Methods and instruments for treating 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 of related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 161,471, filed on 16 March 2021, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates to methods and devices for skin treatment. More specifically, the present invention relates to methods and devices for skin coring and tightening, which benefit from achieving skin repair or tightening by supporting collagen proliferation and performing directional skin tightening in the skin tissue. [Background technology]

[0003] Excessive tissue and skin laxity are significant challenges in cosmetic medicine. Many patients currently undergo invasive surgical treatments such as facelifts to treat such conditions. [Overview of the Initiative] [Problems that the invention aims to solve]

[0004] This invention discloses a minimally invasive device for skin tightening. Furthermore, the directional tightening device excises microcores of the skin to achieve a desired aesthetic appearance.

[0005] In cosmetic medicine, the removal of excess tissue and / or skin laxity is a significant challenge affecting over 25% of the U.S. population. While conventional surgical treatments (e.g., facelifts, brow lifts, or breast lifts) can be effective, they are often invasive, inconvenient, and expensive, and scarring limits their applicability.

[0006] It has been shown that removing 5% to 15% of a given area of ​​skin by excising numerous dermal cores less than 1 mm in diameter and applying directional compression elastic bandages results in skin tightening that can be adjusted in the desired direction without (noticeable) scarring. Automated robotic dermal microcoring systems with machine vision and robotic precision can bring high value to clinics in terms of precision, reproducibility, and efficiency.

[0007] Methods using energy sources (e.g., lasers, non-coherent light, radiofrequency, or ultrasound) may be effective in improving skin structure and texture, but are less effective in tightening or reducing skin laxity. Neurotoxins such as botulinum toxin reduce the formation of dynamic wrinkles by paralyzing the injected muscles, but such toxins have little to no effect on firmness or laxity. Finally, dermal fillers such as hyaluronic acid are injected into the dermis to smooth wrinkles and improve contour, 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 fragmentation excision ("RFR") is a procedure that can be used to achieve localized aesthetic contouring by removing loose skin and excess fatty tissue from a patient. The skin can be removed using a rotational microcoring punch, which is a hollow, sharp tube that performs full-thickness dermal excision. Such punches are adapted to treat scars, acne scars, lines, wrinkles, stretch marks, and melanosis, among other conditions, to improve skin texture and tighten the skin. When the punch makes a small hole in the top layer of skin, such a hole triggers the body's healing process, thereby giving such an instrument the opportunity for the treated area to heal with less discoloration and / or deformation as well as greater smoothness on the surface.

[0009] However, such methods are not without their problems, and their effectiveness still needs to be improved. Therefore, there is a need to improve the methods and instruments to enhance the effectiveness of such minimally invasive techniques. Furthermore, there is still a long-awaited 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 specifically, the present invention relates to methods and devices for skin coring and tightening, which benefit from achieving skin repair or tightening by supporting collagen proliferation and performing directional skin tightening in the skin tissue.

[0011] One object of the present invention is a directional skin tightening method, (i) A step of creating multiple excised tissue portions within a region of skin tissue, (ii) The step of attaching to the skin area an extension / compression device having at least two parts, which is fitted to contract or expand the skin area in at least one predetermined direction, (iii) The step of fixing at least a portion of the stretch / compression device to the skin, (iv) A step of applying tension between the two parts to perform directional skin tightening on the skin tissue. The objective is to provide a method that includes this.

[0012] Another object of the present invention is to provide the above-defined method wherein the step of fixing at least a portion of the stretch / compression device to the skin causes the skin area to contract in the predetermined direction.

[0013] Another object of the present invention is to provide the method defined above, further comprising the step of securing the second portion of the stretch / compression device to the skin.

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

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

[0016] Another object of the present invention is to provide the method defined above, wherein the long portion includes at least one adhesive layer adapted to ensure attachment between the short portion and the long portion.

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

[0018] Another object of the present invention is to provide the method defined above, wherein the longer portion comprises Velcro adapted to ensure secure attachment of the shorter portion to the longer portion.

[0019] Another object of the present invention is to provide the method defined above, wherein the shorter portion comprises Velcro adapted to ensure attachment between the shorter portion and the longer portion.

[0020] Another object of the present invention is that the step of applying tension between the two parts is 20 N / mm 2 ~40N / mm 2 The objective is to provide a method defined above for applying force within the specified range.

[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 muscle mass, 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 the step of applying tension between the two parts is performed in a direction selected from the group consisting of the x, y, and / or z directions and any combination thereof with respect to the stretching / compression device and the skin to perform the directional tightening.

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

[0024] Another object of the present invention is to provide a method as defined above, wherein the 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 the stretching / compression device is provided in the 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 a region of skin tissue is performed by a system comprising at least one robotic arm, and the at least one robotic arm comprises at least one skin coring device.

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

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

[0029] Another object of the present invention is that the skin coring device, A microcoring punch containing at least six microcoring needles, A mechanism configured to rotate each microcoring needle about at least one axis of symmetry of each needle, wherein the rotation of each microcoring needle is synchronized with the rotation of the remaining microcoring needles. A mechanism configured to advance a microcoring punch toward the skin and penetrate it to a depth of at least 2 millimeters, A mechanism configured to step a microcoring punch and position the microcoring punch so that two facets of the stepped microcoring punch hexagon traverse two facets of the first microcoring punch hexagon, and The objective is to provide a method as defined above, which includes the following:

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

[0031] Another object of the present invention is to provide the method defined above for a computer-controlled robotic arm to operate a microcoring punch containing five microcoring needles.

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

[0033] Another object of the present invention is to provide the method defined above, wherein five microcoring needles are located at the vertices of a pentagonal pattern.

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

[0035] Another object of the present invention is to provide the method defined above, wherein the rhombuse includes at least two microcoring needles positioned at opposite vertices of the rhombuse.

[0036] Another object of the present invention is to provide the method defined above, wherein 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 the method defined above, in which the rotation of each microcoring needle is synchronized with the rotation of the remaining microcoring needles.

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

[0039] Another object of the present invention is to provide the method defined above, wherein a microcoring punch advances toward the skin and penetrates to a depth of at least 2 millimeters into the skin.

[0040] Another object of the present invention is to provide the method defined above, wherein the mechanism configured to advance and penetrate the microcoring punch toward 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 the method defined above, wherein at least a portion of the at least one punch is disposable.

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

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

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

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

[0046] Another object of the present invention is to provide the method defined above, wherein the cross-sectional area is 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.

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

[0048] Another object of the present invention is to provide the method defined above, wherein the controller comprises 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 the number of cores, different areas of the skin to be treated, and any combination thereof.

[0049] Another object of the present invention is to provide the above-defined method in which the parameters are adjusted manually by an operator or automatically by a controller.

[0050] Another object of the present invention is to provide the above-defined method by which the parameters are adjusted in real time.

[0051] Another object of the present invention is to provide the method defined above, wherein the rotational speed is in the range of 1000 RPM to 7000 RPM, i.e., 3000 RPM to 7000 RPM.

[0052] Another object of the present invention is to provide the above-defined method wherein the translational speed is in the range of 0 mm / sec to 500 mm / sec.

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

[0054] Another object of the present invention is to provide the above-defined method wherein the rotation of the at least one robotic arm changes as the at least one robotic arm approaches and penetrates the skin.

[0055] Another object of the present invention is to provide the above-defined method wherein each of the at least one punches rotates independently in a predetermined direction. It should be emphasized that each of the punches can be rotated in a different direction.

[0056] Another object of the present invention is to provide the above-defined method in which all of the punches rotate simultaneously.

[0057] Another object of the present invention is to provide the above-defined method wherein each of the at least one punches is translated individually.

[0058] Another object of the present invention is to provide the above-defined method in which all of the punches are translated simultaneously.

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

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

[0061] Another object of the present invention is to provide the method defined above, wherein the controller is adapted to define at least one no-fly zone, the no-fly zone being defined as an area not treated by the system.

[0062] Another object of the present invention is to provide the above-defined method by which the system further imparts additives to the skin.

[0063] Another object of the present invention is to provide the method defined above, wherein the additive is selected from the group consisting of therapeutic agents, 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; steroids, agents for preventing post-inflammatory hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungal agents; one or more anti-inflammatory agents, or mineralocorticoids, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; foams; or hydrogels, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, coagulants, 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.

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

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

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

[0067] Another object of the present invention is to provide the method defined above, wherein the skin may be part of a treatment area selected from the group consisting of the forehead, cheeks, jaw contour, neck, upper arms, abdomen, stomach, 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 the methods defined above for use for local 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, blemishes, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigo or keratosis, loss of transparency, loss of elasticity, melanosis, photodamage, psoriasis, fine lines, wrinkles, poor complexion, scar contracture, scarring, wrinkles, folds, acne scars, pigment disorders, striae, surgical scars, cellulite, tattoo removal, cheek wrinkles, facial wrinkles, facial folds, skin aging, skin contracture, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangioma, papules, port-wine stains, rosacea, reticular vein, or telangiectasia, or any other undesirable skin abnormalities and any combination thereof.

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

[0070] Another object of the present invention is to provide the method defined above, wherein the area ratio of the excised tissue portion is less than approximately 70% of the skin area.

[0071] Another object of the present invention is to provide the method defined above, wherein the area ratio of the excised tissue portion is less than approximately 10% of the skin area.

[0072] Another object of the present invention is to provide the method defined above, wherein the area ratio of the excised tissue portion is approximately 5% to approximately 30% of the skin area.

[0073] Another object of the present invention is to provide the method defined above, which includes the step of pre-stretching a skin area before the step of producing a plurality of excised tissues.

[0074] Another object of the present invention is a dermal microcoring method, The steps include providing a microcoring punch containing six microcoring needles, The steps include applying a microcoring punch to at least one segment of skin and performing at least one microcoring process, and A dermal coring method including, The objective is to provide a dermal coring method in which each successive microcoring punch positions the microcoring punch such that at least one facet of the stepped microcoring punch hexagon traverses one facet of the preceding hexagon.

[0075] Another object of the present invention is to provide the method defined above, wherein each successive microcoring punch positions the microcoring punch such that at least two facets of the stepped microcoring punch hexagon traverse two facets of the preceding hexagon.

[0076] Another object of the present invention is to provide the method defined above, wherein each microcoring punch applied to the at least one segment of the skin includes stepping the microcoring punch in at least one of the X and Y directions.

[0077] Another object of the present invention is to provide the method defined above, wherein each successive microcoring punch is stepped by a distance at least equal to the radius of the circle in which the hexagonal pattern is inscribed.

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

[0079] Another object of the present invention is to provide the method defined above for positioning five microcoring needles at the vertices of a pentagonal pattern.

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

[0081] Another object of the present invention is to provide the method defined above, wherein the rhombuse includes at least two microcoring needles positioned at opposite vertices of the rhombuse.

[0082] Another object of the present invention is to provide the method defined above for positioning at least one vortex of a stepped hexagon 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 the method defined above, which, following skin coring, applies positive pressure (compression) to compress the circular holes in order to obtain optimal skin healing and aesthetic skin tightening results.

[0084] Another object of the present invention is to provide the method defined above, wherein the step of rotating each of the microcoring needles is performed about at least one axis of symmetry.

[0085] Another object of the present invention is to provide the method defined above for synchronizing the rotation of each microcoring needle with the rotation of the remaining microcoring needles.

[0086] Another object of the present invention is to provide the method defined above for advancing a microcoring punch toward the skin and penetrating it to a depth of at least 2 millimeters.

[0087] Another object of the present invention is to provide the method defined above for using vacuum to draw an incised skin core into a waste canister via a tube.

[0088] Another object of the present invention is to provide the method defined above for flushing a tube with a liquid to remove a blockage inside the tube.

[0089] Another object of the present invention is to provide the method defined above for aligning punches perpendicular to the skin.

[0090] Another object of the present invention is to provide the method defined above for determining the timing of a punch breaking the skin using a closed-loop force sensor and visual feedback.

[0091] Another object of the present invention is to provide the method defined above for retracting a punch and moving the punch to the next treatment position.

[0092] Another object of the present invention is a dermal microcoring apparatus, A microcoring punch containing six microcoring needles, A mechanism configured to rotate each microcoring needle about at least one axis of symmetry of each needle, wherein the rotation of each microcoring needle is synchronized with the rotation of the remaining microcoring needles. A mechanism configured to advance a microcoring punch toward the skin and penetrate it to a depth of at least 2 millimeters, A mechanism configured to step a microcoring punch and position the microcoring punch such that one facet of the stepped microcoring punch hexagon traverses one facet of the first microcoring punch hexagon, and The objective is to provide a device equipped with [the necessary features / equipment].

[0093] Another object of the present invention is to provide the apparatus defined above, wherein the mechanism is configured to step a microcoring punch and position the microcoring punch such that two facets of the stepped microcoring punch hexagon traverse two facets of a first microcoring punch hexagon.

[0094] Another object of the present invention is to provide the apparatus defined above, wherein a microcoring punch is mounted on a computer-controlled robotic arm that can move in six or more axes (degrees of freedom).

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

[0096] Another object of the present invention is to provide the apparatus defined above, which utilizes six microcoring needles.

[0097] Another object of the present invention is to provide the apparatus defined above, in which the rotation of each microcoring needle is synchronized with the rotation of the remaining microcoring needles.

[0098] Another object of the present invention is to provide the apparatus defined above, wherein the mechanism configured to synchronize the rotation of each microcoring needle with the rotation of the remaining microcoring needles is one of a group of mechanisms consisting of gears or friction belts.

[0099] Another object of the present invention is to provide the apparatus defined above, wherein the steps of the microcoring punch are equal to at least half the radius of the circle in which the hexagon is inscribed.

[0100] Another object of the present invention is to provide the apparatus defined above, wherein the area between two intersecting (transverse) facets of the first hexagon and two facets of the stepped hexagon forms a rhombus.

[0101] Another object of the present invention is to provide the apparatus defined above, wherein the rhombuse includes at least two microcoring needles positioned at opposite vertices of the rhombuse.

[0102] Another object of the present invention is to provide the apparatus defined above, wherein at least one stepped hexagonal vortex 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 the apparatus defined above, further comprising a video camera configured to provide at least a microcoring punch and visual feedback of the skin, and a closed-loop force sensor for determining the timing of the punch piercing the skin.

[0104] Another object of the present invention is to provide the apparatus defined above, wherein a microcoring punch advances toward the skin and penetrates to a depth of at least 2 millimeters.

[0105] Another object of the present invention is to provide the apparatus defined above, wherein the mechanism configured to advance and penetrate the microcoring punch toward 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 the apparatus defined above, wherein the mechanism configured to synchronize the rotation of each microcoring needle with the rotation of the remaining microcoring 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 microcoring holes. The steps include providing a microcoring punch containing five microcoring needles arranged in a pentagonal pattern with a sixth microcoring needle at its center, The steps include applying the microcoring punch to a segment of skin to perform a first microcoring operation, Stepping the aforementioned microcoring punch to treat a second skin segment A method including, The present invention provides a method for positioning a microcoring punch such that each subsequent step of the microcoring punch lies 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 the method defined above for positioning each of the second and subsequent hexagons of a microcoring punch such that two facets of the second and subsequent hexagons traverse two facets of the preceding hexagon.

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

[0110] Another object of the present invention is to provide the method defined above for positioning a second microcoring punch (larger than the first microcoring punch) coaxially with the first microcoring punch.

[0111] Another object of the present invention is an apparatus for dermal microcoring of a single segment of skin area and for directional tightening thereof, A microcoring punch including at least one microcoring needle (preferably five arranged in a pentagonal pattern with a sixth microcoring needle at the center), A mechanism configured to rotate each microcoring needle about at least one axis of symmetry of each needle, wherein the rotation of each microcoring needle is synchronized with the rotation of the remaining microcoring needles. A mechanism configured to step a microcoring punch toward the skin and penetrate it to a depth of at least 2 millimeters, A mechanism configured to step a microcoring punch and position the microcoring punch so that two facets of the stepped microcoring punch hexagon traverse two facets of the first microcoring punch hexagon, and The objective is to provide an apparatus as defined above, which includes the following features.

[0112] Another object of the present invention is to provide the apparatus defined above, wherein the at least one microcoring needle is five microcoring needles.

[0113] Another object of the present invention is to provide the apparatus defined above, wherein a microcoring punch is mounted on a computer-controlled robotic arm that can move in six or more axes (degrees of freedom).

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

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

[0116] Another object of the present invention is to provide the apparatus defined above, wherein five microcoring needles are located at the vertices of a pentagonal pattern.

[0117] Another object of the present invention is to provide the apparatus defined above, wherein the area between two intersecting facets of the first hexagon and two facets of the stepped hexagon forms a rhombus.

[0118] Another object of the present invention is to provide the apparatus defined above, wherein the rhombuse includes at least two microcoring needles positioned at opposite vertices of the rhombuse.

[0119] Another object of the present invention is to provide the apparatus defined above, wherein at least one stepped hexagonal vortex 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 the apparatus defined above, in which the rotation of each microcoring needle is synchronized with the rotation of the remaining microcoring needles.

[0121] Another object of the present invention is to provide the apparatus defined above, wherein the mechanism configured to synchronize the rotation of each microcoring needle with the rotation of the remaining microcoring needles is one of a group of mechanisms consisting of gears or friction belts.

[0122] Another object of the present invention is to provide the apparatus defined above, wherein a microcoring punch advances toward the skin and penetrates to a depth of at least 2 millimeters.

[0123] Furthermore, an object of the present invention is to provide the apparatus defined above, wherein the mechanism configured to advance and penetrate the microcoring punch toward 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 a method for directional skin tightening in a skin region, (i) A step of preparing multiple excised tissue portions in a region of skin tissue, (ii) A step of applying energy to the skin region to contract or expand the skin region in a predetermined direction to perform directional skin tightening in the skin tissue. The objective is to provide a method that includes this.

[0125] Another object of the present invention is to provide the method defined above, further comprising the step of applying stretch tension to the skin region prior to the step of producing a plurality of excised tissue portions.

[0126] Another object of the present invention is to provide the method defined above, 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.

[0127] Another object of the present invention is to provide the method defined above, wherein the step of producing a plurality of excised tissue portions in a region of skin tissue is carried out by means selected from the group consisting of mechanical means, the application of temperature for heating and discharging the tissue, the application of a laser, RF, coagulation, microwave energy, ultrasound, and the application of any other energy, and any combination thereof.

[0128] Another object of the present invention is to provide the method defined above, wherein the step of applying energy to the skin region to contract or expand the skin region is carried out by means selected from the group consisting of mechanical means, temperature application for heating and discharging tissue, laser application, RF, coagulation, microwave energy, ultrasound, and application of any other energy, and any combination thereof.

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

[0130] Another object of the present invention is to provide the method defined above, wherein the at least one skin coring device comprising at least one punch is configured to contact the surface of the skin to create holes in the skin tissue by excised portions of skin tissue.

[0131] Another object of the present invention is to provide the method defined above, wherein the at least one punch comprises at least six punches, five of which are arranged in a pentagonal shape around a sixth central punch.

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

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

[0134] Another object of the present invention is to provide the method defined above, wherein all of the punches are characterized by either similar cross-sectional areas or substantially different cross-sectional areas.

[0135] Another object of the present invention is to provide the method defined above, wherein the plurality of punches are adapted to penetrate the skin to a depth of 1 mm to 4 mm.

[0136] Another object of the present invention is to provide the above-defined method wherein at least one of the punches is characterized by a radius of 0.15 mm to 1.0 mm.

[0137] Another object of the present invention is to provide the method defined above, wherein the cross-sectional area is 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.

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

[0139] Another object of the present invention is to provide the method defined above, wherein the controller comprises 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 the number of cores, different areas of the skin to be treated, and any combination thereof.

[0140] Another object of the present invention is to provide the above-defined method in which the parameters are adjusted manually by an operator or automatically by a controller.

[0141] Another object of the present invention is to provide the above-defined method by which the parameters are adjusted in real time.

[0142] Another object of the present invention is to provide the method defined above, wherein the rotational speed is in the range of 1000 RPM to 7000 RPM.

[0143] Another object of the present invention is to provide the above-defined method wherein the translational speed is in the range of 0 mm / sec to 500 mm / sec.

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

[0145] Another object of the present invention is to provide the above-defined method wherein the rotation of the at least one robotic arm changes as the at least one robotic arm approaches and penetrates the skin.

[0146] Another object of the present invention is to provide the above-defined method, wherein at least one punch rotates independently in a predetermined direction at a predetermined speed.

[0147] Another object of the present invention is to provide the above-defined method in which all of the punches rotate simultaneously.

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

[0149] Another object of the present invention is to provide the above-defined method in which all of the punches are translated simultaneously.

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

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

[0152] Another object of the present invention is to provide the method defined above, wherein the controller is adapted to define at least one non-fly zone, the non-fly zone being defined as an area not treated by the system.

[0153] Another object of the present invention is to provide the above-defined method by which the system further imparts additives to the skin.

[0154] Another object of the present invention is to provide the method defined above, wherein the additive is selected from the group consisting of therapeutic agents, 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; steroids, agents for preventing post-inflammatory hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungal agents; one or more anti-inflammatory agents, or mineralocorticoids, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; foams; or hydrogels, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, coagulants, 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.

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

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

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

[0158] Another object of the present invention is to provide the method defined above, wherein the skin may be part of a treatment area selected from the group consisting of the forehead, cheeks, jaw contour, neck, upper arms, abdomen, stomach, 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 the methods defined above for use for local 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, blemishes, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigo or keratosis, loss of transparency, loss of elasticity, melanosis, photodamage, psoriasis, fine lines, wrinkles, poor complexion, scar contracture, scarring, wrinkles, folds, acne scars, pigment disorders, striae, surgical scars, cellulite, tattoo removal, cheek wrinkles, facial wrinkles, facial folds, skin aging, skin contracture, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangioma, papules, port-wine stains, rosacea, reticular vein, or telangiectasia, or any other undesirable skin abnormalities and any combination thereof.

[0160] Another object of the present invention is to provide the method defined above, in which 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 tissue to be treated and enhance the outcome of the treatment.

[0161] Another object of the present invention is to provide the method defined above, wherein the area ratio of the excised tissue portion is approximately 5% to approximately 30% of the skin area.

[0162] Another object of the present invention is to provide the method defined above, wherein the area ratio of the excised tissue portion is less than approximately 10% of the skin area.

[0163] Another object of the present invention is to provide the method defined above, which includes the step of pre-stretching a skin area before the step of producing a plurality of excised tissues.

[0164] Another object of the present invention is a directional skin tightening system for the skin region, (i) Means for producing multiple excised tissue portions in a region of skin tissue, (ii) means for applying at least one type of energy to the skin region to contract or expand the skin region in a predetermined direction to perform directional skin tightening in the skin tissue; The objective is to provide a system that includes these features.

[0165] Another object of the present invention is to provide the method defined above, further comprising means for applying stretch tension to the skin region prior to the step of producing a plurality of excised tissue portions.

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

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

[0168] Another object of the present invention is to provide the system defined above, wherein the means for applying energy to the skin region to contract or expand the skin region comprises means selected from the group consisting of mechanical means, temperature application for heating and discharging tissue, laser application, RF, 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 the above-defined system wherein the means for producing a plurality of excised tissue portions in a region of skin tissue comprises a system comprising at least one robotic arm, and the at least one robotic arm comprises at least one skin coring device.

[0170] Another object of the present invention is to provide the system 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 in order to create holes in the skin tissue by the excised portion of the skin tissue.

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

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

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

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

[0175] Another object of the present invention is to provide the system defined above, wherein the plurality of punches are adapted to penetrate the skin to a depth of 1 mm to 4 mm.

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

[0177] Another object of the present invention is to provide the system defined above, wherein the cross-sectional area is 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.

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

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

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

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

[0182] Another object of the present invention is to provide the above-defined system, wherein the rotational speed is in the range of 1000 RPM to 7000 RPM.

[0183] Another object of the present invention is to provide the above-defined system, wherein the translational speed is in the range of 0 mm / sec to 500 mm / sec.

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

[0185] Another object of the present invention is to provide the above-defined system wherein the rotation of the at least one robotic arm changes as the at least one robotic arm approaches and penetrates the skin.

[0186] Another object of the present invention is to provide the above-defined system in which each of the plurality of punches rotates individually in a predetermined direction at a predetermined speed.

[0187] Another object of the present invention is to provide the system defined above in which the plurality of punches rotate simultaneously.

[0188] Another object of the present invention is to provide the above-defined system in which each of the plurality of punches translates individually.

[0189] Another object of the present invention is to provide the system defined above in which the multiple punches are translated simultaneously.

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

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

[0192] Another object of the present invention is to provide the system defined above, wherein the controller is adapted to define at least one non-fly zone, the non-fly zone being defined as an area not treated by the system.

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

[0194] Another object of the present invention is to provide a system as defined above, wherein the additive is selected from the group consisting of therapeutic agents, 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; steroids, agents for preventing post-inflammatory hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungal agents; one or more anti-inflammatory agents, or mineralocorticoids, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; foams; or hydrogels, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, coagulants, 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 the system defined above, further comprising at least one imaging subsystem adapted to guide the at least one skin coring device.

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

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

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

[0199] Another object of the present invention is to provide the above-defined system for use for local 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, blemishes, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigo or keratosis, loss of translucency, loss of elasticity, melanosis, photodamage, psoriasis, fine lines, wrinkles, poor complexion, scar contracture, scarring, wrinkles, folds, acne scars, pigment disorders, striae, surgical scars, cellulite, tattoo removal, cheek wrinkles, facial wrinkles, facial folds, skin aging, skin contracture, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangioma, papules, port-wine stains, rosacea, reticular vein, or telangiectasia, or any other undesirable skin abnormalities and any combination thereof.

[0200] Another object of the present invention is to provide the above-defined system that 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 tissue to be treated and thereby enhance the outcome of the treatment.

[0201] Another object of the present invention is to provide the system defined above, wherein the area ratio of the excised tissue portion is approximately 5% to approximately 30% of the skin area.

[0202] Another object of the present invention is to provide the system defined above, wherein the area ratio of the excised tissue portion is less than approximately 10% of the skin area.

[0203] Another object of the present invention is to provide the system defined above, which includes pre-stretching a skin region before producing multiple excised tissues.

[0204] Another object of the present invention is to provide the method defined above, further comprising the step of providing the system with at least one cutting element adapted to crush the excised tissue in order to facilitate the removal of the excised tissue.

[0205] Another object of the present invention is to provide the method defined above, further comprising the step of providing the system with at least one cutting element adapted to crush the excised tissue in order to facilitate the removal of the excised tissue.

[0206] Another object of the present invention is to provide the method defined above, further comprising the step of providing the system with at least one cutting element adapted to crush the excised tissue in order to facilitate the removal of the excised tissue.

[0207] Another object of the present invention is to provide the method defined above, further comprising the step of providing the system with at least one cutting element adapted to crush the excised tissue in order to facilitate the removal of the excised tissue.

[0208] Another object of the present invention is to provide the method defined above, further comprising the step of providing the system with at least one cutting element adapted to crush the excised tissue in order to facilitate the removal of the excised tissue.

[0209] Another object of the present invention is to provide the apparatus defined above, further comprising at least one cutting element incorporated within the skin coring device and adapted to crush the excised tissue in order to facilitate the extraction of the excised tissue.

[0210] Another object of the present invention is to provide the apparatus defined above, further comprising at least one cutting element incorporated within the skin coring device and adapted to crush the excised tissue in order to facilitate the extraction of the excised tissue.

[0211] Another object of the present invention is to provide the apparatus defined above, further comprising at least one cutting element incorporated within the skin coring device and adapted to crush the excised tissue in order to facilitate the extraction of the excised tissue.

[0212] Another object of the present invention is to provide the system defined above, further comprising at least one cutting element incorporated within the skin coring device and adapted to crush the excised tissue in order to facilitate the extraction of the excised tissue.

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

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

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

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

[0217] Another object of the present invention is to provide the method defined above, wherein the dynamic magnetic field pulse is generated by at least one coil.

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

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

[0220] Another object of the present invention is to provide the above-defined method by which the RF energy is applied to the skin in the form of heat.

[0221] Another object of the present invention is that (a) the shape of the electromagnetic pulse is 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) the 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) the 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) the 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) the 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 The objective is to provide the above-defined method, wherein (g) the energy E applied by the pulse of the frequency generator is in the range of about 1 watt / pulse to about 150 watts / pulse and any combination thereof; (h) the frequency F applied by the pulse applied by the step of applying pulsed electromagnetic wave therapy to the region is in the range of about 1 Hz to about 1 MHz; (i) the frequency F applied by the electromagnetic field pulse is in the range of 1 Hz to 50 Hz; (j) the frequency of the RF energy is in the range of 200 kHz to 40 MHz; and (j) the power P applied by the RF energy pulse is an RMS average power of 1 W to 100 W, and at least one of any combination thereof holds true.

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

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

[0224] Another object of the present invention is to provide the method defined above, wherein the distal end of the 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 the method defined above, wherein 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 index of the depth of penetration of each of the at least one skin coring device.

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

[0227] Another object of the present invention is to provide the method defined above, wherein the 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 a segmented coring device for directional skin tightening, (i) Means for producing multiple excised tissue portions in a region of skin tissue, (ii) means for securing to the skin area an extension / compression device having at least two parts, which is adapted to contract or expand the skin area in at least one predetermined direction, The objective is to provide a device that supports collagen proliferation and performs directional skin tightening in the skin tissue.

[0229] Another object of the present invention is to provide the above-defined device, wherein the extension / compression device comprises a long portion and a short portion, the short portion comprising at least one buckle-like element having at least one slotted hole, and further adapted to be physically in communication with the short portion by passing the long portion through the at least one slotted hole and securing it to the short portion.

[0230] Another object of the present invention is to provide the apparatus defined above, wherein the long portion includes at least one adhesive layer adapted to ensure attachment between the short portion and the long portion.

[0231] Another object of the present invention is to provide the apparatus defined above, wherein the short portion includes at least one adhesive layer adapted to ensure attachment between the short portion and the long portion.

[0232] Another object of the present invention is to provide the above-defined device wherein the longer portion comprises Velcro adapted to ensure secure attachment of the shorter portion to the longer portion.

[0233] Another object of the present invention is to provide the above-defined device wherein the shorter portion comprises Velcro adapted to ensure secure attachment between the shorter portion and the longer portion.

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

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

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

[0237] Another object of the present invention is to provide the apparatus defined above, wherein the step of producing a plurality of excised tissue portions in a region of skin tissue is carried out by means selected from the group consisting of mechanical means, the application of temperature for heating and discharging tissue, the application of a laser, a pulsed electromagnetic field, RF, coagulation, coagulation, microwave energy, ultrasound, and the application of any other type of energy, and any combination thereof.

[0238] Another object of the present invention is to provide the apparatus defined above, wherein the step of producing a plurality of excised tissue portions in a region of skin tissue is performed by a system comprising at least one robotic arm, and the at least one robotic arm comprises at least one skin coring device.

[0239] Another object of the present invention is to provide the apparatus defined above, wherein the at least one skin coring apparatus 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 apparatus is configured to contact the surface of the skin to create holes in the skin tissue by the excised portion of the skin tissue.

[0240] Another object of the present invention is to provide the above-defined apparatus, wherein the at least one skin coring apparatus comprises at least six punches, five of which are arranged in a pentagonal shape around a sixth central punch.

[0241] Another object of the present invention is to provide the apparatus defined above, wherein at least a portion of the at least one punch is disposable.

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

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

[0244] Another object of the present invention is to provide the above-defined apparatus, wherein the at least one skin coring device is adapted to penetrate the skin to a depth of 1 mm to 4 mm.

[0245] Another object of the present invention is to provide the above-defined apparatus, wherein the at least one skin coring device is characterized by a radius of 0.15 mm to 1.0 mm.

[0246] Another object of the present invention is to provide the apparatus defined above, wherein the cross-sectional area is 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.

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

[0248] Another object of the present invention is to provide the apparatus defined above, wherein the controller comprises 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 the number of cores, different areas of the skin being treated, and any combination thereof.

[0249] Another object of the present invention is to provide the apparatus defined above, wherein the parameters are manually adjusted by an operator or automatically adjusted by a controller.

[0250] Another object of the present invention is to provide the apparatus defined above, in which the parameters are adjusted in real time.

[0251] Another object of the present invention is to provide the above-defined apparatus, wherein the rotational speed is in the range of 1000 RPM to 7000 RPM.

[0252] Another object of the present invention is to provide the above-defined apparatus, wherein the translational speed is in the range of 0 mm / sec to 500 mm / sec.

[0253] Another object of the present invention is to provide the above-defined apparatus wherein the translation of the at least one robotic arm relative to the skin changes as the at least one robotic arm approaches the skin.

[0254] Another object of the present invention is to provide the apparatus defined above, wherein the rotation of the at least one robotic arm changes as the at least one robotic arm approaches and penetrates the skin.

[0255] Another object of the present invention is to provide the above-defined apparatus, wherein each of the at least one skin coring device rotates independently in a predetermined direction at a predetermined speed.

[0256] Another object of the present invention is to provide the above-defined apparatus in which at least two of the skin coring devices rotate simultaneously.

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

[0258] Another object of the present invention is to provide an apparatus as defined above, wherein at least two of the at least one skin coring devices are translated simultaneously.

[0259] Another object of the present invention is to provide an apparatus as defined above, wherein the distance between each pair of adjacent skin coring devices is adjustable and can be changed before or during treatment.

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

[0261] Another object of the present invention is to provide the apparatus defined above, wherein the penetration angle is substantially perpendicular to the skin.

[0262] Another object of the present invention is to provide the apparatus defined above, wherein the controller is adapted to define at least one non-fly zone, the non-fly zone being defined as an area not treated by the system.

[0263] Another object of the present invention is that the skin coring device, A microcoring punch including at least five microcoring needles arranged in a predetermined pattern centered on a sixth microcoring needle, A mechanism configured to rotate each microcoring needle about at least one axis of symmetry of each needle, wherein the rotation of each microcoring needle is synchronized with the rotation of the remaining microcoring needles. A mechanism configured to step a microcoring punch toward the skin and penetrate it to a depth of at least 2 millimeters, A mechanism configured to step a microcoring punch and position the microcoring punch such that at least one element selected from the group consisting of vertices, facets, and combinations thereof of the stepped microcoring punch hexagon traverses at least one element selected from the group consisting of vertices, facets, and combinations thereof of the preceding microcoring punch hexagon, and The objective is to provide the apparatus defined above, which includes the above.

[0264] Another object of the present invention is to provide the apparatus defined above, wherein a microcoring punch is mounted on a computer-controlled robotic arm that can move in six or more axes (degrees of freedom).

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

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

[0267] Another object of the present invention is to provide the apparatus defined above, wherein five microcoring needles are located at the vertices of a pentagonal pattern.

[0268] Another object of the present invention is to provide the apparatus defined above, wherein the area between two intersecting facets of the first hexagon and two facets of the stepped hexagon forms a rhombus.

[0269] Another object of the present invention is to provide the apparatus defined above, wherein the rhombuse includes at least two microcoring needles positioned at opposite vertices of the rhombuse.

[0270] Another object of the present invention is to provide the apparatus defined above, wherein at least one stepped hexagonal vortex 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 the apparatus defined above, in which the rotation of each microcoring needle is synchronized with the rotation of the remaining microcoring needles.

[0272] Another object of the present invention is to provide the apparatus defined above, wherein the mechanism configured to synchronize the rotation of each microcoring needle with the rotation of the remaining microcoring needles is one of a group of mechanisms consisting of gears or friction belts.

[0273] Another object of the present invention is to provide the apparatus defined above, wherein a microcoring needle advances toward the skin and penetrates to a depth of at least 2 millimeters into the skin.

[0274] Another object of the present invention is to provide the apparatus defined above, wherein the mechanism configured to advance a microcoring needle toward and penetrate the skin is one of a group of mechanisms consisting of a robotic arm or a screw. Such advancement is achieved, for example, by a conveyor such as a belt.

[0275] Another object of the present invention is to provide the apparatus defined above, wherein the system further imparts additives to the skin.

[0276] Another object of the present invention is that the additive is a therapeutic agent, physiological 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; steroids, agents for preventing post-inflammatory skin hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungal agents; one or more anti-inflammatory agents, or mineralocorticoid agents, immune-selective anti-inflammatory derivatives; one or more antibacterial agents; foams; or hydrogels, one or more disinfectants, one or more antiproliferative agents, one or more skin emollients; one or more hemostatic agents, prothrombin, antifibrinolytics, one or more blood coagulation accelerators, one or more anticoagulants, one or more immunomodulatory agents including corticosteroids and non-steroidal immunomodulatory drugs, one or more proteins; or one or more vitamins and any combination thereof, and to provide the device defined above.

[0277] Another object of the present invention is to provide the device defined above, wherein the system further comprises at least one imaging subsystem adapted to induce the at least one skin coring device.

[0278] Another object of the present invention is to provide the device defined above, wherein the 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 the device defined above, wherein the system further comprises at least one vacuum subsystem adapted to perform suction to remove the excised portion of the skin tissue.

[0280] Another object of the present invention is to provide the device defined above, wherein the skin can be a part of the treatment area selected from the group consisting of the forehead, cheeks, jawline, neck, upper arms, abdomen, belly, 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 the device defined above for local 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, alodinia, stains, atopic dermatitis, hyperpigmentation, hyperplasia, freckles or keratosis, loss of translucency, loss of elasticity, melasma, photoaging, psoriasis, fine wrinkles, wrinkles, poor complexion, scar contracture, scarring, wrinkles, folds, acne scars, dyschromia, streaks, surgical scars, cellulite, tattoo removal, cheek wrinkles, facial wrinkles, facial folds, skin aging, skin shrinkage, skin inflammation / allergy, skin relaxation, streaks, vascular lesions, angioma, erythema, hemangioma, papules, port-wine stains, rosacea, telangiectasia, or any other undesirable skin abnormalities and any combination thereof.

[0282] Another object of the present invention is to provide the device defined above that efficiently selects the preferred location of the tissue to be treated using 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 enhance the outcome of the treatment.

[0283] Another object of the present invention is to provide the device defined above, wherein the area ratio of the excised tissue part is about 5% to about 30% of the skin area.

[0284] Another object of the present invention is to provide the device defined above, wherein the area ratio of the excised tissue part is less than about 10% of the skin area.

[0285] Another object of the present invention is to provide the apparatus defined above, further comprising at least one cutting element adapted to crush the excised tissue in order to facilitate the removal of the excised tissue.

[0286] Another object of the present invention is to provide the above-defined apparatus, wherein the at least one skin coring device communicates with at least one RF generator adapted to apply RF energy to the skin and tissue for tissue fragmentation ablation / coagulation.

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

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

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

[0290] Another object of the present invention is to provide the apparatus defined above, wherein the dynamic magnetic field pulse is generated by at least one coil.

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

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

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

[0294] Another object of the present invention is that (a) the shape of the electromagnetic pulse is 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) the 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) the 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) the 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) the 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 The objective is to provide the above-defined apparatus, wherein (g) the energy E applied by the pulses of the number generator is in the range of approximately 1 watt / pulse to approximately 150 watts / pulse or any combination thereof; (h) the frequency F applied by the pulses applied by the step of applying pulsed electromagnetic wave therapy to the region is in the range of approximately 1 Hz to approximately 40 MHz; (i) the frequency F applied by the electromagnetic field pulse is in the range of 1 Hz to 50 Hz; (j) the frequency of the RF energy pulse is in the range of 200 kHz to 10 MHz; and at least one of the RMS average powers of 1 W to 100 W is satisfied.

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

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

[0297] Another object of the present invention is to provide an apparatus as defined above, wherein the distal end of the at least one skin core drilling 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 an apparatus as defined above, wherein the 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 of the depth of penetration of each of the at least one skin core drilling device.

[0299] Another object of the present invention is to provide an apparatus as defined above, wherein the at least one skin core drilling device further comprises at least one needle adapted to inject at least one therapeutic substance into the treatment area.

[0300] Another object of the present invention is to provide an apparatus as defined above, wherein the 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] It is a diagram showing the normal operation of the instrument of the present invention. [Figure 2] It is a diagram showing a dermal microcore drilling process using a single punch. [Figure 3A] It is a diagram showing two possible punch rotation drive methods of belt drive and friction drive. [Figure 3B] It is a diagram showing two possible punch rotation drive methods of belt drive and friction drive. [Figure 3C] It is a diagram showing two possible punch rotation drive methods of belt drive and friction drive. [Figure 3D]This figure shows two possible punch rotation drive systems: belt drive and friction drive. [Figure 3E] This figure shows two possible punch rotation drive systems: belt drive and friction drive. [Figure 4] This figure shows how the skin cores cut from each punch are sucked out by a vacuum. [Figure 5A] This figure shows a single arm that utilizes one or more punches, as embodied within the system. [Figure 5B] This figure shows a single arm that utilizes one or more punches, as embodied within the system. [Figure 6] This is a top view of a punch. The diagram depicts a coaxial punch. [Figure 7] This figure shows a single device design configured to distribute punches and enable overlapping patterns. [Figure 8] This figure shows a single device design configured to distribute punches and enable overlapping patterns. [Figure 9] This figure shows a single device design configured to distribute punches and enable overlapping patterns. [Figure 10A] This figure shows one embodiment of an extension / compression device. [Figure 10B] This figure shows one embodiment of an extension / compression device. [Figure 11] This figure shows the shorter side of this embodiment of the extension / compression device. [Figure 12] This figure shows the shorter side of this embodiment of the extension / compression device. [Figure 13] This figure shows the long side of this embodiment of the extension / compression device. [Figure 14] This figure shows the long side of this embodiment of the extension / compression device. [Figure 15A] This figure shows another embodiment of the directional tightening method and apparatus according to the present invention. [Figure 15B] This figure shows another embodiment of the directional tightening method and apparatus according to the present invention. [Figure 15C] This figure shows another embodiment of the directional tightening method and apparatus according to the present invention. [Figure 15D] This figure shows another embodiment of the directional tightening method and apparatus according to the present invention. [Figure 16] This figure shows another embodiment of the directional tightening method and apparatus according to the present invention. [Figure 17] This figure shows the histological analysis of tissue sections 0, 2, and 5 weeks after fractional coring (tissue removal) treatment. [Figure 18] These are side and longitudinal cross-sectional views of a biological unit removal tool having an internal claw-shaped movable retaining member (retainer or retaining element) in a retracted or unextended state. [Figure 19] Figures 18A and 18B show a side view and a longitudinal cross-sectional view of the biological unit removal tool in its retained state. [Modes for carrying out the invention]

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

[0303] The instrument of the present invention excises a pattern of small dermal cores at a desired density and direction. The holes remaining in the skin are then closed in one direction using a manual compression method such as compression tape or adhesive.

[0304] According to one embodiment of the present invention, the device is designed to remove microcores of the skin in segments for different conditions (e.g., skin resurfacing / wrinkling / lifting).

[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 maximum diameter of 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 of the treatment area. The present invention further relates to methods and instruments for skin treatment. More specifically, the present invention relates to methods and instruments for skin coring and tightening which benefit from achieving skin repair or tightening by supporting (e.g., promoting) collagen proliferation in a given direction and performing directional skin tightening in the skin tissue. The instruments can be used in a wide variety of fields, such as skin laxity, skin resurfacing, treatment of cheek wrinkles, treatment of wrinkles, treatment of folds, removal of acne scars, treatment of pigment disorders, treatment of striae, removal of surgical scars, treatment of cellulite, tattoo removal, and any combination thereof.

[0306] In certain embodiments, the present invention offers one or more of the following advantages. First, the methods and devices herein allow for real-time visualization of results during the course of treatment. It may be envisioned that feedback be sought from the patient in real time during treatment, and that the tightening be adjusted to the patient's preference. Second, the methods and devices herein are adjustable, thereby allowing for titration of tightening after surgical hole or slit formation. For example, the adjustable or high-performance dressings described herein allow for adjustment of tightening intensity, direction, and spatial distribution after the dressing has been applied to or attached to the patient's skin. In another example, titrable tightening may be achieved by selectively closing or opening a subset of slits or holes created in an array. Third, the methods and devices herein require less skill than a surgeon. It may be envisioned that patients be treated in an outpatient setting rather than requiring an inpatient surgical setting. Fourth, the methods and instruments described herein constitute minimally invasive techniques, which 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 instruments described herein may enable a less differentiated method for treating skin by forming holes or slits, because the methods and instruments of the present invention allow for more differentiated control over closing such holes or slits. Sixth, the methods and instruments described herein can rapidly close holes or slits after treating the skin (e.g., within seconds, such as within 10 seconds), thereby minimizing the degree of bleeding and / or coagulation within the holes or slits.Finally, the methods and apparatus described herein may be useful for maximizing the tightening effect while minimizing the healing time by optimizing the tightening (for example, by controlling the degree of skin folds, for example, by increasing the degree of skin folds for some applications or skin areas, and by decreasing the degree of skin folds for other applications or skin areas, as described herein). definition

[0307] In the following, the term "approximately" refers to + / - 25% of any listed value.

[0308] In the following, the term "overlap" refers to vertices, facets, cross-sectional areas, and any combination thereof.

[0309] The term "Optical Coherence Tomography (OCT)" hereafter refers to non-invasive imaging. In other words, OCT is an imaging technique that uses low-coherence light to capture two-dimensional and three-dimensional images with micrometer resolution from within a light-scattering medium (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, which typically uses near-infrared light. By using light with relatively long wavelengths, the light can penetrate into the scattering medium. Another optical technique, confocal microscopy, typically does not penetrate as deeply into the sample but has higher resolution.

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

[0311] The terms “incised” tissue portion or “incision” mean, hereafter, cutting, peeling, or ablation of tissue, including a tissue portion in a skin area, or the act of cutting, peeling, destroying, or ablating tissue, a skin area, or one or more tissue portions. For example, incision includes any cutting, peeling, or ablation into tissue that destroys the tissue or a portion thereof, thereby creating one or more holes or slits in a skin area. Exemplary methods for forming an incised tissue portion or incision include the use of one or more blades, one or more solid needles, fractionated laser ablation, fractionated radiofrequency ablation, coblation, coagulation, microwave energy, and / or fractionated ultrasonic ablation, any useful tool for forming an incision, or any method and apparatus described herein.

[0312] The term “excised” or “excision” hereafter refers to the removed tissue, including a tissue portion from a skin area, or the act of removing tissue or one or more tissue portions from a skin area. Excision usually means “surgically removing.” The term is often used in reference to the removal of a mass, and excision means that tissue is removed using a surgical scalpel, laser, coagulation, ablation, ultrasound, microwave energy, RF, application of heat (to vaporize the skin portion), a mechanical applicator that removes the excised skin portion while “making a hole” in the skin and simultaneously performing suction (during or after making a hole), or any other device. For example, an excision includes any tissue or tissue portion removed from a skin area, which may form an excised tissue portion having a specific geometric shape (e.g., cylindrical, rectangular, triangular, or any shape) and may create one or more holes (i.e., negative space created by the removal of tissue) in the skin area. Exemplary methods for forming an excised tissue portion or excision include the use of one or more hollow needles (optionally including one or more notches, extensions, projections, and / or barbs), one or more microaugers, one or more microabladders, any ablation means that can be used for incision and excision (including, for example, an ablation laser), any useful tool for forming an excision, or any method and apparatus described herein.

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

[0314] In this context, the term "application of expansion force" refers to a physical change in a compressed tape (as disclosed below). In this case, the applied force is an expansion force that stretches the tape.

[0315] The present invention features a method and apparatus for tightening skin in one direction after skin coring (i.e., having one or more incisions or excised tissue portions). In particular, exemplary apparatuses include using compression tape to selectively open or close holes and / or slits.

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

[0317] The device performs a dermal microcoring approach for skin tightening. The device excises a predetermined pattern of small dermal cores at a desired density and direction. The remaining holes in the skin are closed in one direction using a manual compression method such as compression tape or adhesive.

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

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

[0320] The device may include the following elements: (1) At least one robotic arm and controller for controlling the positioning of the arm relative to the skin area to be treated. (2) Skin coring equipment and control devices. (3) An RTC (Real-Time Controller) unit including at least one engine (e.g., a motor or robotic servo motor) that controls the rotation, translation, and orientation of the robotic arm relative to the skin area being treated. (4) An imaging subsystem for analyzing the treatment area and guiding the coring equipment. (5) A vacuum subsystem that performs suction to remove tissue excised from the skin after incision. Alternatively, a retainer is used to hold the excised tissue, making the vacuum subsystem unnecessary. Thus, vacuum is avoided and made unnecessary by such embodiments. (6) A stretch / compression device that allows for compression of the skin (e.g., compression tape).

[0321] Skin coring devices include coring punches (e.g., microneedles), i.e., single or multiple punch arrays for coring the skin simultaneously or sequentially. It should be noted that the coring punches may be at least partially disposable.

[0322] According to one embodiment of the present invention, the coring device is a mechanical device that enables 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 also within the scope of the present invention. For example, circular, rectangular, triangular, hexagonal, elliptical, staggered, parallel, spiral patterns, square or rectangular patterns, radial distributions, and any combination thereof are also within the scope of the present invention.

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

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

[0325] According to one embodiment, the dermal punch has a stopper mechanism for limiting the coring depth. Typical coring depths can be configured in 0.5 mm steps from 1 mm to 6 mm (more specifically from 1 mm to 4 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 1000 RPM to 7000 RPM.

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

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

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

[0331] According to one embodiment, the mechanical extraction speed is one cycle or more per second.

[0332] According to one embodiment, the punch is rinsed with saline solution. It should be noted that the saline solution is used via the punch to rinse it between coring steps, as well as to reduce friction between the cored tissue and the internal parts of the punch during core removal.

[0333] The imaging subsystem includes illumination means (e.g., emitters such as LEDs) for illuminating the imaging subsystem's field of view and maintaining low latency for the imaging subsystem's camera exposure time.

[0334] The wavelength of LEDs is longer than 600nm (warm white) to allow sufficient light to be reflected from the skin to the camera. Shorter wavelengths tend to be absorbed more by human skin, resulting in darker images.

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

[0336] After the coring process, the skin is pulled together by a stretch / compression device (as described below) to promote healing for each stretched / compressed tissue core. According to one embodiment, the stretch / compression device is an adhesive base (e.g., surgical wound closure tape or adhesive). It should be 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 stretching / compressing device is 20 N / mm 2 ~40N / mm 2 It must be due to the tensile force.

[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. • Align the surgical area with the non-fly zone, which is not treated in the aforementioned area of ​​skin tissue. • Allocate areas with different densities. • Assign different hole patterns to different areas • Assign punch depth

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

[0340] Referring to Figure 1, Figure 1 is a diagram showing 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 an adhesive biocompatible criterion marker visual identifier.

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

[0343] It should be noted that administering a local anesthetic to the patient to avoid pain during the procedure is optional.

[0344] In the case of treating folded skin, the operator may stretch the treatment area by applying an adhesive stretch tape. The adhesive tape (e.g., Tegaderm) applies tension to the skin by pulling it apart in the desired direction. It should be noted that it is important to stretch the skin first and only then excise the tissue portion. Otherwise, the skin, due to its flexibility, may become trapped in the internal area within the perforating means (punch and / or needle). Thus, according to one embodiment, a method of directional skin tightening by fractional treatment is, (i) A step of preparing multiple excised tissue portions in a region of skin tissue, (ii) The step of fixing at least one portion of an extension / compression device (e.g., adhesive tape Tegaderm) having at least two parts, which is adapted to contract or expand the skin area in at least one predetermined direction, to the skin area; (iii) A step of applying tension between the two portions to support collagen proliferation and to perform directional skin tightening in the region of skin tissue. It is done by [the specified method].

[0345] As disclosed above, in some cases (for example, in the case of lax skin), the step of fixing the stretch / compression device to the skin area and applying tension (either stretch or compression) to the skin is performed before the step of creating multiple excised tissue portions in a region of skin tissue. This is to prevent lax skin from being trapped inside the perforation means (punch and / or needle).

[0346] According to another embodiment, the stretch / compression device is first stretched or compressed, and only thereafter is the second portion of the stretch / compression device fixed to different areas of the skin.

[0347] According to another embodiment, the second portion of the stretching / compressing device is fixed to different areas of the skin.

[0348] According to another embodiment, the step of applying tension between the two parts further includes the step of fixing the second part of the stretch / compression device to the skin and pulling one part relative to the other. As described above, once the two parts of the stretch / compression device are first fixed to the skin and stretched, it is within the scope of the present invention that the perforating means (punch or needle) can then produce multiple excised tissue portions.

[0349] Even if the operator initially applies tension between the two parts of the stretch / compression device and then subsequently (while tension is applied to the skin) creates multiple excision tissue portions in a region of skin tissue, it should be noted that the operator may need to apply additional tension between the two parts of the stretch / compression device after creating the excision tissue portions.

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

[0351] Step 101 of the next steps is to place the disposable punch (and / or needle) on the instrument. The desired punch (and / or needle) is selected for the hold position. The desired density and penetration depth.

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

[0353] A stopper is optionally installed to limit the maximum coring depth to 1mm to 4mm.

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

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

[0356] Subsequently, or simultaneously with coring, the excised tissue is removed by vacuum. It should be noted that the system can utilize a perforating means that ejects the skin plug simultaneously with perforation, and therefore a vacuum means is not required. In that case, at least one retaining element incorporated into the perforating means (punch) is configured to hold the excised tissue (similar to forceps), eliminating the need for a vacuum subsystem. Thus, simultaneously with perforation by the perforating means (punch) performed on the skin, the retaining element accumulates and holds the excised skin plug (tissue). Therefore, since the main principle of suction is to eject the excised skin plug (tissue), there is no need to perform suction. In particular, at least one retaining device may be implemented as a forceps-like instrument configured to apply pressure to hold the tissue.

[0357] Exemplary embodiments of the retaining element are shown in Figures 18A and 18B, which are side and longitudinal cross-sectional views, respectively, of a biological unit removal tool having an internal claw-shaped movable retaining member in a retracted or unextended state. Figures 19A and 19B show the removal tool in a retained or extended state. Figures 18A, 18B, 19A, and 19D are illustrations illustrating an example described in U.S. Patent No. 8,696,686, issued April 15, 2014, the entire contents thereof, including the apparatus and method disclosed herein, are incorporated by reference. The exemplary removal tool 640 in 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, the inner tube or inner member having a plurality of movable members or deformable claws 646 attached to the inner tube. In the retracted position, the deformable claw 646 is coplanar with the inner diameter of the outer tube 642 and attached to the distal end of the inner tube 644, and the inner tube is capable of moving proximal / distal relative to the distal tip 643 of the outer tube. The distal tip 643 has a structure 645 that influences or guides the deformable claw to converge. The structure 645 is configured to take the form of an internal ridge that guides the claw inward as the inner tube advances distally so that the claw converges. Alternatively, the structure may take the form of a tapered, stepped, inclined, or any other form that guides the deformable claw to join. In the retaining position, at least a portion of the retaining member, e.g., the deformable claw, extends beyond the distal tip of the outer elongated member 642. The inner tube with claws can be made of a variety of materials, including shape memory materials such as Nitinol, Elgiloy, or cobalt-chromium, or similar materials that, if necessary, adapt to repeated bending without fatigue (or in a form with better fatigue resistance) at the base of the claws. In some embodiments, the movable retaining member does not have to be claw-shaped and may be, for example, a thin wire, filament, or paddle-shaped structure, or in various shapes and surface finishes, as well as various circumferential distributions.

[0358] Punching tools (punches, microneedles) generally have a tubular, elongated body with a cylindrical contour and a hollow lumen penetrating the body. According to one embodiment, at least one retaining member described herein may be positioned not only at the distal portion of the punching tool but also at various positions along the body of the punching tool, for example, at a short distance from the distal end or in the middle along the body of the punching tool, depending on the structure of the punching tool and its intended purpose. As used herein, the terms “joined,” “attached,” “connected,” or “mounted” may mean joined, attached, incorporated, or mounted directly or indirectly through one or more intervening members.

[0359] As used herein, “retaining member” refers to a structure or mechanism, or several structures and / or mechanisms, that partially or completely retain biological tissue within the lumen of a perforating means. The retaining member may translate into or across the lumen, or circumferentially contract the lumen to improve its retention and removal, for example, by simply tightening around the tissue located within the lumen. The retaining members described herein may be made of a variety of biocompatible materials, such as polypropylene, polyester, polyurethane, Teflon, nitinol, and stainless steel. The configuration of the retaining member may be solid, braided, fibrous, etc., and should not be considered as being limited to any one particular embodiment.

[0360] According to one embodiment, the retaining member may be movable along the axis of the punching means. The retaining member may form an integral part of the elongated body of the punching means, or it may consist of 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, thereby contracting the lumen defined therein. For example, the retaining member comprises a plurality of portions made of a deformable material, with each pair of portions 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 present invention is a biological tissue removal tool (eliminating the need for suction) comprising at least one movable retaining member communicating with a punching means. At least one punching means has a lumen sized to receive a biological sample and a distal tip configured to penetrate the body surface. The retaining member moves relative to the punching means between a retracted position and a retaining position configured such that the retaining member protrudes into the punching means or transversely across the punching means at the proximal side of the distal tip, preventing the biological sample received in the lumen from moving toward the distal tip.

[0362] The retaining member may be positioned inside the punching mechanism from the outside and movable. In one embodiment, the retaining member is spring-biased (e.g., torsion spring biased) to the retaining position. In another embodiment, the retaining member slides axially on the punching mechanism between a retracted position and a retaining position, and has a portion that enters the punching mechanism through an opening in the wall of an elongated body in the retaining 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 mechanism. In some alternative embodiments, an actuator displaces the retaining member between the retracted position and the retaining position, and the actuator may be automated. The retaining member may be rotatable between the retracted position and the retaining position.

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

[0364] It should be noted that coring devices may consist of several microneedles (punches) or a single microneedle (punch). Furthermore, it should be noted that each of them may be operated individually, or that a subgroup of them may be operated simultaneously. As described 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) can rotate together or individually. According to one embodiment, all punches (or needles) are coupled to one common shaft driven by an electric DC motor. According to another embodiment, there are multiple shafts driven by several electric DC motors.

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

[0367] As disclosed below, the skin cores dissected from each punch / needle are drawn into a collection chamber and ultimately into a canister via tubing for disposal, for example, by vacuum or any retaining element(s) (e.g., incorporated within the punch). To ensure that the tubing is not clogged, a liquid (e.g., saline) may be added to the chamber via a dripping mechanism to flush the system out from at least one of the ends of the punch.

[0368] A visual subsystem, directed towards the area where the punch tip extends, detects the 3D position of the skin surface and uses a movable arm joint to align the punch(s) perpendicular to the skin plane. For sub-millimeter precision, the 3D visual subsystem employs either a passive (two cameras) or active (two cameras and an infrared laser projector) stereo vision approach.

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

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

[0371] According to one embodiment of the present invention, it is emphasized that, prior to treatment, the affected skin or its surroundings should be stretched using an stretching element (e.g., Tegaderm) to stabilize the skin before coring (to prevent compression before coring).

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

[0373] According to one embodiment, the system can use automated and artificial intelligence algorithms to repeatedly implement the described coring procedures in accordance with treatment plan rules. It should be noted that artificial intelligence is also used to determine the treatment plan and coring protocol (e.g., patterns of coring elements).

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

[0375] The system remembers where previous holes were created by tracking unique reference identifiers, preventing the possibility of overlapping holes. Furthermore, treatment automation addresses dynamic elements not incorporated into the treatment plan, such as restricted areas, surgical equipment malfunctions, and bleeding.

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

[0377] Before using the apparatus 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 adhesive biocompatible reference marker.

[0378] Images of the treatment area with surgical lines and reference markers are 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% to 30% and a skin tightening direction.

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

[0380] The punches (microneedles) are sharp, hollow, and have a diameter ranging from approximately + / - 0.4mm to 4.0mm. Larger holes may increase the treatment speed, but they are not suitable for all skin types and lesion types. A typical coring depth is approximately 1mm to 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 visual subsystem. The visual system registers the treatment zone in the treatment plan by searching for specific reference identifiers or colored lines on the skin. Coring equipment and skin removal subsystem

[0382] The device performs the skin microcoring process using multiple hollow, rotating, sharp punches. Each punch, shown in Figure 2, has a cylindrical shape with a sharp, conical cutting tip at the top. To ensure a complete incision, each punch has a sharp inner edge and an outer bevel. Note that any other cross-sectional area of ​​the punches would function similarly.

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

[0384] Referring now to Figures 3A to 3D, the distal end of an applicator with seven punches is shown, with six punches surrounding the seventh punch.

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

[0386] Referring now to Figure 3E, another embodiment of the distal end of an applicator having six punches (not seven punches as shown in Figures 3A-3D) is shown. As shown in Figure 3e, the six microcoring needles (punches) are arranged in two groups of three microcoring needles, with each group positioned at the vertices of a horizontally laid-down "V" pattern, i.e., a ">>" pattern. It should be noted that the arrangement of the six microcoring needles (punches) with at least two horizontally laid-down "V" shapes facing each other is within the scope of the present invention, i.e., a "><" pattern. However, those skilled in the art will understand that any pattern may be used. For example, the pattern of the microcoring needles (punches) may be selected from the group consisting of circular, hexagonal, rectangular, square, and any combination thereof.

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

[0388] The punch is connected to a skin core accumulation chamber. The skin core incised by each punch is drawn into the accumulation chamber, for example by vacuum (see arrow 401), and finally drawn into a canister (not shown) via a tube for disposal (see Figure 4). Note that instead of vacuum, the system may include at least one retaining element adapted to hold or contain the excised tissue (without applying vacuum). To ensure that the tube is not clogged, a liquid (e.g., saline) may be added to the chamber via a drip mechanism to flush out the system.

[0389] In another embodiment, a liquid (e.g., saline solution) is added to reduce friction during the coring step.

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

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

[0392] In another embodiment, all arms may include the same mechanism, or each arm may have a different mechanism, for example, a different incision / excision means (for example, one arm is used for incision and a second arm is used for seeding or insertion / injection of an additive (e.g., thread, hyaluronic acid, etc.), as disclosed below).

[0393] According to another embodiment of the present invention, each punch is operated individually, and in some embodiments, several punches are located on at least one arm of the device. However, since each is operated individually, the operator may operate only a few of the punches, rather than all of them.

[0394] According to another embodiment of the present invention, the distance between each punch can be adjusted. Referring here to Figure 5b, one arm 510 of an instrument is shown having six punches 520 spaced apart from each other by distances X (see reference no. 521) and Y (see reference no. 522). According to one embodiment, X and Y are adjustable so that the distance between the punches can be changed to better adjust the punches for treatment. Automation and artificial intelligence algorithms

[0395] According to one embodiment, the system uses automated and artificial intelligence algorithms to analyze mechanical visualization input and determine and establish the most appropriate coring pattern and plan. The artificial intelligence then instructs the system to repeatedly perform the described coring procedure in accordance with the treatment plan rules.

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

[0397] Automation arranges and packs hexagonal patterns to achieve a planned density. For example, in Figures 7-9, one instrument design may have widened punches to allow overlapping patterns, while another design may have punches that are packed tightly together. The system remembers where previous holes were made by tracking unique reference identifiers, preventing the possibility of holes overlapping. Furthermore, treatment automation addresses dynamic elements not incorporated into the treatment plan, such as restricted zones, surgical equipment malfunctions, and bleeding.

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

[0399] In another embodiment, the apparatus of the present invention also includes a mechanism configured to step a microcoring punch and position the microcoring punch such that one element selected from the group consisting of vertices, facets, and any combination thereof of the stepped microcoring punch hexagon traverses one element selected from the group consisting of vertices, facets, and any combination thereof of the first microcoring punch hexagon. In some embodiments, the stepping mechanism is implemented as a stepper that translates the position of the punch so that after a 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 vertices or facets) and another coring step, and according to another embodiment of the present invention, there may be an overlap between consecutive coring steps (as shown in Figure 7).

[0401] According to another embodiment of the present invention, the system uses artificial intelligence and / or mechanical visualization, OCT, ultrasound, machine learning algorithms and / or image processing to determine information regarding the coring location. That is, the system first scans the tissue to be treated using at least one selected from the group consisting of artificial intelligence, mechanical 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 of Direction

[0402] At the end of the treatment, the operator uses stretch / compression instruments to close the holes in the skin and promote healing of each new dimension 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 holes in the skin. Compressing the skin, according to its modification (compression) configuration, allows for wound healing, collagen accumulation, and adhesion of the cored wall. Thus, compression causes the cored hole to become elliptical rather than circular in shape, configured to be stabilized in its position by new collagen, promoting healing with an aesthetic skin tightening result (less likely to cause scarring) due to the compression core accumulated along each axis.

[0404] The stretch / compression devices disclosed herein generate compressive force on an internal surface and tension on an external surface to eliminate undesirable puncture scars.

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

[0406] Next, we refer to Figures 10A and 10B, which show one embodiment of the extension / compression device.

[0407] According to this embodiment of the present 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 the at least one slotted hole. The long portion is passed through the slot and secured to the short portion (details below). The securing of the long portion to the short portion is done by attaching at least one adhesive layer of the long portion to at least one adhesive layer of the short portion.

[0408] Next, we refer to Figures 11 and 12, which show the short side of the extension / compression device according to this embodiment. According to this embodiment, the short side has a base, adhesive, and liner.

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

[0410] The base can be made from any material that has sufficient strength to withstand a shear force of, for example, 10 PSI, and the adhesive adheres well to the skin.

[0411] The liner is a cover that protects the adhesive until it is used.

[0412] Next, refer to Figures 13 and 14, which show the longer side of the extension / compression device according to this embodiment.

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

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

[0415] The adhesive can be made from any material that has sufficient strength to withstand a shear force of, for example, 10 PSI, and adheres well to the skin.

[0416] The liner is a cover that protects the adhesive until it is used.

[0417] In one embodiment, the hook-and-loop member (e.g., sheet) is Velcro. In one example, the hook sheet is a male side having a small semi-rigid hook on its upper surface, and the loop sheet is a female side having a thin loop on its upper surface. When the upper surface of the hook and the upper surface of the loop come into contact, the hook catches on the loop.

[0418] The bottom surfaces of both sheets have adhesive to bond them to the base. This is not always necessary. Alternatively, if the sheets have sufficient strength, they can act as the base layer.

[0419] In one embodiment, the loop sheet covers most of the contact surface of the long piece. This allows the loop sheet to be thinner than the hook sheet, resulting in smoother tape movement. The reverse is also possible, where the hook sheet covers most of the long piece, but the hook sheet must be thin enough to have sufficient flexibility to fold over (see note in side view).

[0420] Once the stretch / compression device is placed over the skin opening, the operator extends the device to generate compression and / or tension to the desired level. Once the desired tension level is reached, the stretch / compression device can be closed and secured.

[0421] Applying stretching / compression devices can provide directional tightening of the skin.

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

[0423] Optimizing the applied tension of stretch / compression devices can offer numerous advantages. For example, such adjustability can allow for real-time control of compressing and / or expanding the stretch / compression device after it has been attached to the skin. This level of control can enable personalized treatment based on the disease, disorder, or symptom being treated, the optimal aesthetic effect to be achieved, the optimal closure process to be achieved, and / or the timing and extent of the healing process observed for a particular patient. Furthermore, adjustability can allow for less differentiated control over how incisions or excisions are created in the skin area, and more differentiated control over selectively closing or opening the incisions or excisions.

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

[0425] It should be noted that once incision or excision occurs, the wound healing process begins, which, as is generally known, includes collagen synthesis and maturation. Therefore, facilitating the formation and accumulation of collagen in each deformed coring area is within the core of the present invention.

[0426] An adjustable dressing may include an adhesive layer (formed, for example, from any adhesive material 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 the 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 the adhesive materials to make it adjustable. In certain embodiments, this arrangement allows for directional or non-directional compression and / or expansion as the dressing is compressed and / or expanded. In certain embodiments, the adhesive layer is a discontinuous layer and includes an arrangement of adhesive materials (e.g., an arrangement of dots where each dot moves closer to each other as the dressing is compressed and each dot moves further apart as the dressing expands). Exemplary adhesive materials described herein include collagen crosslinking-promoting materials such as riboflavin or rose bengal, synthetic adhesives (e.g., cyanoacrylate, polyethylene glycol, or gelatin-resorcinol-formaldehyde), or biological sealants (e.g., albumin-based or fibrin-based sealants that promote coagulation).

[0427] The stretching / compression device may further include at least one occluding layer (e.g., for controlling moisture and / or promoting wound healing), at least one absorbent layer (e.g., for absorbing wound exudate), at least one reinforcing layer (e.g., for reinforcing the layers and optionally formed from low-density polyethylene (LDPE), fluorinated ethylene propylene (FEP), or nylon), and / or at least one delivery layer (e.g., for delivering one or more therapeutic agents to improve its treatment).

[0428] The stretch / compression device may be an instrument of any aesthetically pleasing color, shape, and / or material. For example, the stretch / compression device may be provided in a skin tone, or it may be transparent or translucent. Such transparent or translucent dressings may also be useful for visibility, for example, for real-time adjustability of the dressing, and / or for attaching the stretch / compression device to the skin area being treated.

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

[0430] According to another embodiment of the present invention, the stretch / compression device is first stretched (after the excision of the skin portion) and only then applied to (i.e., fixed to) the skin. When the stretch / compression device is applied and stretched, the stretch / compression device (being elastic, therefore a dressing) is compressed back to its original shape, thereby applying compressive tension to the skin and providing directional tightening of the skin.

[0431] In other words, the stretch / compression device can first undergo pretreatment (stretching force is applied to the stretch / compression device (e.g., by a specialized device)), and once fully / partially stretched, it can be applied to the skin.

[0432] According to another embodiment of the present invention, the stretching / compression device that may be used is simply adhesive tape, for example, 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). Skin tightening methods, more specifically, directional skin tightening methods

[0433] The present invention relates to various methods and devices (e.g., stretching / compression devices) used for selectively opening or closing incisions and / or excisions (e.g., all or part of such incisions and / or excisions, such as microslits and / or holes) formed in a skin area by an incised or excised tissue portion. Stretching / compression devices may be attached to the entire skin area to be treated, or to a portion of the skin area to be treated, thereby enabling directional or non-directional tightening by generating a geometric or non-geometric arrangement of the incisions and / or excisions to be treated, similarly or differently. Furthermore, the device may result in uniform or non-uniform compression and / or squeezing across the entire device or a portion thereof. Thus, these methods and devices can achieve a reduction in skin surface area and / or skin tightening.

[0434] The method may include contraction or expansion in one or more directions in at least a portion of the instrument (e.g., a dressing). The method may include, for example, the step of applying the stretch / compression instrument to a skin area having a plurality of incised and / or excised tissue portions (for example, at least two of the tissue portions having at least one dimension of less than about 1 mm, or about 1 mm) 2 (Having an area dimension less than ). The device contracts or expands a skin area in one or more directions (e.g., x, y, z, xy, xz, yz, and / or xyz directions, as described herein), and such contraction or expansion may be uniform or non-uniform. Furthermore, contraction or expansion occurs by exposing the attached device to one or more external stimuli (e.g., any of those described herein) resulting from applying force (e.g., compressive or stretching force) to the stretch / compression device. Furthermore, such contraction and / or expansion may be adjusted after the device has been attached. For example, after treating the skin and attaching the device, the device may be further expanded or the skin area may be compressed. In this way, the device is adjustable / adjustable.

[0435] The present invention further includes a method for tightening skin in a preferred direction (e.g., directional tightening of skin by compression and / or expansion applied by an instrument).

[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 and oval holes. Non-circular holes can be formed by using an instrument having a non-circular cross-section (e.g., a tube such as a blade or hollow tube having a non-circular cross-section) or by pre-stretching the skin before treatment with an instrument having a circular cross-section (e.g., a circular coring needle will create an oval hole in unstretched skin).

[0437] In some embodiments, the major axis of the ellipse is perpendicular to the pre-stretch direction, and the elliptical hole can preferentially produce skin tightening in the direction of the minor axis of the ellipse. Thus, the stretch / compression device can be attached to a skin portion containing one or more holes, or to one or more incised or excised tissue portions having one or more geometric shapes.

[0438] It should be noted that once incision or excision occurs, the wound healing process begins, which, as is generally known, includes collagen synthesis and maturation. Therefore, facilitating the formation and accumulation of collagen in each deformed coring area is within the core of the present invention. Adhesives that can be incorporated into extension / compression devices

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

[0440] Adhesives can be pressure-sensitive adhesives (PSAs). The properties of pressure-sensitive adhesives are influenced by three parameters: tackiness (initial adhesion), peel strength (adhesion), and shear strength (cohesion). Pressure-sensitive adhesives can be synthesized in several ways, including solvent-based, aqueous, and hot-melt methods. Tackiness is the initial adhesion under low pressure and short residence time conditions 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 strength depends on many factors, including tackiness, bonding history (e.g., force, residence time), and the adhesive composition. Shear strength is a measure of the adhesive's resistance to continuous stress. Shear strength is influenced by several parameters, including the adhesive's internal adhesion, crosslinking, and viscoelastic properties. Permanent adhesives are generally resistant to peeling and have very high peel and shear strengths.

[0441] Examples of adhesives include biocompatible matrices (e.g., those comprising 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)-thion (N-HTP), porphyrin, or chlorin, and their precursors); 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., mixtures of riboflavin-5-phosphate and fibrinogen, fibrin-based sealants, albumin-based sealants, or starch-based sealants). In certain embodiments, the adhesive is biodegradable.

[0442] Examples of pressure-sensitive adhesives include natural rubber, synthetic rubber (e.g., styrene-butadiene copolymer and styrene-ethylene copolymer), polyvinyl ether, polyurethane, acrylic, silicone, and ethylene vinyl acetate copolymer. The adhesive properties of copolymers can be altered by changing the composition (via monomer components) and thus changing the glass transition temperature (Tg) or degree of crosslinking. Generally, copolymers with lower Tg have lower stiffness, while copolymers with higher Tg have higher stiffness. The tackiness of PSAs can be altered by adding components that change viscosity or mechanical properties. Examples of pressure-sensitive adhesives are described in Chapter 17 (2011) of "Pressure-Sensitive Adhesives for Medical Applications," Wide Spectra of Quality Control, edited by Dr. Isin Akyar, published by InTech, Czech et al., and the entire content of this work is incorporated herein by reference.

[0443] In one exemplary technique, a photosensitizer (e.g., rose bengal (RB) at a concentration of less than 1.0% by weight / volume in a buffer (e.g., phosphate-buffered saline) for forming a skin tissue-RB complex) is added to the tissue, and the tissue is then irradiated with electromagnetic energy to generate a seal (e.g., 2000 J / cm² at a wavelength of at least 488). 2 Less than and / or 1.5 W / cm² 2 Less than, for example, about 0.6 W / cm² 2 (Irradiated with light). This exemplary technique is described in U.S. Patent No. 7073510, the entirety of which is 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 irradiated with visible light to produce a seal.

[0444] According to one embodiment of the present invention, a therapeutic agent may be incorporated into a stretching / compression device to be released into a pore in the skin 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 hyperpigmentation (e.g., hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide); one or more analgesics (e.g., paracetamol / acetaminophen, aspirin, napsylate dextrin, as described herein). Lopropoxyfen, cocodamole, opioids (e.g., morphine, codeine, oxycodone, hydrocodone, dihydromorphine, pethidine, buprenorphine, tramadol, or methadone), fentanyl, procaine, lidocaine, tetracaine, dibucaine, benzocaine, 2-(diethylamino)ethyl p-butylaminobenzoate HCl, mepivacaine, pipelocaine, diclonin, or venlafaxine); one or more antibiotics (e.g., cephalosporins, bacitracin, polymyxin B sulfate, neomycin, bismuth tribromyl carbonate, or polysporin);One or more antifungal agents (e.g., nystatin), one or more anti-inflammatory agents (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, ketoprofen, flurbiprofen, piroxicam, indomethacin, diclofenac, sulindac, naproxen, aspirin, ketorolac, or tacrolimus), cyclooxygenase-2-specific inhibitors (COX-2 inhibitors, e.g., rofecoxib (Vioxx®), etoricoxib, 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 mineralocorticoid drugs (e.g., aldosterone, corticosterone, or deoxycorticosterone)), or immune-selective anti-inflammatory derivatives (e.g., phenylalanine-glutamine-glycine (FEG) and its D-isomer (feG)))); one or more antibacterial agents (e.g., chlorhexidine gluconate, iodine (e.g., iodine tincture, 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 one or more useful carriers (e.g., Acticoat® containing a nanocrystalline silver coating in high density polyethylene commercially available from Smith & Nephew (London, UK) or Silvercel® containing a mixture of alginate, carboxymethylcellulose, and silver-coated nylon fibers commercially available from Systagenix (Gatwick, UK)), Ag in an alginate); +; Foam (e.g., Contree® Foam containing flexible hydrophilic polyurethane foam and silver, commercially available from Coloplast A / S (Humrebeck, Denmark); hydrophilic colloid (e.g., Aquacel® Ag containing ionic silver and hydrophilic colloid, commercially available from Conva Tec (Skillman, New Jersey); or hydrogel (e.g., Medline); Silvasorb®, a registered trademark containing ionic silver, commercially available from Industries, Inc. (Mansfield, Massachusetts); one or more disinfectants (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; phenol (carbolic acid) compounds (e.g., sodium 3,5-dibromo-4-hydroxybenzenesulfonate, trichlorophenylmethyliodosalicylic acid, or triclosan); polyhexanide compounds (e.g., polyhexamethylene biguan). PHMB); quaternary ammonium compounds (e.g., benzalkonium chloride (BAC), benzethonium chloride (BZT), cetylmethylammonium 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 triallyl methane dyes (e.g., Brilliant Green); one or more antiproliferative agents (e.g., sirolimus, tacrolimus, zotarolimus, biolimus, or paclitaxel); one or more emollients;One or more hemostatic agents (e.g., collagen such as microfibrous collagen, chitosan, calcium-containing zeolite, cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum, titanium dioxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetylglucosamine, thrombin, coagulation factors (multiple possible) (e.g., factors II, V, VII, VIII, IX, X, XI, XIII, or von Willebrand factors, and their active forms), procoagulants (e.g., (Propyl gallate), antifibrinolytic agents (epsilon-aminocaproic acid or tranexamic acid, etc.); one or more procoagulants (e.g., any hemostatic agents described herein, desmopressin, coagulation factors (plural) (e.g., factors II, V, VII, VIII, IX, X, XI, XIII, or von Willebrand factors, and their active forms), coagulants (e.g., propyl gallate), antifibrinolytic agents (e.g., epsilon-aminocaproic acid, etc.); one or more anticoagulants Blood agents (e.g., heparin or its derivatives such as low molecular weight heparin, fondaparinux, or hydraparinax; antiplatelet agents such as aspirin, dipyridamole, ticlopidine, clopidogrel, or prasugrel; factor Xa inhibitors such as direct-acting factor Xa inhibitors (e.g., apixaban or rivaroxaban); thrombin inhibitors such as direct-acting thrombin inhibitors (e.g., argatroban, bivalirudine, dabigatran, hirudin, repirudine, or ximelagatran; or coumarin derivatives or vitamin K antagonists (e.g., warfarin (coumadin), asenocoumarol, atromentine, phenindione, or fenprocumon); one or more immunomodulators including corticosteroids and nonsteroidal immunomodulators (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, the skin tightening effect can be more effectively controlled by controlling the degree of bleeding and / or coagulation at the incision and / or excision site. Accordingly, in some embodiments, the methods and devices herein include one or more anticoagulants, one or more procoagulants, one or more hemostatic agents, or a combination thereof. In certain embodiments, the therapeutic agent controls the degree of bleeding and / or coagulation in the skin area being treated, including the use of one or more anticoagulants (e.g., to inhibit clot formation before skin healing or slit / hole closure) and / or one or more hemostatic or procoagulants. Methods for treating skin conditions

[0446] The present invention relates to methods and apparatus that can be applied to areas of skin 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 apparatus and methods of this specification can be used for skin rejuvenation (e.g., pigment removal, tattoo removal, vein (e.g., spider veins or reticular veins), and / or vascular tissue of the skin), or for acne, allodynia, blemishes, ectopic dermatitis, hyperpigmentation, hyperplasia (e.g., lentigo or keratosis), loss of transparency, loss of elasticity, melanosis (e.g., epidermal, dermal, or mixed subtype), photodamage, rash (e.g., erythematous, macular, papules, and / or vesicular symptoms), psoriasis, fine wrinkles (or wrinkles, e.g., crow's feet, age-related fine wrinkles, sun-induced wrinkles) It may be useful for related wrinkles (or wrinkles related to genetics), poor complexion, scar contracture (e.g., laxity of scar tissue), scarring (e.g., due to acne, surgery, or other trauma), skin aging, skin contracture (e.g., excessive tension of the skin), skin irritation / hypersensitivity, skin laxity (e.g., looseness or sagging of the skin, or other skin abnormalities), striae (or stretch marks), vascular lesions (e.g., angioma, erythema, hemangioma, papules, port-wine stains, rosacea, reticular veining, or telangiectasia), or any other undesirable skin abnormalities.

[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., breast lift), arms, legs, nose, forehead, buttocks, and / or back. Accordingly, the instruments of the present invention may be positioned or configured to adapt to the size or shape of different body regions. Such positioning and configuration may include any useful shape (e.g., linear, curved, or star-shaped), size, and / or depth.

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

[0449] Furthermore, fractional treatment resulting in multiple tissue portions can 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 such patterns can be achieved by arranging hollow tubes, for example, within their bases (see Figures 7-9). It should be emphasized that according to one embodiment of the present invention, there may be overlap (by vertices or facets) between one coring step and another coring step, and according to another embodiment of the present invention, there may be overlap in the cross-sections between consecutive coring steps (as shown in Figure 7). That is, the first cross-sectional area of ​​the first coring step is hexagonal, as shown in Figure 7, for example. According to one embodiment of the present invention, the next step can perform coring at any position within the hexagonal cross-section of the first step.

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

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

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

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

[0454] Next, refer to Figure 17, which shows the histological analysis of tissue sections 0, 2, and 5 weeks after fractional coring (tissue removal) treatment.

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

[0456] After two and five weeks, healing occurred, including fibroblast migration, collagen synthesis, and maturation, resulting in skin tightening.

[0457] According to another embodiment of the present invention, the excised tissue may be subjected to any embodiment as disclosed above, but its directional tightening may be further carried out by the use of at least one energy source selected from the group consisting of the application of temperature for heating and discharging the tissue, the application of a laser, RF, coagulation, microwave energy, ultrasound, the application of any other type of energy, and any combination thereof.

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

[0459] Here, we refer to Figures 15 and 16, which schematically illustrate such embodiments.

[0460] Figure 15a schematically shows a skin region in which multiple excised areas 150 have been formed. This figure also incorporates an RF electrode 150, which is adapted to apply energy to the skin after excision to perform directional tightening. It is within the scope of the present invention that when RF energy is applied to the tissue, different magnetic fields are generated between the excised tissues to tighten the skin (see arrow 152).

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

[0462] In another embodiment, two RF electrodes are used where applicable (each from a different side of the skin) (see Figure 15d).

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

[0464] Figures 15 and 16 show RF electrodes and RF energy, but it should be emphasized that the same applies to laser application, RF, pulsed electromagnetic fields, coblation, coagulation, microwave energy, ultrasound, application of other types of energy, and combinations thereof. A combination of energy-based coring and mechanical-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] In such embodiments, the punch / needle is adapted to penetrate the skin and coring the skin (to create multiple excised tissue portions) and to deliver RF energy simultaneously or sequentially to heat the tissue and cause tissue fragmentation ablation / coagulation. In such embodiments, the punch / needle is essentially an RF electrode and a cutting element.

[0467] The application of RF energy to the skin to facilitate tissue excision and to apply shocks to the tissue through ablation and coagulation, which are derived from wound healing, falls within the scope of the present invention.

[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 wave frequency generator is in communication with at least one of the punches / needles. According to another embodiment, the pulsed electromagnetic wave frequency generator is adapted to generate a dynamic magnetic field so that electromagnetic pulses are delivered to the area of ​​the patient's skin. According to another embodiment, the electromagnetic pulses change over time.

[0471] According to another embodiment, the dynamic magnetic field is generated by at least one coil. According to another embodiment, at least one punch / needle 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 present invention, all of the punches / needles are adapted to simultaneously deliver the electromagnetic pulses to the area of ​​the patient's skin and apply RF energy. According to one embodiment of the present invention, the RF energy is applied to the area of ​​the patient's skin in the form of heat.

[0473] According to another embodiment of the present invention, the control unit monitors and / or controls the application of the heat (by RF energy) to the tissue within the area 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 triangular 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 pulse electromagnetic wave frequency generator is in the range of 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 pulse electromagnetic wave frequency generator is in the range of about 0 gauss to about 40 gauss.

[0477] According to another embodiment of the present invention, the duration of each pulse applied by the pulse electromagnetic wave frequency generator is in the range of about 3 milliseconds to about 1000 milliseconds.

[0478] According to another embodiment of the present invention, the frequency F applied by the pulse of the pulse electromagnetic wave frequency generator is in the range of 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 pulse electromagnetic wave frequency generator is in the range of 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 the step of applying pulsed electromagnetic therapy to the region is higher than about 1 Hz and lower than about 1 MHz.

[0481] According to another embodiment of the present 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 present invention, the power P applied by the RF energy pulse is an RMS average power of 1W to 100W.

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

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

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

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

[0488] In such embodiments, the punch / needle is fitted to penetrate the skin and coring the skin (to create multiple excised tissue portions), and the RF electrode is fitted to deliver RF energy simultaneously or sequentially to heat the tissue and cause tissue fragmentation ablation / coagulation.

[0489] The application of RF energy to the skin not only facilitates tissue excision, but also applies ablation and coagulation treatments to the tissue, which falls within the scope of this invention.

[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, the pulsed electromagnetic wave frequency generator is in communication with at least one RF electrode. According to another embodiment, the pulsed electromagnetic wave frequency generator is adapted to generate a dynamic magnetic field so that an electromagnetic pulse is delivered to the area of ​​the patient's skin. According to another embodiment, the electromagnetic pulse changes over 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 wound by at least one coil. According to another embodiment, all of the RF electrodes are at least partially wound by one coil.

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

[0494] According to another embodiment of the present invention, the control unit monitors and / or controls the application of heat (by RF energy) to the tissue within the area of ​​the 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 triangular 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 pulse electromagnetic wave frequency generator is in the range of 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 pulse electromagnetic wave frequency generator is in the range of about 0 gauss to about 40 gauss.

[0498] According to another embodiment of the present invention, the duration of each pulse applied by the pulse electromagnetic wave frequency generator is in the range of about 3 milliseconds to about 1000 milliseconds.

[0499] According to another embodiment of the present invention, the frequency F applied by the pulse of the pulse electromagnetic wave frequency generator is in the range of 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 pulse electromagnetic wave frequency generator is in the range of 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 the step of applying pulsed electromagnetic therapy to the region is higher than about 1 Hz and lower than about 1 MHz.

[0502] According to another embodiment of the present 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 present invention, the power P applied by the RF energy pulse is an RMS average power of 1W to 100W.

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

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

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

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

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

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

[0511] As described above, according to one object of the present invention, the system comprises at least one vacuum subsystem adapted to perform suction to remove the excised portion of the skin tissue. By combining at least one cutting element within the system, the extraction of the excised tissue by the vacuum subsystem is facilitated. Alternatively, the cutting element facilitates coring / removal of the excised tissue with the help of a retaining member. Injectable substances

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

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

[0514] According to another embodiment of the present invention, the needle may have either a uniform or non-uniform 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 the adhesives described above.

[0516] Therefore, a directional skin tightening method for the skin region, (ii) A step of preparing multiple excised tissue portions in a region of skin tissue, (ii) A step of applying energy to the skin region to contract or expand the skin region in a predetermined direction to perform directional skin tightening in the skin tissue. Providing a method that includes [the above] is within the scope of the present invention.

[0517] Another object of the present invention is to provide the method defined above, further comprising the step of applying stretch tension to the skin region prior to the step of producing a plurality of excised tissue portions.

[0518] Another object of the present invention is to provide the method defined above, 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.

[0519] Another object of the present invention is to provide the method defined above, wherein the step of producing a plurality of excised tissue portions in a region of skin tissue is carried out by means selected from the group consisting of mechanical means, the application of temperature for heating and discharging the tissue, the application of a laser, RF, pulsed electromagnetic field, coagulation, coagulation, microwave energy, ultrasound, the application of any other type of energy, and any combination thereof.

[0520] Another object of the present invention is to provide the method defined above, wherein the step of applying energy to the skin region to contract or expand the skin region is carried out by means selected from the group consisting of mechanical means, temperature application for heating and discharging tissue, laser application, RF, pulsed electromagnetic field, coagulation, 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 the method defined above, wherein the step of producing a plurality of excised tissue portions in a region of skin tissue is performed by a system comprising at least one robotic arm, the at least one robotic arm comprising at least one skin coring device.

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

[0523] Another object of the present invention is to provide the apparatus or method defined above, wherein the plurality of punches is at least seven punches, six of which are arranged in a hexagonal shape centered on a seventh central punch.

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

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

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

[0527] Another object of the present invention is to provide the method defined above, wherein the plurality of punches feature similar or substantially different cross-sectional areas.

[0528] Another object of the present invention is to provide the method defined above, wherein the plurality of punches are adapted to penetrate the skin to a depth of 1 mm to 4 mm.

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

[0530] Another object of the present invention is to provide the method defined above, wherein the cross-sectional area is 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.

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

[0532] Another object of the present invention is to provide the method defined above, wherein the controller comprises 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 the number of cores, different areas of the skin to be treated, and any combination thereof.

[0533] Another object of the present invention is to provide the above-defined method in which the parameters are adjusted manually by an operator or automatically by a controller.

[0534] Another object of the present invention is to provide the above-defined method by which the parameters are adjusted in real time.

[0535] Another object of the present invention is to provide the method defined above, wherein the rotational speed is in the range of 1000 RPM to 7000 RPM.

[0536] Another object of the present invention is to provide the above-defined method wherein the translational speed is in the range of 0 mm / sec to 500 mm / sec.

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

[0538] Another object of the present invention is to provide the above-defined method wherein the rotation of the at least one robotic arm changes as the at least one robotic arm approaches and penetrates the skin.

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

[0540] Another object of the present invention is to provide the above-defined method by which the plurality of punches rotate simultaneously.

[0541] Another object of the present invention is to provide the above-defined method wherein each of the plurality of punches translates individually.

[0542] Another object of the present invention is to provide the above-defined method in which the plurality of punches are translated simultaneously.

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

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

[0545] Another object of the present invention is to provide the method defined above, wherein the controller is adapted to define at least one non-fly zone, the non-fly zone being defined as an area not treated by the system.

[0546] Another object of the present invention is to provide the above-defined method by which the system further imparts additives to the skin.

[0547] Another object of the present invention is to provide the method defined above, wherein the additive is selected from the group consisting of therapeutic agents, 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; steroids, agents for preventing post-inflammatory hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungal agents; one or more anti-inflammatory agents, or mineralocorticoids, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; foams; or hydrogels, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, coagulants, 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.

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

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

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

[0551] Another object of the present invention is to provide the method defined above, wherein the skin may be part of a treatment area selected from the group consisting of the forehead, cheeks, jaw contour, neck, thigh, upper arm, abdomen, stomach, 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 the methods defined above for use for local 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, blemishes, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigo or keratosis, loss of transparency, loss of elasticity, melanosis, photodamage, psoriasis, fine lines, wrinkles, poor complexion, scar contracture, scarring, wrinkles, folds, acne scars, pigment disorders, striae, surgical scars, cellulite, tattoo removal, cheek wrinkles, facial wrinkles, facial folds, skin aging, skin contracture, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangioma, papules, port-wine stains, rosacea, reticular vein, or telangiectasia, or any other undesirable skin abnormalities and any combination thereof.

[0553] Another object of the present invention is to provide the method defined above, in which 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 tissue to be treated and enhance the outcome of the treatment.

[0554] Another object of the present invention is to provide the method defined above, wherein the area ratio of the excised tissue portion is approximately 5% to approximately 30% of the skin area.

[0555] Another object of the present invention is to provide the method defined above, wherein the area ratio of the excised tissue portion is less than approximately 10% of the skin area.

[0556] Another object of the present invention is to provide the method defined above, which includes the step of pre-stretching a skin area before the step of producing a plurality of excised tissues.

[0557] Another object of the present invention is a directional skin tightening system for the skin region, (i) Means for producing multiple excised tissue portions in a region of skin tissue, (ii) means for applying at least one type of energy to the skin region to contract or expand the skin region in a predetermined direction to perform directional skin tightening in the skin tissue; The objective is to provide a system that includes these features.

[0558] Another object of the present invention is to provide the system defined above, further comprising means for applying stretch tension to the skin region prior to the step of producing a plurality of excised tissue portions.

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

[0560] Another object of the present invention is to provide the system defined above, wherein the means for producing a plurality of excised tissue portions in a region of skin tissue comprises means selected from the group consisting of mechanical means, temperature application for heating and discharging tissue, laser application, RF, coagulation, microwave energy, pulsed electromagnetic field, ultrasound, and application of any other type of energy, and any combination thereof.

[0561] Another object of the present invention is to provide the system defined above, wherein the means for applying energy to the skin region to contract or expand the skin region comprises means selected from the group consisting of mechanical means, temperature application for heating and discharging tissue, laser application, RF, pulsed electromagnetic field, coagulation, 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 the above-defined system wherein the means for producing a plurality of excised tissue portions in a region of skin tissue comprises a system comprising at least one robotic arm, and the at least one robotic arm comprises at least one skin coring device.

[0563] Another object of the present invention is to provide the system defined above, wherein the at least one skin corering device (e.g., a skin corer) comprises a plurality of punches configured to contact the surface of the skin in order to create holes in the skin tissue by excised portions of skin tissue.

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

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

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

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

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

[0569] Another object of the present invention is to provide the system defined above, wherein the plurality of punches are adapted to penetrate the skin to a depth of 1 mm to 4 mm.

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

[0571] Another object of the present invention is to provide the system defined above, wherein the cross-sectional area is 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.

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

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

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

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

[0576] Another object of the present invention is to provide the above-defined system, wherein the rotational speed is in the range of 1000 RPM to 7000 RPM.

[0577] Another object of the present invention is to provide the above-defined system, wherein the translational speed is in the range of 0 mm / sec to 500 mm / sec.

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

[0579] Another object of the present invention is to provide the above-defined system wherein the rotation of the at least one robotic arm changes as the at least one robotic arm approaches and penetrates the skin.

[0580] Another object of the present invention is to provide the system defined above, in which each of the plurality of punches rotates individually in a predetermined direction at a predetermined speed. In some embodiments, a rotor is configured to rotate the punches at the same speed.

[0581] Another object of the present invention is to provide the system defined above in which the plurality of punches rotate simultaneously.

[0582] Another object of the present invention is to provide the above-defined system in which each of the plurality of punches translates individually.

[0583] Another object of the present invention is to provide the system defined above in which the plurality of punches are translated simultaneously.

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

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

[0586] Another object of the present invention is to provide the system defined above, wherein the controller is adapted to define at least one non-fly zone, the non-fly zone being defined as an area not treated by the system.

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

[0588] Another object of the present invention is to provide the above-defined system for further imparting additives to the skin.

[0589] Another object of the present invention is to provide a system as defined above, wherein the additive is selected from the group consisting of therapeutic agents, 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; steroids, agents for preventing post-inflammatory hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungal agents; one or more anti-inflammatory agents, or mineralocorticoids, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; foams; or hydrogels, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, coagulants, 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 the system defined above, further comprising at least one imaging subsystem adapted to guide the at least one skin coring device.

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

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

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

[0594] Another object of the present invention is to provide the above-defined system for use for local 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, blemishes, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigo or keratosis, loss of translucency, loss of elasticity, melanosis, photodamage, psoriasis, fine lines, wrinkles, poor complexion, scar contracture, scarring, wrinkles, folds, acne scars, pigment disorders, striae, surgical scars, cellulite, tattoo removal, cheek wrinkles, facial wrinkles, facial folds, skin aging, skin contracture, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangioma, papules, port-wine stains, rosacea, reticular vein, or telangiectasia, or any other undesirable skin abnormalities and any combination thereof.

[0595] Another object of the present invention is to provide the above-defined system that 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 tissue to be treated and thereby enhance the outcome of the treatment.

[0596] Another object of the present invention is to provide the system defined above, wherein the area ratio of the excised tissue portion is approximately 5% to approximately 30% of the skin area.

[0597] Another object of the present invention is to provide the system defined above, wherein the area ratio of the excised tissue portion is less than approximately 10% of the skin area.

[0598] Another object of the present invention is to provide the system defined above, which includes pre-stretching a skin region before producing multiple excised tissues.

[0599] According to another embodiment of the present invention, the skin coring device (i.e., punch / needle) comprises at least one cutting element (e.g., at least one blade) adapted to crush / grind the tissue in order to facilitate the extraction of the cored / excised tissue. As described above, according to one object of the present invention, the system comprises at least one vacuum subsystem adapted to perform suction to remove the excised portion of the skin tissue. Combining at least one cutting element (cutter) within the system would facilitate the extraction of the excised tissue by the vacuum subsystem. Alternatively, the cutting element facilitates the removal of the cored / excised tissue with the help of a retaining member.

[0600] According to another embodiment of the present invention, when tissue coring is performed, heat is applied to the treatment area of ​​the skin. The heat can be generated by RF energy, lasers, 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 is adapted to apply energy to the treatment tissue after and / or during the coring stage.

[0602] Without departing from the scope and spirit of the present invention, various modifications and variations of the methods and systems described in the present invention will be apparent to those skilled in the art. Although the present invention has been described in relation to certain preferred embodiments, it should be understood that the claimed invention should not be unduly limited to such specific embodiments. In fact, various modifications of the described embodiments for carrying out the present invention will be apparent to those skilled in the art in medicine, pharmacology or related fields and will be included within the scope of the present invention.

Claims

1. A system for directional skin tightening in a skin region, wherein the system is (i) An excision device configured to produce a plurality of excised tissue portions within a region of skin tissue, wherein the excision device comprises at least one skin coring device, the at least one skin coring device comprises a plurality of punches, each of the plurality of punches is configured to rotate, and each of the plurality of punches is coupled to a common shaft actuated by an electric motor, (ii) An applicator configured to provide directional skin tightening within the skin tissue by applying at least one type of energy to the skin region in at least one predetermined direction, thereby providing contraction or expansion of the skin region in a predetermined direction, wherein the at least one type of energy comprises mechanical energy, A system equipped with these features.

2. The system according to claim 1, further comprising a tensioner configured to apply stretch tension to the skin region before the excision device produces a plurality of excised tissue portions.

3. The system according to claim 1, wherein the system is configured to provide directional skin tightening in at least one of the x, y, and z directions.

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

5. The system according to claim 1, wherein the at least one type of energy further comprises at least one of the following: application of temperature to heat and expel tissue, application of laser, RF, pulsed electromagnetic field, coagulation, coagulation, microwave energy, and ultrasound.

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

7. The system according to claim 1, wherein the excision device is configured to include at least one robotic arm, and the at least one robotic arm comprises at least one skin coring device.

8. The system according to claim 1, wherein the at least one skin coring device is configured to contact the surface of the skin in order to create a hole in the skin tissue by excising a portion of the skin tissue.

9. The system according to claim 8, wherein at least some of the plurality of punches are disposable.

10. The system according to claim 8, wherein the plurality of punches are adapted to penetrate the skin area either simultaneously or sequentially.

11. The system according to claim 10, wherein at least one of the following is true: (a) the plurality of punches are configured to have either similar or substantially different cross-sectional areas, the cross-sectional areas being selected from the group consisting of circular, rectangular, triangular, hexagonal, elliptical, staggered, parallel, spiral, square or rectangular patterns, radial distribution, and any combination thereof; (b) the plurality of punches are adapted to penetrate to a depth of 1 to 4 mm in the skin area; 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 according to claim 7, further comprising at least one controller adapted to control the position of the at least one robotic arm relative to the skin region, the controller 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 region, penetration depth, coverage, diameter of at least one excised tissue multiplied by the number of cores, different areas of skin to be treated, and any combination thereof, the parameter being adjusted manually by an operator or automatically by the controller.

13. The system according to claim 12, wherein at least one of the following is true: (a) the rotation is at a speed in the range of 1,000 to 7,000 RPM, the translation is at a speed in the range of 0 to 500 mm / second, (c) the translation of the at least one robotic arm relative to the skin region changes as the at least one robotic arm approaches the skin region, and (d) the rotation of the at least one robotic arm changes as the at least one robotic arm approaches and penetrates the skin region, and any combination thereof.

14. The system according to claim 10, wherein (a) each 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 according to claim 10, wherein (a) each of the plurality of punches is translated individually, or (b) the plurality of punches are translated simultaneously.

16. The system according to claim 12, wherein the controller comprises a stopping mechanism adapted to limit the depth to which at least some of the plurality of punches penetrate the skin area.

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

18. The system according to claim 12, wherein the controller is adapted to define at least one non-fly zone, the non-fly zone being defined as an area to which the system does not provide any treatment.

19. The system according to claim 1, wherein the system further provides an additive to the skin, the additive being selected from the group consisting of therapeutic agents, 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; steroids, agents for preventing post-inflammatory hyperpigmentation, hydroquinone, azelaic acid, kojic acid, mandelic acid, or niacinamide; one or more analgesics; one or more antifungal agents; one or more anti-inflammatory agents, or mineralocorticoids, immunoselective anti-inflammatory derivatives; one or more antibacterial agents; foam; or hydrogel, one or more disinfectants, one or more antiproliferative agents, one or more emollients; one or more hemostatic agents, coagulants, 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 according to claim 7, further comprising at least one imaging subsystem adapted to guide the at least one skin coring device, wherein the 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.

21. The system according to claim 1, further comprising a vacuum subsystem adapted to apply suction force to remove the excised portion of the skin tissue.

22. The system according to claim 1, wherein the skin area is located within a portion of a treatment area comprising at least one of the following: forehead, cheek, jaw contour, neck, upper arm, abdomen, face, eyelid, nose, forehead, chin, forehead, lips, nose, neck, thigh, chest, leg, and back.

23. The system according to claim 1, comprising: local 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, blemishes, ectopic dermatitis, hyperpigmentation, hyperplasia, lentigo or keratosis, loss of transparency, loss of elasticity, melanosis, photodamage, psoriasis, fine lines, wrinkles, poor complexion, scar contracture, scarring, wrinkles, folds, acne scars, pigment disorders, striae, surgical scars, cellulite, tattoo removal, cheek wrinkles, facial wrinkles, facial folds, skin aging, skin contracture, skin inflammation / hypersensitivity, skin laxity, striae, vascular lesions, angioma, erythema, hemangioma, papules, port-wine stains, rosacea, reticular vein, or telangiectasia, or any other undesirable skin abnormalities, and any combination thereof.

24. The system according to claim 1, wherein the skin region is stretched in advance before the preparation of the plurality of excised tissues.

25. The system according to claim 1, further comprising at least one cutter integrated within the skin coring device and adapted to crush the excised tissue to facilitate its removal.

26. The system according to claim 1, wherein each of the plurality of punches comprises a movable retaining element configured to hold the portion of skin tissue to be excised.

27. ​​The system according to claim 26, wherein the movable retaining element comprises a plurality of retractable claws.

28. A segmented coring device for directional skin tightening, wherein the device is (i) An excision device configured to produce a plurality of excised tissue portions within a region of skin tissue, wherein the excision device comprises at least one skin coring device, the at least one skin coring device comprises a plurality of punches, each of the plurality of punches is configured to rotate, and each of the plurality of punches is coupled to a common shaft actuated by an electric motor, (ii) A fastener having at least two parts, wherein the fastener is configured to fix at least one part of an extension / compression device to a region of the skin tissue, and the extension / compression device is adapted to provide contraction or expansion of the region of the skin tissue in at least one predetermined direction, thereby supporting collagen proliferation and providing directional skin tightening within the region of the skin tissue, A device equipped with the following features.

29. The apparatus according to claim 28, wherein the plurality of punches are mounted on a computer-controlled robot arm that can move within six or more axes to provide at least six degrees of freedom.

30. The apparatus according to claim 28, further comprising a video camera configured to provide visual feedback of at least the plurality of punches and skin, and a closed-loop force sensor for determining when the plurality of punches break the skin.

31. The apparatus according to claim 28, further comprising a cooler adapted to regulate skin temperature.

32. The apparatus according to claim 28, wherein the 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, and at least one of the at least one impedance sensor and at least one temperature sensor is adapted to provide an index of the depth of penetration of each of the at least one skin coring device.

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