FR2943532A1 - POCKET SYSTEMS COMPRISING A SAMPLING CONTAINER HAVING AN OPENING DEVICE - Google Patents

Abstract

A bag system (1) for receiving and sampling a biological fluid or a component thereof comprising: - at least one bag (2) for receiving the biological fluid or one of its components, and - at least a sampling vessel (3) in fluid communication with said pocket so as to be able to receive a sample of the fluid contained in said pocket, said sampling vessel (3) being provided with an access port (4) at the sample, said sampling container (3) comprising an opening device (9) mounted in said container opening (4), said opening device (9) having an area of weakness (10) arranged to be able to be broken so as to allow access to the sample through the orifice (4) of said container.

Description

A pouch system for receiving and sampling a biological fluid or one of its components and a sampling method using such a bag system.

The invention applies to the field of transfusion, including the collection and treatment of blood or one of its components. When donating blood, one or more samples of whole blood or one of its components are taken to determine the presence or absence of pathogens such as viruses and bacteria. On the other hand, the blood samples taken also make it possible to determine blood grouping and blood serology to establish compatibility with the recipient at the time of transfusion.

To carry out the sampling of the blood taken, bag systems comprising a sampling device as described in document EP-A1-1 389 473 are conventionally used. This sampling device comprises on the one hand a pocket of sampling intended to collect a portion of the blood taken and secondly a tube guide provided with a needle, connected to said sampling bag and in which there is inserted a vacuum tube Vacutainer type to collect the samples.

These systems require inserting the vacuum tube into the tube guide, which is a time-generating operation and may lead to a risk of misidentification don / sample.

WO 99/58094 proposes to connect directly to the bag a molded-blown sampling pear which can be pressed by hand to perform the sampling. After sampling, the pear is separated from the pouch and cut open to allow access to the sample for analysis. The opening of the pear therefore requires to have available a cutting instrument. On the other hand, this cut is a delicate operation generating a risk of contaminating the manipulator with the blood sample and imposing to clean the cutting instrument between two cuts to avoid cross contamination. The invention proposes to remedy these drawbacks by proposing a bag system comprising an integrated sampling container which can be opened easily and can be directly placed in an analysis automaton or in a centrifuge.

For this purpose and according to a first aspect, the invention proposes a bag system for receiving and sampling a biological fluid or one of its components comprising: at least one bag intended to receive the biological fluid or one of its components, and - at least one sampling container in fluid communication with said bag so as to be able to receive a sample of the fluid contained in said bag, said sample container being provided with a port for access to the bag; sample and comprising an opening device mounted in said port of the container, said opening device having a zone of weakness arranged to be broken so as to allow access to the sample via the orifice of said container.

According to a second aspect, the invention relates to a method for sampling a biological fluid or one of its components using a bag system according to the first aspect of the invention, said method comprising: - receiving fluid in the pocket; introducing a sample of fluid into the sampling container; the opening of the sampling container by breaking the zone of weakness of the opening device; and - access to the sample through the orifice of said container.

Other objects and advantages will become apparent from the following description.

Figure 1 schematically shows a bag system according to the invention with a sampling container according to a first embodiment.

Figures 2 and 3 schematically show the sample container of Figure 1 separated from the bag, before and after breaking the weak zone of the sampling vessel opening device, respectively.

Figure 4 schematically shows a bag system according to the invention with a sampling container according to another embodiment.

Figures 5 and 6 schematically show the sample container of Figure 4 separated from the bag, before and after breaking the fragility zone of the sampling vessel opening device, respectively.

Figures 7 and 8 schematically show a variant of the sampling container of Figure 4, separated from the bag, before and after breaking the weak zone of the opening device of the sampling container, respectively.

Figures 9 and 10 show schematically an embodiment of the sampling container in which the opening device is disposed within the container, before and after breaking of the fragile zone of the opening device, respectively.

Fig. 11 schematically shows a bag system according to the invention, wherein the sample container comprises a tubing connection member and a single piece opening device. Figure 12 schematically shows the sampling container of Figure 11 in which the zone of weakness of the opening device of the sampling container is broken.

Fig. 13 schematically shows a bag system according to the invention comprising a plurality of sampling containers.

A pouch system for receiving and sampling a biological fluid or one of its components. In particular, the biological fluid 4 is blood or a blood component such as a red blood cell concentrate, a plasma, a platelet concentrate or a buffy coat.

According to FIG. 1, the bag system 1 comprises: - a bag 2 intended to receive the biological fluid or one of its components, and a sampling container 3 in fluid communication with said bag 2 so as to be able to receive a sample of the fluid contained in said pocket.

The bag 2 and the sampling container 3 are in particular made of biocompatible thermoplastic material, flexible or semi-rigid, and sterilizable such as polyvinyl chloride or a polyolefin. For example, the bag has a container of between 50m1 and 1L, more particularly between 100 and 500ml.

In particular, the sampling container 3 is semi-rigid so as to allow by manual pressure the introduction of the sample into said container. The container 3 is then used as a pump to transfer a portion of the fluid contained in the bag 2 to the sampling container 3. Such a semi-rigid container 3 can be made by blow molding.

The sampling container 3 is provided with an access port 4 to the sample, making it possible, for example, to take a part of the sample for analysis.

The capacity of the sampling container depends on the nature of the sample and the analysis to be performed. For example, the container has a capacity of between 0.1 and 10 mL, especially between 1 and 5 mL.

For example, the sampling container 3 is a tube intended to be placed directly in an automaton in immuno-hematology or in a centrifuge. The dimensions of the tube are advantageously close to or identical to those of conventional sampling tubes Vacutainer type.

The sampling container 3 comprises in particular a flat or rounded bottom. A container 3 with a flat bottom has the advantage of being able to be raised vertically in a relatively stable manner, for example in an automaton in immuno-hematology. Thus, the needle of the automaton easily penetrates into the access port 4 of the container 3.

In addition, according to a particular embodiment not shown, the sampling container 3 comprises a graduated scale for determining the amount of fluid sampled in said container. According to FIG. 1, a tubing 5 is connected on the one hand to the sampling container 3 via a connecting element 6 and on the other hand to an orifice 7 of the bag 2, so as to allow the fluidic communication between said container 3 and said bag 2. To carry out sampling, the bag 2 is disposed above the sampling container. By manual pressure on the sampling container 3, the sample is then introduced into this container. To do this, the length of the tubing 5 is determined so that, during the pressure on the container 3, the air contained in the tubing 5 and in a part of the sampling container 3 is driven into the pocket 2 and replaced by fluid to be sampled.

The length of the tubing 5 is for example between 1 and 5 cm, in particular between 2 and 3 cm.

Alternatively, the tubing 5 is compressed using a stripper to drive air into the bag 2 and transfer a fluid sample into the container. 3

This tubing 5 is advantageously provided with a selective opening / closing device 8 for the fluidic communication through said tubing 5. Such a selective device 8 is for example a circuit-breaker or a clamp.10 In the case where the pocket 2 contains an additive and / or anticoagulant solution, it is possible that during sterilization and / or transport, part of the additive and / or anticoagulant solution passes into the sampling vessel 3.

This passage of the additive and / or anticoagulant solution of the bag 2 in the sampling container 3 implies having to carry out the re-transfer of this part of the solution into the bag 2 so as not to distort the solution / biological fluid ratio. in the pocket 2, and / or analyzes of the fluid sample contained in the container 3.

The presence of a selective open / close device 8, closed before sampling the content of the pocket, avoids this disadvantage.

According to the invention and in connection with FIGS. 1 to 12, the sampling container 3 comprises an opening device 9 mounted in the orifice 4 of the container 3, said opening device 9 having a zone of weakness 10 arranged to be broken so as to allow access to the sample through the orifice 4 of said container 3.

According to a first embodiment shown in FIGS. 1 to 8 and 11-12, the opening device 9 comprises a tubular body 11 on which the zone of weakness 10 is arranged.

In particular, when the container is a tube, the tubular body 11 has an inside diameter that is smaller than the inside diameter of the sampling container 3. After breaking the zone of weakness 10, access to the inside of the tube is relatively small, reducing the risk of sample spillage outside the tube.

According to FIGS. 1 to 8, the tubular body 11 extends outwards from the access orifice 4 of the sampling container 3.

The zone of weakness 10 is for example a zone of smaller thickness than that of the tubular body 11.

In particular, the zone of weakness 10 is arranged to be broken by a manual action, such as manual pressure, torsion or rotation of the tubular body 11. Thus, no particular tool is necessary to obtain access to the sample and the opening of the container 3 is easily achieved.

According to FIGS. 2, 3, 5 to 8, one end of the tubular body 11 has a hollow base 12 mounted in the access orifice 4 of the sampling container 3. The other end 13 of the tubular body is closed, so as to plug the access port of the container.

The opening device 9 is formed in particular from a single unitary part. It is made of thermoplastic material, advantageously rigid or semi-rigid, and sterilizable, such as polycarbonate, a polyolefin or polyvinyl chloride. It is for example formed by molding.

In FIGS. 5 to 8, the tubular body 11 further comprises at least one or more gripping elements 14 arranged to facilitate the grip of the opening device 9 with a view to breaking the zone of weakness 10.

In particular, the gripping elements are disposed on the end 13 of the tubular body not mounted in the orifice 4 of the sampling container. For example, the gripping members 14 are formed by a substantially flat member.

According to FIGS. 5 and 6, the gripping elements 14 are formed of at least two lateral elements disposed on either side of the tubular body at the end 13 not mounted in the access opening 4 of the sampling container. These lateral elements are in particular substantially flat and of trapezoidal shape. The rupture of the zone of weakness is carried out by exerting a pressure or a rotational movement on the end 13 of the tubular body 11 not mounted in the orifice of FIG. access 4 of the sampling container 3.

According to FIGS. 7 and 8, another pair of lateral elements is disposed between the zone of weakness 10 and the base 12 of the opening device 9.

According to a variant, the opening device comprises a sealing membrane disposed between the orifice 4 of the sampling container 3 and the zone of weakness 10 of the opening device 9.

This sealing membrane is for example formed of a film of thermoplastic material of small thickness.

During the breaking of the zone of weakness 10, the orifice 4 of the sample is therefore closed by this sealing membrane. Thus, in case of mishandling of the container 3, the fluid contained in the container can not spread outside and possibly contaminate the manipulator.

This membrane advantageously has a sufficiently small thickness to be easily pierced, in particular by the needle of an analysis automaton.

According to a variant shown in FIGS. 9 and 10, the opening device 9 is placed inside the sampling container 3. In order to break the zone of weakness 10, the sampling container 3 is then advantageously made of a sufficiently flexible material to allow the zone 10 to break by external manipulation.

According to FIGS. 9 and 10, the opening device 9 is formed of a solid rod 15, one end of which extends inside the container and whose other end comprises the zone of weakness 10 and is provided with a base 12 mounted in the orifice 4 of the container 3. The zone of weakness 10 is broken manually by exerting a pressure on the rod 15. 9 In particular and in connection with FIGS. 9 and 10, once separated from the the remainder of the bag system 1, the sampling container 3 is disposed directly in an analysis automaton provided with a needle 16 for taking a part of the sample. In this case, the descent of the needle 16 of the analysis automaton automatically causes the zone of weakness 10 of the opening device 9 to break. The needle 16 of the automaton then reaches the inside of the container 3.

In these different embodiments of opening devices, the sampling container 3 is connected to the bag 2 via a tubing 5. In particular, the tubing is connected to the sampling container via a connection element 6 distinct from the opening device 9.

For example, the connection element 6 is a connector mounted in an opening made in a wall or a bottom of the container 3 and in which the pipe 5 is inserted and held by gluing or welding.

According to Figures 1 to 8, when the sampling container 3 is in the form of a tube, the connecting member 6 is disposed opposite the access port 4 of the tube.

In the embodiments of Figures 1 to 8, the container 3 is separated from the rest of the bag system 1 by welding the tubing, in particular by high frequency welding. However, the remaining portion of the tubing 5 can prevent the sampling container 3 from being arranged vertically in the analysis automaton, the needle of the automaton then being unable to penetrate through the access orifice 4 of the container 3.

Before the introduction of the container into the automaton, it can then be expected to mount the container 3 on a support to keep it upright. Alternatively, the support is integrated in the sampling container 3 and is arranged to cover the weld. For example, when the container 3 is a tube, the support is formed of a ring movable by friction along the tube and arranged to slide between an initial position in which the ring is arranged around the tube and a support position. wherein the ring covers the weld of the tubing. Alternatively, the support is formed of a semi-rigid ring disposed at the connection element of the container, foldable on the weld of the tubing.

According to an alternative embodiment illustrated in FIGS. 11 to 13, the connection element 6 and the opening device 9 of the sampling container form a single piece 17.

The part 17 forming the connection element to a tubular and the opening device of the sampling container is formed of a tubular body 11 on which is arranged the zone of weakness 10. One of the ends of the tubular body is provided with a hollow base 12 mounted in the access port 4 of the sampling container 3. The other end 13 of the opening device has an opening 18 forming a connection element and in which the tubing 5 is inserted. connecting the bag 2 to the container 3. As in the embodiments of Figures 5 to 8, the tubular body 11 is advantageously provided with gripping elements 14 facilitating the grip and rupture of the zone of weakness 10. In particular, the The gripping elements 14 are in the form of one or two pairs of lateral elements disposed on either side of the tubular body 11, facilitating the rupture of the zone of weakness 10 by rotation.

In connection with FIG. 13, the bag system 1 comprises a main collection bag 19 in fluid communication with a donor blood collection device such as a needle 20. The main bag 19 is connected to a subassembly. set of secondary pockets 21,22,23 intended to contain the blood or a blood component obtained after centrifugation of the whole blood. The subset may include one or more filtration units 24 for filtering blood or a blood component. Depending on the fluid to be sampled, the sampling vessel 3 is in fluid communication with the main collection pocket 19 or one of the secondary pockets 21,22,23. As illustrated in FIG. 13, the bag system 1 may contain one or more sampling containers 3. In a variant that is not shown, one and the same pocket is in fluid communication with a plurality of sampling containers 3 making it possible to produce samples. the same fluid at different times.

Advantageously, the bag system 1 is in closed system, that is to say that the various components of the system are pre-connected manufacturing. In particular, the fluidic exchanges between the bag 2 and the sampling container 3 are made sterile, without contact with the ambient air.

The pre-connection of the sampling container 3 to the bag 2 intended to contain the fluid to be sampled makes it possible to identify with certainty, for example by means of labels affixed at the time of manufacture or at the time of manufacture. sampling, the source of the sample taken.

The pre-connection also makes it possible to sterilize at the same time the sampling container 3 and the bags 2, so as to obtain a sterile pouch system ready for use and sampling.

According to a second aspect, the invention relates to a method for sampling a biological fluid or one of its components using the bag system 1 as described above. The sampling method comprises introducing a sample of fluid into the sampling vessel 3; Opening the sampling container 3 by breaking the zone of weakness of the opening device 9; - access to the sample via the orifice 4 of said container 3.

The introduction of the sample is carried out by stripping the tubing, manual pressure (s) on the sampling container 3, and / or gravity by placing the bag 2 containing the fluid at the top of the container. sampling 3.

The opening of the container 3 is made by rotation or pressure on the zone of weakness 10 of the opening device 9 of the container 3 to break it. After opening the container 3, the sample is accessible via the orifice 4 of said container. In particular, the needle of an immunohematology machine can freely and easily penetrate inside the container 3 to take a part of the sample.

Prior to or in conjunction with the step of opening the sampling container 3, the method comprises a step of separating said container 3 from the bag 2. For example, the separation is carried out, after filling of the sampling container 3, by welding with a high frequency welder tubing 5 connecting the bag 2 to the container 3. Advantageously, the weld is made as close as possible to the container 3. After the separation of the sampling container 3, this- it is arranged so as to place the opening device 9 upwards, then the zone of weakness 10 is broken to access the sample. In a variant, when the connecting element 6 and the opening device 9 form a single piece 17, the rupture of the zone of weakness 10 allows not only access to the sample, but also separation of the container from the container. sampling 3 from the remainder of the bag system 1 or the portion of the tubing 5 placing in fluid communication the bag 2 and the sample container 3 if this tubing has been previously welded.

When the sampling container 3 is open, it is placed directly in an analysis automaton for sampling and analysis of a part of the sample.

Claims (15)

REVENDICATIONS1. A bag system (1) for receiving and sampling a biological fluid or a component thereof comprising: at least one bag (2) for receiving the biological fluid or one of its components, and at least one container sample (3) in fluid communication with said bag so as to be able to receive a sample of the fluid contained in said bag, said sample container (3) being provided with an access port (4) to the sample , said system being characterized in that said sampling vessel (3) comprises an opening device (9) mounted in said opening (4) of the vessel, said opening device (9) having an area of weakness (10). ) arranged to be broken so as to allow access to the sample through the orifice (4) of said container. Pouch system (1) according to Claim 1, characterized in that a pipe (5) is connected on the one hand to the sampling vessel (3) via a connection element (6). and on the other hand to an orifice (7) of the bag (2), so as to allow fluid communication between said container (3) and said bag (2). 3. Bag system (1) according to claim 2, characterized in that the connecting element (6) is distinct from the opening device (9). Pouch system (1) according to claim 3, characterized in that the opening device (9) comprises a sealing membrane arranged between the orifice (4) of the sampling container and the zone of weakness ( 10) of the opening device (9). 5. Bag system (1) according to claim 2, characterized in that the connecting element (6) and the opening device (9) of the sampling container (3) form a single piece (17). 30 15 6. Bag system (1) according to any one of claims 1 to 5, characterized in that the zone of weakness (10) is arranged to be broken by a manual action. 7. System bag (1) according to claim 6, characterized in that the opening device (9) comprises a tubular body (11) on which is arranged the zone of weakness (10), the tubular body further comprising one or more gripping elements (14) arranged to facilitate the grip of the opening device (9) with a view to breaking the zone of weakness (10). Pocket system (1) according to one of Claims 1 to 7, characterized in that the sampling container (3) is a tube. The bag system (1) according to claims 7 and 8, characterized in that the tubular body (11) has an inside diameter which is smaller than the inside diameter of the sampling container (3). Pouch system (1) according to one of Claims 1 to 9, characterized in that the sampling container (3) comprises a flat bottom. 11. Bag system (1) according to any one of claims 1 to 10 characterized in that the sampling container (3) is semi-rigid so as to allow manual pressure introduction of the sample into said Container (3). A bag system (1) according to any one of claims 1 to 11, characterized in that the sampling container (3) comprises a graduated scale for determining the amount of fluid sampled in said container (3). 16 13. Bag system (1) according to any one of claims 2 to 12, characterized in that the tubing (5) is provided with a selective device (8) for opening / closing the fluid communication through said tubing. A method for sampling a biological fluid or one of its components using a bag system (1) according to any one of claims 1 to 13, comprising: receiving the fluid in the bag (2 ); introducing a fluid sample into the sampling container (3); opening the sampling container (3) by breaking the zone of weakness (10) of the opening device (9); access to the sample through the orifice (4) of said container (3). 15. Method according to claim 14, characterized in that it comprises, before or together with the step of opening the sampling container (3), a step of separating said container (3) from the bag (2). .