WO2023162902A1

WO2023162902A1 - Catheter assembly

Info

Publication number: WO2023162902A1
Application number: PCT/JP2023/005884
Authority: WO
Inventors: 水野慎一; 市川翔平
Original assignee: テルモ株式会社
Priority date: 2022-02-25
Filing date: 2023-02-20
Publication date: 2023-08-31

Abstract

A catheter assembly (10) provided with an opening member (24) that is positioned adjacent to a hemostatic valve (22) positioned inside a catheter hub (18). The opening member (24) comprises: a cylindrical body part (30); a housing part (36a) surrounded by the inner circumferential face of the body part (30) and extending in the axial direction; a neck part (32) extending from the body part (30) toward the tip while being reduced in diameter; a pair of foot parts (34) extending from the base end of the body part (30) toward the base end side; and a reinforcing rib (40) extending in the axial direction from the inner circumferential face of at least one foot part (34) and the inner circumferential face of the body part (30) adjacent to the foot part (34) toward the center of the opening member (24) in a bulged and thickened manner.

Description

catheter assembly

The present invention relates to a medical catheter assembly.

The catheter assembly is left in the patient's blood vessel and used for infusion of fluids to the patient. For example, the catheter assembly shown in WO2019/065943 comprises a catheter and an inner needle assembly inserted inside the catheter. Among these, the catheter is left in the patient's blood vessel. The inner needle assembly is withdrawn from the catheter after introducing the catheter into the blood vessel.

The catheter has a catheter body and a catheter hub. The catheter hub is a portion that supports the base of the catheter body, and has a hemostasis valve and an opening member inside. A hemostasis valve is a valve that prevents backflow of blood when a catheter body is inserted into the body. The opening member, also called a plug, is a member that opens the hemostatic valve. When a male connector such as an infusion line or a syringe is connected to the catheter hub, the opening member comes into contact with the distal end of the male connector and advances toward the hemostasis valve to open the hemostasis valve.

In addition, Japanese National Publication of International Patent Application No. 2018-529408 discloses a protective member that covers the tip of the inner needle when the inner needle assembly is removed. The protection member disclosed in JP-T-2018-529408 is housed in the opening member.

With conventional catheter hubs, although rare, when the tip of the male connector is connected to the catheter, the opening member does not advance and the hemostasis valve does not open. When such an event occurs, the hemostasis valve may not open no matter how much the male connector is pushed, requiring replacement of the catheter.

Therefore, there is a demand for a catheter assembly that can prevent poor opening of the hemostasis valve and that can be easily mass-produced.

An object of the present invention is to solve the above problems.

The present invention discloses the following catheter assembly.
[1] a catheter body, a catheter hub supporting the proximal end of the catheter body, a hemostasis valve disposed inside the catheter hub, and a hemostasis valve inside the catheter hub adjacent to the proximal end of the hemostasis valve an opening member arranged to open the hemostasis valve, wherein the opening member is surrounded by a cylindrical body that slides on the inner peripheral surface of the catheter hub, and the inner peripheral surface of the body; a housing portion extending in the axial direction, a neck portion extending from the body portion toward the distal end with a reduced diameter, a pair of legs extending from the proximal end of the body portion toward the proximal end side, and at least A reinforcing rib having a apex that bulges from the inner peripheral surface of one of the legs toward the center of the opening member, the apex being the thickest among the legs and extending in the axial direction. and a catheter assembly.

In the above-described catheter assembly, the reinforcing ribs prevent deformation of the foot of the opening member, so that the opening member can be reliably advanced and the hemostatic valve can be prevented from failing to open.

[2] The catheter assembly according to item [1], wherein the reinforcing rib is formed on the inner peripheral surface of each of the pair of legs. This catheter assembly can reinforce the leg without providing a projecting portion to the outer peripheral surface of the opening member.

[3] The catheter assembly according to item [1] or [2], wherein the reinforcing rib has the same width as the foot. This catheter assembly can increase the rigidity of the foot portion of the opening member to suppress deformation of the foot portion.

[4] The catheter assembly according to item [3], wherein the reinforcing rib includes a top portion that protrudes most inwardly at a center position in the width direction of the foot portion, and both sides of the top portion in the circumferential direction. and a gradually tapering curved contoured portion located at the . Since this catheter assembly can suppress contact between the protective member and the reinforcing ribs when the protective member is assembled, it is possible to prevent the occurrence of defective products and the contamination of foreign substances.

[5] In the catheter assembly according to item [1] or [2], the width of the reinforcing rib is narrower than the width of the foot, and the central position of the reinforcing rib in the width direction A catheter assembly spaced from a line connecting the widthwise center of the foot and the axis of the opening member. This catheter assembly can more effectively prevent contact between the protective member and the reinforcing ribs, and can prevent the occurrence of defective products and the contamination of foreign substances.

[6] The catheter assembly according to any one of items [1] to [5], wherein the reinforcing rib is formed between the reinforcing rib of one leg and the reinforcing rib of the other leg. The width of the gap may be smaller than the outer diameter of the tip of the connector connected to the catheter hub. The catheter assembly ensures advancement of the opening member by preventing entry of the male connector between the legs of the opening member.

[7] The catheter assembly according to any one of items [1] to [6], wherein the outer peripheral portion of the trunk has a cylindrical surface, and the outer peripheral surface of the foot portion is the outer circumference of the trunk. A catheter assembly having the same cylindrical surface as the section. This catheter assembly can suppress sliding resistance between the outer peripheral surface of the foot and the catheter hub.

[8] The catheter assembly according to any one of items [1] to [7], wherein the reinforcing rib, the leg portion, and the trunk portion are integrally molded from resin. Three-dimensional. This catheter assembly can reduce manufacturing costs.

[9] The catheter assembly according to any one of items [1] to [8], wherein the reinforcing rib extends from the inner peripheral surface of the leg portion to the inner peripheral surface of the trunk portion. , catheter assembly. This catheter assembly allows the opening member to be advanced more reliably.

[10] The catheter assembly according to any one of items [1] to [9], further comprising: an inner needle inserted inside the catheter body; and the inner needle attached to the inner needle. a protective member that covers the needle tip of the inner needle when the catheter assembly is withdrawn, wherein the protective member is housed in the housing portion of the opening member. This catheter assembly can compactly accommodate the protective member.

[11] The catheter assembly according to item [5], further comprising: an inner needle inserted inside the catheter body; a protective member covering the needle tip, wherein the protective member is accommodated in the accommodating portion of the opening member, and the protective member occupies a trapezoidal range when viewed from the proximal direction, A catheter assembly in which a wide portion at one end of a protective member is positioned away from said reinforcing ribs, and a narrow portion at the other end of said protective member is positioned near said reinforcing ribs. This catheter assembly can prevent contact between the reinforcing ribs of the opening member and the protective member even if the protective member is slightly misaligned in the assembly process.

In the catheter assembly of the above-mentioned viewpoint, the leg portion of the opening member is provided with a reinforcing rib that protrudes thickly. The reinforcing rib prevents the leg from bending when it comes into contact with the distal end of the male connector, thereby preventing the leg of the opening member from being pressed by the catheter hub and stuck due to frictional force.

1 is an exploded perspective view of a catheter assembly according to a first embodiment; FIG. 2A is a perspective view of the opening member of FIG. 1, and FIG. 2B is a plan view showing the appearance of the opening member of FIG. 1 when viewed from the proximal end. 3 is a cross-sectional view along the axis of the opening member of FIG. 1, showing a cross-section along the widthwise center of a pair of legs. 4A is a perspective view of the protection member in FIG. 1, and FIG. 4B is a perspective cross-sectional view showing a cross section along the axial direction of the protection member in FIG. FIG. 5 is a perspective view of an opening member containing a protective member; FIG. 6 is a cross-sectional view for explaining a step of assembling the catheter in the manufacturing method of the catheter assembly of FIG. FIG. 7 is an explanatory view of the process of inserting the inner needle and the protective member into the opening member of the catheter of FIG. 6; 8A is a cross-sectional view of a state in which the protection member is accommodated in the opening member, and FIG. 8B is an explanatory view of the opening member and the protection member in FIG. 8A viewed from the proximal end side. FIG. 9 is a cross-sectional view for explaining the step of attaching the needle hub to the catheter hub in the manufacturing method of the catheter assembly of FIG. 10A is a diagram for explaining the operation of connecting the male connector to the catheter hub after removing the inner needle, relating to the method of using the catheter assembly of FIG. 1, and FIG. 10B is a contact portion between the opening member and the male connector is a schematic diagram showing the force acting on the . 11A is an explanatory view of the case where there is no angular deviation in the step of housing the protective member in the opening member in the manufacturing method of the catheter assembly of FIG. 1, and FIG. 11B is an illustration in which the protective member is inclined with respect to the opening member. It is an explanatory view of the case. 12A is a perspective view of an opening member according to a second embodiment, and FIG. 12B is a plan view showing the appearance of the opening member of FIG. 12A viewed from the proximal side. 13A and 13B are explanatory diagrams of a process of assembling a protective member to the opening member of FIG. 12A. 14A is a perspective view of an opening member according to a third embodiment, and FIG. 14B is a plan view showing the appearance of the opening member of FIG. 14A viewed from the proximal side. 15A and 15B are explanatory diagrams of a process of assembling the protective member to the opening member of FIG. 14A.

(First embodiment)
A catheter assembly 10 according to one embodiment of the present invention has a catheter 12 and an inner needle assembly 14, as shown in FIG. The catheter assembly 10 has a structure in which the inner needle assembly 14 is assembled from the proximal end side of the catheter 12 in the initial state (state of product provision) before use. The catheter 12 is used for fluid transfusion, blood transfusion, and the like. Catheter 12 is, for example, a peripheral venous catheter. Note that catheter 12 may be a central venous catheter, a PICC, or a midline catheter. In addition, the catheter 12 is not limited to a venous catheter, and may be an arterial catheter such as a peripheral arterial catheter.

As shown in FIG. 1, the catheter 12 has a catheter body 16 and a catheter hub 18. The catheter body 16 is a hollow body having a lumen 15 inside. The catheter body 16 and lumen 15 extend axially. The catheter body 16 and the lumen 15 have circular cross sections perpendicular to the axial direction. The lumen 15 communicates with a distal opening 15 a formed at the distal end of the catheter body 16 and a proximal opening 15 b formed at the proximal end of the catheter body 16 . The catheter body 16 has flexibility. The material constituting the catheter body 16 is not particularly limited, but a transparent soft resin material can be applied.

A catheter hub 18 is fixed to the proximal end of the catheter body 16 . The catheter hub 18 has a tubular shape that tapers in the distal direction. The catheter hub 18 has an internal space 18a inside. The internal space 18a communicates with the lumen 15 of the catheter body 16 on the distal end side. The internal space 18a opens as a proximal open portion 18b on the proximal side.

A flange 18 c is formed on the outer peripheral surface of the proximal end of the catheter hub 18 . The flange 18c extends along the circumferential direction. The catheter hub 18 accommodates a hemostasis valve 22, an opening member 24, and a fixing member 26 in an internal space 18a.

The hemostasis valve 22 is a valve that blocks blood flowing from the lumen 15 of the catheter body 16 into the internal space 18a from leaking from the proximal end opening 18b. The hemostatic valve 22 is, for example, a duckbill valve, and has a slit 22a on the distal end side. The hemostasis valve 22 is opened by inserting an opening member 24 disposed on the proximal side to open the slit 22a.

The opening member 24 is arranged on the proximal side of the hemostatic valve 22 . The opening member 24 has a cylindrical body portion 30, a neck portion 32 connected to the distal end of the body portion 30 and protruding in the distal direction, and a pair of leg portions 34 projecting from the proximal end of the body portion 30 in the proximal direction. . A space portion 36 of the opening member 24 is formed inside the body portion 30 and the neck portion 32 .

As shown in FIG. 2A, the outer peripheral portion 30a of the body portion 30 has a cylindrical surface. The outer diameter of the outer peripheral portion 30 a is slightly smaller than the inner diameter of the inner space 18 a of the catheter hub 18 . The outer diameter of the outer peripheral portion 30a is constant throughout the axial direction. The trunk portion 30 has an accommodating portion 36a inside. The accommodation portion 36 a is a space surrounded by the inner peripheral portion 30 b and occupies a portion of the space portion 36 .

The inner peripheral portion 30b includes a curved portion 30c, a flat portion 30d, and an inclined portion 30e. The flat portion 30d is formed by a flat surface. A pair of flat portions 30d are formed with an interval of 180° in the circumferential direction of the inner peripheral portion 30b. Each flat portion 30d is located on the tip end side of the leg portion 34 in the axial direction and extends in the axial direction. The curved surface portion 30c is arranged between the pair of flat portions 30d. The curved surface portion 30c has a cylindrical surface formed concentrically with the outer peripheral portion 30a. The inclined portion 30e has an inclined surface formed at the proximal end of the curved surface portion 30c. The inclined portion 30e guides the protective member 46 to the space portion 36 when the later-described protective member 46 is attached to the opening member 24. As shown in FIG.

The body portion 30 further has a window portion 30f obtained by cutting out a portion of the curved surface portion 30c in a rectangular shape. The window portion 30f accommodates a portion of the protection member 46 in the initial state.

The neck portion 32 passes through the slit 22a of the hemostatic valve 22 to open the hemostatic valve 22 when the opening member 24 moves to the distal end side. The neck portion 32 has a cylindrical shape with an outer diameter smaller than that of the body portion 30 . In the initial state, neck 32 is positioned inside hemostasis valve 22 . The step between the neck portion 32 and the body portion 30 prevents the movement of the opening member 24 in the distal direction by being caught by the hemostatic valve 22 when the opening member 24 moves distally.

The neck 32 has a neck-side space 36b inside. The neck-side space 36b is connected to the housing portion 36a and constitutes a part of the space portion 36. As shown in FIG. Neck 32 has a side hole 38 . The side hole 38 penetrates the outer peripheral surface and the inner peripheral surface of the neck portion 32 . The side hole 38 communicates the neck-side space 36b with the outside.

The pair of leg portions 34 are integrally connected to the body portion 30 at the proximal end 30g of the body portion 30. One foot portion 34 and the other foot portion 34 are arranged with an interval of 180° in the circumferential direction. The one leg portion 34 and the other leg portion 34 extend from the proximal end 30g of the trunk portion 30 toward the proximal end side in the axial direction by a predetermined length. The one leg portion 34 and the other leg portion 34 have a rectangular shape when viewed from the side.

The outer peripheral surfaces 34a of the pair of leg portions 34 are cylindrical surfaces and have the same outer diameter as the outer peripheral portion 30a of the body portion 30. A reinforcing rib 40 is formed on the inner peripheral surface 34 b of the leg portion 34 . The reinforcing rib 40 is a protrusion that protrudes inward from the flat portion 30d of the inner peripheral portion 30b of the body portion 30. As shown in FIG. As shown in FIG. 2B, the reinforcing rib 40 bulges most inward at the center position of the leg portion 34 in the circumferential direction when viewed from the base end side.

The reinforcing ribs 40 gradually decrease in swelling toward both ends of the leg portion 34 in the circumferential direction. The inner surface 40a of the reinforcing rib 40 has an arcuate curved shape when viewed from the base end side. The inner surface 40a has a top portion 40c that bulges inward most at the center position in the width direction of the foot portion 34, and curved portions 40d that are located on both sides of the top portion 40c in the circumferential direction and gradually become thinner. The portion of the leg portion 34 where the reinforcing rib 40 is formed is thicker than the flat portion 30d of the body portion 30. As shown in FIG.

The distance between the reinforcing rib 40 of one leg 34 and the reinforcing rib 40 of the other leg 34 is smaller than the outer diameter of the tip of the male connector 102 of the medical device 100 (FIG. 10A). With this configuration, it is possible to prevent the male connector 102 from entering between the leg portions 34, and the opening member 24 can be reliably advanced.

As shown in FIGS. 2A and 3, the reinforcing rib 40 of this embodiment extends from the proximal end 34c of the leg portion 34 to the distal end side of the trunk portion 30 in the axial direction. A tip 40 b of the reinforcing rib 40 is located on the tip side of the base end 30 g of the trunk portion 30 . In addition, the reinforcing rib 40 may extend to the tip of the trunk portion 30 . When the male connector 102 of the medical device 100 (to be described later) is inserted into the catheter hub 18, the leg 34 of the present embodiment abuts against the male connector 102 to advance the opening member 24 distally. The reinforcing ribs 40 are integrally connected to the body portion 30 and the leg portion 34 and increase the rigidity of the leg portion 34 . The reinforcing rib 40 prevents the curved portion of the distal end of the male connector 102 (FIG. 10A) from entering between the pair of legs 34 and also prevents the legs 34 from being deformed.

As shown in FIG. 1 , the fixing member 26 is arranged on the proximal side of the opening member 24 . The fixing member 26 is fixed to the catheter hub 18 by bonding, heat-sealing, crimping, or the like, thereby preventing the opening member 24 from falling off from the catheter hub 18 . The fixing member 26 has a pair of projecting pieces 26a. The projecting piece 26 a prevents the opening member 24 from rotating with respect to the catheter hub 18 by entering between the pair of leg portions 34 of the opening member 24 .

The inner needle assembly 14 includes an inner needle 42, a needle hub 44, and a protective member 46. The inner needle 42 is a hollow tube inserted through the lumen 15 of the catheter body 16 . The inner needle 42 has a sharp tip 42a at its tip. The inner needle 42 has a rigidity capable of puncturing the skin of a living body. The material of the inner needle 42 is, for example, metal material, hard resin, or ceramics. Inner needle 42 is secured to needle hub 44 at its proximal end.

The needle hub 44 is a part that becomes a grip that the user holds. Needle hub 44 includes a hub body 48 and a needle support 50 . The hub body 48 is a portion that is gripped by the user, and is provided with a ridge 48a for slip prevention. A needle support 50 protrudes from the distal end of the hub body 48 . The needle support portion 50 has a support tube 50a protruding from the hub body 48. As shown in FIG. The support tube 50a supports the inner needle 42 by coming into contact with the outer peripheral portion 42b of the inner needle 42 . The constituent material of the needle hub 44 is, for example, thermoplastic resin such as polypropylene resin.

The protective member 46 is arranged on the distal end side of the needle hub 44 and attached to the outer peripheral portion 42 b of the inner needle 42 . The protection member 46 has a base portion 52, a leaf spring 54, a shutter 56, and a sliding portion 58, as shown in FIGS. 4A and 4B. The base portion 52 and the leaf spring 54 are formed of a single metal plate and integrally connected to each other. The base portion 52 and the leaf spring 54 are connected via the bent portion 60 . The base 52 is a flat plate-like portion elongated in the axial direction.

On both sides of the base portion 52 , a pair of side plates 62 stand upright with an inclination with respect to the base portion 52 . The leaf spring 54 is connected to the base portion 52 via a bent portion 60 on the proximal end side. The leaf spring 54 is arranged between the pair of side plates 62 . The bent portion 60 is positioned at the proximal end of the base portion 52 and has a proximal insertion hole 64 . The leaf springs 54 are located on the distal end side of the bent portion 60 and arranged to face each other in the thickness direction of the base portion 52 . The leaf spring 54 has a tip insertion hole 66 at its tip. In the initial state, the inner needle 42 is inserted through the proximal end insertion hole 64 and the distal end insertion hole 66 . The plate spring 54 is biased toward the base portion 52 (lower side) by the bent portion 60 in the initial state.

A shutter 56 and a sliding portion 58 are joined to the leaf spring 54 . The shutter 56 is attached above the leaf spring 54 . In the initial state, the shutter 56 contacts the inner needle 42 from above. The sliding portion 58 is a member arranged between the leaf spring 54 and the base portion 52 and contacts the inner needle 42 from below. The inner needle 42 is inserted through the tip insertion hole 66 while being sandwiched between the shutter 56 and the sliding portion 58 .

The shutter 56 has a locking piece 70 at its upper end. As shown in FIG. 5, the protection member 46 is housed in the housing portion 36a of the opening member 24 in the initial state. In the initial state, the lock piece 70 is arranged in the window portion 30f of the opening member 24. As shown in FIG. The locking piece 70 prevents the protection member 46 from being pulled out from the opening member 24 by being caught on the window portion 30f.

As shown in FIG. 4B, the protective member 46 further has a tubular stopper 72 at the bent portion 60 . The stopper 72 has an inner diameter smaller than the outer diameter of the distal end portion of the inner needle 42 and prevents the distal end portion of the inner needle 42 from being pulled out from the protective member 46 toward the proximal end side. That is, a portion of the inner needle 42 near the tip 42a is intentionally flattened. Since the width of the flattened portion of the needle tip 42a is larger than the inner diameter of the stopper 72, the needle tip 42a is caught on the stopper 72 (protective member 46). As a result, the needle tip 42 a is held inside the protective member 46 .

The shutter 56 is supported by the leaf spring 54 and displaced together with the leaf spring 54 . When the inner needle 42 is pulled out from the tip insertion hole 66 , the shutter 56 is displaced toward the base 52 to cover the needle tip 42 a of the inner needle 42 . In this state, the locking piece 70 of the protective member 46 is pulled inside the window 30f in FIG. As a result, the protective member 46 can be removed from the catheter hub 18 .

The catheter assembly 10 of this embodiment is manufactured by the following assembly process.

First, the steps of assembling the catheter 12 and the inner needle assembly 14 are performed. As shown in FIG. 6, assembly of catheter 12 includes joining catheter body 16 to catheter hub 18 . After that, a step of attaching the hemostasis valve 22, the opening member 24 and the fixing member 26 to the catheter hub 18 in order is performed. The fixing member 26 is joined to the catheter hub 18 by a method such as gluing, heat sealing, or crimping.

In addition, the inner needle assembly 14 is assembled by a step of mounting the protective member 46 on the inner needle 42 and a step of joining the inner needle 42 to the needle hub 44 in the order of steps.

Next, the process of assembling the inner needle assembly 14 to the catheter 12 shown in FIG. 7 is performed by an automatic assembling machine. The catheter 12 is fixed to a fixing jig (not shown). Also, the inner needle assembly 14 is gripped by an assembly tool. The protection member 46 of the inner needle assembly 14 is held by an assembly tool so that the angle of the lock piece 70 matches the angle of the window portion 30f (catheter 12) of the opening member 24. As shown in FIG. Inner needle 42 of inner needle assembly 14 is then inserted into lumen 15 of catheter body 16 .

The protective member 46 advances toward the distal end together with the inner needle 42 . The protection member 46 is inserted into the receiving portion 36 a of the opening member 24 through the gap between the leg portions 34 . The lock piece 70 of the protection member 46 is inserted into the window portion 30f of the opening member 24 as shown in FIGS. 8A and 8B. After that, the needle support portion 50 of the needle hub 44 is fitted into the catheter hub 18 (fixing member 26), and the assembly of the inner needle assembly 14 and the catheter 12 is completed. Through the above steps, the catheter assembly 10 is completed.

The catheter assembly 10 of this embodiment works as follows.

In the catheter assembly 10 of FIG. 1, the catheter 12 is inserted into the patient's blood vessel together with the inner needle assembly 14 . The inner needle assembly 14 is withdrawn from the catheter 12 after the catheter 12 has been inserted into the patient's blood vessel. Thereafter, a male connector 102 of a medical device 100 such as an infusion line is inserted into the catheter hub 18, as shown in FIG. 10A. The male connector 102 abuts on the leg portion 34 of the opening member 24 and presses the opening member 24 toward the distal end. Since the opening member 24 of the present embodiment has the reinforcing ribs 40 on the foot portion 34, the outward deformation of the foot portion 34 can be prevented.

As a result, it is difficult for the male connector 102 to enter between the pair of legs 34 . As a result, the opening member 24 can prevent the feet 34 from being pressed against the inner wall of the catheter hub 18 and prevented from advancing due to frictional force. Therefore, in the catheter assembly 10 of the present embodiment, as shown in FIG. 10B, even if the male connector 102 has a rounded tip, the opening member 24 can be reliably advanced to the distal side, and the hemostasis valve is closed. 22 can be reliably opened.

(Second embodiment)
As shown in FIG. 11A, in the process of assembling the catheter assembly 10 of the first embodiment, if the angle of the protection member 46 and the angle of the opening member 24 are appropriate, the protection member 46 is attached to the pair of opening members 24. As shown in FIG. It is possible to smoothly assemble through the space between the legs 34.

However, in the assembly process using an automatic assembly machine, as shown in FIG. 11B, an error may occur in the angular positioning of the protective member 46, and an angular deviation of about 10° may occur. Such angular misalignment may cause the protective member 46 to come into contact with the reinforcing ribs 40 of the foot portion 34 . When the protective member 46 comes into contact with the foot portion 34, the protective member 46 is plastically deformed, causing malfunction. Moreover, even if the protective member 46 does not undergo plastic deformation, the reinforcing rib 40 may be scraped by the protective member 46 to generate foreign matter.

To prevent the manufacturing problems described above, the opening member 24A shown in FIG. 12A is applied to the catheter assembly 10 of FIG. The shape of the reinforcing rib 40A of the opening member 24A differs from the shape of the reinforcing rib 40 of the opening member 24. As shown in FIG. In the opening member 24A, the same components as those of the opening member 24 are denoted by the same reference numerals, and detailed description thereof will be omitted.

As shown in FIGS. 12A and 12B, the reinforcing rib 40A of the present embodiment has a circumferential width narrower than that of the foot portion 34 in the circumferential direction. The reinforcing rib 40A has a rectangular cross-sectional shape when viewed from the base end side. The reinforcing rib 40A is located at a portion deviated from the center of the leg portion 34 in the width direction. A center position 401 of the reinforcing rib 40A is away from a line 341 connecting the center of the pair of legs 34 in the width direction and the axis of the opening member 24A. Further, the reinforcing ribs 40A formed on each of the pair of leg portions 34 are located at sites away from the window portion 30f.

As shown in FIG. 13, the opening member 24A of the present embodiment can widen the gap between the pair of leg portions 34 on the side closer to the window portion 30f. The protective member 46 occupies a trapezoidal range when viewed from the proximal direction. A wide portion at one end of the protective member 46 is arranged at a position away from the reinforcing rib 40A. Also, the narrow portion of the other end of the protective member 46 is arranged at a position close to the reinforcing rib 40A. As a result, the opening member 24A can prevent the reinforcement rib 40A and the protection member 46 from coming into contact with each other even if the protection member 46 is slightly misaligned in the process of assembling the catheter assembly 10 .

(Third Embodiment)
This embodiment describes an alternative patency member 24B that can avoid the aforementioned manufacturing problems of catheter assembly 10 . In addition, in the opening member 24B, the same reference numerals are given to the same configurations as those of the opening member 24, and detailed description thereof will be omitted.

As shown in FIG. 14A, the opening member 24B has reinforcing ribs 40B on each of the pair of legs 34. As shown in FIG. The reinforcing rib 40B is positioned at the circumferential end of the leg 34 away from the window 30f. As shown in FIG. 14B, the reinforcing rib 40B has a triangular cross-sectional shape when viewed from the base end side. Although not particularly limited, the reinforcing rib 40B has a circumferential width narrower than the circumferential width of the foot portion 34, is biased with respect to the widthwise center of the foot portion 34, and is spaced apart from the window portion 30f. placed out of position.

It should be noted that the reinforcing rib 40B may have the same width as the width of the leg portion 34 in the circumferential direction, as indicated by the two-dot chain line in FIG. In this case, the gap formed between the reinforcing ribs 40B (the gap between the pair of legs 34) may have an inclined shape that gradually widens as it approaches the window 30f.

As shown in FIG. 15, the opening member 24B of this embodiment can widen the gap between the pair of legs 34 on the side near the window 30f. As a result, even if the protective member 46 is slightly misaligned during the assembly process of the catheter assembly 10, the reinforcing rib 40B of the opening member 24B and the protective member 46 are prevented from coming into contact with each other.

The present invention is not limited to the above-described embodiments, and can take various configurations without departing from the gist of the present invention.

Claims

a catheter body;
a catheter hub supporting the proximal end of the catheter body;
a hemostasis valve positioned inside the catheter hub;
an opening member disposed adjacent to the proximal end of the hemostasis valve inside the catheter hub and opening the hemostasis valve;
The opening member is
a cylindrical body that slides on the inner peripheral surface of the catheter hub;
an accommodating portion surrounded by the inner peripheral surface of the body portion and extending in the axial direction;
a neck portion extending from the body portion toward the tip with a reduced diameter;
a pair of legs extending from the proximal end of the trunk toward the proximal end;
A reinforcement extending in the axial direction and having a apex that bulges from the inner peripheral surface of at least one of the legs toward the center of the opening member, the apex being the thickest among the legs and extending in the axial direction. and ribs.
The catheter assembly according to claim 1, wherein the reinforcing ribs are formed on the inner peripheral surface of each of the pair of legs.
The catheter assembly according to claim 1 or 2, wherein said reinforcing ribs are the same as the width of said foot.
4. The catheter assembly according to claim 3, wherein the reinforcing ribs are formed at the most inwardly bulging apex at the center position in the width direction of the foot, and at both sides of the apex in the circumferential direction. and a curved contoured portion that tapers into a thin wall.
3. The catheter assembly according to claim 1, wherein the width of said reinforcing rib is narrower than the width of said leg, and the central position of said reinforcing rib in the width direction is the width of said leg. A catheter assembly spaced from a line connecting the center and the axis of the opening member.
2. The catheter assembly of claim 1, wherein the width of the gap formed between the stiffening rib of one leg and the stiffening rib of the other leg is connected to the catheter hub. a catheter assembly that is smaller than the outer diameter of the tip of the connector that
The catheter assembly according to claim 1, wherein the outer circumference of the body has a cylindrical surface, and the outer circumference of the foot has the same cylindrical surface as the outer circumference of the body.
The catheter assembly according to claim 1, wherein said reinforcing rib, said foot portion and said trunk portion are integrally molded from resin.
The catheter assembly according to claim 1, wherein the reinforcing rib extends from the inner peripheral surface of the foot portion to the inner peripheral surface of the trunk portion.
The catheter assembly of claim 1, further comprising:
an inner needle inserted inside the catheter body;
a protective member attached to the inner needle and covering the tip of the inner needle when the inner needle is removed;
The catheter assembly, wherein the protection member is housed in the housing portion of the opening member.
6. The catheter assembly of claim 5, further comprising:
an inner needle inserted inside the catheter body;
a protective member attached to the inner needle and covering the tip of the inner needle when the inner needle is removed;
The protection member is housed in the housing portion of the opening member, and
The protective member occupies a trapezoidal range when viewed from the proximal direction, the wide portion at one end of the protective member is located away from the reinforcing rib, and the narrow portion at the other end of the protective member positioned proximate to said stiffening ribs.