WO2013180234A1 - Indwelling needle device - Google Patents

Indwelling needle device Download PDF

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Publication number
WO2013180234A1
WO2013180234A1 PCT/JP2013/065082 JP2013065082W WO2013180234A1 WO 2013180234 A1 WO2013180234 A1 WO 2013180234A1 JP 2013065082 W JP2013065082 W JP 2013065082W WO 2013180234 A1 WO2013180234 A1 WO 2013180234A1
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WO
WIPO (PCT)
Prior art keywords
shield
needle
unit
hub
inner hub
Prior art date
Application number
PCT/JP2013/065082
Other languages
French (fr)
Japanese (ja)
Inventor
藤井亮至
植松雷太
Original Assignee
株式会社ジェイ・エム・エス
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 株式会社ジェイ・エム・エス filed Critical 株式会社ジェイ・エム・エス
Publication of WO2013180234A1 publication Critical patent/WO2013180234A1/en

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    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters

Definitions

  • the present invention includes a soft outer needle and a hard inner needle, and can puncture a patient with the tip of the inner needle protruding from the tip of the outer needle, and then the inner needle can be retracted from the outer needle. It is related with the indwelling needle apparatus comprised as follows.
  • Indwelling needle devices are widely used for treatments such as infusion, blood transfusion, and extracorporeal blood circulation.
  • a metal needle is left in the blood vessel, the blood vessel may be damaged. Therefore, an indwelling needle device having a soft outer needle and a hard inner needle is known. With the tip of the inner needle protruding from the tip of the outer needle, the outer needle and the inner needle are punctured into the patient's blood vessel, and then the inner needle is retracted from the outer needle and only the outer needle is left in the patient. The indwelling soft outer needle is unlikely to damage the patient's blood vessels.
  • FIG. 7 is a perspective view of an example of such a conventional indwelling needle device 900 (see, for example, Patent Document 1) as viewed from above.
  • FIG. 8 is a conventional view along a vertical plane including line 8-8 in FIG. It is arrow sectional drawing of the indwelling needle apparatus 900.
  • FIG. 7 For convenience of explanation, the side where the patient is punctured (the left side of the paper surface of FIGS. 7 and 8) is called the “front side”, and the opposite side is called the “rear side”.
  • the indwelling needle device 900 includes a shield 920 including a shield cylinder 921 having a substantially cylindrical shape and an outer hub 925 fixed to one end (front end) thereof.
  • a soft outer needle 930 is fixed to the front end of the outer hub 925.
  • a pair of blades 929a and 929b are provided on the outer peripheral surface of the shield tube 921 near the outer hub 925 side end.
  • the wings 929a and 929b have flexibility and can swing up and down.
  • An inner hub 940 is inserted into the lumen of the shield 920.
  • a metal hard inner needle 950 is fixed to the front end of the inner hub 940, and one end of a flexible tube 960 is connected to the rear end of the inner hub 940.
  • the inner needle 950 and the tube 960 communicate with each other via a longitudinal passage 943 that penetrates the inner hub 940 in the front-rear direction.
  • the shield tube 921, the outer hub 925, the outer needle 930, and the wings 929a and 929b constitute an outer unit 901 of the indwelling needle device 900.
  • the inner hub 940, the inner needle 950, and the tube 960 constitute an inner unit 902 of the indwelling needle device 900.
  • the inner unit 902 is inserted into the outer unit 901 so as to be movable in the longitudinal direction of the shield 920 (that is, the front-rear direction).
  • the inner hub 940 is located on the front end side of the lumen of the shield 920, the inner needle 950 held by the inner hub 940 passes through the outer needle 930, and the tip of the inner needle 950 is the outer needle 930. It protrudes from the tip of the outside.
  • This position of the inner unit 902 relative to the outer unit 901 is referred to as an “initial position”.
  • FIG. 9 is a perspective view of the stopper 970.
  • An approximately semi-cylindrical insertion portion 972 and a pair of fixing portions 973 extend from the substantially semi-cylindrical base portion 971.
  • the insertion portion 972 is disposed between the pair of fixing portions 973 and these are parallel to each other.
  • the insertion portion 972 of the stopper 970 is inserted from the rear end of the shield tube 921.
  • the distal end of the insertion portion 972 collide with the rear end of the inner hub 940 and pushing the inner hub 940 forward, the inner unit 902 can be disposed at the initial position.
  • the indwelling needle device 900 is used as follows.
  • the inner needle 950 and the outer needle 930 are punctured into the patient's blood vessel while the inner unit 902 is held at the initial position (puncturing operation). It is necessary to prevent the inner needle 950 from being stored in the outer needle 930 due to the reaction force that the inner needle 950 receives from the patient during puncturing. For this reason, the puncturing operation needs to be performed while holding the stopper 970. Accordingly, the stopper 970 and the inner unit 902 are not displaced with respect to the outer unit 901, and the inner unit 902 is maintained at the initial position.
  • the stopper 970 is removed from the shield 920, and then the tube 960 is withdrawn from the shield 920 (retraction operation).
  • the stopper 970 may be removed from the shield 920 at the same time as the tube 960 is pulled out.
  • the inner unit 902 moves backward with respect to the outer unit 901, and the inner needle 950 is housed in the shield 920 as shown in FIG.
  • the indwelling needle device 900 is fixed to the patient using an adhesive tape or the like.
  • the indwelling needle device 900 is indwelled with only the soft outer needle 930 punctured by the patient.
  • the stopper 970 is used only to maintain the inner unit 902 at the initial position in the puncturing operation for puncturing the patient with the inner needle 950 and the outer needle 930.
  • the stopper 970 is removed from the shield 920 prior to or together with the backward operation for moving the inner unit 902 toward the backward position.
  • the stopper 970 by providing the stopper 970, the number of parts constituting the indwelling needle device 900 increases, and the cost of the indwelling needle device 900 increases.
  • the stopper 970 inserted into the shield 920 may fall out of the shield 920 due to vibration or the like during the transfer of the indwelling needle device 900.
  • An object of the present invention is to solve the problems of the above-described conventional indwelling needle device, to reduce the possibility of erroneous operation, to reduce the number of parts, and to provide an indwelling needle device in which a stopper does not fall out during transfer.
  • An indwelling needle device includes a shield having a lumen, an outer unit including a soft outer needle fixed to the front end of the shield, and an inner portion partially disposed in the lumen of the shield.
  • the inner hub includes an operation portion on a side opposite to the inner needle. When the inner unit is arranged at the initial position, the operation unit is located outside the shield.
  • the indwelling needle device of the present invention does not include an independent member corresponding to the stopper of the conventional indwelling needle device. If the operation unit located outside the shield is moved rearward with respect to the shield, the inner unit can be moved from the initial position to the retracted position. Therefore, the possibility of erroneous operation of forgetting to move the inner unit to the retracted position is reduced.
  • the indwelling needle device of the present invention does not include an independent member corresponding to the stopper of the conventional indwelling needle device, the number of parts constituting the indwelling needle device is reduced. This is advantageous for reducing the cost of the indwelling needle device.
  • the indwelling needle device of the present invention does not include an independent member corresponding to the stopper of the conventional indwelling needle device, the stopper does not fall off from the shield due to vibration during transfer.
  • FIG. 1 is a perspective view seen from above of an indwelling needle device according to an embodiment of the present invention in which an inner unit is in an initial position.
  • FIG. 2 is a cross-sectional view of the indwelling needle device according to the embodiment of the present invention along the vertical plane including line 2-2 in FIG.
  • FIG. 3A is a perspective view of an inner hub used in the indwelling needle device according to the embodiment of the present invention.
  • FIG. 3B is a cross-sectional view of the inner hub used in the indwelling needle device according to the embodiment of the present invention along the plane including the line 3B-3B in FIG. 3A.
  • FIG. 4 is a perspective view seen from above the indwelling needle device according to the embodiment of the present invention in which the inner unit is in the retracted position.
  • FIG. 5 is a cross-sectional view of the indwelling needle device according to the embodiment of the present invention along the vertical plane including line 5-5 in FIG.
  • FIG. 6 is a perspective view seen from above of the indwelling needle device according to the embodiment of the present invention, in which the inner unit is in the retracted position, the inner hub is divided by a notch, and the rear side portion is removed. is there.
  • FIG. 7 is a perspective view seen from above of a conventional indwelling needle device in which the inner unit is in the initial position.
  • FIG. 8 is a cross-sectional view of the conventional indwelling needle device taken along the vertical plane including line 8-8 in FIG.
  • FIG. 9 is a perspective view of a stopper used in the conventional indwelling needle device shown in FIG. 10 is a cross-sectional view of the conventional indwelling needle device shown in FIG. 7 along the same plane as FIG. 8, with the inner unit in the retracted position.
  • An indwelling needle device includes a shield having a lumen, an outer unit including a soft outer needle fixed to the front end of the shield, and an inner portion partially disposed in the lumen of the shield.
  • the inner hub includes an operation portion on a side opposite to the inner needle. When the inner unit is arranged at the initial position, the operation unit is located outside the shield.
  • the indwelling needle device of the present invention when the inner unit moves to the retracted position, at least a part of a portion of the inner hub located outside the shield is removed, including the operation portion. It is preferable that Thereby, it is possible to prevent a trouble that an unintended external force acts on a portion of the inner hub located outside the shield and the outer needle comes out of the patient.
  • a notch for facilitating the removal is formed in the inner hub. This is advantageous for facilitating the division of the inner hub.
  • FIG. 1 is a perspective view seen from above of an indwelling needle device 100 according to an embodiment of the present invention in which an inner unit is in an initial position.
  • an orthogonal coordinate system is set in which the longitudinal direction of the indwelling needle device 100 is the Z axis, the horizontal axis orthogonal to the Z axis, and the vertical axis are the X axis and Y axis, respectively.
  • the Y-axis arrow side (that is, the upper side in FIG. 1) is called “upper side”, and the opposite side is called “lower side”.
  • the “horizontal direction” and the “vertical direction” do not mean the directions when the indwelling needle device 100 is actually used.
  • FIG. 2 is a cross-sectional view of the indwelling needle device 100 taken along the vertical plane (YZ plane) including the line 2-2 in FIG.
  • the indwelling needle device 100 includes a shield 20.
  • the shield 20 includes a shield cylinder 21 and an outer hub 25 fixed to one end (front end) of the shield cylinder 21.
  • the shield cylinder 21 has a substantially cylindrical shape with a constant inner diameter.
  • a locking protrusion 22 that is continuous in the circumferential direction is formed on the inner peripheral surface of the shield tube 21 in the vicinity of the end (rear end) opposite to the outer hub 25.
  • the outer hub 25 has a substantially funnel shape, and a soft outer needle 30 is fixed to an end (front end) opposite to the shield tube 21.
  • the outer needle 30 has a substantially cylindrical shape.
  • the material of the shield tube 21 and the outer hub 25 is not particularly limited, but is preferably a hard material.
  • the shield cylinder 21 and the outer hub 25 be transparent or translucent because the liquid (chemical liquid or blood) in the inner cavity 24 of the shield 20 or the inner hub 40 can be seen through.
  • the material of the outer needle 30 is not particularly limited, but a soft material is preferable.
  • a fluorine resin such as polypropylene, polyurethane elastomer, polytetrafluoroethylene, or the like can be used.
  • the outer needle 30 is transparent or translucent because the liquid (chemical liquid or blood) in the lumen and the inner needle 50 can be seen through.
  • the outer hub 25 and the outer needle 30 may be integrally formed using the soft material described above.
  • Reference numerals 29a and 29b are wings extending substantially parallel to the X axis.
  • the wings 29 a and 29 b are provided on a substantially cylindrical fixing member 28.
  • the material of the blades 29a and 29b is not particularly limited, but a soft material is preferable.
  • polypropylene, vinyl chloride, polyethylene, olefin-based or polystyrene-based thermoplastic elastomers, and the like can be used.
  • the wings 29a and 29b may be formed integrally with the shield 20.
  • An inner hub 40 is inserted into the inner cavity 24 of the shield 20 so as to be movable in the longitudinal direction of the shield 20 (that is, the Z-axis direction).
  • FIG. 3A is a perspective view of the inner hub 40
  • FIG. 3B is a cross-sectional view of the inner hub 40 along the vertical plane (YZ plane) including the line 3B-3B in FIG. 3A.
  • the inner hub 40 of the present embodiment has a shape that approximates that the inner hub 940 (see FIG. 8) and the stopper 970 (see FIG. 9) of the conventional indwelling needle device 900 are integrated.
  • a portion of the inner hub 40 corresponding to the conventional inner hub 940 is referred to as an inner hub body 140.
  • the inner hub main body 140 has a front portion 41 having a conical outer surface at one end (front end) and a rear portion 42 having a cylindrical outer surface at the other end.
  • a longitudinal passage 43 passes through the inner hub main body 140 from the front portion 41 to the rear portion 42 along the central axis 140 a of the inner hub main body 140.
  • An annular groove 44 continuous in the circumferential direction is formed on the outer peripheral surface of the inner hub main body 140 between the front portion 41 and the rear portion 42.
  • a large diameter portion 45 and a small diameter portion 46 are formed in this order between the annular groove 44 and the front portion 41 from the annular groove 44 side.
  • the small diameter portion 46 is adjacent to the front portion 41, and the outer diameter of the small diameter portion 46 is substantially the same as the maximum diameter of the front portion 41 and is smaller than the outer diameter of the large diameter portion 45.
  • the front portion 41, the small diameter portion 46, and the large diameter portion 45 are formed with a transverse passage 47 that passes through them in the diameter direction (a direction orthogonal to the central axis 140 a of the inner hub main body 140).
  • the transverse passage 47 intersects and communicates with the longitudinal passage 43.
  • the elastic piece 48 is arranged at equiangular intervals with respect to the central axis 140a.
  • the elastic piece 48 extends substantially parallel to the central axis 140a.
  • a fitting groove 48 a and a tapered surface 48 b are formed on the surface opposite to the rear portion 42 of the elastic piece 48.
  • the fitting groove 48 a is a recess (groove) along the circumferential direction of the inner hub main body 140.
  • the tapered surface 48b is adjacent to the fitting groove 48a on the free end side of the elastic piece 48, and forms a part of a conical surface having a large outer diameter on the fitting groove 48a side.
  • connection part 72 is a strip-shaped thin plate.
  • a notch 75 that is locally thinned is formed at the boundary between the elastic piece 48 and the connecting portion 72.
  • a pair of fixing portions 73 extend from the operation portion 71 toward the inner hub main body 140 so as to sandwich the connecting portion 72.
  • the fixing portion 73 is a strip-shaped thin plate, and can be easily elastically deformed in a direction in which the fixing portion 73 comes in contact with or separates from the connecting portion 72.
  • a hard material is preferable,
  • a polycarbonate, a polypropylene, polyethylene etc. can be used.
  • the inner needle 50 is inserted into the longitudinal passage 43 from the front portion 41 side of the inner hub main body 140 and is held by the inner hub 40.
  • the rear portion 42 is inserted into the flexible tube 60 and the inner hub 40 and the tube 60 are connected.
  • the inner needle 50 and the tube 60 are communicated through the longitudinal passage 43 of the inner hub body 140.
  • the end opposite to the inner hub body 140 of the tube 60 is connected to, for example, an infusion circuit for performing infusion.
  • the inner needle 50 is made of a metal hard material.
  • the inner needle 50 has a substantially cylindrical shape, and the tip is processed sharply.
  • the material of the tube 60 is not particularly limited, but is preferably a soft material.
  • a resin material such as vinyl chloride can be used.
  • the O-ring 49 is attached to the annular groove (see FIGS. 3A and 3B) of the inner hub main body 140.
  • the O-ring 49 is in close contact with the inner peripheral surface of the shield cylinder 21, and in the inner cavity 24 of the shield 20, the drug solution or blood on the outer needle 30 side of the O-ring 49 leaks to the tube 60 side of the O-ring 49. prevent.
  • the material of the O-ring 49 is not particularly limited, but is preferably a flexible material that can be elastically deformed. For example, polyisoprene rubber, silicone rubber, thermoplastic elastomer, or the like can be used.
  • the shield 20, the outer needle 30 fixed to the shield 20, the wings 29 a and 29 b, and the fixing member 28 constitute an outer unit 101 of the indwelling needle device 100.
  • the inner hub 40, the inner needle 50, and the tube 60 constitute an inner unit 102 of the indwelling needle device 100.
  • the inner unit 102 is inserted into the outer unit 101 so as to be movable in the longitudinal direction of the shield 20 (that is, the front-rear direction).
  • the inner hub main body 140 is located on the front end side of the inner cavity 24 of the shield 20, the inner needle 50 held by the inner hub 40 penetrates the outer needle 30, and the tip thereof is the outer needle 30. Projects outward from the tip.
  • the operation unit 71 is located behind the rear end of the shield 20 and is exposed to the outside.
  • fixed part 73 is arrange
  • FIG. 4 is a perspective view seen from above the indwelling needle device 100 in which the inner unit 102 is in the retracted position.
  • FIG. 5 is a cross-sectional view of the indwelling needle device 100 along the vertical plane (YZ plane) including the line 5-5 in FIG.
  • the flow path from the outer needle 30 to the tube 60 includes a first flow path that sequentially passes through the lumen of the inner needle 50 and the longitudinal passage 43 of the inner hub body 140, the inner surface of the shield 20, and the inner needle. 50 and the outer surface of the inner hub main body 140, the transverse passage 47 of the inner hub main body 140, and the second flow path passing through the longitudinal passage 43 of the inner hub main body 140 in this order. Or blood can be shed.
  • the inner unit 102 moves from the initial position shown in FIGS. 1 and 2 to the retracted position shown in FIGS. Can move.
  • the indwelling needle device 100 of the present embodiment is delivered to a medical institution such as a hospital in a state where the inner unit 102 is disposed at the initial position (FIGS. 1 and 2).
  • a medical institution such as a hospital
  • the inner unit 102 is positioned at the initial position.
  • the operator moves the inner needle 50 and the outer needle 30 with the inner unit 102 in the initial position and the inner needle 50 protruding from the tip of the outer needle 30.
  • the patient's blood vessel is punctured (puncture operation).
  • the inner needle 50 receives a reaction force opposite to the puncturing direction. This reaction force acts to move the inner unit 102 toward the retracted position with respect to the outer unit 101.
  • An indwelling needle is held while holding a portion of the inner hub 40 located outside the shield 20, that is, the operation portion 71 or the pair of fixing portions 73 so that the inner unit 102 does not move toward the retracted position with respect to the outer unit 101.
  • the device 100 is punctured.
  • the inner unit 102 is retracted (retracting operation). For example, while holding the outer unit 101 with one hand (for example, a hand different from the one holding the indwelling needle device 100 by a puncturing operation) so that the outer unit 101 is not displaced with respect to the patient, The operation unit 71 of the inner hub 40 may be held and the inner unit 102 may be pulled out from the outer unit 101. The inner unit 102 moves rearward together with the operation unit 71.
  • a locking projection 22 is formed on the inner peripheral surface near the rear end of the shield tube 21.
  • the inner hub main body 140 moves to the locking protrusion 22, and a tapered surface 48 b (see FIGS. 3A and 3B) formed on the outer surface of the elastic piece 48 of the inner hub main body 140 slides on the locking protrusion 22.
  • the elastic piece 48 is elastically deformed toward the rear portion 42 side.
  • the taper surface 48b gets over the locking protrusion 22, the elastic piece 48 is elastically recovered, and the locking protrusion 22 is fitted into the fitting groove 48a.
  • the inner unit 102 moves to the retracted position shown in FIGS.
  • FIG. 5 is a perspective view of the indwelling needle device 100 in which the inner hub 40 is divided by a notch 75 and a portion behind the notch 75 of the inner hub 40 is removed.
  • an adhesive tape is applied to the patient's skin from above the outer unit 101, and the indwelling needle device 100 is fixed to the patient. Only the outer needle 30 is indwelled while being punctured by the patient.
  • the inner unit 102 is in the retracted position, the hard inner needle 50 does not exist in the flexible outer needle 30, so that even if the posture of the indwelling needle device 100 with respect to the patient changes temporarily due to movement of the patient, the outer needle 30 does not damage the patient's blood vessels or the like.
  • the adhesive tape for fixing the outer unit 101 is peeled off from the patient, and the outer needle 30 is pulled out from the patient. Even if the tube 60 is pushed and pulled with respect to the outer unit 101, the fitting state between the fitting groove 48a of the inner hub main body 140 and the locking projection 22 of the shield tube 21 is not released. That is, the inner needle 50 cannot protrude again from the tip of the outer needle 30, and the inner unit 102 cannot be pulled out from the outer unit 101. Accordingly, it is possible to prevent the hard inner needle 50 from being punctured by mistake and the used indwelling needle device 100 from being reused by mistake. The used indwelling needle device 100 is discarded.
  • the indwelling needle device 100 is punctured while holding the portion of the inner hub 40 located outside the shield 20 (for example, the operation unit 71 and the pair of fixing units 73). Can do. Therefore, even if the inner needle 50 receives a reaction force in the puncturing operation, the inner unit 102 does not move toward the retracted position and remains at the initial position.
  • the configuration (see FIG. 1) of the portion of the inner hub 40 positioned outside the shield 20 (that is, the operation portion 71 and the pair of fixing portions 73) is a conventional indwelling needle device 900.
  • 8 is substantially the same as the configuration (see FIG. 7) of the portion of the stopper 970 located outside the shield 920 (that is, the base portion 971 and the pair of fixing portions 973). Therefore, the puncturing operation can be performed with an operational feeling almost the same as that of puncturing a patient with the conventional indwelling needle device 900.
  • the inner hub main body 140, the operation part 71, the connecting part 72, and the pair of fixing parts 73 are integrated. Therefore, in order to perform the backward operation after the puncturing operation, for example, the operation unit 71 may be grasped and pulled backward. When the operation unit 71 is pulled, the inner hub main body 140 moves rearward integrally with the operation unit 71.
  • the indwelling needle device 100 of the present embodiment does not include an independent member corresponding to the stopper 970 (see FIG. 9) of the conventional indwelling needle device 900.
  • Members corresponding to the conventional stopper 970 are integrated with the inner hub body 140.
  • the operation unit 71 If the operation unit 71 is gripped and moved backward, the inner hub main body 140 always moves backward. Therefore, the possibility of erroneous operation that may occur in the conventional indwelling needle device 900 such as forgetting to move the inner unit 902 to the retracted position is reduced in this embodiment.
  • the inner unit 102 is moved to the retracted position by grasping the tube 60 instead of the operation unit 71 of the inner hub 40 and pulling it out from the outer unit 101. It is possible to make it.
  • the inner hub 40 can be easily separated by the notch 75 after the inner unit 102 is moved to the retracted position (see FIGS. 4 and 5). As shown in FIGS. 4 and 5, if the inner hub 40 protrudes far behind the rear end of the shield 20, an external force acts unintentionally on the protruding inner hub 40 and the outer needle 30. May cause troubles such as losing from the patient. By reducing the protrusion of the inner hub 40 out of the shield 20 as shown in FIG. 6 when the inner unit 102 is in the retracted position, the safety of subsequent operations can be improved.
  • a stopper 970 was provided as a separate member from the inner hub 940.
  • the indwelling needle apparatus 100 of this embodiment is not provided with the independent member called a stopper. Therefore, the number of parts constituting the indwelling needle device 100 is reduced, and thereby the number of assembly steps for the indwelling needle device 100 can be reduced. As a result, the cost of the indwelling needle device 100 can be reduced.
  • the conventional indwelling needle device 900 has a problem that the stopper falls off due to vibration during transfer.
  • the indwelling needle apparatus 100 of this embodiment is not provided with the independent member called a stopper.
  • the O-ring 49 attached to the inner hub 40 is in close contact with the inner peripheral surface of the shield cylinder 21, a certain amount of external force is required to move the inner unit 102 relative to the outer unit 101. Accordingly, after the indwelling needle device 100 is shipped with the inner unit 102 as the initial position, the inner unit 102 is displaced from the initial position to the retracted position due to vibration during transfer, and further, the inner hub 40 is shielded. The possibility of falling off 20 is low.
  • the posture of the inner hub 940 in the direction of rotation within the shield 920 (the direction of rotation around the central axis of the inner needle 950) is set. It was difficult to align accurately.
  • the notch 75 is formed at the boundary position between the inner hub main body 140 and the connecting portion 72.
  • the inner hub 40 is divided by the notch 75 in a state where the inner unit 102 is moved to the retracted position. If it can be done, the position of the notch 75 is not limited to this.
  • the notch 75 may be formed on the connecting portion 72.
  • the notch 75 having a reduced thickness is formed in order to facilitate the division of the inner hub 40, but the shape of the notch is not limited to this as long as the division can be facilitated.
  • the notch may locally reduce the width of the inner hub 40.
  • the inner hub 40 is divided by the notch 75, but the notch 75 may be omitted if the inner hub 40 can be divided.
  • the inner hub main body 140, the operation unit 71, the coupling unit 72, and the fixing unit 73 are simultaneously and integrally formed as one component by a method such as injection molding. can do.
  • the inner hub 40 of the present invention may be formed by joining two or more separately prepared parts to one part by a method such as adhesion.
  • the inner hub main body 140 and other parts that is, the operation unit 71, the coupling unit 72, and the fixing unit 73
  • a third component may be used for the joint portion.
  • the location of the inner hub 40 that is divided after the inner unit 102 is moved to the retracted position may be a joint location of separately created parts, or a location other than this.
  • the configurations of the outer unit 101 and the inner unit 102 can be arbitrarily changed within the scope of the present invention.
  • a large-area flat surface portion may be provided on the outer surface of the operation portion 71 so that the operation portion 71 can be easily grasped, and an uneven shape for preventing slipping may be formed.
  • the pair of fixing portions 73 may be omitted.
  • the connecting portion 72 may have any shape as long as the inner hub main body 140 and the operation portion 71 can be connected.
  • a thin rod shape may be used.
  • the fitting structure between the hub 40 and the shield 20 in the retracted position may have a configuration other than the above.
  • the fitting structure may be omitted.
  • the outer unit 101 shown in the above embodiment includes the shield cylinder 21, the outer hub 25, and the outer needle 30 which are separate parts. However, the shield cylinder 21 and the outer hub 25 are integrated into one part. The outer hub 25 and the outer needle 30 may be integrated into one part, and the shield tube 21, the outer hub 25, and the outer needle 30 may be integrated into one part. Also good. The wings 29a and 29b and the fixing member 28 that are attached to the outer unit 101 may be omitted.
  • the inner unit 102 is brought into the initial position with respect to the outer unit 101 by causing the front edge of the large-diameter portion 45 of the inner hub body 140 to collide with the rear edge of the outer hub 25. Positioned.
  • the position in the front-rear direction of the inner unit 102 at the initial position may be regulated by bringing the inner unit 102 and the outer unit 101 into contact at a place other than the above.
  • the indwelling needle device of the present invention is used for hemodialysis.
  • the use of the indwelling needle device of the present invention is not limited to this, and is used for any application in which an indwelling needle device such as infusion or blood transfusion is used. can do.
  • the field of application of the present invention is not particularly limited, and can be widely used as an indwelling needle device for performing treatments such as infusion, blood transfusion, and extracorporeal blood circulation. Especially, it can utilize preferably as an indwelling needle apparatus for hemodialysis.

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Abstract

An outer unit (101) is provided with a shield (20) having an inner cavity (24) and a soft outer needle (30) fixed to the front end of the shield. An inner unit (102) is provided with an inner hub (40) arranged having a portion inside the inner cavity of the shield, a hard inner needle (50) fixed to the front end of the inner hub, and a tube (60) connected to the inner hub. The inner unit displaces relative to the outer unit from an initial position where the inner needle passes through the outer needle and protrudes from the front end of the outer needle, to a retracted position where the inner needle is stored inside the inner cavity of the shield. The inner hub is provided with an operation unit (71) on the side opposite of the inner needle. When the inner unit is positioned in the initial position, the operation unit is positioned outside of the shield.

Description

留置針装置Indwelling needle device
　本発明は、軟質の外針と硬質の内針とを備え、外針の先端から内針の先端を突出させた状態で患者に穿刺し、その後、内針を外針から後退させることができるように構成された留置針装置に関する。 The present invention includes a soft outer needle and a hard inner needle, and can puncture a patient with the tip of the inner needle protruding from the tip of the outer needle, and then the inner needle can be retracted from the outer needle. It is related with the indwelling needle apparatus comprised as follows.
　留置針装置は、輸液、輸血、体外血液循環などの処置に広く使用される。このような処置において、金属針を血管内に留置すると血管が傷付けられる可能性がある。そこで、軟質の外針と硬質の内針とを備えた留置針装置が知られている。外針の先端から内針の先端を突出させた状態で外針及び内針を患者の血管に穿刺し、その後、内針を外針から後退させ、外針のみを患者に留置する。留置された軟質の外針は患者の血管を傷付ける可能性は低い。 Indwelling needle devices are widely used for treatments such as infusion, blood transfusion, and extracorporeal blood circulation. In such a procedure, if a metal needle is left in the blood vessel, the blood vessel may be damaged. Therefore, an indwelling needle device having a soft outer needle and a hard inner needle is known. With the tip of the inner needle protruding from the tip of the outer needle, the outer needle and the inner needle are punctured into the patient's blood vessel, and then the inner needle is retracted from the outer needle and only the outer needle is left in the patient. The indwelling soft outer needle is unlikely to damage the patient's blood vessels.
　図７は、このような従来の留置針装置９００（例えば特許文献１参照）の一例の上方から見た斜視図、図８は、図７の８－８線を含む垂直面に沿った従来の留置針装置９００の矢視断面図である。説明の便宜のため、患者に穿刺する側（図７、図８の紙面の左側）を「前側」、これと反対側を「後ろ側」と呼ぶ。 FIG. 7 is a perspective view of an example of such a conventional indwelling needle device 900 (see, for example, Patent Document 1) as viewed from above. FIG. 8 is a conventional view along a vertical plane including line 8-8 in FIG. It is arrow sectional drawing of the indwelling needle apparatus 900. FIG. For convenience of explanation, the side where the patient is punctured (the left side of the paper surface of FIGS. 7 and 8) is called the “front side”, and the opposite side is called the “rear side”.
　留置針装置９００は、略円筒形状を有するシールド筒９２１と、その一端（前端）に固定された外ハブ９２５とを含むシールド９２０を備える。外ハブ９２５の前端に軟質の外針９３０が固定されている。シールド筒９２１の外ハブ９２５側端近傍の外周面に一対の翼９２９ａ，９２９ｂが設けられている。翼９２９ａ，９２９ｂは柔軟性を有しており、上下に揺動可能である。 The indwelling needle device 900 includes a shield 920 including a shield cylinder 921 having a substantially cylindrical shape and an outer hub 925 fixed to one end (front end) thereof. A soft outer needle 930 is fixed to the front end of the outer hub 925. A pair of blades 929a and 929b are provided on the outer peripheral surface of the shield tube 921 near the outer hub 925 side end. The wings 929a and 929b have flexibility and can swing up and down.
　シールド９２０の内腔内には内ハブ９４０が挿入されている。内ハブ９４０の前端には金属製の硬質の内針９５０が固定され、内ハブ９４０の後端には柔軟なチューブ９６０の一端が接続されている。内針９５０とチューブ９６０とは、内ハブ９４０を前後方向に貫通する縦貫路９４３を介して連通している。 An inner hub 940 is inserted into the lumen of the shield 920. A metal hard inner needle 950 is fixed to the front end of the inner hub 940, and one end of a flexible tube 960 is connected to the rear end of the inner hub 940. The inner needle 950 and the tube 960 communicate with each other via a longitudinal passage 943 that penetrates the inner hub 940 in the front-rear direction.
　シールド筒９２１、外ハブ９２５、外針９３０、及び翼９２９ａ，９２９ｂは、留置針装置９００の外ユニット９０１を構成する。一方、内ハブ９４０、内針９５０、及びチューブ９６０は、留置針装置９００の内ユニット９０２を構成する。内ユニット９０２は、外ユニット９０１に対して、シールド９２０の長手方向（即ち、前後方向）に移動可能に挿入されている。 The shield tube 921, the outer hub 925, the outer needle 930, and the wings 929a and 929b constitute an outer unit 901 of the indwelling needle device 900. On the other hand, the inner hub 940, the inner needle 950, and the tube 960 constitute an inner unit 902 of the indwelling needle device 900. The inner unit 902 is inserted into the outer unit 901 so as to be movable in the longitudinal direction of the shield 920 (that is, the front-rear direction).
　図７、図８では、内ハブ９４０はシールド９２０の内腔の前端側に位置し、内ハブ９４０に保持された内針９５０は外針９３０を貫通し、内針９５０の先端は外針９３０の先端から外部に突出している。外ユニット９０１に対する内ユニット９０２のこの位置を「初期位置」と呼ぶ。 7 and 8, the inner hub 940 is located on the front end side of the lumen of the shield 920, the inner needle 950 held by the inner hub 940 passes through the outer needle 930, and the tip of the inner needle 950 is the outer needle 930. It protrudes from the tip of the outside. This position of the inner unit 902 relative to the outer unit 901 is referred to as an “initial position”.
　内ユニット９０２を初期位置に保持するために、ストッパー９７０が用いられる。図９はストッパー９７０の斜視図である。略半円筒形状の基部９７１から、略半円筒形状の挿入部９７２及び一対の固定部９７３が延びている。挿入部９７２は一対の固定部９７３の間に配置され、これらは互いに平行である。 A stopper 970 is used to hold the inner unit 902 in the initial position. FIG. 9 is a perspective view of the stopper 970. An approximately semi-cylindrical insertion portion 972 and a pair of fixing portions 973 extend from the substantially semi-cylindrical base portion 971. The insertion portion 972 is disposed between the pair of fixing portions 973 and these are parallel to each other.
　図８に示されているように、シールド筒９２１の後端から、ストッパー９７０の挿入部９７２を挿入する。挿入部９７２の先端を内ハブ９４０の後端に衝突させて内ハブ９４０を前側に押し込むことにより、内ユニット９０２を初期位置に配置することができる。 As shown in FIG. 8, the insertion portion 972 of the stopper 970 is inserted from the rear end of the shield tube 921. By causing the distal end of the insertion portion 972 to collide with the rear end of the inner hub 940 and pushing the inner hub 940 forward, the inner unit 902 can be disposed at the initial position.
　留置針装置９００は、以下のように使用される。 The indwelling needle device 900 is used as follows.
　最初に、内ユニット９０２を初期位置に保持したまま、内針９５０及び外針９３０を患者の血管に穿刺する（穿刺作業）。穿刺する際に内針９５０が患者から受ける反力によって、内針９５０が外針９３０内に収納されてしまうのを防止する必要がある。このため、穿刺作業は、ストッパー９７０を保持して行う必要がある。これにより、ストッパー９７０及び内ユニット９０２は外ユニット９０１に対して変位せず、内ユニット９０２は初期位置に維持される。 First, the inner needle 950 and the outer needle 930 are punctured into the patient's blood vessel while the inner unit 902 is held at the initial position (puncturing operation). It is necessary to prevent the inner needle 950 from being stored in the outer needle 930 due to the reaction force that the inner needle 950 receives from the patient during puncturing. For this reason, the puncturing operation needs to be performed while holding the stopper 970. Accordingly, the stopper 970 and the inner unit 902 are not displaced with respect to the outer unit 901, and the inner unit 902 is maintained at the initial position.
　内針９５０及び外針９３０を患者の血管に穿刺した後、シールド９２０からストッパー９７０を抜き去り、続いてシールド９２０からチューブ９６０を引き出す（後退作業）。チューブ９６０を引き出しながら同時にストッパー９７０をシールド９２０から抜き去ってもよい。チューブ９６０を引き出すことにより内ユニット９０２が外ユニット９０１に対して後方に移動し、図１０に示すように、内針９５０がシールド９２０内に収納される。図１０に示した外ユニット９０１に対する内ユニット９０２の位置を「後退位置」と呼ぶ。この状態で粘着テープ等を用いて留置針装置９００を患者に固定する。留置針装置９００は、軟質の外針９３０のみが患者に穿刺された状態で留置される。 After puncturing the patient's blood vessel with the inner needle 950 and the outer needle 930, the stopper 970 is removed from the shield 920, and then the tube 960 is withdrawn from the shield 920 (retraction operation). The stopper 970 may be removed from the shield 920 at the same time as the tube 960 is pulled out. By pulling out the tube 960, the inner unit 902 moves backward with respect to the outer unit 901, and the inner needle 950 is housed in the shield 920 as shown in FIG. The position of the inner unit 902 with respect to the outer unit 901 shown in FIG. In this state, the indwelling needle device 900 is fixed to the patient using an adhesive tape or the like. The indwelling needle device 900 is indwelled with only the soft outer needle 930 punctured by the patient.
特開２０１１－２５１０８１号公報JP 2011-251081 A
　従来の留置針装置９００では、ストッパー９７０は、内針９５０及び外針９３０を患者に穿刺する穿刺作業において、内ユニット９０２を初期位置に維持するためにのみ用いられる。ストッパー９７０は、その後の内ユニット９０２を後退位置に向かって移動させる後退作業に先立って又は後退作業とともにシールド９２０から抜き去られる。 In the conventional indwelling needle device 900, the stopper 970 is used only to maintain the inner unit 902 at the initial position in the puncturing operation for puncturing the patient with the inner needle 950 and the outer needle 930. The stopper 970 is removed from the shield 920 prior to or together with the backward operation for moving the inner unit 902 toward the backward position.
　ところが、ストッパー９７０のみをシールド９２０から抜き去ったことにより、内ユニット９０２を後退位置に移動させたと勘違いし、チューブ９６０を引っ張るのを忘れてしまうという誤操作をする危険がある。その結果、外針９３０の先端から内針９５０が突出した状態で留置針装置９００が患者に留置されるので、硬質の内針９５０の先端が患者の血管を傷付けてしまう可能性がある。 However, since only the stopper 970 is removed from the shield 920, there is a risk of misoperation that the user may forget to pull the tube 960 by misunderstanding that the inner unit 902 has been moved to the retracted position. As a result, since the indwelling needle device 900 is placed in the patient with the inner needle 950 protruding from the tip of the outer needle 930, the tip of the hard inner needle 950 may damage the patient's blood vessel.
　また、ストッパー９７０を備えることにより、留置針装置９００を構成する部品数が増大し、留置針装置９００のコストが増大する。 Further, by providing the stopper 970, the number of parts constituting the indwelling needle device 900 increases, and the cost of the indwelling needle device 900 increases.
　更に、シールド９２０内に挿入されたストッパー９７０が、留置針装置９００の移送中に振動などによりシールド９２０から抜け落ちる可能性がある。 Furthermore, the stopper 970 inserted into the shield 920 may fall out of the shield 920 due to vibration or the like during the transfer of the indwelling needle device 900.
　本発明は、上記の従来の留置針装置の問題を解決し、誤操作をする可能性が低減し、部品点数が少なく、更に移送中にストッパーが抜け落ちることがない留置針装置を提供することを目的とする。 An object of the present invention is to solve the problems of the above-described conventional indwelling needle device, to reduce the possibility of erroneous operation, to reduce the number of parts, and to provide an indwelling needle device in which a stopper does not fall out during transfer. And
　本発明の留置針装置は、内腔を有するシールド、及び、前記シールドの前端に固定された軟質の外針を含む外ユニットと、前記シールドの前記内腔内にその一部が配置された内ハブ、前記内ハブの前端に固定された硬質の内針、及び、前記内ハブに接続されたチューブを含む内ユニットとを備える。前記内針が前記外針を貫通して前記外針の先端から突出する初期位置から、前記内針が前記シールドの前記内腔内に収納される後退位置へ、前記内ユニットが前記外ユニットに対して変位する。前記内ハブは、前記内針とは反対側に操作部を備える。前記内ユニットを前記初期位置に配置したとき、前記操作部が前記シールド外に位置する。 An indwelling needle device according to the present invention includes a shield having a lumen, an outer unit including a soft outer needle fixed to the front end of the shield, and an inner portion partially disposed in the lumen of the shield. A hub, a hard inner needle fixed to the front end of the inner hub, and an inner unit including a tube connected to the inner hub. From the initial position where the inner needle penetrates the outer needle and protrudes from the tip of the outer needle to the retracted position where the inner needle is housed in the lumen of the shield, the inner unit moves to the outer unit. It is displaced with respect to it. The inner hub includes an operation portion on a side opposite to the inner needle. When the inner unit is arranged at the initial position, the operation unit is located outside the shield.
　本発明の留置針装置は、従来の留置針装置のストッパーに相当する独立した部材を備えない。シールド外に位置する操作部をシールドに対して後方に移動させれば、内ユニットを初期位置から後退位置に移動させることができる。従って、内ユニットを後退位置に移動させるのを忘れるという誤操作をする可能性が低減する。 The indwelling needle device of the present invention does not include an independent member corresponding to the stopper of the conventional indwelling needle device. If the operation unit located outside the shield is moved rearward with respect to the shield, the inner unit can be moved from the initial position to the retracted position. Therefore, the possibility of erroneous operation of forgetting to move the inner unit to the retracted position is reduced.
　本発明の留置針装置は従来の留置針装置のストッパーに相当する独立した部材を備えないから、留置針装置を構成する部品数が低減する。これは、留置針装置の低コスト化に有利である。 Since the indwelling needle device of the present invention does not include an independent member corresponding to the stopper of the conventional indwelling needle device, the number of parts constituting the indwelling needle device is reduced. This is advantageous for reducing the cost of the indwelling needle device.
　本発明の留置針装置は従来の留置針装置のストッパーに相当する独立した部材を備えないから、移送中に振動などによりストッパーがシールドから抜け落ちることはない。 Since the indwelling needle device of the present invention does not include an independent member corresponding to the stopper of the conventional indwelling needle device, the stopper does not fall off from the shield due to vibration during transfer.
図１は、内ユニットが初期位置にある、本発明の一実施形態にかかる留置針装置の上方から見た斜視図である。FIG. 1 is a perspective view seen from above of an indwelling needle device according to an embodiment of the present invention in which an inner unit is in an initial position. 図２は、図１の２－２線を含む垂直面に沿った、本発明の一実施形態にかかる留置針装置の矢視断面図である。FIG. 2 is a cross-sectional view of the indwelling needle device according to the embodiment of the present invention along the vertical plane including line 2-2 in FIG. 図３Ａは、本発明の一実施形態にかかる留置針装置に用いられる内ハブの斜視図である。FIG. 3A is a perspective view of an inner hub used in the indwelling needle device according to the embodiment of the present invention. 図３Ｂは図３Ａの３Ｂ－３Ｂ線を含む面に沿った、本発明の一実施形態にかかる留置針装置に用いられる内ハブの矢視断面図である。FIG. 3B is a cross-sectional view of the inner hub used in the indwelling needle device according to the embodiment of the present invention along the plane including the line 3B-3B in FIG. 3A. 図４は、内ユニットが後退位置にある、本発明の一実施形態にかかる留置針装置の上方から見た斜視図である。FIG. 4 is a perspective view seen from above the indwelling needle device according to the embodiment of the present invention in which the inner unit is in the retracted position. 図５は、図４の５－５線を含む垂直面に沿った、本発明の一実施形態にかかる留置針装置の矢視断面図である。FIG. 5 is a cross-sectional view of the indwelling needle device according to the embodiment of the present invention along the vertical plane including line 5-5 in FIG. 図６は、内ユニットが後退位置にあり、内ハブをノッチにて分断し、その後ろ側の部分が除去された、本発明の一実施形態にかかる留置針装置の上方から見た斜視図である。FIG. 6 is a perspective view seen from above of the indwelling needle device according to the embodiment of the present invention, in which the inner unit is in the retracted position, the inner hub is divided by a notch, and the rear side portion is removed. is there. 図７は、内ユニットが初期位置にある、従来の留置針装置の上方から見た斜視図である。FIG. 7 is a perspective view seen from above of a conventional indwelling needle device in which the inner unit is in the initial position. 図８は、図７の８－８線を含む垂直面に沿った従来の留置針装置の矢視断面図である。FIG. 8 is a cross-sectional view of the conventional indwelling needle device taken along the vertical plane including line 8-8 in FIG. 図９は、図７に示した従来の留置針装置に使用されるストッパーの斜視図である。FIG. 9 is a perspective view of a stopper used in the conventional indwelling needle device shown in FIG. 図１０は、内ユニットが後退位置にある、図７に示した従来の留置針装置の、図８と同じ面に沿った断面図である。10 is a cross-sectional view of the conventional indwelling needle device shown in FIG. 7 along the same plane as FIG. 8, with the inner unit in the retracted position.
　本発明の留置針装置は、内腔を有するシールド、及び、前記シールドの前端に固定された軟質の外針を含む外ユニットと、前記シールドの前記内腔内にその一部が配置された内ハブ、前記内ハブの前端に固定された硬質の内針、及び、前記内ハブに接続されたチューブを含む内ユニットとを備える。前記内針が前記外針を貫通して前記外針の先端から突出する初期位置から、前記内針が前記シールドの前記内腔内に収納される後退位置へ、前記内ユニットが前記外ユニットに対して変位する。前記内ハブは、前記内針とは反対側に操作部を備える。前記内ユニットを前記初期位置に配置したとき、前記操作部が前記シールド外に位置する。 An indwelling needle device according to the present invention includes a shield having a lumen, an outer unit including a soft outer needle fixed to the front end of the shield, and an inner portion partially disposed in the lumen of the shield. A hub, a hard inner needle fixed to the front end of the inner hub, and an inner unit including a tube connected to the inner hub. From the initial position where the inner needle penetrates the outer needle and protrudes from the tip of the outer needle to the retracted position where the inner needle is housed in the lumen of the shield, the inner unit moves to the outer unit. It is displaced with respect to it. The inner hub includes an operation portion on a side opposite to the inner needle. When the inner unit is arranged at the initial position, the operation unit is located outside the shield.
　上記の本発明の留置針装置において、前記内ユニットが前記後退位置に移動したとき、前記操作部を含む、前記内ハブのうち前記シールド外に位置する部分のうちの少なくとも一部を除去することができることが好ましい。これにより、内ハブのうちシールド外に位置する部分に意図しない外力が作用して外針が患者から抜けるというトラブルの発生を防止することができる。 In the indwelling needle device of the present invention described above, when the inner unit moves to the retracted position, at least a part of a portion of the inner hub located outside the shield is removed, including the operation portion. It is preferable that Thereby, it is possible to prevent a trouble that an unintended external force acts on a portion of the inner hub located outside the shield and the outer needle comes out of the patient.
　前記除去を容易にするためのノッチが前記内ハブに形成されていることが好ましい。これは、内ハブの分断を容易にするのに有利である。 It is preferable that a notch for facilitating the removal is formed in the inner hub. This is advantageous for facilitating the division of the inner hub.
　以下に、本発明を好適な実施形態を示しながら詳細に説明する。但し、本発明は以下の実施形態に限定されないことはいうまでもない。以下の説明において参照する各図は、説明の便宜上、本発明の実施形態の構成部材のうち、本発明を説明するために必要な主要部材のみを簡略化して示したものである。従って、本発明は以下の各図に示されていない任意の構成部材を備え得る。また、以下の各図中の部材の寸法は、実際の構成部材の寸法および各部材の寸法比率等を忠実に表したものではない。 Hereinafter, the present invention will be described in detail while showing preferred embodiments. However, it goes without saying that the present invention is not limited to the following embodiments. For convenience of explanation, the drawings referred to in the following description show only the main members necessary for explaining the present invention in a simplified manner among the constituent members of the embodiment of the present invention. Therefore, the present invention can include arbitrary components not shown in the following drawings. In addition, the dimensions of the members in the following drawings do not faithfully represent the actual dimensions of the constituent members and the dimensional ratios of the members.
　図１は、内ユニットが初期位置にある、本発明の一実施形態にかかる留置針装置１００の上方から見た斜視図である。以下の説明の便宜のため、留置針装置１００の長手方向をＺ軸、Ｚ軸と直交する水平方向軸及び上下方向軸をそれぞれＸ軸及びＹ軸とする直交座標系を設定する。Ｙ軸の矢印の側（即ち、図１の紙面の上側）を「上側」、これと反対側を「下側」と呼ぶ。但し、「水平方向」及び「上下方向」は、留置針装置１００の実際の使用時の向きを意味するものではない。更に、患者に穿刺する側（Ｚ軸の矢印の側、即ち、図１の紙面の左側）を「前側」、これと反対側を「後ろ側」と呼ぶ。図２は、図１の２－２線を含む垂直面（ＹＺ面）に沿った留置針装置１００の矢視断面図である。 FIG. 1 is a perspective view seen from above of an indwelling needle device 100 according to an embodiment of the present invention in which an inner unit is in an initial position. For convenience of the following description, an orthogonal coordinate system is set in which the longitudinal direction of the indwelling needle device 100 is the Z axis, the horizontal axis orthogonal to the Z axis, and the vertical axis are the X axis and Y axis, respectively. The Y-axis arrow side (that is, the upper side in FIG. 1) is called “upper side”, and the opposite side is called “lower side”. However, the “horizontal direction” and the “vertical direction” do not mean the directions when the indwelling needle device 100 is actually used. Further, the side where the patient is punctured (the side of the arrow on the Z axis, that is, the left side of FIG. 1) is called the “front side”, and the opposite side is called the “rear side”. 2 is a cross-sectional view of the indwelling needle device 100 taken along the vertical plane (YZ plane) including the line 2-2 in FIG.
　留置針装置１００は、シールド２０を備える。シールド２０は、シールド筒２１と、シールド筒２１の一端（前端）に固定された外ハブ２５とを有する。シールド筒２１は、内径が一定の略円筒形状を有する。シールド筒２１の外ハブ２５とは反対側端（後端）近傍の内周面には、周方向に連続する係止突起２２が形成されている。外ハブ２５は略漏斗形状を有し、そのシールド筒２１とは反対側端（前端）に軟質の外針３０が固定されている。外針３０は略円筒形状を有する。シールド筒２１及び外ハブ２５の材料としては、特に制限はないが、硬質材料が好ましく、例えば、ポリカーボネート、ポリプロピレン等を用いることができる。シールド筒２１及び外ハブ２５が透明又は透光性を有すると、シールド２０の内腔２４内の液体（薬液又は血液など）や内ハブ４０を透視することができるので好ましい。外針３０の材料としては、特に制限はないが、軟質材料が好ましく、例えば、ポリプロピレン、ポリウレタン系エラストマー、ポリテトラフルオロエチレン等のフッ素樹脂等を用いることができる。外針３０が透明又は透光性を有すると、その内腔内の液体（薬液又は血液など）や内針５０を透視することができるので好ましい。なお、外ハブ２５及び外針３０を、上記の軟質材料を用いて一体に形成してもよい。 The indwelling needle device 100 includes a shield 20. The shield 20 includes a shield cylinder 21 and an outer hub 25 fixed to one end (front end) of the shield cylinder 21. The shield cylinder 21 has a substantially cylindrical shape with a constant inner diameter. A locking protrusion 22 that is continuous in the circumferential direction is formed on the inner peripheral surface of the shield tube 21 in the vicinity of the end (rear end) opposite to the outer hub 25. The outer hub 25 has a substantially funnel shape, and a soft outer needle 30 is fixed to an end (front end) opposite to the shield tube 21. The outer needle 30 has a substantially cylindrical shape. The material of the shield tube 21 and the outer hub 25 is not particularly limited, but is preferably a hard material. For example, polycarbonate, polypropylene, or the like can be used. It is preferable that the shield cylinder 21 and the outer hub 25 be transparent or translucent because the liquid (chemical liquid or blood) in the inner cavity 24 of the shield 20 or the inner hub 40 can be seen through. The material of the outer needle 30 is not particularly limited, but a soft material is preferable. For example, a fluorine resin such as polypropylene, polyurethane elastomer, polytetrafluoroethylene, or the like can be used. It is preferable that the outer needle 30 is transparent or translucent because the liquid (chemical liquid or blood) in the lumen and the inner needle 50 can be seen through. The outer hub 25 and the outer needle 30 may be integrally formed using the soft material described above.
　参照符号２９ａ，２９ｂは、Ｘ軸と略平行に延びた翼である。翼２９ａ，２９ｂは、略円筒形状の固定部材２８に設けられている。固定部材２８をシールド筒２１の外ハブ２５側端近傍の外周面に外装することにより、翼２９ａ，２９ｂがシールド２０に装着されている。翼２９ａ，２９ｂの材料としては、特に制限はないが、軟質材料が好ましく、例えば、ポリプロピレン、塩化ビニル、ポリエチレン、オレフィン系又はポリスチレン系の熱可塑性エラストマー等を用いることができる。なお、翼２９ａ，２９ｂは、シールド２０に一体に成形されていてもよい。 Reference numerals 29a and 29b are wings extending substantially parallel to the X axis. The wings 29 a and 29 b are provided on a substantially cylindrical fixing member 28. By attaching the fixing member 28 to the outer peripheral surface of the shield cylinder 21 near the end on the outer hub 25 side, the wings 29 a and 29 b are attached to the shield 20. The material of the blades 29a and 29b is not particularly limited, but a soft material is preferable. For example, polypropylene, vinyl chloride, polyethylene, olefin-based or polystyrene-based thermoplastic elastomers, and the like can be used. The wings 29a and 29b may be formed integrally with the shield 20.
　シールド２０の内腔２４内には内ハブ４０が、シールド２０の長手方向（即ち、Ｚ軸方向）に移動可能に挿入されている。 An inner hub 40 is inserted into the inner cavity 24 of the shield 20 so as to be movable in the longitudinal direction of the shield 20 (that is, the Z-axis direction).
　図３Ａは内ハブ４０の斜視図、図３Ｂは図３Ａの３Ｂ－３Ｂ線を含む垂直面（ＹＺ面）に沿った内ハブ４０の矢視断面図である。本実施形態の内ハブ４０は、従来の留置針装置９００の内ハブ９４０（図８参照）とストッパー９７０（図９参照）とを一体化させたのと近似した形状を有している。内ハブ４０のうち、従来の内ハブ９４０に相当する部分を内ハブ本体１４０と呼ぶ。 3A is a perspective view of the inner hub 40, and FIG. 3B is a cross-sectional view of the inner hub 40 along the vertical plane (YZ plane) including the line 3B-3B in FIG. 3A. The inner hub 40 of the present embodiment has a shape that approximates that the inner hub 940 (see FIG. 8) and the stopper 970 (see FIG. 9) of the conventional indwelling needle device 900 are integrated. A portion of the inner hub 40 corresponding to the conventional inner hub 940 is referred to as an inner hub body 140.
　内ハブ本体１４０は、一端（前端）に、円錐面状の外面を有する前部４１を有し、他端に円筒面状の外面を有する後部４２を有する。縦貫路４３が、内ハブ本体１４０の中心軸１４０ａに沿って前部４１から後部４２まで内ハブ本体１４０を縦貫している。 The inner hub main body 140 has a front portion 41 having a conical outer surface at one end (front end) and a rear portion 42 having a cylindrical outer surface at the other end. A longitudinal passage 43 passes through the inner hub main body 140 from the front portion 41 to the rear portion 42 along the central axis 140 a of the inner hub main body 140.
　前部４１と後部４２との間の、内ハブ本体１４０の外周面に、周方向に連続する環状溝４４が形成されている。 An annular groove 44 continuous in the circumferential direction is formed on the outer peripheral surface of the inner hub main body 140 between the front portion 41 and the rear portion 42.
　内ハブ本体１４０の外周面に、環状溝４４と前部４１との間に、環状溝４４側から径大部４５及び径小部４６がこの順に形成されている。径小部４６は前部４１に隣接し、径小部４６の外径は、前部４１の最大径とほぼ同じであり、且つ、径大部４５の外径よりも小さい。前部４１、径小部４６、及び径大部４５には、これらを直径方向（内ハブ本体１４０の中心軸１４０ａに直交する方向）に横貫する横貫路４７が形成されている。横貫路４７は、縦貫路４３と交差し且つ連通している。 On the outer peripheral surface of the inner hub main body 140, a large diameter portion 45 and a small diameter portion 46 are formed in this order between the annular groove 44 and the front portion 41 from the annular groove 44 side. The small diameter portion 46 is adjacent to the front portion 41, and the outer diameter of the small diameter portion 46 is substantially the same as the maximum diameter of the front portion 41 and is smaller than the outer diameter of the large diameter portion 45. The front portion 41, the small diameter portion 46, and the large diameter portion 45 are formed with a transverse passage 47 that passes through them in the diameter direction (a direction orthogonal to the central axis 140 a of the inner hub main body 140). The transverse passage 47 intersects and communicates with the longitudinal passage 43.
　後部４２の周囲に、４つの弾性片４８が、中心軸１４０ａに対して等角度間隔で配置されている。弾性片４８は、中心軸１４０ａに対して略平行に延びている。弾性片４８の後部４２とは反対側の面には、嵌合溝４８ａとテーパ面４８ｂとが形成されている。嵌合溝４８ａは、内ハブ本体１４０の周方向に沿った凹部（溝）である。テーパ面４８ｂは、嵌合溝４８ａに対して弾性片４８の自由端側に隣接し、嵌合溝４８ａ側で外径が大きな円錐面の一部をなす。 Around the rear part 42, four elastic pieces 48 are arranged at equiangular intervals with respect to the central axis 140a. The elastic piece 48 extends substantially parallel to the central axis 140a. A fitting groove 48 a and a tapered surface 48 b are formed on the surface opposite to the rear portion 42 of the elastic piece 48. The fitting groove 48 a is a recess (groove) along the circumferential direction of the inner hub main body 140. The tapered surface 48b is adjacent to the fitting groove 48a on the free end side of the elastic piece 48, and forms a part of a conical surface having a large outer diameter on the fitting groove 48a side.
　４つの弾性片４８のうちの３つは片持ち支持され、残りの１つの先端には、連結部７２を介して操作部７１が接続されている。連結部７２は、短冊状の薄板である。弾性片４８と連結部７２との間の境界には、局所的に薄肉化したノッチ７５が形成されている。連結部７２を挟むように、一対の固定部７３が操作部７１から内ハブ本体１４０の側に延びている。固定部７３は、短冊状の薄板であり、連結部７２に接離する方向に容易に弾性変形可能である。 Three of the four elastic pieces 48 are cantilevered, and the operation part 71 is connected to the remaining one end via a connecting part 72. The connection part 72 is a strip-shaped thin plate. A notch 75 that is locally thinned is formed at the boundary between the elastic piece 48 and the connecting portion 72. A pair of fixing portions 73 extend from the operation portion 71 toward the inner hub main body 140 so as to sandwich the connecting portion 72. The fixing portion 73 is a strip-shaped thin plate, and can be easily elastically deformed in a direction in which the fixing portion 73 comes in contact with or separates from the connecting portion 72.
　内ハブ４０の材料としては、特に制限はないが、硬質材料が好ましく、例えば、ポリカーボネート、ポリプロピレン、ポリエチレン等を用いることができる。 Although there is no restriction | limiting in particular as a material of the inner hub 40, A hard material is preferable, For example, a polycarbonate, a polypropylene, polyethylene etc. can be used.
　図２に示されているように、内針５０が、内ハブ本体１４０の前部４１側から縦貫路４３内に挿入されて、内ハブ４０に保持される。後部４２が柔軟なチューブ６０内に挿入されて、内ハブ４０とチューブ６０とが接続される。かくして、内針５０とチューブ６０とは、内ハブ本体１４０の縦貫路４３を通じて連通される。チューブ６０の内ハブ本体１４０とは反対側端は、例えば輸液を行うための点滴回路に接続されている。 2, the inner needle 50 is inserted into the longitudinal passage 43 from the front portion 41 side of the inner hub main body 140 and is held by the inner hub 40. The rear portion 42 is inserted into the flexible tube 60 and the inner hub 40 and the tube 60 are connected. Thus, the inner needle 50 and the tube 60 are communicated through the longitudinal passage 43 of the inner hub body 140. The end opposite to the inner hub body 140 of the tube 60 is connected to, for example, an infusion circuit for performing infusion.
　内針５０は、金属製の硬質材料からなる。内針５０は略円筒形状を有し、その先端は鋭利に加工されている。チューブ６０の材料としては、特に制限はないが、軟質材料が好ましく、例えば、塩化ビニル等の樹脂材料を用いることができる。 The inner needle 50 is made of a metal hard material. The inner needle 50 has a substantially cylindrical shape, and the tip is processed sharply. The material of the tube 60 is not particularly limited, but is preferably a soft material. For example, a resin material such as vinyl chloride can be used.
　内ハブ本体１４０の環状溝（図３Ａ、図３Ｂ参照）にＯリング４９が装着されている。Ｏリング４９はシールド筒２１の内周面に密着し、シールド２０の内腔２４において、Ｏリング４９よりも外針３０側の薬液又は血液がＯリング４９よりもチューブ６０側に漏洩するのを防ぐ。Ｏリング４９の材料としては、特に制限はないが、柔軟性を有し弾性的変形可能な材料が好ましく、例えば、ポリイソプレンゴム、シリコーンゴム、熱可塑性エラストマー等を用いることができる。 The O-ring 49 is attached to the annular groove (see FIGS. 3A and 3B) of the inner hub main body 140. The O-ring 49 is in close contact with the inner peripheral surface of the shield cylinder 21, and in the inner cavity 24 of the shield 20, the drug solution or blood on the outer needle 30 side of the O-ring 49 leaks to the tube 60 side of the O-ring 49. prevent. The material of the O-ring 49 is not particularly limited, but is preferably a flexible material that can be elastically deformed. For example, polyisoprene rubber, silicone rubber, thermoplastic elastomer, or the like can be used.
　シールド２０と、シールド２０に固定された外針３０、翼２９ａ，２９ｂ、及び固定部材２８は留置針装置１００の外ユニット１０１を構成する。一方、内ハブ４０、内針５０、及びチューブ６０は、留置針装置１００の内ユニット１０２を構成する。内ユニット１０２は、外ユニット１０１に対して、シールド２０の長手方向（即ち、前後方向）に移動可能に挿入されている。 The shield 20, the outer needle 30 fixed to the shield 20, the wings 29 a and 29 b, and the fixing member 28 constitute an outer unit 101 of the indwelling needle device 100. On the other hand, the inner hub 40, the inner needle 50, and the tube 60 constitute an inner unit 102 of the indwelling needle device 100. The inner unit 102 is inserted into the outer unit 101 so as to be movable in the longitudinal direction of the shield 20 (that is, the front-rear direction).
　図１、図２では、内ハブ本体１４０はシールド２０の内腔２４の前端側に位置し、内ハブ４０に保持された内針５０は外針３０を貫通し、その先端は外針３０の先端から外部に突出している。操作部７１は、シールド２０の後端よりも後ろ側に位置し、外界に露出している。一対の固定部７３は、シールド２０を挟むように、シールド２０外に配置されている。外ユニット１０１に対する内ユニット１０２のこの位置を本発明では「初期位置」と呼ぶ。 In FIG. 1 and FIG. 2, the inner hub main body 140 is located on the front end side of the inner cavity 24 of the shield 20, the inner needle 50 held by the inner hub 40 penetrates the outer needle 30, and the tip thereof is the outer needle 30. Projects outward from the tip. The operation unit 71 is located behind the rear end of the shield 20 and is exposed to the outside. A pair of fixing | fixed part 73 is arrange | positioned outside the shield 20 so that the shield 20 may be pinched | interposed. This position of the inner unit 102 with respect to the outer unit 101 is referred to as an “initial position” in the present invention.
　図４は、内ユニット１０２が後退位置にある留置針装置１００の上方から見た斜視図である。図５は、図４の５－５線を含む垂直面（ＹＺ面）に沿った留置針装置１００の矢視断面図である。 FIG. 4 is a perspective view seen from above the indwelling needle device 100 in which the inner unit 102 is in the retracted position. FIG. 5 is a cross-sectional view of the indwelling needle device 100 along the vertical plane (YZ plane) including the line 5-5 in FIG.
　図５に示されているように、内ユニット１０２が「後退位置」にあるとき、内ハブ４０の嵌合溝４８ａ（図３Ａ、図３Ｂを参照）とシールド筒２１の係止突起２２とが嵌合している。また、内ハブ４０に保持された内針５０は外針３０から抜き去られ、シールド２０の内腔２４内に収納されている。 As shown in FIG. 5, when the inner unit 102 is in the “retracted position”, the fitting groove 48 a (see FIGS. 3A and 3B) of the inner hub 40 and the locking protrusion 22 of the shield tube 21 are It is mated. Further, the inner needle 50 held by the inner hub 40 is removed from the outer needle 30 and stored in the inner cavity 24 of the shield 20.
　初期位置（図１、図２参照）に比べると、後退位置では、外針３０内の流路の断面積は内針５０の断面積分だけ増大するので、薬液又は血液の流量が増大する。また、後退位置では、外針３０からチューブ６０に至る流路としては、内針５０の内腔及び内ハブ本体１４０の縦貫路４３を順に通る第１流路と、シールド２０の内面と内針５０及び内ハブ本体１４０の各外面との間の空間、内ハブ本体１４０の横貫路４７、及び内ハブ本体１４０の縦貫路４３を順に通る第２流路の２つがあるので、大きな流量で薬液又は血液を流すことができる。 Compared with the initial position (see FIGS. 1 and 2), in the retracted position, the cross-sectional area of the flow path in the outer needle 30 increases by the cross-sectional integral of the inner needle 50, so the flow rate of the drug solution or blood increases. In the retracted position, the flow path from the outer needle 30 to the tube 60 includes a first flow path that sequentially passes through the lumen of the inner needle 50 and the longitudinal passage 43 of the inner hub body 140, the inner surface of the shield 20, and the inner needle. 50 and the outer surface of the inner hub main body 140, the transverse passage 47 of the inner hub main body 140, and the second flow path passing through the longitudinal passage 43 of the inner hub main body 140 in this order. Or blood can be shed.
　以上のように、本実施形態の留置針装置１００では、内ユニット１０２は、図１及び図２に示す初期位置から図４及び図５に示す後退位置に、外ユニット１０１に対して前後方向に移動することができる。 As described above, in the indwelling needle device 100 of the present embodiment, the inner unit 102 moves from the initial position shown in FIGS. 1 and 2 to the retracted position shown in FIGS. Can move.
　以上のように構成された本実施形態の留置針装置１００の使用方法及び作用を説明する。 The usage method and operation of the indwelling needle device 100 of the present embodiment configured as described above will be described.
　本実施形態の留置針装置１００は、内ユニット１０２が初期位置（図１、図２）に配置された状態で病院などの医療機関に納入される。内ハブ本体１４０の径大部４５（図３Ａ、図３Ｂ参照）の前側の端縁を、外ハブ２５の後ろ側の端縁に衝突させることにより、内ユニット１０２は初期位置に位置決めされる。 The indwelling needle device 100 of the present embodiment is delivered to a medical institution such as a hospital in a state where the inner unit 102 is disposed at the initial position (FIGS. 1 and 2). By causing the front edge of the large diameter portion 45 (see FIGS. 3A and 3B) of the inner hub main body 140 to collide with the rear edge of the outer hub 25, the inner unit 102 is positioned at the initial position.
　医療機関では、作業者は、図１及び図２に示すように、内ユニット１０２が初期位置にあり且つ内針５０が外針３０の先端から突出した状態で、内針５０及び外針３０を患者の血管に穿刺する（穿刺作業）。このとき、内針５０は、穿刺する向きとは逆向きの反力を受ける。この反力は、内ユニット１０２を外ユニット１０１に対して後退位置の側に移動させるように作用する。内ユニット１０２が外ユニット１０１に対して後退位置の側に移動しないように、内ハブ４０のうちシールド２０外に位置する部分、即ち、操作部７１又は一対の固定部７３を保持しながら留置針装置１００を穿刺する。 In the medical institution, as shown in FIGS. 1 and 2, the operator moves the inner needle 50 and the outer needle 30 with the inner unit 102 in the initial position and the inner needle 50 protruding from the tip of the outer needle 30. The patient's blood vessel is punctured (puncture operation). At this time, the inner needle 50 receives a reaction force opposite to the puncturing direction. This reaction force acts to move the inner unit 102 toward the retracted position with respect to the outer unit 101. An indwelling needle is held while holding a portion of the inner hub 40 located outside the shield 20, that is, the operation portion 71 or the pair of fixing portions 73 so that the inner unit 102 does not move toward the retracted position with respect to the outer unit 101. The device 100 is punctured.
　次に、外針３０を患者に穿刺した状態で、内ユニット１０２を後退させる（後退作業）。例えば、外ユニット１０１が患者に対して変位しないように一方の手（例えば穿刺作業で留置針装置１００を把持していたのとは異なる手）で外ユニット１０１を保持しながら、他方の手で内ハブ４０の操作部７１を把持して外ユニット１０１から内ユニット１０２を引き出せばよい。操作部７１とともに内ユニット１０２は後方に移動する。 Next, with the outer needle 30 punctured into the patient, the inner unit 102 is retracted (retracting operation). For example, while holding the outer unit 101 with one hand (for example, a hand different from the one holding the indwelling needle device 100 by a puncturing operation) so that the outer unit 101 is not displaced with respect to the patient, The operation unit 71 of the inner hub 40 may be held and the inner unit 102 may be pulled out from the outer unit 101. The inner unit 102 moves rearward together with the operation unit 71.
　シールド筒２１の後端近傍の内周面には係止突起２２が形成されている。内ハブ本体１４０が係止突起２２まで移動し、内ハブ本体１４０の弾性片４８の外面に形成されたテーパ面４８ｂ（図３Ａ、図３Ｂを参照）が係止突起２２上を摺動する。このとき弾性片４８は後部４２側に弾性変形する。次いで、テーパ面４８ｂが係止突起２２を乗り越えると、弾性片４８が弾性回復し、嵌合溝４８ａに係止突起２２が嵌入する。かくして、内ユニット１０２は図４及び図５に示した後退位置に移動する。 A locking projection 22 is formed on the inner peripheral surface near the rear end of the shield tube 21. The inner hub main body 140 moves to the locking protrusion 22, and a tapered surface 48 b (see FIGS. 3A and 3B) formed on the outer surface of the elastic piece 48 of the inner hub main body 140 slides on the locking protrusion 22. At this time, the elastic piece 48 is elastically deformed toward the rear portion 42 side. Next, when the taper surface 48b gets over the locking protrusion 22, the elastic piece 48 is elastically recovered, and the locking protrusion 22 is fitted into the fitting groove 48a. Thus, the inner unit 102 moves to the retracted position shown in FIGS.
　図５に示されているように、弾性片４８と連結部７２との間のノッチ７５が、シールド２０の後端よりも後ろ側に位置している。シールド２０が患者から離れないようにシールド２０の上面を押さえながら、矢印Ａの向きに操作部７１を上方に持ち上げる。薄肉化されたことにより機械的強度が相対的に弱いノッチ７５において内ハブ４０が折れ曲がり、内ハブ４０はノッチ７５にて破断する。内ハブ４０のうち、ノッチ７５より前側の部分（即ち、内ハブ本体１４０）はシールド２０内に残留し、ノッチ７５より後ろ側の部分（即ち、操作部７１、連結部７２、及び固定部７３）が除去される。図６は、内ハブ４０をノッチ７５にて分割し、内ハブ４０のノッチ７５より後ろ側の部分を除去した留置針装置１００の斜視図である。 As shown in FIG. 5, the notch 75 between the elastic piece 48 and the connecting portion 72 is located behind the rear end of the shield 20. The operation unit 71 is lifted upward in the direction of arrow A while pressing the upper surface of the shield 20 so that the shield 20 does not leave the patient. Due to the thinning, the inner hub 40 bends at the notch 75 having relatively weak mechanical strength, and the inner hub 40 is broken at the notch 75. Of the inner hub 40, a portion on the front side of the notch 75 (that is, the inner hub main body 140) remains in the shield 20, and a portion on the rear side of the notch 75 (that is, the operation portion 71, the coupling portion 72, and the fixing portion 73). ) Is removed. FIG. 6 is a perspective view of the indwelling needle device 100 in which the inner hub 40 is divided by a notch 75 and a portion behind the notch 75 of the inner hub 40 is removed.
　この状態で外ユニット１０１の上から粘着テープを患者の皮膚に貼り付け、留置針装置１００を患者に固定する。外針３０のみが患者に穿刺された状態で留置される。内ユニット１０２が後退位置にあるとき、柔軟な外針３０内に硬質の内針５０が存在しないので、患者が動くなどにより、患者に対する留置針装置１００の姿勢が仮に変化しても、外針３０が患者の血管等を傷付けることはない。 In this state, an adhesive tape is applied to the patient's skin from above the outer unit 101, and the indwelling needle device 100 is fixed to the patient. Only the outer needle 30 is indwelled while being punctured by the patient. When the inner unit 102 is in the retracted position, the hard inner needle 50 does not exist in the flexible outer needle 30, so that even if the posture of the indwelling needle device 100 with respect to the patient changes temporarily due to movement of the patient, the outer needle 30 does not damage the patient's blood vessels or the like.
　必要な処置が終了すると、外ユニット１０１を固定する粘着テープを患者から剥がし、外針３０を患者から引き抜く。外ユニット１０１に対してチューブ６０を押し引きしても、内ハブ本体１４０の嵌合溝４８ａとシールド筒２１の係止突起２２との嵌合状態は解除されない。即ち、内針５０を外針３０の先端から再度突出させたり、内ユニット１０２を外ユニット１０１から引き出したりすることはできない。従って、硬質の内針５０を誤って穿刺したり、使用済みの留置針装置１００を誤って再使用したりするのを防止している。使用済みの留置針装置１００は廃棄される。 When necessary treatment is completed, the adhesive tape for fixing the outer unit 101 is peeled off from the patient, and the outer needle 30 is pulled out from the patient. Even if the tube 60 is pushed and pulled with respect to the outer unit 101, the fitting state between the fitting groove 48a of the inner hub main body 140 and the locking projection 22 of the shield tube 21 is not released. That is, the inner needle 50 cannot protrude again from the tip of the outer needle 30, and the inner unit 102 cannot be pulled out from the outer unit 101. Accordingly, it is possible to prevent the hard inner needle 50 from being punctured by mistake and the used indwelling needle device 100 from being reused by mistake. The used indwelling needle device 100 is discarded.
　以上のように本実施形態では、穿刺作業時に、内ハブ４０のうちシールド２０外に位置する部分（例えば、操作部７１、一対の固定部７３）を保持しながら留置針装置１００を穿刺することができる。従って、穿刺作業において内針５０が反力を受けても、内ユニット１０２は、後退位置に向かって移動することはなく初期位置のままである。 As described above, in the present embodiment, at the time of puncturing, the indwelling needle device 100 is punctured while holding the portion of the inner hub 40 located outside the shield 20 (for example, the operation unit 71 and the pair of fixing units 73). Can do. Therefore, even if the inner needle 50 receives a reaction force in the puncturing operation, the inner unit 102 does not move toward the retracted position and remains at the initial position.
　内ユニット１０２が初期位置にあるとき、内ハブ４０のうちシールド２０外に位置する部分（即ち、操作部７１及び一対の固定部７３）の形態（図１参照）は、従来の留置針装置９００において、ストッパー９７０のうちシールド９２０外に位置する部分（即ち、基部９７１及び一対の固定部９７３）の形態（図７参照）と実質的に同じである。従って、従来の留置針装置９００を患者に穿刺するのとほとんど変わらない操作感で穿刺作業を行うことができる。 When the inner unit 102 is in the initial position, the configuration (see FIG. 1) of the portion of the inner hub 40 positioned outside the shield 20 (that is, the operation portion 71 and the pair of fixing portions 73) is a conventional indwelling needle device 900. 8 is substantially the same as the configuration (see FIG. 7) of the portion of the stopper 970 located outside the shield 920 (that is, the base portion 971 and the pair of fixing portions 973). Therefore, the puncturing operation can be performed with an operational feeling almost the same as that of puncturing a patient with the conventional indwelling needle device 900.
　本実施形態の内ハブ４０では、内ハブ本体１４０と、操作部７１、連結部７２及び一対の固定部７３とが一体化されている。従って、穿刺作業の後、後退作業を行うためには、例えば操作部７１を把持して後方に向かって引っ張ればよい。操作部７１を引っ張れば、内ハブ本体１４０は、操作部７１と一体的に後方に向かって移動する。 In the inner hub 40 of the present embodiment, the inner hub main body 140, the operation part 71, the connecting part 72, and the pair of fixing parts 73 are integrated. Therefore, in order to perform the backward operation after the puncturing operation, for example, the operation unit 71 may be grasped and pulled backward. When the operation unit 71 is pulled, the inner hub main body 140 moves rearward integrally with the operation unit 71.
　上述したように、従来の留置針装置９００では、内ハブ９４０（図８参照）とストッパー９７０（図９参照）とは別部材であった。従って、ストッパー９７０をシールド９２０から抜き去ったことにより、内ユニット９０２が後退位置に移動したと勘違いするという誤操作をする危険があった。これに対して、本実施形態の留置針装置１００は、従来の留置針装置９００のストッパー９７０（図９参照）に相当する独立した部材を備えない。内ハブ本体１４０に従来のストッパー９７０に相当する部材（操作部７１、連結部７２及び一対の固定部７３）が一体化されている。操作部７１を把持して後方に移動させれば内ハブ本体１４０は必ず後方に移動する。従って、内ユニット９０２を後退位置に移動させるのを忘れるという従来の留置針装置９００で発生しうる誤操作をする可能性が、本実施形態では低減される。 As described above, in the conventional indwelling needle device 900, the inner hub 940 (see FIG. 8) and the stopper 970 (see FIG. 9) were separate members. Accordingly, there is a risk of erroneous operation that the internal unit 902 may be mistaken for moving to the retracted position by removing the stopper 970 from the shield 920. In contrast, the indwelling needle device 100 of the present embodiment does not include an independent member corresponding to the stopper 970 (see FIG. 9) of the conventional indwelling needle device 900. Members corresponding to the conventional stopper 970 (the operating portion 71, the connecting portion 72, and the pair of fixing portions 73) are integrated with the inner hub body 140. If the operation unit 71 is gripped and moved backward, the inner hub main body 140 always moves backward. Therefore, the possibility of erroneous operation that may occur in the conventional indwelling needle device 900 such as forgetting to move the inner unit 902 to the retracted position is reduced in this embodiment.
　なお、本実施形態においても、従来の留置針装置９００と同様に、内ハブ４０の操作部７１ではなく、チューブ６０を把持して外ユニット１０１から引き出すことにより、内ユニット１０２を後退位置に移動させることが可能である。 Also in this embodiment, as in the case of the conventional indwelling needle device 900, the inner unit 102 is moved to the retracted position by grasping the tube 60 instead of the operation unit 71 of the inner hub 40 and pulling it out from the outer unit 101. It is possible to make it.
　内ハブ４０にノッチ７５が形成されているので、内ユニット１０２を後退位置（図４、図５参照）に移動させた後、ノッチ７５にて内ハブ４０を容易に分断することができる。図４及び図５に示すように、シールド２０の後端よりも後方に内ハブ４０が大きく突出したままでは、この突出した内ハブ４０の部分に意図せずに外力が作用して外針３０が患者から抜けてしまうなどのトラブルが生じる可能性がある。内ユニット１０２が後退位置にあるときに図６に示すように内ハブ４０のシールド２０外への突出を少なくすることにより、その後の作業の安全を向上させることができる。 Since the notch 75 is formed in the inner hub 40, the inner hub 40 can be easily separated by the notch 75 after the inner unit 102 is moved to the retracted position (see FIGS. 4 and 5). As shown in FIGS. 4 and 5, if the inner hub 40 protrudes far behind the rear end of the shield 20, an external force acts unintentionally on the protruding inner hub 40 and the outer needle 30. May cause troubles such as losing from the patient. By reducing the protrusion of the inner hub 40 out of the shield 20 as shown in FIG. 6 when the inner unit 102 is in the retracted position, the safety of subsequent operations can be improved.
　従来の留置針装置９００では、内ハブ９４０とは別部材としてストッパー９７０を備えていた。これに対して、本実施形態の留置針装置１００は、ストッパーという独立した部材を備えていない。従って、留置針装置１００を構成する部品数が低減し、これにより留置針装置１００の組み立て工数を少なくすることができる。この結果、留置針装置１００の低コスト化が可能である。 In the conventional indwelling needle device 900, a stopper 970 was provided as a separate member from the inner hub 940. On the other hand, the indwelling needle apparatus 100 of this embodiment is not provided with the independent member called a stopper. Therefore, the number of parts constituting the indwelling needle device 100 is reduced, and thereby the number of assembly steps for the indwelling needle device 100 can be reduced. As a result, the cost of the indwelling needle device 100 can be reduced.
　従来の留置針装置９００では、移送中に振動などによりストッパーが抜け落ちるという問題があった。これに対して、本実施形態の留置針装置１００は、ストッパーという独立した部材を備えていない。また、内ハブ４０に装着したＯリング４９がシールド筒２１の内周面に密着しているので、外ユニット１０１に対して内ユニット１０２を移動させるためには、ある程度の外力が必要である。従って、留置針装置１００が内ユニット１０２を初期位置にして出荷された後に、移送中の振動などにより内ユニット１０２が初期位置から後退位置の側に位置ずれしたり、更には内ハブ４０がシールド２０から抜け落ちたりする可能性は低い。 The conventional indwelling needle device 900 has a problem that the stopper falls off due to vibration during transfer. On the other hand, the indwelling needle apparatus 100 of this embodiment is not provided with the independent member called a stopper. Further, since the O-ring 49 attached to the inner hub 40 is in close contact with the inner peripheral surface of the shield cylinder 21, a certain amount of external force is required to move the inner unit 102 relative to the outer unit 101. Accordingly, after the indwelling needle device 100 is shipped with the inner unit 102 as the initial position, the inner unit 102 is displaced from the initial position to the retracted position due to vibration during transfer, and further, the inner hub 40 is shielded. The possibility of falling off 20 is low.
　従来の留置針装置９００では、内ハブ９４０とストッパー９７０とが別部材であったので、シールド９２０内での内ハブ９４０の回転方向（内針９５０の中心軸回りに回転する方向）の姿勢を正確に位置合わせすることが困難であった。これに対して、本実施形態では、シールド２０外に位置する操作部７１を用いて内ハブ本体１４０の回転方向（中心軸１４０ａ回りに回転する方向）の姿勢を容易に調整することができる。 In the conventional indwelling needle device 900, since the inner hub 940 and the stopper 970 are separate members, the posture of the inner hub 940 in the direction of rotation within the shield 920 (the direction of rotation around the central axis of the inner needle 950) is set. It was difficult to align accurately. On the other hand, in this embodiment, it is possible to easily adjust the posture of the inner hub main body 140 in the rotation direction (direction rotating around the central axis 140a) using the operation unit 71 located outside the shield 20.
　上記の実施形態は例示に過ぎない。本発明は上記の実施形態に限定されず、適宜変更することができる。 The above embodiment is merely an example. The present invention is not limited to the above embodiment, and can be modified as appropriate.
　上記の実施形態では、ノッチ７５は内ハブ本体１４０と連結部７２との境界位置に形成されていたが、内ユニット１０２を後退位置に移動させた状態で、ノッチ７５にて内ハブ４０を分断することができれば、ノッチ７５の位置はこれに限定されない。例えば、ノッチ７５が連結部７２上に形成されていてもよい。 In the above embodiment, the notch 75 is formed at the boundary position between the inner hub main body 140 and the connecting portion 72. However, the inner hub 40 is divided by the notch 75 in a state where the inner unit 102 is moved to the retracted position. If it can be done, the position of the notch 75 is not limited to this. For example, the notch 75 may be formed on the connecting portion 72.
　上記の実施形態では、内ハブ４０の分断を容易にするために、厚みを薄くしたノッチ７５を形成したが、分断を容易にすることができればノッチの形状はこれに限定されない。例えば、ノッチが、内ハブ４０の幅を局所的に狭くするものであってもよい。 In the above embodiment, the notch 75 having a reduced thickness is formed in order to facilitate the division of the inner hub 40, but the shape of the notch is not limited to this as long as the division can be facilitated. For example, the notch may locally reduce the width of the inner hub 40.
　上記の実施形態では、ノッチ７５にて内ハブ４０を分断したが、内ハブ４０を分断することができるのであればノッチ７５を省略してもよい。 In the above embodiment, the inner hub 40 is divided by the notch 75, but the notch 75 may be omitted if the inner hub 40 can be divided.
　上記の実施形態の内ハブ４０（図３Ａ、図３Ｂ参照）は、内ハブ本体１４０、操作部７１、連結部７２、固定部７３を例えば射出成形等の方法により同時に一体的に１部品として作成することができる。但し、例えば別個に作成した２以上の部品を接着などの方法で１部品に接合して、本発明の内ハブ４０を作成してもよい。例えば、内ハブ本体１４０とこれ以外の部分（即ち、操作部７１、連結部７２、固定部７３）とを、それぞれ別々に作成し、これら２部品を接着等の方法で接合してもよい。このとき、必要であれば、接合部分に第３部品を用いてもよい。内ハブ４０をどの位置で２以上の部品に分割して別個に作成するかは任意に設定することができる。内ユニット１０２を後退位置に移動させた後に分断される内ハブ４０の箇所は、別個に作成した部品の接合箇所であってもよいし、これ以外の箇所であってもよい。 In the inner hub 40 (see FIGS. 3A and 3B) of the above-described embodiment, the inner hub main body 140, the operation unit 71, the coupling unit 72, and the fixing unit 73 are simultaneously and integrally formed as one component by a method such as injection molding. can do. However, for example, the inner hub 40 of the present invention may be formed by joining two or more separately prepared parts to one part by a method such as adhesion. For example, the inner hub main body 140 and other parts (that is, the operation unit 71, the coupling unit 72, and the fixing unit 73) may be separately created, and these two parts may be joined by a method such as adhesion. At this time, if necessary, a third component may be used for the joint portion. It is possible to arbitrarily set at which position the inner hub 40 is divided into two or more parts and created separately. The location of the inner hub 40 that is divided after the inner unit 102 is moved to the retracted position may be a joint location of separately created parts, or a location other than this.
　上記の実施形態では内ユニット１０２を後退位置に移動させた後に、内ハブ４０のうちシールド２０外に位置する部分の少なくとも一部を除去したが、この除去を行わなくてもよい。即ち、内ユニット１０２を後退位置に移動させた後、内ハブ４０の一部がシールド２０の外に突出したまま（図４、図５参照）にしておいてもよい。 In the above embodiment, after the inner unit 102 is moved to the retracted position, at least a part of the inner hub 40 located outside the shield 20 is removed. However, this removal may not be performed. That is, after the inner unit 102 is moved to the retracted position, a part of the inner hub 40 may be left protruding from the shield 20 (see FIGS. 4 and 5).
　外ユニット１０１及び内ユニット１０２の構成は、本発明の範囲内において任意に変更することができる。 The configurations of the outer unit 101 and the inner unit 102 can be arbitrarily changed within the scope of the present invention.
　例えば、操作部７１の外面に、操作部７１を把持しやすいように大面積の平面部を設けてもよく、また、滑りを防止するための凹凸形状を形成してもよい。 For example, a large-area flat surface portion may be provided on the outer surface of the operation portion 71 so that the operation portion 71 can be easily grasped, and an uneven shape for preventing slipping may be formed.
　一対の固定部７３を省略してもよい。 The pair of fixing portions 73 may be omitted.
　連結部７２は、内ハブ本体１４０と操作部７１とを連結することができれば、その形状は任意である。例えば、細い棒状であってもよい。 The connecting portion 72 may have any shape as long as the inner hub main body 140 and the operation portion 71 can be connected. For example, a thin rod shape may be used.
　後退位置にあるハブ４０とシールド２０との嵌合構造は、上記以外の構成を有していてもよい。あるいは、当該嵌合構造を省略してもよい。 The fitting structure between the hub 40 and the shield 20 in the retracted position may have a configuration other than the above. Alternatively, the fitting structure may be omitted.
　上記の実施形態に示した外ユニット１０１は、互いに別部品であるシールド筒２１、外ハブ２５、及び外針３０を備えていたが、シールド筒２１と外ハブ２５とを一体化して一部品で構成してもよく、外ハブ２５と外針３０とを一体化して一部品で構成してもよく、更にシールド筒２１、外ハブ２５、及び外針３０を一体化して一部品で構成してもよい。外ユニット１０１に装着されていた翼２９ａ，２９ｂ及び固定部材２８を省略してもよい。 The outer unit 101 shown in the above embodiment includes the shield cylinder 21, the outer hub 25, and the outer needle 30 which are separate parts. However, the shield cylinder 21 and the outer hub 25 are integrated into one part. The outer hub 25 and the outer needle 30 may be integrated into one part, and the shield tube 21, the outer hub 25, and the outer needle 30 may be integrated into one part. Also good. The wings 29a and 29b and the fixing member 28 that are attached to the outer unit 101 may be omitted.
　上記の実施形態では、内ハブ本体１４０の径大部４５の前側の端縁を、外ハブ２５の後ろ側の端縁に衝突させることで、内ユニット１０２を外ユニット１０１に対して初期位置に位置決めした。しかしながら、内ユニット１０２及び外ユニット１０１を、上記以外の箇所で当接させることにより、初期位置の内ユニット１０２の前後方向位置を規制してもよい。 In the above embodiment, the inner unit 102 is brought into the initial position with respect to the outer unit 101 by causing the front edge of the large-diameter portion 45 of the inner hub body 140 to collide with the rear edge of the outer hub 25. Positioned. However, the position in the front-rear direction of the inner unit 102 at the initial position may be regulated by bringing the inner unit 102 and the outer unit 101 into contact at a place other than the above.
　上記の説明では本発明の留置針装置を血液透析に用いたが、本発明の留置針装置の用途はこれに限定されず、輸液や輸血等の留置針装置が使用される任意の用途に利用することができる。 In the above description, the indwelling needle device of the present invention is used for hemodialysis. However, the use of the indwelling needle device of the present invention is not limited to this, and is used for any application in which an indwelling needle device such as infusion or blood transfusion is used. can do.
　本発明の利用分野は特に制限はなく、輸液、輸血、体外血液循環などの処置を行う際の留置針装置として広範囲に利用することができる。中でも、血液透析用の留置針装置として好ましく利用することができる。 The field of application of the present invention is not particularly limited, and can be widely used as an indwelling needle device for performing treatments such as infusion, blood transfusion, and extracorporeal blood circulation. Especially, it can utilize preferably as an indwelling needle apparatus for hemodialysis.
１００　留置針装置
１０１　外ユニット
１０２　内ユニット
２０　シールド
２１　シールド筒
２４　シールドの内腔
２５　外ハブ
３０　外針
４０　内ハブ
４９　Ｏリング
５０　内針
６０　チューブ
７１　操作部
７２　連結部
７５　ノッチ
１４０　内ハブ本体 DESCRIPTION OF SYMBOLS 100 Indwelling needle apparatus 101 Outer unit 102 Inner unit 20 Shield 21 Shield cylinder 24 Shield lumen 25 Outer hub 30 Outer needle 40 Inner hub 49 O-ring 50 Inner needle 60 Tube 71 Operation part 72 Connection part 75 Notch 140 Inner hub body

Claims (3)

  1. 　内腔を有するシールド、及び、前記シールドの前端に固定された軟質の外針を含む外ユニットと、
    　前記シールドの前記内腔内にその一部が配置された内ハブ、前記内ハブの前端に固定された硬質の内針、及び、前記内ハブに接続されたチューブを含む内ユニットとを備え、
    　前記内針が前記外針を貫通して前記外針の先端から突出する初期位置から、前記内針が前記シールドの前記内腔内に収納される後退位置へ、前記内ユニットが前記外ユニットに対して変位する留置針装置であって、
    　前記内ハブは、前記内針とは反対側に操作部を備え、
    　前記内ユニットを前記初期位置に配置したとき、前記操作部は前記シールド外に位置することを特徴とする留置針装置。     An outer unit including a shield having a lumen, and a soft outer needle fixed to the front end of the shield;
    An inner hub having a part thereof disposed in the lumen of the shield, a hard inner needle fixed to a front end of the inner hub, and an inner unit including a tube connected to the inner hub,
    From the initial position where the inner needle penetrates the outer needle and protrudes from the tip of the outer needle to the retracted position where the inner needle is housed in the lumen of the shield, the inner unit moves to the outer unit. An indwelling needle device which is displaced relative to
    The inner hub includes an operation portion on the opposite side to the inner needle,
    The indwelling needle device according to claim 1, wherein when the inner unit is arranged at the initial position, the operation unit is located outside the shield.
  2. 　前記内ユニットが前記後退位置に移動したとき、前記操作部を含む、前記内ハブのうち前記シールド外に位置する部分のうちの少なくとも一部を除去することができる請求項１に記載の留置針装置。 2. The indwelling needle according to claim 1, wherein when the inner unit moves to the retracted position, at least a part of a portion of the inner hub located outside the shield including the operation portion can be removed. apparatus.
  3. 　前記除去を容易にするためのノッチが前記内ハブに形成されている請求項２に記載の留置針装置。 The indwelling needle device according to claim 2, wherein a notch for facilitating the removal is formed in the inner hub.
PCT/JP2013/065082 2012-05-31 2013-05-30 Indwelling needle device WO2013180234A1 (en)

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JP2012-125047 2012-05-31

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WO2018191361A1 (en) 2017-04-13 2018-10-18 Teleflex Medical Incorporated Catheter insertion device

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JPS56125058A (en) * 1979-11-29 1981-10-01 Abbott Lab Improved vein needling device
JP2009254576A (en) * 2008-04-16 2009-11-05 Jms Co Ltd Indwelling needle device
JP4506834B2 (en) * 2006-01-20 2010-07-21 株式会社ジェイ・エム・エス Medical needle device
JP2011251081A (en) * 2010-06-04 2011-12-15 Jms Co Ltd Indwelling needle device

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JP4586974B2 (en) * 2005-02-28 2010-11-24 株式会社ジェイ・エム・エス Indwelling needle structure
JP4586975B2 (en) * 2005-02-28 2010-11-24 株式会社ジェイ・エム・エス Indwelling needle structure
JP5637350B2 (en) * 2009-12-14 2014-12-10 株式会社ジェイ・エム・エス Needle device
JP2013022069A (en) * 2011-07-15 2013-02-04 Jms Co Ltd Indwelling needle device

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Publication number Priority date Publication date Assignee Title
JPS56125058A (en) * 1979-11-29 1981-10-01 Abbott Lab Improved vein needling device
JP4506834B2 (en) * 2006-01-20 2010-07-21 株式会社ジェイ・エム・エス Medical needle device
JP2009254576A (en) * 2008-04-16 2009-11-05 Jms Co Ltd Indwelling needle device
JP2011251081A (en) * 2010-06-04 2011-12-15 Jms Co Ltd Indwelling needle device

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018191361A1 (en) 2017-04-13 2018-10-18 Teleflex Medical Incorporated Catheter insertion device
EP3609565A4 (en) * 2017-04-13 2021-01-13 Teleflex Medical Incorporated Catheter insertion device

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