WO2015111672A1 - マイクロニードルユニット - Google Patents
マイクロニードルユニット Download PDFInfo
- Publication number
- WO2015111672A1 WO2015111672A1 PCT/JP2015/051732 JP2015051732W WO2015111672A1 WO 2015111672 A1 WO2015111672 A1 WO 2015111672A1 JP 2015051732 W JP2015051732 W JP 2015051732W WO 2015111672 A1 WO2015111672 A1 WO 2015111672A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- microneedle
- lid
- contact surface
- target
- puncture target
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0046—Solid microneedles
Definitions
- the technology of the present disclosure relates to a microneedle unit including a microneedle and a container that accommodates the microneedle.
- the percutaneous absorption method includes causing a substance to be administered, such as a drug, to penetrate into the body from the skin without causing pain in the administration symmetry of a person or the like.
- a method of administering a drug or the like into the skin by inserting a microneedle into the skin has been proposed.
- the microneedle includes a protrusion having a size that does not cause pain to the administration target, and the protrusion penetrates the stratum corneum, which is a barrier layer of the skin.
- medical agent is percutaneously absorbed because a chemical
- the protrusion of the microneedle is covered with a cover that protects the protrusion in a state before the microneedle is used by a user as described in Patent Document 1, for example.
- the cover is bonded to the base that supports the protrusion by an adhesive.
- the user when using the microneedle, the user removes the cover from the microneedle. Since the cover is directly bonded to the microneedle substrate, the shape of the microneedle substrate changes depending on how the user removes the cover. Thereby, the protrusion part of a microneedle may contact a user's finger
- One aspect of the microneedle unit in the technology of the present disclosure includes a facing surface that faces a puncture target to be stabbed by a microneedle, and a surface to be bonded that is a surface opposite to the facing surface.
- the said microneedle which has the above projection part, It is a concave container which accommodates the said microneedle, Comprising: The said concave container provided with the opening part surrounding the said microneedle, and the said concave container so that the said opening part may be plugged up A lid portion having a plate shape, the lid portion extending from the adherend surface to the periphery of the adherend surface, located between the lid portion and the adherend surface, and the lid portion and the An adhesive portion that adheres to the adherend surface.
- the concave container is configured to release the connection with the lid part in a state where the microneedle is adhered to the lid part by the adhesive part by receiving a force in a direction away from the lid part,
- the bonding portion contacts the first contact surface that contacts the lid portion, the surface to be bonded, and extends from the surface to be bonded to the periphery of the surface to be bonded, and the projection portion pierces the puncture target.
- a second contact surface that contacts a portion of the puncture target that is located around the facing surface.
- the protrusion is stuck into the object by pressing the lid part bonded to the microneedle toward the object to be punctured. This makes it difficult for the user to touch the microneedle when the microneedle is stabbed into the puncture target. As a result, when the user inserts the microneedle into the puncture target, the handling of the microneedle unit becomes easier.
- the bonding portion includes a portion of the second contact surface that is positioned around the surface to be bonded when the protruding portion is inserted into the puncture target. It is preferable that the adhesive portion is configured so that the first contact surface is peeled off from the lid portion when the lid portion is adhered to the puncture target and the lid portion receives a force in a direction away from the target.
- the microneedle is peeled off from the lid portion after the protrusion has pierced the puncture target. Therefore, when the user pierces the puncture target with the microneedle, the microneedle can be easily handled.
- the adhesive force of the second contact surface to the puncture target is greater than the force required to increase the distance between the second contact surface and the lid portion. Is also preferably large.
- the adhesive force of the second contact surface with respect to the puncture target is greater than the force required to increase the distance between the second contact surface and the lid portion. For this reason, the lid portion is easily peeled off from the microneedle.
- the lid portion is in contact with a portion of the puncture target that is located around the adhesive portion when the protrusion pierces the puncture target.
- a contact surface is provided. At least a part of the third contact surface has adhesiveness to the puncture target, and the adhesive force of the third contact surface to the puncture target is around the adherend surface in the second contact surface. It is preferable that the adhesive strength of the portion to be punctured is smaller.
- the microneedle unit in the technology of the present disclosure in the configuration in which at least a part of the third contact surface has adhesiveness to the puncture target, when the microneedle is stabbed into the puncture target, the second contact surface in the adhesion portion In addition to a part of the third contact surface, the third contact surface is also adhered to the puncture target. Therefore, the microneedle is stabbed into the puncture target in a state where the position in the puncture target is positioned by the third contact surface. Therefore, the microneedle is likely to pierce the puncture target when it receives a force in the direction of pressing against the puncture target.
- a material for forming the first contact surface and a material for forming the second contact surface are different from each other.
- the lid portion has a plurality of steps in at least a part of a portion in contact with the first contact surface.
- the adhesive force of the first contact surface to the lid portion is bonded to the lid portion by the easy method of forming a step in the lid portion. It becomes possible to make it smaller than the adhesive force with respect to the object of the part located around the surface.
- the adhesive portion includes a first portion having the first contact surface, a second portion having the second contact surface, the microneedle, and the puncture target. It is preferable to further include a third portion that is positioned between the first portion and the second portion in the direction in which the first portion and the second portion are opposed and has higher rigidity than the second portion.
- the second portion that contacts the microneedle is closer to the first contact surface that is peeled off from the lid.
- the third portion having high rigidity is also located. Therefore, when the lid part is peeled off from the microneedle, the deformation of the second part is suppressed by the amount of the adhesive part having the third part. Therefore, the shape of the microneedles, and hence the projections of the microneedles, is unlikely to change, and the microneedles stuck in the puncture target are unlikely to come out of the puncture target.
- the concave container further includes a flange portion that extends outward from an edge of the opening.
- the lid portion further includes a flange facing portion that faces the flange portion, and the flange portion and the flange facing portion are connected to each other.
- the user picks the flange portion and the flange facing portion, and pulls the flange portion in a direction away from the flange facing portion, whereby the concave container and the lid portion are Can be disconnected. Therefore, the connection between the concave container and the lid is easily released.
- microneedle unit of the present disclosure an embodiment embodying the microneedle unit of the present disclosure will be described. Below, the whole structure of a microneedle unit, the structure of an adhesion part, the structure of a microneedle, the constituent material of a microneedle, and the effect
- the microneedle unit 10 includes a microneedle 11, a housing part 21, a lid part 31, and an adhesive part 41.
- the microneedle 11 includes a facing surface 12a that faces a puncture target into which the microneedle 11 is stabbed, and an adherend surface 12b that is a surface opposite to the facing surface 12a.
- One or more protrusions 13 are located on the facing surface 12a.
- the accommodating portion 21 is a concave container that accommodates the microneedle 11 and includes an opening 21 a surrounding the microneedle 11.
- the lid portion 31 has a plate shape that closes the opening 21 a of the housing portion 21 and is connected to the housing portion 21.
- the lid portion 31 extends from the adherend surface 12b of the base 12 of the microneedle 11 to the periphery of the adherend surface 12b and supports the adherend surface 12b.
- the bonding portion 41 bonds the lid portion 31 and the adherend surface 12b of the base 12.
- the accommodating part 21 receives a force in a direction away from the lid part 31 to release the connection with the lid part 31 in a state where the microneedle 11 is adhered to the lid part 31 by the adhesive part 41.
- the bonding portion 41 has a lid portion contact surface 41 a that contacts the lid portion 31.
- the adhesive portion 41 contacts the adherend surface 12b of the base 12 and extends from the adherend surface 12b to the periphery of the adherend surface 12b.
- a cover part contact surface 41a is peeled off from the lid 31.
- the lid contact surface 41a is an example of a first contact surface
- the target contact surface 41b is an example of a second contact surface.
- the base 12 of the microneedle 11 has a rectangular plate shape.
- the base 12 may have a disk shape, or may have a polygonal plate shape other than a rectangle.
- the area of the facing surface 12a in the substrate 12 may be equal to or larger than the area where one or more protrusions 13 can be located.
- the facing surface 12a of the base 12 has a planar shape.
- the facing surface 12a may have a curved surface shape, or may have both a planar shape and a curved surface shape.
- the adherend surface 12b of the base 12 has a planar shape.
- the adherend surface 12b may have a curved surface shape, or may have both a planar shape and a curved surface shape.
- a plurality of protrusions 13 are located on the facing surface 12 a of the base 12.
- the plurality of protrusions 13 are regularly arranged, for example, along a lattice shape.
- the plurality of protrusions 13 may be arranged irregularly, or even when the plurality of protrusions 13 are regularly arranged, they may be arranged in a close-packed state or arranged concentrically.
- Each protrusion 13 has a shape extending along the extending direction which is one direction, and has, for example, a quadrangular pyramid shape.
- the shape of each protrusion 13 is not limited to a quadrangular pyramid shape as long as it has a shape to pierce the puncture target, and may be, for example, another pyramid shape, a frustum shape, a columnar shape, or a blade shape. .
- each protrusion 13 has another cone shape, each protrusion 13 has a polygonal pyramid shape other than a conical shape or a quadrangular pyramid shape.
- each protrusion 13 has a frustum shape, each protrusion 13 only needs to have a truncated cone shape or a polygonal frustum shape.
- each protrusion 13 has a columnar shape, each protrusion 13 only needs to have a cylindrical shape or a polygonal column shape.
- Each protrusion 13 may have two or more shapes different from each other in the extending direction. In this case, the two included in the cone shape, the frustum shape, and the column shape described above. What is necessary is just to have the above shape.
- the outer peripheral surface of each protrusion 13 may have a twist or a step. In order for each protrusion 13 to pierce the puncture target, it is preferable that at least the tip of the protrusion 13 has a cone shape.
- the plurality of protrusions 13 may have different shapes, or the plurality of protrusions 13 may have different lengths in the extending direction. In order to facilitate the formation of the plurality of protrusions 13, it is preferable that the plurality of protrusions 13 have the same shape. Further, the plurality of protrusions 13 may extend along a direction intersecting with each other. When the plurality of protrusions 13 extend along a direction intersecting with each other, the tips of the adjacent protrusions 13 are mutually adjacent. Do not touch. Moreover, it is preferable that the front-end
- the base 12 may have one protrusion 13 on the facing surface 12a.
- the protrusion 13 may be located at the center of the facing surface 12a, or any one other than the center. It may be located at a site.
- the accommodating portion 21, which is an example of a concave container, includes a cylindrical body 23 having a square cylindrical shape, and a bottom 22 having a rectangular plate shape that closes one cylindrical end of the two cylindrical ends of the cylindrical body 23. Yes.
- the accommodating part 21 may have a hemispherical shape, may have a semi-ellipsoidal shape, or may have a polygonal cylindrical shape other than a quadrangle.
- the bottom portion 22 may have a curved plate shape that is recessed toward the opening 21a, or may have a curved plate shape that protrudes away from the opening 21a.
- the microneedle 11 is arranged at a position facing the center of the bottom portion 22 with respect to the accommodating portion 21.
- the microneedle 11 may be disposed at a position facing a portion other than the center in the bottom portion 22.
- the length along the extending direction in the accommodating part 21 is larger than the length along the extending direction in the microneedle 11.
- the accommodating part 21 has a flange part 24, and the flange part 24 extends toward the outside of the accommodating space 21b surrounded by the inner surface of the accommodating part 21 from the entire edge of the opening part 21a. That is, the flange portion 24 extends outward from the edge of the opening 21a from the edge of the opening 21a.
- the flange portion 24 may be located at a part of the edge of the opening 21a.
- the lid 31 has a rectangular plate shape.
- the lid part 31 may have a disk shape or a polygonal plate shape other than a rectangle.
- the area of the cover part 31 is larger than the area surrounded by the edge of the opening 21 a in the housing part 21.
- the microneedle 11 is located at the center of the lid 31 with respect to the lid 31.
- the microneedle 11 may be located at a portion other than the center of the lid portion 31.
- the housing portion 21 and the lid portion 31 may be connected to each other by being bonded with an adhesive, or may be connected to each other by being bonded by heat sealing.
- each of the accommodating portion 21 and the lid portion 31 has a fitting portion, and the fitting portion of the accommodating portion 21 and the fitting portion of the lid portion 31 are fitted to each other, thereby accommodating the accommodating portion 21 and the lid portion 31. May be connected to each other.
- the receiving portion 21 can release the connection with the lid portion 31 by receiving a force in a direction away from the lid portion 31.
- the flange facing portion 31 a facing the flange portion 24 is located on the surface of the lid portion 31 facing the accommodating portion 21.
- the area of the surface facing the accommodating part 21 is preferably equal to or larger than the area surrounded by the outer edge of the flange part 24.
- the flange facing portion 31 a is connected to the flange portion 24. Accordingly, the user can release the connection between the housing portion 21 and the lid portion 31 by picking the flange portion 24 and the flange facing portion 31a and pulling the flange portion 24 in a direction away from the flange facing portion 31a. it can. For this reason, the connection between the accommodating portion 21 and the lid portion 31 is easily released.
- the lid portion 31 includes an outer peripheral contact surface 31b, and when the protrusion 13 of the microneedle 11 is pierced by the puncture target, the outer peripheral contact surface 31b comes into contact with a portion of the puncture target that is located around the adhesive portion 41.
- the outer peripheral contact surface 31b is an example of a third contact surface.
- At least a part of the outer peripheral contact surface 31b has adhesiveness to the puncture target.
- the material which has the adhesiveness with respect to a puncture target may be sufficient as the formation material of the cover part 31, and the member which has adhesiveness with respect to a puncture target may be located in the outer peripheral contact surface 31b.
- the adhesive force of the outer peripheral contact surface 31b with respect to the puncture target is smaller than the adhesive force with respect to the puncture target in the portion of the target contact surface 41b located around the adherend surface 12b of the base 12.
- the outer peripheral contact surface 31b is also punctured together with a part of the adhesive portion 41 of the microneedle 11. Adhere to the object. Therefore, the microneedle 11 is stabbed into the puncture target in a state where the position of the microneedle 11 with respect to the puncture target is positioned by the outer peripheral contact surface 31b. Therefore, when the microneedle 11 receives a force in the direction of pressing against the puncture target, the microneedle 11 is likely to pierce the puncture target.
- the flange facing portion 31a in the lid portion 31 and the adhesive portion of the outer peripheral contact surface 31b may overlap each other.
- the part having adhesiveness in the outer peripheral contact surface 31b preferably has adhesiveness to the accommodating portion 21 and is preferably located in the entire outer peripheral contact surface 31b.
- an adhesive member that bonds the outer peripheral contact surface 31 b and the flange portion 24 may be positioned between the outer peripheral contact surface 31 b and the flange portion 24.
- the adhesive member that bonds the outer peripheral contact surface 31 b and the flange portion 24 is peeled off from the outer peripheral contact surface 31 b when the connection between the lid portion 31 and the accommodating portion 21 is released, and the flange portion 24.
- the member located in may be sufficient.
- the adhesive member may be a member that is peeled off from the flange portion 24 and located on the outer peripheral contact surface 31b when the connection between the lid portion 31 and the accommodating portion 21 is released.
- the flange facing portion 31 a in the lid portion 31 and the portion having adhesiveness to the puncture target on the outer peripheral contact surface 31 b may not overlap each other in the lid portion 31. That is, the lid portion 31 may have a flange facing portion 31a and a portion having adhesiveness to the puncture target on the outer peripheral contact surface 31b.
- the bonding portion 41 has, for example, a plate shape.
- the bonding force of the lid portion contact surface 41 a to the lid portion 31 is a lid portion bonding force.
- surroundings of the to-be-bonded surface 12b in the target contact surface 41b is target adhesive force.
- the lid adhesive strength is smaller than the target adhesive strength.
- the lid adhesive force is an adhesive force expressed by the entire area where the lid contact surface 41 a contacts the lid 31.
- the target adhesive force is an adhesive force expressed by the entire area of the portion located around the bonded surface 12b in the target contact surface 41b.
- the difference between the lid portion adhesive force and the target adhesive force is caused by the configuration listed below. That is, the difference between the two adhesive forces may be caused by a difference in adhesion target to which each surface adheres, may be caused by a difference in formation material of each surface, or may be caused by the difference between each surface and the adhesion target.
- the contact area may be different from each other, or may be generated by a combination thereof.
- the adhesion part 41 is composed of a plurality of layers that overlap in the extending direction, and the adhesion part 41 functions as a single laminate that adheres the lid part 31 and the adherend surface 12b of the base 12.
- the bonding portion 41 includes a lid portion contact portion 42 having a lid portion contact surface 41a that contacts the lid portion 31, and a target contact portion 43 having a target contact surface 41b that contacts the adherend surface 12b of the base 12 and the puncture target. It has.
- Each of the lid contact portion 42 and the target contact portion 43 has a layer shape.
- the lid contact portion 42 is an example of a first portion
- the target contact portion 43 is an example of a second portion.
- the target contact portion 43 extends from the adherend surface 12b of the base 12 to the periphery of the adherend surface 12b, and when the protrusion 13 is pierced by the puncture target, the portion of the puncture target that is located around the facing surface 12a It contacts with the target contact surface 41b with which the contact part 43 is provided.
- the material for forming the lid contact part 42 and the material for forming the target contact part 43 are preferably different from each other.
- the target contact part 43 has adhesiveness and has an adhesive force on the puncture target on the target contact surface 41b. Has adhesiveness.
- the adhesive part 41 is configured so that a part that expresses an adhesive force to the lid part 31 on the lid contact surface 41a and a part that expresses an adhesive force between the adhesive part 41 and the puncture target on the target contact surface 41b. Prepare. Therefore, the degree of freedom in the material for forming the bonding portion 41 is increased as compared with the configuration in which the bonding portion 41 is formed of a single layer.
- the lid portion adhesive force becomes smaller than the target adhesive force by adopting the following method.
- A As shown in FIG. 2, a portion of the inner surface of the lid portion 31 that contacts the lid portion contact surface 41 a that does not face the flange portion 24 included in the housing portion 21, that is, the lid of the adhesive portion 41 on the inner surface.
- the uneven part 31c is formed in the part which contacts the part contact surface 41a, for example by embossing. Thereby, the area which the cover part 31 and the adhesion part 41 contact is made smaller than the area which the puncture object and the adhesion part 41 contact.
- a silicone material or a fluorine-based material is applied to the inner side surface of the lid portion 31 that comes into contact with the lid portion contact surface 41a.
- materials having different adhesive forces are selected. In particular, it is preferable to select a forming material having a smaller adhesive force per unit area than the forming material of the target contact portion 43 as the forming material of the lid contact portion 42.
- an adhesive having an easy peel property that is, an easily peelable adhesive or an adhesive having a re-adhesive property may be selected.
- adhesive materials such as polyurethane materials, acrylic materials, polyvinyl chloride materials, polyvinylidene chloride materials, vinyl acetate materials, and silicone materials can be used.
- An easily peelable (easy peel type) adhesive such as an adhesive is preferred.
- the adhesive force between the lid contact surface 41a and the lid 31 per unit area is such that the target contact surface 41b per unit area is in contact with the puncture target and the puncture target. It may be larger than the adhesive force between the two. Even in this case, the lid adhesive force is smaller than the target adhesive force.
- the adhesive force between the lid contact surface 41a and the lid 31 per unit area is the unit between the portion that contacts the puncture target on the target contact surface 41b and the puncture target. It may be larger than the adhesive force per area. Even in this case, by performing the process of (B), the adhesive force between the lid contact surface 41a and the lid portion 31 causes the portion of the target contact surface 41b to contact the puncture target and the puncture target. It becomes possible to make it smaller than the adhesive force between.
- the material for forming the lid contact portion 42 and the material for forming the target contact portion 43 are polyurethane materials, acrylic materials, polyvinyl chloride. Adhesive materials such as a system material, a polyvinylidene chloride material, a vinyl acetate material, and a silicone material may be used.
- a polyurethane material an acrylic material, a polyvinyl chloride material, a polyvinylidene chloride material, a vinyl acetate material, and a silicone material
- An adhesive material such as can be used.
- the bonding portion 41 is positioned between the lid contact portion 42 and the target contact portion 43 in the direction in which the microneedle 11 and the puncture target face each other, that is, in the direction parallel to the extending direction.
- the support part 44 which has higher rigidity than the object contact part 43 and has a layer shape is further provided.
- the support portion 44 is an example of a third portion.
- the support portion 44 is positioned between the lid contact portion 42 and the base body 12, when the lid portion 31 and the target contact portion 43 are separated and the lid portion 31 is peeled off from the microneedle 11, the rigidity is increased.
- the high support portion 44 suppresses deformation of the target contact portion 43. Therefore, the shape of the base body 12 and thus the protrusion 13 is unlikely to change, and when the lid 31 is peeled off from the microneedle 11, the protrusion 13 of the microneedle 11 stuck in the puncture target is difficult to come out of the puncture target. .
- the support part 44 is, for example, a resin film formed of a material having rigidity higher than that of the target contact part 43, and the support part 44 is formed of a resin such as polyethylene, polypropylene, and polyethylene terephthalate. Resin film.
- the lid bonding force is smaller than the target bonding force by the following method.
- (D) By making the magnitude
- the adhesion part 41 may be comprised from a single layer.
- the adhesive force per unit area with respect to the lid portion 31 on the lid portion contact surface 41a is equal to the adhesive force per unit area with respect to the puncture target in the portion located around the adherend surface 12b on the target contact surface 41b. Also good. Even in such a case, the lid adhesive force becomes smaller than the target adhesive force by adopting at least one of the above-described (A) and (B).
- the composition in the extending direction may be constant in the bonding portion 41, or the composition may change along the extending direction.
- the forming material of the bonding portion 41 is a polyurethane material, an acrylic material, a polyvinyl chloride material, a polyvinylidene chloride material, a vinyl acetate material, and silicone. And other materials.
- FIG. 3 shows a cross-sectional structure of the microneedle unit 10 along a plane perpendicular to the surface in contact with the bonding portion 41 in the lid portion 31 and passing through the housing portion 21, the microneedle 11, and the bonding portion 41. ing.
- the height H of the protrusion 13 is a length along the extending direction, and the base 12 in the protrusion 13 from the facing surface 12 a of the base 12. It is the length to the tip which is the end away from.
- the protrusion 13 preferably has a height H suitable for forming a hole in the skin to be punctured, and the height H of the protrusion 13 is preferably included in the range of 10 ⁇ m to 1000 ⁇ m.
- the height H of the protrusion 13 is preferably set according to which part of the skin is located at the bottom of the hole formed in the puncture target.
- the height H of the protrusion 13 is preferably included in the range of 10 ⁇ m to 300 ⁇ m, and may be included in the range of 30 ⁇ m to 200 ⁇ m. More preferred.
- the height H of the protrusion 13 is preferably included in the range of 200 ⁇ m to 700 ⁇ m. And more preferably in the range of 200 ⁇ m or more and 500 ⁇ m or less.
- the height H of the protrusion 13 is further included in the range of 200 ⁇ m to 300 ⁇ m. preferable.
- the height H of the protrusion 13 is preferably included in the range of 200 ⁇ m to 500 ⁇ m.
- the height H of the protrusion 13 is preferably included in the range of 200 ⁇ m to 300 ⁇ m.
- the length in the direction orthogonal to the extending direction and the maximum value in the direction along the facing surface 12 a is the width D
- the width D of the protrusion 13 is 1 ⁇ m or more and 300 ⁇ m or less. It is preferable to be included in the range.
- the base end which is an end portion different from the distal end of the projecting portion 13, defines a square region on the facing surface 12a.
- the length of the diagonal line in the square area defined by the base end of the protrusion 13 is the width D of the protrusion 13.
- the base end of the protrusion 13 defines a circular region on the facing surface 12a.
- the diameter of the circular region defined by the base end of the protrusion 13 is the width D of the protrusion 13.
- the aspect ratio A of the protrusion 13 is preferably included in the range of 1 or more and 10 or less.
- the angle at the tip is the tip angle ⁇
- the tip angle ⁇ is a cross section in a direction perpendicular to the facing surface 12a of the base body 12. The maximum value of the angle formed by the protrusion 13.
- the tip angle ⁇ of the protrusion 13 is the top of an isosceles triangle with the diagonal line at the base end of the protrusion 13 as the base and the tip of the protrusion 13 as the apex. It is a horn.
- the tip angle ⁇ is included in the range of 5 ° to 30 °. It is preferable that it is contained in the range of 10 ° or more and 20 ° or less.
- the distance between the tip of the protrusion 13 and the portion of the housing portion 21 that faces the tip of the protrusion 13 is a separation distance L.
- the separation distance L is preferably in the range of 0.1 mm to 10 mm. In the configuration in which the separation distance L is 0.1 mm or more, when the microneedle unit 10 is transported, the tip of the protrusion 13 and the housing portion 21 come into contact with each other, and the tip of the protrusion 13 is deformed or damaged. It can be suppressed. Further, in the configuration in which the separation distance L is 10 mm or less, it is possible to prevent the space required for transportation and storage from being bulky when the microneedle unit 10 is transported or stored.
- the forming material of the microneedle 11 is a material having biocompatibility, that is, a material that exhibits a function as the microneedle 11 and does not negatively affect a puncture target to which the microneedle 11 is applied. Is preferred.
- the forming material of the microneedle 11 is a material having biocompatibility
- the forming material is, for example, silicon, metal, and resin.
- the forming material of the microneedles 11 is stainless steel, titanium, manganese, or the like.
- the forming material of the microneedles 11 is a resin
- the forming material is, for example, medical silicone, polylactic acid, polyglycolic acid, polycarbonate, and cyclic olefin copolymer.
- the forming material of the microneedle 11 may be a material that has biocompatibility and dissolves with a liquid that the microneedle unit 10 administers to the puncture target or a liquid that is administered to the puncture target from the outside. Good.
- the forming material is a material that dissolves in a liquid
- the forming material is, for example, a water-soluble polymer.
- water-soluble polymer examples include alginate, curdlan, chitin, chitosan, glucomannan, polymalic acid, collagen, collagen peptide, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, gelatin, chitosansuccinamide, trimethylchitosan, Oligo chitosan, oligo chitin, ethylene glycol chitosan, ethylene glycol chitin and the like.
- the forming material of the base 12 and the forming material of the protrusion 13 may be the same as each other or different from each other.
- the forming material of the protrusions 13 may be the same as or different from each other.
- the manufacturing method of the microneedle 11 may be any of various known methods.
- the manufacturing method of the microneedles 11 may be any one of, for example, an injection molding method, an extrusion molding method, an imprint method, a hot embossing method, and a casting method.
- the manufacturing method of the microneedle 11 may be any one of a machining method such as a cutting method and an etching method.
- the manufacturing method of the microneedle 11 may be a method of duplicating using an intaglio using the microneedle 11 as an original plate.
- the intaglio is produced by, for example, a plating method or a mold making method using a resin.
- the forming material of the housing part 21 is preferably a flexible material, and the forming material of the housing part 21 is, for example, a resin such as polyethylene, polypropylene, and polyethylene terephthalate.
- the forming material of the lid portion 31 is preferably a flexible material, and the forming material of the lid portion 31 is, for example, a resin such as polyethylene, polypropylene, and polyethylene terephthalate, as in the housing portion 21.
- the microneedle unit 10 may include a liquid drug administered to the skin or a liquid drug dissolved in a predetermined solvent.
- the microneedle unit 10 has a medicine accommodation space different from the accommodation space of the microneedle 11 in the lid portion 31 and holds the medicine in the medicine accommodation space. And what is necessary is just the structure which can supply a chemical
- the drug administered to the skin is a pharmacologically active substance or a cosmetic composition.
- the drug is appropriately selected according to the use of the user.
- the drug is, for example, a vaccine such as influenza, an anti-pain drug used by cancer patients, insulin, a biologic, a gene therapy drug, an injection, an oral preparation, and a skin application preparation. is there.
- transdermal administration using the microneedle unit 10 is a pharmacologically active substance other than the pharmacologically active substances conventionally used for percutaneous administration, and requires subcutaneous injection. It also applies to other pharmacologically active substances.
- transdermal administration using the microneedle unit 10 is preferably applied to children.
- the microneedle unit 10 when the drug is administered to the patient, the patient does not need to take the drug. Therefore, it is preferable that the microneedle unit 10 is applied to a child who is difficult to take an oral preparation.
- the cosmetic composition is a composition used as a cosmetic and a cosmetic, and when the drug is a cosmetic composition, the drug includes, for example, a moisturizer, a colorant, a fragrance, and a physiologically active substance exhibiting a cosmetic effect. It is.
- the physiologically active substance exhibiting a cosmetic effect include a substance having an effect of improving wrinkles, acne and pregnancy lines, a substance having an effect of improving hair loss, and the like.
- the container 21 and the lid 31 may hold an infusion liquid for administering the medicine to the skin separately from the medicine, and the infusion liquid may be an aqueous solvent such as water or ethyl alcohol, for example. Good.
- the injection liquid may be located inside the accommodating portion 21 in a state in which a porous material such as a gel material or a sponge is included.
- the formation material of the projection part 13 is a material which melt
- the formation material of the projection part 13 may contain the chemical
- the microneedle unit 10 before use has a configuration in which the protruding portion 13 and the injected liquid located inside the lid portion 31 are not in contact with each other, but when the microneedle unit 10 is used, the protruding portion It is preferable that the portion 13 and the injected liquid are in contact with each other.
- the forming material of the protrusion 13 may be a material that dissolves inside the skin to be punctured. In this case, the liquid accommodated in the lid portion 31 increases the speed at which the protrusion 13 is dissolved in the skin.
- the lid 31 When the lid 31 holds the above-described liquid medicine or injection liquid inside, the lid 31 has a through hole for allowing these liquids to enter the lid 31 from the outside of the lid 31. It is preferable. And after a liquid is put in the inside of the cover part 31, the through-hole of the cover part 31 should just be plugged up by the closure member which is located in the inside of a through-hole and plugs up a through-hole.
- the closing member has a cylindrical shape having two cylindrical ends, the end portion located on the outer surface of the lid portion 31 has an area larger than the area surrounded by the through-hole, It is preferable that the part which touches a side surface is located.
- the operation of the microneedle unit 10 will be described with reference to FIGS.
- the puncture target to be pierced by the microneedle 11 may be, for example, human skin or skin of an animal other than a human.
- action of the microneedle unit 10 is demonstrated using the structural example in which the cover part adhesive force is smaller than the object adhesive force in the microneedle unit 10.
- the user when the user uses the microneedle unit 10, the user releases the connection between the lid portion 31 and the storage portion 21 and removes the storage portion 21 from the microneedle unit 10. At this time, the microneedle 11 is in a state of being bonded to the lid portion 31 by the bonding portion 41. Since the accommodating portion 21 that covers the protruding portion 13 of the microneedle 11 is connected to the lid portion 31, when the accommodating portion 21 is removed from the microneedle unit 10, the microneedle 11 exerts a force that changes the shape of the microneedle 11. It is hard to receive.
- the shape of the base 12 of the microneedle 11 is changed, or the shape of the base 12 is changed, so that the protrusion 13 positioned on the base 12 can be prevented from touching the inner surface of the accommodating portion 21. Therefore, the user can easily handle the microneedle unit 10 when the user inserts the microneedle 11 into the puncture target.
- the user picks a portion of the lid portion 31 located around the adhesive portion 41 and places the microneedle 11 on the puncture target skin S.
- a portion of the lid portion 31 located around the adhesive portion 41 is positioned along the surface of the skin S.
- the microneedle 11 is covered with the lid portion 31, so that it is difficult for the user to touch the microneedle 11. Therefore, the user can easily handle the microneedle unit 10 when the user inserts the microneedle 11 into the puncture target.
- each protrusion 13 forms a hole in the skin S to be punctured.
- the outer periphery together with a part of the adhesion part 41 of the microneedle 11 The contact surface 31b is also adhered to the puncture target.
- the target contact portion 43 included in the bonding portion 41 has rigidity enough to be expanded by the force applied by the user, the target contact portion 43 is formed from the bonded surface 12b of the base 12 to the bonded surface 12b. Spread around. The target contact portion 43 is in close contact with the peripheral surface of the base 12 and the surface of the skin S.
- the user removes the lid 31 from the skin S.
- the user picks a part of the lid portion 31 and lifts the lid portion 31 from the surface of the skin S.
- the cover part 31 receives the force in the direction away from the puncture target, and the cover part 31 is peeled off from the cover part contact part 42.
- the microneedle unit 10 only the microneedle 11 and the adhesive portion 41 are located on the surface of the skin S.
- the microneedle 11 is covered with the lid portion 31 from when it is placed on the puncture target skin S to before the lid portion 31 is peeled off from the microneedle 11. Therefore, when the user pricks the microneedle 11 into the puncture target, the shape of the microneedle 11 is less likely to change compared to a configuration without a member that covers the microneedle 11. Therefore, the user can easily handle the microneedle unit 10 when the user inserts the microneedle 11 into the puncture target.
- the lid portion 31 that covers the microneedle 11 together with the microneedle 11 is also located on the surface of the skin S. Therefore, for example, when the microneedle 11 is prescribed on the skin S for a long time, such as when the forming material of the microneedle 11 is a drug, the user does not press the microneedle 11 against the skin S. Is prevented from peeling off.
- the microneedle 11 is used for forming a hole
- the user when the user removes the microneedle 11 from the skin S, the user only has to pick the adhesive portion 41. Therefore, the hole formed in the skin S by the user It becomes difficult to touch.
- Example 1 Manufacturing method of microneedle
- an original plate of the microneedle 11 was made from a silicon substrate by precision machining.
- 36 regular quadrangular pyramidal projections were formed on the silicon substrate.
- the height H was set to 150 ⁇ m
- the length of one side on the bottom surface was set to 60 ⁇ m.
- Each of the 36 protrusions was formed with an interval of 1 mm between each other, and was arranged in a grid of 6 columns and 6 rows.
- a nickel film having a thickness of 500 ⁇ m was formed on the original plate of the microneedle 11 formed from a silicon substrate by a plating method.
- the original plate was removed by wet etching using a 30 wt% aqueous potassium hydroxide solution heated to 90 ° C., and an intaglio plate made of nickel was produced.
- liquid hydroxypropylcellulose was supplied to the intaglio and solidified by heating the hydroxypropylcellulose with a heat source.
- the microneedle 11 was obtained by removing the solidified hydroxypropyl cellulose from the intaglio.
- a polyethylene terephthalate (PET) having a square cylindrical shape in which one of the two cylindrical ends is closed and having a flange portion in the entire circumferential direction of the opened cylindrical end. ) was used.
- PET polyethylene terephthalate
- the bonding part 41 having the lid part contact part 42, the target contact part 43, and the support part 44 sandwiched between the lid part contact part 42 and the target contact part 43 was formed.
- An easy-release silicone adhesive was used as the material for forming the lid contact portion 42
- an acrylic adhesive was used as the material for forming the target contact portion 43
- polyethylene was used as the material for forming the support portion 44.
- the lid portion 31 of the microneedle unit 10 a PET film having a rectangular plate shape was used. Then, the lid contact portion 42, the support portion 44, and the target contact portion 43 are overlapped to form the adhesive portion 41, and the microneedle 11 is placed at the center of the target contact portion 43, and the adhesive portion 41 is covered. Affixed to the inner surface of the part 31. Finally, the cover part 31 provided with the adhesion part 41 and the microneedle 11 and the accommodating part 21 were adhered with an adhesive.
- Example 2 Manufacturing method of microneedle
- an original plate of the microneedle 11 was made from a silicon substrate by precision machining.
- 36 regular quadrangular pyramidal projections were formed on the silicon substrate.
- the height H was set to 150 ⁇ m
- the length of one side on the bottom surface was set to 60 ⁇ m.
- Each of the 36 protrusions was formed with an interval of 1 mm between each other, and was arranged in a grid of 6 columns and 6 rows.
- a nickel film having a thickness of 500 ⁇ m was formed on the original plate of the microneedle 11 formed from a silicon substrate by a plating method.
- the original plate was removed by wet etching using a 30 wt% aqueous potassium hydroxide solution heated to 90 ° C., and an intaglio plate made of nickel was produced.
- liquid hydroxypropylcellulose was supplied to the intaglio and solidified by heating the hydroxypropylcellulose with a heat source.
- the microneedle 11 was obtained by removing the solidified hydroxypropyl cellulose from the intaglio.
- a polyethylene terephthalate (PET) having a square pillar shape in which one of the two cylindrical ends is closed and having a flange portion in the entire circumferential direction of the opened cylindrical end. ) was used.
- PET polyethylene terephthalate
- the bonding part 41 having the lid part contact part 42, the target contact part 43, and the support part 44 sandwiched between the lid part contact part 42 and the target contact part 43 was formed.
- An acrylic adhesive was used as the forming material of the lid contact portion 42
- an acrylic adhesive was used as the forming material of the target contact portion 43
- polyethylene was used as the forming material of the support portion 44.
- the lid portion 31 of the microneedle unit 10 As the lid portion 31 of the microneedle unit 10, a PET film having a rectangular plate shape with dot-like embossing on the inner surface was used. Then, the lid contact portion 42, the support portion 44, and the target contact portion 43 are overlapped to form the adhesive portion 41, and the microneedle 11 is placed at the center of the target contact portion 43, and the adhesive portion 41 is covered. It stuck on the inner surface which gave the embossing of the part 31. FIG. Finally, the cover part 31 provided with the adhesion part 41 and the microneedle 11 and the accommodating part 21 were adhered with an adhesive.
- the effects listed below can be obtained.
- the lid adhesive strength is smaller than the target adhesive strength, the lid 31 is easily peeled off from the microneedle 11.
- the outer peripheral contact surface 31b is also a part of the adhesive portion 41 of the microneedle 11 Adhere to the puncture target. Therefore, the microneedle 11 is stabbed into the puncture target in a state where the position of the microneedle 11 in the puncture target is positioned by the outer peripheral contact surface 31b. Therefore, when the microneedle 11 receives a force in the direction of pressing against the puncture target, the microneedle 11 is likely to pierce the puncture target.
- the bonding portion 41 is formed as compared with a configuration in which the two contact surfaces are formed of the same forming material. Increased freedom in materials.
- the user can release the connection between the housing portion 21 and the lid portion 31 by picking the flange portion 24 and the flange facing portion 31a and pulling the flange portion 24 in a direction away from the flange facing portion 31a. it can. For this reason, the connection between the accommodating portion 21 and the lid portion 31 is easily released.
- the embodiment described above can be implemented with appropriate modifications as follows.
- the adhesion part 41 does not need to have the support part 44. Even if it is such a structure, the effect according to (1) can be acquired at least as long as the cover part adhesive force is smaller than the target adhesive force in the adhesive part 41.
- the forming material of the lid contact surface 41a and the forming material of the target contact surface 41b may be the same. Even if it is such a structure, a cover part adhesive force becomes smaller than object adhesive force by employ
- the concave / convex portion 31 c may not be formed on the entire inner surface of the lid portion 31 that does not face the flange portion 24, and the concave / convex portion 31 c is the lid portion contact surface 41 a of the bonding portion 41 among the inner side surfaces. It may be formed only on the part that contacts the surface. Or the uneven
- the concavo-convex portion 31c may be formed in the lid portion 31 by the embossing described above, that is, a process in which a plurality of concave portions are repeatedly formed in the film or the like forming the lid portion 31, or the plurality of concave portions may be formed in other directions.
- the concavo-convex portion 31c may be formed by repeatedly forming. Or the uneven
- the convex portion may be formed, for example, by bonding a plurality of protrusions formed separately from the lid portion 31 to the lid portion 31, or another film or the like is pasted on the lid portion 31.
- lid part adhesive force smaller than object adhesive force by the easy method of forming a level
- the adhesive force mentioned above is implement
- the adhesive force of the lid contact portion 42 to the lid portion 31 may be greater than the adhesive force of the lid contact portion 42 to the support portion 44 and may be greater than the adhesive force of the target contact portion 43 to the support portion 44.
- the peeling adhesive force which is the smaller of the adhesive force of the lid contact portion 42 to the support portion 44 and the adhesive force of the target contact portion 43 to the support portion 44, is smaller than the target adhesive force.
- the adhesion force of the target contact surface 41 b to the skin is larger than the force required to increase the distance between the target contact surface 41 b and the lid portion 31.
- the adhesive force of the lid contact portion 42 to the support portion 44 may be an adhesive force for peeling.
- the target contact surface 41b maintains adhesion with the skin that is the puncture target, and the lid contact portion 42 and the support portion 44 Adhesion is released in between.
- the adhesive force of the target contact portion 43 to the support portion 44 may be an adhesive force for peeling.
- the target contact surface 41b maintains adhesion with the skin that is the puncture target, and between the target contact portion 43 and the support portion 44. Bonding is released at.
- the outer peripheral contact surface 31b may not have adhesiveness to the puncture target. Even if it is such a structure, the effect according to (1) can be acquired at least as long as the cover part adhesive force is smaller than the target adhesive force in the adhesive part 41.
- the lid adhesive force may be equal to or greater than the target adhesive force.
- the lid contact surface 41a is divided into a plurality of parts, the lid adhesive force may be equal to or greater than the target adhesive force. According to such a configuration, when the lid portion 31 is peeled off from the microneedle 11, the force for peeling the lid portion 31 from the microneedle 11 acts on each portion of the lid contact surface 41a. Part 31 is peeled off.
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Abstract
Description
経皮吸収法においては、マイクロニードルを皮膚に刺すことによって、皮膚の内部に薬剤などを投与する方法が提案されている。マイクロニードルは、投与対象に痛みを与えない程度の大きさを有した突起部を備え、突起部が皮膚のバリア層である角質層を貫通する。そして、マイクロニードルが皮膚に形成した孔から薬剤が皮膚の内部に吸収されることによって、薬剤が経皮吸収される。
本開示の技術におけるマイクロニードルユニットの他の態様によれば、2つの接触面が相互に異なる形成材料で形成されるため、2つの接触面が相互に同じ形成材料で形成される構成と比べて、接着部の形成材料における自由度が高まる。
本開示の技術におけるマイクロニードルユニットの他の態様によれば、蓋部に段差を形成するという容易な方法によって、蓋部に対する第1接触面の接着力を、第2接触面の中で被接着面の周囲に位置する部分の対象に対する接着力よりも小さくすることが可能になる。
図1を参照してマイクロニードルユニットの構成を説明する。
図1が示すように、マイクロニードルユニット10は、マイクロニードル11、収容部21、蓋部31、および、接着部41を備えている。マイクロニードル11は、マイクロニードル11が刺される穿刺対象と対向する対向面12aと、対向面12aとは反対側の面である被接着面12bとを備えている。対向面12aには、1以上の突起部13が位置している。
次に、図1および図2を参照して、マイクロニードルユニット10の備える接着部41を詳しく説明する。
(A)図2が示すように、蓋部接触面41aと接触する蓋部31の内側面のうち、収容部21の備えるフランジ部24と向かい合わない部分、すなわち、内側面における接着部41の蓋部接触面41aと接触する部分に、例えば、エンボス加工によって凹凸部31cを形成する。これにより、蓋部31と接着部41とが接触する面積を、穿刺対象と接着部41とが接触する面積よりも小さくする。
(C)蓋部接触部42の形成材料、および、対象接触部43の形成材料として、接着力が相互に異なる材料を選択する。特に、蓋部接触部42の形成材料として、対象接触部43の形成材料よりも単位面積当たりの接着力が小さい形成材料を選択することが好ましい。例えば、蓋部接触部42の形成材料として、イージーピール性、言い換えれば、易剥離性を有した接着剤や、再接着性を有した接着剤が選択されればよい。具体的には、ポリウレタン系材料、アクリル系材料、ポリ塩化ビニル系材料、ポリ塩化ビニリデン系材料、酢酸ビニル系材料、および、シリコーン系材料などの接着材料を用いることができ、中でも易剥離シリコーン系接着剤といった、易剥離グレード(イージーピールタイプ)の接着剤が好ましい。
(D)蓋部接触部42の大きさを、支持部44および対象接触部43の大きさよりも小さくすることで、蓋部接触部42を支持部44の一部にのみ接触させる。これにより、蓋部31と蓋部接触部42とが接触する面積を小さくする。
図3を参照してマイクロニードル11の構成を説明する。図3は、蓋部31における接着部41と接する面に直交する平面であって、収容部21、マイクロニードル11、および、接着部41を通る平面に沿ったマイクロニードルユニット10の断面構造を示している。
突起部13が少なくとも先端に錐体形状を有するとき、突起部13においては、先端における角度が先端角θであり、先端角θは、基体12における対向面12aと直交する方向に沿った断面にて、突起部13が形成する角度の最大値である。例えば、突起部13が正四角錐形状を有するとき、突起部13の先端角θは、突起部13の基端における対角線を底辺とし、かつ、突起部13の先端を頂点とする二等辺三角形の頂角である。
マイクロニードル11の形成材料は、生体適合性を有する材料、すなわち、マイクロニードル11としての機能を発現しつつ、マイクロニードル11が適用される穿刺対象に対して負の影響を与えない材料であることが好ましい。マイクロニードル11の形成材料が生体適合性を有する材料であるとき、形成材料は、例えば、シリコン、金属、および、樹脂などである。マイクロニードル11の形成材料が金属であるとき、形成材料は、ステンレス鋼、チタン、および、マンガンなどである。マイクロニードル11の形成材料が樹脂であるとき、形成材料は、例えば、医療用シリコーン、ポリ乳酸、ポリグリコール酸、ポリカーボネート、および、環状オレフィンコポリマーなどである。
図4から図7を参照してマイクロニードルユニット10の作用を説明する。なお、マイクロニードル11の刺される穿刺対象は、例えば、人の皮膚でもよいし、人以外の動物の皮膚でもよい。また、以下では、マイクロニードルユニット10において、蓋部接着力が対象接着力よりも小さい構成例を用いてマイクロニードルユニット10の作用を説明する。
マイクロニードル11が穿刺対象の皮膚Sの上に乗せられると、蓋部31のうち、接着部41の周囲に位置する部分が、皮膚Sの表面に沿って位置する。マイクロニードル11が皮膚Sの表面に乗せられるとき、マイクロニードル11は、蓋部31に覆われた状態であるため、使用者がマイクロニードル11に触れにくい。それゆえに、使用者がマイクロニードル11を穿刺対象に刺すとき、マイクロニードルユニット10の取り扱いが容易である。
マイクロニードル11は、穿刺対象の皮膚Sの上に乗せられるときから、マイクロニードル11から蓋部31が剥がれる前までの間にわたって蓋部31に覆われている。そのため、使用者がマイクロニードル11を穿刺対象に刺すとき、マイクロニードル11を覆う部材がない構成と比べて、マイクロニードル11の形状が変わりにくくなる。それゆえに、使用者がマイクロニードル11を穿刺対象に刺すとき、マイクロニードルユニット10の取り扱いが容易である。
[マイクロニードルの製造方法]
マイクロニードル11を製造するときには、まず、マイクロニードル11の原版を、精密機械加工によってシリコン基板から作成した。シリコン基板には、36本の正四角錐形状の突起部を形成し、各突起部においては、高さHを150μmに設定し、底面における一辺の長さを60μmに設定した。36個の突起部の各々を、相互に1mmの間隔を空けて形成し、かつ、6列6行の格子状に配列した。
マイクロニードルユニット10の収容部21として、2つの筒端のうち、一方が閉じられた四角筒形状を有し、かつ、開口した筒端の周方向の全体にフランジ部を有したポリエチレンテレフタレート(PET)製の容器を用いた。接着部41として、蓋部接触部42と、対象接触部43と、蓋部接触部42と対象接触部43とに挟まれる支持部44とを有する接着部41を形成した。蓋部接触部42の形成材料には、易剥離シリコーン系接着剤を用い、対象接触部43の形成材料には、アクリル系接着剤を用い、支持部44の形成材料には、ポリエチレンを用いた。
蓋部31がマイクロニードル11に接着した状態でブタの皮膚に蓋部31を押し付け、マイクロニードル11の突起部13をブタの皮膚に刺した。そして、蓋部31をブタの皮膚に押し付けるのを止め、蓋部31をブタの皮膚の上から取り除いた。蓋部31を取り除いても、マイクロニードル11と、マイクロニードル11を覆う接着部41とが、ブタの皮膚の上に残っていることが認められた。
[マイクロニードルの製造方法]
マイクロニードル11を製造するときには、まず、マイクロニードル11の原版を、精密機械加工によってシリコン基板から作成した。シリコン基板には、36本の正四角錐形状の突起部を形成し、各突起部においては、高さHを150μmに設定し、底面における一辺の長さを60μmに設定した。36個の突起部の各々を、相互に1mmの間隔を空けて形成し、かつ、6列6行の格子状に配列した。
マイクロニードルユニット10の収容部21として、2つの筒端のうち、一方が閉じられた四角柱形状を有し、かつ、開口した筒端の周方向の全体にフランジ部を有したポリエチレンテレフタレート(PET)製の容器を用いた。接着部41として、蓋部接触部42と、対象接触部43と、蓋部接触部42と対象接触部43とに挟まれる支持部44とを有する接着部41を形成した。蓋部接触部42の形成材料には、アクリル系接着剤を用い、対象接触部43の形成材料には、アクリル系接着剤を用い、支持部44の形成材料には、ポリエチレンを用いた。
蓋部31がマイクロニードル11に接着した状態でブタの皮膚に蓋部31を押し付け、マイクロニードル11の突起部13をブタの皮膚に刺した。そして、蓋部31をブタの皮膚に押し付けるのを止め、蓋部31をブタの皮膚の上から取り除いた。蓋部31を取り除いても、マイクロニードル11と、マイクロニードル11を覆う接着部41とが、ブタの皮膚の上に残っていることが認められた。
(1)マイクロニードル11に接着している蓋部31が穿刺対象に向かって押されることによって、突起部13が穿刺対象に刺さる。そして、突起部13が穿刺対象に刺さった後、マイクロニードル11が蓋部31から剥がされる。そのため、マイクロニードル11が穿刺対象に刺されるとき、使用者がマイクロニードル11に触れにくくなる。結果として、使用者がマイクロニードル11を穿刺対象に刺すとき、マイクロニードルユニット10の取り扱いがより容易になる。
(3)外周接触面31bの少なくとも一部が穿刺対象に対する粘着性を有する構成では、マイクロニードル11が穿刺対象に刺されるとき、マイクロニードル11の接着部41の一部とともに、外周接触面31bも穿刺対象に接着する。そのため、穿刺対象におけるマイクロニードル11の位置が外周接触面31bによって位置決めされた状態で、マイクロニードル11が穿刺対象に刺される。それゆえに、マイクロニードル11は、穿刺対象に対して押し付ける方向の力を受けたときに、穿刺対象に刺さりやすくなる。
・収容部21において、フランジ部24が省略されてもよく、この場合には、蓋部31のフランジ対向部31aが省略されてよい。こうした構成であっても、上述した(1)から(5)に準じた効果を得ることはできる。
Claims (8)
- マイクロニードルが刺される穿刺対象と対向する対向面と、前記対向面とは反対側の面である被接着面とを備え、前記対向面に1以上の突起部を有する前記マイクロニードルと、
前記マイクロニードルを収容する凹状容器であって、前記マイクロニードルを囲む開口部を備える前記凹状容器と、
前記開口部を塞ぐように前記凹状容器と接続する、板形状を有する蓋部であって、前記被接着面から前記被接着面の周囲に広がる前記蓋部と、
前記蓋部と前記被接着面との間に位置して、前記蓋部と前記被接着面とを接着する接着部と、を備え、
前記凹状容器は、前記蓋部から離れる方向の力を受けることによって、前記マイクロニードルが前記接着部によって前記蓋部に接着された状態で、前記蓋部との接続を解除するように構成され、
前記接着部は、前記蓋部に接触する第1接触面と、前記被接着面に接触し、かつ、前記被接着面から前記被接着面の周囲に広がり、前記突起部が前記穿刺対象に刺さるとき、前記穿刺対象の中で前記対向面の周囲に位置する部分と接触する第2接触面とを有している
マイクロニードルユニット。 - 前記接着部は、前記突起部が前記穿刺対象に刺さるとき、前記第2接触面の中で前記被接着面の周囲に位置する部分が前記穿刺対象に接着し、かつ、前記蓋部が前記穿刺対象から離れる方向の力を受けるとき、前記第1接触面が前記蓋部から剥がれるように、前記接着部が構成されている
請求項1に記載のマイクロニードルユニット。 - 前記接着部において、前記第2接触面の前記穿刺対象に対する接着力は、前記第2接触面と前記蓋部との間の距離を大きくすることに要する力よりも大きい
請求項1または2に記載のマイクロニードルユニット。 - 前記蓋部は、前記突起部が前記穿刺対象に刺さるとき、前記穿刺対象の中で前記接着部の周囲に位置する部分と接触する第3接触面を備え、
前記第3接触面の少なくとも一部は、前記穿刺対象に対する粘着性を有し、
前記穿刺対象に対する前記第3接触面の接着力は、前記第2接触面の中で前記被接着面の周囲に位置する部分の前記穿刺対象に対する接着力よりも小さい
請求項1から3のいずれか一項に記載のマイクロニードルユニット。 - 前記第1接触面の形成材料と前記第2接触面の形成材料とが相互に異なる
請求項1から4のいずれか一項に記載のマイクロニードルユニット。 - 前記蓋部は、前記第1接触面と接触する部分の少なくとも一部に複数の段差を有する
請求項1から5のいずれか一項に記載のマイクロニードルユニット。 - 前記接着部は、
前記第1接触面を有する第1部分と、
前記第2接触面を有する第2部分と、
前記マイクロニードルと前記穿刺対象とが対向する方向において、前記第1部分と前記第2部分との間に位置して、前記第2部分よりも剛性が高い第3部分と、をさらに備える
請求項1から6のいずれか一項に記載のマイクロニードルユニット。 - 前記凹状容器は、前記開口部の縁から外側に向けて延びるフランジ部をさらに備え、
前記蓋部は、前記フランジ部と対向するフランジ対向部をさらに備え、
前記フランジ部と前記フランジ対向部とが相互に接続する
請求項1から7のいずれか一項に記載のマイクロニードルユニット。
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JP2015559114A JP6489025B2 (ja) | 2014-01-24 | 2015-01-22 | マイクロニードルユニット |
EP15740221.5A EP3097943A4 (en) | 2014-01-24 | 2015-01-22 | Microneedle unit |
US15/217,540 US20160325082A1 (en) | 2014-01-24 | 2016-07-22 | Microneedle unit |
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JP2018191783A (ja) * | 2017-05-15 | 2018-12-06 | 富士フイルム株式会社 | マイクロニードルアレイユニット、および容器 |
US10786203B1 (en) * | 2018-01-30 | 2020-09-29 | Daniel M. Besser | Medical patch applicator device |
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US20160325082A1 (en) | 2016-11-10 |
EP3097943A1 (en) | 2016-11-30 |
JPWO2015111672A1 (ja) | 2017-03-23 |
EP3097943A4 (en) | 2017-09-13 |
JP6489025B2 (ja) | 2019-03-27 |
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