JP7757109B2 - Microneedle array puncture device - Google Patents

Description

The present invention relates to a microneedle array puncture device.

Transdermal drug administration using transdermal drug delivery preparations is one method of non-invasively administering drugs. However, because the skin has an extremely high barrier function, it is generally considered difficult to absorb drugs through the skin, the administration site, and have the drug's effects manifest over a wide area of the body.
Therefore, drugs with low skin permeability, such as high molecular weight drugs, are difficult to apply to transdermal absorption agents, and currently these drugs are still mainly administered by injection.

Against this background, efforts are underway to develop less invasive injection technologies, one of which is microneedles. Microneedles are needles that have been miniaturized to the point that they do not cause pain when piercing the skin. Microneedles are made from metals, the same as conventional injection needles, as well as microneedles made from polymeric materials such as silicone.

These microneedles have a hollow structure similar to that of an injection needle, are several hundred micrometers long, and are used to inject a medicinal solution into the skin.
A known conventional microneedle has a structure in which a plurality of needles having the above-mentioned length are arranged in an array.
However, when removing conventional microneedles from a packaging container, there is a concern that the tip of the needle may be unintentionally touched, resulting in contamination or damage to the needle.
For this reason, a microneedle puncture device has been proposed that allows the entire process of removing the microneedle array from the packaging container, puncturing, holding, and discarding it without unintentionally touching the needles, as described in Patent Document 1 below.

Patent No. 6644666

The microneedle array described in Patent Document 1 has a structure in which an inner tube is slidably fitted into an outer tube, a microneedle is attached to the tip of a plunger that penetrates the top wall of the outer tube and the top wall of the inner tube, and the microneedle is protected by the inner tube. The opening at the bottom end of the inner tube is then pressed against the skin, and the plunger is used to bring the microneedle close to the skin and puncture it, allowing the microneedle that has penetrated the epidermis to inject a medicinal solution into the dermis.

However, because the epidermis that is punctured by the microneedles is flexible and the needle length of the microneedles is only a few hundred micrometers, there is a risk that the epidermis may move in the direction of the puncture, resulting in insufficient puncture and preventing the drug solution from reaching the dermis.

The present invention was made in consideration of the above circumstances, and aims to provide a microneedle array puncture device that can reliably puncture the skin with microneedles and improve puncture performance.

(1) A microneedle array puncture device according to this embodiment is a microneedle array puncture device comprising a cylindrical applicator body detachably attached to the tip of a syringe containing a liquid, and a needle array equipped with microneedles attached to the tip side of the applicator body, wherein a connecting tube part connected to a liquid outlet part at the tip of the syringe is formed on the base end side of the applicator body, an extending tube part communicated with the connecting tube part is formed on the tip end side of the applicator body, and the needle array, in which a plurality of the microneedles are arranged in an array, is attached to the tip of the extending tube part. a tension ring is attached to the tip of the applicator body so as to protrude from the tip and to be movable in the longitudinal direction of the applicator body; a biasing member is provided inside the applicator body for biasing the tension ring toward the tip of the applicator body; a guide recess is formed on the inner surface of the tip of the applicator body along the longitudinal direction of the applicator body; and a guide protrusion formed on the outer periphery of the tension ring is inserted into the guide recess so as to be movable in the longitudinal direction of the connecting tube portion along the inner surface of the tip of the applicator body .

(2) In the microneedle array puncture device according to this embodiment, it is preferable that the biasing member is a coil spring wound around the outer periphery of the extending cylindrical portion.

(3) In the microneedle array puncture device according to this embodiment, it is preferable that the biasing member is a resin rubber ring wrapped around the outer periphery of the extending tubular portion.

( 4 ) In the microneedle puncture device according to this embodiment, it is preferable that an anti-slip member is attached to the tip surface of the tension ring either integrally or separately.

According to the present invention, when injecting a liquid contained in a syringe into the skin using a microneedle, the tension ring protruding from the tip of the applicator body is pressed against the skin, and a part of the skin is pressed in with the tip of the tension ring, thereby raising the skin inside the tension ring into a convex shape and maintaining the skin in an expanded state.
From this state, when the tip of the syringe is brought closer to the skin, the microneedle can be punctured into the skin. Since the skin in a convex, expanded state is less likely to escape even when punctured by the microneedle, even a microneedle with a length and diameter of 1 mm or less can be accurately punctured into the skin at the desired location and depth.
Therefore, when administering insulin or anesthesia stored in a syringe, injecting various vaccines, or injecting liquids such as beauty serums and other medicines subcutaneously using a microneedle, reliable and accurate injection can be achieved.

In addition, if the microneedle is made of resin, there is a risk of it breaking. However, the applicator body and tension ring protect the microneedle during storage and transportation other than the puncture operation, when removing it from the packaging container, and during handling for puncture, preventing the microneedle from breaking when handled other than during puncture.

By pushing the tension ring at the tip of the applicator body into the applicator body against the elastic force of the biasing member, the microneedle can be brought close to the skin and punctured. In this case, by pushing the syringe into the skin while holding it perpendicular to the skin, the microneedle can be punctured perpendicular to the skin. This allows the microneedle to puncture the skin to the required depth, and liquid to be injected accurately to the required depth.

In the present invention, a trumpet-shaped expansion member made of resin is attached to the tip side of the applicator body so that it extends forward and around the microneedle. This allows the tip of the trumpet-shaped expansion member to be pressed against the skin before the microneedle when puncturing with the microneedle, spreading the skin. By puncturing the skin in this state, the microneedle can be prevented from slipping out of the skin, allowing the microneedle to be inserted accurately and reliably.

FIG. 1 is a partial cross-sectional view of a microneedle array puncture device according to a first embodiment of the present invention. FIG. 10 is a partial cross-sectional view showing the tip of the microneedle array puncture device in contact with the skin. FIG. 10 is a partial cross-sectional view showing a state in which the tip of the microneedle array puncture device is pressed against the skin to stretch the skin. FIG. 10 is a partial cross-sectional view showing the state in which the needles of the microneedle array have been punctured into the skin stretched by the tip of the microneedle array puncturing device. FIG. 10 is a partial cross-sectional view of a microneedle array puncture device according to a second embodiment of the present invention. FIG. 10 is a partial cross-sectional view showing the tip of the microneedle array puncture device in contact with the skin. FIG. 10 is a partial cross-sectional view showing a state in which the tip of the microneedle array puncture device is pressed against the skin to stretch the skin. FIG. 10 is a partial cross-sectional view showing the state in which the needles of the microneedle array have been punctured into the skin stretched by the tip of the microneedle array puncturing device. FIG. 10 is a partial cross-sectional view of a microneedle array puncture device according to a third embodiment of the present invention. FIG. 10 is a partial cross-sectional view showing the tip of the microneedle array puncture device in contact with the skin. FIG. 10 is a partial cross-sectional view showing the state in which the needles of the microneedle array have been punctured into the skin stretched by the tip of the microneedle array puncturing device. FIG. 10 is a partial cross-sectional view of a microneedle array puncture device according to a fourth embodiment of the present invention. FIG. 10 is a partial cross-sectional view showing the tip of the microneedle array puncture device in contact with the skin. FIG. 10 is a partial cross-sectional view showing the state in which the needles of the microneedle array have been punctured into the skin stretched by the tip of the microneedle array puncturing device. FIG. 10 is a partially enlarged cross-sectional view showing the state in which the needles of the microneedle array have been punctured into the skin stretched by the tip of the microneedle array puncturing device. FIG. 1 is a partial cross-sectional view showing a configuration in which a microneedle array and a needle holder applied to a microneedle array puncture device are integrally molded. FIG. 1 is a partial cross-sectional view showing a configuration in which a microneedle array and a needle holder are bonded together and are applied to a microneedle array puncture device. FIG. 10 is a cross-sectional view showing a second form of a tension ring applied to a microneedle array puncture device. FIG. 10 is a cross-sectional view showing a third form of a tension ring applied to a microneedle array puncture device. FIG. 10 is a cross-sectional view showing a second example of a microneedle array applied to a microneedle array puncture device. FIG. 10 is a cross-sectional view showing a third example of a microneedle array applied to a microneedle array puncture device. FIG. 10 is a cross-sectional view showing a fourth example of a microneedle array applied to a microneedle array puncture device. FIG. 10 is a cross-sectional view showing a fifth example of a microneedle array applied to a microneedle array puncture device.

First Embodiment
The microneedle array puncture device according to the present invention will be described in detail below based on a first embodiment, but the present invention is not limited to the embodiment described below.
Fig. 1 shows a microneedle array puncture device according to the first embodiment. The microneedle array puncture device A of this embodiment is attached to the tip side of a syringe 1, which is positioned with its tip facing downward and facing an object F to be punctured, such as skin, as shown in Fig. 1. The microneedle array puncture device A has a cylindrical applicator main body 3 attached to a liquid dispensing tube (liquid dispensing part) 2 for a medicinal solution or the like that protrudes from the tip end of the syringe 1, and a needle array 5 is attached to the center of the tip end of this applicator main body 3.

The needle array 5 of this embodiment comprises a disk-shaped base 5a molded from resin and a plurality of microneedles 5b integrally molded from resin onto the surface of the base 5a. The microneedles 5b are formed to a length of 1 mm or less, for example, approximately 200 μm to 800 μm, and a thickness of 1 mm or less. The microneedles 5b are, for example, needle-shaped with gradually tapered tips and arranged in an array. Although not shown in FIG. 1, liquid outlet holes are formed inside the microneedles 5b, extending from their bottoms to their tips. Furthermore, a circular recess in plan view, slightly smaller than the radius of the backside of the base 5a, is formed on the backside of the base 5a, and the liquid outlet holes of the microneedles 5b are connected to this recess. It is also possible to omit the recess provided in the base 5a and have the liquid outlet holes of the microneedles 5b penetrate the thickness of the base 5a and reach the backside of the base 5a.
The microneedles 5b are arranged in an array on the surface of the base 5a, with several to several tens of microneedles 5b spaced apart at predetermined intervals.

Various synthetic resins can be used as the material for forming the needle array 5. When the needle array 5 is formed from a synthetic resin, the base 5 a and the microneedles 5 b may be an integrally molded resin product.
Examples of synthetic resins include general-purpose synthetic resins, medical synthetic resins, and cosmetic synthetic resins. More specifically, the synthetic resin may be at least one selected from the group consisting of polyethylene, polypropylene, polystyrene, polyamide, polycarbonate, cyclic polyolefin, polylactic acid, polyglycolic acid, polycaprolactone, acrylic, urethane resin, aromatic polyether ketone, and epoxy resin. The synthetic resin may also be a copolymer of two or more resins included in the above-mentioned resin group. Each component of the needle array 5 may be formed from a different resin. The needle array 5 may also be formed from a biodegradable resin such as PGA resin (polyglycolic acid resin). The microneedles 5b may be formed from a metal material such as stainless steel.

The syringe 1 is cylindrical and comprises a cylindrical body 6 having an opening at one end and a small-diameter liquid-dispensing cylinder 2 formed on the end wall 1a of the other end, and in Fig. 1 the syringe 1 is depicted in an upright position with the liquid-dispensing cylinder 2 facing downward. An outer cylindrical portion 7 is formed integrally with the cylindrical body 6 at the lower end thereof so as to surround the periphery of the liquid-dispensing cylinder 2, and an internal thread portion 8 is formed on the inner circumferential surface of the outer cylindrical portion 7. The applicator body 3 is provided so as to thread onto this internal thread portion 8.
The applicator body 3 shown in Fig. 1 comprises a cylindrical tube wall portion 10 having an inner diameter slightly larger than that of the outer tube portion 7, a partition wall portion 11 formed in the center of the height (length) direction of the tube wall portion 10, a connecting tube portion 12 formed on the upper side of the partition wall portion 11, and an extending tube portion 13 formed on the lower side of the partition wall portion 11. In the applicator body 3 attached to the tip of the syringe 1 as shown in Fig. 1, the connecting tube portion 12 is formed on the base end side of the applicator body 3, and the extending tube portion 13 is formed on the tip end side of the applicator body 3.

The connecting tube portion 12 has an inner diameter that allows it to be fitted onto the liquid dispensing tube 2. In the configuration shown in Figure 1, the liquid dispensing tube 2 is formed slightly tapered at the end, so the connecting tube portion 12 is formed slightly flared upward. The connecting tube portion 12 is detachably threaded onto the liquid dispensing tube 2 by engaging the peripheral protrusion 15 formed at its tip with the internal thread portion 8 of the outer tube portion 7. As shown in Figure 1, when the upper end of the connecting tube portion 12 is threaded to reach the innermost end of the internal thread portion 8, the lower end of the outer tube portion 7 is formed to a length that reaches the lower side of the connecting tube portion 12, and in this state, the upper end of the tube wall portion 10 is formed to a length that reaches the center of the height (length) of the outer tube portion 7.

The extending tubular portion 13 is formed slightly shorter than the connecting tubular portion 12 and is formed into a cylindrical shape with approximately the same inner diameter and the same outer diameter from its top to its bottom. The extending tubular portion 13 is formed slightly thicker than the connecting tubular portion 12, and a biasing member 17 made of a coil spring is wound around the outer periphery of the extending tubular portion 13. In addition, a tension ring 18 is provided on the lower end (tip) side of the extending tubular portion 13.
In the state shown in Figure 1, the tension ring 18 is inserted with its upper side inside the tubular wall portion 10 and its lower side protruding downward (outward) from the lower end of the tubular wall portion 10, so that it is inserted between the lower end of the extending tubular portion 13 and the lower end of the tubular wall portion 10 so as to be freely movable in the lengthwise direction of the extending tubular portion 13.
A concave curved surface 18c is formed on the lower side of the outer circumferential surface of the tension ring 18 so that the tip end 18b of the tension ring 18 gradually becomes thinner. By providing the concave curved surface 18c on the outer circumferential surface of the tension ring 18, the tip end of the tension ring 18 has a slightly tapered shape.

A guide recess 19 of a predetermined depth and length is formed on the inner peripheral surface of the lower end of the cylindrical wall portion 10 along the length (height) direction of the cylindrical wall portion 10. A guide protrusion 18a formed on the outer periphery of the upper part of the tension ring 18 is inserted into the guide recess 19 to define the range of vertical movement of the tension ring 18, thereby preventing it from coming loose.
The guide recess 19 is formed in the cylindrical wall portion 10 from a position slightly below the formation position of the partition wall portion 11 to near the lower end of the cylindrical wall portion 10. The height of the tension ring 18 is formed slightly lower than the height from the formation position of the partition wall portion 11 to the lower end (tip) of the cylindrical wall portion 10.

In addition, a biasing member 17 made of a coil spring is provided on the tension ring 18. The free height of the biasing member 17 is set slightly lower than the distance from the lower end of the partition wall portion 11 to the lower end of the guide recess 19.
When the microneedle array puncture device A is facing downward as shown in Figure 1, the tension ring 18 comes to a standstill when the guide protrusion 18a is lowered to near the bottom end of the guide recess 19, and the biasing member 17 is positioned between the partition wall portion 11 and the tension ring 18.

In the above-described state, the tension ring 18 has its tip 18b protruding outward (downward) by a predetermined length from the tip (lower end) of the cylindrical wall 10. In the example of Fig. 1, when the microneedle array puncture device A is facing downward, the concave curved surface 18c and the tip 18b protrude outward from the tip of the cylindrical wall 10.
Furthermore, when the tension ring 18 is raised so as to be pushed into the interior of the cylindrical wall portion 10, the biasing member 17 exerts an elastic repulsive force to generate a force that resists the rising of the tension ring 18.

The needle array 5 described above is attached to the tip surface of the extending tubular portion 13 by a joining method such as adhesive. As described above, a recess is formed in the center of the back surface of the base 5a, and the needle array 5 is fixed to the tip surface of the extending tubular portion 13 so that this recess communicates with the internal flow path of the extending tubular portion 13.

The microneedle array puncture device A is used to administer insulin or anesthesia, administer various vaccines, or inject liquids such as beauty serums and other medicines subcutaneously.
To use the microneedle array puncture device A, the syringe 1 is filled with the necessary liquid such as a medicinal solution, a plunger (not shown) is inserted into the opening of the syringe 1, and the tip 18b of the tension ring 18 is faced downward and opposed to the object F to be punctured, such as skin, as shown in Figure 1.
Next, as shown in Fig. 2, tip 18b of tension ring 18 is abutted against the surface of object F to be punctured, and as shown in Fig. 3, tip 18b of tension ring 18 is pressed against the surface of object F to be punctured. This operation allows tip 18b of tension ring 18 to be pressed so as to bite into the surface of object F. In the state shown in Fig. 3, tension ring 18 bends biasing member 17, generating a certain biting force due to its elastic force, while also applying tension to the surface of the skin inside tension ring 18, causing the surface of the skin to rise convexly.

By further pushing the syringe 1 toward the surface of the skin that has been tensioned and raised into a convex shape, the microneedles 5b can be reliably punctured into the skin. Also, by pushing the plunger into the syringe 1, the liquid in the syringe 1 can be reliably injected into the skin via the microneedles 5b. Because human and animal skin is soft, if an attempt is made to puncture only the microneedles 5b directly into the coating, skin escape may occur, and the microneedles 5b may not be able to puncture the skin sufficiently.
The surface of human skin is said to be about 10 to 15 μm thick, which is the stratum corneum, and underneath that is the epidermis, which is about 200 μm thick, and underneath that is the dermis, which is about 1 to 3 mm thick.
For example, if the microneedles 5b are about 300 to 800 μm long, it is possible to reliably inject a liquid such as a drug solution into the epidermis or dermis. Furthermore, because each microneedle 5b is extremely thin, it is possible to inject a liquid subcutaneously without causing pain to the user.

The microneedles 5b are extremely thin, with a thickness and length of less than 1 mm, and if they are made of resin, they may easily break. In contrast, with the microneedle array puncture device A shown in Figure 1, the tension ring 18 and applicator body 3 surround and protect the microneedles 5b, making it less likely that problems such as breakage of the microneedles 5b will occur during handling other than when injecting liquid.

Furthermore, if the microneedles 5b have the aforementioned thinness and length and are made of resin, there is a risk that the microneedles 5b may break if the patient moves their arm while they are punctured into the skin. In this regard, if the tension ring 18 is used to press and expand the skin, creating a convex protrusion before puncturing, there is less risk of the microneedles 5b shifting position and breakage of the microneedles 5b can be prevented. Furthermore, when the elastic force of the biasing member 17 is used to press the tension ring 18 against the skin, the elastic force of the biasing member 17 allows the tension ring 18 to be pressed evenly against the skin. Pressing the tension ring 18 against the skin with even force allows the microneedles 5b to be inserted at an ideal angle close to a right angle to the skin surface.

In addition, when the position where the microneedles 5b are to be punctured is the skin directly above a bone, if an attempt is made to puncture the skin while simply applying a tensile force to the skin, a sufficient thickness of skin cannot be secured at the position where the microneedles 5b are to be punctured, and the puncture ability of the microneedles 5b may become unstable. In contrast, if the microneedles 5b are configured to puncture the skin while raising it convexly, the necessary thickness of skin can be secured reliably, which contributes to improving the puncture ability of the microneedles 5b.
Therefore, when administering insulin or anesthesia stored in a syringe, administering various vaccines, or injecting liquids such as beauty serums and other medicines subcutaneously using a microneedle, injection can be performed reliably and accurately.

If the microneedle 5b were made of resin, there would be a risk of it breaking. However, the applicator body 3 and tension ring 18 protect the microneedle 5b during storage and transportation other than the puncture operation, when removing from the packaging container, and during handling for puncture, so breakage of the microneedle 5b can be prevented during handling other than puncture.

Second Embodiment
FIG. 5 shows a microneedle array puncture device according to the second embodiment.
The microneedle array puncture device B of this embodiment is attached to the tip side of a syringe 1 that faces the skin or other object to be punctured F with its tip facing downward, as shown in Figure 5. The microneedle array puncture device B has a cylindrical applicator main body 3 attached to a liquid dispensing tube (liquid dispensing part) 2 for a medicinal solution or the like that protrudes from the tip end of the syringe 1, and a needle array 5 is attached to the center of the tip end of this applicator main body 3 via a needle holder 20.

The applicator body 3 has the same structure as the applicator body 3 of the first embodiment. A cap-shaped needle holder 20 is fitted onto the tip of the extending tubular portion 13 of the applicator body 3. The needle holder 20 has a peripheral wall portion 21a formed on the outer periphery of a ring-shaped base plate 21, and an ejection hole 21c formed in the center of the base plate 21. The inner diameter of the ejection hole 21c is formed to be equal to the inner diameter of the extending tubular portion 13.
The needle holder 20 is attached to the outer surface of the substrate 21 by a fixing means such as adhesive so as to close the opening of the injection hole 21c, and the liquid contained in the syringe 1 can be injected through the liquid injection tube 2, the extension tube portion 13, the needle holder 20, and the microneedle 5b.
The other configurations are the same as those of the first embodiment, so the same components are given the same reference numerals and detailed description thereof will be omitted.

The microneedle array puncturing device B of the second embodiment shown in FIG. 5 can also be used for the same purpose as the microneedle array puncturing device A of the first embodiment.
That is, from the state shown in Fig. 6, the tip 18b of the tension ring 18 is pressed into the skin as shown in Fig. 7, and the microneedles 5b are punctured into the skin at right angles, thereby achieving the purpose of injecting a medicinal solution, etc. With regard to other effects, the microneedle array puncturing device B can also obtain effects equivalent to those of the microneedle array puncturing device A of the first embodiment.

"Third embodiment"
FIG. 9 shows a microneedle array puncture device according to the third embodiment.
The microneedle array puncture device C of this embodiment is attached to the tip side of a syringe 1 that faces the skin or other object to be punctured F with its tip facing downward, as shown in Fig. 9. The microneedle array puncture device C has a cylindrical applicator main body 3 attached to a liquid dispensing tube (liquid dispensing part) 2 for a medicinal solution or the like that protrudes from the tip end of the syringe 1, and has a structure in which a needle array 5 is attached to the center of the tip end of this applicator main body 3, which is equivalent to the structure of the first embodiment.
In the microneedle array puncture device C of the third embodiment, the biasing member 22 arranged inside the applicator body 3 and on the outer periphery of the extending cylindrical portion 13 is formed into a cylindrical shape made of an elastic material. Since the other configurations are the same as those of the microneedle array puncture device A of the first embodiment, the same components are given the same reference numerals and their description will be omitted.

The microneedle array puncturing device C of the third embodiment shown in FIG. 9 can also be used for the same purpose as the microneedle array puncturing device A of the first embodiment.
That is, from the state shown in Fig. 10, the tip 18b of the tension ring 18 can be pressed into the skin as shown in Fig. 11, and the microneedles 5b can be punctured perpendicularly into the skin to achieve the purpose of injecting a medicinal solution. In the third embodiment, a cylindrical biasing member 22 made of an elastic body is provided instead of the biasing member 17 of the first embodiment, which was made of a coil spring. Therefore, when the tip 18b of the tension ring 18 is pressed into the skin, the cross section of the biasing member 22 bends into a C-shape as shown in Fig. 11, and the entire circumference of the tip 18b of the tension ring 18 is pressed against the skin with uniform pressure, thereby achieving the purpose.
The microneedle array puncturing device C of the third embodiment can also obtain other effects equivalent to those of the microneedle array puncturing device A of the first embodiment.

Fourth Embodiment
FIG. 12 shows a microneedle array puncture device according to the fourth embodiment.
The microneedle array puncture device D of this embodiment is attached to the tip side of a syringe 1 that faces the skin or other object to be punctured F with its tip facing downward, as shown in Fig. 12. The microneedle array puncture device D has a cylindrical applicator main body 30 attached to a liquid dispensing tube (liquid dispensing part) 2 for a medicinal solution or the like that protrudes from the tip end of the syringe 1, and the needle array 5 is attached to the center of the tip end of this applicator main body 30, which is similar in structure to the first embodiment.

In the microneedle array puncture device D of the fourth embodiment, the applicator body 30 has a cylindrical wall portion 31 that is about half the height of the cylindrical wall portion 10 of the applicator body 3 of the first embodiment. A partition wall portion 11 is formed at the bottom of the cylindrical wall portion 31, but the portion that corresponds to the lower side of the cylindrical wall portion 10 of the first embodiment, which was provided below the partition wall portion 11, has been omitted.
In the fourth embodiment, only the extending tubular portion 13 is formed to protrude below the partition wall portion 11. The height (length) and thickness of the extending tubular portion 13 are the same as those of the extending tubular portion 13 in the first embodiment.

A downward-facing trumpet-shaped thick-walled expansion member (rubber ring) 33 is attached to the outer periphery of this extending cylindrical portion 13 .
This expansion member 33 is made entirely of an elastic material such as rubber, and consists of a cylindrical fixed portion 33a fitted onto the outer periphery of the extending tubular portion 13, and an expansion portion 33b located below the fixed portion 33a and expanding into a trumpet shape as it moves downward toward the extending tubular portion 13.
12, the outer diameter of the expansion portion 33b is approximately 1.5 times larger than the outer diameter of the extending tubular portion 13. The thickness of the expansion member 33 is approximately the same as the thickness of the extending tubular portion 13.

The fixing portion 33a has the same inner diameter from its upper end to its lower end, and is fitted onto the outer periphery of the extending tubular portion 13. Ring protrusions 33c and 33d are formed adjacent to each other on the inner surface of the expanding portion 33b, and extend around the entire inner periphery of the expanding member 33. The ring protrusions 33c and 33d are both ridges with a triangular pyramid shape in cross section, and the ring protrusion 33d on the outer periphery is formed with an inner diameter that is slightly larger than the ring protrusion 33c on the inner periphery.
The other configurations are the same as those of the microneedle array puncture device A of the first embodiment, so the same components are given the same reference numerals and their description will be omitted.

The microneedle array puncturing device D of the fourth embodiment shown in FIG. 12 can also be used for the same purpose as the microneedle array puncturing device A of the first embodiment.
That is, from the state shown in FIG. 13, the expansion member 33 is pressed into the skin as shown in FIG. 14, and the microneedles 5b are inserted perpendicularly into the skin surface, thereby achieving the purpose of injecting a medicinal solution.
The fourth embodiment is characterized in that, instead of the biasing member 17 of the first embodiment which is made up of a coil spring, a trumpet-shaped thick-walled expansion member 33 made of an elastic material such as rubber is provided.

When syringe 1 is pushed perpendicularly into the skin and the inner surface of expansion portion 33b is pressed against the surface of the skin, as shown in Figures 14 and 15, ring protrusions 33c and 33d on the inner surface of expansion portion 33b can be pressed against the surface of the skin, and a force can be applied so that ring protrusions 33c and 33d spread the pressed skin outward and press the skin with ring protrusions 33c and 33d to form annular groove portion 38 on the surface of the skin as shown in Figure 14.
This allows the surface of the skin inside the ring protrusion 33c to be raised in a convex shape, applying tension to the skin surface. The microneedles 5b can then be inserted at right angles into this raised, convex skin surface, allowing for the injection of a medicinal solution or other purposes.
The microneedle array puncturing device D of the fourth embodiment can also obtain other effects equivalent to those of the microneedle array puncturing device A of the first embodiment.

Figure 16 shows an example of the needle array 5 and needle holder 20 of the second embodiment described based on Figures 5 to 8, in which the needle array 5 and needle holder 20 are integrally molded from the same resin, and Figure 17 shows a configuration in which the needle array 5 and needle holder 20 are formed separately and then integrated by a joining means such as adhesive.
In the base 5a of the needle array 5 shown in Figure 17, adhesive can be applied to the outer periphery of the back side (upper side), and the back side of the base 5a can be adhered to the lower side of the substrate 21 of the needle holder 20, thereby integrating the two.

Figure 18 shows an example in which an anti-slip member (anti-slip ring) 40 having an anti-slip uneven surface is provided on the tip surface of the tip portion 18b of the tension ring 18 provided on the microneedle array puncture devices A, B, and C of the first to third embodiments.
By providing the anti-slip member 40, for example, when the tension ring 18 is pressed against the puncture target F as shown in Figures 2 and 3, lateral slippage can be prevented. Therefore, needle breakage of the microneedle 5b can be prevented when puncturing the skin.

Figure 19 shows an example in which an anti-slip material (anti-slip ring) 41 having an anti-slip uneven surface is attached to the tip surface of the tip portion 18b of the tension ring 18 provided on the microneedle array puncture devices A, B, and C of the first to third embodiments by means of attachment such as adhesion or fitting.
By providing the anti-slip member 41, for example, when the tension ring 18 is pressed against the puncture target F as shown in Figures 2 and 3, lateral slippage can be prevented. Therefore, needle breakage of the microneedle 5b can be prevented when puncturing the skin.

Figure 20 shows a second example in which a needle array 5 is attached to the tip of the extending tubular portion 13 by adhesive, and Figure 21 shows a third example in which a cap-shaped needle holder 20 equipped with a needle array 5 is attached to the tip of the extending tubular portion 13.
When attaching the needle array 5 to the extending tubular portion 13 using the needle holder 20, a structure can be adopted in which an external thread portion 13a is formed at the tip of the extending tubular portion 13, and an internal thread portion 21b that can be threaded onto this external thread portion 13a is formed on the inner surface of the peripheral wall portion of the needle holder 20, as in the fourth example shown in Figure 22.
By employing the configuration shown in FIG. 22, the needle holder 20 can be attached to the front end of the extending tubular portion 13 by threading the outer thread portion 13a into the inner thread portion 21b.

22, the outer thread portion 13a and the inner thread portion 21b can be unthreaded, and the needle holder 20 and the needle array 5 can be easily removed. After removing the needle holder 20 and the needle array 5, they can be replaced with new, unused needle holders 20 and needle arrays 5.
By adopting the structure of FIG. 22, if the attached needle array 5 is damaged before use, it can be replaced with a new, unused needle holder 20 and needle array 5 .

Figure 23 shows a fifth example of attaching a needle array 5 to the extending tubular portion 13 using a needle holder 20.As shown in Figure 23, a structure can be adopted in which multiple hook portions 13b are intermittently formed around the tip of the extending tubular portion 13, and multiple groove portions 21d that can fit into these hook portions 13b are intermittently provided on the inner surface of the peripheral wall portion 21a of the needle holder 20.
Although not shown in Figure 23, a groove is formed in the opening of the peripheral wall portion 21a to introduce the hook portion 13b into the recessed groove portion 21d, and the hook portion 13b can be freely inserted into the recessed groove portion 21d through this groove, thereby allowing the needle holder 20 to be attached to the extending tubular portion 13.

By engaging the hook portion 13b of the extending cylindrical portion 13 with the recessed groove portion 21c shown in FIG. 23, the needle array 5 can be easily fitted and attached with a single touch using the needle holder 20.
23, the needle holder 20 equipped with the needle array 5 can be easily removed with a single touch. Therefore, if a problem occurs with the attached needle array 5, it can be easily replaced with a new, unused needle holder 20 and needle array 5.

A, B, C, D...Microneedle array puncture device, 1...syringe, 2...liquid dispensing tube (liquid dispensing portion), 3...applicator body, 5...needle array, 5a...base, 5b...microneedle, 6...tube body, 7...outer tube portion, 8...internal thread portion, 10...tube wall portion, 11...partition wall portion, 12...connecting tube portion, 13...extending tube portion, 17...biasing member, 18...tension ring, 18a...guiding protrusion portion, 18b...tip portion, 19...guiding recess portion, 20...needle holder, 22...biasing member, 30...applicator body, 33...expansion member (rubber ring), 40, 41...non-slip material.

Claims (4)

A microneedle array puncture device comprising: a cylindrical applicator body that is detachably attached to the tip of a syringe containing a liquid; and a needle array that is attached to the tip side of the applicator body and has microneedles;
a connecting tube portion connected to the liquid outlet portion at the tip of the syringe is formed on the base end side of the applicator body, an extending tube portion communicated with the connecting tube portion is formed on the tip end side of the applicator body, the needle array having a plurality of the microneedles arranged in an array is attached to the tip end of the extending tube portion, a tension ring is attached to the tip end of the applicator body so as to protrude from the tip end and to be movable in the length direction of the applicator body, and a biasing member is provided inside the applicator body to bias the tension ring toward the tip end side of the applicator body,
A microneedle array puncture device characterized in that a guide recess is formed on the inner surface of the tip of the applicator body along the longitudinal direction of the applicator body, and the tension ring has a guide protrusion formed on its outer periphery that is inserted into the guide recess and is inserted so as to be freely movable in the longitudinal direction of the connecting tube portion along the inner surface of the tip of the applicator body. The microneedle array puncture device according to claim 1, characterized in that the biasing member is a coil spring wound around the outer periphery of the extending cylindrical portion. The microneedle array puncture device according to claim 1, characterized in that the biasing member is a resin rubber ring wrapped around the outer periphery of the extending tubular portion. The microneedle array puncture device according to any one of claims 1 to 3 , characterized in that an anti-slip member is attached to the tip surface of the tension ring either integrally or separately .