JP5954011B2 - Microneedle penetration control device - Google Patents

Description

  The present invention relates to a microneedle penetration control device for a fluid injector that uses a multi-microneedle device.

  Fluid injectors using multi-microneedle devices are known, for example, in the medical field. Such fluid injectors in the medical field are known as syringes.

  The fluid injector includes an elongated fluid holding space capable of holding a predetermined amount of fluid (for example, a medical solution in the medical field) and a fluid outlet that is disposed at one end in the longitudinal direction of the fluid holding space and from which the fluid can flow out. And a fluid holding cylinder (injection cylinder in the case of a syringe) having a fluid holding space inlet opening disposed at the other end in the longitudinal direction of the fluid holding space, and the longitudinal direction from the fluid holding space inlet opening to the fluid holding space of the fluid holding cylinder A piston member slidably combined along the direction center line.

  In the medical field, a multi-microneedle device can be used for intradermal injection attached to a fluid outlet of a syringe barrel of a conventional syringe, instead of a single injection needle well known in the medical field. It is being considered. The multi-microneedle device is formed from the fluid outlet of the syringe barrel to the outlet outlet by pressing the piston member of the syringe and the outlet outlet attached to the fluid outlet of the fluid of the syringe barrel, the drug solution in the medical field. A flat main body in which a flat fluid holding space for temporarily holding out the fluid that has flowed out is formed, and a plane that is located on the opposite side of the flat body with the outflow port attachment port across the fluid holding space And a plurality of microneedles arranged on the top.

  The flat surface of the flat body functions as a skin contact surface, and each of the plurality of microneedles has a minute fluid injection path extending between a proximal end on the flat surface and a distal end away from the flat surface. The length between the proximal end and the distal end, that is, the height of each microneedle is a range of the thickness of the skin tissue of an organism (for example, all humans) having the skin tissue to be used. It is set to enter.

Special table 2006-518675 gazette JP-T-2004-507371 Japanese translation of PCT publication No. 2003-501161 JP-T-2002-521222

  When intradermal injection is performed by a syringe using a multi-microneedle device, a fluid used for intradermal injection, for example, a drug solution, is previously taken into the syringe barrel through the fluid outlet of the syringe barrel, and thereafter The outlet of the multi-microneedle device is detachably attached to the fluid outlet of the syringe barrel, and then the piston member of the syringe is pushed slightly to further reduce the fluid holding space of the multi-microneedle device and the micro-needles of the plurality of microneedles. The air in the fluid injection path is pushed out to the external space by the fluid from the syringe barrel, and the fluid holding space of the multi-microneedle device and the minute fluid injection paths of the plurality of microneedles are filled with the fluid.

  Next, the skin contact surface of the body of the multi-microneedle device is pressed against the desired exposed part of the skin of a living organism, such as a person. By this pressing, the plurality of microneedles on the skin contact surface is pierced into the skin tissue of a desired portion where the skin of an organism, for example, a person, is exposed. Then, when the piston of the syringe is pushed, the fluid from the syringe barrel is exposed to the skin of a living organism such as a human through the fluid holding space of the multi-microneedle device and the microfluidic injection paths of the plurality of microneedles. It is injected into the skin tissue at the desired location.

  In the case of performing intradermal injection with a syringe using a multi-microneedle device, the syringe while the skin contact surface of the body of the multi-microneedle device is pressed against a desired part of the skin of a living organism such as a person The piston member is pushed. In this case, at the desired exposed portion of the skin, a force for pushing the piston of the syringe is applied in addition to the pressure from the skin contact surface of the body of the multi-microneedle device, and the desired exposed portion of the skin. The skin tissue is compressed and loses some elasticity. This means that when performing intradermal injection with a syringe using a multi-microneedle device, it is not possible to inject all of the fluids from a plurality of microneedles, for example, drug solutions, into the skin tissue at the desired location. The fluid has leaked to the surface of the skin at the desired location, or it has taken a relatively long time to inject all of the desired amount of fluid into the skin tissue at the desired location.

  The present invention has been made under the circumstances described above, and the object of the present invention is to use a multi-microneedle device, for example, when an intradermal injection is made into a skin tissue at a desired location by a fluid injector such as a syringe. However, an object of the present invention is to provide a microneedle penetration amount regulating device capable of easily and reliably injecting all of a desired amount of fluid in a fluid infusing device into skin tissue at a desired location.

In order to achieve the above-described object of the present invention, a microneedle penetration amount regulating device according to the present invention is a microneedle penetration amount regulating device for a fluid injector using a multi-microneedle device. :
A proximal end fixed away from the multi-microneedle device along the longitudinal direction of the fluid retaining cylinder with respect to the fluid retaining cylinder of the fluid injector;
Elasticity extending from the base end to the skin contact surface of the main body of the multi-microneedle device along the outer peripheral surface of the fluid holding cylinder, and moving away from the outer peripheral surface of the fluid holding cylinder as the extension distance from the base end increases One part; and
The skin contact of the main body of the multi-microneedle device is provided at the extending end of the elastic piece and has a predetermined thickness smaller than the protruding height of the plurality of microneedles from the skin contact surface of the main body of the multi-microneedle device. A microneedle insertion amount regulating portion arranged by an elastic force of an elastic piece at an initial position moved from the surface toward the side of the main body and toward the base end;
With
A plurality of microneedles on the skin contact surface of the main body of the multi-microneedle device from the initial position by the elastic piece being pushed toward the outer peripheral surface of the fluid holding cylinder against the elastic force, Move to the operating position corresponding to the area surrounding
It is characterized by that.

A microneedle penetration control device for a fluid injector using a multi-microneedle device according to the present invention, characterized in that it is configured as follows: A proximal end fixed away from the multi-microneedle device along the longitudinal direction of the holding cylinder; extending from the proximal end along the outer peripheral surface of the fluid-holding cylinder toward the skin contact surface of the body of the multi-microneedle device; An elastic piece portion that moves away from the outer peripheral surface of the fluid holding cylinder as the extension distance from the end portion increases; A predetermined thickness smaller than the protruding height of the plurality of microneedles, and the side of the body from the skin contact surface of the body of the multi-microneedle device A microneedle penetration inclusive amount restricting portion arranged by the elastic force of the elastic piece portion to the initial position moved towards the fine said proximal portion,
It has.

  While the elastic piece is not pressed and the microneedle insertion amount restricting portion is located at the initial position, the skin contact surface of the main body of the multi-microneedle device is sufficiently placed at the desired position where the biological skin is exposed. In addition to being able to press, a plurality of microneedles on the skin contact surface can be sufficiently inserted into the skin tissue at the desired position.

  However, at this time, the force with which the skin contact surface of the main body of the multi-microneedle device presses the desired position where the skin of the organism is exposed reduces the elasticity of the desired position where the skin is exposed.

  As described above, the skin contact surface of the main body of the multi-microneedle device is sufficiently pressed to the desired position where the skin of the living body is exposed, and the plurality of microneedles on the skin contact surface are the skin at the desired position. When the elastic piece portion is pushed toward the outer peripheral surface of the fluid holding cylinder against the elastic force while it is fully inserted into the tissue, the microneedle insertion amount regulating portion is moved from the initial position to the multi-microneedle. Move to an operating position corresponding to the area surrounding the plurality of microneedles on the skin contacting surface of the body of the device.

  This movement of the microneedle puncture amount restricting portion is performed by exposing the region surrounded by the microneedle puncture amount restricting portion on the skin contact surface of the main body of the multi-microneedle device and having a plurality of microneedles. The force for pressing the desired position can be reduced. That is, the elasticity of the skin tissue at a desired position where the skin is exposed is restored.

  Thereafter, when the fluid is discharged from the fluid injector through the plurality of microneedles of the multi-microneedle device, the fluid discharged from the plurality of microneedles is in the skin tissue at a desired position where the biological skin is exposed. Can be injected quickly.

  The elastic piece portion is pushed against the elastic force against the outer peripheral surface of the fluid holding cylinder, and the microneedle insertion amount regulating portion is surrounded from the initial position on the skin contact surface of the main body of the multi-microneedle device. Anyone can easily and reliably perform the movement to the operation position corresponding to the region.

  Therefore, the multi-microneedle device is used by using the microneedle insertion amount regulating device for the fluid injector using the multi-microneedle device according to the present invention, which is characterized in this way. Thus, for example, when an intradermal injection is made into the skin tissue at a desired location with a fluid infuser, such as a syringe, anyone can easily and reliably obtain all of the desired amount of fluid in the fluid infuser in a short time. Can be injected into the skin tissue.

FIG. 1A is a schematic side view of a fluid infuser combined with a microneedle penetration control device and using a multi-microneedle device according to one embodiment of the present invention, In FIG. 1, the pair of elastic pieces of the microneedle insertion amount regulating device is not pressed against the elastic force, and the microneedle insertion amount regulating unit is disposed at the initial position; FIG. 1 is a schematic back view of a microneedle insertion amount regulating portion at an initial position of an extension end of a pair of elastic pieces of the microneedle penetration amount regulating device of FIG. (C) of FIG. 1 is a schematic side view of the fluid injector of FIG. 1 (A). Here, the elastic piece of the microneedle insertion amount regulating device is pressed against its elastic force. Microni The dollar piercing amount restricting portion has been moved from the initial position to the operating position; and FIG. 1D shows the pair of elastic pieces of the microneedle piercing amount restricting device of FIG. It is a schematic back view of the microneedle penetration amount regulation part of the operation position of an extension end. FIG. 2A is a schematic side view of a fluid infuser combined with a microneedle penetration control device and using a multi-microneedle device according to another embodiment of the present invention, Here, the microneedle insertion amount regulating device includes a fluid injector holder that detachably holds the fluid injector, and further here, a pair of elastic pieces of the microneedle insertion amount regulating device Is not pressed against the elastic force, and the microneedle insertion amount restricting portion is disposed at the initial position; FIG. 2B is the microneedle insertion amount restriction of FIG. FIG. 2 is a schematic back view of a microneedle insertion amount regulating portion at an initial position of an extended end of a pair of elastic pieces of the instrument; FIG. 2C is a fluid injector of FIG. Holding body Here, the elastic piece portion of the microneedle penetration amount regulating device is pressed against the elastic force, and the microneedle penetration amount regulating portion is moved from the initial position to the operating position. 2D is a microneedle insertion amount restriction at the operating position of the extended end of the pair of elastic pieces of the microneedle insertion amount restriction device of FIG. 2C. It is a schematic back view of a part.

[One Embodiment]
First, referring to FIGS. 1A and 1B, a microneedle insertion restriction device 14 according to an embodiment of the present invention for a fluid injector 12 using a multi-microneedle device 10. The structure will be schematically described.

  It is considered that the fluid injector 12 using the multi-microneedle device 10 combined with the microneedle insertion amount regulating device 14 according to the embodiment of the present invention is used as a syringe in the medical field, for example.

  The fluid injector 12 is an elongated fluid holding space capable of holding a predetermined amount of fluid (for example, a medical solution in the medical field) and a fluid flow that is disposed at one end in the longitudinal direction of the fluid holding space and from which the fluid can flow out. A fluid holding cylinder 12b (an injection cylinder for a syringe) having an outlet 12a and a fluid holding space inlet opening disposed at the other end in the longitudinal direction of the fluid holding space, and a fluid holding space inlet into the fluid holding space of the fluid holding cylinder 12b A piston member 12c slidably combined along the longitudinal center line from the opening.

  In this embodiment, a fluid holding cylinder 12b (a syringe cylinder in a syringe) having a fluid outlet 12a and a fluid holding space inlet opening disposed at the other end in the longitudinal direction of the fluid holding space, a piston member 12c, The fluid injector 12 with a can be a combination of a syringe barrel and a piston member of a known syringe.

  In the medical field, the multi-microneedle device 10 can be used for intradermal injection attached to the outlet of a syringe barrel of a conventional syringe, instead of a single injection needle well known in the medical field. It is being considered.

  The multi-microneedle device 10 includes an outlet attachment port 10a and a fluid injector that are detachably attached to a fluid outlet 12a of fluid in a fluid holding cylinder 12b (injection cylinder in a syringe) of a fluid injector 12, or a medical solution in the medical field. A flat main body 10b formed with a flat fluid holding space for temporarily holding the fluid flowing out from the fluid outlet 12a of the fluid holding cylinder 12b to the outlet mounting port 10a by the pressing of the twelve piston members 12c; The flat main body 10b is provided with a plurality of microneedles 10c arranged on a plane located on the opposite side of the fluid holding space with respect to the outlet mounting port 10a.

  The multi-microneedle device 10 can be manufactured, for example, by applying an etching means using a known photolithography method to a silicon substrate. Furthermore, using the silicon multi-microneedle device as an original plate, it is also possible to produce a reversal-shaped duplicate plate by electroforming, and to produce a resin-made multi-microneedle device 10 from the duplicate plate.

  The plane of the flat main body 10b functions as a skin contact surface 10d, and each of the plurality of microneedles 10c extends between a proximal end on the plane and a distal end away from the plane. The length between the proximal end and the distal end, that is, the height of each microneedle 10c is the thickness of the skin tissue of an organism (for example, all humans) having the skin tissue to be used. It is set to fall within the thickness range. Specifically, the height of the microneedle 10c is preferably set within a range of 100 to 2000 μm. The shape of the microneedle 10c is appropriately selected from a cone shape such as a cone and a pyramid, and a columnar shape such as a cylinder and a prism.

  The microneedle insertion amount regulating device 14 according to the embodiment of the present invention is a base fixed to the fluid holding cylinder 12b of the fluid injector 12 apart from the multi-microneedle device 10 along the longitudinal direction of the fluid holding cylinder 12b. An end portion 14a is provided.

  The microneedle insertion amount regulating device 14 also extends from the base end portion 14a along the outer peripheral surface of the fluid holding cylinder 12b toward the skin contact surface 10d of the main body 10b of the multi-microneedle device 10, and extends from the base end portion 14a. As the distance increases, an elastic piece portion 14b that moves away from the outer peripheral surface of the fluid holding cylinder 12b is provided.

  The microneedle insertion amount regulating device 14 is further provided at the extending end of the elastic piece portion 14b, and has a predetermined height smaller than the protruding height of the plurality of microneedles 10c from the skin contact surface 10d of the main body 10b of the multi-microneedle device 10. A microneedle insertion amount restricting portion 14c having a thickness is provided.

  The microneedle insertion amount restricting portion 14c is arranged by the elastic force of the elastic piece portion 14b at the initial position moved from the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 to the side of the main body 10b and the base end portion 14a. Has been.

  Then, as shown in FIGS. 1C and 1D, the elastic piece portion 14b is pushed toward the outer peripheral surface of the fluid holding cylinder 12b against the elastic force, thereby inserting the microneedle. The restricting portion 14c moves from the initial position shown in FIG. 1A to an operating position corresponding to a region surrounding the plurality of microneedles 10c on the skin contact surface 10d of the main body 10b of the multi-microneedle device 10. .

  Next, referring to FIGS. 1A to 1D, the multi-microneedle device 10 is used in combination with the microneedle insertion amount regulating device 14 according to the embodiment of the present invention. A procedure for operating the fluid injector 12 to inject the fluid held by the fluid injector 12 into the skin tissue at a desired location on the skin of an organism, for example, a human in this embodiment, for example, a chemical solution. explain.

  A desired amount of a fluid, for example, a chemical solution, to be injected into the skin tissue of a living organism, for example, a person, is a fluid holding space in the fluid holding cylinder 12b and the main body 10a of the multi-microneedle device 10 and a plurality of micro The minute fluid injection path of the needle 10c is already filled.

  The user of the fluid injector 12 combined with the microneedle insertion amount regulating device 14 according to the embodiment of the present invention described above and using the multi-microneedle device 10 controls the microneedle insertion amount regulation. As shown in FIG. 1 (A), the microneedle insertion amount restricting portion 14c of the instrument 14 extends from the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 to the side and base end portions of the main body 10b. While being positioned by the elastic force of the elastic piece 14b at the initial position moved toward 14a, the outer surface of the fluid injector 12 is grasped, and then the skin SK of a living organism, for example, a person, is exposed. The skin contact surface 10d of the main body 10b of the multi-microneedle device 10 is pressed to the position.

  At this time, the plurality of microneedles 10c on the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 is reliably pierced into the skin tissue in the region (see FIG. 1A).

  Also, at this time, the elasticity of the skin tissue in the above-mentioned desired position where the skin SK to which the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 is pressed is exposed is somewhat lost.

  Next, the elastic piece 14b of the microneedle insertion amount regulating device 14 is pushed toward the outer peripheral surface of the fluid holding cylinder 12b against the elastic force, and is shown in FIGS. 1C and 1D. As described above, the microneedle insertion amount restricting portion 14c at the extending end of the elastic piece portion 14b is formed on the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 from the initial position shown in FIG. It moves to the operation position corresponding to the area | region surrounding the several microneedle 10c.

  The microneedle insertion amount regulating portion 14c at the extended end of the elastic piece portion 14b moved to the operating position is higher than the protruding height of the plurality of microneedles 10c from the skin contact surface 10d of the main body 10b of the multi-microneedle device 10. Since it has a small thickness, the microneedle insertion amount restricting portion 14c at the extending end of the elastic piece portion 14b moved to the operating position is provided with a plurality of micros from a desired position where the skin SK is exposed. The needle 10c is not pulled out.

  In addition, at the desired position where the skin SK is exposed, the elastic piece portion 14b moved to the operating position is moved to the region not pushed by the microneedle insertion amount restricting portion 14c, that is, to the operating position. In the region where the plurality of microneedles 10c protrude from the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 surrounded by the microneedle insertion amount regulating portion 14c at the extending end of the elastic piece portion 14b. The corresponding region expands toward the skin contact surface 10d as the elasticity is restored.

  During this time, the user presses the piston member 12c of the fluid injector 12 as indicated by an arrow P in FIG. As a result, the fluid filled in the fluid holding cylinder 12b of the fluid injector 12, the fluid holding space of the main body 10a of the multi-microneedle device 10, and the minute fluid injection paths of the many microneedles 10c as described above. As described above, the elasticity of the desired position where the skin SK is exposed is restored through the minute fluid injection paths of the multiple microneedles 10c of the multi-microneedle device 10 according to the pressing distance. As shown by a plurality of arrows I in FIG. 1C, it can be easily and quickly injected into the skin tissue in the above-mentioned region without leaking out of the skin SK.

  After the injection of the fluid from the fluid injector 12 into the skin tissue in the region at the desired position where the skin SK is exposed through the multiple microneedles 10c of the multi-microneedle device 10 is completed. The region at the desired position where the fluid injector 12 is pulled away from the desired position where the skin SK is exposed, and at the same time, the plurality of microneedles 10c of the multi-microneedle device 10 is exposed as the skin SK. Pulled from the skin tissue.

  Next, if the pressing force applied to the elastic piece portion 14b of the microneedle insertion amount regulating device 14 is released, the microneedle insertion amount regulating portion 14c at the extending end of the elastic piece portion 14b is shown in FIG. C) Return to the initial position shown in FIG. 1A from the operating position shown in FIG. 1 by the elastic force of the elastic piece 14b.

  In this embodiment, the microneedle insertion amount regulating device 14 surrounds the outer peripheral surface of the fluid holding cylinder 12b of the fluid injector 12 together with the base end portion 14a or the elastic piece portion 14b of the microneedle insertion amount regulating device 14. Further, an annular elastic piece operating member 16 that is movable along the longitudinal direction of the fluid holding cylinder 12b is further provided. Further, in this embodiment, the elastic piece portion 14b includes an elastic piece portion operating member that protrudes outward in the radial direction of the fluid holding cylinder 12b between the base end portion 14a and the extended end of the elastic piece portion 14b. A stopper 14d is provided. The elastic piece portion operation member retaining member 14d may be formed integrally with the elastic piece portion 14b, or may be formed separately from the elastic piece portion 14b and then fixed to the elastic piece portion 14b.

  In the microneedle insertion amount restricting device 14, the annular elastic piece portion operating member 16 has an initial position disposed on the base end portion 14a as shown in FIG. 1A, and FIG. It is possible to move along the longitudinal direction of the fluid holding cylinder 12b on the base end part 14a and the elastic piece part 14b between the operation position in contact with the elastic piece part operation member retaining member 14d as shown in FIG. .

  While the annular elastic piece portion operating member 16 is disposed at the initial position on the base end portion 14a as shown in FIG. 1A, the elastic piece portion 14b retains fluid by its elastic force. The microneedle insertion amount restricting portion 14c at the extended end of the elastic piece portion 14b is disposed at the initial position away from the outer peripheral surface of the tube 12b.

  When the annular elastic piece operating member 16 is moved from the initial position on the base end portion 14a shown in FIG. 1A toward the extending end of the elastic piece portion 14b, the elastic piece portion 14b. 1 is pushed toward the outer peripheral surface of the fluid holding cylinder 12b against the elastic force, and the microneedle insertion amount restricting portion 14c at the extending end of the elastic piece portion 14b is shown in FIG. 1C from the initial position. Can be moved to the operating position.

  The annular elastic piece portion operating member 16 moved toward the extending end of the elastic piece portion 14b along the outer peripheral surface of the fluid holding cylinder 12b on the elastic piece portion 14b is disconnected from the elastic piece portion operating member on the elastic piece portion 14b. By coming into contact with the stopper 14d, the elastic piece portion 14b is prevented from falling off from the extended end.

  When the annular elastic piece operation member 16 is moved from the elastic piece portion 14b toward the initial position as shown in FIG. 1A on the base end portion 14a and reaches the initial position, the elastic piece The portion 14b is allowed to move away from the outer peripheral surface of the fluid holding cylinder 12b by its elastic force, and as a result, the microneedle insertion amount restricting portion 14c at the extending end of the elastic piece portion 14b is shown in FIG. It is allowed to move from the operating position as shown to the initial position as shown in FIG.

  According to the concept of the present invention, the microneedle insertion amount restricting device 14 is formed separately from the fluid holding cylinder 12b of the fluid injector 12, and then the proximal end portion is formed on the outer peripheral surface of the fluid holding cylinder 12b of the fluid injector 12. 14 a may be fixed, or the microneedle insertion amount regulating device 14 may be formed integrally with the fluid holding cylinder 12 b of the fluid injector 12.

  In this embodiment, a pair of elastic pieces 14b are provided at the base end portion 14a at equal intervals in the circumferential direction of the outer peripheral surface of the fluid holding cylinder 12b, for example, approximately 180 ° apart from each other. 14b may be only one or a plurality of pairs.

  When the microneedle insertion amount restricting portion 14c at the extending end of the elastic piece portion 14b is disposed at the operating position shown in FIGS. 1C and 1D, the multi-microneedle device 10 is provided. It is preferable that the skin contact surface 10d of the main body 10b has a shape that covers as much of the region surrounding the plurality of microneedles 10c as possible.

  For this reason, when there is only one elastic piece portion 14b, the microneedle insertion amount restricting portion 14c at the extending end of the elastic piece portion 14b is connected to the initial position and the microneedle insertion amount restricting portion 14c. It is a substantially U-shaped planar shape in which notches are formed so as not to collide with the plurality of microneedles 10c on the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 while moving between the operating positions. I can do it. When there are a plurality of elastic piece portions 14b and microneedle insertion amount regulating portions 14c, a plurality of microneedle insertion amount regulating portions 14c are plural on the skin contact surface 10d of the main body 10b of the multi-microneedle device 10. The ring shape covering the region surrounding the microneedle 10c can be a planar shape divided by the plurality of numbers.

[Another embodiment]
Next, a microneedle insertion amount regulating device 14 'according to another embodiment of the present invention will be described with reference to FIGS.

  This microneedle insertion amount regulating device 14 ′ includes a fluid injector holder 18 that detachably holds a fluid injector 12 using the multi-microneedle device 10.

  The configuration of the fluid injector 12 using the multi-microneedle device 10 used in this embodiment is the fluid injector 12 using the multi-microneedle device 10 described above with reference to FIGS. The configuration is the same. Accordingly, the description of the configuration of the multi-microneedle device 10 and the fluid injector 12 shown in FIGS. 2A to 2D has been described above with reference to FIGS. 1A to 1D. The same reference numerals as those used for the components of the fluid injector 12 using the multi-microneedle device 10 are used for the multi-microneedle device 10 shown in FIGS. The corresponding components of the fluid injector 12 are also omitted by attaching them.

  The fluid injector holder 18 provided in the microneedle penetration amount regulating device 14 'according to another embodiment of the present invention is a fluid for injecting into the skin tissue of a living organism, for example, a human, such as a drug solution. The fluid injector 12 in which the desired amount is already filled in the fluid holding space of the fluid holding cylinder 12b and the main body 10a of the multi-microneedle device 10 and the minute fluid injection paths of the plurality of microneedles 10c of the multi-microneedle device 10 It is configured to be detachably held.

  More specifically, the fluid injector holder 18 is frictionally engaged with the fluid holding cylinder 12b of the fluid injector 12 and the longitudinal half of the outer peripheral surface of the fluid outlet 12a, and the piston member 12c of the fluid injector 12 has its longitudinal length. The fluid injector holding groove 18a is movably accommodated in the direction. The fluid injector holding groove 18a includes an opening on the outer peripheral surface of the fluid injector holding body 18 that allows the fluid injector 12 to be attached to and detached from the fluid injector holding groove 18a.

  As described above, the fluid injector 12 can be a combination of a syringe barrel and a piston member of a known syringe, and for this reason, the fluid injector holding groove 18a of the fluid injector holder 18 is provided with a known syringe. It includes a positioning portion 18c for removably receiving the needle member 12d of the syringe barrel and positioning the fluid injector 12 in the fluid injector holding groove 18a.

  The multi-microneedle device 10 attached to the fluid injector 12 positioned by the positioning portion 18c in the fluid injector holding groove 18a of the fluid injector holder 18 is provided with the fluid injector holder of the fluid injector holder 18. The groove 18a is exposed to the external space. That is, the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 and the plurality of microneedles 10c are projected into the external space.

  The fluid injector holder 18 includes a piston member operating rod 18b that can move in the direction of movement of the piston member 12c relative to the fluid holding cylinder 12b on the protruding end side of the piston member 12c in the fluid injector holding groove 18a. In the piston member operation rod 18b, the end of the fluid injector 12 opposite to the piston member 12c in the fluid injector holding groove 18a protrudes into the external space.

  The microneedle penetration amount regulating device 14 'according to this embodiment is different from the microneedle penetration amount regulating device 14 according to the embodiment described above with reference to FIGS. 1 (A) to (D). The base end portion 14 ′ a is separated from the multi-microneedle device 10 along the longitudinal direction of the fluid holding cylinder 12 b of the fluid injector 12 in the fluid injector holding groove 18 a with respect to the fluid injector holder 18. It is fixed. That is, the base end portion 14 ′ a of the microneedle insertion amount regulating device 14 ′ can be attached to and detached from the fluid injector 12 in the fluid injector holding groove 18 a of the fluid injector holder 18 through the fluid injector holder 18. Thus, the fluid holding cylinder 12b is fixed away from the multi-microneedle device 10 along the longitudinal direction of the fluid holding cylinder 12b.

  The other configuration of the microneedle insertion amount regulating device 14 ′ according to another embodiment of the present invention is the same as that of the microneedle insertion amount regulating device 14 described above with reference to FIGS. Same as the configuration. Accordingly, the description of the configuration of the microneedle insertion amount regulating device 14 'shown in FIGS. 2A to 2D will be described with reference to FIGS. 1A to 1D. In the microneedle insertion amount regulating device 14 ′ shown in FIGS. 2A to 2D, the same reference numerals as those assigned to the constituent members of the needle insertion amount regulating device 14 correspond. It is omitted by attaching to the constituent members.

  Next, referring to FIGS. 2A to 2D, the multi-microneedle device 10 is used in combination with the microneedle insertion amount regulating device 14 'according to another embodiment of the present invention. The fluid injector 12 is operated to inject the fluid held by the fluid injector 12 into the skin tissue at the desired location of the living body, for example, a person in this embodiment, for example, the human skin. Explain the procedure.

  A desired amount of a fluid, for example, a chemical solution, to be injected into the skin tissue of a living organism, for example, a person, is a fluid holding space in the fluid holding cylinder 12b and the main body 10a of the multi-microneedle device 10 and a plurality of micro The minute fluid injection path of the needle 10c is already filled.

  The fluid injector 12 is shown in FIG. 2A in a predetermined position in the fluid injector holding groove 18a of the fluid injector holder 18 of the microneedle insertion amount regulating device 14 ′. As shown in FIG.

  Then, the user of the fluid injector 12 combined with the microneedle insertion amount regulating device 14 'according to another embodiment of the present invention described above and using the multi-microneedle device 10 can insert the microneedle. As shown in FIG. 1 (A), the microneedle insertion amount restricting portion 14c of the amount restricting device 14 ′ is disposed on the side of the main body 10b from the skin contact surface 10d of the main body 10b of the multi-microneedle device 10. While being arranged by the elastic force of the elastic piece portion 14b at the initial position moved toward the base end portion 14'a, the outer peripheral surface of the fluid injector holder 18 is gripped, and then the skin of a living organism such as a human being The skin contact surface 10d of the main body 10b of the multi-microneedle device 10 is pressed against a desired position where the SK is exposed.

  At this time, the plurality of microneedles 10c on the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 is reliably pierced into the skin tissue in the region (see FIG. 2A).

  Also, at this time, the elasticity of the skin tissue in the above-mentioned desired position where the skin SK to which the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 is pressed is exposed is somewhat lost.

  Next, the elastic piece 14b of the microneedle insertion amount restricting device 14 'is pushed toward the outer peripheral surface of the fluid injector holder 18 against the elastic force, that is, toward the outer peripheral surface of the fluid holding cylinder 12b. 2 (C) and (D), the microneedle insertion amount restricting portion 14c at the extending end of the elastic piece portion 14b is moved to the initial position shown in FIG. To the operating position corresponding to the region surrounding the plurality of microneedles 10 c on the skin contact surface 10 d of the main body 10 b of the multi-microneedle device 10.

  The microneedle insertion amount regulating portion 14c at the extended end of the elastic piece portion 14b moved to the operating position is higher than the protruding height of the plurality of microneedles 10c from the skin contact surface 10d of the main body 10b of the multi-microneedle device 10. Since it has a small thickness, the microneedle insertion amount restricting portion 14c at the extending end of the elastic piece portion 14b moved to the operating position is provided with a plurality of micros from a desired position where the skin SK is exposed. The needle 10c is not pulled out.

  In addition, at the desired position where the skin SK is exposed, the elastic piece portion 14b moved to the operating position is moved to the region not pushed by the microneedle insertion amount restricting portion 14c, that is, to the operating position. In the region where the plurality of microneedles 10c protrude from the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 surrounded by the microneedle insertion amount regulating portion 14c at the extending end of the elastic piece portion 14b. The corresponding region expands toward the skin contact surface 10d as the elasticity is restored.

  During this time, the user presses the piston member operating rod 18b of the fluid injector holder 18 as shown by an arrow P in FIG. As a result, the piston member 12c of the fluid injector 12 is pressed through the piston member operating rod 18b, and the fluid holding cylinder 12b of the fluid injector 12, the fluid holding space of the main body 10a of the multi-microneedle device 10, and a large number of The fluid filled in the microfluidic injection path of the microneedle 10c as described above is passed through the microfluidic injection paths of the multiple microneedles 10c of the multi-microneedle device 10 according to the pressing distance, and the skin. In the skin tissue of the region where the elasticity is restored as described above at the desired position where the SK is exposed, and outside the skin SK as indicated by a plurality of arrows I in FIG. Can be quickly and easily injected without leaking.

  After the injection of the fluid from the fluid injector 12 into the skin tissue in the region at the desired position where the skin SK is exposed through the multiple microneedles 10c of the multi-microneedle device 10 is completed. The fluid injector holder 18 holding the fluid injector 12 is pulled away from the desired position where the skin SK is exposed, and at the same time, the plurality of microneedles 10c of the multi-microneedle device 10 are exposed to the skin SK. It is extracted from the skin tissue of the region at the desired location described above.

  Next, if the pressing force applied to the elastic piece portion 14b of the microneedle insertion amount regulating device 14 'is released, the microneedle insertion amount regulating portion 14c at the extending end of the elastic piece portion 14b becomes as shown in FIG. Returning from the operating position shown in (C) to the initial position shown in (A) of FIG. 2 by the elastic force of the elastic piece 14b.

  In this embodiment as well, the microneedle insertion amount regulating device 14 ′ is configured so that the outer peripheral surface of the fluid injector holder 18 and the outer peripheral surface of the fluid holding cylinder 12 b of the fluid injector 12 are connected to the microneedle insertion amount regulating device 14. An annular elastic piece operating member 16 that surrounds the base end portion 14'a or the elastic piece portion 14b and is movable along the longitudinal direction of the fluid injector holder 18, that is, the longitudinal direction of the fluid holding cylinder 12b. It has more.

  Also in the microneedle insertion amount restricting device 14 ', the annular elastic piece portion operating member 16 has an initial position disposed on the base end portion 14'a as shown in FIG. (C) of the fluid injector holder 18 on the base end portion 14'a and the elastic piece portion 14b between the operating position contacting the elastic piece portion operating member retaining member 14d as shown in FIG. It is movable along the longitudinal direction, and hence the longitudinal direction of the fluid holding cylinder 12b.

  While the annular elastic piece portion operating member 16 is disposed at the initial position on the base end portion 14'a as shown in FIG. 2A, the elastic piece portion 14b is moved by its elastic force. The microneedle insertion amount restricting portion 14c at the extended end of the elastic piece portion 14b is disposed at the initial position away from the outer peripheral surface of the fluid injector holder 18 and by extension, the outer peripheral surface of the fluid holding cylinder 12b.

  The elastic piece operating member 16 is moved from the initial position on the base end 14'a shown in FIG. 2A toward the extending end of the elastic piece 14b. The portion 14b is pushed against the elastic force toward the outer peripheral surface of the fluid injector holder 18 and thus the outer peripheral surface of the fluid holding cylinder 12b, and the microneedle insertion amount regulating portion 14c at the extended end of the elastic piece portion 14b is pressed. It is possible to move from the initial position to the operating position as shown in FIG.

  An annular elastic piece operating member 16 that is moved on the elastic piece portion 14b toward the extending end of the elastic piece portion 14b along the outer peripheral surface of the fluid injector holder 18 and thus the outer peripheral surface of the fluid holding cylinder 12b, The elastic piece portion 14b is prevented from falling off from the extended end by coming into contact with the elastic piece portion operating member retaining member 14d on the elastic piece portion 14b.

  When the annular elastic piece portion operating member 16 is moved from the elastic piece portion 14b toward the initial position as shown in FIG. 2A on the base end portion 14'a, and reaches the initial position. The elastic piece portion 14b is allowed to move away from the outer peripheral surface of the fluid injector holder 18 and by extension the outer peripheral surface of the fluid holding cylinder 12b by its elastic force. As a result, the microneedle stab at the extended end of the elastic piece portion 14b is allowed. The entrainment amount restricting portion 14c is allowed to move from the operating position as shown in FIG. 2C to the initial position as shown in FIG.

  According to the concept of the present invention, the microneedle insertion amount regulating device 14 ′ is formed separately from the fluid injector holder 18, and then the base end portion 14 ′ a is fixed on the outer peripheral surface of the fluid injector holder 18. Alternatively, the microneedle insertion amount restricting device 14 ′ may be formed integrally with the fluid injector holder 18.

  Also in this embodiment, the elastic pieces 14b are arranged at regular intervals in the circumferential direction of the outer peripheral surface of the fluid injector holder 18 at the base end portion 14'a, and thus in the circumferential direction of the outer peripheral surface of the fluid holding cylinder 12b, for example, mutually One pair is provided at a distance of approximately 180 °, but there may be only one elastic piece portion 14b or a plurality of one or more pairs.

  When the microneedle insertion amount regulating portion 14c at the extending end of the elastic piece portion 14b is disposed at the operating position shown in FIGS. 2C and 2D, the multi-microneedle device 10 It is preferable that the skin contact surface 10d of the main body 10b has a shape that covers as much of the region surrounding the plurality of microneedles 10c as possible.

  For this reason, when there is only one elastic piece portion 14b, the microneedle insertion amount restricting portion 14c at the extending end of the elastic piece portion 14b is connected to the initial position and the microneedle insertion amount restricting portion 14c. It is a substantially U-shaped planar shape in which notches are formed so as not to collide with the plurality of microneedles 10c on the skin contact surface 10d of the main body 10b of the multi-microneedle device 10 while moving between the operating positions. I can do it. When there are a plurality of elastic piece portions 14b and microneedle insertion amount regulating portions 14c, a plurality of microneedle insertion amount regulating portions 14c are plural on the skin contact surface 10d of the main body 10b of the multi-microneedle device 10. The ring shape covering the region surrounding the microneedle 10c can be a planar shape divided by the plurality of numbers.

  DESCRIPTION OF SYMBOLS 10 ... Multi microneedle device, 10a ... Fluid outlet, 10b ... Main body, 10c ... Microneedle, 10d ... Skin contact surface, 12 ... Fluid injector, 12a ... Fluid outlet, 12b ... Fluid holding cylinder, 12c ... Piston member 14, 14 '... Microneedle insertion amount regulating device, 14a, 14'a ... Base end portion, 14b ... Elastic piece portion, 14c ... Microneedle insertion amount regulating portion, 14d ... Elastic piece portion operating member retaining member, 16 ... elastic piece part operation member, SK ... skin tissue, 18 ... fluid injector holder, 18a ... fluid injector holding groove, 18b ... piston member operation rod.

Claims (3)

A microneedle penetration control device for a fluid injector that uses a multi-microneedle device:
A proximal end fixed away from the multi-microneedle device along the longitudinal direction of the fluid retaining cylinder with respect to the fluid retaining cylinder of the fluid injector;
Elasticity extending from the base end to the skin contact surface of the main body of the multi-microneedle device along the outer peripheral surface of the fluid holding cylinder, and moving away from the outer peripheral surface of the fluid holding cylinder as the extension distance from the base end increases One part; and
The skin contact of the main body of the multi-microneedle device is provided at the extending end of the elastic piece and has a predetermined thickness smaller than the protruding height of the plurality of microneedles from the skin contact surface of the main body of the multi-microneedle device. A microneedle insertion amount regulating portion arranged by an elastic force of an elastic piece at an initial position moved from the surface toward the side of the main body and toward the base end;
With
A plurality of microneedles on the skin contact surface of the main body of the multi-microneedle device from the initial position by the elastic piece being pushed toward the outer peripheral surface of the fluid holding cylinder against the elastic force, Move to the operating position corresponding to the area surrounding
A microneedle insertion amount regulating device characterized by that.   Surrounding the outer peripheral surface of the fluid holding cylinder of the fluid injector together with the base end part or the elastic piece part, and movable along the longitudinal direction of the fluid holding cylinder, the base end part in the base end part or the elastic piece part The microneedle insertion amount restricting portion is moved toward the extending end of the elastic piece portion from the side to push the elastic piece portion toward the outer peripheral surface of the fluid holding cylinder against the elastic force to move the microneedle insertion amount restricting portion to the initial position. To the operating position and moved from the extended end of the elastic piece part toward the base end part or the base end part side of the elastic piece part, whereby the elastic piece part is fluidized by its elastic force. The microneedle insertion amount regulating device according to claim 1, further comprising an annular elastic piece portion operating member that allows moving away from the outer peripheral surface of the holding cylinder. A fluid injector holding body for holding the fluid injector detachably by projecting the skin contact surface of the main body of the multi-microneedle device and the plurality of microneedles to the external space;
The microneedle penetration amount regulating device according to claim 1 or 2, wherein the base end portion is fixed to the outer peripheral surface of the fluid injector holder.

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