JP2010075374A - Needle-shaped body device and method of manufacturing the same - Google Patents

Abstract

An object of the present invention is to improve the durability of a mold material and to check the direction of a device.
The needle-shaped body of the present invention is characterized in that one end or several sides are chamfered at the end of the same surface as the bottom surface of the needle-shaped body.
By using the production method and structure of the present invention, it is possible to reduce the load on the mold material during molding, and it is possible to improve the durability of the mold material. In addition, the device direction can be confirmed by providing asymmetry during chamfering.
[Selection] Figure 1

Description

  The present invention relates to a fine needle-like device that enables a medicine to be transmitted from the skin to the body.

  The percutaneous absorption method, which is a method of infiltrating a drug from the skin and administering the drug into the body, is used as a method that can be easily administered without causing pain to the human body. There are drugs that are difficult to administer by transdermal absorption. As a method of efficiently absorbing these drugs into the body, attention has been focused on a method of perforating the skin using a micron-order needle-like body and directly administering the drug into the skin. According to this method, it is possible to easily administer a drug subcutaneously without using a special medication device (see Patent Document 1).

  The shape of the needle-like body used at this time is required to have a sufficient fineness and tip angle for piercing the skin, and a sufficient length for allowing the drug solution to penetrate subcutaneously. It is desirable that the length should be several μm to several hundred μm, and the length should penetrate the stratum corneum that is the outermost layer of the skin and does not reach the nerve layer, specifically about several tens μm to several hundred μm. It is said that.

  The thickness of the stratum corneum varies slightly depending on the site, but is about 20 μm on average. In addition, an epidermis having a thickness of about 200 μm to 350 μm exists under the stratum corneum, and further, a dermis layer in which capillaries are stretched exists under the epidermis. For this reason, in order to penetrate the stratum corneum and allow the chemical solution to penetrate, a needle of at least 20 μm or more is required. Further, when producing a needle-like body for the purpose of blood collection, a needle-like body having a height of at least 350 μm or more is required due to the above-described skin structure.

  In addition, as a material constituting the needle-shaped body, even if a damaged needle-shaped body remains in the body, it is necessary to be a material that does not adversely affect the human body, such as medical silicone, Biocompatible resins such as maltose, polylactic acid, dextran, and polycarbonate are considered promising (see Patent Document 2).

  As an example of a method for producing a fine needle-like body, a technique for producing a mold master using precision machining and etching technology has been proposed (see Patent Document 3).

  In addition, as a method for producing a biocompatible needle-like body, a method of raising a mold material from a mold and performing transfer molding using the mold material has been proposed. (See Patent Document 4).

The known literature is described below.
US Pat. No. 6,183,434 Japanese Patent Laid-Open No. 2005-21677 JP 2002-79499 A JP-T-2007-523771

  In order to produce such a fine structure at a low cost and in large quantities, a transfer molding method represented by an injection molding method, an imprinting method, and a casting method is effective. Is performed by transfer from a mold having a desired shape.

  However, since a mechanical or thermal load is strongly applied to the mold material used at the time of molding, there is a problem that breakage occurs particularly near and around the corner structure.

  In addition, traceability (capability of history management) is indispensable for medical devices, and it is important not only to recognize individual devices but also to confirm the device direction (up, down, left, and right).

  However, it is difficult to confirm the direction of a highly symmetric material. On the other hand, in the case of a shape that is extremely out of symmetry, there is a problem that pressure and heat control at the time of transfer molding is extremely complicated, and shape molding becomes difficult.

  The present invention has been made in order to solve the above-described problems, and an object of the present invention is to provide a needle-shaped body device that satisfies the two conditions of improved formability and improved device direction recognition.

  As a means for solving the above problems, the invention according to claim 1 of the present invention is a needle-like device in which one or a plurality of fine needle-like bodies are arranged on a pedestal, The acicular device is characterized in that chamfering is performed on the upper end of the side surface.

  The invention according to claim 2 of the present invention is the needle-like device according to claim 1, wherein the one side upper end of the pedestal is provided with asymmetry by being chamfered. It is a needle-like body device characterized by.

  The invention according to claim 3 of the present invention is the needle-like device according to claim 1, wherein the asymmetry is obtained by chamfering under different conditions on a plurality of sides at the upper end of the side surface of the pedestal. It is a needle-like device characterized by having it.

  According to a fourth aspect of the present invention, a mold material for molding is produced in a mold material for molding and a method for manufacturing a needle-shaped device by manufacturing a needle-shaped device by molding using the mold material. For producing a needle-like device, characterized in that an original plate in which chamfering is performed on one side upper end of the side surface of the pedestal on which the needle-like body of the needle-like device stands is used Is the method.

  The invention according to claim 5 of the present invention is the method for manufacturing the needle-like body according to claim 4, wherein different conditions are provided for a plurality of sides at the upper end of the side surface of the pedestal on which the needle-like body of the needle-like body device stands. This is a method for producing a needle-like body characterized by using an original plate that has been chamfered.

  The invention according to claim 6 of the present invention is a needle-like device characterized in that a biocompatible material is used as the constituent material of the needle-like device according to any one of claims 1 to 3.

  The acicular device of the present invention is characterized in that chamfering is applied to one side or a plurality of sides at the upper end of the side surface of the pedestal on which the acicular body of the acicular device stands.

  Further, by using the method and structure for producing a needle-shaped device of the present invention, it is possible to reduce the load on the mold material during molding while suppressing the complexity of the pressure and thermal control mechanism, and the durability of the mold material It becomes possible to realize the improvement.

Furthermore, by providing asymmetry during chamfering, it is possible to confirm the device direction required for traceability. This makes it possible not only to identify the mechanical direction using an image apparatus, but also to confirm the device direction visually by adjusting light reflection.

  Moreover, the needle-shaped body device of the present invention is produced by transfer molding using a mold material. In the transfer molding method, by selecting the filling material, it is possible to form even a material in which it is difficult to produce a needle-like body using a mechanical or chemical processing method. It is possible to manufacture efficiently and at low cost. In addition, when a biocompatible material is used as a material for transfer molding, a needle-like body using a material having a low load on the living body can be manufactured. If a biocompatible material is used, even if a fine needle-like body is broken and left in the body, it has an effect that it is harmless.

  The needle-shaped body and the method for producing the needle-shaped body of the present invention can be applied not only to medical treatment but also to various fields that require fine needle-shaped bodies. For example, micro devices, measuring jigs, drug discovery, cosmetics It is also useful as a fine needle-shaped body used for biomaterials and the like, and a method for producing a needle-shaped body.

  Hereinafter, embodiments will be described with respect to an example of the needle device and the manufacturing method of the present invention.

  The acicular device according to the present invention is characterized in that chamfering is performed on the upper end of the side surface of the pedestal on which the acicular body of the acicular device stands. The chamfer size is not particularly determined, but it must be free from shape breakage due to burrs, chipping, and the like. For chamfering, only one side as shown in FIG. 1 and a plurality of sides as shown in FIG. 2 can be selected as appropriate. When chamfering is performed on a plurality of sides, the device can be made asymmetric by selecting different processing widths, processing angles, parallelism, horizontality, surface roughness, and the like. An asymmetric shape can also be produced from a combination of chamfering under a plurality of the same processing conditions and chamfering consisting of one or a plurality of different processing conditions. Moreover, you may be comprised by many surfaces from which an angle differs in chamfering of one side. Alternatively, it may be a machined surface that changes extremely smoothly, such as having a corner R.

  For example, in the case of a rectangular device outer shape, chamfering can be performed on the outer four sides.

  At this time, the four sides do not need to have the same chamfered shape, and the processing conditions may be different on one side or a plurality of sides. The chamfering processing conditions at this time may be arbitrarily selected in consideration of the processing width, processing angle, parallelism, horizontality, and surface roughness. Further, not only the condition for uniformly chamfering all of the sides, but also a structure with chamfered halfway may be employed.

  The general shape of the needle-shaped body device in the present invention is not particularly limited, and a chamfered structure can be provided in a polygonal shape, a circular shape, or a combination thereof.

  The acicular device in the present invention may be a processed product made from an arbitrary processed material. Alternatively, it may be produced by a method in which after a master plate is produced, a duplicated mold is raised, and a mold is used for transfer molding. Alternatively, it may be produced by directly processing a mold material and then using a method of transfer molding.

  Hereinafter, an example of a method for manufacturing a needle-like device according to the present invention will be described with reference to the drawings. Here, an example will be described which is performed by a technique through a process of manufacturing an original plate, a process of manufacturing a mold material, and a process of transfer molding from the mold material. A similar method may be used for directly processing a needle-like body device or a mold material.

<Original plate making process>
First, a needle-like body is produced on a substrate. As a method for manufacturing the needle-like body, a known method may be used, and fine processing used for machining or semiconductor manufacturing can be used. At this time, the material of the base material is not particularly limited, and it is desirable to select the material from the viewpoint of processability and the availability of the material. Examples thereof include metal materials such as SUS, aluminum, and titanium, ceramics such as alumina, aluminum nitride, and machinable ceramics, hard and brittle materials such as silicon and glass, and organic materials such as acrylic and polyacetal.

  Next, chamfering is performed. The chamfering process in the present invention is performed by a fine processing method. The processing method is not particularly limited, and grinding, cutting, wire processing, electric discharge processing, laser processing, etching processing, or the like may be used. Grinding is more preferable. In particular, when a Si substrate is used as the substrate material, any fine processing can be performed by using a grinding blade made of diamond.

  From the above, by controlling the chamfering conditions, an acicular device having an arbitrary shape can be produced. The needle-like body device obtained so far can be used as an original for duplication described below.

<Die material production process>
Next, a method for producing a mold material from an original plate (see FIGS. 3A and 3B) will be described with reference to the drawings. In FIG. 3A, the mold material 31 is filled in the original plate 30. At this time, by adding an additive or the like, the subsequent steps can be favorably advanced. After the mold material is cured, as shown in FIG. 3B, the mold material 33 replicated into the concave mold can be produced by peeling the mold material 31 from the original plate 30. By producing the mold material, a large amount of needle-like bodies can be manufactured from the same mold material, so that the production cost can be suppressed and the productivity can be increased.

  The original plate used here may be subjected to surface shape processing and chemical surface modification before transfer in order to improve mold releasability. Specifically, polishing by machining, drilling, grooving, surface processing and surface modification using an etching process, or application of a release agent can be preferably used.

  The mold raw material is not particularly limited, but a material can be selected in consideration of shape following ability to transfer the original plate satisfactorily, transferability in transfer molding described later, durability, and releasability. Further, a purification step may be added to remove impurities in the mold raw material.

<Transfer molding process>
Next, a transfer molding process using a mold material (see FIGS. 3C and 3D) will be described. In FIG. 3C, the mold material 33 is filled with a molding material 34. The molding material is not particularly limited, but it is preferable to use a medical silicone resin that is a biocompatible material, maltose, polylactic acid, dextran, carbohydrate, polycarbonate, or the like for the needle-like body that becomes the puncture portion. If a biocompatible material is used, even if the needle-shaped body is broken and left in the body, it has an effect that it is harmless. Although there is no restriction | limiting about the filling method of the molding material 34 at this time, From a viewpoint of productivity, the imprint method, the hot embossing method, the injection molding method, the extrusion molding method, and the casting method can be used suitably.

  After filling the molding material 34, it is peeled off from the mold material 33 to obtain a needle-like body 35. At this time, in order to improve the releasability of the mold material, a mold release layer for increasing the mold release effect may be formed on the surface of the mold material (not shown) before filling the needle material. As the release layer, for example, a widely known fluorine-based resin can be used. Moreover, as a formation method of a mold release layer, thin film formation methods, such as PVD method, CVD method, a spin coat method, a dip coat method, can be used suitably.

  From the above, the needle-shaped body and the needle-shaped body of the present invention can be manufactured. The needle-shaped body and the method for producing the needle-shaped body of the present invention are not limited to the above-described embodiments, and include other known methods that can be inferred in each step.

  Hereinafter, examples of the present invention will be described with specific examples. Naturally, the manufacturing method of the acicular body of the present invention is not limited to the following examples, and includes other manufacturing methods that can be inferred from known materials in each step.

  First, using a cutting apparatus having a diamond blade, 25 needle-like bodies arranged in an array of 5 columns and 5 rows on a silicon substrate were produced. The needle-like body obtained at this time was a quadrangular pyramid, the tip angle was 40 °, the height was about 162 μm, and the width of one side of the bottom surface was 231 μm.

  Next, the unprocessed region on the outer periphery of the 25 needle-like bodies was dug down to 300 μm from the substrate surface, so that a planar area was formed on the four outer sides of the 25 needle-like bodies. Chamfering was performed on one side of the outer periphery of the 25 needles thus produced with a grinding wheel having an inclined surface of 45 ° to a depth of 100 μm. As a result, an original plate of a needle-like device having a chamfered side surface shape as shown in FIG.

  Next, in order to replicate the produced acicular device, a mold material was made from the original plate of the acicular device, and a transfer molding process was performed.

  First, a nickel film of 600 μm was formed on the surface of the acicular device by plating.

  Next, the nickel film was peeled off from the acicular device to produce a mold material. Next, a needle-like body device was manufactured using the imprint method for the mold material. Polycarbonate, which is a biocompatible material, was used as the needle-shaped body material to be filled. Through the above steps, a needle-like device made of chamfering made of polycarbonate, which is a biocompatible resin, could be produced.

  In the present embodiment, the load concentrated on the corners of the mold material can be dispersed to improve the durability of the mold material, and the presence or absence of a chamfered area can be visually confirmed instantaneously. As a result, it has become possible to realize two conditions of improvement in work efficiency in forming a needle-like device using a biocompatible material and traceability in the device direction.

  The needle-shaped body device of the present invention can be expected to be used as a fine needle used in a device for transporting drugs such as medicines, drug discovery, and cosmetics.

It is a schematic plan view which shows an example of the chamfering structure of the acicular body of the acicular body device of this invention. It is a schematic plan view which shows an example of the some chamfering structure in the acicular body of the acicular body device of this invention. (A)-(d) is sectional drawing which shows an example of the schematic process for demonstrating the manufacturing process of the acicular body of this invention.

Explanation of symbols

10 ... acicular body 11 ... pedestal 12 ... chamfer A
20 ... Chamfer B
21 ... Chamfer C
22 ... Chamfer D
23 ... Chamfer E
30 ... Original plate 31 ... Mold material 33 ... Mold material 34 ... Molding material 35 ... Needle-shaped body

Claims (6)

  A needle-like device in which one or a plurality of fine needle-like bodies are arranged on a pedestal, wherein the upper end of the side surface of the pedestal is chamfered.   2. The acicular device according to claim 1, wherein an asymmetry is provided by chamfering a side edge of the side of the pedestal.   2. The acicular device according to claim 1, wherein a plurality of sides at the upper end of the side surface of the pedestal are provided with asymmetry by being chamfered under different conditions. device.   In the manufacturing method of the mold material for mold making and the needle-shaped device for manufacturing the needle-shaped body device by the molding process using the mold material, the needle-shaped body device is used as an original plate used for producing the mold material for mold shaping. A method for producing a needle-like device, comprising: using an original plate having a chamfering process on one side upper end of a pedestal on which the needle-like body stands.   5. The method for manufacturing a needle-shaped body according to claim 4, wherein an original plate is used in which chamfering is performed under different conditions on a plurality of sides of the pedestal on which the needle-shaped body of the needle-shaped body device stands. A method for producing a needle-like body, characterized by:   A needle-shaped body device using a biocompatible material as a constituent material of the needle-shaped body device according to any one of claims 1 to 3.

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