CN113509638A - Micro-needle array with micropores and preparation method thereof - Google Patents
Micro-needle array with micropores and preparation method thereof Download PDFInfo
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- CN113509638A CN113509638A CN202110537857.7A CN202110537857A CN113509638A CN 113509638 A CN113509638 A CN 113509638A CN 202110537857 A CN202110537857 A CN 202110537857A CN 113509638 A CN113509638 A CN 113509638A
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- 238000004519 manufacturing process Methods 0.000 claims abstract description 14
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- 238000005459 micromachining Methods 0.000 claims abstract description 12
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0046—Solid microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
Abstract
The invention discloses a micro-needle array with micropores and a preparation method thereof. The invention adopts methods such as laser etching or MEMS micromachining to respectively process the microneedle grooves and the columnar bulges on the upper die and the lower die to obtain a microneedle and micropore integrated forming die, and then injects a polymer into the die through hot pressing forming to prepare the microneedle array with micropores. The invention can also adopt methods such as the second laser etching method or MEMS micro-machining method to carry out micro-needle groove processing on the upper die, obtain the micro-needle die and then carry out injection molding to prepare the micro-needle array, and then form the micro-needle array with micropores through mechanical opening. The micropores penetrate through the substrate and are arranged on the same substrate with the microneedles in the shapes of cones or pyramids and the like to form a microneedle array structure with micropores, and the micropores can be single-hole penetrated or porous dispersed. The invention makes up the disadvantage of difficult manufacture of the polymer hollow microneedle, integrates the microneedle and the micropore, and greatly improves the dosage, the administration rate and the continuity.
Description
Technical Field
The invention relates to the technical field of cosmetology, in particular to a micro-needle array with micropores on a head part of a cosmetology instrument and a preparation method thereof.
Background
In recent years, microneedles have been emerging as a transdermal technology in the consumer market, and have attracted considerable attention in the fields of medical beauty and the like. The typical drug coating on the skin surface is hindered by the stratum corneum, and the drug is not sufficiently absorbed by the skin. The micro-needle can penetrate through the epidermis layer to generate a large number of micro-channels, so that the effective components of the medicine are supplied to the subcutaneous part. Transdermal administration with microneedles causes little, if any, trauma to the skin, recovers quickly, and is not painful.
Wherein the microneedles may be made of different materials, e.g. silicon microneedles, polymer microneedles, metallic microneedles. The silicon micro-needle is easy to break off and enter a blood circulation system in the process of penetrating into the skin, so that the silicon micro-needle is harmful to a human body, the cost of a metal material is higher, the polymer micro-needle is low in cost and has biocompatibility, the silicon micro-needle can be degraded even if entering the human body, and the silicon micro-needle is harmless to the silicon micro-needle. However, solid microneedles cannot be directly administered by injection, require coating with a drug, and the amount administered depends on the amount of coating, greatly limiting the rate and continuity of administration. Hollow microneedles can solve the above problems and continuously administer drugs in a manner similar to injection, but the hollow microneedles are difficult to fabricate with respect to polymer materials.
Disclosure of Invention
The invention aims to provide a micro-needle array with micropores, which aims at overcoming the defects of the prior art, and effectively solves the difficulty in manufacturing polymer material hollow micro-needles through an array structure that the micro-needles and the micropores are arranged on the same substrate, so that a cosmetic liquid can be continuously and uniformly delivered to skin.
The invention aims to provide a preparation method of a micro-needle array with micropores.
The specific technical scheme for realizing the purpose of the invention is as follows:
a preparation method of a micro-needle array with micropores is characterized by comprising the following steps:
a) concave die for manufacturing flattened substrate
Processing a polymer or metal material by adopting a laser etching or MEMS micro-machining method to prepare a rectangular or round concave die with a flattened side surface, namely a substrate concave die, which is used as an upper die;
b) integrated mold for manufacturing micro-needle and micro-hole through etching
Continuously etching microneedle grooves at equal intervals in the female die of the upper die by using a laser etching or MEMS micromachining method, etching columnar protrusions on the lower die, and staggering the columnar protrusions of the lower die and the microneedle grooves of the upper die after die assembly; etching the upper and lower dies to obtain a microneedle and micropore integrated forming die; the equal interval is 0.05 mm-3 mm; the microneedle groove is conical, pyramidal or polygonal pyramidal in shape; the diameter of the conical tip part is 1-100 mu m, and the diameter of the bottom part is 0.05-1 mm; the columnar bulge is a cylinder or a polygonal body;
c) hot-pressing to form micro-needle array with micropores
Selecting a hot press, respectively installing an upper die and a lower die on an upper die seat and a lower die seat of the hot press, preparing a polymer sheet material, placing the polymer sheet material in the lower die, carrying out hot press molding by the hot press, and removing the die to obtain the micro-needle array with the micropores.
The preparation method of the micro-needle array with the micropores is characterized by comprising the following steps:
a) concave die for manufacturing flattened substrate
Processing a polymer or metal material by adopting a laser etching or MEMS micromachining method to prepare a rectangular or round concave die with a flattened side surface, namely a substrate concave die, which is used as an upper die;
b) etching micro-needle array manufacturing mold
Continuously etching the microneedle grooves at equal intervals in the upper die concave die by using a laser etching or MEMS micromachining method; preparing a microneedle array mould by etching the upper mould; wherein the equal interval is 0.05 mm-3 mm; the microneedle groove is conical, pyramidal or polygonal pyramidal in shape; the diameter of the conical tip part is 1-100 mu m, and the diameter of the bottom part is 0.05-1 mm;
c) injection molding to form microneedle arrays
Selecting a small injection molding machine, preparing polymer granules, placing the polymer granules in a charging barrel, performing injection molding by using the injection molding machine, and removing the mold to obtain the microneedle array;
d) mechanically perforating to obtain micro-needle array with micropores
Etching and forming micropores in the middle of the prepared microneedle array by using a mechanical perforator or laser, wherein the micropores and the microneedles are positioned on the same substrate, and the diameter of each micropore is 0.5-5 mm; obtaining the micro-needle array with the micropores.
The polymer is PMMA, PS, PVA, PCL, PLA, PGA, PLGA, PC or PVP; the metal is titanium, copper, aluminum, nickel, tungsten, stainless steel, titanium alloy, nickel alloy, aluminum alloy or copper alloy.
The micropores and the microneedles are distributed on the same female die substrate, penetrate through the female die substrate and form a microneedle array together with the microneedles, wherein the micropores are in single-hole penetration or porous distribution.
The diameter of the porous distributed holes is 0.05 mm-2 mm, and the diameter of the single-hole penetrated holes is 0.5 mm-5 mm.
A micro-needle array with micropores, which is respectively prepared by the two methods.
The invention adopts methods such as laser etching or MEMS micromachining to respectively process the microneedle grooves and the columnar bulges on the upper die and the lower die to obtain a microneedle and micropore integrated forming die, and then injects a polymer into the die through hot pressing forming to prepare the microneedle array with micropores. The invention can also adopt methods such as the second laser etching method or MEMS micro-machining method to carry out micro-needle groove processing on the upper die, obtain the micro-needle die and then carry out injection molding to prepare the micro-needle array, and then form the micro-needle array with micropores through mechanical opening. The micro-needle array can be used for carrying nutrients on the whole face, and local nutrient delivery can be carried to specific parts of the face according to the micro-needle array, so that the micro-needle array beautifying speed, continuity and dosage are greatly improved, and the practical operation steps are simplified.
Drawings
FIG. 1 is a schematic structural view of a porous square microneedle array according to the present invention;
fig. 2 is a diagram of a porous square microneedle object according to example 1 of the present invention;
FIG. 3 is a schematic structural view of a single-well circular microneedle array according to the present invention;
FIG. 4 is a schematic view of the structure of the porous square upper and lower molds of the present invention.
Detailed Description
The invention is described in detail below with reference to the figures and examples.
Example 1
Preparation of porous Square microneedle array
a) Concave die for manufacturing flattened substrate
The PCL polymer material is processed by a laser to form a base matrix 42 with a flattened side 41, constituting the upper mould 4, as shown in figure 4.
The substrate concave die is square, and the side length of the square is 2 cm.
The height of the substrate concave die is 2 mm.
b) Integrated mold for manufacturing micro-needle and micro-hole through etching
Referring to fig. 4, the selected laser types are: cnc-3020, which were arranged at equal intervals of 1mm to form a square array of 11 × 11 microneedles and 10 × 10 micropores.
Etching a micropore groove 43 on the upper die by using a laser at a corresponding position according to the array requirement to prepare a microneedle; by controlling the laser, the microneedle array can be distributed throughout the array or at specific locations for the array, such as around the perimeter;
meanwhile, the lower die 5 is etched with the columnar projections 51 to prepare micropores, after die assembly, when molten liquid polymer flows through the columnar projections, the columnar projections are isolated to form micropores, so that a microneedle and micropore integrated forming die is prepared, and then a microneedle array with micropores can be obtained through one-step hot press forming.
And ultrasonically cleaning the etched upper die by using acetone and ultrapure water respectively, and then drying the upper die in an oven at the temperature of 80 ℃.
The shape of the microneedle is a triangular cone.
The diameter of the tip of the micro-needle is 12 μm, and the diameter of the bottom of the needle is 0.35 mm.
The pore size is 0.5 mm.
The microneedle is arranged at equal intervals with the interval of 1 mm.
The height of the columnar bulge and the height of the substrate concave die are both 2 mm.
c) Hot pressing to form microneedle arrays
Referring to fig. 4, an AR-1701 hot press is selected, an upper die and a lower die are assembled and respectively mounted on an upper die base and a lower die base of the hot press, polymethyl methacrylate (PMMA) polymer sheet materials are prepared, and the polymer sheet materials are firstly put into a hot air circulation dryer for drying, wherein the drying temperature is as follows: at 85 ℃ for the following time: 3 hours; placing the dried polymer sheet on a lower die, starting a hot press to enable an upper die to be folded towards the lower die, and carrying out hot pressing, wherein the set hot pressing temperature is as follows: 150 ℃; the hot pressing time is set as follows: 10 minutes; the hot pressing pressure is as follows: 100 Mpa; filling the polymer sheet material into the gap between the upper die and the lower die and the micro-needle groove etched on the upper die through deformation and flow of the polymer sheet material; the columnar convex part on the lower die isolates polymer fluid to form micropores; and after hot pressing is finished, cooling by using water, and demolding to obtain the microneedle array 1.
Example 2
Preparation of Single-hole circular microneedle array
a) Concave die for manufacturing flattened substrate
The PMA polymer material is processed with a laser to form a substrate cavity with a flattened side on the upper mold.
The substrate concave die of the upper die is circular, and the diameter of the circle is 2 cm.
The height of the substrate concave die is 2 mm.
b) Etching micro-needle array manufacturing mold
Referring to fig. 3, the selected laser types are: cnc-3020, wherein three rings are arranged from inside to outside in a surrounding way at equal intervals by bisecting the circumference of the circular rail to form circular arrays of 16, 16 and 32 microneedles respectively.
Etching a micropore groove on an upper mould by using a laser at a corresponding position according to the array requirement to prepare a microneedle; by controlling the laser, the microneedle array can be distributed throughout the array or at specific locations for the array, such as around the perimeter;
and ultrasonically cleaning the etched upper die by using acetone and ultrapure water respectively, and then drying the upper die in an oven at the temperature of 80 ℃.
The microneedles are conical in shape.
The diameter of the tip of the micro-needle is 12 μm, and the diameter of the bottom of the needle is 0.35 mm.
c) Injection molding to form microneedle arrays
Referring to fig. 3, a small injection molding machine is selected to prepare polymethyl methacrylate (PMMA) polymer granules, and the polymer granules are first put into a hot air circulation dryer to be dried, wherein the drying temperature is as follows: at 85 ℃ for the following time: 3 hours; placing the dried polymer granules into a charging barrel, and starting an injection molding machine to subject the plastic material to heating, conveying, compacting, shearing, mixing and homogenizing in the charging barrel to convert the material from a glass state to a viscous state so as to meet the injection molding requirement; then the screw rod injects the melt in the storage chamber into the cavity through the nozzle, the mold runner and the pouring gate under the thrust action of the injection oil cylinder; continuously injecting the plastic for filling the volume vacated by the part due to shrinkage; after the pressure preservation is finished, the pouring gate is sealed and frozen, and the product is cooled and shaped for a first time; after the product is cooled for a period of time, the product has certain rigidity and strength; and ejecting the part from the injection mold through an ejector rod of the mold to obtain the microneedle array 3.
d) Mechanically perforating to obtain micro-needle array with micropores
And etching and perforating on the formed circular microneedle array by using a mechanical perforator.
The hole digger is provided with a central drill bit and a toothed ring, and the toothed ring with the outer diameter of 5mm, namely the diameter of a hole, is selected according to the aperture size.
The hole digger is clamped on a drill chuck of a hand-held electric drill or a bench drill.
The center of a hole is determined at the position of the micro-needle array, which needs to be drilled, the center drill of the hole opener is aligned to the center of the hole, the center drill is used for drilling a center hole on the micro-needle array polymer material, and after the toothed ring is contacted with the material, the toothed ring continues to drill downwards, so that a round hole can be drilled on the micro-needle array.
The round hole manufactured on the micro-needle array is surrounded by the micro-needle and is of a hollow flat cylindrical structure, the round hole is a hollow inner ring, and the multi-micro-needle head is an outer ring, so that the multi-needle single-hole round micro-needle array is formed.
Referring to fig. 2, when in use, the square microneedle array with the micropores can be used as a microneedle head of the beauty instrument through bonding and packaging, when the beauty instrument is started, the microneedle array with the micropores on the head is vibrated, so that the microneedles 2 pierce the epidermal layer to generate a large number of micro channels, and meanwhile, the medicinal components in the medicine bag in the beauty instrument flow out of the micropores and are directly, continuously and effectively supplied to the subcutaneous part through the channels opened by the vibration of the microneedles, so that the permeation effect, the permeation rate and the continuity of the medicinal components are improved.
Due to strict design and limitation on the height of the microneedle 2, the needle point of the microneedle 2 cannot pierce the dermis layer in the process of piercing the skin, the integrity of the skin structure cannot be damaged, the skin can be quickly and naturally healed, the pain feeling cannot be generated, and the permeability of nutrients can be improved.
Therefore, painless micro-needle cosmetic surgery can be realized, and the micro-needle array with the micropores can directly, continuously and effectively deliver the medicine through the micropores while the micro-needles puncture the epidermal layer to open the channel, so that the beauty instrument can generate the optimal cosmetic absorption effect on the skin.
Claims (5)
1. A method for preparing a microneedle array with micropores is characterized by comprising the following steps:
a) concave die for manufacturing flattened substrate
Processing a polymer or metal material by adopting a laser etching or MEMS micro-machining method to prepare a rectangular or round concave die with a flattened side surface, namely a substrate concave die, which is used as an upper die;
b) integrated mold for manufacturing micro-needle and micro-hole through etching
Continuously etching microneedle grooves at equal intervals in the female die of the upper die by using a laser etching or MEMS micromachining method, etching columnar protrusions on the lower die, and staggering the columnar protrusions of the lower die and the microneedle grooves of the upper die after die assembly; etching the upper and lower dies to obtain a microneedle and micropore integrated forming die; the equal interval is 0.05 mm-3 mm; the microneedle groove is conical, pyramidal or polygonal pyramidal in shape; the diameter of the conical tip part is 1-100 mu m, and the diameter of the bottom part is 0.05-1 mm; the columnar bulge is a cylinder or a polygonal body;
c) hot-pressing to form micro-needle array with micropores
Selecting a hot press, respectively installing an upper die and a lower die on an upper die seat and a lower die seat of the hot press, preparing a polymer sheet material, placing the polymer sheet material in the lower die, carrying out hot press molding by the hot press, and removing the die to obtain the micro-needle array with the micropores; wherein:
the polymer is PMMA, PS, PVA, PCL, PLA, PGA, PLGA, PC or PVP; the metal is titanium, copper, aluminum, nickel, tungsten, stainless steel, titanium alloy, nickel alloy, aluminum alloy or copper alloy.
2. A method for preparing a microneedle array with micropores is characterized by comprising the following steps:
a) concave die for manufacturing flattened substrate
Processing a polymer or metal material by adopting a laser etching or MEMS micromachining method to prepare a rectangular or round concave die with a flattened side surface, namely a substrate concave die, which is used as an upper die;
b) etching micro-needle array manufacturing mold
Continuously etching the microneedle grooves at equal intervals in the upper die concave die by using a laser etching or MEMS micromachining method; preparing a microneedle array mould by etching the upper mould; wherein the equal interval is 0.05 mm-3 mm; the microneedle groove is conical, pyramidal or polygonal pyramidal in shape; the diameter of the conical tip part is 1-100 mu m, and the diameter of the bottom part is 0.05-1 mm;
c) injection molding to form microneedle arrays
Selecting a small injection molding machine, preparing polymer granules, placing the polymer granules in a charging barrel, performing injection molding by using the injection molding machine, and removing the mold to obtain the microneedle array;
d) mechanically perforating to obtain micro-needle array with micropores
Etching and forming micropores in the middle of the prepared microneedle array by using a mechanical perforator or laser, wherein the micropores and the microneedles are positioned on the same substrate, and the diameter of each micropore is 0.5-5 mm; obtaining the micro-needle array with the micropores; wherein:
the polymer is PMMA, PS, PCL, PVA, PLA, PGA, PLGA, PC or PVP; the metal is titanium, copper, aluminum, nickel, tungsten, stainless steel, titanium alloy, nickel alloy, aluminum alloy or copper alloy.
3. The method for preparing a microneedle array according to claim 1 or 2, wherein the micro-holes and the microneedles are distributed on the same concave substrate, and the micro-holes penetrate through the concave substrate to form the microneedle array together with the microneedles, wherein the micro-holes are single-hole penetrating or multi-hole distributed.
4. A method for preparing a micro-needle array having micro-holes according to claim 3, wherein the diameter of the holes of the porous distribution is 0.05mm to 2mm, and the diameter of the holes penetrated by the single hole is 0.5mm to 5 mm.
5. A micro-needle array with micro-holes manufactured by the method of claim 1 and 2, respectively.
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| CN202110537857.7A CN113509638A (en) | 2021-05-18 | 2021-05-18 | Micro-needle array with micropores and preparation method thereof |
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| CN202110537857.7A CN113509638A (en) | 2021-05-18 | 2021-05-18 | Micro-needle array with micropores and preparation method thereof |
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| CN113509638A true CN113509638A (en) | 2021-10-19 |
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Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
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