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 equipped with a device preventing tube withdrawal

[0001] The field of the invention relates to a dispensing instrument, in particular for the purpose 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 risk assessment of pathological conditions, as well as to the determination or monitoring of a patient's physiological or pathophysiological state.

[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 biological fluid sample from the patient, as well as the preparation, transport and storage of the sample; - an analytical phase, which corresponds to the technical process for obtaining 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 Luer Simple 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. At the first end, the sampling body has an opening for the insertion of a tube into the cavity, as well as a pair of collars for gripping the sampling body, and at the second end, a threaded hole for mounting the Luer Simple adapter onto the sampling body. The sampling body is, for example, a BD Vacutainer sampling body (a registered trademark of Becton, Dickinson and Company).

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

[0008] Finally, the tube, closed by a stopper, is inserted into the cavity via the opening of The stopper exerts pressure on the needle, which allows the needle to pierce the sleeve and the stopper to enter the tube. The tube is then pushed into the cavity until the stopper compresses the sleeve against the inner wall of the collection body at the other end.

[0009] The sampling instrument can be coupled, by means of the Luer Simple adapter, to a tube connected to a sampling needle, which allows a sample of biological fluid to be guided into the tube. Once filled, the tube can be removed from the sampling body and then replaced with another for the collection of a new sample.

[0010] Such sampling instruments encounter a problem well known in the prior art: the risk of the tube being withdrawn from the sampling body due to the kickback 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-language literature—has been the subject of several publications.

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

[0012] In this respect, European patent EP 0 342 653 B1 describes a sampling body which has, on its inner wall, an elastic bearing surface – or “land” – at which the internal radius of the sampling body is reduced. Thus, when a tube is inserted into the sampling body, the bearing surface is deformed and exerts a contact force on the tube, holding it inside the sampling body.

[0013] Japanese patent application JP 2000245716 A also relates to a cylindrical sampling body, which includes a retaining ring with opposing elastic portions inclined towards each other to reduce the internal radius of the sampling body. A spreader rod can be used to separate the elastic portions from each other and insert a tube into the sampling body. Once the spreader rod is removed, the elastic portions move closer together and come into contact with the tube's stopper. The elastic portions thus act as stops, which retains the tube.

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

[0015] To remedy this, a second solution proposes to install a retaining element within a standard sampling body to prevent the removal of the tube.

[0016] In this respect, international application WO 2020 / 250859 A1 describes an organ of The retaining device consists of a hollow cylindrical body with a circumferential ring and ribs on its outer surface for positioning within the sampling device. The retaining device further comprises four arms, each extending from the cylindrical body towards its central axis, and each featuring a raised boss. Once the retaining device is installed within the sampling device, a tube can be inserted into the cylindrical body and pushed down until it contacts the respective bosses on the arms, which then hold the tube in position.

[0017] European patent EP 0 562 363 B1 relates to an adapter that also comprises a hollow cylindrical body, which is provided with a base that, when the adapter is installed within the sampling body, is in contact with the pair of flanges of the sampling body. The adapter further comprises four arms, each extending from the cylindrical body towards the central axis of the adapter, and each having a gripping portion at its end. 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 retaining elements can be combined with standard sampling bodies and also facilitate the rapid replacement of one tube with another once the sampling is complete. Furthermore, the friction, i.e., the resistance arising from the contact between the retaining element and the tube, is sufficient to hold the tube in place during the sampling process.

[0019] Still within the context of a medical biology examination, the Applicant sought to use the sampling instruments according to the second solution as dispensing instruments for the purpose of analyzing the collected biological fluid sample. 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 duration of an analysis as for the duration of a sample collection. In other words, the existing retaining elements installed within a standard collection body cannot be reused to dispense the collected sample, as the risk of tube withdrawal—or “kickback”—is then 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 fluid comprising: - an elongated body having a cavity extending from one 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 by a sheath and extending into the cavity from the second end, which needle opens to the outside of the body via the orifice, - a tube closed by a stopper and housed at least partially in the cavity such that the stopper compresses the sleeve against the second end and the needle pierces the sleeve, passes through the stopper and enters the tube, and - a device 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 organ includes a mounting portion by means of which the organ is removably mounted on the body at the first end and a stop portion by means of which the organ 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 sampling body.

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

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

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

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

[0030] The tube can be dimensioned so that it is only partially housed in the cavity, and the stop portion is substantially in contact with the tube.

[0031] Alternatively, the tube can be sized so that it is entirely housed in 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 can be substantially in contact with the tube.

[0034] However, alternatively, the dispensing instrument may further comprise an adapter having an elongated shape and within which the tube is received, which The adapter is dimensioned so that it is integral with the tube and protrudes from the body by extending beyond the opening, and the stop portion is substantially in contact with the adapter.

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

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

[0037] Finally, the invention also relates to a kit for a biological fluid sample dispensing instrument comprising: - an elongated body having a cavity extending from one 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 into the cavity from the second end and emerges outside the body via the orifice, - a tube closed by a stopper and arranged to be inserted at least partially into the cavity via the opening such that the stopper compresses the sleeve against the second end and the needle pierces the sleeve, passes through the stopper and enters the tube, and - a device 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 component 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 features, details and advantages will become apparent upon reading the detailed description below, and upon analysis of the accompanying drawings on 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 Simple Luer adapter;

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

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

[0045] [Fig.6] illustrates the dispensing instrument assembled from the kit of [Fig.1];

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

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

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

[0049] Fig. 1 illustrates a kit 1 of a distribution instrument, that is to say, a set of spare parts to be assembled to form the distribution instrument. As such, Fig. 1 can be seen as an exploded view of the distribution instrument to be assembled.

[0050] In particular, kit 1 includes a sampling body 3, an adapter 5, a tube 7 - closed by a cap 9 - and an organ 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 extends a cavity 19.

[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 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 inserted 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 allows the sampling body 3 and an adapter - here the adapter 5 - to be assembled. 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 presents a pair of collars - formed of a first collar 25 and a second collar 27 - at the level of the first end 15.

[0056] Such a pair of collars is usually intended to facilitate the grasping of the sampling body 3. However, as explained in the rest of the description, the Applicant had the idea of ​​taking advantage of the presence of this pair of collars to design an organ - here organ 11 - preventing the removal of the tube and able to hook onto the pair of collars to be mounted removably 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 outwards from 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 symmetry by rotation of the sampling body 3.

[0058] The sampling body 3 is for example a BD Vacutainer sampling body (trademark registered by 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 includes an external thread 29, a needle 31 covered with a sleeve 33 and a fitting 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 turning the fitting 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. Therefore, just as the orifice 23 may not be tapped, the adapter 5 may not have an external thread 29.

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

[0064] The sleeve 33 is arranged to isolate the needle 31 from the external environment, particularly during transport, storage, or handling of the adapter 5, up until the dispensing instrument is assembled. In particular, the sleeve 33 performs a sealing function by preventing any contact of the needle 31 with a liquid or gas. The sleeve 33 protects the needle 31 to prevent—or at least limit—any potential damage.

[0065] The sleeve 33 only ceases to cover the needle 31 during the assembly of the dispensing instrument. Indeed, the cap 9 – which closes the tube 7 – is caused to compress the sleeve 33 against the inner wall of the sampling body 3 at the second end 17 in such a way that the needle 31 pierces the sleeve 33, passes through the cap 9 and enters the tube 7.

[0066] The sleeve 33 is generally made from an elastomer such as rubber. The elastic properties of the sleeve 33 mean that when compressed by the plug 9, it exerts a restoring force on the tube 7, which is then liable to move along the longitudinal direction X or even be expelled from the cavity 19. This potential "kickback" problem is resolved by organ 11 described below.

[0067] The connector 35 is designed 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 designed to fit 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 along the longitudinal direction X of the elongated body 13.

[0068] The fitting 35 communicates with the needle 31, which allows a sample of biological fluid present in the tube 7 to circulate to the biological analysis device by passing through the needle 31 and then through the fitting 35.

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

[0070] The male 35 fitting of the Luer Simple type has the advantage that biological analysis devices are often equipped with a female Luer Simple type fitting and that the resulting connection provides a satisfactory seal.

[0071] However, those skilled in the art understand that other connectors can be used. The Luer-type adapter 5 of [Fig. 3] can thus be replaced by another type of adapter including, for example, a Luer-lock, quarter-turn, or bayonet connector. Of course, in such cases, the biological analysis device used is equipped with a complementary connector.

[0072] In particular, when the adapter 5 is a Luer-Lock type adapter, it 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 unit. The adapter 5 therefore does not include an external thread 29, and the fitting 35 – which is then a male Luer-Lock type fitting – is already an extension of the elongated body 13.

[0073] It may be noted that Luer-Lock type fittings are commonly used to improve syringe assembly: the syringe barrel tip is thus fitted with a male fitting while the needle is fitted with a female fitting. Both the male and female fittings have a conical shape, more precisely a taper of approximately 6%.

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

[0075] Like the Luer Simple 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 connector into which a male Luer-Lock connector can be received. Here again, the resulting connection is waterproof.

[0076] The member 11 is intended to compensate for the restoring 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 displacement of the tube 7 relative to the elongated body 13 which is 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 fluid to be analyzed present in the tube 7. Such a displacement, which typically corresponds to a translation along the longitudinal direction X outwards from the cavity 19, can lead to the expulsion of the tube 7 from the sampling body 3.

[0078] To this end, 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 cross-sectional views of the member 11, respectively.

[0079] The mounting portion 37 allows the organ 11 to be removably mounted on the sampling body 3 at the first end 15. More particularly, during the assembly of the distribution instrument, the organ 11 is mounted on the sampling body 3 only 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 oppose mechanical resistance to the tube 7 to prevent its withdrawal from the cavity 19.

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

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

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

[0084] The extendable 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, excessively rigid contact, offering absolutely no freedom to the tube 7, could damage it in the event of an impact or excessive restoring force exerted by the sleeve 33 on the tube 7. The portion The extensible portion 41 also allows the component 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 organ 11, and more specifically of a mounting portion 37 suitable for attaching 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 lugs—formed of a first lug 45 and a second lug 47—each defining a respective groove. The first lug 45 thus defines a first groove 49, while the second lug 47 defines a second groove 51.

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

[0088] The mounting portion 37 described here allows for a quarter-turn locking of the organ 11 onto 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 rotate the member 11 until the first flange 25 and the second flange 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 along 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 removal of the tube 7 from the cavity 19.

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

[0091] It should be noted that the mounting portion 37 may include means other than a pair of ears such as that described previously for mounting the organ 11 onto the harvesting 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 acting as a mortise, while the first collar 25 and the second collar 27 each act as a tenon. Once the organ 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 member 11, for example at the stop portion 39, insert the first collar 25 and the second collar 27 into the corresponding notches, then rotate member 11 to the locking position. To remove member 11, simply rotate it – member 11 is then in the unlocked position – and then pull it out in the longitudinal direction X (or Y).

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

[0094] The macaron 53 is dimensioned to be received in the opening 21 - in the case where this 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 organ 11.

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

[0096] The dispensing instrument 55 – which can also be referred to as a dispensing instrument – ​​is arranged to deliver a sample of biological fluid to a biological analysis device. By way of example, the biological fluid sample can 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 positioned on the elongated body 13 at the second end 17. To do this, the needle 31, covered by the sleeve 33, is inserted into the orifice 23. The adapter 5 - which is here similar to that of [Fig.3] - is screwed in 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 inserted into the cavity 19 of the elongated body 13 and pushed in so that the stopper 9 exposes the needle 31 by progressively compressing the sleeve 33 against the second end 17. At the same time, the needle 31, after piercing the sleeve 33, pierces the stopper 9 and enters 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 organ 11 is removably mounted on the elongated body 13 at the first end 15. The mounting portion 37 of the organ 11—which is similar here to that of [Fig. 4] and [Fig. 5]—includes the first ear 45 and the second ear 47. A rotation, corresponding to a quarter turn, allows, on the one hand, the first groove 49 delimited by the The first ear 45 receives the first collar 25, and, on the other hand, the second groove 51 delimited by the second ear 47 receives the second collar 27. The organ 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 flow along the needle 31 to the fitting 35. It should be noted that the adapter 5 may have a simpler structure than that described previously and, for example, not include a fitting 35 so that the needle 31 opens directly onto the outside of the dispensing instrument 55 via the orifice 23.

[0101] Despite the restoring force exerted on the tube 7 by the sleeve 33, the withdrawal of the tube 7 is prevented by the member 11, and more precisely by the stop portion 39 which blocks the opening 21. Indeed, when the tube 7, pushed back by the sleeve 33, comes into 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 extendable portion 4L

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

[0103] The tube 7, closed by the stopper 9, is thus partially inserted into the cavity 19 of the elongated body 13 such that the stopper 9 is opposite the orifice 23 at the level of the second end 17 and that 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 organ 11 is then removably mounted on the elongated body 13 at the first end 15 as described previously.

[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. With the tube 7 held captive by the elongated body 13 and the component 11, the needle 31 pierces the sleeve 33, passes through the stopper 9, and enters the tube 7 to make contact with the biological fluid sample. The sleeve 33, which exposes the needle 31, is then 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 biological fluid sample from an adult patient. Typically, such a collection tube has a length between 70 and 80 millimeters (mm), and more generally equal to 75 millimeters (mm).

[0107] However, a medical biology examination can also be performed 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 collected using a smaller collection tube: a pediatric tube. Typically, such a tube the sampling 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 prevent the withdrawal of a pediatric tube from the cavity 19, namely a displacement of the pediatric tube relative to the elongated body 13 which is 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 restoring force exerted on the pediatric tube by the compressed sleeve 33.

[0109] Figures 7 and 8 illustrate possible adaptations of the dispensing instrument 55 when using a pediatric tube. For the sake of simplicity, the reference symbols from Figure 6 are used identically in these figures; in particular, the tube – although corresponding to a pediatric tube – still bears the reference symbol “7”.

[0110] First, [Fig.7] corresponds to an embodiment in which a pediatric tube 7 is used and is entirely 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 for receiving the pediatric tube 7. In particular, the adapter 57 is dimensioned so as to be integral with the pediatric tube 7 once it 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 in the adapter 57, and in particular its radius, allow the pediatric tube 7 to be wedged into it, making it secure to the adapter 57. In particular, the opening in the adapter 57 through which the pediatric tube 7 is received into the cavity has a radius that is only slightly larger than that of the opening in the pediatric tube 7. By "slightly larger," it is meant here that the opening in the adapter 57 is large enough to accommodate the pediatric tube 7 but small enough for it to become wedged in place.

[0113] The adapter 57 also has a length which allows it to protrude from the elongated body 13 by extending beyond the opening 21 to be substantially in contact with the stop portion 39. The organ 11, by preventing any undesirable movement of the adapter 57, also prevents any withdrawal of the pediatric tube 7 from the cavity 19 since the adapter 57 and the pediatric tube 7 are joined.

[0114] This embodiment has the advantage of requiring, as the only modification compared to the distribution 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 withdrawal of the pediatric tube 7 from the cavity 19, the organ 11 is configured so 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 organ 11 includes a fold 59 which marks the folding of the stop portion 39 on the reverse of the organ 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 adapter 57, modifying the structure of organ 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 (LOC). Labs-on-a-chips, whose design is based on the miniaturization of components such as channels, valves and pumps, are generally used to perform biological analyses on small-volume samples and allow, among other things, the replacement of bulky devices, the implementation of a large number of analyses in parallel and the reduction of the time required for experiments or tests.

[0120] More specifically, the biological analysis device 63 of [Fig.9] takes the form of a microfluidic cartridge - also called "microfluidic chip" in the English-language 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 biological fluid sample to be analyzed, and inlet / outlet ports 75 for the introduction of reagents or the removal of waste. Furthermore, the fluidic card 65 includes a network of microchannels equipped with valves to allow the biological fluid sample and reagents to circulate, as well as reaction chambers within which mixing can be carried out.

[0123] The pneumatic card 67 is arranged to control the flow of liquids within of the microfluidic cartridge 63, and more specifically to control the fluidic card 65. To do this, the pneumatic card 67 includes 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 trapped 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 provide external controls to operate the fluidic card 65.

[0126] In the example of [Fig. 9], the fluid inlet 73 is a female Luer fitting and is complementary to the fitting 35, which is a male Luer fitting. Of course, the fluid inlet 73 can be of another type of fitting; and, as mentioned above, the fitting 35 is not necessarily a male Luer fitting. It is essential that the fitting 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 fluid sample contained in the tube 7 can flow to the microfluidic cartridge 63 via the needle 31 and the fitting 35. It is then possible to carry out one or more analyses of the biological fluid sample with the microfluidic cartridge 63.

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

Claims

Demands

1. A biological fluid sample dispensing instrument (55) comprising: - an elongated body (13) having a cavity (19) extending from a first end (15) to a second end (17) of said body (13), said body (13) further having 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), said needle (31) opening onto the exterior of the body (13) via the orifice (23), - a tube (7) closed by a stopper (9) and housed at least partially within 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 stopper (9) and enters the tube (7),and - a member (11) arranged to prevent the withdrawal of the tube (7) from the cavity (19) by compensating for the restoring 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) blocks 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. 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 defining a respective groove (49, 51), and in that the member (11) is rotationally mounted on the body (13) at the first end (15) to pivot between a locking position in which the first flange (25) and the second flange (27) are respectively received in the grooves (49, 51) of the first ear (45) and the second ear (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 ear (45) and the second ear (47).

5. Dispensing instrument (55) according to any one of the preceding claims, characterized in that the opening (21) is substantially circular, and in that the mounting portion (37) includes a button (53) dimensioned 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 any one of the preceding claims, characterized in that the member (11) further has an extendable 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 any one of the preceding claims, characterized in that the tube (7) is dimensioned so 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 any one of claims 1 to 7, characterized in that the tube (7) is dimensioned so that it is entirely housed in the cavity (19).

10. 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 so that it is integral with the tube (7) and protrudes from the body (13) by exceeding the opening (21), and in that the stop portion (39) is substantially in contact with the adapter (57).

13. A dispensing instrument (55) according to any one of the preceding claims, characterized in that it further comprises a fitting (35) for assembling the instrument (55) with a biological analysis device (63), which fitting (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 fitting (35) is a male fitting of the Luer Simple or Luer-Lock type.

15. Kit (1) of a biological fluid sample dispensing instrument (55) 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 partially 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 enters the tube (7), and - a component (11) arranged to prevent the withdrawal of the tube (7) from the cavity (19) by compensating for the restoring 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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