Kit for the sampling of biological liquid such as urine and method utilizing such kit

Abstract

The invention relates to a kit (1) for the sampling of biological liquid in particular urine comprising: a flexible accumulator (2) of biological liquid adapted to collect the liquid comprising at least one liquid absorbing layer (10) and at least one support layer (11) attached thereto; at least one closed recipient (3) comprising a tubular container (5) with a tubular sidewall portion (6) and a bottom portion (7) forming an elongated tubular cavity (9) and a closing lid (5) sealingly connected to the sidewall portion (6); wherein the accumulator (2) is configured for being inserted in the tubular cavity (9) of the container, wherein the recipient (3) comprises holding means (12) configured for maintaining the accumulator in position in the recipient and distant from the bottom portion (7) of the container.

Claims

1. A kit for the sampling of a biological liquid comprising: a flexible accumulator of the biological liquid adapted to collect the liquid from a human body formed as an elongated band comprising at least one liquid absorbing layer and at least one support layer attached thereto; at least one closed recipient comprising a tubular container with a tubular sidewall portion and a bottom portion forming an elongated tubular cavity and a closing lid sealingly connected to an open end of the sidewall portion opposite the bottom portion; wherein the accumulator is configured for being inserted in the tubular cavity of the container through the open end when the closing lid is removed; and wherein the recipient further comprises holding means configured for maintaining the accumulator in position in the recipient and a distance from the bottom portion of the container upon re-closing of the container to enable liquid previously absorbed by the accumulator to be collected in the recipient in a reserved volume part not occupied by the accumulator between the bottom portion of the recipient and the accumulator when the recipient centrifuged in a centrifugal liquid collecting machine.

2. The kit according to claim 1, wherein a length of the absorbing layer of the accumulator is shorter than an internal depth of the tubular cavity.

3. The kit according to claim 1, wherein the holding means are configured to define the reserved volume part not occupied by the accumulator when held in the recipient; said reserve volume part being sized between about 1 and 10 ml.

4. The kit according to claim 1, wherein the holding means comprises an abutment member located in the reserved volume part of the cavity and sized to hold the accumulator above the bottom portion of the container.

5. The kit according to claim 4, wherein the holding means comprises a series of ribs provided at an internal surface of the tubular sidewall portion.

6. The kit according to claim 5, wherein the ribs are oriented along an axial direction of the elongated tubular cavity and end by free edges in a direction toward the open end of the container and wherein adjacent ones of the ribs are distanced one another by a linear distance of less than 2 cm, and adapted to hold the accumulator at least when the accumulator is partially rolled in the recipient about a longitudinal axis.

7. The kit according to claim 4, wherein the abutment member is a removable elongated insert of smaller length than an internal depth of the cavity and comprising a transversal cross-section selected from one of a cross, a full tube, a partial tube, and a grid.

8. The kit according to claim 1, wherein the holding means comprises an elongated rigid support platform comprising a holding surface configured for receiving the accumulator and attachment means configured for being attached to an internal side of the lid, wherein the support platform has a length shorter than an internal depth of the tubular cavity, and wherein the holding means is fixed to the lid, the holding means is the distance from the bottom portion of the recipient when the lid is closed.

9. The kit according to claim 8, wherein the support platform is a rectangular plate-like member larger than a width of the accumulator and smaller than a width of the tubular sidewall portion.

10. The kit according to claim 8, wherein the support platform comprises at least one retaining member configured for holding the accumulator at least in an axial direction of the container, wherein the support layer is retained in contact with the support platform.

11. The kit according to claim 10, wherein the retaining member comprises one or more of: a slider on the platform, an attachment pin, a mechanical adhesive and a chemical adhesive.

12. The kit according to claim 1, further comprising a diaper, the diaper comprising, at an external side, a collecting area comprising, a hole or liquid permeable wall area, wherein accumulator is removably fixed to the collecting area by means of an attachment layer larger in area than a surface of the support layer of the accumulator, wherein the attachment layer protects the accumulator in the collecting area during collection of the biological liquid, and wherein the attachment layer comprises a reversible, pressure sensitive adhesive inner surface arranged for holding, in a removable manner, the accumulator in the collecting area.

13. A method for collecting the biological liquid using the kit according to claim 1, comprising the steps of: charging the absorbing layer of the accumulator with the liquid; inserting the accumulator in the container while the accumulator is being held by the holding means, wherein the accumulator is held at the distance from the bottom portion of the container; closing the recipient by the lid; centrifuging the recipient in the liquid centrifugal machine to collect the liquid in the reserved volume part of the elongated cavity of the container, wherein the holding means holds the accumulator in place, and wherein the reserved volume part of the cavity is unoccupied by the accumulator when collecting liquid in the reserve volume part.

14. The method according to claim 13, wherein a volume of the reserved volume part of the cavity is about 1 to 5 ml.

15. The method according to claim 13, wherein the recipient is closed by the closing lid with the interior cavity being sterile before opening by removal of the closing lid.

16. The kit according to claim 1, wherein the holding means are configured to define the reserved volume part not occupied by the accumulator when held in the recipient; said reserve volume part being sized between about 0.5 and 2.5 cm long.

17. The method according to claim 1, wherein the biological liquid is urine.

Description

BRIEF DESCRIPTION OF THE FIGURES BRÈVE DESCRIPTION DES FIGURES

[0045] Features described in relation to one aspect may equally be applied to other aspects of the invention.

[0046] Embodiments of the invention will now be described, by way of preferred examples only, with reference to the accompanying drawings, in which:

[0047] FIG. 1 shows a first embodiment of the kit of the invention;

[0048] FIG. 2 shows the recipient of the kit of FIG. 1;

[0049] FIG. 3 is a longitudinal cross-section view of the accumulator of the kit of the invention;

[0050] FIG. 4 is a transversal cross-sectional view of the container of the recipient of the kit according to the embodiment of FIG. 1;

[0051] FIG. 5 illustrates the assembling of the kit of FIG. 1 for liquid sampling purpose;

[0052] FIG. 6 is a schematic representation of the centrifugation of the kit for collecting biological liquid in the container of the kit;

[0053] FIG. 7 shows a second embodiment of the kit of the invention;

[0054] FIG. 8 shows the accumulator retained on the support platform of the kit of FIG. 7;

[0055] FIG. 9 is a cross-section view of the container of the kit according to a first variant of the mode of FIG. 1;

[0056] FIG. 10 is a cross-section view of the container of the kit according to a second variant of the mode of FIG. 1;

[0057] FIG. 11 is a cross-section view of the container of the kit according to a third variant of the mode of FIG. 1;

[0058] FIG. 12 is a schematic representation of a diaper and accumulator of the kit of the invention for collecting the urine from a human body;

[0059] FIG. 13 is a plane view of the diaper and accumulator of FIG. 12.

DETAILED DESCRIPTION OF THE DRAWINGS

[0060] A first mode of the sampling kit 1 of the invention is illustrated in FIGS. 1 to 6. The kit comprises a flexible accumulator 2 for collecting biological liquid, in particular urine, on a human body and a closed recipient 3 adapted for receiving the flexible accumulator and for sampling liquid collected by the accumulator in a centrifugation medical device.

[0061] The recipient 3 comprises an elongated tubular container 4 and a closing lid 5. In the closed configuration before first use, the interior surfaces of the recipient are preferably sterile. The process of sterilization can occur during the manufacturing of the container such as by gamma irradiation or other suitable techniques. The closing lid 5 is connected to the container in removable and repeatable manner such as by a threading assembly. The connection is preferably a sealing connection in the sense that the interior environment can be maintained sterile during an extensive period of storage.

[0062] In a possible mode, the container can be closed in sterile fashion before its first opening by means of a closing lid formed by at least one peelable sealing membrane. A combination of a threaded lid associated to or on top of a peelable sealing membrane is also a possible closing lid.

[0063] As shown in FIG. 2, the tubular container 4 comprises an elongated tubular sidewall portion 6, a bottom portion 7 at a first end of the tubular portion and an open end 8. The tubular container is preferably cylindrical. However, other forms are possible. The elongated tubular sidewall portion and bottom portion define an elongated internal cavity 9 extending along a longitudinal axis I.

[0064] An example of liquid accumulator 2 is represented on FIG. 3. It comprises at least one absorbing layer 10 and a support layer 11; both are made of flexible materials so that the accumulator can be conformed to fit to a diaper for collecting urine. In particular, the liquid absorbing layer is designed to absorb a sufficient quantity of liquid, more preferably between 1 and 5 ml. The liquid absorbing layer is preferably made of hydrophilic material an/or that can store liquid. The layer can be formed of fibres such as a nonwoven or a fabric. A suitable material can be a combination of viscose and polystyrol. The thickness t1 can be of 1 to 3 mm, its length L1 may be between 3 and 8 cm and its width w1 can be of 1 to 3 cm.

[0065] The support layer 11 is designed to avoid the absorbing layer to tear apart. It can be a tear resistant film made of polymer and/or cellulose or paper. Its dimensions (L, w) are preferably higher than the dimensions (L1, w1) of the absorbing layer 10. In particular, its length L can be of 5 to 12 cm and its width w can be of 1.5 to 4 cm.

[0066] According to an aspect of the invention, the tubular recipient 3 comprises holding means designed for holding the accumulator 2 when it is inserted in the container, such holding means being such that it avoids the accumulator from collapsing during centrifugation. In this mode, the holding means comprises a series of holding ribs 12, 12a, 12b, 12c, 12d oriented in the longitudinal direction I and protruding on the internal surface of the sidewall portion 6. The ribs comprise free edges 13; at least some of them being located at distance M from the bottom portion 7 such that a reserved volume part 14 of the cavity is provided between the bottom portion and an upper cavity portion 15 without ribs. The diameter d of the sidewall portion of the container and the distance M are thus defined to create a volume, which is commensurate with the amount of liquid contained in the accumulator and/or the amount of liquid required for subsequent analysis. The diameter d of the container is preferably smaller than the width w of the accumulator, preferably 1.5 to 3 times smaller, such that the accumulator needs to be rolled about its longitudinal axis to be properly inserted in the container open as illustrated in FIG. 5. As a result, by virtue of its axially rolled configuration, the accumulator becomes more rigid than if inserted flat or unrolled. Moreover, due to the natural tendency of the accumulator to return to its unrolled position, the accumulator applies to the periphery of the tubular portion and so abuts on the series of holding ribs 12 in such rolled configuration. It is also to be noted that the length N of the upper volume of the cavity of the container which is not occupied by the holding means is preferably dimensioned to be shorter than the length L1 of the absorbing layer 10 so that the absorbing layer can be inserted in the container fully and without being folded in axial direction of the recipient. The length L of the accumulator is also preferably smaller than the length N of the upper volume but it can also be slightly longer and e.g. can be folded at the open end 8 and e.g. can be pinched between the container and the closing lid (as schematically illustrated in FIG. 6).

[0067] The number of ribs can be variable, preferably between 2 and 10. They are preferably distributed over the circumference of the internal surface of the sidewall portion. They may end before the bottom portion or may extend down to the bottom portion. The neighbouring ribs may be distanced from a small distance such as 3 to 5 mm; whereas the difference between the internal diameter of the container d and the longest distance between ribs d1 (i.e. “d-d1”) is designed to provide sufficient support to the accumulator. For example, the radial thickness of each rib is between 0.8 and 2 mm. Preferably, the container and ribs are formed as a single integral piece of polymer such as by blow moulding, extrusion or injection.

[0068] Other shapes of the holding means are represented as possible examples in FIGS. 9, 10 and 11. The holding means may be at least one insert 16, 17, 18 which is separable from the container and dimensioned to fit in the cavity while leaving a reserved part 14 for liquid to settle.

[0069] For example, in FIG. 9, the insert 16 forms a hollow profile with a loop-shaped holding wall 19 and a central aperture 20. The hollow profile may have many various cross-section shapes such as cross-like shape (as represented) or cylindrical or polygonal shapes.

[0070] In FIG. 10, the holding means comprises an insert 17 formed of two moon-like shaped parts 21, 22 connected by a central link 23. The parts can form together a single integral piece or alternatively separate pieces.

[0071] In FIG. 11, the holding means comprises an aperture grid. The grid can separate the reserved part of cavity for the liquid from the accumulator placed above in the rest of the cavity of the container.

[0072] Once closed or re-closed by the threaded lid with the accumulator fitted in, the recipient can be centrifuged in a conventional medical centrifugal machine for separating the liquid from the accumulator. The centrifugal speed can be controlled between 200 and 800 rpm between e.g. 20 seconds and 5 minutes, to force liquid 25 to settle in the reserved part of the volume beside the bottom portion. The volume of sampled liquid may vary from 1 to 5 ml depending on the capacity of the accumulator and the capacity of the reserved part 14.

[0073] A second embodiment is illustrated in relation to FIGS. 7 and 8. In this case, the accumulator 2 is held by a support platform 26 allowing the accumulator to be inserted flat inside the recipient. Thus, the support platform 26 comprises a support surface 27 for receiving the support layer 11 of the accumulator. The width W of the platform is chosen slightly wider than the width w of the accumulator and lateral guiding ridges 28, 29, 30, 31 may be provided at the side and/or corners of the platform to facilitate positioning and contact of the accumulator on the support surface 27. Preferably, a retaining member 32 such as a slider may be provided at the distal axial end of the support platform to prevent the accumulator to move axially towards the bottom portion of the container during centrifugation. The slider may be formed as a L-shaped element with a transversal stopping wall 33, a top stopping wall 34 and with one or two opposite transversal openings 35 for enabling a first end 36 of the support layer of the accumulator to be inserted in. Preferably, a second slider 37 is provided at the proximal end 38 of the support platform for grabbing the second end 39 of the support layer. As a result, the accumulator is axially stopped and retained on the platform. Moreover, due to the small differential transversal dimensions, [i=d (minus) W] between the internal diameter of the container and the width of the platform, preferably smaller than 0.5 cm, the accumulator is not allowed to move transversally to such an extent that it can disengage from the retaining members 32, 37.

[0074] The support platform can be attached to the recipient, either to the container or lid, by any suitable means, provided the support platform is maintained at distance from the bottom portion 7 of the tubular container such as to provide the reserve part 14 of volume for liquid. For example, the support platform comprises a connection member 40, e.g. a pin, at its proximal end which engages a complementary connection member 41, e.g. a hose provided at the interior side of the lid 5. The pin and hose may be assembled e.g. by force fitting or screwing or any other suitable assembly means resisting centrifugation.

[0075] The kit 1 of the invention may encompass a collecting diaper 42 as illustrated in FIG. 12; the diaper comprising a collecting area 43 opens towards the external side 44 of the diaper. The collecting area 43 may be a e.g. rectangular, hole through the thickness of the diaper or a locally liquid permeable wall of the diaper enabling liquid, in particular urine to pass from the inside of the diaper through the collecting area and to the absorbing layer of the accumulator as shown by arrow in FIG. 12. For example, a permeable wall can be formed of a thin tissue and/or porous fibres. The accumulator 2 is designed and dimensioned (L, w) to externally cover the collecting area (of dimensions L0, w0) of the diaper, as illustrated in FIG. 13. The accumulator can be maintained in place on the diaper during the collection time by an attachment layer 45 of even larger dimensions, (L3, w3) than the dimensions of the accumulator (L, w). The dimension of the absorbing layer (L1, w1) (not represented) is preferably slightly larger than the dimensions (L0, w0) of the collecting area to prevent leakage of liquid out between the accumulator and the diaper. The attachment layer 45 preferably comprise a reversible pressure sensitive mechanical and/or chemical adhesive which at least makes the attachment layer adhere to the external surface of the diaper, and preferably also to the support layer 11 of the accumulator. A mechanical adhesive may be e.g. a respectively buckle surface or anchoring surface connecting to a respectively anchoring surface or buckle surface of the diaper and/or accumulator, known as for instance, a Velcro-type connection means. A reversible chemical adhesive may be any adhesive such as methylcellulose and the like.

[0076] The invention further relates to a method for sampling a biological liquid, in particular urine, by means of the kit as described generally or in any of the preceding preferred modes.

[0077] The method comprises the following steps: [0078] collecting the biological liquid in the accumulator 2 by associating the accumulator with a collecting diaper 42, [0079] providing the closed recipient 3 preferably internally sterile, opening it and inserting the accumulator 2 charged with biological liquid in the recipient and closing it; while the accumulator being held by the holding means 12, 16, 17, 18, 26 in the container to define a reserved volume part 14 of the recipient between the bottom portion 7 of the container and the accumulator 2 fitted in the container; [0080] transferring liquid from the accumulator 2 to the reserved volume part 14 of the recipient, preferably by centrifugation of the recipient, [0081] optionally, storing the recipient 3 closed for subsequent analysis of the reserved liquid 25.