JPH06165772A - Assembly of blood-collecting pipe - Google Patents

Abstract

PURPOSE: To improve the barrier characteristic of a polymer-made product, particularly a plastics-made vacuum type blood collecting tube. CONSTITUTION: A coating 25 consisting of a diamond composition is vaporously deposited, or the coating of the diamond of a plastic vessel 10a coated by a barrier label coated by the diamond provides an effective barrier against the permeation of a gas into the vessel, and useful for prolonging the life of the vessel, particularly the plastics-made vacuum type blood collective tube.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to barrier coatings and barrier labels for providing effective barriers to the permeation of gases and moisture for containers, particularly vacuum blood collection tubes made of plastic.

[0002]

BACKGROUND OF THE INVENTION With the increasing use of plastic medical products, there is a particular need to improve the barrier properties of polymeric products.

[0003] Such medical products that have significant advantages by improving barrier properties include, but are not limited to, collection tubes, particularly blood collection tubes used for blood collection.

Blood collection tubes must meet certain performance criteria required for use in medical applications. As such a performance standard, there is a case where about 90% or more of the original extraction amount is maintained for one year or more, irradiation sterilization is possible, and there is no influence in the test and analysis.

An important performance criterion for blood collection tubes is maintenance of withdrawal volume. Maintaining the draw volume depends on the presence of a partial vacuum in the tube or the reduced pressure. The extraction amount changes in direct proportion to the vacuum (reduced pressure). The extraction amount is maintained because a good vacuum state is maintained.

For example, it is important to maintain the vacuum for a period of time to provide a suitable storage period before the tube is used. That is, it is important that the vacuum level be maintained for a period of time before the medical technician or nurse uses the tube to draw a blood sample.

Radiation sterilization means that the sterilization process is substantially unchanged in optical or mechanical properties and function after exposure of the tube to a certain level of radiation.

The non-influence of the design performance of the tube means that the tube material, such as glass or plastic, does not affect the tests and analyzes normally performed on blood in the tube. Such tests include, but are not limited to, hematology, blood chemistry, blood typing, toxicology analysis, therapeutic drug monitoring, and the like. Furthermore, the tube must be able to be subjected to automated machinery such as centrifugation.

[0009]

SUMMARY OF THE INVENTION It is therefore an object of the present invention to improve the barrier properties of polymer-made products, especially plastic vacuum evacuated blood collection tubes. Such improvements do not obscure the contents of the product,
It meets certain performance criteria and can be effectively used in medical applications.

[0010]

SUMMARY OF THE INVENTION The present invention is a plastic composite container covered with a barrier composition or barrier label disposed over the outer surface of the container. That is, the barrier composition is coated to cover a preformed plastic container, or the barrier label coated with the barrier composition is disposed to cover the outer peripheral surface of the composite container. Such a barrier composition or barrier label improves the barrier properties of a plastic container, but does not affect the contents of the plastic container and prolongs the life of the plastic container, especially the plastic vacuum blood collection container.

A desirable barrier composition or barrier label that can be placed over a plastic container preferably comprises a diamond composition. The diamond composition may be applied to the inside or outside of the container or label.

The barrier label may be placed or formed around the container and then by, but not limited to, heating the adhesive layer to a temperature sufficient to cause the barrier label and container to heat shrink. Alternatively, it may be desirable to adhere to the container by expanding it into the barrier label by blow molding.

The diamond composition provides a transparent, translucent or colorless appearance, with prints desirably provided thereon.

Plastic tubing or barrier labels coated with a diamond composition consist of a polymer composition or mixture and have much better vacuum and draw hold than conventional tubing without a barrier coating or barrier label. it can. In addition, the diamond coating is substantially non-polar, which significantly improves the moisture barrier properties of coated or labeled tubes. The diamond composition has a high degree of transparency and its durability is sufficient to withstand impact, abrasion and scratching.

Films suitable for coating for use as barrier labels according to the present invention include:
Not only polypropylene film but also low density and high density polyethylene film and polyvinyl chloride film.

Printing may be provided on the barrier composition or label used on the container. For example, product identification, bar code, brand name, company logo, lot number, expiration date and other data and information can all be included on the surface of the label. In addition, a material finish or corona discharge surface may be formed on the outer surface of the barrier composition to write additional information on the label. Further, another pressure sensitive adhesive label may be placed on the outer surface of the barrier label, for example to incorporate various hospital labels.

[0017]

DESCRIPTION OF THE PREFERRED EMBODIMENT In the drawings, like parts are provided with like reference numerals. 1 and 2 show a typical blood collection tube 10 that includes an open end 16, a closed end 18, a stopper 14 that includes a lower annular portion or skirt 15, and a skirt portion 15. Extends into the inner wall under pressure of the lumen 12 of the tube to maintain the stopper 14 in place. FIG. 2 shows three mechanisms for changing the vacuum state in a blood collection tube, that is, (A) gas permeation through a stopper material, (B) gas permeation through a tube material, and (C) a boundary between a tube and a blocking member. Shows the leakage at. Therefore, when there is substantially no gas permeation and leakage, a good vacuum can be maintained and a good extraction amount can be maintained.

FIG. 3 illustrates a preferred embodiment of the present invention, showing a plastic tube coated with a diamond composition or with a diamond coated barrier label. This preferred embodiment includes a number of components approximately equal to those of FIGS. Therefore, similar components that perform similar functions are:
Components are numbered the same as in FIGS. 1 and 2 except that the subscript “a” is used to identify components in FIG.

In FIG. 3, the preferred embodiment of the present invention, a collection tube assembly 20, includes a plastic tube 10a having an open end 16a and a closed end 18a. A coating 25 comprising a diamond composition or a diamond-coated barrier label is provided at the open end 1.
6a and the closed end 18a extend substantially the entire length of the outer surface of the tube.

FIG. 4 illustrates another embodiment of the present invention in which the collection tube assembly 40 includes a tube 4
A stopper 48 for closing the second open end 41 is included in position. As can be seen, the stopper 48 is
It includes an annular upper portion 50 extending beyond the top edges of the two. Stopper 48 includes a lower annular portion or skirt 49 that extends under pressure within the inner wall of tube 42 to hold stopper 48 in place and define recess 52, which extends through skirt 49. Defining a septum portion 53 for receiving the cannula. Thus, when the user receives a container containing the sample therein, as shown in FIG. 4, the user may receive some or all of the contents of tube 42 for various tests on the sample. The cannula is inserted into the diaphragm 53.

A coating of diamond composition or diamond coated barrier label 45 covers substantially the entire length of the tube. This coating or barrier label 45 covers almost all but the open end 41 of the tube. FIG. 4 differs from FIG. 3 in that after applying a diamond coated or diamond coated barrier label 45 to the tube, the tube is evacuated and a stopper 48 is attached at the same time. Alternatively, the diamond coating or the diamond coated barrier label may be applied after applying a vacuum.

Another embodiment of the invention also includes a coating or label that incorporates both the top of the stopper and the entire tube of the container. Such an embodiment can be used, for example, to seal a container in place with a stopper. When the sample is placed in the tube, it can only be opened by removing the stopper.
Further, a cut portion may be included at the boundary between the tube and the stopper. The notches may be aligned so that it is possible to see if the sealed container has already been opened.

It will be appreciated by those skilled in the art that such a tube may contain additives or reagents in the form of a coating applied on the inner wall of the tube.

The coating of diamond composition forms a transparent or translucent barrier. Thus, the contents of a plastic tube covered with a coating of diamond composition can be seen at the same time that the information displayed on the diamond film is confirmed after being applied to the plastic tube.

US Pat. Nos. 4,698,256 and 4,809,87, which are incorporated herein by reference.
No. 6, and 5,055,318, a coating of a diamond composition is applied by radio frequency discharge, direct or dual ion beam deposition, sputtering or plasma enhanced chemical vapor deposition. It may be formed on the substrate.

The coating of the present invention is preferably a diamond composition containing carbon having a majority of sp ³ tetrahedral bonds and a minor proportion of sp ² bonds. In general, the diamond composition of the present invention consists of carbon atoms bonded in a close chemical structure similar to that of diamond, but having no long range crystal order.

The diamond coating is a dual ion beam ballistic alloy method.
Depending on the alloy process, it is desirable to attach it to a plastic container or barrier film.

A plastic blood collection tube coated with a diamond composition or coated with a barrier label is
Routine chemical analysis, biochemical inertness, hematology, blood chemistry,
It can be effectively used in applications such as blood typing, toxicology analysis or therapeutic drug monitoring and other medical tests involving body fluids.

When the diamond composition is also coated on the inside surface of a plastic blood collection tube, the diamond coating is a blood adhesion inhibitor and / or has the properties of a blood coagulation activator.

It will be appreciated that according to the invention it makes no difference whether the plastic composite container is evacuated or not. The provision of the barrier composition or barrier label on the outer surface of the container has the effect that the container holding the sample can be maintained in a perfect condition, so that the user can dispose of it properly without contamination. Occurs. The transparency, abrasion resistance and scratch resistance of the barrier composition or barrier label is significant.

The diamond coatings or mixtures thereof used according to the present invention may contain conventional additives and ingredients which do not adversely affect the properties of the products made from them.

The barrier label is preferably a film coated with a high barrier performance material such as a diamond composition. Preferred, but not limiting, film materials include polyamides, polyolefins and polyesters. Polyamides include, but are not limited to, biaxially oriented nylon, amorphous aromatic polyamides, polyvinyl chloride, and mixtures thereof. Also, but not limited to, polyolefins include biaxially oriented polypropylene, low density polyethylene, polychlorotrifluoroethylene, and mixtures thereof. Additionally, without limitation, polyesters include polyethylene terephthalate, polyethylene naphthalate, polyethylene isophthalate and mixtures thereof.

[Brief description of drawings]

FIG. 1 is a perspective view of a typical blood collection tube with a stopper.

2 is a longitudinal cross-sectional view of the blood collection tube of FIG. 1 taken along line 2-2.

FIG. 3 is a longitudinal sectional view of a tubular container of the present invention without a stopper.

FIG. 4 is a longitudinal sectional view of the tubular container of the present invention having a stopper.

[Explanation of symbols]

10a plastic tube, 12a, 42 tube,
48 stoppers, 49 skirts, 16a, 41
Open end, 18a, 44 Closed end, 20,4
0 blood collection tube assembly, 25, 45 barrier label, 5
3 septa,

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Claims (10)

[Claims] 1. A sample comprising a plastic tube having an open end, a closed end, an inner surface and an outer surface, and a coating of a diamond composition extending over most of the outer surface of the tube. Assembly. 2. A closure member is included at the open end of the tube to form a closure boundary with the container.
Assembly as described in. 3. The assembly of claim 2, wherein the plastic container is a tube and the closure member is a resilient stopper. 4. A vacuum is applied to the tube.
Assembly as described in. 5. The coating comprises high frequency discharge, direct ion beam deposition, dual ion beam deposition,
The assembly of claim 4, wherein the assembly is deposited by sputtering or plasma enhanced chemical vapor deposition. 6. A plastic tube having an open end, a closed end, an inner surface and an outer surface, and a coating of a diamond composition extending over most of the inner surface of the tube. Sample assembly. 7. A plastic container having an open end, a closed end, an inner surface and an outer surface, and a polymer film coated with a diamond-based composition, wherein the outer surface of the container is large. A sample container assembly comprising a barrier label comprising a polymer film extending over the portion. 8. The assembly of claim 7, wherein the barrier label comprises a polymeric film material selected from the group consisting of polyamides, polyolefins and polyesters. 9. A barrier label comprising a first layer selected from the group consisting of polyamides, polyolefins and polyesters, and a second layer composed of a diamond-based composition. 10. A method of manufacturing a label having high barrier properties for use on the outer surface of a vacuum tube, comprising: a) forming a film from a base resin made of a polymer; and b) then high frequency discharge. , Dual ion beam deposition,
Depositing the diamond-based composition on the film by direct ion beam deposition, sputtering or plasma enhanced chemical vapor deposition.