JP2004187817A - Infusion tube - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide an infusion tube which enables an accurate control of the flow rate of an infusion in a method of delivering a fluid by a pump, is appropriate to use in an infusion injection line, and is made of non-polyvinyl chloride. <P>SOLUTION: The infusion tube is formed by molding a resin composition made of a styrene-isoprene-styrene triblock copolymer mixed in 1,2-polybutadiene. (1)The amount of the mixed copolymer based on the total amount of the resin composition is 5-50 percent by weight. (2) The copolymer contains 5-50 percent by weight of the styrene unit, and 3,4-vinyl bond equal to or less than 20 percent in the isoprene block. (3) The infusion tube shows 50-78 in Shore A hardness. <P>COPYRIGHT: (C)2004,JPO&NCIPI

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to an infusion tube, and more particularly, to an infusion tube that can be suitably used in an infusion infusion line in which a tube is mounted on an infusion pump to feed an infusion.
[0002]
[Prior art]
An infusion system that feeds nutrients, drug solutions, blood, and other liquids into the body generally includes an infusion bottle or infusion bag that is a storage tank for nutrients and the like, and an infusion catheter that enters the body and sends it to a target location. And an infusion line as a transfer circuit therebetween or a liquid injection site. As a method of transferring a liquid in an infusion line, there are a spontaneous dropping method and a pumping method. In the spontaneous dropping method, the infusion tube constituting the infusion infusion line is pressed with a roller clamp to control the infusion flow rate. In the pump infusion method, the infusion tube is inserted into an infusion pump having a drive mechanism that intermittently pushes down the tube. , And adjusting the driving speed of the pump to feed the liquid at a desired constant flow rate. In general, when it is necessary to control the infusion flow rate accurately, a pump liquid feeding method is used because it is difficult with the natural dropping method.
[0003]
For the infusion tube as a transfer circuit, the infusion tube is pressed or pressed down in order to facilitate handling such as laying of the tube, and in both the case of the spontaneous dropping method and the pumping method. Needs flexibility.
Further, the infusion tube is required to be transparent so that the presence of the contents can be confirmed.
Conventionally, a tube made of a soft vinyl chloride resin has been used as an infusion tube having such flexibility and transparency. However, infusion tubes made of soft vinyl chloride resin may cause the plasticizer to elute and adversely affect the human body, or the drug may be adsorbed on the inner surface of the tube and reduce the efficacy, or chlorine-containing waste However, there is a problem such as incineration, and conversion to other materials has been desired.
[0004]
In recent years, the use of 1,2-polybutadiene which is excellent in transparency and does not adsorb drugs has been studied as a material for medical tubes such as infusion tubes instead of soft vinyl chloride resin. It is a resin having poor flexibility, and if a plasticizer is used to improve this, the problem of elution also occurs.
In order to solve such a problem, it has been proposed to add flexibility to a tube made of 1,2-polybutadiene by adding an elastomeric material to 1,2-polybutadiene instead of a plasticizer (Patent Document 1). Reference 1).
However, since this tube is mainly used for catheters such as urinary catheters, the addition of a specific elastomeric material causes the tube to bend so that it does not bend and block the flow path when inserted into the body (flexibility). Is given. In this case, the rebound resilience inherent in 1,2-polybutadiene (expressed by a loss tangent in dynamic viscoelasticity measurement in longitudinal vibration) is reduced. When an infusion injection line is constructed using such a tube and attached to an infusion pump having a drive mechanism for intermittently pressing the tube, and the liquid is sent, the shape recovery property after the tube is pressed is improved. Due to the inferiority, stable liquid sending cannot be performed. In particular, in order to perform stable infusion at a relatively high flow rate using such an infusion pump, the tube of the infusion infusion line must be quickly restored to its original shape after being squeezed.
[0005]
[Patent Document 1]
JP-A-2002-11092
[Problems to be solved by the invention]
An object of the present invention is to provide an infusion tube made of a non-polyvinyl chloride material, which can control an infusion flow rate accurately in a pumping system and can be suitably used in an infusion infusion line.
[0007]
[Means for Solving the Problems]
The present inventor has conducted various studies to achieve the above object, and as a result, 1,2-polybutadiene has a styrene unit amount of 5 to 50% by weight and a 3,4-vinyl bond of an isoprene block portion. A tube is formed from a material in which a styrene-isoprene-styrene triblock copolymer having a proportion of 20% or less is blended in an amount of 5 to 50% by weight based on the total amount of the resin composition, and a specific hardness is secured. A 1,2-polybutadiene-based infusion preferably used for an infusion infusion line, which is provided with necessary flexibility while maintaining rebound resilience required for controlling an infusion flow rate accurately in a pumping system. The present inventors have found that a tube for use can be obtained, and have completed the present invention based on this finding.
[0008]
Thus, according to the present invention, a resin composition comprising a 1,2-polybutadiene and a styrene-isoprene-styrene triblock copolymer is molded, and (1) the resin composition based on the total amount of the resin composition is obtained. (2) The copolymer has a styrene unit amount of 5 to 50% by weight and a proportion of 3,4-vinyl bonds in an isoprene block portion. Is not more than 20%, and (3) an infusion tube having a Shore A hardness of 50 to 78 is provided.
It is preferable that the above-mentioned infusion tube has a loss tangent at 25 ° C. of less than 0.15 in dynamic viscoelasticity measurement by longitudinal vibration.
[0009]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, the present invention will be described in detail.
The 1,2-polybutadiene (hereinafter sometimes referred to as 1,2-PB) used in the present invention is, for example, a specific vanadium compound and an organic aluminum compound, a chromium compound and an organic aluminum compound, a titanium compound and an organic aluminum compound. A crystalline polymer obtained by solution polymerization or emulsion polymerization of butadiene using an organic ester of molybdic acid, Co (CO) ₈ MoCl ₅ , palladium chloride or the like as a catalyst (for example, JP-A-5-222203, JP-A-7-224117, JP-A-2001-181335, etc.). The content of 1,2-bonds in the polymer chain (morelo method by infrared spectroscopy) is preferably at least 70 mol%, more preferably at least 85 mol%. This 1,2-bond may be either syndiotactic or isotactic. The crystallinity is preferably 5 to 50% by weight, more preferably 10 to 40% by weight. Such 1,2-polybutadiene is commercially available and can be obtained under the trade name JSR RB (manufactured by JSR Corporation).
[0010]
The styrene-isoprene-styrene triblock copolymer (hereinafter sometimes referred to as SIS) used in the present invention has a styrene unit amount of 5 to 50% by weight and a 3,4- It is necessary that the ratio of the vinyl bond is 20% or less, the styrene unit amount is 10 to 30% by weight, and the amount of the 3,4-vinyl bond in the isoprene block portion is more preferably 10% or less.
If the styrene unit amount is more than 50% by weight, the desired flexibility cannot be imparted to 1,2-PB. Insufficient stiffness makes handling difficult.
If the proportion of the 3,4-vinyl bond in the isoprene block is 20% or more, the SIS tends to have more resinous properties, and the compatibility with 1,2-PB tends to be poor. , The rebound resilience is lower than that of 1,2-PB. When such a resin composition is used as an infusion tube, the shape recovery force is poor, and it is difficult to accurately control the infusion flow rate in a pumping method.
[0011]
The SIS used in the present invention may be prepared by block copolymerizing styrene and isoprene according to a known polymerization method. For example, using an organic monolithium polymerization initiator such as n-butyllithium, a chain hydrocarbon solvent, a cyclic hydrocarbon solvent or a mixture thereof which is inert to the polymerization initiator such as n-butane, n-hexane and cyclohexane. It is polymerized in a solvent. It can be obtained by successively block copolymerizing styrene and isoprene, or by coupling a styrene-isoprene diblock copolymer having an isoprene polymerization active terminal obtained by block copolymerizing styrene with isoprene.
In order to reduce the proportion of 3,4-vinyl bonds in the isoprene block portion of the SIS used in the present invention to 20% or less, a polar compound of 0.01 to 0.1 mol per 1 mol of the polymerization initiator. The method of polymerizing in the presence of is recommended.
[0012]
As the polar compound, an aromatic ether, an aliphatic ether or a tertiary amine having a relative dielectric constant of 2.5 to 5.0 measured at 25 ° C. is preferable. Specific examples of such a polar compound include aromatic ethers such as diphenyl ether and anisole; aliphatic ethers such as diethyl ether and dibutyl ether; tertiary monoamines such as trimethylamine, triethylamine and tripropylamine; tetramethylethylenediamine; Tertiary polyamines such as tetraethylethylenediamine are exemplified.
[0013]
Such a styrene-isoprene-styrene triblock copolymer is commercially available, and can be obtained, for example, under the trade names JSR SIS (manufactured by JSR), Quintac (manufactured by Zeon Corporation), and the like.
[0014]
The infusion tube of the present invention is obtained by molding a resin composition obtained by mixing the above styrene-isoprene-styrene triblock copolymer with 1,2-PB, and the total amount of the resin composition. Is 5 to 50% by weight, more preferably 10 to 25% by weight. If the blending amount of the copolymer is more than 50% by weight, the stiffness of the tube becomes insufficient and handling becomes difficult. If the amount is less than 5% by weight, desired flexibility cannot be imparted to the tube.
[0015]
In producing the infusion tube, the resin composition may be a uniform composition in which 1,2-PB is kneaded with a predetermined amount of the styrene-isoprene-styrene triblock copolymer by any means. preferable. At the time of kneading, an antioxidant, a cross-linking agent, an ultraviolet absorber and the like can be appropriately used, if necessary. However, these additives as well as those which do not affect hygiene should be selected.
The use of a fatty acid amide compound as an additive is preferable because the moldability can be improved and the flexibility of the obtained tube can be improved. As the fatty acid amide compound, primary acid amides and bisamides of saturated or unsaturated higher fatty acids having 7 or more carbon atoms are preferable. For example, stearic acid amide, oleic acid amide, palmitic acid amide, coconut oil fatty acid amide, N, N'-methylenebis- (stearamide), N, N'-ethylenebis- (stearamide) and the like can be mentioned. Among these, unsaturated fatty acid amide compounds are preferable, and oleic acid amide is particularly preferable. The fatty acid amide compound is preferably used in an amount of 0.05 to 5 parts by weight per 100 parts by weight of 1,2-PB.
[0016]
From the resin composition, an infusion tube having a desired inner diameter and wall thickness can be produced by a usual molding method such as extrusion molding. Further, according to the single-screw or twin-screw extruder, the kneading operation can be performed in the molding machine.
[0017]
If necessary, the strength of the molded tube can be improved by cross-linking the surface of the tube by irradiation with ionizing radiation such as ultraviolet rays or electron beams, or by plasma treatment. In particular, when the low-temperature plasma treatment is performed, the strength of the tube is improved and the flexibility is improved.
Glow discharge, which is generally used as a low-temperature plasma treatment, generates a plasma state by performing discharge in a low-pressure gas of usually 10 ^{−2 to} 10 mmHg (1.3 to 1,300 Pa), and electrons, ions, and radicals are generated by the glow discharge. Light of various wavelengths including active species such as UV rays and ultraviolet rays is emitted, and these are energy sources for surface treatment. The discharge frequency is a high frequency of 10 Hz to 2 GHz, and nitrogen, oxygen, or the like is used as the plasma generation gas. The plasma processing temperature is in the range of 0 to 200 ° C., and the processing time is about 0.5 to 10 minutes.
[0018]
The infusion tube of the present invention thus produced can be used, for example, as a tube for an infusion / blood transfusion set, a tube for a drug solution container, a tube for blood collection, and the like. Since the infusion tube of the present invention has chemical resistance, non-adsorbing property of a drug, moderate flexibility and rebound resilience, a particularly preferable application is that various drugs are injected from a side injection tube and an infusion pump is used. This is a tube of an infusion injection line where the used liquid is sent.
[0019]
Next, the infusion line will be described.
The infusion infusion line continuously supplies nutrients and the like from the infusion bags and bottles to the patient through the tube, and intermittently converts the drug such as an anticancer drug into the nutrient from the side injection tube provided in the tube. It is used to inject, mix, and administer to patients, and a number of side injection tubes are provided according to the type of drug.
FIG. 1 shows a front view of an example of the infusion line. The infusion line 1 is composed of a bottle needle 2 inserted into an infusion bag or the like at the tip thereof, a drip tube 3 for confirming a drip of the infusion, a side injection tube 4 and a sterilization filter 5, and a tube between each member. 6 are connected. A roller clamp 7 for pressing the tube 6 to control the amount of infusion is provided on the tube. The arrangement of members other than the bottle needle 2 and the dropping cylinder 3 is various. In addition, if necessary, a stopper 8 or the like for temporarily stopping the flow of the infusion by pressing the tube 6 to close the tube is also provided. A connecting member 9 formed in a luer taper or luer lock is attached to the other end of the infusion line 1 depending on how the infusion is administered to a patient. The connection between each member and the tube is fixed by an adhesive or fusion.
[0020]
The side injection tube 4 is a member for injecting one or more medicines at predetermined time intervals into an infusion such as a nutrient continuously flowing down the tube 6 at a predetermined time interval. A straight pipe having a rubber stopper at the tip for injecting the drug into the line and an L-shaped curved pipe through which the infusion flows down are integrally formed on the side of the straight pipe. The lower end and the tip of the L-shaped curved tube are connected to the tube 6 respectively. The side injection pipe having such a structure is usually called an L-shaped side injection pipe. The inner diameter of the tube 6 used for the infusion line 1 is usually about 2.2 to 3.7 mm. The length between the above-mentioned members varies, and the total length of the infusion line 1 is usually about 80 to 200 cm.
[0021]
As a method of transferring the liquid in the infusion infusion line 1, there are a natural fitting method and a pumping method. In the natural fitting method, the infusion flow rate can be controlled to some extent by pressing the infusion tube with the roller clamp 7 (as described above). When it is necessary to precisely control the infusion flow rate, a pump delivery system using an infusion pump is generally employed. Although there are various types of infusion pumps, a peristack finger type pump or a roller type pump is used as an example of an infusion pump that sends a liquid by a drive mechanism that squeezes a tube. As disclosed in Japanese Patent Application Laid-Open No. 61-55393, a Peristack finger type pump is a pump in which a plurality of finger portions successively press a tube to feed a liquid. A roller type pump is disclosed in Japanese Patent Application Laid-Open No. 7-55393. As disclosed in Japanese Patent Publication No. 313593, a pump that feeds liquid by moving a roller while pressing a tube.
[0022]
As described above, the infusion tube of the present invention has a styrene unit content of 5 to 50% by weight in 1,2-PB and a 3,4-vinyl bond ratio of 20% or less in the isoprene block portion. Is formed by molding a resin composition containing 5 to 50% by weight of SIS based on the total amount of the resin composition. The Shore A hardness of the infusion tube of the present invention is 50 to 78, and more preferably 60 to 75. When the Shore A hardness is less than 50, the stiffness of the tube is insufficient, and handling becomes difficult. On the other hand, when it exceeds 78, the flexibility of the tube is insufficient and handling becomes difficult. In addition, when the liquid is sent using an infusion pump having a drive mechanism for intermittently pressing down the tube, the tube becomes hard. Therefore, there is a possibility that stable liquid sending cannot be performed. In addition, infusion pumps are generally equipped with safety devices that stop operation when they detect an increase in stress when the tube is squeezed in consideration of the case where the tube is blocked, so if the Shore A hardness exceeds 78, However, because of its hardness, a conventional infusion pump designed for a tube made of a soft vinyl chloride resin cannot be used.
[0023]
The infusion tube of the present invention preferably has a loss tangent at 25 ° C. of less than 0.15 in dynamic viscoelasticity measurement by longitudinal vibration. If the loss tangent is less than 0.15, the repulsive elasticity of the tube is sufficiently ensured, and the shape of the tube deformed by the external force is promptly recovered. The infusion pump having a stable infusion. Furthermore, even if the tube is deformed due to the movement of the patient, the shape is quickly restored, so that the tube is less likely to be blocked.
[0024]
【Example】
Hereinafter, the present invention will be described more specifically with reference to examples.
In the following, the measurement of "Shore A hardness" was performed as follows.
A micro rubber hardness meter MD-1 manufactured by Kobunshi Keiki Co., Ltd. was used as a hardness measuring device. This micro rubber hardness tester was designed as a 1/5 reduced model of the type A durometer specified in JIS K7215, and the sample obtained from the tube in the following test was small, making it difficult to measure with a type A durometer. It was used because it was. The room temperature during the measurement was 23 ° C., and a tube was cut out into a 3 mm square as a measurement sample.
The measurement of “loss tangent” (loss tangent at 25 ° C. in dynamic viscoelasticity measurement in longitudinal vibration) was performed as follows.
Using a rheograph solid L-1R manufactured by Toyo Seiki Co., Ltd. as a dynamic viscoelasticity measuring device, the temperature is measured in a range of -10 to 50 ° C by a heating method at a measuring frequency of 10 Hz and a heating rate of 5 ° C / min. Was. As a measurement sample, a tube was punched out to a length of 42 mm and a width of 4.5 mm, and the distance between chucks was set to 20 mm.
[0025]
Example 1
1,2-PB (trade name: RB810, manufactured by JSR Corporation) and SIS (styrene unit amount: 14% by weight, ratio of 3,4-vinyl bond in isoprene block portion: 7%) in a weight ratio of 90:10. And kneaded at 120 ° C. using a uniaxial kneader. Next, this kneaded resin composition was kneaded and extruded at 100 to 130 ° C. using a single screw extruder to produce a tube having an outer diameter of 4.45 mm and an inner diameter of 3.15 mm. The resulting tube had a Shore A hardness of 71.3 and a loss tangent of 0.110.
[0026]
Example 2
1,2-PB (trade name: RB810, manufactured by JSR Corporation) and SIS (styrene unit amount: 14% by weight, 3,4-vinyl bond ratio in isoprene block portion: 7%) in a weight ratio of 85:15. And kneaded at 120 ° C. using a uniaxial kneader. Next, this kneaded resin composition was kneaded and extruded at 100 to 130 ° C. using a single screw extruder to produce a tube having an outer diameter of 4.45 mm and an inner diameter of 3.15 mm. The resulting tube had a Shore A hardness of 68.3 and a loss tangent of 0.100.
Further, this tube was attached to an infusion pump (peristaltic finger system), and a liquid sending test was performed by an experimental device shown in FIG. A 10% by weight aqueous glucose solution was fed as a sample solution for 1 hour, and the occurrence of an error between the flow rate and the set flow rate (ml / Hr) was examined. The results are shown in FIG.
In this tube, it was found that the infusion pump could accurately control the infusion flow rate with only a slight outflow error.
[0027]
Example 3
1,2-PB (trade name RB810, manufactured by JSR Corporation) and SIS (styrene unit amount: 14% by weight, 3,4-vinyl bond ratio in isoprene block portion: 7%) in a weight ratio of 80:20. And kneaded at 120 ° C. using a uniaxial kneader. Next, this kneaded resin composition was kneaded and extruded at 100 to 130 ° C. using a single screw extruder to produce a tube having an outer diameter of 4.45 mm and an inner diameter of 3.15 mm. The resulting tube had a Shore A hardness of 63.6 and a loss tangent of 0.097.
[0028]
Comparative Example 1
1,2-PB (trade name: RB810, manufactured by JSR Corporation) was extruded with a single screw extruder at 100 to 130 ° C. to prepare a tube having an outer diameter of 4.45 mm and an inner diameter of 3.15 mm. The resulting tube had a Shore A hardness of 82.2 and a loss tangent of 0.130.
Further, this tube was mounted on an infusion pump (peristaltic finger system), and an experiment was performed using the experimental apparatus shown in FIG. 2 to perform an infusion test by the same operation as in Example 2. Safety device was activated and operation was disabled.
[0029]
Comparative Example 2
1,2-PB (trade name: RB810, manufactured by JSR) and SIS (styrene unit amount: 20% by weight, ratio of 3,4-vinyl bond in isoprene block portion: 70%) in a weight ratio of 85:15. And kneaded at 120 ° C. using a uniaxial kneader. Next, this kneaded resin composition was kneaded and extruded at 100 to 130 ° C. using a single screw extruder to produce a tube having an outer diameter of 4.45 mm and an inner diameter of 3.15 mm. The resulting tube had a Shore A hardness of 70.5 and a loss tangent of 0.270.
This tube was attached to an infusion pump (peristaltic finger method), and a liquid sending test was performed by the experimental device shown in FIG. The results are shown in FIG.
This tube produced a large negative outflow error as compared with the tube of Example 2, and it was apparent that it was difficult to accurately control the infusion flow rate with the infusion pump.
[0030]
【The invention's effect】
According to the present invention, by molding a resin composition in which a specific amount of a styrene-isoprene-styrene triblock copolymer having a specific structure is blended with 1,2-polybutadiene, a moderate flexibility while having rebound resilience is obtained. Is provided, a tube made of a non-polyvinyl chloride material which is easy to handle, can be pressed, and has shape recovery properties is obtained. By configuring the infusion line using the infusion tube of the present invention, an infusion line that is attached to the infusion pump and that can accurately control the infusion flow rate is provided.
[Brief description of the drawings]
FIG. 1 is a schematic view showing an example of an infusion line.
FIG. 2 is a schematic view showing an experimental device for a liquid sending test using an infusion pump using tubes of Example 2 and Comparative Example 2.
FIG. 3 is a graph showing the results of a liquid sending test using an infusion pump using tubes of Example 2 and Comparative Example 2.
[Explanation of symbols]
1: infusion injection line 2: bottle needle 3: dropping tube 4: side injection tube 5: sterilization filter 6: tube 7: roller clamp 8: stopper 9: joining member 10: infusion bag 11: sample tube 12: infusion pump 13 ： Beaker 14 ： Stand

Claims (2)

A resin composition obtained by mixing a styrene-isoprene-styrene triblock copolymer with 1,2-polybutadiene is molded. (1) The compounding amount of the copolymer is 5 with respect to the total amount of the resin composition. (2) the copolymer has a styrene unit content of 5 to 50% by weight, and a ratio of 3,4-vinyl bonds in the isoprene block portion is 20% or less; 3) An infusion tube having a Shore A hardness of 50 to 78. The infusion tube according to claim 1, wherein a loss tangent at 25 ° C in dynamic viscoelasticity measurement by longitudinal vibration is less than 0.15.

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