WO2017134966A1 - Puncture device and method for retaining cannula - Google Patents

Puncture device and method for retaining cannula Download PDF

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Publication number
WO2017134966A1
WO2017134966A1 PCT/JP2016/088779 JP2016088779W WO2017134966A1 WO 2017134966 A1 WO2017134966 A1 WO 2017134966A1 JP 2016088779 W JP2016088779 W JP 2016088779W WO 2017134966 A1 WO2017134966 A1 WO 2017134966A1
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WO
WIPO (PCT)
Prior art keywords
main body
puncture
housing
puncture needle
cannula
Prior art date
Application number
PCT/JP2016/088779
Other languages
French (fr)
Japanese (ja)
Inventor
隆弘 大越
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2017565433A priority Critical patent/JP6763890B2/en
Publication of WO2017134966A1 publication Critical patent/WO2017134966A1/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
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Definitions

  • the present invention relates to a puncture device including a puncture needle that is punctured into a living body and a method for placing a cannula.
  • Patent Document 1 describes an administration device having a cradle that can be attached to a living body, a double-structured puncture device including an inner needle and a cannula, and an insertion device for inserting the cannula into the living body.
  • the insertion device of the administration device includes a biasing member that applies a biasing force to the puncture device in a direction in which the puncture device projects from the cradle.
  • the inserter is removed from the cradle while the cannula is held in the cradle attached to the living body. After that, by attaching a storage unit storing a predetermined drug solution or the like to the cradle, the drug solution can be delivered into the living body via the cannula.
  • the cannula needs to be securely placed in the living body.
  • the cannula is prevented from falling off the cradle by engaging the cannula with a protrusion provided on the portion of the cradle that holds the cannula.
  • the above-described engagement between the cannula and the protrusion is performed when the cannula gets over the protrusion using a part of the urging force applied to the puncture tool when the puncture tool is punctured into the living body by the inserter.
  • the cannula receives a force from the protrusion due to contact with the protrusion, and thus cannot always be maintained in a posture perpendicular to the skin.
  • the cannula cannot be securely placed in the living body because the cannula is pierced obliquely into the skin or the engagement with the protrusion is insufficient.
  • the contact of the cannula with the protrusion before reaching the skin makes it difficult to predict the urging force to be applied to the puncture device, making it difficult to design the urging member in the puncture device.
  • An object of the present invention is to provide a puncture device and a cannula indwelling method that can securely indwell a cannula with respect to a living body.
  • a puncture device accommodates the puncture needle, a puncture needle comprising a main body that can be attached to the surface of a living body, a cannula and an inner needle inserted into the cannula.
  • a housing and a puncture mechanism that is provided in the housing and performs a puncture operation that allows the inner needle to be removed from the main body while the cannula is projected after the puncture needle protrudes from the main body
  • a fixing mechanism for fixing the cannula to the main body in a state where the puncture needle protrudes from the main body.
  • the puncture mechanism includes a puncture needle holding portion including a first holding portion that holds the cannula and a second holding portion that holds the inner needle, and a biasing force in a protruding direction that causes the puncture needle to protrude from the main body portion. And an urging member applied to the puncture needle holding unit.
  • the fixing mechanism includes an engaging portion that engages the first holding portion with the main body portion as the first holding portion moves relative to the main body portion in a direction different from the protruding direction. Is provided.
  • the cannula indwelling method according to the present invention for achieving the above object is a method in which the cannula is indwelled on a living body in a state of being fixed to the living body surface.
  • a cannula indwelling method according to the present invention includes a puncture needle including the cannula and an inner needle inserted into the cannula, a main body that can be attached to the surface of the living body, and a first holding unit that holds the cannula. And a puncture needle holding portion including a second holding portion that holds the inner needle, and a biasing member that applies a biasing force in a protruding direction that causes the puncture needle to protrude from the main body portion to the puncture needle holding portion.
  • the urging force of the urging member is released by moving the housing relative to the main body in a direction different from the projecting direction.
  • the housing is relative to the main body portion in a direction different from the protruding direction.
  • a third step of engaging the engaging part provided in the first holding part with the engaging part provided in the main body part, and the engaging part of the first holding part And the engagement portion of the main body portion are engaged with each other by moving the housing relative to the main body portion in a direction different from the projecting direction. Release the connection with the main unit, and With serial within the needle and the second holding portion, further comprising a fourth step of the separable from said main body portion.
  • the puncture device has the fixing mechanism that fixes the first holding portion to the main body in a state where the puncture needle protrudes from the main body.
  • the fixing mechanism includes an engaging portion that engages the first holding portion with the main body portion.
  • the engaging portion engages the first holding portion with the main body portion in accordance with the movement of the first holding portion relative to the main body portion in a direction different from the protruding direction of the puncture needle. Accordingly, since the operation of projecting the puncture needle from the main body portion and the operation of fixing the first holding portion to the main body portion can be performed independently, the puncture needle holding portion is operated in the operation of projecting the puncture needle from the main body portion. It is possible to avoid receiving a force from the engaging portion.
  • a force for engaging the first holding part with the main body part can be independently applied to the first holding part. Therefore, in a state where the puncture needle protrudes from the main body portion, the first holding portion that holds the puncture needle can be reliably fixed to the main body portion. Therefore, it is possible to provide a puncture device that can securely place a cannula with respect to a living body.
  • the operation of causing the puncture needle to protrude from the main body portion and the operation of fixing the first holding portion to the main body portion can be performed independently. It is possible to avoid the puncture needle holding part from receiving a force from the engaging part in the projecting operation. In addition to the urging force applied to the puncture needle holding part by the urging member, a force for engaging the first holding part with the main body part can be independently applied to the first holding part. Therefore, in a state where the puncture needle protrudes from the main body portion, the first holding portion that holds the puncture needle can be reliably fixed to the main body portion. Therefore, it is possible to provide a cannula placement method that can securely place a cannula with respect to a living body.
  • FIG. 3A is a plan view showing the mounting portion
  • FIG. 3B is a rear view showing the mounting portion
  • FIG. 3C is a right side view showing the mounting portion.
  • FIG. 5A is a perspective view showing the first member of the casing attached to the mounting portion
  • FIG. 5B shows the first member of the casing attached to the mounting portion from another angle.
  • FIG. 6A is an enlarged view of a region 6A shown in FIG. 5A, and FIG.
  • FIG. 6B is an enlarged view of a region 6B shown in FIG. 5B.
  • FIG. 7A is a perspective view showing the second member of the casing attached to the mounting portion
  • FIG. 7B shows the second member of the casing attached to the mounting portion from another angle.
  • FIG. 8A is an enlarged view of the region 8A shown in FIG. 7A
  • FIG. 8B is an enlarged view of the region 8B shown in FIG. 7B.
  • 10A is a perspective view showing the first holding part of the puncture needle holding part
  • FIG. 10B is a cross-sectional view taken along the line 10B-10B shown in FIG. 10A.
  • FIG. 11A is a perspective view of the second holding portion of the puncture needle holding portion, and FIG. 11B shows the second holding portion in a state where the engagement between the lock arm and the main member is released in the second holding portion.
  • FIG. 11C is a cross-sectional view taken along line 11C-11C shown in FIG. 11A.
  • 12A is an enlarged view of a region 12A shown in FIG. 11C
  • FIG. 12B is an enlarged view showing a main part in a cross section taken along line 12B-12B shown in FIG. 11A.
  • 13A is a cross-sectional view taken along line 13A-13A shown in FIG. 1, and FIG. 13B is a cross-sectional view corresponding to FIG. 13A in a state in which the puncture needle protrudes.
  • FIG. 14A is a cross-sectional view taken along line 14A-14A shown in FIG. 1, and FIG. 14B is a cross-sectional view corresponding to FIG. 14A in a state where the puncture needle protrudes.
  • FIG. 14A is a cross-sectional view corresponding to FIG. 14A showing a state where the housing is separated from the main body in a state where the second holding part of the puncture needle holding part of the puncture device according to the present embodiment releases the first holding part.
  • FIG. 16A is a perspective view showing the inside of the housing
  • FIG. 16B is a perspective view showing the inside of the housing in a state where the second holding portion of the puncture needle holding portion is housed in the housing. is there. It is a bottom view which shows a housing
  • casing is a bottom view which shows a housing
  • FIG. 19A is a perspective view showing a housing that accommodates the puncture needle holder before the puncture needle protrudes
  • FIG. 19B shows a housing that accommodates the puncture needle holder when the puncture needle protrudes
  • FIG. 19C is a perspective view showing a housing that accommodates the puncture needle holder after the puncture needle protrudes.
  • 20A is a perspective view showing the relationship between the first holding portion of the puncture needle holding portion and the main body before the puncture needle protrudes
  • FIG. 20B is the first view when the puncture needle protrudes.
  • FIG. 20C is an enlarged view of a region 20 ⁇ / b> C in FIG. 20B showing a state where the first holding part and the main body part engage with each other.
  • FIG. 21A is a plan view showing the main part before the first holding part and the main body part are engaged
  • FIG. 21B shows the main part in a state where the first holding part and the main body part are engaged.
  • FIG. 22A is a perspective view of the safety cap of the puncture apparatus according to the embodiment
  • FIG. 22B is a perspective view of the safety cap as seen from the direction of the arrow shown in FIG.
  • FIG. 14 is a partial perspective view showing the puncture apparatus according to the embodiment, with a part thereof taken along the line 23-23 shown in FIG. FIG.
  • FIG. 24A is a schematic diagram illustrating a state in which the safety cap is attached to the housing of the puncture apparatus according to the embodiment
  • FIG. 24B is a state in FIG. 24A in a state after the safety cap is attached to the housing.
  • FIG. 24 is a sectional view taken along line 24B-24B shown in FIG.
  • FIG. 25A is a perspective view showing a state in which the housing is rotated to project the puncture needle in the puncture device according to the embodiment
  • FIG. 26A is a perspective view showing a state in which the housing is rotated to separate the housing of the puncture device according to the embodiment from the main body
  • FIG. 26B is a diagram of the housing of the puncture device according to the embodiment. It is a perspective view which shows a mode that it isolate
  • FIG. 1 and 2 are a perspective view and an exploded perspective view of the puncture device 100 according to the present embodiment
  • FIG. 3 is a diagram mainly used for explaining the configuration of the mounting portion 18 of the main body 10 of the puncture device 100
  • 4 to 8 are diagrams mainly used for explaining the configuration of the casing 30 of the puncture device 100
  • FIGS. 9 to 19 are diagrams mainly used for explaining the configuration and operation of the puncture mechanism 110 of the puncture device 100
  • 20 and 21 are diagrams for explaining the configuration and operation of the fixing mechanism 120 of the puncture device 100
  • FIGS. 22 to 24 are diagrams for explaining the configuration and operation of the safety cap 40 of the puncture device 100.
  • FIG. 25 to 29 are diagrams for explaining an example of use of the puncture apparatus 100.
  • FIG. 1 and 2 are a perspective view and an exploded perspective view of the puncture device 100 according to the present embodiment
  • FIG. 3 is a diagram mainly used for explaining the configuration of the mounting portion 18 of the main body 10 of the puncture device
  • the puncture apparatus 100 can be used with a predetermined delivery mechanism 200 for delivering a drug solution (insulin) or the like (see FIG. 27).
  • the puncture device 100 and the delivery mechanism 200 can configure an administration device that administers a drug solution into the living body.
  • the puncture device 100 includes a main body 10 that can be attached to the surface of a living body, a puncture needle 20, a housing 30 that accommodates the puncture needle 20, and a safety cap 40.
  • the puncture needle 20 includes a cannula 21 and an inner needle 22 inserted into the cannula 21.
  • the puncture device 100 is provided in the housing 30, and after the puncture needle 20 protrudes from the main body portion 10, the inner needle 22 is removed from the main body portion 10 with the cannula 21 protruding. It further includes a puncture mechanism 110 that performs a puncturing operation that enables the puncturing operation.
  • the puncture mechanism 110 includes a puncture needle holding portion 111 including a first holding portion 130 that holds the cannula 21 and a second holding portion 140 that holds the inner needle 22, and a protruding direction Z that causes the puncture needle 20 to protrude from the main body portion 10. And an urging member 112 for applying an urging force to the puncture needle holding unit 111.
  • the puncture device 100 further includes a fixing mechanism 120 that fixes the cannula 21 to the main body 10 in a state where the puncture needle 20 protrudes from the main body 10.
  • the fixing mechanism 120 is an engaging portion that engages the first holding portion 130 with the main body portion 10 as the first holding portion 130 moves relative to the main body portion 10 in a direction different from the protruding direction Z. 150.
  • the puncture device 100 is provided in a state in which a safety cap 40 is attached to a housing 30 connected to the main body unit 10.
  • the main body 10 can be attached to a desired location where the cannula 21 is desired to be placed in the living body.
  • the housing 30 becomes rotatable relative to the main body portion 10 with the protruding direction Z of the puncture needle 20 as an axis.
  • the puncture needle 20 protrudes, the cannula 21 is fixed to the main body 10, and the connection between the main body 10 and the housing 30 is released. Is performed continuously.
  • the puncture device 100 has an advantage of being excellent in safety, convenience, and operability. Below, the puncture apparatus 100 is demonstrated in detail.
  • the main body 10 includes an attachment portion 16 on which an attachment portion 16 that can be attached to a living body and a delivery mechanism 200 that delivers a predetermined dose into the living body via a cannula 21 can be attached.
  • 18 and is configured as a cradle.
  • a known resin material or metal material can be used as a material constituting each part of the main body (cradle) 10.
  • the attachment part 16 of the main body part 10 is provided on the bottom surface 11 (see FIG. 2) arranged to face the skin surface of the living body when the apparatus is used.
  • the adhering portion 16 is constituted by a double-sided tape attached to the bottom surface 11 so as to extend outward from the bottom surface 11.
  • size, a shape, a configuration form, etc. are not specifically limited. For example, it can be formed by applying an adhesive or the like to the bottom surface 11.
  • the mounting portion 18 of the main body 10 includes a mounting surface 12 formed in a planar shape and a side wall 13 that partially surrounds the outer periphery of the mounting surface 12. Yes.
  • the delivery mechanism 200 can be disposed after the housing 30 is removed from the main body 10 (see FIG. 27).
  • the mounting surface 12 is formed with an insertion hole 12a through which the puncture needle 20 can be inserted.
  • the side wall 13 prevents the displacement of the delivery mechanism 200 disposed on the placement surface 12 and the drop-off from the main body 10.
  • the side wall 13 of the main body 10 has a first side wall 13 a extending in one direction along the outer periphery of the mounting surface 12 and an outer periphery of the mounting surface 12.
  • a second side wall 13b extending in the other direction intersecting with one direction along the third side wall 13c extending along the outer periphery of the mounting surface 12 so as to face the first side wall 13a,
  • the first side wall 13a is formed with a first opening 13a1 into which a first lock claw 37a of a second member 35 of the casing 30 described later is inserted and removed.
  • the second side wall 13b is formed with a second opening 13b1 into which the second lock claw 37b of the second member 35 is inserted and removed.
  • the puncture needle 20 includes a cannula 21 and an inner needle 22 inserted into the cannula 21.
  • the cannula 21 and the inner needle 22 can be configured by, for example, a known hollow needle having a flow path formed therein.
  • the outer diameter, the inner diameter, the length dimension, and the like of the cannula 21 and the inner needle 22 only need to be able to puncture a living body, and any one according to the intended use can be used.
  • the cannula 21 is configured as a cannula that introduces a medical solution such as insulin into the living body while being punctured into the living body.
  • the cannula 21 has a cylindrical shape and a truncated cone shape formed continuously with the cylindrical shape, and the cylindrical shape and the truncated cone shape have continuous lumens through which a drug solution flows. Is formed.
  • the cannula 21 is configured to have a so-called funnel-like shape by having the above-described shape.
  • the cannula 21 is formed of a resin material, for example.
  • the resin material for forming the cannula 21 for example, polyurethane, nylon, ethylene-tetrafluoroethylene copolymer (ETFE), or the like can be used.
  • the inner needle 22 is formed of, for example, a metal material.
  • a metal material for forming the inner needle 22 for example, stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, or the like can be used.
  • the housing 30 is configured to be connectable and detachable to the main body 10. As shown in FIGS. 2 and 4, the housing 30 includes a first member 31 that accommodates the puncture mechanism 110, and a first member with the protruding direction Z of the puncture needle 20 as an axis in a state of covering the first member 31. And a second member 35 that is rotatably attached to 31.
  • the first member 31 extends from the substantially cylindrical cylindrical body 32 and the outer peripheral surface 32 a of the cylindrical body 32, and the first member 31 is connected to the main body 10.
  • a leg portion 33 that abuts against the placement surface 12 of the mounting portion 18.
  • the outer peripheral surface 32 a of the cylindrical body 32 forms a guide surface that guides the rotation of the second member 35 relative to the first member 31 about the protruding direction Z of the puncture needle 20.
  • the leg portion 33 includes a first recess 33 a into which the first side wall 13 a of the mounting portion 18 is inserted in a state where the first member 31 is connected to the mounting portion 18, and And a second recess 33b into which the second side wall 13b of the mounting portion 18 is inserted in a state where the one member 31 is connected to the mounting portion 18.
  • the second member 35 includes a first cylindrical body 36 having a substantially cylindrical shape having an inner diameter substantially equal to or slightly larger than the outer diameter of the cylindrical body 32 of the first member 31.
  • the second member 35 is disposed closer to the mounting portion 18 than the first cylindrical body 36, and has an outer diameter larger than the outer diameter of the first cylindrical body 36. Puncture with respect to the first cylindrical body 36 and the second cylindrical body 37, the cylindrical second cylindrical body 37, the connecting portion 38 that connects the first cylindrical body 36 and the second cylindrical body 37, And a knob 39 for applying a rotational force with the protruding direction Z of the needle 20 as an axis.
  • the second cylindrical body 37 has a first lock claw that is inserted into and removed from the first opening 13 a 1 of the mounting portion 18 according to the rotation of the second member 35.
  • 37a and a second lock claw 37b in which the mounting portion 18 is inserted into and removed from the second opening 13b1 in accordance with the rotation of the second member 35.
  • the first lock claw 37 a and the second lock claw 37 b have an arc shape extending along the outer peripheral surface 37 c of the second cylinder 37.
  • the first lock claw 37a and the second lock claw 37b are inserted into and removed from the first opening 13a1 and the second opening 13b1 of the mounting portion 18 in the direction intersecting the surface direction of the placement surface 12, respectively.
  • the movement of the second member 35 can be restricted and the restriction can be released.
  • the puncture mechanism 110 applies to the puncture needle holding portion 111 a puncture needle holding portion 111 that holds the puncture needle 20 and a biasing force in the protruding direction Z of the puncture needle 20. And an urging member 112.
  • the puncture needle holding unit 111 includes a first holding unit 130 that holds the cannula 21 and a second holding unit 140 that holds the inner needle 22.
  • the puncture needle holding part 111 is accommodated in the housing 30 in a state where it can move in the protruding direction Z of the puncture needle 20.
  • the first holding unit 130 includes a base 131 that holds a portion of the cannula 21 in a protruding state, and a liquid supply pipe 222 that supplies a chemical solution from the outside of the first holding unit 130 (FIG. 29).
  • a connection port 132 having a lumen 132a to be inserted, a cap 133 attached so as to cover the connection port 132, and a base 131 attached to a side different from the side holding the cannula 21
  • a lid member 134 and a seal member 135 provided between the base 131 and the lid member 134 are provided.
  • the base portion 131 is a portion that becomes a base of the first holding portion 130, and is configured in a substantially cylindrical shape in the present embodiment.
  • the base 131 includes an internal space 131 a in which the cannula 21 is installed.
  • the internal space 131 a is configured to have a funnel shape in accordance with the shape of the cannula 21 so that the cannula 21 can be supported.
  • a recess 136 is provided on the outer periphery of the base 131 in which the arm 143 of the second holding unit 140 of the puncture mechanism 110 is engaged.
  • connection port 132 extends in the base 131 in a direction intersecting with the cylindrical axis of the cannula 21.
  • the lumen 132a of the connection port 132 and the internal space 131a of the base 131 communicate with each other.
  • the cap 133 is preferably formed of a material having the following characteristics. That is, (i) the liquid feeding pipe 222 that supplies the chemical solution from the outside of the first holding unit 130 can be inserted, and (ii) the liquid feeding pipe 222 and the connection port 132 are inserted in a liquid-tight manner. (Iii) The hole formed in the cap 133 by inserting the liquid feeding pipe 222 is formed of a material having the characteristics that it is closed after the liquid feeding pipe 222 is removed. It is preferable. Examples of the material having such characteristics include rubber.
  • the lid member 134 has a function of pressing the seal member 135.
  • a through hole 137 through which the inner needle 22 can be inserted is formed in the lid member 134 coaxially with the axial direction of the cannula 21.
  • the seal member 135 is configured so that the inner needle 22 can be inserted, and prevents the insulin from leaking out from the through hole 137 after the inner needle 22 is removed from the through hole 137.
  • Examples of the material of the seal member 135 include rubber.
  • the second holding portion 140 has a main member 141 that holds the inner needle 22 and a plate-like shape that is separated from the main member 141 in the protruding direction Z of the inner needle 22.
  • the auxiliary member 142 includes a pair of arms 143 that are rotatably connected to the auxiliary member 142 to sandwich the first holding unit 130.
  • the second holding unit 140 is configured to set a distance h between the pair of connecting members 144 that connect each of the pair of arms 143 and the main member 141 and the main member 141 and the sub member 142 in the protruding direction Z of the inner needle 22.
  • a lock arm 145 that maintains a predetermined size.
  • the main member 141 has a plate-like base material 141a and a holding portion 141b for holding the inner needle 22.
  • the holding portion 141b protrudes with a cylindrical shape from a surface different from the surface facing the sub member 142 in the base material 141a.
  • the method for holding the inner needle 22 by the holding portion 141b is not particularly limited.
  • the holding portion 141b holds the inner needle 22 in a state where the inner needle 22 is inserted into the lumen 141c of the holding portion 141b.
  • the lumen 141c and the inner needle 22 are bonded by an adhesive.
  • each of the pair of arms 143 includes an engaging claw 143a that engages with the recess 136 of the first holding unit 130.
  • the engaging claw 143a is provided at a position separated from the connection portion 143b connected to the sub member 142 in the arm 143.
  • the distance d between the engaging claws 143a of the pair of arms 143 changes as the arm 143 rotates with the connection portion 143b between the arm 143 and the sub member 142 as a fulcrum.
  • the pair of arms 143 can switch between a state in which the first holding unit 130 is held and a state in which the holding of the first holding unit 130 is released.
  • the connecting member 144 connects the main member 141 with a location 143c different from the location where the engagement claw 143a is provided in the arm 143 and the connection location 143b connected to the sub member 142.
  • the lock arm 145 includes an engaging claw 145c that is rotatably connected to the sub member 142 at one end 145a and that engages with the main member 141 at the other end 145b.
  • the engagement claw 145c of the lock arm 145 is engaged with the main member 141, the distance h between the main member 141 and the sub member 142 in the protruding direction Z of the inner needle 22 is maintained at a predetermined size.
  • the rotation of the arm 143 using the connection portion 143b connected to the sub member 142 in the arm 143 as a fulcrum is restricted.
  • the urging member 112 applies an urging force in the protruding direction Z of the puncture needle 20 to the puncture needle holding part 111 in the housing 30.
  • the cylindrical body 32 of the first member 31 of the housing 30 includes a support portion 32 b that supports one end portion 112 a of the urging member 112 and the protruding direction of the puncture needle 20. And a protrusion 32c that restricts the movement of the urging member 112 in the direction crossing Z.
  • the connecting member 144 of the second holding portion 140 has an end portion 112 b different from the end portion 112 a supported by the support portion 32 b in the biasing member 112.
  • the support part 144a which supports is provided.
  • the urging member 112 is supported between the support part 32b on the housing 30 side and the support part 144a on the puncture needle holding part 111 side. Since the puncture needle holding part 111 is accommodated in the housing 30 in a state where it can move in the protruding direction Z of the puncture needle 20, the support part 32b on the housing 30 side and the support part 144a on the puncture needle holding part 111 side are arranged. The distance between them can be shorter than the natural length of the biasing member 112.
  • the distance between the support portion 32b on the housing 30 side and the support portion 144a on the puncture needle holding portion 111 side is made shorter than the natural length of the biasing member 112, so that the support portion 32b and the puncture needle on the housing 30 side A biasing force is applied from the biasing member 112 to the support portion 144a on the holding portion 111 side.
  • the movement of the casing 30 in the protruding direction Z of the puncture needle 20 is restricted in a state where the casing 30 is connected to the main body 10. Therefore, the housing 30 does not move in the protruding direction Z of the puncture needle 20 due to the urging force applied from the urging member 112 to the support portion 32b on the housing 30 side.
  • the puncture needle holding part 111 is movable in the protruding direction Z of the puncture needle 20 in the state accommodated in the housing 30. Therefore, the puncture needle holding part 111 moves in the protruding direction Z of the puncture needle 20 by the urging force applied from the urging member 112 to the support part 144a on the puncture needle holding part 111 side.
  • the puncture needle 20 passes through the insertion hole 12 a formed in the placement surface 12 of the main body 10 and protrudes from the main body 10.
  • the cylindrical body 32 of the first member 31 of the housing 30 guides the movement of the puncture needle holding unit 111 along the protruding direction Z of the puncture needle 20.
  • a groove 32d is further provided.
  • the puncture needle holding part 111 is accommodated in the housing 30 in a state where the side surface 143d (see FIG. 11A) of the arm 143 of the second holding part 140 faces the side surface 32e of the guide groove 32d.
  • the puncture needle holding unit 111 moves in the protruding direction Z of the puncture needle 20 by the urging force applied by the urging member 112 while the side surface 143d of the arm 143 of the second holding unit 140 is guided by the side surface 32e of the guide groove 32d.
  • the cylindrical body 32 of the first member 31 of the housing 30 abuts on each of the pair of lock arms 145 of the second holding unit 140, thereby each of the pair of lock arms 145.
  • the lock wall 32f contacts each of the pair of lock arms 145 in a state before the puncture needle 20 protrudes from the main body 10 (for example, the state shown in FIG. 13A).
  • the puncture needle 20 protrudes from the main body 10 (for example, the state shown in FIG. 13B)
  • the contact between each of the pair of lock arms 145 and the lock wall 32f is released.
  • each of the pair of lock arms 145 is engaged with the main member 141 of the second holding unit 140 before the puncture needle 20 protrudes.
  • the combined state is maintained. Thereby, the state in which the arm 143 of the second holding unit 140 sandwiches the first holding unit 130 in the state before the puncture needle 20 protrudes is maintained.
  • the lock wall 32f cancels the state where it abuts on each of the pair of lock arms 145 in a state where the puncture needle 20 protrudes from the main body portion 10.
  • the state in which each of the pair of lock arms 145 of the second holding part 140 is engaged with the main member 141 of the second holding part 140 is released, so that the main member 141 and the auxiliary member in the protruding direction Z of the inner needle 22 are released.
  • the distance h between the member 142 is larger than a predetermined size. Therefore, the state where the arm 143 of the second holding unit 140 holds the first holding unit 130 is released.
  • the housing 30 can be separated from the main body 10 in a state where the first holding portion 130 remains in the main body 10.
  • the puncture mechanism 110 further includes a restricting portion 113 that restricts the movement of the puncture needle holding portion 111 against the biasing force applied by the biasing member 112. Then, the restriction by the restriction portion 113 is released in conjunction with an operation in which the housing 30 rotates relative to the main body portion 10 about the protruding direction Z of the puncture needle 20.
  • the restricting portion 113 is punctured against the first restricting portion 113a that maintains the state where the puncture needle 20 does not protrude against the biasing force applied by the biasing member 112 and the biasing force that the biasing member 112 applies. And a second restricting portion 113b for maintaining the protruding amount of the needle 20 at a predetermined size.
  • the main member 141 of the second holding unit 140 further includes a column 141d that protrudes from a surface different from the surface of the main member 141 that faces the sub member 142.
  • the 1st control part 113a is equipped with the shape protruded in a mutually different direction from the outer peripheral surface 141e of the support
  • the second restricting portion 113b protrudes in pairs in different directions from the outer peripheral surface 141e of the support post 141d along the direction intersecting the protruding direction Z of the inner needle 22 and the protruding direction of the first restricting portion 113a. It has a shape.
  • the second restricting portion 113b is formed away from the first restricting portion 113a in a direction different from the protruding direction Z of the puncture needle 20 on the outer peripheral surface 141e of the support post 141d.
  • a concave portion 39 a that is recessed in the protruding direction Z of the puncture needle 20 is formed at the top of the knob portion 39 of the second member 35 of the housing 30. And the recessed part 39a contacts the 1st control part 113a and the 2nd control part 113b, and the control surface 39b which controls the movement of the 1st control part 113a and the 2nd control part 113b in the protrusion direction Z of the puncture needle 20 At the bottom of the recess 39a.
  • the keyhole 39c comprised so that the 1st control part 113a can move is formed in the control surface 39b.
  • the housing 30 in a state in which the puncture needle holding unit 111 is accommodated is viewed in plan view from the protruding direction Z of the puncture needle 20, the outline of the first restriction part 113a, the outline of the second restriction part 113b, and the outline of the key hole 39c It has substantially the same shape.
  • the first restricting portion 113a is in contact with the restricting surface 39b when the puncture needle 20 is not protruding. At this time, the position of the key hole 39c formed in the restricting surface 39b is shifted from the position of the first restricting portion 113a. As a result, the puncture needle holder 111 applied with the urging force by the urging member 112 is restricted from moving in the protruding direction Z of the puncture needle 20.
  • the restriction surface 39b is formed.
  • the position of the key hole 39c matches the position of the first restricting portion 113a.
  • the 1st control part 113a can move to the protrusion direction Z of the puncture needle 20 through the keyhole 39c.
  • the puncture needle holding portion 111 moves in the protruding direction Z of the puncture needle 20 and the puncture needle 20 protrudes from the main body portion 10 (see FIGS. 13B and 14B).
  • the second restricting portion 113b contacts the restricting surface 39b in a state where the puncture needle 20 protrudes.
  • the position of the second restricting portion 113b is shifted from the position of the key hole 39c. Therefore, the second restricting portion 113b does not pass through the keyhole 39c when the puncture needle 20 protrudes.
  • the fixing mechanism 120 includes the first holding unit 130 in accordance with the movement of the first holding unit 130 relative to the main body unit 10 in a direction different from the protruding direction Z.
  • An engaging portion 150 that engages the holding portion 130 with the main body portion 10 is provided.
  • the engaging part 150 includes a first engaging part 151 provided on the first holding part 130 side and a second engaging part 152 provided on the main body part 10 side and engaged with the first engaging part 151. Prepare.
  • the first engaging portions 151 are provided so as to protrude from the outer peripheral surface of the base 131 of the first holding portion 130 in different directions along the direction intersecting the protruding direction Z of the puncture needle 20. It is done.
  • the first engaging portion 151 includes a base 151 a that protrudes from the outer peripheral surface of the base portion 131 of the first holding portion 130, and an engaging claw 151 b that is provided to protrude from the base 151 a along the outer peripheral surface of the base portion 131.
  • the second engagement portion 152 includes a base 152 a that protrudes from the placement surface 12 in a direction opposite to the protruding direction Z of the puncture needle 20, and a base that extends in a direction that intersects the protruding direction Z of the puncture needle 20. It has an engaging claw 152b that protrudes from the base 152a on the top side of the base 152a and engages with the engaging claw 151b of the first engaging part 151 of the first holding part 130 in a state where the puncture needle 20 protrudes.
  • the first holding part 130 and the main body part 10 are engaged by rotating the first holding part 130 relative to the main body part 10 about the protruding direction Z of the puncture needle 20.
  • the first holding part 130 and the main body part 10 are first held in conjunction with an operation in which the housing 30 rotates relative to the main body part 10 about the protruding direction Z of the puncture needle 20.
  • the part 130 is engaged by rotating relative to the main body part 10.
  • the second restriction formed in the second holding portion 140 of the puncture needle holding portion 111 is formed in the concave portion 39 a of the second member 35 of the housing 30.
  • a protrusion 39d is provided that applies a rotational force about the protruding direction Z of the puncture needle 20 to the second holding portion 140.
  • the guide groove 32d formed in the first member 31 of the housing 30 is formed on the second holding portion 140 of the puncture needle holding portion 111 in a state where the puncture needle 20 protrudes. It is not provided at a position facing the arm 143. As a result, the puncture needle holding portion 111 is rotatable in the housing 30 around the protruding direction Z of the puncture needle 20 when the puncture needle 20 is projected.
  • the second holding unit 140 is rotated in accordance with the operation of rotating the second member 35 relative to the first member 31 in a state where the puncture needle 20 protrudes. .
  • the first holding portion 130 held by the second holding portion 140 is also rotated, and the first engaging portion 151 provided on the first holding portion 130 side is engaged.
  • the claw 151b and the engagement claw 152b of the second engagement portion 152 provided on the main body 10 side are engaged.
  • the mechanism 120 includes the following. That is, since the operation of projecting the puncture needle 20 from the main body 10 and the operation of fixing the first holding unit 130 to the main body 10 can be performed independently, the operation of projecting the puncture needle 20 from the main body 10 is possible. It is possible to avoid the puncture needle holding part 111 from receiving a force from the engaging part 150. In addition to the urging force applied to the puncture needle holding unit 111 by the urging member 112, a force for engaging the first holding unit 130 with the main body unit 10 can be independently applied to the first holding unit 130. Therefore, the first holding part 130 that holds the puncture needle 20 can be reliably fixed to the main body part 10 in a state where the puncture needle 20 protrudes from the main body part 10.
  • the housing 30 and the main body 10 are connected to each other with the engaging portion 150 engaged with the main body 10 and the first holding portion 130 with the protruding direction Z of the puncture needle 20 as an axis. Is released by rotating relative to the main body 10.
  • the first lock claw 37 a and the second lock claw 37 b of the second member 35 of the housing 30 are configured so that the main body 10 and the first holding part 130 are engaged with each other in the engaging part 150.
  • the second member 35 rotates relative to the main body 10 in the engaged state, the second member 35 has a predetermined length so as to be separated from the first opening 13a1 and the second opening 13b1 of the side wall 13 of the main body 10. It is formed with.
  • the connection between the housing 30 and the main body 10 is established in the engagement portion 150 between the main body 10 and the first holding portion.
  • the housing 30 is released by rotating relative to the main body 10 in a state in which the housing 130 is engaged.
  • the first holding part 130 can be fixed to the main body part 10 and the housing 30 and the main body part 10 can be connected to each other by a simple single operation of rotating the housing 30 relative to the main body part 10. Release can be performed continuously.
  • first lock claw 37 a and the second lock claw 37 b are not changed until the main body portion 10 and the first holding portion 130 are engaged in the engagement portion 150.
  • the first lock claw 37a and the second lock claw 37b have a length that maintains the state in which they are inserted into the first opening 13a1 and the second opening 13b1. Thereby, it is possible to prevent the connection between the housing 30 and the main body 10 before the main body 10 and the first holding part 130 are engaged in the engaging part 150.
  • safety cap 40 is configured to be connectable / separable to housing 30 and restricts rotation of housing 30 with respect to main body 10 in a state of being connected to housing 30.
  • the safety cap 40 is a protrusion inserted between the wall surface 39e (see FIG. 18) of the concave portion 39a of the knob portion 39 of the second member 35 and the second restricting portion 113b of the second holding portion 140 of the puncture needle holding portion 111. 40a.
  • the protrusion 40a is inserted between the wall surface 39e of the concave portion 39a of the second member 35 and the second restricting portion 113b of the second holding portion 140 of the puncture needle holding portion 111, whereby the second member 35 with respect to the first member 31 is inserted. Rotation is regulated. Thereby, it can prevent that the housing
  • the safety cap 40 is configured to be attachable to the housing 30 in a state where the inner needle 22 removed from the cannula 21 is covered after the housing 30 is separated from the main body portion 10.
  • the safety cap 40 includes an engaging claw 40 b that engages with the first member 31 of the housing 30.
  • an opening 33 c that engages with an engaging claw 40 b of the safety cap 40 is provided in the leg portion 33 of the first member 31 of the housing 30.
  • the safety cap 40 is attached to the housing 30 by the engagement claw 40 b of the safety cap 40 engaging with the opening 33 c.
  • the attachment portion 16 of the main body portion 10 is attached to a desired location where the cannula 21 is to be placed.
  • the safety cap 40 attached to the housing 30 is removed. Thereby, the second member 35 of the housing 30 can be rotated with respect to the first member 31.
  • the first lock claw 37a and the second lock claw 37b of the second member 35 are disengaged from the first opening 13a1 and the second opening 13b1 of the mounting portion 18.
  • the second member 35 is rotated relative to the first member 31 using the knob 39 in the direction (see FIG. 8A).
  • the relative rotation of the second member 35 with respect to the first member 31 is formed in the position of the key hole 39c formed in the concave portion 39a of the second member 35 and the column 141d of the second holding portion 140 of the puncture needle holding portion 111. This is performed until the position of the first restricting portion 113a matches (see FIG. 19B).
  • the first lock claw 37a and the second lock claw 37b of the second member 35 are moved away from the first opening 13a1 and the second opening 13b1.
  • the second member 35 is further rotated relative to the first member 31.
  • the second restricting portion 113b formed on the support post 141d of the second holding portion 140 of the puncture needle holding portion 111 is pressed by the protrusion 39d formed on the concave portion 39a of the second member 35 (FIG. 19 ( C)).
  • the puncture needle holding part 111 is rotated around the protruding direction Z of the puncture needle 20.
  • the first engagement portion 151 of the first holding unit 130 of the puncture needle holding unit 111 and the main body unit 10 are rotated.
  • the second engaging portion 152 is engaged (see FIG. 20C).
  • the first holding part 130 is fixed to the main body part 10.
  • the cannula 21 is reliably placed in the living body while being held by the first holding unit 130.
  • the first member 31 moves in the direction in which the first lock claw 37a and the second lock claw 37b are detached from the first opening 13a1 and the second opening 13b1.
  • the second member 35 is further rotated relatively.
  • the first lock claw 37a and the second lock claw 37b are detached from the first opening 13a1 and the second opening 13b1.
  • intersects the surface direction of the mounting surface 12 is cancelled
  • connection between the main body 10 and the housing 30 is released by pulling up the housing 30 in the direction opposite to the protruding direction Z of the puncture needle 20.
  • the safety cap 40 removed from the housing 30 is attached to the housing 30. Specifically, by engaging the engaging claw 40b formed on the safety cap 40 with the opening 33c formed on the leg portion 33 of the first member 31 of the housing 30, the safety cap 40 is mounted on the housing. 30 (see FIGS. 4 and 24B). Thereby, the erroneous puncture by the puncture needle 20 after the housing
  • the sending mechanism 200 is attached to the main body 10.
  • the first holding part 130 is left in the main body 10.
  • the delivery mechanism 200 for administering a predetermined dose to the first holding unit 130, the inside of the cannula 21 is connected via the inner cavity 131 a of the connection port 132 of the first holding unit 130 and the inner space 131 a of the base 131.
  • the dose can be delivered to As a result, the administration product can be delivered into the living body via the cannula 21 held in the internal space 131a of the base 131.
  • the delivery mechanism 200 to be used is not particularly limited as long as a predetermined dose can be fed into the cannula 21, but for example, as shown in FIGS. 27 and 28, it is necessary for the liquid feeding operation.
  • a liquid feeding reuse unit 210 including a driving mechanism 211 that generates a driving force for driving various members and a liquid feeding disposable unit 220 including a drug solution storage unit 221 filled with insulin are used.
  • the liquid feed reuse unit 210 and the liquid feed disposable unit 220 are configured to be connected and separated.
  • the liquid delivery reuse part 210 and the liquid delivery disposable part 220 are separated, and the liquid delivery disposable part 220 is made disposable and replaced with a new one.
  • the liquid supply reuse unit 210 is mounted with relatively expensive components such as a motor 211a and a gear 211b, which will be described later, which are less expensive to replace than components mounted on the liquid supply disposable unit 220.
  • a component member discarded after use for a predetermined period and a relatively expensive component member are mounted in different housings, respectively, and the relatively expensive component member is mounted in the liquid feeding reuse unit 210 and can be reused. By doing so, it is possible to reduce the manufacturing cost of the apparatus and the cost associated with use.
  • the liquid supply reuse unit 210 includes a drive mechanism 211 that drives members necessary for performing the liquid supply operation, a control unit 212 that controls the drive mechanism 211, and a first housing 213 that holds these.
  • a part surrounded by a dotted line X represents a part attached to the liquid feeding reuse part 210
  • a part surrounded by a one-dot chain line Y represents a part attached to the liquid feeding disposable part 220.
  • the first housing 213 is omitted for easy understanding.
  • the drive mechanism 211 includes a motor 211a having an output shaft that generates rotation by the electric power from the battery 224 of the liquid delivery disposable unit 220, and a speed reduction generated by the motor 211a to the extrusion mechanism 223 of the liquid delivery disposable unit 220.
  • the liquid delivery disposable unit 220 includes a drug solution storage unit 221 filled with a drug solution (insulin or the like) as an administration, a lumen 132a of the connection port 132 of the first holding unit 130, and a drug solution storage unit.
  • a liquid supply pipe 222 that communicates with 221; a push mechanism 211 that is mechanically connected to the drive mechanism 211 to push the insulin in the drug solution storage unit 221 to the liquid supply pipe 222; and a battery that supplies power to the drive mechanism 211 and the like 224 and a second housing 225 for holding them.
  • the administration is not limited to a drug solution, and may be any as long as it is intended for administration into a living body, and the administration state may be liquid, gas, solid (for example, powder) , Granular material), gel and the like.
  • the liquid feeding tube 222 is constituted by a metal thin tube having a sharp tip shape, for example.
  • the sharp tip of the liquid feeding tube 222 passes through the cap 133 of the first holding unit 130, and the liquid feeding tube 222 is inserted into the inner cavity 132 a of the connection port 132. That is, while performing the operation of connecting the delivery mechanism 200 to the main body unit 10, the liquid supply tube 222 and the connection port 132 are connected, and the assembly operation is performed so that the chemical solution can be fed into the first holding unit 130. be able to.
  • the push-out mechanism 223 includes a slide part 226 that can move forward and backward in the internal space of the chemical solution storage part 221, and a feed screw that meshes with a female screw formed on the slide part 226 to move the slide part 226 forward and backward. 227 and a gear 228 that meshes with the gear 211b of the drive mechanism 211 and is connected to the feed screw 227.
  • the slide part 226 includes a push plate 226a capable of moving forward and backward in the chemical liquid storage part 221 while maintaining a sealing property so that the chemical liquid does not leak to the slide part 226 side, and a feed plate in which a female screw that meshes with the feed screw 227 is formed. 226b and a connecting plate 226c for connecting the push member 226a and the feed plate 226b.
  • the feed screw 227 After connecting the liquid feeding pipe 222 and the connection port 132, the feed screw 227 is rotated via the gear 211b of the drive mechanism 211 and the gear 223c of the push-out mechanism 223 by driving the motor 211a of the drive mechanism 211. As the feed screw 227 rotates, the feed plate 226b moves along the helical axis of the male screw of the feed screw 227. The pushing member 226a connected to the feed plate 226b through the connecting plate 226c moves in the chemical solution storage unit 221 as the feed plate 226b moves.
  • the extruding member 226a moves in a direction in which the pusher member 226a is pushed into the medicinal solution storage unit 221 (a direction in which the volume of the containing space decreases)
  • the dose in the containing space formed by the medicinal solution storage unit 221 and the pushing member 226a is transferred to the liquid feeding tube 222.
  • the liquid is sent to Insulin fed to the liquid feeding tube 222 is introduced into the living body (indicated by reference symbol P in FIG. 29) via the inner cavity 132a of the connection port 132, the inner space 131a of the base 131, and the cannula 21.
  • the puncture device 100 from which the housing 30 is removed and the predetermined delivery mechanism 200 can constitute an administration device that administers the administration into the living body, and administration of the administration using this administration device. It becomes possible to do.
  • the puncture apparatus 100 has the fixing mechanism 120 that fixes the first holding unit 130 to the main body 10 in a state where the puncture needle 20 protrudes from the main body 10.
  • the fixing mechanism 120 includes an engaging portion 150 that engages the first holding portion 130 with the main body portion 10.
  • the engaging portion 150 moves the first holding portion 130 to the main body portion 10 in accordance with an operation in which the first holding portion 130 moves relative to the main body portion 10 in a direction different from the protruding direction Z of the puncture needle 20. Engage with.
  • maintenance part 130 to the main-body part 10 can be performed independently, the operation
  • the puncture needle holding part 111 can be prevented from receiving a force from the engaging part 150.
  • a force for engaging the first holding unit 130 with the main body unit 10 can be independently applied to the first holding unit 130.
  • the first holding part 130 that holds the puncture needle 20 can be reliably fixed to the main body part 10 in a state where the puncture needle 20 protrudes from the main body part 10. Therefore, it is possible to provide a puncture device that can securely place a cannula with respect to a living body.
  • the engaging portion 150 is provided on the first holding portion 130 side and the main body portion 10 side, and is engaged with the first engaging portion 151.
  • the first holding part 130 and the main body part 10 are relative to the main body part 10 about the protruding direction Z of the puncture needle 20. Engaged by rotating in an automatic manner. Thereby, the first holding unit 130 can be engaged with the main body unit 10 by a simple operation of rotating the first holding unit 130. Therefore, the operability when using the puncture device is improved.
  • the housing 30 is configured to be connectable and detachable from the main body 10 by rotating relative to the main body 10.
  • the first holding portion 130 and the main body portion 10 are interlocked with an operation in which the housing 30 rotates relative to the main body portion 10 about the protruding direction Z of the puncture needle 20.
  • the first holding part 130 is engaged by rotating relative to the main body part 10.
  • the connection between the main body 10 and the housing 30 is such that the housing 30 is the main body about the protruding direction Z of the puncture needle 20 when the first holding portion 130 and the main body 10 are engaged in the engaging portion 150. It is released by rotating relative to the part 10.
  • the first holding part 130 can be fixed to the main body part 10 and the housing 30 and the main body part 10 can be connected to each other by a simple single operation of rotating the housing 30 relative to the main body part 10. Release can be performed continuously. Therefore, the operability when using the puncture device is further improved.
  • the puncture mechanism 110 further includes a restricting portion 113 that restricts the movement of the puncture needle holding portion against the urging force. Then, the restriction by the restriction portion 113 is released in conjunction with an operation in which the housing 30 rotates relative to the main body portion 10 with the protruding direction Z as an axis. Thereby, the puncture of the puncture needle 20 into the living body and the fixing of the first holding unit 130 to the main body 10 by a simple one-time operation of rotating the housing 30 relative to the main body 10. The connection between the casing 30 and the main body 10 can be released continuously. Therefore, the operability when using the puncture device is further improved.
  • the puncture apparatus 100 is configured to be connectable / separable to the housing 30, and further includes a safety cap 40 that regulates the rotation of the housing 30 relative to the main body 10 when connected to the housing 30.
  • a safety cap 40 that regulates the rotation of the housing 30 relative to the main body 10 when connected to the housing 30.
  • the safety cap 40 is configured to be attachable to the housing 30 in a state of covering the inner needle 22 removed from the cannula 21 after the housing 30 is separated from the main body portion 10. The Thereby, the erroneous puncture by the puncture needle 20 after the housing
  • the main body 10 includes the attachment portion 16 to which the attachment portion 16 that can be attached to a living body and the delivery mechanism 200 that sends a predetermined dose into the living body via the cannula 21 can be attached.
  • the puncture device according to the present invention has been described based on the embodiment, the puncture device according to the present invention is not limited to the configuration described in the embodiment, and may be appropriately changed based on the description of the scope of claims. Is possible.
  • the first holding part 130 and the main body part 10 are engaged when the first holding part 130 rotates relative to the main body part 10 about the protruding direction Z of the puncture needle 20.
  • the operation of engaging the first holding portion with the main body is not limited as long as the first holding portion is an operation that moves relative to the main body in a direction different from the protruding direction of the puncture needle.
  • the engaging part is configured so that the first holding part and the main body part engage with the movement of the first holding part relative to the main body part in the surface direction of the mounting surface of the mounting part. It may be configured.
  • the engaging portion 150 is provided on the first holding portion 130 side and the main body portion 10 side, and engages with the first engaging portion 151. And a second engaging portion 152.
  • the configuration of the engaging portion is as long as the first holding portion engages with the main body portion in accordance with the movement of the first holding portion relative to the main body portion in a direction different from the protruding direction. It is not limited.
  • the engaging portion engages with a first engaging portion provided on the first holding portion side, a second engaging portion provided on the main body portion side, the first engaging portion and the second engaging portion.
  • An engagement member, and the first engagement portion and the second engagement portion may be configured to engage with each other via the engagement member.
  • the protruding direction of the puncture needle can be arbitrarily set as long as the cannula can be fixed to the main body in a state where the cannula protrudes from the main body.
  • the angle formed by the protruding direction of the puncture needle and the mounting surface can be set to an arbitrary angle including a vertical angle.

Abstract

[Problem] To provide a puncture device and a method for implanting a cannula, whereby a cannula can be reliably implanted in a living body. [Solution] A puncture device has: a main body 10 capable of being affixed to the surface of a living body; a puncture needle provided with a cannula and an inner needle inserted in the cannula; a housing for accommodating the puncture needle; a puncture mechanism for performing a puncture operation for making it possible to withdraw the inner needle from the main body with the cannula still protruding after the puncture needle is caused to protrude from the main body, the puncture mechanism being provided in the housing; and a fixing mechanism 120 for fixing the cannula to the main body in a state in which the puncture needle is caused to protrude from the main body. The puncture mechanism is provided with a puncture needle retaining part including a first retaining part 130 and a second retaining part for retaining the inner needle, and an urging member for imparting to the puncture needle retaining part an urging force in the protrusion direction in which the puncture needle is caused to protrude from the main body. The fixing mechanism is provided with an engaging part 150 for engaging the first retaining part with the main body in conjunction with the operation whereby the first retaining part moves relative to the main body in a direction other than the protrusion direction.

Description

穿刺装置およびカニューレの留置方法Puncture device and cannula placement method
 本発明は、生体に穿刺される穿刺針を備える穿刺装置およびカニューレの留置方法に関する。 The present invention relates to a puncture device including a puncture needle that is punctured into a living body and a method for placing a cannula.
 従来、インスリンなどの薬液を生体内へ投与するために使用される装置として、使用者の皮膚に付着させて用いられる携帯型の投与装置が知られている。例えば、特許文献1には、生体に貼り付け可能なクレードルと、内針とカニューレとからなる二重構造の穿刺具と、カニューレを生体に挿入するための挿入器と、を有する投与装置が記載されている。当該投与装置の挿入器は、クレードルから穿刺具を突出させる方向に向けて当該穿刺具に付勢力を付与する付勢部材を備えている。 2. Description of the Related Art Conventionally, as a device used to administer a drug solution such as insulin into a living body, a portable administration device used by being attached to a user's skin is known. For example, Patent Document 1 describes an administration device having a cradle that can be attached to a living body, a double-structured puncture device including an inner needle and a cannula, and an insertion device for inserting the cannula into the living body. Has been. The insertion device of the administration device includes a biasing member that applies a biasing force to the puncture device in a direction in which the puncture device projects from the cradle.
 上述した投与装置では、挿入器を使用して穿刺具を生体に穿刺した後、生体に貼り付けられたクレードルにカニューレを保持させた状態で当該挿入器をクレードルから取り外す。その後、所定の薬液等が貯蔵された貯蔵部をクレードルに装着させることにより、カニューレを介して生体内へ薬液を送出することを可能にする。ここで、カニューレを介して薬液を生体内へ持続的に安定して送出するためには、カニューレが生体に確実に留置されている必要がある。上述した投与装置では、クレードルにおいてカニューレを保持する部分に設けられた突起にカニューレが係合することによってクレードルからのカニューレの脱落が防止される。 In the administration device described above, after inserting the puncture device into the living body using the inserter, the inserter is removed from the cradle while the cannula is held in the cradle attached to the living body. After that, by attaching a storage unit storing a predetermined drug solution or the like to the cradle, the drug solution can be delivered into the living body via the cannula. Here, in order to continuously and stably deliver the drug solution into the living body through the cannula, the cannula needs to be securely placed in the living body. In the administration device described above, the cannula is prevented from falling off the cradle by engaging the cannula with a protrusion provided on the portion of the cradle that holds the cannula.
特表2010-531197号公報Japanese translation of PCT publication 2010-531197
 しかしながら、上述したカニューレと突起との係合は、挿入器によって穿刺具が生体に穿刺される際に、穿刺具に付与される付勢力の一部を利用してカニューレが突起を乗り越えることによってなされる。突起を乗り越える過程で、カニューレは、突起と接触することに起因して突起からも力を受けるため、皮膚に対して垂直な姿勢に維持されるとは必ずしも言えない。その結果、カニューレが皮膚に斜めに穿刺されたり、突起との係合が不十分となったりするなど、生体への確実なカニューレ留置ができない可能性がある。また、カニューレが皮膚に到達する前に突起と接触することは、穿刺具に付与すべき付勢力を予測しにくくし、穿刺装置における付勢部材の設計を困難にするという問題があった。 However, the above-described engagement between the cannula and the protrusion is performed when the cannula gets over the protrusion using a part of the urging force applied to the puncture tool when the puncture tool is punctured into the living body by the inserter. The In the process of getting over the protrusion, the cannula receives a force from the protrusion due to contact with the protrusion, and thus cannot always be maintained in a posture perpendicular to the skin. As a result, there is a possibility that the cannula cannot be securely placed in the living body because the cannula is pierced obliquely into the skin or the engagement with the protrusion is insufficient. Further, the contact of the cannula with the protrusion before reaching the skin makes it difficult to predict the urging force to be applied to the puncture device, making it difficult to design the urging member in the puncture device.
 本発明の目的は、生体に対してカニューレを確実に留置できる穿刺装置およびカニューレの留置方法を提供することにある。 An object of the present invention is to provide a puncture device and a cannula indwelling method that can securely indwell a cannula with respect to a living body.
 上記目的を達成するための本発明に係る穿刺装置は、生体表面に貼り付け可能な本体部と、カニューレと当該カニューレ内に挿入された内針とを備える穿刺針と、前記穿刺針を収容する筐体と、前記筐体内に設けられ、前記穿刺針を前記本体部から突出させた後、前記カニューレを突出させたまま、前記内針を前記本体部から抜去可能にする穿刺動作を行う穿刺機構と、前記穿刺針が前記本体部から突出された状態において前記カニューレを前記本体部に固定する固定機構と、を有する。前記穿刺機構は、前記カニューレを保持する第1保持部および前記内針を保持する第2保持部を含む穿刺針保持部と、前記穿刺針を前記本体部から突出させる突出方向の付勢力を前記穿刺針保持部に付与する付勢部材と、を備える。前記固定機構は、前記第1保持部が前記本体部に対して前記突出方向とは異なる方向に相対的に移動する動作に伴って当該第1保持部を当該本体部に係合する係合部を備える。 In order to achieve the above object, a puncture device according to the present invention accommodates the puncture needle, a puncture needle comprising a main body that can be attached to the surface of a living body, a cannula and an inner needle inserted into the cannula. A housing and a puncture mechanism that is provided in the housing and performs a puncture operation that allows the inner needle to be removed from the main body while the cannula is projected after the puncture needle protrudes from the main body And a fixing mechanism for fixing the cannula to the main body in a state where the puncture needle protrudes from the main body. The puncture mechanism includes a puncture needle holding portion including a first holding portion that holds the cannula and a second holding portion that holds the inner needle, and a biasing force in a protruding direction that causes the puncture needle to protrude from the main body portion. And an urging member applied to the puncture needle holding unit. The fixing mechanism includes an engaging portion that engages the first holding portion with the main body portion as the first holding portion moves relative to the main body portion in a direction different from the protruding direction. Is provided.
 上記目的を達成するための本発明に係るカニューレの留置方法は、カニューレを、生体表面に固定した状態で生体に対して留置する方法である。本発明に係るカニューレの留置方法は、前記カニューレと前記カニューレ内に挿入された内針とを備える穿刺針と、前記生体表面に貼り付け可能な本体部と、前記カニューレを保持する第1保持部および前記内針を保持する第2保持部を含む穿刺針保持部と、前記穿刺針を前記本体部から突出させる突出方向の付勢力を前記穿刺針保持部に付与する付勢部材と、が設けられた筐体と、を有する穿刺装置の前記本体部を前記生体表面に貼り付ける第1のステップを含む。本発明に係るカニューレの留置方法は、前記筐体を、前記本体部に対して前記突出方向とは異なる方向に相対的に移動させることによって、前記付勢部材の付勢力を開放して、前記穿刺針を前記本体部から突出させる第2のステップと、前記本体部から前記穿刺針を突出させた状態において、前記筐体を、前記本体部に対して前記突出方向とは異なる方向に相対的に移動させることによって、前記第1保持部に設けられた係合部と前記本体部に設けられた係合部とを係合させる第3のステップと、前記第1保持部の前記係合部と前記本体部の前記係合部とを係合させた状態において、前記筐体を、前記本体部に対して前記突出方向とは異なる方向に相対的に移動させることによって、前記筐体と前記本体部との接続を解除して、前記筐体を、前記内針および前記第2保持部とともに、前記本体部から分離可能にする第4のステップと、をさらに含む。 The cannula indwelling method according to the present invention for achieving the above object is a method in which the cannula is indwelled on a living body in a state of being fixed to the living body surface. A cannula indwelling method according to the present invention includes a puncture needle including the cannula and an inner needle inserted into the cannula, a main body that can be attached to the surface of the living body, and a first holding unit that holds the cannula. And a puncture needle holding portion including a second holding portion that holds the inner needle, and a biasing member that applies a biasing force in a protruding direction that causes the puncture needle to protrude from the main body portion to the puncture needle holding portion. A first step of affixing the body portion of the puncture device having the housing to the surface of the living body. In the cannula indwelling method according to the present invention, the urging force of the urging member is released by moving the housing relative to the main body in a direction different from the projecting direction. In the second step of causing the puncture needle to protrude from the main body portion, and in a state in which the puncture needle is protruded from the main body portion, the housing is relative to the main body portion in a direction different from the protruding direction. A third step of engaging the engaging part provided in the first holding part with the engaging part provided in the main body part, and the engaging part of the first holding part And the engagement portion of the main body portion are engaged with each other by moving the housing relative to the main body portion in a direction different from the projecting direction. Release the connection with the main unit, and With serial within the needle and the second holding portion, further comprising a fourth step of the separable from said main body portion.
 本発明に係る穿刺装置によれば、穿刺針が本体部から突出された状態において第1保持部を本体部に固定する固定機構を有する。固定機構は、第1保持部を本体部に係合する係合部を含む。そして、係合部は、第1保持部が本体部に対して穿刺針の突出方向とは異なる方向に相対的に移動する動作に伴って第1保持部を本体部に係合する。これにより、穿刺針を本体部から突出させる動作と第1保持部を本体部に固定する動作とを独立して行うことができるから、穿刺針を本体部から突出させる動作において穿刺針保持部が係合部から力を受けることを回避できる。そして、付勢部材によって穿刺針保持部に付与される付勢力とは別に、第1保持部を本体部に係合させる力を第1保持部に独立して付与できる。そのため、本体部から穿刺針が突出した状態において、穿刺針を保持する第1保持部を本体部に確実に固定できる。従って、生体に対してカニューレを確実に留置できる穿刺装置を提供できる。 The puncture device according to the present invention has the fixing mechanism that fixes the first holding portion to the main body in a state where the puncture needle protrudes from the main body. The fixing mechanism includes an engaging portion that engages the first holding portion with the main body portion. The engaging portion engages the first holding portion with the main body portion in accordance with the movement of the first holding portion relative to the main body portion in a direction different from the protruding direction of the puncture needle. Accordingly, since the operation of projecting the puncture needle from the main body portion and the operation of fixing the first holding portion to the main body portion can be performed independently, the puncture needle holding portion is operated in the operation of projecting the puncture needle from the main body portion. It is possible to avoid receiving a force from the engaging portion. In addition to the urging force applied to the puncture needle holding part by the urging member, a force for engaging the first holding part with the main body part can be independently applied to the first holding part. Therefore, in a state where the puncture needle protrudes from the main body portion, the first holding portion that holds the puncture needle can be reliably fixed to the main body portion. Therefore, it is possible to provide a puncture device that can securely place a cannula with respect to a living body.
 本発明に係るカニューレの留置方法によれば、穿刺針を本体部から突出させる動作と第1保持部を本体部に固定する動作とを独立して行うことができるから、穿刺針を本体部から突出させる動作において穿刺針保持部が係合部から力を受けることを回避できる。そして、付勢部材によって穿刺針保持部に付与される付勢力とは別に、第1保持部を本体部に係合させる力を第1保持部に独立して付与できる。そのため、本体部から穿刺針が突出した状態において、穿刺針を保持する第1保持部を本体部に確実に固定できる。従って、生体に対してカニューレを確実に留置できるカニューレの留置方法を提供できる。 According to the indwelling method of the cannula according to the present invention, the operation of causing the puncture needle to protrude from the main body portion and the operation of fixing the first holding portion to the main body portion can be performed independently. It is possible to avoid the puncture needle holding part from receiving a force from the engaging part in the projecting operation. In addition to the urging force applied to the puncture needle holding part by the urging member, a force for engaging the first holding part with the main body part can be independently applied to the first holding part. Therefore, in a state where the puncture needle protrudes from the main body portion, the first holding portion that holds the puncture needle can be reliably fixed to the main body portion. Therefore, it is possible to provide a cannula placement method that can securely place a cannula with respect to a living body.
実施形態に係る穿刺装置を示す斜視図である。It is a perspective view which shows the puncture apparatus which concerns on embodiment. 実施形態に係る穿刺装置を示す分解斜視図である。It is a disassembled perspective view which shows the puncture apparatus which concerns on embodiment. 図3(A)は装着部を示す平面図、図3(B)は装着部を示す背面図、図3(C)は装着部を示す右側面図である。3A is a plan view showing the mounting portion, FIG. 3B is a rear view showing the mounting portion, and FIG. 3C is a right side view showing the mounting portion. 実施形態に係る穿刺装置の筐体を示す分解斜視図である。It is a disassembled perspective view which shows the housing | casing of the puncture apparatus which concerns on embodiment. 図5(A)は装着部に取り付けられた状態の筐体の第1部材を示す斜視図、図5(B)は装着部に取り付けられた状態の筐体の第1部材を別の角度から示す斜視図である。5A is a perspective view showing the first member of the casing attached to the mounting portion, and FIG. 5B shows the first member of the casing attached to the mounting portion from another angle. It is a perspective view shown. 図6(A)は図5(A)中に示す領域6Aの拡大図、図6(B)は図5(B)中に示す領域6Bの拡大図。6A is an enlarged view of a region 6A shown in FIG. 5A, and FIG. 6B is an enlarged view of a region 6B shown in FIG. 5B. 図7(A)は装着部に取り付けられた状態の筐体の第2部材を示す斜視図、図7(B)は装着部に取り付けられた状態の筐体の第2部材を別の角度から示す斜視図である。FIG. 7A is a perspective view showing the second member of the casing attached to the mounting portion, and FIG. 7B shows the second member of the casing attached to the mounting portion from another angle. It is a perspective view shown. 図8(A)は図7(A)中に示す領域8Aの拡大図、図8(B)は図7(B)中に示す領域8Bの拡大図である。8A is an enlarged view of the region 8A shown in FIG. 7A, and FIG. 8B is an enlarged view of the region 8B shown in FIG. 7B. 実施形態に係る穿刺装置の穿刺針保持部を示す斜視図である。It is a perspective view which shows the puncture needle holding | maintenance part of the puncture apparatus which concerns on embodiment. 図10(A)は穿刺針保持部の第1保持部を示す斜視図、図10(B)は、図10(A)中に示す10B-10B線に沿う断面図である。10A is a perspective view showing the first holding part of the puncture needle holding part, and FIG. 10B is a cross-sectional view taken along the line 10B-10B shown in FIG. 10A. 図11(A)は穿刺針保持部の第2保持部の斜視図、図11(B)は第2保持部においてロックアームと主部材との係合が解除された状態の第2保持部を示す斜視図、図11(C)は図11(A)中に示す11C-11C線に沿う断面図である。FIG. 11A is a perspective view of the second holding portion of the puncture needle holding portion, and FIG. 11B shows the second holding portion in a state where the engagement between the lock arm and the main member is released in the second holding portion. FIG. 11C is a cross-sectional view taken along line 11C-11C shown in FIG. 11A. 図12(A)は図11(C)中に示す領域12Aの拡大図、図12(B)は図11(A)中に示す12B-12B線に沿う断面における要部を示す拡大図である。12A is an enlarged view of a region 12A shown in FIG. 11C, and FIG. 12B is an enlarged view showing a main part in a cross section taken along line 12B-12B shown in FIG. 11A. . 図13(A)は図1中に示す13A-13A線に沿う断面図、図13(B)は穿刺針が突出した状態における図13(A)に対応する断面図である。13A is a cross-sectional view taken along line 13A-13A shown in FIG. 1, and FIG. 13B is a cross-sectional view corresponding to FIG. 13A in a state in which the puncture needle protrudes. 図14(A)は図1中に示す14A-14A線に沿う断面図、図14(B)は穿刺針が突出した状態における図14(A)に対応する断面図である。14A is a cross-sectional view taken along line 14A-14A shown in FIG. 1, and FIG. 14B is a cross-sectional view corresponding to FIG. 14A in a state where the puncture needle protrudes. 本実施形態に係る穿刺装置の穿刺針保持部の第2保持部が第1保持部の挟持を解除した状態において筐体が本体部から分離される様子を示す図14(A)に対応する断面図である。FIG. 14A is a cross-sectional view corresponding to FIG. 14A showing a state where the housing is separated from the main body in a state where the second holding part of the puncture needle holding part of the puncture device according to the present embodiment releases the first holding part. FIG. 図16(A)は筐体の内部を示す斜視図、図16(B)は筐体の内部に穿刺針保持部の第2保持部が収容された状態における筐体の内部を示す斜視図である。16A is a perspective view showing the inside of the housing, and FIG. 16B is a perspective view showing the inside of the housing in a state where the second holding portion of the puncture needle holding portion is housed in the housing. is there. 筐体を示す底面図である。It is a bottom view which shows a housing | casing. 本実施形態に係る穿刺装置の筐体の第2部材を示す斜視図である。It is a perspective view which shows the 2nd member of the housing | casing of the puncture apparatus which concerns on this embodiment. 図19(A)は穿刺針が突出する前の状態における穿刺針保持部を収容した筐体を示す斜視図、図19(B)は穿刺針が突出する際の穿刺針保持部を収容した筐体を示す斜視図、図19(C)は穿刺針が突出した後における穿刺針保持部を収容した筐体を示す斜視図である。FIG. 19A is a perspective view showing a housing that accommodates the puncture needle holder before the puncture needle protrudes, and FIG. 19B shows a housing that accommodates the puncture needle holder when the puncture needle protrudes. FIG. 19C is a perspective view showing a housing that accommodates the puncture needle holder after the puncture needle protrudes. 図20(A)は穿刺針が突出する前の状態における穿刺針保持部の第1保持部と本体部との関係を示す斜視図、図20(B)は穿刺針が突出した状態における第1保持部と本体部との関係を示す斜視図、図20(C)は第1保持部と本体部とが係合する様子を示す図20(B)中の領域20Cの拡大図である。20A is a perspective view showing the relationship between the first holding portion of the puncture needle holding portion and the main body before the puncture needle protrudes, and FIG. 20B is the first view when the puncture needle protrudes. FIG. 20C is an enlarged view of a region 20 </ b> C in FIG. 20B showing a state where the first holding part and the main body part engage with each other. 図21(A)は第1保持部と本体部とが係合する前の要部を示す平面図、図21(B)は第1保持部と本体部とが係合した状態における要部を示す平面図である。FIG. 21A is a plan view showing the main part before the first holding part and the main body part are engaged, and FIG. 21B shows the main part in a state where the first holding part and the main body part are engaged. FIG. 図22(A)は実施形態に係る穿刺装置のセーフティキャップの斜視図、図22(B)は図22(A)中に示す矢印方向から見たセーフティキャップの斜視図である。FIG. 22A is a perspective view of the safety cap of the puncture apparatus according to the embodiment, and FIG. 22B is a perspective view of the safety cap as seen from the direction of the arrow shown in FIG. 実施形態に係る穿刺装置を図13中に示す23-23線に沿って一部を断面にして示す部分斜視図である。FIG. 14 is a partial perspective view showing the puncture apparatus according to the embodiment, with a part thereof taken along the line 23-23 shown in FIG. 図24(A)は実施形態に係る穿刺装置の筐体にセーフティキャップを取り付ける様子を示す模式図、図24(B)は筐体にセーフティキャップを取り付けた後の状態における図24(A)中に示す24B-24B線に沿う断面図である。FIG. 24A is a schematic diagram illustrating a state in which the safety cap is attached to the housing of the puncture apparatus according to the embodiment, and FIG. 24B is a state in FIG. 24A in a state after the safety cap is attached to the housing. FIG. 24 is a sectional view taken along line 24B-24B shown in FIG. 図25(A)は実施形態に係る穿刺装置において穿刺針を突出させるために筐体を回転させる様子を示す斜視図、図25(B)は穿刺針を突出させた状態において穿刺針保持部の第1保持部を本体部に固定させるために筐体を回転させる様子を示す斜視図である。FIG. 25A is a perspective view showing a state in which the housing is rotated to project the puncture needle in the puncture device according to the embodiment, and FIG. 25B shows the puncture needle holding unit in a state in which the puncture needle is projected. It is a perspective view which shows a mode that a housing | casing is rotated in order to fix a 1st holding | maintenance part to a main-body part. 図26(A)は実施形態に係る穿刺装置の筐体を本体部から分離させるために筐体を回転させる様子を示す斜視図、図26(B)は実施形態に係る穿刺装置の筐体を本体部から分離させる様子を示す斜視図である。FIG. 26A is a perspective view showing a state in which the housing is rotated to separate the housing of the puncture device according to the embodiment from the main body, and FIG. 26B is a diagram of the housing of the puncture device according to the embodiment. It is a perspective view which shows a mode that it isolate | separates from a main-body part. 投与物を送出するための送出機構を本体部に取り付ける際の様子を示す斜視図である。It is a perspective view which shows a mode at the time of attaching the delivery mechanism for delivering a dosage to a main-body part. 投与物を送出するための送出機構における各部の構造を示す概略平面図である。It is a schematic plan view which shows the structure of each part in the delivery mechanism for delivering a dosage. 図28の29-29線に沿う断面図であって、図29(A)は、注入部と送液部を接続する前の状態を示す図、図29(B)は、注入部と送液部を接続した状態を示す図である。29A and 29B are cross-sectional views taken along line 29-29 in FIG. 28, in which FIG. 29A shows a state before the injection section and the liquid feeding section are connected, and FIG. 29B shows the injection section and the liquid feeding section. It is a figure which shows the state which connected the part.
 以下、添付した図面を参照しながら、本発明の実施形態を説明する。なお、以下の記載
は特許請求の範囲に記載される技術的範囲や用語の意義を限定するものではない。また、
図面の寸法比率は説明の都合上誇張されており、実際の比率とは異なる場合がある。
Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the technical scope and terms used in the claims. Also,
The dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.
 図1および図2は本実施形態に係る穿刺装置100の斜視図および分解斜視図であり、図3は主に穿刺装置100の本体部10の装着部18の構成の説明に供する図であり、図4~8は主に穿刺装置100の筐体30の構成の説明に供する図であり、図9~19は主に穿刺装置100の穿刺機構110の構成および動作の説明に供する図であり、図20および図21は穿刺装置100の固定機構120の構成および動作の説明に供する図であり、図22~24は穿刺装置100のセーフティキャップ40の構成および動作の説明に供する図である。また、図25~29は穿刺装置100の使用例の説明に供する図である。 1 and 2 are a perspective view and an exploded perspective view of the puncture device 100 according to the present embodiment, and FIG. 3 is a diagram mainly used for explaining the configuration of the mounting portion 18 of the main body 10 of the puncture device 100. 4 to 8 are diagrams mainly used for explaining the configuration of the casing 30 of the puncture device 100, and FIGS. 9 to 19 are diagrams mainly used for explaining the configuration and operation of the puncture mechanism 110 of the puncture device 100. 20 and 21 are diagrams for explaining the configuration and operation of the fixing mechanism 120 of the puncture device 100, and FIGS. 22 to 24 are diagrams for explaining the configuration and operation of the safety cap 40 of the puncture device 100. FIG. 25 to 29 are diagrams for explaining an example of use of the puncture apparatus 100. FIG.
 本実施形態に係る穿刺装置100は、薬液(インスリン)などの投与物を送出するための所定の送出機構200とともに用いることができる(図27を参照)。そして、穿刺装置100および送出機構200によって薬液を生体内へ投与する投与装置を構成することが可能になっている。 The puncture apparatus 100 according to the present embodiment can be used with a predetermined delivery mechanism 200 for delivering a drug solution (insulin) or the like (see FIG. 27). The puncture device 100 and the delivery mechanism 200 can configure an administration device that administers a drug solution into the living body.
 図1、図2に示すように、穿刺装置100は、生体表面に貼り付け可能な本体部10と、穿刺針20と、穿刺針20を収容する筐体30と、セーフティキャップ40と、を有する。図9に示すように、穿刺針20は、カニューレ21と当該カニューレ21内に挿入された内針22とを備える。 As shown in FIGS. 1 and 2, the puncture device 100 includes a main body 10 that can be attached to the surface of a living body, a puncture needle 20, a housing 30 that accommodates the puncture needle 20, and a safety cap 40. . As shown in FIG. 9, the puncture needle 20 includes a cannula 21 and an inner needle 22 inserted into the cannula 21.
 図2に示すように、穿刺装置100は、筐体30内に設けられ、穿刺針20を本体部10から突出させた後、カニューレ21を突出させたまま、内針22を本体部10から抜去可能にする穿刺動作を行う穿刺機構110をさらに有する。穿刺機構110は、カニューレ21を保持する第1保持部130および内針22を保持する第2保持部140を含む穿刺針保持部111と、穿刺針20を本体部10から突出させる突出方向Zの付勢力を穿刺針保持部111に付与する付勢部材112と、を備える。 As shown in FIG. 2, the puncture device 100 is provided in the housing 30, and after the puncture needle 20 protrudes from the main body portion 10, the inner needle 22 is removed from the main body portion 10 with the cannula 21 protruding. It further includes a puncture mechanism 110 that performs a puncturing operation that enables the puncturing operation. The puncture mechanism 110 includes a puncture needle holding portion 111 including a first holding portion 130 that holds the cannula 21 and a second holding portion 140 that holds the inner needle 22, and a protruding direction Z that causes the puncture needle 20 to protrude from the main body portion 10. And an urging member 112 for applying an urging force to the puncture needle holding unit 111.
 図20(C)に示すように、穿刺装置100は、穿刺針20が本体部10から突出された状態においてカニューレ21を本体部10に固定する固定機構120をさらに有する。固定機構120は、第1保持部130が本体部10に対して突出方向Zとは異なる方向に相対的に移動する動作に伴って第1保持部130を本体部10に係合する係合部150を備える。 As shown in FIG. 20C, the puncture device 100 further includes a fixing mechanism 120 that fixes the cannula 21 to the main body 10 in a state where the puncture needle 20 protrudes from the main body 10. The fixing mechanism 120 is an engaging portion that engages the first holding portion 130 with the main body portion 10 as the first holding portion 130 moves relative to the main body portion 10 in a direction different from the protruding direction Z. 150.
 図1に示すように、穿刺装置100は、本体部10に接続された筐体30にセーフティキャップ40が取り付けられた状態において提供される。本体部10は、生体においてカニューレ21を留置したい所望の箇所に付着させることができる。セーフティキャップ40を取り外すと、筐体30は、本体部10に対して穿刺針20の突出方向Zを軸にして相対的に回転可能な状態になる。本体部10に対して筐体30を相対的に回転させる動作に連動して、穿刺針20の突出と、本体部10に対するカニューレ21の固定と、本体部10と筐体30との接続の解除が連続的に行われる。すなわち、本体部10に対して筐体30を相対的に回転させるという簡便な操作によって、生体への穿刺針20の穿刺と、穿刺針20の生体への確実な留置と、本体部10からの筐体30の取り外し作業と、を連続的に行うことができる。よって、穿刺装置100は、安全性、利便性および操作性に優れるといった優位性を備える。以下に、穿刺装置100について詳細に説明する。 As shown in FIG. 1, the puncture device 100 is provided in a state in which a safety cap 40 is attached to a housing 30 connected to the main body unit 10. The main body 10 can be attached to a desired location where the cannula 21 is desired to be placed in the living body. When the safety cap 40 is removed, the housing 30 becomes rotatable relative to the main body portion 10 with the protruding direction Z of the puncture needle 20 as an axis. In conjunction with the operation of rotating the housing 30 relative to the main body 10, the puncture needle 20 protrudes, the cannula 21 is fixed to the main body 10, and the connection between the main body 10 and the housing 30 is released. Is performed continuously. That is, by a simple operation of rotating the housing 30 relative to the main body 10, the puncture of the puncture needle 20 into the living body, the reliable placement of the puncture needle 20 in the living body, and the removal from the main body 10. The removal operation of the housing 30 can be performed continuously. Therefore, the puncture device 100 has an advantage of being excellent in safety, convenience, and operability. Below, the puncture apparatus 100 is demonstrated in detail.
 まず、穿刺装置100の全体構成について説明する。 First, the overall configuration of the puncture apparatus 100 will be described.
 図1、図2に示すように、本体部10は、生体に貼り付け可能な付着部16と、カニューレ21を介して所定の投与物を生体内へ送出する送出機構200が装着可能な装着部18と、を有するクレードルとして構成されている。本体部(クレードル)10の各部を構成する材料には、例えば、公知の樹脂材料や金属材料を使用することができる。 As shown in FIGS. 1 and 2, the main body 10 includes an attachment portion 16 on which an attachment portion 16 that can be attached to a living body and a delivery mechanism 200 that delivers a predetermined dose into the living body via a cannula 21 can be attached. 18 and is configured as a cradle. For example, a known resin material or metal material can be used as a material constituting each part of the main body (cradle) 10.
 本体部10の付着部16は、装置を使用する際に生体の皮膚表層に向かい合わせて配置される底面11(図2参照)に設けられている。この付着部16は、底面11の外方に延在するように底面11に取り付けた両面テープによって構成している。なお、付着部16は、本体部10が生体に付着可能に構成され得る限りにおいて設置場所、大きさ、形状、構成形態等は特に限定されない。例えば、底面11に接着剤等を塗布したりすることで形成することもできる。 The attachment part 16 of the main body part 10 is provided on the bottom surface 11 (see FIG. 2) arranged to face the skin surface of the living body when the apparatus is used. The adhering portion 16 is constituted by a double-sided tape attached to the bottom surface 11 so as to extend outward from the bottom surface 11. In addition, as long as the main-body part 10 can be comprised so that attachment to a living body can be comprised, the installation part, a magnitude | size, a shape, a configuration form, etc. are not specifically limited. For example, it can be formed by applying an adhesive or the like to the bottom surface 11.
 図2、図3に示すように、本体部10の装着部18は、平面状に形成された載置面12と、載置面12の外周を部分的に囲む側壁13と、を有している。載置面12上には、本体部10から筐体30を取り外した後において送出機構200を配置することが可能になっている(図27参照)。載置面12には、穿刺針20を挿通可能な挿通穴12aが形成されている。側壁13は、載置面12上に配置された送出機構200の位置ずれや本体部10からの脱落を防止する。 As shown in FIGS. 2 and 3, the mounting portion 18 of the main body 10 includes a mounting surface 12 formed in a planar shape and a side wall 13 that partially surrounds the outer periphery of the mounting surface 12. Yes. On the mounting surface 12, the delivery mechanism 200 can be disposed after the housing 30 is removed from the main body 10 (see FIG. 27). The mounting surface 12 is formed with an insertion hole 12a through which the puncture needle 20 can be inserted. The side wall 13 prevents the displacement of the delivery mechanism 200 disposed on the placement surface 12 and the drop-off from the main body 10.
 図3に示すように、本実施形態において、本体部10の側壁13は、載置面12の外周に沿って一の方向に延在する第1の側壁13aと、載置面12の外周に沿って一の方向に交差する他の方向に延在する第2の側壁13bと、第1の側壁13aに対向して載置面12の外周に沿って延在する第3の側壁13cと、を有する。 As shown in FIG. 3, in the present embodiment, the side wall 13 of the main body 10 has a first side wall 13 a extending in one direction along the outer periphery of the mounting surface 12 and an outer periphery of the mounting surface 12. A second side wall 13b extending in the other direction intersecting with one direction along the third side wall 13c extending along the outer periphery of the mounting surface 12 so as to face the first side wall 13a, Have
 第1の側壁13aには、後述する筐体30の第2部材35の第1のロック爪37aの挿入および離脱がなされる第1開口部13a1が形成されている。また、第2の側壁13bには、第2部材35の第2のロック爪37bの挿入および離脱がなされる第2開口部13b1が形成されている。 The first side wall 13a is formed with a first opening 13a1 into which a first lock claw 37a of a second member 35 of the casing 30 described later is inserted and removed. The second side wall 13b is formed with a second opening 13b1 into which the second lock claw 37b of the second member 35 is inserted and removed.
 次に、穿刺針20について説明する。 Next, the puncture needle 20 will be described.
 穿刺針20は、カニューレ21とカニューレ21内に挿入された内針22とを備える。カニューレ21および内針22は、例えば、内部に流路が形成された公知の中空針によって構成することができる。カニューレ21および内針22の外径、内径、長さ寸法等は、生体への穿刺が可能であればよく、使用される目的に応じた任意のものを使用することができる。 The puncture needle 20 includes a cannula 21 and an inner needle 22 inserted into the cannula 21. The cannula 21 and the inner needle 22 can be configured by, for example, a known hollow needle having a flow path formed therein. The outer diameter, the inner diameter, the length dimension, and the like of the cannula 21 and the inner needle 22 only need to be able to puncture a living body, and any one according to the intended use can be used.
 本実施形態において、カニューレ21は、生体に穿刺された状態においてインスリンなどの薬液を生体に導入するカニューレとして構成されている。図10(B)に示すように、カニューレ21は、円筒形状と当該円筒形状に連続して形成された円錐台形状を有し、円筒形状と円錐台形状には薬液を流通させる内腔が連続して形成されている。カニューレ21は、上記のような形状を備えることにより、いわゆる漏斗のような形状を備えるように構成している。カニューレ21は、例えば、樹脂材料によって形成される。カニューレ21を形成する樹脂材料として、例えば、ポリウレタン、ナイロン、エチレン-テトラフルオロエチレン共重合体(ETFE)などを使用することができる。 In the present embodiment, the cannula 21 is configured as a cannula that introduces a medical solution such as insulin into the living body while being punctured into the living body. As shown in FIG. 10 (B), the cannula 21 has a cylindrical shape and a truncated cone shape formed continuously with the cylindrical shape, and the cylindrical shape and the truncated cone shape have continuous lumens through which a drug solution flows. Is formed. The cannula 21 is configured to have a so-called funnel-like shape by having the above-described shape. The cannula 21 is formed of a resin material, for example. As the resin material for forming the cannula 21, for example, polyurethane, nylon, ethylene-tetrafluoroethylene copolymer (ETFE), or the like can be used.
 内針22は、例えば、金属材料によって形成される。内針22を形成する金属材料として、例えば、ステンレス鋼、アルミニウム、アルミニウム合金、チタン、チタン合金などを使用することができる。 The inner needle 22 is formed of, for example, a metal material. As a metal material for forming the inner needle 22, for example, stainless steel, aluminum, aluminum alloy, titanium, titanium alloy, or the like can be used.
 次に、筐体30について説明する。 Next, the housing 30 will be described.
 筐体30は、本体部10に接続・分離可能に構成される。図2、図4に示すように、筐体30は、穿刺機構110を収容する第1部材31と、第1部材31を覆った状態において穿刺針20の突出方向Zを軸にして第1部材31に対して相対的に回転自在に取り付けられる第2部材35と、を有する。 The housing 30 is configured to be connectable and detachable to the main body 10. As shown in FIGS. 2 and 4, the housing 30 includes a first member 31 that accommodates the puncture mechanism 110, and a first member with the protruding direction Z of the puncture needle 20 as an axis in a state of covering the first member 31. And a second member 35 that is rotatably attached to 31.
 図4、図5に示すように、第1部材31は、略円筒形状の筒体32と、筒体32の外周面32aから延出するとともに、第1部材31が本体部10に接続されたときに装着部18の載置面12に当接する脚部33と、を有する。筒体32の外周面32aは、穿刺針20の突出方向Zを軸にした第1部材31に対する第2部材35の回転をガイドするガイド面を形成している。 As shown in FIGS. 4 and 5, the first member 31 extends from the substantially cylindrical cylindrical body 32 and the outer peripheral surface 32 a of the cylindrical body 32, and the first member 31 is connected to the main body 10. A leg portion 33 that abuts against the placement surface 12 of the mounting portion 18. The outer peripheral surface 32 a of the cylindrical body 32 forms a guide surface that guides the rotation of the second member 35 relative to the first member 31 about the protruding direction Z of the puncture needle 20.
 図5、図6を参照して、脚部33は、第1部材31が装着部18に接続された状態において装着部18の第1の側壁13aが挿入される第1の凹部33aと、第1部材31が装着部18に接続された状態において装着部18の第2の側壁13bが挿入される第2の凹部33bと、を備える。第1の凹部33aに第1の側壁13aが挿入されることによって、第1の側壁13aの延在方向に交差する方向において第1部材31の移動が拘束される。また、第2の凹部33bに第2の側壁13bが挿入されることによって、第2の側壁13bの延在方向に交差する方向において第1部材31の移動が拘束される。その結果、第1部材31は、装着部18に接続された状態において、載置面12の面方向における移動および載置面12の面方向に交差する方向を軸とする回転方向の移動が拘束される。 Referring to FIGS. 5 and 6, the leg portion 33 includes a first recess 33 a into which the first side wall 13 a of the mounting portion 18 is inserted in a state where the first member 31 is connected to the mounting portion 18, and And a second recess 33b into which the second side wall 13b of the mounting portion 18 is inserted in a state where the one member 31 is connected to the mounting portion 18. By inserting the first side wall 13a into the first recess 33a, the movement of the first member 31 is restrained in the direction intersecting the extending direction of the first side wall 13a. Further, by inserting the second side wall 13b into the second recess 33b, the movement of the first member 31 is restrained in the direction intersecting the extending direction of the second side wall 13b. As a result, in the state where the first member 31 is connected to the mounting portion 18, the movement in the surface direction of the placement surface 12 and the movement in the rotation direction about the direction intersecting the surface direction of the placement surface 12 are restrained. Is done.
 図4、図7に示すように、第2部材35は、第1部材31の筒体32の外径と略同等かあるいは若干大きい内径である略円筒形状の第1の筒体36と、第2部材35が装着部18に接続された状態において第1の筒体36よりも装着部18に近い側に配置されるとともに、第1の筒体36の外径よりも大きな外径を備える略円筒形状の第2の筒体37と、第1の筒体36と第2の筒体37とを接続する接続部38と、第1の筒体36および第2の筒体37に対して穿刺針20の突出方向Zを軸にした回転力を付与するツマミ部39と、を有する。ツマミ部39に対して回転力を付与することによって、第2部材35の第1の筒体36の内周面が第1部材31の筒体32の外周面32aにガイドされた状態において、第2部材35は第1部材31に対して相対的に回転する。 As shown in FIGS. 4 and 7, the second member 35 includes a first cylindrical body 36 having a substantially cylindrical shape having an inner diameter substantially equal to or slightly larger than the outer diameter of the cylindrical body 32 of the first member 31. In a state where the two members 35 are connected to the mounting portion 18, the second member 35 is disposed closer to the mounting portion 18 than the first cylindrical body 36, and has an outer diameter larger than the outer diameter of the first cylindrical body 36. Puncture with respect to the first cylindrical body 36 and the second cylindrical body 37, the cylindrical second cylindrical body 37, the connecting portion 38 that connects the first cylindrical body 36 and the second cylindrical body 37, And a knob 39 for applying a rotational force with the protruding direction Z of the needle 20 as an axis. In the state where the inner peripheral surface of the first cylindrical body 36 of the second member 35 is guided by the outer peripheral surface 32 a of the cylindrical body 32 of the first member 31 by applying a rotational force to the knob portion 39, The two members 35 rotate relative to the first member 31.
 図7、図8を参照して、第2の筒体37には、第2部材35の回転に応じて装着部18の第1開口部13a1への挿入と離脱が行われる第1のロック爪37aと、第2部材35の回転に応じて装着部18の第2開口部13b1への挿入と離脱が行われる第2のロック爪37bと、を有する。第1のロック爪37aおよび第2のロック爪37bは、第2の筒体37の外周面37cに沿って延びる円弧形状を備える。装着部18の第1開口部13a1および第2開口部13b1に第1のロック爪37aおよび第2のロック爪37bをそれぞれ挿入・離脱させることによって、載置面12の面方向に交差する方向における第2部材35の移動の拘束と拘束の解除とを行うことができる。 Referring to FIGS. 7 and 8, the second cylindrical body 37 has a first lock claw that is inserted into and removed from the first opening 13 a 1 of the mounting portion 18 according to the rotation of the second member 35. 37a and a second lock claw 37b in which the mounting portion 18 is inserted into and removed from the second opening 13b1 in accordance with the rotation of the second member 35. The first lock claw 37 a and the second lock claw 37 b have an arc shape extending along the outer peripheral surface 37 c of the second cylinder 37. The first lock claw 37a and the second lock claw 37b are inserted into and removed from the first opening 13a1 and the second opening 13b1 of the mounting portion 18 in the direction intersecting the surface direction of the placement surface 12, respectively. The movement of the second member 35 can be restricted and the restriction can be released.
 次に、穿刺機構110について説明する。 Next, the puncture mechanism 110 will be described.
 図2、図9~図15に示すように、穿刺機構110は、穿刺針20を保持する穿刺針保持部111と、穿刺針20の突出方向Zの付勢力を穿刺針保持部111に付与する付勢部材112と、を備える。 As shown in FIGS. 2 and 9 to 15, the puncture mechanism 110 applies to the puncture needle holding portion 111 a puncture needle holding portion 111 that holds the puncture needle 20 and a biasing force in the protruding direction Z of the puncture needle 20. And an urging member 112.
 穿刺針保持部111は、カニューレ21を保持する第1保持部130および内針22を保持する第2保持部140を有する。穿刺針保持部111は、穿刺針20の突出方向Zにおいて移動可能な状態において筐体30に収容される。 The puncture needle holding unit 111 includes a first holding unit 130 that holds the cannula 21 and a second holding unit 140 that holds the inner needle 22. The puncture needle holding part 111 is accommodated in the housing 30 in a state where it can move in the protruding direction Z of the puncture needle 20.
 図10に示すように、第1保持部130は、カニューレ21の一部を突出させた状態において保持する基部131と、第1保持部130の外部から薬液を供給する送液管222(図29(B)参照)が挿入される内腔132aを備える接続ポート132と、接続ポート132を覆うようにして取り付けられるキャップ133と、基部131においてカニューレ21を保持する側とは異なる側に取り付けられた蓋部材134と、基部131と蓋部材134との間に設けられたシール部材135と、を備えている。 As shown in FIG. 10, the first holding unit 130 includes a base 131 that holds a portion of the cannula 21 in a protruding state, and a liquid supply pipe 222 that supplies a chemical solution from the outside of the first holding unit 130 (FIG. 29). (See (B)) a connection port 132 having a lumen 132a to be inserted, a cap 133 attached so as to cover the connection port 132, and a base 131 attached to a side different from the side holding the cannula 21 A lid member 134 and a seal member 135 provided between the base 131 and the lid member 134 are provided.
 基部131は、第1保持部130の土台となる部位であり、本実施形態においては略円筒形状にて構成している。基部131は、カニューレ21を設置する内部空間131aを備えており、当該内部空間131aはカニューレ21を支持できるように、カニューレ21の形状に合わせて漏斗形状を備えるように構成している。基部131の外周部には、穿刺機構110の第2保持部140のアーム143が係合する凹部136が設けられている。 The base portion 131 is a portion that becomes a base of the first holding portion 130, and is configured in a substantially cylindrical shape in the present embodiment. The base 131 includes an internal space 131 a in which the cannula 21 is installed. The internal space 131 a is configured to have a funnel shape in accordance with the shape of the cannula 21 so that the cannula 21 can be supported. On the outer periphery of the base 131, a recess 136 is provided in which the arm 143 of the second holding unit 140 of the puncture mechanism 110 is engaged.
 接続ポート132は、基部131において、カニューレ21の有する円筒形状の軸と交差する方向に向かって延在している。接続ポート132の内腔132aと基部131の内部空間131aとは連通している。 The connection port 132 extends in the base 131 in a direction intersecting with the cylindrical axis of the cannula 21. The lumen 132a of the connection port 132 and the internal space 131a of the base 131 communicate with each other.
 キャップ133は、次の特性を備えた材料によって形成されていることが好ましい。すなわち、(i)第1保持部130の外部から薬液を供給する送液管222を挿し込むことができること、(ii)挿し込まれた送液管222と接続ポート132との間を液密に保つことができること、(iii)送液管222が挿し込まれることによってキャップ133に形成された穴は、送液管222が抜去された後に塞がること、という特性を備えた材料によって形成されていることが好ましい。そのような特性を備えた材料としては、例えばゴム等が挙げられる。 The cap 133 is preferably formed of a material having the following characteristics. That is, (i) the liquid feeding pipe 222 that supplies the chemical solution from the outside of the first holding unit 130 can be inserted, and (ii) the liquid feeding pipe 222 and the connection port 132 are inserted in a liquid-tight manner. (Iii) The hole formed in the cap 133 by inserting the liquid feeding pipe 222 is formed of a material having the characteristics that it is closed after the liquid feeding pipe 222 is removed. It is preferable. Examples of the material having such characteristics include rubber.
 蓋部材134は、シール部材135を押さえる機能を備えている。蓋部材134には、カニューレ21の軸方向と同軸上に、内針22を挿通可能な貫通穴137が形成されている。 The lid member 134 has a function of pressing the seal member 135. A through hole 137 through which the inner needle 22 can be inserted is formed in the lid member 134 coaxially with the axial direction of the cannula 21.
 シール部材135は、内針22を挿し込むことができるように構成されるとともに、内針22が貫通穴137から抜去された後に貫通穴137からインスリンが漏れ出ることを防止する。シール部材135の材料としては、例えばゴム等が挙げられる。 The seal member 135 is configured so that the inner needle 22 can be inserted, and prevents the insulin from leaking out from the through hole 137 after the inner needle 22 is removed from the through hole 137. Examples of the material of the seal member 135 include rubber.
 図11(A)、図12に示すように、第2保持部140は、内針22を保持する主部材141と、内針22の突出方向Zにおいて主部材141から離間されている板状の副部材142と、第1保持部130を挟持するために副部材142に回転自在に接続される一対のアーム143と、を有する。第2保持部140は、一対のアーム143の各々と主部材141とを接続する一対の連結部材144と、内針22の突出方向Zにおける主部材141と副部材142との間の距離hを所定の大きさに維持するロックアーム145と、をさらに有する。 As shown in FIG. 11A and FIG. 12, the second holding portion 140 has a main member 141 that holds the inner needle 22 and a plate-like shape that is separated from the main member 141 in the protruding direction Z of the inner needle 22. The auxiliary member 142 includes a pair of arms 143 that are rotatably connected to the auxiliary member 142 to sandwich the first holding unit 130. The second holding unit 140 is configured to set a distance h between the pair of connecting members 144 that connect each of the pair of arms 143 and the main member 141 and the main member 141 and the sub member 142 in the protruding direction Z of the inner needle 22. And a lock arm 145 that maintains a predetermined size.
 図12(A)に示すように、主部材141は、板状の基材141aと、内針22を保持する保持部141bと、を有する。保持部141bは、基材141aにおいて副部材142に対向する面とは異なる面から円筒形状を備えて突出している。保持部141bによる内針22の保持方法は特に限定されない。本実施形態では、保持部141bは、保持部141bの内腔141cに内針22を挿通した状態において内針22を保持する。本実施形態において、内腔141cと内針22とは接着剤によって接着される。 As shown in FIG. 12A, the main member 141 has a plate-like base material 141a and a holding portion 141b for holding the inner needle 22. The holding portion 141b protrudes with a cylindrical shape from a surface different from the surface facing the sub member 142 in the base material 141a. The method for holding the inner needle 22 by the holding portion 141b is not particularly limited. In the present embodiment, the holding portion 141b holds the inner needle 22 in a state where the inner needle 22 is inserted into the lumen 141c of the holding portion 141b. In the present embodiment, the lumen 141c and the inner needle 22 are bonded by an adhesive.
 図12(B)に示すように、一対のアーム143の各々は、第1保持部130の凹部136に係合する係合爪143aを備える。係合爪143aは、アーム143において副部材142に接続される接続箇所143bから離間された位置に設けられる。これにより、アーム143と副部材142との接続箇所143bを支点にしてアーム143が回転することによって、一対のアーム143の係合爪143a同士の間の距離dが変化する。その結果、一対のアーム143は、第1保持部130を挟持した状態と第1保持部130の挟持を解除した状態とを切り替えることができる。 12B, each of the pair of arms 143 includes an engaging claw 143a that engages with the recess 136 of the first holding unit 130. The engaging claw 143a is provided at a position separated from the connection portion 143b connected to the sub member 142 in the arm 143. Thereby, the distance d between the engaging claws 143a of the pair of arms 143 changes as the arm 143 rotates with the connection portion 143b between the arm 143 and the sub member 142 as a fulcrum. As a result, the pair of arms 143 can switch between a state in which the first holding unit 130 is held and a state in which the holding of the first holding unit 130 is released.
 連結部材144は、アーム143において係合爪143aが設けられる箇所と副部材142に接続される接続箇所143bとは異なる箇所143cと主部材141とを接続する。これにより、内針22の突出方向Zにおける主部材141と副部材142との間の距離hが変化すると、連結部材144から作用される力によって接続箇所143bを支点にしたトルクがアーム143に加えられる。その結果、接続箇所143bを支点にしてアーム143が回転する。 The connecting member 144 connects the main member 141 with a location 143c different from the location where the engagement claw 143a is provided in the arm 143 and the connection location 143b connected to the sub member 142. As a result, when the distance h between the main member 141 and the sub member 142 in the protruding direction Z of the inner needle 22 changes, a torque applied to the connecting portion 143b as a fulcrum is applied to the arm 143 by the force applied from the connecting member 144. It is done. As a result, the arm 143 rotates with the connection location 143b as a fulcrum.
 図12(A)に示すように、ロックアーム145は、一端145aにおいて副部材142に回転自在に接続されるとともに、他端145bにおいて主部材141に係合する係合爪145cを備える。ロックアーム145の係合爪145cが主部材141に係合することによって、内針22の突出方向Zにおける主部材141と副部材142との間の距離hが所定の大きさに維持される。これにより、アーム143において副部材142に接続される接続箇所143bを支点にしたアーム143の回転が規制される。その結果、アーム143による第1保持部130の挟持の解除が意図しないタイミングで行われることを防止できる。 As shown in FIG. 12 (A), the lock arm 145 includes an engaging claw 145c that is rotatably connected to the sub member 142 at one end 145a and that engages with the main member 141 at the other end 145b. When the engagement claw 145c of the lock arm 145 is engaged with the main member 141, the distance h between the main member 141 and the sub member 142 in the protruding direction Z of the inner needle 22 is maintained at a predetermined size. As a result, the rotation of the arm 143 using the connection portion 143b connected to the sub member 142 in the arm 143 as a fulcrum is restricted. As a result, it is possible to prevent the holding of the first holding unit 130 by the arm 143 from being performed at an unintended timing.
 図13に示すように、付勢部材112は、筐体30内において、穿刺針保持部111に対して穿刺針20の突出方向Zの付勢力を付与する。 As shown in FIG. 13, the urging member 112 applies an urging force in the protruding direction Z of the puncture needle 20 to the puncture needle holding part 111 in the housing 30.
 図13に示すように、本実施形態において、筐体30の第1部材31の筒体32は、付勢部材112の一の端部112aを支持する支持部32bと、穿刺針20の突出方向Zに交差する方向の付勢部材112の移動を規制する突起部32cと、をさらに備える。 As shown in FIG. 13, in the present embodiment, the cylindrical body 32 of the first member 31 of the housing 30 includes a support portion 32 b that supports one end portion 112 a of the urging member 112 and the protruding direction of the puncture needle 20. And a protrusion 32c that restricts the movement of the urging member 112 in the direction crossing Z.
 図12(B)、図14に示すように、本実施形態において、第2保持部140の連結部材144は、付勢部材112において支持部32bに支持される端部112aとは異なる端部112bを支持する支持部144aを備える。 As shown in FIGS. 12B and 14, in the present embodiment, the connecting member 144 of the second holding portion 140 has an end portion 112 b different from the end portion 112 a supported by the support portion 32 b in the biasing member 112. The support part 144a which supports is provided.
 図13(A)、図14(A)に示すように、付勢部材112は、筐体30側の支持部32bと穿刺針保持部111側の支持部144aとの間において支持される。穿刺針保持部111は穿刺針20の突出方向Zにおいて移動可能な状態において筐体30に収容されているから、筐体30側の支持部32bと穿刺針保持部111側の支持部144aとの間の距離は付勢部材112の自然長よりも短くできる。筐体30側の支持部32bと穿刺針保持部111側の支持部144aとの間の距離が付勢部材112の自然長よりも短くされることによって、筐体30側の支持部32bおよび穿刺針保持部111側の支持部144aにはそれぞれ付勢部材112から付勢力が付与される。 13A and 14A, the urging member 112 is supported between the support part 32b on the housing 30 side and the support part 144a on the puncture needle holding part 111 side. Since the puncture needle holding part 111 is accommodated in the housing 30 in a state where it can move in the protruding direction Z of the puncture needle 20, the support part 32b on the housing 30 side and the support part 144a on the puncture needle holding part 111 side are arranged. The distance between them can be shorter than the natural length of the biasing member 112. The distance between the support portion 32b on the housing 30 side and the support portion 144a on the puncture needle holding portion 111 side is made shorter than the natural length of the biasing member 112, so that the support portion 32b and the puncture needle on the housing 30 side A biasing force is applied from the biasing member 112 to the support portion 144a on the holding portion 111 side.
 上述したように、筐体30が本体部10に接続された状態において、穿刺針20の突出方向Zにおける筐体30の移動は拘束されている。そのため、付勢部材112から筐体30側の支持部32bに付与される付勢力によって筐体30が穿刺針20の突出方向Zに移動することはない。一方で、筐体30に収容された状態において穿刺針保持部111は穿刺針20の突出方向Zにおいて移動可能な状態にある。そのため、付勢部材112から穿刺針保持部111側の支持部144aに付与された付勢力によって穿刺針保持部111は穿刺針20の突出方向Zに向かって移動する。その結果、図13(B)、図14(B)に示すように、穿刺針20は、本体部10の載置面12に形成された挿通穴12aを通過して本体部10から突出する。 As described above, the movement of the casing 30 in the protruding direction Z of the puncture needle 20 is restricted in a state where the casing 30 is connected to the main body 10. Therefore, the housing 30 does not move in the protruding direction Z of the puncture needle 20 due to the urging force applied from the urging member 112 to the support portion 32b on the housing 30 side. On the other hand, the puncture needle holding part 111 is movable in the protruding direction Z of the puncture needle 20 in the state accommodated in the housing 30. Therefore, the puncture needle holding part 111 moves in the protruding direction Z of the puncture needle 20 by the urging force applied from the urging member 112 to the support part 144a on the puncture needle holding part 111 side. As a result, as shown in FIGS. 13B and 14B, the puncture needle 20 passes through the insertion hole 12 a formed in the placement surface 12 of the main body 10 and protrudes from the main body 10.
 図16、図17に示すように、本実施形態において、筐体30の第1部材31の筒体32は、穿刺針20の突出方向Zに沿った穿刺針保持部111の移動をガイドするガイド溝32dをさらに備える。穿刺針保持部111は、第2保持部140のアーム143の側面143d(図11(A)参照)がガイド溝32dの側面32eに対向した状態において筐体30に収容される。穿刺針保持部111は、第2保持部140のアーム143の側面143dがガイド溝32dの側面32eにガイドされながら、付勢部材112によって付与される付勢力によって穿刺針20の突出方向Zに移動する。 As shown in FIGS. 16 and 17, in this embodiment, the cylindrical body 32 of the first member 31 of the housing 30 guides the movement of the puncture needle holding unit 111 along the protruding direction Z of the puncture needle 20. A groove 32d is further provided. The puncture needle holding part 111 is accommodated in the housing 30 in a state where the side surface 143d (see FIG. 11A) of the arm 143 of the second holding part 140 faces the side surface 32e of the guide groove 32d. The puncture needle holding unit 111 moves in the protruding direction Z of the puncture needle 20 by the urging force applied by the urging member 112 while the side surface 143d of the arm 143 of the second holding unit 140 is guided by the side surface 32e of the guide groove 32d. To do.
 図13、図16に示すように、筐体30の第1部材31の筒体32は、第2保持部140の一対のロックアーム145の各々に当接することによって、一対のロックアーム145の各々が第2保持部140の主部材141に係合した状態とするロック壁32fを備える。ロック壁32fは、穿刺針20が本体部10から突出する前の状態(例えば、図13(A)に示す状態)において一対のロックアーム145の各々に当接する。そして、穿刺針20が本体部10から突出した状態(例えば、図13(B)に示す状態)において、一対のロックアーム145の各々とロック壁32fとの当接は解除される。 As shown in FIGS. 13 and 16, the cylindrical body 32 of the first member 31 of the housing 30 abuts on each of the pair of lock arms 145 of the second holding unit 140, thereby each of the pair of lock arms 145. Includes a lock wall 32f that is engaged with the main member 141 of the second holding part 140. The lock wall 32f contacts each of the pair of lock arms 145 in a state before the puncture needle 20 protrudes from the main body 10 (for example, the state shown in FIG. 13A). When the puncture needle 20 protrudes from the main body 10 (for example, the state shown in FIG. 13B), the contact between each of the pair of lock arms 145 and the lock wall 32f is released.
 筐体30の第1部材31の筒体32がロック壁32fを備えることによって、穿刺針20が突出する前の状態において一対のロックアーム145の各々が第2保持部140の主部材141に係合した状態が維持される。これにより、穿刺針20が突出する前の状態において第2保持部140のアーム143が第1保持部130を挟持した状態が維持される。 Since the cylindrical body 32 of the first member 31 of the housing 30 includes the lock wall 32f, each of the pair of lock arms 145 is engaged with the main member 141 of the second holding unit 140 before the puncture needle 20 protrudes. The combined state is maintained. Thereby, the state in which the arm 143 of the second holding unit 140 sandwiches the first holding unit 130 in the state before the puncture needle 20 protrudes is maintained.
 一方で、ロック壁32fは、本体部10から穿刺針20が突出した状態において一対のロックアーム145の各々に当接した状態を解除する。これにより、第2保持部140の一対のロックアーム145の各々が第2保持部140の主部材141に係合した状態が解除されるから、内針22の突出方向Zにおける主部材141と副部材142との間の距離hが所定の大きさよりも大きくなる。そのため、第2保持部140のアーム143が第1保持部130を挟持した状態が解除される。その結果、図15に示すように、第1保持部130を本体部10に残した状態において筐体30を本体部10から分離させることができる。 On the other hand, the lock wall 32f cancels the state where it abuts on each of the pair of lock arms 145 in a state where the puncture needle 20 protrudes from the main body portion 10. As a result, the state in which each of the pair of lock arms 145 of the second holding part 140 is engaged with the main member 141 of the second holding part 140 is released, so that the main member 141 and the auxiliary member in the protruding direction Z of the inner needle 22 are released. The distance h between the member 142 is larger than a predetermined size. Therefore, the state where the arm 143 of the second holding unit 140 holds the first holding unit 130 is released. As a result, as shown in FIG. 15, the housing 30 can be separated from the main body 10 in a state where the first holding portion 130 remains in the main body 10.
 図9を再び参照して、穿刺機構110は、付勢部材112が付与する付勢力に抗して穿刺針保持部111の移動を規制する規制部113をさらに備える。そして、規制部113による規制は、穿刺針20の突出方向Zを軸に筐体30が本体部10に対して相対的に回転する動作に連動して解除される。 Referring to FIG. 9 again, the puncture mechanism 110 further includes a restricting portion 113 that restricts the movement of the puncture needle holding portion 111 against the biasing force applied by the biasing member 112. Then, the restriction by the restriction portion 113 is released in conjunction with an operation in which the housing 30 rotates relative to the main body portion 10 about the protruding direction Z of the puncture needle 20.
 規制部113は、付勢部材112が付与する付勢力に抗して穿刺針20が突出していない状態に維持する第1規制部113aと、付勢部材112が付与する付勢力に抗して穿刺針20の突出量を所定の大きさに維持する第2規制部113bと、を有する。 The restricting portion 113 is punctured against the first restricting portion 113a that maintains the state where the puncture needle 20 does not protrude against the biasing force applied by the biasing member 112 and the biasing force that the biasing member 112 applies. And a second restricting portion 113b for maintaining the protruding amount of the needle 20 at a predetermined size.
 図11(A)、図11(C)に示すように、第2保持部140の主部材141は、主部材141において副部材142に対向する面とは異なる面から突出する支柱141dをさらに有する。第1規制部113aは、内針22の突出方向Zに交差する一の方向に沿って支柱141dの外周面141eから互いに異なる向きに対をなして突出した形状を備える。また、第2規制部113bは、内針22の突出方向Zと第1規制部113aの突出方向とに交差する方向に沿って支柱141dの外周面141eから互いに異なる向きに対をなして突出した形状を備える。第2規制部113bは、支柱141dの外周面141eにおいて、穿刺針20の突出方向Zとは異なる方向に向けて第1規制部113aから離間して形成されている。 As shown in FIGS. 11A and 11C, the main member 141 of the second holding unit 140 further includes a column 141d that protrudes from a surface different from the surface of the main member 141 that faces the sub member 142. . The 1st control part 113a is equipped with the shape protruded in a mutually different direction from the outer peripheral surface 141e of the support | pillar 141d along one direction which cross | intersects the protrusion direction Z of the inner needle 22. As shown in FIG. Further, the second restricting portion 113b protrudes in pairs in different directions from the outer peripheral surface 141e of the support post 141d along the direction intersecting the protruding direction Z of the inner needle 22 and the protruding direction of the first restricting portion 113a. It has a shape. The second restricting portion 113b is formed away from the first restricting portion 113a in a direction different from the protruding direction Z of the puncture needle 20 on the outer peripheral surface 141e of the support post 141d.
 一方、図18に示すように、筐体30の第2部材35のツマミ部39の頂部には、穿刺針20の突出方向Zに窪んでいる凹部39aが形成されている。そして、凹部39aは、第1規制部113aおよび第2規制部113bに当接することによって、穿刺針20の突出方向Zにおける第1規制部113aおよび第2規制部113bの移動を規制する規制面39bを凹部39aの底部に備える。 On the other hand, as shown in FIG. 18, a concave portion 39 a that is recessed in the protruding direction Z of the puncture needle 20 is formed at the top of the knob portion 39 of the second member 35 of the housing 30. And the recessed part 39a contacts the 1st control part 113a and the 2nd control part 113b, and the control surface 39b which controls the movement of the 1st control part 113a and the 2nd control part 113b in the protrusion direction Z of the puncture needle 20 At the bottom of the recess 39a.
 規制面39bには、第1規制部113aが移動可能に構成される鍵穴39cが形成されている。穿刺針保持部111を収容した状態の筐体30を穿刺針20の突出方向Zから平面視した際に、第1規制部113aの輪郭および第2規制部113bの輪郭と鍵穴39cの輪郭とは略同一の形状を備える。 The keyhole 39c comprised so that the 1st control part 113a can move is formed in the control surface 39b. When the housing 30 in a state in which the puncture needle holding unit 111 is accommodated is viewed in plan view from the protruding direction Z of the puncture needle 20, the outline of the first restriction part 113a, the outline of the second restriction part 113b, and the outline of the key hole 39c It has substantially the same shape.
 図19(A)に示すように、穿刺針20が突出していない状態において、第1規制部113aは規制面39bに当接した状態にある。このとき、規制面39bに形成された鍵穴39cの位置と第1規制部113aの位置とはずれた状態にある。これにより、付勢部材112によって付勢力を付与された穿刺針保持部111が穿刺針20の突出方向Zに移動することが規制される。 As shown in FIG. 19A, the first restricting portion 113a is in contact with the restricting surface 39b when the puncture needle 20 is not protruding. At this time, the position of the key hole 39c formed in the restricting surface 39b is shifted from the position of the first restricting portion 113a. As a result, the puncture needle holder 111 applied with the urging force by the urging member 112 is restricted from moving in the protruding direction Z of the puncture needle 20.
 図19(B)に示すように、穿刺針20が突出していない状態において筐体30の第2部材35が第1部材31に対して相対的に回転されると、規制面39bに形成された鍵穴39cの位置と第1規制部113aの位置とが一致する。これにより、第1規制部113aは鍵穴39cを通過して、穿刺針20の突出方向Zに移動可能になる。その結果、穿刺針保持部111が穿刺針20の突出方向Zに移動して本体部10から穿刺針20が突出する(図13(B)、図14(B)参照)。 As shown in FIG. 19B, when the second member 35 of the housing 30 is rotated relative to the first member 31 in a state where the puncture needle 20 does not protrude, the restriction surface 39b is formed. The position of the key hole 39c matches the position of the first restricting portion 113a. Thereby, the 1st control part 113a can move to the protrusion direction Z of the puncture needle 20 through the keyhole 39c. As a result, the puncture needle holding portion 111 moves in the protruding direction Z of the puncture needle 20 and the puncture needle 20 protrudes from the main body portion 10 (see FIGS. 13B and 14B).
 図19(C)に示すように、穿刺針20が突出した状態において第2規制部113bは規制面39bに当接する。このとき、第2規制部113bの突出方向は第1規制部113aの突出方向に交差しているから、第2規制部113bの位置と鍵穴39cの位置とはずれた状態にある。そのため、穿刺針20が突出した状態において第2規制部113bは鍵穴39cを通過しない。これにより、穿刺針20が突出した状態において、付勢部材112によって付勢力を付与された穿刺針保持部111が穿刺針20の突出方向Zに移動することが規制される。その結果、穿刺針20が必要以上に突出することを防止できる。 As shown in FIG. 19C, the second restricting portion 113b contacts the restricting surface 39b in a state where the puncture needle 20 protrudes. At this time, since the protruding direction of the second restricting portion 113b intersects the protruding direction of the first restricting portion 113a, the position of the second restricting portion 113b is shifted from the position of the key hole 39c. Therefore, the second restricting portion 113b does not pass through the keyhole 39c when the puncture needle 20 protrudes. Thereby, in the state where the puncture needle 20 protrudes, the puncture needle holding part 111 to which the urging force is applied by the urging member 112 is restricted from moving in the protruding direction Z of the puncture needle 20. As a result, the puncture needle 20 can be prevented from protruding more than necessary.
 次に、カニューレ21を本体部10に固定する固定機構120について説明する。 Next, the fixing mechanism 120 that fixes the cannula 21 to the main body 10 will be described.
 図20(C)、図21に示すように、固定機構120は、第1保持部130が本体部10に対して突出方向Zとは異なる方向に相対的に移動する動作に伴って当該第1保持部130を当該本体部10に係合する係合部150を備える。係合部150は、第1保持部130側に設けられる第1係合部151と、本体部10側に設けられ、第1係合部151に係合する第2係合部152と、を備える。 As shown in FIG. 20C and FIG. 21, the fixing mechanism 120 includes the first holding unit 130 in accordance with the movement of the first holding unit 130 relative to the main body unit 10 in a direction different from the protruding direction Z. An engaging portion 150 that engages the holding portion 130 with the main body portion 10 is provided. The engaging part 150 includes a first engaging part 151 provided on the first holding part 130 side and a second engaging part 152 provided on the main body part 10 side and engaged with the first engaging part 151. Prepare.
 本実施形態において、第1係合部151は、穿刺針20の突出方向Zに交差する方向に沿って第1保持部130の基部131の外周面から互いに異なる向きに対をなして突出して設けられる。第1係合部151は、第1保持部130の基部131の外周面から突出する基台151aと、基部131の外周面に沿って基台151aから突出して設けられる係合爪151bと、を有する。第2係合部152は、穿刺針20の突出方向Zとは反対の方向に向かって載置面12から突出する基台152aと、穿刺針20の突出方向Zに交差する方向に向かって基台152aの頂部側において基台152aから突出し、穿刺針20が突出した状態において第1保持部130の第1係合部151の係合爪151bと係合する係合爪152bと、を有する。 In the present embodiment, the first engaging portions 151 are provided so as to protrude from the outer peripheral surface of the base 131 of the first holding portion 130 in different directions along the direction intersecting the protruding direction Z of the puncture needle 20. It is done. The first engaging portion 151 includes a base 151 a that protrudes from the outer peripheral surface of the base portion 131 of the first holding portion 130, and an engaging claw 151 b that is provided to protrude from the base 151 a along the outer peripheral surface of the base portion 131. Have. The second engagement portion 152 includes a base 152 a that protrudes from the placement surface 12 in a direction opposite to the protruding direction Z of the puncture needle 20, and a base that extends in a direction that intersects the protruding direction Z of the puncture needle 20. It has an engaging claw 152b that protrudes from the base 152a on the top side of the base 152a and engages with the engaging claw 151b of the first engaging part 151 of the first holding part 130 in a state where the puncture needle 20 protrudes.
 本実施形態において、第1保持部130と本体部10とは、穿刺針20の突出方向Zを軸に第1保持部130が本体部10に対して相対的に回転することによって係合する。 In the present embodiment, the first holding part 130 and the main body part 10 are engaged by rotating the first holding part 130 relative to the main body part 10 about the protruding direction Z of the puncture needle 20.
 具体的には、第1保持部130と本体部10とは、穿刺針20の突出方向Zを軸に筐体30が本体部10に対して相対的に回転する動作に連動して第1保持部130が本体部10に対して相対的に回転することによって係合する。 Specifically, the first holding part 130 and the main body part 10 are first held in conjunction with an operation in which the housing 30 rotates relative to the main body part 10 about the protruding direction Z of the puncture needle 20. The part 130 is engaged by rotating relative to the main body part 10.
 本実施形態では、図18、図19(C)に示すように、筐体30の第2部材35の凹部39aには、穿刺針保持部111の第2保持部140に形成された第2規制部113bを押圧することによって、第2保持部140に対して穿刺針20の突出方向Zを軸にした回転力を作用させる突起39dが設けられている。 In the present embodiment, as shown in FIGS. 18 and 19C, the second restriction formed in the second holding portion 140 of the puncture needle holding portion 111 is formed in the concave portion 39 a of the second member 35 of the housing 30. By pressing the portion 113b, a protrusion 39d is provided that applies a rotational force about the protruding direction Z of the puncture needle 20 to the second holding portion 140.
 また、図14(B)に示すように、筐体30の第1部材31に形成されているガイド溝32dは、穿刺針20が突出した状態において穿刺針保持部111の第2保持部140のアーム143に対向する位置には設けられていない。これにより、穿刺針20が突出した状態において穿刺針20の突出方向Zを軸に穿刺針保持部111は筐体30内において回転可能な状態となる。 As shown in FIG. 14B, the guide groove 32d formed in the first member 31 of the housing 30 is formed on the second holding portion 140 of the puncture needle holding portion 111 in a state where the puncture needle 20 protrudes. It is not provided at a position facing the arm 143. As a result, the puncture needle holding portion 111 is rotatable in the housing 30 around the protruding direction Z of the puncture needle 20 when the puncture needle 20 is projected.
 第2部材35が突起39dを有することにより、穿刺針20が突出した状態において第2部材35を第1部材31に対して相対的に回転させる動作に伴って第2保持部140が回転される。その結果、図20(C)に示すように、第2保持部140に保持された第1保持部130も回転されて、第1保持部130側に設けられる第1係合部151の係合爪151bと、本体部10側に設けられる第2係合部152の係合爪152bと、が係合される。 Since the second member 35 has the protrusion 39d, the second holding unit 140 is rotated in accordance with the operation of rotating the second member 35 relative to the first member 31 in a state where the puncture needle 20 protrudes. . As a result, as shown in FIG. 20C, the first holding portion 130 held by the second holding portion 140 is also rotated, and the first engaging portion 151 provided on the first holding portion 130 side is engaged. The claw 151b and the engagement claw 152b of the second engagement portion 152 provided on the main body 10 side are engaged.
 第1保持部130が本体部10に対して突出方向Zとは異なる方向に相対的に移動する動作に伴って当該第1保持部130を当該本体部10に係合する係合部150を固定機構120が備えることによって次のことが可能になる。すなわち、穿刺針20を本体部10から突出させる動作と第1保持部130を本体部10に固定する動作とを独立して行うことができるから、穿刺針20を本体部10から突出させる動作において穿刺針保持部111が係合部150から力を受けることを回避できる。そして、付勢部材112によって穿刺針保持部111に付与される付勢力とは別に、第1保持部130を本体部10に係合させる力を第1保持部130に独立して付与できる。そのため、本体部10から穿刺針20が突出した状態において、穿刺針20を保持する第1保持部130を本体部10に確実に固定できる。 As the first holding part 130 moves relative to the main body part 10 in a direction different from the protruding direction Z, the engaging part 150 that engages the first holding part 130 with the main body part 10 is fixed. The mechanism 120 includes the following. That is, since the operation of projecting the puncture needle 20 from the main body 10 and the operation of fixing the first holding unit 130 to the main body 10 can be performed independently, the operation of projecting the puncture needle 20 from the main body 10 is possible. It is possible to avoid the puncture needle holding part 111 from receiving a force from the engaging part 150. In addition to the urging force applied to the puncture needle holding unit 111 by the urging member 112, a force for engaging the first holding unit 130 with the main body unit 10 can be independently applied to the first holding unit 130. Therefore, the first holding part 130 that holds the puncture needle 20 can be reliably fixed to the main body part 10 in a state where the puncture needle 20 protrudes from the main body part 10.
 本実施形態において筐体30と本体部10との接続は、係合部150において本体10部と第1保持部130とが係合した状態において穿刺針20の突出方向Zを軸に筐体30が本体部10に対して相対的に回転することによって解除される。 In this embodiment, the housing 30 and the main body 10 are connected to each other with the engaging portion 150 engaged with the main body 10 and the first holding portion 130 with the protruding direction Z of the puncture needle 20 as an axis. Is released by rotating relative to the main body 10.
 図7、図8を参照して、筐体30の第2部材35の第1のロック爪37aおよび第2のロック爪37bは、係合部150において本体部10と第1保持部130とが係合した状態において第2部材35が本体部10に対して相対的に回転することによって本体部10の側壁13の第1開口部13a1および第2開口部13b1から離脱するように所定の長さを備えて形成されている。 Referring to FIGS. 7 and 8, the first lock claw 37 a and the second lock claw 37 b of the second member 35 of the housing 30 are configured so that the main body 10 and the first holding part 130 are engaged with each other in the engaging part 150. When the second member 35 rotates relative to the main body 10 in the engaged state, the second member 35 has a predetermined length so as to be separated from the first opening 13a1 and the second opening 13b1 of the side wall 13 of the main body 10. It is formed with.
 第1のロック爪37aおよび第2のロック爪37bが所定の長さを備えていることにより、筐体30と本体部10との接続は、係合部150において本体部10と第1保持部130とが係合した状態において筐体30が本体部10に対して相対的に回転することによって解除される。これにより、本体部10に対して筐体30を相対的に回転させるという簡便な一回の操作によって、本体部10への第1保持部130の固定と筐体30および本体部10の接続の解除とを連続して行うことができる。 Since the first lock claw 37 a and the second lock claw 37 b have a predetermined length, the connection between the housing 30 and the main body 10 is established in the engagement portion 150 between the main body 10 and the first holding portion. The housing 30 is released by rotating relative to the main body 10 in a state in which the housing 130 is engaged. As a result, the first holding part 130 can be fixed to the main body part 10 and the housing 30 and the main body part 10 can be connected to each other by a simple single operation of rotating the housing 30 relative to the main body part 10. Release can be performed continuously.
 また、別の観点から説明すれば、第1のロック爪37aおよび第2のロック爪37bは、係合部150において本体部10と第1保持部130とが係合されるまでの間において第1のロック爪37aおよび第2のロック爪37bが第1開口部13a1および第2開口部13b1に挿入された状態を維持する長さを備える。これにより、係合部150において本体部10と第1保持部130とが係合する前に筐体30と本体部10との接続が解除されることを防止できる。 Further, from another viewpoint, the first lock claw 37 a and the second lock claw 37 b are not changed until the main body portion 10 and the first holding portion 130 are engaged in the engagement portion 150. The first lock claw 37a and the second lock claw 37b have a length that maintains the state in which they are inserted into the first opening 13a1 and the second opening 13b1. Thereby, it is possible to prevent the connection between the housing 30 and the main body 10 before the main body 10 and the first holding part 130 are engaged in the engaging part 150.
 次に、セーフティキャップ40について説明する。 Next, the safety cap 40 will be described.
 図22、図23を参照して、セーフティキャップ40は、筐体30に接続・分離可能に構成されるとともに、筐体30に接続された状態において本体部10に対する筐体30の回転を規制する。セーフティキャップ40は、第2部材35のツマミ部39の凹部39aの壁面39e(図18参照)と穿刺針保持部111の第2保持部140の第2規制部113bとの間に挿入される突起40aを備える。 Referring to FIGS. 22 and 23, safety cap 40 is configured to be connectable / separable to housing 30 and restricts rotation of housing 30 with respect to main body 10 in a state of being connected to housing 30. . The safety cap 40 is a protrusion inserted between the wall surface 39e (see FIG. 18) of the concave portion 39a of the knob portion 39 of the second member 35 and the second restricting portion 113b of the second holding portion 140 of the puncture needle holding portion 111. 40a.
 第2部材35の凹部39aの壁面39eと穿刺針保持部111の第2保持部140の第2規制部113bとの間に突起40aが挿入されることによって第2部材35の第1部材31に対する回転が規制される。これにより、意図しないタイミングで筐体30が本体部10に対して相対的に回転することを防止できる。 The protrusion 40a is inserted between the wall surface 39e of the concave portion 39a of the second member 35 and the second restricting portion 113b of the second holding portion 140 of the puncture needle holding portion 111, whereby the second member 35 with respect to the first member 31 is inserted. Rotation is regulated. Thereby, it can prevent that the housing | casing 30 rotates relatively with respect to the main-body part 10 at the timing which is not intended.
 図24を参照して、セーフティキャップ40は、筐体30が本体部10から分離された後にカニューレ21から抜去された内針22を覆った状態で当該筐体30に取り付け可能に構成される。セーフティキャップ40は、筐体30の第1部材31に係合する係合爪40bを備える。図4を参照して、筐体30の第1部材31の脚部33には、セーフティキャップ40の係合爪40bが係合する開口部33cが設けられる。図24を参照して、セーフティキャップ40の係合爪40bが開口部33cに係合することによって筐体30にセーフティキャップ40が取り付けられる。 Referring to FIG. 24, the safety cap 40 is configured to be attachable to the housing 30 in a state where the inner needle 22 removed from the cannula 21 is covered after the housing 30 is separated from the main body portion 10. The safety cap 40 includes an engaging claw 40 b that engages with the first member 31 of the housing 30. Referring to FIG. 4, an opening 33 c that engages with an engaging claw 40 b of the safety cap 40 is provided in the leg portion 33 of the first member 31 of the housing 30. Referring to FIG. 24, the safety cap 40 is attached to the housing 30 by the engagement claw 40 b of the safety cap 40 engaging with the opening 33 c.
 次に、図25~29を主に参照して、穿刺装置100の使用例について説明する。 Next, a usage example of the puncture apparatus 100 will be described mainly with reference to FIGS.
 まず、生体において穿刺装置100を使用してカニューレ21を留置したい所望の箇所に本体部10の付着部16を付着させる。 First, using the puncture device 100 in the living body, the attachment portion 16 of the main body portion 10 is attached to a desired location where the cannula 21 is to be placed.
 次に、筐体30に取り付けられているセーフティキャップ40を取り外す。これにより、筐体30の第2部材35は第1部材31に対して回転可能になる。 Next, the safety cap 40 attached to the housing 30 is removed. Thereby, the second member 35 of the housing 30 can be rotated with respect to the first member 31.
 次に、図25(A)に示すように、第2部材35の第1のロック爪37aおよび第2のロック爪37bが装着部18の第1開口部13a1および第2開口部13b1から離脱する方向(図8(A)参照)に向かって、ツマミ部39を使用して第1部材31に対して第2部材35を相対的に回転させる。第1部材31に対する第2部材35の相対的な回転は、第2部材35の凹部39aに形成されている鍵穴39cの位置と穿刺針保持部111の第2保持部140の支柱141dに形成されている第1規制部113aの位置とが一致するまで行う(図19(B)参照)。鍵穴39cの位置と第1規制部113aの位置とが一致することによって穿刺針20の突出方向Zにおける穿刺針保持部111の移動の規制が解除されて穿刺針20が本体部10から突出する(図13(B)、図14(B)参照)。 Next, as shown in FIG. 25A, the first lock claw 37a and the second lock claw 37b of the second member 35 are disengaged from the first opening 13a1 and the second opening 13b1 of the mounting portion 18. The second member 35 is rotated relative to the first member 31 using the knob 39 in the direction (see FIG. 8A). The relative rotation of the second member 35 with respect to the first member 31 is formed in the position of the key hole 39c formed in the concave portion 39a of the second member 35 and the column 141d of the second holding portion 140 of the puncture needle holding portion 111. This is performed until the position of the first restricting portion 113a matches (see FIG. 19B). When the position of the key hole 39c matches the position of the first restricting portion 113a, the restriction of movement of the puncture needle holding portion 111 in the protruding direction Z of the puncture needle 20 is released, and the puncture needle 20 protrudes from the main body portion 10 ( (See FIGS. 13B and 14B).
 次に、図25(B)に示すように、第2部材35の第1のロック爪37aおよび第2のロック爪37bが第1開口部13a1および第2開口部13b1から離脱する方向に向かって、第1部材31に対して第2部材35を相対的にさらに回転させる。このとき、第2部材35の凹部39aに形成されている突起39dによって穿刺針保持部111の第2保持部140の支柱141dに形成されている第2規制部113bが押圧される(図19(C)参照)。これにより、穿刺針20の突出方向Zを軸にして穿刺針保持部111が回転される。 Next, as shown in FIG. 25 (B), the first lock claw 37a and the second lock claw 37b of the second member 35 are moved away from the first opening 13a1 and the second opening 13b1. The second member 35 is further rotated relative to the first member 31. At this time, the second restricting portion 113b formed on the support post 141d of the second holding portion 140 of the puncture needle holding portion 111 is pressed by the protrusion 39d formed on the concave portion 39a of the second member 35 (FIG. 19 ( C)). Thereby, the puncture needle holding part 111 is rotated around the protruding direction Z of the puncture needle 20.
 次に、穿刺針20の突出方向Zを軸にして穿刺針保持部111を回転させる動作に伴って、穿刺針保持部111の第1保持部130の第1係合部151と本体部10の第2係合部152とを係合させる(図20(C)参照)。これにより、第1保持部130が本体部10に固定される。第1保持部130が本体部10に固定されることによって、第1保持部130に保持された状態においてカニューレ21が生体に確実に留置される。 Next, in accordance with the operation of rotating the puncture needle holding unit 111 about the protruding direction Z of the puncture needle 20, the first engagement portion 151 of the first holding unit 130 of the puncture needle holding unit 111 and the main body unit 10 are rotated. The second engaging portion 152 is engaged (see FIG. 20C). Thereby, the first holding part 130 is fixed to the main body part 10. By fixing the first holding unit 130 to the main body unit 10, the cannula 21 is reliably placed in the living body while being held by the first holding unit 130.
 次に、図26(A)を参照して、第1のロック爪37aおよび第2のロック爪37bが第1開口部13a1および第2開口部13b1から離脱する方向に向かって、第1部材31に対して第2部材35を相対的にさらに回転させる。そして、第1開口部13a1および第2開口部13b1から第1のロック爪37aおよび第2のロック爪37bを離脱させる。これにより、載置面12の面方向に交差する方向における第2部材35の移動の拘束が解除される。 Next, referring to FIG. 26 (A), the first member 31 moves in the direction in which the first lock claw 37a and the second lock claw 37b are detached from the first opening 13a1 and the second opening 13b1. In contrast, the second member 35 is further rotated relatively. Then, the first lock claw 37a and the second lock claw 37b are detached from the first opening 13a1 and the second opening 13b1. Thereby, the restriction | limiting of the movement of the 2nd member 35 in the direction which cross | intersects the surface direction of the mounting surface 12 is cancelled | released.
 次に、図26(B)を参照して、穿刺針20の突出方向Zとは反対の方向に筐体30を引き上げることによって本体部10と筐体30との接続を解除する。 Next, referring to FIG. 26 (B), the connection between the main body 10 and the housing 30 is released by pulling up the housing 30 in the direction opposite to the protruding direction Z of the puncture needle 20.
 次に、筐体30から取り外したセーフティキャップ40を筐体30に取り付ける。具体的には、セーフティキャップ40に形成されている係合爪40bを筐体30の第1部材31の脚部33に形成されている開口部33cに係合させることによってセーフティキャップ40を筐体30に取り付ける(図4、図24(B)参照)。これにより、筐体30が本体部10から分離された後の穿刺針20による誤穿刺を防止できる。 Next, the safety cap 40 removed from the housing 30 is attached to the housing 30. Specifically, by engaging the engaging claw 40b formed on the safety cap 40 with the opening 33c formed on the leg portion 33 of the first member 31 of the housing 30, the safety cap 40 is mounted on the housing. 30 (see FIGS. 4 and 24B). Thereby, the erroneous puncture by the puncture needle 20 after the housing | casing 30 is isolate | separated from the main-body part 10 can be prevented.
 以上の操作によって、穿刺装置100を使用したカニューレ21の生体への留置が完了する。 By the above operation, placement of the cannula 21 in the living body using the puncture device 100 is completed.
 次に、図27に示すように、本体部10から筐体30を取り外した後、本体部10に送出機構200を装着させる。 Next, as shown in FIG. 27, after removing the housing 30 from the main body 10, the sending mechanism 200 is attached to the main body 10.
 前述したように、本体部10から筐体30を取り外した後は、第1保持部130が本体部10に残される。所定の投与物を投与するための送出機構200を第1保持部130に接続させることで、第1保持部130の接続ポート132の内腔132aおよび基部131の内部空間131aを介してカニューレ21内へ投与物を送り込むことができる。その結果、基部131の内部空間131aに保持されたカニューレ21を介して投与物を生体内へ送出させることが可能になる。 As described above, after removing the housing 30 from the main body 10, the first holding part 130 is left in the main body 10. By connecting the delivery mechanism 200 for administering a predetermined dose to the first holding unit 130, the inside of the cannula 21 is connected via the inner cavity 131 a of the connection port 132 of the first holding unit 130 and the inner space 131 a of the base 131. The dose can be delivered to As a result, the administration product can be delivered into the living body via the cannula 21 held in the internal space 131a of the base 131.
 使用される送出機構200としては、カニューレ21へ所定の投与物を送り込むことが可能に構成されていれば特に制限はないが、例えば、図27および図28に示すように、送液動作に必要な部材を駆動させる駆動力を生じさせる駆動機構211等を含む送液リユース部210およびインスリンが充填された薬液貯蔵部221等を含む送液ディスポ部220と、を有するものが使用される。 The delivery mechanism 200 to be used is not particularly limited as long as a predetermined dose can be fed into the cannula 21, but for example, as shown in FIGS. 27 and 28, it is necessary for the liquid feeding operation. A liquid feeding reuse unit 210 including a driving mechanism 211 that generates a driving force for driving various members and a liquid feeding disposable unit 220 including a drug solution storage unit 221 filled with insulin are used.
 送液リユース部210および送液ディスポ部220は、連結分離可能に構成されている。所定期間の使用後、薬液貯蔵部内のインスリン等を使い切った場合は、送液リユース部210と送液ディスポ部220とを分離し、送液ディスポ部220を使い捨てにして、新しいものに交換することができる。一方、送液リユース部210には、後述するモータ211aやギヤ211bなど、送液ディスポ部220に搭載される構成部材に比べて交換の頻度が少ない比較的高価な構成部材が搭載される。このように所定期間の使用後に廃棄される構成部材と比較的高価な構成部材とを異なるハウジングにそれぞれ搭載させて、比較的高価な構成部材を送液リユース部210に搭載して再利用可能とすることにより、装置の製造コストや使用に伴うコストの低減を図ることを可能にしている。 The liquid feed reuse unit 210 and the liquid feed disposable unit 220 are configured to be connected and separated. When the insulin or the like in the drug solution storage part is used up after a predetermined period of time, the liquid delivery reuse part 210 and the liquid delivery disposable part 220 are separated, and the liquid delivery disposable part 220 is made disposable and replaced with a new one. Can do. On the other hand, the liquid supply reuse unit 210 is mounted with relatively expensive components such as a motor 211a and a gear 211b, which will be described later, which are less expensive to replace than components mounted on the liquid supply disposable unit 220. In this way, a component member discarded after use for a predetermined period and a relatively expensive component member are mounted in different housings, respectively, and the relatively expensive component member is mounted in the liquid feeding reuse unit 210 and can be reused. By doing so, it is possible to reduce the manufacturing cost of the apparatus and the cost associated with use.
 送液リユース部210は、送液動作を行うために必要な部材を駆動させる駆動機構211と、駆動機構211を制御する制御部212と、これらを保持する第1ハウジング213と、を有する。なお、図28において点線Xで囲まれた部分は、送液リユース部210に取り付けられる部品を表し、一点鎖線Yで囲まれた部分は、送液ディスポ部220に取り付けられる部品を表す。なお、図28において、理解の容易のため、第1ハウジング213は省略して示す。 The liquid supply reuse unit 210 includes a drive mechanism 211 that drives members necessary for performing the liquid supply operation, a control unit 212 that controls the drive mechanism 211, and a first housing 213 that holds these. In FIG. 28, a part surrounded by a dotted line X represents a part attached to the liquid feeding reuse part 210, and a part surrounded by a one-dot chain line Y represents a part attached to the liquid feeding disposable part 220. In FIG. 28, the first housing 213 is omitted for easy understanding.
 駆動機構211は、送液ディスポ部220の電池224からの電力によって回転を生じさせる出力軸を備えたモータ211aと、モータ211aによって生じた回転を減速して送液ディスポ部220の押出機構223に伝達する複数のギヤ211bと、を有する。 The drive mechanism 211 includes a motor 211a having an output shaft that generates rotation by the electric power from the battery 224 of the liquid delivery disposable unit 220, and a speed reduction generated by the motor 211a to the extrusion mechanism 223 of the liquid delivery disposable unit 220. A plurality of gears 211b for transmission.
 図28に示すように、送液ディスポ部220は、投与物としての薬液(インスリン等)が充填された薬液貯蔵部221と、第1保持部130の接続ポート132の内腔132aと薬液貯蔵部221とを連通する送液管222と、駆動機構211に機械的に接続されて薬液貯蔵部221内のインスリンを送液管222に押し出す押出機構223と、駆動機構211等に電力を供給する電池224と、これらを保持する第2ハウジング225と、を有している。なお、投与物は、薬液のみに限定されず、生体内への投与を目的としたものであればいずれのものであってもよく、投与時の状態も液体、気体、固体(例えば、粉体、粒状物)、ゲル等のいずれでもよい。 As shown in FIG. 28, the liquid delivery disposable unit 220 includes a drug solution storage unit 221 filled with a drug solution (insulin or the like) as an administration, a lumen 132a of the connection port 132 of the first holding unit 130, and a drug solution storage unit. A liquid supply pipe 222 that communicates with 221; a push mechanism 211 that is mechanically connected to the drive mechanism 211 to push the insulin in the drug solution storage unit 221 to the liquid supply pipe 222; and a battery that supplies power to the drive mechanism 211 and the like 224 and a second housing 225 for holding them. Note that the administration is not limited to a drug solution, and may be any as long as it is intended for administration into a living body, and the administration state may be liquid, gas, solid (for example, powder) , Granular material), gel and the like.
 送液管222は、例えば、鋭利な先端形状を備える金属製の細管により構成している。このように構成される場合、図29(A)に示すように、送出機構200を本体部10に対してスライド移動させながら送出機構200を本体部10に連結させると、図29(B)に示すように、送液管222の鋭利な先端が第1保持部130のキャップ133を貫通し、接続ポート132の内腔132aに送液管222が差し込まれる。すなわち、送出機構200を本体部10に連結する作業を行いつつ、送液管222と接続ポート132とを連結して、薬液を第1保持部130へ送り込むことが可能な状態に組み付け作業を行うことができる。 The liquid feeding tube 222 is constituted by a metal thin tube having a sharp tip shape, for example. In the case of such a configuration, as shown in FIG. 29A, when the delivery mechanism 200 is coupled to the main body 10 while sliding the delivery mechanism 200 relative to the main body 10, the structure shown in FIG. As shown, the sharp tip of the liquid feeding tube 222 passes through the cap 133 of the first holding unit 130, and the liquid feeding tube 222 is inserted into the inner cavity 132 a of the connection port 132. That is, while performing the operation of connecting the delivery mechanism 200 to the main body unit 10, the liquid supply tube 222 and the connection port 132 are connected, and the assembly operation is performed so that the chemical solution can be fed into the first holding unit 130. be able to.
 図28に示すように、押出機構223は、薬液貯蔵部221の内部空間において進退移動可能なスライド部226と、スライド部226に形成された雌ねじと噛合ってスライド部226を進退移動させる送りねじ227と、駆動機構211のギヤ211bと噛合い、送りねじ227に接続されるギヤ228と、を備える。 As shown in FIG. 28, the push-out mechanism 223 includes a slide part 226 that can move forward and backward in the internal space of the chemical solution storage part 221, and a feed screw that meshes with a female screw formed on the slide part 226 to move the slide part 226 forward and backward. 227 and a gear 228 that meshes with the gear 211b of the drive mechanism 211 and is connected to the feed screw 227.
 スライド部226は、スライド部226の側に薬液が漏れ出ないようにシール性を保ちつつ薬液貯蔵部221内を進退移動可能な押出部材226aと、送りねじ227と噛み合う雌ねじが形成された送り板226bと、押出部材226aと送り板226bを連結する連結板226cと、を有している。 The slide part 226 includes a push plate 226a capable of moving forward and backward in the chemical liquid storage part 221 while maintaining a sealing property so that the chemical liquid does not leak to the slide part 226 side, and a feed plate in which a female screw that meshes with the feed screw 227 is formed. 226b and a connecting plate 226c for connecting the push member 226a and the feed plate 226b.
 送液管222と接続ポート132とを連結させた後、駆動機構211のモータ211aを駆動させることによって駆動機構211のギヤ211bおよび押出機構223のギヤ223cを介して送りねじ227が回転する。送りねじ227の回転に伴い、送りねじ227の雄ねじの螺旋形状の軸に沿って送り板226bが移動する。連結板226cを介して送り板226bに連結された押出部材226aは、送り板226bの移動に伴って薬液貯蔵部221内を移動する。押出部材226aが薬液貯蔵部221に押し込まれる方向(収容空間の体積が減少する方向)に移動すると、薬液貯蔵部221と押出部材226aとによって形成された収容空間内の投与物が送液管222に送液される。送液管222に送液されたインスリンは接続ポート132の内腔132a、基部131の内部空間131a、そしてカニューレ21を介して生体(図29において符号Pで図示)に導入される。 After connecting the liquid feeding pipe 222 and the connection port 132, the feed screw 227 is rotated via the gear 211b of the drive mechanism 211 and the gear 223c of the push-out mechanism 223 by driving the motor 211a of the drive mechanism 211. As the feed screw 227 rotates, the feed plate 226b moves along the helical axis of the male screw of the feed screw 227. The pushing member 226a connected to the feed plate 226b through the connecting plate 226c moves in the chemical solution storage unit 221 as the feed plate 226b moves. When the extruding member 226a moves in a direction in which the pusher member 226a is pushed into the medicinal solution storage unit 221 (a direction in which the volume of the containing space decreases), the dose in the containing space formed by the medicinal solution storage unit 221 and the pushing member 226a is transferred to the liquid feeding tube 222. The liquid is sent to Insulin fed to the liquid feeding tube 222 is introduced into the living body (indicated by reference symbol P in FIG. 29) via the inner cavity 132a of the connection port 132, the inner space 131a of the base 131, and the cannula 21.
 このように、筐体30が取り外された穿刺装置100と所定の送出機構200とによって生体内へ投与物を投与する投与装置を構成することができ、この投与装置を使用して投与物の投与を行うことが可能になる。 In this way, the puncture device 100 from which the housing 30 is removed and the predetermined delivery mechanism 200 can constitute an administration device that administers the administration into the living body, and administration of the administration using this administration device. It becomes possible to do.
 以上、本実施形態に係る穿刺装置100は、穿刺針20が本体部10から突出された状態において第1保持部130を本体部10に固定する固定機構120を有する。固定機構120は、第1保持部130を本体部10に係合する係合部150を備える。そして、係合部150は、第1保持部130が本体部10に対して穿刺針20の突出方向Zとは異なる方向に相対的に移動する動作に伴って第1保持部130を本体部10に係合する。これにより、穿刺針20を本体部10から突出させる動作と第1保持部130を本体部10に固定する動作とを独立して行うことができるから、穿刺針20を本体部10から突出させる動作において穿刺針保持部111が係合部150から力を受けることを回避できる。そして、付勢部材112によって穿刺針保持部111に付与される付勢力とは別に、第1保持部130を本体部10に係合させる力を第1保持部130に独立して付与できる。そのため、本体部10から穿刺針20が突出した状態において、穿刺針20を保持する第1保持部130を本体部10に確実に固定できる。従って、生体に対してカニューレを確実に留置できる穿刺装置を提供できる。 As described above, the puncture apparatus 100 according to the present embodiment has the fixing mechanism 120 that fixes the first holding unit 130 to the main body 10 in a state where the puncture needle 20 protrudes from the main body 10. The fixing mechanism 120 includes an engaging portion 150 that engages the first holding portion 130 with the main body portion 10. The engaging portion 150 moves the first holding portion 130 to the main body portion 10 in accordance with an operation in which the first holding portion 130 moves relative to the main body portion 10 in a direction different from the protruding direction Z of the puncture needle 20. Engage with. Thereby, since the operation | movement which protrudes the puncture needle 20 from the main-body part 10 and the operation | movement which fixes the 1st holding | maintenance part 130 to the main-body part 10 can be performed independently, the operation | movement which protrudes the puncture needle 20 from the main-body part 10 In this case, the puncture needle holding part 111 can be prevented from receiving a force from the engaging part 150. In addition to the urging force applied to the puncture needle holding unit 111 by the urging member 112, a force for engaging the first holding unit 130 with the main body unit 10 can be independently applied to the first holding unit 130. Therefore, the first holding part 130 that holds the puncture needle 20 can be reliably fixed to the main body part 10 in a state where the puncture needle 20 protrudes from the main body part 10. Therefore, it is possible to provide a puncture device that can securely place a cannula with respect to a living body.
 また、穿刺装置100によれば、係合部150は、第1保持部130側に設けられる第1係合部151と、本体部10側に設けられ、第1係合部151に係合する第2係合部152と、を備える。これにより、簡便な構成によって第1保持部130を本体部10に係合させることができる。従って、穿刺装置の製造が容易になる。 Further, according to the puncture device 100, the engaging portion 150 is provided on the first holding portion 130 side and the main body portion 10 side, and is engaged with the first engaging portion 151. A second engagement portion 152. Thereby, the 1st holding | maintenance part 130 can be engaged with the main-body part 10 with a simple structure. Therefore, the puncture device can be easily manufactured.
 また、穿刺装置100によれば、係合部150において、第1保持部130と本体部10とは、穿刺針20の突出方向Zを軸に第1保持部130が本体部10に対して相対的に回転することによって係合する。これにより、第1保持部130を回転させるという簡便な操作によって第1保持部130を本体部10に係合させることができる。従って、穿刺装置を使用する際の操作性が向上する。 Further, according to the puncture device 100, in the engaging part 150, the first holding part 130 and the main body part 10 are relative to the main body part 10 about the protruding direction Z of the puncture needle 20. Engaged by rotating in an automatic manner. Thereby, the first holding unit 130 can be engaged with the main body unit 10 by a simple operation of rotating the first holding unit 130. Therefore, the operability when using the puncture device is improved.
 また、穿刺装置100によれば、筐体30は、本体部10に対して相対的に回転することによって本体部10から接続・分離可能に構成される。そして、係合部150において、第1保持部130と本体部10とは、穿刺針20の突出方向Zを軸に筐体30が本体部10に対して相対的に回転する動作に連動して第1保持部130が本体部10に対して相対的に回転することによって係合する。さらに、本体部10と筐体30との接続は、係合部150において第1保持部130と本体部10とが係合した状態において穿刺針20の突出方向Zを軸に筐体30が本体部10に対して相対的に回転することによって解除される。これにより、本体部10に対して筐体30を相対的に回転させるという簡便な一回の操作によって、本体部10への第1保持部130の固定と筐体30および本体部10の接続の解除とを連続して行うことができる。従って、穿刺装置を使用する際の操作性がさらに向上する。 Further, according to the puncture device 100, the housing 30 is configured to be connectable and detachable from the main body 10 by rotating relative to the main body 10. In the engaging portion 150, the first holding portion 130 and the main body portion 10 are interlocked with an operation in which the housing 30 rotates relative to the main body portion 10 about the protruding direction Z of the puncture needle 20. The first holding part 130 is engaged by rotating relative to the main body part 10. Further, the connection between the main body 10 and the housing 30 is such that the housing 30 is the main body about the protruding direction Z of the puncture needle 20 when the first holding portion 130 and the main body 10 are engaged in the engaging portion 150. It is released by rotating relative to the part 10. As a result, the first holding part 130 can be fixed to the main body part 10 and the housing 30 and the main body part 10 can be connected to each other by a simple single operation of rotating the housing 30 relative to the main body part 10. Release can be performed continuously. Therefore, the operability when using the puncture device is further improved.
 また、穿刺装置100によれば、穿刺機構110は、付勢力に抗して穿刺針保持部の移動を規制する規制部113をさらに備える。そして、規制部113による規制は、突出方向Zを軸に筐体30が本体部10に対して相対的に回転する動作に連動して解除される。これにより、筐体30を本体部10に対して相対的に回転させるという簡便な一回の操作によって、生体への穿刺針20の穿刺と、本体部10への第1保持部130の固定と、筐体30および本体部10の接続の解除と、を連続的に行うことができる。従って、穿刺装置を使用する際の操作性がさらに向上する。 Moreover, according to the puncture device 100, the puncture mechanism 110 further includes a restricting portion 113 that restricts the movement of the puncture needle holding portion against the urging force. Then, the restriction by the restriction portion 113 is released in conjunction with an operation in which the housing 30 rotates relative to the main body portion 10 with the protruding direction Z as an axis. Thereby, the puncture of the puncture needle 20 into the living body and the fixing of the first holding unit 130 to the main body 10 by a simple one-time operation of rotating the housing 30 relative to the main body 10. The connection between the casing 30 and the main body 10 can be released continuously. Therefore, the operability when using the puncture device is further improved.
 また、穿刺装置100は、筐体30に接続・分離可能に構成されるとともに、筐体30に接続された状態において本体部10に対する筐体30の回転を規制するセーフティキャップ40をさらに有する。これにより、意図しないタイミングで筐体30が本体部10に対して相対的に回転することを防止できるため穿刺針20の誤発射が防止される。従って、穿刺装置を使用する際の安全性が向上する。 Further, the puncture apparatus 100 is configured to be connectable / separable to the housing 30, and further includes a safety cap 40 that regulates the rotation of the housing 30 relative to the main body 10 when connected to the housing 30. Thereby, since it can prevent that the housing | casing 30 rotates relatively with respect to the main-body part 10 at the timing which is not intended, the erroneous launch of the puncture needle 20 is prevented. Therefore, safety when using the puncture device is improved.
 また、穿刺装置100によれば、セーフティキャップ40は、本体部10から筐体30が分離された後にカニューレ21から抜去された内針22を覆った状態で当該筐体30に取り付け可能に構成される。これにより、本体部10から筐体30が分離された後の穿刺針20による誤穿刺を防止できる。従って、穿刺装置を使用する際の安全性がさらに向上する。 Further, according to the puncture device 100, the safety cap 40 is configured to be attachable to the housing 30 in a state of covering the inner needle 22 removed from the cannula 21 after the housing 30 is separated from the main body portion 10. The Thereby, the erroneous puncture by the puncture needle 20 after the housing | casing 30 is isolate | separated from the main-body part 10 can be prevented. Therefore, the safety when using the puncture device is further improved.
 また、穿刺装置100によれば、本体部10は、生体に貼り付け可能な付着部16と、カニューレ21を介して所定の投与物を生体内へ送出する送出機構200が装着可能な装着部18を有するクレードルと、を備える。これにより、穿刺機構110による穿刺作業を終えた後、穿刺装置100を使用して投与物の投与を行うことが可能となるため、利便性がより一層優れた装置となる。 Moreover, according to the puncture device 100, the main body 10 includes the attachment portion 16 to which the attachment portion 16 that can be attached to a living body and the delivery mechanism 200 that sends a predetermined dose into the living body via the cannula 21 can be attached. A cradle having Thereby, after the puncturing operation by the puncture mechanism 110 is completed, it becomes possible to administer the administration using the puncture device 100, and thus the convenience is further improved.
 以上、本発明に係る穿刺装置を実施形態に基づいて説明したが、本発明に係る穿刺装置は実施形態において説明した構成のみに限定されず、特許請求の範囲の記載に基づいて適宜変更することが可能である。 Although the puncture device according to the present invention has been described based on the embodiment, the puncture device according to the present invention is not limited to the configuration described in the embodiment, and may be appropriately changed based on the description of the scope of claims. Is possible.
 例えば、上述した実施形態において、第1保持部130と本体部10とは、穿刺針20の突出方向Zを軸に第1保持部130が本体部10に対して相対的に回転することによって係合した。しかしながら、第1保持部を本体部に係合する動作は、第1保持部が本体部に対して穿刺針の突出方向とは異なる方向に相対的に移動する動作である限りにおいて限定されない。例えば、係合部は、第1保持部が本体部に対して装着部の載置面の面方向に相対的に移動する動作に伴って第1保持部と本体部とが係合するように構成してもよい。 For example, in the above-described embodiment, the first holding part 130 and the main body part 10 are engaged when the first holding part 130 rotates relative to the main body part 10 about the protruding direction Z of the puncture needle 20. Combined. However, the operation of engaging the first holding portion with the main body is not limited as long as the first holding portion is an operation that moves relative to the main body in a direction different from the protruding direction of the puncture needle. For example, the engaging part is configured so that the first holding part and the main body part engage with the movement of the first holding part relative to the main body part in the surface direction of the mounting surface of the mounting part. It may be configured.
 また、上述した実施形態において、係合部150は、第1保持部130側に設けられる第1係合部151と、本体部10側に設けられ、当該第1係合部151に係合する第2係合部152と、を備えて構成された。しかしながら、係合部の構成は、第1保持部が本体部に対して突出方向とは異なる方向に相対的に移動する動作に伴って当該第1保持部を当該本体部に係合する限りにおいて限定されない。例えば、係合部は、第1保持部側に設けられる第1係合部と、本体部側に設けられる第2係合部と、第1係合部および第2係合部に係合する係合部材と、を備え、第1係合部および第2係合部は、当該係合部材を介して係合するように構成してもよい。 In the above-described embodiment, the engaging portion 150 is provided on the first holding portion 130 side and the main body portion 10 side, and engages with the first engaging portion 151. And a second engaging portion 152. However, the configuration of the engaging portion is as long as the first holding portion engages with the main body portion in accordance with the movement of the first holding portion relative to the main body portion in a direction different from the protruding direction. It is not limited. For example, the engaging portion engages with a first engaging portion provided on the first holding portion side, a second engaging portion provided on the main body portion side, the first engaging portion and the second engaging portion. An engagement member, and the first engagement portion and the second engagement portion may be configured to engage with each other via the engagement member.
 また、穿刺針の突出方向は、本体部からカニューレが突出した状態においてカニューレを本体部に固定し得る限りにおいて任意に設定できる。例えば、上述した実施形態における本体部の載置面を基準にした場合、穿刺針の突出方向と載置面とがなす角度は、垂直な角度を含む任意の角度に設定できる。 Also, the protruding direction of the puncture needle can be arbitrarily set as long as the cannula can be fixed to the main body in a state where the cannula protrudes from the main body. For example, when the mounting surface of the main body in the above-described embodiment is used as a reference, the angle formed by the protruding direction of the puncture needle and the mounting surface can be set to an arbitrary angle including a vertical angle.
 本出願は、2016年2月4日に出願された日本特許出願番号2016-020275号に基づいており、その開示内容は、参照され、全体として、組み入れられている。 This application is based on Japanese Patent Application No. 2016-020275 filed on Feb. 4, 2016, the disclosure of which is incorporated by reference as a whole.
10 本体部、
12 載置面、
13  側壁、
13a  第1の側壁、
13a1 第1開口部、
13b  第2の側壁、
13b1 第2開口部、
16   付着部、
18   装着部、
20   穿刺針、
21   カニューレ、
22   内針、
30   筐体、
31   第1部材、
32   筒体、
32a  外周面、
32b  支持部、
32c  突起部、
32d  ガイド溝、
32e  側面、
32f  ロック壁、
33   脚部、
33a  第1の凹部、
33b  第2の凹部、
33c  開口部、
35   第2部材、
36   第1の筒体、
37   第2の筒体、
37a  第1のロック爪、
37b  第2のロック爪、
37c  外周面、
39   ツマミ部、
39a  凹部、
39b  規制面、
39c  鍵穴、
39d  突起、
39e  壁面、
40   セーフティキャップ、
40a  突起、
40b  係合爪、
100  穿刺装置、
110  穿刺機構、
111  穿刺針保持部、
112  付勢部材、
113  規制部、
113a 第1規制部、
113b 第2規制部、
120  固定機構、
130  第1保持部、
140  第2保持部、
141  主部材、
141a 基材、
141b 保持部、
141c 内腔、
141d 支柱、
141e 外周面、
142  副部材、
143  アーム、
143a 係合爪、
144  連結部材、
144a 支持部、
145  ロックアーム、
145c 係合爪、
150  係合部、
151  第1係合部、
152  第2係合部、
200  送出機構、
Z    穿刺針の突出方向、
d、h  距離。
10 Main body,
12 Placement surface,
13 side walls,
13a first sidewall,
13a1 first opening,
13b second side wall,
13b1 second opening,
16 Adhering part,
18 mounting part,
20 puncture needle,
21 cannula,
22 Inner needle,
30 housing,
31 first member,
32 cylinders,
32a outer peripheral surface,
32b support,
32c protrusion,
32d guide groove,
32e side,
32f lock wall,
33 legs,
33a first recess,
33b second recess,
33c opening,
35 second member,
36 first cylinder,
37 second cylinder,
37a first locking claw,
37b second lock claw,
37c outer peripheral surface,
39 Knob part,
39a recess,
39b regulatory aspects,
39c keyhole,
39d protrusion,
39e wall surface,
40 safety cap,
40a protrusion,
40b engaging claw,
100 lancing device,
110 Puncture mechanism,
111 puncture needle holder,
112 biasing member,
113 Regulatory Department,
113a 1st regulation part,
113b 2nd regulation part,
120 fixing mechanism,
130 first holding part,
140 second holding part,
141 main members,
141a base material,
141b holding part,
141c lumen,
141d strut,
141e outer peripheral surface,
142 secondary members,
143 arm,
143a engaging claw,
144 connecting member,
144a support,
145 lock arm,
145c engaging claw,
150 engaging portion,
151 first engaging portion,
152 second engaging portion,
200 delivery mechanism,
Z Projection direction of puncture needle,
d, h Distance.

Claims (10)

  1.  生体表面に貼り付け可能な本体部と、
     カニューレと当該カニューレ内に挿入された内針とを備える穿刺針と、
     前記穿刺針を収容する筐体と、
     前記筐体内に設けられ、前記穿刺針を前記本体部から突出させた後、前記カニューレを突出させたまま、前記内針を前記本体部から抜去可能にする穿刺動作を行う穿刺機構と、
     前記穿刺針が前記本体部から突出された状態において前記カニューレを前記本体部に固定する固定機構と、を有し、
     前記穿刺機構は、前記カニューレを保持する第1保持部および前記内針を保持する第2保持部を含む穿刺針保持部と、前記穿刺針を前記本体部から突出させる突出方向の付勢力を前記穿刺針保持部に付与する付勢部材と、を備え、
     前記固定機構は、前記第1保持部が前記本体部に対して前記突出方向とは異なる方向に相対的に移動する動作に伴って当該第1保持部を当該本体部に係合する係合部を備える、穿刺装置。
    A body that can be attached to the surface of a living body;
    A puncture needle comprising a cannula and an inner needle inserted into the cannula;
    A housing for housing the puncture needle;
    A puncture mechanism that is provided in the housing and performs a puncture operation that allows the inner needle to be removed from the main body while the cannula is protruded after the puncture needle protrudes from the main body.
    A fixing mechanism for fixing the cannula to the main body in a state where the puncture needle protrudes from the main body,
    The puncture mechanism includes a puncture needle holding portion including a first holding portion that holds the cannula and a second holding portion that holds the inner needle, and a biasing force in a protruding direction that causes the puncture needle to protrude from the main body portion. An urging member to be applied to the puncture needle holding unit,
    The fixing mechanism includes an engaging portion that engages the first holding portion with the main body portion as the first holding portion moves relative to the main body portion in a direction different from the protruding direction. A puncture device comprising:
  2.  前記係合部は、前記第1保持部側に設けられる第1係合部と、前記本体部側に設けられ、当該第1係合部に係合する第2係合部と、を備える、請求項1に記載の穿刺装置。 The engagement portion includes a first engagement portion provided on the first holding portion side, and a second engagement portion provided on the main body portion side and engaged with the first engagement portion. The puncture device according to claim 1.
  3.  前記係合部において、前記第1保持部と前記本体部とは、前記突出方向を軸に前記第1保持部が前記本体部に対して相対的に回転することによって係合する、請求項1または請求項2に記載の穿刺装置。 2. The engagement portion, wherein the first holding portion and the main body portion are engaged by rotating the first holding portion relative to the main body portion about the protruding direction. Or the puncture apparatus of Claim 2.
  4.  前記筐体は、前記本体部に対して相対的に回転することによって当該本体部から接続・分離可能に構成され、
     前記係合部において、前記第1保持部と前記本体部とは、前記突出方向を軸に前記筐体が前記本体部に対して相対的に回転する動作に連動して前記第1保持部が前記本体部に対して相対的に回転することによって係合し、
     前記本体部と前記筐体との接続は、前記係合部において前記第1保持部と前記本体部とが係合した状態において前記突出方向を軸に前記筐体が前記本体部に対して相対的に回転することによって解除される、請求項3に記載の穿刺装置。
    The housing is configured to be connectable / separable from the main body by rotating relative to the main body,
    In the engaging portion, the first holding portion and the main body portion are configured such that the first holding portion is interlocked with an operation in which the housing rotates relative to the main body portion with the protruding direction as an axis. Engaged by rotating relative to the main body,
    The connection between the main body and the housing is relative to the main body with respect to the projecting direction in a state where the first holding portion and the main body are engaged in the engagement portion. The puncture device according to claim 3, wherein the puncture device is released by rotating it automatically.
  5.  前記穿刺機構は、前記付勢力に抗して前記穿刺針保持部の移動を規制する規制部をさらに備え、
     前記規制部による規制は、前記突出方向を軸に前記筐体が前記本体部に対して相対的に回転する動作に連動して解除される、請求項4に記載の穿刺装置。
    The puncture mechanism further includes a restricting portion that restricts movement of the puncture needle holding portion against the biasing force,
    The puncture apparatus according to claim 4, wherein the restriction by the restriction portion is released in conjunction with an operation in which the housing rotates relative to the main body portion with the protruding direction as an axis.
  6.  前記筐体に接続・分離可能に構成されるとともに、前記筐体に接続された状態において前記本体部に対する前記筐体の回転を規制するセーフティキャップをさらに有する、請求項4または請求項5に記載の穿刺装置。 6. The device according to claim 4, further comprising a safety cap configured to be connectable and separable to the housing and restricting rotation of the housing relative to the main body in a state of being connected to the housing. Puncture device.
  7.  前記セーフティキャップは、前記本体部から前記筐体が分離された後に前記カニューレから抜去された前記内針を覆った状態で当該筐体に取り付け可能に構成される、請求項6に記載の穿刺装置。 The puncture device according to claim 6, wherein the safety cap is configured to be attachable to the housing in a state of covering the inner needle removed from the cannula after the housing is separated from the main body. .
  8.  前記本体部は、生体に貼り付け可能な付着部と、前記カニューレを介して所定の投与物を生体内へ送出する送出機構が装着可能な装着部を有するクレードルと、を備える、請求項1~7のいずれか1項に記載の穿刺装置。 The main body portion includes an attachment portion that can be attached to a living body, and a cradle having a mounting portion to which a delivery mechanism that delivers a predetermined dose into the living body can be attached via the cannula. The puncture device according to any one of 7.
  9.  カニューレを、生体表面に固定した状態で生体に対して留置する、カニューレの留置方法であって、
     前記カニューレと前記カニューレ内に挿入された内針とを備える穿刺針と、
     前記生体表面に貼り付け可能な本体部と、
     前記カニューレを保持する第1保持部および前記内針を保持する第2保持部を含む穿刺針保持部と、前記穿刺針を前記本体部から突出させる突出方向の付勢力を前記穿刺針保持部に付与する付勢部材と、が設けられた筐体と、
     を有する穿刺装置の前記本体部を前記生体表面に貼り付ける第1のステップと、
     前記筐体を、前記本体部に対して前記突出方向とは異なる方向に相対的に移動させることによって、前記付勢部材の付勢力を開放して、前記穿刺針を前記本体部から突出させる第2のステップと、
     前記本体部から前記穿刺針を突出させた状態において、前記筐体を、前記本体部に対して前記突出方向とは異なる方向に相対的に移動させることによって、前記第1保持部に設けられた係合部と前記本体部に設けられた係合部とを係合させる第3のステップと、
     前記第1保持部の前記係合部と前記本体部の前記係合部とを係合させた状態において、前記筐体を、前記本体部に対して前記突出方向とは異なる方向に相対的に移動させることによって、前記筐体と前記本体部との接続を解除して、前記筐体を、前記内針および前記第2保持部とともに、前記本体部から分離可能にする第4のステップと、を含む、カニューレの留置方法。
    A cannula indwelling method in which a cannula is indwelled with respect to a living body in a state of being fixed to a living body surface,
    A puncture needle comprising the cannula and an inner needle inserted into the cannula;
    A main body that can be attached to the surface of the living body;
    A puncture needle holding portion including a first holding portion for holding the cannula and a second holding portion for holding the inner needle, and a biasing force in a protruding direction for causing the puncture needle to protrude from the main body portion are applied to the puncture needle holding portion. An energizing member to be provided, and a housing provided with;
    A first step of affixing the main body of the puncture device to the surface of the living body;
    The urging force of the urging member is released by moving the housing relative to the main body in a direction different from the protruding direction, and the puncture needle protrudes from the main body. Two steps,
    In the state in which the puncture needle is protruded from the main body, the housing is provided in the first holding portion by moving the housing relative to the main body in a direction different from the protruding direction. A third step of engaging the engaging portion with the engaging portion provided in the main body portion;
    In a state in which the engagement portion of the first holding portion and the engagement portion of the main body portion are engaged, the housing is relatively moved in a direction different from the protruding direction with respect to the main body portion. A fourth step of releasing the connection between the casing and the main body by moving the casing and separating the casing together with the inner needle and the second holding section from the main body; A method for indwelling the cannula.
  10.  前記筐体を、前記本体部に対して前記突出方向とは異なる方向に相対的に移動させる操作によって、前記第1~4のステップを連続的に行う、請求項9に記載のカニューレの留置方法。 The cannula indwelling method according to claim 9, wherein the first to fourth steps are continuously performed by an operation of moving the casing relative to the main body in a direction different from the protruding direction. .
PCT/JP2016/088779 2016-02-04 2016-12-26 Puncture device and method for retaining cannula WO2017134966A1 (en)

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