Sample collection device

Abstract

The disclosure relates to a sample collection device (1, 100) comprising a support (10, 110) arranged to collect and release microbiological fluids, the sample collection device further comprising a head (7, 107), said head (7, 107) being configured to cooperate with a spout (6) of an analysis device (2) in such a way that the cooperation between the head (7, 107) and the spout (6) causes microbiological fluid to be released inside the analysis device (2).

Description

[0001] Sample collection device

[0002] Technical field

[0003] This disclosure relates to the field of fluid collection and analysis and, more preferably, to the collection of liquids such as urine, saliva or blood.

[0004] State of the art

[0005] Fluid collection and transfer can be complicated activities, with existing device designs making them more difficult to handle than expected. It has been shown that many devices used for rapid diagnostic tests have high variability in the volume of fluid collected by the devices, particularly in the case of blood, resulting in volumes usually transferred not being the intended volumes, and affecting the sensitivity of analyses when the transferred volume is very small. Furthermore, adequate training in their use is clearly necessary to avoid too much variability.

[0006] Subject of the invention

[0007] The object of the invention is to provide a sample collection device, comprising a support arranged to collect and release microbiological liquids, for example blood, the sample collection device further comprising a head, wherein said head is configured to cooperate with a spout of an analysis device in such a way that the cooperation of said head and said spout causes the release of microbiological liquid inside the analysis device.

[0008] The sample collection device of this disclosure fills a gap by providing a reliable, easy, and economical collection and transfer device. This sample collection device allows for the collection, by puncturing the skin or otherwise, of biological fluids using only one hand and without professional training, which is very advantageous when it is necessary to perform the collection on infants, children, adults, elderly, and intensive care patients, which requires delicate and precise gestures.

[0009] Preferably, the head of the sample collection device cooperates with the nozzle of the analysis device, by complementarity of shape. According to the invention, the sample collection device comprises a piston arranged to move in the support between a first position in which the piston blocks an orifice of the support and a second position in which the piston is spaced from said orifice.

[0010] According to the invention, the head comprises a head base element and a pusher, said pusher being movable between a first position, called the upper position, in which the pusher is held so as to rest on an upper stop of the head base element and a second position, in which the pusher is held so as to rest on a lower stop of the head base element.

[0011] According to the invention, the piston is attached to the head base element of the sample collection device.

[0012] According to the invention, the support is fixed to the pusher.

[0013] According to the invention, the head base element is arranged to receive the nozzle of the blood analysis device.

[0014] According to the invention, the sample collection device comprises a capillary tube pressed into one end of a capillary holder.

[0015] According to the invention, the head is arranged to move relative to the capillary support.

[0016] According to the invention, the capillary support comprises an end provided with external fins, the head comprising a hollow element intended to receive said end provided with external fins.

[0017] According to the invention, the capillary tube comprises an arrowhead-shaped end arranged to rest against a constriction of the analysis device.

[0018] The invention also relates to a system comprising a sample collection device according to the invention and an analysis device comprising a nozzle.

[0019] Brief description of the drawings

[0020] Other features, details and advantages will be presented in the following detailed description and in the figures, in which:

[0021] Figure 1 is a view of a sample collection device according to a first embodiment of the invention inserted into an analysis device. Figure 2 is a perspective side view of the sample collection device of Figure 1.

[0022] Figure 3 is a longitudinal view of a detail of the sample collection device of Figure 2 in a given position.

[0023] Figure 4 is a longitudinal view of a detail of the sample collection device of Figure 2 in an alternative position.

[0024] Figure 5 is a longitudinal view of a detail of the sample collection device of Figure 2 in yet another position.

[0025] Figure 6 is a perspective side view of the sample collection device according to another embodiment of the present invention, upon insertion into the blood testing bag (only a spout of the testing device being shown).

[0026] Figure 7 is a longitudinal view of the sample collection device of Figure 6.

[0027] Figure 8 is a view of a detail of the sample collection device of Figure 7.

[0028] Figure 9 is a longitudinal view of the sample collection device of Figure 7 in another position.

[0029] Figure 10 is a view of a detail of the sample collection device of Figure 9.

[0030] Figure 11 is a view of a detail of the sample collection device of Figures 7 and 8 when cooperating with a nozzle of the analysis device.

[0031] Figure 12 is a view of a detail of the sample collection device of Figures 9 and 10 when cooperating with the nozzle of the analysis device.

[0032] Description of embodiments

[0033] Figures 1 to 12 show a sample collection device 1, 100 according to the invention which is configured to collect and transfer a liquid sample (e.g. blood) from a puncture site into a chamber of an analysis device 2, which may be a test cartridge or a bag.

[0034] As can be seen from Figure 1, the analysis device 2, also called analysis pouch or test cartridge 2, comprises, in this example, two laminated films in which a fluid circuit 3 has been laser welded. The fluid circuit 3 delimits a plurality of communicating chambers 4 into which the liquid sample can flow from an inlet chamber 5 of the analysis device 2. Obviously, the analysis device 2 can be designed in another way such as in the form of a rigid cartridge or the like without departing from the scope of the invention.

[0035] As shown in Figure 1, the inlet chamber 5 of the analysis device 2 is provided with a spout 6. The sample collection device 1, 100 is arranged to cooperate with said spout 6, as will be described below.

[0036] A first embodiment of the sample collection device 1 is now detailed with reference to Figures 1 to 5. The liquid sample is whole blood in this example.

[0037] These figures show that the sample collection device 1 comprises a head 7 and a body 8. The head 7 comprises a crimped cap 9. The body 8 comprises a capillary holder 10 and a capillary tube 11 which is pressed into the capillary holder 10.

[0038] The capillary tube 11 may be a standard plastic component designed to hold 30 pL of blood, for example. The capillary holder 10 is preferably a plastic component.

[0039] The capillary holder comprises a body 12 provided with a pencil-shaped gripping portion which extends from a distal end 13 to a proximal end 14. Said gripping portion facilitates manipulations of the sample collection device 1 by a user.

[0040] The capillary holder 10 holds the capillary tube 11 in position on its distal end 13. The capillary holder 10 holds the crimped cap 9 on its proximal end 14. As can be seen from Figure 1, the distal end 13 has an arrowhead shape where the capillary tube 11 is fixed to act as a stop against a constriction 15 of the inlet chamber 5 when it is inserted into the cartridge 2.

[0041] As can be seen from Figures 1 and 2, the body 12 of the capillary support 10 extends along a longitudinal axis A, the body 12 being cylindrical and having an outer diameter decreasing continuously from the proximal end 14 to the distal end 13.

[0042] The proximal end 14 of the capillary support 10 comprises a plurality of fins 16 (four in the illustrated embodiment, although the invention is not limited to such a number). The fins 16 are preferably arranged to be diametrically opposed in pairs. The fins 16 have an elongated shape and extend mainly parallel to the longitudinal axis A over a length L16. Said length L16 is shorter than a length L14 of the proximal end 14 such that the fins 16 constitute a notched interface of the capillary support 10 with respect to the crimped cap 9. A length of a cross-section of the capillary support 10 where the fins 16 are present is designated D16, while a length of a cross-section of the proximal end 14 beyond the fins 16 is designated D14, D14 being less than D16.

[0043] The body 12 of the capillary support 10 extends between an outer wall 17 and an inner wall 18. As can be seen from Figures 3 to 5, one end 19 of the inner wall 18 is inclined. In other words, the end of the body 12 is conical.

[0044] As also seen in Figures 3 to 5, the crimped cap 9 comprises a body 20 provided with a hollow member 21 and a gripping portion 22. A user manipulates the sample collection device 1 by its gripping portion 22. The hollow member 21 defines a cylindrical cavity 23 provided with a central projection 24 which projects from a bottom 25 of the cavity 23. The projection 24 is arranged to receive the inner wall 18 of the capillary support 10. A diameter of the cavity 23 corresponds to the length D16.

[0045] As can be seen from Figures 1 and 2, the body 20 of the crimped cap 9 is formed to cooperate with the spout 6 of the inlet chamber 5. The bottom 25 of the hollow member 21 is disc-shaped and comprises an edge 26 which is arranged to rest on an edge 27 of a body 28 of the spout 6 when the sample collection device 1 is inserted into the cartridge 2. Preferably, the cylindrical hollow member 25 has a first portion 29 and a second portion 30 which pass through the axis A. A shoulder 31 is formed between the portions 29 and 30, an outer diameter of the portion 30 being smaller than an outer diameter of the portion 29. The outer diameter of the portion 29 corresponds to an inner diameter of the spout 6 such that the cap 9 can be inserted into the body 28 of the spout 6 and rest on this body.

[0046] The cap can slide onto the capillary support 10, as described below.

[0047] In a first state illustrated in Figure 3, the capillary holder 10 and the cap 9 are not sealed together. This is a ventilated position. As indicated by the arrows, an airflow f can circulate freely between the cap 9 and the capillary tube 11 due to the inclined end 19 of the body 12 and the notched interface. Capillary action is able to occur inside the capillary tube 11 pressed into the capillary holder 10 so that blood can be collected in this position.

[0048] After the blood has been collected, the sample collection device 1 is inserted into the analysis device 2. When the arrowhead-shaped distal end 13 reaches the stop constriction 15 in the analysis device 2, the user moves the cap 9 forward onto the capillary holder 10, which is then stationary in this configuration. Figure 4 illustrates an intermediate state in which the cap 9 has partially slid onto the fins 16 of the capillary holder 10. Since the diameter of the cavity corresponds to the length D16, the pressure increases continuously during the translation of the cap 9 on the capillary holder 10, and the blood begins to be expelled (arrow b).

[0049] In a final position shown in Figure 5, the end 19 of the capillary holder 10 rests against the bottom 24 of the cavity 22 of the cap 9. This is a sealed position. The blood is completely expelled from the sample collection device 1 to the analysis device 2.

[0050] By means of the crimped cap 9, the capillary holder 10 and the capillary tube 11, the sample collection device 1 eliminates the possibility of contamination, before the blood is in the analysis device or after that. The sample collection device 1 does not require trained healthcare professionals for sample handling.

[0051] Another embodiment of the sample collection device according to the invention is now detailed with reference to Figures 6 to 12.

[0052] These figures show that the blood sample device 100 comprises a head member 107 and a body 108.

[0053] The body 108 includes a plunger holder 110 and a plunger 111 disposed completely within the plunger holder 110. In other words, the sample collection device 100 according to this embodiment is a positive displacement syringe.

[0054] As a positive displacement syringe, the plunger 111 is arranged to move within the plunger holder between a first position in which a tip-shaped end 140 of the plunger 111 closes an orifice 141 of the plunger holder 110 and a second position in which the tip-shaped end 140 is spaced from the orifice 141. The plunger 111 constitutes a piston or plunger of the sample collection device 100 and is in direct contact with the liquid, i.e., preferably blood, which is being collected. The amount of liquid drawn up depends only on the dimensions of the plunger holder 110 and the distance by which the plunger 111 is moved between the first and second positions.

[0055] The piston 111 and the piston support 110 extend along the longitudinal axis A.

[0056] As can be seen from Figures 6 to 12, the head 107 comprises a head base member 142 and a pusher 143, the pusher 143 being movable between a first position, called the upper position, in which the pusher 143 is held so as to rest on an upper stop 144 of the head base member 142 and a second position, called the lower position, in which the pusher 143 is held so as to rest on a lower stop 145 of the head base member 142. As can be seen from the figures, the piston 111 is fixed to the head base member 142, while the piston support 110 is fixed to the pusher 143, as will be described in detail below.

[0057] The head base member 142 comprises a cylindrical portion 146 and an elongated portion 147 having three regularly arranged passages for receiving the pusher 143. The elongated portion 147 extends from the cylindrical portion 146 to a tapered end 149.

[0058] The pusher 143 comprises three arms 152 extending longitudinally between a first end, called the free end, 153, and a second end 154, called the inner end. Each of the three arms 152 comprises a notch 155 for cooperating with the spout 6 of the inlet chamber 5, as explained in detail below. The notch 155 is disposed outside the cylindrical portion 146. Each of the three arms 152 comprises a pin 156 for cooperating with the upper and lower stops 144, 145 of the head base member 142. The pin 156 is locally perpendicular to the respective arm 152.

[0059] In the upper position, the free ends 153 of the pusher 143 protrude from the head base member 142, while in the lower position, the free ends 153 are completely inside the cylindrical portion 146.

[0060] As can be seen from the figures, the piston support 110 is overmolded onto the second ends 154 of the pusher 143 such that the pusher 143 and the piston support 110 move together. Furthermore, the elongated portion 147 of the head base member 142 is overmolded onto the piston 111, such that the piston 111 and the portion 147 move together.

[0061] The spout 6 is illustrated in Figures 6, 11 and 12. It comprises a cylindrical section 57 provided with a circular flange 58 and two sides 59 extending from the cylindrical section 57. The spout comprises a rib 60 arranged to be inserted into the notches 155 of the pusher 143.

[0062] When using the sample collection device 100 to collect blood, the initial position corresponds to the upper position, in which the pusher 143 protrudes from the head base member 142 (Figures 7 and 8). In this position, the plunger 111 and the plunger holder 110 are in the sealed position, i.e., the plunger 111 closes the orifice 141 of the plunger holder 110. For collection of a blood sample, a user pushes the free ends 153 from the upper position to the lower position, which pulls the plunger 111 away from the orifice 141. Blood is then drawn into the plunger holder 110. For release of the blood, the sample collection device 100 is inserted into the inlet chamber 5 until the collar 58 is in contact with the pins 56.Then, when the user continues inserting the sample collection device 100 into the analysis device 2, the collar 58 pushes the pins 156 which slide to the upper position, and the piston 111 moves to the port 141 of the piston holder 110, which expels the blood from the sample collection device 100 to the inlet chamber 5.

[0063] The sample collection device 100 ensures the collection and release of a precise amount of blood, without air between the tip of the plunger 111 and the plunger holder 110. Furthermore, it is not sensitive to the viscosity of the fluid. The sample collection device 100 can be operated with only one hand, making it simple and reliable to use.

[0064] It should be noted that optionally, the sample collection device 1, 100 of Figures 1-12 includes a hydrophobic filter to improve ease of use as well as safety particularly in a Clinical Laboratory Improvement Amendments (CLIA) exemption context.

[0065] As can be seen from the above description, the sample collection device according to the present disclosure is easy to use due to the interactions between the cartridge nozzle and the head of the sample collection device. In addition, the amount of blood that is sampled and released is accurate, which ensures highly reliable analysis results.

[0066] It should be noted that the present disclosure is not limited to the analysis of blood samples but can be used for any liquid fluid that is to be collected and transferred.

[0067] Of course, the invention is not limited to the embodiments described and represented in the appended figures. Modifications remain possible, in particular from the point of view of the constitution of the various elements or by substitution of technical equivalents, without thereby departing from the scope of the protection of the invention defined by the claims.

Claims

Claims 1. A sample collection device (1, 100), comprising a holder (10, 110) arranged to collect and release microbiological liquids, the sample collection device further comprising a head (7, 107), wherein said head (7, 107) is configured to cooperate with a spout (6) of an analysis device (2) in such a way that the cooperation of said head (7, 107) and said spout (6) causes the release of microbiological liquid inside the analysis device (2).

2. A sample collection device (100) according to claim 1, comprising a piston (111) arranged to move in the holder (110) between a first position in which the piston (111) plugs an orifice (141) of the holder (110) and a second position in which the piston (111) is spaced from said orifice (141).

3. Sample collection device (100) according to the preceding claim, wherein the head (107) comprises a head base element (142) and a pusher (143), said pusher (143) being movable between a first position, called the upper position, in which the pusher is held so as to rest on an upper stop (144) of the head base element (142) and a second position, in which the pusher (143) is held so as to rest on a lower stop (145) of the head base element (142).

4. Sample collection device (100) according to the preceding claim, wherein the piston (111) is attached to the head base element (142) of the sample collection device (100).

5. A sample collection device (100) according to claim 2 or 3, wherein the holder (110) is attached to the pusher (143).

6. A sample collection device (100) according to claims 3 to 5, wherein the head base member (142) is arranged to receive the nozzle (6) of the blood testing device.

7. A sample collection device (1) according to claim 1, comprising a capillary tube (11) pressed into one end of a capillary holder (10).

8. Sample collection device (1) according to the preceding claim, wherein the head (7) is arranged to move relative to the capillary support (10).

9. Sample collection device (1) according to the preceding claim, wherein the capillary support (10) comprises an end provided with external fins (16), the head (7) comprising a hollow element intended to receive said end provided with external fins.

10. A sample collection device (1) according to any one of claims 7 to 9, wherein the capillary tube (11) comprises an arrowhead-shaped end (13) arranged to rest against a constriction (15) of the blood analysis device (2).

11. System comprising a sample collection device (1, 100) according to any one of claims 1 to 10, and an analysis device (2) comprising a nozzle (6).

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