WO2019188741A1

WO2019188741A1 - Catheter assembly

Info

Publication number: WO2019188741A1
Application number: PCT/JP2019/011965
Authority: WO
Inventors: 立石匡; 石田昌弘
Original assignee: テルモ株式会社
Priority date: 2018-03-28
Filing date: 2019-03-22
Publication date: 2019-10-03
Also published as: JP7183252B2; JPWO2019188741A1

Abstract

A catheter assembly (10A) comprises a catheter (12), a catheter hub (20) that fixedly holds the catheter (12), an inner needle (14) that is detachably inserted into the catheter (12), and an inner needle hub (30) that fixedly holds the inner needle (14) and has a distal end section (31). A support member (40) is arranged in the distal end section (31) of the inner needle hub (30) to enable the catheter (12) to slide while suppressing bending of the catheter (12). The support member (40) detaches from the inner needle hub (30) integrally with movement of the catheter hub (20).

Description

Catheter assembly

The present invention relates to a catheter assembly having a function of suppressing the deflection of the catheter.

JP 2013-529111 discloses a catheter assembly having a double-structured needle in which an inner needle is inserted into a catheter. In this catheter assembly, in order to insert the catheter deeply into the patient's body, the catheter and the inner needle are formed long. The user of the catheter assembly advances the catheter relative to the inner needle while the double-structure needle is punctured, enters the catheter into the blood vessel, and then removes the inner needle from the catheter, thereby moving the catheter to the patient side. In place.

By the way, the catheter assembly disclosed in JP 2013-529111 A separates the catheter and catheter hub from the inner needle and the needle hub by separating the tip side of the inner needle hub vertically when the catheter advances. It has a configuration. However, with such a configuration, the double-structured needle extends in an unsupported (free) state with respect to the separated inner needle hub when the catheter advances. Therefore, the double-structure needle is easily bent by receiving a reaction force from the patient. In some cases, the needle tip may come out of the patient's insertion section due to bending, and the needle tip may puncture the patient again.

The present invention has been made in view of the above circumstances, and an object thereof is to provide a catheter assembly capable of suppressing the deflection of the inner needle during the movement of the catheter.

To achieve the above object, the present invention provides a catheter, a catheter hub for fixing and holding the catheter, an inner needle removably inserted into the catheter, the inner needle fixedly held, and a distal end. A catheter assembly comprising an inner needle hub having a portion, and a support member that suppresses the deflection of the inner needle while allowing the catheter to slide is disposed at the distal end portion of the inner needle hub, The support member is separated from the inner needle hub as the catheter hub moves.

Further, it is preferable that the catheter hub and the support member have an engagement mechanism for engaging the catheter hub and the support member when the catheter hub moves to the distal end portion.

In addition to the above configuration, the support member is configured to be integrated by accommodating a part of the catheter hub from the proximal end to the inside, and the engagement mechanism includes the outer peripheral surface of the catheter hub and the support member. It is good in the structure which fits an inner peripheral surface.

Alternatively, the support member is configured to be integrated by accommodating a part of the catheter hub from the proximal end to the inside, and the engagement mechanism includes an outer peripheral surface of the catheter hub and an inner peripheral surface of the support member. The structure which inserts the convex part provided in the other with respect to the concave part provided in one may be sufficient.

In this case, the engagement mechanism may be capable of engaging the catheter hub at a plurality of positions in the axial direction of the support member.

Further, it is preferable that the support member has a notch extending a predetermined length in the axial direction from the base end.

Further, a catheter operation member that operates movement of the catheter and the catheter hub may be provided.

Still further, the support member may have a portion that detachably engages with the inner needle hub.

The portion that detachably engages with the inner needle hub may include a pair of wings.

Alternatively, the portion that removably engages with the inner needle hub includes a hook portion that is hooked on the inner needle hub in an initial state before puncturing the inner needle, and the hook portion moves the catheter hub. It is also possible to adopt a configuration in which the hook with the inner needle hub is released in conjunction with the movement.

Furthermore, the inner needle hub has a slot extending from a predetermined position in the axial direction of the inner needle hub to the tip, and the slot is inserted into a part of the support member, It should be possible to guide the movement.

In order to achieve the above object, the present invention includes a catheter, a catheter hub for fixing and holding the catheter, an inner needle removably inserted into the catheter, and fixing and holding the inner needle. And an inner needle hub having a distal end portion, a portion disposed at the distal end portion of the inner needle hub and detachably engaged with the inner needle hub, wherein the catheter is slidable while being slidable. And a support member that suppresses bending.

According to the present invention, the catheter assembly has a configuration in which the support member disposed at the distal end portion of the inner needle hub is integrally detached with the movement of the catheter hub, thereby greatly improving the handleability of the catheter assembly. be able to. That is, the support member can suppress bending of the inner needle inserted into the catheter while contacting the outer peripheral surface of the catheter when the catheter and the inner needle are punctured into the living body or when the catheter is inserted into the blood vessel. .

It is a perspective view showing the whole catheter assembly composition concerning a 1st embodiment of the present invention. FIG. 2A is a plan view showing the support member. FIG. 2B is a side view of the support member. FIG. 3A is a plan view showing a state where the catheter hub is engaged with the support member. FIG. 3B is a front view showing a state where the catheter hub is engaged with the support member. FIG. 4A is a side view showing the distal end portion of the inner needle hub in a state where the support member is arranged. FIG. 4B is a side view showing a state where the catheter hub and the support member are detached from the inner needle hub. FIG. 5A is a first explanatory view showing the operation of the catheter assembly of FIG. 1. FIG. 5B is a second explanatory view showing the operation of the catheter assembly of FIG. 1. FIG. 5C is a third explanatory view showing the operation of the catheter assembly of FIG. 1. FIG. 6A is a fourth explanatory view showing the operation of the catheter assembly of FIG. 1. FIG. 6B is a fifth explanatory view showing the operation of the catheter assembly of FIG. 1. FIG. 7A is a side view showing a catheter assembly according to a second embodiment. FIG. 7B is a front view showing an engaged state of the catheter hub and the catheter operation member. FIG. 7C is a side view showing an engaged state of the catheter hub and the catheter operation member. FIG. 8A is a first explanatory view showing the operation of the catheter assembly of FIG. 7A. FIG. 8B is a second explanatory view showing the operation of the catheter assembly of FIG. 7A. FIG. 8C is a third explanatory view showing the operation of the catheter assembly of FIG. 7A. FIG. 9A is a plan view showing a support member of the catheter assembly according to the third embodiment. FIG. 9B is a side view of the support member of FIG. 9A. 9C is a cross-sectional plan view of the support member of FIG. 9A. FIG. 10A is a plan view showing the catheter hub of the catheter assembly. FIG. 10B is a side view for explaining the engaged state of the catheter hub and the support member. It is a perspective view which shows the catheter hub and support member of the catheter assembly which concern on 4th Embodiment. 12A is a schematic side view of a catheter assembly having the catheter hub and support member of FIG. 12B is a schematic plan view of the catheter assembly of FIG. 12A. FIG. 13A is a schematic side view showing the movement operation of the catheter hub of the catheter assembly of FIG. 12A. FIG. 13B is a schematic plan view of the catheter assembly of FIG. 13A. FIG. 14A is a schematic side view showing the movement operation of the catheter hub following FIG. 13A. 14B is a schematic plan view of the catheter assembly of FIG. 14A.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

[First Embodiment]
As shown in FIG. 1, the catheter assembly 10A according to the first embodiment has a catheter 12 that is inserted into the body from outside the patient's body, and the catheter 12 constructs an infusion part for blood transfusion or blood transfusion in the patient (living body). To do. The catheter 12 is longer than the peripheral venous catheter (for example, applied to a central venous catheter, PICC, midline catheter, etc.). The catheter 12 may be configured as a peripheral venous catheter, or may be configured not only for a venous catheter but also for an artery such as a peripheral artery catheter.

The catheter assembly 10A includes an inner needle 14 inserted into the catheter 12, a catheter hub 20 for fixing and holding the catheter 12, and an inner needle hub 30 for fixing and holding the inner needle 14, in addition to the catheter 12. The catheter assembly 10A constitutes a double-structure needle 16 in which the catheter 12 and the inner needle 14 overlap in a state before use (initial state). The catheter assembly 10 </ b> A includes a support member 40 that slidably supports the double-structure needle 16 (catheter 12) at the distal end portion 31 of the inner needle hub 30.

Specifically, the catheter 12 of the catheter assembly 10A has a moderate flexibility and includes a lumen 12a extending in the axial direction. The total length of the catheter 12 is not particularly limited, but may be, for example, 14 to 500 mm, preferably 30 to 400 mm, or more preferably 76 to 200 mm.

The constituent material of the catheter 12 is preferably a soft resin material, for example, a fluorine-based resin such as polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), perfluoroalkoxy fluororesin (PFA), Examples thereof include olefinic resins such as polyethylene and polypropylene or mixtures thereof, polyurethane, polyester, polyamide, polyether nylon resin, mixtures of olefinic resins and ethylene / vinyl acetate copolymers, and the like.

The proximal end portion of the catheter 12 is fixed to the distal end portion in the catheter hub 20 by appropriate fixing means such as caulking, fusion, adhesion, and insert molding. The catheter hub 20 is exposed on the patient's skin in a state where the catheter 12 is inserted into the blood vessel of the patient, and the catheter hub 20 is affixed together with a tape or the like together with the support member 40. The catheter hub 20 is connected to other medical devices (fluid or blood transfusion tubes).

The catheter hub 20 is formed in a cylindrical shape that is harder than the catheter 12. The catheter hub 20 includes a distal taper portion 21 that tapers in the distal direction, and a proximal end body portion 22 that continues to the proximal end of the distal taper portion 21 and extends with a constant thickness. An operation tab 23 that protrudes radially outward is provided on the outer peripheral surface of the base end body 22 on the base end side. Although not shown, the catheter hub 20 may be provided with a flange for engaging with another medical device.

In the catheter hub 20, an internal space 20a communicating with the lumen 12a of the catheter 12 is formed. The internal space 20 a communicates with a proximal end opening 20 b provided at the proximal end of the catheter hub 20. In this internal space 20a, a hemostatic valve (not shown) that prevents leakage of blood that has flowed back when the double-structure needle 16 is punctured, and a plug (not shown) that allows infusion through the hemostasis valve when the connector of the infusion tube is inserted. Etc. may be accommodated.

The catheter hub 20 is accommodated in the inner needle hub 30 so as to be able to advance and retract in the initial state, and the operation tab 23 is directed upward in the accommodated state. The operation tab 23 is formed so as not to protrude from the upper surface of the inner needle hub 30 and to have a certain width in the circumferential direction so that the user's finger can easily come into contact therewith. Note that the operation tab 23 may protrude greatly from the upper surface of the inner needle hub 30 so as to be exposed upward.

The constituent material of the catheter hub 20 is not particularly limited. For example, a thermoplastic resin such as polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer may be applied.

On the other hand, the inner needle 14 is configured as a hollow tubular body having rigidity capable of puncturing the skin of a living body, and includes a sharp needle tip 15 at the tip. A hollow portion 14 a extending in the axial direction is provided inside the inner needle 14, and the hollow portion 14 a communicates with a tip opening 14 b provided in the needle tip 15.

Examples of the constituent material of the inner needle 14 include stainless steel, aluminum or aluminum alloy, metal material such as titanium or titanium alloy, hard resin, ceramics, and the like. The inner needle 14 is firmly fixed to the inner needle hub 30 by appropriate fixing means such as fusion, adhesion, and insert molding.

The inner needle hub 30 constitutes a grip portion that is held by a user such as a doctor or a nurse, and can be handled integrally with the inner needle 14. The inner needle hub 30 is a rectangular tube-shaped accommodation member having an accommodation space 30a on the inner side in which the catheter hub 20 and the support member 40 can be accommodated. Specifically, the inner needle hub 30 includes a lower wall 32, an upper wall 33 facing the lower wall 32, and both sides of the lower wall 32 and the upper wall 33 in a cross-sectional view orthogonal to the axial direction of the inner needle hub 30. And a pair of side walls 34 extending so as to surround the housing space 30a. Further, a proximal end wall 35 for fixing and holding the inner needle 14 is provided at the proximal end of the inner needle hub 30, and the accommodation space 30 a is closed by the proximal end wall 35. The inner needle hub 30 may include a needle holding portion that fixes the inner needle 14 in the accommodation space 30a.

The lower wall 32 of the inner needle hub 30 has a predetermined thickness and is formed in a flat plate shape that is continuous in series along the axial direction (longitudinal direction) of the inner needle hub 30. Alternatively, the lower wall 32 is formed in a shape that guides the advancement and retreat of the catheter hub 20 (for example, an arc shape that matches the cylindrical shape of the catheter hub 20) on the proximal side of the distal end portion 31 of the inner needle hub 30. May be.

The upper wall 33 is formed in a flat plate shape like the lower wall 32 and has a guide groove portion 36 extending from the midway position of the inner needle hub 30 in the axial direction to the tip. The guide groove portion 36 communicates the accommodating space 30a with the outside of the inner needle hub 30, and is in the initial state (the state before use and the needle tip 15 of the inner needle 14 protrudes from the distal end of the catheter 12). The operation tab 23 of the hub 20 is arranged. That is, the guide groove portion 36 has a function of allowing the user to contact the operation tab 23 and guiding the advancement and retraction of the operation tab 23. The guide groove 36 is formed to have a length corresponding to the movement range (the dimension of the catheter 12) of the catheter hub 20 in the inner needle hub 30, and a width capable of regulating the removal of the catheter hub 20 from the accommodation space 30a. Is formed. The inner edge 33a of the upper wall 33 constituting the guide groove portion 36 is formed in a taper shape that expands in the width direction from the accommodation space 30a side to the outside, thereby facilitating the user's finger. The proximal end of the guide groove portion 36 is provided at a position where the operation tab 23 of the catheter hub 20 abuts in the initial state and the catheter hub 20 does not move further to the proximal end side. It is also possible to provide means for restricting the movement of the catheter hub 20 in the axial direction, such as a protrusion, inside the inner needle hub 30.

The pair of side walls 34 are formed in a flat plate shape and have a slot 37 that holds the support member 40 at the distal end portion 31 of the inner needle hub 30. The slot 37 is formed to have a length corresponding to the entire length of the support member 40 and extends to the tip of the inner needle hub 30 (side wall 34). The slot 37 has a function of locking a wing 42 of the support member 40 to be described later and releasing the lock of the wing 42 when receiving a pressure from the support member 40 toward the distal end.

For example, the inner wall surface of the slot 37 is provided with an engaging convex portion 37a that slightly protrudes on the tip side from the wing 42 in the initial state. The engagement convex portion 37a has a base end side facing the wing 42 in the initial state formed at a steep angle and the opposite side formed at a gentle angle, so that the support member 40 advances in the front end direction. The engagement force is changed when the support member moves backward in the proximal direction. Note that the inner wall surface of the slot 37 may be formed with a groove width that does not include the engaging convex portion 37a and that imparts an appropriate frictional force to the wing 42 in the initial state.

Since the inner needle hub 30 constitutes a portion to be gripped by the user, it can also be called a gripping portion. The inner needle hub 30 may be composed of a single member or a plurality of members including a portion for fixing and holding the inner needle 14. In this case, the inner needle hub 30 includes the member including the portion for fixing and holding the inner needle 14 and the aforementioned member. The inner needle hub 30 is a rectangular tubular housing member, and the lower wall 32, the upper wall 33, and the pair of side walls 34 have been described as the wall structure. It can also be configured as a circular or oval wall. In this case, a part or the whole of a circular or elliptical wall is to be read as the above description in the configuration (the lower wall 32, the upper wall 33, and the pair of side walls 34) substantially corresponding to each.

The support member 40 is held on the distal end portion 31 side of the inner needle hub 30 in the initial state. The support member 40 supports the inner needle 14 via the catheter 12 when the double structure needle 16 (catheter 12) is punctured or when the catheter 12 is advanced, and further suppresses the deflection of the inner needle 14. Along with the movement, the catheter hub 20 and the inner needle hub 30 are detached together (see FIG. 6B). After the separation, the support member 40 is placed in the patient together with the catheter 12 and the catheter hub 20.

2A and 2B, the support member 40 includes a center tube 41 and a pair of wings 42 protruding outward in the width direction from the outer peripheral surface of the center tube 41. The center tube 41 is formed so as to project a substantially semicircular shape upward from a flat lower surface in a front view. The central cylinder 41 includes a distal end side cylindrical portion 43 that is tapered in the distal direction in plan view, and a proximal end side cylindrical portion 44 that is connected to the proximal end of the distal end side cylindrical portion 43 and is connected to a pair of wings 42. Have.

The central tube 41 has a space 45 that can accommodate the catheter hub 20 from the proximal tube portion 44 to the middle of the distal tube portion 43. The space portion 45 communicates with a proximal end opening 45 a provided at the proximal end of the central tube 41 and also communicates with an insertion support hole 45 c formed at the center portion of the distal end side tubular portion 43. As shown in FIG. 3A, the space portion 45 may be designed to have an appropriate shape corresponding to the outer shape of the inserted catheter hub 20, and in this embodiment, the space portion 45 extends in the distal direction according to the shape of the distal tapered portion 21. It is formed in a funnel shape with a gradually decreasing diameter.

The catheter hub 20 and the support member 40 have an engagement mechanism 18 that engages (integrates) with each other when the catheter hub 20 moves to the distal end portion 31 of the inner needle hub 30. In this embodiment, the engaging mechanism 18 has a structure in which the outer peripheral surface of the catheter hub 20 and the inner peripheral surface constituting the space portion 45 of the support member 40 are fitted with an appropriate frictional force.

Further, the base end side cylinder portion 44 is provided with a notch 46 having a predetermined axial length and width from the base end toward the tip and having a tip formed in an arc shape. The base end side of the central cylinder 41 is easily elastically deformed radially outward by the notch 46. Note that the engagement mechanism 18 is not limited to friction fitting, and for example, by providing a convex portion on one of the catheter hub 20 and the support member 40 and a concave portion on the other side, the convex portion is inserted into the concave portion and both (See also FIGS. 9C and 10A).

On the other hand, the insertion support hole 45c extends from the space 45 to the tip of the center tube 41 (tip opening 45b). The diameter of the insertion support hole 45 c is slightly larger than the outer diameter of the catheter 12 and smaller than the diameter of the distal end of the catheter hub 20. That is, the wall portion of the support member 40 constituting the insertion support hole 45c forms a slight gap with the catheter 12 to allow the catheter 12 to slide, and the inner needle 14 moves radially outward ( Bend).

As shown in FIGS. 2A to 4B, the pair of wings 42 of the support member 40 are formed so as to have a sufficient thickness with a length in the axial direction comparable to that of the proximal-side cylinder portion 44 in plan view. The The support member 40 is positioned in the initial state with respect to the distal end portion of the inner needle hub 30 by accommodating the pair of wings 42 in the pair of slots 37 of the inner needle hub 30, respectively. Further, each wing 42 protrudes outward in the width direction from the pair of side walls 34 of the inner needle hub 30.

The pair of wings 42 are connected to the lower side of the central cylinder 41 so that the lower surface of the central cylinder 41 and the lower surface of each wing 42 are flush with each other when viewed from the front. As a result, when the support member 40 is placed on the patient side, it can be placed on the patient's body surface so that the entire lower surface of the central cylinder 41 and the wing 42 are in surface contact with each other, thereby compressing a narrow range of the body surface. This can be suppressed.

The material constituting the support member 40 is not particularly limited, and for example, the material mentioned in the catheter hub 20 may be applied. In addition, the portion constituting the insertion support hole 45c in the distal end side cylindrical portion 43 of the support member 40 is more flexible than other portions (proximal end portion relative to the insertion support hole 45c) in order to prevent kinking of the catheter 12. It is preferable that the flexible portion 47 is configured. The entire support member 40 may be configured more flexibly than the catheter hub 20 or the like.

The catheter assembly 10A has an initial state as shown in FIG. 1 and FIG. In the initial state, the support member 40 is disposed at the distal end portion 31 of the inner needle hub 30 and can contact and support the double-structure needle 16 in which the inner needle 14 is inserted into the catheter 12. The catheter hub 20 is housed on the proximal end side of the inner needle hub 30 with the inner needle 14 inserted through the inner space 20a, and the operation tab 23 is disposed in the guide groove portion 36.

The catheter assembly 10A according to the first embodiment is basically formed as described above, and the operation thereof will be described below.

The catheter assembly 10A is used when constructing a transfusion or infusion introduction section as described above. In use, the user holds the inner needle hub 30 and punctures the patient with the double-structure needle 16. At the time of puncturing, the support member 40 supports the double structure needle 16 from the outside and suppresses the bending of the double structure needle 16.

In the puncture state of the double-structure needle 16, as shown in FIG. 5B, the user pushes out the catheter hub 20 by operating the operation tab 23 of the catheter hub 20 in the distal direction, and inserts the catheter 12 into the blood vessel. To go. At this time, the support member 40 prevents the inner needle 14 from being bent through the catheter 12 while guiding the movement of the catheter 12.

As shown in FIG. 5C, when the catheter hub 20 moves to the vicinity of the tip of the inner needle hub 30 as it advances, the catheter hub 20 enters the space 45 of the support member 40. At this time, the pair of wings 42 arranged in the pair of slots 37 has the engagement force by the engagement convex portion 37a slightly higher than the engagement force between the catheter hub 20 and the support member 40. The support member 40 is fitted well. Thereafter, when the support member 40 receives the advance output from the catheter hub 20, the engagement protrusion 37 a and the wing 42 are disengaged, and the wing 42 moves in the distal direction in the slot 37 of the inner needle hub 30. .

As shown in FIG. 6A, the catheter assembly 10A can also retract the catheter 12 once according to the user's intention. Even after the catheter hub 20 and the support member 40 are engaged with each other, the operation tab 23 of the catheter hub 20 is simply returned to the proximal direction, so that the pair of wings 42 get over the engagement convex portion 37a and Returning to the above, the backward movement of the support member 40 is restricted. Therefore, when the catheter hub 20 is pushed back in the proximal direction as it is, the engagement between the catheter hub 20 and the support member 40 is smoothly released.

Then, as shown in FIG. 6B, the user causes the catheter hub 20 and the support member 40 to be detached from the inner needle hub 30 as the catheter hub 20 advances or the inner needle hub 30 retracts. Thereby, the support member 40 is indwelled on the patient's body surface as an indwelling body in a state where the engagement with the catheter hub 20 is continued. At this time, the support member 40 can place the catheter 12 and the catheter hub 20 satisfactorily by attaching a tape or the like to the pair of wings 42.

As described above, the catheter assembly 10A according to the first embodiment is configured such that the support member 40 disposed at the distal end portion 31 of the inner needle hub 30 is detached integrally with the movement of the catheter hub 20, The handleability can be greatly improved. That is, the support member 40 suppresses bending of the inner needle 14 via the catheter 12 while sliding the catheter 12 when the catheter 12 and the inner needle 14 are punctured into the living body or when the catheter 12 is inserted into the blood vessel. . The support by the support member 40 continues well until the catheter 12 moves to the support member 40. Moreover, since the support member 40 is detached from the inner needle hub 30 as the catheter hub 20 moves, the inner needle 14 can be easily pulled out from the catheter hub 20. Therefore, the operation of the catheter assembly 10A is simplified, and it is possible to improve the efficiency of treatment by the user.

In addition, the catheter assembly 10A can more firmly integrate both members by engaging the catheter hub 20 and the support member 40 with the engagement mechanism 18. Then, the catheter hub 20 and the support member 40 can be stably placed on the patient side as an indwelling body.

Furthermore, the engagement mechanism 18 is a structure in which the outer peripheral surface of the catheter hub 20 and the inner peripheral surface of the support member 40 are fitted together, so that both members can be operated by a simple operation of causing the support member 40 to enter the catheter hub 20. Engagement can be realized.

Furthermore, the catheter assembly 10A includes the notch 46 in the support member 40, so that the proximal end portion of the support member 40 is easily elastically deformed when the catheter hub 20 enters the support member 40. . Thereby, the catheter hub 20 can be smoothly moved to the fitting position, and can be fitted to the support member 40 with an appropriate frictional force.

Here, the catheter assembly 10A has a portion where the support member 40 is engaged with the inner needle hub 30, so that the support member 40 can be prevented from dropping off in the initial state.

And as a part engaged with the inner needle hub 30, the support member 40 is provided with a pair of wings 42, so that the arrangement state of the support member 40 by the inner needle hub 30 can be easily and stably maintained. . Moreover, when the wing 42 is placed on the patient's body surface after being detached from the inner needle hub 30, the wing 42 can be used as a place where a compression area is reduced and a tape or the like is applied.

Then, the catheter assembly 10A inserts and guides a part (a pair of wings 42) of the support member 40 into the slot 37 of the inner needle hub 30 to smoothly move the support member 40, thereby allowing the inner needle hub to move. The detachment of the support member 40 from 30 can be further facilitated.

The catheter assembly 10A according to the present invention is not limited to the above-described embodiment, and various modifications and applications can be taken. For example, the support member 40 is not limited to a cylindrical shape that can accommodate the catheter hub 20, and may be any structure that can be engaged with the proximal end portion of the catheter 12 or the distal end of the catheter hub 20. For example, the base end portion of the catheter 12 may be formed thick and the support member 40 may be engaged with the base end portion, thereby allowing the support member 40 to function as a strain relief that prevents the catheter 12 from being kinked. Good.

Further, the support member 40 (engagement mechanism 18) may employ a structure that is hooked to the distal end of the catheter hub 20 or a structure that is attached to the catheter hub 20. Alternatively, the support member 40 may be formed in a shape that accommodates the entire catheter hub 20.

The support member 40 in the present embodiment has been described as an aspect having a pair of wings 42 in terms of maintaining the arrangement state of the support member 40 by the inner needle hub 30 and using it when placed on the patient's body surface. However, instead of the pair of wings 42, protrusions guided by grooves provided on the inner surface of the slot 37 or the side wall 34 of the inner needle hub 30 may be used. Such a protrusion can reliably maintain the arrangement state of the support member 40 by the inner needle hub 30. In this embodiment, the protrusion may be provided on the side wall 34 of the inner needle hub 30 and the groove may be provided on the support member 40.

[Second Embodiment]
As shown in FIGS. 7A to 7C, the catheter assembly 10B according to the second embodiment is provided with a catheter operation member 50 for operating the catheter 12 and the catheter hub 20 to move forward and backward. Different from the catheter assembly 10A according to the above. In the following description, elements having the same configuration or the same function as those of the above-described embodiment are denoted by the same reference numerals, and detailed description thereof is omitted.

Specifically, the catheter operation member 50 constitutes a connection part 51 connected to the outer peripheral surface of the catheter hub 20, a connection neck part 52 protruding from the connection part 51, and a part operated by the user connected to the connection neck part 52. And an operation unit 53.

The connecting portion 51 of the catheter operating member 50 is housed in the housing space 30a of the inner needle hub 30 together with the catheter hub 20 in an initial state. The connecting portion 51 is formed in a square shape corresponding to the cross-sectional shape of the accommodation space 30a of the inner needle hub 30 in a front view. Further, the connecting portion 51 has an axial length shorter than the proximal end barrel portion 22 of the catheter hub 20. A holding space 51 a that matches or is slightly smaller in diameter than the outer diameter of the catheter hub 20 is formed inside the connection portion 51. The catheter hub 20 inserted into the holding space 51a is engaged and held with an appropriate frictional force with the connecting portion 51. The connection portion 51 allows the catheter hub 20 to be pulled downward by the pair of leg portions 51b forming the holding space 51a being elastically opened in the width direction.

The connecting neck portion 52 of the catheter operating member 50 is formed to be narrower than the groove width of the guide groove portion 36 (see FIG. 1) of the inner needle hub 30, and connects the connecting portion 51 and the operating portion 53. Thereby, the operation part 53 is exposed to the outside of the inner needle hub 30.

The operation portion 53 is formed in a block shape above the inner needle hub 30 so as to expand in the width direction from the guide groove portion 36 of the inner needle hub 30. In addition, the operation portion 53 is formed to extend from the connection portion of the connection neck portion 52 in the distal direction so as to overlap the catheter hub 20 in plan view. As a result, the user's finger holding the inner needle hub 30 can easily reach the operation unit 53.

On the other hand, the catheter hub 20 has a restricting protrusion 22a for restricting movement of the connecting portion 51 of the catheter operating member 50 in the distal direction on the outer peripheral surface of the proximal end barrel portion 22. That is, the connecting portion 51 is sandwiched between the restricting protrusion 22a and the operation tab 23, and the movement in the axial direction with respect to the catheter hub 20 is restricted.

Further, in the catheter assembly 10 </ b> B, the support member 40 (engagement mechanism 18) that supports the double-structured needle 16 (catheter 12) has a catheter hub 20 on the distal end side relative to the connection portion of the connection portion 51 of the catheter operation member 50. The support member 40 and the catheter hub 20 are integrated by accommodating and engaging.

The catheter assembly 10B according to the second embodiment is basically configured as described above. As shown in FIGS. 8A and 8B, this catheter assembly 10 </ b> B is basically the first embodiment except that the user operates the catheter operation member 50 to advance or retract the catheter 12 and the catheter hub 20. The same operation as that of the catheter assembly 10A according to the embodiment is performed. That is, the catheter assembly 10 </ b> B can prevent the inner needle 14 from being bent by the support member 40 when the catheter 12 and the catheter hub 20 are moved even when the catheter operation member 50 is provided. The catheter hub 20 engages with the support member 40 at the time of advancement, and the catheter hub 20 and the support member 40 can be smoothly detached from the inner needle hub 30.

Further, as shown in FIG. 8C, the catheter operating member 50 is detached from the catheter hub 20 by the user after detaching the catheter hub 20 from the inner needle 14. Thereby, the indwelling body comprised with the catheter 12, the catheter hub 20, and the supporting member 40 is detained by the patient side.

In addition, the catheter operation member 50 is not limited to the above configuration, and various modifications can be taken. For example, the connecting portion 51 of the catheter operating member 50 is not only connected to the outer peripheral surface of the catheter hub 20, but is inserted into the inner space 20a from the proximal end opening 20b (see FIG. 7A) in the catheter hub 20 and fits. A configuration or the like may be used. Further, the catheter operating member 50 may be placed in the patient in an integrated manner with the support member 40 by engaging with the support member 40 at the time of advancement. Further, the catheter operation member 50 may be configured to be hooked on the needle tip 15 of the inner needle 14 and may not be detached from the waste body. In this case, the catheter operation member 50 may function as a safety member that prevents the inner needle 14 from being pierced by covering the needle tip 15 of the inner needle 14 when the indwelling body is detached.

[Third Embodiment]
In the catheter assembly 10C according to the third embodiment, as shown in FIGS. 1 and 9A to 10B, the support member 40A extends long along the axial direction, and the engagement position with the catheter hub 20 can be adjusted. It has become a structure. In the present embodiment, the catheter assembly 10C has a configuration in which the user directly operates the catheter hub 20 (the same configuration as in the first embodiment).

Specifically, the central cylinder 41 (base end side cylinder portion 44) of the support member 40A is formed in a cylindrical shape that extends longer than the axial length of the pair of wings 42, and corresponds to the total length of the central cylinder 41. The internal space 45 also extends long in the axial direction. Further, the notch 46 formed in the central cylinder 41 also extends from the proximal end of the central cylinder 41 to the vicinity of the distal end side cylinder portion 43. The pair of wings 42 are connected to the distal end of the proximal end side cylinder portion 44.

Further, a plurality of recesses 48 are formed on the inner peripheral surface of the support member 40A constituting the space 45. A pair of the recesses 48 are provided at positions that are 180 ° out of phase at the same position in the axial direction of the central cylinder 41, and a plurality of these recesses 48 are provided along the axial direction of the central cylinder 41 (three in the illustrated example). It is installed side by side. The concave portion 48 is engaged with a convex portion 24 of the catheter hub 20 described later, and constitutes an engagement mechanism 18A that defines an engagement position of the catheter hub 20 with respect to the support member 40A. The pair of recesses 48 arranged in the axial direction are provided at equal intervals (for example, 1 cm intervals). Hereinafter, the respective concave portions 48 arranged in the axial direction are referred to as a first concave portion 48a, a second concave portion 48b, and a third concave portion 48c in order from the proximal end toward the distal end side.

The catheter hub 20 that is inserted into the space 45 of the support member 40A has a pair of convex portions 24 that protrude from the outer peripheral surface of the proximal end barrel portion 22 radially outward. The pair of convex portions 24 are provided at positions that are 180 ° out of phase at the same position in the axial direction of the catheter hub 20 corresponding to the pair of concave portions 48 of the support member 40A. Accordingly, when the catheter hub 20 is inserted into the support member 40A, the pair of convex portions 24 can be engaged with the first to third concave portions 48a to 48c stepwise.

For example, in the support member 40A, the length of the catheter 12 protruding from the distal end of the support member 40A in a state where the pair of convex portions 24 of the catheter hub 20 are engaged with the pair of first concave portions 48a (see the solid line in FIG. 10B). Is set to the first length (for example, 8 cm). Further, the support member 40A has the first length of the catheter 12 protruding from the distal end of the support member 40A in a state where the pair of convex portions 24 are engaged with the pair of second concave portions 48b (see the thick dotted line in FIG. 10B). It is set to a second length (for example, 9 cm) that is longer than this. Furthermore, the support member 40A has the length of the catheter 12 protruding from the distal end of the support member 40A in a state where the pair of convex portions 24 are engaged with the pair of third concave portions 48c (see the thick dashed line in FIG. 10B). A third length (for example, 10 cm) longer than 2 is set.

As described above, even when the catheter assembly 10C has the convex portion 24 and the concave portion 48, both members can be engaged by causing the catheter hub 20 to enter the support member 40A. In particular, the support member 40A makes it possible to adjust the length of the catheter 12 in the indwelling state of the indwelling body constituted by the catheter 12, the catheter hub 20, and the support member 40A. Thereby, while inserting the catheter 12 from a patient's desired puncture site (for example, a site where blood vessels can be seen well on the skin), the catheter 12 having an appropriate length can be placed in the body according to the patient's body shape and the like. it can.

Further, the notch 46 of the support member 40A extends from the base end of the support member 40A to a position exceeding the third recess 48c, so that the support member 40A itself can be appropriately elastically deformed. By elastic deformation, the catheter hub 20 can be satisfactorily locked at an appropriate position (stepwise) while allowing the catheter hub 20 to move along the axial direction of the support member 40A. Furthermore, the catheter hub 20 and the support member 40A have

marks

25 and 49 on their outer peripheral surfaces that enable confirmation of positions where the pair of convex portions 24 engage with the pair of first to third concave portions 48a to 48c. It is preferable. The

marks

25 and 49 allow the user to check the length of the catheter 12 protruding.

Further, as shown by the dotted line in FIG. 10B, the support member 40A is connected to the first to third recesses 48a to 48c and includes a guide recess 48d for guiding the protrusion 24 of the catheter hub 20 in the axial direction. But you can. The guide recess 48d extends from the base end of the support member 40, and is formed so as to continue to the upper side or the lower side of the first to third recesses 48a to 48c. Thus, when the catheter hub 20 is moved in the axial direction of the support member 40A, the movement is first guided by positioning the convex portion 24 in the guide concave portion 48d, and when the catheter hub 20 and the support member 40A are engaged. The catheter hub 20 is slightly turned to insert the convex portion 24 at a position where the guide concave portion 48d and the first to third concave portions 48a to 48c are continuous. Thereby, the axial movement of the convex portion 24 and the engagement between the convex portion 24 and the concave portion 48 can be more smoothly performed.

Further, the engaging mechanism 18A may have a configuration in which the convex portion 24 is provided in the support member 40A, while the concave portion 48 is provided in the catheter hub 20. Furthermore, the catheter assembly 10C may be configured such that the catheter operation member 50 is connected to the catheter hub 20 and operated via the catheter operation member 50 (see the thin line in FIG. 10B), as in the second embodiment. . For example, the catheter operating member 50 may be configured to be inserted into the internal space 20a from the proximal end opening 20b of the catheter hub 20.

[Fourth Embodiment]
As shown in FIGS. 11, 12A, and 12B, the catheter assembly 10D according to the fourth embodiment is provided with an arm 71 that can be engaged with the inner needle hub 60 on the support member 70, and can push down the arm 71. This is different from the catheter assemblies 10A to 10C according to the first to third embodiments in that a pressing protrusion 81 is provided on the catheter hub 80.

Specifically, the side wall 61 of the inner needle hub 60 includes a slot 62 that communicates with the accommodation space 60a and extends from the tip of the inner needle hub 60 to a predetermined depth. A widened portion 63 in which a positioning projection 72 of a support member 70 to be described later is disposed is formed in the back portion on the proximal end side of the slot 62 in an initial state. An engaged surface 63 a on which the engaging surface 72 a of the positioning protrusion 72 is hooked is formed on the wall surface constituting the widened portion 63.

The support member 70 accommodated in the inner needle hub 60 is formed in a cylindrical shape without the wing 42, and includes an arm 71 (a hook portion) that can be engaged with the inner needle hub 60 on the outer peripheral surface of the support member 70. The arm 71 protrudes short in the radial direction from the outer peripheral surface in a plan view, bends at a bending point, and extends in the proximal direction. The arm 71 fits in the proximal end portion of the slot 62 of the inner needle hub 60 in the initial state.

The portion extending in the proximal direction in the arm 71 is formed in a flat plate shape having a certain width. Further, a positioning projection 72 that can be hooked on the side wall 61 of the inner needle hub 60 in a plan view is provided on the protruding end portion on the proximal end side of the arm 71. The positioning protrusion 72 is set to a predetermined ratio (for example, ½) of the width of the arm 71 and is provided on the arm 71 on the outer side in the width direction. Further, the positioning protrusion 72 is formed in a triangular shape having an engagement surface 72 a orthogonal to the plane of the arm 71 in a side view.

Further, the support member 70 includes a guide cutout 73 on the outer peripheral surface at a position facing the arm 71. The guide notch 73 communicates with the space portion 74 in the support member 70 and extends linearly from the base end of the support member 70 to the base end of the connecting portion of the arm 71.

On the other hand, the catheter hub 80 includes a pressing protrusion 81 that protrudes radially outward from the outer peripheral surface. The engaging mechanism 18 that engages the support member 70 and the catheter hub 80 has a structure that fits the inner peripheral surface of the support member 70 and the outer peripheral surface of the catheter hub 80 as in the first embodiment. ing.

The pressing protrusion 81 is formed in a right triangle shape having a top portion 81a on the distal end side, a hypotenuse 81b inclined from the top portion 81a in the proximal direction and downward, and a lower top portion 81c in a side view. When the catheter hub 80 is inserted into the support member 70, the pressing protrusion 81 protrudes from the guide notch 73 of the support member 70, but has a protruding length that does not reach the positioning protrusion 72 of the arm 71. ing. Therefore, when the guide protrusion 73 moves in the distal direction, the inclined side 81b of the pressing protrusion 81 contacts the arm 71 and presses the arm 71 downward.

The catheter assembly 10D according to the fourth embodiment is basically configured as described above. In the initial state, the catheter assembly 10D accommodates the arm 71 of the support member 70 in the slot 62 of the distal end portion 64 of the inner needle hub 60, and the engaging surface 72a of the positioning protrusion 72 is engaged with the inner needle hub 60. It is caught on the mating surface 63a. For this reason, the support member 70 is restricted from moving along the axial direction and rotating around the circumferential direction with respect to the inner needle hub 60, and is prevented from falling off from the inner needle hub 60. The catheter hub 80 is disposed on the proximal end side of the support member 70 in the inner needle hub 60.

When using the catheter assembly 10D, the user advances the catheter hub 80 in the distal direction with the double structure needle 16 punctured. At the time of advancement, the insertion support hole 70 a formed in the distal end side of the support member 70 slides the catheter 12 while suppressing the bending of the inner needle 14. Further, the support member 70 is inserted into the space 74 through the proximal end opening 70b when the catheter hub 80 advances.

As shown in FIGS. 13A and 13B, when the catheter hub 80 is made to enter the support member 70 to some extent, the pressing protrusion 81 of the catheter hub 80 enters the guide notch 73, and along the guide notch 73 in the distal direction. Moving. The pressing protrusion 81 brings the hypotenuse 81 b into contact with the base end of the arm 71 (a position adjacent to the positioning protrusion 72) while the guide notch 73 is moving. As a result, the proximal end (positioning protrusion 72) of the arm 71 is gradually pressed downward, but until the catheter hub 80 is fitted to the support member 70 to some extent, the engaging surface 72a and the engaged surface The engagement of 63a continues.

As shown in FIGS. 14A and 14B, when the catheter hub 80 and the support member 70 are fitted, the lower top portion 81c of the pressing projection 81 pushes down the arm 71, whereby the engaging surface 72a and the engaged surface 63a. Is just released (or by slightly advancing the catheter hub 80 relative to the support member 70). As a result, the support member 70 can move relative to the inner needle hub 60. That is, the arm 71 can move in the slot 62, and the catheter hub 80 and the support member 70 move integrally in the distal direction and are detached from the inner needle hub 60.

As described above, the catheter assembly 10D according to the fourth embodiment prevents the support member 70 from coming off by firmly engaging the inner needle hub 60 and the support member 70 with each other. Engagement with the moved catheter hub 80 can be facilitated. Then, when the catheter hub 80 and the support member 70 are engaged, or after the engagement, the support member 70 and the inner needle hub 60 are disengaged so that the catheter hub 80 and the support member 70 are well integrated and detached. It becomes possible to make it.

The catheter assembly 10D may include a plurality of arms 71 of the support member 70. In this case, the number of the slots 62 of the inner needle hub 60 and the pressing protrusions 81 of the catheter hub 80 are the same as the number of the arms 71. What is necessary is just to be provided.

In addition, this invention is not limited to the above-mentioned embodiment, A various change is possible along the summary of invention. For example, the catheter assemblies 10A to 10D may include a safety mechanism for preventing the inner needle 14 from being pierced after the

catheter hubs

20 and 80 are detached, and guide the movement of the catheter 12 in the blood vessel. You may provide the mechanism which inserts a guide wire and a guide wire.

Claims

A catheter;
A catheter hub for fixing and holding the catheter;
An inner needle removably inserted into the catheter;
A catheter assembly comprising: an inner needle hub that holds and fixes the inner needle;
A support member that suppresses bending of the inner needle while allowing the catheter to slide is disposed at the distal end portion of the inner needle hub,
The catheter assembly is characterized in that the support member is detached from the inner needle hub as the catheter hub moves.
The catheter assembly of claim 1.
The catheter hub and the support member include an engagement mechanism that engages the catheter hub and the support member when the catheter hub moves to the distal end portion.
The catheter assembly of claim 2,
The support member is configured to be integrated by accommodating a part of the catheter hub from the proximal end to the inside.
The catheter assembly, wherein the engagement mechanism is configured to fit the outer peripheral surface of the catheter hub and the inner peripheral surface of the support member.
The catheter assembly of claim 2,
The support member is configured to be integrated by accommodating a part of the catheter hub from the proximal end to the inside.
The engagement mechanism has a structure in which a convex portion provided in the other is inserted into a concave portion provided in one of the outer peripheral surface of the catheter hub and the inner peripheral surface of the support member. Assembly.
The catheter assembly according to claim 4.
The catheter assembly, wherein the engagement mechanism can engage the catheter hub at a plurality of positions in the axial direction of the support member.
The catheter assembly according to any one of claims 3 to 5,
The support member has a notch extending a predetermined length in the axial direction from the proximal end.
The catheter assembly according to any one of claims 1 to 6,
A catheter assembly comprising a catheter operating member for operating movement of the catheter and the catheter hub.
The catheter assembly according to any one of claims 1 to 7,
The catheter assembly, wherein the support member has a portion that detachably engages with the inner needle hub.
The catheter assembly according to claim 8.
The portion that releasably engages with the inner needle hub includes a pair of wings.
The catheter assembly according to claim 8.
The part that releasably engages with the inner needle hub includes a hook portion that is hooked on the inner needle hub in an initial state before puncturing the inner needle,
The said hook part cancels | releases a hook with the said inner needle hub in response to the movement of the said catheter hub. The catheter assembly characterized by the above-mentioned.
The catheter assembly according to any one of claims 8 to 10,
The inner needle hub has a slot extending from a predetermined position in the axial direction of the inner needle hub to the tip,
A catheter assembly, wherein a part of the support member is inserted into the slot to guide the movement of the support member.
A catheter;
A catheter hub for fixing and holding the catheter;
An inner needle removably inserted into the catheter;
An inner needle hub that holds and fixes the inner needle,
A support member that is disposed at the distal end of the inner needle hub and has a portion that detachably engages with the inner needle hub, and that suppresses the deflection of the inner needle while allowing the catheter to slide. A catheter assembly characterized by that.