SK101098A3 - 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

A method and apparatus for handling biological fluids from thin-walled containers

Technical field

The present invention relates to a method and apparatus for handling and collecting biological samples maintained in thin-walled containers such as those obtained by dividing the tubular element into a plurality of compartments for the purpose of retaining the samples to be analyzed.

The present invention offers important characteristics of novelty and inventive action in relation to the state of the art, allowing the handling of biological fluids in a manner that offers considerable protection against external contamination and avoids the possibility of leakage from the sample.

The invention is particularly useful for handling 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 transfusion, usually kept in pockets of PVC with some anti-coagulant (anti-clotting agent) and are labeled accordingly. The contents of these containers must be analyzed on numerous occasions, at least for each patient eligible for transfusion, 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 the outside). errors in the identification process

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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 (for example, by numbers or dashed codes), so that each segment comprises at least one distinct label. When 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,

- Liquid may be spilled into the tube

- Inhalation, and there is a risk of contamination of the sample from outside as well as from the sample outwards and between samples, and the risk to humans of viral and bacterial infections (through 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 some aliquot parts 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 problems described above by means of a method and apparatus for collecting and handling blood samples retained in thin-walled container parts, allowing said operations to be performed safely and aseptically, without any real possibility of actual contact with the analysts and enabling to ensure that 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 element 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 that used in In the case of a test tube, this intermediate receptacle contains shock absorbing and centering means inside

Receiving a thin-walled tubular container for holding a biological fluid sample, thus forming a lower small container for collecting the biological fluid that will 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 essentially comprise the following sequential steps:

- positioning the tubular container element, preferably assembled with thin walls, containing a biological sample inside, within the intermediate receptacle and engaging it with means for centering and holding, perforating and cutting or tearing the side wall of the tubular element retaining the 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 portion to facilitate air inflow, compressing the tubular member holding the biological, the sample assembly has been emptied toward the intermediate receptacle or emptied by gravity where the upper air inlet is provided, pipetting the sample to undergo the required analysis,

- temporary storage of the device holding the tubular element, bearing legible markings for the purpose of identifying the sample.

sample to the inside

The device for carrying out this procedure should be

- biological biological preferably made of a low cost plastic material provided with means for centering and holding the tubular sample retaining element, with a small fluid collection container after the tubular member is broken and compressed, means for breaking the tubular member and for compressing are provided its content.

In a preferred embodiment of the method, the intermediate receptacle is made 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 a tubular element containing a biological sample. In this embodiment, one portion is preferably attached to the other in one piece or by hinges that can be disposed in a bottom extending longitudinally or laterally.

In all cases, it must be possible to carry out the process which is the subject of this and in a rapid manner and under conditions, aseptically.

either by being molded it is assembled with the outer parts of the housing of the invention which are particularly comfortable

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 appreciate the internal one

-6the 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 the apparatus of 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. numeral 1, which is the usual tubular unit comprising various individual trays of this sample, the unit is placed inside a special device, which essentially contains Part 2 ^Ρ Γ θ purpose of holding the tubular element, part 2, which can be attached to section 2 and which is designed to squeeze and break at different points of the cartridge 1, and a portion 1 in which a small cartridge is arranged at the bottom, preferably the bottom portion is common to portions 2 and 2 and preferably designed to capture a sample of fluid to be analyzed . At least one part of said parts or components 2 and 2 will be constructed of a transparent material in order to be able to read out the sample identification markings relating to the container containing said sample.

After the thin-wall container 1 is positioned and centered, the container is preferably assembled of a thin plastic material, will be held in position by the abutment 2, which may take various forms, and will be subjected to the action of part 2 of the device, place to produce transverse squeezing of tray 1 and at the same time

-7 its failure through contact at several points, one point preferably situated near (adjacent) the lower end, and the other point (s) being located closer to the top to allow air inlet to allow the pipe to be completely emptied; this will contribute to the effect of squeezing part 2 on part 2, thereby compressing a tube whose contents flow into the lower small container 1 in the form of a liquid mass S1, 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 of these operations are performed through a pipetting system, as schematically shown in FIG. 7, with a pipette needle 2. Alternatively, the container (tube) can be emptied through a single lower perforation that is made in such a way as to prevent any air inlet and compression.

The parts 2 and 2 of this device will preferably be hinged in the lower part 6. However, the main characteristic of this device is that the two parts 2 and 2 can be moved relative to each other in order to clamp and squeeze the inner tubular container 1 so that the arrangements of the two parts can be changed; for example, they can be movable in the form of a laterally hinged container and cover portions, or arranged in any other way that achieves the desired objectives, i. that this thin-walled container carrying a certain sample for analysis is well centered so that the fluid of the tubular container is collected, the integral components of this are secured so that the container is broken and compressed, the unit assembled in this way offers fluid-tight conditions similar to those of and allowing this device to be used in later analytical phases.

contained in the aforementioned and also as soon as the equipment adapted

In order to achieve the desired objects, the device of the present invention comprises an inner passage fi which is substantially aligned with the liquid mass 6 in the lower small container 4 to allow for insertion of the pipette needle 2, as well as the means provided with cutting means. of 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 indicated by reference numerals 2, 10 and 11. One of these components will cut into the tubular member near (adjacent to) 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 enter the container. to assist in the process of emptying it. In the case shown in FIG. 1 and 2, the component 2 is provided with protruding points 2, 12 and 11 and the element or part 2 has a corresponding recess 12, 13 and 14 to allow the cutting components to be partially inserted into the tubular component 1 to break its walls.

For the purpose of holding the two components or Parts 2 and 2 of this device, as soon as breakage and pushing actions occur, it will be possible to secure the side flaps (or flaps) 12, or other similar components in one of these parts, these flaps are designed to 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 2 by means of a suitable bolt 12, as shown in FIG. 2 and £.

Thus, the method of the present invention will comprise a first stage of centering and axial holding

- a certain tubular member within the wall of the rupture and presser device, thereafter simultaneously transversely breaking at a point at the lower end of the tubular member and optionally at points located at its top, and finally squeezing the container to expel the fluid held therein; the emptied tubular container becomes located within the device, the device preferably being made of transparent materials in order to allow the used container to function as a carrier of labels identifying the sample in question, thus allowing the sample to be identified both visually and automatically in an automated analytical device.

Claims (6)

PATENT CLAIMS A method for collecting and handling biological fluids from thin-walled tubular containers in which they are held and handled, characterized in that a thin-walled tubular element which can be provided on the outside with identifying markings and is inserted inwards is used to retain the fluid sample. a device having transparent walls centered laterally and axially, the device may also perform controlled breakage of the container at a point adjacent to its lower end for emptying and optionally at points near its upper end to provide air intake wherein the tubular element is simultaneously transversely compressed to be compressed, the tubular element is securely positioned in the container by the breakage and presser so as to ensure that the identification data of the sample contained in the thin-walled container can still be te read (scanned). Apparatus for collecting and handling biological fluids from thin-walled tubular containers in which the handling thereof is retained by the method of claim 1, characterized in that it comprises at least two parts which can be connected to each other, one part movable relative to the other and includes means for radially and axially holding the thin-walled tubular container containing the fluid sample, and provided with means by which the two portions may cooperate to cause the thin-walled container to break at the desired points, the portions being assembled so that they can be compressed after being This container is broken, and the portion that directly receives the thin-walled container is transparent to facilitate reading from outside the identification markings that identify the container holding the sample to be analyzed. Device according to claim 2, characterized in that both its parts are connected to the liquid-impermeable reservoir part, so that it can receive the liquid for analysis which is retained in the thin-walled reservoir. 4th Apparatus according to the claims, characterized in that its two parts for receiving from a plastics material part of this container part device. 2 and 3, showing the connecting parts and the container form a unit made by means of which the two mains are hinged to and from this Device according to claims 2a3, characterized in that the two parts are hinged to each other and one of them is integral with the reservoir part for receiving fluid for analysis. claims 2 to 5, characterized in that one of the two channels providing access for the interposed so that it is The device according to the indicative part maintains an axial pipetting needle that can be drawn into the cartridge part. Device according to claims 2 to 5, characterized in that one of said parts is provided with cutting elements capable of cutting or perforating the sample holding container at the desired points -12k analysis. The apparatus of claim 7, wherein one portion of the apparatus is provided with a recess that cooperates with cutting elements of the other portion to compress and cut the fluid holding container for analysis. Device according to characterized by integral parts of the claims, characterized in that this 2 to 8, that between the two devices holding means are provided which allow them to be fixed in position after being engaged with each other. 11th Apparatus according to the designation of parts and cartridges to form a unit such as that of the tube. of claims 2 to 9, characterized in that the two integral parts can be engaged with each other whose overall form is similar