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WO2013171886A1 - Dispositif d'injection d'agent médical - Google Patents

Dispositif d'injection d'agent médical 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
English (en)
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/fr
Priority to PCT/JP2012/074831 priority patent/WO2013171922A1/fr
Priority to JP2014515454A priority patent/JP6023185B2/ja
Publication of WO2013171886A1 publication Critical patent/WO2013171886A1/fr

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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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif d'injection d'agent médical (10A) qui comprend un corps cylindrique (12) qui est rempli d'un agent médical, un piston (14) qui est introduit dans la section creuse du corps cylindrique (12) et un élément de remplissage (16) qui peut être déplacé dans la direction axiale par rapport au piston (14). L'élément de remplissage (16) a une section tête (42) qui est introduite dans la section creuse du corps cylindrique (12) de manière étanche aux liquides à une position plus proche de l'extrémité avant que le piston (14). L'agent médical est introduit dans le corps cylindrique (12) par déplacement de l'élément de remplissage (16) vers l'arrière par rapport au corps cylindrique (12), et l'agent médical introduit dans le corps cylindrique (12) est évacué par une ouverture d'évacuation d'agent médical (12a) par rotation et déplacement du piston (14) vers l'avant pour déplacer la section tête (42) vers l'extrémité avant.
PCT/JP2012/062699 2012-05-17 2012-05-17 Dispositif d'injection d'agent médical WO2013171886A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PCT/JP2012/062699 WO2013171886A1 (fr) 2012-05-17 2012-05-17 Dispositif d'injection d'agent médical
PCT/JP2012/074831 WO2013171922A1 (fr) 2012-05-17 2012-09-27 Dispositif d'injection d'agent médical
JP2014515454A JP6023185B2 (ja) 2012-05-17 2012-09-27 薬剤注入具

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2012/062699 WO2013171886A1 (fr) 2012-05-17 2012-05-17 Dispositif d'injection d'agent médical

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WO2013171886A1 true WO2013171886A1 (fr) 2013-11-21

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PCT/JP2012/074831 WO2013171922A1 (fr) 2012-05-17 2012-09-27 Dispositif d'injection d'agent médical

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016538959A (ja) * 2013-12-05 2016-12-15 フェイベル，ジョナサン 骨の癒合、安定化および／または固定化のためのシステム、方法および機器と使用するターゲティング装置

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT201700010432A1 (it) * 2017-01-31 2018-07-31 Accademind S R L Dispositivo di iniezione di cemento osseo
KR101904157B1 (ko) * 2017-06-13 2018-10-05 전북대학교병원 골 고정 보강 수술에 적합한 골 고정부재 및 이를 포함하는 시스템
EP3815639A1 (fr) * 2019-10-30 2021-05-05 Sulzer Mixpac AG Mécanisme de distribution et procédé de distribution de matériau à l'aide d'un mécanisme de distribution

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5628770A (en) * 1979-07-30 1981-03-20 Leveen Harry H Injector
JPH02193677A (ja) * 1988-10-03 1990-07-31 Ken Heimreid 計量／混合注射器
JPH0623054A (ja) * 1992-04-07 1994-02-01 C R Bard Inc 血管形成術の用途に適応される選択的に制御可能な膨張‐収縮装置
JP2009534087A (ja) * 2006-04-21 2009-09-24 セウォン セロンテック カンパニー リミテッド 注射器のピストンの操作装置
JP2010207379A (ja) * 2009-03-10 2010-09-24 Jms Co Ltd 注入器
JP2011072386A (ja) * 2009-09-29 2011-04-14 Terumo Corp 薬剤注入具

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5628770A (en) * 1979-07-30 1981-03-20 Leveen Harry H Injector
JPH02193677A (ja) * 1988-10-03 1990-07-31 Ken Heimreid 計量／混合注射器
JPH0623054A (ja) * 1992-04-07 1994-02-01 C R Bard Inc 血管形成術の用途に適応される選択的に制御可能な膨張‐収縮装置
JP2009534087A (ja) * 2006-04-21 2009-09-24 セウォン セロンテック カンパニー リミテッド 注射器のピストンの操作装置
JP2010207379A (ja) * 2009-03-10 2010-09-24 Jms Co Ltd 注入器
JP2011072386A (ja) * 2009-09-29 2011-04-14 Terumo Corp 薬剤注入具

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016538959A (ja) * 2013-12-05 2016-12-15 フェイベル，ジョナサン 骨の癒合、安定化および／または固定化のためのシステム、方法および機器と使用するターゲティング装置
JP2020039951A (ja) * 2013-12-05 2020-03-19 フェイベル，ジョナサン 骨の癒合、安定化および／または固定化のためのシステム、方法および機器と使用するターゲティング装置

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JP6023185B2 (ja) 2016-11-09
JPWO2013171922A1 (ja) 2016-01-07

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