Medicament administration device
阅读说明:本技术 药剂施予装置 (Medicament administration device ) 是由 加藤洋行 住田知也 儿玉贤洋 内藤诚之郎 于 2015-11-12 设计创作,主要内容包括:一种药剂施予装置,具备:基体,具有第1面;突起部,从上述第1面突出,具有周面;以及作为固态物的药剂,与上述第1面交叉的1个方向是第1方向,沿着上述第1面的1个方向是第2方向,在上述突起部形成有收纳部,上述收纳部沿着上述第1方向划分出朝向上述基体凹陷的空间,并以沿着上述第2方向将上述突起部贯通而在上述周面的一部分开口的方式沿着上述第2方向延伸,沿着上述第2方向观察到的上述收纳部的宽度随着接近上述基体而变小,上述药剂被收纳在上述收纳部。(A medicine administering device is provided with: a base having a 1 st face; a protrusion portion protruding from the 1 st surface and having a peripheral surface; and a drug as a solid, wherein 1 direction intersecting the 1 st surface is a 1 st direction, 1 direction along the 1 st surface is a 2 nd direction, the protrusion has a receiving portion formed thereon, the receiving portion defines a space recessed toward the base along the 1 st direction, extends along the 2 nd direction so as to penetrate the protrusion along the 2 nd direction and open to a portion of the peripheral surface, and has a width as viewed along the 2 nd direction that decreases as approaching the base, and the drug is received in the receiving portion.)
1. A medicament administration device, characterized in that,
the disclosed device is provided with:
a base having a 1 st face;
a protrusion portion protruding from the 1 st surface and having a peripheral surface; and
as a medicament for a solid substance,
the 1 st direction intersecting the 1 st plane described above is the 1 st direction,
the 1 st direction along the 1 st plane is the 2 nd direction,
the protrusion is formed with a receiving portion,
the housing portion defines a space recessed toward the base along the 1 st direction, extends along the 2 nd direction so as to penetrate the protrusion portion along the 2 nd direction and open to a part of the peripheral surface, and has a width as viewed along the 2 nd direction that decreases as the housing portion approaches the base,
the medicine is stored in the storage portion.
2. The medicament administration device according to claim 1,
the protrusion has a conical shape and a tip end portion having a pointed shape,
the housing portion is disposed at a position offset from the center of the protrusion portion when viewed from a direction facing the 1 st surface.
3. The medicament administration device according to claim 1,
the peripheral surface of the protrusion extends in a conical shape from the 1 st surface,
the receiving portion is disposed at the center of the protrusion portion when viewed from a direction facing the 1 st surface.
4. The medicament administration device according to claim 1,
the above-mentioned drug is a freeze-dried drug.
5. The medicament administration device according to claim 1,
the receiving part is a groove with a bottom part,
the bottom of the groove is located apart from the base in the 1 st direction.
6. The medicament administration device according to claim 1,
the medicine applicator has a plurality of the projections,
the 2 nd direction of each of the plurality of protrusions is the same direction.
Technical Field
The present invention relates to a drug delivery device such as a microneedle for delivering a drug and a method for manufacturing the drug delivery device.
Background
As a drug administration device for administering a drug from the skin into the body, a microneedle is known. The microneedle has a plurality of projections having a needle shape on a surface of a base. In a method of administering a drug using a microneedle, a base is pressed against the skin, a protrusion perforates the skin, and the drug is delivered into the body through a hole formed in the protrusion (see, for example, patent document 1).
Disclosure of Invention
Problems to be solved by the invention
The microneedle provided with a drug is formed by, for example, applying a liquid drug to the surface near the tip of the protrusion and drying the drug. However, in the case of this configuration, if a certain amount or more of the drug is applied to the projection, the drug is solidified in a state of being relatively circularly concentrated at the tip of the projection, and the piercing performance of the projection is lowered, and the amount of the drug that can be applied is largely restricted. As a result, the amount of medicament that can be administered using microneedles is also greatly limited.
In view of the above circumstances, an object of the present invention is to provide a drug administration device and a method of manufacturing the drug administration device that can increase the amount of a retainable drug.
Means for solving the problems
The medicine administering device for solving the above problems includes: a base having a 1 st face; a protrusion portion protruding from the 1 st surface and having a peripheral surface; and a solid drug, wherein 1 direction intersecting the 1 st plane is the 1 st direction; the 1 st direction along the 1 st surface is the 2 nd direction; a receiving portion is formed in the protrusion portion; the housing portion defines a space recessed toward the base body along the 1 st direction, extends along the 2 nd direction, and opens to a portion of the peripheral surface of the protrusion portion, and the medicine is housed in the housing portion.
According to the above configuration, since the medicine is accommodated in the accommodating portion recessed toward the inside of the protruding portion, the amount of the medicine that can be held by the medicine administering device can be increased as compared with a configuration in which the medicine is attached to the surface of the protruding portion.
In the above configuration, it is preferable that the drug is a lyophilized drug.
According to the above configuration, since the medicine administering device includes the freeze-dried medicine, the medicine administering device can be stored for a long period of time.
In the above configuration, it is preferable that the receiving portion penetrates the protrusion portion in the 2 nd direction.
According to the above configuration, since the medicine easily enters the housing portion, filling of the medicine becomes easy.
In the above configuration, preferably, the housing portion is a groove having a bottom; the bottom of the groove is located apart from the base in the 1 st direction.
According to the above configuration, the mechanical strength of the protrusion can be improved at the base of the protrusion where stress is likely to concentrate, as compared with a configuration in which the bottom of the groove reaches the base. Further, since the medicines are collectively arranged at a portion of the protruding portion which is deeper into the skin, the medicines accommodated in the grooves are easily fed into the body of the administration subject.
In the above configuration, it is preferable that the protrusion has a pointed tip end portion having an apex; the apex is located at an edge of the protrusion when viewed in a direction facing the 1 st surface.
According to the above configuration, the protrusion has a pointed distal end portion, so that the ease of penetration of the protrusion into the skin can be improved, and the distal end of the protrusion is disposed at the edge portion of the protrusion, so that the degree of freedom in the size, shape, and position of the housing portion disposed in the region avoiding the distal end is improved.
In the above configuration, it is preferable that the medicine administering device includes a plurality of the projections, and the 2 nd directions of the plurality of the projections are the same direction.
According to the above configuration, since the direction in which the housing portion is formed is the same for each of the plurality of protruding portions, the housing portion can be formed at a time for the plurality of protruding portions or the housing portion can be formed for each of the plurality of protruding portions continuously by using various processing techniques such as machining or laser processing. Thus, the production efficiency of the medicament administration device can be improved.
A method for manufacturing a drug administration device that solves the above problems includes: a first step of manufacturing a main body portion having a base body having a 1 st surface and a protrusion portion protruding from the 1 st surface, the protrusion portion having a peripheral surface and a receiving portion formed thereon; a 2 nd step of filling the housing with a liquid chemical; and a 3 rd step of drying the chemical filled in the housing section; 1 direction crossing the 1 st surface is the 1 st direction; the 1 st direction along the 1 st surface is the 2 nd direction; the housing portion defines a space recessed toward the base body along the 1 st direction, and extends along the 2 nd direction to open at a part of the peripheral surface of the protrusion portion.
According to the above method, the above medicine administering device can be manufactured. According to such a medicine administering device, the amount of medicine that can be held can be increased as described above.
In the method, it is preferable that the chemical is freeze-dried in the 3 rd step.
According to the above method, since the drug is freeze-dried, long-term storage of the drug administration device can be achieved.
ADVANTAGEOUS EFFECTS OF INVENTION
According to the present invention, an increase in the amount of medicament that can be held by the medicament administration device can be achieved.
Drawings
Fig. 1 is a perspective view showing a three-dimensional structure of a microneedle which is an example of a drug administration device according to an embodiment.
Fig. 2 is a sectional view showing a sectional structure of a microneedle according to an embodiment.
Fig. 3 is a perspective view showing a three-dimensional structure of a microneedle, that is, a microneedle having a plurality of projections according to an embodiment.
Fig. 4 is a view showing a process for manufacturing a microneedle according to an embodiment, and shows a manufactured body.
Fig. 5 is a diagram showing a process for manufacturing a microneedle according to an embodiment, and shows an example of a process for filling a drug.
Fig. 6 is a diagram showing a process for manufacturing a microneedle according to an embodiment, and shows an example of a process for filling a drug.
Fig. 7 is a view showing a process for producing a microneedle according to an embodiment, and shows the microneedle after the freeze-drying process.
Fig. 8 is a sectional view showing a sectional structure of a microneedle according to a modification.
Fig. 9 is a sectional view showing a sectional structure of a microneedle according to a modification.
Fig. 10 is a perspective view showing a three-dimensional structure of a microneedle according to a modification.
Fig. 11 is a perspective view showing a three-dimensional structure of a microneedle according to a modification.
Fig. 12 is a perspective view showing a three-dimensional structure of a microneedle according to a modification.
Fig. 13 is a perspective view showing a three-dimensional structure of a microneedle according to a modification.
Fig. 14 is a side view showing a side structure of a microneedle according to a modified example.
Fig. 15 is a perspective view showing a three-dimensional structure of a microneedle according to a modification.
Fig. 16 is a perspective view showing a three-dimensional structure of a microneedle according to a modification.
Fig. 17 is a perspective view showing a three-dimensional structure of a microneedle according to a modification.
Fig. 18 is a perspective view showing a three-dimensional structure of a microneedle according to a modification.
Fig. 19(a) is a diagram showing a photographed image of a main body portion of a microneedle according to an example, and fig. 19(b) is a schematic diagram schematically showing the main body portion of the photographed image of fig. 19 (a).
Fig. 20(a) is a diagram showing a photographed image of the protrusion before filling of the drug in the microneedle of the example, and fig. 20(b) is a diagram showing a photographed image of the protrusion after filling of the drug in the microneedle of the example.
Fig. 21(a) to 21(c) are views showing observation images of the diffusion process of the drug using the microneedles of the examples.
Fig. 22(a) is a diagram showing a photographed image of a main body portion of a microneedle of a comparative example, and fig. 22(b) is a schematic diagram schematically showing the main body portion of the photographed image of fig. 22 (a).
Fig. 23(a) is a diagram showing a photographed image of the protrusion before filling of the drug in the microneedles of the comparative example, and fig. 23(b) is a diagram showing a photographed image of the protrusion after filling of the drug in the microneedles of the comparative example.
Detailed Description
With reference to fig. 1 to 7, an embodiment in which a drug administration device is embodied as a microneedle will be described as an embodiment of a drug administration device and a method for manufacturing a drug administration device.
[ Structure of microneedle ]
The structure of the microneedle will be described with reference to fig. 1 to 3.
As shown in fig. 1, a microneedle 10 includes a plate-
In the example shown in fig. 1, the structure composed of the
A
In other words, the
The
As shown in fig. 2, the bottom of the
The length Lt of the
The size of the
The length Lm from the 1 st surface S1 to the bottom of the
The
As shown in fig. 3, the number of the
In the case where the microneedle 10 has a plurality of
In the case where the microneedle 10 has a plurality of
When the microneedle 10 is used, the
According to such a structure, since the freeze-dried
In addition, microneedles are known which are made of a material such as a polymer having solubility in water and contain a drug in a protruding portion. When such a microneedle is used, the drug is dissolved in a state where the protruding portion penetrates into the skin of the administration target, and the drug is delivered into the body of the administration target. When an attempt is made to increase the amount of a drug to be administered by using a microneedle having such a structure, the ratio of the drug in the constituent components of the protruding portion becomes high, and the ratio of a component for improving mechanical strength, such as a polymer, becomes low, so that the mechanical strength of the protruding portion becomes low. As a result, the piercing performance of the protrusion is reduced. In addition, the microneedles having such a structure are easily deformed by moisture, and as a result, the puncture performance of the projections is easily degraded by storage.
In contrast, in the present embodiment, since the
In addition, a microneedle including a liquid drug is known in the related art, and when such a microneedle is used, the liquid drug is applied through, for example, a through hole provided in a protrusion, and is supplied from the outside in accordance with the penetration of the protrusion. However, in a structure in which microneedles are provided with a liquid drug and these are stored together, since the liquid drug is not suitable for long-term storage, the service life of the microneedles has to be set to a relatively short period of time.
In contrast, in the present embodiment, since the drug held by the microneedle 10 is freeze-dried, the microneedle 10 containing the drug can be stored for a long period of time.
[ method for producing microneedle ]
A method for manufacturing the microneedle 10 will be described with reference to fig. 4 to 7.
As shown in fig. 4, first, the main body portion 15 having the base 11 and the
The main body 15 is preferably formed of a biocompatible material, and among such materials, a material that can withstand the freeze-drying process of the drug is used as the material for forming the main body 15. Examples of such a material include silicon, metals such as stainless steel, titanium, and manganese, and resins such as medical silicon, polylactic acid, polyglycolic acid, polycarbonate, and cyclic olefin polymers. As a material for forming the main body 15, a water-soluble polymer may be used.
The body portion 15 may be manufactured using various known techniques. For example, the body 15 is formed by machining such as cutting or drilling, forming techniques such as laser processing and injection molding, etching, or the like, depending on the material constituting the body 15. Alternatively, the main body 15 may be transferred by preparing an original plate of the main body 15 by such a method, preparing an intaglio plate in which the unevenness of the original plate is inverted by a plating method or a molding method using a resin, and using the prepared intaglio plate.
The main body 15 may be formed by transfer molding using a mold produced by machining. More specifically, the main body 15 may be formed by injection molding, compression molding, blow molding, or the like using a mold using a resin material as a material for forming the main body 15.
In the main body portion 15 of the present embodiment, since the
Next, as shown in fig. 5, the
The type of the drug is not particularly limited as long as it functions by being administered into the skin, that is, the drug can be lyophilized, and the drug may be a pharmacologically active substance such as a vaccine or a cosmetic composition having a cosmetic effect.
Here, in the body portion 15 of the present embodiment, the
In addition, in the structure of the present embodiment, it is easy to ensure a wide entrance for the medicine to enter the housing portion. Since the
In the case where the medicine is filled by utilizing the capillary phenomenon, in the structure of the present embodiment, the sucking up of the medicine by the capillary phenomenon is controlled by the material constituting the
On the other hand, in the case where the medicine is filled by dropping the medicine in the form of droplets, in the structure of the present embodiment, compared with the structure in which the housing portion that is open only in the direction orthogonal to the 1 st surface S1 is formed, the droplets are more likely to hang on the housing portion on the upper surface S4 of the
As shown in fig. 7, by freeze-drying the drug filled in the
As described above, the microneedle 10 serving as the drug administration device of the present embodiment can provide the following effects.
(1) Since the drug is stored in the
The microneedle 10 can be manufactured by a manufacturing method including a step of manufacturing the body 15 including the
(2) The
Further, according to the above configuration of the housing unit of the present embodiment, the volume of the housing unit can be more easily ensured to be larger than the configuration in which the housing unit is opened only in the direction orthogonal to the 1 st surface S1, and therefore the housing amount of the medicine can be easily increased. Further, since the amount of the drug exposed to the surface of the
(3) Since the bottom of the
(4) Since the
(5) The
In the above configuration, the inclination angle from the distal end to the proximal end of the
(6) In the plurality of
[ modified examples ]
A modified example of the shape of the microneedle will be described with reference to fig. 8 to 18. In the following, the same components as those of the above-described embodiment are assigned the same reference numerals, and the description thereof is omitted.
The microneedle 20 shown in fig. 8 has a
In the microneedle 30 shown in fig. 9, a through
In this case, when the microneedle 30 is used, it is preferable that a liquid including water is injected into the through
With this configuration, a large space can be ensured in which the freeze-dried
The microneedle 40 shown in fig. 10 has a groove 43 instead of the
The microneedle 50 shown in fig. 11 has a groove 53 instead of the
In addition, from the viewpoint of improving the ease of forming the grooves and the mechanical strength of the
The microneedle 60 shown in fig. 12 has a protruding
In such a configuration, the
The microneedle 70 shown in fig. 13 has a protruding
Further, the protrusion is not limited to the examples described above, and may have a quadrangular pyramid shape, or may have a shape such that the tip end is not sharp, such as a cylindrical shape or a prismatic shape. The protrusion may have a shape obtained by joining 2 or more three-dimensional bodies, such as a shape in which a cone is laminated on a cylinder. In short, the effect (1) can be obtained if the projection is shaped to pierce the skin and the freeze-dried drug is stored in the storage portion formed in the projection.
For example, the projections may have a curved upper surface S8, as in the projections 82 of the microneedles 80 shown in fig. 14. The upper surface S8 of the protrusion 82 is formed by cutting using a cutting tool that is curved, for example.
The shape of the housing portion is not limited to the above-mentioned examples, and the housing portion may extend obliquely with respect to the direction in which the protrusion extends. That is, the 1 st direction is not limited to the direction perpendicular to the 1 st surface S1, and may be 1 direction intersecting the 1 st surface. In short, the above-described effect (2) can be obtained if the housing section extends in the direction intersecting the 1 st surface S1 in the direction away from the
Specifically, as in the groove 93 of the microneedle 90 shown in fig. 15, the size of the region occupied by the groove in the plane parallel to the 1 st plane S1 may be reduced as it approaches the bottom of the groove. In the example shown in fig. 15, the width Dm of the groove 93 becomes smaller as the groove approaches the
As shown in fig. 16, the microneedle 100 may have a groove 103, and the bottom surface of the groove may be curved. In this case, the most recessed portion in the bottom surface, i.e., the portion closest to the base 11 in the bottom surface, is the bottom of the groove.
The width Dm of the groove may vary in the 2 nd direction, which is a direction along the 1 st surface S1 in which the groove extends. For example, as in the
In addition, a specific example of the drug administration device is not limited to a microneedle, and the length Lt of the protrusion may be several tens of mm or more as long as the portion of the protrusion, which contains the lyophilized drug, is penetrated into the skin. In this case, when the medicine administration device is used, for example, a spacer (spacer) is used which adjusts the length of the projection to be inserted into the skin to such an extent that the portion of the projection in which the freeze-dried medicine is stored remains in the skin. In such a configuration, when the liquid medicine is filled into the housing portion, the medicine is prevented from adhering to the
The drug stored in the storage unit is not limited to a freeze-dried drug, and may be a dry drug. That is, the medicine provided in the medicine administering device may be solid. Examples of the drying method instead of freeze drying include room temperature drying, vacuum drying, and heat drying. With this configuration, the amount of the medicine that can be held by the medicine administering device can be increased.
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