JP6712481B2 - Catheter assembly - Google Patents

Description

The present invention relates to a catheter assembly that is punctured and indwelled in a blood vessel, for example, when performing infusion or the like on a patient.

In infusion, a catheter assembly is used to construct an infusion line lead to the patient. For example, the catheter assembly includes a catheter, a catheter hub that holds the catheter fixed, an inner needle that is inserted into the catheter, and a needle hub that holds the inner needle fixed (see Patent Document 1). Further, the catheter assembly disclosed in Patent Document 1 is configured as a so-called midline catheter having a long catheter and an inner needle in order to insert the catheter deep inside the blood vessel. In this catheter assembly, the catheter and the inner needle are stacked and accommodated in the needle hub, and the catheter hub can be moved forward and backward by a catheter operating member.

When using this type of catheter assembly, a user such as a doctor or a nurse performs an operation (medical procedure) according to the following procedures (a) to (f).
(A) Puncture the inner needle and catheter into the patient's body.
(B) The catheter operating member is advanced to advance the catheter relatively to the inner needle.
(C) Withdrawing the inner needle from the patient's body by retracting the inner needle hub relative to the catheter and the catheter hub.
(D) Discard the removed inner needle and inner needle hub.
(E) Grasp the catheter hub with one hand and the catheter operating member with the other hand to remove the catheter operating member from the catheter hub.
(F) Discard the catheter operating member.

Republication 2011/1118643

Now, the conventional catheter assembly requires a user to perform a complicated operation, as shown in the procedures (a) to (f) above. Therefore, the catheter assembly is difficult to handle because it takes time for the user to operate, and it is troublesome to discard each component. In addition, when the catheter operating member is detached from the catheter hub, the position of the catheter is displaced, or when the operator holds the catheter hub, bacteria adhere to the catheter hub and the catheter hub is contaminated. It could happen.

The present invention has been made in order to solve the above problems, and a catheter that can be more easily handled by the user by streamlining the operating procedure during use and simplifying the disposal of parts. It is intended to provide an assembly. Another object of the present invention is to provide a catheter assembly that allows a user to remove the catheter operating member from the catheter by a simple operation.

In order to achieve the above object, a catheter assembly according to the present invention has a hollow catheter, a catheter hub for fixing and holding the catheter, and a needle tip, and is detachably inserted into the inside of the catheter. An inner needle, a needle hub that fixes and holds the inner needle, and a catheter operating member that can operate relative movement of the catheter with respect to the inner needle, the catheter operating member having a predetermined distance from the inner needle. while restricting the movement of the above, it has a detachment restricting portion for restricting the disengagement from the needle hub, the catheter operating member, that extends to be in contact with the catheter along the axial direction of said catheter Thus, the bending of the catheter and the inner needle during puncture is suppressed .

According to the above, in the catheter assembly, since the catheter operating member has the separation restricting portion, separation of the catheter operating member from the needle hub can be restricted and the handleability can be improved. That is, since the catheter operating member is connected to the needle hub even at a position where the catheter operating member has moved by a predetermined distance and its movement is restricted, the removed inner needle, needle hub and catheter operating member are collectively discarded when the catheter assembly is used. It becomes possible. Further, as compared with the conventional operation procedure, the operation of discarding the inner needle and the needle hub is omitted, so that the operation procedure is simplified. Further, in the catheter assembly, by exposing the catheter and the catheter hub from the needle hub as the catheter operating member moves, the catheter operating member can be removed from the catheter by a simple operation. Therefore, the user can reduce the trouble and troublesomeness during the operation, and can more easily handle the catheter assembly.

Further, since the catheter operating member extends so as to be able to contact the catheter, it is possible to favorably suppress the bending of the catheter and the inner needle during the catheter advancing operation with respect to the patient, and the catheter can be advanced smoothly. it can.

In addition, the catheter assembly is a second assembly that connects the first assembly including the catheter and the catheter hub, and the inner needle, the needle hub, and the catheter operating member in a state where mutual separation is restricted. And can be separated into

In this way, the catheter assembly is separable into the first assembly and the second assembly, so that the first assembly is placed on the patient side to construct the introduction part, while the second assembly is constructed. Can be easily discarded.

In addition to the above configuration, the catheter hub can be moved between a first state in which it is housed inside the needle hub and a second state in which it is exposed to the outside of the needle hub, by operating the catheter operating member. In the second state, the catheter operating member is preferably separable from the catheter hub.

Accordingly, the user can easily separate the catheter hub from the catheter operating member by setting the catheter hub to the second state during the advancing operation of the catheter operating member.

Further, it is preferable that the catheter operating member accommodates the catheter hub and the needle hub inseparably in the needle hub in the first state.

This allows the user to hold the needle hub of the catheter assembly in the first state and stably puncture the catheter and the inner needle at the time of puncturing, and after the puncturing, attach the catheter and the catheter hub to the inner needle. Can be moved satisfactorily.

Further, the catheter operating member may have an engaging portion that comes into contact with the catheter hub and pushes out the catheter hub when the catheter operating member advances.

Accordingly, the catheter hub can be easily pushed out by the engaging portion when the catheter operating member is advanced. Therefore, in the catheter assembly, it is not necessary to hold the catheter hub by the catheter operating member, and the catheter operating member and the catheter hub can be more easily assembled.

Furthermore, it is preferable that the catheter operating member does not have a holding force that restricts downward movement of the catheter hub with respect to the catheter operating member.

As a result, the catheter hub is allowed to move downward from the catheter operating member. Therefore, when the catheter hub enters the second state when the catheter operating member advances, the catheter hub is more easily detached from the catheter operating member. That is, the catheter assembly can eliminate the operation of removing the catheter operating member from the catheter hub by the user, and can prevent displacement of the catheter, contamination of the catheter hub, and the like.

Here, the second assembly has a safety mechanism that is connected to the needle hub and accommodates the inner needle that has been detached from the catheter so that the inner needle cannot be re-exposed, and the detachment restricting portion includes the catheter operating member. It is preferable that the safety mechanism is connected to the safety mechanism in a state where the disengagement is restricted.

As described above, since the separation of the catheter operating member and the safety mechanism is restricted by the separation restricting portion, the catheter assembly can easily restrict the separation of the catheter operating member while accommodating the inner needle in the safety mechanism. You can

In this case, it is preferable that mutual connection strength between the catheter hub and the safety mechanism is smaller in the second state than in the first state.

In this way, the mutual connection strength between the catheter hub and the safety mechanism is smaller in the second state than in the first state, so that the catheter assembly can be easily detached from the safety mechanism when the catheter hub is advanced. be able to. This also simplifies the separation of the catheter operating member and the catheter hub, making it possible to separate the first assembly and the second assembly more easily.

Further, in the catheter assembly, at least in the second state, the mutual connection strength between the catheter hub and the safety mechanism may be zero.

As described above, since the mutual connection strength between the catheter hub and the safety mechanism becomes zero, the catheter assembly can more easily separate the catheter operating member and the catheter hub.

Further, the separation restricting portion is provided at an extending portion extending in a proximal direction from a hub disposing portion for disposing the catheter hub, and movably engaged with the safety mechanism provided at a proximal end of the extending portion. It is good to include the regulation main body part.

As described above, since the separation restricting portion has the extending portion and the restricting main body portion, the catheter assembly can easily connect the catheter operating member to the predetermined position of the safety mechanism. Then, the catheter operating member can easily pull out the safety mechanism in the distal direction by the user's operation.

Further, the first assembly has an intermediate member connected to a proximal end of the catheter hub, the safety mechanism is connected to the intermediate member in the first state and the intermediate member in the second state. You should disconnect the connection with.

As described above, since the first assembly has the intermediate member, the operation force of the catheter operating member can be transmitted to the catheter hub without directly engaging the catheter operating member with the catheter hub. Further, in the second state, the disconnection of the safety mechanism and the intermediate member allows the first assembly and the second assembly to be easily separated.

Still further, the first assembly has a valve body that is inserted into a proximal end of the catheter hub and projects toward the proximal end, and the safety mechanism is connected to the valve body in the first state, The configuration may be such that the valve body is disconnected in the second state.

As described above, since the first assembly has the valve body, the catheter operating member may not be directly engaged with the catheter hub. Thereby, even when the valve body is provided on the catheter hub, it is possible to prevent the diameter of the catheter assembly itself from increasing.

Alternatively, the separation restricting portion may be configured to connect the catheter operating member to the needle hub in a state in which separation is restricted.

As described above, even if the catheter operating member is connected to the needle hub in a state where the detachment is regulated, the catheter assembly can reliably regulate the detaching of the catheter operating member.

In this case, the separation restricting portion is provided at an extending portion extending in the proximal direction from the hub arrangement portion in which the catheter hub is arranged, and is provided at the proximal end of the extending portion and is locked to the needle hub. It is good to include a regulation main part.

In this way, the separation restricting part has the extending part and the restricting body part, so that the catheter assembly restricts the movement of the catheter operating member at the predetermined position of the needle hub while advancing the catheter operating member. It is possible to prevent separation.

In addition, the extending portion may include a penetrating holding portion through which the inner needle is arranged on the proximal end side of the catheter hub.

In this way, since the extending portion has the penetrating holding portion, it is possible to prevent the catheter operating member from coming off the catheter hub before the inner needle is pulled out from the catheter hub.

Further, the second assembly is preferably capable of retracting the inner needle relative to the needle hub and retracting the inner needle into the needle hub when the second state is changed.

Thus, the second assembly can retract the inner needle relative to the needle hub to accommodate the inner needle in the needle hub, so that the catheter assembly can easily prevent re-exposure of the inner needle. Therefore, the safety at the time of handling (at the time of disposal) can be further enhanced.

According to the present invention, the catheter assembly can be handled more easily by the user by streamlining the operating procedure during use and simplifying the disposal of parts.

It is a perspective view showing the whole catheter assembly composition concerning a 1st embodiment of the present invention. 2 is an exploded perspective view of the catheter assembly of FIG. 1. FIG. 3A is a first partial side view showing the operating procedure of the catheter assembly of FIG. 1, and FIG. 3B is a second partial side view showing the operating procedure of the catheter assembly following FIG. 3A. FIG. 4C is a third partial side view showing the operation procedure of the catheter assembly, following FIG. 3B. 2 is a side sectional view of the catheter assembly of FIG. 1. FIG. 6A is an enlarged perspective view showing the distal end portion of the housing of the catheter assembly of FIG. 1, and FIG. 6B is a perspective view showing the assembly of the proximal end portion of the housing of the catheter assembly of FIG. .. 7A is a plan sectional view showing a safety mechanism of the catheter assembly of FIG. 1, and FIG. 7B is a plan sectional view showing a state where the inner cylinder of FIG. 7A is moved in the distal direction. FIG. 8A is a perspective view of the catheter operating member of the catheter assembly of FIG. 1 as seen from the proximal direction, and FIG. 8B is a perspective view of the catheter operating member as seen from diagonally below. FIG. 3B is a plan view showing a portion of the catheter assembly of FIG. 3A exposed from the housing. FIG. 5 is a perspective view of a state where the indwelling assembly is detached from the catheter operating member of the catheter assembly of FIG. 4, as viewed from the proximal end direction. It is a perspective view showing the whole catheter assembly composition concerning a 2nd embodiment of the present invention. FIG. 12 is a side sectional view showing a safety mechanism of the catheter assembly of FIG. 11. 13A is a perspective view of the catheter operating member of the catheter assembly of FIG. 11 as seen from an obliquely downward direction, and FIG. 13B is a perspective view of the assembled state of the catheter operating member as seen from a proximal direction and an obliquely downward direction. Is. 14A is a first partial side view showing the operating procedure of the catheter assembly of FIG. 11, and FIG. 14B is a second partial side view showing the operating procedure of the catheter assembly following FIG. 14A. 15A is a third partial side view showing the operation procedure of the catheter assembly following FIG. 14B, and FIG. 15B is a fourth partial side view showing the operation procedure of the catheter assembly following FIG. 15A. It is a perspective view showing the whole catheter assembly composition concerning a 3rd embodiment of the present invention. FIG. 17 is a side sectional view showing a safety mechanism of the catheter assembly of FIG. 16. FIG. 18A is a perspective view of the catheter operating member of the catheter assembly of FIG. 16 as seen from an obliquely downward direction, and FIG. 18B is a perspective view of the assembled state of the catheter operating member as seen from a proximal end and an obliquely downward direction. Is. 19A is a first partial side view showing the operating procedure of the catheter assembly of FIG. 16, and FIG. 19B is a second partial side view showing the operating procedure of the catheter assembly following FIG. 19A. FIG. 20A is a side sectional view showing another modified example of the catheter assembly according to the third embodiment, and FIG. 20B is a front sectional view showing yet another modified example of the catheter assembly according to the third embodiment. Is. It is a side sectional view showing the main composition of the catheter assembly concerning a 4th embodiment of the present invention. 22A is a first schematic explanatory diagram showing the operation of the catheter assembly of FIG. 21, FIG. 22B is a second schematic explanatory diagram subsequent to FIG. 22A, and FIG. 22C is a third schematic explanatory diagram subsequent to FIG. 22B. It is a figure. It is a perspective view showing the whole catheter assembly composition concerning a 5th embodiment of the present invention. FIG. 24 is an enlarged perspective view showing a separation restricting portion and a locking mechanism of the catheter assembly of FIG. 23. 25A is a plan view showing the relationship between the supporting member and the catheter operating member of FIG. 23, FIG. 25B is a first partial explanatory view showing the operation of the supporting member, and FIG. 25C is showing the operation of the supporting member. FIG. 25D is a second partial explanatory diagram, and FIG. 25D is a third partial explanatory diagram illustrating the operation of the support member. 26A is a first partial side view showing the operating procedure of the catheter assembly of FIG. 23, and FIG. 26B is a second partial side view showing the operating procedure of the catheter assembly following FIG. 26A. 27A is a first schematic explanatory diagram showing the operation of the catheter assembly according to the modification of the fifth embodiment, FIG. 27B is a second schematic explanatory diagram following FIG. 27A, and FIG. 27C is a schematic diagram of FIG. 27B. It is the 3rd schematic explanatory view following. It is a perspective view which expands and shows the catheter assembly which concerns on 6th Embodiment. 29A is a first partial side view showing the operating procedure of the catheter assembly of FIG. 28, and FIG. 29B is a second partial side view showing the operating procedure of the catheter assembly following FIG. 29A. FIG. 29 is a perspective view of the catheter operating member of the catheter assembly of FIG. 28 as viewed from obliquely below.

Preferred embodiments of the catheter assembly according to the present invention will be described below in detail with reference to the accompanying drawings.

INDUSTRIAL APPLICABILITY The catheter assembly according to the present invention is used for puncturing and indwelling a patient (living body) in the body of a patient (living body) to construct an introduction portion for a drug solution or the like. The catheter assembly may be configured as a catheter that is longer than the peripheral venous catheter (eg, central venous catheter, PICC, midline catheter, etc.). It should be noted that the catheter assembly may be configured as a peripheral vein catheter. The catheter assembly is not limited to the venous catheter and may be configured as an arterial catheter such as a peripheral arterial catheter.

[First Embodiment]
As shown in FIGS. 1 and 2, the catheter assembly 10</b>A according to the first embodiment includes a catheter 12, a catheter hub 14 that holds the catheter 12 in a fixed manner, an inner needle 16 that is inserted into the catheter 12, and an inner needle 16. And a housing 20 (needle hub) that holds the needle 16 fixedly. Further, the catheter assembly 10A includes a safety mechanism 40 connected to the catheter hub 14, and a catheter operating member 60 that moves the catheter 12 relative to the inner needle 16.

The catheter assembly 10A has a multi-tube structure (multi-tube portion 18) in which the catheter 12 and the inner needle 16 are sequentially stacked from the outside in an initial state before use. Further, in the catheter assembly 10A, in the initial state, the proximal end portion of the multi-tube portion 18, the catheter hub 14, the catheter operating member 60, and the safety mechanism 40 are properly assembled and housed in the housing 20.

When used, a user such as a doctor or a nurse holds the housing 20 of the catheter assembly 10A in the initial state (puncturable state: first state) shown in FIG. Puncture into a vein or artery. While maintaining this punctured state, the user relatively advances the catheter operating member 60 holding the catheter 12 with respect to the inner needle 16 and the housing 20 to move the catheter 12 distal to the inner needle 16 (the blood vessel). To the inner part of).

In the catheter assembly 10A, as the catheter operating member 60 advances, the catheter hub 14 and the safety mechanism 40 connected to the catheter operating member 60 also move integrally as shown in FIG. 3A. Further, the catheter operating member 60 is bent by the user so as to be separated from the inner needle 16 while advancing (see the chain double-dashed line in FIG. 3A), thereby releasing the holding of the multi-tube portion 18.

When the safety mechanism 40 comes out of the tip of the housing 20 and advances to some extent, the needle tip 16a of the inner needle 16 is accommodated in the safety mechanism 40 as shown in FIG. 3B. Further, the catheter operating member 60 advances a relatively short distance from the safety mechanism 40. As a result, the catheter 12 and the catheter hub 14 can be separated from the catheter operating member 60 and the safety mechanism 40 as shown in FIG. 4, and the catheter hub 14 is separated from the catheter operating member 60. Then, the catheter 12 and the catheter hub 14 are left on the patient side. Hereinafter, the catheter assembly 10A will be specifically described.

As shown in FIG. 2, the catheter 12 of the catheter assembly 10A has an appropriate flexibility and includes a lumen 12a penetrating the inside thereof along the axial direction. The inner cavity 12a is formed to have a diameter capable of accommodating the inner needle 16 and allowing a medicinal solution, blood or the like to flow. The length of the catheter 12 is not particularly limited and can be appropriately designed according to the application and various conditions, for example, set to about 14 to 500 mm, about 30 to 400 mm, or about 76 to 200 mm. Is set.

The constituent material of the catheter 12 is not particularly limited, but a soft resin material is suitable, and examples thereof include polytetrafluoroethylene (PTFE), ethylene/tetrafluoroethylene copolymer (ETFE), and perfluoroalkoxy fluororesin. Fluorine resins such as (PFA), olefin resins such as polyethylene and polypropylene, or mixtures thereof, polyurethane, polyester, polyamide, polyether nylon resins, mixtures of olefin resins and ethylene/vinyl acetate copolymers, and the like. To be

The proximal end portion of the catheter 12 is fixed to the distal end portion inside the catheter hub 14 by an appropriate fixing method such as caulking, fusion bonding, or adhesion. The catheter hub 14 is exposed on the skin of the patient in a state where the catheter 12 is inserted into the blood vessel of the patient, and is affixed with a tape or the like to be indwelled together with the catheter 12.

The catheter hub 14 is formed in a tubular shape that tapers in the distal direction. As shown in FIG. 5, inside the catheter hub 14, a hollow portion 14a that communicates with the inner cavity 12a of the catheter 12 and allows the infusion agent to flow therethrough is provided. A flange 15 is formed on the outer peripheral surface on the proximal end side of the catheter hub 14 so as to project radially outward of the catheter hub 14 and circulate in the circumferential direction. A connector of a syringe or an infusion tube (not shown) is connected to the proximal end of the catheter hub 14 after the inner needle 16 is detached.

Further, in the hollow portion 14a of the catheter hub 14, a hemostatic valve (not shown) that prevents backflow of blood when the inner needle 16 is punctured, and a hemostatic valve (not shown) that allows transfusion with the insertion of a connector of an infusion tube (not shown). A plug or the like may be housed.

The constituent material of the catheter hub 14 is not particularly limited, but for example, a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, or methacrylate-butylene-styrene copolymer may be applied.

On the other hand, the inner needle 16 of the catheter assembly 10A is configured as a hollow tube having rigidity capable of piercing the skin of a living body, and is penetrated through the inner cavity 12a of the catheter 12 and the hollow portion 14a of the catheter hub 14. The inner needle 16 has a total length longer than that of the catheter 12, a sharp needle tip 16a is provided at the tip thereof, and a through hole 16b is provided inside thereof along the axial direction. In the initial state shown in FIG. 1, the inner needle 16 constitutes a multi-tube portion 18 in which the needle tip 16a is exposed from the catheter 12. The outer peripheral surface of the inner needle 16 may be provided with a groove by cutting a part thereof along the axial direction. The inner needle 16 may be provided with a lateral hole. Further, the inner needle 16 may be a solid needle.

Examples of the constituent material of the inner needle 16 include metal materials such as stainless steel, aluminum or aluminum alloys, titanium or titanium alloys, hard resins, and ceramics. The inner needle 16 is firmly fixed to the needle holding member 25 of the housing 20 by an appropriate fixing method (fusing, bonding, insert molding, etc.).

As shown in FIG. 2, the housing 20 has a lower wall 21 and a pair of side walls 22 and 23 projecting upward from both sides of the lower wall 21, and an elongated space in which a housing space 20a is formed. It is shaped like a bowl. The resin material forming the housing 20 is not particularly limited, and for example, the materials mentioned for the catheter hub 14 can be appropriately selected. In this catheter assembly 10A, the catheter operating member 60 and the safety mechanism 40 are exposed on the upper side. Alternatively, the catheter assembly 10A may have a configuration in which the housing 20 has an upper wall formed or a lid is attached to cover the catheter operating member 60, the safety mechanism 40, and the like.

As shown in FIGS. 6A and 6B, the lower wall 21 is sandwiched between a pair of flat side portions 21a, 21a and a pair of side portions 21a, 21a, and has a downward arc shape. It has a recessed guide groove portion 24. The guide groove portion 24 arranges the catheter hub 14 and the safety mechanism 40 slidably along the longitudinal direction of the housing 20. The guide groove 24 on the proximal end side of the lower wall 21 is provided with a mounting hole 24a into which a needle holding member 25 holding the inner needle 16 is mounted.

As shown in FIGS. 2 and 6B, the needle holding member 25 includes a holding base portion 26 in the widthwise central portion, a hook-shaped connecting portion 27 protruding below the holding base portion 26, and both sides of the holding base portion 26 on the lower side thereof. It has a pair of support reinforcement pieces 28 and 28 which respectively project from the surface to the width direction outside. A holding hole 26 a extending in parallel to the axial direction of the housing 20 is formed through the upper part of the holding base 26. The inner needle 16 is inserted into the holding hole 26a and fixed by an appropriate fixing means such as welding or adhesion. The hook-shaped connecting portion 27 is inserted into the mounting hole 24a and hooked on the housing 20 to firmly fix the needle holding member 25 to the housing 20.

Further, the support reinforcing piece 28 has a horizontal plate 28a connected to the holding base portion 26 and a vertical plate 28b protruding upward from a protruding end of the horizontal plate 28a. When the hook-shaped connecting portion 27 is fixed to the housing 20, the horizontal plate 28a is supported in contact with the pair of side portions 21a, 21a, and the vertical plate 28b is fixed in contact with the inner surfaces of the pair of side walls 22, 23. As a result, the needle holding member 25 is prevented from moving with respect to the housing 20, and the inner needle 16 can be held satisfactorily. The needle holding member 25 may be integrally formed with the housing 20.

The pair of side walls 22 and 23 extend in parallel with the lower wall 21 in the longitudinal direction, have a constant vertical height on the base end side and the intermediate side, and have a wide vertical height on the front end side with respect to the intermediate side. There is. Groove-shaped rail portions 29 are provided on the upper ends of the side walls 22 and 23, respectively. The pair of rail portions 29, 29 are continuous with an open portion 29a formed at the upper end of each side wall 22, 23 on the tip side, and further extend linearly on the inner surface of each side wall 22, 23 toward the proximal direction. It is connected to the upper surface of the intermediate portion in the extending direction. The pair of rail portions 29, 29 accommodate the side edges of the catheter operating member 60 and guide the catheter operating member 60 forward and backward. Further, the opening portion 29a is notched on the upper side of the housing 20 to allow the catheter operating member 60 to bend.

Further, the one side wall 22 has a bulging portion 22a bulging outward in the width direction, and the bulging portion 22a is provided with a placement recess 22b for mounting the support member 30. The placement recess 22b is cut out from the tip of the side wall 22 toward the base end and is located between the lower wall 21 and the rail portion 29. A pair of upper and lower bearing holes 22c (see FIG. 2) for rotatably mounting the support member 30 are provided on the lower wall 21 and the side wall 22 where the placement recess 22b is formed.

As shown in FIG. 6A, the support member 30 is attached to support the lower side of the catheter 12 (multi-tube portion 18) held by the catheter operating member 60. The support member 30 includes a shaft rod portion 31 rotatably attached to the pair of support hole portions 22c, 22c of the placement recess 22b, a support body 32 projecting in a direction orthogonal to the axis of the shaft rod portion 31, and a shaft. It has an upper protrusion 33 provided at the upper end of the rod portion 31.

The support body 32 is formed in a crank shape when viewed from the front, and supports the catheter 12 with an appropriate elasticity. The upper protrusion 33 has a guide recess 33a that is continuous with the rail portion 29 on the inner side in the width direction, and the side edge of the catheter operating member 60 is arranged in the guide recess 33a in a puncturable state.

The support main body 32 is positioned inside the side wall 22, that is, below the catheter 12, by the shaft rod portion 31 and stands by so that the catheter 12 can be supported while the catheter operating member 60 is accommodated in the housing 20. As a result, when a downward pressing force is applied to the catheter operating member 60 by the user, the support body 32 supports the catheter 12 downward and suppresses the bending of the catheter 12. On the other hand, when the catheter operating member 60 comes out of the housing 20, the support body 32 is rotated toward the outside of the side wall 22 based on the shape of the catheter operating member 60. As a result, the support member 30 causes the catheter hub 14, the catheter operating member 60, and the safety mechanism 40 to be smoothly delivered from the housing 20.

On the other hand, the safety mechanism 40 has the inner needle 16 penetratingly arranged in the initial state. When the catheter 12 and the inner needle 16 are detached, the needle tip 16a that has moved is housed inside to prevent the needle tip 16a from being re-exposed. As shown in FIGS. 2 and 5, the safety mechanism 40 has an inner cylinder 41 that is wide in the up-down direction and narrow in the left-right direction as a whole and that covers the needle tip 16 a of the inner needle 16, The inner cylinder 41 is configured with an outer cylinder 50 into which the inner cylinder 41 is relatively movably inserted. The safety mechanism 40 moves to a position where the needle tip 16a of the inner needle 16 is accommodated by the inner cylinder 41 moving relative to the outer cylinder 50 and the outer cylinder 50 moving relative to the inner needle 16 and the housing 20.

The inner cylinder 41 is in a puncturable state, and its distal end portion is located at a base end position with respect to the distal end of the outer cylinder 50, and is displaced so as to project from the distal end of the outer cylinder 50 as the inner needle 16 is removed. The inner cylinder 41 includes a box body 42, a head portion 43 projecting from the box body 42 in a tip direction, a pair of arms 44 and 44 integrally formed on a side surface of the box body 42, and a proximal direction from the box body 42. And an inner cylindrical portion 45 protruding to the inside. As shown in FIGS. 7A and 7B, an insertion hole 46 through which the inner needle 16 is inserted is formed inside the box body 42, the head portion 43, and the inner tubular portion 45.

The box 42 has a rectangular shape that is long in the vertical direction and short in the width direction, and is formed in a size that can be housed in the housing of the outer cylinder 50. Inside the box 42, a cavity 42 a is formed by slightly expanding the insertion hole 46. A shutter 47 is provided in the cavity 42a to prevent the needle tip 16a from being re-exposed. Further, the head portion 43 provided on the tip end surface of the box body 42 is inserted into the hollow portion 14a from the base end of the catheter hub 14 to fit the catheter hub 14 with a predetermined connection strength.

The shutter 47 is formed in a U shape in a plan sectional view, and is configured as a leaf spring having a left and right width that matches the width of the cavity 42a. The shutter 47 is accommodated in a state in which the inner needle 16 penetrates the cavity 42a and is elastically deformed in the space above the inner needle 16, and the U-shaped curved portion and the end portion on the opposite side are close to each other. There is. When the inner needle 16 retracts in the proximal direction, the end portion of the shutter 47 that was in contact with the inner needle 16 elastically restores and opens below the cavity 42a. As a result, the shutter 47 planarly faces the needle tip 16a of the inner needle 16 in the cavity 42a, and prevents the inner needle 16 from being re-exposed.

The pair of arms 44, 44 are connected to the side surfaces of the box body 42 in the vertical direction, and extend in the tip direction above and below the box body 42 along the axial direction of the inner cylinder 41. The arms 44, 44 are formed such that, in a natural state in which an external force does not act, the extending direction front end portion expands outside the width direction of the outer cylinder 50. Then, the distal end in the extending direction is elastically pressed by the side wall of the outer cylinder 50 toward the inner side in a puncturable state (in a state where the inner cylinder 41 and the outer cylinder 50 overlap each other).

Hooks 44a that project inward in the width direction are provided inside the pair of extending direction distal ends, and these hooks 44a are hooked on the flange 15 of the catheter hub 14 by approaching the inside in a puncturable state. As a result, the inner cylinder 41 sandwiches the catheter hub 14 between the head portion 43 inserted on the proximal end side of the catheter hub 14 and the pair of hooks 44a, 44a to firmly connect and hold the catheter hub 14. When the inner cylinder 41 is displaced toward the distal end side of the outer cylinder 50, the distal end portion in the extending direction elastically expands, and the hooking of the flange 15 by the pair of hooks 44a, 44a is released. As a result, disengagement from the catheter hub 14 is allowed.

The inner cylinder portion 45 of the inner cylinder 41 is formed into a cylindrical shape that can be housed in the outer cylinder side hollow portion 54 of the outer cylinder 50. As shown in FIGS. 7A and 7B, the inner cylinder 41 and the outer cylinder 50 are prevented from being separated from each other in a puncturable state at the distal end side of the inner cylinder part 45 (the connection part between the box body 42 and the inner cylinder part 45). An allowable space 45a is provided which is in communication with the stopper portion 48 and the insertion hole 46 and in which the stopper portion 48 is displaceably arranged.

Further, an inner protrusion 49 is provided on the outer peripheral surface of the inner cylindrical portion 45 closer to the base end than the stopper portion 48. The inner protrusion 49 is inserted into the long hole 52a of the outer cylinder 50 and regulates relative displacement of the inner cylinder 41 and the outer cylinder 50 more than a predetermined amount when the inner cylinder 41 and the outer cylinder 50 move relatively to each other. 41 is prevented from completely coming off the outer cylinder 50.

On the other hand, as shown in FIGS. 2, 5, 7A, and 7B, the outer cylinder 50 includes a container 51 and an outer cylinder portion 52 extending from the container 51 in the proximal direction. The housing 51 has substantially the same shape as the box 42 and is formed to be slightly larger than the box 42, and the housing 51 a is provided inside thereof. The housing portion 51a is opened laterally so that one side portion (right side portion in FIG. 2) and the tip portion are integrally connected. In the puncturable state, the proximal end of the catheter hub 14 and the distal end side of the inner cylinder 41 (the pair of arms 44, 44, the box 42, etc.) are arranged in the accommodation portion 51a. In addition, a concave groove 53 that extends parallel to the axial direction of the outer cylinder 50 and into which the arm 44 is slidably inserted is provided on each inner surface of the housing 51 in the vertical direction.

The outer cylinder portion 52 is formed to be longer than the inner cylinder portion 45 of the inner cylinder 41, and includes an outer cylinder side hollow portion 54 that is formed to penetrate along the axial direction. A long hole 52a communicating with the outer cylinder side hollow portion 54 is formed on the outer peripheral surface of the outer cylinder portion 52 on the tip side. A proximal end flange portion 55 is provided on the outer peripheral surface of the outer tubular portion 52 on the proximal end side to prevent the detachment restricting portion 63 of the catheter operating member 60, which will be described later, from coming off in the proximal direction.

Further, a base end wall 56 that substantially closes the outer cylinder side hollow portion 54 is provided on the base end side of the outer cylinder portion 52. The proximal end wall 56 is provided with a mouth portion 56 a through which the inner needle 16 can be disposed so as to substantially match the outer diameter of the inner needle 16. The proximal wall 56 that constitutes the mouth portion 56a has a retaining function that prevents the inner needle 16 from coming off together with the inner needle 16.

That is, as shown in FIG. 7B, the inner needle 16 according to the present embodiment has a needle-side protrusion 16c on the outer peripheral surface near the needle tip 16a, which projects radially outward from the outer diameter of the other portion. The needle-side protrusion 16c has an outer diameter capable of passing through the inner cavity 12a of the catheter 12, but is formed larger than the inner diameter of the mouth portion 56a. Therefore, when the inner needle 16 is moved backward toward the base end side, the needle side projection 16c is caught by the base end wall 56 forming the mouth portion 56a, and the inner needle 16 is prevented from coming off from the safety mechanism 40.

As shown in FIG. 7A, the safety mechanism 40 having the inner cylinder 41 and the outer cylinder 50 described above can be punctured by the inner needle 16 penetratingly arranged in the insertion hole 46 (allowable space 45a) of the inner cylinder 41. The stopper portion 48 is arranged in the long hole 52a of the outer cylinder 50 to prevent the stopper portion 48 from being displaced inward. Therefore, the stopper portion 48 is caught by the outer cylinder 50, and restricts the relative movement of the inner cylinder 41 with respect to the outer cylinder 50. Therefore, the safety mechanism 40 can integrally move the inner cylinder 41 and the outer cylinder 50 relative to the inner needle 16 and the housing 20.

On the other hand, in the safety mechanism 40, as the needle tip 16a of the inner needle 16 moves toward the base end side of the stopper portion 48, the stopper portion 48 becomes movable in the allowable space 45a as shown in FIG. 7B. .. Therefore, the inner cylinder 41 becomes movable relative to the outer cylinder 50, and when the inner cylinder 41 advances, the stopper portion 48 pushed by the outer cylinder 50 is arranged in the insertion hole 46 through the allowance space 45a. By further advancing the inner cylinder 41, as shown in FIG. 4, the pair of arms 44, 44 are exposed from the housing body 51 of the outer cylinder 50 to allow the catheter hub 14 to be detached.

As shown in FIGS. 2 and 5, the catheter operating member 60 of the catheter assembly 10</b>A directly holds the catheter 12 and is attached to the catheter hub 14, so that the catheter 12 and the catheter 20 are attached to the inner needle 16 and the housing 20. The hub 14 is moved back and forth relatively. The catheter operating member 60 includes an operating plate portion 61 extending in the longitudinal direction of the housing 20, and a hub storing portion 62 (hub arrangement portion) connected to the base end of the operating plate portion 61 to detachably store the catheter hub 14. A detachment restricting portion 63 that extends from the hub accommodating portion 62 in the proximal direction and is attached to the safety mechanism 40 is provided.

The operation plate portion 61 is a portion on which a user's finger is applied to perform an advancing/retreating operation. In the initial state, the pair of side edges of the operation plate portion 61 are arranged on the pair of rail portions 29, 29 and the upper surfaces of the pair of side walls 22, 23. The operation plate portion 61 is formed to be sufficiently thin so that it has the flexibility to bend in the direction orthogonal to the surface direction of the operation plate portion 61, that is, in the direction away from the inner needle 16. The material forming the operation plate portion 61 (catheter operation member 60) is not particularly limited, and for example, the materials mentioned for the catheter hub 14 can be appropriately selected. The portion extending along the catheter 12 is not limited to a plate shape, and various configurations (for example, a rod shape) may be applied.

As shown in FIG. 8A, an upper rib 61 a and a tab 61 b are provided on the upper surface of the operation plate portion 61, a tip warp portion 64 is provided at the tip of the operation plate portion 61, and a lower surface of the operation plate portion 61 is provided. Is provided with a holding portion 65 and a lower rib 61c. A plurality of the upper ribs 61a and the lower ribs 61c are provided along the longitudinal direction and extend in the lateral direction (width direction) of the operation plate portion 61, thereby increasing the strength of the operation plate portion 61 in the width direction. I am raising.

As shown in FIG. 8B, the tip warp portion 64 has a thick portion that protrudes to the lower surface side of the operation plate portion 61, and becomes thinner from the thick portion toward the tip direction and bends upward. doing. An insertion groove 64a, through which the catheter 12 is passed in a non-contact or weak frictional force, is formed in the widthwise central portion of the thick portion. As the catheter operation member 60 advances, the tip warp portion 64 guides the operation plate portion 61 obliquely upward by contacting the patient with the warped lower surface side or by being gripped by the user.

On the other hand, one or more (three in FIG. 8B) holding portions 65 of the catheter operating member 60 are provided along the longitudinal direction of the operating plate portion 61. The holding portions 65 are arranged at equal intervals in the longitudinal direction of the operation plate portion 61, and hold the outer circumferential surface of the catheter 12 in contact with each other at each position. Each holding portion 65 has a pair of projecting pieces 65a and 65b projecting downward from the lower surface of the operation plate portion 61.

The pair of protrusions 65a and 65b are formed symmetrically to each other with the widthwise intermediate portion of the operation plate portion 61 interposed therebetween. The pair of protrusions 65a and 65b are formed in a rectangular shape that is wide in the width direction of the operation plate portion 61, and each inner edge facing the catheter 12 is set to have a space slightly wider than the outer diameter of the catheter 12. .. On the lower side of each inner edge, there is provided a claw portion that slightly protrudes inward in the width direction and is set at an interval slightly smaller than the outer diameter of the catheter 12.

When the catheter 12 is assembled with the catheter operating member 60, the catheter 12 is retained by being hooked on the pair of claws and held between the pair of projecting pieces 65a and 65b. Further, as shown in FIG. 8B, the pair of projecting pieces 65 a and 65 b are formed to project along the longitudinal direction of the operation plate portion 61 so that their phases (formation positions) are displaced from each other. That is, the holding portion 65 holds the catheter 12 with a weak engagement force by not sandwiching the catheter 12 coaxially. Therefore, the catheter operating member 60 can be removed at a timing when the pair of protrusions 65a and 65b disengage the catheter 12 when the operating plate 61 bends. The configuration of the holding portion 65 is not particularly limited, and may be a groove or a recess formed on the lower surface of the operation plate portion 61 itself or a projection protruding from the lower surface.

On the other hand, the hub accommodating portion 62 of the catheter operating member 60 includes a pair of side plates 66, 66 projecting downward from the operating plate 61, and a semi-cylindrical upper plate 67 projecting slightly upward from the operating plate 61. Is formed into a dome shape. The base end side and the intermediate side of the pair of side plates 66, 66 extend parallel to the side wall of the housing 20. The tip end side of the pair of side plates 66, 66 is triangular in the tip end direction by inclining inward in the tip end direction with respect to the middle side.

A storage chamber 62a for rotatably storing the catheter hub 14 is provided inside the pair of side plates 66, 66 and the upper plate 67. The storage chamber 62a is open to the outside at the bottom and the base end. Further, in the present embodiment, the hub accommodating portion 62 merely arranges the catheter hub 14 in the accommodating chamber 62a, and has a holding force that restricts the downward movement of the catheter hub 14 with respect to the catheter operating member 60. Not not. The operating force at the time of advancing the catheter operating member 60 is transmitted to the catheter hub 14 by the safety mechanism 40 and the hub engaging portion 69 described later, and the operating force at the time of retreating is applied to the catheter hub 14 by the pair of side plates 66, 66. Transmitted.

Further, as shown in FIG. 8A, the separation restricting portion 63 is connected to one side plate 66 of the pair of side plates 66 of the hub accommodating portion 62. The disengagement restricting portion 63 includes an extending portion 68 extending from the side plate 66 in the proximal direction, a hub engaging portion 69 provided on a side surface of the extending portion 68, and a restricting body portion provided at a proximal end of the extending portion 68. 70 and.

The extension portion 68 has a length in the extension direction set to a length corresponding to the entire length of the outer cylinder 50 of the safety mechanism 40, and in the puncturable state, the base end is the base end of the outer cylinder portion 52 ( It contacts the base end flange portion 55). Further, the vertical width of the extending portion 68 is set to be the same as the vertical width of the side plate 66. That is, since the side plate 66 has an appearance in which the side plate 66 extends linearly long, the separation restricting portion 63 secures the rigidity of the separation restricting portion 63 itself.

The hub engaging portion 69 is formed so as to project toward the inner side in the width direction (extension line of the axis of the hub accommodating portion 62) at an intermediate position of the extending portion 68 (close to the base end of the hub accommodating portion 62). The hub engaging portion 69 makes it possible to integrally move the catheter hub 14 during the advancing operation of the catheter operating member 60 by contacting the flange 15 of the catheter hub 14 housed in the hub housing portion 62. The hub engaging portion 69 is formed in a block shape having a predetermined length in the longitudinal direction of the extending portion 68. As a result, in the puncturable state, the protruding surface contacts the inner cylinder 41 of the safety mechanism 40 to stabilize the posture of the extending portion 68.

When viewed from the front, the restricting main body portion 70 is connected to the base end of the extending portion 68 and the connecting portion 71. The restricting main body portion 70 is connected to the connecting portion 71 and projects inward in the width direction orthogonal to the longitudinal direction of the extending portion 68. And a locking rod portion 72 having a C shape. Inside the locking rod portion 72, a locking space 73 having a diameter slightly larger than the outer diameter of the outer cylindrical portion 52 of the outer cylinder 50 is formed. Therefore, the locking rod portion 72 is slidably locked to the outer peripheral surface of the outer tubular portion 52. The connecting part 71 slightly protrudes inward in the width direction so that the posture of the extending part 68 is along the axial direction of the safety mechanism 40 while locking the locking rod part 72 to the outer tubular part 52.

The locking rod portion 72 has a communication gap 72 a communicating with the locking space 73 on the opposite side of the connecting portion 71. The pair of projecting end portions of the locking rod portion 72 forming the communication gap 72a are separated by an appropriate width narrower than the outer diameter of the outer tubular portion 52 (for example, 80% or less of the outer diameter of the outer tubular portion 52). ing. Further, the locking rod portion 72 is formed in a rectangular cross section having four end faces in the direction along the axial direction of the outer tubular portion 52 and the direction along the radial direction of the outer tubular portion 52. As a result, during assembly, the regulation body portion 70 is twisted so that the pair of projecting end portions are separated from each other along the axial direction of the outer tubular portion 52, so that the outer tubular portion is inserted into the locking space 73 through the communication gap 72a. It is possible to guide 52. On the other hand, the locking rod portion 72 has a structure that exerts sufficient rigidity in the radial direction in a state where it is exteriorly mounted on the outer tubular portion 52 and cannot be easily removed from the outer tubular portion 52. The locking rod portion 72 may be formed in another cross-sectional shape.

In the catheter assembly 10A having the above-described configuration, the disengagement restricting portion 63 of the catheter operating member 60 is relatively slidable with respect to the outer tubular portion 52 of the outer barrel 50 in the assembled state (pierceable state) shown in FIG. Is locked to. Further, the outer cylinder side hollow portion 54 of the outer cylinder portion 52 accommodates the inner cylinder 41 such that the inner cylinder 41 can move forward and backward, and the head 43 of the inner cylinder 41 holds the proximal end of the catheter hub 14. (See also Figure 7A). Further, since the distal end portion of the catheter hub 14 is housed in the hub housing portion 62 of the catheter operating member 60 and the hub engaging portion 69 is arranged on the proximal end side of the catheter hub 14, the safety mechanism 40, the catheter operating The member 60 and the catheter hub 14 can be moved integrally.

The catheter operating member 60 holds the catheter 12 with an appropriate holding force by holding the catheter 12 in the holding portion 65 of the operating plate portion 61. The inner needle 16 is inserted through each of the components assembled in this way to form a multi-tube portion 18 with the catheter 12, and the components are integrally housed in the housing space 20a of the housing 20. Further, in the puncturable state, the operation plate portion 61 of the catheter operation member 60 is arranged on the upper surfaces of the pair of side walls 22 and 23 of the housing 20 and the rail portion 29, and the linearity is maintained. Further, at the tip of the housing 20, the support member 30 supports the lower side of the multiple pipe section 18. Therefore, the multi-tube portion 18 is favorably held in the housing 20 in a linearly extended state.

The catheter assembly 10A according to the first embodiment is basically configured as described above, and its function and effect will be described below.

As described above, the catheter assembly 10A is used when constructing a portion for introducing an infusion solution into a patient. In the use of the catheter assembly 10A, the user grips the housing 20 to puncture the patient with the multi-tube portion 18 (puncture operation). At the time of puncturing, the holding portion 65 holds the catheter 12 and the support member 30 supports the catheter 12, thereby preventing the multi-tube portion 18 from bending.

In the punctured state of the multi-tube portion 18, the user advances the catheter 12 relative to the inner needle 16 and inserts it into the blood vessel (catheter advancing operation). At this time, the user slides the catheter operating member 60 relative to the housing 20 in the distal direction by putting his/her finger on the upper rib 61a or the tab 61b of the catheter operating member 60. As a result, as shown in FIG. 3A, the operation plate portion 61 of the catheter operation member 60 causes the tip warp portion 64 to come into contact with the skin or the like of the patient as the tip tip direction advances, or the user grips the tip warp portion 64. By doing so, the multi-tube portion 18 is bent so as to be far from the axial direction. As a result, each holding unit 65 sequentially removes the multi-tube unit 18.

Further, with the advancement of the catheter operating member 60, the catheter hub 14 and the safety mechanism 40 also advance integrally. Then, the catheter operating member 60 rotates the support member 30 to the outside of the housing 20 when the side plate 66 comes into contact with the support member 30 when exiting the housing 20. As a result, the catheter operating member 60, the catheter hub 14, and the safety mechanism 40 come out of the tip of the housing 20 and are exposed to the outside.

After sufficiently advancing the catheter 12 into the blood vessel, the user pulls out the inner needle 16 and the housing 20 in the proximal direction to remove the inner needle 16 from the patient while the catheter 12 is still inserted (inner needle retracting operation). ). Further, the user retreats the inner needle 16 and the housing 20 relative to the catheter operating member 60, the catheter hub 14, and the safety mechanism 40 so as to separate from the catheter hub 14.

At the time of this inner needle retracting operation, the safety mechanism 40 allows the inner needle 16 to retract toward the base end side of the stopper portion 48, thereby allowing the stopper portion 48 to move into the allowance space 45a (see FIGS. 7A and 7B). ). Then, the inner needle 16 is continuously accommodated in the safety mechanism 40 as the needle side projection 16c is hooked on the proximal end wall 56 of the outer cylinder 50. In the safety mechanism 40, the stopper portion 48 or the shutter 47 is deployed in front of the needle tip 16a to prevent re-exposure of the needle tip 16a.

On the other hand, the inner cylinder 41 can advance in the distal direction with respect to the outer cylinder 50 because the stopper 48 does not engage the outer cylinder 50. Further, the detachment restricting portion 63 of the catheter operating member 60 is slidable relative to the outer cylinder 50. Therefore, as shown in FIG. 3B, as the outer cylinder 50 retreats, the catheter hub 14, the catheter operating member 60, and the inner cylinder 41 integrally advance, and the box 42 is exposed from the tip of the outer cylinder 50. Then, at the stage where the inner protrusion 49 of the inner cylinder 41 is caught by the housing 51 of the outer cylinder 50 (see FIG. 7B), the pair of arms 44, 44 is sufficiently exposed and the engagement of the catheter hub 14 is released. To do. As a result, the catheter hub 14 shifts to the second state in which only the engagement with the head portion 43 of the inner cylinder 41 is performed. That is, in the puncturable state, the catheter hub 14 and the safety mechanism 40 that are connected with a strong connection strength have a weak connection strength that allows the catheter hub 14 to be detached after the inner needle retracting operation.

The catheter operating member 60 can be advanced slightly beyond the inner cylinder 41 while the detachment restricting portion 63 remains locked to the outer cylinder 50, and the catheter hub 14 is pulled out from the head portion 43 of the inner cylinder 41 with this advance. Allow (leave operation). As a result, the catheter hub 14 can be separated from the hub accommodating portion 62 of the catheter operating member 60, and the indwelling assembly 19 (first assembly) including the catheter 12 and the catheter hub 14 can be indwelled well in the patient at an appropriate timing. To be done.

On the other hand, the inner needle 16, the housing 20, the safety mechanism 40, and the catheter operating member 60, which are separated from the catheter 12 and the catheter hub 14, are a continuous disposal planned assembly 80 (second assembly). .. That is, a group of discarded components is handled as one unit by being locked (disengagement is regulated) by the safety mechanism 40 at a position moved by a predetermined distance with respect to the catheter operating member 60 and the inner needle 16. be able to. In addition, at this time, the safety mechanism 40 protects the inner needle 16 to prevent erroneous sticking to the user or the like. Therefore, the user can efficiently and safely dispose of the scheduled disposal assembly 80 by the disposal operation.

Therefore, the operations of the catheter assembly 10A by the user are summarized as follows: (A) puncturing operation, (B) catheter advancing operation, (C) inner needle retracting operation, (D) detaching operation, and (E) discarding operation procedure. Become.

As described above, in the catheter assembly 10A according to the first embodiment, since the catheter operating member 60 has the detachment restricting portion 63, the catheter operating member 60 is prevented from being detached from the housing 20, and the handleability is improved. Can be made. That is, since the catheter operating member 60 is moved by a predetermined distance and is connected to the housing 20 even at a position where the movement is restricted, when the catheter assembly 10A is used, the removed inner needle 16, the housing 20, the safety mechanism 40, and the catheter are used. It is possible to collectively discard the operating members 60. Further, as compared with the conventional operation procedure, the operation of discarding the inner needle 16 and the housing 20 first is omitted, so that the operation procedure is simplified. Therefore, the user can reduce the labor and trouble during the operation, and can more easily handle the catheter assembly 10A.

In this case, the catheter assembly 10A can be separated into the first assembly (the catheter 12 and the catheter hub 14) and the second assembly (the scheduled disposal assembly 80), so that the first assembly is placed on the patient side. On the other hand, the to-be-discarded assembly 80 can be easily discarded. In addition to this, by continuing the connection between the catheter operating member 60 and the safety mechanism 40 by the detachment restricting portion 63, the catheter assembly 10A stores the inner needle 16 in the safety mechanism 40 and detaches the catheter operating member 60. Can be regulated. Further, since the mutual connection strength between the catheter hub 14 and the safety mechanism 40 is smaller in the second state after the inner needle retracting operation than in the puncturable state (first state), the catheter hub 14 is separated from the safety mechanism 40. Can be removed by a simple operation. This also simplifies the separation of the catheter operating member 60 and the catheter hub 14.

Further, the user can stably puncture the catheter 12 and the inner needle 16 by grasping the housing 20 in which the catheter hub 14 is housed during the puncture, and after the puncture, the catheter 12 and the catheter hub 14 can be punctured. Can be moved satisfactorily. On the other hand, in the advancing operation of the catheter operating member 60, the catheter hub 14 can be easily separated from the catheter operating member 60 by setting the catheter hub 14 to the second state with the housing 20 exposed.

Further, since the separation restricting portion 63 has the extending portion 68 and the restricting body portion 70, the catheter assembly 10A can easily connect the catheter operating member 60 to the predetermined position of the safety mechanism 40. Then, the catheter operating member 60 can easily pull out the safety mechanism 40 in the distal direction by a user's operation. Further, since the detachment restricting portion 63 has the hub engaging portion 69, the catheter operating member 60 assists the catheter hub 14 in advancing during the advancing operation of the catheter operating member 60, thereby making the operation even more stable. Can be implemented.

It should be noted that the catheter assembly 10A is not limited to the configuration described above, and various modifications and applications can be adopted. For example, the catheter operating member 60 of the catheter assembly 10A may be configured such that the separation restricting portion 63 does not include the hub engaging portion 69 and the catheter hub 14 is engaged in the hub housing portion 62 or the like. Specifically, by forming a U-shaped groove on the inner surface of the hub housing portion 62 and providing an annular projection on the outer surface of the catheter hub 14, the catheter hub 14 and the catheter operating member 60 are formed. Can be moved integrally. On the other hand, by pulling the catheter operating member 60 upward, the catheter hub 14 can be easily detached from the lower side of the storage chamber 62a. Further, the catheter assembly 10</b>A may include a guide wire that is inserted into the inner needle 16 and is capable of moving forward and backward with respect to the inner needle 16.

Hereinafter, other embodiments (second to sixth embodiments) of the catheter assembly 10A of the present invention will be described. In the following description, the same configurations or configurations having the same functions as those of the catheter assembly 10A according to the first embodiment are designated by the same reference numerals, and detailed description thereof will be omitted.

[Second Embodiment]
In the catheter assembly 10B according to the second embodiment, as shown in FIGS. 11 to 15B, the valve body 100 (intermediate member: see FIG. 12) is connected to the proximal end portion of the catheter hub 14, and the valve body 100 is connected to the valve body 100. It differs from the catheter assembly 10A according to the first embodiment in that the safety mechanism 140 is connected. Further, the catheter operating member 160 of the catheter assembly 10B is configured so as to correspond to the structure of the safety mechanism 140.

Specifically, as shown in FIG. 12, the valve body 100 is connected to the fitting portion 102 that is inserted into the hollow portion 14 a of the catheter hub 14 and is fitted to the fitting portion 102, and is connected to the proximal end side of the fitting portion 102 in the proximal direction. And a connecting portion 104 that is shortly projected to be connected to the safety mechanism 140. Inside the fitting portion 102 and the connecting portion 104, a valve hole 106 is formed which allows the inner needle 16 to be inserted and which is in close contact with the outer peripheral surface of the inner needle 16.

The fitting portion 102 is formed in a tapered shape that gradually tapers from the axially intermediate portion of the valve body 100 toward the tip end direction. The fitting portion 102 (valve body 100) elastically deforms as it is inserted into the catheter hub 14, and comes into liquid-tight contact with the inner surface of the catheter hub 14.

The material forming the valve body 100 is not particularly limited, but for example, natural rubber, isoprene rubber, butyl rubber, butadiene rubber, styrene-butadiene rubber, urethane rubber, nitrile rubber, acrylic rubber, fluororubber, silicone rubber. And various elastic materials such as urethane-based, polyester-based, polyamide-based, olefin-based and styrene-based thermoplastic elastomers, or a mixture thereof. The valve body 100 may have porosity in order to allow the gas in the hollow portion 14a to escape in the proximal direction.
Further, the valve body 100 may be made of an elastic body and a harder material surrounding the elastic body. As described above, the elastic body and the harder material that surrounds the elastic body can prevent the valve body from deforming with time when the needle penetrates the valve body 100. In addition, the user can easily grip the valve body 100. Further, it becomes easy to control the separation strength between the valve body 100 and the safety mechanism 140.

On the other hand, the connecting portion 104 extends from the boundary of the fitting portion 102 toward the proximal direction by a predetermined length, and the outer peripheral surface thereof is provided with a locking groove 104a. When the connecting portion 104 is inserted into the outer cylinder 150 of the safety mechanism 140 in a puncturable state, the hooks 44a of the pair of arms 44, 44 provided in the safety mechanism 140 are hooked in the locking groove 104a. The locking groove 104a is, for example, recessed in a triangular shape in cross section, and is formed in an annular shape along the circumferential direction of the connecting portion 104.

The safety mechanism 140 is composed of an inner cylinder 141 and an outer cylinder 150, as in the first embodiment. Similar to the first embodiment, the inner cylinder 141 has a box body 42 and an inner cylinder portion 45, and has an insertion hole 46, through which the inner needle 16 is inserted and arranged, at the axial center. A pair of arms 44, 44 that engages and holds the connecting portion 104 of the valve body 100 is provided on both side surfaces of the box body 42 of the inner cylinder 141 in the vertical direction.

A blocking member 142 and a permissible space 45a that allows the blocking member 142 to be displaced in the vertical direction are vertically formed at the front end side of the inner tubular portion 45 of the inner cylinder 141. The allowable space 45a communicates with the insertion hole 46. The blocking member 142 is coupled to the box body 42 via the coupling arm 143, and when the inner needle 16 is positioned in the allowable space 45a in the puncturable state, the blocking member 142 is pushed by the outer surface of the inner needle 16 to allow the allowable space 45a. Is located in the upper position of the. Then, when the inner needle 16 moves toward the base end side of the blocking member 142 due to the retreat of the inner needle 16 with respect to the safety mechanism 140, the blocking member 142 can be displaced below the allowable space 45a. Then, the inner cylinder 141 relatively moves in the distal direction with respect to the outer cylinder 150, the upper inclined surface thereof is guided to the outer cylinder portion 52 of the outer cylinder 150, and the blocking member 142 enters the outer cylinder 150. Get in. Then, at the position where the inner protrusion of the inner tubular portion 45 has moved to the tip of the elongated hole 52 a of the outer barrel 150, the vertical displacement of the blocking member 142 is restricted by the inner surface of the housing 151 of the outer barrel 150, and the insertion hole 46 is inserted. Cut off. As a result, the base end surface of the blocking member 142 faces the inner needle 16 and prevents the inner needle 16 from being re-exposed.

As shown in FIGS. 11 and 13B, the outer cylinder 150 has a cylindrical housing 151 in which both widthwise side surfaces are flat and both vertical direction side surfaces are arcuate, and the first embodiment. And an outer cylindrical portion 52 having a similar long hole 52a. Inside the housing 151, a housing chamber 151 a for housing the box body 42 of the inner cylinder 141 and the pair of arms 44, 44 is provided. The accommodation chamber 151a is formed wide in the vertical direction and communicates with a tip opening 151b provided at the tip of the accommodation body 151.

The outer cylinder portion 52 of the outer cylinder 150 is formed on the outer peripheral surface parallel to the axial direction, and a base end flange portion 55 is provided at the base end thereof. An unillustrated retaining member 152 (see FIG. 13B) is provided at the base end portion of the outer tubular portion 52, and the retaining member 152 has a function of preventing the inner needle 16 from coming off the outer casing 150. (See also the retaining member 246 of the third embodiment).

On the other hand, as shown in FIG. 13A, the catheter operating member 160 has an operating plate portion 61 configured similarly to the first embodiment and a detachment restricting portion 163 connected to the base end of the operating plate portion 61. The release restricting portion 163 is connected to the pair of projecting pieces 164 and 164 that are continuous in the surface direction of the operation plate portion 61, and a pair of extending portions that are connected to the lower sides of the side edges of the projecting pieces 164 and 164 and extend in the proximal direction. 168 and 168, a pair of hub engaging portions 169 and 169 respectively provided on the side surfaces of the pair of extending portions 168 and 168, and a restricting body portion 170 that bridges the base ends of the pair of extending portions 168 and 168. Have.

The pair of extending portions 168 and 168 are set such that the length in the extending direction corresponds to the entire length of the outer cylinder 150 of the safety mechanism 140, and the proximal ends of the pair of extending portions 168 and 168 have the outer cylinder portion 52 at the proximal end. It contacts the base flange portion 55 of. The catheter 12 is held by the holding portion 65 of the operating plate portion 61 in a pierceable state, while the catheter hub 14 is disposed between the pair of extending portions 168, 168 and above the catheter operating member 160. It is exposed below.

The pair of extending portions 168, 168 widens downward from the pair of projecting pieces 164, 164 in the proximal direction, extends from the middle position in the proximal direction with a constant width, and extends in the base of the hub engaging portion 169. It is formed in a plate shape that widens from the end to the upper side. The rigidity of the pair of extending portions 168, 168 is increased by connecting the pair of extending portions 168, 168 with each other by the base body 170 on the proximal end side.

The pair of hub engaging portions 169, 169 are formed so as to project inward in the width direction at an intermediate position of the pair of extending portions 168, 168. The pair of hub engaging portions 169, 169 are formed in a block shape as in the first embodiment, and come into contact with the proximal end of the catheter hub 14 housed in the hub housing portion 62, whereby the advancing operation of the catheter operating member 160 is performed. The catheter hub 14 can be integrally moved at any time.

The regulation main body portion 170 bridges the pair of side connecting portions 171 and 171 projecting inward in the width direction of the pair of extending portions 168 and the pair of side connecting portions 171 and 171 in an arc shape. And a bridge 172. The pair of side connecting parts 171, 171 and the bridging part 172 are formed to have a sufficient thickness along the extending direction of the extending part 168. Further, the pair of side connecting portions 171, 171 and the bridge portion 172 have a substantially circular locking space 173 inside thereof, and a communication gap 172a communicating with this locking space 173 is opened downward. It is formed in a C shape.

On the lower side of the pair of side connecting portions 171, 171 are locking projections 174 that are shorter than the axial length of the pair of side connecting portions 171 but narrower than the outer diameter of the outer tubular portion 52. 174 are provided respectively. When the regulation main body portion 170 is assembled, the outer cylinder portion 52 is inserted into the locking space 173 through the communication gap 172a by pushing the outer cylinder portion 52 with a strong force so as to get over the pair of locking protrusions 174 and 174. To do. The outer tubular portion 52 is relatively easily movable (sliding) relative to the pair of side connecting portions 171, 171 and the bridging portion 172 while being arranged in the locking space 173. Further, the regulation main body 170 functions so that the bridging portion 172 exerts rigidity in a state where the outer tubular portion 52 is covered by the exterior so that the bridging portion 172 does not easily come off the outer tubular portion 52.

The catheter assembly 10B according to the second embodiment is basically configured as described above, and its function and effect will be described below.

The catheter assembly 10B is used in the puncturable state (first state) shown in FIG. 11, and the puncturing operation and the catheter advancing operation are performed as in the first embodiment. In the catheter advancing operation, when the user pushes out the operating plate portion 61 in the distal direction, the holding portion 65 of the operating plate portion 61 holds the catheter 12 and the pair of hub engaging portions 169 of the catheter operating member 160 causes the hub engaging portion 169 to move. Push the proximal end of 14 to advance the catheter hub 14. As a result, the safety mechanism 140 (the inner cylinder 141 and the outer cylinder 150 on which the blocking member 142 of the inner cylinder 141 is hooked) hooks the hook 44a on the valve body 100 of the catheter hub 14 integrally with the catheter hub 14. Moving. The operation plate portion 61 releases the holding of the catheter 12 due to the bending when advanced.

When the catheter 12 is inserted into the patient by the catheter advancing operation, the user performs an inner needle retracting operation of pulling out the inner needle 16 and the housing 20 in the proximal direction. In the inner needle retracting operation, the catheter hub 14 is in the second state in which it is exposed from the tip of the housing 20 as shown in FIG. 14A. At this time, the safety mechanism 140 allows the inner needle 16 to retreat to the base end side with respect to the blocking member 142, thereby allowing the blocking member 142 to move into the allowable space 45a (see FIG. 12). Then, the thickened needle tip 16a of the inner needle 16 is hooked on the retaining member 152 provided on the base end wall 56 of the outer cylinder 150, so that the inner needle 16 is continuously accommodated in the safety mechanism 140. In the safety mechanism 140, the blocking member 142 is pushed by the outer cylinder 150 to close the insertion hole 46, thereby preventing the needle tip 16a from being re-exposed.

The inner cylinder 141 advances in the distal direction with respect to the outer cylinder 150 when the blocking of the outer cylinder 150 by the blocking member 142 is eliminated. As a result, as shown in FIG. 14B, the catheter hub 14, the catheter operating member 160, and the inner cylinder 141 integrally advance relative to the outer cylinder 150, and the box 42 is exposed from the tip of the outer cylinder 150. Then, at the stage where the inner protrusion 49 of the inner cylinder 141 is caught by the housing 151 of the outer cylinder 150 (see also FIG. 12 ), the pair of arms 44, 44 are sufficiently exposed to engage with the valve body 100. To release.

As a result, the catheter 12, the catheter hub 14, and the valve body 100 are freed with respect to the catheter operating member 160, and separated from the scheduled disposal assembly 180 as the indwelling assembly 19 as shown in FIG. 15A ( Detachment operation). That is, the connection strength of the safety mechanism 140 to the catheter hub 14 is a predetermined strength, but in the second state, the connection strength shifts to zero and the catheter hub 14 is automatically detached from the catheter operating member 160.

After that, when connecting the connector of the infusion tube, the user removes the valve body 100 from the catheter hub 14 and leaves the catheter 12 and the catheter hub 14 in the patient, as shown in FIG. 15B. On the other hand, the inner needle 16, the housing 20, the safety mechanism 140, and the catheter operating member 160, which are separated from the catheter 12 and the catheter hub 14, which are the assembly 180 to be discarded, are collectively discarded by the user (discarding operation).

As described above, the catheter assembly 10B according to the second embodiment can also obtain the same effect as the catheter assembly 10A according to the first embodiment. In particular, the catheter assembly 10</b>B is configured such that the valve element 100 is connected to the inside of the catheter hub 14 so that the catheter operating member 160 is not engaged with the catheter hub 14. Accordingly, the disconnection of the valve body 100 and the safety mechanism 140 can further simplify the detachment of the catheter operating member 160 from the catheter hub 14.

Of course, the catheter assembly 10B according to the second embodiment can also take various modifications. For example, the configuration provided between the catheter hub 14 and the safety mechanism 140 is not limited to the valve body 100, and various intermediate members that can connect the catheter hub 14 and the safety mechanism 140 may be adopted. For example, the intermediate member is rigidly made of a resin material similar to that of the catheter hub 14, and is connected to the connection mechanism that engages with the flange of the catheter hub 14 to close the hollow portion 14a and the safety mechanism 140 that is connected to the proximal end of the connection mechanism. It is preferable to have a held mechanism that is held.

[Third Embodiment]
As shown in FIGS. 16 to 20B, the catheter assembly 10C according to the third embodiment is different from the catheter assemblies 10A and 10B according to the first and second embodiments in the configurations of the safety mechanism 240 and the catheter operating member 260. ..

In detail, as shown in FIG. 16, the safety mechanism 240 is configured as a single member by assembling two parts that are individually formed with the widthwise center part as a division base point and fixing them to each other to form the housing 20. It is housed and fixed inside. The safety mechanism 240 has a re-exposure prevention mechanism portion 241, a mounted portion 242, and a retaining portion 243 from the tip end toward the base end direction.

The re-exposure prevention mechanism portion 241 is formed in a rectangular shape having a long vertical width and a short horizontal width, and a cavity 42a for accommodating the shutter 47 is provided therein (see FIG. 17). The cavity 42 a is provided with a placement wall portion 244 that fixes the placement of the shutter 47 by the two components that form the safety mechanism 240.

The mounted portion 242 has a recessed groove 245 that is continuous with the base end of the re-exposure prevention mechanism portion 241 and that is recessed radially inward. The recessed groove 245 is formed to have a width that is approximately the same as the axial thickness of the restricting main body portion 270 of the catheter operating member 260, and the restricting main body portion 270 of the catheter operating member 260 is mounted so as to enter the recessed groove 245. It

The retaining portion 243 has a small space for accommodating the retaining member 246, and fixedly holds the tip of the retaining member 246 formed in a convex shape. The outer diameter of the inner needle 16 near the needle tip 16a is formed to be thicker (wider) than the retaining member 246, and the detachment from the retaining member 246 is restricted.

On the other hand, as shown in FIGS. 18A and 18B, the catheter operating member 260 has an operating plate portion 61, a hub accommodating portion 62, and a separation restricting portion 263. Inside the hub accommodating portion 62, arcuate protrusions 262 that project inward from the pair of side plates 66, 66 and the upper plate 67 are provided, and the arcuate protrusions 262 are annular shapes formed on the outer peripheral surface of the catheter hub 14. It is inserted into the groove 214. The arcuate projection 262 is only inserted without being fitted into the annular groove 214, and the catheter operating member 260 does not have a holding force that restricts downward movement of the catheter hub 14 with respect to the catheter operating member 260. Therefore, the catheter hub 14 is connected to the safety mechanism 240 and the catheter operating member 260 with zero connection strength.

As shown in FIGS. 18A and 18B, the separation restricting portion 263 is connected to the upper side surfaces of the pair of side plates 66, 66 and extends a predetermined length in the proximal direction, and a pair of extending portions 268, 268. The restriction main body 270 bridging the base ends of the existing portions 268, 268. The pair of extending portions 268, 268 is formed in the shape of an elongated flat plate at the same height as the operation plate portion 61, and is arranged along the upper surfaces of the side walls 22, 23 of the housing 20 in a puncturable state. Therefore, the pair of extending portions 268, 268 can move within the rail portion 29 of the housing 20.

The regulation main body portion 270 has a C shape having a locking space 73 and a communication gap 72a, and is formed in a plate shape having a predetermined thickness in the axial direction. The regulation main body portion 270 is configured to enter the concave groove 245 of the safety mechanism 240 and fit into the bottom portion of the concave groove 245 (the tubular portion of the safety mechanism 240).

The catheter assembly 10C according to the third embodiment is basically configured as described above, and its function and effect will be described below.

The catheter assembly 10C is used in the puncturable state shown in FIG. 16, and the puncturing operation and the catheter advancing operation are performed as in the first and second embodiments. In the catheter advancing operation, when the user pushes out the operation plate portion 61 in the distal direction, the arcuate projection 262 of the hub housing portion 62 advances the catheter hub 14, and the regulation body portion 270 advances the safety mechanism 240. The operation plate portion 61 bends at the time of advancing to release the holding of the catheter 12.

When the catheter 12 is inserted into the patient by the catheter advancing operation, the user performs an inner needle retracting operation of pulling out the inner needle 16 and the housing 20 in the proximal direction. In the inner needle retracting operation, the safety mechanism 240 automatically closes the cavity 42a by the shutter 47 by retracting the inner needle 16 toward the base end side of the shutter 47. Then, the thickened needle tip 16a of the inner needle 16 is caught by the retaining member 246 provided in the safety mechanism 240, so that the inner needle 16 is continuously accommodated in the safety mechanism 240.

The catheter operating member 260 is exposed from the tip of the housing 20 so that the catheter hub 14 can be detached from the hub housing portion 62. Particularly, in the catheter assembly 10C, the indwelling assembly 19 has a connection strength of zero with respect to the catheter operating member 260 and the safety mechanism 240, and when the inner needle 16 is pulled out in the catheter hub 14, the catheter operating member 260 is removed. Will automatically leave. This allows the user to easily place the catheter 12 and catheter hub 14 indwelling assembly 19 on the patient, as shown in FIG. 19B. On the other hand, the user can collectively discard the inner needle 16, the housing 20, the safety mechanism 240, and the catheter operating member 260, which is the assembly 280 (second assembly) to be discarded (discarding operation).

As described above, the catheter assembly 10C according to the third embodiment can also obtain the same effects as the catheter assemblies 10A and 10B according to the first and second embodiments. Further, in this catheter assembly 10C, since the mutual connection strength between the catheter hub 14 and the safety mechanism 240 is zero, the catheter operating member 260 and the catheter hub 14 can be separated more easily. .. As a result, the detaching operation of the catheter hub 14 and the catheter operating member 260 can be omitted, and the user can operate the catheter assembly 10C more easily. Further, in this case, it is possible to suppress the positional displacement of the catheter 12 and the contamination of the catheter hub 14, which may occur during the detaching operation.

The catheter operating member 260 of the catheter assembly 10C holds the catheter hub 14 with an appropriate connection strength when the catheter hub 14 is accommodated in the hub accommodating portion 62, and the catheter hub 14 is positioned below the hub accommodating portion 62. It may be configured so that it does not come off easily. In this case, in order to facilitate the operation of detaching the catheter hub 14 from the catheter operating member 260, it is preferable to provide a tab 215 on the upper surface exposed from the catheter operating member 260 of the catheter hub 14 as shown in FIG. 20A. The user can easily remove the catheter hub 14 from the hub housing 62 by pushing the tab 215 downward.

Further, as shown in FIG. 20B, a pair of operation wings 216, 216 projecting outward in the width direction are provided on the outer peripheral surface of the catheter hub 14, and each operation wing 216, 216 forms a pair of side plates 66 of the catheter operation member 260. It may be configured so as to project outside of 66. The user can easily detach the catheter hub 14 from the hub accommodating portion 62 by pushing the pair of operation wings 216, 216 downward. Further, the pair of operation wings 216, 216 can also function as an attachment portion that can be easily attached to the body surface of the patient when the catheter hub 14 is in the indwelling state. Note that the operation wing 216 is not particularly limited in its shape as long as it projects to the outside of the hub housing portion 62, and for example, only one operation wing may be provided on the outer peripheral surface.

[Fourth Embodiment]
As shown in FIGS. 21 to 22C, the catheter assembly 10D according to the fourth embodiment has a structure in which the inner needle 16 is automatically moved backward into the housing 320 as the safety mechanism 340 advances as the catheter hub 14 advances. This is different from the catheter assemblies 10A to 10C according to the first to third embodiments.

The structure of the catheter assembly 10D is not particularly limited, but, for example, the needle holding member 325 holding the inner needle 16 is made to be an elastic member when the catheter hub 14 reaches a predetermined advance amount with respect to the housing 320. It is advisable to employ a structure in which the coil spring 326 or the like moves the element in the proximal direction. Specifically, the housing 320 is formed into a bottomed rectangular tube shape with an open front end, and has a relay tube 327 to which the catheter operating member 360 is connected, and a tubular tube housed in the relay tube 327. It has a needle holding member 325 and a coil spring 326 that biases the needle holding member 325 in the proximal direction. Further, the needle holding member 325 is engaged with the housing 320 by the lock member 328 in a puncturable state, and its movement in the proximal direction is restricted.

The relay tube 327 has a head portion 327a that is inserted into the catheter hub 14 and holds the catheter hub 14, and a proximal end tubular portion 327b that extends from the head portion 327a in the proximal direction by a predetermined length. A connecting groove 327c is provided on the outer peripheral surface of the head 327a. The separation restricting portion 363 of the catheter operating member 360 is fitted into the connecting groove 327c of the relay cylinder 327 (safety mechanism 340) to restrict separation, and the catheter 12, the catheter hub 14, and the relay cylinder 327 are integrally formed. Advance. The catheter operating member 360 may have the holding portion 65, the hub housing portion 62, and the like. A lock member 328 is arranged at an intermediate position on the outer peripheral surface of the proximal end cylinder portion 327b.

On the other hand, the needle holding member 325 is inserted into the relay cylinder 327 and holds the inner needle 16 at the tip end thereof, and an inner holding portion 329 that projects radially outward from the base end of the inner holding portion 329 and that of the inner holding portion 329. And an outer receiving cylinder 330 that extends outward in the front end direction. A through-hole portion 330 a through which the lock member 328 is arranged is provided at a predetermined position of the outer receiving cylinder 330. Further, the tip end surface of the outer receiving cylinder 330 is configured as a seat for receiving the coil spring 326.

The lock member 328 is formed in a triangular shape in a side cross-sectional view, and while being arranged on the outer peripheral surface of the relay cylinder 327, penetrates the through-hole portion 330 a of the needle holding member 325, and a part of the lock member 328 is formed on the housing 320. It is inserted into a lock hole 320a provided on the inner surface of the. Accordingly, the lock member 328 restricts the movement of the needle holding member 325 in the proximal direction, and allows the relay cylinder 327 to slide relatively.

The catheter assembly 10D according to the fourth embodiment is basically configured as described above, and its function and effect will be described below.

The catheter assembly 10D is used in the puncturable state shown in FIGS. 21 and 22A, and the puncturing operation and the catheter advancing operation are performed as in the first embodiment. In the catheter advancing operation, the user pushes the catheter operating member 360 in the distal direction relative to the housing 320. As a result, the relay cylinder 327 to which the detachment restricting portion 363 of the catheter operating member 360 is connected is integrally advanced, and the catheter 12 and the catheter hub 14 are also advanced. On the other hand, the needle holding member 325 continues to be in a state where the movement thereof is restricted by the lock member 328.

When the catheter 12 is inserted into the patient by the catheter advancing operation, the user performs an inner needle retracting operation of pulling out the inner needle 16 and the housing 320 in the proximal direction. In the inner needle retreating operation, the relay cylinder 327 relatively moves toward the distal end side as the housing 320 and the needle holding member 325 retreat in the proximal direction. Then, as shown in FIG. 22B, when the lock member 328 moves to the proximal end portion of the relay cylinder 327, the lock member 328 comes out from the lock hole portion 320 a of the housing 320, and the relative movement of the needle holding member 325 with respect to the housing 320. It is possible. Since the needle holding member 325 is biased in the proximal direction by the coil spring 326, when the lock member 328 is unlocked, the coil spring 326 elastically extends and retracts in the proximal direction. As a result, the inner needle 16 is automatically retracted and accommodated in the housing 320, thereby preventing the needle tip 16a from being re-exposed.

On the other hand, the relay tube 327 is prevented from coming off from the housing 320 by being caught by the coming-off preventing projection 320b in the housing 320 when the catheter hub 14 has advanced a predetermined distance. Further, since the catheter operating member 360 is connected to the relay cylinder 327, it is prevented from being separated from the relay cylinder 327. Therefore, the to-be-discarded assembly 380 (the inner needle 16, the housing 320, the needle holding member 325, the relay cylinder 327) is integrally connected, and only the catheter 12 and the catheter hub 14 which are the indwelling assembly 19 are to be disposed of. It is separated from the solid 380 and placed. The to-be-discarded assembly 380 is collectively disposed of by the user.

As described above, the catheter assembly 10D according to the fourth embodiment can also obtain the same effects as the catheter assemblies 10A to 10C according to the first to third embodiments. In particular, the catheter assembly 10D can easily prevent re-exposure of the inner needle 16 by retracting the inner needle 16 relative to the housing 320 and storing the inner needle 16 in the housing 320. The safety at the time of handling (disposing) can be further enhanced.

[Fifth Embodiment]
The catheter assembly 10E according to the fifth embodiment is the catheter assembly according to the first to fourth embodiments in that the catheter operating member 460 is prevented from coming off by being locked to the housing 420 as the catheter operating member 460 advances. Different from 10A-10D. Further, this catheter assembly 10E is discarded with the inner needle 16 exposed when the inner needle 16 is retracted. That is, the catheter assembly according to the present invention may not have the safety mechanism 40, 140, 240, 340 as shown in the first to fourth embodiments.

In detail, the catheter assembly 10E is a housing having a catheter operating member 460 extending in the proximal direction from the housing 420 and a locking mechanism 421 for locking the catheter operating member 460 in a puncturable state. And 420.

The catheter operating member 460 includes an operating plate portion 61, a hub accommodating portion 462, and a separation restricting portion 463 that is flush with the upper plate 467 of the hub accommodating portion 462 and extends a predetermined length in the proximal direction. The hub storage portion 462 has a storage chamber 462a for storing the distal end portion of the catheter hub 14, and an opening 462b on the proximal end side of the storage chamber 462a, so that the flange 15 of the catheter hub 14 is exposed. There is. The upper plate 467 of the hub accommodating portion 462 has a dome portion 468 that rises in an arc shape in accordance with the shape of the catheter hub 14, and a pair of continuous dome portions 468 on both sides of the dome portion 468 and flush with the operation plate portion 61. It has upper plate side pieces 469, 469. The pair of upper plate side pieces 469, 469 is formed in a size that can be inserted into the pair of rail portions 29 of the housing 420, and is placed on the upper surfaces of the side walls 22, 23 of the housing 420 in a puncturable state. Further, among the pair of upper plate side pieces 469, 469, the upper plate side piece 469 on the side where the support member 30 is installed is provided with a notch portion 469a which is cut out inward in the width direction together with the side edge of the operation plate portion 61. ing. A tip end side of the upper plate side piece 469 connected to the cutout portion 469a has a tapered edge portion 469b which is widened in a taper shape toward the base end direction.

The separation restricting portion 463 is connected to the pair of upper plate side pieces 469 of the upper plate 467 and extends in the proximal direction, and the restricting main body portion 470 provided at the proximal end of the extending portion 464. Have and. The extending portion 464 is formed to have a horizontal width that is the same as the horizontal width of the operation plate portion 61, a thickness that allows the rail portion 29 of the housing 420 to pass therethrough, and extends in a planar shape in the proximal direction. The tip of the extending portion 464 constitutes the base edge of the opening 462b.

The regulation main body portion 470 is configured as a ridge portion 471 that projects to the upper surface at the base end of the extending portion 464 and extends in the width direction. As shown in FIG. 24, the protruding portion 471 has a tip end surface 471 a that is orthogonal to the surface direction of the extending portion 464, and protrudes outward in the width direction from one side edge of the extending portion 464. 472. The protrusion 472 is formed in a right-angled triangle having an acute angle at the tip and the lower side in a side view, and is set to have a protrusion amount that matches the outer surface of the side wall 22 of the housing 420.

On the other hand, the locking mechanism 421 of the housing 420 is provided above the pair of side walls 22 and 23 and on the base end side of the rail portion 29. The locking mechanism 421 has a pair of side walls 22 and 23 forming the upper side of the rail portion 29, and an abutting surface 422 that abuts the tip end surface 471 a of the protruding portion 471 of the catheter operating member 460. The contact surface 422 is formed on a surface orthogonal to the axial direction of the housing 420, and is capable of surface contact with the tip surface 471a.

Further, the locking mechanism 421 has a retreat restriction protrusion 423 on the upper surface of the side wall 22 on which the support member 30 is provided, at a position slightly away from the formation position of the contact surface 422 toward the base end side. The retreat restricting protrusions 423 only slightly protrude from the upper surface of the side wall 22, and each side edge of the operation plate portion 61, the upper plate side piece 469 of the hub accommodating portion 462, and the extending portion 464 of the separation restricting portion 463. Is provided on the outer surface side of the side wall 22 so as to be able to pass through inside, and is narrowed. The tip end side of the retreat restricting projection 423 is formed on a locking end surface 424 orthogonal to the axial direction of the housing 420. Further, the retreat restricting protrusion 423 has an inclined surface 425 that inclines downward from the upper end of the locking end surface 424 toward the base end direction.

The catheter assembly 10E according to the fifth embodiment is basically configured as described above, and its function and effect will be described below.

The catheter assembly 10E is used in the puncturable state shown in FIG. 23, and the puncturing operation and the catheter advancing operation are performed as in the first to fourth embodiments. In the catheter advancing operation, when the user pushes out the operation plate portion 61 in the distal direction, the arcuate projection 262 of the extending portion 464 of the catheter operating member 460 advances the annular groove 214 of the catheter hub 14 (see also FIG. 25A). .. In addition, the operation plate portion 61 is curved when it advances, so that the holding of the catheter 12 by the holding portion 65 is released.

In this catheter advancing operation, as shown in FIGS. 25A and 25B, the side edge of the operation plate portion 61 of the catheter operation member 460 passes through the rail portion 29 of the housing 420 and the upper portion of the shaft rod portion 31 of the support member 30. It moves through a guide recess 33 a provided in the protrusion 33. Therefore, the support member 30 is restricted from rotating and supports the catheter 12 under the support.

Then, in the catheter operating member 460, as shown in FIG. 25C, when the side edge of the operation plate portion 61 has passed and reached the cutout portion 469a, the side plate 66 of the hub housing portion 462 contacts the support body 32. The support member 30 is rotated. At this time, since the notch 469a is located in the guide recess 33a, the rotation of the upper protrusion 33 is allowed, and the support body 32 can be easily rotated about the shaft rod portion 31. As a result, as shown in FIG. 25C, the support member 30 (upper protrusion 33) rotates 90° during this rotation.

Further, the catheter operating member 460 passes the side edge of the extending portion 464 from the cutout portion 469a. As described above, the extending portion 464 is formed with the tapered edge portion 469b on the front end side, and the upper protrusion 33 of the support member 30 is brought into contact with the tapered edge portion 469b, so that the extending portion 464 is rotated by 90°. Further rotation is performed (see FIG. 25D). As a result, the support member 30 rotates 180°, exposing the support member 30 to the outside of the side wall 22 of the housing 420, as shown in FIG. As a result, the extending portion 464 of the catheter operating member 460 is guided by the rail portion 29 while smoothly passing through the installation location of the support member 30.

When the catheter 12 is inserted into the patient by the catheter advancing operation, the user performs an inner needle retracting operation of pulling out the inner needle 16 and the housing 420 in the proximal direction. In the inner needle retracting operation, the extension restricting portion 463 of the catheter operating member 460 causes the extending portion 464 to relatively advance with respect to the housing 420, and as shown in FIG. 26A, the catheter hub 14 is removed from the housing 420. Can be exposed. Upon exposure, the catheter hub 14 is in the second state in which the catheter hub 14 can be detached from the hub housing portion 462. At this time, in the catheter operating member 460, the arcuate projection 262 engages with the annular groove 214 of the catheter hub 14 to hold the catheter hub 14 with a weak holding force. Therefore, the user simply performs the detaching operation and detaches the indwelling assembly 19 (the catheter 12 and the catheter hub 14) from the catheter operating member 460 at an appropriate timing to indwell the patient, as shown in FIG. 26B.

Returning to FIG. 24, the protruding portion 472 of the regulation main body portion 470 rides over the inclined surface 425 of the receding regulation projection 423 formed on the upper surface of the side wall 22 of the housing 420 in the inner needle retracting operation. As a result, the tip end surface 471a of the ridge portion 471 of the regulation body portion 470 comes into contact with the contact surface 422, and the catheter operating member 460 is prevented from being detached from the housing 420. Further, the base end surface of the projecting portion 472 that has passed over the retreat restricting projection 423 faces the locking end surface 424. Therefore, the backward movement of the catheter operating member 460 with respect to the housing 420 is restricted, and the catheter operating member 460 and the housing 420 are properly locked. Therefore, the user can collectively discard the inner needle 16, the housing 420, and the catheter operating member 460, which are the scheduled assembly 480 (discarding operation).

As described above, the catheter assembly 10E according to the fifth embodiment can also obtain the same operational effects as the catheter assemblies 10A to 10D according to the first to fourth embodiments. Further, in the catheter assembly 10E, the separation restricting portion 463 of the catheter operating member 460 has the extending part 464 and the restricting main body part 470, and restricts the movement of the catheter operating member 460 at a predetermined position of the housing 420 and disengages. Can be prevented. Further, the restricting body 470 is easily and surely locked to the locking mechanism 421 of the housing 420, so that the catheter operating member 460 can be surely restricted from being separated.

It should be noted that the catheter assembly 10E in which the housing 420 and the catheter operating member 460 are locked to restrict the separation can also adopt various configurations. For example, in the catheter assembly 10E, the extension restricting portion 463 can be extended. The existing portion 464 may be flexibly configured and accommodated in the housing 420. The flexible extending portion 464 can keep the catheter operating member 460 and the housing 420 from being separated by continuing to be connected to the housing 420 even when the catheter operating member 460 advances. Moreover, since the flexible extension part 464 can shorten the total length of the catheter assembly 10E, the operation by the user can be made easier.

Alternatively, for example, as shown in FIG. 27A, the inner needle 16 may be retracted in the proximal direction of the housing 420 to be housed. In this case, the catheter assembly 10E is punctured by the user in the puncturable state shown in the figure. After that, when the catheter advancing operation and the inner needle retracting operation are performed, the catheter operating member 460 is hooked on the housing 420 as shown in FIG. 27B.

Then, in this state, when the user presses a button (not shown) provided on the housing 420, as shown in FIG. 27C, the inner needle 16 (needle holding) is moved toward the proximal end of the housing 420 based on the urging force of the elastic member 482. The member 325) is moved to be housed in the housing 420. In the catheter assembly 10</b>E, the inner needle 16 is pulled out from the catheter hub 14 due to the retraction of the inner needle 16, and the catheter 12 and the catheter hub 14 are detached from the scheduled disposal assembly 480. It should be noted that the mechanism for moving the inner needle 16 backward may be configured to automatically move backward by using the catheter operation member 460 having advanced a predetermined amount as a trigger, similarly to the fourth embodiment, regardless of the button operation. Good.

[Sixth Embodiment]
As shown in FIGS. 28 to 30, the catheter assembly 10F according to the sixth embodiment has the same configuration as the catheter assembly 10E according to the fifth embodiment, but the catheter operating member 560 has a retaining ring 561. It differs from the catheter assembly 10E in that a (penetration holding portion) is provided.

In detail, the separation restricting portion 563 of the catheter operating member 560 includes an extending portion 464 that is continuous with the base end of the hub housing portion 462, and a restricting main body portion 470 that is provided at the base end of the extending portion 464. The retaining ring 561 is provided on the lower surface of the existing portion 464. The retaining ring 561 projects downward near the tip of the extending portion 464 and has a substantially semicircular shape in a front view (see also FIG. 30). Further, as shown in FIGS. 29A and 30, the retaining ring 561 extends over a predetermined range in the longitudinal direction of the extending portion 464 in the rear portion of the catheter hub 14. Inside the holding ring 561, a holding hole 561a is formed so as to pass through and hold the inner needle 16 along the axial direction of the holding ring 561.

In the catheter assembly 10F having the above configuration, the inner needle 16 is inserted into the catheter hub 14 and the retaining ring 561 in a puncturable state, so that the inner needle 16 is extended and the catheter operating member 560 is extended. Good condition is maintained. As a result, the displacement of the catheter hub 14 and the catheter operating member 560 is prevented.

On the other hand, also during the catheter advancing operation and the inner needle retracting operation, the inner needle 16 is held by the retaining ring 561 of the catheter operating member 560, so that mutual bending of the inner needle 16 and the catheter operating member 560 is suppressed. .. Further, even after the inner needle 16 is pulled out from the catheter hub 14, by holding the inner needle 16 by the holding ring 561 of the catheter operating member 560, it is possible to prevent the inner needle 16 from immediately becoming a free state.

Further, when the catheter operating member 560 advances toward the housing 420 in the inner needle retracting operation, the restricting main body portion 470 of the disengagement restricting portion 563 is locked by the locking mechanism 421 of the housing 420 to prevent disengagement. Therefore, the inner needle 16, the housing 420, and the catheter operating member 560 can be collectively discarded as the scheduled disposal assembly 580.

As described above, the catheter assembly 10F according to the sixth embodiment can also obtain the same effects as the catheter assemblies 10A to 10F according to the first to fifth embodiments. Further, in the catheter assembly 10F, since the extending portion 464 has the retaining ring 561, it is possible to suppress the bending of the inner needle 16 and the catheter operating member 560 when the catheter operating member 560 advances. Further, the retaining ring 561 can prevent the catheter operating member 560 from coming off the catheter hub 14 before the inner needle 16 is pulled out from the catheter hub 14. Therefore, the advancing operation of the catheter operating member 560 can be favorably performed.

Further, this catheter assembly 10F can also adopt various modified examples. For example, even in the catheter assembly 10F having the retaining ring 561, the proximal end inside the housing 420 shown in FIGS. 27A to 27C. A configuration may be adopted in which the inner needle 16 is retracted in the direction.

Further, for example, in the catheter assembly 10F, the retaining ring 561 can function as the safety mechanism 340. In this case, the retaining ring 561 is inserted into the retaining hole 561a of the retaining ring 561 at the position where the restriction body 470 of the catheter operating member 560 is retained by the retaining mechanism 421 of the housing 420 (see also FIG. 26A). It is provided at a position for accommodating the needle tip 16a. As described above, since the housing 420 and the catheter operating member 560 are restricted from coming off the catheter operating member 560 from the housing 420 in the distal direction and returning to the proximal direction, the inner needle is inserted into the holding hole 561 a of the holding ring 561. 16 can be accommodated continuously, and re-exposure of the needle tip 16a can be prevented.

Further, as shown in FIG. 30, the catheter assembly 10F may have a configuration in which the valve 581 is housed inside the catheter hub 14. In this case, the axis of the holding hole 561a of the holding ring 561 and the axis of the valve hole 581a at the center of the valve 581 are configured to coincide with each other. Thereby, the inner needle 16 inserted into the holding hole 561a and the valve hole 581a can be linearly extended, and the deviation between the inner needle 16 and the catheter hub 14 can be prevented more reliably.

Needless to say, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention.

10A to 10F... Catheter assembly 12... Catheter 14... Catheter hub 16... Inner needle 19... Indwelling assembly 20, 320, 420... Housing 29... Rail part 30... Support members 40, 140, 240, 340... Safety mechanism 41, 141... Inner cylinder 50, 150... Outer cylinder 60, 160, 260, 360, 460, 560... Catheter operating member 62... Hub accommodating portion 63, 163, 263, 363, 463, 563... Disengagement restricting portion 68, 168, 268 464... Extending portions 69, 169... Hub engaging portions 70, 170, 270, 470... Restricting body portions 80, 180, 280, 380, 480, 580... Scheduled disposal assembly 100... Valve body 421... Locking mechanism 422... abutting surface 561... retaining ring

Claims (16)

A hollow catheter,
A catheter hub that holds the catheter fixed,
An inner needle that has a needle tip and is removably inserted into the inside of the catheter;
A needle hub for fixedly holding the inner needle,
A catheter operating member capable of operating the relative movement of the catheter with respect to the inner needle,
The catheter operating member is configured to restrict the movement of more than a predetermined distance relative to the inner needle, it has a detachment restricting portion for restricting the disengagement from the needle hub,
The catheter operating member, that along the axial direction of the catheter extends to be in contact with the catheter, the catheter assembly, characterized in that to suppress the deflection of the catheter and the inner needle when the puncture. A catheter assembly of claim 1 Symbol placement,
The catheter assembly is
A first assembly including the catheter and the catheter hub;
A catheter assembly, wherein the inner needle, the needle hub, and the catheter operating member are separable into a second assembly that connects the inner needle, the needle hub, and the catheter operating member while restricting mutual separation. The catheter assembly according to claim 2 , wherein
The catheter hub is movable to a first state in which it is housed inside the needle hub and a second state in which it is exposed to the outside of the needle hub, by operating the catheter operating member,
In the second state, the catheter operating member is separable from the catheter hub. The catheter assembly according to claim 3 ,
In the first state, the catheter operating member accommodates the needle hub and the needle hub in the needle hub in an inseparable manner within the needle hub. The catheter assembly according to claim 3 or 4 ,
The catheter assembly includes an engaging portion that contacts the catheter hub and pushes out the catheter hub when the catheter operating member advances. A catheter assembly according to any one of claims 3-5,
The catheter assembly has no holding force that restricts downward movement of the catheter hub with respect to the catheter operation member. The catheter assembly according to any one of claims 3 to 7 ,
The second assembly has a safety mechanism connected to the needle hub and non-reexposing the inner needle detached from the catheter,
The catheter assembly, wherein the separation restricting portion connects the catheter operating member to the safety mechanism in a state in which separation is restricted. The catheter assembly according to claim 7 , wherein
A catheter assembly, wherein mutual connection strength between the catheter hub and the safety mechanism is smaller in the second state than in the first state. The catheter assembly according to claim 7 or 8 ,
At least in the second state, the strength of mutual connection between the catheter hub and the safety mechanism becomes zero. The catheter assembly according to any one of claims 7 to 10 ,
The separation restricting portion is provided on an extending portion extending in a proximal direction from a hub disposing portion for disposing the catheter hub, and is provided at a proximal end of the extending portion and is movably engaged with the safety mechanism. A catheter body, comprising: a regulation body. The catheter assembly of claim 10 , wherein
The first assembly has an intermediate member connected to the proximal end of the catheter hub,
The catheter assembly, wherein the safety mechanism is connected to the intermediate member in the first state and disconnects from the intermediate member in the second state. The catheter assembly of claim 11 , wherein
The first assembly has a valve body that is inserted into the proximal end of the catheter hub and projects toward the proximal end.
The safety mechanism is connected to the valve body in the first state, and disconnects the valve body in the second state. The catheter assembly according to any one of claims 3 to 12 ,
The catheter assembly, wherein the separation restricting portion connects the catheter operating member to the needle hub in a state in which separation is restricted. The catheter assembly of claim 13 , wherein
The separation restricting portion is provided with an extending portion that extends in a proximal direction from a hub disposing portion that disposes the catheter hub, and a restricting body portion that is provided at a proximal end of the extending portion and that is locked to the needle hub. And a catheter assembly comprising: The catheter assembly of claim 14 , wherein
The catheter assembly, wherein the extending portion has a penetrating holding portion through which the inner needle is arranged so as to penetrate through the proximal end side of the catheter hub. The catheter assembly according to any one of claims 3 to 15 ,
The second assembly is capable of accommodating the inner needle in the needle hub by retracting the inner needle relative to the needle hub at the time of transition to the second state. ..

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