JPS5971760A - Medical tool - 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. Gyoda of invention Technical field The present invention (Jl, Medical Devices III-7).

To be more specific, Qli ell Tsuki during blood component preservation
This article relates to medical devices made of vinyl chloride resin with excellent J and II properties.

As is well known in the prior art, blood has a self-protective effect, and blood comes into contact with the Mino interface other than the inner wall of the blood vessel, platelet adhesion and aggregation to the Tatsumi interface, and plasma gluing. formation of fibrin crosslinks occurs. In conventional blood bags, platelets in the blood aggregate on the plastic interface of the blood bag, and 6 days after blood collection, the platelet aggregation function decreases to about 60% of the blood collection, and further increases to 27'1. After some time, it drops to about 40%. -h, From the point of view of effective use of current platelet preparations, storage containers ranging from Plus Deck that can store blood cells for longer periods of time to 4+: Press Deck, which has all four blood '/+k yu combinations. There is a desire for the development of a water-containing container or other medical devices consisting of -.

Currently, such plastic containers, IJs, and other medical tools are made of soft plasticized vinyl resin because of their good processability, flexibility, transparency, low water vapor permeability, heat resistance, etc. Blood bags are widely used. These soft vinyl chloride resins are referred to as di-2-col-hexyl phthalate-1 (hereinafter referred to as 1., 1) Op as a plasticizer. ) Contains 30-60% of snow notaric acid varnish11.

However, it is known that phthalate has a low migration property, so if a blood container is made using the soft vinyl chloride resin, for example, phthalate is known to be eluted into blood plasma. For this reason, 7-talate nisol is dissolved in the blood containing concentrated platelets.
J, it has been reported that it causes multiple decreases in the condensing ability of platelets (1).
2 (1982)).

- Polynisful plasticizers are used as non-transferable plasticizers. This polynisful plasticizer is generally a phthalate with a skeleton of 1-1-14, which has an odor such as water resistance, hydrolyzability, etc. Acid: "It is well known that it is better and worse.

■0 Purpose of the invention Therefore, the purpose of the present invention is to provide a medical device (,1% iJ).Another object of the invention is to provide a medical device with good biocompatibility. The purpose is to provide the lp.

The present invention further relates to 1-stage medical instruments such as a 4-stage blood storage container that can prevent plasticizer migration and has good water resistance, a blood circuit, etc. .

These terms are vinyl chloride resin, J, and the general formula [ (wherein, [< is the number of carbon atoms/remaining aliphatic saturated hydrocarbon having 1 to 18]), and t. The medical device is made of a resin composition consisting of a biferde] dicarbonate represented by , ).

In addition, according to the present invention [, 1, per 100 parts by weight of vinyl chloride resin, 1 part of bifj-nylte[-lacarboxylic acid 1-ara] [sj of 20 to 120 small fP] represented by the general formula I is added. In the medical device (9), the present invention further provides the following:
General formula I'U with respect to 100 parts by weight of vinyl chloride resin
- Pinotinyl 7-1 helacarboxylic acid tetraT expressed
This is a medical Kawaguchi product containing 30 to 100 weight u1 part of Sual. The present invention is a medical device in which R is a fat containing 8 to 18 atoms of 1 element, 1 J, and 1 water residue.

Further, the present invention is a medical device in which R is an aliphatic hydrocarbon residue having from 1 to 2 carbon atoms. Furthermore, the present invention provides that tetranisal of Nil-jl-lacarboxylic acid has the general formula J
1 (wherein, R is l) [as described in 1. ) 3,3',4.4=-Pino'-Nilft-Lacarboxylic Acid/'1-LaTsual C This is a certain medical device. Further, the present invention provides biphenyl-tracarboxylic acid>' l=
2, 3.3'', 4'-hy'f]-nyl) tracarbone of the present invention ( , L, body fluid storage container (1), which is a medical device (5).

The present invention is suitable for medical use where the body fluid is blood [! It is. Also,
The present invention is a medical device which is a blood supply, a blood transfusion retard, an infusion human or blood circuit.

■． DETAILED DESCRIPTION OF THE INVENTION The medical devices according to the present invention include a body such as a blood bag, a cuff, a blood transfusion cap, a blood transfusion container, and a blood circuit. , preferably a body fluid storage container, especially a blood bag.

In the present invention, the vinyl chloride resin used in the resin composition used to make the utensils includes polyvinylidene chloride and vinyl chloride at a concentration of 50%. Henceforth. and preferably 60% by weight or more, most preferably 90% by weight or more of other copolymerized 1'l.
There is a co-minor combination with Ili fi1 body, etc., and the average degree of small scale of (1700 to 3,000, preferably 1,
000 to 2,700. Comonomers for vinyl chloride include vinyl chloride, ethylene, propylene, vinyl acetate, beer bromide, vinyl nitride, styrene, beer pyridine, acrylic acid, and alcohol. -1 Rufunokryle-1- (141 For example, Methyl Funokryle 1-, 2 [Puruaku January Notes, Isop [1
Pill hook acrylate, 11-bubble acrylate-1, 2
-] pull to A-dyl acrylate-1, etc.), methacrylic acid,
Nonol: to 1-l methacrylate-1, (for example, methyl methacrylate-1-1~.

Tdel-methacrylate-1-,2-ethylhenyl-1: silmethacrylic 1 note, etc.), acrylic [1 nitrile, methacrylic acid-1] to rilukasa. In addition, a non-)methacryloni]nitrile copolymer for submers, and a chlorine-methacryloni-1-lyl copolymer can be blended with the vinyl chloride resin.

The plasticizer and the pinotyl T1-lanonorponic acid)-traester used in () are those represented by the above general formula I, and are 20 to 120 parts by weight based on 100 parts by weight of vinyl chloride resin.
It is used for a mid-hung part, preferably 30 to 100 F8 parts. R in the general formula (2) is an aliphatic saturated hydrocarbon residue having 4 to 18 carbon atoms, preferably /1 to 12 carbon atoms, and most preferably 8 to 12 carbon atoms. This aliphatic saturated hydrocarbon residue IJ1 may be a straight-chain hydrocarbon group, and may be a hydrocarbon group with b, J, or other branches on the right.

The compound of the general formula r is represented by 3.
3′,4.4′″-bif[nyl-J[·racarboxylic acid 7
1~Lagosflu, also (J the general formula ■c shown 2,
3.3=,4-H) Upper-rude 1 to Lacarboxylic acid-1
~U° “The sprue is flowing.

3.3 = , 4.4''-biphenyltetracarboxylic acid 3,3 '' , /1,4 '' -di〕] L-ruatonecarboxylic acid '71 (n-J cube) 1- Methyl.3.
3-, 4.4'-biphenyl i1-racarboxylic acid te[・U(2-1-delhe1sil)nisdel, 3.3-
,4.4--Binoenylte-1hencarboxylic acid 1
~(2-Methylhepdyl) Nisder, 3.3', 4.
4' ~ biphenyllev 1-lacarboxylic acid-jtonk 1
1-nor) Nisdel, 3.3-, 4.4'-Bif I
Nilf = 1 = fucarboxylic acid 7 tora(1), decyl)
l'. 7. 5 ru, 3.3-, 4.4-
-Bif J Nilde 1~Lacarboxylic acid-jto・U(11
- undecyl) varnish) 2ru.

3,3-,/1.4-pino-1-lumi-1-lacarboxylic acid atla<1]-doa'sil)nisal, 3.3",
4.4'-bifuryl j1 ~ cyclonic acid a1 hera (1
1-tetradecyl) ester, 3.3", 4.4
'-Loquat 1 Nirua 1-F Carvone h2 71 Hen (1
1-pentadecyl) 2U sprue.

3,3′,4.4”-pino[nyl°11-lacarboxylic acidj1-la(11-heptadecyl)conimethyl, 3
．． 3=,4.4'-biphenyl-7'1-lacarboxylic acid j1-la(n heptadecyl) ester, 3.
3'4.4=-Pino 1. Nilde 1-lacarboxylic acid de[・
Examples include U(l+-;4tadecyl)nisal.

One example of 2,3,3',4-biphenyltetracarboxylic acid represented by the general formula (■) is 2,3,3',4-biphenyltetracarboxylic acid ．． 7′ To・U(11−Δcutyl)■Suter, 2
, 3.3'-, 4'-Bif-J Nylteonecarvone M:r I-'/(2-2F-Prhexyl) Nisdel, 2,3.3'', 4'-Bif-F-Nyl-J
1~fucarboxylic acid 7tra(2 mebool hebble) Nisdel, 2,3.3',4--pino''--runolyl 1-racarboxylic acid atoph(1]-nonyl)-1styl,
2,3.3'-,4'-bifu-nitricarboxylic acid atracarboxylic acid 11-decyl)-[sulfur,
2,3.3-,4--N-undecyl J1-Lacarboxylic acid A1-(n-undecyl)' Nisal.

2,3.3',4'-bifur-L-11-lacarboxylic acid'jf-la(n-1 niacyl) ester, 2,
3.3' 4-biphinyltetophcarboxylic acid atra(nt-lysosyl)nisder, 2,3.3=
, 4=-biphenyltetracarboxylic acid-a[・U(1)
-tetradecyl) ester.

2,3.3'', 4=-biphenyltetracarboxylic acid tetra(11-pentadecyl) ester, 2,3.3
-, 4”- Bifu L Nilfton Carbon Shun Detra (n-
Hexade'cil)'J. ．． Stell, 2,3.3-
, 4'-biphenyltetracarboxylic acid tetra(11-heptadecyl) ester, 2,3.3',4-biphenyltetracarboxylic acid 71-(n-;4tadecyl)Nisdel, and the like.

In order to produce the tetraesters represented by the above general formula (2), for example, a corresponding aliphatic alcohol such as pia-1-nylte-1-lacarboxylic acid or its dianhydride is mixed with an organic solvent, e.g. -Xylene.

o<1: in silene, llerj xylene, benzene, toluene, Schiff [J-1-san, 11-hebutane, etc.) or in the absence of a Nisderification catalyst, e.g. dithane-y1-rhabdoxide, In the presence of sulfonic acid, liil! acid, phosphoric acid, phosphoric acid ester, etc., 1 J of pt-luenesulfonic acid was reacted at a reaction temperature of 170 to 250°C for 5 to 100 hours. , there is a way to do it.

The resin composition made of vinyl chloride resin and a plasticizer is blended with metal soaps/υ containing metals such as calcium and zinc and subuaric acid, lauric acid, ricinoleic acid, sulfuric acid, etc. 1.

In addition, if necessary, epoxidized animal and vegetable oils such as J, lycopoxidized human X7 oil, and epoxidized linseed oil, lubricants, and antioxidants (1) and (H) are blended.

Next, while referring to the drawing, take the blood collection bag as an example.
The medical device according to the present invention will now be described.

However, since it is difficult to show the blood bag in the drawing, a plurality of beer tub outlet ports 1, d3, and II exits (12) (the blood collection bag 2 made of a vinyl chloride resin composition) is A blood collection duplex 6 made of a vinyl resin composition is heat-sealed by heating or other heating means and communicates with the internal space 5 of the blood collection bag.
are connected. The internal space of this blood collection bag contains 80 D-Δ solution as an anticoagulant (for example, 100 mL of an aqueous solution).
1 in sodium citrate 220 (1, citric f11i
0.80 (contains I and glucose 2.2 oa), CPD
liquid (e.g. 1 citric acid in 100 ml of aqueous solution) 1206
mg, sodium citrate 1.66! ], disodium phosphate 1/10 m (1° de 1-se) ~ loin 1.46 (
+ Contains) etc. are stored. Further, a blood sampling needle 7 is attached to the tip of the blood sampling tube 6. A cap 8 is attached (pulled) to this blood collection fLI7.

In addition, when connecting and covering a child bag in addition to the blood collection bag 3, a drain bag with a beer tab 19 made of a vinyl chloride resin composition is similarly heat-sealed at the peripheral edge 10, and the internal space 11 is A first bag 13 with a connecting pipe 12 made of a vinyl chloride resin composition is connected to a connecting outlet D2 of the blood collection bag 3 via a branch pipe 1/l.
Connecting duplex 1 (3) connected by connecting side 15 at the tip
is connected with. Further, a child bag 22 is provided with a discharge port 17 with a beer tab, and a connection valve 21 made of a vinyl chloride resin composition that is tightly connected to the peripheral edge 18 and communicates with the internal space 19 of the bag 22; j-121 is branch pipe 1/
I) is connected to W-section Cove 12.1G.

The above is explained using blood bags as an example.
It can also be used in the same way for Kaadel, blood circuits, and dialysis cheese.

Next, the present invention will be explained in more detail by giving examples.
It's bright.

Example 1 1/! , no-: one [3.3', 4.4-
-Biphenyl 11-racarboxylic acid anhydride 88.2g
(0,3 sil), 2-1 linol C325g
('L, 8■-L), nofluminium oxide 1.98 (
Supplying 15 J of Ii, and 0.2 J of prI-hydroxide,
Reaction time: U 1 E The reaction was carried out at 30 to 200° C. for 4 hours.

After the reaction was completed, excess 2-[dylhekylinol was recovered I) by distillation under reduced pressure. Rinse thoroughly, wash with dilute aqueous alkaline solution J>J and water, and finally distill under reduced pressure. 3.
3-. 4.4′″-vino-kingyl-tracarboxylic acid-11
~'7 (2-1-Del: 1-Sil)'1-Sual 24
2.9 (+ was obtained.

This T souffle has an Ii'il refractive index of 11♂ of 1.719.
3. The specific gravity d20 is 0.9E3ε3, and 1g of sterilization is 276 and d20.

This J, sea urchin [50 parts by weight of synthesized plasticizer, polyj!
Vinyl chloride (degree of polymerization 1,100), 1 part of epoxidized dog oil 3 layers, sj7' calcium phosphate d5 J, bis7 phosphoric acid! rI! Lead 1ill:f! 111 part J
The resulting resin composition was thoroughly kneaded in a two-day mold at a temperature of 150 DEG C. and formed into a sheet having a thickness of 0 DEG and 4111 m.

The 100% modulus of this sea 1 ~ type is 78°5k
g/cm2. In addition, the test of this sheet-like material
'I soaked in the liquid of the scale Noah for a specified time)? i did it, 70
Before dipping the strip, cover it with a dry cloth for 10 hours at 100°C. Table 1 shows the amount of plasticizer eluted after 81M. moreover,
When Test C was dried at 100° C. for 120 hours, the loss by volatilization was 0.03%.

Finally, the results of the elution test conducted in accordance with the method of [1, Wood Book Bureau h [Plastic Container Testing Method for Infusions JB, -302 to 318] were as shown in Table 2.

Furthermore, the product f ([Test results (31) were as shown in Table 1.

Example 2 Example 1 Mr. 111j<K h 7)s ”' M)
Notification 3, J'+4',4'-bif]-nyljtracarboxylic acid 1-ara(11-dodecyl)-r 50 small parts, polyJfif-formed beer, Ru (polymerization 1) page 1
, 700>, epoxidized oil 3rd edition ω part, s) monophosphate nickel d3 J, biszinc phosphate 1 medium hanging part, 2 wood 1]-le resin composition By 1 E
The mixture was kneaded at a temperature of 0° C. and formed into a sheet with a thickness of 0.4 mm.

This sheet 1 to 1 was subjected to the same tests as in Example 1, and the change was significantly different (according to Table 1; The results of the dissolution test, I5i property test, and physical property test were as shown in Table 2.1/I.

Example 3 Manufactured in the same manner as Example 1 1) Igo 2, 3, 3', 4
'-Bif J, Nilde 1-racarboxylic acid tethyl (2-ethylh1-yl) r Lucium and stearic acid! [Ii 1
) 1 part by weight J, two resin compositions were thoroughly kneaded in a 150°C oven using two bottles of E'] to a thickness of 0.4 ml.
+ was molded into a sheet-like material.

When this sheet-like material was subjected to the same test as in Example 1, the amount of change in weight (h) was as shown in Table 1, and the weight loss by volatilization was 0.0.
It was 4%. , "The results of the dissolution test, toxicity test, and substance tyt test are shown in Tables 2 to 4, respectively.
It was ri. 1 Example 4 2, 3.3-. 4-
50 parts by weight of 1-vino-1-nyl-11-hexycarboxylic acid (11-dodecyl)
Polymerization degree '1,100), epoxidized soybean oil 3Φ hanging part i
Calcium phosphate J, bisalanophosphoric acid i%N
From the car suspension part, the 2Z 8 tree 1117 composition was kneaded well with a 2 tree roll at a temperature of 150°C, and the thickness was Q, 4n+.
Form into a sheet of m and l, :,.

This sheet-like material was subjected to the same test as in Example 1-1, and the weight change m was m1 as shown in Table J3, and the volatilization loss was 0.02% after vehicle suspension. In addition, the results of the dissolution test, toxicity test, and physical property test are as shown in Table 2.4.

Comparative Example 1 J3 was prepared in the same manner as in Example 1, except that G2-1 Nidylhexylphthalate 1 was used instead of Atoni 1 Souffle. It was formed into a sheet.

When this sheet-like material was subjected to the same test as in Example 1, the weight change (m) was as shown in Table 1, and the volatilization loss (m) was 3.7% by weight. In addition, the results of the dissolution test, city P1 test J3, and physical property test were as shown in Tables 2 to 1, respectively.

Comparative Example 2 In the same 1!4T method as in Example 1, 2.2-biphenyldicarboxylic acid di(2-[-
The same method was carried out except that Derhexyl) I Sual was used to form a sheet 1- shape with a thickness of 0.04 mm+.

When this sheet-like material was subjected to the same test as in Example 1, the 10 single change suspension was as shown in Table 1, and the volatilization reduction W was 2.5.
Atsushi with heavy ID%. The results of the dissolution test, toxicity test, and physical property test are as shown in Tables 2 to 1, respectively.

Comparative Example 3 In the same manner as in Example 1, -7' t = Usual (kobicyclo(2,2,2) Acuteau 1-
Gonin-2,3,5,6-:7 l~lacarboxylic acid ゛1
A sheet of 0.4 mm thick was molded into a personal item using the same method except that -1-ra (2-nibble to 1:sil) varnish was used.

This sheet-like material was subjected to the same test as in Example 1 using fJI.

As a result, as shown in Table 1, the weight change 11 was the volatilization loss (mass/1.2 Fl hanging%).
↑Result number of 1 test and physical property test, respectively ff12
~4 It was as shown in Table.

Example F5 △CD-Eight fluid (3 volumes) Blood was collected from a human vein surface using a glass syringe containing 40 volumes suspended and centrifuged (160G, 1 volume).
0 minutes) causes platelet-rich blood 1! (PRP) was obtained. 2 ml of this PRI] in Examples 1 to 4 and Comparative Example 1.
The contents were aseptically dispensed into mini bags made from the sheet-like material obtained in 3. Considering individual differences in blood, -3 each
lζ using sample blood. The platelet aggregation ability test for [Rl] used the aggregation ability test of PRP stored in a bag at room temperature for 2, 6 and 24 hours.

Equipment used; Δggremeter AUT
ORA M-11 (manufactured by Rika Denki Kogyo Co., Ltd.) i111 constant temperature: 37°C 1-cycle stirring speed: 1ooorpn+ test "J8: △DP final 1II 11 degrees 10-5M reagent resistance: PRP/reagent-10./1 bag min. The maximum aggregation rate in the notes is A+, the maximum aggregation rate at each time is A2, 80, Δ24, and Δ2/AI.

Average ratio of 3 samples with 8 values of Δ6/Δ1 and A24/AI (A2/A+), (A67'Δ1)
and M(Δ2+/A6). The measurement result was C as shown in Table 5.

■6 Specific effects of the invention As mentioned above, the cooling equipment according to the present invention has JAi
f-vinyl vinyl resin and Pino represented by the general formula (2).

Since it is made of a resin composition consisting of nilf'1 to lacarboxylic acid tranisfur, extraction of the plasticizer 1
4 has been conventionally used.It has an extremely low level of U1/20 compared to silt talate, etc., and its volatility is 23 times lower, and its migration to the surface is also low. , +tCt Note V7f, even if the patient comes into contact with body fluids such as blood, the problem of decreased aggregation ability of platelets caused by the elution of the plasticizer into the plasma will be significantly revised.In particular, In the platelet aggregation test, the low F skewer is significantly smaller than the conventional C1 product, so the storage space can be significantly extended.
τ・sak〉.

In addition, for the vinyl chloride resin 10]i hanging part C5 two pairs of bifurcated carboxylic acids represented by the general formula I, the blending amount of methyl was 20.~120 parts M, 30.~1
If you spell it as 00 parts by weight, you will lose the advantages mentioned in O11.4
It can exhibit various physical properties. Therefore, it is necessary to use 4iH containers for body fluids such as plasma blood storage containers, cuffs, blood transfusions, infusion receptacles, blood circuits, etc., especially when there is direct contact with body fluids or in the body. JA used for medical equipment that comes into contact with the chemical solution supplied to the
It exhibits excellent effects when used.

In addition, the force j'-・il (b used in the blood circuit: l!
When used for a long period of time, the elution of plasticizer is extremely small like the 1ζ product. This eliminates the troubles that were caused by the removal of one original.

[Brief explanation of the drawing]

The drawing is a front view of an example of the medical device according to the present invention. . 3...Blood bag, 13.22...Rice bag,
6.16.21...B-B Q"I'if'l Applicant Al
(vii) stock company agent;
Patent attorney 8 ITJ 9? Male Procedural Decree 11 Official Book December 10, 1980 Commissioner of the Patent Office Name: Kazuo Sugi 1. Indication of Item 1. 1981 Special Amendment Application No. 181.481 2. Name of Invention Medical Device 3. Amendment. Zuru Meijin (Relationship with T Patent applicant Shibuyaku Hatagaya Address 2-44-1 Hatagaya, Shibuya-ku, Tokyo
Name: Dell Seven Co., Ltd. Mitsuo Tozawa Representative Director: Mitsuo Tozawa 4, Agent address: Dia Palace Nibancho, 11-9 Nibancho, Chiyoda-ku, Tokyo Voluntary amendment 6, Subject of amendment (1) ll river use 1p) Pure (no change in content) (2
) Drawing 7, contents of amendment - (1) Exuded attached sheet attached fJ specification and d3 (2) Drawing

Claims (1)

[Scope of Claims] (1) Vinyl chloride resins and general compounds (wherein R is other than an aliphatic saturated hydrocarbon having 4 to 18 carbon atoms), t. ) A medical device made of a resin composition consisting of tetranystere biphenylatracarboxylic acid represented by: (2) The range claimed in patent n1li described in No. 1 Jjl, wherein the blending amount of the phenyltetracarboxylic acid te[-la]nisder represented by the general formula I per 10011 parts of the vinyl chloride resin is 20 to 12 ha 1 part. medical equipment.・(3) General formula I'C'' 4 times phenyltetracarboxylic acid tetranis''j based on 100 parts by weight of the vinyl chloride resin composition
2. The medical device according to claim 2, wherein the amount of the compound is 30 to 100. (4) R is an aliphatic saturated hydrocarbon residue having 4 to 12 carbon atoms; [8'] The medical device according to any one of claims 111 to 3. (5) R is an aliphatic saturated hydrocarbon residue having 8 to 12 carbon atoms; q! j. The medical device according to any one of claims 1 to 4. (6) Bifu: Natsudinyldetracarboxylic acid tetraTsual is 3,3',4,4'-biphenyl represented by the general formula The medical device according to any one of claims 1 to 3, which is a latracarboxylic acid ester. (7) Bif I nil j torano J rubonic acid °i torayu, sui
[, above, general formula ■ 1 0 (wherein, R is as described above). ) 2,3.3=,4--pino]nylatracarboxylic acid Te1-Raethyl represented by Claims 1 to 3
The medical device according to any one of claims 1 to 7. No. 1, medical equipment. Khu) Body fluid is blood, especially within the range of 1 year old!'!Medical equipment described in item 8. (10) Medical equipment is q:''Iy'r
1> as set forth in any one of claims 1 to 7, for medical use. (11) Iriζ#r, 1 Kawagu (It's a blood transfusion set!l
:j, 5'f A one-seat medical device according to any one of claims 1 to i7. (12) The medical device according to any one of claims 1 to 7, wherein the medical device is an infusion liquid 1.
. (13) The medical device according to any one of items 1 to 7, which refers to the blood circuit.