Dispensing instrument equipped with a device to prevent tube removal

Abstract

The invention relates to a dispensing instrument (55) comprising: - an elongated body (13) having a cavity extending from a first end (15) to a second end (17), which body (13) further has an opening at the first end (15) and an orifice at the second end (17), - a needle (31) partially covered by a sleeve (33) and extending within the cavity, which needle (31) opens to the outside of the body (13) via the orifice, - a tube (7) closed by a stopper (9) and housed in the cavity such that the stopper (9) compresses the sleeve (33) and the needle (31) pierces the sleeve (33), passes through the stopper (9) and enters the tube (7), and - a member (11) arranged to prevent the withdrawal of the tube (7) by compensating for the restoring force exerted on the tube (7) by the sleeve (33). [Fig. 6]

Description

Title of the invention: Dispensing instrument provided with a member preventing tube withdrawal

[0001] The field of the invention relates to a dispensing instrument, in particular for the purposes of analyzing a sample of biological fluid.

[0002] Medical biology is a specialty that consists of analyzing biological fluids in order to determine the pathophysiological origin of a disease. A medical biology examination can also contribute to the prevention, screening, diagnosis or assessment of the risk of occurrence of pathological conditions, as well as the determination or monitoring of the physiological or pathophysiological state of a patient.

[0003] The biological fluid to be analyzed is, for example, blood, urine, cerebrospinal fluid, pleural fluid or synovial fluid.

[0004] A medical biology examination generally takes place in three phases: - a pre-analytical phase, which includes the collection of a sample of biological fluid from the patient, as well as the preparation, transport and storage of the sample; - an analytical phase, which corresponds to the technical process enabling the obtaining of a biological analysis result; and - a post-analytical phase, which corresponds to the contextual interpretation of the result.

[0005] During the pre-analytical phase, it is known to use a sampling instrument formed by the assembly of a sampling body, a Simple Luer adapter and a tube.

[0006] The sampling body is an elongated body having a first end and a second end between which a cavity extends. The sampling body has, at the first end, an opening for the introduction of a tube into the cavity as well as a pair of flanges for gripping the sampling body, and, at the second end, a threaded orifice for mounting the Single Luer adapter on the sampling body. The sampling body is for example a BD Vacutainer sampling body (registered trademark of the company Becton, Dickinson and Company).

[0007] The Single Luer adapter comprises a male Single Luer fitting, an external thread and a needle covered with a sleeve. The Single Luer adapter is mounted on the sampling body by means of the external thread, which is complementary to the threaded orifice, such that the needle extends inside the cavity and the male Single Luer fitting extends outside the cavity.

[0008] Finally, the tube, closed by a stopper, is introduced into the cavity via the opening of such that the stopper exerts pressure on the needle, which pressure allows the needle to pierce the sleeve and pierce the stopper to penetrate the tube. The tube is pushed into the cavity until the stopper compresses the sleeve against the inner wall of the sampling body at the second end.

[0009] The sampling instrument can be coupled, by means of the Single Luer adapter, to a tube connected to a sampling needle, which makes it possible to guide a sample of biological fluid into the tube. Once filled, the tube can be removed from the sampling body and then replaced by another for collecting a new sample.

[0010] Such sampling instruments encounter a problem well known in the prior art: the risk of the tube being removed from the sampling body caused by the restoring force exerted on the tube by the sleeve. Indeed, the sleeve is generally made from an elastomer, for example rubber, and therefore has elastic properties. This problem - called "kickback" in the English-speaking literature - has been the subject of several publications.

[0011] A first solution consists of manufacturing a particular sampling body capable of compensating for the return force of the sleeve.

[0012] In this respect, European patent EP 0 342 653 B1 describes a sampling body which has, on its internal wall, an elastic bearing surface - or "land" in English - at the level of which the internal radius of the sampling body is reduced. Thus, when a tube is introduced into the sampling body, the bearing surface is deformed and then exerts a contact force on the tube making it possible to maintain it inside the sampling body.

[0013] Japanese patent application JP 2000245716 A also relates to a cylindrical sampling body, which comprises a retaining ring provided with elastic portions facing each other and inclined towards each other to reduce the internal radius of the sampling body. A spacer rod can be used to separate the elastic portions from each other and introduce a tube into the sampling body. Once the spacer rod is removed, the elastic portions move towards each other and then come into contact with the tube cap. The elastic portions thus act as stops, which makes it possible to retain the tube.

[0014] Such sampling bodies facilitate rapid replacement of one tube with another once sampling is complete. This first solution, however, has the disadvantage that it does not use standard sampling bodies available commercially, which involves material and financial costs.

[0015] To remedy this, a second solution proposes installing a holding member within a standard sampling body to prevent the tube from being removed.

[0016] In this respect, international application WO 2020 / 250859 A1 describes a body of holding member which comprises a hollow cylindrical body provided, on its external surface, with a circumferential ring and ribs for positioning in the sampling body. The holding member further comprises four arms which each extend from the cylindrical body towards the central axis of the holding member and each have a boss. Once the holding member is installed within the sampling body, a tube can be inserted into the cylindrical body and pushed down until it comes into contact with the respective bosses of the arms, which allow the tube to be held in position.

[0017] European patent EP 0 562 363 B1 relates to an adapter which also comprises a hollow cylindrical body, which is provided with a base which, when the adapter is installed within the sampling body, is in contact with the pair of collars of the sampling body. The adapter further comprises four arms which each extend from the cylindrical body towards the central axis of the adapter and all have, at their end, a gripping portion. Once the adapter is installed within the sampling body, a tube can be inserted into the cylindrical body and pushed down until it comes into contact with the respective gripping portions of the arms, which hold the tube in position.

[0018] Such holding members can be combined with standard sampling bodies and also facilitate the rapid replacement of one tube with another once sampling is complete. Furthermore, the friction, i.e. the resistance which arises from the contact between the holding member and the tube, is sufficient to hold the tube for the duration of sampling.

[0019] Still within the framework of a medical biology examination, the Applicant sought to use the sampling instruments according to the second solution as distribution instruments for the purposes of analyzing the sample of biological fluid taken. Indeed, during the analytical phase, the sample stored in the tube can be injected or aspirated into a biological analysis device such as a microfluidic cartridge.

[0020] However, the Applicant has found that these instruments do not offer the same reliability for the time of an analysis as for the time of a sample. In other words, the existing holding members to be installed within a standard sample body cannot be reused to distribute the sample taken, the risk of withdrawal of the tube - or "kickback" - then being too high.

[0021] The present invention improves the situation.

[0022] In this respect, the invention relates to an instrument for dispensing a sample of biological liquid comprising: - an elongated body having a cavity extending from a first end to a second end of the body, which body further has an opening at the first end and an orifice at the second end, - a needle partially covered with a sleeve and extending into the cavity from the second end, which needle opens onto the outside of the body via the orifice, - a tube closed by a stopper and housed at least partly in the cavity such that the stopper compresses the sleeve against the second end and the needle pierces the sleeve, pierces the stopper and penetrates the tube, and - a member arranged to prevent the tube from being withdrawn from the cavity by compensating for the restoring force exerted on the tube by the compressed sleeve.

[0023] The member includes a mounting portion by which the member is removably mounted to the body at the first end and an abutment portion by which the member blinds the opening.

[0024] In one or more embodiments, the body further has, at the first end, a first collar and a second collar to which the mounting portion is attached.

[0025] Typically, the body is a sample body.

[0026] In one or more embodiments, the mounting portion comprises a first lug and a second lug each defining a respective groove, and the member is rotatably mounted on the body at the first end to pivot between a locking position in which the first flange and the second flange are respectively received in the grooves of the first lug and the second lug and an unlocking position in which the first flange and the second flange are respectively released from the grooves of the first lug and the second lug.

[0027] Advantageously, the opening is substantially circular, and the mounting portion comprises a macaron sized to be received in the opening for the purpose of centering the member on the body.

[0028] In one or more embodiments, the member further has an extendable portion connecting the mounting portion to the abutment portion.

[0029] The extensible portion has, for example, a helical structure.

[0030] The tube may be sized such that it is only partially housed in the cavity, and the abutment portion is substantially in contact with the tube.

[0031] Alternatively, the tube may be sized such that it is fully housed within the cavity.

[0032] Such a tube is typically a pediatric tube.

[0033] In the case where the tube is entirely housed in the cavity, the stop portion may be substantially in contact with the tube.

[0034] However, as a variant, the dispensing instrument may further comprise an adapter having an elongated shape and within which the tube is received, which adapter is sized such that it is integral with the tube and projects from the body beyond the opening, and the stop portion is substantially in contact with the adapter.

[0035] In one or more embodiments, the dispensing instrument further comprises a connector for assembling the instrument with a biological analysis device, which connector extends outside the body from the second end and communicates with the needle through the port.

[0036] Advantageously, the connector is a male connector of the Simple Luer or Luer-Lock type.

[0037] Finally, the invention also relates to a kit of an instrument for dispensing a sample of biological liquid comprising: - an elongated body having a cavity extending from a first end to a second end of the body, which body further has an opening at the first end and an orifice at the second end, - a needle covered with a sleeve and arranged to be mounted on the body in such a way that it extends within the cavity from the second end and opens onto the outside of the body via the orifice, - a tube closed by a stopper and arranged to be introduced at least partly into the cavity via the opening such that the stopper compresses the sleeve against the second end and the needle pierces the sleeve, pierces the stopper and penetrates the tube, and - a member arranged to prevent the tube from being withdrawn from the cavity by compensating for the restoring force exerted on the tube by the compressed sleeve.

[0038] The member includes a mounting portion for being removably mounted on the body at the first end and a stop portion for blinding the opening.

[0039] Other characteristics, details and advantages will appear on reading the detailed description below, and on analyzing the attached drawings in which:

[0040] [Fig. 1] illustrates a kit of a dispensing instrument according to the invention;

[0041] [Fig.2] illustrates a sampling body;

[0042] [Fig.3] illustrates a Single Luer adapter;

[0043] [Fig.4] illustrates in perspective a member preventing the removal of the tube from the kit of the [Fig.l];

[0044] [Fig.5] illustrates in section the organ of [Fig.4];

[0045] [Fig.6] illustrates the dispensing instrument assembled from the kit of [Fig.l];

[0046] [Fig.7] illustrates the dispensing instrument in one embodiment in which a pediatric tube is used;

[0047] [Fig.8] illustrates the dispensing instrument in another embodiment in which, again, a pediatric tube is used; and

[0048] [Fig.9] illustrates the dispensing instrument of [Fig.6] installed on a device biological analyses.

[0049] [Fig.l] illustrates a kit 1 of a dispensing instrument, i.e. a set of spare parts to be assembled to form the dispensing instrument. As such, [Fig.l] can be seen as an exploded view of the dispensing instrument to be assembled.

[0050] In particular, the kit 1 comprises a sampling body 3, an adapter 5, a tube 7 - closed by a stopper 9 - and a member 11.

[0051] As illustrated in more detail in [Fig.2], the sampling body 3 is an elongated body 13 having a first end 15 and a second end 17 between which a cavity 19 extends.

[0052] The cavity 19 extends along the longitudinal direction - represented by an axis X - of the elongated body 13; the first end 15 and the second end 17 thus correspond to the ends of the elongated body 13 along this longitudinal direction X.

[0053] The cavity 19 is intended to house a tube - here the tube 7 - partially or completely. To this end, the elongated body 13 has, at the first end 15, an opening 21, which allows the tube 7 to be introduced into the cavity 19. In [Fig.2], the opening 21 is substantially circular.

[0054] The elongated body 13 also has, this time at the second end 17, an orifice 23, which makes it possible to assemble the sampling body 3 and an adapter - here the adapter 5. To do this, the orifice 23 can be tapped so as to be complementary to an external thread of the adapter 5. Of course, the sampling body 3 and the adapter 5 can be assembled differently, and the orifice 23 is therefore not necessarily tapped.

[0055] In the example of [Fig.2], the elongated body 13 further has a pair of collars - formed of a first collar 25 and a second collar 27 - at the first end 15.

[0056] Such a pair of collars is usually intended to facilitate the gripping of the sampling body 3. However, as explained in the remainder of the description, the Applicant had the idea of ​​taking advantage of the presence of this pair of collars to design a member - here the member 11 - preventing the tube from being withdrawn and capable of being attached to the pair of collars to be removably mounted on the elongated body 13 at the first end 15.

[0057] Typically, the first collar 25 and the second collar 27 extend from the opening 21 towards the outside of the cavity 19 in a plane orthogonal to the longitudinal direction X. Furthermore, the first collar 25 and the second collar 27 are arranged such that the longitudinal direction X is an axis of rotational symmetry of the sampling body 3.

[0058] The sampling body 3 is for example a BD Vacutainer sampling body (trademark registered by the company Becton, Dickinson and Company).

[0059] The adapter 5 is arranged to connect the dispensing instrument to a biological analysis device and to guide a sample of biological fluid contained in the tube 7 - for example blood, urine, cerebrospinal fluid, pleural fluid or synovial fluid - to the biological analysis device.

[0060] As illustrated in more detail in [Fig.3], the adapter 5 comprises an external thread 29, a needle 31 covered by a sleeve 33 and a connector 35.

[0061] The external thread 29 is complementary to the orifice 23 which, in the example described here, is tapped for the purpose of assembling the sampling body 3 and the adapter 5. Thus, once the needle 31 is inserted into the orifice 23, the adapter 5 can be screwed onto the elongated body 13 - for example manually by rotating the connector 35 - so as to secure the sampling body 3 and the adapter 5.

[0062] As mentioned previously, the assembly of the sampling body 3 and the adapter 5 can be carried out differently. Consequently, just as the orifice 23 may not be tapped, the adapter 5 may not have an external thread 29.

[0063] The needle 31 is intended to extend within the cavity 19 and, more particularly, to penetrate the tube 7 housed therein to come into contact with the sample of biological liquid to be analyzed. Typically, once the sampling body 3 and the adapter 5 are assembled, the needle 31 extends within the cavity 19 in the longitudinal direction X of the elongated body 13.

[0064] The sleeve 33 is arranged to isolate the needle 31 from the external environment, in particular during transport, storage or handling of the adapter 5, and this until the assembly of the dispensing instrument. In particular, the sleeve 33 fulfills a sealing function in that it prevents any contact of the needle 31 with a liquid or a gas. The sleeve 33 makes it possible to protect the needle 31 in order to avoid - or at least limit - any possible damage.

[0065] The sleeve 33 only ceases to cover the needle 31 during assembly of the dispensing instrument. Indeed, the stopper 9 - which closes the tube 7 - is caused to compress the sleeve 33 against the internal wall of the sampling body 3 at the second end 17 so that the needle 31 pierces the sleeve 33, pierces the stopper 9 and penetrates the tube 7.

[0066] The sleeve 33 is generally made from an elastomer such as rubber. The elastic properties of the sleeve 33 have the consequence that it, when compressed by the plug 9, exerts a restoring force on the tube 7, which is then likely to move in the longitudinal direction X or even to be expelled from the cavity 19. This problem of possible “kickback” is solved thanks to organ 11 described below.

[0067] The connector 35 is intended to extend outside the cavity 19 to allow the adapter 5 to connect to a biological analysis device. In particular, when the connector 35 is a male connector, it is intended to plug into a female connector of the biological analysis device. Typically, once the sampling body 3 and the adapter 5 are assembled, the connector 35 extends outside the cavity 19 in the longitudinal direction X of the elongated body 13.

[0068] The connector 35 communicates with the needle 31, which allows a sample of biological liquid present in the tube 7 to circulate to the biological analysis device via the needle 31 and then via the connector 35.

[0069] In the example of [Fig.3], the connector 35 is a male connector of the Single Luer type and, consequently, the adapter 5 is a Single Luer adapter.

[0070] The advantage of the male connector 35 of the Single Luer type is that biological analysis devices are often equipped with a female connector of the Single Luer type and that the connection obtained has a satisfactory seal.

[0071] Those skilled in the art will, however, understand that other connectors may be used. The Simple Luer type adapter 5 of [Fig. 3] may thus be replaced by another type of adapter comprising, for example, a Luer-Lock, quarter-turn or bayonet type connector. Of course, in such cases, the biological analysis device used is provided with an additional connector.

[0072] In particular, when the adapter 5 is a Luer-Lock type adapter, the latter is integrated into the sampling body 3. In other words, it is not necessary to screw the adapter 5 onto the elongated body 13: the sampling body 3 and the adapter 5 are a single piece. The adapter 5 therefore does not comprise an external thread 29, and the connector 35 - which is then a male Luer-Lock type connector - is already in the extension of the elongated body 13.

[0073] It may be noted that Luer-Lock type connectors are usually used to improve the assembly of syringes: the tip of the syringe barrel is thus provided with a male connector while the needle is provided with a female connector. The male and female connectors each have a conical shape, and more precisely a conicity of approximately 6%.

[0074] In the medical field, there are also intravascular and hypodermic applications for Luer-Lock type connectors. Such applications are governed in particular by the ISO 80369 standard.

[0075] Like the Simple Luer adapter, the Luer-Lock adapter has the advantage of being compatible with a large number of biological analysis devices, which are often equipped with a female Luer-Lock type connector within which a male Luer-Lock type connector can be received. Here again, the connection obtained is waterproof.

[0076] The member 11 is intended to compensate for the return force exerted on the tube 7 by the sleeve 33 compressed by the plug 9 against the second end 17 in order to prevent any withdrawal of the tube 7 from the cavity 19.

[0077] By “withdrawal” is meant here any movement of the tube 7 relative to the elongated body 13 likely to compromise or even prevent the operation of the dispensing instrument, for example by ending the contact between the needle 31 and the biological liquid to be analyzed present in the tube 7. Such a movement, which typically corresponds to a translation in the longitudinal direction X towards the outside of the cavity 19, can lead to the expulsion of the tube 7 from the sampling body 3.

[0078] To do this, the member 11 comprises, as illustrated in [Fig.4] and [Fig.5], a mounting portion 37 and a stop portion 39. More particularly, [Fig.4] and [Fig.5] are perspective and sectional views respectively of the member 11.

[0079] The mounting portion 37 allows the member 11 to be removably mounted on the sampling body 3 at the first end 15. More particularly, during assembly of the dispensing instrument, the member 11 is only mounted on the sampling body 3 after the tube 7 has been introduced into the cavity 19.

[0080] The stop portion 39 allows the member 11 to blind the opening 21 and is intended to provide mechanical resistance to the tube 7 to prevent the latter from being withdrawn from the cavity 19.

[0081] Furthermore, in the example of [Fig.4] and [Fig.5], the member 11 also comprises an extensible portion 41 connecting the mounting portion 37 to the stop portion 39. The member 11 also comprises an opening 43 for receiving the tube 7, in particular the bottom of the tube 7.

[0082] The extensible portion 41 gives the member 11 the general shape of a cylinder of revolution; the extensible portion 41 extends in the longitudinal direction - represented by an axis Y - of the member 11.

[0083] Once the member 11 is mounted on the sampling body 3 at the first end 15 by means of the mounting part 37, the Y axis substantially coincides with the X axis. The extensible portion 41 is then in the extension of the elongated body 13, and the opening 43 is opposite the opening 21. A part of the tube 7 - starting from the stopper 9 - is received in the sampling body 3 while the remaining part of the tube 7 - starting from the bottom of the tube 7 - is received in the member 11.

[0084] The extensible portion 41 allows the stop portion 39 to have flexible contact with the bottom of the tube 7 and to tolerate a slight displacement of the tube 7 along the longitudinal direction X (or Y). Indeed, a contact that is too rigid, offering strictly no margin of freedom to the tube 7, would risk damaging it in the event of an impact or excessive restoring force exerted by the sleeve 33 on the tube 7. The portion extensible 41 also allows the member 11 to adapt to tubes of different lengths. In the example described here, the extensible portion 41 has a helical structure.

[0085] As mentioned previously, the usual presence of a pair of collars - the first collar 25 and the second collar 27 - on the sampling body 3 gave the Applicant the idea of ​​a particular design of the member 11, and more precisely of a mounting portion 37 capable of being attached to the pair of collars.

[0086] According to this particular design, illustrated in detail in [Fig.4] and [Fig.5], the mounting portion 37 comprises a pair of ears - formed of a first ear 45 and a second ear 47 - each delimiting a respective groove. The first ear 45 thus delimits a first groove 49 while the second ear 47 delimits a second groove 51.

[0087] The first ear 45 and the second ear 47 can be seen as U-shaped protrusions projecting from the member 11 and extending generally in a direction orthogonal to the longitudinal direction Y. The member 11 is then similar to a symmetrical Guillemin half-coupling.

[0088] The mounting portion 37 described here makes it possible to achieve a quarter-turn type locking of the member 11 on the sampling body 3.

[0089] After the member 11 has been positioned on the sampling body 3 at the first end 15, it is then possible to pivot the member 11 until the first collar 25 and the second collar 27 are respectively received in the first groove 49 and the second groove 51. The member 11 is then in the locking position since it can no longer move in translation in the longitudinal direction X (or Y), and the stop portion 39, which is substantially in contact with the bottom of the tube 7, prevents the tube 7 from being removed from the cavity 19.

[0090] To remove the member 11, it is sufficient to pivot it so as to release the first collar 25 and the second collar 27 respectively from the first groove 49 and from the groove 51. The member 11 is then in the unlocked position since it can again move in translation in the longitudinal direction X (or Y) and be removed.

[0091] It should be noted that the mounting portion 37 may comprise means other than a pair of ears such as that described previously for mounting the member 11 on the sampling body 3.

[0092] A bayonet-type locking system may for example be used, in which case the mounting portion 37 has a pair of notches each fulfilling the function of a mortise while the first collar 25 and the second collar 27 each fulfill the function of a tenon. Once the member 11 is positioned on the sampling body 3 at the first end 15, it is then possible to press in the longitudinal direction X (or Y) on the member 11, for example at the level of the stop portion 39, to insert the first collar 25 and the second collar 27 into the corresponding notches and then to pivot the member 11 to put it in the locking position. To remove the member 11, it is sufficient to pivot it - the member 11 is then in the unlocking position -, then to pull it in the longitudinal direction X (or Y).

[0093] To facilitate the centering of the member 11 on the sampling body 3, the mounting portion 37 may comprise, as illustrated in [Fig.4] and [Fig.5], a macaron 53, that is to say a cylindrical-shaped pin whose diameter is large compared to its height.

[0094] The macaron 53 is sized to be received in the opening 21 - in the case where the latter is substantially circular, which is the case in [Fig.2] - and thus to be fitted into the elongated body 13. It should be noted that, in the example of [Fig.4] and [Fig.5], the macaron 53 delimits the opening 43 through which the tube 7 is received in the member 11.

[0095] [Fig.6] illustrates the dispensing instrument 55 obtained by assembling the parts of the kit 1 shown in [Fig.l], namely the sampling body 3, the adapter 5, the tube 7 - closed by the cap 9 - and the member 11.

[0096] The dispensing instrument 55 - which may also be referred to as a dispensing instrument - is arranged to deliver a sample of biological fluid to a biological analysis device. For example, the sample of biological fluid may be delivered by the dispensing instrument 55 by injection or by aspiration.

[0097] The dispensing instrument 55 is preferably assembled as follows: the adapter 5 is arranged on the elongated body 13 at the second end 17. To do this, the needle 31, covered with the sleeve 33, is inserted into the orifice 23. The adapter 5 - which is here similar to that of [Fig. 3] - is screwed using the external thread 29, which is complementary to the tapped orifice 23.

[0098] The tube 7, which contains a sample of biological fluid to be analyzed, is closed by the stopper 9. The tube 7 is then partially introduced into the cavity 19 of the elongated body 13 and is pushed therein such that the stopper 9 uncovers the needle 31 by progressively compressing the sleeve 33 against the second end 17. At the same time, the needle 31, after having pierced the sleeve 33, pierces the stopper 9 and penetrates the tube 7 to come into contact with the sample of biological fluid.

[0099] Finally, once the tube 7 is housed in the cavity 19, the member 11 is removably mounted on the elongated body 13 at the first end 15. The mounting portion 37 of the member 11 - which is here similar to that of [Fig.4] and [Fig.5] - comprises the first lug 45 and the second lug 47. A rotation, corresponding to a quarter turn, allows, on the one hand, the first groove 49 delimited by the first ear 45 to receive the first collar 25, and, on the other hand, to the second groove 51 delimited by the second ear 47 to receive the second collar 27. The member 11 is then in the locking position and the stop portion 39 is substantially in contact with the tube 7, and more precisely with the bottom of the tube 7.

[0100] The biological fluid sample can then circulate along the needle 31 to the connector 35. It should be noted that the adapter 5 may have a simpler structure than that described previously and, for example, not include a connector 35 so that the needle 31 opens directly onto the outside of the dispensing instrument 55 via the orifice 23.

[0101] The withdrawal of the tube 7 is, despite the restoring force exerted on the tube 7 by the sleeve 33, prevented by the member 11, and more precisely by the stop portion 39 which blinds the opening 21. Indeed, when the tube 7, pushed back by the sleeve 33, finds itself in contact with the stop portion 39, the latter compensates for the restoring force of the sleeve 33 by means of a possible margin of freedom in translation along the longitudinal direction X (or Y) left to the tube 7 by the extensible portion 4L

[0102] It is possible to assemble the dispensing instrument 55 in another way, for example by first assembling the elongated body 13 and the tube 7.

[0103] The tube 7, closed by the plug 9, is thus partially introduced into the cavity 19 of the elongated body 13 such that the plug 9 is opposite the orifice 23 at the level of the second end 17 and the bottom of the tube 7 is outside the cavity 19. The tube 7 thus protrudes from the cavity 19 through the opening 21.

[0104] The member 11 is then removably mounted on the elongated body 13 at the first end 15 as previously described.

[0105] Finally, the adapter 5 is screwed onto the elongated body 13 at the second end 17 by means of the external thread 29, which is complementary to the tapped orifice 23. The tube 7 being trapped by the elongated body 13 and the member 11, the needle 31 pierces the sleeve 33, pierces the stopper 9 and penetrates the tube 7 to come into contact with the sample of biological liquid. The sleeve 33, which uncovers the needle 31, is compressed against the second end 17 by the stopper 9.

[0106] The dispensing instrument 55 illustrated in [Fig. 6] is adapted to a tube 7 sized to contain a sample of biological fluid from an adult patient. Typically, such a collection tube has a length of between 70 and 80 millimeters (mm), and more generally equal to 75 millimeters (mm).

[0107] However, a medical biology examination can also be carried out in pediatrics, in which case the patient is a child - or even a toddler - and the volume of the biological fluid sample to be analyzed is significantly smaller than for an adult. During the pre-analytical phase, the sample is then taken with a small sampling tube: a pediatric tube. Typically, such a tube The sample length is between 41 and 51 millimeters (mm), and more generally equal to 46 millimeters (mm).

[0108] In view of [Fig. 6], it is understood that the dispensing instrument 55 as such does not make it possible to prevent the removal of a pediatric tube from the cavity 19, namely a movement of the pediatric tube relative to the elongated body 13 likely to compromise or even prevent the operation of the dispensing instrument 55. Indeed, due to its short length, the pediatric tube - and more precisely the bottom of the pediatric tube - is not in contact with the stop portion 39, which therefore cannot compensate for the return force exerted on the pediatric tube by the compressed sleeve 33.

[0109] [Fig.7] and [Fig.8] illustrate possible adaptations of the dispensing instrument 55 when using a pediatric tube. For the sake of simplification, the reference signs of [Fig.6] are reproduced identically in these figures; in particular, the tube - although corresponding to a pediatric tube - always bears the reference sign “7”.

[0110] First, [Fig.7] corresponds to an embodiment in which a pediatric tube 7 is used and is fully housed in the cavity 19 of the elongated body 13. To prevent any removal of the pediatric tube 7 from the cavity 19, an adapter 57 is used.

[0111] The adapter 57 has an elongated shape and has a cavity intended to receive the pediatric tube 7. In particular, the adapter 57 is sized so as to be integral with the pediatric tube 7 once the latter is received in the cavity.

[0112] In the example of [Fig. 7], the adapter 57 is similar to a sampling tube such as the tube 7 shown in [Fig. 6]. The dimensions of the cavity of the adapter 57, and in particular its radius, make it possible to wedge the pediatric tube 7 therein to make it integral with the adapter 57. In particular, the opening of the adapter 57 through which the pediatric tube 7 is received in the cavity has a radius which is only slightly greater than that of the opening of the pediatric tube 7. By "slightly greater" is meant here that the opening of the adapter 57 is large enough to accommodate the pediatric tube 7 but small enough for it to become wedged therein.

[0113] The adapter 57 also has a length allowing it to project from the elongated body 13 beyond the opening 21 to be substantially in contact with the stop portion 39. The member 11, by preventing any undesirable movement of the adapter 57, also prevents any removal of the pediatric tube 7 from the cavity 19 since the adapter 57 and the pediatric tube 7 are integral.

[0114] This embodiment has the advantage of requiring, as the only modification compared to the dispensing instrument 55 of [Fig.6], the presence of the adapter 57, which compensates for the insufficient length of the pediatric tube 7.

[0115] [Fig. 8] also corresponds to an embodiment in which a pediatric tube 7 is used and is therefore entirely housed in the cavity 19 of the elongated body 13. This time, to prevent any removal of the pediatric tube 7 from the cavity 19, the member 11 is configured such that, when it is removably mounted on the elongated body 13 at the first end 15, the stop portion 39 is substantially in contact with the pediatric tube 7, and more precisely with the bottom of the pediatric tube 7.

[0116] In the example of [Fig.8], the member 11 comprises a fold 59 which marks the folding of the stop portion 39 on the reverse side of the member 11 to allow the stop portion 39 to be substantially inside the elongated body 13 and, thus, to be in contact with the pediatric tube 7. The fold 59 defines a retracted portion 59 connecting the extensible portion 41 and the stop portion 39.

[0117] This embodiment therefore requires, rather than using the adapter 57, modifying the structure of the member 11.

[0118] [Fig.9] illustrates the dispensing instrument 55 of [Fig.6] installed on a biological analysis device 63 to deliver a sample of biological fluid to be analyzed.

[0119] The biological analysis device 63 is here a lab-on-a-chip (better known by the English acronym LOC for “lab-on-a-chip”). Labs-on-a-chip, the design of which is based on the miniaturization of components such as channels, valves and pumps, are generally used to carry out biological analyses on small volume samples and make it possible, among other things, to replace bulky devices, to implement a large number of analyses in parallel and to reduce the time required for experiments or tests.

[0120] More particularly, the biological analysis device 63 of [Fig.9] takes the form of a microfluidic cartridge - also called “microfluidic chip” in the English-speaking literature.

[0121] The microfluidic cartridge 63 comprises a fluidic card 65, a pneumatic card 67, a membrane 69 and a lower card 71.

[0122] The fluidic card 65 has a fluidic inlet 73 for the introduction - for example by injection or aspiration - of a sample of biological liquid to be analyzed and inlet / outlet orifices 75 for the introduction of reagents or the evacuation of waste. Furthermore, the fluidic card 65 comprises a network of microchannels provided with valves to allow the sample of biological liquid and the reagents to circulate as well as reaction chambers within which mixtures can be made.

[0123] The pneumatic card 67 is arranged to control the circulation of liquids within of the microfluidic cartridge 63, and more particularly to control the fluidic card 65. To do this, the pneumatic card 67 comprises pneumatic channels to actuate the opening and closing of the valves of the fluidic card 65 by targeted pressure variations.

[0124] The membrane 69 is intended to be interposed between the fluidic card 65 and the pneumatic card 67 so as to form a sandwich structure. The membrane 69 is elastic - or even hyperelastic - so that it can be deformed by the pressure induced by the pneumatic channels of the pneumatic card 67. Thus, any liquid present in the microfluidic cartridge 63 is caught between a fixed wall defined by the fluidic card 65 and a deformable wall defined by the membrane 69.

[0125] Finally, the lower card 71 is arranged to close the pneumatic channels of the pneumatic card 67 and thus offer external controls for controlling the fluidic card 65.

[0126] In the example of [Fig.9], the fluid inlet 73 is a female connector of the Single Luer type and is complementary to the connector 35 which is here a male connector of the Single Luer type. Of course, the fluid inlet 73 can be another type of connector; and, as specified above, the connector 35 is not necessarily a male connector of the Single Luer type. It is important above all that the connector 35 and the fluid inlet 73 have complementary shapes to ensure the connection of the dispensing instrument 55 and the microfluidic cartridge 63.

[0127] Once the dispensing instrument 55 is connected to the microfluidic cartridge 63, the biological liquid sample contained in the tube 7 can circulate to the microfluidic cartridge 63 via the needle 31 and the connector 35. It is then possible to carry out one or more analyses of the biological liquid sample with the microfluidic cartridge 63.

[0128] In the example of [Fig.9], the biological analysis device 63 to which the distribution instrument 55 is connected is a microfluidic cartridge. However, those skilled in the art understand that the distribution instrument 55 is compatible with any biological analysis device 63 having at least one inlet capable of receiving a sample of biological liquid to be analyzed.

Claims

Claims

1. An instrument (55) for dispensing a sample of biological fluid comprising: - an elongated body (13) having a cavity (19) extending from a first end (15) to a second end (17) of said body (13), which body (13) further has an opening (21) at the first end (15) and an orifice (23) at the second end (17), - a needle (31) partially covered by a sleeve (33) and extending within the cavity (19) from the second end (17), which needle (31) opens onto the outside of the body (13) via the orifice (23), - a tube (7) closed by a stopper (9) and housed at least partly in the cavity (19) such that the stopper (9) compresses the sleeve (33) against the second end (17) and the needle (31) pierces the sleeve (33), pierces the cap (9) and penetrates the tube (7),and - a member (11) arranged to prevent the tube (7) from being withdrawn from the cavity (19) by compensating for the return force exerted on the tube (7) by the compressed sleeve (33), said dispensing instrument (55) being characterized in that the member (11) comprises a mounting portion (37) by means of which the member (11) is removably mounted on the body (13) at the first end (15) and a stop portion (39) by means of which the member (11) blinds the opening (21).,

2. Dispensing instrument (55) according to claim 1, characterized in that the body (13) further has, at the first end (15), a first collar (25) and a second collar (27) to which the mounting portion (37) is attached.

3. Dispensing instrument (55) according to claim 2, characterized in that the body (13) is a sampling body.

4. A dispensing instrument (55) according to claim 2 or 3, characterized in that the mounting portion (37) comprises a first lug (45) and a second lug (47) each delimiting a respective groove (49, 51), and in that the member (11) is rotatably mounted on the body (13) at the first end (15) to pivot between a locking position in which the first collar (25) and the second collar (27) are respectively received in the grooves (49, 51) of the first lug (45) and the second lug (47) and an unlocking position in which the first collar (25) and the second collar (27) are respectively released from the grooves (49, 51) of the first lug (45) and the second lug (47).

5. A dispensing instrument (55) according to one of the preceding claims, characterized in that the opening (21) is substantially circular, and in that the mounting portion (37) comprises a macaron (53) sized to be received in the opening (21) for the purpose of centering the member (11) on the body (13).

6. Dispensing instrument (55) according to one of the preceding claims, characterized in that the member (11) further has an extensible portion (41) connecting the mounting portion (37) to the stop portion (39).

7. Dispensing instrument (55) according to claim 6, characterized in that the extensible portion (41) has a helical structure.

8. Dispensing instrument (55) according to one of the preceding claims, characterized in that the tube (7) is dimensioned such that it is only partially housed in the cavity (19), and in that the stop portion (39) is substantially in contact with the tube (7).

9. Dispensing instrument (55) according to one of claims 1 to 7, characterized in that the tube (7) is sized such that it is entirely housed in the cavity (19).

10. A dispensing instrument (55) according to claim 9, characterized in that the tube (7) is a pediatric tube.

11. Dispensing instrument (55) according to claim 9 or 10, characterized in that the stop portion (39) is substantially in contact with the tube (7).

12. Dispensing instrument (55) according to claim 9 or 10, characterized in that it further comprises an adapter (57) having an elongated shape and within which the tube (7) is received, which adapter (57) is dimensioned such that it is integral with the tube (7) and projects from the body (13) beyond the opening (21), and in that the stop portion (39) is substantially in contact with the adapter (57).

13. Dispensing instrument (55) according to one of the preceding claims, characterized in that it further comprises a connector (35) for assembling the instrument (55) with a biological analysis device (63), which connector (35) extends outside the body (13) from the second end (17) and communicates with the needle (31) through the orifice (23).

14. Dispensing instrument (55) according to claim 13, characterized in that the connector (35) is a male connector of the Simple Luer or Luer-Lock type.

15. Kit (1) of an instrument for dispensing (55) a sample of biological liquid comprising: - an elongated body (13) having a cavity (19) extending from a first end (15) to a second end (17) of said body (13), which body (13) further has an opening (21) at the first end (15) and an orifice (23) at the second end (17), - a needle (31) covered with a sleeve (33) and arranged to be mounted on the body (13) in such a way that it extends within the cavity (19) from the second end (17) and opens onto the outside of the body (13) via the orifice (23), - a tube (7) closed by a stopper (9) and arranged to be introduced at least partly into the cavity (19) via the opening (21) such that the stopper (9) compresses the sleeve (33) against the second end (17) and the needle (31) pierces the sleeve (33), pierces the stopper (9) and penetrates the tube (7), and - a member (11) arranged to prevent the withdrawal of the tube (7) from the cavity (19) by compensating for the return force exerted on the tube (7) by the compressed sleeve (33), said kit (1) being characterized in that the member (11) comprises a mounting portion (37) for being removably mounted on the body (13) at the first end (15) and a stop portion (39) for blinding the opening (21).

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