SK282943B6 - Method and apparatus for the extraction and handling of biological liquids from thin walled receptacles - Google Patents

Abstract

The invention provides apparatus which comprises a minimum of two sections (2, 3) which can be interengaged with one another, one section being capable of being moved relative to the other, and having means for radially and axially holding the thin-walled tubular receptacle (1) containing a biological liquid sample and being provided with means to ensure that on engagement of the two sections with one another the thin-walled receptacle is ruptured at the required points, the said sections comprising components of the device which are joint structures for the purpose of squeezing the thin-walled receptacle after the receptacle has been ruptured, the section directly receiving the thin-walled receptacle being transparent, so as to make it possible to read identifying marks on the said sample-holding receptacle from without.

Description

Technical field

The invention relates to a method for collecting and handling biological fluids in thin-walled tubular cartridges in which fluids are retained, as well as a device for carrying it out. The invention is particularly applicable to the treatment of blood products such as blood, red blood cells, serum, and the like. and facilitates their analysis.

BACKGROUND OF THE INVENTION

Currently, there are blood, red blood cells, serum etc. taken from a person envisaged, for example, for a transfusion, usually kept in pockets of PVC with some anti-coagulant (anti-clotting agent) and are appropriately labeled. The contents of these containers must be analyzed on numerous occasions, at least for each patient who may be transfused, and in these procedures it is very important to prevent accidental contamination (both contamination of the contents of the container and contamination of the contents from outside). error during the identification of the samples.

Normally, each pocket is provided with a long PVC tube which is filled with fluid from the pocket after collection and is immediately sealed at several points and at its end by welding the walls of the tube in a high-frequency manner (or in any other way). Thus, several segments are formed which contain samples of a given fluid and are stored without being cut off or separated from the given pocket. The tube and the casing may be labeled multiple times (e.g., by numbers or dashed codes), so that each segment comprises at least one distinct label. If high-frequency welding is used, the electrodes may leave a notch in the welded joint so that these segments can be separated from each other by pulling, leaving both ends completely closed and avoiding any fluid leakage. This whole process is safe and free of contamination.

When the contents of a pocket have to be tested, the last of the segments is separated and the test is carried out on the basis of the liquid contained therein. For this purpose, a test tube is usually taken and placed on a rack and the segment is cut with scissors and emptied using a test tube, then the empty portion is discarded and the test is performed in a test tube previously marked with the same number as the one .

Under the following conditions:

- because it has become separate from the segment, a sample has ceased to be separately identified,

- when cutting a segment, a block or end piece is separated and must be discarded,

- the scissors become contaminated and must be cleaned for the next sample,

- Spillage of liquid into the test tube may splash out and there is a risk of contamination of the sample from outside and between and out of the sample, and the risk to humans of viral and bacterial infections (via AIDS, jaundice, etc.).

The same or similar problems are found in other processes used to recover fluid from within certain segments. Thus, we conclude that since the generation of a number of aliquots from the sample through the segments is a clean and safe system, the continued use of these segments is very unsatisfactory due to the fact that this does not allow a high standard of hygiene and this is potentially dangerous.

The present invention seeks to overcome these described problems by means of a method and apparatus for collecting and handling blood samples retained in thin-walled reservoirs, allowing said operations to be performed safely and aseptically, without any real possibility of actual contact with the analysts and enabling so that the samples are easily identified throughout the test cycle.

SUMMARY OF THE INVENTION

To achieve these objectives, the present invention provides an apparatus comprising an intermediate receptacle for receiving a tubular member holding a biological fluid sample, the receptacle being constructed to be generally similar to a test tube, in order to make it possible to treat the sample in a manner similar to used in the case of a test tube, the intermediate receptacle comprises shock absorbing and centering means within it for receiving a tubular container with thin walls for holding a biological fluid sample, thus forming a lower, small container for collecting the biological fluid to be released from the tubular member retaining it , by any suitable means. The size of the intermediate receptacle must be such that, in relation to the tubular element containing the biological sample, it allows pipetting to be carried out, possibly by an automatic device of the intermediate receptacle. The method for handling biological fluid samples will also in principle include the following sequential steps:

- positioning the tubular container element, preferably assembled with thin walls, containing a biological sample inside the intermediate receptacle and engaging it by means of centering and holding,

- perforating and cutting or tearing the side wall of the tubular member retaining said biological sample at least at one point, preferably near (adjacent) the bottom of said circular member and, optionally, performing one or more additional perforations in its upper part to facilitate air inflow,

- compressing the tubular element holding the biological sample so that the whole of the sample is emptied towards the interior of the intermediate receptacle or emptied by gravity in the case where the upper air inlet is provided,

- pipetting the sample to undergo the required analysis,

- temporary storage of a device holding a tubular element which is provided with legible markings in order to identify the sample.

The apparatus for carrying out the process should preferably be made of a low cost plastic material which is provided with means for centering and holding the tubular element holding the biological sample, with a small reservoir for collecting the biological fluid, after the tubular element is broken and compressed, provided means for breaking the tubular member and compressing its contents.

In a preferred embodiment of the method, the intermediate receptacle is made up of two parts or sections, one of which comprises centering and retention means for the tubular element containing the biological sample as well as means such as protrusions, blades or other suitable components for making cuts in the tubular member. a tubular element containing a biological sample. In this embodiment, one part is preferably attached to the other either by being molded in one piece or by being assembled with external hinges which can be positioned in the lower part of the housing extending longitudinally or laterally.

In all cases, it must be possible to carry out the process of the invention in a convenient and rapid manner and under conditions which are particularly aseptic.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to facilitate understanding of the present invention, the accompanying drawings are enclosed by way of an explanatory but non-limiting example illustrating an embodiment of the present invention in which:

Fig. 1 and 2 show a schematic cross-sectional view of one embodiment of the device according to the invention.

Fig. 3 shows a top view of the device according to the invention, giving the possibility to assess the internal visibility of the tubular element due to the fact that it is transparent.

Fig. 4 shows a schematic cross-section of the device itself.

Fig. 5 and 6 are perspective views of the device of the present invention, showing the components in the open and closed positions, respectively.

Fig. 7 is a cross-sectional view of a device according to the present invention showing the location of a pipetting needle.

DETAILED DESCRIPTION OF THE INVENTION

According to the present invention, in order to handle and withdraw fluids from thin-walled containers, containers will be cut in one of these containers designated in FIG. The numeral 1, which is a conventional tubular unit containing various individual containers of this sample, is located inside a special device which essentially comprises a part 2 for holding the tubular element, a part 3 which can be attached to the part 2 and which is designed to squeeze and break at various points of the cartridge 1, and a portion 4 in which a small cartridge is disposed at the lower portion, the lower portion preferably being common to portions 2 and 3 and preferably designed to capture a sample of fluid to be analyzed. At least one part of said parts or components 2 and 3 will be constructed of a transparent material in order to be able to read from outside the sample identification markings relating to the container containing the sample.

After the thin-wall container 1 is positioned and centered, the container is preferably constructed of a thin plastic material, will be held in position by abutment 5, which may take various forms, and will be subjected to action of part 3 of the device, in the first place producing transverse compression of the cartridge 1 while breaking it through contact at several points, one point preferably located near (adjacent) the bottom end and the other point (s) located closer to the top to allow air inlet to allow the tube to be completely emptied; this will contribute to the effect of squeezing part 3 on part 2, thereby compressing the tube, the contents of which will flow into the lower small container 4 in the form of a liquid mass 6, which will then be available to receive reagents; this small container has the ability to be partially displaced if necessary, and can be further handled, all these operations are carried out by means of a pipetting system, as schematically shown in FIG. 7, with a pipette needle 7. Alternatively, the container (tube) can be emptied by means of a single lower perforation which is made in such a way as to prevent any air inlet and compression thereof.

The parts 2 and 3 of this device will preferably be hinged in the lower part 4. However, the main characteristic of the device is that the two parts 2 and 3 can be moved relative to each other for clamping and squeezing the inner tubular container 1, whereby the configurations of both parts may be changeable; for example, they may be movable in the form of a laterally hinged cartridge and cover portions, or arranged in any other way that achieves the desired objectives, i. j. that the thin-walled container carrying a certain sample for analysis is well centered so that the liquid contained in said tubular container is collected and, as soon as the integral components of the device are adapted to ensure breakage and compression of the container, the unit assembled therein In this way, it offers fluid-tight conditions that are similar to those in a test tube, allowing this device to be used in later analytical phases.

In order to achieve the desired objects, the device of the present invention comprises an inner passage 8 which is substantially aligned with the liquid mass 6 in the lower small container 4 to allow the pipette needle 7 to be slid, as well as the device provided with means for cutting said tubular element, said means being assembled in the form of sharp points or projecting points of another type, knife components, etc., which are schematically shown in the drawings and designated with reference numerals 9, 10 and 11. One of these components will cut into the tubular element near (adjacent) the bottom end, which is designed as an outlet for the contents of the container, while the other means, when provided, will be situated on the upper part of the container to allow air to be drawn into the container to assist in the emptying process. In the case shown in FIG. 1 and 2, the component 2 is provided with protruding points 9, 10 and 11, and the element or part 3 has a corresponding recess 12, 13 and 14, to allow the cutting components to be partially inserted into the tubular component 1 for breaking its walls.

In order to hold the two components or parts 2 and 3 of this device, as soon as the breakage and pushing actions do not occur, it will be possible to secure the side flaps (or flaps) 15, or other similar components in one of these parts, these flaps are designed to they could be inserted into each other, as shown by the figure 16 in FIG. 5, and the same effect can similarly be achieved by other fastening components ensuring that the two components are well secured to each other.

Therefore, in order to achieve the desired effect, it will also be possible to suspend the two parts 2 and 3 by means of a suitable pivot 17, as shown in FIG. 5 a

6th

Thus, the method of the present invention will comprise a first stage of centering and axially holding a particular tubular member within the wall of the breakage and presser device, subsequently simultaneously transversely breaking it at a point at the lower end of the tubular member and optionally at points located at its top and finally, depressing the container to displace the fluid held therein, the emptied tubular container becomes located within the device, the device preferably being made of transparent materials to allow the used container to function as a carrier of labels identifying the sample in question, thereby enabling identification this sample both visually and automatically in an automated analytical device.

Claims (10)

PATENT CLAIMS 1. A method for collecting and handling biological fluids in thin-walled tubular containers in which they are contained, characterized in that a thin-walled tubular container equipped with identifying markings on the outside is used to retain the fluid sample, which is inserted inside the transparent-wall device, that it is centered laterally and axially, there is also a controlled breach of the container at a point adjacent to its lower end for emptying and optionally at points near its upper end to provide air inlet and the tubular container is simultaneously compressed laterally, this the tubular container is securely positioned by the rupture and pusher device, ensuring that the sample identification data contained in the thin-walled container is read. Device for carrying out the method according to claim 1, characterized in that it comprises at least two parts (2, 3) connected to each other, one part being movable against the other, further comprising means for radially and axially holding the thin-walled tubular container (2). 1) with a fluid sample and is provided with means for cooperating a portion (2, 3) for breaking the thin-walled tubular container (1) at designated points and compressing them after the container (1) has been broken, wherein at least one portion (2, 3) directly receiving the thin-walled tubular container (1) is transparent to facilitate reading from outside the identification devices identifying the container holding the sample to be analyzed. Device according to claim 2, characterized in that both parts (2, 3) are connected to the lower reservoir (4) with liquid impermeable properties for receiving the fluid retained in the thin-walled reservoir (1) for analysis. Device according to claims 2 and 3, characterized in that the two parts (2, 3) and the lower container (4) form a unit of plastic material for hanging them together. Device according to claims 2 and 3, characterized in that the two parts (2,3) are hinged to one another, one of which is integral with the fluid receiving container (4) for analysis. Device according to claims 2 to 5, characterized in that one of the parts (2, 3) comprises an internal passage (8) for accessing a pipette needle (7) extending into the lower container (4). Device according to claims 2 to 5, characterized in that one of the parts (2, 3) is provided with protruding parts (9, 10, 11) for cutting or perforating the cartridge (1) at the desired points. Apparatus according to claim 7, characterized in that one of the portions (2, 3) is provided with a recess (12, 13, 14) for inserting the projecting portions (9, 10, 11) of the other portion to compress and cut the cartridge (1). ). Apparatus according to claims 2 to 8, characterized in that it comprises retaining means for securing the position of the integral parts (2, 3) after engagement, preferably comprising side flaps (15), a pin (17) and the like. Device according to claims 2 to 9, characterized in that the two integral parts (2,3) and the lower container (4) form a tube-shaped unit.