CN201564970U - Transdermal medicine supply patch based on micro needle array flexible chip - Google Patents
Transdermal medicine supply patch based on micro needle array flexible chip Download PDFInfo
- Publication number
- CN201564970U CN201564970U CN 200920110575 CN200920110575U CN201564970U CN 201564970 U CN201564970 U CN 201564970U CN 200920110575 CN200920110575 CN 200920110575 CN 200920110575 U CN200920110575 U CN 200920110575U CN 201564970 U CN201564970 U CN 201564970U
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- Prior art keywords
- microneedle array
- micropin
- substrate
- flexible
- chip
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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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The utility model discloses a micro needle array flexible chip, which comprises a flexible substrate, two or more than two micro needles arrayed on the flexible substrate at a certain interval; each micro needle comprises a needle bar and a needle point positioned at the tip of the needle bar; and the micro needle is fixed on the flexible substrate through the lower part of the needle bar. The utility model can lead medicine or beauty skin care products to rapidly enter an epidermal layer and a dermis layer through a horny layer due to organic combination between the micro needle array and the flexible substrate, thereby obviously improving medicinal the medical effect or beautifying and face-nourishing effect, and realize batch manufacture with low cost, high yield and high repeatability by utilizing the mature processing technology.
Description
Technical field
This utility model relates to medical treatment and beauty treatment instrument technical field, particularly relates to a kind of microneedle array flexible chip and based on the percutaneous dosing paster 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, is meant 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 of treatment.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 is transmitted, 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 pushing 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: 1) earlier microneedle array is thrust skin and form hole, again medicated patches is applied on therapentic part for solid microneedles; 2) behind microneedle array surface-coated medicine, thrust skin and continue release.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 is used for manufacturing needles acupuncture needle or existing thousand one-hundred-year histories of injection needle, and the safety of its use is unquestionable.At present, some solid metal micro-needle array chip structure and manufacture methods thereof have been reported both at home and abroad, these technology all are to form the microneedle array of different shape and perpendicular to its substrate on a nugget genus, preparation method comprises following several: 1) adopt mode cutting metal plates such as chemical attack or cut and form various planes micropin figure thereon, utilize method such as punching press with these plane micropin perks and final vertical with this metallic plate then; 2) metal sheet surface is carried out optionally electrolysis or electrochemical corrosion to form the micropin of projection.But the micro-needle array chip of employing metal basal board is difficult for the shape of applying skin, and use feeling is comfortable inadequately, convenient.
The utility model content
A purpose of the present utility model provides a kind of microneedle array flexible chip that can overcome weak point in the prior art.
For achieving the above object, a kind of microneedle array flexible chip structure according to this utility model embodiment is provided, comprise flexible substrate, and two or more, be arranged in micropin on the described flexible substrate at a certain distance, described micropin comprises shank and is positioned at the vertical needle point of shank that described micropin is fixed on the described flexible substrate by the bottom of shank.
Preferably, the shank of micropin is cylinder or cone.
Preferably, the needle point of described micropin is taper shape, pyramid or wedge shape.
Preferably, described needle point has upper surface parallel with flexible substrate or the inclination certain angle, and described upper surface is an elliptic plane.
Preferably, have some pits on the described elliptic plane.
Preferably, the elliptic plane of described needle point is cut one section arc surface at least and makes it have more corner angle.
Preferably, described flexible substrate comprises upper strata substrate and the underlying substrate that is superimposed, and the bottom of described micropin penetrates described upper strata substrate along certain angle.
Preferably, be provided with some needle stands between described upper strata substrate and the underlying substrate, the bottom of described micropin is fixed on the described flexible substrate by needle stand, and described each needle stand is fixed one or more micropins.
Preferably, the angle that is of the bottom of described micropin and described flexible substrate is 15 °-90 °.
Preferably, the angle that is of the top of described micropin and described flexible substrate is 15 °-160 °.
Preferably, the material that described micropin adopts is a metal or alloy, can be in titanium, copper, aluminum, ferrum, nickel, tungsten, rustless steel, titanium alloy, aluminium alloy, nickel alloy, copper alloy or other metal or alloy any one.
Preferably, the smooth surface of described micropin or have groove or pit.
Preferably, the micropin surface coverage has one deck or several layers dielectric material thin film or gold, titanium, nickel, platinum film or other metal or alloy thin film.
Preferably, the needle point radius of curvature of described micropin or equivalent radius of curvature are 1nm-800 μ m, and the shank external diameter is 5 μ m-800 μ m, highly are 10 μ m-9000 μ m.
Preferably, described flexible substrate by textile fiber or elastic fiber weave cotton cloth or non-woven fabrics, leather or artificial leather, rubber, latex, silicone rubber, plastics, polymer in one or more layerings combine, connect by fusion, bonding, binding agent, permeability-reducing admixture or fixed structure between each layer.
Preferably, the thickness of described upper strata substrate and underlying substrate is 1 μ m-8000 μ m.
Preferably, the material that adopts of described needle stand is one or more the combination in metal or alloy, resin, plastics, rubber, latex, silicone rubber or the polymer.
Preferably, described needle stand thickness is 0.1 μ m-5000 μ m.
Another purpose of the present utility model provides a kind of preparation method of microneedle array flexible chip.
This utility model also provides a kind of percutaneous dosing paster, and described percutaneous dosing paster comprises microneedle array flexible chip, and is covered in the percutaneous patch on the described microneedle array flexible chip, and described percutaneous patch contains one or more medicines or cosmetics and skincare product.
Preferably, described percutaneous patch also comprises one or more in rubber mass, pressure sensitive adhesive matrix, hydrogel matrix or other gel matrixes.
Preferably, the flexible substrate upper surface at the microneedle array flexible chip at described percutaneous dosing paster edge is protruding with flexibility or the elasticity antiseepage packing ring that is not higher than the micropin height.
Preferably, the making material of described antiseepage packing ring is one or more in weaving cotton cloth of textile fiber or elastic fiber or non-woven fabrics, leather or artificial leather, rubber, silicone rubber, latex, colloidal sol, gel, plastics, the polymer.
Preferably, micropin one side surface at described percutaneous dosing paster is coated with adherent layer with protection micropin and patch.
Preferably, be distributed with through hole area and/or needleless district on described percutaneous dosing paster, described through hole area and needleless district are respectively circle or ellipse or polygon or other special shapes that cooperates with site of administration.
Preferably, the edge paster in through hole area or needleless district is provided with flexibility or elasticity antiseepage packing ring, and its material is any one in weaving cotton cloth of textile fiber or elastic fiber or non-woven fabrics, leather or artificial leather, rubber or silicone rubber, latex, colloidal sol, gel, plastics, the polymer.
This utility model adopts flexible percutaneous dosing paster, the Beauty sticking piece of conventional at present medical material manufacturing based on the metal micro-needle array flexible chip, combination by microneedle array and flexible substrate can make medicine or cosmetics and skincare product enter epidermal area and skin corium by horny layer rapidly, thereby obviously improve drug effect or looks improving and the skin nourishing effect, and utilize sophisticated processing technique to realize the batch manufacturing of its low cost, high finished product rate, high duplication; Because the flexible substrate that adopts is easy and skin is conformal, uses and feel more comfortable, convenient; Microneedle configuration is firm, needle point is sharp, be convenient to puncture; 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 avoid or reduce the use of chemical penetrating agent, not only can significantly improve the transdermal penetration rate of existing medicine, can also expand the kind that is suitable for medicine, developing more, the percutaneous of multiple medicines thing and cosmetics transports product.
Description of drawings
Fig. 1 be among this utility model embodiment conical needle perpendicular to a kind of microneedle array flexible chip structural representation of flexible substrate;
Fig. 2 be among this utility model embodiment conical needle perpendicular to the another kind of microneedle array flexible chip structural representation of flexible substrate;
Fig. 3 be among this utility model embodiment cylindrical needle perpendicular to a kind of microneedle array flexible chip structural representation of flexible substrate;
Fig. 4 is the elliptic plane of needle point among this utility model embodiment a kind of microneedle array flexible chip structural representation parallel with flexible substrate;
Fig. 5 favours a kind of microneedle array flexible chip structural representation of flexible substrate for the elliptic plane of needle point among this utility model embodiment;
Fig. 6 is parallel with flexible substrate and have a kind of microneedle array flexible chip structural representation of corner angle for the elliptic plane of needle point among this utility model embodiment;
Fig. 7 favours flexible substrate for the elliptic plane of needle point among this utility model embodiment and has a kind of microneedle array flexible chip structural representation of corner angle;
Fig. 8 is that this utility model embodiment middle and upper part shank and bottom shank are all perpendicular to a kind of microneedle array flexible chip structure cutaway view of flexible substrate;
Fig. 9 is a kind of microneedle array flexible chip structure cutaway view that the shank upper and lower tilts with respect to flexible substrate respectively among this utility model embodiment;
Figure 10 all has a kind of microneedle array flexible chip structure cutaway view of a needle stand perpendicular to flexible substrate and every needle set for this utility model embodiment middle and upper part shank and bottom shank;
Figure 11 is this utility model embodiment middle and upper part shank and bottom shank are all shared a needle stand perpendicular to flexible substrate and per two pins a kind of microneedle array flexible chip structure cutaway view;
Figure 12 tilts with respect to flexible substrate respectively for the upper and lower of shank among this utility model embodiment and every needle set has a kind of microneedle array flexible chip structure cutaway view of a needle stand;
Figure 13 A～Figure 13 D is a kind of preparation technology's schematic flow sheet that the microneedle array flexible chip of needle stand is arranged among this utility model embodiment;
Figure 14 A～Figure 14 F a kind ofly among this utility model embodiment does not have needle stand but needs selective corrosion to make preparation technology's schematic flow sheet of the microneedle array flexible chip of needle point;
Figure 15 has the microneedle transdermal delivery paster of flexible barrier packing ring or a structure cutaway view of Beauty sticking piece for a kind of among this utility model embodiment;
Figure 16 is a kind of percutaneous dosing paster or a Beauty sticking piece structural representation based on microneedle array flexible chip among this utility model embodiment;
Figure 17 is for a kind of based on microneedle array flexible chip and have the percutaneous dosing paster or the Beauty sticking piece structural representation of flexible barrier packing ring among this utility model embodiment;
Figure 18 is for a kind of based on microneedle array flexible chip and have percutaneous dosing paster or the Beauty sticking piece structural representation that inside and outside flexible barrier packing ring, centre have through hole among this utility model embodiment;
Figure 19 is for a kind of based on microneedle array flexible chip and have the percutaneous dosing paster or the Beauty sticking piece structural representation of inside and outside flexible barrier packing ring, the no through hole in centre among this utility model embodiment.
Wherein, 1: flexible substrate; 2: micropin; 3: shank; 4: needle point; 5: the upper strata substrate; 6: underlying substrate; 7: upper surface; 8: corner angle; 9: pit; 10: needle stand; 11: masking film; 12: the antiseepage packing ring.
The specific embodiment
Below in conjunction with drawings and Examples, the specific embodiment of the present utility model is described in further detail.Following examples are used to illustrate this utility model, but are not used for limiting scope of the present utility model.
Embodiment 1
Fig. 1-Figure 12 shows microneedle array flexible chip provided by the utility model, described microneedle array flexible chip comprises flexible substrate 1 and the some micropins 2 that are arranged on the described flexible substrate 1, described some micropins 2 are formed microneedle array at a certain distance, described micropin 2 comprises shank 3 and is positioned at shank 3 vertical needle points 4 that described micropin 2 is fixed on the described flexible substrate 1 by the bottom of shank 3.Described flexible substrate 1 can comprise upper strata substrate 5 and the underlying substrate 6 that is superimposed, and the bottom of described micropin 2 penetrates described upper strata substrate 5 at least.Described micropin 2 can arrange that the certain angle that also can tilt is arranged on the described flexible substrate 1, preferred 15 °-90 ° of described angle perpendicular to described flexible substrate 1.
Fig. 1 and Fig. 2 are respectively among this utility model embodiment conical needle perpendicular to a kind of microneedle array flexible chip structural representation of flexible substrate, Fig. 3 be among this utility model embodiment cylindrical needle perpendicular to a kind of microneedle array flexible chip structural representation of flexible substrate.Preferably, described flexible substrate by textile fiber or elastic fiber weave cotton cloth or non-woven fabrics, leather or artificial leather, rubber, latex, silicone rubber, plastics, polymer in one or more layerings combine, connect by fusion, bonding, binding agent, permeability-reducing admixture or fixed structure between each layer.Preferably, the thickness of described upper strata substrate and underlying substrate is 1 μ m-8000 μ m.
The needle point 4 of described micropin 2 can be the various three-dimensional shapes that have the tip, preferred conical, pyramid or wedge shape, described needle point 4 has the upper surface 7 of or inclination certain angle parallel with described flexible substrate 1, described upper surface 7 is an elliptic plane, or further processing of this elliptic plane made its existence more multi-angular 8 and/or pit 9.Fig. 4 is the parallel a kind of microneedle array flexible chip structural representation of elliptic plane and the flexible substrate 1 of needle point 4 among this utility model embodiment; Fig. 5 favours a kind of microneedle array flexible chip structural representation of flexible substrate 1 for the elliptic plane of needle point 4 among this utility model embodiment; Fig. 6 exists corner angle and the microneedle array flexible chip structural representation parallel with flexible substrate 1 for the elliptic plane of needle point 4 among this utility model embodiment; There are corner angle in Fig. 7 for the elliptic plane of needle point 4 among this utility model embodiment and favour a kind of microneedle array flexible chip structural representation of flexible substrate 1.Wherein, elliptic plane is 0 °-90 ° with respect to the angle of inclination preferable range of flexible substrate.
Preferably, the upper and lower of shank 3 can be respectively to flexible substrate 1 inclination set angle separately.Preferred 15 °-90 ° of the angle that the bottom of described shank 3 and described flexible substrate 1 are, preferred 45 °-135 ° of the angle that the top of described shank 3 and described flexible substrate 1 are.Fig. 8 is that the upper and lower of shank 3 among this utility model embodiment is all perpendicular to a kind of microneedle array flexible chip structure cutaway view of flexible substrate 1; Fig. 9 is a kind of microneedle array flexible chip structure cutaway view that the upper and lower of shank 3 among this utility model embodiment tilts with respect to flexible substrate 1 respectively.
Preferably, be provided with some needle stands 10 between described upper strata substrate 5 and the underlying substrate 6, the bottom of described shank 3 is fixed on the described flexible substrate 1 by needle stand 10, and described each needle stand 10 is fixed one or more micropins 2.Preferably, described needle stand thickness is 0.1 μ m-5000 μ m.Preferably, the combination of one or more in described needle stand employing metal or alloy, resin, plastics, rubber, silicone rubber or the polymer.Figure 10 all has a kind of microneedle array flexible chip structure cutaway view of a needle stand perpendicular to flexible substrate and every micropin 2 for the upper and lower of shank 3 among this utility model embodiment; Figure 11 is the upper and lower shank of shank 3 among this utility model embodiment is all shared needle stands 10 perpendicular to flexible substrate 1 and per two micropins 2 a kind of microneedle array flexible chip structure cutaway view; Figure 12 tilts with respect to flexible substrate 1 respectively for the upper and lower of shank among this utility model embodiment and every micropin 2 has a kind of microneedle array flexible chip structure cutaway view of a needle stand 10.
Preferably, described micropin adopts metal or alloy, for example any one in titanium, rustless steel, titanium alloy, aluminium alloy, copper alloy, the tungsten.The smooth surface of described micropin or have groove or pit.The micropin surface can be coated with one deck or several layers dielectric material thin film or metallic film, the preferred gold of described metallic film, titanium, nickel, platinum film.The needle point radius of curvature of described micropin or equivalent radius of curvature are 1nm-800 μ m, and the shank external diameter is 5 μ m-800 μ m, highly are 10 μ m-9000 μ m.
Whether exist according to needle point and to have or not needle stand 10 can be divided into non-oval needle point roughly in the upper surface 7 that contains elliptic plane and the flexible substrate and do not have the microneedle array flexible chip of needle stand, non-oval needle point and the microneedle array flexible chip of needle stand, oval needle point are arranged and do not have the microneedle array flexible chip of needle stand, oval needle point and the microneedle array flexible chip of needle stand is arranged.Structure of these four kinds of microneedle array flexible chips and preparation method thereof is described in detail in detail below.
1) non-oval needle point and do not have the needle stand microneedle array flexible chip
In the present embodiment, the upper and lower of the shank 3 of micropin 2 and the angle of flexible substrate are respectively 15 °-160 ° and 15 °-90 °, and described micropin 2 is cylinder or cone.The needle point 4 of micropin 2 is taper shape or pyramid or wedge shape; Flexible substrate 1 is combined by upper strata substrate 5 and underlying substrate 6; Micropin is fixed on the flexible substrate by bottom shank 3.
The preparation method of said chip comprises step:
S1, the metal needle that will have taper shape or pyramid or wedge shape needle point 4 vertically or along certain angle tilts to penetrate upper strata flexible substrate 5;
S2 forms the microneedle array flexible chip blank behind the cut-out metal needle;
S3 carries out underlying substrate 6 and upper strata substrate 5 bonding;
S4, when there was different angles in the upper and lower of the shank 3 that designs, the micropin angle of inclination was further adjusted on the top that can utilize baffle plate to promote shank 3.
2) non-oval needle point and the microneedle array flexible chip of needle stand is arranged
In the present embodiment, the angle of the upper and lower of shank 3 and flexible substrate 1 is respectively 15 °-160 ° and 15 °-90 °, and described micropin 2 is cylinder or cone.The needle point 4 of micropin 2 is taper shape or pyramid or wedge shape; Flexible substrate is combined by upper strata substrate 5 and underlying substrate 6, is embedding needle stand 10 arrays therebetween; Micropin 2 is fixed on the flexible substrate 1 by the bottom and the needle stand 10 of shank 3.
The preparation method of said chip comprises step:
S1, the metal needle that will have taper shape or pyramid or wedge shape needle point 4 vertically or along certain angle tilts to penetrate upper strata substrate 5;
S2 forms the microneedle array flexible chip blank behind the cut-out metal needle;
S3 utilizes figure to shift or screen printing technique is produced needle stand 10 arrays at the incision position of metal needle;
S4 carries out underlying substrate 6 and upper strata substrate 5, needle stand 7 bonding;
S5, when there was different angles in the upper and lower of the shank 3 that designs, the angle of inclination of micropin 2 was further adjusted on the top that can utilize baffle plate to promote shank 3.
3) oval needle point and do not have the microneedle array flexible chip of needle stand
In the present embodiment, the angle of the upper and lower of shank 3 and flexible substrate 1 is respectively 15 °-160 ° and 15 °-90 °, and described micropin 2 is cylinder or cone.Needle point 4 upper surfaces are parallel with flexible substrate or tilt to set the elliptic plane 7 of acute angle; Or this plane 7 is removed one section arc surface at least and makes it have more corner angle 8, also can be removed a part simultaneously and form pit 9 in the middle of elliptic plane.Flexible substrate 1 is combined by upper strata flexible substrate 5 and lower floor's flexible substrate 6; Micropin 2 is fixed on the flexible substrate 1 by the bottom of shank 3.
The preparation method of said chip comprises step:
S1 tilts to penetrate upper strata substrate 5 with cylindrical or conical metal bar along certain angle;
S2 cuts off metal bar respectively and the fracture grinding and polishing is formed elliptic plane 7 on the needle point 4 along the direction parallel with upper strata substrate 5 in the above and below of upper strata substrate 5; Or further above flexible substrate 1 side apply masking film, utilize figure to shift or screen printing technique forms the masking film pattern of design at an end of metal bar; The metal bar of the not masked film of chemistry or electrochemical corrosion protection is removed masking film after forming required syringe needle, prepares to have more multi-angular 8 and the needle point 4 of pit 9;
S3 carries out underlying substrate 6 and upper strata substrate 5 bonding;
S4 when there is different angles in the upper and lower of the shank 3 that designs, can utilize baffle plate to promote the angle of inclination that micropin 2 is further adjusted on top.
4) oval needle point and the microneedle array flexible chip of needle stand is arranged
In the present embodiment, the angle of the upper and lower of shank 3 and flexible substrate 1 is respectively 15 °-160 ° and 15 °-90 °, and described micropin 2 is cylinder or cone.A kind of needle point 4 upper surfaces of micropin 2 are parallel with flexible substrate 1 or tilt to set the elliptic plane 7 of acute angle; Or this plane is removed one section arc surface at least and makes it have more corner angle 8, also can be removed a part simultaneously and form pit 9 in the middle of elliptic plane.Flexible substrate 1 is combined by upper strata substrate 5 and underlying substrate 6, is embedding the array of needle stand 10 therebetween; Micropin 2 is fixed on the flexible substrate 1 by the bottom and the needle stand 10 of shank 3.
The preparation method of said chip comprises step:
S1 tilts to penetrate upper strata substrate 5 with cylindrical or conical metal bar along certain angle;
S2 cuts off metal bar respectively and the fracture grinding and polishing is formed upper surface (elliptic plane) 7 on the needle point 4 along the direction parallel with substrate in the above and below of substrate; Or further above flexible substrate 1 side prepare masking film, utilize figure to shift or screen printing technique forms the masking film pattern of design at an end of metal bar; The metal bar of the not masked film of chemistry or electrochemical corrosion protection is removed masking film after forming required needle point, prepares to have more multi-angular 8 and the needle point 4 of pit 9;
S3, the incision position of metal bar utilizes figure transfer or screen printing technique to produce needle stand 10 arrays below upper strata substrate 5;
S4 carries out underlying substrate 6 and upper strata substrate 5, needle stand 10 bonding;
S5, when there was different angles in the upper and lower of the shank 3 that designs, the angle of inclination of micropin 2 was further adjusted on the top that can utilize baffle plate to promote shank 3.
For convenience of explanation, four kinds of methods of making microneedle array flexible chip have just been marked off above roughly.If adopt suitable masking film pattern, utilize the method for the oval needle point flexible chip of preparation also can prepare non-oval needle point flexible chip.
The material of making the flexible substrate employing is flexibility or elastomeric material, can be weaving cotton cloth or non-woven fabrics, leather or artificial leather, rubber, latex, silicone rubber, plastics, polymer of textile fiber or elastic fiber, combine or combine by a kind of layers of material wherein, binding agent or permeability-reducing admixture or fixed structure are arranged between each layer by different materials layering wherein.
Below be several manufacture methods of rustless steel microneedle array flexible chip
A. in each hole of via-hole array mould, insert an external diameter and be 150 microns stainless pin, these stainless pins are vertically penetrated a non-woven fabrics 5 after, with cutting machine apart from these stainless pins of the about 1mm of this cloth place cut-out.Adopt the method for silk screen printing after the stainless pin incision position applies epoxy resin cure, to form needle stand 10 arrays, at last another piece non-woven fabrics 6 and above-mentioned non-woven fabrics 5, needle stand 10 are carried out bonding, thereby form the rustless steel microneedle array flexible chip.
B. in each hole of via-hole array mould, insert an external diameter and be 150 microns stainless steel silk rod, then these rods are about the upper strata substrate (silastic-layer) 5 of 1mm along the certain angle penetration thickness.Adopt cutting machine to cut off these rods, and fracture surface is formed the needle point 4 with elliptic plane along direction grinding and polishing parallel with substrate or that tilt, as shown in FIG. 13A.Subzero 100 ℃ freezing after, the micropin angle of inclination can be further adjusted on the top that utilizes baffle plate to promote shank, shown in Figure 13 B.Adopt the method for silk screen printing after shank bottom incision position applies epoxy resin cure, to form needle stand 10 arrays, shown in Figure 13 C.At last another piece underlying substrate (silastic-layer) 6 and above-mentioned upper strata substrate (silastic-layer) 5, needle stand 10 are carried out bondingly, shown in Figure 13 D, thereby form the rustless steel microneedle array flexible chip.
C. in each hole of via-hole array mould, insert an external diameter and be 150 microns stainless steel silk rod, then these rods are about the upper strata substrate (silastic-layer) 5 of 1mm along the certain angle penetration thickness.Adopt cutting machine to cut off these rods, and fracture surface is formed the needle point 4 with elliptic plane along direction grinding and polishing parallel with substrate or that tilt, shown in Figure 14 A.Excellent array one side of silk in said chip applies one deck photoresist as shown in Figure 14B as masking film 11, and utilize figure transfer techniques in the conventional microelectronic technique that masking film 11 is optionally exposed and develop, thereby on the elliptic plane of needle point 4, form the masking film figure of design, shown in Figure 14 C.Utilize the silk rod on 10 pairs of chips of masking film to carry out optionally chemistry or electrochemical corrosion, thereby on the elliptic plane of needle point 4, form needle point 4 and pit 9 with corner angle.The chemical corrosion liquid that uses is that Baume degrees is 35～45 liquor ferri trichloridi, and etching time is 20～60min.During electrochemical corrosion, need microneedle array one side of chip substrate is immersed in the electrochemical corrosive liquid, this corrosive liquid comprises 16～38wt% ferric chloride 1000mL, 1～10vol% hydrochloric acid, 1～10vol% nitric acid, 0.1～0.5wt% potassium dichromate; The opposite side immersion of chip substrate is included in the conductivity water solution of 0.1～0.5wt%NaCl; All insert graphite electrode in above-mentioned two solution, add 5～25 volts of DC voltages therebetween, at first in the electrode of corrosive liquid, connect positive potential 2～10 minutes, then it is connect nagative potential 20～50 minutes.Shown in Figure 14 D, chip is immersed polished in stainless steel chemical polishing solution or the electrochemical polish liquid 2～10 minutes again behind the employing acetone removal masking film.Comprise 80～120g/L hydrochloric acid, 50～60g/L nitric acid and 150～200g/L phosphoric acid in the chemical brightening solution.Comprise 600mL/L phosphoric acid and 300mL/L sulphuric acid in the electrochemical polish liquid.During electrochemical polish, need the microneedle array one side immersion of chip substrate is connected in the electrochemical polish liquid of plumbous anelectrode, the opposite side of chip substrate immerses and is connected in 0.1～0.5wt%NaCl conductivity water solution of plumbous negative electrode, adds 8～10V DC voltage between two electrodes.Subzero 100 ℃ freezing after, the angle of inclination of micropin 2 can be further adjusted on the top that utilizes baffle plate to promote shank 3, shown in Figure 14 E.At last another piece underlying substrate (silastic-layer) 6 and above-mentioned upper strata substrate (silastic-layer) 5 are carried out bondingly, shown in Figure 14 F, thereby form the rustless steel microneedle array flexible chip.
Embodiment 2
This embodiment provides a kind of percutaneous dosing paster or Beauty sticking piece based on the metal micro-needle array flexible chip, and it is made up of metal micro-needle array flexible chip and its lip-deep percutaneous administration patch of application or cosmetic patch.Wherein, percutaneous administration patch or cosmetic patch are made of the thin film that one or more layers comprises one or more materials; At least include a kind of cosmetics and skincare product that has the medicine of treatment, diagnosis or preventive effect or have skin protection, skin care, whitening function in the described material, can also include rubber mass or pressure sensitive adhesive matrix or hydrogel matrix or other novel patch adhesive material in the described material; Described material is solid, liquid, microgranule, ointment, plaster, emulsifiable paste, colloid, colloidal sol, gel or wherein several mixtures.When having only liquid or ointment, can directly the microneedle patch of soaking into liquid and ointment be overlayed on the skin, this paster is with wherein liquid or ointment are salable at ordinary times standby in small plastic bag; Or after earlier being coated in liquid or ointment on the skin, be covered with microneedle patch again, it is standby that patch and paster can separate sealed storage at ordinary times.The flexible chip substrate of patch edges be protruding be not higher than the micropin height as Figure 15, flexibility or elasticity antiseepage packing ring 12 shown in Figure 17, its material is weaving cotton cloth of textile fiber or elastic fiber or non-woven fabrics, leather or artificial leather, rubber or silicone rubber, latex, colloidal sol, gel, plastics, polymer.In addition, can be coated with one deck separate paper or other adherent layer material with protection micropin and patch, when paster is applied to skin, it can be peeled off at micropin one side surface of percutaneous dosing paster or Beauty sticking piece.Paster is circle or ellipse or polygon or other required form, such as the shape that matches with site of administration.Be distributed with the through hole area or the via-hole array district of circle or ellipse or polygon or other shape on the paster; Or the microneedle array flexible substrate surface on the paster is distributed with the needleless district or the needleless array area of circle or ellipse or polygon or other shape; Or be distributed with above-mentioned through hole area and needleless district on the paster simultaneously.Flexibility or elasticity antiseepage packing ring 12 can be arranged, shown in Figure 18,19 on the edge paster in through hole area and needleless district.Inside and outside the needleless district of paster, can be coated with the percutaneous administration patch or the cosmetic patch of identical or different material and function respectively.
Introduce based on the percutaneous dosing paster of microneedle array flexible chip, the preparation method of Beauty sticking piece below.That described method adopts is bonding, fusion, bonding or other method are prepared protrusion at the edge of flexible chip substrate flexibility or elasticity antiseepage packing ring.On microneedle array even flexible substrate and antiseepage packing ring, cover percutaneous administration patch or cosmetic patch by dipping, coating, physical property or chemical deposit or other method; Cover one deck separate paper or other adherent layer material with protection micropin and patch in micropin one side of dosing paster or Beauty sticking piece, can be easy in use itself and paster are peeled off.
This utility model adopts flexible percutaneous dosing paster, the Beauty sticking piece of conventional at present medical material manufacturing based on the metal micro-needle array flexible chip, combination by microneedle array and flexible substrate can make medicine or cosmetics and skincare product enter epidermal area and skin corium by horny layer rapidly, thereby obviously improve drug effect or looks improving and the skin nourishing effect, and utilize sophisticated processing technique to realize the batch manufacturing of its low cost, high finished product rate, high duplication; Because the flexible substrate that adopts is easy and skin is conformal, uses and feel more comfortable, convenient; Microneedle configuration is firm, needle point is sharp, be convenient to puncture; 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 avoid or reduce the use of chemical penetrating agent, not only can significantly improve the transdermal penetration rate of existing medicine, can also expand the kind that is suitable for medicine, developing more, the percutaneous of multiple medicines thing and cosmetics transports product.
The above only is a preferred implementation of the present utility model; should be understood that; for those skilled in the art; under the prerequisite that does not break away from this utility model know-why; can also make some improvement and modification, these improve and modification also should be considered as protection domain of the present utility model.
Claims (21)
1. microneedle array flexible chip, it is characterized in that, described chip comprises flexible substrate, and two or more, be arranged in micropin on the described flexible substrate at a certain distance, described micropin comprises shank and is positioned at the vertical needle point of shank that described micropin is fixed on the described flexible substrate by the bottom of shank.
2. microneedle array flexible chip as claimed in claim 1 is characterized in that, the shank of described micropin is cylinder or cone.
3. microneedle array flexible chip as claimed in claim 2 is characterized in that, the needle point of described micropin is taper shape, pyramid or wedge shape.
4. microneedle array flexible chip as claimed in claim 2 is characterized in that, described needle point has upper surface parallel with flexible substrate or that tilt, and described upper surface is an elliptic plane.
5. microneedle array flexible chip as claimed in claim 4 is characterized in that, has some pits on the described elliptic plane.
6. as claim 4 or 5 described microneedle array flexible chips, it is characterized in that the elliptic plane of described needle point is cut one section arc surface at least makes it have more corner angle.
7. microneedle array flexible chip as claimed in claim 1 is characterized in that, described flexible substrate comprises upper strata substrate and the underlying substrate that is superimposed, and the bottom of described micropin penetrates described upper strata substrate along certain angle.
8. microneedle array flexible chip as claimed in claim 7, it is characterized in that, be provided with some needle stands between described upper strata substrate and the underlying substrate, the bottom of described micropin is fixed on the described flexible substrate by needle stand, and described each needle stand is fixed one or more micropins.
9. as claim 7 or 8 described microneedle array flexible chips, it is characterized in that the angle that the bottom of described micropin and described flexible substrate are is 15 °-90 °.
10. as claim 7 or 8 described microneedle array flexible chips, it is characterized in that the angle that the top of described micropin and described flexible substrate are is 15 °-160 °.
11. microneedle array flexible chip as claimed in claim 10 is characterized in that, the smooth surface of described micropin or have groove or pit.
12., it is characterized in that described micropin surface coverage has one deck or several layers thin film as claim 1 or 11 described microneedle array flexible chips, described thin film comprises dielectric material thin film or gold, titanium, nickel, platinum or its alloy firm.
13., it is characterized in that the needle point radius of curvature of described micropin or equivalent radius of curvature are 1nm-800 μ m as claim 1 or 10 described microneedle array flexible chips, the shank external diameter is 5 μ m-800 μ m, highly is 10 μ m-9000 μ m.
14. microneedle array flexible chip as claimed in claim 1, it is characterized in that, described flexible substrate comprise by textile fiber or elastic fiber weave cotton cloth or non-woven fabrics, leather or artificial leather, rubber, latex, silicone rubber, plastics, polymer in one or more layerings combine, connect by fusion, bonding, binding agent, permeability-reducing admixture or fixed structure between each layer.
15. microneedle array flexible chip as claimed in claim 7 is characterized in that, the thickness of described upper strata substrate and underlying substrate is 1 μ m-8000 μ m.
16. microneedle array flexible chip as claimed in claim 8 is characterized in that, described needle stand thickness is 0.1 μ m-5000 μ m.
17. a percutaneous dosing paster is characterized in that described percutaneous dosing paster comprises microneedle array flexible chip, and is covered in the percutaneous patch on the described microneedle array flexible chip, described percutaneous patch contains one or more medicines or cosmetics and skincare product.
18. percutaneous dosing paster as claimed in claim 17 is characterized in that, is protruding with flexibility or the elasticity antiseepage packing ring that is not higher than the micropin height at the flexible substrate upper surface of the microneedle array flexible chip at described percutaneous dosing paster edge.
19. as claim 17 or 18 described percutaneous dosing pasters, it is characterized in that, be coated with adherent layer with protection micropin and patch at micropin one side surface of described percutaneous dosing paster.
20., it is characterized in that be distributed with through hole area and/or needleless district on described percutaneous dosing paster, the shape in described through hole area and needleless district comprises circle, ellipse or polygon as claim 17 or 18 described percutaneous dosing pasters.
21. percutaneous dosing paster as claimed in claim 20, it is characterized in that, the edge paster in through hole area or needleless district is provided with flexibility or elasticity antiseepage packing ring, and its material comprises any one in weaving cotton cloth of textile fiber or elastic fiber or non-woven fabrics, leather or artificial leather, rubber or silicone rubber, latex, colloidal sol, gel, plastics, the polymer.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN 200920110575 CN201564970U (en) | 2009-07-31 | 2009-07-31 | Transdermal medicine supply patch based on micro needle array flexible chip |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200920110575 CN201564970U (en) | 2009-07-31 | 2009-07-31 | Transdermal medicine supply patch based on micro needle array flexible chip |
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| CN201564970U true CN201564970U (en) | 2010-09-01 |
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| CN102657914A (en) * | 2012-05-17 | 2012-09-12 | 吉林大学 | Micro-needle transdermal delivery patch with high penetration efficiency |
| CN102805896A (en) * | 2011-05-30 | 2012-12-05 | 惠觅宙 | Transdermal administration method, preparation and system |
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| CN101618250B (en) * | 2009-07-31 | 2013-06-05 | 清华大学 | Percutaneous dosing paster based on microneedle array flexible chip and preparation method thereof |
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| CN101618250B (en) * | 2009-07-31 | 2013-06-05 | 清华大学 | Percutaneous dosing paster based on microneedle array flexible chip and preparation method thereof |
| CN102805896A (en) * | 2011-05-30 | 2012-12-05 | 惠觅宙 | Transdermal administration method, preparation and system |
| CN102657914B (en) * | 2012-05-17 | 2015-05-20 | 吉林大学 | Micro-needle transdermal delivery patch with high penetration efficiency |
| CN102657914A (en) * | 2012-05-17 | 2012-09-12 | 吉林大学 | Micro-needle transdermal delivery patch with high penetration efficiency |
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