HU214462B - Collector tube for taking of blood - Google Patents

Abstract

The aspirated collector tube according to the invention is designed for blood collection, the collector tube being open at one end and the other end cap; at the end of the collecting tube, a sealing closure is provided inside the collector tube to hold a collapsible end closure; . The amylamide propylene blend containing the xylylene propellers is an oxide of methylene chloride. The material of the collecting tube also contains blue or leather red dye. ŕ

Description

SUMMARY OF THE INVENTION The present invention relates to a suction collecting tube for blood sampling. The collector tube, or more particularly an airtight tubular container used for blood collection, has a slightly reduced vacuum inside it, which means that the internal pressure of the suction collector barely changes during storage.

The aspirated collection tube used for blood sampling is used to perform test tests and measurements such as. biochemical, serological, hematological, blood glucose, coagulation test, blood count and bacteriological tests. The blood collection tube is usually a tube open at one end and closed at the other end with a rubber stopper at the open end. A rubber-sealed collector tube at one end and a sealed bottom at the other end are pumped out before use. The internal pressure of the pre-aspirated manifold is such that it can collect the required amount of blood (2-20 ml) while maintaining a sufficient vacuum.

Until now, the manifold sealed at one end and aspirated for the reasons described is made of glass. Glass produced by high speed centrifugation or the like is fragile during treatment and is therefore more recently replaced with synthetic resin.

Synthetic synthetic resin is selected from polyester, polyethylene, polypropylene and the like for the blood thinner collecting tube. Polyester is generally used because polyester is a more preferred material than polyethylene. Polypropylene or the like is gas-tight and impervious to gas. Because oxygen and nitrogen leak through the wall of the polyester manifold, the gas barrier of the polyester is of lower quality than glass. Therefore, the vacuum is difficult to maintain during long-term storage in a polyester manifold. The synthetic resin currently used and aspirated for blood sampling has a lower gas barrier than a glass blood collection tube. For the reason mentioned in the study of the container material, the aspirated collecting tube used for blood sampling is made of synthetic resin. For example, a collection tube pumped for blood sampling is stored empty with special gas.

SUMMARY OF THE INVENTION It is an object of the present invention to provide a blood collection tube drawn from a synthetic resin, which has an excellent gas tightness. The vacuum inside the depleted blood collection tube of the present invention is maintained for a long time until use.

These and other objects of the invention will become apparent from the following description.

The pumped blood reservoir of the present invention is an open end at one end and a closed end at the other end. The tube comprises from 99.5 to 92% by weight of polyethylene terephthalate, from 0.5 to 8% by weight of polyamide having m-xylene groups and from 1 to 100 ppm of transition metal on said polyethylene terephthalate and polyamide having m-xylene groups. A stopper is provided to maintain the internal vacuum of the manifold.

The suction manifold aspirated according to the aforementioned purpose may be implemented as described in the present invention.

The suction blood collection tube of the present invention will be described in more detail below.

The term "closure" as used in the present invention refers to a closure portion that fits on the open end of a drawn blood collection tube. An open-ended manifold sealed with a closure element retains its internal pressure. The closure can be pierced with a blood collection needle. When using the suction blood collection tube of the invention, one end of the blood collection needle is inserted into the vein and the other end of the needle is inserted through the closure into the suction collection tube. The vacuum draws blood through the needle into the pumped down collecting tube. In practice, the closure member is a rubber disk made of elastic material that can be removed and a new one fixed; the closure provides gas tightness and sealing and so on.

The term "open end at one end and closed end at the other end" as used herein refers to a tube that can be used as a suction blood collection tube. For example, a tube sealed at one end is a tube having an outer diameter (0) of 10-16 mm, a length of 60-170 mm, a wall thickness of 1-2 mm and so on.

The polyethylene terephthalate of the present invention is a widely used polyester which may be prepared from terephthalic acid or its ester (in particular dimethyl terephthalate) reacted with ethylene glycol. The above polyethylene terephthalate contains not less than 80% by weight of ethylene terephthalate in a repeating unit. The copolymerized components in the example are e.g. isophthalic acid, naphthalene dicarboxylic acid, p-oxybenzoic acid derivative; butanediol and so on.

In the injection molding process, it is preferred that said polymer of the polyester has a molecular weight ranging from 0.6 to 0.9 and an intrinsic viscosity [η] resulting in a suitably closed end tube. The viscosity was dissolved in 100 ml of a three-component mixture, three parts by weight of phenol and two parts by weight of 1,1,2,2-tetrachloroethane, dissolved in 0.25 g of polymer, measured at 25 ° C. The m-xylene group polymer used in the present invention has at least one diamine as the amine component selected from the group consisting of a mixture of (1) m-xylylenediamine and (2) m-xylylenediamine and p-xylylenediamine and (3) Who; and the acid component is at least one carboxylic acid selected from the group consisting of adipic, pimelic, cork, azelaic and sebacic acids. According to the invention, it is convenient to use poly-m-xylylene adipic acid diamide as the polyamide of the m-xylene group. The polyamide containing the m-xylene of the present invention plays a role in improving the gas-tightness of the closed-ended manifold.

The transition metal used in accordance with the invention is cobalt, nickel, radium and so on. The transition metal of the present invention is used in the form of a salt. The transition metal salts used in the present invention include, for example, cobalt acetate, cobalt naphthenate, cobalt stearate, nickel diacetylmethane, nickel chloride, radium chloride and the like.

The present invention relates to a manifold made of a mixture of a polyamide and a transition metal salt containing a m-xylene group which absorbs oxygen gas.

The material of the blood collection tube sealed at one end of the invention is a mixture of a transition metal salt, a polyamide having m-xylene groups and polyethylene terephthalate. Injection molding of the three components can be done in one step. Injection of the three-component mixture

Before starting, the three components can be mixed in several ways.

Since the closed-end collecting tube of the present invention is injection-molded from a mixture of polyamide containing m-xylene, the final product may be yellow. The color of such a yellow product can be rendered colorless by appropriate compensation of the molecular structure of the three constituents. When using granules based on polyethylene terephthalate containing up to 4% by weight of a blue or purple pigment in a ternary mixture of the test tablet, the yellow color of the product is barely noticeable. Polyethylene terephthalate was used in the form of granules. In the granulate, e.g. 1% by weight of pigment. The granules containing the blue or purple pigment are preferably added to the polyamide containing the m-xylene group in the same amount of mixture. The pigments used according to the invention are e.g. Blue 1 (C 142090), Blue 2 (CI 73015), Blue 201 (CI 73000), Blue 202 (CI 42052), Blue 203 (C 142052), Blue 204 ( CI 69825), Blue 403, Magenta 201 (CI 60725) or other similar pigments.

From the polyamide containing the m-xylene group, the present invention provides a manifold made from a prepared mixture of widely used polyester and metal salts, which provides the sealed tube with excellent gas tightness and oxygen trapping. It is noteworthy that the transition metal salts accelerate these properties as catalysts.

The blood collection tube of the present invention is made of a synthetic resin which has excellent gas-tightness and, as described above, also binds oxygen, and can maintain the vacuum of the drawn blood collection tube for a long time before use.

According to the invention, it is necessary that the mixture described contain from 99.5 to 92% by weight of polyethylene terephthalate, preferably from 99 to 96% by weight, and from 0.5 to 8% by weight, preferably from 1 to 4% by weight, of polyamide having a m-xylene content. If the ratio of m-xylene to polyamide is more than 8% by weight, the transparency is degraded and the tube material becomes expensive. On the other hand, if the proportion of polyamide containing m-xylene is less than 0.5% by weight, the oxygen scavenging capacity is impaired.

According to the invention there is a need for a transition metal in the amount of 1-100 ppm, preferably in the range of 2 to 50 pmm, in the form of a metal salt. If the metal salt content is more than 100 ppm, the collecting tube will become colored, its transparency will be degraded, and the material of the tube will become expensive. On the other hand, if the transition metal salt content is less than 1 ppm, the catalytic effect of accelerating oxygen binding is impaired.

The closed end collecting tube made of the polymer of the present invention may also contain a beneficial additive (s), e.g. anti-aging additive, ultraviolet curing agent, extrusion aid, and polymerization enhancer, etc.

The invention will be described in more detail below, unless otherwise specifically indicated, by weight percentages, by way of example and comparative test results, test assays.

Obviously, the invention is not limited to the examples, comparative test results or test trials and, notwithstanding the spirit and scope of the invention, various changes and modifications are possible.

1-10. and Tests 1-3. Comparative Test Results

Table 1 illustrates the use of the substance (s) described herein. The 5 ml blood tube, closed at one end and opened at the other end, has an inside diameter of 10.8 mm, a length of 75 mm and a wall thickness of 1.3 mm. The manifold thus formed was sealed with a butyl rubber closure.

Ten manifolds were prepared in each group.

Table 1

Test viszqálat number polyester / m-xylene containing polyamide / blue granulate containing pigment Cobalt concentration Ippnl 1 1OO / 1 / O 23 2 1OO / 1 / O 5 3 1OO / 1/2 5 4 1OO / 2 / O 10 5 100/2/0 5 She 100/2/0 1 7 100/4/0 1OO 8 1OO / 4 / O 20 9 100/4/0 10 10 100/4/0 2 * 1 1OO / O / O 0 2 * 100/0/0 0 * 3 100/0/2 0

Table 2

Test storage days at 50 'C

number timing kezdezén 3 weeks 6 later on 9 nyomástar 12 rate 15 ^ in 1 100 110.2 122.7 124.9 125.8 127.9 2 100 102.2 104, p 106, 5 112, p 114.4 3 100 101.4 103.0 106, 8 109.0 112.2 4 100 107, 1 116, 3 121.2 123, 5 124.9 5 100 102.8 107.1 114.1 116, 5 118.0 6 100 97, 4 95.6 95.0 94, 5 93.3 7 100 120, 5 126.3 127.0 127.3 126.6 8 100 109.8 122.2 124.9 127.2 129.7 9 100 108, 3 118.6 122.4 124.8 126.3 10 100 97, 5 97.0 96, 8 96.0 96.0 1 - 100 96, 5 94.8 93, 5 92.2 90.8 2 * 100 96.8 95.6 95.4 95.0 94.6 * 3 100 96.3 94.5 93, 6 92.7 91.4

* comparative tests

HU 214 462 Β

The polyethylene terephthalate used as polyester, poly-m-xylylene dipindiamide (adipic acid diamide) and anthraquinone, which is considered as the coloring agent, and the polyamide of the m-xylene group and the blue pigment, are shown in Table 1.

Test 1

The internal pressures of ten manifolds were examined in each group.

During Testing 1-10 and Comparative Testing Testing 1-3, there was a pressure of 460 torr (300 mmHg = 760-460 torr absolute) inside the blood collection tube.

The internal pressure of each aspirated manifold was measured at 50 ° C at the start of the measurement and every 3 weeks, 3-6-9-12-15 weeks. The pressure hold ratio calculated from the measured vacuum value was 100% at the start of the time measurement. The results are summarized in Table 2.

Test 2

Similar to Test 1, the internal pressure of each collection tube aspirated for blood sampling was reduced to a relative pressure of 310 torr (450 mm Hg).

The pressure hold ratio calculated from the measured vacuum value was 100% at the start of the time measurement. The results are summarized in Table 3.

Table 3

Test storage days at 50 * C Number of timings 3 6 9 12 15 kezdezén a week later the pressure was maintained rate in%

1 100 104.5 108.5 109.1 109.3 109. 5 2 100 101.0 101.8 102.8 103.5 103, 6 3 100 101.2 102.0 102.8 103.5 103.9 4 100 103.0 104.7 106.6 107.6 108.0 5 100 101.3 102.4 103.6 105, 5 106.3 6 100 96.4 95.8 95.0 93, 8 92.7 7 100 109.5 110.6 110.8 110, 3 109.7 3 100 104.4 108.8 109.7 110.2 109.8 9 100 103.5 107, 9 108.9 109, D 108.9 10 100 97.0 96. 6 96.5 95, 7 94.8 * 1 100 95.4 93, 7 90.6 88.0 86.4 2 * 100 95.8 94, 0 93.2 92.5 91.6 3 » 100 95, 5 93, 9 91.4 90.0 88, 5

♦ Comparative studies

Test 3

Similar to Test 1, the internal pressure of each collection tube aspirated for blood sampling was reduced to a relative pressure of 30 torr (730 mmHg).

The pressure hold ratio calculated from the measured vacuum value was 100% at the start of the time measurement. The results are summarized in Table 4.

1-3. during the test studies, a monitoring time of 15 weeks at room temperature slightly above 50 ° C was used.

Table 4

Test storage days at 50 ° C Number timing 3 6 9 12 15 kezdezén a week later the degree of pressure retention %-in

1 100 98, 5 98.0 97.5 96.2 95.6 2 100 97.0 96.5 96.5 96, 1 95, 4 3 100 97, 2 96.8 96.4 95.9 95.2 4 100 97.9 97.6 96.7 96.2 95.7 5 100 97.0 96.5 96, 3 96.1 95.3 6 100 96, 5 93.5 92.3 91.1 89.9 7 100 99.0 98.0 97.5 96.8 95.9 8 100 98, 7 97.7 97.1 96.6 95.7 9 100 98, 2 97.8 97.2 96.2 95.8 10 100 96, 7 94, 1 93.5 91.8 90.5 * 1 100 95.0 93, 5 90.3 88.4 85.3 2 * 100 96.0 93.8 92.0 90, 5 88.6 3 » 100 95, 2 93.8 90.5 89, 0 86, 8

♦ Comparative studies

A 2-4 ·. The results presented in Tables 1 to 4 show that more oxygen is bound at higher cobalt composition. In addition, polyamide containing higher amounts of m-xylene groups exhibits faster oxygen absorption.

2-4. There is a difference between the results summarized in the tables. The amount of oxygen absorbed varies depending on the degree of vacuum. That is, the more the collection tube is drawn off for blood collection, the lower the amount of oxygen in the collection tube.

The manifold of the present invention uses a blue pigment and has no influence on this gas barrier. In addition, the ingredients used in the Examples and Comparative Test Results and Test Trials may be used in other formulations to achieve substantially the same results of the present invention.

Claims (3)

PATIENT INDIVIDUAL POINTS 1. Suction tube for blood collection, where the collecting tube is open at one end and closed at the other end; the open end of the collecting tube comprising a sealing sealing closure inside the collecting tube, characterized in that the collecting tube material has a polyethylene terephthalate ranging from 99.5 to 92% by weight, a polyamide of varying m-xylenylene ranging from 0.5 to 8% by weight contains a transition metal based on polyamide based on polyethylene terephthalate and m-xylylene. 2. The suction tube according to claim 1, wherein the m-xylylene-containing polyamide is poly-m-xylylene adipic acid diamide. 3. Suction tube according to any one of claims 1 to 3, characterized in that the material comprises blue or magenta ink.