WO2013171886A1 - Medical agent injection device - Google Patents

Medical agent injection device Download PDF

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Publication number
WO2013171886A1
WO2013171886A1 PCT/JP2012/062699 JP2012062699W WO2013171886A1 WO 2013171886 A1 WO2013171886 A1 WO 2013171886A1 JP 2012062699 W JP2012062699 W JP 2012062699W WO 2013171886 A1 WO2013171886 A1 WO 2013171886A1
Authority
WO
WIPO (PCT)
Prior art keywords
pusher
cylindrical body
injection device
filling member
shaft
Prior art date
Application number
PCT/JP2012/062699
Other languages
French (fr)
Japanese (ja)
Inventor
早川浩一
照屋雅和
井尻朋応
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 PCT/JP2012/062699 priority Critical patent/WO2013171886A1/en
Priority to PCT/JP2012/074831 priority patent/WO2013171922A1/en
Priority to JP2014515454A priority patent/JP6023185B2/en
Publication of WO2013171886A1 publication Critical patent/WO2013171886A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8822—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8825—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by syringe details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/1782—Devices aiding filling of syringes in situ
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8816—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/31573—Accuracy improving means
    • A61M5/31575—Accuracy improving means using scaling up or down transmissions, e.g. gearbox

Definitions

  • the present invention relates to a drug injection device used for discharging a drug when the drug is injected into an injection space.
  • PVP percutaneous vertebroplasty
  • a filling material that hardens with time through a bone biopsy needle inserted into the fractured vertebral body.
  • the filler for example, calcium phosphate bone cement or polymethylmethacrylate bone cement (hereinafter, also simply referred to as “bone cement”) having X-ray contrast properties is used.
  • bone cement has a very high viscosity, and the pressure loss due to the sponge is very large in the vertebra filled with the bone cement, so it is necessary to inject a small amount at a high pressure of 3 MPa or more at the time of injection. .
  • a configuration is used in which bone cement is discharged while applying a high pressure by a general piston type or feed screw type syringe.
  • a feed screw type drug injection device is disclosed in, for example, Japanese Patent Publication No. 2004-500963.
  • an extension tube is provided between the biopsy needle and the syringe, and the bone cement discharged from the syringe is injected into the bone through the extension tube.
  • An improved drug infusion device has been proposed.
  • a highly viscous bone cement is allowed to flow inside the elongated elongated tube, the pressure loss is large, and a syringe-type drug injection device requires a large operating force during a pressing operation and is difficult to inject.
  • the feed screw type drug injection device even in the injection using the extension tube, a relatively large amount of injection can be performed at a high pressure by a rotating operation with a relatively small operation force.
  • a feed screw type drug injection device generally includes a cylindrical body having a discharge port for discharging a drug at its tip and a pusher inserted into the cylindrical body, and the pusher has a male screw on its outer periphery. Having a formed shaft.
  • the present invention has been made in view of such problems, and an object of the present invention is to provide a drug injection device that can easily fill a cylindrical body with a drug.
  • the present invention provides a drug injection device for discharging a drug filled inside, a cylindrical body having a drug discharge port at a tip and filled with the drug, and the cylinder A pusher inserted into the hollow portion of the cylindrical body and having an insertion hole penetrating in the axial direction, and the pusher is displaced in the axial direction with respect to the cylindrical body as the pusher rotates relative to the cylindrical body.
  • a feed screw structure that has a head portion that is liquid-tightly inserted into the hollow portion of the cylindrical body on the tip side of the pusher, and a filling member that can be displaced in the axial direction with respect to the pusher;
  • the medicine is filled into the tubular body by retracting the filling member with respect to the tubular body, and the pusher is rotated and advanced to move the head portion in the distal direction.
  • the medicine filled in the cylindrical body is Characterized by discharging the agent ejection port.
  • medical agent when the front-end
  • the tip of the pusher has a tapered shape.
  • the pusher includes a shaft that is inserted into the cylindrical body, and the filling member extends from the head portion in the proximal direction and is inserted into a hollow portion of the shaft. It has a shaft part, and the shaft part may be separable into a first part on the distal end side and a second part on the proximal end side at a midway position in the axial direction.
  • the filling member does not get in the way when the pusher is rotated, so that the operability is excellent.
  • the shaft portion has a fragile portion at the intermediate position in the axial direction, and the first portion and the second portion are when a bending stress of a predetermined level or more acts on the shaft portion.
  • the fragile portion can be separated by breaking.
  • the shaft part separable into a plurality of parts can be configured with a small number of parts.
  • the pusher has a handle provided on the proximal end of the shaft, the handle, the shaft portion of the filling member may groove that can enter is provided.
  • the shaft portion when the filling member is folded and separated, the shaft portion enters the groove portion provided in the handle, so that the operation of folding the filling member shaft portion can be easily performed.
  • the filling member may include a grip portion provided at a proximal end of the shaft portion, and a bottomed recess may be provided in a side portion of the grip portion.
  • the operation of folding the shaft portion of the filling member can be easily performed by pressing the concave portion from the side of the grip portion.
  • the filling member has an air discharge path extending to an end surface of the head portion along the axial direction, and when the second portion is separated from the first portion, the air
  • the cylindrical body and the outside air may communicate with each other via the discharge path.
  • the cylindrical body in the air discharge operation performed after the medicine is filled in the cylindrical body, the cylindrical body does not face upward by moving the filling member forward with the shaft portion of the filling member separated.
  • the air in the cylindrical body can be easily and reliably discharged to the outside.
  • the shaft portion, the first protrusion is provided protruding outward, to the shaft, protrudes inwardly and the first convex portion engageable with the second protrusion
  • the first convex portion can get over the second convex portion, and when the filling member is retracted with respect to the pusher
  • the weak portion may be exposed to the outside from the base end of the shaft when the first convex portion and the second convex portion contact each other.
  • the movement resistance of the filling member is increased by the contact between the first convex portion and the second convex portion in the operation of filling the cylindrical body with the medicine.
  • the weak part provided in the axial part exists in the position exposed outside from the base end of the shaft of a pusher. Therefore, it is easy for the user to recognize the position where the shaft portion can be cut.
  • the pusher may be reversely rotated. In this case, the pusher is reversely rotated more than necessary by the engagement action of the first convex portion and the second convex portion. There is no.
  • the pusher is a first pusher
  • the filling member has a through-hole penetrating in the axial direction
  • the drug injection device is further inserted in the through-hole in the axial direction.
  • a second pusher inserted so as to be slidable in a liquid-tight manner may be provided.
  • FIG. 3A is a first diagram illustrating a method of filling a medicine injection device shown in FIG. 1 with a drug
  • FIG. 3B is a second diagram illustrating a method of filling the medicine injection device shown in FIG.
  • FIG. 4A is a first diagram for explaining a method of discharging air from the cylindrical body of the drug injection device shown in FIG. 1
  • FIG. 4B is a diagram illustrating discharging air from the cylindrical body of the drug injection device shown in FIG. It is the 2nd figure explaining the method to do.
  • FIG. 6A is a first diagram illustrating an operation method of the drug injection device illustrated in FIG. 1
  • FIG. 6B is a second diagram illustrating an operation method of the drug injection device illustrated in FIG. 1.
  • 8A is a first diagram illustrating a method of filling a drug in drug infusion device shown in FIG. 7, FIG. 8B, the second describing the method of filling a drug in drug infusion device shown in FIG. 7
  • FIG. 9A is a first view for explaining a method of discharging air from the cylindrical body of the drug injection device shown in FIG.
  • FIG. 7 discharges air from the cylindrical body of the drug injection device shown in FIG. It is the 2nd figure explaining the method to do.
  • FIG. 11A is a first diagram for explaining the operation of the drug injection device shown in FIG. 10, and
  • FIG. 11B is a second diagram for explaining the operation of the drug injection device shown in FIG.
  • 13A is a first diagram illustrating a method for filling a drug injecting device shown in FIG. 12, and
  • FIG. 13B is a second diagram illustrating a method for filling the drug injecting device shown in FIG. FIG.
  • FIG. 13C is a view for explaining a method of discharging air from the cylindrical body of the pharmaceutical injection device shown in FIG. 14A is a first diagram illustrating a first operation method of the drug injection device shown in FIG. 12, and FIG. 14B is a second diagram illustrating a first operation method of the drug injection device shown in FIG.
  • FIG. 15A is a first diagram illustrating a second method of operation of the infusion device shown in FIG. 12, FIG. 15B, the second describing the second method of operation of the infusion device shown in FIG. 12
  • FIG. 16A is a third diagram illustrating a second method of operation of the infusion device shown in FIG. 12, FIG. 16B, the fourth explaining a second method of operation of the infusion device shown in FIG. 12 FIG.
  • FIG. 1 is an exploded perspective view showing a pharmaceutical injection device 10A according to the first embodiment of the present invention.
  • FIG. 2 is a longitudinal sectional view of the pharmaceutical injection device 10 shown in FIG. 1 in an assembled state.
  • the drug injection tool 10 is a medical device used for discharging a drug when a drug (filler, injection material) is injected into a desired injection space. For example, bone cement in percutaneous vertebroplasty. Is used to inject into the bone.
  • bone cement such as calcium phosphate bone cement (CPC) or polymethyl methacrylate (PMMA) bone cement
  • CPC calcium phosphate bone cement
  • PMMA polymethyl methacrylate
  • CPC calcium phosphate bone cement
  • alumina ceramics calcium phosphate ceramics and alumina ceramics.
  • Granules made of inorganic materials such as zirconia ceramics and titanium can also be used.
  • the drug injection device 10 includes a cylindrical body 12 that is filled with a drug, a pusher 14 that is inserted into a hollow portion of the cylindrical body 12, and a pusher 14 that can advance and retract. And a filling member 16 inserted therethrough.
  • the cylindrical body 12 includes a body portion 18 having a lumen (hollow portion) extending in the axial direction, a distal end tube portion 20 protruding from the distal end portion of the body portion 18 toward the distal end side, and a proximal end portion of the body portion 18. And an annular flange portion 22 projecting outward (radially outward) and extending in the circumferential direction.
  • a filling chamber for filling a medicine is formed by a space surrounded by the cylindrical body 12 and the filling member 16.
  • a drug discharge port 12 a is provided at the distal end of the cylindrical body 12, and a proximal end opening 12 b is provided at the proximal end of the cylindrical body 12.
  • the body part 18, the distal end pipe part 20, and the flange part 22 are integrally formed.
  • the body portion 18 includes a parallel portion 18a having a constant inner diameter and a tapered portion 18b that decreases in diameter from the tip of the parallel portion 18a toward the tip tube portion 20, and is formed in a hollow cylindrical shape as a whole.
  • a scale 19 indicating the amount of the medicine is provided on the outer peripheral surface of the body portion 18.
  • the distal end tube portion 20 forms the medicine discharge port 12a and is configured as a luer connector.
  • a lock portion 28 that protrudes in the axial direction from the tip portion of the body portion 18 concentrically with the tip tube portion 20 and has an internal thread portion 27 formed on the inner peripheral surface is provided.
  • the medicine is injected by such a distal end pipe part 20 and the lock part 28, it can be connected to an extension tube 88 or a bone cement injection needle 92 (see FIG. 6A and the like) described later.
  • the flange portion 22 has a non-circular shape.
  • the flange portion 22 includes a pair of straight portions 22a that are parallel to each other and a pair of arc portions 22b that connect both ends of the straight portions.
  • the non-circular flange portion 22 engages with the cover member 52 such as an ellipse, a polygon, or a shape protruding outward in a part of the circumferential direction. Any shape can be used.
  • the constituent material of the cylindrical body 12 is not particularly limited.
  • polyolefin such as polypropylene, polyurethane, polyethylene, cyclic polyolefin, polymethylpentene 1, polyester, nylon, polycarbonate, polymethylmethacrylate (PMMA), polyetherimide ( PEI), polyethersulfone, polyetheretherketone (PEEK), fluororesin, polyphenylene sulfide (PPS), polyacetal resin (POM) and other resinous materials, stainless steel and other metallic materials, glass, etc.
  • PMMA polymethylmethacrylate
  • PEI polyetherimide
  • PEEK polyethersulfone
  • PES polyetheretherketone
  • fluororesin polyphenylene sulfide
  • PPS polyacetal resin
  • the constituent material of the cylindrical body 12 is substantially transparent in order to ensure internal visibility.
  • the pusher 14 includes a shaft 30 that can be inserted into the hollow portion of the cylindrical body 12, and a hollow handle 32 that is provided at the base end of the shaft 30 and has an outward diameter (radially outward).
  • the pusher 14 can be displaced in the axial direction relative to the filling member 16 and can be relatively rotated in the circumferential direction.
  • the shaft 30 has an insertion hole 30a (see FIG. 2) penetrating linearly in the axial direction.
  • Head 31 constituting the distal portion of the shaft 30, has a tapered shape that decreases in diameter toward the distal end side, the leading edge surface has a circular front end surface 31a of the small area.
  • the annular tip surface 31 a is a surface perpendicular to the axis of the shaft 30.
  • a male thread portion 34 is formed along the axial direction in a predetermined range in the longitudinal direction on the outer peripheral portion of the shaft 30.
  • the outer diameter of the male screw portion 34 is smaller than the inner diameter of the body portion 18 of the cylindrical body 12.
  • a guide member 36 that can be connected to the cover member 52 is attached to the male screw portion 34. The configuration of the guide member 36 will be described later.
  • the handle 32 is a portion that a user grips (pinch) with fingers when rotating the pusher 14 with respect to the cylindrical body 12 about the axis, and in this embodiment, from the proximal end of the shaft 30. It extends in the proximal direction so as to at least partially cover the protruding filling member 16.
  • the handle 32 includes a flange portion 32a extending radially outward from the proximal end portion of the shaft 30, and a cover portion 32b extending in the proximal direction from the outer end of the flange portion 32a.
  • a plurality of grooves may be formed on the outer periphery of the cover portion 32b at intervals in the circumferential direction so that the user does not slip when gripping and rotating.
  • the handle 32 (specifically, the cover portion 32b) is provided with a cutout portion 38 that extends along the axial direction of the shaft 30 and is opened in the proximal direction of the handle 32.
  • two notches 38 are provided at symmetrical positions (positions where the phase is shifted by 180 degrees) with respect to the center (axis) of the shaft 30.
  • the notch 38 is large enough to allow the user's finger to be inserted. It is good to be formed.
  • a groove portion 40 into which the shaft portion 44 of the filling member 16 can enter is provided on the distal end side of the notch portion 38.
  • the groove portion 40 has a shape that communicates the inside and outside of the cover portion 32b and opens in the proximal direction of the cover portion 32b.
  • the width of the groove portion 40 is larger than the thickness (outer diameter) of the shaft portion 44 of the filling member 16.
  • the distal end position of the groove portion 40 may be in the vicinity of the most proximal end portion of the shaft 30.
  • the constituent material of the pusher 14 can be selected from those exemplified as the constituent material of the cylindrical body 12 described above.
  • Filling member 16 by being operated to move proximally when filling the drug through the drug discharge port 12a the cylindrical body 12, be a device for sucking the drug into the cylindrical body 12
  • the pusher 14 is disposed so as to be displaceable in the axial direction.
  • the filling member 16 includes a head portion 42 which is inserted in a liquid-tight manner to the hollow portion of the cylindrical body 12 at the distal end side of the pusher 14, provided on the pushers 14 extends from the head portion 42 in the proximal direction
  • the shaft portion 44 is inserted into the insertion hole 30a, and the grip portion 45 is provided at the base end of the shaft portion 44.
  • the head portion 42 is a portion that constitutes the distal end portion of the filling member 16, and is within the range restricted by the tapered portion 18 b of the cylindrical body 12 and the head portion 31 of the pusher 14 in the cylindrical body 12. It can move in the axial direction.
  • a seal member 46 is attached to the head portion 42.
  • an annular seal groove 47 (see FIG. 2) extending in the circumferential direction is formed on the outer periphery of the head portion 42, and a ring-shaped seal member 46 (for example, a silicone O-ring) is formed in the seal groove 47. Is placed.
  • Such a seal member 46 slides in the axial direction while being in close contact with the inner peripheral surface of the cylindrical body 12, so that liquid-tightness can be reliably maintained and slidability can be improved.
  • the constituent material of the seal member 46 is not particularly limited.
  • a gasket made of an elastic resin material may be attached to the tip of the filling member 16.
  • the outer diameter of the front end portion of the filling member 16 (in the illustrated example, the outer diameter of the seal member 46 assembled in the head portion 42) is the same as or slightly smaller than the inner diameter of the body portion 18 of the cylindrical body 12, For example, it is set to about 5 to 50 mm, and more preferably set to about 10 to 20 mm. If the outer diameter of the seal member 46 assembled in the head portion 42 is too large, the operation force when rotating the pusher 14 of the drug injection device 10A filled with a high-viscosity drug becomes too large, Operation becomes difficult. In addition, if the outer diameter of the seal member 46 assembled in the head portion 42 is too small, it becomes difficult to maintain liquid tightness with the body portion 18 of the cylindrical body 12.
  • the shaft portion 44 is smaller in diameter than the insertion hole 30a provided in the shaft 30 of the pusher 14, and is inserted into the insertion hole 30a so as to be slidable in the axial direction.
  • the user grips the gripping portion 45 and sucks it.
  • the force when the operation is performed that is, the operation force in the axial direction from the user input to the grip portion 45 is transmitted to the head portion 42 described above. Since the head portion 42 slidably inserted into the cylindrical body 12 is moved in the axial direction, the total length of the shaft portion 44 is longer than the total length of the shaft 30 of the pusher 14.
  • the shaft portion 44 can be separated into a first portion 44A on the distal end side and a second portion 44B on the proximal end side at an intermediate position in the axial direction.
  • the shaft portion 44 has a fragile portion 48 (see FIG. 2) at an intermediate position in the axial direction.
  • the fragile portion 48 is an annular groove having a V-shaped cross section. That is, the weakened part 48 is a part whose strength is relatively smaller than that of the other part by being formed with a narrower diameter than the other part by the annular groove having a V-shaped cross section. Therefore, the first portion 44 ⁇ / b> A and the second portion 44 ⁇ / b> B can be separated by the fragile portion 48 being broken when a predetermined bending stress or more is applied to the shaft portion 44.
  • the second portion 44 ⁇ / b> B is moved at the position of the fragile portion 48. Separated from the first portion 44A.
  • the filling member 16 at the end of the air discharge operation is not located at the last retracted position of the movable range, but is located at a position where it has advanced to the tip side to some extent from the last retracted position. Further, the position of the filling member 16 at the end of the air discharge operation depends on the amount of medicine filled in the cylindrical body 12. On the other hand, in order to cause a bending stress to act on the shaft portion 44 and break the shaft portion 44 at the weakened portion 48, the weakened portion 48 needs to be exposed to the outside.
  • the fragile portion 48 is positioned closer to the proximal end side than the shaft 30 of the pusher 14 (shaft 30 ).
  • the position of the fragile portion 48 is set so that it is exposed behind.
  • the structure which makes it possible to separate the first part 44A and the second part 44B is not limited to the configuration by the fragile portion 48 described above.
  • the first part 44A and the second part 44B made of different parts are connected by physical engagement such as fitting and screwing, and a tensile stress, bending stress or rotational stress exceeding a predetermined level is applied.
  • a configuration in which the connection between the first portion 44A and the second portion 44B is released may be employed.
  • the grip portion 45 is a portion that is gripped (pulled) and pulled by the user when filling the cylindrical body 12 with a medicine, and is formed in a flat shape wider than the shaft portion 44 in this embodiment.
  • a bottomed recess 50 is provided on the side of the grip 45.
  • the concave portions 50 are provided on both surfaces of the grip portion 45.
  • the concave portion 50 may be provided only on one side surface of the grip portion 45.
  • the shape of the gripping portion 45 may be any shape that can be pulled in the proximal direction when filling the bone cement and can be pressed in the radial direction when the shaft portion 44 is broken. Further, a shape in which a through hole is provided in the side portion may be used. Further, by providing the through hole, the user's finger can be hooked when the filling member 16 is moved backward with respect to the cylindrical body 12.
  • the pharmaceutical injection device 10 ⁇ / b> A further includes a cover member 52 that covers the periphery of the cylindrical body 12.
  • the cover member 52 has a cylindrical shape with both ends opened, and the cylindrical body 12 can be inserted from the base end side. In the state where the cover member 52 and the guide member 36 are coupled, the cover member 52 is prevented from moving in the axial direction with respect to the cylindrical body 12, but in the state where the cover member 52 and the guide member 36 are separated, the cover member 52 is covered.
  • the member 52 can be displaced in the axial direction with respect to the cylindrical body 12.
  • the cover member 52 has a length that can substantially cover the cylindrical body 12.
  • the distal end (the distal end pipe portion 20) of the cylindrical body 12 is a cover. Projecting from the tip of the member 52.
  • the cover member 52 includes a fitting portion 54 that fits (contacts) with the outer peripheral portion of the inserted tubular body 12, and an enlarged diameter portion that has an inner diameter larger than the inner diameter of the fitting portion 54. 56.
  • the fitting portion 54 is provided only in a predetermined range constituting the proximal end portion of the cover member 52 and has an inner diameter that is substantially the same as the outer diameter of the cylindrical body 12.
  • a female screw portion 58 to which the guide member 36 can be screwed is provided on the inner periphery of the base end portion of the cover member 52.
  • the enlarged diameter portion 56 constitutes a portion (a portion other than the proximal end portion) extending from the distal end portion to the vicinity of the proximal end portion in the cover member 52 and has an inner diameter larger than the outer diameter of the cylindrical body 12. For this reason, in a state where the cylindrical body 12 is inserted through the cover member 52, an annular gap 60 (air) extending in the axial direction between the inner peripheral surface of the cover member 52 and the outer peripheral surface of the cylindrical body 12. Layer) is formed.
  • the void 60 functions as a heat insulating layer.
  • the cover member 52 and the guide member 36 may be integrally formed.
  • a protruding part that partially protrudes is provided on the outer peripheral part of the cylindrical body 12 or the inner peripheral part of the cover member 52, and the outer peripheral part of the cylindrical body 12 and the inner peripheral part of the enlarged diameter portion 56 of the cover member 52 are provided. Partial contact may be made. Even in this case, the gap 60 is formed between the outer peripheral portion of the cylindrical body 12 and the inner peripheral portion of the enlarged diameter portion 56.
  • a protrusion or groove extending in the axial direction may be provided in part on the outer periphery of the cover member 52. This makes it difficult for the user's hand to slip when gripping the cover member 52 during the injection operation.
  • the constituent material of the cover member 52 can be selected from those exemplified as the constituent material of the cylindrical body 12 described above. Further, the cover member 52 itself may be made of a heat insulating material such as foamed polystyrene. Further, the gap 60 may have a mesh structure or a beam structure. The cover member 52 is desirably transparent enough to allow the medicine in the cylindrical body 12 to be visually recognized.
  • the drug injection device 10 has a guide for stably displacing the pusher 14 in the axial direction along with the rotation of the pusher 14 with respect to the cylindrical body 12.
  • a member 36 is provided.
  • the guide member 36 includes a base portion 62 in which a female screw portion 61 that can be screwed into a male screw portion 34 provided on the shaft 30 of the pusher 14 is formed, and a base portion 62 that is radially outward from the female screw portion 61.
  • a threaded cylinder 66 extending from the front surface in the distal direction and having a male threaded portion 64 formed on the outer periphery.
  • the female screw portion 61 can be screwed with the male screw portion 34 provided on the pusher 14.
  • the male screw portion 64 provided on the screw cylinder 66 of the guide member 36 can be screwed with the female screw portion 58 provided on the cover member 52.
  • the cylindrical body 12 is rotated with the rotation of the pusher 14 with respect to the cylindrical body 12 by the female screw part 61 provided on the guide member 36 and the male screw part 34 provided on the pusher 14.
  • a feed screw structure 70 (see FIG. 2) for displacing the pusher 14 in the axial direction is configured.
  • As a constituent material of the guide member 36 it can select from what was illustrated as a constituent material of the cylindrical body 12 mentioned above.
  • the flange portion 22 of the cylindrical body 12 is configured such that the guide member 36 (specifically, the end surface of the screw cylinder 66 of the guide member 36) and the cover member. 52 (specifically, the base end surface of the fitting portion 54 of the cover member 52) is sandwiched in the axial direction.
  • the guide member 36 is fixed so as not to move relative to the cylindrical body 12 in the axial direction. That is, in this embodiment, the guide member 36 has not only a function of guiding the movement of the pusher 14 with respect to the cylindrical body 12 but also a function as a connecting means for fixing the cylindrical body 12 and the cover member 52 to each other. Have both.
  • the flange portion 22 fits writes portion 72 of the tubular member 12 is formed into a groove shape corresponding to the flange portion 22. For this reason, in the state where the guide member 36 and the cover member 52 are connected by screw fitting, the relative rotation between the cover member 52 and the cylindrical body 12 is prevented by the engagement between the portion 72 and the flange portion 22. Is done. That is, the portion 72 and the flange portion 22 constitute a rotation preventing means for preventing relative rotation of the cylindrical body 12 and the cover member 52 in the circumferential direction.
  • the means for preventing the relative rotation between the cylindrical body 12 and the cover member 52 is not limited to the configuration shown in FIG. 1 and the like.
  • one of the outer peripheral portion of the cylindrical body 12 and the inner peripheral portion of the cover member 52 is used.
  • a protrusion is provided on the other side, and a groove that engages with the protrusion is provided on the other side. The engagement between the protrusion and the groove prevents relative rotation of the cylindrical body 12 and the cover member 52 in the circumferential direction. Also good.
  • the drug injection device 10A is basically configured as described above, and the operation and effect thereof will be described below.
  • the drug injector 10A is inserted into the cylindrical body 12 with the pusher 14 and the filling member 16 and the cover member 52 and the guide member 36 are connected. To. In this case, the pusher 14 is moved to the proximal end side of the movable range, and the filling member 16 is moved to the most distal side of the movable range.
  • the suction port 80 functioning as a nozzle is screwed into the distal end tube portion 20 of the cylindrical body 12 and attached.
  • a male screw portion 82 that can be screwed into a female screw portion 27 (see FIG. 1) provided on the inner peripheral portion of the lock portion 28 is provided on the outer periphery of the proximal end of the suction port 80.
  • the filling member 16 is pulled in the proximal direction with respect to the tubular body 12 with the distal end portion of the suction port 80 buried in the bone cement 86.
  • the handle 32 of the pusher 14 since the handle 32 of the pusher 14 is provided with the notch 38, the user can hook his / her finger on the grip 45 through the notch 38, so that the pulling operation can be easily performed. It can be carried out.
  • the filling member 16 is pulled in the proximal direction as described above, the bone cement 86 is sucked into the cylindrical body 12 through the suction port 80 and the distal end tube portion 20 as the filling member 16 moves. Thereby, as shown in FIG. 3B, the bone cement 86 is filled into the cylindrical body 12.
  • the filling amount of the bone cement 86 into the cylindrical body 12 is, for example, about 5 to 20 mL.
  • the suction port 80 is disconnected from the distal end tube portion 20 of the cylindrical body 12.
  • the tip of the medicine injection tool 10A is turned upward, and the apparatus waits for a while in this state. Then, the air gradually rises in the bone cement 86 and finally goes out above the bone cement 86.
  • FIG. 4B when the pusher 14 is rotated in the circumferential direction relative to the cylindrical body 12 and advanced, the distal end surface of the pusher 14 comes into contact with the proximal end surface of the head portion 42 of the filling member 16. The filling member 16 is pushed up (advanced) by the pusher 14. Then, the air can be completely discharged from the cylindrical body 12 by advancing the filling member 16 by an amount corresponding to the volume of air existing at the end of filling the bone cement 86.
  • the filling member 16 is then separated by separating the second portion 44B from the first portion 44A of the filling member 16 as shown in FIG. A separation operation for removing a rear portion from the second portion 44B is performed.
  • the shaft portion 44 is bent at the weakened portion 48 and broken. As a result, the second portion 44B of the filling member 16 is separated from the first portion 44A.
  • the cylindrical body 12 of the drug injection device 10A and the injection port 94 of the bone cement injection needle 92 pierced into the bone 90 to be injected with the bone cement 86 are connected via the extension tube 88. Link.
  • the medicine injection tool 10A can be operated with the user's hand retracted outside the X-ray irradiation region.
  • the bone cement injection needle 92 includes a hollow puncture needle 96 made of, for example, a metal material, and a handle 98 made of, for example, a resin material fixed to the proximal end portion of the puncture needle 96.
  • a hollow puncture needle 96 made of, for example, a metal material
  • a handle 98 made of, for example, a resin material fixed to the proximal end portion of the puncture needle 96.
  • An injection port 94 communicating with the lumen (hollow portion) of the puncture needle 96 is provided on the upper portion of the handle 98.
  • One end of the extension tube 88 is provided with a connector 100 that is detachably connected to the injection port 94, and the other end of the extension tube 88 is a connector that is detachable from the distal end tube portion 20 and the lock portion 28 of the cylindrical body 12. 102 is provided.
  • the extension tube 88 preferably has a structure in which a thread such as Kevlar (registered trademark), nylon, polyphenylene sulfide, stainless steel or the like is wound around a flexible tube wall or on the outer surface in a net or coil shape. However, it may be a multi-layer tube in which chemical resistant polypropylene or fluororesin is disposed only on the inner surface.
  • the length of the extension tube 88 is preferably set to about 200 to 500 mm so that the user's hand can be reliably retracted outside the X-ray irradiation region. Further, the distal end portion of the extension tube 88 may be angled.
  • the connector 100 provided at one end of the extension tube 88 is connected to the injection port 94 of the handle 98, and the connector 102 provided at the other end of the extension tube 88 is the tip tube portion of the cylindrical body 12. 20 and the lock portion 28.
  • the bone cement 86 filled in the drug injection device 10A is discharged and injected into the bone 90 under fluoroscopy.
  • the pusher 14 is rotated to move the filling member 16 together with the pusher 14 toward the distal end side with respect to the cylindrical body 12. That is, since the filling member 16 is pressed in the distal direction by the pusher 14 at the portion of the head portion 42, the filling member 16 is also moved in the distal direction as the pusher 14 moves in the distal direction.
  • the drug injection device 10A is configured to prevent rotation of the cylindrical body 12 and the cover member 52 in the circumferential direction (a flange portion 22 of the cylindrical body 12 and a portion 72 of the cover member 52, see FIG. 1). Therefore, even if the pusher 14 is rotated while the cover member 52 is gripped, the cylindrical body 12 can be prevented from being rotated. For this reason, the extension tube 88 or the bone cement injection needle 92 connected to the cylindrical body 12 can be prevented from rotating with the rotation of the pusher 14, and the procedure is not hindered.
  • the filling chamber in the cylindrical body 12 is pressurized to a high pressure, and the bone cement 86 is replaced with the distal end pipe portion 20, the extension tube 88, and the bone. It is injected into the bone 90 through a cement injection needle 92.
  • the bone cement 86 is injected to the target injection amount by such a rotation operation with respect to the pusher 14.
  • the periphery of the cylindrical body 12 is covered with the cover member 52, and the gap 60 (see FIG. 2) formed between the cylindrical body 12 and the cover member 52 functions as a heat insulating layer.
  • the body temperature is suppressed from being transmitted to the bone cement 86 in the tubular body 12 through the user's fingers during operation. Therefore, the increase rate of the viscosity of the bone cement 86 can be suppressed.
  • the pharmaceutical injection device 10A includes the filling member 16 provided with the head portion 42 that is liquid-tightly inserted into the hollow portion of the cylindrical body 12 on the tip side of the pusher 14.
  • the filling member 16 provided with the head portion 42 that is liquid-tightly inserted into the hollow portion of the cylindrical body 12 on the tip side of the pusher 14.
  • the pusher 14 since the pusher 14 can be rotated in the circumferential direction with respect to the filling member 16, the pusher 14 is rotated to discharge the medicine, and the filling member 16 is moved to the tip by the pusher 14.
  • the filling member 16 When moving in the direction, the filling member 16 does not substantially rotate with respect to the cylindrical body 12, and only the pusher 14 rotates with respect to the cylindrical body 12. That is, since there is a frictional resistance between the seal member 46 attached to the outer peripheral part of the head part 42 and the inner peripheral surface of the cylindrical body 12 and a frictional resistance between the head part 42 and the medicine, the distal end face of the pusher 14 Even if the pusher 14 rotates with the base end surface of the head portion 42 in contact with the filling member 16, the filling member 16 does not substantially rotate. Therefore, it is possible to effectively reduce the operating force required to rotate the pusher 14, and the operability is excellent.
  • the distal end portion of the pusher 14 has a tapered shape, the contact area between the annular distal end surface 31a (see FIGS. 1 and 2) of the head portion 31 and the proximal end surface of the head portion 42 is considerably small. . For this reason, the frictional resistance between the annular distal end surface 31a and the base end surface of the head portion 42 is suitably suppressed, and the operation force required for the rotation operation of the pusher 14 can be further effectively reduced.
  • the shaft portion 44 of the pusher 14 can be separated into a first portion 44A on the distal end side and a second portion 44B on the proximal end side at an intermediate position in the axial direction. According to this configuration, after separating the second part 44B from the first part 44A after filling the cylindrical body 12, the filling member 16 does not get in the way when the pusher 14 is rotated, Excellent operability.
  • the shaft portion 44 has a fragile portion 48 at an intermediate position in the axial direction, and the first portion 44A and the second portion 44B are subjected to a bending stress of a predetermined level or more on the shaft portion 44. At this time, the fragile portion 48 is broken and can be separated.
  • the handle 32 of the pusher 14 is provided with a groove portion 40 (see FIG. 1) into which the shaft portion 44 of the filling member 16 can enter.
  • the shaft portion 44 enters the groove portion 40 provided in the handle 32, so that the shaft of the filling member 16 is removed. The operation of folding the portion 44 can be easily performed.
  • a bottomed concave portion 50 (see FIG. 1) is provided on the side portion of the gripping portion 45 of the filling member 16, so that the filling is performed by pressing the concave portion 50 from the side of the gripping portion 45.
  • the operation of folding the shaft portion 44 of the member 16 can be easily performed.
  • a pressure gauge for the user to check the injection pressure may be provided on a part of the distal end tube portion 20 or the extension tube 88 of the cylindrical body 12 of the drug injection device 10A described above.
  • FIG. 7 is a longitudinal sectional view of a pharmaceutical injection device 10B according to the second embodiment of the present invention.
  • elements having the same or similar functions and effects as those of the drug injection device 10A according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted. To do.
  • the drug injection device 10B is different from the drug injection device 10A according to the first embodiment described above in the configuration of the filling member 110.
  • the filling member 110 has an air discharge path 112 extending to the distal end surface of the head portion 42 along the axial direction, and when the second portion 44B is separated from the first portion 44A, the air discharge passage.
  • the inside of the cylindrical body 12 and the outside air communicate with each other through 112.
  • the base end side of the air discharge path 112 does not communicate with the outside air until the second part 44B is separated from the first part 44A.
  • the air discharge path 112 shown in FIG. 7 is a pore provided in the shaft portion 44. In FIG.
  • the air discharge path 112 extends to the front end surface of the head portion 42, but it may extend to the side surface of the head portion 42 as long as it is on the front end side from the seal member 46. Good.
  • the base end of the air discharge path 112 reaches the base end of the shaft portion 44, but it is sufficient that it reaches at least a portion where the fragile portion 48 is present.
  • the air discharge path 112 is configured by pores, the number of the pores is not limited to one, and a plurality of pores may be provided in parallel in the shaft portion 44.
  • the air discharge path 112 may be formed of a porous body having pores communicating with each other.
  • the structure of the other parts of the filling member 110 is the same as that of the filling member 16 in the first embodiment.
  • the pusher 14 and the filling member 110 are inserted into the cylindrical body 12 and the cover member 52 and the guide member 36 are connected. Put it in a state. In this case, the pusher 14 is moved to the proximal end side of the movable range, and the filling member 110 is moved to the most distal side of the movable range.
  • the suction port 80 is screwed and attached to the lock portion 28 of the cylindrical body 12, and the tip of the suction port 80 is buried in the bone cement 86.
  • the attachment of the suction port 80 to the cylindrical body 12 may be performed before the cover member 52 and the guide member 36 are connected.
  • the filling member 110 when the distal end portion of the suction port 80 is buried in the bone cement 86 in the container 84, when the filling member 110 is pulled in the proximal direction with respect to the cylindrical body 12, the filling is performed. As the member 110 moves, the bone cement 86 is sucked into the cylindrical body 12 through the suction port 80 and the distal end tube portion 20. Thereby, the bone cement 86 is filled in the cylindrical body 12.
  • the filling amount of the bone cement 86 into the cylindrical body 12 is, for example, about 5 to 20 mL.
  • the head portion 42 of the filling member 110 is pushed down by the head 31 of the pusher 14, thereby lowering the filling member 110.
  • the air in the cylindrical body 12 is discharged to the outside through the air discharge path 112. Then, the air can be completely discharged from the cylindrical body 12 by lowering the filling member 110 by an amount corresponding to the volume of air existing at the end of filling the bone cement 86.
  • the highly viscous and hardened bone cement 86 hardens in the process of passing through the thin air discharge passage 112, the bone cement 86 hardly leaks from the proximal end of the first portion 44A.
  • the shaft portion 44 of the filling member 110 is connected to the first portion 44A and the second portion.
  • the air in the cylindrical body 12 can be discharged to the outside easily, quickly and reliably without the cylindrical body 12 being directed upward. it can.
  • FIG. 10 is a longitudinal sectional view of a pharmaceutical injection device 10C according to the third embodiment of the present invention. Note that in the drug injection device 10C according to the third embodiment, elements having the same or similar functions and effects as those of the drug injection device 10A according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted. To do.
  • the drug injection device 10C is different from the drug injection device 10A according to the first embodiment described above in the configuration of the filling member 120 and the pusher 122.
  • the shaft portion 44 of the filling member 120 is provided with a first convex portion 124 that protrudes outward.
  • the first convex portion 124 is an annular protrusion that bulges outward in the radial direction from the other portion of the shaft portion 44, and is provided near the tip of the shaft portion 44.
  • the shaft 30 is provided with a second convex portion 126 that protrudes inward and engages with the first convex portion 124.
  • the second protrusion 126 is an annular protrusion that bulges radially inward from the other portion of the insertion hole 30 a of the shaft 30, and is provided at the tip of the shaft 30 in this embodiment.
  • the outer diameter of the first convex portion 124 is larger than the inner diameter of the second convex portion 126. Therefore, as shown in FIG. 11A, when the filling member 120 is pulled and moved in the proximal direction in order to fill the cylindrical body 12 with a medicine (for example, bone cement 86), the first convex portion 124 and the first protrusion 124 are eventually formed. The two convex portions 126 come into contact.
  • the weak part 48 and the first convex part 124 provided on the shaft part 44 and the second convex part 126 provided on the shaft 30 are the weak part when the first convex part 124 and the second convex part 126 contact each other. 48 is set to be exposed from the base end of the shaft 30 to the outside.
  • Other portions of the filling member 120 are configured in the same manner as the filling member 16 in the first embodiment.
  • Other portions of the pusher 122 are configured in the same manner as the pusher 14 in the first embodiment.
  • the medicine injection device 10C configured as described above, in the process of moving the filling member 120 in the proximal direction in order to fill the cylindrical body 12, the first protrusion 124 and the second protrusion When 126 comes into contact, the movement resistance of the filling member 16 increases. At this position, the fragile portion 48 provided in the shaft portion 44 is in a position exposed to the outside from the base end of the shaft of the pusher 14. Accordingly, the position where the shaft portion 44 can be cut is easily recognized by the user.
  • the filling member 16 when the filling member 120 is further pulled, the filling member 16 can be further moved in the proximal direction by the first protrusion 124 getting over the second protrusion 126.
  • the medicine injection device 10 ⁇ / b> C when a predetermined axial force or more acts on the filling member 120, the first convex portion 124 can get over the second convex portion 126.
  • the head unit 42 is capable of pulling the filler member 120 to a position abutting the head 31 of the shaft 30 in the proximal direction.
  • the pusher 122 may be rotated in the reverse direction. Then, since the filling member 120 including the head portion 42 is retracted by the pressure from the medicine, the pressure in the system is surely released, so that the injection can be stopped suddenly and accurate injection can be ensured.
  • the distance L between the first convex portion 124 in a state where the head portion 42 and the head 31 is in contact with the second protrusion 126, required for depressurization The distance is set such that the head unit 42 can move backward by an amount corresponding to the volume (for example, about 1 mL).
  • FIG. 12 is a longitudinal sectional view of a pharmaceutical injection device 10D according to the fourth embodiment of the present invention.
  • the drug injection tool 10D is an instrument used for discharging a drug when the drug is injected into a desired injection space.
  • the drug injection device 10 ⁇ / b> D includes a cylindrical body 130, a first pusher 132, a filling member 134, a second pusher 136, a guide member 138, and a cover member 140.
  • the cylindrical body 130, the guide member 138, and the cover member 140 in the drug injection device 10D are configured in the same manner as the guide member 36 and the cover member 52 in the drug injection device 10A according to the first embodiment.
  • the first pusher 132 includes a shaft 142 that can be inserted into the hollow portion of the cylindrical body 130, and a hollow handle 144 that is provided at the proximal end of the shaft 142 and has an outer diameter (radially outward). .
  • the first pusher 132 is displaceable in the axial direction with respect to the filling member 134 and is relatively rotatable in the circumferential direction.
  • the shaft 142 is configured in the same manner as the shaft 30 of the pusher 14 in the first embodiment.
  • the handle 144 extends in the proximal direction so as to at least partially cover the second pusher 136 protruding from the proximal end of the shaft 142.
  • the handle 144 includes a flange portion 144a extending radially outward from the proximal end portion of the shaft 142, and a cover portion 144b extending from the outer end of the flange portion 144a in the proximal direction.
  • the handle 144 (specifically, the cover portion 144b) is provided with a notch portion 146 that extends along the axial direction of the shaft 142 and is opened in the proximal direction of the handle 144.
  • two notches 146 are provided at symmetrical positions (positions that are 180 degrees out of phase) with respect to the center (axis) of the shaft 142.
  • the notch 146 is preferably formed to a size that allows a user's finger to be inserted.
  • the handle 144 is not provided with the groove portion 40 (see FIG. 1) as provided in the handle 32 in the first embodiment.
  • Filling member 134 by being operated to move proximally when filling the drug through the drug discharge port 12a the cylindrical body 130, be a device for sucking the drug in the cylindrical body 130
  • the first pusher 132 is arranged to be displaceable in the axial direction.
  • the filling member 134 includes a head portion 148 that is liquid-tightly inserted into the hollow portion of the cylindrical body 130 on the tip side of the first pusher 132, and a first pusher that extends from the head portion 148 in the proximal direction.
  • the shaft portion 150 is inserted into the insertion hole 142 a of the shaft 142 of the 132.
  • the filling member 134 is not provided with the grip 45 (see FIG. 1 and the like) as provided in the filling member 134 in the first embodiment.
  • the head member 148 is provided with a seal member 152 on the outer peripheral portion in the same manner as the head member 42 in the first embodiment.
  • the seal member 152 is in close contact with the inner peripheral surface of the cylindrical body 130 and is slidable in a liquid-tight manner in the axial direction along the inner peripheral surface.
  • the shaft portion 150 is smaller in diameter than the shaft 142 of the first pusher 132, and is inserted into an insertion hole 142a provided in the shaft 142 so as to be slidable in the axial direction, and when the second pusher 136 is pulled. The axial force is received and transmitted to the head portion 148.
  • the total length of the shaft portion 150 is approximately the same as the total length of the shaft 142.
  • the filling member 134 is provided with a through hole 135 that penetrates the head portion 148 and the shaft portion 150 in the axial direction.
  • the through-hole 135 includes a large-diameter portion 135a that forms the distal end side of the through-hole 135 and a small-diameter portion 135b that forms the proximal end side of the through-hole 135.
  • the large-diameter portion 135a and the small-diameter portion 135b Is provided in the vicinity of the intermediate point of the filling member 134 in the axial direction.
  • the second pusher 136 is inserted through the through-hole 135 of the filling member 134 so as to be displaceable in the axial direction within a restricted range.
  • the second pusher 136 has a rod 156 slidably inserted into the through hole 135 of the filling member 134 and a flange portion 158 provided (attached) to the proximal end portion of the rod 156.
  • the rod 156 is formed with a smaller diameter than the shaft portion 150 of the filling member 134.
  • An axis of the rod 156 with respect to the first pusher 132 is disposed on the outer peripheral surface of a portion of the rod 156 that protrudes from the filling member 134 to the proximal end side with the second pusher 136 displaced to the most proximal side with respect to the filling member 134.
  • Scales indicating the position in the direction may be provided at regular intervals.
  • the scale is not particularly limited as long as it can be visually recognized by the user.
  • the scale may be constituted by a groove extending in the circumferential direction, or may be made of ink (paint) having a color different from that of the rod 156. It may be displayed.
  • the enlarged diameter portion 160 whose outer diameter is slightly larger than the other portions is formed on the distal end side of the rod 156.
  • a stepped portion 162 is formed by the outer diameter difference between the enlarged diameter portion 160 and a portion closer to the proximal end than the enlarged diameter portion 160 (hereinafter referred to as the narrow diameter portion 161).
  • the second pusher 136 is located with respect to the filling member 134 until the end surface (stepped portion 162) on the proximal end side of the enlarged diameter portion 160 and the stepped portion 154 provided on the inner peripheral portion of the filling member 134 are in contact with each other. Can be moved to the base end side.
  • a seal member 152 is attached to the outer peripheral portion of the enlarged diameter portion 160 of the rod 156.
  • the seal member 152 can slide in a liquid-tight manner in the axial direction along the inner peripheral surface while being in close contact with the inner peripheral surface of the shaft portion 150 of the filling member 134.
  • the seal member 152 is in the form of a ring provided on the outer peripheral portion of the enlarged diameter portion 160, but instead of this form, for example, an elastic member attached to the distal end of the enlarged diameter portion 160.
  • a gasket made of a resin material may be used.
  • the amount of medicine discharged by the second pusher 136 when the second pusher 136 is moved from the most proximal side to the most distal side with respect to the filling member 134 is, for example, 0.5 to Set to about 3 mL.
  • the outer diameter of the tip of the second pusher 136 is set to, for example, about 2 to 7 mm, and more preferably set to about 3 to 6 mm. If the outer diameter of the distal end portion of the second pusher 136 is too large, the operation force when pressing the second pusher 136 of the drug injection device 10D filled with the high-viscosity drug becomes too large, and the operation becomes difficult. It becomes difficult. If the outer diameter of the tip of the second pusher 136 is too small, the excluded volume (discharge amount) per unit movement amount in the axial direction is too small.
  • the flange portion 158 is a portion that the user hooks or presses with a finger when the second pusher 136 is pulled toward the proximal end or when the second pusher 136 is pressed toward the distal end. There is an appropriate size for easy operation.
  • the second pusher 136 can move with respect to the filling member 134 to a position where the distal end surface of the flange portion 158 and the proximal end surface of the filling member 134 come into contact with each other.
  • the foremost surface of the second pusher 136 substantially coincides with the foremost portion of the filling member 134.
  • the drug injecting device 10D is inserted into the cylindrical body 130 with the first pusher 132 and the filling member 134, and the cover member 140 and the guide member 138 are connected. Keep connected. In this case, the first pusher 132 is moved to the most proximal side of the movable range, and the filling member 134 is moved to the most distal side of the movable range.
  • the suction port 80 is screwed and attached to the lock portion 28 of the cylindrical body 130, and the tip of the suction port 80 is buried in the bone cement 86.
  • the suction port 80 may be attached to the cylindrical body 130 before the cover member 140 and the guide member 138 are connected.
  • the second pusher 136 is pulled in the proximal direction in a state where the distal end portion of the suction port 80 is buried in the bone cement 86. Then, since the second pusher 136 and the filling member 134 are engaged at the step portions 154 and 162 (see FIG. 12), the filling member 134 is pulled up with the movement of the second pusher 136. It is done. As the filling member 134 rises (retreats), the bone cement 86 is sucked into the cylindrical body 130 through the suction port 80 and the distal end tube portion 20. Thereby, the bone cement 86 is filled in the cylindrical body 130.
  • the filling amount of the bone cement 86 in the cylindrical body 130 is, for example, about 5 to 20 mL.
  • the distal end surface of the first pusher 132 becomes the head portion of the filling member 134.
  • the filling member 134 is pushed up (advanced) by the first pusher 132 in contact with the base end surface of 148. Then, as shown in FIG. 13C, the air is completely discharged from the cylindrical body 130 by moving the filling member 134 forward by an amount corresponding to the volume of air existing at the end of filling the bone cement 86. Can do.
  • the bone cement 86 filled in the drug injection device 10D is discharged and injected into the bone 90.
  • the first pusher 132 is rotated, and the filling member 134 is moved to the distal end side with respect to the cylindrical body 130. Then, as the filling member 134 moves toward the distal end side with respect to the tubular body 130, the filling chamber in the tubular body 130 is pressurized to a high pressure, and the bone cement 86 is moved to the distal end pipe portion 20, the extension tube 88, and the bone cement. It is injected into the bone 90 via the injection needle 92. In this case, since the second pusher 136 receives pressure from the bone cement 86 as the first pusher 132 is rotated, the second pusher 136 is brought to the proximal end side with respect to the first pusher 132. Moving.
  • the bone cement 86 can be injected with a relatively small operation force, and the head portion 148 of the filling member 134 is compared. Due to the large diameter, a relatively large amount of bone cement 86 can be injected quickly.
  • the injection amount of the bone cement 86 per rotation of the first pusher 132 may be set to a predetermined amount (for example, 0.25 to 2 mL).
  • the second pusher 136 is pushed and the first pusher 132 and It moves to the front end side with respect to the filling member 134. Then, as the second pusher 136 moves toward the distal end side with respect to the first pusher 132 and the filling member 134, the filling chamber in the cylindrical body 130 is pressurized to a high pressure, and the bone cement 86 is moved to the distal end pipe portion 20. The bone 90 is injected through the extension tube 88 and the bone cement injection needle 92. By pressing the second pusher 136, the bone cement 86 is injected up to the target injection amount.
  • the second pusher 136 Since the second pusher 136 has a smaller diameter than the head portion 148 of the filling member 134, a high pressure can be generated with a small operating force, and precise injection can be performed.
  • the maximum injection amount of the second pusher 136 may be set to a predetermined amount (for example, 0.5 to 3 mL).
  • the pressing operation on the second pusher 136 may be stopped. Then, the pressure in the system is reliably released by the second pusher 136 moving backward with respect to the first pusher 132 and the filling member 134 by the pushing force in the proximal direction from the bone cement 86.
  • the injection can be stopped suddenly and accurate injection can be guaranteed.
  • a second usage method (operation method) of the pharmaceutical injection device 10D will be described with reference to FIGS. 15A to 16B.
  • the second usage method as in the first usage method, first, the bone cement 86 is filled into the drug injection device 10D.
  • a stopcock 170 in the second usage method, it is preferable to use a stopcock 170 in order to prevent the bone cement 86 from being discharged by a rotation operation on the first pusher 132.
  • the stopcock 170 has a first port 172, a second port 174, and a cock 176. By rotating the cock 176, the passage between the first port 172 and the second port 174 communicates. It is configured as a two-way stopcock that can selectively switch between an open state and a closed state in which the passage between the first port 172 and the second port 174 is blocked.
  • Such a stopcock 170 may be provided at either the end of the extension tube 88 on the side connected to the bone cement injection needle 92 or the end on the side connected to the drug injection tool 10D. As shown in the above, when provided at the end of the side connected to the drug injection device 10D, the cock 176 of the stopcock 170 can be rotated outside the X-ray irradiation area when the bone cement 86 is injected. X-ray exposure can be preferably avoided.
  • the bone cement 86 filled in the drug injection device 10D is discharged and injected into the bone 90 under X-ray fluoroscopy.
  • the second pusher 136 is pressed to make the second pusher 136 cylindrical.
  • the body 130 is moved toward the tip side.
  • the filling chamber in the cylindrical body 130 is pressurized to a high pressure, and the bone cement 86 is moved to the distal end pipe portion 20.
  • the bone 90 is injected through the extension tube 88 and the bone cement injection needle 92. Since the second pusher 136 has a smaller diameter than the head portion 148 of the filling member 134, high pressure can be generated with a small operating force, and precise injection is possible.
  • the cock 176 is rotated to close the stopcock 170, and then the first pusher 132 is rotated to bring the first pusher 132 to the tip of the cylindrical body 130. Move to the side.
  • the second pusher 136 moves to the proximal end side with respect to the first pusher 132 and the filling member 134.
  • the bone cement 86 is prevented from being discharged from the drug injection tool 10D by the stopcock 170, the bone cement 86 is discharged from the drug injection tool 10D as the first pusher 132 is rotated. There is nothing.
  • the rotation operation with respect to the first pusher 132 is performed until the second pusher 136 is retracted to the most proximal position.
  • the second pusher 136 is pressed to inject the bone cement 86 into the bone 90. Thereafter, similarly to the case of FIG. 16A, the first pusher 132 is rotated again to return the second pusher 136 to the original position.
  • the second pusher 136 is rotated by rotating the first pusher 132 after performing an operation of injecting a small amount by pushing the second pusher 136 toward the distal end side.
  • the two operations are alternately repeated a plurality of times to inject a target amount of bone cement 86. Therefore, precise injection is possible in all injections.
  • the pressure increase in the tubular body 130 due to the pressing operation of the first pusher 132 is insufficient, and it is difficult to move the second pusher 136 backward to the base side. Therefore, it is preferable to use the stopcock 170.
  • the coupling structure of the guide member 36 (138) and the cover member 52 (140) is screw fitting, but is not limited to this, and other coupling structures, for example, a cover An engagement piece that protrudes outward is provided at the base end of the member 52 (140), and a groove portion that can be fitted to the engagement piece is provided in the guide member 36 (138), and the cover member 52 (140) and the guide are provided.
  • the guide member 36 (138) is fixed to the cylindrical body 12 (130) by coupling the cover member 52 (140) and the guide member 36 (138).
  • the configuration is not limited thereto, and a configuration in which the guide member 36 (138) is directly fixed to the cylindrical body 12 (130) may be employed.

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Abstract

A medical agent injection device (10A) is provided with a cylindrical body (12) which is filled with a medical agent, a plunger (14) which is inserted in the hollow section of the cylindrical body (12), and a filling member (16) which can be displaced in the axial direction relative to the plunger (14). The filling member (16) has a head section (42) which is inserted into the hollow section of the cylindrical body (12) in a liquid-tight manner at a position closer to the front end than the plunger (14). The medical agent is filled into the cylindrical body (12) by moving the filling member (16) backward relative to the cylindrical body (12), and the medical agent filled into the cylindrical body (12) is discharged from a medical agent discharge opening (12a) by rotating and moving the plunger (14) forward to move the head section (42) toward the front end.

Description

薬剤注入具Drug infusion tool
　本発明は、薬剤を被注入空間に注入する際に薬剤を吐出するために使用する薬剤注入具に関する。 The present invention relates to a drug injection device used for discharging a drug when the drug is injected into an injection space.
　近年、骨粗鬆症や癌による椎体圧迫骨折に対して、骨折椎体に刺入した骨生検針を通して時間と共に硬化する充填材を注入する経皮的椎体形成術（ＰＶＰ）が行われている。この充填材としては、例えば、Ｘ線造影性のあるリン酸カルシウム系骨セメントやポリメチルメタクリレート骨セメント等（以下、単に「骨セメント」ともいう）が用いられている。通常、骨セメントは非常に高い粘性を有しており、また骨セメントが充填される椎骨内は海綿質等により圧損が非常に大きいため、注入時には３ＭＰａ以上の高圧で少量ずつ注入する必要がある。 In recent years, percutaneous vertebroplasty (PVP) is performed for vertebral body compression fractures caused by osteoporosis or cancer by injecting a filling material that hardens with time through a bone biopsy needle inserted into the fractured vertebral body. As the filler, for example, calcium phosphate bone cement or polymethylmethacrylate bone cement (hereinafter, also simply referred to as “bone cement”) having X-ray contrast properties is used. Normally, bone cement has a very high viscosity, and the pressure loss due to the sponge is very large in the vertebra filled with the bone cement, so it is necessary to inject a small amount at a high pressure of 3 MPa or more at the time of injection. .
　このような注入を行うための薬剤注入具として、一般的なピストン式や送りネジ式のシリンジによって高圧を付与しながら骨セメントを吐出する構成が用いられている。送りネジ式の薬剤注入具は、例えば、特表２００４－５００９６３号公報に開示されている。 As a drug injection tool for performing such injection, a configuration is used in which bone cement is discharged while applying a high pressure by a general piston type or feed screw type syringe. A feed screw type drug injection device is disclosed in, for example, Japanese Patent Publication No. 2004-500963.
　ところで、使用者（術者）のＸ線被曝を抑えるため、生検針とシリンジの間に延長チューブを設け、シリンジから吐出した骨セメントを、当該延長チューブを介して骨内に注入するように構成された薬剤注入具が提案されている。しかし、高粘度の骨セメントを細長い延長チューブの内部に流すため圧力損失が大きく、シリンジ式の薬剤注入具では押圧操作に際して大きな操作力が必要となり注入が難しい。これに対し、送りネジ式の薬剤注入具では、延長チューブを用いた注入においても、比較的小さな操作力での回転操作により、高圧で比較的多くの量の注入が可能である。 By the way, in order to suppress the X-ray exposure of the user (operator), an extension tube is provided between the biopsy needle and the syringe, and the bone cement discharged from the syringe is injected into the bone through the extension tube. An improved drug infusion device has been proposed. However, since a highly viscous bone cement is allowed to flow inside the elongated elongated tube, the pressure loss is large, and a syringe-type drug injection device requires a large operating force during a pressing operation and is difficult to inject. On the other hand, in the feed screw type drug injection device, even in the injection using the extension tube, a relatively large amount of injection can be performed at a high pressure by a rotating operation with a relatively small operation force.
　送りネジ式の薬剤注入具は、一般に、薬剤を吐出するための吐出口を先端に有する筒状体と、筒状体に挿入される押し子とを備え、この押し子は外周に雄ネジが形成されたシャフトを有する。筒状体に挿入された押し子を回転操作すると、押し子は回転に伴って螺合作用により筒状体に対して前進することで、筒状体内に充填された骨セメントが、筒状体の先端の吐出口から吐出される。 A feed screw type drug injection device generally includes a cylindrical body having a discharge port for discharging a drug at its tip and a pusher inserted into the cylindrical body, and the pusher has a male screw on its outer periphery. Having a formed shaft. When the pusher inserted into the cylindrical body is rotated, the pusher moves forward with respect to the cylindrical body by a screwing action along with the rotation, so that the bone cement filled in the cylindrical body is replaced with the cylindrical body. It is discharged from the discharge port at the tip of the tube.
　このような構成の薬剤注入具の場合、筒状体内に骨セメントを充填する方法としては、次の方法がある。すなわち、筒状体から押し子を抜き取り、筒状体の基端開口を上方に向けた状態で、当該基端開口を介して骨セメントを流し入れ、次に、筒状体に押し子を挿入する、という方法である。 In the case of such a drug injection device, there are the following methods for filling bone cement into the cylindrical body. That is, the pusher is extracted from the cylindrical body, and bone cement is poured through the proximal end opening with the proximal end opening of the cylindrical body facing upward, and then the pusher is inserted into the cylindrical body. This is the method.
　しかしながら、上記の充填方法では、筒状体からの押し子の取外し、筒状体への押し子の装着を行う必要があり、骨セメントの充填作業が煩雑である。 However, in the above filling method, it is necessary to remove the pusher from the tubular body and to attach the pusher to the tubular body, and the work of filling the bone cement is complicated.
　本発明はこのような課題を考慮してなされたものであり、筒状体内への薬剤の充填を簡易に行うことができる薬剤注入具を提供することを目的とする。 The present invention has been made in view of such problems, and an object of the present invention is to provide a drug injection device that can easily fill a cylindrical body with a drug.
　上記の目的を達成するため、本発明は、内部に充填された薬剤を吐出する薬剤注入具であって、先端に薬剤吐出口を有し、前記薬剤が充填される筒状体と、前記筒状体の中空部に挿入され、軸線方向に貫通する挿通孔を有する押し子と、前記押し子の前記筒状体に対する回転に伴って前記押し子を前記筒状体に対して軸線方向に変位させる送りネジ構造と、前記押し子よりも先端側で前記筒状体の中空部に液密に挿入されるヘッド部を有し、前記押し子に対して軸線方向に変位可能な充填部材と、を備え、前記充填部材を前記筒状体に対して後退させることにより、前記筒状体内への前記薬剤の充填を行い、前記押し子を回転操作して前進させて前記ヘッド部を先端方向に移動させることにより、前記筒状体内に充填された前記薬剤を前記薬剤吐出口から吐出することを特徴とする。 In order to achieve the above object, the present invention provides a drug injection device for discharging a drug filled inside, a cylindrical body having a drug discharge port at a tip and filled with the drug, and the cylinder A pusher inserted into the hollow portion of the cylindrical body and having an insertion hole penetrating in the axial direction, and the pusher is displaced in the axial direction with respect to the cylindrical body as the pusher rotates relative to the cylindrical body. A feed screw structure that has a head portion that is liquid-tightly inserted into the hollow portion of the cylindrical body on the tip side of the pusher, and a filling member that can be displaced in the axial direction with respect to the pusher; The medicine is filled into the tubular body by retracting the filling member with respect to the tubular body, and the pusher is rotated and advanced to move the head portion in the distal direction. By moving, the medicine filled in the cylindrical body is Characterized by discharging the agent ejection port.
　上記の構成によれば、薬剤注入具の先端を、容器等に収容された薬剤内に入れ、充填部材を筒状体に対して後退させると、充填部材の後退に伴って、薬剤が筒状体の薬剤吐出口を介して筒状体内へと吸引される。従って、薬剤注入具の筒状体内に薬剤を簡易に充填することができる。 According to said structure, when the front-end | tip of a chemical | medical agent injection tool is put in the chemical | medical agent accommodated in the container etc. and a filling member is retracted | retreated with respect to a cylindrical body, a chemical | medical agent will be cylindrical as the filling member retracts. It is sucked into the cylindrical body through the body's drug discharge port. Accordingly, the drug can be easily filled into the cylindrical body of the drug injection tool.
　上記の薬剤注入具において、前記押し子の先端部は先細り形状となっているとよい。 In the above-described drug injection device, it is preferable that the tip of the pusher has a tapered shape.
　上記の構成によれば、押し子の先端部とヘッド部の基端面との接触面積を小さくすることで、接触部分での摩擦抵抗を低減させ、押し子の回転操作に要する操作力を低減できる。よって、操作性を向上できる。 According to said structure, by reducing the contact area of the front-end | tip part of a pusher and the base end surface of a head part, the frictional resistance in a contact part can be reduced and the operation force required for rotation operation of a pusher can be reduced. . Therefore, operability can be improved.
　上記の薬剤注入具において、前記押し子は、前記筒状体に挿通されるシャフトを有し、前記充填部材は、前記ヘッド部から基端方向に延出して前記シャフトの中空部に挿通された軸部を有し、前記軸部は、軸線方向の途中位置で先端側の第１部位と基端側の第２部位とに分離可能であるとよい。 In the medicine injection tool, the pusher includes a shaft that is inserted into the cylindrical body, and the filling member extends from the head portion in the proximal direction and is inserted into a hollow portion of the shaft. It has a shaft part, and the shaft part may be separable into a first part on the distal end side and a second part on the proximal end side at a midway position in the axial direction.
　上記の構成によれば、薬剤を筒状体内に充填した後に、第１部位から第２部位を分離すると、押し子を回転操作する際に充填部材が邪魔にならないため、操作性に優れる。 According to the above configuration, if the second part is separated from the first part after filling the cylindrical body with the medicine, the filling member does not get in the way when the pusher is rotated, so that the operability is excellent.
　上記の薬剤注入具において、前記軸部は、軸線方向の前記途中位置に脆弱部を有し、前記第１部位と前記第２部位とは、前記軸部に所定以上の曲げ応力が作用した際に前記脆弱部が破断することにより分離可能となっているとよい。 In the medicine injection tool, the shaft portion has a fragile portion at the intermediate position in the axial direction, and the first portion and the second portion are when a bending stress of a predetermined level or more acts on the shaft portion. In addition, it is preferable that the fragile portion can be separated by breaking.
　上記の構成によれば、第１部位と第２部位とを一体の部品として形成できることから、複数部分に分離可能な軸部を少ない部品点数で構成できる。 According to the above configuration, since the first part and the second part can be formed as an integral part, the shaft part separable into a plurality of parts can be configured with a small number of parts.
　上記の薬剤注入具において、前記押し子は、前記シャフトの基端に設けられたハンドルを有し、前記ハンドルには、前記充填部材の前記軸部が進入可能な溝部が設けられるとよい。 In the above drug infusion device, the pusher has a handle provided on the proximal end of the shaft, the handle, the shaft portion of the filling member may groove that can enter is provided.
　上記の構成によれば、充填部材を折り曲げて分離させる際に、その軸部がハンドルに設けられた溝部に進入するため、充填部材の軸部を折る操作を容易に実施できる。 According to the above configuration, when the filling member is folded and separated, the shaft portion enters the groove portion provided in the handle, so that the operation of folding the filling member shaft portion can be easily performed.
　上記の薬剤注入具において、前記充填部材は、前記軸部の基端に設けられた把持部を有し、前記把持部の側部には、有底の凹部が設けられるとよい。 In the above-described drug injection device, the filling member may include a grip portion provided at a proximal end of the shaft portion, and a bottomed recess may be provided in a side portion of the grip portion.
　上記の構成によれば、把持部の側方から凹部を押圧することにより、充填部材の軸部を折る操作を容易に実施することができる。 According to the above configuration, the operation of folding the shaft portion of the filling member can be easily performed by pressing the concave portion from the side of the grip portion.
　上記の薬剤注入具において、前記充填部材は、軸線方向に沿って前記ヘッド部の先端面まで延在するエア排出路を有し、前記第２部位が前記第１部位から分離した際、前記エア排出路を介して、前記筒状体内と外気とが連通してもよい。 In the above-described drug injection device, the filling member has an air discharge path extending to an end surface of the head portion along the axial direction, and when the second portion is separated from the first portion, the air The cylindrical body and the outside air may communicate with each other via the discharge path.
　上記の構成によれば、薬剤を筒状体内に充填した後に行うエア排出作業において、充填部材の軸部を分離した状態で充填部材を前進させることにより、筒状体を上方に向けなくても、筒状体内のエアを容易且つ確実に外部へと排出することができる。 According to the above configuration, in the air discharge operation performed after the medicine is filled in the cylindrical body, the cylindrical body does not face upward by moving the filling member forward with the shaft portion of the filling member separated. The air in the cylindrical body can be easily and reliably discharged to the outside.
　上記の薬剤注入具において、前記軸部には、外方に突出した第１凸部が設けられ、前記シャフトには、内方に突出し且つ前記第１凸部と係合可能な第２凸部が設けられ、前記充填部材に所定以上の軸力が作用したとき、前記第１凸部が前記第２凸部を乗り越えることが可能であり、前記押し子に対して前記充填部材を後退させる際において、前記第１凸部と前記第２凸部とが接触した時点で、前記脆弱部が前記シャフトの基端から外部に露出してもよい。 In the above drug infusion device, the shaft portion, the first protrusion is provided protruding outward, to the shaft, protrudes inwardly and the first convex portion engageable with the second protrusion When the axial force of a predetermined level or more acts on the filling member, the first convex portion can get over the second convex portion, and when the filling member is retracted with respect to the pusher The weak portion may be exposed to the outside from the base end of the shaft when the first convex portion and the second convex portion contact each other.
　上記の構成によれば、薬剤を筒状体内に充填する作業において、第１凸部と第２凸部とが接触することにより、充填部材の移動抵抗が増大する。そしてこの位置では、軸部に設けられた脆弱部は、押し子のシャフトの基端から外部に露出した位置にある。従って、軸部の切断可能位置を使用者に認識させ易い。また、注入を急停止させたい場合には押し子を逆回転させればよく、この場合、第１凸部と第２凸部との係合作用により、必要以上に押し子を逆回転させることがない。 According to the above configuration, the movement resistance of the filling member is increased by the contact between the first convex portion and the second convex portion in the operation of filling the cylindrical body with the medicine. And in this position, the weak part provided in the axial part exists in the position exposed outside from the base end of the shaft of a pusher. Therefore, it is easy for the user to recognize the position where the shaft portion can be cut. In addition, if it is desired to stop the injection suddenly, the pusher may be reversely rotated. In this case, the pusher is reversely rotated more than necessary by the engagement action of the first convex portion and the second convex portion. There is no.
　上記の薬剤注入具において、前記押し子は、第１押し子であり、前記充填部材は、軸線方向に貫通する貫通孔を有し、前記薬剤注入具は、さらに、前記貫通孔に軸線方向に液密に摺動可能に挿通された第２押し子を備えてもよい。 In the above-described drug injection device, the pusher is a first pusher, the filling member has a through-hole penetrating in the axial direction, and the drug injection device is further inserted in the through-hole in the axial direction. A second pusher inserted so as to be slidable in a liquid-tight manner may be provided.
　上記の構成によれば、第２押し子を用いて少量の薬剤を吐出することにより、精密な注入が可能である。 According to the above configuration, precise injection is possible by discharging a small amount of medicine using the second pusher.
本発明の第１実施形態に係る薬剤注入具の分解斜視図である。It is an exploded perspective view of the medicine injection device concerning a 1st embodiment of the present invention. 図１に示す薬剤注入具の組立状態での縦断面図である。It is a longitudinal cross-sectional view in the assembly state of the chemical injection tool shown in FIG. 図３Ａは、図１に示す薬剤注入具に薬剤を充填する方法を説明する第１の図であり、図３Ｂは、図１に示す薬剤注入具に薬剤を充填する方法を説明する第２の図である。FIG. 3A is a first diagram illustrating a method of filling a medicine injection device shown in FIG. 1 with a drug, and FIG. 3B is a second diagram illustrating a method of filling the medicine injection device shown in FIG. FIG. 図４Ａは、図１に示す薬剤注入具の筒状体内からエアを排出する方法を説明する第１の図であり、図４Ｂは、図１に示す薬剤注入具の筒状体内からエアを排出する方法を説明する第２の図である。4A is a first diagram for explaining a method of discharging air from the cylindrical body of the drug injection device shown in FIG. 1, and FIG. 4B is a diagram illustrating discharging air from the cylindrical body of the drug injection device shown in FIG. It is the 2nd figure explaining the method to do. 図１に示す薬剤注入具の充填部材の一部を分離した状態を示す図である。It is a figure which shows the state which isolate | separated a part of filling member of the chemical injection tool shown in FIG. 図６Ａは、図１に示す薬剤注入具の操作方法を説明する第１の図であり、図６Ｂは、図１に示す薬剤注入具の操作方法を説明する第２の図である。6A is a first diagram illustrating an operation method of the drug injection device illustrated in FIG. 1, and FIG. 6B is a second diagram illustrating an operation method of the drug injection device illustrated in FIG. 1. 本発明の第２実施形態に係る薬剤注入具の縦断面図である。It is a longitudinal cross-sectional view of the chemical injection tool which concerns on 2nd Embodiment of this invention. 図８Ａは、図７に示す薬剤注入具に薬剤を充填する方法を説明する第１の図であり、図８Ｂは、図７に示す薬剤注入具に薬剤を充填する方法を説明する第２の図である。8A is a first diagram illustrating a method of filling a drug in drug infusion device shown in FIG. 7, FIG. 8B, the second describing the method of filling a drug in drug infusion device shown in FIG. 7 FIG. 図９Ａは、図７に示す薬剤注入具の筒状体内からエアを排出する方法を説明する第１の図であり、図９Ｂは、図７に示す薬剤注入具の筒状体内からエアを排出する方法を説明する第２の図である。9A is a first view for explaining a method of discharging air from the cylindrical body of the drug injection device shown in FIG. 7, and FIG. 9B discharges air from the cylindrical body of the drug injection device shown in FIG. It is the 2nd figure explaining the method to do. 本発明の第３実施形態に係る薬剤注入具の縦断面図である。It is a longitudinal cross-sectional view of the chemical injection tool which concerns on 3rd Embodiment of this invention. 図１１Ａは、図１０に示す薬剤注入具の作用を説明する第１の図であり、図１１Ｂは、図１０に示す薬剤注入具の作用を説明する第２の図である。FIG. 11A is a first diagram for explaining the operation of the drug injection device shown in FIG. 10, and FIG. 11B is a second diagram for explaining the operation of the drug injection device shown in FIG. 本発明の第４実施形態に係る薬剤注入具の縦断面図である。It is a longitudinal cross-sectional view of the chemical injection tool which concerns on 4th Embodiment of this invention. 図１３Ａは、図１２に示す薬剤注入具に薬剤を充填する方法を説明する第１の図であり、図１３Ｂは、図１２に示す薬剤注入具に薬剤を充填する方法を説明する第２の図であり、図１３Ｃは、図１２に示す薬剤注入具の筒状体内からエアを排出する方法を説明する図である。13A is a first diagram illustrating a method for filling a drug injecting device shown in FIG. 12, and FIG. 13B is a second diagram illustrating a method for filling the drug injecting device shown in FIG. FIG. 13C is a view for explaining a method of discharging air from the cylindrical body of the pharmaceutical injection device shown in FIG. 図１４Ａは、図１２に示す薬剤注入具の第１の操作方法を説明する第１の図であり、図１４Ｂは、図１２に示す薬剤注入具の第１の操作方法を説明する第２の図である。14A is a first diagram illustrating a first operation method of the drug injection device shown in FIG. 12, and FIG. 14B is a second diagram illustrating a first operation method of the drug injection device shown in FIG. FIG. 図１５Ａは、図１２に示す薬剤注入具の第２の操作方法を説明する第１の図であり、図１５Ｂは、図１２に示す薬剤注入具の第２の操作方法を説明する第２の図である。15A is a first diagram illustrating a second method of operation of the infusion device shown in FIG. 12, FIG. 15B, the second describing the second method of operation of the infusion device shown in FIG. 12 FIG. 図１６Ａは、図１２に示す薬剤注入具の第２の操作方法を説明する第３の図であり、図１６Ｂは、図１２に示す薬剤注入具の第２の操作方法を説明する第４の図である。16A is a third diagram illustrating a second method of operation of the infusion device shown in FIG. 12, FIG. 16B, the fourth explaining a second method of operation of the infusion device shown in FIG. 12 FIG.
　以下、本発明に係る薬剤注入具について好適な実施形態を挙げ、添付の図面を参照しながら説明する。 Hereinafter, preferred embodiments of the drug injection device according to the present invention will be described with reference to the accompanying drawings.
［第１実施形態］
　図１は、本発明の第１実施形態に係る薬剤注入具１０Ａを示す分解斜視図である。図２は、図１に示した薬剤注入具１０の組立状態での縦断面図である。薬剤注入具１０は、薬剤（充填材、注入材）を所望の被注入空間に注入する際に薬剤を吐出するために使用する医療機器であり、例えば、経皮的椎体形成術において骨セメントを骨内に注入するために用いられる。 [First Embodiment]
FIG. 1 is an exploded perspective view showing a pharmaceutical injection device 10A according to the first embodiment of the present invention. FIG. 2 is a longitudinal sectional view of the pharmaceutical injection device 10 shown in FIG. 1 in an assembled state. The drug injection tool 10 is a medical device used for discharging a drug when a drug (filler, injection material) is injected into a desired injection space. For example, bone cement in percutaneous vertebroplasty. Is used to inject into the bone.
　薬剤注入具１０に充填される薬剤としては、例えば、リン酸カルシウム系骨セメント（ＣＰＣ）やポリメチルメタクリレート（ＰＭＭＡ）系骨セメント等の骨セメントを用いることができ、さらには、リン酸カルシウム系セラミックス、アルミナセラミックス、ジルコニアセラミックス及びチタン等の無機材料からなる顆粒等を用いることもできる。 As the medicine filled in the medicine injection tool 10, for example, bone cement such as calcium phosphate bone cement (CPC) or polymethyl methacrylate (PMMA) bone cement can be used, and further, calcium phosphate ceramics and alumina ceramics. Granules made of inorganic materials such as zirconia ceramics and titanium can also be used.
　図１及び図２に示すように、薬剤注入具１０は、薬剤が充填される筒状体１２と、筒状体１２の中空部に挿入される押し子１４と、押し子１４に進退自在に挿通された充填部材１６とを備える。 As shown in FIGS. 1 and 2, the drug injection device 10 includes a cylindrical body 12 that is filled with a drug, a pusher 14 that is inserted into a hollow portion of the cylindrical body 12, and a pusher 14 that can advance and retract. And a filling member 16 inserted therethrough.
　筒状体１２は、軸線方向に延在する内腔（中空部）を有する胴体部１８と、胴体部１８の先端部から先端側に突出する先端管部２０と、胴体部１８の基端部から外方（半径方向外方）に突出し且つ周方向に延在する環状のフランジ部２２とを有する。筒状体１２の内部には、筒状体１２及び充填部材１６によって囲まれた空間により、薬剤を充填するための充填室が形成される。筒状体１２の先端には、薬剤吐出口１２ａが設けられ、筒状体１２の基端には、基端開口１２ｂが設けられる。胴体部１８、先端管部２０及びフランジ部２２は、一体的に形成されている。 The cylindrical body 12 includes a body portion 18 having a lumen (hollow portion) extending in the axial direction, a distal end tube portion 20 protruding from the distal end portion of the body portion 18 toward the distal end side, and a proximal end portion of the body portion 18. And an annular flange portion 22 projecting outward (radially outward) and extending in the circumferential direction. Inside the cylindrical body 12, a filling chamber for filling a medicine is formed by a space surrounded by the cylindrical body 12 and the filling member 16. A drug discharge port 12 a is provided at the distal end of the cylindrical body 12, and a proximal end opening 12 b is provided at the proximal end of the cylindrical body 12. The body part 18, the distal end pipe part 20, and the flange part 22 are integrally formed.
　胴体部１８は、内径一定の平行部１８ａと、平行部１８ａの先端から先端管部２０に向かって縮径するテーパ部１８ｂとからなり、全体として、中空円筒状に形成される。胴体部１８の外周面には、薬剤の量を示す目盛り１９が設けられる。 The body portion 18 includes a parallel portion 18a having a constant inner diameter and a tapered portion 18b that decreases in diameter from the tip of the parallel portion 18a toward the tip tube portion 20, and is formed in a hollow cylindrical shape as a whole. A scale 19 indicating the amount of the medicine is provided on the outer peripheral surface of the body portion 18.
　先端管部２０は、薬剤吐出口１２ａを形成するものであり、ルアーコネクタとして構成されている。先端管部２０の外側には、先端管部２０と同心状に胴体部１８の先端部から軸線方向に突出し、内周面に雌ネジ部２７が形成されたロック部２８が設けられている。このような先端管部２０とロック部２８により、薬剤を注入する際には、後述する延長チューブ８８又は骨セメント注入針９２（図６Ａ等参照）に連結可能である。 The distal end tube portion 20 forms the medicine discharge port 12a and is configured as a luer connector. On the outer side of the tip tube portion 20, a lock portion 28 that protrudes in the axial direction from the tip portion of the body portion 18 concentrically with the tip tube portion 20 and has an internal thread portion 27 formed on the inner peripheral surface is provided. When the medicine is injected by such a distal end pipe part 20 and the lock part 28, it can be connected to an extension tube 88 or a bone cement injection needle 92 (see FIG. 6A and the like) described later.
　図１に示すように、本実施形態において、フランジ部２２は非円形形状となっている。具体的には、フランジ部２２は、互いに平行な一対の直線部２２ａと、直線部の両端同士を繋ぐ一対の円弧部２２ｂとを有する。非円形形状のフランジ部２２は、図１に示す形状以外では、楕円形や多角形、あるいは、周方向の一部の範囲で外方に突出する形状等、カバー部材５２と係合し、空回りしない形状であればよい。 As shown in FIG. 1, in the present embodiment, the flange portion 22 has a non-circular shape. Specifically, the flange portion 22 includes a pair of straight portions 22a that are parallel to each other and a pair of arc portions 22b that connect both ends of the straight portions. Other than the shape shown in FIG. 1, the non-circular flange portion 22 engages with the cover member 52 such as an ellipse, a polygon, or a shape protruding outward in a part of the circumferential direction. Any shape can be used.
　筒状体１２の構成材料は、特に限定されないが、例えばポリプロピレン、ポリウレタン、ポリエチレン、環状ポリオレフィン、ポリメチルペンテン１等のポリオレフィンや、ポリエステル、ナイロン、ポリカーボネート、ポリメチルメタクリレート（ＰＭＭＡ）、ポリエーテルイミド（ＰＥＩ）、ポリエーテルサルホン、ポリエーテルエーテルケトン（ＰＥＥＫ）、フッ素樹脂、ポリフェニレンサルファイド（ＰＰＳ）、ポリアセタール樹脂（ＰＯＭ）等の樹脂性材料や、ステンレス等の金属性材料、ガラス等で形成されるとよい。また、筒状体１２の構成材料は、内部の視認性を確保するために、実質的に透明であるのが好ましい。また、高圧に耐えられる強度や弾性、耐薬品性があることが好ましい。 The constituent material of the cylindrical body 12 is not particularly limited. For example, polyolefin such as polypropylene, polyurethane, polyethylene, cyclic polyolefin, polymethylpentene 1, polyester, nylon, polycarbonate, polymethylmethacrylate (PMMA), polyetherimide ( PEI), polyethersulfone, polyetheretherketone (PEEK), fluororesin, polyphenylene sulfide (PPS), polyacetal resin (POM) and other resinous materials, stainless steel and other metallic materials, glass, etc. Good. Moreover, it is preferable that the constituent material of the cylindrical body 12 is substantially transparent in order to ensure internal visibility. Moreover, it is preferable that it has strength, elasticity and chemical resistance that can withstand high pressure.
　押し子１４は、筒状体１２の中空部に挿入可能なシャフト３０と、シャフト３０の基端に設けられ外方（半径方向外方）に拡径した中空状のハンドル３２とを有する。この押し子１４は、充填部材１６に対して軸線方向に変位可能且つ周方向に相対回転可能である。 The pusher 14 includes a shaft 30 that can be inserted into the hollow portion of the cylindrical body 12, and a hollow handle 32 that is provided at the base end of the shaft 30 and has an outward diameter (radially outward). The pusher 14 can be displaced in the axial direction relative to the filling member 16 and can be relatively rotated in the circumferential direction.
　シャフト３０は、軸線方向に直線状に貫通する挿通孔３０ａ（図２参照）を有する。シャフト３０の先端部を構成する頭部３１は、先端側に向かって縮径した先細り形状となっており、その最先端面は、小面積の環状先端面３１ａとなっている。環状先端面３１ａは、シャフト３０の軸線に対して垂直な面である。 The shaft 30 has an insertion hole 30a (see FIG. 2) penetrating linearly in the axial direction. Head 31 constituting the distal portion of the shaft 30, has a tapered shape that decreases in diameter toward the distal end side, the leading edge surface has a circular front end surface 31a of the small area. The annular tip surface 31 a is a surface perpendicular to the axis of the shaft 30.
　シャフト３０の外周部において長手方向の所定範囲には雄ネジ部３４が軸線方向に沿って形成されている。この雄ネジ部３４の外径は、筒状体１２の胴体部１８の内径よりも小さい。雄ネジ部３４には、カバー部材５２に連結可能なガイド部材３６が取り付けられる。ガイド部材３６の構成については後述する。 A male thread portion 34 is formed along the axial direction in a predetermined range in the longitudinal direction on the outer peripheral portion of the shaft 30. The outer diameter of the male screw portion 34 is smaller than the inner diameter of the body portion 18 of the cylindrical body 12. A guide member 36 that can be connected to the cover member 52 is attached to the male screw portion 34. The configuration of the guide member 36 will be described later.
　ハンドル３２は、押し子１４を筒状体１２に対して軸線を中心として回転させる際に使用者が手指で把持する（つまむ、握る）部分であり、本実施形態では、シャフト３０の基端から突出した充填部材１６を少なくとも部分的に覆うように基端方向に延在している。具体的には、ハンドル３２は、シャフト３０の基端部から半径方向外方に広がるフランジ部３２ａと、フランジ部３２ａの外端から基端方向に延出したカバー部３２ｂとを有する。使用者が把持して回転操作する際にすべりにくいように、カバー部３２ｂの外周には、周方向に間隔をおいて複数の溝が形成されてもよい。 The handle 32 is a portion that a user grips (pinch) with fingers when rotating the pusher 14 with respect to the cylindrical body 12 about the axis, and in this embodiment, from the proximal end of the shaft 30. It extends in the proximal direction so as to at least partially cover the protruding filling member 16. Specifically, the handle 32 includes a flange portion 32a extending radially outward from the proximal end portion of the shaft 30, and a cover portion 32b extending in the proximal direction from the outer end of the flange portion 32a. A plurality of grooves may be formed on the outer periphery of the cover portion 32b at intervals in the circumferential direction so that the user does not slip when gripping and rotating.
　ハンドル３２（具体的には、カバー部３２ｂ）には、シャフト３０の軸線方向に沿って延在し且つ当該ハンドル３２の基端方向に開放された切欠部３８が設けられている。本実施形態において、切欠部３８は、シャフト３０の中心（軸線）を基準とした対称位置（１８０度位相がずれた位置）に２つ設けられている。充填部材１６を押し子１４に対して基端方向に移動させる操作を実施する際に充填部材１６に対する引張り操作をし易いように、切欠部３８は、使用者の指が挿入できる程度の大きさに形成されるのがよい。 The handle 32 (specifically, the cover portion 32b) is provided with a cutout portion 38 that extends along the axial direction of the shaft 30 and is opened in the proximal direction of the handle 32. In the present embodiment, two notches 38 are provided at symmetrical positions (positions where the phase is shifted by 180 degrees) with respect to the center (axis) of the shaft 30. In order to facilitate the pulling operation on the filling member 16 when the operation of moving the filling member 16 in the proximal direction with respect to the pusher 14 is performed, the notch 38 is large enough to allow the user's finger to be inserted. It is good to be formed.
　ハンドル３２において、切欠部３８の先端側には、充填部材１６の軸部４４が進入可能な溝部４０が設けられる。具体的には、この溝部４０は、カバー部３２ｂの内外を連通し且つカバー部３２ｂの基端方向に開口した形状となっている。溝部４０の幅は、充填部材１６の軸部４４の太さ（外径）よりも大きい。押し子１４の軸線方向に関して、溝部４０の先端位置は、シャフト３０の最基端部の近傍にあるのがよい。この構成により、軸部４４を折り曲げて脆弱部４８の箇所で破断させる際に、軸部４４を溝部４０に進入させることで、軸部４４を大きく折り曲げることができ、分離操作が容易である。 In the handle 32, a groove portion 40 into which the shaft portion 44 of the filling member 16 can enter is provided on the distal end side of the notch portion 38. Specifically, the groove portion 40 has a shape that communicates the inside and outside of the cover portion 32b and opens in the proximal direction of the cover portion 32b. The width of the groove portion 40 is larger than the thickness (outer diameter) of the shaft portion 44 of the filling member 16. With respect to the axial direction of the pusher 14, the distal end position of the groove portion 40 may be in the vicinity of the most proximal end portion of the shaft 30. With this configuration, when the shaft portion 44 is bent and broken at the weakened portion 48, the shaft portion 44 can be greatly bent by entering the groove portion 40, and the separation operation is easy.
　押し子１４の構成材料としては、上述した筒状体１２の構成材料として例示したものから選択することができる。 The constituent material of the pusher 14 can be selected from those exemplified as the constituent material of the cylindrical body 12 described above.
　充填部材１６は、薬剤吐出口１２ａを介して筒状体１２内に薬剤を充填する際に基端方向に移動操作されることにより、薬剤を筒状体１２内に吸引するためのデバイスであり、押し子１４に対して軸線方向に変位可能に配置される。この充填部材１６は、押し子１４よりも先端側で筒状体１２の中空部に液密に挿入されるヘッド部４２と、ヘッド部４２から基端方向に延出して押し子１４に設けられた挿通孔３０ａに挿通された軸部４４と、この軸部４４の基端に設けられた把持部４５とを有する。 Filling member 16, by being operated to move proximally when filling the drug through the drug discharge port 12a the cylindrical body 12, be a device for sucking the drug into the cylindrical body 12 The pusher 14 is disposed so as to be displaceable in the axial direction. The filling member 16 includes a head portion 42 which is inserted in a liquid-tight manner to the hollow portion of the cylindrical body 12 at the distal end side of the pusher 14, provided on the pushers 14 extends from the head portion 42 in the proximal direction The shaft portion 44 is inserted into the insertion hole 30a, and the grip portion 45 is provided at the base end of the shaft portion 44.
　ヘッド部４２は、充填部材１６の先端部を構成する部分であり、筒状体１２内で、筒状体１２のテーパ部１８ｂと、押し子１４の頭部３１とによって規制された範囲内で軸線方向に移動可能である。ヘッド部４２には、シール部材４６が装着される。図示例では、周方向に延在する環状のシール溝４７（図２参照）がヘッド部４２の外周に形成され、シール溝４７にリング状のシール部材４６（例えば、シリコーン製のＯリング等）が配置される。このようなシール部材４６が筒状体１２の内周面に密着しつつ軸線方向に摺動することで、液密性を確実に保持するとともに、摺動性の向上を図れる。 The head portion 42 is a portion that constitutes the distal end portion of the filling member 16, and is within the range restricted by the tapered portion 18 b of the cylindrical body 12 and the head portion 31 of the pusher 14 in the cylindrical body 12. It can move in the axial direction. A seal member 46 is attached to the head portion 42. In the illustrated example, an annular seal groove 47 (see FIG. 2) extending in the circumferential direction is formed on the outer periphery of the head portion 42, and a ring-shaped seal member 46 (for example, a silicone O-ring) is formed in the seal groove 47. Is placed. Such a seal member 46 slides in the axial direction while being in close contact with the inner peripheral surface of the cylindrical body 12, so that liquid-tightness can be reliably maintained and slidability can be improved.
　シール部材４６の構成材料としては、特に限定されないが、例えばオレフィン系エラストマーや、スチレン系エラストマー、ポリエステルエラストマー、ポリウレタンエラストマー、シリコーンゴム、ブチルゴム、フッ素ゴム等の加硫ゴム、さらにそれらにフッ素樹脂コートしたもの等で形成されるとよい。なお、リング状のシール部材４６の代わりに、充填部材１６の先端部に弾性樹脂材料で構成されたガスケットが取り付けられてもよい。 The constituent material of the seal member 46 is not particularly limited. For example, olefin elastomers, styrene elastomers, polyester elastomers, polyurethane elastomers, vulcanized rubbers such as silicone rubber, butyl rubber, and fluorine rubber, and further, fluororesin coated thereon. It is good to form with things. Instead of the ring-shaped seal member 46, a gasket made of an elastic resin material may be attached to the tip of the filling member 16.
　充填部材１６の先端部の外径（図示例の場合、ヘッド部４２に組み立てられた状態のシール部材４６の外径）は、筒状体１２の胴体部１８の内径と同じか僅かに小さく、例えば、５～５０ｍｍ程度に設定され、１０～２０ｍｍ程度に設定されるのがより好ましい。ヘッド部４２に組み立てられた状態のシール部材４６の外径が大き過ぎると、高粘度の薬剤が充填された薬剤注入具１０Ａの押し子１４を回転操作する際の操作力が大きくなり過ぎて、操作が難しくなる。また、ヘッド部４２に組み立てられた状態のシール部材４６の外径が小さすぎると、筒状体１２の胴体部１８との液密性を保持することが難しくなる。 The outer diameter of the front end portion of the filling member 16 (in the illustrated example, the outer diameter of the seal member 46 assembled in the head portion 42) is the same as or slightly smaller than the inner diameter of the body portion 18 of the cylindrical body 12, For example, it is set to about 5 to 50 mm, and more preferably set to about 10 to 20 mm. If the outer diameter of the seal member 46 assembled in the head portion 42 is too large, the operation force when rotating the pusher 14 of the drug injection device 10A filled with a high-viscosity drug becomes too large, Operation becomes difficult. In addition, if the outer diameter of the seal member 46 assembled in the head portion 42 is too small, it becomes difficult to maintain liquid tightness with the body portion 18 of the cylindrical body 12.
　軸部４４は、押し子１４のシャフト３０に設けられた挿通孔３０ａよりも小径であり、挿通孔３０ａ内に軸線方向に摺動可能に挿通され、使用者が把持部４５を把持して吸引操作をしたときの力、すなわち把持部４５に入力された使用者からの軸線方向の操作力を、上述したヘッド部４２に伝達するものである。筒状体１２内に摺動可能に挿入されたヘッド部４２を軸線方向に移動させるため、軸部４４の全長は、押し子１４のシャフト３０の全長よりも長い。 The shaft portion 44 is smaller in diameter than the insertion hole 30a provided in the shaft 30 of the pusher 14, and is inserted into the insertion hole 30a so as to be slidable in the axial direction. The user grips the gripping portion 45 and sucks it. The force when the operation is performed, that is, the operation force in the axial direction from the user input to the grip portion 45 is transmitted to the head portion 42 described above. Since the head portion 42 slidably inserted into the cylindrical body 12 is moved in the axial direction, the total length of the shaft portion 44 is longer than the total length of the shaft 30 of the pusher 14.
　本実施形態において、軸部４４は、軸線方向の途中位置で先端側の第１部位４４Ａと基端側の第２部位４４Ｂとに分離可能である。具体的には、軸部４４は、軸線方向の途中位置に脆弱部４８（図２参照）を有する。脆弱部４８は、断面Ｖ字状の環状溝である。すなわち、脆弱部４８は、断面Ｖ字状の環状溝によりその他の部分よりも細径に形成されることで、その他の部分よりも相対的に強度が小さくされた部分である。そのため、第１部位４４Ａと第２部位４４Ｂとは、軸部４４に所定以上の曲げ応力が作用した際に脆弱部４８が破断することにより分離可能となっている。 In the present embodiment, the shaft portion 44 can be separated into a first portion 44A on the distal end side and a second portion 44B on the proximal end side at an intermediate position in the axial direction. Specifically, the shaft portion 44 has a fragile portion 48 (see FIG. 2) at an intermediate position in the axial direction. The fragile portion 48 is an annular groove having a V-shaped cross section. That is, the weakened part 48 is a part whose strength is relatively smaller than that of the other part by being formed with a narrower diameter than the other part by the annular groove having a V-shaped cross section. Therefore, the first portion 44 </ b> A and the second portion 44 </ b> B can be separated by the fragile portion 48 being broken when a predetermined bending stress or more is applied to the shaft portion 44.
　後述するように、薬剤注入具１０の使用において、筒状体１２内に薬剤を充填し且つ筒状体１２内のエアの排出作業が完了した後に、脆弱部４８の位置で第２部位４４Ｂを第１部位４４Ａから分離させる。エア排出作業の終了時点での充填部材１６は、その可動範囲の最後退位置にあるのではなく、最後退位置よりもある程度先端側に進出した位置にある。また、エア排出作業の終了時点での充填部材１６の位置は、筒状体１２内への薬剤の充填量にもよる。一方、軸部４４に曲げ応力を作用させて、軸部４４を脆弱部４８の箇所で破断させるためには、脆弱部４８が外部に露出していることが必要である。 As will be described later, in the use of the drug injection device 10, after filling the cylindrical body 12 with the drug and completing the discharge operation of the air in the cylindrical body 12, the second portion 44 </ b> B is moved at the position of the fragile portion 48. Separated from the first portion 44A. The filling member 16 at the end of the air discharge operation is not located at the last retracted position of the movable range, but is located at a position where it has advanced to the tip side to some extent from the last retracted position. Further, the position of the filling member 16 at the end of the air discharge operation depends on the amount of medicine filled in the cylindrical body 12. On the other hand, in order to cause a bending stress to act on the shaft portion 44 and break the shaft portion 44 at the weakened portion 48, the weakened portion 48 needs to be exposed to the outside.
　そこで、充填部材１６が可動範囲の最も後退した位置よりもある程度先端側に寄った位置にある状態で、脆弱部４８が押し子１４のシャフト３０よりも基端側に位置するように（シャフト３０の後方で露出するように）、脆弱部４８の位置が設定される。これにより、筒状体１２内への薬剤の充填作業及びエア排出作業が終了した後に、軸部４４に対して所定以上の曲げ応力を作用させることで、脆弱部４８の箇所で軸部４４を破断させることができる。 Therefore, in a state where the filling member 16 is located at a position closer to the distal end side than the most retracted position of the movable range, the fragile portion 48 is positioned closer to the proximal end side than the shaft 30 of the pusher 14 (shaft 30 The position of the fragile portion 48 is set so that it is exposed behind. Thereby, after the filling operation of the medicine into the cylindrical body 12 and the air discharging operation are finished, the shaft portion 44 is moved at the position of the fragile portion 48 by applying a predetermined bending stress to the shaft portion 44. Can be broken.
　なお、第１部位４４Ａと第２部位４４Ｂとを分離可能にする構造は、上述した脆弱部４８による構成に限られない。例えば、別々の部品から構成された第１部位４４Ａと第２部位４４Ｂとが嵌合、螺合等の物理的係合により連結され、所定以上の引っ張り応力、曲げ応力又は回転応力が作用した際に、第１部位４４Ａと第２部位４４Ｂとの連結が解除される構成も採用され得る。 In addition, the structure which makes it possible to separate the first part 44A and the second part 44B is not limited to the configuration by the fragile portion 48 described above. For example, when the first part 44A and the second part 44B made of different parts are connected by physical engagement such as fitting and screwing, and a tensile stress, bending stress or rotational stress exceeding a predetermined level is applied. In addition, a configuration in which the connection between the first portion 44A and the second portion 44B is released may be employed.
　把持部４５は、筒状体１２内に薬剤を充填する際に、使用者が把持して（摘んで）引っ張り操作する部分であり、本実施形態では軸部４４よりも幅広な扁平形状に形成されている。図１に示すように、把持部４５の側部には、有底の凹部５０が設けられる。凹部５０は、把持部４５の両面に設けられる。なお、凹部５０は、把持部４５の片側面のみに設けられてもよい。このような凹部５０が設けられることにより、軸部４４を脆弱部４８の箇所で破断させる際に、把持部４５の側方から凹部５０を押圧すると、軸部４４に曲げ応力を容易に作用させることができるため、軸部４４の破断操作を容易に実施することができる。 The grip portion 45 is a portion that is gripped (pulled) and pulled by the user when filling the cylindrical body 12 with a medicine, and is formed in a flat shape wider than the shaft portion 44 in this embodiment. Has been. As shown in FIG. 1, a bottomed recess 50 is provided on the side of the grip 45. The concave portions 50 are provided on both surfaces of the grip portion 45. The concave portion 50 may be provided only on one side surface of the grip portion 45. By providing such a recess 50, when the shaft portion 44 is broken at the weakened portion 48, if the recess 50 is pressed from the side of the grip portion 45, bending stress is easily applied to the shaft portion 44. Therefore, the breaking operation of the shaft portion 44 can be easily performed.
　なお、把持部４５の形状は、骨セメントを充填する際は、基端方向へ引っ張ることができ、軸部４４を破断させる際は、径方向に押圧することができる形状であればよく、例えば、側部に貫通孔を設けた形状でもよい。また貫通孔を設けることにより、充填部材１６を筒状体１２に対して後退させる際に、使用者の指を掛けることができる。 The shape of the gripping portion 45 may be any shape that can be pulled in the proximal direction when filling the bone cement and can be pressed in the radial direction when the shaft portion 44 is broken. Further, a shape in which a through hole is provided in the side portion may be used. Further, by providing the through hole, the user's finger can be hooked when the filling member 16 is moved backward with respect to the cylindrical body 12.
　図１及び図２に示すように、本実施形態に係る薬剤注入具１０Ａは、筒状体１２の周囲を覆うカバー部材５２をさらに備える。カバー部材５２は、両端が開口した円筒形状であり、基端側から筒状体１２が挿通可能である。カバー部材５２とガイド部材３６とが結合した状態では、カバー部材５２は筒状体１２に対して軸線方向の移動が阻止されるが、カバー部材５２とガイド部材３６とが分離した状態では、カバー部材５２は、筒状体１２に対して軸線方向に変位可能である。カバー部材５２は、筒状体１２を略覆うことが可能な長さを有する。好ましくは、筒状体１２がカバー部材５２に挿通され且つガイド部材３６とカバー部材５２とが連結した状態（図２の状態）で、筒状体１２の先端（先端管部２０）は、カバー部材５２の先端から突出する。 As shown in FIGS. 1 and 2, the pharmaceutical injection device 10 </ b> A according to the present embodiment further includes a cover member 52 that covers the periphery of the cylindrical body 12. The cover member 52 has a cylindrical shape with both ends opened, and the cylindrical body 12 can be inserted from the base end side. In the state where the cover member 52 and the guide member 36 are coupled, the cover member 52 is prevented from moving in the axial direction with respect to the cylindrical body 12, but in the state where the cover member 52 and the guide member 36 are separated, the cover member 52 is covered. The member 52 can be displaced in the axial direction with respect to the cylindrical body 12. The cover member 52 has a length that can substantially cover the cylindrical body 12. Preferably, in a state where the cylindrical body 12 is inserted through the cover member 52 and the guide member 36 and the cover member 52 are connected (the state shown in FIG. 2), the distal end (the distal end pipe portion 20) of the cylindrical body 12 is a cover. Projecting from the tip of the member 52.
　図２に示すように、カバー部材５２は、挿通された筒状体１２の外周部に嵌合（接触）する嵌合部５４と、嵌合部５４の内径よりも大きい内径を有する拡径部５６とを有する。嵌合部５４は、カバー部材５２の基端部を構成する所定範囲にのみ設けられ、筒状体１２の外径と略同じ内径を有する。カバー部材５２の基端部内周には、ガイド部材３６が螺合可能な雌ネジ部５８が設けられる。 As shown in FIG. 2, the cover member 52 includes a fitting portion 54 that fits (contacts) with the outer peripheral portion of the inserted tubular body 12, and an enlarged diameter portion that has an inner diameter larger than the inner diameter of the fitting portion 54. 56. The fitting portion 54 is provided only in a predetermined range constituting the proximal end portion of the cover member 52 and has an inner diameter that is substantially the same as the outer diameter of the cylindrical body 12. A female screw portion 58 to which the guide member 36 can be screwed is provided on the inner periphery of the base end portion of the cover member 52.
　拡径部５６は、カバー部材５２における先端部から基端部近傍に渡る部分（基端部以外の部分）を構成し、筒状体１２の外径よりも大きい内径を有する。このため、カバー部材５２に筒状体１２が挿通された状態では、カバー部材５２の内周面と筒状体１２の外周面との間に、軸線方向に延在する環状の空隙６０（空気層）が形成される。この空隙６０は、断熱層として機能する。なお、カバー部材５２とガイド部材３６は一体的に形成されていてもよい。 The enlarged diameter portion 56 constitutes a portion (a portion other than the proximal end portion) extending from the distal end portion to the vicinity of the proximal end portion in the cover member 52 and has an inner diameter larger than the outer diameter of the cylindrical body 12. For this reason, in a state where the cylindrical body 12 is inserted through the cover member 52, an annular gap 60 (air) extending in the axial direction between the inner peripheral surface of the cover member 52 and the outer peripheral surface of the cylindrical body 12. Layer) is formed. The void 60 functions as a heat insulating layer. The cover member 52 and the guide member 36 may be integrally formed.
　筒状体１２の外周部又はカバー部材５２の内周部に、部分的に突出する突起部が設けられ、筒状体１２の外周部とカバー部材５２の拡径部５６の内周部とが部分的に接触してもよい。この場合でも、筒状体１２の外周部と拡径部５６の内周部との間に空隙６０が形成される。 A protruding part that partially protrudes is provided on the outer peripheral part of the cylindrical body 12 or the inner peripheral part of the cover member 52, and the outer peripheral part of the cylindrical body 12 and the inner peripheral part of the enlarged diameter portion 56 of the cover member 52 are provided. Partial contact may be made. Even in this case, the gap 60 is formed between the outer peripheral portion of the cylindrical body 12 and the inner peripheral portion of the enlarged diameter portion 56.
　カバー部材５２の外周部に一部に軸線方向に延びる突起や溝を設けてもよい。これにより、注入操作時にカバー部材５２を把持する際に、使用者の手が滑りにくくなる。 A protrusion or groove extending in the axial direction may be provided in part on the outer periphery of the cover member 52. This makes it difficult for the user's hand to slip when gripping the cover member 52 during the injection operation.
　カバー部材５２の構成材料としては、上述した筒状体１２の構成材料として例示したものから選択することができる。また、カバー部材５２自体が発砲スチロール等の断熱性を有する材料により構成されてもよい。また、空隙６０がメッシュ構造や梁構造を有するものでもよい。カバー部材５２は、筒状体１２内の薬剤が視認できる程度の透明性があることが望ましい。 The constituent material of the cover member 52 can be selected from those exemplified as the constituent material of the cylindrical body 12 described above. Further, the cover member 52 itself may be made of a heat insulating material such as foamed polystyrene. Further, the gap 60 may have a mesh structure or a beam structure. The cover member 52 is desirably transparent enough to allow the medicine in the cylindrical body 12 to be visually recognized.
　図１及び図２に示すように、本実施形態に係る薬剤注入具１０には、筒状体１２に対する押し子１４の回転に伴って押し子１４を軸線方向に安定的に変位させるためのガイド部材３６が設けられる。ガイド部材３６は、押し子１４のシャフト３０に設けられた雄ネジ部３４に螺合可能な雌ネジ部６１が貫通形成された基部６２と、雌ネジ部６１よりも径方向外側で基部６２の前面から先端方向に延出し且つ外周に雄ネジ部６４が形成されたネジ筒６６とを有する。雌ネジ部６１は、押し子１４に設けられた雄ネジ部３４と螺合可能である。ガイド部材３６のネジ筒６６に設けられた雄ネジ部６４は、カバー部材５２に設けられた雌ネジ部５８と螺合可能である。 As shown in FIGS. 1 and 2, the drug injection device 10 according to the present embodiment has a guide for stably displacing the pusher 14 in the axial direction along with the rotation of the pusher 14 with respect to the cylindrical body 12. A member 36 is provided. The guide member 36 includes a base portion 62 in which a female screw portion 61 that can be screwed into a male screw portion 34 provided on the shaft 30 of the pusher 14 is formed, and a base portion 62 that is radially outward from the female screw portion 61. A threaded cylinder 66 extending from the front surface in the distal direction and having a male threaded portion 64 formed on the outer periphery. The female screw portion 61 can be screwed with the male screw portion 34 provided on the pusher 14. The male screw portion 64 provided on the screw cylinder 66 of the guide member 36 can be screwed with the female screw portion 58 provided on the cover member 52.
　薬剤注入具１０Ａでは、ガイド部材３６に設けられた雌ネジ部６１と、押し子１４に設けられた雄ネジ部３４とにより、筒状体１２に対する押し子１４の回転に伴って筒状体１２に対して押し子１４を軸線方向に変位させる送りネジ構造７０（図２参照）が構成されている。ガイド部材３６の構成材料としては、上述した筒状体１２の構成材料として例示したものから選択することができる。 In the medicine injection device 10 </ b> A, the cylindrical body 12 is rotated with the rotation of the pusher 14 with respect to the cylindrical body 12 by the female screw part 61 provided on the guide member 36 and the male screw part 34 provided on the pusher 14. In contrast, a feed screw structure 70 (see FIG. 2) for displacing the pusher 14 in the axial direction is configured. As a constituent material of the guide member 36, it can select from what was illustrated as a constituent material of the cylindrical body 12 mentioned above.
　ガイド部材３６とカバー部材５２とをネジ嵌合により連結した状態において、筒状体１２のフランジ部２２は、ガイド部材３６（具体的には、ガイド部材３６のネジ筒６６の端面）とカバー部材５２（具体的には、カバー部材５２の嵌合部５４の基端面）とにより軸線方向に挟まれる。これにより、ガイド部材３６が筒状体１２に対して軸線方向に相対移動不可能に固定される。すなわち、本実施形態において、ガイド部材３６は、筒状体１２に対する押し子１４の移動をガイドする機能だけでなく、筒状体１２とカバー部材５２とを相互固定する連結手段としての機能をも兼ね備える。 In a state in which the guide member 36 and the cover member 52 are coupled by screw fitting, the flange portion 22 of the cylindrical body 12 is configured such that the guide member 36 (specifically, the end surface of the screw cylinder 66 of the guide member 36) and the cover member. 52 (specifically, the base end surface of the fitting portion 54 of the cover member 52) is sandwiched in the axial direction. As a result, the guide member 36 is fixed so as not to move relative to the cylindrical body 12 in the axial direction. That is, in this embodiment, the guide member 36 has not only a function of guiding the movement of the pusher 14 with respect to the cylindrical body 12 but also a function as a connecting means for fixing the cylindrical body 12 and the cover member 52 to each other. Have both.
　図１に示すように、カバー部材５２の基端側で、筒状体１２のフランジ部２２が嵌まり込む部分７２は、フランジ部２２に対応する溝形状に形成されている。このため、ガイド部材３６とカバー部材５２とをネジ嵌合により連結した状態では、前記部分７２とフランジ部２２とが係合することにより、カバー部材５２と筒状体１２との相対回転が防止される。すなわち、前記部分７２とフランジ部２２とにより、筒状体１２とカバー部材５２の周方向の相対回転を防止する回転防止手段が構成される。 As shown in FIG. 1, at the base end side of the cover member 52, the flange portion 22 fits writes portion 72 of the tubular member 12 is formed into a groove shape corresponding to the flange portion 22. For this reason, in the state where the guide member 36 and the cover member 52 are connected by screw fitting, the relative rotation between the cover member 52 and the cylindrical body 12 is prevented by the engagement between the portion 72 and the flange portion 22. Is done. That is, the portion 72 and the flange portion 22 constitute a rotation preventing means for preventing relative rotation of the cylindrical body 12 and the cover member 52 in the circumferential direction.
　なお、筒状体１２とカバー部材５２との相対回転を防止する手段は、図１等に示した構成に限られず、例えば、筒状体１２の外周部とカバー部材５２の内周部の一方に突起を設け、他方に当該突起と係合する溝を設け、当該突起と溝との係合により筒状体１２とカバー部材５２との周方向の相対回転が防止されるように構成されてもよい。 The means for preventing the relative rotation between the cylindrical body 12 and the cover member 52 is not limited to the configuration shown in FIG. 1 and the like. For example, one of the outer peripheral portion of the cylindrical body 12 and the inner peripheral portion of the cover member 52 is used. A protrusion is provided on the other side, and a groove that engages with the protrusion is provided on the other side. The engagement between the protrusion and the groove prevents relative rotation of the cylindrical body 12 and the cover member 52 in the circumferential direction. Also good.
　本実施形態に係る薬剤注入具１０Ａは、基本的には以上のように構成されるものであり、以下、その作用及び効果を説明する。 The drug injection device 10A according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.
　先ず、薬剤注入具１０Ａに薬剤の一例としての骨セメントを充填する方法を説明する。図３Ａに示すように、骨セメントを充填するために、薬剤注入具１０Ａを、押し子１４及び充填部材１６が筒状体１２に挿入され且つカバー部材５２とガイド部材３６とが連結された状態にする。この場合、押し子１４はその可動範囲の基端側に移動させておき、充填部材１６はその可動範囲の最も先端側に移動させておく。 First, a method for filling a bone cement as an example of a drug in the drug injection device 10A will be described. As shown in FIG. 3A, in order to fill the bone cement, the drug injector 10A is inserted into the cylindrical body 12 with the pusher 14 and the filling member 16 and the cover member 52 and the guide member 36 are connected. To. In this case, the pusher 14 is moved to the proximal end side of the movable range, and the filling member 16 is moved to the most distal side of the movable range.
　次に、ノズルとして機能する吸引ポート８０を筒状体１２の先端管部２０に螺合して装着する。吸引ポート８０の基端外周には、ロック部２８の内周部に設けられた雌ネジ部２７（図１参照）に螺合可能な雄ネジ部８２が設けられている。筒状体１２の先端管部２０に吸引ポート８０を接続したら、容器８４内に用意された骨セメント８６に吸引ポート８０の先端部を埋没させた状態とする。なお、先端管部２０に対する吸引ポート８０の装着は、押し子１４を筒状体１２内に挿入する前に実施してもよい。 Next, the suction port 80 functioning as a nozzle is screwed into the distal end tube portion 20 of the cylindrical body 12 and attached. A male screw portion 82 that can be screwed into a female screw portion 27 (see FIG. 1) provided on the inner peripheral portion of the lock portion 28 is provided on the outer periphery of the proximal end of the suction port 80. When the suction port 80 is connected to the distal end tube portion 20 of the tubular body 12, the distal end portion of the suction port 80 is buried in the bone cement 86 prepared in the container 84. The suction port 80 may be attached to the distal end tube portion 20 before the pusher 14 is inserted into the cylindrical body 12.
　次に、図３Ｂに示すように、骨セメント８６に吸引ポート８０の先端部を埋没させた状態で、筒状体１２に対して充填部材１６を基端方向に引っ張る。本実施形態の場合、押し子１４のハンドル３２には切欠部３８が設けられているため、使用者は、当該切欠部３８を通して把持部４５に手指を引っ掛けることができるため、引っ張り操作を容易に行うことができる。そして、このように充填部材１６を基端方向に引っ張ると、充填部材１６の移動に伴って、骨セメント８６が吸引ポート８０及び先端管部２０を介して筒状体１２内に吸引される。これにより、図３Ｂに示すように、骨セメント８６が筒状体１２内に充填されるに至る。筒状体１２内への骨セメント８６の充填量は、例えば、５～２０ｍＬ程度である。次に、筒状体１２の先端管部２０から吸引ポート８０の接続を解除する。 Next, as shown in FIG. 3B, the filling member 16 is pulled in the proximal direction with respect to the tubular body 12 with the distal end portion of the suction port 80 buried in the bone cement 86. In the case of this embodiment, since the handle 32 of the pusher 14 is provided with the notch 38, the user can hook his / her finger on the grip 45 through the notch 38, so that the pulling operation can be easily performed. It can be carried out. When the filling member 16 is pulled in the proximal direction as described above, the bone cement 86 is sucked into the cylindrical body 12 through the suction port 80 and the distal end tube portion 20 as the filling member 16 moves. Thereby, as shown in FIG. 3B, the bone cement 86 is filled into the cylindrical body 12. The filling amount of the bone cement 86 into the cylindrical body 12 is, for example, about 5 to 20 mL. Next, the suction port 80 is disconnected from the distal end tube portion 20 of the cylindrical body 12.
　この場合、筒状体１２内において、充填部材１６の先端側には、若干のエアが存在する。筒状体１２内にエアが存在した状態では、当該エアがダンパーとして作用することにより骨セメント８６の吐出が困難となり、あるいは、骨セメント８６を吐出できても応答性が悪く、骨セメント８６の骨内への注入量を正確に制御することが困難となる。このため、次に、筒状体１２内のエアを抜くエア排出作業を行う。 In this case, a slight amount of air is present on the distal end side of the filling member 16 in the cylindrical body 12. In a state where air is present in the cylindrical body 12, it becomes difficult to discharge the bone cement 86 due to the air acting as a damper, or even if the bone cement 86 can be discharged, the responsiveness is poor. It becomes difficult to accurately control the amount of injection into the bone. For this reason, next, the air discharge | emission operation | work which extracts the air in the cylindrical body 12 is performed.
　エア排出作業では、図４Ａに示すように、薬剤注入具１０Ａの先端を上方に向け、その状態でしばらく待機する。そうすると、骨セメント８６内でエアが徐々に上昇していき、最終的には、骨セメント８６の上方へと出ていく。そして、図４Ｂに示すように、筒状体１２に対して押し子１４を周方向に回転させて前進させると、押し子１４の先端面が充填部材１６のヘッド部４２の基端面に当接し、押し子１４によって充填部材１６が押し上げられる（前進させられる）。そして、骨セメント８６の充填終了時に存在していたエアの体積に相当する分だけ充填部材１６を前進させることにより、筒状体１２内からエアを完全に排出することができる。 In the air discharging operation, as shown in FIG. 4A, the tip of the medicine injection tool 10A is turned upward, and the apparatus waits for a while in this state. Then, the air gradually rises in the bone cement 86 and finally goes out above the bone cement 86. As shown in FIG. 4B, when the pusher 14 is rotated in the circumferential direction relative to the cylindrical body 12 and advanced, the distal end surface of the pusher 14 comes into contact with the proximal end surface of the head portion 42 of the filling member 16. The filling member 16 is pushed up (advanced) by the pusher 14. Then, the air can be completely discharged from the cylindrical body 12 by advancing the filling member 16 by an amount corresponding to the volume of air existing at the end of filling the bone cement 86.
　押し子１４を回転操作して骨セメント８６を筒状体１２内から吐出させる際には、充填部材１６の把持部４５は不要である。そこで、筒状体１２内からエアを排出したら、次に、必要に応じて、図５に示すように、充填部材１６の第１部位４４Ａから第２部位４４Ｂを分離させることにより、充填部材１６の第２部位４４Ｂから後ろ側の部分を取り除く分離作業を行う。本実施形態では、具体的には、充填部材１６の軸部４４に所定以上の曲げ応力を作用させることにより、軸部４４を脆弱部４８の部分で折り曲げて破断させる。この結果、充填部材１６の第１部位４４Ａから第２部位４４Ｂが分離されるに至る。 When the pusher 14 is rotated to discharge the bone cement 86 from the tubular body 12, the gripping portion 45 of the filling member 16 is not necessary. Therefore, after the air is discharged from the cylindrical body 12, the filling member 16 is then separated by separating the second portion 44B from the first portion 44A of the filling member 16 as shown in FIG. A separation operation for removing a rear portion from the second portion 44B is performed. In the present embodiment, specifically, by applying a bending stress of a predetermined level or more to the shaft portion 44 of the filling member 16, the shaft portion 44 is bent at the weakened portion 48 and broken. As a result, the second portion 44B of the filling member 16 is separated from the first portion 44A.
　次に、骨セメント８６を充填した薬剤注入具１０Ａの操作方法について、当該薬剤注入具１０Ａを用いて経皮的椎体形成術を実施する場合を例に挙げて説明する。 Next, an operation method of the drug injection device 10A filled with the bone cement 86 will be described taking as an example a case where a percutaneous vertebroplasty is performed using the drug injection device 10A.
　図６Ａに示すように、薬剤注入具１０Ａの筒状体１２と、骨セメント８６の注入対象である骨９０に穿刺された骨セメント注入針９２の注入ポート９４とを、延長チューブ８８を介して連結する。この延長チューブ８８を用いることで、使用者の手をＸ線照射領域の外に退避させた状態で、薬剤注入具１０Ａを操作することが可能となる。 As shown in FIG. 6A, the cylindrical body 12 of the drug injection device 10A and the injection port 94 of the bone cement injection needle 92 pierced into the bone 90 to be injected with the bone cement 86 are connected via the extension tube 88. Link. By using the extension tube 88, the medicine injection tool 10A can be operated with the user's hand retracted outside the X-ray irradiation region.
　ここで、骨セメント注入針９２は、例えば、金属材料で構成された中空構造の穿刺針９６と、穿刺針９６の基端部に固定された、例えば、樹脂材料で構成されたハンドル９８とを有する。ハンドル９８の上部には、穿刺針９６の内腔（中空部）と連通した注入ポート９４が設けられている。延長チューブ８８の一端には、注入ポート９４と着脱可能に連結するコネクタ１００が設けられ、延長チューブ８８の他端には、筒状体１２の先端管部２０及びロック部２８と着脱可能なコネクタ１０２が設けられている。 Here, the bone cement injection needle 92 includes a hollow puncture needle 96 made of, for example, a metal material, and a handle 98 made of, for example, a resin material fixed to the proximal end portion of the puncture needle 96. Have. An injection port 94 communicating with the lumen (hollow portion) of the puncture needle 96 is provided on the upper portion of the handle 98. One end of the extension tube 88 is provided with a connector 100 that is detachably connected to the injection port 94, and the other end of the extension tube 88 is a connector that is detachable from the distal end tube portion 20 and the lock portion 28 of the cylindrical body 12. 102 is provided.
　延長チューブ８８は、可撓性があるチューブ壁内あるいは外面にケブラー（登録商標）、ナイロン、ポリフェニレンサルファイド、ステンレス等の糸を網あるいはコイル状に巻いた構成であると、耐圧の点から好適であるが、内面にのみ耐薬品性のあるポリプロピレンやフッ素樹脂等を配置した多層チューブとしてもよい。延長チューブ８８の長さは、使用者の手をＸ線照射領域の外に確実に退避できるように、２００～５００ｍｍ程度に設定されるのがよい。また、延長チューブ８８の先端部分がアングル付けされているとよい。 The extension tube 88 preferably has a structure in which a thread such as Kevlar (registered trademark), nylon, polyphenylene sulfide, stainless steel or the like is wound around a flexible tube wall or on the outer surface in a net or coil shape. However, it may be a multi-layer tube in which chemical resistant polypropylene or fluororesin is disposed only on the inner surface. The length of the extension tube 88 is preferably set to about 200 to 500 mm so that the user's hand can be reliably retracted outside the X-ray irradiation region. Further, the distal end portion of the extension tube 88 may be angled.
　図６Ａでは、このような延長チューブ８８の一端に設けられたコネクタ１００がハンドル９８の注入ポート９４に連結され、延長チューブ８８の他端に設けられたコネクタ１０２が筒状体１２の先端管部２０及びロック部２８に連結されている。 In FIG. 6A, the connector 100 provided at one end of the extension tube 88 is connected to the injection port 94 of the handle 98, and the connector 102 provided at the other end of the extension tube 88 is the tip tube portion of the cylindrical body 12. 20 and the lock portion 28.
　このような状態で、Ｘ線透視下で、薬剤注入具１０Ａに充填された骨セメント８６を吐出し、骨９０内に注入する。この注入操作では、図６Ｂに示すように、押し子１４を回転操作することにより押し子１４とともに充填部材１６を筒状体１２に対して先端側に移動させていく。すなわち、充填部材１６は、ヘッド部４２の部分で押し子１４により先端方向に押圧されるため、押し子１４の先端方向への移動に伴って、充填部材１６も先端方向へ移動させられる。 In such a state, the bone cement 86 filled in the drug injection device 10A is discharged and injected into the bone 90 under fluoroscopy. In this injection operation, as shown in FIG. 6B, the pusher 14 is rotated to move the filling member 16 together with the pusher 14 toward the distal end side with respect to the cylindrical body 12. That is, since the filling member 16 is pressed in the distal direction by the pusher 14 at the portion of the head portion 42, the filling member 16 is also moved in the distal direction as the pusher 14 moves in the distal direction.
　この場合、薬剤注入具１０Ａは、筒状体１２とカバー部材５２の周方向の相対回転を阻止する回転防止手段（筒状体１２のフランジ部２２及びカバー部材５２の部分７２。図１参照）を備えるため、カバー部材５２を把持した状態で押し子１４を回転させても、筒状体１２が連れ回ることを防止できる。このため、筒状体１２に連結された延長チューブ８８又は骨セメント注入針９２が、押し子１４の回転に伴って回転することを防止でき、手技に支障を来すことがない。 In this case, the drug injection device 10A is configured to prevent rotation of the cylindrical body 12 and the cover member 52 in the circumferential direction (a flange portion 22 of the cylindrical body 12 and a portion 72 of the cover member 52, see FIG. 1). Therefore, even if the pusher 14 is rotated while the cover member 52 is gripped, the cylindrical body 12 can be prevented from being rotated. For this reason, the extension tube 88 or the bone cement injection needle 92 connected to the cylindrical body 12 can be prevented from rotating with the rotation of the pusher 14, and the procedure is not hindered.
　筒状体１２内で充填部材１６のヘッド部４２が前進することに伴い、筒状体１２内の充填室が高圧に加圧され、骨セメント８６が、先端管部２０、延長チューブ８８及び骨セメント注入針９２を介して骨９０内に注入される。このような押し子１４に対する回転操作によって骨セメント８６を目標注入量まで注入する。 As the head portion 42 of the filling member 16 moves forward in the cylindrical body 12, the filling chamber in the cylindrical body 12 is pressurized to a high pressure, and the bone cement 86 is replaced with the distal end pipe portion 20, the extension tube 88, and the bone. It is injected into the bone 90 through a cement injection needle 92. The bone cement 86 is injected to the target injection amount by such a rotation operation with respect to the pusher 14.
　注入操作を行う間、筒状体１２の周囲がカバー部材５２で覆われるとともに、筒状体１２とカバー部材５２との間に形成された空隙６０（図２参照）が断熱層として機能するため、操作時に使用者の手指を介して体温が筒状体１２内の骨セメント８６に伝達することが抑制される。従って、骨セメント８６の粘度の上昇速度を抑えることができる。 During the injection operation, the periphery of the cylindrical body 12 is covered with the cover member 52, and the gap 60 (see FIG. 2) formed between the cylindrical body 12 and the cover member 52 functions as a heat insulating layer. The body temperature is suppressed from being transmitted to the bone cement 86 in the tubular body 12 through the user's fingers during operation. Therefore, the increase rate of the viscosity of the bone cement 86 can be suppressed.
　以上説明したように、本実施形態に係る薬剤注入具１０Ａは、押し子１４よりも先端側で筒状体１２の中空部に液密に挿入されるヘッド部４２が設けられた充填部材１６を備える。この構成により、薬剤注入具１０Ａの先端に接続された吸引ポート８０の先端を、容器８４等に収容された薬剤内に入れ、充填部材１６を筒状体１２に対して後退させると、充填部材１６の後退に伴って、薬剤が、筒状体１２の薬剤吐出口１２ａを介して筒状体１２内へと吸引される。従って、薬剤注入具１０Ａの筒状体１２内に薬剤を簡易に充填することができる。 As described above, the pharmaceutical injection device 10A according to the present embodiment includes the filling member 16 provided with the head portion 42 that is liquid-tightly inserted into the hollow portion of the cylindrical body 12 on the tip side of the pusher 14. Prepare. With this configuration, when the tip of the suction port 80 connected to the tip of the medicine injection device 10A is placed in the medicine accommodated in the container 84 or the like and the filling member 16 is retracted with respect to the cylindrical body 12, the filling member With the retraction of 16, the medicine is sucked into the cylindrical body 12 through the medicine discharge port 12a of the cylindrical body 12. Accordingly, the drug can be easily filled into the cylindrical body 12 of the drug injection tool 10A.
　また、本実施形態の場合、押し子１４は充填部材１６に対して周方向に回転可能であるため、薬剤を吐出させる際に押し子１４を回転操作して押し子１４により充填部材１６を先端方向に移動させる場合に、筒状体１２に対して充填部材１６はほぼ回転せず、押し子１４のみが筒状体１２に対して回転する。すなわち、ヘッド部４２の外周部に装着されたシール部材４６と筒状体１２の内周面との摩擦抵抗と、ヘッド部４２と薬剤との摩擦抵抗とがあるため、押し子１４の先端面とヘッド部４２の基端面とが接触した状態で押し子１４が回転しても、充填部材１６がほぼ回転することがない。従って、押し子１４を回転操作するために必要な操作力を有効に低減することができ、操作性に優れる。 In this embodiment, since the pusher 14 can be rotated in the circumferential direction with respect to the filling member 16, the pusher 14 is rotated to discharge the medicine, and the filling member 16 is moved to the tip by the pusher 14. When moving in the direction, the filling member 16 does not substantially rotate with respect to the cylindrical body 12, and only the pusher 14 rotates with respect to the cylindrical body 12. That is, since there is a frictional resistance between the seal member 46 attached to the outer peripheral part of the head part 42 and the inner peripheral surface of the cylindrical body 12 and a frictional resistance between the head part 42 and the medicine, the distal end face of the pusher 14 Even if the pusher 14 rotates with the base end surface of the head portion 42 in contact with the filling member 16, the filling member 16 does not substantially rotate. Therefore, it is possible to effectively reduce the operating force required to rotate the pusher 14, and the operability is excellent.
　しかも、押し子１４の先端部は先細り形状となっていることから、頭部３１の環状先端面３１ａ（図１及び図２参照）と、ヘッド部４２の基端面との接触面積は相当に小さい。このため、環状先端面３１ａとヘッド部４２の基端面との間の摩擦抵抗が好適に抑制され、押し子１４の回転操作に要する操作力を一層効果的に低減できる。 Moreover, since the distal end portion of the pusher 14 has a tapered shape, the contact area between the annular distal end surface 31a (see FIGS. 1 and 2) of the head portion 31 and the proximal end surface of the head portion 42 is considerably small. . For this reason, the frictional resistance between the annular distal end surface 31a and the base end surface of the head portion 42 is suitably suppressed, and the operation force required for the rotation operation of the pusher 14 can be further effectively reduced.
　また、充填部材１６の軸部４４の外周面と押し子１４の筒状体１２の挿通孔３０ａの内周面の間には隙間があり、軸部４４と筒状体１２は接触しないように構成されている。これにより、充填部材１６と押し子１４との間の摩擦抵抗が好適に抑制され、押し子１４の回転操作に要する操作力を一層効果的に低減できる。 Further, there is a gap between the outer peripheral surface of the shaft portion 44 of the filling member 16 and the inner peripheral surface of the insertion hole 30a of the cylindrical body 12 of the pusher 14 so that the shaft portion 44 and the cylindrical body 12 do not come into contact with each other. It is configured. Thereby, the frictional resistance between the filling member 16 and the pusher 14 is suitably suppressed, and the operation force required for the rotation operation of the pusher 14 can be further effectively reduced.
　本実施形態の場合、押し子１４の軸部４４は、軸線方向の途中位置で先端側の第１部位４４Ａと基端側の第２部位４４Ｂとに分離可能である。この構成によれば、薬剤を筒状体１２内に充填した後に、第１部位４４Ａから第２部位４４Ｂを分離すると、押し子１４を回転操作する際に、充填部材１６が邪魔にならず、操作性に優れる。 In the case of the present embodiment, the shaft portion 44 of the pusher 14 can be separated into a first portion 44A on the distal end side and a second portion 44B on the proximal end side at an intermediate position in the axial direction. According to this configuration, after separating the second part 44B from the first part 44A after filling the cylindrical body 12, the filling member 16 does not get in the way when the pusher 14 is rotated, Excellent operability.
　特に、本実施形態の場合、軸部４４は、軸線方向の途中位置に脆弱部４８を有し、第１部位４４Ａと第２部位４４Ｂとは、軸部４４に所定以上の曲げ応力が作用した際に脆弱部４８が破断することにより分離可能となっている。 In particular, in the case of the present embodiment, the shaft portion 44 has a fragile portion 48 at an intermediate position in the axial direction, and the first portion 44A and the second portion 44B are subjected to a bending stress of a predetermined level or more on the shaft portion 44. At this time, the fragile portion 48 is broken and can be separated.
　本実施形態の場合、押し子１４のハンドル３２には、充填部材１６の軸部４４が進入可能な溝部４０（図１参照）が設けられる。この構成によれば、充填部材１６を折り曲げて第１部位４４Ａから第２部位４４Ｂを分離させる際に、その軸部４４がハンドル３２に設けられた溝部４０に進入するため、充填部材１６の軸部４４を折る操作を容易に実施できる。 In the case of this embodiment, the handle 32 of the pusher 14 is provided with a groove portion 40 (see FIG. 1) into which the shaft portion 44 of the filling member 16 can enter. According to this configuration, when the filling member 16 is bent to separate the second portion 44B from the first portion 44A, the shaft portion 44 enters the groove portion 40 provided in the handle 32, so that the shaft of the filling member 16 is removed. The operation of folding the portion 44 can be easily performed.
　本実施形態の場合、充填部材１６の把持部４５の側部には、有底の凹部５０（図１参照）が設けられるため、把持部４５の側方から凹部５０を押圧することにより、充填部材１６の軸部４４を折る操作を容易に実施することができる。 In the case of the present embodiment, a bottomed concave portion 50 (see FIG. 1) is provided on the side portion of the gripping portion 45 of the filling member 16, so that the filling is performed by pressing the concave portion 50 from the side of the gripping portion 45. The operation of folding the shaft portion 44 of the member 16 can be easily performed.
　また、上述した薬剤注入具１０Ａの筒状体１２の先端管部２０又は延長チューブ８８の一部に、使用者が注入圧を確認するための圧力計を設けてもよい。 Further, a pressure gauge for the user to check the injection pressure may be provided on a part of the distal end tube portion 20 or the extension tube 88 of the cylindrical body 12 of the drug injection device 10A described above.
［第２実施形態］
　図７は、本発明の第２実施形態に係る薬剤注入具１０Ｂの縦断面図である。なお、第２実施形態に係る薬剤注入具１０Ｂにおいて、第１実施形態に係る薬剤注入具１０Ａと同一又は同様な機能及び効果を奏する要素には同一の参照符号を付し、詳細な説明を省略する。 [Second Embodiment]
FIG. 7 is a longitudinal sectional view of a pharmaceutical injection device 10B according to the second embodiment of the present invention. In the drug injection device 10B according to the second embodiment, elements having the same or similar functions and effects as those of the drug injection device 10A according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted. To do.
　図７に示すように、この薬剤注入具１０Ｂは、充填部材１１０の構成において、上述した第１実施形態に係る薬剤注入具１０Ａと異なる。具体的には、充填部材１１０は、軸線方向に沿ってヘッド部４２の先端面まで延在するエア排出路１１２を有し、第２部位４４Ｂが第１部位４４Ａから分離した際、エア排出路１１２を介して、筒状体１２内と外気とが連通する。なお、エア排出路１１２の基端側は、第２部位４４Ｂが第１部位４４Ａから分離されるまでは外気と連通することはない。図７に示すエア排出路１１２は、軸部４４に設けられた細孔である。なお、図７では、エア排出路１１２は、ヘッド部４２の先端面まで延在しているが、シール部材４６より先端側であれば、ヘッド部４２の側部面に延在していてもよい。図７では、エア排出路１１２の基端は、軸部４４の基端まで達しているが、少なくとも脆弱部４８がある箇所まで達していればよい。エア排出路１１２が細孔で構成される場合、当該細孔は１つに限られず、軸部４４内に複数の細孔が平行に設けられてもよい。あるいは、エア排出路１１２は、互いに連通した気孔を有する多孔質体で構成されてもよい。充填部材１１０のその他の部分の構成は、第１実施形態における充填部材１６と同じである。 As shown in Fig. 7, the drug injection device 10B is different from the drug injection device 10A according to the first embodiment described above in the configuration of the filling member 110. Specifically, the filling member 110 has an air discharge path 112 extending to the distal end surface of the head portion 42 along the axial direction, and when the second portion 44B is separated from the first portion 44A, the air discharge passage. The inside of the cylindrical body 12 and the outside air communicate with each other through 112. The base end side of the air discharge path 112 does not communicate with the outside air until the second part 44B is separated from the first part 44A. The air discharge path 112 shown in FIG. 7 is a pore provided in the shaft portion 44. In FIG. 7, the air discharge path 112 extends to the front end surface of the head portion 42, but it may extend to the side surface of the head portion 42 as long as it is on the front end side from the seal member 46. Good. In FIG. 7, the base end of the air discharge path 112 reaches the base end of the shaft portion 44, but it is sufficient that it reaches at least a portion where the fragile portion 48 is present. In the case where the air discharge path 112 is configured by pores, the number of the pores is not limited to one, and a plurality of pores may be provided in parallel in the shaft portion 44. Alternatively, the air discharge path 112 may be formed of a porous body having pores communicating with each other. The structure of the other parts of the filling member 110 is the same as that of the filling member 16 in the first embodiment.
　次に、上記のように構成された薬剤注入具１０Ｂに、薬剤の一例としての骨セメントを充填する方法を説明する。図８Ａに示すように、骨セメント８６を充填するために、薬剤注入具１０Ｂを、押し子１４及び充填部材１１０が筒状体１２に挿入され且つカバー部材５２とガイド部材３６とが連結された状態にする。この場合、押し子１４はその可動範囲の基端側に移動させておき、充填部材１１０はその可動範囲の最も先端側に移動させておく。次に、吸引ポート８０を筒状体１２のロック部２８に螺合して装着し、吸引ポート８０の先端を骨セメント８６に埋没させる。筒状体１２に対する吸引ポート８０の装着は、カバー部材５２とガイド部材３６とを連結する前に実施してもよい。 Next, a method for filling a bone cement as an example of a drug in the drug injection device 10B configured as described above will be described. As shown in FIG. 8A, in order to fill the bone cement 86, the pusher 14 and the filling member 110 are inserted into the cylindrical body 12 and the cover member 52 and the guide member 36 are connected. Put it in a state. In this case, the pusher 14 is moved to the proximal end side of the movable range, and the filling member 110 is moved to the most distal side of the movable range. Next, the suction port 80 is screwed and attached to the lock portion 28 of the cylindrical body 12, and the tip of the suction port 80 is buried in the bone cement 86. The attachment of the suction port 80 to the cylindrical body 12 may be performed before the cover member 52 and the guide member 36 are connected.
　次に、図８Ｂに示すように、容器８４内の骨セメント８６に吸引ポート８０の先端部を埋没させた状態で、筒状体１２に対して充填部材１１０を基端方向に引っ張ると、充填部材１１０の移動に伴って、骨セメント８６が吸引ポート８０及び先端管部２０を介して筒状体１２内に吸引される。これにより、骨セメント８６が筒状体１２内に充填される。筒状体１２内への骨セメント８６の充填量は、例えば、５～２０ｍＬ程度である。 Next, as shown in FIG. 8B, when the distal end portion of the suction port 80 is buried in the bone cement 86 in the container 84, when the filling member 110 is pulled in the proximal direction with respect to the cylindrical body 12, the filling is performed. As the member 110 moves, the bone cement 86 is sucked into the cylindrical body 12 through the suction port 80 and the distal end tube portion 20. Thereby, the bone cement 86 is filled in the cylindrical body 12. The filling amount of the bone cement 86 into the cylindrical body 12 is, for example, about 5 to 20 mL.
　この場合、筒状体１２内において、充填部材１１０の先端側には、若干のエアが存在するため、次に、筒状体１２内のエアを抜くエア排出作業を行う。エア排出作業では、図９Ａに示すように、薬剤注入具１０Ｂの先端を下方に向けたまま、充填部材１１０の軸部４４を脆弱部４８の部分で折り曲げて破損させることにより、第１部位４４Ａから第２部位４４Ｂを分離させる。この結果、エア排出路１１２を介して、筒状体１２内と外気とが連通する。 In this case, since some air is present at the tip end side of the filling member 110 in the cylindrical body 12, next, an air discharging operation for extracting the air in the cylindrical body 12 is performed. In the air discharging operation, as shown in FIG. 9A, the shaft 44 of the filling member 110 is bent and broken at the weakened portion 48 with the tip of the medicine injection device 10B facing downward, so that the first portion 44A The second portion 44B is separated from the first portion. As a result, the inside of the cylindrical body 12 communicates with the outside air via the air discharge path 112.
　次に、図９Ｂに示すように、押し子１４を回転操作して前進させると、充填部材１１０のヘッド部４２が押し子１４の頭部３１によって押し下げられることで、充填部材１１０が下降する。充填部材１１０の下降の過程で、筒状体１２内のエアは、エア排出路１１２を通って外部に排出される。そして、骨セメント８６の充填終了時に存在していたエアの体積に相当する分だけ充填部材１１０を下降させることにより、筒状体１２内からエアを完全に排出することができる。この場合、高粘度且つ硬化性の骨セメント８６は、細いエア排出路１１２を通る過程で硬化するため、骨セメント８６が第１部位４４Ａの基端から漏れ出ることはほぼない。 Next, as shown in FIG. 9B, when the pusher 14 is rotated and moved forward, the head portion 42 of the filling member 110 is pushed down by the head 31 of the pusher 14, thereby lowering the filling member 110. In the process of lowering the filling member 110, the air in the cylindrical body 12 is discharged to the outside through the air discharge path 112. Then, the air can be completely discharged from the cylindrical body 12 by lowering the filling member 110 by an amount corresponding to the volume of air existing at the end of filling the bone cement 86. In this case, since the highly viscous and hardened bone cement 86 hardens in the process of passing through the thin air discharge passage 112, the bone cement 86 hardly leaks from the proximal end of the first portion 44A.
　このように、本実施形態に係る薬剤注入具１０Ｂによれば、薬剤を筒状体１２内に充填した後に行うエア排出作業において、充填部材１１０の軸部４４を第１部位４４Ａと第２部位４４Ｂとに分離させた状態で充填部材１１０を前進させることにより、筒状体１２を上方に向けなくても、筒状体１２内のエアを容易、迅速且つ確実に外部へと排出することができる。 Thus, according to the medicine injection tool 10B according to the present embodiment, in the air discharge operation performed after filling the cylindrical body 12 with the medicine, the shaft portion 44 of the filling member 110 is connected to the first portion 44A and the second portion. By advancing the filling member 110 in a state separated into 44B, the air in the cylindrical body 12 can be discharged to the outside easily, quickly and reliably without the cylindrical body 12 being directed upward. it can.
　なお、第２実施形態において、第１実施形態と共通する各構成部分については、第１実施形態における当該共通の各構成部分がもたらす作用及び効果と同一又は同様の作用及び効果が得られることは勿論である。 In addition, in the second embodiment, for each component common to the first embodiment, it is possible to obtain the same or similar operation and effect as the operation and effect brought about by the common component in the first embodiment. Of course.
［第３実施形態］
　図１０は、本発明の第３実施形態に係る薬剤注入具１０Ｃの縦断面図である。なお、第３実施形態に係る薬剤注入具１０Ｃにおいて、第１実施形態に係る薬剤注入具１０Ａと同一又は同様な機能及び効果を奏する要素には同一の参照符号を付し、詳細な説明を省略する。 [Third Embodiment]
FIG. 10 is a longitudinal sectional view of a pharmaceutical injection device 10C according to the third embodiment of the present invention. Note that in the drug injection device 10C according to the third embodiment, elements having the same or similar functions and effects as those of the drug injection device 10A according to the first embodiment are denoted by the same reference numerals, and detailed description thereof is omitted. To do.
　図１０に示すように、この薬剤注入具１０Ｃは、充填部材１２０及び押し子１２２の構成において、上述した第１実施形態に係る薬剤注入具１０Ａと異なる。具体的には、充填部材１２０の軸部４４には、外方に突出した第１凸部１２４が設けられる。この第１凸部１２４は、軸部４４における他の部分よりも径方向外方に膨出した環状突起であり、軸部４４の先端近傍に設けられる。シャフト３０には、内方に突出し且つ第１凸部１２４と係合可能な第２凸部１２６が設けられる。この第２凸部１２６は、シャフト３０の挿通孔３０ａにおける他の部分よりも径方向内方に膨出した環状突起であり、本実施形態では、シャフト３０の先端に設けられる。 As shown in Fig. 10, the drug injection device 10C is different from the drug injection device 10A according to the first embodiment described above in the configuration of the filling member 120 and the pusher 122. Specifically, the shaft portion 44 of the filling member 120 is provided with a first convex portion 124 that protrudes outward. The first convex portion 124 is an annular protrusion that bulges outward in the radial direction from the other portion of the shaft portion 44, and is provided near the tip of the shaft portion 44. The shaft 30 is provided with a second convex portion 126 that protrudes inward and engages with the first convex portion 124. The second protrusion 126 is an annular protrusion that bulges radially inward from the other portion of the insertion hole 30 a of the shaft 30, and is provided at the tip of the shaft 30 in this embodiment.
　第１凸部１２４の外径は、第２凸部１２６の内径よりも大きい。そのため、図１１Ａに示すように、筒状体１２内に薬剤（例えば、骨セメント８６）を充填するために充填部材１２０を引っ張って基端方向に移動させると、やがて第１凸部１２４と第２凸部１２６とが接触する。軸部４４に設けられた脆弱部４８及び第１凸部１２４と、シャフト３０に設けられた第２凸部１２６は、第１凸部１２４と第２凸部１２６とが接触した時点で脆弱部４８がシャフト３０の基端から外部に露出するように設定されている。充填部材１２０のその他の部分は、第１実施形態における充填部材１６と同様に構成されている。押し子１２２のその他の部分は、第１実施形態における押し子１４と同様に構成されている。 The outer diameter of the first convex portion 124 is larger than the inner diameter of the second convex portion 126. Therefore, as shown in FIG. 11A, when the filling member 120 is pulled and moved in the proximal direction in order to fill the cylindrical body 12 with a medicine (for example, bone cement 86), the first convex portion 124 and the first protrusion 124 are eventually formed. The two convex portions 126 come into contact. The weak part 48 and the first convex part 124 provided on the shaft part 44 and the second convex part 126 provided on the shaft 30 are the weak part when the first convex part 124 and the second convex part 126 contact each other. 48 is set to be exposed from the base end of the shaft 30 to the outside. Other portions of the filling member 120 are configured in the same manner as the filling member 16 in the first embodiment. Other portions of the pusher 122 are configured in the same manner as the pusher 14 in the first embodiment.
　上記のように構成された薬剤注入具１０Ｃによれば、薬剤を筒状体１２内に充填するために充填部材１２０を基端方向に移動させる過程で、第１凸部１２４と第２凸部１２６とが接触すると、充填部材１６の移動抵抗が増大する。そしてこの位置では、軸部４４に設けられた脆弱部４８は、押し子１４のシャフトの基端から外部に露出した位置にある。従って、軸部４４の切断可能位置が使用者に認識され易い。 According to the medicine injection device 10C configured as described above, in the process of moving the filling member 120 in the proximal direction in order to fill the cylindrical body 12, the first protrusion 124 and the second protrusion When 126 comes into contact, the movement resistance of the filling member 16 increases. At this position, the fragile portion 48 provided in the shaft portion 44 is in a position exposed to the outside from the base end of the shaft of the pusher 14. Accordingly, the position where the shaft portion 44 can be cut is easily recognized by the user.
　図１１Ｂに示すように、充填部材１２０をさらに引っ張ると、第１凸部１２４が第２凸部１２６を乗り越えることにより、充填部材１６をさらに基端方向に移動させることができる。すなわち、薬剤注入具１０Ｃでは、充填部材１２０に所定以上の軸力が作用したとき、第１凸部１２４が第２凸部１２６を乗り越えることが可能となっている。第１凸部１２４が第２凸部１２６を乗り越えた後は、ヘッド部４２がシャフト３０の頭部３１に当接する位置まで充填部材１２０を基端方向に引くことが可能である。 As shown in FIG. 11B, when the filling member 120 is further pulled, the filling member 16 can be further moved in the proximal direction by the first protrusion 124 getting over the second protrusion 126. In other words, in the medicine injection device 10 </ b> C, when a predetermined axial force or more acts on the filling member 120, the first convex portion 124 can get over the second convex portion 126. After the first protrusion 124 rides over the second projecting portion 126, the head unit 42 is capable of pulling the filler member 120 to a position abutting the head 31 of the shaft 30 in the proximal direction.
　このように構成された薬剤注入具１０Ｃの使用において、押し子１２２の回転操作による注入の最中に、注入を急停止したい場合には、押し子１２２を逆回転させればよい。そうすると、薬剤からの圧力によってヘッド部４２を含む充填部材１２０が後退することで、系内の圧力が確実に開放されるため、注入を確実に急停止でき、精密な注入を担保できる。この場合、系内の除圧を確実に行うべく、ヘッド部４２と頭部３１とが接触した状態での第１凸部１２４と第２凸部１２６との距離Ｌは、除圧に必要な体積（例えば、１ｍＬ程度）に相当する分だけヘッド部４２が後退できる距離に設定される。 In the use of the pharmaceutical injection tool 10C configured as described above, when the injection is suddenly stopped during the injection by the rotation operation of the pusher 122, the pusher 122 may be rotated in the reverse direction. Then, since the filling member 120 including the head portion 42 is retracted by the pressure from the medicine, the pressure in the system is surely released, so that the injection can be stopped suddenly and accurate injection can be ensured. In this case, in order to perform reliably decompression in the system, the distance L between the first convex portion 124 in a state where the head portion 42 and the head 31 is in contact with the second protrusion 126, required for depressurization The distance is set such that the head unit 42 can move backward by an amount corresponding to the volume (for example, about 1 mL).
　また、注入を急停止するために押し子１２２を逆回転させた際、第１凸部１２４と第２凸部１２６とが接触すると、押し子１２２の回転抵抗が増大する。このため、使用者は、除圧に必要な分だけ押し子１２２を逆回転させたことを容易に認識でき、必要以上に押し子１２２を逆回転させることがない。 Also, when the pusher 122 is reversely rotated to stop the injection suddenly, if the first convex portion 124 and the second convex portion 126 come into contact with each other, the rotational resistance of the pusher 122 increases. For this reason, the user can easily recognize that the pusher 122 has been reversely rotated by an amount necessary for pressure reduction, and the pusher 122 is not reversely rotated more than necessary.
　なお、第３実施形態において、第１実施形態と共通する各構成部分については、第１実施形態における当該共通の各構成部分がもたらす作用及び効果と同一又は同様の作用及び効果が得られることは勿論である。 In addition, in the third embodiment, with respect to each component common to the first embodiment, the same or similar operation and effect as the operation and effect brought about by each common component in the first embodiment can be obtained. Of course.
［第４実施形態］
　図１２は、本発明の第４実施形態に係る薬剤注入具１０Ｄの縦断面図である。薬剤注入具１０Ｄは、第１実施形態に係る薬剤注入具１０Ａと同様に、薬剤を所望の被注入空間に注入する際に薬剤を吐出するために使用する器具である。図１２に示すように、薬剤注入具１０Ｄは、筒状体１３０と、第１押し子１３２と、充填部材１３４と、第２押し子１３６と、ガイド部材１３８と、カバー部材１４０とを備える。薬剤注入具１０Ｄにおける筒状体１３０、ガイド部材１３８及びカバー部材１４０は、第１実施形態に係る薬剤注入具１０Ａにおける、ガイド部材３６及びカバー部材５２と同様に構成されている。 [Fourth Embodiment]
FIG. 12 is a longitudinal sectional view of a pharmaceutical injection device 10D according to the fourth embodiment of the present invention. Similarly to the drug injection tool 10A according to the first embodiment, the drug injection tool 10D is an instrument used for discharging a drug when the drug is injected into a desired injection space. As illustrated in FIG. 12, the drug injection device 10 </ b> D includes a cylindrical body 130, a first pusher 132, a filling member 134, a second pusher 136, a guide member 138, and a cover member 140. The cylindrical body 130, the guide member 138, and the cover member 140 in the drug injection device 10D are configured in the same manner as the guide member 36 and the cover member 52 in the drug injection device 10A according to the first embodiment.
　第１押し子１３２は、筒状体１３０の中空部に挿入可能なシャフト１４２と、シャフト１４２の基端に設けられ外方（半径方向外方）に拡径した中空状のハンドル１４４とを有する。この第１押し子１３２は、充填部材１３４に対して軸線方向に変位可能且つ周方向に相対回転可能である。 The first pusher 132 includes a shaft 142 that can be inserted into the hollow portion of the cylindrical body 130, and a hollow handle 144 that is provided at the proximal end of the shaft 142 and has an outer diameter (radially outward). . The first pusher 132 is displaceable in the axial direction with respect to the filling member 134 and is relatively rotatable in the circumferential direction.
　シャフト１４２は、第１実施形態における押し子１４のシャフト３０と同様に構成されている。ハンドル１４４は、シャフト１４２の基端から突出した第２押し子１３６を少なくとも部分的に覆うように基端方向に延在している。具体的には、ハンドル１４４は、シャフト１４２の基端部から半径方向外方に広がるフランジ部１４４ａと、フランジ部１４４ａの外端から基端方向に延出したカバー部１４４ｂとを有する。 The shaft 142 is configured in the same manner as the shaft 30 of the pusher 14 in the first embodiment. The handle 144 extends in the proximal direction so as to at least partially cover the second pusher 136 protruding from the proximal end of the shaft 142. Specifically, the handle 144 includes a flange portion 144a extending radially outward from the proximal end portion of the shaft 142, and a cover portion 144b extending from the outer end of the flange portion 144a in the proximal direction.
　ハンドル１４４（具体的には、カバー部１４４ｂ）には、シャフト１４２の軸線方向に沿って延在し且つ当該ハンドル１４４の基端方向に開放された切欠部１４６が設けられている。本実施形態において、切欠部１４６は、シャフト１４２の中心（軸線）を基準とした対称位置（１８０度位相がずれた位置）に２つ設けられている。 The handle 144 (specifically, the cover portion 144b) is provided with a notch portion 146 that extends along the axial direction of the shaft 142 and is opened in the proximal direction of the handle 144. In the present embodiment, two notches 146 are provided at symmetrical positions (positions that are 180 degrees out of phase) with respect to the center (axis) of the shaft 142.
　充填部材１３４を第１押し子１３２に対して基端方向に移動させるため、又は第２押し子１３６の前進により少量の薬剤を吐出させる際に、第２押し子１３６に対する引張り操作又押込み操作をし易いように、切欠部１４６は、使用者の指が挿入できる程度の大きさに形成されるのがよい。なお、ハンドル１４４には、第１実施形態におけるハンドル３２に設けられたような溝部４０（図１参照）は設けられていない。 When the filling member 134 is moved in the proximal direction with respect to the first pusher 132, or when a small amount of medicine is discharged by the advancement of the second pusher 136, the pulling operation or the push-in operation on the second pusher 136 is performed. In order to facilitate, the notch 146 is preferably formed to a size that allows a user's finger to be inserted. The handle 144 is not provided with the groove portion 40 (see FIG. 1) as provided in the handle 32 in the first embodiment.
　充填部材１３４は、薬剤吐出口１２ａを介して筒状体１３０内に薬剤を充填する際に基端方向に移動操作されることにより、薬剤を筒状体１３０内に吸引するためのデバイスであり、第１押し子１３２に対して軸線方向に変位可能に配置される。この充填部材１３４は、第１押し子１３２よりも先端側で筒状体１３０の中空部に液密に挿入されるヘッド部１４８と、ヘッド部１４８から基端方向に延出して第１押し子１３２のシャフト１４２の挿通孔１４２ａに挿通された軸部１５０とを有する。充填部材１３４は、第１実施形態における充填部材１３４に設けられたような把持部４５（図１等参照）が設けられない。 Filling member 134, by being operated to move proximally when filling the drug through the drug discharge port 12a the cylindrical body 130, be a device for sucking the drug in the cylindrical body 130 The first pusher 132 is arranged to be displaceable in the axial direction. The filling member 134 includes a head portion 148 that is liquid-tightly inserted into the hollow portion of the cylindrical body 130 on the tip side of the first pusher 132, and a first pusher that extends from the head portion 148 in the proximal direction. The shaft portion 150 is inserted into the insertion hole 142 a of the shaft 142 of the 132. The filling member 134 is not provided with the grip 45 (see FIG. 1 and the like) as provided in the filling member 134 in the first embodiment.
　ヘッド部１４８は、第１実施形態におけるヘッド部４２と同様に、外周部にシール部材１５２が装着される。シール部材１５２は筒状体１３０の内周面に密着するとともに、当該内周面に沿って軸線方向に液密に摺動可能である。軸部１５０は、第１押し子１３２のシャフト１４２よりも小径であり、シャフト１４２に設けられた挿通孔１４２ａ内に軸線方向に摺動可能に挿通され、第２押し子１３６を引っ張り操作した際の軸力を受けて、ヘッド部１４８に伝達するものである。本実施形態において、軸部１５０の全長は、シャフト１４２の全長と同程度である。 The head member 148 is provided with a seal member 152 on the outer peripheral portion in the same manner as the head member 42 in the first embodiment. The seal member 152 is in close contact with the inner peripheral surface of the cylindrical body 130 and is slidable in a liquid-tight manner in the axial direction along the inner peripheral surface. The shaft portion 150 is smaller in diameter than the shaft 142 of the first pusher 132, and is inserted into an insertion hole 142a provided in the shaft 142 so as to be slidable in the axial direction, and when the second pusher 136 is pulled. The axial force is received and transmitted to the head portion 148. In the present embodiment, the total length of the shaft portion 150 is approximately the same as the total length of the shaft 142.
　充填部材１３４には、ヘッド部１４８及び軸部１５０を軸線方向に貫通する貫通孔１３５が設けられる。この貫通孔１３５は、貫通孔１３５の先端側を構成する大径部１３５ａと、貫通孔１３５の基端側を構成する小径部１３５ｂとからなり、図示例では、大径部１３５ａと小径部１３５ｂとの境界部である段部１５４が、充填部材１３４の軸線方向の中間点付近に設けられる。 The filling member 134 is provided with a through hole 135 that penetrates the head portion 148 and the shaft portion 150 in the axial direction. The through-hole 135 includes a large-diameter portion 135a that forms the distal end side of the through-hole 135 and a small-diameter portion 135b that forms the proximal end side of the through-hole 135. In the illustrated example, the large-diameter portion 135a and the small-diameter portion 135b. Is provided in the vicinity of the intermediate point of the filling member 134 in the axial direction.
　第２押し子１３６は、規制された範囲内で軸線方向に変位自在に、充填部材１３４の貫通孔１３５に挿通されている。第２押し子１３６は、充填部材１３４の貫通孔１３５に摺動可能に挿通されたロッド１５６と、ロッド１５６の基端部に設けられた（取り付けられた）フランジ部１５８とを有する。 The second pusher 136 is inserted through the through-hole 135 of the filling member 134 so as to be displaceable in the axial direction within a restricted range. The second pusher 136 has a rod 156 slidably inserted into the through hole 135 of the filling member 134 and a flange portion 158 provided (attached) to the proximal end portion of the rod 156.
　ロッド１５６は、充填部材１３４の軸部１５０よりも細径に形成されている。ロッド１５６のうち、充填部材１３４に対して第２押し子１３６が最も基端側に変位した状態で充填部材１３４から基端側に突出する部分の外周面には、第１押し子１３２に対する軸線方向の位置（押し込み量、挿入量）を示す目盛りが一定間隔で設けられるとよい。当該目盛りは、使用者が視認できるものであれば特にその形態は限定されず、例えば、周方向に延在する溝で構成されてもよく、あるいはロッド１５６とは異なる色のインク（塗料）により表示されたものであってもよい。 The rod 156 is formed with a smaller diameter than the shaft portion 150 of the filling member 134. An axis of the rod 156 with respect to the first pusher 132 is disposed on the outer peripheral surface of a portion of the rod 156 that protrudes from the filling member 134 to the proximal end side with the second pusher 136 displaced to the most proximal side with respect to the filling member 134. Scales indicating the position in the direction (push amount, insertion amount) may be provided at regular intervals. The scale is not particularly limited as long as it can be visually recognized by the user. For example, the scale may be constituted by a groove extending in the circumferential direction, or may be made of ink (paint) having a color different from that of the rod 156. It may be displayed.
　ロッド１５６の先端側には、他の部分よりも外径が若干だけ拡大した拡径部１６０が形成されている。この拡径部１６０と、拡径部１６０よりも基端側の部位（以下、細径部１６１という）との外径差によって段部１６２が形成されている。第２押し子１３６は、拡径部１６０の基端側の端面（段部１６２）と、充填部材１３４の内周部に設けられた段部１５４とが当接する位置まで、充填部材１３４に対して基端側に移動することができる。 The enlarged diameter portion 160 whose outer diameter is slightly larger than the other portions is formed on the distal end side of the rod 156. A stepped portion 162 is formed by the outer diameter difference between the enlarged diameter portion 160 and a portion closer to the proximal end than the enlarged diameter portion 160 (hereinafter referred to as the narrow diameter portion 161). The second pusher 136 is located with respect to the filling member 134 until the end surface (stepped portion 162) on the proximal end side of the enlarged diameter portion 160 and the stepped portion 154 provided on the inner peripheral portion of the filling member 134 are in contact with each other. Can be moved to the base end side.
　ロッド１５６の拡径部１６０の外周部には、シール部材１５２が装着されている。このシール部材１５２は、充填部材１３４の軸部１５０の内周面に密着しつつ、当該内周面に沿って軸線方向に液密に摺動可能である。なお、このシール部材１５２は、図示例では、拡径部１６０の外周部に設けられたリング状の形態であるが、この形態に代えて、拡径部１６０の先端に装着された、例えば弾性樹脂材料からなるガスケットであってもよい。 A seal member 152 is attached to the outer peripheral portion of the enlarged diameter portion 160 of the rod 156. The seal member 152 can slide in a liquid-tight manner in the axial direction along the inner peripheral surface while being in close contact with the inner peripheral surface of the shaft portion 150 of the filling member 134. In the illustrated example, the seal member 152 is in the form of a ring provided on the outer peripheral portion of the enlarged diameter portion 160, but instead of this form, for example, an elastic member attached to the distal end of the enlarged diameter portion 160. A gasket made of a resin material may be used.
　充填部材１３４に対して第２押し子１３６が最も基端側に変位した状態での、第２押し子１３６よりも先端側の貫通孔１３５の内容積（すなわち、薬剤注入具１０Ｄに薬剤が充填された状態で、第２押し子１３６を充填部材１３４に対して最も基端側から最も先端側に移動させたときの第２押し子１３６による薬剤の吐出量）は、例えば、０．５～３ｍＬ程度に設定される。 When the second pusher 136 is displaced to the most proximal side with respect to the filling member 134, the inner volume of the through-hole 135 on the distal end side relative to the second pusher 136 (that is, the medicine filling device 10D is filled with the medicine) In this state, the amount of medicine discharged by the second pusher 136 when the second pusher 136 is moved from the most proximal side to the most distal side with respect to the filling member 134 is, for example, 0.5 to Set to about 3 mL.
　第２押し子１３６の先端部の外径は、例えば、２～７ｍｍ程度に設定され、３～６ｍｍ程度に設定されるのがより好ましい。第２押し子１３６の先端部の外径が大き過ぎると、高粘度の薬剤が充填された薬剤注入具１０Ｄの第２押し子１３６を押圧操作する際の操作力が大きくなり過ぎて、操作が難しくなる。また、第２押し子１３６の先端部の外径が小さ過ぎると、軸線方向の単位移動量当たりの排除容積（吐出量）が少なくなり過ぎる。 The outer diameter of the tip of the second pusher 136 is set to, for example, about 2 to 7 mm, and more preferably set to about 3 to 6 mm. If the outer diameter of the distal end portion of the second pusher 136 is too large, the operation force when pressing the second pusher 136 of the drug injection device 10D filled with the high-viscosity drug becomes too large, and the operation becomes difficult. It becomes difficult. If the outer diameter of the tip of the second pusher 136 is too small, the excluded volume (discharge amount) per unit movement amount in the axial direction is too small.
　フランジ部１５８は、第２押し子１３６を基端側に引っ張り操作する際、又は第２押し子１３６を先端側に押圧操作する際に、使用者が手指を引っ掛け、又は手指で押圧する部分であり、操作し易いように適度な大きさを有する。 The flange portion 158 is a portion that the user hooks or presses with a finger when the second pusher 136 is pulled toward the proximal end or when the second pusher 136 is pressed toward the distal end. There is an appropriate size for easy operation.
　第２押し子１３６は、フランジ部１５８の先端面と、充填部材１３４の基端面とが当接する位置まで、充填部材１３４に対して移動することができる。図示した構成例では、第２押し子１３６が充填部材１３４に対して最も先端側に移動したとき、第２押し子１３６の最先端面は、充填部材１３４の最先端部と略一致する。 The second pusher 136 can move with respect to the filling member 134 to a position where the distal end surface of the flange portion 158 and the proximal end surface of the filling member 134 come into contact with each other. In the illustrated configuration example, when the second pusher 136 moves to the most distal side with respect to the filling member 134, the foremost surface of the second pusher 136 substantially coincides with the foremost portion of the filling member 134.
　次に、上記のように構成された薬剤注入具１０Ｄに、薬剤の一例としての骨セメント８６を充填する方法を説明する。図１３Ａに示すように、骨セメント８６を充填するために、薬剤注入具１０Ｄを、第１押し子１３２及び充填部材１３４が筒状体１３０内に挿入され且つカバー部材１４０とガイド部材１３８とが連結された状態にする。この場合、第１押し子１３２はその可動範囲の最も基端側に移動させておき、充填部材１３４はその可動範囲の最も先端側に移動させておく。次に、吸引ポート８０を筒状体１３０のロック部２８に螺合して装着し、吸引ポート８０の先端を骨セメント８６に埋没させる。筒状体１３０に対する吸引ポート８０の装着は、カバー部材１４０とガイド部材１３８とを連結する前に実施してもよい。 Next, a method of filling the bone cement 86 as an example of the drug into the drug injection device 10D configured as described above will be described. As shown in FIG. 13A, in order to fill the bone cement 86, the drug injecting device 10D is inserted into the cylindrical body 130 with the first pusher 132 and the filling member 134, and the cover member 140 and the guide member 138 are connected. Keep connected. In this case, the first pusher 132 is moved to the most proximal side of the movable range, and the filling member 134 is moved to the most distal side of the movable range. Next, the suction port 80 is screwed and attached to the lock portion 28 of the cylindrical body 130, and the tip of the suction port 80 is buried in the bone cement 86. The suction port 80 may be attached to the cylindrical body 130 before the cover member 140 and the guide member 138 are connected.
　次に、図１３Ｂに示すように、骨セメント８６に吸引ポート８０の先端部を埋没させた状態で、第２押し子１３６を基端方向に引っ張る。そうすると、第２押し子１３６と充填部材１３４とは、段部１５４、１６２（図１２参照）の部分で係合しているため、第２押し子１３６の移動に伴って充填部材１３４が引っ張り上げられる。充填部材１３４の上昇（後退）に伴って、骨セメント８６が吸引ポート８０及び先端管部２０を介して筒状体１３０内に吸引される。これにより、骨セメント８６が筒状体１３０内に充填される。筒状体１３０内への骨セメント８６の充填量は、例えば、５～２０ｍＬ程度である。 Next, as shown in FIG. 13B, the second pusher 136 is pulled in the proximal direction in a state where the distal end portion of the suction port 80 is buried in the bone cement 86. Then, since the second pusher 136 and the filling member 134 are engaged at the step portions 154 and 162 (see FIG. 12), the filling member 134 is pulled up with the movement of the second pusher 136. It is done. As the filling member 134 rises (retreats), the bone cement 86 is sucked into the cylindrical body 130 through the suction port 80 and the distal end tube portion 20. Thereby, the bone cement 86 is filled in the cylindrical body 130. The filling amount of the bone cement 86 in the cylindrical body 130 is, for example, about 5 to 20 mL.
　この場合、筒状体１３０内において、充填部材１３４の先端側には、若干のエアが存在するため、次に、筒状体１３０内のエアを抜くエア排出作業を行う。エア排出作業では、薬剤注入具１０Ｄの先端を上方に向け、その状態でしばらく待機すると、骨セメント８６内でエアが徐々に上昇していき、最終的には、骨セメント８６の上方へと出ていく。 In this case, in the cylindrical body 130, a slight amount of air is present on the leading end side of the filling member 134. Next, an air discharging operation for extracting the air in the cylindrical body 130 is performed. In the air discharge operation, the tip of the medicine injection tool 10D is turned upward, and after waiting for a while in this state, the air gradually rises in the bone cement 86, and finally comes out above the bone cement 86. To go.
　骨セメント８６の上方からエアが抜けたら、次に、筒状体１３０に対して押し子１４を周方向に回転させて前進させると、第１押し子１３２の先端面が充填部材１３４のヘッド部１４８の基端面に当接し、第１押し子１３２によって充填部材１３４が押し上げられる（前進させられる）。そして、図１３Ｃに示すように、骨セメント８６の充填終了時に存在していたエアの体積に相当する分だけ充填部材１３４を前進させることにより、筒状体１３０内からエアを完全に排出することができる。 When the air escapes from above the bone cement 86, when the pusher 14 is rotated forward in the circumferential direction with respect to the cylindrical body 130, the distal end surface of the first pusher 132 becomes the head portion of the filling member 134. The filling member 134 is pushed up (advanced) by the first pusher 132 in contact with the base end surface of 148. Then, as shown in FIG. 13C, the air is completely discharged from the cylindrical body 130 by moving the filling member 134 forward by an amount corresponding to the volume of air existing at the end of filling the bone cement 86. Can do.
　次に、骨セメント８６を充填した薬剤注入具１０Ｄの操作方法について、当該薬剤注入具１０Ｄを用いて経皮的椎体形成術を実施する場合を例に挙げて説明する。 Next, an operation method of the drug injection device 10D filled with the bone cement 86 will be described taking as an example a case where a percutaneous vertebroplasty is performed using the drug injection device 10D.
　図１４Ａに示すように、骨セメント８６が充填された薬剤注入具１０Ｄの筒状体１３０と、骨セメント注入針９２の注入ポート９４とを、延長チューブ８８を介して連結した状態で、Ｘ線透視下で薬剤注入具１０Ｄに充填された骨セメント８６を吐出し、骨９０内に注入する。 As shown in FIG. 14A, in the state where the tubular body 130 of the drug injection device 10D filled with the bone cement 86 and the injection port 94 of the bone cement injection needle 92 are connected via the extension tube 88, the X-ray Under the fluoroscopy, the bone cement 86 filled in the drug injection device 10D is discharged and injected into the bone 90.
　この注入操作に際して、第１の使用方法では、先ず、第１押し子１３２を回転操作して、充填部材１３４を筒状体１３０に対して先端側に移動させていく。そうすると、充填部材１３４の筒状体１３０に対する先端側への移動に伴って、筒状体１３０内の充填室が高圧に加圧され、骨セメント８６が先端管部２０、延長チューブ８８及び骨セメント注入針９２を介して骨９０内に注入される。この場合、第１押し子１３２を回転操作することに伴って、第２押し子１３６が骨セメント８６から圧力を受けるため、第２押し子１３６は第１押し子１３２に対して基端側に移動する。 In this injection operation, in the first usage method, first, the first pusher 132 is rotated, and the filling member 134 is moved to the distal end side with respect to the cylindrical body 130. Then, as the filling member 134 moves toward the distal end side with respect to the tubular body 130, the filling chamber in the tubular body 130 is pressurized to a high pressure, and the bone cement 86 is moved to the distal end pipe portion 20, the extension tube 88, and the bone cement. It is injected into the bone 90 via the injection needle 92. In this case, since the second pusher 136 receives pressure from the bone cement 86 as the first pusher 132 is rotated, the second pusher 136 is brought to the proximal end side with respect to the first pusher 132. Moving.
　充填部材１３４の先端側への移動は、第１押し子１３２に対する回転操作によって行うことができることから、比較的小さな操作力で骨セメント８６を注入でき、しかも、充填部材１３４のヘッド部１４８は比較的大径であるため、比較的多くの骨セメント８６を迅速に注入することが可能である。第１押し子１３２の１回転あたりの骨セメント８６の注入量は、所定量（例えば、０．２５～２ｍＬ）に設定してもよい。 Since the movement of the filling member 134 toward the distal end side can be performed by rotating the first pusher 132, the bone cement 86 can be injected with a relatively small operation force, and the head portion 148 of the filling member 134 is compared. Due to the large diameter, a relatively large amount of bone cement 86 can be injected quickly. The injection amount of the bone cement 86 per rotation of the first pusher 132 may be set to a predetermined amount (for example, 0.25 to 2 mL).
　第１押し子１３２に対する回転操作によって骨セメント８６を大よその目標注入量まで注入したら、次に、図１４Ｂに示すように、第２押し子１３６を押圧操作して、第１押し子１３２及び充填部材１３４に対して先端側に移動させていく。そうすると、第２押し子１３６の第１押し子１３２及び充填部材１３４に対する先端側への移動に伴って、筒状体１３０内の充填室が高圧に加圧され、骨セメント８６が先端管部２０、延長チューブ８８及び骨セメント注入針９２を介して骨９０内に注入される。この第２押し子１３６の押圧操作により、骨セメント８６を目標注入量まで注入する。第２押し子１３６は、充填部材１３４のヘッド部１４８よりも小径であることから、小さな操作力で高圧を発生できるとともに、精密な注入が可能である。第２押し子１３６の最大注入量を所定量（例えば、０．５～３ｍＬ）に設定してもよい。 Once the bone cement 86 has been injected up to the approximate target injection amount by rotating the first pusher 132, then, as shown in FIG. 14B, the second pusher 136 is pushed and the first pusher 132 and It moves to the front end side with respect to the filling member 134. Then, as the second pusher 136 moves toward the distal end side with respect to the first pusher 132 and the filling member 134, the filling chamber in the cylindrical body 130 is pressurized to a high pressure, and the bone cement 86 is moved to the distal end pipe portion 20. The bone 90 is injected through the extension tube 88 and the bone cement injection needle 92. By pressing the second pusher 136, the bone cement 86 is injected up to the target injection amount. Since the second pusher 136 has a smaller diameter than the head portion 148 of the filling member 134, a high pressure can be generated with a small operating force, and precise injection can be performed. The maximum injection amount of the second pusher 136 may be set to a predetermined amount (for example, 0.5 to 3 mL).
　第２押し子１３６の押圧操作による注入の最中に、注入を急停止したい場合には、第２押し子１３６に対する押圧操作を停止すればよい。そうすると、骨セメント８６からの基端方向への押圧力により第２押し子１３６が第１押し子１３２及び充填部材１３４に対して後退することで、系内の圧力が確実に開放されるため、注入を確実に急停止でき、精密な注入を担保できる。 When the injection is suddenly stopped during the injection by the pressing operation of the second pusher 136, the pressing operation on the second pusher 136 may be stopped. Then, the pressure in the system is reliably released by the second pusher 136 moving backward with respect to the first pusher 132 and the filling member 134 by the pushing force in the proximal direction from the bone cement 86. The injection can be stopped suddenly and accurate injection can be guaranteed.
　次に、図１５Ａ～図１６Ｂを参照し、薬剤注入具１０Ｄの第２の使用方法（操作方法）について説明する。第２の使用方法では、第１の使用方法と同様に、まず、薬剤注入具１０Ｄに骨セメント８６を充填する。図１５Ａに示すように、第２の使用方法では、第１押し子１３２に対する回転操作によって骨セメント８６が吐出することを防止するため、活栓１７０を用いることが好ましい。 Next, a second usage method (operation method) of the pharmaceutical injection device 10D will be described with reference to FIGS. 15A to 16B. In the second usage method, as in the first usage method, first, the bone cement 86 is filled into the drug injection device 10D. As shown in FIG. 15A, in the second usage method, it is preferable to use a stopcock 170 in order to prevent the bone cement 86 from being discharged by a rotation operation on the first pusher 132.
　この活栓１７０は、第１ポート１７２と、第２ポート１７４と、コック１７６を有し、コック１７６を回動操作することで、第１ポート１７２と第２ポート１７４との間の通路が連通する開通状態と、第１ポート１７２と第２ポート１７４との間の通路が遮断される閉塞状態とを選択的に切り替えることができる二方活栓として構成されている。 The stopcock 170 has a first port 172, a second port 174, and a cock 176. By rotating the cock 176, the passage between the first port 172 and the second port 174 communicates. It is configured as a two-way stopcock that can selectively switch between an open state and a closed state in which the passage between the first port 172 and the second port 174 is blocked.
　このような活栓１７０は、延長チューブ８８の、骨セメント注入針９２に接続される側の端部と、薬剤注入具１０Ｄに接続される側の端部のいずれに設けてもよいが、図１５Ａ等に示すように、薬剤注入具１０Ｄに接続される側の端部に設けられると、骨セメント８６の注入時にＸ線照射領域の外で活栓１７０のコック１７６に対する回動操作を行うことができ、Ｘ線の被曝を好適に回避することができる。 Such a stopcock 170 may be provided at either the end of the extension tube 88 on the side connected to the bone cement injection needle 92 or the end on the side connected to the drug injection tool 10D. As shown in the above, when provided at the end of the side connected to the drug injection device 10D, the cock 176 of the stopcock 170 can be rotated outside the X-ray irradiation area when the bone cement 86 is injected. X-ray exposure can be preferably avoided.
　このような状態で、Ｘ線透視下で薬剤注入具１０Ｄに充填された骨セメント８６を吐出し、骨９０内に注入する。この注入操作に際して、第２の使用方法では、先ず、図１５Ｂに示すように、活栓１７０を開放状態としたうえで、第２押し子１３６を押圧操作して、第２押し子１３６を筒状体１３０に対して先端側に移動させていく。そうすると、第２押し子１３６の第１押し子１３２及び充填部材１３４に対する先端側への移動に伴って、筒状体１３０内の充填室が高圧に加圧され、骨セメント８６が先端管部２０、延長チューブ８８及び骨セメント注入針９２を介して骨９０内に注入される。第２押し子１３６は充填部材１３４のヘッド部１４８よりも小径であることから、小さな操作力で高圧を発生できるとともに、精密な注入が可能である。 In such a state, the bone cement 86 filled in the drug injection device 10D is discharged and injected into the bone 90 under X-ray fluoroscopy. At the time of this injection operation, in the second usage method, first, as shown in FIG. 15B, after the stopcock 170 is opened, the second pusher 136 is pressed to make the second pusher 136 cylindrical. The body 130 is moved toward the tip side. Then, as the second pusher 136 moves toward the distal end side with respect to the first pusher 132 and the filling member 134, the filling chamber in the cylindrical body 130 is pressurized to a high pressure, and the bone cement 86 is moved to the distal end pipe portion 20. The bone 90 is injected through the extension tube 88 and the bone cement injection needle 92. Since the second pusher 136 has a smaller diameter than the head portion 148 of the filling member 134, high pressure can be generated with a small operating force, and precise injection is possible.
　次に、図１６Ａに示すように、コック１７６を回転操作して活栓１７０を閉塞状態としてから、第１押し子１３２を回転操作して、第１押し子１３２を筒状体１３０に対して先端側に移動させる。このとき、骨セメント８６から受ける圧力により、第２押し子１３６が第１押し子１３２及び充填部材１３４に対して基端側に移動する。また、この場合、骨セメント８６は活栓１７０により薬剤注入具１０Ｄからの吐出が阻止されていることから、第１押し子１３２の回転操作に伴って骨セメント８６が薬剤注入具１０Ｄから吐出されることがない。第１押し子１３２に対する回転操作は、第２押し子１３６が最も基端側の位置に後退するまで行う。 Next, as shown in FIG. 16A, the cock 176 is rotated to close the stopcock 170, and then the first pusher 132 is rotated to bring the first pusher 132 to the tip of the cylindrical body 130. Move to the side. At this time, due to the pressure received from the bone cement 86, the second pusher 136 moves to the proximal end side with respect to the first pusher 132 and the filling member 134. Further, in this case, since the bone cement 86 is prevented from being discharged from the drug injection tool 10D by the stopcock 170, the bone cement 86 is discharged from the drug injection tool 10D as the first pusher 132 is rotated. There is nothing. The rotation operation with respect to the first pusher 132 is performed until the second pusher 136 is retracted to the most proximal position.
　次に、図１６Ｂに示すように、活栓１７０を開通状態としてから、第２押し子１３６を押圧操作して、骨セメント８６を骨９０内に注入する。その後、図１６Ａの場合と同様に、第１押し子１３２を再び回転操作して第２押し子１３６を元の位置に復帰させる。 Next, as shown in FIG. 16B, after the stopcock 170 is opened, the second pusher 136 is pressed to inject the bone cement 86 into the bone 90. Thereafter, similarly to the case of FIG. 16A, the first pusher 132 is rotated again to return the second pusher 136 to the original position.
　以上のように、第２の使用方法では、第２押し子１３６の先端側への押し込みにより少量を注入する操作を行った後に、第１押し子１３２を回転操作することで第２押し子１３６を元の位置に復帰させ、このような２つの操作を交互に複数回繰り返し、目標注入量の骨セメント８６を注入する。従って、すべての注入において精密な注入が可能である。特に、粘度が低い骨セメントを使用する際は、第１押し子１３２の押圧操作による筒状体１３０内の圧力上昇が不足し、第２押し子１３６を基部側へ後退させることが困難であるため活栓１７０を用いることが好ましい。 As described above, in the second usage method, the second pusher 136 is rotated by rotating the first pusher 132 after performing an operation of injecting a small amount by pushing the second pusher 136 toward the distal end side. The two operations are alternately repeated a plurality of times to inject a target amount of bone cement 86. Therefore, precise injection is possible in all injections. In particular, when bone cement having a low viscosity is used, the pressure increase in the tubular body 130 due to the pressing operation of the first pusher 132 is insufficient, and it is difficult to move the second pusher 136 backward to the base side. Therefore, it is preferable to use the stopcock 170.
　なお、第２押し子１３６の押圧操作による注入の最中に、注入を急停止したい場合には、第２押し子１３６に対する押圧操作を停止すればよい。そうすると、系内の圧力が確実に開放されるため、注入を確実に急停止でき、精密な注入を担保できる。 In addition, what is necessary is just to stop the press operation with respect to the 2nd pusher 136, when you want to stop injection rapidly during the injection | pouring by the press operation of the 2nd pusher 136. FIG. Then, since the pressure in the system is surely released, the injection can be stopped suddenly and accurate injection can be ensured.
［その他の変形例］
　上述した第１～第４実施形態では、ガイド部材３６（１３８）とカバー部材５２（１４０）との結合構造は、ネジ嵌合であるが、これに限らず、その他の結合構造、例えば、カバー部材５２（１４０）の基端に外方に突出する係合片が設けられ、ガイド部材３６（１３８）に当該係合片に嵌合可能な溝部が設けられ、カバー部材５２（１４０）とガイド部材３６（１３８）との相対回転により係合片と溝部との係合及び係合解除が可能な構造を採用してもよい。 [Other variations]
In the first to fourth embodiments described above, the coupling structure of the guide member 36 (138) and the cover member 52 (140) is screw fitting, but is not limited to this, and other coupling structures, for example, a cover An engagement piece that protrudes outward is provided at the base end of the member 52 (140), and a groove portion that can be fitted to the engagement piece is provided in the guide member 36 (138), and the cover member 52 (140) and the guide are provided. You may employ | adopt the structure which can engage / release engagement with an engagement piece and a groove part by relative rotation with the member 36 (138).
　上述した実施形態では、カバー部材５２（１４０）とガイド部材３６（１３８）とが結合することにより、ガイド部材３６（１３８）が筒状体１２（１３０）に対して固定される構成を採用したが、これに限らず、ガイド部材３６（１３８）が直接、筒状体１２（１３０）に対して固定される構成を採用してもよい。 In the embodiment described above, a configuration is adopted in which the guide member 36 (138) is fixed to the cylindrical body 12 (130) by coupling the cover member 52 (140) and the guide member 36 (138). However, the configuration is not limited thereto, and a configuration in which the guide member 36 (138) is directly fixed to the cylindrical body 12 (130) may be employed.
　上記において、本発明について好適な実施形態を挙げて説明したが、本発明は前記実施形態に限定されるものではなく、本発明の要旨を逸脱しない範囲において、種々の改変が可能なことは言うまでもない。 In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.

Claims (9)

  1. 　内部に充填された薬剤を吐出する薬剤注入具（１０Ａ～１０Ｄ）であって、
    　先端に薬剤吐出口（１２ａ）を有し、前記薬剤が充填される筒状体（１２、１３０）と、
    　前記筒状体（１２、１３０）の中空部に挿入され、軸線方向に貫通する挿通孔を有する押し子（１４、１２２、１３２）と、
    　前記押し子（１４、１２２、１３２）の前記筒状体（１２、１３０）に対する回転に伴って前記押し子（１４、１２２、１３２）を前記筒状体（１２、１３０）に対して軸線方向に変位させる送りネジ構造（７０）と、
    　前記押し子（１４、１２２、１３２）よりも先端側で前記筒状体（１２、１３０）の中空部に液密に挿入されるヘッド部（４２、１４８）を有し、前記押し子（１４、１２２、１３２）に対して軸線方向に変位可能な充填部材（１６、１１０、１２０、１３４）と、を備え、
    　前記充填部材（１６、１１０、１２０、１３４）を前記筒状体（１２、１３０）に対して後退させることにより、前記筒状体（１２、１３０）内への前記薬剤の充填を行い、
    　前記押し子（１４、１２２、１３２）を回転操作して前進させて前記ヘッド部（４２、１４８）を先端方向に移動させることにより、前記筒状体（１２、１３０）内に充填された前記薬剤を前記薬剤吐出口（１２ａ）から吐出する、
    　ことを特徴とする薬剤注入具（１０Ａ～１０Ｄ）。     A drug injection device (10A to 10D) for discharging a drug filled inside,
    A cylindrical body (12, 130) having a medicine discharge port (12a) at the tip and filled with the medicine;
    A pusher (14, 122, 132) that is inserted into the hollow portion of the cylindrical body (12, 130) and has an insertion hole penetrating in the axial direction;
    As the pusher (14, 122, 132) rotates with respect to the cylindrical body (12, 130), the pusher (14, 122, 132) is axially oriented with respect to the cylindrical body (12, 130). A feed screw structure (70) displaced to
    A head portion (42, 148) that is liquid-tightly inserted into the hollow portion of the cylindrical body (12, 130) on the tip side of the pusher (14, 122, 132); 122, 132), and filling members (16, 110, 120, 134) that are axially displaceable,
    Retreating the filling member (16, 110, 120, 134) with respect to the tubular body (12, 130) to fill the tubular body (12, 130) with the medicine;
    The pusher (14, 122, 132) is rotated and moved forward to move the head portion (42, 148) in the distal direction, thereby filling the cylindrical body (12, 130). Discharging a drug from the drug discharge port (12a),
    A drug injection device (10A to 10D) characterized by the above.
  2. 　請求項１記載の薬剤注入具（１０Ａ～１０Ｄ）において、
    　前記押し子（１４、１２２、１３２）の先端部は先細り形状となっている、
    　ことを特徴とする薬剤注入具（１０Ａ～１０Ｄ）。     The medicine injection device (10A to 10D) according to claim 1,
    The tip of the pusher (14, 122, 132) is tapered.
    A drug injection device (10A to 10D) characterized by the above.
  3. 　請求項１記載の薬剤注入具（１０Ａ～１０Ｃ）において、
    　前記押し子（１４）は、前記筒状体（１２）に挿通されるシャフト（３０）を有し、
    　前記充填部材（１６、１１０、１２０）は、前記ヘッド部（４２）から基端方向に延出して前記シャフト（３０）の中空部に挿通された軸部（４４）を有し、
    　前記軸部（４４）は、軸線方向の途中位置で先端側の第１部位（４４Ａ）と基端側の第２部位（４４Ｂ）とに分離可能である、
    　ことを特徴とする薬剤注入具（１０Ａ～１０Ｃ）。     The medicine injection device (10A to 10C) according to claim 1,
    The pusher (14) has a shaft (30) inserted through the cylindrical body (12),
    The filling member (16, 110, 120) has a shaft portion (44) extending from the head portion (42) in the proximal direction and inserted through a hollow portion of the shaft (30),
    The shaft portion (44) is separable into a first portion (44A) on the distal end side and a second portion (44B) on the proximal end side at an intermediate position in the axial direction.
    A drug injection device (10A to 10C) characterized by the above.
  4. 　請求項３記載の薬剤注入具（１０Ａ～１０Ｃ）において、
    　前記軸部（４４）は、軸線方向の前記途中位置に脆弱部（４８）を有し、
    　前記第１部位（４４Ａ）と前記第２部位（４４Ｂ）とは、前記軸部（４４）に所定以上の曲げ応力が作用した際に前記脆弱部（４８）が破断することにより分離可能となっている、
    　ことを特徴とする薬剤注入具（１０Ａ～１０Ｃ）。     The medicine injection device (10A to 10C) according to claim 3,
    The shaft portion (44) has a fragile portion (48) at the midway position in the axial direction,
    The first part (44A) and the second part (44B) can be separated by breaking the fragile part (48) when a bending stress of a predetermined level or more is applied to the shaft part (44). ing,
    A drug injection device (10A to 10C) characterized by the above.
  5. 　請求項４記載の薬剤注入具（１０Ａ～１０Ｃ）において、
    　前記押し子（１４）は、前記シャフト（３０）の基端に設けられたハンドル（３２）を有し、
    　前記ハンドル（３２）には、前記充填部材（１６、１１０、１２０）の前記軸部（４４）が進入可能な溝部（４０）が設けられる、
    　ことを特徴とする薬剤注入具（１０Ａ～１０Ｃ）。     The medicine injection device (10A to 10C) according to claim 4,
    The pusher (14) has a handle (32) provided at the proximal end of the shaft (30),
    The handle (32) is provided with a groove (40) into which the shaft (44) of the filling member (16, 110, 120) can enter.
    A drug injection device (10A to 10C) characterized by the above.
  6. 　請求項４記載の薬剤注入具（１０Ａ～１０Ｃ）において、
    　前記充填部材（１６、１１０、１２０）は、前記軸部（４４）の基端に設けられた把持部（４５）を有し、
    　前記把持部（４５）の側部には、有底の凹部（５０）が設けられる、
    　ことを特徴とする薬剤注入具（１０Ａ～１０Ｃ）。     The medicine injection device (10A to 10C) according to claim 4,
    The filling member (16, 110, 120) has a grip portion (45) provided at a proximal end of the shaft portion (44),
    A bottomed concave portion (50) is provided on a side portion of the grip portion (45).
    A drug injection device (10A to 10C) characterized by the above.
  7. 　請求項３記載の薬剤注入具（１０Ｂ）において、
    　前記充填部材（１１０）は、軸線方向に沿って前記ヘッド部（４２）の先端面まで延在するエア排出路（１１２）を有し、
    　前記第２部位（４４Ｂ）が前記第１部位（４４Ａ）から分離した際、前記エア排出路（１１２）を介して、前記筒状体（１２）内と外気とが連通する、
    　ことを特徴とする薬剤注入具（１０Ｂ）。     The medicine injection device (10B) according to claim 3,
    The filling member (110) has an air discharge path (112) extending to the tip surface of the head portion (42) along the axial direction,
    When the second part (44B) is separated from the first part (44A), the inside of the cylindrical body (12) communicates with the outside air via the air discharge path (112).
    A drug injection device (10B) characterized by the above.
  8. 　請求項４記載の薬剤注入具（１０Ｃ）において、
    　前記軸部（４４）には、外方に突出した第１凸部（１２４）が設けられ、
    　前記シャフト（３０）には、内方に突出し且つ前記第１凸部（１２４）と係合可能な第２凸部（１２６）が設けられ、
    　前記充填部材（１２０）に所定以上の軸力が作用したとき、前記第１凸部（１２４）が前記第２凸部（１２６）を乗り越えることが可能であり、
    　前記押し子（１２２）に対して前記充填部材（１２０）を後退させる際において、前記第１凸部（１２４）と前記第２凸部（１２６）とが接触した時点で、前記脆弱部（４８）が前記シャフト（３０）の基端から外部に露出する、
    　ことを特徴とする薬剤注入具（１０Ｃ）。     The medicine injection device (10C) according to claim 4,
    The shaft portion (44) is provided with a first convex portion (124) protruding outward,
    The shaft (30) is provided with a second convex portion (126) projecting inwardly and engageable with the first convex portion (124),
    When a predetermined axial force or more acts on the filling member (120), the first convex portion (124) can get over the second convex portion (126),
    When the filling member (120) is moved backward with respect to the pusher (122), the fragile portion (48) is brought into contact with the first convex portion (124) and the second convex portion (126). ) Is exposed to the outside from the proximal end of the shaft (30),
    A drug injection device (10C) characterized by the above.
  9. 　請求項１記載の薬剤注入具（１０Ｄ）において、
    　前記押し子（１３２）は、第１押し子（１３２）であり、
    　前記充填部材（１３４）は、軸線方向に貫通する貫通孔を有し、
    　前記薬剤注入具（１０Ｄ）は、さらに、前記貫通孔に軸線方向に液密に摺動可能に挿通された第２押し子（１３６）を備える、
    　ことを特徴とする薬剤注入具（１０Ｄ）。     The drug injection device (10D) according to claim 1,
    The pusher (132) is a first pusher (132),
    The filling member (134) has a through-hole penetrating in the axial direction,
    The drug injection device (10D) further includes a second pusher (136) inserted in the through hole so as to be slidable liquid-tightly in the axial direction.
    A drug injection device (10D) characterized by the above.
PCT/JP2012/062699 2012-05-17 2012-05-17 Medical agent injection device WO2013171886A1 (en)

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