Microimplement and manufacturing method of microimplement

By irradiating maltose fine needles in micro-implements with plasma light to strengthen their surface and refine maltose aggregates, the challenges of moisture absorption and reduced efficacy are addressed, resulting in sharper needles and faster drug penetration.

JP2025088034AActive Publication Date: 2025-06-11MICRO COMPLEX LLC
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Patent Information

Application Number
JP2023202457
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-11-30
Publication Date
2025-06-11
Estimated Expiration
2043-11-30

AI Technical Summary

Technical Problem

The fine needles of micro-implements made of maltose tend to absorb moisture, leading to a loss of sharpness and increased pain during skin penetration, as well as reduced efficacy in drug delivery.

Method used

A method for manufacturing micro-implements involving the irradiation of maltose fine needles with plasma light to strengthen their surface and refine maltose aggregates, thereby maintaining sharpness and enhancing penetration speed.

Benefits of technology

The plasma treatment effectively prevents moisture absorption, maintains the sharpness of the fine needles, and accelerates drug penetration into the body, improving both patient comfort and drug delivery efficiency.

✦ Generated by Eureka AI based on patent content.

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Abstract

To suppress collapse of a distal end shape of a fine needle of a microimplement.SOLUTION: A manufacturing method of a microimplement according to the present embodiment is a manufacturing method of a microimplement including one or more fine needles formed of maltose in which a drug is mixed, and a base plate mounted with the fine needles. The manufacturing method of the microimplement according to the present embodiment includes a step of reinforcing surfaces of the fine needles by irradiating the fine needles with plasma light.SELECTED DRAWING: Figure 8
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Description

Technical Field

[0001] Embodiments of the present invention relate to a micro-implement and a method for manufacturing the micro-implement.

Background Art

[0002] A micro-implement is a medical device having fine needles formed of a biological substance. The fine needles are formed of maltose mixed with a drug. The fine needles are about 0.1 mm thick and about 1 mm long. By pressing the micro-implement against the skin, the fine needles are inserted into the skin. The fine needles formed of maltose inserted into the skin are dissolved by moisture and penetrate into the body together with the drug mixed in the maltose. By using a micro-implement instead of a metal micro-needle or a plastic micro-needle, medical waste can be reduced, which is an environmental measure.

[0003] The fine needles of the micro-implement are often formed in a conical shape with a sharp tip in order to reduce pain when inserted into the skin. However, since the fine needles of the micro-implement are formed of maltose, the fine needles easily absorb moisture in the air. When the maltose fine needles absorb moisture in the air, the sharp shape of the tip of the fine needles may be lost, and the tip may become rounded. When the tip of the fine needles becomes rounded, it is frequent that the pain given to the patient becomes stronger when the micro-implement is pressed against the skin. Also, the drug cannot be administered to the assumed depth under the skin.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] An object of the present invention is to suppress breakage of the tip shape of the fine needle of a micro-imprint. Another object of the present invention is to shorten the time for maltose forming the fine needle to penetrate into the body.

Means for Solving the Problems

[0006] To solve the above problems, a method for manufacturing a micro-imprint according to the present embodiment is a method for manufacturing a micro-imprint including one or more fine needles formed of maltose mixed with a drug and a substrate on which the fine needles are mounted. The method for manufacturing a micro-imprint according to the present embodiment includes a step of strengthening the surface of the fine needles by irradiating the fine needles with plasma light.

[0007] Also, a method for manufacturing a micro-imprint according to the present embodiment is a method for manufacturing a micro-imprint including one or more fine needles formed of maltose mixed with a drug and a substrate on which the fine needles are mounted. The method for manufacturing a micro-imprint according to the present embodiment includes a step of refining aggregates of maltose forming the fine needles by irradiating the fine needles with plasma light.

Brief Description of the Drawings

[0008]

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BEST MODE FOR CARRYING OUT THE INVENTION

[0009] Hereinafter, this embodiment will be described with reference to the drawings. For the description, an XYZ coordinate system composed of an X-axis, a Y-axis, and a Z-axis that are orthogonal to each other will be used as appropriate.

[0010] (Embodiment 1) <Plasma generator> First, the plasma generator used in this embodiment will be described. FIG. 1 is a perspective view of a plasma generator 1 according to the embodiment. The plasma generator 1 includes a plasma generation unit 10 and a high-voltage power supply 30. The plasma generation unit 10 includes a cylindrical case 20 and a first electrode 11 housed in the case 20.

[0011] FIG. 2 is a perspective view showing the plasma generation unit 10 with the case 20 omitted. FIG. 3 is a cross-sectional view showing the AA cross-section of FIG. 1. As shown in FIGS. 2 and 3, the plasma generation unit 10 has a first electrode 11, a second electrode 15, a first magnet 17, eight second magnets 18, a metal member 19, and a case 20. In FIG. 2, the description of the second magnet 18 is omitted.

[0012] As shown in FIG. 3, the case 20 has a case body 21 and a cap 22. The case body 21 is a casing with its upper end closed and its lower end open. An opening 21a penetrating in the Z-axis direction is formed at the center of the upper surface (+Z side surface) of the case body 21. The case body 21 is made of, for example, resin, has a thickness of about 4 mm, a dimension in the Z-axis direction of about 60 mm, and an inner diameter of about 40 mm. Also, the inner diameter of the opening 21a is about 5 mm.

[0013] The cap 22 is an annular member with an opening 22a formed at its central portion. The cap 22 is shaped so that its outer diameter is equal to the outer diameter of the case body 21, and is fixed to the -Z side end of the case body 21. The cap 22 is made of, for example, resin.

[0014] As shown in FIG. 3, the first electrode 11 is a member having two parts, a first discharge part 11a and a conductive part 11b, with its longitudinal direction being the Z-axis direction. The conductive part 11b consists of an M5-sized bolt with a male screw part formed at its lower end. The first discharge part 11a is a member with a diameter of 1 mm and a lower end with a length of about 20 mm that is sharp. The first discharge part 11a is integrated with the conductive part 11b by welding its upper end to the lower end of the conductive part 11b. The first discharge part 11a and the conductive part 11b constituting the first electrode 11 are made of materials such as iron and stainless steel.

[0015] The first magnet 17 is a circular plate-shaped member. A through hole 17a penetrating in the Z-axis direction is formed at the center of the first magnet 17. The first magnet 17 is a magnet with a strong magnetic force such as a neodymium magnet, for example. The first magnet 17 has a thickness of about 5 mm and an outer diameter of about 30 mm. Also, the inner diameter of the through hole 17a is about 5 mm. The first magnet 17 is magnetized such that the upper surface side (+Z side surface) is the S pole and the lower surface side (-Z side surface) is the N pole.

[0016] As shown in FIG. 3, the first electrode 11 configured as described above is inserted into the opening 21a from above the case body 21 via the washer 12. With the first electrode 11 protruding into the case body 21 inserted into the through hole 17a of the first magnet 17, the washer 13 and the nut 14 are fitted onto the conductive portion 11b, thereby integrating the case body 21, the first electrode 11, and the first magnet 17.

[0017] As shown in FIGS. 2 and 3, the second electrode 15 has a second discharge portion 15a and a conductive portion 15b. The conductive portion 15b is a mesh made of metal. The conductive portion 15b can be formed, for example, by cutting out a circular metal mesh. The diameter of the conductive portion 15b is slightly larger than the inner diameter of the case body 21 and is about 45 mm. The arrangement pitch d1 of the metal wires constituting the conductive portion 15b is about 5 mm. Also, the outer diameter of the metal wire is about 0.2 mm. The second discharge portion 15a is welded to the center of the conductive portion 15b.

[0018] The second discharge portion 15a is a member with a diameter of 1 mm and an upper end portion with a length of about 8 mm that is sharp. The second discharge portion 15a is integrated with the conductive portion 15b by welding its lower end to the center portion of the conductive portion 15b. The second discharge portion 15a and the conductive portion 15b constituting the second electrode 15 are made of materials such as iron or stainless steel.

[0019] The second electrode 15 configured as described above is assembled to the case 20 by sandwiching the outer edge portion of the conductive portion 15b between the case body 21 and the cap 22. In this state, the first discharge portion 11a of the first electrode 11 and the second discharge portion 15a of the second electrode 15 are arranged on a straight line S parallel to the Z-axis as shown in FIG. 3. Further, a discharge gap is formed by the tip of the first discharge portion 11a and the tip of the second discharge portion 15a facing each other with a predetermined gap therebetween.

[0020] The metal member 19 is a cylindrical member. The metal member 19 is formed by bending a metal plate with a thickness of 1 mm along the inner peripheral surface of the case body 21. The height (dimension in the Z-axis direction) of the metal member 19 is about 10 mm, and the outer diameter is substantially equal to the inner diameter of the case body 21. The metal member 19 is attached to the case body 21, for example, by adhering the outer peripheral surface to the inner peripheral surface of the case body 21. The metal member 19 is made of a metal such as iron to which a magnet can be attracted.

[0021] Each of the eight second magnets 18 is a magnet with a strong magnetic force such as a neodymium magnet, for example. Each of the second magnets 18 is shaped into a circular plate with a diameter of about 4 mm. Each of the second magnets 18 is magnetized so that one side surface is the S pole and the other side surface is the N pole. Then, each of the second magnets 18 is attached to the metal member 19 by adhering the surface where the N pole appears to the metal member 19. Each of the second magnets 18 is arranged at equal intervals along the inner peripheral surface of the metal member 19 with the straight line S as the center. Further, each of the second magnets 18 is arranged such that adjacent second magnets are offset vertically. As shown in FIG. 4, each of the second magnets 18 is arranged such that the surfaces where the S poles appear face each other.

[0022] In the plasma generator 1, as shown in FIGS. 2 and 3, the metal member 19 is arranged below the discharge gap between the tip of the first discharge portion 11a and the tip of the second discharge portion 15a. Therefore, the plurality of second magnets 18 are arranged so as to surround the second discharge portion 15a.

[0023] As shown in FIG. 1, the high-voltage power supply 30 is fixed to the case body 21. The high-voltage power supply 30 is, for example, a power supply including a DC / DC converter. The high-voltage power supply 30 is connected to, for example, a DC power supply 100 that converts power from a commercial power supply into DC power. Then, the high-voltage power supply 30 boosts the output voltage output from the DC power supply 100 and outputs it to the plasma generation unit 10. As the DC power supply 100, it is conceivable to use one having an output voltage of about 3V to 5V.

[0024] FIG. 5 is a diagram showing the electrical wiring of the plasma generation device 1. As shown in FIG. 5, for the high-voltage power supply 30, the negative electrode is connected to the first electrode 11, and the positive electrode is connected to the second electrode 15. The high-voltage power supply 30 applies a DC voltage of 50,000V to 1,000,000V to the first electrode 11 and the second electrode 15. As a result, an arc discharge occurs in the discharge gap between the first discharge part 11a and the second discharge part 15a. The output voltage of the high-voltage power supply 30 is adjusted according to conditions such as the distance between the first discharge part 11a and the second discharge part 15a, the shape of the tips of the first discharge part 11a and the second discharge part 15a, the atmospheric pressure, and the humidity. Here, for example, the output voltage of the high-voltage power supply 30 is adjusted to about 400,000V.

[0025] Next, the operation of the plasma generation device 1 will be described with reference to FIG. 6. The metal member 19 is magnetized by the second magnet 18. Specifically, since the N pole of the second magnet 18 is in magnetic contact with the metal member 19, the inner peripheral surface of the metal member 19 that contacts the N pole of the second magnet 18 is magnetized to the S pole.

[0026] As shown by the arrow in FIG. 6, inside the case body 21, a magnetic field is formed from the N pole of the first magnet 17 toward the S pole of the second magnet 18 and the inner peripheral surface of the metal member 19. Since the second magnet 18 and the metal member 19 are located on the -Z side of the tip of the first discharge part 11a on the -Z side, a magnetic field in the direction (-Z direction) toward the opening 22a is formed in the vicinity of the first discharge part 11a and the second discharge part 15a. In the opening 22a and its vicinity, part of the magnetic field is formed toward the second magnet 18 and the metal member 19 side, but most of the magnetic field is formed from the second discharge part 15a toward the opening 22a.

[0027] When a DC voltage is output from the DC power supply 100, the high-voltage power supply 30 outputs a DC voltage of approximately 400,000 V. As a result, a DC voltage of approximately 400,000 V is applied between the first electrode 11 and the second electrode 15. Then, an arc is generated between the first discharge part 11a and the second discharge part 15a. When the arc is generated, a part of the molecules constituting the atmosphere around the first discharge part 11a and the second discharge part 15a is separated into positive ions and electrons, and plasma is generated. The amount of plasma generated can be adjusted by the output power of the high-voltage power supply 30, the voltage applied between the first electrode 11 and the second electrode 15, the distance between the first electrode 11 and the second electrode 15, and the like.

[0028] As described above, inside the case body 21, a magnetic field is formed in the direction from the first discharge part 11a and the second discharge part 15a toward the opening 22a. Plasma has the property of moving along the magnetic field lines indicating the direction of the magnetic field. Therefore, most of the generated plasma is irradiated outside the case 20 from the opening 22a without staying inside the case 20. Near the opening 22a of the plasma generator 1, a micro-imprint 200, which is a target for irradiating plasma, is arranged.

[0029] <Micro-imprint> Next, the configuration of the micro-imprint will be described. FIG. 7 is a perspective view showing an example of the micro-imprint 200. The micro-imprint 200 has one or more fine needles 210 formed of maltose mixed with a drug and a substrate 220 on which the fine needles 210 are mounted. The substrate 220 has, for example, a length in the X-axis and Y-axis directions of about 10 mm and a length in the Z-axis direction of about 1 mm. The diameter of the fine needle 210 is about 0.1 mm, and the length is about 1 mm. In FIG. 7, 16 fine needles 210 are shown, but the number of fine needles 210 is not limited. The substrate 220 is formed of, for example, plastics such as polyvinyl alcohol, pullulan, and polyethylene glycol, polysaccharides such as hyaluronic acid, or biogenic substances such as proteins such as collagen.

[0030] <Method for manufacturing a microimplant> Next, a method for manufacturing the microimplant 200 will be described with reference to FIG. 8.

[0031] First, maltose mixed with a drug is produced (step S11). Specifically, a drug is mixed with commercially available powdered maltose. The drug (a pharmaceutical agent or a drug used in cosmetics) mixed in the maltose may be water-soluble. Preferred pharmaceutical agents include, for example, numerous local anesthetics such as lidocaine. Particularly effective are polymeric pharmaceutical agents. For example, bioactive peptides and their derivatives, nucleic acids, oligonucleotides, various antigenic proteins, bacteria, virus fragments, etc. can be mentioned. Also, as the above bioactive peptides and their derivatives, for example, calcitonin, adrenocorticotropic hormone, parathyroid hormone (PTH), hPTH(1→34), EGF, insulin, secretin, luteinizing hormone-releasing hormone, growth hormone, growth hormone-releasing hormone, thyroid-stimulating hormone, prolactin, interferon, interleukin, G-CSF, endothelin, and salts thereof can be mentioned. Examples of antigenic proteins include HBs surface antigen, HBe antigen, etc. Examples of drugs used in the above cosmetics include whitening components such as kojic acid, lucinol, tranexamic acid, vitamin A derivatives, anti-wrinkle components such as retinol, retinoic acid, retinol acetate, retinol palmitate, blood circulation promoting components such as capsaicin, nonylic acid vanillylamide, diet components such as raspberry ketone, evening primrose extract, seaweed extract, antibacterial components such as isopropylmethylphenol, photosensitizer, zinc oxide, and vitamins such as vitamin D2, vitamin D3, vitamin K, etc.

[0032] Next, a fine needle 210 of a predetermined size and shape is manufactured using the maltose produced in step S11 (step S12). Specifically, powdered maltose mixed with a drug is placed in a mold of the fine needle 210. Then, the powdered maltose is heated and melted. The melted maltose in a liquid state is sometimes referred to as liquid-phase maltose. Next, the liquid-phase maltose in the mold of the fine needle 210 is cooled and solidified. The solid-state maltose is sometimes referred to as solidified (solid-phase) maltose.

[0033] FIG. 9 is an image diagram of an aggregate (particle) of maltose forming the fine needle 210. The size of the aggregate of maltose forming the fine needle 210 produced by the process of step S12 is about 0.1 μm to 1.0 μm. The maltose material cooled after melting contains aggregates of a plurality of molecules. The size of the aggregate of maltose forming the fine needle 210 after the process of step S12 is much larger than the size of one maltose molecule.

[0034] Next, a plurality of fine needles 210 are mounted on a substrate 220 to manufacture a micro-imprint 200 as shown in FIG. 7 (step S13).

[0035] Next, a process of refining the aggregates contained in the maltose material is performed (step S14). As shown in FIG. 10, the micro-imprint 200 is disposed near the opening 22a of the plasma generator 1, and for example, plasma light is irradiated from the substrate 220 (back surface) side of the micro-imprint 200.

[0036] Plasma has the characteristic of emitting light at short wavelengths that reach X-rays through arc discharge generating several tens of keV energy. Therefore, the description "irradiated with plasma light" may be less accurate than "irradiated with short-wavelength light reaching X-rays accompanying the generation of plasma". Since plasma has both the collective phenomenon of electrons liberated from ion molecules exciting each other and the wave nature of light with a high frequency, the expression varies depending on which characteristic is focused on. In this specification, expressions such as "irradiated with plasma" or "irradiated with plasma light" will be used.

[0037] By irradiating maltose forming the fine needle 210 with short-wavelength (high-frequency) plasma light having high energy inherent therein, the molecules of maltose forming the fine needle 210 are excited. The excited maltose molecules have a weakened cohesive force with adjacent molecules, making it difficult to form large aggregates in which many molecules aggregate together. Therefore, by irradiating with plasma light, the aggregates of maltose forming the fine needle 210 can be miniaturized. FIG. 11 is an image diagram showing that the aggregates of maltose forming the fine needle 210 are miniaturized by irradiating with plasma light. By irradiating with plasma light, the size of the maltose aggregates shown in FIG. 11 becomes smaller than the size of the aggregates before irradiating with the plasma light shown in FIG. 9. The size of the aggregates of maltose forming the fine needle 210 produced in the process of step S14 can be suppressed to 0.01 μm to 0.1 μm.

[0038] Although the speed at which particles are miniaturized varies depending on the amount of plasma (intensity of plasma light) irradiated from the plasma generation device used, the aggregates of maltose can be miniaturized by irradiating with plasma light. The irradiation time of plasma light is determined by relationships such as the required degree of particle miniaturization, the intensity of the irradiated plasma light, the speed at which the required fine needle 210 dissolves in the body (size of the particles forming maltose), and the irradiation time of plasma light (manufacturing cost). The irradiation time of plasma light in step S14 is, for example, about 15 minutes to 30 minutes.

[0039] Next, a process of strengthening (hardening) the surface of the fine needle 210 is performed by irradiating the fine needle 210 with plasma light (step S15). For example, as shown in FIG. 12, the micro-imprint 200 is disposed near the opening 22a of the plasma generator 1, and plasma light is irradiated from the side of the fine needle 210 (surface) of the micro-imprint 200. By irradiating the plasma light, a polymerized film layer 215 is formed on the surface of the fine needle 210, as shown in FIG. 13.

[0040] Aggregates of maltose on the surface of the fine needle 210 irradiated with plasma light are in a state where moisture is removed and the carbon concentration is high due to the reaction between oxygen in the air and hydrogen constituting maltose. In this state, since the tendency of carbon molecules to bond increases, polymerization (bonding) of maltose molecules occurs. As a result, a polymerized film layer 215 in which maltose molecules are polymerized is formed on the surface of the fine needle 210.

[0041] The speed at which the surface of maltose is strengthened varies depending on the amount of plasma (intensity of plasma light) irradiated from the plasma generator used, but the surface of maltose can be strengthened by irradiating plasma light. The required strength of maltose also varies depending on the storage state (temperature, humidity, etc.) of the micro-imprint 200. The irradiation time of the plasma in step S15 is, for example, about 5 to 15 minutes.

[0042] FIG. 14 is an image diagram showing the tip 211 of the fine needle 210 of the micro-imprint 200 manufactured in the steps up to step S14. Maltose easily absorbs moisture in the air. When maltose absorbs moisture in the air, the sharp shape of the tip of the fine needle 210 may be lost, and the tip may have a rounded shape as shown in FIG. 15. When the tip of the fine needle 210 has a rounded shape, it is frequent that the pain given to the patient becomes stronger when the micro-imprint 200 is pressed against the skin.

[0043] By performing the process of step S15, as shown in FIG. 13, a polymerization coating layer 215 is formed on the surface of the fine needle 210. This is due to the ultraviolet-enhancing property of a kind of resin. By forming the polymerization coating layer 215, it is possible to suppress the maltose forming the fine needle 210 from absorbing the surrounding moisture. Thereby, it is possible to suppress the collapse of the tip shape of the fine needle 210 of the micro-imprint 200.

[0044] As described above, in the micro-imprint 200 according to the embodiment, by irradiating the fine needle 210 with plasma light, the aggregates of maltose forming the surface of the fine needle 210 form the polymerization coating layer 215, and the surface of the fine needle 210 is strengthened. Thereby, it is possible to suppress the collapse of the tip shape of the fine needle 210 of the micro-imprint 200.

[0045] Further, in the micro-imprint 200 according to the embodiment, by irradiating the fine needle 210 with plasma light, due to the high energy of the short-wavelength plasma light, the aggregates of maltose forming the fine needle 210 are excited by the high energy, so that the aggregates of maltose are refined. The smaller the aggregates of maltose are, the easier it is for maltose to penetrate into the body. Therefore, by refining the aggregates of maltose, the time required for the drug contained in maltose to penetrate into the human body can be shortened. Furthermore, when mixing drugs, if there are mixed organic molecules such as amino groups and amine molecules, and biogenic substances such as polysaccharides such as hyaluronic acid and proteins such as collagen, since they are organic molecules containing nitrogen atoms, they are softened by ultraviolet rays, and the aggregates containing these molecules are further refined, and the permeability to the living body is improved, and the drug efficacy is promoted.

[0046] By irradiating with plasma light, the aggregates of maltose inside the fine needle 210 are refined. On the other hand, the maltose on the surface of the fine needle 210 forms the polymerization coating layer 215. Thus, by irradiating with plasma light, it is possible to refine the aggregates of maltose and strengthen the surface of the fine needle 210.

[0047] In addition, since the micro-imprint 200 according to the embodiment forms the fine needle 210 with maltose, even if the fine needle 210 breaks inside the body, it will not result in a medical accident. Also, since the micro-imprint 200 forms the fine needle 210 with maltose, medical waste can be reduced, which is an environmental measure.

[0048] In the above description, the case of irradiating the micro-imprint 200 with plasma light using the small plasma generator 1 shown in FIG. 1 etc. has been described, but the plasma generator to be used does not need to be limited to the plasma generator 1 shown in FIG. 1 etc. For example, a large plasma generator operating with an AC power supply may be used.

[0049] Also, in the above description, in the step of miniaturizing maltose particles in step S14, plasma light is irradiated from the substrate 220 side of the micro-imprint 200, and in the step of strengthening the surface of the fine needle 210 in step S15, plasma light is irradiated from the fine needle 210 side of the micro-imprint 200. However, the step of miniaturizing the aggregate of maltose and the step of strengthening the surface of the fine needle 210 can also be performed in one step. For example, it can also be made to be only the step of irradiating plasma light from the fine needle 210 side of the micro-imprint 200. For example, as shown in FIG. 12, plasma light is irradiated onto the surface (fine needle 210 side) of the micro-imprint 200. In this case, plasma light is irradiated until the polymer coating layer 215 is formed on the surface of the fine needle 210.

[0050] Also, in the above description, the case where the shape of the fine needle 210 is a cone has been described, but the shape of the fine needle 210 does not need to be limited to a cone. For example, the shape of the fine needle 210 may be a quasi-cone such as a triangular pyramid or a square pyramid.

[0051] In the above description, the case where the thickness of the fine needle 210 is about 0.1 mm and the length is about 1 mm has been described. However, it is not necessary to limit the thickness and length of the fine needle 210 to this. The thickness and length of the fine needle 210 can be adjusted in consideration of the depth from the skin surface to be supplied, the amount of drug to be supplied, the degree of pain felt when the micro-implement 200 is pressed against the skin, and the like. For example, when the micro-implement 200 is used for a horse or the like, it is conceivable to use a thick and long fine needle 210.

[0052] (Embodiment 2) FIG. 16 is a diagram extracting one of the fine needles 210 described in FIG. 7. In Embodiment 1, the case where the shape of the fine needle 210 is conical has been described. The fine needle 210 according to Embodiment 2 is shown in FIG. 17. The fine needle 210 of the micro-implement 200 according to Embodiment 2 has a columnar support portion 212 having the same diameter as the tip portion 211 provided between the tip portion 211 and the substrate 220. By changing the mold used in the step S12 shown in FIG. 8, the fine needle 210 having the shape shown in FIG. 17 can be manufactured. By providing the support portion 212, the length from the substrate 220 to the tip of the fine needle 210 can be adjusted. Thereby, the depth from the skin surface to which the drug is supplied by the fine needle 210 can be adjusted.

[0053] (Embodiment 3) The fine needle 210 of the micro-implement 200 according to Embodiment 3 is shown in FIG. 18. The fine needle 210 according to Embodiment 3 has a conical tip portion 211, a support portion 212 described in Embodiment 2, and a columnar pedestal portion 213 having a diameter larger than the diameter of the support portion 212 provided between the support portion 212 and the substrate 220. By changing the mold used in the step S12 shown in FIG. 8, the fine needle 210 having the shape shown in FIG. 18 can be manufactured. By providing the pedestal portion 213, the depth from the skin surface to which the drug is supplied by the fine needle 210 can be adjusted.

[0054] Although some embodiments of the present invention have been described, these embodiments are presented by way of example and are not intended to limit the scope of the invention. These novel embodiments can be implemented in various other forms, and various omissions, replacements, and changes can be made without departing from the gist of the invention. These embodiments and their modifications are included in the scope and gist of the invention, and are included in the invention described in the claims and the equivalent scope thereof.

Explanation of Reference Numerals

[0055] 1…Plasma generation device 10…Plasma generation section 11…First electrode 11a…First discharge section 11b…Conductive section 11f…Disk section 12, 13…Washer 14…Nut 15…Second electrode 15a…Second discharge section 15b…Conductive section 17…First magnet 17a…Through hole 18, 18b…Second magnet 18c…Opening 19…Metal member 20…Case 21…Case body 21a, 22a…Opening 22…Cap 20f…Hole 30…High voltage power supply 100…DC power supply 200…Micro-imprint 210…Fine needle 211…Tip portion 212…Support portion 213…Base portion 215…Polymer film layer 220…Substrate 230…Support portion 240…Base portion

Claims

1. In a method for manufacturing a micro-imprint comprising one or more fine needles formed of maltose mixed with a drug and a substrate on which the fine needles are mounted, the method includes a step of strengthening the surface of the fine needles by irradiating the fine needles with plasma light. A method for manufacturing a micro-imprint.

2. In a method for manufacturing a micro-imprint comprising one or more fine needles formed of maltose mixed with a drug and a substrate on which the fine needles are mounted, the method includes a step of refining aggregates of the maltose forming the fine needles by irradiating the fine needles with plasma light. A method for manufacturing a micro-imprint.

3. A first electrode to which the negative electrode of a DC power supply is applied and a second electrode to which the positive electrode of the DC power supply is applied, which are arranged such that their tips face each other, a first magnet and a second magnet that are arranged spaced apart from each other and form a magnetic field in a direction toward a target around the tips of the first electrode and the second electrode that face each other, and using a plasma generator that irradiates plasma light toward the target, the method includes a step of strengthening the surface of the fine needles of a micro-imprint comprising one or more fine needles formed of maltose mixed with a drug and a substrate on which the fine needles are mounted by irradiating the fine needles with plasma light. A method for manufacturing a micro-imprint.

4. A first electrode to which the negative electrode of a DC power supply is applied and a second electrode to which the positive electrode of the DC power supply is applied, which are arranged such that their tips face each other, a first magnet and a second magnet that are arranged spaced apart from each other and form a magnetic field in a direction toward a target around the tips of the first electrode and the second electrode that face each other, and using a plasma generator that irradiates plasma light toward the target, the method includes a step of refining aggregates of maltose forming the fine needles of a micro-imprint comprising one or more fine needles formed of maltose mixed with a drug and a substrate on which the fine needles are mounted by irradiating the fine needles with plasma light. A method for manufacturing a micro-imprint.

5. In a micro-imprint comprising one or more fine needles formed of maltose mixed with a drug and a substrate on which the fine needles are mounted, A micro-imprint in which a polymer film layer in which aggregates of maltose are polymerized is formed on the surface of the fine needle by irradiating the fine needle with plasma light.

6. In a micro-imprint comprising one or more fine needles formed of maltose mixed with a drug and a substrate on which the fine needles are mounted, A micro-imprint in which the aggregates of maltose forming the fine needles are refined by irradiating the fine needles with plasma light.

7. The size of the aggregates of maltose refined by irradiating with plasma light is 0.01 μm to 0.1 μm. The micro-imprint according to claim 6.

8. The fine needle Has a conical tip, And a columnar support portion having the same diameter as the tip provided between the tip and the substrate on which the fine needle is mounted. The micro-imprint according to claim 5 or 6.

9. The fine needle Has a conical tip, The support portion And a columnar pedestal portion having a total diameter larger than the diameter of the support portion provided between the support portion and the substrate. The micro-imprint according to claim 8.

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