 909 (FIG. 5), 949 (FIG. 9B) about one or more needle 300 tips 302, an embodiment of the present invention may regulate voltage to be applied to a needle in addition to polarity, pattern, shape, adjacent distance, and frequency. In an embodiment, the voltage level applied to one or more needles 300 may determine or be a factor in setting the distance between needles 300 and ensuring safety of a device including the needles 300. In an embodiment, the voltage applied to skin may be measured.

[0059] In an embodiment he meaning of “the applied voltage to skin” may be the actual voltage applied to skin between the surface of a needle and the skin the needle contacts. The actual voltage value as applied to the skin may vary on device resistance, needle resistance and skin resistance at different needle positions. The voltage applied to a needle may be different to the voltage actually applied to the skin due to the skin resistance.

[0060] Skin resistance values may vary sub-dermally, but negligibly. It is noted that the applied voltage may be directly related to the amount of energy created at a needle. In an embodiment, the voltage applied to a needle or electrode may not exceed 100V with a recommended operating range between 10 to 60V and about 20 to 40V in a particular embodiment. In an embodiment, voltages above 100V may be applied, but there may cause skin overheating or burning so such voltages may not be recommended for use as the operating voltage for skin treatment. The actual skin voltage and the device operating voltage may be controlled by in an embodiment of the present invention. Given a relatively constant skin resistance, controlling the voltage applied to a needle 300 or group of needles 100 may also control the current flowing in the needle and the skin adjacent to the needle. In particular, the electric current may vary depending on voltage and resistance, but it is possible to compute the value of the electric current when device resistance, needle resistance, and skin resistance values are determined based on the equation:

V=I*R

[0061] A systems resistance may be related to device resistance 100, needle resistance 300, and skin 200 resistance in an embodiment.

[0062] In order to generate a desired energy field 909, 949 about one or more needle 300 tips 302, an embodiment of the present invention may regulate the energy duty cycle. In an embodiment a system 100 may take a minimum of 0.02 seconds for high frequency energy to reach its stability so a desired energy field 909, 949 is achieved about a needle 302. If the energy duration or cycle is less than 0.02 seconds, a desired energy field 909, 949 may not be achieved in an embodiment. In an embodiment, the minimum duty cycle was set to be 0.5 seconds or greater. A major advantage of this embodiment is the relatively short energy retention or duty cycle with a longest retention time about 0.8 seconds. In another embodiment the energy retention time or duty cycle may be increased by increasing the distance between needles 300 and lowering the applied voltage. In an embodiment the energy retention time or duty cycle is between 0.05 to 0.8 seconds.

[0063] An optimal duty cycle, on time, or retention time or delay between cycles is not intuitive given it is relatively short. In an embodiment an acceptable energy delivery delay may be between 0.1 to 0.4 seconds, with a range from 0.1 to 0.2 seconds in another embodiment. It was discovered that using high frequency and low voltage signals applied to needles 300 having a desired spacing created an energy field that enables effective skin treatment. In an embodiment a desirable delay time may be between 0.1-0.4 seconds and as about 0.1-0.2 seconds in a particular embodiment. Determining the parameters to enable the desired energy field according the present invention required countless trials and errors with insight. After developing the embodiments to form the desired energy field, it is possible to use a short load time in conjunction with a high frequency, low voltage, and alternating current signal.

[0064] Some existing systems may apply high voltage signals with an on time greater 0.5 seconds to skin via electrodes versus embodiments of the present invention that generate signals having a shorter on time.

[0065] In order to generate a desired energy field 909, 949 about one or more needle 300 tips 302, an embodiment of the present invention may employ needles with particular lengths and thicknesses. Needle thickness may vary with needle distance in an embodiment. In an embodiment a needle should be thick enough and made of a material strong enough to withstand repetitive penetrations into a body region, skin in an embodiment. An embodiment may need to balance thickness with possible patient pain and scars.

[0066] In an embodiment, a needle may have a diameter or outer profile of about 0.25 mm and 0.30 mm but is not critical to achieve desired energy fields 909, 949. The needle length may also vary depending on the thickness of the body region (skin in embodiment) to be treated and the type of treatment. In general, epidermis depth may be between 0.2 mm and 1 mm and dermis depth may be between 1 mm and 4 mm (from the skin boundary). In an embodiment a needle may configured to reach at least the top of the dermis, at least 0.2 mm in length in an embodiment and have a maximum length of about 5 mm to reach or penetrate to the dermis center or bottom. To ensure safe use in an embodiment a needle length may enable an ideal treatment depth from 1 mm-5 mm. In an embodiment, a needle total length may vary on the device 100, with a range between 1 mm to 4 mm.

[0067] Epidermis consists of stratum corneum, stratum granulosum, stratum spinosum, stratum basale, each with a potentially different resistance level. Epidermis may be treated with a device 100 having needles 300 with a length of about 1 mm. Another device 100 according to various embodiments may employ needles have a length of about 6 mm to treat skin's subcutaneous layer. Accordingly in an embodiment a device 100 may employ a needle that penetrates to a depth between lmm to 6 mm.

[0068] In order to generate a desired energy field 909, 949 about one or more needle 300 tips 302, an embodiment of the present invention may employ needles having a desired distance and shape including the shapes shown in FIG. 11. In an embodiment, the minimum distance between adjacent needles may be about 1.3 mm. In another embodiment, the distance between adjacent needles may be between 1.3-3.0 mm where the needle signal current or needle resistance may be varied based on needle distance while enabling a desired energy field to be formed about the needles.

[0069] In an embodiment where the distance between closest neighboring needles is shorter than 1.3 mm, there may be a risk of overheating or scaring. In an embodiment, where the distance between adjacent needles is greater than 3.0 mm, needle activation times may increases in order to achieve the same desired results as the treatment efficiency may decrease significantly. It is noted that the distance between adjacent needles may vary as function of the multiple variables discussed above.

[0070] In an embodiment other device operation factors that may vary as a function of the distance between needles including energy level (current, voltage), and a needle's thickness (outer diameter). For example, as the applied energy increases, the needle thickness may increases, the distance between adjacent needles may also be expanded to achieve a desired energy field about the needle(s). It is noted that applied energy is equal to voltage (V) multiplied by current (I) and time (t) (V*I*t).

[0071] In another embodiment the distance between adjacent needles may be reduced when the system resistance, AC frequency rate, high frequency rate, and needle length or needle depth increases in any combination. In an embodiment, the distance between adjacent needles may be determined as follows:

[0072] Distance=N*(Power=energy)*(Needle Thickness)* (Conductivity)/(Resistance)*(AC Frequency)*(High Frequency)*(Penetrated Needle Depth)

[0073] Where:

[0074] N: A proportional constant, Resistance: Device resistance, needle resistance, skin resistance

[0075] Energy (Joule)=W*t(W=Watt, t=time)

[0076] Energy (Joule)=V*I*t(W=V*I)

[0077] Energy (Joule)=I^2*R*t(V=I*R)

[0078] Substituting Energy for V*I*t, the distance between adjacent needles may be determined as follows:

[0079] Distance=N*V*I*t*(Needle Thickness)*(Conductivity)/(Resistance)* (AC Frequency)*(High Frequency)*(Penetrated Needle Depth)

[0080] Other distance calculations are possible according to various embodiments. In an embodiment, a device's 100 needles 300 may fixed (distance between adjacent needles) but may move freely axially to enable movement within a confined space of the device 100.