Sampling Device
The sample collection device addresses variability in fluid volume and user training issues by providing a one-handed, precise fluid transfer system for biological samples, ensuring reliable and contamination-free operation across various user groups.
Patent Information
- Application Number
- JP2025534673
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-12-19
- Filing Date
- 2023-12-18
- Publication Date
- 2025-12-05
AI Technical Summary
Existing fluid collection devices, particularly for blood, suffer from variability in collected volume, requiring specialized training for proper use and affecting assay sensitivity, especially when used by infants, children, the elderly, or intensive care patients.
A sample collection device with a support and head designed for one-handed operation, featuring a piston and capillary tube system that allows precise collection and expulsion of biological fluids into an analytical device without specialized training.
Ensures reliable, accurate, and easy collection and transfer of biological fluids, eliminating contamination risks and operational complexity, suitable for diverse user groups.
Smart Images
Figure 2025539604000001_ABST
Abstract
Description
[Technical Field]
[0001] The present disclosure relates to the field of fluid collection and analysis, and more particularly to the collection of liquids such as urine, saliva or blood. [Background technology]
[0002] The collection and transfer of fluids can be a complex task that existing device designs make handling more difficult than anticipated. Many devices used for rapid diagnostic tests, particularly in the case of blood, have been shown to have large variations in the volume of fluid collected by the device, resulting in the volume transferred usually being different from the intended volume, which can affect the sensitivity of the assay when the transferred volume is very small. Furthermore, sufficient training in their use is clearly required to avoid excessive variability. Summary of the Invention
[0003] It is an object of the present invention to provide a sample collection device comprising a support adapted to collect and expel a microbiological liquid, for example blood, said sample collection device further comprising a head adapted to cooperate with a spout of an analytical device such that cooperation of the head and the spout expels the microbiological liquid in the analytical device.
[0004] The disclosed sample collection device fills a gap by providing a reliable, easy-to-use, and economical collection and transfer device that can be used to puncture the skin or other tissue to collect biological fluids using only one hand without specialized training, which is highly useful when samples need to be collected from infants, children, adults, the elderly, and intensive care patients, requiring delicate and precise gestures.
[0005] Preferably, the head of the sampler cooperates closely with the spout of the analyzer.
[0006] According to the invention, the sampling device comprises a piston configured to move within the support between a first position in which the piston blocks an orifice in the support and a second position in which the piston is spaced from the orifice.
[0007] According to the invention, the head comprises a head base element and a pusher, the pusher being movable between a first position, referred to as an 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.
[0008] According to the invention, the piston is fixed to the head base element of the sampling device.
[0009] According to the invention, the support is fixed to the pusher.
[0010] According to the present invention, the head base element is positioned to receive the spout of the blood analyzer.
[0011] In accordance with the present invention, the sampling device includes a capillary tube pressed into one end of a capillary support.
[0012] According to the invention, the head is arranged to move relative to the capillary support.
[0013] According to the invention, the capillary support comprises an end provided with external fins, and the head comprises a hollow element intended to receive the end provided with external fins.
[0014] According to the invention, the capillary tube comprises an arrowhead-shaped end that is arranged to abut against the constriction of the analytical device.
[0015] The invention also relates to a system comprising a sampling device according to the invention and an analytical device comprising a spout.
[0016] Further features, details and advantages are set forth in the following detailed description and drawings. [Brief explanation of the drawings]
[0017] [Figure 1] 1 is a diagram showing a sample collecting device according to a first embodiment of the present invention inserted into an analysis device. [Figure 2] FIG. 2 is a perspective side view of the sample collection device of FIG. 1. [Figure 3] 3 is a longitudinal view of a detail of the sample collection device of FIG. 2 in a given position. [Figure 4] 3 shows a longitudinal view of a detail of the sample collection device of FIG. 2 in another position. [Figure 5] 3 shows a longitudinal view of a detail of the sample collection device of FIG. 2 in yet another position. [Figure 6] FIG. 10 is a perspective side view of a sample collection device according to another embodiment of the present invention during insertion into a blood analysis pouch (only one spout of the analyzer is shown). [Figure 7] FIG. 7 is a longitudinal view of the sample collection device of FIG. 6. [Figure 8] 8 shows a detailed view of the sample collection device of FIG. 7. [Figure 9] 8 shows a longitudinal view of the sample collection device of FIG. 7 in another position. [Figure 10] FIG. 10 shows a detailed view of the sample collection device of FIG. [Figure 11] 9 shows a detailed view of the sample collection device of FIGS. 7 and 8 when cooperating with the spout of an analytical device. [Figure 12] 11 shows a detailed view of the sample collection device of FIGS. 9 and 10 when cooperating with the spout of an analytical device. FIG. DETAILED DESCRIPTION OF THE INVENTION
[0018] 1 to 12 show a sample collection device 1, 100 according to the present invention, which is configured to collect a liquid sample (e.g., blood) from a puncture site and transfer it into a chamber of an analysis device 2, which may be a test cartridge or pouch.
[0019] 1, the analytical device 2, also referred to as an analytical pouch or test cartridge 2, in this example comprises two laminated films to which a fluidic circuit 3 is laser welded. The fluidic circuit 3 defines a number of communicating chambers 4 into which a liquid sample can flow from an inlet chamber 5 of the analytical device 2. Of course, the analytical device 2 can be configured in other ways, such as in the form of a rigid cartridge, without departing from the scope of the present invention.
[0020] As shown in Figure 1, the inlet chamber 5 of the analytical device 2 is provided with a spout 6. The sampling device 1, 100 is arranged to cooperate with the spout 6 as will be described below.
[0021] Next, a first embodiment of the sample collecting device 1 will be described in detail with reference to Figures 1 to 5. The liquid sample in this example is whole blood.
[0022] These figures show that the sampling device 1 comprises a head 7 and a body 8. The head 7 comprises a crimp cap 9. The body 8 comprises a capillary support 10 and a capillary 11 that is pressed into the capillary support 10.
[0023] The capillary tube 11 may be a standard plastic piece configured to contain, for example, 30 μL of blood. The capillary support 10 is preferably a plastic piece.
[0024] The capillary support comprises a body 12 provided with a pencil-shaped grip extending from a distal end 13 to a proximal end 14. The grip facilitates manipulation of the sample collection device 1 by a user.
[0025] The capillary support 10 holds the capillary tube 11 at its distal end 13. The capillary support 10 holds the crimp cap 9 at its proximal end 14. As can be seen in FIG. 1 , the distal end 13 is arrowhead-shaped and is fixed to act as a stop against the constriction 15 of the inlet chamber 5 when the capillary tube 11 is inserted into the cartridge 2.
[0026] As seen in Figures 1 and 2, the body 12 of the capillary support 10 extends along a longitudinal axis A, and the body 12 is cylindrical and has an outer diameter that decreases continuously from the proximal end 14 to the distal end 13.
[0027] The proximal end 14 of the capillary support 10 comprises several fins 16 (four in the illustrated embodiment, although the invention is not limited to such a number). The fins 16 are preferably arranged in diametrically opposed pairs. The fins 16 have an elongated shape and extend largely parallel to the longitudinal axis A over a length L16. The length L16 is shorter than the length L14 of the proximal end 14, and the fins 16 form the notched contact surface of the capillary support 10 against the crimp cap 9. The cross-sectional length of the capillary support 10 where the fins 16 are present is designated D16, and the cross-sectional length of the proximal end 14 beyond the fins 16 is designated D14, where D14 is less than D16.
[0028] The body 12 of the capillary support 10 extends between an outer wall 17 and an inner wall 18. As can be seen in Figures 3 to 5, one end 19 of the inner wall 18 is beveled. In other words, the end of the body 12 is conical.
[0029] As can also be seen in Figures 3 to 5, the crimp cap 9 comprises a body 20 provided with a hollow element 21 and a grip 22. The user operates the sample collection device 1 by means of the grip 22. The hollow element 21 defines a cylindrical cavity 23 with a central protrusion 24 protruding from a bottom 25 of the cavity 23. The protrusion 24 is positioned to receive the inner wall 18 of the capillary support 10. The diameter of the cavity 23 corresponds to the length D16.
[0030] As can be seen in Figures 1 and 2, the body 20 of the crimp cap 9 is formed to cooperate with the spout 6 of the inlet chamber 5. The bottom 25 of the hollow element 21 is disk-shaped and has a rim 26 arranged to rest on a rim 27 of the body 28 of the spout 6 when the sample collector 1 is inserted into the cartridge 2. The hollow element 21 is preferably cylindrical and has a first portion 29 and a second portion 30 passing through the axis A. A shoulder 31 is formed between the portions 29 and 30, and the outer diameter of the portion 30 is smaller than the outer diameter of the portion 29. The outer diameter of the portion 29 corresponds to the inner diameter of the spout 6 so that the cap 9 can be introduced into and placed on the body 28 of the spout 6.
[0031] The cap can be slid onto the capillary support 10 as described below.
[0032] In the first state shown in Figure 3, the capillary support 10 and the cap 9 are not sealed together. This is the vent position. As indicated by the arrows, air flow f can circulate freely between the cap 9 and the capillary tube 11 due to the beveled end 19 and notched contact surface of the body 12. Capillary action occurs within the capillary tube 11, which is pressed into the capillary support 10, allowing blood to be collected at this position.
[0033] After collecting the blood, the sample collection device 1 is inserted into the analysis device 2. When the arrowhead-shaped distal end 13 reaches the stop constriction 15 of the analysis device 2, the user moves the cap 9 forward on the capillary support 10, which is immobile in this configuration. Figure 4 shows an intermediate state in which the cap 9 has partially slid over the fins 16 of the capillary support 10. As the diameter of the cavity corresponds to the length D16, the pressure continuously increases during the translation of the cap 9 on the capillary support 10 and blood starts to be expelled (arrow b).
[0034] 5, the end 19 of the capillary support 10 abuts the bottom 24 of the cavity 23 in the cap 9. This is the sealed position. The blood is completely expelled from the sampling device 1 into the analysis device 2.
[0035] As a result of the crimp cap 9, capillary support 10, and capillary tube 11, the sample collection device 1 eliminates the possibility of contamination of the blood before or after it enters the analyzer. The sample collection device 1 does not require qualified medical personnel to handle the sample.
[0036] Next, another embodiment of the sampling device according to the present invention will be described in detail with reference to FIGS.
[0037] These figures show that the blood sampling device 100 comprises a head element 107 and a body 108 .
[0038] The body 108 includes a piston support 110 and a piston 111 disposed completely inside the piston support 110. That is, the sampling device 100 according to this embodiment is a positive displacement syringe.
[0039] As a positive displacement syringe, the piston 111 is arranged to move within the piston support between a first position in which the shaped end 140 of the piston 111 closes the orifice 141 in the piston support 110, and a second position in which the shaped end 140 is spaced apart from the orifice 141. The piston 111 constitutes the piston or piston of the sample collection device 100 and is in direct contact with the liquid to be collected, i.e., preferably blood. The amount of liquid drawn depends only on the dimensions of the piston support 110 and the displacement distance of the piston 111 between the first and second positions.
[0040] The piston 111 and the piston support 110 extend along a longitudinal axis A.
[0041] As can be seen in Figures 6 to 12, the head 107 comprises a head base element 142 and a pusher 143, which is movable between a first position, called an upper position, in which the pusher 143 is held so as to rest on an upper stop 144 of the head base element 142, and a second position, called a lower position, in which the pusher 143 is held so as to rest on a lower stop 145 of the head base element 142.
[0042] As can be seen, the piston 111 is secured to a head base element 142, and the piston support 110 is secured to a pusher 143, as will be described in more detail below.
[0043] The head base element 142 comprises a cylindrical portion 146 and an elongated portion 147 provided with three regularly spaced passages that serve to receive the pusher 143. The elongated portion 147 extends from the cylindrical portion 146 to a conical end 149.
[0044] The pusher 143 comprises three arms 152 extending longitudinally between a first end 153, referred to as the free end, and a second end 154, referred to as the inner end. Each of the three arms 152 comprises a cutout 155 for cooperating with the spout 6 of the inlet chamber 5, as will be explained in detail below. The cutouts 155 are located on the outside of the cylindrical portion 146. Each of the three arms 152 comprises a pin 156 for cooperating with upper and lower stops 144, 145 of the head base element 142. The pin 156 is locally perpendicular to the respective arm 152.
[0045] In the upper position, the free end 153 of the pusher 143 protrudes from the head base element 142 , and in the lower position, the free end 153 is completely inside the cylindrical portion 146 .
[0046] As can be seen, piston support 110 is overmolded onto second end 154 of pusher 143 such that pusher 143 and piston support 110 move together. Additionally, elongated portion 147 of head base element 142 is overmolded onto piston 111 such that piston 111 and portion 147 move together.
[0047] The spout 6 is shown in Figures 6, 11 and 12. It comprises a cylindrical portion 57 provided with a circular collar 58 and two side surfaces 59 extending from the cylindrical portion 57. The spout comprises a rib 60 arranged to be inserted into a notch 155 in the pusher 143.
[0048] 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 element 142 (FIGS. 7 and 8). In this position, the piston 111 and the piston support 110 are in a sealed position, i.e., the piston 111 blocks the orifice 141 in the piston support 110. To collect a blood sample, the user pushes the free end 153 from the upper position to the lower position, thereby moving the piston 111 away from the orifice 141. Blood is then drawn into the piston support 110.
[0049] To expel blood, the sampler 100 is introduced into the inlet chamber 5 until the collar 58 contacts the pin 56. Then, as the user continues to insert the sampler 100 into the analyzer 2, the collar 58 pushes against the pin 156 which slides to its upper position, causing the piston 111 to rise into the orifice 141 in the piston support 110 and expel blood from the sampler 100 into the inlet chamber 5.
[0050] The sample collection device 100 ensures accurate collection and release of blood volumes without trapping air between the tip of the piston 111 and the piston support 110. Furthermore, the sample collection device 100 is not affected by fluid viscosity. The sample collection device 100 can be operated with only one hand, making it easy to use and reliable.
[0051] It should be noted that the sample collection devices 1, 100 of Figures 1-12 may include a hydrophobic filter to improve ease of use and safety, particularly in the context of Clinical Laboratory Improvement Act (CLIA) exemptions.
[0052] As can be seen from the above description, the sample collection device of the present disclosure is simple to use as a result of the interaction between the cartridge spout and the head of the sample collection device, and the amount of blood collected and dispensed is accurate, ensuring reliable analytical results.
[0053] 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 needs to be collected and transported.
[0054] Naturally, the invention is not limited to the embodiments described and illustrated in the accompanying drawings: modifications are still possible, particularly in terms of the configuration of the various elements or the substitution of technical equivalents, without departing from the scope of protection of the invention as defined by the claims.
Claims
1. 1. A sample collection device (1, 100) comprising a support (10, 110) configured to collect and release a microbiological liquid, said sample collection device further comprising a head (7, 107) configured to cooperate with a spout (6) of said analysis device (2) such that cooperation between said head (7, 107) and said spout (6) releases the microbiological liquid inside said analysis device (2).
2. 2. The sampling device (100) of claim 1, comprising a piston (111) arranged to move within the support (110) between a first position in which the piston (111) closes an orifice (141) in the support (110) and a second position in which the piston (111) is spaced from the orifice (141).
3. 3. The sampling device (100) of claim 2, wherein the head (107) comprises a head base element (142) and a pusher (143), the pusher (143) being movable between a first position, referred to as an upper position, in which the pusher is held to rest against an upper stop (144) of the head base element (142), and a second position in which the pusher (143) is held to rest against a lower stop (145) of the head base element (142).
4. 4. The sampling device (100) of claim 3, wherein the piston (111) is fixed to the head base element (142) of the sampling device (100).
5. 4. The sampling device (100) of claim 2 or 3, wherein the support (110) is fixed to the pusher (143).
6. The sample collection device (100) of any one of claims 3 to 5, wherein the head base element (142) is arranged to receive the spout (6) of the blood analyzer.
7. 2. A sampling device (1) according to claim 1, comprising a capillary (11) pressed into one end of a capillary support (10).
8. 8. Sampling device (1) according to claim 7, wherein the head (7) is arranged to move relative to the capillary support (10).
9. 9. A sampling device (1) according to claim 8, wherein the capillary support (10) comprises an end provided with external fins (16), and the head (7) comprises a hollow element intended to receive the end provided with the external fins.
10. The sample collection device (1) according to any one of claims 7 to 9, wherein the capillary tube (11) has an arrowhead-shaped end (13) arranged to abut against a constriction (15) of the blood analysis device (2).
11. A system comprising a sampling device (1, 100) according to any one of claims 1 to 10 and an analysis device (2) having a spout (6).