JP2019170690A - Continuous microneedle injection device - Google Patents

Abstract

To provide a continuous microneedle injection device suited for continuous injection of a medicine for a long time.SOLUTION: The continuous microneedle injection device comprises: a housing unit 4 housing a medical solution filler body 10; and needle unit 6 comprising a microneedle body 12. The needle unit 6 comprises: a needle holding member 70 with the microneedle body 12 mounted thereon; and a supply-feed flow path structure (supply-feed needles and supply-feed tubes) for guiding a medical solution 8 within the medical solution filler body 10 to the needle holding member 70; and when the housing unit 4 and the needle unit 6 are mounted to each other, the supply-feed flow path structure is communicatingly connected to the medical solution filler body 10 to allow the medical solution 8 within the medical solution filler body 10 to be supplied. When the continuous injection device is then affixed to the skin and the microneedle body 12 is stuck into the skin, the medical solution within the medical solution filler body 10 is continuously injected.SELECTED DRAWING: Figure 10

Description

  The present invention relates to a microneedle continuous injection device that continuously injects a liquid (for example, an active drug solution) into the skin using a microneedle.

  The number of elderly people, patients who have difficulty swallowing, etc. is increasing, and the quality of pharmaceuticals has changed, and drugs that must be injections are increasing. In such a situation, it is difficult to cope with conventional injections and tablets, and there is a need for a method of administering a drug that is simpler and less burdensome for the elderly and patients.

  For this reason, an attempt has been made to use a form such as an adhesive sheet, paste the adhesive sheet to the skin, and administer the drug contained in the adhesive sheet through the skin. However, in such a method, when the molecular weight of the drug exceeds 500, it cannot be entered from the skin, and when the molecular weight exceeds 400, it becomes extremely difficult to enter.

  In view of these circumstances, it has been newly proposed to inject a drug solution from the skin using a microneedle (see, for example, Patent Document 1). This microneedle injection and infusion device is composed of an injection assembly having microneedles and an infusion assembly in which a cartridge filled with a medicinal solution is accommodated, and the medicinal solution in the cartridge passes through a flexible tube to form a microneedle. The microneedle is injected into the skin.

JP-T-2006-523115

  However, since the microneedle injection and injection device injects the drug solution in the cartridge by moving the piston by a driving means such as a spring, the drug is injected into the body in a short time, thereby There is a problem that the concentration of the drug suddenly rises and side effects easily occur, resulting in a heavy burden on the body. In addition, there is a problem that the medicine in the cartridge tends to remain, the structure of the injection and infusion device itself is complicated and large, the price is high, and it is not suitable for disposable use.

  An object of the present invention is to provide a microneedle continuous injection device suitable for continuously injecting a drug over a long period of time.

  Another object of the present invention is to provide a microneedle continuous injection device that can be provided at a relatively low cost with a relatively simple structure and is easy to handle.

The microneedle continuous injecting device according to claim 1 of the present invention includes a storage unit that stores a chemical solution filling body filled with a chemical solution, and a needle unit that includes a microneedle for injecting the chemical solution into the skin. The accommodation unit and the needle unit are configured to be attached to each other,
The needle unit includes a needle holding member to which the microneedle is mounted, a needle housing that movably supports the needle holding member, and a feed flow for guiding the chemical liquid in the chemical liquid filling body to the needle holding member. The needle holding member is configured to be movable between a retracted position where the microneedle is retracted into the needle housing and an injection position protruding from an injection opening of the needle housing,
When the storage unit and the needle unit are attached to each other, the feed channel structure is connected to the chemical solution filling body so as to be fed, and the chemical solution in the chemical solution filling body is connected to the feed channel structure and the needle. The microneedle is fed through a holding member.

Moreover, the microneedle continuous injection device according to claim 2 of the present invention is a storage unit that stores a drug solution filling body that is filled with a drug solution, and a needle unit that includes a microneedle for injecting the drug solution into the skin. And is configured to be movable between a separation position where the accommodation unit is separated from the needle unit and a feeding position where the medicine is fed to the needle unit,
The needle unit includes a needle holding member to which the microneedle is mounted, a needle housing that movably supports the needle holding member, and a feed flow for guiding the chemical liquid in the chemical liquid filling body to the needle holding member. The needle holding member is configured to be movable between a retracted position where the microneedle is retracted into the needle housing and an injection position protruding from an injection opening of the needle housing,
When the storage unit is moved from the separation position to the feeding position, the feeding channel structure is connected in communication with the drug solution filling body so as to be fed, and the drug solution in the drug solution filling body is supplied to the feeding channel. The microneedle is fed through a structure and the needle holding member.

According to a third aspect of the present invention, there is provided a microneedle continuous injecting device comprising: a housing unit for housing a medicinal solution filling body filled with medicinal solution; and a needle unit comprising a microneedle for injecting the medicinal solution into the skin; Comprises the storage unit and the needle unit are attached to each other,
The needle unit includes a needle holding member to which the microneedle is mounted, a needle housing that movably supports the needle holding member, and a feed flow for guiding the chemical liquid in the chemical liquid filling body to the needle holding member. The needle holding member is configured to be movable between a retracted position where the microneedle is retracted into the needle housing and an injection position protruding from an injection opening of the needle housing,
When the needle holding member is moved from the retracted position to the injection position in a state in which the housing unit and the needle unit are mounted, the supply flow channel structure is connected in communication with the drug solution filling body so as to be capable of being supplied, The drug solution in the drug solution filling body is continuously injected through the feed channel structure, the needle holding member and the microneedle.

  Further, in the microneedle continuous injecting device according to claim 4 of the present invention, the feeding flow path structure includes a feeding needle attached to the needle housing so as to be movable toward the housing unit, and the feeding needle. A feed tube that communicates the feed needle with the needle holding member, and when the needle holding member is moved from the retracted position to the injection position in a state in which the housing unit and the needle unit are mounted, A part of the needle holding member acts on the feeding needle to pierce the chemical filling body so as to be fed, and the chemical liquid in the chemical filling body is fed with the feeding needle, the feeding tube, the needle holding member, and It is continuously injected through the microneedles.

  In the microneedle continuous injection device according to claim 5 of the present invention, the storage unit includes a storage housing that stores the drug solution filling body, and the liquid filling body is formed of a soft deformable material, A pressing member for pressing the chemical liquid filling body and a pressing biasing member for biasing the pressing member toward the chemical liquid filling body are disposed in the housing housing, and the inside of the chemical liquid filling body includes the pressing member. The chemical liquid is continuously injected through the feeding needle, the feeding tube, the needle holding member, and the microneedle using a pressing force applied to the pressing member by the pressing biasing member. And

  Moreover, in the microneedle continuous injecting device according to claim 6 of the present invention, the housing is provided with a support protrusion for supporting one end of the pressing member, and is associated with the pressing member. A holding release mechanism for holding and releasing the other end side is provided, and the holding release mechanism is provided between a holding angular position for holding the pressing member and a releasing angular position for releasing the holding of the pressing member. A holding release member that is rotatable is provided, and in a state in which the storage unit and the needle unit are mounted, the holding release member is held at the holding angular position, and the pressing member is the support of the storage housing. The protruding portion and the holding portion of the holding release member are held at a non-action separated position away from the chemical solution filling body, and the needle holding member is moved forward from the retracted position. When moved to the injection position, the needle holding member acts on the release portion of the holding release member and rotates to the release angle position, whereby the non-operating separation position by the holding portion of the holding release member is changed. The holding is released, and thus the pressing member acts on the drug solution filling body by the biasing action of the pressing biasing member.

Moreover, in the microneedle continuous injection device according to claim 7 of the present invention, the pressing force applied from the pressing member to the drug solution filling body by the pressing biasing member is 0.5 to 5.0 N / cm ^2. It is characterized by being.

  In the microneedle continuous injection device according to claim 8 of the present invention, the needle housing is provided with a guide portion for guiding the needle holding member, and the needle holding member is connected to the guide portion. First lock holding means for holding the retracted position is provided, and second lock holding means for holding the needle holding member at the injection position is provided.

  In the microneedle continuous infusion device according to claim 9 of the present invention, the needle insertion length of the microneedle into the skin is 0.3 to 3.0 mm.

  In the microneedle continuous injection device according to claim 10 of the present invention, the needle holding member is moved from the retracted position to the injection position with a driving force of 4 to 15 N, whereby the microneedle is It is characterized by being driven into the skin instantaneously.

  Moreover, in the microneedle continuous injecting device according to claim 11 of the present invention, the chemical solution filling body includes at least three layers of a polyethylene layer, an aluminum foil layer, and a polyester layer, and the feeding needle in the chemical solution filling body. The puncture site where the needle pierces is provided with a liquid leakage prevention layer for preventing liquid leakage or a needle puncture portion without liquid leakage.

  In the microneedle continuous infusion device according to claim 12 of the present invention, the chemical liquid filled in the chemical liquid filler is a medically acceptable aqueous solution, emulsified dispersion, or oily solution. To do.

  Furthermore, the microneedle continuous infusion device according to claim 13 of the present invention is characterized in that a physiological saline is added to and dissolved in the drug solution in the drug solution filler immediately before use of the drug solution filler.

  According to the microneedle continuous injecting device of the first aspect of the present invention, the microneedle continuous injection device is constituted by the storage unit and the needle unit, and these are attached to each other. At this time, these may be attached to each other. Therefore, the structure is relatively simple and can be provided at a low cost, and handling in use is easy.

  In addition, when the storage unit and the needle unit are attached to each other, the feed channel structure is connected to the drug solution filling body so as to be able to feed, so that the drug solution in the drug solution filling body passes through the feed channel structure and the needle holding member. The liquid is fed to the needle, and the feeding of the chemical liquid pushes out the air in the feeding flow path structure and the needle holding member. As a result, the chemical liquid can be smoothly injected into the skin.

  Moreover, according to the microneedle continuous injecting device of the second aspect of the present invention, the microneedle continuous injecting device is constituted by the housing unit and the needle unit, and the housing unit is movable between the separation position and the feeding position with respect to the needle unit. Even if configured in this manner, the housing unit and the needle unit may be manufactured separately and the housing unit may be moved from the separation position to the feeding position when used. Can be provided at a low cost and is easy to handle during use.

  Further, when the storage unit is moved from the separation position to the feeding position, the feeding flow path structure is connected to the chemical filling body so as to be able to feed, so that the chemical in the chemical filling body is held by the feeding flow path structure and the needle holding unit. It is fed to the microneedle through the member, and the feeding of the chemical liquid pushes out the air in the feeding flow path structure and the needle holding member, and as a result, the chemical liquid can be smoothly injected into the skin.

  Moreover, according to the microneedle continuous injecting device of the third aspect of the present invention, the microneedle continuous injecting device is constituted by the housing unit and the needle unit, and these are attached to each other. These may be attached to each other at the time of use. Therefore, the structure is relatively simple and can be provided at a low cost, and handling at the time of use is easy.

  The needle unit includes a needle holding member to which a microneedle is attached, a needle housing that movably supports the needle holding member, and a feed channel structure for guiding a chemical solution in the drug solution filling body to the needle holding member. When the needle holding member is moved from the retracted position to the injecting position, the feed channel structure is connected in communication with the drug solution filling body so that the needle holding member is moved toward the injecting position. With a simple operation, the drug solution in the drug solution filling body can be continuously injected into the skin through the feed channel structure, the needle holding member and the microneedle.

  According to the microneedle continuous injecting device according to claim 4 of the present invention, the feed flow path structure includes a feed needle that is movably attached to the needle housing toward the housing unit, a feed needle, and a needle. Since the feeding tube communicates with the holding member, when the needle holding member is moved from the retracted position to the injection position, a part of the needle holding member acts on the feeding needle and feeds it to the liquid medicine filling body. The drug solution in the drug solution filling body is continuously fed to the microneedle through the feed needle, the feed tube, and the needle holding member, and can be injected into the skin through the microneedle.

  According to the microneedle continuous injection device of the fifth aspect of the present invention, the pressing member and the pressing biasing member are disposed in the housing housing, and the pressing force applied by the pressing biasing member causes the pressing member to be pressed. Therefore, the chemical liquid in the chemical liquid filling body can be continuously fed to the microneedle little by little through the feeding needle.

  According to the microneedle continuous injection device of the sixth aspect of the present invention, the housing housing is provided with the support protrusion, the holding release mechanism is provided in association with the pressing member, and the holding release mechanism is held. Since the release member is rotatable between the holding angle position and the release angle position, the pressing member is separated from the chemical solution filling body by the support projection of the housing housing and the holding portion of the holding release member at the holding angle position. It can be held in a non-acting separation position. Further, when the needle holding member is moved from the retracted position to the injection position from this state, the needle holding member acts on the releasing portion of the holding releasing member and rotates to the releasing angular position, thereby holding the holding releasing member. The holding of the non-operation separation position by the part can be released.

Moreover, according to the microneedle continuous injecting device according to claim 7 of the present invention, the pressing force applied from the pressing member to the drug solution filling body by the pressing biasing member is 0.5 to 5.0 N / cm ² . Therefore, the chemical solution filled in the chemical solution filling body can be fed little by little to the microneedle and continuously infused into the skin for a long time.

  According to the microneedle continuous injection device of the eighth aspect of the present invention, the needle housing is provided with the guide portion, and the first and second lock holding means are provided in association with the guide portion. Therefore, the needle holding member can be locked and held at the retracted position by the first lock holding means, and the needle holding member can be locked and held at the injection position by the second lock holding means.

  Moreover, according to the microneedle continuous injection device of the ninth aspect of the present invention, since the needle insertion length of the microneedle into the skin is 0.3 to 3.0 mm, the tip of the microneedle is placed on the skin. The drug solution can be injected into the inside of the skin surface through the microneedles. In addition, this microneedle should just have at least 1 needle part, for example, may have two or more (for example, four, six, eight) needle parts. In the structure having a large number of needle parts, the chemical solution flows uniformly to each needle part, and is made to flow to each needle part after being equalized in a small space (for example, communication space) for equalizing the pressure. It is desirable to make it.

  According to the microneedle continuous injection device of the tenth aspect of the present invention, the needle holding member is instantaneously driven from the retracted position to the injection position with a driving force of 4 to 15 N. Can be stabbed to touch the skin instantaneously.

  According to the microneedle continuous injecting device of claim 11 of the present invention, the chemical solution filling body is composed of at least three layers of a polyethylene layer, an aluminum foil layer, and a polyester layer. The sealed chemical solution can be kept in a safe sealed state without alteration. Moreover, since the leak prevention layer is provided in the puncture site | part of the chemical | medical solution filling body, a liquid leak can be prevented also in the state which stabbed the feeding needle. As the leakage preventing layer, a highly sealing layer such as a butyl rubber layer, a synthetic rubber layer, or a polyisobutylene layer can be used.

  According to the microneedle continuous injecting device of the twelfth aspect of the present invention, the drug solution can be made gentle to the body (cells) by using an aqueous solution or an emulsified dispersion. In addition, by making the medicinal solution an oily solution, it is possible to avoid serious damage to the body and tissues and cells at the injection site when injected into the skin. What is used for this solution preparation is composed of a medically acceptable material, and the prepared liquid is also configured to ensure the storage stability with a predetermined storage strength.

  Furthermore, according to the microneedle continuous injecting device of the thirteenth aspect of the present invention, since physiological saline is added to and dissolved in the chemical solution in the chemical solution filling body immediately before use of the chemical solution filling body, the stability during storage of the chemical solution is stable. When there is a problem in sex, it can be provided as a solution to the problem.

The top view which shows one Embodiment of the microneedle continuous injection apparatus according to this invention. The side view shown in the state which mounted | wore the accommodation unit and needle unit in the microneedle continuous injection apparatus of FIG. The side view which shows the needle unit in the microneedle continuous injection apparatus of FIG. Sectional drawing which looked at the accommodation unit in the microneedle continuous injection apparatus of FIG. 1 from upper direction. Sectional drawing which looked at the accommodating unit of FIG. 4 from the side surface. The front view which shows the accommodation unit of FIG. Sectional drawing which shows the needle unit of FIG. 3 in a state when a needle holding member exists in a retracted position. Sectional drawing which shows the needle unit of FIG. 3 in the state when a needle holding member moves to an injection | pouring position. Sectional drawing shown in the state which mounted | wore the accommodation unit and the needle unit. Sectional drawing which shows a state when moving a needle holding member to the injection | pouring position from the state shown in FIG. Sectional drawing which shows the needle unit of a deformation | transformation form in a state when a needle holding member exists in a retreat position. Sectional drawing which shows the needle unit of FIG. 11 in the state when a needle holding member is moved to an injection | pouring position. Sectional drawing which shows the accommodation knit of a deformation | transformation form. The side view which shows other embodiment of the microneedle continuous injection apparatus according to this invention in the state when an accommodation unit exists in a separation position. The side view which shows the microneedle continuous injection apparatus of FIG. 13 in a state when an accommodation unit exists in a feeding position.

  Hereinafter, an embodiment of a microneedle continuous injection device according to the present invention will be described with reference to the accompanying drawings. 1 to 3, the illustrated microneedle continuous injection device 2 includes a storage unit 4 and a needle unit 6 that are attached to each other, and the storage unit 4 is filled with a chemical solution 8 (see FIG. 10). A drug solution filling body 10 (see FIGS. 4 and 5) is accommodated, and the needle unit 6 has a microneedle body 12 (also referred to as “microneedle”) for injecting the drug solution 8 into the skin (see FIGS. 7 and 8). ) Is provided.

  The accommodating unit 4 will be described with reference to FIGS. 4 and 5 as well. The illustrated accommodating unit 4 includes a rectangular accommodating housing 14, and the chemical solution filling body 10 is accommodated in the lower portion of the accommodating housing 14. A pressing member 16 for pressing the chemical liquid filling body 10 is disposed on the upper side of the chemical liquid filling body 10. The pressing member 16 is composed of a rectangular plate member that substantially corresponds to the outer shape of the chemical solution filling body 10.

  In relation to the pressing member 16, a support protrusion 20 that protrudes inward is provided on the inner surface of the rear wall 18 of the housing housing 14. The support protrusions 20 may be provided so as to extend linearly in the lateral direction of the rear wall 18 (the direction perpendicular to the paper surface in FIG. 5), or a plurality of support protrusions 20 are provided at intervals in the lateral direction. You may do it. Note that a part of the rear wall 18 (for example, a portion below the support protrusion 20) is configured as an opening / closing member (not shown), and the opening / closing member is opened to fill the chemical solution filler 10 in the housing housing 14. The opening / closing member may be provided on the bottom wall 23, the side wall or the like of the housing.

  A holding release mechanism 22 is provided on the front end side of the housing housing 14. The illustrated holding release mechanism 22 includes a substantially L-shaped holding release member 24. The holding release member 24 has a holding portion 26 on one end side and a releasing portion 28 on the other end side. The release portion 28 extends forward through an opening 32 provided in the front wall 30 of the housing housing 14. A pair of mounting brackets 25 are provided at the front end portion of the bottom wall 23 of the housing housing 14, and a base portion of the holding release member 24 is mounted between the pair of mounting brackets 25 via a pin member 27. The holding portion 26 extending in the direction extends to the center side in the width direction (upward and downward in FIG. 4). The holding release member 24 is rotatable about a pin member 27 between a holding angular position shown in FIG. 9 (an angular position also shown in FIGS. 4 and 5) and a releasing angular position shown in FIG.

  When the holding release member 24 is in the holding angular position, as shown in FIGS. 5 and 9, one end side (the rear end portion in the illustrated example) of the pressing member 16 is supported by the support protrusion 20 of the rear wall 18. The other end side (in the illustrated example, the front protrusion 17 provided at the front end) is supported by the holding portion 26 of the holding release member 24, and is thus supported by the support protrusion 20 and the holding release member 24. Held in the retracted position. In this retracted position, the pressing member 16 is positioned above the chemical solution filling body 10, and the pressing member 16 does not act on the chemical solution filling body 10. In order to hold the holding release member 24 at this holding angle position, a rotation blocking member (not shown) for preventing the rotation exceeding the holding angle position is provided, and further, this release holding member 24 is set to the holding angle position. You may make it provide the biasing spring (not shown) which elastically biases toward.

  When the holding release member 24 is rotated from the holding angle position to the release angle position as will be described later, as shown in FIG. 10, the holding portion 26 of the holding release member 24 is moved to the other end portion (the front protrusion portion) of the pressing member 16. 17), the pressing member 16 is placed on the drug solution filling body 10 such that one end portion (rear end portion) of the pressing member 16 slides down from the support protrusion 20 of the housing housing 14.

  In this embodiment, a coil spring 36 as a pressing biasing member is interposed between the upper wall 34 of the housing housing 14 and the pressing member 16, and the coil spring 36 directs the pressing member 16 toward the drug solution filling body 10. And elastically biased. Therefore, when the holding release member 24 is rotated to the release angle position, the pressing member 16 is pushed down by the action of the coil spring 36, thereby dropping from the support protrusion 20 of the housing housing 14 on one end side of the pressing member 16. Is promoted. The pressing member 16 is placed on the chemical solution filling body 10, and the chemical solution filling body 10 is elastically pressed through the pressing member 16 by the action of the coil spring 36. A plate spring, a disc spring, or the like may be used as the pressing bias member, or a piezoelectric element or the like may be used.

  In this embodiment, a lower protrusion 38 that protrudes toward the pressing member 16 is provided on the inner surface of the upper wall 34 of the housing housing 14, and an upper surface that protrudes toward the upper wall 34 is provided on the upper surface of the pressing member 16. A protrusion 40 is provided, and the coil spring 36 is mounted by fitting the lower protrusion 38 of the upper wall 34 and the upper protrusion 40 of the pressing member 16.

  As shown in FIGS. 1, 4, and 6, the housing 4 is provided with a pair of guide members 42 and 44 on both sides thereof. The pair of guide members 42, 44 extend forward from the housing housing 14, and guide protrusions 46, 48 that extend linearly to the front side are provided on the upper surfaces of the opposing inner surfaces, and the inner surfaces thereof. Locking protrusions 50 and 52 are provided in the lower part. In addition to the opening 32, an insertion hole 54 is provided in the front wall 30 of the housing 4. Instead of such a configuration, the locking protrusions 50 and 52 may be provided on the upper surface of the inner surface, and the guide protrusions 46 and 48 may be provided on the lower surface of the inner surface.

  The needle unit 6 attached to the housing unit 4 has the following configuration. The illustrated needle unit 6 includes a needle housing 62 attached to the housing housing 14. Both side walls 64 of the needle housing 62 are provided with guide grooves 65 (only one is shown in FIG. 3) corresponding to the guide protrusions 46 and 48 on the housing unit 4 side. 64 extends rearward from one end (the left end in FIG. 3) toward the other end, and corresponds to the locking protrusions 50 and 52 on the housing unit 4 side, and is provided on the lower side of the guide recess 65 with a locking recess. 66 (only one is shown in FIG. 3) is provided.

  Since it is configured in this way, the needle unit 6 is positioned between the pair of guide members 42 and 44 on the accommodation unit 4 side, and the needle unit 6 is close to the accommodation unit 4 as indicated by an arrow 68 (see FIG. 1). When the pair of guide protrusions 46 and 48 on the accommodation unit 4 side are moved relative to each other, the pair of guide protrusions 65 on the needle unit 6 side are received by the pair of guide recesses 65 on the needle unit 6 side. In this receiving state, when the needle unit 6 is further moved in the direction indicated by the arrow 68, the needle housing 62 is guided by the pair of guide members 42, 44, and the pair of guide recesses 65 is formed by the pair of guide protrusions. It is moved while being guided by the strips 46 and 48. 2 and FIG. 3, the lock projections 50 and 52 on the accommodation unit 4 side engage with the lock recesses 66 on the needle unit 6 side when moved to the mounted state (so-called use state) shown in FIGS. Thus, the accommodation unit 4 and the needle unit 6 can be mounted as required.

  In this embodiment, a pair of guide protrusions 46 and 48 are provided on the accommodation unit 4 side, and a pair of guide recesses 65 are provided on the needle unit 6 side. A pair of guide recesses 64 may be provided on the needle unit 6 and a pair of guide protrusions 46 and 48 may be provided on the needle unit 6 side. In this case, the pair of guide recesses 65 are provided at the tips of the pair of guide members 42 and 44. It is provided so as to extend backward from (the end on the needle unit 6 side). In addition, a pair of locking protrusions 50 and 52 are provided on the housing unit 4 side, and a pair of locking recesses 66 are provided on the needle unit 6 side. A concave portion 66 may be provided, and a pair of locking projections 50 and 52 may be provided on the needle unit 6 side.

  Next, the configuration of the needle unit 6 will be described in detail with reference to FIGS. 7 and 8. The illustrated needle unit 6 includes a needle holding member 70 movably attached to a needle housing 62. . The illustrated needle holding member 70 includes a rectangular main body portion 72, a cylindrical operation portion 74 provided on the upper surface of the main body portion 72, and a needle attachment portion 76 provided on the lower surface of the main body portion 72. The microneedle body 12 is attached to the needle attachment portion 76.

  In this embodiment, the inner surface of the upper wall 78 of the needle housing 62 is provided with four inner wall portions 82 (two of which are shown in FIGS. 7 and 8) for defining a rectangular mounting space 80. The inner wall portions 82 function as guide portions for guiding the needle holding member 70. The inner wall portions 82 extend downward, and a main body 72 of the needle holding member 70 is movably mounted inside the inner wall portions 82. The needle holding member 70 is in a retracted position (see FIG. 7). 9) to an injection position shown in FIG. 8 (position shown in FIG. 10). A circular opening 84 is provided at a substantially central portion of the upper wall 78, and the operation portion 74 of the needle holding member 70 protrudes upward through the opening 84.

  In relation to these inner wall portions 82 (ie, guide portions), the first lock holding means for holding the needle holding member 70 in the retracted position shown in FIG. 7 and the first lock holding means for holding in the injection position shown in FIG. 2 lock holding means. The first lock holding means is composed of first engagement recesses 85 provided on the four inner wall portions 82 and engagement protrusions 86 provided on the main body 72 of the needle holding member 70. When it is located, the engagement protrusion 86 on the needle holding member 70 side engages with the first engagement recess 85 on the inner wall portion 82 (guide portion) side. In this retracted position, as shown in FIGS. 7 and 9, the microneedle body 12 is housed in the needle housing 62, and the microneedle body 12 does not come into contact with the skin or the like.

  The second lock holding means includes a second engagement recess 88 on the inner wall 82 (guide) side and an engagement protrusion 86 on the needle holding member 70 side. The second engagement recess 88 is located below the first engagement recess 85 (that is, the microneedle body 12 side), and when the second engagement recess 88 moves to the injection position, the second engagement recess 88 on the inner wall portion 82 (guide portion) side. The engagement protrusion 86 on the needle holding member 70 side engages with the engagement recess 88. In this injection position, as shown in FIGS. 8 and 10, the tip of the microneedle body 12 protrudes from an opening 92 provided in the bottom wall 90 of the needle housing 62, and enters the surface of the skin where the drug solution 8 is to be injected. The drug solution 8 can be injected inside by being stabbed.

  The positioning of the needle holding member 70 at the injection position, that is, the driving of the microneedle body 12 into the skin is preferably performed using, for example, a driving tool 83 as shown in FIG. The illustrated driving tool 83 includes a driving housing 85, a driving member 87 that is movably mounted on the driving housing 85, and a driving biasing member (not shown) that elastically biases the driving member 87 downward. The driving member is configured to be movable between a retracted position indicated by a two-dot chain line in FIG. 9 and a driving position (not shown) for driving from the retracted position to the needle unit 6 side. In addition, in association with the driving member 87, a lock holding means (not shown) for locking and holding in the retracted position is provided, and a movement blocking member for blocking movement beyond the driving position is provided.

  When driving the microneedle body 12 using the driving tool 83, the driving housing 85 is placed on the upper wall 78 of the needle housing 62, and in this state, the pressing portion 89 of the driving member 87 is pressed with a finger to hold the lock. Release the lock. Then, the driving member 87 moves toward the driving position by the action of the driving biasing member, and the driving member 87 contacts the operation portion 74 of the needle holding member 70 by this movement and drives toward the skin. Will pierce the skin surface.

  In this embodiment, a coil spring 94 as a needle biasing member is interposed between the upper wall 78 of the needle housing 62 and the main body 72 of the needle holding member 70. The coil spring 94 elastically biases the needle holding member 70 downward, and the needle holding member 70 is elastically held at this injection position by this biasing force, and the microneedle body 12 (specifically, The tip part of the needle part 96 to be described later is held in a state of being pressed against the surface of the skin.

  The driving force applied to the needle holding member 70 (that is, the microneedle body 12) by the driving biasing member (not shown) of the driving tool 83 is preferably 4 to 15 N. The tip of the needle portion 96 of the needle body 12 is instantaneously driven into the skin with this driving force, and can be driven with less pain so as to come into contact with the skin. A contact protrusion 97 is provided on the bottom of the needle housing 62, and when the needle holding member 70 is driven, a part of the bottom surface contacts the contact protrusion 97, whereby the needle holding member Movement beyond the 70 injection position is reliably prevented.

  In this embodiment, the needle holding member 70 (microneedle body 12) is driven by the biasing action of the driving biasing member (not shown) of the driving tool 83, but the needle biasing member (for example, the coil spring 94) is driven. Alternatively, the needle holding member 70 (microneedle body 12) may be driven by the needle biasing member (coil spring 94).

  A feed needle 98 is disposed at the lower end of one end side (that is, the front end side) in the needle housing 62. A needle fixing portion 100 is provided on the bottom wall 90 of the needle housing 62, and a feeding needle 98 is fixed to the needle fixing portion 100. One end side (front end side) of the feeding needle 98 protrudes to the front side through an opening 104 provided in the front wall 102 of the needle housing 62, and for example, a protective tube 106 is attached to the protruding portion for safety. In use, the protective tube 106 is removed.

  For example, a tube made of butyl rubber can be used as the protective tube 106. In this case, it is not necessary to remove the protective tube made of butyl rubber in use, and it is used with the feeding needle 98 covered and filled with a chemical solution. It comes to pierce the body 10.

  In this embodiment, a communication space 108 is provided in the needle holding member 70 (specifically, the main body portion 72 and the needle mounting portion 76), and the feeding needle 98 and the communication space 108 communicate with each other via the feeding tube 110. The feed needle 98 and the feed tube 110 constitute a feed channel structure for guiding the drug solution 8 in the drug solution filling body 10 to the needle holding member 70.

  Further, the microneedle body 12 includes a needle main body portion 112 attached to the needle attachment portion 76 of the needle holding member 70 and a plurality (four in this embodiment) of needle portions 96 extending from the needle main body portion 112. Each needle hole 99 of the plurality of needle portions 96 communicates with the communication space 108 through the communication hole 101 provided in the needle main body portion 112.

  The microneedle body 12 (the plurality of needle portions 96) is highly safe for a living body and can be formed from any material that can be used in the medical field. However, the microneedle body 12 is easily broken when stabbed into the skin. Those that are likely to remain are not preferred. For this reason, the material may be, for example, a metal material (eg, stainless steel, brass, aluminum alloy, etc.), a plastic material (eg, polyester, polycarbonate, polypropylene, etc.), or a biodegradable polymer material. (For example, a polymer of lactic acid or glycolic acid, or a copolymer thereof) may be used.

  Since it is configured in this manner, the chemical solution 8 fed to the feeding needle 98 as described later is fed to the plurality of needle portions 96 through the communication space 108 of the feeding tube 110 and the needle holding member 70. The needles 96 are continuously injected into the skin through the needle holes 99. In addition, the number of the needle parts 96 of the microneedle body 12 should just be at least one, and can be suitably set by the injection amount etc. of the chemical | medical solution 8, etc., can provide 1-3 or 5 or more, for example, 3 Two to four sets of microneedle bodies 12 having four needle portions 96 may be provided.

  The penetration length of the plurality of needle portions 96 into the skin is preferably 0.3 to 3.0 mm. By setting the penetration depth to such a depth, the skin can be inserted without being deeply pierced into the skin. The medicinal solution 8 can be continuously injected into the inside little by little.

  As the chemical solution 8 to be injected into the skin, for example, the following can be used. As the chemical solution 8, an aqueous solution, an emulsified dispersion or an oily solution in which a drug (for example, a pharmaceutical product) is dissolved can be used. As these aqueous solution, emulsified dispersion or oily solution, medically acceptable ones are used. . Moreover, you may make it add physiological saline to the chemical | medical solution 8 just before use, and absorption of the chemical | medical solution 8 in the body can be accelerated | stimulated by adding physiological saline in this way.

Moreover, as a chemical | medical agent melt | dissolved in a chemical | medical solution, it can apply to the arbitrary active chemical | medical agents which can obtain a medicinal effect by subcutaneous injection. Examples of such drugs include physiologically active substances such as hormones, vaccines, etc., and nervous system drugs, diabetes drugs, analgesics, anticancer drugs (especially peptides, antibody drugs, immunopotentiators, nucleic acid drugs and Also called). Furthermore, various messengers that regulate the living body and substances derived therefrom are also included. Growth hormone releasing hormone (GHRH), growth hormone releasing factor (GHRF), insulin, insultropin, calcitonin, octreotide, endorphin, TRN, NT-36 (chemical name: N-[[(s) -4-oxo-2 -Azetidinyl] carbonyl] -L-histidyl-L-prolinamide), repressin, pituitary hormones (eg HGH, HMG, desmopressin acetate, etc.), follicular luteoid, aANF, growth factor releasing factor (GFRF) or FGF, EGF, PDGF Growth factors such as bMSH, GH, somatostatin, bradykinin, somatotropin, platelet-derived growth factor releasing factor, cholecystokinin, chorionic gonadotropin, erythropoietin, epoprostenol (platelet aggregation inhibitor), interferon α, in -Feron β, interferon γ, interleukin, interleukin-10 (IL-10), erythropoietin (EPO), granulocyte macrophage colony stimulating factor (GM-CSF), granulocyte colony stimulating factor (G-CSF), glucagon, corpus luteum Forming hormone-releasing hormone (LHRH), LHRH analogues (goserelin, leuprolide, buserelin, triptorelin, gonadorelin and nafarelin, such as menotropin (urofotropin (FSH) and LH)), oxytocin, streptokinase, tissue plasminogen activator Urokinase,
Examples of blood pressure-related drugs include vasopressin, deamino [Val4, D-Arg8] arginine vasopressin, desmopressin, corticotropin (ACTH), ACTH analogs such as ACTH (1-24), ANP, ANP elimination inhibitor, angiotensin II diuretic hormone agonist, etc. Furthermore, bradykinin antagonist, Seredace, CSI, calcitonin gene related peptide (CGRP), enkephalin, FAB fragment, IgE peptide inhibitor, IGF-1, neurotrophic factor, colony stimulating factor, parathyroid hormone and agonist, parathyroid hormone Antagonists, PTH analogs such as parathyroid hormone (PTH), PTH (1-34), prostaglandin antagonists, pentigetide, protein C, prote Down S, renin inhibitors, thymosin alpha-1, thrombolytics, TNF, vasopressin antagonist analogs, alpha-1 antitrypsin (recombinant) as well as well as TGF-beta.

  Further, for the purpose of immunization, antigens in the form of proteins, polysaccharide conjugates, oligosaccharides and lipoproteins can be mentioned. These subunit vaccines include Bordetella pertussis (recombinant PT axin-cell-free), Clostridium tetani (purified, recombinant), Corynebacterium diptheliae (purified, recombinant), site Megalovirus (glycoprotein subunit), group A streptococci (glycoprotein subunit, complex carbohydrate group A polysaccharide including tetanus toxoid, M protein / peptide bound to toxing subunit carrier, M protein, multivalent type Specific epitope, cysteine protease, C5a peptidase), hepatitis B virus (recombinant pre-S1, pre-S2, S, recombinant core protein), hepatitis C virus (recombinant-expressed surface protein) And epitope), human papillomavirus (capsid protein, TA-GN recombinant protein L2 and E7 [from HPV-6], MEDI-501 recombinant VLPL1 from HPV-11, tetravalent recombinant BLP L1 [from HPV-6 ], HPV-11, HPV-16 and HPV-18, LAMP-E7 [from HPV-16]), Legionella pneumophila (purified bacterial surface protein), Neisseria meningitidis (tetanus) Complex carbohydrates containing toxoids), Pseudomonas aeruginosa (synthetic peptides), rubella virus (synthetic peptides), Streptococcus pneumoniae ( Complex carbohydrates [1, 4, 5, 6B, 9N, 14, 18C, 19V, 23F] complexed with B OMP of Neisseria meningitidis, complex carbohydrates [4, 6B, 9V, 14, complexed with CRM197] 18C, 19F, 23F], glycoconjugate conjugated to CRM 1970 [1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F], Treponema pallidum (surface lipoprotein), shingles ( Also included are Varicella zoster virus (subunit, glycoprotein) and Vibrio cholerae (complex lipopolysaccharide).

  Examples of the drug include adrenaline, nicotine, bisphosphonate, and fentanyl.

  Moreover, the chemical | medical solution filling body 10 is comprised from the filling bag member 122 formed, for example from the film-like member, and the chemical | medical solution 8 is filled in this filling bag member 122. FIG. The filling bag member 122 preferably has at least a three-layer structure, that is, a polyethylene layer, an aluminum foil layer, and a polyester layer, in order to prevent the chemical solution 8 from being altered and to ensure its safety. If necessary, the thickness of the layer can be adjusted according to the medicine to be filled, a film layer of a new material can be additionally laminated, or the characteristics can be made suitable by vapor deposition or the like.

  Further, it is preferable to provide a liquid leakage prevention layer 124 (see FIGS. 4 and 5) on the surface side of the puncture site (the site where the feed needle 98 is punctured as described later) in the filling bag member 122. By providing the liquid leakage prevention layer 124 as described above, it is possible to prevent liquid leakage when the feeding needle 122 is pierced. As the liquid leakage prevention layer 124, a layer having high sealing properties such as a butyl rubber layer, a synthetic rubber layer, or a polyisobutylene layer can be employed.

  The thickness of the liquid leakage preventing layer 124 is at least 100 μm or more, preferably 200 μm or more. The thickness of the liquid leakage preventing layer 124 is preferably 5 mm or less, and preferably 3 mm or less, because if it is too thick, there will be a problem of bulkiness during storage. However, the thicker the sealing property, the more reliable, and it is not limited when the bulk problem does not occur. In place of the liquid leakage prevention layer 124, a needle puncture portion that does not leak the chemical solution 8 may be provided.

  The chemical solution filling body 10 is sterilized in advance, and the chemical solution is also sterilized and then filled in the sterilization chamber. Therefore, the chemical solution filling body 10 is manufactured in a sterilized manner. If there is no effect on the medicine, the filling bag member 122 may be filled and then sterilized by radiation.

  In such a microneedle continuous injection device 2, for example, the chemical solution 8 in the chemical solution filling body 10 is injected under the skin as follows, for example. Referring mainly to FIGS. 9 and 10, when injecting the drug solution 8, the protective tube 106 attached to the supply needle 98 on the needle unit 6 side is removed, and the separately prepared housing unit 4 and needle unit 6 ( Are attached to each other as shown in FIG. When mounted in this manner, the locking protrusions 50 and 52 (see FIG. 6) provided on the guide members 42 and 44 on the accommodation unit 4 side are in the locking recesses 66 provided on the needle housing 62 on the needle unit 6 side. The housing unit 4 and the needle unit 6 are held in the mounted state.

  In this mounted state, the supply needle 98 on the needle unit 6 side is inserted through the insertion hole 54 of the housing housing 14, and the tip portion thereof is stored in the revenue housing 14 (specifically, the liquid filling body 10. The leakage prevention layer 124) is pierced so as to be fed and is connected to the chemical solution filling body 10 so that the chemical solution 8 in the chemical solution filling body 10 gradually flows out through the feeding needle 98 due to the internal pressure thereof. Air in the feeding needle 98 and the feeding tube 110 is discharged through the communication space 108 of the needle holding member 70 and the plurality of communication holes 101 and needle holes 99 of the microneedle body 12.

  Further, when mounted in this way, as shown in FIG. 9, the release portion 28 of the holding release member 24 on the housing unit 4 side (at this time held at the holding angle position) is formed on the front wall 102 of the needle housing 62. Through the insertion opening 126 provided, the needle holding member 70 (at this time, held in the retracted position) extends to the main body 72 and is positioned below the main body 72, thus preparing for liquid injection.

  When injecting the chemical solution, an adhesive sheet 128 is applied to the bottom surface of the microneedle continuous injection device 2 (the bottom wall 23 of the housing unit 4 and the bottom wall 90 of the needle unit 6), and the release paper 130 is peeled off from the adhesive sheet 128 to remove the body. The microneedle continuous injection device 2 is attached to a predetermined part of the body in this way. The adhesive sheet 128 is provided with a through opening 132 corresponding to the opening 92 of the needle housing 62, and the adhesive sheet 128 is stuck so that the through opening 132 and the opening 92 of the needle housing 62 coincide with each other. At this time, an adhesive sheet 128 having a strong adhesive force is used so that the microneedle continuous injection device 2 can be securely fixed to the body.

  Instead of the above, a pressure-sensitive adhesive sheet (not shown) for the housing housing 14 is attached in advance to the bottom wall 23 of the housing housing 14 at the manufacturing stage of the housing knit 4, and the needle housing 62 is manufactured at the manufacturing stage of the needle unit 6. A pressure-sensitive adhesive sheet (not shown) for the needle housing 62 is affixed to the bottom wall 90 in advance, and when attached to the body, the release paper may be peeled off from the pressure-sensitive adhesive sheet and adhered to a predetermined part of the body. .

  After being attached to the body in this manner, the needle holding member 70 is pressed (or the needle holding member 70 is driven using the driving tool 83), and the chemical solution 8 is injected. When the operation portion 74 of the needle holding member 70 is pressed (or driven by the driving tool 83), as shown in FIG. 10, the needle holding member 70 moves downward from the retracted position along the inner wall portion 82 to the injection position. The engagement protrusion 86 on the needle holding member 70 side is engaged with the engagement recess 88 on the needle housing 62 side, and the needle holding member 70 is held at the injection position and is held by the needle holding member 70. A plurality of needle portions 96 of the needle body 12 protrude outward through the opening 92 of the needle housing 62 and the through-opening 132 of the adhesive sheet 128 and pierce the skin located in the inner region of the through-opening 132.

  When the needle moving member 70 moves to the injection position, the main body 72 of the needle holding member 70 acts on the release portion 28 of the holding release member 24 during this movement, and this is indicated by an arrow 134 (see FIG. 9). The holding release member 24 is positioned from the holding angular position to the release angular position. As a result, the holding member 24 is released from the retracted position by the holding release member 24, and the pressing member 16 is dropped to the upper side of the chemical solution filling body 10 by the action of the coil spring 36, and the elastic biasing force of the coil spring 36 The pressing member 16 presses the chemical solution filling body 10 (filled bag member 122).

  When the pressing force is applied in this way, the pressure is applied to the drug solution filling body 10 through the pressing member 16, and the drug solution 8 in the drug solution filling body 10 is pushed out through the feeding needle 98 by this pressure. Then, the chemical solution 8 pushed out from the chemical solution filling body 10 to the feeding needle 98 is fed to the communicating space 108 of the needle holding member 70 through the feeding tube 110, and each needle portion of the microneedle body 12 is passed through the communicating space 108. It distributes to 96 and is inject | poured little by little continuously under the skin through these needle parts 96. FIG. When the chemical liquid 8 is reduced by this feeding, the chemical liquid filling body 10 (filled bag member 122) is pressed and reduced by the pressing member 16 to which the biasing force from the coil spring 36 acts, and accordingly, the pressing member 16 Go down.

In such a microneedle continuous injection device 2, as easily understood, the unit time of the chemical solution 8 is adjusted by adjusting the biasing force (that is, the pressing force by the pressing member 16) by the coil spring 36 as the pressing biasing member. The injection amount per unit can be adjusted, and when this biasing force is increased (or decreased), the injection amount per unit time can be increased (or decreased). The biasing force (pressing force) by this biasing member (in this embodiment, the coil spring 36) is desirably 0.5 to ⁵ N / cm ² , and by setting such a biasing force (pressing force), The injection amount of the chemical solution 8 can be reduced, and the chemical solution 8 can be injected little by little continuously over a long time under the skin. The injection amount (injection speed) of the chemical solution 8 per unit time varies depending on the viscosity of the chemical solution 8, the number of the needle portions 96, the size of the needle hole 99, etc., and these factors are also taken into consideration. The biasing force (pressing force) 36 is adjusted. Moreover, the injection speed adjustment of the chemical solution 8 can also be performed by appropriately setting the size of the inner diameter of the feeding tube 110.

  In the above-described embodiment, when the accommodation unit 4 and the needle unit 6 are attached to each other, the feeding needle 98 on the needle unit 6 side is configured to pierce the filling bag member 122 so as to be fed. Instead of such a configuration, as shown in FIGS. 11 and 12, the feeding needle may be moved to the accommodation unit side and pierced into the drug solution filling body (filled bag member). 11 and 12, the same members as those in the above-described embodiment are denoted by the same reference numerals, and the description thereof is omitted.

  11 and 12, in the needle unit 6A of this modification, the needle support portion 100A is provided on the bottom wall 90 of the needle housing 62A, and the feed needle 98A uses the mounting member 142 on the needle support portion 100A. And is movably mounted on the housing unit (not shown) side.

  Further, in relation to the feeding needle 98A, a tilting action part 144 is provided in the main body part 72A of the needle holding member 70A. The tilting action portion 144 is linearly inclined inward toward the needle mounting portion 76, and the tilting action portion 144 is configured to act on the rear end portion (base end portion) of the feeding needle 98A. ing. Other configurations in this modification are the same as those in the above-described embodiment.

  In this modified needle unit 6A, in order to drive the microneedle body 12 into the skin, when the needle holding member 70A is moved from the retracted position shown in FIG. 11 to the injection position shown in FIG. Along with this, the tilting action portion 144 of the needle holding member 70A acts on the rear end portion of the feed needle 98A and is moved to the accommodation unit side, and by moving in this way, although not shown, The distal end portion is pierced so as to be fed into the chemical solution filling body (filled bag member) on the storage unit side and is connected in communication. Accordingly, when configured in this way, the feed needle 98A can be stabbed into the chemical solution filling body in accordance with the movement of the needle holding member 70A to the injection position, and the chemical solution in the chemical filling body can be fed. In addition, the needle can be fed to the plurality of needle portions 96 of the microneedle body 12 through the communication space 108 of the needle holding member 70A.

  Further, in the above-described embodiment, the holding release member 24 is provided in the storage unit 4, and this movement is performed when the needle holding member 70 is moved from the retracted position to the injection position in a state where the storage unit 4 and the needle unit 6 are mounted. However, instead of such a configuration, for example, as shown in FIG. 13, the holding release member 24 is rotated using the pressure and the pressure is applied to the medicine filling body 10 via the pressing member 16. It can also be configured.

  In FIG. 13, in the storage unit 4 </ b> B of this modification, a circular opening 152 is provided in the upper wall 18 </ b> B of the storage housing 14. The pressing member 16B is provided with a pressing protrusion 154 corresponding to the opening 152 of the upper wall 18B. The pressing protrusion 154 is configured to protrude upward through the opening 152. . Further, a rear support protrusion 20 is provided on the inner surface of the rear wall 18 of the housing housing 14, and a front support protrusion 156 is provided on the inner surface of the front wall 30. Other configurations of the housing unit 4B are the same as those in the above-described embodiment.

  Before injection of the chemical solution, as shown in FIG. 13, one side (rear end side) of the pressing member 16B is supported by the rear support projection 20, and the other side (front end side) is the front support projection. Therefore, the pressing member 16B is held in a retracted position above the chemical solution filling body 10, and the pressing protrusion 154 protrudes upward through the opening 152 of the upper wall 18B of the housing housing 14B. Yes.

  And when inject | pouring a chemical | medical agent, the press protrusion 154 is pressed and the support state by the support protrusions 20 and 156 is cancelled | released. That is, the pressing member 16B moves below the support protrusions 20 and 156 and is pressed downward by the biasing action of the pressing biasing member (coil spring 36), and the chemical liquid 8 in the chemical liquid filling body 10 is pressed by the pressing force. Sent as you did.

  Further, in the above-described embodiment, the storage unit 4 and the needle unit 6 are attached to each other and used in use. However, as shown in FIGS. 14 and 15, the storage unit and the needle unit are attached in advance, In use, the storage unit may be moved relative to the needle unit.

  14 and 5, the microneedle continuous injection device 2C is provided with a pair of guide members 42C (only one of them is shown in FIGS. 14 and 15) on both sides of the housing 14 of the housing unit 4C. It has been. The pair of guide members 42 </ b> C extend forward from the housing housing 14, and guide protrusions 46 </ b> C that extend linearly on the front side are provided on the upper surfaces of the opposing inner surfaces, and locks are provided on the lower surfaces of the inner surfaces. A protrusion 50C is provided.

  Corresponding to the above-described configuration on the housing unit 4C side, both side walls 64C of the needle housing 62C of the needle unit 6C (only one of them is shown in FIGS. 14 and 15) are guided on the housing unit 4 side. The guide recess 65C is provided corresponding to the strip 46C, and the lock first recess 66C and the lock first are provided below the guide recess 65C corresponding to the lock protrusion 50C on the housing unit 4C side. Two recesses 67C are provided. Other configurations of the microneedle continuous injecting device 2C of the other embodiment may be the same as those of the above-described embodiment (the embodiment shown in FIGS. 1 to 10).

  In the microneedle continuous injection device 2C, the accommodation unit 4C and the needle unit 6C are mounted in advance at the manufacturing stage, and are held in the state shown in FIG. That is, the pair of guide protrusions 46C on the storage unit 4C side are movably received in the corresponding guide recesses 65C on the needle unit 6C side, and the locking protrusions 50C on the storage unit 4C side are on the needle unit 6C side. It engages with the first locking recess 66C and is locked and held at the separation position shown in FIG. In this separated position, the accommodation unit 4C and the needle unit 6C are held in a separated state, and a feed needle (not shown) on the needle unit 6C side is attached to a chemical solution filling body (not shown) on the accommodation unit 4C side. There is no piercing.

  When the microneedle continuous injection device 2C is used, the housing unit 4C is moved relative to the needle unit 6C and positioned at the feeding position shown in FIG. During such relative movement, the needle unit 6C is moved between the pair of guide members 42C on the accommodation unit 4C side, and the pair of guide protrusions 46C on the accommodation unit 4C side is guided on the needle unit 6C side. When moved along the recess 65C and moved to this feeding position, the locking projection 50C on the accommodation unit 4C side engages with the second locking recess 67C on the needle unit 6C side, and the separation position shown in FIG. The lock is held. In this feeding position, the accommodation unit 4C and the needle unit 6C are held in a predetermined mounting state, and a feeding needle (not shown) on the needle unit 6C side is a chemical solution filling body (not shown) on the accommodation unit 4C side. The drug solution in the drug solution filling body is fed to the microneedle body (not shown) through the feed needle.

  In this embodiment, the pair of guide members 42C are provided on the housing 4C side. However, on the contrary, the pair of guide members 42C may be provided on the needle unit 6C side.

  As mentioned above, although one embodiment of the microneedle continuous injection device 2 according to the present invention has been described, the present invention is not limited to this embodiment, and various modifications or corrections can be made without departing from the scope of the present invention. It is.

  For example, in the above-described embodiment, the elastic biasing force is used by using the coil spring 36 as the pressing biasing member, but the magnetic biasing force is used by using a permanent magnet instead of such a configuration. In this case, one permanent magnet (first permanent magnet) is attached to the inner surface of the upper wall 34 of the housing housing 14, and the other permanent magnet is disposed on the upper surface of the pressing member 16 so as to face the permanent magnet. A magnet (second permanent magnet) is attached, and the first and second permanent magnets are arranged so as to magnetically repel each other.

  In the above-described embodiment, the elastic biasing force (pressing force) of the pressing biasing member is used to supply the chemical liquid 8 from the chemical liquid filling body 10, but instead of such a configuration, a micropump is used. You may make it operate | move and supply the chemical | medical solution 8, In this case, as a micro pump, a piezo micro pump, a micro tube pump, an electroosmotic flow pump etc. can be used, for example.

  Further, for example, in the above-described embodiment, the elastic biasing force is used by using the coil spring 94 as the needle biasing member, but instead of such a configuration, the magnetic biasing force is obtained by using a permanent magnet. In this case, one annular permanent magnet (first permanent magnet) is attached to the upper surface of the main body 72 (72A) of the needle holding member 70 (70A) and faces the annular permanent magnet. Thus, the other annular permanent magnet (second permanent magnet) is attached to the inner surface of the upper wall 78 of the needle housing 62, and these first and second permanent magnets are arranged so as to repel each other magnetically.

  Furthermore, in the above-described embodiment, the microneedle continuous injection device 2 is attached to the injection site of the body using the adhesive sheet 128. However, the microneedle continuous injection device 2 during the liquid injection is disconnected from the injection site. In order to prevent it more reliably, the microneedle continuous injection device 2 may be wound around the body with a bandage in this pasted state, or may be held on the body using a holding belt or the like.

2,2C microneedle continuous injection device 4,4B, 4C storage unit 6,6A, 6C needle unit 8 chemical solution 10 chemical solution filling body 12 microneedle body 14 storage housing 16, 16B pressing member 22 holding release mechanism 24 holding release member 26 holding Part 28 Release part 36 Coil spring (pressing biasing member)
62, 62A Needle housing 70, 70A Needle holding member 94 Coil spring (needle biasing member)
96 Microneedle 98 Feeding needle 108 Communication space 122 Filling bag member 128 Adhesive sheet 130 Release paper 144 Inclined action part

Claims (13)

A container unit containing a drug solution filled with a drug solution; and a needle unit including a microneedle for injecting the drug solution into the skin, so that the container unit and the needle unit are attached to each other. Is composed of
The needle unit includes a needle holding member to which the microneedle is mounted, a needle housing that movably supports the needle holding member, and a feed flow for guiding the chemical liquid in the chemical liquid filling body to the needle holding member. The needle holding member is configured to be movable between a retracted position where the microneedle is retracted into the needle housing and an injection position protruding from an injection opening of the needle housing,
When the storage unit and the needle unit are attached to each other, the feed channel structure is connected to the chemical solution filling body so as to be fed, and the chemical solution in the chemical solution filling body is connected to the feed channel structure and the needle. A microneedle continuous injection device, wherein the microneedle is fed to the microneedle through a holding member. A storage unit that stores a drug solution filling body filled with a drug solution; and a needle unit that includes a microneedle for injecting the drug solution into the skin; and a separation position at which the storage unit is spaced from the needle unit; It is configured to be movable between a feeding position for feeding the medicine to the needle unit,
The needle unit includes a needle holding member to which the microneedle is mounted, a needle housing that movably supports the needle holding member, and a feed flow for guiding the chemical liquid in the chemical liquid filling body to the needle holding member. The needle holding member is configured to be movable between a retracted position where the microneedle is retracted into the needle housing and an injection position protruding from an injection opening of the needle housing,
When the storage unit is moved from the separation position to the feeding position, the feeding channel structure is connected in communication with the drug solution filling body so as to be fed, and the drug solution in the drug solution filling body is supplied to the feeding channel. A microneedle continuous injection device, wherein the microneedle is fed to the microneedle through a structure and the needle holding member. A container unit containing a drug solution filled with a drug solution, and a needle unit including a microneedle for injecting the drug solution into the skin, so that the container unit and the needle unit are attached to each other Configured,
The needle unit includes a needle holding member to which the microneedle is mounted, a needle housing that movably supports the needle holding member, and a feed flow for guiding the chemical liquid in the chemical liquid filling body to the needle holding member. The needle holding member is configured to be movable between a retracted position where the microneedle is retracted into the needle housing and an injection position protruding from an injection opening of the needle housing,
When the needle holding member is moved from the retracted position to the injection position in a state in which the housing unit and the needle unit are mounted, the supply flow channel structure is connected in communication with the drug solution filling body so as to be capable of being supplied, The microneedle continuous injection device, wherein the chemical liquid in the chemical liquid filling body is continuously injected through the supply flow channel structure, the needle holding member and the microneedle.   The feed flow path structure includes a feed needle that is movably attached to the needle housing toward the accommodation unit, and a feed tube that communicates the feed needle and the needle holding member. When the needle holding member is moved from the retracted position to the injection position in a state where the housing unit and the needle unit are mounted, a part of the needle holding member acts on the feeding needle and the chemical solution 4. The liquid medicine is inserted into the filling body so as to be able to be fed, and the chemical liquid in the chemical filling body is continuously injected through the feeding needle, the feeding tube, the needle holding member and the microneedle. The microneedle continuous injection apparatus described in 1.   The storage unit includes a storage housing for storing the chemical liquid filler, the liquid filler is formed of a soft deformable material, and a pressing member for pressing the chemical liquid filler in the storage housing; A pressing biasing member for biasing the pressing member toward the chemical liquid filling body is provided, and the chemical liquid in the chemical liquid filling body has a pressing force applied to the pressing member by the pressing biasing member. The microneedle continuous injection device according to claim 1, wherein the microneedle continuous injection device is continuously injected through the supply needle, the supply tube, the needle holding member, and the microneedle. .   The housing is provided with a support protrusion for supporting one end of the pressing member, and a holding release mechanism for holding and releasing the other end in relation to the pressing member. The holding release mechanism includes a holding release member that is rotatable between a holding angle position that holds the pressing member and a release angle position that releases the holding of the pressing member, and the housing unit and the In a state where the needle unit is mounted, the holding release member is held at the holding angular position, and the pressing member is separated from the chemical solution filling body by the support protrusion of the housing housing and the holding portion of the holding release member. When the needle holding member is moved to the injection position from the retracted position, the needle holding member is held at the non-operation separated position, and the holding release member is moved. It acts on the release portion and rotates to the release angle position, whereby the holding portion of the holding release member is released from being held at the non-operating separation position, and thus the pressing member of the pressing biasing member is released. 6. The microneedle continuous injection device according to claim 5, wherein the microneedle continuous injection device acts on the drug solution filling body by a biasing action. Pressing force applied to the drug solution filling member from the pressing member by the pressing biasing member, microneedles continuous according to claim 5 or 6, characterized in that a 0.5~5.0N / cm ² Injection device.   The needle housing is provided with a guide portion for guiding the needle holding member, and in association with the guide portion, first lock holding means for holding the needle holding member in the retracted position is provided. The microneedle continuous injection device according to any one of claims 1 to 3, further comprising second lock holding means for holding the needle holding member at the injection position.   The microneedle continuous infusion device according to any one of claims 1 to 3, wherein a needle insertion length of the microneedle into the skin is 0.3 to 3.0 mm.   The needle holding member is moved from the retracted position to the injecting position with a driving force of 4 to 15 N, whereby the microneedle is instantaneously driven into the skin. The microneedle continuous injection apparatus according to any one of the above.   The liquid medicine filling body is composed of at least three layers of a polyethylene layer, an aluminum foil layer, and a polyester layer, and a liquid leakage preventing layer for preventing liquid leakage at a puncture site of the liquid medicine filling body where the feeding needle pierces. Or the needle puncture part which a chemical | medical solution does not leak is provided, The microneedle continuous injection apparatus in any one of Claims 1-3 characterized by the above-mentioned.   The microneedle continuous injection device according to any one of claims 1 to 3, wherein the chemical liquid filled in the chemical liquid filling body is a medically acceptable aqueous solution, emulsified dispersion, or oily solution. The microneedle continuous injection device according to any one of claims 1 to 3, wherein a physiological saline is added to and dissolved in the chemical solution in the chemical solution filling body immediately before use of the chemical solution filling body.

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