JP2012157406A - Microneedle, microneedle array, and microneedle array device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a microneedle that can be easily thrust into skin diagonally, can strike a balance between the relief of pain to a patient and the prevention of leakage of a chemical, and can be easily manufactured.SOLUTION: The microneedle includes: a needle body having a cuspate shape; a plane part disposed at an outer peripheral surface of the needle body; and a flow path prepared in an inside of the needle body, opened to the plane part, and opened to the rear end side, thereby the plane part comes in contact with a cutaneous inside when the microneedle is injected in the cutaneous part, and the chemical supplied to the flow path will be discharged into the plane part side, the injection of the chemical can be efficiently performed.

Description

  The present invention relates to, for example, a microneedle, a microneedle array, and a microneedle array device that perform injection by piercing the skin, and in particular, can be easily pierced while the microneedle is inclined with respect to the skin surface, and The present invention relates to a device devised so that the liquid can be injected into the skin without flowing out.

  Conventionally, as a microneedle having a through hole, a microneedle described in Patent Document 1 has been known. In the case of the microminiature needle described in Patent Document 1, a substantially conical microneedle is formed on a substrate, and an inner peripheral surface that opens at a side surface of the microneedle and passes through the central axis of the microneedle. A through-hole having a flow path is formed as a flow path.

However, since the through hole is opened in the direction of movement of the microneedle in the microminiature needle described in Patent Document 1, there is a possibility that the tissue enters the through hole when pierced into the skin. For this reason, the through hole is blocked by the tissue, which hinders the injection of the chemical solution.
Moreover, in the microminiature needle described in Patent Document 1, it is extremely difficult to provide a complicated flow path while maintaining strength because of its manufacturing method and shape.

  In addition to the micro needle described in Patent Document 1, the micro needle unit 101 shown in FIGS. 20 (a) and 20 (b) has been proposed (Japanese Patent Application Nos. 2010-147305, 2010). Patent application by the patent applicant, unpublished). The microneedle unit 101 is provided with a substantially quadrangular pyramidal microneedle 101a. A slit-like outlet 101b is formed on the tip side of the microneedle 101a, and the outlet 101b communicates with a channel 101c formed in the microneedle unit 101. In addition, the microneedle unit 101 has a configuration in which divided elements 101d and 101e obtained by equally dividing the microneedle unit 101 are bonded to each other, and a gap generated by non-adhering only the tip side of the microneedle 101a is described above. The outlet 101b is used.

JP 2003-88514 A

The conventional configuration has the following problems.
That is, in the case of the invention described in Japanese Patent Application No. 2010-147305, the outlet 101b is a gap formed by the non-adhered portions of the dividing elements 101d and 101e, so that the microneedle 101a is pierced into the skin. In this case, there is a problem that the microneedle 101a is pressed by the surrounding tissue and the outflow port 101b is difficult to open.
There is also a problem that it is difficult to form the microneedle unit 101 by bonding the split elements 101d and 101e that are symmetrical in this way. That is, in order to accurately manufacture the microneedle 101 in which the outlet 101b and the flow path 101c are formed, it is necessary to accurately bond the split elements 101d and 101e having an accurate symmetrical shape, and Therefore, high dimensional accuracy is required for both of the dividing elements 101d and 101e. As a result, it becomes difficult to manufacture the microneedle 101.

  Moreover, in order to prevent the chemical solution from flowing out from the opening of the microneedle to the skin surface, it is necessary to put the opening completely into the skin. For that purpose, it is necessary to allow many parts of the microneedle to enter the skin. . At this time, if the microneedle 101a is stabbed perpendicularly to the skin 103, the skin 103 is pressed and deformed by the microneedle 101a as shown in FIG. Therefore, there is a problem that the microneedle 101 a cannot be sufficiently inserted into the skin 103.

  In order to solve such a problem and not to give pain to the patient, for example, as shown in FIG. 20B, it is preferable to pierce the microneedle 101a obliquely with respect to the surface of the skin 103. Conceivable. However, in that case, the angle of the ridgeline of the microneedle 101 a is almost parallel to the skin 103, so that it becomes slippery. Eventually, the microneedle 101 a can be sufficiently inserted into the skin 103. There was a problem that I could not.

  For such a problem, for example, a microneedle unit 105 as shown in FIG. 21 can be considered. The microneedle unit 105 is also provided with a microneedle 105a. The microneedle 105a has a shape obtained by equally dividing the microneedle 101a of the microneedle unit 101 described above into two. Therefore, even when the microneedle 105a is pierced in the same manner as the microneedle 101a shown in FIG. 20B, the divided surface of the microneedle 105a is compared with the case shown in FIG. 20B. As a result, the tip of the microneedle 105a becomes difficult to slip on the surface of the skin 103. Further, a groove 105b is formed on the dividing surface of the microneedle 105a. A channel 105c is provided in the microneedle unit 105, and the channel 105c communicates with the groove 105b of the microneedle 105a. The base end side of the microneedle 105a of the groove 105b is closed by a cover 105d, and the opening on the tip side of the groove 105b is an outlet 105e.

According to the microneedle unit 105, the microneedle 105a has a surface on which the groove 105b is formed, and a complicated flow path can be formed by forming a groove communicating with the groove 105b on this surface. .
However, since the outlet 105e is formed at the tip of the microneedle 105a by closing the groove 105b with the cover 105d, the cover 105d is peeled off when the microneedle 105a is pierced into the skin. There is a possibility that. In addition, the cover 105d may cause resistance when the microneedle 105a is pierced into the skin, making it difficult to pierce. Further, it is difficult to evenly bond the cover 105d with sufficient adhesive strength over the entire surface, and there is a possibility that the chemical solution leaks from other than the outlet 105e. Also, the groove 105b and the groove formed in the microneedle 105a so as to communicate with the groove 105b are fine, and it is difficult to bond the cover 105d so as not to fill them.

  The present invention has been made based on such points, and the object of the present invention is that the microneedle can be pierced obliquely with respect to the skin, thereby reducing pain to the patient and preventing chemical leakage. It is another object of the present invention to provide a microneedle, a microneedle array, and a microneedle array device that are compatible with each other and can be easily manufactured.

In order to solve the above-mentioned problem, a microneedle described in claim 1 is provided inside a needle body having a pointed shape, a flat portion provided on an outer peripheral surface of the needle body, and the needle body. And a flow path opened to the flat portion and opened to the rear end side.
The microneedle described in claim 2 is the microneedle according to claim 1, wherein the flow path is opened in the inner flow path opened on the rear end side of the needle body and in the flat portion. It is comprised from the groove | channel, the said internal flow path, and the communicating hole drilled by the laser processing which connected the said groove | channel.
The microneedle according to claim 3 is the microneedle according to claim 1, wherein the needle body is divided into two parts composed of two split elements, and the two split elements are combined. The dividing and mating surfaces of one of the dividing elements exposed in the above function as the flat portion, and the one dividing element opens to the dividing and mating surface side and is also opened to the rear end side of the needle body. A groove is formed, and the flow path groove is closed by combining the other divided element and the one divided element, whereby the flow path is formed.
Further, the microneedle described in claim 4 is the microneedle according to claim 3, wherein the other split element is engaged with a projection for engaging in a flow channel groove provided in the one split element. Is provided, and the channel is formed by engaging the engaging convex portion in the channel groove.
Moreover, the microneedle described in Claim 5 is the microneedle in any one of Claims 1-4. WHEREIN: The convex part is provided in the front end side of the said plane part, It is characterized by the above-mentioned. Is.
Further, the microneedle described in claim 6 is the microneedle according to any one of claims 1 to 5, wherein the planar portion has a minute portion communicating with the opening portion on the planar portion side of the flow path. A groove is formed.
The microneedle array according to claim 7 includes a case, and the microneedle according to any one of claims 1 to 6, which is protruded and arranged to be inclined with respect to the surface of the case. It is characterized by comprising.
The microneedle array according to claim 8 is the microneedle array according to claim 7, wherein the case has the same number of through-holes as the microneedles, and the microneedle has the shape according to claim 4. A microneedle, wherein the other split element is protruded and formed integrally with the case from the outer edge of the through hole, and the one split element passes through the through hole and is installed in the case It is provided in the unit.
The microneedle array device according to claim 9 is provided with a microneedle array according to claim 7 or 8 having a guide portion formed on a side surface thereof, and a bottom plate having the same number of through-holes as the microneedles. And a guide jig formed by a guide plate standing from the bottom plate and engaged with the guided portion to guide the microneedle array, the microneedle array being the guide The microneedle is moved by a jig so as to penetrate the through hole and protrude toward the anti-guide plate side of the bottom plate.
The microneedle array device according to claim 10 is the microneedle array device according to claim 9, wherein the guide portion includes an inclined guide portion that guides the microneedle array in an oblique direction, and the microneedle array device. And a horizontal guide portion for horizontally guiding the guide.
The microneedle array device according to claim 11 is the microneedle array device according to claim 10, wherein the inclined guide portion guides the microneedle array along a central axis of the microneedle. It is characterized by.
A microneedle array device according to a twelfth aspect is the microneedle array device according to any one of the ninth to eleventh aspects, wherein a slider to be engaged with the microneedle array is provided. The microneedle array is moved through the slider.

As described above, the microneedle according to claim 1 has a flat portion provided on the outer peripheral surface of the needle body, and one end of the flow path is opened in the flat portion. Therefore, when the microneedle is injected into the skin, the flat surface portion having a large surface area comes into contact with the inside of the skin, and the chemical solution supplied to the flow path is discharged to the flat surface portion side. Can be injected.
According to a second aspect of the present invention, the microneedle is composed of a groove having a flow path opened in a flat portion, an internal flow path opened in a rear end side of the needle body, and a communication hole. It is drilled by processing. Therefore, the microneedle according to claim 2 can be easily obtained by forming the external shape of the microneedle, the groove, and the internal flow path by injection molding, and then drilling the communication hole from the groove side by a laser processing machine. Can be manufactured. Further, since the microneedle according to claim 2 is not configured to form a flow path by attaching a lid to the groove, there is a problem that the lid peels off even if the microneedle is pierced into the skin or the like. There is nothing.
Further, in the microneedle according to claim 3, the needle body is composed of two divided elements, and the flow path groove is closed by combining the other divided element and the one divided element. Since the said flow path is formed, it can be manufactured by a simpler method.
Further, the microneedle according to claim 4 can be easily manufactured in the same manner as the microneedle according to claim 4, and the flow path is formed by engaging the engaging convex portion in the flow path groove. It is possible to prevent the chemical liquid from leaking from the flow path to the dividing surface.
Moreover, the microneedle of Claim 5 is a microneedle in any one of Claims 1-5, The convex part is provided in the front end side of the plane part. Therefore, when the microneedle is pierced into the skin, the skin tissue is lifted from the flat portion by the convex portion, and the opening of the flow path provided in the flat portion is prevented from being blocked by the skin tissue. Can do.
Moreover, since the microneedle of Claim 6 has the micro groove | channel connected to the opening part of the said flow path in the said plane part, a chemical | medical solution can be injected efficiently.
Moreover, since the microneedle array of Claim 7 is provided with the microneedle of any one of Claims 1-6, the microneedle of any one of Claims 1-6 The same effect can be produced, and when a plurality of microneedles are provided, injection can be performed at a time at a plurality of skin-like locations.
Further, the microneedle array according to claim 8 is provided with the microneedle according to claim 4, and the other divided element projects and is formed integrally with the case from the outer edge of the through hole. Is provided in the microneedle unit that is installed in the case through the through-hole, so that the other split element is less likely to fall off and the reliability is high.
Moreover, since the microneedle array apparatus of Claim 9 guides a microneedle array using a guide jig, it can perform injection by a microneedle array easily.
In the microneedle array device according to claim 10, the guide portion is provided with an inclined guide portion that guides the microneedle array in an oblique direction and a horizontal guide portion that guides the microneedle array horizontally. Therefore, the microneedle array can be moved according to the inclination angle of the microneedle and stabbed into the skin or the like, and then the microneedle array can be moved horizontally. Thereby, since a space can be formed in the skin where the microneedle is pierced and a chemical solution can be injected into the space, more efficient injection becomes possible.
Further, in the microneedle array device according to the eleventh aspect, since the inclined guide portion guides the microneedle array along the central axis of the microneedle, the microneedle is inserted when the microneedle pierces the skin. No force is applied in such a direction that the needle is bent, so that the tip and tip of the microneedle can be prevented from being deformed and damaged, and injection can be performed safely.
Moreover, since the microneedle array apparatus of Claim 12 is provided with the slider engaged with the said microneedle array, injection by a microneedle array can be easily performed by using this slider.

1A and 1B are views showing a first embodiment of the present invention, in which FIG. 1A is a plan view showing a microneedle unit according to the present embodiment, and FIG. 1B is a front view showing a microneedle unit according to the embodiment; FIG. 1 and FIG. 1C are cross-sectional views taken along the line cc in FIG. It is a figure which shows 1st Embodiment of this invention, and is sectional drawing which shows the state which inclined and stabbed the microneedle unit by this Embodiment to skin. FIG. 3A is a front view showing a microneedle unit according to this embodiment, and FIG. 3B is a side view showing the microneedle unit according to this embodiment. FIG. It is a figure which shows 2nd Embodiment of this invention, and is an exploded side view of the microneedle unit by this Embodiment. FIG. 5A is a cross-sectional view taken along the line aa in FIG. 4 and FIG. 5B is a cross-sectional view taken along the line bb in FIG. 3B. It is a figure which shows 3rd Embodiment of this invention, and is an enlarged view of the microneedle part of the microneedle unit by this Embodiment. It is a figure which shows 4th Embodiment of this invention, and is a perspective view which shows the microneedle array by this Embodiment. FIG. 8A is a cross-sectional view taken along line VIII-VIII in FIG. 7, and FIG. 8B is an enlarged cross-sectional view of a portion b in FIG. 8A. is there. It is a figure which shows 4th Embodiment of this invention, It is a disassembled perspective view of the microneedle array by this Embodiment. It is a figure which shows 5th Embodiment of this invention, and is a perspective view which shows the microneedle array by this Embodiment. It is a figure which shows 5th Embodiment of this invention, It is a disassembled perspective view of the microneedle array by this Embodiment. FIG. 12A is a cross-sectional view taken along the line XII-XII in FIG. 10, and FIG. 12B is an enlarged cross-sectional view of a portion b in FIG. 12A, showing a fifth embodiment of the present invention. is there. It is a figure which shows 5th Embodiment of this invention, and is the elements on larger scale of the microneedle of the microneedle array by this Embodiment. It is a figure which shows 6th Embodiment of this invention, It is a disassembled perspective view of the microneedle array apparatus by this Embodiment. It is a figure which shows 6th Embodiment of this invention, It is a perspective view of the microneedle array used for the microneedle array apparatus by this Embodiment. It is a figure which shows 6th Embodiment of this invention, It is an enlarged view of the guide hole part for microneedle arrays of the guide for microneedle arrays used for the microneedle array apparatus by this Embodiment. The figure which shows 6th Embodiment of this invention, It is a relationship between the attachment angle of the microneedle in the microneedle array used for the microneedle array apparatus of this Embodiment, and the angle of the inclination part of the guide hole for microneedle arrays FIG. It is a figure which shows 6th Embodiment of this invention, and is XVIII-XVIII sectional drawing in FIG. 14 of the slider used for the microneedle array apparatus by this Embodiment. FIG. 19A is a diagram showing a sixth embodiment of the present invention, FIG. 19A is a side view showing a state in which the microneedle array device according to the present embodiment is ready for injection, and FIG. 19B is a diagram showing the present embodiment. The side view which shows the state which made the microneedle array apparatus by the form the piercing | piercing state, FIG.19 (c) is the side view which shows the state which made the microneedle array apparatus by this Embodiment the expanded state. FIG. 20A is a view showing a conventional microneedle unit, FIG. 20A is a view showing a state in which the microneedle is pierced perpendicularly to the skin, and FIG. 20B is an inclination of θ ° with respect to the skin. It is a figure which shows the state pierced. It is the figure which showed the conventional microneedle unit, Fig.21 (a) is a front view of a microneedle unit, FIG.21 (b) is bb sectional drawing in Fig.20 (a).

The microneedle unit according to the first embodiment of the present invention will be described below with reference to FIGS. 1 and 2.
As shown in FIGS. 1A to 1C, the microneedle unit 1 according to the present embodiment protrudes from a main body 1a and the upper surface of the main body 1a (the upper surface in FIG. 1B). The substantially cylindrical projection 1b is formed, and the microneedle 1c is projected and formed from the end surface of the projection 1b on the side opposite to the main body 1a (upper side in FIG. 1B).
Inside the microneedle unit 1, there is formed an internal channel 1d that opens on the surface of the main body 1a on the side opposite to the microneedle 1c (the lower side in FIG. 1B).

  The microneedle 1c has a pointed shape obtained by equally dividing a substantially quadrangular pyramid shape into two in the vertical direction, and a microneedle-side flow channel 1f is formed on a plane portion 1e that is a divided surface. The microneedle side channel 1f is a groove that opens to the flat portion 1e and becomes shallower toward the tip side of the microneedle 1c (upper side in FIG. 1C). The shape of the opening is shown in FIG. It is a substantially triangular shape as shown in (b). The microneedle side flow path 1f and the internal flow path 1d are connected by a communication hole 1g. Moreover, the opening part by the side of the said plane part 1e of the said microneedle side flow path 1f is the outflow port 1h. Further, the opening on the surface of the internal channel 1d on the side opposite to the microneedle 1c (the lower side in FIG. 1B) is an inflow port 1i.

The microneedle unit 1 according to the present embodiment is manufactured as follows.
First, the microneedle unit 1 in a state where the internal flow path 1d and the microneedle side flow path 1f are formed is formed by an injection molding method.
Next, from the opening on the flat portion 1e side of the microneedle side channel 1f, the surface on the internal channel 1d side of the microneedle side channel 1f by a laser processing machine (not shown) (FIG. 1C). Perforations are made in the middle and lower surface), thereby forming communication holes 1g which are through holes communicating with the internal flow path 1d.
Thus, the microneedle unit 1 including the microneedle side channel 1f and the internal channel 1d communicated with each other via the communication hole 1g is manufactured.

The microneedle unit 1 according to the present embodiment is used, for example, in a form as shown in FIG.
That is, the microneedle 1c is oriented with an arbitrary angle (θ °, for example, 30 °) inclined with respect to the surface of the skin 3 with the flat portion 1e of the microneedle 1c facing the skin 3 side. Is inserted into the skin 3. The microneedle unit 1 is supplied with a chemical solution from the inlet 1i by a chemical solution supply unit (not shown).
The microneedle 1 c is inserted into the skin 3 until the outflow port 1 h completely enters the skin 3. By doing so, it is possible to prevent the chemical liquid from leaking to the surface of the skin 3.

  Further, since the microneedle 1c is pierced into the skin 3 while being inclined with respect to the skin 3, the microneedle 1c has a larger portion to enter the skin 3 than the microneedle 1c. The vertical depth from the surface of the skin 3 at the tip is reduced. Therefore, the prevention of the chemical liquid leakage to the surface of the skin 3 described above and the reduction of pain given to the patient at the time of injection are made compatible.

As described above, according to the microneedle unit 1 according to the present embodiment, the following effects can be obtained.
The microneedle 1c of the microneedle unit 1 has a shape in which a quadrangular pyramid is equally divided into two in the vertical direction, and a microneedle side channel 1f communicating with the internal channel 1d is opened in the flat portion 1e. The opening is an outlet 1h. Therefore, the flat part 1e and the skin 3 are in great contact with each other, the contact area between the drug solution and the tissue in the skin 3 is increased, and the drug solution can be injected efficiently and reliably.
Further, when the microneedle 1c is pierced into the skin 3, the planar portion 1e is set to face the skin 3 side. Therefore, as shown in FIG. 2, the microneedle 1c enters the skin 3 more on the side where the outlet 1h is opened (upper side in FIG. 2) than on the side where the outlet 1h is not provided. As a result, leakage of the chemical solution can be prevented.

  Further, as described above, the microneedles 1c of the microneedle unit 1 are pierced while being inclined with respect to the skin 3. Therefore, the vertical depth of the tip of the microneedle 1c from the surface of the skin 3 is small for the size of the microneedle 1c entering the skin 3, thereby giving it to the patient at the time of injection. Pain can be reduced. That is, it is possible to achieve both prevention of liquid chemical leakage to the surface of the skin 3 and reduction of pain given to the patient at the time of injection.

The microneedle unit 1 is formed by injection molding other than the communication hole 1g, and then drilled by a laser processing machine from the opening on the flat portion 1e side of the microneedle channel 1f. Manufactured by forming 1 g. Therefore, the microneedle unit 1 having an opening in the microneedle 1c can be easily manufactured.
Further, since the microneedle unit 1 does not have a structure in which a cover or the like, which is a separate member, is attached, the microneedle unit 1 is easy to pierce the skin 3 and has high reliability.

  Next, a microneedle unit 4 according to a second embodiment of the present invention will be described with reference to FIGS.

  As shown in FIG. 3, the microneedle unit 4 according to the present embodiment includes a main body 4 a and a substantially cylindrical convex portion protruding and formed from the upper surface of the main body 4 a (the upper surface in FIG. 3A). 4b, and a microneedle 4c protruding and formed from the end surface of the convex portion 4b on the side opposite to the main body 4a (upper side in FIG. 3B). The microneedle 4c has a pointed shape with a sharp upper side in FIG.

As shown in FIGS. 4 and 5, the microneedle unit 4 is divided into two parts along the longitudinal direction, and is composed of a divided element A and a divided element B. The split element A includes a split main body 4a ₁ , split convex portions 4b ₁ projecting and forming from the upper end surface of the split main body 4a ₁ in FIG. 4, and split micros projecting and formed from the split convex portions 4b _1. and a needle 4c ₁ Metropolitan. Similarly, the dividing element B is divided body 4a _2, the divided body 4a ₂ of FIG. 4 in division protrusions 4b 2 which projects, formed from the end surface of the _upper, is projected-formed from the division protrusions 4b ₂ and a split microneedles 4c ₂ Prefecture.

Further, an engaging convex portion 4g protrudes and is formed on the surface (dividing mating surface) of the dividing element A on the dividing element B side (right side in FIG. 4). Further, the divided microneedles 4c _2, as shown in FIGS. 3 to 5, has become larger than the divided microneedles 4c _1. Further, the tip side of the split microneedles 4c ₂ are formed leading protrusion 4j. Further, the dividing element B is formed with a channel groove 4k that is open on the surface (dividing mating surface) on the dividing element A side (left side in FIG. 4) and on the rear end side (lower side in FIG. 4). Yes.

As shown in FIGS. 3 and 5B, the dividing element A and the dividing element B are integrated by press-fitting / engaging the engaging convex part 4g into the flow channel groove 4k. The microneedle unit 4 is obtained. Furthermore, the above division microneedle 4c ₁ and the divided micro needles 4c ₂ is the microneedles 4c by the combination. Further, the divided body 4a ₁ and the divided body 4a ₂ are combined to form the body 4a. The division is not covered by the microneedles 4c ₁ part of the divided microneedles 4c ₂ of the split microneedles 4c ₁ side of the plane (split mating surface) becomes flat portion 4d. Further, as shown in FIG. 5B, when the engagement convex portion 4g is press-fitted and engaged in the flow channel groove 4k, the opening on the dividing element A side of the flow channel groove 4k is The channel 4m is formed by being closed by the engaging convex portion 4g.

  The flow path 4m opens to the flat portion 4d side, and also opens to the rear end side (lower side in FIG. 3) of the microneedle unit 4. An opening on the flat surface portion 4d side of the flow path 4m is an outflow port 4n, and an opening on the rear end side (lower side in FIG. 3) of the microneedle unit 4 is an inflow port 4i. The flow path 4m is formed in a substantially step shape, and is formed toward the right side in FIG. 3B as it goes downward in FIG. 3B.

  The microneedle unit 4 according to the present embodiment is also manufactured by molding the divided elements A and B by an injection molding method or the like and combining the formed divided elements A and B.

The microneedle unit 4 according to the present embodiment is also used in the same manner as the microneedle unit 1 of the first embodiment described above.
The microneedle unit 4 also has the following actions in addition to the same action as the microneedle unit 1 of the first embodiment described above.
That is, the divided microneedle 4c ₂ is provided with the tip convex portion 4j as described above, and on the rear side (lower side in FIG. 3B) is the outlet 4n of the flow path 4m. Is provided. Therefore, in a state where the microneedle 4c is inserted into the skin, the tip convex portion 4j functions to provide a gap between the outlet 4n and the tissue, whereby the outlet 4n becomes a tissue. Can be prevented from being blocked.
Further, the engagement convex portion 4g is extended and formed in the longitudinal direction of the microneedle unit 4, and the flow channel groove 4k is also extended and formed in the longitudinal direction of the microneedle unit 4. The engagement protrusion 4g functions to reinforce the microneedle 4c against an external force from a direction orthogonal to the axial direction of the microneedle 4c in the engagement groove 4k.

The microneedle unit 4 according to the present embodiment has the following effects in addition to the effects similar to the effects of the microneedles 1 according to the first embodiment described above.
Since the microneedle unit 4 is configured by combining the dividing element A and the dividing element B by press-fitting / engaging the engaging convex part 4g in the channel groove 4k, the dividing element A is assembled at the time of assembly. It is easy to position the dividing element B.
Further, since the flow path 4m is configured by press-fitting / engaging the engaging convex portion 4g in the flow path groove 4k, the chemical liquid leaks from the flow path 4m to the dividing element A side. Can be prevented.
Further, since the engagement convex portion 4g reinforces the microneedle 4c against an external force from a direction orthogonal to the axial direction of the microneedle 4c in the flow channel groove 4k, the microneedle 4c is disconnected. Even when it is easy to pierce the skin having a small area and sharp shape, the strength can be ensured and the microneedle 4c can be hardly broken.

Also, the division microneedles 4c ₂ is provided with a leading protrusion 4j, outlet 4n of the flow path 4m are provided in this rear (lower in Fig. 3 side). Therefore, when the microneedle 4c is stabbed into the skin, the tip convex portion 4j functions to provide a gap between the outflow port 4n and the tissue, and the outflow port 4n is blocked by the tissue. Therefore, the drug solution can be efficiently injected.

  The microneedle unit 4 is configured by engaging the dividing element A and the dividing element B, and the engaging projection 4g of the dividing element A is engaged with the flow channel groove 4k of the dividing element B. As a result, the flow path 4m is configured. Therefore, the microneedle unit 4 having the flow path 4m inside can be manufactured by molding the split elements A and B by an injection molding method or the like and combining them. Further, unlike the microneedle 1 according to the first embodiment, the microneedle unit 4 does not need to drill a communication hole using a laser processing machine. Thus, according to this embodiment, the desired microneedle unit 4 can be easily manufactured.

Next, a microneedle unit 5 according to a third embodiment of the present invention will be described with reference to FIG.
Since the microneedle unit 5 according to the present embodiment has the same configuration as the microneedle unit 1 according to the first embodiment described above, the common configuration is the same as that of the first embodiment described above. Reference numerals are given and description thereof is omitted.

  In the case of the present embodiment, a micro groove 5a is formed in the flat portion 1e of the microneedle 1c. As shown in FIG. 6, the micro grooves 5a are formed radially from the outlet 1h toward the outside. The minute groove 5a is communicated with the microneedle side channel 1f.

The microneedle unit 5 is manufactured by, for example, forming the microneedle unit similar to the microneedle unit 1 according to the first embodiment as described above by injection molding and a laser processing machine, and then forming the microgroove 5a by laser. It is manufactured by forming by post-processing using a processing machine.
In addition, after forming the microneedle unit similar to the microneedle unit 1 according to the first embodiment, the microgroove 5a may be formed in the microneedle unit by imprinting.
It is also conceivable to form the minute groove 5a at the time of injection molding by providing a minute projection corresponding to the minute groove 5a on the mold used for the injection molding described above.

The microneedle unit 5 is also used in the same form as the microneedle unit 1 according to the first embodiment as described above.
In the case of this embodiment, since the microgroove 1a is provided with the microgroove 5a, the chemical solution not only flows out of the microneedle 1c from the outlet 1h but also flows into the microgroove 15a. It becomes.

In addition to the effects of the microneedle unit 1 according to the first embodiment described above, the microneedle unit 5 according to the present embodiment also has the following effects.
That is, since the micro-groove 5a is provided in the flat portion 1e of the microneedle 1c, the chemical solution flows into the micro-groove 5a and flows out to a wider range. Therefore, the microneedle unit 5 can inject a drug solution into the skin more efficiently.

Next, with reference to FIG. 2 and FIG. 7 thru | or FIG. 9, the microneedle array 7 by the 4th Embodiment of this invention is demonstrated.
As shown in FIG. 7, the microneedle array 7 according to the present embodiment first includes a case 9. As shown in FIGS. 7 and 9, the case 9 is composed of an upper case 9a and a lower case 9b.

Microneedle unit attachment portions 11 and 11 are formed on the upper case 9a. The microneedle unit mounting portion 11 includes a microneedle unit mounting recess 11a provided on the back surface (lower surface in FIG. 8) of the upper case 9a, and a surface (upper surface in FIG. 8) of the upper case 9a. ) And the concave portion 11b for storing the microneedle. The left surface 11c of the concave portion 11a for attaching the microneedle unit in FIG. 8 is inclined by 30 ° with respect to the horizontal surface of the upper case 9a. Further, the right surface 11d of the microneedle unit mounting recess 9a in FIG. 8 is orthogonal to the surface 11c.
Through holes 11e, 11e, and 11e are provided in the surface 11d.
As shown in FIG. 9, upper case fixing convex portions 12, 12, 12, 12 are projected and formed at the four corners of the surface of the upper case 9 a on the lower case 9 b side.

  In addition, the lower case 9b has a hollow portion 13 that opens upward in FIG. 9, and a chemical solution injection port 15 is formed on the bottom surface (lower surface in FIG. 9) of the hollow portion 13. Further, upper case fixing recesses 17, 17, 17, 17 are formed at the four corners of the surface of the lower case 9b on the upper case 9a side. The upper case 9a and the lower case 9b are combined by engaging the upper case fixing convex portions 12, 12, 12, and 12 with the upper case fixing concave portions 17, 17, 17, and 17, respectively. Case 9 is obtained.

  As shown in FIG. 9, microneedle units 19 and 19 are installed in the microneedle array 7. The microneedle unit 19 includes a substantially rectangular parallelepiped main body 19a, substantially cylindrical convex portions 19b, 19b, and 19b that are projected and formed from the upper right surface of the main body 19a in FIG. 9, and the convex portions 19b, The microneedles 19c, 19c, and 19c are formed so as to protrude from the front end side surfaces (the upper right side surface in FIG. 9) of 19b and 19b. Inside the microneedle unit 19, internal channels 19d, 19d, and 19d are formed that open to the surface of the main body 19a on the side opposite to the microneedle 19c (lower left side in FIG. 8).

Each of the microneedles 19c, 19c, 19c of the microneedle unit 19 has the same configuration as the microneedle 1 in the first embodiment described above. In other words, the microneedle 19c has a pointed shape obtained by equally dividing a substantially quadrangular pyramid shape into two, and a microneedle side channel 19f is formed in a plane portion 19e that is a divided surface. Further, each of the microneedle side flow paths 19f and the corresponding internal flow path 19d are in a one-to-one communication with each other through a communication hole 19g.
Therefore, as shown in FIG. 9, the microneedle unit 19 has a shape in which the three microneedles 1 according to the first embodiment are continuously arranged. Moreover, the opening part by the side of the said plane part 19e of the said microneedle side flow path 19f is the outflow port 19h. Further, an opening on the surface of the internal channel 19d on the side opposite to the microneedle 19c (lower left side in FIG. 8) is an inflow port 19i. Further, the microneedle 19c may be provided with a groove in the flat surface portion 19e like the microgroove 5a of the microneedle of the microneedle unit 5 in the third embodiment described above. Further, the microneedle 19c may be provided with a convex portion on the tip side of the flat surface portion 19e like the tip convex portion 4j of the microneedle unit 4 in the second embodiment described above.

  The microneedle unit 19 has through-holes 11e of the microneedle unit mounting portion 11 provided on the upper case 9a with the convex portions 19b, 19b, 19b from the back side (lower side in FIG. 8) of the upper case 9a. , 11e, and 11e by press fitting. The microneedles 19c, 19c, 19c of the microneedle unit 19 are installed in the microneedle storage recess 11b of the upper case 9a, and the tip side slightly protrudes upward in FIG. 8 of the upper case 9a. I am letting. The main body 19 a of the microneedle unit 19 is installed in the hollow portion 13 of the case 9 while being engaged with the microneedle unit mounting recess 11 a of the microneedle unit mounting portion 11. Further, the microneedle 19c is provided in a state in which the opening on the flat surface portion 19e side of the microneedle side channel 19f faces the opposite case 9 side (upper side in FIG. 7).

  From the above configuration, the microneedle 19c protrudes in a state inclined by 30 ° with respect to the case 9. In addition, two microneedle units 19 are installed per one microneedle array 7, and a total of six microneedles 19c are provided. In addition, a pump 23 is connected to the chemical solution inlet 15 through a chemical solution injection pipe 21. As a result, the chemical solution is supplied to the microneedle array 7.

The microneedle array 7 according to the present embodiment is used in the following form.
First, the surface of the case 9 from which the microneedles 19c protrude (upper surface in FIG. 7) is directed to the skin side so as to be substantially parallel to the skin surface. At this time, the outlet 19h is directed to the skin side.
Thereafter, the six microneedles 19c are pressed against the skin, the microneedle array 7 is advanced in the protruding direction of the microneedles 19c, and the six microneedles 19c are pierced into the skin. The microneedle 19c is pierced into the skin as shown in FIG. At this time, θ ° in FIG. 2 is 30 °.
Thereafter, the pump 23 is operated to supply the chemical solution from the chemical solution inlet 15 into the microneedle array. This chemical solution flows into the internal flow path 19d from the inlet 19i of the microneedle unit 19, reaches the microneedle side flow path 19f through the communication hole 19g, and enters the skin from the outlet 19h of the microneedle 19c pierced into the skin. Injected into.

The microneedle array 7 according to the present embodiment has the following effects in addition to the effects of the microneedle unit 1 according to the first embodiment and the microneedle unit 5 according to the third embodiment described above. Play.
First, since the microneedle array 7 is provided with a large number (six in the case of this embodiment) of microneedles 19c, the microneedle array 7 is provided at a plurality of locations on the skin (six locations in the case of this embodiment). A chemical solution can be injected.
Further, since the microneedle 19c is provided in a state of being inclined with respect to the case 9 (in the case of the present embodiment, being inclined by 30 °), the microneedle 19c is easily attached to the skin surface. Can be stabbed in an inclined state.

Next, a microneedle array according to a fifth embodiment of the present invention will be described with reference to FIGS. 7 and 10 to 13.
The microneedle array 25 according to the present embodiment first includes a case 27 as shown in FIG. As shown in FIGS. 7 and 11, the case 27 is composed of an upper case 27a and a lower case 27b.

  Microneedle unit mounting portions 29, 29 are formed on the upper case 27a. The microneedle unit mounting portion 29 includes a microneedle unit mounting recess 29a provided on the back surface (lower surface in FIG. 12) of the upper case 27a and the surface (upper surface in FIG. 12) of the upper case 27a. ) Provided in the microneedle storage recess 29b. The left surface 29c of the microneedle unit mounting recess 29a in FIG. 12 is inclined by 30 ° with respect to the horizontal surface of the upper case 27a. Further, the right side surface 29d of the concave portion 29a for attaching the microneedle unit in FIG. 12 is orthogonal to the surface 29c.

  The surface 29d is provided with semicircular through holes 29e, 29e, 29e having a substantially semicircular shape. Semi-cylindrical convex portions 29f, 29f, and 29f are provided in the vicinity of the opening on the anti-microneedle unit mounting concave portion 29a side (the upper left side in FIG. 12) of the semicircular through hole 29e. The semi-cylindrical convex portion 29f has a shape in which a cylinder having the same diameter as the through hole 29e is equally divided into two, and a divided mating surface 29g which is a divided surface is a plane of the inner peripheral surface of the through hole 29e. (Continuous to the upper left surface in FIG. 12).

Further, a sub-needle 29h protrudes and is formed from the tip side of each of the semicylindrical convex portions 29f. The sub-needle 29h has a shape obtained by equally dividing the quadrangular pyramid shape into two parts, and a division mating surface 29i which is a division surface thereof is continuous with the division mating surface 29g of the semi-cylindrical convex portion 29f. As shown in FIG. 11, upper case fixing convex portions 30, 30, 30, 30 are projected and formed at the four corners of the surface of the upper case 27 a on the lower case 27 b side.
The upper case 27a is formed by injection molding.

  Further, the lower case 27b has a hollow portion 31 that opens upward in FIG. 11, and a chemical liquid injection port 33 is formed on the bottom surface (lower surface in FIG. 11) of the hollow portion 31. Further, upper case fixing recesses 35, 35, 35, 35 are formed at the four corners of the surface of the lower case 27b on the upper case 27a side. The upper case 27a and the lower case 27b are combined by engaging the upper case fixing convex portions 30, 30, 30, 30 with the upper case fixing concave portions 35, 35, 35, 35. Case 9 is obtained.

  As shown in FIGS. 11 and 12, microneedle units 37 and 37 are installed in the microneedle array 25. First, the microneedle unit 37 is provided with a substantially rectangular parallelepiped main body 37a. Semi-cylindrical convex portions 37b, 37b, and 37b are projected and formed from the upper right side surface of the main body 37a in FIG. The semi-cylindrical convex portion 37b has a shape such that a cylinder having a diameter substantially the same as the diameter of the through hole 29e is equally divided into two, and the division surface is a division mating surface 37c.

Further, a main needle 37d is formed so as to project from the tip side surface (the upper right surface in FIG. 12) of each of the semi-cylindrical convex portions 37b, 37b, 37b. The main needle 37d has a pointed shape that is obtained by equally dividing the quadrangular pyramid shape into two parts, and the division mating surface 37e that is the division surface is continuous with the division mating surface 37c of the semi-cylindrical convex portion 37b. ing. Further, inside the main body 37a, internal flow paths 37f, 37f, 37f are formed that open on the surface of the main body 37a on the side opposite to the main needle 37d (lower left side in FIG. 12). In addition, microneedle-side channel grooves 37g are formed on the division mating surfaces 37e of the individual main needles 37d and the division mating surfaces 37c of the semi-cylindrical convex portions 37b. The microneedle side channel groove 37g communicates with the internal channel 37f. Further, the opening on the surface of the internal flow path 37f on the side opposite to the main needle 37d (lower left side in FIG. 12) is an inflow port 37h.
The microneedle unit 37 is molded by injection molding.

  The microneedle unit 37 has semi-cylindrical convex portions 37b, 37b, 37b from the back side of the upper case 27a (lower side in FIG. 12) of the microneedle unit mounting portion 29 provided on the upper case 27a. It is attached by press-fitting into the semicircular through holes 29e, 29e, 29e. At this time, as shown in FIG. 12, the main needles 37d, 37d, 37d of the microneedle unit 37 are projected and formed in the microneedle storage recess 29b of the upper case 9a. In combination with 29h, microneedles 39, 39, 39 are formed.

As shown in FIG. 13, the microneedle 39 is in contact with the main needle 37d and the sub-needle 29h in a state where the divisional mating surface 37e and the divisional mating surface 29i face each other. Further, the positions of the base end portions (lower end in FIG. 13) of the main needle 37d and the sub-needle 29h are aligned, and the base of the microneedle side flow channel groove 37g formed on the split alignment surface 37e of the main needle 37d. The end side (lower side in FIG. 13) is closed by the auxiliary needle 29h. Therefore, the outflow port 39a is formed in the front end side of the said microneedle side flow-path groove | channel 37g.
Further, the microneedle-side channel groove 37g is divided into a split mating surface 29i of the sub-needle 29h, a split mating surface 29g of the semi-cylindrical convex portion 29f, and a plane portion of the inner peripheral surface of the through hole 29e (upper left in FIG. 12). The flow path 39b is configured by being blocked by the side surface. The opening of the flow path 39b on the tip side of the microneedle 39 is the outlet 39a. Further, a portion of the divisional mating surface 37e that is exposed without being covered by the divisional mating surface 29i is a flat surface portion 39c.

  Further, the microneedle 39 is housed in the microneedle housing recess 29b of the upper case 27a, and its tip side is slightly protruded upward in FIG. 12 of the upper case 27a. The main body 37 a of the microneedle unit 37 is installed in the hollow portion 31 of the case 27 in a state of being engaged with the microneedle unit mounting recess 29 a of the microneedle unit mounting portion 29.

  The microneedle array 25 according to the present embodiment is used in the same form as the microneedle array 7 according to the fourth embodiment described above.

The microneedle array 25 according to the present embodiment has the following effects in addition to the effects of the microneedle array 7 according to the fourth embodiment described above.
The microneedle 39 of the microneedle array 25 is configured by combining a main needle 37d provided in the microneedle unit 27 and a sub needle 29h provided in the upper case 27a. The upper case 27a is formed by injection molding. Therefore, the microneedle 39 provided with the outflow port 39a communicating with the internal flow path 37f is further used without using a laser processing machine as in the case of manufacturing the microneedle unit 1 of the first embodiment described above. It can be manufactured easily.

Next, a microneedle array device according to a sixth embodiment will be described with reference to FIGS.
The microneedle array device 41 according to the present embodiment first includes a microneedle array guide 43. The microneedle array guide 43 is composed of a bottom plate 45 and guide plates 47, 47 erected vertically from both ends thereof.

  The guide plate 47 is formed with microneedle array guide holes 49, 49, 49, 49. As shown in FIGS. 14, 16 and 17, the microneedle array guide holes 49 are open to the bottom plate 45 side (upper side in FIG. 14) perpendicular to the bottom plate 45. The vertical portion 49a, the inclined portion 49b inclined by a predetermined angle (θc ° in the present embodiment) with respect to the bottom plate 45 and lower on the front side (right side in FIG. 14), and the bottom plate 45 It consists of a horizontal part 49c parallel to it.

  In addition, a slider insertion guide groove 51 that is a groove perpendicular to the bottom plate 45 is formed outside the microneedle array guide 43 in the center of the guide plate 47 in the horizontal direction (left and right direction in FIG. 14). ing. A slider moving guide groove 53 that is a horizontal groove with respect to the bottom plate 45 is formed outside the microneedle array guide 43 on the lower end side (lower side in FIG. 14) of the guide plate 47. . As shown in FIG. 14, the bottom plate 45 has two rows in which three through holes 55 are arranged.

  As shown in FIG. 14, the microneedle array device 41 includes a microneedle array 57. As shown in FIG. 15, the microneedle array 57 can be substantially the same as the microneedle array according to the fourth embodiment and the fifth embodiment described above. In the case of the embodiment, a microneedle array that is substantially the same as the microneedle array 7 according to the fourth embodiment is used, the same reference numerals are given to the common configurations, and description thereof is omitted.

  As shown in FIG. 15, microneedle array side guided portions 57 a, 57 a, 57 a, 57 a are projected and formed on the side surface of the case 9 of the microneedle array 57. The microneedle array side guided portion 57a has a substantially cylindrical shape, and the diameter thereof is substantially the same as the width of the microneedle array guide hole 49. Therefore, the microneedle array side guided portion 57a can be slidably disposed in the microneedle array guide groove 49.

Further, the microneedle units 19 and 19 of the microneedle array 57 are the surfaces on which the microneedles 19c, 19c, 19c of the individual microneedle unit 19 project from the microneedles 19c of the case 9 (the lower side in FIG. 17). It is installed in a state inclined by θs ° with respect to the surface.
When the angle in the plane of FIG. 17 between the plane portion 19e of the microneedle 19c (lower surface in FIG. 17) and the back side of the microneedle 19c (upper side in FIG. 17) is θn °, In the present embodiment, the relationship θs ° = θc ° −θn ° / 2 is established. Note that θn ° / 2 is an angle between the central axis of the microneedle 19c and the flat portion 19e.
At this time, the direction in which the microneedle array 19 is guided by the inclined portion 49b of the microneedle array guide hole 49 coincides with the direction of the central axis of the microneedle 19c.

  In the present embodiment, the microneedle unit 19, the microneedles 19c, and the microneedle array guide holes 49 are inclined so that the relationship θs ° = θc ° −θn ° / 2 is established. The inclination angle of the portion 49b and the shape of the microneedle 19c are set. When such a relationship is established, the microneedle array 19 can be moved along the central axis of the microneedle 19c by the inclined portion 49b of the microneedle array guide hole 49. .

Hereinafter, the fact that the relationship of θs ° = θc ° −θn ° / 2 is established will be described with reference to FIG.
First, as shown in FIG. 17, the guide direction of the center axis of the microneedle 19c and the inclined portion 49 of the guide hole 49 for the microneedle array is a straight line 11, and the plane portion 19e of the microneedle 19c and the paper surface of FIG. The line of intersection with the straight line l2, the line of intersection of the lower surface of the microneedle array 19 in FIG. 17 and the paper surface of FIG. 17 as the line m, and a straight line parallel to the bottom plate 45 of the microneedle array guide 43 Is a straight line n.

  Since the straight line m and the straight line n are parallel, the angle between the straight line 11 and the straight line n and the angle between the straight line 11 and the straight line m are equal to θc °. The angle between the straight line l1 and the straight line l2 is θn ° / 2 since the straight line l1 is the central axis of the microneedle 19c. Further, the angle between the straight line m and the straight line l2 is θs °. Therefore, from FIG. 17, θc ° is the sum of θs ° and θn ° / 2, and the relationship of θc ° = θs ° + θn ° / 2 is established. Then, the equation θs ° = θc ° −θn ° / 2 can be derived from the equation θc ° = θs ° + θn ° / 2.

  Further, as shown in FIG. 14, the microneedle array device 41 is provided with a slider 59. The slider 59 is composed of a top plate 61 and side plates 63, 63 erected vertically from both ends of the top plate 61. An anti-slip 65 is formed on the opposite side plate 63 side of the top plate 61. The anti-slip 65 is composed of a plurality of (six in the case of the present embodiment) projections 67 formed in a direction orthogonal to the side plate 63 and having a substantially equilateral triangular cross-sectional shape.

The side plate 63 is formed with slits 69 and 69 perpendicular to the top plate 61. The width of the slit 69 is substantially the same as the diameter of the microneedle array side guided portion 57 a, and the microneedle array side guided portion 57 a can be slidably disposed in the slit 69.
Further, as shown in FIGS. 14 and 18, slider-side guided portions 71 and 71 are projected and formed on the surface of the side plate 63 facing the other side plate 63. The slider-side guided portion 71 has a substantially quadrangular prism shape, and its lateral width (length in the left-right direction in FIG. 18) is substantially the same as the width of the slider insertion guide groove 51 of the microneedle array guide 43. The vertical width (vertical length in FIG. 18) is substantially the same as the width of the slider movement guide groove 53 of the microneedle array guide 43. Therefore, the slider-side guided portion 71 can be slidably disposed in the slider insertion guide groove 51 and the slider movement guide groove 53.

The microneedle array device 41 according to the present embodiment is used as follows.
First, the microneedle array guide 43 is fixed to the surface of the skin 73. At that time, the surface of the microneedle array guide 43 on the side opposite to the guide plate 47 (the lower side in FIG. 14) and the surface of the skin 73 are bonded with an adhesive or double-sided tape (not shown).

Next, the microneedle array 57 is attached to the microneedle array guide 43. At this time, the microneedle array side guided portions 57a, 57a, 57a, 57a are inserted into the corresponding microneedle array guide holes 49, 49, 49, 49, respectively.
Further, the microneedle array 57 is installed at a position where the microneedle array-side guided portion 57a contacts the bottom surface (the lower surface in FIG. 16) of the vertical portion 49a of the microneedle array guide hole 49. .

Next, a slider 59 is attached to the microneedle array 57 and the microneedle array guide 43. At this time, two of the slider-side guided portions 71, 71, 71, 71 on the front (right side in FIG. 14) are inserted into the slider insertion guide grooves 51, 51 of the microneedle array guide 43. . The slider 59 is guided by the interaction between the two slider-side guided portions 71 and 71 and the slider insertion guides 51 and 51, and the two slider-side guided portions 71 and 71 are guided by the slider insertion guide groove 51. , 51 is moved downward in FIG. 14 until it contacts the slider movement guide grooves 53, 53 orthogonal to 51. The microneedle array side guided portions 57a, 57a, 57a, 57a are inserted into the slits 69, 69, 69, 69 of the slider 59.
At this time, the microneedle array device 41 is in a state as shown in FIG. This is the injection preparation state of the microneedle array device 41.

Next, the slider 59 is urged by a hand or the like, and moved forward (right side in FIG. 19A). Then, the microneedle array 57 is guided by the inclined portion 49 b of the microneedle array guide hole 49 while the microneedle array side guided portion 57 a is pressed by the inner peripheral surface of the slit 69 of the slider 59. Thus, it is moved in the diagonally downward direction (the lower right direction in FIG. 19A).
At this time, the slider 59 is guided by the interaction between the slider movement guide groove 53 and the slider-side guided portion 71 and moves horizontally (to the right in FIG. 19A).

When the microneedle array-side guided portion 57a reaches the lower end of the inclined portion 49b of the microneedle array guide hole 49 (the lower right end in FIG. 19A), the microneedles 19c of the microneedle array 57, 19c, 19c, 19c, 19c, and 19c penetrate through the through holes 55, 55, 55, 55, 55, and 55 and pierce the surface of the skin 73 at a predetermined angle (θs °). At this time, in the microneedle 19c, all the openings of the microneedle side channel 19f enter the skin 73, and the chemical solution flowing out from the openings of the microneedle side channel 19f leaks to the surface of the skin 73. It is pierced to a depth that does not come out.
At this time, the microneedle array device 41 is in a state as shown in FIG. This is the perforated state of the microneedle array device 41.

Next, the slider 59 is urged by a hand or the like, and moved forward (right side in FIG. 19B). Then, the microneedle array 57 is guided by the horizontal portion 49 c of the microneedle array guide hole 49 while the microneedle array side guided portion 57 a is pressed by the inner peripheral surface of the slit 69 of the slider 59. Then, it is moved forward (to the right in FIG. 19B).
Also at this time, the slider 59 is guided by the interaction between the slider movement guide groove 53 and the slider-side guided portion 71 and moves horizontally (to the right in FIG. 19B).

  Along with the movement of the microneedle array 57, the microneedle 19c stabbed into the skin 73 is also moved forward (rightward in FIG. 19B), and forward of the microneedle 19c (in FIG. 19B). Press the skin 73 on the right side). As a result, the skin 73 is deformed as shown in FIG. 19C, and a space 75 is created behind the microneedle 19c (left side in FIG. 19C). The outlet 19h of the microneedle 19c is opened to the space 75 side. The state shown in FIG. 19C is the expanded state of the microneedle array device 41.

  Thereafter, a chemical solution is supplied to the microneedle array 57 from a pump (not shown) connected to the chemical solution inlet 15 of the microneedle array 57. This chemical solution flows out into the space 75 from the outlets 19h, 19h, 19h, 19h, 19h, 19h of the microneedles 19c, 19c, 19c, 19c, 19c, 19c, and thereby the chemical solution enters the skin 73. It will be injected.

The microneedle array device according to the present embodiment has the following effects in addition to the effects of the microneedle array 7 according to the fourth embodiment described above.
First, the attachment angle of the microneedle unit 19 to the case 9 and the inclination angle of the inclined portion 49 b of the microneedle array guide hole 49 formed in the microneedle array guide 43 are the inclination angle of the central axis of the microneedle 19. And the inclination angle of the inclined portion 49b are set to coincide with each other. Therefore, by guiding the microneedle array 57 using the microneedle array guide 43, the microneedle array 57 can be moved along the central axis of the microneedle 19c, and the microneedle 19c, 19c, 19c, 19c, 19c, 19c can be pierced with respect to the skin 73 accurately along the inclination angle of the central axis.

  The microneedle 19c moves along the central axis and pierces the skin 73. Therefore, when the microneedle 19c pierces the skin 73, the force that the microneedle 19c receives from the skin 73 acts equally on the central axis of the microneedle 19c, Damage can be prevented.

In addition, since the microneedle 19c is pierced into the skin 73 and then moved forward, a space 75 is created, and the outlet 75h of the microneedle 19c is opened in the space 75. A chemical solution can often be injected into the skin 73.
The microneedle array guide hole 49 is provided with a vertical portion 49a, and the bottom surface (the lower surface in FIG. 16) is horizontal. Therefore, if the microneedle unit 57 is installed so that the microneedle array side guided portions 57a, 57a, 57a, 57a of the microneedle unit 57 are in contact with the bottom surface, the microneedle unit 57 is used for the microneedle array. It is possible to prevent the microneedle 19c from inadvertently piercing the skin 73 immediately after being installed on the guide 43.

  The microneedle unit 57 has substantially the same configuration as the microneedle array 7 according to the fourth embodiment described above, but instead of the microneedle array 25 according to the fifth embodiment described above, If it uses, the effect by this microneedle array 25 can be show | played.

The present invention is not limited to the above embodiment.
For example, various cases can be considered for the shape, size, and number of microneedles. In the above embodiment, the microneedle has a shape in which a quadrangular pyramid is equally divided into two as its constituent element, but a conical shape or other polygonal shape that is equally divided into two is used as a constituent element. It is also possible.
Moreover, it is good also as a structure which provides the pump etc. for chemical | medical solution supply in a microneedle array.

Moreover, you may provide the front-end | tip convex part provided in the front end side of the plane part of the microneedle by 2nd Embodiment in the front end side of the plane part of the microneedle by 1st Embodiment.
Moreover, you may provide the micro groove | channel provided in the plane part of the microneedle by 3rd Embodiment in the plane part of the microneedle by 2nd Embodiment.
Further, in the microneedle array according to the fourth embodiment and the microneedle array apparatus according to the sixth embodiment, the microneedle unit according to the first embodiment may be used.
Further, in the microneedle array according to the fourth embodiment or the microneedle array device according to the sixth embodiment, the microneedle unit according to the second embodiment or a microneedle unit in which a plurality of the microneedle units are connected may be used. Good.
In the microneedle array device according to the sixth embodiment, it is also conceivable that the microneedle array is directly advanced by hand or the like without using a slider.

  The present invention relates to, for example, a microneedle and a microneedle array device that pierce the skin and inject, and in particular, pierces the microneedle while being inclined with respect to the skin. The present invention relates to a device devised so as to realize prevention of chemical leakage to the skin surface, and is suitable for, for example, a microneedle array device used for transdermal administration of insulin.

1c Microneedle 1d Internal flow path 1e Flat part 1f Microneedle side flow path 1g Connecting hole 1h Outlet 4b Microneedle A Split element B Split element 4g Engaging convex part 4k Channel groove 4d Plane part 4m Channel 5a Micro groove 7 Microneedle array 9 Case 19c Microneedle 19d Internal flow path 19e Flat part 19f Microneedle side flow path 19g Communication hole 19h Outlet 25 Microneedle array 27 Case 29e Semicircular through hole 29h Sub needle 29i Dividing and mating surface 37 Microneedle unit 37d Main needle 37e Dividing and mating surface 37f Internal flow path 37g Microneedle side flow path groove 39c Flat part 39 Microneedle 39a Outlet 41 Microneedle array device 43 Microneedle array guide 45 Bottom plate 47 Ga De plate 49 guiding the microneedle array hole 55 through hole 57 microneedle array 57a microneedle array-side guided portion 59 slider

Claims (12)

A needle having a pointed shape, a flat surface provided on the outer peripheral surface of the needle, a flow provided inside the needle and open to the flat surface and open to the rear end side And a microneedle. The microneedle according to claim 1, wherein
The flow path includes an internal flow path opened on the rear end side of the needle body, a groove opened in the flat portion, and a communication hole drilled by laser processing through the internal flow path and the groove. A microneedle comprising: The microneedle according to claim 1, wherein
The needle body has a split structure composed of two divided elements,
The split mating surface of one split element exposed in the state where the two split elements are combined functions as the plane portion,
The one split element is formed with a flow channel opening on the split mating surface side and also opening on the rear end side of the needle body,
A microneedle characterized in that the flow path groove is formed by combining the other divided element and the one divided element, thereby forming the flow path. The microneedle according to claim 3, wherein
The other split element is provided with an engaging convex portion that engages in a flow channel groove provided in the one split element,
The microneedle, wherein the channel is formed by engaging the engaging convex portion in the channel groove. In the microneedle according to any one of claims 1 to 4,
A microneedle, wherein a convex portion is provided on a tip side of the flat portion. In the microneedle according to any one of claims 1 to 5,
A microneedle characterized in that a minute groove communicating with the opening on the planar portion side of the flow path is formed in the planar portion. A microneedle array, comprising: a case; and the microneedle according to any one of claims 1 to 6, wherein the microneedle is protruded and arranged so as to be inclined with respect to a surface of the case. The microneedle array according to claim 7, wherein
The above case has the same number of through holes as microneedles,
The microneedle is the microneedle according to claim 4,
The other split element projects and is formed integrally with the case from the outer edge of the through hole,
The microneedle array, wherein the one split element is provided in a microneedle unit that is installed in the case through the through hole. The microneedle array according to claim 7 or 8, wherein a guide portion is formed on a side surface;
A guide jig comprising a bottom plate having the same number of through-holes as the microneedles and a pair of guide plates standing from the bottom plate and engaged with the guided portion to form a guide portion for guiding the microneedle array And comprising
The microneedle array device is characterized in that the microneedle array is moved by the guide jig so that the microneedle penetrates the through hole and protrudes to the opposite guide plate side of the bottom plate. The microneedle array device according to claim 9,
The microneedle array device, wherein the guide portion is provided with an inclined guide portion that guides the microneedle array in an oblique direction and a horizontal guide portion that guides the microneedle array horizontally. The microneedle array device according to claim 10, wherein
The microneedle array device, wherein the inclined guide portion guides the microneedle array along a central axis of the microneedle. In the microneedle array device according to any one of claims 9 to 11,
A slider to be engaged with the microneedle array is provided;
The microneedle array device, wherein the microneedle array is moved via the slider.

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