FR2655532A1 - Device for taking a sample for a blood sample collection - Google Patents

Abstract

This device for taking a blood sample using a vacuum tube (14) is positioned in a tubing (5) connecting a hypodermic needle (2) to a blood container (4). It is characterised in that it comprises: - a Y-shaped branch connection piece (7) interposed in the tubing (5) between the needle (2) and the container (4), - a circuit opener (10) arranged in the lateral branch (11) of the connection piece (7) and equipped with breakable opening means, - an adapter (13) for a vacuum tube (14) arranged in series with the circuit opener (10) and comprising means for establishing communication with the vacuum tube (14). The invention is applicable to medical equipment.

Description

 The present invention relates to a device for taking a blood sample by vacuum tube, from a flexible tube connecting a needle for pricking a donor vein to a container for collecting blood, generally a set of plastic bags. suitable for collecting and storing human blood.

 Currently, the units of blood taken from these plastic bags or even from glass vials are necessarily accompanied by taking samples intended for the practice of control examination. Indeed, it is essential to know the exact nature of the blood collected before storage and use, by control examinations. The taking of samples presents a certain number of risks, in particular for the personnel taking the samples, but also for the patient and the environment. Indeed, such manipulations present a significant risk of viral contamination by injection or by projection of blood. In addition, it is necessary to ensure the sterility of the therapeutic or diagnostic unit of blood.

 It is known to take samples by cutting the flexible tubing connecting the donor's vein pricking needle to the blood collection container, in order to fill open tubes. Such a practice presents not only the risk of blood projection and contamination for the personnel but also the risk of air flow back into the bloodstream of the donor. In addition, the filling level of the tubes is poorly standardized.

To avoid such drawbacks, it is also currently known to use the needle after cutting out to directly fill the vacuum tubes, by piercing # with the needle itself, a tight closure cap for these tubes. But the vein needle being of a caliber unsuitable for this practice, the piercing of the tube plug is very laborious and there follows a non-negligible risk of accidental puncture by personnel
In addition, the blood drawn under such conditions does not come directly from the circulation of the donor but from the donation previously carried out, and this also calls into question the quality of the sample.

 It has also been proposed to take samples in vacuum tubes from the flexible tubing connecting the vein needle to the container. For this, a fitting is interposed in the tubing, a bypass of which comprises a closure cap constituted by a flexible membrane defining a site suitable for sampling. The latter is carried out using a vacuum tube adapter, comprising a double needle, one end of which is capable, at the time of taking the samples, of perforating the seal of the fitting, while the other end is capable of piercing a protective latex cap, pushed back during the introduction of said double needle into the vacuum tube, by the very cap of the latter, which it passes through.

 This device is not entirely satisfactory either, because the risk of blood projection remains during the perforation of the seal of the connector which is carried out in the open air, externally to the tubing.

In addition, it requires the use of a double needle, that is to say having two perforating sides, and therefore a higher cost price than a single needle. Another disadvantage also resides in the fact of having to manage additional consumable auxiliary material, and also to increase the number of manipulations of this material, in this case the vacuum tube and the adapter.

 In a variant of the previous system, the sampling site is replaced by a female conical tip; a vacuum tube adapter of the male-needle conical tip type is then used. This solution has the same drawbacks as the previous one.

 The object of the present invention is to remedy these various drawbacks by proposing a device for taking a sample which can be integrated, at the manufacturing stage, into the blood collection and preservation equipment.

To this end, it relates to a device for taking a blood sample by vacuum tube, from a flexible tube connecting a needle for pricking the vein of a donor to a container for collecting blood, characterized in that '' he understands successively
- a Y-shaped branch fitting, two opposite branches of which are intended to be connected respectfully to a segment of tubing terminated by the needle and to a segment of tubing connected to the container,
- a circuit opener, initially closed, arranged in a lateral branch of the connector forming a bypass, and comprising frangible opening means
- a vacuum tube adapter, closing the end of the bypass and comprising in series means for putting it in communication with the interior of a vacuum tube, when mounting the latter on said adapter beforehand when opening the circuit breaker
The vacuum tubes can thus be filled with blood coming directly and without discontinuity from the circulatory system of the donor, and this:
-without additional phlebotomy,
- without any additional consumable material other than vacuum tubes,
- without any risk of accidental sting for the personnel, the circuit opening being done internally, in the bypass,
-Without questioning the sterility of the unit at any time.

The present invention also relates to the characteristics below, considered in isolation or according to all their possible technical combinations
According to another characteristic of the invention, the frangible opening means of the circuit-breaker consist of a tubular element comprising at least one part forming a tight plug in the branch, and into which opens one end of a conduit internally, the other end of the latter being initially closed, so that a break in the tubular element by bending through the fitting, puts the tubing in communication with the vacuum tube adapter
According to a preferred embodiment of the invention, the tubular element of the circuit breaker comprises a thinned part in the form of a hollow appendage connected to the stopper by means of a canvas, intended to be broken by folding of said appendage relative to the plug
According to another characteristic of the invention, the frangible appendage of the circuit breaker is directed towards the vacuum tube adapter
According to another characteristic of the invention, the appendage and the plug are obtained during the same operation of molding a brittle plastic material.

According to another characteristic of the invention, the means for bringing the vacuum tube adapter into communication are constituted by a stopper pin of the end of the branch of the Y connector, pin in which is inserted and opens the base of a needle, which has a protective latex cap at its free end, retractable simultaneously with the introduction of the adapter needle into the cap of a vacuum tube
According to another characteristic of the invention, the adapter includes a protective cover for the needle and its latex cap.

According to one embodiment of the invention, the needle protection cover is screwed into an outer base of the shutter pin
According to another embodiment of the invention, the needle protection cover is fixed to the shutter pin by wedge effect of two corresponding parts
According to yet another embodiment of the invention, the protective cover is fixed to an external base of the shutter pin by at least one part of the fabric which is frangible by tearing off.

 Finally, according to another characteristic of the invention, a pump body is capable of replacing the protective cover of the needle of the adapter instead of said cover by corresponding fixing means, and in which body a vacuum tube is intended to be engaged against the needle of the adapter, under a latex cap, which it repels when the tube is engaged in said pump body.

The invention will be further illustrated without being in any way limited by the description which follows, given with reference to the appended drawings in which
Figure 1 shows an axial sectional view of a blood sample taking device according to the invention, before use, and on an enlarged scale compared to the collection and conservation equipment;
Figure 2 shows a view, according to Figure 1, of the device of the invention, while taking a blood sample
FIG. 1 represents a collection assembly 1 designated globally, and allowing the collection of blood from a pricking needle 2 capable of perforating the vein of a donor, for example of an arm 3. The needle 3 is connected to a container 4 for collecting blood by means of a tube 5 connected on the one hand to the needle 2 and on the other hand to the container 4.

According to the invention, a blood sample taking device 6, designated as a whole, is interposed in the tubing 5
It consists of a Y-shaped branch connector 7 of which two opposite branches 8 and 9 are connected in a sealed manner respectively to a segment of tubing Sa terminated at its end by the needle 2, and to another segment of tubing 5b connected at its end to the container 4.

 A circuit opener 10, initially closed, is arranged in a lateral branch 11 of the connector 7, forming the bypass, and includes frangible opening means 12.

 An adapter 13 allows subsequent mounting, when taking the sample, of a vacuum tube 14 known per se. The adapter 13 closes off the end of the branch or lateral branch 11 and includes means for placing said branch 11 in communication with said vacuum tube 14, during assembly of the latter, prior to the opening of the circuit, by manual action on the circuit breaker 10.

 According to a characteristic of the invention, the frangible opening means 12 consist of a tubular element comprising a part forming a plug capable of sealing between the tubing 5 in general and the adapter 13 of tube under vacuum 14. In the plug 16 there opens an open end 17a of an internal conduit 17, the other end 17b of the latter being initially closed (FIG. 1). This is the break, by manual pressure or by bending, through of the flexible material constituting the branch 11, of the tubular element 15 which places the tubing 5 in communication with the adapter 13 of the vacuum tube (14).

According to one embodiment of the tubular element 15, the latter comprises a thinned part in the form of an appendage 18 relative to the plug 16 and connected to the latter by means of a canvas 19, which can be torn off by folding said appendix 18 relative to the plug 16. This folding takes place through the lateral branch 11, produced with the connector 7 made of flexible plastic. The frangible appendage 18 is directed towards the adapter 13 according to a preferred embodiment. Indeed, in this way it remains trapped in the branch 11, while if it was directed in the opposite direction, it could dangerously circulate in the tube 5 or close it at least partially. Preferably, the appendix 18 and the plug 16 are made in one piece obtained during the same operation of molding a brittle plastic material
Appendix 18 can also include a peripheral fracture leader (not shown) so as to make it more easily frangible
According to a characteristic of the invention, the means for placing the adapter 13 of the vacuum tube 14 in communication are constituted by a pin 20 sealing the end Ila of the branch 11 and secured to the latter, for example by bonding. A single needle 21, that is to say a single perforating part 22, is inserted by its base 21a into the pin 20 in which it opens facing a conduit 23 in communication with the lateral branch ll , or more precisely with a chamber 24 initially closed and empty, delimited between the plug 16 and the pin 20.

The perforating part 22, defined by the free end of the needle 21, is provided with a retractable waterproof protective cap 25, made of latex
The pin 20 has a free part or base 20a capable of receiving a rigid protective cover 26 of the needle 21. The cover 26 is fixed to the part 20a of the pin 20 by screwing corresponding threaded parts (not visible).

 For ease of execution of the parts to be assembled 26, 20a, these have corresponding flared parts to provide a wedge effect (not visible).

 An alternative embodiment of these same parts 26, 20a consists in making them assembled to one another by the same molding operation, the connection between them being ensured by peripheral fabric parts (not visible) produced at their bases. respective, and frangible by tearing, exercised manually.

 The implementation of the device for taking a blood sample according to the invention, described above, that is to say when the blood sample is completed, is carried out after having isolated the container 4 filled with the blood collected. , relative to the needle 2 still in place in the arm 3 of the donor, by means of a knot made on the section of tubing 5b or a tight clamp, on this section 5b.

The protective cover 26 of the needle 21 of the adapter 13 is then removed either by unscrewing or by breaking as appropriate, so as to mount on the adapter 13 a pump body 27, (see FIG. 2). substituting for said cover 26 in its place and place, by means of corresponding fixing means; for this purpose, this body 27 has fixing means similar, if not identical to those of the cover 26, and complementary to the fixing means provided on the base 20a of the pin 20, in order to allow the fixing of the cover 26 either successively of the body 27 on the pin 20, except when the cover 26 is initially fixed to the pin 20 by frangible means
In the latter case, the body 27 can still be mounted on the pin 20, without this being essential for the cover 26, after its separation from the pin 20. The body 27 thus put in place, slides the vacuum tube 14 including a puncture-resistant stopper 28, made of rubbery material, engages by pushing on the needle 21 while simultaneously pushing the protective cap 25 in latex, which thus gradually uncovers the needle 21 coming out into the tube 14 (FIG. 2) .

 The open-circuit 10 is then broken by manual action on the appendage 18 of the tubular element 15, through the branch 11 of the connector 7, thus putting the blood fluid present in the tubing 5 into communication with the tube under vacuum 14, via the pin 20 and the needle 21, in order to constitute a sample in the tube 14. The flow thus authorized takes place well away from any contamination and without any risk of projection or sting. When the tube 14 is filled, it is extracted from the pump body 27. The protective cap 25 then resumes its place elastically around the needle 21 to prevent any flow or oozing of blood and the rubbery material of the stopper 28 of the tube 14 tightens on itself simultaneously with the extraction of the needle 21 , to seal said tube 14 containing the blood sample taken.

The pump body 27 is then recovered and the tubing destroyed. As for the container 4 and the tube 14, they are sent to the processing and analysis laboratories
The reference signs inserted after the technical characteristics mentioned in the claims, have the sole purpose of facilitating the understanding of the latter, and in no way limit their scope.

Claims (10)

 1. Device for taking blood samples by vacuum tube (14), from a flexible tube (4) connecting a needle (2) for pricking a donor's vein to a container (4) for collecting of blood, characterized in that it successively comprises:  - a Y-shaped branch fitting (7), two opposite branches (8,9) of which are intended to be connected respectively to a segment of tubing (5a) terminated by the needle (2) and to a segment of tubing (5b) connected to the container (4),  - a circuit opener (10), initially closed, arranged in a lateral branch (11) of the connector (7) forming a bypass and comprising frangible opening means (12)  - an adapter (13) of the vacuum tube (14) closing the end of the bypass (11) and comprising in series means for putting it in communication with the interior of said vacuum tube (14), during mounting the latter on said adapter, prior to opening the circuit breaker  2. Device according to claim 1, characterized in that the frangible opening means (12) of the circuit opener (10) consist of a tubular element (15) comprising at least one part forming a tight plug (16 ) in the branch (11), and into which opens one end (l7a) of an internal conduit (17), the other end (17b) thereof being initially closed, so that a break in the tubular element by folding through the fitting, connects the tubing (5) with the vacuum tube adapter (13) (14)  3.A device according to claims 1 and 2, characterized in that the tubular element (15) of the circuit breaker (10) comprises a thinned part in the form of a hollow appendage (18) connected to the plug via a canvas (19), intended to be broken by folding said appendage (18) relative to the plug (16)  4.Device according to one of the preceding claims, characterized in that the frangible appendage (18) of the circuit opener (10) is directed towards the adapter (13) of the vacuum tube (14).  5. Device according to one of the preceding claims, characterized in that the appendix (18) and the plug (16) are obtained during the same operation of molding a brittle plastic material.  6. Device according to claim 1, characterized in that the means for placing the adapter (13) of the vacuum tube (14) in communication are constituted by a pin (20) for closing the end (lla) of the bypass (11) of the Y connector, pin into which the base (24a) is inserted and opens a needle (21) which is provided at its free end (22), with a latex protective cap ( 25) retractable simultaneously with the introduction of the needle (21) of the adapter (13) into the cap of a vacuum tube (14)  7. Device according to claims 1 and 6, characterized in that the adapter (13) comprises a protective cover (26) of the needle (21)  8. Device according to claim 7, characterized in that the protective cover (26) of the needle (21) is screwed into an outer base (20a) of the shutter pin (20).  9. Device according to claim 7, characterized in that the protective cover (26) of the needle (21) is fixed on the shutter pin (20) by the wedge effect of two corresponding parts.  10. Device according to claim 7, characterized in that the protective cover (26) is fixed to an external base (20a) of the shutter pin (20) by at least a part of frangible canvas by tearing.  11. Device according to any one of the preceding claims, characterized in that a pump body (27) is capable of replacing the protective cover (26) of the needle (21) of the adapter (13) in place of said cover (26) by corresponding fixing means, and in which body (27) a vacuum tube (14) is intended to be engaged against the needle (21) of the adapter (13) under a latex cap (25), which it repels upon the engagement of said tube (14) in said pump body (27).