Systems for use in tattoo application and removal, and other skin treatments
Patent Information
- Application Number
- JP2024539889
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-10-19
- Filing Date
- 2022-12-30
- Publication Date
- 2026-01-07
AI Technical Summary
Current tattoo removal methods are time-consuming and require extensive planning and marking to ensure proper spacing of treatment areas, leading to inconsistent results and potential scarring, while existing devices struggle with maintaining skin bridges for effective healing.
A system with programmable control elements for independent degrees of freedom, including mechanical brush movements and fluid flow, to automate tattoo removal and other skin treatments, using a reciprocating and rotating needle assembly with disposable cartridges for consistent treatment diameter and direction.
The system enables faster, more consistent tattoo removal and skin treatments by reducing reliance on technician skill, ensuring proper skin bridging, and minimizing scarring, while allowing for various treatment applications such as tattoo removal, scar correction, and skin tightening.
Smart Images

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Abstract
Description
[Technical field]
[0001] TECHNICAL FIELD The present invention relates generally to the application and removal of tattoos, and more particularly to the use of a reciprocating and rotating needle assembly.
[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 295,610, filed December 31, 2021, and U.S. Provisional Application No. 63 / 417,466, filed October 19, 2022, the contents of each of which are incorporated herein by reference. [Background technology]
[0003] Tattooing has been known for centuries. By placing a dye on the surface of the skin and puncturing the skin with a needle, the ink or dye is drawn into the wound made by the needle. The presence of the ink or dye in the wound stains the tissue, which takes on the color of the ink or dye injected into the skin during puncture. Once the wound heals, the ink that has been drawn into the dermal tissue, the extracellular matrix, and possibly some cells, permanently stains the cells and surrounding tissue structures, and the stained tissue becomes visible from outside the dermis.
[0004] Previously, the tattooing process was often a simple procedure performed with crude equipment, but over time, single-needle, hand-applied tattooing has been augmented by mechanically and electrically driven vibrating needle devices or linear drive needle devices. These devices allow the tattoo artist or technician to vary the rate at which the needle penetrates the skin, as well as control the depth to which the needle penetrates the skin. Similarly, inks and dyes have improved, allowing for the application of more skin-safe products with a greater variety of colors. Over time, as techniques improved, in some cultures, tattoos were applied over large areas of the client's body, and the way these tattoos were applied and presented was praised and admired.
[0005] Previous practice methods and environments increased the risk of infection and injury to both clients and technicians. As infection and disease transmission became better understood, additional measures have been developed to protect technicians and clients. These more hygienic methods have led to the creation of removable, disposable needle bundles that are discarded after each use, preventing cross-infection that was more common with previous single-needle devices.
[0006] Currently, tattooing involves the act of performing an increasingly artistic and relatively safe body art application method, and many products for the procedure are on the market, including mechanical devices for driving needles, hygienic inks and dyes, surgical type, or other infection control methods, to enhance the experience of the technician and the customer alike. It is estimated that tattoos are performed on 20% of the U.S. population. However, many customers wish to alter their body art or remove it completely. This has resulted in the need for tattoo removal and tattoo alteration, which requires the removal of ink contained within the tissue structures of the customer's body.
[0007] Several methods of tattoo removal have been developed over the years, beginning in the 1920s. Such earlier methods dictated that tattoo removal treatment sites must be spaced apart at predetermined intervals to leave tissue bridges that allow each treatment site to be surrounded by active healthy tissue. These bridge areas between treatment sites allow blood-borne healing factors and cells to be delivered to the treatment sites, thereby promoting tissue remodeling in the treatment sites.
[0008] Early treatments were crude and often performed manually using manual needles to create wounds in the client's skin that contained the tattoo ink, which would then be released and eventually removed, either along with the blood in the wound or by coagulating into a necrotic scab that formed as a result of tissue damage caused by the skin abrasion by the needle. If a tissue bridge was not maintained during the removal process, the treatment site would not heal well and excessive scar tissue would form during the healing process.
[0009] Newer methods and options for treatment have improved the application and removal process. However, these devices and methods have their drawbacks. During tattoo application, planning and image placement using patterns and stencils requires time and patience from both the technician and the client. While the time spent during the treatment session is often understood and accepted by both the technician and the client, the time spent planning the tattoo removal process is less accepted. After deciding to remove or change their tattoo, most clients are eager for the process to begin toward completion. However, additional time is needed to ensure the correct approach to the removal of dark pigments and stains and to ensure that the skin bridge is healing properly without causing detectable scarring.
[0010] Removal techniques may require some planning to ensure correct placement of isolated treatment sites, called tegula, to maintain skin bridges and achieve optimal healing. Using templates or stencils as planning tools and marking treatment sites is a major source of time consumed during the tattoo removal process. There is a need for a tool that can assist technicians in spacing treatment sites without extensive upfront planning, thereby reducing overall treatment time, and ensuring proper skin bridges between tegula are maintained.
[0011] After planning is complete, the technician may use a superficial dermabrasion brush to abrade the tissue. The brush may consist of bundled needles similar to those used in tattooing procedures. When using smaller needle bundles, typically about 1-2 mm in diameter, the technician may need to move the needle bundle in a circular motion to completely cover the planned treatment site, often a circular disk 5-6 mm in diameter. While physically moving the needle bundle laterally, the technician oscillates the needle bundle axially in a circular spiral pattern to completely cover each tegula.
[0012] During the removal process, the client's skin may need to be stretched so that the vibrating needle can penetrate the skin more easily and consistently. Needle penetration depth can be controlled by keeping the tip of the needle cartridge opening in contact with the working dermal surface or the outer skin surface. As the needle begins to abrade and disrupt tissue, the working dermal surface becomes deeper due to disruption of tissue structures. Once the treatment area is completely and evenly disrupted, the wound is wiped of loose tissue and exudate, and treatment proceeds to the next tegra.
[0013] The circular motion and speed of the stroke are subjective techniques that vary from technician to technician and often determine the success of the ink removal process. Moving too slowly can result in greater wound damage and increased chances of scarring, while moving too quickly may not destroy enough tissue to achieve complete ink removal. There may also be drawbacks to using larger needle bundles with known devices and methods. In particular, manufacturing constraints and the difficulty of holding the needles in a closely spaced, closely spaced arrangement during assembly may prevent the needles from being so positioned that the coverage required for uniform abrasion may not be achieved. Retention may be an issue due to the difficulty of fixing the needles to each other and to a mechanism that can oscillate the needles at the high speeds required for good penetration and abrasion.
[0014] Therefore, there is a need for a consistent treatment method that incorporates axial vibration along with lateral needle movement that can be administered objectively and treat a single repeatable wound area, thereby making the treatment process faster and more consistent.Specifically, there is a need for a device that has the ability to treat both large and small treatment areas and does not require extensive time spent on stenciling, marking, and treatment planning.Furthermore, there is a need for a device that can treat these areas with consistent treatment diameters, movements, and abrasion instructions, thereby ensuring consistent results in both superficial skin peeling and dermal needling.The devices and methods of use disclosed herein solve these and other problems. Summary of the Invention
[0015] The embodiment system can automate the treatment procedure by programming or controlling one or more of the four independent degrees of freedom: the three mechanical brush movements and the flow of the accelerating fluid. The advantage of this system is that it can make the treatment faster, simpler for the technician and less dependent on the technician's subjective skill. Because the various drive motors and accelerating fluid pumps are independently controlled, the system can be programmed for a variety of applications and treatments, from superficial skin peeling for tattoo removal and scar correction to microneedling for skin tightening and vibration needling for tattooing.
[0016] An embodiment system may include a control component, a drive component, a handpiece component, a cartridge component, and a fluid component.
[0017] The control element may be a fully programmable controller with an electrically driven digital processor or microprocessor for controlling various parts of the system. The control element may be located in a common housing with the drive motor and fluid pump, or may be located remotely and connected either by wire or Bluetooth. The control element may include a touch screen or a graphic display with selection buttons operable with a gloved hand for treatment selection, display and / or stop of treatment parameters (depth, frequency, etc.), and display of treatment results (cumulative treatment time, number of tegras treated, pumping volume used, etc.). In some embodiments, the control element is a wrist controller (connected by Bluetooth and worn by the technician) for customized functionality. All wrist controller functions are also available from the control element and the graphic display.
[0018] The control element may include a foot controller or another sensor used to initiate a selected treatment program. The initiation sensor or switch may be located on the hand piece, or the initiation sensor may be integrated into the wrist controller, which may sense wrist tendon movement, tension, or muscle electrical activity. The controller may be programmed with multiple treatment protocols and type parameters. The controller may accommodate or accommodate new and different software programs that may not have been originally envisioned. The presentation of these different treatment options displayed on the graphic display allows the user to select a needling procedure, tattoo application, tattoo removal, etc., by activating the touch screen. Once selected, the parameters within this device are communicated to the drive system, and once the correct cartridge is installed, the technician can perform the selected treatment. During the treatment, the technician can vary some of the selected parameters, such as the vibration speed, the needle bundle rotation angle, and needle penetration depth, using the wrist controller or also the controller's graphic display. The controller can control multiple functions of the drive and pump at once and blend them into a preprogrammed treatment, or use only one of the drive functions at a time. The rate and speed of needle rotation is controlled and can be a pre-set function or programmed by the technician, once operation is unlocked and access is granted.
[0019] The drive elements can include a vibration drive, a distance (or depth) drive, a rotation drive, and a flexible connecting shaft. First, the vibration drive generates an axial vibration motion. It sets the stroke (total travel from peak to peak) and controls the vibration insertion frequency of the needle. Second, the distance (or depth) drive sets the extension of the vibration motion or the extension distance of the needle from the handpiece, thereby influencing the maximum insertion depth of the needle in the vibration motion. The speed of this drive is variable, so it also drives non-vibrating needles by slower microneedle insertion and withdrawal. Third, the rotation drive rotates the needle bundle during the treatment process and can be controlled to rotate the needle bundle completely or to a predetermined angle or to set the angular position of the needle bundle, as for example when used in tattooing procedures. Fourth, the flexible drive shaft mechanically transmits the three independent motions (vibration, depth, rotation) to the handpiece elements.
[0020] Depending on the embodiment, the independent motions of the flexible mechanical transmission can be combined into one mechanical element, which is one flexible tube or a solid shaft that transmits rotational and axial motion (vibration and distance) simultaneously. In other embodiments, the motion can be split and transmitted between two mechanical elements: an outer torsion tube that transmits rotation and an inner shaft that transmits axial motion (vibration and distance). The flexible mechanical transmission motion can also be split between one mechanical element and one hydraulic element: an outer torsion tube that transmits rotation and an inner hydraulic column that transmits axial motion (vibration and distance).
[0021] The handpiece element is coupleable to the flexible drive shaft and can accept a disposable needle cartridge. The handpiece can smoothly transfer axial and rotational motion (generated by the system and transmitted by the flexible drive shaft) to the cartridge needle bundle generating both axial and rotational motion of the needle bundle.
[0022] At the distal end of the handpiece is an oriented mating receptacle for a needle cartridge that can be locked into place (and later removed) with a quarter turn twist or other disengagement motion. The mating receptacle can be oriented such that when locked into place, the fluid port on the cartridge consistently positions the supply tube in a convenient location, for example, between the thumb and fingers of the operator gripping the handpiece and cartridge. The mating receptacle can be embodied as an oriented oval or other shape.
[0023] The handpiece may include an axial position encoder to programmatically compensate for unpredictable axial motion caused by any reorientation of the handpiece or flexible connecting shaft. The encoder may measure instantaneous needle position, or may measure only the needle position at the peak of vibration extension.
[0024] The axial position encoder can be zeroed each time the cartridge is inserted. Zero is defined as when the maximum extension of the needle tip (during vibration) is just below the plane of the tip of the cartridge tube. An optical or electrical device (e.g., a conductive mesh screen) can be used to perform this zero detection, which is performed with the needle vibrating and is typically performed before the facilitating fluid enters the cartridge.
[0025] Whenever de-energized, the vibration drive can rest in a fully retracted position and be locked into place, preventing needle stick injuries to the operator, allowing repositioning of the cartridge without lifting it from the dermal surface, and preventing axial slippage when microneedling with the depth drive.
[0026] The cartridge elements may include a housing, a multi-sided shaft (polygonal, splined, etc.) keyed to the handpiece drive shaft and connected to a needle platen, a spring, needles, a platen comprising and holding a plurality of sharpened, polished, stainless steel solid needles, and a dermal scraper and support that rotates with the platen but is axially fixed. The housing, shaft, platen, and scraper / support may all be injection molded.
[0027] The cartridge element may be a disposable plastic molded assembly with one or two moving parts at the front (distal) center and containing a needle bundle. The needles may be solid stainless steel medical grade needles that are sharpened and polished, not hollow so that liquids cannot pass through. These needles may be attached to a moving platen or plunger that is axially and rotationally movable along the centerline of the cartridge. The second moving element, which can only rotate, can be used to scrape off abraded debris and to constrain the working skin surface to the tube tip face.
[0028] In the cartridge of the embodiment, the housing is cylindrical with a protrusion on the top side that has a passageway that allows the liquid to travel to the distal end of the cartridge, and on the side, there is a finger grip portion. The platen is held within the housing and is limited in axial movement. There is a spring that helps keep the needle bundle and platen assembly in the proper orientation and / or recess within the cartridge. There is a small hexagonal or other shaped shaft that extends from the rear of the cartridge that, when pushed or rotated, causes the needle bundle to move linearly or axially depending on the force applied. The outer rear (proximal end) of the cartridge has an oval or tilted oval mechanism that allows the cartridge to be inserted into the distal end of the handpiece. The oval tilt mechanism allows the cartridge to rotate into the end of the handpiece and be held by interference of the tilt mechanism and the oval mechanism. The tilt can be molded into another shaped receptacle that fits both the cartridge and the handpiece together and forces the cartridge to maintain its orientation during use. The receptacle allows cartridges of other sizes or capabilities to be similarly inserted and retained and maintain a similar orientation.
[0029] The proximal end of the cartridge housing can lock into an oriented mating receptacle, and its distal end (where the needle extends) can accept a transparent layout disc. The top side of the housing may also include a fluid port that communicates with the needle compartment. The fluid port connects and seals to a supply tube that transports the facilitating fluid solution to the needle compartment. Because operators tend to grip the device as low as possible (even the cartridge itself), finger grip portions may be molded into both sides of the cartridge housing.
[0030] In a further embodiment cartridge, the distal end of the cartridge is shaped to allow the attachment of the part. Without the use of a template or marking the skin in preparation for the treatment, the layout of the Tegra with the proper spacing can be achieved with a layout disk that is attached to the distal end of the needle cartridge (and then removed if desired). This part can be transparent and can have a hat-like portion with a flat circular brim and a central hole to allow the part to be attached to the cartridge housing. When attached, the brim is flush with the distal end of the needle cartridge. A deformable plastic element can be used to allow the hat to be removed while still attached. The transparent hat can be used as a Tegra layout aid, the use of which is described below.
[0031] The hat-shaped layout disk or spacer ring of the embodiment allows the technician to space the treatment sites apart from each other to ensure proper skin bridging and promote the healing process. The use of such components allows the technician to space the treatment sites apart without having to mark the client's skin in preparation for treatment. This can be accomplished by repositioning the handpiece and cartridge so that the collar of the disk does not overlap any part of the skin that has already been treated. This provides the benefit of saving time in the treatment cycle, which can also save the client money and time considering that treatments may be billed by the hour.
[0032] A restrictive orifice or passageway can be molded into the cartridge housing at the end of the fluid path to restrict the flow of the facilitating fluid solution and prevent leakage from the fluid path when unpressurized. The restrictive orifice can allow for tight instantaneous control of the flow of fluid through a programmed positive displacement pump. To conserve fluid and prevent overflow of the tegra (an advantage since the facilitating fluid is often a skin irritant), a volumetrically measured amount of fluid can be sprayed into the needle compartment at the start of each tegra cutting operation.
[0033] The platen and needle bundle can be located at or fixed to the front or distal end of the cartridge. The needle bundle can be configured to suit a particular application or procedure. The needle pattern can be configured as single or multiple lines, crosses, arcs, circles, and combinations of these, or in any other manner that best suits the intended application. The needles in the pattern can be spaced differently to compensate for uneven coverage with rotation. The needles can vary in length and diameter to provide the required flexibility and reach. Graduated or stepped flexibility can be created by graduated or stepped needle diameters. For example, large needle spacing combined with purely axial penetration (without rotation or vibration) allows for minimally traumatic penetration of the skin for use as a cosmetic microneedling treatment to remove wrinkles or tighten the skin. More closely spaced needles that simultaneously oscillate and rotate can be used for tattoo removal and other superficial skin peeling procedures.
[0034] The compact shape and pattern of the needles can be used to perform tattooing. Needle patterns that are not rotationally symmetric (such as single line or magnum double line) can be rotated to a specific azimuth angle to match the inked line or band to be applied. Many types of treatments can be performed using the device of the embodiment. In addition to different sizes and spacing of the needle bundles, the diameter of the needle bundles can be changed from a maximum of 6 mm or more to a minimum of 1 mm or less. Furthermore, the needles can be made longer in length or smaller in diameter to make them more flexible.
[0035] The needle cartridge may include an element that rotates with the platen and needle bundle but does not move axially. The rotating element may be pressed against the working surface of the dermis to scrape away abraded tissue and prevent axial movement of the working surface during the cutting operation of the Tegura. The tissue that contacts the distal surface of the rotating element is on or near the distal surface of the tip of the cartridge tube.
[0036] The cartridge of the embodiment can dispense an accelerator liquid, such as Teprsol®, or even ink, when applying a tattoo or permanent makeup. If a small amount of liquid, such as ink, is required for the treatment, the liquid can be contained in a small reservoir attached directly or adjacent to the cartridge. The other end of the cartridge is connected via a supply tube to a positive displacement pump that drives a working liquid, such as water, which drives the accelerator liquid or ink. If the working liquid and the accelerator liquid are miscible or do not contact for other reasons, the small reservoir can consist of a flexible bag containing the accelerator liquid encased in a rigid container that receives the working liquid.
[0037] Surface tension can keep water-based liquid from flowing out of the tip of the cartridge tube when unpressurized for cartridges with small, compact needle bundles. For embodiments with larger needle bundles where unpressurized liquid may leak out of the tip of the cartridge, control can be achieved by programming the pump to briefly squirt liquid at the start of a programmed Tegra cutting operation. A restrictive orifice or passageway can be molded into the cartridge at the end of the liquid path to keep the liquid in the liquid path and allow for momentary ejection.
[0038] The fluid element is responsible for supplying a programmed flow of the facilitating fluid solution (e.g., Teprsol®) to the needle cartridge and may comprise a fluid container, a fluid pump, and a supply tube. The fluid pump may be a positive displacement pump, and the supply tube may comprise a tube or a tube set, and may connect the fluid container to the needle cartridge. An embodiment may comprise a metered positive displacement pump that can dispense the facilitating fluid to the cartridge element using a supply tube and a luer lock seal or other seal where needed, including on the cartridge. The advantage of such an embodiment is that the fluid volumetric flow rate is controllable independently of the required fluid pressure. If the fluid pump is integrated into the system and controlled by the system, the flow of the fluid may be limited to the Tegra cutting operation, thereby conserving fluid and preventing spills, Tegra overflows, or drips that are typically associated with these procedures.
[0039] The sterile fluid pathway includes all system components that come into contact with the facilitating fluid flowing to the treated skin and can include the three components already mentioned: the fluid container, the delivery tube, and the needle cartridge, all of which are sterilizable, single-use, disposable consumables.
[0040] The connection of the supply tube between the liquid container and the needle cartridge can be accomplished in several ways. For example, the supply tube can be a commercially available tubing set with a luer lock connection on both ends, or it can be initially manufactured and packaged together with the sterile cartridge, or it can be connected to a pigtail that is part of the needle cartridge.
[0041] The fluid pump can be any positive displacement pump that maintains a sterile fluid pathway, such as a syringe pump that drives a fluid-filled syringe or a peristaltic (tube and pinch roller) pump. A positive displacement pump provides a constant (or programmable) volumetric flow rate, independent of the pressure required to drive the fluid.
[0042] Some embodiment systems may include 1) a control element, 2) a drive element, 3) a handpiece element, and 4) a cartridge element. A fifth fluid element may be physically combined with the system or may be physically and functionally separate from the system.
[0043] The system of some embodiments may include a handpiece, a controller, a power supply, and a disposable treatment cartridge. Treatment possibilities are not limited to tattoo removal, but the variable control functions that this device may perform contemplate additional areas of use such as tattoo removal, microneedling, tissue abrasion applications, skin tightening, wrinkle removal, and other cosmetic treatments.
[0044] Turning to functionality, the controller monitors and regulates various functions, memory, data communication, visual display, outcome prediction, and fluid delivery during treatment. The controller may be a self-contained unit or may include a tablet that functions as the controller. The embodiment with a tablet features increased portability around the treatment site and can be used for image capture of the patient's treatment site. The functionality of the system in all embodiments may be established and monitored by the controller. The controller may also include a small handheld or wearable interface configured to communicate with the controller. The controller may further include a graphic display, a user interface, a processor / controller, a power supply, a fluid pump, and a microprocessor.
[0045] The microprocessor controls and coordinates all system functions and can be configured to communicate between the various parts of the device during operation. The microprocessor interfaces with the graphic controller to provide information to the user through the graphic display in both graphic form and voice communication. Selections made in the graphic interface for operation are communicated to the microprocessor for controlling the various parts of the system. The microprocessor controls a library of operations and functions contained within the memory to allow the user to access images, programs, history, or other functions that facilitate operation. If the user desires to use a program in the memory for a treatment option, such items are retrieved by the microprocessor and communicated by the user to the graphic interface for display and interaction. If the user decides to create a program for operation of the device, such an interface can be created within the graphic display, but is evaluated prior to operation to ensure that the program being created is feasible within the hardware parameters and safe for operation, and a warning is issued to the operator if the program has not been tested, approved, or is not clinically viable.
[0046] The microprocessor may be configured to process, store, retrieve, and download images and patient history from other systems where Health Insurance Portability and Accountability Act (HIPPA) compliance protections are in place. The microprocessor can handle communication between the various parts of the device, as well as the pump section, via a direct cable link through the multi-purpose handpiece, or, in embodiments with a wearable controller or remote graphic tablet, via Bluetooth and other wireless communication protocols. The microprocessor can monitor all operation of the parts during set-up and treatment to ensure safe operation and ensure that the various functions under its control are operating with parameters established by the technician, stored requirements, and input feedback from the device's various sensors. Thus, the microprocessor ensures that the operation of the device meets clinical requirements, is performed safely, and protects the patient and user during operation.
[0047] The control system can be contained within the handpiece and communicate during setup and operation. The control and processing within the handpiece can communicate directly with the processor via a hardwire connection using a communication method such as a Controller Area Network (CAN bus) or other equivalent method. In this way, all operations of the handpiece are known and monitored for safe operation, and also provide a buffer against loss of control due to communication interference with systems such as Bluetooth or Wi-fi. In addition to monitoring handpiece functions, the microprocessor can control and monitor the fluid pump functions. This allows for direct control of the pump and coordinated operation of both during treatment.
[0048] Some embodiments of the invention may include a graphical user interface housed in a separate tablet or housed in the main housing itself, configured to provide the user with information regarding selected parameters, operating conditions, and feedback for safely operating the system. The graphical display may be part of the base system or may be housed within the tablet housing. Being in the tablet housing allows the tablet to be moved to the treatment site, located closer to the technician, and used for remote reasons such as image capture, collecting patient input data before treatment begins, or reviewing patient data during treatment preparation. The graphical aspects of the device may include a hard keypad or keyboard for entering data, manipulating files, and viewing or retrieving files.
[0049] The graphics display may include a graphics processor in communication with the microprocessor for displaying information from the microprocessor, such as files, parameters, signals or other information, in both graphical and audio form.
[0050] The graphic display can convert information from the graphic processor into visual information for use by the technician, including graphically displaying the treatment parameters that are set for upcoming treatments, modifying treatment settings, installing and displaying treatment settings, and displaying information for safe operation of the device. Because the technician may be busy or distracted performing a treatment, the graphic display can provide audio and graphic alerts to the technician about the operation of the system and report malfunctions or other deviations in settings from established parameters. Other items that can be displayed include time tracking, suggested treatment options, patient history, preferred / effective treatments, and controls for adjusting treatment parameters to tailor treatment to the patient's skin type. As other treatment options are revealed for use with the device, the graphic interface can show images of what has been assembled, instructions for the procedure, and options for upcoming treatments.
[0051] Some embodiments of the invention may include a power input and a control. The power input of the device may be capable of a voltage input in the range of 100-250 VAC. The power input may have a filter and converter that actively converts the AC voltage to a lower and / or DC voltage usable at the output. The power output of the device may receive lower AC or DC voltages from the input and convert those voltages for use by the system's control, handpiece, and pump. If the control system incorporates a removable tablet or wearable wrist controller, the output may include charging circuitry to ensure that the charge in the batteries of those items is maintained at the appropriate voltage for operation.
[0052] An embodiment of the present invention may include a wearable wrist controller. Alternatively, the controller may have a wrist-worn component that is linked to the controller and can communicate the operating status of the system. The wrist controller may have a graphic screen for displaying images of the status of the system as well as other operating settings and characteristics. The wrist controller may be linked to the main controller by Bluetooth or other communication protocols. The battery of the wrist controller of the embodiment may be recharged when not in use by placing the wrist controller in a predetermined location that includes a charging interface or connection of the main controller or by attaching it to a charging wire or cable. The wrist controller may be washable, sterilizable, and sealed to prevent ingress of liquids. The screen may include virtual buttons that are touch-operated through thin gloves, allowing the user to protect their hands when using the device if they are able to view the execution of the application through the gloves.
[0053] An embodiment of the invention may include an integrated liquid pump for flowing liquid. The device in the controller may include a liquid metering pump that may use the liquid tubing set and openings of the cartridge to dispense Teprsol® or other liquids into the cartridge elements. The advantage of using this type of pump in the system is that the flow of liquid is controllable by the clinician / artist. Additionally, the pump flow may be controlled to stop when treatment is paused or terminated, thereby conserving liquid and preventing spillage or dripping that may be associated with these treatments. The pump flow may be initiated prior to the oscillatory motion of the needle to prevent treatment and needling in the absence of liquid.
[0054] An embodiment of the present invention can include a multi-purpose handpiece. The multi-purpose handpiece / drive system can include three distinct components, each independently controlled and operated by an internal controller: 1) a vibration drive that creates the vibrational motion of the needle bundle, i.e., forward and backward motion, i.e., the in and out motion of the needles as they penetrate the skin; 2) a distance drive that varies the distance traveled by the needle bundle, which translates to the extension of the vibration stroke, i.e., the depth to which the needles penetrate the dermis of the patient; and 3) a rotation drive that translates to the rotation of the needle bundle about a central axis of the needle bundle and handpiece during treatment.
[0055] Each of the drive components may be controlled and monitored via an electrically driven digital controller for proper function and operation. While the drive components often operate in tandem, individual drive components within a handpiece may operate independently for specific treatment parameters. Multi-purpose handpiece systems may be connected to a power source and controller via a cable that provides power and signals to control the handpiece functions.
[0056] The drive components may comprise two stepper-controlled motors and a DC brushless or brushed motor, and include: 1) a rotation drive section comprising a first stepper-controlled motor configured to control the rotational speed and angle of the needle bundle within the cartridge; 2) a distance drive section comprising a second stepper-controlled motor configured to control the distance setting or position of a vibration motor that sets the distance of the needle bundle from the end of the cartridge; and 3) a vibration drive section comprising a DC brushless or brushed motor that controls the vibration of the needle bundle within the cartridge.
[0057] The vibration motor may be a DC motor that can be operated at various rotational speeds by pulse width modulation of the motor control or signal, or simply by varying the voltage of the motor. The rotational speed of this motor can be selected by the clinician during the treatment cycle. The vibration motor drives an eccentric crank that drives a linear shaft, the motion of which eventually strikes the end of the cartridge, thereby moving the cartridge needle bundle within the cartridge in a distal or proximal direction. This vibration speed aids in the disruption of the dermal cells containing the tattoo ink. The system of the embodiment may preferably operate at 4,000 to 14,000 vibrations per minute, more preferably about 10,000 vibrations per minute, although the system may operate above or below the preferred range. If the operator is performing a needling treatment that does not require that vibration frequency, the speed of this motor may be reduced to correspond to the type of treatment being performed.
[0058] The control of this vibration motor can be varied and controlled by manually controlling settings on a control panel or by using a remote controller or wrist-worn controller. Such motors can maintain speed and control by using feedback in the motor housing using Hall effect sensors or other methods, so that the motor speed and armature position can be known and maintained during operation. Knowing the armature position can ensure that the needle is fully retracted and not in an extended position when the operator positions the device during treatment. This motor also allows for very slow speed operation and control, and the armature position can be used to attach and connect the cartridge, and to remove the cartridge after treatment in preparation for disposal.
[0059] Alternatively, the axial drive and connecting shaft assembly can include a hydraulic coupling. In such an embodiment, the vibration motor drives a hydraulically transmitting piston that vibrates a fluid in a flexible connecting tube (which also torsionally transmits the necessary rotation), and the fluid movement is transmitted to a handpiece, which is also configured to contain the fluid and a receiving piston. The hydraulic vibration axially actuates the cartridge needle bundle in the same manner that the vibration motor actuates a flexible rod in the connecting shaft.
[0060] The rotation of the needle bundle mounted in the cartridge can be controlled by a second motor, such as a stepper motor. As the shaft of this stepper motor rotates, the needle bundle located in the cartridge rotates. This motor is connected to the connecting shaft with a belt drive or gear drive appropriate to the design of the system. In the case of splitting the axial and rotational motion transmission, this motor is connected to the outer shank of the connecting shaft. As the motor shaft rotates, the outer shank in the connecting shaft rotates. The rotational motion is transmitted down the connecting shaft to the handpiece and ultimately to the needle bundle located in the cartridge. The speed and rotational angle of this motor may be controlled by a control element, and the specific angle and speed may be part of the programming for the specific treatment parameters programmed into the control element. In another embodiment of motion control and transmission, the axial and rotational motions are combined before the connecting shaft enters the central inner flexible shaft housed in the sheath. This simplification allows for a smaller diameter and more flexible connecting shaft while maintaining the axial and rotational motions generated.
[0061] By controlling both motors simultaneously, a compound motion of the needle bundle can be obtained that can be suitable for many treatment parameters, not just tattoo removal or application. In conventional systems, the clinician may need to move the small needle bundle in a circular motion to cause abrasion of the dermis at the treatment site. The rotational motion of the present system can mimic the circular motion that the clinician performs during a conventional tattoo removal treatment. The advantage of this rotational motion control versus linear motion control is that it allows for greater consistency from treatment site to treatment site, resulting in more consistent healing and dermal exfoliation. Another advantage may be that the clinician may spend less time during the treatment cycle by ensuring that all treatment parameters are met evenly.
[0062] Benefits of compound motions may include different tissue effects as the treatment progresses, and may allow the technician to match treatment parameters based on the firmness or softness of the patient's skin to better suit the treatment procedure. This may also save significant treatment time since the technician does not need to move a small needle bundle in a circular motion as with alternative devices. The flow of the facilitating liquid, such as Teprsol®, can be determined by a positive displacement pump. When driven by the system controller, the pump provides timed flow control for each Tegra cutting operation, with liquid being squirted into the needle chamber only at the beginning of each operation. Alternatively, the pump can be a stand-alone device that produces a constant flow rate throughout the treatment. The same tissue effect and abrasion can be achieved by introducing the liquid at the point of treatment.
[0063] The use of a third motor located within the drive element can vary the distance of the vibration motor either closer to or further from the cartridge tip. The distance element controlled by this motor can vary the distance of the vibration motor from the cartridge tip, thereby varying the penetration depth of the vibrating needle. It may be desirable to have an adjustment range where the depth control can be 0-3mm. For tattoo removal, 1.5mm is preferably used. With other microneedles, such as those used for wrinkle removal and skin tightening, the needle penetration depth may be much less.
[0064] This third stepper motor can drive a carriage that moves the vibration motor toward or away from the distal end of the cartridge tip. Moving the position of this motor also changes the position of the needle bundle within the cartridge, changing the needle penetration depth, either decreasing or increasing. The distance can be read by an external optical encoder or by the stepper motor if it has an encoder. The distance can be changed during operation but is preferably set at the beginning of treatment. The depth control can be located on the controller panel or on a remote panel.
[0065] The motors can be programmed to operate independently as well as collectively. In certain needling treatments, a vibration speed that is too fast would cause too much tissue-needle interaction, so they can be programmed to use only the distance motor. Slow input-output control of the vibration motor can allow for slower and more controlled needle penetration, for example as used in microneedle treatments. To avoid depth deviations, the vibration motor will be fixed (preferably in a fully retracted position).
[0066] In addition to these features, the vibration drive system may include a method for "zeroing" the needle bundle after or before treatment to allow for calibration and accurate measurement of the distance the needles are set to travel from the distal end of the device. This zeroing ensures that what the clinician sets for needle insertion is accurately performed by the device. Such measurement functionality may be included in the drive or handpiece rest of the device, where the cartridge tip may be temporarily inserted into the measurement device for an initial zeroing measurement. Alternatively, such measurement functionality may be included in the control section of the device.
[0067] As previously mentioned, the handpiece control may include a method for retracting the needles when treatment is paused or completed. This allows the needle bundle to be positioned at the patient's skin surface before treatment begins or to resume treatment at another location, allowing slight clinician movement without needle penetration. This may be embodied as a spring drive or mechanical positioning device for the oscillating drive motor so that the cam and drive are correctly positioned in the retracted position during or upon completion of treatment. When de-energized, the oscillating motor should be locked to eliminate depth misalignment. As previously mentioned, information regarding the armature position in the brushless motor may allow the needle bundle to be positioned in the retracted position of the oscillating drive motor, ensuring that the crank and drive are correctly positioned in the retracted position during or upon completion of treatment.
[0068] Some embodiments of the present invention may include a disposable treatment cartridge, which may be a disposable plastic multi-piece assembly that, depending on the assembly configuration, is attached to a handpiece to perform a tattoo removal procedure or other dermatological treatment.
[0069] The disposable treatment cartridge, when attached to a handpiece, can be used to treat, abrade, needle, or puncture human tissue at a specific site or area when the proximal end of the device is placed in contact with the patient's tissue and the handpiece drive is actuated. In tattoo removal, the treatment site that is the result of the abrasion of tissue from the epidermis is called a tegula. The disposable treatment cartridge can include a blade, or a needle, or a combination thereof, that is driven against the epidermis. Materials used in the construction of the disposable treatment cartridge can be composed of medical grade thermoplastics and surgical stainless steel components. The movement and impact of the blade or needle against the epidermis abrade the contacting tissue, creating an abrasion wound or tegula. The size of the treatment area created by the device can correspond to the diameter of the bore in the disposable treatment cartridge and the diameter of the abrasion-generating item.
[0070] The disposable treatment cartridge described herein may comprise an assembly of multiple injection molded parts, a compression spring, and a needle array or blade. The blade is described in more detail herein. The cartridge may comprise an outer housing having a central bore and an angled bore that joins the central bore at an angle near the treatment opening of the cartridge. Through this opening, liquid may be introduced to the treatment site and pumped into the bore from a sterile source through a tubing set. The narrow opening before joining the central bore may be small enough to prevent liquid from dripping and flowing when not being pumped. This liquid application may be used in the tattoo removal process in that it promotes the formation of a clean abrasion wound that scabs nicely, helping the healing process to occur. Even though tattoo removal applications may require liquid application, other dermatological treatments may not require liquid delivery, and therefore liquid ports may not be required in all embodiments of this device.
[0071] The needle arrangement can include a closely packed arrangement, widely spaced needles in a cartridge, rows and columns of needles, or needles of different lengths that result in some needles penetrating more significantly than others during vibration. Such an arrangement of large, spaced needles can be used for aggressive needling treatments to promote collagen development in facial tissues.
[0072] In other embodiments, the wear portion of the tattoo removal cartridge may comprise a thin surgical blade or combination of blades protruding from the needle driving face that can impact the patient's tissue. Such blades may be tapered in one direction, like a razor blade, but have a large width in the other direction. In other versions, the face of the blade may be laser cut or etched to have a needle shape with a sharp sawtooth pattern. Such blades may have different spacing between the sharp tips of the blade. This spacing may form a point similar to a series of side-by-side needles, or may include other needle spacing ratios, such as one needle per needle width, or one needle per two needle widths. The spacing may be mathematically determined to be logarithmic spacing to provide uniform wear when subjected to vibrational or rotational motion. Blades in embodiments may be formed with equal length needle tips. Alternatively, the blades may be cut so that some needles are longer than others, or to form a curved or angled pattern along the axis of the needle tip. Other variations may include making deeper cuts between the needle shapes of the blade to enhance bending and flexing.
[0073] Some embodiments of blade application to the needle holder surface may be groupings of blades in arrangements such as radially spaced blades, even blade rows, or staggered blade rows that when oscillated and rotated simultaneously cause even abrasion with consistent depth and tissue removal. Variations of such blade arrangements have possible arrangements, shapes, and options that can be used to suit other applications for other abrasion or needling applications.
[0074] The structure of the disposable device can include a main housing, a drive rod, a blade holder, and an interface driver. In some embodiments, springs can be used to ensure that the internal parts of the assembly remain in the proper position and return to a rest or safe position upon removal from the handpiece.
[0075] The disposable device may include a single piece housing with a central bore in which the needle, blade, or other item used for abrasion is placed. The exterior of the housing may include features that allow the disposable device to be installed in a mating opening of the hand piece and held in place. Proper orientation and retention features including molded protrusions and holes or other features may help to install the disposable device in a particular orientation in the hand piece and lock that position during use. These features may reduce incorrect installation and subsequent confusion resulting from incorrect use. This exterior molded housing also has an angled protrusion that incorporates an angled tubular bore that mates with the central bore of the housing near the proximal opening of the disposable device.
[0076] In an embodiment system, a drive rod can be located within the central bore. The drive rod connects with a motor driven push rod located within the hand piece. The push rod within the hand piece pushes the drive rod. The design of the push rod within the hand piece also transfers rotational motion to the drive rod within the disposable device during the treatment cycle. The design of the drive rod and its freedom of movement within the molded housing allows the drive rod to rotate while oscillating linearly. The combination of these mechanisms allows for the desired wear at the treatment site. Additionally, because these motions are independently controllable within the hand piece, a variety of treatment options are available based on the configuration of needles or blades attached to the end of the drive rod, as previously described.
[0077] The disposable drive rod and internal opening may preferably be 5mm for tattoo removal, but larger diameter bores and drive rods can be used, allowing for more diverse treatment options depending on the patient's needs. The distal end of the housing may include an integral spring that tensions the cartridge housing during use, maintaining the integrity of the cartridge and aiding ejection upon removal from the handpiece. Also, at the proximal end is an annular disk mechanism that extends outwardly in a direction normal to the axis of the cartridge. The diameter of this disk is calculated to allow the technician to position the cartridge such that each subsequent tegula is spaced from the previous tegula to ensure healing occurs. The cartridge assembly may also include within its design a locking tab mechanism that limits the movement of the drive rod, thereby preventing the technician from accidentally cutting or pricking the needle during installation. Once installed, the locking tab is removed and treatment can be performed.
[0078] Returning to the connecting shaft, the shaft may comprise a flexible conduit with two elements that transmit motion from the drive element to the hand piece and ultimately to the needle bundle located in the cartridge. The ends of the connecting shaft may be provided with threads or other similar types of attachment means, allowing the connecting shaft to be removed and separated from the other parts for maintenance, replacement or upgrade. The shaft of the embodiment comprises an outer sheath that may be polymer coated for maintenance and may include a helical flat wire support within the polymer coating. A further layer may comprise a flexible tube that is a polymer material, or may comprise a helical wire flexible tube that is rotatable within the outer covering. Each end of the tube may comprise a mating mechanism, either male or female, that can mate with a mechanism in the drive element that is attached to the rotary drive motor of the drive and a similar type of mechanism on the proximal mounting end of the hand piece. When driven by the rotary motor of the drive, the rotary motion is converted into a rotary motion of the hand piece.
[0079] In a further embodiment, a flexible metal rod can be placed in the center of the rotating portion of the tubular, hollow connecting shaft. The rod can move linearly within a hollow rotating element in the shaft assembly. One end of the rod is attached to the vibration drive motor, and the other end drives a mating element located in the handpiece. This part in the handpiece can move linearly and freely in rotation. The ability to do both allows connection to the cartridge and allows the needle bundle to be driven linearly and rotationally at the same time, or driven separately as desired. In a further embodiment, the flexible metal rod can be constrained from both axial and rotational motion at the drive end, allowing a mixed motion of both axial and rotational directions to be combined at the drive end, thereby simplifying the design and parts of the connecting shaft.
[0080] In additional embodiments, the handpiece may be located at the distal end of the connection shaft. The proximal end of the handpiece may be provided with a threaded or quick-connect receptacle for connection with the connection shaft. The threaded or quick-connect feature allows the handpiece to be separated from the system for disinfection, cleaning or sterilization. Also, different types of handpieces may be applied if the customer's needs dictate special treatments. The handpiece includes a male-female mating part that connects with the connection shaft assembly that transfers rotational motion from the connection shaft to the proximal end of the cartridge. This part allows the cartridge needle bundle to be driven in rotational or axial motion as determined by the control and drive elements of the system after the areas of motion sequentially performed within the handpiece.
[0081] The handpiece may include an external gripping surface that provides some comfort to the user by absorbing vibrations generated during the treatment process. This surface may be tactile or may be more rigid. A programmed treatment initiation switch may be integrated into the handpiece.
[0082] The distal end of the handpiece may include an oval opening that is on the axis of the handpiece. This oval feature on the handpiece allows a cartridge having a similar oval feature to be rotated and the oval feature will engage and remain securely held. The advantage of the oval feature is that a simple twisting motion locks the cartridge into the handpiece. Removal of the cartridge is the reverse of this twisting motion, which disengages the cartridge from the handpiece. The angle of the oval relative to the plane and axis of the handpiece allows the cartridge to be locked into a similar, predictable position when used by an operator. This positions the cartridge and ensures that the fluid supply is located between the user's thumb and index finger. Because the handpiece does not have features that are located on only one side, the handpiece may be used by a right or left handed user.
[0083] Another version of the handpiece may incorporate a distance determining mechanism that controls the impact distance and range of the linear drive rod on the back of the handpiece, thereby setting the linear travel distance of the drive mechanism within the handpiece. The effect of this setting is to control the penetration depth of the needle bundle as it impacts the client's skin. The handpiece may include markings that indicate an established measurement related to the rotation versus distance of the adjustment mechanism. The distance determining mechanism may include a screw thread. The material of the handpiece may be metal or plastic, depending on the desired manufacturing method and cost of the device.
[0084] The cartridges may be molded plastic assemblies, so they are low cost and may be designated for single use only. The advantages of such an embodiment are that there is less chance of cross-infection from customer to customer and cost savings due to the need to sterilize the device after each treatment. The technician can select these cartridges and can choose the cartridge for the desired treatment. The appropriate cartridge can be displayed on the graphic display of the control element, thereby reducing potential errors of incorrectly selecting the part for each treatment option.
[0085] The described features, structures, advantages, and / or characteristics of the subject matter of the present disclosure may be combined in any suitable manner in one or more embodiments and / or implementations. In the following description, numerous specific details are provided to provide a thorough understanding of the embodiments of the subject matter of the present disclosure. Those skilled in the relevant art will recognize that the subject matter of the present disclosure may be practiced without one or more of the specific features, details, components, materials, and / or methods of a particular embodiment or implementation. In other instances, additional features and advantages may be recognized in a particular embodiment and / or implementation that may not be present in all embodiments or implementations. Furthermore, in some instances, well-known structures, materials, or operations are not shown or described in detail to avoid obscuring aspects of the subject matter of the present disclosure. [Brief description of the drawings]
[0086] In order that the advantages of the present subject matter may be more readily understood, a more particular description of the subject matter briefly described above will be made by reference to specific embodiments which are illustrated in the accompanying drawings, the subject matter being described and explained with additional specificity and detail through the use of these drawings, with the understanding that these drawings depict only typical embodiments of the subject matter and therefore should not be considered as limiting its scope.
[0087] [Figure 1] FIG. 2 is a block diagram of elements of the system of one embodiment. [Diagram 2] FIG. [Diagram 3] FIG. 3 is a perspective view of the handpiece of FIG. 2 with a portion of the cover removed. [Figure 4] FIG. 3 is a perspective view of the handpiece of FIG. 2 with the cover completely removed. [Diagram 5] 3 is a further partial cross-sectional view of the handpiece of FIG. 2. [Figure 6] FIG. 3 is a perspective view of the handpiece of FIG. 2 with the cartridge removed. [Figure 7] FIG. 13 is a perspective view of a vibration carriage lift interface. [Figure 8] 1 is a vibration carriage lift gear control unit. [Figure 9] FIG. [Figure 10] FIG. 13 is a perspective view of the vibration drive, the rotation drive, and the cartridge interface. [Figure 11] FIG. 2 is a perspective view of the fully assembled cartridge elements. [Figure 12] FIG. 2 is a perspective view of a disposable cartridge. [Figure 13] FIG. 2 is a cross-sectional view of a disposable cartridge revealing internal components. [Figure 14] FIG. 13 is an exploded view of the needle holder assembly and drive rod. [Figure 15] FIG. 15 is a perspective view of the needle holder assembly of FIG. [Figure 16A] 1A-1D are end views of a needle holder assembly illustrating various needle configurations of embodiments. [Figure 16B] 1A-1D are end views of a needle holder assembly illustrating various needle configurations of embodiments. [Figure 16C] 1A-1D are end views of a needle holder assembly illustrating various needle configurations of embodiments. [Figure 16D] 1A-1D are end views of a needle holder assembly illustrating various needle configurations of embodiments. [Figure 16E] 1A-1D are end views of a needle holder assembly illustrating various needle configurations of embodiments. [Figure 17A] 1A-1D are elevated side views of various embodiments of needle configurations. [Figure 17B] 1A-1D are elevated side views of various embodiments of needle configurations. [Figure 17C] 1A-1D are elevated side views of various embodiments of needle configurations. [Figure 18A] 1A-1D are elevated side and end views of one embodiment of a needle configuration. [Figure 18B] 1A-1D are elevated side views of various embodiments of needle configurations. [Figure 18C]1A-1D are elevated side views of various embodiments of needle configurations. [Figure 18D] 1A-1D are elevated side views of various embodiments of needle configurations. [Figure 18E] 1A-1D are elevated side views of various embodiments of needle configurations. [Figure 18F] 1A-1D are elevated side views of various embodiments of needle configurations. [Figure 19] FIG. 2 is a perspective view of the drive, connecting shaft, and handpiece. [Figure 20] FIG. 20 is a perspective view of the drive, connecting shaft, and handpiece of FIG. 19. [Figure 21] FIG. 20 is a perspective view of the drive system of FIG. [Figure 22] FIG. 22 is a perspective view of another view of the drive system of FIG. [Figure 23] FIG. [Figure 24] FIG. 2 is a perspective view of a handpiece and a spacing ring. [Diagram 25] FIG. 25 is a perspective view of the handpiece and spacing ring of FIG. 24. [Figure 26] FIG. 25 is a cross-sectional view of the handpiece cartridge and spacing ring of FIG. 24. [Figure 27] FIG. 2 is a perspective view of a disposable cartridge. [Figure 28] FIG. 27 is a cross-sectional view of the disposable cartridge of FIG. 26. [Figure 29] FIG. 27 is a perspective view of a needle bundle coupled to the disposable cartridge of FIG. [Diagram 30] FIG. 1 is a schematic diagram of elements of the system. [Diagram 31] FIG. 2 is a block diagram of a controller. [Diagram 32] FIG. 2 is a perspective view of a vibration motor. [Diagram 33] FIG. 2 is a perspective view of a drive system having a rotary drive motor and a flexible shaft coupled to a handpiece. [Diagram 34] FIG. 34 is a cross-sectional view through the axis of rotation of the drive motor, flexible shaft and handpiece of FIG. 33. [Diagram 35] FIG. 2 is a perspective view of a detached handpiece and disposable cartridge. [Diagram 36] FIG. 2 is a perspective view of a combined handpiece and disposable cartridge. [Figure 37] FIG. 2 is a cross-sectional view of a separated handpiece and disposable cartridge. [Figure 38] FIG. 2 is a cross-sectional view of a combined handpiece and disposable cartridge showing the mechanical relationship of the components. [Figure 39] FIG. 2 is a cross-sectional view of a separated handpiece and disposable cartridge. [Diagram 40] FIG. 2 is a cross-sectional view of the inside of the handpiece showing the mechanical relationships of the various components. [Diagram 41] FIG. 13 is a perspective view of the handpiece with the handle removed, showing the rotation housing and alignment tabs disposed on the disposable cartridge. [Diagram 42] FIG. 1 is a perspective view of a rotating housing of a handpiece coupled to a disposable cartridge. [Diagram 43] FIG. 2 is a transparent perspective view of the internal components of the handpiece including the rotation housing and the rotation drive. [Diagram 44] FIG. 13 is a transparent perspective view of the handpiece showing the rotating shaft advanced toward the proximal end of the handpiece causing displacement of the needle bundle.
[0088] It will be understood that the drawings are illustrative and not limiting of the scope of the invention as defined by the appended claims. The illustrated embodiments achieve various aspects and objects of the invention. It is understood that it is not possible to clearly show each element and aspect of the invention in a single figure, and as such, multiple figures are shown to more clearly and separately show various details of the invention. Similarly, not all embodiments need achieve all advantages of the invention.
[0089] While the present disclosure is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the disclosure is not intended to be limited to the particular forms disclosed. Rather, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
[0090] Throughout the description, similar reference numbers may be used to identify similar elements. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0091] It will be readily understood that the components of the embodiments, as generally described herein and illustrated in the accompanying figures, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure, but is merely representative of various embodiments. While various aspects of the embodiments are illustrated in the drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
[0092] Throughout this specification, references to features, advantages, or similar terms do not imply that all of the features and advantages that may be realized in the present invention should or are present in any single embodiment of the present invention. Rather, language referring to features and advantages is understood to mean that the particular feature, advantage, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, throughout this specification, discussions of features and advantages, as well as similar terms, may, but do not necessarily, refer to the same embodiment.
[0093] Unless otherwise indicated, terms such as "first," "second," etc. are used herein merely as labels and are not intended to impose any ordering, positional, or hierarchical requirements on the items to which they refer. Moreover, a reference to, for example, a second item does not require or preclude the presence of, for example, a "first" or lower-numbered item, and / or, for example, a "third" or higher-numbered item.
[0094] Furthermore, in this specification, examples of an element being "coupled to another element" may include direct coupling and indirect coupling. Direct coupling may be defined as a state in which an element is coupled to another element and is in some contact with the other element. Indirect coupling may be defined as coupling between two elements that are not in direct contact with each other, but have one or more additional elements between the coupled elements. Furthermore, as used herein, fixing an element to another element may include direct coupling and indirect coupling. Furthermore, as used herein, "adjacent" does not necessarily mean in contact. For example, an element may be adjacent to another element without being in contact with the other element.
[0095] In the above description, certain terms may be used, such as "top", "bottom", "upper", "lower", "upper", "down", "upper", "lower", "horizontal", "vertical", "left", "right", "above", "below". These terms are used to provide some clarity to the description when dealing with relative relationships, where applicable. However, these terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" surface may become a "lower" surface simply by flipping the object over. It is still the same object. Furthermore, the terms "include", "comprise", "have", and variations thereof mean "including, but not limited to", unless expressly specified otherwise. The enumeration of items does not imply that any or all of the items are mutually exclusive and / or mutually inclusive, unless expressly specified otherwise. Additionally, the terms "a", "an", and "the" refer to "one or more", unless expressly specified otherwise. Additionally, the term "plurality" may be defined as "at least two".
[0096] Unless otherwise indicated, terms such as "first," "second," etc. are used herein merely as labels and are not intended to impose any ordering, positional, or hierarchical requirements on the items to which they refer. Moreover, a reference to, for example, a second item does not require or preclude the presence of, for example, a "first" or lower-numbered item, and / or, for example, a "third" or higher-numbered item.
[0097] The schematic flow chart diagrams and schematic method diagrams described above are generally set forth as logical flow chart diagrams. As such, the depicted order and labeled steps are indicative of exemplary embodiments. Other steps, orders, and methods are contemplated that are equivalent in function, logic, or effect to one or more steps, or portions thereof, of the methods illustrated in the schematic diagrams.
[0098] Furthermore, the described features, advantages, and characteristics of the invention may be combined in any suitable manner in one or more embodiments. Those skilled in the relevant art will recognize in light of the description herein that the invention may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments of the invention.
[0099] Throughout this specification, reference to "one embodiment," "an embodiment," or similar terms means that a particular feature, structure, or characteristic described in connection with the illustrated embodiment is included in at least one embodiment of the invention. Thus, throughout this specification, the terms "in one embodiment," "in an embodiment," and similar terms may, but do not necessarily, all refer to the same embodiment.
[0100] Many embodiments are described herein, at least some of which allow for efficient removal of tattoos, permanent makeup, and other permanent marks or pigments on and under the skin, whether intentionally applied (such as tattoos) or naturally acquired (such as pigmented lesions and skin scars). Although the description herein primarily refers to tattoo removal, the devices, systems, and methods described herein can also be utilized for other treatments on tattoos or on a customer's skin. Two broad classes of treatments that can be achieved by the embodiments described herein include superficial skin peeling (for scar correction and removal of tattoos, permanent makeup, pigmented lesions, etc.), and axial needling or cosmetic microneedling (for tattoos, skin tightening, wrinkle removal, etc.).
[0101] Throughout this disclosure, reference is made to enhancement fluid and / or Teprsol® (a registered trademark of Rejuvatek Medical Inc.). It should be understood that these terms are used synonymously to refer to any suitable enhancement fluid as understood by those skilled in the art, whether that fluid is Teprsol® or another liquid. The enhancement fluid may be any liquid solution formulated to assist the system in performing various superficial skin peeling and / or axial needling procedures, the formulation of which may be varied and adapted to the particular procedure.
[0102] Throughout this disclosure, references to dermal penetration forces and shear forces may be generated by either blades, needles, brushes, or similar instruments that may engage in three mechanical motions: high speed oscillating axial motion, low speed positional axial motion, and low speed rotational lateral motion. Note that "high speed" and "low speed" are relative terms. The term "axial" means substantially along the axis of the treatment needle, and the term "lateral" means perpendicular or orthogonal to the axis of the treatment needle. The system can automate treatment procedures by programming four independent degrees of freedom: the three mechanical brush motions and the flow of the facilitating fluid.
[0103] In accordance with an embodiment system, FIG. 1 shows a flow chart illustrating the elements of a system for use in tattoo application and removal and other skin treatments, including a cartridge assembly 1, a hand piece 2, a system controller 3, a foot controller 4, and a wearable wrist controller 5. Each of these elements may vary in design, arrangement of parts, materials, and construction without substantially departing from the functionality described herein. The system controller 3 includes a power input / output 6, and the system obtains power from an external power source, such as a wall outlet. The system controller 3 monitors and sets the voltage values for operation of a drive system 15, which may be housed within a housing or located externally, as shown in FIG. 2. The system controller 3 includes a microprocessor 7 with a microprocessor control, memory storage, operation control, and monitoring mechanism. The microprocessor 7 issues instructions to other components within the system controller 3.
[0104] The system controller 3 may include an input / output ("I / O") section or module 8. The I / O section 8 provides an interface with external components of the system, such as connection to the handpiece 2, touch control, power control, and other inputs from and outputs to the user. The I / O section 8 also allows for wireless communication 9 via a remote control unit of the wearable wrist controller 5. Additionally, the I / O section 8 handles data communication feedback 10 indicating correct operation, measurement, and control of vibration velocity from the handpiece 2, measurement and control of the rotation motors, and feedback position and attitude of the position motors. Each component may provide feedback that is input to the microprocessor 7.
[0105] The microprocessor 7 interfaces with and controls various components of the system according to computer code, programming, and instructions stored and executed within the microprocessor. The microprocessor 7 interfaces with a graphics processing unit 11 which converts the instructions and programs into graphic images that can be interpreted by a user for operation of the device. The graphics processing unit 11 communicates with a graphics display at a graphics processor interface 12 to receive and present the instruction set to the user in the form of an image. In response, the user can then react to the image form and provide input to the microprocessor 7 via the graphics processing unit 11 using the graphics processor interface 12.
[0106] The system controller 3 may further comprise a communication interface. If an external device is connected and controlled, the graphic processor interface 12 provides an interface between various elements including the foot controller 4 or wearable wrist controller 5 and the fluid pump 13. Other items as enumerated in the following description may include automatic control of the handpiece by optical or switch control operated by the clinician. Communication between the components may be provided by various wireless control methods such as Bluetooth or Wi-Fi. The handpiece control 14 may control the vibration, rotation and depth of the needle bundle 49 as shown in FIG. 15. The manipulation and control of the needle bundle 49 controls the interaction with the patient's skin surface where the treatment is performed.
[0107] As shown in FIGS. 2-6, the handpiece 2 of the embodiment may include a housing 78. The housing may include a first housing portion 78a and a second housing portion 78b that are connected to each other and provide protection and containment for the internal components. The housing portions 78a, 78b may be removable as needed for maintenance and reassembled as needed to perform their functions. The outer surface of the housing 78 may be formed with a mechanism such as a gripping element or a vent hole 84. The handpiece 2 may be coupled to a controller via a flexible cable wired to a connector 16 of the handpiece 2. The connector is connected to an internal handpiece controller 14 that communicates with the I / O section 8 of the microprocessor 7 and provides control to each system within the handpiece 2. Sensor control and operation control may be wired through the controller 14 of the handpiece 2 that is connected to each subsystem.
[0108] The handpiece 2 of the embodiment may include a handle portion 19. Attached to the handle 19 may be an auxiliary grip 18 which may be attached to or adjacent to an underside 79 of the handle. The auxiliary grip 18 may be attached by a dovetail fitting mechanism 80 or other suitable connection. The auxiliary grip 18 is held as a stabilizer by the operator's thumb and index finger when gripping the handle 19 in one or more recesses 56 which may be located near the end of the handle portion 19 adjacent the disposable cartridge 37. The auxiliary grip 18 may extend into the operator's hand and be half-gripped by the remaining fingers of the hand.
[0109] The handpiece 2 of the embodiment can include a vertical frame 17 that holds or connects the various components of the drive system 15 in position and alignment. Fasteners 81 can extend through the first housing portion 78a to the second housing portion 78b. The fasteners 81 can extend through or connect with openings 82 in the vertical frame 17 disposed in an interior cavity formed at least in part by the first housing portion 78a and the second housing portion 78b. In the exemplary embodiment, at the distal or upper end of the frame 17 is a block 21 that holds a lift mechanism 83 of the drive system 15 in position.
[0110] The lift mechanism 83 of the embodiment is shown more fully in Figs. 7-8. Attached to the block 21 is a gear train 24 which rotates a lead screw shaft 25. The gear train 24 drives another gear attached to a first stepping motor 23. The first stepping motor 23 provides rotational motion to the gear train 24 which interfaces with the lead screw shaft 25. The rotational motion of the first stepping motor 23 rotates the lead screw shaft 25 which is connected to the vibration drive frame 50, thereby positioning the drive on the vertical frame 17 to a position set by the system controller 3. The carriage is fitted with linear bearings 51 to allow smooth positioning as required. The position in terms of travel distance or height is measured by a slotted signal ring 52 and read by a sensor on the printed circuit board 26. The travel limits of the vibration drive frame 50 are measured by a Hall effect device 31 which may be attached to the vibration drive frame 50. At each end of travel there is a magnet coupled to the vertical frame 17 which sets the limits or set positions of the travel by communicating with a Hall effect device 31. Power for the first stepper motor 23 is delivered from the handpiece controller 14 which receives the motor voltage through a flexible cable connected at the connecting shaft assembly 16.
[0111] Returning to Figures 3-6, the drive system 15 of the embodiment may also include a vibration drive 85. The drive 85 may include a vibration motor 22 that is speed controlled with a signal from the microprocessor 7 that is first transmitted to the handpiece controller 14 and then to a brushless motor commutator. As further shown in Figures 9-10, the end of the shaft 86 of the vibration motor 22 includes an eccentric crank 28 that is rotated by the vibration motor 22. Coupled to the eccentric crank 28 is a wire rod 29 that extends from the eccentric crank 28 through the rotation block 34 and connects with the drive rod 30 in the drive rod 38 of the cartridge. When the wire rod 29 is held in the opening 87 of the rotation block 34, the rotational motion is slowed to a linear motion that is used to drive the needle bundle 49 in a linear motion to impinge on the patient's tissue when the needle bundle 49 is positioned against the tissue at the treatment site.
[0112] The vibration motor 22 is mounted on a vibration drive frame 50 which rides on the vertical frame 17 and is movable in a linear motion by sliding on linear bearings 51. The vibration drive frame 50 can be moved and positioned anywhere within a predetermined range controlled by a Hall effect device 31 and magnets attached to the vertical frame 17. This vertical motion allows the needle bundle to be positioned so that the tips are flush with the cartridge end or protrude a specific amount determined by the treatment parameters. (See Figures 10-11.) A counterweight 88 on the eccentric crank 28 reduces vibrations from the vibration motor drive making operation more comfortable for the technician.
[0113] FIG. 10 illustrates the relationship between an embodiment of a vibration drive 85 and an embodiment of a cartridge 37. Also shown in this figure is an embodiment of an additional drive 89 that rotates a drive rod 30 that transmits the rotational motion to a drive rod 38 of the cartridge. This drive of the embodiment provides the rotational motion to the needle bundle as described in the description of operation. This rotational motion can replace the hand movements of the technician during the attrition process. The rotational motion is initiated by driving a second stepper motor 32 that transmits its motion to a gear combination 36. The gear combination is fixed to a rotating block 34 that is suspended on a radial bearing 53. As the second stepper motor 32 rotates, the rotating block 34 also rotates at a 1:1 ratio. The center of the rotating block 34 has a hexagonal opening within its center. The drive rod 30 is fitted into the block and has a similar hexagonal shape to the block. As the rotating block 34 rotates, the drive rod 30 rotates. The amount and speed of rotation is measured by a sensor positioned to view the signal wheel 33. When a rotation signal is sent from the microprocessor, the handpiece controller 14 receives the signal and provides direction and speed information to the second stepper motor 32 for rotating the rotation block 34. The cartridge drive rod 38 includes an interface slot 35 that transfers motion received from the drive rod 30 to the cartridge drive rod 38.
[0114] 9 also illustrates male interface features 90 that are used in the embodiment drive system 15 to transfer motion from the drive rod 30 to the cartridge drive rod 38. These interface features 90 may include tabs extending from the exterior surface of the drive rod 30 to engage corresponding slots 91 formed in the cartridge drive rod 38. Because the oscillatory and rotational motions are controlled separately and integrated into the rotation block and drive rod assembly, both motions can be controlled independently and integrated into a combined linear and rotational motion that is transferred to the needle bundle 49.
[0115] 10-14 show an embodiment of a disposable cartridge 37. The disposable cartridge 37 may comprise multiple molded parts that are assembled together and sterilized prior to use. The housing 92 of the disposable cartridge 37 may be made from a durable, sterilizable molded plastic material. The molded parts may be constructed from polycarbonate, ABS / polycarbonate blends, or similar polymers. The housing may comprise a protruding side 41 that comprises a locking mechanism 93. The locking mechanism may comprise a tab or extension 94 adapted to engage with internal threads formed on the inner surface of the mating luer lock. The locking mechanism allows the tubing set carrying the fluid to pass through the joint with little chance of leakage. Within the locking mechanism is a small hole 44 that allows fluid introduced at the locking mechanism to be transmitted to the end of the cartridge at the end of the needle bundle where abrasion or treatment can take place. A smaller integral opening 55 is added to the passageway of the cartridge to restrict the flow of Teprsol® fluid during operation. This prevents the liquid from flowing freely over and around the treatment area, eliminating the risk of wasting liquid or releasing too much liquid during treatment.
[0116] In a further embodiment, the housing also has a raised feature 40 thereon that ensures that the disposable cartridge 39 can only be mounted in one way and is secure during operation. A recess in the raised feature interfaces with a retention button 20 located on the handle 19 that securely holds the cartridge during treatment. (See FIG. 3.) Once locked in place, the vibrations that occur during use are not enough to cause these parts to separate during treatment. At the distal end of the cartridge is a molded spring 39 that presses against the disposable cartridge mounting surface 95 of the handpiece, the spring pressure preventing the disposable cartridge 37 from vibrating during use. This spring force also allows the disposable cartridge 37 to be removed after treatment, which has the advantage of reducing the chance of the technician accidentally touching the needle / blade.
[0117] The disposable cartridge 37 may also include a cylindrical feature 96 at the distal end that is the attachment location for the spacer ring 42. The tolerances of the cylindrical feature and the spacer ring 42 allow the two to fit together and remain attached throughout the treatment cycle. The treatment ring 42 may help the technician space the tegulas from each other leaving a skin bridge remaining between the tegulas to promote proper healing. The protruding surface 41 at the top of the disposable cartridge 37 is the location of the flexible tubing connection 54. The flexible tubing connection 54 is a connection for attaching a tubing set, which allows the pump and fluid delivery to be located several feet away from the treatment site. Within the proximal end of the disposable cartridge 37, the needle bundle 49 is shown nested within a cylindrical flange that surrounds the needle bundle 49, protecting it from damage.
[0118] The smaller integral opening 55 on the passage of the disposable cartridge 37 restricts the flow of Teprsol® liquid during operation. This prevents the fluid from flowing freely over and around the treatment site, eliminating the possibility of wasting fluid or discharging too much fluid during treatment. The disposable cartridge 37 further includes a spring 45 that assists in the retraction of the needle bundle 49 during the treatment process. This retraction can ensure that the needle bundle 49 can rotate freely during treatment. Rotation of the needle bundle 49 may occur prior to full retraction of the needle bundle 49, if desired. Alternatively, the disposable cartridge 37 may not include a spring, or the spring 45 may only serve to ensure that the internal parts of the assembly are maintained in the proper position. In such an embodiment, the drive mechanism including the drive rod 38 may directly drive the extension and retraction of the needle bundle rod 46, such that the reciprocating motion is not dependent on the action or return force of the spring 45.
[0119] A seal 47 prevents excess Teprsol® liquid from flowing out the back of the disposable cartridge 37. Any excess liquid that enters this section can flow out of the chamber through an opening 56. At the proximal end of the disposable cartridge 37, a needle interface rod 38 provides an interface with parts of the hand piece 2 for linear and rotational motion. The parts of the hand piece 2 move in a linear motion that directly translates the cartridge drive rod 38, which in turn translates the needle bundle rod 46. When applied to the skin of the recipient, the needle bundle 49 extends from the distal end of the disposable cartridge 37 and pierces the skin of the recipient as it acts in a linear motion via the cartridge drive rod 38 and the needle bundle rod 46.
[0120] 13-14 show an embodiment of a needle bundle 49. The needle bundle 49 can be of larger or smaller diameter size with densely or sparsely spaced high or low density needles depending on the type of procedure being performed. It is contemplated that the needle bundle may be designed in other patterns other than circular, for example, triangular or square mounts with various needle patterns with various densities of needles. The embodiment of FIGS. 13-14 shows an offset linear pattern. Other patterns will be understood by those skilled in the art. The needle holder or needle bundle rod 46 supports the needle bundle 49 and provides an interface to the drive components of the needle bundle 49 as well as strength to push the needles into the skin of the patient. The needle bundle rod 46 may be molded of a plastic material and the needles may be inserted by machine and molded into place or inserted by hand and molded into place. For a sparse needle configuration, the needle bundle rod 46 may include holes for manually placing the needles and securing them with adhesive.
[0121] The needle bundle rod 46 of the embodiment connects with the cartridge drive rod 38 within the cartridge housing and is secured by a snap fit. At the rear of the needle bundle rod 46 is a hexagonal feature 58 that ensures that the two parts can rotate as one part when assembled. The needle bundle rod 46 includes a hexagonal interface feature 58 that connects with a mating feature 57 on the cartridge drive rod 38. The hexagonal interface feature 58 mates with each other to ensure that the rotational motion is translated into the needle bundle.
[0122] The cartridge housing of the embodiment further includes a locking tab 43 that locks the linear movement of the needle rod 46 and cartridge drive 38. When inserted into the cartridge housing 43, the tab is inserted into an annular recess 48 in the cartridge drive rod 38. This prevents the needle / blade from extending during loading of the cartridge into the handpiece. The tab is removed after loading of the disposable cartridge 37 and can be discarded when the disposable cartridge 37 is removed and ready to be discarded or retained for reloading.
[0123] As shown in FIGS. 14-15, the needle holder can include a generally cylindrical shaft 97 that extends from a needle face 98 at the distal end of the holder to a hexagonal interface 58 at the proximal end. A locking tab 99 or another locking mechanism can extend from the proximal end of the interface 58. The locking tab 99 can engage with an end of a mating socket 57 of the cartridge drive rod 38 or an adjacent corresponding mechanism. A protrusion 171 can extend from a sidewall of the shaft 97 to engage an inner surface 172 of the disposable cartridge. The protrusion 171 can include a first proximal portion 173 and a second distal portion 174. The distal portion can extend away from the surface of the shaft 97 and can have an end surface 175 that is flush with the needle face 98. While the shaft 97 is illustrated as cylindrical, it can instead have a triangular, rectangular, oval, or other cross-sectional shape.
[0124] As shown in Figures 15 and 16A-16E, one or more needle bundles 49 may extend from the needle face 98. The needle bundles 49, blades, or individual needles may be attached to the needle face. For example, the needle bundles may be inserted into recesses 176 formed in the needle face. The needle bundles may be attached by inserting the needle bundles into the recesses and securing them by adhesive, press fit, or other mechanisms. Alternatively, the needle holder 46 may be injection molded around the needle bundles such that the needle bundles are secured to the holder. The recesses 176 may be elongated 176a, circular 176b, or some other shape depending on the shape of the needle bundle, blade, or needle being inserted.
[0125] Needle holder 49 embodiments are shown in Figures 16A-16E including various combinations and arrangements of needles or blades. For example, the needle pack can be arranged as single needles 59, double needles 60, triple needles 61, or quadruple needles 62. If a single needle is desired for certain applications, the single needles can be grouped or spaced in a grid or pattern-like configuration 74 with a grid of multiple needles extending outward from a central region. Alternatively, the needle holder can include a series of recesses 176b arranged in a pattern 74 on the needle face 98 into which a user can place one or more needles in a custom arrangement suited to the user's needs or preferences. It will be appreciated that the possible arrangements can vary depending on the application of the cartridge and the location where the needle holder is loaded.
[0126] 17A-17C show elevational views of embodiment needle / blade configurations. A compact linear configuration 63 can arrange a group of needles in a tight single layer arrangement. Such groups can be placed in recesses 176 of needle face 98 in various arrangements depending on the molded part. Alternatively, a spaced linear configuration 64 can arrange needles spaced apart from one another without touching or overlapping needles. A staggered configuration 65 can arrange a group of needles in two or more rows, with the needles of a first row spatially offset from the needles of a second row. The needles of the second row can be offset from the needles of subsequent rows in a similar manner.
[0127] 18A-18F show elevational views of needle assemblies having various configurations of embodiments. The needle assembly 66 can include a fixed end 233 and a piercing end 234. The fixed end 233 can include one or a notch 240 that helps secure the needle assembly to the needle holder 46. The piercing end 234 can include one or more individual needles or multiple blades or points 68. The tips of the multiple blades 68 can be cut with laser energy or manufactured from a chemical etching process or similar technique. A recess or cavity 177 can extend into or through the blade 67. The cavity can reduce the mass of the blade 67 or increase the strength, rigidity, or stability of the blade 67. The needle assembly 66 can be constructed from flat surgical material that is bevel cut or etched in one direction to cut a needle or sawtooth shape and ground in the other direction to achieve a sharp, needle-like shape.
[0128] The blades 68 may feature a uniformly spaced configuration 69 in a row. The blades 68 may be manufactured by means similar to the processing of razor blades, with a taper at the tip being ground to achieve a sharp edge with a deep root at the spacing of the blade tips. This allows the blades 68 to penetrate deeper without the root of the blades 68 hitting the surface of the tissue they impinge upon. The variable spacing configuration 70 may be created using mathematical spacing calculations, such as logarithmic or geometric spacing algorithms. Such spacing may aid in attrition as the blades vibrate linearly while rotating on their axis. The angled configuration 71 may position the blades at various heights along a linear axis. Similarly, the curved angled configuration 72 may position the blades at various heights along a curved axis. Because the design of the blades 68 is not limited to mechanical hand assemblies, the design of the blades 68 has many options available to accommodate other applications in addition to mere tattoo removal. For example, the deep recess configuration 73 may include a recess along the longitudinal axis between the shafts of the blades 68 that resembles a needle. The deep recess configuration 73 helps the needle or multiple blades 68 to be more flexible. Additionally, the spacing may help retain liquids such as ink or pain management analgesics. The deep recess configuration 73 may also be used for artistic tattooing or long-lasting makeup art. FIGS. 18A-18F show an embodiment blade 67 having a generally flat, straight configuration formed from a single piece. However, the blade may be bent or shaped into other configurations such as a "C", "N", "O", "W", or other shapes. Alternatively, the blade may be formed from multiple pieces into a multi-legged shape such as a "Y" or "+" shape.
[0129] As shown in FIG. 30, the system of the embodiment includes a cartridge assembly 101, a hand piece 117, a drive connection 103, a drive unit 104, a system controller 105, a foot controller 106, and a remote controller 107. As shown in FIGS. 19-29, the cartridge assembly 101 can include a disposable cartridge 143 with a needle bundle 152. The drive connection 103 can include a connecting shaft assembly 116, and the drive unit 104 can include a drive system 115. As shown in FIG. 31, the system controller 105 of the embodiment can include a power supply 109 that obtains power from an external power source such as a wall outlet. The power supply 109 controls and sets voltage values for the operation of the drive system, which may be contained within the housing or external. The processor 110 of the controller can include a microprocessor control, memory storage, operation control, and monitoring mechanisms, and can provide instructions to other components in the control system. One output of the processor 110 can provide an I / O control 114.
[0130] The I / O control 114 may provide an interface with external components of the system, such as connection to drives, touch control, power control, and other inputs from the user and outputs that the user can manipulate. One function of the I / O control 114 may be to enable user control by a remote controller 107, which may be a wrist controller. Another function of the I / O control 114 may be to provide feedback from the drives 104 indicative of correct operation as well as measurement and control of vibration velocity, measurement and control of rotation motors, and feedback position and attitude of position motors. Each of these components has feedback provided to the processor 110, which maintains control based on programs and instructions stored and executed therein.
[0131] The processor 110 interfaces with a graphics controller 111 that may function to convert instructions and programs into user-interpretable graphic images for operation of the device. The graphics controller 111 communicates with a graphics display 112 that receives a set of instructions and displays them in an image format. A user can respond and react to the graphic format and provide input to the processor 110 through the interface components of the graphics display 112 and the graphics controller 111.
[0132] The system controller 108 may also include a communications interface 113. Communications within the system controller 108 are internal and linked by software or hardware control. If an external device is attached and controlled, the communications interface 113 may provide that interface. Interfaces with various elements may include switches on the foot controller 106, or other elements on the remote wrist controller 107. Other components or functions may include automatic control of the handpiece 117 by technician operated optical or switch control. Various wireless control methods may be used, such as Bluetooth or Wi-Fi, so that the control system does not need to be fixed to components such as the wrist controller 107 or foot controller 106.
[0133] In some embodiments, as shown in Figures 19-20, the device can include a drive system 115, a connecting shaft assembly 116, and a hand piece 117. The drive system 115 can control the vibration, rotation, and depth of the needle bundle. The connecting shaft assembly 116 transmits the drive motion from the drive system 115 to a hand piece 117 assembly, to which a cartridge housing is attached that houses the needle bundle. As shown in Figure 20, the drive system 115, the connecting shaft assembly 116, and the hand piece 117 can be separated for configuration as well as for use and maintenance. These items can be separated as needed and reassembled as needed to perform their functions. This separation allows for substitution of different assemblies as needed for repairs or functional upgrades.
[0134] 21-22, the drive assembly 115 can include various subsystems including an oscillating drive, a rotary drive, and a distance or depth drive. In the embodiment system, a frame 132 holds the various components in a predetermined position and arrangement. The embodiment system can include a rotary drive with a holding block 178 at the distal end of the frame 132 that holds the driven pulley 130 in a predetermined position. A belt 121 can couple the driven pulley 130 and the driving pulley 131. A stepper motor 120 rotates the driving pulley 131, which in turn rotates the driven pulley 130 by the belt 121. A drive interface block 123 can be connected to the driven pulley 130 such that the interface block rotates with the rotation of the pulley. The interface block 123 can be engaged with the connecting shaft assembly 116. The rotary motion is transferred by the connecting shaft and ultimately to the needle bundle. Stepper motor 120 receives its commands from processor 110 via a hard-connect cable or wireless communication. Power for this motor, like all motors in the drive subsystem, is provided by power supply 109.
[0135] The drive system of the embodiment may also include a vibration drive. The vibration drive may include a vibration motor 124, which may be a brushed or brushless DC motor that is speed controlled by the processor 110. At the end of the shaft 180 of the vibration motor 124 is an eccentric crank 118 that is rotated by the vibration motor 124. Attached to the crank is a wire rod 122 that extends from the crank, passes through an opening in the pulley 130, and connects with a flexible rod 140 in a flexible connecting shaft 134 (see FIG. 23). When the flexible rod 140 is held in the opening, the rotational motion is slowed to a linear motion that is used to drive the needle bundle 152 in a linear motion to impact the client's tissue when the needle bundle 152 is positioned against the tissue at the treatment site (see FIG. 26).
[0136] An embodiment system can include a depth drive in which a vibe motor 124 is mounted on a carriage 129 that can move in a linear motion by riding on two control rods 126, 127. The carriage can move and be positioned along the length of the pair of control rods. The drive for this positioning is provided by a depth stepper motor 119 that has a threaded rod 128 attached to it. The carriage 129 has an opening 181 with female threads therein that connect with the threaded rod 128.
[0137] Thus, as the depth stepper motor 119 is repositioned, the carriage 129 moves towards or away from the motor 119. The position of the carriage 129 is monitored by an optical encoder 125 and sensor. An encoder grid allows the position of the carriage 129 to be monitored. If desired, the motor 119 can incorporate an internal encoder to monitor the position of the carriage. As with all other drive components of the drive subsystem, power is derived from a power supply 109 located within the system controller 108 and is monitored and controlled by the processor 110. A graphical representation of the drive status can be displayed on the graphic display 112 to indicate to the user the correct and desired operation of the components.
[0138] For example, as shown in FIG. 23 and FIG. 30, the connecting shaft assembly 116 can comprise a flexible shaft that allows for positioning of the components within the treatment area of the clinic while providing the technician with freedom of movement and mobility when placing the handpiece 117 and cartridge 143 on the client's body. As shown in FIG. 23, the connecting shaft of the embodiment comprises a flexible outer sheath 133 that stores items inside and keeps it clean from dirt and debris. The proximal end 138 of the flexible connecting shaft 134 connects with the drive subassembly 115 and the distal end connects with the subassembly of the handpiece 117. Within the shaft is a flexible tube 139 and a flexible rod 140. At each end of the flexible tube 139 is an interface receiving mechanism 136 that connects with the interface block 123 of the drive assembly 115 and the rotational interface mechanism 146 of the handpiece 102. The interface mechanisms 123, 136 transfer the rotational motion from the drive assembly 115 to the handpiece 117. The end of the flexible connecting shaft 134 may include a threaded or quick disconnect mechanism 135 that secures the ends of the shaft at the drive end and the hand piece end. Contained within the center of a flexible tube 139 within the flexible outer sheath 133 is a flexible rod 140. The flexible rod 140 is driven by the linear motion of the drive subassembly which ultimately transfers the linear motion to the needle bundle 152. The end 137 of the flexible rod 140 connects with a mechanism within the hand piece 117 which transfers the linear motion to the cartridge assembly 101 and the needle bundle 152.
[0139] An embodiment handpiece 117 and cartridge 143 is shown in Figure 24. The handpiece 117 can include a grip or housing 141 with a collar 142 that acts as an adjuster on the end of the cartridge 143 and a spacer ring 144. The handpiece subassembly can include an interface piece 146 that interfaces with a flexible connecting shaft for the transfer of linear and rotational motion to the cartridge 143 and needle bundle 152.
[0140] As shown in Figures 25-26, a rotational interface mechanism 146 at the proximal end of the handpiece 117 can accept rotational motion from the flexible connection shaft. The rotational interface mechanism 146 can rotate freely within the housing 141 of the handpiece 117. Bearings 147 can allow for linear sliding motion while maintaining an interlock to control the rotational motion. Here, a mixture of rotational and linear motion may occur within the handpiece 117.
[0141] In further embodiments, control of the linear stroke distance can be performed by the hand piece 117 instead of the drive assembly 115. Thus, the collar 142 can include a threaded mechanism 148 that interfaces with the housing 141 of the hand piece 117. The threaded mechanism can include a stop in its rotational adjustment to prevent the collar from dislodging from the hand piece housing. The collar 142 can include indicia that indicate a coarse adjustment of the needle impact depth at the treatment site. In embodiments of the system, either one or both of the adjustment mechanisms can be used. Alternatively, the collar 142 can be a slider collar with a detent that indicates the needle impact depth. The hand piece interface 145 can include a female interface mechanism 189 that engages with a male mechanism 190 of the cartridge 143 and transmits motion to the needle bundle 152 within the cartridge 143.
[0142] As shown in FIGS. 24-26, the cartridge 143 may include a spacer ring 144 that is generally "hat shaped" and has an opening 191 that allows the spacer ring 144 to be placed at the end of the cartridge 143 and remain during vibrations that occur during the treatment process. The spacer ring 144 may further include a disk 192 that may be placed at or near the treatment site. The spacer ring 144 may be made from a clear plastic material, and treatment may be performed with or without the spacer ring 144 in place. The spacer ring 144 may provide a visual spacing guide and help the technician space the tegras from one another so that a skin bridge remains between the tegras to promote proper healing.
[0143] As shown in Figures 27-28, the cartridge 143 may comprise a plastic molded assembly of multiple parts. In accordance with an embodiment system, the proximal end 193 of the cartridge housing 149 is cylindrical and engages the handpiece 117 with a press fit or other fit to maintain a proper interface and prevent unnecessary friction of the motion drive. This cylindrical portion 193 of the cartridge housing 149 may comprise two angled oval mechanisms 150 extending from the cylinder body. These mechanisms allow the cartridge housing 149 to be rotated and locked into place on the proximal end of the handpiece 117, which is also oval. Once locked into place, vibrations generated during use are not sufficient to separate the parts during treatment.
[0144] The cartridge 143 can also have a cylindrical feature 151 at the distal end where the spacer ring 144 is attached. The tolerances of this feature and the ring allow the two to fit together and remain in place throughout the treatment cycle. At the top of the cartridge 143 is a flexible tubing set 153, which can be short with a luer lock feature attached as shown, or long with the luer lock feature spaced away from the cartridge, preferably several feet away. In a further embodiment, the cartridge 143 can have a luer lock feature molded into the cartridge to which the tubing is attached, thereby eliminating the need for a tubing assembly.
[0145] Within the distal end of the cartridge 144, the needle bundle 152 is housed within a cylindrical flange 194 that surrounds the needle bundle 152 and protects it from damage. Within the cartridge housing 149, a fluid passageway 155 connects with a flexible tubing set 153. Through the flexible tubing set 153 and the fluid passageway 155, Teprsol or other facilitating liquid can be administered to the treatment site during tattoo removal. An integral opening can be added to the fluid passageway 155 to restrict the flow of Teprsol liquid during operation. This can prevent free flow of liquid into and around the treatment site, which can result in wasted liquid or over-discharge of liquid during treatment. The cartridge housing 149 can also include a spring 154 that ensures the needle bundle 152 is retracted during the treatment process. Retraction can ensure that the needle bundle 152 can rotate freely during treatment. Rotation of the needle bundle 152 can occur before the needle bundle 152 is fully retracted. Alternatively, cartridge 144 may not include a spring, or spring 154 may function only to ensure that the internal components of the assembly are maintained in the proper position. In such an embodiment, the drive mechanism including needle interface rod 156 may directly drive the extension and retraction of needle bundle 152 such that the reciprocating motion is not dependent on the action or return force of spring 154.
[0146] The seal 159 can reduce or prevent excess Teprsol liquid from exiting the back of the cartridge. Any excess liquid that enters this section can exit the chamber 195 through the hole 160. At the proximal end of the cartridge 143, the needle interface rod 156 provides an interface with the handpiece components for rotational as well as linear motion. When the handpiece components move in a linear motion, that motion directly translates the interface rod 156, which translates to the needle bundle rod 157. When applied to the skin of a customer, the needle bundle 152 extends from the distal end of the cartridge to pierce the skin of the customer as it acts in a linear motion through the interface rod 156 and the needle bundle rod 157.
[0147] As shown in FIG. 29, the needle bundle 152 can be attached to the front surface 198 of the needle bundle rod 157. The needle bundle can be a larger or smaller diameter size with a high density of closely spaced needles or a low density of spaced needles. The needle face 198 can be designed in other patterns other than circular, such as a triangular mount or a square mount with various needle patterns thereon with various densities of needles. The embodiment of FIG. 29 shows the needle bundle 152 in a cross pattern. Other patterns will be understood by those skilled in the art.
[0148] The needle rod 157 supports the needle bundle 152 and provides the strength to drive the needles into the client's skin as well as an interface between the needle bundle and the drive components. The rod can be molded of a plastic material and the needles can be inserted by machine and molded into place or inserted by hand and molded into place. For sparse needle configurations as described above, the needle face 198 can be configured with a pattern of holes and the needles can be placed by hand and secured with adhesive. The needle rod 157 interfaces with the interface rod 156. The two parts are assembled within the cartridge housing and secured by a snap fit. At the rear of the needle rod is a male hex feature 196 that engages with a corresponding female hex feature 197 formed on the interface rod 156 so that when assembled, the two parts rotate as one part. The interface rod 156 can include an interface feature 158 that engages with the handpiece interface 145. The hex feature ensures that the rotational motion is transferred. It will be appreciated that other feature shapes may be used, including squares, triangles, rectangles, ovals, or other suitable shapes.
[0149] As shown in FIG. 32, an embodiment of a vibration motor 161 can include a shaft 162 that rotates when a voltage is applied to the motor from a drive 235 of a controller 170. The drive 235 of the controller 170 can apply a high voltage or a long duty cycle to the motor to cause the motor to achieve the speed required by the treatment parameters contained within the controller memory. The shaft 162 is connected to a crank 166 with a bearing 167 allowing a wire drive 168 to maintain its aligned position relative to the crank 166 to drive a flexible rod 169. The shaft can include a slot 164 or a disk 163 having multiple slots. The position of the slot 164 or mechanism is sensed by a sensor 165, which can be an optical device, a magnetic device, or a physical interface such as a cam follower. The output of the sensor 165 is sent to the controller 170. With this information, the controller can adjust the rotational movement of the needles in sync with the vibration. This information can also be used to retract the needle bundle upon completion of treatment or during a break in treatment to reposition the cartridge to another treatment site. Rotation of the needle bundle can be performed in a predetermined manner based on treatment parameters or can be used to control the rotational force as a way to enhance treatment. Thus, the additional wear can reduce treatment time and provide the same tissue effect in tattoo removal as when an operator manually moves the needles during treatment.
[0150] As shown in FIGS. 33-34, in some embodiments, the drive system 201 can include a flexible shaft 208, a hand piece 209 that can be coupled to a disposable cartridge 210, and a drive motor 203 that can be rotated in unison with the central axis of the flexible shaft 208 and coupled to a central drive wire 207 located at the center of the flexible shaft 208 via a coupling 205. The drive motor 203 can further be coupled to a moveable carriage 202 on the distal side of the drive assembly 201, which allows the drive motor 203 to move toward or away from the flexible shaft 208 along a linear axis 204 as shown. The linear axis 204 allows the drive wire 207 to change position relative to the distal end of the flexible shaft 208. Coupling a rotational coupling 205 of the drive motor 203 to the drive wire 207 rotates the drive wire. The flexible sheath or inner housing 219 surrounding the drive wire 207 is rotated by a stepper motor 238 and gear combination 206 located on a face 239 of the drive system 201. The gear combination then transfers the rotational motion to the flexible shaft using a gear coupling 211.
[0151] The flexible shaft 208 of the embodiment includes an outer sheath 236, an inner sheath 219, and a drive wire 207. The inner sheath 219 can include a rotational coupling 212 at a proximal end located within the hand piece 209 that is driven by a gear coupling 211. The gear coupling 211 transmits rotational motion from a first end of the flexible shaft 208 to a second end of the flexible shaft 208 to the inner sheath. The drive wire 207 is coupled to a drive motor 203 by a coupling 205. Thus coupled, the drive wire 207 can be rotated at any speed by the drive motor 203 that transmits its rotational motion to the rotational coupling 212 located within the hand piece 209. The drive wire 207 and the inner sheath 219 can be rotated independently. The rotation of the inner sheath 219 within the flexible shaft 208 can be driven independently by a gear combination 206. Thus, all three movements are transmitted to the flexible shaft 208 and to other internal components located within the handpiece 209 .
[0152] 35-37, the disposable cartridge 210 can include a follower 215 and a locking ridge 214 located on the distal end of the disposable cartridge 210. The handpiece 209 can also include a recess 216 at its proximal end that receives the locking ridge 214 on the distal end of the disposable cartridge 210. Once inserted into the recess 216, the disposable cartridge 210 can be rotated slightly to secure and lock the handpiece 209 and disposable cartridge 210 as a unit.
[0153] The flexible shaft 208 can be coupled to a needle bundle 218 that is detachable from the hand piece 209. At the distal end of the hand piece 209, an inner sheath 219 can terminate in a rotation coupling 212. The drive wire 207 can likewise terminate and be secured within a coupler 220. The drive wire can be inserted into a recess 221 in the proximal end of the coupler 220. When the drive wire 207 is rotated by the drive motor 203, this motion is transferred to the coupler 220. It will be appreciated that the design of the drive system 201 allows for the hand piece 209 or the flexible shaft 208 to be serviced and assembled independently of one another, while once assembled, the rotational motion can be converted to linear motion.
[0154] Within the handpiece 209, the coupler 220 can be coupled to a swashplate 224. The swashplate 224 can be made from a hardened material that can withstand wear and tear from use, such as hardened ground steel or a similar metal or alloy. The swashplate 224 can also include a slide receptacle 229 that mates with the coupler 220 and transfers the rotational motion from the drive wire 207 to the rear of the swashplate 224. The rotational coupling 212 can be coupled to a bearing retainer 227 and a rotational housing 223. The rotational motion from the flexible shaft 208 is transferred from the coupler 220 to the swashplate 224, where the rotational motion is transferred from the rotational coupling 212, which is coupled to the rotational housing 223, through the bearing retainer 227.
[0155] To ensure that rotational motion from the drive wire 207 is transferred with minimal friction, the swash plate 224 rotates in a first radial bearing 225 and a second radial bearing 226. It will be appreciated that this rotation ensures accurate and free motion for actuating the drive system 201. The first bearing 225 and the second bearing 226 may be preloaded to ensure proper rotational freedom by a second compression spring 222. The first bearing 225 and the second bearing 226 are held by a bearing retainer 227, which may be a separate part to allow for installation of the first bearing 225 and the second bearing 226 during initial assembly of the drive system 201. After assembly, the bearing retainer 227 may be coupled to the rotating housing 223 to ensure that the rotating components are securely fixed and free to move for motion transfer.
[0156] The follower 215 may be rigidly coupled to the needle bundle 218. The hand piece 209 may include a compression spring 217 that urges the follower 215 away from the disposable cartridge 210 and keeps the needle bundle 218 fully retracted within the disposable cartridge 210. The compression spring 217 may be positioned as shown to maintain the follower 215 in a fixed initial position until the follower 215 is urged toward the disposable cartridge 210 and the compression spring 217 is compressed. When released, the follower 215 naturally returns to its initial rest position, fully retracting the needle bundle 218 into the disposable cartridge 210. Alternatively, the hand piece may not include a spring, or the spring 217 may function only to ensure that the internal components of the assembly are maintained in the proper position. In such an embodiment, the drive mechanism including the drive wire 207 may directly drive the extension and retraction of the needle bundle 218 such that the reciprocating motion is not dependent on the action or return force of the spring 217.
[0157] As shown in Figures 38-40, the disposable cartridge 210 of the embodiment can be coupled to the handpiece 209. When coupled, the follower 215 impacts the swashplate 224. As the swashplate 224 rotates, the follower 215 is pushed from its initial position at rest, thereby compressing the compression spring 217, and the needle bundle 218 also moves forward and is exposed from within the housing of the disposable cartridge 210. Then, as the swashplate fully rotates, the follower 215 engages with the surface features of the swashplate 224, and the follower 215 moves from one end of the profile of the swashplate 224 to the other end. This rotational motion of the swashplate 224 converts the motion of the follower 215 into linear motion, causing the needle interface rod 237 and the needle bundle 218 to extend and retract. The conversion of linear motion causes the needle bundle 218 to impact the patient's skin surface, providing linear needle motion during the abrasion process. Thus, rotational motion from drive wire 207 is converted to linear motion at needle bundle 218 .
[0158] A coupling mechanism 231 of the bearing retainer 227 mates with a coupler 220 that is driven by an inner sheath 219 within the flexible shaft 208. The bearing retainer 227 and the rotating housing 223 are coupled together so that when the inner sheath 219 is driven in rotation by the gear combination 206 of the drive system 201, the rotational motion is transmitted to the coupler 220, which in turn rotates the bearing retainer 227 and the rotating housing assembly 223. The rotating housing 223 is free to rotate within the handpiece housing 209 and is retained by a retainer ring 228 to prevent disengagement from the housing 209.
[0159] 41, the coupler 220 can rotate the bearing retainer 227 and the rotating housing 223. The rotating housing 223 can have a slot 232. As the rotating housing 223 rotates within the handpiece 209, the slot 232 and anything within the slot 232 rotates. The follower 215 can have a tab 230 that is similar in size and width to fit within the slot 232 of the rotating housing 223.
[0160] As shown in FIGS. 42-43, the follower 215 may be aligned for assembly with the disposable cartridge 210 such that the tabs 230 of the follower 215 are inserted into the slots 232 of the rotating housing 223. In an embodiment system, the rotating coupler 223 rotates independently of the handpiece housing 209, and the follower 215 disposed within the disposable cartridge 210 and coupled to the needle bundle 218 is also driven to rotate by the tabs 230 and slots 232 of the rotating housing 223. Thus, it will be appreciated that in some embodiments, linear motion of the needle bundle 218 may be accomplished by the rotation of the swash plate 224 which in turn drives the follower 224. Rotational motion of the follower 215 may be accomplished simultaneously by rotation of the rotating housing 223, independent of the handpiece housing 209.
[0161] In tattoo removal, it is desirable to vary the depth at which the needle can operate during the abrasion process. Tattoo ink depth varies from patient to patient, and there is no set distance for ink depth as all skin physiology is uniformly different from patient to patient. Thus, the embodiment device allows the needle to vary its penetration to accommodate patients of all physiologies. The depth can be varied and controlled to ensure that the depth is known and repeatable or can be trusted to be accurate. The carriage 202 is movable and precisely positioned to position the drive motor 203 relative to the hand piece 209. The drive wire 207 is rigid and free to move within the flexible shaft 208, so any position of the drive motor 203 within the drive assembly 201 translates to the end of the drive wire 207 being moved or positioned as desired within the hand piece 209. To vary the position of the needle bundle 218 within the disposable cartridge 210, a method of moving the needles by moving the impact features of the swash plate 224 and follower 215 is used. In this case, the wire drive coupler is moved by repositioning the drive wires.
[0162] As shown in FIG. 44, the system of the embodiment includes a rotating shaft that can be advanced toward the proximal end of the disposable cartridge 210 moving the needle bundle 218. The repositioning process pushes the distal end of the swash plate 224 away from the bearing, repositioning the face of the swash plate 224, thereby forcing the follower into the disposable cartridge 210, thereby repositioning the needle bundle 218. Due to the location of the drive motor 203, with these items repositioned within the drive assembly 201, the depth of the needle bundle 218 can be controlled during its stroke and rotation. The compression spring 217 located at the distal end of the rotating housing 223 and bearing assembly 227 also acts to retract the swash plate 224 as it returns to its initial position at rest. It will be appreciated that the drive assembly 201 allows for linear movement of the needles for abrasion, rotational position or rotational movement of the needles to enhance abrasion, and depth control and position of the needles relative to the surface of the patient's skin in the movement of the disposable cartridge 210 and thus the tattoo removal process. In some embodiments, the swashplate 224 may be incorporated in a condensed version, allowing the drive motor 203 to be housed within the handpiece and perform the functions described above.
Claims
1. 1. A system for use in tattoo application and removal and other skin treatments, comprising: A handpiece and a disposable cartridge coupleable to the handpiece, the disposable cartridge including a needle bundle and a flexible tubing connection coupleable to a fluid pump configured to deliver an accelerating fluid to the needle bundle; a system controller including a power input, a microprocessor, and a graphics processing unit, the system controller configured to control the operation of one or more drives; a vibration drive configured to impart a vibration motion to the needle bundle, the vibration drive comprising a vibration drive frame, a vibration motor, and an eccentric crank; a depth drive including a block, a first motor, a gear train, a lead screw shaft, and a sensor, the first distance drive configured to impart linear motion to the needle bundle; a rotary drive including a motor, a drive rod, and a gear combination configured to impart rotational motion to the needle bundle; a drive shaft configured to independently impart vibrational, linear, and rotational motion to the needle bundle; A system comprising:
2. The system of claim 1 , further comprising a wearable wrist controller configured to adjust treatment parameters of the handpiece.
3. The system of claim 1 , further comprising a foot controller configured to start and stop operation of the system when engaged and disengaged.
4. The system of claim 1 further comprising a tablet controller.
5. The system of claim 1 , wherein the system controller is configured to control the start, flow rate, and stop of the enhancing liquid being pumped by the liquid pump.
6. 1. A system for use in tattoo application and removal and other skin treatments, comprising: A handpiece and a needle bundle having a plurality of blades; a disposable cartridge coupleable to the handpiece, the disposable cartridge having a connection coupleable to a fluid pump configured to deliver an accelerating fluid to the needle bundle; a system controller having a power input, a microprocessor, and a user interface, the system controller configured to control the operation of one or more drives; a vibration drive configured to impart a vibration motion to the needle bundle, the vibration drive comprising a vibration drive frame, a vibration motor, and an eccentric crank; a depth drive including a block, a motor, a gear train, a lead screw shaft, and a sensor, the depth drive configured such that a first distance drive imparts linear motion to the needle bundle; a rotary drive including a second motor, a drive rod, a signal wheel, and a gear combination, the rotary drive configured to impart rotational motion to the needle bundle; a drive shaft configured to independently impart vibrational, linear, and rotational motion to the needle bundle; A system comprising:
7. The system of claim 6 , wherein the plurality of blades comprises an angled configuration, the plurality of blades being positioned at different heights along a linear axis.
8. The system of claim 6 , wherein the plurality of blades are configured to wear evenly when rotated and oscillated simultaneously.
9. The system of claim 6 , wherein the drive shaft is flexible.
10. The system of claim 6 , further comprising a wearable wrist controller configured to adjust treatment parameters of the handpiece.
11. The system of claim 6 , further comprising a foot controller configured to start and stop operation of the system when engaged and disengaged.
12. The system of claim 6 further comprising a tablet controller.
13. The system of claim 6 , wherein the system controller is configured to control the start, flow rate, and stop of the enhancing liquid being pumped by the liquid pump.
14. The system of claim 6 , wherein the microprocessor is configured to operate the vibration drive, the distance drive, and the rotation drive individually and cooperatively.
15. 1. A system for use in tattoo application and removal and other skin treatments, comprising: A handpiece and A needle bundle and a disposable cartridge coupleable to the handpiece, the disposable cartridge including a flexible tubing connection coupleable to a fluid pump configured to deliver an accelerating fluid to the needle bundle; a system controller including a power input, a microprocessor, and a graphics processing unit, the system controller configured to control the operation of one or more drives; a vibration drive configured to impart a vibration motion to the needle bundle, the vibration drive comprising a vibration drive frame, a vibration motor, and an eccentric crank; a distance drive including a block, a first stepper motor, a gear train, a lead screw shaft, a printed circuit board, and a Hall effect device, wherein the first distance drive is configured to impart linear motion to the needle bundle; a rotary drive unit including a rotation block, a second stepper motor, a drive rod, a signal wheel, and a gear combination, the rotary drive unit configured to impart rotational motion to the needle bundle; a drive shaft configured to independently impart vibrational, linear, and rotational motion to the needle bundle; A system comprising:
16. 16. The system of claim 15, wherein the needle bundle comprises a compact linear configuration, the needle bundle configured to arrange a group of needles in a single layer arrangement.
17. 16. The system of claim 15, wherein the needle bundle comprises a spaced linear configuration, the needle bundle configured to arrange a group of needles spaced apart from one another without touching or overlapping needles.
18. 16. The system of claim 15, wherein the needle bundle comprises a staggered configuration, the needle bundle configured to arrange a group of needles in two or more rows with needles in a first row spatially offset from needles in a second row.
19. The system of claim 15 , wherein the system controller is configured to control the start, flow rate, and stop of the enhancing liquid being pumped by the liquid pump.
20. 16. The system of claim 15, wherein the microprocessor is configured to operate the vibration drive, the distance drive, and the rotation drive individually and cooperatively.
21. 1. A system for use in tattoo application and removal and other skin treatments, comprising: A handpiece and a disposable cartridge coupleable to the handpiece, the disposable cartridge including a needle bundle and a flexible tubing connection coupleable to a fluid pump configured to deliver an accelerating fluid to the needle bundle; a system controller including a power input, a microprocessor, and a graphics processing unit, the system controller configured to monitor and adjust voltage values for operation of one or more drives; a vibration drive configured to impart a vibration motion to the needle bundle, the vibration drive comprising a vibration drive frame, a vibration motor, and an eccentric crank; a distance drive including a block, a first stepper motor, a gear train, a lead screw shaft, a printed circuit board, and a Hall effect device, wherein the first distance drive is configured to impart linear motion to the needle bundle; a rotary drive including a second stepper motor, a belt drive, a pulley, and an interface mechanism, the rotary drive configured to impart rotary motion to the needle bundle; a flexible drive shaft configured to independently impart vibrational, linear, and rotational motion to the needle bundle; A system comprising:
22. 22. The system of claim 21, further comprising a wearable wrist controller configured to adjust treatment parameters of the handpiece.
23. 22. The system of claim 21, further comprising a foot controller configured to start and stop operation of the system when engaged and disengaged.
24. 22. The system of claim 21, further comprising a tablet controller.
25. 22. The system of claim 21, wherein the system controller is configured to control the start, flow rate, and stop of the enhancing liquid being pumped by the liquid pump.
26. 22. The system of claim 21, further comprising a substantially hat-shaped spacer ring coupled to the disposable cartridge configured to space treatment sites at predetermined intervals without prior marking of a patient's skin.
27. 22. The system of claim 21, wherein the needle bundle retracts into the disposable cartridge housing when the oscillating drive is paused or stopped.
28. 1. A system for use in tattoo application and removal and other skin treatments, comprising: a handpiece comprising a swashplate, a rotating housing, a rotary coupling, a compression spring, and one or more radial bearings, the swashplate configured to convert rotational motion into linear motion; a disposable cartridge coupleable to the handpiece, the disposable cartridge including a needle bundle and a flexible tubing connection coupleable to a fluid pump configured to deliver an accelerating fluid to the needle bundle; a system controller including a power input, a microprocessor, and a graphics processing unit, the system controller configured to monitor and adjust voltage values for operation of one or more drives; a vibration drive configured to impart a vibration motion to the needle bundle, the vibration drive comprising a vibration drive frame, a vibration motor, and an eccentric crank; a distance drive including a block, a first stepper motor, a gear train, a lead screw shaft, a printed circuit board, and a Hall effect device, wherein the first distance drive is configured to impart linear motion to the needle bundle; a rotary drive unit including a rotation block, a second stepper motor, a drive rod, a signal wheel, and a gear combination, the rotary drive unit configured to impart rotational motion to the needle bundle; a flexible drive shaft configured to independently impart vibrational, linear, and rotational motion to the needle bundle; A system comprising:
29. 30. The system of claim 28, further comprising a wearable wrist controller configured to adjust treatment parameters of the handpiece.
30. 30. The system of claim 28, further comprising a foot controller configured to start and stop operation of the system when engaged and disengaged.
31. 30. The system of claim 28, further comprising a tablet controller.
32. 30. The system of claim 28, wherein the system controller is configured to control the start, flow rate, and stop of the enhancing liquid being pumped by the liquid pump.
33. 30. The system of claim 28, wherein the microprocessor is configured to operate the vibration drive, the distance drive, and the rotation drive individually and cooperatively.
34. 30. The system of claim 28, further comprising a substantially hat-shaped spacer ring coupled to the disposable cartridge configured to space treatment sites at predetermined intervals without prior marking of a patient's skin.
35. 30. The system of claim 28, wherein the needle bundle retracts into the disposable cartridge housing when the oscillating drive is paused or stopped.