CN101856538A - Microneedle array, die casting method for manufacturing microneedle array and die used by same - Google Patents

Abstract

The invention provides a microneedle array, a method for manufacturing the microneedle array and a mould used by the microneedle array. The microneedle array comprises a base and a plurality of microneedles integrally formed with the base. A liquid storage cavity is arranged in the base, and a micro-needle hole communicated with the liquid storage cavity is arranged in each micro-needle. The micro-needle array is made of plastic, composite material, ceramic or metal material through an injection molding process. Each microneedle has at least one bevel inclined to the centerline of the microneedle, and the exit of the microneedle hole is located on the at least one bevel, thus forming a peak portion at the exit end of the microneedle. The special die 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 micro-needles, and the upper die and the middle die are provided with grooves for forming bases. The microneedle array with the peak can be conveniently manufactured by using the three-plate mold. In the injection molding method, the demolding process is performed step by step, so the mold drawing resistance is small, and the manufacturing cost is low.

Description

Microneedle array, molding method for manufacturing the microneedle array, and mold used

technical field

The invention relates to a microneedle array with microneedle holes, a method for manufacturing the microneedle array and a special mold used in the method.

Background technique

The outermost skin layer of the human body, such as the stratum corneum, is the most beneficial biological barrier protection layer of the human body. The stratum corneum has excellent electrical insulation, which can effectively prevent external fluid from entering the subcutaneous tissue, and can also prevent the interstitial fluid from seeping out. At present, in the field of biomedicine, subcutaneous administration (that is, direct administration of medicinal liquid to the subcutaneous tissue below the stratum corneum) and collection of test samples from the subcutaneous interstitial fluid are becoming increasingly important for treating and diagnosing diseases. Both procedures require the use of needles or microneedle arrays that can penetrate the stratum corneum of the skin.

US Patent No. 6,471,903B2 discloses a plastic hollow microneedle array structure, which includes a base and several microneedles integrally formed with the base. Wherein the base has a liquid storage chamber for storing medicinal liquid or interstitial fluid. The microneedle is hollow, that is, it has a central microneedle hole communicating with the liquid storage cavity of the base. This microneedle with a microneedle hole has an inner wall surface and an outer wall surface, in order to reduce the resistance when penetrating the skin , the outer wall of the microneedle is made into a tapered shape, so that the front end of the microneedle is sharper, which saves effort when used. Such microneedle arrays can be fabricated by injection molding using a two-plate mold. However, because the outlet end face of the microneedle hole of this kind of microneedle is perpendicular to its center line, the resistance suffered when penetrating the skin is relatively large, especially when several microneedles form a microneedle array, the resistance suffered is even greater. up. Currently, there is an array of microneedles made of silicon material with tips. Because the material silicon of this kind of microneedle array is relatively expensive, this makes the cost of the microneedle array too high, and the microneedle array is a disposable medical product and cannot be reused. The practicability of the microneedle array of this kind of silicon material is poor. At the same time, the microneedle array of this silicon material is made by a photoetching process. The photoetching process is relatively complicated, and only a single product can be produced each time. It is difficult to achieve mass production, and the process cost is high.

Contents of the invention

The purpose of the present invention is to overcome the deficiencies of the above-mentioned prior art, and provide a microneedle array with low resistance and low cost when penetrating the skin;

Another object of the present invention is to provide a method for manufacturing the above-mentioned microneedle array;

The third object of the present invention is to provide a special mold used in the method of manufacturing the above-mentioned microneedle array.

To achieve the above object, the present invention adopts the following technical solutions:

The microneedle array of the present invention includes a base and several microneedles integrally formed with the base. A liquid storage chamber for storing medicinal liquid or interstitial fluid is provided in the base, and each microneedle has a microneedle hole in communication with the liquid storage chamber. Wherein the microneedle array is made of plastic, composite material, ceramic or metal material through injection molding process. Each of the microneedles has at least one slope inclined to the center line of the microneedle, the exit of the microneedle is located on at least one of the slopes, and the slopes on several microneedles are arranged centrally or axisymmetrically, This forms a peaked portion at the exit end of the microneedle.

The number of the inclined surface is one, and the inclined surface intersects with the outer wall of the microneedle to form a peak.

The number of the slopes is two, and the two slopes intersect on the inner wall of the microneedle to form a peak, and the outlet of the microneedle hole is located on one of the slopes.

There are two slopes intersecting below the microneedle holes, and there are two outlets of the microneedle holes, which are respectively located on the two slopes, and the two outlets are arranged symmetrically.

There is also a needle part between the base and the peak part.

The cross-sectional shapes of several of the micropinholes are one or a combination of circular, elliptical, rectangular, triangular or cross-shaped.

The cross-sectional shape of the microneedle is circular, oval or rectangular.

A thin film is formed at the exit of the micro pinhole.

The central line of the microneedle coincides with the central line of the microneedle or deviates from the central line of the microneedle.

The several microneedles are arranged in a circle, a rectangle, a circle array or a rectangle array.

The mold for manufacturing the microneedle array of the present invention includes an upper mold and a middle mold. Wherein the upper mold includes an upper base plate and several mold cores formed under the upper base plate; the middle mold includes a middle base plate. The upper mold and the middle mold are provided with grooves for forming the base of the microneedle array. It also includes the die. The lower mold includes a lower base plate and at least one lower mold boss integrally arranged on the lower base plate. The lower mold boss has at least one lower mold inclined surface for forming the inclined lower end surface of the microneedles. The middle base plate is provided with a number of through holes of the middle mold which are the same as the bosses of the lower mold on the lower mold. At least one cavity for defining the outer wall of the microneedle is jointly formed on the middle substrate or between the through-hole wall of the middle substrate and the boss of the lower mold. When closing the mold, each lower mold boss on the lower mold extends into the corresponding middle mold through hole of the middle mold respectively, and each mold core of the upper mold is inserted into the corresponding cavity, and the lower end of the mold core It contacts and cooperates with the inclined surface of the lower die of the boss of the lower die.

The number of the through hole of the middle mold on the middle base plate is one, and the shape of the bottom surface of the middle base plate matches the shape of the top surface of the lower base plate; The shape of the bottom surface of the cylinder coincides with the shape of the top surface of the boss of the lower die. Several peripheral through holes are arranged between the middle mold cylinder and the middle base plate. The part of the through hole wall of the middle die below each peripheral through hole is respectively provided with a notch smoothly transitioned to the peripheral through hole, and each peripheral through hole, the notch below the peripheral through hole and the corresponding corresponding groove on the boss of the lower die The inclined surfaces of the lower mold jointly form the cavity. The lower end surface of the mold core is an inclined surface, and the inclined surface is in contact with the inclined surface of the lower mold of the lower mold boss.

The number of the through hole of the middle mold on the middle base plate is one, and the middle base plate is provided with several notches with openings facing the center line of the through hole of the middle mold along the circumferential direction of the through hole of the middle mold, and each notch is connected with the corresponding lower mold through hole. The inclined surface of the lower mold of the mold boss jointly encloses the cavity. The lower end surface of the mold core is an inclined surface, and the inclined surface is in contact with the inclined surface of the lower mold of the lower mold boss.

There is a lower mold cylinder integrated with it on the lower mold boss, and the lower mold cylinder is provided with a notch docked with the notch on the middle base plate, and the notch on the lower mold cylinder is connected with the corresponding groove of the middle base plate. The mouth and the inclined surface of the lower mold boss of the lower mold surround the cavity.

There is one middle mold through hole on the middle base plate, and the lower end of the middle mold through hole is provided with a middle mold inclined surface that intersects with the lower mold inclined surface of the corresponding lower mold boss to form an acute angle. The lower end surface of the mold core is an inclined surface, and the inclined surface is in contact with the inclined surface of the lower mold of the lower mold boss.

There is one middle mold through hole on the middle base plate, and the lower end of the middle mold through hole is provided with a middle mold inclined surface that intersects with the lower mold inclined surface of the corresponding lower mold boss to form an acute angle. The lower end surface of the mold core is a horizontal plane perpendicular to its center line, and the two sides of the lower end of the mold core each have a slope that is in contact with the inclined surface of the lower mold and the inclined surface of the middle mold of the lower mold boss.

The lower end of the through hole of the middle mold or the lower end of the inclined surface of the middle mold has a precision matching inclined surface for improving the accuracy of mold clamping that matches the lower end of the corresponding lower mold inclined surface on the boss of the lower mold.

The number of the through-holes of the middle mold on the middle base plate is a plurality of pairs symmetrically arranged, and the wall of the through-hole of the middle mold has at least one vertical surface of the middle mold, and each vertical surface of the middle mold has a notch. The cavity is surrounded by the notch on the vertical surface of the middle mold and the inclined surface of the lower mold. The lower end surface of the mold core is an inclined surface that contacts and cooperates with the inclined surface of the lower mold.

The side opposite to the inclined surface of the lower die on the boss of the lower die has a vertical face of the lower die, and each vertical face of the lower die has a notch. The surface opposite to the vertical surface of the middle mold in the wall of the through hole of the middle mold is the inclined surface of the middle mold. A cavity is formed between the notch on the vertical surface of the lower mold and the inclined surface of the middle mold. There are also several mold cores protruding into these cavities below the upper mold, and the lower end surface is in contact with the inclined surface of the middle mold.

Wherein each of the inclined surfaces of the middle mold is provided with a notch, and the notch is docked with the notch on the vertical surface of the lower mold to form the cavity. Each inclined surface of the lower mold is provided with a notch, and the notch is docked with the notch on the vertical surface of the middle mold to form the cavity.

A V-shaped groove is arranged in the center of the middle base plate or several V-shaped grooves are arranged along a central line of the middle base plate. The two opposite side walls of each V-shaped groove are respectively provided with a notch, and the two notches form a cavity; the lower end surface of the mold core extending into the cavity in the upper template is perpendicular to its center line The two sides of the lower end of the mold core are respectively provided with inclined surfaces that are in contact with the V-shaped groove.

The middle template is provided with several middle mold projections integral with it, and each middle mold projection has two opposite vertical surfaces, which are respectively connected with the vertical surface of the middle mold and the inclined surface of the middle mold, and the middle mold convex Notches are respectively provided on the two vertical faces of the block. Described lower mold boss is provided with the lower mold projection that is integral with it and has the same height as middle mold projection, each lower mold projection has two opposite vertical surfaces, respectively with the lower mold vertical surface and the lower mold projection. The inclined surfaces of the molds are connected, and the two vertical surfaces of the convex blocks of the lower mold are respectively provided with notches. The notch on the vertical surface of the lower mold lug is docked with the notch on the corresponding middle mold lug.

The side opposite to the inclined surface of the lower die on the boss of the lower die has a vertical face of the lower die. The number of through-holes of the middle mold on the middle base plate is arranged symmetrically in pairs. The through-hole wall of the middle mold has at least two oppositely arranged vertical surfaces of the middle mold, one of which has a notch on the vertical surface of the middle mold, and the other vertical surface of the middle mold is in contact with the vertical surface of the lower mold. Each notch on the vertical surface of the middle mold and the corresponding inclined surface of the lower mold jointly enclose the cavity.

A central through hole is provided at the center of the middle base plate or several central through holes are provided along a central line of the middle base plate. Each central through hole has a vertical surface of the middle mold and an inclined surface of the middle mold arranged oppositely, and notches are arranged on the inclined surface of the middle mold. The lower template is provided with a lower mold central boss that can extend into the central through hole, and the lower mold central boss has a lower mold vertical surface that is in contact with the middle mold vertical surface of the central through hole and A lower mold inclined surface intersects with the inclined surface of the middle mold to form an acute angle, the inclined surface of the lower mold is provided with a notch, and forms a cavity with the notch on the inclined surface of the middle mold. The lower end surface of the mold core protruding into the cavity in the upper template is a horizontal plane perpendicular to its center line, and the two sides of the lower end of the mold core are respectively provided with the inclined surface of the lower mold and the inclined surface of the middle mold. inclined plane.

A shoulder integrated with the middle template is provided on the top side of a vertical surface of the middle mold through the through hole of each said middle mold, and several said shoulders are symmetrically arranged in pairs. Each shoulder has a shoulder bottom surface and a shoulder vertical surface, and the shoulder vertical surface is provided with a notch. When closing the mold, the bottom surface of the shoulder is in contact with the top surface of the boss of the lower mold; the vertical surface of the shoulder is smoothly connected with the inclined surface of the lower mold of the boss of the lower mold; the notch on the vertical surface of the shoulder is connected with the opposite middle The notch on the vertical surface of the mold and the corresponding inclined surface of the lower mold form a cavity. The top of the middle formwork between the central through hole and the through hole of the adjacent middle mold is provided with a boss integrated with it, and the boss has two vertical faces of the boss arranged opposite to each other, one of which is vertical surface is connected with the inclined surface of the middle mold in a smooth transition, and the other vertical surface of the boss is connected with the side wall of the corresponding through hole of the middle mold. There are notches on the vertical surfaces of the two bosses. When the mold is closed, the two grooves The openings are respectively butted and connected with the notches on the corresponding vertical surface of the shoulder to form a cavity.

The lower end of the vertical surface of the middle mold in the through hole of the middle mold has a precision matching inclined surface for improving the accuracy of mold clamping, which is matched with the lower end of the inclined surface of the lower mold on the boss of the lower mold.

The lower end of the inclined surface of the middle mold has a precision fit vertical surface for improving mold clamping precision that matches the lower end of the corresponding lower mold vertical surface on the lower mold boss.

The cross-sectional shape of the several mold cores is one or a combination of circular, elliptical, rectangular, triangular or cross-shaped.

The method for manufacturing the microneedle array of the present invention comprises the following steps:

(1) Provide a three-plate mold including lower mold, middle mold and upper mold;

(2) Close the lower mold, middle mold and upper mold in order;

(3) Injecting moldable molten raw materials into the mold;

(4) cooling the three-plate mold and the molten raw material therein until the molten raw material is fully solidified;

(5) Step-by-step demoulding: first separate the lower mold from the middle mold along the separation surface with the middle mold; then separate the middle mold from the upper mold along the separation surface with the upper mold; finally separate the microneedle array from the upper mold Separation on the mold.

The advantages and positive effects of the microneedle array of the present invention are: in the present invention, since the lower end of each microneedle has at least one slope inclined to the center line of the microneedle, the outlet of the microneedle hole is located on at least one slope, so that Spikes may be formed at the exit ends of the microneedles. When in use, the contact area between the peaks and the skin is relatively small, and under the same force, the pressure is strong, so the microneedle array with the peaks of the present invention is very labor-saving and convenient to use when puncturing the skin. The mold among the present invention is a three-plate mould, comprising upper mold, middle mold and lower mold, is provided with the structure that is used to form the base of microneedle array, needle body, peak part and micropinhole etc. parts, can produce the Microneedle array with spikes and micropinholes. The manufacturing method of the microneedle array of the present invention is to use the three-plate mold injection molding process of the present invention, because the demoulding process is carried out step by step, which greatly reduces the demoulding resistance, so the hollow microneedles with sharp peaks can be easily produced array. At the same time, because the mold can be reused, it can be mass-produced, which is conducive to greatly reducing the production cost of the microneedle array, thereby greatly reducing the price of the microneedle array, and is conducive to the popularization and use of the microneedle array.

The above and other objects, features and advantages of the present invention will be more apparent through the following description of preferred embodiments with reference to the accompanying drawings.

Description of drawings

Fig. 1 is the structural representation of the microneedle array of the first embodiment of the present invention;

Fig. 1A is the first cross-sectional view along A-A in Fig. 1;

Fig. 1B is the second sectional view along A-A in Fig. 1;

Fig. 1C is a third cross-sectional view along A-A in Fig. 1;

Fig. 1D is the fourth sectional view along A-A in Fig. 1;

Fig. 2 is the structural representation of the microneedle array of the second embodiment of the present invention;

3 is a schematic structural view of a microneedle array according to a third embodiment of the present invention;

Fig. 4 shows the structural representation of the microneedle array of the 4th embodiment of the present invention;

Fig. 4A is the first cross-sectional view along B-B in Fig. 4;

Fig. 4B is a second cross-sectional view along B-B in Fig. 4;

Fig. 4C is a third cross-sectional view along B-B in Fig. 4;

Fig. 4D is the fourth sectional view along B-B in Fig. 4;

Fig. 5A shows the structural representation of the three-plate mold of the first embodiment of the present invention when closing the mold, the state before the injection of the molten raw material;

Fig. 5B shows the structural schematic view of the three-plate mold of the first embodiment of the present invention when the mold is closed, and the state after injecting the molten raw material;

Fig. 5C represents the structural representation of the first step of demolding in the process of manufacturing microneedle arrays using the three-plate mold of the present invention;

Fig. 5D shows the structural representation of the second step of demolding in the process of manufacturing microneedle arrays using the three-plate mold of the present invention;

Fig. 5E shows the structural representation of the third step of demoulding in the process of manufacturing microneedle arrays using the three-plate mold of the present invention;

Fig. 6A shows the schematic structural view of the three-plate mold clamping of the second embodiment of the present invention;

FIG. 6B shows a schematic diagram of the exploded structure of the three-plate mold of the second embodiment of the present invention;

Fig. 7 shows the structural representation when the three-plate mold clamping of the third embodiment of the present invention;

Fig. 8 shows the structural representation when the three-plate mold of the 4th embodiment of the present invention closes the mold;

Fig. 9A is a structural schematic view of the three-plate mold of the fifth embodiment of the present invention when the mold is closed;

9B is a schematic diagram of the exploded structure of the three-plate mold of the fifth embodiment of the present invention;

Fig. 9C is a first cross-sectional view along D-D in Fig. 9A;

Fig. 9D is a second cross-sectional view along D-D in Fig. 9A;

Fig. 9E is a third cross-sectional view along D-D in Fig. 9A;

Fig. 10A is a schematic structural view of a three-plate mold of the sixth embodiment of the present invention when it is clamped;

10B is a schematic diagram of the exploded structure of the three-plate mold of the sixth embodiment of the present invention;

Fig. 11A is a schematic structural view of the three-plate mold of the seventh embodiment of the present invention when it is clamped;

11B is a schematic diagram of the exploded structure of the three-plate mold of the seventh embodiment of the present invention;

Fig. 11C is a first cross-sectional view along C-C in Fig. 11A;

Figure 11D is a second cross-sectional view along C-C in Figure 11A;

Fig. 11E is a third cross-sectional view along C-C in Fig. 11A.

Detailed ways

Specific embodiments of the present invention will be described in detail below. It should be noted that the embodiments described here are for illustration only, and are not intended to limit the present invention.

As shown in Figure 1, Figure 1A, Figure 1B, Figure 1C and Figure 1D, the number of microneedles included in the microneedle array of the first embodiment of the present invention is relatively small, and its structure includes a base 100 and an integrally formed base 100 Several microneedles 101 are arranged centrally or axisymmetrically. Wherein the base 100 has a liquid storage cavity 102 for storing medical liquid or interstitial fluid. The microneedle 101 has a microneedle hole 103 communicating with the liquid storage cavity 102 . The microneedle 101 includes a needle body part 105 and a peak part 104 integrally formed with the base 100 . The end surface of the peak portion 104 is a slope 107 forming an acute angle with the centerline of the microneedle 101 , and the lower end of the slope 107 is the peak 106 of the peak portion 104 . The length of the microneedle is 50-1200 microns, which is specifically determined by the function of the microneedle (such as drug delivery or sampling, etc.) and the thickness of the skin at the puncture site.

In addition, the microneedles in this embodiment may only include the peak portion 104 instead of the needle body portion 105 . In this case, the length of the microneedle is relatively short, which is suitable for the thinner skin, or when the drug administration and sampling depth are shallow.

In this embodiment, the shape of the base 100 may be rectangular (see FIG. 1A, FIG. 1B ) or circular (see FIG. 1C, FIG. 1D ). The cross-sectional shape of the microneedle 101 can be circular (see FIG. 1B , FIG. 1D ), oval or rectangular (see FIG. 1A , FIG. 1C ). The cross-sectional shape of the micropinhole 103 is circular (not shown in the figure), ellipse (see Fig. 1A, Fig. 1B, Fig. 1C, Fig. 1D), rectangle, triangle (not shown in the figure) or "ten" Character flower shape (see Figure 4A). In a microneedle array, the cross-sectional shape of several microneedle holes 103 may also be a combination of the above-mentioned shapes. The centerline of the microneedle 103 coincides with the centerline of the microneedle 101 , and may deviate from the position of the centerline of the microneedle 103 . A film (not shown) can be formed at the outlet of the microneedle hole 103, which can be used to prevent the leakage of the medicinal solution before the skin is punctured. After the puncture, the film can be destroyed by various methods, such as pressure, vibration, electric current , or chemical reactions, etc.

In this embodiment, the microneedle array is made of plastic, composite material, ceramic or metal material through injection molding process, with low raw material cost and simple manufacturing process. Moreover, since the microneedle has a peak portion 104, and the peak portion 104 has a peak 106, it is particularly labor-saving when penetrating the skin.

As shown in Figure 2, in the microneedle array of the second embodiment of the present invention, the lower end of each microneedle 101 has two slopes 107, and these two slopes 107 are arranged oppositely, and are respectively aligned with the center line of the microneedles 101. into an acute angle. The two slopes 107 intersect with the inner wall of the microneedle 101 , where a peak 106 is formed. In this way, the peak 106 will be formed at or close to the centerline of the microneedle 101 , and the force on the microneedle will be more uniform during use. In this embodiment, among the several microneedles 101 of the microneedle array, all the microneedles 101 may have two bevels 107, or some microneedles may have two bevels 107, and the other part of the microneedles may have two bevels 107 as in the first embodiment. Like the microneedle structure in , there is only one bevel 107 . Other structures of the microneedle array in this embodiment are the same as those in Embodiment 1, and will not be repeated here.

As shown in Figure 3, in the microneedle array of the third embodiment of the present invention, the microneedle hole 103 is a blind hole, and the lower end of the microneedle 101 has two slopes 107, and the two slopes 107 intersect with the microneedle hole 103 below. One outlet 110 communicating with the microneedle hole 103 is formed on each slope 107 , and the two outlets 110 on the two slopes 107 are arranged symmetrically. The number of outlets 110 is not limited to two, and may also be three or four symmetrically arranged. The stress strength of this kind of microneedles is relatively good. Other structures of the microneedle array in this embodiment are the same as those in Embodiment 1, and will not be repeated here.

As shown in FIG. 4 , FIG. 4A , FIG. 4B , FIG. 4C and FIG. 4D , the microneedle array of the fourth embodiment of the present invention includes a relatively large number of microneedles, and several microneedles are arranged symmetrically about the center. It includes microneedles with two structures: one kind of microneedle only has a peak portion 104 formed by a bevel, and the peak is located on one side of the microneedle; the other is located in the center of the base or on a center line of the base, It consists of two slopes forming a peak portion 104, and the peak is located at or near the centerline of the microneedle. As shown in Figure 4A and Figure 4B, several microneedles are arranged in a circular array, wherein the peak portion 104 of the microneedle located in the center of the base 100 is formed by two slopes, and its microneedle hole is in the shape of a "ten" flower; The peak portion 104 of the microneedle is formed by a bevel, and the microneedle hole is elliptical. The cross-sectional shape of the microneedle can be rectangular (see FIG. 4A ), also can be approximately hexagonal (see FIG. 4B ), and of course also can be other shapes such as triangle, ellipse, circle. As shown in Fig. 4C and Fig. 4D, several microneedles are arranged in a rectangular array, and the peak part 104 of a column of microneedles located on the center line of the base 100 is formed by two slopes, and the microneedle holes are in the shape of a "ten" flower, and the others The peak part of the microneedle is formed by a bevel, and the microneedle hole is oval. The cross-sectional shape of the microneedle can be rectangular or approximately hexagonal, or other shapes such as triangular, elliptical, and circular. Other structures of the microneedle array of this embodiment are the same as those of the first embodiment, and will not be repeated here.

The mold of the present invention is a three-plate mold, which can conveniently manufacture the above-mentioned microneedle array with peaks.

As shown in FIG. 5A , FIG. 5B , FIG. 5C , FIG. 5D and FIG. 5E , the three-plate mold structure of the first embodiment of the present invention includes: an upper mold 1 , a middle mold 2 , and a lower mold 3 . in:

The lower mold 3 includes a lower base plate 30 and a lower mold boss arranged on the lower base plate 30 integrally with the lower mold boss. An integrated lower mold cylinder 32 . The inclined surface of the frustum 31 is used to form the inclined lower end surface of the microneedle, and the height of the lower die cylinder 32 is equal to the length of the needle body part 105 of the microneedle. If it is desired to manufacture a microneedle that only has a peak portion but no needle body portion, the lower mold column 32 may not be provided.

The middle mold 2 includes a middle base plate 20, a straight cylindrical middle mold through hole 21 is formed at the central position of the middle base plate 20, and the lower end of the middle mold through hole 21 has a precision fit inclined surface 22 for improving mold clamping precision. On the middle base plate 20, along the circumferential direction of the middle mold through hole 21, several notches with opening directions facing the center line of the middle mold through hole 21 are evenly arranged, and each notch is in common with the frustum 31 and the cylinder 32 of the lower mold 3. A cavity 4 with an opening at the top and a sloped lower surface is formed, and the cavity 4 is used to form microneedles in the microneedle array. The upper end of the middle mold through hole 21 of the middle mold 2 is provided with a lower annular groove 24 along the circumferential direction, and the lower annular groove 24 communicates with the cavity 4 .

The upper mold 1 includes an upper base plate 10, under the upper base plate 10, a number of mold cores 11 having the same number as the number of notches on the middle mold 2 are formed, and the lower end surface of the mold cores 11 is an inclined plane. On the outer side of several mold cores 11 under the upper base plate 10, an upper annular groove 12 opposite to the lower annular groove 24 on the middle mold 2 is provided along the circumferential direction.

When the middle mold 2 and the lower mold 3 are closed, the cone 31 of the lower mold 3 is located in the middle mold through hole 21 of the middle mold 2, and the lower surface of the middle base plate 20 contacts and cooperates with the upper surface of the lower base plate 30 to form a parting surface. 51. The precision fit inclined surface 22 at the lower end of the middle mold through hole 21 of the middle base plate 20 contacts and fits with the outer surface of the frustum 31 of the lower base plate 30 to form a parting surface 52 .

When the upper mold 1 is closed with the middle mold 2 and the lower mold 3, several mold cores 11 are inserted into the corresponding cavities 4, and the inclined surface at the lower end contacts and cooperates with the inclined surface of the frustum 31 of the lower mold 3 to form a parting surface 53 . There is a space between the mold core 11 and the side wall of the cavity 4 . The upper surface of the middle substrate 20 is in contact with the lower surface of the upper substrate 10 to form a parting surface 54 . The lower annular groove 24 on the middle substrate 20 is opposite to the upper annular groove 12 on the upper template 10, and is used to form a part of the base of the microneedle array. There is a space 5 between the inner area surrounded by several mold cores 11 on the upper template 1 and the upper surface of the lower mold cylinder 32 of the lower substrate 30, and the space 5 communicates with the cavity 4 for forming the microneedle array. Another part of the base.

In this first embodiment, the notch for forming the cavity 4 of the microneedle is formed only on the peripheral wall of the through hole 21 of the middle mold 2 . The cavity 4 can also be formed jointly by the middle mold and the lower mold. At this time, in addition to opening a notch on the middle mold, the cavity 4 must also be formed on the lower mold cylinder 32 of the lower mold 3 and the groove of the frustum 31 and the middle mold 2. A notch is also provided on the part where the mouth is aligned, so that the notch provided on the lower mold and the notch provided on the middle mold are docked to form a cavity together.

In this embodiment, the shape of the middle mold through hole 21 on the middle mold 2 matches the shape of the frustum 31 of the lower mold 3 . For example, when the truncated cone 31 was a truncated prism, the middle mold through hole 21 was a polygonal hole, and the number of sides of the polygonal middle mold through hole was the same as the number of edges of the truncated prism; round hole. See Fig. 1A-Fig. 1D, if want to manufacture the microneedle array shown in Fig. 1A, Fig. 1C, then the truncated cone 31 of lower die 3 is a quadrangular truncated truncated prism, and the middle die through hole of middle die 2 is a rectangular hole; For the microneedle array shown in FIG. 1B and FIG. 1D , the frustum 31 of the lower mold 3 is a circular frustum, and the through hole of the middle mold 2 is a circular hole.

In the three-plate mold of this embodiment, an injection port can be set on the upper mold, and the setting of the injection port can be the same as that of the existing two-plate mold, and will not be repeated here.

As shown in Figure 5B, Figure 5C, Figure 5D and Figure 5E, the method for manufacturing a microneedle array using the three-plate mold of the first embodiment of the present invention includes the following steps:

(1) Clamp the lower mold 3, the middle mold 2, and the upper mold 1 in the three-plate mold in sequence.

(2) Inject molten raw materials such as moldable plastics, composite materials, ceramics or metal materials into the mold.

(3) cooling the three-plate mold and the molten raw material therein until the molten raw material is fully solidified.

(4) Step-by-step demoulding: first, the lower mold 3 is separated from the middle mold 2 along the separation surfaces 51, 52, 53. The lower end surfaces of several microneedles in the formed microneedle array are separated from the lower mold boss of the lower mold 3, exposing the inclined lower end surface of the microneedles, and at the same time exposing a part of the outer wall surface of the microneedles close to the centerline of the microneedle array . Then, the middle mold 2 is separated from the upper mold 1 along the parting surface 54 . Other parts of the outer walls of several microneedles in the formed microneedle array are separated from the middle mold 2 by the lower surface of the base and part of the sides, thereby exposing the complete microneedle and part of the base. Finally, the formed microneedle array is detached from the upper mold with mold nails or other auxiliary vibration devices, so that the whole microneedle array and microneedle holes are fully exposed. Vibration devices can be used in the above demoulding process, which is beneficial to reduce the demoulding resistance.

In the method of the present invention, since the demoulding process is carried out in two stages, that is, the lower mold is first disengaged from the middle mold, and the middle mold is disengaged from the upper mold, so that the demoulding resistance is greatly reduced, so that it can be easily Creates the spikes of the microneedles. At the same time, since the mold can easily realize large-scale mass production, the manufacturing cost of the microneedle array manufactured by the injection molding process using the three-plate mold of the present invention is greatly reduced.

6A and 6B show a three-plate mold structure of a second embodiment of the present invention. in:

The lower mold 3 includes a lower base plate 30 and a frustum 31 disposed on the lower base plate 30 and integrated therewith.

The middle mold 2 includes a middle base plate 20, and a middle mold cylinder 33 integrated with the middle base plate 20 is arranged in the middle mold through hole 21 of the middle base plate 20. match. The shape of the bottom surface of the middle substrate 20 matches the shape of the top surface of the lower mold 3 . A central groove 201 is provided on the central upper portion of the middle substrate 20, and the central groove 201 is used to form a part of the base of the microneedle array. A number of peripheral through holes are provided between the middle mold cylinder 33 and the middle base plate 20, and the part of the wall of the middle mold through hole 21 below each peripheral through hole is provided with a notch that is smoothly transitioned to the peripheral through hole. , each peripheral through hole, the notch located below the peripheral through hole and the slope of the frustum 31 jointly form a cavity 4 . The holes 4 communicate with the central groove 201 for forming microneedles in the microneedle array.

In the three-plate mold of the second embodiment, the structure of other parts not described in the lower mold 3 and the middle mold 2 and the structure of the upper mold 1 are the same as those in the first embodiment, and will not be repeated here.

The method of using the three-plate mold of the second embodiment of the present invention to manufacture the microneedle array is the same as the method described in Embodiment 1, including mold clamping, injection, cooling, and demoulding steps. The demoulding process is also carried out in stages, first The lower mold 3 is detached from the middle mold 2, the middle mold 2 is detached from the upper mold 1, and finally the formed microneedle array is detached from the upper mold 1. It will not be described in detail here.

Fig. 7 shows a three-plate mold structure of a third embodiment of the present invention. Compared with the first embodiment, the three-plate mold of the third embodiment is only different in that: among the several notches formed on the middle mold 2, there is a bottom end of each notch, that is, an end adjacent to the lower mold. The inclined surface 6 of the middle mold formed by the center line of the notch at an acute angle. The inclined surface 6 of the middle mold intersects the inclined surface of the lower mold of the frustum 31 of the lower mold 3 , and the angle between the two is an acute angle. The lower end of the inclined surface 6 of the middle mold in the through hole of the middle mold has a precision fitting inclined surface 22 for improving mold clamping precision. This type of mold can produce microneedles with peaks at or near the centerline of the microneedle. The microneedle array shown in FIG. 2 can be manufactured using the three-plate mold of this embodiment.

In the three-plate mold structure of the third embodiment, other structures not described in the middle mold and the structures of the upper mold and the lower mold are the same as those of the three-plate mold of the first embodiment, and will not be repeated here.

The method of using the three-plate mold of the third embodiment of the present invention to manufacture the microneedle array is the same as that described in the first embodiment, and will not be repeated here.

Fig. 8 shows a three-plate mold structure of a fourth embodiment of the present invention. Compared with the third embodiment, the three-plate mold of the fourth embodiment is only different in that: the lower end surface of the mold core 11 formed on the upper mold 1 is a horizontal plane 7 perpendicular to the center line of the mold core 11, rather than an inclined plane, and Two opposite sides of the lower end of the mold core 11 are respectively provided with a chamfer 113 matching the inclined surface of the lower mold and the inclined surface 6 of the middle mold. The cross-sectional areas of the two chamfers 113 are the same. In addition, the size of the cross-sectional area of the chamfer 113 can be changed by changing the size of the chamfer 113 during manufacture, thereby changing the liquid flow rate during use. When closing the molds, the chamfer 113 at the lower end of the mold core 11 is in contact with the inclined surface of the lower mold and the inclined surface 6 of the middle mold respectively. A microneedle array as shown in FIG. 3 can be manufactured using the three-plate mold of the fourth embodiment.

In the three-plate mold structure of the third embodiment, other structures of the upper mold, the structure of the middle mold and the lower mold are the same as those of the three-plate mold of the third embodiment, and will not be repeated here.

The method of using the three-plate mold of the fourth embodiment of the present invention to manufacture the microneedle array is the same as that described in the first embodiment, and will not be repeated here.

9A, 9B, 9C, 9D and 9E show a three-plate mold structure of a fifth embodiment of the present invention.

As shown in FIG. 9A and FIG. 9B , the three-plate mold structure of the fifth embodiment of the present invention includes: an upper mold 1 , a middle mold 2 and a lower mold 3 . in:

The lower mold 3 includes a lower base plate 30 and a plurality of lower mold bosses 34 arranged symmetrically in pairs on the lower base plate 30 . There is at least one lower mold inclined surface 342 on each lower mold boss 34 , and one notch can be arranged on each lower mold inclined surface 342 ; It can be the vertical surface 341 of the lower mold, and a notch can also be set on the vertical surface 341 of the lower mold.

The middle mold 2 includes a middle base plate 20, and the middle base plate 20 is provided with a plurality of middle mold through holes 28 arranged symmetrically in pairs. Correspondingly, and the height of the middle mold through hole 28 is equal to the height of the lower mold boss 34. A central groove 210 communicating with the middle mold through hole 28 is provided above the middle mold through hole 28 in the middle substrate 20 . There is at least one middle mold vertical surface 281 in the hole wall of each middle mold through hole 28, and the middle mold vertical surface 281 can surround a cavity with the corresponding lower mold inclined surface. The face opposite to the vertical surface 281 of the middle mold in the hole wall of each middle mold through hole 28 can also be set to the inclined surface 282 of the middle mold, and the inclined surface 282 of the middle mold can also surround the notch on the corresponding lower mold vertical surface 341 into a hole.

The central position of the middle base plate 20 has one or several "V" shaped grooves 26 arranged along a central line thereof, and two opposite walls of the "V" shaped groove 26 have two notches aligned. Holes can be enclosed. In order to increase mold clamping accuracy, a precision fitting inclined surface 283 is formed on the lower end of the middle mold vertical surface 281 of the middle base plate 20 to contact with the lower mold inclined surface 342, and a row is formed on the lower end of the middle mold inclined surface 282 to be vertical to the lower mold The lower end of the surface 341 contacts the closely fitted vertical surface 289 .

Referring to Fig. 9A, Fig. 9B and Fig. 9C, the horizontal section of the lower mold boss 34 located on the two vertical centerlines of the lower substrate is approximately elliptical (see Fig. 9C), and the vertical section is right-angled trapezoidal (see Fig. 9B) . The right-angled waist of the lower die boss 34 in the shape of a right-angled trapezoid is the vertical face 341 of the lower die, and the oblique waist is the inclined face 342 of the lower die. The vertical surface 341 of the lower mold and the inclined surface 342 of the lower mold are respectively provided with an arc-shaped notch opening outward. One of the opposite wall surfaces of the middle mold through hole 28 on the middle base plate 20 on the two centerlines is the middle mold vertical surface 281 , and the other is the middle mold inclined surface 282 . The lower end of the vertical surface 281 of the middle mold is connected with a precision fit inclined surface 283 , and the lower end of the inclined surface 282 of the middle mold is connected with a precision fit vertical surface 289 . The vertical surface 281 of the middle mold and the inclined surface 282 of the middle mold are respectively provided with arc-shaped notches. The arc-shaped notch on the inclined surface 282 of the middle mold is docked with the arc-shaped notch on the vertical surface 341 of the corresponding lower mold, and the notch on the vertical surface 281 of the middle mold is docked with the notch on the inclined surface 342 of the corresponding lower mold , the paired notches respectively form a cavity with an elliptical horizontal section, which is used to define the outer wall of the microneedle. The horizontal section of the lower mold boss 34 located in the four areas separated by two centerlines is approximately in the shape of a "mountain" (see Figure 9C), and has inclined and vertical surfaces in the vertical direction. Six arc-shaped notches are arranged on each "mountain"-shaped lower mold boss. Correspondingly, the middle mold through hole 28 of the middle base plate 20 located in this area is also in the shape of a "mountain", and six arc-shaped notches are provided on the hole wall. Among the 6 arc-shaped notches, the notch formed on the vertical surface 281 of the middle mold is docked with the notch on the inclined surface 342 of the lower mold, and the notch formed on the inclined surface 282 of the middle mold is connected to the groove on the vertical surface 341 of the lower mold. The mouths are butted, and each pair of two butted notches forms a cavity with an elliptical horizontal section, which is used to define the outer wall of the microneedle. A central position of the middle base plate 20 has a “V” shaped groove 26 .

Referring to Fig. 9A, Fig. 9B and Fig. 9D, the horizontal section of the lower mold boss 34 located on the two vertical centerlines of the lower base plate is surrounded by two straight lines and two arcs, and has an inclined surface and a vertical face up. One of the opposite surfaces of the middle mold through hole 28 on the middle base plate 20 on the two centerlines is the middle mold vertical surface 281 , and the other is the middle mold inclined surface 282 . The lower end of the vertical surface 281 of the middle mold is connected with a precision fit inclined surface 283 , and the lower end of the inclined surface 282 of the middle mold is connected with a precision fit vertical surface 289 . The vertical surface 281 of the middle mold and the inclined surface 282 of the middle mold are respectively provided with a rectangular notch, and the rectangular notch on the inclined surface 282 of the middle mold connects with the vertical surface 341 of the lower mold to form a cavity with a horizontal cross-section that is approximately rectangular. The horizontal section of the lower mold boss 34 located in the four areas separated by two centerlines on the lower base plate 30 is approximately T-shaped (see FIG. 9D); A rectangular notch, these 6 rectangular notches are connected with each face of the T-shaped lower mold boss 34 respectively, forming 6 cavities whose horizontal section is approximately rectangular. A central position of the middle base plate 20 has a “V” shaped groove 26 .

Referring to FIG. 9A , FIG. 9B and FIG. 9E , the lower mold bosses 34 of the lower substrate are rectangular, and several lower mold bosses 34 are parallel and symmetrically arranged on both sides of the center line of the lower substrate. Several rectangular notches are evenly arranged in the middle part of one side of the lower mold boss 34 , and the rectangular notches and the side wall of the middle mold through hole 28 of the middle mold 20 enclose a cavity. The two ends of the same side of the lower mold boss 34 are provided with an angled notch, which forms a cavity with the angled notch arranged on the side wall of the middle mold through hole 28 of the middle mold. The middle mold through hole 28 of the middle mold 20 is also rectangular, and in addition to the upper angular notches, several rectangular notches are also provided, and these rectangular notches are inclined with the lower mold vertical surface 341 of the lower mold boss 34 or the lower mold. The notches on face 342 meet to form a cavity that is rectangular in horizontal cross-section. Several "V" shaped grooves 26 are arranged on the centerline of the middle base plate 20 .

The upper mold 1 includes an upper base plate 10 , and a number of mold cores 11 having the same number as the cavities formed in the middle mold 2 and the lower mold 3 are formed under the upper base plate 10 . One of them located in the central position (see Fig. 9B, Fig. 9C, Fig. 9D) or a row of mold cores 11 (see Fig. 9E) in the shape of a "cross" pattern located on the center line and the cross-sections in other positions are oval or rectangular The structure of the mold core 11 is the same as that shown in FIG. 8 , and will not be repeated here. The upper substrate 10 has an upper annular groove 12 communicating with the cavity. The upper annular groove 12 can also be formed by the upper mold and the middle mold as shown in FIG. 5A , so that the draft resistance will be smaller.

In addition, in this embodiment, it is also possible to set several middle mold protrusions integrated with it on the middle template 20, and each middle mold protrusion has two opposite vertical surfaces, which are respectively connected to the vertical surface of the middle mold and the middle mold. The inclined surfaces of the molds are connected, and notches are respectively arranged on the two vertical surfaces of the protrusions of the middle mold. On the lower die boss, there is a lower die bump that is integrated with it and has the same height as the middle die bump. Each lower die bump has two opposite vertical surfaces, which are respectively inclined to the vertical face of the lower die and the lower die. Surface connection, the two vertical surfaces of the lower die bump are respectively provided with notches. The notch on the vertical surface of the lower mold lug is docked with the notch on the corresponding middle mold lug. The microneedles in the microneedle array produced by the mold of this structure not only have a peak part, but also have a needle body part.

See Figure 9A. When the middle mold 2 and the lower mold 3 are closed, each lower mold boss 34 is located in the corresponding middle mold through hole 28 of the middle mold 2, and the lower surface of the middle base plate 20 contacts and cooperates with the upper surface of the lower base plate 30 to form a split Die face 55. The precision matching vertical surface 289 of the middle base plate 20 contacts and cooperates with the lower end of the lower mold vertical surface 341 of the lower mold boss 34 to form the parting surface 56; The lower end of the mold inclined surface 342 contacts and fits to form the mold parting surface 59 .

When the upper mold 1 is closed with the middle mold 2 and the lower mold 3 , the lower surface of the peripheral area of the upper mold 1 contacts and cooperates with the upper surface of the peripheral area of the middle mold 2 to form a parting surface 54 . Several mold cores 11 are inserted into corresponding cavities. Among them, the lower end of the "ten" flower-shaped mold core is in contact with the side wall of the "V"-shaped groove 26 of the middle base plate 20 to form a parting surface 60; the inclined surface of the lower end of a part of the mold cores in other mold cores is in contact with the lower mold boss 34 The inclined surface 342 of the lower mold of the lower mold contacts and cooperates to form the parting surface 57; There is a space between the mold core 11 and the side wall of the cavity. There is a space between the upper substrate 10 and the lower mold boss 34 .

10A and 10B show the structure of the three-plate mold of the sixth embodiment of the present invention.

As shown in FIG. 10A and FIG. 10B , the three-plate mold structure of the sixth embodiment of the present invention includes: an upper mold 1 , a middle mold 2 and a lower mold 3 . in:

The lower mold 3 includes a lower base plate 30 and several lower mold bosses 34 arranged symmetrically in pairs on the lower base plate 30 . Each lower mold boss 34 has a lower mold vertical surface 341 and a lower mold inclined surface 342 respectively.

The middle mold 2 includes a middle base plate 20, on which there are several middle mold through-holes 28 arranged symmetrically in pairs. The height of the middle mold through hole 28 is equal to the height of the lower mold boss 34 . The plurality of middle mold through holes 28 match with corresponding lower mold bosses 34 on the lower substrate 30 . Two relative vertical faces in the hole wall of middle die through hole 28 are middle die vertical face 281, and wherein with the lower die inclined face 342 of lower die boss 34 opposite middle die vertical face 281 is provided with notch, this The notch and the corresponding inclined surface of the lower mold form a cavity, and the lower end of the vertical surface 281 of the other middle mold is connected with the vertical surface 341 of the lower mold to improve the accuracy of mold clamping and reduce the drag resistance. Precision fit bevel 283.

In this embodiment, a lower mold central boss 340 can also be set at the central position of the lower base plate 30 or several lower mold central bosses 340 can be set along a center line of the lower base plate 30; The straight cylindrical central through hole 29 that the boss 340 matches, the height of the central through hole 29 is equal to the height of the lower die central boss 340, and equal to the height of the middle die through hole 28. Central through hole 29 has a middle mold vertical surface 281, is provided with middle mold inclined surface 282 on the opposite side of this middle mold vertical surface 281, and the lower end of middle mold inclined surface 282 is connected with lower mold central boss 340 lower end. The precision fit bevel 283 that matches with each other. The inclined surface 282 of the middle mold intersects with the inclined surface 342 of the lower mold of the central boss 340 to form an acute angle, and the intersecting inclined surface 282 of the middle mold and the inclined surface 342 of the lower mold of the central boss 340 are respectively provided with notches. The two notches are butt-connected to form the needle body part of the microneedle.

The structure of the upper mold 1 is basically the same as the structure of the upper mold shown in FIG. 9B , and will not be repeated here.

See Figure 10A. When the middle mold 2 and the lower mold 3 are closed, each lower mold boss 34 is located in the corresponding middle mold through hole 28 of the middle mold 2, and the lower mold central boss 340 is located in the central through hole 29 of the middle mold. The vertical surface 281 of the middle mold is in contact with the vertical surface 341 of the lower mold. The lower surface of the middle substrate 20 is in contact with the upper surface of the lower substrate 30 to form a parting surface 55 . The precision fitting inclined surface 283 of the middle base plate 20 contacts and cooperates with the lower end of the lower mold inclined surface 342 of the lower mold boss 34 to form the parting surface 59 .

When the upper mold 1 is closed with the middle mold 2 and the lower mold 3 , the lower surface of the peripheral area of the upper mold 1 contacts and cooperates with the upper surface of the peripheral area of the middle mold 2 to form a parting surface 54 . Several mold cores 11 are inserted into corresponding cavities. The lower end of the "ten" flower-shaped mold core is respectively in contact with the inclined surface 282 of the middle mold of the central through hole of the middle base plate 20 and the inclined surface 342 of the lower mold of the central boss 340 of the lower mold to form the parting surface 60; the lower ends of other mold cores The inclined surface of the lower mold is in contact with the lower mold inclined surface 342 of the lower mold boss 34 to form a parting surface 57. There is a space between the mold core 11 and the side wall of the cavity. There is a space between the lower surface of the upper substrate 10 and the top surface of the lower mold boss 34 .

The difference between the three-plate mold of the sixth embodiment and the fifth embodiment is two points: one is that the cavity for forming the microneedle is completely formed on the middle mold 2, and the inclined surface 342 of the lower mold of the lower mold boss 34 It is only used to form the inclined end surface of the lower end of the microneedle; the second is that the V-shaped groove is formed jointly by the central lower mold boss 340 and the central through hole 29 . In the fifth embodiment, the cavity for forming the microneedle is jointly formed by the notch on the middle mold 2 and the lower mold 3 ; the V-shaped groove is directly formed on the middle mold 2 .

11A, 11B, 11C, 11D, and 11E show a three-plate mold structure of a seventh embodiment of the present invention.

The three-plate mold structure of the seventh embodiment of the present invention includes: an upper mold 1 , a middle mold 2 and a lower mold 3 . in:

The structure of the upper mold 1 and the lower mold 3 is the same as the structure of the three-plate mold in the sixth embodiment, and will not be repeated here.

The difference between the middle mold 2 and the middle mold structure in the sixth embodiment above is that a shoulder integrated with the middle mold 20 is provided on the top side of one of the middle mold vertical surfaces 281 of each middle mold through hole 28 285, the shoulder 285 has a shoulder bottom surface and a shoulder vertical surface 286. Several shoulders 285 are symmetrically arranged in pairs. Notches are provided on the shoulder vertical surface 286 . When the middle mold 2 and the lower mold 3 are closed, the bottom surface of the shoulder 285 is in contact with the top surface of the lower mold boss 34, and the shoulder vertical surface 286 is smoothly transitioned to the lower mold inclined surface 342. The notch on the shoulder vertical surface 286 and the notch on the other middle mold vertical surface 281 of the middle mold through hole 28 opposite to it and the corresponding lower mold inclined surface surround a cavity, and this cavity can be used for A microneedle having a body portion is formed.

The top of the middle base plate 20 between the central through hole 29 of the middle mold 2 and the adjacent middle mold through hole has a boss 288 integral with it, and the boss 288 has two boss vertical surfaces 287 arranged oppositely. , one of the boss vertical surfaces 287 is smoothly transitioned to the inclined surface 282 of the middle mold, and the other boss vertical surface 287 is connected to the side wall of the adjacent middle mold through hole. Both the vertical surfaces 287 of the two bosses are provided with notches, which respectively abut with the notches on the corresponding shoulders 285 . The mold of this embodiment can produce microneedles with a body portion.

While this invention has been described with reference to a few exemplary embodiments, it is to be understood that the terms which have been used are words of description and illustration, rather than of limitation. Since the present invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above-described embodiments are not limited to any of the foregoing details, but should be construed broadly within the spirit and scope of the appended claims. , all changes and modifications falling within the scope of the claims or their equivalents shall be covered by the appended claims.

Claims (29)

1. microneedle array, comprise pedestal (100) and with integrated several micropins of pedestal (100) (101), be provided with the liquid storage cylinder (102) that is used to store medicinal liquid or interstitial fluid in the described pedestal (100), have the micro hole (103) that is communicated with described liquid storage cylinder (102) in described each micropin (101); It is characterized in that described microneedle array is made through injection molding technique by plastics, composite, pottery or metal material; Has the inclined-plane (107) that at least one favours described micropin (101) centrage on described each micropin (101), the outlet of micro hole is positioned at least one described inclined-plane (107), inclined-plane on several micropins (101) is centrosymmetric and arranges or the axial symmetry layout that the outlet end at micropin forms spike part (104) like this.

2. microneedle array as claimed in claim 1 is characterized in that, the quantity of described inclined-plane (107) is one, this inclined-plane (107) and the crossing spike (106) that forms of the outside wall surface of described micropin (101).

3. microneedle array as claimed in claim 1, it is characterized in that, the quantity on described inclined-plane (107) is two, and the internal face that this two inclined-plane (107) intersects at described micropin (101) forms spike (106), and the outlet of described micro hole is positioned on one of them described inclined-plane (107).

4. microneedle array as claimed in claim 1 is characterized in that, the quantity of described inclined-plane (107) is two, intersect at the below of micro hole (103), the outlet of described micro hole has two, lays respectively on described two inclined-planes (107), and these two go out (110) symmetric arrangement.

5. as each described microneedle array of claim 1-4, it is characterized in that between described pedestal (100) and described spike part (104), also having needle body part (105).

6. as each described microneedle array of claim 1-4, it is characterized in that the shape of cross section of several described micro holes (103) is one or more the combination in circle, ellipse, rectangle, triangle or " ten " word flower shape.

7. as each described microneedle array of claim 1-4, it is characterized in that the cross sectional shape of described micropin (101) is circle, ellipse or rectangle.

8. as each described microneedle array of claim 1-4, it is characterized in that the exit of described micro hole (103) is formed with thin film.

9. as each described microneedle array of claim 1-4, it is characterized in that the central lines of the centrage of described micro hole (103) and described micropin (101) or depart from the position of center line of micropin (101).

10. as each described microneedle array of claim 1-4, it is characterized in that described several micropins (101) are arranged to circle, rectangle, circular array or rectangular array.

11. mould of making arbitrary described microneedle array of claim 1-10, 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 described, and described 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), described 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 described counterdie (3) of quantity in described, is formed with the hole that at least one is used to define the micropin outer wall jointly on the substrate (20) or between the middle mould through-hole wall of middle substrate (20) and the counterdie boss in described; During matched moulds, each counterdie boss on the described counterdie (3) stretches into respectively in the corresponding middle mould through hole of middle mould (2), each core rod (11) of described patrix (1) inserts in the corresponding described hole, and core rod (11) bottom contacts cooperation with the counterdie inclined plane of described counterdie boss.

12. the mould of microneedle array as claimed in claim 11 is characterized in that, the quantity of mould through hole was one during described middle substrate (20) was gone up, and middle substrate (20) bottom shape and infrabasal plate end face shape are complementary; In be provided with 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 described 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 described core rod (11) is the inclined-plane, and this inclined-plane contacts cooperation with the counterdie inclined plane of counterdie boss.

13. the mould of microneedle array as claimed in claim 11, it is characterized in that, the quantity of mould through hole was one during substrate (20) was gone up in described, 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 described, and each notch surrounds described hole jointly with the counterdie inclined plane of corresponding counterdie boss; The lower surface of described core rod (11) is the inclined-plane, and this inclined-plane contacts cooperation with the counterdie inclined plane of counterdie boss.

14. the mould of microneedle array as claimed in claim 13, it is characterized in that, has counterdie cylinder (32) above the described counterdie boss with its one, counterdie cylinder (32) is provided with the notch that docks with notch on the middle substrate (20), the notch on the counterdie cylinder (32) and corresponding in the notch of substrate (20) and the counterdie inclined plane of counterdie boss surround described hole.

15. the mould of microneedle array as claimed in claim 11, it is characterized in that, the quantity of the upward middle mould through hole of substrate (20) is one in described, and the bottom of described 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 described core rod (11) is the inclined-plane, and this inclined-plane contacts cooperation with the counterdie inclined plane of counterdie boss.

16. the mould of microneedle array as claimed in claim 11, it is characterized in that, the quantity of the upward middle mould through hole of substrate (20) is one in described, and the bottom of described 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 described core rod (11) is and the vertical horizontal plane of its centrage (7) that the both sides, bottom of core rod (11) have one separately and contact the inclined-plane that cooperates with the counterdie inclined plane and the middle mould inclined plane of described counterdie boss respectively.

17. mould as claim 12,13,14,15 or 16 described microneedle arrays, it is characterized in that, described in the bottom of mould through hole or bottom, middle mould inclined plane 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.

18. the mould of microneedle array as claimed in claim 11, 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 described, have mould vertical plane (281) at least one in the mould through-hole wall in described, have a notch in each on the mould vertical plane (281); Notch and counterdie inclined plane (342) of mould vertical plane (281) surround described hole in described, and the lower surface of described core rod (11) is to contact the inclined-plane that cooperates with counterdie inclined plane (342).

19. the mould of microneedle array as claimed in claim 18 is characterized in that, the opposing one side in mould inclined planes, described 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 described middle mould through-hole wall; Be formed with the hole between the notch of described counterdie vertical plane (341) and the middle mould inclined plane (282), also be provided with below the described patrix (1) and extend in these holes and the lower surface contacts several core rods (11) that cooperate with middle mould inclined plane (282).

20. the mould of microneedle array as claimed in claim 19 is characterized in that, mould inclined plane (282) was provided with 1 notch during each was described, and this notch docks the described hole of formation with notch on the described counterdie vertical plane (341); Each described counterdie inclined plane (342) is provided with 1 notch, this notch with described in notch on the mould vertical plane (281) dock the described hole of formation.

21. mould as claim 18,19 or 20 described microneedle arrays, it is characterized in that, the centrage that the central authorities of described 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, these two notches form the hole; The lower surface of stretching into the core rod in this 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 that contacts cooperation with this V-shaped groove (26).

22. the mould of microneedle array as claimed in claim 21, it is characterized in that, template (20) is provided with the middle mould projection of several and its one in described, the mould projection has two opposing vertical planes in each, be connected with middle mould inclined plane (282) with middle mould vertical plane (281) respectively, be respectively equipped with notch on two vertical planes of middle mould projection; Be provided with above the described counterdie boss (34) and its 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.

23. the mould of microneedle array as claimed in claim 11, it is characterized in that, the opposing one side in mould inclined planes, described 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 described, the middle mould vertical plane (281) that has at least two positioned opposite in the mould through-hole wall in described, have notch on the mould vertical plane (281) in one of them, mould vertical plane (281) contacts cooperation with described counterdie vertical plane (341) in another; Notch during each is described on the mould vertical plane (281) surrounds described hole jointly with corresponding counterdie inclined plane (342).

24. the mould of microneedle array as claimed in claim 23, it is characterized in that, the position of center line that the middle position of described 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; Described lower bolster (3) is provided with the counterdie central boss (340) that can extend into described center through hole (29), this counterdie central boss (340) has the counterdie vertical plane (341) and one and the crossing acutangulate counterdie inclined plane (342), described middle mould inclined plane (282) that contact cooperation with the middle mould vertical plane (281) of described center through hole (29), this counterdie inclined plane (342) is provided with notch, surrounds the hole with notch on the middle mould inclined plane (282); The lower surface of stretching into the core rod in this hole in the described 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 described counterdie inclined plane (342) and contact the inclined-plane that cooperates with middle mould inclined plane (282).

25. the mould of microneedle array as claimed in claim 24, 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 described, the relative in twos symmetric arrangement of several described 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 contacts cooperation with counterdie boss end face, 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 the hole; Middle template (20) top between described 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), these two notches are connected the formation hole with notch butt joint on the corresponding shoulder vertical plane (286) respectively during matched moulds.

26. the mould of microneedle array as claimed in claim 18, it is characterized in that, described 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.

27. the mould of microneedle array as claimed in claim 19, it is characterized in that, described 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.

28. the mould of microneedle array as claimed in claim 11 is characterized in that, the shape of cross section of described some core rods (11) is one or more the combination in circle, ellipse, rectangle, triangle or " ten " word flower shape.

29. the method for arbitrary described microneedle array of manufacturing such as claim 1-10 is characterized in that comprising the steps:

(1) provides three board molds that comprise counterdie, middle mould, patrix;

(2) with counterdie, middle mould, patrix matched moulds in order;

(3) the moldable fused raw material of injection in mould;

(4) described three board molds of cooling and fused raw material wherein fully solidify until fused raw material;

(5) the substep demoulding: earlier with counterdie along therefrom separating on the mould with the parting surface of middle mould; Again with middle mould along separating from patrix with the parting surface of patrix; At last microneedle array is separated from patrix.

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