WO2020045588A1 - マイクロニードルアプリケータ - Google Patents

マイクロニードルアプリケータ Download PDF

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Publication number
WO2020045588A1
WO2020045588A1 PCT/JP2019/033987 JP2019033987W WO2020045588A1 WO 2020045588 A1 WO2020045588 A1 WO 2020045588A1 JP 2019033987 W JP2019033987 W JP 2019033987W WO 2020045588 A1 WO2020045588 A1 WO 2020045588A1
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WO
WIPO (PCT)
Prior art keywords
housing
button
microneedle
puncture
movable cylinder
Prior art date
Application number
PCT/JP2019/033987
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
美浪 川邉
保紀 土取
悠太 藤原
Original Assignee
ニプロ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from JP2018161450A external-priority patent/JP7448306B2/ja
Priority claimed from JP2018161323A external-priority patent/JP7099189B2/ja
Priority claimed from JP2018161449A external-priority patent/JP7172293B2/ja
Application filed by ニプロ株式会社 filed Critical ニプロ株式会社
Priority to CN201980056800.6A priority Critical patent/CN112888474A/zh
Priority to KR1020217005842A priority patent/KR20210086599A/ko
Publication of WO2020045588A1 publication Critical patent/WO2020045588A1/ja

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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
    • 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
    • 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
    • A61M37/0069—Devices for implanting pellets, e.g. markers or solid medicaments
    • 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
    • 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
    • A61M2037/0061—Methods for using microneedles
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8275—Mechanical
    • A61M2205/8281—Mechanical spring operated

Definitions

  • the present invention relates to a microneedle applicator that can puncture the skin of a microneedle that transmits a drug or the like percutaneously.
  • transdermal drug administration methods such as subcutaneous injection and intravenous injection have been known.
  • the administration of transdermal drugs by such injections has advantages such as faster effects and not being decomposed by enzymes, etc., compared to, for example, oral drug administration, but is invasive, It was often painful.
  • a transdermal drug administration method using a fine needle has been proposed. That is, the drug is transdermally administered by puncturing the skin with the microneedle coated with the drug or piercing the skin with the hollow microneedle and injecting the drug through the lumen provided in the microneedle. Can be done.
  • a drug administration method using a microneedle transcutaneous treatment with less pain has been made possible.
  • a microneedle applicator as described in Japanese Patent Application Publication No. 2016-519983 (Patent Document 1) is known.
  • a microneedle applicator has a puncture rod that holds a microneedle at the time of puncture, a housing having the puncture rod inside, and a movable cylinder that is movable with respect to the housing. Then, for example, the puncture rod is pushed into the housing to compress an elastic member such as a coil spring, and at the same time, the applicator is pressed against the skin to move the movable cylinder toward the housing. Thereby, the microneedle is set in a state where it can be punctured, and the compression of the elastic member is released from such a state, whereby the puncture rod projects and the microneedle is punctured.
  • the conventionally proposed microneedle applicator has sufficient measures against puncture by mistake.
  • the applicator is pressed against the skin before the puncture rod is pushed into the housing, the movable cylinder is pushed into the housing side, and the microneedle provided on the puncture rod is applied to the applicator.
  • the skin protruded from the skin and unintentionally punctured the skin.
  • a problem to be solved by the present invention is to provide a novel microneedle applicator that is effective in preventing unintended puncture of a microneedle.
  • a microneedle applicator in which a microneedle can be punctured by pushing a puncture rod into a housing and moving a movable cylinder toward the housing, the movable cylinder moves toward the housing.
  • Movement restricting means for preventing movement of the movable cylinder toward the housing by releasing the movement restricting means with the pushing operation of the puncture rod into the housing. Is what it is.
  • the movement restricting means is released when the puncture rod is pushed into the housing, whereby the movable cylinder is allowed to move toward the housing. Therefore, the movable cylinder is prevented from moving toward the housing before the operation of pushing the puncture rod into the housing, and erroneous puncture of the microneedle can be prevented.
  • the movement restricting means is configured by a lock member that prevents the movable cylinder from moving toward the housing by contacting the movable cylinder.
  • the release means the contact between the lock member and the movable cylinder is released by pushing the puncture rod into the housing.
  • the movement restricting means for preventing the movement of the movable cylinder by providing the lock member and making contact with the movable cylinder is configured, and the puncture rod is pushed in to contact the movable cylinder.
  • release means is configured to release the movement restriction means and allow the movable cylinder to move.
  • the lock member is arranged so as to be movable in a direction intersecting with a pushing direction of the puncture rod. The prevention of movement by contact with the movable cylinder and the permission of movement by release of contact are selectively realized.
  • the contact with the movable cylinder is released by the movement of the lock member, and the movement of the movable cylinder is allowed.
  • the movable direction of the lock member intersects the pushing direction of the puncture rod, the pushing force of the puncture rod can be more efficiently blocked by the lock member.
  • a fourth aspect is the microneedle applicator according to the first aspect, wherein the movement restricting means is constituted by a cap which covers the puncture rod from outside, and the release means is constituted by a structure for removing the cap. Is what is being done.
  • the pushing of the puncture rod and the movement of the movable cylinder are not allowed unless the cap is removed, so that the unintended movement of the movable cylinder can be more reliably prevented.
  • the movement restricting means includes a cover that covers at least a part of the movable cylinder. .
  • microneedle applicator of this aspect by providing a cover that covers the movable cylinder and can prevent the movable cylinder from moving toward the housing, unintended movement of the movable cylinder can be more reliably prevented.
  • a sixth aspect is the microneedle applicator according to any one of the first to fifth aspects, wherein the microneedle is attachable to the movable cylinder, and is detachable for covering the puncture rod from outside.
  • the microneedle cannot be attached to the movable cylinder by attaching a simple cap to the housing.
  • the movable cylinder is mounted on the housing with the microneedle mounted on the applicator. Inadvertent movement to the side and erroneous puncture can also be prevented.
  • a safety mechanism for disabling a puncture button for puncturing the microneedle is provided, and The safety mechanism is released by moving the cylinder toward the housing.
  • the movable cylinder is moved to the housing side, that is, for example, the microneedle puncture operation can be performed by pressing the applicator against the skin. It is also possible to prevent the microneedles from protruding at the same time.
  • the microneedle is projected from the housing by a biasing means, and is projected from the housing by the biasing means.
  • the microneedle is provided with a buffering external force applying mechanism for continuously applying an external force in the protruding direction to the microneedle via the buffering means.
  • the microneedle applicator of the present aspect since an additional external force is continuously applied to the microneedle protruding from the housing and piercing the skin, the piercing state of the microneedle to the skin is maintained. The stabilization of transdermal administration of the drug can be achieved. Further, since an additional external force is applied to the punctured microneedle via the buffer means, the effect of the impact force on the microneedle is reduced, and the patient's discomfort such as pain can be reduced.
  • a ninth aspect is the microneedle applicator according to the eighth aspect, wherein the buffering external force applying mechanism includes an additional external force generating member that generates the additional external force, and the buffering external force generating mechanism generates the additional external force.
  • the applied external force is exerted on the microneedle via the buffer means.
  • the external force generating member since the external force generating member is provided, the user does not need to apply a large external force from outside.
  • a tenth aspect is the microneedle applicator according to the ninth aspect, wherein the additional external force generating member is configured by a compression spring member that generates the additional external force by being maintained in a compressed state, The additional external force of the compression spring member is applied to the buffer means via a pressing force transmitting member, and a movement lock mechanism for preventing movement of the pressing force transmitting member is provided so as to be releasable. Is what it is.
  • microneedle applicator of this aspect it is possible to control the action of the applied external force on the microneedle using the pressing force transmitting member.
  • the buffering external force applying mechanism includes an additional external force operating member that applies the additional external force by an external operation.
  • the additional external force exerted by the member is exerted on the microneedle via the buffer means.
  • the external force applied from the outside through the external force operating member can be appropriately and easily changed or adjusted.
  • an operation lock mechanism for preventing operation of the additional external force operation member is provided so as to be releasable.
  • the operation lock mechanism can prevent unintended addition of the additional external force by the additional external force operation member.
  • a thirteenth aspect is the microneedle applicator according to the eleventh or twelfth aspect, wherein an external operation surface of the additional external force operation member enters at least from a surface of the housing in a storage state before puncturing. It is set at the position where
  • the buffer means is formed of an elastic member different from the urging means.
  • the elasticity of the cushioning means and the urging means can be set individually. As a result, the design flexibility of the applicator can be improved.
  • 15A fifteenth aspect is the microneedle applicator according to any one of the eighth to thirteenth aspects, wherein the buffer means is constituted by the urging means.
  • the buffering means and the urging means are constituted by the same member, so that the structure can be simplified and the number of parts can be reduced.
  • the puncture rod is moved in a first direction and a direction opposite to the first direction with respect to the housing.
  • Biasing means slidably disposed in a second direction and biasing the puncture rod in the first direction; and a first position with respect to the housing in the first direction. Moving the puncture rod in the second direction against the force of the urging means, and holding the puncture rod at a second position relative to the housing from the first position in the second direction.
  • Latching means a button which is pressed in a direction intersecting the first direction to act on the latching means to release the holding of the puncture rod, and a button which is in a third position with respect to the housing. Between the button and the latch means. A fourth pressing member which is located in the second direction from the third position with respect to the housing, by pressing the button against the latch means by contacting the button. When moved to the position, the press receiving part moves in the second direction from between the button and the latch means, and a button regulating means for allowing the button to act on the latch means; A sliding prevention means for preventing sliding between the button and the button regulating means.
  • microneedle applicator of this aspect even if the user tries to move the button restricting means in the second direction while pressing the button, sliding between the button and the button restricting means is prevented. In addition, smooth operation can be performed while ensuring safety.
  • a seventeenth aspect is the microneedle applicator according to the sixteenth aspect, wherein the slide prevention means is configured to press the fourth position from the third position of the button restricting means in a state pressed by the button. It has a movement restricting means for restricting the movement to the position.
  • the movement of the button restricting means from the third position to the fourth position is restricted, so that the sliding between the button and the button restricting means is prevented. Is prevented.
  • An eighteenth aspect is the microneedle applicator according to the seventeenth aspect, wherein the movement restricting means is in contact with the button restricting means moving in the second direction when pressed by the button.
  • the button restricting means has a contact surface for restricting the movement of the button restricting means to the fourth position.
  • the portion that comes into contact with the button regulating means and regulates the movement to the fourth position is formed in a planar shape, the movement of the button regulating means to the fourth position is achieved. Can be more reliably regulated.
  • a nineteenth aspect is the microneedle applicator according to the eighteenth aspect, wherein the contact surface is a stepped surface provided on a wall disposed on a side opposite to the button with respect to the button regulating means. It is something that is.
  • the button restricting means comes into contact with the step surface provided on the opposite wall, and the movement of the button restricting means to the fourth position is restricted. Is done. Thereby, sliding between the button and the button restricting means can be prevented.
  • a twentieth aspect is the microneedle applicator according to the sixteenth aspect, wherein the slide prevention means covers the pressing portion of the button when the button regulating means is at the third position,
  • the cover is a cover that exposes the pressing portion of the button when the button restricting means is at the fourth position.
  • the button cannot be pressed by the user until the button restricting means moves to the fourth position and the button is exposed from the cover. Is prevented from sliding.
  • a microneedle applicator as described in Japanese Patent Application Publication No. 2016-511105 includes, for example, a housing and a biasing unit housed in the housing, and is attached to the applicator by the biasing unit.
  • the microneedles protrude from the housing and are punctured into the patient's skin. That is, in such a microneedle applicator, for example, the urging means such as a compression coil spring is restored and deformed, and the microneedle is only punctured instantaneously. In some cases, administration was not sufficient. Therefore, there is a need for a microneedle applicator that can more reliably transdermally administer a drug.
  • Japanese Patent Publication No. 2016-511105 discloses that, for the purpose of improving penetration, an additional plunger element is continuously impacted on the first plunger element (microneedle) by using a plurality of springs. A collision mode has been proposed. However, when such a structure is adopted, a shocking external force is applied to the microneedles, so that the patient may feel discomfort such as pain.
  • a first aspect of the present invention which is different from the present invention made to solve such a problem, is a microneedle applicator in which a microneedle is projected from a housing by an urging means.
  • a shock-absorbing external force applying mechanism for continuously applying an external force applied in the protruding direction to the protruding microneedle via a buffer means.
  • the microneedle applicator of the present aspect since an additional external force is continuously applied to the microneedle protruding from the housing and piercing the skin, the piercing state of the microneedle to the skin is maintained. The stabilization of transdermal administration of the drug can be achieved. Further, since an additional external force is applied to the punctured microneedle via the buffer means, the effect of the impact force on the microneedle is reduced, and the patient's discomfort such as pain can be reduced.
  • the piston (14) pushed into the main body (12) against the impact spring (20) includes the catch (26) and the flexible finger. Engagement with the latch (30) of (28) locks in place.
  • a patch holder (34) holding a patch (44) having a plurality of microneedles is attached to the end of the main body (12).
  • Japanese Patent Application Laid-Open No. 2004-510530 discloses a rotation in which the cap (16) is rotated around an axis so that the pin (46) and the flexible finger (28) can take a position where they are aligned in the circumferential direction and a position where they are not aligned. The provision of a locking device is described. As described above, if the cap (16) is rotated at a position where the pin (46) and the flexible finger (28) do not align with each other, even if a force in the pressing direction acts on the cap (16) by mistake, the piston ( 14) is not released, and the security is high.
  • the present applicant has studied a button restricting means that is provided on a side surface of the main body and that can be moved in the puncture direction, in order to further improve safety.
  • a button restricting means it is conceivable that, when the button restricting means is not depressed, the button and the button restricting means interfere with each other to prevent the operation of the button. Then, the button can be operated by pushing the button restricting means to a predetermined position.
  • the pressed button and the button restricting means slide, whereby the respective members are worn or deformed, which hinders the smooth operation of the microneedle applicator. There was a possibility.
  • a housing is slidable in a first direction and a second direction opposite to the first direction.
  • a rod, a biasing unit for biasing the rod in a first direction, and the rod biased by the biasing unit are disposed in the first direction with respect to the rod.
  • a microneedle applicator that collides against a microneedle support that supports microneedles, presses the microneedle support against a target site, and punctures the microneedle into the target site; From a first position located in a first direction, the rod is moved in the second direction against a force by the urging means, and the rod is moved from the first position with respect to the housing.
  • a latch means for holding the rod at a second position located in the second direction, a button which is pressed in a direction intersecting with the first direction to act on the latch means to release the holding of the rod;
  • a press receiving portion for restricting the action of the button on the latch means by contacting the pressed button between the button and the latch means when the button is at the third position with respect to the housing;
  • the housing is moved from the third position to a fourth position located in the second direction with respect to the housing, the pressure receiving portion is moved from the button and the latch means to the second position.
  • a button restricting means for moving in the direction of the button to allow the button to act on the latching means, and a sliding preventing means for preventing sliding of the button and the button restricting means. That.
  • the movement of the movable cylinder toward the housing is controlled, which is effective in preventing an unintended puncture operation of the microneedle.
  • FIG. 2 is a vertical sectional perspective view of the microneedle applicator shown in FIG. 1.
  • FIG. 2 is an exploded perspective view of the microneedle applicator shown in FIG. 1.
  • FIG. 2 is a perspective view showing a state where a puncture rod is pushed in the microneedle applicator shown in FIG. 1.
  • FIG. 6 is a vertical sectional perspective view of the microneedle applicator shown in FIG. 5.
  • FIG. 6 is an exemplary perspective view showing a state in which a case for holding the microneedle is being mounted on the microneedle applicator shown in FIG. 5;
  • FIG. 8 is a perspective view showing a state in which a case holding the microneedle is attached to the microneedle applicator shown in FIG. 7.
  • FIG. 9 is a perspective view showing a state where a case cover is removed from a case holding the microneedle in the microneedle applicator shown in FIG. 8. The perspective view which shows the microneedle applicator shown in FIG. 9 from a plane side.
  • FIG. 11 is a cross-sectional perspective view showing a XI-XI cross section in FIG. 10.
  • FIG. 11 is a perspective view showing a state where a movable cylinder is moved to a housing side in the microneedle applicator shown in FIG. 10.
  • FIG. 13 is a perspective view in vertical section of the microneedle applicator shown in FIG. 12.
  • FIG. 13 is a longitudinal sectional view of the microneedle applicator shown in FIG. 12.
  • FIG. 15 is a cross-sectional perspective view showing a XV-XV cross section in FIG. 14.
  • FIG. 13 is a vertical cross-sectional view showing a state in which the puncture button is pressed and released in the microneedle applicator shown in FIG. 12 to puncture the microneedle and then the puncture button is released.
  • FIG. 13 is a perspective view showing a state where a movable cylinder is moved to a housing side in the microneedle applicator shown in FIG. 10.
  • FIG. 13 is a perspective view in vertical section of the microneedle applicator shown in FIG. 12.
  • FIG. 7 is a longitudinal sectional view showing a microneedle applicator as a second embodiment of the present invention in a storage state with a cover.
  • FIG. 18 is a perspective view showing a cap constituting the microneedle applicator shown in FIG. 17.
  • FIG. 11 is a longitudinal sectional view showing a microneedle applicator as a third embodiment of the present invention in a storage state before use.
  • FIG. 20 is an exploded perspective view of the microneedle applicator shown in FIG. 19.
  • FIG. 20 is an enlarged longitudinal sectional perspective view showing a main part of the microneedle applicator shown in FIG. 19, and is an explanatory diagram for explaining a movement restricting means for preventing a movable cylinder from moving to a housing side.
  • FIG. 20 is a perspective view showing the initial state before use in which the cap and the cover are removed from the housing from the microneedle applicator shown in FIG. 19 from the bottom side.
  • FIG. 23 is a perspective view showing a state where the puncture rod is pushed into the housing in the microneedle applicator shown in FIG. 22.
  • FIG. 24 is an exemplary perspective view showing a state where the case for holding the microneedle is being mounted on the microneedle applicator shown in FIG. 23;
  • FIG. 25 is an exemplary perspective view showing a state where a case for holding the microneedle is attached to the microneedle applicator shown in FIG. 24;
  • FIG. 26 is a perspective view showing a state where a case cover is removed from a case holding the microneedles in the microneedle applicator shown in FIG. 25.
  • FIG. 27 is a perspective view showing the microneedle applicator shown in FIG. 26 as viewed from the top.
  • FIG. 28 is a cross-sectional perspective view showing a XXVIII-XXVIII cross section in FIG. 27.
  • FIG. 28 is a perspective view showing a state in which the movable cylinder is pushed into the housing in the microneedle applicator shown in FIG. 27.
  • FIG. 30 is a longitudinal sectional view of the microneedle applicator shown in FIG. 29.
  • FIG. 31 is a cross-sectional perspective view showing a section XXXI-XXXI in FIG. 30.
  • FIG. 20 is a longitudinal sectional perspective view showing the microneedle applicator shown in FIG. 19 in a state where the microneedle is punctured.
  • FIG. 33 is a longitudinal sectional view of the microneedle applicator shown in FIG. 32.
  • FIG. 33 is a diagram illustrating a perspective view of the microneedle applicator illustrated in FIG. 32 except for an outer housing, and is an explanatory diagram illustrating a movement lock mechanism that prevents movement of a pressing force transmission member.
  • FIG. 20 is a longitudinal sectional view showing a state in which an additional external force is applied to the microneedle after puncturing in the microneedle applicator shown in FIG. 19. It is a perspective view showing a microneedle applicator as a 4th embodiment of the present invention, and a figure showing a puncture preparation state of a microneedle.
  • FIG. 37 is a perspective view of the microneedle applicator shown in FIG. 36 excluding the outer housing and the cylinder lock, and is an explanatory diagram for describing an operation lock mechanism that prevents operation of an additional external force operation member.
  • FIG. 37 is an exploded perspective view of the microneedle shown in FIG. 36.
  • FIG. 37 is a longitudinal cross-sectional perspective view of the microneedle shown in FIG.
  • FIG. 40 is a longitudinal sectional view of the microneedle shown in FIG. 39.
  • FIG. 37 is a longitudinal sectional view showing a state in which an additional external force is applied to the microneedle after puncturing in the microneedle applicator shown in FIG. 36.
  • FIG. 13 is a longitudinal sectional view showing a microneedle applicator as a fifth embodiment of the present invention in a storage state before use.
  • FIG. 43 is an exploded perspective view of the microneedle applicator shown in FIG. 42.
  • FIG. 43 is a longitudinal sectional view showing a state where the cap and the cover are removed from the microneedle applicator shown in FIG.
  • FIG. 43 is a longitudinal sectional view showing a puncture state of a microneedle in the microneedle applicator shown in FIG. 42.
  • FIG. 43 is a longitudinal sectional view showing a state in which an additional external force is applied to the microneedle in the microneedle applicator shown in FIG. 42.
  • FIG. 14 is an overall external perspective view of a microneedle applicator as a sixth embodiment of the present invention.
  • FIG. 48 is an exploded perspective view of the microneedle applicator shown in FIG. 47.
  • FIG. 48 is an explanatory diagram illustrating a state when the microneedle applicator illustrated in FIG. 47 is used.
  • FIG. 48 is a longitudinal sectional view showing a state when the microneedle applicator shown in FIG. 47 is used.
  • FIG. 48 is an external perspective view of a cylinder lock included in the microneedle applicator shown in FIG. 47.
  • FIG. 48 is an explanatory diagram illustrating a sliding prevention unit in the microneedle applicator shown in FIG. 47.
  • FIG. 19 is an overall perspective view of a microneedle applicator main body as a seventh embodiment of the present invention.
  • 53 (a) is a plan view showing the microneedle applicator shown in FIG. 53
  • FIG. 53 (b) is a sectional view taken along line BB in FIG. FIG.
  • FIG. 54 is an overall external perspective view showing a state in which a button is exposed by moving a cover in the microneedle applicator main body shown in FIG. 53;
  • FIG. 56 is a longitudinal sectional view of the microneedle applicator shown in FIG. 55.
  • FIGS. 1 and 2 show a microneedle applicator (hereinafter, applicator) 10 as a first embodiment of the present invention. 1 and 2, the applicator 10 is shown in an initial state in which a cover 152 described later is removed.
  • the applicator 10 is capable of holding a fine needle (microneedle 12 (see FIG. 9 and the like)), and presses the applicator 10 holding the microneedle 12 against the skin to hold the microneedle 12. By puncturing the skin, for example, a drug solution applied to the microneedle 12 is transcutaneously administered to the patient.
  • the up-down direction refers to a substantially up-down direction in FIG.
  • the upper side refers to a substantially upper side in FIG.
  • FIG. 1 shows a state in which FIG. 2 is turned upside down.
  • the applicator 10 includes a housing 16 having a generally bottomed cylindrical shape which is opened upside down and turned upside down.
  • the housing 16 includes an outer housing 18 located on the outer peripheral side and an inner housing 20 located on the inner peripheral side.
  • each member except the spring is preferably formed of a hard synthetic resin or the like.
  • the outer housing 18 has a generally inverted bottomed cylindrical shape that opens downward as a whole, and a peripheral wall portion 24 extends downward from the outer peripheral edge of the upper bottom wall portion 22.
  • the upper bottom wall portion 22 has a dome shape that is upwardly bulged in a substantially annular shape or a substantially annular regular octagon in plan view, and has a through hole 26 formed in the center thereof in a vertical direction. I have.
  • a substantially straight cylindrical peripheral wall portion 24 is integrally formed downward from the outer peripheral edge of the upper bottom wall portion 22.
  • a locking claw 28 is provided which protrudes downward.
  • the locking claw 28 is elastically deformable in a radial direction which is a direction perpendicular to the axis of the housing 16.
  • four locking claws 28 are formed at substantially equal intervals (approximately every 90 degrees) on the circumference.
  • two flat or curved plate-like supporting wall portions 30a protruding downward. 30b are formed so as to face each other in the radial direction (the left-right direction in FIG. 14 described later). That is, one support wall portion 30a is provided between a puncture button 102, which will be described later, and a member such as the puncture rod 14 or the puncture spring 70 provided at the center, and the other support wall portion 30b is connected to the puncture rod. 14 and the puncture spring 70 are provided on the opposite side.
  • a guide projection 32 protruding toward the outer peripheral side is formed at the center of the one support wall 30a in the width direction (circumferential direction) so as to extend in the vertical direction.
  • a notch 34 that opens downward is provided at the center in the width direction of the other support wall 30b.
  • a fitting hole 36 that penetrates the peripheral wall portion 24 in the thickness direction is formed at a vertically intermediate portion of the outer housing 18.
  • the inner housing 20 has a generally inverted, substantially bottomed cylindrical shape smaller than the outer housing 18 as a whole. That is, a lid 38 having substantially the same shape as the through hole 26 of the outer housing 18 is provided at an upper end portion of the inner housing 20. A locking hole 40 penetrating in the radial direction is provided below the lid 38 at a position corresponding to the locking claw 28 of the outer housing 18. Further, a substantially small-diameter cylindrical spring support portion 42 for supporting a puncture spring 70 described later is provided integrally on the inner surface of the lid portion 38 so as to protrude downward.
  • the peripheral wall portion extending downward from the outer periphery of the lid portion 38 is provided with a step at an intermediate portion in the height direction, and the lower part of the step is a large-diameter peripheral wall portion 44.
  • the peripheral wall portion 44 has a substantially rounded rectangular shape, and includes a wall portion 46a located inside the support wall portion 30a in the outer housing 18, a wall portion 46b located inside the support wall portion 30b, and And a pair of walls 46c, 46c interconnecting the opposing walls 46a, 46b.
  • the outer surface of the wall portion 46a is a vertical plane extending from the upper end to the lower end below the step, and a contact surface extending in a direction perpendicular to the axis is formed at the lower end of the vertical plane.
  • a guide groove 48 is formed substantially at the center of the inner surface of the wall portion 46a in the width direction and extends substantially the entire length in the vertical direction below the step and opens inward.
  • each of the wall portions 46a, 46b, 46c, 46c constituting the peripheral wall portion 44 has a locking hole 40 formed at a position above the step.
  • the wall portion 46b is provided with a notch 50 extending downward from the locking hole 40, and the wall portions 46c, 46c are provided with notches 52, 52 extending downward from the locking holes 40, 40. Is provided.
  • ribs extending partially in the vertical direction are provided on the outer surfaces of the walls 46b, 46c, 46c.
  • a collar portion 54 is formed at the lower end of the inner housing 20 so that the inner periphery is widened and protrudes downward.
  • the housing 16 is formed by inserting the inner housing 20 into the outer housing 18 from below and assembling the inner housing 20 from below.
  • the lid portion 38 of the inner housing 20 is fitted into the through hole 26 of the outer housing 18, and the locking claws 28 are locked in the locking holes 40.
  • the outer and inner housings 18 and 20 are positioned in the circumferential direction by making the inner and outer peripheral surfaces superposed radially non-circular.
  • the outer housing 18 and the inner housing 20 are fixed in a state where they are positioned in the vertical direction. In this fixed state, the upper end surface of the outer housing 18 (the upper end surface of the upper bottom wall portion 22) and the upper end surface of the inner housing 20 (the upper end surface of the lid portion 38) are substantially at the same position in the vertical direction. I have.
  • the puncture rod 14 is disposed inside the housing 16.
  • the puncture rod 14 has a tubular portion 56 and a bottom wall portion 58, and has a substantially bottomed tubular shape that extends vertically as a whole.
  • the outer peripheral shape of the cylindrical portion 56 is slightly smaller than the inner peripheral shape of the peripheral wall portion 44 of the inner housing 20.
  • the cylindrical portion 56 has walls 60a, 60b, 60c, 60c at respective wall portions corresponding to the walls 46a, 46b, 46c, 46c of the inner housing 20, respectively.
  • a guide ridge 62 extending substantially over the entire length in the up-down direction is protruded outward at substantially the center of the wall portion 60a in the width direction.
  • a through window 64 is formed in the upper part of the wall 60b so as to penetrate the wall 60b.
  • a positioning protrusion 66 protruding outward is provided at an upper end portion of the wall portion 60c.
  • the bottom wall portion 58 is formed in a substantially disk shape having an outer diameter larger than the cylindrical portion 56, and protrudes in a flange shape at the lower end of the puncture rod 14.
  • a substantially cylindrical spring supporting portion 68 is provided on the upper surface of the bottom wall portion 58 and projects into the cylindrical portion 56 and supports a lower end of a puncture spring 70 described later.
  • the puncture rod 14 as described above is inserted from below into the peripheral wall portion 44 of the inner housing 20 in the tubular portion 56.
  • a guide ridge 62 provided on the outer surface of the wall portion 60a of the cylindrical portion 56 is inserted into a guide groove 48 provided on the inner surface of the wall portion 46a of the peripheral wall portion 44, and provided on the wall portion 46c.
  • a positioning projection 66 provided on the wall 60c is inserted into the cutout 52 thus formed.
  • the moving end of the puncture rod 14 upward with respect to the inner housing 20 can be defined, for example, by the outer peripheral portion of the bottom wall portion 58 hitting the lower end portion of the peripheral wall portion 44. Further, the moving end of the puncture rod 14 downward with respect to the inner housing 20 can be defined by the positioning protrusion 66 hitting the lower end of the notch 52 or the like.
  • a compression coil spring serving as a puncture spring 70 is housed in the tubular portion 56 of the puncture rod 14 so that a biasing force can be exerted between the lid portion 38 and the bottom wall portion 58 that face each other in the axial direction. It has become.
  • a movable cylinder 72 having a substantially cylindrical shape as a whole is assembled to the housing 16 so as to be movable in the vertical direction.
  • the peripheral wall portion 74 has a substantially octagonal shape.
  • an inlet 76 is provided on a part (left side in FIG. 14) on the periphery of the peripheral wall portion 74.
  • the entrance 76 has a cutout window shape opened downward. As described later, the user can easily insert his / her fingers into the movable cylinder 72 from the outside of the movable cylinder 72 through the entrance 76.
  • a part of the peripheral wall portion 74 on the periphery (left side in FIG. 14) is formed with a contact plate portion 78 projecting upward.
  • the contact plate portion 78 is provided with projecting contact portions 80, 80 projecting from both sides in the width direction (the circumferential direction of the peripheral wall portion 74).
  • Each projecting contact portion 80 extends downward from the upper end of the contact plate portion 78 by a predetermined length, and the lower end of the projecting contact portion 80 is an inclined surface 81.
  • the projecting contact portion 80 is not provided, and a notch-like contact avoidance region 82 is formed.
  • a guide recess 84 is formed substantially at the center of the inner surface of the contact plate portion 78 in the width direction and extends over substantially the entire length in the vertical direction.
  • a substantially cylindrical spring accommodating portion 86 that opens upward is formed on the peripheral wall portion 74.
  • a pair of spring accommodating portions 86, 86 are provided so as to be opposed to each other in a direction perpendicular to the axis of the peripheral wall portion 74 (a direction in front of the paper surface in FIG. 14).
  • the spring housing 86 protrudes above the peripheral wall 74 of the movable cylinder 72.
  • pressing portions 88 are protruded from inner surfaces of the pair of spring housing portions 86 facing each other.
  • a front surface on the side of the puncture button 102 which will be described later, has an inclined surface 90 (see FIG. 15) inclined rearward (to the right in FIG. 14) away from the puncture button 102 as it goes downward. Have been.
  • the movable cylinder 72 is provided with a pair of case holding portions 92, 92 for holding a case 160 of the microneedle 12, which will be described later, protruding below the pair of spring housing portions 86, 86.
  • Each case holding portion 92 has a substantially rectangular frame shape, and a claw portion 94 protruding inward is provided substantially at the center of the lower side portion.
  • the inner surface of the claw portion 94 is provided with unevenness, and can be engaged with the unevenness provided on the outer circumferential surface of the case 160 of the microneedle 12 as described later.
  • a stopper 96 that protrudes downward is provided on the rear side of the peripheral wall 74 of the movable cylinder 72 that faces the inlet 76 in the radial direction.
  • the stopper 96 defines a moving end for pushing the case 160 rearward when the case 160 of the microneedle 12 described later is mounted on the movable cylinder 72.
  • the peripheral wall 74 of the movable cylinder 72 is located between the peripheral wall 24 of the outer housing 18 and the peripheral wall 44 of the inner housing 20.
  • the guide projections 32 of the support wall 30a of the outer housing 18 are inserted into guide recesses 84 provided on the contact plate 78 of the movable cylinder 72, and guides between the guide projections 32 and the guide recesses 84.
  • the movable cylinder 72 is movable with respect to the housing 16 without tilting in the vertical direction.
  • each presser spring 98 is positioned by a spring holding portion 100 (see FIG. 11) protruding from the inner surface of the upper bottom wall 22 of the outer housing 18.
  • a puncture button 102 for performing a puncture operation of the microneedle 12 and a lock lever 104 are assembled to the housing 16.
  • the puncture button 102 is fitted into the fitting hole 36 so as to be able to move in and out, and protrudes out of the outer housing 18, and a flange portion which spreads inside the fitting hole 36 to prevent the puncture button 102 from coming out of the outer housing 18. 108.
  • engaging protrusions 110, 110 protruding inward are provided at both end portions in the width direction of the flange portion 108 (forward and backward in FIG. 14).
  • An inclined surface 112 (see FIG. 3) whose projection height gradually increases downward is provided on the projecting distal end surface of each engagement projection 110.
  • the lock lever 104 is a substantially rectangular frame-shaped member as a whole, and the peripheral wall portion 114 has substantially flat plate-shaped walls 116a and 116b opposed in the front-rear direction and left-right direction. It is composed of walls 116c, 116c.
  • the notch-shaped through-grooves 118, 118 that open upward are provided on the front wall 116 a of the peripheral wall 114 at positions corresponding to the engagement protrusions 110, 110 of the puncture button 102. Then, the flange portion 108 of the puncture button 102 is superimposed on the wall portion 116a from the outside, and the engagement protrusion 110 is inserted into the through groove 118 and protrudes inward of the lock lever 104.
  • the rear wall portion 116b of the peripheral wall portion 114 is provided with a spring support portion 120 protruding outward from substantially the center in the circumferential direction and a locking portion 122 protruding inward.
  • the lower surface of the protruding tip of the locking portion 122 is an inclined surface whose inward protruding height increases as it goes upward.
  • the inclined curved surface 124 is curved and inclined. ing.
  • the upper surface of the locking portion 122 is a flat surface 125 that spreads substantially horizontally.
  • each of the left and right side wall portions 116c, 116c of the peripheral wall portion 114 is provided with an opening groove 126 which opens outward and extends over substantially the entire length in the vertical direction.
  • an inclined surface 128 (see FIG. 3) that is inclined in a direction of decreasing the groove width as it goes downward is provided on the inner surface of the groove on the front side of the opening groove 126.
  • a cylinder lock 130 is disposed as a lock member for preventing the movable cylinder 72 from moving upward.
  • the cylinder lock 130 is a substantially rectangular frame-shaped member as a whole, and a peripheral wall portion 132 has a pair of wall portions 134c which are opposed to each other in a front-rear direction and substantially flat plate-shaped wall portions 134a and 134b. , 134c.
  • the rear wall portion 134b is provided with a spring support portion 136 protruding outward from a substantially center in the circumferential direction and an engaging portion 138 protruding inward.
  • the lower surface of the protruding tip of the engaging portion 138 is an inclined surface that inclines upward toward the protruding tip, and in the present embodiment, is an inclined curved surface 140 that inclines while curving.
  • each of the left and right walls 134c, 134c is provided with a contact protrusion 142 protruding downward.
  • a button spring 144 and a lock spring 146 are assembled between the outer housing 18 that houses them.
  • One end of the button spring 144 is externally inserted into the spring support portion 120 of the lock lever 104, and the other end is supported on the opposed inner surface of the outer housing 18.
  • one end of the lock spring 146 is externally inserted into the spring support portion 136 of the cylinder lock 130, and the other end is supported on the opposed inner surface of the outer housing 18.
  • the lock lever 104 and the cylinder lock 130 are biased toward the front of the outer housing 18, and the puncture button 102 located in front of the lock lever 104 projects from the fitting hole 36 of the outer housing 18. Is biased to the state.
  • a cylinder lock 130 is superimposed on the lock lever 104, and a wall 116b of the lock lever 104, a wall 134b of the cylinder lock 130, and a locking portion projecting inward from the walls 116b, 134b.
  • the lock lever 104 and the cylinder lock 130 can be moved in a direction intersecting with the pushing direction (vertical direction) of the puncture rod 14, and in the present embodiment, the front and rear directions are orthogonal to the pushing direction of the puncture rod 14. It is possible to move in the direction.
  • the lock lever 104 and the cylinder lock 130 may be movable in a direction inclined with respect to the front-rear direction.
  • the applicator 10 is shown in an initial state. That is, the puncture spring 70, the presser spring 98, the button spring 144, and the lock spring 146 provided inside the applicator 10 are all in a natural length or in a slightly initial compression state, and the puncture rod 14 and the movable cylinder All 72 project downward from the housing 16.
  • the bottom wall portion 58 of the puncture rod 14 is located inside the movable cylinder 72, but in the initial state, the puncture rod is located outside (below) the movable cylinder. It may protrude up to.
  • puncturing button 102 is in a state of protruding outward from fitting hole 36 of housing 16 (outer housing 18). Furthermore, in the initial state, the lock lever 104 and the cylinder lock 130 are provided with inclined curved surfaces 124 and 140 provided at the protruding tips of the locking portion 122 and the engaging portion 138 provided inside thereof, respectively.
  • the rod 14 is disposed at a position where the wall 60b of the cylindrical portion 56 overlaps with the wall 60b in the vertical projection.
  • the protruding abutting portions 80, 80 which are the upper ends of the abutting plate portions 78 of the movable cylinder 72, and project downward from the wall portions 134 c, 134 c of the cylinder lock 130.
  • the contact projections 142, 142 contact each other in the up-down direction.
  • the movement restricting means 148 for preventing the movement of the movable cylinder 72 toward the housing 16 is controlled by the movable cylinder 72.
  • a contact protrusion 142 of the cylinder lock 130 is controlled by the movable cylinder 72.
  • the engagement protrusion 110 protruding inward from the puncture button 102 is inserted into the peripheral wall portion through the through groove 118 provided in the wall portion 116a of the lock lever 104.
  • the protrusion of the engagement protrusion 110 extends in the front-rear direction with respect to the protrusion contact portion 80 of the contact plate portion 78 of the movable cylinder 72 provided inside the wall portion 116a. It comes into contact.
  • the pressing operation of the puncture button 102 is disabled, and in the present embodiment, the safety mechanism 150 that disables the puncture button 102 is movable with the engaging projection 110 of the puncture button 102. And a projecting contact portion 80 of the cylinder 72.
  • the cover 152 has a substantially cup shape as a whole, and includes a bottom wall portion 154 and a peripheral wall portion 156 each having a substantially octagonal shape.
  • the peripheral wall portion 156 is detachably fitted to the peripheral wall portion 24 of the housing 16 (outer housing 18), so that the cover 152 covers the movable cylinder 72 and the puncture rod 14 from outside, and the movable cylinder 72 and the puncture rod.
  • the rod 14 can be protected from external force.
  • the puncture rod 14 When using the applicator 10, first, the puncture rod 14 is pushed into the housing 16 from the initial state, as shown in FIGS. That is, by pressing the bottom wall portion 58 of the puncture rod 14 with a finger inserted from the insertion port 76 of the movable cylinder 72, the puncture rod 14 is pushed above the housing 16 while compressing and deforming the puncture spring 70. As shown in FIG. 5, the applicator 10 may be gripped in an upside down state and operated to push down the puncture rod 14. When the puncture rod 14 is pushed into the housing 16, the guide action between the guide ridge 62 of the puncture rod 14 and the guide groove 48 of the inner housing 20 and the positioning protrusion 66 of the puncture rod 14 are notched in the inner housing 20. The puncture rod 14 is pushed into the housing 16 without inclining due to the guide action by fitting into the 52.
  • the puncture rod 14 moves upward, and the inclination curve of the locking portion 122 protruding inward from the upper end of the wall portion 60 b of the puncture rod 14 and the lock lever 104.
  • the surface 124 abuts.
  • the release means 158 that releases the movement restriction means 148 and allows the movable cylinder 72 to move toward the housing 16 moves the protruding contact portion 80 and the contact protrusion 142 in a non-contact state.
  • the mechanism is configured as follows. Therefore, in the present embodiment, the movement of the movable cylinder 72 is prevented by the contact between the movable cylinder 72 and the cylinder lock 130, and the movement of the movable cylinder 72 is allowed by the release of the contact between the movable cylinder 72 and the cylinder lock 130. The movement of the lock 130 is selectively realized.
  • the movement restricting means 148 for preventing the movement of the movable cylinder 72 is configured to include the cover 152. Can also. Further, since the puncture rod 14 can be pushed in and the movable cylinder 72 can be moved by removing the cover 152, it is understood that the release means 158 that allows the movement of the movable cylinder 72 is constituted by a structure for removing the cover 152. You can also.
  • the cover that constitutes the movement restricting means is not limited to the one that is released by being detached.
  • a moving means that allows the movable cylinder 72 to move can be configured by moving, opening, or tilting.
  • the locking portion 122 of the lock lever 104 enters the penetrating window 64, and the lock lever 104 is moved. Moves forward based on the elastic restoring force of the button spring 144. As a result, the flat surface 125 at the protruding tip end of the locking portion 122 comes into contact with the inner surface of the through window 64, and the locking portion 122 is locked to the through window 64. As a result, the downward movement of the puncture rod 14 is prevented, and the puncture rod 14 is pushed into the housing 16 and is held in a state where the downward biasing force of the puncture spring 70 is exerted.
  • the case 160 holding the microneedle 12 is attached to the movable cylinder 72 of the applicator 10 as shown in FIGS.
  • the case 160 includes a case main body 162 that holds the microneedle 12 and a case cover 164 that covers the case main body 162 from the outside.
  • the case main body 162 of the present embodiment has a substantially annular shape as a whole, and an outer peripheral flange portion 168 and an inner peripheral flange portion 170 (see FIG. 13) are formed at the upper end of the cylindrical wall portion 166.
  • the outer diameter of the cylindrical wall 166 is substantially equal to the distance between the case holding portions 92 and 92 in the movable cylinder 72, and the inner diameter of the inner peripheral flange 170 of the cylindrical wall 166 is punctured.
  • the outer diameter of the bottom wall 58 of the rod 14 is larger than that of the rod 14.
  • the outer peripheral portion of the substantially circular pressure-sensitive adhesive sheet 172 is overlapped and fixed to the inner peripheral flange portion 170.
  • the microneedles 12 are fixed at the central portion, and are arranged in the center hole of the inner peripheral flange portion 170.
  • the microneedle 12 includes a needle main body 174 including a plurality of minute solid needles and a base 176 to which the needle main body 174 is fixed.
  • the medicine to be administered to the patient is applied to the needle body 174.
  • the case cover 164 has a substantially U-shape as a whole, and includes a pair of cover portions 178, 178 which cover the case body 162 from both upper and lower sides, and partially cover these cover portions 178, 178 on the periphery. And a connection unit 180 for connecting the terminals with each other.
  • the case cover 164 is detachable from the case body 162 toward the side.
  • the case 160 can be attached to and detached from the movable cylinder 72 through the insertion port 76 with the case cover 164 attached to the case main body 162.
  • the outer peripheral flange portion 168 is sandwiched between the claw portion 94 of the case holding portion 92 and the peripheral wall portion 74 in the vertical direction, and the outer peripheral surface of the cylindrical wall portion 166. And the unevenness provided on the claw portion 94 are engaged with each other.
  • the applicator 10 with the case 160 provided with the microneedles 12 is pressed against the patient's skin at the lower surface of FIGS. That is, the housing 16 is pushed downward with the lower end of the cylindrical wall portion 166 of the case main body 162 in contact with the patient's skin, and the housing 16 and the case main body 162 are displaced toward each other.
  • the movable cylinder 72 is moved toward the housing 16 (upward). That is, by moving the movable cylinder 72 toward the housing 16, substantially the entire peripheral wall 74 of the movable cylinder 72 is housed in the housing 16 while the pressing spring 98 is compressed and deformed.
  • the movable cylinder 72 is moved into the housing 16 by the guide action of the guide projection 32 of the housing 16 and the guide recess 84 of the movable cylinder 72, so that the movable cylinder 72 is moved straight up and down with respect to the housing 16.
  • the safety mechanism 150 is configured by the engagement protrusion 110 of the puncture button 102 and the protrusion contact portion 80 of the movable cylinder 72 contacting each other. Is not possible, but the movable cylinder 72 moves upward in the housing 16 (moves toward the housing 16), thereby releasing the contact between the engagement protrusion 110 and the protrusion contact portion 80. Then, the engagement protrusion 110 is moved to the contact avoidance area 82 located below the projecting contact part 80. Thereby, the safety mechanism 150 is released, and the puncture button 102 can be pushed in through the fitting hole 36 of the housing 16.
  • the pressing portion 88 provided on the spring housing portion 86 of the movable cylinder 72 enters the opening groove 126 provided on the wall portion 116 c of the lock lever 104.
  • the inclined surface 90 provided in the pressing portion 88 and the inclined surface 128 provided in the opening groove 126 face each other in a state of being separated from each other in the front-back direction.
  • FIG. 16 shows a state in which the pressing of the puncture button 102 is released after the microneedle 12 has been punctured. That is, the puncture button 102 and the lock lever 104 located inside the puncture button 102 are moved rearward with the compression deformation of the button spring 144 from the state shown in FIGS. The locking of the locking portion 122 by the lock 64 is released, and the puncture rod 14 is moved downward based on the elastic restoring force of the puncture spring 70.
  • the inclined surface 90 of the pressing portion 88 of the movable cylinder 72 and the inclined surface 128 of the opening groove 126 of the lock lever 104 are mutually moved by the movement of the lock lever 104 accompanying the pushing operation of the puncture button 102. It comes into contact.
  • the movable cylinder 72 and the lock lever 104 described later can be stably moved to the initial positions.
  • the lower end portion of the puncture rod 14 passes through the inside of the case main body 162, and the bottom wall portion 58 of the puncture rod 14 presses the microneedles 12 together with the adhesive sheet 172 against the skin. That is, the microneedles 12 are attached to the skin with the adhesive sheet 172 in a state where the microneedles 12 are punctured into the skin, and the microneedles 12 are pressed and punctured against the skin for a predetermined time. Thereby, the medicine applied to the microneedle 12 can be effectively administered to the patient.
  • the lock lever 104 When the puncture button 102 is released from the puncture operation state, the lock lever 104 is returned to the initial position by the elastic restoring force of the button spring 144, as shown in FIG. Further, since the contact between the wall portion 60b of the puncture rod 14 and the engaging portion 138 of the cylinder lock 130 is released, the cylinder lock 130 is returned to the initial position by the elastic restoring force of the lock spring 146. It has become. Further, by moving the applicator 10 away from the skin from the state shown in FIG. 16, the movable cylinder 72 is returned to the initial position by the elastic restoring force of the pressing spring 98. Thereby, since the applicator 10 returns to the initial state shown in FIGS. 1 and 2, the applicator 10 can be used a plurality of times by detaching and replacing the case 160.
  • the movement restricting means 148 for moving the movable cylinder 72 toward the housing 16 is provided, and the movement restricting means 148 is moved to the housing 16 of the puncture rod 14. Is depressed by pushing. That is, before the puncture rod 14 is pushed, the microneedle 12 is attached to the movable cylinder 72, and even when the applicator 10 is pressed against the skin in this state, the movable cylinder 72 moves into the housing 16 and the microneedle 12 moves. An erroneous puncture in which the puncture 12 punctures the skin is prevented.
  • the movement restricting means 148 that prevents the movement of the movable cylinder 72 is configured by the projecting contact portion 80 of the movable cylinder 72 and the contact projection 142 of the cylinder lock 130 abutting each other.
  • the puncture rod 14 and moving the cylinder lock 130 by pushing the puncture rod 14 and moving the cylinder lock 130, the contact between the projecting contact portion 80 and the contact projection 142 is released, and the movement of the movable cylinder 72 is allowed. ing. That is, before and after the movement of the cylinder lock 130, prevention and allowance of the movement of the movable cylinder 72 are selectively realized.
  • the structure is simplified and the number of parts is reduced.
  • the safety mechanism 150 that prevents the pushing operation of the puncture button 102 before the movement of the movable cylinder 72 is configured, for example, before the applicator 10 is pressed against the skin, the microneedle 12 The possibility that the microneedle 12 protruding from the microneedle 12 is unintentionally punctured into the skin is prevented.
  • the safety mechanism 150 since the safety mechanism 150 includes the protruding abutting portion 80 of the movable cylinder 72, the protruding abutting portion 80 can constitute both the movement restricting means 148 and the safety mechanism 150, Further simplification of the structure and reduction of the number of parts can be achieved.
  • FIG. 17 shows a microneedle applicator 190 as a second embodiment of the present invention.
  • the movement restricting means for preventing the movement of the movable cylinder 72 is realized in a mode different from that of the first embodiment.
  • FIG. 17 shows the applicator 190 in a storage state before use.
  • members and portions substantially the same as those in the first embodiment are denoted by the same reference numerals in the drawings as those in the first embodiment, and detailed description thereof will be omitted.
  • the cap 192 is provided to prevent the puncture rod 14 from being pushed into the housing 16 before the puncture rod 14 projects into the movable cylinder 72 before use.
  • the cap 192 has a cup shape having a bottom wall portion 194 and a substantially cylindrical peripheral wall portion 196.
  • a flange 198 that protrudes to the outer periphery is provided on the peripheral edge of the opening of the peripheral wall 196.
  • the outer diameter of the flange 198 is substantially equal to the inner diameter of the peripheral wall 74 of the movable cylinder 72, and the flange 198 is inserted from the lower opening of the movable cylinder 72 with the opening of the cap 192 facing upward.
  • the flange 198 of the cap 192 is substantially fitted into the peripheral wall 74 of the movable cylinder 72, and the cap 192 is removably assembled to the movable cylinder 72.
  • the bottom wall portion 194 of the cap 192 is located below the case holding portion 92 of the movable cylinder 72, and the applicator 190 is placed on the skin.
  • the movable cylinder 72 is prevented from being pushed up by the skin and moved to the housing 16 side.
  • the bottom wall portion 194 of the cap 192 is located below the case holding portion 92 of the movable cylinder 72. 160) cannot be mounted on the movable cylinder 72.
  • the movable cylinder 72 does not move toward the housing 16 unless the cap 192 is removed. Therefore, in the present embodiment, a movement that prevents the movable cylinder 72 from moving toward the housing 16 by the cap 192. Limiting means 200 is configured. Also in this embodiment, since the same cylinder lock 130 as that of the above embodiment is employed, the movable cylinder 72 is prevented from moving toward the housing 16 until the puncture rod 14 is pushed into the housing 16. I have. That is, since the movement of the movable cylinder 72 toward the housing 16 is allowed with the pushing operation of the puncture rod 14, the same effect as in the first embodiment can be exerted.
  • the movement restricting means 200 is released after the cap 192 is removed after the cap 192 is removed.
  • This is realized by a pushing operation of the puncture rod 14 similar to the above. That is, in this embodiment, since the pushing operation of the puncture rod 14 can be performed by removing the cap 192, the releasing means (158) of the movement restricting means 200 similar to the first embodiment is provided with the cap 192. Is constituted by the removal structure.
  • the movement restriction unit 200 is configured to include the cover 152 and the release unit (158). ) Can be understood to be constituted by the structure for removing the cover 152.
  • the case (160) of the microneedle (12) cannot be attached until the cap 192 is removed. Therefore, before removing the cap 192, the microneedle (12) is erroneously punctured in the first place. No problem occurs, and even if the cap 192 is removed, the movable cylinder 72 is prevented from moving toward the housing 16 before the puncture rod 14 is pushed, so that the microneedle (12) is erroneously punctured. Can be effectively prevented.
  • FIG. 19 shows a microneedle applicator (hereinafter, applicator) 210 as a third embodiment of the present invention.
  • the applicator 210 is shown in a state before use, for example, in a storage state where the applicator 210 is distributed as a product on the market and provided to the user.
  • the applicator 210 includes a housing 212 and a puncture spring 214 as an urging means housed in the housing 212.
  • the microneedle 216 (see FIG. 26 and the like) is operated by the urging force of the puncture spring 214. Can be projected from the housing 212 to puncture the skin. Thereby, the medicine applied to the microneedle 216 is transdermally administered to the patient.
  • the up-down direction refers to the up-down direction in FIG. 19 that is the moving direction of the puncture rod 218 due to the deformation of the puncture spring 214 described later.
  • “upper” refers to the upper side in FIG. 19, which is the side (far side from the skin) that the user grips and presses when the applicator 210 is pressed against the patient's skin, while “lower” refers to the patient's skin. 19 is the lower side in FIG.
  • the front refers to the left side in FIG. 19 in which a puncturing button 322 and a pressing button 372, which will be described later, protrude from the housing 212
  • the rear refers to the pushing of the puncturing button 322 and the pressing button 372
  • the applicator 210 is provided with a housing 212 having a substantially bottomed cylindrical shape that is open upward and turned upside down as a whole.
  • the housing 212 includes an outer housing 220 located on the outer peripheral side and an inner housing 222 located on the inner peripheral side.
  • each member except the spring is formed of a hard synthetic resin or the like.
  • the outer housing 220 has a substantially inverted bottomed cylindrical shape that opens downward as a whole, and a peripheral wall portion 226 extends downward from the outer peripheral edge of the upper bottom wall portion 224.
  • the upper bottom wall portion 224 has a substantially annular shape or a substantially annular regular octagon in plan view, and has a dome shape bulging upward, and has a substantially regular octagonal shape penetrating vertically in the center.
  • a through hole 228 is formed. Further, in the upper bottom wall portion 224, on the outer peripheral side of the through hole 228, a substantially rectangular window portion 229 (FIG. 29, etc.) penetrating in a vertical direction at a part of the periphery (the depth of the paper in FIG. 19). Reference) is formed.
  • a substantially straight cylindrical peripheral wall portion 226 is integrally formed downward from the outer peripheral edge of the upper bottom wall portion 224.
  • a locking claw 230 projecting downward is provided on the periphery of the opening of the through hole 228 of the upper bottom wall portion 224.
  • the locking claw 230 is elastically deformable in a radial direction (the left-right direction in FIG. 19) which is a direction perpendicular to the axis of the housing 212.
  • the four locking claws 230 are formed at substantially equal intervals (approximately every 90 degrees) on the circumference.
  • 232a and 232b are formed to face each other in the radial direction (the left-right direction in FIG. 19). That is, a support wall 232a is provided on one side with members such as a puncture spring 214 and a puncture rod 218 provided at the center of the applicator 210, and a support wall 232b is provided on the other side. I have. In this embodiment, the vertical dimension of one support wall 232a is larger than the vertical dimension of the other support wall 232b.
  • a guide protrusion 234 (see FIG. 21 or the like) projecting outward is formed at a central portion in the width direction (circumferential direction) of one support wall portion 232a so as to extend in the vertical direction.
  • a puncture button hole 236 and a pressure button hole 238 penetrating the upper bottom wall portion 224 and / or the peripheral wall portion 226 in the thickness direction are formed in a vertically intermediate portion of the outer housing 220.
  • the holes 236 and 238 each have a substantially horizontally long rectangular shape, and are arranged side by side in a part on the circumference (left side in FIG. 19) so as to be vertically separated from each other. I have.
  • the puncture button hole 236 has a size slightly larger than the pressure button hole 238 and is located below the pressure button hole 238.
  • the inner housing 222 has a substantially inverted bottomed cylindrical shape smaller than the outer housing 220 as a whole. That is, a lid portion 240 having substantially the same shape as the through hole 228 of the outer housing 220 is provided at the upper end portion of the inner housing 222. A locking hole 242 penetrating in the radial direction is provided below the lid 240 at a position corresponding to the locking claw 230 of the outer housing 220. Further, on the inner surface (lower surface) of the lid portion 240, a substantially columnar or polygonal column-shaped spring support portion 246 for supporting a pressure spring 288 as an additional external force generating member described later is integrally provided so as to protrude downward. ing. In the present embodiment, the lower end of the spring support portion 246 extends to the vertical intermediate portion of the housing 212 (the vertical intermediate portion of the peripheral wall portion 226 of the outer housing 220).
  • a step is provided at a middle portion in the height direction of the peripheral wall portion extending downward from the outer periphery of the lid portion 240, and a lower portion of the peripheral wall portion 248 is a large-diameter peripheral wall portion 248.
  • the peripheral wall portion 248 has a substantially rounded rectangular shape or a substantially regular octagonal shape, and includes a wall portion 250a located inside the support wall portion 232a of the outer housing 220 and a wall portion located inside the support wall portion 232b. It comprises a portion 250b and a pair of walls 250c, 250c interconnecting the radially opposed walls 250a, 250b.
  • the outer surface of the wall 250a is a vertical plane extending from the upper end to the lower end below the step, and a contact surface extending in a direction perpendicular to the axis is formed at the lower end of the vertical plane.
  • a guide groove 252 (see FIG. 28 and the like) is formed substantially at the center in the width direction on the inner surface of the wall portion 250a, extending substantially the entire length in the vertical direction below the step and opening inward.
  • the above-described locking holes 242 are formed in the respective wall portions 250a, 250b, 250c, 250c constituting the peripheral wall portion 248 at positions above the steps.
  • a notch 254 extending downward from the locking hole 242 is provided in the wall 250b, and notches 256 and 256 extending downward from the locking holes 242 and 242 are provided in the walls 250c and 250c. Is provided.
  • ribs that partially extend in the vertical direction are provided on the outer surfaces of the walls 250b, 250c, and 250c. Further, a collar portion 258 is formed at the lower end of the inner housing 222 so as to protrude downward with its inner periphery expanded.
  • the housing 212 is configured by inserting the above-described inner housing 222 from below into the above-described outer housing 220 and assembling the same.
  • the lid 240 of the inner housing 222 is fitted in the through hole 228 of the outer housing 220, and each locking claw 230 is locked in the locking hole 242.
  • Both the outer and inner housings 220 and 222 have a non-circular inner and outer peripheral surface (in the present embodiment, each having a substantially regular octagonal shape) superimposed radially in the through hole 228 and the lid 240. It is positioned in the circumferential direction. Further, the locking action of the locking claw 230 on the locking hole 242 and the contact between the lower end of the support wall portion 232 a of the outer housing 220 and the abutting surface formed at the lower end of the wall portion 250 a of the inner housing 222. By the action, the outer housing 220 and the inner housing 222 are fixed in a state where they are positioned in the vertical direction.
  • the upper end surface of the outer housing 220 (the upper end surface of the upper bottom wall portion 224) and the upper end surface of the inner housing 222 (the upper end surface of the lid portion 240) are substantially at the same position in the vertical direction. I have.
  • puncture rod 218 is arranged inside housing 212.
  • the puncture rod 218 has a cylindrical portion 260 and a bottom wall portion 262, and has a substantially bottomed cylindrical shape extending vertically as a whole.
  • the outer peripheral shape of the cylindrical portion 260 is slightly smaller than the inner peripheral shape of the peripheral wall portion 248 of the inner housing 222.
  • the cylindrical portion 260 includes walls 264a, 264b, 264c, and 264c as walls that radially oppose the walls 250a, 250b, 250c, and 250c on the inner peripheral side of the inner housing 222, respectively.
  • a guide ridge 266 that extends over substantially the entire length in the up-down direction is protruded outward at substantially the center in the width direction of the wall portion 264a.
  • a penetrating window 268 is formed above the wall 264b so as to penetrate the wall 264b.
  • a positioning protrusion 270 protruding outward is provided at each upper end portion of the wall portion 264c.
  • the bottom wall portion 262 is formed in a substantially disc shape having an outer diameter larger than the cylindrical portion 260, and protrudes in a flange shape at the lower end of the puncture rod 218.
  • a substantially cylindrical spring support portion 271 that protrudes into the cylindrical portion 260 and supports the lower end of the puncture spring 214 is provided on the upper surface of the bottom wall portion 262.
  • the puncture rod 218 as described above is inserted into the peripheral wall portion 248 of the inner housing 222 from below in the tubular portion 260 and assembled. Further, a guide ridge 266 provided on the outer surface of the wall portion 264a of the cylindrical portion 260 is inserted into a guide groove 252 provided on the inner surface of the wall portion 250a of the peripheral wall portion 248, and provided on the wall portion 250c. The positioning protrusion 270 provided on the wall portion 264c is inserted into the cutout 256.
  • the lid 240 of the inner housing 222 and the puncture rod 218 are vertically opposed to each other, and the puncture rod 218 and the inner housing 222 can be moved in the up and down direction, that is, in a direction approaching each other and separated from each other. Relative movement is possible.
  • the outer diameter of the bottom wall portion 262 of the puncture rod 218 is smaller than the inner diameter of the collar portion 258 of the inner housing 222, and the upward moving end of the puncture rod 218 with respect to the inner housing 222 is, for example, a bottom. It can be defined by the outer peripheral portion of the wall portion 262 hitting the lower end portion of the peripheral wall portion 248, or can be defined by the puncture rod 218 abutting on a pressurizing rod 272 as a pressing force transmitting member described later. Further, the downward moving end of the puncture rod 218 with respect to the inner housing 222 can be defined by, for example, the positioning projection 270 hitting the lower end of the notch 256.
  • a pressurizing rod 272 as a pressing force transmitting member is disposed between the puncture rod 218 and the inner housing 222 in the vertical direction.
  • the pressure rod 272 has a substantially bottomed cylindrical shape that opens upward as a whole, and has a cylindrical portion 274 extending vertically and a substantially circular bottom plate that closes a lower opening of the cylindrical portion 274. 276.
  • the outer diameter of the cylindrical portion 274 is smaller than the inner dimension of the cylindrical portion 260 of the puncture rod 218, and the inner diameter of the cylindrical portion 274 is smaller than that of the spring support projecting downward from the lid 240.
  • the outer dimensions of the portion 246 are made larger.
  • the upper end portion of the cylindrical portion 274 has an outer peripheral cylindrical portion 278 that extends downward so as to be folded back to the outer peripheral side, and is provided between the cylindrical portion 274 and the outer peripheral cylindrical portion 278 in the radial direction.
  • a substantially annular spring support portion 280 that opens downward and supports the upper end portion of the puncture spring 214 is formed.
  • a thick portion 282 having a large thickness is provided on a part of the outer peripheral cylindrical portion 278 on the periphery (left side in FIG. 19), and the inner housing 222, the pressure rod 272, At the time of assembling, the thick portion 282 is inserted into the guide groove 252 provided on the inner surface of the wall portion 250a of the inner housing 222. Accordingly, the inner housing 222 and the pressure rod 272 are positioned relative to each other in the circumferential direction, and are movable while being guided in the up-down direction.
  • locking projections 284 protruding toward the outer circumference are provided on both sides of the outer circumferential cylindrical portion 278 in one radial direction (both sides in the front-rear direction in FIG. 19).
  • the locking projections 284 and 284 are formed at positions corresponding to the notches 256 and 256 provided in the walls 250 c and 250 c of the inner housing 222, and the inner housing 222 and the pressure rod are formed.
  • each locking projection 284 is located in the corresponding notch 256.
  • the locking projection 284 is provided on the upper end surface of the locking projection 284 in a moving direction (a direction from left to right in FIG. 19) of the pressing button 372 described later.
  • An inclined surface 286 that is inclined in a direction in which the thickness dimension (vertical dimension) decreases is formed.
  • the inner housing 222, the puncture rod 218, and the pressure rod 272 are mutually assembled. That is, the spring support portion 246 projecting downward from the lid portion 240 of the inner housing 222 is inserted from above into the cylindrical portion 274 of the pressure rod 272, and the cylindrical portion 274 is inserted into the puncture rod 218.
  • the inner housing 222, the puncture rod 218, and the pressure rod 272 are arranged substantially coaxially and in series in the vertical direction from the upper opening of the cylindrical portion 260. ing.
  • a puncture spring 214 which is a compression coil spring, is disposed between the puncture rod 218 and the pressure rod 272 in the vertical direction. That is, the puncture spring 214 is externally inserted into the cylindrical portion 274 of the pressure rod 272 and is inserted into the cylindrical portion 260 of the puncture rod 218, so that the upper end portion of the puncture spring 214 becomes the spring support portion 280 of the pressure rod 272. While the lower end portion of the puncture spring 214 is fixed to the spring support 271 of the puncture rod 218. As a result, the puncture spring 214 is compressed, so that a downward urging force is applied to the puncture rod 218. In the storage state of the applicator 210 shown in FIG. 19 and the initial state in which a cover 394 and a cap 392 described later are removed from the state shown in FIG. 19 (FIG. 22 described later), the puncture spring 214 has a substantially natural length. Have been.
  • a pressure spring 288 as an additional external force generating member is disposed between the pressure rod 272 and the inner housing 222 in the vertical direction.
  • the pressure spring 288 is constituted by a compression spring member (compression coil spring). That is, the pressing spring 288 is inserted into the spring supporting portion 246 of the inner housing 222 and is inserted into the cylindrical portion 274 of the pressing rod 272 so that the upper end of the pressing spring 288 is The lower end of the pressure spring 288 is fixed to the bottom plate 276 of the pressure rod 272 while being fixed to 240. As a result, the pressing spring 288 is compressed, so that a downward urging force is applied to the pressing rod 272.
  • the pressure spring 288 is assembled in a compressed state in the storage state shown in FIG.
  • a movable cylinder 290 having a substantially cylindrical shape as a whole is assembled to the housing 212 so as to be movable in the vertical direction.
  • the peripheral wall portion 292 has a substantially octagonal shape.
  • an insertion port 294 is provided at a part (left side in FIG. 19) on the periphery of the peripheral wall portion 292.
  • the insertion port 294 has a cutout window shape opened downward. As described later, the user can easily insert his / her finger into the movable cylinder 290 from the outside of the movable cylinder 290 through the insertion port 294.
  • a part of the peripheral wall portion 292 on the periphery (left side in FIG. 19) is formed with a contact plate portion 296 projecting upward.
  • the contact plate portion 296 is provided with projecting contact portions 298 and 298 projecting from both sides in the width direction (the circumferential direction of the peripheral wall portion 292).
  • Each projecting contact portion 298 extends downward from the upper end of the contact plate portion 296 by a predetermined length, and the lower end of the projecting contact portion 298 is an inclined surface 300.
  • the projecting contact portion 298 is not provided, and a notch-like contact avoidance region 302 is formed.
  • a guide recess 304 is formed substantially at the center of the inner surface of the contact plate portion 296 in the width direction and extends over substantially the entire length in the vertical direction.
  • a substantially cylindrical spring housing portion 306 that opens upward is formed on the peripheral wall portion 292.
  • a pair of spring accommodating portions 306, 306 are provided so as to be opposed to each other in a direction perpendicular to the axis of the peripheral wall portion 292 (a direction toward the front of the paper in FIG. 19).
  • the spring accommodating portion 306 projects above the peripheral wall portion 292 of the movable cylinder 290.
  • pressing portions 308 are protrudingly provided on the mutually facing inner surfaces of the pair of spring housing portions 306.
  • the front surface (left surface in FIG. 19) on the puncture button 322 side which will be described later, faces toward the rear (right side in FIG. 19) that moves away from the puncture button 322 as it goes down.
  • An inclined surface 310 is inclined (see FIG. 31).
  • the movable cylinder 290 is provided with a pair of case holding portions 312 and 312 for holding a case 410 of the microneedle 216 described later, protruding below the pair of spring housing portions 306 and 306.
  • Each case holding portion 312 has a substantially rectangular frame shape, and a claw portion 314 protruding inward is provided substantially at the center of the lower side portion.
  • the inner surface of the claw portion 314 is provided with irregularities, and can be engaged with the irregularities provided on the outer peripheral surface of the case 410 of the microneedle 216 as described later.
  • a stopper 316 that protrudes downward is provided on the rear side of the peripheral wall portion 292 of the movable cylinder 290 that radially opposes the inlet 294.
  • the stopper 316 defines a moving end for pushing the case 410 backward.
  • the peripheral wall 292 of the movable cylinder 290 is located between the peripheral wall 226 of the outer housing 220 and the peripheral wall 248 of the inner housing 222.
  • Guide protrusions 234 of the support wall portion 232 a of the outer housing 220 are inserted into guide recesses 304 provided on the contact plate portion 296 of the movable cylinder 290, and guides the guide protrusions 234 and the guide recesses 304.
  • a pair of compression springs 318, 318 each having a lower part inserted into a pair of spring accommodating portions 306, 306, 318, which are made of a pair of compression coil springs, are arranged in a direction in which they are vertically separated from each other.
  • the power has been exerted. That is, the movable cylinder 290 and the housing 212 relatively move in the direction of approaching each other, so that the pressing springs 318, 318 are compressed and deformed, and the movable spring 318, 318 are elastically restored and deformed.
  • the housing 212 and the housing 212 are relatively moved in a direction away from each other.
  • each presser spring 318 is externally inserted into, for example, a spring holding portion 320 (see FIG. 28) projecting downward from the upper bottom wall portion 224 of the outer housing 220. It is fixed to the inner surface of the wall 224.
  • Puncture button 322 for performing a puncturing operation of the microneedle 216 and a lock lever 324 are attached to the housing 212.
  • Puncture button 322 is fitted into puncture button hole 236 so as to be able to enter and exit, and punctures button body 326 protruding outside of outer housing 220, and spreads inside punctures button hole 236 to prevent escape from outer housing 220.
  • a flange portion 328 that is provided.
  • engaging protrusions 330, 330 protruding inward are provided at both ends of the flange 328 in the width direction (forward and backward in the paper surface in FIG. 19).
  • An inclined surface 332 (see FIG. 20) whose projection height gradually increases downward is provided on the projecting distal end surface of each engagement projection 330.
  • the lock lever 324 is a substantially rectangular frame-shaped member as a whole, and the peripheral wall portion 334 has a substantially flat plate-shaped wall portion 336a, 336b opposed in the front-rear direction and a left-right direction. It is composed of walls 336c, 336c.
  • the notch-shaped through-grooves 338, 338 that open upward are provided on the front wall 336a of the peripheral wall 334 at positions corresponding to the engagement projections 330, 330 of the puncture button 322. Then, the flange portion 328 of the puncture button 322 is superposed on the wall portion 336a from the outside, and the engaging protrusion 330 is inserted into the through groove 338 and protrudes inward of the peripheral wall portion 334 of the lock lever 324. I have.
  • the rear wall portion 336b of the peripheral wall portion 334 has a spring support portion 340 protruding outwardly (rearward) of the peripheral wall portion 334 from substantially the center in the circumferential direction, and a locking portion protruding inwardly (frontward). 342 are provided. Further, the lower surface of the protruding tip end of the locking portion 342 is an inclined surface whose inward protruding height increases as going upward. In the present embodiment, the inclined curved surface 344 is inclined while being curved. ing. On the other hand, the upper surface of the locking portion 342 is a flat surface 346 that extends substantially horizontally.
  • each of the left and right side walls 336c, 336c of the peripheral wall 334 is provided with an opening groove 348 that opens outward and extends over substantially the entire length in the vertical direction.
  • an inclined surface 350 (see FIG. 20) that is inclined in a direction of decreasing the groove width toward the lower side is provided on the inner surface of the opening groove 348 on the front side of the groove.
  • a cylinder lock 352 for preventing the movable cylinder 290 from moving upward is provided.
  • the cylinder lock 352 is a substantially rectangular frame-shaped member as a whole, and a peripheral wall portion 354 has a pair of wall portions 356c opposed to each other in the left-right direction with substantially flat wall portions 356a and 356b opposed in the front-rear direction. , 356c.
  • the rear wall portion 356b is provided with a spring support portion 358 projecting outward (rearward) from a substantially center in the circumferential direction and an engaging portion 360 projecting inward (frontward).
  • the lower surface of the projecting distal end of the engaging portion 360 is an inclined surface that inclines upward toward the projecting distal end, and in the present embodiment, is an inclined curved surface 362 that is inclined while being curved.
  • each of the left and right wall portions 356c, 356c is provided with a contact projection 364 projecting downward.
  • one of the left and right wall portions 356c, 356c (in this embodiment, the wall portion 356c on the back side of the paper in FIG. 19) extends from the middle portion in the length direction (the left and right direction in FIG. 19).
  • An engaging claw portion 366 protruding upward is provided.
  • the engaging claw portion 366 protrudes upward with a predetermined width dimension (horizontal dimension in FIG. 19), and has an upper end bent inward in a direction opposite to the left and right wall portions 356c, 356c.
  • a bent portion 368 is provided.
  • a front portion on the upper end surface of the bent portion 368 is a colored portion 370 (see FIG. 34 described later) colored in a different color from the rear portion.
  • the rear portion of the upper end surface of the bent portion 368 is colorless (white), and the front portion (colored portion 370) is colored gray.
  • the color of the rear part are not limited at all.
  • a pressure button 372 that allows the pressure rod 272 to move downward is provided.
  • the pressure button 372 has a substantially rectangular frame-shaped peripheral wall portion 374 as a whole, and the peripheral wall portion 374 is located forward and protrudes from the pressure button hole 238 of the housing 212.
  • a holding portion 378 projecting downward is provided at a predetermined length in an intermediate portion in the length direction (the left-right direction in FIG. 19) of the left and right wall portions 376c.
  • the holding portions 378 face each other at a predetermined distance in the left-right direction, and a locking projection 380 that protrudes inward in the facing direction is formed on the inner surface of the holding portion 378.
  • an inclined curved surface 382 is provided on the front end face of the lower end of the locking projection 380.
  • a spring support portion 384 is formed on a rear wall portion 376b of the peripheral wall portion 374 so as to protrude outward (rearward) from substantially the center in the circumferential direction.
  • the lock lever 324, the cylinder lock 352, and the press button 372 are respectively punctured with a puncture button spring 386 and a lock spring formed of a compression coil spring extending in the front-rear direction with respect to the outer housing 220 that houses them. 388 and the press button spring 390.
  • One end of the puncture button spring 386 is externally inserted into the spring support portion 340 of the lock lever 324, and the other end is supported on the opposed inner surface of the outer housing 220.
  • one end of the lock spring 388 and the pressure button spring 390 is externally inserted into the spring support portion 358 of the cylinder lock 352 and the spring support portion 384 of the pressure button 372, and the other end of the outer housing 220 has the other end. It is supported on the opposing inner surface.
  • the lock lever 324, the cylinder lock 352, and the pressing button 372 are urged toward the front of the outer housing 220, and are positioned in front of the lock lever 324.
  • the puncture button main body 326 of the puncture button 322 protrudes from the puncture button hole 236 of the outer housing 220, and the press button main body 376a of the press button 372 protrudes from the press button hole 238 of the outer housing 220. ing.
  • the lock lever 324, the cylinder lock 352, and the press button 372 are vertically overlapped, and these members 324, 352, and 372 are connected to the support wall portion 232b of the outer housing 220 and the inner housing 222 in the housing 212.
  • a locking portion 342 that protrudes inward from the wall portion 336b of the lock lever 324 while being vertically sandwiched and supported by the wall portion 250b (and a rib protruding outward from the wall portion 250b).
  • An engagement portion 360 protruding inward from a wall portion 356b of the cylinder lock 352 is inserted into a notch 254 provided in the wall portion 250b of the inner housing 222.
  • an engagement claw 366 protruding upward from the cylinder lock 352 is engaged with the wall 376c of the press button 372 (the bent portion 368 is in contact with the upper end surface of the wall 376c).
  • the holding portions 378, 378 projecting downward from the walls 376c, 376c of the pressing button 372 are inserted inside the walls 356c, 356c of the cylinder lock 352 and abut inside and outside.
  • the puncture button 322, the lock lever 324, the cylinder lock 352, and the pressurizing button 372 are assembled in a state where they are positioned in the up-down direction with respect to the housing 212, and the members 322, 324, 352, and 372 are attached.
  • the spring 386 for puncturing button, the spring 388 for locking, and the spring 390 for pressing button are accompanied by deformation, so that they can be moved in the front-rear direction.
  • the applicator 210 punctures the button 322, the lock lever 324, the cylinder lock 352, and the pressure button 372 together with the puncture button spring 386, the lock spring 388, and the pressure button spring 390 on the outer housing 220.
  • After assembling it is manufactured by sequentially assembling the inner housing 222, the pressure spring 288, the pressure rod 272, the pressing springs 318, 318, the movable cylinder 290, the puncture spring 214, and the puncture rod 218 from the lower opening of the outer housing 220.
  • the order of assembling is not limited at all.
  • the pressing spring 288 provided between the inner housing 222 and the pressing rod 272 in the up-down direction is held in a compressed state. That is, in the state before use shown in FIG. 19, the lower surface of the lid 240 of the inner housing 222 to which the upper end of the pressure spring 288 is fixed and the bottom plate of the pressure rod 272 to which the lower end of the pressure spring 288 is fixed.
  • the separation distance from the upper surface of the pressure spring 276 is shorter than the natural length of the pressure spring 288, and a downward urging force is exerted on the pressure rod 272 based on the elastic restoring force of the pressure spring 288. ing.
  • the downward movement of the pressure rod 272 is prevented. That is, in a state before the applicator 210 is used, as shown in FIG. 34 to be described later, the locking projection 284 protruding from the outer peripheral cylindrical portion 278 of the pressing rod 272 to the outer peripheral side is pressed. 372 are locked by locking protrusions 380 that protrude inward from the left and right wall portions 376c. As a result, the downward movement of the pressure rod 272 based on the urging force of the pressure spring 288 is prevented by the locking projection 284 being locked by the locking projection 380. That is, in the present embodiment, the movement lock mechanism 391 that positions and holds the pressure rod 272 upward and prevents the downward movement is configured to include the locking protrusion 284 and the locking protrusion 380. .
  • the locking projection 284 is locked to the locking projection 380 by pressing the pressing rod 272 against the pressing button 372 from below, and the locking projection 284 gets over the locking projection 380. It has become so. That is, by attaching the pressure rod 272 to the outer housing 220 to which the pressure button 372 is attached, the inclined surface 286 of the locking projection 284 of the pressure rod 272 and the locking projection 380 of the pressure button 372 are formed. The pressurizing button 372 is pushed backward with the compressive deformation of the pressurizing button spring 390 due to the contact with the inclined curved surface 382.
  • the puncture spring 214, the holding springs 318, 318, the puncture button spring 386, the lock spring 388, and the pressure button spring 390 provided inside the applicator 210 are all in their natural length or slightly initial compression state.
  • the bottom wall portion 262 of the puncture rod 218 is located inside the peripheral wall portion 292 of the movable cylinder 290 and is exposed to the external space.
  • the bottom wall 262 of the puncture rod 218 can be accessed through the insertion port 294 provided in the section 292.
  • the puncture rod may protrude outside (below) the movable cylinder.
  • puncturing button 322 punctcturing button main body 326) and pressurizing button 372 (pressing button main body 376a) are connected to puncturing button hole 236 and pressurizing button hole of housing 212 (outer housing 220). 238 protrudes outward.
  • the lock lever 324 and the cylinder lock 352 have the inclined curved surfaces 344 and 362 provided at the protruding distal ends of the locking portion 342 and the engaging portion 360 provided inside thereof.
  • the wall portion 264b of the tubular portion 260 of the puncture rod 218 is arranged at a position overlapping with the vertical projection.
  • a cap 392 that covers the puncture rod 218 projecting from the housing 212 from the outside is provided, and a cover 394 that covers the lower opening of the housing 212 from the outside is provided. The contact of the puncture rod 218 which does not occur is prevented.
  • the cap 392 has a cup shape having a bottom wall 396 and a substantially cylindrical peripheral wall 398.
  • a flange portion 400 protruding to the outer periphery is provided on the peripheral edge of the opening of the peripheral wall portion 398.
  • the outer diameter of the flange 400 is substantially equal to the inner diameter of the peripheral wall 292 of the movable cylinder 290, and is inserted from the lower opening of the movable cylinder 290 with the opening of the cap 392 facing upward.
  • the flange 400 of the cap 392 is substantially fitted into the peripheral wall 292 of the movable cylinder 290, and the cap 392 is removably assembled to the movable cylinder 290.
  • the puncture rod 218 protruding from the housing 212 is covered from the outside, and a gap is set between the puncture rod 218 and the cap 392, so that an external force applied to the cap 392 is applied to the puncture rod. 218.
  • the cover 394 is covered on the housing 212 from below.
  • the cover 394 has a substantially cup shape as a whole, and includes a bottom wall portion 402 and a peripheral wall portion 404 having a substantially octagonal shape.
  • the peripheral wall portion 404 is detachably fitted to the peripheral wall portion 226 of the housing 212 (outer housing 220) so as to protect the movable cylinder 290 and the puncture rod 218 from external force. .
  • the protruding contact portions 298, 298 which are the upper ends of the contact plate portions 296 of the movable cylinder 290.
  • the contact protrusions 364 and 364 projecting downward from the wall portions 356c and 356c of the cylinder lock 352 are in contact with each other in the vertical direction. Accordingly, the movable cylinder 290 is prevented from moving toward the housing 212 in a state before use.
  • the movement restricting means 406 that prevents the movable cylinder 290 from moving toward the housing 212 is provided by these movable limiters. It includes a projecting contact portion 298 of the cylinder 290 and a contact projecting portion 364 of the cylinder lock 352.
  • the movable cylinder 290 is allowed to move toward the housing 212 by pushing the puncture rod 218 toward the housing 212, so that the direct contact of the puncture rod 218 is prevented.
  • the cover 394 can be used without providing the cylinder lock 352 and the cap 392.
  • the movement restricting means 406 may be constituted, or the movement restricting means 406 may be constituted by providing a cylinder lock 352 and a cap 392 and further including a cover 394.
  • the engaging protrusion 330 protruding inward from the puncture button 322 is inserted into the peripheral wall through the through groove 338 provided in the wall 336a of the lock lever 324.
  • the protruding tip of the engagement protrusion 330 extends in the front-rear direction with respect to the protrusion contact portion 298 of the contact plate 296 of the movable cylinder 290 provided inside the wall 336a. It comes in contact with. Accordingly, in the state before use, the pushing operation of puncturing button 322 is disabled.
  • safety mechanism 408 that disables puncturing button 322 is provided by engaging projection 330 of puncturing button 322. And a protruding contact portion 298 of the movable cylinder 290.
  • the cover 394 and the cap 392 are sequentially removed from the storage state shown in FIG. 19 to obtain an initial state before use shown in FIG. Then, from this initial state, the puncture rod 218 is pushed into the housing 212 as shown in FIG. That is, by pressing the bottom wall portion 262 of the puncture rod 218 with a finger inserted from the insertion port 294 of the movable cylinder 290, the puncture rod 218 is pushed above the housing 212 while compressing and deforming the puncture spring 214.
  • the puncture rod 218 When the puncture rod 218 is pushed into the housing 212, the guide action between the guide ridge 266 of the puncture rod 218 and the guide groove 252 of the inner housing 222 and the positioning protrusion 270 of the puncture rod 218 cause the cutting of the inner housing 222.
  • the puncture rod 218 is pushed into the housing 212 without inclining due to the guide action by fitting into the notch 256.
  • the applicator 210 is shown in a state where the applicator 210 is turned upside down from the state shown in FIG. 19.
  • the operation may be performed to push down the puncture rod 218, but the pushing direction of the puncture rod 218 is not limited at all.
  • the pushing operation of the puncture rod 218 into the housing 212 causes the puncture rod 218 to move upward, and the inclination of the locking portion 342 projecting inward from the upper end of the wall portion 264 b and the lock lever 324 of the puncture rod 218.
  • the surface 344 abuts.
  • the lock lever 324 is moved backward while the puncture button spring 386 is compressed and deformed.
  • the puncture rod 218 When the puncture rod 218 is further pushed into the housing 212, the upper end of the wall portion 264b of the puncture rod 218 comes into contact with the inclined curved surface 362 of the engagement portion 360 that projects inward from the cylinder lock 352. .
  • the cylinder lock 352 When the puncture rod 218 is further pushed in from the contact state, the cylinder lock 352 is moved rearward while the locking spring 388 is compressed and deformed. Thereby, the contact between the projecting contact portion 298 of the movable cylinder 290 and the contact projection 364 of the cylinder lock 352 in the movement restricting means 406 for preventing the movable cylinder 290 from moving toward the housing 212 is released. The movement of the movable cylinder 290 toward the housing 212 is allowed.
  • the releasing means that releases the movement restricting means 406 to allow the movable cylinder 290 to move toward the housing 212 moves the projecting contact part 298 and the contact projection 364 into the non-contact state. It is constituted by the mechanism which does. Therefore, in the present embodiment, the movement of the movable cylinder 290 is prevented by the contact between the movable cylinder 290 and the cylinder lock 352, and the movement of the movable cylinder 290 is allowed by the release of the contact between the movable cylinder 290 and the cylinder lock 352. The movement of the lock 352 is selectively realized.
  • the rear part of the upper end surface of the bent portion 368 of the cylinder lock 352 was visually recognized from the window 229 of the outer housing 220, but after the movement of the cylinder lock 352, in FIG.
  • the dashed line indicating the area visible by the window 229 moves into the colored portion 370, and the front portion (colored portion 370) having a different color from the rear portion of the upper end surface of the bent portion 368 is visually recognized from the window 229. It has become so. That is, it is possible to confirm whether or not the cylinder lock 352 is moving, that is, whether or not the puncture rod 218 is pushed into the housing 212, in accordance with the color visually recognized from the window portion 229.
  • a mechanism for checking whether the cylinder lock 352 is moved by the window 229 is not essential, that is, the window 229 and the coloring part 370 are not essential.
  • the case 410 holding the microneedle 216 is attached to the movable cylinder 290 of the applicator 210 as shown in FIGS.
  • the case 410 includes a case main body 412 that holds the microneedle 216 and a case cover 414 that covers the case main body 412 from outside.
  • the case main body 412 of the present embodiment has a substantially annular shape as a whole, and an outer peripheral flange portion 418 and an inner peripheral flange portion 420 (see FIG. 30) are formed at the upper end of the cylindrical wall portion 416.
  • the outer diameter of the cylindrical wall 416 is substantially equal to the distance between the case holding portions 312 and 312 in the movable cylinder 290, and the inner diameter of the inner peripheral flange 420 of the cylindrical wall 416 is punctured.
  • the outer diameter of the bottom wall 262 of the rod 218 is larger than that of the rod 218.
  • the outer peripheral surface of the cylindrical wall portion 416 has irregularities.
  • ⁇ Circle around (4) ⁇ The outer peripheral portion of the substantially circular pressure-sensitive adhesive sheet 422 is overlapped and fixed to the inner peripheral flange portion 420.
  • a microneedle 216 is fixed at a central portion, and is disposed in a center hole of the inner peripheral flange portion 420.
  • the microneedle 216 is configured to include a needle main body 424 formed of a plurality of minute solid needles and a base 426 to which the needle main body 424 is fixed. The drug to be administered to the patient is applied to the needle body 424.
  • the case cover 414 has a substantially U-shape as a whole, and includes a pair of cover portions 428, 428 that sandwich the case body 412 from both the upper and lower sides, and a portion of the cover portions 428, 428 on the periphery. And a connection unit 430 for connecting the terminals with each other.
  • the case cover 414 is detachable from the case body 412 toward the side.
  • the case 410 can be attached to and detached from the movable cylinder 290 through the inlet 294 with the case cover 414 attached to the case main body 412.
  • the outer peripheral flange 418 is sandwiched between the claw 314 of the case holder 312 and the peripheral wall 292 in the vertical direction, and the outer peripheral surface of the cylindrical wall 416. And the unevenness provided on the claw portion 314 are engaged with each other.
  • the microneedle 216 is exposed to the outside.
  • the applicator 210 to which the case body 412 provided with the microneedle 216 is attached is pressed against the patient's skin on the lower surface of FIGS. 27 and 28 where the microneedle 216 is exposed. That is, the housing 212 is pushed downward with the lower end of the cylindrical wall portion 416 of the case body 412 in contact with the patient's skin, and the housing 212 and the case body 412 are displaced toward each other. 28 and FIG. 31, which will be described later, illustration of the pressure rod 272, the pressure spring 288, and the spring support 246 located inside the puncture spring 214 is omitted.
  • the safety projection 408 of the puncture button 322 and the projection contact portion 298 of the movable cylinder 290 abut against each other to form the safety mechanism 408, and the puncture operation is performed.
  • the movable cylinder 290 moves upward in the housing 212 (moves toward the housing 212 side), so that the engagement protrusion 330 and the protrusion contact portion 298 come into contact with each other. Is released, and the engagement protrusion 330 is moved to the contact avoidance region 302 located below the protrusion contact portion 298. Thereby, the safety mechanism 408 is released, and the puncture button 322 can be pushed in through the puncture button hole 236 of the housing 212.
  • the pressing portion 308 provided on the spring housing portion 306 of the movable cylinder 290 is provided on the wall portion 336 c of the lock lever 324.
  • the inclined surface 310 provided in the pressing portion 308 and the inclined surface 350 provided in the open groove 348 face each other in the front and rear direction while being separated from each other.
  • the puncture button 322 is pressed and pushed in, whereby the microneedle 216 is punctured as shown in FIGS. 32 and 33 show a state in which the pressing of the puncture button 322 has been released after the microneedle 216 has been punctured. That is, the puncture button 322 and the lock lever 324 located inside the puncture button 322 are moved rearward with the compression deformation of the puncture button spring 386 from the state shown in FIGS. The locking of the locking portion 342 by the window 268 is released, and the puncture rod 218 is moved downward based on the elastic restoring force of the puncture spring 214.
  • the movement of the lock lever 324 in response to the pressing operation of the puncture button 322 causes the inclined surface 310 of the pressing portion 308 of the movable cylinder 290 and the inclined surface 350 of the opening groove 348 of the lock lever 324 to mutually move. It comes into contact.
  • the pressing of the puncture button 322 is released and the applicator 210 is separated from the skin, and the movable cylinder 290 is elastically restored by the puncture button spring 386 and the pressing spring 318.
  • the lock lever 324 is moved to the initial position, the two members 290, 324 can be stably moved to the initial position.
  • the lower end portion of the puncture rod 218 passes through the inside of the case main body 412, and the bottom wall portion 262 of the puncture rod 218 causes the microneedle 216 to protrude downward from the housing 212, The microneedles 216 are pressed against the skin together with the adhesive sheet 422 to puncture.
  • the lock lever 324 is returned to the initial position by the elastic restoring force of the puncture button spring 386 as shown in FIGS. It is designed to return. Further, the contact between the wall portion 264b of the puncture rod 218 and the engaging portion 360 of the cylinder lock 352 is released with the downward movement of the puncture rod 218.
  • the cylinder lock 352 returns to the initial position, so that the color of the rear portion (colorless (white) in the present embodiment) of the upper end surface of the bent portion 368 is provided from the window portion 229 of the outer housing 220. It has become visible.
  • the puncture button 322 When the puncture button 322 is pushed in to release the locking of the locking portion 342 by the penetrating window 268 in this manner, the puncture rod 218 moves downward by the elastic restoring force of the puncture spring 214, and the microneedle 216 Is thought to be instantaneously punctured into the skin.
  • the following mechanism may be employed in order to realize the puncture depth of the microneedle 216 into the skin and to stabilize the puncture state.
  • the puncture button 322 is operated to puncture the microneedle 216 using the restoring force of the puncture spring 214, and then the pressing button 372 is further pressed to operate the housing 212 with respect to the microneedle 216.
  • the microneedle 216 is further pushed into the skin by applying an additional external force in the protruding direction (downward) from the, and the puncture state is more stably maintained. That is, before the pressing operation of the pressing button 372, as shown in FIG. 34, the moving lock mechanism is brought into contact with the locking projection 284 of the pressing rod 272 and the locking projection 380 of the pressing button 372. 391 is configured to prevent the pressure rod 272 from moving downward due to the urging force of the pressure spring 288.
  • the pressure rod 272 is moved downward with the restoration deformation.
  • the amount of compression of the puncture spring 214 supported between the pressure rod 272 and the puncture rod 218 is increased, and the elastic restoring force of the pressure spring 288 is increased via the puncture spring 214 by the puncture rod.
  • the microneedle 216 is kept punctured by the skin.
  • the puncture spring 214 forms the buffer means for buffering the applied external force to the microneedle 216, and the buffering external force applying mechanism for applying the buffered external force is pressurized. It is configured to include a spring 288 and a pressure rod 272.
  • the puncture spring 214 also functions as urging means for urging the microneedle 216, and the buffer means is constituted by the urging means.
  • the additional external force generating member that generates the additional external force is configured by the pressure spring 288, and the additional external force generated by holding the pressure spring 288 in a compressed state is applied.
  • the puncture spring 214 and the microneedle 216 are applied via a pressure rod 272 as a pressure transmission member.
  • Such a state where the microneedle 216 punctures the skin is achieved when the user presses the applicator 210 against the skin. That is, in a state where the user presses the applicator 210 against the skin and punctures with the puncture spring 214, the microneedle 216 continuously exerts an additional external force by the pressure spring 288 on the microneedle 216, so that the microneedle 216 In addition to being punctured at a predetermined depth (for example, to the base), the state of puncturing of the microneedle 216 into the skin is continuously maintained for a predetermined time, so that the drug applied to the microneedle 216 is Can be realized more reliably.
  • the time for pressing the microneedle 216 against the skin is not limited at all, but the user removes the applicator 210 from the skin after a predetermined time has elapsed. In the present embodiment, even after the applicator 210 is removed, the microneedles 216 are attached to the skin with the adhesive sheet 422, so that the puncture state to the skin can be maintained.
  • the puncturing rod 218 is locked by the lock lever 324 and is held in the housing 212.
  • the rod 272 abuts on the puncture rod 218 and is restricted from moving downward. That is, in the present embodiment, the pressing operation of the pressing button 372 before the pressing operation of the puncturing button 322 is restricted. In other words, when the puncture button 322 is pressed, the pressing button 372 is pressed to allow the pressing rod 272 to move downward (the movement lock mechanism 391 is released).
  • the state in which the microneedles 216 puncture the skin is continuously maintained for a predetermined period of time.
  • Transdermal administration can be more reliably achieved.
  • an additional external force is applied to the microneedle 216 to press against the skin, and the additional external force causes the puncture spring 214 to be applied to the microneedle 216 (the puncture rod 218).
  • the puncture spring 214 causes the puncture spring 214 to be applied to the microneedle 216 (the puncture rod 218).
  • the buffer Therefore, an impulsive load is prevented from being exerted on the microneedle 216, and the risk that the patient feels pain can be effectively reduced.
  • the urging means for urging the microneedle 216 and the buffer means for buffering the external force applied to the microneedle 216 are both constituted by the same puncturing spring 214, Simplification and reduction of the number of members can be achieved.
  • the initial puncture force of the microneedle 216 by the puncture spring 214 and the additional external force by the pressurizing spring 288 are appropriately set for each of the puncture spring 214 and the pressurizing spring 288 by separately setting the spring constant and the compression ratio. It is possible to adjust.
  • the pressurizing spring 288 is provided as an additional external force generating member for generating an additional external force to the microneedle 216. According to the pressing operation of the pressurizing button 372, even after the pressing of the pressurizing button 372 is released. Since the pressurized state of the microneedle 216 is maintained, a troublesome operation such as continuously applying an external force due to human power as an additional external force between the housing 212 and the microneedle 216 is avoided, and a good operation is achieved. Sex can be exhibited.
  • the movement lock mechanism 391 that prevents the movement of the pressure rod 272 is provided, and the movement of the pressure rod 272 is prevented from being performed unintentionally.
  • the pressurizing rod 272 since the pressurizing rod 272 is prevented from moving by the movement lock mechanism 391 before the puncture button 322 is pressed, the pressurizing rod 272 is inserted before the microneedle 216 is punctured into the skin. Are prevented from moving.
  • the movable cylinder 290 is prevented from moving into the housing 212 before the puncture rod 218 is pushed into the housing 212, for example, before the puncture rod 218 is pushed into the housing 212. Then, the microneedle 216 (case 410) is mounted on the movable cylinder 290, and in this state, the erroneous puncture of the microneedle 216 caused by pressing the applicator 210 against the skin can be stably prevented.
  • a microneedle applicator (hereinafter, applicator) 440 is in a puncture preparation state (puncture rod 218 and movable cylinder 290 are pushed into housing 442 side).
  • FIG. 37 shows the applicator 440 in a state where the outer housing 444 and the cylinder lock 352 are omitted.
  • the applicator 440 of the present embodiment is different from the applicator (210) of the third embodiment in a mechanism for applying an additional external force to the punctured microneedle 216 to press the microneedle 216 against the skin. ing.
  • the mechanism for attaching the case 410 holding the microneedle 216 to the applicator 440 and puncturing the microneedle 216 into the skin is substantially the same as that of the third embodiment. Substantially the same members and portions are denoted by the same reference numerals in the drawings as in the above-described embodiment, and detailed description thereof is omitted.
  • the outer housing 444 of the present embodiment has substantially the same structure as the outer housing (220) of the third embodiment, and thus detailed description is omitted. However, the outer housing (220) of the third embodiment is omitted. ), The peripheral wall portion 226 is provided with only the puncture button hole 236 without providing the pressure button hole (238).
  • the inner housing 446 has a substantially inverted bottomed cylindrical shape, similarly to the third embodiment, and has a vertical portion at the center of the lid portion 240 corresponding to the upper bottom wall portion.
  • a pressure boss hole 448 penetrating in the direction is formed.
  • a pressure boss member 450 having a substantially cylindrical shape with a bottom and substantially in the opposite direction as a whole is disposed inside the inner housing 446.
  • the boss body 452 projects upward through a pressure boss hole 448 at the center of the lid 240.
  • a flange-shaped portion 454 protruding to the outer peripheral side is provided at the lower end of the pressure boss body 452. Note that the outer diameter of the flange-shaped portion 454 is larger than the inner diameter of the pressure boss hole 448, so that the pressure boss member 450 is prevented from falling outside through the pressure boss hole 448. I have.
  • a notch-shaped opening groove 456 that opens to the outer peripheral side and extends in the up-down direction is formed.
  • a pair of opening grooves 456 and 456 are formed in the lower right and upper left portions of FIG.
  • an inclined surface 458 is formed at an upper end portion of the inner surface on the front side of the opening groove 456 so as to be inclined forward as it goes upward.
  • the puncturing spring 214 is disposed between the pressing boss member 450 and the puncturing rod 218 in the vertical direction.
  • the inner diameter of the flange portion 454 is larger than the inner diameter of the pressing boss body 452, and the inner peripheral surface of the pressing boss body 452 and the flange portion 454 are formed.
  • An annular step surface 460 (see FIG. 39 and the like) extending in a direction perpendicular to the axis (a direction perpendicular to the vertical direction) is formed between the inner peripheral surface and the inner peripheral surface.
  • the upper end portion of the puncture spring 214 is fixed to the step surface 460 of the pressure boss member 450, and the lower end portion of the puncture spring 214 is fixed to the spring support portion 271 of the puncture rod 218. Thereby, as described later, the puncture rod 218 is urged downward by pressing the pressure boss member 450 from above.
  • the lock lever 462 has substantially the same structure as the lock lever (324) according to the third embodiment, except that the wall 336c facing the left and right in the peripheral wall 334 has an upper part.
  • the holding portion 464 is provided on the inner surface of the upper end of the holding portion 464 so as to protrude toward the inner peripheral side.
  • the lower end surface of the locking projection 466 is an inclined curved surface 468 (see FIG. 38) in which the vertical dimension of the locking projection 466 decreases toward the front.
  • the puncture button 322 and the cylinder lock 352 in this embodiment have substantially the same structure as in the above-described embodiment.
  • the engaging claws 366 project upward from each of the pair of left and right walls 356c of the peripheral wall 354, and when the cylinder lock 352 is assembled to the housing 442, for example, The inner housing 446 is adapted to be engaged.
  • the puncture button 322, the lock lever 462, and the cylinder lock 352 are assembled to the outer housing 444 via the puncture button spring 386 and the lock spring 388.
  • the inner housing 446, the pressure boss member 450, the pressing springs 318, 318, the movable cylinder 290, the puncturing spring 214, and the puncturing rod 218 are assembled, and the cap 392 and the cover 394 are assembled as necessary.
  • An applicator 440 according to the present embodiment is configured.
  • the locking projection 466 protruding inward from the holding portion 464 of the lock lever 462, It projects into the inside of the inside housing 446 through a notch 256 provided in the wall portion 250 c constituting the inside housing 446, and inside the inside of the inside housing 446, the flange-shaped portion 454 of the pressure boss member 450 engages with the lock lever 462.
  • the locking projection 466 abuts in the vertical direction and is locked.
  • the pressurizing boss member 450 is pressed by the mutual contact between the flange-shaped portion 454 and the locking projection 466. Downward movement is blocked. That is, in the present embodiment, the operation lock mechanism 470 for preventing the operation (movement) of the pressure boss member 450, which is an additional external force operation member described later, is configured to include the flange portion 454 and the locking protrusion 466. I have.
  • the puncture operation of the microneedle 216 is realized as shown in FIGS. That is, when the puncture button 322 is pressed, the lock lever 462 is pushed backward while the puncture button spring 386 is compressed and deformed, and the puncture rod 218 in the locking portion 342 of the lock lever 462 is inserted into the through window 268. Is released, the puncture rod 218 moves downward according to the urging force of the puncture spring 214, and the microneedle 216 pierces the skin.
  • the lock lever 462 moves rearward as described above, the locking projection 466 of the lock lever 462 enters the opening groove 456 provided in the flange-like portion 454 of the pressure boss member 450, and the flange-like portion 454 is formed. Is released. Therefore, in the present embodiment, the operation lock mechanism 470 that prevents the operation (movement) of the pressure boss member 450 can be released with the pressing operation of the puncture button 322.
  • the pressing boss member 450 can be pushed downward (inside the housing 442).
  • the puncture spring 214 is compressed between the pressure boss member 450 and the puncture rod 218, and the puncture rod 218 is pressed downward by its elastic restoring force, so that the microneedle 216 punctures the skin more reliably. Is done. That is, after the microneedle 216 pierces the skin, by pressing the pressure boss member 450 downward, an additional external force is buffered and continuously supplied to the microneedle 216 via the puncture spring 214 as the buffer means. In this embodiment, the same effects as in the third embodiment can be exerted.
  • the additional external force is applied by an external operation
  • the additional external force operation member that applies the external external force includes the pressure boss member 450.
  • the buffering external force applying mechanism for applying a buffering external force includes a pressure boss member 450 as an additional external force operating member.
  • the additional external force is applied to the microneedle 216 only while the pressing boss member 450 is pressed downward, so that the microneedle 216 is pressed against the skin. That is, the user can easily adjust the time during which an external force is additionally applied to the microneedle 216 according to the medicine to be used.
  • FIG. 42 shows a microneedle applicator (hereinafter, applicator) 480 as a fifth embodiment of the present invention in a storage state before use.
  • applicator compared with the applicators (210, 440) of the third and fourth embodiments, an additional external force is applied to the punctured microneedle 216 to press the microneedle 216 against the skin.
  • the mechanism is different. That is, the mechanism for attaching the case 410 holding the microneedle 216 to the applicator 480 and puncturing the microneedle 216 into the skin is substantially the same as that in the third or fourth embodiment.
  • Members and portions substantially the same as those of the embodiment are denoted by the same reference numerals in the drawings as those of the embodiment, and detailed description thereof will be omitted.
  • a substantially circular recess 484 that opens upward is formed in the center of the upper bottom wall 224 of the outer housing 482 in the present embodiment, and the center of the bottom wall in the circular recess 484 is formed. Is formed with a through hole 228.
  • the lid 240 of the inner housing 486 is inserted and fixed in the through hole 228, whereby the outer housing 482 and the inner housing 486 are fixed to each other, and the housing 488 of the present embodiment is configured.
  • a pressure boss hole 448 that penetrates in the up-down direction is formed in the central portion of the lid 240.
  • a pressure boss member 490 as an additional external force operation member is inserted into the inner housing 486 from above.
  • the pressing boss member 490 of the present embodiment includes a rod-shaped portion 492 extending in the vertical direction, and has a step-shaped portion 494 at an intermediate portion of the rod-shaped portion 492 in the vertical direction.
  • the upper part is larger in diameter than the lower part.
  • a substantially circular pressing operation portion 496 extending to the outer peripheral side is provided at an upper end portion of the rod-shaped portion 492, and an engaging portion 498 protruding to the outer peripheral side is provided at a lower end portion of the rod-shaped portion 492. Is provided.
  • the upper surface 496a of the pressing operation portion 496 is an operation surface that is directly operated from the outside when an external force is applied to the microneedle 216, as described later.
  • the puncture rod 500 is inserted into the inner housing 486 from below.
  • the puncture rod 500 includes a cylindrical portion 260 and a bottom wall portion 262 as in the third and fourth embodiments, but a central portion of the bottom wall portion 262 substantially protrudes into the cylindrical portion 260.
  • a cylindrical spring support portion 502 is provided, and an engagement claw 504 protruding inward is provided at an upper end portion of the spring support portion 502.
  • the rod-shaped portion 492 of the pressure boss member 490 having the above-described structure is inserted from above into the inner housing 486 and extends downward, and the pressing operation portion 496 of the pressure boss member 490 is moved outward. It is located in a circular recess 484 of the housing 482.
  • cylindrical portion 260 of puncturing rod 500 is located on the outer peripheral side of pressurizing boss member 490 and the lower end of rod-shaped portion 492.
  • the part is inserted into the spring support part 502 of the puncture rod 500, and the engaging part 498 and the engaging claw part 504 are engaged.
  • the pressure boss member 490 and the puncture rod 500 are relatively unmovable in the vertical direction while being unable to be pulled out.
  • the puncture spring 214 is disposed in a state of being inserted outside the rod-shaped portion 492 of the pressure boss member 490, and the upper end portion of the puncture spring 214 is attached to the lid of the inner housing 486.
  • the puncture spring 214 is fixed to the inner surface of the bottom wall portion 262 by being inserted into the spring support portion 502 of the puncture rod 500 while being fixed to the inner surface of the puncture spring 214.
  • a pressure spring 506 as a buffering means is externally inserted in a portion of the rod-shaped portion 492 having a small diameter below the step-shaped portion 494, and an upper end portion of the pressure spring 506 is connected to the rod-shaped portion.
  • the lower end portion of the pressure spring 506 is fixed to the spring supporting portion 502 of the puncture rod 500 while being fixed to the step-shaped portion 494 at 492.
  • a puncture button 322, a lock lever 324, and a cylinder lock 352 are attached to a housing 488 composed of an outer housing 482 and an inner housing 486 by a puncture button spring 386 and a lock. It is assembled via a spring 388. Further, a pressure boss member 490 and a puncture rod 500 are attached to the housing 488 from above and below via a puncture spring 214 and a pressure spring 506, and the movable cylinder 290 is provided with a pressing spring 318, It is assembled from below through 318.
  • the puncturing spring 214 and the pressure spring 506 have a substantially natural length, and the lower end portion of the puncturing rod 500 projects from the housing 488 and is located in the movable cylinder 290. are doing.
  • the pressing operation portion 496 located at the upper end of the pressure boss member 490 is in contact with the bottom surface of the circular concave portion 484 in the outer housing 482, and
  • the upper surface 496a of the pressing operation portion 496 which is an operation surface, is set at a position where it enters into the inside from the surface of the housing 488 (for example, the upper end surface of the upper bottom wall portion 224 of the outer housing 482).
  • the cap 392 that covers the lower end portion of the puncture rod 500 protruding from the housing 488 is assembled to the movable cylinder 290, and the cover 394 that covers the movable cylinder 290 and the cap 392 is attached to the housing 488 (outside). It is assembled so as to close the lower opening of the housing 482).
  • the puncture rod 500 is pushed (upward) into the housing 488. .
  • the puncture spring 214 is compressed, and the engaging portion 342 of the lock lever 324 is engaged with the through window 268 of the puncture rod 500.
  • the pressure boss member 490 is located above the puncture rod 500 via the pressure spring 506, the pressure boss member 490 is also moved upward along with the upward movement of the puncture rod 500.
  • the movable cylinder 290 By pushing the puncture rod 500 into the housing 488 in this manner, the movable cylinder 290 is allowed to move (upward) into the housing 488. In this state, by attaching the microneedle 216 (case 410) to the movable cylinder 290 and pressing the puncture button 322, as shown in FIG. 500 moves downward and microneedle 216 is punctured into the skin. The puncture rod 500 and the pressure boss member 490 are engaged with each other by the engagement claw portion 504 and the engagement portion 498. With the downward movement of the puncture rod 500, the pressure boss member 490 is also moved downward.
  • the pressing operation portion 496 of the pressure boss member 490 enters the circular recess 484, and the lower surface of the pressing operation portion 496 moves with respect to the bottom surface of the circular recess 484. Are opposed in the vertical direction at a predetermined distance from each other.
  • the upper surface (operation surface) 496a of the pressing operation portion 496 is directly pushed by a finger to puncture the step-shaped portion 494 of the pressure boss member 490.
  • the pressure spring 506 located between the rod 500 and the spring support 502 is compressed.
  • the puncture rod 500 is pressed downward by the elastic restoring action of the pressure spring 506, and the punctured microneedle 216 is further pressed against the skin.
  • transdermal drug administration by the microneedle 216 is more reliably achieved.
  • the additional external force to the microneedle 216 is exerted in a damping manner via the pressure spring 506 as the damping means, the patient may be less likely to feel pain. Further, while the pressing operation is performed on the pressure boss member 490, an additional external force is continuously applied to the microneedle 216. Therefore, the third embodiment is also applied to the applicator 480 of the present embodiment. The same effect as the embodiment can be exerted.
  • the additional external force operation member that exerts an additional external force by an external operation is configured by the pressure boss member 490, and includes the additional external force operation member (the pressure boss member 490).
  • a buffering external force applying mechanism that applies a buffering external force is configured.
  • the urging means for urging the microneedle 216 (the puncture rod 218) downward by being compressed is constituted by the puncture spring 214, and applies an additional external force to the microneedle 216.
  • the buffer means exerting a cushioning effect is constituted by the pressure spring 506, that is, the urging means and the buffer means are constituted by mutually different members.
  • the spring force (spring constant) of the urging means (puncturing spring 214) and the spring force (spring constant) of the buffer means (pressure spring 506) can be set separately, and the design of the applicator 480 can be made. The degree of freedom can be improved.
  • the operation surface (pressing operation The upper surface 496a) of the portion 496 is set at a position where the upper surface 496a enters the inside of the surface of the housing 488 (upper surface of the outer housing 482). Therefore, the possibility that the pressure boss member 490, which is an additional external force operation member, is unintentionally pressed not only in the storage state of the applicator 480 but also in the puncture state of the microneedle 216 can be reduced.
  • the operation lock mechanism (470) as in the fourth embodiment is not provided, but such an operation lock mechanism is provided to provide an additional external force operation member (pressing boss) before the puncture button is pressed. Operation of the member may be prevented.
  • FIG. 47 shows a microneedle applicator 510 according to a sixth embodiment of the present invention.
  • FIG. 47 is a perspective view showing the overall appearance of the microneedle applicator 510 according to the sixth embodiment.
  • FIG. 48 is an exploded perspective view of the microneedle applicator 510.
  • the microneedle applicator 510 is a device that applies a microneedle to the skin, and presses a patch having the microneedle against a target site such as the epidermis of the skin, and punctures the microneedle into the epidermis of the skin, thereby dispensing the drug solution into the body. Or a device for collecting a sample such as blood.
  • the microneedle applicator 510 mainly includes a main body 512 and a cover 514.
  • the main body 512 has a substantially octagonal cross section, is closed at the top of the upper end side, and is a bottomed cylindrical member 516 opened at the lower end side, and is housed in the housing 516. And a plurality of members.
  • the cover 514 is a bottomed cylindrical member having a substantially octagonal cross section, an open upper end, and a closed lower end.
  • the inside of the cover 514 is a substantially octagonal hollow portion conforming to the outer shape of the lower end of the housing 516, and is formed so that the lower end of the housing 516 fits.
  • the vertical direction in the description refers to the vertical direction on the drawing, and does not always match the actual vertical direction. As described later, when the microneedle applicator 510 is used, the top of the housing 516 may be turned down and the top and bottom may be reversed.
  • Puncturing rod 518 which is a member that collides with a patch 574 having a microneedle described later from the back side and presses the patch 574 against the skin, is slidably disposed.
  • Puncturing rod 518 is a bottomed cylindrical member that is open at the upper end and closed at the lower end.
  • the puncture rod 518 is housed in the hollow inside of a bottomed cylindrical puncture case 520 having an upper end closed and an open lower end.
  • the upper end portion of puncturing case 520 is fitted and fixed to a positioning portion provided on the inner surface of the upper end portion of housing 516. Puncture spring 522 is mounted between puncture rod 518 and puncture case 520.
  • the puncture spring 522 is housed in the hollow interior of the puncture rod 518, the upper end of the puncture spring 522 is supported by a support provided at the upper end of the hollow interior of the puncture case 520, and the lower end of the puncture spring 522 is located in the hollow interior of the puncture rod 518. Are respectively supported by the support portions provided at the lower end portion.
  • the puncture spring 522 compressed by pushing the puncture rod 518 into the housing 516 biases the puncture rod 518 in a direction to project from the housing 516 (hereinafter, referred to as a “puncture direction”; a downward direction is shown in the figure). I do.
  • the patch 574 corresponds to the microneedle support
  • the puncture spring 522 corresponds to the biasing means.
  • the puncturing direction corresponds to the first direction.
  • the direction in which the puncture rod 518 is pushed in is opposite to the puncture direction, and corresponds to a second direction that is opposite to the first direction.
  • the bottomed cylindrical cap 524 is arranged at the bottom of the cover 514 so that the upper part is opened, and the hollow inside of the cap 524 is punctured.
  • the cover 514 is attached so as to cover the lower end of the rod 518.
  • the cap 524 can be used as an auxiliary tool for a user who has difficulty in pushing the puncture rod 518 with a finger at the time of use.
  • the cap 524 is disposed on the mounting surface so that the bottom surface faces upward. The puncture rod 518 can be pushed into the housing 516 by pressing the puncture rod 518 against the bottom surface of the.
  • buttons 526, a cylinder lock 528, a lock lever 530, and button springs 532a and 532b are provided inside the housing 516 on the outer diameter side of the puncture case 520.
  • the button 526 is a member serving as a trigger for firing the puncture rod 518.
  • the button 526 is attached so that the pressing portion 534 is exposed to the outside through an opening 536 provided on a side surface of the housing 516.
  • On the inner diameter side of the pressing portion 534 of the button 526 two protrusions 538, 538 protruding toward the inner diameter side are provided.
  • the protrusions 538, 538 are plate-like members having surfaces parallel to the vertical direction, and the end surface on the inner diameter side is formed such that the lower side is formed in a plane parallel to the vertical direction, and the upper side is formed in a plane cut out in the outer shape direction. Have been.
  • a flange 540 extending laterally in the pressing direction is provided at the inner end of the pressing portion 534 over the entire circumference of the pressing portion 534.
  • the protrusions 538, 538 are formed so as to protrude from the end face on the inner diameter side of the flange 540.
  • the cylinder lock 528 is a substantially rectangular frame-shaped member. When the puncture rod 518 is not pushed in, the cylinder lock 528 pushes the movable cylinder 544 when the upper ends of the press receiving portions 552 and 554 of the movable cylinder 544 described later come into contact with the regulating portions 542a and 542b. It is a member that restricts movement in the direction.
  • a button spring 532a is interposed between the outer surface of the cylinder lock 528 opposite to the button 526 and the inner surface of the housing 516, and biases the cylinder lock 528 toward the button 526.
  • the lock lever 530 is a substantially rectangular frame-shaped member disposed below the cylinder lock 528.
  • a button spring 532b is interposed between the outer surface of the lock lever 530 opposite to the button 526 and the inner surface of the housing 516, and biases the lock lever 530 toward the button 526.
  • the protrusions 538 and 538 of the button 526 are arranged so as to pass through the slits 546 a and 546 b of the lock lever 530, and the inner surface of the flange 540 of the button 526 is pressed against the pressed surface 548 of the cylinder lock 528. Are facing each other.
  • a movable cylinder 544 is further disposed inside the housing 516 on the outer diameter side of the puncture case 520.
  • the movable cylinder 544 is a tubular member having a substantially octagonal cross section.
  • the movable cylinder 544 has a plate-like base 550 extending upward on the inner diameter side and curved so as to be convex on the outer circumference side.
  • plate-shaped press receiving portions 552 and 554 having a surface orthogonal to the pressing direction of the button 526 extend.
  • the lower ends of the pressure receiving portions 552 and 554 are formed with inclined surfaces that are inclined in the opposite direction to the button 526.
  • Pressing springs 556a and 556b are interposed between the movable cylinder 544 and the housing 516, and bias the movable cylinder 544 in a direction away from the housing 516.
  • the movable cylinder 544 corresponds to the button restricting means.
  • the cover 514, the housing 516, the puncture rod 518, the puncture case 520, the cap 524, the button 526, the cylinder lock 528, and the lock lever 530 can be formed of, for example, a resin such as PET or a metal, but are not limited thereto.
  • FIGS. 49A to 49F show respective states when the main body 512 of the microneedle applicator 510 is used after the cover 514 is removed.
  • FIGS. 50A to 50C show cross sections of the main body 512 of the microneedle applicator 510 in the AA direction (see FIG. 52A).
  • FIG. 49A shows a state in which the main body 512 is supported so that the puncture rod 518 faces upward. It is desirable to stabilize the housing 516 by placing the top of the housing 516 on a surface or the like.
  • the puncture rod 518 is pushed in the direction of arrow A (the side opposite to the puncture direction with respect to the housing 516).
  • FIG. 50A shows the microneedle applicator 510 in a state where the puncture rod 518 is not pushed.
  • puncturing rod 518 is in the puncturing direction with respect to housing 516, and the position of puncturing rod 518 with respect to housing 516 in FIG. 50A corresponds to the first position.
  • an opening 558 is formed on the side wall of the puncture rod 518 opposite to the button 526.
  • the cylinder lock 528 and the lock lever 530 are urged toward the button 526 by the button springs 532a and 532b, respectively.
  • the hook portion 560 protruding from the inner surface of the cylinder lock 528 to the button 526 side from the inner surface of the wall opposite to the button 526, and the lock lever 530 from the inner surface of the opposite side to the button 526.
  • the hook portion 562 protruding toward the button 526 is located on the movement path of the puncture rod 518 in the pushing direction.
  • the upper ends of the press receiving portions 552 and 554 of the movable cylinder 544 are in contact with the restricting portions 542a and 542b of the cylinder lock 528 to restrict the movement in the pushing direction. .
  • the button 526 is pressed in this state, the protrusions 538, 538 of the button 526 abut against the opposing press receiving portions 552, 554, and the action of the button 526 on the lock lever 530 is regulated.
  • the position of the movable cylinder 544 at this time corresponds to the third position.
  • the case 566 in which the retainer 564 is stored is moved to the retainer support portions 568, 570 provided at the end of the movable cylinder 544 in the puncture direction.
  • the retainer 564 is provided with a flange 572 (see FIG. 50 (c)) projecting toward the inner diameter side at a position retracted from the opening in the puncture direction of the retainer 564 in the circumferential direction.
  • Reference numeral 574 holds the peripheral portion to the end surface of the flange portion 572 by a method such as bonding.
  • the retainer 564 is stored in the case 566 so that the user does not touch the microneedle.
  • FIG. 50B shows a state where the puncture rod 518 is pushed to a predetermined position against the urging force of the puncture spring 522.
  • the position where the puncture rod 518 is pushed into the housing 516 shown in FIG. 50B corresponds to the second position.
  • the hook portion 560 of the cylinder lock 528 interferes with the cylindrical wall portion of the puncture rod 518 and is excluded from the movement path in the pushing direction of the puncture rod 518, so that the cylinder lock 528 is on the opposite side of the button 526.
  • the restricting portions 542a and 542b are in contact with the inner peripheral surface of the lock lever 530, and when the cylinder lock 528 moves to the opposite side of the button 526, the restricting portions 542a and 542b of the cylinder lock 528 also move. It moves to the opposite side of the button 526 while contacting the inner peripheral surface. That is, the restricting portions 542a and 542b can function as a guide for preventing the cylinder lock 528 from moving in a direction different from the moving direction accompanying the pressing of the button 526.
  • the cylinder lock 528 is provided with pawls 578 and 580 extending from the main body 576 to the top of the housing 516, and the upper surface of the pawl 580 has two different colors. It has regions 582a and 582b. At a position corresponding to the region 582a or 582b, a window portion 584 (see FIG. 52A) through which the inside of the housing 516 can be seen is formed. At the position of the cylinder lock 528 when the puncture rod 518 is not pushed in, the region 582b is visible from the window 584, and at the position of the cylinder lock 528 when the puncture rod 518 is pushed down to the predetermined position, the window 584 is opened. The area 582a will be visible. If the region 582a is formed in red, the color seen from the window 584 changes to red, so that the user can visually recognize that the puncture rod 518 has been pushed into a predetermined position.
  • the housing 516 is supported in a state where the opening of the retainer 564 is in contact with the portion of the skin 588 where the patch 574 is to be applied. Then, the housing 516 is pressed in the direction of arrow C. Then, the movable cylinder 544 is pushed into the housing 516 as shown in FIG. As shown in FIG. 50C, when the movable cylinder 544 is pushed to a predetermined position, the end opposite to the puncturing direction comes into contact with the housing 516, whereby further movement is restricted.
  • the position of the movable cylinder 544 with respect to the housing 516 shown in FIG. 50 (c) corresponds to the fourth position.
  • the pressing receiving portions 552 and 554 facing the protrusions 538 and 538 of the button 526 are moved in the puncturing direction in the state shown in FIG. And move in the opposite direction.
  • the protrusions 538 and 538 of the button 526 have no members that restrict the pressing of the button 526, so that the pressing of the button 526 is allowed.
  • the button 526 is pressed in the direction of arrow D perpendicular to the puncturing direction in the state shown in FIG. 49 (f)
  • the protruding portions 538, 538 of the pressed button 526 are locked from the state shown in FIG. 50 (c).
  • the puncture rod 518 moves in the puncture direction, and the puncture rod 518 biased by the puncture spring 522 projects in the puncture direction.
  • the end surface 590 of the puncture rod 518 in the puncture direction collides with a surface of the patch 574 held by the holder 564 in a direction opposite to the puncture direction.
  • the patch 574 separates from the retainer 564 and is pressed against the skin 588, and the microneedle provided on the surface of the patch 574 in the puncture direction punctures the epidermis of the skin 588.
  • the button 526 is configured to be pressed in a direction orthogonal to the puncturing direction, but the direction is not limited to the orthogonal direction as long as the direction intersects the puncturing direction.
  • FIG. 52A is a diagram showing the main body 512 of the microneedle applicator 510 in the AA direction as viewed from the top of the head, and FIG. 52 (c) and 52 (d) are enlarged views of the part circled in FIG. 52 (b).
  • FIG. 52 (b) shows a state in which the main body 512 of the microneedle applicator 510 is cut along the AA plane passing through the center of the button 526 along the central axis of the housing 516 as shown in FIG. 52 (a).
  • the structure is shown.
  • FIG. 52 (c) is an enlarged view of a portion surrounded by a circle in FIG. 52 (b) when the button 526 is not pressed.
  • FIG. 52D is an enlarged view of a portion surrounded by a circle in FIG. 52B when the button 526 is pressed.
  • a wall portion 594 extending in the axial direction from the inner surface of the top of the housing 516 to the step portion 592 of the puncture case 520 is arranged on the inner diameter side of the base portion 550 of the movable cylinder 544.
  • the wall portion 594 is formed in a plate shape curved so as to protrude to the outer peripheral side similarly to the base portion 550 of the movable cylinder 544.
  • the wall portion 594 includes a surface 596 extending in the puncturing direction from the inner surface of the top of the housing 516, a step surface 598, and a surface 600 extending further in the puncturing direction from the inner diameter side of the step surface 598.
  • the surface 596 and the surface 600 of the wall portion 594 are located on the outer diameter side and the surface 600 is located on the inner diameter side via the step surface 598.
  • the step surface 598 is a surface substantially perpendicular to the puncturing direction, and extends in a circumferential direction about the axis (a front side and a rear side in a direction perpendicular to the paper surface in FIG. 52B).
  • the step surface 598 is formed at a position substantially corresponding to the upper end 550a of the base 550 of the movable cylinder 544 when the movable cylinder 544 shown in FIG. 52B is not pushed.
  • the width of the wall 594 in a direction perpendicular to the puncture direction (the direction perpendicular to the drawing in FIG. 52B) is equal to or smaller than the width of the base 550 in the same direction. Therefore, when the movable cylinder 544 is pushed in and the press receiving portions 552 and 554 move to positions not facing the protrusion 538 of the button 526, the protrusion 538 does not interfere with the wall portion 594 and the button 526 does not interfere. Is not hindered.
  • the inner side surface 550b of the base 550 of the movable cylinder 544 is located on the outer diameter side with respect to the surface 596 of the wall portion 594. . Therefore, when the movable cylinder 544 is pushed in without pressing the button 526, the upper end 550a of the base 550 does not interfere with the step surface 598. At this time, the side surface 550b on the inner diameter side of the base portion 550 of the movable cylinder 544 is separated from the outer diameter side of the surface 596 of the wall portion 594 by being separated from the surface 596 or sliding with the surface 596, in the opposite direction to the puncture direction. , The movable cylinder 544 can be pushed.
  • the step surface 598 corresponds to the movement restriction unit, the contact surface, and the slide prevention unit.
  • the pressing of the movable cylinder 544 is restricted, so that the user presses the button 526 while pressing the button 526. Sliding between the protrusions 538, 538 of the button 526 and the press receiving portions 552, 554 of the movable cylinder 544, which can be caused by pushing the movable cylinder 544, can be prevented. Therefore, the projections 538 and 538 of the button 526 and the press receiving portions 552 and 554 of the movable cylinder 544 do not wear while the safety is secured, and the button 526, the movable cylinder 544, and other members are not deformed. Thus, the smooth operation of the microneedle applicator 510 is enabled.
  • FIG. 53 shows a main body 604 of a microneedle applicator 602 as a seventh embodiment of the present invention.
  • FIG. 53 is a perspective view showing the appearance of the main body 604 of the microneedle applicator 602 with the retainer 564 attached.
  • the cover 606 is provided on the microneedle applicator 602 outside the pressing portion 534 of the button 526.
  • the cover 606 has a plate-shaped main portion 608 having an area covering the entire surface of the pressing portion 534 of the button 526.
  • connection portions 610 and 610 that are bent toward the housing 516 at positions beyond the opening 536 are provided.
  • Legs 612, 612 extend in the puncture direction from the edge of the connection portions 610, 610 on the housing 516 side. The ends of the legs 612 and 612 in the puncturing direction are connected by a connecting portion 614 extending in a direction perpendicular to the puncturing direction.
  • An opening 616 adjacent to the main portion 608 in the puncturing direction is formed by the main portion 608, the legs 612, 612, and the connecting portion 614 in the cover 606.
  • An engaging portion 618 is provided at the center of the connecting portion 614 in a direction orthogonal to the puncturing direction, and extends to the inner diameter side.
  • a slit 620 that penetrates from the inside of the housing 516 to the outside is formed below the opening 536 of the housing 516 in the puncturing direction.
  • the engaging portion 618 of the cover 606 extends to the inside of the housing 516 via the slit 620, and engages with the supporting portion 622 of the movable cylinder 544.
  • flange portions 624, 624 are provided, which protrude in the direction perpendicular to the puncturing direction, from the connecting portions 610, 610 to the legs 612, 612, respectively. ing.
  • Guides 626 and 628 extending in the axial direction are provided on both sides of the opening 536 of the housing 516 in the direction perpendicular to the axis. Grooves 626a and 628a are provided along the axial direction on the side surface of the guides 626 and 628 on the opening 536 side.
  • the flange portions 624 and 624 of the cover 606 engage with the grooves 626a and 628a, respectively. As described later, when the movable cylinder 544 moves in the direction opposite to the puncturing direction, the flange portions 624 and 624 engage with the grooves 626a and 628a and are guided by the guides 626 and 628.
  • the engaging portion 618 of the cover 606 is engaged with the support portion 622 of the movable cylinder 544, and moves in the direction opposite to the puncturing direction in conjunction with the movable cylinder 544. .
  • the main part 608 of the cover 606 moves in a direction opposite to the puncturing direction from outside the pressing part 534 of the button 526. Accordingly, the portion of the pressing portion 534 of the button 526 that is covered by the main portion 608 decreases, and the portion exposed from the opening 616 increases.
  • the entire surface of the pressing portion 534 of the button 526 is exposed from the opening 616.
  • FIG. 54 (a) is a view of the microneedle applicator 602 viewed from the top of the housing 516.
  • FIG. 54B is a BB cross-sectional view of the main body 512 of the microneedle applicator 602 to which the retainer 564 is attached.
  • FIG. 55 is a perspective view showing the appearance of the main body 604 of the microneedle applicator 602 in a state where the retainer 564 is mounted and the movable cylinder 544 is pushed to a predetermined position.
  • FIG. 56 is a BB cross-sectional view of the microneedle applicator 602 in a state where the retainer 564 is mounted and the movable cylinder 544 is pushed into a predetermined position.
  • the cover 606 linked to the movable cylinder 544 also moves in the direction opposite to the puncturing direction.
  • the main portion 608 of the cover 606 is located in the direction opposite to the puncturing direction of the pressing portion 534 of the button 526, and the connecting portion 614 is puncturing direction of the pressing portion 534 of the button 526.
  • the entire surface of the pressing portion 534 is exposed from the opening 616.
  • the cover 606 corresponds to a sliding prevention unit.
  • the user can press the button 526 by moving the main portion 608 of the cover 606 from the position covering the pressing portion 534 of the button 526 to the position opposite to the puncturing direction. That is, at the stage where the movable cylinder 544 is pushed to the predetermined position, the user cannot press the button 526. Therefore, it is possible to prevent the protrusions 538, 538 of the button 526 from sliding by the press receiving portions 552, 554 of the movable cylinder 544, which can be caused by pushing the movable cylinder 544 while pressing the button 526.
  • the projections 538 and 538 of the button 526 and the press receiving portions 552 and 554 of the movable cylinder 544 may be worn while the safety is ensured, and the button 526, the movable cylinder 544 and other members may be deformed.
  • the smooth operation of the microneedle applicator 602 is enabled.
  • a solid needle is adopted as the microneedles 12 and 216, and the medicine to be administered to the solid needle is applied.
  • the present invention is not limited to this mode.
  • a hollow needle having a lumen a structure in which a drug is administered through a lumen of a hollow needle punctured from a reservoir that separately holds a drug, and the like can be adopted.
  • the shape, structure and number of the puncture needles are not limited.
  • the microneedles may be used not only for administration (transport) of a drug but also for blood collection and the like.
  • the mechanism for restricting the movement by abutting the movable cylinders 72, 290, 544 before pushing the puncture rods 14, 218, 518 into the housings 16, 212, 442, 488, 516 includes the cylinder locks 130, 352 illustrated. , 528, and various types of releasable locking structures, such as a rotatable hook and engagement using a magnetic force, can be appropriately adopted.
  • the urging of the puncture rod, the movable cylinder, the lock lever, the lock member (cylinder lock), the puncture button (button), the pressure rod, and the pressure button is not limited to the spring as in the above embodiment, It may be achieved by a magnet or the like in addition to an elastic body such as rubber or an elastomer. That is, for example, a spring may be employed as the urging means, and an elastic body other than the spring may be employed as the buffering means in the third to fifth embodiments. An elastic body may be employed, and a spring may be employed as a buffer.
  • the covers 152, 394, and 514 are substantially cup-shaped, and cover the puncture rods 14, 218, 518 and the movable cylinders 72, 290, 544 in the storage state.
  • the view may be substantially annular, and may cover at least a part of the movable cylinder. However, such a cover is not essential.
  • the puncture spring 214 and the pressure spring 288 are arranged in series in the vertical direction with the pressure rod 272 interposed therebetween, and in the fifth embodiment, the puncture spring 214
  • the pressurizing springs 506 are arranged in parallel on the inner peripheral side, but are not limited to such an embodiment. That is, when the puncture spring and the pressure spring are arranged in series as in the third embodiment, the restoring force of the pressure spring may be applied to the puncture spring via the pressure rod, The puncture spring and the pressure spring need not necessarily be arranged in the vertical direction.
  • the puncture spring and the pressure spring are arranged in parallel as in the fifth embodiment, the lower end of the puncture spring and the lower end of the pressure spring are fixed to the puncture rod, and It is only necessary that the pressure springs operate independently of each other, and it is not necessary to dispose the pressure springs in an internal / external state.
PCT/JP2019/033987 2018-08-30 2019-08-29 マイクロニードルアプリケータ WO2020045588A1 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201980056800.6A CN112888474A (zh) 2018-08-30 2019-08-29 微针敷贴器
KR1020217005842A KR20210086599A (ko) 2018-08-30 2019-08-29 마이크로 니들 어플리케이터

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
JP2018161450A JP7448306B2 (ja) 2018-08-30 2018-08-30 マイクロニードルアプリケータ
JP2018-161449 2018-08-30
JP2018-161450 2018-08-30
JP2018-161323 2018-08-30
JP2018161323A JP7099189B2 (ja) 2018-08-30 2018-08-30 マイクロニードルアプリケータ
JP2018161449A JP7172293B2 (ja) 2018-08-30 2018-08-30 マイクロニードルアプリケータ

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004510530A (ja) * 2000-10-13 2004-04-08 アルザ・コーポレーシヨン マイクロブレードアレー衝撃アプリケータ。
JP2007509706A (ja) * 2003-10-31 2007-04-19 アルザ・コーポレーシヨン 微小突起列のための自己−作動性アプリケーター
JP2008534152A (ja) * 2005-03-28 2008-08-28 アルザ コーポレイション 微小突起で皮膚を穿刺する装置及び方法
WO2013051568A1 (ja) * 2011-10-06 2013-04-11 久光製薬株式会社 アプリケータ
WO2017038499A1 (ja) * 2015-09-02 2017-03-09 久光製薬株式会社 アプリケータ

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004510530A (ja) * 2000-10-13 2004-04-08 アルザ・コーポレーシヨン マイクロブレードアレー衝撃アプリケータ。
JP2007509706A (ja) * 2003-10-31 2007-04-19 アルザ・コーポレーシヨン 微小突起列のための自己−作動性アプリケーター
JP2008534152A (ja) * 2005-03-28 2008-08-28 アルザ コーポレイション 微小突起で皮膚を穿刺する装置及び方法
WO2013051568A1 (ja) * 2011-10-06 2013-04-11 久光製薬株式会社 アプリケータ
WO2017038499A1 (ja) * 2015-09-02 2017-03-09 久光製薬株式会社 アプリケータ

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KR20210086599A (ko) 2021-07-08

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