CN101912663B - Empty micropin array chip, percutaneous dosing paster, device and manufacture method thereof - Google Patents
Empty micropin array chip, percutaneous dosing paster, device and manufacture method thereof Download PDFInfo
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- CN101912663B CN101912663B CN 201010256734 CN201010256734A CN101912663B CN 101912663 B CN101912663 B CN 101912663B CN 201010256734 CN201010256734 CN 201010256734 CN 201010256734 A CN201010256734 A CN 201010256734A CN 101912663 B CN101912663 B CN 101912663B
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Images
Classifications
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- 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
- A61M2037/0053—Methods for producing microneedles
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
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Abstract
The invention discloses an empty micropin array chip which comprises a substrate and an empty micropin, wherein the empty micropin comprises a pin head and a pin rod, the empty micropin is fixed on the substrate through the pin rod and is inclined to the substrate at a certain angle, the pin head is provided with an oval-shaped annular plane, one end of the pin head is a pinpoint, one part of the oval-shaped annular plane is embedded into the substrate, the pin rod is an empty circular pipe which is embedded into the substrate or is penetrated through the substrate, the bottom of the pin rod is parallel with the lower surface of the substrate or is convex or concave, and the empty micropin penetrates through the two sides of the substrate to be formed into the hole-shaped micropin or the bottom of the pin rod is sealed to be formed into a blind hole type micropin. The empty micropin array chip is firm in structure, sharp in pinpoint, convenient in puncture, low in cost, high in yield, and suitable for manufacture in bulk. The micropin in the array has good consistency, is free of pain feel and blooding when in use, and is safe and reliable since the minimally-invasive skin can fast heal after in use.
Description
Technical field
The present invention relates to medicine and medical treatment and beauty treatment instrument technical field, particularly relate to a kind of empty micropin array chip and based on percutaneous dosing paster, device and the preparation method of this kind chip.
Background technology
The skin of human body has three-layer weave: horny layer, active epidermal area and skin corium.Outermost cuticle thickness is about the 30-50 micron, is made up of the horn cell of densification, and its permeability to most medicines is very low, is the major obstacle that these medicine percutaneous are carried; Be epidermal area below the horny layer, thickness is about the 50-100 micron, contains competent cell and very a spot of nervous tissue, but does not have blood vessel; Be skin corium below the epidermal area, it is the key component of skin, contains a large amount of living cells, nervous tissue and vascular tissue.The syringe needle external diameter that the tradition hypodermic injection uses is generally the 0.4-3.4 millimeter, the syringe needle transdermal must be deep in the muscle during injection, will touch blood vessel undoubtedly and damage a large amount of nervous tissues, therefore except meeting was hemorrhage, the patient tended to experience comparatively violent pain.
Transdermal delivery system claims Transcutaneous Therapeutic System again, refers to that medicine enters a class preparation that body circulation produce drug effect by skin through the blood capillary absorption with certain speed.Compare with traditional administering mode, percutaneous dosing has many advantages: can produce lasting, constant and controlled blood drug level, make because the body intracellular metabolic rapidly and very short pharmaceutically active of half-life obviously improves, avoided the first pass effect of liver and the interference of gastrointestinal factors, toxic and side effects has been dropped to minimum; Have painless, noinvasive or invasive, but patient's self-medication, and also interruption of the administration at any time is easy to use.Though percutaneous dosing is very tempting, to work as the medicine that advances into percutaneous dosing market, the world and have only about 20 kinds, this mainly is because the barrier effect of keratodermatitis causes the transdermal penetration speed of most medicines too low, can not satisfy the needs for the treatment of.Medicine that now can percutaneous dosing is subjected to many restrictions, for example molecular weight less than 500D, fat-solubility, fusing point less than 150 ℃, therapeutic dose less than 20 milligrams/day etc., macromolecule and polar medicine are difficult to realize passive percutaneous dosing.
In order to increase the permeability of skin, people have adopted several different methods such as chemical penetrating agent, iontherapy and electroporation method.All there is in various degree limitation in these methods to the medicine that transmits, and some may also can cause bigger toxic and side effects.1998, U.S. Prausnitz professor seminar is used for the percutaneous dosing field with the miniature solid silicon pin array of MEMS (MEMS) technology preparation first, find that it can improve 4 orders of magnitude with the percutaneous permeation of biopolymer model drug calcein, has from then on started the tide of microneedle transdermal delivery research in the world.Adopt the MEMS technology can produce short and small and sharp microneedle array low-costly and in high volume, by pressing the mode of executing pin can moment obviously improves medicine in the duct that keratodermatitis and epidermal area produce a large amount of micron dimension sizes permeability, should be applicable to any medicine that comprises biopharmaceutical macromolecular drug in theory and be not subjected to the restriction of molecular weight size, medicine polarity, fusing point etc.Because the micropin medicine-feeding part does not touch nervous tissue and blood vessel at body surface, therefore can not produce pain and bleeding; Adopt the micropin administration not need the professional to operate, flexible and convenient to use, interruption of the administration at any time is so accepted by the patient easilier.
With percutaneous dosing in like manner because cuticular barrier effect, adopt general traditional method to use cosmetics and skincare product, most active nutrients wherein are difficult to enter active epidermal area and skin corium, so cosmetic result is not remarkable.If have the microneedle array of cosmetics and skincare product to thrust skin surface applied, or microneedle array thrusts and removes repaste behind the skin and apply cosmetics and skincare product, all can obviously improve active nutrient and pass through the penetrating power that horny layer enters epidermal area and skin corium cell, thereby significantly improve the looks improving and the skin nourishing effect.
Micropin has two types of solid needle and hollow needles.In use, adopt following two kinds of administering modes usually for the solid microneedles array chip: 1) earlier microneedle array is thrust skin and form hole, again medicated patches is applied on therapentic part; 2) behind microneedle array surface-coated medicine, thrust skin and continue release.Adopt device that above-mentioned two kinds of medications make especially the latter be called as the microneedle transdermal delivery paster.Normally adopt the form of microinjection to carry medicine for empty micropin, be applicable to liquid and the bigger medicine of therapeutic dose requirement.The requirement microneedle configuration is firm, not easy fracture, little, painless, the Wicresoft of the power of thrusting in the use.
The material of making micropin has polymer, monocrystal silicon and metal etc.The outstanding problem that existing polymer micro needle exists is that the strength of materials is not enough, is difficult for piercing through the horny layer of skin.Hard, the easy brittle failure of monocrystal silicon material, it has bio-compatibility preferably though bibliographical information is arranged, and does not also belong to conventional medical material now, whether can be applicable to that the biological medicine aspect is still waiting further textual criticism.Metal though its safety is unquestionable, adopts traditional precision machining method to be difficult to process low-costly and in high volume solid, hollow metal micro-needle array chip at same metal basal board for the manufacture of acupuncture needle or existing thousand one-hundred-year histories of injection needle.In the prior art, adopt some hollow metal tubes to tilt to penetrate underlay substrate according to certain distribution and form the micro-needle array chip blank, then the metal tube grinding and polishing that stretches out is formed the needle point that syringe needle has elliptic plane, utilize the ductility of metal can further adjust the angle of inclination of syringe needle mechanically at last.The micropin that this mode of employing not hard to imagine is prepared has following feature: the elliptic plane on (1) syringe needle necessarily all is positioned on the underlay substrate surface, and in order to improve the distance that yield rate must increase elliptic plane and substrate surface as far as possible; (2) in order to make the sharp keen needs of needle point increase area or the ovality of elliptic plane as far as possible, at first must make metal tube tilt underlay substrate as far as possible, treat to adjust the angle of inclination again in order to use to behind its grinding and polishing formation elliptic plane.Be subjected to the limited restriction in angle of inclination, adopt this mode to be difficult to produce very sharp keen needle point on the one hand, adjust on the other hand that needle point behind the angle of inclination can exceed the big distance of underlay substrate usually and easily to cause Shi Zhenshi to thrust skin dark excessively.
In addition, the microneedle transdermal delivery paster of researching and developing at present all adopts the solid microneedles array in the needle point drug of topical application.Because the needle point of solid microneedles is small, sharp-pointed and smooth surface, the drug of topical application amount on it will be very limited undoubtedly; In the horny layer process of executing the densification of pin transdermal appearance, these medicines also have quilt to be come off in external risk.Therefore, have the drawback that there is dosage weak point of few, effective treatment time in the solid microneedles percutaneous dosing paster, is unsuitable for liquid state and ointments medicine now.
Summary of the invention
(1) technical problem that will solve
The technical problem to be solved in the present invention is controllability, the sharpness that improves needle point, the manufacturing cost that reduces micro-needle array chip that strengthens micropin length or height, the safety that improves yield rate and use.
Another technical problem that the present invention will solve is the drug storage amount that increases the microneedle array percutaneous dosing paster, reduces and executes the probability that pin process Chinese medicine breaks away from, and enlarges selecting the medicine scope, improving effective treatment time and cost performance of transdermal patch.
Another technical problem that the present invention will solve is the administration device that designs according to actual needs based on micro-needle array chip, strengthens motility, convenience and the safety used, improves drug effect or looks improving and the skin nourishing effect.
(2) technical scheme
For solving above-mentioned first technical problem, a kind of empty micropin array chip is provided, comprise substrate and empty micropin, described empty micropin comprises syringe needle and shank, described syringe needle is the part that described empty micropin exposes substrate top surface, and described empty micropin is fixed on the described substrate by described shank and to described substrate tilting set angle;
Described syringe needle has the oval ring plane and the one end is needle point, and a described oval ring plane wherein part embeds in the described substrate; Described shank is the hollow circular-tube that is embedded in the substrate or penetrates substrate, its bottom or protrusion or recessed concordant with described substrate lower surface;
Described empty micropin forms through hole type micropin with the break-through of substrate both sides or is closed in the shank bottom and forms blind hole type micropin.
Preferably, the oval ring plane of described syringe needle is cut one section arc surface at least and makes it have more corner angle.
Preferably, described empty micropin is arranged by setting spacing on described substrate, constitutes empty micropin array by at least two empty micropins, and described empty micropin array is through hole type microneedle array or blind hole type microneedle array, or both mixing array.
Preferably, be parallel to each other between the oval ring plane of each described empty micropin or arrange at an angle.
Preferably, described substrate is to be difficult for diastrophic rigid substrate or can diastrophic flexible substrate, and the upper and lower surface of substrate is plane or curved surface.
Preferably, described substrate is single structure, perhaps comprises the upper strata substrate and the underlying substrate that stack from top to bottom, and described shank penetrates described upper strata substrate at least along certain angle.
Preferably, be provided with some needle stands between described upper strata substrate and the underlying substrate, described shank is fixed on the described substrate by described needle stand, and described each needle stand is fixed an empty micropin at least.
Preferably, the set angle of described shank inclination is 15～165 degree.
Preferably, described empty micropin adopts the metal or alloy material to make, and includes but not limited in titanium, copper, aluminum, ferrum, nickel, tungsten, rustless steel, titanium alloy, aluminium alloy, nickel alloy, the copper alloy any one or a few.
Preferably, the material that described substrate adopts is a kind of in weaving cotton cloth of plastics, resin, rubber, textile fiber or elastic fiber or non-woven fabrics, leather or the artificial leather, or several layerings combine, and connect by fusion, bonding, stitching, binding agent, permeability-reducing admixture or fixed structure between each layer.
Preferably, described empty micropin and/or substrate surface are coated with one deck or some layer films, and described thin film includes but not limited to dielectric material thin film or gold, silver, titanium, chromium, nickel, platinum or its alloy firm.
Preferably, the material that adopts of described needle stand is one or more the combination in resin, plastics, metal or alloy, the rubber.
Preferably, the oval ring plane of described syringe needle and the angle of shank axis are the 5-80 degree, and needle length is 10 μ m-3000 μ m; The shank external diameter is 5 μ m-1000 μ m, and interior warp is 1-800 μ m, and length is 10 μ m-5000 μ m.
Preferably, when described substrate was single structure, its thickness was 10 μ m-5000 μ m; When described substrate comprised the upper strata substrate that stacks and underlying substrate, the thickness of described upper strata substrate and underlying substrate was 1 μ m-3500 μ m.
Preferably, described needle stand thickness is 0.05 μ m-3000 μ m.
The present invention also provides a kind of preparation method of empty micropin array chip, comprises step:
S1, select for use some syringe needles to have the empty micropin on oval ring plane, and with its according to a determining deviation vertically or at an angle insert or penetrate the preparation substrate material, form the blank of empty micropin array chip, wherein, described empty micropin has through hole or blind hole, described oval ring plane or cut one section arc surface at least and make its existence more multi-angular;
S2, the lower surface of the substrate of the described blank of grinding and polishing or by the outstanding needle tubing of lower surface to target substrate thickness and shape;
S3 cuts the empty micropin array chip that described substrate forms preliminary dimension and shape.
Preferably, described step S1 comprises step:
S1-1 vertically or at an angle penetrates the material that forms the upper strata substrate with described some empty micropins according to a determining deviation;
S1-2 is fixed as one underlying substrate and upper strata substrate and cuts into required size.
Preferably, after step S1-1, described method also comprises step:
S1-1 ' utilizes figure to shift or screen printing technique prepares the needle stand array at the downside of upper strata substrate.
For solving above-mentioned second technical problem, a kind of empty micropin percutaneous dosing paster is provided, it comprises empty micropin array chip and percutaneous patch, described percutaneous patch covers in the syringe needle oval ring surface and through hole/blind hole of empty micropin at least, and it is made of thin film or the thick-film material that one or more layers comprises one or more materials.
Preferably, described material contains one or more natural or synthetic ingredients with treatment or prevent disease or mind ﹠ body care effect, or having a natural or synthetic cosmetics and skincare product of beauty treatment, skin protection, face-nursing function, it is one or more the mixture in solid, liquid, microgranule, emulsifiable paste, colloid, colloidal sol, gel, plaster, the ointment.
Preferably, described empty micropin array chip is pasted on the middle part of medical proof fabric or adhesive tape, and the medical thin-film material covering adhesive plaster that usefulness is easy to peel off or all the other of adhesive tape have glue zone and empty micropin array with protection micropin, patch and adhesive plaster.
The present invention also provides a kind of preparation method of empty micropin percutaneous dosing paster, and it comprises step: utilize the method for preparing empty micropin array chip; Method by dipping, coating, curing, physical property or chemical deposit covers the percutaneous patch at empty micropin array chip; The substrate back of empty micropin array chip is bonded in the centre that medical proof fabric has glue one side, and this side remainder glue face of adhesive plaster and chip surface are coated with the material film that is easy to peel off.
In order to solve above-mentioned the 3rd technical problem, the present invention also provides a kind of empty micropin percutaneous dosing device or cosmetic device, it comprises empty micropin array chip and pedestal, described empty micropin array chip is permanent or removably be fixed on an end of pedestal, the other end of described pedestal has is convenient to manual plane and/or curved handle arrangement, and described pedestal is solid or hollow base.
Preferably, the combination of described hollow base and empty micropin array chip can form the structure with inner chamber, has passage or interface that inside intracavity adds medicinal liquid on the described hollow base.
Preferably, have the movable piston structure of rigidity and/or elasticity on the described hollow base, described piston structure only pushes away the medicinal liquid in the inner chamber under external force by empty micropin array.
Preferential, have on the described pedestal administration device is fixed in the fixed structure of executing the pin position.
Preferably, the combination of one or more in described pedestal employing metal, glass, resin, plastics, pottery, rubber or the composite is made.
Preferably, the combination of one or more in the cloth of described fixed structure employing metal, plastics, polymer, leather, rubber, various materials or fiber, magic tape, medical proof fabric, the composite is made.
The present invention also provides the preparation method of a kind of empty micropin percutaneous dosing device or cosmetic device, and it comprises: utilize the method for preparing empty micropin array chip; Include but not limited to that bonding, fusion, bonding, bayonet socket or mechanical pressing are permanent or removably be fixed on an end of pedestal with described empty micropin array chip, the various materials in the described hollow base and ingredient adopt and include but not limited to that bonding, fusion, stitching, bonding, bayonet socket, screw socket or mechanical pressing mode assemble.
(3) beneficial effect
Empty micropin array chip of the present invention is firm in structure, needle point is sharp, be convenient to puncture, and cost is low, yield rate is high, is suitable for making in batches.Micropin length controlled in the array is strong, high conformity, does not have pain during use, loses blood, uses the rapid spontaneous recovery of skin meeting of back Wicresoft, and is safe and reliable.Can utilize the through hole at syringe needle place or blind hole structure as drug storage warehouse based on the percutaneous dosing paster of empty micropin array chip, can obviously increase the drug storage amount and can reduce greatly and execute pin process Chinese medicine and come off in external probability, thus can make transdermal patch select the medicine scope, effectively treatment time and cost performance are significantly improved.Adopt the device of the present invention's preparation not only can significantly improve the transdermal penetration rate that has medicine now, make medicine or cosmetics and skincare product enter epidermal area and skin corium by horny layer rapidly, obviously improve drug effect or looks improving and the skin nourishing effect, can also expand the kind that is suitable for medicine, develop the more percutaneous novel form of multiple medicines thing and cosmetics.
Description of drawings
Fig. 1 be in the embodiment of the invention syringe needle some embeds a kind of empty micropin array chip structural representation in substrate perpendicular to substrate and oval ring plane;
Fig. 2 is a kind of empty micropin array chip structural representation that the oval ring interplanar of different micropins in the embodiment of the invention distributes at an angle;
Fig. 3 is positioned at a kind of empty micropin array chip structural representation on the substrate for syringe needle in the embodiment of the invention perpendicular to substrate and oval ring plane;
Fig. 4 is positioned at a kind of empty micropin array chip structural representation on the substrate for syringe needle in the embodiment of the invention favours substrate and oval ring plane;
Fig. 5 is positioned on the substrate for each syringe needle oval ring plane in the embodiment of the invention and all is a kind of blind hole type micro-needle array chip structure cutaway view of blind hole;
Fig. 6 be each syringe needle in the embodiment of the invention the oval ring plane some embed in substrate and all be a kind of blind hole type micro-needle array chip structure cutaway view of blind hole;
Fig. 7 be in the embodiment of the invention oval ring plane on the syringe needle not entirely on substrate and all be a kind of blind hole type micro-needle array chip structure cutaway view of blind hole;
Fig. 8 is that embodiment of the invention hollow core micropin is with a kind of through hole type micro-needle array chip structure cutaway view of substrate both sides break-through;
Fig. 9 is through hole in the embodiment of the invention and blind hole and a kind of mixed type micro-needle array chip structure cutaway view of depositing;
Figure 10 is sealed a kind of blind hole type micro-needle array chip structure cutaway view that forms blind hole for shank bottom in the embodiment of the invention by underlying substrate;
Figure 11 is fixed, seals a kind of blind hole type micro-needle array chip structure cutaway view that forms blind hole for every shank bottom in the embodiment of the invention by a needle stand;
Figure 12 is fixed, seals a kind of blind hole type micro-needle array chip structure cutaway view that forms blind hole for two shank bottoms in the embodiment of the invention by a needle stand;
Figure 13 A～Figure 13 C is preparation technology's schematic flow sheet of a kind of empty micropin array chip in the embodiment of the invention;
Figure 14 covers a kind of through hole type microneedle transdermal delivery paster structure cutaway view on the through hole syringe needle for percutaneous patch in the embodiment of the invention;
Figure 15 covers a kind of blind hole type microneedle transdermal delivery paster structure cutaway view on the blind hole syringe needle for percutaneous patch in the embodiment of the invention;
Figure 16 is a kind of percutaneous dosing device or cosmetic device structural representation that adopts solid base in the embodiment of the invention;
Figure 17 is a kind of percutaneous dosing device or cosmetic device structural representation that adopts hollow base in the embodiment of the invention.
Figure 18 is another kind of percutaneous dosing device or the cosmetic device structural representation that adopts hollow base in the embodiment of the invention.
Figure 19 is another kind of percutaneous dosing device or the cosmetic device structural representation that adopts hollow base in the embodiment of the invention.
Figure 20 is another kind of percutaneous dosing device or the cosmetic device structural representation that adopts hollow base in the embodiment of the invention.
Figure 21 is another kind of percutaneous dosing device or the cosmetic device structural representation that adopts hollow base in the embodiment of the invention.
Figure 22 is another kind of percutaneous dosing device or the cosmetic device structural representation that adopts hollow base in the embodiment of the invention.
Figure 23 is another kind of percutaneous dosing device or the cosmetic device structural representation that adopts hollow base in the embodiment of the invention.
Wherein, 1: substrate; 1a: upper strata substrate; 1b: underlying substrate; 2: syringe needle; 3: shank; 4: the oval ring plane; 5: needle point; 6: through hole or blind hole; 7: needle stand; 8: the percutaneous patch; 9: pedestal; 10: inner chamber; 11: add liquid passage or interface; 12: piston structure; 13: the elastomer in the piston; 14: the rigidity supporting structure in the piston: 15: bayonet socket or screw socket.
The specific embodiment
Below in conjunction with drawings and Examples, the specific embodiment of the present invention is described in further detail.Following examples are used for explanation the present invention, but are not used for limiting the scope of the invention.
Fig. 1-Figure 12 shows empty micropin array chip provided by the present invention, described empty micropin array chip comprises substrate 1 and the some empty micropins that are arranged on the described substrate 1, described some empty micropins are formed empty micropin array at a certain distance, described empty micropin comprises the syringe needle 2 that exposes substrate surface and is embedded in the interior shank 3 of substrate, described syringe needle 2 has oval ring plane 4 and the one end is needle point 5, be parallel to each other between the oval ring plane 4 of each described empty micropin or arrange at an angle or arbitrarily angled layout, described empty micropin forms through hole 6 with the break-through of substrate both sides or is closed in the shank bottom and forms blind hole 6.Described substrate 1 can comprise upper strata substrate 1a and the underlying substrate 1b that is superimposed, and described shank 3 penetrates described upper strata substrate 1a at least.Be provided with some needle stands 7 between described upper strata substrate 1a and the underlying substrate 1b, described shank 3 is fixed on the described substrate 1 by needle stand 7, and described each needle stand 7 is fixed an empty micropin at least.Described shank 3 can arrange that the certain angle that also can tilt is arranged on the described substrate 1 perpendicular to described substrate 1, preferred 15～165 degree in described angle of inclination.
Described substrate 1 is to be difficult for diastrophic rigid substrate or can diastrophic flexible substrate, and the upper and lower surface of substrate 1 is plane or curved surface.Preferably, the material that described substrate 1 adopts is that one or more layerings in weaving cotton cloth of plastics, polymer, resin, rubber, silicone rubber, latex, textile fiber or elastic fiber or non-woven fabrics, leather or the artificial leather combine, and connects by fusion, bonding, binding agent, stitching, permeability-reducing admixture or fixed structure between each layer.Preferably, described substrate 1 thickness is 10 μ m-5000 μ m, or the thickness of described upper strata substrate 1a and underlying substrate 1b is 1 μ m-3500 μ m.The material that described needle stand 7 adopts is one or more the combination in polymer, resin, metal or alloy, plastics, rubber, the binding agent.Preferably, the thickness of described needle stand 7 is 0.05 μ m-3000 μ m.
Described shank 3 is to have the metal circular pipe of setting interior external diameter, and described metal includes but not limited to any one or a few in titanium, copper, aluminum, ferrum, nickel, tungsten, rustless steel, titanium alloy, aluminium alloy, nickel alloy, the copper alloy.Described round tube is embedded in the substrate 1 or penetrates substrate 1, round tube bottom or protrusion or recessed concordant with substrate 1 lower surface.Preferably, shank 3 external diameters are 5 μ m-1000 μ m, and interior warp is 1-800 μ m, and length is 10 μ m-5000 μ m.The oval ring plane 4 of described syringe needle 2 is the 5-80 degree with the angle of shank 3 axis, and the length of syringe needle 2 is 10 μ m-3000 μ m.
Be monolayer, bilayer and have or not needle stand according to substrate 1, can be divided into single-layer substrate empty micropin array chip, the double-deck substrate empty micropin array chip of no needle stand roughly and the double-deck substrate empty micropin array chip of needle stand is arranged.The preparation method of these three kinds of empty micropin array chips is described in detail in detail below.
1) single-layer substrate empty micropin array chip
S1, some hollow metal micropins vertically or are at an angle inserted or penetrate the material of preparation substrate according to a determining deviation, form the blank of empty micropin array chip, the syringe needle of described micropin has the oval ring plane, and perhaps this plane is cut one section arc surface at least and makes its existence more multi-angular; In inserting the substrate process, can make as required between the oval ring plane of each empty micropin and be parallel to each other as shown in Figure 1, perhaps arrange at an angle as shown in Figure 2 or arbitrarily angled layout, and adjust needle point apart from substrate surface to the setting height shown in Fig. 1,3, and note making micropin height uniformity as far as possible on the same chip;
S2, the side-prominent needle tubing of the substrate lower surface of the described blank of grinding and polishing or lower surface one is to target substrate thickness and shape;
S3 cuts the empty micropin array chip that described substrate forms preliminary dimension and shape.
2) the double-deck substrate empty micropin array chip of no needle stand
S4 selects for use some syringe needles to have oval ring plane or this plane and is cut one section arc surface at least and make it have more multangular hollow metal needle tubing, and they vertically or are at an angle penetrated the material that forms the upper strata substrate according to a determining deviation;
S5 is fixed as one underlying substrate and upper strata substrate and cuts into required size.
3) the double-deck substrate empty micropin array chip of needle stand is arranged
Between step S4 and S5, utilize figure transfer or screen printing technique to prepare the needle stand array at the downside of upper strata substrate.
In the prior art, the metal tube grinding and polishing that medium dip is stretched out to the micro-needle array chip blank can form the syringe needle with oval ring plane, but this plane only may be positioned on the substrate, syringe needle becomes higher after adopting mechanical system to adjust the angle of inclination, the part that can not prepare the oval ring plane shown in Fig. 1,2,6,12 can be embedded in the chip structure in the substrate, the latter's syringe needle undoubtedly can be much lower, the degree of depth of thrusting skin like this can be more shallow, and using under situation about not affecting the treatment can be safer.Unlike the prior art, empty micropin structure of the present invention is straight, the centre can be crooked, and shown in 5～12, the manufacturing cost of micro-needle array chip is lower and be easy to prepare sharper syringe needle.
The manufacture method of hollow rustless steel micro-needle array chip
In each hole of via-hole array mould, insert an external diameter and be 250 microns, length and be 2 millimeters hollow rustless steel needle tubing, syringe needle 2 has oval ring plane 4, or this plane is cut one section arc surface at least and makes its existence more multi-angular, vertical or inclination certain angle inserts in the epoxy prepolymer solution for the preparation of epoxy resin base plate with shank 3 then, solidifies back formation micro-needle array chip blank through heated polymerizable.With the flat desired thickness that is polished to of substrate bottom one side grinding of this chip, thus the hollow rustless steel micro-needle array chip of the monolayer rigid substrate of formation shown in Fig. 1 and Fig. 3～9.
The manufacture method of hollow rustless steel micro-needle array chip
In each hole of via-hole array mould, insert an external diameter and be 250 microns, length and be 1.5 millimeters hollow rustless steel needle tubing, and syringe needle 2 has oval ring plane 4, or this plane is cut one section arc surface at least and makes its existence more multi-angular, vertical or inclination certain angle penetrates a non-woven fabrics 1a and stretches out 0.5 millimeter with syringe needle 2 then, at last one thick about 1 millimeter, surface are scribbled the sealed polyethylene plastic 1b of adhesive and above-mentioned non-woven fabrics 1a carry out bonding, thereby form the hollow rustless steel micro-needle array chip of double-deck flexible substrate as shown in figure 10.
The manufacture method of hollow rustless steel micro-needle array chip
Inserting an external diameter in each hole of via-hole array mould is 250 microns, length is that 2 millimeters and syringe needle 2 have oval ring plane 4 or this plane and cut one section arc surface at least and make it have more multangular hollow rustless steel needle tubing, vertical or inclination certain angle penetrates a non-woven fabrics 1a and stretches out 0.5 millimeter with syringe needle 2 then, and adopt the method for silk screen printing after rustless steel shank 3 bottoms apply epoxy resin cure, to form needle stand 7 arrays, at last with another piece non-woven fabrics 1b and above-mentioned non-woven fabrics 1a, needle stand 7 is sewed up or is bonding, thereby forms the hollow rustless steel micro-needle array chip that the double-deck flexible substrate of needle stand is arranged shown in Figure 11～13.
This embodiment provides a kind of percutaneous dosing paster based on empty micropin array chip or Beauty sticking piece, is made up of empty micropin array chip and percutaneous patch.Wherein, shown in Figure 14-15, percutaneous patch 8 covers in the needle surface and through hole or blind hole of empty micropin, even can also cover the substrate surface of chip, and it is made of the thin film that one or more layers comprises one or more materials.Preferably, at least include a kind of natural or synthetic cosmetics and skincare product that has the natural or synthetic medicine for the treatment of, diagnosis or preventive effect or have skin protection, skin care, whitening function in the described material, it is solid, liquid, microgranule, ointment, plaster, emulsifiable paste, colloid, colloidal sol, gel or several mixture wherein.Preferably, empty micropin array chip is pasted on the middle part of medical proof fabric or adhesive tape, all the other that cover adhesive plaster or adhesive tape with the medical thin-film material that is easy to peel off have glue zone and empty micropin array, with protection micropin, patch and adhesive plaster.Paster can be for circle or ellipse or polygon or other required form, such as the shape that matches with site of administration.
If make transdermal patch, adopt the administering effect of the chip structure shown in Fig. 1 and Fig. 2 or Fig. 6～9 may not have obvious difference, but may there be larger difference in their specious degree, manufacturing cost and yield rate.Compare with blind hole type micro-needle array chip, the manufacturing cost of through hole type micro-needle array chip will increase greatly, yield rate may obviously descend.
This embodiment provides a kind of preparation method of percutaneous dosing paster and the Beauty sticking piece based on empty micropin array chip.Described method covers the percutaneous patch by the method for dipping, coating, curing, physical property or chemical deposit at empty micropin array chip; In order to strengthen the coverage effect on syringe needle, can in the percutaneous patch, add dispersant, viscosifier, solvent, surfactant; The substrate back of empty micropin array chip is bonded in the centre that medical proof fabric has glue one side; adhesive plaster uses covering one deck separate paper or other adherent layer material with protection micropin and patch at remainder glue face and the chip surface of this side, can be easy in use itself and paster are peeled off.
This embodiment provides a kind of empty micropin percutaneous dosing device or cosmetic device, and it is made up of empty micropin array chip and pedestal.Wherein, the permanent or dismountable end that is fixed on pedestal 9 of empty micropin array chip, pedestal 9 can be solid base or hollow base, has at the other end of pedestal and is convenient to manual plane and/or curved handle arrangement, as shown in figure 16.Preferably, the combination of hollow base and empty micropin array chip can form the structure with inner chamber 10, and has on the hollow base to inner chamber 10 interior passage or the interfaces 11 that add medicinal liquid, as shown in figure 17.Preferably, also have rigidity and/or the movable piston structure of elasticity on the hollow base, shown in Figure 18～23, these piston structures can only push away the medicinal liquid in the inner chamber under external force by empty micropin array.In piston compressional movement process, the elastomer 13 in the described piston in Figure 20～23 can outwards be protruded by the pressure of inner chamber herb liquid; Wherein the combination of the screw socket that adopts in Figure 22～23 or bayonet arrangement 15 and elastomer 13 can realize in the administration process the controllably propelling to the inner chamber herb liquid to a certain extent.Controlled or the sustained-release administration process time is longer, be equipped with at pedestal the administration device is fixed in the fixed structure of executing the pin position, can adopt methods such as similar watchband or medical proof fabric to fix according to executing the pin position.
Preferably, the material that adopts of pedestal is one or more the combination in metal, glass, polymer, resin, plastics, pottery, rubber, silicone rubber or the composite.The combination of one or more in the cloth of described fixed structure employing metal, plastics, polymer, leather, rubber, various materials or fiber, magic tape, medical proof fabric, the composite is made.
Adopt the hollow base percutaneous to transport medicinal liquid and should select through hole type micro-needle array chip for use, if all micropins that require to pursue simply on the chip according to prior art are the through hole type, then the inevitable manufacturing cost that improve chip greatly, be significantly reduced to the product rate.The mixed type micro-needle array chip that the present invention allows to adopt through hole and blind hole and deposits, it is required much larger than reality usually mainly to be based on the micropin number that designs on the chip, and therefore occurring a limited number of blind hole type micropins in array chip can't exert an influence to the administration performance.So, the yield rate of chip will obviously improve undoubtedly, manufacturing cost reduces greatly.
This embodiment also provides the preparation method of a kind of empty micropin percutaneous dosing device or cosmetic device.That the employing method includes but not limited to is bonding, fusion, bonding, mechanical pressing, special construction or other modes with empty micropin array chip a permanent or dismountable end that is fixed on pedestal, the various materials in the hollow base and ingredient adopt and include but not limited to that bonding, fusion, stitching, bonding, mechanical pressing, special construction or other modes assemble and guarantee the air-tightness of binding site in the use.
As can be seen from the above embodiments, empty micropin array chip of the present invention is firm in structure, needle point is sharp, be convenient to puncture, and cost is low, yield rate is high, be suitable for manufacturing in batches.Micropin high conformity in the array does not have pain, loses blood during use, use the rapid spontaneous recovery of skin meeting of back Wicresoft, and is safe and reliable.Can utilize the through hole at syringe needle place or blind hole structure as drug storage warehouse based on the percutaneous dosing paster of empty micropin array chip, can obviously increase the drug storage amount and can reduce greatly and execute pin process Chinese medicine and come off in external probability, thus can make transdermal patch select the medicine scope, effectively treatment time and cost performance are significantly improved.Adopt the device of the present invention's preparation not only can significantly improve the transdermal penetration rate that has medicine now, make medicine or cosmetics and skincare product enter epidermal area and skin corium by horny layer rapidly, obviously improve drug effect or looks improving and the skin nourishing effect, can also expand the kind that is suitable for medicine, develop the more percutaneous novel form of multiple medicines thing and cosmetics.
The above only is preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the technology of the present invention principle; can also make some improvement and modification, these improve and modification also should be considered as protection scope of the present invention.
Claims (27)
1. an empty micropin array chip comprises substrate and empty micropin, it is characterized in that, described empty micropin comprises syringe needle and shank, and described empty micropin is fixed on the described substrate by described shank and to described substrate tilting set angle;
Described syringe needle has the oval ring plane and the one end is needle point, and a described oval ring plane wherein part embeds in the described substrate; Described shank is the hollow circular-tube that is embedded in the substrate or penetrates substrate, its bottom or protrusion or recessed concordant with described substrate lower surface;
Described empty micropin forms through hole type micropin with the break-through of substrate both sides or is closed in the shank bottom and forms blind hole type micropin.
2. empty micropin array chip as claimed in claim 1 is characterized in that, the oval ring plane of described syringe needle is cut one section arc surface at least makes it have more corner angle.
3. empty micropin array chip as claimed in claim 1 or 2, it is characterized in that, described empty micropin is arranged by setting spacing on described substrate, constitute empty micropin array by at least two empty micropins, described empty micropin array is through hole type microneedle array or blind hole type microneedle array, or both mixing array.
4. empty micropin array chip as claimed in claim 3 is characterized in that, is parallel to each other between the oval ring plane of each described empty micropin or arranges at an angle.
5. empty micropin array chip as claimed in claim 3 is characterized in that, described substrate is rigid substrate or flexible substrate, and the upper surface of substrate and lower surface are plane or curved surface.
6. empty micropin array chip as claimed in claim 3 is characterized in that, described substrate is single structure, perhaps comprises the upper strata substrate and the underlying substrate that stack from top to bottom, and described shank penetrates described upper strata substrate at least along certain angle.
7. empty micropin array chip as claimed in claim 6 is characterized in that, is provided with some needle stands between described upper strata substrate and the underlying substrate, and described shank is fixed on the described substrate by described needle stand, and described each needle stand is fixed an empty micropin at least.
8. empty micropin array chip as claimed in claim 1 is characterized in that, the set angle of 15～165 degree that tilt between described shank and the described substrate.
9. empty micropin array chip as claimed in claim 1, it is characterized in that, described empty micropin adopts the metal or alloy material to make, and comprises in titanium, copper, aluminum, ferrum, nickel, tungsten, rustless steel, titanium alloy, aluminium alloy, nickel alloy, the copper alloy any one or a few.
10. empty micropin array chip as claimed in claim 1, it is characterized in that, the material that described substrate adopts is a kind of in the weaving cotton cloth of weaving cotton cloth of plastics, resin, rubber, textile fiber or elastic fiber, non-woven fabrics, leather or the artificial leather, or several layerings combine, and connect by fusion, bonding, stitching, binding agent, permeability-reducing admixture or fixed structure between each layer.
11. as claim 9 or 10 described empty micropin array chips, it is characterized in that, described empty micropin and/or substrate surface are coated with one deck or some layer films, and described thin film comprises dielectric material thin film or gold, silver, titanium, chromium, nickel, platinum or its alloy firm.
12. empty micropin array chip as claimed in claim 7 is characterized in that, the material that described needle stand adopts is one or more the combination in resin, metal or alloy, plastics, the rubber.
13. empty micropin array chip as claimed in claim 1 is characterized in that, the oval ring plane of described syringe needle and the angle of shank axis are the 5-80 degree, and needle length is 10 μ m-3000 μ m; The shank external diameter is 5 μ m-1000 μ m, and internal diameter is 1-800 μ m, and length is 10 μ m-5000 μ m.
14., it is characterized in that when described substrate was single structure, its thickness was 10 μ m-5000 μ m as claim 6 or 7 described empty micropin array chips; When described substrate comprised the upper strata substrate that stacks and underlying substrate, the thickness of described upper strata substrate and underlying substrate was 1 μ m-3500 μ m.
15. empty micropin array chip as claimed in claim 7 is characterized in that, described needle stand thickness is 0.05 μ m-3000 μ m.
16. empty micropin percutaneous dosing paster, it is characterized in that, described empty micropin percutaneous dosing paster comprises empty micropin array chip and percutaneous patch, described empty micropin array chip is each described empty micropin array chip among the claim 1-15, described percutaneous patch covers in the syringe needle oval ring surface and through hole or blind hole of empty micropin at least, and it is made of thin film or the thick-film material that one or more layers comprises one or more materials.
17. empty micropin percutaneous dosing paster as claimed in claim 16, it is characterized in that, described material contains one or more natural or synthetic ingredients with treatment or prevent disease or mind ﹠ body care effect, or having the natural or synthetic cosmetics and skincare product of beauty treatment, skin protection, face-nursing function, it is solid or liquid or described solid and mixtures of liquids.
18. empty micropin percutaneous dosing paster as claimed in claim 17 is characterized in that, described solid is microgranule, emulsifiable paste, colloid, and described liquid is colloidal sol.
19. empty micropin percutaneous dosing paster as claimed in claim 18 is characterized in that, described emulsifiable paste is plaster or ointment.
20. empty micropin percutaneous dosing paster as claimed in claim 18 is characterized in that, described colloid is colloidal sol or gel.
21. as claim 16 or 17 described empty micropin percutaneous dosing pasters; it is characterized in that; described empty micropin percutaneous dosing paster also comprises medical proof fabric or adhesive tape; described empty micropin array chip is pasted on the middle part of described medical proof fabric or adhesive tape; all the other of described adhesive plaster or adhesive tape have glue zone and empty micropin array to be coated with the medical thin-film material that is easy to peel off, with protection micropin, patch and adhesive plaster.
22. an empty micropin percutaneous dosing device or cosmetic device, it is characterized in that, described empty micropin percutaneous dosing device or cosmetic device comprise empty micropin array chip and pedestal, described empty micropin array chip is each described empty micropin array chip among the claim 1-15, described empty micropin array chip is permanent or removably be fixed on an end of pedestal, the other end of described pedestal has is convenient to manual plane or curved handle arrangement, and described pedestal is solid or hollow base.
23. empty micropin percutaneous dosing device as claimed in claim 22 or cosmetic device, it is characterized in that, the combination of described hollow base and empty micropin array chip forms has the structure of inner chamber, has passage or interface that inside intracavity adds medicinal liquid on the described hollow base.
24. empty micropin percutaneous dosing device as claimed in claim 23 or cosmetic device, it is characterized in that, have the movable piston structure of rigidity or elasticity on the described hollow base, described piston structure only pushes away the medicinal liquid in the inner chamber under external force by empty micropin array.
25. as claim 22-24 each described empty micropin percutaneous dosing device or cosmetic device, it is characterized in that, have on the described pedestal administration device or cosmetic device are fixed in the fixed structure of executing the pin position.
26. empty micropin percutaneous dosing device as claimed in claim 25 or cosmetic device is characterized in that, the combination of one or more in described pedestal employing metal, glass, resin, plastics, pottery, rubber or the composite is made.
27. empty micropin percutaneous dosing device as claimed in claim 25 or cosmetic device, it is characterized in that the combination of one or more in the cloth of described fixed structure employing metal, plastics, leather, rubber, various materials or fiber, magic tape, medical proof fabric, the composite is made.
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| CN 201010256734 CN101912663B (en) | 2010-08-18 | 2010-08-18 | Empty micropin array chip, percutaneous dosing paster, device and manufacture method thereof |
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| CN 201010256734 CN101912663B (en) | 2010-08-18 | 2010-08-18 | Empty micropin array chip, percutaneous dosing paster, device and manufacture method thereof |
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