WO2017182887A2 - Injection device - Google Patents

Injection device Download PDF

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Publication number
WO2017182887A2
WO2017182887A2 PCT/IB2017/000651 IB2017000651W WO2017182887A2 WO 2017182887 A2 WO2017182887 A2 WO 2017182887A2 IB 2017000651 W IB2017000651 W IB 2017000651W WO 2017182887 A2 WO2017182887 A2 WO 2017182887A2
Authority
WO
WIPO (PCT)
Prior art keywords
movable holder
needle
injection
injection device
contact head
Prior art date
Application number
PCT/IB2017/000651
Other languages
French (fr)
Japanese (ja)
Other versions
WO2017182887A8 (en
WO2017182887A3 (en
Inventor
陽介 中沢
征嗣 佐藤
佐藤 敬
道宏 仮谷
田中 聡
Original Assignee
株式会社資生堂
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
Application filed by 株式会社資生堂 filed Critical 株式会社資生堂
Priority to KR1020187032981A priority Critical patent/KR102388573B1/en
Priority to SG11201808894RA priority patent/SG11201808894RA/en
Priority to CN201780018464.7A priority patent/CN109328082B/en
Publication of WO2017182887A2 publication Critical patent/WO2017182887A2/en
Publication of WO2017182887A8 publication Critical patent/WO2017182887A8/en
Publication of WO2017182887A3 publication Critical patent/WO2017182887A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles

Definitions

  • the present invention relates to an injection device, and more specifically to a device suitable for injecting, supplying, or administering various substances including cells into a tissue.
  • a predetermined substance such as a cell into a treatment site in the skin precisely and in a desired amount at a predetermined depth.
  • a predetermined amount may be divided into multiple times and distributed in a plurality of different directions. Necessary.
  • the predetermined amount of content is divided into a plurality of times and injected in a distributed manner from a plurality of different directions, it is desirable that the influence on the subject is equally divided. It may be desired to be injected at the same predetermined rate each time.
  • an injection needle housing for fixing the injection needle is provided in the injection device, the injection needle is fixed inside, and the syringe barrel is detachably attached to the fixed injection needle.
  • Patent Document 1 is proposed. In this injection apparatus, an injection operation is performed at a predetermined speed by an internal drive system and a retraction system.
  • the device may be handled as a more advanced medical device, and the notification and conveyance of the device become strict. There was a fear.
  • the present invention aims to provide an injection device that prevents the injection needle from falling off from the syringe barrel during use and can be attached to and detached from the syringe.
  • a syringe including a pusher, a syringe barrel into which the pusher is inserted, and a needle base connected to the syringe barrel and a needle tube punctured into a subject.
  • An injection device for injecting contents into the subject is capable of contacting the subject and has a contact head formed with an opening through which the needle tube passes; a movable holding the syringe barrel and the injection needle A holder; a support mechanism fixed to the abutment head; and a content injection control mechanism for pushing the pusher into the syringe barrel, and the movable holder moves along the support mechanism.
  • the injection device can prevent the syringe needle from falling off from the syringe barrel and remove the syringe during use.
  • FIG. 11 is an enlarged view of a needle extraction control mechanism of the injection device of FIG. 10.
  • FIG. 11 is a perspective view of the injection device of FIG. 10. Operation
  • FIG. 1 is an explanatory diagram of the injection device according to the first embodiment of the present application.
  • (A) is a sketch and (b) is a side view.
  • the injection device 1 is an injection device to which a syringe that injects a content containing a substance such as a cell suspension into a subject (human, animal, individual organ, skin, etc.) is attached.
  • the injection device 1 functions as an injection syringe holder (injector holder) for injecting an appropriate amount of contents into a subject using a syringe.
  • the injection device includes a contact head 10, a support mechanism 20, a movable holder 30, and a content injection control mechanism 50.
  • the contact head 10 can contact the subject and has an opening.
  • the contact head 10 is located at the tip of the injection device 1.
  • a later-described needle tube 83 performs a puncture operation / needle extraction operation on a subject, the tube passes through the opening 11 (see FIG. 4B).
  • the support mechanism 20 is fixed to the contact head 10 at a predetermined angle.
  • the injection angle with respect to the subject is set by the coupling angle between the support mechanism 20 and the contact head 10.
  • the abutting head 10 and the support mechanism 20 may be integrally manufactured, or may be fixed separately by welding or the like after manufacturing.
  • the support mechanism 20 is a holder receiving part that defines the stop position of the movement of the movable holder 30 and receives the movable holder 30.
  • the movable holder 30 holds the syringe barrel 84 and the injection needle 81 (see FIG. 2A) and is movable along the support mechanism 20 with respect to the contact head 10.
  • the syringe cylinder 84 and the injection needle 81 held by the movable holder 30 are moved with respect to the subject in contact with the contact head 10.
  • the needle tube 83 of the syringe 80 moves relative to the subject in a forward direction that is a puncturing direction and a backward direction that is a direction in which the needle is removed.
  • the content injection control mechanism 50 pushes the pusher 88 into the syringe barrel 84.
  • the content injection control mechanism includes a pressing portion 40, a guide rod 51, an interlocking rod 52, a connecting rod 53, and elastic members 54 and 55 (see FIG. 5).
  • FIG. 2 is an explanatory view of the syringe, wherein (a) shows the assembled syringe, and (b) shows an exploded view of the syringe.
  • the syringe 80 includes an injection needle 81, an injection cylinder 84, and a pusher 88.
  • a syringe cylinder (cylinder) 84 accommodates the contents, and a pusher 88 is inserted.
  • the syringe cylinder 84 includes an outer cylinder portion 85 that stores the contents, a flange 86 provided at the rear end of the outer cylinder portion 85, and a cylinder tip 87.
  • a syringe having a volume of 1 mL is used in the injection device of the present invention.
  • a 1 mL syringe allows for 10 100 ⁇ L injections and 6 166 ⁇ L injections.
  • Syringes with 2, 5, or 10 mL can also be used.
  • the syringe may have a larger or smaller volume.
  • the injection needle 81 is connected to the syringe barrel 84.
  • the injection needle 81 includes a needle base 82 that is externally fitted to the tube tip 87 of the injection tube 84 and a needle tube 83 that is punctured into the subject.
  • the tube tip 87 of the syringe tube 84 is inserted into the needle base 82 of the injection needle 81 and engaged. You may use the syringe which has a structure which locks so that the needle base 82 of the injection needle 81 and the cylinder tip 87 of the injection cylinder 84 may not remove easily.
  • the diameter of the needle tube of the injection needle applied to the injection device of the present invention is preferably in the range of 18 to 34G, 20 to 30G. More preferably, it is 26G, 27G, or 30G.
  • the pusher 88 (plunger) is moved in the outer cylinder part 85 of the injection cylinder 84 by pressing the head (rear part) 88h, whereby the contents are released from the syringe.
  • a gasket 89 which is a thin rubber packing (sealing element) for preventing liquid leakage and foreign matter mixing is bonded to the tip of the pusher 88.
  • the syringe cylinder 84 and the injection needle 81 as shown in FIG. 2A can be integrated and detached together, the contents contained in the syringe cylinder 84 are
  • the injection device 1 can be reused without adhering to the inside or with as little adhesion as possible.
  • the injection tube 84 and the injection needle 81 need only be integrated by connection at least when being attached to and detached from the injection device 1 and mounted in the injection device 1.
  • the syringe tube 84 and the injection needle 81 may be in separate states.
  • FIG. 3 shows an enlarged cross-sectional view of the upper surface of the movable holder 30.
  • A is a perspective view
  • (b) is a cross-sectional top view cut along AA ′ in (a).
  • the movable holder 30 is formed with a syringe holder made up of a front holder 310 and a rear holder 320, and two through holes (331, 332, see FIG. 5) through which the rod-shaped members 51, 52, 53 pass.
  • the moving support part 330 is provided.
  • coil springs 54 and 55 which are first elastic members are provided inside the movement support portion 330.
  • the upper part 310 and 320 of the movable holder includes a flange fitting part 31, an outer cylinder part holding part 32, a needle base stopper 33, and a peripheral surface holding part 34.
  • the flange fitting part 31 is fitted with the flange 86 of the syringe barrel 84.
  • the flange fitting portion 31 has a wing-shaped outer frame shape in a top view, and is engaged by fitting the flange 86 into the outer frame shape. By this engagement, the flange 86 is positioned, and the flange 86 is restricted from moving in the separating direction (retracting direction, arrow B direction in FIG. 1B) with respect to the movable holder 30.
  • the outer cylinder part clamping part 32 holds the position of the outer cylinder part 85 of the injection cylinder 84 from both sides.
  • the outer cylinder part clamping part 32 is a linear protrusion shape that stands up in a rib shape so as to extend along both sides of the side surface of the cylindrical outer cylinder part 85.
  • the outer cylinder part clamping part 32 regulates the lateral displacement of the outer cylinder part 85, that is, the lateral displacement in the movable holder 30. Even if the movable holder 30 moves, the holding state can be stably maintained.
  • the needle base stopper 33 restricts the movement of the needle base 82 of the injection needle 81.
  • the tip of the needle base 82 has a predetermined surface shape, and the needle base stopper 33 shown in FIG. 3 is reduced in inner diameter (provided with a step). The tip end surface of the needle base 82 can be contacted.
  • the needle base stopper 33 extends perpendicularly to the direction of stopping the moving direction of the syringe 80 and passes through the needle tube 83, but the tip of the needle base 82 (the surface perpendicular to the moving direction). ) Is in contact with the needle base stopper 33 to restrict the movement of the syringe 80 relative to the movable holder 30.
  • the needle base stopper 33 does not have to be perpendicular to the direction in which the syringe 80 is moved.
  • the needle base 82 may be stopped by gradually reducing the shape of the circumference.
  • the needle base stopper 33 when there is no vertical surface at the tip of the needle base 82 and the shape of the needle base 82 gradually increases in diameter toward the portion where the needle base 82 is connected, the needle base stopper 33 However, the movement of the syringe 80 relative to the movable holder 30 may be regulated by contacting the side surface of the needle base 82.
  • the peripheral surface holding portion (needle base peripheral surface holding portion) 34 holds the peripheral surface of the needle base 82 of the injection needle 81 in a peripheral shape.
  • the peripheral surface holding part 34 may hold
  • the circumferential surface holding portion 34 shown in FIG. 3 has a cylindrical shape that covers the entire circumferential surface along the circumferential surface direction of the tips of the needle base 82 and the outer cylindrical portion 85.
  • the peripheral surface holding part 34 does not have to cover the entire periphery, and may be, for example, a shape that follows the shape of the tip of the needle base 82 and the outer cylinder part 85 along a semicircular shape.
  • the circumferential surface holding portion 34 regulates lateral displacement of the needle base 82 and the outer cylinder portion with respect to the movable holder 30.
  • the flange fitting portion 31 restricts the movement of the syringe cylinder 84 in the separating direction (the backward direction of the arrow B in FIG. 1B), and the needle base stopper 33 is used for the injection.
  • the needle base stopper 33 is used for the injection.
  • the outer cylinder part clamping part 32 of the movable holder 30 does not need to stand in all the parts along the outer cylinder part 85 of the syringe 80.
  • FIG. 3A by providing the flat surface portion 35 in which a part of the protrusion of the outer tube portion clamping portion 32 is interrupted, it is easy to fit the syringe 80 into the movable holder 30. The operability when attaching / detaching 80 is improved.
  • FIG.4 and FIG.1 The support mechanism 20 is demonstrated using FIG.4 and FIG.1 (b).
  • 4A shows a perspective view of the contact head 10 and the support mechanism 20
  • FIG. 4B shows a perspective view seen from another direction.
  • (C) shows the arrow view seen from the injection
  • FIG. The contact head 10 and the support mechanism 20 function as a fixed member (main body) that is immovable with respect to the movable holder 30 that is movable.
  • the support mechanism 20 is fixed to the contact head 10.
  • the contact angle of the needle tube 83 of the syringe 80 with respect to the subject is set by the connection angle between the contact head 10 and the support mechanism 20.
  • the angle between the support mechanism 20 and the contact head 10 that defines the injection angle may be preferably 10 degrees to 90 degrees, but if it is within a range of 15 degrees to 25 degrees, Furthermore, it is more preferable.
  • the support mechanism 20 includes an upper surface cover 24 and a side wall 23, and a cylindrical holder guide path (insertion through hole) 21 that guides the movement of the movable holder 30 is formed inside the support mechanism 20.
  • a cylindrical holder guide path (insertion through hole) 21 that guides the movement of the movable holder 30 is formed inside the support mechanism 20.
  • an opening 23 ⁇ / b> O which is an entrance of an insertion hole of the holder guide path 21 into which the movable holder 30 is inserted is formed in the side wall 23 positioned at the rear end of the support mechanism 20.
  • the lower part of the holder guide path 21 that allows the movable holder 30 to move along the support mechanism 20 functions as a movement guide rail 22 that guides the movement of the movable holder 30.
  • the support mechanism 20 is provided with a cut (opening) 25 extending in the lateral direction (injection direction)). Opening the lower portion prevents the tip of the needle tube 83 from coming into contact with the inside of the injection device 1 when the syringe 80 is attached or detached.
  • the movement guide rail 22 is a cylindrical insertion through-hole for inserting the tip of the movable holder 30 (at least the portion holding the injection needle 81), other than the lower surface of the inner peripheral surface of the holder guide path 21.
  • This part has a shape along the shape of the tip of the movable holder 30 (peripheral surface holding part 34).
  • the support mechanism 20 is an upper surface cover that covers at least a portion (the needle base stopper 33 and the peripheral surface holding portion 34) that holds the injection needle 81 and the injection needle 81 of the movable holder 30 in the upper surface and the lateral direction. 24. Therefore, in the present embodiment, the support mechanism 20 has a housing shape in which a lower portion is opened and a holder guide path 21 which is a cylindrical insertion hole extending in the moving direction to guide the movable holder 30 is provided. Yes.
  • the side wall 23 of the support mechanism 20 stops the movement (forward movement) of the movable holder 30 in the proximity direction to the contact head 10. That is, the end point of the slide movement is defined. Further, the front end of the guide bar 51 and the front end of the connecting bar 53 are fixed (connected) to the side wall 23 of the support mechanism 20. Specifically, the side wall 23 is provided with a side wall fixing portion 23G for fixing the guide rod 51 and a side wall fixing portion 23J for fixing the connecting rod 53 (see FIG. 5). As shown in FIG. 5, the side wall fixing portions 23G and 23J may include a fastening member for fastening the guide rod 51 and the connecting rod 53, an adhesive member for bonding, and the like.
  • the cylindrical housing forming the holder guide path may be open at the top (the upper surface cover 24 may not be provided).
  • the support mechanism 20 defines, at a minimum, a movement guide rail 22 that moves and guides a part of the movable holder 30 (a part that holds the needle part) to the contact head 10 and an end point of the movement. It is sufficient if there is a side wall 23 that serves as a stopper.
  • [Content injection control mechanism] 5A is an exploded view showing the content injection control mechanism 50 of the present invention, and FIG. 5B shows the content injection control mechanism 50 and the moving support portion 330 on the lower surface of the movable holder 30.
  • FIG. It is sectional drawing. Note that FIG. 5B corresponds to a cross-sectional view of the BB ′ plane in FIG.
  • the injection device 1 includes, as the content injection control mechanism 50, a pressing portion 40, a guide bar 51, an interlocking bar 52, a connecting bar 53, a coil spring (first elastic member) 54, 55.
  • the pressing unit 40 presses the pusher 88 against the inside of the syringe barrel 84 held by the movable holder 30.
  • the guide rod 51, the interlocking rod 52, and the connecting rod 53 are rod-shaped members that control the relative movement of the movable holder 30.
  • the guide rod 51 is engaged with the movable holder 30 and the pressing portion 40 so as to be relatively movable.
  • the interlocking rod 52 is fastened to the movable holder 30 and is movably engaged with the pressing portion 40.
  • the connecting rod 53 extends in the same straight line as the interlocking rod 52, and the end portion (rear end) faces the end portion (front end) of the interlocking rod 52 and can be contacted / separated. Further, the tip of the connecting rod 53 is located inside the movable holder 30.
  • the first elastic members (coil springs) 54 and 55 are provided inside the movable holder 30.
  • the lower part of the movable holder 30 shown in FIG. 5B shows a moving support part 330 provided at the lower part of the part for holding the syringe barrel 84.
  • a first through hole 331 through which the guide rod 51 is slidably inserted, and a connecting rod 53 is slidably inserted at the tip, and the interlocking rod 52 is fastened to the rear end on the same straight line.
  • the second through hole 332 is formed.
  • the guide rod 51 and the connecting rod 53 are movable with respect to the through holes 331 and 332 of the movable holder 30 respectively.
  • the interlocking rod 52 is fixed to the through hole 332 of the movable holder 30 at a predetermined position by the adhesive member 38.
  • the pressing part 40 is engaged with the guide bar 51 and the interlocking bar 52.
  • the pressing portion 40 is a pusher pushing portion that abuts against the head (rear end portion) 88h of the pusher 88 and pushes the pusher 88 by relative movement.
  • the distance between the movable holder 30 and the contact head 10 and the distance between the movable holder 30 and the pressing portion 40 are changed by the restoring force of the coil springs 54 and 55 provided on the movable holder 30. Details of the change in the distance will be described later with reference to FIGS.
  • the compressive force applied to the coil springs 54 and 55 is constant. Therefore, when a predetermined amount of content is divided into a plurality of times and the injection amount is equal each time, the moving amount of the movable holder 30 becomes constant, so that the compression force and the subsequent restoring force of the coil springs 54 and 55 are obtained. Is constant, so that the injection operation can be performed at the same injection speed each time.
  • the protrusions 36 and 37 are provided on the inner walls of the through holes 331 and 332 through which the rod-shaped members 51, 52, and 53 are provided.
  • the protrusions 36 and 37 that is, the portions having small diameters in the through holes 331 and 332 are provided.
  • the guide rod 51 and the connecting rod 53 are each provided with a small diameter portion and a large diameter portion.
  • the small diameter portions 51S and 53S are located near the center of the movable holder 30 in the extending direction of the guide rod 51 and the connecting rod 53, and the large diameter portions 51F and 53F are on the support mechanism 20 side (tip side) of the movable holder 30. Located in.
  • the coil springs 54 and 55 are fitted on the small diameter portions 51S and 53S of the guide rods 51 and 53, respectively.
  • the guide bar 51 on which the coil spring 54 is fitted is fitted in the through hole 331.
  • the connecting rod 53 to which the coil spring 55 is fitted and the fixed interlocking rod 52 are fitted in the through hole 332.
  • the leading end of the coil spring (first elastic member) is held by the side surface (stepped portion) of the guide rod 51 and the connecting rod 53 that is reduced in diameter from the large diameter portions 51F and 53F to the small diameter portions 51S and 53S, and the rear end is the spring.
  • the protrusions 36 and 37 which are holding members, are held on the protrusion side surfaces 36S and 37S.
  • the guide bar 51 and the connecting bar 53 are configured to be split so that the coil springs 54 and 55 can be fitted onto the small diameter portions 51S and 53S.
  • the end of the connecting rod 53 has a large diameter, and the large-diameter end 53T at the end can be separated from other parts.
  • a screw groove and a screw groove can be formed. Fastened by fitting.
  • the position where the step between the large-diameter end 53T and the small-diameter portion 53S at the end of the connecting rod 53 comes into contact with the surface of the protrusion 37 on the pressing portion 40 side and is caught is the distance between the movable holder 30 and the support mechanism 20. , The farthest position.
  • the pressing portion 40 side is designed to be close to the diameter of the through hole 331 and larger than the small diameter portion 51S (provided with a medium diameter portion 51M).
  • the medium diameter portion 51M remains in the through hole. This is because the support mechanism 20 can be moved relative to the guide bar 51 more smoothly because it moves along 332.
  • the movable holder 30 is a distance away from the support mechanism 20 D2 (distance D m to be described later) is before the start of the puncture, the distance D1 between the interlocking rod 52 and connecting rod 53, the corresponding. This distance sets the injection depth of the injection needle.
  • the injection depth of the needle tube 83 of the injection needle 81 is preferably in the range of 0.5 to 5.5 mm, and more preferably in the range of 2.0 mm to 3.5 mm.
  • FIG. 6 is an explanatory diagram of the ratchet mechanism in the pressing portion 40. Specifically, an exploded view of the pressing portion 40 is shown.
  • engaging racks 51r and 52r having inclinations are formed on the peripheral surface of the part that can face the pressing portion 40.
  • the pressing portion 40 includes pawls (plate springs) 41 that mesh with the engagement racks of the guide bar 51 and the interlocking bar 52.
  • the pressing portion 40 is provided with a leaf spring support bar 42 to which the pawl 41 is fixed and a case portion 44 that covers the pawl 41.
  • the leaf spring support rod 42 is movably attached to a support plate 45 fixed to the pressing portion 40.
  • a button 42h is provided on the opposite side to which the pawl 41 is fixed, and a compression coil spring 43 is externally fitted between the button 42h and the support plate.
  • the engagement configuration between the pawl 41 in the pressing portion 40 and the engagement racks 51r and 52r of the guide rod 51 and the interlocking rod 52 is a ratchet mechanism.
  • the pressing portion 40 can move relative to the guide rod 51 and the interlocking rod 52 in a direction approaching the movable holder 30, and move in a direction away from the movable holder 30 in a relatively separating direction (retracting direction). The movement is locked.
  • FIG. 7 is an enlarged view of the contact head 10. As shown in FIG. 7, the contact head 10 has an upper surface 13, a side surface 14, and a lower surface 12. The shape of the upper surface 13 and the lower surface 12 of the contact head 10 is circular, horseshoe-shaped, or polygonal.
  • the opening 11 penetrates the upper surface 13 and the lower surface 12 of the contact head 10. Moreover, the needle
  • the lower surface 12 of the contact head 10 is positioned such that the surface 12 c around the opening 11 is located inside the other lower surface (for example, the lower surface protrusion 12 e). It is configured. If the lower surface 12 is configured in this way, when the contents are injected into the subject, the lower surface 12 partially contacts the subject, and the periphery of the opening 11 is not in contact with the subject.
  • the lower surface protrusion that continuously protrudes in the surface direction of the lower surface on the circumferential portion that is the edge of the lower surface of the circular contact head 10 12e is formed.
  • the top part of the circumferential lower surface protrusion 12e abuts on the subject so as to surround the periphery of the opening 11.
  • the lower surface protrusion 12e is not limited to a continuous shape, and may be an intermittent shape such as a leg shape.
  • the lower surface 12 of the contact head 10 By configuring the lower surface 12 of the contact head 10 in this way, a predetermined space is provided between the periphery of the opening 11 and the subject. Accordingly, when a liquid such as leaked liquid or blood flows out from the subject during the injection operation, the liquid comes into contact with the lower surface of the contact head 10 around the opening 11, so that the liquid spreads on the lower surface 12. To prevent adhesion.
  • the needle tube 83 is configured such that the tip of the needle tube 83 is positioned above the portion of the lower surface 12 of the contact head 10 that contacts the subject before the puncture operation and after the needle extraction operation.
  • the needle tube 83 of the syringe applied to the injection device of the present invention is such that the tip of the needle tube 83 is positioned above the portion of the lower surface of the contact head 10 that contacts the subject before the puncture.
  • the length of the needle tube 83 is selected and used.
  • the injection volume may be different at each separate injection site at a separate injection depth.
  • the injection length range defines the length of the injection path during the retracting operation of the injection needle. Therefore, it is foreseen that the total injection length is determined by the length of the injection needle.
  • the total injection length of the injection needle is preferably 2.0 mm to 50 mm, and more preferably 5.0 mm to 40 mm.
  • the tip of the needle tube 83 of the injection needle 81 does not contact the subject, so that the subject is stuck with the needle tube 83 when the injection device is separated from the subject. Therefore, it can be prevented from moving in an unexpected direction. Therefore, the safety of the injection device is improved.
  • a collar portion 16 protruding from the side surface 14 may be provided.
  • the opening 11 has an elongated hole shape that is elongated from the position corresponding to the injection point toward the support mechanism 20 on the upper surface.
  • the shape of the opening 11 seen from above is formed in the shape of a long hole as described above, so that when performing the injection operation, the injection direction is clarified and the operator's needle tube for the injection operation is visually recognized. Longer possible time. By clarifying the injection direction, the injection operation can be performed at a more accurate position with respect to the target injection point. Further, since the visible time of the needle tube becomes longer, it can be discovered before the injection operation is started when there is an abnormality such as bending or cutting in the needle tube 83. Therefore, it is possible to prevent an abnormal injection operation on the subject in advance.
  • the lower surface 12 of the contact head 10 from the portion penetrating in the vertical direction as the opening 11 in the passing direction of the needle tube 83 accompanying the movement of the injection needle toward the support mechanism 20.
  • a notch shape is provided to reach the edge.
  • a space between the two movement guide rails 22 is opened and a cut shape is provided.
  • the upper surface 13 of the contact head 10 is preferably a mortar shape or a semicircular shape recessed inward so as to constitute a magnifying glass. If the upper surface is configured with a magnifying glass, the injection site can be easily visualized. For example, even when it is difficult to view directly due to the influence of a light source or the like, it is possible to inject while visually checking the opening 11 and the needle tube 83 passing through the opening 11 by using a magnifying glass. .
  • the position corresponding to the injection point in the opening 11 on the upper surface is preferably the center of the lower surface (upper surface). Further, even if the opening 11 is a long hole, a mark 17 may be provided near the center so that the injection point can be easily changed.
  • a linear notch serving as a positioning groove 15 is formed on the side surface 14 of the contact head 10. This linear incision is used for visually recognizing the mark on the subject at the stage of injection preparation described later. Since the positioning groove 15 formed on the side surface 14 as a notch for visually recognizing the mark is linear, it is easy to align the mark and the contact head 10 in the execution procedure described later. Further, when the cut is linear, there is an advantage that the surface processing becomes easy.
  • FIG. 8 is an operation explanatory diagram of the injection device 1 according to the first embodiment.
  • FIG. 9 is an explanatory diagram of an injection operation flow according to the first embodiment. The injection operation in the first embodiment will be described with reference to FIGS. 8 and 9 below.
  • the content injection control mechanism 50 controls the needle tube 83 to withdraw the needle tube 83 from a desired depth to the subject surface at the same time that the content is injected into the subject. The following flow will be described.
  • a syringe filled with an infusion is set in an injection device. At this time, it sets to a starting position so that the pusher 88 and the press part 40 may contact. (See the implementation procedure below)
  • the contact head 10 of the injection device 1 is brought into contact with the subject S at the start.
  • each component of the injection device 1 is assumed to be in the state shown in FIG. Note that due to the shape of the lower surface of the contact head 10 shown in FIG. 7A, the tip of the needle tube 83 is positioned above the portion of the lower surface of the contact head 10 that contacts the subject before the puncture. Therefore, the tip of the needle tube 83 does not contact the subject.
  • the relative movement of the pressing portion 40 does not change the distance between the movable holder 30 and the pressing portion 40 in the puncturing operation. Therefore, it is possible to prevent air bubbles generated due to decompression of only the pusher 88 moving backward due to an increase in the distance between the movable holder 30 and the pressing portion 40. Further, since the distance between the movable holder 30 and the pressing portion 40 is shortened, it is possible to prevent only the pusher 88 from moving forward and performing the injection operation in parallel with the puncturing operation.
  • the pressing portion 40 is locked by a ratchet mechanism (FIG. 6) relative to the rod-like members 51 and 52 in the movement in the separating direction (retracting direction). That is, when the movable holder 30 moves away from the contact head 10, the pressing portion 40 is stopped together with the unfastened guide rod 51 that does not move, so that the movable holder 30 is not moved against the pressing portion 40 that does not move.
  • the interlocking rod 52 fastened to the position moves. That is, the pressing portion 40 slides toward the movable holder 30 (forward direction) with respect to the interlocking rod 52.
  • the operation by the distance D m becomes long, the distance D p that is shorter, performing the needle removal and liquid injection together (FIG. 8 (b) ⁇ (c) ).
  • the movable holder 30 moves backward, the movable holder 30 moves relative to the guide rod 51, so that the distance between the movable holder 30 and the pressing portion 40 is shortened.
  • the pusher 88 is pushed into the syringe cylinder 84, and the volume of the syringe cylinder 84 becomes small, and the inside Liquid is injected into the subject. Therefore, an appropriate amount of injection operation can be appropriately performed.
  • the injection device 1 is separated from the subject. At this time, the tip of the needle tube 83 is separated from the subject due to the shape of the lower surface of the contact head 10 in FIG.
  • the injection device 1 of the present invention appropriately holds the syringe cylinder 84 and the injection needle 81 in the movable holder 30 when the injection operation is performed.
  • the flange fitting portion 31 and the needle base stopper 33 restrict the movement of the syringe cylinder 84 and the injection needle 81 in the content injection direction.
  • the injection device of the second embodiment is preferably applied when an injection operation is performed on a very shallow place of the subject.
  • the needle moves backward (withdrawing needle) in two stages. Specifically, in conjunction with the injection operation (contents injection operation) by the pressing operation of the pusher onto the syringe barrel, the needle is retracted to a predetermined distance (needle removal operation), and then the injection operation is not performed. In addition, an operation is performed in which the needle retracts from the predetermined distance until the needle is removed from the surface of the subject.
  • FIG. 10 is an explanatory view of an injection device 2 according to the second embodiment of the present invention, in which (a) is a perspective view and (b) is a side view.
  • FIG. 11 shows an enlarged view of the needle extraction control mechanism of the injection apparatus of FIG.
  • FIG. 12 shows a perspective view of the injection device of FIG.
  • the injection device 2 of this embodiment includes a needle removal control mechanism 60.
  • the content injection control mechanism 50 controls the first-stage needle tube retraction operation in which the content is injected into the subject and the needle tube is retracted from a desired depth to a predetermined position.
  • the needle removal control mechanism 60 controls the second-stage needle tube retraction operation in which the needle tube is retracted from a predetermined position to at least the surface of the subject and the needle is removed without injecting the contents into the subject.
  • the needle removal control mechanism 60 includes a control plate 61, two position adjustment pins 62, 63, two coil springs (second elastic members) 64, 65, a lock pin 66, 67.
  • the control plate 61 includes an upper surface plate 61T and a side surface plate 61S that cover at least a part of the upper surface portion 24-1 of the support mechanism 20-1 and the side wall 23-1 on the rear end side away from the contact head 10. Prepare.
  • the two position adjustment pins (dowels) 62 and 63 have large-diameter heads and are fitted in the side plates 61S of the control plate 61.
  • the coil springs 64 and 65 which are second elastic members, are provided (externally fitted) on the outer periphery of the position adjustment pin, and are held by the side plate 61S of the control plate 61 and the support mechanism 20-1.
  • the two lock pins (elastic pins) 66 and 67 are provided on the upper surface of the support mechanism 20-1, and one end is held by the side surface (guide surface) of the circumferential surface holding portion 34-1 of the movable holder 30-1. .
  • the lock pins 66 and 67 are provided to extend in a direction substantially perpendicular to the moving direction of the syringe 80 (short direction of the syringe barrel).
  • the engagement protrusion 39 is provided on the upper surface of the peripheral surface holding portion 34-1 of the movable holder 30-1.
  • the tip of the engaging protrusion 39 has a tapered shape, and the lock pins 66 and 67 are slidably in contact with the vertical surfaces (holder side guide surfaces) 39L and 39M of the protrusion tip.
  • the support mechanism 20-1 includes an upper surface portion 24-1 and a side wall 23-1, and a guide path for guiding the movement of the movable holder 30-1 is formed therein.
  • the side wall 23-1 of the support mechanism 20-1 is opened so that a part of the movable holder 30-1 is inserted (opening 23O).
  • the shape of the support mechanism 20-1 is different from that of the first embodiment, and is a recessed shape for fitting the upper surface plate 61T of the control plate 61 into the upper surface portion 24-1 of the support mechanism 20-1.
  • a notch 26 is provided.
  • Lock pins 66 and 67 are slidably in contact with vertical surfaces (support side guide surfaces) 27L and 27M in the moving direction of the notch 26.
  • recessed portions with respect to the vertical surfaces 27L and 27M that is, grooves 28L and 28M are formed, respectively, in which the space of the notch is increased.
  • the lock pins 66 and 67 are elastic pins that can be extended and contracted, and slide along the holder side guide surfaces 39L and 39M of the movable holder 30-1 and along the grooves 61TL and 61TM cut in the upper surface plate 61T. Is possible.
  • the holder-side guide surfaces 39L and 39M are not yet in contact with the lock pins 66 and 67 in the state shown in FIG.
  • the lock pins 66 and 67 start to contact the tips of the holder side guide surfaces 39L and 39M, and then move along the holder side guide surfaces 39L and 39M (see FIG. 11, left direction).
  • the movable holder 30-1 moves with the lock pins 66 and 67 engaged with the grooves 28L and 28M (FIG. 13 (c) ⁇ FIG. 13 (d)). .
  • the outward pushing force applied to the lock pins 66 and 67 due to the shape of the holder-side guide surfaces 39L and 39M of the engaging projection 39, which is the convex portion of the movable holder 30-1, is applied.
  • the lock pins 66 and 67 and the grooves 28L and 28M are disengaged (FIG. 11B).
  • the present embodiment is not provided with side wall fixing portions 23G and 23J for fixing the guide rod 51 and the connecting rod 53 to the side wall 23-1 of the support mechanism 20-1. .
  • the pin insertion holes 23P and 23Q into which the position adjusting pins 62 and 63 into which the second elastic members 64 and 65 are fitted to the outside are movably inserted are opened.
  • the side plate 61S of the control plate 61 is opened so that a part of the movable holder 30-1 is inserted.
  • the distal end of the guide rod 51-1 and the distal end of the connecting rod 53-2 are fixed to the side plate 61S of the control plate 61.
  • the side plate 61S is provided with a side fixing portion 61SG that fixes the guide rod 51 and a side fixing portion 61SJ that fixes the interlocking rod 52 (see FIG. 12).
  • the side plate 61S of the control plate 61 has side plate pin insertion holes 61SP and 61SQ into which the position adjusting pins 62 and 63 into which the second elastic members 64 and 65 are fitted are movably inserted. It is open.
  • the side plate 61S of the control plate 61 comes into contact with the side wall 23-1 of the support mechanism 20-1.
  • the movable holder 30-1 is retracted while the side plate 61S of the control plate 61 is in contact with the side wall 23-1 of the support mechanism 20-1.
  • the side plate 61S of the control plate 61 moves away from the side wall 23-1 of the support mechanism 20-1, and the movable holder 30-1 retracts.
  • FIG. 13 is an operation explanatory diagram of an injection operation according to the second embodiment.
  • FIG. 15 is an explanatory diagram of an injection operation flow according to the second embodiment. The injection operation in the second embodiment will be described below with reference to FIGS. 13 and 14.
  • the injection point and the mark are marked on the subject using the injection template 100 (see FIG. 16), and then the syringe 80 (see FIG. 3) is set in the injection device 2.
  • the contact head 10-1 of the injection device 2 is brought into contact with the subject.
  • the lock pins 66 and 67 engage with the grooves 28L and 28M of the support mechanism 20.
  • the position adjustment pins 62 and 63 and the control plate 61 move in the direction of the abutting head 10-1 (forward movement direction) in a state where the lock pins 66 and 67 are fitted in the grooves of the support mechanism 20-1.
  • the distance D L is shortened (becomes zero) while the distance D M remains zero and the distance D P remains unchanged, and a compressive force is applied to the second elastic members 64 and 65 (FIG. 13). (B) ⁇ (c)).
  • the syringe barrel 84 and the injection needle 81 are appropriately held in the movable holder 30-1.
  • the flange fitting portion 31 and the needle base stopper 33 restrict displacement of the syringe barrel 84 and the injection needle 81 in the moving direction when the contents are injected.
  • the needle moves backward in two stages, so that the needle is removed after the injection operation is completed. Therefore, when a very small amount of valuable contents such as cells are injected into a very shallow place of the subject, the injection operation can be performed without overflowing the injected content from the surface of the subject.
  • the syringe 80 is taken out of the package, and the injection solution is filled into the syringe cylinder 85.
  • the button 42h at the rear end of the pressing portion 40 is pushed and slid to the rearmost end opposite to the contact head 10 (FIG. 16A).
  • Injecting device 1 while taking care not to bring the needle tip (the tip of the needle tube) into contact with the main body 10, 20 of the injection device 1, etc.
  • the movable holder 30 is attached. Specifically, as shown in FIG. 16B, the syringe 80 is inserted obliquely from the needle tip, and the flange (wing) 86 of the syringe barrel 84 is raised and pushed horizontally (FIGS. 16C and 16D). Then, the flange 86 is rotated to engage with the flange fitting portion 31 (FIG. 16 (e)). Thereafter, the pressing portion 40 of the injection device 1 is slowly moved until it comes into contact with the head 88h of the pusher 88 to complete the preparation. (FIG. 16 (f), FIG. 16 (g)).
  • the movable holder 30 is manually pushed into the contact head 10 side, and the needle tube 83 of the injection needle 81 that moves together with the movable holder 30 is punctured into the scalp (corresponding to S1 in FIG. 8).
  • the needle tube 83 is punctured into the scalp by visually recognizing the elongated hole-like opening 11 at the center of the contact head 10.
  • the preparation is injected into the scalp by slowly releasing the hand from the movable holder 30 of the injection device 1 (corresponding to S2 in FIG. 8). Then, after the injection operation is completed, the injection device 1 is separated from the scalp (corresponding to END in FIG. 8).
  • the oil pen on the skin and the groove 15 provided around the contact head 10 are aligned in different directions and the above injection operation is repeated. By repeating this at 6 locations with the injection marks, a total of 1.0 mL of the test preparation is injected when a 1 mL syringe is used.
  • the injection device 84 is removed from the syringe 84 and the needle 81, discarded, cleaned and maintained, and packed in a separate sterilization bag for sterilization.
  • Sterilization can be any of autoclave, EO gas, gamma ray sterilization, and the like.
  • the syringe 84 and the injection needle 81 are kept connected in the injection devices 1 and 2 during the period of performing the injection operation, the contents are mostly inside the injection devices 1 and 2. It is thought that it will not leak. Accordingly, it is sufficient for the cleaning and sterilization process to be performed with a focus on the lower surface 12 of the contact head 10, and the injection device to which the syringe is attached as compared with the conventional injection device in which the syringe barrel is expected to be attached and detached. There is little need to consider the contamination inside.
  • the content (substance) used in the injection device according to the above-described embodiment of the present invention is selected from the group consisting of a cell suspension, a gel material, a therapeutic substance, a cosmetic substance, and a diagnostic substance. sell.
  • the content (substance) used in the injection device can be selected from the group consisting of cell suspensions, gel-like materials, therapeutic substances, cosmetic substances, and diagnostic substances.
  • the cosmetic substance to be injected may include, but is not limited to, fat cells such as filler, hyaluronic acid, or botulinum toxin (Botox, Btx) in acupuncture.
  • the therapeutic agent may include, but is not limited to, antibiotics, anesthetics, analgesics, vaccines, antibodies.
  • the injection device of the present invention may be used for injecting cells in a suspension or cells in a liquid medium into a subject as contents contained in a syringe.
  • a cell suspension may be mixed with a growth factor as the contents contained in the syringe.
  • the cell suspension may contain a gel structure.
  • a gel-like structure preferably represents a mixture of extracellular matrix proteins that mimic the extracellular environment of separate tissues, more preferably a gel-like structure such as hyaluronic acid.
  • the injection device according to the embodiment of the present invention may be used to inject a substance into a separate tissue of a subject.
  • the injection device is used to inject cells into the skin as a cell suspension in the treatment of hair loss, alopecia such as alopecia areata, or other conditions associated with hair loss or too little hair Can be.
  • the injection device of the present invention is preferably used for injecting a liquid such as a drug, cytokine, or growth factor into a subject.
  • a liquid such as a drug, cytokine, or growth factor
  • This application of the liquid to the subject is preferably done in connection with the treatment of hair loss, alopecia such as alopecia areata, or other conditions associated with hair loss or too little hair.
  • the injection device according to the embodiment of the present invention may be used for injecting a substance into the subject's muscle or injecting a substance into the subject's tendon.
  • the subject to which the injection device according to the embodiment of the present invention is applied is not limited to a human (subject), and may be an animal such as a fish or a mouse.
  • the subject may be a tissue such as a skin or an organ taken out from the subject or the test subject animal.

Abstract

An injection device 1 for injecting contents into a subject by means of a syringe, which is provided with a plunger, a barrel into which the plunger is inserted, and a needle comprising a needle hub that connects to the barrel and a shaft that is inserted into a subject, is provided with: a contact head 10 that can make contact with the subject, and has an opening formed therein through which the needle passes; a movable holder 30 that holds the barrel and the needle; a support mechanism 20 that is fixed to the contact head; and a content injection control mechanism 50 that pushes the plunger inside the barrel. The barrel and the needle are made to move with respect to the contact head as a result of the movable holder moving along the support mechanism. The syringe can be attached to and detached from the injection device.

Description

注射装置Injection device
 本発明は、注射装置に関し、より具体的には、細胞を含む様々の物質を組織内に注射し、供給し、或いは投与するのに適した装置に関する。 The present invention relates to an injection device, and more specifically to a device suitable for injecting, supplying, or administering various substances including cells into a tissue.
 細胞治療等において、細胞等の所定の物質を、皮膚内の治療部位に、精密に、所望の量を、所定の深さで、被験者に注射することが望ましいことがある。 In cell therapy or the like, it may be desirable to inject a predetermined substance such as a cell into a treatment site in the skin precisely and in a desired amount at a predetermined depth.
 さらに、微量な量の細胞等の物質を、単一の層又は単一の領域内に注入するとき、所定の量を複数回に分割して、複数の異なる方向から分散的に注入することが必要となる。 Furthermore, when a small amount of a substance such as a cell is injected into a single layer or a single region, a predetermined amount may be divided into multiple times and distributed in a plurality of different directions. Necessary.
 また、上記所定の量の内容物を複数回に分割して、複数の異なる方向から分散的に注入する場合、被検体への影響が等分割されていることが望ましく、分割された複数回において、毎回、所定の同じ速度で注入されることが望まれることがある。 In addition, when the predetermined amount of content is divided into a plurality of times and injected in a distributed manner from a plurality of different directions, it is desirable that the influence on the subject is equally divided. It may be desired to be injected at the same predetermined rate each time.
 このような問題を解決するため、注射装置内に注射針を固定する注射針ハウジングが設けられており、注射針が内部に固定されており、固定された注射針に注射筒を着脱自在に取り付けられる、特許文献1が提案されている。この注射装置では、内部の駆動システム及び後退システムにより、所定の速度で注入動作を行う。 In order to solve such a problem, an injection needle housing for fixing the injection needle is provided in the injection device, the injection needle is fixed inside, and the syringe barrel is detachably attached to the fixed injection needle. Patent Document 1 is proposed. In this injection apparatus, an injection operation is performed at a predetermined speed by an internal drive system and a retraction system.
特表2015−505487号公報JP-T-2015-505487
 しかし、特許文献1の技術では、注射針が内部に固定されているため、複数の患者又は被験者に、この装置を用いて注射を実施する場合、伝染病、感染症等の感染及び注射針の摩耗等による穿刺痛のリスクが高いことから、注射装置自体を使い捨てにする必要があった。 However, in the technique of Patent Document 1, since the injection needle is fixed inside, when injection is performed on a plurality of patients or subjects using this device, infection such as infectious diseases, infectious diseases, and the injection needle Since the risk of puncture pain due to wear or the like is high, it is necessary to make the injection device itself disposable.
 さらに、対象となる注射装置と、注射器用の注射針とが着脱できずに一体化している構造では、装置はより高度な医療機器として取り扱われることがあり、装置の届出や搬送が厳格化するおそれがあった。 Furthermore, in the structure in which the target injection device and the injection needle for the syringe are integrated without being attached or detached, the device may be handled as a more advanced medical device, and the notification and conveyance of the device become strict. There was a fear.
 また、注射による注入する内容物として粘性の高いゲル状構造の物質を用いると、使用時に高い圧力がかかり、固定された注射針に対して注射筒が外れてしまうことがあった。 In addition, when a substance having a gel-like structure with high viscosity is used as a content to be injected by injection, a high pressure is applied during use, and the syringe barrel may come off with respect to the fixed injection needle.
 そこで、本発明は上記事情に鑑み、使用時に注射筒から注射針の脱落を防ぎ、注射器を脱着できる注射装置の提供を目的とする。 Therefore, in view of the above circumstances, the present invention aims to provide an injection device that prevents the injection needle from falling off from the syringe barrel during use and can be attached to and detached from the syringe.
 本発明の一態様によれば、押し子、該押し子が挿嵌される注射筒、及び該注射筒に連結される針基と被検体内へ穿刺される針管からなる注射針を備える注射器によって、前記被検体に内容物を注入させる注射装置は、前記被検体と当接可能であり、前記針管が通る開口部が形成された当接ヘッドと;前記注射筒及び前記注射針を保持する可動ホルダーと;前記当接ヘッドに固定される支持機構と;前記押し子を前記注射筒の内部へ押し込む内容物注入制御機構と;を備えており、前記可動ホルダーが前記支持機構に沿って移動することで、前記注射筒及び前記注射針を、前記当接ヘッドに対して移動させ、前記注射器は、当該注射装置に対して着脱可能であることを特徴とする。 According to one aspect of the present invention, there is provided a syringe including a pusher, a syringe barrel into which the pusher is inserted, and a needle base connected to the syringe barrel and a needle tube punctured into a subject. An injection device for injecting contents into the subject is capable of contacting the subject and has a contact head formed with an opening through which the needle tube passes; a movable holding the syringe barrel and the injection needle A holder; a support mechanism fixed to the abutment head; and a content injection control mechanism for pushing the pusher into the syringe barrel, and the movable holder moves along the support mechanism. Thus, the syringe barrel and the injection needle are moved relative to the contact head, and the syringe is detachable from the injection device.
 本発明の一態様によれば、注射装置は、使用時に注射筒から注射針の脱落を防ぎ、注射器を脱着できる。 According to one aspect of the present invention, the injection device can prevent the syringe needle from falling off from the syringe barrel and remove the syringe during use.
本発明の第1実施形態の注射装置の説明図。Explanatory drawing of the injection apparatus of 1st Embodiment of this invention. 本発明の注射装置に適用される注射器の構成図。The block diagram of the syringe applied to the injection apparatus of this invention. 図1の注射装置における可動ホルダーの説明図。Explanatory drawing of the movable holder in the injection device of FIG. 図1の注射装置における可動ホルダーと支持機構の説明図。Explanatory drawing of the movable holder and support mechanism in the injection device of FIG. 図4に示す可動ホルダーの下面にある移動機構及び棒状部材の説明図。Explanatory drawing of the moving mechanism and rod-shaped member in the lower surface of the movable holder shown in FIG. 図1の注射装置における押圧部におけるラチェット機構の説明図。Explanatory drawing of the ratchet mechanism in the press part in the injection device of FIG. 図1の注射装置における当接ヘッドの説明図。Explanatory drawing of the contact head in the injection apparatus of FIG. 本発明の第1実施形態に係る注射装置の動作説明図。Operation | movement explanatory drawing of the injection apparatus which concerns on 1st Embodiment of this invention. 第1実施形態に係る注射動作フローの説明図。Explanatory drawing of the injection operation | movement flow which concerns on 1st Embodiment. 本発明の第2実施形態の注射装置。The injection apparatus of 2nd Embodiment of this invention. 図10の注射装置の抜針制御機構の拡大図。FIG. 11 is an enlarged view of a needle extraction control mechanism of the injection device of FIG. 10. 図10の注射装置の透視斜視図。FIG. 11 is a perspective view of the injection device of FIG. 10. 本発明の第1実施形態に係る注射装置の動作説明図。Operation | movement explanatory drawing of the injection apparatus which concerns on 1st Embodiment of this invention. 第2実施形態に係る注射動作フローの説明図。Explanatory drawing of the injection operation | movement flow which concerns on 2nd Embodiment. 注射用テンプレートを用いて被検体に印付けを行う場合の説明図。Explanatory drawing in the case of marking a subject using a template for injection. 注射器の取付け手順の説明図。Explanatory drawing of the attachment procedure of a syringe. 注射器が装着された注射装置と被検体に注射装置を当接させた図。The figure which made the injection apparatus contact | abut to the injection device with which the injection device was mounted | worn, and a test object.
 図1は、本願の第1実施形態の注射装置の説明図である。(a)は見取り図であり、(b)は、側面図である。 FIG. 1 is an explanatory diagram of the injection device according to the first embodiment of the present application. (A) is a sketch and (b) is a side view.
 [全体説明]
注射装置1は、被検体(人間、動物、個別の臓器、皮膚等)に細胞懸濁液などの物質を含む内容物を注入する注射器が装着される注射装置である。注射装置1は、注射器を用いて適量の内容物を被検体へ注入するための、注入用シリンジホルダー(注射器ホルダー)として機能する。
[Overall description]
The injection device 1 is an injection device to which a syringe that injects a content containing a substance such as a cell suspension into a subject (human, animal, individual organ, skin, etc.) is attached. The injection device 1 functions as an injection syringe holder (injector holder) for injecting an appropriate amount of contents into a subject using a syringe.
 注射装置は、当接ヘッド10と、支持機構20と、可動ホルダー30と、内容物注入制御機構50とを備えている。 The injection device includes a contact head 10, a support mechanism 20, a movable holder 30, and a content injection control mechanism 50.
 当接ヘッド10は、被検体と当接可能であり、開口部が形成されている。当接ヘッド10は、注射装置1の先端に位置している。後述する針管83が被検体に対して、穿刺動作・抜針動作を行うときに、この開口部11(図4(b)参照)を通過する。 The contact head 10 can contact the subject and has an opening. The contact head 10 is located at the tip of the injection device 1. When a later-described needle tube 83 performs a puncture operation / needle extraction operation on a subject, the tube passes through the opening 11 (see FIG. 4B).
 支持機構20は、当接ヘッド10に所定の角度で固定されている。支持機構20と当接ヘッド10との結合角度により、被検体に対する注射角度を設定する。当接ヘッド10と支持機構20とは、一体化して製造されてもよいし、別々に製造後に溶接等で固着してもよい。 The support mechanism 20 is fixed to the contact head 10 at a predetermined angle. The injection angle with respect to the subject is set by the coupling angle between the support mechanism 20 and the contact head 10. The abutting head 10 and the support mechanism 20 may be integrally manufactured, or may be fixed separately by welding or the like after manufacturing.
 支持機構20は可動ホルダー30の移動の停止位置を規定して、可動ホルダー30を受け止めるホルダー受部である。 The support mechanism 20 is a holder receiving part that defines the stop position of the movement of the movable holder 30 and receives the movable holder 30.
 可動ホルダー30は、注射筒84及び注射針81(図2(a)参照)を保持し、当接ヘッド10に対して、支持機構20に沿って移動可能である。可動ホルダー30が、当接ヘッド10に対して移動することで、可動ホルダー30が保持している注射筒84及び注射針81を、当接ヘッド10と当接する被検体に対して、移動させる。この相対移動により、被検体に対して、注射器80の針管83が、穿刺する方向である前進方向、及び抜針する方向である後退方向へ移動する。 The movable holder 30 holds the syringe barrel 84 and the injection needle 81 (see FIG. 2A) and is movable along the support mechanism 20 with respect to the contact head 10. By moving the movable holder 30 relative to the contact head 10, the syringe cylinder 84 and the injection needle 81 held by the movable holder 30 are moved with respect to the subject in contact with the contact head 10. By this relative movement, the needle tube 83 of the syringe 80 moves relative to the subject in a forward direction that is a puncturing direction and a backward direction that is a direction in which the needle is removed.
 内容物注入制御機構50は、押し子88を注射筒84に対して押し込む。内容物注入制御機構は、押圧部40と、ガイド棒51と、連動棒52と、連結棒53と、弾性部材54,55とを含む(図5参照)。 The content injection control mechanism 50 pushes the pusher 88 into the syringe barrel 84. The content injection control mechanism includes a pressing portion 40, a guide rod 51, an interlocking rod 52, a connecting rod 53, and elastic members 54 and 55 (see FIG. 5).
 ここで、本発明の注射装置1において、注射筒と注射針とは注射器として着脱可能である。図2に、注射器の説明図であって、(a)に、組立て後の注射器、(b)に、注射器の分解図を示す。 Here, in the injection device 1 of the present invention, the syringe barrel and the injection needle are detachable as a syringe. FIG. 2 is an explanatory view of the syringe, wherein (a) shows the assembled syringe, and (b) shows an exploded view of the syringe.
 図2に示すように、注射器80は、注射針81と、注射筒84と、押し子88によって構成されている。注射筒(シリンダー:cylinder)84は内容物を収容し、押し子88が挿嵌される。詳しくは、注射筒84は、内容物を収容する外筒部85と、外筒部85の後端に設けられるフランジ86と、筒先87を備える。 As shown in FIG. 2, the syringe 80 includes an injection needle 81, an injection cylinder 84, and a pusher 88. A syringe cylinder (cylinder) 84 accommodates the contents, and a pusher 88 is inserted. Specifically, the syringe cylinder 84 includes an outer cylinder portion 85 that stores the contents, a flange 86 provided at the rear end of the outer cylinder portion 85, and a cylinder tip 87.
 ここで、本発明の注射装置内では、1mLの容積を備える注射器が用いられると好適である。そのような1mLの注射器は、10回の100μLの注射や6回の166μLの注射を可能にする。2、5、又は10mLを備える注射器を用いることもできる。注射装置の具体的な使用形態に依存して、注射器は、より大きい又はより小さい容積を備えていてもよい。 Here, it is preferable that a syringe having a volume of 1 mL is used in the injection device of the present invention. Such a 1 mL syringe allows for 10 100 μL injections and 6 166 μL injections. Syringes with 2, 5, or 10 mL can also be used. Depending on the specific mode of use of the injection device, the syringe may have a larger or smaller volume.
 注射針81は、注射筒84と連結される。詳しくは、注射針81は注射筒84の筒先87へ外嵌される針基82と、被検体内へ穿刺される針管83とを備えている。注射器80をセットするとき、注射針81の針基82の中に、注射筒84の筒先87を挿入して係合する。注射針81の針基82と注射筒84の筒先87が容易に外れないようにロックする構造を有する注射器を使用しても良い。 The injection needle 81 is connected to the syringe barrel 84. Specifically, the injection needle 81 includes a needle base 82 that is externally fitted to the tube tip 87 of the injection tube 84 and a needle tube 83 that is punctured into the subject. When setting the syringe 80, the tube tip 87 of the syringe tube 84 is inserted into the needle base 82 of the injection needle 81 and engaged. You may use the syringe which has a structure which locks so that the needle base 82 of the injection needle 81 and the cylinder tip 87 of the injection cylinder 84 may not remove easily.
 ここで、本発明の注射装置に適用する、注射針の針管の直径は、18~34G、20~30Gの範囲にあると好適である。また、より好ましくは、26G、27G、又は30Gである。 Here, the diameter of the needle tube of the injection needle applied to the injection device of the present invention is preferably in the range of 18 to 34G, 20 to 30G. More preferably, it is 26G, 27G, or 30G.
 押し子88(プランジャ:plunger)は、頭部(後部)88hが押圧されることにより、注射筒84の外筒部85内を移動することで、注射器から内容物が放出される。押し子88の先端部には、液漏れ防止や異物混入防止のための薄板状のゴム製のパッキン(密封素子)であるガスケット89が接着されている。 The pusher 88 (plunger) is moved in the outer cylinder part 85 of the injection cylinder 84 by pressing the head (rear part) 88h, whereby the contents are released from the syringe. A gasket 89 which is a thin rubber packing (sealing element) for preventing liquid leakage and foreign matter mixing is bonded to the tip of the pusher 88.
 ここで、本発明において、図2(a)に示すような注射筒84と注射針81とが一体化して一緒に着脱できるため、注射筒84に収容されている内容物が、注射装置1の内側に付着することがなく、あるいは極力付着を少なくして、注射装置1は再利用可能となる。ここで、注射筒84と注射針81とは、少なくとも、注射装置1への着脱のとき及び注射装置1内に搭載されているときに、連結により一体化されていればよく、注射装置1の外にあるときは、注射筒84と注射針81とは、別々の状態であってよい。 Here, in the present invention, since the syringe cylinder 84 and the injection needle 81 as shown in FIG. 2A can be integrated and detached together, the contents contained in the syringe cylinder 84 are The injection device 1 can be reused without adhering to the inside or with as little adhesion as possible. Here, the injection tube 84 and the injection needle 81 need only be integrated by connection at least when being attached to and detached from the injection device 1 and mounted in the injection device 1. When outside, the syringe tube 84 and the injection needle 81 may be in separate states.
 [可動ホルダー(注射器ホルダー)]
 図3に可動ホルダー30の上面の拡大断面図を示す。(a)は斜視図であり、(b)は(a)のA−A’で切断した断面上面図である。
[Movable holder (syringe holder)]
FIG. 3 shows an enlarged cross-sectional view of the upper surface of the movable holder 30. (A) is a perspective view, (b) is a cross-sectional top view cut along AA ′ in (a).
 可動ホルダー30は、上部に位置する、前方ホルダー310及び後方ホルダー320から構成される注射器ホルダーと、棒状部材51,52,53が通る2つの貫通孔(331,332、図5参照)が形成されている移動支持部330とを備えている。また、第1の弾性部材であるコイルばね54,55が、移動支持部330の内部に設けられている。 The movable holder 30 is formed with a syringe holder made up of a front holder 310 and a rear holder 320, and two through holes (331, 332, see FIG. 5) through which the rod-shaped members 51, 52, 53 pass. The moving support part 330 is provided. In addition, coil springs 54 and 55 which are first elastic members are provided inside the movement support portion 330.
 可動ホルダーの上部にある310,320は、フランジ嵌合部31と、外筒部挟持部32と、針基ストッパー33と、周面保持部34とを有する。 The upper part 310 and 320 of the movable holder includes a flange fitting part 31, an outer cylinder part holding part 32, a needle base stopper 33, and a peripheral surface holding part 34.
 フランジ嵌合部31は、注射筒84のフランジ86と嵌合する。フランジ嵌合部31は、図3(b)に示すように、上面視で翼形状の外枠形状であり、フランジ86をこの外枠形状に嵌め込むことで係合させている。この係合により、フランジ86の位置決めを行い、フランジ86が、可動ホルダー30に対して、離間方向(後退方向、図1(b)の矢印B方向)へ移動することを規制する。 The flange fitting part 31 is fitted with the flange 86 of the syringe barrel 84. As shown in FIG. 3B, the flange fitting portion 31 has a wing-shaped outer frame shape in a top view, and is engaged by fitting the flange 86 into the outer frame shape. By this engagement, the flange 86 is positioned, and the flange 86 is restricted from moving in the separating direction (retracting direction, arrow B direction in FIG. 1B) with respect to the movable holder 30.
 外筒部挟持部32は、注射筒84の外筒部85の位置を両側から挟んで保持する。外筒部挟持部32は、筒状の外筒部85の側面の両側に沿うように、リブ状に起立する線状突起形状である。この構造により、外筒部挟持部32は、可動ホルダー30において、外筒部85の横方向の変位、即ち横へのズレを規制する。可動ホルダー30が動いても、保持状態を安定的に維持することができる。 The outer cylinder part clamping part 32 holds the position of the outer cylinder part 85 of the injection cylinder 84 from both sides. The outer cylinder part clamping part 32 is a linear protrusion shape that stands up in a rib shape so as to extend along both sides of the side surface of the cylindrical outer cylinder part 85. With this structure, the outer cylinder part clamping part 32 regulates the lateral displacement of the outer cylinder part 85, that is, the lateral displacement in the movable holder 30. Even if the movable holder 30 moves, the holding state can be stably maintained.
 針基ストッパー33は、注射針81の針基82の、移動を規制する。図2に示す注射器の例では、針基82の先端は、所定の面形状であり、図3に示す、針基ストッパー33は、内径が縮径する(段差が設けられている)ことで、針基82の先端面と当接可能にする。 The needle base stopper 33 restricts the movement of the needle base 82 of the injection needle 81. In the example of the syringe shown in FIG. 2, the tip of the needle base 82 has a predetermined surface shape, and the needle base stopper 33 shown in FIG. 3 is reduced in inner diameter (provided with a step). The tip end surface of the needle base 82 can be contacted.
 図3(a)では、針基ストッパー33は注射器80の移動方向に対して停止させる方向に垂直に伸びており、針管83は通過するが、針基82の先端(移動方向に対して垂直面)が針基ストッパー33と当接して、注射器80の可動ホルダー30に対する移動が規制させる構成である。なお、針基ストッパー33は、注射器80の移動方向に対して停止させる方向に垂直でなくてもよく、例えば、円周の形状を徐減させることで針基82を停止させてもよい。あるいは、針基82の先端の垂直面が存在せず、針基82の形状が、注射筒84との連結する部分に向けて、針基82の直径が徐々に太くなる場合、針基ストッパー33が、針基82の側面に当接することで、注射器80の可動ホルダー30に対する移動を規制させてもよい。 In FIG. 3A, the needle base stopper 33 extends perpendicularly to the direction of stopping the moving direction of the syringe 80 and passes through the needle tube 83, but the tip of the needle base 82 (the surface perpendicular to the moving direction). ) Is in contact with the needle base stopper 33 to restrict the movement of the syringe 80 relative to the movable holder 30. The needle base stopper 33 does not have to be perpendicular to the direction in which the syringe 80 is moved. For example, the needle base 82 may be stopped by gradually reducing the shape of the circumference. Alternatively, when there is no vertical surface at the tip of the needle base 82 and the shape of the needle base 82 gradually increases in diameter toward the portion where the needle base 82 is connected, the needle base stopper 33 However, the movement of the syringe 80 relative to the movable holder 30 may be regulated by contacting the side surface of the needle base 82.
 この構成により、注射器80を注射装置1へ装着の際、及び注入動作の最中に、針基82が、可動ホルダー30において、開口部11の側へ近接する方向(前進方向、図1(b)の矢印A方向)への移動することを規制する。 With this configuration, when the syringe 80 is attached to the injection device 1 and during the injection operation, the needle base 82 is in the direction close to the opening 11 side in the movable holder 30 (forward direction, FIG. 1B). ) In the direction of arrow A).
 周面保持部(針基周面保持部)34は、注射針81の針基82の周面を周面状に保持する。なお、周面保持部34は、さらに注射筒84の外筒部85の先端を周面状に保持してもよい。図3に示す周面保持部34は、針基82及び外筒部85の先端の周面方向に沿って全周面を覆う、筒状形状をしている。なお、周面保持部34は、全周を覆わなくてもよく、例えば針基82及び外筒部85の先端の形状に、半円状に沿うような形状であってもよい。この周面保持部34により、可動ホルダー30に対する、針基82及び外筒部の横方向の変位を規制する。この構成により、可動ホルダー30が移動したときに、保持状態の横方向(短手方向)に移動(ずれ)を防止することができる。 The peripheral surface holding portion (needle base peripheral surface holding portion) 34 holds the peripheral surface of the needle base 82 of the injection needle 81 in a peripheral shape. In addition, the peripheral surface holding part 34 may hold | maintain the front-end | tip of the outer cylinder part 85 of the injection cylinder 84 in the shape of a peripheral surface further. The circumferential surface holding portion 34 shown in FIG. 3 has a cylindrical shape that covers the entire circumferential surface along the circumferential surface direction of the tips of the needle base 82 and the outer cylindrical portion 85. The peripheral surface holding part 34 does not have to cover the entire periphery, and may be, for example, a shape that follows the shape of the tip of the needle base 82 and the outer cylinder part 85 along a semicircular shape. The circumferential surface holding portion 34 regulates lateral displacement of the needle base 82 and the outer cylinder portion with respect to the movable holder 30. With this configuration, when the movable holder 30 moves, movement (displacement) in the lateral direction (short direction) of the holding state can be prevented.
 上記のように、可動ホルダー30において、フランジ嵌合部31が、注射筒84の離間方向(図1(b)の矢印Bの後退方向)への移動を規制し、針基ストッパー33が、注射針81の近接方向(図1(b)の矢印Aの前進方向)への移動を規制することで、移動方向において、注射筒84と注射針81との結合状態が維持される。 As described above, in the movable holder 30, the flange fitting portion 31 restricts the movement of the syringe cylinder 84 in the separating direction (the backward direction of the arrow B in FIG. 1B), and the needle base stopper 33 is used for the injection. By restricting the movement of the needle 81 in the proximity direction (the forward direction of arrow A in FIG. 1B), the coupling state of the syringe barrel 84 and the injection needle 81 is maintained in the movement direction.
 したがって、可動ホルダー30とともに、注射筒84及び注射針81が移動しても、注射針81が注射筒84から外れて、内容物が注射装置1内に漏れることが防止できる。 Therefore, even when the syringe barrel 84 and the syringe needle 81 move together with the movable holder 30, it is possible to prevent the syringe needle 81 from coming off the syringe barrel 84 and leaking the contents into the syringe 1.
 なお、可動ホルダー30の外筒部挟持部32は、注射器80の外筒部85に沿った全ての部分に起立していなくてもよい。図3(a)に示すように、外筒部挟持部32の突起の一部が途切れている、平面部35を設けることで、注射器80の可動ホルダー30への嵌めこみが容易になり、注射器80の着脱時の操作性が向上する。 In addition, the outer cylinder part clamping part 32 of the movable holder 30 does not need to stand in all the parts along the outer cylinder part 85 of the syringe 80. As shown in FIG. 3A, by providing the flat surface portion 35 in which a part of the protrusion of the outer tube portion clamping portion 32 is interrupted, it is easy to fit the syringe 80 into the movable holder 30. The operability when attaching / detaching 80 is improved.
 [支持機構]
 図4及び図1(b)を用いて、支持機構20を説明する。図4の(a)は、当接ヘッド10と支持機構20の斜視図を示し、(b)は別の方向から見た斜視図を示す。(c)は、当接ヘッド10と支持機構20との注入方向から見た矢視図を示す。当接ヘッド10及び支持機構20は、移動可能な可動ホルダー30に対して、不動である固定部材(本体)として機能する。
[Support mechanism]
The support mechanism 20 is demonstrated using FIG.4 and FIG.1 (b). 4A shows a perspective view of the contact head 10 and the support mechanism 20, and FIG. 4B shows a perspective view seen from another direction. (C) shows the arrow view seen from the injection | pouring direction of the contact head 10 and the support mechanism 20. FIG. The contact head 10 and the support mechanism 20 function as a fixed member (main body) that is immovable with respect to the movable holder 30 that is movable.
 支持機構20は、当接ヘッド10に対して固定されている。当接ヘッド10と支持機構20との接続角度により、注射器80の針管83の被検体に対する接触角度が設定される。 The support mechanism 20 is fixed to the contact head 10. The contact angle of the needle tube 83 of the syringe 80 with respect to the subject is set by the connection angle between the contact head 10 and the support mechanism 20.
 注射角度を規定する、支持機構20と当接ヘッド10との間の角度は、好ましくは、10度~90度の何れであってもよいが、15度~25度の範囲内にあると、さらに、より好ましい。 The angle between the support mechanism 20 and the contact head 10 that defines the injection angle may be preferably 10 degrees to 90 degrees, but if it is within a range of 15 degrees to 25 degrees, Furthermore, it is more preferable.
 支持機構20は、上面カバー24及び側壁23を備え、支持機構20の内部には、可動ホルダー30の移動を案内する、筒状のホルダーガイド経路(挿入貫通孔)21が形成されている。ここで、支持機構20の後端に位置する側壁23に、可動ホルダー30が挿入されるホルダーガイド経路21の挿入穴の入り口である開口部23Oが形成されている。 The support mechanism 20 includes an upper surface cover 24 and a side wall 23, and a cylindrical holder guide path (insertion through hole) 21 that guides the movement of the movable holder 30 is formed inside the support mechanism 20. Here, an opening 23 </ b> O which is an entrance of an insertion hole of the holder guide path 21 into which the movable holder 30 is inserted is formed in the side wall 23 positioned at the rear end of the support mechanism 20.
 支持機構20に沿って可動ホルダー30が移動可能にする、ホルダーガイド経路21のうち、下方に位置するものは、可動ホルダー30の移動を案内する、移動案内レール22として機能する。 The lower part of the holder guide path 21 that allows the movable holder 30 to move along the support mechanism 20 functions as a movement guide rail 22 that guides the movement of the movable holder 30.
 支持機構20の下方は、横方向(注入方向)に伸長する切り込み(開口部)25が設けられている)。下部が開放されていることで、注射器80の着脱動作を行うときに、針管83の先端が注射装置1の内部に接触することを防ぐ。 (Below the support mechanism 20 is provided with a cut (opening) 25 extending in the lateral direction (injection direction)). Opening the lower portion prevents the tip of the needle tube 83 from coming into contact with the inside of the injection device 1 when the syringe 80 is attached or detached.
 本実施形態において、移動案内レール22として、可動ホルダー30の先端(少なくとも注射針81を保持する部分)を挿入させるための筒状の挿入貫通孔である、ホルダーガイド経路21の内周面下面以外の部分が、可動ホルダー30の先端(周面保持部34)の形状に沿う形状となっている。 In the present embodiment, the movement guide rail 22 is a cylindrical insertion through-hole for inserting the tip of the movable holder 30 (at least the portion holding the injection needle 81), other than the lower surface of the inner peripheral surface of the holder guide path 21. This part has a shape along the shape of the tip of the movable holder 30 (peripheral surface holding part 34).
 図4(a)及び図4(c)に示すように、支持機構20では、ホルダーガイド経路21の上方、及び両側方が半円形状(かまぼこ形状)にカバーされている。詳しくは、支持機構20は、上方及び側方において少なくとも注射針81及び可動ホルダー30の注射針81を保持する部分(針基ストッパー33、周面保持部34)を、周面方向で覆う上面カバー24を備えている。従って、本実施形態では、支持機構20は、下部が開放され、可動ホルダー30をガイドするために移動方向に伸びる筒状の挿入穴であるホルダーガイド経路21が設けられているハウジング形状となっている。 As shown in FIGS. 4A and 4C, in the support mechanism 20, the upper side and both sides of the holder guide path 21 are covered in a semicircular shape (kamaboko shape). Specifically, the support mechanism 20 is an upper surface cover that covers at least a portion (the needle base stopper 33 and the peripheral surface holding portion 34) that holds the injection needle 81 and the injection needle 81 of the movable holder 30 in the upper surface and the lateral direction. 24. Therefore, in the present embodiment, the support mechanism 20 has a housing shape in which a lower portion is opened and a holder guide path 21 which is a cylindrical insertion hole extending in the moving direction to guide the movable holder 30 is provided. Yes.
 本実施形態では、支持機構20の側壁23が、可動ホルダー30の当接ヘッド10への近接方向への移動(前進移動)を停止させる。即ち、スライド移動の終止点を規定する。また、支持機構20の側壁23には、ガイド棒51の先端及び連結棒53の先端が固定(連結)されている。詳しくは、側壁23には、ガイド棒51を固定する側壁固定部23Gと、連結棒53を固定する側壁固定部23Jとが設けられている(図5参照)。側壁固定部23G、23Jは、図5に示すように、ガイド棒51、連結棒53を締めつける締結部材や、接着をする接着部材等を含んでいてもよい。 In this embodiment, the side wall 23 of the support mechanism 20 stops the movement (forward movement) of the movable holder 30 in the proximity direction to the contact head 10. That is, the end point of the slide movement is defined. Further, the front end of the guide bar 51 and the front end of the connecting bar 53 are fixed (connected) to the side wall 23 of the support mechanism 20. Specifically, the side wall 23 is provided with a side wall fixing portion 23G for fixing the guide rod 51 and a side wall fixing portion 23J for fixing the connecting rod 53 (see FIG. 5). As shown in FIG. 5, the side wall fixing portions 23G and 23J may include a fastening member for fastening the guide rod 51 and the connecting rod 53, an adhesive member for bonding, and the like.
 なお、ホルダーガイド経路を形成する筒状のハウジングは、上方が開放されていてもよい(上面カバー24が設けられていなくてもよい)。例えば、本実施形態では、支持機構20は、最低限、当接ヘッド10へ可動ホルダー30の一部(針部を保持する部分)を移動案内する、移動案内レール22と、移動の終端を規定するストッパーとなる側壁23があれば足り得る。 Note that the cylindrical housing forming the holder guide path may be open at the top (the upper surface cover 24 may not be provided). For example, in the present embodiment, the support mechanism 20 defines, at a minimum, a movement guide rail 22 that moves and guides a part of the movable holder 30 (a part that holds the needle part) to the contact head 10 and an end point of the movement. It is sufficient if there is a side wall 23 that serves as a stopper.
 ただし、図4(a)及び図4(c)に示すように本実施形態において、上面カバー24を設けることで、周面で可動ホルダー30の先端を案内することが可能になるため、より移動を安定化する効果がある。さらに/あるいは、操作者の安全面や衛生面を考慮することができる。 However, as shown in FIGS. 4A and 4C, in the present embodiment, by providing the upper surface cover 24, it is possible to guide the tip of the movable holder 30 on the peripheral surface, so that the movement is further performed. Has the effect of stabilizing. In addition, / or safety and hygiene aspects of the operator can be taken into account.
 [内容物注入制御機構]
 図5において、(a)は本発明の内容物注入制御機構50を示す分解図であり、(b)は、内容物注入制御機構50と、可動ホルダー30の下面にある移動支持部330を示す断面図である。なお、図5(b)は、図1(a)のB−B’面の断面図に相当する。
[Content injection control mechanism]
5A is an exploded view showing the content injection control mechanism 50 of the present invention, and FIG. 5B shows the content injection control mechanism 50 and the moving support portion 330 on the lower surface of the movable holder 30. FIG. It is sectional drawing. Note that FIG. 5B corresponds to a cross-sectional view of the BB ′ plane in FIG.
 本発明の実施形態の注射装置1は、内容物注入制御機構50として、押圧部40と、ガイド棒51と、連動棒52と、連結棒53と、コイルばね(第1の弾性部材)54,55を備えている。 The injection device 1 according to the embodiment of the present invention includes, as the content injection control mechanism 50, a pressing portion 40, a guide bar 51, an interlocking bar 52, a connecting bar 53, a coil spring (first elastic member) 54, 55.
 押圧部40は、可動ホルダー30が保持する注射筒84内に対して押し子88を押す。 The pressing unit 40 presses the pusher 88 against the inside of the syringe barrel 84 held by the movable holder 30.
 ガイド棒51と、連動棒52と、連結棒53とは、可動ホルダー30の相対移動を制御する棒状部材である。ガイド棒51は、可動ホルダー30及び押圧部40に対して、相対移動可能に係合される。 The guide rod 51, the interlocking rod 52, and the connecting rod 53 are rod-shaped members that control the relative movement of the movable holder 30. The guide rod 51 is engaged with the movable holder 30 and the pressing portion 40 so as to be relatively movable.
 連動棒52は、可動ホルダー30に締結され、押圧部40に対し移動可能に係合される。連結棒53は、連動棒52と同一直線状に延伸し、端部(後端)が連動棒52の端部(先端)と対向して、接触・離間可能である。また、連結棒53の先端が、可動ホルダー30の内部に位置する。 The interlocking rod 52 is fastened to the movable holder 30 and is movably engaged with the pressing portion 40. The connecting rod 53 extends in the same straight line as the interlocking rod 52, and the end portion (rear end) faces the end portion (front end) of the interlocking rod 52 and can be contacted / separated. Further, the tip of the connecting rod 53 is located inside the movable holder 30.
 また、図5(b)に示すように、第1の弾性部材(コイルばね)54,55は、可動ホルダー30の内部に設けられている。 Further, as shown in FIG. 5 (b), the first elastic members (coil springs) 54 and 55 are provided inside the movable holder 30.
 図5(b)に示す可動ホルダー30の下部は、注射筒84を保持する部分の下部に設けられる移動支持部330を示す。 The lower part of the movable holder 30 shown in FIG. 5B shows a moving support part 330 provided at the lower part of the part for holding the syringe barrel 84.
 移動支持部330には、ガイド棒51がスライド可能に挿通する第1の貫通孔331と、先端に、連結棒53がスライド可能に挿入され、同一直線上の後端に連動棒52が締結される第2の貫通孔332とが形成されている。 In the movement support portion 330, a first through hole 331 through which the guide rod 51 is slidably inserted, and a connecting rod 53 is slidably inserted at the tip, and the interlocking rod 52 is fastened to the rear end on the same straight line. The second through hole 332 is formed.
 ガイド棒51及び連結棒53は、可動ホルダー30の貫通孔331,332に対して夫々移動可能である。 The guide rod 51 and the connecting rod 53 are movable with respect to the through holes 331 and 332 of the movable holder 30 respectively.
 また、連動棒52は、接着部材38により、可動ホルダー30の貫通孔332に所定の位置で固定されている。 The interlocking rod 52 is fixed to the through hole 332 of the movable holder 30 at a predetermined position by the adhesive member 38.
 可動ホルダー30が当接ヘッド10への近接方向へ移動すると、第1の弾性部材に対して、ガイド棒51及び連結棒53から、可動ホルダー30の内部に設けられたコイルばね(第1の弾性部材)54,55に圧縮力が印加される。 When the movable holder 30 moves in the proximity direction to the contact head 10, a coil spring (first elastic member) provided in the movable holder 30 from the guide rod 51 and the connecting rod 53 with respect to the first elastic member. Compressive force is applied to the members 54, 55.
 押圧部40は、ガイド棒51と連動棒52に、係合されている。押圧部40は、押し子88の頭部(後端部)88hと当接し、相対移動により押し子88を押し込む、押し子押し部である。可動ホルダー30に設けられたコイルばね54,55の復元力により、可動ホルダー30と当接ヘッド10との距離、及び可動ホルダー30と押圧部40との距離が変化する。距離の変化の詳細は、図8及び図9を用いて後述する。 The pressing part 40 is engaged with the guide bar 51 and the interlocking bar 52. The pressing portion 40 is a pusher pushing portion that abuts against the head (rear end portion) 88h of the pusher 88 and pushes the pusher 88 by relative movement. The distance between the movable holder 30 and the contact head 10 and the distance between the movable holder 30 and the pressing portion 40 are changed by the restoring force of the coil springs 54 and 55 provided on the movable holder 30. Details of the change in the distance will be described later with reference to FIGS.
 ここで、可動ホルダー30を動かす距離が一定の場合、コイルばね54,55に掛かる圧縮力は一定となる。したがって、所定の量の内容物を複数回に分割して、毎回の注入量が等しい場合、可動ホルダー30の移動量が一定になることで、コイルばね54,55の圧縮力及びその後の復元力が一定になるため、毎回、同じ注入速度で注射動作を実施できる。 Here, when the moving distance of the movable holder 30 is constant, the compressive force applied to the coil springs 54 and 55 is constant. Therefore, when a predetermined amount of content is divided into a plurality of times and the injection amount is equal each time, the moving amount of the movable holder 30 becomes constant, so that the compression force and the subsequent restoring force of the coil springs 54 and 55 are obtained. Is constant, so that the injection operation can be performed at the same injection speed each time.
 可動ホルダー30の下部に設けられた、棒状部材51,52,53を通すための貫通孔331,332の内壁には、突起36,37(即ち、貫通孔331,332で径が小さい部分)が、バネ保持部材として、設けられている。 On the inner walls of the through holes 331 and 332 through which the rod-shaped members 51, 52, and 53 are provided, the protrusions 36 and 37 (that is, the portions having small diameters in the through holes 331 and 332) are provided. As a spring holding member, it is provided.
 ガイド棒51及び連結棒53は、夫々小径部と大径部が設けられている。小径部51S,53Sは、ガイド棒51及び連結棒53の伸長方向において、可動ホルダー30の中央付近に位置し、大径部51F,53Fは、可動ホルダー30の支持機構20の側(先端側)に位置する。 The guide rod 51 and the connecting rod 53 are each provided with a small diameter portion and a large diameter portion. The small diameter portions 51S and 53S are located near the center of the movable holder 30 in the extending direction of the guide rod 51 and the connecting rod 53, and the large diameter portions 51F and 53F are on the support mechanism 20 side (tip side) of the movable holder 30. Located in.
 コイルばね54,55は、ガイド棒51,53の小径部51S,53Sに、外嵌されている。コイルばね54が外嵌されたガイド棒51は、貫通孔331に内嵌されている。コイルばね55が外嵌された連結棒53と、固定された連動棒52は、貫通孔332に内嵌されている。 The coil springs 54 and 55 are fitted on the small diameter portions 51S and 53S of the guide rods 51 and 53, respectively. The guide bar 51 on which the coil spring 54 is fitted is fitted in the through hole 331. The connecting rod 53 to which the coil spring 55 is fitted and the fixed interlocking rod 52 are fitted in the through hole 332.
 コイルばね(第1の弾性部材)の、先端はガイド棒51及び連結棒53の大径部51F,53Fから小径部51S,53Sへ縮径する側面(段差部分)に保持され、後端はバネ保持部材である突起36,37の突起側面36S,37Sに保持される。 The leading end of the coil spring (first elastic member) is held by the side surface (stepped portion) of the guide rod 51 and the connecting rod 53 that is reduced in diameter from the large diameter portions 51F and 53F to the small diameter portions 51S and 53S, and the rear end is the spring. The protrusions 36 and 37, which are holding members, are held on the protrusion side surfaces 36S and 37S.
 なお、ガイド棒51および連結棒53は、コイルばね54,55が小径部51S,53Sに外嵌できるように、分割可能な構成になっている。 The guide bar 51 and the connecting bar 53 are configured to be split so that the coil springs 54 and 55 can be fitted onto the small diameter portions 51S and 53S.
 可動ホルダー30の内部において、連結棒53の終端は、径が大きくなっており、その終端の大径端部53Tが、他の部分から切り離し可能であって、例えば、ネジ溝とネジ溝等を嵌め合わせることで締結される。ここで、突起37の押圧部40側の面に連結棒53の終端の大径端部53Tと小径部53Sとの段差が接触して引っ掛かる位置が、可動ホルダー30と支持機構20との距離が、最も離れる位置となる。 Inside the movable holder 30, the end of the connecting rod 53 has a large diameter, and the large-diameter end 53T at the end can be separated from other parts. For example, a screw groove and a screw groove can be formed. Fastened by fitting. Here, the position where the step between the large-diameter end 53T and the small-diameter portion 53S at the end of the connecting rod 53 comes into contact with the surface of the protrusion 37 on the pressing portion 40 side and is caught is the distance between the movable holder 30 and the support mechanism 20. , The farthest position.
 また、ガイド棒51において、押圧部40側は、貫通孔331の径の大きさに近く、小径部51Sよりも大きく設計すると(中径部51Mを設けると)好適である。針管83を動かすようにコイルばね54,55に圧縮力が付加される際及びばねが復元する際に、後述するラチェット機構の係合の噛み合い方が変更しても、中径部51Mが貫通孔332に沿って移動するので、ガイド棒51に対して支持機構20をより滑らかな相対移動が可能となるためである。 Further, in the guide rod 51, it is preferable that the pressing portion 40 side is designed to be close to the diameter of the through hole 331 and larger than the small diameter portion 51S (provided with a medium diameter portion 51M). When compressive force is applied to the coil springs 54 and 55 so as to move the needle tube 83 and when the spring is restored, even if the engagement of the ratchet mechanism to be described later is changed, the medium diameter portion 51M remains in the through hole. This is because the support mechanism 20 can be moved relative to the guide bar 51 more smoothly because it moves along 332.
 ここで、可動ホルダー30が支持機構20から離れる距離D2(後述する距離D)は、穿刺の開始前における、連動棒52と連結棒53との距離D1に、対応する。この距離により、注射針の注射深さが設定される。 Here, the movable holder 30 is a distance away from the support mechanism 20 D2 (distance D m to be described later) is before the start of the puncture, the distance D1 between the interlocking rod 52 and connecting rod 53, the corresponding. This distance sets the injection depth of the injection needle.
 ここで、注射針81の針管83の注射深さは、0.5~5.5mmの範囲内にあると好ましく、2.0mm~3.5mmの範囲内にあるとさらに好ましい。 Here, the injection depth of the needle tube 83 of the injection needle 81 is preferably in the range of 0.5 to 5.5 mm, and more preferably in the range of 2.0 mm to 3.5 mm.
 [押圧部]
 図6は、押圧部40におけるラチェット機構の説明図である。詳しくは、押圧部40の分解図を示す。
[Pressing part]
FIG. 6 is an explanatory diagram of the ratchet mechanism in the pressing portion 40. Specifically, an exploded view of the pressing portion 40 is shown.
 ガイド棒51及び連動棒52において、押圧部40と対向可能な部分の周面には、傾きを持った係合ラック51r,52rが形成されている。 In the guide bar 51 and the interlocking bar 52, engaging racks 51r and 52r having inclinations are formed on the peripheral surface of the part that can face the pressing portion 40.
 押圧部40は、ガイド棒51及び連動棒52の係合ラックと噛み合う歯止め(板バネ)41を備えている。なお、押圧部40には、歯止めの他に、歯止め41が固定されている板ばね支持棒42と、歯止め41を覆うケース部44が設けられている。板ばね支持棒42は、押圧部40に固定された支持板45に移動自在に取り付けられている。また、歯止め41が固定されている反対側にはボタン42hが設けられており、ボタン42hと支持板との間に圧縮コイルばね43が外嵌されている。 The pressing portion 40 includes pawls (plate springs) 41 that mesh with the engagement racks of the guide bar 51 and the interlocking bar 52. In addition to the pawl, the pressing portion 40 is provided with a leaf spring support bar 42 to which the pawl 41 is fixed and a case portion 44 that covers the pawl 41. The leaf spring support rod 42 is movably attached to a support plate 45 fixed to the pressing portion 40. Further, a button 42h is provided on the opposite side to which the pawl 41 is fixed, and a compression coil spring 43 is externally fitted between the button 42h and the support plate.
 ここで、押圧部40内の歯止め41と、ガイド棒51及び連動棒52の係合ラック51r,52rとの係合構成がラチェット機構となっている。即ち、押圧部40は、ガイド棒51及び連動棒52に対して、可動ホルダー30に近づく方向に相対移動可能であり、可動ホルダー30から遠ざかる方向へ、相対的に離間方向(後退方向)への移動は、ロックされている。 Here, the engagement configuration between the pawl 41 in the pressing portion 40 and the engagement racks 51r and 52r of the guide rod 51 and the interlocking rod 52 is a ratchet mechanism. In other words, the pressing portion 40 can move relative to the guide rod 51 and the interlocking rod 52 in a direction approaching the movable holder 30, and move in a direction away from the movable holder 30 in a relatively separating direction (retracting direction). The movement is locked.
 注射器80の装着、脱着時など、押圧部40の位置のロックを解除する場合は、コイルばね43に抗して、ボタン42hを押圧することで、歯止め41と係合ラック51r,52rとの係合が解除される。詳細は、図8及び図9を用いて後述する。 When the locking of the position of the pressing portion 40 is released, such as when the syringe 80 is attached or detached, the button 42h is pressed against the coil spring 43, so that the engagement between the pawl 41 and the engagement racks 51r and 52r is achieved. The match is released. Details will be described later with reference to FIGS.
 [当接ヘッド]
 図7は、当接ヘッド10の拡大図である。図7に示すように、当接ヘッド10は、上面13と側面14と下面12とを有する。当接ヘッド10の上面13、下面12の形状は円形、馬蹄形、多角形状である。
[Contact head]
FIG. 7 is an enlarged view of the contact head 10. As shown in FIG. 7, the contact head 10 has an upper surface 13, a side surface 14, and a lower surface 12. The shape of the upper surface 13 and the lower surface 12 of the contact head 10 is circular, horseshoe-shaped, or polygonal.
 図7(a)~(c)を参照して、開口部11は当接ヘッド10の上面13と下面12とを貫通している。また、開口部11は、針が通過可能である。即ち、当接ヘッド10の開口部11は、当接ヘッド10の下面12に対して、可動ホルダー30の移動に伴い針管83が通る方向及び当接ヘッド10の上下方向の二股方向に貫通している。 7A to 7C, the opening 11 penetrates the upper surface 13 and the lower surface 12 of the contact head 10. Moreover, the needle | hook can pass through the opening part 11. FIG. That is, the opening 11 of the contact head 10 penetrates the lower surface 12 of the contact head 10 in a bifurcated direction in which the needle tube 83 passes and the vertical direction of the contact head 10 as the movable holder 30 moves. Yes.
 図7(a)の側面断面図を参照して、当接ヘッド10の下面12において、開口部11の周辺の表面12cが他の下面(例えば、下面突起12e)に対して内側に位置するように構成されている。このように下面12を構成すると、被検体に内容物を注入する際、下面12は被検体と部分的に当接し、開口部11の周辺は被検体と非接触となる。 With reference to the side cross-sectional view of FIG. 7A, the lower surface 12 of the contact head 10 is positioned such that the surface 12 c around the opening 11 is located inside the other lower surface (for example, the lower surface protrusion 12 e). It is configured. If the lower surface 12 is configured in this way, when the contents are injected into the subject, the lower surface 12 partially contacts the subject, and the periphery of the opening 11 is not in contact with the subject.
 例えば、非接触になる場合として、図7(c)に示す実施形態において、円形の当接ヘッド10の下面の縁部である円周部に、連続的に下面の表面方向に突出する下面突起12eが形成されている。開口部11の周囲を取り囲むように、円周形状の下面突起12eの頂部が被検体と当接する。なお、下面突起12eは連続的な形状に限られず、脚形状など、断続的な形状であってもよい。 For example, as a case of non-contact, in the embodiment shown in FIG. 7C, the lower surface protrusion that continuously protrudes in the surface direction of the lower surface on the circumferential portion that is the edge of the lower surface of the circular contact head 10 12e is formed. The top part of the circumferential lower surface protrusion 12e abuts on the subject so as to surround the periphery of the opening 11. The lower surface protrusion 12e is not limited to a continuous shape, and may be an intermittent shape such as a leg shape.
 このように当接ヘッド10の下面12を構成することで、開口部11の周辺と被検体との間には所定の空間が設けられることになる。従って、注射動作に伴い、被検体から漏出液や血液などの液体が流出した際に、当接ヘッド10の、開口部11の周辺の下面に液体が接触することで、下面12に液体が広がって付着することを抑制する。 By configuring the lower surface 12 of the contact head 10 in this way, a predetermined space is provided between the periphery of the opening 11 and the subject. Accordingly, when a liquid such as leaked liquid or blood flows out from the subject during the injection operation, the liquid comes into contact with the lower surface of the contact head 10 around the opening 11, so that the liquid spreads on the lower surface 12. To prevent adhesion.
 さらに、穿刺動作前及び抜針動作後、針管83の先端が、当接ヘッド10の下面12の被検体と当接する部分よりも上方に位置するように構成される。 Furthermore, the needle tube 83 is configured such that the tip of the needle tube 83 is positioned above the portion of the lower surface 12 of the contact head 10 that contacts the subject before the puncture operation and after the needle extraction operation.
 詳しくは、本発明の注射装置に適用される注射器の針管83は、穿刺前の段階で、針管83の先端が、当接ヘッド10の下面の被検体と当接する部分よりも上方に位置するように、針管83の長さを選択して使用する。 Specifically, the needle tube 83 of the syringe applied to the injection device of the present invention is such that the tip of the needle tube 83 is positioned above the portion of the lower surface of the contact head 10 that contacts the subject before the puncture. In addition, the length of the needle tube 83 is selected and used.
 例えば、注射容量は、別個の注射深さの各々の別個の注射部位で異なり得る。注射長の範囲は、注射針の後退動作中の注射経路の長さを定める。従って、注射全長は注射針の長さによって定められることが予見される。注射針の注射全長は、2.0mm~50mmであると好ましく、5.0mm~40mmの範囲内にあると、さらに好ましい。 For example, the injection volume may be different at each separate injection site at a separate injection depth. The injection length range defines the length of the injection path during the retracting operation of the injection needle. Therefore, it is foreseen that the total injection length is determined by the length of the injection needle. The total injection length of the injection needle is preferably 2.0 mm to 50 mm, and more preferably 5.0 mm to 40 mm.
 このように穿刺動作前及び抜針動作後において、注射針81の針管83の先端が被検体に接触しないことで、この注射装置が被検体から離す際に、被検体に針管83が刺さった状態で、予期しない方向へ動かしてしまうことを防止できる。したがって、注射装置の安全性が向上する。 Thus, before the puncture operation and after the needle extraction operation, the tip of the needle tube 83 of the injection needle 81 does not contact the subject, so that the subject is stuck with the needle tube 83 when the injection device is separated from the subject. Therefore, it can be prevented from moving in an unexpected direction. Therefore, the safety of the injection device is improved.
 さらに、操作において、操作時の被検体との接触の安定性を向上させるとともに、開口部11と被検体との非接触となる空間が大きくなるように、当接ヘッド10において、下面12において、側面14から突出するつば部16を設けてもよい。 Furthermore, in the operation, while improving the stability of the contact with the subject during the operation, in the contact head 10 on the lower surface 12, the space where the opening 11 and the subject are not in contact is increased. A collar portion 16 protruding from the side surface 14 may be provided.
 図7(b)を参照して、開口部11は、上面において、注入点に対応する位置から支持機構20に向かって細長く伸びる開口する長穴形状である。 Referring to FIG. 7 (b), the opening 11 has an elongated hole shape that is elongated from the position corresponding to the injection point toward the support mechanism 20 on the upper surface.
 このように、上方からみた開口部11の形状を上記のように長穴状に構成することで、注射動作を実施する際、注入方向を明確にするとともに、注射動作の操作者の針管の視認可能時間が長くなる。注入方向が明確にすることで、より目的の注入点に対して正確な位置に注入動作を実施できるようになる。また、針管の視認可能時間が長くなることで、針管83に屈曲や切断など異常があった場合に、注射動作に移行する前に、発見することができる。したがって、被検体に対して異常な注射動作を行うことを事前に防止できる。 As described above, the shape of the opening 11 seen from above is formed in the shape of a long hole as described above, so that when performing the injection operation, the injection direction is clarified and the operator's needle tube for the injection operation is visually recognized. Longer possible time. By clarifying the injection direction, the injection operation can be performed at a more accurate position with respect to the target injection point. Further, since the visible time of the needle tube becomes longer, it can be discovered before the injection operation is started when there is an abnormality such as bending or cutting in the needle tube 83. Therefore, it is possible to prevent an abnormal injection operation on the subject in advance.
 さらに、当接ヘッド10の下面12において、開口部11として、注射針の前記移動に伴う針管83の通過方向において、上下方向に貫通する部分から支持機構20に向かって当接ヘッド10の下面12の縁部に達する切り込み形状が設けられている。また、支持機構20の下部において、2本の移動案内レール22の間は開放されて、切り込み形状が設けられている。このように、支持機構20及び当接ヘッド10の下方が開放されていることで、注射器80の脱着のとき針管83がいずれかの部分に接触することを回避できる。 Further, on the lower surface 12 of the contact head 10, the lower surface 12 of the contact head 10 from the portion penetrating in the vertical direction as the opening 11 in the passing direction of the needle tube 83 accompanying the movement of the injection needle toward the support mechanism 20. A notch shape is provided to reach the edge. Further, in the lower part of the support mechanism 20, a space between the two movement guide rails 22 is opened and a cut shape is provided. As described above, since the lower portions of the support mechanism 20 and the contact head 10 are opened, the needle tube 83 can be prevented from coming into contact with any portion when the syringe 80 is detached.
 また、本実施形態において、当接ヘッド10の上面13は、拡大鏡を構成するように、すり鉢形状あるいは内側に凹んでいる半円形状などの形状であると好ましい。上面を拡大鏡で構成すると、注射の部位を視覚化しやすくなる。例えば、光源の影響等などで、直接視認しにくい場合であっても、拡大鏡を利用することで、開口部11及び開口部11を通る針管83を視認しながら、注射することが可能になる。 Further, in the present embodiment, the upper surface 13 of the contact head 10 is preferably a mortar shape or a semicircular shape recessed inward so as to constitute a magnifying glass. If the upper surface is configured with a magnifying glass, the injection site can be easily visualized. For example, even when it is difficult to view directly due to the influence of a light source or the like, it is possible to inject while visually checking the opening 11 and the needle tube 83 passing through the opening 11 by using a magnifying glass. .
 上記拡大鏡の効果を良好にするため、上面において、開口部11における注入点に対応する位置は、下面(上面)の中心であると好ましい。また、開口部11が長穴であっても、注入点がかわりやすいように、中心付近に目印17を設けてもよい。 In order to improve the effect of the magnifier, the position corresponding to the injection point in the opening 11 on the upper surface is preferably the center of the lower surface (upper surface). Further, even if the opening 11 is a long hole, a mark 17 may be provided near the center so that the injection point can be easily changed.
 また、当接ヘッド10の側面14には、位置決め溝15となる線状切り込みが形成されている。この線状の切り込みは、後述する注射の準備段階で、被検体に記した印が視認するために利用される。側面14に形成された、印を視認するための切り込みである位置決め溝15が線状であることで、後述する実施手順で示す印と当接ヘッド10の位置合わせをしやすくなる。また、切り込みが直線形状であると、表面加工が容易になる利点がある。 Further, a linear notch serving as a positioning groove 15 is formed on the side surface 14 of the contact head 10. This linear incision is used for visually recognizing the mark on the subject at the stage of injection preparation described later. Since the positioning groove 15 formed on the side surface 14 as a notch for visually recognizing the mark is linear, it is easy to align the mark and the contact head 10 in the execution procedure described later. Further, when the cut is linear, there is an advantage that the surface processing becomes easy.
 [注射動作]
 図8は、第1実施形態に係る注射装置1における動作説明図である。図9は、第1実施形態に係る注射動作フローの説明図である。下記、図8と図9とを用いて、第1実施形態における注射動作を説明する。
[Injection operation]
FIG. 8 is an operation explanatory diagram of the injection device 1 according to the first embodiment. FIG. 9 is an explanatory diagram of an injection operation flow according to the first embodiment. The injection operation in the first embodiment will be described with reference to FIGS. 8 and 9 below.
 本実施形態において、内容物注入制御機構50は、内容物を被検体に注入すると同時に
針管83を所望の深さから被検体表面まで後退させる抜針を行うように制御する。下記フローを説明する。
In this embodiment, the content injection control mechanism 50 controls the needle tube 83 to withdraw the needle tube 83 from a desired depth to the subject surface at the same time that the content is injected into the subject. The following flow will be described.
 START:注入液を充填した注射器を、注射装置へセットする。このとき、押し子88と押圧部40とが接触するように開始位置へ設定する。(後述の実施手順参照)
 前提として、開始の際、注射装置1の当接ヘッド10を被検体Sに当接させる。穿刺動作前では、この注射装置1の各構成要素は図8(a)の状態であるとする。なお、上記図7(a)に示す当接ヘッド10の下面の形状により、穿刺前の段階で、針管83の先端が、当接ヘッド10の下面の被検体と当接する部分よりも上方に位置するので、針管83の先端は被検体に当接しない。
START: A syringe filled with an infusion is set in an injection device. At this time, it sets to a starting position so that the pusher 88 and the press part 40 may contact. (See the implementation procedure below)
As a premise, the contact head 10 of the injection device 1 is brought into contact with the subject S at the start. Before the puncturing operation, each component of the injection device 1 is assumed to be in the state shown in FIG. Note that due to the shape of the lower surface of the contact head 10 shown in FIG. 7A, the tip of the needle tube 83 is positioned above the portion of the lower surface of the contact head 10 that contacts the subject before the puncture. Therefore, the tip of the needle tube 83 does not contact the subject.
 S1:操作者が手動で、可動ホルダー30を当接ヘッド10に近づける(穿刺動作)。このとき、可動ホルダー30が当接ヘッド10への近接方向(矢印に示す方向)へ移動することで、注射針81の針管83が被検体に対して近接し、被検体へ穿刺し、被検体の内部へと前進する(進入する)。ここで、可動ホルダー30内に設けられたコイルバネ(第1の弾性部材)54,55が圧縮される。 S1: The operator manually brings the movable holder 30 close to the contact head 10 (puncture operation). At this time, the movable holder 30 moves in the proximity direction to the contact head 10 (the direction indicated by the arrow), so that the needle tube 83 of the injection needle 81 comes close to the subject and punctures the subject. Move forward into (enter). Here, the coil springs (first elastic members) 54 and 55 provided in the movable holder 30 are compressed.
 詳しくは、可動ホルダー30に締結された連動棒52とともに、押圧部40は、可動ホルダー30と所定の距離Dを保ったまま、当接ヘッド10へ近づく方向へ移動し、距離Dが短くなる(ゼロになる)(図8(a)⇒図8(b))。ここで、可動ホルダー30と締結された連動棒52が、可動ホルダー30と一緒に移動するため、押圧部40と連動棒52の終端も一緒に移動する。 Specifically, with interlocking rod 52 fastened to the movable holder 30, the pressing portion 40, while keeping the movable holder 30 a predetermined distance D p, and moved in the direction approaching to the contact head 10, the distance D m is short (Becomes zero) (FIG. 8 (a) → FIG. 8 (b)). Here, since the interlocking rod 52 fastened with the movable holder 30 moves together with the movable holder 30, the pressing portion 40 and the end of the interlocking rod 52 also move together.
 また、動かないガイド棒51に対して、押圧部40が移動するため、ガイド棒51と押圧部40との嵌合部分が相対的に前進方向(可動ホルダー30側)へスライドする。 Also, since the pressing portion 40 moves relative to the guide rod 51 that does not move, the fitting portion between the guide rod 51 and the pressing portion 40 slides relatively in the forward direction (movable holder 30 side).
 この押圧部40の相対移動により、穿刺動作において、可動ホルダー30と押圧部40との距離が変わらない。したがって、可動ホルダー30と押圧部40の距離が長くなることで押し子88だけが後退することの減圧により発生する気泡が混入すること防止される。また、可動ホルダー30と押圧部40の距離が短くなることで押し子88だけが前進して穿刺動作と並行して注入動作が行われることが防止される。 The relative movement of the pressing portion 40 does not change the distance between the movable holder 30 and the pressing portion 40 in the puncturing operation. Therefore, it is possible to prevent air bubbles generated due to decompression of only the pusher 88 moving backward due to an increase in the distance between the movable holder 30 and the pressing portion 40. Further, since the distance between the movable holder 30 and the pressing portion 40 is shortened, it is possible to prevent only the pusher 88 from moving forward and performing the injection operation in parallel with the puncturing operation.
 S2において、操作者が可動ホルダー30から手を離すことで、当接ヘッド10からの離間方向へ移動すると、針管が被検体の内部から後退し、被検体から抜針し、被検体から離間する。 In S <b> 2, when the operator removes his / her hand from the movable holder 30 and moves in the direction away from the contact head 10, the needle tube retracts from the inside of the subject, removes the needle from the subject, and moves away from the subject. .
 詳しくは、可動ホルダー30に付与される前進方向の力が開放されると、可動ホルダー30に設けられた、コイルばね(第1の弾性部材)54の復元力により、可動ホルダー30が、支持機構20から離れる方向へ移動する。 Specifically, when the forward force applied to the movable holder 30 is released, the movable holder 30 is supported by the restoring force of the coil spring (first elastic member) 54 provided on the movable holder 30. Move away from 20
 ここで、押圧部40は、棒状部材51,52に対して、相対的に離間方向(後退方向)への移動は、ラチェット機構(図6)により、ロックされている。即ち、可動ホルダー30が当接ヘッド10から離れる方向へ動くと、押圧部40は動かない未締結のガイド棒51と一緒に停止しているため、動かない押圧部40に対して、可動ホルダー30に締結された連動棒52が位置移動する。即ち、押圧部40は、連動棒52に対して嵌合部分が可動ホルダー30側(前進方向)へスライドする。 Here, the pressing portion 40 is locked by a ratchet mechanism (FIG. 6) relative to the rod- like members 51 and 52 in the movement in the separating direction (retracting direction). That is, when the movable holder 30 moves away from the contact head 10, the pressing portion 40 is stopped together with the unfastened guide rod 51 that does not move, so that the movable holder 30 is not moved against the pressing portion 40 that does not move. The interlocking rod 52 fastened to the position moves. That is, the pressing portion 40 slides toward the movable holder 30 (forward direction) with respect to the interlocking rod 52.
 この動作により距離Dが長くなり、距離Dが短くなることで、抜針と液体注入とを一緒に行う(図8(b)⇒(c))。可動ホルダー30の後退動作に伴って、可動ホルダー30が、ガイド棒51に対して位置移動することで、可動ホルダー30と押圧部40との距離が短くなる。押圧部40と可動ホルダー30との間の距離が短くなるとき(D⇒D’)に、押し子88が、注射筒84に対して押し込まれ、注射筒84の容積が狭くなり、内部の液体が被検体へ注入される。従って、適切に適量な量の注入動作が実施されうる。 The operation by the distance D m becomes long, the distance D p that is shorter, performing the needle removal and liquid injection together (FIG. 8 (b) ⇒ (c) ). As the movable holder 30 moves backward, the movable holder 30 moves relative to the guide rod 51, so that the distance between the movable holder 30 and the pressing portion 40 is shortened. When the distance between the pressing part 40 and the movable holder 30 is shortened (D p ⇒D p ′), the pusher 88 is pushed into the syringe cylinder 84, and the volume of the syringe cylinder 84 becomes small, and the inside Liquid is injected into the subject. Therefore, an appropriate amount of injection operation can be appropriately performed.
 END;注射装置1を被検体から離す。このとき、上記図7(a)の当接ヘッド10の下面の形状により、針管83の先端は被検体から離れている。 END: The injection device 1 is separated from the subject. At this time, the tip of the needle tube 83 is separated from the subject due to the shape of the lower surface of the contact head 10 in FIG.
 上記構成及びフローにより、本発明の注射装置1は注入動作が行われる際に、可動ホルダー30において注射筒84及び注射針81が適切に保持されている。特に、フランジ嵌合部31と針基ストッパー33により、内容物注入方向の注射筒84及び注射針81の移動が規制されている。 With the above configuration and flow, the injection device 1 of the present invention appropriately holds the syringe cylinder 84 and the injection needle 81 in the movable holder 30 when the injection operation is performed. In particular, the flange fitting portion 31 and the needle base stopper 33 restrict the movement of the syringe cylinder 84 and the injection needle 81 in the content injection direction.
 したがって、注射による注入する内容物として、粘性の高いゲル状構造の物質を用いた場合で、使用時に注射筒に高い圧力がかかったとしても、注射針と注射筒との連結状態は解消されない。よって、注射装置1により、精密な注射動作が実現できる。 Therefore, even when a highly viscous gel-like substance is used as the contents to be injected by injection, even if a high pressure is applied to the syringe barrel during use, the connection state between the syringe needle and the syringe barrel is not canceled. Therefore, a precise injection operation can be realized by the injection device 1.
 <第2実施形態>
 次に、第2実施形態について説明する。第2実施形態の注射装置は、被検体のごく浅い場所に対して注射動作を行う場合に適用されると好ましい。
Second Embodiment
Next, a second embodiment will be described. The injection device of the second embodiment is preferably applied when an injection operation is performed on a very shallow place of the subject.
 第2実施形態の注射装置では、穿刺動作後、針の後退移動(抜針動作)が2段階で行われる。詳しくは、押し子の注射筒への押圧動作による注射動作(内容物射出動作)と連動して、所定の距離まで針が後退する(針抜動作)が行われ、その後、注射動作を行わずに、該所定の距離から被検体の表面から抜けるまで針が後退する動作が行われる。 In the injection device according to the second embodiment, after the puncturing operation, the needle moves backward (withdrawing needle) in two stages. Specifically, in conjunction with the injection operation (contents injection operation) by the pressing operation of the pusher onto the syringe barrel, the needle is retracted to a predetermined distance (needle removal operation), and then the injection operation is not performed. In addition, an operation is performed in which the needle retracts from the predetermined distance until the needle is removed from the surface of the subject.
 図10は、本発明の第2実施形態の注射装置2の説明図であって、(a)に斜視図、(b)に側面図を示す。図11は、図10の注射装置の抜針制御機構の拡大図を示す。図12に図10の注射装置の透視斜視図を示す。 FIG. 10 is an explanatory view of an injection device 2 according to the second embodiment of the present invention, in which (a) is a perspective view and (b) is a side view. FIG. 11 shows an enlarged view of the needle extraction control mechanism of the injection apparatus of FIG. FIG. 12 shows a perspective view of the injection device of FIG.
 図10~図12に示すように、本実施形態の注射装置2は、抜針制御機構60を備えている。本実施形態において、内容物注入制御機構50は、内容物を被検体に注入すると同時に、針管を所望の深さから所定の位置まで後退させる一段階目の針管後退動作を制御する。抜針制御機構60は、内容物を被検体へ注入せずに、針管を所定の位置から、少なくとも被検体の表面まで後退させ、抜針させる二段階目の針管後退動作を制御する。 As shown in FIG. 10 to FIG. 12, the injection device 2 of this embodiment includes a needle removal control mechanism 60. In the present embodiment, the content injection control mechanism 50 controls the first-stage needle tube retraction operation in which the content is injected into the subject and the needle tube is retracted from a desired depth to a predetermined position. The needle removal control mechanism 60 controls the second-stage needle tube retraction operation in which the needle tube is retracted from a predetermined position to at least the surface of the subject and the needle is removed without injecting the contents into the subject.
 図11を参照して、抜針制御機構60は、制御プレート61と、2本の位置調整ピン62,63と、2つのコイルばね(第2の弾性部材)64,65と、ロックピン66,67とを備えている。 Referring to FIG. 11, the needle removal control mechanism 60 includes a control plate 61, two position adjustment pins 62, 63, two coil springs (second elastic members) 64, 65, a lock pin 66, 67.
 制御プレート61は、支持機構20−1の少なくとも一部の上面部24−1と、当接ヘッド10とは離れた後端側の側壁23−1とを覆う、上面板61T及び側面板61Sを備える。 The control plate 61 includes an upper surface plate 61T and a side surface plate 61S that cover at least a part of the upper surface portion 24-1 of the support mechanism 20-1 and the side wall 23-1 on the rear end side away from the contact head 10. Prepare.
 2本の位置調整ピン(ダボ)62,63は、大径の頭部を備え、制御プレート61の側面板61Sに嵌めこまれている。 The two position adjustment pins (dowels) 62 and 63 have large-diameter heads and are fitted in the side plates 61S of the control plate 61.
 第2の弾性部材であるコイルばね64,65は、位置調整ピンの外周に設けられ(外嵌され)、制御プレート61の側面板61Sと、支持機構20−1に保持されている。 The coil springs 64 and 65, which are second elastic members, are provided (externally fitted) on the outer periphery of the position adjustment pin, and are held by the side plate 61S of the control plate 61 and the support mechanism 20-1.
 2つのロックピン(弾性ピン)66,67は、支持機構20−1の上面に設けられ、一端が可動ホルダー30−1の周面保持部34−1の側面(ガイド面)に保持されている。また、ロックピン66,67は、注射器80の移動方向に対して略垂直の方向(注射筒の短手方向)に伸長して設けられている。 The two lock pins (elastic pins) 66 and 67 are provided on the upper surface of the support mechanism 20-1, and one end is held by the side surface (guide surface) of the circumferential surface holding portion 34-1 of the movable holder 30-1. . The lock pins 66 and 67 are provided to extend in a direction substantially perpendicular to the moving direction of the syringe 80 (short direction of the syringe barrel).
 また、また本実施形態では、可動ホルダー30−1の周面保持部34−1の上面に、係合用突起39が設けられている。係合用突起39の先端部は先細り形状となっており、突起先端の垂直面(ホルダー側ガイド面)39L,39Mに対して、ロックピン66,67がスライド可能に当接している。 Further, in the present embodiment, the engagement protrusion 39 is provided on the upper surface of the peripheral surface holding portion 34-1 of the movable holder 30-1. The tip of the engaging protrusion 39 has a tapered shape, and the lock pins 66 and 67 are slidably in contact with the vertical surfaces (holder side guide surfaces) 39L and 39M of the protrusion tip.
 支持機構20−1は、上面部24−1及び側壁23−1を備え、可動ホルダー30−1の移動を案内するガイド経路が内部に形成されている。第1実施形態と同様に支持機構20−1の側壁23−1は、可動ホルダー30−1の一部が挿入されるように開口されている(開口部23O)。 The support mechanism 20-1 includes an upper surface portion 24-1 and a side wall 23-1, and a guide path for guiding the movement of the movable holder 30-1 is formed therein. As in the first embodiment, the side wall 23-1 of the support mechanism 20-1 is opened so that a part of the movable holder 30-1 is inserted (opening 23O).
 ここで、第1実施形態とは支持機構20−1の形状が異なり、支持機構20−1の上面部24−1に、制御プレート61の上面板61Tを嵌め込むために凹んだ形状である、切欠け部26が設けられている。切欠け部26の移動方向の垂直面(支持側ガイド面)27L,27Mに対して、ロックピン66,67がスライド可能に当接している。 Here, the shape of the support mechanism 20-1 is different from that of the first embodiment, and is a recessed shape for fitting the upper surface plate 61T of the control plate 61 into the upper surface portion 24-1 of the support mechanism 20-1. A notch 26 is provided. Lock pins 66 and 67 are slidably in contact with vertical surfaces (support side guide surfaces) 27L and 27M in the moving direction of the notch 26.
 さらに、垂直面27L,27Mに対して凹む部分、即ち、切欠けの空間が大きくなる、溝部28L,28Mが夫々形成されている。 Further, recessed portions with respect to the vertical surfaces 27L and 27M, that is, grooves 28L and 28M are formed, respectively, in which the space of the notch is increased.
 ロックピン66,67は、伸縮可能な弾性ピンであり、可動ホルダー30−1のホルダー側ガイド面39L,39Mに沿って、及び上面板61Tに刻まれた溝61TL,61TMに沿って、スライド移動可能である。 The lock pins 66 and 67 are elastic pins that can be extended and contracted, and slide along the holder side guide surfaces 39L and 39M of the movable holder 30-1 and along the grooves 61TL and 61TM cut in the upper surface plate 61T. Is possible.
 注射動作を行う際、後述する図13(a)の状態では、ホルダー側ガイド面39L,39Mは、まだ、ロックピン66,67と接触していない。この状態で、可動ホルダー30−1を動かすと、ロックピン66,67は、ホルダー側ガイド面39L,39Mの先端に接触し始めた後、ホルダー側ガイド面39L,39Mに沿って移動する(図11、左方向)。 When performing the injection operation, the holder-side guide surfaces 39L and 39M are not yet in contact with the lock pins 66 and 67 in the state shown in FIG. When the movable holder 30-1 is moved in this state, the lock pins 66 and 67 start to contact the tips of the holder side guide surfaces 39L and 39M, and then move along the holder side guide surfaces 39L and 39M (see FIG. 11, left direction).
 そして、図13(b)の状態になる直前に、可動ホルダー30の凸部である係合用突起39の形状により、ロックピン66,67が外方向へ押し出され、溝部28L,28Mと係合する(図11(a)⇒図11(b))。溝部28L,28Mと係合した後、制御プレート61と可動ホルダー30−1は、さらに移動し、ロックピン66,67に対して、制御プレート61の上面板61Tの溝61TL,61TMが位置移動する(図13(b)⇒図13(c))。 Immediately before the state shown in FIG. 13B, the lock pins 66 and 67 are pushed outward by the shape of the engaging protrusion 39 which is the convex portion of the movable holder 30, and engage with the grooves 28L and 28M. (FIG. 11 (a) → FIG. 11 (b)). After engaging with the grooves 28L and 28M, the control plate 61 and the movable holder 30-1 further move, and the grooves 61TL and 61TM of the upper surface plate 61T of the control plate 61 move relative to the lock pins 66 and 67. (FIG. 13 (b) → FIG. 13 (c)).
 操作者が手を離すと、まず、ロックピン66,67が溝部28L,28Mと係合している状態で、可動ホルダー30−1が移動する(図13(c)⇒図13(d))。所定の位置に到達すると、可動ホルダー30−1の凸部である、係合用突起39のホルダー側ガイド面39L,39Mの形状により、ロックピン66,67へ付与されていた外方向の押し出し力がなくなるので、ロックピン66,67と溝部28L,28Mと係合が解除される(図11(b))。 When the operator releases the hand, first, the movable holder 30-1 moves with the lock pins 66 and 67 engaged with the grooves 28L and 28M (FIG. 13 (c) → FIG. 13 (d)). . When the predetermined position is reached, the outward pushing force applied to the lock pins 66 and 67 due to the shape of the holder-side guide surfaces 39L and 39M of the engaging projection 39, which is the convex portion of the movable holder 30-1, is applied. As a result, the lock pins 66 and 67 and the grooves 28L and 28M are disengaged (FIG. 11B).
 そして、第2の弾性部材であるコイルばね64,65の復元力が作用し、制御プレート61と可動ホルダー30−1とが一緒に移動し(図11(b)⇒図11(a),図13(d)⇒13(e))、後退動作が完了する。このとき、係合が解除された、ロックピン66,67は、垂直面(支持側ガイド面)27L,27Mに沿ってスライドする。 Then, the restoring force of the coil springs 64 and 65, which are the second elastic members, acts, and the control plate 61 and the movable holder 30-1 move together (FIG. 11 (b) → FIG. 11 (a), FIG. 13 (d) ⇒13 (e)), the reverse operation is completed. At this time, the lock pins 66 and 67 that have been disengaged slide along the vertical surfaces (support side guide surfaces) 27L and 27M.
 また、本実施形態には、第1実施形態と異なり、支持機構20−1の側壁23−1に、ガイド棒51、連結棒53を固定するための側壁固定部23G,23Jは設けられていない。その代わりに、第2の弾性部材64,65が外側に嵌めこまれた位置調整ピン62,63が移動可能に挿入される、ピン挿入孔23P,23Qが開口されている。 Further, unlike the first embodiment, the present embodiment is not provided with side wall fixing portions 23G and 23J for fixing the guide rod 51 and the connecting rod 53 to the side wall 23-1 of the support mechanism 20-1. . Instead, the pin insertion holes 23P and 23Q into which the position adjusting pins 62 and 63 into which the second elastic members 64 and 65 are fitted to the outside are movably inserted are opened.
 制御プレート61の側面板61Sは、可動ホルダー30−1の一部が挿入されるように開口されている。本実施形態では、ガイド棒51−1の先端及び連結棒53−2の先端は、制御プレート61の側面板61Sに固定されている。側面板61Sには、ガイド棒51を固定する側面固定部61SGと、連動棒52を固定する側面固定部61SJとが設けられている(図12参照)。 The side plate 61S of the control plate 61 is opened so that a part of the movable holder 30-1 is inserted. In the present embodiment, the distal end of the guide rod 51-1 and the distal end of the connecting rod 53-2 are fixed to the side plate 61S of the control plate 61. The side plate 61S is provided with a side fixing portion 61SG that fixes the guide rod 51 and a side fixing portion 61SJ that fixes the interlocking rod 52 (see FIG. 12).
 また、制御プレート61の側面板61Sには、第2の弾性部材64,65が外側に嵌めこまれた位置調整ピン62,63が移動可能に挿入される、側面板ピン挿入孔61SP,61SQが開口されている。 The side plate 61S of the control plate 61 has side plate pin insertion holes 61SP and 61SQ into which the position adjusting pins 62 and 63 into which the second elastic members 64 and 65 are fitted are movably inserted. It is open.
 穿刺動作により、制御プレート61の側面板61Sが支持機構20−1の側壁23−1と接触する。一段階目の針管後退動作で、制御プレート61の側面板61Sが支持機構20−1の側壁23−1と接触した状態で、可動ホルダー30−1が後退する。二段階目の針管後退動作で、制御プレート61の側面板61Sが支持機構20−1の側壁23−1から離れていき、可動ホルダー30−1が後退する。 By the puncturing operation, the side plate 61S of the control plate 61 comes into contact with the side wall 23-1 of the support mechanism 20-1. In the first stage of the needle tube retraction operation, the movable holder 30-1 is retracted while the side plate 61S of the control plate 61 is in contact with the side wall 23-1 of the support mechanism 20-1. In the second-stage needle tube retraction operation, the side plate 61S of the control plate 61 moves away from the side wall 23-1 of the support mechanism 20-1, and the movable holder 30-1 retracts.
 [注射動作]
 図13は、第2実施形態に係る注射動作の動作説明図である。図15は、第2実施形態に係る注射動作フローの説明図である。下記、図13と図14とを用いて、第2実施形態における注射動作を説明する。
[Injection operation]
FIG. 13 is an operation explanatory diagram of an injection operation according to the second embodiment. FIG. 15 is an explanatory diagram of an injection operation flow according to the second embodiment. The injection operation in the second embodiment will be described below with reference to FIGS. 13 and 14.
 START:前提として、被検体に対して、注入用テンプレート100(図16参照)を用いて注入点、及び目印を印付けた後、注射器80(図3参照)を、注射装置2へセットし、注射装置2の当接ヘッド10−1を被検体に当接させる。 START: As a premise, the injection point and the mark are marked on the subject using the injection template 100 (see FIG. 16), and then the syringe 80 (see FIG. 3) is set in the injection device 2. The contact head 10-1 of the injection device 2 is brought into contact with the subject.
 <針管前進動作>
 図14のS11において、操作者が手動で、可動ホルダー30−1を当接ヘッド10に近づける(穿刺動作)。可動ホルダー30−1が当接ヘッド10−1への近接方向へ所定距離移動すると、第1の弾性部材54,55に対して、ガイド棒51−1及び連結棒53−2から、第1の弾性部材54,55に圧縮力が印加されるとともに、可動ホルダー30−1と一緒に、位置調整ピン62,63が当接ヘッド10−1への近接方向へ移動する。即ち、図13において、距離Dと距離Dが変らないまま距離Dが短くなり(ゼロになる)、第1の弾性部材54,55に圧縮力が印加される(図13(a)⇒(b))。
<Needle tube forward movement>
In S11 of FIG. 14, the operator manually brings the movable holder 30-1 closer to the contact head 10 (puncture operation). When the movable holder 30-1 moves a predetermined distance in the proximity direction to the contact head 10-1, the first elastic members 54, 55 are moved from the guide bar 51-1 and the connecting bar 53-2 to the first. A compressive force is applied to the elastic members 54 and 55, and the position adjusting pins 62 and 63 move in the proximity direction to the contact head 10-1 together with the movable holder 30-1. That is, in FIG. 13, the distance D P and the distance D L is not leave distance D M is shortened Henra (zero), the compressive force is applied to the first elastic member 54, 55 (FIG. 13 (a) (B)).
 所定の位置に達すると、ロックピン66,67が、支持機構20の溝部28L,28Mに係合する。 When the predetermined position is reached, the lock pins 66 and 67 engage with the grooves 28L and 28M of the support mechanism 20.
 その後、ロックピン66,67が支持機構20−1の溝部に嵌合した状態で、位置調整ピン62,63及び制御プレート61が当接ヘッド10−1の方向(前進方向)へ移動する。即ち、距離Dがゼロで変らないまま、距離Dも変わらないまま、距離Dが短くなり(ゼロになり)、第2の弾性部材64,65に圧縮力が印加される(図13(b)⇒(c))。 Thereafter, the position adjustment pins 62 and 63 and the control plate 61 move in the direction of the abutting head 10-1 (forward movement direction) in a state where the lock pins 66 and 67 are fitted in the grooves of the support mechanism 20-1. In other words, the distance D L is shortened (becomes zero) while the distance D M remains zero and the distance D P remains unchanged, and a compressive force is applied to the second elastic members 64 and 65 (FIG. 13). (B) ⇒ (c)).
 <針管後退動作>
 図14のS12として、操作者が可動ホルダー30−1から手を離す。可動ホルダー30−1が当接ヘッド10−1への近接方向の力が印加されなくなると、一段階目として、第1の弾性部材54,55の復元力により、位置調整ピン62,63及びロックピン66,67の位置は変わらず、可動ホルダー30−1が、支持機構20−1から離れる方向であって、押圧部40に近づける方向に移動することで、内容物を被検体へ注入するとともに、針管83を所望の深さから所定の位置まで後退させる。即ち、距離DIが変らないまま、距離Dが長くなり、距離Dが短くなる(D’)ことで、所定の距離の後退と、注入動作が行われる(図13(c)⇒(d))。
<Needle tube retraction>
As S12 in FIG. 14, the operator releases his hand from the movable holder 30-1. When the movable holder 30-1 no longer applies a force in the proximity direction to the contact head 10-1, as a first step, the position adjusting pins 62, 63 and the lock are restored by the restoring force of the first elastic members 54, 55. The positions of the pins 66 and 67 are not changed, and the movable holder 30-1 moves in the direction away from the support mechanism 20-1 and in the direction closer to the pressing unit 40, thereby injecting the contents into the subject. The needle tube 83 is retracted from a desired depth to a predetermined position. In other words, while the distance DI is not changed, the distance D M is increased, the distance D P becomes shorter (D P ') that is, the retraction of a predetermined distance, the injection operation is carried out (FIG. 13 (c) ⇒ ( d)).
 図14のS13の2段階目の後退動作として、ロックピン66,67が外れ(嵌合状態から解放され)、位置調整ピン62,63及び制御プレート61の位置が移動することで、第2の弾性部材64,65の復元力により、可動ホルダー30−1と、ガイド棒51と、接触する連結棒53と連動棒52とに嵌合された押圧部40が移動する。即ち、距離Dが変わらず、距離D’が変わらないまま、距離Dが長くなることで、注入動作が伴わずに、針管83を所定の位置から、被検体から抜針するまで後退させる(図13(d)⇒(e))。 As the second-stage backward movement operation of S13 in FIG. 14, the lock pins 66 and 67 are released (released from the fitted state), and the positions of the position adjustment pins 62 and 63 and the control plate 61 are moved. Due to the restoring force of the elastic members 64 and 65, the pressing portion 40 fitted to the movable holder 30-1, the guide bar 51, the connecting bar 53 and the interlocking bar 52 that are in contact with each other moves. That is, the distance D M is not changed, the distance D P ′ is not changed, and the distance D L is increased, so that the needle tube 83 is retracted from a predetermined position until the needle is removed from the subject without an injection operation. (FIG. 13 (d) ⇒ (e)).
 上記構成及びフローにより、本発明の注射装置2は注入動作が行われる際に、可動ホルダー30−1において注射筒84及び注射針81が適切に保持されている。特に、フランジ嵌合部31と針基ストッパー33により、内容物注入する際の移動方向の注射筒84及び注射針81の変位が規制されている。 With the above configuration and flow, when the injection operation of the injection device 2 of the present invention is performed, the syringe barrel 84 and the injection needle 81 are appropriately held in the movable holder 30-1. In particular, the flange fitting portion 31 and the needle base stopper 33 restrict displacement of the syringe barrel 84 and the injection needle 81 in the moving direction when the contents are injected.
 したがって、注射による注入する内容物として、粘性の高いゲル状構造の物質を用いた場合で、使用時に注射筒に高い圧力がかかったとしても、注射針81と注射筒84との連結状態は解消されない。よって、注射装置2により、精密な注射動作が実現できる。 Therefore, even when a highly viscous gel-like substance is used as the contents to be injected by injection, even if a high pressure is applied to the syringe cylinder during use, the connection state between the injection needle 81 and the syringe cylinder 84 is eliminated. Not. Therefore, a precise injection operation can be realized by the injection device 2.
 さらに、本実施形態では、二段階に後退するので、注入動作が終了した後に抜針する。したがって、被検体のごく浅い場所に、細胞等の微量で貴重な内容物を注入する場合に、注入した内容物が被検体の表面からあふれ出してしまうことなく注射動作が実施できる。 Furthermore, in this embodiment, the needle moves backward in two stages, so that the needle is removed after the injection operation is completed. Therefore, when a very small amount of valuable contents such as cells are injected into a very shallow place of the subject, the injection operation can be performed without overflowing the injected content from the surface of the subject.
 [適用手順]
 注入部位や注入方向を確定するため、注入前に注入部位の中心に注入用テンプレート100の中央の穴を合わせ(図15(b))、6つの縦長の穴に合わせて滅菌済み油性ペンにて印付けする(図15(c))。同一部位に期間を置いて繰り返し注入したい場合は、アートメーク用の染料などで注入部位に印をつける。頭皮などの有毛部に注入する場合は、注入部位の周辺を事前に刈毛しておく。注入前に注入部位周辺を消毒、乾燥させたのち、麻酔する。
[Apply procedure]
In order to determine the injection site and injection direction, the center hole of the injection template 100 is aligned with the center of the injection site before injection (FIG. 15 (b)), and aligned with the six vertically long holes with a sterilized oil pen A mark is made (FIG. 15C). If you want to inject repeatedly over the same site, mark the site with an art make dye. When injecting into hairy parts such as the scalp, the area around the injection site is clipped in advance. Before injection, the area around the injection site is disinfected and dried, and then anesthetized.
 注射器80を包装より取り出し、注射筒85内部に注入溶液を充填する。注射器80を注射装置1へセットするため、押圧部40の後端のボタン42hを押して当接ヘッド10とは反対側の最後端までスライドさせる(図16(a))。 The syringe 80 is taken out of the package, and the injection solution is filled into the syringe cylinder 85. In order to set the syringe 80 to the injection device 1, the button 42h at the rear end of the pressing portion 40 is pushed and slid to the rearmost end opposite to the contact head 10 (FIG. 16A).
 試験製剤の入った、注射針81、押し子88が連結された注射器80を、針先(針管の先端)を注射装置1の本体10,20などに接触させないように注意しながら、注射装置1の可動ホルダー30に装着する。詳しくは、図16(b)で示すように、注射器80を針先から斜めにはめ込み、注射筒84のフランジ(羽)86を立てて水平に押し込む(図16(c),(d))。そして、フランジ86を回転させて、フランジ嵌合部31に咬み合わせる(図16(e))。その後、注射装置1の押圧部40を押し子88の頭部88hに接触するまでゆっくりと移動させ、準備完了とする。(図16(f),図16(g))。 Injecting device 1 while taking care not to bring the needle tip (the tip of the needle tube) into contact with the main body 10, 20 of the injection device 1, etc. The movable holder 30 is attached. Specifically, as shown in FIG. 16B, the syringe 80 is inserted obliquely from the needle tip, and the flange (wing) 86 of the syringe barrel 84 is raised and pushed horizontally (FIGS. 16C and 16D). Then, the flange 86 is rotated to engage with the flange fitting portion 31 (FIG. 16 (e)). Thereafter, the pressing portion 40 of the injection device 1 is slowly moved until it comes into contact with the head 88h of the pusher 88 to complete the preparation. (FIG. 16 (f), FIG. 16 (g)).
 注射器80が装着された注射装置1(図17(a))を用いて、当接ヘッド10の位置決め溝と滅菌済み油性ペンで付けた印を合わせる。この状態で、当接ヘッド10を頭皮にしっかりと押し当てる(図17(b),図8のSTART)。 Using the injection device 1 (FIG. 17 (a)) to which the syringe 80 is attached, the positioning groove of the contact head 10 and the mark attached with a sterilized oil pen are aligned. In this state, the contact head 10 is firmly pressed against the scalp (FIG. 17B, START in FIG. 8).
 この状態で、可動ホルダー30を手動で当接ヘッド10側へ押し込んで、可動ホルダー30と一緒に動く注射針81の針管83を頭皮内に穿刺する(図8のS1に相当)。この際、上方から、当接ヘッド10の中央部の長穴状の開口部11を視認することで、針管83が頭皮に穿刺されていることを確認する。 In this state, the movable holder 30 is manually pushed into the contact head 10 side, and the needle tube 83 of the injection needle 81 that moves together with the movable holder 30 is punctured into the scalp (corresponding to S1 in FIG. 8). At this time, it is confirmed from above that the needle tube 83 is punctured into the scalp by visually recognizing the elongated hole-like opening 11 at the center of the contact head 10.
 そして、注射装置1の可動ホルダー30からゆっくりと手を離すことにより製剤が頭皮内に注入される(図8のS2に相当)。そして、注入動作完了後、注射装置1を頭皮から離す(図8のENDに相当)。 Then, the preparation is injected into the scalp by slowly releasing the hand from the movable holder 30 of the injection device 1 (corresponding to S2 in FIG. 8). Then, after the injection operation is completed, the injection device 1 is separated from the scalp (corresponding to END in FIG. 8).
 同一の注入部位から、異なる方向に複数回注入する場合は、皮膚上の油性ペンの印と当接ヘッド10周囲に設けられた溝15を別の方向に合わせ、上記の注入操作を繰り返す。これを注入用の印のある6ヵ所において繰り返すことにより、1mLの注射筒を使用した場合は計1.0mLの試験製剤が注入される。 When injecting a plurality of times in different directions from the same injection site, the oil pen on the skin and the groove 15 provided around the contact head 10 are aligned in different directions and the above injection operation is repeated. By repeating this at 6 locations with the injection marks, a total of 1.0 mL of the test preparation is injected when a 1 mL syringe is used.
 使用後の注射装置は、注射筒84と注射針81とを取り外し、廃棄した上で、洗浄及びメンテナンスを行い、個別の滅菌バッグに梱包して滅菌にかける。滅菌は、オートクレーブ、EOガス、ガンマ線滅菌等のいずれでも可能である。 After use, the injection device 84 is removed from the syringe 84 and the needle 81, discarded, cleaned and maintained, and packed in a separate sterilization bag for sterilization. Sterilization can be any of autoclave, EO gas, gamma ray sterilization, and the like.
 ここで、上述の構成により、注射動作を行う期間中、注射装置1、2では、注射筒84と注射針81は連結状態が維持されるので、内容物は、ほとんど注射装置1,2の内部には漏れ出さないと考えられる。従って、洗浄や滅菌工程は、当接ヘッド10の下面12を重点的に行えば十分であり、注射筒の脱着が予想される従来例の注射装置と比較して、注射器が取り付けられる、注射装置の内部の汚染はほとんど考慮しなくてもよい。 Here, with the above-described configuration, since the syringe 84 and the injection needle 81 are kept connected in the injection devices 1 and 2 during the period of performing the injection operation, the contents are mostly inside the injection devices 1 and 2. It is thought that it will not leak. Accordingly, it is sufficient for the cleaning and sterilization process to be performed with a focus on the lower surface 12 of the contact head 10, and the injection device to which the syringe is attached as compared with the conventional injection device in which the syringe barrel is expected to be attached and detached. There is little need to consider the contamination inside.
 上述の本発明の実施形態に係る注射装置で用いる、内容物(物質)は、細胞懸濁液、ゲル状材料、治療的物質、美容的物質、及び診断的物質で構成される群から選択されうる。例えば、上記注射装置で用いられる内容物(物質)は、細胞懸濁液、ゲル状材料、治療的物質、美容的物質、及び診断的物質で構成される群から選択されうる。 The content (substance) used in the injection device according to the above-described embodiment of the present invention is selected from the group consisting of a cell suspension, a gel material, a therapeutic substance, a cosmetic substance, and a diagnostic substance. sell. For example, the content (substance) used in the injection device can be selected from the group consisting of cell suspensions, gel-like materials, therapeutic substances, cosmetic substances, and diagnostic substances.
 注入される美容的物質として、フィラー(filler)のような脂肪細胞、ヒアルロン酸、又は皺治療におけるボツリヌス毒素(Botox、Btx)等を含み得るが、これらに限定されない。治療的物質は、抗生物質、麻酔薬、鎮痛薬、ワクチン、抗体を含み得るが、これらに限定されない。 The cosmetic substance to be injected may include, but is not limited to, fat cells such as filler, hyaluronic acid, or botulinum toxin (Botox, Btx) in acupuncture. The therapeutic agent may include, but is not limited to, antibiotics, anesthetics, analgesics, vaccines, antibodies.
 さらに、注射器内に収容される内容物として、懸濁液内の細胞又は液体媒体内の細胞を被験者に注入するために、本発明の注射装置が用いてもよい。 Furthermore, the injection device of the present invention may be used for injecting cells in a suspension or cells in a liquid medium into a subject as contents contained in a syringe.
 さらに、注射器内に収容される内容物として、細胞懸濁液が発育因子と混合されてもよい。または、細胞懸濁液がゲル状構造を含んでいてもよい。そのようなゲル状構造は、別個の組織の細胞外環境を真似る細胞外基質タンパク質の混合を表すのが好ましく、更に好ましくは、ヒアルロン酸のようなゲル状構造である。 Furthermore, a cell suspension may be mixed with a growth factor as the contents contained in the syringe. Alternatively, the cell suspension may contain a gel structure. Such a gel-like structure preferably represents a mixture of extracellular matrix proteins that mimic the extracellular environment of separate tissues, more preferably a gel-like structure such as hyaluronic acid.
 さらに、被験者の別個の組織内への物質を注入するために本発明の実施形態に係る注射装置を用いられてもよい。特に、抜け毛、円形脱毛症のような脱毛症、又は毛の欠如若しくは少な過ぎる毛に関連する他の症状の治療における、細胞懸濁液としての、皮膚内への細胞の注入に注射装置を用いられ得る。 Furthermore, the injection device according to the embodiment of the present invention may be used to inject a substance into a separate tissue of a subject. In particular, the injection device is used to inject cells into the skin as a cell suspension in the treatment of hair loss, alopecia such as alopecia areata, or other conditions associated with hair loss or too little hair Can be.
 また、本発明の注射装置は、薬剤、サイトカイン、又は発育因子のような、液体を被験者に注入するために用いられるのが好ましい。被験者への液体のこの適用は、抜け毛、円形脱毛症のような脱毛症、又は毛の欠如若しくは少な過ぎる毛に関連する他の症状の治療に関連して行われるのが好ましい。 Also, the injection device of the present invention is preferably used for injecting a liquid such as a drug, cytokine, or growth factor into a subject. This application of the liquid to the subject is preferably done in connection with the treatment of hair loss, alopecia such as alopecia areata, or other conditions associated with hair loss or too little hair.
 あるいは、本発明の実施態様に係る注射装置を、被験者の筋肉への物質の注入、又は被験者の腱への物質を注入するために用いてもよい。 Alternatively, the injection device according to the embodiment of the present invention may be used for injecting a substance into the subject's muscle or injecting a substance into the subject's tendon.
 さらに、本発明の実施態様に係る注射装置を適用する被検体として、人間(被検者)に限定されず、魚、ネズミなどの動物であってもよい。または、被検体は、被験者や被験対象動物から取り出した皮膚、臓器等の、組織であってもよい。 Furthermore, the subject to which the injection device according to the embodiment of the present invention is applied is not limited to a human (subject), and may be an animal such as a fish or a mouse. Alternatively, the subject may be a tissue such as a skin or an organ taken out from the subject or the test subject animal.
 以上、本発明の好ましい実施形態について詳述したが、本発明は上記した特定の実施形態に限定されるものではなく、特許請求の範囲に記載された本発明の要旨の範囲内において、種々の変形・変更が可能なものである。 The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific embodiments described above, and various modifications are possible within the scope of the gist of the present invention described in the claims. It can be modified and changed.
 本国際出願は2016年4月20日に出願された日本国特許出願2016−084281号に基づく優先権を主張するものであり、その全内容をここに援用する。 This international application claims priority based on Japanese Patent Application No. 2006-084281 filed on April 20, 2016, the entire contents of which are incorporated herein by reference.
1,2 注射装置
10,10−1 当接ヘッド
11 開口部
12 下面
12c 下面中央部
14 側面
15 印位置決め溝
16 つば部
20,20−1 支持機構
21 ホルダーガイド経路(挿入穴)
22 移動案内レール
23 支持機構の側壁
23O 開口部
24 支持機構の上面カバー
25 支持機構の下面切り込み開口部
30,30−1 可動ホルダー
31 フランジ嵌合部
32 外筒部挟持部
33 針基ストッパー
34 周面保持部
35 平面部
36,37 突起(バネ保持部材)
36S,37S 突起側面
38 接着部材
310 前方ホルダー
320 後方ホルダー
330 移動支持部
331 第1の貫通孔
40 押圧部(注入制御機構)
41 歯止め(板バネ)
42 板バネ支持棒
42h ボタン
43 押圧部バネ
44 カバー
51,51−1 ガイド棒
51r 係合ラック
52 連動棒
52r 係合ラック
53,53−1 連結棒
53T 連結棒の大径の終端
54,55 コイルばね(第1の弾性部材)
80 注射器
81 注射針
82 針基
83 針管
84 注射筒(シリンジ)
85 外筒部
86 フランジ
87 筒先
88 押し子(プランジャー)
88h 押し子頭部
89 ガスケット
60 制御機構
61 制御プレート
61S 制御プレートの側面板
61SG,61SJ 側面板固定部
61SP,61SQ 側面板ピン挿入孔
61T 制御プレートの上面板
62,63 移動調整ピン
64,65 コイルばね(第2の弾性部材)
66,67 ロックピン
23P,23Q ピン挿入孔
24−1 支持機構の上面部
26 切欠け部
27L,27M 垂直面(支持側ガイド面)
28L,28M 溝部
39 係合用突起
39L,39M 垂直面(ホルダー側ガイド面)
100 注入用テンプレート
DESCRIPTION OF SYMBOLS 1, 2, Injection device 10, 10-1 Contact head 11 Opening part 12 Lower surface 12c Lower surface center part 14 Side surface 15 Marking groove | channel 16 Collar part 20, 20-1 Support mechanism 21 Holder guide path | route (insertion hole)
22 Movement guide rail 23 Side wall 23O of support mechanism Opening 24 Upper surface cover 25 of support mechanism Lower surface notch opening 30 and 30-1 of support mechanism Movable holder 31 Flange fitting part 32 Outer cylinder part clamping part 33 Needle base stopper 34 circumference Surface holding portion 35 Flat portion 36, 37 Projection (spring holding member)
36S, 37S Projection side surface 38 Adhesive member 310 Front holder 320 Rear holder 330 Movement support portion 331 First through hole 40 Pressing portion (injection control mechanism)
41 Pawl (leaf spring)
42 Leaf spring support bar 42h Button 43 Pressing part spring 44 Cover 51, 51-1 Guide bar 51r Engagement rack 52 Interlocking bar 52r Engagement rack 53, 53-1 Connection rod 53T Large diameter end 54, 55 coil of connection rod Spring (first elastic member)
80 Syringe 81 Injection needle 82 Needle base 83 Needle tube 84 Syringe (syringe)
85 Outer tube portion 86 Flange 87 Tube tip 88 Pusher (plunger)
88h Pusher head 89 Gasket 60 Control mechanism 61 Control plate 61S Control plate side plate 61SG, 61SJ Side plate fixing part 61SP, 61SQ Side plate pin insertion hole 61T Control plate top plate 62, 63 Movement adjustment pins 64, 65 Coil Spring (second elastic member)
66, 67 Lock pin 23P, 23Q Pin insertion hole 24-1 Upper surface portion 26 of support mechanism Notch portion 27L, 27M Vertical surface (support side guide surface)
28L, 28M Groove 39 Engaging projection 39L, 39M Vertical surface (holder-side guide surface)
100 template for injection

Claims (23)

  1.  押し子、該押し子が挿嵌される注射筒、及び該注射筒に連結される針基と被検体内へ穿刺される針管からなる注射針を備える注射器によって、被検体に内容物を注入させる注射装置であって、
     被検体と当接可能であり、前記針管が通る開口部が形成された当接ヘッドと、
     前記注射筒及び前記注射針を保持する可動ホルダーと、
     前記当接ヘッドに固定される支持機構と、
     前記押し子を前記注射筒の内部へ押し込む内容物注入制御機構と、を備えており、
     前記可動ホルダーが前記支持機構に沿って移動することで、前記注射筒及び前記注射針を、前記当接ヘッドに対して移動させ、
     前記注射器は、当該注射装置に対して着脱可能であることを特徴とする
     注射装置。
    The subject is injected with contents by a syringe having a pusher, a syringe barrel into which the pusher is inserted, and a needle base connected to the syringe barrel and a needle tube punctured into the subject. An injection device,
    An abutting head capable of abutting against a subject and having an opening through which the needle tube passes;
    A movable holder for holding the syringe barrel and the injection needle;
    A support mechanism fixed to the contact head;
    A content injection control mechanism for pushing the pusher into the syringe barrel, and
    By moving the movable holder along the support mechanism, the syringe barrel and the injection needle are moved with respect to the contact head,
    The injection device is detachable from the injection device.
  2.  前記内容物注入制御機構は、前記注射筒内に対して前記押し子を押し込む押圧部を備え、
     前記可動ホルダーが前記当接ヘッドへ近づく前進方向へ移動することで、前記針管を被検体に穿刺し、被検体の内部へと進入させ、
     前記可動ホルダーが前記当接ヘッドから離れる後退方向へ移動することで、前記針管を被検体に対して後退させながら、前記可動ホルダーが前記押圧部に近づき、前記注射筒内に対して前記押し子を押し込んで、前記内容物を被検体に注入することを特徴とする
     請求項1に記載の注射装置。
    The content injection control mechanism includes a pressing portion that pushes the pusher into the syringe barrel,
    By moving the movable holder in the forward direction approaching the contact head, the needle tube is punctured into the subject and entered into the subject,
    By moving the movable holder in the retracting direction away from the contact head, the movable holder approaches the pressing portion while retracting the needle tube with respect to the subject, and the pusher is moved into the syringe barrel. The injection device according to claim 1, wherein the content is injected into the subject by pushing in the.
  3.  前記注射筒は、前記内容物を収容する外筒部と、前記外筒部の後端に設けられるフランジとを備え、
     前記可動ホルダーは、前記フランジと嵌合することで保持するフランジ嵌合部を備え、前記フランジ嵌合部は、前記可動ホルダーに対する、前記フランジの前記後退方向への移動を規制することを特徴とする
     請求項2に記載の注射装置。
    The syringe barrel includes an outer cylinder portion that contains the contents, and a flange provided at a rear end of the outer cylinder portion,
    The movable holder includes a flange fitting portion that is held by fitting with the flange, and the flange fitting portion regulates movement of the flange in the backward direction with respect to the movable holder. The injection device according to claim 2.
  4.  前記可動ホルダーは、前記外筒部の側部の両側に沿って起立する突起により、前記外筒部を挟み込んで保持する外筒部挟持部を備え、前記外筒部挟持部は、前記可動ホルダーに対する、前記外筒部の横方向の変位を規制することを特徴とする
     請求項3に記載の注射装置。
    The movable holder includes an outer cylindrical portion clamping portion that sandwiches and holds the outer cylindrical portion by protrusions that stand along both sides of the side portion of the outer cylindrical portion, and the outer cylindrical portion clamping portion includes the movable holder. The injection device according to claim 3, wherein a lateral displacement of the outer cylinder portion with respect to the inner side is restricted.
  5.  前記可動ホルダーは、前記針基の先端付近と当接する突起により、前記注射針の移動を停止させて保持する針基ストッパーを備え、前記針基ストッパーは、前記可動ホルダーに対する、前記針基の前記前進方向への移動を規制する、ことを特徴とする
     請求項2に記載の注射装置。
    The movable holder is provided with a needle base stopper that stops and holds the movement of the injection needle by a protrusion that contacts the vicinity of the tip end of the needle base, and the needle base stopper is located on the needle base with respect to the movable holder. The injection device according to claim 2, wherein movement in a forward direction is restricted.
  6.  前記可動ホルダーは、前記針基を、周面状に保持する周面保持部を備え、前記周面保持部は、前記可動ホルダーに対する、前記針基の横方向の変位を規制することを特徴とする
     請求項2に記載の注射装置。
    The movable holder includes a peripheral surface holding portion that holds the needle base in a circumferential shape, and the peripheral surface holding portion regulates a lateral displacement of the needle base with respect to the movable holder. The injection device according to claim 2.
  7.  前記内容物注入制御機構は、
     前記可動ホルダー及び前記押圧部に対して、移動可能に係合されるガイド棒と、
     前記可動ホルダーに締結され、前記押圧部に対し移動可能に係合される連動棒と、
     前記連動棒と同一直線状に延伸し、後端が前記連動棒の先端と対向して、接触・離間可能であり、前記後端が前記可動ホルダーの内部に位置する連結棒と、を備えることを特徴とする
     請求項2に記載の注射装置。
    The content injection control mechanism is:
    A guide bar movably engaged with the movable holder and the pressing portion;
    An interlocking rod fastened to the movable holder and movably engaged with the pressing portion;
    A connecting rod that extends in the same straight line as the interlocking rod, has a rear end facing the tip of the interlocking rod, can be contacted / separated, and the rear end is located inside the movable holder. The injection device according to claim 2.
  8.  前記連動棒及び前記ガイド棒は、前記押圧部と対向可能な部分の周面には、傾きを持った係合ラックを有し、
     前記押圧部は、前記連動棒及び前記ガイド棒の係合ラックと噛み合う歯止めを備えており、
     前記押圧部は、前記可動ホルダーに近づいて、前記押し子を前記注射筒の内部へ押し込む方向に、前記連動棒及び前記ガイド棒に対して、相対移動可能であり、前記可動ホルダーから遠ざかる方向へは移動がロックされる、ラチェット機構を構成することを特徴とする
     請求項7に記載の注射装置。
    The interlocking rod and the guide rod have an engaging rack having an inclination on a peripheral surface of a portion that can face the pressing portion,
    The pressing portion includes a pawl that meshes with an engagement rack of the interlocking rod and the guide rod,
    The pressing portion approaches the movable holder and is movable relative to the interlocking rod and the guide rod in a direction to push the pusher into the syringe barrel, and away from the movable holder. The injection device according to claim 7, comprising a ratchet mechanism whose movement is locked.
  9.  前記可動ホルダーに第1の弾性部材が設けられており、
     前記可動ホルダーは、前記注射筒を保持する部分の下部に、前記ガイド棒がスライド可能に挿通する第1の貫通孔と、先端に前記連結棒がスライド可能に挿入され、同一直線上の後端に前記連動棒が締結される第2の貫通孔とが形成された移動支持部を備え、
     前記可動ホルダーが前記当接ヘッドへ近づく前記前進方向へ移動すると、前記第1の弾性部材に対して、前記ガイド棒及び前記連結棒から、前記第1の弾性部材に圧縮力が印加され、
     前記第1の弾性部材の復元力により、前記可動ホルダーが、前記支持機構から離れる方向へ移動させることを特徴とする
     請求項7に記載の注射装置。
    A first elastic member is provided on the movable holder;
    The movable holder has a first through hole through which the guide rod is slidably inserted at a lower portion of a portion holding the syringe barrel, and a slidable insertion at the tip of the connecting rod, and a rear end on the same straight line. A moving support portion formed with a second through hole to which the interlocking rod is fastened,
    When the movable holder moves in the forward direction approaching the contact head, a compressive force is applied to the first elastic member from the guide rod and the connecting rod to the first elastic member,
    The injection apparatus according to claim 7, wherein the movable holder is moved in a direction away from the support mechanism by a restoring force of the first elastic member.
  10.  前記第1の貫通孔と前記第2の貫通孔の内壁には、前記内壁から突出するバネ保持部材が設けられ、
     前記ガイド棒及び前記連結棒は、夫々小径部と大径部が設けられて、該小径部は前記ガイド棒及び前記連結棒の伸長方向において、前記可動ホルダーの中央付近に位置し、大径部は、前記可動ホルダーの先端側に位置し、
     前記第1の弾性部材の、先端は前記ガイド棒及び前記連結棒の大径部から小径部へ縮径する側面に保持され、後端は前記バネ保持部材に保持されることを特徴とする
     請求項9に記載の注射装置。
    A spring holding member protruding from the inner wall is provided on the inner walls of the first through hole and the second through hole,
    The guide rod and the connecting rod are each provided with a small diameter portion and a large diameter portion, and the small diameter portion is located near the center of the movable holder in the extending direction of the guide rod and the connecting rod. Is located on the tip side of the movable holder,
    The front end of the first elastic member is held on a side surface of the guide rod and the connecting rod that is reduced in diameter from a large diameter portion to a small diameter portion, and a rear end is held on the spring holding member. Item 10. The injection device according to Item 9.
  11.  前記支持機構の後端側の側壁は、前記可動ホルダーの一部が挿入されるように開口され、前記ガイド棒の先端及び前記連結棒の先端が固定されており、
     前記可動ホルダーが前記当接ヘッドへ近づく前進方向へ移動するとき、前記支持機構の側壁が、前記可動ホルダーの一部と当接することで、前記可動ホルダーの前記当接ヘッドへの前記前進方向へ移動を停止させ、
     前記第1の弾性部材の復元力により、前記可動ホルダーが前記当接ヘッドから離れる後退方向へ移動するとき、前記内容物を被検体に注入すると同時に、前記針管を所望の深さから被検体表面まで後退させて抜針させることを特徴とする
     請求項10に記載の注射装置。
    The side wall on the rear end side of the support mechanism is opened so that a part of the movable holder is inserted, and the tip of the guide rod and the tip of the connecting rod are fixed,
    When the movable holder moves in the forward direction approaching the contact head, the side wall of the support mechanism comes into contact with a part of the movable holder, so that the movable holder moves in the forward direction toward the contact head. Stop moving,
    When the movable holder moves in a retracting direction away from the contact head by the restoring force of the first elastic member, the contents are injected into the subject and the needle tube is moved from the desired depth to the subject surface. The injection device according to claim 10, wherein the needle is retracted until the needle is removed.
  12.  前記支持機構は、上方及び側方において少なくとも前記注射針及び前記可動ホルダーの前記注射針を保持する部分を、周面方向で覆うカバーを備え、前記可動ホルダーが前記支持機構の内部に挿入されることを特徴とする
     請求項11に記載の注射装置。
    The support mechanism includes a cover that covers at least the injection needle and a portion of the movable holder that holds the injection needle in the upper and side directions in a circumferential direction, and the movable holder is inserted into the support mechanism. The injection device according to claim 11.
  13.  当該注射装置は、さらに抜針制御機構を備え、
     前記内容物注入制御機構は、前記針管を被検体に対して所望の位置まで後退させながら、前記可動ホルダーが前記押圧部に近づき、前記注射筒内に対して前記押し子を押し込んで、前記内容物を被検体に注入する、一段階目の針管後退動作を制御し、
     前記抜針制御機構は、前記内容物を前記被検体へ注入せずに、前記針管を所定の位置から、少なくとも前記被検体の表面まで後退させ、抜針させる二段階目の針管後退動作を制御することを特徴とする
     請求項2に記載の注射装置。
    The injection device further includes a needle removal control mechanism,
    The contents injection control mechanism moves the needle tube toward the desired position with respect to the subject while the movable holder approaches the pressing portion and pushes the pusher into the syringe barrel. Control the first stage of needle tube retraction, which injects objects into the subject,
    The needle removal control mechanism controls a second-stage needle tube retraction operation in which the needle tube is retracted from a predetermined position to at least the surface of the subject and the needle is withdrawn without injecting the contents into the subject. The injection device according to claim 2.
  14.  前記抜針制御機構は、
     前記支持機構の少なくとも一部の上面を覆う上面板と、前記当接ヘッドとは離れた後端側の側壁を覆う側面板とを備える制御プレートを備え、
     大径の頭部を備え、前記制御プレートの前記側面板に挿入される2本の位置調整ピンと、
     前記位置調整ピンの外側に嵌めこまれ、前記制御プレートの側面板と、前記支持機構とに接して設けられる、第2の弾性部材と、
     前記支持機構の上面に設けられ、一端が前記可動ホルダーの周面保持部の一部の側面に保持され、前記注射筒とは、略垂直の方向に伸長するように設けられる2つの弾性ピンとを備えており、
     前記支持機構は、上面及び側面を備え、前記可動ホルダーの移動を案内するガイド経路が形成されている、
     前記支持機構の前記上面に、前記弾性ピンが嵌合される2つの溝部が形成され、
     前記支持機構の前記側面に、前記第2の弾性部材が外側に嵌めこまれた前記位置調整ピンが挿入される前記ガイド経路の入り口である挿入穴が形成されることを特徴とする
     請求項13に記載の注射装置。
    The needle removal control mechanism is
    A control plate comprising an upper surface plate covering at least a part of the upper surface of the support mechanism and a side plate covering a side wall on the rear end side separated from the contact head;
    Two position adjustment pins, each having a large-diameter head and inserted into the side plate of the control plate;
    A second elastic member that is fitted on the outside of the position adjustment pin and is provided in contact with the side plate of the control plate and the support mechanism;
    Two elastic pins provided on the upper surface of the support mechanism, one end of which is held on a part of a side surface of the peripheral surface holding portion of the movable holder, and provided so as to extend in a substantially vertical direction. Has
    The support mechanism includes an upper surface and a side surface, and a guide path for guiding the movement of the movable holder is formed.
    Two grooves are formed on the upper surface of the support mechanism to which the elastic pins are fitted,
    14. An insertion hole serving as an entrance of the guide path into which the position adjustment pin with the second elastic member fitted outside is inserted is formed in the side surface of the support mechanism. The injection device described in 1.
  15.  前記内容物注入制御機構は、
     前記可動ホルダー及び前記押圧部に対して、移動可能に係合されるガイド棒と、
     前記可動ホルダーに締結され、前記押圧部に対し移動可能に係合される連動棒と、
     前記連動棒と同一直線状に延伸し、後端が前記連動棒の先端と対向して、接触・離間可能であり、前記後端が前記可動ホルダーの内部に位置する連結棒と、を備え、
     前記支持機構の後端側の側壁は、前記可動ホルダーの一部が挿入されるように開口され、
     前記制御プレートの前記側面板は、前記可動ホルダーの一部が挿入されるように開口され、前記ガイド棒の先端及び前記連結棒の先端が固定されており、
     前記可動ホルダーが前記当接ヘッドへ近づく前進方向へ移動するとき、前記制御プレートの前記側面板が、前記可動ホルダーの一部と当接した後、前記制御プレートの前記側面板が前記支持機構の前記側面と接触することで、前記可動ホルダーの前記当接ヘッドへの前記前進方向へ移動を停止させ、
     前記一段階目の針管後退動作では、前記制御プレートの前記側面板が前記支持機構の前記側面と接触した状態で、前記可動ホルダーが前記押圧部に近づきながら前記可動ホルダーが後退方向へ移動し
     前記二段階目の針管後退動作では、前記制御プレートの前記側面板が前記支持機構の前記側面から離れていき、前記可動ホルダーが前記押圧部との所定の距離を保ったまま、前記可動ホルダーが後退方向へ移動することを特徴とする
     請求項14に記載の注射装置。
    The content injection control mechanism is:
    A guide bar movably engaged with the movable holder and the pressing portion;
    An interlocking rod fastened to the movable holder and movably engaged with the pressing portion;
    Extending in the same straight line as the interlocking rod, the rear end is opposed to the tip of the interlocking rod and can be contacted and separated, and the rear end is provided with a connecting rod located inside the movable holder,
    The side wall on the rear end side of the support mechanism is opened so that a part of the movable holder is inserted,
    The side plate of the control plate is opened so that a part of the movable holder is inserted, and the tip of the guide rod and the tip of the connecting rod are fixed,
    When the movable holder moves in the forward direction approaching the contact head, the side plate of the control plate comes into contact with a part of the movable holder, and then the side plate of the control plate By making contact with the side surface, the movement of the movable holder to the contact head in the forward direction is stopped,
    In the first-stage needle tube retraction operation, the movable holder moves in the retraction direction while the movable holder approaches the pressing portion in a state where the side plate of the control plate is in contact with the side surface of the support mechanism. In the second-stage needle tube retraction operation, the side plate of the control plate moves away from the side surface of the support mechanism, and the movable holder moves backward while the movable holder maintains a predetermined distance from the pressing portion. The injection device according to claim 14, wherein the injection device moves in a direction.
  16.  前記抜針制御機構において、
     前記可動ホルダーに第1の弾性部材が設けられており、
     前記可動ホルダーが前記当接ヘッドへの近接方向へ所定距離移動すると、前記第1の弾性部材に対して、前記ガイド棒及び前記連結棒から、前記可動ホルダーの内部に設けられた前記第1の弾性部材に圧縮力が印加された後、
     前記可動ホルダーと一緒に前記弾性ピンが前記当接ヘッドへの近接方向へ移動し、所定の位置に達すると、前記弾性ピンが溝部に係合した後、
     前記弾性ピンが前記支持機構の前記溝部に嵌合した状態で、前記位置調整ピン及び前記制御プレートが前記当接ヘッドの方向へ移動し、前記第2の弾性部材に圧縮力が印加されることを特徴とする
     請求項15に記載の注射装置。
    In the needle removal control mechanism,
    A first elastic member is provided on the movable holder;
    When the movable holder moves a predetermined distance in the proximity direction to the contact head, the first elastic member is provided with the first elastic member provided in the movable holder from the guide rod and the connecting rod. After compressive force is applied to the elastic member,
    When the elastic pin moves in the proximity direction to the contact head together with the movable holder and reaches a predetermined position, the elastic pin is engaged with the groove,
    In a state where the elastic pin is fitted in the groove of the support mechanism, the position adjusting pin and the control plate move toward the contact head, and a compressive force is applied to the second elastic member. The injection device according to claim 15.
  17.  前記可動ホルダーが前記当接ヘッドへの近接方向の力が印加されなくなると、
     一段階目として、前記第1の弾性部材の復元力により、前記位置調整ピン及び弾性ピンの位置は変わらず、前記可動ホルダーが、前記支持機構から離れる方向であって、前記押圧部に近づける方向に移動することで、前記内容物を前記被検体へ注入するとともに、前記針管を所望の深さから所定の位置まで後退させ、
     2段階目として、前記弾性ピンがはずれ、前記位置調整ピン及び前記制御プレートの位置が移動することで、前記第2の弾性部材の復元力により、前記可動ホルダーと、前記ガイド棒に嵌合された前記押圧部が移動することで、前記針管を所望の深さから所定の位置まで後退させることを特徴とする
     請求項16に記載の注射装置。
    When the movable holder is no longer applied with a force in the proximity direction to the contact head,
    As a first step, the position of the position adjusting pin and the elastic pin does not change due to the restoring force of the first elastic member, and the movable holder is away from the support mechanism and close to the pressing portion. And injecting the contents into the subject, retracting the needle tube from a desired depth to a predetermined position,
    As a second step, the elastic pin is disengaged, and the position adjusting pin and the control plate are moved so that the movable holder and the guide rod are fitted by the restoring force of the second elastic member. The injection device according to claim 16, wherein the needle tube is retracted from a desired depth to a predetermined position by the movement of the pressing portion.
  18.  前記当接ヘッドの下面において、前記開口部の周辺の表面が他の下面に対して内側に位置するように構成され、前記被検体に前記内容物を注入する際、前記下面は前記被検体と部分的に当接し、前記開口部の前記周辺は前記被検体と非接触となることを特徴とする
     請求項1に記載の注射装置。
    The lower surface of the contact head is configured such that the surface around the opening is positioned inside the other lower surface, and when the content is injected into the subject, the lower surface is in contact with the subject. The injection device according to claim 1, wherein the injection device is in partial contact, and the periphery of the opening is not in contact with the subject.
  19.  前記当接ヘッドの前記下面の縁部に連続的又は断続的に、前記下面の表面方向に突出する突起が形成されており、前記開口部の周囲を取り囲むように、前記突起の上面が前記被検体と当接することを特徴とする
     請求項18に記載の注射装置。
    A protrusion protruding in the surface direction of the lower surface is formed continuously or intermittently on the edge of the lower surface of the contact head, and the upper surface of the protrusion is surrounded by the cover so as to surround the opening. The injection device according to claim 18, wherein the injection device is in contact with a specimen.
  20.  穿刺動作の開始前及び抜針動作の終了後、前記針管の先端が、前記当接ヘッドの前記下面の前記被検体と当接する部分よりも上方に位置することを特徴とする
     請求項18に記載の注射装置。
    The tip of the needle tube is positioned above a portion of the lower surface of the contact head that comes into contact with the subject before the start of the puncture operation and after the end of the needle extraction operation. Injection device.
  21.  前記当接ヘッドの前記開口部は、前記当接ヘッドの下面に対して、前記可動ホルダーの移動に伴い前記針管が通る方向及び前記当接ヘッドの上下方向の二股方向に貫通しており、
     前記当接ヘッドの上面における前記開口部が、注入点に対応する位置から前記支持機構に向かって細長く伸びて開口する長穴形状であることを特徴とする
     請求項1に注射装置。
    The opening of the contact head penetrates the lower surface of the contact head in a bifurcated direction in the direction in which the needle tube passes and the vertical direction of the contact head as the movable holder moves.
    The injection device according to claim 1, wherein the opening on the upper surface of the contact head has an elongated hole shape that is elongated from the position corresponding to the injection point toward the support mechanism.
  22.  前記支持機構には、前記可動ホルダーの少なくとも一部を、スライド可能に支持する周面形状の移動案内レールが備えられていることを特徴とする
     請求項1に記載の注射装置。
    The injection device according to claim 1, wherein the support mechanism is provided with a movement guide rail having a circumferential shape that slidably supports at least a part of the movable holder.
  23.  前記注射器の脱着のとき前記針管が接触しないように、前記支持機構の前記移動案内レールの下部が開放され、
     前記当接ヘッドの下面において、前記開口部として、前記可動ホルダーの移動に伴い前記針管が通る方向において、上下方向に貫通する部分から前記支持機構に向かって前記当接ヘッドの前記下面の縁部に達する切り込み形状が設けられていることを特徴とする
     請求項22に記載の注射装置。
    The lower part of the moving guide rail of the support mechanism is opened so that the needle tube does not contact when the syringe is detached.
    On the lower surface of the contact head, as the opening, an edge of the lower surface of the contact head from a portion penetrating in the vertical direction in the direction in which the needle tube passes along with the movement of the movable holder toward the support mechanism The injection device according to claim 22, wherein a cut shape is provided so as to reach.
PCT/IB2017/000651 2016-04-20 2017-05-30 Injection device WO2017182887A2 (en)

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US2047010A (en) * 1935-01-30 1936-07-07 Fairleigh S Dickinson Automatic syringe injector
US2295849A (en) * 1940-10-25 1942-09-15 Gustave L Kayden Attachment for hypodermic syringes
US2531267A (en) * 1947-10-16 1950-11-21 Harnisch Fritz Hypodermic syringe operating device
US5241969A (en) * 1992-06-10 1993-09-07 Carson Jay W Controlled and safe fine needle aspiration device
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