JP7549599B2 - Catheter Assembly - Google Patents

Description

The present invention relates to a catheter assembly having a safety member that prevents accidental sticking of the inner needle.

When forming an introduction portion for infusion or blood transfusion in a treatment subject (patient), a catheter assembly such as that disclosed in JP2013-529111A is used. This catheter assembly has a multi-tube with an inner needle inserted into a catheter (outer needle). When using this catheter assembly, a user inserts the multi-tube into the patient's body, then advances the catheter into a blood vessel, and then removes the inner needle from the catheter to leave the catheter in place.

In addition, the catheter assembly disclosed in JP2013-529111A has a catheter manipulation member for moving the catheter and catheter hub forward and backward, and a safety member that moves in response to the forward and backward movement of the catheter manipulation member and covers the tip of the inner needle, thereby activating a function to prevent accidental sticking of the inner needle.

Incidentally, a catheter assembly having a safety member as disclosed in JP2013-529111A is configured such that the safety member is engaged with the catheter hub or the catheter operating member, causing the safety member to follow and disengage when the puncture prevention function is activated. For this reason, the catheter assembly is prone to have a complex engagement structure between the catheter, catheter hub, inner needle, safety member, and catheter operating member, and the assembly work of each member is time-consuming.

The present invention relates to the above-mentioned catheter assembly technology, and aims to provide a catheter assembly that simplifies the assembly of each component and significantly improves work efficiency.

In order to achieve the above object, one aspect of the present invention is a catheter assembly comprising a catheter, a catheter hub that holds the catheter, an inner needle inserted into the catheter, a catheter operating member that allows a user to operate the movement of the catheter and the catheter hub, and a safety member that is inserted into and engages with the catheter hub so as to be movable together with the catheter hub and that advances beyond the tip of the inner needle that has punctured a treatment target to activate a function to prevent accidental puncture of the inner needle, wherein the catheter operating member has a tubular portion having an insertion space through which the safety member is inserted, and a slit extending in the axial direction of the tubular portion, and the slit allows the inner needle to pass from the side of the tubular portion into the insertion space while preventing the safety member from passing from the insertion space to the side of the tubular portion.

The above catheter assembly simplifies the assembly of each component, greatly improving work efficiency.

FIG. 1 is a perspective view of a catheter assembly according to an embodiment of the present invention. FIG. 2 is an exploded perspective view of the catheter assembly. 3A and 3B are a first and second operational views showing a procedure for using the catheter assembly, respectively; 4A and 4B are third and fourth operational views showing a procedure for using the catheter assembly, respectively. FIG. 2 is a side cross-sectional view of the catheter assembly. Fig. 6A is a perspective view from below of an inner needle hub supporting an inner needle, and Fig. 6B is a front view of the inner needle hub supporting an inner needle. Fig. 7A is a perspective view of the safety member as viewed from below, and Fig. 7B is a perspective view showing a state in which the cover body covers the inner needle. This is an oblique view from below of the catheter hub and the cover body with the catheter operating member assembled thereto. FIG. 2 is a perspective view of the upper grip as seen from below. FIG. FIG. 13 is an explanatory view illustrating the fixing of the inner needle hub and the lower grip. This is a cross-sectional view taken along line XII-XII in Figure 5. 13A and 13B are perspective views showing the lower grip and the support member in a pre-assembly state and in an assembled state, respectively. 13 is a partial cross-sectional side view showing a safety movement limiting mechanism that limits the movement of the cover body by a grip. FIG. 10 is a flowchart showing a procedure for assembling the catheter assembly. FIG. 11 is a first explanatory diagram showing an assembly procedure of the catheter assembly. FIG. 2 is a second explanatory diagram showing the assembly procedure of the catheter assembly. FIG. 3 is a third explanatory diagram showing the assembly procedure of the catheter assembly. Fig. 19A is a perspective view showing a disassembled state of a catheter assembly according to a modified example, and Fig. 19B is a cross-sectional view in a direction perpendicular to the longitudinal direction of the catheter assembly shown in Fig. 19A.

A preferred embodiment of the present invention will now be described in detail with reference to the accompanying drawings.

As shown in FIG. 1, a catheter assembly 10 according to one embodiment of the present invention is used when infusing fluids, transfusing blood, or collecting blood from a treatment target (living body), and a catheter 12 is inserted and placed in the body of the treatment target to establish electrical continuity between the inside and outside of the body. The catheter assembly 10 allows insertion of a catheter 12 (e.g., a central venous catheter, PICC, midline catheter, etc.) that is longer than a peripheral venous catheter. The catheter assembly 10 may also be configured to allow insertion of a peripheral venous catheter. The catheter assembly 10 is not limited to a venous catheter, and may also be one into which an arterial catheter such as a peripheral arterial catheter is inserted.

1 and 2, the catheter assembly 10, in a pre-use (pre-puncture) state, comprises an inner/outer needle assembly 16 assembled with a catheter 12, an inner needle 14, a catheter hub 20, an inner needle hub 30, a safety member 40, and a catheter operating member 60. The catheter assembly 10 further comprises a grip 18 (housing) that houses the inner/outer needle assembly 16 and is held by the user.

In the pre-puncture state, the inner and outer needle assembly 16 forms a multiple tube 11 in which the inner needle 14 penetrates the catheter 12 and the catheter hub 20 and the needle tip 15 of the inner needle 14 protrudes from the tip of the catheter 12. A safety member 40 through which the inner needle 14 is inserted is disposed on the proximal side of the catheter hub 20, and an inner needle hub 30 holding the inner needle 14 is disposed on the proximal side of the safety member 40. A catheter operating member 60 is disposed above the catheter 12, the catheter hub 20, and the safety member 40, allowing these members to advance and retreat. The inner and outer needle assembly 16 including the proximal portion of the multiple tube 11 is housed in the grip 18, and the inner needle hub 30 is fixed to the grip 18.

To facilitate understanding of the catheter assembly 10 according to this embodiment, the operation of the catheter assembly 10 during use will be described first. When in use, a user such as a doctor or nurse grasps the grip 18 of the catheter assembly 10 in the pre-puncture state shown in FIG. 3A and punctures the catheter 12 and the inner needle 14 into the blood vessel (vein or artery) of a patient (subject of treatment). While maintaining this puncture state, the user advances the catheter operating member 60 relative to the grip 18 (including the inner needle hub 30), thereby advancing the catheter 12 and the catheter hub 20. This causes the catheter 12 to advance deeper into the blood vessel. In addition, at the initial advancement of the catheter operating member 60, the safety member 40 also moves integrally with the movement of the catheter 12 and the catheter hub 20.

3B, the above-mentioned advancement operation causes the catheter 12 and catheter hub 20 to come out of the tip of the grip 18, and then the safety member 40 protrudes from the tip of the grip 18. When advancing the catheter manipulation member 60 (catheter 12, catheter hub 20), the user may perform an operation to retract the grip 18 relative to the catheter manipulation member 60. When the catheter manipulation member 60 is advanced further, the base end of the safety member 40 moves to the movement limit (advanced position) of the grip 18. At this time, the tip of the safety member 40 is exposed from the grip 18 and advances beyond the tip of the inner needle 14 to cover the inner needle 14, thereby activating the puncture prevention function.

When the safety member 40 is in the advanced position, it is locked in place and does not come out of the grip 18, stopping its movement toward the distal end and the proximal end. As a result, when the catheter 12, the catheter hub 20, and the catheter operating member 60 are advanced further, the safety member 40 disengages from these members.

4A, when the catheter operating member 60 and the safety member 40 are separated from each other, the catheter assembly 10 can disengage the catheter operating member 60 from the catheter hub 20. As a result, the catheter 12 and the catheter hub 20 are released from below the catheter operating member 60.

As shown in Figure 4B, the catheter 12 and catheter hub 20 are detached from the catheter operating member 60 and placed in the treatment subject. Before placement, the valve member 22 of the catheter hub 20 is removed and a connector (not shown) of another medical device is connected. Meanwhile, the inner needle 14, inner needle hub 30, safety member 40 and grip 18 are appropriately discarded by the user while remaining integrated. Below, each component of the catheter assembly 10 that performs the above operations will be specifically described.

As shown in Figures 1, 2 and 5, the catheter 12 of the catheter assembly 10 is configured as a tube having appropriate flexibility. An inner lumen 12a is provided inside the catheter 12, penetrating in the direction of arrow A (axial direction). The inner lumen 12a is set to a diameter capable of accommodating the inner needle 14 and allowing the flow of medicinal fluids, blood, etc. The length of the catheter 12 can be designed appropriately depending on the application and various conditions, and is set, for example, to approximately 14 to 500 mm, preferably within the range of 30 to 400 mm, and more preferably within the range of 76 to 200 mm.

The catheter 12 is preferably made of a soft resin material, such as fluororesins such as polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and perfluoroalkoxy fluororesin (PFA), olefin resins such as polyethylene and polypropylene, or mixtures of these, polyurethane, polyester, polyamide, polyether nylon resin, and mixtures of olefin resins and ethylene-vinyl acetate copolymer.

A coating material 13 that reduces the insertion resistance (piercing resistance) of the catheter 12 to the treatment target is applied to the outer peripheral surface of the catheter 12. For example, the coating material 13 is preferably applied to the entire circumferential direction of the catheter 12 and to at least 2/3 of the total length of the catheter 12 from the tip of the catheter 12 toward the base end (arrow A2 side). The coating material 13 is also applied to the needle tip 15 of the inner needle 14 exposed from the tip of the catheter 12. The coating material 13 may also be applied to the inner peripheral surface that constitutes the lumen 12a of the catheter 12, or may be applied to the outer peripheral surface of the inner needle 14.

The material constituting the coating material 13 is not particularly limited as long as it is capable of increasing the lubricity of the catheter 12, and may be, for example, a material capable of reducing frictional resistance, such as silicone, maleic anhydride polymer, acrylic acid polymer, or sulfobetaine polymer. The catheter assembly 10 may also be made of a material that enhances hydrophilicity, water repellency, antibacterial properties, or antithrombotic properties as the coating material 13.

The base end of the catheter 12 is fixed to the tip end in the catheter hub 20 by an appropriate fixing means such as crimping, fusing, or adhesive. The catheter hub 20 is exposed on the skin of the subject with the catheter 12 inserted into the subject's blood vessel, and is left indwelling together with the catheter 12 by being attached with tape or the like.

The catheter hub 20 is formed in a cylindrical shape tapering toward the side of the arrow A1 (tip direction). A flange portion 21 that protrudes radially outward is connected to the outer peripheral surface of the base end side of the catheter hub 20. The flange portion 21 has a spiral shape to which other medical devices can be screwed. An internal space 20a is provided inside the catheter hub 20, which communicates with the lumen 12a of the catheter 12 and through which medicinal fluids and blood can flow. The base end of the internal space 20a communicates with the base end opening 20a1 of the catheter hub 20.

The material from which the catheter hub 20 is made is not particularly limited, but examples of suitable materials include thermoplastic resins such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer.

A valve member 22 is inserted into the catheter hub 20 from the base end opening 20a1 toward the back side (arrow A1 side) of the internal space 20a. The valve member 22 has an insertion portion 23 that is inserted into the catheter hub 20 and an exposed portion 24 that is exposed from the catheter hub 20. The entire insertion portion 23 is made of an elastic material and is formed in a tapered shape that tapers toward the arrow A1 side. The outer peripheral surface of the insertion portion 23 is capable of surface contact with the inner peripheral surface of the catheter hub 20.

The exposed portion 24 is formed in a disk shape having an elastic portion 24a that is connected to the base end of the insertion portion 23 and is integrally molded with the insertion portion 23, and a hard portion 24b that annularly covers the outside of the elastic portion 24a. When the catheter hub 20 and the valve member 22 are assembled, the radially outer side of the exposed portion 24 protrudes to the same extent as the flange portion 21. A valve hole 25 that can be elastically opened and closed is provided at the axis of the insertion portion 23 and the exposed portion 24. In the pre-puncture state, the tip of the inner needle 14 and the safety member 40 of the valve member 22 are inserted into the valve hole 25, and the inner surface of the valve hole 25 and the outer surface of the safety member 40 are in close contact with each other. As a result, the valve member 22 fits the catheter hub 20 and the safety member 40 together, and prevents blood leakage when the inner needle 14 is punctured.

On the other hand, the inner needle 14 of the catheter assembly 10 is configured as a hollow tube having enough rigidity to puncture the skin of a living body. A sharp needle tip 15 is formed at the tip of the inner needle 14. A hollow portion 14a is formed penetrating the inside of the inner needle 14 along the direction of arrow A, and this hollow portion 14a communicates with a tip opening 14a1 provided at the needle tip 15 and a base end opening 14a2 provided at the base end of the inner needle 14. In addition, a horizontal hole 14a3 is provided at a position slightly away from the needle tip 15 on the arrow A2 side, which communicates with the outside of the inner needle 14 and the hollow portion 14a.

Examples of materials constituting the inner needle 14 include metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, or hard resins, ceramics, etc. The inner needle 14 is firmly fixed to the inner needle hub 30 by an appropriate fixing means such as fusion, adhesion, or insert molding.

2, 5, 6A, and 6B, the inner needle hub 30 has a grip fixing portion 31 fixed to the grip 18, and a holding frame portion 32 that protrudes upward (toward the arrow C1) from the grip fixing portion 31 and directly holds the inner needle 14. The grip fixing portion 31 is formed in an arc-shaped cross section with a width that allows it to be inserted into the accommodation space 18a of the grip 18 and a central portion in the width direction recessed downward so as to fit along the bottom wall 91 of the grip 18. The underside of the grip fixing portion 31 is provided with a plurality of (three in this embodiment) fixing protrusions 34 that protrude slightly downward and form an attachment mechanism 33 between the grip 18 and the grip fixing portion 31.

The multiple fixing protrusions 34 include a pair of tip fixing protrusions 34a that are located at the tip side of the grip fixing part 31 in the direction of arrow A and lined up in the width direction, and a middle fixing protrusion 34b that is located in the middle of the grip fixing part 31 in the direction of arrow A. The pair of tip fixing protrusions 34a are formed in a substantially cubic block, while the middle fixing protrusion 34b is formed in a substantially rectangular block that is long in the direction of arrow A.

The holding frame 32 also has a tubular portion 35 on the tip side that extends a predetermined length in the direction of arrow A and secures the inner needle 14. The tubular portion 35 has a hole 35a at its axis into which the inner needle 14 is inserted. The holding frame 32 supports the tubular portion 35 via a number of frame plates 36 that protrude from the top surface of the grip fixing portion 31 and extend in the direction of arrow A. Each frame plate 36 floats the tubular portion 35, thereby forming a space in which the blunt needle hub 51 described below can slide. The portion of the holding frame 32 on the base end side of the tubular portion 35 forms a space that defines the sliding range of the blunt needle hub 51.

2, 5, 7A and 7B, the safety member 40 is inserted into and engaged with the catheter hub 20 (valve member 22) and is configured to follow the catheter hub 20 during the movement process. This safety member 40 includes a cover body 41 that covers the outside of the inner needle 14 as it advances, a blunt needle 50 that protrudes from the needle tip 15 of the inner needle 14 after puncture, and a blunt needle hub 51 that holds the blunt needle 50.

The cover body 41 has a tip cover part 42 located on the side of the arrow A1, a base end extension part 43 connected to the upper part of the tip cover part 42 and extending a predetermined length toward the side of the arrow A2, and a pair of protrusions 44 protruding outward in the width direction from the base end extension part 43. In addition, an engagement protrusion 45 with which the blunt needle hub 51 engages is provided on the arrow A1 side of the base end extension part 43 (the connection point of the tip cover part 42).

The tip cover part 42 is configured in a cylindrical shape with a protective space 42a that can accommodate the inner needle 14 formed therethrough. The tip cover part 42 is formed in a thin cylindrical shape at the tip side and in a cylindrical shape that is thicker at the base end side than the tip side. The outer peripheral surface of the tip side of the tip cover part 42 is frictionally fitted to the catheter hub 20 including the valve member 22 by being inserted into and closely attached to the valve member 22 in the pre-puncture state. In the pre-puncture state, the base end of the tip cover part 42 faces the tip of the holding frame part 32 of the inner needle hub 30. The cover body 41 is designed so that the needle tip 15 is located on the base end side of the most distal end of the tip cover part 42 in the advanced position where the movement of the cover body 41 is restricted by the grip 18.

The base end extension part 43 has a connecting part 43a that protrudes upward at the connecting point with the tip cover part 42, and a plate part 43b that extends from the connecting part 43a to the base end side and is formed to be slightly wider than the connecting part 43a. The connecting part 43a suspends the tip cover part 42, thereby determining its height (arrow C direction) position. The plate part 43b has a thickness that provides rigidity that does not deform the safety member 40 in the vertical or width directions. In the pre-puncture state, this plate part 43b extends along the upper part of the inner needle hub 30 (retaining frame part 32) to the base end inside the grip 18.

The pair of protrusions 44 are formed in a plate shape thinner than the base end extension 43, and extend from the middle of the base end extension 43 in the direction of arrow A to the base end. Each protrusion 44 protrudes outward in the width direction (direction of arrow B) beyond the inner needle hub 30 (grip fixing portion 31) and extends to a position near the side wall 77 of the grip 18 (see also FIG. 12). Each protrusion 44 constitutes a guide mechanism 46 that cooperates with the grip 18 to guide the movement of the safety member 40 in the direction of arrow A.

In addition, one of the pair of protruding portions 44 (the protruding portion 44 on the side of arrow B1) is provided with a guided protrusion 47 that protrudes toward the side of arrow C2 and extends along the direction of arrow A. The guided protrusion 47 constitutes part of the guide mechanism 46, and is positioned on the inside of the lower side wall 92 on the side of arrow B1 of the grip 18 (lower grip 90), thereby preventing the safety member 40 from shifting in the width direction.

Furthermore, the protrusion 44 on the arrow B1 side has an interlocking protrusion 48 on the arrow B1 side (outside in the width direction) of the guided protrusion 47 and on the arrow A2 side of the protrusion 44. The interlocking protrusion 48 is interlocked with the interlocking portion 109 of the grip 18 when the safety member 40 is in the advanced position, thereby forming one side of a safety movement limiting mechanism 49 that limits the advancement and retreat of the cover body 41. The interlocking protrusion 48 will be described in detail later.

The blunt needle 50 of the safety member 40 is a rod member (round bar) configured to prevent the inner needle 14 from puncturing the catheter 12 or the living body, and is movably housed in the hollow portion 14a of the inner needle 14. The tip of the blunt needle 50 is formed into a shape (e.g., a polished flat surface) that is blunter than the needle tip 15 of the inner needle 14, and is positioned near the base end of the horizontal hole 14a3 in the hollow portion 14a of the inner needle 14 before puncture.

That is, before puncture, the blunt needle 50 constitutes the multiple tube 11 together with the catheter 12 and the inner needle 14. Then, as the safety member 40 advances, the tip of the blunt needle 50 is exposed from the needle tip 15. The thickness of the blunt needle 50 is preferably slightly smaller than the diameter of the hollow portion 14a of the inner needle 14, and the outer diameter may be set, for example, in the range of about 0.19 mm to 1.19 mm. The material constituting the blunt needle 50 is not particularly limited as long as it has sufficient hardness, and examples of the material include metal materials such as stainless steel, superelastic alloys such as Ni-Ti alloys, shape memory alloys, cobalt alloys, precious metals such as gold and platinum, and tungsten alloys, or resin materials with a predetermined hardness or higher.

The blunt needle hub 51 fixes and holds the blunt needle 50, and is configured to be movable relative to the inner needle 14, the inner needle hub 30, and the grip 18 by engaging with the cover body 41. The blunt needle 50 advances and retreats in response to the advancement and retreat of the blunt needle hub 51. The blunt needle hub 51 has a blunt needle holding portion 52 that holds the blunt needle 50, and an arm portion 53 that extends from the base end of the blunt needle holding portion 52 toward the tip end.

The blunt needle holding portion 52 is configured in a block shape having a predetermined height in the vertical direction, and the base end side of the blunt needle 50 is fixed at its upper portion. In the pre-puncture state, the blunt needle holding portion 52 is disposed in a space on the base end side of the cylindrical portion 35 of the holding frame portion 32. Therefore, when the blunt needle hub 51 advances relative to the inner needle hub 30 and the tip surface of the blunt needle holding portion 52 contacts the base end surface of the cylindrical portion 35, further advancement of the blunt needle hub 51 is prevented.

The arm portion 53 extends a predetermined length from the blunt needle holding portion 52 toward the arrow A1 side, and the entire extension is configured to be elastically deformable in the width direction. The tip of the arm portion 53 is provided with an engagement portion 54 that engages with the engagement protrusion 45 of the cover body 41 in the pre-puncture state. The engagement portion 54 is composed of an inclined portion 55 located at the tip, and a hook portion 56 that protrudes further toward the arrow A1 side than the inclined portion 55 and clamps the engagement protrusion 45 between the inclined portion 55 and the hook portion 56.

The inclined portion 55 protrudes toward the arrow A1 side and the arrow B1 side (inward in the width direction). The engaging protrusion 45 of the cover body 41 is formed in a triangular shape along the inclination of the inclined portion 55 in a planar cross-sectional view, and is guided by the inclination of the inclined portion 55. The hook portion 56 includes a plate piece 56a protruding from the connection point of the inclined portion 55 toward the arrow A1 side, and a convex portion 56b that protrudes short from the tip of the plate piece 56a toward the arrow B1 side and surrounds (hooks) the engaging protrusion 45 between the inclined portion 55. When the movement of the blunt needle hub 51 is restricted (when the blunt needle holding portion 52 abuts against the cylindrical portion 35), the plate piece 56a of the hook portion 56 elastically deforms outward in the width direction when the cover body 41 advances, releasing the hook between the convex portion 56b and the engaging protrusion 45.

In addition, the safety member 40 is not limited to the above configuration as long as it can prevent accidental puncture by the needle tip 15 of the inner needle 14. For example, the safety member 40 may be composed of only the cover body 41 without including the blunt needle 50 or the blunt needle hub 51.

2, 5 and 8, the catheter operating member 60 is a member that advances and retreats the catheter 12, the catheter hub 20 and the safety member 40 based on the user's operation. The catheter operating member 60 has an operating plate portion 61 that extends in the longitudinal direction of the grip 18 (the direction of arrow A), a hub accommodating portion 62 that is connected to the base end of the operating plate portion 61 and accommodates the catheter hub 20, and an operating portion tube portion 63 that is connected to the base end of the hub accommodating portion 62 and accommodates the safety member 40.

The operation plate 61 is a portion where the user's finger is placed to perform the forward and backward operation. A plurality of tabs 64 are provided on the upper surface of the operation plate 61. The most distal tab 64a of the plurality of tabs 64 protrudes more than the other tabs 64, making it easier for the user's finger to push out the catheter operation member 60. In addition, the operation plate 61 is formed thin-walled, so that it has flexibility that allows it to bend in a direction away from the multiple tube 11. A pair of side edges 61a of the operation plate 61 are placed on a pair of rail walls 96, 98 of the grip 18, which will be described later, in the pre-puncture state. The material constituting the operation plate 61 (catheter operation member 60) is not particularly limited, and may be appropriately selected from the materials listed for the catheter hub 20, for example.

At the tip of the operation plate 61, a concave block 65 is provided that is curved toward the arrow C1 side as it approaches the arrow A1 side. A groove 65a is provided on the underside and in the center of the width of the concave block 65, in which the catheter 12 is placed in the puncture state. The width of the groove 65a is slightly wider than the outer diameter of the catheter 12. In addition, a number of ribs 66 that can come into contact with the catheter 12 are provided on the underside of the operation plate 61.

On the other hand, the hub accommodation portion 62 of the catheter manipulation member 60 has an accommodation chamber 62a inside for accommodating the catheter hub 20 including the valve member 22, and is formed in a box shape with the lower side of this accommodation chamber 62a open. The hub accommodation portion 62 is formed narrower than the side wall 77 of the grip 18, and the movement of the catheter manipulation member 60 is guided by the side wall 77. The tip surface of the hub accommodation portion 62 is provided with a gap 62b narrower than the diameter of the catheter hub 20 and allowing only the catheter 12 (multiple tube 11) to extend therethrough.

The operating part tube portion 63 is formed in a cylindrical shape that protrudes a predetermined length from the base end surface of the hub housing portion 62 toward the base end. An insertion space 63a that communicates with the housing chamber 62a of the hub housing portion 62 is provided inside the operating part tube portion 63. The insertion space 63a is formed to penetrate the operating part tube portion 63 in the axial direction, and the tip cover portion 42 of the safety member 40 (cover body 41) is inserted into the insertion space 63a. In addition, an arc-shaped rib 67 that protrudes in the circumferential direction and reinforces the operating part tube portion 63 is provided on the outer circumferential surface of the operating part tube portion 63.

The inner diameter of the insertion space 63a is set to be slightly larger than the outer diameter D of the safety member 40 (tip cover portion 42 of the cover body 41) and smaller than the outer diameters of the catheter hub 20 and the valve member 22. Therefore, the operating portion cylinder portion 63 is configured to have a marginal space 63a1 (see FIG. 12) relative to the outer diameter D of the inserted tip cover portion 42. This allows the safety member 40 to rotate freely around its axis relative to the catheter operating member 60.

The operating portion tubular portion 63 has a slit 63b formed over the entire axial length of the operating portion tubular portion 63. That is, the slit 63b communicates with the storage chamber 62a at the tip side and extends linearly to the very base end of the operating portion tubular portion 63. This slit 63b allows the inner needle 14 to pass from the side of the operating portion tubular portion 63 into the insertion space 63a, while preventing the tip cover portion 42 from passing from the insertion space 63a to the side of the operating portion tubular portion 63.

8 and 12, the width W of the slit 63b is set to a dimension larger than the outer diameter φ of the inner needle 14 having a circular cross section. On the other hand, the width W of the slit 63b is set to a dimension smaller than the outer diameter D of the tip cover part 42 having a circular cross section. Therefore, the dimensions of the outer diameter φ of the inner needle 14, the outer diameter D of the safety member 40 (the base end side of the tip cover part 42), and the width W of the slit 63b have a relationship of φ<W<D. The width W of the slit 63b may be formed slightly smaller than the outer diameter φ of the inner needle 14, and may be configured to elastically deform the operating part tube part 63 when the inner needle 14 is passed through the slit 63b.

5, the operating portion tubular portion 63 is configured to have a certain amount of length along the axial direction in order to suppress bending of the catheter operating member 60 relative to the safety member 40. In particular, the axial length L of the operating portion tubular portion 63 is preferably set to at least 1/3 of the axial length of the hub housing portion 62 that houses the catheter hub 20. This makes it possible to maintain good linearity between the catheter operating member 60 and the safety member 40 when the catheter operating member 60 is operated.

Returning to FIG. 1, the grip 18 of the catheter assembly 10 is formed to an appropriate thickness for easy holding by the user and extends a predetermined length along the direction of arrow A. A storage space 18a is formed within the grip 18, into which the catheter 12, catheter hub 20, safety member 40, and catheter operating member 60 can advance and retreat. The storage space 18a communicates with the tip open portion 18b of the grip 18, and allows the catheter 12, catheter hub 20, safety member 40, and catheter operating member 60 to be delivered. The grip 18 is constructed by assembling an upper grip 70 (first member) and a lower grip 90 (second member) that can be separated in the direction of arrow C (direction perpendicular to the longitudinal direction).

1, 2 and 9, the upper grip 70 has a ceiling wall 71, a pair of upper side walls 72 and an upper rear wall 73, and is formed in a downwardly open concave (bowl-like) shape. The ceiling wall 71 has a covering portion 71a whose upper portion is not exposed from the middle portion in the direction of arrow A to the base end. The covering portion 71a is formed in an arc shape in cross section. The lower surface (inner side) of the covering portion 71a is provided with a pair of protrusions 74 that protrude downward shorter than the pair of upper side walls 72 and extend in the direction of arrow A. The pair of protrusions 74 are located above the cover body 41 and close to the upper surface of the cover body 41 (the pair of protrusions 44), and form part of the guide mechanism 46 that guides the advancement and retreat of the cover body 41 (see also FIG. 12).

On the other hand, the ceiling wall 71 has an operation unit exposure notch 75 formed in the center in the direction of arrow B, closer to the tip than the intermediate portion, to form a pair of (bifurcated) extending portions 76. The pair of upper side walls 72 and the pair of protruding portions 74 extend from the base end of the covering portion 71a to approximately the tip of the pair of extending portions 76 (to the base end of the upper protruding piece portion 78 described below), reinforcing the pair of extending portions 76.

The pair of upper side walls 72 protrude downward from the sides of the ceiling wall 71, thereby constituting the side walls 77 of the grip 18 together with the lower side walls 92 of the lower grip 90. The upper side wall 72 on the side of arrow B1 accommodates the locked protrusions 48 of the cover body 41 inside in each pre-puncture state, making the locked protrusions 48 non-exposed. Additionally, a number of upper recesses 72a are formed on the tip side of each upper side wall 72 to guide the user's grip.

The operating portion exposure notch 75 of the upper grip 70 is formed between a pair of protrusions 74 and communicates with the accommodation space 18a. The operating portion exposure notch 75 exposes the tab 64 of the catheter operating member 60 so that it can advance and retreat. The operating portion exposure notch 75 opens at the tip, allowing the catheter operating member 60 (tab 64) to advance and detach from the grip 18.

The pair of extensions 76 extend from the covering portion 71a toward the arrow A1 side on both sides of the operation unit exposure cutout 75 so as to gradually lower. Upper protruding pieces 78 are formed at the respective tips of the pair of extensions 76, which are generally flat and protrude outward in the width direction beyond the pair of upper side walls 72. Tip fixing hooks 80, which are part of the fixing mechanism 79 of the upper grip 70 and the lower grip 90, are provided on the undersides of the pair of upper protruding pieces 78. The pair of tip fixing hooks 80 protrude downwards slightly and have claws at their protruding ends (lower ends) that protrude inward in the width direction.

In addition, a block protrusion 81 that protrudes downward to the same extent as the upper side wall 72 is formed on the underside of the upper protrusion 78 on the arrow B1 side (hereinafter referred to as the first upper protrusion 78a). The block protrusion 81 partially covers the widthwise outer side of the safety movement limiting mechanism part 49 (space part 110) of the lower grip 90 described later, and the locked protrusion 48 of the safety member 40 that has moved to the advanced position is generally not exposed. Furthermore, a positioning notch 82 is provided on the side surface of the first upper protrusion 78a on the arrow A1 side from the block protrusion 81. On the other hand, an upper bearing hole 83 for supporting the lower support member 120 described later is provided on the underside of the upper protrusion 78 on the arrow B2 side (hereinafter referred to as the second upper protrusion 78b). A positioning notch 82 is also provided on the side surface of the second upper protrusion 78b on the arrow B2 side.

The upper rear wall 73 of the upper grip 70 protrudes toward the arrow C2 side shorter than the pair of upper side walls 72, and a pair of protrusions 74 are connected to its tip surface. A base end fixing hook 84 constituting part of the fixing mechanism 79 is provided on the underside of this upper rear wall 73, and a fixing protrusion 85 is formed protruding in a position near the base end fixing hook 84 (on the arrow A2 side and the arrow B1 side). The base end fixing hook 84 protrudes downward by a short distance and has a claw at its protruding end (lower end) that protrudes toward the arrow A1 side.

2, 5, and 10, the lower grip 90 has a bottom wall 91, a pair of lower side walls 92, and a lower rear wall 93, and is formed into a concave shape (bowl-like) that is open upward. A predetermined range on the arrow A1 side of the bottom wall 91 is formed into an arc shape with the center in the width direction recessed downward, and serves as a guide surface 91a that guides the advancement and retreat of the catheter hub 20. A predetermined range on the arrow A2 side of the bottom wall 91 has the same shape as the guide surface 91a but is formed lower than the guide surface 91a, and serves as a mounting portion 91b on which the inner needle hub 30 is mounted.

11, the attachment portion 91b is provided with a plurality of attachment holes 94 (three in this embodiment) into which the fixing protrusions 34 of the inner needle hub 30 can be fitted. Specifically, the plurality of attachment holes 94 include a pair of tip attachment holes 94a aligned in the width direction on the tip side of the attachment portion 91b, and an intermediate attachment hole 94b provided at a position spaced a predetermined distance from the pair of tip attachment holes 94a in the base end direction. The pair of tip attachment holes 94a are formed in a rectangular shape that is slightly elongated in the direction of arrow B, and the intermediate attachment hole 94b is formed as an elongated hole that is elongated in the direction of arrow A.

That is, when the inner needle hub 30 and the lower grip 90 are attached, the inner needle hub 30 is moved toward the bottom wall 91 of the lower grip 90 (simply inserted into the side indicated by arrow C2). This causes the pair of tip fixing protrusions 34a to be inserted into the pair of tip mounting holes 94a, and the intermediate fixing protrusions 34b to be inserted into the intermediate mounting holes 94b, so that each fixing protrusion 34 and each mounting hole 94 are firmly fitted together.

2, 10, and 12, a pair of lower side walls 92 of the lower grip 90 protrude upward (toward arrow C1) from the side of the bottom wall 91 and extend over substantially the entire length in the direction of arrow A. A plurality of lower recesses 92a are formed on the tip side of each lower side wall 92, which are connected to the upper recesses 72a and serve to guide the user's grip.

The lower side wall 92 on the side of arrow B2 has a thick wall 95 at the bottom, while the upper and inner side (arrow B1 side) of the thick wall 95 has a rail wall 96 that is continuous with the thick wall 95. In other words, a step is formed at the upper part of the lower side wall 92 on the side of arrow B2, and the upper side wall 72 of the upper grip 70 is positioned in this step so as to be in close contact with the side of the rail wall 96 in the assembled state.

The lower side wall 92 on the arrow B1 side is configured with a thick wall 95 at the bottom, while the upper part of the thick wall 95 is configured with two steps. Specifically, the thick wall 95 is formed lowest on the arrow B1 side at the top end thereof, and has a short protruding protruding wall 97 on the inside (from the widthwise center to the arrow B2 side), and further has a rail wall 98 that protrudes short at the top end of the protruding wall 97 on the arrow B2 side. The height of the rail wall 98 on the arrow B1 side is the same as the height of the rail wall 96 on the arrow B2 side. The upper side wall 72 of the upper grip 70 is placed in the step portion configured by the thick wall 95 and the protruding wall 97 in the assembled state.

In the assembled state, the engaging protrusion 48 of the cover body 41 is positioned in the step portion formed by the protruding wall 97 and the rail wall 98. In other words, between the upper side wall 72 of the upper grip 70 and the rail wall 98, a guide space 99a for the engaging protrusion 48 (part of the safety guide space 99) is formed in which the engaging protrusion 48 can slide.

The guide mechanism 46 that guides the safety member 40 is composed of a pair of upper side walls 72 and a pair of protrusions 74 of the upper grip 70, and a pair of rail walls 96, 98 of the lower grip 90. In other words, when the upper grip 70 and the lower grip 90 are assembled, a safety guide space 99 that guides the protrusion 44 of the safety member 40 is formed between the pair of protrusions 74 and the rail walls 96, 98. When the guide mechanism 46 is constructed, the safety member 40 places the rail wall 98 on the arrow B1 side of the lower grip 90 in the gap between the guided protrusion 47 and the locked protrusion 48. As described above, the side edge 61a of the operation plate portion 61 of the catheter operation member 60 is placed on the pair of rail walls 96, 98, so that the catheter operation member 60 can also be guided forward and backward (in FIG. 12, the operation plate portion 61 is shown by a two-dot chain line). In other words, in this embodiment, the safety guide space 99 shares the operating member guide space 100 .

The safety guide space 99 is open at the top when the upper grip 70 is separated from the lower grip 90, and is closed when the upper grip 70 is fixed to the lower grip 90. Meanwhile, a pair of side edges 61a of the catheter operating member 60 are formed with a width narrower than the width of a pair of protrusions 44 of the safety member 40, and are disposed on a pair of rail walls 96, 98. Therefore, the operating member guide space 100 is set narrower than the safety guide space 99 by the lower support member 120 described below, and is open at the tip (tip open portion 18b) of the grip 18, allowing the catheter operating member 60 to be delivered.

13A and 13B, the tip of the lower grip 90 is provided with a pair of protrusions 101 that protrude outward in the width direction from a pair of lower side walls 92. The pair of protrusions 101 have a sufficient thickness in the direction of arrow C, and their upper surfaces are located slightly higher than the upper ends of the rail walls 96, 98. The pair of protrusions 101 constitute a fixing mechanism 79 that fixes the upper grip 70 and the lower grip 90, and a positioning mechanism 102 that positions the support member 120.

The protrusion 101 on the arrow B1 side (hereinafter referred to as the first protrusion 103) protrudes from the upper part of the lower side wall 92 in the direction of arrow B1. A first fixing hole 103a, which is part of the fixing mechanism 79, is formed through the first protrusion 103 in the thickness direction. During assembly, the tip fixing hook 80 of the first upper protrusion 78a is inserted into the first fixing hole 103a, so that the claw hooks onto the lower end surface of the protrusion 101. In addition, a positioning protrusion 104 that protrudes slightly upward is provided on the arrow B1 side of the first protrusion 103, and this positioning protrusion 104 is inserted into the positioning notch 82 of the first upper protrusion 78a.

The protrusion 101 on the arrow B2 side protrudes in the direction of arrow B2 above and below the lower side wall 92 (hereinafter, the arrow C1 side is referred to as the second protrusion upper block 105, and the arrow C2 side is referred to as the second protrusion lower block 106), and there is a movement space 107 between them in which the support member 120 can rotate and move. A bearing notch 105a that rotatably supports the support member 120 is provided at the tip side of the second protrusion upper block 105. In a plan view, the bearing notch 105a is formed in a U-shape that opens to the arrow B1 side, and communicates with the inner storage space 18a. The upper end of the bearing notch 105a is formed in a step shape with a larger diameter than the lower part, and a pair of small protrusions 123 of the support member 120 described below are arranged in this step part. In addition, a second fixing hole 105b, which is part of the fixing mechanism 79, is formed through the base end side of the second protrusion upper block 105 in the thickness direction, and further, on the arrow B2 side, a positioning protrusion 104 is provided which is inserted into the positioning notch 82 of the second upper protrusion portion 78b.

The second protrusion lower block 106 is provided in a range facing the tip side of the second protrusion upper block 105 to configure the positioning mechanism 102 of the support member 120. A lower bearing hole 108 that supports the support member 120 is provided on the upper surface of the second protrusion lower block 106.

The support member 120 is rotatably attached by the positioning mechanism 102 of the grip 18, and is a component that supports the catheter 12 (multiple tubes 11) extending below the catheter manipulation member 60 in the pre-puncture state. The support member 120 also rotates when the wall of the hub housing 62 comes into contact with the support member 120 as the catheter manipulation member 60 moves, allowing the catheter manipulation member 60 to be delivered from the housing space 18a.

The support member 120 has a shaft portion 121 extending in the direction of arrow C, and a support body portion 122 protruding in a direction perpendicular to the axis of the shaft portion 121. The upper portion of the shaft portion 121 is provided with a guide plane 121a continuing to the upper end of the rail wall 96, and a pair of small projections 123 having the guide plane 121a. In the pre-puncture state, the side edge 61a of the catheter manipulation member 60 comes close to the guide plane 121a, thereby restricting the rotation of the support member 120.

In plan view, the support body 122 is narrow near the connecting portion of the shaft 121 and becomes wider as it moves away from the connecting portion. The upper surface of the support body 122 is flat (parallel to the bottom wall 91) in the protruding direction from the shaft 121 and is inclined downward at the protruding end. An inclined protrusion 122a is formed along the upper surface on the base end side of the protruding end.

The support member 120 configured in this manner is inserted from above the lower grip 90 along the bearing notch 105a with the support body 122 facing the side of arrow B1. At this time, the vicinity of the connecting portion of the support body 122 passes through the open portion on the accommodation space 18a side of the bearing notch 105a, allowing the support member 120 to be smoothly inserted into the bearing notch 105a and the lower bearing hole 108. When the upper grip 70 and lower grip 90 are attached, the upper end of the shaft portion 121 supported by the lower grip 90 is positioned in the upper bearing hole 83 of the upper grip 70.

In the pre-puncture state, the side edge 61a of the catheter manipulation member 60 is on the guide plane 121a, restricting the rotation of the support body 122 and allowing it to stand by and support the catheter 12. As a result, the support body 122 supports the catheter 12 from below, suppressing bending of the catheter 12. When the catheter manipulation member 60 comes out of the grip 18, the side edge 61a of the support member 120 comes out of the guide plane 121a, allowing it to rotate, and allowing the catheter manipulation member 60 and the safety member 40 to be delivered.

14, the lower side wall 92 on the arrow B1 side of the lower grip 90 is provided with a locking portion 109, which is the other part of the safety movement limiting mechanism 49 that limits the movement of the safety member 40 (cover body 41). The locking portion 109 has a space 110 cut out from the upper side of the lower side wall 92, an advancement limiting portion 111 that faces the advancement direction of the locked convex portion 48, and a retraction limiting portion 112 that restricts the retraction of the locked convex portion 48. The space 110 is connected to the tip of the safety guide space 99.

The advancement limiting portion 111 protrudes from the upper side (arrow C1 side) of the space portion 110 toward the arrow A2 side, and is connected to the first protrusion 103 formed on the outer side in the width direction. The protruding end on the arrow A2 side of the advancement limiting portion 111 is formed as an advancement limiting surface 111a that limits the advancement of the locked protrusion 48. The advancement limiting surface 111a is configured flat along the arrow C direction.

The retreat limiting portion 112 has an elastic arm portion 113 extending inside the space portion 110 toward the arrow A2 side, and a return portion 114 that is bent back from the protruding end of the elastic arm portion 113 toward the arrow C1 side and the arrow A1 side. The elastic arm portion 113 is elastically deformable in the direction of the arrow C, and elastically deforms when the engaging convex portion 48 contacts the return portion 114 during the advancement, and elastically restores its original shape when the engaging convex portion 48 moves toward the arrow A1 side.

The return portion 114 protrudes to the same height as the upper end of the rail wall 98. The return portion 114 has a retreat limiting surface 114a on the inside of the return (opposite the advance limiting surface 111a) that is inclined toward the arrow A1 side toward the arrow C1 side. The locking portion 109 has an advance position of the locked protrusion 48 between the advance limiting surface 111a and the retreat limiting surface 114a.

The outer upper end of the return portion 114 is inclined toward the arrow A1 side toward the arrow C1 side to form a guide surface 114b that makes it easier for the locked protrusion 48 to get over. Furthermore, the return portion 114 is provided with a thin wall 114c that protrudes from the arrow B2 side of the retreat limiting surface 114a to the arrow A1 side. The thin wall 114c is located in the same widthwise position as the rail wall 98 on the arrow B1 side, and its inner surface guides the guided protrusion 47 of the cover body 41 and prevents the locked protrusion 48 from shifting toward the arrow B2 side.

Here, the engaging protrusion 48 of the safety member 40 protrudes slightly from the protruding portion 44 toward the arrow B1 side, and is formed in a three-dimensional shape having a tip surface 48a, an upper surface 48b, a lower surface 48c, and a base end surface 48d. The tip surface 48a is formed parallel to the direction of the arrow C, and the upper surface 48b is formed parallel to the direction of the arrow A. On the other hand, the lower surface 48c is inclined toward the arrow C2 side from the lower end of the tip surface 48a toward the arrow A2 side, and is a surface that is guided by the guide surface 114b of the return portion 114 when the engaging protrusion 48 overcomes the return portion 114. The base end surface 48d is inclined toward the arrow A2 side from the upper surface 48b toward the arrow C2 side, and faces the retreat limiting surface 114a in the same inclination direction when the engaging protrusion 48 moves to the advanced position. As a result, when a backward force is applied to the safety member 40, the base end surface 48d of the locked protrusion 48 and the backward movement limiting surface 114a actively engage with each other, restricting the backward movement of the safety member 40.

Returning to Figure 10, the lower rear wall 93 of the lower grip 90 protrudes further toward the arrow C1 side than the rail walls 96, 98, and has a base end flange 115 that protrudes toward the arrow A2 side. A third fixing hole 115a is formed through the base end flange 115 along the thickness direction. The third fixing hole 115a is formed long in the direction of arrow B, and allows the base end fixing hook 84 and the fixing protrusion 85 to be inserted together.

The catheter assembly 10 of this embodiment is basically configured as described above, and the assembly of this catheter assembly 10 will be described below.

The catheter assembly 10 is assembled by assembling each component in accordance with the procedure shown in Figure 15. In general, the internal/external needle assembly 16 is first assembled, and then the internal/external needle assembly 16 is placed in the lower grip 90, and the upper grip 70 is attached to the internal/external needle assembly 16 and the lower grip 90.

In assembling the inner and outer needle assembly 16, the safety member 40 is first assembled into the inner needle 14 (step S1). In this case, as shown in FIG. 16, a part in which the inner needle 14 and the inner needle hub 30 are fixed in advance, a part in which the blunt needle 50 and the blunt needle hub 51 are fixed in advance, and a cover body 41 are prepared. Then, the tip of the blunt needle 50 is inserted from the base end of the inner needle hub 30, and the blunt needle 50 is advanced along the hollow portion 14a of the inner needle 14. The arm portion 53 of the blunt needle hub 51 is guided to the tip side of the holding frame portion 32 through the space within the holding frame portion 32 of the inner needle hub 30, and the blunt needle holding portion 52 of the blunt needle hub 51 is positioned opposite the base end of the tubular portion 35 within the holding frame portion 32.

Then, the tip of the inner needle 14 is inserted from the base end of the tip cover part 42 (protective space 42a) of the cover body 41. The tip cover part 42 is tubular with a thick base end and the protective space 42a is also wide, allowing the needle tip 15 of the inner needle 14 to easily enter. The cover body 41 is moved in the base end direction along the inner needle 14, and when the engagement protrusion 45 of the cover body 41 reaches the tip of the arm part 53 of the blunt needle hub 51 that has passed through the inner needle hub 30, the engagement protrusion 45 and the engagement part 54 are engaged to be integrated as the safety member 40. That is, at this stage, the inner needle 14 is exposed from the tip of the safety member 40 to form the safety retaining assembly 130.

Next, the part (indwelling body) to which the catheter 12 and catheter hub 20 (including the valve member 22) have been previously fixed is assembled into the safety-retaining assembly 130 consisting of the inner needle 14 and safety member 40 (step S2). As shown in Fig. 17, with the valve member 22 inserted into the catheter hub 20, the tip of the inner needle 14 is inserted into the valve hole 25 of the valve member 22 from the base end side. At this time, the valve member 22 is easily opened because the tip cover part 42 of the cover body 41 has not yet been inserted. Therefore, the valve member 22 moves smoothly over the outer circumferential surface of the inner needle 14 while being prevented from being pierced by the inner needle 14.

Then, by continuing to move the catheter hub 20 in the axial direction (towards the base end), the catheter hub 20 is temporarily attached to the outer peripheral surface of the tip cover part 42. In this state, the catheter hub 20 and the tip cover part 42 are fitted together via the valve member 22. Then, distal to the catheter hub 20, a multiple tube 11 is formed in which the needle tip 15 of the inner needle 14 protrudes from the tip of the catheter 12.

In the above-mentioned state of the multi-layer tube 11, as shown in FIG. 15, a process of immersing (dipping) the catheter 12 and the inner needle 14 in the coating material 13 is performed (step S3). In this dipping, the coating material 13 is stored in a storage tank (not shown), and the tip of the multi-layer tube 11 having the safety retaining assembly 130 at its base end is directed downward and entered downward from above the stored liquid. Then, the catheter hub 20 waits for a certain period of time in a position where it is not immersed, and then the multi-layer tube 11 is pulled upward. As a result, the coating material 13 is applied to the surface of the catheter 12 and the needle tip 15. In addition, since the catheter operating member 60 is not attached during dipping, the coating material 13 is not applied to the catheter operating member 60.

After the coating material 13 is formed, a process of incorporating the catheter operating member 60 is performed (step S4). In this process, the catheter hub 20 and the safety member 40, which have been fitted together for dipping, are separated. That is, as shown in FIG. 17, the catheter hub 20 is moved axially (towards the tip) relative to the safety member 40 (safety retaining assembly 130). This exposes the inner needle 14 at a position proximal to the valve member 22 of the catheter hub 20 and distal to the tip cover portion 42.

With the inner needle 14 exposed between the base end of the valve member 22 and the tip of the safety member 40, the catheter operating member 60 is attached from the side. Here, the width W of the slit 63b formed in the operating part tubular portion 63 of the catheter operating member 60 is larger than the outer diameter φ of the inner needle 14, so that the inner needle 14 can be smoothly inserted into the insertion space 63a of the operating part tubular portion 63 through the slit 63b. In addition, because the lower side of the hub accommodation portion 62 of the catheter operating member 60 is open, the catheter hub 20 (including the valve member 22) can be easily inserted into the accommodation chamber 62a with the inner needle 14 inserted.

Then, with the catheter hub 20 (including the valve member 22) housed in the catheter operating member 60, the catheter hub 20 and the catheter operating member 60 are moved in the proximal direction. This causes the tip of the safety member 40 to be reinserted into the valve hole 25 of the valve member 22. Then, when the base end of the operating part tube portion 63 of the catheter operating member 60 reaches the tip of the connecting portion 43a between the tip cover portion 42 and the proximal extension portion 43 of the safety member 40, the safety member 40 is tightly fitted into the valve member 22. This results in the construction of an inner/outer needle assembly 16 in which the catheter 12, catheter hub 20, inner needle 14, inner needle hub 30, safety member 40, and catheter operating member 60 are assembled.

Then, in the assembly process, the previously assembled internal and external needle assembly 16 is placed in the lower grip 90 (step S5). At this time, the lower grip 90 is left in a state in which the lower support member 120 is attached by the above-mentioned assembly method (see Figs. 13A and 13B). In the assembly process, as shown in Fig. 18, the internal and external needle assembly 16 is inserted from the upper open portion of the lower grip 90 toward the lower side (arrow C2 side), and the multiple fixing protrusions 34 of the internal needle hub 30 are inserted and fitted into the multiple mounting holes 94 of the lower grip 90 (see also Fig. 11). This causes the internal and external needle assembly 16 to engage with the lower grip 90.

Here, the safety guide space 99 (space portion 110) and the operating member guide space 100 formed between the upper grip 70 and the lower grip 90 are open when the upper grip 70 is separated from the lower grip 90. Therefore, the safety member 40 and the catheter operating member 60 can be easily positioned by inserting the inner/outer needle assembly 16 into the lower grip 90 toward the arrow C2 side.

Finally, in the assembly, the upper grip 70 is attached to the lower grip 90 with which the inner and outer needle assembly 16 is engaged (step S6). That is, the upper grip 70 is moved from above to below (the arrow C2 side) the lower grip 90, and the distal end fixing hooks 80 of the first and second upper protruding pieces 78a, 78b of the upper grip 70 are inserted into the first and second fixing holes 103a, 105b of the lower grip 90 and hooked onto the first protruding body 103 and the second protruding body upper block 105. The proximal end fixing hook 84 and the fixing protrusion 85 of the upper grip 70 are inserted into the third fixing hole 115a of the lower grip 90, and the proximal end fixing hook 84 is hooked onto the proximal end flange 115. In this way, the upper grip 70 and the lower grip 90 are firmly integrated as the grip 18 by fixing the two points at the distal end sandwiching the catheter operating member 60 and one point at the proximal end to each other.

The catheter assembly 10 is in a pre-puncture state when the upper grip 70 and the lower grip 90 are fixed together. In this state, the safety guide space 99 (space 110) in which the pair of projections 44 (engaged protrusions 48) of the safety member 40 are disposed is closed in the direction of arrow A of the upper grip 70 and the lower grip 90, making the pair of projections 44 unable to be separated. In addition, in the inner-outer needle assembly 16, the inner needle hub 30 is fixed to the grip 18, making the inner needle 14 immovable, while the catheter 12, catheter hub 20, safety member 40, and catheter operating member 60 can advance and retreat relative to the inner needle 14.

The present invention is not limited to the above embodiment, and various modifications are possible in accordance with the gist of the invention. For example, the attachment mechanism 33 that fixes the inner needle hub 30 and the lower grip 90 is not limited to the above, and may have various configurations (adhesive structure, hook fixing structure, etc.). Furthermore, the fixing mechanism 79 that fixes the upper grip 70 and the lower grip 90 is also not limited to the above, and may have various configurations (adhesive structure, interlocking structure, etc.).

[Modifications]
19A and 19B, a catheter assembly 10A according to a modified example differs from the above-described catheter assembly 10 in that a structure for guiding and limiting the movement of the safety member 40A is provided in a direction different from the location where the operation portion of the catheter operation member 60A is located. In the following description, elements having the same configuration or function as those in the above-described embodiment will be denoted by the same reference numerals and detailed description thereof will be omitted.

Specifically, the grip 18A of the catheter assembly 10A can be separated into an upper grip 140 and a lower grip 150, and the upper grip 140 has a ceiling wall 71 and a rear block body 141 on the side of the arrow A2, and is configured without a side wall.

The lower grip 150 has a bottom wall 91 and a pair of side walls 77, but does not have a rear wall on the side of arrow A2. The lower grip 150 also has a guide long hole 151 (safety guide space 99) in the bottom wall 91 that guides the locked protrusion 48A of the safety member 40A. The guide long hole 151 is closed at the tip when the lower grip 150 is alone, but is open at the base end. The base end open portion of this guide long hole 151 is closed by the rear block body 141 when the upper grip 140 is attached to the lower grip 150.

When the upper grip 140 and the lower grip 150 are assembled, an operating member guide space 100 is formed between the ceiling wall 71 of the upper grip 140 and each side wall 77 of the lower grip 150. A pair of wings 68 (operating portion) of the catheter operating member 60A are disposed in each of the pair of operating member guide spaces 100. The catheter operating member 60A is engaged with the catheter hub 20 or the safety member 40A, and the user can advance and retreat the catheter 12, the catheter hub 20, and the safety member 40A based on the operation of the pair of wings 68.

The inner and outer needle assembly 16A of the catheter assembly 10A is constructed by assembling the catheter 12, the catheter hub 20, the inner needle 14, the inner needle hub 30, the safety member 40A, and the catheter operating member 60A. The inner needle hub 30 fixes the base end of the inner needle 14 and is fixed to a mounting portion (not shown) on the base end side of the lower grip 150 constituting the attachment mechanism 33. The safety member 40A has the above-mentioned interlocking protrusion 48A at the base end of the tubular portion through which the inner needle 14 is inserted. The interlocking protrusion 48A protrudes a predetermined length toward the arrow C2 side, and its protruding end is configured to be wider than the guide long hole 151. Therefore, the interlocking protrusion 48A (safety member 40A) is prevented from coming off the guide long hole 151 in the assembled state.

The long guide hole 151 extends along the longitudinal direction (direction of arrow A) of the lower grip 150, and a blocking portion 152 at its tip reaches near the tip of the lower grip 150. A locking portion 153 (part of the safety movement limiting mechanism 49) that limits the movement of the locked protrusion 48A (safety member 40A) at the advanced position of the locked protrusion 48A is provided slightly toward the base end side of the blocking portion 152 of the long guide hole 151.

The locking portion 153 is composed of a blocking portion 152 at the tip of the guide long hole 151 and a convex portion 154 (return piece portion) that narrows the guide long hole 151 inward in the width direction. The convex portion 154 elastically deforms when the locked convex portion 48A advances in the direction of arrow A1 to move the locked convex portion 48A to the advanced position, while restricting the locked convex portion 48A that has moved to the advanced position from retracting in the direction of arrow A2. As a result, the safety member 40A is exposed from the grip 18A together with the catheter hub 20 and is restricted in movement in a state in which it covers the needle tip 15 of the inner needle 14 in the advanced position, and erroneous puncture of the inner needle 14 can be effectively prevented.

In the above catheter assembly 10A, the pair of wings 68 of the catheter operating member 60A are arranged at the boundary (operating member guide space 100) between the upper grip 140 and the lower grip 150, making them movable. This simplifies the delivery of the catheter operating member 60A from the grip 18A. In addition, because the safety movement limiting mechanism 49 of the safety member 40A is not shared with the operating member guide space 100, the configuration of the tip of the grip 18A is simplified, making it possible to more firmly limit the advancement and retreat of the safety member 40A in the advanced position.

The technical ideas and effects that can be understood from the above embodiments are described below.

One aspect of the present invention is a catheter assembly 10 including a catheter 12, a catheter hub 20 that holds the catheter 12, an inner needle 14 inserted into the catheter 12, a catheter operating member 60 that allows the user to operate the movement of the catheter 12 and the catheter hub 20, and a safety member 40 that is inserted into the catheter hub 20 and engages with it to move together with the catheter hub 20 and advances beyond the needle tip 15 of the inner needle 14 that has punctured the treatment target to activate an anti-insertion function for the inner needle 14. The catheter operating member 60 has a tubular portion (operating portion tubular portion 63) having an insertion space 63a through which the safety member 40 is inserted, and a slit 63b extending in the axial direction of the tubular portion, and the slit 63b allows the inner needle 14 to pass from the side of the tubular portion into the insertion space 63a, but prevents the safety member 40 from passing from the insertion space 63a to the side of the tubular portion.

The catheter assembly 10 is configured such that the safety member 40 is inserted and fitted into the catheter hub 20, so that the catheter hub 20 and the safety member 40 can be fitted in the axial direction when the inner needle 14 is inserted into the catheter hub 20 and the safety member 40. Moreover, the catheter operating member 60 has a cylindrical portion (operating portion cylindrical portion 63) and a slit 63b, which allows the inner needle 14 to pass through while preventing the safety member 40 from passing through. As a result, the catheter operating member 60 can be attached from the side of the inner needle 14 through the slit 63b when the inner needle 14 is inserted into the catheter hub 20 and brought close to the tip of the safety member 40. Furthermore, it is possible to insert the safety member 40 with the cylindrical portion inserted into the catheter hub 20 by facing the safety member 40. Therefore, the assembly of the catheter hub 20, the safety member 40, and the catheter operating member 60 is simplified, and the work efficiency can be significantly improved.

In addition, the width W of the slit 63b is larger than the diameter (outer diameter φ) of the inner needle 14 and smaller than the width (outer diameter D) of the safety member 40. This allows the catheter assembly 10 to pass the inner needle 14 through the slit 63b with a simple configuration, and also prevents the safety member 40 from passing through the slit 63b, thereby maintaining the assembled state of the catheter operating member 60 and the safety member 40.

In addition, the catheter hub 20 is configured so that the valve member 22 is inserted therein, and the safety member 40 is inserted into the valve hole 25 of the valve member 22 and fitted into the catheter hub 20 via the valve member 22. This allows the catheter assembly 10 to hold the safety member 40 in the catheter hub 20 via the valve member 22 with an appropriate fitting force.

The catheter operating member 60 also has a hub housing 62 that houses the catheter hub 20, and is configured to move the catheter hub 20 and the safety member 40 as the hub housing 62 moves due to user operation, and further, the hub housing 62 can be detached from the catheter hub 20 based on the release of the engagement between the catheter hub 20 and the safety member 40. This allows the catheter assembly 10 to easily detach the catheter hub 20 from the catheter operating member 60 when the engagement between the catheter hub 20 and the safety member 40 is released.

In addition, the catheter 12 and the inner needle 14 are immersed in a predetermined coating material 13 while overlapping each other, so that the coating material 13 is applied to the surfaces. This allows the catheter 12 and the inner needle 14 to be immersed in the coating material 13 while overlapping each other when manufacturing the catheter assembly 10, simplifying the manufacturing process and further improving work efficiency.

In addition, the coating material 13 is a material that reduces the insertion resistance of the catheter 12 into the treatment subject. As a result, by applying the coating material 13 to the multi-layer tube 11 in which the catheter 12 and the inner needle 14 are stacked, the insertion of the catheter 12 into the treatment subject is made smoother.

In addition, the catheter operating member 60 has an operating section (operating plate section 61) that extends further distal than the catheter hub 20 and is operated by the user, and is inserted into the catheter hub 20 and the safety member 40 after the coating material 13 has been applied. This makes it possible to apply the coating material 13 to the multiple tube 11 without the catheter operating member 60 being present when manufacturing the catheter assembly 10, further simplifying assembly and reducing manufacturing costs.

In addition, the portion where the safety member 40 is inserted into the catheter hub 20 and the tubular portion (operation portion tubular portion 63) and the tubular portion are formed cylindrically, and the inner diameter of the tubular portion is set to a dimension that has a marginal space 63a1 with respect to the outer diameter of the inserted safety member 40. This allows the catheter assembly 10 to smoothly insert the safety member 40 when inserting the safety member 40 into the tubular portion of the catheter operation member 60 and inserting the safety member 40 into the catheter hub 20. Furthermore, in a configuration in which the safety member 40 and the tubular portion of the catheter operation member 60 are formed cylindrically, the safety member 40 can be rotated relative to one another when inserting it into the catheter hub 20, making it possible to stably insert and engage the safety member 40.

In addition, the length L along the axial direction of the tubular portion (operation portion tubular portion 63) is set to at least 1/3 of the axial length of the hub housing portion 62 that houses the catheter hub 20 in the catheter operating member 60. As a result, in the catheter assembly 10, the distance over which the tubular portion of the catheter operating member 60 and the safety member 40 overlap is increased, and bending of the catheter operating member 60 relative to the safety member 40 during operation of the catheter operating member 60 is suppressed. Therefore, the catheter operating member 60 can move the safety member 40 smoothly.

Claims (9)

A catheter;
a catheter hub for holding the catheter;
an inner needle inserted into the catheter;
a catheter manipulation member for allowing a user to manipulate the movement of the catheter and the catheter hub;
a safety member that is inserted into and fitted into the catheter hub to be movable together with the catheter hub and that advances beyond the tip of the inner needle that has punctured a treatment target to activate a function of preventing accidental puncture of the inner needle,
the catheter operating member has a cylindrical portion having an insertion space through which the safety member is inserted, and a slit extending in an axial direction of the cylindrical portion,
the slit allows the inner needle to pass from the side of the cylindrical portion into the insertion space, while preventing the safety member from passing from the insertion space to the side of the cylindrical portion. The catheter assembly according to claim 1,
a width of the slit is larger than a diameter of the inner needle and smaller than a width of the safety member. The catheter assembly according to claim 1 or 2,
the catheter hub is configured to have a valve member inserted therein;
The safety member is inserted into a valve hole of the valve member and fitted into the catheter hub via the valve member. The catheter assembly according to any one of claims 1 to 3,
the catheter operation member has a hub housing portion that houses the catheter hub, and is configured to move the catheter hub and the safety member in accordance with movement of the hub housing portion by a user's operation,
Furthermore, the catheter assembly is configured so that the hub housing portion can be detached from the catheter hub upon release of the engagement between the catheter hub and the safety member. The catheter assembly according to any one of claims 1 to 4,
The catheter and the inner needle are immersed in a predetermined coating material while overlapping each other, so that the coating material is applied to the surface of the catheter and the surface of the inner needle . The catheter assembly according to claim 5,
The coating material is a material that reduces the insertion resistance of the catheter into the treatment target. The catheter assembly according to claim 5 or 6,
The catheter operating member has an operating portion that extends further distal than the catheter hub and is operated by the user, and is inserted into the catheter hub and the safety member after the coating material is applied. The catheter assembly according to any one of claims 1 to 7,
The portion where the safety member is inserted into the catheter hub and the cylindrical portion, and the cylindrical portion are formed into a cylindrical shape,
a catheter assembly, wherein an inner diameter of the cylindrical portion is set to a dimension that provides a margin of clearance with respect to an outer diameter of the safety member through which the cylindrical portion is inserted. The catheter assembly according to any one of claims 1 to 8,
A catheter assembly, wherein the axial length of the cylindrical portion is set to at least 1/3 of the axial length of a hub accommodating portion of the catheter operating member that accommodates the catheter hub.

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