WO2016152377A1 - Ensemble cathéter - Google Patents

Ensemble cathéter Download PDF

Info

Publication number
WO2016152377A1
WO2016152377A1 PCT/JP2016/055806 JP2016055806W WO2016152377A1 WO 2016152377 A1 WO2016152377 A1 WO 2016152377A1 JP 2016055806 W JP2016055806 W JP 2016055806W WO 2016152377 A1 WO2016152377 A1 WO 2016152377A1
Authority
WO
WIPO (PCT)
Prior art keywords
hub
needle
guide wire
catheter
catheter assembly
Prior art date
Application number
PCT/JP2016/055806
Other languages
English (en)
Japanese (ja)
Inventor
横田崇之
石田昌弘
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 WO2016152377A1 publication Critical patent/WO2016152377A1/fr

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06Body-piercing guide needles or the like

Definitions

  • the present invention relates to a catheter assembly that punctures and indwells a blood vessel when, for example, infusion is performed on a patient.
  • a catheter assembly when an infusion or the like is performed on a patient, for example, a catheter assembly is used.
  • This type of catheter assembly includes a hollow catheter, a catheter hub fixed to the proximal end of the outer needle, a hollow inner needle that is inserted into the catheter and has a sharp needle tip, and a base of the inner needle.
  • a needle hub fixed to the end.
  • the inner needle in order to facilitate insertion of the catheter into the blood vessel, the inner needle is inserted into the lumen of the inner needle so as to be slidable in the axial direction. Some have a guide wire that can protrude from the tip.
  • the catheter assembly of JP 2013-529111 A includes a safety member that covers the tip of the inner needle when the inner needle is removed from the catheter.
  • the distal end of the guide wire protrudes from the distal end of the inner needle when the inner needle is removed from the catheter. For this reason, even when the tip of the inner needle is protected by the safety member, the blood adhering to the guide wire may be scattered because the tip of the guide wire protrudes from the safety member.
  • the present invention has been made in view of such problems, and an object thereof is to provide a catheter assembly that can prevent blood adhering to a guide wire from scattering.
  • a catheter assembly includes a catheter, a catheter hub fixed to a proximal end portion of the catheter, and a hollow that is removably inserted into the catheter.
  • An inner needle, a needle hub fixed to the proximal end portion of the inner needle, a guide wire that is slidably inserted into the inner needle, is longer than the catheter, and has a distal end that can protrude from the needle tip,
  • a guide wire hub that supports the guide wire and is movable relative to the needle hub in the axial direction within a restricted range, and moves the guide wire relative to the inner needle as it moves.
  • the needle hub or the inner needle is provided with a first engagement portion
  • the guide wire hub or the guide wire is provided with a second engagement portion that can be engaged with the first engagement portion.
  • the catheter assembly of the present invention configured as described above, when the guide wire hub is moved backward relative to the catheter having the distal end portion inserted into the blood vessel, the distal end portion of the guide wire is more proximal than the needle tip.
  • the needle hub moves backward together with the guide wire hub by engaging the first engaging portion and the second engaging portion after retracting to the end side. Then, as the needle hub moves backward, the inner needle is removed from the catheter.
  • the distal end portion of the guide wire is accommodated in the inner needle. Therefore, according to the present invention, it is possible to prevent blood adhering to the guide wire from being scattered.
  • the guide wire hub may have a housing portion that covers a part of the outer peripheral surface of the needle hub.
  • This configuration makes it easy for the user to grip the guide wire hub and to shorten the overall length of the catheter assembly in the initial state.
  • the housing portion may cover the outer peripheral surface of the needle hub at at least two opposing positions.
  • one of the guide wire hub and the needle hub has an engagement portion moving space in which the first engagement portion or the second engagement portion can move, and the first engagement portion
  • the distance that the second engaging portion can move from one end to the other end of the engaging portion moving space may be longer than the distance that the tip of the guide wire can protrude from the needle tip.
  • the first engagement portion may be provided on the outer peripheral surface of the needle hub, and the second engagement portion may be provided on the housing portion of the guide wire hub.
  • first engagement portion and the second engagement portion can be provided with a simple configuration.
  • the first engagement portion has a form of a first protrusion protruding from the outer peripheral surface of the needle hub, and the second engagement portion is formed by the first engagement portion. May also have a form of a second protrusion protruding in the circumferential direction on the tip side.
  • the proximal end position of the movable range in the axial direction of the guide wire hub with respect to the needle hub is reliably defined under the engagement action of the first protrusion and the second protrusion, and the guide wire hub is defined as the catheter hub. Therefore, it is possible to reliably construct a mechanism for moving the needle hub together when moving in the proximal direction.
  • the first engagement portion has a form of an engagement hole or an engagement groove provided in the outer peripheral surface of the needle hub, and the second engagement portion is the housing portion. You may have the form of the engagement protrusion which protruded inward from the inner peripheral surface.
  • the proximal end position of the movable range in the axial direction with respect to the needle hub of the guide wire hub is reliably defined under the engagement action between the engagement hole or the engagement groove and the engagement protrusion, and the guide wire hub It is possible to reliably construct a mechanism that moves the needle hub together when the needle hub is moved in the proximal direction with respect to the catheter hub.
  • the needle hub has a body portion inserted into the guide wire hub, and a flange portion provided at a proximal end portion of the body portion, and the flange portion is the first portion.
  • An engagement portion may be configured, and a proximal end portion of the guide wire hub may configure the second engagement portion.
  • the most proximal end position of the movable range in the axial direction with respect to the needle hub of the guide wire hub is reliably defined under the engaging action of the flange portion and the proximal end portion of the guide wire hub. It is possible to reliably construct a mechanism that moves the needle hub together when moving in the proximal direction with respect to the catheter hub.
  • the catheter assembly further includes a protector that covers at least the needle tip of the inner needle as the inner needle is removed from the catheter, and the needle hub holds the inner needle inside the protector.
  • a cover housing chamber may be formed between the inner shell portion and the outer shell portion.
  • the cover housing chamber may be formed between the inner shell portion and the outer shell portion.
  • This configuration can shorten the overall length of the catheter assembly in the initial state.
  • the guide wire hub has a wire holding portion that holds the guide wire, and the wire holding portion moves the guide wire hub relative to the needle hub in the distal direction.
  • the needle hub may enter the inside of the inner shell.
  • This configuration can further shorten the overall length of the catheter assembly in the initial state.
  • the catheter assembly may further include a protector that covers at least the needle tip of the inner needle as the inner needle is removed from the catheter.
  • the protector since the protector covers the needle tip of the inner needle as the inner needle is removed from the catheter, it is possible to more effectively prevent the blood adhering to the guide wire from being scattered.
  • the catheter assembly of the present invention includes a catheter, a catheter hub fixed to the proximal end of the catheter, a hollow inner needle that has a needle tip and is removably inserted into the catheter, A needle hub fixed to the proximal end of the needle, a guide wire that is slidably inserted into the inner needle, is longer than the inner needle and the catheter, and has a distal end protruding from the needle tip; and the guide wire A guide wire hub fixed to the proximal end portion of the needle wire and movable relative to the needle hub in the axial direction within a restricted range with respect to the needle hub, wherein the guide wire hub has the needle hub at least at two opposite positions.
  • the needle hub is provided with a first engaging portion, and the guide wire hub is engageable with the first engaging portion.
  • a first engaging portion is provided.
  • the catheter assembly of the present invention includes a catheter, a catheter hub fixed to the proximal end of the catheter, a hollow inner needle that has a needle tip and is removably inserted into the catheter, A needle hub fixed to the proximal end portion of the needle, a guide wire that is slidably inserted into the inner needle and has a distal end protruding from the needle tip, and is fixed to the proximal end portion of the guide wire; A guide wire hub that is relatively movable in the axial direction within a restricted range with respect to the hub, and the guide wire hub and the needle hub have a tip of the guide wire protruding from the needle tip.
  • the guide wire hub engages with the needle hub after the distal end of the guide wire is accommodated in the inner needle.
  • the catheter assembly of the present invention it is possible to prevent blood adhering to the guide wire from scattering.
  • FIG. 2 is a perspective view of a needle hub and guide wire hub of the catheter assembly shown in FIG. 1.
  • 3A is a first diagram illustrating a method of using the catheter assembly shown in FIG. 1
  • FIG. 4B is a fourth diagram for explaining a method of using the catheter assembly shown in FIG.
  • FIG. 6 is a perspective view of the needle hub and guide wire hub of the catheter assembly shown in FIG. 5.
  • FIG. 5 is a perspective view of the needle hub and guide wire hub of the catheter assembly shown in FIG. 5.
  • FIG. 7A is a first diagram for explaining how to use the catheter assembly shown in FIG. 5, and FIG. 7B is a second diagram for explaining how to use the catheter assembly shown in FIG.
  • FIG. 8A is a third diagram for explaining how to use the catheter assembly shown in FIG. 5, and FIG. 8B is a fourth diagram for explaining how to use the catheter assembly shown in FIG. It is a typical sectional view of the catheter assembly concerning a 3rd embodiment of the present invention.
  • 10A is a perspective view of the needle hub and guide wire hub of the catheter assembly shown in FIG. 9, and FIG. 10B is an exploded perspective view of the needle hub and guide wire hub of the catheter assembly shown in FIG.
  • FIG. 11A is a first diagram for explaining how to use the catheter assembly shown in FIG. 9, and FIG. 11B is a second diagram for explaining how to use the catheter assembly shown in FIG.
  • FIG. 12A is a third diagram for explaining how to use the catheter assembly shown in FIG. 9, and FIG. 12B is a fourth diagram for explaining how to use the catheter
  • the catheter assembly 10A according to the first embodiment shown in FIGS. 1 to 3B is used, for example, to administer an infusion solution (medical solution) to a patient.
  • the catheter assembly 10A can be configured as a catheter that is longer than the peripheral venous catheter (eg, central venous catheter, PICC, midline catheter, etc.).
  • the catheter assembly 10A may be configured as a peripheral venous catheter.
  • the catheter assembly 10A is not limited to a venous catheter, and may be configured as an arterial catheter such as a peripheral artery catheter.
  • the catheter assembly 10A includes a catheter 12, a catheter hub 14 fixed to the catheter 12, a hollow inner needle 16 inserted into the catheter 12, a needle hub 18 fixed to the inner needle 16, and a needle hub 18.
  • An inserted guide wire 20, a guide wire hub 22 that supports the guide wire 20, and a protector 24 connected to the needle hub 18 and the catheter hub 14 are provided.
  • the catheter 12 is a flexible thin tubular member formed in a predetermined length.
  • a lumen 13 is formed in the catheter 12 so as to extend in the axial direction and penetrate therethrough.
  • the diameter of the lumen 13 is set to a size that allows the inner needle 16 to be inserted.
  • a resin material in particular, a soft resin material is suitable.
  • fluorine resins such as polytetrafluoroethylene (PTFE), ethylene / tetrafluoroethylene copolymer (ETFE), perfluoroalkoxy fluorine resin (PFA), olefin resins such as polyethylene and polypropylene, or a mixture thereof.
  • PTFE polytetrafluoroethylene
  • ETFE ethylene / tetrafluoroethylene copolymer
  • PFA perfluoroalkoxy fluorine resin
  • olefin resins such as polyethylene and polypropylene, or a mixture thereof.
  • Polyurethane polyester, polyamide, polyether nylon resin, a mixture of the olefin resin and an ethylene / vinyl acetate copolymer, and the like.
  • the catheter 12 may be made of a resin having transparency so that all or part of the inside can be visually recognized.
  • the catheter 12 may have an imaging function including an X-ray (radiation) opaque material (for example, barium oxide or the like).
  • the length of the catheter 12 is not particularly limited, and is appropriately set according to the use and various conditions.
  • the length of the catheter 12 is set to, for example, about 20 to 500 mm, or set to about 30 to 400 mm, or set to about 100 to 300 mm.
  • the catheter hub 14 is connected and fixed to the proximal end of the catheter 12 in a liquid-tight manner.
  • a catheter member 15 is constituted by the catheter 12 and the catheter hub 14.
  • a hard resin is suitable as the constituent material of the catheter hub 14.
  • the hard resin that can be applied to the catheter hub 14 include various resin materials such as thermoplastic resins such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer.
  • thermoplastic resins such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer.
  • the distal end portion of the catheter hub 14 may be made soft.
  • the soft resin applicable to the distal end portion of the catheter hub 14 include polyurethane, polypropylene, polyethylene, silicone rubber, isoprene rubber, polyvinyl chloride, 1,2-polybutadiene, styrene-ethylene / butylene-styrene block copolymer. And various resin materials.
  • the inner needle 16 has a distal end opening 16a and a proximal end opening, and a lumen extending between the distal end opening 16a and the proximal end opening.
  • the inner needle 16 is formed linearly.
  • a sharp needle tip 16 b is formed at the tip of the inner needle 16.
  • the length of the inner needle 16 is longer than the length of the catheter 12.
  • the inner needle 16 may be provided with a groove along the axial direction.
  • the inner needle 16 is inserted into the lumen 13 of the catheter 12, and the distal end of the inner needle 16 protrudes from the distal end opening of the catheter 12 by a predetermined length.
  • the proximal end of the inner needle 16 protrudes more proximally than the proximal end portion of the catheter member 15 (the proximal end portion of the catheter hub 14).
  • the inner needle 16 has rigidity capable of puncturing the patient's skin. Although it does not specifically limit as a constituent material of the inner needle 16, For example, stainless steel, aluminum or an aluminum alloy, metal materials like titanium or a titanium alloy, hard resin, ceramics, etc. are mentioned.
  • the needle hub 18 is an operation unit that is gripped by a user when performing a puncturing operation for puncturing the living body with the tips of the inner needle 16 and the catheter 12.
  • the needle hub 18 includes a needle holding portion 26 that holds the inner needle 16 inside the protector 24, an inner shell portion 28 that extends in the proximal direction from the needle holding portion 26, and an inner shell so as to cover the inner shell portion 28. It has the outer shell part 30 extended in the axial direction along the part 28, and the connection part 32 which connects the inner shell part 28 and the base ends of the outer shell part 30.
  • the proximal end portion of the inner needle 16 is fixed to the distal end portion of the needle holding portion 26.
  • the needle holding part 26 has an insertion hole 26a penetrating in the axial direction.
  • the guide wire 20 is inserted through the insertion hole 26a.
  • the diameter of the insertion hole 26a is larger than the outer diameter of the guide wire 20, and the guide wire 20 can be displaced in the axial direction within the insertion hole 26a.
  • each of the inner shell portion 28 and the outer shell portion 30 is formed in a hollow cylindrical shape extending in the circumferential direction and the axial direction. Therefore, the inner shell portion 28 and the outer shell portion 30 are arranged concentrically.
  • the connecting part 32 is formed in a ring shape. Note that each of the inner shell portion 28 and the outer shell portion 30 may be formed in a hollow cylindrical shape having an elliptical or polygonal cross-sectional shape.
  • a cover housing chamber 34 is formed between the inner shell portion 28 (and the needle holding portion 26) and the outer shell portion 30.
  • the cover housing chamber 34 opens in the distal direction.
  • the base end of the cover housing chamber 34 is closed by the connecting portion 32.
  • the cover housing chamber 34 formed between them has an annular shape. In the initial state of the catheter assembly 10 ⁇ / b> A, the protector 24 is accommodated in the cover accommodation chamber 34.
  • a protruding portion 36 that protrudes outward in the radial direction from the other portion of the outer shell 30 is provided on the outer peripheral portion of the outer shell 30.
  • the outer shell portion 30 is provided with a first protrusion 40 that protrudes radially outward from the outer peripheral surface of the outer shell portion 30 as the first engaging portion 38.
  • two first protrusions 40 are provided that protrude in the circumferential direction opposite to each other from the base end portion of the raised portion 36.
  • a finger holding portion 42 is provided for applying a finger when the user operates the needle hub 18.
  • the finger holding portion 42 in the illustrated example is slightly recessed from other portions on the outer surface of the raised portion 36.
  • the finger holder 42 is provided with a large number of small protrusions that function as slip stoppers when operated by touching with a finger.
  • a guide wire 20 guides the catheter 12 when the catheter 12 is inserted into a blood vessel in order to place the catheter 12 in a patient.
  • the guide wire 20 is a thin linear member having flexibility and is longer than the inner needle 16 and the catheter 12.
  • the outer diameter of the guide wire 20 is smaller than the diameter of the lumen of the inner needle 16.
  • the guide wire 20 is slidably inserted into the lumen of the inner needle 16, and in the initial state of the catheter assembly 10A, the distal end portion of the guide wire 20 is closer to the proximal end than the needle tip 16b of the inner needle 16. In the illustrated example, it is located in the vicinity of the needle tip 16b.
  • the distal end portion of the guide wire 20 protrudes from the needle tip 16b by a predetermined length.
  • the proximal end portion of the guide wire 20 is located on the proximal end side with respect to the proximal end portion of the catheter hub 14.
  • the constituent material of the guide wire 20 is not particularly limited.
  • various metal materials such as stainless steel and Ni—Ti alloy can be used.
  • the guide wire hub 22 is an operation unit for performing an operation of inserting the guide wire 20 into the blood vessel prior to the operation of inserting the catheter 12 into the blood vessel of the patient.
  • the guide wire hub 22 supports the guide wire 20 and is relatively movable in the axial direction within a range restricted with respect to the needle hub 18, and moves the guide wire 20 relative to the inner needle 16 as it moves. It is configured as follows.
  • the guide wire hub 22 is fixed to the proximal end portion of the guide wire 20.
  • the guide wire hub 22 has a wire holding portion 44 that fixes and holds the proximal end portion of the guide wire 20, and a hollow cylindrical shape that protrudes outward from the wire holding portion 44 and extends in the distal direction. Housing portion 46.
  • the wire holding portion 44 is formed in a size that allows entry into the inner shell portion 28 of the needle hub 18.
  • the distal end of the wire holding portion 44 is located on the proximal side of the needle hub 18 (the wire holding portion 44 has entered the inner shell portion 28). Absent).
  • the tip of the wire holding portion 44 may enter the inner shell portion 28.
  • the housing part 46 is formed in a hollow cylindrical shape.
  • the housing portion 46 protrudes radially outward from the wire holding portion 44 and extends from the radially outer end of the proximal wall 48 in the distal direction to cover a part of the outer peripheral surface of the needle hub 18.
  • a peripheral wall 50 is provided.
  • the proximal end portion of the needle hub 18 is located on the distal end side with respect to the region 52 between the outer peripheral surface of the wire holding portion 44 and the inner peripheral surface of the peripheral wall portion 50 (the region). 52, the proximal end of the needle hub 18 does not enter).
  • a notch portion 54 that extends in the axial direction, penetrates in the thickness direction of the peripheral wall portion 50, and opens in the distal end direction is formed in the distal end side region of the peripheral wall portion 50.
  • a second protrusion 58 that protrudes in the circumferential direction toward the raised portion 36 provided on the needle hub 18 is provided as a second engagement portion 56 at the distal end opening of the notch 54.
  • the two 2nd projection parts 58 are provided in the direction which mutually opposes.
  • the second engaging portion 56 (second projecting portion 58) can be engaged with the first engaging portion 38 (first projecting portion 40) described above. Specifically, the second engagement portion 56 engages with the first engagement portion 38 when the guide wire hub 22 is retracted to a predetermined position with respect to the needle hub 18. When the second engagement portion 56 is engaged with the first engagement portion 38, the relative movement of the guide wire hub 22 in the proximal direction with respect to the needle hub 18 is prevented.
  • the guide wire hub 22 has an engaging portion moving space in which the first engaging portion 38 can move, and the distance that the first engaging portion 38 can move from one end to the other end of the engaging portion moving space is the guide wire.
  • the tip of 20 is longer than the distance that can protrude from the needle tip 16b.
  • the engaging portion moving space refers to the space from the base end of the first engaging portion 38 to the base end of the notch portion 54 as the axial direction, and the radial direction space of the notch portion 54 as the radial direction. Point to.
  • One end of the engaging portion moving space is located at the proximal end of the first engaging portion 38, and the other end of the engaging portion moving space is located at the proximal end of the notch portion 54.
  • the distance that the first engaging portion 38 can move from one end to the other end of the engaging portion moving space is longer than the distance that the tip of the guide wire 20 can protrude from the needle tip 16b. 16 can be reliably pulled in.
  • a finger holding portion 60 is provided for applying a finger when the user operates the guide wire hub 22.
  • the finger holder 60 in the illustrated example is slightly recessed from other portions on the outer surface of the peripheral wall 50.
  • the finger holder 60 is provided with a large number of small protrusions that function as slip stoppers when operated by touching with a finger.
  • the protector 24 covers at least the needle tip 16 b of the inner needle 16 as the inner needle 16 is removed from the catheter 12.
  • the protector 24 includes a hollow first cover cylinder 62 that is detachably connected to the catheter hub 14, and the first cover cylinder 62 is inserted on the inner side, and the protector 24 is axial with respect to the first cover cylinder 62.
  • a hollow second cover cylinder 64 that can be slid.
  • the second cover cylinder 64 is a relay cylinder that connects the first cover cylinder 62 and the needle hub 18.
  • connection structure in which the first cover cylinder 62 is detachably connected to the catheter hub 14 can take various forms such as engagement (hook) and fitting.
  • connection structure provided at the distal end portion of the first cover cylinder 62 has one or more engagement arms 66 as indicated by phantom lines in FIG.
  • the engagement arm 66 is provided at the distal end portion of the first cover cylinder 62 and is releasably engaged with the proximal end outer peripheral portion of the catheter hub 14.
  • the first cover cylinder 62 includes an inner cylinder in which the engagement arm 66 is provided, an inner cylinder disposed on the inner side, and a shaft that is restricted with respect to the inner cylinder. And an outer cylinder slidable in the direction.
  • the engagement arm 66 is accommodated at the distal end portion of the outer cylinder while being engaged with the catheter hub 14, and is prevented from opening.
  • the inner cylinder is provided with a stopper that prevents the inner cylinder from moving relative to the outer cylinder in the distal direction.
  • the stopper When the needle tip 16b of the inner needle 16 moves to the proximal end side with respect to the stopper, the stopper is removed from the outer cylinder, so that the inner cylinder can move relative to the outer cylinder in the distal direction.
  • the engagement arm 66 protrudes from the distal end portion of the outer cylinder and opens, whereby the engagement of the engagement arm 66 with the catheter hub 14 is released, and the first The cover cylinder 62 can be detached from the catheter hub 14.
  • connection structure provided at the distal end portion of the first cover cylinder 62 may have a fitting portion that is detachably fitted to the inner peripheral portion of the proximal end of the catheter hub 14.
  • the fitting force is set so that the connection between the fitting portion and the catheter hub 14 is maintained until the protector 24 is extended to the maximum.
  • a shutter mechanism 68 that prevents the inner needle 16 from re-projecting from the tip of the protector 24 as the inner needle 16 is housed in the protector 24 may be provided at the tip of the first cover cylinder 62.
  • the shutter mechanism 68 can take various forms.
  • the shutter mechanism 68 includes, for example, a shutter housing 70 in which a needle insertion passage 70a is formed, and a shutter member 72 accommodated in the shutter housing 70.
  • the shutter member 72 is, for example, a leaf spring-like elastic member that is bent in a V shape, or a block-like member that can move within the shutter housing 70.
  • the user In the puncturing operation of puncturing the patient's skin with the catheter assembly 10A in the initial state shown in FIG. 1, the user (doctor, nurse, etc.) holds the needle hub 18. Then, the tip of the catheter assembly 10A (the tip of the catheter 12 through which the inner needle 16 is inserted) is pressed against the patient, and the skin is punctured toward the puncture target blood vessel. As a result, the inner needle 16 and the distal end portion of the catheter 12 are punctured into the skin.
  • the guide wire hub 22 is gripped to bring the guide wire hub 22 into the most advanced position of the movable range. Advance in the tip direction until.
  • the first engaging portion 38 moves in the engaging portion moving space from the position where the first protruding portion 40 of the first engaging portion 38 and the second protruding portion 58 of the second engaging portion 56 are engaged (FIG. 2).
  • the base end of the first protrusion 40 of the first engagement portion 38 is engaged with the base end of the notch 54.
  • the guide wire 20 is protruded from the distal end opening 16a of the inner needle 16 by a predetermined length. As the guide wire 20 moves in the distal direction and protrudes from the distal opening 16a, the guide wire 20 is inserted into the blood vessel.
  • the catheter hub 14 When the distal end portion of the guide wire 20 is inserted to the target position in the blood vessel, next, as shown in FIG. 3B, the catheter hub 14 is grasped while the position of the needle hub 18 is fixed, and the catheter member 15 (the catheter 12 and the catheter 15). The hub 14) is moved in the distal direction, thereby inserting the distal end of the catheter 12 to a target position in the blood vessel. At this time, the catheter 12 advances in the blood vessel following the outer surface of the guide wire 20 previously inserted into the blood vessel, that is, following the guide wire 20. Therefore, the distal end of the catheter 12 can be easily guided to the target position in the blood vessel.
  • the protector 24 extends by an amount corresponding to the axial relative movement distance between the catheter hub 14 and the needle hub 18 accompanying the movement of the catheter hub 14 in the distal direction.
  • the first cover cylinder 62 and the second cover cylinder 64 only the first cover cylinder 62 moves in the distal direction with respect to the needle hub 18, but only the second cover cylinder 64 or the first cover cylinder 64 Both the cover cylinder 62 and the second cover cylinder 64 may move in the distal direction with respect to the needle hub 18.
  • the guide wire hub 22 is grasped by pinching with a finger and the guide wire hub 22 is pulled in the proximal direction.
  • the wire 20 moves in the proximal direction, and the guide wire 20 is removed from the blood vessel.
  • the guide wire hub 22 reaches the most proximal position in the axial movable range with respect to the needle hub 18, the distal end portion of the guide wire 20 is located on the proximal end side with respect to the distal end opening 16 a of the inner needle 16. .
  • the most proximal position of the movable range of the guide wire hub 22 in the axial direction with respect to the needle hub 18 is the first engagement portion 38 provided on the needle hub 18 and the second engagement provided on the guide wire hub 22.
  • a joint portion 56 (see FIG. 2). That is, as the guide wire hub 22 is moved relative to the needle hub 18 in the proximal direction, the first engagement portion 38 is moved after the distal end portion of the guide wire 20 is retracted to the proximal end side with respect to the needle tip 16b. And the second engagement portion 56 engage with each other, further engagement of the guide wire hub 22 is prevented by the engagement action.
  • the guide wire hub 22 is further pulled with respect to the needle hub 18 by pulling the guide wire hub 22 in the proximal direction from the state where the guide wire hub 22 has reached the most proximal position of the movable range in the axial direction with respect to the needle hub 18.
  • the needle hub 18 moves in the proximal direction together with the guide wire hub 22 as shown in FIG. 4B.
  • the protector 24 extends and the inner needle 16 is removed from the catheter member 15.
  • the entire inner needle 16 including the needle tip 16b is accommodated in the protector 24. Further, the distal end portion of the guide wire 20 located on the proximal end side with respect to the needle tip 16 b is also accommodated in the protector 24. At this time, when the shutter mechanism 68 is provided, the shutter member 72 shields the needle insertion passage 70a as the needle tip 16b moves to the proximal end side with respect to the shutter member 72, thereby the protector. The re-projection of the inner needle 16 from the tip of 24 is prevented.
  • the catheter hub 14 and the protector 24 are connected. (Engagement, fitting, etc.) is released. As a result, the protector 24 is separated from the catheter member 15.
  • an infusion tube connector (not shown) is connected to the proximal end side of the catheter member 15 in a state where the inner needle 16 has been removed, and the infusion agent (medicine solution) is administered from the infusion tube to the patient.
  • the catheter assembly 10A when the guide wire hub 22 is moved backward with respect to the catheter 12 having the distal end inserted into the blood vessel, the distal end of the guide wire 20 is moved.
  • the needle hub 18 moves backward together with the guide wire hub 22 by engaging the first engagement portion 38 and the second engagement portion 56 after retreating to the proximal end side from the needle tip 16b (FIG. 4B). ).
  • the protector 24 covers the needle tip 16b of the inner needle 16 as the inner needle 16 is removed from the catheter 12, it is possible to more effectively prevent blood from being scattered.
  • the guide wire hub 22 has a housing portion 46 that covers a part of the outer peripheral surface of the needle hub 18, so that the user can easily hold the guide wire hub 22 and the catheter assembly 10A is in an initial state. It is easy to shorten the overall length. In order for a user to grasp the guide wire hub 22 by pinching it with a finger, it is desirable that the guide wire hub 22 covers the outer peripheral surface of the needle hub 18 at least at two opposite positions.
  • the first engagement portion 38 is provided on the outer peripheral surface of the needle hub 18, and the second engagement portion 56 is provided on the housing portion 46 of the guide wire hub 22.
  • the joining portion 38 and the second engaging portion 56 can be provided with a simple configuration.
  • the first engagement portion 38 has a form of a first projection portion 40 that protrudes from the outer peripheral surface of the needle hub 18, and the second engagement portion 56 is on the tip side of the first engagement portion 38. It has the form of the 2nd protrusion part 58 protruded in the circumferential direction.
  • the needle hub 18 has an inner shell portion 28 and an outer shell portion 30, and a cover housing chamber 34 for housing the protector 24 is formed between the inner shell portion 28 and the outer shell portion 30.
  • a cover housing chamber 34 for housing the protector 24 is formed between the inner shell portion 28 and the outer shell portion 30.
  • the wire holding portion 44 of the guide wire hub 22 enters the inner shell portion 28 of the needle hub 18 when the guide wire hub 22 is moved relative to the needle hub 18 in the distal direction.
  • the overall length of the catheter assembly 10A in the initial state can be further shortened.
  • the outer shell portion 30 of the needle hub 18b is provided with an engagement hole 80 extending in the axial direction as the first engagement portion 38. It has been.
  • the engagement hole 80 is a hole that penetrates the outer shell 30 in the thickness direction.
  • an engagement groove (a recessed portion with a bottom) may be provided instead of the engagement hole 80.
  • an engagement protrusion 82 protruding inward is provided as the second engagement portion 56 on the inner peripheral surface of the peripheral wall portion 50 of the guide wire hub 22b.
  • the engaging protrusions 82 are provided only in a part of the inner peripheral surface of the peripheral wall portion 50 in the circumferential direction, and are inserted into the engaging holes 80.
  • the engagement protrusion 82 can be displaced in the axial direction within the range of the engagement hole 80. In the initial state of the catheter assembly 10 ⁇ / b> B, the engagement protrusion 82 is located at the most proximal position of the engagement hole 80.
  • the needle hub 18b has an engaging portion moving space in which the second engaging portion 56 can move, and the distance that the second engaging portion 56 can move from one end to the other end of the engaging portion moving space is the guide wire 20.
  • the tip of the needle is longer than the distance that can protrude from the needle tip 16b.
  • the engaging portion moving space refers to the space from the tip of the second engaging portion 56 to the tip of the engaging hole 80 as the axial direction, and the radial direction space of the engaging hole 80 as the radial direction. Point to.
  • One end of the engaging portion moving space is located at the tip of the second engaging portion 56, and the other end of the engaging portion moving space is located at the tip of the engaging hole 80.
  • the distance that the second engagement portion 56 can move from one end to the other end of the engagement portion moving space is longer than the distance that the tip of the guide wire 20 can protrude from the needle tip 16b. Can be reliably pulled into.
  • the guide wire hub 22b is provided with an extending portion 84 that extends from the distal end of the peripheral wall portion 50 in the distal direction, and an operation tab 86 that protrudes upward from the distal end of the extending portion 84. Yes.
  • the operation tab 86 may be gripped, or the finger holder 60 may be gripped.
  • the extension part 84 may be eliminated and the operation tab 86 may be protruded from the outer peripheral surface of the peripheral wall part 50.
  • the method of using the catheter assembly 10B is the same as that of the catheter assembly 10A. That is, in the use of the catheter assembly 10B, after puncturing the patient's skin with the inner needle 16 and the distal end portion of the catheter 12, the guide wire hub 22b is moved in the distal direction to the most distal position of the movable range as shown in FIG. 7A. Proceed. In this case, the engagement protrusion 82 provided on the guide wire hub 22b moves to the engagement hole 80 provided on the needle hub 18b or the distal end side in the engagement groove. That is, the engagement protrusion 82 is engaged from the position (FIG.
  • the guide wire 20 is protruded from the distal end opening 16a of the inner needle 16 by a predetermined length. As the guide wire 20 moves in the distal direction and protrudes from the distal opening 16a, the guide wire 20 is inserted into the blood vessel.
  • the catheter hub 14 is grasped and the catheter member 15 (the catheter 12 and the catheter hub 14) is moved in the distal direction. Is inserted to the target position in the blood vessel.
  • the first engagement portion 38 (engagement hole 80 or engagement groove) provided in the needle hub 18b and the second engagement portion 56 (engagement) provided in the guide wire hub 22b.
  • the mating protrusion 82 defines the most proximal position of the movable range of the guide wire hub 22b in the axial direction with respect to the needle hub 18b.
  • the guide wire hub 22b is moved relative to the needle hub 18b in the proximal direction, the distal end of the guide wire 20 is retracted to the proximal end side with respect to the needle tip 16b, and then the engagement hole 80 or When the engaging groove and the engaging protrusion 82 are engaged, further relative movement of the guide wire hub 22b in the proximal direction is prevented by the engaging action.
  • the guide wire hub 22b is further pulled with respect to the needle hub 18b by pulling the guide wire hub 22b in the proximal direction from the state where the guide wire hub 22b has reached the most proximal position of the axial movable range with respect to the needle hub 18b.
  • the needle hub 18b moves in the proximal direction together with the guide wire hub 22b as shown in FIG. 8B.
  • the protector 24 extends and the inner needle 16 is removed from the catheter member 15.
  • the catheter assembly 10B As described above, also with the catheter assembly 10B according to the present embodiment, when the guide wire hub 22b is moved backward relative to the catheter 12, the distal end portion of the guide wire 20 is accommodated in the inner needle 16, and the inner needle 16 is removed from the catheter 12, and the inner needle 16 is stored in the protector 24. Therefore, it is possible to prevent blood adhering to the guide wire 20 from being scattered.
  • the first engagement portion 38 is an engagement hole 80 or an engagement groove provided on the outer peripheral surface of the needle hub 18b
  • the second engagement portion 56 is the housing portion 46 (peripheral wall).
  • Engagement protrusion 82 protruding inward from the inner peripheral surface of the portion 50).
  • the needle hub 18c has an inner shell portion 28 and an outer shell portion 30, and the inner shell portion 28 and the outer shell portion 30 of the needle hub 18 of the catheter assembly 10A. It is formed longer in the proximal direction than (see FIG. 1).
  • the inner shell portion 28, the outer shell portion 30 and the connecting portion 32 constitute a trunk portion 90.
  • the trunk portion 90 of the needle hub 18c passes through the proximal end wall 48 of the guide wire hub 22c, and a flange portion 92 is connected to the proximal end portion of the trunk portion 90.
  • the base end portion of the body portion 90 is provided with two extending portions 94 extending in the base end direction, and a notch portion 95 is formed between the extending portions 94. .
  • the two extending portions 94 penetrate through a through hole 96 formed in the proximal end wall 48 of the guide wire hub 22c.
  • the flange portion 92 is connected to the base end portion (free end portion) of the extending portion 94.
  • the flange portion 92 is formed in a circular ring shape, and an outward engagement protrusion 98 formed on the base end outer peripheral portion of the extending portion 94 is formed on the inner peripheral portion of the flange portion 92.
  • the outer diameter of the flange portion 92 is larger than the outer diameter of the trunk portion 90.
  • the flange portion 92 constitutes the first engaging portion 38, and the proximal end portion 23 (proximal end wall 48) of the guide wire hub 22 c is engaged with the first engaging portion 38.
  • the possible 2nd engaging part 56 is comprised.
  • the needle hub 18c has an engaging portion moving space in which the second engaging portion 56 (base end wall 48) can move, and the second engaging portion 56 can move from one end to the other end of the engaging portion moving space.
  • the distance is longer than the distance at which the tip of the guide wire 20 can protrude from the needle tip 16b.
  • the engaging portion moving space refers to the space from the front end of the notch portion 95 to the front end of the flange portion 92 as the axial direction, and the radial direction space of the notch portion 95 as the radial direction. Point to.
  • One end of the engaging portion moving space is located at the tip of the notch 95, and the other end of the engaging portion moving space is located at the tip of the flange portion 92.
  • the distance that the second engaging portion 56 (base end wall 48) can move from one end to the other end of the engaging portion moving space is longer than the distance that the tip of the guide wire 20 can protrude from the needle tip 16b. The wire 20 can be reliably pulled into the inner needle 16.
  • the method of using the catheter assembly 10C is the same as that of the catheter assembly 10A. That is, in the use of the catheter assembly 10C, after puncturing the patient's skin with the inner needle 16 and the distal end portion of the catheter 12, the guide wire hub 22c is moved in the distal direction as shown in FIG. 11A. In this case, the extending portion 94 of the needle hub 18c projects in the proximal direction from the proximal end portion 23 of the guide wire hub 22c. That is, the base end wall 48 of the second engagement portion 56 is moved from the position where the base end of the base end wall 48 of the second engagement portion 56 is engaged with the tip end portion of the flange portion 92 to move the base end wall 48 of the second engagement portion 56.
  • the guide wire 20 is protruded from the distal end opening 16a of the inner needle 16 by a predetermined length. As the guide wire 20 moves in the distal direction and protrudes from the distal opening 16a, the guide wire 20 is inserted into the blood vessel.
  • the catheter hub 14 is grasped and the catheter member 15 (the catheter 12 and the catheter hub 14) is moved in the distal direction. Is inserted to the target position in the blood vessel.
  • the first engagement portion 38 (flange portion 92) provided on the needle hub 18c and the second engagement portion 56 (base of the guidewire hub 22c) provided on the guidewire hub 22c.
  • the end portion 23) defines the most proximal end position of the movable range in the axial direction of the guide wire hub 22c with respect to the needle hub 18c. That is, as the guide wire hub 22c is moved in the proximal direction relative to the needle hub 18c, the flange portion 92 and the guide wire are moved after the distal end portion of the guide wire 20 is retracted to the proximal end side with respect to the needle tip 16b. When the proximal end portion 23 of the hub 22c is engaged, further relative movement of the guide wire hub 22c in the proximal direction is prevented by the engaging action.
  • the guide wire hub 22c is further pulled with respect to the needle hub 18c by pulling the guide wire hub 22c in the proximal direction from the state where the guide wire hub 22c reaches the most proximal position of the axial movable range with respect to the needle hub 18c.
  • the needle hub 18c moves in the proximal direction together with the guide wire hub 22c.
  • the protector 24 extends and the inner needle 16 is removed from the catheter member 15.
  • the catheter assembly 10C As described above, also with the catheter assembly 10C according to the present embodiment, when the guide wire hub 22c is moved backward relative to the catheter 12, the distal end portion of the guide wire 20 is accommodated in the inner needle 16, and the inner needle 16 is removed from the catheter 12, and the inner needle 16 is stored in the protector 24. Therefore, it is possible to prevent blood adhering to the guide wire 20 from being scattered.
  • the needle hub 18c has a trunk portion 90 inserted into the guide wire hub 22c, and a flange portion 92 provided at the proximal end portion of the trunk portion 90, and the flange portion 92 is
  • the first engagement portion 38 is configured, and the proximal end portion 23 of the guide wire hub 22 c configures the second engagement portion 56.
  • the most proximal end position of the movable range in the axial direction of the guide wire hub 22c with respect to the needle hub 18c is reliably defined under the engaging action of the flange portion 92 and the proximal end portion 23 of the guide wire hub 22c.
  • the guide wire hubs 22, 22 b, and 22 c are fixed to the proximal end portion of the guide wire 20.
  • the guide wire hubs 22, 22 b, and 22 c are the proximal end portions of the guide wire 20. It does not need to be fixed to.
  • the end portion of the guide wire 20 led out from the proximal end side of the inner needle 16 is fixed to the needle hubs 18, 18 b, 18 c or the inner needle 16.
  • the guide wire hubs 22, 22 b and 22 c are guided and supported so that the guide wires 20 extending in the proximal direction from the needle hubs 18, 18 b and 18 c are folded back toward the inner needle 16 and the guide wires 20 are slidable.
  • a guide portion having the shape of a curved hole is provided.
  • the guide wire 20 is inserted through the guide portion. In such a configuration, after the inner needle 16 and the distal end portion of the catheter 12 are punctured into the patient's skin, the guide wire 20 is moved forward when the guide wire hubs 22, 22b, 22c are advanced relative to the needle hubs 18, 18b, 18c.
  • the guide wire 20 As the guide wire 20 is pushed in the distal direction by the guide portion while sliding in the guide portion, the guide wire 20 advances with respect to the inner needle 16. As a result, the guide wire 20 is projected from the distal end opening 16a of the inner needle 16 by a predetermined length. Further, the catheter hub 14 is advanced with respect to the needle hubs 18, 18 b, 18 c to insert the catheter 12 to a target position in the blood vessel, and the guide wire hubs 22, 22 b are used to remove the inner needle 16 from the catheter 12. When the guide wire 20 is pulled back in the proximal direction by the guide portions of the guide wire hubs 22, 22 b, 22 c, the guide wire 20 is retracted with respect to the inner needle 16.
  • the guide wire hubs 22, 22 b and 22 c reach the most proximal end position of the movable range with respect to the needle hubs 18, 18 b and 18 c. Therefore, when the guide wire hubs 22, 22b, 22c are further pulled in the proximal direction, the needle hubs 18, 18b, 18c are pulled by the guide wire hubs 22, 22b, 22c, whereby the inner needle 16 is removed from the catheter 12.
  • the first engaging portion 38 may be provided on the inner needle 16 or the needle hub 18, 18b, 18c, and the second engaging portion 56 may be provided on the guide wire 20.
  • the first engagement portion 38 is a reduced diameter portion or an inward bulging portion provided on the inner surface of the inner needle 16 or the needle hubs 18, 18b, 18c
  • the second engagement portion 56 is A diameter-enlarged portion or an outwardly bulged portion that is provided on the outer surface of the guide wire 20 and can be engaged with the reduced diameter portion or the inwardly bulged portion.
  • the guide wire hubs 22, 22 b, and 22 c are advanced with respect to the needle hubs 18, 18 b, and 18 c after the inner needle 16 and the distal end portion of the catheter 12 are punctured into the patient's skin, the guide wires 20 are moved forward. Advances with respect to the inner needle 16. As a result, the guide wire 20 is projected from the distal end opening 16a of the inner needle 16 by a predetermined length. Further, the catheter hub 14 is advanced with respect to the needle hubs 18, 18 b, 18 c to insert the catheter 12 to a target position in the blood vessel, and the guide wire hubs 22, 22 b are used to remove the inner needle 16 from the catheter 12.
  • the guide wire 20 is retracted relative to the inner needle 16.
  • the distal end portion of the guide wire 20 is accommodated in the inner needle 16.
  • the enlarged diameter portion or the outward bulging portion provided in the guide wire 20 is the inner needle 16 or the needle hubs 18, 18 b, 18 c.

Abstract

Un ensemble cathéter (10A) est pourvu d'un cathéter (12), d'une embase de cathéter (14), d'une aiguille interne (16), d'un raccord d'aiguille (18), d'un fil de guidage (20), et d'un embout de fil de guidage (22). Le raccord d'aiguille (18) ou l'aiguille interne (16) est pourvu d'une première partie de mise en prise (38), et l'embout de fil de guidage (22) ou le fil de guidage (20) est pourvu d'une seconde partie de mise en prise (56). Lorsque le fil de guidage (20) et l'embout de fil de guidage (22) sont amenés à se déplacer l'un par rapport à l'autre, dans la direction base-extrémité, par rapport au cathéter (12), la pointe du fil de guidage (20) entre et est logée à l'intérieur de l'aiguille interne (16), et ensuite la première partie de mise en prise (38) et la seconde partie de mise en prise (56) viennent s'accoupler l'une avec l'autre.
PCT/JP2016/055806 2015-03-23 2016-02-26 Ensemble cathéter WO2016152377A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015-059348 2015-03-23
JP2015059348 2015-03-23

Publications (1)

Publication Number Publication Date
WO2016152377A1 true WO2016152377A1 (fr) 2016-09-29

Family

ID=56978984

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2016/055806 WO2016152377A1 (fr) 2015-03-23 2016-02-26 Ensemble cathéter

Country Status (1)

Country Link
WO (1) WO2016152377A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020522303A (ja) * 2017-05-26 2020-07-30 パイパー・アクセス、エルエルシー カテーテル送達デバイス、システム、及び方法
JP2021510338A (ja) * 2018-01-11 2021-04-22 ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company ガイドワイヤー前送り要素を備えたカテーテルシステム

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013529111A (ja) * 2010-05-14 2013-07-18 シー・アール・バード・インコーポレーテッド カテーテル配置装置および方法
US20140214005A1 (en) * 2013-01-30 2014-07-31 Vascular Pathways, Inc. Systems and methods for venipuncture and catheter placement

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013529111A (ja) * 2010-05-14 2013-07-18 シー・アール・バード・インコーポレーテッド カテーテル配置装置および方法
US20140214005A1 (en) * 2013-01-30 2014-07-31 Vascular Pathways, Inc. Systems and methods for venipuncture and catheter placement

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2020522303A (ja) * 2017-05-26 2020-07-30 パイパー・アクセス、エルエルシー カテーテル送達デバイス、システム、及び方法
JP7237858B2 (ja) 2017-05-26 2023-03-13 パイパー・アクセス、エルエルシー カテーテル送達デバイス、システム、及び方法
JP2021510338A (ja) * 2018-01-11 2021-04-22 ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company ガイドワイヤー前送り要素を備えたカテーテルシステム
JP7260550B2 (ja) 2018-01-11 2023-04-18 ベクトン・ディキンソン・アンド・カンパニー ガイドワイヤー前送り要素を備えたカテーテルシステム

Similar Documents

Publication Publication Date Title
JP6966592B2 (ja) カテーテル組立体
KR102560266B1 (ko) 미드라인 카테터 배치 장치
JP4906508B2 (ja) 留置針組立体
JP6166256B2 (ja) 医療用針
WO2014162377A1 (fr) Ensemble sonde
US11318285B2 (en) Catheter assembly
US10632282B2 (en) Catheter assembly
WO2017051802A1 (fr) Ensemble cathéter
WO2017073658A1 (fr) Ensemble d'élément de préhension et de seringue
JP2017176455A (ja) カテーテル組立体
WO2016152377A1 (fr) Ensemble cathéter
JP7174945B2 (ja) 留置針装置
JP4812472B2 (ja) 留置針組立体
JP5967994B2 (ja) 医療用針
JP4648615B2 (ja) 翼付きシールドを有する医療用針装置
JPWO2015133279A1 (ja) カテーテル組立体
WO2014162381A1 (fr) Sonde à demeure et ensemble sonde
US11000650B2 (en) Protector and medical needle assembly
US20200009328A1 (en) Syringe assembly
WO2013140983A1 (fr) Aiguille médicale
WO2016152378A1 (fr) Ensemble cathéter
JP2018143421A (ja) カテーテル組立体
WO2020059388A1 (fr) Ensemble cathéter
JP6166358B2 (ja) カテーテル組立体
WO2017170502A1 (fr) Seringue

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: 16768280

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

NENP Non-entry into the national phase

Ref country code: JP

122 Ep: pct application non-entry in european phase

Ref document number: 16768280

Country of ref document: EP

Kind code of ref document: A1