CN104096311B - Based on the manufacture method of the microneedle array of high voltage electric field - Google Patents
Based on the manufacture method of the microneedle array of high voltage electric field Download PDFInfo
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- CN104096311B CN104096311B CN201410308295.9A CN201410308295A CN104096311B CN 104096311 B CN104096311 B CN 104096311B CN 201410308295 A CN201410308295 A CN 201410308295A CN 104096311 B CN104096311 B CN 104096311B
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Abstract
The present invention relates to a kind of technical field of biomedical engineering method, more specifically, relate to a kind of manufacture method of the microneedle array based on high voltage electric field.Made by the setting of infusing device the speed of the inflow substrate mould of substrate mixture solution controlled, make it be uniformly distributed on substrate mould, avoid occurring piling up; The electric field utilizing electric field generation device to produce and substrate mixture solution interact, by the size of control voltage, substrate mixture solution is ionized on casement, forms taylor cone, namely microneedle array structure is formed, reduce the cost of manufacture of microneedle array structure, make the manufacture method of micropin technology simple and easy to operate.
Description
Technical field
The present invention relates to a kind of technical field of biomedical engineering method, more specifically, relate to a kind of manufacture method of the microneedle array based on high voltage electric field.
Background technology
In therapeutic treatment field, although present the biotechnology many very ripe and effective medicines of production department, the transmission of many medicines is subject to some restrictions, is exactly the most significantly the injection of the oral of medicine and medicine.
The main problem of oral administration medicine supplying is just the Degradation of medicine in the gastrointestinal tract and the discharge by liver drug.The approach of another kind of usual dispensing is through intravenous injection, and this method not easily uses in non-medical place, also bad maintenance and control the release of medicine, and for inconvenience patient, has pain.Transmitting medicine by skin is very attractive novel method, but this method is restricted due to the permeability of skin extreme difference.Microneedle array provides a kind of method of novel transmission medicine, can strengthen through the transmission of skin to drug molecule, realizes efficient, painless dispensing.Microneedle array thrusts skin, creates the conduit by horny layer transmission medicine, once medicine is through horny layer, it just can be spread rapidly by deep tissues and by capillary absorbance below, form administration system.
Micropin is widely used at biomedical sector, such as, for biomedical measurement system, and drug delivery system and microsampling analytical system etc.Micropin not only volume is small, and also has accurately in performance, painless, and efficiently, feature easily, the advantage making it apply more strengthens, and the scope of corresponding application is more widened.
The method of current making micropin is not too many, to be the processing of microneedle array be the wherein a kind of effective way of the LIGA technology based on MEMS (MEMS technology).LIGA technology is a kind of advanced manufacturing technology utilizing synchrotron radiation X-ray to manufacture three-dimension device.It is made up of the preparation of X-ray mask plate, synchronous X-ray lithography, microstructural mold, micro-electroforming and micro-duplication process, can carry out the production in enormous quantities of micro element, cost is reduced greatly by LIGA technology.But due to synchronous X-ray costly and fabrication cycle long, the cost of LIGA fabrication techniques micropin is very high, and process complexity is wayward.
Early stage micropin is mainly using silicon as material, not high owing to having mechanical strength, and fragility is large, easily ruptures, is still not clear with the biocompatibility of human body, processing charges still more high defect, and present stage does not have condition and the potentiality of popularization.Metal micro-needle is except having except significant advantage in physical and mechanical properties, mechanical property, still certain shortcoming is had in biocompatibility, and course of processing more complicated, the metal micro-needle obtained acquires a certain degree of difficulty in medicine carrying and drug release, and effect is not necessarily desirable.And curable degradable high polymer material feature that is low with its processing cost and that be suitable for producing in enormous quantities demonstrates outstanding advantage, and this high molecular polymer micropin has good biocompatibility.In addition, this degradable polymeric material micropin can realize direct medicine carrying, can directly medicine be joined in the middle of the biomaterial that can be degraded by human body, directly pin inserted human body and discharge medicine, avoid that metal micro-needle medicine carrying extracts after loading time break and fall to causing micropin to stay human body.Especially, this curable degradable macromolecule polymer material cost is low, having can the advantage of direct medicine carrying, the mechanical strength of micropin can be realized by changing polymeric material, and treatment technology is ripe, in addition its formability and the compatibility more excellent, be suitable for the batch production of micropin.
Summary of the invention
The object of the invention is to overcome the deficiencies in the prior art, a kind of manufacture method of the microneedle array based on high voltage electric field is provided, made by the setting of infusing device the speed of the inflow substrate mould of substrate mixture solution controlled, make it be uniformly distributed on substrate mould, avoid occurring piling up; The electric field utilizing electric field generation device to produce and substrate mixture solution interact, by the size of control voltage, substrate mixture solution is ionized on casement, forms taylor cone, namely microneedle array structure is formed, reduce the cost of manufacture of microneedle array structure, make the manufacture method of micropin technology simple and easy to operate, the technical process of MEMS technology complexity can be avoided, be convenient to realize batch production.
For solving the problems of the technologies described above, the technical solution used in the present invention is:
A kind of manufacture method of the microneedle array based on high voltage electric field is provided, making apparatus based on microneedle array comprises substrate mould, has the casement of some apertures, for generate high voltage electric field electric field generation device, for substrate mixture solution being injected the infusing device of substrate mould, described infusing device is connected with substrate mould, and the manufacture method of microneedle array comprises the following steps:
A. make substrate mixture solution, described substrate mixture solution is that the medicament mixed of being injected by epoxy resin, epoxy curing agent, needs forms, and is loaded in infusing device by the substrate mixture solution of mix homogeneously;
B. casement is positioned over the upper surface of substrate mould, open in the basad mould of infusing device and inject substrate mixture solution, the some apertures on casement are placed in the top of substrate mixture solution;
C. the substrate mould of step b is positioned in electric field generation device, by the size of control voltage, substrate mixture solution is ionized on casement, forms the microneedle array structure of stable curing.
The present invention is based on the manufacture method of the microneedle array of high voltage electric field, by having built substrate mixture solution and the substrate mould that upper surface is placed with casement is positioned in electric field generation device, substrate mixture solution can be made to ionize and to form taylor cone on casement, form the microneedle array structure of stable curing.And due to substrate mixture solution comprise needs injection medicine and other materials degradable in vivo, avoid the misery that patient needs to extract micropin in medication process.Making apparatus structure is simple, can reduce the cost of manufacture of micropin.
In order to substrate die table places substrate mixture solution, the surface of described substrate mould is provided with the groove for placing substrate mixture solution, and described casement is positioned in groove, and the size of described casement and the size of groove match.The size of casement and the size of groove match in order to avoid casement is positioned in groove and slide, and make it place steadily, are convenient to producing of microneedle array structure.
In order to simplify the generating mode of electric field, substrate mixture solution can be ionized, described electric field generation device comprises high-voltage DC power supply, plate electrode and electrode slice, and described plate electrode is located at the top of groove, and described electrode slice is located in groove simultaneously; The earth terminal of described high-voltage DC power supply is connected with plate electrode, voltage output end is connected with electrode slice.High voltage direct current source generator adopts HVDC constant current source, and the voltage that high-voltage DC power supply exports can carry out coarse adjustment and fine setting.
In order to impel the microneedle array in step c Structured cured, described making apparatus also comprises the solidification equipment for being cured to the micropin on substrate mould.Micropin need select for the formation of micropin and curable degradable substrate mixture solution.In order to accelerate the solidification of micropin, curable condition can be selected according to the condition of cure of selected curable materials, selecting corresponding solidification equipment to be cured the micropin formed.Curing is mainly heating and curing, radiation curing, microwave curing etc., and concrete curing mode makes material according to selected micropin and specifically determines.
Be more prone to make mixture solution form micropin, described infusing device comprises for providing the syringe pump of propulsive force and the syringe for installing substrate mixture solution to syringe, and described substrate mold bottom is provided with the intercommunicating pore be communicated with infusing device; Described syringe is connected with connecting hole by rubber hose.Described infusing device needs strictly to control it and injects speed and flow when injecting, in the aperture that substrate mixture solution is injected on casement, reach the top of aperture and do not overflow casement surface for excellent with mixture solution.
In order to avoid substrate mould is by the impact of uniform magnetic field, described substrate mould is non-conducting material structure, and described casement is dull and stereotyped dielectric materials structure.Preferably, substrate mould is glass material structure, and casement is silicane rubber plate.Substrate mould is the setting of glass material structure is because glass material can not be subject to electric field influence, and the dielectric constant of the glass material of substrate mould is larger than the dielectric constant of the silicane rubber plate material of casement, make the glass material as substrate mould not affect the electric field of formation and the electric field influence formed casement is remarkable, and transparent being easy to is observed.Casement is silicane rubber plate, and advantage has excellent heat-resistant air aging property, ozone resistance, insulating properties, and fuel oil resistance and lubricating oil, can be placed in air under the condition of temperature-60 ~+250 DEG C or oil based media.Silicane rubber plate inherits the good characteristic of silica gel, has the feature of dielectricity, corrosion-resistant, high temperature high voltage resistant, colorless and odorless.In addition, silicane rubber plate has low-k, is placed under high voltage electric field, and the internal field that the aperture above it is formed is equivalent to the internal field that sharp-pointed metal needle produces.
Preferably, the aperture of the some apertures on described casement is 0.3 ~ 0.5mm, and the spacing between described some apertures is 15 ~ 30mm.The aperture of some apertures is 0.3 ~ 0.5mm is the preferably aperture of experimentally measuring, and the size in aperture can affect the diameter of micropin, and can affect the distribution number of aperture on casement.Spacing between some apertures is for 15 ~ 30mm is that the electric field produced between adjacent holes interferes with each other.
Substrate mixture solution is by curable degradable macromolecular material, needs the medicament mixed of injection to form, solidification equipment can be taken according to the condition of cure of base mixture, and the substrate mixture solution of mix homogeneously is loaded on infusing device, just can open solidification equipment form pin under high voltage electric field after and micropin is cured.
In order to simplify the generating mode of electric field, substrate mixture solution can be ionized, the output end voltage of described high-voltage DC power supply is 1KV ~ 50KV simultaneously.High voltage power supply output voltage is 1KV-50KV, and 0 arrives ceiling voltage continuously adjustabe, can realize the control to different experimental conditions, improves the success rate that micropin is formed.Substrate mixture solution, mainly for generation of high voltage electric field, ionizes by high-voltage DC power supply, and therefore power does not need too large, and security performance is high.
Compared with prior art, the invention has the beneficial effects as follows:
The present invention is based on the manufacture method of the microneedle array of high voltage electric field, made by the setting of infusing device the speed of the inflow substrate mould of substrate mixture solution controlled, make it be uniformly distributed on substrate mould, avoid occurring piling up; The electric field utilizing electric field generation device to produce and substrate mixture solution interact, by the size of control voltage, substrate mixture solution is ionized on casement, forms taylor cone, namely microneedle array structure is formed, reduce the cost of manufacture of microneedle array structure, make the manufacture method of micropin technology simple and easy to operate.Substrate mixture solution of the present invention mixes by curable macromolecular material and medicine the polymer solution formed, without the need to extracting after its micropin formed can directly act on human body, medicine can be directly released into human body lentamente, realize the direct transmission of medicine, and its one-tenth needle material can in people's vivo degradation.The present invention can change microneedle array length and micropin thickness by regulating the pore size of some apertures on high-voltage DC power supply voltage, pore membrane and the group grading mode of mixture solution, the shape of micropin is made to have controllability, and making apparatus structure is simple, with low cost, easy to use.
Accompanying drawing explanation
Fig. 1 is the structural representation of embodiment 1 substrate mould.
Fig. 2 is the structural representation of embodiment 1 casement.
Fig. 3 is the making apparatus structural representation that embodiment 1 adds microneedle array before casement.
Fig. 4 is the structural representation after embodiment 1 microneedle array makes molding.
Fig. 5 is the structural representation of the making apparatus of embodiment 2 microneedle array.
Detailed description of the invention
Below in conjunction with detailed description of the invention, the present invention is further illustrated.Wherein, accompanying drawing only for exemplary illustration, expression be only schematic diagram, but not pictorial diagram, can not be interpreted as the restriction to this patent; In order to better embodiments of the invention are described, some parts of accompanying drawing have omission, zoom in or out, and do not represent the size of actual product; For a person skilled in the art, in accompanying drawing, some known features and explanation thereof may be omitted is understandable.
The corresponding same or analogous parts of same or analogous label in the accompanying drawing of the embodiment of the present invention, in describing the invention, it will be appreciated that, if have term " on ", D score, " left side ", orientation or the position relationship of the instruction such as " right side " are based on orientation shown in the drawings or position relationship, only the present invention for convenience of description and simplified characterization, instead of indicate or imply that the device of indication or element must have specific orientation, with specific azimuth configuration and operation, therefore the term of position relationship is described only for exemplary illustration in accompanying drawing, the restriction to this patent can not be interpreted as, for the ordinary skill in the art, the concrete meaning of above-mentioned term can be understood as the case may be.
Embodiment 1
As shown in Figures 1 to 4 for the present invention is based on the first embodiment of the manufacture method of the microneedle array of high voltage electric field, as shown in Figure 4, making apparatus based on microneedle array comprises substrate mould 1, has the casement 2 of some apertures, for generate high voltage electric field electric field generation device 3, for substrate mixture solution being injected the infusing device 4 of substrate mould 1, infusing device 4 is connected with substrate mould 1, and the manufacture method of microneedle array comprises the following steps:
A. make substrate mixture solution, described substrate mixture solution is that the medicament mixed of being injected by epoxy resin, epoxy curing agent, needs forms, and is loaded in infusing device 4 by the substrate mixture solution of mix homogeneously;
B. casement 2 is positioned over the upper surface of substrate mould 1, open in the basad mould 1 of infusing device 4 and inject substrate mixture solution, the some apertures on casement 2 are placed in the top of substrate mixture solution;
C. the substrate mould 1 of step b is positioned in electric field generation device 3, by the size of control voltage, substrate mixture solution is ionized on casement 2, forms the microneedle array structure of stable curing.
Particularly, as shown in Figure 1, the surface of substrate mould 1 is provided with the groove 11 for placing substrate mixture solution, and casement 2 is positioned in groove 11, and the size of casement 2 and the size of groove 11 match.The size of casement 2 and the size of groove 11 match in order to avoid casement 2 is positioned in groove 11 and slide, and make it place steadily, are convenient to producing of microneedle array structure.The substrate mould 1 selected in the present embodiment is square structure; Groove 11 is square groove, and long is 150mm, and wide is 100mm, and the degree of depth is 2mm.
Wherein, as shown in Figure 3 to Figure 4, electric field generation device 3 comprises high-voltage DC power supply 31, plate electrode 32 and electrode slice 33, and plate electrode 32 is located at the top of groove 11, and electrode slice 33 is located in groove 11; The earth terminal of high-voltage DC power supply 31 is connected with plate electrode 32, voltage output end is connected with electrode slice 33.High voltage direct current source generator adopts HVDC constant current source, and the voltage that high-voltage DC power supply 31 exports can carry out coarse adjustment and fine setting.The output end voltage of high-voltage DC power supply 31 is 1KV ~ 50KV.High compacting stream power supply 31 output voltage is 1KV-50KV, and 0 arrives ceiling voltage continuously adjustabe, can realize the control to different experimental conditions, improves the success rate that micropin is formed.Substrate mixture solution, mainly for generation of high voltage electric field, ionizes by high-voltage DC power supply 31, and therefore power does not need too large, and security performance is high.
In addition, as shown in Figs. 3-4, making apparatus also comprises the curing source of the micropin solidification for being formed to casement 2 on substrate mould 1.The curing source of the application adopts heating source.Heating source comprises and is positioned over heating film 5 bottom substrate mould 1 and for providing the extraneous DC source 6 of power supply to heating film 5, heating film 5 is carbon fibre material formation.Heating film 5 for the setting that carbon fibre material is formed be because carbon fiber electrically thermal conversion efficiency is high, long service life, fatigue durability is high, and can not be subject to externally-applied magnetic field impact.By to heating film 5 pairs of substrate mixture solution heating, accelerate epoxy resin cure, namely accelerate the solidification of microneedle array structure.
Wherein, infusing device 4 comprises for providing the syringe pump of propulsive force and the syringe for installing substrate mixture solution to syringe, is provided with the intercommunicating pore 12 be communicated with infusing device 4 bottom substrate mould 1; Syringe is connected with connecting hole 12 by rubber hose 7.Infusing device 4 needs strictly to control it and injects speed and flow when injecting, in the aperture that substrate mixture solution is injected on casement 2, reach the top of aperture and do not overflow casement 2 surface for excellent with mixture solution.There is aperture to draw rubber hose 7 bottom groove 11 and connect infusing device 4, and bottom groove 11, be fixed with electrode slice 33, fully to contact with the substrate mixture solution of injecting groove 11 and to ionize.
In addition, substrate mould 1 is non-conducting material structure, and casement 2 is dull and stereotyped dielectric materials structure.In the present embodiment, substrate mould 1 is glass material structure, and casement 2 is silicane rubber plate.Substrate mould 1 is the setting of glass material structure is because glass material can not be subject to electric field influence, and transparent being easy to is observed.As shown in Figure 2, the aperture of the some apertures on casement 2 is 0.3 ~ 0.5mm, and the spacing between some apertures is 15 ~ 30mm.The aperture of some apertures is 0.3 ~ 0.5mm is the preferably aperture of experimentally measuring, and the size in aperture can affect the diameter of micropin, and can affect the distribution number of aperture on casement.Spacing between some apertures is for 15 ~ 30mm is that the electric field produced between adjacent holes interferes with each other.The number of its aperture can design according to practical situation, and select aperture to be the aperture of 0.4mm in the present embodiment, pitch-row is 20mm, casement 2 is uniformly distributed 35 apertures, 7, long limit, minor face 5.
In addition, the weight ratio of the fractions of substrate mixture solution is, epoxy resin: epoxy curing agent=3:1.The setting of the weight ratio of the composition of substrate mixture solution is the generation quality that the deficiency of waste and mixed proportion in order to not cause material affects micropin.
Operating procedure concrete in the present embodiment is as follows:
Step one: make the groove structure substrate mould 1 of glass material, it is long is 150mm, and wide is 100mm, is 2mm deeply, to be connected to be communicated with infusing device 4 by substrate mould 1 by rubber hose 7 with connecting hole 12.
Step 2: etched on silicane rubber plate by laser and form casement 2.Aperture pitch-row on casement 2 is 0.4mm, casement 2 is uniformly distributed 35 apertures, 7, long limit, minor face 5.
Step 3: make substrate mixture solution.The weight ratio of its epoxy resin and epoxy curing agent is 3:1.
Step 4: utilize infusing device 4 to draw substrate mixture solution, and infusing device 4 is connected to connection bottom groove 11 by rubber hose 7 by aperture 12, and high-voltage DC power supply 31 voltage output end is connected with the electrode slice 33 be fixed on bottom groove 11.
Step 5: be positioned in groove 11 by casement 2, the plate electrode 3 that will be connected to high-voltage DC power supply 4 earth terminal is placed in distance groove 11 opening 4mm place.
Step 6: start infusing device 4, injected in groove 11 by substrate mixture solution, until substrate mixture solution arrives casement 2 top and stops when not overflowing aperture injecting.
Step 7: open high-voltage DC power supply 31 switch, boosted voltage gradually from 0kV, finely tunes when being elevated to 3kV, utilizes magnifier to observe, until there is micropin, keep this voltage.
Step 8: place the heating film 5 that a slice is electrically connected with extraneous DC source 6 below substrate mould 1, open extraneous DC source 6, regulating it to export DC voltage is 5.0V, the temperature of heating film 8 is 90 to 130 DEG C at this voltage, to the heating of substrate mould 1 until microneedle array structure is solidified completely, form microneedle array.
Embodiment two
Be illustrated in figure 5 the second embodiment of the manufacture method of the microneedle array that the present invention is based on high voltage electric field, the present embodiment and embodiment one similar, institute's difference is, aperture is selected to be the aperture of 0.5mm in the present embodiment, pitch-row is 30mm, casement 2 is uniformly distributed 35 apertures, 7, long limit, minor face 5.In the present embodiment, substrate mould 1 does not add heating source, the direct air-dry solidification of microneedle array structure, escapable cost.
Obviously, the above embodiment of the present invention is only for example of the present invention is clearly described, and is not the restriction to embodiments of the present invention.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here exhaustive without the need to also giving all embodiments.All any amendments done within the spirit and principles in the present invention, equivalent to replace and improvement etc., within the protection domain that all should be included in the claims in the present invention.
Claims (9)
1. the manufacture method based on the microneedle array of high voltage electric field, it is characterized in that, making apparatus based on microneedle array comprises substrate mould (1), has the casement (2) of some apertures, for generate high voltage electric field electric field generation device (3), for substrate mixture solution being injected the infusing device (4) of substrate mould (1), described infusing device (4) is connected with substrate mould (1), and the manufacture method of microneedle array comprises the following steps:
A. make substrate mixture solution, described substrate mixture solution is by curable degradable macromolecular material, needs the medicament mixed of injection to form, and is loaded in infusing device (4) by the substrate mixture solution of mix homogeneously;
B. casement (2) is positioned over the upper surface of substrate mould (1), open in infusing device (4) basad mould (1) and inject substrate mixture solution, the some apertures on casement (2) are placed in the top of substrate mixture solution;
C. the substrate mould (1) of step b is positioned in electric field generation device (3), by the size of control voltage, substrate mixture solution is ionized on casement (2), forms the microneedle array structure of stable curing.
2. the manufacture method of the microneedle array based on high voltage electric field according to claim 1, it is characterized in that, the surface of described substrate mould (1) is provided with the groove (11) for placing substrate mixture solution, described casement (2) is positioned in groove (11), and the size of described casement (2) and the size of groove (11) match.
3. the manufacture method of the microneedle array based on high voltage electric field according to claim 2, it is characterized in that, described electric field generation device (3) comprises high-voltage DC power supply (31), plate electrode (32) and electrode slice (33), described plate electrode (32) is located at the top of groove (11), and described electrode slice (33) is located in groove (11); The earth terminal of described high-voltage DC power supply (31) is connected with plate electrode (32), voltage output end is connected with electrode slice (33).
4. the manufacture method of the microneedle array based on high voltage electric field according to any one of claims 1 to 3, is characterized in that, described making apparatus also comprises the curing source for the micropin solidification formed to the upper casement (2) of substrate mould (1).
5. the manufacture method of the microneedle array based on high voltage electric field according to any one of claims 1 to 3, it is characterized in that, described infusing device (4) comprises for providing the syringe pump of propulsive force and the syringe for installing substrate mixture solution to syringe, and described substrate mould (1) bottom is provided with the connecting hole (12) be communicated with infusing device (4); Described syringe is connected with connecting hole (12) by rubber hose.
6. the manufacture method of the microneedle array based on high voltage electric field according to claim 1, is characterized in that, described substrate mould (1) is non-conducting material structure, and described casement (2) is dull and stereotyped dielectric materials structure.
7. the manufacture method of the microneedle array based on high voltage electric field according to claim 1, is characterized in that, the aperture of the some apertures on described casement (2) can adjust according to specific requirement, and the spacing between described some apertures is 15 ~ 30mm.
8. the manufacture method of the microneedle array based on high voltage electric field according to claim 1, is characterized in that, the fractions of described substrate mixture solution comprises curable degradable high molecular polymer.
9. the manufacture method of the microneedle array based on high voltage electric field according to claim 3, is characterized in that, the output end voltage of described high-voltage DC power supply can adjust according to concrete curable materials, and scope is 1KV ~ 50KV.
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| CN104307097B (en) * | 2014-10-28 | 2017-04-05 | 中山大学 | A kind of manufacture method of flexible substrates metal micro-needle array |
| KR101691403B1 (en) * | 2014-10-30 | 2017-01-03 | 서울대학교산학협력단 | Method for manufacturing electro induced microstructure and manufacturing apparatus for the same |
| EP3416620B1 (en) | 2016-02-15 | 2024-04-03 | Shanghai Jiao Tong University | Method to print microneedle patches rapidly |
| EP3338853A1 (en) | 2016-12-23 | 2018-06-27 | Sanofi-Aventis Deutschland GmbH | Medicament delivery device |
| CN106727273A (en) * | 2017-03-02 | 2017-05-31 | 李成国 | The manufacture method of soluble micropin |
| CN108714273B (en) * | 2018-06-08 | 2021-02-05 | 广州蔻原生物科技有限责任公司 | Polymer microneedle preparation system and polymer microneedle preparation method |
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