CN101856538B - Microneedles array, die casting method for manufacturing microneedle array and die for manufacturing microneedle array - Google Patents

Microneedles array, die casting method for manufacturing microneedle array and die for manufacturing microneedle array Download PDF

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Publication number
CN101856538B
CN101856538B CN 200910134816 CN200910134816A CN101856538B CN 101856538 B CN101856538 B CN 101856538B CN 200910134816 CN200910134816 CN 200910134816 CN 200910134816 A CN200910134816 A CN 200910134816A CN 101856538 B CN101856538 B CN 101856538B
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counterdie
mould
hole
plane
notch
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CN101856538A (en
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徐雁
容启亮
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Hong Kong Polytechnic University HKPU
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Hong Kong Polytechnic University HKPU
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023Drug applicators using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053Methods for producing microneedles

Abstract

The invention provides a microneedles array, a method for manufacturing the microneedles array and a die for manufacturing the microneedles array. The microneedles array comprises a base and a plurality of microneedles which are integrated with the base, wherein a liquid storage cavity is arranged in the base, and each microneedle are provided with micro-pinholes which are communicated with the liquid storage cavity; the microneedles array is made of plastics, composite materials, and ceramics or metal materials by injection molding; and each microneedle has at least one inclined surface which is inclined towards the central line of the microneedle, and the outlet of each micro-pinhole is positioned on at least one inclined surface, so that the end of the outlet of the microneedle forms apinnacle part. The die specialized for the invention comprises an upper die, a middle die and a lower die, wherein the middle die and the lower die are provided with cavities for forming the microneedles; and the upper die and the middle die are provided with grooves for forming the base. The three-plate die of the invention can be used for conveniently manufacturing the microneedles array with the pinnacles. Since the stripping process in the injection molding method using three layers of die comprising the upper die, middle die and lower die, the method has the advantages of small die drawing resistance and low manufacturing cost.

Description

Microneedle array, the die casting method of making this microneedle array and employed mould
Technical field
The present invention relates to a kind of employed particular manufacturing craft in the microneedle array of micro hole, the method for making this kind microneedle array and this method that has.
Background technology
The outermost skin layer of human body, for example horny layer is the best biological barrier protective layer of human body.Horny layer has fabulous electrical insulating property, can prevent effectively that extraneous liquid from getting into subcutaneous tissue, can prevent that also the subcutaneous tissue interstitial fluid from infiltrating simultaneously.At present at biomedical sector, subcutaneous administration (be about to medicinal liquid and directly be given to the subcutaneous tissue below the horny layer) and from the subcutaneous tissue interstitial fluid collecting test sample to treatment, diagnosing the illness becomes important just day by day.Needing in above-mentioned two kinds of operations to use can cuticular syringe needle of transdermal or microneedle array.
American documentation literature US6,471,903B2 has disclosed a kind of plastic cement empty micropin array structure, comprises pedestal and several micropins integrally formed with pedestal.Wherein has the liquid storage cylinder that is used to store medicinal liquid or interstitial fluid in the pedestal.Said micropin is hollow; Promptly has the center micro hole that communicates with the liquid storage cylinder of pedestal; This micropin that has micro hole has internal face and outside wall surface, the resistance when reducing transdermal, and the outside wall surface of micropin is processed taper; Thereby make that the leading section of micropin is relatively sharper, can be more laborsaving when using like this.This microneedle array can use two board molds to create through injection molding method.But because exit end face and its centrage of the micro hole of this kind micropin are vertical, resistance ratios suffered during transdermal is bigger, and especially when several micropins were formed microneedle array, suffered resistance was just bigger.At present, a kind of microneedle array with tip that is fabricated from a silicon has appearred.Because the material silicon of this kind microneedle array is relatively more expensive; This makes that the cost of microneedle array is too high, and microneedle array belongs to the Dispoable medical article, can not reuse; The microneedle array of excessive price is difficult to popularize and uses, so the poor practicability of the microneedle array of this kind silicon materials.Simultaneously, the microneedle array of this kind silicon materials is made by photoengraving technology, and photoengraving technology more complicated can only be produced single product at every turn, is difficult to realize mass production, and the technology cost is high.
Summary of the invention
The objective of the invention is to overcome the deficiency of above-mentioned prior art, suffered resistance was little when a kind of transdermal was provided, and the low microneedle array of cost;
Another object of the present invention provides a kind of method of making above-mentioned microneedle array;
The 3rd purpose of the present invention is to provide employed particular manufacturing craft in a kind of method of making above-mentioned microneedle array.
For realizing above-mentioned purpose, the present invention adopts following technical scheme:
Microneedle array of the present invention, comprise pedestal and with integrated several micropins of pedestal.Be provided with the liquid storage cylinder that is used to store medicinal liquid or interstitial fluid in the said pedestal, have the micro hole that is communicated with said liquid storage cylinder in said each micropin.Wherein said microneedle array is processed through injection molding technique by plastics, composite, pottery or metal material.Has the inclined-plane that at least one favours said micropin centrage on said each micropin; The outlet of micro hole is positioned at least one said inclined-plane; Inclined-plane on several micropins is centrosymmetric and arranges or the axial symmetry layout that the outlet end at micropin forms the spike part like this.
The quantity on said inclined-plane is one, and the outside wall surface of this inclined-plane and said micropin intersects the formation spike.
The quantity on said inclined-plane is two, and the internal face that this two inclined-plane intersects at said micropin forms spike, and the outlet of said micro hole is positioned on one of them said inclined-plane.
The quantity on said inclined-plane is two, intersects at the below of micro hole, and the outlet of said micro hole has two, lays respectively on said two inclined-planes these two outlet symmetric arrangement.
Wherein between said pedestal and said spike part, also has the needle body part.
Wherein the shape of cross section of several said micro holes is one or more the combinations in circle, ellipse, rectangle, triangle or " ten " word flower shape.
The cross sectional shape of said micropin is circle, ellipse or rectangle.
The exit of said micro hole is formed with thin film.
The centrage of said micro hole and the central lines of said micropin or depart from the position of center line of micropin.
Said several micropins are arranged to circle, rectangle, circular array or rectangular array.
The mould of manufacturing microneedle array of the present invention comprises patrix and middle mould.Wherein said patrix comprises upper substrate and several core rods that are formed at below the upper substrate; Mould comprises middle substrate in said.Said patrix and middle mould are provided with the groove that is used to form the microneedle array pedestal.Wherein also comprise counterdie.Said counterdie comprise infrabasal plate be arranged on this above infrabasal plate with at least one counterdie boss of its one, have the counterdie inclined plane that at least one is used to form micropin inclination lower surface on this counterdie boss.Substrate is provided with mould through hole in several identical with counterdie boss on the said counterdie of quantity in said.Be formed with the hole that at least one is used to define the micropin outer wall jointly between the middle mould through-hole wall of substrate and the counterdie boss in said.During matched moulds, in the corresponding middle mould through hole of mould, each core rod of said patrix inserted in the corresponding said hole, and the counterdie inclined plane contact matching of core rod bottom and said counterdie boss during each counterdie boss on the said counterdie stretched into respectively.
The quantity of mould through hole is one on the said middle substrate, and middle substrate bottom surface shape and infrabasal plate end face shape are complementary; In be provided with the middle mould cylinder with middle substrate one in the middle mould through hole of substrate, bottom shape of mould cylinder and counterdie boss end face shape match in this.Between middle mould cylinder and middle substrate, be provided with several peripheral through holes.The part that is positioned at each peripheral through hole below in the middle mould through-hole wall is provided with a notch that is connected smoothly with peripheral through hole separately, the said hole of common formation, corresponding counterdie inclined plane on each peripheral through hole, the notch that is positioned at peripheral through hole below and the counterdie boss.The lower surface of said core rod is the inclined-plane, the counterdie inclined plane contact matching of this inclined-plane and counterdie boss.
The quantity of mould through hole is one on the said middle substrate, and mould through hole circumferencial direction was provided with the notch of several openings towards middle mould through hole centrage during middle substrate upper edge was said, and each notch surrounds said hole jointly with the counterdie inclined plane of corresponding counterdie boss.The lower surface of said core rod is the inclined-plane, the counterdie inclined plane contact matching of this inclined-plane and counterdie boss.
Have the counterdie cylinder with its one above the said counterdie boss, the counterdie cylinder be provided with middle substrate on the notch that docks of notch, the notch on the counterdie cylinder and corresponding in notch and the counterdie inclined plane of counterdie boss of substrate surround said hole.
The quantity of middle mould through hole is one on the said middle substrate, and the bottom of said middle mould through hole is provided with and crossing acutangulate middle mould inclined plane, the counterdie inclined plane of corresponding counterdie boss.The lower surface of said core rod is the inclined-plane, the counterdie inclined plane contact matching of this inclined-plane and counterdie boss.
The quantity of middle mould through hole is one on the said middle substrate, and the bottom of said middle mould through hole is provided with and crossing acutangulate middle mould inclined plane, the counterdie inclined plane of corresponding counterdie boss.The lower surface of said core rod is and the vertical horizontal plane of said core rod centrage that the both sides, bottom of core rod have an inclined-plane that reaches middle mould inclined plane contact matching respectively with the counterdie inclined plane of said counterdie boss separately.
In said the bottom of mould through hole have with the counterdie boss on the precision-fit inclined-plane that is used to improve closing precision of corresponding bottom, counterdie inclined plane coupling.
The quantity of mould through hole is a plurality of of relative symmetric arrangement in twos on the said middle substrate, has mould vertical plane at least one in the said middle mould through-hole wall, has a notch in each on the mould vertical plane.The notch and the counterdie inclined plane of mould vertical plane surround said hole in said.The lower surface of said core rod is the inclined-plane with counterdie inclined plane contact matching.
The opposing one side in mould inclined plane, said counterdie boss up and down has the counterdie vertical plane, has a notch on each counterdie vertical plane.The face relative with middle mould vertical plane is middle mould inclined plane in the said middle mould through-hole wall.Form said hole between the notch of said counterdie vertical plane and the middle mould inclined plane.Also be provided with below the said patrix and extend in these holes and several core rods of lower surface and middle mould inclined plane contact matching.
Wherein each said in mould inclined plane be provided with 1 notch, this notch docks the said hole of formation with notch on the said counterdie vertical plane.Each said counterdie inclined plane is provided with 1 notch, this notch with said in notch on the mould vertical plane dock the said hole of formation.
The centrage that the central authorities of said middle substrate are provided with substrate in a V-shaped groove or the edge is provided with several V-shaped grooves.Establish on two opposing sidewalls of each V-shaped groove and respectively be provided with a notch, these two notches form the hole; The lower surface of stretching into the core rod in this hole in the cope match-plate pattern is and the vertical horizontal plane of its centrage that the both sides, bottom of this core rod are respectively equipped with the inclined-plane with this V-shaped groove contact matching.
Template is provided with several and the middle mould projection of said middle template one in said, and the mould projection has two opposing vertical planes in each, is connected with middle mould inclined plane with middle mould vertical plane respectively, is respectively equipped with notch on two vertical planes of middle mould projection.Be provided with above the said counterdie boss and said counterdie boss one and the counterdie projection identical with middle mould bump height; Each counterdie projection has two opposing vertical planes; Be connected with the counterdie inclined plane with the counterdie vertical plane respectively, be respectively equipped with notch on two vertical planes of counterdie projection.Notch butt joint on notch on the vertical plane of counterdie projection and the corresponding middle mould projection.
The opposing one side in mould inclined plane, said counterdie boss up and down has the counterdie vertical plane.The quantity of mould through hole is a plurality of of relative symmetric arrangement in twos on the said middle substrate.The middle mould vertical plane that has at least two positioned opposite in the mould through-hole wall in said has notch on the mould vertical plane in one of them, mould vertical plane and said counterdie vertical plane contact matching in another.Notch during each is said on the mould vertical plane surrounds said hole jointly with corresponding counterdie inclined plane.
The position of center line that the middle position of said middle substrate is provided with substrate in a center through hole or the edge is provided with several center through hole.Each center through hole has a middle mould vertical plane and middle mould inclined plane of positioned opposite, and middle mould inclined plane is provided with notch.Said lower bolster is provided with the counterdie central boss that can extend into said center through hole; This counterdie central boss have one with the counterdie vertical plane of the middle mould vertical plane contact matching of said center through hole and one with said in the mould inclined plane intersect acutangulate counterdie inclined plane; This counterdie inclined plane is provided with notch, surrounds the hole with notch on the middle mould inclined plane.The lower surface of stretching into the core rod in this hole in the said cope match-plate pattern is and the vertical horizontal plane of its centrage that these both sides, core rod bottom are respectively equipped with the inclined-plane with said counterdie inclined plane and middle mould inclined plane contact matching.
Wherein the mould through hole middle mould vertical plane top side is provided with the shoulder with middle template one in each is said, and several said shoulders are symmetric arrangement relatively in twos.Each shoulder has shoulder bottom surface and shoulder vertical plane, and the shoulder vertical plane is provided with notch.During matched moulds, this shoulder bottom surface and counterdie boss end face contact matching; The counterdie inclined plane of shoulder vertical plane and counterdie boss is connected smoothly; Notch on notch on the shoulder vertical plane and the relative middle mould vertical plane and corresponding counterdie inclined plane surround the hole.Middle template top between said center through hole and the middle mould through hole that is adjacent is provided with the boss with its one; This boss has two boss vertical planes of opposing layout; One of them boss vertical plane and middle mould inclined plane are connected smoothly, and another boss vertical plane is connected with the sidewall of corresponding middle mould through hole, is equipped with notch on two boss vertical planes; During matched moulds these two notches respectively with corresponding shoulder vertical plane on notch butt joint is connected the formation hole.
In said the middle mould vertical plane bottom of mould through hole have with the counterdie boss on the precision-fit inclined-plane that is used to improve closing precision of corresponding bottom, counterdie inclined plane coupling.
In said bottom, mould inclined plane have with the counterdie boss on the precision-fit vertical plane that is used to improve closing precision of corresponding counterdie vertical plane bottom coupling.
The shape of cross section of said some core rods is one or more the combinations in circle, ellipse, rectangle, triangle or " ten " word flower shape.
The advantage and the good effect of microneedle array of the present invention are: among the present invention; Owing to have the inclined-plane that at least one favours the micropin centrage in each micropin bottom; The outlet of micro hole is positioned at least one inclined-plane, so just can form spike at the outlet end of micropin.During use, the area of spike and contact skin is smaller, and under the effect of identical power, pressure is big, so the microneedle array that uses the micropin with spike of the present invention is very laborsaving, easy to use when skin puncture.Mould among the present invention is three board molds, comprises patrix, middle mould and counterdie, which is provided with the structure of the parts such as pedestal, needle body, spike part and micro hole that are used to form microneedle array, can produce the microneedle array with spike and micro hole.The manufacturing approach of microneedle array of the present invention is to use three board mold injection molding techniques of the present invention, because knockout course is a proceed step by step, has reduced ejection resistance greatly, so can easily produce the empty micropin array with spike.Simultaneously, because mould is reusable, so can produce in batches, this helps reducing significantly the production cost of microneedle array, thereby reduces the price of microneedle array significantly, helps the universal use of microneedle array.
With reference to the accompanying drawing description of a preferred embodiment, above-mentioned and other purpose of the present invention, feature and advantage will be more obvious through following.
Description of drawings
Fig. 1 is the structural representation of the microneedle array of the first embodiment of the present invention;
Figure 1A is along first kind of profile of A-A among Fig. 1;
Figure 1B is along the second refreshing profile of A-A among Fig. 1;
Fig. 1 C is along the third profile of A-A among Fig. 1;
Fig. 1 D is along the 4th kind of profile of A-A among Fig. 1;
Fig. 2 is the structural representation of the microneedle array of the second embodiment of the present invention;
Fig. 3 is the structural representation of the microneedle array of the third embodiment of the present invention;
Fig. 4 representes the structural representation of the microneedle array of the fourth embodiment of the present invention;
Fig. 4 A is along first kind of profile of B-B among Fig. 4;
Fig. 4 B is along second kind of profile of B-B among Fig. 4;
Fig. 4 C is along the third profile of B-B among Fig. 4;
Fig. 4 D is along the 4th kind of profile of B-B among Fig. 4;
Structural representation when Fig. 5 A representes three board mold matched moulds of the first embodiment of the present invention, the state before the injection fused raw material;
Structural representation when Fig. 5 B representes three board mold matched moulds of the first embodiment of the present invention, the state behind the injection fused raw material;
Fig. 5 C representes to use three board molds of the present invention to make the structural representation of the first step of the demoulding in the microneedle array process;
Fig. 5 D representes to use three board molds of the present invention to make the structural representation of second step of the demoulding in the microneedle array process;
Fig. 5 E representes to use three board molds of the present invention to make the structural representation of the third step of the demoulding in the microneedle array process;
Structural representation when Fig. 6 A representes three board mold matched moulds of the second embodiment of the present invention;
Fig. 6 B representes the decomposition texture sketch map of three board molds of the second embodiment of the present invention;
Structural representation when Fig. 7 representes three board mold matched moulds of the third embodiment of the present invention;
Structural representation when Fig. 8 representes three board mold matched moulds of the fourth embodiment of the present invention;
Structural representation when Fig. 9 A is three board mold matched moulds of the fifth embodiment of the present invention;
Fig. 9 B is the decomposition texture sketch map of three board molds of the fifth embodiment of the present invention;
Fig. 9 C is along first kind of profile of D-D among Fig. 9 A;
Fig. 9 D is along second kind of profile of D-D among Fig. 9 A;
Fig. 9 E is along the third profile of D-D among Fig. 9 A;
Structural representation when Figure 10 A is three board mold matched moulds of the sixth embodiment of the present invention;
Figure 10 B is the decomposition texture sketch map of three board molds of the sixth embodiment of the present invention;
Structural representation when Figure 11 A is three board mold matched moulds of the seventh embodiment of the present invention;
Figure 11 B is the decomposition texture sketch map of three board molds of the seventh embodiment of the present invention;
Figure 11 C is along first kind of cutaway view of C-C among Figure 11 A;
Figure 11 D is along second kind of cutaway view of C-C among Figure 11 A;
Figure 11 E is along the third cutaway view of C-C among Figure 11 A.
The specific embodiment
To describe specific embodiment of the present invention in detail below.Should be noted that the embodiments described herein only is used to illustrate, be not limited to the present invention.
Shown in Fig. 1, Figure 1A, Figure 1B, Fig. 1 C and Fig. 1 D; The micropin quantity that the microneedle array of first embodiment of the invention comprises is fewer, and its structure comprises pedestal 100 and is centrosymmetric with pedestal 100 integrated several arranges or axial symmetry is arranged micropin 101.Wherein has the liquid storage cylinder 102 that is used to store medicinal liquid or interstitial fluid in the pedestal 100.Has the micro hole 103 that communicates with liquid storage cylinder 102 in the micropin 101.Micropin 101 comprises and pedestal 100 integrated needle body parts 105 and spike part 104.Wherein the end face of spike part 104 is the inclined-plane 107 in an acute angle with the centrage of micropin 101, and the bottom on this inclined-plane 107 is the spike 106 of spike part 104.The length of micropin is the 50-1200 micron, is specifically confirmed by the function (like administration or sampling etc.) and the puncture position skin thickness of micropin.
In addition, the micropin in the present embodiment also can include only spike part 104, and does not comprise needle body part 105.The length of micropin is shorter under this kind situation, is suitable for the thin position of skin, perhaps administration, use when depth selection is more shallow.
In the present embodiment, the shape of pedestal 100 can be rectangle (seeing Figure 1A, Figure 1B) or circle (seeing Fig. 1 C, Fig. 1 D).The cross sectional shape of micropin 101 can be circular (seeing Figure 1B, Fig. 1 D), ellipse or rectangle (seeing Figure 1A, Fig. 1 C).The shape of cross section of micro hole 103 is perhaps " ten " word flower shapes (seeing Fig. 4 A) of circular (not shown), ellipse (seeing Figure 1A, Figure 1B, Fig. 1 C, Fig. 1 D), rectangle, triangle (not shown).In a microneedle array, the shape of cross section of several micro holes 103 also can be the combination of above-mentioned multiple shape.The central lines of the centrage of micro hole 103 and micropin 101 also can depart from micro hole 103 position of center line.Exit at micro hole 103 can be formed with the thin film (not shown), can be used for preventing skin puncture medicinal liquid seepage before, and after puncture, thin film can destroy through several different methods, for example pressure, vibration, electric current or chemical reaction etc.
In the present embodiment, microneedle array is processed through injection molding technique by plastics, composite, pottery or metal material, and cost of material is low, and manufacturing process is simple.And because micropin has spike part 104, spike part 104 has spike 106, and is laborsaving especially during transdermal.
As shown in Figure 2, in the microneedle array of the second embodiment of the present invention, the bottom of each micropin 101 has two inclined-planes 107, these two inclined-plane 107 positioned opposite, and in an acute angle with the centrage of micropin 101 respectively.These two inclined-planes 107 intersect at the internal face of micropin 101, form spike 106 at this place.Like this, spike 106 can be formed at or near the centrage of micropin 101, micropin is stressed more even during use.Among this embodiment; In several micropins 101 of microneedle array, can be that all micropins 101 all have two inclined-planes 107, also a part of micropin has two inclined-planes 107; And the microneedle configuration of another part micropin in embodiment one only has an inclined-plane 107.Other structures of the microneedle array of present embodiment are identical with embodiment one, repeat no more at this.
As shown in Figure 3, in the microneedle array of the third embodiment of the present invention, micro hole 103 is a blind hole, and the bottom of micropin 101 has two inclined-planes 107, and these two inclined-planes 107 intersect at the below of micro hole 103.Be formed with two outlet 110 symmetric arrangement on 110, two inclined-planes 107 of 1 outlet that is communicated with micro hole 103 on each inclined-plane 107.The quantity of outlet 110 is not limited to two, also can be 3,4 of symmetric arrangement.The stressed strength ratio of this kind micropin is better.Other structures of the microneedle array of present embodiment are identical with embodiment one, repeat no more at this.
Shown in Fig. 4, Fig. 4 A, Fig. 4 B, Fig. 4 C and Fig. 4 D, the micropin quantity that the microneedle array of the fourth embodiment of the present invention comprises is many, several micropins layout that is centrosymmetric.It comprises the micropin of two kinds of structures: a kind of micropin only forms spike part 104 by an inclined-plane, and spike is positioned at a side of micropin; Another kind is positioned at the middle position of pedestal or is positioned on the centrage of pedestal, and it forms spike part 104 by two inclined-planes, and spike is positioned at or near the position of center line of micropin.Shown in Fig. 4 A, Fig. 4 B, several micropins are arranged to circular array, and the spike part 104 that wherein is positioned at the micropin at pedestal 100 centers is formed by two inclined-planes, and its micro hole is " ten " word flower shape; The spike part 104 of other micropin is formed by an inclined-plane, the micro hole ovalize.The cross sectional shape of micropin can be rectangle (seeing Fig. 4 A), also can be approximate hexagon (seeing Fig. 4 B), can certainly be other shapes such as triangle, ellipse, circle.Shown in Fig. 4 C, Fig. 4 D; Several micropins are arranged to rectangular array, and the spike part 104 that is positioned at the string micropin of pedestal 100 centrages is formed by two inclined-planes, and micro hole is " ten " word flower shape; The spike part of other micropin is formed the micro hole ovalize by an inclined-plane.The cross sectional shape of micropin can be rectangle or approximate hexagon, also can be other shapes such as triangle, ellipse, circle.Other structures of the microneedle array of present embodiment are identical with first embodiment, repeat no more at this.
Mould of the present invention is three board molds, can make above-mentioned microneedle array with spike part easily.
Shown in Fig. 5 A, Fig. 5 B, Fig. 5 C, Fig. 5 D and Fig. 5 E, three board mold structures of the first embodiment of the present invention comprise: patrix 1, middle mould 2, counterdie 3.Wherein:
Counterdie 3 comprises infrabasal plate 30 and is arranged on above the infrabasal plate 30 and its one counterdie boss that this counterdie boss is a frustum 31, and the side of frustum 31 has several counterdie inclined planes, is provided with the counterdie cylinder 32 with its one above the frustum 31.Wherein the inclined-plane of frustum 31 is used to form the lower surface of the inclination of micropin, and the height of counterdie cylinder 32 equals the length of the needle body part 105 of micropin.If make the micropin that only has the spike part and do not have the needle body part, also this counterdie cylinder 32 can be set.
Substrate 20 during middle mould 2 comprises, middle position of substrate 20 has a straight-cylindrical middle mould through hole 21 in this, and bottom of mould through hole 21 has the precision-fit inclined-plane 22 that is used to improve closing precision in this.The circumferencial direction of mould through hole 21 evenly is provided with the notch of several opening directions towards middle mould through hole 21 centrages in middle substrate 20 upper edges; Each notch surrounds a top end opening jointly with the frustum 31 and the cylinder 32 of counterdie 3; The lower surface is the hole 4 on inclined-plane, and this hole 4 is used to form the micropin in the microneedle array.The upper end of the middle mould through hole 21 of middle mould 2 along the circumferential direction is provided with down annular groove 24, and this time annular groove 24 is communicated with hole 4.
Patrix 1 comprises upper substrate 10, below upper substrate 10, is formed with the identical some core rods 11 of notch quantity on quantity and the middle mould 2, and the lower surface of core rod 11 is the inclined-plane.Below the upper substrate 10 several core rod 11 outsides along the circumferential direction be provided with said in the last annular groove 12 that aligns mutually of following annular groove 24 on the mould 2.
When middle mould 2 and counterdie 3 matched moulds, the frustum 31 of counterdie 3 is arranged in the mould through hole 21 of mould 2, and the upper surface contact matching of the lower surface of middle substrate 20 and infrabasal plate 30 forms die joint 51.The precision-fit inclined-plane 22 of the bottom of the middle mould through hole 21 of middle substrate 20 and the frustum 31 outer surface contact matching of infrabasal plate 30 form die joint 52.
When patrix 1 and middle mould 2, counterdie 3 matched moulds, some core rods 11 insert in the corresponding holes 4, and the inclined-plane contact matching of the frustum 31 of the inclined-plane of its lower end and counterdie 3 forms die joint 53.Has the space between core rod 11 and hole 4 sidewalls.The upper surface of middle substrate 20 and the lower surface contact matching of upper substrate 10 form die joint 54.Following annular groove 24 on the middle substrate 20 aligns with the last annular groove 12 on the cope match-plate pattern 10 mutually, is used to form the part of the pedestal of microneedle array.Have space 5 between the interior zone that is surrounded by several core rods 11 on the cope match-plate pattern 1 and counterdie cylinder 32 upper surfaces of infrabasal plate 30, this space 5 is communicated with hole 4, is used to form another part of the pedestal of microneedle array.
Among this first embodiment, during the notch that is used to form the hole 4 of micropin only is formed on the circle wall of the middle mould through hole 21 of mould 2.This hole 4 also can be formed by middle mould and counterdie jointly; At this moment; Except on middle mould, offering the notch; Also will be on the counterdie cylinder 32 of counterdie 3 and the part that aligns of the notch with middle mould 2 of frustum 31 also offer notch, be opened in like this on the counterdie notch be opened in notch on the mould dock and can form the hole jointly.
In the present embodiment, the shape of the middle mould through hole 21 on the middle mould 2 is that frustum 31 shapes with counterdie 3 are complementary.For example, when frustum 31 was terrace with edge, middle mould through hole 21 was polygonal hole, and the limit number of mould through hole is identical with the rib number of terrace with edge in the polygon; When frustum 31 was round platform, middle mould through hole 21 was a circular port.See Figure 1A-Fig. 1 D, if make the microneedle array shown in Figure 1A, Fig. 1 C, then the frustum 31 of counterdie 3 is a truncated rectangular pyramids, and the middle mould through hole of middle mould 2 is a rectangular opening; If make the microneedle array shown in Figure 1B, Fig. 1 D, then the frustum 31 of counterdie 3 is a round platform, and the middle mould through hole of middle mould 2 is a circular hole.
In three board molds of present embodiment, injection port can be set on patrix, being provided with of this injection port can be identical with existing two board molds, repeats no more here.
Shown in Fig. 5 B, Fig. 5 C, Fig. 5 D and Fig. 5 E, use the method for the three board molds manufacturing microneedle array of the first embodiment of the present invention to comprise the steps:
(1) with the counterdie in three board molds 3, middle mould 2, patrix 1 matched moulds in order.
(2) fused raw materials such as the moldable plastics of injection, composite, pottery or metal material in mould.
(3) said three board molds of cooling and fused raw material wherein fully solidify until fused raw material.
(4) the substep demoulding: at first, along parting surface 51,52,53 therefrom break away from the mould 2 with counterdie 3.The lower surface of several micropins in the microneedle array of molding breaks away from the counterdie boss of counterdie 3, exposes the inclination lower surface of micropin, exposes a part of outside wall surface near the microneedle array centrage of micropin simultaneously.Then, middle mould 21 disengaging along die joint 54 from patrix.Mould 2 during other part outside wall surface of several micropins in the microneedle array of molding break away from the lower surface of pedestal, part side, thus complete micropin and part pedestal exposed.At last, the microneedle array with molding spins off from patrix with mould nail or other auxiliary vibrating devices again, thereby whole microneedle array and micro hole are completely exposed.In above-mentioned knockout course, can use vibrating device, help reducing ejection resistance.
In the method for the present invention, because knockout course divides two stages to carry out, promptly counterdie is thrown off with middle mould earlier, and middle mould is thrown off with patrix again, has so just reduced ejection resistance significantly, thereby can easily produce the spike part of micropin.Simultaneously, because mould can easily be realized large-scale mass production, so the microneedle array of the injection molding technique manufacturing of use of the present invention three board molds, its manufacturing cost reduces significantly.
Fig. 6 A, Fig. 6 B represent three board mold structures of the second embodiment of the present invention.Wherein:
Counterdie 3 comprises infrabasal plate 30 and is arranged on above the infrabasal plate 30 and the frustum 31 of its one.
In mould 2 comprise in substrate 20, be provided with the middle mould cylinder 33 with middle substrate 20 one in this in the middle mould through hole 21 of substrate 20, end face shape of the bottom shape of mould cylinder 33 and frustum 31 matches in this.The bottom shape of middle substrate 20 and the end face shape of counterdie 3 are complementary.Middle substrate 20 central upper are provided with drop-center 201, and this drop-center 201 is used to form the part pedestal of microneedle array.Between middle mould cylinder 33 and middle substrate 20, be provided with several peripheral through holes; The part that is positioned at each peripheral through hole below in middle mould through hole 21 walls respectively is provided with a notch that is connected smoothly with peripheral through hole, and each peripheral through hole, the notch that is positioned at peripheral through hole below and the inclined-plane of frustum 31 form hole 4 jointly.Hole 4 is communicated with drop-center 201, is used to form the micropin in the microneedle array.
In three board molds of this second embodiment, the structure of other parts that counterdie 3 and middle mould 2 are not stated and the structure of patrix 1 are identical with embodiment one, repeat no more at this.
The method that three board molds of the use second embodiment of the present invention are made microneedle array is identical with the method described in the embodiment one; Comprise matched moulds, injection, cooling, demoulding step; Knockout course also carries out stage by stage; Counterdie 3 is therefrom broken away from the mould 2, and mould 2 breaks away from from patrix 1 in making again, and the microneedle array with molding comes from patrix 1 disengaging at last.No longer be described in detail at this.
Fig. 7 representes three board mold structures of the third embodiment of the present invention.Three board molds of the 3rd embodiment are compared difference with first embodiment and only are: in several notches in being formed on the mould 2, in the bottom of each notch, promptly the end of contiguous counterdie has one and the acutangulate middle mould inclined plane 6 of notch centrage.Should intersect with the counterdie inclined plane of the frustum 31 of counterdie 3 on middle mould inclined plane 6, and the angle of the two is an acute angle.Bottom on the middle mould inclined plane 6 of middle mould through hole has the precision-fit inclined-plane 22 that is used to improve closing precision.This kind mould can produce the micropin that spike is positioned at micropin position of center line or contiguous position of center line.Use three board molds of this embodiment can produce microneedle array as shown in Figure 2.
In the three board mold structures of the 3rd embodiment, other structures do not stated in the middle mould and the structure of upper die and lower die are identical with three board molds of first embodiment, repeat no more at this.
The method that three board molds of the use third embodiment of the present invention are made microneedle array is identical with the method described in the embodiment one, repeats no more at this.
Fig. 8 representes three board mold structures of the fourth embodiment of the present invention.Three board molds of the 4th embodiment are compared difference with the 3rd embodiment and only are: the lower surface that is formed at the core rod 11 on the patrix 1 is and the vertical horizontal plane 7 of core rod 11 centrages; Rather than the inclined-plane, and be provided with a lead angle 113 that is complementary with counterdie inclined plane and middle mould inclined plane 6 separately in the two opposite sides of core rod 11 bottoms.The sectional area of two lead angles 113 is identical.Can change the size of its sectional area through the size that changes lead angle 113 when making in addition, and then change flow rate of liquid when using.During matched moulds, the lead angle 113 of core rod 11 lower ends respectively with counterdie inclined plane and middle mould inclined plane 6 contact matching.Use three board molds of the 4th embodiment can produce microneedle array as shown in Figure 3.
In the three board mold structures of the 3rd embodiment, the structure of other structures of patrix and middle mould, counterdie is identical with three board molds of the 3rd embodiment, repeats no more at this.
The method that three board molds of the use fourth embodiment of the present invention are made microneedle array is identical with the method described in the embodiment one, repeats no more at this.
Fig. 9 A, Fig. 9 B, Fig. 9 C, Fig. 9 D and Fig. 9 E represent three board mold structures of the fifth embodiment of the present invention.
Shown in Fig. 9 A, Fig. 9 B, three board mold structures of the fifth embodiment of the present invention comprise: patrix 1, middle mould 2 and counterdie 3.Wherein:
Counterdie 3 comprises infrabasal plate 30 and is arranged on above the infrabasal plate 30 in twos several counterdie boss 34 of symmetric arrangement relatively.Have at least one counterdie inclined plane 342 on each counterdie boss 34, on each counterdie inclined plane 342 1 notch can be set; Each 342 opposing side, mould inclined plane, counterdie boss 34 up and down can be a counterdie vertical plane 341, also notch can be set on the counterdie vertical plane 341.
Substrate 20 during middle mould 2 comprises; Should in substrate 20 be provided with in twos mould through hole 28 in several of symmetric arrangement relatively; Mould through hole 28 is corresponding with some counterdie boss 34 positions on the infrabasal plate 30 in these several, and the height of middle mould through hole 28 equates with the height of counterdie boss 34.In middle substrate 20 in mould through hole 28 above be provided with the drop-center 210 that communicates with middle mould through hole 28.Have mould vertical plane 281 at least one in each in the hole wall of mould through hole 28, mould vertical plane 281 can surround the hole with corresponding counterdie inclined plane in this.Can also be arranged to middle mould inclined plane 282 with middle mould vertical plane 281 relative faces in the hole wall of mould through hole 28 in each, middle mould inclined plane 282 can also surround the hole with the notch on the corresponding counterdie vertical plane 341.
The middle position of middle substrate 20 has one and perhaps along an one of which centrage several " V " shape grooves 26 is set, and has two notches that align on two relative walls of " V " shape groove 26, and these two notches can surround the hole.In order to increase closing precision; Be formed with the precision-fit inclined-plane 283 with counterdie inclined plane 342 contact matching in middle mould vertical plane 281 bottoms of middle substrate 20, be formed with precision-fit vertical plane 289 in 282 bottoms, middle mould inclined plane with counterdie vertical plane 341 bottom contact matching.
Referring to Fig. 9 A, Fig. 9 B and Fig. 9 C, the horizontal cross-section that is positioned at the counterdie boss 34 on two vertical center lines of infrabasal plate is approximate ellipsoidal (seeing Fig. 9 C), vertical section at right angles trapezoidal (seeing Fig. 9 B).The right angle waist of the counterdie boss 34 of right-angled trapezium shape is a counterdie vertical plane 341, and tiltedly waist is counterdie inclined plane 342.Be respectively equipped with an arc-shaped slot that opening is outside on counterdie vertical plane 341 and the counterdie inclined plane 342.A face that is arranged in the relative wall of two mould through holes 28 on the centrage on the middle substrate 20 is a mould vertical plane 281, and another face is middle mould inclined plane 282.The bottom of middle mould vertical plane 281 connects precision-fit inclined-plane 283, and the bottom on middle mould inclined plane 282 connects precision-fit vertical plane 289.Be respectively equipped with arc-shaped slot on middle mould vertical plane 281 and the middle mould inclined plane 282.Arc-shaped slot on the middle mould inclined plane 282 docks with the arc-shaped slot of corresponding counterdie vertical plane 341; In notch on the mould vertical plane 281 dock with notch on the counterdie inclined plane 342 accordingly; It is oval-shaped hole that the notch that docks in twos forms the horizontal cross-section respectively, is used to define the outer wall of micropin.The horizontal cross-section that is positioned at the counterdie boss 34 in 4 zones of being separated by two centrages is approximate " mountain " font (seeing Fig. 9 C), has inclined plane and vertical plane on the vertical direction.On each " mountain " font counterdie boss 6 arc-shaped slots are set.Correspondingly, the mould through hole 28 that is arranged in the substrate 20 in this zone also is " mountain " font, and its hole wall is provided with 6 arc-shaped slots.In these 6 arc-shaped slots; Being formed at the notch of mould vertical plane 281 docks with notch on the counterdie inclined plane 342; The notch on mould inclined plane 282 docks with the notch of counterdie vertical plane 341 in being formed at; It is oval-shaped hole that each notch to butt joint in twos forms the horizontal cross-section, is used to define the outer wall of micropin.The middle position of middle substrate 20 has " V " shape groove 26.
Referring to Fig. 9 A, Fig. 9 B and Fig. 9 D, the horizontal cross-section that is positioned at the counterdie boss 34 on two vertical center lines of infrabasal plate is surrounded by two straight lines and two camber lines, has inclined plane and vertical plane on the vertical direction.A face that is arranged in the opposite face of two mould through holes 28 on the centrage on the middle substrate 20 is a mould vertical plane 281, and another face is middle mould inclined plane 282.The bottom of middle mould vertical plane 281 connects precision-fit inclined-plane 283, and the bottom on middle mould inclined plane 282 connects precision-fit vertical plane 289.Be respectively equipped with rectangular notch on middle mould vertical plane 281 and the middle mould inclined plane 282, rectangular notch and counterdie vertical plane 341 on the middle mould inclined plane 282 join, and forming the horizontal cross-section is approximate rectangular hole.The horizontal cross-section that is positioned at the counterdie boss 34 in 4 zones of being separated by two centrages on the infrabasal plate 30 is approximate T shape (seeing Fig. 9 D); Be distributed with 6 rectangular notches on middle mould through hole 28 sidewalls in this zone, these 6 rectangular notches join with each face of T shape counterdie boss 34 respectively, and the horizontal cross-section that forms 6 is approximate rectangular hole.The middle position of middle substrate 20 has " V " shape groove 26.
Referring to Fig. 9 A, Fig. 9 B and Fig. 9 E, the counterdie boss 34 of infrabasal plate is rectangular, and several counterdie boss 34 are parallel and be arranged symmetrically in the both sides of infrabasal plate centrage.Middle side part at counterdie boss 34 evenly is provided with several rectangular notches, and middle mould through hole 28 sidewalls of this rectangular notch and middle mould 20 surround the hole.Two ends, the same side at counterdie boss 34 are provided with the dihedral notch, and this dihedral notch surrounds the hole with the dihedral notch of middle mould through hole 28 sidewalls that are arranged at middle mould.The middle mould through hole 28 of middle mould 20 is also rectangular; Except top dihedral notch; Also be provided with several rectangular notches, the counterdie vertical plane 341 of these rectangular notches and counterdie boss 34 or the notch on the counterdie inclined plane 342 join, and form rectangular hole, horizontal cross-section.Be furnished with several " V " shape grooves 26 on the centrage of middle substrate 20.
Patrix 1 comprises upper substrate 10, the identical some core rods 11 of number of cavities of mould 2 and counterdie 3 in below upper substrate 10, being formed with quantity and being formed at.The cross section ovalize or orthogonal core rod 11 structures of core rod 11 (seeing Fig. 9 E) and other positions that the string cross section that wherein is positioned at (seeing Fig. 9 B, Fig. 9 C, Fig. 9 D) of middle position or is positioned at centrage is " ten " word flower shape are identical with the mold insert structure shown in Fig. 8, repeat no more.Have the last annular groove 12 that communicates with the hole in the upper substrate 10, annular groove 12 also can suchly shown in Fig. 5 A be formed by patrix and middle mould jointly on this, and such die drawing resistance can be littler.
In addition; In the present embodiment, the middle mould projection of several and its one can also be set on middle template 20, the mould projection has two opposing vertical planes in each; Be connected with middle mould inclined plane with middle mould vertical plane respectively, be respectively equipped with notch on two vertical planes of middle mould projection.On the counterdie boss, be provided with and its one and the counterdie projection identical with middle mould bump height; Each counterdie projection has two opposing vertical planes; Be connected with the counterdie inclined plane with the counterdie vertical plane respectively, be respectively equipped with notch on two vertical planes of counterdie projection.Notch butt joint on notch on the vertical plane of counterdie projection and the corresponding middle mould projection.Micropin in the microneedle array that is gone out by the die production of this kind structure not only has the spike part, but also has the needle body part.
Referring to Fig. 9 A.When middle mould 2 and counterdie 3 matched moulds, each counterdie boss 34 is arranged in the corresponding mould through hole 28 of mould 2 separately, and the upper surface contact matching of the lower surface of middle substrate 20 and infrabasal plate 30 forms die joint 55.The precision-fit vertical plane 289 of middle substrate 20 and the counterdie vertical plane 341 bottom contact matching of counterdie boss 34 form die joint 56; The precision-fit inclined-plane 283 of middle substrate 20 and the counterdie inclined plane 342 bottom contact matching of counterdie boss 34 form die joint 59.
When patrix 1 and middle mould 2, counterdie 3 matched moulds, the upper surface contact matching of the lower surface of patrix 1 neighboring area and middle mould 2 neighboring areas forms die joint 54.Some core rods 11 insert in the corresponding hole.Wherein the bottom of " ten " word flower shape core rod and " V " shape groove 26 sidewall contact matching of middle substrate 20 form die joint 60; The inclined-plane of a part of core rod lower end in other core rods and counterdie inclined plane 342 contact matching of counterdie boss 34 form die joint 57; Middle mould inclined plane 282 contact matching of the inclined-plane of another part core rod lower end and middle mould 2 form die joint 58.Has the space between core rod 11 and the hole sidewall.Has the space between upper substrate 10 and the counterdie boss 34.
Figure 10 A, Figure 10 B represent three board mold structures of the sixth embodiment of the present invention.
Shown in Figure 10 A, Figure 10 B, three board mold structures of the sixth embodiment of the present invention comprise: patrix 1, middle mould 2 and counterdie 3.Wherein:
Counterdie 3 comprises infrabasal plate 30 and is arranged on the infrabasal plate 30 in twos several counterdie boss 34 of symmetric arrangement relatively.Have a counterdie vertical plane 341 and a counterdie inclined plane 342 on each counterdie boss 34 respectively.
In mould 2 comprise in substrate 20, substrate 20 is provided with in twos mould through hole 28 in several of symmetric arrangement relatively in this.The height of middle mould through hole 28 equates with the height of counterdie boss 34.Said in several mould through hole 28 be complementary with corresponding counterdie boss 34 on the infrabasal plate 30.Two relative vertical planes are middle mould vertical plane 281 in the hole wall of middle mould through hole 28; Wherein the counterdie inclined plane 342 relative middle mould vertical planes 281 with counterdie boss 34 are provided with notch; This notch surrounds the hole with corresponding counterdie inclined plane, and bottom of mould vertical plane 281 is connected with being used to of cooperating with counterdie vertical plane 341 and improves closing precision and be beneficial to the precision-fit inclined-plane 283 that reduces die drawing resistance in another.
In the present embodiment, can also a counterdie central boss 340 be set at infrabasal plate 30 middle positions and perhaps several counterdie central boss 340 be set along a centrage of infrabasal plate 30; Middle substrate 20 is provided with the straight tubular central through hole 29 that is complementary with counterdie central boss 340, and the height of center through hole 29 highly equates with counterdie central boss 340, and equates with the height of middle mould through hole 28.Center through hole 29 has a middle mould vertical plane 281, mould inclined plane 282 during the phase dorsal part of mould vertical plane 281 is provided with in this, and the bottom on middle mould inclined plane 282 is connected with the precision-fit inclined-plane 283 that is complementary with counterdie central boss 340 bottoms.Middle mould inclined plane 282 intersects acute angle with the counterdie inclined plane 342 of central boss 340; Be respectively equipped with notch on the middle mould inclined plane 282 that should intersect and the counterdie inclined plane 342 of central boss 340; These two notch butt joints connect during matched moulds, are used to form the needle body part of micropin.
Last mode structure shown in the structure of patrix 1 and Fig. 9 B is basic identical, repeats no more.
Referring to Figure 10 A.When middle mould 2 and counterdie 3 matched moulds, each counterdie boss 34 is arranged in the corresponding mould through hole 28 of mould 2 separately, and counterdie central boss 340 is arranged in the center through hole 29 of mould.Middle mould vertical plane 281 and counterdie vertical plane 341 contact matching.The lower surface of middle substrate 20 and the upper surface contact matching of infrabasal plate 30 form die joint 55.The precision-fit inclined-plane 283 of middle substrate 20 and the counterdie inclined plane 342 bottom contact matching of counterdie boss 34 form die joint 59.
When patrix 1 and middle mould 2, counterdie 3 matched moulds, the upper surface contact matching of the lower surface of patrix 1 neighboring area and middle mould 2 neighboring areas forms die joint 54.Some core rods 11 insert in the corresponding hole.The bottom of " ten " word flower shape core rod respectively with the middle mould inclined plane 282 of the center through hole of middle substrate 20 and counterdie inclined plane 342 contact matching of counterdie central boss 340, form die joint 60; Counterdie inclined plane 342 contact matching of the inclined-plane of other core rod lower ends and counterdie boss 34 form die joint 57.Has the space between core rod 11 and the hole sidewall.Has the space between the lower surface of upper substrate 10 and counterdie boss 34 end faces.
Three board molds of the 6th embodiment and the difference of the 5th embodiment have 2 points: the one, and the hole that is used to form micropin is completed on middle mould 2, and the counterdie inclined plane 342 of counterdie boss 34 only is used to form the inclined end face of micropin bottom; The 2nd, V-shaped groove is formed with center through hole 29 by central counterdie boss 340 jointly.And the hole that is used to form micropin among the 5th embodiment is to be formed jointly by the notch on middle mould 2 and the counterdie 3; V-shaped groove directly is formed on the middle mould 2.
Figure 11 A, Figure 11 B, Figure 11 C, Figure 11 D, Figure 11 E represent three board mold structures of the seventh embodiment of the present invention.
Three board mold structures of the seventh embodiment of the present invention comprise: patrix 1, middle mould 2 and counterdie 3.Wherein:
The structure of patrix 1 and counterdie 3 is identical with the three board mold structures of above-mentioned the 6th embodiment, repeats no more.
In mould 2 only be with middle mode structure difference among above-mentioned the 6th embodiment: mould vertical plane 281 top sides are provided with a shoulder 285 with middle template 20 one in one of them of mould through hole 28 in each, and this shoulder 285 has shoulder bottom surface and shoulder vertical plane 286.The relative in twos symmetric arrangement of several shoulders 285.Shoulder vertical plane 286 is provided with notch.When central mould 2 and counterdie 3 matched moulds, the end face contact matching of the bottom surface of this shoulder 285 and counterdie boss 34, shoulder vertical plane 286 is connected smoothly with counterdie inclined plane 342.Notch in another of notch on the shoulder vertical plane 286 and the middle mould through hole 28 relative with it on mould vertical plane 281 and corresponding counterdie inclined plane surround the hole, and this hole can be used to form the micropin with main part.
Middle substrate 20 tops between the center through hole 29 of middle mould 2 and adjacent with it middle mould through hole have the boss 288 with its one; This boss 288 has two boss vertical planes 287 of opposing layout; One of them boss vertical plane 287 is connected smoothly with middle mould inclined plane 282, and another boss vertical plane 287 is connected with a sidewall of adjacent middle mould through hole.Be equipped with notch on two boss vertical planes 287, respectively with corresponding shoulder 285 on the notch butt joint.The mould of present embodiment can be produced the micropin with main part.
Though described the present invention with reference to several exemplary embodiments, should be appreciated that used term is explanation and exemplary and nonrestrictive term.Because the present invention's practical implementation and do not break away from the spirit or the essence of invention in a variety of forms; So be to be understood that; The foregoing description is not limited to any aforesaid details; And should in enclose spirit that claim limited and scope, explain widely, therefore fall into whole variations and remodeling in claim or its equivalent scope and all should be the claim of enclosing and contain.

Claims (18)

1. mould of making microneedle array; Comprise patrix (1) and middle mould (2); Wherein said patrix (1) comprises upper substrate (10) and is formed at following several core rods (11) of upper substrate (10); Mould (2) comprises middle substrate (20) in said, and said patrix (1) and middle mould (2) are provided with the groove that is used to form the microneedle array pedestal; It is characterized in that also comprising counterdie (3); Said counterdie (3) comprises infrabasal plate (30) and is arranged on above this infrabasal plate (30) and at least one counterdie boss of its one to have the counterdie inclined plane that at least one is used to form micropin inclination lower surface on this counterdie boss; Substrate (20) is provided with mould through hole in several identical with counterdie boss on the said counterdie (3) of quantity in said, is formed with the hole that at least one is used to define the micropin outer wall jointly between the middle mould through-hole wall of said middle substrate (20) and the counterdie boss; During matched moulds; Each counterdie boss on the said counterdie (3) stretches into respectively in the corresponding middle mould through hole of middle mould (2); Each core rod (11) of said patrix (1) inserts in the corresponding said hole, and the counterdie inclined plane contact matching of core rod (11) bottom and said counterdie boss.
2. the mould of microneedle array as claimed in claim 1 is characterized in that, the quantity of mould through hole was one during said middle substrate (20) was gone up, and middle substrate (20) bottom shape and infrabasal plate end face shape are complementary; In be provided with the middle mould cylinder (33) with middle substrate (20) one in the middle mould through hole of substrate (20), bottom shape of mould cylinder (33) and counterdie boss end face shape match in this; Between middle mould cylinder (33) and middle substrate (20), be provided with several peripheral through holes; The part that is positioned at each peripheral through hole below in the middle mould through-hole wall is provided with a notch that is connected smoothly with peripheral through hole separately, the said hole of common formation, corresponding counterdie inclined plane on each peripheral through hole, the notch that is positioned at peripheral through hole below and the counterdie boss; The lower surface of said core rod (11) is the inclined-plane, the inclined-plane of this core rod (11) lower end and the counterdie inclined plane contact matching of counterdie boss.
3. the mould of microneedle array as claimed in claim 1; It is characterized in that; The quantity of mould through hole was one during substrate (20) was gone up in said; Mould through hole circumferencial direction was provided with the notch of several openings towards middle mould through hole centrage during middle substrate (20) upper edge was said, and each notch surrounds said hole jointly with the counterdie inclined plane of corresponding counterdie boss; The lower surface of said core rod (11) is the inclined-plane, the inclined-plane of this core rod (11) lower end and the counterdie inclined plane contact matching of counterdie boss.
4. the mould of microneedle array as claimed in claim 3; It is characterized in that; Has counterdie cylinder (32) above the said counterdie boss with its one; Counterdie cylinder (32) be provided with middle substrate (20) on the notch that docks of notch, the notch on the counterdie cylinder (32) and corresponding in notch and the counterdie inclined plane of counterdie boss of substrate (20) surround said hole.
5. the mould of microneedle array as claimed in claim 1; It is characterized in that; The quantity of the upward middle mould through hole of substrate (20) is one in said, and the bottom of said middle mould through hole is provided with and crossing acutangulate middle mould inclined plane (6), the counterdie inclined plane of corresponding counterdie boss; The lower surface of said core rod (11) is the inclined-plane, the inclined-plane of this core rod (11) lower end and the counterdie inclined plane contact matching of counterdie boss.
6. the mould of microneedle array as claimed in claim 1; It is characterized in that; The quantity of the upward middle mould through hole of substrate (20) is one in said, and the bottom of said middle mould through hole is provided with and crossing acutangulate middle mould inclined plane (6), the counterdie inclined plane of corresponding counterdie boss; The lower surface of said core rod (11) is and the vertical horizontal plane of said core rod (11) centrage (7) that the both sides, bottom of core rod (11) have an inclined-plane that reaches middle mould inclined plane contact matching respectively with the counterdie inclined plane of said counterdie boss separately.
7. like the mould of claim 2,3,4,5 or 6 described microneedle arrays, it is characterized in that, said in the bottom of mould through hole have with the counterdie boss on the precision-fit inclined-plane (22) that is used to improve closing precision of corresponding bottom, counterdie inclined plane coupling.
8. the mould of microneedle array as claimed in claim 1; It is characterized in that; The quantity of mould through hole was a plurality of of relative symmetric arrangement in twos during substrate (20) was gone up in said, had mould vertical plane (281) at least one in the said middle mould through-hole wall, had a notch in each on the mould vertical plane (281); Notch and counterdie inclined plane (342) of mould vertical plane (281) surround said hole in said, and the lower surface of said core rod (11) is the inclined-plane with counterdie inclined plane (342) contact matching.
9. the mould of microneedle array as claimed in claim 8 is characterized in that, the opposing one side in mould inclined planes, said counterdie boss (34) up and down (342) has counterdie vertical plane (341), has a notch on each counterdie vertical plane (341); The face relative with middle mould vertical plane (281) is middle mould inclined plane (282) in the said middle mould through-hole wall; Form said hole between the notch of said counterdie vertical plane (341) and the middle mould inclined plane (282), also be provided with below the said patrix (1) and extend in these holes and several core rods (11) of lower surface and middle mould inclined plane (282) contact matching.
10. the mould of microneedle array as claimed in claim 9 is characterized in that, mould inclined plane (282) was provided with 1 notch during each was said, and the notch in this on mould inclined plane (282) docks the said hole of formation with notch on the said counterdie vertical plane (341); Each said counterdie inclined plane (342) is provided with 1 notch, the notch on this counterdie inclined plane (342) with said in notch on the mould vertical plane (281) dock the said hole of formation.
11. mould like claim 8,9 or 10 described microneedle arrays; It is characterized in that; The centrage that the central authorities of said middle substrate (20) are provided with substrate (20) in a V-shaped groove (26) or the edge is provided with several V-shaped grooves (26); Establish on two opposing sidewalls of each V-shaped groove (26) and respectively be provided with a notch, two notches that are formed at two opposing sidewalls of said V-shaped groove (26) form said hole; The lower surface of stretching into the core rod in this said hole in the cope match-plate pattern (10) is and the vertical horizontal plane of its centrage that the both sides, bottom of this core rod are respectively equipped with the inclined-plane with this V-shaped groove (26) contact matching.
12. the mould of microneedle array as claimed in claim 11; It is characterized in that; Template (20) is provided with several and the middle mould projection of said middle template (20) one in said; The mould projection has two opposing vertical planes in each, is connected with middle mould inclined plane (282) with middle mould vertical plane (281) respectively, is respectively equipped with notch on two vertical planes of middle mould projection; Be provided with above the said counterdie boss (34) and said counterdie boss (34) one and the counterdie projection identical with middle mould bump height; Each counterdie projection has two opposing vertical planes; Be connected with counterdie inclined plane (342) with counterdie vertical plane (341) respectively, be respectively equipped with notch on two vertical planes of counterdie projection; Notch butt joint on notch on the vertical plane of counterdie projection and the corresponding middle mould projection.
13. the mould of microneedle array as claimed in claim 1; It is characterized in that; The opposing one side in mould inclined planes, said counterdie boss up and down (342) has counterdie vertical plane (341); The quantity of mould through hole was a plurality of of relative symmetric arrangement in twos during substrate (20) was gone up in said; The middle mould vertical plane (281) that has at least two positioned opposite in the mould through-hole wall in said has notch on the mould vertical plane (281) in one of them, mould vertical plane (281) and said counterdie vertical plane (341) contact matching in another; Notch during each is said on the mould vertical plane (281) surrounds said hole jointly with corresponding counterdie inclined plane (342).
14. the mould of microneedle array as claimed in claim 13; It is characterized in that; The position of center line that the middle position of said middle substrate (2) is provided with substrate (2) in a center through hole (29) or the edge is provided with several center through hole (29); Each center through hole (29) has a middle mould vertical plane (281) and a middle mould inclined plane (282) of positioned opposite, and middle mould inclined plane (282) is provided with notch; Said lower bolster (3) is provided with the counterdie central boss (340) that can extend into said center through hole (29); This counterdie central boss (340) have one with the counterdie vertical plane (341) of middle mould vertical plane (281) contact matching of said center through hole (29) and one with said in mould inclined plane (282) intersect acutangulate counterdie inclined plane (342); This counterdie inclined plane (342) is provided with notch, surrounds said hole with notch on the middle mould inclined plane (282); The lower surface of stretching into the core rod in this hole in the said cope match-plate pattern (10) is and the vertical horizontal plane of its centrage that these both sides, core rod bottom are respectively equipped with the inclined-plane with said counterdie inclined plane (342) and middle mould inclined plane (282) contact matching.
15. the mould of microneedle array as claimed in claim 14; It is characterized in that; The mould through hole middle mould vertical plane (281) top side is provided with the shoulder (285) with middle template (2) one in each is said; The relative in twos symmetric arrangement of several said shoulders (285), each shoulder (285) has shoulder bottom surface and shoulder vertical plane (286), and shoulder vertical plane (286) is provided with notch; During matched moulds; This shoulder bottom surface and counterdie boss end face contact matching; The counterdie inclined plane (342) of shoulder vertical plane (286) and counterdie boss (34) is connected smoothly, the notch on the notch on the shoulder vertical plane (286) and the relative middle mould vertical plane (281) and accordingly counterdie inclined plane (342) surround said hole; Middle template (20) top between said center through hole (29) and the middle mould through hole that is adjacent is provided with the boss (288) with its one; This boss (288) has two boss vertical planes (287) of opposing layout; One of them boss vertical plane (287) is connected smoothly with middle mould inclined plane (282); Another boss vertical plane (287) is connected with the sidewall of corresponding middle mould through hole; Be equipped with notch on two boss vertical planes (287), during matched moulds these two notches respectively with corresponding shoulder vertical plane (286) on notch butt joint be connected, form said hole.
16. the mould of microneedle array as claimed in claim 8; It is characterized in that, said in middle mould vertical plane (281) bottom of mould through hole have with the counterdie boss on the precision-fit inclined-plane (283) that is used to improve closing precision of corresponding bottom, counterdie inclined plane (342) coupling.
17. the mould of microneedle array as claimed in claim 9 is characterized in that, said in bottom, mould inclined plane (282) have with the counterdie boss on the precision-fit vertical plane (289) that is used to improve closing precision of corresponding counterdie vertical plane (341) bottom coupling.
18. the mould of microneedle array as claimed in claim 1 is characterized in that, the shape of cross section of said some core rods (11) is one or more the combination in circle, ellipse, rectangle, triangle or " ten " word flower shape.
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