SYSTEM FOR USE IN THE APPLICATION AND REMOVAL OF TATTOOS AND OTHER SKIN TREATMENTS

Abstract

An automated system featuring a system controller, an oscillation drive, a linear drive, a rotational drive, a flexible drive shaft, a handpiece, and a disposable cartridge used for the application or removal of tattoos and for use in skin treatment such as needling, skin tightening, aesthetic microneedling, and superficial dermabrasion procedures. A needle cartridge or plurality of blades may be couplable in modular configurations within the disposable cartridge. The automated system may also have a plurality of blades or needle bundles in various configurations couplable to the disposable cartridge selected in accordance to the skin treatment performed. The system may also include a physically integrated and functionally automated fluid pump with associated disposable fluid container and disposable feed tube. Alternately, the fluid pump may stand physically and functionally independent of the automated system.

Claims

1. A system for use in the application and removal of tattoos and other skin treatments, comprising: a handpiece; a set of disposable cartridges comprising a first disposable cartridge comprising a first needle bundle and a second disposable cartridge comprising a second needle bundle, each disposable cartridge of the set being alternatively couplable to the handpiece, each disposable cartridge further comprising a tubing connection couplable to a fluid pump configured to dispense facilitating fluid to the needle bundle; a system controller comprising a power input, a microprocessor, and a user interface, the system controller configured to control the operation of one or more drives; an oscillation drive configured to provide oscillatory motion to the needle bundle; a distance drive configured to provide linear motion to the needle bundle; a rotational drive configured to provide rotational motion to the needle bundle; and a drive shaft configured to independently translate oscillatory, linear, and rotational motion to the needle bundle; wherein the needle bundle of the first disposable cartridge comprises a first configuration; and wherein the needle bundle of the second disposable cartridge comprises a second configuration.

2. The system of claim 1, wherein the first needle bundle comprises a flat blade, the flat blade comprising a securement end and a penetration end.

3. The system of claim 2, wherein the penetration end of flat blade of the first needle bundle comprises a plurality of points.

4. The system of claim 3, wherein the plurality of points forms a sawtooth shape.

5. The system of claim 3, wherein the plurality of points is cut at an angle in a first direction.

6. The system of claim 5, wherein the plurality of points is sharpened in a second direction.

7. The system of claim 5, wherein the plurality of points is sharpened in the second direction by grinding.

8. The system of claim 3, wherein the plurality of points has a first depth.

9. The system of claim 8, wherein the second needle bundle comprises a second flat blade, the second flat blade comprising a securement end and a penetration end comprising a plurality of points having a second depth that is greater than the first depth.

10. The system of claim 2, wherein the second needle bundle comprises a second blade, wherein the second blade is not flat.

11. The system of claim 3, wherein the plurality of points has a first uniform spacing between each point.

12. The system of claim 11, wherein the second needle bundle comprises a second blade, the second blade comprising a securement end and a penetration end comprising a plurality of points having a second, uniform spacing between each point, the second uniform spacing being greater than the first uniform spacing.

13. The system of claim 11, wherein the second needle bundle comprises a second blade, the second blade comprising a securement end and a penetration end comprising a plurality of points having a second nonuniform spacing between each point.

14. The system of claim 3, wherein the plurality of points has a first uniform length.

15. The system of claim 14, wherein the second needle bundle comprises a second blade, the second blade comprising a securement end and a penetration end comprising a plurality of points having a second nonuniform length.

16. A system for use in the application and removal of tattoos and other skin treatments, comprising: a handpiece; a first disposable cartridge comprising a first needle bundle having a first configuration, the first disposable cartridge selectively couplable to the handpiece; a second disposable cartridge comprising a second needle bundle having a second configuration that is distinct from the first configuration, the second disposable cartridge selectively couplable to the handpiece; a system controller comprising a power input, a microprocessor, and a user interface, the system controller configured to control the operation of one or more drives; an oscillation drive configured to provide oscillatory motion to the needle bundle; a distance drive configured to provide linear motion to the needle bundle; a rotational drive configured to provide rotational motion to the needle bundle; and a drive shaft configured to independently translate oscillatory, linear, and rotational motion to the needle bundle.

17. The system of claim 16, wherein the first disposable cartridge comprises a tubing connection couplable to a fluid pump configured to dispense facilitating fluid to the needle bundle.

18. The system of claim 16, wherein the first disposable cartridge comprises needle bundle rod comprising a needle face and the second disposable cartridge comprises needle bundle rod comprising a needle face.

19. The system of claim 18, wherein the first disposable cartridge comprises a flat blade, the flat blade comprising a securement end and a penetration end, and wherein the flat blade securement end is connected with the needle bundle rod at the needle face.

20. The system of claim 18, wherein the second disposable cartridge comprises a plurality of needles, each needle comprising a securement end and a penetration end, and wherein each needle securement end is connected with the needle bundle rod at the needle face.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0086] In order that the advantages of the subject matter may be more readily understood, a more particular description of the subject matter briefly described above will be rendered by reference to specific embodiments that are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the subject matter and are not therefore to be considered to be limiting of its scope, the subject matter will be described and explained with additional specificity and detail through the use of the drawings.

[0087] FIG. 1 is a block diagram of elements of an embodiment of the system;

[0088] FIG. 2 is a perspective view of a handpiece;

[0089] FIG. 3 is a perspective view of the handpiece of FIG. 2 with a portion of the cover removed;

[0090] FIG. 4 is a perspective view of the handpiece of FIG. 2 with the cover fully removed;

[0091] FIG. 5 further partially cut-away view of the handpiece of FIG. 2;

[0092] FIG. 6 is a perspective view of the handpiece of FIG. 2 with the cartridge removed;

[0093] FIG. 7 is a perspective view of an oscillation carriage lift interface;

[0094] FIG. 8 is an oscillation carriage lift gear control;

[0095] FIG. 9 is a perspective view of an oscillation drive;

[0096] FIG. 10 is a perspective view of an oscillation drive, a rotation drive, and a cartridge interface;

[0097] FIG. 11 is a perspective view of a cartridge element fully assembled;

[0098] FIG. 12 is a perspective view of a disposable cartridge;

[0099] FIG. 13 is a cutaway of disposable cartridge revealing internal components;

[0100] FIG. 14 is an exploded view of a needle holder assembly, and a drive rod;

[0101] FIG. 15 is a perspective view of the needle holder assembly of FIG. 14;

[0102] FIGS. 16A-E are end views of the needle holder assembly showing embodiments of various needle configurations;

[0103] FIGS. 17A-C are elevation side views of various embodiments of needle configurations;

[0104] FIG. 18A is elevation side and edge views of an embodiment of a needle configuration;

[0105] FIGS. 18B-F are elevation side views of various embodiments of needle configurations;

[0106] FIG. 19 is a perspective view of a drive, a connection shaft, and a handpiece;

[0107] FIG. 20 is a perspective view of the drive, the connection shaft, and the handpiece of FIG. 19;

[0108] FIG. 21 is a perspective view of the drive system of FIG. 19;

[0109] FIG. 22 is a perspective view of an alternative view of the drive system of FIG. 21;

[0110] FIG. 23 is a perspective view of a connection shaft;

[0111] FIG. 24 is a perspective view of a handpiece and a spacing ring;

[0112] FIG. 25 is a perspective view of the handpiece and spacing ring of FIG. 24;

[0113] FIG. 26 is a cross-section view of the handpiece cartridge and spacing ring of FIG. 24;

[0114] FIG. 27 is a perspective view of a disposable cartridge;

[0115] FIG. 28 is a cross-section view of the disposable cartridge of FIG. 26;

[0116] FIG. 29 is a perspective view of a needle bundle coupled to the disposable cartridge of FIG. 26;

[0117] FIG. 30 is a schematic view of elements of the system;

[0118] FIG. 31 is a block diagram of a controller;

[0119] FIG. 32 is a perspective view of an oscillating motor;

[0120] FIG. 33 is a perspective view of a drive system having a rotational drive motor and a flexible shaft coupled to a handpiece;

[0121] FIG. 34 is a sectional view through the rotational axis of the drive motor, the flexible shaft and the handpiece of FIG. 33;

[0122] FIG. 35 is a perspective view of the handpiece and the disposable cartridge decoupled;

[0123] FIG. 36 is a perspective view of the handpiece and disposable cartridge coupled together;

[0124] FIG. 37 is a sectional view of the handpiece and the disposable cartridge decoupled;

[0125] FIG. 38 is a sectional view of the handpiece and disposable cartridge coupled together showing the mechanical relationships of the parts;

[0126] FIG. 39 is a sectional view of the handpiece and the disposable cartridge decoupled;

[0127] FIG. 40 is a sectional view inside the handpiece showing the mechanical relationships of the various parts;

[0128] FIG. 41 is a perspective view of the handpiece with the handle removed showing the rotational housing and the alignment tabs located on the disposable cartridge;

[0129] FIG. 42 is a perspective view of the rotational housing of the handpiece coupled to the disposable cartridge;

[0130] FIG. 43 is a transparent perspective view of the internal components of the handpiece with a rotational housing and a rotational drive; and

[0131] FIG. 44 is a transparent perspective view of the handpiece illustrating a rotational shaft moved forward toward a proximal end of the handpiece causing displacement of the needle bundle.

[0132] It will be appreciated that the drawings are illustrative and not limiting of the scope of the invention which is defined by the appended claims. The embodiments shown accomplish various aspects and objects of the invention. It is appreciated 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 presented to separately illustrate the various details of the invention in greater clarity. Similarly, not every embodiment need accomplish all advantages of the present invention.

[0133] While the disclosure is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. However, it should be understood 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.

[0134] Throughout the description, similar reference numbers may be used to identify similar elements.

DETAILED DESCRIPTION

[0135] It will be readily understood that the components of the embodiments as generally described herein and illustrated in the appended 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 present disclosure but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

[0136] Reference throughout this specification to features, advantages, or similar language does not imply that all of the features and advantages that may be realized with the present invention should be or are in any single embodiment of the invention. Rather, language referring to the features and advantages is understood to mean that a specific feature, advantage, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, discussions of the features and advantages, and similar language, throughout this specification may, but do not necessarily, refer to the same embodiment.

[0137] Unless otherwise indicated, the terms “first,” “second,” etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to, e.g., a second item does not require or preclude the existence of, e.g., a “first” or lower-numbered item, and/or, e.g., a “third” or higher-numbered item.

[0138] Additionally, instances in this specification where one element is “coupled to another element” can include direct and indirect coupling. Direct coupling can be defined as one element coupled to and in some contact with another element. Indirect coupling can be defined as coupling between two elements not in direct contact with each other but having one or more additional elements between the coupled elements. Further, as used herein, securing one element to another element can include direct securing and indirect securing. Additionally, as used herein, “adjacent” does not necessarily denote contact. For example, one element can be adjacent to another element without being in contact with that element.

[0139] In the above description, certain terms may be used such as “up,” “down,” “top,” “bottom,” “upwards,” “downwards,” “upper,” “lower,” “horizontal,” “vertical,” “left,” “right,” “over,” “under” and the like. These terms are used, where applicable, to provide Some clarity of description when dealing with relative relationships. But these terms are not intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” surface can become a “lower surface simply by turning the object over. Nevertheless, it is still the same object. Further, the terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise. Further, the term “plurality” can be defined as “at least two.”

[0140] Unless otherwise indicated, the terms “first,” “second,” etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to, e.g., a second item does not require or preclude the existence of, e.g., a “first” or lower-numbered item, and/or, e.g., a “third” or higher-numbered item.

[0141] The schematic flow chart diagrams and method schematic diagrams described above are generally set forth as logical flow chart diagrams. As such, the depicted order and labeled steps are indicative of representative embodiments. Other steps, orderings and methods may be conceived that are equivalent in function, logic, or effect to one or more steps, or portions thereof, of the methods illustrated in the schematic diagrams.

[0142] Furthermore, the described features, advantages, and characteristics of the invention may be combined in any suitable manner in one or more embodiments. One skilled in the relevant art will recognize, in light of the description herein, that the invention can 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.

[0143] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the indicated embodiment is included in at least one embodiment of the present invention. Thus, the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.

[0144] While many embodiments are described herein, at least some of the described embodiments allow for the efficient removal of tattoos, permanent makeup, and other indelible mark or pigment on and under the skin, whether they were applied deliberately (as in tattooing) of were acquired naturally (as are pigmented lesions and dermal scarring). While the description herein refers primarily to tattoo removal, the apparatuses, systems, and methods described herein may be also be utilized for tattooing or other treatments to the skin of a client. Two broad classes of treatments that can be accomplished by the embodiments described herein include superficial dermabrasion (for scar revision and for removal of tattoos, permanent makeup, pigmented lesions, etc) and axial needling or aesthetic microneedling (for tattooing, skin tightening, wrinkle removal, etc).

[0145] Throughout this disclosure, reference will be made to facilitating 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 appropriate facilitating fluid as would be understood by one of ordinary skill in the art, whether that fluid is Teprsol® or another fluid. The facilitating fluid may be any liquid solution formulated to aid the system in performing its various superficial dermabrasion and/or axial needling procedures, and the formulation may change and be fitted to particular procedures.

[0146] References throughout the disclosure to dermal penetrative and shear forces may be generated by either blades, needles, brushes, or similar implements that may engage in three mechanical motions: fast oscillatory axial motions, slow positional axial motions, and slow rotation lateral motions. Note that “fast” and “slow” are relative terms. The term “axial” means substantially along the treatment needle axis, and the term “lateral” means perpendicular or transverse to the treatment needle axis. The system may automate treatment procedures by programming four independent degrees of freedom: the three mechanical brush motions and a facilitating fluid flow.

[0147] In accordance with embodiments of the system, FIG. 1 illustrates a flow chart exhibiting elements of the system for use in the application and removal of tattoos and other skin treatments comprising a cartridge assembly 1, a handpiece 2, a system controller 3, a foot controller 4 and a wearable wrist controller 5. Each of these elements may be varied in design, component arrangement, materials, and construction without deviating substantially from the functions described herein. The system controller 3 comprises a power input/output 6, wherein the system derives power from an external source such as a wall outlet. The system controller 3 monitors and sets voltage values for the operation of a drive system 15, as shown in FIG. 2, that may be either enclosed within the housing or situated externally. The system controller 3 comprises a microprocessor 7 featuring microprocessor controls, memory storage, operations controls, and monitoring functions. The microprocessor 7 provides instructions to other components in the system controller 3.

[0148] The system controller 3 may comprise 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 connections to the handpiece 2, touch control, power controls and other inputs from the user and outputs to the user. The I/O section 8 also enables wireless communication 9 via a remote-control unit on the wearable wrist controller 5. Moreover, the I/O section 8 processes data communications feedback 10 from the handpiece 2 indicating the correct operation, measurement, and control of the speed of oscillation, measurement and control of the rotation motor, and the position motor feedback location and position. Each component may provide feedback that is input to the microprocessor 7.

[0149] The microprocessor 7 interfaces with and controls the various components of the system in accordance with computer code, programming, and instructions that are stored and executed within microprocessor. The microprocessor 7 interfaces with the graphics processing unit 11 that translates instructions and programs into graphical images that can be interpreted by the user for operation of the device. The graphics processing unit 11 communicates with a graphical display on a graphic processor interface 12 with takes instruction sets and presents them in picture form to a user. In response, the user can then react to the picture form and provide input to the microprocessor 7 via the graphics processing unit 11 using the graphic processor interface 12.

[0150] The system controller 3 may further comprise a communications interface. If external devices are attached and are to be controlled, the graphic processor interface 12 provides that interface between various elements including the foot controller 4 or the wearable wrist controller 5 and a fluid pump 13. Other items as listed in the discussions below might include automatic control of the handpiece by optical or switch control operated by the clinician. Communication between components may be provided by various wireless control methodologies such as Bluetooth or Wi-Fi. A handpiece control 14 may control the oscillation, rotation, and depth of a needle bundle 49, as illustrated in FIG. 15. The operation and control of the needle bundle 49 controls the interaction at the surface of the patient's skin where treatment occurs.

[0151] As illustrated in FIGS. 2-6, embodiments of the handpiece 2 may comprise a housing 78. The housing may include first and second housing portions 78a, b that are connected with each other and that provide protection and containment for internal components. Housing portions 78a, b may be removable as necessary for maintenance and reassembled as needed to perform their function. Features may be formed on an outer surface of the housing 78, such as grip elements or ventilation holes 84. The handpiece 2 is couplable to the controller via a flexible cable routed to a connector 16 on 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 and motion controls may be routed through the controller 14 of the handpiece 2 which is connected to each sub system.

[0152] Embodiments of the handpiece 2 may comprise a handle portion 19. Attached to a handle 19 may be an auxiliary grip 18 that can be attached to or adjacent a lower surface 79 of the handle. The Auxiliary grip 18 may be attached by a dovetail mating feature 80 or other appropriate connection. This auxiliary grip 18 is held as a stabilizer when the thumb and pointer finger of the technician grip the handle 19 in one or more recesses 56 that may be positioned near an end of the handle portion 19 adjacent to a disposable cartridge 37. The auxiliary grip 18 extends into the technician's hand and may be semi-gripped by the remaining fingers of the hand.

[0153] Embodiments of the handpiece 2 may comprise a vertical frame 17 that holds or connects various components of a drive system 15 in position and alignment. Fasteners 81 may extend through the first housing portion 78a to the second housing portion 78b. Fasteners 81 may extend through or connect with apertures 82 in the vertical frame 17 positioned in an interior cavity created at least in part by the first and second housing portions 78a, b. In exemplary embodiments, on the distal end or top of the frame 17 is a block 21 that holds a lift mechanism 83 of the drive system 15 in place.

[0154] Embodiments of the lift mechanism 83 are illustrated 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 other gears that are attached to a first stepper motor 23. The first stepper motor 23 provides rotational motion to the gear train 24 that interfaces with the lead screw shaft 25. The rotational motion of the first stepper motor 23 rotates the lead screw shaft 25 which is connected to an oscillation drive frame 50, thereby positioning the drive on the vertical frame 17 in the position set by the system controller 3. Linear bearings 51 are fitted to the carriage to allow it to smoothly be positioned as needed. The distance traveled or the position with regards to height is measured by a slotted signal ring 52 and read by sensors on a printed circuit board 26. The limit of travel for the oscillation drive frame 50 is measured by hall effect devices 31 that may be mounted on the oscillation drive frame 50. At each end of travel are magnets coupled to the vertical frame 17 that communicate with the hall effect devices 31 thereby setting the limits of travel or setting position. Power for the first stepper motor 23 is sent from the handpiece controller 14 that receives motor voltages through the flexible cable connected at the connection shaft assembly 16.

[0155] Returning to FIGS. 3-6, embodiments of the drive system 15 may also comprise an oscillation drive 85. This drive 85 may comprise an oscillation motor 22 that is speed controlled with signals from the microprocessor 7 that are transmitted first to the handpiece controller 14 and then to a brushless motor commutator. As further illustrated in FIGS. 9-10, on an end of the shaft 86 of the oscillation motor 22 is an eccentric crank 28 that is rotated by the oscillation motor 22. Coupled to the eccentric crank 28 is a wire rod 29 that extends out from the eccentric crank 28 and through a rotational block 34 and interfaces with a drive rod 30 within a drive rod 38 of the cartridge. When the wire rod 29 is held in an aperture 87 of the rotational block 34, rotational motion is reduced to a linear motion. This linear motion is used to drive the needle bundle 49 in a linear motion to impinge the tissue of the recipient when the needle bundle 49 is placed against the treatment site tissue.

[0156] The oscillation motor 22 is mounted in the oscillation drive frame 50 that can be moved in a linear motion due to its riding the vertical frame 17 and sliding on the linear bearings 51. The oscillation drive frame 50 may be moved and positioned anywhere within a specified range controlled by the hall effect devices 31 and magnets mounted on the vertical frame 17. This vertical motion allows the needle bundle to be positioned with the tips even with the cartridge end or projecting a specific amount as determine by the treatment parameters. (See FIGS. 10-11.) Counterweights 88 on the eccentric crank 28 reduce the vibration from the oscillation motor drive to make operation comfortable to the technician.

[0157] FIG. 10 illustrates a relationship between embodiments of the oscillation drive 85 and the cartridge 37. This figure also shows an embodiment of an additional drive 89 which causes rotation of the drive rod 30 which transmits that rotational motion to the drive rod 38 on the cartridge. Embodiments of this drive impart rotational motion as described in the operational discussion to the needle bundles. This rotational motion may replace hand motion performed by the technicians during the abrasion process. Rotational motion is started by driving a second stepper motor 32 which transmits that motion to a gear combination 36. The gear combination is secured to the rotational block 34 that is suspended in radial bearings 53. When the second stepper motor 32 is rotated, the rotational block 34 also rotates at a 1:1 ratio. The center of the rotational block 34 has a hexagonal aperture within its center. The drive rod 30 is fitted into the block and has a similar hexagonal form to it. When the rotational block 34 is rotated, the drive rod 30 rotates. The amount of rotation and the speed of rotation is measured by sensors positioned to look at a signal wheel 33. When the rotational signal is sent from the microprocessor, the handpiece controller 14 receives that signal and provides direction and speed information to the second stepper motor 32 to rotate the rotational block 34. The cartridge drive rod 38 comprises an interface slot 35 that transmits the motion received from the drive rod 30 to the cartridge drive rod 38.

[0158] FIG. 9 also shows male interface features 90 that are used to transmit motion from the drive rod 30 to the cartridge drive rod 38 in embodiments of the drive system 15. These interface features 90 may comprise tabs extending from an exterior surface of the drive rod 30 to engage with corresponding slots 91 formed in the cartridge drive rod 38. Since the oscillation motion and the rotational motion are controlled separately and merged into the rotational block and drive rod assembly, both motions are independently controlled and can be merged into compound motions of linear and rotational motion which is transferred to the needle bundle 49.

[0159] FIGS. 10-14 illustrate embodiments of the disposable cartridge 37. The disposable cartridge 37 may comprise several molded parts assembled together and sterilized prior to use. A housing 92 of the disposable cartridge 37 may be made from a molded plastic material that is durable and that can be sterilized. The molding may comprise polycarbonate, an ABS/polycarbonate blend, or similar polymer. The housing may comprise a protruding side 41 comprising a locking feature 93. The locking feature may comprise tabs or extensions 94 that are adapted to engage female threads formed on an inside surface of an engaging luer lock. The locking feature enables tubing sets that transmit fluids to traverse through the joints with little chance for leakage. Within the locking feature is a small bore 44 that enables fluid that is introduced at the locking feature to be transmitted down to the end of the cartridge at the end of the needle bundles, where the abrasion or treatment takes place. A smaller integral aperture 55 is added to the cartridge passage to limit the flow of the Teprsol® fluid during operation. This will prevent free flow of the fluid onto and around the treatment site possibly wasting fluid or allowing too much fluid to be released during treatment.

[0160] In further embodiments, the housing also has upon it raised features 40 that ensure that the disposable cartridge 39 can be only installed one way and is secure during operation. A recess in the raised feature interfaces with a retainer button 20 located on the handle 19 which securely holds the cartridge during treatments. (See FIG. 3.) Once locked in place the vibration that occurs during use will not be sufficient to cause these parts to separate during the treatment. On the distal end of the cartridge is a molded spring 39 that presses against a disposable cartridge mount surface 95 in the handpiece and the spring pressure keeps the disposable cartridge 37 from vibrating during use. This spring force also enables the disposable cartridge 37 to be ejected following treatment, with an advantage of reducing the chance of the technician accidentally contacting the needles/blade.

[0161] The disposable cartridge 37 may also comprise a cylindrical feature 96 on the distal end that is the location for the attachment of a spacer ring 42. The tolerances of the cylindrical feature and the spacer ring 42 together allow the two to be mated and remain coupled throughout the treatment cycle. The treatment ring 42 may help the technician space the tegula one from another to allow the skin bridge remaining between tegulae to remain and promote correct healing. The protruding side 41 on a top of the disposable cartridge 37 is the location of a flexible tubing connection 54. The flexible tubing connection 54 is a connection for a tubing set to be attached which allows the pump and fluid dispensing 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 seated within and protected from damage by the cylindrical flange surrounding the needle bundle 49.

[0162] The smaller integral aperture 55 on a passage of the disposable cartridge 37 limits the flow of the Teprsol® fluid during operation. This will prevent free flow of the fluid onto and around the treatment site possibly wasting fluid or allowing too much fluid to be released during treatment. The disposable cartridge 37 further comprises a spring 45 that assists the needle bundle 49 to retract during the treatment process. The retraction may ensure that the needle bundle 49 can rotate freely during the treatment. Rotation of the needle bundle 49 may occur before total retraction of the needle bundle 49 if desirable to do so. Alternatively, the disposable cartridge 37 may not comprise a spring, or the spring 45 may serve only to ensure that the assembly internal components are maintained in a proper position. In such embodiments the drive mechanism, including the drive rod 38, may directly drive the needle bundle rod 46 in extension and retraction such that the reciprocating motion does not depend on the action or return force of the spring 45.

[0163] A seal 47 that prevents excess Teprsol® fluid from exiting to the back of the disposable cartridge 37. Any excess fluid that enters this portion may exit the chamber through an aperture 56. At proximal end of the disposable cartridge 37, a needle interface rod 38 provides interface with components of the handpiece 2 for linear as well as rotational motion. The components of the handpiece 2 travel in a linear motion that directly moves the cartridge drive rod 38 in a linear travel, thus moving a needle bundle rod 46 in a linear travel. When placed against the skin of the recipient, the needle bundle 49 when acted upon in a linear motion through the cartridge drive rod 38 and the needle bundle rod 46, will extend from the distal end of the disposable cartridge 37 and pierce the skin of the recipient.

[0164] FIGS. 13-14 illustrate embodiments of the needle bundle 49. The needle bundle 49 may be sized larger in diameter or smaller with a high density of needles or a low density of needles being spaced closely or sparsely depending upon the treatment type being performed. It is contemplated that a needle bundle may be designed in other patterns other than circular, such as triangular mount or square mount with various needle patterns on them along with various densities of needles. The embodiment of FIGS. 13-14 shows an offset linear pattern. Other patterns would be understood by one of ordinary skill in the art. The needle holder or bundle rod 46 supports the needle bundle 49 and provides the interface of the needle bundle 49 to the drive components along with strength to press needles into the skin of the recipient. The needle bundle rod 46 may be molded from a plastic material while the needles may be machine inserted and molded in place or hand inserted and molded in place. For sparse needle configurations, the needle bundle rod 46 may comprise holes with the needles hand placed and secured with adhesive.

[0165] Embodiments of the needle bundle rod 46 interface with the cartridge drive rod 38 within the housing of the cartridge and are secured by a snap fit. The rear of the needle bundle rod 46 has a hexagonal feature 58 that ensures that the two parts when assembled will be able to be rotated as one part. The needle bundle rod 46 comprises a hexagonal interface feature 58 that interfaces with a mating feature 57 of the cartridge drive rod 38. The hexagonal interface features 58 mating together ensures that rotational motion will be translated to needle bundle.

[0166] Embodiments of the cartridge housing further comprises a locking tab 43 which locks the linear travel of the needle bundle rod 46 and the 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 needles/blades from extending during installation of the cartridge into the handpiece. It is removed after installation of the disposable cartridge 37 and can be discarded or retained for reinstallation when the disposable cartridge 37 is ready to be ejected and discarded.

[0167] As illustrated in FIGS. 14-15, the needle holder may include a generally cylindrical shaft 97 that extends from a needle face 98 at a distal end of the holder to the hexagonal interface 58 at the proximal end. Locking tabs 99 or another locking feature may extend from the proximal end of the interface 58. The locking tabs 99 may engage corresponding features on or adjacent to an end of the mating socket 57 of the cartridge drive rod 38. Ridges 171 may extend from a sidewall of the shaft 97 to engage an interior surface 172 of the disposable cartridge. The ridges 171 may comprise a first, proximal section 173 and a second, distal section 174. The distal section may extend farther from the shaft 97 surface and may have an end surface 175 that is coplanar with the needle face 98. The shaft 97 is illustrated as cylindrical but may, alternatively, have a triangular, rectangular, obround, or other cross-sectional shape.

[0168] As illustrated in FIGS. 15 and 16A-E, one or more needle bundles 49 may extend from the needle face 98. Needle bundles 49, blades, or individual needles may be attached at the needle face. For example, a needle bundle may be inserted into a recess 176 formed in the needle face. The needle bundle may be attached by inserting the needle bundle into the recess and securing it by adhesive, press fit, or other mechanisms. Alternatively, the needle holder 46 may be injection molded around the needle bundle so that the needle bundle is 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 to be inserted.

[0169] Embodiments of the needle holder 49 are illustrated in FIGS. 16A-E, including various combinations and arrangements of needles or blades. For example, the needle packs can be arranged as a singlet 59, a couplet 60, a triplet 61, or a quadruplet 62. If single needles are desired for certain types of applications, the single needles can be grouped or spaced in a grid or pattern configuration 74 having a plurality of needles in a grid formation extending outwards from a center region. Alternatively, a needle holder may be provided with 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 need or preference. It will be appreciated that the potential arrangements can vary depending upon the application for the cartridge and what positions are filled in the needle holder.

[0170] FIGS. 17A-C illustrate elevation views of embodiments of needle/blade configurations. A compact linear configuration 63 may orient a group of needles in a tight single layered arrangement. Such groupings can be installed in the recess 176 in the needle face 98 with various arrangements depending on the molded portion. Alternatively, a spaced linear configuration 64 may orient a group of needles spaced apart from one another without touching or overlapping needles. A staggered configuration 65 may orient a group of needles in two or more rows with the needles in a first row offset spatially from the needles in a second row. The needles in the second row may similarly be offset from needles in subsequent rows.

[0171] FIGS. 18A-F illustrate elevation views of embodiments of needle assemblies having various configurations. A needle assembly 66 may comprise a securement end 233 and a penetration end 234. The securement end 233 may comprise one or notches 240 that aid in securing the needle assembly to the needle holder 46. The penetration end 234 may comprise one or more individual needles or a plurality of blades or points 68. The tips of the plurality of blades 68 may be cut with laser energy or may be manufactured from chemical etching processes or similar techniques. A recess or cavity 177 may extend into or through the blade 67. The cavity may reduce the mass or improve the strength, rigidity, or stability of the blade 67. The needle assembly 66 may comprise a flat surgical material that is cut or etched at an angle in one direction to cut a needle or sawtooth shape and ground in the other direction to achieve a sharp needle like shape.

[0172] The plurality of blades 68 may feature a uniform spaced configuration 69 in a single row. The plurality of blades 68 may be manufactured by similar means as razor blade processing, creating the taper of the tips with a grinding process to achieve a sharp edge having deeper roots on the blade tip spacing. This allows the plurality of blades 68 to penetrate deeper without the root of the plurality of blades 68 striking the surface of the tissue being impinged. A variable spacing configuration 70 may be created using mathematical spacing calculations such as logarithmic or geometric spacing algorithms. Such spacing may aid in the abrasion as the blade is oscillated linearly while being spun on the axis. An angled configuration 71 may orient the blades at varying heights along a linear axis. Similarly, a curved angle configuration 72 may orient the blades at varying heights along a curved axis. Since the design of the plurality of blades 68 is not limited to a mechanical hand assembly, the design of the plurality of blades 68 has many more options available for fitting other applications in addition to just tattoo removal. For example, a deep recess configuration 73 may comprise recesses along a longitudinal axis between shafts of the plurality of blades 68 similar to needles. The deep recess configuration 73 is conducive to allowing the needles or plurality of blades 68 to be more flexible. Additionally, the spacing may help retain fluids such as ink or pain management analgesics. The deep recess configuration 73 may also be used for artistic tattoo applications or for permanent makeup applications. FIGS. 18A-F illustrate embodiments of the blade 67 having a generally flat, linear configuration formed from a single piece. However, the blade may also be bent or otherwise shaped into other configurations such as a “C,” “N,” “O,” “W,” or other shape. Alternatively, the blade may be formed from multiple pieces to form a multi-leg shape, such as a “Y” or “+” shape.

[0173] As illustrated in FIG. 30, embodiments of a system comprise a cartridge assembly 101, a hand piece 117, a drive connection 103, a drive 104, a system controller 105, a foot controller 106, and a remote controller 107. As illustrated in FIGS. 19-29, the cartridge assembly 101 may comprise a disposable cartridge 143 comprising a needle bundle 152. The drive connection 103 may comprise a connection shaft assembly 116; and the drive 104 may comprise a drive system 115. Embodiments of the system controller 105, as seen in FIG. 31, may comprise a power supply 109 that obtains power from external sources such as wall outlets. The power supply 109 controls and sets voltage values for the operation of the drive system either enclosed within the housing or externally. A processor 110 of the controller may contain microprocessor controls, memory storage, operations controls, monitoring functions and provides instructions to the other components in the control system. One output of the processor 110 section may be to provide I/O control 114.

[0174] I/O control 114 may provide an interface with the external components of the system such as connections to the drive, touch control, power controls and other inputs from the user and outputs that the user can operate with. One of the I/O control 114 functions may be enable user control by the remote controller 107, which may be a wrist controller. Another I/O control 114 function may be to provide feedback from the drive 104 indicating correct operation and measurement and control of the speed of oscillation, measurement and control of the rotation motor, and the position motor feedback location and position. Each of these parts has feedback that is fed to the processor 110 and the processor 110 maintains control based upon the programs and instructions that are stored and executed within.

[0175] The processor 110 interfaces with a graphic controller 111 that may function to translate instructions and programs into graphical image that can be interpreted by the user for operation of the device. The graphic controller 111 communicates with a graphic display 112 which takes instruction sets and presents them in picture form. The user can then respond and react to the graphic format and provide input to the processor 110 via the graphic display 112 and its interface component the graphic controller 111.

[0176] The system controller 108 may also comprise a communications interface 113. Communications within the system controller 108 is internal and linked by software or hardware controls. If external devices are attached and are to be controlled, the communications interface 113 may provide that interface. Interface with various elements may include a switch on the foot control 106 or other elements on the remote wrist controller 107. Other components or functions may include automatic control of the handpiece 117 by optical or switch control operated by the technician. Various wireless control methodologies such as Bluetooth, or Wi-Fi may be used such that the control system need not be tethered to its parts, such as the wrist controller 107 or the foot controller 106.

[0177] In some embodiments, as shown in FIGS. 19-20, the device may comprise a drive system 115, a connection shaft assembly 116, and a handpiece 117. The drive system 115 may control the oscillation, rotation, and depth of a needle bundle. The connection shaft assembly 116 transfers driving motion from the drive system 115 to the handpiece 117 assembly, to which is attached a cartridge housing that contains the needle bundle. As illustrated in FIG. 20, the drive system 115, connection shaft assembly 116, and handpiece 117 may be separated for construction as well as use and maintenance. These items can be separated if necessary and reassembled as needed to perform their function. The separation allows for different assemblies to be substituted as needed for repair or for upgrade of function.

[0178] Referring to FIGS. 21-22, the drive assembly 115 may comprise various subsystems, including an oscillation drive, a rotational drive, and a distance or depth drive. In embodiments of the system, a frame 132 holds the various components in position and alignment. Embodiments of the system may comprise a rotational drive in which on the distal end of the frame 132 is a holding block 178 that holds a driven pulley 130 in position. A belt 121 may connect the driven pulley 130 with a drive pulley 131. A stepper motor 120 may rotate the drive pully 131 that, in turn, rotates the driven pulley 130 by means of the belt 121. A drive interface block 123 may be connected with the driven pulley 130 such that the interface block rotates at the pulley rotates. The interface block 123 may engage with the connection shaft assembly 116. The rotational motion is transmitted by the connection shaft, ultimately to the needle bundle. The stepper motor 120 receives instructions from the processor 110 either through a hard connection cable or by wireless communication. Power for this motor is provided by the power supply 109 as are all the motors within the drive sub-system.

[0179] Embodiments of the drive system may also comprise an oscillation drive. The oscillation drive may comprise an oscillation motor 124 that may be a brushed or brushless DC motor that is speed controlled by the processor 110. On the end of the shaft 180 of the oscillation motor 124 is an eccentric crank 118 that is rotated by the oscillation motor 124. Attached to the crank is a wire rod 122 that extends out from the crank and through an aperture in the pulley 130 and interfaces with a flexible rod 140 within the flexible connection shaft 134 (see FIG. 23). When the flexible rod 140 is held in an aperture, the rotation motion is reduced to a linear motion. This linear motion is used to drive the needle bundle 152 in a linear motion to impinge the tissue of the client when the needle bundle 152 is placed against the treatment site tissue (see FIG. 26).

[0180] Embodiments of the system may comprise a depth drive in which the oscillation motor 124 is mounted in a carriage 129 that can be moved in a linear motion due to its riding on two control rods 126, 127. The carriage can be moved and positioned along the length of this set of control rods. The drive for this position is provided by a depth stepper motor 119 that has attached to it a threaded rod 128. The carriage 129 has an aperture 181 with an interior female thread that interfaces with the threaded rod 128.

[0181] Thus, when the depth stepper motor 119 is repositioned, the carriage 129 is moved either toward the motor 119 or away from the motor. The position of the carriage 129 is monitored by an optical encoder 125 and sensor. The grating of the encoder can allow position of the carriage 129 to be monitored. If desired the motor 119 may incorporate an internal encoder to monitor position of the carriage. As with all other drive components on the drive sub-system, power is obtained from the power supply 109 located within the system controller 108 and are monitored and controlled by the processor 110. Graphical representations of the drive status may be displayed on the graphical display 112, to indicate to the user correct and desired operation of the components.

[0182] As illustrated, for example, in FIGS. 23 and 30, the connection shaft assembly 116 may comprise a flexible shaft that can allow positioning of the components within the treatment area of the clinic as well as provide freedom of motion and travel for the technician when placing the handpiece 117 and a cartridge 143 on a client's body. Embodiments of the connection shaft, as shown in FIG. 23, comprise a flexible outer sheath 133 that keeps the items within contained and clean from dust and debris. A proximal end 138 of the flexible connection shaft 134 interfaces with the drive sub assembly 115 and the distal end interfaces with the sub assembly of the handpiece 117. Within the shaft are a flexible tube 139 and a flexible rod 140. The flexible tube 139 has on each end an interface receiving feature 136 that interfaces with the interface block 123 of the drive assembly 115 and a rotational interface feature 146 on the handpiece 102. The interface features 123, 136 transfer rotational motion from the drive assembly 115 to the handpiece 117. The ends of the flexible connection shaft 134 may comprise threaded features or quick disconnect features 135 that secure the ends of the shaft at the drive and handpiece ends. Within the center of the flexible tube 139 inside the flexible outer sheath 133 is housed the flexible rod 140. The flexible rod 140 is driven by the linear motions of the drive sub assembly which translates the linear motion ultimately to the needle bundle 152. An end 137 of the flexible rod 140 interfaces with features within the handpiece 117 that translate linear motion to the cartridge assembly 101 and the needle bundle 152.

[0183] Embodiments of the handpiece 117 and cartridge 143 are shown in FIG. 24. The handpiece 117 may comprise a grip or housing 141 with a collar 142 that functions as an adjuster on the end of cartridge 143 and a spacer ring 144. The handpiece sub assembly may comprise interface components 146 that interface with the flexible connection shaft for the translation of linear, and rotational motion to the cartridge 143 and the needle bundle 152.

[0184] As illustrated in FIGS. 25-26, the rotational interface feature 146 at the proximal end of the handpiece 117 may accept rotational motion from the flexible connection shaft. The rotational interface feature 146 can rotate freely within the housing 141 of the handpiece 117. A bearing 147 may allow the sliding action of linear motion whilst maintaining interlock for control of rotational motion. This is where a mixing of rotational and linear motion may be performed within the handpiece 117.

[0185] In further embodiments, control of distance of linear stroke may be accomplished in the handpiece 117 instead of the drive assembly 115. Accordingly, the collar 142 may comprise a threaded feature 148 that interfaces with the housing 141 of the handpiece 117. This threaded feature may comprise stops on its rotational adjustment to prevent the collar from unthreading from the handpiece housing. The collar 142 may comprise marks that indicate coarse adjustment of the depth of needle impingement at the treatment site. Embodiments of the system may use either one or both adjustment features. Alternatively, the collar 142 may be a slider collar with detents indicating depth of needle impingement. The handpiece interface 145 may comprise a female interface feature 189 that engages a male feature 190 of the cartridge 143 and translates the motion to the needle bundle 152 within the cartridge 143.

[0186] As illustrated in FIGS. 24-26, the cartridge 143 may comprise a spacer ring 144 that is generally “hat-shaped,” and has an aperture 191 that allows it to be placed on the end of the cartridge 143 and remain during the vibration that occurs during the treatment process. The spacer ring 144 may further comprise a disc 192 that can be places on or adjacent to a treatment site. The spacer ring 144 may be made from a clear plastic material and treatments may be done with or without the spacer ring 144 in place. The spacer ring 144 may provide a visual spacing cue and may help the technician space the tegula one from another to allow the skin bridge remaining between tegulae to remain and promote correct healing.

[0187] As illustrated in FIGS. 27-28, the cartridge 143 may comprise a multi-part plastic molded assembly. In accordance with embodiments of the system, a proximal end 193 of the cartridge housing 149 is cylindrical in form and engages in a press or other fit with the handpiece 117 to maintain correct interface and prevent unwanted friction of the motion drive. This cylindrical portion 193 of the cartridge housing 149 may comprise two ramped obround features 150 extending from the cylinder body. These features allow the cartridge housing 149 to be rotated and locked into place in the proximal end of the handpiece 117 that is also obround in shape. Once locked in place, the vibration that occurs during use will not be sufficient to cause these parts to separate during the treatment.

[0188] The cartridge 143 may also comprise a cylindrical feature 151 on the distal end that is the location for the attachment of the spacer ring 144. Tolerances of this feature and ring together allow the two to be mated and remain throughout the treatment cycle. On the top of the cartridge 143 is a flexible tubing set 153 that may be short as shown with a luer lock feature attached or be long and have the luer lock feature spaced a distance from the cartridge, preferably several feet away from the cartridge. In a further embodiment, the cartridge 143 may have the luer lock feature molded onto the cartridge where the tubing is attached, thereby eliminating the tubing assembly.

[0189] Within the distal end of the cartridge 144, the needle bundle 152 is seated within and protected from damage by the cylindrical flange 194 surrounding the needle bundle 152. Within the cartridge housing 149, a fluid passage 155 interfaces with the flexible tubing set 153. Through the flexible tubing set 153 and the fluid passage 155, Teprsol or other facilitating fluid may be administered to the treatment site during tattoo removal. An integral aperture may be added to the fluid passage 155 to limit the flow of the Teprsol fluid during operation. This may prevent the free flow of the fluid onto and around the treatment site possibly wasting fluid or allowing too much fluid to be released during treatment. Also, the cartridge housing 149 may comprise a spring 154 that ensures the needle bundle 152 retracts during the treatment process. The retraction may ensure that the needle bundle 152 can rotate freely during the treatment. Rotation of the needle bundle 152 may occur before total retraction of the needle bundle 152. Alternatively, the cartridge 144 may not comprise a spring, or the spring 154 may serve only to ensure that the assembly internal components are maintained in a proper position. In such embodiments the drive mechanism, including the needle interface rod 156, may directly drive the needle bundle 152 in extension and retraction such that the reciprocating motion does not depend on the action or return force of the spring 154.

[0190] A seal 159 may reduce or prevents excess Teprsol fluid from exiting to the back of the cartridge. Any excess fluid that enters this portion may exit the chamber 195 through a hole 160. At the proximal end of the cartridge 143, needle interface rod 156 provides interface with handpiece components for linear as well as rotational motion. When the handpiece parts travel in a linear motion that motion directly moves the interface rod 156 in a linear travel, thus moving the needle bundle rod 157 in a linear travel. When placed against the skin of the client, the needle bundle 152 when acted upon in a linear motion through the interface rod 156 and needle bundle rod 157, will extend from the distal end of the cartridge and pierce the skin of the client.

[0191] As illustrated in FIG. 29, the needle bundle 152 may be attached to a forward face 198 of the needle bundle rod 157. The needle bundle may be sized larger in diameter or smaller with high density of needles or low density of needles being spaced closely or sparsely. The needle face 198 may be designed in other patterns other than circular, such as triangular mount or square mount with various needle patterns on them along with various densities of needles. The embodiment of FIG. 29 shows the needle bundle 152 in a cross pattern. Other patterns would be understood by those familiar with the art.

[0192] The needle rod 157 supports the needle bundle 152 and provides the interface of the needle bundle to the drive components along with strength to press needles into the skin of the client. The rod may be molded in a plastic material and the needles may be machine inserted and molded in place or hand inserted and molded in place. For sparse needle configurations as described above, the needle face 198 may comprise a pattern of holes and the needles hand placed and secured with adhesive. The needle rod 157 interfaces with the interface rod 156. The two parts are assembled within the housing of the cartridge and are secured by a snap fit. The rear of the needle rod has a male hexagonal feature 196 that engages a corresponding female hexagonal feature 197 formed in interface rod 156 such that the two parts when assembled rotate as one part. The interface rod 156 may comprise an interface feature 158 that engages with the handpiece interface 145. The hexagonal features ensures that rotational motion will be translated. It will be understood that other feature shapes may be used, including square, triangle, rectangle, obround, or other appropriate shapes.

[0193] As illustrated in FIG. 32, embodiments of an oscillation motor 161 may comprise a shaft 162 that rotates when voltage is applied to the motor from a drive section 235 of a controller 170. The drive section 235 of the controller 170 may apply a high voltage or long duty cycle to the motor to make it attain the speeds necessary for the treatment parameters contained within controller memory. The shaft 162 is connected to a crank 166, to which a bearing 167 allows a wire drive 168 to maintain its aligned position for driving a flexible rod 169. The shaft may comprise a disk 163 with a slot 164 or multiplicity of slots. The location of the slot 164 or features is sensed by a sensor 165 which may be optical, a magnetic device or a physical interface such as a cam follower. The output of the sensor 165 is sent to the controller 170. The controller with this information may coordinate the motion of the needle rotation in synchronization with the oscillation. This information may also be used for retracting the needle bundle upon completion of a treatment or during treatment pauses for repositioning the cartridge to another treatment site. Rotation of the needle bundle may be performed in a predetermined manner based upon treatment parameters or may be used to control the force of the rotation as a method of enhancing the treatment. Accordingly, additional abrasion may shorten the treatment time and provide the same tissue effect in tattoo removal as when the operator manually moved the needles during the treatment.

[0194] As shown in FIGS. 33-34, in some embodiments, a drive system 201 may comprise a flexible shaft 208, a handpiece 209 couplable to a disposable cartridge 210, and a drive motor 203 that may be rotated to be in alignment with a center axis of the flexible shaft 208 and coupled to a central drive wire 207 located in the center of the flexible shaft 208 via a coupling 205. The drive motor 203 may further be coupled to a movable carriage 202 on a far side of the drive assembly 201, allowing the drive motor 203 to be moved as shown along a linear axis 204 towards or away from the flexible shaft 208. The linear axis 204 allows the drive wire 207 to change position relative to the distal end of the flexible shaft 208. Coupling the drive motor 203 rotational coupling 205 to the drive wire 207 causes the drive wire to rotate. A flexible sheath or inner housing 219 surrounds the drive wire 207 is rotated by a stepper motor 238 and a gear combination 206 located on a face 239 of the drive system 201. The gear combination thereby translates rotational motion into the flexible shaft using a gear coupling 211.

[0195] Embodiments of the flexible shaft 208 comprise an outer sheath 236, an inner sheath 219, and the drive wire 207. The inner sheath 219 may comprise a rotational coupling 212 on a proximal end, located within the handpiece 209 that is driven by the gear coupling 211. The gear coupling 211 translates rotational motion to the inner sheath from a first end to a second end of the flexible shaft 208. The drive wire 207 is coupled to the drive motor 203 by the coupling 205. As connected in this fashion, the drive wire 207 may be rotated at any speed by the drive motor 203 translating that rotational motion to the rotational coupling 212 located within the handpiece 209. The drive wire 207 and the inner sheath 219 may rotate independently. The rotation of the inner sheath 219 in the flexible shaft 208 may be independently driven by the gear combination 206. Accordingly, all three motions are translated to the flexible shaft 208 and transferred to other inner components located within the handpiece 209.

[0196] As illustrated in FIGS. 35-37, the disposable cartridge 210 may comprise a follower 215 and locking ridges 214 positioned on a distal end of the disposable cartridge 210. The handpiece 209 may also comprise a recess 216 on a proximal end that receives the locking ridges 214 on the distal end of the disposable cartridge 210. Once inserted into the recess 216, the disposable cartridge 210 may be rotated slightly to secure and lock the handpiece 209 and the disposable cartridge 210 together as one single unit.

[0197] The flexible shaft 208 is couplable to a needle bundle 218 which in turn can be attached or removed from the handpiece 209. At the distal end of the handpiece 209, the inner sheath 219 may terminate into the rotational coupling 212. The drive wire 207 may likewise terminate and be secured in a coupler 220. The drive wire may be inserted into a recess 221 in a proximal end of the coupler 220. When the drive wire 207 is rotated at the drive motor 203 this motion is translated to the coupler 220. It will be appreciated that the design of the drive system 201 allows the service and assembly of the handpiece 209 or the flexible shaft 208 independently of one another, while still being able to translate rotational motion into linear motion once assembled.

[0198] Within the handpiece 209, the coupler 220 may be coupled to a swashplate 224. The swashplate 224 may be manufactured from a hardened material that is resistant to wear through use, such as a hardened polished steel or similar metals or alloys. Also, the swashplate 224 may comprise a sliding 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 may be coupled to a bearing retainer 227 and a rotational housing 223. The rotational motion from the flexible shaft 208 is then transferred from the coupler 220 to the swashplate 224 and the rotational motion is transferred from the rotational coupling 212 coupled to the rotational housing 223 through the bearing retainer 227.

[0199] To ensure that the rotation motion from the drive wire 207 is translated with minimal friction, the swashplate 224 rotates within a first radial bearing 225 and a second radial bearing 226. It will be appreciated that this rotation ensures that accurate and free motion is available to operate the drive system 201. The first and second bearings 225, 226 may be preloaded to ensure proper rotational freedom by a second compression spring 222. The first and second bearings 225, 226 are retained by the bearing retainer 227, which may be a separate piece to allow installation of the first and second bearings 225, 226 during the initial assembly of the drive system 201. After assembly, the bearing retainer 227 may be coupled to the rotational housing 223, ensuring that the rotational components are both secure and operate freely for motion translation.

[0200] The follower 215 may be rigidly coupled to the needle bundle 218. The handpiece 209 may comprise a compression spring 217 that pushes the follower 215 away from the disposable cartridge 210 and maintains 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 pushed toward the disposable cartridge 210 causing the compression spring 217 to become compressed. When released, the follower 215 will naturally return to the initial position at rest, fully retracting the needle bundle 218 into the disposable cartridge 210. Alternatively, the handpiece may not comprise a spring, or the spring 217 may serve only to ensure that the assembly internal components are maintained in a proper position. In such embodiments the drive mechanism, including the drive wire 207, may directly drive the needle bundle 218 in extension and retraction such that the reciprocating motion does not depend on the action or return force of the spring 217.

[0201] As illustrated in FIGS. 38-40, embodiments of the disposable cartridge 210 may be coupled to the handpiece 209. When coupled together, the follower 215 impinges on the swashplate 224. As the swashplate 224 is rotated, the follower 215 is pushed from an initial position at rest, thereby compressing the compression spring 217 and causing the needle bundle 218 to also move forward and be exposed from within a housing of the disposable cartridge 210. Next, as the swashplate is rotated fully, the follower 215 engages the surface feature of the swashplate 224, causing a displacement of the follower 215 from one extreme of the swashplate 224 profile to the other. This rotational motion of the swashplate 224 translates the motion of the follower 215 into linear motion, causing the needle interface rod 237 and needle bundle 218 to either extend or retract. The conversion of linear motion allows the needle bundle 218 to impinge the patient's skin surface to perform the linear needle motion during the abrasion process. Therefore, the rotational motion from the drive wire 207 is translated into linear motion at the needle bundle 218.

[0202] A coupling feature 231 of the bearing retainer 227 mates with the coupler 220 that is driven by the inner sheath 219 in the flexible shaft 208. Because the bearing retainer 227 and the rotational housing 223 are coupled to one another, when the inner sheath 219 is driven in a rotational fashion by the gear combination 206 of the drive system 201, the rotational motion is transferred to the coupler 220 which in turn rotates the bearing retainer 227 and the rotational housing assembly 223. The rotational housing 223 is free to rotate within the handpiece housing 209 and to prevent its departure from the housing 209 is retained by a retainer ring 228.

[0203] As illustrated in FIG. 41, the coupler 220 may rotate the bearing retainer 227 and the rotational housing 223. The rotational housing 223 may comprise slots 232. As the rotational housing 223 rotates within the handpiece 209, the slots 232 and anything within the slots 232 will rotate. The follower 215 may comprise tabs 230 that are comparable in size and width to fit within the slots 232 on the rotational housing 223.

[0204] As illustrated in FIGS. 42-43, the follower 215 may be aligned for assembly with the disposable cartridge 210 such that the tabs 230 on the follower 215 are inserted into the slots 232 on the rotational housing 223. In embodiments of the system, the rotational coupler 223 rotates independently of the handpiece housing 209, and the follower 215 located in the disposable cartridge 210 and coupled to the needle bundle 218 also rotates, being driven by the tabs 230 and slots 232 of the rotational housing 223. Thus, it will be appreciated that in some embodiments, the linear motion of the needle bundle 218 can be performed via the swashplate 224 being rotated and the follower 224 being driven by that motion. The rotational motion of the follower 215 may be simultaneously performed via the rotation of the rotational housing 223, independent of the handpiece housing 209.

[0205] In tattoo removal, it is desirable to vary the depth that the needles can operate during the abrasion process. Tattoo ink depth varies from one patient to another and there is no set distance for ink depth since all skin physiology varies across the board from patient to patient. Thus, embodiments of the device allow needle penetration to be varied to accommodate patients of all physiologies. The depth may be varied and controlled to ensure the depth is known and repeatable or can be counted on to be accurate. The carriage 202 is moveable and accurately positioned allowing the drive motor 203 to be positioned relative to the handpiece 209. Since the drive wire 207 is rigid and moves freely within the flexible shaft 208, any position of the drive motor 203 in the drive assembly 201 will translate into the end of the drive wire 207 being moved or positioned as desired withing the handpiece 209. To vary the position of the needle bundle 218 in the disposable cartridge 210, a method is employed to move the needles by moving the impinging features of the swashplate 224 and follower 215. In this case the wire drive coupler is moved by the drive wire being repositioned.

[0206] As illustrated in FIG. 44, embodiments of the system comprise a rotational shaft that may be moved forward toward a proximal end of the disposable cartridge 210 causing displacement of the needle bundle 218. The repositioning process pushes on the distal end of the swashplate 224, pushing it away from the bearings, which repositions the face of the swashplate 224, thus pushing the follower into the disposable cartridge 210 and thus repositioning the needle bundle 218. With these items repositioned, due to the drive motor 203 position, in the drive assembly 201, the depth of the needle bundle 218 may be controlled during its stroke and rotation. The compression spring 217 located in the distal end of the rotational housing 223 and the bearing assembly 227 also acts to retract the swashplate 224 when returning to the initial position at rest. It will be appreciated that the drive assembly 201 enables the motion of the disposable cartridge 210 and, ultimately in the tattoo removal process, needle linear motion for abrasion, needle rotational position or rotational motion enhancing the abrasion, and needle depth control and position relative to the surface of the patient's skin. In some embodiments, the swashplate 224 may be incorporated into a condensed version that would allow the drive motor 203 to be housed within the handpiece and perform the functions as described above.