Tattoo Removal Pattern Needles and Cartridges

Abstract

The disposable cartridge may be used in conjunction with skin abrasion for tattoo removal. The cartridge may include a needle bundle driven in a reciprocating or reciprocating / rotating motion to ablate dermal tissue during the tattoo removal process. The needle bundle may include a plurality of needles arranged in a circular pattern such that each needle abuts and touches an adjacent needle. The needles may be arranged around a central arbor to form a ring of adjacent needles. Alternatively, the needle bundle may include tubular needles having sharp tips formed at the ends of the tubes. The disposable cartridge used in conjunction with skin abrasion for tattoo removal may also include a seal / spring / retainer combination element that stretches and springs back to its original shape to provide a spring action and a sealing function to reduce or prevent the release of fluids used in the tattoo removal process.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to the following U.S. provisional patent applications: 63 / 444,183, filed February 8, 2023; 63 / 522,095, filed June 20, 2023; and 63 / 534,423, filed August 24, 2023, each of which is incorporated herein by reference.

[0002] FIELD OF THE INVENTION Embodiments of the present invention relate to needles for tattoos and tattoo removal, and more particularly to hollow circular pattern needles or needle sharp tubes for abrasion and tattoo removal. Further embodiments of the present invention relate to cartridges for tattoos and tattoo removal, and more particularly to cartridges having a combination of a spring and a sealing element. [Background technology]

[0003] (background) When a tattoo is created, tattoo ink is introduced into the recipient's epidermis and dermis using a series of ink-coated reciprocating needles. The desired ink color is delivered to the recipient's dermal layer of tissue through the cavities and grooves in the roughened tips of the needles by impacting the tissue. The ink is then deposited, and the ink will remain in place throughout the recipient's life. The ink may be very vibrant at the time of insertion and may remain so for many years. However, as the recipient ages, the color fades over time, shifting toward a dark blue or black hue. Additionally, as the recipient ages, they may lose interest in and desire for the tattoo, or life changes may even require them to modify or remove a tattoo that they once considered highly desirable. Such life changes may motivate the recipient to change the shape, wording, or color of the image in the tattoo, or even motivate the recipient to desire removal.

[0004] Many employers, including the U.S. military, have tattoo art requirements that do not allow visible tattoos. These requirements only allow such art to be covered while in uniform, or place restrictions on the recipient's content or scope when obtaining employment or representing the employer's interests. Some people may want to remove their tattoos for reasons other than employment.

[0005] Additionally, limited research has been conducted on the chemical properties of some of the inks used in tattoo art, and it has been found that some of these inks may have long-term harmful effects on organs such as the liver. Ink that is shed in tissues may be transported by the lymphatic system to the liver, where it remains for the recipient's lifetime. These chemicals may be toxic if allowed to remain. If this is a concern for the recipient, and if the recipient has additional motivation, it may be advantageous to remove the tattoo by some means to alleviate health concerns.

[0006] Several methods have been developed for tattoo removal, including, but not limited to, laser bombardment of ink pigments within the skin, dye or skin peels or bleaching agents. Known methods may include removing tattoos by peeling or by creating a tegula, however, methods to achieve a repeatable peeling process have been unsuccessful, resulting in scarring or discoloration of the replacement tissue produced by the body's healing properties.

[0007] Other known methods may improve the uniformity of exfoliation and promote natural healing, which reduces the likelihood of scarring. One method has been to use the same tools commonly used to apply tattoos. Using a reciprocating tattoo needle can offer the advantage of maintaining uniform removal of the epidermis and partial dermis where the tattoo ink is placed. This may include the advantage of better exfoliation or removal of tissue, but may still result in scarring.

[0008] It is also known that when abrasions are separated by islands, regrowth of virgin tissue surrounding the abrasion allows scarring to be reduced and ink removal to be possible. A flexible stencil may be used to determine the diameter of the abrasion in a controlled ratio to the skin islands. In this way, controlled abrasion occurs, providing islands of structure that allow the abrasion to heal evenly around its periphery. Such islands may allow the body's natural healing process to regenerate the removed tissue around the abrasion at a controlled rate. Furthermore, other chemical liquids may be added to the abrasion to help improve the abrasion process and improve healing.

[0009] A process that has shown good success in creating peeling and healing is the TEPR™ system, a trademark of Rejuvatek Medical Inc. This system uses a stencil that is placed over the recipient's tattoo location by the clinician. The clinician then marks predetermined holes in the stencil using a biocompatible dermatological marker. The clinician then removes the stencil and attaches a needle bundle cartridge to a reciprocating handpiece. The clinician also attaches a fluid control clip to the cartridge and then adds a syringe containing an enhancing fluid, such as Teprsol™, a trademark of Rejuvatek Medical Inc., to the line attached to the cartridge. The clinician then places the syringe into a pump and fills the line to the cartridge.

[0010] Once the line is filled, the clinician energizes the handpiece and places the tip of the cartridge against the tattooed skin while administering Teprsol™ to the ablation site. Teprsol™ aids in the ablation process by softening the tissue being ablated by the reciprocating needle. The clinician then moves the needle around the area marked by the marker until the epidermis is removed, exposing the dermis containing the tattoo ink. Once the ablation reveals the smooth surface that forms the ablation and the ink bed is exposed, the clinician moves their attention to the next treatment site for ablation. Once the clinician has completed all treatment sites identified and marked using the stencil, a topical ointment and pain reliever are applied. The site is then bandaged to allow for scab formation.

[0011] The healing process using the TEPR™ System can take several weeks as a scab or eschar forms and tissue regenerates beneath. As the scab dries and falls off, the ink that was exposed during peeling is found within the scab. Once the scab is removed, fresh new tissue that formed beneath the scab is revealed. After this treatment area is completely healed, the clinician returns the recipient, and the clinician replaces the stencil on any remaining untreated areas on the tattoo, marking them as before and peeling them off as before. Using this process, most tattoos can be removed within three treatment cycles without the scarring that formed before this process was developed. Patents and published applications related to this method include U.S. Patent Nos. 8,663,162, 10,500,013, 10,610,327, 11,020,203, 11,529,505, and U.S. Design Registration No. D974,552, as well as U.S. Patent Application Publication Nos. 2020 / 0108240, 2021 / 0106398, 2021 / 0113296, 2021 / 0244496, 2023 / 0211138, and 2023 / 0211139, each of which is incorporated herein by reference.

[0012] Other known processes, such as bleaching, typically only lighten the tattoo and are only successful in lightening the color. These are usually not successful on older tattoos. The color of these tattoos typically bleeds and darkens over time. While laser methods may offer some effectiveness, because there is no tissue removal, the tattoo ink is not removed from the body and may remain in the recipient's body for the rest of their life. The laser process also has the drawback of pain associated with burning the cellular structures that hold the tattoo ink. Because lasers operate with a specific wavelength of light, only tissues that quickly and cleanly absorb the light heat quickly enough to boil the intracellular fluids containing the ink, thereby releasing the ink into the recipient's circulatory system. Once released, any ink-stained ash or debris remaining in the dermis is removed by the body's circulatory system, just like other dead cellular structures in the body. Because the resulting heating is below the epidermis and cannot be observed by the clinician, the clinician may not heat the area sufficiently to remove the ink or may overheat the area and cause burns. The resulting burns can be painful and can cause scarring as they heal.

[0013] Thus, significant benefits are enjoyed with the TEPR™ peeling system under the direct observation of a clinician in terms of pain and healing outcomes for the recipient. Because the system is designed to require these types of needle bundles and cartridges, it is important that the operation of the cartridge and handpiece combination, along with the application of Teprsol™, be controlled, simplified as much as possible, and designed to prevent undesirable leakage or challenges in providing the resulting peel results desired for successful, reproducible tattoo removal and healing potential.

[0014] In tattoo removal using known peeling techniques, clinicians use a specific process for tattoo removal. First, the technician evaluates the client's tattoo by observing the embedded color, color density, skin folds, wrinkles in the patient's treatment area, and the flexibility of the client's skin in the tattooed area. After evaluation, the clinician drapes the area adjacent to the area to be treated to prevent infection or Teprsol™ irritation used during the procedure from affecting other areas of the client's skin. The clinician may then apply a topical pain reliever to help the client manage pain during the treatment. After applying the medication, the clinician may apply a proprietary stencil to the tattooed area to be treated, as shown, for example, in U.S. Patent Nos. 8,663,162 and 10,500,013. The clinician then marks the openings on the stencil using a biocompatible marker used in dermatological treatments. After marking the desired openings on the stencil, the stencil is removed, and the clinician then prepares the peeling tools necessary for tattoo removal.

[0015] The primary tool used in the stripping process is a needle bundle mounted in a single-use disposable cartridge. Within this cartridge, a set of seven rigid wire needles is arranged along the axis of the cartridge. The needle pattern consists of one needle surrounded by six other needles in the center, which are tangential to the central needle, with each needle in the group tangential to the others. This group of needles is bundled together and secured to a coaxially mounted plastic stem, which interfaces with a tattoo removal vibrating handpiece tool. This needle bundle is mounted within a disposable single-use cartridge that is attached to a motor-driven handpiece.

[0016] Needle bundle embodiments include those disclosed in U.S. Patent Nos. 10,610,327 and 11,529,505. The stem of the needle bundle extends from the proximal end of the cartridge and interfaces with an oscillating drive mechanism within a handpiece used by a technician. Components within the handpiece include a motor drive that, when powered, drives against the ends of the needle bundle stems to generate reciprocating linear motion of the needle bundle. The sharp (pointed) tips of the needle bundle, extending from the distal end of the disposable cartridge, are then adjusted to a specified distance from the cartridge's outlet opening.

[0017] Once set, the tip of the needle is placed against the client's tattooed skin. The clinician selects one of the markings previously made with the marker and uses that and other markings as a guide for the size and spacing of the abrasions to be created for the tattoo removal process. While the needle bundle is driven by the handpiece, a fluid such as Teprsol™ is applied to the needle and treatment site while the clinician moves the needle bundle in a circular / spiral motion, starting at the center and spiraling out from the center or edge of one of the previously made marks to a distance of 2.5 mm, then rotating around the mark and then spiraling back to the center.

[0018] While this ablation is occurring, the technician observes the epidermal tissue removal, fluid flow, and viscosity of the wound bed being created due to ink marks embedded within the tissue being removed. At this point, once satisfied that the ablation is complete and uniform and the wound is homogeneous, the clinician towels off the wound and then selects another mark for the next ablation. The ablation process is repeated for each of the marks made until the clinician has completed the pattern. This completes the ablation process using the 7-needle pattern.

[0019] The process of evaluation by the clinician and the setup process by marking the area to be treated, as indicated by the stencil and the clinician's experience, can take several seconds per spot and may require multiple passes of the needle bundle. The time required for marking prolongs the peeling process, and in complex tattoo removal cases, the process can take from several minutes to 15 minutes (1 / 4 hour) just for marking. To add to the process time, each marking intended for treatment has a specific peeling performance pattern that has developed over the years due to the diameter size of the needle bundle used. With the known seven-needle bundle, the combination of circular and spiral motion of the needle bundle can require up to 15 seconds per peel spot or tegra, and even longer depending on the resulting tegra formation.

[0020] A method that reduces peel time, simplifies peel patterns, and increases the rate at which a technician must remove epidermal tissue for each tegula identified using a stencil would be advantageous, since faster times to perform peeling can reduce treatment time and better aid salon profitability and patient comfort. If the technician's needle bundle manipulation pattern could be simplified to fewer or even just one circular pass while still providing uniform peeling, this would speed up the peeling process, allowing for more treatments per day and helping clients spend less time dealing with needle impacts on their body. Therefore, there is a need for different settings for usable needle and stencil pattern creation that can speed up tegula generation, thereby reducing treatment time. [Prior art document] [Patent documents] [Patent Document 1] U.S. Patent No. 8,663,162 [Patent Document 2] U.S. Patent No. 10,500,013 [Patent Document 3] U.S. Patent No. 10,610,327 [Patent Document 4] U.S. Patent No. 11,020,203 [Patent Document 5] U.S. Patent No. 11,529,505 [Patent Document 6] U.S. Design Registration No. D974,552 [Patent Document 7] U.S. Patent Application Publication No. 2020 / 0108240 [Patent Document 8] U.S. Patent Application Publication No. 2021 / 0106398 [Patent Document 9] U.S. Patent Application Publication No. 2021 / 0113296 [Patent Document 10] U.S. Patent Application Publication No. 2021 / 0244496 [Patent Document 11] U.S. Patent Application Publication No. 2023 / 0211138 [Patent Document 12] U.S. Patent Application Publication No. 2023 / 0211139 Summary of the Invention

[0021] (overview) Embodiments of the device may be used to remove tattoos using ablation as a removal method. An embodiment may include a needle bundle consisting of multiple needles arranged on a central axis of the device, the needles arranged tangentially to one another in a pattern, attached to a stem that interfaces with a reciprocating handpiece. The tip of the device is placed against the epidermal tissue to be ablated, containing the tattoo, and the needles are driven in a reciprocating motion within the tissue by the handpiece. During needle impact, Teprsol™ fluid is introduced through a fluid port to the ablation site, which helps improve the ablation process. The cartridge unit, including the needles and the interface for Teprsol™ delivery and reciprocating needling, is a self-contained device, closed and manufactured to prevent excessive Teprsol™ loss to surrounding tissue due to the irritating effect of Teprsol™.

[0022] An embodiment of the device is comprised of several parts assembled into an assembly. The assembly may include a housing surrounding a central axial bore with openings at each end and an angled tubular feature projecting at an angle from the top of the housing. The top tubular feature may include a hollow bore extending downward from the proximal end to and intersecting with the main axial bore. The proximal end of the tubular structure may be formed with a tapered female inlet including a tab for locking a mating component. This feature may include, or may be referred to as, a luer lock, which allows the mating parts to form a seal that can withstand high pressures while being easily removed and changed as needed. The use of a luer lock may have the advantage of eliminating the need for an additional fluid control clip.

[0023] The distal end of the housing may include mating features for a tapered tip with a central opening. This tip holds the needle in a selected pattern and holds the needle in place during the ablation process. The tapered tip may allow the clinician to view the needle's movement just outside the needle bundle, the state of the ablation as it forms, and monitor the flow of Teprsol™ delivered to the site. The tip and housing can be made of an opaque material, but are preferably made of a translucent or transparent material. When so constructed, the tip and housing may allow the clinician to monitor the flow and observe any resistance to the flow of Teprsol™.

[0024] The proximal end of the housing may include two features: 1) a barrel body fitted with an axial bevel that increases in height as the part changes angle on its axis; and 2) an internal bore that extends from the end all the way to the center and has a central wall or septum with a central opening. The axial bevel on the barrel may allow the barrel body to be inserted into a reciprocating handpiece and twisted on its axis until the axial bevel locks into the body of the handpiece. The angle deploys to interfere with an oblong feature in the handpiece, thereby locking the barrel and housing into the handpiece at a specified angle each time it is inserted.

[0025] A guide may be inserted into the central bore where the wall or septum is located. This guide may help keep the needle bundle axially oriented with the central bore of the housing. This alignment may help prevent the needle bundle from rubbing or sliding against the inner wall of the housing. The guide is preferably made from a plastic with natural lubricity, such as nylon, polyethylene, or Delrin™. These materials may provide a low-friction surface for the needle bundle to remove therethrough, thereby reducing wear or friction during reciprocation.

[0026] The needle bundle may be located on the central axis of the housing. The bundle may include groups of needles with diameters of 0.3 mm to 0.2 mm arranged tangentially to one another in groups of 7, 9, or 13 needles. The needle groups may be secured within a stem. The stem of the device is preferably a plastic tubular section having a long cylindrical section at its proximal end and a small-diameter receptacle at its distal end. The distal end includes a blunt end of the needle group that is installed within the device. The needle group is preferably secured within the small-diameter receptacle using adhesive, a locking ring, a tube, or other suitable mechanism. Once secured within the receptacle, the needle bundle acts as a single-piece assembly.

[0027] The distal or non-open end of the stem may interface with a reciprocating drive within the handpiece. By displacing the end of this stem while within the housing, the needle group oscillates in a linear motion. This movement, with the sharpened needle tips, impacts the recipient's tattooed epidermis and dermis, creating ablation.

[0028] The base of the needle in the bundle may interface with a flexible cylindrical section having a hole on the needle side and a larger diameter annular section at the opposite end. The base of the needle may be inserted through the hole in the rubber cylinder, and a surface with a small opening on the stem may be pressed against the inside of the cylinder. After this insertion, a rigid cylinder retainer ring may be inserted over the end of the needle stem and into a stop surface within the rubber cylinder. After assembly, the needle, stem, and rubber cylinder may be inserted into the proximal bore of the housing and pushed into the bore until the annular section of the rubber cylinder stops against the end of the housing, thereby forming a stop.

[0029] An advantage of the stopper is that it can form a seal or resistance against possible backflow of Teprsol™ toward the handpiece when the distal end of the housing becomes blocked or clogged. Such a seal may reduce or prevent contamination of the handpiece, reducing or preventing Teprsol™ leakage, thereby reducing corrosion of the handpiece's internal components. Such a seal may perform a variety of functions. It may perform a centering return spring action to help keep the needle bundle centered and positioned within the housing. It may act as a seal to reduce the possibility of undesired Teprsol™ backflow and also as a stopper to retain components installed within the housing. It may also bias the needle bundle to a rearward position so that the sharp tip of the needle or needle tube retracts into the distal end of the housing in a manner that prevents or reduces puncture injuries to the clinician during cartridge installation and after removal.

[0030] Among other advantages of embodiments of the present invention, when larger in diameter than known tattoo needle bundles, circular pattern needles ablate more epidermis and dermis at a faster rate than traditional needle patterns used due to the diameter coverage. The diameter of the circular pattern or tube can be up to half the planned ablation site and can be operated by the clinician in a simple circular motion rather than the longer spiral patterns traditionally used for skin abrasions and miniature needle bundles. The embodiments discussed herein may include needle patterns, uses, and methods of construction.

[0031] BRIEF DESCRIPTION OF THE DRAWINGS 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 accompanying drawings. The subject matter will be described and explained with additional specificity and detail through the use of the drawings, with the understanding that these drawings depict only typical embodiments of the subject matter and therefore should not be considered limiting of its scope. [Brief explanation of the drawings]

[0032] [Figure 1] FIG. 1 is an exploded perspective view of an exemplary embodiment of a needle bundle assembly.

[0033] [Figure 2] 2 is a perspective view of the needle bundle assembly of FIG. 1 in an assembled state.

[0034] [Figure 3] FIG. 3 is an exploded perspective view of components of a further exemplary embodiment of a needle bundle assembly.

[0035] [Figure 4] 4 is a perspective view of the needle bundle assembly of FIG. 3 in an assembled state.

[0036] [Figure 5] FIG. 5 is a perspective view of a further exemplary embodiment of a needle bundle assembly.

[0037] [Figure 6] FIG. 6 is a cutaway perspective view of an exemplary needle bundle assembly assembled within a housing.

[0038] [Figure 7] FIG. 7 is a perspective view of an exemplary embodiment of a needle tube.

[0039] [Figure 8] FIG. 8 is a perspective view of an exemplary needle tube assembled to a stem, including a detailed view of the tip.

[0040] [Figure 9] FIG. 9 is a cutaway perspective view of an exemplary needle tube assembly assembled within a housing.

[0041] [Figure 10] FIG. 10 is a front perspective view of a cartridge according to an embodiment of the device.

[0042] [Figure 11] 11 is a rear perspective view of a cartridge according to the embodiment of the device of FIG. 10. FIG.

[0043] [Figure 12] 12A is a front orthographic view of a cartridge according to the embodiment of the device of FIG.

[0044] FIG. 12B is a top (upper) orthographic view of a cartridge according to the embodiment of the device of FIG.

[0045] 12C is a side orthographic view of a cartridge according to the embodiment of the device of FIG.

[0046] 12D is a rear orthographic view of a cartridge according to the embodiment of the device of FIG.

[0047] [Figure 13] 13 is a cross-sectional view of a cartridge according to the embodiment of the device of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0048] (Detailed explanation)

[72] Embodiments of the present invention are described in detail below. Referring to the drawings, like reference numerals refer to like parts throughout. As used throughout the description and claims of this specification, the following terms have the meanings expressly associated therewith in this application (herein), unless the context makes clear otherwise: the meanings of "a," "an," and "the" include plural references, and the meaning of "in" includes "in" and "on." Relationship terms, such as first and second, top and bottom, front and back, etc., may be used only to distinguish one entity or action from another, and this usage does not necessarily require or imply an actual such relationship, direction, or order between such entities or actions.

[0049] The terms "proximal" and "distal" are used throughout this application when describing various embodiments. These terms are not intended to be limiting and are merely provided to facilitate maintaining a consistent orientation when describing various embodiments. As used herein, proximal refers to a direction generally closer to a user of the cartridge, and distal refers to a direction generally further from the user.

[0050] The term Teprsol™ is used throughout this application to describe an enhancement fluid useful in various embodiments for tattoo peeling and removal, or other skin markings. Those skilled in the art will appreciate that the enhancement fluid may be Teprsol™, a trademark of Rejuvatek Medical Inc. Alternatively, the enhancement fluid may be another suitable fluid, as will be appreciated by those skilled in the art.

[0051] An embodiment of the device of the present invention may include a circular pattern of sharp needles or sharp points on a hypodermic tube that can be used to ablate the epidermis. This arrangement of needles or sharp points on the tube creates a hollow circular pattern, eliminating the central needle present in other, smaller circular patterns, such as the known pattern of seven round adjacent needles. An embodiment of a ring pattern of needles may include sharp needles arranged tangentially to one another in a circular pattern. The circular hollow pattern created by such a tangential arrangement is maintained by the pressure of the needles against one another within a restraining tube and / or by positioning the needles against an arbor or central pin whose diameter is such that the needles maintain a tangential relationship between the arbor and each needle in that arrangement and are then restrained in that position by a restraining tube or retainer. If the central arbor is large enough in diameter, it may be part of a shaped stem that is used to drive the needle bundle in a linear oscillatory motion when placed in a holder such as a cartridge housing and then driven by a handpiece set up to receive the stem and housing and drive the attached needles.

[0052] An embodiment of the needle or sharp tube point array may consist of any number of needles arranged in a ring pattern, or any number of sharp points on the end of the tube. Due to the small diameter typically associated with hypodermic tubing and the final size of the resulting tegara, the diameter of the tube will preferably not exceed half the diameter of the final tegara, which is approximately 2.5 mm in diameter. Due to the small diameter of the tube, a uniform number of points may be created so that a cutter, such as a wire EDM device, can cut the tip. This allows for the formation of tapered cuts on both ends of the tube. Such cutting of the tube can also be performed using a laser cutter.

[0053] An additional advantage of the circular tube bundle is that the Teprsol™ used to aid in the ablation process can enter the side of the tube through radially arranged slots to aid in the ablation process, in addition to being delivered to the treatment site where it can be released around the tube near the tip of the plastic housing. The additional flow of Teprsol™ may allow the ablation process to occur more easily and may help prevent fluid blockage that occurs in the needle bundle where ablated tissue occurs when the needles are arranged tangentially in a seven-circular pattern.

[0054] When needles are used in a ring array embodiment, 7 to 22 needles may be used to form a circular pattern. The needles may be hollow or solid wired needles. The needles may preferably have a diameter of 0.2 to 0.5 mm, more preferably 0.3 mm. Alternatively, the needles may have other diameters, shapes, or configurations as described herein or as understood by those skilled in the art. The arrangement of 22 needles in a circular pattern allows a clinician to ablate slightly more than half of a 5 mm diameter tegara. Provided that the needle vibration is consistent with applications using approximately 8,000 punctures per minute, the motion pattern performed by the clinician may be simplified to only a circular motion for a large pattern of 22 needles. The simplified motion and larger ablation area can provide a clinician with a way to simplify needle manipulation and speed up the ablation process by removing more tissue due to the larger diameter of the needle group when compared to known needle bundles.

[0055] Needle bundles constructed in accordance with embodiments of the present invention, including a central arbor with needles positioned tangentially to the sides of the arbor, can be fabricated in a number of ways. An example shown in the figures may include an assembly with needles positioned relative to a molded plastic stem, with the arbor extending to and controlling the location of the needles. The needles are then positioned with their tips pointing away from the proximal end of the stem, positioned tangentially to the arbor, and secured with a metal shrink ring.

[0056] Alternatively, a separate wire arbor may be inserted into a tubing sleeve sized to securely hold a predetermined amount of needles and arbors, and then surrounded by the needles to fill the pattern. The needles extend from the distal end of the tubing, which may be secured to the proximal end of the needles with adhesive or a specialized crimping tool. After the needles are crimped or secured to the arbor and tubing, the needle bundle can be inserted and secured with adhesive to a stem having a mating receptacle that can accept the needle bundle. Such an embodiment allows for the length of the tubing and arbor to be varied to add flexibility to the needles by using shorter tubing and arbors, or for the flexibility of the needles to be limited by increasing the length of the tubing and arbor. This variation allows for better control of the needle spread and flexibility during manufacturing, allowing the needle bundle to be tailored to the ablation application. This variation allows for better control of the needle spread and flexibility during manufacturing, allowing the needle bundle to be tailored to the ablation application.

[0057] An embodiment of the dissection device may use a disposable plastic housing, which is a plastic molded part having a retention mechanism on the proximal end and an opening on the distal end through which the needle can protrude during vibration.

[0058] An embodiment of the ring needle design includes a needle, arbor stem combination, and a retaining ring or tube that holds the needles tangentially to each other and to the central arbor stem. The needle array may include different numbers of needles, including from 7 to 25 needles, and more preferably from 9 to 22 needles. The upper limit of the needle bundle diameter is half the diameter of the proposed detachment site. Above that diameter, the resulting ligament will not heal as well, and the extra movement will not add anything to the final detachment result.

[0059] According to an embodiment of the present invention, when placed within the cartridge housing and attached to the drive handpiece, the needle bundle vibrates and is placed against the epidermis containing the tattoo, causing ablation of the epidermis containing the tattoo ink when Teprsol™ fluid is applied to the treatment site.

[0060] FIG. 1 shows various components of a circular needle bundle 5 and associated stem 4 in an exploded format, in a disassembled state. As discussed above, embodiments may include multiple needles 1. The multiple needles may include individual needles 1a, 1b arranged tangentially. The needles 1 may be arranged so that the outer surface of one needle abuts an adjacent needle. Each needle may have a sharpened distal end 63 and a proximal end 64. One or more locking rings 2 may surround the multiple needles and secure them relative to an arbor or central pin 3 so that the needles reciprocate and / or rotate in conjunction with the arbor or central pin 3. The pin 3 may extend from or form part of the stem 4 to which the needles are attached.

[0061] The stem 4 provides a drive rod 65 that interfaces with a handpiece that includes a reciprocating drive. The stem 4 may also include a stepped section 49 that provides a connection between the stem distal portion 46 and the drive rod 65. The diameter of the stepped section 49 may be larger than the stem distal portion 46 and the drive rod 65 and may increase and decrease in one or more steps 66, 67. The center pin 3 may extend from a distal surface 68 of the stem distal portion 46. The proximal end 64 of the needle may abut the stem distal surface 68. Alternatively, the proximal end 64 of the needle may be inserted into one or more cavities formed in the distal surface 68 or may be embedded within the stem 4 at the distal surface 68. The stem 4 may be molded or machined from a plastic or other suitable material.

[0062] Figure 2 shows the needle bundle 5 assembled and secured to the stem 4. Once assembled, the needle bundle can be inserted into a cartridge housing for use in the stripping process.

[0063] 3 illustrates another embodiment that may employ a different construction method. In such an embodiment, needle 6 may be inserted into tube 7, and central wire arbor 8 may be placed within central cavity 69 while the needle presses against the inner wall of the tube so that the needle forms a ring 70 surrounding central cavity 69. Central wire arbor 8 may have an interference fit within the ring of the needle such that the arbor holds the needle against the inner surface of tube 7, securing the needle against movement relative to the arbor. Arbor 8 may be formed from metal wire, plastic, or another suitable material.

[0064] Figure 4 shows the completed and secured assembly of Figure 3. The proximal section 71 of the arbor may extend beyond the needle proximal end 64. This proximal section 71 may provide a location for attachment to the stem 10 (Figure 5). The tube may be spaced a distance 72 from the proximal end 64 of the needle 1.

[0065] 5 illustrates an embodiment of a needle assembly 9 attached to a molded or machined stem 10, which, when positioned within a housing, can interact with a reciprocating drive mechanism within a handpiece. The completed bundle 9 may be secured within the stem 10 using an adhesive. Alternatively, the central arbor 8 may be integrally formed with the stem 10 or attached to the stem by welding, chemical or physical bonding, or by a press fit. In the assembled position, the proximal end 73 of the tube 7 may abut the distal surface 74 of the stem step portion 49.

[0066] FIG. 6 illustrates an embodiment incorporating the needle assembly shown in FIGS. 1-5 assembled within a housing 11 that can be inserted into a handpiece for stripping. The housing 11 may include a feature or surface 12 used to secure the housing within the handpiece and a means or method for centering the needle bundle for axial control during reciprocation. Centering may be provided by a support surface 13 on the proximal end and a tapered conical tip 14 on the distal end. The housing 11 may include a conical distal section 81 through which the sharpened tip 15 or sharpened end 63 of the needle 1 extends. The distal section 81 may include a generally cylindrical end 82 extending from the distal end of the conical section 81. As shown in FIG. 6, the needle end 63 may be retracted within the end 82 when the needle bundle 5 is in the retracted position.

[0067] The surface 12 may comprise a tubular body that is inserted into and secured to a handpiece (not shown). The housing may have various features, as described below with respect to Figures 9-13, including a passageway 83 through which Teprsol™ may flow into the housing. The stem 4 may have a distal section 84 having a bore 85 formed therein for accommodating the proximal end of the needle bundle 5. The bore may have stepped portions that surround the proximal section 71 of the arbor 8 that extends beyond the proximal end of the needle 1 at a first section 86, surround the ring of the needle 70 at a second section 87, and surround the sleeve 7 at a third section 88.

[0068] One feature of the embodiment shown in Figures 4 and 5 is that the tube 7 supporting the needle bundle 9 can be made shorter or longer depending on the need for a more flexible needle. Figure 1 shows an embodiment with a needle 1 that is approximately half the length of the needle 6 of Figures 4 and 5. The embodiment of Figure 1 results in a very stiff needle depending on the diameter and modulus of the material from which the needle is made. A longer needle results in a more flexible needle.

[0069] 3 and 4, varying the length of the tube 7 and arbor 8 within the assembly allows one skilled in the art to manufacture needle bundles with specific bundle or bundle flexibility ranges that can be adjusted for various skin types. Some clinicians prefer more flexible needles, which they feel result in more uniform exfoliation. Conversely, needle bundles with longer tubes 7 and arbor pins 8 may result in less needle flexibility during vibration. The change in length may alter the stiffness and flexibility of the needle bundle.

[0070] Figure 7 shows an embodiment of a needle tube 17 used for dissection. The needle tube 17 may have a hollow body with open proximal and distal ends 51 and 52, a circular sidewall 50, and multiple sharp tips 15 formed on the distal end of the circular sidewall. The tips 15 may be sharpened on both the inside and outside of the tube and then cut into a pattern, such as the one shown, using common cutting methods for small-scale machining. The tips may be formed by cutting grooves 53 or serrations into the sharp end of the tube to form multiple tips. The grooves may have a single angle or multiple sections with different angles to create a variable-profile tip. A slot 16 opening on the side of the tube allows Teprsol™ fluid to enter the tube during the dissection procedure and helps prevent tissue buildup on or within the needle. Figure 8 shows an embodiment of a tube needle 17 attached to a stem 18, including a detailed view of the tips 15. The stem may include a drive rod 54 extending from a distal end 55 of the stem 18. The drive rod may interface with a handpiece that includes a reciprocating drive.

[0071] FIG. 9 shows an ablative needle tube installed within a cartridge housing 19. Like other embodiments of the cartridge housing 11, the embodiment shown in FIG. 9 may have a surface 20 used for retention within a mating handpiece and a central tapered tip 21 that allows the clinician to control the needle's position and location during ablation. Device embodiments with tapered tips 14, 21 may help the clinician pre-set the needle's projection beyond the end of the tip before beginning the ablation process to determine the depth of needle tip penetration during the ablation process. Teprsol™ or other fluids to aid in dermal ablation may flow into the housing 11 through an upwardly angled feature 56 with a central bore 57. The fluid may then pass through a cavity 58 within the housing 11 and through the slot 16 into the hollow body 59 of the needle tube. The stem 18 may include a distal section 60 having a bore 61 formed therein for receiving a proximal end 62 of the needle tube 17 .

[0072] Embodiments of the present invention may include needle bundles that can be arranged in a circular pattern of tangentially arranged needles with an essentially hollow middle; needle bundles that can be assembled on a mandrel or made as an assembly and attached to a stem; needle bundles that can be made with varying amounts of needles, thereby allowing for a simpler manipulation pattern to create the same ablation result desired by the clinician; needle bundles that can be made stiffer or more flexible depending on the clinician's needs for the ablation process; or needle bundles that can be assembled into a single-use disposable cartridge that can be used to ablate tissue in a shorter amount of clinician time.

[0073] FIG. 10 shows a front view of an embodiment of the device, which may include a housing 31 having an upwardly angled feature 33 that houses a bore extending downward from a Luer lock interface 34 to a central bore within the housing 31. The housing 31 may be formed in a single piece. Attached to the distal end 47 of the housing 31 is a conical tip 32 that tapers from the housing's outer diameter to a smaller diameter that includes an opening 44 through which a sharpened needle 43 ( FIG. 13 ) may pass. The main housing 31 may be manufactured from an injection-moldable plastic, such as polycarbonate or other suitable material. The durability of this material may provide the advantage of allowing the Luer lock feature to retain its strength during use and while in inventory awaiting use.

[0074] The housing 31 may further include a tubular body, extension, or feature 36 extending from the proximal end 48 and adapted to assist in positioning the device within a handpiece for use. The tubular body 36 may include one or more tapered ramps 35 aligned with the central axis of the housing. These ramps 35 may be positioned opposite each other on the tubular body 36. These ramps 35 may be adapted to engage features within the handpiece such that they interfere with the handpiece features, thereby retaining the device within the handpiece for use. Thus, installing the device within the handpiece may include inserting the tubular feature into the handpiece and rotating the device until it is retained.

[0075] An actuator rod, shaft, or other feature 37 may extend from the tubular body 36 on the housing 31. The rod 37 may be directly connected to the needle group within the center of the housing. The rod 37 may interface with a reciprocating feature within the handpiece, allowing the needle to be driven in a reciprocating motion by the handpiece when inserted and locked into place.

[0076] 11 shows a rear view of an embodiment of the device, showing the housing 31 and the upwardly protruding angled feature 33 that terminates in a luer lock feature 34. At the center of the luer lock feature 34 is an opening 40 that communicates fluid into the central bore of the housing 31. A tubular body 36 protrudes from the end of the housing 31 with a tapered, beveled section 35 positioned to lock the device in place on the handpiece. An actuator rod 37 extends from the housing's tubular extension 36 and may be attached directly to a needle bundle disposed within the housing. A bushing 38 may surround the actuator rod 37, which holds an edge of a combination spring / seal 39 that overlaps an edge of the tubular body 36 of the housing 31. The tapered tip 32 may support the needle during the stripping process.

[0077] FIG. 12 shows various views of the apparatus described above with respect to FIGS.

[0078] FIG. 13 shows a cross-sectional view of an embodiment of the device so that the internal features and components and their relationship to one another can be illustrated. This cross-sectional view shows an embodiment of the main housing 31, conical tip 32, and tubular body 36 on the proximal end of the housing 31. The main housing 31 includes an opening 40 that tapers to a Luer taper, preferably comprising a 6% taper. Opening 40 connects to a chamber 45 within the body. The chamber opens dorsally to the conical tip 32, all the way to an opening 44 on the conical tip. This set of passages allows Teprsol™ to flow from the inlet opening 40 to the conical tip opening 44. A needle bundle 43 is attached to the actuator rod 37.

[0079] When the actuator rod 37 is operated in a linear reciprocating motion, the needles in the bundle 43 move in the same linear motion. There may be a bushing 42 that may help keep the needles aligned during the linear reciprocating motion as the rod 37 is moved. If the diameter of the needle bundle is changed or the number of needles is increased from seven, the bore of this bushing 42 may be increased, as may the opening 44 in the conical tip 32. This may also keep the needles aligned with the opening 44 in the conical tip. The bushing 42 may prevent some of the Teprsol™ fluid from migrating toward the location of the actuator rod 37.

[0080] A combination seal / spring / retainer 39 may be disposed at the rear end of the tubular body 36 of the housing 31 to prevent fluid passing through the bushing 42 from exiting the rear opening of the housing. This seal, retainer, and spring combination 39 may act as a return spring to help the needles return to their original positions during reciprocating motions caused by the handpiece and acting on the actuator rod 37. This seal / spring / retainer 39 may comprise a flexible elastomeric material, such as a TPE (thermoplastic elastomer), or a rubber compound, such as a silicone resin or biocompatible rubber. The elastic properties of the seal / spring / retainer 39 may allow it to stretch and spring back to its original shape, providing a spring action. Because it seals to the edge of the inner bore of the tubular body 36, the seal / spring / retainer 39 may also prevent fluid from leaking around the edge.

[0081] A combination seal / spring / retainer 39 holds the actuator rod 37 and needle bundle 43 assembly within the housing 31. The spring, seal, and retainer combination may be held in place by a circular retainer bushing 38, which may have small barbed features around its periphery. When pressed into place, the seal / spring / retainer 39 is held in place. The diameter of the seal / spring / retainer 39 may be small enough that its inside presses against the outer diameter of the actuator rod 37, thus sealing against fluid passing between the needle 43 and the outer edge of the actuator rod 37. This sealing action may provide the advantage of reducing or preventing the expulsion of Teprsol™ into the internal working parts of the handpiece, as Teprsol™ is corrosive to metal components.

[0082] Embodiments of the device may include various features or elements, including one or more of the following: an angled connection port that connects to the main chamber for delivering fluid to the needle tip; a luer lock feature on the connection port; a seal / spring / retainer combination that provides a positive fluid seal, a return spring, and holds the components within the housing; the ability to modify the needle volume or change the needle pattern by changing the diameter of the conical tip opening and guide bushing; or a safety feature that reduces the chance of a needle stick, with a spring / seal / retainer combination that retracts the tip of the needle bundle into the conical tip.

Claims

1. 1. A cartridge for use in skin abrasion for tattoo application and removal and other skin treatments, comprising: a housing having a proximal end, a distal end, and a cavity; a needle bundle comprising a central arbor and a plurality of needles, each needle having a sharpened distal end and a blunt proximal end attached to the central arbor; a stem attached to the needle bundle and extending proximally from the central arbor, the stem having a distal end and a proximal end; Equipped with each of the plurality of needles is arranged adjacent to at least one other of the plurality of needles in a circular pattern such that the plurality of needles form a ring surrounding the central arbor; cartridge.

2. The cartridge of claim 1 , wherein each of the plurality of needles tangentially abuts an adjacent needle.

3. The cartridge of claim 1 , wherein the needle bundle further comprises a sleeve surrounding the plurality of needles and securing the needles to the central arbor.

4. The cartridge of claim 1 , wherein the needle bundle further comprises a tube that surrounds the plurality of needles and secures the needles to the central arbor.

5. The cartridge of claim 4 , wherein the tube is secured to the proximal end of the needle by an adhesive.

6. The cartridge of claim 1 , wherein the needle bundle further comprises a ring surrounding the plurality of needles and securing the needles to the central arbor.

7. The cartridge of claim 6 , wherein the ring comprises a metal ring.

8. The cartridge of claim 6 , wherein the ring comprises a shrink ring.

9. The cartridge of claim 1 , wherein the distal end of the stem includes a mating hole into which the needle bundle is inserted.

10. The cartridge of claim 1 , wherein the central arbor comprises a wire.

11. 10. The cartridge of claim 1, further comprising a tapered tip formed adjacent a distal end of the cartridge, at least a portion of the sharp distal end of each needle protruding beyond the tapered tip.

12. 1. A cartridge for use in skin abrasion for tattoo application and removal and other skin treatments, comprising: a housing having a proximal end, a distal end, and a cavity; a plurality of needles, each needle having a sharp distal end and a blunt proximal end; a stem having a distal end and a proximal end, the stem further comprising a central pin extending distally from the stem; Equipped with the plurality of needles are arranged adjacent to one another in a circular pattern such that the plurality of needles form a ring surrounding the central pin. cartridge.

13. The cartridge of claim 12 , further comprising an elastomeric retainer that provides a biasing force in a direction to retract the plurality of needles into the housing.

14. The cartridge of claim 12 , wherein the stem comprises a drive rod that interfaces with a handpiece including a reciprocating drive.

15. The cartridge of claim 12 , wherein the plurality of needles includes nine needles.

16. The cartridge of claim 12 , wherein the plurality of needles comprises between 7 and 22 needles.

17. 1. A cartridge for use in skin abrasion for tattoo application and removal and other skin treatments, comprising: a housing having a proximal end, a distal end, and a cavity; a needle tube having a circular sidewall and a plurality of sharp tips formed at a distal end of the circular sidewall; a stem attached to and extending proximally from the tube needle; A cartridge comprising:

18. 18. The cartridge of claim 17, wherein the needle tube is attached to the stem by an adhesive.

19. 20. The cartridge of claim 17, wherein the needle tube further comprises a slot through which fluid flows during use of the cartridge for skin ablation.

20. 18. The cartridge of claim 17, further comprising a tapered tip formed adjacent a distal end of the cartridge, wherein at least a portion of the sharp distal end of the tubular needle protrudes beyond the tapered tip when the needle tube is in an extended position.

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