JP6972411B1 - Microneedle manufacturing method and microneedle manufacturing equipment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method for manufacturing a protrusion holder and an apparatus for manufacturing the protrusion holder, which can smoothly separate the support member and the protrusion holder. SOLUTION: This is an apparatus EA for manufacturing a protrusion holding body CB in which a protrusion CV is formed, and a base material BM is supported by a support member 22 having a support surface 22A in which a recess 22B corresponding to the protrusion CV is formed. The material supporting means 20 for carrying out the material supporting step and the base material BM are pressed in the direction toward the support surface 22A to fill the recess 22B with the plastic material PM, and the protrusion CV is formed from the plastic material PM to form a protrusion. The support member 22 is provided with a pressing means 30 for carrying out a pressing step of forming the holding body CB, and the support member 22 is formed with a punch hole 22C through which the support surface 22A and the recess 22B can be pulled out, and the punch hole 22C is formed with a fluid. Is provided, and the contact releasing means 90 for carrying out the adhesion releasing step of releasing the adhesion between the protrusion holding body CB and the support member 22 is provided. [Selection diagram] Fig. 1

Description

The present invention relates to a manufacturing apparatus for manufacturing methods and microneedles of the microneedle (hereinafter, referred to herein as the microneedles as "projection reservoir of".).

A technique for manufacturing a protrusion holder on which a needle-shaped protrusion is formed is known (see, for example, Patent Document 1).

Japanese Unexamined Patent Publication No. 2019-170795

In the manufacturing technique of the protrusion holder disclosed in Patent Document 1, the thermoplastic resin 3 (plastic material) is pressed against the recess 2 (support member) to form a microneedle (protrusion holder), and then the protrusion is formed from the support member. When separating the holding bodies, if the support members and the protrusion holding bodies are in close contact with each other and the protrusion holding bodies cannot be smoothly separated, the protrusion holding bodies may be broken or damaged, and the protrusion holding body having a desired shape may be obtained. It causes the inconvenience that it cannot be formed.

An object of the present invention is to provide a method for manufacturing a protrusion holder and an apparatus for manufacturing the protrusion holder, which can smoothly separate the support member and the protrusion holder.

The present invention has adopted the configuration described in the claims.

According to the present invention, since the fluid is supplied to the punched hole to release the adhesion between the protrusion holder and the support member, the support member and the protrusion holder can be smoothly separated from each other.

(A) to (D) are explanatory views of the manufacturing apparatus of the protrusion holding body which concerns on one Embodiment of this invention, and the operation explanatory drawing of the apparatus. (E) to (G) are explanatory views of modified examples.

Hereinafter, an embodiment of the present invention will be described with reference to the drawings.
The X-axis, Y-axis, and Z-axis in the present embodiment are orthogonal to each other, the X-axis and the Y-axis are axes in a predetermined plane, and the Z-axis is an axis orthogonal to the predetermined plane. do. Further, in the present embodiment, "up" is "down" in the direction of the arrow on the Z axis when the direction is shown without specifying the figure, based on the case of viewing from the front direction in FIG. 1 parallel to the Y axis. Is the opposite direction, "left" is the arrow direction of the X axis, "right" is the opposite direction, "front" is the middle front direction parallel to the Y axis, and "rear" is the opposite direction. It should be noted that FIGS. 1 (B) to 1 (G) in which the arrow indicating the direction is not shown are all views viewed from the same direction as in FIG. 1 (A).

The EA for manufacturing a protrusion holding body (hereinafter, also simply referred to as “manufacturing device”) of the present invention is an device for carrying out a method for manufacturing a protrusion holding body CB on which a protrusion CV is formed, and includes a plastic material PM. A material support step of supporting the base material BM by a support member 22 having a material transfer means 10 for carrying out a material transfer process for transporting the base material BM and a support surface 22A in which a recess 22B corresponding to the protrusion CV is formed. The material supporting means 20 and the base material BM are pressed in the direction toward the support surface 22A to fill the recess 22B with the plastic material PM, and the protrusion CV is formed from the plastic material PM to form the protrusion holding body CB. The pressing means 30 for carrying out the pressing step to be formed, the heating means 40 for carrying out the heating step for heating the plastic material PM, the positioning means 50 for carrying out the positioning step for positioning the support sheet BS with respect to the support surface 22A, and the protrusions. By immersing the holding body CB in water WT as an leaching medium, the separating means 60 for carrying out the separating step for separating the holding body CB from the support member 22, the cooling means 70 for carrying out the cooling step for cooling the plastic material PM, and the plastic material PM. The leaching means 80 for carrying out the leaching step using the plastic material PM as a porous body, and the contact releasing step for supplying gas as a fluid to the punching hole 22C to release the adhesion between the protrusion holding body CB and the support member 22. It is provided with the contact release means 90 to be carried out, and is arranged in the vicinity of the base material supply means PS for carrying out the base material supply step of supplying the BM.
In the base material BM, the plastic material PM is laminated on one surface of the support sheet BS. Further, the support sheet BS of the present embodiment is made of paper as a permeable member having a permeability capable of transmitting at least one of a liquid and a gas. Further, the plastic material PM has thermoplasticity because polylactic acid (PLA) is the main component, and polyethylene glycol PG as a leaching material that leaches into water WT (see the enlarged view of FIG. 1 (D)). Contains. The plastic material PM of the present embodiment is a mixture of two components, polylactic acid and polyethylene glycol PG, and the ratio thereof is 5: 5.

The material transporting means 10 is composed of a plurality of arms, and within the working range, a so-called articulated robot as a drive device that can displace what is supported by the tip arm 11A, which is a working portion, at any position and at any angle. A robot 11 and a holding plate 12 having a holding surface 12A supported by a tip arm 11A and capable of suction holding by a decompression means (holding means) (not shown) such as a decompression pump or a vacuum ejector are provided, and a plastic material PM is supported. The base material BM is placed on the support member 22 in contact with the 22A.

The material supporting means 20 includes a base 21 on which the step portion 21A is formed, and a support member 22 that is fitted and supported in the step portion 21A and has a recess 22B formed in the support surface 22A. The support member 22 is formed with a hole 22C that can be removed from both the support surface 22A and the recess 22B.

The pressing means 30 includes a linear motor 31 as a driving device and a pressing member 32 supported by the output shaft 31A thereof. In this embodiment, the pressing member 32 is made of a transparent material.

The heating means 40 includes a heating device 41 composed of a coil heater, a heating side of a heat pipe, and the like arranged inside the base 21.

The positioning means 50 is composed of an image pickup means such as a camera or a projector, various sensors such as an optical sensor and an ultrasonic sensor, and a detection device 51 supported by a pressing member 32 via a bracket 51A as a drive device. The XY table 52 and the rotation motor 53 as a drive device supported by the output base 52A of the XY table 52 and supporting the base 21 by the output shaft 53A are provided, and the support member 22 is linearly moved in the XY plane. Alternatively, the support member 22 is moved in a curved line and is rotated in the XY plane.

The separating means 60 is a so-called articulated robot as a drive device which is composed of a plurality of arms and can displace what is supported by the tip arm 61A, which is a working portion, at any position and at any angle within the working range. The 61 is provided with a holding plate 62 supported by the tip arm 61A and having a holding surface 62A which is supported by a pressure reducing means (holding means) (not shown) such as a pressure reducing pump or a vacuum ejector.

The cooling means 70 includes a cooling device 71 including a Pelche element provided inside the holding plate 62, a cooling side of a heat pipe, and the like.

The leaching means 80 includes a water WT and a container 81 for receiving the water WT.

The close contact releasing means 90 is composed of a pressurizing pump, a turbine, or the like, and is formed in a pressurizing means 91 capable of supplying gas via a pipe 91A and a base 21, so that the pipe 91A and the punching hole 22C communicate with each other. It is equipped with a communication port 92.

The operation of the above-mentioned protrusion holding body manufacturing apparatus EA will be described.
First, with respect to the manufacturing apparatus EA in which each member is arranged at the initial position shown by the solid line in FIG. 1 (A), the user of the manufacturing apparatus EA (hereinafter, simply referred to as “user”), an articulated robot, or a belt conveyor. After the base material BM is supplied onto the base material supply means PS as shown in the figure, the user signals the start of automatic operation via an operation means (not shown) such as an operation panel or a personal computer. Enter. Then, the material transporting means 10 drives the articulated robot 11 and the decompression means (not shown) to move the holding plate 12 to bring the holding surface 12A into contact with the support sheet BS, and the holding surface 12A sucks and holds the base metal BM. Then, as shown by the alternate long and short dash line in FIG. 1 (A), after the base metal BM is placed on the support surface 22A of the support member 22, the drive of the decompression means (not shown) is stopped and the holding plate 12 is placed in the initial position. Return to. Next, the pressing means 30 drives the linear motion motor 31 to lower the pressing member 32, and as shown in FIG. 1B, the pressing member 32 presses the base material BM in the direction toward the support surface 22A. The plastic material PM is filled in the recess 22B. At this time, the heating means 40 drives the heating device 41 to heat and soften the plastic material PM, so that the plastic material PM can be easily filled in the recess 22B. After that, the positioning means 50 drives the detection device 51 to detect the position of the support sheet BS, and the positioning means 50 drives the XY table 52 and the rotation motor 53 based on the detection result, and the support sheet BS is predetermined. The support member 22 is moved so that the recess 22B (protrusion CV) is arranged at the position of. As a result, the protrusion CV and the base FD that supports the protrusion CV are formed from the plastic material PM, and the protrusion holder CB having the protrusion CV formed on the support sheet BS is formed. Next, the pressing means 30 drives the linear motion motor 31 to return the pressing member 32 to the initial position, and then the heating means 40 stops driving the heating device 41.

Then, the separating means 60 drives the articulated robot 61 and the decompression means (not shown), and as shown in FIG. 1C, the holding plate 62 is brought into contact with the protrusion holding body CB, and the protrusion holding body CB is brought into contact with the holding surface 62A. After adsorbing and holding the gas, the adhesion releasing means 90 drives the pressurizing means 91 and supplies gas from the punching hole 22C. Next, the separating means 60 drives the articulated robot 61 to separate the protrusion holding body CB from the support member 22. At this time, the protrusion holding body CB moves as the holding plate 62 moves while the contact between the protrusion CV and the recess 22B and the contact between the base FD and the support surface 22A are released by the gas supplied from the punch hole 22C. It is separated from the support member 22. When the holding plate 62 is brought into contact with the protrusion holding body CB, the cooling means 70 drives the cooling device 71 to cool the plastic material PM, thereby shrinking the plastic material PM and removing the protrusion CV from the recess 22B. It may be easy to pull out. Further, if the cooling means 70 cools the plastic material PM while the separating means 60 pressurizes the plastic material PM with the holding plate 62, the adhesion between the plastic material PM and the support sheet BS can be improved. After that, the separation means 60 drives the articulated robot 61, and as shown in FIG. 1 (D), the protrusion holding body CB is immersed in the water WT. As a result, the polyethylene glycol PG contained in the plastic material PM is leached into the water WT, and as shown in the enlarged view of FIG. 1 (D), a hole HL is formed in the portion where the polyethylene glycol PG was located and a cavity is formed. The plastic material PM becomes a porous body. After that, the separation means 60 drives the articulated robot 61, conveys the protrusion holding body CB on which the hole HL is formed to a next step (not shown), stops driving the decompression means (not shown), and holds the protrusion holding body CB. The plate 62 is separated, the separated holding plate 62 is returned to the initial position, and the same operation as described above is repeated thereafter.

According to the above embodiment, gas is supplied to the punched hole 22C to release the adhesion between the protrusion holding body CB and the support member 22, so that the support member 22 and the protrusion holding body CB are smoothly separated from each other. Can be done.

The means and processes in the present invention are not limited as long as they can perform the operations, functions or processes described for the means and processes, much less the constituents of the mere embodiment shown in the above-described embodiment. It is not limited to the process at all. For example, the pressing step may be any step as long as the base material is pressed in the direction toward the support surface to fill the recesses with the plastic material, and the protrusions are formed from the plastic material to form the protrusion holder. , There is no limitation as long as it is within the technical scope in light of the common technical knowledge at the time of filing (the same applies to other means and processes).

The material transporting means 10 may be configured to share the articulated robot 61 with the separating means 60 and transport the base material BM without adopting the articulated robot 11, or may be configured to transport the base material BM in place of or in combination with the holding plate 12. A suction pad or the like may be adopted, or it may or may not be provided in the protrusion holding body manufacturing apparatus EA of the present invention. The BM may be transported.

The material supporting means 20 may not have the step portion 21A on the base 21, or may be provided with a decompression means such as a decompression pump or a vacuum ejector for holding the support member 22 or a support member holding means such as a chuck motor. The communication port 92 may be formed inside the support member 22 without the base 21 and may be composed of only the support member 22.
The support member 22 may be made of any material such as metal, resin, silicone material, rubber material, wood, paper, pottery, etc., the number of recesses 22B may be one or more, and the protrusion holding body CB may be formed. In order to facilitate separation from the support member 22, a peelable improving member such as fluorine or silicone may be coated, coated, or laminated on the support surface 22A or the recess 22B, or the support surface may be laminated. A punching hole 22C that can be pulled out only in 22A may be formed, or a punching hole 22C that can be pulled out only in the recess 22B may be formed. In the support member 22 in which one or more recesses 22B are formed, the support surface 22A Only one or more holes 22C may be formed through the holes 22C, and in 22 where one or more recesses 22B are formed, only one or more holes 22C may be formed through the one recess 22B. In the support member 22 in which one or a plurality of recesses 22B are formed, punch holes 22C may be formed in all the recesses 22B, or punch holes 22C may be formed in some of the recesses 22B. The punching hole 22C may be formed in the deepest portion of the recess 22B as in the above embodiment, or the punching hole 22C may be formed in a position other than the deepest portion of the recess 22B.

The pressing means 30 moves the support member 22 without moving the pressing member 32 or while moving the pressing member 32, and presses the base material BM in the direction toward the support surface 22A to form a protrusion CV. The pressing member 32 may or may not be translucent, and the articulated robot 11 and the holding plate 12 may be combined with the material transporting means 10 without adopting the linear motion motor 31 and the pressing member 32. By sharing or sharing the articulated robot 61 and the holding plate 62 with the separating means 60, the base material BM is pressed in the direction toward the support surface 22A via the holding plate 12 and the holding plate 62, and the protrusion CV. The pressing member 32 may be formed by sharing the articulated robot 11 with the material transporting means 10 or sharing the articulated robot 61 with the separating means 60 without adopting the linear motion motor 31. The base material BM may be pressed in the direction toward the support surface 22A to form the protrusion CV.

The heating means 40 may be arranged outside the base 21, may be arranged inside the support member 22 or inside the pressing member 32, or may heat the plastic material PM before being pressed by the pressing means 30. The plastic material PM may be heated during the pressing by the pressing means 30, the plastic material PM may be heated after the pressing by the pressing means 30, or the protrusion holder of the present invention may be heated. It may or may not be provided in the manufacturing apparatus EA.

The positioning means 50 may move at least one of the support member 22 and the pressing member 32 linearly, curvedly, or rotationally in the XY plane, and for example, the support member 22 may be moved in the X direction (or the Y direction). ), The pressing member 32 may be linearly moved or curved in the Y direction (X direction), or the support member 22 or the pressing member 32 may be linearly moved in a direction other than the X direction or the Y direction. Alternatively, the support member 22 or the pressing member 32 may be moved linearly or curvedly in the XY plane, or the support member 22 or the pressing member 32 may be simply rotated in the XY plane. ..
The detection device 51 may be one body or two or more bodies, the position of the support sheet BS with respect to the support surface 22A may be detected from the side of the pressing member 32, and the base 21 and the support member 22 may be transparent. Alternatively, it may be made of a translucent material and may pass through the base 21 and the support member 22 to detect the position of the support sheet BS with respect to the support surface 22A, or may not be supported by the pressing member 32.
The positioning means 50 may position the plastic material PM with respect to the support surface 22A, may position both the support sheet BS and the plastic material PM with respect to the support surface 22A, or may perform positioning of the protrusion holder of the present invention. It may or may not be provided in the manufacturing apparatus EA.

The separating means 60 may be configured to share the articulated robot 11 with the material transporting means 10 and separate the protrusion holding body CB from the support member 22 without adopting the articulated robot 61, or may hold the peeling tape with the protrusions. The protrusion holding body CB may be attached to the body CB and tension is applied to the peeling tape to separate the protrusion holding body CB from the support member 22. The protrusion holding body CB may be easily separated from the support member 22 by applying vibration to the protrusion holding body CB, the protrusion holding body CB may be centrifugally separated, or the protrusion holding body CB may be immersed in water WT. The protrusion holder CB may be moved or vibrated to facilitate the leaching of polyethylene glycol PG into the water WT, or may or may not be provided in the protrusion holder manufacturing apparatus EA of the present invention. However, if it is not provided, the protrusion holding body CB may be separated from the support member 22 by another device or by hand.

The cooling means 70 may provide a cooling device 71 inside or in the vicinity of the pressing member 32 to cool the plastic material PM in a state where the base material BM is pressed by the pressing member 32, or press the base material BM. The plastic material PM may be cooled without cooling, may be provided outside the holding plate 62, may be provided inside the base 21 or the support member 22, or may be provided inside a liquid such as water or a mixed liquid. , The plastic material PM may be immersed in a cooling medium such as an organic solvent such as ethanol or acetone, or an oil such as mineral oil or chemically synthesized oil to cool the plastic material PM, or the atmosphere or cold air may be used as the plastic material PM. The plastic material PM may be cooled by being exposed to the water, or the water WT may be shared with the leaching means 80 to cool the plastic material PM without adopting the cooling device 71, or the protrusion holding body of the present invention may be used. It may or may not be provided in the manufacturing device EA of.

The leaching means 80 leaches a liquid such as water or a mixed solution, an organic solvent such as ethanol or acetone, or an oil such as mineral oil or chemically synthesized oil, which is contained in the base material BM, as a leaching medium. Anything that can be used may be adopted, or the leaching medium may be moved, circulated, vibrated, and stirred to facilitate leaching of the leaching material into the leaching medium, or the protrusion holder of the present invention. It may or may not be provided in the manufacturing apparatus EA.

As shown in the figure with the number AA, the contact releasing means 90 may arrange the pressurizing means 91 inside the support member 22.
The fluid supplied to the draft hole 22C may be a gas such as a single gas or a composite gas, a liquid such as water or a mixed solution, an organic solvent such as ethanol or acetone, or an oil such as mineral oil or chemically synthesized oil.
The timing of supplying the gas from the punching hole 22C may be the same as when the separating means 60 applies the lifting force to the protrusion holding body CB by the articulated robot 61, or may be before the lifting force is applied, or the lifting force may be applied. It may be after giving.

The base material supply means PS may be a simple stand, a belt conveyor, a self-propelled transport stand, or the like, or may be provided in or provided in the protrusion holding body manufacturing apparatus EA of the present invention. It does not have to be.

The protrusion holding manufacturing device EA has, for example, a fluid atmosphere such as a gas such as a single gas or a composite gas, a liquid such as water or a mixed solution, an organic solvent such as ethanol or acetone, or an oil such as mineral oil or chemically synthesized oil. In the above, the base material BM may be pressed in the direction toward the support surface 22A to form the protrusion CV.

As a transmission member, the support sheet BS includes, for example, cloth, non-woven fabric, resin, mesh material, wood, etc., as well as metal, resin, silicone material, rubber material, wood, paper, pottery, etc., which have through holes, and liquids. Any gas may be used as long as it can permeate at least one of them, and permeates liquids and gases such as metals, resins, silicone materials, rubber materials, wood, paper, and pottery. Impossible materials (those that are not transparent members) may be adopted.

Examples of the plastic material PM include those that are deformed by applying energy such as heat and pressure and do not return to their original shape after that, for example, metal, clay, resin, etc., and in the case of resin, for example, PET, polypropylene, polyethylene, etc. , Polyvinyl chloride, poly (lactide-co-glycolide) copolymer (PLGA), etc., as long as they have plasticity, may be composed of a single component, or may be composed of a plurality of components. It may be composed only of those having plasticity, it may be composed of those having plasticity and those having no plasticity, it may not have thermoplasticity, and it may be leached out. It does not have to contain any material.
The ratio of the plastic material PM to the leachate material may be any ratio other than 5: 5, for example, 8: 2 or 1: 9, and the standard of the ratio thereof is, for example, other than the weight ratio. Any standard such as mass ratio, volume ratio, molar ratio, etc. may be used.
The leaching material may be any material such as sodium chloride, potassium nitrate, alum, polyvinyl alcohol, etc., as long as it leaches into the leaching medium.
The base material BM may be composed of only the plastic material PM without the support sheet BS, or may be laminated with other materials in addition to the support sheet BS and the plastic material PM, and the amount of the plastic material PM may be laminated. May be the same amount as the capacity of the recess 22B, or may be equal to or larger than the capacity of the recess 22B.
The height of the protrusion CV may be 100 nm to 3 mm, 100 nm or less, or 3 mm or more. In particular, when used as a so-called microneedle, the height of the protrusion CV may be 100 μm to 1.5 mm.
The tip of the protrusion CV may be sharp, blunt, rounded, arrowhead-shaped, or bifurcated or bifurcated or bifurcated.
The shape of the protrusion CV may be a cone, a pyramid, a cylinder, a prism, or a combination thereof.

As shown in FIG. 1 (E), the protrusion holding body CB may be one in which only the protrusion CV is formed from the plastic material PM and the protrusion CV is directly supported by the support sheet BS, or FIG. 1 (F). ), The protrusion CV and the base FD may be formed from the plastic material PM, and the base FD may be embedded (permeated) in the support sheet BS, or may be shown in FIG. 1 (G). As described above, the protrusion CV and the base FD may be formed from the plastic material PM and may not be supported by the support sheet BS.

The drive device in the above embodiment is an electric device such as a rotary motor, a linear motor, a linear motor, a single-axis robot, an articulated robot having two-axis or three-axis or more joints, an air cylinder, a hydraulic cylinder, and a rodless. Actuators such as cylinders and rotary cylinders can be adopted, and those in which they are directly or indirectly combined can also be adopted.
In the above embodiment, when a pressing means such as a pressing roller or a pressing head or a pressing member for pressing a pressed object is adopted, a roller, a round bar, or a roller, a round bar, may be used in place of or in combination with those exemplified above. In addition to the blade material and brush-like member, a material that is sprayed with a gas such as air or gas may be used, or a material to be pressed may be made of a deformable member such as rubber, resin, or sponge. It may be composed of a non-deformable member such as metal or resin, or when a member that supports (holds) a supported member (held member) such as a supporting (holding) means or a supporting (holding) member is adopted. , Gripping means such as mechanical chucks and chuck cylinders, Coulomb force, adhesive (adhesive sheet, adhesive tape), adhesive (adhesive sheet, adhesive tape), magnetic force, Bernoulli suction, suction suction, drive equipment, etc. A structure that supports (holds) may be adopted.

EA ... Protrusion holding body manufacturing equipment 20 ... Material support means 22 ... Support member 22A ... Support surface 22B ... Recessed portion 22C ... Drilling hole 30 ... Pressing means 80 ... Leaching means 90 ... Adhesion release means BM ... Base material CB ... Protrusion holding body CV ... Protrusion PG ... Polyethylene glycol (leaching material)
PM ... Plastic material WT ... Water (leaching medium)

Claims (3)

A method for manufacturing microneedles having protrusions formed on a support sheet.
A base material preparation step of preparing a base material in which a plastic material is laminated on one surface of the support sheet, and
A material support step of supporting a base material containing a plastic material with a support member having a support surface in which a recess corresponding to the protrusion is formed.
A pressing step of pressing the base material in the direction toward the support surface to fill the recesses with the plastic material, forming the protrusions from the plastic material to form the microneedles , is carried out.
The support member is formed with a hole for exiting at least one of the support surface and the recess.
A method for manufacturing a microneedle , wherein a fluid is supplied to the punched hole in a subsequent stage of the pressing step to perform a contact releasing step of releasing the adhesion between the microneedle and the support member. The method for manufacturing a microneedle according to claim 1, wherein the support sheet is made of a permeable member having a permeability capable of transmitting at least one of a liquid and a gas. A microneedle manufacturing device with protrusions formed on the support sheet.
A support member having a support surface on which a recess corresponding to the protrusion is formed, and a material support means for supporting the base material containing a plastic material.
It is provided with a pressing means for pressing the base material in a direction toward the support surface to fill the recesses with the plastic material, and forming the protrusions from the plastic material to form the microneedles.
In the base material, the plastic material is laminated on one surface of the support sheet.
The support member is formed with a hole for exiting at least one of the support surface and the recess.
The fluid is supplied to the vent hole, the manufacturing apparatus of the microneedles, characterized in that it comprises a contact releasing means for releasing the close contact between the support member and the microneedle.

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