JP5031483B2 - Needle-like body, needle-like body manufacturing method, needle-like body manufacturing apparatus - Google Patents

Description

  The present invention relates to a fine needle-like body. In addition, the present invention relates to a needle-shaped body manufacturing method and a needle-shaped body manufacturing apparatus suitable for manufacturing the needle-shaped body.

  In recent years, as a method for administering a physiologically active substance into a living body, a method of transdermal administration using a fine needle-like body has attracted attention. Perforation of the stratum corneum with high barrier properties using fine needles to form a path for the passage of physiologically active substances enables higher penetration of physiologically active substances compared to general transdermal administration It is. At this time, by designing the fine needle-like body so as not to penetrate the stratum corneum and reach the capillaries and nerves, it is possible to prevent bleeding and pain during use.

  When a fine needle-like body is used for the purpose of transdermal administration, the fine needle-like body penetrates through the stratum corneum, which is thin enough to perforate the skin, and the tip corner, the outermost layer of the skin, It is desirable that the needle has a length that does not reach the nerve layer. Specifically, the diameter of the needle-like body is about several μm to 100 μm, the tip of the needle-like body is sharp, and its angle is 30 degrees or less. The length of the needle-like body is preferably about several tens of μm to several hundreds of μm.

  As a material constituting the fine needle-like body, even if a damaged needle-like body remains in the body, it is desirable that the material does not adversely affect the human body, such as medical silicone resin, maltose, Biocompatible materials such as polylactic acid and dextran are considered promising (see Patent Document 1).

  Further, as a method for manufacturing the above-described fine needle-like body, a manufacturing method has been proposed in which an original plate of a needle-like body is produced by X-ray lithography, a duplicate plate is made from the original plate, and transfer processing is performed (Patent Document). 2).

In addition, a manufacturing method has been proposed in which an original plate of needle-like bodies is produced by machining, a duplicate plate is produced from the original plate, and transfer processing is performed (see Patent Document 3).
Japanese Patent Laid-Open No. 2005-21677 JP 2005-246595 A JP-T-2006-513811

  There is a problem that when a force is applied from the outside in a manufacturing process, a transportation process, or the like, a fine needle-like body is broken / deformed. At this time, in particular, destruction / deformation of the protrusion, which is the tip of the needle-like body having poor mechanical strength, is likely to occur.

  Accordingly, the present invention has been made to solve the above-described problems, and an object thereof is to provide a needle-like body that is prevented from being destroyed / deformed when a force is applied from the outside.

  The present invention according to claim 1 is a needle-like body having fine protrusions, a surface opposite to the substrate, the protrusions on the substrate, and the surface of the substrate provided with the protrusions. And a protective layer for protecting the protruding portion.

  The present invention described in claim 2 is the needle-shaped body according to claim 1, wherein the thickness of the protective layer is larger than the length of the protrusion.

  A third aspect of the present invention is the needle according to the first or second aspect, wherein at least the protrusion is formed of a material having biocompatibility. It is a state.

  A fourth aspect of the present invention is the needle-shaped body according to any one of the first to third aspects, wherein the protective layer has a bactericidal or antibacterial action.

  The present invention according to claim 5 is the acicular body according to any one of claims 1 to 4, wherein a plurality of substrates and a protective layer are laminated. .

  The present invention described in claim 6 is the needle-shaped body according to claim 5, wherein the adhesive strength between the surface opposite to the surface provided with the protruding portion of the substrate and the protective layer is greater during lamination. It is a needle-like body characterized in that the adhesive strength between the surface provided with the protruding portion of the opposing substrate and the protective layer is high.

  A seventh aspect of the present invention is the needle-shaped body according to any one of the first to sixth aspects, wherein the substrate is a sheet-shaped substrate.

  The present invention according to an eighth aspect is the acicular body according to the seventh aspect, wherein the substrate and the protective layer are laminated in a roll shape.

The present invention of claim 9 is a method for producing a needle-shaped body having a minute projection, providing a substrate, forming a shape of the projection portion on the substrate, wherein the substrate And a step of laminating a protective layer for protecting the protrusion on a surface opposite to the surface on which the protrusion is formed .

  A tenth aspect of the present invention is the method for manufacturing the needle-shaped body according to the ninth aspect, wherein the substrate is a sheet-like substrate, and each step is performed continuously by a roll-to-roll method. It is a manufacturing method of the acicular body characterized by the above-mentioned.

The present invention according to claim 11 includes a substrate supply unit in which a sheet-like substrate is laminated in a roll on a cylinder, a protective layer supply unit in which a sheet-like protective layer is laminated in a roll on the cylinder, and the substrate A shape transfer portion that transfers the shape of the protrusion to the substrate that has flowed from the supply portion, a surface that is opposite to the surface on which the protrusion has been formed of the substrate that has flowed from the substrate supply portion, and a flow from the protective layer supply portion A needle comprising: a laminating portion for laminating a protective layer, and a needle-like body winding portion for winding the sheet-like needle-like body flowing from the laminating portion into a roll shape It is a shape manufacturing apparatus.

The needle-shaped body of the present invention is characterized in that a protective layer for protecting the protrusion is provided on the surface of the substrate opposite to the surface provided with the protrusion.
According to the configuration of the present invention, by providing the protective layer for protecting the protrusion on the surface opposite to the surface provided with the protrusion of the substrate, the needle-shaped bodies are held in a stacked state. I can do it. At this time, since the protruding portion is covered with the protective layer, it is possible to suppress the destruction / deformation of the protruding portion that is the tip of the needle-like body. Moreover, it has the effect that a storage space can be reduced by laminating acicular bodies.

Hereinafter, the acicular body of the present invention will be specifically described.
The needle-shaped body of the present invention is
A substrate,
A protrusion on the substrate;
A protective layer for protecting the protrusion on the surface opposite to the surface of the substrate having the protrusion;
Is provided.

  FIG. 1 is a diagram showing an example of an embodiment of the present invention. A plurality of fine protrusions 1 are arranged on a flat substrate 2, and a protective layer 3 is formed on the back surface of the surface of the substrate 2 where the protrusions 1 are formed. FIG. 1 shows an example of an embodiment of the present invention, and the shape and arrangement of the protrusions 1, the shape of the substrate, the shape of the protective layer, and the like are not limited to the illustrated forms.

<Board>
The substrate is not particularly limited as long as it has sufficient mechanical properties to hold the protrusion. For example, a metal, an inorganic material, an organic material, or the like may be used.
When the acicular body is applied to living skin, the substrate preferably has biocompatibility and biodegradability. Examples of the material having biocompatibility and biodegradability include polylactic acid, polyglycolic acid, polylactic acid glycolic acid copolymer, polycitric acid, polymalic acid, polyamino acid, maltose, and dextran.
In particular, when the substrate and the protrusion are integrally formed of the same material, the substrate preferably has biocompatibility and biodegradability.

  The substrate is preferably a sheet-like substrate. By using a sheet-like substrate, the substrate can be stored in a state of being laminated in a roll shape on a cylinder. As will be described later, bonding of a protective layer, formation of protrusions, winding of the manufactured needle-like body It is possible to carry out processes such as removing continuously by a roll-to-roll method.

<Protrusions>
The shape of the protrusion may be freely designed depending on the application. For example, for the purpose of promoting percutaneous absorption of a physiologically active substance or for the purpose of taking a substance in a living body percutaneously out of the living body, from the viewpoint of skin puncture performance, an approximate weight with a sharp tip of a needle-like body The shape has a root width of several μm to several hundreds of μm, a length of about several tens of μm to several hundreds of μm, and it is desirable that the side wall of the needle-like body has no constrictions or steps.

  Further, the protrusion may be formed on the substrate using a material different from that of the substrate, or may be integrally formed with the substrate by processing the substrate.

  Moreover, it is preferable that at least the protrusion is formed of a material having biocompatibility. By using a material having biocompatibility, even if the needle-like body is damaged when applied to living body skin and a part of the needle-like body is left in the living body, the influence on the living body can be reduced. Examples of the material having biocompatibility have biocompatibility and biodegradability such as polylactic acid, polyglycolic acid, polylactic acid glycolic acid copolymer, polycitric acid, polymalic acid, polyamino acid, maltose, and dextran. Organic polymer etc. are mentioned. Such organic polymers having biocompatibility and biodegradability are known to have lower mechanical strength than metal materials and the like. The effect that the deformation can be suppressed is particularly effective.

<Protective layer>
The protective layer is provided on the surface of the substrate opposite to the surface provided with the protrusions to protect the protrusions.

The protective layer is preferably made of a material that deforms flexibly when it comes into contact with the protrusion and does not cause excessive deformation of the needle-like body and cause deformation or breakage of the needle-like body, and a soft material is preferably used. Can do.
Here, as the soft material, for example, foamed polymer, hydropolymer, hydrocolloid, hydrogel, rubber, alginate, and the like can be preferably used, but are not limited thereto.

  Moreover, it is preferable that the thickness of a protective layer is larger than the length of a projection part. By making the thickness of the protective layer larger than the length of the protruding portion, the protruding portion can be held inside the protective layer even when the protective layer contacts the substrate on the side provided with the protruding portion during lamination.

  The protective layer preferably has a sterilizing or antibacterial action. When the protective layer has a bactericidal or antibacterial action, when acicular bodies are laminated and held, the acicular bodies can be maintained in a sterilized state. For this reason, it can suppress that a needlelike object is contaminated during a manufacturing process or storage transportation.

Moreover, it is preferable to determine the hardness of the protective layer from conditions such as the material constituting the needle-like body, the shape of the needle-like body, and the load applied to the needle-like body when the needle-like bodies are laminated. For example, when a material or shape suitable for application to living skin is used for the protrusions of the needle-like body, the hardness of the protective layer is preferably 80 degrees or less, and more preferably 50 degrees or less.

  In the needle-shaped body of the present invention, it is preferable that a plurality of substrates and a protective layer are stacked and the needle-shaped bodies are stacked and held. Since the acicular body of the present invention includes a protective layer for protecting the protrusion on the surface opposite to the surface provided with the protrusion of the substrate, it can be held in a stacked state. At this time, since the protruding portion is covered with the protective layer, it is possible to suppress the destruction / deformation of the protruding portion that is the tip of the needle-like body. Moreover, it has the effect that a storage space can be reduced by laminating acicular bodies.

In addition, the adhesive strength between the surface of the substrate provided with the protruding portion of the substrate and the protective layer is greater than the adhesive strength of the surface opposite to the surface provided with the protruding portion of the substrate and the protective layer. preferable.
Separated when the adhesive strength between the surface of the substrate opposite to the surface with the protruding portion of the substrate and the protective layer is lower than the adhesive strength between the surface of the substrate and the protective layer opposite to each other at the time of lamination. In addition, since the surface of each needle-like body is exposed to the atmosphere, attention must be paid to contamination by foreign substances and microorganisms after separation.
By increasing the adhesive strength between the protective layer and the surface provided with the protruding portion of the substrate opposite to the surface having the protruding portion of the substrate and the adhesive strength between the surface opposite to the protective layer and the protective layer, When separating the stacked needle-like bodies into individual needle-like bodies, the protective layers formed on the back surfaces of the individual needle-like bodies are separated in a state of adhering to the opposing needle-like body surface side. For this reason, since the protective layer remains on the surface of the needle-like body, it is possible to avoid contamination of the surface of the needle-like body by foreign matter or microorganisms with the protective layer even in the case of individually separated needle-like bodies. .

  When the acicular bodies according to the present invention are laminated, the acicular body located on the uppermost surface may be separately coated with a protective layer on the side where the projections of the substrate are formed. Thereby, even the acicular body located on the uppermost surface of the laminated acicular body group can be covered with the protective layer. (See FIGS. 6 and 7).

  The protective layer according to the present invention is applied to the skin while being integrated with the acicular body, but only the protective layer may be peeled off as necessary. For example, when the needle-shaped body of the present invention is held by another support material or applied to an applicator, the needle-shaped body may be used after the protective layer is peeled off.

  Moreover, when laminating acicular bodies using a sheet-like substrate, it is preferable that the substrate and the protective layer are laminated in a roll shape. When a sheet-like substrate is used, needle-like bodies can be continuously produced by a roll-to-roll method, and the produced needle-like bodies are laminated and held in a roll shape on a cylinder. At this time, the needle-like body of the present invention is provided with a protective layer for protecting the protrusion on the surface opposite to the surface provided with the protrusion of the substrate. Can be suppressed.

Hereafter, the manufacturing method of the needlelike object of the present invention is explained concretely.
The method for producing the needle-shaped body of the present invention comprises:
Preparing a substrate;
Forming the shape of the protrusion on the substrate;
Laminating a protective layer on the substrate;
Is provided.

<Process for preparing a substrate>
What is necessary is just to prepare the board | substrate suitable for the content mentioned above.

<Process for forming the shape of the protrusion on the substrate>
Next, the shape of the protrusion is formed on the substrate. As a method of forming the shape of the protruding portion on the substrate, a known manufacturing method may be appropriately used depending on the shape.
For example, the substrate may be formed directly using a microfabrication technique.
For example, the mother die may be formed by a microfabrication technique and may be formed by transfer molding using the mother die.
For example, a master die may be formed by a microfabrication technique, a replica plate may be produced from the master die, and transfer molding using the replica plate and a molding material may be used.
Here, as the fine processing technique, for example, a lithography method, a wet etching method, a dry etching method, a sand blast method, a laser processing method, a precision machining method, or the like may be used.
Further, as the transfer molding method, for example, an injection molding method, an extrusion molding method, an imprint method, a casting method, or the like may be used.

<The process of laminating a protective layer on a substrate>
Next, a protective layer is laminated on the substrate. For adhesion between the substrate and the protective layer, a known method may be appropriately used depending on the material and shape of the substrate and the protective layer. At this time, as an adhesion technique, for example, adhesion by an adhesive, adhesion by heat melting, adhesion using surface treatment of the adhesion surface, or the like may be used. If the protective layer has tackiness, contact adhesion utilizing tackiness may be used.

  The step of laminating the protective layer on the substrate and the step of forming the shape of the protrusion on the substrate may be performed in a row, and the shape of the protrusion on the substrate may be added to the subsequent step of the step of laminating the protective layer on the substrate. You may perform the process to form, and the process of forming the shape of a projection part in a board | substrate may be performed in the pre-process of the process of laminating | stacking a protective layer on a board | substrate.

  Further, the substrate is a sheet-like substrate, and the above steps are preferably performed continuously by a roll-to-roll method. Since the needle-shaped body of the present invention includes a protective layer for protecting the protrusion on the surface opposite to the surface having the protrusion of the substrate, it is suitable for holding in a stacked state. In particular, it is suitable for continuous production by a roll-to-roll system.

  Also, when producing a needle-like body by the roll-to-roll method, in the process of forming the shape of the protrusion on the substrate, in particular, a mother mold with the protrusions being inverted is produced, and this mother mold is made up of multiple faces. It is preferable to apply the roll-to-roll type transfer molding method by producing the attached duplicate plate. By applying a roll-to-roll type transfer molding method, the shape of the protrusion can be continuously transferred, and productivity can be drastically improved.

  Moreover, when producing a needle-like body by a roll-to-roll system, it is preferable to laminate a sheet-like board | substrate and a sheet-like protective layer mutually in the process of laminating | stacking a protective layer on a board | substrate. Here, as a laminating method, adhesion by an adhesive, adhesion by heat melting, adhesion using surface treatment of the adhesion surface, or the like may be used.

  As mentioned above, the manufacturing method of the acicular body of this invention can be implemented.

Hereinafter, the acicular body manufacturing apparatus suitable for the acicular body manufacturing method of the present invention will be described.
The acicular body manufacturing apparatus of the present invention is
A substrate supply unit in which sheet-like substrates are stacked in a roll on a cylinder;
A protective layer supply section in which a sheet-shaped protective layer is laminated in a roll on a cylinder;
A shape transfer unit that transfers the shape of the protrusion to the substrate flowing from the substrate supply unit;
A bonding unit for bonding the substrate flowing from the substrate supply unit and the protective layer flowing from the protective layer supply unit;
A needle-like body take-up portion that winds the sheet-like needle-like body that has flowed from the bonding portion into a roll; and
Is provided.

  Each of the substrate supply unit / protective layer supply unit is a part that holds the sheet-shaped substrate and the protective layer in a roll shape on the cylinder, and may be provided with a mechanism that sequentially feeds the substrate and the protective layer as it is processed.

  The shape transfer part is a part for forming a protrusion on the substrate. For example, in the case of forming a projection by forming a duplicate plate and performing transfer processing molding, the portion may be a portion where the duplicate plate is brought into contact with the substrate.

  The bonding unit is a part for bonding the substrate flowing from the substrate supply unit and the protective layer flowing from the protective layer supply unit. It is only necessary to perform a bonding process according to the selected substrate / protective layer. For example, adhesion using an adhesive, adhesion by heat melting, adhesion using surface treatment of the adhesion surface, or the like may be used.

  The shape transfer part and the bonding part may be installed one after the other inside the apparatus, the bonding part is installed in the subsequent process of the shape transfer part, or the bonding part is installed in the previous process of the shape transfer part. May be.

  The needle-like body take-up part is a part that winds the sheet-like needle-like body flowing from the bonding part around a cylinder and holds the needle-like body in a state of being laminated in a roll shape. Since the acicular body of the present invention includes a protective layer for protecting the protrusion on the surface opposite to the surface having the protrusion of the substrate, the needle-shaped body is held in a state of being laminated in a roll shape. It is particularly suitable for continuous production in a roll-to-roll manner.

  Although the embodiments of the present invention have been described above, the technical scope of the present invention is not limited to the above-described embodiments, and changes can be made without departing from the spirit of the present invention.

  Hereinafter, as an example of an embodiment of the method for producing a needle-shaped body of the present invention, a description will be given with reference to FIG. Naturally, the manufacturing method of the needle-shaped body of the present invention is not limited to the following examples, and includes other manufacturing methods that can be analogized. Further, the needle-like body of the present invention is not limited to the needle-like body produced in the following examples.

<Production of mold>
First, by using precision machining, a needle shape in which 100 square pyramidal protrusions (height: 150 μm, bottom surface: 60 μm × 60 μm) are arranged on a silicon substrate in a grid of 10 columns and 10 rows at 1 mm intervals. Formed body. The 100 protrusions were arranged in a square region having a side of about 9 mm.

Next, a nickel conductive layer having a thickness of 100 nm was formed on the acicular body formed of the silicon substrate by sputtering. This conductive layer becomes a seed layer in the subsequent electrolytic plating.
Next, a nickel film having a thickness of 500 μm was formed on the seed layer by electrolytic plating.
Next, the silicon substrate is wet-etched with a potassium hydroxide aqueous solution having a weight percent concentration of 30% heated to 90 ° C. to completely remove it, whereby a needle-shaped mold made of nickel shown in FIG. 6 was produced.

<Needle transfer molding>
Next, as shown in FIG. 2 (a), a needle-like body to polylactic acid is formed by a thermal imprinting method using a sheet-like needle-like substrate 7 made of polylactic acid having a thickness of about 400 μm and the mold 6. Transfer molding was performed.
Next, the mold 6 was peeled off from the needle-like body material 7 to obtain a polylactic acid needle-like body 4 composed of the protrusion 1 and the substrate 2 shown in FIG. The needle-like body 4 has a square quadrangular pyramid (height: 150 μm, bottom: 60 μm × 60 μm) projections 1 on a square substrate 2 having a side of about 18 mm in a 10-column, 10-row grid at 1 mm intervals. It was produced in a form in which 100 lines were arranged. The 100 protrusions were disposed in a square region having a side of about 9 mm and located in a substantially central region on the square substrate 2 having a side of about 18 mm.

<Adhesion of protective layer>
Next, a urethane rubber sheet having a hardness of 30 degrees and a thickness of 1 mm was prepared, and the same side as the substrate of the needle-like body 4 was cut into a square of about 18 mm to form a protective layer 3. Next, the needle-like body 4 and the protective layer 3 are aligned so that they overlap each other, and the back surface of the surface of the needle-like body 4 on which the protrusions are formed and one surface of the protective layer 3 are bonded with acrylic resin. Bonding was performed using an agent.
Thus, the needle-like body 5 according to the present invention shown in FIG. Since the height of the protrusion 1 is 150 μm and the thickness of the protective layer 3 is 1 mm, the thickness of the protective layer in this case corresponds to about 6.7 times the height of the protrusion.

  Hereinafter, an example of the needle-shaped body of the present invention will be described with reference to FIGS.

  First, a plurality of needle-like bodies were produced by the same method as in Example 1. At that time, a part of the needle-like body 4 without the protective layer 3 is produced without carrying out the step of bonding the protective layer 3, and the other part is made of the needle-like body 5 having the protective layer by carrying out the step of bonding the protective layer 3. It was.

<Lamination of acicular body without protective layer>
First, two acicular bodies 4 without a protective layer were laminated such that the protrusions were on the upper side as shown in FIG. Next, using the load tester shown in FIG. 3, the stacked needles 8 are placed on the sample stage 9, and a predetermined indenter 10 of the load tester is used to place the stacked needles 8 on the stacked needles 8. A load 11 was applied. Thereafter, the stacked needle-like bodies 8 were separated into two needle-like bodies 4 without a protective layer. Next, the separated needle-like body 4 without a protective layer was observed with an optical microscope and a scanning electron microscope, and the damage state of the protrusions was examined.

When the load 11 was 1.6 MPa, all 100 protrusions of the needle-like body 4 without the protective layer were damaged. The state of breakage was mainly classified into two cases: the case where the tip of the protrusion was broken and the case where the tip was deformed without breaking.
Next, a similar load test was performed with the load 11 reduced. There were four loads 11 of 0.8 MPa, 0.4 MPa, 0.2 MPa, and 0.1 MPa. As a result, there was a tendency that the degree of breakage of the protrusions was reduced as the value of the load 11 was reduced, but at any load value, damage was caused to all the protrusions of the needle-like body 4 without the two protective layers. It was observed.

  Next, two acicular bodies 4 without a protective layer are laminated as shown in FIG. 4 to prepare a laminated acicular body 8. It separated into the acicular body 4 without a protective layer of a sheet | seat. Subsequently, the damage state of the protrusions was examined by an optical microscope and a scanning electron microscope. As a result, among the stacked needle-like bodies 8, the protrusions of the needle-like body 4 located on the upper side were not damaged, but on the other hand, the protrusions of the needle-like body 4 located on the lower side were partially damaged. Was damaged. From the above results, when acicular bodies 4 without a protective layer were stacked, the degree of breakage of the protrusions increased as the load was increased, and even when no load was applied, the layers were laminated. It was confirmed that the protrusion of the needle-like body 4 located on the lower side of the needle-like body 8 was damaged.

<Lamination of acicular body having protective layer>
Next, the acicular body 5 having a protective layer according to the present invention was laminated.
First, as shown in FIG. 5, two acicular bodies 5 having a protective layer were laminated so that the protrusions were on the upper side, and a laminated acicular body 8 was prepared.
Next, using the load tester shown in FIG. 3, the stacked needles 8 are placed on the sample stage 9, and a predetermined indenter 10 of the load tester is used to place the stacked needles 8 on the stacked needles 8. A load 11 was applied. The load 11 was made into five types of 1.6 MPa, 0.8 MPa, 0.4 MPa, 0.2 MPa, and 0.1 MPa, and a load test was performed on each of the five stacked needle-like bodies 8. Thereafter, the stacked needle-like body 8 was separated into the needle-like body 5 having two protective layers, and observed with an optical microscope and a scanning electron microscope to examine the breakage of the protrusions.

As a result, under all load conditions, damage was confirmed in all the protrusions of the needle-like body 5 having the protective layer positioned on the upper side among the stacked needle-like bodies 8. On the other hand, no damage was found in the protrusions of the needle-like body 5 having the protective layer located on the lower side. In the load test, the protrusion of the needle-like body 5 having the protective layer positioned on the upper side is in contact with the indenter 10 of the load tester, while the protrusion of the needle-like body 5 having the protective layer on the lower side is It was in contact with the protective layer of the needle-like body 5 having the protective layer located on the upper side.
From the above results, when the acicular body 5 having the protective layer is stacked, the effect of the protective layer of the acicular body 5 having the protective layer positioned on the upper side is lowered even when the load is applied up to 1.6 MPa. It was confirmed that the protrusion of the needle-like body 5 having the protective layer positioned was not damaged.

  Next, as shown in FIG. 6, two acicular bodies 5 having a protective layer are laminated so that the protrusions are on the upper side, and the protective layer 3 is arranged thereon, and the acicular bodies 8 are laminated. Prepared. Next, using the load tester shown in FIG. 3, the stacked needles 8 are placed on the sample stage 9, and a predetermined indenter 10 of the load tester is used to place the stacked needles 8 on the stacked needles 8. A load 11 was applied. The load 11 was made into five types of 1.6 MPa, 0.8 MPa, 0.4 MPa, 0.2 MPa, and 0.1 MPa, and a load test was performed on each of the five stacked needle-like bodies 8. Thereafter, the stacked needle-like body 8 was separated into the needle-like body 5 having two protective layers, and observed with an optical microscope and a scanning electron microscope to examine the breakage of the protrusions. As a result, it was confirmed that all protrusions of the needle-like body 5 having the protective layer located on the upper side and the needle-like body 5 having the protective layer located on the lower side were not damaged. From this, even if a load is applied up to 1.6 MPa, the uppermost surface can be obtained by disposing the protective layer 3 on the protrusion of the acicular body 5 having the protective layer located on the uppermost surface of the stacked needle-like bodies 8. It was confirmed that the breakage of the protrusions of the film could be suppressed.

  Further, as shown in FIG. 7, five acicular bodies 5 having a protective layer are laminated so that the protrusions are on the upper side, the protective layer 3 is disposed thereon, and a similar load test is performed. It was confirmed that all the protrusions of the needle-like body 5 having the protective layer were not damaged even when the maximum pressure of 1.6 MPa was applied.

<Contamination prevention effect>
First, a plurality of needle-like bodies 5 having a protective layer were produced by the same method as in Example 1, and the needle-like bodies 5 having a protective layer were formed as shown in FIG. A stack of needles 8 was prepared. Next, an aqueous chemical solution in which the fluorescent particles were dispersed was prepared, and after sprinkling over the entire surface of the stacked needle-like bodies 8, it was dried to adhere the fluorescent particles to the surface of the stacked needle-like bodies 8. Thereafter, the stacked acicular bodies 8 were separated into acicular bodies 5 having two protective layers, and the surface of the two acicular bodies 5 was observed with an optical microscope while irradiating excitation light of fluorescent particles. A large number of light emission of fluorescent particles was confirmed on the surface of the needle-like body 5 having a protective layer positioned above at the time of lamination. On the other hand, on the surface of the needle-like body 5 having a protective layer positioned below at the time of lamination, No emission of fluorescent particles was confirmed. From this result, it was confirmed that by laminating acicular bodies having a protective layer, the effect of protecting the acicular bodies from external contamination was obtained.

  The needle-shaped body of the present invention can be used not only as a needle-shaped body for transdermal administration but also as a fine needle-shaped body used in various fields such as medicine, drug discovery, cosmetics, and MEMS devices.

It is the schematic which shows an example of the acicular body of this invention. It is a schematic sectional drawing for explaining an example of a needlelike object manufacturing process by an embodiment of the present invention over time. It is a schematic sectional drawing which shows an example of the load test method in the Example of this invention. It is a schematic sectional drawing for demonstrating an example of acicular body lamination | stacking. It is a schematic sectional drawing for demonstrating an example of the acicular body lamination | stacking in embodiment of this invention. It is a schematic sectional drawing for demonstrating an example of the acicular body lamination | stacking in embodiment of this invention. It is a schematic sectional drawing for demonstrating an example of the acicular body lamination | stacking in embodiment of this invention.

Explanation of symbols

1 …… Protrusions,
2 ... Board,
3 ... Protective layer,
4 ... acicular body,
5 ... Acicular body having a protective layer,
6 ... Acicular base material,
7 …… Mold,
8 ... Sample stage,
9 …… Laminated needles,
10 ... Indenter,
11 …… Load,

Claims (11)

A needle-like body having fine protrusions,
A substrate,
A protrusion on the substrate;
A protective layer for protecting the protrusion on the surface opposite to the surface of the substrate having the protrusion;
A needle-like body characterized by comprising: The acicular body according to claim 1,
The acicular body, wherein the thickness of the protective layer is larger than the length of the protrusion. The needle-shaped body according to claim 1 or 2,
At least the protrusion is formed of a material having biocompatibility. The acicular body according to any one of claims 1 to 3,
The acicular body characterized in that the protective layer has a bactericidal or antibacterial action. The needle-shaped body according to any one of claims 1 to 4,
A needle-like body characterized in that a plurality of substrates and a protective layer are laminated. The acicular body according to claim 5,
It is characterized in that the adhesive strength between the surface having the protruding portion of the substrate and the protective layer opposed to each other at the time of lamination is larger than the adhesive strength between the surface opposite to the surface having the protruding portion of the substrate and the protective layer. Needle-like body. The acicular body according to any one of claims 1 to 6, wherein the substrate is a sheet-shaped substrate. The acicular body according to claim 7,
A needle-like body comprising a substrate and a protective layer laminated in a roll shape. A method for producing a needle-like body having fine protrusions,
Preparing a substrate;
Forming the shape of the protrusion on the substrate;
Laminating a protective layer for protecting the protrusion on the surface of the substrate opposite to the surface on which the protrusion is formed ;
A method for producing a needle-like body comprising: It is a manufacturing method of the acicular body according to claim 9,
The substrate is a sheet-like substrate,
Each process is continuously performed by a roll-to-roll system, The manufacturing method of the acicular body characterized by the above-mentioned. A substrate supply unit in which sheet-like substrates are stacked in a roll on a cylinder;
A protective layer supply section in which a sheet-shaped protective layer is laminated in a roll on a cylinder;
A shape transfer unit that transfers the shape of the protrusion to the substrate flowing from the substrate supply unit;
A bonding portion that bonds the surface of the substrate that has flowed from the substrate supply portion to the surface opposite to the surface on which the protrusions are formed and the protective layer that has flowed from the protective layer supply portion;
A needle-like body take-up portion that winds the sheet-like needle-like body that has flowed from the bonding portion into a roll; and
A needle-shaped body manufacturing apparatus comprising: