Templates and methods for tattoo removal by patterned epidermal pigment release
By using the patterned transepidermal pigment release (TEPR) method, tattoos are processed in stages using templates, optimizing wound size and shape. This solves the problems of multiple overlapping processes and scar formation in traditional TEPR methods, achieving efficient and low-scarring tattoo removal results.
Patent Information
- Application Number
- CN202080095691.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-12-09
- Filing Date
- 2020-12-08
- Publication Date
- 2025-11-04
- Estimated Expiration
- 2040-12-08
AI Technical Summary
Existing technologies are difficult, costly, and painful in removing tattoos, and are prone to leaving scars. In particular, the traditional TEPR method has design flaws that lead to multiple overlapping processes and scar formation.
The patterned transepidermal pigment release (TEPR) method is employed, which marks the skin treatment area with a template and delivers tattoo removal fluid in stages using primary and secondary templates. This optimizes wound size and shape, reduces overlapping areas, and uses templates to outline non-circular and non-polygonal aperture patterns. It also combines mechanical and chemical damage to remove epidermal cells.
It achieves effective tattoo removal with a minimum number of treatment stages, reduces skin sensitivity, inflammation, and scar formation, optimizes the tattoo removal process, and avoids the adverse effects of multiple overlapping treatments.
Smart Images

Figure CN115151297B_ABST
Abstract
Description
[0001] Cross-references to related applications
[0002] This application is a partial continuation of U.S. Patent Application No. 16 / 707,865, filed December 9, 2019, entitled “Method for Removing Tattoos by Patterned Transepidermal Pigment Release,” which is a partial continuation of U.S. Patent Application No. 15 / 261,670, filed September 9, 2016, entitled “Method for Removing Tattoos by Patterned Transepidermal Pigment Release,” and granted on December 10, 2019, as U.S. Patent No. 10,500,013 (which claims U.S. Provisional Patent Application Serial No. 62 / 216,206, filed September 9, 2015, entitled “Tattoo and Tattoo Removal Apparatus and Method”). The contents of each earlier application are incorporated herein by reference in their entirety. Background Technology
[0003] Tattooing is a process that introduces colored ink into the dermis of the skin to permanently color it. This process involves repeatedly piercing the epidermis with a needle coated in ink, thus applying the colored ink in a controlled manner to the dermis. Once pierced, the skin cells rub off the ink from the needle, essentially staining the cells with the desired pigment.
[0004] Over time, tattoos (and permanent cosmetics) can become less desirable due to poor design, social stigma, or life changes (such as changes in career or relationships). Tattoo removal can be difficult, costly, and painful. Improvements are needed in tattoo removal to better serve the majority of clients and reduce the difficulty, cost, and pain of the removal process. Summary of the Invention
[0005] The subject of this application is developed in response to the current state of technology, particularly addressing the shortcomings of tattoo removal that have not yet been fully resolved by currently available technologies. The subject of this application has been developed to overcome at least some of the shortcomings of existing technologies.
[0006] Embodiments of methods of tattoo removal by patterned trans-epidermal pigment release are described. In one embodiment, a method of tattoo removal by patterned trans-epidermal pigment release includes determining a first treatment area of a patient's skin by a primary template including primary apertures; marking the first treatment area of the patient's skin along the boundaries of the primary apertures to outline a grid of primary pellicles; and delivering a tattoo removal fluid to the marked first exposed skin in a first treatment session. The method further includes determining a secondary treatment area by a secondary template including secondary apertures; marking the secondary treatment area along the boundaries of the secondary apertures to outline a grid of secondary pellicles; and delivering the tattoo removal fluid to the secondary pellicles in a second treatment session. Other embodiments of methods of tattoo removal by patterned trans-epidermal pigment release are described.
[0007] Other aspects and advantages of embodiments of the present application will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, illustrated by way of example of the principles of the application.
[0008] The described features, structures, advantages, and / or characteristics of the subject disclosure can be combined in any suitable manner in one or more embodiments and / or implementations. In subsequent descriptions, numerous specific details are provided to give a thorough understanding of embodiments of the subject disclosure. One skilled in the relevant art will recognize, however, that the subject disclosure can be practiced without one or more of the specific details, or with additional components, materials, and / or methods. In other instances, additional features and advantages will be recognized in conjunction with the descriptions that follow and the accompanying figures. Further, it will be recognized that some embodiments and / or implementations disclosed in this detailed description can not include, or can inherently BRIEF DESCRIPTION OF DRAWINGS
[0009] In order that the advantages of the subject matter will be 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 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 by reference to the accompanying drawings, of which:
[0010] Figure 1 Templates including a square pattern of circular apertures and an overlapping diamond pattern of circular apertures are depicted in accordance with one or more embodiments of the present disclosure.
[0011] Figure 2 Treatment patterns resulting from three treatments with an optimized placement template utilizing a diamond pattern of circular apertures are depicted in accordance with one or more embodiments of the present disclosure.
[0012] Figure 3 A graphical representation of the diameter to pitch ratio depicting the amount of uncovered skin area and the amount of overlapping skin versus the diameter to pitch ratio of the template apertures is depicted in accordance with one or more embodiments of the present disclosure.
[0013] Figure 4 A template having a diamond pattern of circular apertures and a row of elongated apertures is depicted in accordance with one or more embodiments of the present disclosure.
[0014] Figure 5 A template having a diamond pattern of non-circular and non-polygonal apertures is depicted in accordance with one or more embodiments of the present disclosure.
[0015] Figure 6 A treatment pattern resulting from a first pass utilizing a primary template having a diamond pattern of circular apertures and a second pass using a secondary template having a diamond pattern of non-circular and non-polygonal apertures is depicted in accordance with one or more embodiments of the present disclosure.
[0016] Figure 7 A template having a square pattern of octagonal apertures in accordance with one or more embodiments of the present disclosure is depicted in accordance with one or more embodiments of the present disclosure.
[0017] Figure 8 A treatment pattern resulting from a square pattern of octagonal apertures is depicted in accordance with one or more embodiments of the present disclosure.
[0018] Figure 9 A template having a diamond pattern of octagonal apertures is depicted in accordance with one or more embodiments of the present disclosure.
[0019] Figure 10 A point connect treatment pattern having square tegulae is depicted in accordance with one or more embodiments of the present disclosure.
[0020] Figure 11 A point connect treatment pattern having triangular tegulae is depicted in accordance with one or more embodiments of the present disclosure.
[0021] Figure 12 A template having a diamond pattern of circular apertures is depicted in accordance with one or more embodiments of the present disclosure.
[0022] Figure 13 A template of Figure 12 is depicted in a side view with a release liner peeled away in accordance with one or more embodiments.
[0023] Figure 14 A top view of a circular template is depicted in accordance with one or more embodiments.
[0024] Figure 15 A top view of an elliptical stencil is depicted in accordance with one or more embodiments.
[0025] Figure 16 A top view of a stencil with a circular aperture is depicted in accordance with one or more embodiments.
[0026] Figure 17 A top view of a stencil with multiple large pin apertures is depicted in accordance with one or more embodiments.
[0027] Figure 18 A top view of a primary stencil with primary apertures is depicted.
[0028] Figure 19 A top view of a secondary stencil with secondary apertures is depicted.
[0029] Figure 20 Primary and secondary apertures of primary and secondary stencils are depicted.
[0030] Figure 21 A top view of an asymmetric stencil with apertures is depicted.
[0031] Figure 22 A top view of a symmetric stencil with apertures is depicted.
[0032] Figure 23 A top view of a first three-stencil with multiple stencils is depicted.
[0033] Figure 24 A top view of a second three-stencil with multiple stencils is depicted.
[0034] It is to be understood that the figures are illustrative only and the present disclosure should not be limited by the illustrations in the figures. The embodiments shown achieve the various aspects and objects of the present disclosure. It is understood that not every element and aspect of the present disclosure can be shown in a single figure and, therefore, multiple figures are presented to more particularly point out various details of the present disclosure. Similarly, not every embodiment need implement every advantage that can be achieved by the present disclosure.
[0035] While the present disclosure is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the disclosure is not intended to be limited to the particular forms disclosed. Rather, the disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the appended claims.
[0036] Throughout the description similar reference characters can be used to identify like elements. DETAILED DESCRIPTION
[0037] It is readily understood that the components of the embodiments, as generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the 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 the figures, the figures are not necessarily drawn to scale unless specifically indicated.
[0038] The application can take other forms, all without departing from its spirit or essential characteristic. The described embodiments are to be considered in all respects only as illustrative and not restrictive. Therefore, the scope of the application is indicated by the appended claims rather than by the description of the embodiments. All changes that come within the meaning of and equivalency of the claims are intended to be embraced therein.
[0039] Reference throughout this specification to features, advantages, or similar language does not mean that all of the features and advantages that can be achieved with the present application should be or are in any single embodiment of the application. 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 application. Thus, discussions of features and advantages, and similar language, throughout the specification may, but do not necessarily, refer to the same embodiment.
[0040] Furthermore, the described features, advantages, and characteristics of the application can 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 application can be practiced without combining one or more of the
[0041] Reference throughout this specification to "an embodiment," "one embodiment," or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the application. Accordingly, appearances of 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.
[0042] While many embodiments are described herein, at least some of the described embodiments allow for effective removal of tattoos, permanent cosmetics, and other non-erasable markings or pigments on and under the skin. Some embodiments minimize reprocessing overlap of tattooed skin. Some embodiments allow for effective isolation of the tattooed skin patch (envelope) for the final removal process. Some embodiments provide for front-loaded removal of tattoos in the first pass. Some embodiments reduce the total number of processing stages. Some embodiments reduce the likelihood of scarring. Some embodiments are not affected by skin movement and skin stretching.
[0043] While the description herein is primarily directed to tattoo removal, the devices, systems, and methods described herein can also be used for tattooing or other ink applications to a patient's skin, among others.
[0044] Trans-epidermal pigment release (TEPR) is a non-laser process for removing tattoo ink that employs a localized depth skin injury to initiate a beneficial healing response. These are superficial injuries that penetrate but do not pass through the dermis. The beneficial response is the formation of a focal or crusted scab of the necrotic skin tissue. The tattoo ink is extruded from below the skin by the healing and regenerating epidermis and dermis.
[0045] U.S. Patent No. 8,663,162 (Tattoo Removal System, Patent No. 162) describes a system that delivers a focal scab inducing material (EIM) via a pump to a handpiece with reciprocating needles, similar to those used in tattoo machines. The combined mechanical injury (via the penetrating needles) and chemical injury (via the EIM) removes all epidermal cells, destroys the epidermal structure to a specified depth, and effectively initiates focal scab formation. Subsequent healing completely removes the tattoo ink (regardless of color and composition) from the injured site.
[0046] TEPR is most effective when the injury is confined to the area of skin that interfaces with the non-injured skin. The embodiments described herein utilize a template to outline the treatment area of the skin and limit it to a specific size and shape that balances the need for sufficient area to apply the TEPR process with the need to interface with non-injured skin.
[0047] Keratinocytes are the cells responsible for the cellular epidermal structure and barrier function. A fresh wound (lacking a protective epidermis) is quickly covered by proliferating keratinocytes that diffuse (under a temporary scab) from the non-necrotic interfacing tissue. The interfacing non-injured skin is important to the healing process.
[0048] When a thin layer of keratinocytes completely covers the wound, the wound becomes fully epithelialized. This typically occurs within 2 to 3 weeks after injury. After epithelialization is complete, the stratification of keratinocytes (seen in the mature epidermis) is reestablished, while other cells in the dermis reestablish the underlying dermal matrix structure. Epidermal maturation takes months to complete, such as 8 to 12 weeks. The underlying dermal matrix is rapidly reestablished with oriented fibers (a characteristic of tough scar tissue) that are subsequently remodeled over many years into more pliable tissue. During skin reestablishment, depending on the depth of the wound, genetic predisposition, and post-care (such as attempts to control trans-epidermal water loss and skin stress), visible and hypertrophic (raised) scars can form.
[0049] Keratinocytes proliferate to cover fresh wounds at a rate determined by the natural growth and cell cycle time to control mitosis (asexual cell division). Thus, when the minimum linear or area extent of a wound is large, epithelialization is delayed. This leads to fibrosis, hypertrophic scarring, and poor healing. The goal of TEPR is to create a wound in a spatial pattern that favors healing and eschar formation. When the wound is too small, the ink coagulum will be limited or will not form. When the wound is too large, the skin will be damaged and scarring will occur. The embodiments described herein utilize a template (see, e.g., FIGS. 1-3) to mark the potential treatment area to optimize the size and shape of the wound. Figure 4 , Figure 5 and Figure 7 ) to mark the potential treatment area to optimize the size and shape of the wound.
[0050] Unlike laser treatment, TEPR removes all tattoo ink at the treatment site in a single session. Since TEPR treatment always occurs locally at abutting sites that do not touch the skin, the tattoo must be removed bit by bit. With a series of treatment sessions, each separated by an inter-session healing period (lasting approximately 8 to 12 weeks), the tattoo is removed completely in an entire area where the entire or a substantial portion of the skin is tattooed. Modern multi-color tattoos are typically full-area tattoos.
[0051] Embodiments of the advanced TEPR series achieve various goals of optimizing treatment during tattoo removal. Embodiments minimize overlapping re-treatment areas to minimize the potential for skin sensitization, inflammatory reactions, and visible scarring. Embodiments effectively cope with the vagaries of manual treatment by, for example, automatically compensating for skin motion and stretching. Finally, embodiments allow the removal process to be completed in a minimum number of treatment sessions.
[0052] Embodiments of the advanced TEPR process achieve some or all of these goals simultaneously. The basic idea is to divide the tattoo surface into skin patches to completely cover the skin with minimal overlap and to remove uniformly spaced skin patches (tegulae) in a series of treatment sessions. To achieve this, only disc-shaped treatment sites (as disclosed in U.S. Patent No. 6,162,117) cannot be used for all treatment sessions. The treatment sites of a skin patch can be called tegulae (singular tegula and adjective tegular). The name is etymologically derived from the literal meaning of "skin patch" from the ancient Roman tegulae (singular tegula) and tegularia (adjective tegular) roof patch systems and the skin as a tegula of the body.
[0053] Compared to some methods with overlapping processing locations, embodiments of the advanced TEPR process decompose the surface into a theoretically defined film that completely covers the surface without overlap. Some films in a series may be circular, but not all. Films can be circular, square, hexagonal, triangular, polygonal, arbitrary shapes, curved, or a combination of polygonal and curved shapes. A complete patch series may contain only one type of film (e.g., see...). Figure 10 and Figure 11 ) or many different shapes and sizes of membranes 600 (e.g., see Figure 6 () combination.
[0054] In each stage of a series, some membranes are treated, while others remain intact. For any given stage, the treated or “excised” membranes are called excised membranes (extegs), while the intact or “whole” membranes are called whole membranes (integs). A membrane that is an excised membrane in one stage is a whole membrane in another stage, and vice versa.
[0055] To prevent the leaving of adjacent ink halos, in some embodiments, the practical excision film may be slightly larger than its theoretical counterpart; in other words, the practical excision film is minimal overlap.
[0056] Taking into account the shortcomings of traditional pattern processing methods, Figure 1 A stencil 100 is depicted, comprising a square pattern 102 (indicated by shading from the upper right to the lower left) with a circular aperture 104 and an overlapping diamond pattern 106 (indicated by shading from the upper left to the lower right) with a circular aperture 120. Patent No. 162 describes a stencil for applying TEPR patterns to tattooed skin. Figure 8 (as well as claims 1, 7, and 8). The TEPR treatment site (referred to as a "dot" in patent 162) is a disc-shaped area on the skin marked by template holes called apertures. The diameter (d) of the circular aperture can be between 3 and 6 mm, preferably 5 mm. The spacing (h) between the template apertures can be between 2 and 5 mm, preferably 3 mm. Figure 1 It depicts the scale in millimeters on the X and y axes.
[0057] Patent No. 162 does not specify any particular pattern or aperture arrangement, but only describes a template with "constant diameter and "uniformly spaced circular apertures". This description allows for a continuum of conventional templates. All circular apertures are placed at the intersections of grid lines, or equivalently, at the vertices of the rhomboid cells defining the grid (see, for example, [link to patent 162]). Figure 1 The rhombus cell has the shape of a general rhombus or an equilateral parallelogram. Equilateral cells ensure uniform aperture spacing.
[0058] In the case of an aperture arrangement in a square grid, the generalized rhombic cell becomes a square (side length s - d - h). When the apertures of adjacent rows are shifted horizontally, the square cell becomes a rhomboid or diamond (see, for example, Figure 4 ). This shift reduces the row spacing, making the arrangement compact, and advantageously increases the ratio of aperture to cell area. Since each rhombic cell contains exactly one quartered aperture, this area ratio is exactly the fractional coverage of one pattern application. For the same aperture diameter and spacing, a more compact arrangement will yield a greater fractional coverage, which means that more tattoo can be removed in a single treatment session.
[0059] The least compact regular arrangement is the square grid. The most compact arrangement is the case of shifted rows, such that the grid points lie exactly between the grid points of adjacent rows (see, for example, Figure 4 ). This yields a rhombic cell composed of two equilateral triangles, which defines the grid. It is sometimes called a hexagonal lattice, so named because each grid point is equidistant from six adjacent grid points.
[0060] 162 patent Figure 8 shows a stencil with circular apertures on a hexagonal lattice. Other figures (such as the 162 patent Figures 9-11 ) show how this diamond pattern can be shifted and reapplied to completely cover the area in a series of three treatment sessions (see also, for example, the present application Figure 2 , which shows a primary film 202 for a first treatment session, a secondary film 204 for a second treatment session, and a tertiary film 206 for a third treatment session). Figure 2 Further depicted are scales in millimeters on the x and y axes.
[0061] A series of similar treatment sessions is required to completely cover the area of a square grid pattern, but in this case, four treatment sessions are required. The treatment sessions in a series can be named sequentially: primary, secondary, tertiary, quaternary, quinary, etc.
[0062] Although not explicitly stated, the 162 patent disclosure also implies a square grid pattern, in which a series of four treatment sessions is required to consider complete removal: (162, lines 2-19) "Approximately, four such treatments are usually required, then (162, lines 2-37) "Depending on the size of the tattoo, the average number of treatments is at least 4 to 8. Since large tattoos are usually divided into two treatment areas, the latter means four treatment sessions per treatment area, as required by a square grid pattern.
[0063] Years of experience with classic pattern designs (i.e., a 5 mm diameter disc centered on a hexagonal lattice point with 8 mm spacing) have shown that the stencil is necessary and effective in providing the proper pattern spacing. Additionally, when the stencil is not used during the primary treatment, subsequent stages in the removal series are technically more difficult. In addition to the three overlay stages required for the hexagonal lattice pattern, an additional one to three stages are required to completely remove the remnants of a full area tattoo. As a result, the skin stretch, subsequent pattern application can be distorted relative to those laid out in the early stages of treatment.
[0064] However, even if the skin is not stretched and the theoretical pattern is applied perfectly each time, several additional treatment stages are required due to design flaws that the inventors have not recognized. Patent 162 requires a series of treatments to transfer the same pattern to the untreated skin that is covered by the previous treatment. However, even when this is done perfectly, the preferred design leaves uncovered defects 208 (see, for example, Figure 2 ), where the skin has not been treated with TEPR and where the tattoo has not been removed even after three treatment stages. To remove these undiscovered defects 208, several of these additional treatment stages are required.
[0065] These triangular tattoo remnants (e.g., 208) are small, but numerous. For the diamond pattern, there are six times as many defects as there are pattern apertures. Since these defects are uniformly distributed, multiple treatments are required to remove them.
[0066] When the treatment disc is too small, eschar formation and pigment release can be inhibited. Therefore, the strategy for removing small defects is to combine them together. However, since they are uniformly distributed, only two defects fit within a standard 5 mm treatment disc. Therefore, these six defects (per pattern aperture) can require three additional treatments to completely remove the tattoo remnants. This doubles the total number of treatments required. These three additional treatment methods are also technically more difficult than the original three because the same skin patch must be treated again.
[0067] Human skin never regenerates its original state. As a wound heals, scar tissue naturally forms. Tattoos and tattoo removal generate scar tissue, and when the scar tissue is prominent or hypertrophic, visible scarring occurs. One of the great advantages of TEPR treatment compared to laser removal is that the tattooed skin is treated only once. (The average laser removal - one treatment followed by nine re-treatments - severely damages the supple dermal structure.) Additional TEPR re-treatments diminish this advantage. Furthermore, the skin is sensitive to TEPR treatment and the EIM used. As a result, the regressive skin reaction is stronger and more scar tissue is generated. In a perfect TEPR process, re-treatment is avoided.
[0068] To better understand the nature of the design flaw, the theoretically uncovered 306 and overlapping 308 functions for the aperture diameter-spacing ratio (d / s) 302 are plotted (e.g., see...). Figure 3 This is useful. Uncovered 306 is the area fraction of skin left untreated after a complete TEPR series is completed (304). For a diamond pattern with round apertures, the entire series includes 3 processing stages. For a square grid pattern, a complete series includes 4 processing stages. Overlap 308 is the skin area fraction of skin that has been reprocessed multiple times (304). The best strategy for effective tattoo removal is to minimize overlap 308 while zeroing out the uncovered areas.
[0069] Figure 3 The results show that for all diamond patterns with circular apertures, the uncovered area 306 cannot be zeroed without causing significant overlap 308. The uncovered area 306 and overlap 308 functions are similar for all square patterns, but worse: more overlap is required to zero out the uncovered area.
[0070] The diameter-to-spacing ratio (d / s) 302 is a key parameter determining the coverage 306 and overlap 308 of a particular pattern's processing series. For a diamond pattern with a circular aperture, the lack of coverage only reaches zero when d / s is -2 / 3. This was not recognized in Patent No. 162, which did not even mention the possibility of discovering defects.
[0071] Template No. 162 (No. 162) Figure 8 ) and processing series fragments (No. 162) Figure 9 , Figure 10 and Figure 11 The drawing is not to scale. As shown, the stencil diameter to spacing ratio is close to half (d / ss 0.5), which is significantly smaller than the preferred design (column 8, rows 27-30, number 162), where d / s = 5 / 8. In contrast, the processing series fragment used to demonstrate full coverage (d / ss 0.7) exceeds the preferred design.
[0072] Given the design range of 3sds6 and 2shs5 mm provided by the patent (claim 1 of No. 162), a circular aperture diamond pattern with a 6 mm aperture and a spacing of less than 3 mm can meet the criterion of zeroing out of coverage, but this was not recognized by patent No. 162.
[0073] The minimum requirement for any useful TEPR series is complete coverage of the tattooed skin. (This assumes the most difficult scenario: removing an entire area of tattoo. Obviously, this requirement can be relaxed when removing partial areas of tattoo, or when selectively modifying a tattoo to prepare for coverage.)
[0074] In an embodiment of the advanced TEPR process, refer to Figures 4-6The first processing stage may include the use of a diamond pattern with a circular aperture 402 (see, for example, see...). Figure 6 Template 400 (608). The second processing stage may include using template 500 with a diamond pattern having non-circular and non-polygonal apertures 502. The array of non-circular and non-polygonal apertures 502 will be aligned with the circular aperture 402, as... Figure 5 As shown in the dashed circle 504. The third processing stage removes the residual isolation film from the residual tattoo ink markings. The template 400 may be a sheet of material having a plurality of apertures spaced apart in a repeating pattern. In some embodiments, the sheet of material is configured to be flexible to conform to the patient's non-flat skin surface. In some embodiments, the sheet of material is configured to be flexible without stretching. That is, the distance between the apertures is not increased by stretching in the lateral direction between the apertures.
[0075] In one embodiment, the circular apertures 402 are disks with a diameter of 5 mm and a spacing of 8 mm. The circular apertures 402, when combined, cover approximately 35% of the cell (composed of...). Figure 6 (Represented by rhombus 608 in the diagram). The remaining 65% is uniformly distributed between the secondary coating 604 and the tertiary coating 606. These excised coatings are triangular partitions of a hexagonal lattice, minus the main disk. That is, the secondary coating 604 (i.e., the processed region of the second processing stage) and the tertiary coating 606 (i.e., the processed region of the third processing stage) are a combination of polygons (triangles) and curved shapes (circular excised segments). The triangles are formed by vertices at the center of the circular aperture, and the corners of the triangles are removed as part of the circular aperture. The resulting shape is... Figure 5 The non-circular and non-polygonal aperture 502 is shown.
[0076] How the excised capsule is removed is the difference between overlapping and advanced TEPR procedures. The primary treatment is the same for both: a template 400 is used to define the first or primary treatment area of the skin. The template 400 and aperture 402 guide a skin marking pen as the patient's exposed skin (through the template 400) is marked along the boundary of the circular aperture 402. The skin can be marked in any way using any of many devices, including, for example, spraying ink from a spray gun, which can be driven by canned air or an externally pressurized air system. A handheld device (or a drive unit and syringe) (supplying a controlled flow of EIM) is then used to scribble each mark of the primary capsule (e.g., see...). Figure 6 (602 in the middle). The process involves adding gray lines to the circular primary capsule 602. The skin is then cleaned to remove all markings except for the gray-lined primary capsule 602. Each primary capsule 602 is then excised using the handpiece, removing all epidermal cells until the densely stained reticular dermis is uncovered. The excision also sharpens and defines the capsule boundaries and mechanically and chemically disrupts the internal structure of the dermis.
[0077] In advanced TEPR procedures, the secondary and tertiary treatments differ significantly from the primary treatment, especially during the critical excision process. The secondary envelope 604 is marked with a template 500 as shown. The dotted circles in the template 500 (represented by dotted circles 504) are aligned with the primary envelope 602, which now (after the healing process) stands out as the healed fresh skin, polka dotting the inked tattoo. The template 500 can be readjusted as necessary so that the broken circles are always aligned near the marked primary envelope 602. Figure 5
[0078] The scoring is done in a similar manner as described above. After the skin is cleaned, the excision proceeds as normal, except that the sharpened excision envelope boundaries are defined. These boundaries are defined as the primary envelope disks (healed polka dots) and the theoretical line connecting their centers. Although not marked, the boundaries are easily visualized as the mental construct connecting the healed polka dots. Care can be taken to TEPR all the inked skin within these boundaries. It is this important procedural difference that eliminates all un-discovered defects (see, e.g., Fig. 208 of Figure 2
[0079] In fact, the healed primary envelope 602 serves as a permanent alignment marker, directly defining the excision envelope pattern of the secondary envelope 604. Even so, the secondary envelope 604 is not easily recognized and marked without the secondary template 500. Attempting to mark them by eye (without guidance) would result in the entire envelope (i.e., the tertiary envelope 606) being marked as the excision envelope in the second treatment phase. Each mistake would place two excision envelopes together, which would result in the removal of the adjoining tertiary envelope 606 and secondary envelope 604. The size can prevent its removal. Such mistakes can result in additional re-treatment phases.
[0080] After the first and second treatments, all the residual tattoo ink is sequestered within the tertiary envelope 606. The tertiary treatment does not require any template, as the tertiary envelope 606 is the sequestered ink. One simply treats the residual ink. That is, the now-healed primary envelope 602 and now-healed secondary envelope 604 form the sequestered ink pattern (i.e., the tertiary envelope 606). Figure 6 The grids depicted are: the primary membrane 602 (i.e., the grid of the right-shaded circle), the secondary membrane 604 (i.e., the grid of the left-shaded non-circular and non-polygonal shape), and the third membrane 606 (i.e., the grid of the non-circular and non-polygonal shape without shading). As shown, each of the primary membranes 602 is adjacent to three secondary membranes 604 and three tertiary membranes 606, each of the secondary membranes 604 is adjacent to three primary membranes 602 and three tertiary membranes 606, and each of the last tertiary membranes 606 is adjacent to three primary membranes 602 and three secondary membranes 604. The secondary membranes 604 and tertiary membranes 606 have the same shape. Figure 6 The described process means that tattoo removal only requires three treatment stages.
[0081] Because TEPR treats the skin in areas where it meets intact skin, there are fundamental constraints limiting the possible patterns and series used in tattoo removal. All TEPR patch series can be categorized into skin bridge series (see, for example...). Figure 6 Skin Island series (see example) Figure 8 and Figure 9 ) or point connection series (see, for example, 10 and Figure 11 There are no other possibilities besides the horizontal and nested combinations of these three.
[0082] In the skin bridge series, the excised caps (i.e., the caps corresponding to a specific treatment stage) are disconnected from each other and isolated by a closed network of monolithic caps (the other two caps do not correspond to a specific treatment stage). The monolithic caps form untreated skin bridges that surround and isolate the excised caps from each other. For example, the second caps 604 and the third caps 606 together form an untreated skin bridge (around the first caps 602) during the first treatment stage. The first caps 602 and the third caps 606 together form an untreated skin bridge (around the second caps 604) during the second treatment stage. Finally, the primary caps 602 and the secondary caps 604 together form an untreated skin bridge (around the third caps 606) during the third treatment stage.
[0083] Figure 6 A useful series of skin bridge patches is shown. (Although not a series of patches, it is defined by U.S. Patent No. 162 and is by [unclear - likely a patent name].) Figure 1 The classic overlapping pattern shown also forms the Skin Bridge series. ) The minimum number of processing stages required to complete the Skin Bridge tile series is three stages.
[0084] For skin bridging series, one exception to this rule involves removal areas where a single membrane can be stretched to span the entire width of the area. In this case, the removal area can be treated twice using a striped patch pattern.
[0085] The striped skin bridge series is a subset of the skin bridge series process. The striped pattern (where the contoured film spans the entire removal area) can be applied to elongated areas in two stages. The template used to lay out the primary pattern is a series of rectangular or elongated elliptical slots in a linear pattern (see example...). Figure 4 (404) slender aperture in the middle. Figure 4 The scale on the X and Y axes, measured in millimeters, is further depicted.
[0086] Striped patterns are particularly advantageous when dealing with lines. In this case, the film is narrowed and elongated (while the film area remains constant) to effectively cover a narrow line in two treatments. The resulting linearly elongated striped pattern is called a linear pattern. Two or more linear templates with elongated apertures of 404 can be used to lay out striped patterns along straight lines and / or curves. An example is shown as follows. Figure 4 The bottom row of the template shown.
[0087] A particular advantage of using striped patterns to cover large areas is that the stripes can be aligned with the natural structure of the underlying dermis. Directional incisions are commonly used in plastic surgery to promote healing and reduce scarring. Stripe orientation (a flowing pattern parallel to the Lange lines) can be used to promote healing and minimize scarring during tattoo removal.
[0088] In the skin island series, the excised capsule is connected into a lattice network, which isolates the overall capsule into a secondary capsule 804. Figure 8 and Figure 9 A useful series of skin island patches is illustrated. To better understand and alleviate dermal stress generated during healing, the excised capsule network is conceptually decorated with linear (or curved) straight lines and interconnected nodes. The skin island series is a type that is the opposite or negative of the skin bridge series. In both cases, whether it's a skin bridge or a skin island, the excised capsule is defined by intact skin. The skin island series is attractive because some can be completed in as few treatment stages as possible (i.e., two stages).
[0089] refer to Figure 7 A template 700 with a square pattern of octagonal aperture 702 is used as a negative template (instead of a positive template) because it directly marks the overall coating rather than removing the coating. The area that is primarily processed or removed (i.e., the primary lattice coating 802) is depicted as shaded and processed during the first processing stage, while the secondary coating 804 is retained as an overall coating.
[0090] The basic idea behind all skin island series is to isolate easily removable capsules (skin islands, see example) by completely surrounding the easily removable capsule with a lattice network (represented by shaded area 802) that forms the primary lattice capsule 802. Figure 8 Secondary membrane 804 orFigure 9 The secondary lattice film (904) and the primary lattice film (e.g., 802 and 902) should both be shaped so that they can be easily subjected to TEPR processing. Figure 8 and Figure 9 Both of the embodiments shown satisfy these basic requirements.
[0091] The Skin Island series is interesting because it removes tattoos completely with one less treatment than the best Skin Bridge series. Only two treatments are needed to complete the Skin Island series. Therefore, both the primary and secondary treatments should remove approximately equal areas of skin. The two series shown (…) Figure 8 and Figure 9 The cell areas 806 and 906 were evenly divided.
[0092] Primary lattice films (e.g., 802 and 902) conceptually consist of straight lines and interconnect nodes. Long linear TEPR cuts (e.g.) Figure 8 One problem (as shown) is the potential for long, linear scars. As the linear capsule heals, uniform cross-stress (contraction tension on the wound) is generated. In contrast, tighter wounds typically do not produce noticeable scars. Linear scars are avoided because the stress generated during healing is more isotropic.
[0093] A pair of techniques can be used to decompose the long linear region of cross stress. Figure 8 One approach is illustrated. Enlarged, nearly radially symmetric nodes generate near-isotropic stresses during healing. This breaks the transverse stresses in the extended straight path, thus reducing the likelihood of long linear scars. Figure 9 An additional technique is shown that offsets the straight path to decompose long linear features in one direction.
[0094] The lattice films (e.g., 802 and 902) are designed for ease of fabrication. Parallel lines are removed vertically to form a square grid. Next, the corner points of the overall film are trimmed to form enlarged nodes. Trimming is also valuable in making the octagonal overall film more rounded, thus making it easier to remove in the second processing stage.
[0095] Extended excision tracts can be marked using a template composed of parallel linear apertures, much like a template used to create a striped pattern. Mark one set, rotate the template a quarter turn, and then mark the second set. Alternatively, a negative template can be used to outline the pattern (see, for example, [link to relevant documentation]). Figure 7 In the sense that the entire membrane is marked at the boundary of the octagonal aperture 702 rather than the membrane is removed, this is a negative template.
[0096] The second treatment does not require a stencil because any remaining tattoo ink has been contained within easily removable octagons. The design is the ink itself.
[0097] One of the main achievements of the Advanced Tile Series is the minimization of the total number of treatment sessions required to completely remove a tattoo. This is important because the healing response of subsequent treatment sessions diminishes with each treatment. The pressure from clients to quickly remove unwanted tattoos often results in removal sessions scheduled during the shortest intermission healing period (typically 8 to 12 weeks). While the epidermis has been re-engineered, the skin is still maturing and remodeling and will continue to do so for months and even years. Therefore, subsequent treatments (especially overlapping patterns) inadvertently (or intentionally) re-treat newly healed skin, subsequently losing the healing response.
[0098] Because the first treatment always heals the best, more skin should be treated first. Therefore, the Advanced Series will purposefully reduce the fractional area treated at each session. The following table gives the possible removal sequences for the 3-Session and 2-Session Series. In each case, the total area treated exceeds the unit area due to the minimum overlap actually required.
[0099] All tile patterns (including the combination Figures 4-9 discussed patterns) can be adjusted to optimize the amount of skin treated in the first and subsequent sessions.
[0100] Patch Series Fraction of Area Removed Fraction of Overlap 3-Stage Series 0.50+0.35+0.25 0.10 2-Stage Series 0.60+0.45 0.05
[0101] In the Point Connection Series, the excision caps and the whole caps are mathematically point connected on common vertices (see, e.g., 1006 in Figure 10 and 1106 in Figure 11 ). The excision caps (e.g., the primary caps 1002, 1102 of the first treatment session) are not adjacent to other excision caps (i.e., they have no common boundary), and the whole caps (e.g., the secondary caps 1004, 1104 of the first treatment session) are not adjacent to other whole caps. Figure 10 and Figure 11 shows two point connected tile series that resemble a regular checkerboard with square caps 1000 (e.g., Figure 10 ) and triangular caps 1100 (e.g., Figure 11 ). In practice, the point connection series degenerates into a skin island series through erosion at the point connection vertices. If no vertex erosion occurs during excision, it will occur during healing.
[0102] Alternatively, the point connection series can be modified with additional vertex caps to prevent vertex erosion. The resulting pattern forms a useful skin bridge series.
[0103] Skin island series have the advantage that they completely remove a tattoo from an entire area with only two TEPR treatments. Point connection series are based on two treatment series square caps ( Figure 10) or a triangle latticework Figure 11 ) of the other. Both show the same lattice spacing (s = 5 mm).
[0104] While theoretically the point-connected latticework produces a new class of patches (different from the skin bridge and skin island series), in practice they always degenerate into the skin island series. This happens during excision or subsequent healing when the theoretical point connections at the latticework vertices 1006, 1106 are eroded and widened into straight lines. TEPR processing always necroses the adjoining epidermis to a fraction of a millimeter. Thus, the point connections, if they can be constructed at all, are only temporarily constructed from dying skin. The point-connected checkerboard excision latticework becomes a large node connecting a triangular mesh.
[0105] The three processing series can inhibit vertex corner erosion. The primary series places a round latticework at each theoretical point connection. The secondary and tertiary series then take out the ready and unready latticework. The result is the skin bridge series. In fact, Figure 6 The illustrated embodiment does just that. The point connection series does not easily sit between the skin bridge and skin island series, it either falls into the latter or can be pushed into the former.
[0106] For TEPR tattoo removal, the advanced TEPR process has significant advantages over the overlapping series (e.g., Figure 2 ). The advanced TEPR process covers comprehensively. Because they patch the surface, the patch series can completely cover the entire tattoo area without leaving the un-found defects inherent in the overlapping pattern. The advanced TEPR process minimizes reprocessing overlap, thereby minimizing inflammation and reducing the likelihood of visible scarring. The advanced TEPR process is not affected by skin movement and stretching. The primary healed latticework is used as a permanent marker to align and define intermediate processing (the secondary latticework in the skin bridge series). The advanced TEPR process uses templates for precise placement. The primary and intermediate processing patterns use templates to ensure accurate placement and alignment. The advanced TEPR process can isolate the final ink. The final processing in the series is technically easy because all residual ink is intentionally isolated in a properly sized and isolated excision latticework. No final template is needed. The ink is simply processed. The advanced TEPR process requires a minimum number of processing stages. Referring to Figures 4-6 , the skin bridge series embodiment requires only three processing stages. The striped skin bridge series and the skin island series (e.g., Figure 8 and Figure 9) only two stages. The advanced TEPR process reduces the likelihood of scarring. This is because the treatment overlap is minimized. By expanding the nodes and offsetting the straightaways, the likelihood of scarring from the excision of the network of the dermal islands can be reduced. The advanced TEPR process has areas that can be optimized. Because the first pass always heals the best, the removal series can be optimized by reducing the area of treatment for each successive stage. The advanced TEPR process typically employs a different removal pattern in each stage, which is suitable for the area optimization strategy. The advanced TEPR process is flexible. The advanced TEPR process is defined by a dermal mask that is tiled over an area and aligned to a lattice. The lattice can be deformed and resized to accommodate partial area tattoos and selective removal. The dermal mask is simply reshaped to completely cover the tattoo area to be removed.
[0107] So far, the discussion has been limited to TEPR series that remove full area tattoos, which are technically the most challenging. However, in the tattoo industry, removing tattoos entirely is far less important than modifying tattoos. It is particularly important to selectively remove unwanted tattoo elements in preparation for tattoo concealment.
[0108] In this regard, the progressive nature of tattoo removal using TEPR is highly advantageous. It uniquely provides tattoo artists with a new, valuable tool for selective erasure. While the tiled patterns are highly valuable in full area removal, they are particularly suitable for selective removal.
[0109] The embodiments described herein allow custom masks to be constructed and used. The process for selective removal using a custom mask is no more complex than full area removal. Although any advanced TEPR process can be used, the Figure 6 The embodiments described are hypothetical. For the first pass, the primary mask 400 is placed over the tattoo element selected for removal. Only the primary dermal mask 602 that falls within the selected area is marked. The circular dermal mask that lies outside and above the element boundary is not marked. The removal process is then performed on the first pass area. For the second pass, the second mask is aligned to the primary, healed skin, the dots. As before, the excision dermal mask that falls within the selected area is marked and TEPR processed. The boundary excision dermal mask is carefully excised to remove only the selected tattoo element to be removed. For the final pass, the ink residue within the selected tattoo element is directly removed. The ink is simply treated.
[0110] The advanced TEPR process associates a set of tiled dermal masks to each point in a two-dimensional lattice. So far, the lattices described have been regular, periodic repetitions of either diamond or square cells. For full area removal, a regular lattice is sufficient and useful. For selective removal, a non-regular lattice (without periodic constraints) is sometimes even more useful.
[0111] To customize the selection of removed tattoo area, the lattice can be stretched and continuously deformed, and certain parts can be removed entirely. The patch stencils are similarly deformed to cover the selected area without leaving gaps. While this can be accomplished with any patch series, it is particularly useful in conjunction with Figure 6 The described embodiments are particularly useful and easy to use.
[0112] The two-dimensional lattice is deformed or a set of points is uniformly distributed to cover the selected tattoo elements to be removed. The primary stencils are circular disks centered at these points. All the remaining stencils are triangulations of these points minus the primary disks. The lattice points are not placed on the boundaries of the selected area. Instead, the modified secondary and tertiary stencils define the boundaries. The only other constraint on the point locations is that each point must have an even number of nearest neighbors. A point with an odd number of nearest neighbors will produce two adjacent cutaway stencils. Such odd-neighbor problems are easily corrected with point addition or subtraction.
[0113] Once the points are located, a custom stencil is made for laying out the primary and secondary processing stencils (no tertiary stencil is needed because the remaining ink is isolated). The custom stencil can be cut with a computer-controlled cutter or it can be printed and applied as a temporary tattoo.
[0114] Because the custom stencil is computer-designed (then cut or printed), the tattoo geometry must first be entered. This data comes from a photograph of the tattoo. The required geometric transformations are accomplished by a raster.
[0115] One problem with using photographs and computer design for selective tattoo removal patch patterns and associated stencils involves the conversion between the curved surface of the body part and the planar representation of the image and stencils. Mapping an image from a generalized curved surface (such as a sphere) to a flat sheet is a classic problem with no perfect solution: no matter what mapping is used, the image will inevitably be distorted.
[0116] Fortunately, the vast majority of tattoos are placed on body surfaces that are curved in only one direction, like the surface of a cone. Such surfaces (with zero Gaussian curvature everywhere) are said to be intrinsically flat, which means that they can be unfolded onto a plane without distortion. For example, a sheet of paper can be (without distortion) rolled up into a cylinder or cone.
[0117] While a conical body surface is never perfectly flat (in the intrinsic sense), the skin and underlying muscle are flexible and stretchable. This makes it possible to apply a stencil and a paste tattoo locally, which are perfectly flat (in the intrinsic sense), without wrinkles or distortions in the appliance, which is relatively inextensible compared to the skin and muscle. When the appliance is pressed against the skin, the skin and muscle stretch so that the surface becomes essentially flat, like the appliance. In areas where this is not possible - over a depression or a bony protrusion - the necessary appliance wrinkles or folds.
[0118] In some embodiments, the stencil includes an adhesive surface to allow the stencil to be secured in place on the patient's skin. In some embodiments, a separate adhesive or tape can be used to secure the stencil in place for marking. In some embodiments, a tension band or strap is used to hold the stencil in place. Some embodiments can use spring clips, mechanical cages and rings, magnets, or any other mechanism to quickly, safely, and easily attach the stencil to the patient.
[0119] Since the applied stencil essentially flattens the underlying muscle, which would otherwise not be essentially flat, it is useless to know the surface geometry of the tattooed body part without stretching. Therefore, even if the geometry of the tattooed body part could be measured exactly (for example, by laser scanning), the result would be useless. Instead, the geometry of the tattooed body part must be measured after it has been essentially flattened by the inextensible appliance.
[0120] This measurement is achieved by a grating, which is transparent, relatively inextensible, and is an appliance that is overlaid with a grid of fine lines. The color of the grid lines is to highlight the tattoo they cover. The exact shape and size of the grid is irrelevant as long as it is well known (a one centimeter square grid is sufficient), and the grid itself can be replaced by a discrete dot or cross array or any other well-defined alignment pattern.
[0121] The grating is placed on the skin above the tattoo. If the tattoo is wrapped around a curved body surface, it is usually photographed from several angles. The grid locates points on the tattoo, which are used to mathematically unfold the essentially flattened tattoo from the body surface.
[0122] This unfolding transformation is not difficult. The grating positions are first located by image processing. Then the image is deformed until all grid positions (located in the image) return to their original positions in a very flat plane.
[0123] The externally flattened tattoo image (i.e. it is now lying on a plane) is then used in the custom template design process. Once completed, the direct cut or print template, without any further geometric transformation. When the generated template is applied to the tattoo, it will flatten the skin exactly as the original raster.
[0124] The custom template process can contain various steps, which include:
[0125] 1. Take a picture of the tattoo covered by the raster applied to the skin;
[0126] 2. Import the picture into the computer via a computer program;
[0127] 3. Image process the picture to find the raster alignment markers;
[0128] 4. Deform the image so that the raster alignment markers cover their original grid positions on a very flat surface. This deformation flattens the tattoo image (producing a deformed image);
[0129] 5. Display the flattened tattoo image so that the technician can outline the selected tattoo elements to be removed;
[0130] 6. Once the removal areas are defined, the computer program generates a custom patch series (and potentially a custom primary and secondary template);
[0131] 7. The primary and secondary templates are directly cut or printed by a computer-controlled commercial device;
[0132] 8. For the first treatment, the primary template is aligned with the selected tattoo elements and then the TEPR treatment is performed;
[0133] 9. For the second treatment, the secondary template is aligned with the primary, healed skin, polka dots. As described previously, the excision caps within the selected areas are marked and TEPR treated. The boundary excision caps are carefully excised to remove only the selected tattoo elements to be removed;
[0134] 10. For the final treatment, the ink residue within the selected tattoo elements is directly removed. The ink is simply treated.
[0135] Figures 1-2 and Figures 4-11 The x and y axes are depicted with a scale described in millimeters. Although drawn to scale, embodiments can contain varying sizes of apertures and varying distances between apertures not limited to the scale of the depicted and described figures herein.
[0136] Keratinocytes proliferate at a rate determined by the natural growth and cell cycle time that controls mitosis (non-gametocyte cell division) to cover fresh wounds. Thus, when the minimum linear or area extent of a wound is large, epithelialization is delayed. This can result in fibrosis, hypertrophic scarring, and poor healing. The goal of tissue disruption (including microparticulation) can be to create a wound in a spatial pattern that favors healing and light blood crusting. When the wound is too small, the disruption process can be ineffective. When the wound is too large, the skin can be damaged, and scarring can occur.
[0137] Reference Figures 12-13 In one embodiment, a template 1200 that can adhere to the skin is used to control the depth of the needle set, prevent lateral deviation of the needle set, and create a structured, patterned procedure to remove skin irregularities. For example, the skin irregularities that can be removed include skin damage, pigment damage, scars, acne, stretch marks, or any other skin irregularity. The skin irregularities can be removed by a micro- or macro-needling process. For example, puncturing the skin with micro-needles can cause the skin to produce new skin at its location.
[0138] Skin puncturing can involve a set of small needles or a single needle to puncture the epidermis and dermis at a predetermined depth. When the epidermis and dermis are punctured, the underlying cells, epidermal cells, and dermal fibroblasts are only minimally damaged, which produces a light immune response that initiates blood flow to the dermis. After the epidermis and dermis are punctured, immune cells (white blood cells) and transforming growth factor beta-3 are stimulated and are necessary in the production and regulation of new cell growth. In addition, the puncture channels created by the micro-needles or other puncturing devices stimulate fibroblasts to produce new collagen, giving the epidermis a smoother, fuller surface and better elasticity after the healing process. The depth and pattern of the needle set are important. The correct depth and puncture pattern of the needle set can effectively produce collagen and healing. Without the template 1200, the user is left to determine their own pattern of puncturing the epidermis and dermis, which can result in over-puncturing or under-puncturing of the skin area. The user can also puncture the skin too deeply, causing severe damage to the underlying cells and reducing the effectiveness of the treatment.
[0139] Accordingly, it can be advantageous to use a template with a thickness that helps the user control the depth of the needles, allowing the user to puncture the epidermis and dermis at a consistent depth. It should be noted that the depth of the needle set can also be adjusted on the needle device. The template 1200 includes a plurality of needle apertures 1202 for creating a structured procedure, an adhesive layer 1204, and a release liner 1206. The release liner 1206 can be removed, exposing the adhesive layer 1204, so that the template 1200 with the plurality of needle apertures 1202 can be positioned over a skin irregularity. The template 1200 can provide a structured method to remove many skin irregularities and tattoos found on the epidermis.
[0140] Template 1200 can be square; however, it should be understood that template 1200 can be many other shapes, such as circular Figure 14 ), rectangular, etc. Additionally, it should be understood that in one embodiment, the shape of template 1200 can be similar in shape and size to the skin irregularity to provide maximum control during the procedure. For example, as shown in FIG. 12B, an oval template can be used with a long skin irregularity on the epidermis so as to cover the entire skin irregularity without having too much template overlap on the non-irregular skin. Figure 15
[0141] Template 1200 can be a sheet of material 1208, which can be made of silicone, polypropylene, or any other material. In some embodiments, sheet of material 1208 can be flexible to conform to the non-flat skin surface of the patient. In some embodiments, sheet of material 1208 can be flexible while not stretching. That is, the distance between the plurality of needle apertures 1202 does not increase by lateral stretching between the plurality of needle apertures 1202. In some embodiments, template 1200 is a cut or missing portion of sheet of material 1208 to conform template 1200 to a skin irregularity or epidermal protrusion of any shape, such as a nose or chin.
[0142] The length, width, and height of template 1200 can vary. For example, there can be a 1 inch x 1 inch template, a 6 inch x 6 inch template, or any other size template. In one embodiment, template 1200 can be 4 / 3 inch x 1 inch, with needle apertures being 1.67 mm diameter discs that are 2.67 mm from the center of the aperture. Furthermore, the needle apertures can combine to cover approximately 35% of a unit cell, and the total number of needle apertures is 138.
[0143] The thickness of the template can help the user control the depth of the needles or needle set. In particular, needle apertures 1202 control the depth, as described below. Thus, controlling the depth of the needles helps the user perform different procedures and provides an optimal piercing depth, i.e., a depth at which cell damage is limited. This can improve the effectiveness of the destruction process and speed up healing of the dermal and epidermal layers. It should be noted that the depth of the needles or needle set can also be controlled by extending and retracting the needle set on the needle device, which can add more control and adjustability in piercing the epidermis and dermis.
[0144] In one embodiment, the thickness of the template can vary from side to side to account for variations in epidermal depth, particularly on the face. If a skin lesion covers both thin and thick epidermal areas of the face, the user can not be able to use the same depth of needle set due to the variation in epidermal thickness. For example, one side of the template can be thinner to provide a greater piercing depth on the thicker muscles above the mandible portion, while the opposite side can be thicker to provide a smaller piercing depth on the thinner muscles above the sphenoid or frontal bone.
[0145] Additionally, the stencil 1200 can include a plurality of needle apertures 1202. The plurality of needle apertures 1202 can be disc-shaped and spaced in a diamond pattern. The plurality of needle apertures 1202 can be small; however, they can also be large or any other size. Furthermore, as shown, the plurality of needle apertures 1202 can be uniformly distributed in a linear pattern across the stencil 1200. In some embodiments, the plurality of needle apertures 1202 can be other patterns and shapes, such as a circular pattern with square apertures or circular apertures. It should be noted that the pattern and shape of the needle apertures can be any pattern or shape to assist the user. Figure 16
[0146] Referring again to Figure 12 , the plurality of needle apertures 1202 can provide a location for a needle or needle set to enter the epidermis and dermis, for example, to remove a skin irregularity by simply piercing the epidermis and dermis, to stimulate collagen production, or to introduce a liquid via the pierced channel to remove a tattoo, such as a shallow tattoo in an eyebrow. The plurality of needle apertures 1202 can be large enough in diameter to allow a needle or needle set to enter, but small enough to prevent a needle cartridge tube from entering. This allows for a controlled procedure in which the user can insert a needle set to the same depth until the needle cartridge tube contacts the upper surface 1212 of the stencil 1200 in each of the plurality of needle apertures 1202. Additionally, in alternative embodiments, the plurality of needle apertures 1202 can be used to prevent damage to the epidermis. For example, each of the plurality of needle apertures 1202 can receive a needle cartridge tube, securing the needle cartridge tube and needle set in a single location and preventing lateral movement. This would prevent the needle set from laterally traversing the epidermis. Furthermore, the user would have to lift the needle set above the upper surface 1212 of the stencil 1200 to place it in another needle aperture, preventing the user from accidentally dragging the needle set across the epidermis. Conversely, without the stencil 1200, the user can drag the needle set or the needle set can shift while performing the piercing procedure, causing damage to the epidermis. It should be understood that the needle apertures 1202 can be various shapes, patterns, and sizes in order to receive a variety of gauges of needles and for a variety of skin irregularities or tattoos.
[0147] The adhesive layer 1204 on the lower surface 1210 of the material sheet 1208 Figure 13 ) to allow the template 1200 to be secured to the patient's skin. The adhesive layer 1204 can include any suitable adhesive. For example, the adhesive layer 1204 can be an acrylate, which includes a methacrylate and an epoxy diacrylate. Alternatively, the adhesive layer 1204 can be a silicone-based adhesive. The adhesive layer can coextend in a pattern or any other manner with the lower surface 1210 on the lower surface 1210 around the plurality of needle apertures 1202. In some embodiments, a separate adhesive or tape can be used to hold the template in place. In some embodiments, a tension band or strap is used to hold the template in place, or any other mechanism for quickly, safely, and easily attaching the template to the patient. Additionally, a release liner 1206 can be releasably adhered to the adhesive layer 1204. The release liner 1206 can protect the adhesive layer 1204 from being prematurely adhered to an undesirable location, and can be removed from the template 1200 before it is applied to the epidermis.
[0148] To use the template 1200, the user would remove the release liner 1206, exposing the adhesive layer 1204. The user would then apply the template 1200 over the skin irregularity of the patient. The user can then systematically place a needle set in each of the plurality of needle apertures 1202 to pierce the skin to a depth until the needle tube contacts the upper surface 1212 of the template 1202. Once all of the plurality of needle apertures 1202 or a portion of the plurality of needle apertures have been addressed, the user can remove the template 1200. This process can be performed multiple times. For example, after the first treatment, the user can move the template 1200 and repeat the same process, which can produce more collagen and remove the skin irregularity of the epidermis. In particular, in the second treatment, the user can move the template 1200 so that the plurality of needle apertures 1202 overlap the previously pierced skin channels. It should be noted that the second treatment can not need to be a full treatment. For example, the second treatment can only need the needle set to address half of the plurality of needle apertures 1202 or any other number. After the treatment, new collagen and epidermis can begin to replace the skin irregularity.
[0149] Reference Figure 17 In one embodiment, the large template 1300 includes a plurality of needle apertures 1302, where the plurality of needle apertures 1302 are large apertures 1304. The large apertures 1304 can accommodate macro-needles, large micro-needle sets, or other larger needles. In some cases, macro-needles can be used to increase collagen production in a large area of skin. Sometimes, larger needle apertures and larger templates can be used to stimulate collagen and elastin production to remove, for example, wrinkles. It should be noted that an increase in needle size also means an increase in the size of the conduit. When the conduit size is increased, it will be prevented from entering the needle aperture like a smaller conduit to control the depth of the needle set.
[0150] Trans-epidermal pigment release (TEPR) is a non-laser process for removing tattoo ink. TEPR can be achieved through a variety of different tissue damaging techniques. TEPR employs partial thickness skin lesions to initiate a beneficial healing response. These are superficial lesions that penetrate but do not pass through the dermis. The beneficial response is the formation of a focal or crumbly scab of necrotic skin tissue. The tattoo ink is extruded from the skin by the healing and regenerating epidermis and dermis from below.
[0151] TEPR is most effective when the lesion is confined to the area of skin that borders the undamaged skin. The embodiments described herein utilize a template to outline the treatment area of the skin and limit it to a specific size and shape that balances the need for sufficient area to apply the TEPR process with the need to spare the adjoining undamaged skin.
[0152] Keratinocytes are the cells responsible for the cellular structure and barrier function of the epidermis. A fresh wound (lacking a protective epidermis) is quickly covered by proliferating keratinocytes that diffuse from the adjoining non-necrotic tissue (under a temporary scab). The adjoining undamaged skin is important to the healing process. When a thin layer of keratinocytes is fully restored to the wound, the wound becomes fully epithelialized. This usually occurs within 2 to 3 weeks after injury. After epithelialization is complete, the stratification of keratinocytes (seen in the mature epidermis) is reestablished, while other cells in the dermis reestablish the underlying dermal matrix structure. Epidermal maturation takes months to complete, such as two to three months. The underlying dermal matrix is rapidly reestablished with oriented fibers (a characteristic of tough scar tissue) that are subsequently remodeled over years into more pliable tissue. During skin reestablishment, depending on the depth of the wound, genetic predisposition, and post-care (such as attempts to control trans-epidermal water loss and skin stress), visible and hypertrophic (raised) scars can form.
[0153] Keratinocytes proliferate to cover a fresh wound at a rate determined by the natural growth and cell cycle time that controls mitosis (non-gametocyte cell division). Thus, when the minimum linear or area extent of the wound is large, epithelialization is delayed. This can lead to fibrosis, hypertrophic scarring, and poor healing. The goal of TEPR is to create the wound in a spatial pattern that favors healing and scab formation. When the wound is too small, ink coagulum scabbing will be limited or not occur. When the wound is too large, the skin will be damaged and scarring will occur. The embodiments described herein utilize a template to mark the potential treatment area to optimize the size and shape of the wound.
[0154] Because TEPR treatment always occurs locally from the adjoining site that is not contacted by the skin, the tattoo must be removed little by little. Utilizing a series of treatment stages, each separated by an inter-stage healing period (lasting approximately 8 to 12 weeks), to completely remove the tattoo.
[0155] It should be appreciated that various tissue destructive techniques can be used to remove a tattoo or any skin irregularity. Accordingly, the following paragraphs discuss various tissue destructive techniques that can be used for patterned cauterization.
[0156] In some embodiments of patterned cauterization, mechanical methods can be used to destroy tissue. For example, a needle, abrasion, cutting, or any other mechanical method can be used to destroy tissue and promote tattoo removal and / or skin regeneration. In particular, tissue disruption affects a certain depth of pigmented dermis and overlying epidermis. Mechanical tissue disruption can be accomplished by dermabrasion, including burrs, brushes, or using other abrasive materials. Dermabrasion uses lateral motion to destroy tissue, which can eventually remove tissue. In some cases, depending on the way the substrate moves in the tissue, a needle can be used for dermabrasion. The response to mechanical skin disruption is the formation of necrotic skin tissue cauterization, promoting tattoo ink removal or skin irregularity removal. In particular, through TEPR, pigmented dermis is destroyed, but pigmented dermis is not removed. Thus, pigmented dermis is removed by the formation and expulsion of cauterization, which condenses pigmented ink and disrupted tissue.
[0157] In some embodiments, a thermal or cold probe can be used to destroy tissue by changing temperature. Accordingly, destroying tissue via temperature destroys pigmented tissue, promoting the formation of cauterization to remove ink. The temperature of the probe and the size of the probe can be used to control the depth of tissue disruption.
[0158] In addition, various chemical agents can be used to destroy tissue to induce cauterization. For example, acids can be used to necrotize cells and destroy the extracellular matrix, thereby inducing the body's healing process. The depth into the dermis that the chemical can access depends on the molecular properties of the chemical, the amount or concentration of the solution, and the way the chemical is dispensed (i.e., syringe mechanics). Biological methods can also destroy tissue. This can be achieved by controlling signaling molecules (such as peptides) or using organisms (such as bacteria) to break down cell walls. As with chemical techniques, biological methods can control depth by the amount of biological material, syringe mechanics, and signaling / organism properties. Thus, depending on the type of signaling or organism, the amount of biological material and the way it is introduced into the tissue will be determined.
[0159] Other tissue destructive techniques can include balanced ions and cold plasma ions. Balanced ions can destroy tissue via an electrically driven field (AC or DC), where depth is controlled by frequency and probe size. Similarly, cold plasma ions can destroy tissue by using an electrically driven field. Frequency, duty cycle, and probe size control depth, so adjustments can be made depending on the tattoo or skin irregularity.
[0160] In addition, focused waves and focused particles can destroy tissue to create a coagulum. In particular, focused waves use wave-like radiation such as ultrasound, light (e.g., incoherent light), laser light to destroy tissue. To control the depth of the focused wave into the tissue, the user can adjust the wave frequency and aperture that emits the focused wave. Many frequency ranges can be used, such as microwave, infrared, visible, or ultraviolet. On the other hand, focused particles use similar particle radiation, such as X-rays, gamma rays, alpha, protons, electrons, neutrons, etc. to destroy tissue. The depth of the focused particles in the tissue can be determined by the radiation type and emitter geometry.
[0161] Another tissue destruction technique utilizes directed radiation. The directed radiation includes visual and non-visual wavelength energy, which can be coherent or incoherent. It should be understood that specific wavelengths of visual and non-visual wavelength energy have been previously used for tattoo removal. The directed radiation can be delivered to the skin surface to be treated through a waveguide or directly impinging. When the directed radiation contacts the skin, the radiation destroys and necroses the inked skin tissue, inducing a healing response, causing the inked and dead tissue to coalesce into a coagulum. Thus, by remodeling the epidermis and dermis under the coagulum, the coagulum is pushed upward. The coagulum can form at the treatment site, such as the capsular site.
[0162] In some embodiments, tissue molecular bond breakage can occur via direct impingement. For example, direct impingement can destroy tissue by using high energy delivered with high repetition cycles, resulting in tissue rupture. Specific examples can include corneal tissue and high energy femtosecond laser pulses. Other methods of destroying tissue can involve burning the tissue to form a coagulum, as found in third degree burns with non-directed energy or accidental burns. It should be understood that many energy delivery ranges are acceptable for TEPR.
[0163] To deliver the directed radiation to the tissue, a pattern can be used. The pattern of energy delivery can be created by a scanning method involving a mechanical pattern generator, such as a galvanometer mounted on a mirror array to pattern the directed energy or light scatter in the pattern formation. When using light, the pattern can be controlled, allowing the scale or size of the treatment area to ensure that a healthy tissue bridge is maintained. In some embodiments, when using directed energy treatment, cooling the tissue surface prior to surface treatment can help ensure that the tissue bridge that needs to be maintained between the capsules is protected during the treatment cycle, and any heating, burning, or removal is limited to the treatment site.
[0164] Other patterns for delivering directed energy to the tissue can include a light capture method based on a scan of the area to be treated and placing that image into an image processing software program that determines the shape, size, time, depth, and frequency of treatment. In one embodiment, the pattern created by this type of programming can be scaled and manipulated by algorithms within the code to do more treatment on deeper pigmented areas and less treatment on lighter pigmented areas. Thus, less pigmented areas receive less energy than more pigmented areas. It should be understood that this method can help alleviate some of the pain associated with treatment parameters rather than treating the entire treatment site at one setting or one energy level. The algorithm can also take into account that some pigmented areas and tattoo colors absorb light more efficiently than others. Additionally, the algorithm can take into account the patient's skin pigmentation, which will promote the greatest tissue response with the least amount of energy delivery. It should be noted that any type of template, such as a physical template or a scan, can be used with the TEPR.
[0165] Another advantage of the above-described pattern is the smaller diameter of the treatment area. For example, in one embodiment, a smaller, more concentrated treatment area can provide high energy treatment to remove deep blue or black inks. Thus, smaller treatment areas and deeper treatment can be employed in selected areas of the entire tattoo. It should be noted that the film used on the treatment site can vary in diameter and depth from one location of the tattoo to another based on the treatment options calculated from the scan and the best. Thus, by varying the energy level used, deeper pigmented areas can be treated in the same amount of time as less pigmented areas. Overall, the pain can be more easily controlled because the pain is localized to small areas of the treatment site. Additionally, it should be understood that the TEPR is capable of removing inks independent of color or composition.
[0166] In one embodiment, the unique pattern developed by the algorithm for the custom treatment for tattoo removal can be positioned and registered on the patient and replicated at each treatment cycle of the treatment area according to the patient's natural features. In particular, the patient's moles, freckles, or other unique features can assist in the formation of the treatment area. Using these naturally occurring locations as registration markers, allows the pattern used for the initial treatment to be altered and evaluated each time to ensure that the tissue bridges are maintained, the treatment area is monitored to ensure ink removal as planned, and recovery as designed during treatment.
[0167] Additionally, in some embodiments, the epidermis of a patient can be treated by direct impingement, with a photo-reactive fluid or chemical sprayed or wiped on the surface prior to treatment, using the directed energy to enhance the uptake and destruction of the tissue. Patients with skin that does not readily absorb energy (i.e., light-skinned patients) can require a photo-reactive fluid. It should be noted that a photo-reactive fluid can help to increase the energy level at the surface of the epidermis, resulting in more rapid destruction or cauterization, reducing treatment and exposure time, and reducing the level of pain associated with longer treatment times and thermal loading.
[0168] Further, in some cases, a reflective template can be used in untreated areas to resist energy deposition in these areas. For example, a reflective template can be held in place during treatment, and can include an energy-reflective coating on the top surface. Thus, energy focused at a certain depth can be scanned over the reflective template and aperture to induce tissue disruption only within the aperture. Additionally, in some embodiments, an image can be projected onto the skin, where a user can place a fluid or medium on the skin that solidifies or colors when exposed to certain light wavelengths, creating a template on the skin.
[0169] While various examples of tissue-destroying techniques are discussed above, it should be understood that any other form of tissue disruption can be used in patterned escharization. Additionally, it should be noted that different tissue-destroying techniques can be used for different treatment patterns. As discussed herein with respect to various embodiments, a template provides an indication on the skin of a patient to define a treatment area composed of a capsule. Such a template can include any suitable method of providing indicia on the skin to define a capsule. Examples of potential templates include the physical templates discussed herein, including pre-fabricated templates and custom templates, as well as transparent templates, opaque templates, reflective templates, and the like. Alternatively, other templates can be used, including projected images that can be created through simulation and digital scanning. Further, a template can be generated digitally or virtually, and applied by creating a physical template, projecting a template, presenting the template to a practitioner in augmented reality, or programming an appropriate trajectory into a computer-controlled device, or any other method that would be understood by one of ordinary skill in the art to provide indicia of the size and shape of a capsule.
[0170] TEPRs can be used in a number of applications. One example involves the removal or modification of permanent cosmetic tattoos. In particular, permanent cosmetics used to define eyebrows can be removed or modified using TEPRs and overlay templates. As described below, various overlay templates can be used to mark a capsule of TEPRs of a tattooed eyebrow.
[0171] Reference Figure 18 In one embodiment, a system for removing a tattooed eyebrow 1400 includes a primary template 1402 having a primary aperture 1404. The primary template 1402 can be used to mark or lay out a first or primary TEPR treatment and a primary capsule. As discussed above, the primary template 1402 can be used to mark a first or primary TEPR treatment and a primary capsule.Figure 19 As shown, the secondary stencil 1406 includes secondary apertures 1408 for marking or laying out a second treatment and a second film. Thus, the primary film can be subjected to TEPR treatment during the primary treatment, and the secondary film can be subjected to TEPR treatment during the secondary treatment. Both the primary apertures 1404 and the secondary apertures 1408 include a striped pattern that can create an overlap of alternating primary apertures and secondary apertures. The striped pattern can remove the tattooed eyebrow in two treatments, while other patterns can require three treatments. However, in some embodiments, the primary apertures 1404 and the secondary apertures 1408 can include a circular or other type of pattern. It should be understood that in some embodiments, only the primary stencil 1402 is used in the TEPR treatment, as only two TEPR treatments can be needed to remove a full-area eyebrow tattoo with a striped pattern. Thus, after the first treatment, the second treatment is shown with residual ink as the target for TEPR removal.
[0172] In any series of TEPR treatments, the primary treatment always causes the least amount of skin damage. Thus, as much cleanup as possible should be performed during the primary treatment. This means that the width of the primary apertures 1404 is greater than the width of the secondary apertures 1408. Additionally, the primary apertures 1404 can be tapered to curve the striped pattern along the curved arc 1410 of the primary stencil 1402. Alternatively, in some embodiments, the primary apertures 1404 can not be tapered. The true perpendicularity falls in the middle of the gap between adjacent apertures. The near perpendicularity that defines the primary apertures 1404 lies a certain distance from the true perpendicularity of ±(gap / 2 + radius) / 2. This structure ensures that the gap between adjacent primary apertures is uniform, without any tapering.
[0173] Additionally, as Figure 19 shown, the secondary apertures 1408 on the secondary stencil 1406 fill the space between the primary apertures 1404 (see Figure 20 ). Thus, the secondary apertures 1404 can have the same uniform width (without any tapering), while the gap between adjacent apertures is tapered. It should be noted that since the width of the primary apertures 1404 is greater than the primary aperture-to-aperture gap 1412, the secondary stencil 1406 is the inverse. In other words, the width of the secondary aperture-to-aperture gap 1414 is greater than the secondary apertures 1408. The secondary apertures 1408 are positioned to cover the primary aperture-to-aperture gap 1412.
[0174] While the secondary inter-aperture gap 1414 is tapered, it can be made large enough so that the minimum secondary inter-aperture gap 1414 always exceeds the minimum primary inter-aperture gap 1412. It should be understood that this ensures that the skin bridges separating the cut TEPR epidermis do not narrow and cause the epidermis to merge, which is detrimental to healing. Additionally, it should be understood that the primary template 1402 and the secondary template 1406 can vary in size, shape, and orientation to address all shapes and sizes of tattooed eyebrows. Furthermore, the border 1416 can define the area that the primary template 1402 and the secondary template 1406 can cover.
[0175] Referring again to Figures 18-19 , examples of constructing and defining apertures on the cover temples described herein are described below. The primary apertures 1404 and the secondary apertures 1408 can have various shapes and sizes, and are rounded quadrilaterals. That is, the primary apertures 1404 and the secondary apertures 1408 can be quadrilaterals with rounded corners. It should be understood that the primary apertures 1404 and the secondary apertures 1408 and other cover template apertures can include rounded corners to accommodate TEPR wire brushes with compact six-in-a-pack needles that are about 1 millimeter in diameter. Thus, a rounded quadrilateral is a closed curvilinear figure defined by four circular arcs tangent to four interconnected line segments. Each rounded quadrilateral is completely defined by the centers of the four circular arcs (the upper point 1420 and the lower point 1422 in Figure 18 ) and the four circular arc radii. All of the examples described below can include rounded corners with the same radii as described above. Given a common corner radius, only the center points positioning the rounded corners need to be specified to complete the construction of the template apertures.
[0176] The rounded corner center points are located at the intersection of the primary border 1416 and the secondary border 1418 with near perpendiculars 1419 that are almost perpendicular to the center arcs on both the primary template 1402 and the secondary template 1406. These near perpendiculars 1419 are represented by the line segments connecting the upper point 1420 and the lower point 1422. In order to keep the gap between the apertures constant without any tapering (so that the TEPR cut skin bridges have a uniform width), the adjacent aperture sides and their associated near perpendiculars must be parallel to each other. They are also parallel to the true perpendiculars of the arc 1410, which for the primary template 1402 is always in the middle of the gap between adjacent apertures.
[0177] The curvilinear arc 1410 defining the stripe pattern bisects the head (the truncated left end in Figure 18 ) of the primary template and the tail (the pointed right end in Figure 18 ) of the primary template. These two bisectors are connected by a tangent line whose radius is chosen to fit the shape of the eyebrow.
[0178] Once the arc is constructed, the intersection of the true perpendiculars are spaced along the arc by arc lengths. Two arc lengths measured along the arc 1410, the primary aperture width, and the primary gap between adjacent apertures establish these points. Once the true perpendiculars are established, parallel near-perpendiculars 1419 can be established, which define the primary apertures. Figure 18 A primary stencil pattern is shown covered by a striped primary aperture 1404 that covers exactly the particular eyebrow shape. In the primary stencil 1402, as previously described, the primary gap 1412 between the primary apertures 1404 (maintaining the skin bridge distance) is designed to be uniform, without any tapering.
[0179] It should be understood that, Figures 18-20 The stencils 1402, 1406 shown demonstrate stencils that are tailored to the exact eyebrow shape. Thus, the apertures on the tailored stencils, such as the primary apertures 1404 and the secondary apertures 1408, can be increased or decreased in height (particularly along the tapered tail) to fit the eyebrow shape. Referring to Figure 21 Because of the great variability of eyebrow shapes, in one embodiment, a universal stencil 1500 can be constructed by extending (or at least not decreasing) the height of the universal aperture 1502 along the arc 1504.
[0180] When marking the eyebrows in preparation for TEPR treatment, the film is marked only on the inked skin. Even though the stencil apertures, such as the primary apertures 1404, the secondary apertures 1408, and the universal aperture 1502, can extend significantly beyond the tattooed eyebrows, the actual treatment film will only extend to the ink. Any extended height apertures merely enable the stencil to fit a greater variety of inked shapes. Additionally, the tailored stencils are inherently asymmetric, and thus cannot fit both left and right eyebrows simultaneously. Two left and right mirrored stencils will be used to fit the left and right eyebrows, respectively.
[0181] In some embodiments, as Figure 22 shown, a single stencil or symmetric stencil 1600 fits both the right eye and the left eye. The symmetric stencil can include an aperture 1602. The symmetric stencil 1600 can be constructed from an arc 1604 characterized by one dimensionless parameter: the maximum height-to-length ratio. In this case, two or three symmetric stencils with different arc lengths (maximum height-to-length ratios) can cover a variety of eyebrow shapes.
[0182] Because of the tent-like shape of the symmetric stencil 1600, the stencils can nest within each other. For example, as Figures 23-24As shown, multiple symmetrical stencils can be nested to create a first tri-stencil 1700 and a second tri-stencil 1702. In one embodiment, the first tri-stencil 1700 and the second tri-stencil 1702 comprise a 4.0 inch wide by 3.5 inch high rectangle. Each tri-stencil 1700, 1702 is comprised of three stencils, any of which can be peeled off and used independently. Specifically, the first tri-stencil 1700 includes three high-arch stencils 1704A-1704C, while the second tri-stencil 1702 includes three short-arch stencils 1706A-1706C. While three stencils are shown, it should be understood that some nested stencils include two or more stencils. Each stencil in the first tri-stencil 1700 includes a similar size and shape aperture. However, due to the curvature of the arch, the apertures differ between the stencils in the tri-stencil set. In some embodiments, the arch increases as the stencils are stacked one after another in the first tri-stencil 1700 and the second tri-stencil 1702. For example, the stencil with the smallest arch can be located at the bottom of the first tri-stencil 1700 and the second tri-stencil 1702. For example, stencils 1704C and 1706C can be the stencils with the smallest arch.
[0183] Figure 23 The first tri-stencil 1700 shown is designed to work with high-arched eyebrows (or thicker, depending on how one defines the vertical extension of the eyebrow), such as eyebrows up to 10 mm. Thus, the first tri-stencil 1700 includes first apertures 1708, which can be narrow rectangular areas. In one embodiment, the rectangular area is no more than 40 mm 2 Thus, the tri-stencil 1700 includes high and narrow apertures.
[0184] Referring to Figure 24 , the second tri-stencil 1702 includes second apertures 1710 that are shorter than the first apertures 1708. In one embodiment, the second apertures 1710 include a 36 mm 2 rectangular aperture area. The second tri-stencil 1702 can be used to work with shorter eyebrows (or narrower, depending on how one defines the vertical extension of the eyebrow). In one embodiment, the second apertures 1710 can include a 6 mm height and width, and the gaps between the second apertures 1710 can be spaced 5 mm apart. Thus, there are fewer apertures on the second tri-stencil 1702 than on the first tri-stencil 1700. Both the first tri-stencil 1700 and the second tri-stencil 1702 work with eyebrows that are either high or short and have the same range of arches.
[0185] When using the overlay stencil marking process described above to mark a film, the vertical extension of the marked film never substantially exceeds the height of the inked skin. The stencil apertures provide the width and location of the film, as well as the maximum limit of its height, while the inked skin determines its precise vertical range.
[0186] Each of the overlay templates discussed above can include a sheet of material, which can be made of silicone, polypropylene, or any other material. In some embodiments, the sheet of material can be flexible to conform to the non-planar surface of a patient's face. In some embodiments, the sheet of material can be flexible while not stretching. The sheet of material can include an adhesive layer on the lower surface of the sheet of material that allows the overlay template to be held in place while the markings are applied. The adhesive layer can include any suitable adhesive. For example, the adhesive layer can be an acrylate, including methacrylate and epoxy diacrylate. Alternatively, the adhesive layer can be a silicone-based adhesive. The adhesive layer can co-extend with the lower surface in a pattern or any other manner on the lower surface.
[0187] In some embodiments, a separate adhesive or tape can be used to secure the template in place. In some embodiments, a tension band or strap is used to hold the template in place, or any other mechanism for quickly, safely, and easily attaching the template to the patient. Additionally, a release liner can releasably adhere to the adhesive layer. The release liner can protect the adhesive layer from prematurely adhering to unwanted locations, and can be removed from the template prior to application to the epidermis. Once the release liner is removed, the user can place the overlay template on the patient to mark the epidermis. Once the epidermis is marked, the user can remove the overlay template to begin treatment, or can leave the template behind to act as a guide during treatment. Additionally, in some cases, the user can hold the template with their non-dominant hand while marking the epidermis with their dominant hand. Alternatively, the user can hold and support the template by using a handle device.
[0188] In the above description, certain terms can be used such as "upper," "lower," "up," "down," "top," "bottom," "horizontal," "vertical," "left," "right," "over," "under," and / or the like. Where the context permits, these terms are used to provide some clarity of description. However, these terms do not mean absolute relationship, position, and / or orientation. For example, a "top" surface of an object can simply become a "bottom" surface by turning the object over. However, it is still the same object. Additionally, the terms "comprise," "comprising," "have," "having," "include," "including," and / or the like are meant to be "including but not limited to," unless explicitly specified otherwise. Lists of items are meant to be "one or more," unless explicitly specified otherwise. The terms "a" and "the" are also meant to be "one or more," unless explicitly specified otherwise. Additionally, the term "plurality" can be defined as "at least two."
[0189] Furthermore, where an element or layer is described as being "on" or "connected to" another element or layer, it can be directly on or connected to the other element or layer, or intervening elements or layers can be present. In contrast, when an element is referred to as being "directly on" or "directly connected to" another element or layer, there are no intervening elements or layers present. Also, as used herein, the term "and / or" means "and" or "or", for example, and is used to indicate one or more of the stated conditions can be fulfilled.
[0190] As used herein, the phrase "at least one of' is used to mean that one or more of the listed items can be used, and that the listed items can be used individually or in any combination. The item can be a specific object, thing, or category. In other words, "at least one of' means that any combination of the items or number of items from the list can be used, but not necessarily all of the items from the list. For example, "at least one of item A, item B, and item C can mean item A; item A and item B; item B; item A, item B, and item C; or item B and item C. In some cases, "at least one of item A, item B, and item C can mean, for example and without limitation, two of item A, one of item B, and ten of item C; four of item B and seven of item C; or some other suitable combination.
[0191] The terms "first," "second," and the like, as used herein do not imply a sequence or order unless clearly indicated by the context. Also, a reference to "one or more of' something is not a reference to "one, and not the other" unless clearly indicated by the context.
[0192] As used herein, a system, apparatus, structure, article, element, component, or hardware configured to perform a particular function is indeed capable of performing the particular function, without any further modification, rather than merely having the potential to perform the particular function after a further modification. In other words, a system, apparatus, structure, article, element, component, or hardware configured to perform a particular function is specifically selected, created, implemented, utilized, programmed, and / or designed to perform the particular function. As used herein, "configured to" means an existing feature of a system, apparatus, structure, article, element, component, or hardware that enables the system, apparatus, structure, article, element, component, or hardware to perform a specified function without further modification. For purposes of this disclosure, a system, apparatus, structure, article, element, component, or hardware described as "configured to" perform a particular function can additionally or alternatively be described as "adapted to" and / or "operative to" perform the function.
[0193] The above-described schematic flowcharts and method diagrams are generally set forth as logical flowcharts. As such, the depicted order and labeled steps are indicative of representative embodiments. Other steps, orders and methods can be conceived that are equivalent in function, logic, effect of these method steps or portions thereof.
[0194] Further, the format and symbols used in connection with the schematic diagrams are provided to explain the logical steps in a particular manner. It is understood that the schematic diagrams are not limited to the specific method steps illustrated. Although various arrow types and line types can be employed in the schematic diagrams, they are not intended to convey information exclusively about flow of the method in question. Rather, some arrows or other connectors can be used to convey possible relationships between various steps or methods depicted in the schematic diagrams. Further, the order in which a particular method occurs can or can not strictly adhere to the order shown in the corresponding steps.
[0195] The present subject matter can be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The described embodiments are to be considered in all respects only as illustrative and not restrictive. All changes coming within the meaning and equivalency of the claims are intended to be embraced therein.
[0196] In the above description, specific details of various embodiments are provided. However, some embodiments can be practiced without using all of the specific details described. In other instances, some methods, processes, components, structures and / or functions are described in detail, without unnecessary detail, for clarity and conciseness.
[0197] While specific embodiments of the application have been described and illustrated, the application is not to be limited to the specific forms or arrangements of parts so described and illustrated. The scope of the area of the application is defined by the claims appended hereto and equivalents thereof.
Claims
1. A system for tattoo eyebrow removal, the system comprising: a primary stencil comprising a curved arc that bisects a head of the primary stencil and a tail of the primary stencil and comprising primary apertures, the primary stencil defining a first treatment area of a patient's skin, the primary stencil being affixed to the patient's skin and marking the first treatment area of the patient's skin along a boundary of the primary apertures to outline a primary envelope, and the primary stencil being adapted for use in a first treatment phase to destroy tissue in the primary envelope to form a scab; a secondary stencil comprising secondary apertures for marking a second treatment area of the skin comprising a secondary envelope interposed between the primary envelope, the secondary stencil being adapted for use in a second treatment phase to destroy the tissue in the secondary envelope; wherein at least one of the primary apertures is tapered such that a stripe pattern of primary apertures is curved along the curved arc of the primary stencil.
2. The system of claim 1, wherein the primary stencil comprises primary interstitial gaps interposed between the primary apertures.
3. The system of claim 2, wherein the primary interstitial gaps comprise uniform widths.
4. The system of claim 2, wherein the secondary stencil comprises secondary apertures corresponding to the interstitial gaps in the primary stencil.
5. The system of claim 4, wherein the secondary apertures comprise uniform widths.
6. The system of claim 2, wherein the secondary envelope is marked by assaying residual tattoo ink after the primary treatment.
7. The system of claim 2, wherein the secondary stencil is flexible to conform to a non-planar surface of the patient's skin.
8. The system of claim 2, wherein the primary stencil is flexible to conform to a non-planar surface of the patient's skin.
9. The system of claim 2, wherein the primary stencil comprises an adhesive layer on a lower surface of the primary stencil.
10. The system of claim 2, further comprising a tissue destruction device that applies mechanical destruction to the tissue.
11. The system of claim 2, further comprising a tissue destruction device that applies a temperature change to the tissue.
12. The system of claim 2, further comprising a tissue destruction device that applies an acid to the tissue.
13. The system of claim 2, further comprising a tissue destruction device that applies radiation to the tissue.
Citation Information
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