JPH01104269A - Medical soft resin composition and medical utensil - Google Patents

Abstract

PURPOSE:To obtain a medical utensil excellent in the preservability of erythrocytes and having high physiological safety, autoclave sterilizable heat resistance, high transparency and flexibility, by compounding specific monocarboxylic ester with a soft resin composition containing no plasticizer. CONSTITUTION:The medical utensil is constituted of a soft resin composition prepared by compounding a soft resin composition containing no plasticizer with monocarboxylic ester represented by RCOOR' (wherein R and R' are respectively a 3C or more linear hydrocarbon group and the sum of the number of carbon atoms of R and R' is 11-30 and at least one of R and R' has a branch structure). When this soft resin composition is brought into contact with blood, the hemolysis of erythrocytes is prevented by the action of the monocarboxylic ester compound eluted and transferred from the resin composition and, since a substance suppressing platelet coagulating capacity is not eluted, this composition is excellent in the safety to a living body and has excellent protective action to erythrocytes.

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to a medical soft resin composition and a medical device. Specifically, the present invention relates to medical soft resin compositions and medical devices that have extremely high safety and do not cause hemolysis when they come into contact with blood.

(Prior Art) Currently, blood storage containers or other medical devices include:
Those made of soft vinyl chloride resin are widely used. By the way, the soft vinyl chloride resin used for medical purposes as described above usually uses di-2-ethylhexyl phthalate (DOP) as a plasticizer.

However, phthalate ester plasticizers generally have a high migration property, so when a soft vinyl chloride resin such as the one mentioned above comes into contact with blood, di-2-ethylhexyl phthalate may be eluted into the blood. Are known(
Medical Science 54 221 (1984)). this g 2
- Ethylhexyl phthalate has been reported to suppress the aggregation ability of platelets (Journal of the Japanese Society of Blood Transfusion, 2B (
3) 282' (1981)), for example, if blood is stored using such a storage container made of soft vinyl chloride resin, there is a risk that di-2-ethylhexyl phthalate may enter the body along with the stored blood during blood transfusion. This fact was problematic in terms of its effect on platelet function.

In order to solve these problems, the use of materials that do not contain di-2-ethylhexyl phthalate was considered, but
It has become clear that when blood is stored in a storage container made of a material that does not contain di-2-ethylhexyl phthalate, red blood cells become hemolyzed during storage. When we investigated the cause of this, we found that it is because di-2-ethylhexyl phthalate has a hemolysis-inhibiting effect (
Blood 6461270~ (1984) [BIood
6461270- (1984) ] "). In other words, when blood is stored in a conventional blood storage container made of soft vinyl chloride resin containing di-2-ethylhexyl phthalate as a plasticizer, Di-2-ethylhexyl phthalate eluted into the blood suppressed hemolysis of red blood cells.

For these reasons, although there are concerns about the effects of di-2-ethylhexyl phthalate on living organisms, soft vinyl chloride resin containing di-2-ethylhexyl phthalate is recommended as a medical soft resin composition constituting medical containers. Currently, it is used.

(Problems to be Solved by the Invention) Therefore, an object of the present invention is to provide a novel medical soft resin composition and a medical device.

Another object of the present invention is to provide a medical soft resin composition and a medical device that have excellent preservability for red blood cells. A further object of the present invention is to provide a medical soft resin composition and a medical device with high physiological safety. The present invention furthermore provides autoclave sterilizable heat resistant;
The purpose of the present invention is to provide medical resin compositions and medical devices that have high transparency, flexibility, and processability.

(Means for Solving the Problems) The above-mentioned points are that -maximum (I) RCO○R' (I) (wherein R and R' are each carbon A medical soft material containing a monocarboxylic acid ester, which is a chain hydrocarbon group having a number of 3 or more, and the sum of the carbon numbers of R and R' is 11 to 30. This is achieved by a resin composition.

The present invention also provides a medical soft resin composition containing 5 to 35% by weight of a monocarboxylic acid ester represented by general formula (1).

The present invention further provides a medical soft resin composition in which at least one of R and R' in general formula (I) has a branched structure. The present invention further provides a medical soft resin composition, wherein the compound represented by the general formula (I) is isopropyl isolaurate, isoprofluoroate, 2-ethylhexyl isostearate or 2-ethylhexyl-2-ethylhexanoate. This shows that. The present invention also provides that the soft resin is internally plasticized vinyl chloride resin, polyester, polyurethane, ethylene-
This refers to a medical soft resin composition that is a vinyl acetate copolymer or a polymer blend of polyvinyl chloride and polyurethane, ethylene polymer, or caprolactone polymer. The present invention further provides a medical soft resin composition in which the internally plasticized vinyl chloride resin is a urethane-vinyl chloride copolymer, a vinyl acetate-vinyl chloride copolymer, or an ethylene-vinyl acetate-vinyl chloride copolymer. It is something.

In addition, in the above-mentioned terms, in a soft resin composition that does not contain a plasticizer, -maximum (1) % formula % () (wherein R and R' are each a chain hydrocarbon group having 3 or more carbon atoms. , and the sum of the carbon numbers of R and R' is 11
~30. ) This is achieved by a medical device characterized in that it is substantially composed of a soft resin composition containing a monocarboxylic acid ester represented by the following formula.

The present invention also provides a medical device characterized in that it is substantially composed of a soft resin composition containing 5 to 35% of a monocarboxylic acid ester represented by general formula (I). . The present invention further provides a medical device in which at least one of R or R' in general formula (I) has a branched structure. The present invention further provides that the compound represented by the general formula (1) is isopropyl isolaurate, inpropyl oleate, 2-ethylhexyl isostearate or 2-ethylhexyl-2-
1 shows a medical device that is ethylhexanoate. The present invention also provides that the soft resin is an internally plasticized vinyl chloride resin composition, polyethylene, thermoplastic polyester, polyurethane, ethylene-vinyl acetate copolymer, or a combination of polyvinyl chloride and polyurethane, ethylene polymer or caprolactone polymer. 1 illustrates a medical device that is a polymer blend. The present invention further provides that the internally plasticized vinyl chloride resin is a urethane-vinyl chloride copolymer, a vinyl acetate-vinyl chloride copolymer, or an ethylene-vinyl chloride copolymer.
This figure shows a medical device that is a vinyl acetate-vinyl chloride copolymer. The present invention also provides a medical device characterized in that it is a blood storage container. The present invention also provides medical devices that are capable of withstanding autoclave sterilization.

(Function) Therefore, the medical soft resin composition of the present invention contains the general formula % formula % () (wherein R and R' each have 3 or more carbon atoms is a chain hydrocarbon group, and the sum of the carbon numbers of R and R' is 11
~30. ) The biggest feature is that it is made by adding a monocarboxylic acid ester represented by. Surprisingly, the monocarboxylic acid ester compound represented by the general formula (I>) has the same effect of preventing red blood cell hemolysis as di-2-ethylhexyl phthalate, and on the other hand, it has the same effect as di-2-ethylhexyl phthalate. It was found that the monocarboxylic acid ester compound represented by the above general formula (I>) has sufficient compatibility with various soft resins. Therefore, if the J-monocalleboxate compound is blended into a soft resin composition that does not contain a plasticizer, there will be no fear of safety issues due to plasticizer elution, and it will be effective against red blood cells when it comes into contact with blood. It is possible to obtain a soft resin composition with good storage stability.In other words, when the soft resin composition comes into contact with blood, due to the action of the monocarboxylic acid ester compound that elutes and migrates from the resin composition. Hemolysis of red blood cells is prevented, and on the other hand, substances that inhibit platelet aggregation ability, such as di-2-ethylhexyl phthalate, are not eluted, so it is extremely safe for living organisms and has an excellent protective effect on red blood cells. Therefore, the medical soft resin composition of the present invention is suitable as a material for medical devices, and molded products made using the material have excellent safety, Because it has processability, flexibility, transparency, and heat resistance, it can be used as a medical device to exhibit its effects, and its effects are especially remarkable when used as a medical device that comes into contact with body fluids such as blood. be.

Hereinafter, the present invention will be explained in more detail based on embodiments.

The soft resin used in the medical soft resin composition according to the present invention is a plasticizer (in this specification, "plasticizer" refers to an external plasticizer in a narrow sense unless otherwise specified. ), the medical soft resin composition of the present invention does not contain a plasticizer.

Examples of such soft resins include internally plasticized vinyl chloride resin, polyethylene, thermoplastic polyester,
Polyurethane, ethylene-vinyl acetate copolymer, and polyvinyl chloride and polyurethane, ethylene polymer (
Examples include, but are not limited to, Elvaloy () or polymer blends with caprolactone-based polymers. Internally plasticized vinyl chloride resins include, for example, urethane-vinyl chloride copolymers, vinyl acetate-vinyl chloride copolymers, and ethylene-vinyl acetate-vinyl chloride copolymers. In the system resin, the weight ratio of the vinyl chloride monomer component and the copolymerized monomer component having a plasticizing effect is 7:3 to 3, more preferably 6:
The ratio is about 4 to 4:6. The polyethylene is low density polyethylene, preferably with a melt index of 0.
A value of about 1 to 5 is preferable. Examples of thermoplastic polyester include polyethylene terephthalate film. Polyurethanes include polyester-type polyurethanes and polyether-type polyurethane elastomers, and polyether-type segmented polyurethanes are preferred. Furthermore, as for the ethylene-vinyl acetate copolymer, the weight ratio of the ethylene monomer component and the vinyl acetate monomer component is 95:5 to 70:30.
, more preferably about 90:10 to 80:20.

In the medical soft resin composition of the present invention, as described above, the soft resin component is not particularly limited, but preferred examples include polyurethane and ethylene-vinyl acetate copolymer.

Therefore, in the medical soft composition of the present invention, - maximum (
I) RCOOR' (I) (However, in the formula, R and R' are each a chain hydrocarbon group having 3 or more carbon atoms, preferably 3 to 22 carbon atoms, most preferably 3 to 18 carbon atoms, and the combination of R and R' Carbon bedding is 11-30,
Preferably it is 11-21. ) is blended with a monocarboxylic acid ester. This monocarboxylic acid ester represented by maximum (I>) acts as a hemolysis inhibitor in the medical soft resin composition of the present invention. That is, when blood comes into contact with a product made of the medical soft resin composition of the present invention. At this time, the general formula (I) eluted and migrated from the composition
The monocarboxylic acid ester represented by > has a protective effect on red blood cells.

- In the monocarboxylic acid ester represented by maximum (I>, R and R' have 3 or more carbon atoms, because if the number of carbon atoms is a chain hydrocarbon chain of less than 3, toxicity of the compound may occur. This is because it is not appropriate to incorporate it into a medical soft resin composition.
In the monocarboxylic acid ester represented by I), R
The reason why the sum of the carbon numbers of and R' is set to 11 to 30 is that if the sum of the carbon numbers is less than 11, the hemolysis prevention effect will be reduced, whereas if the sum of the carbon numbers exceeds 30, various soft lightning This is because the compatibility with fat decreases, making uniform dispersion in the soft resin composition difficult. Furthermore, in the monocarboxylic acid ester represented by maximum (1), at least one of the chain hydrocarbon groups R and R' has a branched structure, which increases the compatibility with various soft 185 fats and the effect of preventing hemolysis. more preferred.

Furthermore, the chain hydrocarbon groups R and R' may be saturated or unsaturated chain hydrocarbon groups. -Specifically, monocarboxylic acid esters represented by maximum (1) include 2-ethylhexylbutyrate, 2-ethylhexylbutyrate,
Ethylhexyl isobutyrate, isohexyl valerate, 2-ethylhexyl valerate, isohexyl pivalate, 2-ethylhexyl pivalate, isopentylhexanoate, isohexylhexanoate, 2-ethylhexylhexanoate , inbutyl-2-ethylhexanoate, isopentyl-2-ethylhexanoate, 2-ethylhexyl-2-ethylhexanoate, isopropyl oleate, inbutyl oleate, 2
-ethylhexyl oleate, isopropyl laureton butyl laurate, 2-ethylhexyl laurate,
2-ethylhexyl isolaurate, isopropyl myristate, inbutyl myristate, 2-ethylhexyl myristate, isopropyl palmitate, isobutyl palmitate, 2-ethylhexyl palmitate, isopropyl stearate, inbutyl stearate, 2
- Ethylhexyl stearate, isopropyl isostearate, isobutyl isostearate, 2-ethylhexyl isostearate, isopropyl oleate, imbutyl oleate, 2-ethylhexyl oleate, etc., but are of course not limited to these. It's not like that. Preferred among these compounds are isopropyl isolaurate, isopropyl oleate, 2-ethylhexyl isostearate, and 2-ethylhexyl 2-ethylhexanoate, and most preferred is isopropyl isolaurate.

Such a monocarboxylic acid ester represented by -maximum (1) is 5 to 3 in the medical soft resin composition of the present invention.
5% by weight, more preferably 10-25% by weight. That is, if the amount of the monocarboxylic acid ester is less than 5% by weight, the effect of suppressing hemolysis of red blood cells will not be sufficient, while if it exceeds 1% by weight, there is a risk that the physical properties of the soft resin composition will be deteriorated. Because there is.

Furthermore, additives such as various stabilizers, lubricants, and antioxidants may be added to the medical soft resin composition of the present invention, if necessary.

The medical soft resin composition of the present invention may be molded by any of the various methods used for conventional soft resin compositions, such as calendar molding, extrusion molding, blow molding, and plastisol molding. This is possible, and as an adhesion method, high frequency fusion, heat fusion, etc. are possible depending on the type of soft resin.

The medical device of the present invention contains a soft resin that does not contain a plasticizer.
The above general formula (I >RCO○R' (I > (wherein R
and R' are each a chain hydrocarbon group having 3 or more carbon atoms, and the sum of the carbon numbers of R and R' is 11 to 30. ), and has excellent physical properties such as safety, processability, flexibility, and heat resistance. In particular, it has an excellent inhibitory effect on hemolysis of red blood cells. Therefore, the medical device of the present invention includes:
It preferably includes medical devices that come into contact with blood or body fluids, such as blood storage containers such as blood bags, catheters, blood transfusion sets, and blood circuits, but also packaging containers for medical devices, packaging containers for drugs such as tablets, etc. It is included.

Next, with reference to the drawings, one implementation of the medical device according to the present invention will be explained using a blood bag as an example. That is, FIG. 1 shows a blood bag, and the blood collection bag 3 made of the above-mentioned soft resin composition is equipped with a plurality of peel-tab-equipped discharge ports 1 and a connecting discharge port 2, and its peripheral portion 4 is heated by high-frequency heating. Alternatively, it is heat-sealed by other heating means, and a blood collection tube 6 made of the above-mentioned soft resin composition and communicating with the internal space 5 of the blood collection bag 3 is connected. Further, a puncture needle 8 is attached to a needle base 7 provided at the tip of the blood collection tube 6, and a cap 9 is attached to this puncture needle 8.

Further, the connecting outlet 2 of the blood collection bag 3 is provided with a connecting tube 17 connected by a connecting needle 16 at the tip, and this connecting tube 17 is provided with the outlet 10 with a peel tab via a branch pipe 15 as described above. A first child bag 1 made of a soft resin composition and having a peripheral edge 11 similarly heat-sealed.
A connecting tube 13 made of the soft resin composition is connected to the internal space 12 of the soft resin composition 4, and these connecting tubes 17 and 13 are further provided with an outlet 18 with a peel tab via a branch pipe 15. A second child bag 2 made of a resin composition and having a peripheral edge 19 similarly heat-sealed
A connecting tube 22 made of the above-mentioned soft resin composition is connected to the internal space 20 of No. 3.

This dual blood bag is capable of separating the components of blood collected in a closed system. That is,
First, a predetermined amount of blood is collected from a puncture needle 8 inserted into a blood donor's vein through a blood collection tube 6 into a blood collection bag 3 . After blood collection is completed, the blood collection bag 3 is centrifuged to separate the blood into an upper layer of platelet-rich plasma and a lower layer of blood cells. Next, the platelet-rich plasma in the upper layer is pushed out from the blood collection bag 3 and passed through the connecting tubes 17 and 13 to the first child bag 1.
Transfer the platelet-rich plasma to Step 4. The first child leg 14 containing the platelet-rich plasma is further centrifuged to separate the platelet concentrate in the upper layer and the platelet-poor plasma in the lower layer, and the platelet concentrate in the upper layer is transferred to the first child leg 14. 14 and is transferred to the second child bag 23 through the connecting tubes 13 and 22. Blood collected in this way is separated into components by centrifugation and stored in each blood bag, so even if the blood components come into contact with the blood bags and tubes for a long time, each blood bag and tube will be separated as described above. The soft resin composition of the present invention, which constitutes the composition, has an excellent red blood cell protection effect and does not inhibit the aggregation ability of platelets, thus enabling safe and effective component transfusion.

The above explanation has been made using blood bags as an example, but the above also applies to other medical devices such as body fluid storage containers, catheters, blood transfusion sets, blood circuits, packaging containers for medical devices, packaging containers for drugs such as tablets, etc. The soft resin composition is suitably constituted by the following.

The medical device according to the present invention is sterilized before use, and ethylene oxide sterilization, autoclave sterilization, etc. are used as the sterilization method, and autoclave sterilization is preferably used. In autoclave sterilization, medical devices are typically treated at 121° C. for about 60 minutes, but as described above, the medical devices of the present invention have sufficient heat resistance to withstand such autoclave sterilization conditions. .

(Examples) Hereinafter, the present invention will be explained in more detail based on Examples.

Example 1 Pellets were prepared by blending 20 parts by weight of isopropyl isolaurate with 100 parts by weight of ethylene-vinyl acetate copolymer (manufactured by Mitsubishi Yuka Corporation, Yucalon EVA) using a vented twin-screw extruder. A sheet was made by extrusion molding using the pellets, and a 20 ml mini blood bag was made by overlapping two of the obtained sheets and high-frequency sealing at a predetermined portion. The bag was filled with human CPD-added concentrated red blood cell fluid (hereinafter C
It is called RC. ) Approximately 20 ml of the solution was dispensed and stored at 4°C for 3 weeks. Thereafter, the plasma hemoglobin concentration was measured using the TMB method (Clinical Chemistry Record 749-(1977)).
[Cl1n, Chem, 23749~(1977
)] )). The results are shown in Table 1.

Example 2 A mini blood bag was prepared in the same manner as in Example 1, except that 20 parts by weight of 2-ethylhexyl isostearate was blended with 100 parts by weight of ethylene-vinyl acetate copolymer (Mitsubishi Yuka Co., Ltd. Wooden, Yucalon EVA). were prepared and examined for changes in plasma hemoglobin concentration. The results are shown in Table 1.

Example 3 Ethylene-vinyl acetate copolymer (manufactured by Mitsubishi Yuka (1),
Yucalon EVA) 100 heavy weight 2-ethylhexyl-
A mini blood bag was prepared in the same manner as in Example 1, except that 20 parts by weight of 2-ethylhexanoate was added, and changes in plasma hemoglobin concentration were examined. The results are shown in Table 1.

Comparative Example 1 For comparison, a mini blood bag was prepared in the same manner as in Example 1 using only ethylene-vinyl acetate copolymer (Mitsubishi Yuka Co., Ltd. (now discontinued, Yucalon EVA)), and changes in plasma hemoglobin concentration were examined. The results are shown in Table 1.

Example 4 Polyurethane (
A mini blood bag was prepared in the same manner as in Example 1 except for using Dainippon Ink and Chemicals (Tai-Sei, Pandex),
Changes in plasma hemoglobin concentration were examined. The results are shown in Table 1.

Example 5 Polyurethane (
A mini blood bag was prepared in the same manner as in Example 2, except that a bag (manufactured by Dainippon Ink & Chemicals, Inc., Pandex) was used, and changes in plasma hemoglobin concentration were examined. The results are shown in Table 1.

Example 6 Polyurethane (
A mini-blood bag was prepared in the same manner as in Example 3, except that a bag (manufactured by Dainippon Ink & Chemicals, Inc., Pandex) was used, and changes in plasma hemoglobin concentration were examined. The results are shown in Table 1.

Comparative Example 2 For comparison, a mini blood bag was prepared using only polyurethane (manufactured by Dainippon Ink & Chemicals, Bandex) in the same manner as in Example 4, and changes in plasma hemoglobin concentration were examined. The results are shown in Table 1.

As is clear from the results shown in Table 1, when the soft snow opening composition according to the present invention is used (Examples 1 to 6), when nothing is added to the soft snow opening composition (comparison Example 1~
It can be seen that hemolysis is suppressed to a low level compared to 2).

Reference experiment A platelet functional recovery experiment was conducted using the following procedure.

First, add 200 isopropyl isolaurate to methanol.
00 pI) ill solution (Reference Example 1), 2-ethylhexyl isostearate 20000 in methanol
Di) m solution (Reference Example 2), 2-ethylhexyl-2-ethylhexanoate 200% in methanol
001)l)m solution (Reference Example 3), di-2-ethylhexyl phthalate 20000 p in methanol
A solution in which pm was dissolved (Control Example 1) and methanol to which nothing was added (blank) were prepared. Each of these solutions was added to human platelet-poor plasma at a rate of 1/100 i, and 2 tnl of this platelet-poor plasma was added to 1 ml of human platelet-rich plasma and further added to Tyrode's
solution (1 μM PEG, 4X10 units/ml
, avirase, 3°5■/ml BSA)
After addition, incubate at 37°C for 90 minutes. After this, the platelets are washed and the European
Journal of Biochemistry 142. 465
(1984) [Legrand et al.
ur, J, 13iochem, 142. 465
(1984) ] ), Tyrode [Tyrode/BSA solution (
0,2mM CaCΩ2.1mM MgCC2,5
Tyrode's solution containing mMHEPES, 3.5 mg/m1BsA.

Resuspend at pH 7.35 > 50 μM ADP and 10 μg/ml in the presence of 0.2μ/ml fibrinogen.
The maximum aggregation rate for ml collagen was measured using the Age Recorder (
The measurement was carried out using the Kyoto Daiichi Kagaku Co., Ltd.).

The results are shown in Table 2.

As shown in Table 2, di-2-ethylhexyl phthalate (Control Example 1) has an inhibitory effect on recovery of platelet aggregation ability. This suggests that di-2-ethylhexyl phthalate may inhibit platelet function when it enters the body, indicating that it is not appropriate to incorporate it into medical soft resin compositions. It is something. In contrast, isopropyl isolaurate (Reference Example 1
), 2-ethylhexyl isostearate (Reference Example 2)
and 2-ethylhexyl-2-ethylhexanoate (Reference Example 3), such an inhibitory effect is not observed, and it can be said that it is a safer counterfeit. Therefore, the soft resin composition according to the present invention It can be seen that the effect on platelets is also small.

(Effects of the Invention) As described above, the present invention provides a soft resin composition for medical use characterized in that a monocarboxylic acid ester represented by -maximum (I) is blended into a soft resin composition that does not contain a plasticizer. Because it is a resin composition, there is essentially no elution of the plasticizer, so it is extremely safe, and like the conventional soft vinyl chloride resin composition that uses di-2-ethylhexyl phthalate as a plasticizer, it is effective for red blood cell production. It has a hemolysis-inhibiting effect and is ideal as a material for medical devices, especially medical devices that come into contact with blood, such as blood storage containers. Furthermore, when the medical soft resin composition of the present invention contains 5 to 35% by weight of a monocarboxylic acid ester represented by general formula (1), or - at least one of R or R' in maximum (1) More preferably, the compound represented by general formula (I) is isopropyl isolaurate, inpropyl oleate, 2-ethylhexyl isostearate, which represents a medical soft resin composition having a branched structure. or 2-ethylhexyl-2-ethylhexanoate, in addition, the soft resin is urethane-vinyl chloride copolymer, vinyl acetate-vinyl chloride copolymer, ethylene-vinyl acetate-vinyl chloride copolymer, etc. internally plasticized vinyl chloride resin composition, polyethylene, thermoplastic polyester, polyurethane, ethylene-vinyl acetate copolymer, or a polymer blend of polyvinyl chloride and polyurethane, ethylene polymer or caprolactone polymer; , safety, hemolysis inhibitory effect, and other physical properties are further improved.

The present invention also provides a soft resin composition that does not contain a plasticizer.
- It is a medical device characterized by being substantially composed of a soft resin composition blended with a monocarboxylic acid ester represented by maximum (I), so it has excellent safety,
and exhibits a hemolysis-inhibiting effect on red blood cells,
In particular, even when the medical device is something that can come into contact with blood, such as a blood storage container, it can be said that it is an extremely excellent medical device without the risk of denaturing blood components. Furthermore, in the medical device of the present invention, when the soft resin composition substantially constituting the medical device contains 5 to 35% by weight of a monocarboxylic acid ester represented by general formula (I), This indicates a medical soft resin composition in which at least one of R and R' in (I) has a branched structure, and more preferably, the compound represented by general formula (I) is isopropylisolaurate. , isopropyl oleate, 2-ethylhexyl isostearate or 2-ethylhexyl-2=ethylhexanoate, in addition, the soft lightning resin is urethane-vinyl chloride copolymer, vinyl acetate-vinyl chloride copolymer and Internally plasticized vinyl chloride resin compositions such as ethylene-vinyl acetate-vinyl chloride copolymers, polyethylene, thermoplastic polyesters, polyurethanes, ethylene-vinyl acetate polymers, or polyvinyl chloride and polyurethanes, ethylene polymers, or caprolactone When it is a polymer blend with other polymers, it becomes a medical device that is superior in terms of safety, hemolysis-inhibiting effect, and other aspects such as heat resistance, transparency, and flexibility.

[Brief explanation of the drawing]

FIG. 1 is a front view showing an embodiment of the medical device of the present invention. 3...Blood collection bag, 6...Blood collection tube, 13.
17.22...Concatenated Sento-bu, 14...First child Bug, 23...Second child Bug.

Claims (14)

[Claims] (1) In a soft resin composition containing no plasticizer, the general formula (I) RCOOR' (I) (wherein R and R' are each a chain hydrocarbon group having 3 or more carbon atoms, and R The sum of the carbon numbers of and R' is 11
~30. ) A medical soft resin composition containing a monocarboxylic acid ester represented by: (2) The medical soft resin composition according to claim 1, which contains 5 to 35% by weight of a monocarboxylic acid ester represented by general formula (I). (3) The medical soft resin composition according to claim 1 or 2, wherein at least one of R or R' in general formula (I) has a branched structure. (4) The compound represented by the general formula (I) is isopropyl isolaurate, isopropyl oleate, 2-ethylhexyl isostearate or 2-ethylhexyl-2-ethylhexanoate, claims 1 to 10. The medical soft resin composition according to any one of Item 3. (5) Claims in which the soft resin is an internally plasticized vinyl chloride resin, polyester, polyurethane, ethylene-vinyl acetate copolymer, or a polymer blend of polyvinyl chloride and polyurethane, ethylene polymer, or caprolactone polymer. The medical soft resin composition according to any one of items 1 to 4. (6) Claim 5, wherein the internally plasticized vinyl chloride resin is a urethane-vinyl chloride copolymer, a vinyl acetate-vinyl chloride copolymer, or an ethylene-vinyl acetate-vinyl chloride copolymer. medical soft resin composition. (7) In a soft resin composition that does not contain a plasticizer, the general formula (
I) RCOOR'(I) (However, in the formula, R and R' are each a chain hydrocarbon group having 3 or more carbon atoms, and the sum of the carbon numbers of R and R' is 11
~30. ) A medical device characterized in that it is substantially composed of a soft resin composition containing a monocarboxylic acid ester represented by: (8) Claim 7, characterized in that it is substantially composed of a soft resin composition containing 5 to 35% by weight of a monocarboxylic acid ester represented by general formula (I). medical tools. (9) The medical device according to claim 7 or 8, wherein at least one of R and R' in general formula (I) has a branched structure. (10) Claims 7 to 7, wherein the compound represented by general formula (I) is isopropyl isolaurate, isopropyl oleate, 2-ethylhexyl isostearate, or 2-ethylhexyl-2-ethylhexanoate. The medical device according to any of Item 9. (11) The soft resin is an internally plasticized vinyl chloride resin composition, polyethylene, thermoplastic polyester, polyurethane, ethylene-vinyl acetate copolymer, or a polymer of polyvinyl chloride and polyurethane, ethylene polymer, or caprolactone polymer. The medical device according to any one of claims 7 to 10, which is a blend. (12) The internally plasticized vinyl chloride resin is a urethane-vinyl chloride copolymer, a vinyl acetate-vinyl chloride copolymer,
or the medical device according to claim 11, which is an ethylene-vinyl acetate-vinyl chloride copolymer. (13) The medical device according to any one of claims 7 to 12, which is a blood storage container. (14) The medical device according to any one of claims 7 to 13, which can withstand autoclave sterilization.