WO2018168989A1 - Dispositif d'administration de médicament liquide - Google Patents

Dispositif d'administration de médicament liquide Download PDF

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Publication number
WO2018168989A1
WO2018168989A1 PCT/JP2018/010170 JP2018010170W WO2018168989A1 WO 2018168989 A1 WO2018168989 A1 WO 2018168989A1 JP 2018010170 W JP2018010170 W JP 2018010170W WO 2018168989 A1 WO2018168989 A1 WO 2018168989A1
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WO
WIPO (PCT)
Prior art keywords
tip
distal end
tube
connector
needle
Prior art date
Application number
PCT/JP2018/010170
Other languages
English (en)
Japanese (ja)
Inventor
有延学
沖原等
飯渕るり子
桝田多恵子
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2019506254A priority Critical patent/JP6975772B2/ja
Publication of WO2018168989A1 publication Critical patent/WO2018168989A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/12—Tube connectors; Tube couplings for joining a flexible tube to a rigid attachment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic

Definitions

  • the present invention relates to a chemical solution administration system including a chemical solution administration device having a chemical solution container filled with a chemical solution, and an administration device having a connector connectable to the chemical solution container.
  • a syringe pump type chemical solution administration device that administers a chemical solution filled in a chemical solution container into a living body under the action of a pusher is known.
  • This type of chemical solution administration device includes a barrel-type chemical solution container and a pusher mechanism that pushes out the chemical solution in the chemical solution container.
  • a tube with a needle is connected to the drug solution administration device as an administration device for transferring the drug solution from the drug solution administration device into the patient's body.
  • connection structure between a chemical solution administration device and a tube with a needle there is known a structure in which a connector provided at an end portion of a tube with a needle is connected to a distal end portion of a chemical solution container by screwing (for example, Japanese Patent No. 4759630). See the official gazette).
  • a sealing member rubber plug
  • the needle provided on the connector is sealed when the connector and the chemical solution container are connected. It penetrates the member.
  • the connector and the chemical container are connected by turning and screwing the connector. For this reason, when a needle pierces the sealing member, there is a possibility that coring that scrapes off the sealing member may occur.
  • the present invention has been made in consideration of such problems, and an object thereof is to provide a chemical solution administration system capable of suppressing the occurrence of coring when the connector and the chemical solution container are connected.
  • the present invention has a chemical solution container that can be filled with a chemical solution, a chemical solution administration device that includes a housing that contains the chemical solution container, and a connector that can be connected to the chemical solution container, An administration device for delivering a chemical solution to a patient, wherein the chemical solution container includes a barrel part that can be filled with the chemical solution therein, a protruding part from the trunk part in a distal direction, and a distal end A barrel having a tip opening provided on the tip opening, a sealing member made of an elastic material for liquid-tightly sealing the tip opening, and fixing the sealing member to the tip barrel A housing main body for holding the chemical solution container, and a guide that protrudes from the housing main body and surrounds the outer peripheral surface of the tip tube portion, and is disposed substantially concentrically with the tip tube portion.
  • the connector includes a needle tube having a needle point through which the sealing member can be pierced, and a connector body that holds the needle tube, and the connector body has the needle tube so that the needle point is a free end. And a guide receiving tube portion that protrudes from the base portion so as to surround the outer peripheral surface of the needle tube and is disposed substantially concentrically with the needle tube, and protrudes along the needle tube from the base portion and the needle tube. And an engaging portion that is engageable with the tip tube portion, and when the connector is connected to the chemical solution container, the needle tip is the sealing member.
  • the inner peripheral surface of the guide tube portion can contact the outer peripheral surface of the guide tube portion, and when the connector is connected to the drug solution container, the engaging portion is Inserted between the tube portion and the guide tube portion, and Characterized in that it is configured to engage the serial distal tube portion.
  • the engagement portion is engaged with the fixed member by the relative movement of the connector relative to the distal end tubular portion in the axial direction.
  • the main body of the connector is guided by the guide cylinder provided in the housing. Therefore, the needle is punctured into the sealing member without rotating with respect to the sealing member and without tilting. For this reason, it is possible to effectively suppress the occurrence of coring in which the needle scrapes off the sealing member when connecting the connector and the distal end cylindrical portion.
  • the fixing member has an engaging protrusion that engages with the engaging portion on an outer peripheral surface of the fixing member, and the engaging portion is engaged with the tip tube portion via the engaging protrusion of the fixing member. May be possible.
  • This configuration makes it possible to more stably guide the connector by the guide tube portion when the connector and the tip tube portion are connected.
  • the guide tube portion may have a grip portion for gripping the connector on the outer peripheral surface of the guide tube portion when the connector is connected to the chemical solution container.
  • the engaging portion between the engaging portion and the fixing member can be covered with the outer cylindrical portion, so that the engagement between the engaging portion and the fixing member can be reliably maintained.
  • a plurality of the engaging portions are arranged at intervals in the circumferential direction, and are provided at an engaging arm that is elastically deformable in the radial direction, and at a free end portion of each engaging arm, and protrudes inward in the radial direction. You may have a claw part.
  • the engagement portion can be engaged with the fixing member with an appropriate force, and an engagement structure that cannot be easily detached can be obtained.
  • the engagement portion may include a support tube portion protruding from the base portion, and the engagement arm may extend in a proximal direction from a base end of the support tube portion.
  • This configuration ensures that the engagement arm is elastically deformed when engaged, and the engaged state is reliably maintained after engagement.
  • the engaging arm and the claw portion may be formed in an arc shape along a circumference centering on the needle tube.
  • This configuration can effectively increase the engaging force between the engaging portion and the fixing member.
  • the engaging portion When the connector is connected to the chemical solution container, the engaging portion may be configured to slide on the outer peripheral surface of the fixing member.
  • the engaging portion When connecting the connector to the chemical solution container, the engaging portion may be configured to contact the outer peripheral surface of the fixing member before the needle tip starts to pierce the sealing member.
  • the housing body has an abutting outer peripheral surface adjacent to the proximal end of the guide tube portion, and in a state where the connection between the connector and the chemical solution container is completed, the protruding end portion of the guide receiving tube portion of the connector body is The housing may be configured to contact the contact outer peripheral surface.
  • This configuration suppresses the occurrence of rattling at the connection between the connector and the housing during use of the drug solution administration device after connection between the connector and the tip tube. For this reason, it is possible to prevent the user from feeling uneasy and to prevent a decrease in liquid tightness.
  • the distal end cylinder part has an outer diameter smaller than the outer diameter of the body part
  • the chemical solution container has a shoulder part that connects the body part and the distal end cylinder part
  • the fixing member A clamping portion that clamps the sealing member between the distal end surface of the distal end cylindrical portion and a peripheral wall portion extending in the proximal direction from the clamping portion, and the proximal end surface of the peripheral wall portion of the fixing member is You may adjoin or contact
  • This configuration prevents the fixing member from rattling with respect to the tip tube portion, so that the adhesion between the sealing member and the tip tube portion can be maintained. For this reason, liquid-tightness can be maintained satisfactorily and chemical liquid leakage can be prevented.
  • the distal end cylinder part has a rattling-preventing convex part that protrudes radially outward from the outer peripheral surface of the distal end cylinder part, and the inner peripheral surface of the peripheral wall part of the fixing member is the same as that of the distal end cylinder part. You may adjoin or contact
  • This configuration prevents the fixing member from rattling with respect to the tip tube portion, so that the adhesion between the sealing member and the tip tube portion can be maintained. For this reason, liquid-tightness can be maintained satisfactorily and chemical liquid leakage can be prevented.
  • the connector body includes a needle hub member having the base for holding the needle tube, a guide member having the guide receiving tube portion and the engagement portion, and joined to the needle hub member.
  • a positioning convex portion is provided on one of the proximal end surface of the hub member and the distal end surface of the guide member, and a positioning concave portion in which the positioning convex portion is fitted is provided on the other of the needle hub member and the guide member. It may be provided.
  • the fixing member includes a clamping portion that clamps the sealing member between a distal end surface of the distal end cylindrical portion, and an outer peripheral portion of the sealing member includes the distal end surface of the distal end cylindrical portion and the fixing member. It may be pinched
  • the fixing member includes a holding portion that holds the sealing member between a front end surface of the front end cylindrical portion, and a peripheral wall portion that extends in a proximal direction from the holding portion, and the peripheral wall portion of the fixing member
  • a locking protrusion for preventing the sealing member from falling off from the fixing member may be provided on the inner peripheral surface of the fixing member before the fixing member is attached to the distal end tubular portion.
  • the sealing member can be held in the fixing member when the fixing member is attached to the distal end tube portion in the assembly process. For this reason, the assembly
  • tip cylinder part can be performed easily.
  • the fixing member includes a sandwiching portion that sandwiches the sealing member with a distal end surface of the distal end cylindrical portion, and a distal end hole portion that penetrates a central portion of the sandwiching portion in the axial direction, and the sealing member
  • the member may have a tip protrusion that is inserted into the tip hole of the fixing member and protrudes in the tip direction from the tip of the fixing member.
  • This configuration makes it easy to wipe the surface of the sealing member protruding from the fixing member with alcohol cotton or the like before connecting the connector.
  • the sealing member may have a proximal end convex portion that is inserted into the distal end cylindrical portion and compressed radially inward by the inner peripheral surface of the distal end cylindrical portion.
  • This configuration can further improve the liquid tightness of the sealing member.
  • the fixing member includes a sandwiching portion that sandwiches the sealing member with a distal end surface of the distal end cylindrical portion, and a distal end hole portion that penetrates a central portion of the sandwiching portion in the axial direction, and the sealing member
  • the member has a distal end convex portion inserted into the distal end hole portion of the fixing member and a proximal end convex portion inserted into the distal end cylindrical portion, and the distal end convex portion is in a natural state before elastic deformation.
  • the base end convex part may have a symmetrical shape in the axial direction.
  • the present invention is a connector connectable to a chemical solution administration device having a chemical solution container that can be filled with a chemical solution and a housing that accommodates the chemical solution container, and the distal end of the distal end cylinder portion provided in the chemical solution container
  • a needle tube having a needle tip that can be pierced with a sealing member that seals the opening; and a connector main body that holds the needle tube, and the connector main body includes the needle tube such that the needle tip is a free end.
  • a guide receiving tube portion that protrudes from the base portion so as to surround the outer peripheral surface of the needle tube and is disposed substantially concentrically with the needle tube, and protrudes along the needle tube from the base portion and the needle tube.
  • An inner peripheral surface of the guide receiving tube portion is configured to contact an outer peripheral surface of a guide tube portion provided in the housing, and when the connector is connected to the drug solution container, It is configured to be inserted between the tip tube portion of the chemical solution container and the guide tube portion of the housing and to be engaged with the tip tube portion of the drug solution container.
  • the present invention is a chemical container that can be filled with a chemical solution, and can be connected to a connector provided in an administration device for feeding the chemical solution to a patient, and a trunk portion that can be filled with the chemical solution inside
  • a barrel having a tip tube portion protruding in the tip direction from the body portion and provided with a tip opening at the tip, and a sealing member made of an elastic material that seals the tip opening in a liquid-tight manner
  • a fixing member that fixes the sealing member to the distal end cylindrical portion, and the fixing member sandwiches the sealing member between the distal end surface of the distal end cylindrical portion and the center of the clamping portion.
  • the sealing member has a tip convex portion that is inserted into the tip hole portion of the fixing member and protrudes in the tip direction from the tip of the fixing member. It is characterized by.
  • the present invention is a sealing member made of an elastic material that liquid-tightly seals the tip opening of a chemical solution container that can be filled with a chemical solution
  • the chemical solution container includes a barrel portion that can be filled with the chemical solution therein. And sandwiching the sealing member between a barrel having a tip tube portion protruding from the body portion in the tip direction and provided with the tip opening at the tip, and a tip surface of the tip tube portion
  • a fixing member having a tip hole portion penetrating in the axial direction through a central portion of the clamping portion, a tip convex portion inserted into the tip hole portion of the fixing member, and the tip cylinder And having a base end convex portion inserted into the portion, and in a natural state before elastic deformation, the tip convex portion and the base end convex portion are symmetrical in the axial direction.
  • the present invention also provides a chemical solution administration device having a chemical solution container that can be filled with a chemical solution and a housing that accommodates the chemical solution container, to which a connector of an administration device for delivering the chemical solution to a patient can be connected.
  • the chemical solution container includes a barrel having a barrel portion that can be filled with the chemical solution, a distal end cylindrical portion that protrudes from the barrel portion in a distal direction and is provided with a distal end opening at the distal end, and the distal end
  • a sealing member made of an elastic material that seals the opening in a liquid-tight manner, and a fixing member that fixes the sealing member to the distal end tube portion
  • the housing includes a housing body that holds the chemical solution container;
  • the outer peripheral surface of the front end cylindrical portion is protruded from the housing main body and has a protective cylindrical portion arranged substantially concentrically with the front end cylindrical portion, and the fixing member is provided on the outer peripheral surface of the fixing member.
  • Engagement provided in the connector And has an engaging engagement
  • the present invention includes a chemical solution administration device having a chemical solution container that can be filled with a chemical solution, a housing that houses the chemical solution container, and a connector that can be connected to the chemical solution container, and the chemical solution is sent to a patient.
  • a method for connecting to an administration device comprising: a barrel portion that can be filled with the drug solution; and a distal end cylindrical portion that projects from the barrel portion in the distal direction and is provided with a distal end opening.
  • the chemical solution container including a barrel, a sealing member made of an elastic material that seals the tip opening in a liquid-tight manner, and a fixing member that fixes the sealing member to the tip tube portion, and holds the chemical solution container And a housing that protrudes from the housing body and surrounds an outer peripheral surface of the tip tube portion and has a guide tube portion that is disposed substantially concentrically with the tip tube portion. Stop member can be pierced A needle tube having a needle tip; and a connector main body for holding the needle tube, wherein the connector main body has a base portion for holding the needle tube so that the needle tip is a free end, and an outer peripheral surface of the needle tube from the base portion.
  • the connector having an engaging portion engageable with the distal end cylindrical portion is prepared, and the connector is directed toward the housing in a state where the needle tip of the connector is opposed to the sealing member of the chemical solution container.
  • the guide tube portion of the housing is inserted into the guide tube portion of the connector body, and the needle tip is sealed after the guide tube portion is inserted into the guide tube portion.
  • the engaging portion of the connector main body is inserted between the tip tube portion and the guide tube portion and penetrates the sealing member with the needle tube, and then the engagement portion and the tip tube are inserted. It is characterized by engaging the part.
  • FIG. 5A is an external perspective view of the fixing member
  • FIG. 5B is a cross-sectional perspective view of the fixing member
  • 6A is an external perspective view of the needle hub member and the needle tube
  • FIG. 6B is a cross-sectional perspective view of the needle hub member and the needle tube.
  • FIG. 7A is an external perspective view of a guide member
  • FIG. 7B is an external perspective view of the guide member from another angle.
  • the drug solution administration system 10 includes a drug body 12 (barrel) that forms a drug solution container that can be filled with a drug solution M, a drug solution administration device 12 that includes a housing 18 that houses the tube body 16, and a connector that can be connected to the cylinder body 16. 30 and an administration device 14 having 30.
  • the drug solution M is filled in the cylinder 16 in advance in the product provision state.
  • the medicinal solution administration device 12 continuously administers the medicinal solution M filled in the cylinder 16 into the living body over a relatively long time (for example, several minutes to several hours) under the pressing action of the pusher mechanism. .
  • the chemical solution administration device 12 may intermittently administer the chemical solution M into the living body.
  • the drug solution M include protein preparations, narcotic analgesics, diuretics and the like.
  • a patch-type needle-attached tube 15 is connected to the drug solution administration device 12 as the administration device 14, and the drug solution M discharged from the cylindrical body 16 has a needle. It is injected into the patient's body through the tube 15.
  • the drug solution administration device 12 further includes a gasket slidably disposed in the cylinder body 16, a pusher mechanism connected to the gasket, a drive unit that drives the pusher mechanism, and a drug solution.
  • a battery that supplies power necessary for the operation of the administration device 12 and a control unit that controls the drive unit are provided.
  • the pusher mechanism, the drive unit, the battery, and the control unit are accommodated in the housing 18.
  • the cylindrical body 16 is formed in a hollow cylindrical shape having a chemical solution chamber 16a therein.
  • the cylindrical body 16 includes a body portion 16b having a constant inner diameter and outer diameter in the axial direction, and a shoulder portion 16c whose inner diameter and outer diameter are tapered from the distal end of the body portion 16b toward the distal end. And a tip tube portion 16d protruding in the tip direction from the shoulder portion 16c.
  • a proximal end opening 16e is formed at the proximal end of the barrel portion 16b.
  • a distal end opening portion 16f communicating with the chemical solution chamber 16a is formed in the distal end cylindrical portion 16d.
  • the chemical solution M is filled in the cylindrical body 16 in advance.
  • a backlash prevention convex portion 16g for preventing backlash of the fixing member 26 described later is provided on the outer periphery of the base end portion of the distal end cylindrical portion 16d.
  • the rattling prevention convex portion 16g is formed in an annular shape that bulges outward in the radial direction and extends one round in the circumferential direction.
  • the base end of the rattling prevention convex part 16g is continued to the front end of the shoulder part 16c.
  • the fixing member 26 is located on the tip side (between the tip surface of the tip cylindrical portion 16d and the rattling prevention convex portion 16g) with respect to the rattle preventing convex portion 16g.
  • An engagement convex portion 16h that engages with the engagement claw 26a is provided.
  • the engaging convex portion 16h is formed in an annular shape protruding outward in the radial direction and extending once in the circumferential direction.
  • the engaging convex portion 16h has a locking surface 16h1 to which the engaging claw 26a is locked, and an inclined surface 16h2 that is formed on the distal end side with respect to the locking surface 16h1 and is reduced in diameter toward the distal direction.
  • the housing 18 includes a housing main body 20 that holds the cylindrical body 16, and a guide cylindrical portion 22 that protrudes from the housing main body 20, surrounds the outer peripheral surface of the distal end cylindrical portion 16d, and is disposed substantially concentrically with the distal end cylindrical portion 16d.
  • a guide tube portion 22 is integrally formed with the housing body 20.
  • the guide tube portion 22 may be a member manufactured as a separate component from the housing body 20 and fixed to the housing body 20.
  • the guide tube portion 22 is formed in a hollow cylindrical shape and is arranged concentrically with the tip tube portion 16d.
  • the outer peripheral surface 22a of the guide cylinder part 22 is a taper shape in which an outer diameter reduces toward a front-end
  • the outer peripheral surface 22a of the guide tube portion 22 may have a straight shape with an outer diameter constant in the axial direction.
  • the distal end surface 22b of the guide cylinder portion 22 is located on the distal end side with respect to the distal end surface of the distal end cylinder portion 16d.
  • the housing 18 has a top surface 18a and a bottom surface 18b.
  • the drug solution administration device 12 may be configured as a patch type that is used by being attached to the skin of a patient, for example.
  • the bottom surface 18b of the housing 18 is provided with a sheet-like sticking part (adhesive part) that can be stuck to the skin.
  • a peelable protective sheet is stuck on the sticking surface of the sticking part.
  • the medicinal solution administration device 12 may be configured as a type in which an attachment such as a hook or a clip is provided on the bottom surface 18b of the housing 18 and attached to a patient's clothes (for example, a waist portion of trousers). . Further, the cylindrical body 16 filled with the chemical M, the gasket slidably disposed in the cylindrical body 16, and the pusher mechanism are combined in advance and may be inserted into the housing 18 at the time of use. . In this case, it is preferable that a mounting portion for mounting the pusher mechanism on the cylinder body 16 is provided in the pusher mechanism and the cylinder body 16.
  • the medicinal solution administration device 12 further includes a sealing member 24 made of an elastic material that seals the distal end opening 16 f of the cylindrical body 16 in a liquid-tight manner, and a distal end opening of the cylindrical body 16.
  • a fixing member 26 that fixes the sealing member 24 to the distal end cylindrical portion 16d provided with 16f is provided.
  • the sealing member 24 is made of an elastic resin material such as a rubber material or an elastomer material, and is a plug that seals the tip opening 16f in a liquid-tight manner by being in close contact with the tip surface 16de of the tip tube portion 16d.
  • the sealing member 24 includes a sealing base portion 24a that forms a central portion in the thickness direction, a tip convex portion 24b that protrudes in the tip direction from the tip surface of the sealing base portion 24a, And a base end convex portion 24c protruding in the base end direction from the base end surface of the sealing base portion 24a.
  • the cross-sectional shapes perpendicular to the axial direction of the sealing base 24a, the tip convex portion 24b, and the base end convex portion 24c are all circular.
  • the outer diameters of the tip convex part 24b and the base end convex part 24c are smaller than the outer diameter of the sealing base part 24a.
  • the tip protrusion 24 b protrudes in the tip direction from the tip of the fixing member 26.
  • the outer peripheral portion of the sealing member 24 (the outer peripheral portion of the sealing base portion 24a) is sandwiched between the distal end surface of the distal end cylindrical portion 16d and the inner end surface of the fixing member 26 (the proximal end surface of a clamping portion 26d described later). It is compressed in the axial direction. For this reason, the front end surface 24a1 of the outer peripheral part of the sealing base 24a is in liquid-tight contact with the base end surface of the clamping part 26d.
  • the proximal end surface 24a2 of the outer peripheral portion of the sealing base portion 24a is in liquid-tight contact with the distal end surface of the distal end cylindrical portion 16d.
  • the tip convex portion 24b and the base end convex portion 24c are symmetrical in the axial direction. That is, the tip convex part 24b and the base end convex part 24c have the same outer diameter and the protruding height from the sealing base part 24a.
  • the outer diameter of the base end convex portion 24c is larger than the inner diameter of the distal end cylindrical portion 16d in a natural state before elastic deformation, but in FIG. 2, the proximal end convex portion 24c is elastically deformed and enters the inside of the distal end cylindrical portion 16d. It is out (fitted). For this reason, the base end convex portion 24c is in liquid-tight contact with the inner peripheral surface of the distal end cylindrical portion 16d.
  • the base end convex portion 24c may have a shape that does not liquid-tightly adhere to the inner peripheral surface of the distal end cylindrical portion 16d.
  • the outer diameter of the base end convex portion 24c is smaller than the inner diameter of the distal end cylindrical portion 16d.
  • the outer diameter of the distal convex portion 24b is smaller than the inner diameter of the distal cylindrical portion 16d, like the proximal convex portion 24c.
  • the fixing member 26 is a hollow cylindrical member attached to the distal end cylinder part 16d so as to cover the distal end cylinder part 16d, and holds the sealing member 24 between the distal end cylinder part 16d.
  • an engagement claw 26 a protruding inward in the radial direction is provided on the inner peripheral surface of the fixing member 26.
  • a plurality of engagement claws 26a are provided at intervals in the circumferential direction.
  • a claw forming hole portion 26c is provided at a position adjacent to the distal end side of the engagement claw 26a.
  • a pinching portion 26d protruding inward in the radial direction is provided at the distal end portion of the fixing member 26.
  • a tip hole portion 26d1 that penetrates the central portion of the sandwiching portion 26d in the axial direction is formed by the inner peripheral surface of the sandwiching portion 26d.
  • an annular locking projection 26e bulging inward in the radial direction is provided on the inner peripheral surface of the fixing member 26.
  • the locking protrusion 26e is a protrusion for preventing the sealing member 24 from falling off the fixing member 26 before the fixing member 26 is attached to the distal end cylindrical portion 16d.
  • the locking projection 26e is formed between the clamping portion 26d and the engagement claw 26a.
  • An engaging protrusion 26f is provided on the outer peripheral portion of the fixing member 26 so that an engaging portion 54 (described later) of the connector 30 can be engaged therewith.
  • the engagement protrusion 26f is formed in an annular shape that protrudes outward in the radial direction and extends around the circumference in the circumferential direction.
  • the engagement protrusion 26f is provided on the proximal end side with respect to the engagement claw 26a.
  • the engaging protrusion 26f may be provided on the distal end cylindrical portion 16d.
  • the base end face 26 g of the fixing member 26 is close to or in contact with the cylindrical body 16. Specifically, the base end face 26g of the fixing member 26 is close to or in contact with the front end face of the shoulder portion 16c.
  • the proximal end inner peripheral surface 26h of the fixing member 26 is close to or abuts on the outer peripheral surface of the distal end cylindrical portion 16d. Specifically, the inner peripheral surface 26h of the base end portion of the fixing member 26 is close to or in contact with the outer peripheral surface of the backlash prevention convex portion 16g.
  • the tube 15 with a needle includes a connector 30 that can be connected to the distal end cylindrical portion 16 d of the cylindrical body 16, a flexible liquid feeding tube 32 having one end connected to the connector 30, and the other end of the liquid feeding tube 32.
  • a patch portion (not shown) that is connected and can be attached to the patient's skin, and an injection needle (not shown) protruding from the patch portion are provided. The injection needle is punctured into the patient's skin.
  • the administration device 14 connected to the drug solution administration device 12 is not limited to the above-described patch-type tube 15 with a needle.
  • a puncture needle (such as a winged needle) is connected to the tip of the liquid delivery tube 32. May be.
  • the administration device 14 may be a bent needle that can be connected to the distal end cylindrical portion 16d of the cylindrical body 16 without using the liquid feeding tube 32.
  • the bent needle is bent approximately 90 ° downward from the distal end cylindrical portion 16d of the cylindrical body 16, and punctures perpendicularly to the skin as the drug solution administration device 12 is fixed (attached) to the skin. Is done.
  • the connector 30 includes a connector main body 34 that can be fitted into the guide tube portion 22, and a needle tube 36 that is held by the connector main body 34 and can be pierced with the sealing member 24.
  • the connector main body 34 has a needle hub member 38 having a base portion 38a for holding the needle tube 36 so that the needle tip 36b becomes a free end, and protrudes from the base portion 38a so as to surround the outer peripheral surface of the needle tube 36 and is substantially concentric with the needle tube 36.
  • a guide member 40 having a guide receiving cylinder part 40a (protective cylinder part) arranged in a conventional manner.
  • the base portion 38a protrudes from the outer peripheral surface of the needle connection portion 42, the needle connection portion 42 to which the needle tube 36 is connected, the tube connection portion 44 that is provided coaxially with the needle connection portion 42 and to which the liquid feeding tube 32 is connected.
  • the flange portion 46 is provided.
  • the needle connecting portion 42 is formed with a linear needle holding hole 42a for holding the needle tube 36.
  • a rough surface region 42b having a concavo-convex shape (wave shape) is provided. Since the rough surface region 42b is provided, the bonding strength can be improved when the needle tube 36 is bonded to the needle connecting portion 42 with an adhesive.
  • a tapered concave portion 42c whose inner diameter increases toward the proximal end direction is provided.
  • the tapered recess 42c functions as an adhesive reservoir, so that the joining strength can be improved.
  • the tube connecting portion 44 is formed with a linear tube holding hole 44a for holding the liquid feeding tube 32.
  • the tube holding hole 44a has a straight portion 44a1 having a constant inner diameter in the axial direction and a tapered portion 44a2 having an inner diameter increasing in the distal direction. Since the tapered portion 44a2 is provided, it is easy to insert the liquid feeding tube 32 when the liquid feeding tube 32 is inserted into the tube holding hole 44a in the assembly process. Further, when the liquid feeding tube 32 is bonded to the tube connecting portion 44 with an adhesive, the taper portion 44a2 functions as an adhesive reservoir, so that the bonding strength can be improved.
  • the flange portion 46 is formed in an annular shape that protrudes outward in the radial direction from the outer peripheral surface of the needle connection portion 42 and makes one round in the circumferential direction.
  • the flange part 46 is joined to the guide receiving cylinder part 40a by an appropriate joining means (for example, adhesive, ultrasonic welding, etc.).
  • the needle connecting portion 42 described above protrudes in the axial direction from the distal end surface 46 a and the proximal end surface 46 b of the flange portion 46.
  • a positioning convex portion 48 protruding in the proximal direction is provided on the proximal end surface 46 b of the flange portion 46.
  • the positioning convex portion 48 is disposed on a circumference centered on the central axis of the base portion 38a.
  • a plurality of positioning convex portions 48 are provided at intervals in the circumferential direction. For this reason, when the flange part 46 is joined to the guide receiving cylinder part 40a with an adhesive, the adhesive enters between the positioning convex parts 48 adjacent in the circumferential direction, so that the joining strength can be improved.
  • the positioning convex portion 48 may be formed in an annular shape that makes a round in the circumferential direction. When the positioning convex portion 48 is joined to the guide receiving tube portion 40a by ultrasonic welding, the positioning convex portion 48 is preferably formed in an annular shape that makes one round in the circumferential direction.
  • the guide tube portion 40a is a hollow cylindrical member surrounding the needle tube 36 protruding from the base portion 38a, and is joined to the base end surface 46b of the flange portion 46 of the base portion 38a.
  • the guide receiving tube portion 40a includes a cylindrical outer tube portion 50 that can be fitted to the outer peripheral surface of the guide tube portion 22, an annular tip wall 52 joined to the flange portion 46 of the base portion 38a, It has an engaging portion 54 that protrudes from the base portion 38 a along the needle tube 36 and is provided inside the outer tube portion 50 (between the needle tube 36 and the outer tube portion 50) and engageable with the fixing member 26.
  • the inner peripheral surface 50a of the outer cylinder part 50 is formed in a taper shape whose inner diameter increases in the proximal direction.
  • the inner peripheral surface 50a of the outer cylinder part 50 may be formed in a straight shape having a constant inner diameter in the axial direction.
  • a connector side rattle prevention portion 50b is provided at the base end of the outer cylinder portion 50.
  • the connector-side rattle prevention portion 50b is formed in an annular shape that bulges outward in the radial direction and makes one round in the circumferential direction.
  • the distal end wall 52 is a plate-like portion that is continuous with the distal end of the outer cylindrical portion 50 and is perpendicular to the axis of the base portion 38a. As shown in FIG. 7B, an annular positioning recess 56 that is recessed in the proximal direction is provided on the distal end surface of the distal end wall 52. The positioning recess 56 is disposed on a circumference centered on the central axis of the base 38a. A positioning convex portion 48 is fitted into the positioning concave portion 56 and is joined by an appropriate joining means (for example, adhesive, ultrasonic fusion, etc.).
  • an appropriate joining means for example, adhesive, ultrasonic fusion, etc.
  • the positioning concave portion 56 may be provided in the flange portion 46 of the base portion 38a, and the positioning convex portion 48 may be provided in the distal end wall 52 of the guide receiving tube portion 40a.
  • the engaging portion 54 is configured to be able to engage with the fixing member 26 along with the relative displacement in the axial direction with respect to the distal end cylindrical portion 16d when the connector 30 is connected to the distal end cylindrical portion 16d.
  • the engaging portion 54 is configured to be inserted between the distal end cylindrical portion 16d and the guide cylindrical portion 22 and to be engaged with the distal end cylindrical portion 16d.
  • the engaging portion 54 can be engaged with the distal end tubular portion 16 d via the engaging protrusion 26 f of the fixing member 26.
  • the engaging part 54 has a support cylinder part 58 protruding from the base part 38a.
  • the engaging portion 54 is supported by a support cylinder 58 that extends in the proximal direction from the inner end of the distal end wall 52, and extends from the proximal end of the support cylinder 58 in the proximal direction.
  • the engaging portion 54 includes a plurality of engaging arms 54a arranged at intervals in the circumferential direction, and claws provided at the free ends of the engaging arms 54a and projecting inward in the radial direction.
  • the engagement arm 54 a extends from the proximal end of the support cylinder portion 58 in the proximal direction.
  • the engaging arm 54a is configured as an elastic piece that can be elastically deformed in the radial direction.
  • the claw portion 54 b can be engaged with the engagement protrusion 26 f of the fixing member 26.
  • the engaging arm 54a and the claw portion 54b are formed in an arc shape along a circumference centering on the central axis (the needle tube 36) of the base portion 38a.
  • the claw portion 54b is disposed on the distal end side of the proximal end surface of the outer cylinder portion 50 (the proximal end surface of the connector-side rattling prevention portion 50b).
  • the needle tube 36 is a hollow needle tube configured in a straight line and having a lumen 36 a, and the lumen 36 a communicates with the lumen of the liquid feeding tube 32.
  • the needle tube 36 has a portion protruding in the proximal direction from the base portion 38a (needle connection portion 42), and has a sharp needle tip 36b at the end portion on the protruding side.
  • the needle tip 36b may be provided with a bent shape that bends toward the needle center axis.
  • the administration device 14 is not connected to the drug solution administration device 12 in the initial state before use. Therefore, when using the drug solution administration system 10, the administration device 14 is connected to the drug solution administration device 12. Specifically, the connector 30 is connected to the distal end tubular portion 16 d of the tubular body 16.
  • the chemical solution administration device 12 is attached to the patient by attaching it to the patient's skin or attaching it to clothes.
  • an injection needle (not shown) of the administration device 14 is punctured into the patient's skin.
  • the drug solution administration device 12 may be attached to the patient before the puncture of the injection needle into the skin.
  • the chemical liquid administration device 12 receives a predetermined operation start command
  • the gasket is pressed by the pusher mechanism, and the chemical liquid M in the cylindrical body 16 is pushed out by advancing the gasket in the cylindrical body 16.
  • the drug solution M pushed out from the cylindrical body 16 is administered (injected) into the patient's body through the administration device 14 punctured by the patient.
  • connection between the connector 30 and the distal end cylindrical portion 16d of the cylindrical body 16 is performed as follows.
  • the connector 30 is moved toward the housing 18 with the needle tip 36b facing the sealing member 24 of the cylindrical body 16, so that the guide cylindrical portion 22 of the housing 18 is inserted into the guide receiving cylindrical portion 40a of the connector main body 34. Insert. Specifically, as shown in FIG. 8, the connector main body 34 is opposed to the distal end cylindrical portion 16 d and the guide cylindrical portion 22, and the needle tip 36 b is opposed to the sealing member 24 of the cylindrical body 16. By moving 34 to the housing body 20 side, the connection between the connector 30 and the distal end cylindrical portion 16d is started. In this case, since the guide tube portion 22 of the housing 18 and the outer tube portion 50 of the connector 30 serve as a fitting guide, the connector 30 can move straight along the axial direction of the tip tube portion 16d. That is, the inner peripheral surface 50 a of the outer cylindrical portion 50 is slidably supported by the outer peripheral surface 22 a of the guide cylindrical portion 22.
  • the needle tube 36 is punctured into the sealing member 24.
  • the needle tube 36 vertically penetrates the sealing member 24, and the lumen of the needle tube 36 communicates with the drug solution chamber 16 a in the cylindrical body 16.
  • the claw portion 54b of the engaging portion 54 is pushed by the engaging protrusion 26f of the fixing member 26, and the engaging arm 54a bends outward (elasticity). Deform).
  • the drug solution administration system 10 has the following effects.
  • the engagement portion 54 engages with the fixing member 26 by the relative movement of the connector 30 relative to the distal end cylindrical portion 16 d in the axial direction.
  • the connector main body 34 is guided by the guide tube portion 22 provided in the housing 18. Therefore, the needle tube 36 is punctured into the sealing member 24 without rotating with respect to the sealing member 24 and without tilting. For this reason, it is possible to effectively suppress the occurrence of coring in which the needle tube 36 scrapes the sealing member 24 when the connector 30 and the distal end cylinder portion 16d are connected.
  • the connector main body 34 has an outer cylindrical portion 50 surrounding the needle tube 36, and the inner peripheral surface 50 a of the outer cylindrical portion 50 can be fitted to the outer peripheral surface 22 a of the guide cylindrical portion 22. With this configuration, the connector 30 can be more stably guided by the guide tube portion 22 when the connector 30 and the distal end tube portion 16d are connected.
  • the engaging portion 54 is provided inside the outer cylindrical portion 50. With this configuration, the engaging portion between the engaging portion 54 and the fixing member 26 can be covered with the outer cylindrical portion 50, so that the engagement between the engaging portion 54 and the fixing member 26 can be reliably maintained. Become.
  • the engaging portion 54 has a plurality of claw portions 54b arranged in the circumferential direction. With this configuration, the engaging portion 54 can be engaged with the fixing member 26 with an appropriate force, and an engaging structure that cannot be easily detached can be constructed.
  • the engaging portion 54 includes a plurality of engaging arms 54a that are arranged at intervals in the circumferential direction and can be elastically deformed in the radial direction, and a claw portion 54b provided at a free end of each engaging arm 54a.
  • the engaging arm 54a and the claw portion 54b are formed in an arc shape along the circumference centering on the needle tube 36 (FIG. 7A). With this configuration, the engagement force between the engagement portion 54 and the fixing member 26 can be effectively increased.
  • the engaging portion 54 When connecting the connector 30 to the cylindrical body 16, the engaging portion 54 is configured to slide on the outer peripheral surface of the fixing member 26 (FIG. 9). With this configuration, the needle tube 36 is further prevented from being tilted with respect to the sealing member 24 when the connector 30 and the distal end cylindrical portion 16d are connected, so that the occurrence of coring can be more effectively suppressed. .
  • the engaging portion 54 When connecting the connector 30 to the cylindrical body 16, the engaging portion 54 is configured to contact the outer peripheral surface of the fixing member 26 before the needle tip 36 b starts to pierce the sealing member 24 (FIG. 9). .
  • the sealing member 24 is not punctured while the needle tube 36 is tilted, the occurrence of coring can be more effectively suppressed.
  • the housing body 20 has an abutting outer peripheral surface 20a adjacent to the proximal end of the guide tube portion 22, and the protruding end of the guide receiving tube portion 40a of the connector body 34 when the connector 30 and the distal end tube portion 16d are completely connected.
  • the part is configured to contact the housing 18 (FIG. 11).
  • the distal end cylinder part 16d has an outer diameter smaller than the outer diameter of the body part 16b, the cylinder body 16 has a shoulder part 16c that connects the body part 16b and the front end cylinder part 16d, and the fixing member 26 is It has a clamping part 26d for clamping the sealing member 24 between the distal end surface of the distal end cylinder part 16d and a peripheral wall part 26b extending in the proximal direction from the clamping part 26d.
  • the proximal end surface of the peripheral wall portion 26b of the fixing member 26 is close to or in contact with the distal end surface of the shoulder portion 16c (FIG. 2).
  • the front end cylinder part 16d has a backlash prevention convex part 16g that protrudes radially outward from the outer peripheral surface of the front end cylinder part 16d.
  • the base end face 26g of the fixing member 26 is in close proximity to or in contact with the rattle-preventing convex part 16g of the distal end cylindrical part 16d.
  • a positioning convex portion 48 is provided on one of the distal end surfaces of the needle hub member 38 and the guide member 40, and the positioning convex portion 48 is fitted on the other of the distal end surfaces of the needle hub member 38 and the guide member 40.
  • a positioning recess 56 is provided.
  • the outer peripheral portion (sealing base portion 24a) of the sealing member 24 is sandwiched between the distal end surface 16de of the distal end cylindrical portion 16d and the inner end portion of the fixing member 26 (the proximal end surface of the clamping portion 26d) and compressed in the axial direction. Has been. With this configuration, high adhesion of the sealing member 24 can be obtained, so that the desired pressure resistance of the cylindrical body 16 can be easily ensured.
  • the inner peripheral surface of the peripheral wall portion 26b of the fixing member 26 is provided with a locking projection 26e for preventing the sealing member 24 from falling off the fixing member 26 before the fixing member 26 is attached to the distal end cylindrical portion 16d. (FIG. 5B).
  • the sealing member 24 has a tip convex portion 24 b that is inserted into the tip hole portion 26 d 1 of the fixing member 26 and protrudes in the tip direction from the tip of the fixing member 26.
  • the sealing member 24 has a proximal end convex portion 24c that is inserted into the distal end cylindrical portion 16d and compressed radially inward by the inner peripheral surface of the distal end cylindrical portion 16d, the liquid-tightness of the sealing member 24 Can be further improved. Since the base end convex portion 24c is compressed radially inward and a liquid-tight seal is formed between the base end convex portion 24c and the inner peripheral surface of the distal end cylindrical portion 16d, the distal end opening portion 16f is securely inserted. It can be sealed.
  • the sealing member 24 has a distal end convex portion 24b inserted into the distal end hole portion 26d1 and a proximal end convex portion 24c inserted into the distal end cylindrical portion 16d, and the distal end convex portion is in a natural state before elastic deformation.
  • the part 24b and the base end convex part 24c are symmetrical in the axial direction.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un système d'administration de médicament liquide (10) qui est pourvu d'un dispositif d'administration de médicament liquide (12) et d'un instrument d'administration (14). Le dispositif d'administration de médicament liquide (12) est pourvu d'un boîtier (18) accueillant un cylindre (16) et comprenant une partie de cylindre de guidage (22), un élément d'étanchéité (24) et un élément de fixation (26) pour fixer l'élément d'étanchéité (24). Un raccord (30) de l'instrument d'administration (14) comprend un corps de raccord (34) pouvant s'ajuster à la partie de cylindre de guidage (22). Le corps de raccord (34) comprend une partie de cylindre de réception de guidage (40a) disposée de façon sensiblement concentrique par rapport à un tube d'aiguille (36) et une partie de couplage (54) pouvant se coupler à l'élément de fixation (26) lors de son déplacement par rapport à une partie de cylindre d'extrémité distale (16d) dans une direction axiale.
PCT/JP2018/010170 2017-03-16 2018-03-15 Dispositif d'administration de médicament liquide WO2018168989A1 (fr)

Priority Applications (1)

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JP2019506254A JP6975772B2 (ja) 2017-03-16 2018-03-15 薬液投与システム

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JP2017-051395 2017-03-16
JP2017051395 2017-03-16

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WO2018168989A1 true WO2018168989A1 (fr) 2018-09-20

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019182031A1 (fr) * 2018-03-20 2019-09-26 テルモ株式会社 Capuchon et ensemble seringue et son procédé de fabrication
JPWO2020195363A1 (fr) * 2019-03-26 2020-10-01

Citations (4)

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Publication number Priority date Publication date Assignee Title
JPS5023194U (fr) * 1973-06-27 1975-03-15
US4416661A (en) * 1981-12-24 1983-11-22 Cutter Laboratories, Inc. Injection site for fluids
WO2016014365A1 (fr) * 2014-07-21 2016-01-28 Medtronic Minimed, Inc. Interface de connexion intelligente
US20160361491A1 (en) * 2015-06-11 2016-12-15 Steadymed Ltd. Infusion set

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US441661A (en) * 1890-12-02 Time-measuring device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5023194U (fr) * 1973-06-27 1975-03-15
US4416661A (en) * 1981-12-24 1983-11-22 Cutter Laboratories, Inc. Injection site for fluids
WO2016014365A1 (fr) * 2014-07-21 2016-01-28 Medtronic Minimed, Inc. Interface de connexion intelligente
US20160361491A1 (en) * 2015-06-11 2016-12-15 Steadymed Ltd. Infusion set

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019182031A1 (fr) * 2018-03-20 2019-09-26 テルモ株式会社 Capuchon et ensemble seringue et son procédé de fabrication
JPWO2019182031A1 (ja) * 2018-03-20 2021-03-11 テルモ株式会社 キャップ、シリンジ組立体及びその製造方法
JP7201663B2 (ja) 2018-03-20 2023-01-10 テルモ株式会社 キャップ、シリンジ組立体及びその製造方法
US11938305B2 (en) 2018-03-20 2024-03-26 Terumo Kabushiki Kaisha Cap, syringe assembly and manufacturing method thereof
JPWO2020195363A1 (fr) * 2019-03-26 2020-10-01
WO2020195363A1 (fr) * 2019-03-26 2020-10-01 テルモ株式会社 Structure de raccordement et outil d'administration de médicaments liquides
EP3922289A4 (fr) * 2019-03-26 2022-04-06 TERUMO Kabushiki Kaisha Structure de raccordement et outil d'administration de médicaments liquides
JP7413355B2 (ja) 2019-03-26 2024-01-15 テルモ株式会社 接続構造及び薬液投与器具

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JP6975772B2 (ja) 2021-12-01
JPWO2018168989A1 (ja) 2020-01-16

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