Device for sampling physiological fluids, in particular blood, and receptacle therefor.

p0001The present invention relates to a body fluid sampling system, such as blood, and more particularly to a sytem for the sampling of small volume, and a container for such a system.

p0002In known manner, the blood sample, especially in view of the constitution of-samples is performed using a needle syringe, the traction of the piston causing the suction of blood in the body of the syringe.

p0003In the case where the amount of blood collected is intended to undergo analysis or testing operations; one must in a known manner, to transfer the volume of blood contained in the body of the syringe in one or more containers depending on the number of operations to be performed.

p0004This transfer leads to risks of contamination (eg, hepatitis) of the operator by the possibly infected blood with the serious consequences that this implies. This risk of contamination is even higher than the number of tests, so different containers is greater.

p0005In addition, this transfer of blood collected, the body of the syringe into the container or containers, may lead to errors or problems of manipulation, especially in the case of small volumes.

p0006Moreover, thanks to the improvements of techniques and blood analysis equipment, we can now obtain satisfactory analysis and testing from very small amounts of blood (a few mm3). In many cases, it may draw sufficient blood by the capillary method (finger tip, ear, etc ...), which uses capillary tubes. The content of these tubes after sample must be transferred to another container for analysis. It is understood that it is very difficult to collect and transfer accurately from small volumes of blood with a conventional syringe, and that this is even possible with very small volumes.

p0007To overcome these drawbacks, it has already described in European Patent Application EP-Am 0,055,657 a blood sampling system (both capillary and venous) of simple implementation, for obtaining a blood volume low and exactly corresponding to the desired amount, the risk of contamination is limited, because the blood sample is introduced into the container which is directly used to perform analyzes and tests envisaged.

p0008This physiological fluid sampling system, such as blood, includes means for manual or mechanical suction, such as a syringe provided with a cylinder and a needle, and is characterized in that it comprises at least a tubular container of small diameter capable of being removably held in the extension of the cylinder, on the side of the needle, by retaining means carried by said cylinder, so that the bottom of said container is traversed in a sealed manner said needle, said container being provided with a cap closing its end opposite said needle and provided with a take-off member of said liquid.

p0009It is seen that, in this system, said needle serves as a connection between the suction means and the container when the latter is held by the holding means and the needle passes through the bottom of said container, enabling means suction to suck air contained in the container and force the liquid fed by the pickup member to enter said container, despite the small diameter thereof.

p0010Thus, with this system avoids the risk of contamination since the collected blood passes directly from the patient into the container that will be used to perform the necessary analysis or testing.

p0011During suction of blood by the suction means in the cylinder, it is of course necessary that the container bottom is traversed by the needle of said suction means sealingly. The background should also be sealed when the latter is separated suction means to perform the analyzes; ie the blood contained must not get out of said container.

p0012For this purpose, the container bottom comprises a partition, recessed from the lower end of said container, which is provided with a sufficiently large diameter of light to allow passage of the needle suction means and against which s applies a flexible membrane of an elastic material such as rubber, arranged on the outer side of the partition and intended to be pierced by said needle, said membrane having sufficient elasticity to enable, after removal of the needle, sealing of the opening created by the insertion of said needle.

p0013Thereby obtaining the sealing both when the needle suction means passes through the membrane, when said needle is withdrawn, at the désoli- darisation container and said suction means.

p0014However, the system described in EP-A1-0 055 657 has proved a delicate use. Indeed, upon actuation of the suction means putting in depression the tubular container, it was found that these suction means not only suck air of the tubular container, thus allowing it to fill of blood, but the blood penetrates into said container. These are then contaminated and can not be used for another levy. In a sudden operation of said suction means, it even happens that, like an arc, forms a blood flow, direct and continuous between the sampling member of the cap mounted on the container and needle suction means. Almost all of the blood from the donor then passes directly into the suction means.

p0015The present invention aims to overcome this disadvantage and to allow direct sampling small volumes of blood.

p0016To this end, according to the present invention, the physiological fluid sampling system, such as blood, comprising suction means and at least one container provided with a transverse partition disposed adjacent an end or closing the -ci and an orifice, while a taking member of said liquid is releasably connected to the other end of the container, is characterized in that the portion of said container between the wall and the end connected to said pickup member is designed as a cylinder for a piston disposed in said part and integral with a piston rod passing through said wall through said opening and accessible from outside said container, the side opposite to the opening member.

p0017Thus, by actuating said piston rod, it is possible to move the piston within the container and to suck inside thereof blood taken by the opening member. During filling the piston is seal relative to the internal wall of the container and the liquid can not pass from the other side of said piston. At the end of suction, the piston is applied against the inner wall and sealingly closes the opening of said partition.

p0018We see that with the system according to the invention avoids the drawback mentioned above about the previous system, in particular because it eliminates the external suction means, which are now incorporated into the container it -even.

p0019Preferably, said piston rod has an incipient fracture so that at the end of aspiration, can easily break the rod adjacent the container end opposite the pickup member and that the piston rod is not detrimental to the subsequent use and manipulation of the container, whose bottom is then formed by said partition and the piston.

p0020Moreover, the prior system described above has the additional drawback of allowing the blood sample in only one container at a time. However, many tests require to have available a number of separate samples. As a result, the previous system requires successively take several samples of blood from the patient, that is to say to prick several times with the needle generally used for sampling member. It is painful to use for the patient.

p0021The present invention overcomes this drawback another, providing that in the sampling system, several containers is arranged in parallel on a common sampling unit.

p0022The containers can be connected in parallel to similar or different dimensions according to the tests which are intended samples contained therein.

p0023Preferably, the system comprises a flexible conduit for example, one end of which is provided the opening member, the other end of the duct being provided with a plurality of branches, to each of which can be removably attaching a container. Each branch can be provided with shutter means, such as crushing clamps if the leads are flexible.

p0024Downstream of said leads, said leads can be connected, for example detachably, to a normal bag blood collection with a capacity of several hundred cm 3. It will be noted that such a system of the invention has a considerable advantage over the pocket collection devices known in use for blood donations. In effect, these known devices comprise a collection bag connected by a flexible conduit to a needle; Also, the manual of these devices is known, after bite of a patient's vein through the needle to drain the blood into the pocket until the desired amount is reached, then the remaining up needle into the vein, cut the conduit to isolate the pocket and collecting duct cut in test tubes, some blood samples to carry out the necessary checks on the characteristics of the donor's blood. We see that with these known devices, the verification samples may be collected only after filling of the bag. As a result, if the donor feels uneasy to bring about the immediate cessation of collection, the blood already collected part is unusable and must be discarded, since it will be impossible to carry out the verification tests. However, with the system according to the invention, if the donor is subject to discomfort, the amount of blood collected before the removal of the stop can be used, since the necessary samples have been collected at the beginning of sampling, in the containers of the invention.

p0025The figures of the appended drawings show how the invention can be achieved.<ul><li>Figure 1 is a longitudinal sectional view of a container for sampling system according to the invention.</li><li>2 shows an exemplary embodiment of the system according to the invention.</li></ul>

p0026The embodiment 1 of the container according to the invention for blood prélèvementt, shown in Figure 1, comprises a tubular body 2 provided with an internal transverse partition 3, an orifice through 4. In Figure 1 , the partition 3 is shown recessed with respect to the right end of the tubular body 2 so that this wall separates the internal volume of the body 2 in two-cavities 2a and 2b; however, this is not a requirement and the partition 3 may be at the end of this edge.

p0027The largest of the cavities, that is to say the cavity 2a, cylinder shape to a piston 5, for example constituted by a block of elastomer. The piston 5 is secured to a piston rod 6 which passes through the partition 3 by the orifice 4 and the end 6a, opposed to the piston 5, protrudes outside the tubular body 2, after passing through the cavity 2b, even when the piston 5 is in its furthest position of the partition 3.

p0028The piston rod 6 comprises a rupture initiation 7 located in the vicinity of the right end of the tubular body 2 (position 7 ') when the rod 6 is pulled all the way to the right, that is to say when the piston 5 is in abutment against the partition 3 (5 '). Thus, it is possible after having brought the piston 5 in the 5 'to break the piston rod 6 to remove the projecting part which could be troublesome.

p0029In the exemplary embodiment of the system according to the invention shown in Figure 2, there is provided a plurality of containers 1 similar to that of Figure 1 but of different sizes. This system comprises a flexible conduit 8 at one end of which is fixed a needle 9, covered with a protector 10.

p0030At the end of the duct 8 opposite to the needle 9, are arranged a plurality of branches 11 terminating in end caps 12, each of which is connected, for example by interlocking, a container 1. crushing tongs 13 are provided on the conduit 8 in the vicinity of the needle 9 and the lead 11. in addition, downstream of the lead 11, the duct 8 extends 8a to a blood donor collection bag (not shown) which is is soldered directly to the extension 8a, is connected thereto by means of a connector 14.

p0031For its storage and transport, the system of Figure 2, possibly increased by a blood donation collection bag, is enclosed in a sterile envelope 15.

p0032To use the system according to the invention, it is taken out of the housing 15 and introducing the needle 9, the protector has been removed, into the vein of a patient. By acting appropriately on the clamps 13 and on the pistons 5 of the containers 1 (by means of the rods 6) can be taken from said containers 1 and in the collection bag not shown the desired quantities of blood.

p0033Following collection, the containers 1 are disengaged ferrules 12 to separate the assembly and piston rods 6 are broken into 7.

p0034One then obtains a plurality of blood samples each contained in a container 1, the wall 3 and the piston 5 (bearing on it) forms the bottom.

p0035It is advantageous for the extreme position of the pistons 5 to the opening member 9 is limited by a stop (not shown), for example integral with connectors 12, to maintain said pistons 5 in the withdrawal of the corresponding end of the associated tube. Thus, it is possible to suck in each recess 2a a specified volume of blood, this volume being slightly less than the maximum capacity of said cavity, so that there is no risk of overflow.