JPS61100258A - Medical tube and its production - 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) Frontal Technical Field of the Invention The present invention relates to a medical tube and a method for manufacturing the same. Specifically, the present invention relates to medical tubes used in infusion sets, infusion bags, blood transfusion sets, blood bags, blood circuits, continuous ambulatory peritoneal dialysis (CARD) devices, and methods for manufacturing the same.

skin prior art'
If an infusion solution consisting of ff1J, Ami, and electrolytes is stored in an infusion bag in advance, a Maillard reaction may occur during autoclaving and the product may change color. For this reason, it is necessary to aseptically mix the necessary component liquids at the time of use into a previously sterilized infusion bag and administer the mixture to the patient. A closed system is usually employed to aseptically mix such component liquids.

For example, a medical container is used which is equipped with a container liquid guide tube, etc., in which a discharge port, mixed injection port, and bottle needle are attached to the tip and multiple liquid collection tubes are connected via a branch tube. Component liquids are collected and introduced into the container body through a liquid guide tube and mixed. After the liquid collection is completed, the liquid guide tube is tied and hermetically sealed.

On the other hand, medical containers to be incorporated into such a closed system need to transport the liquid to be treated using the difference in gravity and the flexibility of the container material, and are made of flexible synthetic resin. .

Synthetic resin materials with excellent flexibility include soft vinyl chloride resin and ethylene-vinyl acetate copolymer. In this respect, ethylene-vinyl acetate co-ifi combination is preferred.

However, the closed system medical container has a problem in that when the liquid guide tube is tied and sealed after liquid collection, the outer surfaces of the liquid guide tubes are in close contact with each other, making it difficult to tie a knot. Ta. For this reason, there was a drawback that if an attempt was made to forcefully pull the tube to form a knot, the liquid guide tube could break.

(1) Purpose of the Invention Therefore, the purpose of the present invention is to provide a novel medical duplex and a method for manufacturing the same.

An object of the present invention is to provide a medical tube that can extremely easily form a knot to seal a flow path, and a method for manufacturing the same.

These tubes have a fluid flow path inside, and are formed by forming a large number of ribs on the entire outer surface of a flexible synthetic resin tube extending in the axial direction of the tube. A large number of fine protrusions are formed almost uniformly on the tube surface between the ribs, and the height from the concave bottom to the convex top of the cross section of the rib is 0.08 to 0.8 mm. This can be accomplished with medical tubing that can be tied to prevent fluid flow.

Further, in the present invention, the distance between the tops of the cross section of each rib is 0.
It is a medical tube with a diameter of 2 to 0.8 IIIll.

Further, in the present invention, the distance -1 between the protrusions is 5 to 10.
It is a medical duplex having a diameter of 0 μm, preferably 5 to 30 μm. The present invention is a medical tube in which the protrusions have a height of 1 to 10 μl. The present invention also provides a medical duplex in which the flexible synthetic resin is a soft vinyl chloride resin or an ethylene-vinyl acetate copolymer, preferably an ethylene-vinyl acetate copolymer.

In addition, in the manufacturing method of a medical tube having a fluid flow path inside, the temperature of the tip of the die is set 10 to 70'C lower than the temperature of the center of the die, and the temperature is formed on the surface of the tube. By extruding flexible resin through an annular discharge port having grooves corresponding to the shape of the ribs to be
A large number of ribs extending in the axial direction of the tube and having a height of 0.08 to 0.8vn from the concave bottom to the convex top of the cross section are formed on the entire outer surface of the tube, and each rib has a This can also be achieved by a method for manufacturing a medical tube capable of blocking fluid flow by tying, which is characterized by forming a large number of fine protrusions substantially uniformly on the surface of the tube between the tops.

Further, the present invention is a method for manufacturing a medical tube in which the temperature difference between the center of the die and the tip of the die is 30 to 50°C.

(1) Specific structure of the invention Next, one embodiment of the invention will be described with reference to the drawings. That is, as shown in FIGS. 1 to 3, a large number of ribs 3 are formed on the entire outer surface 2 of the flexible synthetic resin duplex 1 and extend in the axial direction of the tube 1. A large number of even finer protrusions 4 are formed almost uniformly on the tube surface between the top of each rib 3 and the top of the adjacent rib 3. For example, by using an electron microscope $1 (magnification: 1,000 times), the shape as shown in the figure can be seen.

In such a duplex 1, the distance ll1lld between the tops of the cross section of each rib is 0.2 to 0.8 mm, preferably 0.3 to 0.511IIIl. Further, the height h from the concave bottom to the convex top is 0.08 to 0.8 mm, preferably 0.1 to 0.6111111. Further, the distance p between the protrusions 4 is 5 to 100 μm, preferably 5 to 30 μm, and the height a is 1 to 10 μm.
m, preferably 2 to 5 μm.

The reason for providing a large number of ribs is that the purpose of the present invention is to easily form a knot and seal the flow path. This is to reduce the contact area between the tube surfaces so that Further, the height from the concave bottom to the convex top of the cross section of the rib needs to be 0.08 to 0.8ml1l. If it is outside this range, the contact area between tube surfaces becomes too large when tying, which is not preferable.

The reason for providing the protrusions is 16. on the tube surface. ,
. The effects of the present invention can be obtained by providing 6□, *')7&94E(1)@ka, 1, and if either of them is missing, the desired effect cannot be obtained. Further, the various numerical limitations described above indicate more preferable ranges for achieving the effects of the present invention, and the ranges are averages of preferable values in consideration of manufacturing errors and the like.

These dimensions can be determined, for example, by so-called universal projectors [e.g.
etor) V-12: Can be measured using a Nikon Co., Ltd. product. The number of ribs is 70 to 9 in the circumferential direction.
It is more preferable to have 5 trees, preferably 60 to 90 trees, in order to achieve the effects of the present invention.

As the flexible synthetic resin constituting the medical tube according to the present invention, soft vinyl chloride resin, ethylene-acid-resistant vinyl copolymer, etc. are preferred, and ethylene-vinyl acetate copolymer is particularly preferred.

Examples of soft vinyl chloride resin include vinyl chloride homopolymer, vinyl acetate, and nylidene chloride.

There are copolymers with comonomers such as acrylonitrile and styrene, and the average degree of polymerization is 700 to 3,000, preferably i,ooo to 2.500, and 30 to 80ff.
iff1%, preferably 40-70! Contains Iia% plasticizer. Examples of the plasticizer include dibutyl phthalate, di-2-ethylhexyl phthalate, diheptyl phthalate, didodecyl phthalate, diethyl octyl adipete, and diethyl octyl separate, with di-2-ethylhexyl phthalate being particularly preferred.

Ethylene-vinyl acetate copolymers have a vinyl acetate content of 3 to 35% by weight, preferably 6 to 3% by weight, and have an average molecular weight of 14. .

OO~25.0001 preferably 2o, oOo~25.
It is 000.

Such a medical tube is obtained by extrusion molding using an extrusion molding machine equipped with a die. Dice 1
0, for example, as shown in FIG. 4, the molten flexible synthetic resin is made up of a die body 11 and a die tip 12, and is extruded from an extrusion molding machine (V shown in the figure) to which the die 10 is connected. The object 13 is extruded through a resin passage 14 of the die body 11 and from an annular outlet 15 formed in the die tip 12 which communicates with the resin passage 14 . The cross-sectional shape of this annular discharge port 15 is almost the same as the cross-sectional shape of the obtained tube, and the outer edge has a rib 3 formed on the outer surface 2 of the tube 1.
Grooves are formed according to the shape of. Therefore, in the present invention, it is necessary to perform extrusion molding by setting the temperature of the die tip 12 to 10 to 70"C lower than the temperature of the die main body 11, which is the center of the die.
It is preferable to set the temperature as low as 0°C. This allows each rib 1
A number of smaller protrusions 4 are formed on the surface between the tops of the
is formed. The reason why fine protrusions are formed on the tube surface under such conditions is that the synthetic resin, which is in a molten state in the die body 11 and has high fluidity, is forced into the low temperature section before being extruded into the air from the discharge port. It is thought that the fluidity deteriorates due to the slow cooling at the die tip 12, which causes fine protrusions (embosses) 4 to be formed. Note that temperature control of each part of the die can be performed electrically or by other methods. For example, when using ethylene-vinyl acetate copolymer as the synthetic resin, the temperature of the die body is 170 to 190"C, but the temperature of the die tip is 170 to 190"C.
The protrusions are formed by extrusion molding at a temperature of 40 to 160'C.

The surface of the tube thus formed can be coated with silicone if necessary.

For example, the coating can be applied by spraying silicone evenly and non-stickly onto the surface of the duplex. The coating does not have to completely uniformly cover the entire surface of the tube, but may instead be dotted with silicone. This makes knot formation easier. The thus obtained medical tube according to the present invention is easy to tie and can thereby easily prevent the flow of fluid, so that it can be used as an infusion set, an infusion bag, a blood transfusion set, or a blood bag.

It can be used in blood circuits, continuous ambulatory peritoneal dialysis (CAPD) devices, etc. - For example, example tGfi5
Figure g shows t, II: Tsuc, ui exit angle -72°!
In a container equipped with a discharge port with a peelable and unsealable seal 22 connected to the inside of the container main body 21 via a mixed injection 025 with a mixed injection logo stopper 24 connected to the inside of the container main body 21 via a mixed injection 023, A liquid collection tube 27 having a bottle needle 26 attached to its tip is connected to the container as a container liquid guiding tube 29 via a branch pipe 28 and used. Note that the reference numeral 30 is a cap of the bottle needle 26.

In such an infusion set, after the cap 30 is removed, each component liquid of the infusion is collected from the bottle bait 26, and the liquid has been collected from the container liquid guide tube 29 into the solution main body 21, this container liquid guide tube 1 - Tie the tubes 29 as shown in FIG. 6 to close the flow path, prevent the flow of liquid, and seal.

Next, the present invention will be explained in detail with reference to Examples.

Example 1 An ethylene-vinyl acetate copolymer having an average molecular weight of about 25,000 (vinyl acetate content 28fflfft%) was
Using the die shown in the figure, a tube with an outer diameter of 7.5 mm and an inner diameter of 5 mm was extruded with the die body temperature set at 180°C and the die tip temperature set at 150°C.
The number of ribs in the axial direction of the qed Chugov is 89, the distance d between the tops of the ribs is 0.3 mm, and the height of the ribs h
is 150μIll, the height a of the protrusion formed on the surface between the tops is 3μtan, and the distance between the protrusions If! to
was 20 μm.

Example 2 The surface of the tube obtained in Example 1 was coated with silicone (dimethyl silicone) to the extent that it did not become sticky.

Comparative Example 1 The same method as in Example 1 was carried out, except that the temperature of both the die body and the die tip were set to 180'C, and a tube having the same rib spacing d and rib height h was obtained. was obtained, but no fine protrusions were formed on the surface between the tops.

Comparative Example 2 The surface of the 1q tube obtained in Example 3 was coated with silicone (dimethyl silicone) to the extent that it did not become sticky.

Test Examples The tubes obtained in Examples 1 and 2 and Comparative Examples 1 and 2 were sterilized with ethylene oxide gas, and the length was 150 cm.
After cutting, I tied a knot and ticked both ends of the tube to the strograph. Total length 100II
When the knot of IIB was pulled for a length of 500 mm at a pulling speed of 200111 m/min and the dimension W of the widest part of the knot was measured as shown in FIG. 6, the graph shown in FIG. 7 was obtained.

Moreover, the fracture rate of the tube at this time was as shown in Table 1.

Example 1 4/20 (20%) Example
2 2/20 (10%) Comparative example 1
14/20 (70%) Comparative example 2 12/
20 (60%) Furthermore, the relationship between the tube tensile length and the tensile force was as shown in FIG. In addition,
In the figure, curve A is Example 1, curve B is Example 2,
The curve C is for the tube of Comparative Example 1, and the curve is for the tube of Comparative Example 2.

(2) Specific Effects of the Invention As described above, the present invention provides a flexible synthetic resin tube with a large number of ribs extending in the axial direction on the entire outer surface of the tube, and the top of each rib. This medical tube is characterized by having a large number of even finer protrusions formed almost uniformly on the surface between the top and the top of the tube. Conventionally, it required a force of about 10 to 15 kg, but when
It is possible to make a single-ply knot that can prevent fluid flow with a knot of about 100 lbs. In addition, while the conventional tube was prone to break during the work of tying a knot in the tube, the tube according to the present invention does not break with this level of force, and the strength has been improved.

In addition, with such a tube, the temperature at the tip of the die is set 10 to 70"C lower than the temperature at the center of the die, and the flexible resin is discharged from the annular outlet having grooves corresponding to the shape of the ribs. Since the molten flexible resin is slowly cooled and extruded into the air, fine protrusions (embosses) are formed on its surface, which also improves the orientation of molecules. is in a constant direction, and mechanical strength such as tensile strength is improved.

Therefore, it is suitable as a medical tube for use in infusion sets, infusion bags, blood transfusion sets, infusion bags, blood circuits, continuous running membrane dialysis (CARD) devices, and the like.

Particularly when using ethylene-vinyl acetate copolymer as a flexible synthetic resin, it was difficult to prevent fluid flow through knots with conventional products, or the tensile strength was insufficient. Medical tubes are highly effective.

[Brief explanation of drawings]

Fig. 1 is a perspective view of a medical duplex according to the present invention, Fig. 2 is an enlarged view of the X section in Fig. 1, Fig. 3 is a sectional view taken along the FIG. 5 is a cross-sectional view, not showing an example of the die used in manufacturing the medical tube according to the present invention, FIG. 5 is a front view showing an example of the use of the medical tube according to the present invention, and FIG.
The figure is a front view showing the knotted state of the medical tube, and FIG. 7 is a graph without showing the size of the knot of the medical duplex.
Further, FIG. 8 is a graph showing the relationship between the tube pulling length and the pulling force. 1...Tube, 2...Outer surface, 3...Rib, 4
...Protrusion, 10...Dice, 11...Dice body, 12...Dice tip, 13...Resin melt, 1
4... Resin passage, 15... Annular discharge port, 20...
Outlet tube, 21... Container body, 27... Liquid collection tube, 28... Branch pipe, 29... Container liquid guide tube. Patent applicant Terumo Corporation No. 11 Figure 2 r-III Figure 4

Claims (9)

[Claims] (1) A flexible synthetic resin tube has a fluid flow path inside, and a large number of ribs are formed on the entire outer surface of the tube, extending in the axial direction of the tube, and the top of each rib is connected to the top of the tube. A knot characterized in that a large number of roughly uniform protrusions are formed on the surface of the tube between the ribs, and the height from the concave bottom to the convex top of the cross section of the rib is 0.08 to 0.8 mm. Medical tubing that can prevent fluid flow. (2) The distance between each top of the cross section of each rib is 0.2 to 0.8
The medical tube according to claim 1, which is mm. (3) The medical tube according to claim 1 or 2, wherein the distance between the protrusions is 5 to 100 μm. (4) The medical tube according to claim 1 or 2, wherein the distance between the protrusions is 5 to 30 μm. (5) The medical tube according to claim 3 or 4, wherein the protrusion has a height of 1 to 10 μm. (6) The medical tube according to any one of claims 1 to 5, wherein the flexible synthetic resin is a soft vinyl chloride resin or an ethylene-vinyl acetate copolymer. (7) The medical tube according to any one of claims 1 to 5, wherein the flexible synthetic resin is an ethylene-vinyl acetate copolymer. (8) In a method for manufacturing a medical tube having a fluid flow path inside, the temperature of the tip of the die is set 10 to 70 degrees Celsius lower than the temperature of the center of the die, so that the ribs formed on the surface of the tube are By extruding flexible resin from an annular discharge port having grooves corresponding to the shape, the height from the concave bottom to the convex top of the cross section is 0 over the entire outer surface of the tube.
．． A large number of ribs having a diameter of 0.8 to 0.8 mm are formed extending in the axial direction of the tube, and a large number of fine protrusions are formed almost uniformly on the tube surface between the tops of each rib. A method for manufacturing a medical tube capable of blocking fluid flow by tying the tube. (9) The temperature difference between the center of the die and the tip of the die is 30 to 5
The method for manufacturing a medical tube according to claim 8, wherein the temperature is 0°C.