WO2019188742A1

WO2019188742A1 - Catheter assembly

Info

Publication number: WO2019188742A1
Application number: PCT/JP2019/011966
Authority: WO
Inventors: 川▲崎▼麻奈美
Original assignee: テルモ株式会社
Priority date: 2018-03-29
Filing date: 2019-03-22
Publication date: 2019-10-03
Also published as: JP7234210B2; JPWO2019188742A1

Abstract

A catheter assembly (10) includes a catheter (12), an inner needle (14), a catheter hub (20), and a catheter manipulating member (70). The catheter assembly (10) also has a support portion (17) that supports the catheter (12) by contacting an outer circumferential surface of the catheter (12), and the support portion (17) is capable of changing a support position of the catheter (12) in an axial direction in an initial state before the catheter (12) moves relative to the inner needle (14).

Description

Catheter assembly

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

Japanese Patent No. 5836931 discloses a catheter assembly having a double-structure 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 catheter assembly disclosed in Japanese Patent No. 5836931 includes a long inner needle hub and a long flat plate-like catheter operating member, and the catheter is supported by the inner needle hub and the catheter operating member. . As a result, the double-structure needle (catheter) is restrained from bending at the time of puncture or insertion into the blood vessel.

By the way, in this type of catheter assembly, when the distal end region of the double-structure needle exposed from the inner needle hub and the catheter operation member is long, for example, the double-structure needle is punctured into a blood vessel at a shallow location from the patient's body surface. At this time, the catheter is easily bent (that is, the operability is lowered). On the other hand, if the tip region of the double structure needle is short, the inner needle hub and the catheter operation member are likely to hit the body surface when the double structure needle is punctured into a blood vessel located deep from the patient's body surface. As a result, the operability is lowered.

The present invention has been made in connection with the above-described technique, and can easily puncture and insert a catheter according to a patient's condition by making it possible to easily change a portion that supports the catheter in an initial state. It is an object of the present invention to provide a catheter assembly that can be used.

In order to achieve the above object, the present invention comprises a catheter, an inner needle that is removably inserted into the catheter, a catheter hub that fixes and holds the proximal end of the catheter, the catheter, and the catheter hub. A catheter operating member that moves relative to the inner needle, and has a support part that supports the catheter by contacting an outer peripheral surface of the catheter, In the initial state before the catheter moves relative to the inner needle, the support position in the axial direction of the catheter can be changed.

In this case, the support portion may include a distal end side support portion provided at a distal end portion of the catheter operation member, and a proximal end side support portion provided closer to the proximal end side than the distal end side support portion. .

In the initial state, it is preferable that a housing member for housing the proximal end side of the catheter is provided, and the proximal end support portion is provided on the housing member.

Furthermore, the catheter operation member may extend in the distal direction from the distal end of the accommodating member, and may have the distal end side support portion in a portion exposed from the accommodating member.

In addition to the above configuration, the catheter operation member may include an operation part side separation mechanism that separates the distal end side support part from the catheter.

Alternatively, in the initial state, the housing member has a wall portion disposed on the outer side in the width direction of the distal end side support portion, and the wall portion receives an external force by contacting the outer side of the distal end side support portion. It is good also as a structure to add.

In this case, it is preferable that the housing member has a housing member side separation mechanism that separates the wall portion from the tip side support portion.

And the said base end side support part can support the lower side of the said catheter in the accommodation state of the said accommodation member, and external force is provided at the time of the movement of the said catheter operation member, and it rotates from the said accommodation member. It may be a support member that allows the catheter hub to be detached.

In order to achieve the above object, the present invention comprises a catheter, an inner needle that is removably inserted into the catheter, a catheter hub that fixes and holds the proximal end of the catheter, the catheter, and the catheter hub. A catheter operating member that is moved relative to the inner needle, wherein the catheter operating member is in a non-contact position with the outer peripheral surface of the catheter in a natural state, and an external force is applied to the catheter assembly. And a support body that elastically deforms toward the catheter and contacts the outer peripheral surface of the catheter.

In this case, it is preferable that the support has a pair of arms capable of forming a space surrounding the outer peripheral surface of the catheter in a front view.

Further, the pair of arms may have a gripping convex portion that protrudes outward of the pair of arms and constitutes a portion that receives the external force by gripping by the user.

Alternatively, an accommodation member that accommodates the proximal end side of the catheter is provided, and the accommodation member has a wall portion that is disposed on the outer side in the width direction of the pair of arms, and the wall portion is outside the pair of arms. It can be set as the structure which applies the said external force by contacting.

According to the present invention, the catheter assembly can appropriately support the catheter according to the patient's condition because the support portion can change the support position in the axial direction of the catheter in the initial state. As a result, when the catheter and the inner needle are punctured into the living body or when the catheter is inserted into the body, the extended state of the catheter and the inner needle can be satisfactorily maintained, and the user can suppress the deflection of the catheter. Thus, the catheter can be moved smoothly.

In addition, the catheter assembly has a support body that elastically deforms toward the catheter and contacts the outer peripheral surface of the catheter, thereby favorably supporting the catheter at an appropriate position of the catheter operation member and suppressing the deflection of the catheter. can do.

It is a perspective view showing the whole catheter assembly composition concerning a 1st embodiment of the present invention. FIG. 2 is an exploded perspective view of the catheter assembly of FIG. 1. It is a perspective view which shows the structure of the lower surface side of a catheter operation member. FIG. 4A is a front view showing the support in a natural state. FIG. 4B is a front view showing the support in the gripping state of the user. FIG. 5A is a perspective view showing the catheter assembly in an initial state. FIG. 5B is a perspective view showing a state where the distal end side plate portion of the catheter operating member is separated from the catheter. FIG. 6A is a plan view showing an operation portion side separation mechanism of the catheter operation member. 6B is a cross-sectional view taken along line IVB-IVB in FIG. 6A. FIG. 6C is a cross-sectional view showing a state where the distal end side plate portion is separated from the proximal end side plate portion. FIG. 7A is a first side view showing a rotation shaft support portion. FIG. 7B is a second side view showing the rotation shaft support portion. FIG. 7C is a side view showing the thin portion. FIG. 7D is a first side view showing the slide mechanism. FIG. 7E is a second side view showing the slide mechanism. It is a fragmentary perspective view which shows the support member of a catheter assembly. FIG. 9A is a first plan view of the inner needle hub and the support member as viewed from the lower surface. FIG. 9B is a second plan view showing the operation of the support member. FIG. 10A is a first explanatory view showing the operation of the catheter assembly. FIG. 10B is a second explanatory diagram illustrating the operation of the catheter assembly. FIG. 11A is a third explanatory view showing the operation of the catheter assembly. FIG. 11B is a fourth explanatory view showing the operation of the catheter assembly. It is a perspective view which shows the whole structure of the catheter assembly which concerns on 2nd Embodiment of this invention. It is a front view which shows the support body accommodated between a pair of side walls. FIG. 14A is a first planar cross-sectional view showing a slide mechanism portion. FIG. 14B is a second planar cross-sectional view showing the slide mechanism portion. FIG. 14C is a first cross-sectional view showing a thin portion and a cutout portion. FIG. 14D is a second planar cross-sectional view illustrating the thin portion and the cut portion.

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 10 according to the first embodiment includes a catheter 12 that is inserted into the body from outside the patient's body, and the catheter 12 constructs a transfusion or blood transfusion introduction section 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.).

As shown in FIGS. 1 and 2, in addition to the catheter 12, the catheter assembly 10 includes an inner needle 14 that is removably inserted into the catheter 12, a catheter hub 20 that fixes and holds the catheter 12, and an inner needle 14. Is provided with an inner needle hub 30 (accommodating member). Further, the catheter assembly 10 includes a tubular auxiliary member 50 inserted between the catheter 12 and the inner needle 14, an auxiliary member hub 52 for fixing and holding the auxiliary member 50, and a base of the catheter hub 20 and the auxiliary member hub 52. A needle protection member 60 connected to the end, and a catheter operation member 70 for operating the catheter 12 and the catheter hub 20 are provided.

The catheter assembly 10 constitutes a multi-structure needle 16 in which the catheter 12, the auxiliary member 50, and the inner needle 14 overlap from the outside to the inside in a state before use (initial state). In the catheter assembly 10, the entire length of the catheter operation member 70 is formed to be sufficiently long corresponding to the axial length of the catheter 12, and the catheter operation member 70 extends to the distal end side from the inner needle hub 30. The catheter 12 is supported.

Specifically, the catheter 12 of the catheter assembly 10 has a moderate flexibility and includes an inner 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, and adhesion. 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 is affixed with a tape or the like. The catheter hub 20 is connected to other medical devices (fluid or blood transfusion tubes).

The catheter hub 20 has a cylindrical shape that is tapered in the distal direction, is formed to be harder than the catheter 12, and includes a flange portion 21 that protrudes radially outward on the outer peripheral surface of the proximal end. An internal space 20 a communicating with the lumen 12 a of the catheter 12 is formed inside 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 multi-structure needle 16 is punctured, a plug (not shown) that allows infusion through the hemostasis valve as the connector of the infusion tube is inserted, etc. May be accommodated.

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 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 has a lower wall 31 and a pair of side walls 32 protruding upward from the side of the lower wall 31, and has an elongated hook-like shape extending shorter than the axial length of the inner needle 14. . On the inner side surrounded by the lower wall 31 and the pair of side walls 32, an accommodation space 30a for accommodating a part of the multi-structure needle 16, the catheter hub 20, the auxiliary member hub 52, and the needle protection member 60 is formed. The resin material which comprises the inner needle hub 30 is not specifically limited, For example, the material raised with the catheter hub 20 can be selected suitably.

The lower wall 31 is formed in a plate shape having a predetermined thickness and extending in the axial direction, and includes a needle holding portion 33 at the base end side and in the center in the width direction. The needle holding portion 33 protrudes upward from the lower wall 31 and firmly holds the proximal end portion of the inner needle 14 at a predetermined height position.

The pair of side walls 32 extend in parallel to the longitudinal direction of the lower wall 31 and have groove-shaped rail portions 34 on the inner surface on the distal end side formed higher than the proximal end side. The pair of rail portions 34 are connected to the upper surface on the proximal end side of each side wall 32, and slidably accommodate the side edge 71 a of the catheter operation member 70. One of the pair of side walls 32 (the left side wall 32 in FIG. 1) has a bulging portion 35 bulging outward in the width direction, and a support member 40 described later is attached to the bulging portion 35. An arrangement recess 36 is formed.

The arrangement recess 36 is cut out from the distal end of the side wall 32 toward the proximal direction, and is located between the lower wall 31 and the rail portion 34. A pair of support hole portions 36a to which the support member 40 is rotatably attached are provided in the lower wall 31 and the side wall 32 where the arrangement recess 36 is formed.

The auxiliary member 50 of the catheter assembly 10 has a function of supporting the catheter 12 from the inside and assisting the insertion of the catheter 12 into the blood vessel. The auxiliary member 50 is formed in a hollow tube having an outer diameter smaller than the inner diameter of the catheter 12 and an inner diameter larger than the outer diameter of the inner needle 14. The base end portion of the auxiliary member 50 is fixed to the auxiliary member hub 52 by appropriate fixing means (caulking, fusing, bonding, etc.).

The distal end side of the auxiliary member hub 52 is detachably inserted into the catheter hub 20, and the needle protection member 60 is detachably assembled to the proximal end side thereof. The auxiliary member hub 52 may be integrated with the needle protection member 60. The catheter assembly 10 may not include the auxiliary member 50 and the auxiliary member hub 52. In this case, the needle protection member 60 may be directly attached to the proximal end side of the catheter hub 20.

In the initial state, the needle protection member 60 is disposed so that the inner needle 14 is slidable. Then, as the inner needle 14 moves backward with respect to the catheter 12, the moved needle tip 15 is accommodated inside to prevent re-exposure of the needle tip 15. The needle protection member 60 houses a shutter 61 and a retaining member 62 inside to prevent re-exposure of the needle tip 15. The shutter 61 is elastically deformed in contact with the outer peripheral surface of the inner needle 14 in the initial state of the inner needle 14, and is elastically restored when the needle tip 15 is removed, thereby blocking the through path of the inner needle 14. The retaining member 62 has a hole (not shown) having a smaller diameter than the needle tip 15 of the inner needle 14, thereby restricting the needle tip 15 from coming out in the proximal direction.

The catheter operating member 70 holds the catheter 12 directly and is attached to the catheter hub 20 to move the catheter 12 and the catheter hub 20 relative to the inner needle 14 and the inner needle hub 30. As shown in FIGS. 2 and 3, the catheter operation member 70 is integrally formed with an operation plate portion 71 extending in the longitudinal direction of the inner needle hub 30 and a proximal end of the operation plate portion 71 and is detachable from the catheter hub 20. And a hub mounting portion 72 to be mounted.

The operation plate portion 71 is a portion where the user's finger is applied to perform advance / retreat operation, and is formed in a substantially rectangular shape in plan view. The longitudinal length of the operation plate 71 is set to be slightly shorter than the axial lengths of the catheter 12 and the inner needle 14 in correspondence with the axial length of the catheter 12 formed to be long. In the initial state, the operation plate portion 71 extends farther in the distal direction than the distal end of the inner needle hub 30 (see also FIG. 1).

Further, the operation plate portion 71 is formed to be sufficiently thin so that it can be bent in a direction perpendicular to the surface direction of the operation plate portion 71 (that is, a direction away from the catheter 12 and the inner needle 14). . The material which comprises the operation board part 71 (catheter operation member 70) is not specifically limited, For example, the material raised with the catheter hub 20 can be selected suitably.

The pair of side edges 71a extending along the longitudinal direction of the catheter operating member 70 are initially exposed from the inner needle hub 30, a portion disposed on the pair of rail portions 34, and the rail portion 34. And a portion disposed on the upper surface of the side wall 32 closer to the base end side. Moreover, as shown in FIG. 1, the notch part 73 notched in the width direction inside is provided in the base end side of the side edge 71a of one side (the installation location side of the support member 40).

Furthermore, an upper rib 74 and a tab 75 are provided on the upper surface of the operation plate portion 71, and a tip warp portion 76 is provided at the tip of the operation plate portion 71. A plurality of the upper ribs 74 are provided along the longitudinal direction of the operation plate portion 71 and extend linearly along the width direction of the operation plate portion 71, thereby increasing the strength in the width direction of the operation plate portion 71. The tab 75 is a part that assumes that the user's finger is directly applied when operating the catheter operation member 70, and protrudes higher than the upper rib 74.

As shown in FIG. 3, the tip warp portion 76 is formed thick on the lower surface side of the operation plate portion 71 and is curved while becoming thinner toward the tip and upward. An insertion groove 76a in which the catheter 12 is arranged in a non-contact manner or with a weak frictional force is formed in the center portion in the width direction of the distal end warped portion 76. As the catheter operation member 70 advances, the distal end warp portion 76 guides the operation plate portion 71 obliquely upward when the warped lower surface side contacts the patient.

Further, a plurality of lower ribs 77 are provided on the lower surface of the operation plate 71 along the axial direction. The lower rib 77 extends along the width direction similarly to the upper rib 74, and has a function of increasing the strength in the width direction of the operation plate portion 71. Moreover, the lower rib 77 suppresses the upward deflection of the catheter 12 (multiple structure needle 16) by contacting the catheter 12 extending below the operation plate 71.

A support body 80 for holding (supporting) the multi-structure needle 16 is provided at the distal end portion 78 of the operation plate portion 71 of the catheter operation member 70. The support 80 constitutes a user's gripping position at the distal end portion 78 of the operation plate portion 71, and has a function of directly transmitting the user's gripping force to the multi-structure needle 16 and holding the multi-structure needle 16. Therefore, the support body 80 is configured to be elastically deformable along the width direction with respect to the operation plate portion 71.

Specifically, as shown in FIGS. 3, 4A and 4B, the support body 80 includes a base 81 connected and fixed to the operation plate 71, and a pair of arms 82 connected and fixed to the base 81. Have. The material constituting the support 80 is not particularly limited as long as it has an appropriate elastic force. For example, a soft material (soft material) such as silicone rubber or low density polyethylene (LDPE) may be applied. . Alternatively, the support 80 may be integrally formed by applying the same material as that of the operation plate portion 71.

Since the base 81 is formed in a block shape, it has an appropriate rigidity and supports the pair of arms 82 in a resiliently suspended manner. Further, the base 81 projects a predetermined length from the lower surface of the catheter operation member 70, thereby defining the distance between the lower surface of the operation plate portion 71 and the catheter 12 when the support 80 holds the multi-structure needle 16. To do.

The pair of arms 82 is configured to be elastically deformable along the width direction of the operation plate portion 71, and the arms 82 move relative to the base 81. The arms 82 are naturally formed in an expanded state that opens outward in the width direction, while being deformed inward in the width direction by the gripping force when gripped by the user. Form. Specifically, the pair of arms 82 includes a connection base portion 83 that is continuous with the lower surface of the base 81, a relay portion 84 that is continuous with the connection base portion 83, and a hold portion 85 that is continuous with the relay portion 84.

The connection base 83 extends in a natural state so as to incline downward and outward in the width direction from the base 81, and the relay portion 84 and the hold portion 85 are disposed at the outer position. The connection base 83 is a portion that is elastically deformed relative to the base 81 toward the inner side in the width direction based on a gripping force (external force) when the user grips the pair of arms 82. Therefore, for example, the connection base 83 may be configured more flexibly than other parts (base 81, relay unit 84, hold unit 85).

The pair of connection bases 83 are formed in an inclined state in which the mutual angle is sufficiently large (for example, 135 ° or more) in a natural state, so that the protruding end portions 85a of the pair of hold portions 85 are separated greatly. Let At the time of elastic deformation, the linking force is generated on the radially outer side because the meat of the coupling base 83 is moved toward the inner side.

The relay portion 84 is formed to be bent at a predetermined angle with respect to the connection base portion 83. The relay portion 84 includes a gripping convex portion 86 that protrudes outward in the width direction with respect to the outer surface of the connection base portion 83. The pair of gripping convex portions 86 constitutes a gripping planned portion to which a user's finger comes into contact and a gripping force is applied, and the protruding ends thereof are formed on a flat surface 86a (or a structure that increases frictional force such as an uneven shape). ing. The flat surface 86a of the gripping convex portion 86 is positioned on the outer side in the width direction with respect to the side edge 71a of the operation plate portion 71 in a natural state, and is inclined obliquely. When the arm 82 grips the multi-structure needle 16 as the user grips, the pair of flat surfaces 86a move to positions where they are substantially parallel to each other.

The hold portion 85 is bent at a predetermined angle with respect to the relay portion 84 and extends inward in the width direction and downward. The pair of holding portions 85 move to the lower side of the catheter 12 as the user grips, and the gap between the projecting end portions 85a becomes narrower than the outer diameter of the catheter 12, whereby the catheter 12 at the time of gripping. Is restricted from falling downward. That is, the support body 80 constructs a state in which the catheter 12 is held on the inner side surface 82a by the shapes of the connection base portion 83, the relay portion 84, and the hold portion 85.

Note that the shape of the support 80 is not particularly limited, and may be formed in various shapes. For example, the support 80 may include a mechanism (such as a slit 81a indicated by a dotted line in FIG. 4A) that promotes elastic deformation of the arm 82 on the base 81, the connecting base 83, or the like. Further, the inner peripheral surface of the arm 82 may be formed in an arc shape according to the outer peripheral surface of the catheter 12. In addition, the catheter operation member 70 includes one or more holding portions (not shown) for holding a midpoint of the multi-structure needle 16 (catheter 12) on the lower surface of the operation plate portion 71 and on the proximal side of the support body 80. It may be. For example, the holding portion may be formed of a pair of protruding pieces that protrude downward from the lower surface of the operation plate portion 71, and may be formed so as to sandwich the catheter 12 between the inner side surfaces thereof.

As shown in FIGS. 5A and 5B, the operation plate portion 71 of the catheter operation member 70 is provided with an operation portion side separation mechanism 88 that separates the operation plate portion 71 itself from the multi-structure needle 16. The operation portion side separation mechanism 88 is formed at a position slightly ahead of the tip of the inner needle hub 30 in the initial state. In the initial state, the operation portion side separation mechanism 88 separates a portion on the distal end side of the operation plate portion 71 exposed from the inner needle hub 30 (hereinafter referred to as the distal end side plate portion 89) from the multi-structure needle 16. As a result, the catheter 12 is advanced and retracted by the proximal end portion of the operation plate 71 (hereinafter referred to as the proximal end plate 90).

That is, the catheter assembly 10 has a support portion 17 that can change the support position of the catheter 12 by arbitrarily switching the longitudinal length of the catheter operation member 70 by the user (see also FIG. 1). The support portion 17 is a support body 80 which is a distal end side support portion 18 provided at the distal end portion 78 of the catheter operation member 70 and a proximal end side support portion 19 provided at the distal end portion in the inner needle hub 30. And a support member 40. The support body 80 supports the catheter 12 at the first position P1 on the distal end side of the catheter operation member 70, and the support member 40 is on the proximal side from the first position P1 (substantially axial intermediate position of the multi-structure needle 16). To support the catheter 12.

The catheter assembly 10 can select a support position arbitrarily by the user because the distal end side plate portion 89 and the proximal end side plate portion 90 are continuous in the initial state. For example, the user can puncture the multi-structure needle 16 while holding the support 80 of the catheter operation member 70 and supporting the catheter 12. Alternatively, the user can puncture the multi-structure needle 16 with the support member 40 supporting the catheter 12 by separating the distal end side plate portion 89 from the catheter 12 by the operation portion side separation mechanism 88. Further, when using the catheter assembly 10, the user first supports the catheter 12 by the support 80 and punctures the multi-structure needle 16, and performs an operation of separating the distal side plate portion 89 as the catheter 12 is inserted. You can also

As shown in FIGS. 6A to 6C, the operation portion side separation mechanism 88 is configured by a cutout portion 91 that extends along the width direction of the operation plate portion 71. The cut-out portion 91 can be configured by drilling a plurality of holes 91a in the dotted line shape with respect to the operation plate portion 71. Accordingly, the cutout portion 91 can be easily cut by a user's manual operation, and the distal end side plate portion 89 is separated from the proximal end side plate portion 90.

In addition, the operation part side separation mechanism 88 is not limited to the cutout part 91, and various configurations can be adopted. For example, as in the first modification shown in FIGS. 7A and 7B, the operation portion side separation mechanism 88 includes a rotation shaft support portion 92 that rotatably supports the distal end side plate portion 89 with respect to the proximal end side plate portion 90. But you can. Further, in the configuration having the rotation shaft support portion 92, it is preferable to provide a posture maintaining mechanism 93 in order to maintain the posture of the distal end side plate portion 89 after the rotation.

For example, the posture maintaining mechanism 93 can be configured such that one of the distal end side plate portion 89 and the proximal end side plate portion 90 is provided with an engagement piece 93a and the other is provided with an engaged piece 93b. The engaged piece 93 b includes a hole 93 b 1 into which the head of the engaging piece 93 a is inserted, and forms an engaged state with the engaging piece 93 a as the distal end side plate portion 89 rotates.

Further, as in the second modified example shown in FIG. 7C, the operation portion side separation mechanism 88 is sufficiently larger than the thickness of the portion where the distal end side plate portion 89 and the proximal end side plate portion 90 extend (for example, 1 It may be configured as a thin wall portion 94 having a thin wall thickness (less than / 2). For example, the thin portion 94 is configured by connecting the upper surface side of the operation plate portion 71 and notching the lower surface side. The thin-walled portion 94 is configured to fold the operation plate portion 71 along the formation line in the width direction (the same function as the rotation shaft support portion 92), or configured to separate the distal end side plate portion 89 from the proximal end side plate portion 90 (cutout portion). 91).

In FIG. 7C, as another posture maintaining mechanism 93A, a configuration is shown in which an engaging convex portion 93c is provided on one of the distal end side plate portion 89 and the proximal end side plate portion 90, and an engaged concave portion 93d is provided on the other side. .

Further, for example, as in the third modification shown in FIGS. 7D and 7E, the operation portion side separation mechanism 88 is configured as a slide mechanism portion 95 that retreats the distal end side plate portion 89 relative to the proximal end side plate portion 90. May be. In this case, the base end side plate portion 90 includes a guide portion 95a for guiding the slide, and the engaging portion 95b and the engaged portion that engage the tip end side plate portion 89 and the base end side plate portion 90 in the tip end direction so as not to be detached. What is necessary is just to set it as the structure which has 95c.

As described above, the support position of the catheter 12 can be easily changed by providing the engaging portion for engaging the distal end side plate portion 89 with the catheter assembly 10 after the distal end side plate portion 89 is separated from the catheter 12. And the number of parts discarded after use of the catheter assembly 10 can be reduced.

1 and 2, the hub mounting portion 72 of the catheter operation member 70 has a pair of side plates 96 projecting downward from the operation plate portion 71 and a semi-cylindrical shape projecting somewhat upward from the operation plate portion 71. The upper plate 97 is formed in a box shape. Inside the pair of side plates 96 and the upper plate 97, a mounting chamber 72a that accommodates the distal end portion of the catheter hub 20 and is integrated with the catheter hub 20 is provided. The mounting chamber 72 a is opened toward the lower side of the hub mounting portion 72.

A concave groove (not shown) for accommodating the annular protrusion 22 provided at the distal end of the catheter hub 20 is formed on the inner surface of the side plate 96 constituting the mounting chamber 72a. For this reason, the hub mounting part 72 regulates and accommodates the movement of the catheter hub 20 in the distal and proximal directions.

As shown in FIGS. 2 and 8, in the catheter assembly 10, the support member 40 constituting the proximal end support portion 19 has a function of supporting the lower side of the catheter 12 at the distal end portion in the inner needle hub 30. The support member 40 includes a cylindrical shaft bar portion 41 and a support main body portion 42 that protrudes laterally from the shaft rod portion 41 (in a direction orthogonal to the axis of the shaft rod portion 41). Can be assembled freely.

The shaft rod portion 41 extends short in the vertical direction, and the upper end portion and the lower end portion thereof are inserted into the upper and lower support hole portions 36 a of the placement recess 36, respectively. On the upper side of the shaft bar portion 41, a cam convex portion 43 for rotating the support member 40 is integrally formed. The shaft bar portion 41 and the cam convex portion 43 have an operation member groove portion 43 a extending in a direction orthogonal to the shaft rod portion 41 at a position facing the support main body portion 42. The operating member groove 43a slidably accommodates the side edge 71a of the catheter operating member 70 together with the rail portion 34.

On the other hand, the support main body portion 42 is formed in an S-shape having a size substantially coincident with the vertical width of the placement concave portion 36 in a front view, and has a spring force that can be elastically deformed in the vertical direction. As shown in FIGS. 9A and 9B, the support main body 42 is positioned in the accommodation space 30a and supports the catheter 12 in an initial state. When the hub mounting portion 72 of the catheter operation member 70 comes into contact with the advancement, the support main body portion 42 rotates around the shaft rod portion 41 to enable the catheter operation member 70 to be detached. Further, a locking projection 44 is formed to project from the lower surface of the support body 42. The locking projection 44 is inserted into the locking recess 36b of the inner needle hub 30 when the support main body 42 rotates. Thereby, the position after the support member 40 is rotated is maintained with an appropriate force.

In addition, the structure of the base end side support part 19 is not limited to the support member 40, You may apply various structures. For example, the catheter assembly 10 can be configured to be sandwiched between the lower surface of the catheter operation member 70 and the lower wall 31 of the inner needle hub 30 (that is, a configuration in which the sandwiched portion serves as the proximal end side support portion 19). .

The catheter assembly 10 according to the present embodiment is basically configured as described above, and the usage method will be described below.

The catheter assembly 10 is used when a blood transfusion or an infusion part is constructed in a patient as described above. As shown in FIGS. 1 and 2, the catheter assembly 10 is in a product provision state (initial state before the catheter 12 is advanced), and the catheter 12, the auxiliary member 50, and the inner needle 14 are overlapped so that the multi-structure needle 16. Is configured. The multi-structure needle 16 extends below the catheter operation member 70 and protrudes relatively short from the distal end of the catheter operation member 70 in the distal direction. In an initial state, the catheter hub 20 and the auxiliary member hub 52 are connected to each other, the auxiliary member hub 52 and the needle protection member 60 are connected, and the catheter hub 20 is received in the hub mounting portion 72 of the catheter operation member 70. Is done.

In the initial state, the support portion 17 of the catheter assembly 10 includes a first position P1 where the support member 80 of the catheter operating member 70 is provided, and a second position P2 where the support member 40 of the inner needle hub 30 is provided. Thus, the multi-structure needle 16 can be supported.

The user of the catheter assembly 10 selects the gripping position of the catheter assembly 10 while viewing the patient's condition (blood vessel position) in use. In the following, with reference to FIGS. 10A to 11B, when the patient's blood vessel is at a deep position from the skin, the distal end side support portion 18 (first position P1) and the proximal end side support portion 19 (second end) are used during use. A use example for switching the position P2) will be described.

In this case, the user grasps the support 80 at the distal end portion 78 of the catheter operation member 70 at the start of puncturing, and punctures the multi-structure needle 16 into the blood vessel. That is, the user moves the pair of arms 82 that have been separated from the catheter 12 in a natural state to the inside by contacting the outer peripheral surface of the catheter 12 by gripping the gripping convex portions 86 of the pair of arms 82 with a finger ( 4A and 4B). As a result, the multi-structure needle 16 is held inside the pair of arms 82, and the portion protruding from the distal end side of the support body 80 is shortened. Therefore, even when a reaction force is applied from the living tissue when puncturing the multi-structure needle 16, bending is suppressed, and insertion into the body can be performed smoothly.

At the time of puncturing, the catheter assembly 10 has a deep blood vessel of the patient, so that the distal end portion 78 (support 80) of the catheter operation member 70 hits the body surface. Therefore, as shown in FIG. 10B, the user moves the handle from the support body 80 to the proximal end side (inner needle hub 30) of the catheter assembly 10. Thereby, the support body 80 is elastically restored to the outer side in the width direction and separated from the catheter 12 (becomes a natural state). Even in this state, the support member 40 of the inner needle hub 30 continues to support the catheter 12 at the second position P2. Therefore, the bending of the multi-structure needle 16 can be sufficiently suppressed.

In particular, after the puncture, the insertion direction of the multi-structure needle 16 with respect to the patient is fixed, and the multi-structure needle 16 is smoothly inserted toward the blood vessel even if the advance force is given from the inner needle hub 30 held by the user. be able to. Further, the catheter operation member 70 is released from the grasping by the user, and when the distal end portion 78 hits the body surface, the catheter operation member 70 is deformed so as to bend naturally and is separated from the catheter 12.

Then, as shown in FIG. 11A, when the needle tip 15 of the inner needle 14 reaches the blood vessel, the puncture is stopped and the catheter 12 is inserted relative to the inner needle 14. At this time, the user may make the distal end side plate portion 89 of the catheter operation member 70 completely separated from the catheter 12. For example, when the operation unit side separation mechanism 88 is the cutout portion 91, the distal end side plate portion 89 is separated from the proximal end side plate portion 90 (see also FIGS. 5A to 6C). Thereby, the catheter 12 becomes an exposed state, and the user can visually recognize the multi-structure needle 16 well.

Thereafter, the user advances the catheter operating member 70 while grasping the inner needle 14, thereby moving the catheter 12 and the catheter hub 20 relative to the inner needle 14 and the inner needle hub 30 in the distal direction as shown in FIG. 11B. To advance to. The catheter 12 is inserted into the blood vessel smoothly by being supported by the support member 40 when the catheter 12 is advanced.

When the operation plate 71 is generally delivered from the inner needle hub 30, the catheter operation member 70 has the side edge 71 a of the operation plate 71 removed from the operation member groove 43 a of the support member 40, and the hub mounting portion 72 is supported. The support body 42 is rotated by contacting the support body 42 of the member 40. The support main body portion 42 is displaced from the first rotation position shown in FIG. 9A to the second rotation position shown in FIG. 9B to greatly open the front end side of the accommodation space 30a. Thereby, the catheter hub 20, the auxiliary member hub 52, and the needle protection member 60 can pass in the distal direction, and easily come out of the inner needle hub 30.

Although illustration is omitted, when the catheter hub 20 comes out of the inner needle 14, the needle tip 15 of the inner needle 14 is accommodated in the needle protection member 60, thereby exposing the needle tip 15 in the needle protection member 60. To prevent. Further, the user separates the catheter operation member 70 from the catheter 12 and the catheter hub 20 at an appropriate timing, thereby placing the catheter 12 and the catheter hub 20 in the patient.

In addition, the usage method of the catheter assembly 10 which concerns on this embodiment is not limited above. For example, when the blood vessel of the patient is deep, before the multi-structure needle 16 is punctured, the distal end side plate portion 89 of the catheter operation member 70 is separated from the catheter 12 (separation, bending, sliding, etc. are performed in the operation portion side separation mechanism 88). State), the structure may be such that the multi-structure needle 16 is punctured while the support member 40 supports the catheter 12. Even in this case, the support member 40 can suppress the bending of the multi-structure needle 16.

Alternatively, when the blood vessel of the patient is shallow, when the user grasps the support body 80 of the catheter operation member 70 and punctures the multi-structure needle 16, the needle tip 15 of the inner needle 14 immediately reaches the blood vessel. Thereafter, the user can smoothly insert the catheter 12 by releasing the holding of the support 80 and advancing the tab 75 or the like of the catheter operation member 70. At the time of advancement, the catheter operating member 70 is easily separated from the catheter 12 because the distal end portion 78 (the support body 80 returned to the natural state) hits the body surface of the user and is bent, so that the catheter 12 can be smoothly moved. Can be inserted.

As described above, in the catheter assembly 10 according to the first embodiment, the support portion 17 can change the support position in the axial direction of the catheter 12 in the initial state, so that the catheter 12 can be changed according to the condition of the patient. Can be supported appropriately. Thus, when the catheter 12 and the inner needle 14 are punctured into the living body, or when the catheter 12 is inserted into the body, the catheter 12 and the inner needle 14 are prevented from being bent and the extended state is maintained. It can be moved smoothly.

The support portion 17 includes the distal end side support portion 18 and the proximal end side support portion 19 so that the support position in the axial direction of the catheter 12 can be easily changed. In particular, the distal end support portion 18 is provided at the distal end portion 78 of the catheter operation member 70, so that the extension length of the multiple structure needle 16 extending in the distal direction than the distal end side support portion 18 can be shortened. It is possible to suppress the bending of the portion more reliably.

Further, the catheter assembly 10 supports the proximal end side support portion 19 of the inner needle hub 30 in the middle of the catheter 12 in the axial direction, so that the support position is shifted from the distal end side support portion 18 to the proximal end side support portion 19. Even when it changes, the bending of the catheter 12 can be suppressed.

Further, the proximal-side support portion 19 supports the catheter 12 when the catheter 12 is moved, and supports the catheter hub 20 from the inner needle hub 30 by rotating while the catheter operation member 70 is moved. 40. Thereby, the catheter 12 and the catheter hub 20 can be smoothly placed on the patient.

Furthermore, in the catheter assembly 10, the catheter operation member 70 extends from the inner needle hub 30 in the distal direction, and the distal end portion 78 includes the distal end side support portion 18. Therefore, the user can satisfactorily support the catheter 12 extending from the inner needle hub 30 and increasing the degree of freedom through the distal end side support portion 18, and reliably suppress the bending of the multi-structure needle 16. It becomes possible.

And the catheter assembly 10 has the operation part side separation mechanism 88, so that the distal end side support part 18 can be separated from the catheter 12, and the support position by the support part 17 can be changed easily.

Here, the catheter operation member 70 of the catheter assembly 10 according to the first embodiment includes a support body 80 that elastically deforms toward the catheter 12 and contacts the outer peripheral surface of the catheter 12. The support 80 can favorably support the catheter 12 at an appropriate location in the extending direction of the catheter operation member 70 and suppress the bending of the multi-structure needle 16.

In this case, the support body 80 includes the pair of arms 82, so that when the external force by the gripping of the user is applied to the pair of arms 82, the catheter 12 can be clamped satisfactorily. Thereby, the catheter 12 can be firmly supported.

Further, each of the pair of arms 82 has a gripping convex portion 86 protruding outward in the width direction, so that the user can easily support the catheter 12 by guiding the gripping by the user.

[Second Embodiment]
As shown in FIG. 12, the catheter assembly 10 </ b> A (support portion 17 </ b> A) according to the second embodiment includes a pair of side walls 111 of the inner needle hub 110 (housing member) according to the axial length of the catheter operation member 100. It is different from the catheter assembly 10 according to the first embodiment in that it extends and assists the support of the multi-structure needle 16 by the support 103 of the catheter operating member 100 by the pair of side walls 111. 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, as shown in FIG. 13, the distal end portion 102 of the catheter operation member 100 (operation plate portion 101) is provided with a support 103 in which a V-shaped arm 104 is formed symmetrically in a front view. Yes. That is, the pair of arms 104 has a crest 105 on the outer surface side, a trough 106 on the inner surface, and is configured to contact and support the catheter 12 at the trough 106.

Further, the pair of arms 104 is configured to be elastically deformed inward in the width direction and to contact the catheter 12 when the crest portion 105 is pressed against the pair of side walls 111 (wall portions) of the inner needle hub 110. . That is, the pair of arms 104 are shaped so that the holding portions 109 open outward in the width direction in a natural state where they are not subjected to external force by the connecting base portion 108 connected to the base 107. The gap formed between the protruding end portions 109a of the pair of holding portions 109 is naturally larger than the diameter of the catheter 12 and is housed inside the pair of side walls 111 (in a state where an external force is received). ) Is designed to be narrower than the diameter of the catheter 12.

On the other hand, as shown in FIGS. 12 and 13, the side wall 111 of the inner needle hub 110 forms an accommodation space 110 a with the lower wall 31 and the pair of side walls 111 up to the position where the support member 40 is provided. However, there is no lower wall 31 on the tip side of the support member 40 and only the pair of side walls 111 extends. On the side wall 111 on which the support member 40 is provided, a window 112 that allows the support member 40 to rotate is formed.

Also, the pair of side walls 111 has a concave groove 113 on the inner surface side that can partially enter the peak portion 105 of the arm 104 of the catheter operation member 100. The concave groove 113 is formed in a V shape and extends from a position facing the support body 103 to the tips of the pair of side walls 111. The pair of side walls 111 accommodates a part of the mountain portion 105 in the concave groove 113, thereby fixing the arm 104 not only in the width direction but also in the vertical direction, thereby further stabilizing the support of the multi-structure needle 16 by the arm 104. Let

That is, the catheter assembly 10A supports the support of the catheter 12 by the support body 103 of the catheter operation member 100 by the pair of side walls 111, so that the user can perform the puncture of the multi-structure needle 16 or the insertion of the catheter 12. The degree of freedom of the gripping position can be greatly increased. In particular, since the multi-structure needle 16 has a short protrusion length from the support position of the support body 103, the flexure is suppressed well.

The catheter assembly 10A includes an inner needle hub side separation mechanism 114 (accommodating member side separation) that allows the side wall 111 to be separated from the support body 103, in addition to the operation portion side separation mechanism 88 that allows the catheter operation member 100 to be separated. Structure) is provided on the side wall 111 (inner needle hub 110). The operation unit side separation mechanism 88 can adopt the same configuration as that of the first embodiment.

The inner needle hub side separation mechanism 114 is provided, for example, in the vicinity of the place where the support member 40 is installed (the front end side of the window 112), and the side wall 111 (hereinafter referred to as the front end side wall 115) closer to the front end than this portion is the base end side. The side wall 111 (hereinafter referred to as the base end side wall 116) can be deformed.

For example, as shown in FIGS. 14A and 14B, the inner needle hub side separation mechanism 114 can be configured as a slide mechanism portion 117 that retreats the distal end side wall 115 relative to the proximal end side wall 116. As an example, the slide mechanism portion 117 may include a guide portion 117 a that guides the slide to the proximal end side wall 116, and may further include an engaging portion 117 b that prevents the distal end side wall 115 from being detached from the proximal end side wall 116.

Also, for example, as shown in FIGS. 14C and 14D, the inner needle hub side separation mechanism 114 can be configured to have a thin portion 118 at the boundary between the distal end side wall 115 and the proximal end side wall 116. Thereby, the inner needle hub side separation mechanism 114 can fold the distal end side wall 115 along the forming line of the thin portion 118, that is, the thin portion 118 can function as a hinge. When the distal side wall 115 is folded, it is preferable to have a posture maintaining mechanism 119 (for example, a convex portion 119a and a concave portion 119b) that fixes the distal end side wall 115 to the proximal end side wall 116.

14D, the inner needle hub side separation mechanism 114 can also function the thin portion 118 as the cutout portion 120, and may be configured to separate the distal end side wall 115 from the proximal end side wall 116. The cutout part 120 may be configured by a cutout line or the like, similarly to the operation part side separation mechanism 88.

As described above, also in the catheter assembly 10A according to the second embodiment, the support position of the catheter 12 by the support portion 17A can be arbitrarily changed by the user as in the first embodiment. That is, the user can easily change the support position of the catheter 12 by separating the side wall 111 from the support body 103 and separating the catheter operation member 100 from the catheter 12 according to the patient's condition.

In particular, the catheter assembly 10A has side walls 111 (external force applying portions) that apply external force to the pair of arms 104 at opposing positions on the outer side in the width direction of the support body 103, so that the pair of arms 104 can be easily directed to the catheter 12. You can make it.

The catheter assembly 10A has the inner needle hub side separation mechanism 114, so that the side wall 111 can be easily separated from the support body 103. Therefore, it is possible to more easily change the support position by the support portion 17A.

Also, various application examples and modifications can be applied to the catheter assembly 10A according to the second embodiment. For example, the catheter operation member 100 may include a plurality of supports 103 along the longitudinal direction. . Even in this case, an external force can be applied to each support 103 by the side wall 111 of the inner needle hub 110. Further, the catheter assembly 10 </ b> A may be provided with the support body 103 of the catheter operation member 100 at the same position of the support member 40, for example, instead of the support member 40 constituting the proximal end support portion 19. That is, the base end side support part 19 can also be constituted by the support body 103.

Claims

A catheter;
An inner needle removably inserted into the catheter;
A catheter hub for fixedly holding the proximal end of the catheter;
A catheter operating member for moving the catheter and the catheter hub relative to the inner needle,
A support portion for supporting the catheter by contacting the outer peripheral surface of the catheter;
The catheter assembly is characterized in that the support position in the axial direction of the catheter can be changed in an initial state before the catheter moves relative to the inner needle.
The catheter assembly of claim 1.
The support portion includes a distal end side support portion provided at a distal end portion of the catheter operating member, and a proximal end support portion provided closer to the proximal end side than the distal end side support portion. Catheter assembly.
The catheter assembly of claim 2,
In the initial state, comprising a housing member for housing the proximal end side of the catheter,
The catheter assembly, wherein the proximal end support portion is provided on the housing member.
The catheter assembly of claim 3,
The catheter operation member extends in a distal direction from the distal end of the housing member, and has the distal end side support portion in a portion exposed from the housing member.
The catheter assembly according to claim 4.
The catheter operation member has an operation part side separation mechanism for separating the distal end side support part from the catheter.
The catheter assembly of claim 3,
The housing member has a wall portion arranged on the outer side in the width direction of the tip side support portion in the initial state,
The catheter assembly is characterized in that an external force is applied to the wall portion by contacting the outside of the distal end side support portion.
The catheter assembly according to claim 6.
The catheter assembly, wherein the housing member has a housing member side separation mechanism that separates the wall portion from the tip side support portion.
The catheter assembly according to any one of claims 3 to 7,
The proximal end support portion can support the lower side of the catheter in the accommodated state of the accommodating member, and is rotated by being applied with an external force when the catheter operating member is moved, so that the catheter hub is moved from the accommodating member to the catheter hub. A catheter assembly, wherein the catheter assembly is a support member that can be detached.
A catheter;
An inner needle removably inserted into the catheter;
A catheter hub for fixedly holding the proximal end of the catheter;
A catheter operating member for moving the catheter and the catheter hub relative to the inner needle,
The catheter operating member is in a position that is not in contact with the outer peripheral surface of the catheter in a natural state, and has a support body that is elastically deformed toward the catheter when external force is applied and contacts the outer peripheral surface of the catheter. A catheter assembly.
The catheter assembly of claim 9,
The said support body has a pair of arm which can comprise the space which surrounds the outer peripheral surface of the said catheter by front view. The catheter assembly characterized by the above-mentioned.
The catheter assembly according to claim 10.
The pair of arms has a gripping convex portion that protrudes outward of the pair of arms and forms a portion that receives the external force by gripping by a user.
The catheter assembly according to claim 10.
A housing member for housing the proximal end side of the catheter;
The housing member has a wall portion arranged on the outer side in the width direction of the pair of arms,
The said wall part applies the said external force by contacting the outer side of a pair of said arm. The catheter assembly characterized by the above-mentioned.