Catheter assembly

Abstract

To provide a catheter assembly capable of preventing occurrence of erroneous puncture after extracting an inner needle from an outer needle hub.SOLUTION: In a catheter assembly 10, when an operation member 26 turns from a first position to a second position along a circumferential direction, a pressing part presses an actuation button 90 to move the actuation button 90 from an initial position to an actuation position. When the operation member 26 turns from the first position to the second position along the circumferential direction, a locking state of a locking part 106 and an outer needle hub 16 is cancelled.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to a catheter assembly. [Background technology]

[0002] The catheter assembly comprises a catheter (outer needle) with an open tip, a catheter hub (outer needle hub) connected to the base end of the catheter, and an inner needle that is inserted into the lumen of the catheter and can be inserted into a living body.

[0003] Patent Document 1 discloses a needle protection device capable of protecting a needle tip, such as the tip of an inner needle in a catheter assembly. The needle protection device includes a needle guard slidably attached to the inner needle, a spring that biases the needle guard toward the tip of the inner needle, and a button that restricts movement of the needle guard toward the tip. When a user presses the button, the engagement between the button and the needle guard is released, and the needle guard moves toward the tip due to the elastic force of the spring. The needle guard covers the tip of the inner needle, preventing it from being exposed to the outside. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2001-502191 Summary of the Invention [Problem to be solved by the invention]

[0005] The needle protection device in Patent Document 1 is configured so that the user can press a button to move the needle guard toward the distal end. Therefore, if the user forgets to press the button when removing the inner needle from the living body, for example, the needle guard will not move toward the distal end, leaving the tip of the inner needle exposed, which could result in an accidental needle stick.

[0006] The present invention aims to solve the above-mentioned problems. [Means for solving the problem]

[0007] (1) An aspect of the present invention comprises a tubular outer needle, an outer needle hub connected to the base end of the outer needle, an inner needle inserted into the lumen of the outer needle and protruding from the tip of the outer needle in the tip direction, an inner needle hub provided at the base end of the inner needle and connected to the base end of the outer needle hub, a needle protection structure that covers at least the tip of the inner needle by utilizing the elastic force of a biasing member, and an operating member that is rotatably supported on the inner needle hub and rotates in the circumferential direction around the axis of the inner needle to activate the needle protection structure. the needle protection structure comprises the biasing member, a housing section that is movable relative to the inner needle in the axial direction of the inner needle and that is capable of covering at least the tip of the inner needle, and an actuation button that is provided so as to be movable between an initial position and an actuation position, and when the actuation button is located at the initial position, the relative movement between the inner needle and the housing section is restricted against the elastic force of the biasing member, and when the actuation button is moved from the initial position to the actuation position, the relative movement between the inner needle and the housing section is restricted the housing portion covers at least the tip of the inner needle by utilizing the resilient force of the biasing member; the operating member has a manipulation body portion rotatably supported on the outer peripheral surface of the inner needle hub, a pressing portion connected to the manipulation body portion and capable of pressing the activation button, and a locking portion connected to the manipulation body portion and connectable to the base end of the outer needle hub; when the operating member is located at a first position in the circumferential direction, the pressing portion is in a non-contact state with the activation button, so that the activation button is located at the initial position, and the outer needle hub is restrained by the locking portion so as to be immovable in the axial direction, so that the outer needle hub is fixed to the locking portion; and when the operating member rotates from the first position to a second position in the circumferential direction, the pressing portion presses the activation button to move the activation button from the initial position to the activated position, and the fixed state between the locking portion and the outer needle hub is released.

[0008] According to this configuration, when the user rotates the operating member around the axis of the inner needle (circumferential direction) from the first position to the second position, the pressing portion presses the activation button, thereby activating the needle protection structure and covering at least the tip of the inner needle with the housing portion. Furthermore, by rotating the operating member circumferentially from the first position to the second position, the fixed state between the locking portion and the outer needle hub is released. In this way, the action of covering at least the tip of the inner needle and the action of releasing the fixed state between the locking portion and the outer needle hub are carried out simultaneously in conjunction with the rotation of the operating member. As a result, the tip of the inner needle is always covered by the needle protection structure, making it possible to prevent accidental punctures from occurring after the inner needle is removed from the outer needle hub.

[0009] (2) In the catheter assembly described in (1) above, the activation button is provided on the inner needle hub, the operating main body portion is a tubular member rotatably arranged on the outer peripheral surface of the inner needle hub so as to cover the activation button, the pressing portion is a pressing convex portion protruding from the inner peripheral surface of the operating main body portion in a radial direction of the inner needle perpendicular to the axial direction, and when the operating member rotates from the first position to the second position along the circumferential direction, the pressing convex portion may press the activation button radially inward.

[0010] According to this configuration, the operating body covers the activation button provided on the inner needle hub, so the user does not directly press the activation button. This prevents accidental operation of the activation button. Furthermore, when the operating member rotates from the first position to the second position, the pressing convex portion formed on the inner circumferential surface of the operating body can effectively press the activation button. In this way, the activation button is pressed simultaneously with the withdrawal of the inner needle member from the outer needle member, so the needle tip of the inner needle can be effectively protected during the user's procedure.

[0011] (3) In the catheter assembly described in (2) above, the tip of the operating main body portion contacts the outer peripheral surface of the inner needle hub, and a flange protruding in the radial direction is formed on the outer peripheral surface of the inner needle hub, and the flange may be located on the outer peripheral surface of the inner needle hub in the proximal direction relative to the tip of the operating main body portion.

[0012] According to this configuration, when the manipulation main body part is displaced in the proximal direction, the distal end part of the manipulation main body part abuts against the flange of the inner needle hub, thereby effectively preventing the manipulation member from separating from the inner needle hub in the proximal direction.

[0013] (4) In the catheter assembly described in any one of (1) to (3) above, the locking portion is a tubular member located distally of the operating body portion and the pressing portion, and rotatably arranged on the outer peripheral surface of the inner needle hub, a protrusion is provided on the base end of the outer needle hub, and a female thread portion that screws onto the protrusion is provided on the inner peripheral surface of the locking portion, and when the operating member is located at the first position, the protrusion screws onto the female thread portion, thereby fixing the outer needle hub to the locking portion, and when the operating member is rotated from the first position to the second position, the screwed state between the protrusion and the female thread portion is released, thereby releasing the fixed state between the locking portion and the outer needle hub.

[0014] According to this configuration, the outer needle hub can be effectively fixed to the locking portion when the operating member is located at the first position, and the fixed state between the outer needle hub and the locking portion can be effectively released when the operating member is rotated from the first position to the second position.

[0015] (5) In the catheter assembly described in any one of (1) to (4) above, the outer needle hub may have an outer needle engaging portion provided on the outer needle hub, and the inner needle hub may have an inner needle engaging portion provided on the inner needle hub, and when the inner needle hub is connected to the base end of the outer needle hub, the inner needle engaging portion and the outer needle engaging portion may engage with each other, thereby preventing the inner needle hub from rotating in the circumferential direction in association with the rotation of the operating member in the circumferential direction.

[0016] According to this configuration, when the operating member is rotated in the circumferential direction, the inner needle hub can be prevented from rotating together with the operating member.

[0017] (6) In the catheter assembly described in (5) above, the outer needle engaging portion may be a mating recess or mating protrusion formed at the base end of the outer needle hub, and the inner needle engaging portion may be a mating protrusion or mating recess formed on the inner needle hub, and the mating recess and the mating protrusion may be mated when the inner needle hub is connected to the base end of the outer needle hub.

[0018] According to this configuration, when the operating member is rotated in the circumferential direction, the inner needle hub can be effectively prevented from rotating together with the operating member. Furthermore, the fitting recess or fitting convex portion is formed on the proximal end of the outer needle hub. This allows the fitting recess and fitting convex portion to be fitted together when the inner needle hub is connected to the proximal end of the outer needle hub while ensuring sealing between the inner needle hub and the outer needle hub.

[0019] (7) The catheter assembly according to any one of (1) to (6) above may further comprise a slip-out prevention portion provided on the inner needle hub to prevent the operating member from coming off the inner needle hub.

[0020] According to this configuration, the operating member is prevented from coming off the inner needle hub, so that the pressing action of the pressing portion on the operating button and the action of releasing the fixed state between the locking portion and the outer needle hub can be performed effectively.

[0021] (8) In the catheter assembly described in (7) above, the locking portion is a tubular member located further distally than the operating body portion and the pressing portion and rotatably arranged on the outer peripheral surface of the inner needle hub, the anti-slip portion is a rib protruding from the outer peripheral surface of the inner needle hub in the radial direction of the inner needle perpendicular to the axial direction, and the base end of the locking portion is located further proximally than the rib and may contact the outer peripheral surface of the inner needle hub.

[0022] According to this configuration, when the locking portion is displaced in the distal direction, the proximal end of the locking portion abuts against the rib, thereby effectively preventing the operating member from separating from the inner needle hub in the distal direction. [Effects of the Invention]

[0023] According to the present invention, when the user rotates the operating member around the axis of the inner needle (circumferential direction) from the first position to the second position, the pressing portion presses the activation button, thereby activating the needle protection structure and covering at least the tip of the inner needle with the housing portion. Furthermore, by rotating the operating member circumferentially from the first position to the second position, the fixed state between the locking portion and the outer needle hub is released. In this way, the action of covering at least the tip of the inner needle and the action of releasing the fixed state between the locking portion and the outer needle hub are carried out simultaneously in conjunction with the rotation of the operating member. As a result, the tip of the inner needle is always covered by the needle protection structure, making it possible to prevent accidental punctures from occurring after the inner needle is removed from the outer needle hub. [Brief explanation of the drawings]

[0024] [Figure 1] FIG. 1 is a cross-sectional view of a catheter assembly. [Figure 2] 2A is a cross-sectional view taken along line IIA-IIA in FIG. 1, and FIG. 2B is a partial cross-sectional view taken along line IIB-IIB in FIG. [Figure 3] FIG. 3 is an explanatory diagram showing the catheter assembly in a puncturing state. [Figure 4] FIG. 4 is a cross-sectional view of the catheter assembly. [Figure 5] FIG. 5 is a partial cross-sectional view taken along line VV in FIG. [Figure 6] FIG. 6A is a partial cross-sectional view showing another configuration of the catheter assembly, and FIG. 6B is a cross-sectional view taken along line VIB-VIB in FIG. 6A. DETAILED DESCRIPTION OF THE INVENTION

[0025] 1 is a cross-sectional view of a catheter assembly 10 according to this embodiment. When at least the tip of the catheter assembly 10 is inserted into a living body 12 (see FIG. 3) such as a patient, a part of the catheter assembly 10 is placed within the living body 12.

[0026] The catheter assembly 10 comprises an outer needle 14, an outer needle hub 16, an inner needle 18, an inner needle hub 20, a needle holder 22, a needle protection structure 24, and an operating member 26. The outer needle 14 and the outer needle hub 16 constitute an outer needle member 28. The inner needle 18, the inner needle hub 20, and the needle holder 22 constitute an inner needle member 30.

[0027] The outer needle member 28 and the inner needle member 30 are connected in sequence along the central axis (axis 32) of the catheter assembly 10. The outer needle member 28 and the inner needle member 30 are arranged coaxially with the axis 32. In the following description, the direction along the axis 32 will be referred to as the axial direction. The direction along the axis 32 toward the outer needle member 28 will be referred to as the distal direction. The direction along the axis 32 away from the outer needle member 28 (the direction toward the inner needle member 30) will be referred to as the proximal direction. The direction perpendicular to the axis 32 will be referred to as the radial direction. The direction around the axis 32 will be referred to as the circumferential direction.

[0028] The outer needle member 28 is a catheter. The outer needle 14 is a catheter body. The outer needle 14 is a tubular member extending in the axial direction. The outer needle 14 has an inner lumen 34 formed in the axial direction. The outer needle 14 is flexible. The material that constitutes the outer needle 14 is, for example, a resin material. The tip of the outer needle 14 is tapered toward the tip. The tip of the outer needle 14 is open toward the tip. The tip of the outer needle 14 is the end that is inserted into the living body 12.

[0029] The outer needle hub 16 is a catheter hub. The outer needle hub 16 is a tubular member extending in the axial direction. The outer needle hub 16 has a hub lumen 36 formed in the axial direction. The outer needle hub 16 is desirably made of a material that is harder than the outer needle 14. The material that makes up the outer needle hub 16 is, for example, a resin material.

[0030] The outer needle hub 16 has an outer needle hub body 38, a hub distal end portion 40, and a hub proximal end portion 42. The outer needle hub body 38 is the main body portion of the outer needle hub 16. The outer needle hub body 38 is a tubular member. The outer needle hub body 38 is formed in a tapered shape that tapers toward the distal end. It is desirable that the inner circumferential surface 44 of the outer needle hub body 38 be a luer taper.

[0031] The hub distal end 40 is provided at the distal end of the outer needle hub body 38. The hub proximal end 42 is provided at the proximal end of the outer needle hub body 38. The hub lumen 36 extends axially from the hub distal end 40 to the hub proximal end 42. The distal end of the hub lumen 36 communicates with the lumen 34 of the outer needle 14.

[0032] As shown in FIGS. 1 and 2A , the hub base end 42 has a pair of lock fittings 46. The pair of lock fittings 46 are protrusions 48 that protrude radially outward from the hub base end 42. The pair of lock fittings 46 face each other across the axis 32. That is, the pair of lock fittings 46 are provided on the hub base end 42 at 180° intervals in the circumferential direction. The inner needle hub 20 of the inner needle member 30 is inserted into the hub lumen 36 of the outer needle hub 16 from the proximal end opening of the outer needle hub 16. When the inner needle member 30 is removed from the outer needle member 28 in the proximal direction, a supply tool for supplying a drug solution, such as a syringe or drug solution tube, can be connected to the hub base end 42. At this time, if the supply tool is provided with a lock fitting, the lock fitting 46 and the lock fitting provided on the supply tool are fitted together, thereby fixing the supply tool to the lock fitting 46. Instead of the pair of lock fitting portions 46, the hub base end portion 42 may have a threaded fitting portion that runs around the entire circumference.

[0033] As shown in FIG. 1, the inner needle 18 is a tubular member having sufficient rigidity to puncture the skin 50 (see FIG. 3) of a living body 12. The inner needle 18 is inserted through the lumen 34 of the outer needle 14 and the hub lumen 36 of the outer needle hub 16. The overall length of the inner needle 18 is sufficiently longer than the outer needle 14 and the outer needle hub 16. Therefore, the tip of the inner needle 18 protrudes in the distal direction from the tip of the outer needle 14. The base end of the inner needle 18 protrudes in the proximal direction from the base end of the outer needle hub 16. As shown in FIG. 2A, the inner needle 18 has a lumen 52 extending along the axis 32 (see FIG. 1). As shown in FIG. 1, the tip of the inner needle 18 opens toward the distal direction. The base end of the inner needle 18 communicates with the outside of the inner needle 18. The inner needle 18 is made of a metal material such as stainless steel.

[0034] The inner needle hub 20 is a tubular member extending in the axial direction. The inner needle hub 20 has a hub lumen 54 formed in the axial direction. The inner needle hub 20 may be made of the same material as the outer needle hub 16. The material constituting the inner needle hub 20 is, for example, a resin material.

[0035] The inner needle hub 20 has an inner needle hub body 56 and a hub tip portion 58. The inner needle hub body 56 is the main body portion of the inner needle hub 20. The inner needle hub body 56 is a tubular member extending in the axial direction. The hub tip portion 58 is provided at the tip of the inner needle hub body 56.

[0036] The base end side of the inner needle hub body 56 is housed inside the housing 60. The housing 60 is a tubular member extending along the axis 32. The base end side of the inner needle hub body 56 is housed in the housing 60, whereby the inner needle hub body 56 is held in the housing 60. The tip side of the inner needle hub body 56 protrudes from the housing 60 in the tip direction. The tip side of the inner needle hub body 56 forms a protruding part 62 that protrudes from the housing 60.

[0037] The protruding portion 62 is provided with a pair of insertion holes 64. The pair of insertion holes 64 are provided on the proximal end side of the protruding portion 62. The pair of insertion holes 64 penetrate the peripheral wall of the inner needle hub 20 in the radial direction. The pair of insertion holes 64 face each other across the axis 32. In other words, the pair of insertion holes 64 are provided in the peripheral wall of the inner needle hub 20 at 180° intervals in the circumferential direction.

[0038] The protruding portion 62 is provided with a pair of flanges 66, 68. The pair of flanges 66, 68 are provided on the protruding portion 62 with a gap between them in the axial direction. The pair of flanges 66, 68 are annular flanges that protrude radially from an outer circumferential surface 70 of the inner needle hub 20. More specifically, the pair of flanges 66, 68 protrude radially from the outer circumferential surface of the protruding portion 62, which is part of the outer circumferential surface 70 of the inner needle hub 20. One flange 66 (flange) is formed on the outer circumferential surface of the protruding portion 62 closer to the distal end than the pair of insertion holes 64. The other flange 68 is formed on the outer circumferential surface of the protruding portion 62 closer to the proximal end than the pair of insertion holes 64.

[0039] A slip-out prevention portion 72 is provided on the outer peripheral surface 70 of the inner needle hub 20. More specifically, the slip-out prevention portion 72 is provided on the outer peripheral surface of the protruding portion 62 of the outer peripheral surface 70 of the inner needle hub 20. The slip-out prevention portion 72 is a rib 74 that protrudes radially from the outer peripheral surface of the protruding portion 62. The rib 74 is, for example, an annular rib. The rib 74 is formed on the distal side of the pair of flanges 66, 68.

[0040] A cap 76 is attached to each base end of the housing 60 and the inner needle hub body 56. The cap 76 closes each base end of the housing 60 and the inner needle hub body 56. The cap 76 is provided with an air vent filter 77. The air vent filter 77 allows air to pass between the hub lumen 54 and the outside of the catheter assembly 10, while preventing the passage of liquids such as blood.

[0041] The hub tip portion 58 of the inner needle hub 20 extends distally from the inner needle hub main body 56. The hub tip portion 58 is formed in a tapered shape that narrows as it extends distally. The hub tip portion 58 is desirably a luer taper. The inner needle hub 20 and the outer needle hub 16 are connected by inserting the hub tip portion 58 distally into the hub base end portion 42 of the outer needle hub 16.

[0042] A stepped portion 80 is provided on the inner circumferential surface 78 of the inner needle hub 20 at the boundary between the inner needle hub main body 56 and the hub tip portion 58. The stepped portion 80 is an annular protruding portion that protrudes radially inward from the inner circumferential surface 78 of the inner needle hub 20.

[0043] The inner needle hub 20 is capable of accommodating the inner needle 18 and the needle holder 22. Specifically, the proximal end side of the inner needle 18 is inserted into the hub lumen 54 of the inner needle hub 20. The inner needle 18 is arranged along the axis 32. The needle holder 22 is arranged along the axis 32 in the hub lumen 54 of the inner needle hub 20. Therefore, the needle holder 22 and the inner needle 18 are arranged coaxially along the axis 32. The needle holder 22 is, for example, a rod-shaped member. The needle holder 22 holds the proximal end of the inner needle 18. A holding portion 82 is provided at the proximal end of the needle holder 22. The holding portion 82 is a flange of the needle holder 22. The holding portion 82 protrudes radially outward from the proximal end of the needle holder 22.

[0044] The needle guard structure 24 includes a biasing member 86 , a housing 88 , and an activation button 90 .

[0045] The biasing member 86 is provided in the hub lumen 54 of the inner needle hub 20. The biasing member 86 is, for example, a spring member having a resilient force in the proximal direction. The biasing member 86 is arranged along the axial direction between the stepped portion 80 and the holding portion 82 of the needle holder 22. The tip of the biasing member 86 abuts against the stepped portion 80. The base end of the biasing member 86 abuts against the holding portion 82 of the needle holder 22. The biasing member 86 biases the needle holder 22 and the inner needle 18 in the proximal direction by its resilient force.

[0046] The accommodating portion 88 is capable of covering at least the tip of the inner needle 18. The accommodating portion 88 is a portion of the hub lumen 54 of the inner needle hub 20 that is on the proximal side of the pair of insertion holes 64.

[0047] The actuation button 90 is provided at the tip of the housing 60. The actuation button 90 has an operator 92 and a wall portion 94. The operator 92 is arranged on the outer periphery of the housing 60. The operator 92 is a plate piece extending in the axial direction. The operator 92 extends from the tip of the housing 60 towards the base end. The wall portion 94 is provided at the tip of the operator 92. The wall portion 94 extends radially relative to the operator 92. The wall portion 94 passes through a pair of insertion holes 64.

[0048] The wall portion 94 has a through hole 96 and a locking portion 98. The through hole 96 is formed adjacent to the operator 92. The through hole 96 penetrates the wall portion 94 in the axial direction. The diameter of the through hole 96 is larger than the diameters of the inner needle 18, the needle holder 22, and the urging member 86. The locking portion 98 is at the end of the wall portion 94 opposite the operator 92, with the through hole 96 between them.

[0049] The actuation button 90 is biased radially outward by a biasing means (not shown). More specifically, the biasing means biases the actuation button 90 in a direction from the axis 32 toward the operator 92.

[0050] 1 and 2B , when the activation button 90 is in its initial position where no load is applied, the operator 92 is disposed radially outward relative to the outer peripheral surface of the housing 60 due to the radially outward biasing force of the biasing means. In other words, the operator 92 is raised radially outward from the outer peripheral surface of the housing 60. At this time, a part of the locking portion 98 is positioned in the hub lumen 54 of the inner needle hub 20 and locks the holding portion 82 of the needle holder 22. As a result, even if the holding portion 82 is biased in the proximal direction by the biasing member 86, the locking portion 98 can prevent the inner needle 18, the needle holder 22, and the biasing member 86 from moving in the proximal direction.

[0051] 4 and 5 , at the actuated position where a radially inward load is applied to the activation button 90 by a pressing portion 104 (described later), the operator 92 is accommodated in an accommodating recess 100 formed on the outer peripheral surface of the housing 60 against the biasing force of the biasing means. At this time, the locking portion 98 moves radially outward from the hub lumen 54 of the inner needle hub 20, and the passing hole 96 and the needle holder 22 become coaxial, so that the inner needle 18, the needle holder 22, and the biasing member 86 pass through the passing hole 96 in the proximal direction due to the biasing force of the biasing member 86.

[0052] As shown in FIG. 1 , the operating member 26 is rotatably supported by the inner needle hub 20. The operating member 26 activates the needle protection structure 24 by rotating circumferentially relative to the inner needle hub 20. The operating member 26 is made of a resin material such as polycarbonate. The operating member 26 is preferably made of a resin material with high hardness. The operating member 26 has an operating main body portion 102, a pressing portion 104, and a locking portion 106.

[0053] The operation main body 102 is rotatably supported on the outer peripheral surface 70 of the inner needle hub 20. The operation main body 102 covers the activation button 90. Specifically, the operation main body 102 is a hollow tubular member. The operation main body 102 is supported coaxially with the inner needle hub 20. The housing 60 passes through a proximal end 108 of the operation main body 102 along the axis 32. In other words, the proximal end 108 of the operation main body 102 is in contact with the outer peripheral surface of the housing 60. The proximal end 108 of the operation main body 102 is located in the proximal direction more than the activation button 90. The inner needle hub body 56 of the inner needle hub 20 passes through a distal end 110 of the operation main body 102 along the axis 32. In other words, the distal end 110 of the operation main body 102 is in contact with the outer peripheral surface 70 of the inner needle hub 20. The distal end portion 110 of the operation main body portion 102 is located further distally than the activation button 90 and the pair of flanges 66, 68. Therefore, the operation main body portion 102 is disposed so as to be rotatable relative to the outer circumferential surface 70 of the inner needle hub 20 and the outer circumferential surface of the housing 60. In addition, the activation button 90 is covered by the operation main body portion 102.

[0054] As shown in FIG. 2B , the pressing portion 104 is connected to the operation body 102. The pressing portion 104 is a pressing protrusion 114 that protrudes radially inward from the inner circumferential surface 112 of the operation body 102. As shown in FIG. 2B , the shape of the pressing protrusion 114 is trapezoidal when viewed in the axial direction. The pressing protrusion 114 has an inclined portion 116 that is inclined in the circumferential direction with respect to the radial direction. As shown in FIG. 4 , the position of the pressing protrusion 114 in the axial direction is the same as the position of the operator 92 of the actuation button 90 in the axial direction. Furthermore, as shown in FIGS. 2B , 4 , and 5 , the height of the pressing protrusion 114 in the radial direction is such that it can come into contact with the actuation button 90 and press the actuation button 90 radially inward when the operation body 102 is rotated in the circumferential direction.

[0055] 1, 2B, and 3, the position of the operating member 26 in the circumferential direction is referred to as the first position. In the first position, the pressing portion 104 (pressing protrusion 114) is not in contact with the actuation button 90, and therefore the actuation button 90 is in the initial position.

[0056] The position of the operating member 26 in the circumferential direction shown in FIGS. 4 and 5 is referred to as the second position. The second position is the rotational position when the operating member 26 is rotated in the circumferential direction from the first position (see FIGS. 1, 2B, and 3). The second position is the rotational position when the operating member 26 is rotated counterclockwise in FIG. 2B relative to the first position, so that the pressing portion 104 and the operating element 92 face each other in the radial direction. In the second position, the pressing portion 104 (pressing protrusion 114) presses the operating element 92 of the actuation button 90 radially inward, thereby moving the actuation button 90 from the initial position to the actuated position. Note that in FIG. 2B, an example of the rotational position of the pressing portion 104 (pressing protrusion 114) when the operating member 26 is rotated counterclockwise from the first position is illustrated by a two-dot chain line.

[0057] The rotation direction of the operating member 26 relative to the actuation button 90 is not limited to the examples in Figures 2B and 5. The operating member 26 may be rotated clockwise relative to the actuation button 90, and the pressing portion 104 may press the operating element 92 of the actuation button 90 radially inward when in the second position. That is, in this embodiment, the operating member 26 may be rotated either clockwise or counterclockwise in the circumferential direction relative to the actuation button 90. Note that when the operating member 26 is rotated clockwise and the pressing portion 104 presses the operating element 92, the locking portion 106 must also rotate clockwise together with the operation main body 102 and the pressing portion 104.

[0058] As shown in FIG. 1 , the locking portion 106 is connected to the distal end portion 110 of the operation body 102. That is, the locking portion 106 protrudes from the operation body 102 in the distal direction. The locking portion 106 may be molded integrally with the operation body 102. In this way, when the operation body 102 rotates in the circumferential direction, the operation body 102 and the locking portion 106 rotate integrally in the circumferential direction. Alternatively, the locking portion 106 may be inseparably connected to the operation body 102. When the operation body 102 and the locking portion 106 are inseparably connected, the operation body 102 and the locking portion 106 can rotate together in the circumferential direction.

[0059] The locking portion 106 is rotatably supported on the outer peripheral surface 70 of the inner needle hub 20. The locking portion 106 is a tubular member. The locking portion 106 has a smaller diameter than the manipulation body portion 102. The locking portion 106 is supported coaxially with the inner needle hub 20. The inner needle hub body 56 of the inner needle hub 20 passes through a proximal end 118 of the locking portion 106 along the axis 32. In other words, the proximal end 118 of the locking portion 106 is in contact with the outer peripheral surface 70 of the inner needle hub 20. The proximal end 118 of the locking portion 106 is located between the distal end 110 of the manipulation body portion 102 and the slip-out prevention portion 72 (rib 74). Therefore, the locking portion 106 is rotatably disposed on the outer peripheral surface 70 of the inner needle hub 20.

[0060] A distal opening 120 is formed at the distal end of the locking part 106, into which the hub base end 42 of the outer needle hub 16 can be inserted. A female thread portion 124 is formed on an inner circumferential surface 122 of the locking part 106. By inserting the hub base end 42 of the outer needle hub 16 into the locking part 106 and rotating the outer needle hub 16 and the operating member 26 relative to each other in the circumferential direction, the lock fitting portion 46 of the outer needle hub 16 and the female thread portion 124 are threadedly engaged. As a result, the outer needle hub 16 is restrained by the locking part 106 so as not to be able to move in the axial direction, and the outer needle hub 16 is fixed to the locking part 106. Furthermore, when the operating member 26 rotates circumferentially from the first position to the second position, the lock fitting portion 46 moves distally relative to the female thread portion 124. As a result, the fixed state between the locking part 106 and the outer needle hub 16 is released.

[0061] As shown in FIG. 2A , the outer needle hub 16 has a pair of outer needle engaging portions 130. The pair of outer needle engaging portions 130 are provided on the hub base end 42 of the outer needle hub 16. More specifically, the outer needle engaging portions 130 are a pair of fitting recesses 132 formed on the inner circumferential surface of the hub base end 42, part of the inner circumferential surface 44 of the outer needle hub 16. The pair of fitting recesses 132 are provided in the portion of the base end opening of the outer needle hub 16. The pair of fitting recesses 132 face each other across the axis 32. That is, the pair of fitting recesses 132 are provided on the inner circumferential surface of the hub base end 42 at 180° intervals in the circumferential direction.

[0062] The inner needle hub 20 has an inner needle engaging portion 134. The inner needle engaging portion 134 is a pair of fitting protrusions 136 formed on the outer peripheral surface of the hub tip portion 58 of the outer peripheral surface 70 of the inner needle hub 20. The pair of fitting protrusions 136 face each other across the axis 32. That is, the pair of fitting protrusions 136 are provided on the outer peripheral surface of the hub tip portion 58 at 180° intervals in the circumferential direction.

[0063] When the inner needle hub 20 is connected to the proximal end of the outer needle hub 16, the outer needle engaging portion 130 and the inner needle engaging portion 134 engage with each other. That is, the pair of engaging recesses 132 engage with the pair of engaging protrusions 136. This prevents the inner needle hub 20 from rotating in the circumferential direction in conjunction with the rotation of the operating member 26 in the circumferential direction. That is, the inner needle hub 20 can be effectively prevented from rotating together with the operating member 26.

[0064] The outer needle engaging portion 130 and the inner needle engaging portion 134 are not limited to being engaged in the circumferential direction as shown in FIG. 2A . As shown in FIGS. 6A and 6B , the outer needle engaging portion 130 and the inner needle engaging portion 134 may be engaged in the axial direction. Specifically, the outer needle engaging portion 130 is a pair of fitting recesses 142 recessed from the base-end surface toward the tip at the hub base end 42 of the outer needle hub 16. The pair of fitting recesses 142 face each other across the axis 32. The inner needle engaging portion 134 is a pair of fitting protrusions 144 protruding in the tip direction from the inner needle hub 20. The pair of fitting protrusions 144 are provided on the outer peripheral surface 70 of the inner needle hub 20. The pair of fitting protrusions 144 face each other across the axis 32. The base ends of the pair of fitting protrusions 144 protrude radially outward from the outer peripheral surface 70 of the inner needle hub 20. The pair of fitting protrusions 144 extend in the distal direction from the base end that protrudes radially outward. The pair of fitting recesses 142 and the pair of fitting protrusions 144 are fitted together in the axial direction. Even in this case, when the operating member 26 is rotated in the circumferential direction, the inner needle hub 20 is prevented from rotating in the circumferential direction in conjunction with the circumferential rotation of the operating member 26. This effectively prevents the inner needle hub 20 from rotating together with the operating member 26.

[0065] It is also possible for the outer needle engaging portion 130 to be a pair of engaging convex portions that protrude in the proximal direction, and for the inner needle engaging portion 134 to be a pair of engaging concave portions that are recessed in the proximal direction. Even in this case, the outer needle engaging portion 130 and the inner needle engaging portion 134 engage in the axial direction, thereby effectively preventing the inner needle hub 20 from rotating together with the operating member 26 when the operating member 26 is rotated in the circumferential direction.

[0066] Furthermore, the number of mating convex portions 136, 144 (see Figures 1, 2A, 3, 4, 6A and 6B) and the number of mating recesses 132, 142 are not limited to two each. One mating convex portion 136, 144 may be provided on the inner needle hub 20, and one mating recess 132, 142 may be provided on the outer needle hub 16. Alternatively, three or more mating convex portions 136, 144 may be provided on the inner needle hub 20, and three or more mating recesses 132, 142 may be provided on the outer needle hub 16. In either case, when the operating member 26 is rotated in the circumferential direction, the inner needle hub 20 can be effectively prevented from rotating together with the operating member 26.

[0067] Next, the operation of placing the outer needle member 28 in the living body 12 using the catheter assembly 10 will be described.

[0068] As shown in Figure 1, the user prepares the catheter assembly 10 in an initial position where no load is applied to the activation button 90. In this case, the operating member 26 is in the first position, as shown in Figure 2B.

[0069] Next, as shown in Figure 3, the user punctures the skin 50 of the living body 12 with the tip of the inner needle 18 of the catheter assembly 10. At this time, the tip of the inner needle 18 of the inner needle member 30 punctures the blood vessel 140, and the tip of the outer needle 14 is inserted into the blood vessel 140. When the tip of the inner needle 18 punctures the blood vessel 140, blood flows into the housing portion 88 of the hub lumen 54 via the inner needle 18. The user can visually check the blood that has flowed into the housing portion 88 to confirm that the blood vessel 140 has been secured.

[0070] Next, the user pulls the inner needle member 30 out from the outer needle member 28 in the proximal direction to remove it.

[0071] Specifically, as shown in FIG. 2B , the user rotates the operating member 26 in the circumferential direction from the first position to the second position (see FIG. 5 ). As the operating member 26 rotates in the circumferential direction, the pressing protrusion 114 approaches the operating element 92, and as shown by the two-dot chain line, the pressing protrusion 114 comes into contact with the operating element 92. When the user further rotates the operating member 26 in the circumferential direction, a pressing force directed radially inward from the pressing protrusion 114 acts on the operating element 92. As a result, the actuation button 90 moves radially inward. When the operating member 26 rotates to the second position shown in FIG. 5 , the passage hole 96 of the actuation button 90 and the needle holder 22 are coaxially arranged, as shown in FIG. 4 . As a result, the needle holder 22 is released from the blocked state by the locking portion 98. The inner needle 18 and the needle holder 22 move proximally due to the biasing force of the biasing member 86. As a result, the inner needle 18 and the needle holder 22 are housed in the housing portion 88 .

[0072] Furthermore, rotation of the operating member 26 from the first position to the second position causes the locking portion 106 (see FIG. 1) to rotate relative to the outer needle hub 16 and the inner needle hub 20. As a result, as shown in FIG. 4, the threaded state between the lock fitting portion 46 and the female thread portion 124 is released, making it possible to remove the outer needle hub 16 from the locking portion 106. The user removes the inner needle member 30 in the proximal direction from the outer needle member 28. This completes the removal of the inner needle member 30 from the outer needle member 28.

[0073] Thereafter, the user connects a syringe, a medicinal liquid tube, or the like to the hub proximal end 42 of the outer needle hub 16 placed on the skin 50 of the living body 12. This allows the medicinal liquid to be administered into the living body 12 through the outer needle 14.

[0074] This embodiment has the following advantages.

[0075] As shown in FIG. 2B , when the user rotates the operating member 26 from a first position to a second position (see FIG. 5 ) around the axis 32 of the inner needle 18 (see FIG. 1 ) (in the circumferential direction), the pressing portion 104 presses the activation button 90, thereby activating the needle protection structure 24 and covering at least the tip of the inner needle 18 with the housing portion 88 (see FIG. 4 ). Furthermore, by rotating the operating member 26 in the circumferential direction from the first position to the second position, the fixed state between the locking portion 106 and the outer needle hub 16 is released. In this way, in conjunction with the rotation of the operating member 26, the action of covering at least the tip of the inner needle 18 and the action of releasing the fixed state between the locking portion 106 and the outer needle hub 16 are simultaneously performed. As a result, the tip of the inner needle 18 is always covered by the needle protection structure 24, preventing accidental puncture after the inner needle 18 is removed from the outer needle hub 16.

[0076] As shown in FIG. 1, the operation body part 102 covers the activation button 90 provided on the inner needle hub 20, so the user will not directly press the activation button 90. This prevents the activation button 90 from being accidentally operated. Furthermore, when the operating member 26 rotates from the first position (see FIG. 2B) to the second position (see FIG. 5), the activation button 90 can be effectively pressed by the pressing protrusion 114 formed on the inner circumferential surface 112 of the operation body part 102. In this manner, in this embodiment, the activation button 90 is pressed simultaneously with the withdrawal of the inner needle member 30 from the outer needle member 28. Therefore, the needle tip of the inner needle 18 can be effectively protected during the user's procedure.

[0077] When the manipulation main body part 102 is displaced in the proximal direction, the distal end part 110 of the manipulation main body part 102 abuts against the flange 66 of the inner needle hub 20. This effectively prevents the manipulation member 26 from separating from the inner needle hub 20 in the proximal direction.

[0078] When the operating member 26 is located at the first position (see FIGS. 1 and 3), the protrusion 48 threads into the female thread portion 124, thereby fixing the outer needle hub 16 to the locking portion 106. Furthermore, when the operating member 26 is rotated from the first position to the second position (see FIGS. 4 and 5), the protrusion 48 is removed from the female thread portion 124, thereby releasing the fixed state between the locking portion 106 and the outer needle hub 16. This allows the outer needle hub 16 to be effectively fixed to the locking portion 106 when the operating member 26 is located at the first position. Furthermore, when the operating member 26 is rotated from the first position to the second position, the fixed state between the locking portion 106 and the outer needle hub 16 can be effectively released.

[0079] 2A , when the inner needle hub 20 is connected to the proximal end of the outer needle hub 16, the outer needle engagement portion 130 and the inner needle engagement portion 134 engage with each other, thereby preventing circumferential rotation of the inner needle hub 20 that accompanies circumferential rotation of the operating member 26. This makes it possible to prevent the inner needle hub 20 from rotating together with the operating member 26 when the operating member 26 is rotated in the circumferential direction.

[0080] When the inner needle hub 20 is connected to the base end of the outer needle hub 16, the fitting recesses 132, 142 fit into the fitting protrusions 136, 144. This effectively prevents the inner needle hub 20 from rotating together with the operating member 26 when the operating member 26 is rotated in the circumferential direction. Furthermore, the fitting recesses 132, 142 are formed on the hub base end 42 of the outer needle hub 16. This allows the fitting recesses 132, 142 to fit into the fitting protrusions 136, 144 while ensuring sealing between the inner needle hub 20 and the outer needle hub 16 when the inner needle hub 20 is connected to the base end of the outer needle hub 16.

[0081] As shown in Figure 1, by providing a slip-out prevention section 72 that prevents the operating member 26 from coming off the inner needle hub 20, the operating member 26 is prevented from coming off the inner needle hub 20, so that the pressing operation of the operating button 90 by the pressing section 104 and the operation of releasing the fixed state between the locking section 106 and the outer needle hub 16 can be performed effectively.

[0082] The base end 118 of the locking portion 106 is located further proximally than the rib 74 and is in contact with the outer peripheral surface 70 of the inner needle hub 20, and therefore when the locking portion 106 is displaced in the distal direction, the base end 118 of the locking portion 106 abuts against the rib 74. This makes it possible to effectively prevent the operating member 26 from detaching from the inner needle hub 20 in the distal direction.

[0083] Although the present disclosure has been described in detail, the present disclosure is not limited to the above-described individual embodiments. Various additions, substitutions, modifications, partial deletions, etc. are possible to these embodiments without departing from the gist of the present disclosure or the gist of the present disclosure derived from the content of the claims and their equivalents. [Explanation of symbols]

[0084] 10...Catheter assembly 14...Outer needle 16...Outer needle hub 18...Inner needle 20...Inner needle hub 24...needle protection structure 26...Operating member 34...lumen 86... Urging member 88...Storage section 90...Activation button 102...Operation main body 104...Pressing part 106...Rock section

Claims

1. a tubular outer needle; an outer needle hub connected to the proximal end of the outer needle; an inner needle that is inserted into the inner cavity of the outer needle and protrudes from the tip of the outer needle in a distal direction; an inner needle hub provided at the proximal end of the inner needle and connected to the proximal end of the outer needle hub; a needle protection structure that covers at least the tip of the inner needle by utilizing the elastic force of a biasing member; an operating member that is rotatably supported by the inner needle hub and that activates the needle protection structure by rotating in a circumferential direction around the axis of the inner needle; Equipped with The needle protection structure includes: The biasing member; a housing portion that is movable relative to the inner needle in the axial direction of the inner needle and that is capable of covering at least the tip end of the inner needle; an actuation button provided so as to be movable between an initial position and an actuation position; and when the actuation button is located at the initial position, relative movement between the inner needle and the housing portion is restricted against the elastic force of the biasing member, when the actuation button moves from the initial position to the actuated position, the inner needle and the housing portion become capable of relative movement, and the housing portion covers at least the tip end of the inner needle by utilizing the elastic force of the biasing member; The operating member is an operation main body portion rotatably supported on an outer peripheral surface of the inner needle hub; a pressing portion connected to the operation body portion and capable of pressing the operation button; a locking portion connected to the operation main body portion and connectable to the base end of the outer needle hub; and When the operating member is located at a first position in the circumferential direction, the pressing portion is in a non-contact state with the activation button, whereby the activation button is located at the initial position, and the outer needle hub is restrained by the locking portion so as to be immovable in the axial direction, whereby the outer needle hub is fixed to the locking portion, a catheter assembly in which, when the operating member rotates from the first position to the second position along the circumferential direction, the pressing portion presses the activation button to move the activation button from the initial position to the activation position, and the fixed state between the locking portion and the outer needle hub is released.

2. The catheter assembly according to claim 1, the actuation button is provided on the inner needle hub, the operation main body is a tubular member rotatably arranged on the outer circumferential surface of the inner needle hub so as to cover the actuation button, the pressing portion is a pressing protrusion that protrudes from an inner circumferential surface of the operation main body portion in a radial direction of the inner needle that is perpendicular to the axial direction, When the operating member rotates from the first position to the second position along the circumferential direction, the pressing protrusion presses the actuation button radially inward.

3. The catheter assembly according to claim 2, a distal end portion of the operation main body portion contacts the outer peripheral surface of the inner needle hub, a flange protruding in the radial direction is formed on the outer circumferential surface of the inner needle hub, a catheter assembly, wherein the flange is located on the outer peripheral surface of the inner needle hub in a proximal direction relative to the distal end of the operating body portion.

4. The catheter assembly according to any one of claims 1 to 3, the locking portion is a tubular member that is located distally of the operation main body portion and the pressing portion and is rotatably disposed on the outer circumferential surface of the inner needle hub, a protrusion is provided at the base end of the outer needle hub, An internal thread portion that screws onto the protrusion is provided on an inner circumferential surface of the locking portion, When the operating member is located at the first position, the protrusion is threadedly engaged with the female thread portion, thereby fixing the outer needle hub to the lock portion, A catheter assembly in which, when the operating member is rotated from the first position to the second position, the threaded engagement between the protrusion and the female thread portion is released, thereby releasing the fixed state between the locking portion and the outer needle hub.

5. The catheter assembly according to any one of claims 1 to 3, the outer needle hub has an outer needle engaging portion provided on the outer needle hub, the inner needle hub has an inner needle engaging portion provided on the inner needle hub, A catheter assembly in which, when the inner needle hub is connected to the base end of the outer needle hub, the inner needle engaging portion and the outer needle engaging portion engage with each other, thereby preventing the inner needle hub from rotating in the circumferential direction in conjunction with the rotation of the operating member in the circumferential direction.

6. The catheter assembly according to claim 5, the outer needle engaging portion is a fitting recess or a fitting protrusion formed on the base end portion of the outer needle hub, the inner needle engaging portion is a fitting convex portion or a fitting concave portion formed on the inner needle hub, A catheter assembly, wherein the mating recess and the mating protrusion are mated when the inner needle hub is connected to the base end of the outer needle hub.

7. The catheter assembly according to any one of claims 1 to 3, The catheter assembly further comprises a slip-out prevention portion provided on the inner needle hub to prevent the operating member from coming off the inner needle hub.

8. The catheter assembly according to claim 7, the locking portion is a tubular member that is located distally of the operation main body portion and the pressing portion and is rotatably disposed on the outer circumferential surface of the inner needle hub, the slip-out prevention portion is a rib that protrudes from the outer circumferential surface of the inner needle hub in a radial direction of the inner needle that is perpendicular to the axial direction, a proximal end of the locking portion is located in the proximal direction relative to the rib and is in contact with the outer peripheral surface of the inner needle hub.

Images