WO2013141187A1 - Drug injection device - Google Patents

Drug injection device Download PDF

Info

Publication number
WO2013141187A1
WO2013141187A1 PCT/JP2013/057589 JP2013057589W WO2013141187A1 WO 2013141187 A1 WO2013141187 A1 WO 2013141187A1 JP 2013057589 W JP2013057589 W JP 2013057589W WO 2013141187 A1 WO2013141187 A1 WO 2013141187A1
Authority
WO
WIPO (PCT)
Prior art keywords
cylindrical body
cover member
injection device
drug injection
drug
Prior art date
Application number
PCT/JP2013/057589
Other languages
French (fr)
Japanese (ja)
Inventor
早川浩一
照屋雅和
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
Publication of WO2013141187A1 publication Critical patent/WO2013141187A1/en

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8819Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8822Equipment 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8825Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by syringe details

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 filler that hardens with time is injected through a bone biopsy needle inserted into a fractured vertebral body for a vertebral body compression fracture caused by osteoporosis or cancer.
  • 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. .
  • an injection puncture needle for puncturing bone and a drug injection device connected to the injection puncture needle directly or via a tube are used.
  • the drug injection device generally includes a cylindrical body having a discharge port at the tip and a pusher inserted into the cylindrical body. It is comprised so that the filled bone cement may be discharged from the discharge port provided in the front-end
  • the viscosity of bone cement is high, when performing the operation to advance the pusher to discharge the bone cement filled inside from the drug injecting device, the operator must The outer periphery is often gripped with fingers. In this case, when the body temperature is transmitted from the operator's finger through the tubular body to the bone cement filled in the tubular body, the viscosity of the thermosetting bone cement increases, and thus the pusher is required to advance. The operating force increases.
  • JP-T-2008-541945 For the purpose of maintaining the temperature of the contrast medium or the like filled in the syringe (preventing temperature drop), a configuration in which the outer periphery of the syringe is covered with a jacket is disclosed in JP-T-2008-541945, but JP-T-2008-541945 The configuration is aimed at suppressing the temperature drop by increasing the heat capacity of the container containing the medicine, and about suppressing the heat due to the body temperature of the operator's finger from being transmitted to the medicine. No consideration is given.
  • the filling of the bone cement into the cylindrical body is performed by, for example, an operator holding the cylindrical body with the base end opening facing upward, and the operator or another operator can use the cylindrical body. This is done by pouring bone cement into the body.
  • the prior art has not proposed a technique for making such filling work easier.
  • the present invention has been made in consideration of such problems, can suppress the transfer of the body temperature of the operator's fingers to the medicine in the cylindrical body, and can easily fill the cylindrical body with the medicine.
  • An object is to provide a drug injection device that can be performed.
  • the present invention is a drug injection device that discharges a drug filled inside, and has a drug discharge port provided at a distal end and an opening provided at a proximal end, A cylindrical body filled with the medicine, a pusher that is liquid-tightly inserted into the hollow portion of the cylindrical body and movable in the axial direction in the cylindrical body, and an operator's A cover member that covers the periphery of the cylindrical body in order to prevent body temperature from being transmitted to the medicine in the cylindrical body via fingers, the cover member facing the opening upward It is configured to be able to support the cylindrical body in a state where it is in a closed state.
  • the cover member since the periphery of the cylindrical body is covered with the cover member, it is possible to suppress body temperature from being transmitted to the drug in the cylindrical body via the operator's fingers during operation. The For this reason, the influence by heat being transmitted to a chemical
  • a gap along the circumferential direction of the cylindrical body may be formed between the cover member and the cylindrical body.
  • the gap formed between the cover member and the cylindrical body functions as a heat insulating layer, the transfer of heat from the user to the medicine in the cylindrical body can be effectively reduced.
  • the cover member includes a fitting portion that is fitted to an outer peripheral portion of the cylindrical body, and an enlarged-diameter portion having an inner diameter larger than an inner diameter of the fitting portion, and the cover An annular gap extending in the axial direction is formed between the inner peripheral surface of the enlarged diameter portion of the cover member and the outer peripheral surface of the cylindrical body in a state where the cylindrical body is inserted through the member. May be.
  • the cover member is axially displaceable with respect to the tubular body, and the cover member is displaced in the most proximal direction with respect to the tubular body. It is preferable that the tip of the body protrudes from the tip of the cover member.
  • the tip of the cylindrical body can be protruded from the cover member after the cylindrical body is filled with the drug, another member (a puncture needle or a tube for drug insertion) is connected to the cylindrical body. It's easy to do.
  • a guide member that is detachable from the cover member and that is inserted into the pusher in a screwed state is provided, and the guide member is connected to the cover member.
  • the cylindrical body and the cover member may be fixed so as not to be relatively displaceable in the axial direction.
  • the drug injection tool can be stably held when using the drug injection tool, and the operability is excellent.
  • the guide member has not only a function of guiding the movement of the pusher relative to the cylindrical body, but also a function of mutually fixing the cylindrical body and the cover member, the guide means and the connecting means are separated by separate parts. There is no need to configure, and the drug injection device can be configured simply.
  • a flange portion may be provided at the proximal end of the cylindrical body, and the flange portion may be sandwiched between the cover member and the guide member in the axial direction.
  • the cylindrical body and the cover member can be firmly fixed in a state where relative movement in the axial direction is prevented.
  • a rotation preventing means for preventing relative rotation in the circumferential direction of the cylindrical body and the cover member may be provided.
  • the cylindrical body can be prevented from being rotated even when the pusher is rotated.
  • the medicine injection device of the present invention it is possible to suppress the body temperature of the operator's finger from being transmitted to the medicine in the cylindrical body, and it is possible to easily perform the filling operation of the medicine into the cylindrical body.
  • FIG. 3A is a longitudinal cross-sectional view in the assembly state of the chemical injection tool shown in FIG. 3A is a cross-sectional view taken along the line IIIA-IIIA in FIG. 2
  • FIG. 3B is a perspective view showing a structure on the cover member side of the rotation preventing means according to the modification
  • FIG. 3C is a modification.
  • FIG. 4A is a first diagram illustrating a method of filling a cylindrical body with a medicine
  • FIG. 4B is a second diagram illustrating a method of filling a cylindrical body with a medicine
  • FIG. 4A is a first diagram illustrating a method of filling a cylindrical body with a medicine
  • FIG. 4B is a second diagram illustrating a method of filling a cylindrical body with a medicine
  • FIG. 5A is a first diagram illustrating a method for operating a drug injection device
  • FIG. 5B is a second diagram illustrating a method for operating a drug injection device.
  • FIG. 1 is an exploded perspective view showing a drug injection device 10 according to an 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 filled with a drug, a pusher 14 inserted into the cylindrical body 12, and a cover member that covers the periphery of the cylindrical body 12. 16.
  • 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 drug discharge port 12 a is provided at the distal end of the cylindrical body 12, and an opening 12 b is provided at the proximal end of the cylindrical body 12.
  • the opening 12b is referred to as a “base end opening 12b”.
  • 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 distal end portion of the body portion 18 concentrically with the distal end tube portion 20 and has an internal thread portion 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 80 (see FIG. 5A and the like) or a bone cement injection needle 72 described later.
  • the flange portion 22 in the illustrated example is circular, but may be oval, or may be a shape protruding outward in a partial range in the circumferential direction.
  • a filling chamber 26 for filling a medicine is formed by a space surrounded by the cylindrical body 12 and the pusher 14.
  • the constituent material of the cylindrical body 12 is not particularly limited.
  • polyolefin such as polypropylene, polyethylene, cyclic polyolefin, and polymethylpentene 1 polyester, nylon, polycarbonate, polymethyl methacrylate (PMMA), and polyetherimide (PEI).
  • PEI polyetherimide
  • It may be formed of a resinous material such as polyethersulfone, polyetheretherketone (PEEK), fluororesin, polyphenylene sulfide (PPS), polyacetal resin (POM), a metallic material such as stainless steel, glass or the like.
  • PES polyetheretherketone
  • PPS polyphenylene sulfide
  • POM polyacetal resin
  • metallic material such as stainless steel, glass or the like.
  • the constituent material of the cylindrical body 12 is substantially transparent in order to ensure internal visibility.
  • it is preferable that it has strength, elasticity and chemical resistance that can withstand high pressure.
  • the pusher 14 is inserted into the hollow portion of the cylindrical body 12.
  • a seal member 32 is attached to the head 30 which is the tip of the pusher 14.
  • an annular seal groove 34 extending in the circumferential direction is formed on the outer periphery of the head 30, and a ring-shaped seal member 32 (for example, a silicone O-ring or the like) is disposed in the seal groove 34.
  • a seal member 32 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.
  • a gasket made of an elastic resin material may be attached to the tip of the pusher 14.
  • a male screw portion 38 is formed along the axial direction in a certain range on the base end side of the head 30.
  • the outer diameter of the male screw portion 38 is smaller than the inner diameter of the body portion 18 of the cylindrical body 12.
  • a guide member 42 that can be connected to the cover member 16 is attached to the male screw portion 38.
  • a handle 40 (rotation operation portion) having a diameter expanded outward (radially outward) is provided at the proximal end portion of the pusher 14.
  • the handle 40 is a portion that the user grips (pinch) with fingers when rotating the pusher 14 with respect to the cylindrical body 12 about the axis, and is formed in a substantially cylindrical shape in the illustrated example. ing.
  • a plurality of grooves 41 are formed on the outer periphery of the handle 40 at intervals in the circumferential direction so as to prevent slipping when the user grips and rotates.
  • the shape of the handle 40 is not limited to a substantially cylindrical shape, and may be a wing shape that protrudes radially outward from the proximal end portion of the pusher 14 in opposite directions.
  • the constituent material of the pusher 14 can be selected from those exemplified as the constituent material of the cylindrical body 12 described above.
  • the constituent material of the seal member 32 is not particularly limited.
  • the cover member 16 has a cylindrical shape with both ends open, and the cylindrical body 12 can be inserted from the base end side.
  • the front end surface 16a of the cover member 16 is configured so that the cover member 16 can be placed on a horizontal plane in a standing state with the front end surface 16a facing downward (see FIG. 4A).
  • the front end surface 16 a of the cover member 16 is a flat surface perpendicular to the axis of the cover member 16.
  • the cover member 16 In the state where the cover member 16 and the guide member 42 are coupled, the cover member 16 is prevented from moving in the axial direction with respect to the cylindrical body 12. However, in the state where the cover member 16 and the guide member 42 are separated, the cover member 16 is covered. The member 16 can be displaced in the axial direction with respect to the cylindrical body 12.
  • the cover member 16 has a length that can substantially cover the cylindrical body 12.
  • the cover member 16 is positioned closest to the tubular body 12, that is, the tubular body 12 is inserted through the cover member 16 and the guide member 42 and the cover member 16 are connected (see FIG. 2), the tip of the cover member 16 protrudes in the tip direction from the parallel portion 18 a of the cylindrical body 12.
  • the distal end (tip tube portion 20) of the cylindrical body 12 is , Protruding from the tip of the cover member 16.
  • the cover member 16 includes a fitting portion 44 that fits (contacts) with the outer peripheral portion of the inserted tubular body 12, and a diameter-expanded portion 45 that has an inner diameter larger than the inner diameter of the fitting portion 44.
  • the fitting portion 44 is provided only in a predetermined range constituting the base end portion of the cover member 16 and has an inner diameter that is substantially the same as the outer diameter of the cylindrical body 12.
  • the enlarged diameter portion 45 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 16 and has an inner diameter larger than the outer diameter of the cylindrical body 12.
  • an annular gap 48 extending in the axial direction is formed between the inner peripheral surface of the cover member 16 and the outer peripheral surface of the cylindrical body 12. Is done. As will be described later, the gap 48 functions as a heat insulating layer.
  • the protrusion part which protrudes partially is provided in the outer peripheral part of the cylindrical body 12, or the inner peripheral part of the cover member 16, and the outer peripheral part of the cylindrical body 12 and the inner peripheral part of the enlarged diameter part 45 of the cover member 16 May be in partial contact. Even in this case, a gap 48 (air layer) is formed between the outer peripheral portion of the cylindrical body 12 and the inner peripheral portion of the enlarged diameter portion 45.
  • a constituent material of the cover member 16 it can select from what was illustrated as a constituent material of the cylindrical body 12 mentioned above.
  • the cover member 16 itself may be made of a heat insulating material such as foamed polystyrene.
  • the gap 48 may have a mesh structure or a beam structure.
  • a male screw portion 17 that can be screwed into the second female screw portion 54b of the guide member 42 is provided on the outer periphery of the base end portion of the cover member 16 (the outer periphery of the fitting portion 44).
  • the pusher 14 is inserted into the guide member 42 in a screwed state.
  • the guide member 42 includes a base portion 50 through which the first female screw portion 54a is formed, and a screw cylinder 52 that extends from the outer end of the base portion 50 in the distal direction and has a second female screw portion 54b formed on the inner periphery thereof.
  • the first female screw portion 54a can be screwed with the male screw portion 38 provided on the pusher 14.
  • the second female screw portion 54 b can be screwed with the male screw portion 17 provided on the cover member 16.
  • the rotation of the pusher 14 relative to the cylindrical body 12 is performed by the first female screw portion 54 a provided in the guide member 42 and the male screw portion 38 provided in the pusher 14. Accordingly, a feed screw structure 56 (see FIG. 2) for displacing the pusher 14 in the axial direction with respect to the cylindrical body 12 is configured.
  • a feed screw structure 56 for displacing the pusher 14 in the axial direction with respect to the cylindrical body 12 is configured.
  • As a constituent material of the guide member 42 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 42 (the front surface of the base portion 50 of the guide member 42) and the cover member 16 (of the cover member 16). And the base end surface).
  • the guide member 42 is fixed to the cylindrical body 12 so as not to be relatively movable in the axial direction. That is, in the present embodiment, the guide member 42 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 mutually fixing the cylindrical body 12 and the cover member 16.
  • FIG. 3A is a cross-sectional view taken along line IIIA-IIIA in FIG.
  • a rib-like projection 58 extending in parallel with the axis of the cylindrical body 12 is provided on the outer peripheral portion of the cylindrical body 12.
  • a groove 59 extending in parallel with the axis of the cover member 16 is provided on the inner peripheral portion of the cover member 16.
  • the protrusion 58 and the groove 59 constitute the rotation preventing means 60 for preventing the relative rotation in the circumferential direction between the cylindrical body 12 and the cover member 16.
  • the groove 59 may be provided on the cylindrical body 12 side, and the protrusion 58 may be provided on the cover member 16 side.
  • a rotation prevention means 60a is configured by a protrusion 61 provided on the base end surface of the cover member 16 and a groove 62 provided on the front surface of the flange portion 22 of the cylindrical body 12. With the base end surface of the cover member 16 and the front surface of the flange portion 22 in contact with each other, the protrusion 61 and the groove 62 engage with each other, thereby preventing relative rotation between the cylindrical body 12 and the cover member 16. .
  • the groove 62 may be provided on the base end surface of the cover member 16, and the protrusion 61 may be provided on the front surface of the flange portion 22.
  • a protrusion or groove is provided on the base end surface of the flange portion 22 of the cylindrical body 12, and a groove or protrusion is provided on the front surface of the base portion 50 of the guide member 42.
  • the drug injection device 10 is basically configured as described above, and the operation and effect thereof will be described below.
  • the cover member 16 in a state where the cylindrical body 12 is inserted is placed in an upright state on a horizontal surface (a work table or the like). Then, since the cylindrical body 12 is supported by the cover member 16, the cylindrical body 12 stops with the proximal end opening 12 b facing upward. That is, the cover member 16 functions as a stand that holds the cylindrical body 12 in an upright state.
  • a predetermined amount of bone cement 66 adjusted in advance and placed in the container 65 is poured into the cylindrical body 12 from above the cylindrical body 12 through the proximal end opening 12b.
  • the operator does not need to hold the cylindrical body 12 while pouring the bone cement 66 into the cylindrical body 12. For this reason, the injection
  • the pusher 14 with the guide member 42 attached is inserted into the cylindrical body 12 from the proximal end opening 12b. And the guide member 42 and the cover member 16 are screwed together and fixed to each other.
  • some air exists above the bone cement 66 (between the bone cement 66 and the pusher 14).
  • the air discharge operation work which extracts the air in the cylindrical body 12 is performed.
  • the tip of the medicine injection device 10 is turned upward, and the apparatus waits for a while. Then, the air gradually rises in the bone cement 66, and finally goes out above the bone cement. Then, by rotating the pusher 14 in the circumferential direction with respect to the cylindrical body 12 and moving it forward, the air can be completely discharged from the cylindrical body 12.
  • the tubular body 12 of the drug injection device 10 and the injection port 74 of the bone cement injection needle 72 pierced into the bone 70 to be injected with the bone cement 66 are connected via the extension tube 80.
  • the medicine injection tool 10 can be operated in a state where the hand of the operator (user) is retracted outside the X-ray irradiation region.
  • the bone cement injection needle 72 includes a hollow puncture needle 76 made of, for example, a metal material, and a handle 78 made of, for example, a resin material fixed to the proximal end portion of the puncture needle 76.
  • a hollow puncture needle 76 made of, for example, a metal material
  • a handle 78 made of, for example, a resin material fixed to the proximal end portion of the puncture needle 76.
  • An injection port 74 communicating with the lumen (hollow part) of the puncture needle 76 is provided at the upper part of the handle 78.
  • One end of the extension tube 80 is provided with a connector 82 that is detachably connected to the injection port 74, and the other end of the extension tube 80 is a connector that is detachable from the distal end tube portion 20 and the lock portion 28 of the cylindrical body 12. 84 is provided.
  • the extension tube 80 preferably has a configuration in which a thread such as Kevlar (registered trademark), nylon, polyphenylene sulfide, stainless steel or the like is wound around the flexible tube wall or on the outer surface in a net or coil shape from the viewpoint of pressure resistance.
  • a thread such as Kevlar (registered trademark), nylon, polyphenylene sulfide, stainless steel or the like
  • 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 80 is preferably set to about 200 to 500 mm so that the operator's (user's) hand can be surely retracted outside the X-ray irradiation region. Further, the distal end portion of the extension tube 80 may be angled.
  • the connector 82 provided at one end of the extension tube 80 is connected to the injection port 74 of the handle 78, and the connector 84 provided at the other end of the extension tube 80 is connected to the distal end tube portion of the cylindrical body 12. 20 and the lock portion 28.
  • the bone cement 66 filled in the drug injection device 10 is discharged and injected into the bone 70 under X-ray fluoroscopy.
  • the pusher 14 is moved to the distal end side with respect to the cylindrical body 12 by rotating the pusher 14.
  • the filling chamber 26 is pressurized to a high pressure, and the bone cement 66 moves the distal end pipe portion 20, the extension tube 80 and the bone cement injection needle 72.
  • the bone cement 66 is injected up to the target injection amount by such a rotation operation on the pusher 14.
  • the operator of the drug injection tool 10 holds the cylindrical body 12 with fingers, and the periphery of the cylindrical body 12 is covered with the cover member 16, and the cylindrical body 12, the cover member 16, Since the gap 48 formed between the two functions as a heat insulating layer, it is possible to suppress body temperature from being transmitted to the bone cement 66 in the tubular body 12 through the fingers of the operator during operation. Therefore, the bone cement 66 is suppressed from being heated by the body temperature of the operator, and the increase rate of the viscosity of the bone cement 66 in the cylindrical body 12 can be suppressed.
  • the extension tube 80 is used to avoid exposure to X-rays when injecting the bone cement 66 under fluoroscopy.
  • the bone cement 66 under CT fluoroscopy is used. May be omitted, and the distal end tube portion 20 of the cylindrical body 12 of the drug injector 10 and the injection port 74 of the bone cement injection needle 72 may be directly connected.
  • the body temperature is increased in the cylindrical body 12 through the fingers of the operator during operation. Transmission to the other drug (bone cement 66) is suppressed. For this reason, the influence by heat being transmitted to a chemical
  • the cover member 16 also functions as a stand for standing the cylindrical body 12, the operator can pour the drug from the proximal end opening 12b of the cylindrical body 12 without gripping the cylindrical body 12. Therefore, the filling operation of the medicine can be performed easily.
  • a gap 48 is formed between the cover member 16 and the cylindrical body 12 along the circumferential direction of the cylindrical body 12. Therefore, when the gap 48 functions as a heat insulating layer, heat transfer from the user to the medicine in the cylindrical body 12 can be more effectively reduced.
  • the cover member 16 can be displaced in the axial direction with respect to the tubular body 12, and the cover member 16 is displaced in the most proximal direction with respect to the tubular body 12.
  • the tip of the body 12 protrudes from the tip of the cover member 16.
  • another member such as a bone cement injection needle 72 is provided on the cylindrical body 12. Or it is easy to connect the extension tube 80.
  • the drug injection device 10 includes a guide member 42 that can be attached to and detached from the cylindrical body 12, and the pusher 14 is inserted in a screwed state, and the guide member 42 further includes the cylindrical body 12.
  • the cylindrical body 12 and the cover member 16 are fixed so that they cannot be displaced relative to each other in the axial direction. According to this configuration, by fixing and integrating the cover member 16 with respect to the cylindrical body 12, the drug injection tool 10 can be stably held when using the drug injection tool 10, and the operability is excellent.
  • the guide member 42 has not only a function of guiding the movement of the pusher 14 with respect to the cylindrical body 12 but also a function of mutually fixing the cylindrical body 12 and the cover member 16. It is not necessary to configure the medicine injection device 10 as individual parts, and the drug injection device 10 can be configured simply.
  • the cylindrical body 12 and the cover member 16 are axially disposed. It can be firmly fixed in a state in which relative movement is prevented.
  • the medicine injection device 10 includes the rotation preventing means 60 (60a) that prevents relative rotation of the cylindrical body 12 and the cover member 16 in the circumferential direction, the cover member 16 is gripped (the cover member 16). Even when the pusher 14 is rotated in a state where the rotation of the cylindrical body 12 is prevented, the cylindrical body 12 can be prevented from being rotated. For this reason, the extension tube 80 or the bone cement injection needle 72 connected to the tubular body 12 can be prevented from rotating with the rotation of the pusher 14, and the procedure is not hindered.
  • the “screw-in type” in which the pusher 14 is moved forward by rotating the pusher 14 with respect to the tubular body 12 is employed.
  • the present invention is not limited to this, and the tubular body.
  • the pusher 14 is slidable in the axial direction with respect to 12, and the pusher 14 is moved forward by pressing the pusher 14 against the cylindrical body 12 without rotating the pusher 14.
  • a “push-in type” may be employed.
  • the coupling structure between the guide member 42 and the cover member 16 is screw fitting.
  • the coupling structure is not limited to this, and other coupling structures, for example, project outward to the base end of the cover member 16.
  • An engagement piece is provided, and a groove portion that can be fitted to the engagement piece is provided in the guide member 42. By the relative rotation of the cover member 16 and the guide member 42, the engagement piece and the groove portion are engaged and disengaged. It is also possible to adopt a structure capable of
  • a configuration in which the guide member 42 is fixed to the cylindrical body 12 by coupling the cover member 16 and the guide member 42 is adopted.
  • a configuration that is fixed to the cylindrical body 12 may be employed.
  • a male screw portion is provided on the outer peripheral portion of the base end of the cylindrical body 12, and the second female screw portion 54b provided on the guide member 42 and the male screw portion are screwed together to form a cylindrical shape.
  • a guide member 42 is fixed to the body 12.

Abstract

A drug injection device (10), comprising: a cylindrical body (12) into which a drug is filled; a plunger (14) inserted in a liquid-tight manner into a hollow section of the cylindrical body (12); and a cover member (16) covering the surrounds of the cylindrical body (12). The cover member (16) suppresses the transmission of body heat, via the finger of an operator, to the drug inside the cylindrical body (12) during operation of the drug injection device (10). The cover member (16) is configured so as to be capable of supporting the cylindrical body (12) such that a base end opening (12b) of the cylindrical body (12) is facing upward.

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とも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) in which a filler that hardens with time is injected through a bone biopsy needle inserted into a fractured vertebral body for a vertebral body compression fracture caused by osteoporosis or cancer. 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. .
 骨セメントを骨内に注入するには、骨に穿刺する注入用穿刺針と、当該注入用穿刺針に直接に又はチューブを介して接続される薬剤注入具が用いられる。当該薬剤注入具は、一般に、先端に吐出口を有する筒状体と、筒状体に挿入される押し子とからなり、押し子を筒状体に対して前進させることで、筒状体内に充填された骨セメントが筒状体の先端に設けられた吐出口から吐出されるように構成される(例えば、特許第4257976号公報参照)。 In order to inject bone cement into bone, an injection puncture needle for puncturing bone and a drug injection device connected to the injection puncture needle directly or via a tube are used. The drug injection device generally includes a cylindrical body having a discharge port at the tip and a pusher inserted into the cylindrical body. It is comprised so that the filled bone cement may be discharged from the discharge port provided in the front-end | tip of a cylindrical body (for example, refer patent 4257976).
 骨セメントの粘性が高いことから、内部に充填された骨セメントを薬剤注入具から吐出させるために押し子を前進させる操作を行う際、確実な操作を行うために、操作者は筒状体の外周部を手指で把持することが多い。この場合、操作者の手指から筒状体を介して、筒状体内に充填された骨セメントに体温が伝達すると、熱硬化型の骨セメントの粘度が上昇するため、押し子の前進操作に要する操作力が大きくなる。シリンジ内に充填した造影剤等の薬剤の保温(温度低下防止)を目的として、シリンジ外周をジャケットで覆う構成が特表2008-541945号公報に開示されているが、特表2008-541945号公報の構成は、薬剤を収容する容器の熱容量を大きくすることで温度低下を抑制することを狙ったものであり、操作者の手指の体温による熱が薬剤に伝達されることを抑制することについては何ら考慮されていない。 Since the viscosity of bone cement is high, when performing the operation to advance the pusher to discharge the bone cement filled inside from the drug injecting device, the operator must The outer periphery is often gripped with fingers. In this case, when the body temperature is transmitted from the operator's finger through the tubular body to the bone cement filled in the tubular body, the viscosity of the thermosetting bone cement increases, and thus the pusher is required to advance. The operating force increases. For the purpose of maintaining the temperature of the contrast medium or the like filled in the syringe (preventing temperature drop), a configuration in which the outer periphery of the syringe is covered with a jacket is disclosed in JP-T-2008-541945, but JP-T-2008-541945 The configuration is aimed at suppressing the temperature drop by increasing the heat capacity of the container containing the medicine, and about suppressing the heat due to the body temperature of the operator's finger from being transmitted to the medicine. No consideration is given.
 ところで、骨セメントの筒状体内への充填は、例えば、筒状体を、その基端開口を上に向けた状態で作業者が把持し、当該作業者又は別の作業者が、その筒状体に骨セメントを流し入れることにより行われる。従来技術では、このような充填作業をより簡便にするための技術は提案されていない。 By the way, the filling of the bone cement into the cylindrical body is performed by, for example, an operator holding the cylindrical body with the base end opening facing upward, and the operator or another operator can use the cylindrical body. This is done by pouring bone cement into the body. The prior art has not proposed a technique for making such filling work easier.
 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、操作者の手指の体温が筒状体内の薬剤に伝達することを抑制でき、且つ薬剤の筒状体への充填作業を簡便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 consideration of such problems, can suppress the transfer of the body temperature of the operator's fingers to the medicine in the cylindrical body, and can easily fill the cylindrical body with the medicine. An object is to provide a drug injection device that can be performed.
 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、先端に設けられた薬剤吐出口と、基端に設けられた開口部を有し、前記薬剤が充填される筒状体と、前記筒状体の中空部に液密に挿入され、前記筒状体内を軸線方向に移動可能な押し子と、前記薬剤注入具の操作時に操作者の手指を介して体温が前記筒状体内の前記薬剤に伝達することを抑制するために、前記筒状体の周囲を覆うカバー部材と、を備え、前記カバー部材は、前記開口部を上方に向けた状態で前記筒状体を支持することが可能なように構成されることを特徴とする。 In order to achieve the above object, the present invention is a drug injection device that discharges a drug filled inside, and has a drug discharge port provided at a distal end and an opening provided at a proximal end, A cylindrical body filled with the medicine, a pusher that is liquid-tightly inserted into the hollow portion of the cylindrical body and movable in the axial direction in the cylindrical body, and an operator's A cover member that covers the periphery of the cylindrical body in order to prevent body temperature from being transmitted to the medicine in the cylindrical body via fingers, the cover member facing the opening upward It is configured to be able to support the cylindrical body in a state where it is in a closed state.
 上記のように構成された薬剤注入具によれば、筒状体の周囲がカバー部材で覆われるので、操作時に操作者の手指を介して体温が筒状体内の薬剤に伝達することが抑制される。このため、薬剤に熱が伝わることによる影響を低減することができる。また、カバー部材は、筒状体を立てるスタンドとしても機能するため、筒状体の基端開口から薬剤を流し入れる際に、作業者が筒状体を把持する必要がない。従って、薬剤の充填作業を簡便に行うことができる。 According to the drug injection device configured as described above, since the periphery of the cylindrical body is covered with the cover member, it is possible to suppress body temperature from being transmitted to the drug in the cylindrical body via the operator's fingers during operation. The For this reason, the influence by heat being transmitted to a chemical | medical agent can be reduced. Further, since the cover member also functions as a stand for standing the cylindrical body, it is not necessary for the operator to grip the cylindrical body when pouring the medicine from the proximal end opening of the cylindrical body. Therefore, the filling operation of the medicine can be performed easily.
 上記の薬剤注入具において、前記カバー部材と前記筒状体との間に、前記筒状体の周方向に沿う空隙が形成されるとよい。 In the above-described drug injecting device, a gap along the circumferential direction of the cylindrical body may be formed between the cover member and the cylindrical body.
 カバー部材と筒状体との間に形成される空隙が断熱層として機能することにより、使用者から筒状体内の薬剤への熱の伝達を効果的に低減することができる。 Since the gap formed between the cover member and the cylindrical body functions as a heat insulating layer, the transfer of heat from the user to the medicine in the cylindrical body can be effectively reduced.
 上記の薬剤注入具において、前記カバー部材は、前記筒状体の外周部に嵌合する嵌合部と、前記嵌合部の内径よりも大きい内径を有する拡径部とを有し、前記カバー部材に前記筒状体が挿通された状態で、前記カバー部材の前記拡径部の内周面と前記筒状体の外周面との間に、軸線方向に延在する環状の空隙が形成されてもよい。 In the above-described drug injection device, the cover member includes a fitting portion that is fitted to an outer peripheral portion of the cylindrical body, and an enlarged-diameter portion having an inner diameter larger than an inner diameter of the fitting portion, and the cover An annular gap extending in the axial direction is formed between the inner peripheral surface of the enlarged diameter portion of the cover member and the outer peripheral surface of the cylindrical body in a state where the cylindrical body is inserted through the member. May be.
 上記の薬剤注入具において、前記カバー部材は、前記筒状体に対して軸線方向に変位可能であり、前記カバー部材が前記筒状体に対して最も基端側に変位した状態で、前記筒状体の先端が前記カバー部材の先端から突出するとよい。 In the medicine injection tool, the cover member is axially displaceable with respect to the tubular body, and the cover member is displaced in the most proximal direction with respect to the tubular body. It is preferable that the tip of the body protrudes from the tip of the cover member.
 上記の構成によれば、筒状体に薬剤を充填した後に筒状体の先端をカバー部材から突出させることができるため、筒状体に他の部材(薬剤入用穿刺針又はチューブ)を接続しやすい。 According to the above configuration, since the tip of the cylindrical body can be protruded from the cover member after the cylindrical body is filled with the drug, another member (a puncture needle or a tube for drug insertion) is connected to the cylindrical body. It's easy to do.
 上記の薬剤注入具において、前記カバー部材に対して着脱可能であり、且つ前記押し子が螺合状態で挿通されるガイド部材を備え、前記ガイド部材が前記カバー部材に対して連結された状態で、前記筒状体と前記カバー部材とが軸線方向に相対変位不可能に固定されてもよい。 In the above-described drug injecting device, a guide member that is detachable from the cover member and that is inserted into the pusher in a screwed state is provided, and the guide member is connected to the cover member. The cylindrical body and the cover member may be fixed so as not to be relatively displaceable in the axial direction.
 上記の構成によれば、カバー部材を筒状体に対して固定し一体化することにより、薬剤注入具の使用時に、薬剤注入具を安定して把持でき、操作性に優れる。また、ガイド部材が、筒状体に対する押し子の移動をガイドする機能だけでなく、筒状体とカバー部材とを相互固定する機能をも備えるので、ガイド手段と連結手段とを別々の部品で構成する必要がなく、薬剤注入具を簡素に構成できる。 According to the above configuration, by fixing and integrating the cover member with respect to the cylindrical body, the drug injection tool can be stably held when using the drug injection tool, and the operability is excellent. In addition, since the guide member has not only a function of guiding the movement of the pusher relative to the cylindrical body, but also a function of mutually fixing the cylindrical body and the cover member, the guide means and the connecting means are separated by separate parts. There is no need to configure, and the drug injection device can be configured simply.
 上記の薬剤注入具において、前記筒状体の基端にフランジ部が設けられ、前記フランジ部が、前記カバー部材と前記ガイド部材とにより軸線方向に挟まれてもよい。 In the above-described drug injection device, a flange portion may be provided at the proximal end of the cylindrical body, and the flange portion may be sandwiched between the cover member and the guide member in the axial direction.
 上記の構成によれば、筒状体とカバー部材とを軸線方向の相対移動を阻止した状態でしっかりと固定することができる。 According to the above configuration, the cylindrical body and the cover member can be firmly fixed in a state where relative movement in the axial direction is prevented.
 上記の薬剤注入具において、前記筒状体と前記カバー部材の周方向の相対回転を阻止する回転防止手段を備えてもよい。 In the above-described drug injection device, a rotation preventing means for preventing relative rotation in the circumferential direction of the cylindrical body and the cover member may be provided.
 上記の構成によれば、押し子を回転させても、筒状体が連れ回ることを防止できる。 According to the above configuration, the cylindrical body can be prevented from being rotated even when the pusher is rotated.
 本発明の薬剤注入具によれば、操作者の手指の体温が筒状体内の薬剤に伝達することを抑制でき、且つ薬剤の筒状体への充填作業を簡便に行うことができる。 According to the medicine injection device of the present invention, it is possible to suppress the body temperature of the operator's finger from being transmitted to the medicine in the cylindrical body, and it is possible to easily perform the filling operation of the medicine into the cylindrical body.
本発明の一実施形態に係る薬剤注入具の分解斜視図である。It is a disassembled perspective view of the chemical injection device concerning one 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2におけるIIIA-IIIA線に沿った横断面図であり、図3Bは、変形例に係る回転防止手段のカバー部材側の構造を示す斜視図であり、図3Cは、変形例に係る回転防止手段の筒状体側の構造を示す斜視図である。3A is a cross-sectional view taken along the line IIIA-IIIA in FIG. 2, FIG. 3B is a perspective view showing a structure on the cover member side of the rotation preventing means according to the modification, and FIG. 3C is a modification. It is a perspective view which shows the structure by the side of the cylindrical body of the rotation prevention means which concerns on. 図4Aは、筒状体への薬剤の充填方法を説明する第1の図であり、図4Bは、筒状体への薬剤の充填方法を説明する第2の図であり、図4Cは、筒状体への薬剤の充填方法を説明する第3の図であり、図4Dは、筒状体への薬剤の充填方法を説明する第4の図である。4A is a first diagram illustrating a method of filling a cylindrical body with a medicine, FIG. 4B is a second diagram illustrating a method of filling a cylindrical body with a medicine, and FIG. It is the 3rd figure explaining the filling method of the medicine to a cylindrical body, and Drawing 4D is the 4th figure explaining the filling method of the medicine to a cylindrical body. 図5Aは、薬剤注入具の操作方法を説明する第1の図であり、図5Bは、薬剤注入具の操作方法を説明する第2の図である。FIG. 5A is a first diagram illustrating a method for operating a drug injection device, and FIG. 5B is a second diagram illustrating a method for operating a drug injection device.
 以下、本発明に係る薬剤注入具10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 pharmaceutical injection device 10 according to the present invention will be described with reference to the accompanying drawings.
 図1は、本発明の一実施形態に係る薬剤注入具10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。 FIG. 1 is an exploded perspective view showing a drug injection device 10 according to an 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に挿入される押し子14と、筒状体12の周囲を覆うカバー部材16とを備える。 As shown in FIGS. 1 and 2, the drug injection device 10 includes a cylindrical body 12 filled with a drug, a pusher 14 inserted into the cylindrical body 12, and a cover member that covers the periphery of the cylindrical body 12. 16.
 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の先端には、薬剤吐出口12aが設けられ、筒状体12の基端には、開口部12bが設けられる。以下、開口部12bを「基端開口12b」とよぶ。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. A drug discharge port 12 a is provided at the distal end of the cylindrical body 12, and an opening 12 b is provided at the proximal end of the cylindrical body 12. Hereinafter, the opening 12b is referred to as a “base end opening 12b”. 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80(図5A等参照)又は骨セメント注入針72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 distal end tube portion 20, a lock portion 28 that protrudes in the axial direction from the distal end portion of the body portion 18 concentrically with the distal end tube portion 20 and has an internal thread portion 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 80 (see FIG. 5A and the like) or a bone cement injection needle 72 described later.
 図示例のフランジ部22は円形であるが、楕円形であってもよく、あるいは、周方向の一部の範囲で外方に突出する形状でもよい。 The flange portion 22 in the illustrated example is circular, but may be oval, or may be a shape protruding outward in a partial range in the circumferential direction.
 上記のように構成された筒状体12の内部には、筒状体12及び押し子14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26(図2参照)が形成される。 In the cylindrical body 12 configured as described above, a filling chamber 26 (see FIG. 2) for filling a medicine is formed by a space surrounded by the cylindrical body 12 and the pusher 14.
 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, polyethylene, cyclic polyolefin, and polymethylpentene 1, polyester, nylon, polycarbonate, polymethyl methacrylate (PMMA), and polyetherimide (PEI). It may be formed of a resinous material such as polyethersulfone, polyetheretherketone (PEEK), fluororesin, polyphenylene sulfide (PPS), polyacetal resin (POM), a metallic material such as stainless steel, glass or the like. . 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の中空部に挿入されるものである。押し子14の先端部である頭部30には、シール部材32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34が頭部30の外周に形成され、シール溝34にリング状のシール部材32(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32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。なお、リング状のシール部材32の代わりに、押し子14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 pusher 14 is inserted into the hollow portion of the cylindrical body 12. A seal member 32 is attached to the head 30 which is the tip of the pusher 14. In the illustrated example, an annular seal groove 34 extending in the circumferential direction is formed on the outer periphery of the head 30, and a ring-shaped seal member 32 (for example, a silicone O-ring or the like) is disposed in the seal groove 34. Such a seal member 32 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. Instead of the ring-shaped seal member 32, a gasket made of an elastic resin material may be attached to the tip of the pusher 14.
 押し子14において、頭部30よりも基端側の一定範囲には、雄ネジ部38が軸線方向に沿って形成されている。この雄ネジ部38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38には、カバー部材16に連結可能なガイド部材42が取り付けられる。 In the pusher 14, a male screw portion 38 is formed along the axial direction in a certain range on the base end side of the head 30. The outer diameter of the male screw portion 38 is smaller than the inner diameter of the body portion 18 of the cylindrical body 12. A guide member 42 that can be connected to the cover member 16 is attached to the male screw portion 38.
 押し子14の基端部には、外方(半径方向外方)に拡径したハンドル40(回転操作部)が設けられている。このハンドル40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、図示例では、略円筒形に形成されている。使用者が把持して回転操作する際に滑りにくいように、ハンドル40の外周には、周方向に間隔をおいて複数の溝41が形成されている。なお、ハンドル40の形状は、略円筒形に限定されず、押し子14の基端部から半径方向外方に互いに反対方向に突出するウイング状であってもよい。 A handle 40 (rotation operation portion) having a diameter expanded outward (radially outward) is provided at the proximal end portion of the pusher 14. The handle 40 is a portion that the user grips (pinch) with fingers when rotating the pusher 14 with respect to the cylindrical body 12 about the axis, and is formed in a substantially cylindrical shape in the illustrated example. ing. A plurality of grooves 41 are formed on the outer periphery of the handle 40 at intervals in the circumferential direction so as to prevent slipping when the user grips and rotates. Note that the shape of the handle 40 is not limited to a substantially cylindrical shape, and may be a wing shape that protrudes radially outward from the proximal end portion of the pusher 14 in opposite directions.
 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。また、シール部材32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。 The constituent material of the pusher 14 can be selected from those exemplified as the constituent material of the cylindrical body 12 described above. The constituent material of the seal member 32 is not particularly limited. For example, olefin elastomers, styrene elastomers, polyester elastomers, polyurethane elastomers, vulcanized rubbers such as silicone rubber, butyl rubber, fluororubber, and fluororesin It may be formed of a coated material.
 カバー部材16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16の先端面16aは、先端面16aを下方に向けた起立状態で、カバー部材16を水平面上に置くことができる(図4A参照)ように構成される。本実施形態では、カバー部材16の先端面16aは、カバー部材16の軸線に対して垂直な平坦面である。 The cover member 16 has a cylindrical shape with both ends open, and the cylindrical body 12 can be inserted from the base end side. The front end surface 16a of the cover member 16 is configured so that the cover member 16 can be placed on a horizontal plane in a standing state with the front end surface 16a facing downward (see FIG. 4A). In the present embodiment, the front end surface 16 a of the cover member 16 is a flat surface perpendicular to the axis of the cover member 16.
 カバー部材16とガイド部材42とが結合した状態では、カバー部材16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16とガイド部材42とが分離した状態では、カバー部材16は、筒状体12に対して軸線方向に変位可能である。 In the state where the cover member 16 and the guide member 42 are coupled, the cover member 16 is prevented from moving in the axial direction with respect to the cylindrical body 12. However, in the state where the cover member 16 and the guide member 42 are separated, the cover member 16 is covered. The member 16 can be displaced in the axial direction with respect to the cylindrical body 12.
 カバー部材16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、カバー部材16が筒状体12に対して最も基端側に位置する状態、すなわち筒状体12がカバー部材16に挿通され且つガイド部材42とカバー部材16とが連結した状態(図2の状態)で、カバー部材16の先端が、筒状体12の平行部18aよりも先端方向に突出する。また、好ましくは、筒状体12がカバー部材16に挿通され且つガイド部材42とカバー部材16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16の先端から突出する。 The cover member 16 has a length that can substantially cover the cylindrical body 12. Preferably, the cover member 16 is positioned closest to the tubular body 12, that is, the tubular body 12 is inserted through the cover member 16 and the guide member 42 and the cover member 16 are connected (see FIG. 2), the tip of the cover member 16 protrudes in the tip direction from the parallel portion 18 a of the cylindrical body 12. In addition, preferably, in a state where the cylindrical body 12 is inserted through the cover member 16 and the guide member 42 and the cover member 16 are connected (the state shown in FIG. 2), the distal end (tip tube portion 20) of the cylindrical body 12 is , Protruding from the tip of the cover member 16.
 カバー部材16は、挿通された筒状体12の外周部に嵌合(接触)する嵌合部44と、嵌合部44の内径よりも大きい内径を有する拡径部45とを有する。嵌合部44は、カバー部材16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。拡径部45は、カバー部材16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16に筒状体12が挿通された状態では、カバー部材16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48が形成される。後述するように、この空隙48は、断熱層として機能する。 The cover member 16 includes a fitting portion 44 that fits (contacts) with the outer peripheral portion of the inserted tubular body 12, and a diameter-expanded portion 45 that has an inner diameter larger than the inner diameter of the fitting portion 44. The fitting portion 44 is provided only in a predetermined range constituting the base end portion of the cover member 16 and has an inner diameter that is substantially the same as the outer diameter of the cylindrical body 12. The enlarged diameter portion 45 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 16 and has an inner diameter larger than the outer diameter of the cylindrical body 12. For this reason, when the cylindrical body 12 is inserted through the cover member 16, an annular gap 48 extending in the axial direction is formed between the inner peripheral surface of the cover member 16 and the outer peripheral surface of the cylindrical body 12. Is done. As will be described later, the gap 48 functions as a heat insulating layer.
 なお、筒状体12の外周部又はカバー部材16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16の拡径部45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45の内周部との間に空隙48(空気層)が形成される。カバー部材16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16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48がメッシュ構造や梁構造を有するものでもよい。 In addition, the protrusion part which protrudes partially is provided in the outer peripheral part of the cylindrical body 12, or the inner peripheral part of the cover member 16, and the outer peripheral part of the cylindrical body 12 and the inner peripheral part of the enlarged diameter part 45 of the cover member 16 May be in partial contact. Even in this case, a gap 48 (air layer) is formed between the outer peripheral portion of the cylindrical body 12 and the inner peripheral portion of the enlarged diameter portion 45. As a constituent material of the cover member 16, it can select from what was illustrated as a constituent material of the cylindrical body 12 mentioned above. Further, the cover member 16 itself may be made of a heat insulating material such as foamed polystyrene. Further, the gap 48 may have a mesh structure or a beam structure.
 カバー部材16の基端部外周(嵌合部44の外周)にはガイド部材42の第2雌ネジ部54bに螺合可能な雄ネジ部17が設けられる。ガイド部材42には、押し子14が螺合状態で挿通される。ガイド部材42は、第1雌ネジ部54aが貫通形成された基部50と、基部50の外端から先端方向に延出し内周に第2雌ネジ部54bが形成されたネジ筒52とを有する。第1雌ネジ部54aは、押し子14に設けられた雄ネジ部38と螺合可能である。第2雌ネジ部54bは、カバー部材16に設けられた雄ネジ部17と螺合可能である。 A male screw portion 17 that can be screwed into the second female screw portion 54b of the guide member 42 is provided on the outer periphery of the base end portion of the cover member 16 (the outer periphery of the fitting portion 44). The pusher 14 is inserted into the guide member 42 in a screwed state. The guide member 42 includes a base portion 50 through which the first female screw portion 54a is formed, and a screw cylinder 52 that extends from the outer end of the base portion 50 in the distal direction and has a second female screw portion 54b formed on the inner periphery thereof. . The first female screw portion 54a can be screwed with the male screw portion 38 provided on the pusher 14. The second female screw portion 54 b can be screwed with the male screw portion 17 provided on the cover member 16.
 本実施形態に係る薬剤注入具10では、ガイド部材42に設けられた第1雌ネジ部54aと、押し子14に設けられた雄ネジ部38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56(図2参照)が構成されている。ガイド部材42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 pharmaceutical injection device 10 according to the present embodiment, the rotation of the pusher 14 relative to the cylindrical body 12 is performed by the first female screw portion 54 a provided in the guide member 42 and the male screw portion 38 provided in the pusher 14. Accordingly, a feed screw structure 56 (see FIG. 2) for displacing the pusher 14 in the axial direction with respect to the cylindrical body 12 is configured. As a constituent material of the guide member 42, it can select from what was illustrated as a constituent material of the cylindrical body 12 mentioned above.
 ガイド部材42とカバー部材16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42(ガイド部材42の基部50の前面)とカバー部材16(カバー部材16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42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42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16とを相互固定する連結手段としての機能をも備える。 In a state where the guide member 42 and the cover member 16 are connected by screw fitting, the flange portion 22 of the cylindrical body 12 is configured such that the guide member 42 (the front surface of the base portion 50 of the guide member 42) and the cover member 16 (of the cover member 16). And the base end surface). Thereby, the guide member 42 is fixed to the cylindrical body 12 so as not to be relatively movable in the axial direction. That is, in the present embodiment, the guide member 42 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 mutually fixing the cylindrical body 12 and the cover member 16. Prepare.
 図3Aは、図2におけるIIIA-IIIA線に沿った横断面図である。筒状体12の外周部には、筒状体12の軸線と平行に延在するリブ状の突起58が設けられる。カバー部材16の内周部には、カバー部材16の軸線と平行に延在する溝59が設けられる。突起58と溝59とが係合することにより、カバー部材16と筒状体12との相対回転が防止される。本実施形態では、突起58と溝59はそれぞれ2つずつ設けられるが、それぞれ1つ又は3つ以上でもよい。 FIG. 3A is a cross-sectional view taken along line IIIA-IIIA in FIG. A rib-like projection 58 extending in parallel with the axis of the cylindrical body 12 is provided on the outer peripheral portion of the cylindrical body 12. A groove 59 extending in parallel with the axis of the cover member 16 is provided on the inner peripheral portion of the cover member 16. When the protrusion 58 and the groove 59 are engaged with each other, the relative rotation between the cover member 16 and the cylindrical body 12 is prevented. In this embodiment, two protrusions 58 and two grooves 59 are provided, but one or three or more may be provided.
 このように本実施形態では、突起58と溝59とにより、筒状体12とカバー部材16の周方向の相対回転を防止する回転防止手段60が構成される。なお、筒状体12側に溝59が設けられ、カバー部材16側に突起58が設けられてもよい。 As described above, in the present embodiment, the protrusion 58 and the groove 59 constitute the rotation preventing means 60 for preventing the relative rotation in the circumferential direction between the cylindrical body 12 and the cover member 16. The groove 59 may be provided on the cylindrical body 12 side, and the protrusion 58 may be provided on the cover member 16 side.
 回転防止手段60に代えて、図3B及び図3Cに示すように、変形例に係る回転防止手段60aが設けられてもよい。この回転防止手段60aは、カバー部材16の基端面に設けられた突起61と、筒状体12のフランジ部22の前面に設けられた溝62とにより構成される。カバー部材16の基端面とフランジ部22の前面とが当接した状態で、突起61と溝62とが係合し、これにより、筒状体12とカバー部材16との相対回転が阻止される。なお、カバー部材16の基端面に溝62が設けられ、フランジ部22の前面に突起61が設けられてもよい。 Instead of the rotation prevention means 60, as shown in FIGS. 3B and 3C, a rotation prevention means 60a according to a modification may be provided. The rotation preventing means 60 a is configured by a protrusion 61 provided on the base end surface of the cover member 16 and a groove 62 provided on the front surface of the flange portion 22 of the cylindrical body 12. With the base end surface of the cover member 16 and the front surface of the flange portion 22 in contact with each other, the protrusion 61 and the groove 62 engage with each other, thereby preventing relative rotation between the cylindrical body 12 and the cover member 16. . The groove 62 may be provided on the base end surface of the cover member 16, and the protrusion 61 may be provided on the front surface of the flange portion 22.
 さらに別の変形例に係る回転防止手段として、筒状体12のフランジ部22の基端面に突起又は溝が設けられ、ガイド部材42の基部50の前面に溝又は突起が設けられ、フランジ部22側の突起又は溝と、基部50側の溝又は突起とが係合することにより、ガイド部材42を介して、筒状体12とカバー部材16との相対回転が阻止されてもよい。 As a rotation preventing means according to another modification, a protrusion or groove is provided on the base end surface of the flange portion 22 of the cylindrical body 12, and a groove or protrusion is provided on the front surface of the base portion 50 of the guide member 42. By engaging the protrusion or groove on the side and the groove or protrusion on the base 50 side, relative rotation between the cylindrical body 12 and the cover member 16 may be prevented via the guide member 42.
 本実施形態に係る薬剤注入具10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 10 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10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4Aに示すように、筒状体12が挿通された状態のカバー部材16を、水平面(作業台等)上に起立状態で載置する。すると、筒状体12は、カバー部材16により支持されているため、基端開口12bを上方に向けた状態で静止する。すなわち、カバー部材16は、筒状体12を起立状態に保持するスタンドとして機能する。 First, a method for filling the drug injection tool 10 with bone cement as an example of a drug will be described. As shown in FIG. 4A, the cover member 16 in a state where the cylindrical body 12 is inserted is placed in an upright state on a horizontal surface (a work table or the like). Then, since the cylindrical body 12 is supported by the cover member 16, the cylindrical body 12 stops with the proximal end opening 12 b facing upward. That is, the cover member 16 functions as a stand that holds the cylindrical body 12 in an upright state.
 次に、図4Bに示すように、事前に調整され容器65に入れられた骨セメント66を、筒状体12の上方から、基端開口12bを通して筒状体12内に所定量だけ流し入れる。このとき、筒状体12はカバー部材16により支持されて起立状態が保持されるため、筒状体12に骨セメント66を流し入れる間、作業者が筒状体12を把持する必要がない。このため、筒状体12内への骨セメント66の注入を簡便に行うことができる。 Next, as shown in FIG. 4B, a predetermined amount of bone cement 66 adjusted in advance and placed in the container 65 is poured into the cylindrical body 12 from above the cylindrical body 12 through the proximal end opening 12b. At this time, since the cylindrical body 12 is supported by the cover member 16 and maintained in an upright state, the operator does not need to hold the cylindrical body 12 while pouring the bone cement 66 into the cylindrical body 12. For this reason, the injection | pouring of the bone cement 66 in the cylindrical body 12 can be performed simply.
 筒状体12内に所定量の骨セメント66を注入したら、次に、図4Cに示すように、ガイド部材42が装着された状態の押し子14を、基端開口12bから筒状体12内に挿入するとともに、ガイド部材42とカバー部材16とを螺合させて相互固定する。この場合、筒状体12内において、骨セメント66の上方(骨セメント66と押し子14との間)には、若干の空気が存在する。筒状体12内に空気が混入した状態では、空気がダンパーとして作用することにより骨セメント66の吐出が困難となり、あるいは、骨セメント66を吐出できても応答性が悪く、骨セメント66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、筒状体12内の空気を抜くエアー排出作業を行う。 After a predetermined amount of bone cement 66 has been injected into the cylindrical body 12, next, as shown in FIG. 4C, the pusher 14 with the guide member 42 attached is inserted into the cylindrical body 12 from the proximal end opening 12b. And the guide member 42 and the cover member 16 are screwed together and fixed to each other. In this case, in the cylindrical body 12, some air exists above the bone cement 66 (between the bone cement 66 and the pusher 14). In a state where air is mixed in the cylindrical body 12, it becomes difficult to discharge the bone cement 66 due to the air acting as a damper, or even if the bone cement 66 can be discharged, the responsiveness is poor, and the bone of the bone cement 66 It becomes difficult to accurately control the amount injected into the inside. For this reason, the air discharge operation | work which extracts the air in the cylindrical body 12 is performed.
 エアー排出作業では、図4Dに示すように、薬剤注入具10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66内で空気が徐々に上昇していき、最終的には、骨セメントの上方へと出ていく。そして、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ことにより、筒状体12内から空気を完全に排出することができる。 In the air discharging operation, as shown in FIG. 4D, the tip of the medicine injection device 10 is turned upward, and the apparatus waits for a while. Then, the air gradually rises in the bone cement 66, and finally goes out above the bone cement. Then, by rotating the pusher 14 in the circumferential direction with respect to the cylindrical body 12 and moving it forward, the air can be completely discharged from the cylindrical body 12.
 次に、骨セメント66を充填した薬剤注入具10の操作方法について、当該薬剤注入具10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 10 filled with the bone cement 66 will be described taking as an example a case where a percutaneous vertebroplasty is performed using the drug injection device 10.
 図5Aに示すように、薬剤注入具10の筒状体12と、骨セメント66の注入対象である骨70に穿刺された骨セメント注入針72の注入ポート74とを、延長チューブ80を介して連結する。この延長チューブ80を用いることで、術者(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10を操作することが可能となる。 As shown in FIG. 5A, the tubular body 12 of the drug injection device 10 and the injection port 74 of the bone cement injection needle 72 pierced into the bone 70 to be injected with the bone cement 66 are connected via the extension tube 80. Link. By using the extension tube 80, the medicine injection tool 10 can be operated in a state where the hand of the operator (user) is retracted outside the X-ray irradiation region.
 ここで、骨セメント注入針72は、例えば、金属材料で構成された中空構造の穿刺針76と、穿刺針76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78とを有する。ハンドル78の上部には、穿刺針76の内腔(中空部)と連通した注入ポート74が設けられている。延長チューブ80の一端には、注入ポート74と着脱可能に連結するコネクタ82が設けられ、延長チューブ80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84が設けられている。 Here, the bone cement injection needle 72 includes a hollow puncture needle 76 made of, for example, a metal material, and a handle 78 made of, for example, a resin material fixed to the proximal end portion of the puncture needle 76. Have. An injection port 74 communicating with the lumen (hollow part) of the puncture needle 76 is provided at the upper part of the handle 78. One end of the extension tube 80 is provided with a connector 82 that is detachably connected to the injection port 74, and the other end of the extension tube 80 is a connector that is detachable from the distal end tube portion 20 and the lock portion 28 of the cylindrical body 12. 84 is provided.
 延長チューブ80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80の長さは、術者(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80の先端部分がアングル付けされているとよい。 The extension tube 80 preferably has a configuration in which a thread such as Kevlar (registered trademark), nylon, polyphenylene sulfide, stainless steel or the like is wound around the flexible tube wall or on the outer surface in a net or coil shape from the viewpoint of pressure resistance. 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 80 is preferably set to about 200 to 500 mm so that the operator's (user's) hand can be surely retracted outside the X-ray irradiation region. Further, the distal end portion of the extension tube 80 may be angled.
 図5Aでは、このような延長チューブ80の一端に設けられたコネクタ82がハンドル78の注入ポート74に連結され、延長チューブ80の他端に設けられたコネクタ84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. 5A, the connector 82 provided at one end of the extension tube 80 is connected to the injection port 74 of the handle 78, and the connector 84 provided at the other end of the extension tube 80 is connected to the distal end 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10に充填された骨セメント66を吐出し、骨70内に注入する。この注入操作では、図5B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を筒状体12に対して先端側に移動させていく。そうすると、押し子14の筒状体12に対する先端側への移動に伴って、充填室26が高圧に加圧され、骨セメント66が、先端管部20、延長チューブ80及び骨セメント注入針72を介して骨70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66を目標注入量まで注入する。 In such a state, the bone cement 66 filled in the drug injection device 10 is discharged and injected into the bone 70 under X-ray fluoroscopy. In this injection operation, as shown in FIG. 5B, the pusher 14 is moved to the distal end side with respect to the cylindrical body 12 by rotating the pusher 14. Then, as the pusher 14 moves toward the distal end side with respect to the cylindrical body 12, the filling chamber 26 is pressurized to a high pressure, and the bone cement 66 moves the distal end pipe portion 20, the extension tube 80 and the bone cement injection needle 72. And injected into the bone 70. The bone cement 66 is injected up to the target injection amount by such a rotation operation on the pusher 14.
 注入操作を行う間、薬剤注入具10の操作者は、筒状体12を手指で把持するが、筒状体12の周囲がカバー部材16で覆われるとともに、筒状体12とカバー部材16との間に形成された空隙48が断熱層として機能するため、操作時に操作者の手指を介して体温が筒状体12内の骨セメント66に伝達することが抑制される。従って、骨セメント66が操作者の体温によって加温されることが抑制され、筒状体12内で骨セメント66の粘度の上昇速度を抑えることができる。 During the injection operation, the operator of the drug injection tool 10 holds the cylindrical body 12 with fingers, and the periphery of the cylindrical body 12 is covered with the cover member 16, and the cylindrical body 12, the cover member 16, Since the gap 48 formed between the two functions as a heat insulating layer, it is possible to suppress body temperature from being transmitted to the bone cement 66 in the tubular body 12 through the fingers of the operator during operation. Therefore, the bone cement 66 is suppressed from being heated by the body temperature of the operator, and the increase rate of the viscosity of the bone cement 66 in the cylindrical body 12 can be suppressed.
 上述した薬剤注入具10の使用方法では、X線透視下で骨セメント66を注入する際にX線の被曝を避けるために、延長チューブ80を用いたが、例えば、CT透視下で骨セメント66を注入する場合には、延長チューブ80を省略し、薬剤注入具10の筒状体12の先端管部20と骨セメント注入針72の注入ポート74とを直接連結してもよい。 In the above-described method of using the pharmaceutical injection tool 10, the extension tube 80 is used to avoid exposure to X-rays when injecting the bone cement 66 under fluoroscopy. For example, the bone cement 66 under CT fluoroscopy is used. May be omitted, and the distal end tube portion 20 of the cylindrical body 12 of the drug injector 10 and the injection port 74 of the bone cement injection needle 72 may be directly connected.
 以上説明したように、本実施形態に係る薬剤注入具10によれば、筒状体12の周囲がカバー部材16で覆われるので、操作時に操作者の手指を介して体温が筒状体12内の薬剤(骨セメント66)に伝達することが抑制される。このため、薬剤に熱が伝わることによる影響を低減することができる。 As described above, according to the pharmaceutical injection device 10 according to the present embodiment, since the periphery of the cylindrical body 12 is covered with the cover member 16, the body temperature is increased in the cylindrical body 12 through the fingers of the operator during operation. Transmission to the other drug (bone cement 66) is suppressed. For this reason, the influence by heat being transmitted to a chemical | medical agent can be reduced.
 また、カバー部材16は、筒状体12を立てるスタンドとしても機能するため、作業者が筒状体12を把持することなく、筒状体12の基端開口12bから薬剤を流し入れることができる。従って、薬剤の充填作業を簡便に行うことができる。 Further, since the cover member 16 also functions as a stand for standing the cylindrical body 12, the operator can pour the drug from the proximal end opening 12b of the cylindrical body 12 without gripping the cylindrical body 12. Therefore, the filling operation of the medicine can be performed easily.
 本実施形態の場合、カバー部材16と筒状体12との間に、筒状体12の周方向に沿う空隙48が形成される。従って、当該空隙48が断熱層として機能することにより、使用者から筒状体12内の薬剤への熱の伝達を一層効果的に低減することができる。 In the case of the present embodiment, a gap 48 is formed between the cover member 16 and the cylindrical body 12 along the circumferential direction of the cylindrical body 12. Therefore, when the gap 48 functions as a heat insulating layer, heat transfer from the user to the medicine in the cylindrical body 12 can be more effectively reduced.
 本実施形態の場合、カバー部材16は、筒状体12に対して軸線方向に変位可能であり、且つ、カバー部材16が筒状体12に対して最も基端側に変位した状態で、筒状体12の先端がカバー部材16の先端から突出する。この構成によれば、筒状体12に薬剤を充填した後に筒状体12の先端をカバー部材16から突出させることができるため、筒状体12に他の部材、例えば、骨セメント注入針72又は延長チューブ80を接続しやすい。 In the case of the present embodiment, the cover member 16 can be displaced in the axial direction with respect to the tubular body 12, and the cover member 16 is displaced in the most proximal direction with respect to the tubular body 12. The tip of the body 12 protrudes from the tip of the cover member 16. According to this configuration, since the tip of the cylindrical body 12 can be protruded from the cover member 16 after filling the cylindrical body 12 with the medicine, another member such as a bone cement injection needle 72 is provided on the cylindrical body 12. Or it is easy to connect the extension tube 80.
 本実施形態に係る薬剤注入具10は、筒状体12に対して着脱可能であり且つ押し子14が螺合状態で挿通されるガイド部材42を備え、さらに、ガイド部材42が筒状体12に対して連結された状態で、筒状体12とカバー部材16とが軸線方向に相対変位不可能に固定される。この構成によれば、カバー部材16を筒状体12に対して固定し一体化することにより、薬剤注入具10の使用時に、薬剤注入具10を安定して把持でき、操作性に優れる。また、ガイド部材42が、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16とを相互固定する機能をも備えるので、ガイド手段と連結手段とを個別の部品で構成する必要がなく、薬剤注入具10を簡素に構成できる。 The drug injection device 10 according to the present embodiment includes a guide member 42 that can be attached to and detached from the cylindrical body 12, and the pusher 14 is inserted in a screwed state, and the guide member 42 further includes the cylindrical body 12. The cylindrical body 12 and the cover member 16 are fixed so that they cannot be displaced relative to each other in the axial direction. According to this configuration, by fixing and integrating the cover member 16 with respect to the cylindrical body 12, the drug injection tool 10 can be stably held when using the drug injection tool 10, and the operability is excellent. In addition, the guide member 42 has not only a function of guiding the movement of the pusher 14 with respect to the cylindrical body 12 but also a function of mutually fixing the cylindrical body 12 and the cover member 16. It is not necessary to configure the medicine injection device 10 as individual parts, and the drug injection device 10 can be configured simply.
 本実施形態の場合、筒状体12の基端に設けられたフランジ部22が、カバー部材16とガイド部材42とにより軸線方向に挟まれるため、筒状体12とカバー部材16とを軸線方向の相対移動を阻止した状態でしっかりと固定することができる。 In the case of the present embodiment, since the flange portion 22 provided at the proximal end of the cylindrical body 12 is sandwiched between the cover member 16 and the guide member 42 in the axial direction, the cylindrical body 12 and the cover member 16 are axially disposed. It can be firmly fixed in a state in which relative movement is prevented.
 本実施形態に係る薬剤注入具10は、筒状体12とカバー部材16の周方向の相対回転を阻止する回転防止手段60(60a)を備えるため、カバー部材16を把持した状態(カバー部材16の回転が阻止された状態)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80又は骨セメント注入針72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。 Since the medicine injection device 10 according to the present embodiment includes the rotation preventing means 60 (60a) that prevents relative rotation of the cylindrical body 12 and the cover member 16 in the circumferential direction, the cover member 16 is gripped (the cover member 16). Even when the pusher 14 is rotated in a state where the rotation of the cylindrical body 12 is prevented, the cylindrical body 12 can be prevented from being rotated. For this reason, the extension tube 80 or the bone cement injection needle 72 connected to the tubular body 12 can be prevented from rotating with the rotation of the pusher 14, and the procedure is not hindered.
 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、本発明は前記実施の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. Needless to say.
 例えば、上述した実施形態では、筒状体12に対して押し子14を回転させることによって押し子14を前進させる「ネジ込み式」を採用したが、本発明はこれに限らず、筒状体12に対して押し子14が軸線方向に摺動自在であり、押し子14を回転させることなく、筒状体12に対して押し子14を先端方向に押圧することで、押し子14を前進させる「押し込み式」を採用してもよい。 For example, in the above-described embodiment, the “screw-in type” in which the pusher 14 is moved forward by rotating the pusher 14 with respect to the tubular body 12 is employed. However, the present invention is not limited to this, and the tubular body. The pusher 14 is slidable in the axial direction with respect to 12, and the pusher 14 is moved forward by pressing the pusher 14 against the cylindrical body 12 without rotating the pusher 14. A “push-in type” may be employed.
 上述した実施形態では、ガイド部材42とカバー部材16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16の基端に外方に突出する係合片が設けられ、ガイド部材42に当該係合片に嵌合可能な溝部が設けられ、カバー部材16とガイド部材42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。 In the above-described embodiment, the coupling structure between the guide member 42 and the cover member 16 is screw fitting. However, the coupling structure is not limited to this, and other coupling structures, for example, project outward to the base end of the cover member 16. An engagement piece is provided, and a groove portion that can be fitted to the engagement piece is provided in the guide member 42. By the relative rotation of the cover member 16 and the guide member 42, the engagement piece and the groove portion are engaged and disengaged. It is also possible to adopt a structure capable of
 上述した実施形態では、カバー部材16とガイド部材42とが結合することにより、ガイド部材42が筒状体12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42が直接、筒状体12に対して固定される構成を採用してもよい。この場合、例えば、筒状体12の基端外周部に雄ネジ部が設けられ、ガイド部材42に設けられた第2雌ネジ部54bと、当該雄ネジ部が螺合することにより、筒状体12に対してガイド部材42が固定される。 In the above-described embodiment, a configuration in which the guide member 42 is fixed to the cylindrical body 12 by coupling the cover member 16 and the guide member 42 is adopted. A configuration that is fixed to the cylindrical body 12 may be employed. In this case, for example, a male screw portion is provided on the outer peripheral portion of the base end of the cylindrical body 12, and the second female screw portion 54b provided on the guide member 42 and the male screw portion are screwed together to form a cylindrical shape. A guide member 42 is fixed to the body 12.

Claims (7)

  1.  内部に充填された薬剤を吐出する薬剤注入具(10)であって、
     先端に設けられた薬剤吐出口(12a)と、基端に設けられた開口部(12b)を有し、前記薬剤が充填される筒状体(12)と、
     前記筒状体(12)の中空部に液密に挿入され、前記筒状体(12)内を軸線方向に移動可能な押し子(14)と、
     前記薬剤注入具(10)の操作時に操作者の手指を介して体温が前記筒状体(12)内の前記薬剤に伝達することを抑制するために、前記筒状体(12)の周囲を覆うカバー部材(16)と、を備え、
     前記カバー部材(16)は、前記開口部(12b)を上方に向けた状態で前記筒状体(12)を支持することが可能なように構成される、
     ことを特徴とする薬剤注入具(10)。
    A drug injection device (10) for discharging a drug filled inside,
    A cylindrical body (12) having a medicine discharge port (12a) provided at the distal end and an opening (12b) provided at the proximal end and filled with the medicine;
    A pusher (14) that is liquid-tightly inserted into the hollow portion of the cylindrical body (12) and is movable in the axial direction within the cylindrical body (12);
    In order to prevent body temperature from being transmitted to the medicine in the tubular body (12) via the operator's fingers when operating the medicine infusion device (10), the periphery of the tubular body (12) is A cover member (16) for covering,
    The cover member (16) is configured to be able to support the cylindrical body (12) with the opening (12b) facing upward.
    A drug injection device (10) characterized by the above.
  2.  請求項1記載の薬剤注入具(10)において、
     前記カバー部材(16)と前記筒状体(12)との間に、前記筒状体(12)の周方向に沿う空隙(48)が形成される、
     ことを特徴とする薬剤注入具(10)。
    The drug injection device (10) according to claim 1, wherein
    A gap (48) is formed between the cover member (16) and the cylindrical body (12) along the circumferential direction of the cylindrical body (12).
    A drug injection device (10) characterized by the above.
  3.  請求項1記載の薬剤注入具(10)において、
     前記カバー部材(16)は、前記筒状体(12)の外周部に嵌合する嵌合部(44)と、前記嵌合部(44)の内径よりも大きい内径を有する拡径部(45)とを有し、
     前記カバー部材(16)に前記筒状体(12)が挿通された状態で、前記カバー部材(16)の前記拡径部(45)の内周面と前記筒状体(12)の外周面との間に、軸線方向に延在する環状の空隙(48)が形成される、
     ことを特徴とする薬剤注入具(10)。
    The drug injection device (10) according to claim 1, wherein
    The cover member (16) includes a fitting portion (44) fitted to the outer peripheral portion of the cylindrical body (12), and an enlarged diameter portion (45) having an inner diameter larger than the inner diameter of the fitting portion (44). )
    In a state where the cylindrical body (12) is inserted through the cover member (16), an inner peripheral surface of the enlarged diameter portion (45) of the cover member (16) and an outer peripheral surface of the cylindrical body (12). An annular gap (48) extending in the axial direction is formed between
    A drug injection device (10) characterized by the above.
  4.  請求項1記載の薬剤注入具(10)において、
     前記カバー部材(16)は、前記筒状体(12)に対して軸線方向に変位可能であり、
     前記カバー部材(16)が前記筒状体(12)に対して最も基端側に変位した状態で、前記筒状体(12)の先端が前記カバー部材(16)の先端から突出する、
     ことを特徴とする薬剤注入具(10)。
    The drug injection device (10) according to claim 1, wherein
    The cover member (16) is displaceable in the axial direction with respect to the cylindrical body (12),
    In a state where the cover member (16) is displaced to the most proximal side with respect to the tubular body (12), the distal end of the tubular body (12) protrudes from the distal end of the cover member (16).
    A drug injection device (10) characterized by the above.
  5.  請求項1記載の薬剤注入具(10)において、
     前記カバー部材(16)に対して着脱可能であり、且つ前記押し子(14)が螺合状態で挿通されるガイド部材(42)を備え、
     前記ガイド部材(42)が前記カバー部材(16)に対して連結された状態で、前記筒状体(12)と前記カバー部材(16)とが軸線方向に相対変位不可能に固定される、
     ことを特徴とする薬剤注入具(10)。
    The drug injection device (10) according to claim 1, wherein
    A guide member (42) that can be attached to and detached from the cover member (16) and into which the pusher (14) is inserted in a screwed state;
    In a state where the guide member (42) is connected to the cover member (16), the cylindrical body (12) and the cover member (16) are fixed so as not to be relatively displaceable in the axial direction.
    A drug injection device (10) characterized by the above.
  6.  請求項5記載の薬剤注入具(10)において、
     前記筒状体(12)の基端にフランジ部(22)が設けられ、
     前記フランジ部(22)が、前記カバー部材(16)と前記ガイド部材(42)とにより軸線方向に挟まれる、
     ことを特徴とする薬剤注入具(10)。
    The drug injection device (10) according to claim 5,
    A flange portion (22) is provided at the proximal end of the cylindrical body (12),
    The flange portion (22) is sandwiched in the axial direction by the cover member (16) and the guide member (42).
    A drug injection device (10) characterized by the above.
  7.  請求項5記載の薬剤注入具(10)において、
     前記筒状体(12)と前記カバー部材(16)の周方向の相対回転を阻止する回転防止手段(60、60a)を備える、
     ことを特徴とする薬剤注入具(10)。
    The drug injection device (10) according to claim 5,
    Rotation prevention means (60, 60a) for preventing circumferential rotation of the cylindrical body (12) and the cover member (16);
    A drug injection device (10) characterized by the above.
PCT/JP2013/057589 2012-03-22 2013-03-18 Drug injection device WO2013141187A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012-065259 2012-03-22
JP2012065259 2012-03-22

Publications (1)

Publication Number Publication Date
WO2013141187A1 true WO2013141187A1 (en) 2013-09-26

Family

ID=49222644

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2013/057589 WO2013141187A1 (en) 2012-03-22 2013-03-18 Drug injection device

Country Status (1)

Country Link
WO (1) WO2013141187A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017029716A1 (en) * 2015-08-19 2017-02-23 佐藤製薬株式会社 Syringe for tympanic injection
JP2018011957A (en) * 2016-07-21 2018-01-25 ヘレウス メディカル ゲーエムベーハー Bone cement applicator including three-way valve for pressure relief

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007216009A (en) * 2006-01-30 2007-08-30 Howmedica Internatl S De Rl Syringe and stand
JP2008541945A (en) * 2005-05-31 2008-11-27 マリンクロッド・インコーポレイテッド Syringe heat retainer and method of using the same
JP4257976B2 (en) * 2001-08-20 2009-04-30 シンセス ゲーエムベーハー Threaded syringe for delivery of bone substitute material
WO2010128855A2 (en) * 2009-05-04 2010-11-11 Mahayana Holding B.V. Container for a liquid material to be supplied to a body, which container can be heated by an exothermic reaction
JP2011213415A (en) * 2010-03-18 2011-10-27 Tokuyama Dental Corp Knock type discharging vessel
US8096975B2 (en) * 2007-05-29 2012-01-17 Lewis Van L Injector and thermal jacket for use with same

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4257976B2 (en) * 2001-08-20 2009-04-30 シンセス ゲーエムベーハー Threaded syringe for delivery of bone substitute material
JP2008541945A (en) * 2005-05-31 2008-11-27 マリンクロッド・インコーポレイテッド Syringe heat retainer and method of using the same
JP2007216009A (en) * 2006-01-30 2007-08-30 Howmedica Internatl S De Rl Syringe and stand
US8096975B2 (en) * 2007-05-29 2012-01-17 Lewis Van L Injector and thermal jacket for use with same
WO2010128855A2 (en) * 2009-05-04 2010-11-11 Mahayana Holding B.V. Container for a liquid material to be supplied to a body, which container can be heated by an exothermic reaction
JP2011213415A (en) * 2010-03-18 2011-10-27 Tokuyama Dental Corp Knock type discharging vessel

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017029716A1 (en) * 2015-08-19 2017-02-23 佐藤製薬株式会社 Syringe for tympanic injection
JP6113935B1 (en) * 2015-08-19 2017-04-12 佐藤製薬株式会社 Syringe syringe
EP3338837A4 (en) * 2015-08-19 2018-08-22 Sato Pharmaceutical Co., Ltd. Syringe for tympanic injection
JP2018011957A (en) * 2016-07-21 2018-01-25 ヘレウス メディカル ゲーエムベーハー Bone cement applicator including three-way valve for pressure relief

Similar Documents

Publication Publication Date Title
RU2718291C2 (en) Syringe with collapsible membrane
US6916308B2 (en) High pressure injection syringe
CA2413665C (en) Multi-use surgical cement dispenser apparatus and kit for same
US8608707B2 (en) Autoinjector with rotatable deshielder for axially displacing a needle shield
US20120330229A1 (en) Syringe-like mixing device having a distally operable mixing element
JP5385074B2 (en) Drug infusion tool
NO132921B (en)
US20200164324A1 (en) A storage, mixing and dispensing device
KR20140037035A (en) Hydraulic injection system for bone cement
US20180001033A1 (en) An Injection Needle Assembly for an Injection Device and an Injection Device Comprising Such Assembly
US10994071B2 (en) Syringe adapter with concentric rings
WO2012066905A1 (en) Drug injection device
JP6023185B2 (en) Drug infusion tool
WO2013141187A1 (en) Drug injection device
JP6981976B2 (en) Syringe
JP2015066070A (en) Drug injector
US9408975B2 (en) Apparatus for operating syringe piston
WO2013141188A1 (en) Drug injection device
US10420892B2 (en) Drive mechanism for a medicament delivery device
JP2014057780A (en) Medicine injection instrument
US11679002B2 (en) Bone graft material loading assembly and associated devices, systems, and methods
US9314288B2 (en) Dispensing device for bone cement
IT202100027785A1 (en) SYRINGE WITH SPRING

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 13764931

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 13764931

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: JP