JPH10118189A - Intravenous cannula and intravenous cannula assembly - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an intravenous cannula having an intravenous cannula body which is excellent in failure resistance, kink resistance and front end workability while assuring adequate flexibility. SOLUTION: This intravenous cannula is used to constitute an outside needle inserted into an inside needle and is used at the time of stinging to a living body and has the intravenous cannula body 2 having flexibility. The intravenous cannula body 2 has an inside tube 4 and an outside tube 6 and is constituted by joining these tubes via a reinforcing material layer 5. The reinforcing material layer 5 is constituted by forming wire-shaped bodies 51 preferably consisting of thermoplastic resins to a grid form. These grid-form wire-shaped bodies 51 may be formed by spirally winding one or >=2 pieces of the wire-shaped bodies 51 around the outer periphery of the inside tube 4 in respectively different two directions.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an indwelling needle and an indwelling needle assembly used for indwelling in a blood vessel at the time of, for example, transfusion or blood transfusion.

[0002]

2. Description of the Related Art An indwelling needle assembly composed of an indwelling needle (outer needle) and an inner needle is used for performing infusion or the like on a patient. This indwelling needle assembly has a double needle structure in which an inner needle is inserted into an indwelling needle (outer needle), and punctures an artery or a vein in a state where the indwelling needle and the inner needle are integrated. ,
The inner needle is removed, and only the indwelling needle is left in the living body, and is left.

[0003] The inner needle of the indwelling needle assembly is made of a metal material such as stainless steel, and has a sharp cutting edge (needle tip) formed at its tip. Therefore, when the inner needle is inserted into or removed from the indwelling needle, the indwelling needle may be damaged, cut, broken, broken, peeled, broken, or otherwise damaged by the sharp cutting edge. In particular, it is not preferable that such breakage of the indwelling needle occurs during indwelling in a living body.

For this reason, the indwelling needle is required to have appropriate strength and breakage resistance. Further, the indwelling needle is required to have kink resistance so as not to bend (kink) at a curved portion, a bent portion, or the like of a blood vessel, and is processed into a tip shape so as to be able to puncture a living body advantageously. For this reason, it is necessary to have advanced workability at the time of manufacturing.

However, the indwelling needle, on the other hand, needs to have appropriate flexibility in order to ensure the followability to the curved and bent portions of the blood vessel, and a flexible material is used.
There is a disadvantage that the damage resistance and the kink resistance are inferior.

As described above, since the conventional indwelling needle is made of a single material, it is not possible to simultaneously satisfy the above-mentioned required characteristics.

[0007]

SUMMARY OF THE INVENTION An object of the present invention is to provide an indwelling needle and an indwelling needle assembly which are excellent in breakage resistance, kink resistance and tip workability while securing appropriate flexibility. .

[0008]

This and other objects are achieved by the present invention which is defined below as (1) to (13).

(1) An indwelling needle comprising a tubular indwelling needle body having flexibility, wherein a reinforcing material layer is embedded inside the indwelling needle body.

(2) An indwelling needle comprising an indwelling needle main body having a portion where an inner tube and an outer tube are joined via a reinforcing material layer.

(3) The indwelling needle according to (2), wherein at least one of the inner tube and the outer tube is made of a flexible material.

(4) The indwelling needle according to the above (3), wherein the flexible material is a thermoplastic elastomer.

(5) The indwelling needle according to (4), wherein the thermoplastic elastomer is a polyamide elastomer.

(6) The indwelling needle according to any one of (1) to (5), wherein the reinforcing material layer is formed of a linear body.

(7) The reinforcing material layer is formed by forming a linear body into a spiral shape, a lattice shape, or a linear shape along the longitudinal direction of the indwelling needle main body. The indwelling needle described in Crab.

(8) The indwelling needle according to (6) or (7), wherein the linear body has an inclination angle θ of 0 to 70 ° with respect to an axis of the indwelling needle main body.

(9) The indwelling needle according to any one of the above (6) to (8), wherein the indwelling needle has a portion where the arrangement density of the linear bodies is different.

(10) The indwelling needle according to any one of (6) to (9), wherein the linear body is made of a thermoplastic resin.

(11) The indwelling needle according to any one of the above (6) to (10), wherein the linear body is made of a polyamide resin.

(12) The indwelling needle according to any one of (1) to (11), wherein an area ratio of the reinforcing material layer in a cross section of the indwelling needle main body is 0.1 to 30%.

(13) An indwelling needle assembly comprising the indwelling needle according to any one of (1) to (12) and an inner needle inserted inside the indwelling needle.

[0022]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An indwelling needle and an indwelling needle assembly according to the present invention will be described below in detail with reference to preferred embodiments shown in the accompanying drawings.

FIG. 1 is a plan view showing an example of the configuration of an indwelling needle assembly according to the present invention, and FIG. 2 is a partially cutaway cross-sectional view showing an enlarged view of the configuration near the center of the indwelling needle shown in FIG. is there. In addition, in FIG. 1, the radial direction of the indwelling needle is particularly schematically shown in an enlarged scale for easy understanding.

As shown in FIG. 1, the indwelling needle 1 of the present invention comprises:
The indwelling needle main body 2, the hub 8 attached to the base end 21 of the indwelling needle main body 2, and the caulking pin 7 for caulking the base end 21 of the indwelling needle main body 2 to the hub 8 for mounting. It is configured.

The indwelling needle main body 2 has a lumen 3 formed therein over its entire length. The lumen 3 serves as a flow path for a fluid such as a drug solution. When the indwelling needle 1 is punctured into a blood vessel, an inner needle body 91 of an inner needle 9 described later is inserted into the lumen 3 and integrated with the indwelling needle 1.

The inside of the hub 8 communicates with the proximal end of the lumen 3, and functions as an opening for injecting a liquid such as a drug solution into the lumen 3 and for collecting blood. In addition, hub 8
Functions also as a grip when operating the indwelling needle 1.

The caulking pin 7 is a tubular member made of metal, and has an enlarged diameter portion formed at the base end. By inserting the caulking pin 7, the base end 21 of the indwelling needle main body 2 is crimped (caulked) to the inner peripheral surface on the distal end side of the hub 8 and is firmly fixed.

The inner needle 9 has a sharp cutting edge (needle tip) 92 at the tip.
And a hub 10 attached (fixed) to the base end of the inner needle main body 91. Hub 10 may fit within hub 8 preferably in a fluid-tight manner. Such an inner needle 9 and an indwelling needle 1 constitute an indwelling needle assembly of the present invention.

FIG. 2 shows the internal structure of the indwelling needle main body 2. In FIG. 2, in order to facilitate understanding,
The radial direction of the indwelling needle 1 is particularly enlarged and schematically shown.

As shown in FIG. 2, the indwelling needle main body 2 has an inner tube 4 and an outer tube 6, and these are intermediate layers of a reinforcing material layer 5.
It has a structure joined through the. At least one, and preferably both, of the inner tube 4 and the outer tube 6 are made of a material having flexibility (flexibility).

The constituent materials of the inner tube 4 and the outer tube 6 include
For example, polypropylene, polyethylene, polyolefins such as ethylene-vinyl acetate copolymers, polyamides, polyesters such as polyethylene terephthalate, polybutylene terephthalate, polyurethanes, polyvinyl chloride, polystyrene resins, ethylene-tetrafluoroethylene copolymers, etc. Various thermoplastic elastomers such as a fluorine-based resin, a polyamide elastomer, a polyester elastomer, a polyurethane elastomer, a polystyrene elastomer, and a fluorine-based elastomer, or a combination of two or more thereof can be used.

Among these, thermoplastic elastomers are preferred, and polyamide elastomers are particularly preferred, because they are excellent in antithrombotic properties, moldability, processability, economy and the like.

The polyamide elastomer is, for example, nylon 6, nylon 64, nylon 66, nylon 610, nylon 612, nylon 46, nylon 9, nylon 11, nylon 12, N-alkoxymethyl modified nylon, hexamethylene diamine. -Block copolymers having hard segments of various aliphatic or aromatic polyamides such as isophthalic acid condensed polymers and metaxyloyldiamine-adipic acid condensed polymers, and polymers such as polyester and polyether as soft segments are typical. In addition, polymer alloys (including polymer blends, graft polymerization, random polymerization, etc.) of the polyamide and a resin having high flexibility, those obtained by softening the polyamide with a plasticizer or the like, and further, This is a concept that includes a mixture. The constituent materials of the inner tube 4 and the outer tube 6 may be the same or different.

When the constituent materials of the inner tube 4 and the outer tube 6 are the same or different, the hardness of the material used for the outer tube 6 is preferably about 30 to 80, and preferably about 40 to 70, and about 40 to 70. More preferably, there is. With such hardness, the indwelling needle main body 2 can secure appropriate strength and flexibility, and more excellent breakage resistance and kink resistance can be obtained.

For the same reason, the hardness of the material used for the inner tube 4 is preferably about 30-80, more preferably about 40-70, Shore D hardness.

The thickness of the inner tube 4 and the outer tube 6 is not particularly limited, but the thickness of the inner tube 4 is preferably about 0.02 to 0.10 mm, more preferably about 0.02 to 0.07 mm. The thickness of the outer tube 6 is preferably about 0.02 to 0.10 mm, more preferably about 0.03 to 0.08 mm.

In the configuration shown, the inner and outer diameters of the inner tube 4 and the outer tube 6 are constant, respectively.
These may each partially change along the longitudinal direction of the indwelling needle main body 2. For example, a configuration having a portion in which the inner diameter of the inner tube 4 gradually increases in the distal direction, or a configuration in which the outer diameter of the inner tube 4 or the outer tube 6 at the distal end portion 22 of the indwelling needle body 2 gradually decreases in the distal direction. There may be.

At the boundary between the inner pipe 4 and the outer pipe 6 as described above, a reinforcing material layer 5 is provided. Here, the reinforcing material layer 5
The shape is not particularly limited, and examples thereof include those in which a linear body, a sheet-like body and the like are continuously formed, and those in which pieces are formed in pieces. In particular, those in which a linear body is formed continuously are preferable. The cross-sectional shape of the linear body is not particularly limited, and is preferably a perfect circle, an ellipse (including a band), a triangle, a square, or a star, and a true circular linear body is particularly preferred.

FIGS. 3, 4 and 5 are perspective views each showing an example of the structure of the reinforcing material layer 5. FIG.

The reinforcing material layer 5 is composed of a linear body 51. That is, in the example shown in FIG. 3, the reinforcing material layer 5 is formed by forming the linear members 51 in a lattice shape. This lattice-shaped linear body 51 can be formed by spirally winding one or two or more linear bodies 51 on the outer circumference of the inner tube 4 in two different directions.

In the example shown in FIG. 4, the reinforcing material layer 5 is formed by spirally forming the linear body 51. The spiral linear body 51 can be formed by winding one or two or more linear bodies 51 at a predetermined pitch in one direction around the outer circumference of the inner tube 4.

In the example shown in FIG. 5, the reinforcing material layer 5 has two or more linear bodies 51 formed linearly along the longitudinal direction of the indwelling needle main body 2.

The pattern of the linear body 51 may be a combination of those shown in FIGS. 3 to 5 as appropriate, and may be a pattern other than those shown in FIGS.

The arrangement density of the linear members 51 may be uniform over the entire length of the indwelling needle main body 2 or may have different portions. For example, a part that is intended to increase rigidity (eg:
A portion where the arrangement density of the linear body 51 at the base end 21 is to be increased or flexibility is to be further increased (eg, the tip 2)
The arrangement density of the linear body 51 in 2) can be reduced.

In the arrangement shown in FIGS. 3 and 4, the arrangement density of the linear members 51 is adjusted by the pitch of the spirally wound linear members 51 (the distance between the adjacent linear members 51). ),
The adjustment can be performed by adjusting at least one condition of the number and the inclination angle θ described later. In the configuration illustrated in FIG. 5, the adjustment can be performed by changing the number of the linear bodies 51 arranged.

The reinforcing material layer 5 is not limited to the case where the reinforcing material layer 5 is provided over the entire length of the indwelling needle main body 2. The indwelling needle main body 2 has a portion where the reinforcing material layer 5 is not provided. You may. For example, a configuration in which the reinforcing material layer 5 is provided in a portion of the indwelling needle main body 2 except for the distal end portion 22, or a configuration in which the indwelling needle main body 2 is provided.
The reinforcing material layer 5 can be arranged in a portion other than the base end portion 21 of FIG.

The constituent material of the linear body 51 forming the reinforcing material layer 5 has such a rigidity that the indwelling needle main body 2 has sufficient damage resistance (particularly cut resistance) and kink resistance. Any material may be used as long as it is a thermoplastic resin. As the thermoplastic resin, when forming the distal end portion 22 of the indwelling needle main body 2 into a desired shape (for example, a tapered shape as shown in FIG. 1), the heat can be melted or softened by the heating. Those having plasticity are preferred.

Examples of such a material include polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), polyolefins such as polyethylene and polypropylene, rigid polyvinyl chloride, polyamide, polyimide, polyamideimide, and polystyrene. , Thermoplastic polyurethane, polycarbonate, ABS resin, AS resin, acrylic resin, polymethyl methacrylate (PMMA), polyacetal (P
A), polyarylate, polyoxymethylene (PO
M), high tensile strength polyvinyl alcohol, fluororesin, polyvinylidene fluoride (PVdF), polytetrafluoroethylene, ethylene-vinyl acetate saponified (EVOH),
Polysulfone, polyether sulfone, polyether ketone, polyether ether ketone, polyphenylene oxide, polyphenylene sulfide, liquid crystal polymer,
Or a polymer alloy comprising any of these,
Alternatively, a combination of two or more of these may be mentioned. Among them, a polyamide or a polyamide-based resin mainly containing polyamide is particularly preferable.

Here, polyamide refers to, for example, nylon 6, nylon 64, nylon 66, nylon 610,
Nylon 612, Nylon 46, Nylon 9, Nylon 11, Nylon 12, N-alkoxymethyl modified nylon, hexamethylenediamine-isophthalic acid condensation polymer,
Representative examples include various aliphatic or aromatic polyamides such as metaxyloyldiamine-adipic acid condensate, and polymer alloys of the polyamide and other resins (polymer blend, graft polymerization, random polymerization, etc.), Furthermore, the concept includes these mixtures.

The linear body 51 may be a single fiber or an aggregate of fibers (for example, a single fiber twisted) made of the above-described materials or the like. Is more preferable in that a single fiber is used.

The thickness (diameter) of the linear body 51 is appropriately determined in relation to the constituent materials. That is, a necessary and sufficient reinforcing effect and flexibility can be obtained for the indwelling needle main body 2, and the workability of the distal end processing of the distal end portion 22 is set to a satisfactory degree. For example, when the linear body 51 is made of a single polyamide fiber, its diameter is preferably about 20 to 50 μm. In addition, the linear body 51 may be used singly or may be used in a state where a plurality of bundles are bundled.

As described above, the distal end portion 2 of the indwelling needle body 2
2 may be processed into a tapered shape by heat treatment, or may be processed in advance into a trumpet shape by heat treatment to fit the caulking pin 7 on the base end portion 21 of the indwelling needle main body 2.
At this time, it is preferable that the linear body 51 (the constituent material of the reinforcing material layer 5) is melted or softened.

Accordingly, the melting temperature (melting point) of the linear body 51 (constituting material of the reinforcing material layer 5) is T ₁ , and the melting temperatures of the inner pipe 4 and the outer pipe 6 (the average value when both are different) are When T ₂ , T ₁ −T ₂ is preferably 60 ° C. or lower, more preferably 30 ° C. or lower, and further preferably T ₁ ≦ T ₂ . When such a relationship is satisfied, more excellent workability can be obtained in the above-described processing.

When T ₁ is sufficiently lower than T ₂ , when the linear body 51 is continuously wound around the outer peripheral surface of the inner tube 4 in the manufacturing process of the indwelling needle body 2, May melt or soften. In this case, the reinforcing material layer 5 is composed of the linear body 51 in a molten or softened state. The melted linear body 51 generates an adhesive force with the inner tube 4 or the outer tube 6, and the linear body 5
1 is less likely to come off, and the effect of reinforcing the indwelling needle main body 2 is enhanced.

The inclination angle θ of the linear body 51 with respect to the axis of the indwelling needle main body 2 (hereinafter, simply referred to as “inclination angle”) is 0 to 7
It is preferably 0 °, more preferably 15-60 °. Here, θ = 0 ° indicates a state shown in FIG. 5 (a state in which the linear body 51 is arranged parallel to the axis of the indwelling needle main body 2). When the inclination angle θ is within this range, the indwelling needle main body 2 exhibits more excellent kink resistance and followability.

It should be noted that the inclination angle θ may be the same over the entire length of the reinforcing material layer 5 or may have portions having different inclination angles θ along the longitudinal direction of the indwelling needle main body 2.

The reinforcing material layer 5 as described above, especially the linear body 51
The area ratio of the reinforcing material layer 5 in the cross section of the indwelling needle body 2 is 0.1 to 30%
Is preferably about 0.5 to 25%, more preferably about 3 to 20%. If the area ratio is too low, the reinforcing effect becomes insufficient depending on the constituent materials of the reinforcing material layer 5 and the constituent materials of the inner pipe 4 and the outer pipe 6, and if the area ratio is too high, the reinforcing material layer 5 In some cases, the bending rigidity of the indwelling needle main body 2 may be too large, and the flexibility may be insufficient, depending on the constituent materials of the inner tube 4 and the outer tube 6.

As described above, in the indwelling needle 1 according to the present invention, the indwelling needle main body 2 has the reinforcing material layer 5, particularly the reinforcing material layer 5 of the linear body 51, so that the indwelling needle main body 2 has an appropriate flexibility. Demonstration of excellent breakage resistance (resistance to breakage such as scratching, scraping, cracking, chipping, breaking, peeling, cutting, breakage, etc.) and kink resistance while securing the properties, and the structure of the reinforcing material layer 5 By selecting the material, excellent tip workability in processing the tip portion 22 is exhibited.

It should be noted that the indwelling needle of the present invention differs from the configuration shown in the drawing in that there is no or unclear boundary (discrimination) between the inner tube 4 and the outer tube 6, and a portion corresponding to the inner tube 4 and the outer tube For example, a part corresponding to the part 6 may be integrated.

Next, a preferred example of a method for manufacturing the indwelling needle 1 will be described. First, the inner tube 4 is manufactured according to a standard method. The inner tube 4 can be manufactured by, for example, extrusion molding.

Next, the linear body 51 is spirally wound around the outer peripheral surface of the inner tube 4. This winding can be performed using, for example, a device (not shown) called a spiral machine. The linear body 51 is fed out from the linear body supply section of the spiral machine, while the inner pipe 4 is moved in the axial direction with respect to the linear body supply section and rotated about the axis to rotate the inner pipe 4.
The linear body 51 is continuously wound around the outer peripheral surface of.

After reaching the end of the inner tube 4, the moving direction of the inner tube 4 is reversed without changing the rotation direction of the inner tube 4, or the inner tube 4 returns to the starting end to change the moving direction of the inner tube 4. If the same direction is set and the rotation direction of the inner tube 4 is set to the opposite direction, a lattice-shaped linear body 51 as shown in FIG. 3 can be formed.

In the above description, the moving method is such that the inner pipe 4 rotates and moves in the axial direction. However, the present invention is not limited to this, and the inner pipe 4 and the linear body supply unit rotate relatively, and It is only necessary to relatively move in the axial direction of the inner pipe.
Rotate, the linear body supply part moves in the axial direction of the inner pipe, the inner pipe 4 moves in the axial direction, and the linear body supply part rotates around the outer circumference of the inner pipe. A method in which the linear body supply unit is fixed around and rotates in the axial direction of the inner pipe while rotating around the outer circumference of the inner pipe 4 or a method in which these are appropriately combined may be used.

When the reinforcing material layer 5 is formed on the outer peripheral surface of the inner tube 4 as described above, the outer periphery is covered with the outer tube 6. The outer tube 6 is joined such that the inner peripheral surface of the outer tube 6 is in close contact with the outer peripheral surface of the inner tube 4 and the linear body 51.

As the method, for example, (a) the outer tube 6
(B) inner tube 4
(Eg, thermal fusion, high-frequency fusion)
(C) a method of heating or swelling the outer tube 6 using a solvent, inserting the inner tube 4 into the outer tube 6, and then contracting the outer tube 6, (d) a method of melting or liquefying the outer tube 6 A method of forming the outer tube 6 by applying a tube forming material to the outer peripheral surface of the inner tube 4 or the like by dipping, coating, or the like, and solidifying by cooling or drying (desolvation treatment).

The laminate of the inner tube 4, the reinforcing material layer 5, and the outer tube 6 thus obtained is cut into predetermined pieces,
If necessary, the above-described processing of the distal end portion 22 and the base end portion 21 is performed. Thereby, the indwelling needle main body 2 is completed.

The indwelling needle 1 is completed by fitting the caulking pin 7 into the base end portion 21 of the indwelling needle main body 2 thus obtained and further attaching the hub 8.

It goes without saying that the configuration and the manufacturing method of the indwelling needle 1 of the present invention are not limited to those described above. In particular, the configuration of each part of the indwelling needle 1 can be replaced with any configuration that can similarly function.

The indwelling needle main body of the indwelling needle 1 of the present invention comprises, besides the inner tube 4, the reinforcing material layer 5, and the outer tube 6, other layers such as a coating layer and an intermediate layer formed for any purpose. May be provided. For example, a protective layer, an antithrombotic layer, a lubricating layer, a wear-resistant layer, and the like may be formed on the inner peripheral surface of the inner tube 4 and the outer peripheral surface of the outer tube 6, or an arbitrary layer may be provided between the inner tube 4 and the outer tube 6. An intermediate layer such as an adhesive layer can be provided at the location.

[0070]

EXAMPLES Hereinafter, specific examples of the indwelling needle of the present invention will be described.

Example 1 An indwelling needle having the structure shown in FIGS. 1, 2 and 3 was manufactured by the method described above. The conditions of each part are as follows.

The reinforcing material layer 5 was manufactured by using a spiral machine and moving the inner tube 4 in the axial direction and rotating it with respect to the linear body supply portion (fixed).

The tapering of the tip 22 (tip processing) was performed by pushing the end of the indwelling needle body 2 into a mold (mold temperature: 220 ° C.).

The inner tube 4 is formed by extrusion molding, and the outer tube 6 is formed by extrusion coating the molten outer tube forming material on the outer peripheral surface of the inner tube 4 on which the reinforcing material layer 5 is formed. And then cooled and solidified.

The total length of the indwelling needle body: 32 mm The outer diameter of the outer tube 6: 0.86 mm The outer diameter of the inner tube 4: 0.75 mm The inner diameter of the inner tube 4: 0.64 mm The constituent material of the outer tube 6: polyether-fragrance Group polyamide copolymer (PEO-NyM12) (melting point T ₂ : 185 ° C.,
Shore D hardness: 55)

Material of the inner tube 4: Same as the outer tube 6 Structure of the reinforcing material layer 5: The linear body 51 is formed in a lattice shape (the state shown in FIG. 3) Forming area of the reinforcing material layer 5: indwelling needle main body 2 Almost full length Constituent material of linear body 51: Single fiber of polyamide (nylon 6, melting point T ₁ : 210 ° C.)

Diameter of linear body 51: 41 μm Inclination angle θ: 45 ° Number of linear bodies 51: 24 Area ratio of reinforcing material layer 5 in cross section of indwelling needle body 2: 17.3%

(Example 2) An indwelling needle similar to that of Example 1 was manufactured except that the number of the linear members 51 constituting the reinforcing material layer 5 was 36. The area ratio of the reinforcing material layer 5 in the cross section of the indwelling needle main body 2 was 25.9%.

(Example 3) Except that the number of the linear members 51 constituting the reinforcing material layer 5 is one and this is spirally wound at an inclination angle θ = 15 ° (state shown in FIG. 4). Manufactured the same indwelling needle as in Example 1. The area ratio of the reinforcing material layer 5 in the cross section of the indwelling needle main body 2 is 0.5
%Met.

(Example 4) Except that the number of the linear members 51 constituting the reinforcing material layer 5 is six and this is spirally wound at an inclination angle θ of 15 ° (the state shown in FIG. 4). Manufactured the same indwelling needle as in Example 1. The area ratio of the reinforcing material layer 5 in the cross section of the indwelling needle main body 2 is 3.2.
%Met.

(Embodiment 5) At the distal end portion 22 of the indwelling needle main body 2, the inclination angle θ of the linear body 51 is set to 65 ° and the spiral pitch is reduced, so that the arrangement of the linear body 51 at the distal end portion 22 is reduced. An indwelling needle similar to that of Example 1 was manufactured except that the installation density was higher than other portions. The indwelling needle body 2
The area ratio (average value of the distal end portion 22 and other portions) occupied by the reinforcing material layer 5 in the cross section was 28.9%.

(Embodiment 6) At the distal end portion 22 of the indwelling needle main body 2, the inclination angle θ of the linear body 51 is set to 60 °, and the pitch of the spiral is reduced. An indwelling needle similar to that of Example 4 was manufactured except that the installation density was higher than the other parts. The indwelling needle body 2
The area ratio occupied by the reinforcing material layer 5 in the cross section (average value of the tip portion 22 and other portions) was 6.1%.

(Example 7) As the reinforcing material layer 5, a total of 36
Example 1 except that the linear bodies 51 were arranged on the outer peripheral surface of the inner tube 4 at equal intervals in parallel along the longitudinal direction of the indwelling needle main body 2 (the state shown in FIG. 5, the inclination angle θ = 0 °). The same indwelling needle as in Example 1 was produced. The area ratio of the reinforcing material layer 5 in the cross section of the indwelling needle main body 2 was 18.3%.

(Comparative Example) Except that the reinforcing material layer 5 was not provided,
An indwelling needle similar to that in Example 1 was manufactured.

For each of the indwelling needles of Examples 1 to 7 and Comparative Example, the kink resistance, breakage resistance and tip workability of the indwelling needle main body 2 were measured by the following methods. The measurement results are shown in Table 1 below.

<Measurement of Kink Resistance> The indwelling needle main body 2 was repeatedly bent at 90 ° with a radius of curvature of 5 mm 50 times, and it was examined whether or not the indwelling needle main body 2 was broken (kink) at that time. The results are shown in Table 1 below. The measurement was performed on 20 indwelling needle bodies.

<Measurement of Breakage Resistance> The indwelling needle body 2 was pulled straight in the axial direction at a speed of 300 mm / min to break it, and the load (tensile strength) at break was measured. The results are shown in Table 1 below. The measurement was performed at room temperature (20 ° C.) and at a constant temperature (37 ° C.) for 20 indwelling needle bodies, respectively.
° C (near body temperature)) and the average value was determined.

<Evaluation of tip end workability> Ease of processing at the end end end was evaluated in three stages of A, B and C in descending order of ease.

[0089]

[Table 1]

As shown in Table 1, Examples 1 to 7
All of the indwelling needles have excellent kink resistance, breakage resistance and tip workability of the indwelling needle body. On the other hand, the indwelling needle of the comparative example does not have a reinforcing material layer, and therefore has poor kink resistance and breakage resistance.

[0091]

As described above, according to the indwelling needle and the indwelling needle assembly of the present invention, sufficient strength can be obtained by providing the reinforcing material layer on the indwelling needle main body. As a result, the indwelling needle can be obtained. The breakage resistance and the kink resistance can be improved while securing appropriate flexibility in the main body.

In particular, when the reinforcing material layer is formed of a linear body, the flexibility and the reinforcing effect of the indwelling needle main body can be easily adjusted appropriately depending on the conditions such as the arrangement density, and the inclination angle of the linear body Is set in a desired range, more excellent kink resistance and followability can be obtained with the indwelling needle body. Also,
The same applies when the area ratio of the reinforcing material layer in the cross section of the indwelling needle main body is set to a desired range.

When the linear body is made of a thermoplastic resin such as a polyamide resin, the linear body is melted or softened during the thermal processing of the distal end portion of the indwelling needle main body, and the linear body is melted or softened during the distal processing. Workability is improved. Such improvement in workability of the tip processing also contributes to prevention of breakage of the indwelling needle main body.

[Brief description of the drawings]

FIG. 1 is a plan view showing a configuration example of an indwelling needle assembly according to the present invention.

FIG. 2 is a partially cutaway sectional view showing the internal structure of the indwelling needle main body of the indwelling needle shown in FIG.

FIG. 3 is a perspective view showing a configuration of a reinforcing material layer in an indwelling needle main body of the indwelling needle shown in FIG.

FIG. 4 is a perspective view showing another configuration example of the reinforcing material layer in the present invention.

FIG. 5 is a perspective view showing another configuration example of the reinforcing material layer in the present invention.

[Explanation of symbols]

 REFERENCE SIGNS LIST 1 indwelling needle 2 indwelling needle main body 21 proximal end 22 distal end 3 lumen 4 inner tube 5 reinforcing material layer 51 linear body 6 outer tube 7 caulking pin 8 hub 9 inner needle 91 inner needle body 92 cutting edge (needle tip) 10 Hub

Claims (13)

[Claims] 1. An indwelling needle comprising a tubular indwelling needle main body having flexibility, wherein a reinforcing material layer is embedded inside the indwelling needle main body. 2. An indwelling needle comprising an indwelling needle main body having a portion in which an inner tube and an outer tube are joined via a reinforcing material layer. 3. The indwelling needle according to claim 2, wherein at least one of the inner tube and the outer tube is made of a flexible material. 4. The indwelling needle according to claim 3, wherein the material having flexibility is a thermoplastic elastomer. 5. The indwelling needle according to claim 4, wherein the thermoplastic elastomer is a polyamide elastomer. 6. The indwelling needle according to claim 1, wherein the reinforcing material layer is formed of a linear body. 7. The reinforcing material layer according to claim 1, wherein the reinforcing material layer is formed by forming a linear body into a spiral shape, a lattice shape, or a linear shape along a longitudinal direction of the indwelling needle main body. Indwelling needle. 8. The indwelling needle according to claim 6, wherein the linear body has an inclination angle θ of 0 to 70 ° with respect to an axis of the indwelling needle main body. 9. The indwelling needle according to claim 6, wherein the indwelling needle has a portion having a different arrangement density of the linear bodies. 10. The indwelling needle according to claim 6, wherein the linear body is made of a thermoplastic resin. 11. The indwelling needle according to claim 6, wherein the linear body is made of a polyamide resin. 12. The indwelling needle according to claim 1, wherein an area ratio of the reinforcing material layer in a cross section of the indwelling needle main body is 0.1 to 30%. 13. An indwelling needle assembly comprising the indwelling needle according to any one of claims 1 to 12 and an inner needle inserted inside the indwelling needle.