Methods and devices for treating the skin

Abstract

A method of directional skin tightening by fractionated treatment is provided, the method comprising creating a plurality of excised tissue portions in an area of ​​dermal tissue, the method comprising applying a contraction or expansion tension to the area of ​​dermal tissue in at least one predetermined direction, the applying a contraction or expansion tension to the area of ​​dermal tissue promotes collagen proliferation and directional skin tightening in the area of ​​dermal tissue.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 161,471, filed March 16, 2021, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to methods and devices for skin treatment, more particularly to methods and devices for skin coring and tightening that benefit from supporting collagen proliferation and achieving directional skin tightening in said skin tissue, thereby achieving skin repair or tightening. [Background technology]

[0003] Excess tissue and skin laxity are significant problems in aesthetic medicine, with many patients currently undergoing invasive surgical procedures, such as facelifts, to treat such conditions. Summary of the Invention [Problem to be solved by the invention]

[0004] The present invention discloses a minimally invasive device for skin tightening. Furthermore, the directional tightening device ablates micro-cores of the skin to produce a desired aesthetic appearance.

[0005] In aesthetic medicine, the removal of excess tissue and / or skin laxity is a significant challenge affecting over 25% of the U.S. population. Traditional surgical treatments (e.g., facelifts, browlifts, or breastlifts) can be effective, but are often invasive, inconvenient, and expensive, while scarring limits the applicability of those treatments.

[0006] Removing 5%-15% of the skin over an area by excising multiple <1 mm diameter dermal cores and applying directional compression elastic bandages has been shown to result in skin tightening that can be tailored in any desired direction without (noticeable) scarring. Automated robotic dermal microcoring systems with machine vision and robotic precision can provide the precision, reproducibility, and efficiency that provide high value to the clinic.

[0007] Methods using energy sources (e.g., laser, non-coherent light, radio frequency, or ultrasound) can be effective in improving skin structure and texture, but are less effective in tightening the skin or reducing skin laxity. Neurotoxins such as botulinum toxin reduce the formation of dynamic wrinkles due to the paralysis of injected muscles, but such toxins have minimal or no effect on firmness or laxity. Finally, dermal fillers such as hyaluronic acid are injected into the dermis layer to smooth wrinkles and improve contours, but such fillers do not tighten the skin or reduce skin laxity. Therefore, surgical treatment remains the gold standard for lifting and / or tightening the skin.

[0008] Rotational fractionated resection ("RFR") is a procedure that may be used to achieve localized aesthetic contouring by removing loose skin and excess adipose tissue from a patient. Skin may be removed by use of a rotating microcoring punch, a hollow, sharp tube that performs full-thickness dermal resection. Such punches are adapted to treat scars, acne scars, lines, wrinkles, stretch marks, melasma, improve skin texture, and tighten skin, among other conditions. As the punch creates small holes in the top layer of skin, such holes trigger the body's healing process, which allows such instruments the opportunity for the treatment area to heal with less discoloration and / or deformation and greater smoothness on the surface.

[0009] However, such methods are not without problems and there is still a need to improve their effectiveness.Therefore, there is a need for improved methods and devices that improve the effectiveness of such minimally invasive techniques.Furthermore, there remains a long-felt need for an automated robotic system for dermal microcoring used in minimally invasive directional skin tightening procedures. [Means for solving the problem]

[0010] The present invention relates to methods and devices for skin treatment, more particularly to methods and devices for skin coring and tightening that benefit from supporting collagen proliferation and achieving directional skin tightening in said skin tissue, thereby achieving skin repair or tightening.

[0011] One object of the present invention is to provide a method for directional skin tightening comprising the steps of: (i) creating a plurality of excised tissue portions within an area of ​​skin tissue; (ii) applying to the area of ​​skin a stretching / compressing device having at least two parts adapted to contract or expand said area of ​​skin in at least one predetermined direction; (iii) securing at least a portion of the stretching / compression device to the skin; (iv) applying tension between the two portions to effect directional skin tightening in the skin tissue; The object of the present invention is to provide a method comprising the steps of:

[0012] Another object of the present invention is to provide a method as defined above, wherein said step of fixing at least a part of said stretching / compressing device to said skin contracts said area of ​​skin in said predetermined direction.

[0013] Another object of the invention is to provide a method as defined above, further comprising the step of fixing a second part of said stretching / compressing device to said skin.

[0014] Another object of the present invention is to provide a method as defined above, wherein the step of applying tension between the two parts further comprises the step of fixing a second part of the stretching / compression device to the skin and pulling one part relative to the other part.

[0015] It is another object of the present invention to provide a method as defined above, wherein said extension / compression device comprises a long portion and a short portion, said short portion comprising at least one buckle-like element having at least one slotted hole, and further wherein said long portion is adapted to be in physical communication with said short portion by being threaded through said at least one slotted hole and secured to said short portion.

[0016] Another object of the invention is to provide a method as defined above, wherein said long portion comprises at least one adhesive layer adapted to ensure attachment of said short portion to said long portion.

[0017] Another object of the invention is to provide a method as defined above, wherein said short portion comprises at least one adhesive layer adapted to ensure attachment between said short portion and said long portion.

[0018] Another object of the invention is to provide a method as defined above, wherein said long portion comprises a Velcro adapted to secure the attachment of said short portion to said long portion.

[0019] Another object of the invention is to provide a method as defined above, wherein said short portion comprises a Velcro adapted to secure the attachment of said short portion to said long portion.

[0020] Another object of the present invention is to provide a method for manufacturing a semiconductor device comprising the steps of: 2 ~40N / mm 2 The object of the present invention is to provide a method as defined above, which applies a force in the range of

[0021] Another object of the present invention is to provide a method as defined above, wherein the tension applied in the step of applying tension between the two parts is adjustable based on at least one parameter selected from the group consisting of skin type, patient age, type of treatment, and any combination thereof.

[0022] Another object of the present invention is to provide a method as defined above, wherein said step of applying tension between said two parts is performed in a direction selected from the group consisting of x-, y- and / or z-directions and any combination thereof relative to said stretching / compression device and said skin to effect said directional tightening.

[0023] Another object of the present invention is to provide a method as defined above, wherein said stretching / compression device comprises at least one occlusive layer adapted to control wettability and / or promote wound healing of said skin.

[0024] Another object of the invention is to provide a method as defined above, wherein said stretching / compression device comprises at least one absorbent layer adapted to absorb wound exudate.

[0025] Another object of the present invention is to provide a method as defined above, wherein said stretching / compression device is provided in skin tone or is transparent or translucent.

[0026] Another object of the present invention is to provide a method as defined above, wherein the step of creating a plurality of excised tissue portions in an area of ​​skin tissue is performed by a system comprising at least one robotic arm, said at least one robotic arm comprising at least one skin coring device.

[0027] Another object of the present invention is to provide a method as defined above, wherein said at least one skin coring instrument comprises at least one punch configured to contact a surface of the skin to generate a hole in the skin tissue by an excised portion of the skin tissue.

[0028] Another object of the present invention is to provide a method as defined above, wherein said at least one punch is at least three punches.

[0029] Another object of the present invention is to provide a skin coring device comprising: a micro-coring punch including at least six micro-coring needles; a mechanism configured to rotate each of the micro-coring needles about at least one axis of symmetry of each needle, wherein the rotation of each of the micro-coring needles is synchronized with the rotation of the remaining micro-coring needles; a mechanism configured to advance a micro-coring punch toward the skin and penetrate the skin to a depth of at least 2 millimeters; a mechanism configured to step the micro-coring punch and position the micro-coring punch such that two facets of the stepped micro-coring punch hexagon intersect two facets of the first micro-coring punch hexagon; The object of the present invention is to provide a method as defined above, comprising:

[0030] Another object of the present invention is to provide a method as defined above, wherein the micro-coring punch is mounted on a computer-controlled robotic arm capable of moving in six or more axes (degrees of freedom).

[0031] Another object of the invention is to provide a method as defined above, in which a computer-controlled robotic arm manipulates a micro-coring punch containing five micro-coring needles.

[0032] Another object of the present invention is to provide a method as defined above, further comprising a video camera configured to provide visual feedback of at least the micro-coring punch and the skin, and a closed-loop force sensor for determining when the punch breaks the skin.

[0033] Another object of the invention is to provide a method as defined above, wherein the five micro-coring needles are at the vertices of a pentagonal pattern.

[0034] Another object of the invention is to provide a method as defined above, wherein the area between the two intersecting facets of the first hexagon and the two facets of the stepped hexagon forms a rhombus.

[0035] Another object of the invention is to provide a method as defined above, wherein the diamond shape comprises at least two micro-coring needles positioned at opposite apexes of the diamond shape.

[0036] Another object of the invention is to provide a method as defined above, in which at least one vortex of the stepped hexagon is located on an inscribed circle having a diameter equal to half the diameter of the hexagon.

[0037] Another object of the present invention is to provide a method as defined above, in which the rotation of each of the micro-coring needles is synchronized with the rotation of the remaining micro-coring needles.

[0038] Another object of the present invention is to provide a method as defined above, wherein the mechanism configured to synchronize the rotation of each of the micro-coring needles with the rotation of the remaining micro-coring needles is one of the group of mechanisms consisting of gears or friction belts.

[0039] Another object of the present invention is to provide a method as defined above, wherein the micro-coring punch advances towards the skin and penetrates the skin to a depth of at least 2 millimeters.

[0040] Another object of the present invention is to provide a method as defined above, wherein the mechanism configured to advance the micro-coring punch towards and penetrate the skin is one of a group of mechanisms consisting of a robotic arm or a screw.

[0041] Another object of the present invention is to provide a method as defined above, wherein at least a part of said at least one punch is disposable.

[0042] Another object of the invention is to provide a method as defined above, wherein said at least one punch is adapted to penetrate said skin simultaneously or sequentially.

[0043] Another object of the invention is to provide a method as defined above, wherein said at least one punch is characterized by either a similar cross-sectional area or by substantially different cross-sectional areas.

[0044] Another object of the invention is to provide a method as defined above, wherein said at least one punch is adapted to penetrate said skin to a depth of between 1 mm and 4 mm.

[0045] Another object of the invention is to provide a method as defined above, wherein at least a part of said at least one punch is characterized by a radius between 0.15 mm and 1.0 mm, i.e. between 0.6 mm and 0.75 mm.

[0046] Another object of the present invention is to provide a method as defined above, wherein said cross-sectional area is selected from the group consisting of a circle, a rectangle, a triangle, a hexagon, an ellipse, a staggered array, a parallel array, a spiral pattern, a square or rectangular pattern, a radial distribution, and any combination thereof.

[0047] Another object of the invention is to provide a method as defined above, wherein said system further comprises at least one controller adapted to control the positioning of said at least one robotic arm relative to said skin area.

[0048] Another object of the present invention is to provide a method as defined above, wherein said controller comprises at least one engine adapted to control at least one parameter selected from the group consisting of rotation, translation, penetration angle of said at least one robotic arm relative to said skin, penetration depth, coverage, diameter of at least one excised tissue multiplied by number of cores, different areas of said skin to be treated, and any combination thereof.

[0049] Another object of the invention is to provide a method as defined above, wherein said parameters are manually adjusted by an operator or automatically adjusted by said controller.

[0050] Another object of the invention is to provide a method as defined above, in which said parameters are adjusted in real time.

[0051] Another object of the present invention is to provide a method as defined above, wherein said speed of rotation is between 1000 RPM and 7000 RPM, i.e. in the range of 3000 RPM to 7000 RPM.

[0052] Another object of the invention is to provide a method as defined above, wherein the speed of said translation ranges from 0 mm / s to 500 mm / s.

[0053] Another object of the invention is to provide a method as defined above, wherein the translation of the at least one robotic arm relative to the skin varies as the at least one robotic arm approaches the skin.

[0054] Another object of the invention is to provide a method as defined above, wherein said rotation of said at least one robotic arm varies as said at least one robotic arm approaches and penetrates the skin.

[0055] Another object of the invention is to provide a method as defined above, in which each of said at least one punch rotates individually in a predetermined direction, it being emphasized that each of the punches can rotate in a different direction.

[0056] Another object of the invention is to provide a method as defined above, in which all of said punches rotate simultaneously.

[0057] Another object of the invention is to provide a method as defined above, wherein each punch of said at least one punch translates individually.

[0058] Another object of the invention is to provide a method as defined above, in which all of said punches translate simultaneously.

[0059] Another object of the invention is to provide a method as defined above, wherein said controller comprises a stop mechanism adapted to limit the depth to which said at least one punch penetrates said skin.

[0060] Another object of the invention is to provide a method as defined above, wherein said penetration angle is substantially perpendicular to said skin.

[0061] Another object of the present invention is to provide a method as defined above, wherein said controller is adapted to define at least one no-fly zone, said no-fly zone being defined as an area in which said system does not apply treatment.

[0062] Another object of the present invention is to provide a method as defined above, wherein said system further delivers an additive to the skin.

[0063] Another object of the present invention is to provide a method as defined above, wherein said additive is selected from the group consisting of: a therapeutic agent, saline growth factor, platelet derived growth factor (PDGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), epidermal growth factor (EGF), and keratinocyte growth factor; one or more stem cells; a steroid, an agent for preventing post-inflammatory skin hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungals; one or more anti-inflammatory agents, or mineralocorticoid agents, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; a foam; or a hydrogel, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, procoagulants, antifibrinolytic agents, one or more procoagulants, one or more anticoagulants, one or more immunomodulators including corticosteroids and non-steroidal immunomodulators, one or more proteins; or one or more vitamins and any combination thereof.

[0064] Another object of the present invention is to provide a method as defined above, wherein said system further comprises at least one imaging subsystem adapted to guide said at least one skin coring instrument.

[0065] Another object of the present invention is to provide a method as defined above, wherein said imaging subsystem comprises at least one selected from the group consisting of at least one camera, subcutaneous imaging such as ultrasound-based imaging, OCT, and any combination thereof.

[0066] Another object of the present invention is to provide a method as defined above, wherein said system further comprises at least one vacuum subsystem adapted to provide suction to remove the excised portion of said skin tissue.

[0067] Another object of the present invention is to provide a method as defined above, wherein said skin may be part of a treatment area selected from the group consisting of forehead, cheeks, jawline, neck, upper arms, stomach, abdomen, face, eyelids, nose, forehead, chin, forehead, lips, nose, neck, thighs, chest, legs, back and any combination thereof.

[0068] Another object of the present invention is to provide a method as defined above used for localized removal of excess dermal tissue for skin tightening, at least partial scar removal, skin rejuvenation, at least partial removal of pigment, at least partial tattoo removal, veins, acne, allodynia, age spots, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigines or keratoses, loss of transparency, loss of elasticity, melasma, photodamage, xerosis, fine lines, wrinkles, paleness, scar contracture, scarring, wrinkles, folds, acne scars, dyschromia, striae, surgical scars, cellulite, tattoo removal, malar lines, facial lines, facial folds, skin aging, skin contraction, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangiomas, papules, port wine stains, rosacea, venules reticulata, or telangiectasias, or any other undesirable skin abnormality and any combination thereof.

[0069] Another object of the present invention is to provide a method as defined above, wherein said system utilizes at least one selected from the group consisting of mechanical visualization, OCT, ultrasound to image the treatment area and utilizes at least one selected from the group consisting of machine learning algorithms, artificial intelligence, image processing, and any combination thereof to efficiently select preferred locations of the tissue to be treated to improve the outcome of said treatment.

[0070] Another object of the present invention is to provide a method as defined above, wherein the area percentage of the ablated tissue portion is less than about 70% of the skin area.

[0071] Another object of the present invention is to provide a method as defined above, wherein the area percentage of the ablated tissue portion is less than about 10% of the skin area.

[0072] Another object of the present invention is to provide a method as defined above, wherein the area percentage of the excised tissue portion is between about 5% and about 30% of the skin area.

[0073] Another object of the invention is to provide a method as defined above, comprising a step of pre-stretching the skin area prior to the step of creating a plurality of excised tissues.

[0074] Another object of the present invention is a method for dermal microcoring, comprising: providing a micro-coring punch including six micro-coring needles; applying a micro-coring punch to at least one segment of skin to perform at least one micro-coring process; A method for dermal coring comprising: A dermal coring method is provided in which the micro-coring punch is positioned such that each successive micro-coring punch has at least one facet of a stepped micro-coring punch hexagon intersecting one facet of the previous hexagon.

[0075] Another object of the present invention is to provide a method as defined above, wherein each successive micro-coring punch is positioned such that at least two facets of the stepped micro-coring punch hexagon intersect two facets of the previous hexagon.

[0076] Another object of the present invention is to provide a method as defined above, wherein each micro-coring punch applied to said at least one segment of skin comprises stepping the micro-coring punch in at least one of the X and Y directions.

[0077] Another object of the present invention is to provide a method as defined above, wherein each successive micro-coring punch comprises stepping the micro-coring punch a distance at least equal to the radius of a circle inscribed by the hexagonal pattern.

[0078] Another object of the present invention is to provide a method as defined above, wherein stepping the micro-coring punch at a distance equal to the diameter of a circle inscribed by the hexagonal pattern forms a plurality of hexagons having a radius twice the original hexagon radius.

[0079] Another object of the present invention is to provide a method as defined above, in which five micro-coring needles are positioned at the vertices of a pentagonal pattern.

[0080] Another object of the invention is to provide a method as defined above, wherein the area between the two intersecting facets of the first hexagon and the two facets of the stepped hexagon forms a rhombus.

[0081] Another object of the invention is to provide a method as defined above, wherein the diamond shape comprises at least two micro-coring needles positioned at opposite apexes of the diamond shape.

[0082] Another object of the invention is to provide a method as defined above, in which at least one vortex of the stepped hexagon is located on an inscribed circle having a diameter equal to half the diameter of the hexagon.

[0083] Another object of the present invention is to provide a method as defined above, whereby following skin coring, positive pressure is applied (squeezing) and the circular hole is compressed to obtain optimal skin healing and aesthetic skin tightening results.

[0084] Another object of the invention is to provide a method as defined above, in which said step of rotating each of the micro-coring needles is performed about at least one axis of symmetry.

[0085] Another object of the present invention is to provide a method as defined above, in which the rotation of each of the micro-coring needles is synchronized with the rotation of the remaining micro-coring needles.

[0086] Another object of the present invention is to provide a method as defined above, wherein the micro-coring punch is advanced towards the skin and penetrates the skin to a depth of at least 2 millimeters.

[0087] Another object of the present invention is to provide a method as defined above, in which a vacuum is used to draw the incised skin cores through a tube and into a waste canister.

[0088] Another object of the invention is to provide a method as defined above, in which a tube is flushed with a liquid to remove blockages therein.

[0089] Another object of the invention is to provide a method as defined above, in which the punch is aligned perpendicular to the skin.

[0090] Another object of the present invention is to provide a method as defined above that uses a closed-loop force sensor and visual feedback to determine when the punch breaks the skin.

[0091] Another object of the invention is to provide a method as defined above which retracts the punch and moves the punch to the next treatment position.

[0092] Another object of the present invention is to provide a dermal micro-coring device, comprising: a micro-coring punch containing six micro-coring needles; a mechanism configured to rotate each of the micro-coring needles about at least one axis of symmetry of each needle, wherein the rotation of each of the micro-coring needles is synchronized with the rotation of the remaining micro-coring needles; a mechanism configured to advance a micro-coring punch toward the skin and penetrate the skin to a depth of at least 2 millimeters; a mechanism configured to step the micro-coring punch and position the micro-coring punch such that one facet of the stepped micro-coring punch hexagon intersects one facet of the first micro-coring punch hexagon; The object of the present invention is to provide an apparatus comprising:

[0093] It is another object of the present invention to provide an apparatus as defined above, wherein the mechanism is configured to step the micro-coring punch and position the micro-coring punch such that two facets of the stepped micro-coring punch hexagon intersect two facets of the first micro-coring punch hexagon.

[0094] Another object of the present invention is to provide an apparatus as defined above, wherein the micro-coring punch is mounted on a computer-controlled robotic arm capable of moving in six or more axes (degrees of freedom).

[0095] Another object of the present invention is to provide an apparatus as defined above, in which a computer-controlled robotic arm manipulates the micro-coring punch (containing six micro-coring needles).

[0096] Another object of the invention is to provide a device as defined above, in which six micro-coring needles are utilized.

[0097] Another object of the present invention is to provide an apparatus as defined above, in which the rotation of each of the micro-coring needles is synchronized with the rotation of the remaining micro-coring needles.

[0098] It is another object of the present invention to provide an apparatus as defined above, wherein the mechanism configured to synchronize the rotation of each of the micro-coring needles with the rotation of the remaining micro-coring needles is one of the group of mechanisms consisting of gears or friction belts.

[0099] Another object of the invention is to provide a device as defined above, in which the step of the micro-coring punch is at least equal to half the radius of the circle inscribed by the hexagon.

[0100] Another object of the invention is to provide a device as defined above, in which the area between the two intersecting facets of the first hexagon and the two facets of the stepped hexagon forms a rhombus.

[0101] Another object of the invention is to provide a device as defined above, wherein the diamond shape comprises at least two micro-coring needles positioned at opposite apexes of the diamond shape.

[0102] Another object of the invention is to provide a device as defined above, in which at least one vortex of the stepped hexagon is located on an inscribed circle having a diameter equal to half the diameter of the hexagon.

[0103] Another object of the present invention is to provide an apparatus as defined above, further comprising a video camera configured to provide visual feedback of at least the micro-coring punch and the skin, and a closed-loop force sensor for determining when the punch breaks the skin.

[0104] Another object of the present invention is to provide a device as defined above, wherein the micro-coring punch advances towards the skin and penetrates the skin to a depth of at least 2 millimeters.

[0105] Another object of the present invention is to provide a device as defined above, wherein the mechanism configured to advance the micro-coring punch towards and penetrate the skin is one of a group of mechanisms consisting of a robotic arm or a screw.

[0106] Another object of the present invention is to provide an apparatus as defined above, wherein the mechanism configured to synchronize the rotation of each of the micro-coring needles with the rotation of the remaining micro-coring needles is one of a group of mechanisms consisting of gears or friction belts.

[0107] Another object of the present invention is a method for increasing the density of dermal micro-coring holes, comprising: providing a micro-coring punch including five micro-coring needles arranged in a pentagonal pattern with a sixth micro-coring needle at a center; applying the micro-coring punch to a segment of skin to perform a first micro-coring operation; stepping the micro-coring punch to treat a second skin segment; A method comprising: The next step for each of the micro-coring punches is to provide a method for positioning the micro-coring punches such that the second and subsequent hexagonal whorls lie on an inscribed circle having a diameter equal to half the diameter of the hexagon.

[0108] Another object of the present invention is to provide a method as defined above, in which the second and subsequent hexagons of each of the micro-coring punches are positioned such that the two facets of the second and subsequent hexagons intersect the two facets of the preceding hexagon.

[0109] Another object of the invention is to provide a method as defined above, wherein the distance between two adjacent core rings is half the radius of the hexagon.

[0110] Another object of the present invention is to provide a method as defined above, wherein a second micro-coring punch (larger than the first micro-coring punch) is positioned coaxially with the first micro-coring punch.

[0111] Another object of the invention is to provide a device for dermal microcoring of a segment of a skin area and its directional tightening, comprising: a micro-coring punch including at least one micro-coring needle, preferably five arranged in a pentagonal pattern with a sixth micro-coring needle at the center; a mechanism configured to rotate each of the micro-coring needles about at least one axis of symmetry of each needle, wherein the rotation of each of the micro-coring needles is synchronized with the rotation of the remaining micro-coring needles; a mechanism configured to step a micro-coring punch toward the skin and penetrate the skin to a depth of at least 2 millimeters; a mechanism configured to step the micro-coring punch and position the micro-coring punch such that two facets of the stepped micro-coring punch hexagon intersect two facets of the first micro-coring punch hexagon; The object of the present invention is to provide an apparatus as defined above, comprising:

[0112] Another object of the invention is to provide a device as defined above, wherein said at least one micro-coring needle is five micro-coring needles.

[0113] Another object of the present invention is to provide an apparatus as defined above, wherein the micro-coring punch is mounted on a computer-controlled robotic arm capable of moving in six or more axes (degrees of freedom).

[0114] Another object of the present invention is to provide an apparatus as defined above, in which a computer-controlled robotic arm manipulates a micro-coring punch containing six micro-coring needles.

[0115] Another object of the present invention is to provide an apparatus as defined above, further comprising a video camera configured to provide visual feedback of at least the micro-coring punch and the skin, and a closed-loop force sensor for determining when the punch breaks the skin.

[0116] Another object of the invention is to provide a device as defined above, in which the five micro-coring needles are at the vertices of a pentagonal pattern.

[0117] Another object of the invention is to provide a device as defined above, in which the area between the two intersecting facets of the first hexagon and the two facets of the stepped hexagon forms a rhombus.

[0118] Another object of the invention is to provide a device as defined above, wherein the diamond shape comprises at least two micro-coring needles positioned at opposite apexes of the diamond shape.

[0119] Another object of the invention is to provide a device as defined above, in which at least one vortex of the stepped hexagon is located on an inscribed circle having a diameter equal to half the diameter of the hexagon.

[0120] Another object of the present invention is to provide an apparatus as defined above, in which the rotation of each of the micro-coring needles is synchronized with the rotation of the remaining micro-coring needles.

[0121] It is another object of the present invention to provide an apparatus as defined above, wherein the mechanism configured to synchronize the rotation of each of the micro-coring needles with the rotation of the remaining micro-coring needles is one of the group of mechanisms consisting of gears or friction belts.

[0122] Another object of the present invention is to provide a device as defined above, wherein the micro-coring punch advances towards the skin and penetrates the skin to a depth of at least 2 millimeters.

[0123] It is a further object of the present invention to provide a device as defined above, wherein the mechanism configured to advance the micro-coring punch towards and penetrate the skin is one of a group of mechanisms consisting of a robotic arm or a screw.

[0124] Another object of the present invention is to provide a method for directional skin tightening of a skin area, comprising: (i) creating a plurality of excised tissue portions in an area of ​​skin tissue; (ii) applying energy to the skin area to contract or expand the skin area in a predetermined direction to effect directional skin tightening in the skin tissue; The object of the present invention is to provide a method comprising the steps of:

[0125] Another object of the present invention is to provide a method as defined above, further comprising the step of applying a stretching tension to said skin area prior to said step of creating a plurality of excised tissue portions.

[0126] Another object of the present invention is to provide a method as defined above, wherein said directional skin tightening is performed in a direction selected from the group consisting of x-direction, y-direction and / or z-direction, and any combination thereof.

[0127] Another object of the present invention is to provide a method as defined above, wherein said step of creating a plurality of excised tissue portions in an area of ​​skin tissue is performed by means selected from the group consisting of mechanical means, application of temperature to heat and expel tissue, application of laser, application of RF, coblation, coagulation, microwave energy, ultrasound, and any other energy, and any combination thereof.

[0128] Another object of the present invention is to provide a method as defined above, wherein said step of applying energy to said skin area to contract or expand said skin area is performed by means selected from the group consisting of mechanical means, temperature application to heat and expel tissue, application of laser, RF, coblation, coagulation, microwave energy, ultrasound, and any other energy application, and any combination thereof.

[0129] Another object of the present invention is to provide a method as defined above, wherein the step of creating a plurality of excised tissue portions in an area of ​​skin tissue is performed by a system comprising at least one robotic arm, said at least one robotic arm comprising at least one skin coring device.

[0130] Another object of the present invention is to provide a method as defined above, wherein said at least one skin coring instrument comprising at least one punch is configured to contact a surface of the skin to generate a hole in the skin tissue by an excised portion of the skin tissue.

[0131] Another object of the invention is to provide a method as defined above, wherein said at least one punch is at least six punches, five of which are arranged in the shape of a pentagon centered on a sixth, central punch.

[0132] Another object of the present invention is to provide a method as defined above, wherein at least a part of said at least one punch is disposable.

[0133] Another object of the invention is to provide a method as defined above, wherein said all of said punches are adapted to penetrate said skin simultaneously or sequentially.

[0134] Another object of the invention is to provide a method as defined above, in which all of said punches are characterized either by a similar cross-sectional area or by substantially different cross-sectional areas.

[0135] Another object of the invention is to provide a method as defined above, wherein said punches are adapted to penetrate to a depth of between 1 mm and 4 mm into said skin.

[0136] Another object of the invention is to provide a method as defined above, in which at least one of said punches is characterized by a radius between 0.15 mm and 1.0 mm.

[0137] Another object of the present invention is to provide a method as defined above, wherein said cross-sectional area is selected from the group consisting of a circle, a rectangle, a triangle, a hexagon, an ellipse, a staggered array, a parallel array, a spiral pattern, a square or rectangular pattern, a radial distribution, and any combination thereof.

[0138] Another object of the invention is to provide a method as defined above, wherein said system further comprises at least one controller adapted to control the positioning of said at least one robotic arm relative to said skin area.

[0139] Another object of the present invention is to provide a method as defined above, wherein said controller comprises at least one engine adapted to control at least one parameter selected from the group consisting of rotation, translation, penetration angle of said at least one robotic arm relative to said skin, penetration depth, coverage, diameter of at least one excised tissue multiplied by number of cores, different areas of said skin to be treated, and any combination thereof.

[0140] Another object of the invention is to provide a method as defined above, wherein said parameters are manually adjusted by an operator or automatically adjusted by said controller.

[0141] Another object of the invention is to provide a method as defined above, in which said parameters are adjusted in real time.

[0142] Another object of the present invention is to provide a method as defined above, wherein the speed of said rotation ranges from 1000 RPM to 7000 RPM.

[0143] Another object of the invention is to provide a method as defined above, wherein the speed of said translation ranges from 0 mm / s to 500 mm / s.

[0144] Another object of the invention is to provide a method as defined above, wherein the translation of the at least one robotic arm relative to the skin varies as the at least one robotic arm approaches the skin.

[0145] Another object of the invention is to provide a method as defined above, wherein said rotation of said at least one robotic arm varies as said at least one robotic arm approaches and penetrates the skin.

[0146] Another object of the invention is to provide a method as defined above, in which at least one punch rotates individually at a predetermined speed and in a predetermined direction.

[0147] Another object of the invention is to provide a method as defined above, in which all of said punches rotate simultaneously.

[0148] Another object of the invention is to provide a method as defined above, in which each punch translates individually.

[0149] Another object of the invention is to provide a method as defined above, in which all of said punches translate simultaneously.

[0150] Another object of the invention is to provide a method as defined above, wherein said controller comprises a stop mechanism adapted to limit the depth to which at least one punch penetrates said skin.

[0151] Another object of the invention is to provide a method as defined above, wherein said penetration angle is substantially perpendicular to said skin.

[0152] Another object of the present invention is to provide a method as defined above, wherein said controller is adapted to define at least one no-fly zone, said no-fly zone being defined as an area within which said system does not apply treatment.

[0153] Another object of the present invention is to provide a method as defined above, wherein said system further delivers an additive to the skin.

[0154] Another object of the present invention is to provide a method as defined above, wherein said additive is selected from the group consisting of: a therapeutic agent, saline growth factor, platelet derived growth factor (PDGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), epidermal growth factor (EGF), and keratinocyte growth factor; one or more stem cells; a steroid, an agent for preventing post-inflammatory skin hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungals; one or more anti-inflammatory agents, or mineralocorticoid agents, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; a foam; or a hydrogel, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, procoagulants, antifibrinolytic agents, one or more procoagulants, one or more anticoagulants, one or more immunomodulators including corticosteroids and non-steroidal immunomodulators, one or more proteins; or one or more vitamins and any combination thereof.

[0155] Another object of the present invention is to provide a method as defined above, wherein said system further comprises at least one imaging subsystem adapted to guide said at least one skin coring instrument.

[0156] Another object of the present invention is to provide a method as defined above, wherein said imaging subsystem comprises at least one selected from the group consisting of at least one camera, subcutaneous imaging such as ultrasound-based imaging, OCT, and any combination thereof.

[0157] Another object of the present invention is to provide a method as defined above, wherein said system further comprises at least one vacuum subsystem adapted to provide suction to remove the excised portion of said skin tissue.

[0158] Another object of the present invention is to provide a method as defined above, wherein said skin may be part of a treatment area selected from the group consisting of forehead, cheeks, jawline, neck, upper arms, stomach, abdomen, face, eyelids, nose, forehead, chin, forehead, lips, nose, neck, thighs, chest, legs, back and any combination thereof.

[0159] Another object of the present invention is to provide a method as defined above used for localized removal of excess dermal tissue for skin tightening, at least partial scar removal, skin rejuvenation, at least partial removal of pigment, at least partial tattoo removal, veins, acne, allodynia, age spots, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigines or keratoses, loss of transparency, loss of elasticity, melasma, photodamage, xerosis, fine lines, wrinkles, paleness, scar contracture, scarring, wrinkles, folds, acne scars, dyschromia, striae, surgical scars, cellulite, tattoo removal, malar lines, facial lines, facial folds, skin aging, skin contraction, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangiomas, papules, port wine stains, rosacea, venules reticulata, or telangiectasias, or any other undesirable skin abnormality and any combination thereof.

[0160] Another object of the present invention is to provide a method as defined above, wherein said system utilizes at least one selected from the group consisting of mechanical visualization, OCT, ultrasound, machine learning algorithms, artificial intelligence, image processing, and any combination thereof to efficiently select preferred locations of the tissue to be treated to improve the outcome of said treatment.

[0161] Another object of the present invention is to provide a method as defined above, wherein the area percentage of the excised tissue portion is between about 5% and about 30% of the skin area.

[0162] Another object of the present invention is to provide a method as defined above, wherein the area percentage of the ablated tissue portion is less than about 10% of the skin area.

[0163] Another object of the invention is to provide a method as defined above, comprising a step of pre-stretching the skin area prior to the step of creating a plurality of excised tissues.

[0164] Another object of the present invention is to provide a directional skin tightening system for a skin area, comprising: (i) a means for creating a plurality of excised tissue portions in an area of ​​skin tissue; (ii) means for applying at least one type of energy to the skin area to contract or expand the skin area in a predetermined direction to effect directional skin tightening in the skin tissue; The object of the present invention is to provide a system comprising:

[0165] Another object of the present invention is to provide a method as defined above, further comprising means for applying a stretching tension to said skin area prior to said step of creating a plurality of excised tissue portions.

[0166] Another object of the present invention is to provide a system as defined above, wherein said directional skin tightening is performed in a direction selected from the group consisting of x-direction, y-direction and / or z-direction, and any combination thereof.

[0167] Another object of the present invention is to provide a system as defined above, wherein said means for creating a plurality of excised tissue portions in an area of ​​skin tissue comprises means selected from the group consisting of mechanical means, temperature application for heating and expelling tissue, laser application, RF, coblation, coagulation, microwave energy, ultrasound, and any other type of energy application, and any combination thereof.

[0168] Another object of the present invention is to provide a system as defined above, wherein said means for applying energy to said skin area to contract or expand said skin area comprises means selected from the group consisting of mechanical means, temperature application to heat and expel tissue, application of laser, RF, coblation, coagulation, microwave energy, ultrasound, and application of any other type of energy, and any combination thereof.

[0169] Another object of the present invention is to provide a system as defined above, wherein the means for creating a plurality of excised tissue portions in an area of ​​skin tissue comprises a system comprising at least one robotic arm, said at least one robotic arm comprising at least one skin coring device.

[0170] Another object of the present invention is to provide a system as defined above, wherein the at least one skin coring device comprises a plurality of punches (or at least one punch) configured to contact the surface of the skin to generate holes in the skin tissue by excised portions of the skin tissue.

[0171] Another object of the invention is to provide a system as defined above, wherein said plurality of punches is at least six punches, five of which are arranged in the shape of a pentagon centered on a sixth, central punch.

[0172] Another object of the present invention is to provide a system as defined above, wherein at least a portion of said plurality of punches are disposable.

[0173] Another object of the invention is to provide a system as defined above, wherein said multiple punches are adapted to penetrate said skin simultaneously or sequentially.

[0174] Another object of the invention is to provide a system as defined above, wherein said punches are characterized either by similar cross-sectional areas or by substantially different cross-sectional areas.

[0175] Another object of the invention is to provide a system as defined above, wherein said punches are adapted to penetrate to a depth of between 1 mm and 4 mm into said skin.

[0176] Another object of the invention is to provide a system as defined above, wherein at least some of said plurality of punches are characterized by a radius between 0.15 mm and 1.0 mm.

[0177] Another object of the present invention is to provide a system as defined above, wherein said cross-sectional area is selected from the group consisting of a circle, a rectangle, a triangle, a hexagon, an ellipse, a staggered array, a parallel array, a spiral pattern, a square or rectangular pattern, a radial distribution, and any combination thereof.

[0178] Another object of the invention is to provide a system as defined above, further comprising at least one controller adapted to control the positioning of said at least one robotic arm relative to said skin area.

[0179] Another object of the present invention is to provide a system as defined above, wherein said controller comprises at least one engine adapted to control at least one parameter selected from the group consisting of rotation, translation, penetration angle of said at least one robotic arm relative to said skin, penetration depth, coverage, diameter of at least one excised tissue multiplied by number of cores, different areas of said skin to be treated, and any combination thereof.

[0180] Another object of the invention is to provide a system as defined above, in which said parameters are manually adjusted by an operator or automatically adjusted by said controller.

[0181] Another object of the invention is to provide a system as defined above, in which said parameters are adjusted in real time.

[0182] Another object of the invention is to provide a system as defined above, in which the speed of said rotation ranges from 1000 RPM to 7000 RPM.

[0183] Another object of the invention is to provide a system as defined above, in which the speed of said translation ranges from 0 mm / s to 500 mm / s.

[0184] Another object of the invention is to provide a system as defined above, wherein the translation of the at least one robotic arm relative to the skin varies as the at least one robotic arm approaches the skin.

[0185] Another object of the invention is to provide a system as defined above, wherein said rotation of said at least one robotic arm varies as it approaches and penetrates the skin.

[0186] Another object of the present invention is to provide a system as defined above, wherein each punch of said plurality of punches rotates individually in a predetermined direction at a predetermined speed.

[0187] Another object of the invention is to provide a system as defined above, in which said punches rotate simultaneously.

[0188] Another object of the present invention is to provide a system as defined above, in which each punch of said plurality of punches translates individually.

[0189] Another object of the invention is to provide a system as defined above, in which said punches translate simultaneously.

[0190] Another object of the invention is to provide a system as defined above, wherein said controller comprises a stop mechanism adapted to limit the depth to which at least some of said plurality of punches penetrate into said skin.

[0191] Another object of the invention is to provide a system as defined above, wherein said penetration angle is substantially perpendicular to said skin.

[0192] Another object of the present invention is to provide a system as defined above, wherein said controller is adapted to define at least one no-fly zone, said no-fly zone being defined as an area within which said system does not apply treatment.

[0193] Another object of the present invention is to provide a system as defined above, which further delivers additives to the skin.

[0194] Another object of the present invention is to provide a system as defined above, wherein said additive is selected from the group consisting of: a therapeutic agent, saline growth factor, platelet derived growth factor (PDGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), epidermal growth factor (EGF), and keratinocyte growth factor; one or more stem cells; a steroid, an agent for preventing post-inflammatory skin hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungals; one or more anti-inflammatory agents, or mineralocorticoid agents, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; a foam; or a hydrogel, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, procoagulants, antifibrinolytic agents, one or more procoagulants, one or more anticoagulants, one or more immunomodulators including corticosteroids and nonsteroidal immunomodulators, one or more proteins; or one or more vitamins and any combination thereof.

[0195] Another object of the present invention is to provide a system as defined above, further comprising at least one imaging subsystem adapted to guide said at least one skin coring instrument.

[0196] Another object of the present invention is to provide a system as defined above, wherein said imaging subsystem comprises at least one selected from the group consisting of at least one camera, subcutaneous imaging such as ultrasound-based imaging, OCT, and any combination thereof.

[0197] Another object of the present invention is to provide a system as defined above, further comprising at least one vacuum subsystem adapted to provide suction to remove the excised portion of said skin tissue.

[0198] Another object of the present invention is to provide a system as defined above, wherein said skin can be part of a treatment area selected from the group consisting of forehead, cheeks, jawline, neck, upper arms, stomach, abdomen, face, eyelids, nose, forehead, chin, forehead, lips, nose, neck, thighs, chest, legs, back and any combination thereof.

[0199] Another object of the present invention is to provide a system as defined above for use in localized removal of excess dermal tissue for skin tightening, at least partial scar removal, skin rejuvenation, at least partial removal of pigment, at least partial tattoo removal, veins, acne, allodynia, age spots, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigines or keratoses, loss of translucency, loss of elasticity, melasma, photodamage, xerosis, fine lines, wrinkles, paleness, scar contracture, scarring, wrinkles, folds, acne scars, dyschromatosis, striae, surgical scars, cellulite, tattoo removal, malar lines, facial lines, facial folds, skin aging, skin contraction, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangiomas, papules, port wine stains, rosacea, venules reticulata, or telangiectasias, or any other undesirable skin abnormality and any combination thereof.

[0200] Another object of the present invention is to provide a system as defined above, which utilizes at least one selected from the group consisting of mechanical visualization, OCT, ultrasound, machine learning algorithms, artificial intelligence, image processing, and any combination thereof to efficiently select preferred locations of the tissue to be treated to enhance the outcome of said treatment.

[0201] Another object of the present invention is to provide a system as defined above, wherein the area percentage of the ablated tissue portion is between about 5% and about 30% of the skin area.

[0202] Another object of the present invention is to provide a system as defined above, in which the area percentage of the ablated tissue is less than about 10% of the skin area.

[0203] Another object of the invention is to provide a system as defined above, which comprises pre-stretching the skin area before creating the plurality of excised tissues.

[0204] Another object of the present invention is to provide a method as defined above, further comprising the step of providing the system with at least one cutting element adapted to fragment said resected tissue to facilitate removal of said resected tissue.

[0205] Another object of the present invention is to provide a method as defined above, further comprising the step of providing the system with at least one cutting element adapted to fragment said resected tissue to facilitate removal of said resected tissue.

[0206] Another object of the present invention is to provide a method as defined above, further comprising the step of providing the system with at least one cutting element adapted to fragment said resected tissue to facilitate removal of said resected tissue.

[0207] Another object of the present invention is to provide a method as defined above, further comprising the step of providing the system with at least one cutting element adapted to fragment said resected tissue to facilitate removal of said resected tissue.

[0208] Another object of the present invention is to provide a method as defined above, further comprising the step of providing the system with at least one cutting element adapted to fragment said resected tissue to facilitate removal of said resected tissue.

[0209] Another object of the present invention is to provide an apparatus as defined above, further comprising at least one cutting element incorporated within said skin coring instrument and adapted to disrupt said excised tissue to facilitate removal of said excised tissue.

[0210] Another object of the present invention is to provide an apparatus as defined above, further comprising at least one cutting element incorporated within said skin coring instrument and adapted to disrupt said excised tissue to facilitate removal of said excised tissue.

[0211] Another object of the present invention is to provide an apparatus as defined above, further comprising at least one cutting element incorporated within said skin coring instrument and adapted to disrupt said excised tissue to facilitate removal of said excised tissue.

[0212] Another object of the present invention is to provide a system as defined above, further comprising at least one cutting element incorporated within said skin coring instrument and adapted to disrupt said excised tissue to facilitate extraction of said excised tissue.

[0213] Another object of the present invention is to provide a method as defined above, wherein said at least one skin coring device is in communication with at least one RF generator adapted to apply RF energy to the skin and tissue for fractional ablation / coagulation of tissue.

[0214] Another object of the present invention is to provide a method as defined above, wherein said application of RF energy is performed simultaneously or sequentially with the coring of said skin.

[0215] Another object of the present invention is to provide a method as defined above, wherein said at least one skin coring device is in communication with at least one pulsed electromagnetic frequency generator.

[0216] Another object of the invention is to provide a method as defined above, wherein said pulsed electromagnetic frequency generator is adapted to apply at least one dynamic magnetic field pulse to said skin.

[0217] Another object of the invention is to provide a method as defined above, wherein said dynamic magnetic field pulses are generated by at least one coil.

[0218] Another object of the present invention is to provide a method as defined above, wherein said at least one skin coring device is at least partially wrapped by at least one coil.

[0219] Another object of the present invention is to provide a method as defined above, wherein said at least one skin coring device is adapted to apply both said electromagnetic pulses and said RF energy simultaneously to said skin.

[0220] Another object of the present invention is to provide a method as defined above, wherein said RF energy is applied to said skin in the form of heat.

[0221] Another object of the present invention is to provide a method for producing a pulsed electromagnetic wave having a pulse width of 100 Hz to 150 Hz, comprising the steps of: (a) a shape of the electromagnetic pulse selected from the group consisting of a square wave, a sine wave, a triangular wave, a sawtooth wave, a ramp wave, a spike wave, or any combination thereof; (b) a magnetic field strength B of each pulse applied by the pulsed electromagnetic wave frequency generator is in the range of about 0 Tesla to about 3 Tesla; (c) a magnetic field strength B of each pulse applied by the pulsed electromagnetic wave frequency generator is in the range of about 0 Gauss to about 40 Gauss; (d) a duration of each pulse applied by the pulsed electromagnetic wave frequency generator is in the range of about 3 milliseconds to about 1000 milliseconds; (e) a frequency F applied by the pulse of the pulsed electromagnetic wave frequency generator is in the range of about 1 Hz to about 40 MHz; (f) the pulsed electromagnetic wave (g) the frequency F applied by the pulses applied by the step of administering pulsed electromagnetic wave therapy to the area is in the range of about 1 Hz to about 1 MHz; (h) the frequency F applied by the electromagnetic field pulses is in the range of 1 Hz to 50 Hz; (i) the frequency of the RF energy is in the range of 200 kHz to 40 MHz; (j) the power P applied by the RF energy pulses is an RMS average power of 1 W to 100 W; and any combination thereof.

[0222] Another object of the invention is to provide a method as defined above, further comprising at least one temperature sensor.

[0223] Another object of the invention is to provide a method as defined above, further comprising a mechanism for skin cooling adapted to regulate the temperature of the skin.

[0224] Another object of the present invention is to provide a method as defined above, wherein the distal end of said at least one skin coring device further comprises at least one selected from the group consisting of at least one impedance, at least one temperature sensor, and any combination thereof.

[0225] Another object of the present invention is to provide a method as defined above, wherein said at least one selected from the group consisting of at least one impedance, at least one temperature sensor, and any combination thereof, is adapted to provide an indication as to the depth of penetration of each of said at least one skin coring device.

[0226] Another object of the present invention is to provide a method as defined above, wherein said at least one skin coring device further comprises at least one needle adapted to inject at least one treatment substance into the treatment area.

[0227] Another object of the present invention is to provide a method as defined above, wherein said at least one therapeutic substance is selected from the group consisting of hyaluronic acid, Botox, collagen, stem cells and any combination thereof.

[0228] Another object of the present invention is to provide a segmented coring device for directional skin tightening, comprising: (i) a means for creating a plurality of excised tissue portions in an area of ​​skin tissue; (ii) means for securing to the area of ​​skin a stretching / compressing device having at least two parts adapted to contract or expand said area of ​​skin in at least one predetermined direction; The aim of the present invention is to provide a device that supports collagen proliferation and provides directional skin tightening in said skin tissue.

[0229] It is another object of the present invention to provide a device as defined above, wherein said extension / compression instrument comprises a long portion and a short portion, said short portion comprising at least one buckle-like element having at least one slotted hole, and further wherein said long portion is adapted to be in physical communication with said short portion by being threaded through said at least one slotted hole and secured to said short portion.

[0230] Another object of the invention is to provide a device as defined above, wherein said long portion comprises at least one adhesive layer adapted to ensure attachment of said short portion to said long portion.

[0231] Another object of the invention is to provide a device as defined above, wherein said short portion comprises at least one adhesive layer adapted to ensure attachment between said short portion and said long portion.

[0232] Another object of the invention is to provide a device as defined above, wherein said long portion comprises a Velcro fastener adapted to secure the attachment of said short portion to said long portion.

[0233] Another object of the invention is to provide a device as defined above, in which said short portion comprises a Velcro fastener adapted to secure the attachment of said short portion to said long portion.

[0234] Another object of the present invention is to provide a device as defined above, wherein said stretching / compression device comprises at least one occlusive layer adapted to control wettability and / or promote wound healing of said skin.

[0235] Another object of the invention is to provide a device as defined above, wherein said expansion / compression device comprises at least one absorbent layer adapted to absorb wound exudate.

[0236] Another object of the present invention is to provide a device as defined above, wherein said stretching / compression device is provided in skin tone or is transparent or translucent.

[0237] Another object of the present invention is to provide a device as defined above, wherein said step of creating a plurality of excised tissue portions in an area of ​​skin tissue is performed by means selected from the group consisting of mechanical means, application of temperature to heat and expel tissue, application of laser, application of pulsed electromagnetic fields, RF, coblation, coagulation, microwave energy, ultrasound, and any other type of energy, and any combination thereof.

[0238] Another object of the present invention is to provide an apparatus as defined above, wherein the step of creating a plurality of excised tissue portions in an area of ​​skin tissue is performed by a system comprising at least one robotic arm, said at least one robotic arm comprising at least one skin coring device.

[0239] Another object of the present invention is to provide an apparatus as defined above, wherein said at least one skin coring device comprises at least one selected from the group consisting of at least one needle, at least one punch, and any combination thereof, and said at least one skin coring device is configured to contact a surface of the skin to create a hole in the skin tissue by an excised portion of the skin tissue.

[0240] Another object of the present invention is to provide a device as defined above, wherein said at least one skin coring device is at least six punches, five of which are arranged in the shape of a pentagon centered on a sixth central punch.

[0241] Another object of the invention is to provide a device as defined above, in which at least a part of said at least one punch is disposable.

[0242] Another object of the present invention is to provide an apparatus as defined above, wherein at least two of said at least one skin coring instruments are adapted to penetrate said skin simultaneously or sequentially.

[0243] Another object of the present invention is to provide an apparatus as defined above, wherein at least two of said at least one skin coring device are characterized by either a similar cross-sectional area or substantially different cross-sectional areas.

[0244] Another object of the invention is to provide an apparatus as defined above, wherein said at least one skin coring instrument is adapted to penetrate said skin to a depth of between 1 mm and 4 mm.

[0245] Another object of the invention is to provide a device as defined above, wherein said at least one skin coring instrument is characterized by a radius between 0.15 mm and 1.0 mm.

[0246] Another object of the present invention is to provide a device as defined above, wherein said cross-sectional area is selected from the group consisting of a circle, a rectangle, a triangle, a hexagon, an ellipse, a staggered array, a parallel array, a spiral pattern, a square or rectangular pattern, a radial distribution, and any combination thereof.

[0247] Another object of the invention is to provide a device as defined above, wherein said system further comprises at least one controller adapted to control the positioning of said at least one robotic arm relative to said skin area.

[0248] Another object of the present invention is to provide a device as defined above, wherein said controller comprises at least one engine adapted to control at least one parameter selected from the group consisting of rotation, translation, penetration angle of said at least one robotic arm relative to said skin, penetration depth, coverage, diameter of at least one excised tissue multiplied by number of cores, different areas of said skin to be treated, and any combination thereof.

[0249] Another object of the invention is to provide a device as defined above, in which said parameters are manually adjusted by an operator or automatically adjusted by said controller.

[0250] Another object of the invention is to provide a device as defined above, in which said parameters are adjusted in real time.

[0251] Another object of the invention is to provide a device as defined above, in which the speed of said rotation ranges from 1000 RPM to 7000 RPM.

[0252] Another object of the invention is to provide a device as defined above, in which the speed of said translation ranges from 0 mm / s to 500 mm / s.

[0253] Another object of the invention is to provide a device as defined above, wherein the translation of the at least one robotic arm relative to the skin varies as the at least one robotic arm approaches the skin.

[0254] Another object of the invention is to provide a device as defined above, wherein said rotation of said at least one robotic arm varies as said at least one robotic arm approaches and penetrates the skin.

[0255] It is another object of the present invention to provide an apparatus as defined above, wherein each of said at least one skin coring device rotates individually in a predetermined direction at a predetermined speed.

[0256] Another object of the present invention is to provide an apparatus as defined above, wherein at least two of said skin coring devices rotate simultaneously.

[0257] It is another object of the present invention to provide an apparatus as defined above, wherein each of said at least one skin coring device translates independently.

[0258] It is another object of the present invention to provide an apparatus as defined above, wherein at least two of said at least one skin coring device translate simultaneously.

[0259] It is another object of the present invention to provide an apparatus as defined above in which the distance between each pair of adjacent skin coring devices is variable and adjustable before or during treatment.

[0260] Another object of the present invention is to provide a device as defined above, wherein said controller comprises a stop mechanism adapted to limit the depth to which at least a portion of said at least one skin coring device penetrates into said skin.

[0261] Another object of the invention is to provide a device as defined above, wherein said penetration angle is substantially perpendicular to said skin.

[0262] Another object of the present invention is to provide a device as defined above, wherein said controller is adapted to define at least one no-fry zone, said no-fry zone being defined as an area within which said system does not apply treatment.

[0263] Another object of the present invention is to provide a skin coring device comprising: a micro-coring punch including at least five micro-coring needles arranged in a predetermined pattern centered around a sixth micro-coring needle; a mechanism configured to rotate each of the micro-coring needles about at least one axis of symmetry of each needle, wherein the rotation of each of the micro-coring needles is synchronized with the rotation of the remaining micro-coring needles; a mechanism configured to step a micro-coring punch toward the skin and penetrate the skin to a depth of at least 2 millimeters; a mechanism configured to step the micro-coring punch and position the micro-coring punch such that at least one element selected from the group consisting of a vertex, a facet, and combinations thereof of the stepped micro-coring punch hexagon intersects with at least one element selected from the group consisting of a vertex, a facet, and combinations thereof of the previous micro-coring punch hexagon; The object of the present invention is to provide an apparatus as defined above, comprising:

[0264] Another object of the present invention is to provide an apparatus as defined above, wherein the micro-coring punch is mounted on a computer-controlled robotic arm capable of moving in six or more axes (degrees of freedom).

[0265] Another object of the present invention is to provide an apparatus as defined above, in which a computer-controlled robotic arm manipulates a micro-coring punch containing five micro-coring needles.

[0266] Another object of the present invention is to provide an apparatus as defined above, further comprising a video camera configured to provide visual feedback of at least the micro-coring punch and the skin, and a closed-loop force sensor for determining when the punch breaks the skin.

[0267] Another object of the invention is to provide a device as defined above, in which the five micro-coring needles are at the vertices of a pentagonal pattern.

[0268] Another object of the invention is to provide a device as defined above, in which the area between the two intersecting facets of the first hexagon and the two facets of the stepped hexagon forms a rhombus.

[0269] Another object of the invention is to provide a device as defined above, wherein the diamond shape comprises at least two micro-coring needles positioned at opposite apexes of the diamond shape.

[0270] Another object of the invention is to provide a device as defined above, in which at least one vortex of the stepped hexagon is located on an inscribed circle having a diameter equal to half the diameter of the hexagon.

[0271] Another object of the present invention is to provide an apparatus as defined above, in which the rotation of each of the micro-coring needles is synchronized with the rotation of the remaining micro-coring needles.

[0272] It is another object of the present invention to provide an apparatus as defined above, wherein the mechanism configured to synchronize the rotation of each of the micro-coring needles with the rotation of the remaining micro-coring needles is one of the group of mechanisms consisting of gears or friction belts.

[0273] Another object of the present invention is to provide a device as defined above, in which the microcoring needles advance towards the skin and penetrate to a depth of at least 2 millimeters of the skin.

[0274] Another object of the present invention is to provide a device as defined above, wherein the mechanism configured to advance the micro-coring needles towards and through the skin is one of the group of mechanisms consisting of a robotic arm or a screw, such advancement being achieved, for example, by a conveyor such as a belt.

[0275] Another object of the present invention is to provide a device as defined above, wherein said system further applies an additive to the skin.

[0276] Another object of the present invention is to provide a device as defined above, wherein said additive is selected from the group consisting of: a therapeutic agent, saline growth factor, platelet derived growth factor (PDGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), epidermal growth factor (EGF), and keratinocyte growth factor; one or more stem cells; a steroid, an agent to prevent post-inflammatory skin hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungals; one or more anti-inflammatory agents, or mineralocorticoid agents, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; a foam; or a hydrogel, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, procoagulants, antifibrinolytic agents, one or more procoagulants, one or more anticoagulants, one or more immunomodulatory agents including corticosteroids and non-steroidal immunomodulatory agents, one or more proteins; or one or more vitamins and any combination thereof.

[0277] Another object of the present invention is to provide an apparatus as defined above, wherein said system further comprises at least one imaging subsystem adapted to guide said at least one skin coring instrument.

[0278] Another object of the present invention is to provide a device as defined above, wherein said imaging subsystem comprises at least one selected from the group consisting of at least one camera, subcutaneous imaging such as ultrasound-based imaging, OCT, and any combination thereof.

[0279] Another object of the present invention is to provide a device as defined above, wherein said system further comprises at least one vacuum subsystem adapted to provide suction to remove the excised portion of said skin tissue.

[0280] Another object of the present invention is to provide a device as defined above, wherein said skin may be part of a treatment area selected from the group consisting of forehead, cheeks, jawline, neck, upper arms, stomach, abdomen, face, eyelids, nose, forehead, chin, forehead, lips, nose, neck, thighs, chest, legs, back and any combination thereof.

[0281] Another object of the present invention is to provide a device as defined above for use in localized removal of excess dermal tissue for skin tightening, at least partial scar removal, skin rejuvenation, at least partial removal of pigment, at least partial tattoo removal, veins, acne, allodynia, age spots, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigines or keratoses, loss of translucency, loss of elasticity, melasma, photodamage, xerosis, fine lines, wrinkles, paleness, scar contracture, scarring, wrinkles, folds, acne scars, dyschromia, striae, surgical scars, cellulite, tattoo removal, malar lines, facial lines, facial folds, skin aging, skin contraction, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangiomas, papules, port wine stains, rosacea, venules reticulata, or telangiectasias, or any other undesirable skin abnormality and any combination thereof.

[0282] Another object of the present invention is to provide a device as defined above, which utilizes at least one selected from the group consisting of mechanical visualization, OCT, ultrasound, machine learning algorithms, artificial intelligence, image processing, and any combination thereof to efficiently select preferred locations of the tissue to be treated to enhance the outcome of said treatment.

[0283] Another object of the present invention is to provide a device as defined above, wherein the area percentage of the ablated tissue portion is between about 5% and about 30% of the skin area.

[0284] Another object of the present invention is to provide a device as defined above, in which the area percentage of the ablated tissue is less than about 10% of the skin area.

[0285] Another object of the present invention is to provide a device as defined above, further comprising at least one cutting element adapted to disrupt said resected tissue to facilitate its removal.

[0286] Another object of the present invention is to provide an apparatus as defined above, wherein said at least one skin coring instrument is in communication with at least one RF generator adapted to apply RF energy to the skin and tissue for fractional ablation / coagulation of tissue.

[0287] Another object of the invention is to provide a device as defined above, wherein said application of RF energy is performed simultaneously or sequentially with the coring of said skin.

[0288] Another object of the present invention is to provide an apparatus as defined above, wherein said at least one skin coring device is in communication with at least one pulsed electromagnetic frequency generator.

[0289] Another object of the invention is to provide a device as defined above, wherein said pulsed electromagnetic frequency generator is adapted to apply at least one dynamic magnetic field pulse to said skin.

[0290] Another object of the invention is to provide a device as defined above, wherein said dynamic magnetic field pulses are generated by at least one coil.

[0291] Another object of the present invention is to provide an apparatus as defined above, wherein said at least one skin coring device is at least partially wrapped by at least one coil.

[0292] Another object of the present invention is to provide an apparatus as defined above, wherein said at least one skin coring device is adapted to apply both said electromagnetic pulses and said RF energy simultaneously to said skin.

[0293] Another object of the present invention is to provide a device as defined above, wherein said RF energy is applied to said skin in the form of heat.

[0294] Another object of the present invention is to provide a method for producing a pulsed electromagnetic wave frequency generator, comprising: (a) a shape of the electromagnetic pulse selected from the group consisting of a square wave, a sine wave, a triangular wave, a sawtooth wave, a ramp wave, a spike wave, or any combination thereof; (b) a magnetic field strength B of each pulse applied by the pulsed electromagnetic wave frequency generator is in the range of about 0 Tesla to about 3 Tesla; (c) a magnetic field strength B of each pulse applied by the pulsed electromagnetic wave frequency generator is in the range of about 0 Gauss to about 40 Gauss; (d) a duration of each pulse applied by the pulsed electromagnetic wave frequency generator is in the range of about 3 milliseconds to about 1000 milliseconds; (e) a frequency F applied by the pulse of the pulsed electromagnetic wave frequency generator is in the range of about 1 Hz to about 40 MHz; (f) the pulsed electromagnetic wave frequency (g) the frequency F applied by the pulses applied by said step of administering pulsed electromagnetic wave therapy to said area is in the range of about 1 Hz to about 40 MHz; (h) the frequency F applied by the electromagnetic field pulses is in the range of 1 Hz to 50 Hz; (i) the frequency of the RF energy pulses is in the range of 200 kHz to 10 MHz; (j) the power P applied by the RF energy pulses is an RMS average power of 1 W to 100 W; and any combination thereof.

[0295] Another object of the invention is to provide a device as defined above, further comprising at least one temperature sensor.

[0296] Another object of the invention is to provide a device as defined above, further comprising a mechanism for skin cooling adapted to regulate the temperature of the skin.

[0297] Another object of the present invention is to provide a device as defined above, wherein the distal end of said at least one skin coring device further comprises at least one selected from the group consisting of at least one impedance, at least one temperature sensor, and any combination thereof.

[0298] Another object of the present invention is to provide a device as defined above, wherein said at least one selected from the group consisting of at least one impedance, at least one temperature sensor, and any combination thereof, is adapted to provide an indication as to the depth of penetration of each of said at least one skin coring device.

[0299] Another object of the present invention is to provide a device as defined above, wherein said at least one skin coring instrument further comprises at least one needle adapted to inject at least one treatment substance into the treatment area.

[0300] Another object of the present invention is to provide a device as defined above, wherein said at least one therapeutic substance is selected from the group consisting of hyaluronic acid, Botox, collagen, stem cells and any combination thereof. [Brief description of the drawings]

[0301] [Figure 1] FIG. 2 illustrates the normal operation of the device of the present invention. [Diagram 2] FIG. 1 illustrates the dermal micro-coring process using a single punch. [Figure 3A] FIG. 1 illustrates two possible punch rotation drive methods: belt drive and friction drive. [Figure 3B] FIG. 1 illustrates two possible punch rotation drive methods: belt drive and friction drive. [Figure 3C] FIG. 1 illustrates two possible punch rotation drive methods: belt drive and friction drive. [Figure 3D]FIG. 1 illustrates two possible punch rotation drive methods: belt drive and friction drive. [Figure 3E] FIG. 1 illustrates two possible punch rotation drive methods: belt drive and friction drive. [Figure 4] FIG. 13 shows how the dissected skin cores from each punch are sucked up by a vacuum. [Figure 5A] FIG. 1 illustrates one arm utilizing one or more punches embodied within the system. [Figure 5B] FIG. 1 illustrates one arm utilizing one or more punches embodied within the system. [Figure 6] 1 is a top view of a punch, which is depicted as a coaxial punch. [Figure 7] FIG. 13 illustrates one tool design configured to distribute punches to allow for overlapping patterns. [Figure 8] FIG. 13 illustrates one tool design configured to distribute punches to allow for overlapping patterns. [Figure 9] FIG. 13 illustrates one tool design configured to distribute punches to allow for overlapping patterns. [Figure 10A] FIG. 1 illustrates one embodiment of a stretch / compression device. [Figure 10B] FIG. 1 illustrates one embodiment of a stretch / compression device. [Figure 11] FIG. 1 shows the short side of this embodiment of the tension / compression device. [Figure 12] FIG. 1 shows the short side of this embodiment of the tension / compression device. [Figure 13] FIG. 1 shows the long side of this embodiment of the tension / compression device. [Figure 14] FIG. 1 shows the long side of this embodiment of the tension / compression device. [Figure 15A] 13A-13C illustrate another embodiment of the directional tightening method and apparatus of the present invention. [Figure 15B] 13A-13C illustrate another embodiment of the directional tightening method and apparatus of the present invention. [Figure 15C] 13A-13C illustrate another embodiment of the directional tightening method and apparatus of the present invention. [Figure 15D] 13A-13C illustrate another embodiment of the directional tightening method and apparatus of the present invention. [Figure 16] 13A-13C illustrate another embodiment of the directional tightening method and apparatus of the present invention. [Figure 17] FIG. 1 shows histological analysis of tissue cross sections 0, 2, and 5 weeks after fractional coring (tissue removal) treatment. [Figure 18] 1A and 1B are side and longitudinal cross-sectional views of a biological unit removal tool having inner-claw-like movable retention members (retainers or retainer elements) in a retracted or undeployed state. [Figure 19] 18C are side and longitudinal cross-sectional views of the biological unit removal tool of FIGS. 18A and 18B in a holding state. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0302] The present invention relates to a method and device for tightening skin and / or reducing skin laxity by selectively opening or closing multiple small wounds formed by incision or excision of tissue.For example, tissue ablation can be performed by fractional ablation of the epidermal and / or dermal layers of skin with at least one hollow coring needle (or punch), by fractional laser ablation, by fractional radio frequency (also called RFR) ablation, and / or by fractional ultrasonic ablation (using ultrasound).Various methods and devices have been proposed for closing small wounds, including adjustable or smart dressings that allow titration of the tightening effect after application to the patient's skin.

[0303] The device of the present invention ablates a pattern of small dermal cores with the desired density and orientation. The remaining holes in the skin are then closed unidirectionally using manual compression methods such as compression tape or adhesives.

[0304] According to one embodiment of the present invention, the device of the present invention is designed to remove micro-cores of skin in a segmented manner for different indications (eg, skin resurfacing / wrinkling / lifting, etc.).

[0305] According to one embodiment of the present invention, the coring mechanism is a disposable cartridge consisting of at least one (preferably six) hollow needles (or punches) with a diameter of up to 0.75 mm, which are inserted into the skin while rotating at a speed of about 7000 RPM with a maximum penetration depth of up to 3.5 mm to remove up to 15% of the skin in the treatment area. The present invention further relates to a method and device for skin treatment. More specifically, the present invention relates to a method and device for skin coring and tightening, which benefits from achieving skin repair or tightening by supporting (e.g., promoting) collagen proliferation in a predetermined direction and performing directional skin tightening in said skin tissue. The device may be utilized in a wide variety of fields, such as, for example, skin loosening, skin resurfacing, treatment of cheek wrinkles, treatment of wrinkles, treatment of folds, removal of acne scars, treatment of pigmentation disorders, treatment of striae, removal of surgical scars, treatment of cellulite, removal of tattoos, and any combination thereof.

[0306] In certain embodiments, the present invention provides one or more of the following advantages. First, the methods and instruments herein allow visualization of results in real time during the course of treatment. It can be envisioned to ask the patient for feedback in real time during treatment and adjust the tightening to the patient's preferences. Second, the methods and instruments herein are adjustable, thereby allowing titration of the tightening after surgical hole or slit formation. For example, the adjustable or smart dressings described herein allow adjustment of the tightening strength, direction, and spatial distribution after the dressing is applied or affixed to the patient's skin. In another example, titratable tightening can be achieved by selectively closing or opening a subset of the slits or holes created in the array. Third, the methods and instruments herein require less skill than a surgeon. Rather than requiring an inpatient surgical environment, treatment of the patient in an outpatient setting can be envisioned. Fourth, the methods and devices herein constitute minimally invasive techniques that may result in more predictable outcomes and / or risk factors than more invasive techniques (e.g., plastic surgery) or non-invasive energy-based techniques (e.g., laser, coblation, coagulation, microwave energy, radiofrequency, or ultrasound). Fifth, the methods and devices herein may allow for a less discriminatory method of treating the skin by forming holes or slits, because the methods and devices of the present invention allow for more discriminatory control over the closure of such holes or slits. Sixth, the methods and devices herein may close the holes or slits quickly after treating the skin (e.g., within a few seconds after treating the skin, such as within 10 seconds), thereby minimizing the extent of bleeding and / or clotting within the holes or slits.Finally, the methods and devices herein may be useful for maximizing the tightening effect while minimizing healing time by optimizing tightening (e.g., by controlling the degree of skin folding as described herein, e.g., by increasing the degree of skin folding for some applications or skin areas and decreasing the degree of skin folding for other applications or skin areas). definition

[0307] The term "about" hereinafter refers to + / - 25% of any recited value.

[0308] The term "overlap" hereinafter refers to apexes, facets, cross-sectional areas, and any combination thereof.

[0309] The term "optical coherence tomography (OCT)" refers hereinafter to non-invasive imaging. In other words, OCT is an imaging technique that uses low-coherence light to capture two- and three-dimensional images with micrometer resolution from within light-scattering media (e.g., biological tissue). It is used in medical imaging and industrial non-destructive testing (NDT). Optical coherence tomography is based on low-coherence interferometry, typically using near-infrared light. By using light with a relatively long wavelength, the light can penetrate into the scattering medium. Confocal microscopy, another optical technique, typically does not penetrate as deeply into the sample, but has a higher resolution.

[0310] The term "mechanical visualization" hereinafter refers to imaging the underside of the skin / tissue in the treatment area using either ultrasound or OCT. Such mechanical visualization is used to efficiently select the preferred location of the tissue to be treated to improve the outcome of said treatment. It is noted that according to the present invention, the term "mechanical visualization" also includes a camera for imaging the surface of the skin / tissue in the treatment area.

[0311] The term "incised" tissue portion or "incision" hereinafter refers to the cutting, peeling, or ablation of tissue, including tissue portions in a skin region, or the act of cutting, peeling, destroying, or ablating tissue, skin region, or one or more tissue portions. For example, incision includes any cutting, peeling, or ablation into tissue that can destroy the tissue or a portion thereof, thereby creating one or more holes or slits in the skin region. Exemplary methods of forming incised tissue portions or incisions include the use of one or more blades, one or more solid needles, split laser ablation, split radio frequency ablation, coblation, coagulation, microwave energy, and / or split ultrasonic ablation, any useful tool for forming incisions, or any method and device described herein.

[0312] The term "excised" tissue portion or "excision" hereinafter refers to removed tissue, including tissue portions from a skin region, or the act of removing tissue or one or more tissue portions from a skin region. Excision usually refers to "surgically removing". The term is often used in reference to removing a mass, and excision means that tissue is removed using a scalpel, laser, coblation, coagulation, ablation, ultrasound, microwave energy, RF, application of heat (to vaporize a skin portion), a mechanical applicator that "pierces" the skin while suction is applied (during or after piercing) to remove the excised skin portion, or any other device. For example, excision includes any removed tissue or tissue portion from a skin region, which can form an excised tissue portion having a specific geometric shape (e.g., cylindrical, rectangular, triangular, etc., or any shape) and create one or more holes (i.e., negative spaces created by the removal of tissue) in the skin region. Exemplary methods of forming excised tissue portions or excisions include the use of one or more hollow needles (optionally including one or more notches, extensions, protrusions, and / or barbs), one or more micro-augers, one or more micro-abraders, any ablation means that may be used for incision and excision (including ablation lasers, etc.), any useful tool for forming excisions, or any of the methods and devices described herein.

[0313] The term "application of a compressive force" hereinafter refers to a physical change in the compressed tape (as disclosed below), where the applied force is a compressive force that compresses the tape.

[0314] The term "application of an expansion force" hereinafter refers to a physical change in the compressed tape (as disclosed below), where the applied force is an extensional force that expands the tape.

[0315] The present invention features methods and devices for unidirectional tightening of skin after coring of the skin (i.e., having one or more incisions or tissue portions excised). In particular, an exemplary device involves selectively opening or closing holes and / or slits using compression tape.

[0316] The instruments of the present invention are designed using advanced robotics, machine vision, and software engineering to enhance the quality and productivity of skin laxity reduction procedures.

[0317] The device performs a dermal microcoring approach to skin tightening. The device ablates a predetermined pattern of small dermal cores with the desired density and orientation. The remaining holes in the skin are then closed unidirectionally using manual compression methods such as compression tape or adhesives.

[0318] According to one embodiment of the present invention, the treatment parameters (ie, desired density, depth, diameter of the core, etc.) are automatically adjusted for the patient being treated.

[0319] According to one embodiment, the density of the coring is between 5% and 20% of the selected treatment area. It should be noted that according to another embodiment, the coverage (i.e., the diameter of the holes multiplied by the number of holes) is between 5% and 30% of the selected treatment area.

[0320] The device may include the following elements: (1) At least one robotic arm and a controller that controls the positioning of the arm relative to the skin area to be treated. (2) Skin coring equipment and controls. (3) An RTC (real-time controller) unit that includes at least one engine (e.g., a motor or robot servo motor) that controls the rotation, translation, and orientation of the robotic arm relative to the skin area to be treated. (4) An imaging subsystem to analyze the treatment area and guide the coring equipment. (5) A vacuum subsystem that provides suction to remove the excised tissue from the skin after incision. Alternatively, a retainer is used to hold the excised tissue, making the vacuum subsystem unnecessary. Thus, a vacuum is avoided and made unnecessary by such an embodiment. (6) A stretching / compression device that allows for skin compression (e.g., compression tape).

[0321] The skin coring device includes a coring punch (e.g., a microneedle), i.e., a single or multiple punch array for simultaneously or sequentially coring the skin. It is noted that the coring punch may be at least partially disposable.

[0322] According to one embodiment of the present invention, the coring device is a mechanical device that allows for the removal of small (0.4 mm to 1.0 mm) circular skin cores. According to another embodiment of the present invention, any cross-section (other than circular) is within the scope of the present invention. For example, circular, rectangular, triangular, hexagonal, elliptical, staggered, parallel, spiral, square or rectangular patterns, radial distribution, and any combination thereof are also within the scope of the present invention.

[0323] According to one embodiment, the coring instrument has 1-7 rotating (100-7000 RPM) coring punches that can be set to penetrate the skin surface and core to a depth of 1mm-4mm. Suction is applied to remove the core from the skin after incision. The coring punches are disposable and a new one is used for each subject.

[0324] The coring element (e.g., microneedle) has at least one sharp dermal punch (e.g., radius 0.25 mm to 2.0 mm) for coring tissue.

[0325] According to one embodiment, the dermal punch has a stop mechanism (stopper) to limit the coring depth. Typical coring depths can be configured from 1 mm to 6 mm (more specifically 1 mm to 4 mm) in steps of 0.5 mm.

[0326] According to one embodiment, the coring depth resolution is + / - 0.1 mm.

[0327] According to one embodiment, each individual punch is configured to rotate at between 1000 RPM and 7000 RPM.

[0328] According to one embodiment, each individual punch can translate into the skin at a maximum of 500 mm / sec, preferably with a translation speed of less than 300 mm / sec.

[0329] According to one embodiment, each individual punch is configured to rotate at a rate of less than 30 degrees per second.

[0330] According to one embodiment, the puncture angle is perpendicular (+ / - 10 degrees) to the skin.

[0331] According to one embodiment, the mechanical extraction rate is greater than or equal to 1 cycle per second.

[0332] According to one embodiment, the punch is flushed with saline. It is noted that saline can be used through the punch not only to flush the punch between one coring step but also to reduce friction between the cored tissue and the interior portion of the punch during core ejection.

[0333] The imaging subsystem includes illumination means (eg, emitters such as LEDs) for illuminating the field of view of the imaging subsystem and for maintaining low latency exposure times for the cameras of the imaging subsystem.

[0334] The wavelength of the LED is longer than 600nm (warm white) to allow enough light to be reflected from the skin to the camera. Shorter wavelengths tend to be more absorbed by human skin, causing a darker image.

[0335] The treatment area can be any of the body regions, for example, the face, torso, extremities, such as the forehead, cheeks, jaw line, nose, forehead, neck, upper arms, thighs, abdomen, and stomach. According to another embodiment, the device of the present invention can be used for the localized removal of excess dermal tissue for skin tightening, at least partial scar removal, and the like.

[0336] After the coring process, the skin is pulled together by a stretching / compression instrument (as described below) to promote healing of each stretched / compressed tissue core. According to one embodiment, the stretching / compression instrument is adhesive based (e.g., surgical wound closure tape or glue). It is noted that the operator can compress the skin in different directions.

[0337] According to one embodiment of the present invention, in order to effectively stretch the skin, the tension of the tension / compression device is 20 N / mm 2 ~40N / mm 2 The tension must be due to a tensile force of

[0338] It should be noted that according to one embodiment of the present invention, the operator may specify at least one of the following in the treatment plan: Enter patient information into the database Assigning a surgical area and a no-fly zone where no treatment is applied to said area of ​​skin tissue - Allocate areas with different densities Assign different hole patterns to areas ·Assign punch depth

[0339] According to another embodiment of the invention, the treatment parameters are adjustable in real time during treatment, either manually by the operator or automatically by the system.

[0340] Reference is now made to FIG. 1, which illustrates the normal operation of the device of the present invention.

[0341] The first optional step, step 100, is to outline the skin treatment area using a surgical pen and / or adhesive biocompatible fiducial marker visual identifiers.

[0342] An image of the treatment area with surgical lines and fiducial markers is sufficient for the treatment planning software to automatically recognize and reconstruct the treatment zone in the 3D software environment. Within the treatment planning software, the operator selects the desired area with a skin removal density of 5%-30% and a skin tightening direction. Thus, once the treatment area is contoured, the treatment plan is finalized (as disclosed below) and loaded into the system.

[0343] It should be noted that it is optional to administer local anesthesia to the patient to avoid pain during the procedure.

[0344] In the case of treating wrinkled skin, the operator may stretch the treatment area by applying an adhesive stretch tape. The adhesive tape (e.g. Tegaderm) tensions the skin by pulling it apart in a preferred direction. It is important to note that it is important to stretch the skin first and only afterwards to excise the tissue parts. Otherwise, due to its flexibility, the skin may get trapped in the inner area within the perforation means (punch and / or needle). Thus, according to one embodiment, the method of directional skin tightening by fractional treatment is: (i) creating a plurality of excised tissue portions in an area of ​​skin tissue; (ii) securing at least a portion of a stretching / compression device having at least two portions (e.g., a Tegaderm adhesive tape) to the area of ​​skin, the stretching / compression device being adapted to contract or expand the area of ​​skin in at least one predetermined direction; (iii) applying tension between the two portions to support collagen growth and effect directional skin tightening in the region of skin tissue; This is carried out by.

[0345] As disclosed above, in some cases (e.g., in the case of loose skin), the step of fixing the stretching / compression device to the area of ​​skin and applying tension (either stretching or compressing) to the skin is performed before the step of creating multiple excised tissue portions in an area of ​​skin tissue, in order to prevent the loose skin from becoming trapped inside the perforation means (punch and / or needle).

[0346] According to another embodiment, a stretching / compression device is first stretched or compressed and only afterwards a second portion of said stretching / compression device is secured to a different area of ​​said skin.

[0347] According to another embodiment, a second portion of the stretching / compressing device is secured to a different area of ​​the skin.

[0348] According to another embodiment, the step of applying tension between the two parts further comprises the step of fixing a second part of the stretching / compression instrument to the skin and pulling one part relative to the other. As mentioned above, it is within the scope of the present invention that the two parts of the stretching / compression instrument are first fixed to the skin and stretched, and only thereafter the perforating means (punch or needle) creates a plurality of excised tissue parts.

[0349] It should be noted that even if the operator first applies tension between the two parts of the stretching / compression instrument and only thereafter (while tension is applied to the skin) creates multiple excised tissue portions in an area of ​​skin tissue, the operator may need to apply additional tension between the two parts of the stretching / compression instrument after the excised tissue portions have been created.

[0350] According to another embodiment of the invention, said tension (stretching or compression) may be applied simultaneously with the excision of the skin portion by said perforation means (punch and / or needle).

[0351] The next step, step 101, is to place a disposable punch (and / or needle) onto the instrument. The desired punch (and / or needle) is selected for reservation. The desired density and penetration depth.

[0352] The punches and / or needles are sharp, hollow, and have diameters ranging from 0.4mm to 4.0mm. Larger holes may increase the rate of treatment, but may not be suitable for all skin types and body areas.

[0353] Optionally, stops are installed to limit the maximum coring depth to 1 mm to 4 mm.

[0354] Next, in step 102, the system is aligned with the area of ​​skin to be treated. The skin is then ablated with multiple + / - 0.4mm to 4mm (diameter) punches (or needles).

[0355] According to one embodiment, coring is performed by a rotational movement of the punch (or needle) while it is in contact with the skin. Alternatively, coring is performed by a rotational and translational movement of the punch (or needle).

[0356] Thereafter, or simultaneously with the coring, the excised tissue is removed by vacuum. It should be noted that the system may utilize a perforation means that expels the skin plug ("skin plug") simultaneously with the perforation, and thus no vacuum means are required. In that case, at least one holding element incorporated in the perforation means (punch) is configured to hold the excised tissue (similar to forceps), making the vacuum subsystem unnecessary. Thus, simultaneously with the perforation of the perforation means (punch) made on the skin, the holding element accumulates and holds the excised skin plug (tissue). Thus, the need to perform suction is eliminated, since the main principle of suction is to expel the excised skin plug (tissue). In particular, the at least one holding device may be implemented as a forceps-like instrument configured to apply pressure to hold the tissue.

[0357] An exemplary embodiment of a retention element is shown in Figures 18A and 18B, which are side and longitudinal cross-sectional views, respectively, of a biological unit removal tool having a movable inner claw-like retention member in a retracted or undeployed state. Figures 19A and 19B show the removal tool in a retained or deployed state. Figures 18A, 18B, 19A, and 19D show an example described in U.S. Patent No. 8,696,686, issued April 15, 2014, the entire contents of which, including the apparatus and methods disclosed therein, are incorporated herein by reference. The exemplary removal tool 640 of Figures 18A, 18B, 19A, and 19B has an outer tube or outer member 642 defining a lumen and an inner tube or inner member 644 having a plurality of movable members or deformable claws 646 attached to the inner tube. In the retracted position, the deformable claws 646 are flush with the inner diameter of the outer tube 642 and are attached to the distal end of the inner tube 644, which is capable of moving proximally / distally relative to the distal tip 643 of the outer tube. The distal tip 643 has a structure 645 that influences or guides the deformable claws to converge. The structure 645 is configured to take the form of an inner ridge that guides the claws inward as the inner tube advances distally such that the claws converge. Alternatively, the structure may be tapered, stepped, sloped, or any other form that guides the deformable claws to come together. In the retaining position, at least a portion of the retaining member, e.g., the deformable claws, extend beyond the distal tip of the outer elongate member 642. The inner tube with the prongs can be made of a variety of materials, including shape memory materials, such as Nitinol, or Elgiloy, or cobalt chrome, or similar materials that accommodate repeated flexing without fatigue (or with more fatigue resistant properties) at the base of the prongs, if desired. In some embodiments, the movable retention member need not be prong-like, but may be configured, for example, as a thin wire, filament, or paddle-shaped structure, or various shapes and surface finishes, as well as various circumferential distributions.

[0358] A perforation means (punch, microneedle) tool generally has a tubular elongated body with a cylindrical profile and a hollow lumen through the body. According to one embodiment, the at least one retaining member described herein may be positioned not only at the distal portion of the perforation means, but also at various positions along the body of the perforation means, for example, a short distance from the distal end or midway along the body of the perforation means, depending on the structure of the perforation means and its intended purpose. The terms "coupled" or "attached" or "connected" or "mounted" as used herein may mean coupled, attached, incorporated, or mounted directly or indirectly through one or more intervening members.

[0359] As used herein, a "retention member" refers to a structure or mechanism, or several structures and / or mechanisms, that partially or completely retain biological tissue within the lumen of the piercing means. The retention member can translate into or across the lumen, or radially constrict the lumen in a circumferential direction, for example, to simply close tightly around tissue located within the lumen to improve its retention and removal. The retention members described herein can be made of a variety of biocompatible materials, such as polypropylene, polyester, polyurethane, Teflon, Nitinol, stainless steel, etc. The configuration of the retention member can be solid, braided, fibrous, etc., and should not be considered limited to any one particular embodiment.

[0360] According to one embodiment, the retaining member may be movable along the axis of the punch. The retaining member may form an integral part of the elongated body of the punch or may comprise a separate element mounted within the lumen of the elongated body. In another version, the retaining member comprises a portion made of a deformable material, and the tool further comprises an actuator adapted to deform at least the deformable portion of the retaining member and to contract the lumen defined therein. For example, the retaining member comprises a plurality of portions made of a deformable material, each two portions being separated by a spacer made of a substantially rigid material such as Teflon, stainless steel, or titanium. The deformable material may be selected from the group consisting of silicone, rubber, gel, and fluid.

[0361] Another aspect of the invention is a biological tissue removal tool (obviating the use of suction) that includes at least one movable retaining member in communication with a perforation means (punch), at least one of which has a lumen sized to receive a biological sample and a distal tip configured to penetrate a body surface. The retaining member moves relative to the perforation means (punch) between a retracted position and a retaining position in which the retaining member projects proximally of the distal tip into or transversely of the perforation means (punch) to prevent movement of a biological sample received within the lumen toward the distal tip.

[0362] The retaining member may be positioned and movable within the punching means from outside the punching means. In one embodiment, the retaining member is spring biased (e.g., torsion spring biased) to the holding position. In another form, the retaining member slides axially over the punching means (punch) between a retracted position and a holding position, and has a portion that enters the punching means (punch) through an opening in the wall of the elongate body at the holding position. For example, the retaining member may be a clip having at least two portions that enter the lumen through diametrically opposed openings in the wall of the punching means (punch). In some alternative forms, an actuator displaces the retaining member between the retracted position and the holding position, and the actuator may be automated. The retaining member may be rotatable between the retracted position and the holding position.

[0363] Another example of the at least one movable retaining member is as follows: at least a portion of the retaining member is axially movable on the perforation means (punch), and the retaining member is radially movable between a retracted position and a retaining position, such that in the retaining position at least a distal tip of the retaining member extends beyond and converges with a distal tip of the perforation means (punch).

[0364] It is noted that the coring instrument may comprise several microneedles (punches) or a single microneedle (punch). Furthermore, it is noted that each of them may be actuated individually or subgroups of them may be actuated simultaneously. As mentioned above, prior to the coring step, the system aligns the punch(s) substantially perpendicular to the skin.

[0365] According to at least one embodiment, one punch (or needle) is provided. Alternatively, at least five punches (or needles) are provided. The punches (or needles) may rotate together or each individually. According to one embodiment, all punches (or needles) are coupled to one common shaft actuated by an electric DC motor. According to another embodiment, there are several shafts actuated by several electric DC motors.

[0366] According to one embodiment, the coring RPM is between 1000 RPM and 7000 RPM.

[0367] As disclosed below, the excised skin core from each punch / needle is drawn, for example, by vacuum or any retention element(s) (e.g., incorporated within the punch), into an accumulation chamber and ultimately via tubing into a canister for disposal. To ensure that the tubing does not become clogged, liquid (e.g., saline) may be added to the chamber via a drip mechanism to flush the system from at least one of the ends of the punch.

[0368] A vision subsystem, aimed at where the punch tip extends, detects the 3D position of the skin surface and uses a moving arm joint to align the punch(s) perpendicular to the skin plane. The 3D vision subsystem uses either a passive (two cameras) or active (two cameras and an infrared laser projector) stereo vision approach for sub-millimeter accuracy.

[0369] Once aligned, the system translates the rotating punch(s) at high speed against the patient's skin. As the punch(s) approach the skin, the punch(s) decelerate to a slower speed, and then the punch(s) penetrate the skin to a coring depth of 2 mm to 6 mm.

[0370] The punch(s) break and core the skin using rotational shear forces without compressing the skin from the punch tip while inside the skin. Additionally, the system uses closed-loop force sensors and visual feedback to determine when the punch breaks the tougher epidermal layer and when the punch reaches the desired depth within the dermis to avoid unnecessary skin compression.

[0371] According to one embodiment of the present invention, it is emphasized that prior to treatment, a stretching element (e.g., Tegaderm) is used to stretch or stretch the affected skin around it prior to coring, thereby stabilizing the skin (to prevent compression prior to coring).

[0372] At the end of the cycle, the system opens the vacuum line to pull up and remove the skin tissue core. The punch(s) are then pulled back over the skin. Alternatively, the system may include at least one retaining element adapted to hold or contain the excised tissue (without applying a vacuum).

[0373] According to one embodiment, the system can use automation and artificial intelligence algorithms to repeat and realize the described coring procedure according to the treatment plan rules. It is noted that artificial intelligence is also used to determine the treatment plan and the coring protocol (e.g., the pattern of coring elements).

[0374] Each coring cycle forms at least one hole, more preferably six holes. Automation arranges and packs the hole pattern to achieve the planned density.

[0375] The system remembers where previous holes have been made by tracking unique fiducial identifiers, preventing the possibility of hole overlap. Additionally, treatment automation addresses dynamic factors not captured in the treatment plan, such as no-go zones, obstructions to surgical equipment, bleeding, etc.

[0376] The final step, step 103, is directional tightening, in which the skin is compressed in a desired direction with compression tape (as disclosed below). Treatment planning

[0377] Prior to using the device of the present invention, the operator outlines the treatment area to be tightened on the patient's skin. The operator marks the treatment area using a surgical pen and / or an adhesive biocompatible fiducial marker.

[0378] An image of the treatment area with surgical lines and fiducial markers is sufficient for the treatment planning software to automatically recognize and reconstruct the treatment zone in the 3D software environment. Within the treatment planning software, the operator selects the desired area with a skin removal density of 5%-30% and a skin tightening direction.

[0379] Depending on the desired density and depth, the operator selects an appropriate disposable punch. It is noted that according to one embodiment of the present invention, an appropriate disposable punch is automatically recommended by the system (e.g., based on treatment parameters such as skin type, lesion to be treated, desired skin removal density, etc.).

[0380] The punches (microneedles) are sharp, hollow, and range in diameter from about + / - 0.4mm to 4.0mm. Larger holes may increase the rate of treatment, but may not be appropriate for all skin types and lesion types. Typical coring depths are from about 1mm to about 4mm.

[0381] The system of the present invention is positioned and oriented on the patient's skin either manually by an operator or automatically by locating the treatment zone using a vision subsystem, which registers the treatment zone to the treatment plan by looking for specific fiducial identifiers or colored lines on the skin. Coring Instrument and Skin Removal Subsystem

[0382] The instrument uses multiple hollow rotating sharp punches to perform the skin microcoring process. Each punch, shown in Figure 2, has a cylindrical shape with a sharp conical cutting tip on the top. To ensure complete incision, each punch has a sharp inner edge and outer bevel. It should be noted that any other cross-sectional area of ​​the punch would work as well.

[0383] According to one embodiment of the invention, there are X simultaneously rotating punches, where X ranges from 3 to 7. According to one embodiment, all punches rotate together and are coupled to one common shaft operated by an electric DC motor. According to another embodiment, each punch rotates individually and may or may not be coupled to one common shaft operated by an electric DC motor.

[0384] 3A-3D, there is shown the distal end of an applicator having seven punches, six of which surround a seventh punch.

[0385] Figures 3a-3d show two possible punch rotation drive methods: belt drive and friction drive. Figures 3a and 3b show the belt drive punch rotation type before and after operation, respectively. Figures 3c and 3d show the friction drive punch rotation type before and after operation, respectively.

[0386] Referring now to FIG. 3E, another embodiment of the distal end of the applicator having six punches (rather than seven punches as shown in FIGS. 3A-3D) is shown. As shown in FIG. 3e, the six micro-coring needles (punches) are arranged in two groups of three micro-coring needles, each group arranged at the apex of a horizontally laid "V" pattern, i.e., a ">>" pattern. It should be noted that it is within the scope of the present invention for the six micro-coring needles (punches) to be arranged in at least two opposing horizontally laid "V" shapes, i.e., a "><" pattern. However, one skilled in the art will appreciate that any pattern may be used. For example, the pattern of the micro-coring needles (punches) may be selected from the group consisting of a circle, a hexagon, a rectangle, a square, and any combination thereof.

[0387] In some embodiments, the coring RPM is between 1000 RPM and 7000 RPM. The punches can be translated back and forth together on a lead screw or using the robotic arm itself.

[0388] The punches are connected to a skin core accumulation chamber. The excised skin core from each punch is drawn up into the accumulation chamber, e.g., by vacuum (see arrow 401), and eventually drawn via tubing into a canister (not shown) for disposal (see FIG. 4). Note that instead of a vacuum, the system may include at least one retention element adapted to hold or contain the excised tissue (without applying a vacuum). To ensure that the tubing is free of clogging, liquid (e.g., saline) may be added to the chamber via a dripping mechanism to flush the system.

[0389] According to another embodiment, a liquid (eg, saline) is added to reduce friction during the coring step.

[0390] According to one embodiment of the invention, only one arm with one or more punches is utilized in the system. According to another embodiment of the invention, two or more arms, each utilizing one or more punches, are embodied in the system (as shown in FIG. 5a). In such an embodiment, each arm may utilize one or more punches having the same characteristics (width, depth, cross-section, etc.), or each arm encloses one or more punches, each (or all) having individual / separate characteristics.

[0391] According to another embodiment, each arm (and its punch) is characterized by different properties (eg, punch width, depth, cross-section, translational speed, rotational speed, etc.).

[0392] According to alternative embodiments, all arms may include the same mechanism, or each arm may comprise a different mechanism, e.g., a different incision / resection means (e.g., one arm makes the incision and the second arm is used for seeding or insertion / injection of additives (e.g., threads, hyaluronic acid, etc.) as disclosed below).

[0393] According to another embodiment of the invention, each punch is individually actuated, and in some embodiments, there are several punches in at least one arm of the instrument, but since each is individually operated, the operator may only actuate a few of the punches and not all of them.

[0394] According to another embodiment of the invention, the distance between each punch can be adjusted. Referring now to Figure 5b, one arm 510 of the instrument is shown having six punches 520 spaced apart from each other by a distance X (see reference number 521) and a distance Y (see reference number 522). According to one embodiment, said X and Y are adjustable such that the distance between the punches can be changed to better tailor the punches to the treatment. Automation and artificial intelligence algorithms

[0395] According to one embodiment, the system uses automated and artificial intelligence algorithms to analyze the machine visualization input to determine and establish the most appropriate coring pattern and plan. The artificial intelligence then commands the repetition and implementation of the described coring procedures according to the treatment plan rules.

[0396] According to one embodiment, each coring cycle creates six holes arranged in a hexagon (as shown in FIG. 6). It should be noted that any number of punches may be used; six is ​​merely an example.

[0397] Automation positions and packs the hexagonal patterns to achieve the planned density. For example, in Figures 7-9, one instrument design may have spread punches that allow for an overlapping pattern, while another design may have punches that are tightly packed together. The system remembers where previous holes have been made by tracking unique fiducial identifiers, preventing the possibility of overlapping holes. Additionally, treatment automation addresses dynamic elements not captured in the treatment plan, such as no-go zones, obstructions to surgical equipment, bleeding, etc.

[0398] According to one embodiment, the overlapping pattern can have at least one point of excised tissue portion.

[0399] According to another embodiment, the instrument of the present invention also comprises a mechanism configured to step the micro-coring punch and position the micro-coring punch such that an element selected from the group consisting of an apex, a facet, and any combination thereof of the stepped micro-coring punch hexagon intersects an element selected from the group consisting of an apex, a facet, and any combination thereof of the first micro-coring punch hexagon. In some embodiments, the step mechanism is implemented as a stepper that translates the position of the punch such that after the first coring session, the position of the punch is moved for the next coring session.

[0400] According to another embodiment, there may be an overlap between one coring step (by apexes or facets) and the other, and according to another embodiment of the invention, there may be an overlap between successive coring steps (as shown in Figure 7).

[0401] According to another embodiment of the invention, the system utilizes artificial intelligence and / or machine visualization, OCT, ultrasound, machine learning algorithms and / or image processing to determine information regarding the coring location, i.e., the system first scans the tissue to be treated using at least one selected from the group consisting of artificial intelligence, machine visualization, OCT, ultrasound, machine learning algorithms, image processing, and any combination thereof, and the system determines where it would be most beneficial to perform coring. Tightening direction

[0402] At the end of treatment, the operator uses a stretching / compression instrument to close the skin hole and promote healing of the new dimensions of the cored area, such as by compression.

[0403] According to one embodiment of the present invention, the stretching / compression device is an elastic compression tape for closing the skin hole. Compressing the skin allows wound healing and collagen deposition and adhesion of the cored wall according to its modified (compressed) configuration. Thus, compression causes the cored hole to assume an elliptical shape rather than a circle-like shape, and is configured to be stabilized by new collagen in that position, promoting healing with an aesthetic skin tightening outcome (less likely scarring) due to the axially accumulated compression core.

[0404] The stretching / compression devices disclosed herein create a compressive force on the inner area and a tensile force on the outer area to eliminate undesirable puncture scars.

[0405] According to one embodiment of the present invention, the tension applied can be adjusted based on skin type to provide the best results.

[0406] Reference is now made to Figures 10A and 10B, which show one embodiment of a tension / compression device.

[0407] According to this embodiment of the invention, the extension / compression device has a long portion and a short portion. The short portion comprises at least one buckle-like element having at least one slotted hole. The long portion is adapted to be connected to the short side through said at least one slotted hole. The long portion is threaded through said slot and secured to the short portion (described in more detail below). The securing of the long portion to the short portion is performed by attaching at least one adhesive layer of the long portion to at least one adhesive layer of the short portion.

[0408] Reference is now made to Figures 11 and 12, which show the short side of this embodiment of the tension / compression device. According to this embodiment, the short side has a base, an adhesive, and a liner.

[0409] The base may be made from any material having sufficient strength to withstand a shear force of, for example, 10 PSI.

[0410] The base may be made from any material that is strong enough to withstand a shear force of, for example, 10 PSI, and the adhesive is one that adheres well to skin.

[0411] The liner is a covering that protects the adhesive until it is to be used.

[0412] Reference is now made to Figures 13 and 14, which show the long side of this embodiment of the tension / compression device.

[0413] According to this embodiment, the long side has a base, an adhesive, a liner, and a hook and loop sheet.

[0414] The base may be made from any material having sufficient strength to withstand a shear force of, for example, 10 PSI.

[0415] The adhesive may be made from any material that is strong enough to withstand a shear force of, for example, 10 PSI, and that adheres well to skin.

[0416] The liner is a covering that protects the adhesive until it is to be used.

[0417] According to one embodiment, the hook and loop member (e.g., sheet) is Velcro. In one example, the hook sheet is a male side with small semi-rigid hooks on the top surface, and the loop sheet is a female side with thin loops on the top surface. When the hook top surface and the loop top surface come into contact, the hooks hook into the loops.

[0418] The bottom surface of both sheets has adhesive to adhere the sheets to a base. This is not necessary. Alternatively, if the sheet has sufficient strength, it can act as the base layer.

[0419] According to one embodiment, the loop sheet covers most of the contact surface of the strip. This allows for smooth tape movement since the loop sheet can be thinner than the hook sheet. This can also be reversed, with the hook sheet covering most of the strip, but the hook sheet must be thin enough to be flexible enough to fold over (see note on side view).

[0420] Once the stretch / compression device is positioned over the skin perforation, the operator stretches the stretch / compression device to create compression and / or tension to a desired level. Once the desired tension level is reached, the stretch / compression device can be closed to secure it in place.

[0421] Directional tightening of the skin is achieved by application of a tension / compression device.

[0422] The directionality of the skin area to which the stretching / compression device is applied may also be optimized. In certain embodiments, the direction of skin tightening is determined by the directionality of the applied tensile or compressive force, which may be in the x-, y-, and / or z-direction relative to the device or skin area.

[0423] Optimization of the applied tension of the stretching / compression device may provide many advantages. For example, such adjustability may allow real-time control of compressing and / or expanding the stretching / compression device after application of the stretching / compression device to the skin. This level of control may allow for individualized treatment based on the disease, disorder, or condition being treated, the optimal aesthetic effect being achieved, the optimal closure process being achieved, and / or the timing and extent of the healing process observed for a particular patient. Additionally, adjustability may allow less differential control over how an incision or excision is made in an area of ​​skin, and more differential control over selectively closing or opening the incision or excision.

[0424] The stretching / compression device may be applied to the entire skin area to be treated or to a portion of the skin area to be treated. Directional or non-directional tightening may be achieved by creating a geometric arrangement of incisions and / or excisions that are similarly treated. Alternatively, such tightening may be achieved by a non-geometric arrangement of incisions and / or excisions in which only some of the incisions and / or excisions are opened or closed using the stretching / compression device.

[0425] It should be noted that once an incision or excision occurs, the wound healing process begins and, as is commonly known, includes collagen synthesis and maturation. Thus, facilitating the organization and accumulation of per modified coring area(s) is within the core of the present invention.

[0426] The adjustable dressing may include an adhesive layer (e.g., formed from any of the adhesive materials described herein). The adhesive layer may be a continuous layer (i.e., a continuous layer of one or more adhesive materials attached to the proximal surface of the dressing) or a discontinuous layer (i.e., a discontinuous layer of one or more adhesive materials attached to the proximal surface of the dressing). The adhesive layer may include any useful arrangement of adhesive materials. For example, the adhesive layer is adjustable, allowing for control of compression or expansion. In some embodiments, the adhesive layer includes a random, non-geometric, or geometric arrangement of adhesive materials to provide adjustability. In certain embodiments, the arrangement allows for directional or non-directional compression and / or expansion as the dressing compresses and / or expands. In certain embodiments, the adhesive layer is a discontinuous layer and includes an arrangement of adhesive materials (e.g., an arrangement of dots where the dots move closer together as the dressing compresses and move further apart as the dressing expands). Exemplary adhesive materials are described herein and include materials that promote collagen cross-linking, such as riboflavin or rose bengal, synthetic adhesives (e.g., cyanoacrylates, polyethylene glycol, or gelatin-resorcinol-formaldehyde), or biological sealants (e.g., albumin- or fibrin-based sealants that promote clotting).

[0427] The tension / compression device may further include at least one occlusive layer (e.g., to control wettability and / or promote wound healing), at least one absorbent layer (e.g., to absorb wound exudate), at least one reinforcing layer (e.g., a reinforcing layer, optionally formed from low density polyethylene (LDPE), fluorinated ethylene propylene (FEP), or nylon), and / or at least one delivery layer (e.g., to deliver one or more therapeutic agents to enhance the treatment thereof).

[0428] The stretching / compression appliance may be of any aesthetically appealing color, shape, and / or material. For example, the stretching / compression appliance may be provided in a skin tone or is transparent or translucent. Such transparent or translucent dressings may further be useful for visualization, e.g., for real-time adjustability of the dressing, and / or for application of the stretching / compression appliance to the skin area to be treated.

[0429] According to another embodiment of the present invention, the stretching / compression device is first applied (i.e., fixed) to the skin (after excision of a portion of the skin) and only then is tension applied to effect directional tightening of the skin.

[0430] According to another embodiment of the invention, the stretching / compression device is first stretched (after excision of the skin portion) and only thereafter applied (i.e., secured) to the skin. Once the stretching / compression device is applied and stretched, the stretching / compression device (and being elastic, the dressing) compresses back to its original shape, thus applying a compressive tension to the skin and effecting directional tightening of the skin.

[0431] That is, the stretching / compression device may first be subjected to a pre-treatment (a stretching force is applied to the stretching / compression device (eg, by a dedicated tool)) and, once fully / partially stretched, is applied to the skin.

[0432] According to another embodiment of the invention, the stretching / compression device that may be used is simply an adhesive tape, e.g., 3M™ Tegaderm™, HP Transparent Film Dressing (see https: / / www.3m.com / 3M / en_US / company-us / all-3m-products / ~ / 3M-Tegaderm-HP-Transparent-Film-Dressing / ?N=5002385+3293321973&rt=rud). Methods for skin tightening, more specifically, methods for directional skin tightening

[0433] The present invention relates to various methods and instruments (e.g., stretching / compression instruments) used to selectively open or close incisions and / or excisions (e.g., all or part of such incisions and / or excisions, such as microslits, holes, etc.) formed in a skin area by incising or excising tissue portions. The stretching / compression instruments can be applied to the entire skin area to be treated or to a part of the skin area to be treated, thereby allowing directional or non-directional tightening by generating a geometric or non-geometric arrangement of incisions and / or excisions to be treated similarly or differently. Furthermore, the instruments can provide uniform or non-uniform compression and / or squeezing over the entire device or a part thereof. Thus, these methods and instruments can achieve a reduction in skin surface and / or skin tightening.

[0434] The method may include contraction or expansion in one or more directions of at least a portion of the device (e.g., a dressing). The method may, for example, include applying a stretching / compression device to a skin area having multiple incised and / or excised tissue portions (e.g., at least two of the tissue portions have at least one dimension that is less than about 1 mm, or at least one dimension that is greater than about 1 mm). 2 The appliance contracts or expands the skin area in one or more directions (e.g., in the x-direction, y-direction, z-direction, xy-direction, xz-direction, yz-direction, and / or xyz-direction, as described herein), and such contraction or expansion can be uniform or non-uniform. Furthermore, the contraction or expansion can be caused by exposing the applied appliance to one or more external stimuli (e.g., any of those described herein) that are caused by applying a force (e.g., a compressive or stretching force) to the stretching / compression appliance. Furthermore, such contraction and / or expansion can be adjusted after application of the appliance. For example, after treating the skin and applying the appliance, the appliance can further expand or compress the skin area. In this manner, the appliance is adjustable / adjustable.

[0435] The present invention further includes methods for tightening the skin in a preferred direction (eg, directional tightening of the skin (eg, by compression and / or expansion applied by an appliance)).

[0436] The present invention also includes optimizing the dimensions of the incised or excised tissue portion to promote wound healing. Exemplary dimensions include non-circular holes, such as circular holes, elliptical holes, etc. Non-circular holes can be formed by using a device with a non-circular cross-section (e.g., a blade or tube such as a hollow tube with a non-circular cross-section) or by pre-stretching the skin prior to treatment with a device with a circular cross-section (e.g., a circular coring needle creates an elliptical hole in unstretched skin).

[0437] In some embodiments, the long axis of the ellipse is perpendicular to the pre-stretching direction, and the elliptical holes can cause skin tightening preferentially in the direction of the short axis of the ellipse. Thus, a stretching / compression device can be applied to a skin section containing one or more holes, or to one or more incised or excised tissue sections having one or more geometric shapes.

[0438] It should be noted that once an incision or excision occurs, the wound healing process begins and, as is commonly known, includes collagen synthesis and maturation. Thus, facilitating the organization and accumulation of per modified coring area(s) is within the core of the present invention. Adhesive materials that can be incorporated into tension / compression devices

[0439] Adhesives may be used within the dressing (eg, in the adhesive layer) or in combination with any of the methods described herein to promote skin tightening.

[0440] The adhesive may be a pressure sensitive adhesive (PSA). The properties of a pressure sensitive adhesive are influenced by three parameters: tack (initial adhesion), peel strength (adhesion), and shear strength (cohesion). Pressure sensitive adhesives may be synthesized by several methods including solvent-based, water-based, and hot melt methods. Tack is the initial adhesion under conditions of slight pressure and short dwell time and depends on the adhesive's ability to wet the contact surface. Peel strength is the force required to remove the PSA from the contact surface. Peel adhesion depends on many factors including tack, bond history (e.g., force, dwell time), and adhesive composition. Shear strength is a measure of the adhesive's resistance to continuous stress. Shear strength is influenced by several parameters including the internal adhesion, crosslinking, and viscoelastic properties of the adhesive. Permanent adhesives are generally resistant to peeling and have very high peel and shear strengths.

[0441] Exemplary adhesives include biocompatible matrices (e.g., those including at least one of collagen (e.g., collagen sponge), low melting point agarose (LMA), polylactic acid (PLA), and / or hyaluronic acid (e.g., hyaluronan); photosensitizers (e.g., rose bengal, riboflavin-5-phosphate (R-5-P), methylene blue (MB), N-hydroxypyridine-2-(1H)-thione (N-HTP), porphyrins, or chlorins, and precursors thereof); photochemicals (e.g., 1,8 naphthalimide); synthetic adhesives (e.g., cyanoacrylate adhesives, polyethylene glycol adhesives, or gelatin-resorcinol-formaldehyde adhesives); or biological sealants (e.g., a mixture of riboflavin-5-phosphate and fibrinogen, a fibrin-based sealant, an albumin-based sealant, or a starch-based sealant). In certain embodiments, the adhesive is biodegradable.

[0442] Exemplary pressure-sensitive adhesives include natural rubber, synthetic rubber (e.g., styrene-butadiene and styrene-ethylene copolymers), polyvinyl ethers, polyurethanes, acrylics, silicones, and ethylene-vinyl acetate copolymers. The adhesive properties of the copolymers can be modified by changing the composition (through the monomeric components), changing the glass transition temperature (Tg) or the degree of crosslinking. In general, copolymers with lower Tg are less stiff and copolymers with higher Tg are more stiff. The tack of the PSA can be modified by adding components that change the viscosity or mechanical properties. Exemplary pressure-sensitive adhesives are described in Pressure-Sensitive Adhesives for Medical Applications by Czech et al., Wide Spectra of Quality Control, edited by Dr. Isin Akyar, published by InTech, Chapter 17 (2011), the entire contents of which are incorporated herein by reference.

[0443] In one exemplary technique, a photosensitizer (e.g., Rose Bengal (RB) at a concentration of less than 1.0% weight / volume in a buffer (e.g., phosphate buffered saline) to form a skin tissue-RB complex) is added to the tissue, and the tissue is then irradiated with electromagnetic energy to create a seal (e.g., at a wavelength of at least 488, 2000 J / cm). 2 and / or less than 1.5 W / cm 2 Less than about 0.6 W / cm 2 This exemplary technique is described in U.S. Patent No. 7,073,510, the entire contents of which are incorporated by reference. In another exemplary technique, a laser may be used for tissue welding. In yet another exemplary technique, a photochemical is applied to the tissue, and then the tissue is illuminated with visible light to create a seal.

[0444] According to one embodiment of the present invention, therapeutic agents may be incorporated into the tension / compression device for release into the skin puncture to accelerate its healing. Exemplary therapeutic agents include one or more growth factors (e.g., vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), epidermal growth factor (EGF), and keratinocyte growth factor); one or more stem cells (e.g., adipose tissue-derived stem cells and / or bone marrow-derived mesenchymal stem cells), steroids (e.g., steroids to prevent edema), agents to prevent post-inflammatory skin hyperpigmentation (e.g., hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide); one or more pain relievers (e.g., paracetamol / acetaminophen, aspirin, dextrose napsylate, or the like, as described herein). lopropoxyphene, co-codamol, an opioid (e.g., morphine, codeine, oxycodone, hydrocodone, dihydromorphine, pethidine, buprenorphine, tramadol, or methadone), fentanyl, procaine, lidocaine, tetracaine, dibucaine, benzocaine, p-butylaminobenzoic acid 2-(diethylamino)ethyl ester HCl, mepivacaine, piperocaine, dyclonine, or venlafaxine); one or more antibiotics (e.g., cephalosporin, bacitracin, polymyxin B sulfate, neomycin, bismuth tribromocarbonate, or polysporin);One or more antifungal agents (e.g., nystatin), one or more anti-inflammatory agents (e.g., a nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, ketoprofen, flurbiprofen, piroxicam, indomethacin, diclofenac, sulindac, naproxen, aspirin, ketorolac, or tacrolimus), a cyclooxygenase-2-specific inhibitor (a COX-2 inhibitor, such as rofecoxib (Vioxx®), etoricoxib, and and celecoxib (Celebrex®)), glucocorticoid drugs, specific cytokines targeting T lymphocyte function, steroids (e.g., glucocorticoids (e.g., corticosteroids such as aldosterone, beclomethasone, betamethasone, cortisone, deoxycorticosterone acetate, dexamethasone, fludrocortisone acetate, hydrocortisone, methylprednisolone, prednisone, prednisolone, or triamcinolone) or or mineralocorticoid drugs (e.g., aldosterone, corticosterone, or deoxycorticosterone), or immunoselective anti-inflammatory derivatives (e.g., phenylalanine-glutamine-glycine (FEG) and its D-isomer (feG)); one or more antimicrobial agents (e.g., chlorhexidine gluconate, iodine (e.g., tincture of iodine, povidone iodine, or Lugol's iodine), or silver, such as silver nitrate (e.g., as a 0.5% solution), silver sulfadiazine (e.g., as a cream), or Ag in one or more useful carriers (e.g., alginates such as Acticoat®, which comprises a nanocrystalline silver coating on high density polyethylene, available from Smith & Nephew, London, UK, or Silvercel®, which comprises a mixture of alginate, carboxymethylcellulose, and silver-coated nylon fibers, available from Systagenix, Gatwick, UK); +foams (e.g., Contree® Foam, which contains soft hydrophilic polyurethane foam and silver, available from Coloplast A / S, Humlebaek, Denmark); hydrocolloids (e.g., Aquacel® Ag, which contains ionic silver and hydrocolloids, available from Conva Tec, Skillman, New Jersey); or hydrogels (e.g., Medline Silvasorb®, which contains silver in an ionic state, commercially available from Industries, Inc. (Mansfield, Mass.); one or more germicides (e.g., alcohols such as ethanol (e.g., 60-90%), 1-propanol (e.g., 60-70%), and mixtures of 2-propanol / isopropanol); boric acid; calcium hypochlorite; hydrogen peroxide; manuka honey and / or methylglyoxal; phenolic (carbolic acid) compounds (e.g., sodium 3,5-dibromo-4-hydroxybenzenesulfonate, trichlorophenyl methyl iodosalicyl, or triclosan); polyhexanide compounds (e.g., polyhexamethylene biguanide ... nide (PHMB)); quaternary ammonium compounds (e.g., benzalkonium chloride (BAC), benzethonium chloride (BZT), cetyltrimethylammonium bromide (CTMB), cetylpyridinium chloride (CPC), chlorhexidine (e.g., chlorhexidine gluconate) or octenidine (e.g., octenidine dihydrochloride)); sodium bicarbonate; sodium chloride; sodium hypochlorite (e.g., optionally in combination with boric acid in Dakin's solution): or triarylmethane dyes (e.g., brilliant green)); one or more antiproliferative agents (e.g., sirolimus, tacrolimus, zotarolimus, violimus, or paclitaxel); one or more emollients;one or more hemostatic agents (e.g., collagen such as microfibrillar collagen, chitosan, calcium-containing zeolites, cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum, titanium dioxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetylglucosamine, thrombin, clotting factor(s) (e.g., II, V, VII, VIII, IX, X, XI, XIII, or von Willebrand factor, as well as their activated forms), procoagulants (e.g., one or more procoagulants (e.g., any of the hemostatic agents described herein, desmopressin, clotting factor(s) (e.g., II, V, VII, VIII, IX, X, XI, XIII, or von Willebrand factor, as well as activated forms thereof), procoagulants (e.g., propyl gallate), antifibrinolytics (e.g., epsilon aminocaproic acid), etc.); one or more anticoagulants a hematological agent (e.g., heparin or a derivative thereof, such as low molecular weight heparin, fondaparinux, or idraparinux; an antiplatelet agent, such as aspirin, dipyridamole, ticlopidine, clopidogrel, or prasugrel; a factor Xa inhibitor, such as a direct acting factor Xa inhibitor (e.g., apixaban or rivaroxaban); a thrombin inhibitor, such as a direct acting thrombin inhibitor (e.g., argatroban, bivalirudin, dabigatran, hirudin, lepirudin, or ximelagatran; or a coumarin derivative or vitamin K antagonist (e.g., warfarin (Coumadin), acenocoumarol, atromentin, phenindione, or phenprocoumon); one or more immunomodulatory agents, including corticosteroids and nonsteroidal immunomodulatory agents (e.g., NSAIDS as described herein); one or more proteins; one or more vitamins (e.g., vitamin A, vitamin C, and / or vitamin E);

[0445] With respect to the skin tightening methods described herein, the use of anticoagulants and / or procoagulants may be particularly relevant. For example, by controlling the degree of bleeding and / or clotting at the incision and / or excision, the skin tightening effect may be more effectively controlled. Thus, in some embodiments, the methods and devices herein include one or more anticoagulants, one or more procoagulants, one or more hemostatic agents, or combinations thereof. In certain embodiments, the therapeutic agent controls the degree of bleeding and / or clotting in the treated skin area, including the use of one or more anticoagulants (e.g., to inhibit blood clot formation before skin healing or slit / hole closure) and / or one or more hemostatic or procoagulant agents. Methods for Treating Skin Areas

[0446] The present invention relates to methods and devices that can be applied to the skin area to be treated. In certain embodiments, these areas are treated with one or more procedures to improve the appearance of the skin. Thus, the stretching / compression devices and methods herein can be used for skin rejuvenation (e.g., pigment removal, tattoo removal, veins (e.g., spider veins or reticular veins), and / or blood vessels in the skin), or for the treatment of acne, allodynia, age spots, ectopic dermatitis, hyperpigmentation, hyperplasia (e.g., lentigines or keratoses), loss of transparency, loss of elasticity, melasma (e.g., epidermal, dermal, or mixed subtypes), photodamage, rash (e.g., erythematous, macular, papular, and / or vesicular conditions), psoriasis, fine lines (or wrinkles, e.g., crow's feet, age-related fine lines, sun damage, etc.). In some embodiments, the present invention may be useful for treating skin conditions such as fine lines associated with aging, fine lines associated with aging skin, or fine lines associated with genetics, paleness, cicatricial contracture (e.g., loosening of scar tissue), scarring (e.g., due to acne, surgery, or other trauma), skin aging, skin contraction (e.g., excessive tension on the skin), skin irritation / sensitivity, skin laxity (e.g., loose or sagging skin, or other skin abnormalities), striae (or stretch marks), vascular lesions (e.g., angioma, erythema, hemangioma, papules, port wine stains, rosacea, reticular veins, or telangiectasias), or any other undesirable skin abnormality.

[0447] Such treatments may include treatment of any part of the body, including the face (e.g., eyelids, cheeks, chin, forehead, lips, or nose), neck, thighs, chest (e.g., as in a breast lift), arms, legs, nose, forehead, buttocks, and / or back. Thus, the devices of the present invention may be arranged or configured to accommodate the sizes or shapes of different body regions. Such arrangements and configurations may include any useful shape (e.g., linear, curvilinear, or star-shaped), size, and / or depth.

[0448] In some embodiments, the incised or excised tissue portion forms a hole in the skin area, and the diameter or width of the hole is less than about 1.0 mm, resulting in a tissue portion having a diameter or width of less than about 2.0 mm. In further embodiments, the tissue portion has a diameter or width of less than about 2.0 mm and a length of more than about 1.0 mm. In certain embodiments, the relatively small dimensions of the tissue portion can promote healing while minimizing scar formation.

[0449] Moreover, fractional treatment resulting in multiple tissue portions may be incised or excised in any beneficial pattern within the skin region. Exemplary patterns within the skin region include tile patterns or fractal-like shapes, and an array of hollow tubes may be arranged, for example, within the base, to achieve such patterns (see Figs. 7-9). It is emphasized that according to one embodiment of the invention, there may be an overlap (by vertices or facets) between one coring step and the other, and according to another embodiment of the invention, there may be an overlap in the cross-section between successive coring steps (as shown in Fig. 7). That is, the first cross-sectional area of ​​the first coring step is hexagonal, as shown, for example, in Fig. 7. According to one embodiment of the invention, the next step may perform coring at any position within said hexagonal cross-section of the first step.

[0450] According to another embodiment of the present invention, a higher density and / or a smaller spacing of tissue portions (e.g., slits and / or holes) may be incised or excised in the skin at the center of the pattern or in thicker portions of the skin. In another example, the pattern in the skin may be a random, staggered, parallel, circular, spiral, square or rectangular, triangular, hexagonal, radial distribution of incised or excised tissue portions, or a combination of one or more such patterns. The pattern may result from modifying the average length, depth, or width of the incised or excised tissue portions, as well as the density, orientation, and spacing between such incisions and / or excisions (e.g., by using an instrument with one or more blades or tubes with different lengths, widths, or geometries arranged in a particular density or spacing pattern). Such patterns can be optimized to promote unidirectional, non-directional, or multi-directional contraction or expansion of the skin (e.g., in the x-direction, y-direction, x-direction, xy-plane, yz-plane, xz-plane, and / or xyz-plane), for example, by modifying the average length, depth, width, density, orientation, and / or spacing between incisions and / or excisions.

[0451] Any useful portion of the skin can be incised or excised. Such tissue portions can include epidermal tissue, dermal tissue, and / or cells or tissues (e.g., stem cells) adjacent to the dermis / adipose layer boundary.

[0452] According to another embodiment of the present invention, a tissue hole (leading to the removal of tissue or one or more tissue portions from a skin region, i.e., excised tissue) may be achieved using a scalpel, application of energy (e.g., laser), coblation, coagulation, ultrasound, microwave energy, RF, application of heat (to vaporize a skin portion), a mechanical applicator that "pierces" the skin while suction is applied (during or after the piercing) to remove the excised skin portion, or any other instrument. For example, an excision may include any tissue or tissue portion removed from a skin region, which may form an excised tissue portion having a particular geometric shape (e.g., cylindrical, rectangular, triangular, etc., or any shape) to create one or more holes (i.e., negative space created by the removal of tissue) in the skin region. Exemplary methods of forming excised tissue portions or excisions include the use of one or more hollow needles (optionally including one or more notches, extensions, protrusions, and / or barbs), one or more micro-augers, one or more micro-abraders, any useful tool for forming excisions, or any of the methods and devices described herein. Safety Subsystem

[0453] According to one embodiment of the present invention, the following safety issues are taken into consideration: Emergency power disconnect switch that immediately removes all energy and motion from the system All moving robot arms will stop and, in the event of total power loss, will slowly lower to rest The needle / punch is automatically retracted to a safe position within the mechanism in the event of power loss All robot arms are integrated with force sensors that can detect excessive force and stop it immediately. Movement speed is limited to less than 500mm / s and less than 50mm / s while moving from one coring position to another during treatment Movement during coring is limited to 20mm, with maximum allowable orientation of less than 10 degrees The imaging system continuously monitors the distance between the punch and the skin. All computer-controlled movements are user initiated These movements can be quickly stopped via the user interface

[0454] Reference is now made to FIG. 17, which shows histological analysis of tissue cross sections 0, 2 and 5 weeks after fractional coring (tissue removal) treatment.

[0455] As can be seen, immediately after treatment (week 0), a split hole is formed after excision of the cored tissue.

[0456] After 2 and 5 weeks, healing occurred, including fibroblast migration and collagen synthesis and maturation, and the skin tightened.

[0457] According to another embodiment of the present invention, the ablated tissue may follow any embodiment as disclosed above, however, the directional tightening may further be performed by the use of at least one energy source selected from the group consisting of application of temperature to heat and expel tissue, application of laser, RF, coblation, coagulation, microwave energy, ultrasound, application of any other type of energy, and any combination thereof.

[0458] In such embodiments, for example, RF electrodes may be applied either to the entire skin area to be treated or to the areas between each ablation region.

[0459] Reference is now made to Figures 15-16 which show diagrammatically such an embodiment.

[0460] 15a shows a schematic representation of a skin region with multiple ablation sites 150. Also incorporated in this figure is an RF electrode 150 adapted to apply energy to the skin after ablation to effect directional tightening. It is within the scope of the present invention that when RF energy is applied to the tissue, a differential magnetic field is generated between the ablated tissue to effect skin tightening (see arrows 152).

[0461] Note that the energy applied by the RF electrodes (or a different energy source) can be, for example, as shown in FIG. 15b (see arrow 153) or FIG. 15c (see arrow 154).

[0462] According to another embodiment, where applicable, two RF electrodes are used (one on a different side of the skin) (see FIG. 15d).

[0463] Referring now to Fig. 16, which illustrates a schematic representation of another embodiment of the present invention, the energy (in this case, RF energy) applied to the skin tissue is divided into several segments (Fig. 16 shows five segments X1-X5), each section adapted to apply a different amount of energy to the tissue. Such energy levels can be adjusted to optimize the treatment.

[0464] It is emphasized that although Figures 15-16 show RF electrodes and RF energy, the same applies to the application of lasers, RF, pulsed electromagnetic fields, coblation, coagulation, microwave energy, ultrasound, application of other types of energy, and combinations thereof. Combining energy-based and machine-based coring

[0465] According to another embodiment of the present invention, the punch / needle is also adapted to apply RF energy to the skin and tissue.

[0466] According to such embodiments, the punch / needle is adapted to penetrate and coring the skin (to create multiple excised tissue portions) and simultaneously or sequentially deliver RF energy to heat and fractionally ablate / coagulate the tissue. In such embodiments, the punch / needle is essentially an RF electrode as well as a cutting element.

[0467] It is within the scope of the present invention that application of RF energy to the skin facilitates tissue ablation and impinges on tissue from wound healing through ablation and coagulation.

[0468] According to one embodiment, each punch / needle is in communication with at least one RF generator.

[0469] According to one embodiment, all punches / needles are in communication with at least one RF generator.

[0470] According to another embodiment of the present invention, a pulsed electromagnetic frequency generator is in communication with at least one of said punches / needles. According to another embodiment, the pulsed electromagnetic frequency generator is adapted to generate a dynamic magnetic field such that an electromagnetic pulse is delivered to said area of ​​the patient's skin. According to another embodiment, said electromagnetic pulse varies with time.

[0471] According to another embodiment, the dynamic magnetic field is generated by at least one coil. According to another embodiment, at least one of the punches / needles is at least partially wound by at least one coil. According to another embodiment, all punches / needles are at least partially wound by one coil.

[0472] According to another embodiment of the invention, all of said punches / needles are adapted to simultaneously deliver said electromagnetic pulses and apply RF energy to said area of ​​the patient's skin. According to one embodiment of the invention, said RF energy is applied in the form of heat to said area of ​​the patient's skin.

[0473] According to another embodiment of the invention, a control unit monitors and / or controls the application of heat (by RF energy) to tissue within said region of skin.

[0474] According to another embodiment of the present invention, the shape of the electromagnetic pulse is selected from the group consisting of a square wave, a sine wave, a triangle wave, a sawtooth wave, a ramp wave, a spike wave, or any combination thereof.

[0475] According to another embodiment of the present invention, the magnetic field strength B of each pulse applied by the pulsed electromagnetic frequency generator ranges from about 0 Tesla to about 3 Tesla.

[0476] According to another embodiment of the present invention, the magnetic field strength B of each pulse applied by the pulsed electromagnetic frequency generator ranges from about 0 Gauss to about 40 Gauss.

[0477] According to another embodiment of the present invention, the duration of each pulse applied by the pulsed electromagnetic frequency generator ranges from about 3 milliseconds to about 1000 milliseconds.

[0478] According to another embodiment of the present invention, the frequency F applied by the pulses of the pulsed electromagnetic frequency generator ranges from about 1 Hz to about 40 MHz.

[0479] According to another embodiment of the present invention, the energy E applied by the pulses of the pulsed electromagnetic frequency generator ranges from about 1 Watt to about 150 Watts per pulse, or any combination thereof.

[0480] According to another embodiment of the present invention, the frequency F applied by the pulses applied by said step of applying pulsed electromagnetic therapy to said area is greater than about 1 Hz and less than about 1 MHz.

[0481] According to another embodiment of the invention, the frequency F applied by the electromagnetic field pulse is in the range of 1 Hz to 50 Hz.

[0482] According to another embodiment of the present invention, the frequency of the RF energy is in the range of 200 kHz to 10 MHz.

[0483] According to another embodiment of the invention, the power P applied by the RF energy pulses is an RMS average power between 1W and 100W.

[0484] According to another embodiment of the invention, at least one temperature sensor is provided.

[0485] According to another embodiment of the invention, the temperature T reached by the tissue is greater than about 30 degrees and less than about 100 degrees.

[0486] According to another embodiment of the present invention, a skin cooling mechanism is provided to regulate the temperature of the skin (applied by the RF energy).

[0487] According to another embodiment of the present invention, the instrument further comprises at least one RF electrode (in addition to the coring element, ie punch / needle) adapted to apply RF energy to the skin and tissue.

[0488] According to such an embodiment, the punch / needle penetrates and coring the skin (to create multiple excised tissue portions) and the RF electrodes are adapted to simultaneously or sequentially deliver RF energy to heat and fractionally ablate / coagulate the tissue.

[0489] It is within the scope of the present invention that the application of RF energy to the skin not only facilitates tissue removal, but also applies ablative and coagulative treatments to tissue.

[0490] According to one embodiment, the RF electrode is in communication with at least one RF generator.

[0491] According to another embodiment of the present invention, a pulsed electromagnetic frequency generator is in communication with at least one RF electrode. According to another embodiment, the pulsed electromagnetic frequency generator is adapted to generate a dynamic magnetic field such that an electromagnetic pulse is delivered to said area of ​​the patient's skin. According to another embodiment, said electromagnetic pulse varies with time.

[0492] According to another embodiment, the dynamic magnetic field is generated by at least one coil. According to another embodiment, at least one of the RF electrodes is at least partially surrounded by at least one coil. According to another embodiment, all of the RF electrodes are at least partially surrounded by one coil.

[0493] According to another embodiment of the invention, all of said RF electrodes are adapted to simultaneously deliver said electromagnetic pulses to said area of ​​the patient's skin and apply Rf energy. According to one embodiment of the invention, said RF energy is applied to said area of ​​the patient's skin in the form of heat.

[0494] According to another embodiment of the invention, a control unit monitors and / or controls said application of heat (by RF energy) to tissue within said area of ​​skin.

[0495] According to another embodiment of the present invention, the shape of the electromagnetic pulse is selected from the group consisting of a square wave, a sine wave, a triangle wave, a sawtooth wave, a ramp wave, a spike wave, or any combination thereof.

[0496] According to another embodiment of the present invention, the magnetic field strength B of each pulse applied by the pulsed electromagnetic frequency generator ranges from about 0 Tesla to about 3 Tesla.

[0497] According to another embodiment of the present invention, the magnetic field strength B of each pulse applied by the pulsed electromagnetic frequency generator ranges from about 0 Gauss to about 40 Gauss.

[0498] According to another embodiment of the present invention, the duration of each pulse applied by the pulsed electromagnetic frequency generator ranges from about 3 milliseconds to about 1000 milliseconds.

[0499] According to another embodiment of the present invention, the frequency F applied by the pulses of the pulsed electromagnetic frequency generator ranges from about 1 Hz to about 40 MHz.

[0500] According to another embodiment of the present invention, the energy E applied by the pulses of the pulsed electromagnetic frequency generator ranges from about 1 Watt to about 150 Watts per pulse, or any combination thereof.

[0501] According to another embodiment of the present invention, the frequency F applied by the pulses applied by said step of applying pulsed electromagnetic therapy to said area is greater than about 1 Hz and less than about 1 MHz.

[0502] According to another embodiment of the invention, the frequency F applied by the electromagnetic field pulse is in the range of 1 Hz to 50 Hz.

[0503] According to another embodiment of the present invention, the frequency of the RF energy is in the range of 200 kHz to 10 MHz.

[0504] According to another embodiment of the invention, the power P applied by the RF energy pulses is an RMS average power between 1W and 100W.

[0505] According to another embodiment of the invention, at least one temperature sensor is provided.

[0506] According to another embodiment of the invention, the temperature T reached by the tissue is greater than about 30 degrees and less than about 100 degrees.

[0507] According to another embodiment of the present invention, a skin cooling mechanism is provided to regulate the temperature of the skin (applied by the RF energy). Impedance / Temperature Measurement

[0508] According to another embodiment of the invention, at least one impedance / temperature sensor(s) is embedded in the distal-most end of at least one of the punches to provide an indication as to the depth of penetration of at least one of the punches respectively. Such information may be utilized to indicate whether each punch is within or outside of a preferred treatment zone. Cutting element

[0509] According to another embodiment of the present invention, the skin coring instrument (i.e., punch / needle) comprises at least one cutting element (e.g., at least one blade) adapted to crush / comminute the cored / excised tissue to facilitate removal of the tissue.

[0510] At least one cutting element may be incorporated into or in communication with the punch / needle.

[0511] As mentioned above, according to one object of the present invention, the system comprises at least one vacuum subsystem adapted to apply suction to remove the excised portion of the skin tissue. The incorporation of at least one cutting element in the system facilitates the removal of the excised tissue by the vacuum subsystem. Alternatively, the cutting element facilitates the removal of the cored / excised tissue with the aid of a holding member. Injectable substances

[0512] According to another embodiment of the invention, at least one needle is provided with a punch for injecting a treatment substance into the treatment area.

[0513] According to another embodiment of the invention, the punch is a needle adapted to inject a treatment substance into the treatment area.

[0514] According to another embodiment of the present invention, the needles can be either uniform or non-uniform in size.

[0515] According to another embodiment of the present invention, the therapeutic substance may be selected from the group consisting of hyaluronic acid, Botox, collagen, stem cells, or any of the adhesives mentioned above.

[0516] Accordingly, there is provided a method for directional skin tightening of a skin area, comprising: (ii) creating a plurality of excised tissue portions in an area of ​​skin tissue; (ii) applying energy to the skin area to contract or expand the skin area in a predetermined direction to effect directional skin tightening in the skin tissue; It is within the scope of the present invention to provide a method comprising:

[0517] Another object of the present invention is to provide a method as defined above, further comprising the step of applying a stretching tension to said skin area prior to said step of creating a plurality of excised tissue portions.

[0518] Another object of the present invention is to provide a method as defined above, wherein said directional skin tightening is performed in a direction selected from the group consisting of x-direction, y-direction and / or z-direction, and any combination thereof.

[0519] Another object of the present invention is to provide a method as defined above, wherein said step of creating a plurality of excised tissue portions in an area of ​​skin tissue is performed by means selected from the group consisting of mechanical means, application of temperature to heat and expel tissue, application of laser, RF, pulsed electromagnetic fields, coblation, coagulation, microwave energy, ultrasound, application of any other type of energy, and any combination thereof.

[0520] Another object of the present invention is to provide a method as defined above, wherein the step of applying energy to said skin area to contract or expand said skin area is performed by means selected from the group consisting of mechanical means, temperature application to heat and expel tissue, application of a laser, RF, pulsed electromagnetic fields, coblation, coagulation, microwave energy, ultrasound, and application of any other type of energy, and any combination thereof.

[0521] Another object of the present invention is to provide a method as defined above, wherein the step of creating a plurality of excised tissue portions in an area of ​​skin tissue is performed by a system comprising at least one robotic arm, said at least one robotic arm comprising at least one skin coring device.

[0522] Another object of the present invention is to provide a method as defined above, wherein the at least one skin coring instrument comprises a plurality of punches configured to contact a surface of the skin to create holes in the skin tissue by excised portions of the skin tissue.

[0523] Another object of the present invention is to provide an instrument or method as defined above, wherein said plurality of punches is at least seven punches, six of which are arranged in the shape of a hexagon with a seventh, central punch at the centre.

[0524] Another object of the present invention is to provide an instrument or method as defined above, wherein said plurality of punches is at least six punches, five of which are arranged in the shape of a pentagon centered on a sixth, central punch.

[0525] Another object of the present invention is to provide a method as defined above, wherein at least a portion of said plurality of punches are disposable.

[0526] Another object of the invention is to provide a method as defined above, wherein said multiple punches are adapted to penetrate said skin simultaneously or sequentially.

[0527] Another object of the invention is to provide a method as defined above, wherein said punches are characterized by similar or substantially different cross-sectional areas.

[0528] Another object of the invention is to provide a method as defined above, wherein said punches are adapted to penetrate to a depth of between 1 mm and 4 mm into said skin.

[0529] Another object of the invention is to provide a method as defined above, wherein at least some of said plurality of punches are characterized by a radius between 0.15 mm and 2.0 mm.

[0530] Another object of the present invention is to provide a method as defined above, wherein said cross-sectional area is selected from the group consisting of a circle, a rectangle, a triangle, a hexagon, an ellipse, a staggered array, a parallel array, a spiral pattern, a square or rectangular pattern, a radial distribution, and any combination thereof.

[0531] Another object of the invention is to provide a method as defined above, wherein said system further comprises at least one controller adapted to control the positioning of said at least one robotic arm relative to said skin area.

[0532] Another object of the present invention is to provide a method as defined above, wherein said controller comprises at least one engine adapted to control at least one parameter selected from the group consisting of rotation, translation, penetration angle of said at least one robotic arm relative to said skin, penetration depth, coverage, diameter of at least one excised tissue multiplied by number of cores, different areas of said skin to be treated, and any combination thereof.

[0533] Another object of the invention is to provide a method as defined above, wherein said parameters are manually adjusted by an operator or automatically adjusted by said controller.

[0534] Another object of the invention is to provide a method as defined above, in which said parameters are adjusted in real time.

[0535] Another object of the present invention is to provide a method as defined above, wherein the speed of said rotation ranges from 1000 RPM to 7000 RPM.

[0536] Another object of the invention is to provide a method as defined above, wherein the speed of said translation ranges from 0 mm / s to 500 mm / s.

[0537] Another object of the invention is to provide a method as defined above, wherein the translation of the at least one robotic arm relative to the skin varies as the at least one robotic arm approaches the skin.

[0538] Another object of the invention is to provide a method as defined above, wherein said rotation of said at least one robotic arm varies as said at least one robotic arm approaches and penetrates the skin.

[0539] Another object of the present invention is to provide a method as defined above, wherein each punch of said plurality of punches rotates individually in a predetermined direction at a predetermined speed.

[0540] Another object of the invention is to provide a method as defined above, in which said punches rotate simultaneously.

[0541] Another object of the present invention is to provide a method as defined above, wherein each punch of said plurality of punches translates individually.

[0542] Another object of the invention is to provide a method as defined above, in which said punches translate simultaneously.

[0543] Another object of the invention is to provide a method as defined above, wherein said controller comprises a stop mechanism adapted to limit the depth to which at least some of said plurality of punches penetrate into said skin.

[0544] Another object of the invention is to provide a method as defined above, wherein said penetration angle is substantially perpendicular to said skin.

[0545] Another object of the present invention is to provide a method as defined above, wherein said controller is adapted to define at least one no-fly zone, said no-fly zone being defined as an area within which said system does not apply treatment.

[0546] Another object of the present invention is to provide a method as defined above, wherein said system further delivers an additive to the skin.

[0547] Another object of the present invention is to provide a method as defined above, wherein said additive is selected from the group consisting of: a therapeutic agent, saline growth factor, platelet derived growth factor (PDGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), epidermal growth factor (EGF), and keratinocyte growth factor; one or more stem cells; a steroid, an agent preventing post-inflammatory skin hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungals; one or more anti-inflammatory agents, or mineralocorticoid agents, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; a foam; or a hydrogel, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, procoagulants, antifibrinolytic agents, one or more procoagulants, one or more anticoagulants, one or more immunomodulatory agents including corticosteroids and non-steroidal immunomodulatory agents, one or more proteins; or one or more vitamins and any combination thereof.

[0548] Another object of the present invention is to provide a method as defined above, wherein said system further comprises at least one imaging subsystem adapted to guide said at least one skin coring instrument.

[0549] Another object of the present invention is to provide a method as defined above, wherein said imaging subsystem comprises at least one selected from the group consisting of at least one camera, subcutaneous imaging such as ultrasound-based imaging, OCT, and any combination thereof.

[0550] Another object of the present invention is to provide a method as defined above, wherein said system further comprises at least one vacuum subsystem adapted to provide suction to remove the excised portion of said skin tissue.

[0551] Another object of the present invention is to provide a method as defined above, wherein said skin may be part of a treatment area selected from the group consisting of forehead, cheeks, jawline, neck, thighs, upper arms, stomach, abdomen, face, eyelids, nose, forehead, chin, forehead, lips, nose, neck, chest, legs, back and any combination thereof.

[0552] Another object of the present invention is to provide a method as defined above used for localized removal of excess dermal tissue for skin tightening, at least partial scar removal, skin rejuvenation, at least partial removal of pigment, at least partial tattoo removal, veins, acne, allodynia, age spots, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigines or keratoses, loss of transparency, loss of elasticity, melasma, photodamage, xerosis, fine lines, wrinkles, paleness, scar contracture, scarring, wrinkles, folds, acne scars, dyschromia, striae, surgical scars, cellulite, tattoo removal, malar lines, facial lines, facial folds, skin aging, skin contraction, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangiomas, papules, port wine stains, rosacea, venules reticulata, or telangiectasias, or any other undesirable skin abnormality and any combination thereof.

[0553] Another object of the present invention is to provide a method as defined above, wherein said system utilizes at least one selected from the group consisting of mechanical visualization, OCT, ultrasound, machine learning algorithms, artificial intelligence, image processing, and any combination thereof to efficiently select preferred locations of the tissue to be treated to improve the outcome of said treatment.

[0554] Another object of the present invention is to provide a method as defined above, wherein the area percentage of the excised tissue portion is between about 5% and about 30% of the skin area.

[0555] Another object of the present invention is to provide a method as defined above, wherein the area percentage of the ablated tissue portion is less than about 10% of the skin area.

[0556] Another object of the invention is to provide a method as defined above, comprising a step of pre-stretching the skin area prior to the step of creating a plurality of excised tissues.

[0557] Another object of the present invention is to provide a directional skin tightening system for a skin area, comprising: (i) a means for creating a plurality of excised tissue portions in an area of ​​skin tissue; (ii) means for applying at least one type of energy to the skin area to contract or expand the skin area in a predetermined direction to effect directional skin tightening in the skin tissue; The object of the present invention is to provide a system comprising:

[0558] Another object of the present invention is to provide a system as defined above, further comprising means for applying a stretching tension to said skin area prior to said step of creating a plurality of excised tissue portions.

[0559] Another object of the present invention is to provide a system as defined above, wherein said directional skin tightening is performed in a direction selected from the group consisting of x-direction, y-direction and / or z-direction, and any combination thereof.

[0560] Another object of the present invention is to provide a system as defined above, wherein said means for creating a plurality of excised tissue portions in an area of ​​skin tissue comprises means selected from the group consisting of mechanical means, temperature application for heating and expelling tissue, laser application, RF, coblation, coagulation, microwave energy, pulsed electromagnetic fields, ultrasound, and any other type of energy application, and any combination thereof.

[0561] Another object of the present invention is to provide a system as defined above, wherein said means for applying energy to said skin area to contract or expand said skin area comprises means selected from the group consisting of mechanical means, temperature application to heat and expel tissue, application of laser, RF, pulsed electromagnetic fields, coblation, coagulation, microwave energy, ultrasound, and application of any other type of energy, and any combination thereof.

[0562] Another object of the present invention is to provide a system as defined above, wherein the means for creating a plurality of excised tissue portions in an area of ​​skin tissue comprises a system comprising at least one robotic arm, said at least one robotic arm comprising at least one skin coring device.

[0563] Another object of the present invention is to provide a system as defined above, wherein the at least one skin coring instrument (e.g., a skin corer) comprises a plurality of punches configured to contact a surface of the skin to generate holes in the skin tissue by excising portions of the skin tissue.

[0564] Another object of the invention is to provide a system as defined above, wherein said plurality of punches is at least seven punches, six of which are arranged in the shape of a hexagon centered on a seventh, central punch.

[0565] Another object of the invention is to provide a system as defined above, wherein said plurality of punches is at least six punches, five of which are arranged in the shape of a pentagon centered on a sixth, central punch.

[0566] Another object of the present invention is to provide a system as defined above, wherein at least a portion of said plurality of punches are disposable.

[0567] Another object of the invention is to provide a system as defined above, wherein said multiple punches are adapted to penetrate said skin simultaneously or sequentially.

[0568] Another object of the invention is to provide a system as defined above, wherein said punches are characterized either by similar cross-sectional areas or by substantially different cross-sectional areas.

[0569] Another object of the invention is to provide a system as defined above, wherein said punches are adapted to penetrate to a depth of between 1 mm and 4 mm into said skin.

[0570] Another object of the invention is to provide a system as defined above, wherein at least some of said plurality of punches are characterized by a radius between 0.15 mm and 2.0 mm.

[0571] Another object of the present invention is to provide a system as defined above, wherein said cross-sectional area is selected from the group consisting of a circle, a rectangle, a triangle, a hexagon, an ellipse, a staggered array, a parallel array, a spiral pattern, a square or rectangular pattern, a radial distribution, and any combination thereof.

[0572] Another object of the invention is to provide a system as defined above, further comprising at least one controller adapted to control the positioning of said at least one robotic arm relative to said skin area.

[0573] Another object of the present invention is to provide a system as defined above, wherein said controller comprises at least one engine adapted to control at least one parameter selected from the group consisting of rotation, translation, penetration angle of said at least one robotic arm relative to said skin, penetration depth, coverage, diameter of at least one excised tissue multiplied by number of cores, different areas of said skin to be treated, and any combination thereof.

[0574] Another object of the invention is to provide a system as defined above, in which said parameters are manually adjusted by an operator or automatically adjusted by said controller.

[0575] Another object of the invention is to provide a system as defined above, in which said parameters are adjusted in real time.

[0576] Another object of the invention is to provide a system as defined above, in which the speed of said rotation ranges from 1000 RPM to 7000 RPM.

[0577] Another object of the invention is to provide a system as defined above, in which the speed of said translation ranges from 0 mm / s to 500 mm / s.

[0578] Another object of the invention is to provide a system as defined above, wherein the translation of the at least one robotic arm relative to the skin varies as the at least one robotic arm approaches the skin.

[0579] Another object of the invention is to provide a system as defined above, wherein said rotation of said at least one robotic arm varies as it approaches and penetrates the skin.

[0580] It is another object of the present invention to provide a system as defined above, wherein each punch of said plurality of punches rotates individually in a predetermined direction at a predetermined speed, hi some embodiments the rotor is configured to rotate the punches at the same speed.

[0581] Another object of the invention is to provide a system as defined above, in which said punches rotate simultaneously.

[0582] Another object of the present invention is to provide a system as defined above, in which each punch of said plurality of punches translates individually.

[0583] Another object of the invention is to provide a system as defined above, in which said punches translate simultaneously.

[0584] Another object of the invention is to provide a system as defined above, wherein said controller comprises a stop mechanism adapted to limit the depth to which at least some of said plurality of punches penetrate into said skin.

[0585] Another object of the invention is to provide a system as defined above, wherein said penetration angle is substantially perpendicular to said skin.

[0586] Another object of the present invention is to provide a system as defined above, wherein said controller is adapted to define at least one no-fly zone, said no-fly zone being defined as an area within which said system does not apply treatment.

[0587] In some embodiments, a controller, such as may be utilized to perform the control of one or more components, includes a processor configured to communicate with a non-transitory computer-readable medium. The non-transitory computer-readable medium may be configured as a memory configured to store instructions that, when executed by the processor, cause the processor to execute the instructions.

[0588] Another object of the present invention is to provide a system as defined above, which further delivers additives to the skin.

[0589] Another object of the present invention is to provide a system as defined above, wherein said additive is selected from the group consisting of: a therapeutic agent, saline growth factor, platelet derived growth factor (PDGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), epidermal growth factor (EGF), and keratinocyte growth factor; one or more stem cells; a steroid, an agent for preventing post-inflammatory skin hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungals; one or more anti-inflammatory agents, or mineralocorticoid agents, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; a foam; or a hydrogel, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, procoagulants, antifibrinolytic agents, one or more procoagulants, one or more anticoagulants, one or more immunomodulators including corticosteroids and nonsteroidal immunomodulators, one or more proteins; or one or more vitamins and any combination thereof.

[0590] Another object of the present invention is to provide a system as defined above, further comprising at least one imaging subsystem adapted to guide said at least one skin coring instrument.

[0591] Another object of the present invention is to provide a system as defined above, wherein said imaging subsystem comprises at least one selected from the group consisting of at least one camera, subcutaneous imaging such as ultrasound-based imaging, OCT, and any combination thereof.

[0592] Another object of the present invention is to provide a system as defined above, further comprising at least one vacuum subsystem adapted to provide suction to remove the excised portion of said skin tissue.

[0593] Another object of the present invention is to provide a system as defined above, wherein said skin may be part of a treatment area selected from the group consisting of forehead, cheeks, jawline, neck, thighs, upper arms, stomach, abdomen, face, eyelids, nose, forehead, chin, forehead, lips, nose, chest, legs, back and any combination thereof.

[0594] Another object of the present invention is to provide a system as defined above for use in localized removal of excess dermal tissue for skin tightening, at least partial scar removal, skin rejuvenation, at least partial removal of pigment, at least partial tattoo removal, veins, acne, allodynia, age spots, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigines or keratoses, loss of translucency, loss of elasticity, melasma, photodamage, xerosis, fine lines, wrinkles, paleness, scar contracture, scarring, wrinkles, folds, acne scars, dyschromatosis, striae, surgical scars, cellulite, tattoo removal, malar lines, facial lines, facial folds, skin aging, skin contraction, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangiomas, papules, port wine stains, rosacea, venules reticulata, or telangiectasias, or any other undesirable skin abnormality and any combination thereof.

[0595] Another object of the present invention is to provide a system as defined above, which utilizes at least one selected from the group consisting of mechanical visualization, OCT, ultrasound, machine learning algorithms, artificial intelligence, image processing, and any combination thereof to efficiently select preferred locations of the tissue to be treated to enhance the outcome of said treatment.

[0596] Another object of the present invention is to provide a system as defined above, wherein the area percentage of the ablated tissue portion is between about 5% and about 30% of the skin area.

[0597] Another object of the present invention is to provide a system as defined above, in which the area percentage of the ablated tissue is less than about 10% of the skin area.

[0598] Another object of the invention is to provide a system as defined above, which comprises pre-stretching the skin area before creating the plurality of excised tissues.

[0599] According to another embodiment of the present invention, the skin coring instrument (i.e. punch / needle) comprises at least one cutting element (e.g. at least one blade) adapted to crush / comminute the cored / excised tissue to facilitate removal of the tissue. As mentioned above, according to one object of the present invention, the system comprises at least one vacuum subsystem adapted to apply suction to remove the excised portion of the skin tissue. The incorporation of at least one cutting element (cutter) in the system will facilitate removal of the excised tissue by the vacuum subsystem. Alternatively, the cutting element facilitates removal of the cored / excised tissue with the aid of a holding member.

[0600] According to another embodiment of the present invention, once tissue coring has been performed, heat is applied to the treatment area of ​​the skin. The heat may be generated by RF energy, laser, electrical means, and any combination thereof.

[0601] According to another embodiment, the heating element is the same as the coring element. According to another embodiment, the heating element is provided by an optical fiber coupled to a laser source and adapted to apply energy to the treatment tissue after and / or during the coring phase.

[0602] Various modifications and variations of the described methods and systems of the invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention will be apparent to those skilled in medicine, pharmacology, or related fields and are intended to be within the scope of the invention.

Claims

1. A system for directional skin tightening of a skin area, the system comprising: (i) an excision instrument configured to create a plurality of excised tissue portions within an area of ​​skin tissue; (ii) an applicator configured to apply at least one type of energy to the skin area in at least one predetermined direction to provide directional skin tightening within the skin tissue to provide contraction or expansion of the skin area in the predetermined direction; A system comprising:

2. The system of claim 1, further comprising a tensioner configured to apply a stretching tension to the skin area prior to creating multiple excised tissue portions.

3. The system of claim 1, wherein the directional skin tightening is performed in a direction selected from the group consisting of the x direction, the y direction, and / or the z direction, and any combination thereof.

4. The system of claim 1, wherein the ablation device is selected from the group consisting of mechanical means, application of temperature to heat and expel tissue, application of laser, RF, pulsed electromagnetic field, coblation, coagulation, microwave energy, ultrasound, application of any other type of energy, and any combination thereof.

5. The system of claim 1, wherein the applicator is selected from the group consisting of mechanical means, application of temperature to heat and expel tissue, application of laser, RF, pulsed electromagnetic field, coblation, coagulation, microwave energy, ultrasound, application of any other type of energy, and any combination thereof.

6. The system of claim 1, wherein the applicator is configured to apply the at least one type of energy at different intensities, powers, or power densities to each area of ​​the skin tissue.

7. The system of claim 1, wherein the resector is configured to include at least one robotic arm, the at least one robotic arm comprising at least one skin coring device.

8. The system of claim 1, wherein the at least one skin coring instrument comprises at least one selected from the group consisting of at least one needle, at least one punch, and any combination thereof, and the at least one skin coring instrument is configured to contact a surface of the skin to generate a hole in the skin tissue by an excised portion of the skin tissue.

9. The system described in claim 1, wherein at least a portion of the plurality of punches are disposable.

10. The system of claim 1, wherein the multiple punches are adapted to penetrate the skin either simultaneously or sequentially.

11. The system of claim 1, wherein at least one of the following is true: (a) the plurality of punches are characterized by cross-sectional areas that are either similar or substantially different, the cross-sectional areas being selected from the group consisting of circular, rectangular, triangular, hexagonal, elliptical, staggered, parallel, spiral pattern, square or rectangular pattern, radial distribution, and any combination thereof; (b) the plurality of punches are adapted to penetrate to a depth of 1 to 4 mm into the skin; and (c) at least a portion of the plurality of punches are characterized by a radius of 0.15 to 2.0 mm.

12. The system of claim 1, further comprising at least one controller adapted to control positioning of the at least one robotic arm relative to the skin area, further comprising at least one engine adapted to control at least one parameter selected from the group consisting of rotation, translation, penetration angle of the at least one robotic arm relative to the skin, penetration depth, coverage, diameter of at least one excised tissue multiplied by number of cores, different areas of skin to be treated, and any combination thereof, further comprising: the parameters being adjusted manually by an operator or automatically by the controller.

13. The system of claim 1, wherein at least one of the following is true: (a) the rotation is at a speed in the range of 1000 to 7000 RPM and the translation is at a speed in the range of 0 to 500 mm / sec; (c) the translation of the at least one robotic arm relative to the skin changes as the at least one robotic arm approaches the skin; and (d) the rotation of the at least one robotic arm changes as the at least one robotic arm approaches and penetrates the skin; and any combination thereof.

14. The system of claim 1, wherein either (a) each punch of the plurality of punches rotates individually in a predetermined direction at a predetermined speed, or (b) the plurality of punches rotate simultaneously.

15. The system of claim 1, wherein either (a) each punch of the plurality of punches translates individually, or (b) the plurality of punches translate simultaneously.

16. The system of claim 12, wherein the controller includes a stop mechanism adapted to limit the depth to which at least a portion of the plurality of punches penetrate into the skin.

17. The system described in claim 12, wherein the penetration angle is substantially perpendicular to the skin.

18. The system described in claim 12, wherein the controller is adapted to define at least one no-fly zone, the no-fly zone being defined as an area in which the system does not provide any treatment.

19. The system of claim 1, further comprising providing an additive to the skin, the additive being selected from the group consisting of a therapeutic agent, saline growth factor, platelet derived growth factor (PDGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), epidermal growth factor (EGF), and keratinocyte growth factor; one or more stem cells; a steroid, an agent to prevent post-inflammatory skin hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungals; one or more anti-inflammatory agents, or mineralocorticoid agents, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; a foam; or a hydrogel, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, procoagulants, antifibrinolytic agents, one or more procoagulants, one or more anticoagulants, one or more immunomodulators including corticosteroids and nonsteroidal immunomodulators, one or more proteins; or one or more vitamins, and any combination thereof.

20. The system of claim 1, further comprising at least one imaging subsystem adapted to guide the at least one skin coring instrument, the imaging subsystem comprising at least one selected from the group consisting of at least one camera, subcutaneous imaging such as ultrasound-based imaging, OCT, and any combination thereof.

21. The system of claim 1, further comprising at least one subsystem selected from the group consisting of: (a) a vacuum subsystem adapted to apply suction to remove the excised portion of the skin tissue; (b) at least one retainer in communication with at least one of the resecters and adapted to contain the excised tissue to avoid the use of a vacuum; and (c) any combination thereof.

22. The system of claim 1, wherein the skin may be part of a treatment area selected from the group consisting of forehead, cheeks, jawline, neck, upper arms, abdomen, face, eyelids, nose, forehead, chin, forehead, lips, nose, neck, thighs, chest, legs, back, and any combination thereof.

23. 2. The system of claim 1, wherein the system is used for localized removal of excess dermal tissue for skin tightening, at least partial scar removal, skin rejuvenation, at least partial removal of pigment, at least partial tattoo removal, veins, acne, allodynia, age spots, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigines or keratosis, loss of transparency, loss of elasticity, melasma, photodamage, xerosis, fine lines, wrinkles, paleness, scar contracture, scarring, wrinkles, folds, acne scars, pigmentation disorders, striae, surgical scars, cellulite, tattoo removal, malar lines, facial lines, facial folds, skin aging, skin contraction, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangiomas, papules, port wine stains, rosacea, venules reticularis, or telangiectasias, or any other undesirable skin abnormality, and any combination thereof.

24. The system of claim 1, wherein the system utilizes at least one selected from the group consisting of mechanical visualization, OCT, ultrasound, machine learning algorithms, artificial intelligence, image processing, and any combination thereof to efficiently select a preferred location of the tissue to be treated to enhance the outcome of the treatment.

25. The system of claim 1, wherein the skin area is pre-stretched prior to creating the multiple excised tissues.

26. The system described in claim 1, further comprising at least one cutter integrated within the skin coring instrument and adapted to fragment the excised tissue to facilitate its extraction.

27. A segmented coring device for directional skin tightening, comprising: (i) an excision instrument configured to create a plurality of excised tissue portions within an area of ​​skin tissue; (ii) a fastener configured to secure at least a portion of a stretching / compression device having at least two portions adapted to provide contraction or expansion of the area of ​​dermal tissue in at least one predetermined direction to the area of ​​dermal tissue, thereby supporting collagen growth and providing directional skin tightening within the area of ​​dermal tissue; An apparatus comprising:

28. The apparatus of claim 27, wherein the resector is mounted on a computer-controlled robotic arm capable of moving in six or more axes to provide at least six degrees of freedom.

29. The apparatus of claim 27, further comprising a video camera configured to provide visual feedback of at least the micro-coring punch and skin, and a closed-loop force sensor that determines when the punch breaks the skin.

30. The device of claim 27, further comprising a cooler adapted to regulate the temperature of the skin.

31. The apparatus of claim 27, wherein a distal end of the at least one skin coring device further comprises at least one of at least one impedance sensor and at least one temperature sensor, the at least one impedance sensor and the at least one temperature sensor adapted to provide an indication as to the depth of penetration of each of the at least one skin coring device.

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