JPS59141957A - Stay cathetel and production thereof - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION 1. BACKGROUND TECHNICAL FIELD The present invention relates to an indwelling catheter and a method for manufacturing the same. More specifically, the present invention relates to an indwelling catheter with low penetration resistance and a method for manufacturing an indwelling catheter with excellent workability.

PRIOR ART For example, an intravascular indwelling catheter generally consists of a tube body with openings at both ends into which a catheter for vascular puncture is inserted, and a hub portion fixed to one end of the tube body. It is used by puncturing the blood vessel with the tube inserted, and then pulling out the inside of the tube and leaving the tube roughly pushed into the blood vessel. Therefore, the duplex body of an intravascular indwelling catheter has a certain degree of mechanical strength, can be inserted into a blood vessel, does not easily bend due to external pressure, and can be formed into a tapered tip. In addition, good biocompatibility is required. Generally speaking, in recent years, the wall thickness of this tube body has been made as thin as possible, even if the outer diameter is the same. There is an increasing demand for the ability to use thicker inner needles to strengthen the lower back.

Conventionally, the materials used for the tubes of this type of intravascular catheter are polyethylene and polypropylene.

There are tetrafluoroethylene, fluorinated ethylene-propylene copolymer, ethylene-tetrafluoroethylene copolymer, etc., and the shape of the tip thereof is, for example, as shown in FIG. It consisted of a first taper portion 3 having a relatively large angle α with respect to A-A (right side), and a second taper portion 4 forming a relatively small angle β following the first taper portion 3. This is because the tube material is plastic as mentioned above, so if the tip angle is made smaller, the wall thickness will become smaller as it approaches the tip, and the strength will decrease. The wall thickness is increased by forming the first tapered portion 2 with a relatively large angle α at the end of the catheter tube 1-11.As shown in FIG. The first shift to the right by a relatively large angle Iαα
A mold 5 having a cavity having a shape corresponding to the tapered portion 3 and the second tapered portion 4 that follows the tapered portion 4 and forms a relatively small angle β.
The catheter tube 1 with one core bar 6 inserted therein is inserted, and the tip is pressed to form the catheter tube.

However, in this conventional indwelling catheter, since the angle α of the first tapered portion 3 at the tip with respect to the axis Δ-A is large, the tip portion 2 lacks sharpness, and therefore the penetration resistance value during use is large. There was a drawback. In addition, since such an indwelling catheter is manufactured by pressing a blank plastic tube into the metal mold 5 with the core bar 6, deterioration of the core metal 6 and the mold 5 and It suffers from severe wear and the shape of the tip becomes unstable due to minute changes in processing conditions, which also makes it difficult to make the shape of the tip sharp.

(5) Purpose of the Invention An object of the present invention is to provide an indwelling catheter with low penetration resistance and a method for manufacturing the same.

Another object of the present invention is to provide a method for manufacturing an indwelling catheter with excellent workability.

The purpose of these openings is to provide a second tapered part near the tip of the plastic tube that has a relatively small angle with respect to the axis of the tube, and to form a second tapered part near the tip of the tube, and This is achieved by providing an indwelling catheter with a first tapered portion that continuously curves toward the axis.

Further, in the present invention, the outer diameter of the tube is 0.5-. 3n1m
, an indwelling catheter with an inner diameter of 0.1 to 2.8 mm. Broadly speaking, the present invention is an indwelling catheter in which the plastic is a thermoplastic resin. The present invention also provides an indwelling catheter in which the thermoplastic resin is an ethylene-tetrafluoroethylene copolymer.

The opening purpose is to insert a cored metal into a plastic tube, hold the cored metal at both ends, and rotate the plastic tube around the axis of the cored metal while holding the center part of the cored metal. heating and pulling the tube in opposite directions in the axial direction to form a second tapered section at the heated region having a relatively small angle with respect to the axis of the tube, the minimum diameter of the second tapered section; A heated round rod is pressed around the tube to form a curved groove around the tube, and then the tube is cut at the curved groove to cut the tube from the tip of the second tapered portion to the most distal end of the tube. This is achieved by an FM manufacturing method for an indwelling catheter, which is characterized by providing a first tapered portion that curves continuously toward the axis of the tube.

The present invention also provides an indwelling catheter in which a curved concave groove is formed by pressing a heated round rod to the minimum diameter of the tapered portion in a direction perpendicular to its axis while rotating the tube. It's a method.

The present invention is a method of manufacturing an indwelling catheter in which the tube is cut after the core bar is removed.

In addition, in the present invention, the central part of the duplex is heated by hot air.
An indwelling catheter that has been done! J construction method 7-. Furthermore, the present invention is a method for producing a retention force table in which the heated stone in the center of the tube has a temperature ranging from the softening point of the plastics constituting the tube to 20° C. higher than the softening point.

The present invention is a method for manufacturing an indwelling catheter in which the round rod has a diameter of 0.8 to 8 mm. Further, in the present invention, the outer diameter of the tube is 0.5 to 3n1m, and the inner diameter is 0.1m.
This is a method for manufacturing an indwelling catheter having a diameter of ~2.8 mm.

Further, the present invention is a method of manufacturing an indwelling catheter in which the plastic is a thermoplastic resin. Moreover, the present invention
This is a method for manufacturing an indwelling catheter in which the thermoplastic resin is an ethylenetetrafluoroethylene copolymer.

(8) Detailed Description of the Invention Next, one embodiment of the invention will be described with reference to the drawings. That is, the indwelling catheter according to the present invention has a third
As shown in the figure, a second tapered portion 14 having a relatively small angle β with respect to the axis B-8 of the tube is formed near the tip 12 of the plastic dupe 11, and the second tapered portion 1= 8- A first tapered portion 1 having a curved line 16 that curves from 4 to the distal end portion 15 of the tube 11 toward the axis −B side.
3 are integrally and continuously formed.

- The outer diameter of the tube 11 of the device catheter is 0°5~
3 mm, the inner diameter is 0.1 to 2.8 mm, and the angle β to the axis of the second tapered portion 14 is 1° to 5°.
, preferably 2° to 3°. Further, the angle α of the imaginary line inclination connecting the tip of the second tapered portion 14 and the most distal end of the tube 11 with respect to the axis B-8 is 46 to 76, preferably 46 to 56.

Plastics constituting the indwelling catheter according to the present invention include polyethylene, polypropylene, polydetrafluoroethylene, fluorinated ethylene-propylene copolymer, ethylene-tetrafluoroethylene copolymer, etc., but they do not have an adverse effect on living organisms. Ethylene-detrafluethylene copolymer is most preferable because it allows the wall thickness to be made thinner without compromising mechanical strength.

Such an indwelling catheter according to the present invention is manufactured by the following method. That is, FIG. 4(a) to <e
As shown in >, the core metal 17 was inserted into the plastic tube 11, the core metal 17 was held by a holder (not shown), and the plastic tube 11 was inserted into the core metal 17 at both ends. It is fitted onto the hub 18 and held by a chuck 20 that is separate from the holder (see FIG. 5(a)).

While rotating the plastic tube around the axis of the core metal 17, the central portion of the plastic tube is heated using, for example, a hot air heater 19 (see FIG. 4 (a)). The temperature range is between the softening point of the plastic constituting No. 11 and a temperature 20° C. higher than the softening point Jζ, preferably 5 to 10° C. higher than the softening point.

While performing such heating, or by pulling the plastic tube in the axial direction when the plastic tube is softened by heating, a tapered portion 21 that is inclined toward the axis is formed in the heated region. (see Figure 4 (1) and Figure 5 (l'l)). This forms a second tapered portion 14 having an angle β (see FIG. 3) with respect to the axis.

Next, a heated round bar (for example, a round bar or tube with a built-in heating wire) 23 is pressed around the smallest diameter part 22 of the L-pa part 21 to form a curved groove 23 around the plastic tube 11. (Fig. 4 (C) and Fig. 5 (C))
reference). In this case, the diameter of the round bar 23 is 0.8 to 1.8 m.
m, preferably 1.0 to 1.5 nv. Moreover, the suppression of the round bar 23 against the plastic tube 11 is
Usually, the rotating Chico 111 is pressed from one direction, and a curved groove 24 is formed around it, but the round bar 23 may be rotated while the tube 11 is fixed. Further, similar grooves 24 are formed when both are rotated in opposite directions or in the same direction at different speeds.

Next, after pulling out the core metal 17, the tube 11 is cut by the cutter 25 at the bottom of the curved groove 24 (see Fig. 4 (1) and Fig. 5 (d)).
One end of the distal end 11 of the indwelling catheter according to the present invention as shown in FIG. 4(d) and FIG. 3 is formed. In this case, it goes without saying that even if the core bar 17 is inserted, it can be cut by rotating the cove and/or the cutter.

Note that in the above drawings, the thickness is exaggerated.

As shown in FIG. 6(a), the tube 11 of the indwelling cuff chill with the distal end formed in this manner is attached to the opposite end of the point where it was cut sharply as described above with an adhesive 26. 27 to form an indwelling catheter. In such an indwelling catheter 28, the inner needle 29 is connected to the hub 30.
After the puncture side 31 is dried and used to puncture a blood vessel or other organ, the inner needle 29 is removed and only the indwelling catheter 28 is left in the organ to collect blood and blood.
Other bodily fluids may be drained from the body, or blood,
Return the body fluids or medicinal fluids of the Haku to the human body.

Next, the present invention will be explained in more detail by giving examples.

12-Exception diameter: 1.32mm, inner diameter: 0.96mm, length: 120mm
As shown in FIG. 4(a) and FIG. 5(a), a tube 11 made of ethylene-tetraful A low-edition 1 non-copolymer is inserted with a core bar 17, and then the core bar 17 is held at both ends. The middle part of the tube is heated to 130° C. by the hot air heater 19 while rotating around the axis, and then the tube is pulled from both ends to form a tapered part 21 in the heated part. Figure (11) and Figure 5 (
b)) Next, a tube with a built-in heating wire having a diameter of 1.25 mm was pressed while rotating the tube 11 to form a curved groove 24 (FIGS. 4(c) and 5(0)). . Next, after removing the core metal 17, the cutter 25 cuts the bottom of the curved groove 24 (see FIGS. 4(d) and 5).
An indwelling catheter as shown in Figure (d)) and Figure 3 was obtained. At this time, the angle β was 2° and the angle α was 4.5°.

For comparison, the same material was used to obtain the retention force shown in FIG. 1 by the method shown in FIG. 2 (angle β 8°, angle α 30°).

When the penetration resistance value of the indwelling catheter thus obtained was investigated, the dimensions shown in FIG. 3 were found. The indwelling catheter according to the present invention had a penetration resistance value 20% lower than that of the indwelling catheter shown in FIG. 1. Ta.

The penetration resistance value was determined by stretching a polyethylene film with a thickness of 50 μm over the open end of a cylindrical body with a diameter of 1 Q cm, and then piercing the film surface with the indwelling catheter. (manufactured by Co., Ltd. 4).

■Specific Effects of the Invention As stated above, the indwelling catheter according to the present invention has the following features:
A second tapered portion is provided near the tip of the plastic tube and forms a relatively small angle with respect to the axis of the duplex, and a tapered portion extends from the tip of the second tapered portion to the tip of the duplex.
Since the first taper portion is continuously curved toward the axis, the entire taper portion is relatively short, but because of the first taper portion that curves toward the axis, it is similar to the conventional one. Since the angle α' of the distal end of the indwelling catheter with respect to the axis is extremely small, the shape of the distal end becomes sharp, and damage during penetration is significantly reduced.

Further, in the method for manufacturing an indwelling catheter according to the present invention, a core metal is inserted into a plastic tube, the core metal is held at both ends, and the plastic tube is rotated around the axis of the core metal. - heating the central part of the tube while rotating the tube, and pulling the tube in opposite directions in the axial direction to form a second tapered section having a relatively small angle with respect to the axis of the tube at the heated region; A heated round bar is pressed around the smallest diameter part of the second tapered part to form a curved concave groove around the tube, and then the tube is cut at the curved groove to form the second tapered part. This is done by providing a first tapered part that continuously curves toward the axis of the tube from the tip of the tube to the most distal end of the tube, so there is no need to use an extremely effective mold as in the past. Therefore, there is no wear and tear on the mold (variation or deterioration of the tip shape due to the wear and tear), and a constant quality product can be obtained with an extremely simple process. Therefore, the manufacturing cost is extremely low. Furthermore, since the indwelling catheter manufactured by this method has the above-mentioned tip shape, the tip is sharp and the penetration resistance is significantly reduced.

Therefore, it is extremely useful as an indwelling catheter for blood transfusion, infusion, and dialysis.

Furthermore, while rotating the tube through the curved groove,
If the minimum diameter portion of the tapered portion is formed by pressing a heated round rod in a direction perpendicular to its axis, workability will be significantly improved. Further, when cutting the tube, the core metal is removed and the center of the tube is heated with hot air, which greatly improves work efficiency. Furthermore, if the heating temperature at the center of the tube is within the range of the softening point of the plastics constituting the tube or a temperature 20°C higher than the softening point, when the tube is pulled toward both ends, the desired A taper having an angle of is formed in the heating section. Also, the diameter of the round bar to be pressed is set to 0.8 to 1°811IIIl,
And the outer diameter of the tube is 0.5 to 3 mm, and the inner diameter is 0.1
If the diameter is set to 2.8 mm, a sharp tip shape with extremely low piercing resistance as described above can be obtained.

16- Also, if a thermoplastic resin is used as a plastic, it will be easily deformed by heat, and if an ethylene-tetrafluoroethylene copolymer is used as the thermoplastic resin, the mechanical strength will not be impaired ( It has the advantage of being able to be made extremely thin.

[Brief explanation of drawings]

Fig. 1 is a cross-sectional view showing the tip shape of a conventional indwelling catheter, Fig. 2 is a cross-sectional view showing the relationship between a mold and material showing a conventional method of manufacturing an indwelling catheter, and Fig. 3 is a cross-sectional view showing the shape of the tip of a conventional indwelling catheter. Cross-sectional view showing the tip shape of the catheter, Figure 4 (a)
~(e) are partial cross-sectional side views showing each step of the manufacturing process of the indwelling catheter according to the present invention, and FIGS. 5(a) to (d)
) is an enlarged sectional view of the main part corresponding to FIGS. 4(a) to 4(d), and FIGS. 6(a) to 6(1)) are sectional views showing examples of use of the indwelling catheter. DESCRIPTION OF SYMBOLS 11... Plastic tube, 12... Tip part, 13... First taper part, 14... Second taper part, 16.24... Curved groove, 17... Core metal ,
19... Heater, 21... Taper part, 23...
Round bar, 25...Cutter. Patent applicant Terumo Co., Ltd. 19- Sougou →- -

Claims (13)

[Claims] (1) A second tapered part that has a relatively small angle with respect to the tube axis near the tip of the plastic tube, and a second tapered part that extends continuously from the tip of the second tapered part to the most extreme part of the tube toward the axis. A curved first tapered part is provided (
A powerful indwelling catheter. (2) The outer diameter of the tube is 0.5 to 3 ml, and the inner diameter is 0.1 to 2.8 mm.
Indwelling catheter as described in Section. (3) The indwelling catheter according to claim 1 or 2, wherein the plastic is a thermoplastic resin. (4) The indwelling catheter according to any one of claims 1 to 3, wherein the thermoplastic resin is an ethylene-tetrafluoroethylene copolymer. (5) Insert the core metal into the plastic tube, hold the core metal at both ends, and heat the center part of the plastic tube while rotating it around the axis of the core metal. forming a second tapered portion having a relatively small angle with respect to the axis of the tube in the heated region by pulling the tubes in opposite directions in the axial direction, and
A heated round bar is pressed around the minimum straight part of the tapered part to form a curved groove around the tube, and then the tube is cut at the curved groove to cut the tip of the second tapered part. A method for manufacturing an indwelling catheter, comprising: providing a first tapered portion continuously curved toward the axis of the duplex at the most distal end of the tube. (6) The curved concave groove is formed by pressing a heated round rod against the minimum diameter portion of the tapered portion in a direction perpendicular to its axis while rotating the tube. The method for manufacturing an indwelling catheter described in . (7) The method for manufacturing an indwelling catheter according to claim 5 or 6, wherein the tube is cut after the core metal is removed. (8) The method for manufacturing an indwelling catheter according to any one of claims 5 to 7, wherein the central portion of the tube is heated by moist air. (9) The heating temperature at the center of the tube is
! Claim 5, which ranges from the softening point of the plastic comprising +1 to a temperature 20°C higher than the softening point.
9. A method for manufacturing an indwelling catheter according to any one of Items 8 to 9. (10) The method for manufacturing an indwelling catheter according to any one of claims 5 to 9, wherein the round rod has a diameter of 0.8 to 1.8 mn+r. (11) The indwelling catheter according to any one of claims 5 to 10, wherein the tube has an outer diameter of 0.5 to 3 mm and an inner diameter of 0.1 to 2.8 mm. Production method. (12) The method for manufacturing an indwelling catheter according to any one of claims 5 to 11, wherein the plastic is a thermoplastic resin. (13) Claims 5 to 12, wherein the thermoplastic resin is an ethylene-tetrafluoroethylene copolymer.
A method for manufacturing an indwelling catheter according to any one of paragraphs.