PT99171B - METHOD FOR PREPARING A BLOOD COLLECTION CONTAINER CONTAINING POLYETHYLENE TEREFTALATE AND A POLYAMIDE - Google Patents

Abstract

The invention relates to a container with an internal vacuum for the collection of blood which comprises a tube with one open end and one closed end, this tube being prepared from a composition comprising from 99.5 to 92% by weight of polyethylene terephthalate, 0.5 to 8% by weight of a polyamide which has an m-xylene group and between 1 and 100 ppm of a transition metal with respect to the polyethylene terephthalate mentioned and the polyamide mentioned which has an m-xylene group, and a plug to plug the open end of the said tube in such a way as to conserve vacuum within the tube. In accordance with the invention a vessel with an internal vacuum is provided for the collection of blood which has excellent gas impermeability and can maintain vacuum within it for a long period of time.

Description

BACKGROUND OF THE INVENTION

The present invention relates to a recipient with an internal vacuum for blood collection ¹ . More particularly, a tubular container with an inner vacuum for collecting blood in which the variation of the vacuum inside is small over time until use. In particular, the inner pressure in the vacuum of the container varies little during storage.

A recipient with an internal vacuum for blood collection is used for tests and measurements such as biochemical tests, serological tests, hematological tests, blood sugar measurement, blood clotting tests, erythrocyte sedimentation speed test and bacteriological tests. Normally, a blood collection container includes a tube with a closed end and an open end and is equipped with a rubber stopper at the open end. Before use, a vacuum is made inside the aforementioned container that includes a tube with a flat end and a rubber stopper. Then, the pressure is maintained inside the container with vacuum inside in a condition in a condition of adequate vacuum in order to allow to collect a necessary amount of blood (2 to 20 ml).

Until now, a tube material with a métre extermé closed from the récipiénté with an interior vacuum referred to above was glass. However, glass is fragile in handling, it is a high speed centrifugation procedure and it is analogous. Thus, the glass has recently been replaced by synthetic resins.

As synthetic resins used in the inner vacuum container for blood collection, they are selected from polyesters, polyethylene, polypropylene and the like. Déntre 'éstas is used as a general polyester since polyester is better than polyethylene or polypropylene or the like in gas impermeability.

However, polyester is inferior to glass in its impermeability to gas, since oxygen is nitrogen gas, passing through the authentic polyester tube. Thus, a vacuum condition cannot be maintained within the container, which includes a tube made of a polyester in the case of long-term storage. The interior vacuum trap for blood collection including the authentic tube of a commonly used synthetic resin has an impermeability ¹ to the lower gas in comparison to that of a interior vacuum with a blood vacuum that includes ¹ authentic glass tube. For reasons previously referred to, we have carried out studies of packaging material for a container with an inner vacuum for collecting blood including the tube made of synthetic resin, for example, the container with an inner vacuum for collecting blood is

packed in a vacuum for storage, the specific gas is' placed inside a container of the récipiénté with an internal vacuum for collecting blood and the like.

object of this invention is to provide a container ¹ 'inside to a vacuum blood collection comprising a tube made of a synthetic resin and which has a waterproof' the excellent gas. According to the present invention. tion can maintain the vacuum inside the container to collect blood at a vacuum during a long ^first period of time before use.

These are other objectives of the present invention become obvious from the description below.

SUMMARY OF THE INVENTION

According to the present invention, a vacuum with an interior vacuum is provided for collecting blood which includes:

A tube with a closed end is an open end; if the tube is prepared from a composition consisting of 99.5 to 92% by weight of polyethylene, 0.5 to 8% by weight of a polyamide having a m-xylylene group is 1 to 100 ppm, with based on the shortest polyethylene therphthalate and the shortest polyamide having a m-xylylene group of a transition method; is a system to close the extreme end of the tight tube to keep the inside of the tube in a vacuum.

With a vacuum with an inner vacuum as previously 're'fertile, the objective of the present invention can be achieved.

DETAILED DESCRIPTION

Next, an interior vacuum is explained to collect blood from the present invention, with

Q detail.

In the present invention , the term system ¹ to close a system means to fit the open end of the container tube ¹ inside to a vacuum collection 'blood. That is, the open end of the tube is covered with a closing system to keep the inside of the tube in a vacuum. The system for closing may be punctured with a needle to draw blood. At the time of using the vacuum with an internal vacuum to collect blood from the present invention, one end of the needle to draw blood 'is inserted into a vein and the other end of the needle to draw blood'is' inserted into the recipient with an inner vacuum through the system for close. The blood is drawn into the récipiénté with the inner vacuum through needles to remove blood due to the vacuum in the récipiénté. Examples of closing systems are, for example, a rubber cover having an elasticity that is susceptible to being removed ^{: it} fits; a closing system consisting of a means for gas impermeability is a means for sealing and analogues.

In the present invention, the term a tube with a closed end means a tube that can be used in a vacuum with an interior vacuum for collecting blood '. The tube ends with a closed end are, for example, a tube having an outer diameter between '10 and' 16 mm (0), a length of 60 'and 170 mm is a thickness of 1' and 2 mm and the like.

The polyethylene téraftalate used in the present invention is a widely used polyester which can be obtained by reaction of ethylene glycol, theréphthalic acid or an etheric séé (éspécialménté, dimétilé theréphthalate). The previous polyethylene therphthalate also includes a polyethylene therphthalate containing units of ethylene thermorphthalate in a proportion of not less than 80%. Examples of copolymerizable components are, for example, isophthalic acid,

maftalenedicarboxylic, a derivative of p-oxybenzoic acid; butanediol are analogues.

For molding, it is pre-fertile that the molecular weight of the polyester polymer refarmed above is such that it has an intrinsic viscosity of 0.6 to 0.9 (n) to provide a satisfactory tube with the closed end. That intrinsic viscosity and a maximum value at 25 ² C in a solution obtained by dissolving '0.25 g of the polymer is 100 ml of' a mixture of 3 parts is for phenol and 2 parts is for 1, 1,

2,2-tétra-chloro-ethane.

The polyamide having a m-xylylene group used in the present invention includes an amine component at least diamine selected from the group consisting of (1) m-xylylenediamine, (2) a mixture of m-xylylene diamine and p-xylylene diamine, is (3) a mixture of 'm-xylylenediamine is hexamethylenediamine; and 'a component' acid at least a carboxylic acid selected from the group consisting of adipic acid, subric acid, azalic acid and sebacic acid. As the polyamide having m-xylylene group of the present invention is preferable ^one poly-m-xylylene adipamide. It should be noted that the polyamide having the m-xylene group of the present 'plays a very important role in improving the gas tightness of the pipe with the closed end.

As a transition metal used in the invention are ^first pre feel cobalt examples, nickel, rhodium and the like. In the present invention the 'transition metal' is used in the form of a salt. Examples of the transition metal salts used in this invention are, for example, cobalt acetate, cobalt naphthenate, cobalt stearate, nickel acetylacetonate, nickel chloride, ¹ rhodium chloride and the like.

tube of the present 'invention which is' prepared by mixing a polyamide having an m-xylylene group and 'a transition metal salt absorbs' gaseous oxygen.

matter! of the tube with the closed end of the present invention is a mixture of polyethylene therphthalate, a polyamide having a m-xylile group and a salt of a transition metal. You can load a mold 'with the three components at once in a molding step. Altérnativaménte ', the three components can be pre-mixed ¹ before loading the mold with the mixture of the three components.

Since the tube with the closed end of the present invention is molded by mixing a polyamide having a m-xylylene group, the product may turn yellow. However, the yellow color of the product can become colorless by means of a good balance in the constitution of the three previous components. The yellow color can also become imperceptible by adding up to 4% of weight, based on the polyethylene therphthalate a granule containing a blue pigment or purple pigment to the mixture of the three components. As the main granule, polyethylene therphthalate is used. The main granule contains, for example, 1% of the pigment. It is preferable that the master pellet containing a blue pigment or purple pigment is added to the mixture in equal amounts of ¹ to a polyamide having m-xylylene group. Examples of such pigments used in the present invention are, for example, Blue N ⁹ 1 (CI42090), Blue N ⁹ 2 (CI73015), Blue N ⁹ 201 (CI73000) Blue N ⁹ 202 (CI42052)., Blue N ⁹ 203 ( CI42052), Blue N ⁹ 204 (CI69825), Blue N ⁹ 403, Purple N ⁹ 201 (CI60725), are analogues.

In the present invention, the tube is prepared by mixing a polyamide having a m-xylylene group, a polyester which is widely used is a salt of a transition metal in order to provide the tube with the closed end that has an impermeability to the exxcellable gas. it absorbs gaseous oxygen. It should be noted that a salt of a transition method is a catalyst to accelerate such behavior.

In the recipient with an inner vacuum for blood flow including a genuine synthetic resin tube of the present invention that has excellent gas impermeability as previously described, the gaseous oxygen is absorbed

and- then the interior of the container with an internal vacuum for blood flow remains in a vacuum for a long period of time before use.

i In the present invention ¹ is necessary that the pro moiety in the aforesaid mixture is comprised tween 99.5 to 92% by weight, preferably from 99 to 96% by weight as polyethylene terephthalate is between 0.5 to 8 % ém pso, dé í

preferably between 1 and 4% is as heavy as the polyamide having the m-xylylene group. When the proportion of a polyamide having the group m-xyliléno is' greater than 8% is heavy, the déteriora se transparency is the cost of the material of the tube is superior. On the other hand, when the proportion of a polyamide having the m-xylylene group is' less than 0.5%, the capacity for absorption of gaseous oxygen is reduced.

In the present invention it is' necessary that the material of the tube contains 1 to 100 ppm, preferably 2 to 50 ppm of a salt of a transition method is greater than 100 ppm the tube obtained is ¹ colored, the transparency is off. is the cost of the material is ¹ more high. On the other hand, when the salt content of a transition method is less than 1 ppm, the function of the catalyst which accelerates the absorption of gaseous oxygen deteriorates.

The polymer used to prepare the tube with the closed end of the present invention can contain additives that do not have a harmful influence. Examples of additives are, for example, an antioxidant, an agent for blocking ultraviolet rays, an auxiliary agent for extrusion, an additive for polymeric apérféçoaménto and the like.

The present invention is more specific, it is explained by means of the following examples, comparative examples are the following examples in which all the parts are identical except if indicated otherwise. It is to be noted that the present invention is not limited by examples, comparative examples and examples of experiment and several variations

çõés is modifications in the invention without departing the spirit from its scope.

EXAMPLES 1 to 10 and COMPARATIVE EXAMPLES 1 to 3

Using the materials presented in table 1, each tube was pre-prepared with a closed end. It is an open end for collecting 5 ml of blood having a thickness of 1.3 mm, a length of 75 mm is an inner diameter of 10.8 mm the tube thus obtained was closed impermeably with a rubber cap made of butyl gum.

In each group, ten récipiéntes were prepared

In Table 1, polyethylene therphthalate was used, poly-m-xylylene-adipamide is a dye classified in anthraquinones as a polyester, a polyamide having a m-xylylene group is a blue pigment, respectically.

TABLE 1

Number

Proportion in weight of Polyester / Polyamide having a group m-xylileho / Main granule containing blue pigment

Concentration of cobalt (ppm)

Ex. 1 100/1/0 23 Ex. 2 100/1/0 5 Ex. 3 100/1/2 5 Ex. 4 100/2/0 10 Ex. 5 100/2/0 5 Ex. 6 100/2/0 1 Ex. 7 100/4/0 100 Ex. 8 100/4/0 20 Ex. 9 100/4/0 10 Ex. 10 100/4/0 2

With. Ex. 1 100/0/0 0 With. Ex. 2 100/4/0 0 With. Ex. 3 100/0/2 0

TEST EXAMPLE 1

In each group, ten recipients were used to measure their inner pressure.

An internal pressure of each of the containers obtained according to examples 1 to 10 is comparative examples 1 to 3 has been reduced to 460 mmHg (300 mmHg vac.) To provide a recipient with an internal vacuum for blood collection.

Relatively to each of the containers with an inner vacuum, the inner pressure was measured at 50 ² C for 3 weeks, that is to say, it is exactly after being closed, 3 weeks later, 6 weeks later, 9 weeks later, 12 weeks after that is 15 weeks after.

When the pressure in the interior is exactly since it has closed since it was 100%, the retention speed (%) was calculated relative to the degree of vacuum from the average value. The results are shown in Table 2.

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TEST EXAMPLE 2

In a manner similar to the one described in the trial run 1 with the exception that the inner pressure of each specimen was reduced to 310 mmHg (450 mmHg vac.), The interior pressure of the specimen was measured with an internal vacuum for blood collection. '.

When the inner pressure is exactly after being closed, it is 100%, the speed of retention (%) relative to the degree of vacuum was calculated from the measured value. The results are shown in Table 3.

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TEST EXAMPLE 3

In a 'semélhanté way to that described in test example 1 with the exception that the inner pressure of each container was reduced to 30 mmHg (730 mmHg vac.), The inner pressure of the récipiénté was measured with an inner vacuum for blood collection' .

When the pressure in the interior is dexacted after it has been closed, it was 100%, the retention speed (%) was calculated relative to the degree of vacuum from the average value. The results are shown in Table 4.

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Days of storage at 50 ⁹ C

In examples 1 to 3, temples of 50 ⁹ C were used, which are slightly different compared to the ambient temperature as well as the period, that is, 15 weeks may be as short as an observation period.

As is evident in the results presented in Tables 2 to 4 for higher concentrations of cobalt, oxygen is more quickly absorbed. Also, for higher content of polyamide having the m-xylylene group, oxygen absorption is faster.

Note the difference between the results in Tables 2 to 4. The reason is that the amount of gaseous oxygen to be absorbed differs due to the difference in the degree of the vacuum. That is, the greater the vacuum in the récipiénté for collecting blood less is the 'quantity' of gaseous oxygen within the récipiénté.

There is also no influence on the impermeability of the gas even when using a blue pigment in the preparation of the tube of the present invention.

In addition to the ingrédiéntés used in the examples, comparative examples are in the examples, we can use other inputs in the examples, comparative examples are examples as shown in the descriptive memory to obtain the same results.

Claims (2)

Récipiénté with inner vacuum for collection of blood characterized by compréendér: a tube with an open end is with a closed end, if it is a pre-prepared tube from a composition consisting of 99.5 to 92% of polyethylene thermophthalate, 0.5 to 8% of a polyamide that has a m-xylene group éntré 1 to 100 ppm of a transition metal, taking as base the referred polyethylene therphthalate is the referred polyamide which has a m-xylene group; it is a cover to cover the open end of the tube in order to keep the vacuum inside this tube. - 2 - Interior vacuum vacuum according to claim 1, characterized by the fact that the polyamide has a m-xylene group and a poly-m-xiiene-adipamide group. _ 3rd _ Interior vacuum vacuum according to any of the preceding claims, characterized by the fact that the composition contains a blue pigment or a purple pigment.