EP4031867A1

EP4031867A1 - Device for taking a sample of biological liquid

Info

Publication number: EP4031867A1
Application number: EP20771859.4A
Authority: EP
Inventors: Guillaume JULIEN; Morgane LEBLANC; Bernard BOUISSOU; Didier FABBRO; Julien CALVE; Philippe LUMBIERRES; Cyril CAUCHOIS; Jean-Christophe Cau
Original assignee: Iki
Current assignee: IKI
Priority date: 2019-09-17
Filing date: 2020-09-16
Publication date: 2022-07-27
Anticipated expiration: 2040-09-16
Also published as: WO2021052984A1; US20220280934A1; JP2022548097A; EP4031867C0; EP4031867B8; FR3100889A1; EP4031867B1; FR3100889B1

Abstract

The invention relates to a device (12, 112, 212) for taking a biological liquid sample intended to be able to be inserted into a portable reader (14) able to analyse the biological liquid, the device (12, 112, 212) comprising a strip (30, 130, 230) comprising, on its upper face, a plurality of colour-changing reactive elements (32, 132, 232) arranged one after the other; an absorbent assembly (28, 128, 228) comprising a deposition portion (37, 137, 237) on which to deposit the biological liquid; a band (38, 138, 238) for the diffusion of the biological liquid arranged over the top of the plurality of reactive elements (32, 132, 232); a housing (16, 116, 216) comprising a housing bottom (24, 124, 224), the strip (30, 130, 230) being arranged in the bottom of the housing (24, 124, 224), the lower face of the strip (30, 130, 230) being arranged facing the housing bottom (24, 124, 224), each reactive element (32, 132, 232) being arranged by transparency through the strip (30, 130, 230) facing an opening (52, 152, 252) in the housing bottom (24, 124, 224); a cover (26, 126, 226) arranged over the top of the diffusion band (38, 138, 238) and comprising at least one protruding pattern (60, 172, 288) forming a pressing surface configured to press the diffusion band (38, 138, 238) into contact with the plurality of reactive elements (32, 132, 232); an access opening (56, 156, 256) configured to provide access to the deposition portion (37, 137, 237).

Description

Title of the invention: Device for taking a biological liquid sample

Technical field of the invention

The present invention relates to a device for taking a biological fluid sample. It applies, in particular, to a urine sample collection cartridge for urine marker value analysis.

Prior art

[0002] It is common for healthcare professionals to be able to have a sample of biological fluid such as urine or saliva analyzed. It is known to use strips equipped with a few reactive elements, the color of which may vary on contact with the biological fluid. After soaking the strip in the body fluid, the reagents may change color. A first known way of reading colors and its interpretation is to detect the change in color with the naked eye and to interpret this change according to a color correspondence table at a concentration of compound in the biological fluid. Another way is to use a cumbersome and expensive apparatus for the analysis of the strip comprising the reactive elements at a health professional.

It has already been attempted to solve this problem by offering the general public to dip himself strips equipped with reactive elements in a jar comprising for example urine, and to analyze himself at the naked eye, change the color of the reagents and interpret the colors according to a leaflet supplied with the strip.

This home solution does not always reliably inform the user, the user may have difficulty discerning a change in color with regard to the instructions, the time of soaking of the strip in the biologist liquid n ' not necessarily being controlled by the user, the time latency between the end of soaking and the interpretation of the colors of the reagents is also not always controlled by the user.

Presentation of the invention

[0005] The present invention aims to remedy these drawbacks with a completely innovative approach.

To this end, according to a first aspect, the present invention relates to. a biological liquid sample collection device intended to be able to be inserted into a portable biological fluid analysis reader, the collection device comprising a transparent or translucent strip extending along a longitudinal axis and comprising on its upper face a plurality reactive color change elements arranged one after the other along the longitudinal axis; an absorbent assembly extending along the longitudinal axis and comprising a portion for depositing biological fluid; a biological fluid diffusion band arranged over the plurality of reactive elements; a casing extending along the longitudinal axis between two lateral ends, the casing comprising: a casing bottom, the strip being arranged at the bottom of the casing, the lower face of the strip being arranged opposite the casing bottom, each element reagent being arranged transparently through the strip facing an opening in the case back; a top cover arranged over the diffusion strip, and comprising at least one protruding pattern forming a first bearing surface configured to press the diffusion strip into contact with the plurality of reactive elements; an access opening configured to access the biological fluid deposition portion

The invention is implemented according to the embodiments and variants set out below, which are to be considered individually or in any technically operative combination.

Advantageously, the biological liquid deposit portion can be arranged through the access opening. The absorbent assembly may be a single blotting paper.

Advantageously, the portion for depositing biological liquid may include an absorbent reservoir strip distinct from the diffusion strip; The box which may include a second bearing surface configured to press at least a contact portion of the absorbent strip reservoir) in contact with a contact pad of the diffusion strip.

Advantageously, the reservoir absorbent strip and the diffusion strip can be arranged generally longitudinally one after the other, the reservoir strip can be configured to be movable in translation along the longitudinal axis; the contact portion may be arranged at the end of the reservoir absorbent strip; the contact portion being configurable to strike the second bearing surface by pushing along the longitudinal axis of the reservoir absorbent strip so as to be brought into contact with the contact pad of the diffusion strip.

Advantageously, the diffusion strip and the reservoir absorbent strip may respectively comprise a diffusion blotting paper and a reservoir blotting paper distinct from the diffusion blotting paper, the reservoir blotting paper comprising a liquid absorption characteristic greater than that of the diffusion blotting paper.

Advantageously, the diffusion band may comprise a plurality of reception areas arranged successively along the longitudinal axis, each reactive element being arranged under a single reception area, the diffusion band possibly comprising a recess of material between each of the reception areas.

Advantageously, the access opening can be arranged on one of the lateral ends of the housing. The housing may have two opposing longitudinal walls internal to the housing forming a slide cooperating with a removable support of the absorbent assembly, the removable support being configured to be inserted into the housing through the access opening.

[0014] Alternatively, the access opening can be arranged on the housing cover or on the housing bottom.

Brief description of the figures

Other advantages, aims and characteristics of the present invention emerge from the following description given, for explanatory and in no way limiting, with reference to the accompanying drawings, in which: [0016] [Fig. 1] Figure 1 is a schematic perspective view of a biological liquid sample analysis system comprising a biological liquid sample collection device according to a first embodiment of the invention, and an analysis reader of the sample of the biological fluid taken by the device.

[0017] [Fig. 2] FIG. 2 is a schematic exploded perspective view from above of the device for collecting a biological liquid sample according to the first embodiment of the invention.

[0018] [Fig. 3] FIG. 3 is a schematic exploded perspective view from below of the device for collecting a biological liquid sample according to the first embodiment of the invention.

[0019] [Fig. 4] Figure 4 is a schematic perspective view from above of a biological liquid sample collection device according to a second embodiment of the invention and according to a first positioning of the biological liquid deposition portion.

[0020] [Fig. 5] FIG. 5 is a schematic exploded perspective view of the device of FIG. 4.

[0021] [Fig. 6] FIG. 6 is a schematic exploded perspective view from below of the device of FIG. 4.

[0022] [Fig. 7] FIG. 7 is a schematic perspective view from above by transparency of the device of FIG. 4.

[0023] [Fig. 8] FIG. 8 is a schematic view in longitudinal section of the device of FIG. 4.

[0024] [Fig. 9] Figure 9 is a schematic perspective view from above of the biological fluid sample collection device according to the second embodiment of the invention and according to a second positioning of the biological fluid deposition portion.

[0025] [Fig. 10] FIG. 10 is a schematic perspective view from above by transparency of the device of FIG. 9.

[0026] [Fig. 11] FIG. 11 is a schematic view in longitudinal section of the device of FIG. 9. [0027] [Fig. 12] FIG. 12 is a schematic perspective view from above of a device for collecting a biological liquid sample according to a third embodiment of the invention.

[0028] [Fig. 13] FIG. 13 is a schematic perspective view from above of a collection device of FIG. 12 in which the portion for depositing biological fluid is extracted from the housing of the device.

[0029] [Fig. 14] FIG. 14 is a schematic exploded perspective view from above of the sampling device of FIG. 13.

[0030] [Fig. 15] FIG. 15 is a schematic exploded perspective view from above of the case back and of a strip comprising the reactive elements of FIG. 14.

[0031] [Fig. 16] FIG. 16 is a schematic view in longitudinal section of the device of FIG. 12.

[0032] [Fig. 17] Figure 17 is an enlargement of a portion of Figure 16.

[0033] [Fig. 18] FIG. 18 is a schematic perspective view from above of a device for collecting a biological liquid sample according to a fourth embodiment of the invention.

[0034] [Fig. 19] FIG. 19 is a schematic perspective view from above of a collection device of FIG. 18 in which the portion for depositing biological fluid is extracted from the housing of the device.

[0035] [Fig. 20] FIG. 20 is a schematic exploded perspective view from above of the sampling device of FIG. 19.

[0036] [Fig. 21] FIG. 21 is a schematic perspective view of a biological liquid sample analysis system according to the fourth embodiment comprising a reader for analyzing the sample of the biological fluid and the sample collection device biological fluid not inserted in the analysis reader.

[0037] [Fig. 22] Figure 22 is a schematic perspective view of the system of Figure 21 in which the body fluid sample collection device is first pushed into the body fluid sample analysis reader.

[0038] [Fig. 23] Figure 23 is a schematic perspective view of the system of Figure 21 in which the liquid sample collection device biologic is inserted with a second push into the body fluid sample analysis reader.

Description of the embodiments

[0039] According to FIG. 1, a system 10 for analyzing a biological fluid sample comprises a device 12, or cartridge, for collecting a biological fluid sample and a portable reader 14 for analyzing a biological fluid sample. For the purposes of positioning the elements with one another, and in a non-limiting manner with regard to the overall orientation of the sampling device 12 and of the reader 14, left and right orientations are defined along a longitudinal axis L and orientations above and below, or upper and lower, are defined along a vertical axis V. The device 12 for taking a biological liquid sample is intended to be inserted into the portable reader 14 for analyzing biological liquid. The sampling device 12 comprises a housing 16 extending generally along the longitudinal axis L between two left and right lateral ends 18, 20, the housing 16 being configured to be inserted in translation, in a longitudinal direction D, in an opening 22 of the reader 14. By way of non-limiting example, it has been defined that a sampling device 12 of approximately 10 centimeters in length along the longitudinal axis L, of a thickness less than one centimeter along the vertical axis V and of a width along an axis transverse to the longitudinal axis L of the order of a centimeter could correspond to the need.

According to Figure 2 and Figure 3, and according to a first embodiment, the sampling device 12 of Figure 1 comprises the housing 16 comprising a lower element or housing base 24 and an upper element or cover 26 allowing to close the top of the housing 16. The sampling device 12 comprises an absorbent assembly 28, extending along the longitudinal axis L, configured to be arranged in the housing 16. The sampling device 12 also comprises a strip 30 s' extending longitudinally and comprising on its upper face a plurality of reactive elements 32, 34 with color change arranged one after the other along the longitudinal axis L. In the context of the invention, it should be understood by change of color color, the evolution of the color of a reactive element 32, 34 when it is brought into contact with a biological liquid, for example and without limitation, a change from orange to blue for an indication of acidity (or also denoted 'pH') of the biological fluid, but also from an appearance of color, that is to say from the white appearance of the reactive element 32, 34 to a pink coloration upon detection of nitrites in the biological fluid in contact with the suitable reactive element 32, 34. By way of non-limiting example, and according to the dimensions of the sampling device 12 indicated above, a strip 30 which may include ten reagent elements 32, 34 is compatible with the housing 16 and is suitable for a sufficiently exhaustive analysis of biological fluid.

The absorbent assembly 28, such as an absorbent paper capable of absorbing a liquid, has the role of receiving the biological liquid and of diffusing it in contact with the reactive elements 32, 34. For this purpose, according to this first method of embodiment, the absorbent assembly 28 comprises a reservoir absorbent strip 36 provided for the deposition of biological liquid, and a diffusion strip 38 configured to diffuse by capillary action the biological liquid previously deposited on the reservoir absorbent strip 36 on the reactive elements 32, 34 of the strip 30. The absorbent reservoir strip 36 therefore comprises at least one portion configured to be in contact with the diffusion strip 38.

For this purpose, preferably, the diffusion strip 38 and the absorbent reservoir strip 36 respectively comprise a diffusion blotting paper and a reservoir blotting paper separate from the diffusion blotting paper, the reservoir blotting paper comprising an absorption characteristic of liquid greater than that of the diffusion blotting paper. The reservoir blotting paper should allow absorption of a quantity of biological fluid necessary for the analysis, and also allow rapid transfer of the biological fluid to the diffusion blotting paper. By way of non-limiting example, it was found that a reservoir blotting paper with a thickness between 2 and 3 millimeters, and with a liquid absorption characteristic of between 200 and 300 milligrams of liquid per square centimeter could be suitable for sampling device 12, this type of reservoir blotting paper comprising a liquid advance speed of between 3 and 5 cm for a time of ten seconds. It has also been found that a diffusion blotting paper comprising a thickness less than one millimeter, preferably between 0.2 and 0.6 millimeter, and an absorption capacity of between 20 and 40 milligrams of liquid per square centimeter could be suitable for the device 12 sampling, this type of diffusion blotting paper comprising a liquid advance speed of between 0.5 and 1.5 cm for a time of 10 seconds.

According to the first embodiment of Figure 2 and Figure 3, the reservoir absorbent strip 36 and the diffusion strip 38 are arranged generally longitudinally one after the other. The absorbent reservoir strip 36 extending from the right side end 20 of the housing 16 to its second end forming a contact portion 40, the diffusion strip 38 extending from the left side end 18 of the housing 16 as far as 'at its second end forming a contact pad 42. The contact portion 40 is configured to be in contact with the diffusion strip 38. The contact portion 40 is arranged over the contact pad 42 of the end of the screen. the broadcast band 38.

The strip 30 is arranged below the diffusion strip 38. More particularly, the upper face of the strip 30, equipped with the plurality of reactive elements 32, 34 faces the lower face of the diffusion strip 38 so that the diffusion band 38 can come to rest on the reactive elements 32, 34, allowing a reaction of the reactive elements 32, 34 in contact with the biological liquid diffused by capillary action through the diffusion band 38.

According to the first embodiment shown in Figure 2 and in Figure 3, the diffusion of biological fluid through the diffusion band takes place from the contact portion 40 of the reservoir absorbent band 36 in contact with the contact pad 42 from the end of the diffusion strip 38, to the end opposite to the contact pad 40 of the diffusion strip 38. For this purpose, when the reactive elements 32, 34 are in contact of the diffusion band 38, they are in turn in contact with the biological liquid diffusing in the longitudinal direction D. In particular, and in order to avoid pollution phenomena, or contamination, between reactive elements 32, 34 successive, the diffusion strip 38 comprises a plurality of reception areas 44, 46 arranged successively along the longitudinal axis L and separated from each other along the longitudinal axis L by a material recess 48, 50 of the strip diffusion 38. Each reactive element 32 is configured to be arranged in contact with a single reception area 44, the diffusion strip 38 comprising a material recess between each of the reception areas 44, 46.

Preferably and as shown in Figure 2 and Figure 3, the reception areas 44, 46 are arranged along a longitudinal edge of the diffusion band 38, thus forming a series of areas of reception 44, 46 in the form of successive slots.

This embodiment allows the biological liquid to diffuse along the other longitudinal edge of the diffusion band 38, this other edge being opposite to the edge forming the crenellations. To this end, the biological liquid can impregnate the reception areas 44, 46 successively and gradually one after the other.

According to Figure 2 and Figure 3, the strip 30 is configured to be arranged in the housing bottom 24 along the longitudinal axis L. The lower face of the strip 30, that is to say the face of the strip 30 opposite to the face of strip 30 on which the reactive elements 32, 34 are arranged, is arranged facing the case bottom 24. In order to be able to read the color change of the reactive elements 32, 34 arranged on the upper face of the strip 30, the strip 30 is preferably a transparent strip 30, each reactive element 32, 34 of the strip being arranged, by transparency through the strip 30, facing a opening 52 of the case back 24.

According to the first embodiment of Figure 2 and Figure 3, the opening 52 of the housing bottom 24 is an opening 52 extending longitudinally, of a length along the longitudinal axis L slightly less than that of the strip 30 and of a width, in a direction transverse to the longitudinal axis L, slightly less than that of the strip 30, so that the strip 30 can bear on the periphery of the opening 52 of the case back 24. In order to be able to keep the strip 30 fixed against lateral movements, the strip 30 is configured to be arranged between a first side wall 51 of a first edge of the housing bottom 24 extending longitudinally, and stop pins 53 side of the strip 30 arranged on the housing bottom 24. In order to be able to keep the strip 30 fixed against translational movements along the longitudinal axis L, the strip 30 is configured to be arranged between a transverse wall 55 of the left end of the case back 24 and another transverse wall 57, opposite to the transverse wall 55 of the left end of the case back 24, arranged on the case back 24. It should be noted that the strip 30 makes it possible in particular to keep the reactive elements 32, 34 fixed in the housing 16, and protect the reactive elements 32, 34 from impurities outside the housing 16

According to Figure 2 and Figure 3, the case back 24 is configured to be able to maintain fixed the diffusion band 38 both against longitudinal movements against lateral movements. To this end, the lateral stop pins 53 of the strip 30 are configured to be arranged between slots or recesses of material 48, 50 of the diffusion strip 38. The edge of the diffusion strip 38 not comprising any crenellations is configured to be arranged in abutment against a second side wall 59 of the second edge of the housing bottom 24 extending longitudinally.

According to Figure 2 and Figure 3, the reservoir absorbent strip 36 is of generally parallelepipedal shape. The housing bottom 24 has a plurality of transverse support tabs 64 extending between each longitudinal edge of the housing bottom 24 and projecting inwardly of the housing 16. The transverse support tabs 64 of the plurality of transverse tabs 64 of support are regularly spaced from the right side end 20 of the housing bottom 24 so as to be able to maintain the reservoir absorbent strip 36 in a balanced manner when closing the housing 16.

According to Figure 2 and Figure 3, the cover 26 of the housing 16 comprises a housing 54 configured to receive the absorbent strip reservoir 36. The housing 54 is formed by a reduction of material from the inner face of the cover 26. The housing 54 extends longitudinally from the end right side 20 of the cover 26 and is generally of rectangular shape making it possible to keep fixed both against the translational movements along the longitudinal axis L, as against the lateral movements, the reservoir absorbent strip 36. The housing 54 of the reservoir absorbent strip 36 comprises an access opening 56 allowing direct access to a portion of the reservoir absorbent strip 36 from the outside of the housing 16 of the sampling device 12. The portion of the reservoir absorbent strip 36 arranged opposite the access opening 56 forms a portion 37 for depositing the biological liquid.

According to Figure 2 and Figure 3, the internal face of the cover 26 comprises tabs 60 of supports projecting on the internal face of the cover 26, the tabs 60 of supports extending longitudinally from the lateral end left 18 of the cover 26 up to the housing 54 of the absorbent reservoir strip 36. The support tabs 60 form protruding patterns towards the inside of the housing 16, the tabs 60 being configured to rest on the diffusion strip 38 In addition to the support tabs 60, the internal face of the cover 26 comprises support pads 62 configured to rest against reception areas 44, 46 of the diffusion strip 38.

According to the first embodiment of Figure 2 and Figure 3, when the housing 16 is closed, that is to say when the periphery of the cover 26 is fixed with the periphery of the housing bottom 24, for example without limitation, by clipping, the absorbent reservoir strip 36 is in contact with the diffusion strip 38, the diffusion strip 38 is in contact with the reactive elements 32, 34. More particularly, when the housing 16 is closed, the internal surface of the housing 54 resting on the reservoir absorbent strip 36. The reservoir absorbent strip 36 is therefore compressed between the internal surface of the housing 54 and the transverse tabs 64 so that the contact portion 40 of the reservoir absorbent strip 36 is located in contact resting against contact pad 42 of the diffusion strip 38. To this end, in the event of deposit of biological liquid on the deposit portion 37 of the sampling device 12, the biological liquid can diffuse from the absorbent strip tank 36 up to the diffusion band 38. When the housing 16 is closed, the tongues 60 of longitudinal supports exert pressure on the diffusion strip 38 towards the bottom of the housing 24. In addition, when the housing 16 is closed, the support pads 62 exert a bearing force on the diffusion band 38, allowing contact in bearing of the reception areas 44, 46 against the reactive elements 32, 34. The bearing force exerted by the longitudinal bearing tabs 60 associated with the support force exerted by the support pads 62 on the diffusion strip 38, allows a reliable and durable support contact of the reception areas 44, 46 against the reactive elements 32, 34, thus allowing, in the event of presence of biological liquid on the diffusion band 38, a reliable reaction of the reactive elements 32, 34 with the biological liquid which can result in a change of color of the reactive elements 32, 34.

According to the first embodiment of the sampling device 12 of Figure 2 and Figure 3, it is advantageous that the strip 30, preferably transparent, can be flexible in order to withstand the constraints of assembly of the device 12 debit. For this purpose, it is advantageous that the strip 30 is a strip 30 of plastic material. Other material solutions, such as, for example, and without limitation, glass or poly methyl methacrylate, could have been envisaged. For the purpose of automatically reading the color change of the reactive elements 32, 34, that is to say, for example and without limitation, by reading assisted by an optical reading type technology, the strip 30 may not must be transparent, but only allow the passage of light, like a translucent material. Alternatively to the first embodiment, the access opening 56 could also have been arranged on the case back 24. Also, it could have been possible to provide a first access opening on the case back 24 and a second. access opening on the cover 26.

According to Figure 4, Figure 5 and Figure 6, a second embodiment of a sampling device 112 is shown. This second embodiment differs from the first embodiment in that the reservoir absorbent strip 136 is no longer arranged in a housing of the cover 126 which is fixed against movements in translation. Absorbent element 128 includes a reservoir absorbent strip 136 arranged through a side access opening 156 arranged on the right side face of the right side end 120 of the housing 116 so that the portion 137 for depositing the biological liquid of the reservoir absorbent strip 136 is configured to be arranged on the outside of the housing 116. The deposit portion 137 is advantageously configured to be covered by a cap 166 making it possible to manipulate the sampling device 112 manually without having to grip the device 112 directly by touching the portion. 137 deposit during its insertion into the reader 14. According to this second embodiment, the reservoir absorbent strip 136 is arranged so as to be able to be movable in translation along the longitudinal axis L.

More particularly and according to Figure 5 and Figure 6, the reservoir absorbent strip 136 comprises from its left end to its right end, successively, a contact portion 140 configured to be in contact with the strip of diffusion 138, a guide portion 168 in translation configured to be arranged in a guide ring 170, and the portion 137 for depositing biological liquid. The reservoir absorbent strip 136 and the diffusion strip 138 are arranged generally longitudinally one after the other in a generally similar manner to the first embodiment.

The guide ring 170 is arranged integral with the guide portion 168 of the reservoir absorbent strip 136. The guide ring 170 cooperates with guide rails extending inside the housing 116 from the opening d side access 156. The guide ring 170 is configured to extend simultaneously inside the housing 116 so as to be partially arranged on its guide rails and also partially outside the housing 116 so as to form a first stop stop for the cap 166 when the latter is arranged in translation on the deposit portion 137.

More particularly, the guide ring 170 comprises an upper element and a lower element respectively comprising a male element such as a tenon and a female element, the guide portion 168 in translation of the absorbent strip tank 136 comprising a fixing opening 171 allowing the passage of the female element of the lower element through the reservoir absorbent strip 136 in order to allow the coupling of the two elements of the guide ring 170. The guide ring 170 is configured to hold the portion of guide 168 during a translation of the reservoir absorbent strip 136.

The cover 126 of the housing comprises a support section 127 arranged above the reception areas 144, 146 of the broadcast band 138 and configured to bear on the reception areas 144, 146 of the band diffusion 138 when the housing 116 is closed to bring the receiving areas 144, 146 into contact with the reactive elements 132, 134. The cover 126 of the housing comprises a sliding section 129 arranged raised opposite the section d 'support 127 and configured for the translational sliding of the guide ring 170, the guide rails being arranged in this sliding section 129. The cover 126 comprises a sloping transition section 131 connecting the support section 127 and the section slide 129. The contact pad 142 of the end of the diffusion strip 138 is arranged at least partially below the transition section of the cover 126.

According to Figure 7 and Figure 8, the contact portion 140 of the reservoir absorbent strip 136 is configured to be arranged out of contact with the contact pad 142 of the diffusion strip 138 according to an initial position of the ring 170 guide. According to this initial position, the guide ring 170 forms a first stopper for the cap 166 when it is arranged in translation on the deposit portion 137.

According to Figure 9, Figure 10 and Figure 11, the guide ring 170 is configured to be slid in translation inwardly of the sliding section 129 by pushing action P on the cap 166 to that the cap 166 abuts on the outer periphery of the side access opening 156 of the housing 116, the periphery of the side access opening 156 forming a second stopper for the cap 166. During translation of the guide ring 170, along the longitudinal axis L, towards the inside of the sliding section 129, the contact portion 140 of the absorbent reservoir strip 136 strikes the internal surface of the section transition 131 of the cover 126 so as to be bent towards the contact pad 142 of the diffusion strip 138. In other words, the inner surface of the transition section 131 is a bearing surface of the cover 126 for the contact portion 140 la of the reservoir absorbent strip 136. When the cap 166 is in abutment on the periphery of the lateral access opening 156, according to FIG. 10 and FIG. 11, the contact portion 140 of the absorbent strip reservoir 136 is folded against the internal surface of the transition section 131 until it comes to bear in contact with the contact pad 142 of the diffusion strip 138.

[0064] Optionally, the sliding section 129 can comprise a locking means of the stop notch type of the guide ring 170, the immobilizing means being configured to immobilize the guide ring 170 when it is depressed by the cap 166 in the stop position against the second stopper. The immobilization means can advantageously only be operational until a certain extraction force is exerted on the cap 166 or directly on the deposit portion 137. By way of non-limiting example, the immobilizing means may include at least one boss on a guide rail so that the guide ring 170 must be inserted with adequate force to override this boss. This boss can generate a tactile rendering of confirmation of effective insertion of the reservoir absorbent strip 136 in the sampling device 112 so as to ensure that the contact portion 140 of the reservoir absorbent strip 136 is brought into contact with the pad. contact 142 of the diffusion band 138.

According to Figure 5 and Figure 6, the second embodiment also differs from the first embodiment in that the case back 124 has a plurality of openings 152, 153 of the case back arranged one to the other. series of others along the longitudinal axis L. In order to be able to read the change in color of the reactive elements 132, 134 arranged on the upper face of the strip 130, each reactive element 132, 134 of the strip 130 is arranged , by transparency through the strip 130, facing a single opening 152 of the case back 124 different from another opening 154 of the case back 124 associated with another element reagent 134. Although in accordance with the first embodiment, a single longitudinally extending case back opening 124 could be suitable, the solution consisting of a plurality of case back openings 152, 154 makes it possible to strengthen the overall structure. of the case back 124.

According to Figure 4 and Figure 5, the second embodiment also differs from the first embodiment in that the upper surface of the cover 126 has a first boss 172 and a second boss 174, each boss 172, 174 forming projection outwardly of the housing 116. Advantageously, the first boss 172 is arranged in the vicinity of the free end of the bearing section 127 of the cover 126 so as to be vertically aligned with the left end of the diffusion strip 138, the second boss 174 being arranged straddling between the transition section 131 of the cover 126 and the bearing section 127 of the cover 126. The first boss 172 and the second boss 174 make it possible to guarantee a plane maintenance along the longitudinal axis L of the diffusion strip 138 as it is inserted into the portable biological fluid sample analysis reader 14, the first boss 172 and the second boss 174 being inserted in friction with a wall of the lect. eur 14 so as to exert pressure on the diffusion band 138. The first boss 172 and the second boss 174 also help to strengthen the contact between the reception areas 144, 146 of the diffusion band 138 on the reactive elements 132, 134. It will be appropriate that along the length along the longitudinal axis L of the diffusion strip 138, a single boss or a plurality of bosses distributed over the upper surface of the cover 126 may also be suitable according to the invention. Overall, the first boss 172 and the second boss 174 make it possible to press the sampling device 112 on the base of the reader at the end of its travel, the approach being done with play.

According to Figure 12, Figure 13 and Figure 14, a third embodiment of a sampling device 212 is shown. This third embodiment differs in particular from the first embodiment in that the housing 216 comprises a lateral access opening 256 arranged on the right side face of the right end 220 of the housing 216, similarly to the second embodiment. . The sampling device 212 comprises a handle 266 for manipulating the sampling device 212 configured to be arranged in abutment against the periphery of the lateral access opening 256.

According to Figure 13 and Figure 14, the third embodiment differs from the second embodiment in that the handling handle 266 allows the insertion and complete extraction of the absorbent assembly 228 of the housing 216. In addition, particularly in the third embodiment, the sampling device 212 includes a removable support 276 of the absorbent assembly 228 configured to be inserted or extracted from the housing 216, the removable support 276 extending longitudinally from a first end. having the manipulation handle 266 up to its second end configured to be inserted into the housing 216 through the side access opening 256.

According to Figure 14 and Figure 15, the housing bottom 224 of the sampling device 212 comprises two opposite longitudinal walls and sufficiently spaced from each other so as to form a slide 278 configured to guide the removable support 276 of the absorbent assembly 228 during its insertion into the housing 216. The strip 230 comprising the reactive elements 232, 234 is configured to be arranged longitudinally at the bottom of the housing 224, each of the ends of the strip 230 being configured to be held in a notch 280, 282 of the housing bottom 224.

[0070] Optionally, the slide 278 and the removable support 276 of the absorbent assembly 228 may include means of immobilization of the stopper type of the removable support 276, so as to keep the absorbent assembly 228 immobile when the handle 266 for handling the removable support 276 is in abutment against the periphery of the lateral access opening 256 of the housing 216.

The face of the strip 230 comprising no reactive elements 232, 234 is configured to be arranged to bear against the housing bottom 224 facing an opening 252 extending longitudinally, of a length along the axis longitudinal L slightly less than that of the strip 30 and of a width, in a direction transverse to the longitudinal axis L, slightly less than that of the strip 230, so that the strip 230 can come to rest on the periphery of the opening 252 of the case back 224.

According to Figure 14, particularly in the third embodiment, the absorbent assembly 228 comprises a single absorbent element extending longitudinally and generally forming a parallelepipedal element. The single absorbent element may be, for example without limitation, of the reservoir blotting paper type. The single absorbent element acts as a diffusion band 238 and also allows the deposition of biological fluid. In other words, the single absorbent element comprises a portion 237 for depositing biological fluid and a diffusion band 238, the deposit portion 237 also being able to serve as a diffusion band 238.

According to Figure 14, for the purpose of facilitating the handling of the removable support 276, the removable support 276 is configured to hold the absorbent assembly 228 on its periphery so that its upper surface and its lower surface are directly accessible by the top or the bottom of the removable support 276. To this end, the removable support 276 comprises side walls 284 for retaining the absorbent assembly 228, each lateral retaining wall 284 comprising flanges 286 resting on the upper surface and on the lower surface of the absorbent assembly 228. To this end, the body fluid deposition portion 237 can be equally well defined on the upper or lower surface of the absorbent assembly 228 forming a single absorbent element, the diffusion band 238 which can be identified as either the upper surface or the lower surface of the absorbent assembly 228.

Optionally, it is possible to form on one of the faces of the absorbent assembly 228 patterns of the crenellated type as illustrated on the diffusion strip 38 of the first and of the second embodiment. To this end, a succession of zones reduced in thickness arranged successively along the longitudinal axis L on one face of the absorbent assembly 228 and each being separated by zones not reduced in thickness can form a diffusion strip 238 in the form of a crenel. . The surface of the absorbent assembly 228 opposite the diffusion band 238 can therefore be defined as a deposit portion 237, the biological liquid being able to diffuse from the surface. acting as a deposit portion 237 up to the surface acting as a diffusion band 238.

According to Figure 16 and Figure 17, according to the third embodiment, when the housing 216 is closed and the removable support 276 comprising the absorbent assembly 228 is entirely arranged in the housing 216, that is to say say when the handle 266 is in abutment against the periphery of the lateral access opening 256, the absorbent assembly 228 is not in contact with the reactive elements 232, 234 of the strip 230. The distance d according to l 'vertical axis V between the reactive elements 232, 324 and the surface of the absorbent assembly 228 forming the single absorbent element acting as a diffusion band 238 may be less than a millimeter, this distance d possibly corresponding to the thickness according to the vertical axis V of the flanges 286 of the supporting side walls 284 of the absorbent assembly 228.

For this purpose, therefore, the sampling device 212 does not on its own allow the biological fluid to come into contact with the reactive elements 232, 234. The sampling device 212 of the third embodiment is configured so that the biological fluid only comes into contact with the reactive elements 232, 234 when this sampling device 212 is inserted into the reader 14 for analyzing a sample of biological fluid.

For this purpose, according to Figure 16, the cover 226 of the housing 216 comprises at its right end, in the vicinity of the lateral access opening 256, an oblique sloping portion 288 of the bevel type extending upward. from the surface of the cover 226 to the side access opening 256. This oblique sloping portion is configured to abut against a wall of the reader 14 so as to slide progressively in vertical thrust downwards the sampling device 212 in contact with a stop internal to the analysis reader 14. Also, in order to bring the reactive elements 232, 234 into contact with the single absorbent element configured to diffuse the biological liquid on the reactive elements 232, 234, the internal stop of the analysis reader 14 is then configured to come overwrite. the strip 230 towards the absorbent assembly 228 during the vertical downward thrust of the sampling device 12, the reactive elements 232, 234 of the strip 230 then being in compressed contact between the absorbent assembly 228 and the strip 230 arranged in direct contact with a protuberance of the base of the analysis reader 14. When the strip 230 is crushed, the two ends of the strip 230 are each ejected from their notch 280, 282 of the case bottom 224 of the sampling device 212.

According to Figures 18, 19 and 20, a fourth embodiment of a sampling device 312 is shown. This fourth embodiment is a variant of the third embodiment. Housing 316 has a side access opening 356 arranged on the right side face of the right end of housing 316, similar to the third embodiment. The sampling device 312 comprises a handling handle 366 allowing the insertion in a longitudinal direction D1 and the extraction in a direction opposite to D1 complete of the absorbent assembly 328 of the housing 316. In addition, similarly to the third mode embodiment, the sampling device 312 comprises a removable support 376 of the absorbent assembly 328 configured to be inserted or extracted from the housing 316, the removable support 376 extending longitudinally from a first end comprising the handling handle 366 up to its second end configured to be inserted into the housing 316 through the side access opening 356.

According to Figure 19 and Figure 20, the housing 316 of the sampling device 312 comprises a top of the housing 324 and two longitudinal walls 323 opposite and sufficiently spaced from each other so as to form a slide 378 configured to guide the removable support 376 of the absorbent assembly 328 during its insertion into the housing 316. The strip 330 comprising the reactive elements 332, 334 is configured to be arranged longitudinally at the top of the housing 324 between the two longitudinal walls 323 forming the slide 378 of the removable support 376 of the absorbent assembly 328, each of the ends of the strip 330 being configured to be held in a notch 380, 382 of the top of the housing 324. According to the invention, it will be appropriate that the designation of top of housing or bottom housing of the housing of the biological fluid collection device can be considered as equivalent, the overall orientation of the collection device and the lec teur of the device being indications. These names simply allow an intuitive and clear description of the figures illustrating the invention. More generally, none of the overall orientations described for the sampling device is a limiting constraint on the invention.

[0080] Optionally, the slide 378 and the removable support 376 of the absorbent assembly 328 may include means of immobilization of the stopper type of the removable support 376, so as to keep the absorbent assembly 328 immobile when the removable support 376 is in abutment against the periphery of the lateral access opening 356 of the housing 316.

The removable support 376 comprises respectively from its first end to its second end, the handling handle 366 delimited by a guard element 377 preferably of trapezoidal shape and configured to close the opening of the reader housing in which provision is made to introduce the device 312 for biological sampling, then a reception area 379 configured to arrange therein an electronic identification tag 381 and forming a stop 383 of the removable support 376 against the housing 316 of the device 312 for sampling, and finally a support portion 385 of the absorbent assembly 328. The support portion 385 comprises a support tab 329 of the absorbent assembly 328, that is to say a tab 329 on which the absorbent assembly 328 rests, the support tab 329 which may include side walls 384 allowing the absorbent assembly 328 to be held on the tab 329. The housing 316 of the sampling device 312 ment not comprising a housing bottom, when the removable support 376 is inserted into the housing 316 of the sampling device 312, the support tab 329 of the absorbent assembly 328 acts as the housing bottom of the sampling device 312.

In a manner comparable to the third embodiment, the face of the strip 330 not comprising any reactive elements 332, 334 is configured to be arranged in abutment against the top of the housing 324 facing a plurality of openings 352, 354 from the top of the case 324. More particularly, in order to be able to read the change in color of the reactive elements 332, 334 arranged on the strip 330, each reactive element 332, 334 of the strip 330 is arranged, by transparency through strip 330, facing a single opening 352 of the plurality of top box openings 324, this single opening 352 being different from another top box opening 354 324 associated with another reactive element 334.

[0083] According to FIG. 19 and FIG. 20, in a manner comparable to the third embodiment, the absorbent assembly 328 comprises a single absorbent element extending longitudinally and generally forming a parallelepipedal element. The single absorbent element 328 may be, for example, without limitation, of the reservoir blotting paper type. The single absorbent element 328 acts as a diffusion band 338 and also allows the deposition of body fluid. In other words, the single absorbent element 328 includes a portion 337 for depositing biological fluid and a diffusion band 338, the deposit portion 337 acting as a diffusion band 338.

[0084] According to Figure 21, a transparent longitudinal section of the sampling device 312 and of a biological fluid sample analysis reader 314 according to the fourth embodiment is shown. When the housing 316 is closed, that is to say when the removable support 376 comprising the absorbent assembly 328 is arranged in abutment in the housing 316, the absorbent assembly 328 is not in contact with the reactive elements 332 , 334 of the strip 330. The distance d1 along the vertical axis V between the reactive elements 332, 324 and the surface of the absorbent assembly 328 acting as the diffusion band 338 may be less than a millimeter.

For this purpose, therefore, the sampling device 312 does not on its own allow contacting of the biological fluid with the reactive elements 332, 334. The sampling device 312 of the fourth embodiment is configured so that the biological fluid only comes into contact with the reactive elements 332, 334 when this sampling device 312 is inserted into the reader 314 for analyzing a biological fluid sample.

For this purpose, according to Figure 21, the right end of the support tab 329 of the absorbent assembly 328 comprises a bevelled portion 357 of thickness, along the vertical axis, greater than the rest of the tab 329 support, the bevelled portion comprising a downward slope towards the reception area 379 of the identification label 381. According to Figure 22, during the introduction according to a first thrust P1 of the sampling device 312, the bevelled portion 357 is configured to abut on a first boss 315 of the sample analysis reader 314 before its complete insertion in the sample analysis reader 314, that is, before the guard element 377 blocks the opening of the sample analysis reader housing 314. At this point, the absorbent assembly 328 is not in contact with the reactive elements 332, 334 of the strip 330.

According to Figure 23, when the insertion of the sampling device 312 goes beyond the stop formed by the first boss 315 of the sample analysis reader housing 314, that is to say during a second push P2 of the sampling device 312 until the opening of the sample analysis reader housing 314 is closed by the guard element 377 of the sampling device 312, the bevelled potion 357 is arranged by -above the first embossment 315 and causes the raising of the support tab 329 of the absorbent assembly 328 towards the reactive elements 332, 334 of the strip 330 so as to bring the absorbent assembly 328 into contact with the reactive elements. More particularly, when the bevelled portion 357 is pushed over the first embossment 315, the opposite longitudinal walls 323 forming the slide 378 of the removable support 376 move away from each other so as to release the removable support 376. of the slide 378, the removable support 376 being pushed by the first embossment 315 in the direction of the reactive elements 332, 334 of the strip 330.

It should be noted that the sample analysis reader 314 may include a second embossment 317 configured to also raise the free end of the support tab 329 of the absorbent assembly 328 towards the reactive elements 332, 334 of the strip 330 and therefore improve the contact between the absorbent assembly 328 towards the reactive elements 332, 334 of the strip 330.

Common to the four embodiments described, each housing 16, 116, 216, 316 of each sampling device 12, 112, 212, 312 may also include a lug arranged on a wall of the housing 16, 116, 216 , 316 so as to form a detection stop cooperating with a position sensor of the analysis reader 14, 314, thus allowing the reader 14, 314 analysis to check the presence or absence of the sampling device 12, 112, 212, 312 correctly arranged in the analysis reader 14, 314.

Also in common with the four embodiments described, each housing 16, 116, 216, 316 of each device 12, 112, 212, 312 can include an electronic identification tag arranged for example stuck on the cover 26, 126, 226, or even according to the fourth embodiment, stuck on the removable support 376, so as to guarantee traceability of each device 12, 112, 212 for sampling.

Also common to the four embodiments described, as illustrated in Figures 12, 13 and 14, the housing 216, more particularly the upper cover 226 of the housing can also include side guide fins 227 to facilitate inserting the sample cartridge into the analysis reader 14, 314. The guide fins 227 are configured to be able to cooperate with guide means specific to the analysis reader 14, 314.

It should be noted that according to the four embodiments described of the sampling devices 12, 112, 212, 312, the analysis reader 14, 314 of FIG. 1 can include several variants so as to be compatible with each embodiments. A non-limiting example is illustrated in Figures 21, 22 and 23.

It should be noted that the four embodiments described are particularly suitable for optical reading by reflection of light on each reactive element 32, 132, 232, 332 through the openings 52, 152, 252, 352 of the bottom of the case 24, 124, 224, or from the top of the case 324 and of the strip 30, 130, 230, 330 allowing the detection by the reader 14, 314 of analysis of a change in color of the reactive elements 32, 132, 232, 332 and therefore allowing the automatic analysis by the reader 14 of the properties of the sample of the biological fluid to be analyzed.

It should be noted that the invention is particularly advantageous for the analysis of biological fluid of the urine type. The reactive elements 32, 132, 232, 332 with a color change on contact with urine, can for example and without limitation, provide information relating to the monitoring of the acidity of urine via its hydrogen potential, noted pH, or the urine density and its creatinine concentration. Uric acid concentration is also a possible monitoring factor.

It must be understood that the detailed description of the subject of the invention, given solely by way of illustration, does not in any way constitute a limitation, the technical equivalents also being included in the scope of the present invention. .

Claims

Claim 1. Device (12, 112, 212, 312) for collecting a biological fluid sample intended to be inserted into a portable reader (14, 314) for analyzing the biological fluid, the device (12, 112, 212, 312) sample including:

- a transparent or translucent strip (30, 130, 230, 330) extending along a longitudinal axis (L) and comprising on its upper face a plurality of reactive elements (32, 132, 232, 332) with color change arranged one after the other along the longitudinal axis (L);

- an absorbent assembly (28; 128, 228, 328) extending along the longitudinal axis (L) and comprising o a portion (37, 137, 237, 337) for depositing biological fluid; o a diffusion band (38, 138, 238, 338) of the biological fluid arranged over the plurality of reactive elements (32, 132, 232, 332); a housing (16, 116, 216, 316) extending along the longitudinal axis (L) between two lateral ends, the housing (16, 116, 216) comprising: o a housing bottom (24, 124, 224, 324), the strip (30, 130, 230, 330) being arranged at the bottom of the case (24, 124, 224, 324), the lower face of the strip (30, 130, 230, 330) being arranged facing the case back (24, 124, 224, 324), each reactive element (32, 132, 232, 332) being arranged transparently through the strip (30, 130, 230, 330) facing an opening (52, 152, 252, 352) of the case back (24, 124, 224, 324); o an upper cover (26, 126, 226, 326) arranged over the diffusion strip (38, 138, 238), and comprising at least one protruding pattern (60, 172, 288) forming a first bearing surface configured to press the diffusion band (38, 138, 238, 338) into contact with the plurality of reactive elements (32, 132, 232, 332); o an access opening (56, 156, 256, 356) configured to access the portion (37, 137, 237, 337) for depositing biological fluid. Claim 2. Device (12, 112, 212, 312) according to claim 1, characterized in that the portion (37, 137, 237, 337) for depositing biological liquid is arranged through the access opening ( 56, 156, 256, 356).

Claim 3. Device (212, 312) according to any one of the preceding claims characterized in that the absorbent assembly (228) is a single blotting paper.

Claim 4. Device (12, 112) according to any one of claims 1 or 2 characterized in that

- the portion (37, 137) for depositing biological liquid comprises an absorbent reservoir strip (36, 136) separate from the diffusion strip (38, 138);

- the housing (16, 216) comprises a second bearing surface (64, 131) configured to press at least one contact portion (40, 140) of the reservoir absorbent strip (36, 136) in contact with a pad contact band (42, 142) of the diffusion band (38, 138).

Claim 5. Device (112) according to claim 4 characterized in that

- the absorbent reservoir strip (136) and the diffusion strip (138) are arranged generally longitudinally one after the other, the reservoir strip (136) being configured to be movable in translation along the longitudinal axis (L) ,

- the contact portion (140) is arranged at the end of the reservoir absorbent strip (136); the contact portion (140) being configured to strike the second bearing surface (131) by pushing along the longitudinal axis (L) of the reservoir absorbent strip (136) so as to be brought into contact with the contact pad (142) of the diffusion band (138).

Claim 6. Device (12, 112) according to any one of claims 4 or 5, characterized in that

- the diffusion strip (38, 138) and the absorbent reservoir strip (36, 136) respectively comprise a diffusion blotting paper and a reservoir blotting paper distinct from the diffusion blotting paper, the reservoir blotting paper comprising an absorption characteristic of liquid greater than that of diffusion blotting paper.

Claim 7. Device (12, 112, 212) according to any one of the preceding claims characterized in that - the diffusion band (38, 138, 238) comprises a plurality of reception areas (44, 144) arranged successively along the longitudinal axis (L), each reactive element (32, 132, 232) being arranged under a single reception area (44, 144), the diffusion band (38, 138, 238) comprising a material recess between each of the reception areas (44, 144).

Claim 8. Device (112, 212) according to any one of the preceding claims characterized in that

- The access opening (156, 256) is arranged on one of the lateral ends (220) of the housing (116, 216).

Claim 9. Device (212) according to claim 8 characterized in that the housing (216) comprises two opposite longitudinal walls internal to the housing (216) forming a slide (278) cooperating with a removable support (276) of the absorbent assembly. (228), the removable media (276) being configured to be inserted into the housing (224) through the access opening (256).

Claim 10. Device (12) according to any one of the preceding claims 1 to 7, characterized in that

- The access opening (56) is arranged on the cover (26) of the housing or on the housing base (24).