AUTOMATED MEASUREMENT AND CONTROL SYSTEM FOR TATTOO DELIVERY

Abstract

Tattooing, or delivery of pigment into the skin, producing temporary or permanent markings on the skin, is practiced for aesthetic and practical purposes. Human and mechanical control of tattooing may be augmented by sensors, coupled to an adaptive control system capable of improving the results, and relieving demands on the operator.

Claims

1. A tattooing device comprising one or more needles operative for moving pigment from a reservoir to the needle tip(s) for delivering pigment to the upper dermal layer of a selected location in the scalp of a patient, said device comprising one or more sensors for dynamically sensing changes in skin characteristics as said needle(s) penetrates the skin of the scalp, said sensor(s) being operative to signal the arrival of the needle tip(s) at the upper dermal layer of the selected location in the upper dermis.

2. A device as in claim 1 wherein said sensors comprise one or more of an electrical, pressure, temperature, sound or optical signals.

3. A device as in claim 1 comprising one or a plurality of hollow or solid core needles.

4. A device as in claim 1 comprising a microprocessor operative responsive to said signal(s) to determine the depth of penetration of said needle or needles and the dwell time of said needle or needles.

5. A device as in claim 4 wherein said device is adapted for penetrating the skin at a 45 degree angle or at a 90 degree angle.

6. A device as in claim 4 wherein said microprocessor is operative to control said depth of penetration and dwell time to deliver a prespecified amount of pigment to the selected location of the scalp at a depth of the upper fatty upper dermis at the selected location.

7. A device as in claim 3 adapted for human or robotic manipulation.

8. A device as in claim 4 comprising one or a plurality of hollow or solid needles adapted for human or robotic manipulation.

9. The device as in claim 4 wherein said device further comprises an actuator, needle injector, or a variable speed motor and a rotating cam follower and a screw adjustment to the needle extension operative to extend said one or more needles in response to said first signal or microprocessor output.

10. The device of claims 1 wherein the needle depth into the skin is between 0.3 mm-4.0 mm,

11. The device of claims 1 wherein the needle dwell time into the skin is between 1.0 seconds-0.005 seconds.

12. A device as in claim 4 comprising a plurality of needle assemblies, each of said needle assemblies comprising one or more needles, said microprocessor being operative to control the penetration and dwell times of each of said assemblies.

13. The device of claims 1 wherein the microprocessor utilizes feedback from a feel from a human hand or sensed by a robot operator to predetermine a precise delivery of pigment based upon a learning algorithm.

14. The method of delivering a prescribed amount of material through the skin and into the upper fatty dermis through a tattoo instrument, said method comprising the steps of: 1. advancing the tattoo instrument of claim 1 into the skin at a selected location; 2. observing the sensor(s) for depth limiting signal; 3. activating the tattoo instrument for delivering pigment through the needle or needles in the tattoo instrument when the depth-limiting signal occurs

15. The method of delivering a prescribed amount of material through the skin and into the upper fatty dermis through a tattoo instrument, said method comprising the steps of: 1. advancing the tattoo instrument of claim 14 into the skin at a selected location; 2. observing the sensor(s) for feedback from pressure, electrical, temperature, sound or optical signals indicating a volume of pigment; 3. activating the tattoo instrument for delivering pigment through the needle or needles in the tattoo instrument when the volume signal occurs which can limit the volume delivered dynamically.

16. The method of delivering a prescribed amount of material through the skin and into the upper fatty dermis through a tattoo instrument of claim 15, said method comprising the steps of: 1. advancing the tattoo instrument of claim 1 into the skin at a selected location; 2. wherein the sensor(s) is processed by a microprocessor; 3. activating the tattoo instrument for delivering pigment through the needle or needles in the tattoo instrument wherein the microprocessor control and adjusts the dwell time and/or the depth of the needle into the upper fatty dermis dynamically.

17. The method of delivering a prescribed amount of material through the skin and into the upper fatty dermis through a tattoo instrument of claim 16, said method comprising the steps of: 1. advancing the tattoo instrument of claim 1 into the skin at a selected location; 2. wherein the sensor(s) signals are processed by a microprocessor; 3. activating the tattoo instrument for delivering pigment through the needle or needles in the tattoo instrument further comprising an actuator, needle injector, or a van able speed motor and a rotating cam follower and a screw adjustment to the needle extension operative to (a) extend said one or more needles cyclically in response to said first signal, and/or (b) dynamically adjust the needle injector or variable speed motor and/or a rotating cam followers and screw adjustment to the needle to the sensor signals in response to the microprocessor output.

18. The method of delivering a prescribed amount of material through the skin and into the upper fatty dermis through a tattoo instrument of claim 15, said method comprising the steps of: 1. advancing the tattoo instrument of claim 1 into the skin at a selected location; 2. wherein the sensor(s) is processed by a microprocessor; 3. activating the tattoo instrument for delivering pigment through the needle or needles in the tattoo instrument, 4, delivering a precise amount of pigment to a patient's skin of claim 17 wherein (a) said method dynamically adjust the needle depth between 0.5 mm-4.0 mm in response to sensing signals and microprocessor output

19. The method of delivering a precise amount of pigment to a patient's skin of claim 16 wherein said method dynamically (a) adjusts the needle dwell time between 1 seconds-0.005 seconds to (b) deliver a specified amount of pigment.

20. The method of delivering a precise amount of pigment to a patient's skin of claimn 16 wherein said method adjusts the needle to (a) 45 degrees, to (b) 90 degrees or (c) to some needle angle relative to the skin between 45-90 degrees and adjust the delivery in response to a pressure signal, an electrical signal, a temperature signal, a sound signal, an optical signal or the output of a microprocessor to change the delivery of the pigment into the skin.

21. The method of delivering a prescribed amount of material through the skin and into the upper fatty dermis through a tattoo instrument of claim 16, said method comprising the steps of: 1. advancing the tattoo instrument of claim 1 into the skin at a selected location; 2. wherein the sensor(s) is processed by a microprocessor; 3. activating the tattoo instrument for delivering pigment through the needle or needles in the tattoo instrument operated by, (a) a human hand or (b) a robot either responsive to a pressure signal, an electrical signal, a temperature signal, a sound signal, optical signal or to a microprocessor output to change the delivery of the pigment into the skin.

22. The method of delivering a prescribed amount of material through the skin and into the upper fatty dermis through a tattoo instrument of claim 15, said method comprising the steps of: 1. advancing the tattoo instrument of claim 14 into the skin at a selected location; 2. wherein the sensor(s) is processed by a microprocessor; 3. activating the tattoo instrument for delivering pigment through the needle or needles in the tattoo instrument, wherein the microprocessor utilizes feedback from (a) a feel from a human hand or (b) sensed by a robot operator to predetermine a precise delivery of pigment based upon or (c) a learning algorithm, further adjusted by input of a pressure signal, an electrical signal, a temperature signal, a sound signal, or an optical signal to change the delivery of the quantity of pigment into the upper fatty dermis.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0058] FIG. 1 shows a schematic of a traditional tattoo apparatus including a simple electrical power source and handpiece.

[0059] FIG. 2 shows a photograph of a satisfactory dense and consistent scalp pigmentation result.

[0060] FIG. 3 shows a photograph of an unsatisfactory result including inconsistent size and density of stippling.

[0061] FIG. 4 shows a histology image of pigment particles in and among the fibroblasts at the dermis/epidermis border.

[0062] FIG. 5 shows a histology image of pigment particles diffused into the dermis.

[0063] FIG. 6 shows a schema for control, consisting of the four elements of the apparatus: the anatomy; the tattooing device, the electro-acoustic sensors and transducers; and the processing unit.

[0064] FIG. 7 shows an illustration of the phases of the method.

DETAILED DESCRIPTION

[0065] According to one aspect of an exemplary embodiment of the present invention, there is provided a tattooing apparatus, including tattoo needle(s) cycling back and forth into the skin to allow a pigment solution to penetrate beyond the epidermis and into the upper dermis for a given period of time and at a controlled depth. While referred to herein as a pigment solution it is understood that there are numerous commercially available inks and pigments for tattooing. It should also be understood that an inventive aspect of the invention is the incorporation of additional adjuvants such as collagen or collagen production stimulating chemicals, proteins or other naturally occurring collagen stimulants. Pigment solutions could have additional clinically beneficial levels of vitamins.

[0066] According to another aspect of an exemplary embodiment of the present invention, there is provided a tattooing apparatus, including a main body with a handle portion having a mechanical drive such as a motor therein and a series of needle(s) cycling for discharging tattoo pigment.

[0067] The tattooing apparatus may further include mechanical, electronic and acoustic sensing elements which can detect changes in the state of operation of the needle as a result of mechanical resistance from the cycling of the tattoo needle through the epidermis and into the upper dermis from among the following inputs: signals from an encoder for determining direction of rotation and position and a zero or index or reference signal encoder that counts revolutions/frequency, resistance, amperage, voltage, back-EMF velocity, radio-frequency emissions, and acoustic emissions. These encoder inputs work in cooperation to allow the needle to operate as having multiple sensors, primarily for determining relative resistance of needle movement as it relates to biomechanical properties of the skin. The encoder could utilize position sensing devices like gyros or accelerometers to help orient an operator.

[0068] The needle of the tattooing apparatus thus provided serve as a primary sensor for contact with the epidermis, the viscoelastic properties of the dermis, the depth of the dermis, and the degree to which skin has been repeatedly punctured when delivering ink. Each stroke of the needle as it goes through a cycle encountering different conditions produces a characteristic curve of mechanical, electrical and sonic feedback, and the frequency will be variably retarded by contact with materials of differing density and with different fractional drag on the needle, which may be monitored and analyzed by the encoders. Motors can be alternating current, direct current, coil, other commonly commercially available in today's tattoo devices.

[0069] In an alternative embodiment the device can be operated by a robot in lieu of a human operator. Robot operation is possible via communication between a microprocessor of a preferred embodiment with a robot capable of movement in three-axis about a patient scalp. In this alternative embodiment the operator could be a smart robot that could be positioned about a patients head. In this robot embodiment the device could scan the patients head and determine the proper orientation for delivering ink based on the previously described factors.

[0070] A processing unit is a computer, or a microprocessor such as Field Programmable Gate Arrays (“FPGA”), equipped with a user interface and algorithms capable of learning the ideal technique for each individual patient's anatomy from a human operator, and the processing unit is capable of adjusting the operation of the tattoo apparatus, including mechanical adjustments and delivery of power from the main body unit so as to maintain the needle depth at the proper position during any point in a cycle. Commercially available Xilinx Field Programmable Gate Arrays (FPGAs), holds multiple patents, and is the clear market leader in programmable logic in terms of both revenue and technology.

[0071] In a preferred embodiment a method consists of two phases, wherein a user first teaches a tattoo apparatus, and a second wherein the tattoo apparatus adaptively adjusts operational parameters to achieve the result desired consistently for the duration of the procedure based on the learning from the first phase. For example, during a first sampling phase an operator applies a small statistically significant sample, perhaps ten sites or spots, over a limited area, utilizing the operator's manual control of all parameters and a visual subjective judgment of success, while the tattoo apparatus encoders are collecting data on each cycle. The processing unit analyzes the inputs that include most significantly, depth of penetration of a needle, number of strokes at a correct depth, and withdrawal of the tattoo needle from the skin at the precise moment that the spot is optimally positioned. These inputs may then be processed by means of supervised learning algorithms well-established in the field of machine learning. This establishes and teaches the tattoo apparatus a norm or mean condition for the patient's skin as well as the necessary adaptive responses to conditions outside the norm or mean condition. During the delivery phase the tattoo apparatus collects data from the encoders during delivery of each spot, and using what the processing unit has learned, controls speed and/or force and depth of the needle stroke and the frequency of strokes to deliver the optimum amount of pigment solution at the optimum position. Also, the number and operation of the needles may operate independently. Furthermore there may be a vibrating element such as a piezoelectric crystal or small motor to serve as a second acoustic ping generator for monitoring a needle state, with similar drive sensing capabilities, and secondly to provide vibrations to generate destructive interference for the primary mechanical vibration.

[0072] Thus after the first phase, the first few strokes in a subsequent scalp location are used to sense and analyze, and the remaining needle strokes are adjusted to best address local scalp conditions. These factors in tandem with the operator's input during the first phase permit control of tattooing of each spot. For instance, if a spot has an area of thickened epidermis, the needle will encounter greater resistance than normal early in the stroke, just as the needle contacts and pierces the epidermis, detectable in the amplitude and/or period, followed by normal completion of the duration of the pierce/withdraw cycle. Upon sensing this changed condition, the processing unit can fit to the curve to determine the nature of the differing condition, and calculate the area of the difference or perturbance of the “normal” cycle, and adjust accordingly. Simple mechanical adjustments such as a cam follower or adjustable depth plate to deepen or change the duration of different phases of the stroke are well known in the mechanical engineering art, though not present in the field. In a preferred embodiment, additional electrical power may be supplied to the motor or the waveform of electrical power delivery may be adjusted, increasing the velocity of the needle to compensate for tougher anatomy. It should be understood that a needle cycle may also encompass a vibration motion that is not of a strictly vertical trajectory relative to the epidermis, for example side to side, circular or other patterns in a plane or with slight changes in vertical penetration and retraction of the needle relative to the skin surface.

[0073] The encoders described herein are not intended to be limited to the numerous commercially available types of sensors commercially available but are disclosed to aid in the enablement of the tattoo apparatus. Temperature sensors come in the form of thermocouples, resistance-temperature detectors, and thermistors. Thermistors differ from resistance temperature detectors (“RTDs”) in that the material used in a thermistor is generally a ceramic or polymer, while RTDs use pure metals. The temperature response is also different; RTDs are useful over larger temperature ranges, while thermistors typically achieve a higher precision within a limited temperature range, typically −90° C. to 130° C. Infrared sensors emit and/or detect infrared radiation to sense a particular phase in the environment. The infrared sensor may detect radiation differences between dermis with and without pigment embedded which is not visible to human eye. Similarly, ultraviolet (“UV”) sensors measure the intensity or power of the incident ultraviolet radiation. This form of electromagnetic radiation has wavelengths longer than x-rays but is still shorter than visible radiation. An active material known as polycrystalline diamond is being used for reliable ultraviolet sensing. UV sensors can measure how much pigment has been delivered to the dermis.

[0074] In another preferred embodiment ultrasonic or light sensitive transducers can measure thickness and density of the epidermis and differentiate it from the sub-dermal fat immediately below the epidermis. The needles themselves, will be made of a solid material which will easily be detected in relationship to the surrounding anatomy of all layers of the skin. These transducers can measure these solid needles as they move into and through the epidermis to the exact point at which the tattoo needles enter the sub-dermal space. As the pigment has a higher density than the fat in the sub-dermal space, the pigment can be visualized as it builds into an aggregate of some dimension. As the pigment is deposited in the sub-dermal space immediately below the epidermis, the pigment can be seen with ultrasonic or optical sensors as it accumulates in the sub-dermal space. Ultrasonic and/or optical sensors can measure the physical dimensions of the pigment aggregate deposited in the sub-dermal space because of these density differences between the fat (which has density close to water) and the pigment amalgam which will have a higher density than water and may contains minutes amounts of metallic molecules which will reflect both sound and/or light. By measuring both the point at which the needles penetrate the epidermis and the size of the pigment aggregate, precise feedback signals can be obtained to stop pigment deposition once the ideal depth and the aggregate size has been determined.

[0075] Today's pigments include the original mineral pigments, modern industrial organic pigments, a few vegetable-based pigments, and some plastic-based pigments. Allergic reactions, scarring, phototoxic reactions (i.e., reaction from exposure to light, especially sunlight), and other adverse effects are possible with many pigments.

[0076] Plastic-based pigments are very intensely colored, but many people have reported reactions to them. There are several pigments that glow in response to black (ultraviolet) light. These pigments are notoriously risky—some may be safe, but others are radioactive or otherwise toxic. The oldest natural pigments come from ground up minerals and carbon black (one of the main constituents of Indian Ink). Some of the minerals most commonly used as natural pigments are Mica (AKA pearlescent powder) Mica dust, and pearl pigments, both are cosmetic grade, and also approved by the FDA. Natural colorants are ideal cosmetic pigments they are water dispersible and about one teaspoon of colorant will easily color four pounds of soap. A wide range of bismuth oxychloride and liquid food coloring are used widely as cosmetic pigments.

[0077] Unnatural color pigments however yield a more intense color than natural cosmetic pigments and are water dispersible, transparent and blend well with soap. Pigment blends include yellow pigment blend made of titanium dioxide with FDA approved iron oxide, iron oxide brown and iron oxide red and red based pigment blend which contains titanium dioxide with FDA approved, iron ocher, iron oxide brown and iron oxide red.

[0078] In addition to the pigment Tattoo ink consists of a carrier. The carrier may be a single substance or a mixture. The purpose of the carrier is to keep the pigment evenly distributed in a fluid matrix, to inhibit the growth of pathogens, to prevent clumping of pigment, and to aid in application to the skin. Among the safest and most common ingredients used to make the liquid are: [0079] ethyl alcohol (ethanol) [0080] purified water [0081] witch hazel [0082] Listerine [0083] propylene glycol [0084] glycerine (glycerol)

[0085] A key consideration is that cosmetic pigments might oxidize and fade over a period of time and might require a touch ups. The application of pigment should always include a thorough knowledge of the shape selection, selection of techniques, pain and swelling control and conservative applications.

[0086] The table below lists colors of common pigments use in tattoo inks. It should be noted that many inks mix one or more pigment.sup.1: .sup.1http://chemistry.about.com/library/weekly/aa121602a.htm

TABLE-US-00001 Composition of Tattoo Pigments Color Materials Comment Black Iron Oxide (Fe3O4) Natural black pigment is made from magnetite crystals, powdered jet, Iron Oxide (FeO) wustite, bone black, and amorphous carbon from combustion (soot). Carbon Black pigment is commonly made into India ink. Logwood Logwood is a heartwood extract from Haematoxylon campechisnum, found in Central America and the West Indies. Brown Ochre Ochre is composed of iron (ferric) oxides mixed with clay. Raw ochre is yellowish. When dehydrated through heating, ochre changes to a reddish color. Red Cinnabar (HgS) Iron oxide is also known as common rust. Cinnabar and cadmium Cadmium Red (CdSe) pigments are highly toxic. Napthol reds are synthesized from Naptha. Iron Oxide (Fe2O3) Fewer reactions have been reported with naphthol red than the other Napthol-AS pigment pigments, but all reds carry risks of allergic or other reactions. Orange disazodiarylide and/or The organics are formed from the condensation of 2 monoazo pigment disazopyrazolone molecules. They are large molecules with good thermal stability and cadmium seleno-sulfide colorfastness. Flesh Ochres (iron oxides mixed with clay) Yellow Cadmium Yellow (CdS, Curcuma is derived from plants of the ginger family; aka tumeric or CdZnS) curcurmin. Reactions are commonly associated with yellow pigments, in Ochres part because more pigment is needed to achieve a bright color. Curcuma Yellow Chrome Yellow (PbCrO4, often mixed with PbS) disazodiarylide Green Chromium Oxide (Cr2O3), The greens often include admixtures, such as potassium ferrocyanide called Casalis Green or (yellow or red) and ferric ferrocyanide (Prussian Blue) Anadomis Green Malachite [Cu2(CO3)(OH)2] Ferrocyanides and Ferricyanides Lead chromate Monoazo pigment Cu/Al phthalocyanine Cu phthalocyanine Blue Azure Blue Blue pigments from minerals include copper (II) carbonate (azurite), Cobalt Blue sodium aluminum silicate (lapis lazuli), calcium copper silicate (Egyptian Cu-phthalocyanine Blue), other cobalt aluminum oxides and chromium oxides. The safest blues and greens are copper salts, such as copper pthalocyanine. Copper pthalocyanine pigments have FDA approval for use in infant furniture and toys and contact lenses. The copper-based pigments are considerably safer or more stable than cobalt or ultramarine pigments. Violet Manganese Violet Some of the purples, especially the bright magentas, are photoreactive (manganese ammonium and lose their color after prolonged exposure to light. Dioxazine and pyrophosphate) carbazole result in the most stable purple pigments. Various aluminum salts Quinacridone Dioxazine/carbazole White Lead White (Lead Carbonate) Titanium dioxide (TiO2) Barium Sulfate (BaSO4) Zinc Oxide

[0087] Various pigments have differing amounts of metallic pigments and it is understood that ultrasonic and/or optical pigment characteristics can be added, reduced or removed to optimize the sensitivity of the detector means. .sup.1http://chemistry.about.com/library/weekly/aa121602a.htm

[0088] Electrical sensors are inexpensive, accurate, and readily available in many designs. Electrical sensors can be directed towards current, voltage, or power.

[0089] Piezoelectric pressure sensors work under rapidly changing conditions and would be a preferable embodiment.

[0090] Ultrasonic transducers can measure thickness and density of skin.

[0091] Polarized and depolarized light can be used to visualize blood vessels and the anatomy of the skin.