JPH0243507B2 - - Google Patents

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to medical instruments. More specifically, the present invention relates to a medical device having a pumpable cylindrical portion, such as an infusion set or a blood transfusion set. Prior Art Circuits for transporting medical liquids such as drug solutions and blood are used in medical procedures such as infusions or blood transfusions, and in extracorporeal blood processing such as artificial dialysis and artificial heart-lung machines. Such a medical liquid transport circuit is a cylindrical body with an infusion port for dripping medical liquid into the inside of an infusion barrel, etc., which is used to drip or flow medical liquid and visually confirm the flow rate. and a flexible tube connected to the tube for transporting medical liquid. The cylindrical body incorporated in such a medical liquid transport circuit is assembled by attaching flexible tubes for transporting medical liquid to both ends of a cylindrical body made of soft or semi-hard vinyl chloride resin. For this assembly, the cylindrical body is made by crushing and high-frequency welding both ends of an extruded cylindrical tube, separately molding parts such as the drip opening, and the flexible tube using an organic solvent such as cyclohexanone or tetrahydrofuran. There are also those in which a hard cap with a drip opening and the like is attached to both ends of the cylindrical body using a solvent. There are other cylindrical bodies made of soft or semi-hard vinyl chloride resin by blow molding or injection molding, but in any case, the cylindrical body is made of a soft material with a drip opening made of a hard material. In order to attach the formed cap part, it is joined by adhesive using an organic solvent. However, bonding using an organic solvent has the disadvantage that the solvent dissolves and remains in the internal space or in the bonded portion and surrounding materials. Solvent that remains dissolved inside the material not only weakens the strength of the material, but also has the potential to be eluted into the medical liquid during use, along with the solvent that remains in the internal space. It had some very unpleasant problems. In addition, as mentioned above, the soft vinyl chloride resin that constitutes the cylindrical body has low rebound elasticity and therefore has a weak restoring force to its original shape during pumping.On the other hand, when the amount of plasticizer is reduced to increase the restoring force, The drawback was that the body would experience crazing after several pumps. In addition, the resins had disadvantages in that they changed color when subjected to gamma ray sterilization, produced a large amount of eluate, caused PH changes, and consumed a large amount of potassium permanganate. Furthermore, materials that are transparent and flexible enough to be pumped include ethylene-vinyl acetate copolymer, ethylene-ethyl acrylate copolymer,
There are styrene-butadiene copolymers, modified polymers of poly(4-methylpentene-1), etc., but when the soft grades of these modified polymers are molded into thin walls, they do not crack due to being crushed during pumping. This is not desirable as a material for pumping because it may allow microorganisms to invade. Styrene-butadiene copolymers are not suitable for practical use because they lack the ability to recover to their original shape when compressed for pumping. Ethylene-ethyl acrylate copolymer has a problem with the toxicity of ethyl acrylate, and ethylene-vinyl acetate copolymer has insufficient transparency. Furthermore, due to their flexibility, these resins absorb ultrasonic vibrations during fusion bonding using an ultrasonic welder, and are not preferred for bonding using an ultrasonic welder. OBJECT OF THE INVENTION It is therefore an object of the present invention to provide a novel medical device. Another object of the invention is to
It is an object of the present invention to provide a medical device having a transparent pumpable cylindrical body, such as an infusion set, a blood transfusion set, etc. These objectives are to provide a medical device having a flexible and transparent cylindrical body, in which the cylindrical body is made of 60 to 99 parts by weight of a propylene-α-olefin copolymer and an ethylene-α-olefin copolymer. This is achieved by a medical device characterized in that it is formed from a resin composition comprising 40 to 1 part by weight. Further, the present invention provides a method in which the α-olefin content in the propylene-α-olefin copolymer is 10 to 60 mol%, and the α-olefin content in the ethylene-α-olefin copolymer is 10 to 60 mol%. % medical equipment. Furthermore, the present invention provides that the α-olefin in the propylene-α-olefin copolymer is ethylene or butene-1, and the α-olefin in the ethylene-α-olefin copolymer is butene-1.
It is a medical device. Further, the present invention is a medical device in which the amount of the ethylene-α-olefin copolymer blended is 30-5 parts by weight with respect to 70-95 parts by weight of the propylene-α-olefin copolymer. Furthermore, the present invention is a medical device in which the cylindrical body is an infusion tube. Specific Structure of the Invention The resin composition used to form the medical device according to the present invention is composed of 60 to 99 parts by weight of a propylene-α-olefin copolymer and 40 to 1 part by weight of an ethylene-α-olefin copolymer. It is what it is. Propylene-α-olefin copolymer is a random or block copolymer of propylene and α-olefin, and its weight average molecular weight is 20,000 to 20,000.
1,000,000, preferably 50,000 to 500,000. The comonomer α-olefin includes ethylene,
Examples include butene-1, pentene-1,4-methylpentene-1, etc., and ethylene or butene-1 is preferred. The content of α-olefin in the copolymer is 10 to 60 mol%, preferably 10 to 50 mol%, more preferably 15 to 40 mol% in the case of ethylene.
mol%, 15 for α-olefins with C4 or _higher
~35 mol%. For example, Tafmar XR106L, Tafmar XR107L, Tafmar
XR106 (all manufactured by Mitsui Petrochemical Industries, Ltd.),
Examples include SPX-8400 (manufactured by Mitsubishi Yuka Co., Ltd.). That is, if the content of α-olefin is less than 10 mol%, the strength of medical instruments manufactured with a resin composition using the copolymer after radiation sterilization will decrease, and cracks may occur during pumping. Because it will be. On the other hand, when the content of α-olefin exceeds 60 mol%, medical devices manufactured using resin compositions using the copolymer cannot be fused by ultrasonic waves, and when pumping Restore speed slows down. In addition, the ethylene-α-olefin copolymer is
It is a random or block copolymer of ethylene and α-olefin, and its weight average molecular weight is
20,000 to 1,000,000, preferably 50,000 to 500,000. The comonomer α-olefin includes butene-1, butene-2, pentene-1,4-methylpentene-1, etc., and butene-1 is preferred. The content of α-olefin in the copolymer is 10
~60 mol%, preferably 10-50 mol%, more preferably 15-40 mol%. Examples include Tafmer A and Tafmer P (both manufactured by Mitsui Petrochemical Industries, Ltd.). That is, if the content of α-olefin is less than 10 mol %, the transparency of medical devices manufactured using a resin composition using the copolymer will decrease. Furthermore, if the content of α-olefin exceeds 60 mol %, ultrasonic fusion cannot be performed on medical instruments manufactured using a resin composition using the copolymer. The resin composition used to form the medical device according to the present invention is a propylene-α-olefin copolymer.
60 to 99 parts by weight of ethylene-α-olefin copolymer 40 to 1 part by weight, preferably propylene-
30-5 parts by weight of ethylene-α-olefin copolymer is blended with 70-95 parts by weight of α-olefin copolymer. In other words, if the blending amount of the ethylene-α-olefin copolymer exceeds 40 parts by weight, the soft cylindrical part of the medical device formed using the resulting resin composition becomes too soft, resulting in difficulty during pumping. This is because not only the restoring force becomes insufficient, but also the fusion properties such as thermal fusion properties and ultrasonic fusion properties with the polypropylene constituting the cap portion etc. deteriorate. On the other hand, if the blending amount of the ethylene-α-olefin copolymer is less than 1 part by weight, it becomes impossible to suppress bleeding, which is a general tendency in these soft olefin resins. Furthermore, a nucleating agent may be added to the resin composition, thereby further improving moldability and suppressing bleeding, which is a general tendency in these soft olefin resins. The amount of the nucleating agent added is 0.5 to 0.05% by weight, preferably 0.3 to 0.1% by weight. Examples of such nucleating agents include dibenzal sorbitol, tribenzal sorbitol, di(methylbenzal) sorbitol, tri(methylbenzal) sorbitol, and specifically, gelol D,
Examples include Gel All T, Gel All MD (all manufactured by Shin Nippon Chemical Co., Ltd.), and EC-1 (manufactured by EC Chemical Co., Ltd.). The resin composition is colorless and transparent, and includes, for example,
Haze 20% as measured by ASTMD1003
or less, preferably 15% or less, more preferably 10%
% or less. Also, Young's modulus is 10,000~1000
Kg/cm ² , preferably 8000 to 3000 Kg/cm ² . Note that the resin composition contains the propylene-α
-Olefin copolymer and ethylene-α-olefin copolymer, and if necessary, a nucleating agent and other additives are blended, and the mixture is uniformly kneaded by dry blending, Ruder blending, or the like. Further, the resin composition thus obtained can be used to obtain a medical device having a predetermined shape and structure by a molding method depending on the purpose, such as injection molding, blow molding, or extrusion molding. Hereinafter, an example of the medical device according to the present invention will be shown along with the accompanying drawings. That is, FIG. 1 shows an example of an infusion set having a drip tube, which is formed near the tip of the opening of a soft and transparent cylindrical portion 1 manufactured by injection molding the resin composition. A flange portion 4 formed near the opening tip of a hard cap portion 3 manufactured by injection molding polypropylene or the like is brought into contact with the flange portion 2.
A drip barrel is formed by activating a vibrator (not shown) of an ultrasonic welder from the side to perform ultrasonic welding. A bottle needle 5 is integrally formed in the cap portion, and the bottle needle 5 is covered with a protective cap 6 if necessary. Further, a port 7 is formed at one end of the soft transparent cylindrical portion 1, and a flexible tube 8 for transporting medical liquid is connected to the port 7. A soft connector 9 made of rubber and a connector 10 made of a hard material are connected to the tip of the flexible tube 8, if necessary, and a needle 10a for penetrating a vein is connected to the tip of the connector 10, if necessary. teeth,
A protective cap 10b is covered if necessary. In addition, in the middle part, if necessary, cleanse 19
is attached and configured to clamp the flexible tube 8. FIG. 2 shows another embodiment of the invention. That is, a hard cap part manufactured by injection molding polypropylene or the like is attached to the flange part 12 formed near the tip of the opening of the soft and transparent cylindrical part 11 manufactured by injecting the resin composition. Flange portion 1 formed near the tip of the opening of 13
4 are brought into contact with each other, and a vibrator (not shown) of an ultrasonic welder is activated from the flange portion 14 side to perform ultrasonic welding, thereby forming a drip tube. Note that a port 15 is formed in the cap portion, and a flexible tube 16 for transporting medical liquid is connected to the port 15. Further, a port 1 is provided at one end of the soft transparent cylindrical portion 11.
7 is formed, and a flexible tube 18 for transporting medical liquid is connected to the port 17. A connector (not shown) is connected to the tip of the flexible tube 18 if necessary, and a clamp (not shown) is attached to the intermediate part of the flexible tube 18 if necessary to clamp the flexible tube 18. It is composed of FIG. 3 shows still another embodiment of the present invention, in which a flexible and transparent cylindrical portion 21 is formed near the tips of the openings at both ends of the soft and transparent cylindrical portion 21 manufactured by injection molding the resin composition. Flange portions 22a, 22b
Then, the flanges 24a and 24b formed near the opening tips of the hard cap parts 23a and 23b manufactured by injection molding polypropylene are brought into contact with each other, and the vibrator of the ultrasonic welder ( (not shown) to perform ultrasonic welding, a dotted cylinder is formed. Note that the caps 23a and 23b have ports 25
a, 25b are formed, the ports 25a, 25b
Flexible tubes 26a and 26b for conveying medical liquid are connected to the tubes 26a and 26b. Furthermore, connectors and needles are connected to the tips of these tubes 26a and 26b, if necessary. FIG. 4 shows a bellows for a suction device according to another embodiment of the present invention, in which a soft transparent bellows 3 made of the resin composition by blow molding is shown.
A drain tube 32 is connected to the drain tube 1, a connector 33 is connected to the tip thereof, and a cleanser 34 is attached in the middle thereof. On the other hand, a suction tube 35 is connected to the bellows 31, and a suction catheter 37 is further attached to a connector 36 attached to the tip thereof, if necessary. Furthermore, other embodiments of the present invention include a drug solution bottle 38 as shown in FIG. 5, a bellows hose 39 for a respiratory circuit as shown in FIG.
There is a dropper 40 as shown in the figure. Medical instruments such as those described above may be sterilized by various methods. Examples of sterilization methods include steam sterilization using an autoclave, gas sterilization using ethylene oxide gas, and radiation sterilization using radiation irradiation. Radiation sterilization is preferred because it eliminates thermal deformation and residual gas. Radiation includes gamma rays, electron beams, etc., and by using gamma rays in particular, a sufficient sterilization effect can be obtained with a small dose. Usually the irradiation dose is 1~
5 Mrad, preferably 1.5-4 Mrad. Another advantage of using radiation sterilization is that instead of ultrasonic welding, an ultraviolet curable adhesive is used to join the tubular part and the cap, and the radiation energy of the sterilization process is used to bond the cap. It is possible to cure the agent. The medical device according to the present invention thus manufactured is used in the following manner. for example,
In the case of an infusion set as shown in FIG. 1, after removing the protective cap 6, insert the bottle needle 5 into the rubber stopper (not shown) of the mixed injection port of the infusion bag, and
When the drip tube is pressed once or several times to expel the air inside to the infusion bag side, the medical liquid flows into the drip tube. When a portion (for example, about 1/2) of this liquid has accumulated in the drip tube, it is discharged from the flexible tube 8, and when it begins to flow out from the venous puncture needle 10a connected to the connector 10, the liquid is discharged from the tube 8. Since the air is completely excluded, it is connected to the human body (for example, a vein) and the medical liquid is supplied to the human body while the outflow is controlled by the drainer 10. Further, similar operations are performed for the infusion set shown in FIGS. 2 and 3. Next, the present invention will be explained in more detail by giving Examples. Reference Example 1 Propylene-α-olefin copolymer (α-olefin:butene-
1) (Product name SP×8400, manufactured by Mitsubishi Yuka Co., Ltd.) 90
For medical use, 10 parts by weight of ethylene-α-olefin copolymer (α-olefin:butene-1) (trade name Tafmer A20090, manufactured by Mitsui Petrochemical Industries, Ltd.) with a weight average molecular weight of about 200,000 are Ruder-blended. A resin composition was obtained. This resin composition has a wall thickness of 0.6 mm, an outer diameter of 15 mm, and a length of
It was injection molded into a 50mm cylindrical shape. The results of physical property tests on this product were as shown in Table 1. Reference Comparative Examples 1 to 6 Soft vinyl chloride resin (hereinafter referred to as
It is called soft PVC. ), ethylene-vinyl acetate copolymer (hereinafter referred to as EVA) with a weight average molecular weight of approximately 200,000, polypropylene (hereinafter referred to as PP) with a weight average molecular weight of approximately 300,000, weight average molecular weight approximately
200,000 polyethylene (hereinafter referred to as PE), propylene-butene-1 copolymer (Tafmer x R106)
(hereinafter referred to as copolymer A) and propylene-
Butene-1 copolymer (Tafmer x R106) mixed with 0.1% by weight of di(methylbenzal)sorbitol (Gelol MD; manufactured by Shin Nippon Rika Co., Ltd.) as a nucleating agent (hereinafter referred to as copolymer B).
A cylindrical body similar to that of Example 1 was injection molded,
When similar tests were conducted, the results shown in Table 1 were obtained. In addition, each test in this specification was conducted as follows. (1) Transparency: It was cut in the axial direction, pressed and spread into a sheet, and the haze degree was measured according to ASTM D1003. (2) Crushing stress: Maximum stress when crushed into a flat plate from the direction perpendicular to the axis. (3) Crazing: In the test (2), when the stress was removed, it was checked whether the crease marks remaining on the sample would whiten. (4) Heat resistance: Temperature at which the roundness of the cross section deteriorates by ±2 mm or more. (5) Recovery time: The time it takes for the cross section to recover to its roundness of ±0.5mm after the stress is removed in the test in (2). Examples 2 to 5 Propylene-α-olefin copolymer (α-olefin: ethylene) having a weight average molecular weight of about 300,000
(SPX-8400, manufactured by Mitsubishi Yuka Co., Ltd.) 100 parts by weight was added to 100 parts by weight of ethylene-α-olefin copolymer (α-olefin:butene-
1) was Ruder-blended in the numbers shown in Table 2 to obtain medical resin compositions. When these compositions were subjected to the same tests as in Example 1, the results shown in Table 2 were obtained.

【table】

【table】

[Table] Example 1 Ethylene content 0-3% by weight, weight average molecular weight approx.
250,000 polypropylene was injection molded to produce a hard cap part 3 having a bottle needle 5 as shown in FIG. On the other hand, the resin composition of Reference Example 1 was injection molded to produce a soft transparent cylindrical part 1 having a port 7 at one end as shown in FIG. The flanges 2 and 4 of both were brought into contact with each other and fused together using an ultrasonic welder to form a drip tube. A soft vinyl chloride resin tube 8 was connected to the port 7 of the drip tube thus obtained, and connectors 9 and 10 and a venous piercing needle 10a were attached to the tip thereof. The thus obtained infusion set was sterilized by irradiation with 3 Mrad of gamma rays. Regarding this sterile infusion set, Ministry of Health and Welfare Notification No. 301 dated August 10, 1970
When dissolution tests and biological tests were conducted according to the ``Disposable Blood Transfusion Set and Infusion Set Standards'', the results shown in Table 3 were obtained. Example 2 Ethylene content 0-3% by weight, weight average molecular weight approx.
By injection molding a polypropylene composition made by blending 200,000% polypropylene with 20% by weight of mica,
A hard cap part 13 as shown in FIG. 2 was manufactured. On the other hand, the resin composition of Reference Example 2 was injection molded to produce a soft transparent cylindrical part 11 having a port 17 at one end as shown in FIG. The flanges 12 and 14 of both were ultrasonically bonded in the same manner as in Example 1, the flexible tubes were connected, and gamma ray sterilization and testing were performed in the same manner, and the results shown in Table 3 were obtained. Ta. Comparative Example The hard cap part 3 is injection molded with hard vinyl chloride resin (average degree of polymerization 800), while the soft transparent cylindrical part 1 is made of soft vinyl chloride resin (average degree of polymerization 1100, di-2-ethylhexyl phthalate content 40). The drip tube was manufactured in the same manner as in Example 1, except that it was blow molded (% by weight) and bonded with a solvent using cyclohexanone, and then gamma ray sterilized and tested, and the results shown in Table 3 were obtained. Obtained.

[Table] Test
Specific Effects of the Invention As described above, the present invention provides a medical device having a soft and transparent cylindrical body, in which the cylindrical body is made of a propylene-α-olefin copolymer of 60 to 99%.
Parts by weight and ethylene-α-olefin copolymer
Since this is a medical device characterized by being formed from a resin composition consisting of 40 to 1 part by weight, the addition of the ethylene-α-olefin copolymer not only further improves transparency but also provides functionally large The bending marks on the members of medical instruments that require deformation do not turn white, and the recovery time when the deformation is removed is shorter than that of conventional soft vinyl chloride resins.
Further, since large deformation is possible with small force, pumping operation becomes easy. Furthermore, by making the material thinner, the cost can be reduced compared to conventional soft vinyl chloride resins, etc., and it is also safe because it does not require a migratory plasticizer. In addition, ultrasonic fusion, heat fusion, etc. can be used to bond to polypropylene used as a hard member, and the bonding strength is extremely high.

[Brief explanation of the drawing]

1-3 are sectional views showing each embodiment of the medical instrument according to the present invention, and FIGS. 4-7 are side views showing other embodiments. 1, 11, 21... Soft transparent cylindrical part, 2, 4,
12, 14, 22a, 22b, 24a, 24b...
...Flange part, 3, 13, 23... Hard cap part, 8, 16, 18, 26a, 26b... Flexible tube.

Claims (1)

[Scope of Claims] 1. A medical device having a soft and transparent cylindrical body, wherein the cylindrical body is made of 60 to 99 parts by weight of a propylene-α-olefin copolymer and an ethylene-α-olefin copolymer.
A medical device characterized in that it is formed from a resin composition comprising 40 to 1 part by weight of an olefin copolymer. 2 α in propylene-α-olefin copolymer
- The medical device according to claim 1, wherein the olefin content is 10 to 60 mol%, and the α-olefin content in the ethylene-α-olefin copolymer is 10 to 60 mol%. 3 α in propylene-α-olefin copolymer
3. The medical device according to claim 2, wherein the -olefin is ethylene or butene-1, and the α-olefin in the ethylene-α-olefin copolymer is butene-1. 4 Propylene-α-olefin copolymer 70-95
The medical device according to claim 3, wherein the amount of the ethylene-α-olefin copolymer blended is 30 to 5 parts by weight. 5. The medical device according to any one of claims 1 to 4, wherein the cylindrical body is an infusion tube.