DE102020129157A1 - Device for removing at least one object or an agglomeration of objects from the skin - Google Patents

Abstract

A device for removing at least one object (5) or an agglomeration of objects (5) from the skin is described, having a plurality of removal elements (2), in particular hollow needles and/or punches, which are arranged to be movable along a longitudinal direction of the removal elements (2). . The removal elements (2) are set up to penetrate an area of skin (4) when force is applied and to pick up the object (5) inside (6) in a target area, to separate it at least in areas from the surrounding area of skin (4) and to move this piece of skin in the direction of the skin surface (3) to move. The technical solution described is characterized in that a stamping element (7) is provided with a contact surface (8) which causes a movement of the skin surface when there is contact between the skin surface (3) and the contact surface (8). (3) at least limited and that the plurality of removal elements (2) can be moved relative to the plunger element (7), an actuating element (10) producing an operative connection between a drive (9) and the plurality of removal elements (2) being provided, by that the plurality of removal elements (2) in a first position, in which at least one of the removal elements (2) in the target area picks up the object (5) and then into a second position in which a lower end (11) of the object (5) facing the target area is in a plane with an uppermost skin layer adjoining the skin surface (3) within a cavity produced by at least one of the plurality of removal elements (2). (13) is transferred and that an ejection element (12) is provided, which is set up to eject the object (5) from the interior (6) due to a relative movement between the at least one removal element (2) and the ejection element (12). of the removal element (2), the object (5) at least almost maintaining its position within the cavity (13).

Description

The invention relates to a device for removing at least one object or an agglomeration of objects, such as particles, pieces of skin or pathologies, from the skin. For this purpose, means for generating microtraumas in at least one skin layer are provided, which have at least one activator that is designed to crush or destroy the at least one object in a target area of the skin layer or to separate it at least in areas from the surrounding skin area and/or a to cause increase in tissue pressure and increase in distance between collagen fibers.

Various technical solutions are known from the prior art for either removing objects and foreign bodies from the skin or for removing specific pieces of skin, for example in order to transplant them to a different location. Cutting tools, in particular punches or special scalpel elements, which are introduced into the skin for removal, are usually used here. The at least one object to be removed is then removed from the skin with the cutting tool itself or with an additional medical instrument, with at least partially significant injuries, scars and/or skin irritations occurring.

In this context it is from the WO 2016/033584 A1 a skin punch with a plurality of punches arranged in an array is known. Using the punch described, arrays of pieces of skin can be removed from healthy skin areas and transplanted to other sites. The device has a plurality of punches which are arranged within a housing and are inserted into the skin to remove the pieces of skin. Through targeted movement of the punches, the pieces of skin are removed from the skin and finally removed from the individual punches with the help of an adhesive film.

Another device for removing individual pieces of skin from the skin is from US 2014/0081254 A1 famous. The device described in turn has a plurality of cutting elements which are introduced into the skin in a vertical direction and are guided out of the skin in the opposite direction for or before the removal of the required pieces of skin. According to the technical solution described, the cutting elements each have a scalpel, a punch or a laser or can even be designed as a combination of at least two of these cutting elements.

Another technical application for removing objects from the skin is the removal of tattoos. Due to the rapid growth of the tattoo market in recent years, the need for technical solutions to remove tattoos, some of which have been in fashion for a comparatively long time, is increasing to an almost equal extent located on the skin. It is essential for the techniques used that the color used for the tattoo or the color pigments are removed from the skin as painlessly and residue-free as possible. Furthermore, it is of great importance that the skin is only slightly injured when a tattoo is removed and that the risk of scarring is minimized.

Currently, tattoos are often removed using laser radiation applied to and into the skin. Different laser systems are used depending on the dye to be removed, in particular the color and the type and composition of the color pigments. The color pigments in the skin are usually destroyed with the help of the incident laser radiation, with photoacoustic, photomechanical and photoionizing effects being used. The pigment particles that remain in the skin after the laser radiation has destroyed or broken up the color pigments are finally transported away via the body's own lymphatic system. This removal of color pigment particles can usually take up to four to six weeks.

In addition to the known systems for removing a tattoo using laser radiation, methods are known in which both laser radiation and ultrasound are used to remove a tattoo. Such a device, which has both a laser light and an ultrasound source, is about from US 2014/0094718 A1 famous. With the help of the ultrasound source, high-frequency ultrasound waves are first generated, which are directed directly onto the skin areas provided with a tattoo and are intended to cause the tattoo dye to be detached from the cell walls in contact with it. An LED light source is then used to continuously generate high-intensity light, which in turn is directed directly onto the tattooed skin area, which is intended to achieve further decomposition of the tattoo dye.

It is often a problem with the methods known from the prior art for removing objects, such as pieces of skin, pathologies, particles, color pigments or other foreign bodies, that the objects intended for removal are not found or only found after a long time can be removed from the skin without leaving any residue in terms of time or equipment. In some cases, several treatment steps, a large number of repetitions and/or long treatments are necessary in order to be able to achieve the desired treatment success. In addition, injuries to the surrounding tissue and scarring represent not inconsiderable risks and problems of the known technical solutions.

Based on the technical solution known from the prior art for removing objects, for example pieces of skin, pathologies, particles, color pigments, such as are used in tattoo dyes, or other foreign bodies from the skin and the problems described above, the invention is the task The reason for this is to specify a device with which the corresponding treatments can be carried out comparatively easily and with only minor side effects for the treated and adjacent skin area. A correspondingly designed device should be versatile and enable the removal of different objects, in particular tattoo dyes, which can have different colors and color pigment properties.

In the realization and ultimately for the use of such a device, the body's own functions when removing a foreign body from the skin and when healing the lesions caused in the skin should also be taken into account or utilized to the greatest possible extent. Furthermore, it is of particular importance that with the help of the technical solution to be specified, a treatment success that is reproducible at least for many applications can be ensured while at the same time minimizing the risk for the patient to be treated. Furthermore, the structural design of a device for removing objects from the skin should be comparatively simple and, at least to a large extent, allow the use of already known components and effects. In order to achieve the greatest possible acceptance, it is also desirable for the device to be specified to be guaranteed to be safe, as intuitive and comfortable as possible for the practitioner to use.

The object described above is achieved by means of a device for removing at least one object or an agglomeration of objects, such as pieces of skin, pathologies and/or particles, from the skin according to claim 1. Advantageous embodiments of the invention are the subject matter of the dependent claims and are explained in more detail in the following description with partial reference to the figures.

The invention is based on a device for removing at least one object or agglomeration of objects, such as skin pieces, pathologies or exogenous particles, from the skin with a plurality of removal elements, in particular hollow needles and/or punches, which are arranged to be movable along a longitudinal direction of the removal elements . The removal elements are set up to penetrate a skin area under the application of force and to pick up the object in a target area below the skin surface, to separate it at least in areas from the surrounding skin area and to move this piece of skin in the direction of the skin surface. According to the invention, the device has been further developed in that a plunger element is provided with a contact surface, which at least limits movement of the skin surface when there is contact between the skin surface and the contact surface, in particular when the removal elements penetrate the skin, and that the plurality of removal elements is movable relative to the plunger element, an actuating element producing an operative connection between a drive and the plurality of removal elements being provided, by means of which the plurality of removal elements can be transferred into a first position and then into a second position. In the first position, at least one of the removal elements in the target area picks up the object, while in the second position, a lower end of the object facing the target area is generated in a plane with an uppermost skin layer adjoining the skin surface within one of at least one of the plurality of removal elements cavity is located. Furthermore, according to the invention, an ejection element is provided, which is set up to push the object out of the interior of the removal element due to a relative movement between the at least one removal element and the ejection element, the object at least almost maintaining its position within the cavity. After reaching the second position, the plurality of removal elements can preferably be moved into a third position in which the plurality of removal elements is in a rest, starting or starting position, particularly preferably protected inside a receptacle or a housing.

With the help of the technical solution according to the invention, it is thus possible to remove an object from a target area below the skin surface and preferably to position it in the area of the skin surface in such a way that an upper part of the object protrudes above the skin surface, while a lower part is still in the during cavity created during removal. The at least one object can finally be special simply removed from the cavity using a removal device. According to a particular embodiment, a plurality of objects, for example columnar pieces of skin, can be removed from the target area and positioned on the skin surface in such a way that, in a further step, the objects are arranged together and in the same alignment that they originally had within the skin , can be lifted out of the cavities and from the skin. A removal device that generates a vacuum, such as a vacuum vessel or a vacuum pump, or a plaster, sponge element and/or wound dressing is preferably provided for lifting at least one object from the skin.

It is essential for the positioning of the at least one object on the skin surface that a plurality of removal elements, in particular at least two hollow needles and/or at least two punches or a combination of at least one hollow needle with at least one punch, is provided as a removal element that is inserted into the skin penetrate, advance into the target area and separate or enclose at least one object to be removed, preferably a plurality of objects to be removed, in the target area at least in regions from the surrounding skin area in order to enable a subsequent movement of the at least one object relative to the skin. The object is moved within the skin in the direction of the skin surface and remains in the second position in which it only partially protrudes from the skin, so that a lower part facing the target area and a cavity created here still remains within the skin.

According to a particular embodiment, a plurality of removal elements are arranged in a row or in a square or rectangular array and can be moved at least partially together in the longitudinal direction of the removal elements. In a special embodiment, the distance between the outer surfaces of adjacent extraction elements is 300-500 μm.

Furthermore, it is advantageous if an adjustment element is provided for the targeted adjustment of a distance between the outer surfaces of adjacent removal elements. It is also conceivable that the removal elements, in particular hollow needles and/or punches used as such, are tubular and have an inner diameter that is equal to or smaller than 300 μm. Such a dimensioning of the removal elements has the advantage that an object received within a removal element can be removed from the skin without an additional cutting process being required on the underside of the object facing away from the skin surface. Rather, the adhesion forces inside a removal element, in particular a hollow needle or punch, are greater than the force that is required to separate the underside of an object to be removed from the adjacent tissue.

Furthermore, it is advantageous if the plurality of removal elements are arranged at a distance from one another and the inner diameter is dimensioned such that the skin is only slightly deformed and damaged when the removal elements enter and pass through. Since the objects to be removed from the skin are comparatively small, an unintentionally large deformation of the skin would result in either an incorrect or excessively large area of skin being perforated, or the objects to be removed being removed from the skin incompletely or only with large residues be able.

A particular development of the invention provides that at least one removal element, preferably each removal element, in particular each hollow needle and/or punch, is assigned an ejection element, at least part of which is arranged at least temporarily inside the removal element and can be moved relative to the removal element.

Such an ejection element ensures that, in the event of a relative movement between the respective removal element and the ejection element following the inclusion of an object in the removal element below the skin surface, the object, which is at least partially received within the removal element, is either completely or partially removed from the Removal element is conveyed out. The ejection element preferably has as many wipers as there are removal elements, in particular hollow needles or punches, so that a wiper is assigned to each removal element. According to a very special embodiment, the wipers are designed in a cylindrical shape and are at least temporarily surrounded by the associated extraction element. To remove an object from the removal element, in particular a hollow needle or punch, the at least one removal element is moved relative to the stripper, so that the enclosed object is pushed out in the direction of the open end of the removal element.

Furthermore, the invention has at least one plunger element, by means of which a skin area provided for contacting a tip of the at least one removal element is fixed or at least restricted in its freedom of movement. Preferably, the stamp element ment for fixing a skin area placed on the skin, which ensures that the skin moves only within a tolerance range as soon as at least one removal element is punctured in this skin area in the skin surface. According to a very specific development of the invention, the plunger element is arranged in such a way that the plurality of removal elements is located within the plunger element and the plurality of removal elements can be moved relative to the plunger element. The plunger element is very particularly preferably designed as a hollow cylinder with a round, oval or polygonal cross-section, with the majority of removal elements being moved parallel to the longitudinal axis of the hollow cylinder while penetrating the skin, so that the removal elements, in particular hollow needles and/or punches, preferably perpendicular to the skin surface in these penetrate. Furthermore, it is generally conceivable that the plunger element is designed in one piece with the ejection element, which removes the object removed from the skin from the at least one removal element, or is at least connected to it. It is also conceivable as an alternative or in addition for the stamping element to be part of a housing or at least to be connected to a housing.

According to a particular development of the invention, a removal element, which can be part of an array, for example a micropunch array, has an at least almost circular cross section. A piece of skin and/or tissue or another foreign body can in turn be picked up without any problems inside the removal element. Preferably, a stamping element is movably arranged inside the removal element, which is specifically movable in the longitudinal direction inside the removal element. What is essential about this special development of the invention is that the plunger element does not have direct contact with the skin surface before a piece of skin or tissue is picked up in the interior of the removal element, but rather by retracting the plunger element after the tip of the at least one removal element has pierced the skin or at least placed on it, a negative pressure is generated between the surface of the skin and the plunger element, so that the skin is drawn into the removal element at least in certain areas. The piece of skin or tissue or other foreign body then arranged inside the removal element, in particular a hollow needle or a micropunch, can later be pushed out again at least partially from the interior of the removal element due to a suitable relative movement between the removal element and the plunger element.

In a special embodiment of the invention, the actuating element, which at least temporarily connects a drive to the plurality of removal elements, has a gear mechanism with at least one movably mounted eccentric element. The movement of this eccentric element causes the removal elements, in particular hollow needles and/or punches, to be moved into the first and second position, with the eccentric element preferably being designed in such a way that the majority of removal elements each remain in the first and second position, at least for a short time, before another movement occurs.

It is also advantageous if the eccentric element is designed in such a way that the plurality of removal elements is then moved to the second position into a third position in which the plurality of removal elements are in a retracted, protected position relative to the skin surface, preferably in the inside a receptacle or housing. It is particularly advantageous if the eccentric element performs a closed movement sequence, for example an at least almost circular movement, while it moves the plurality of removal elements from a starting position to the first and second positions and then back to the starting position. With a suitable design of the eccentric element, it is conceivable in this connection to realize different movement speeds of the plurality of removal elements during their movement from one position to the next and/or from or into the starting position.

A special development provides that the drive has a manually operable handwheel. Turning the handwheel moves the actuating element and thereby the plurality of removal elements. Alternatively or in addition, it is conceivable that the drive has an electric motor, preferably a stepper motor. This is preferably supplied from an energy store, in particular a capacitor and/or an accumulator, with the electrical energy required to drive the actuating element and the plurality of removal elements. An external, wired power supply of the device for removing an object from the skin while the object is being removed is not required in this case.

Furthermore, it is advantageous if the removal elements, the adjusting element and/or a drive are set up in such a way that the object can be removed from the target area at a depth of 0.2 to 4 mm below the skin surface. Depending on the depth below the skin surface at which an object is located or from which an object emerges is to be taken, the penetration depth of the plurality of removal elements is adjusted as required.

Furthermore, a special embodiment provides a removal device to finally lift the at least one object from the skin or from a skin area into which a removal element, in particular a hollow needle and/or punch, was inserted or from the area ultimately created within the skin to remove cavity. The removal device is preferably designed in such a way that a plurality of objects arranged in a line or array in the area of the skin surface, at least a small section of which is still in the skin, are lifted off at least almost simultaneously.

The removal device preferably has at least one element for generating a pressure that is reduced compared to the ambient pressure, in particular a vacuum vessel and/or a vacuum pump, such as a ^VAC® pump.

Alternatively or in addition, the removal device has a plaster, a sponge element and/or a wound dressing.

The invention also relates to a device for generating microtraumas in at least one area of skin with a target area from which an object, in particular a foreign particle, such as a color pigment, can be removed with a device designed according to one of the embodiments described above should be removed. The corresponding device has means for generating the micro-traumas with an activator that is designed to introduce energy into the skin area. What is essential about this technical solution is that the activator is designed in such a way that the energy introduced into the skin area causes an increase in tissue pressure, an increase in the distance between collagen fibers and/or an exudation flow directed towards the target area. The device for generating microtraumas is preferably combined with the previously described device for removing an object from the skin, in particular integrated into one device. It is also conceivable to operate a corresponding device for generating microtraumas in a skin area and its special developments separately, in particular in an independent device that has all the components required for operation. Nevertheless, advantages can be achieved, among other things with regard to the number of required components, such as energy supply and control, if both devices are integrated into one device and, for example, are supplied with any electrical energy that may be required from an energy source.

With the aid of the technical solution described, it is possible in a particularly suitable manner to separate and/or set in motion objects such as foreign body particles, in particular pigments of a tattoo dye, from a skin area below the skin surface, in particular in a target area. The advantage here is that movements of objects are made possible or facilitated by the targeted increase in tissue pressure and/or an increase in the distance between collagen fibers and/or that an exudation flow directed towards the target area is generated, with which objects can be targeted in the target area can be moved. The objects thus advantageously brought together in the target area can be moved to the skin surface and lifted from there particularly effectively, painlessly and with few side effects using a device for removing at least one object from the skin, as described above.

In general, it is conceivable that the energy input takes place in such a way that at least one of the objects to be removed is not only moved but, under certain circumstances, is crushed, divided and/or destroyed.

According to a particular embodiment of the invention, the activator has at least one transmitter that emits sound waves in the ultrasonic range. The at least one transmitter of the activator is preferably designed in such a way that it emits sound waves with a frequency in a range from 3 to 10 MHz. With the help of the sound waves generated by the transmitter, microtraumas or lesions are generated in the target area and the object is thereby detached from a structure surrounding the object, for example a cell wall, and/or at least one property of the object is changed in such a way that the object can be removed, possibly in several Sharing, can be realized in the first place or at least made easier.

In a further development of the invention, it is conceivable in this context that the means for generating the microtraumas have at least one fluid which, as a result of the activation of the activator, experiences an increase in volume, is set in motion and/or experiences a change in properties. With the help of such a fluid, preferably at least in one area of the skin, especially in the target area, which can generally be liquid or gaseous, a particularly targeted treatment, removal or destruction of objects within the skin. For this purpose, the fluid selected according to need is subjected to a force by the activated activator due to the sound wave-bound energy input, so that the fluid or at least one of its components experiences an increase in volume, is set in motion and/or undergoes some other property change.

It is particularly advantageous if the means for generating the microtraumas have at least one fluid which is at least partially set in motion by the activator due to the energy input. In this case, the fluid is made to oscillate in a targeted manner within the skin, in particular within the target area, as a result of which at least one object to be removed from the skin is moved, detached from a surrounding structure, crushed, divided and/or destroyed.

In this context, it is provided in a very special way that the fluid has a plurality of spheres or particles with a size in the nanometer and/or micrometer range. Furthermore, it is advantageous if the spheres or particles have at least one lipid coating, one lipid shell and/or at least one lipid membrane. The designation size in the nanometer and/or micrometer range is to be understood within the meaning of the invention that the greatest extent of a sphere or a particle is in the nanometer range between 1 and 999 nm and in the micrometer range between 1 and 999 μm. It is fundamentally irrelevant here whether the spheres or particles are designed with an irregular outer contour, in the shape of a sphere, cube or cuboid or in some other way with a plurality of edges, curves and/or corners.

Preferably, the spheres or particles are at least partially filled with a proaptotic and/or toxic substance. If a fluid that has such spheres or particles is set in motion, in particular excited to vibrate, this can lead to movement, detachment from a surrounding structure, comminution, fragmentation and/or destruction in a targeted manner, especially after the substance has been released of the at least one object to be removed due to the release of the proaptotic and/or toxic substance. Thus, in turn, an object to be removed from the skin can be moved, detached, divided, destroyed and/or comminuted in a particularly effective manner by the targeted generation of microtraumas and finally removed from the skin in a comparatively simple manner.

Furthermore, it is conceivable that the spheres or particles have a surface marker that has annexin or phosphatidylserine, or that it has a macrophage binding motif. According to a further special embodiment, it is provided that the spheres or particles are at least partially filled with a gas or a gas mixture, which in turn preferably has the ingredients described above.

In addition, it is particularly advantageous if the activator has a transmitter and/or spheres or particles are selected so that at least temporarily sound waves are emitted which have a frequency which at least approximately corresponds to a resonant frequency of at least some of the spheres or particles . According to this embodiment, the transmitter emits ultrasonic waves with a frequency that excites the particles or spheres or the fluid provided in the spheres or particles, so that the fluid excited to shrink and/or the spheres or particles bursting open as a result , the object to be removed from the skin, in particular from the target area, is moved, detached, divided, destroyed or crushed.

According to a further embodiment, it is provided that the means for generating micro-traumas have at least one focusing unit for at least regionally focusing the sound waves emitted by the transmitter. It is therefore generally conceivable to couple sound waves diffusely into a skin area with a target area or else to couple them specifically into the target area and thus to introduce the required energy with the aid of the sound waves. Focusing is advantageous here, since the energy input can be effectively limited to a target area and the power required for the sound source can also be limited.

Furthermore, it is advantageous if a control unit is provided for the targeted activation of the actuating element and/or the drive of a device for removing at least one object from the skin. In this way it is conceivable to implement automated or at least partially automated operation, under certain circumstances taking into account specific properties of the skin areas from which at least one object is to be removed and/or of the at least one object.

It also appears particularly suitable if a control unit is provided for the targeted control of the means for generating microtraumas, in particular the activator, in at least partially automated operation. The energy is introduced with the aid of such a control unit, in particular taking into account the size, extent and shape of the target area and/or the properties of an object to be removed, for example the color and/or other properties of the color pigments of tattoo dyes.

• 1: Perspektivische Ansicht einer erfindungsgemäß ausgeführten Vorrichtung zur gezielten Entfernung von Objekten aus der Haut;
• 2: Schematische Darstellung des Ablaufs bei der Entfernung von Objekten aus der Haut, hier von Farbpigmenten eines Tätowierungsfarbstoffes, mithilfe einer erfindungsgemäß ausgeführten Vorrichtung;
• 3: Schnittansicht einer erfindungsgemäß ausgeführten Vorrichtung zur Entfernung wenigstens eines Objekts oder einer Agglomeration von Objekten aus der Haut;
• 4: Schnittansicht einer erfindungsgemäß ausgeführten Vorrichtung zur Entnahme eines Objekts oder einer Agglomeration von Objekten aus der Haut, bei der sich ein Array von Hohlnadeln in einer Stellung außerhalb des Gehäuses der Vorrichtung befindet;
• 5: Schnittansicht einer Mehrzahl von in Reihe angeordneten Hohlnadeln einer Hautstanze mit darin vorgesehenen Abstreifern eines Auswurfelements;
• 6: Schnittansicht einer Mehrzahl von in Reihe angeordneten Hohlnadeln einer Hautstanze mit darin vorgesehenen Abstreifern eines Auswurfelements im Entnahmeprozess;
• 7: Schnittansicht eines Stellelements, das einen Antrieb mit einer Mehrzahl von Hohlnadeln verbindet;
• 8: Hohlnadel in drei verschiedenen Ansichten;
• 9: Hohlnadel mit einer speziellen Ausnehmung im Bereich des Nadelschaftes.

The invention is explained in more detail below with reference to the exemplary embodiments and figures, without restricting the general inventive idea. show:

• 1 : Perspective view of a device designed according to the invention for the targeted removal of objects from the skin;
• 2 : Schematic representation of the process of removing objects from the skin, here color pigments of a tattoo dye, using a device designed according to the invention;
• 3 : sectional view of a device designed according to the invention for removing at least one object or an agglomeration of objects from the skin;
• 4 1: sectional view of a device designed according to the invention for removing an object or an agglomeration of objects from the skin, in which an array of hollow needles is located in a position outside the housing of the device;
• 5 : sectional view of a plurality of hollow needles of a skin punch arranged in a row with strippers of an ejection element provided therein;
• 6 : sectional view of a plurality of hollow needles arranged in a row of a skin punch with strippers of an ejection element provided therein in the removal process;
• 7 : sectional view of an adjusting element which connects a drive with a plurality of hollow needles;
• 8th : Hollow needle in three different views;
• 9 : Hollow needle with a special recess in the area of the needle shaft.

1 shows a perspective view of a device 1 for the targeted removal of objects 5 from the skin. The objects 5 to be removed from the skin can be pieces of skin, pathologies, particles, in particular color pigments from tattoo dyes, or other foreign bodies. with the inside 1 With the device 1 shown, it is above all also possible to selectively remove individual pieces of skin or rows and/or arrays of pieces of skin from healthy areas of the skin and to transplant these pieces of skin into injured areas of skin, such as those that have burns.

It is also possible to remove tattoos, and here in particular the color pigments arranged in the skin, with the device shown. The device 1 shown has a plurality of hollow needles as removal elements 2, which can also be referred to as micro- or skin punches, and which can be inserted in a targeted manner into skin areas 4 that are located below the skin surface 3 and represent target areas.

To remove objects 5 from the skin, for example pieces of skin with color pigments of a tattoo dye in them, a stamp element 7 connected to the housing is used to fix the skin on the skin surface 3 and the plurality of removal elements 2, here hollow needles, which are held by the stamp element 7 are surrounded, pierced to a first position in the skin. The removal elements 2 are then moved together with the skin pieces located therein in the direction of the skin surface 3, with the underside of the skin pieces, which each represent the lower end 11 of the object 5 to be removed, being separated from the adjacent tissue. This is possible because the inner diameter of the hollow needles used as removal elements 2 is chosen so small that the adhesion forces inside 6 of the removal elements 2 are greater than the tear-off force required to separate the piece of skin from the adjacent tissue.

In a second position, in which the individual pieces of skin are only partially in the skin, while the larger part protrudes above the skin surface 3, the pieces of skin are ejected using an ejection element 12, which has a stripper assigned to each removal element, here each hollow needle pushed out the removal elements 2 or removal elements 2 pulled over the pieces of skin, so that the pieces of skin remain in their position and arrangement. The array of skin pieces can finally be lifted off the skin surface 3 with the aid of a removal device 15 which has means for generating a negative pressure, or a suitable plaster and/or adhesive strip. In the 1 The device 1 shown can be used in this way both for the transplantation of pieces of skin and for the removal of tattoos, with the individual removal steps being repeated several times.

In addition, the in 1 Device 1 shown has means for generating microtraumas 16 with an activator 17 which has a transmitter which either diffuses sound waves in the ultrasonic range into a skin area 4 or focuses them into a target area located in the skin area 4 bid can send out. Such an activator 17 causes microtrauma in the skin areas 4 into which the sound energy is introduced, increasing tissue pressure, increasing a distance between collagen fibers and/or causing an exudation flow directed towards the target area. In this way, it is possible to detach objects 5 to be removed from the skin in a suitable manner from the adjacent tissue prior to removal, to divide, crush, destroy and/or to set them in motion, so that these objects 5 can be removed or at least simplified. A service of the in 1 The device shown can be activated either by manual actuation of the drive 9 or with the aid of a control unit 19, which sends a control signal to the device 1, in particular the activator 17 and/or the drive 9, which in this case is preferably powered by a battery supplied has an electric motor, sends done. When using a central control unit 19, which can also be integrated into the housing of the device 1, automated or at least partially automated operation of the device 1 is possible.

On the individual components of the in 1 The device illustrated is discussed in detail below with reference to the views shown in various figures.

First is related to 2 schematically describes the procedure for removing objects 5 from the skin, here color pigments of a tattoo dye, using a device 1 designed according to the invention. According to the 2 Technical solution shown, two films are first applied to the skin, of which a first sticks to the skin and a second to the first film. A device designed according to the invention is then placed on the second film facing away from the skin and the array-shaped removal elements 2 of the device 1, here in the form of hollow needles, are inserted into the desired target areas below the skin surface 3 perpendicular to the two films and the skin surface underneath. In this case, below the skin surface 3 pieces of skin, which also contain the color pigments of the tattoo dye, are separated from the tissue surrounding the removal elements 2 on the circumference and enclosed inside the hollow-cylindrical removal elements 2 .

Now the second foil, which sticks to the first foil on the side facing away from the skin, is pulled off in the areas that are not above the punched-out columnar pieces of skin, and the removal elements, here hollow needles, are pulled out of the skin. On the skin there is now the first film glued directly to the skin and, above the columnar pieces of skin, the second film glued to the first film, specifically in the form of a plurality of circular discs arranged in an array. A third film is then glued to this composite film and used to pull the two lower films and the columnar pieces of skin adhering to the first film, containing the color pigments of a tattoo dye, out of the skin. If the method steps described above are repeated several times and preferably in adjacent skin areas 4, even large-area tattoos can be removed comparatively gently in this way, above all without the use of laser radiation.

After a tattoo has been removed, the corresponding skin area 4 can be easily regenerated using the known means, in particular without skin irritations or scars remaining.

Furthermore, the use of a device 1 designed according to the invention for removing at least one object 5 from the skin also offers the advantage that the individual pieces of skin are already moved from the skin to the surface of the skin when the removal elements 2 are removed and are pushed out of the removal elements 2 in this way that the pieces of skin are still located with their lower part within the punched-out cavities 13, while the upper part projects beyond the surface of the skin 3. Finally, an array of skin pieces positioned in this way can be lifted directly from the skin surface 3 relatively easily with a vacuum unit and/or an adhesive strip or a suitable plaster, without the use of a plurality of adhesive films, as described above, in particular the first and second films , is required. Both the arrangement of the pieces of skin in the array and the orientation of the tissue within the pieces of skin are retained.

The removal of objects 5 from the skin can also be improved by coupling ultrasonic waves into the target area or areas, which in particular increases tissue pressure within the skin and increases the distance between collagen fibers. As a result of these changes in the skin, which can be achieved in a targeted manner by introducing sound waves into the target areas, an exudation current can also be generated within the skin, which causes objects 5, for example color pigments from tattoo dyes, to be moved and preferred in the skin be directed to the target area. Due to this additional measure, which is generally also taken by itself can be carried out, it is possible to detach objects 5 within the skin from the structures surrounding them, for example cell walls, to set them in motion and/or to collect a comparatively large number of objects 5 within a target area in order to then remove them from the skin in a targeted manner be able.

Advantageously, this process of generating microtraumas in the skin, which leads to an increase in tissue pressure, a widening of the distance between individual collagen fibers and/or initiation of an exudation flow directed into a desired skin area 4, in particular a target area, is thereby achieved supports that first a fluid 18 is introduced into the target area, which has spheres, particles and/or in particular so-called microbubbles, ie microbubbles with a diameter of approximately 1 to 10 μm. Ultrasonic waves are then radiated into the target area with a transmitter provided as an activator 17 at a frequency which essentially corresponds to a resonant frequency of the spheres, particles and/or microbubbles. The spheres, particles and/or microbubbles are excited to a maximum vibration due to the sound waves and are at least partially destroyed. This can in particular further increase the formation of an exudation stream, especially when the spheres, particles and/or microbubbles are filled with a liquid or gas and contain active ingredients that increase tissue pressure and the distance between the individual lead collagen fibers.

3 shows a sectional view of a device 1 for removing at least one object 5 or an agglomeration of objects 5, such as pieces of skin, pathologies or particles foreign to the body, for example color pigments from tattoo dyes, from the skin, which can be removed via a plurality of removal elements 2 arranged in a row, here hollow needles, features. The removal elements 2 are designed in the form of hollow cylinders so that, after penetrating the skin, they receive correspondingly cylindrical objects 5 , such as pieces of skin with color pigments of a tattoo dye, in their interior 6 . The individual extraction elements 2 have an inside diameter that is no greater than 300 μm. Due to this inner diameter, objects 5, in particular pieces of skin, can be moved from a target area below the skin surface 3 towards the skin surface 3 without additional means being required to separate the underside or the lower end 11 of the object 5 from the adjacent tissue. This is possible because with such a dimensioning, the adhesion forces inside the removal elements 2, here hollow needles, are greater than the tear-off forces that are required to separate the underside of the objects 5 picked up from the adjacent tissue areas. If the removal elements 2 are pulled out of the skin, the objects 5 received in the removal elements 2 therefore remain inside 6 of the hollow-cylindrical removal elements 2. The removal elements 2 filled with objects 5, in particular with pieces of skin containing color pigments of a tattoo dye, can be removed with the in 3 Pull the device 1 shown out of the skin far enough that the undersides or lower ends 11 of the individual cylindrical objects 5 facing the target areas are essentially in a plane with the skin surface 3 or are at least arranged in an upper skin layer, with the objects 5 are still arranged with their lower part within the cavity 13 produced. In this position, the individual objects 5 are ejected from the removal elements 2 with the aid of an ejection element 12 , the removal elements 2 being moved back in the direction of the housing of the device 1 via the cylindrical scrapers of the ejection element 12 .

With the device according to 3 an array of objects 5 can thus be removed from a skin area 4 and arranged in the area of the skin surface 3 or an upper skin layer, so that the individual objects 5 project beyond the skin surface 3 . In a final step, objects 5 positioned in this way can be lifted off the skin comparatively easily using a removal device 15, which generates negative pressure and/or has a plaster or an adhesive strip, whereby both the array-like arrangement of the objects 5 and the inner structure of the Objects 5 is retained.

In the 3 The device 1 shown for removing an object 5 or an agglomeration of objects 5 from the skin is designed in the form of a skin punch that can be moved in the vertical direction and that can be moved in the longitudinal direction by means of a plurality of removal elements 2 in the form of hollow needles that are mounted inside a housing and can be moved via a piston drive has. At the lower end, the device 1 has a plunger element 7 which has an annular contact surface 8 and can be placed on the skin area 4 in order to fix the skin, in which at least one object 5 is to be removed.

After the skin area 4 has been fixed, the removal elements 2 , here hollow needles, are guided into the interior of the skin perpendicularly to the skin surface 3 by pressing the plunger. The objects 5 recorded in the interior 6 of the extraction elements 2 are thereby removed by a subsequent movement of the Removal elements 2 in the form of hollow needles are transferred in the opposite direction into a position in which the underside or lower end 11 of the picked-up objects 5 still remain in the cavities 13 created by the removal elements 2, while their upper sides protrude above the skin surface 3 . From this position, the removal elements 2 are moved further out of the skin, with the scrapers of an ejection element 12 arranged inside 6 of the removal elements 2 ensuring that the objects 5 removed from the target area in the skin remain in their position and alignment and relative to the moved ones Removal elements 2 are ejected from these.

The drive 9 of the in 3 The device 1 shown has a piston element which can be moved perpendicularly to the skin surface 1 by pressing against a spring force until a stop stops the movement. After picking up the objects 5 to be removed from the skin in the target area, the removal elements 2 are moved out of the skin again due to the spring force acting on them.

4 shows a sectional view of a device 1 designed according to the invention for removing an object 5 or an agglomeration of objects 5 from the skin, in which the array of removal elements 2, which are designed in the form of hollow needles, is in a position outside the housing of the device 1 . For the targeted removal of objects 5 from the skin, the device 1 has a plurality of removal elements 2 , here hollow needles, which are arranged in a row inside the housing of the device 1 . By actuating a drive 9 with a hand wheel (not shown in this view), a force is exerted on the plurality of removal elements 2 via an actuating element 10, so that these are moved downwards in the longitudinal direction. Furthermore, an adjusting element 14 is provided, with which a distance between the individual removal elements 2 of the line-shaped array can be varied as required.

Before actuating the drive 9, the in 4 The device 1 shown is first placed on the skin area 4 to be treated with the contact surface 8 of a plunger element 7 located at the lower end. The skin surface 3 is fixed with the aid of the plunger element 7 in such a way that movements of the skin, in particular due to the penetration of the removal elements 2 into the skin, are limited at least to a tolerable extent.

After the plunger element 7 has been put on and the skin has been fixed in place as a result, the plurality of removal elements 2 are moved downwards by manual actuation of the drive 9 and are thus guided into the skin. At a depth of 0.2-4 mm below the skin surface 3, the individual hollow-cylindrical removal elements 2 each take an object 5 in the interior 6, for example a piece of skin with color pigments of a tattoo dye located therein. After reaching this first position, in which the removal elements 2 are at their maximum penetration depth in the target area, they are moved to a second position in which the lower part of the recorded objects 5 is still in the area covered by the removal elements 2 within the skin generated cavities 13 are located, while the upper parts already protrude from the skin surface 3. When the movement of the removal elements 2 continues, the tops of the picked-up objects 5 come into contact with wipers of an ejection element 12 mounted inside 6 of the removal elements 2, so that the individual objects 5 remain in their position while the removal elements 2, here hollow needles, continue to move move up in the direction of the housing of the device 1 or skin punch. As soon as the removal elements 2 are in the starting position, protected inside the housing of the device 1, the removal process is complete.

As will be explained in detail below, the in 4 shown device as a drive 9 via a handwheel, which is in operative connection via the actuating element 10 with the plurality of removal elements 2 in the form of hollow needles. The actuating element 10 in turn has a gear with an eccentric disk, which performs a specific movement due to a rotation of the hand wheel. By turning the hand wheel, the removal of an object 5 or an agglomeration of objects 5 from the skin can be initiated in a targeted manner, with the individual steps of picking up the objects 5, positioning the objects 5 in the area of the skin surface 3 and pushing the objects 3 out of the removal elements 2 are automatically implemented due to the suitable design of the drive 9 and the actuating element 10. A practitioner only has to place the device 1 or skin punch with its plunger element 7 on the skin surface 3 above the skin area 4 from which at least one object is to be removed and actuate the drive 9 so that all method steps are implemented correctly. In particular, it is always ensured that on the one hand the removal elements 2 are introduced into the required depth of the skin and on the other hand the positioning and pushing out of the objects 5 takes place in the area of the skin surface 3 . Regardless of whether the drive 9 and the actuating element 10 have mechanical, electromechanical or electrical components, this is the case Always ensure the proper removal of objects 5 from the skin without the practitioner having to make special settings for this.

In 5 a sectional view of a plurality of removal elements 2 arranged in a row in the form of hollow needles of a device 1 designed according to the invention or skin punch with strippers of an ejection element 12 arranged therein is shown. As soon as the removal elements 2 have been punctured to the maximum penetration depth in the target area of the skin, they are in this position. The objects 5 to be removed from the skin are located in the interior 6 of the hollow-cylindrical removal elements 2 and have a cylindrical or columnar configuration. After the objects 5 have been picked up, the removal elements 2 are first moved into a second position, this movement taking place relative to the strippers arranged inside 6 of the removal elements 2 .

In this context shows 6 the same arrangement of removal elements 2 and scrapers of an ejection element 12, wherein the removal elements 2, here hollow needles, are already in a second position in the removal process, into which they were brought by a relative movement along the individual cylindrical wipers, and in which the originally Inside 6 of the removal elements 2 recorded objects 5 were pushed out using the scraper.

Within the housing, the individual scrapers are positioned and arranged in such a way that, provided that the stamping element 7 has been correctly placed on the skin surface 3, the upper ends of the removed objects 5 protrude beyond the skin surface 3 after removal from the skin, so that the corresponding array is at the front Objects 5 can be removed relatively easily from the cavities 13 created by the removal elements 2 and can be lifted off the skin surface 3 .

7 also shows a sectional view of an adjusting element 10, which connects a drive 9, here a handwheel (not shown), to a plurality of removal elements 2 in the form of hollow needles, so that actuation of the rotary wheel causes the adjusting element 10 to move the removal elements 2 in the longitudinal direction and thus in a suitable manner relative to the skin from which an object 5 is to be removed.

The actuating element 10 has an eccentric element 20 in the form of an eccentric disk which has an egg-shaped peripheral contour and has a cam 21 on its surface.

When the handwheel provided as the drive 9 is actuated, the disk-shaped eccentric element 20 rotates counterclockwise, the removal elements 2 initially being moved upwards into the housing of a device 1 or skin punch designed according to the invention due to a spring force emanating from a helical spring. After approximately 90° rotation of the eccentric disk, the cam 21 engages the stop 22 of a tensioning mechanism and pushes the stop upwards, thereby preloading a spring of the tensioning mechanism.

When the rotational movement of the eccentric element 20 continues, the tensioning mechanism is unlocked and the array of removal elements 2 of the skin punch is abruptly moved downwards, into the skin during operation. As soon as the eccentric element 20 is in a position in which the distance between its pivot point and its outer circumference is at a maximum, the tips of the removal elements 2 are also at the maximum penetration depth below the skin surface 3.

As the rotation of the eccentric element 20 continues, the distance between the pivot point of the disc and the stop 22 decreases, so that the removal elements 2 are again moved upwards in the direction of the housing of the skin punch under the action of spring force.

using the in 7 With the adjusting element 7 shown, an array of removal elements 2, in particular hollow needles or micro-punches, of a skin punch can be moved in a targeted manner in order to remove objects 5 from the skin in an array-like arrangement and arrange them in the area of the skin surface 3, as has already been described above.

If the skin punch is finally removed from the skin surface 3, the array of objects 5 positioned in this way can be removed from the skin surface comparatively easily, for example using an adhesive strip, with the individual objects 5 being removed from the individual cavities 13 without leaving any residue.

With the positioning element 10 shown, it is possible for a practitioner to remove an object 5 or an agglomeration of objects 5 from the skin in a comparatively simple manner by turning a rotary wheel. To remove at least one object 5 or an agglomeration of objects 5 from the skin, the skin punch is turned with the rotary wheel drive 9 and the in 7 The actuating element 10 shown is placed with the contact surface 8 of the plunger element 7 on the skin surface 3 and the rotary wheel is actuated, so that the hollow-needle-shaped removal elements 2 penetrate the skin to the required depth comparatively quickly. By turning the hand wheel further, the removal elements 2 are guided out of the skin again, as described above, and the objects 5 are arranged in the area of the skin surface 3 so that they can be lifted from the skin, for example using an adhesive strip. The required positioning of the extraction elements 2, in particular the adjustment of the penetration depth, is therefore not necessary, since the extraction elements 2 are always moved into the required position due to the arrangement relative to the plunger element 7.

In the 8th and 9 special hollow needles are shown, which can preferably be used as removal elements 2 and are particularly suitable for the implementation of the invention. Here shows 8th a hollow needle in three different views, namely in 8 a) in a side view, in 8 b) in a front view and in 8c) in an oblique perspective view. What is essential about the hollow needle shown is the special shape of the needle tip, with the two opposite tips forming an acute angle, which, as shown in 8 a) shown, is preferably 24°, while the recesses arranged between the tips have an at least approximately parabolic contour.

9 shows a special needle that has at least one recess along the needle shaft, which can serve as a cavity for receiving a sample during sampling. At the front end of the hollow needle there is in turn a needle tip which is suitable for allowing the hollow needle to penetrate the skin easily. A cutting edge is provided above the recess provided for sampling, which forms a hollow space during sampling, which enables the desired skin sample to be separated.

Reference List

1

Device for removing at least one object from the skin

2

removal element

3

skin surface

4

skin area

5

object

6

interior of the extraction element

7

stamp element

8th

contact surface

9

drive

10

actuator

11

lower end of the object

12

ejection element

13

cavity

14

adjustment element

15

removal device

16

Means for generating microtraumas

17

activator

18

Fluid

19

control unit

20

eccentric element

21

cam

QUOTES INCLUDED IN DESCRIPTION

This list of the documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• WO 2016/033584 A1 [0003]
• US 2014/0081254 A1 [0004]
• US 2014/0094718 A1 [0007]

Claims (25)

Device for removing at least one object (5) or agglomeration of objects (5), such as skin pieces, pathologies or exogenous particles, from the skin with a plurality of removal elements (2), in particular hollow needles and/or punches, which run along a longitudinal direction of the Removal elements (2) are movably arranged and are set up to penetrate an area of skin (4) when force is applied and to pick up the object (5) in the interior (6) in a target area, to separate at least areas from the surrounding area of skin (4) and to separate this piece of skin to move in the direction of the skin surface (3), characterized in that a stamping element (7) is provided with a contact surface (8) which, when there is contact between the skin surface (3) and the contact surface (8), causes a movement of the skin surface (3 ) at least limited and that the plurality of removal elements (2) relative to the plunger element (7) is movable, with an operative connection between e An actuating element (10) producing the drive (9) and the plurality of extraction elements (2) is provided, by which the plurality of extraction elements (2) are moved to a first position in which at least one of the extraction elements (2) in the target area removes the object (5th ) picks up and then into a second position in which a lower end (11) of the object (5) facing the target area is in a plane with an uppermost skin layer adjoining the skin surface (3) within one of at least one of the plurality of removal elements ( 2) the cavity (13) produced is located, and that an ejection element (12) is provided, which is set up to remove the object (5) from the Interior (6) to push the removal element (2), wherein the object (5) maintains its position within the cavity (13) at least almost. device after claim 1 , characterized in that the plurality of extraction elements (2) are arranged in series or in a square or rectangular array. device after claim 1 or 2 , characterized in that a distance between the outer surfaces of adjacent removal elements (2) has a value of 300 to 500 µm. Device according to one of the preceding claims, characterized in that an adjusting element (14) is provided for the purposeful setting of a distance between the outer surfaces of adjacent extraction elements (2). Device according to one of the preceding claims, characterized in that the plurality of sampling elements (2) are tubular and have an internal diameter which is equal to or smaller than 300 µm. Device according to one of the preceding claims, characterized in that the actuating element (10) has a gear with at least one movably mounted eccentric element which is set up to move the removal elements (2) into the first and second position by moving the eccentric element . Device according to one of the preceding claims, characterized in that the drive (9) has a manually operable handwheel. Device according to one of the preceding claims, characterized in that the drive (9) has an electric motor. Device according to one of the preceding claims, characterized in that the removal elements (2) and/or the adjusting element (10) are set up in such a way that the object (5) is located at a depth of 0.2 to 4 mm below the skin surface (3). can be found in the target area. Device according to one of the preceding claims, characterized in that a removal device (15) is provided in order to remove the at least one object (5) from the cavity (13). device after claim 10 , characterized in that the removal device (15) has at least one element for generating a pressure that is reduced compared to the ambient pressure, a plaster, a sponge element and/or a wound dressing. Device for generating micro-traumas in at least one skin region (4) in which the target area provided for the removal of an object (5) with a device according to one of the preceding claims is located, with means for generating the micro-traumas (16) which have a have an activator (17) which is designed to introduce energy into the skin area (4), characterized in that the activator (17) is designed in such a way that the energy introduced into the skin area (4) causes an increase in tissue pressure, a increasing a distance between collagen fibers and/or causing a flow of exudation towards the target area. device after claim 12 , characterized in that the activator (17) has at least one transmitter which emits sound waves in the ultrasonic range. device after claim 12 or 13 , characterized in that the activator (17) has at least one transmitter which emits sound waves with a frequency in a range from 3 to 10 MHz. Device according to one of Claims 12 until 14 , characterized in that the means for generating the micro-trauma (16) have at least one fluid (18) which, due to activation caused by the energy input from the activator (17), experiences an increase in volume at least in regions, is set in motion and/or undergoes a property change. device after claim 15 , characterized in that the means for generating the micro-traumas (16) have at least one fluid (18) which is caused to vibrate at least partially as a result of the activation. device after claim 15 or 16 , characterized in that the fluid (18) has a plurality of spheres or particles with a size in the nano and / or micrometer range. device after Claim 17 , characterized in that the spheres or particles have at least one lipid coating, a lipid shell and/or at least one lipid membrane. Device according to one of Claims 15 until 18 , characterized in that the fluid (18) comprises a plurality of spheres or particles which are at least partially filled with a proaptotic and/or toxic substance. Device according to one of claims 17 until 19 , characterized in that the spheres or particles have a surface marker that has annexin or phosphatidylserine, or a macrophage-binding motif. Device according to one of claims 17 until 20 , characterized in that the spheres or particles are at least partially filled with a gas or gas mixture. Device according to one of claims 17 until 21 , characterized in that the activator (17) has a transmitter which is set up to emit sound waves having a frequency which corresponds at least approximately to a resonance frequency of at least part of the spheres or particles. Device according to one of Claims 13 until 22 , characterized in that the means for generating micro-traumas (16) have at least one focusing unit for at least regionally focusing the sound waves emitted by the transmitter. Device according to one of the preceding claims, characterized in that a control unit (19) is provided for the targeted activation of the drive (9) and/or the adjusting element (10). Device according to one of Claims 12 until 24 , characterized in that a control unit (19) for the targeted control of the means for generating micro-traumas (16), in particular the activator (17), is provided in an at least partially automated operation.

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