Catheter Assembly

Abstract

To provide a catheter assembly capable of significantly improving usability even when a connector is connected to a catheter hub.SOLUTION: A catheter assembly 10A includes an inner needle 12, a needle hub 20, a catheter 40, and a catheter hub 50. The catheter assembly includes: a catheter operation part 70 that enables operation of relative movement of the catheter and the catheter hub with respect to the inner needle; a support member 27 that supports the catheter during movement of the catheter; and a connector 60 that is connected to the catheter hub and can be connected with another medical device. The catheter assembly has a restriction part 100A that restricts free displacement of the connector with respect to the catheter hub.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a catheter assembly used, for example, when performing fluid infusion, blood transfusion, or the like. [Background technology]

[0002] When establishing an introduction site for infusion or blood transfusion in a patient, a catheter assembly (catheter insertion device) having a multi-structure needle with an inner needle (needle cannula) inserted into a catheter is used, as disclosed in Patent Document 1, for example. When using this catheter assembly, a user inserts the multi-structure needle into a patient, advances the catheter relative to the inner needle to insert it into a blood vessel, and then detaches the inner needle from the catheter to place the catheter in place.

[0003] In addition, in the catheter assembly disclosed in Patent Document 1, one end of an extension line is connected to a catheter hub (rigid hub) that fixes the base end of the catheter. A connector (extension line hub) to which a medical device can be connected is fixed to the end of this extension line. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2016-530934 Summary of the Invention [Problem to be solved by the invention]

[0005] Incidentally, in a configuration in which a connector is connected to a catheter hub via a relay tube (extension line) as in the catheter assembly disclosed in Patent Document 1, the user performs the puncture operation while the connector remains in a state in which it can be freely displaced. When the connector is in a free state like this, the connector gets in the way and makes it difficult to puncture the patient. When puncturing, it is conceivable that the user may grasp the tube and connector together with the needle hub (handle) that fixes the inner needle, but in this case, the operability when inserting the catheter (advancing the catheter relative to the inner needle) will decrease.

[0006] The present invention has been made to solve the above-mentioned problems, and has an object to provide a catheter assembly that can significantly improve its usability even in a configuration in which a connector is connected to a catheter hub. [Means for solving the problem]

[0007] In order to achieve the above object, a catheter assembly according to one aspect of the present invention includes an inner needle, a needle hub fixed to a proximal end of the inner needle, and a catheter member through which the inner needle is inserted. A first lumen and a second lumen extending parallel to the first lumen. the catheter includes a catheter, a catheter hub through which the inner needle is inserted and which is fixed to a base end of the catheter, a catheter operation unit which enables relative movement of the catheter and the catheter hub with respect to the inner needle, a support unit which supports the catheter when the catheter is moved, and a connector which is connected to the catheter hub and which is capable of connecting other medical devices; Through the relay tube The catheter hub has a limiting portion that limits free displacement of the connector relative to the catheter hub, and the limiting portion functions when the inner needle is inserted into the connector. The relay tube is connected to the outer periphery of the catheter hub and communicates with the second lumen. do. Effect of the Invention

[0008] The catheter assembly described above has a limiting portion that limits the free displacement of the connector relative to the catheter hub, thereby preventing the connector from interfering with user operations when the inner needle and catheter are inserted into the body, when the catheter is inserted into the body, etc. In other words, the usability of the catheter assembly can be significantly improved even in a configuration in which the connector is connected to the catheter hub. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view of a catheter assembly according to a reference example. [Diagram 2] FIG. 2 is an exploded perspective view of the catheter assembly of FIG. 1. [Diagram 3] Fig. 3A is a side cross-sectional view showing the tip side of the multi-structure needle in an initial state, and Fig. 3B is a plan cross-sectional view showing the catheter hub and connector in an initial state. [Figure 4] Fig. 4A is a first explanatory view showing the operation of the catheter assembly when in use, and Fig. 4B is a second explanatory view showing the operation of the catheter assembly when in use. [Diagram 5] Fig. 5A is a third explanatory view showing the operation of the catheter assembly when in use, and Fig. 5B is a fourth explanatory view showing the operation of the catheter assembly when in use. [Figure 6] Fig. 6A is a cross-sectional view that shows a first configuration example of the limiting portion, Fig. 6B is a cross-sectional view that shows a second configuration example of the limiting portion, and Fig. 6C is a cross-sectional view that shows a third configuration example of the limiting portion. [Figure 7] Fig. 7A is a partial plan view of a catheter assembly according to a first modified example, and Fig. 7B is an explanatory view showing the clamp of Fig. 7A. [Figure 8] FIG. 11 is a partial plan view of a catheter assembly according to a second modified example. [Figure 9] Figure 9A is a partial plan view of a catheter assembly according to a first embodiment of the present invention, and Figure 9B is a plan cross-sectional view of the catheter hub and connector of Figure 9A. [Figure 10] FIG. 6 is a partial plan view of a catheter assembly according to a second embodiment of the present invention. [Figure 11] Fig. 11A is a partial plan view of a catheter assembly according to a third embodiment of the present invention, Fig. 11B is a partial plan view of a catheter assembly according to a fourth embodiment of the present invention, and Fig. 11C is a partial cross-sectional plan view of a catheter assembly according to a fifth embodiment of the present invention. [Figure 12] FIG. 13 is a perspective view of a catheter assembly according to a third modified example. [Figure 13] FIG. 13 is a partial plan view of the catheter assembly of FIG. 12. [Figure 14] Fig. 14A is a first side view showing the operation of the catheter operation section of the catheter assembly of Fig. 12. Fig. 14B is a second side view showing the operation of the catheter operation section of the catheter assembly of Fig. 12. [Figure 15] Fig. 15A is a partial plan view of a catheter assembly according to a fourth modified example, and Fig. 15B is a partial plan view of a catheter assembly according to a fifth modified example. [Figure 16] Fig. 16A is a partial side view of a catheter assembly according to a sixth modified example, and Fig. 16B is a partial plan view of the catheter assembly of Fig. 16A. [Figure 17] Figure 17A is a partial side view showing the operation of the catheter manipulation unit of Figure 16A, and Figure 17B is a partial plan view showing the operation of the catheter manipulation unit of Figure 16B. [Figure 18] FIG. 13 is a schematic cross-sectional view of a catheter assembly according to a seventh modified example. [Figure 19] Fig. 19A is a first partial plan view of a catheter assembly according to an eighth modified example, and Fig. 19B is a second partial plan view showing the operation of the catheter assembly of Fig. 19A. [Figure 20] Fig. 20A is a partial plan view of a catheter assembly according to a ninth modified example, and Fig. 20B is a plan view of the clamp of Fig. 20A. [Figure 21] Figure 21A is a first partial plan view of a catheter assembly according to a tenth modified example, Figure 21B is a second partial plan view showing the operation of the catheter assembly of Figure 21A, and Figure 21C is a third partial plan view showing the operation of the catheter assembly of Figure 21A. [Figure 22] Fig. 22A is a partial plan view that shows a schematic diagram of a catheter assembly according to an eleventh modified example, and Fig. 22B is a partial plan view that shows a schematic diagram of a catheter assembly according to a twelfth modified example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will now be described in detail with reference to preferred embodiments thereof and accompanying drawings.

[0011] [Reference example] As shown in Fig. 1, the catheter assembly 10A according to the reference example has a catheter 40 that is inserted and left in the body of a patient (living body), and is used to form an inlet and outlet for liquids (medicinal fluids and blood) during infusion, blood transfusion, etc. The catheter 40 according to this reference example is configured as a catheter (e.g., a central venous catheter, PICC, midline catheter, etc.) that is longer than a peripheral venous catheter. The catheter 40 may also be a peripheral venous catheter that is shorter than a central venous catheter. Furthermore, the catheter 40 is not limited to a venous catheter, and may also be an arterial catheter such as a peripheral arterial catheter.

[0012] 1 and 2, the catheter assembly 10A includes an inner needle 12, a needle hub 20 fixed to the base end of the inner needle 12, the above-mentioned catheter 40, and a catheter hub 50 fixed to the base end of the catheter 40. Furthermore, the catheter assembly 10A includes a catheter operation unit 70 capable of operating the advancement and retreat of the catheter 40 and the catheter hub 50 relative to the inner needle 12, and a safety mechanism 90 that covers the needle tip 13 of the inner needle 12 when the inner needle 12 is removed from the catheter hub 50.

[0013] In this catheter assembly 10A, in an assembled state (initial state) before use, the inner needle 12 is inserted into the catheter 40 to form a multi-layered needle 11. The multi-layered needle 11 has a needle tip 13 of the inner needle 12 protruding, and the inner needle 12 and the catheter 40 can be inserted into a patient together. The needle hub 20 is configured as a housing 21 that accommodates the base end side of the multi-layered needle 11 therein and also accommodates the catheter hub 50, the catheter operating section 70, and the safety mechanism 90.

[0014] When using the catheter assembly 10A, a user such as a doctor or nurse grasps the housing 21 in the initial state, and inserts the multi-structure needle 11 into the patient's body, bringing the needle tip 13 into a punctured state in which it has reached the blood vessel. The user then advances the catheter 40 relatively to the inner needle 12 while maintaining the punctured state, thereby inserting the catheter 40 into the blood vessel. Thereafter, the inner needle 12 is retracted and removed from the catheter 40, so that the catheter 40 is placed in the blood vessel. In the indwelling state, the catheter 40 can perform treatments such as administering medicinal fluid or blood, or drawing blood, via a medical device (not shown) connected to a catheter hub 50 and a connector 60 (described later). Each component of the catheter assembly 10A will be described in detail below.

[0015] The inner needle 12 of the catheter assembly 10A is configured as a hollow tube having a rigidity capable of puncturing the skin of a living body, and is provided with a sharp needle tip 13 at its tip. The needle tip 13 is formed to be slightly flatter than the body of the inner needle 12. This prevents the needle tip 13 from coming off a safety mechanism 90, which will be described later. Inside the inner needle 12, a hollow portion 14 is provided along the axial direction, and the hollow portion 14 communicates with a tip opening 14a provided in the needle tip 13. As shown in FIG. 3A, the inner needle 12 is provided with a hole 14b penetrating the hollow portion 14 and the outer surface. The inner needle 12 may have a solid structure without the hollow portion 14, or may have a groove (not shown) on the outer circumferential surface instead of the hole 14b.

[0016] Examples of materials constituting the inner needle 12 include metal materials such as stainless steel, aluminum or an aluminum alloy, titanium or a titanium alloy, or hard resins, ceramics, etc. The inner needle 12 is firmly fixed to the housing 21 by an appropriate fixing means such as fusion, adhesion, or insert molding.

[0017] The housing 21 of the catheter assembly 10A can be handled integrally with the inner needle 12, and is configured as a gripping member for the user to grip when inserting the multi-structure needle 11. The housing 21 is formed in an overall elongated box shape (bowl shape) having a bottom wall 22 and a pair of side walls 23 protruding from both sides of the bottom wall 22. The housing 21 is designed to have an appropriate size (thickness and length) so that it is easy for the user to grip.

[0018] The housing 21 is provided with an accommodating space 24 extending along the longitudinal direction of the housing 21, defined by a bottom wall 22 and a pair of side walls 23. A block-shaped needle holding portion 25 is provided at the base end of the accommodating space 24, which connects to and holds the base end of the inner needle 12. The needle holding portion 25 holds the inner needle 12 at a predetermined height in the center in the width direction of the housing 21 (accommodating space 24).

[0019] A pair of side walls 23 of the housing 21 sandwiching the accommodation space 24 extend parallel to each other along the longitudinal direction. The pair of side walls 23 have a tip side formed higher than the base side, and are provided with a groove-shaped rail portion 23a on the inner surface of the tip side. The pair of rail portions 23a slidably accommodate the side edge 71a of the catheter operation section 70. The tip side of one of the pair of side walls 23 (the left side wall 23 in FIG. 1) has a bulging portion 26 that bulges outward in the width direction. A support member 27 (support portion) that supports the catheter 40 when the catheter 40 moves is attached to a cut-out space (disposition recess 26a) of this bulging portion 26.

[0020] The support member 27 is rotatably supported by the side wall 23 and has a sliding support portion 27a that protrudes rightward into the storage space 24 of the housing 21. This sliding support portion 27a rubs against the catheter 40 (multiple-structure needle 11) held by the catheter operation portion 70 when the catheter 40 advances. Note that the sliding support portion 27a does not have to be in contact with the catheter 40 in the initial state or when the catheter 40 moves relative to the housing 21.

[0021] The support member 27 has a pivotal support portion 27b pivotally supported by the bulging portion 26, and the pivotal support portion 27b has a groove (not shown) at its upper end portion that receives the side edge 71a of the catheter operation portion 70 in the initial state. The presence of the side edge 71a in this groove restricts rotation and allows the support member 27 to stand by and support the catheter 40. On the other hand, when the catheter operation portion 70 advances, the side edge 71a of the support member 27 comes out of the groove, allowing the support member 27 to rotate around the pivotal support portion 27b, and the catheter operation portion 70 comes into contact with the support member 27, causing the sliding support portion 27a to move toward the outside of the side wall 23. As a result, the catheter hub 50, the catheter operation portion 70, and the like are smoothly delivered from the housing 21 while the support member 27 is held in the housing 21.

[0022] The material of the housing 21 is not particularly limited, but may be, for example, a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer, etc. In the illustrated example, the housing 21 is configured such that the upper surface of the storage space 24 is open, but the housing 21 may be formed in a rectangular tube shape with the storage space 24 covered by an upper wall.

[0023] On the other hand, the catheter 40 of the catheter assembly 10A has an outer shape that is circular in a cross section perpendicular to the axial direction. The length of the catheter 40 is not particularly limited and can be appropriately designed depending on the application, various conditions, etc., and is set to, for example, about 14 to 500 mm.

[0024] 3A, the catheter 40 according to this embodiment is configured as a multi-lumen type having multiple (two in this embodiment) lumens 41 therein. Specifically, it includes a main lumen 42 through which the inner needle 12 is inserted and disposed in the initial state, and a sub-lumen 43 extending parallel to the main lumen 42. The main lumen 42 and the sub-lumen 43 are each formed in a perfect circular shape in a cross-sectional view perpendicular to the axial direction.

[0025] The main lumen 42 is formed over the entire axial length of the catheter 40, and communicates with a tip opening 42a formed at the tip of the catheter 40 and a first base end opening 42b (see FIG. 3) formed at the base end of the catheter 40. The tip opening 42a exposes the needle tip 13 of the inner needle 12. The inner circumferential surface of the catheter 40 constituting the main lumen 42 includes a tip inner circumferential surface 44a having a narrow gap with the outer circumferential surface of the inner needle 12, a basic inner circumferential surface 44b forming a wider gap than the tip inner circumferential surface 44a, and a tapered inner circumferential surface 44c extending between the tip inner circumferential surface 44a and the basic inner circumferential surface 44b.

[0026] The tip inner circumferential surface 44a has a diameter that is equal to or slightly smaller than the outer diameter of the outer circumferential surface of the inner needle 12, so that it is in close contact with the outer circumferential surface of the inner needle 12. The tapered inner circumferential surface 44c has a diameter that gradually decreases toward the tip inner circumferential surface 44a over a short axial range. The basic inner circumferential surface 44b constitutes most of the inner circumferential surface in the axial direction of the main lumen 42. The diameter of the basic inner circumferential surface 44b is larger than the outer diameter of the outer circumferential surface of the inner needle 12, so that the inner needle 12 slides smoothly against the catheter 40. In the initial state, the above-mentioned hole 14b of the inner needle 12 faces the basic inner circumferential surface 44b and communicates with the main lumen 42.

[0027] The sub-lumen 43 is separated from the main lumen 42 in the axial direction by a partition wall 45 formed in the catheter 40 along the axial direction. In this reference example, the inner circumferential surface of the sub-lumen 43 is set to a diameter smaller than the diameter of the inner circumferential surface (tip inner circumferential surface 44a) of the main lumen 42, and extends along the axial direction of the catheter 40 with a constant diameter.

[0028] The sub-lumen 43 is bent radially outward at a midpoint on the distal end side of the catheter 40 and communicates with a side opening 43a formed on the outer circumferential surface (side) of the catheter 40. The side opening 43a is provided on the proximal end side of the distal opening 42a at a position spaced a predetermined distance or more from the distal opening 42a. The proximal end side of the sub-lumen 43 communicates with a second proximal opening 43b (see FIG. 3), and the second proximal opening 43b is adjacent to the first proximal opening 42b.

[0029] The catheter 40 is composed of a main body 46 which constitutes most of the axial direction, and a soft tip 47 which is provided at the tip of the main body 46 and is softer than the main body 46. The connecting boundary between the main body 46 and the soft tip 47 overlaps each other in a tapered shape, gradually changing the physical properties of the catheter 40. The inside of the soft tip 47 forms a tip inner circumferential surface 44a of the main lumen 42, and the very tip of this tip inner circumferential surface 44a forms a tip opening 42a.

[0030] The material of the main body 46 is not particularly limited, but a transparent soft resin material may be used. For example, the material of the main body 46 may be a fluororesin such as polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), or perfluoroalkoxy fluorine resin (PFA), an olefin resin such as polyethylene or polypropylene, or a mixture thereof, polyurethane, polyester, polyamide, polyether nylon resin, or a mixture of an olefin resin and an ethylene-vinyl acetate copolymer. The material of the soft tip 47 is not particularly limited, but a resin material such as polyurethane may be used.

[0031] 1 to 3B, the base end of the catheter 40 is fixed to the tip portion inside the catheter hub 50 by an appropriate fixing means such as crimping, fusion, adhesion, etc. The catheter hub 50 is exposed on the patient's skin with the catheter 40 inserted into the patient's blood vessel, and is left indwelling together with the catheter 40 by being affixed with tape or the like. The material constituting the catheter hub 50 is not particularly limited, and for example, the materials listed for the housing 21 may be appropriately adopted.

[0032] The catheter hub 50 is formed in a cylindrical shape tapered toward the tip. A connector 60 is connected to the catheter hub 50 in correspondence with the catheter 40 configured as a multi-lumen catheter. That is, a first medical device (not shown) (such as a connector of a medical tube, a syringe, etc.) is connected to the catheter hub 50 to supply a medicinal liquid, and a second medical device (not shown) (such as a connector of another medical tube, a syringe, etc.) is connected to the connector 60. Hereinafter, the catheter hub 50 is referred to as a main hub 51, and the connector 60 is also referred to as a sub-hub 61. The main hub 51 is a first port through which one of two types of medicinal liquid flows in during infusion, and the sub-hub 61 is a second port through which the other of the two types of medicine flows in.

[0033] The main hub 51 fixes the catheter 40 at its tip, and has a main space 52 on the base end side of the fixing part. The main space 52 communicates with the main lumen 42 (first base end opening 42b) and also communicates with a base end opening 52a at the base end of the main hub 51, through which the inner needle 12 is inserted in the initial state. A sub-flow passage 53 is provided inside the main hub 51, which communicates with the sub-lumen 43 (second base end opening 43b) of the catheter 40 and also communicates with a sub-space 62 in the sub-hub 61. The sub-flow passage 53 curves from the base end of the catheter 40 in the main hub 51 and extends toward the side circumferential surface of the main hub 51.

[0034] The sub-hub 61 is formed in a cylindrical shape having a sub-space portion 62 therein, and is connected to the main hub 51 via the relay tube 58. The relay tube 58 is inserted into the tip side of the sub-space portion 62, and the sub-space portion 62 communicates with a base end opening 62a at the base end of the sub-hub 61.

[0035] The relay tube 58 has flexibility that allows the sub-hub 61 to be freely displaced relative to the catheter hub 50. A tube lumen 59 is provided inside the relay tube 58, and the tube lumen 59 communicates with the sub-flow passage 53 and the sub-space portion 62. The relay tube 58 is fixed to a tube protrusion 54 provided on the main hub 51 (and is inserted into the sub-flow passage 53).

[0036] The main hub 51 and the sub-hub 61 are formed to have the same shape. Specifically, the main hub 51 and the sub-hub 61 are configured to have body portions 55a, 63a whose outer diameter is generally constant along the axial direction, and tapered portions 55b, 63b that are connected to the tips of the body portions 55a, 63a and gradually decrease in diameter toward the tip. One end of the relay tube 58 is connected to the tapered portion 55b of the main hub 51. The other end of the relay tube 58 is inserted from the tip of the tapered portion 63b of the sub-hub 61 and fixed to the tip side inside the sub-hub 61.

[0037] In addition, flanges 55c, 63c are formed at the base ends of the main hub 51 and the sub-hub 61, protruding radially outward and running around the side circumferential surfaces. The flanges 55c, 63c are capable of hooking the connector of a medical device of a predetermined standard. Furthermore, the inner circumferential surfaces of the main space 52 and the sub-space 62 may be formed with luer tapers 51a, 61a so as to be able to fit with a medical device having a male connector. Furthermore, the main space 52 of the main hub 51 and the sub-space 62 of the sub-hub 61 may house a hemostatic valve (not shown) for preventing backflow of blood, and a plug (not shown) for penetrating the hemostatic valve when the connector 60 of the infusion tube is inserted to allow infusion.

[0038] The catheter 40 and catheter hub 50 described above are initially housed in the accommodation space 24 of the housing 21, and their movement is controlled by a catheter operation unit 70 housed so as to cover the upper surface of the accommodation space 24. In particular, the catheter assembly 10A according to this reference example has the main hub 51 and sub-hub 61 both housed in the housing 21 and the catheter operation unit 70, making them operable as a unit.

[0039] Specifically, the catheter operation section 70 has an operation plate section 71 extending in the longitudinal direction of the housing 21, and a hub storage section 72 connected to the base end of the operation plate section 71 and for storing the catheter hub 50.

[0040] The operation plate 71 is a portion where the user's fingers are placed to perform the forward and backward operation. In the initial state, a pair of side edges 71a of the operation plate 71 are disposed on a pair of rail portions 23a of the housing 21 and on the upper surfaces of a pair of side walls 23. In addition, one or more catheter holding portions 73 each consisting of a pair of protrusions are provided along the longitudinal direction on the lower surface of the operation plate 71, and each portion holds the catheter 40 (see also FIG. 4A). In other words, the multi-structure needle 11 (catheter 40) is supported at a midpoint in the axial direction by the support member 27 and the operation plate 71. In addition, a plurality of ribs 74 and a plurality of operation tabs 75 are provided on the upper surface of the operation plate 71.

[0041] The hub storage section 72 has an upper section 76 and a pair of side sections 77 that are connected to both widthwise sides of the upper section 76 and extend downward, and is formed into a long box shape along the longitudinal direction of the catheter operating section 70. An internal space 78 that houses the main hub 51 and the sub-hub 61 is formed inside the upper section 76 and the pair of side sections 77. The internal space 78 is open to the lower surface and base end of the hub storage section 72.

[0042] The upper portion 76 of the hub storage section 72 is formed flat in the illustrated example, but may be formed into various shapes capable of housing the main hub 51 and the sub-hub 61. For example, the upper portion 76 may be formed into a dome shape. The tip sides of the pair of side portions 77 are formed into inclined portions 77a that gradually narrow toward the tip. The tip of the hub storage section 72 formed between the pair of inclined portions 77a has an opening (not shown) that allows the multi-structure needle 11 (catheter 40) to extend from the internal space 78.

[0043] Here, in the hub storage section 72 according to this reference example, the main hub 51 and the sub-hub 61 are arranged to be shifted in the longitudinal direction (extension direction of the inner needle 12), and further, the axis of the sub-hub 61 is arranged to be shifted radially outward (widthwise) with respect to the axis of the main hub 51. Specifically, the main hub 51 is arranged in the widthwise center of the hub storage section 72. As a result, the main hub 51 is also located in the widthwise center with respect to the housing 21, and the inner needle 12 is inserted through the main space section 52 and the main lumen 42 so as to extend linearly.

[0044] On the other hand, the sub-hub 61 is located on the proximal side of the main hub 51 and is disposed beside the inner needle 12. That is, the sub-hub 61 is disposed between the side wall 23 of the housing 21 and the inner needle 12, and moves in sliding contact with the inner needle 12 when moving. Note that, in the hub storage section 72 in Fig. 1, the sub-hub 61 is disposed on the proximal side of the entire main hub 51, but the proximal side of the main hub 51 and the tip side (tapered portion 63b) of the sub-hub 61 may be disposed so as to overlap in the width direction.

[0045] The relay tube 58 is housed in an appropriate form in a gap in the internal space 78 of the hub storage section 72, laterally of the main hub 51 and distal side of the sub-hub 61. For example, the relay tube 58 is folded back and bundled multiple times so that the tube lumen 59 is not crushed or kinked. The inner surface of the hub storage section 72 may be provided with a tube locking section (not shown) that locks the relay tube 58 with a weak force.

[0046] That is, in the initial state, the catheter assembly 10A constitutes a limiting section 100A that limits the free displacement of the sub-hub 61 by the hub storage section 72 of the catheter operating section 70. In this reference example, the housing 21 also covers the underside of the sub-hub 61 in the initial state, and therefore constitutes part of the limiting section 100A.

[0047] The catheter operating section 70 moves the main hub 51 and the sub-hub 61 together as a unit with the distal or proximal movement relative to the housing 21. For this reason, a locking portion 79 is provided on the inside of the hub storage section 72. In this reference example, the locking portion 79 includes a first locking portion 79a that locks the main hub 51 and a second locking portion 79b that locks the sub-hub 61.

[0048] The configuration of the first locking portion 79a is not particularly limited, and it is sufficient that it locks at an appropriate location depending on the outer shape of the main hub 51. For example, the first locking portion 79a may be composed of a mating piece that appropriately locks the tapered portion 55b of the main hub 51, and a piece that presses the base end of the main hub 51. Similarly, the configuration of the second locking portion 79b is not particularly limited, and it is sufficient that it locks at an appropriate location depending on the outer shape of the sub-hub 61. In addition, the hub storage portion 72 has an open base end side of the internal space 78, and the safety mechanism 90 is detachably connected thereto.

[0049] The safety mechanism 90 according to this reference example is formed in a cylindrical shape having a cavity 90a therein, and the inner needle 12 is penetrated in the initial state. The safety mechanism 90 accommodates the needle tip 13 that has moved as the inner needle 12 is released from the catheter 40, thereby preventing the needle tip 13 from being re-exposed. As shown in FIG. 2, the safety mechanism 90 accommodates a shutter member 91 and a retaining member 92 at a predetermined position in the cavity 90a. The shutter member 91 is elastically deformed in contact with the outer circumferential surface of the inner needle 12 in the penetrated arrangement state of the inner needle 12, and elastically restores to its original state when the needle tip 13 is removed, thereby blocking the penetration path of the inner needle 12. The retaining member 92 has a hole with a smaller diameter than the needle tip 13 of the inner needle 12, thereby restricting the needle tip 13 from being removed in the proximal direction.

[0050] The safety mechanism 90 also has a pair of claws 93 that protrude toward the tip. In the initial state, the pair of claws 93 are engaged with the catheter operating section 70. For example, the hub storage section 72 has inner convex portions (not shown) on the inner surfaces of a pair of side portions 77 that form the internal space 78, and the pair of claws 93 are caught on these inner convex portions. This allows the safety mechanism 90 to move integrally with the catheter operating section 70.

[0051] The base end sides of the pair of side portions 77 constituting the hub storage portion 72 may be configured as pieces (not shown) that are in a free state when exposed from the housing 21. The pair of pieces are arranged parallel to each other when stored in the housing 21 to engage the safety mechanism 90, and facilitate disengagement of the safety mechanism 90 when exposed.

[0052] The catheter assembly 10A according to this embodiment is basically constructed as described above, and its operation will be described below.

[0053] As described above, the catheter assembly 10A is used when constructing an inlet / outlet portion for infusion, blood transfusion, blood collection, etc., for a patient. A user grasps and operates the housing 21 of the catheter assembly 10A in the initial state to insert the multi-layered needle 11 into the patient. At this time, the catheter assembly 10A accommodates the relay tube 58 and the sub-hub 61 connected to the main hub 51 inside the housing 21 and the catheter operation section 70. That is, in the initial state, the free displacement of the sub-hub 61 relative to the main hub 51 is limited, so that the user can adequately grasp the housing 21 and easily perform subsequent operations without being affected by the sub-hub 61.

[0054] When the multi-structure needle 11 is inserted, the support member 27 of the housing 21 supports the catheter 40, ensuring good linearity of the catheter 40. When the catheter 40 is inserted, the tip inner circumferential surface 44a including the soft tip 47 is in close contact with the inner needle 12 and does not bend radially inward, which allows the catheter 40 to be easily inserted into the body.

[0055] When the needle tip 13 of the inner needle 12 reaches a blood vessel, blood that has flowed into the hollow portion 14 from the tip opening 14a of the inner needle 12 flows through the hole portion 14b into the main lumen 42 of the catheter 40. This allows the user to visually confirm the blood flashback and confirm that the main lumen 42 has secured the blood vessel.

[0056] In this puncture state, the user advances the catheter operating unit 70, and advances the catheter 40 relative to the inner needle 12, as shown in Fig. 4A. At this time, the catheter operating unit 70 advances the main hub 51 and sub-hub 61 stored in the hub storage unit 72, following them, and also moves the safety mechanism 90. When the catheter 40 is advanced, the catheter assembly 10A is able to suppress bending of the catheter 40 by supporting the underside of the catheter 40 with the support member 27.

[0057] In Fig. 4A, the operation plate 71 of the catheter operation unit 70 is shown in a flat extended state, but when the operation plate 71 advances, it curves due to the user's grip or contact with the patient's skin. At this time, the catheter holding portion 73 arranged on the underside of the operation plate 71 releases the hold of the catheter 40. Then, at the stage where the catheter 40 has been inserted to a certain extent into the blood vessel, blood begins to flow into the sub-lumen 43 from the side opening 43a. This allows the user to clearly recognize that the sub-lumen 43 has secured the blood vessel.

[0058] When the catheter operating section 70 is advanced to a certain extent relative to the housing 21, the tip of the hub housing section 72 comes into contact with the support member 27, causing the support member 27 to rotate outward. This makes it possible for the hub housing section 72 to be delivered to the tip side of the housing 21. When the catheter operating section 70 is advanced further, the hub housing section 72, which accommodates the main hub 51 and sub-hub 61, and the safety mechanism 90 are exposed to the outside of the housing 21, as shown in Fig. 4B.

[0059] When the safety mechanism 90 moves to the needle tip 13 of the inner needle 12, the actions of the shutter member 91 and the stopper member 92 described above block exposure of the needle tip 13 and prevent it from coming off the inner needle 12. In other words, the safety mechanism 90 engages with the inner needle 12 and the housing 21, and as shown in Fig. 5A, the hooking of the claw portion 93 is released, and the catheter operating section 70 is separated from the safety mechanism 90.

[0060] 5B, when the inner needle 12 is detached from the main hub 51, the main hub 51 and the sub-hub 61 can be removed from below (the open portion of the internal space 78) the hub storage section 72 of the catheter manipulation section 70. As described above, the first and second locking sections 79a, 79b of the hub storage section 72 weakly lock the main hub 51 and the sub-hub 61, so that the catheter 40, main hub 51, and sub-hub 61 can be easily separated from each other by, for example, pulling the catheter manipulation section 70 upward relative to the catheter 40.

[0061] When the catheter 40 is placed, the medical devices to be connected are connected to the main hub 51 and the sub-hub 61, respectively. As a result, the catheter 40 administers a first medicinal liquid to the patient via the main space portion 52 and the main lumen 42, and administers a second medicinal liquid to the patient via the sub-space portion 62, the tube lumen 59, the sub-flow path 53, and the sub-lumen 43.

[0062] The catheter assembly 10A may not be provided with the safety mechanism 90, or may have another structure in addition to the above-mentioned structure that assists in the insertion operation of the catheter 40. The other mechanism may include a guidewire that assists in the insertion of the catheter 40, and a guidewire operating member that operates the advancement and retraction of the guidewire.

[0063] Alternatively, the safety mechanism 90 is not limited to the above-mentioned configuration, and various mechanisms capable of preventing erroneous sticking of the inner needle 12 may be employed. For example, the catheter assembly 10A may be configured such that a blunt needle (rod member) is housed in the hollow portion 14 of the inner needle 12, and the blunt needle is exposed as the catheter 40 is advanced. The catheter assembly 10A may also be configured such that multiple telescope-type cylinders are extended as the catheter 40 is advanced, to house the entire inner needle 12.

[0064] Furthermore, in the above-mentioned reference example, the catheter 40 has two lumens 41, but in the present invention, the catheter 40 may have one lumen 41, or three or more lumen 41. Even if the catheter 40 has one lumen 41, it is possible to adopt a configuration in which a connector 60 is connected to the catheter hub 50 and a medicinal liquid is caused to flow from the connector 60 to the lumen 41 of the catheter 40. Even in this configuration, by applying the limiting section 100A, the free displacement of the connector 60 relative to the catheter 40 can be limited, greatly improving usability.

[0065] In addition, the catheter assembly 10A may be freely arranged with respect to the arrangement of the main hub 51 and the sub-hub 61 housed inside the housing 21 and the catheter operation unit 70. For example, as in a first configuration example shown in FIG. 6A, the main hub 51 and the sub-hub 61 may be arranged so as to be aligned in the width direction inside the housing 21 and the catheter operation unit 70. Even if the main hub 51 and the sub-hub 61 are aligned in the width direction in this way, the housing 21 and the catheter operation unit 70 can be made short in the vertical direction. Therefore, the user can smoothly perform the puncture operation of the multi-layered needle 11 and the insertion operation of the catheter 40 by holding the lower wall 22 of the housing 21 and the upper part 76 of the catheter operation unit 70 between his / her fingers.

[0066] 6B, the main hub 51 and the sub-hub 61 may be arranged so as to be aligned vertically (up and down) inside the housing 21 and the catheter operation section 70. In FIG. 6B, the main hub 51 is arranged on the upper side, and the sub-hub 61 is arranged on the lower side. When the main hub 51 and the sub-hub 61 are aligned vertically in this manner, the housing 21 can have a short dimension in the vertical direction. Therefore, by holding the pair of side walls 23 of the housing 21 between the fingers, the user can smoothly puncture the multi-structure needle 11 and insert the catheter 40.

[0067] 6C, the main hub 51 may be disposed on the lower side and the sub-hub 61 on the upper side. This causes the inner needle 12 to extend closer to the lower wall 22 of the housing 21, making it easier to insert the multi-structure needle 11 into a patient at a shallower angle.

[0068] [First Modification] As shown in Fig. 7A, the catheter assembly 10B according to the first modified example differs from the catheter assembly 10A described above in that two connectors 60 (a first sub-hub 64 and a second sub-hub 65) are connected to a catheter hub 50 (a main hub 51). In the following description, elements having the same configuration or function as those in the previously described reference example are denoted by the same reference symbols, and detailed description thereof will be omitted.

[0069] In this case, the catheter 40 can be configured to have three lumens 41 that communicate with the catheter hub 50, the first sub-hub 64, and the second sub-hub 65, respectively. Alternatively, the catheter 40 can have two lumens 41, with one lumen 41 communicating with the first sub-hub 64 and the other lumen 41 communicating with the second sub-hub 65. The first sub-hub 64 is connected to the main hub 51 via a first relay tube 58a, and the second sub-hub 65 is connected to the main hub 51 via a second relay tube 58b.

[0070] The housing 21 and the catheter operating section 70 are configured similarly to the catheter assembly 10A described above, with the main hub 51 and the first and second sub-hubs 64, 65 stored in a hub storage section 72 of the catheter operating section 70. In other words, the hub storage section 72 of the catheter operating section 70 (and the housing 21) functions as a limiting section 100B that limits the free displacement of the first and second sub-hubs 64, 65.

[0071] For example, the main hub 51 is disposed at the widthwise center of the hub storage section 72, holds the base end of the catheter 40, and the inner needle 12 passes through the inside. The first and second sub-hubs 64, 65 are disposed relative to the main hub 51 on the distal side of the main hub 51, with the tapered direction of the tapered section 63b facing toward the proximal end. With this arrangement, the widthwise dimensions of the housing 21 and the catheter operating section 70 can be made as small as possible. Although not shown in the figure, the hub storage section 72 has a locking section 79 that locks the main hub 51 and the first and second sub-hubs 64, 65, respectively (or integrally).

[0072] Also, a clamp 110 is attached in advance to each of the first and second relay tubes 58a, 58b. As shown in Fig. 7B, the clamp 110 has a base 111 and a pair of arms 112 extending from the base 111, the pair of arms 112 being formed so as to be thick on the base 111 side and thin on the extended end side, and having a retaining protrusion 112a protruding inward at the extended end. In other words, the clamp 110 is configured to be able to transition between a non-occluding state in which the extended end side engages with the first and second relay tubes 58a, 58b in a non-occluding manner, and an occluding state in which the base 111 side engages with the tube lumen 59 in an occluding manner.

[0073] The hub storage section 72 may be configured to store the clamp 110 therein, as shown in the connected state of the first relay tube 58a in Fig. 7A, or may be configured to have a portion of the clamp 110 protrude from a window 76a provided in the upper portion 76, as shown in the connected state of the second relay tube 58b in Fig. 7A.

[0074] As described above, the catheter assembly 10B according to the first modified example also comprises a limiting section 100B in which the main hub 51 and the first and second sub-hubs 64, 65 are disposed inside the catheter operating section 70. This limits the free displacement of the first and second sub-hubs 64, 65, improving the handleability of the catheter assembly 10B.

[0075] [Second Modification] 8, the catheter assembly 10C according to the second modified example differs from the catheter assemblies 10A and 10B described above in that the sub-hub 61 connected to the main hub 51 is exposed from the catheter operating section 70. That is, the catheter operating section 70 has a notch 80 that is continuous between an upper section 76 and a side section 77, and the relay tube 58 that connects the main hub 51 and the sub-hub 61 is passed through the notch 80. Most of the relay tube 58 is stored in the hub storage section 72, and the portion exposed from the hub storage section 72 is only a short range (for example, 20% or less of the total length of the relay tube 58).

[0076] The inner needle 12 is inserted through the main hub 51 at the widthwise center of the hub storage section 72. The sub-hub 61 is exposed to an upper portion 76 of the catheter operating section 70, and is located slightly offset in the widthwise direction from the main hub 51. In addition, in the sub-hub 61, the tapered portion 63b tapers toward the base end at a position near the notch 80.

[0077] Even in the catheter assembly 10C in this manner in which a portion of the relay tube 58, the sub-hub 61, is exposed through the cutout 80, the relay tube 58 is caught by the catheter manipulation section 70 around the cutout 80, thereby restricting free displacement of the sub-hub 61 relative to the main hub 51. In other words, the catheter manipulation section 70 functions as the restricting section 100C of the present invention.

[0078] The catheter assembly 10C may also include a locking portion 81 (see two-dot chain line in FIG. 8) that appropriately locks the sub-hub 61 exposed at the upper portion 76 of the catheter operating section 70. This makes it possible to more reliably suppress swinging of the sub-hub 61. The catheter assembly 10C according to the second modified example may also have multiple sub-hubs 61 and relay tubes 58 connected to each sub-hub 61, as in the first modified example. Even in this case, by providing multiple cutouts 80, a configuration can be achieved in which a portion of each relay tube 58 and each sub-hub 61 are exposed.

[0079] [First embodiment] 9A and 9B, the catheter assembly 10D according to the first embodiment differs from the above-described catheter assemblies 10A to 10C in that the inner needle 12 is inserted through both the main hub 51 and the sub-hub 61. That is, the main hub 51 and the sub-hub 61 are initially housed in the hub housing section 72 of the catheter operating section 70 in a state where they are aligned along the axial direction of the inner needle 12.

[0080] In this case, the main hub 51 can have a configuration similar to that of the catheter assembly 10A described above (the relay tube 58 is connected to the side surface of the tapered portion 55b, and the sub-flow path 53 and the tube lumen 59 communicate with each other). On the other hand, in the sub-hub 61, the relay tube 58 is connected to the side surface of the tapered portion 63b, and a hole that communicates the tube lumen 59 and the sub-space portion 62 is formed in this side surface. The sub-hub 61 also has a valve body 66 that allows the inner needle 12 to be inserted into the tip side of the sub-space portion 62 and closes when the inner needle 12 is removed. The valve body 66 closes the sub-space portion 62 when the medical device is connected to the sub-hub 61 (when the inner needle 12 is removed), thereby allowing the medicinal liquid to flow smoothly through the tube lumen 59.

[0081] The hub storage section 72 of the catheter operating section 70 includes a first locking portion 79a that locks the side peripheral surface of the main hub 51 and a second locking portion 79b that locks the side peripheral surface of the sub-hub 61. This allows the main hub 51 and the sub-hub 61 to be moved based on the operation of the catheter operating section 70 by the user.

[0082] In the above-described catheter assembly 10D, the inner needle 12 inserted through the inside of the sub-hub 61 functions as a limiting section 100D that limits the free displacement of the sub-hub 61. The catheter operation section 70 also configures part of the limiting section 100D by housing the relay tube 58, and it is possible to prevent the relay tube 58 from getting in the way when performing the puncture operation of the multi-layered needle 11 or the insertion operation of the catheter 40.

[0083] Second Embodiment 10, a catheter assembly 10E according to the second embodiment has an inner needle 12 inserted through a main hub 51 and a sub-hub 61, as in the first embodiment, but differs from the above-described catheter assemblies 10A to 10D in that a connection mechanism 67 is provided for connection to the main hub 51. In addition, an upper portion 76 of the catheter operating section 70 (hub storage section 72) is provided with an upper opening 76b that exposes the main hub 51 and the sub-hub 61.

[0084] In this case, the connection mechanism 67 is composed of multiple connection arms 67a fixed to the sub-hub 61. A plurality of connection arms 67a are provided on the tip side of the connection point of the relay tube 58. Each connection arm 67a protrudes radially outward from the sub-hub 61, bends midway, and extends toward the tip. An inner claw portion that hooks onto the flange portion 55c of the main hub 51 is provided at the extending end portion toward the tip side of each connection arm 67a. This allows the sub-hub 61 to move smoothly as the main hub 51 moves forward and backward.

[0085] The catheter operating section 70 has a locking section 79 that locks the side peripheral surface of the main hub 51 with an appropriate locking force. This allows the main hub 51 exposed from the upper open section 76b to rotate relative to the inner needle 12 under the user's operation. Here, in the catheter assembly 10E, the inner needle 12 and the catheter 40 may stick together due to long-term storage, etc., but the user can eliminate this sticking by rotating the main hub 51 before puncturing.

[0086] As described above, in the catheter assembly 10E according to the second embodiment, the inner needle 12 also functions as the restriction section 100E. The catheter operation section 70 can move the sub-hub 61 following the main hub 51 under the operation of the user via the connection arm 67a.

[0087] Third Embodiment 11A, a catheter assembly 10F according to the third embodiment differs from the above-described catheter assemblies 10A to 10E in that a first sub-hub 64 and a second sub-hub 65 are arranged side by side on the proximal end side of a main hub 51, and an inner needle 12 is inserted through the inside of each hub. In this case, the first sub-hub 64 is connected to the main hub 51 by a connection arm 67a, and the second sub-hub 65 is connected to the first sub-hub 64 by a connection arm 67a. The safety mechanism 90 of the catheter assembly 10F also has a connection arm 94 similar to the connection arm 67a instead of the claw portion 93, and is connected to the second sub-hub 65.

[0088] In this way, the inner needle 12 also functions as the restriction section 100F by axially lining up the main hub 51, the first sub-hub 64, and the second sub-hub 65 and inserting the inner needle 12 through them. Also, the catheter manipulation section 70 can move any one of the hubs (for example, the main hub 51) by advancing it, causing the other hubs to follow and move.

[0089] [Fourth embodiment] 11B, the catheter assembly 10G according to the fourth embodiment differs from the above-described catheter assemblies 10A to 10F in that a safety mechanism 90 is disposed on the base end side of the sub-hub 61, and a connection arm 94 of the safety mechanism 90 is hooked onto the main hub 51. The inner needle 12 passes through the main hub 51, the sub-hub 61, and the safety mechanism 90, and thereby functions as a restriction section 100G of the present invention. Even if the safety mechanism 90 is connected to the main hub 51 in this manner, the main hub 51 moves the safety mechanism 90 in response to the operation of the catheter operation section 70, so that the safety mechanism 90 can push the sub-hub 61 to move the sub-hub 61.

[0090] Fifth embodiment A catheter assembly 10H according to the fifth embodiment differs from the above-mentioned catheter assemblies 10A to 10G in that, as shown in Fig. 11C, the tip of the sub-hub 61 is inserted into the main hub 51 and the two are fitted together. That is, the inner circumferential surface of the main hub 51 constituting the main space portion 52 is formed into a luer taper 51a, into which the tapered portion 63b of the sub-hub 61 can be fitted. In this catheter assembly 10H, the main hub 51 functions as a restriction portion 100H together with the inner needle 12. Then, the main hub 51 and the sub-hub 61 can be moved together by operating the catheter operating portion 70.

[0091] [Third Modification] 12, a catheter assembly 10I according to a third modified example differs from the above-mentioned catheter assemblies 10A to 10H in that the housing 30 (needle hub 20) can be separated into upper and lower parts, and the main hub 51 extends to the base end side beyond the catheter operating section 70. Like the above-mentioned catheter assembly 10A, the catheter 40 has one or two lumens 41 (main lumen 42, sub-lumen 43), and forms the inner needle 12 and the multi-structure needle 11 in the initial state.

[0092] Specifically, the housing 30 has an upper housing 31 and a lower housing 32, and in an initial state, the distal ends of the housing 30 are closed to each other. A slit 30a is formed between the upper housing 31 and the lower housing 32 along the longitudinal direction of the housing 30. The distal end of the lower housing 32 can be separated into a right distal end 32R and a left distal end 32L, and is configured to open in the left-right direction.

[0093] The tip of the upper housing 31 has a restricting portion 33 that restricts the right tip 32R and the left tip 32L from opening in the left-right direction in an initial state. The restricting portion 33 holds the left and right sides of the right tip 32R and the left tip 32L with a pair of plate portions 33a, and connects the upper sides of the pair of plate portions 33a with a bridge portion 33b.

[0094] A retaining groove (not shown) is formed in each of the right tip portion 32R and the left tip portion 32L. The right tip portion 32R and the left tip portion 32L constituting the two retaining grooves form a hole-shaped support portion that rubs against the catheter 40 when the catheter 40 advances relative to the inner needle 12. In the initial state of the catheter assembly 10I, a small gap is formed between the outer surface of the catheter 40 and the inner surface of the support portion.

[0095] The catheter operation section 70 has a central base 82 detachably connected to the base end of the main hub 51, and a pair of finger hooks 83 extending on both sides in the width direction from the central base 82. As shown in Figs. 13 and 14A, the central base 82 extends in the longitudinal direction of the housing 30, engages the main hub 51 at the tip side, and is connected to a safety mechanism 90 on the base end side of the main hub 51. A hinge 82a that can bend the catheter operation section 70 is formed at the boundary between the main hub 51 and the safety mechanism 90 of the central base 82. The pair of finger hooks 83 are inclined upward toward the outside in the width direction, and a plurality of projections (not shown) for preventing slipping are provided on the underside.

[0096] Furthermore, the catheter assembly 10I has a guidewire 120 and a guidewire operating member 122. The guidewire 120 is disposed in the hollow portion 14 of the inner needle 12, and in the initial state, its tip is in standby near the needle tip 13. The guidewire operating member 122 is connected to the base end of the guidewire 120 via an intermediate connector (not shown) disposed in the housing 30. When the guidewire operating member 122 is displaced in the tip direction relative to the upper housing 31, the operating force is transmitted to the guidewire 120, and the guidewire 120 is advanced from the tip opening 14a of the needle tip 13.

[0097] In the catheter assembly 10I, the sub-hub 61 is connected via a relay tube 58 to the main hub 51, through which the inner needle 12 is inserted and in which the catheter operating section 70 is formed. In the initial state, most of this sub-hub 61 is exposed from the slits 30a of the upper housing 31 and the lower housing 32. The sub-hub 61 is configured to move in conjunction with the main hub 51 when it moves under the operation of the catheter operating section 70.

[0098] Specifically, a structural portion 68 capable of hooking onto the edge of the housing 30 that defines the slit 30a is provided at the tip of the sub-hub 61. The structural portion 68 has a first disc portion 68a at its tip, and a second disc portion 68b at a position slightly away from the first disc portion 68a toward the base end. In the initial state, the edges of the upper housing 31 and the lower housing 32 that define the slit 30a fit into the gap between the first disc portion 68a and the second disc portion 68b. As a result, when the upper housing 31 and the lower housing 32 are close to each other, the sub-hub 61 moves along the slit 30a.

[0099] Moreover, the first circular disk portion 68a is configured to be able to receive a moving force from the flange portion 55c of the main hub 51 or the catheter operating section 70. For example, the catheter operating section 70 has an extension portion 82b extending from a central base portion 82 on the proximal end side of the pair of finger hooks 83 along the side circumferential surface of the main hub 51. This extension portion 82b is configured to appropriately lock the main hub 51 and to lock the periphery of the first circular disk portion 68a.

[0100] When using the catheter assembly 10I configured as above, a user inserts the multi-layered needle 11 (inner needle 12, catheter 40) into a patient. At this time, the sub-hub 61 connected to the relay tube 58 is sandwiched between the upper housing 31 and the lower housing 32, and free displacement is restricted. That is, in this catheter assembly 10I, the housing 30 (needle hub 20) functions as the restricting portion 100I.

[0101] With the multi-structure needle 11 in the punctured state, the user operates the guidewire operating member 122 in the distal direction to project the guidewire 120 from the distal end of the inner needle 12 and insert it into the blood vessel. Then, the user operates the catheter operating unit 70 in the distal direction to advance the catheter 40, the main hub 51, and the sub-hub 61. During this movement, the upper housing 31 is pushed upward by the catheter operating unit 70 and opens relative to the lower housing 32. With the upper housing 31 separated, the right distal end 32R and the left distal end 32L of the lower housing 32 can be further separated from each other in the left-right direction. As a result, the catheter operating unit 70 is allowed to separate from the housing 30 in the distal direction.

[0102] Then, the user pulls the housing 30 in the proximal direction relative to the catheter 40, main hub 51, etc., to remove the inner needle 12 from the main hub 51. The sub-hub 61 also transitions to a free state by being exposed from the housing 30. After removing the inner needle 12, the user releases the locked state between the catheter operating unit 70 and the main hub 51 and the sub-hub 61 by rotating the tip side of the catheter operating unit 70 (central base 82) upwardly about the hinge 82a, as shown in Fig. 14B. This causes the catheter 40, main hub 51, and sub-hub 61 to be placed on the patient side.

[0103] As described above, this catheter assembly 10I can also provide the same effects as the catheter assemblies 10A to 10H described above. That is, the housing 30 also functions as the restricting portion 100I, restricting the free displacement of the sub-hub 61, thereby improving usability. Furthermore, in the catheter assembly 10I, the sub-hub 61 protrudes outward in the lateral direction of the housing 30, so that the main hub 51 is essentially mainly housed within the housing 30. This allows the size of the housing 30 to be reduced, making it easier for the user to grasp and operate.

[0104] [Fourth Modification] 15A, a catheter assembly 10J according to the fourth modified example differs from the above-described catheter assemblies 10A to 10I in that a first sub-hub 64 and a second sub-hub 65 are connected to a main hub 51, and the first and second sub-hubs 64, 65 protrude outward in the width direction through a slit 30a in a housing 30. Furthermore, in the catheter assembly 10J, the first sub-hub 64 is configured similarly to the sub-hub 61 of the third modified example, while the second sub-hub 65 is directly connected to the side circumferential surface of the barrel 55a of the main hub 51.

[0105] In this way, the catheter assembly 10J can form a limiting section 100J in which the free displacement of the first sub-hub 64 is limited by the housing 30, and the free displacement of the second sub-hub 65 is limited by the main hub 51. Furthermore, the catheter operating section 70 can move the main hub 51 and the first and second sub-hubs 64, 65 together under the operation of the user.

[0106] [Fifth Modification] As shown in FIG. 15B, the catheter assembly 10K according to the fifth modified example has the sub-hub 61 exposed on the widthwise outer side of the housing 30, and one of the finger hooks 83 of the catheter operating section 70 is engaged with the sub-hub 61. In this case, the finger hook 83 is provided with a locking arm 84 that locks the sub-hub 61. For example, the locking arm 84 extends from the finger hook 83 in the proximal direction, and the extended end is formed into a C-shape in side view. A predetermined part of the sub-hub 61 is locked on the inside of the C-shape. Even when the catheter assembly 10K is configured in this way, the catheter operating section 70 functions as a limiting section 100K and can limit the free displacement of the sub-hub 61.

[0107] [Sixth Modification] As shown in Figures 16A to 17B, the catheter assembly 10L of the sixth modified example has a configuration in which the sub-hub 61 is exposed from the slit 30a of the housing 30, similar to the third modified example, but differs from the above-mentioned catheter assemblies 10A to 10K in that the restriction section 100L is formed by the catheter operating section 70.

[0108] The catheter operation section 70 has a locking section 79 for locking the main hub 51 at the tip of a central base 82, and a pair of finger hooks 83 protruding outward in the width direction at the longitudinal center of the central base 82. The central base 82 also has a hinge 82a at the boundary between the main hub 51 and the safety mechanism 90 on the proximal side, and is provided with a protruding wall 85 that protrudes downward (toward the gap between the main hub 51 and the safety mechanism 90) on the proximal side of the hinge 82a. The protruding wall 85 has a support plate 86 that extends toward the tip on one side in the width direction where the sub-hub 61 is disposed.

[0109] The support plate 86 extends parallel to the central base 82 on its lower side at a predetermined distance from the finger hook 83, and reaches the tip of the finger hook 83. The catheter operation unit 70 locks the sub-hub 61 by sandwiching the sub-hub 61 between the finger hook 83 and the support plate 86. The sub-hub 61 has a locked block 63d at the tip of the tapered portion 63b, and the relay tube 58 is connected to the side peripheral surface of the tapered portion 63b. The locked block 63d is configured to fit into locking grooves 83a, 86a provided on the lower surface of the finger hook 83 and the upper surface of the support plate 86, and the catheter operation unit 70 functions as a limiting unit 100L that limits the free displacement of the sub-hub 61.

[0110] In the catheter assembly 10L configured as above, as shown in Figures 16A and 16B, the rotation of the catheter manipulation section 70 is restricted within the housing 30, so that the sub-hub 61 (locked block 63d) is satisfactorily sandwiched between the finger hook 83 and the support plate 86. Then, as the catheter manipulation section 70 is advanced and exposed from the housing 30, it becomes possible to rotate the tip side of the central base 82 about the hinge 82a as a base point, as shown in Figures 17A and 17B. This causes the finger hook 83 to move away from the support plate 86, and the sub-hub 61 (locked block 63d) that was being sandwiched therebetween can be set in a free state.

[0111] [Seventh Modification] As shown in FIG. 18, the catheter assembly 10M according to the seventh modification is different from the catheter assemblies 10A to 10L in that the housing 30 is provided with a support plate 34, and the sub-hub 61 is sandwiched between the finger hook 83 of the catheter operation unit 70 and the support plate 34. In this case, a locking groove 83a that matches the outer shape of the sub-hub 61 is provided on the lower surface of the finger hook 83. Meanwhile, the support plate 34 of the housing 30 extends to the tip direction on one side wall of the lower housing 32. A guide groove 34a that is shaped to match the outer shape of the sub-hub 61 and extends to the tip direction is formed on the upper surface of the support plate 34. That is, the guide groove 34a has a function of guiding the sub-hub 61 when the sub-hub 61 moves in accordance with the movement of the finger hook 83. In this way, the catheter assembly 10M can also configure a limiting section 100M that limits the free displacement of the sub-hub 61 by making the housing 30 and the catheter operation unit 70 work together.

[0112] [Eighth Modification] 19A and 19B, a catheter assembly 10N according to the eighth modified example differs from the above-described catheter assemblies 10A to 10M in that a sub-hub 61 is provided with an inserted body 69 through which an inner needle 12 is inserted. Although not specifically shown, the catheter assembly 10N uses a housing 30 similar to that of the third modified example, and the sub-hub 61 is exposed to the outside in the width direction from a slit 30a.

[0113] The inserted body 69 has an insertion hole 69a in a direction perpendicular to the axial direction of the sub-hub 61, and in the initial state, the inner needle 12 is inserted through this insertion hole 69a. The insertion hole 69a does not communicate with a sub-space portion 62 in the sub-hub 61 which communicates with the tube lumen 59 of the relay tube 58. In other words, the catheter assembly 10N can cause the inner needle 12 to function as a limiting portion 100N that limits the free displacement of the sub-hub 61 even in a housing 30 having a slit 30a.

[0114] [Ninth Modification] 20A and 20B, a catheter assembly 10O according to a ninth modified example differs from the above-described catheter assemblies 10A to 10N in that it includes a clamp 130 that exposes the relay tube 58 and the sub-hub 61 from the housing 21 and the catheter operating section 70 and bundles the relay tube 58. That is, in this catheter assembly 10O, the limiting section 100O that limits the free displacement of the sub-hub 61 is formed by the clamp 130.

[0115] Specifically, clamp 130 is configured to engage relay tube 58 at multiple locations (two locations in FIG. 20B) and bundles relay tube 58 in a folded-back state. Clamp 130 is formed in a rectangular shape in a plan view, and is provided with a first engagement space 131 on one end side and a second engagement space 132 on the other end side.

[0116] The first engagement space 131 is configured by a pair of long arms 134 extending from a base 133 between the first engagement space 131 and the second engagement space 132. Each long arm 134 is formed thicker on the base 133 side and thinner on the extended end side, thereby configuring a first portion 131a that engages with the tube lumen 59 in an unblocked state and a second portion 131b that engages with the tube lumen 59 in an blocked state. One of the pair of long arms 134 is short, and the other is formed so as to go around the first portion 131a and wrap around to one side, and has an insertion gap 131c between the one and the other for inserting the relay tube 58.

[0117] On the other hand, the second engagement space 132 is formed by a pair of short arms 135 extending from the base 133 in the opposite direction to the long arm 134, and engages with the tube lumen 59 of the relay tube 58 in an unblocked state. The pair of short arms 135 are formed symmetrically, and form an insertion gap 132a in the portion protruding inward on the protruding end side. The pair of short arms 135 also have a thin portion 135a at the boundary with the base 133 that makes it easy to open the short arms 135 outward.

[0118] The clamp 130 configured in this manner engages the relay tube 58 at two appropriate points in a folded-back state, thereby shortening the distance from the notch 80 of the catheter operation section 70 to the sub-hub 61 and restricting (suppressing) the free displacement of the sub-hub 61 relative to the main hub 51. The clamp 130 also smoothly expands the short arm 135 at an appropriate timing under the user's operation. This allows the relay tube 58 to be easily removed from the second engagement space 132, allowing the relay tube 58 to be used in a long extended state.

[0119] [Tenth Modification] 21A to 21C, a catheter assembly 10P according to a tenth modification differs from the above-described catheter assemblies 10A to 10O in that it includes a support 35 that supports a sub-hub 61 in an initial state on the widthwise outer side of the housing 30. For example, the support 35 protrudes outward in the widthwise direction from the side wall 23 on the base end side of the housing 30, and protrudes toward the distal end via a bent portion along the way. The protruding end portion in the distal end direction is provided with a tapered protrusion 35a that can be fitted with an appropriate fitting force into the inner circumferential surface (luer taper) of the sub-hub 61 that constitutes the sub-space portion 62.

[0120] That is, as shown in Fig. 21A, in the initial state of the catheter assembly 10P, the sub-hub 61 and the support 35 (tapered protrusion 35a) are fitted together. The relay tube 58 connected to the sub-hub 61 is connected to the main hub 51 through the slit 30a of the housing 30. Then, as shown in Fig. 21B, when the catheter operating section 70 is advanced during insertion of the catheter 40, only the main hub 51 advances and is exposed from the tip of the housing 30. At this time, the sub-hub 61 continues to be supported by the support 35. When the main hub 51 is further pulled away toward the tip of the housing 30 in the exposed state, it is pulled by the relay tube 58 as shown in Fig. 21C. When this tensile force exceeds the fitting force, the sub-hub 61 comes out of the support 35 and becomes free, and is placed in the patient satisfactorily.

[0121] As described above, the catheter assembly 10P can limit the free displacement of the sub-hub 61 exposed from the housing 30 by making the support 35 provided on the side of the housing 30 function as a limiting portion 100P.

[0122] [Eleventh Modification] 22A, a catheter assembly 10Q according to an eleventh modified example differs from the above-described catheter assemblies 10A to 10P in that a sub-hub 61 is directly connected to the main hub 51. For example, the sub-hub 61 is connected in a direction perpendicular to the axial direction of the main hub 51 (the width direction of the housing 30), and protrudes from the accommodating space 24 of the housing 30 to the outside in the width direction of the housing 30 via the slit 30a.

[0123] In this catheter assembly 10Q, the main hub 51 and the sub-hub 61 are connected without the intermediate tube 58, and the main hub 51 serves as a limiting section 100Q that limits the free displacement of the sub-hub 61. In other words, in a configuration in which the main hub 51 and the sub-hub 61 are connected, the absence of the intermediate tube 58 makes it possible to hold the sub-hub 61 more firmly.

[0124] [Twelfth Modification] As shown in FIG. 22B, the catheter assembly 10R according to the twelfth modified example connects the main hub 51 and the sub-hub 61 without a relay tube 58, but differs from the above-mentioned catheter assemblies 10A to 10Q in that the sub-hub 61 is housed in the housing 30 (or the catheter operation section 70) together with the main hub 51. In this case, the limiting section 100R that limits the free displacement of the sub-hub 61 is the main hub 51. The sub-hub 61 is provided at an incline in the axial direction of the main hub 51, which allows the widths of the housing 30 and the catheter operation section 70 to be reduced. Since the catheter assembly 10R houses the sub-hub 61 in the housing 30, it is possible to prevent the user from contacting the sub-hub 61 during operation.

[0125] The technical ideas and effects that can be understood from the above-mentioned configuration will be described below.

[0126] The catheter assemblies 10A to 10R include a connector 60 configured to be connectable to a medical device, and also have limiting sections 100A to 100R that limit free displacement of the connector 60 relative to the catheter hub 50. This prevents the connector 60 from interfering with the user's operations when the inner needle 12 and the catheter 40 are inserted into the body, or when the catheter 40 is inserted into the body. In other words, even when the catheter assemblies 10A to 10R have a configuration in which the connector 60 is connected to the catheter hub 50, the usability can be significantly improved.

[0127] Furthermore, the limiting portions 100A to 100C, 100I to 100M are provided on the catheter operating section 70. This makes it possible for the catheter assemblies 10A to 10C, 10I to 10M to move the connector 60 in conjunction with the movement of the catheter operating section 70. This further improves the usability of the catheter assemblies 10A to 10C, 10I to 10M.

[0128] Furthermore, the needle hub 20 is configured as a housing 21 that accommodates the catheter hub 50 therein in an initial state, and the catheter operating section 70 accommodates the connector 60 movably inside the housing 21. By accommodating the connector 60 in this manner using the housing 21 and the catheter operating section 70, the catheter assemblies 10A to 10C can more reliably restrict the free displacement of the connector 60.

[0129] Furthermore, the axis of the connector 60 is accommodated in the housing 21 in a state where it is shifted radially outward with respect to the axis of the catheter hub 50. As a result, the catheter assemblies 10A, 10B are configured so that the inner needle 12 is not inserted into the connector 60, while preventing free displacement of the connector 60.

[0130] Furthermore, the connector 60 is accommodated within the housing 21 in a state where it is offset toward the distal end or proximal end with respect to the catheter hub 50. This allows the catheter assemblies 10A, 10B to have the connector 60 as close as possible to the axis of the catheter hub 50, and even in a configuration in which the connector 60 is accommodated within the housing 21, the size of the housing 21 can be reduced.

[0131] Also, the connector 60 may be connected to the catheter hub 50 via the relay tube 58 and exposed to the outside of the catheter operation section 70, which may have a cutout 80 through which the relay tube 58 can pass and into which the relay tube 58 can be hooked. In this way, the catheter assembly 10C can limit the free displacement of the connector 60 exposed to the outside by the relay tube 58 being hooked into the cutout 80 of the catheter operation section 70.

[0132] Alternatively, the needle hub 20 may be configured as a housing 30 that accommodates the catheter hub 50 and a portion of the catheter operating section 70 inside in the initial state and has a slit 30a that exposes a portion of the catheter operating section 70 to the side, and the connector 60 may be exposed to the outside of the housing 30 from the slit 30a and releasably engaged with the catheter operating section 70. In this way, even when the catheter assemblies 10I to 10M are configured such that the connector 60 is exposed to the outside from the slit 30a of the housing 30, the catheter operating section 70 can restrict free displacement of the connector 60.

[0133] Furthermore, the connector 60 may have a structural portion 68 that can be hooked onto the edge of the housing 30 that constitutes the slit 30a. In this manner, in addition to the configuration of the restriction section 100I by the catheter operating section 70, the catheter assembly 10I can more reliably restrict the free displacement of the connector 60 by the structural portion 68 of the connector 60 being hooked onto the edge of the housing 30.

[0134] The catheter manipulation unit 70 may be configured to pinch the connector 60 housed in the housing 30 and release the pinched connector 60 as the catheter manipulation unit 70 transitions to a state where it is exposed from the housing 30. This allows the catheter manipulation unit 70 to hold the connector 60 more reliably and effectively restrict the free displacement of the connector 60.

[0135] In addition, it is preferable that the catheter manipulation unit 70 sandwiches the connector 60 between itself and the housing 30, and the sandwiching of the connector 60 is released as the catheter manipulation unit 70 transitions to a state where it is exposed from the housing 30. In this manner, the catheter assembly 10M can limit the free displacement of the connector 60 by sandwiching the connector 60 between the catheter manipulation unit 70 and the housing 30.

[0136] Furthermore, the restricting portions 100D-100H, 100N can be configured to function when the connector 60 is inserted into the inner needle 12. The catheter assemblies 10D-10H, 10N can reliably restrict the free displacement of the connector 60 by the inner needle 12 functioning as the restricting portions 100D-100H, 100N.

[0137] Additionally, the connector 60 may be disposed within the needle hub 20 in a state aligned in the axial direction of the catheter hub 50. In the catheter assemblies 10D to 10H, the catheter hub 50 and the connector 60 are arranged aligned in the axial direction, thereby enabling the size of the needle hub 20 to be significantly reduced, making it easier for the user to grasp and operate.

[0138] Furthermore, the connector 60 is provided with a valve body 66 on the tip side of the space (subspace portion 62) within the connector 60, and the valve body 66 allows the inner needle 12 to be inserted therethrough and closes when the inner needle 12 is detached. By providing the valve body 66, the connector 60 can close the space within the connector 60 when the inner needle 12 is detached, thereby reliably preventing leakage of fluids such as medicinal solutions. This enables the catheter assemblies 10D to 10H to smoothly guide fluids into the catheter 40 through the connector 60.

[0139] Moreover, the connector 60 preferably has a connection mechanism 67 that connects so as to follow the movement of the catheter hub 50. In the catheter assemblies 10E to 10H, the connection mechanism 67 allows the catheter 40 and the connector 60 to move integrally.

[0140] Furthermore, the restricting portions 100I, 100J, 100M, and 100P may be provided on the needle hub 20. The catheter assemblies 10I, 10J, 10M, and 10P can also effectively restrict the free displacement of the connector 60 by providing the restricting portions 100I, 100J, 100M, and 100P on the needle hub 20.

[0141] Furthermore, the connector 60 is connected to the catheter hub 50 via a relay tube 58 and is exposed to the outside of the needle hub 20, and the needle hub 20 has a support 35 that fits into the connector 60 and supports the connector 60. Even in a configuration in which the connector 60 is supported by the support 35 of the needle hub 20, the catheter assembly 10P can suppress free displacement of the connector 60.

[0142] Furthermore, the connector 60 may be connected to the catheter hub 50 via the relay tube 58, and the restricting portion 100O may be a clamp 130 capable of holding the relay tube 58 in a bundled state. The catheter assembly 10O can also suppress free displacement of the connector 60 by holding the relay tube 58 in a bundled state with the clamp 130.

[0143] The restricting portion 100J, 100Q, 100R may also be configured by directly connecting the connector 60 to the catheter hub 50. This allows the catheter assemblies 10J, 10Q, 10R to more reliably suppress free displacement of the connector 60 relative to the catheter hub 50.

Claims

1. Inner needle and a needle hub fixed to a proximal end of the inner needle; a catheter having a first lumen through which the inner needle is inserted and a second lumen extending parallel to the first lumen; a catheter hub through which the inner needle is inserted and which is fixed to a base end of the catheter; a catheter operation unit that can operate the relative movement of the catheter and the catheter hub with respect to the inner needle; a support portion that supports the catheter when the catheter is moved; a connector connected to the catheter hub and capable of connecting other medical devices; a limiting portion that limits free displacement of the connector relative to the catheter hub via a relay tube; the restriction portion functions when the inner needle is inserted into the connector, The relay tube is connected to the outer periphery of the catheter hub and communicates with the second lumen. Catheter assembly.

2. The catheter assembly according to claim 1, The connector is disposed within the needle hub in axial alignment with the catheter hub. Catheter assembly.

3. An inner needle, a needle hub fixed to a proximal end of the inner needle; a catheter through which the inner needle is inserted; a catheter hub through which the inner needle is inserted and which is fixed to a base end of the catheter; a catheter operation unit that can operate the relative movement of the catheter and the catheter hub with respect to the inner needle; a support portion that supports the catheter when the catheter is moved; a connector connected to the catheter hub via a relay tube and capable of connecting other medical devices; the connector is a cylinder having a space, and is provided with a valve body at a tip side of the space inside the connector, the valve body is capable of inserting the inner needle therethrough and is closed when the inner needle is removed; The relay tube is connected to an outer periphery of the connector at a position closer to the base end than the valve body and communicates with the space. Catheter assembly.

4. The catheter assembly according to claim 1 or 2, The connector has a connection mechanism capable of connecting to the catheter hub in response to the movement of the catheter hub. Catheter assembly.

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