Microscopic specimen management device for biological fluids

Abstract

To provide a biological fluid collection device.SOLUTION: A biological fluid collection device includes a collection module and an outer housing. The collection module includes a housing comprising a first end having a sample introduction opening, a second end having a sample dispensing opening, and a passageway extending between the sample introduction opening and the sample dispensing opening. A mixing chamber and a holding chamber are in fluid communication with the passageway such that a sample introduced into the sample introduction opening passes through the mixing chamber and subsequently enters the holding chamber. The biological fluid collection device further includes a closure covering the first end, a cap covering the second end and including a vented plug, and an activation member adapted to forcibly discharge the sample contained in the holding chamber out of the sample dispensing opening. The collection module is positioned inside the outer housing and the closure closes the open end of the outer housing.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a biological fluid sampling device, and more particularly, to a blood sampling device for taking a small sample of blood and dispensing a portion of the sample to a device intended or designed to analyze the sample, such as a point-of-care device or a near-patient testing device.

[0002] Cross-reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 130,878, filed on Mar. 10, 2015, entitled "Biological Fluid Micro-Sample Management Device", which is hereby incorporated by reference in its entirety.

Background Art

[0003] There is a need for an improved device that enables the collection of extremely small specimens, such as collection samples of less than 500 microliters for analysis, such as for point-of-care use in patients. Current devices require conventional sample collection followed by the use of a 1 ml syringe or pipette to transfer a small amount of blood sample to the acceptance port of a point-of-care cartridge, i.e., the acceptance port of the instrument. This open system approach results in not only an overcollection of the specimen required for a specified test procedure but also an increased risk of blood exposure to the personnel performing the test.

[0004] Therefore, it is desirable to have a blood sample collection and dispensing tool for point-of-care use that employs conventional automated blood collection while minimizing the exposure risk and includes a novel controlled sample dispensing function.

Summary of the Invention

Means for Solving the Problems

[0005] The present invention describes a biological fluid sampling device comprising a sampling module and an outer housing. The sampling module includes a housing having a first end with a sample introduction opening, a second end with a sample dispensing opening, and a passage extending between the sample introduction opening and the sample dispensing opening. A mixing chamber and a containment chamber are fluidly connected to the passage so that a sample introduced into the sample introduction opening passes through the mixing chamber and then enters the containment chamber. The sampling module further includes a closure covering the first end of the housing, a cap covering the second end of the housing with an exhaust plug, and an activation member for forcibly dispensing a sample contained in the containment chamber through the sample dispensing opening. The sampling module is positioned inside the outer housing, and the closure of the sampling module closes the open end of the outer housing.

[0006] The mixing chamber may contain an anticoagulant placed within it. The mixing chamber may also contain an open-cell foam.

[0007] The cap may include an exhaust plug, such as a porous plug, that allows air to pass through but prevents blood samples from passing through. The exhaust plug can stop the flow of blood samples into the collection device if the passage in the housing is filled with blood.

[0008] The mixing chamber may be positioned closer to the first end of the housing than the containment chamber, so that the blood sample introduced through the sample introduction opening before being sent to the containment chamber passes through the mixing chamber.

[0009] The containment chamber may be defined by an elastic sleeve surrounding a portion of the housing and a recess within the housing, and the activation member may be at least a portion of the elastic sleeve defining the containment chamber. When the cap is removed from the collection device and inward pressure is directed toward the recess within the housing toward the portion of the elastic sleeve defining the containment chamber, the blood sample in the containment chamber may be forcibly ejected from the sample dispensing port. [Brief explanation of the drawing]

[0010] [Figure 1] Figure 1 is a front perspective view of a biological fluid collection device having a collection module located within an outer housing, according to one aspect of the present invention. [Figure 2] Figure 2 is a perspective view of a partial cross-section of the biological fluid collection device shown in Figure 1. [Figure 3] Figure 3 is a front perspective view of a biological fluid collection device having a collection module located within an outer housing, according to another aspect of the present invention. [Figure 4] Figure 4 is a perspective view of a partial cross-section of the biological fluid collection device shown in Figure 3. [Figure 5A] Figure 5A is a perspective view of a partial cross-section of the biological fluid collection device of Figure 1, inserted into a tube holder, according to one aspect of the present invention. [Figure 5B] Figure 5B is a perspective view of a partial cross-section of the biological fluid collection device in Figure 1, showing the biological fluid sample flowing into the collection module through the tube holder. [Figure 5C] Figure 5C is a perspective view of a partial cross-section of the biological fluid collection device in Figure 1, removed from the tube holder, according to one aspect of the present invention. [Figure 5D] Figure 5D is a perspective view of a partial cross-section of the sampling module of the biological fluid sampling device in Figure 1, removed from the outer housing in Figure 1, according to one aspect of the present invention. [Figure 5E] Figure 5E is a perspective view of a partial cross-section of a cap removed from the collection module of the biological fluid collection device in Figure 1, according to one aspect of the present invention. [Figure 5F] Figure 5F is a perspective view of a partial cross-section of the activation member of the sampling module of the biological fluid sampling device in Figure 1, which is activated to dispense small amounts of biological fluid from the sampling module, according to one aspect of the present invention. [Figure 6] Figure 6 is a partial perspective view of the lower end of a biological fluid collection device having a biological fluid collection module located within an external collection housing, according to another aspect of the present invention. [Figure 7] Figure 7 is a perspective view of a partial cross-section of the lower end of the biological fluid collection device shown in Figure 6. [Figure 8] Figure 8 is a perspective view of a biological fluid collection device according to another aspect of the present invention. [Modes for carrying out the invention]

[0011] The following description is provided to enable those skilled in the art to manufacture and use the embodiments described and conceived for carrying out the present invention. However, various modifications, equivalents, alterations, and substitutes will be immediately apparent to those skilled in the art. All such modifications, alterations, equivalents, and substitutes are intended to be included in the spirit and scope of the present invention.

[0012] Hereinafter, for illustrative purposes, the terms “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” and “vertical,” and their derivatives, are used in relation to the present invention when they are oriented in a certain direction within the drawings. However, it should be understood that the present invention can be envisioned in various alternative forms unless otherwise explicitly stated. Furthermore, it should be understood that several specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Accordingly, specific dimensions and other physical features relating to the embodiments disclosed herein are not to be considered limiting.

[0013] Referring to Figures 1 and 2, the biological fluid collection device includes a collection module 10 located within an outer housing 34. The collection module 10 is designed to receive biological fluid samples such as blood samples and includes a housing 12, a closure 14, a mixing chamber 16, a containment chamber 18, a cap 20, and an activation member 22.

[0014] In one embodiment, the housing 12 includes a first end 24, a second end 26, and a passage 28 extending between them, providing fluid communication between the first end 24 and the second end 26 of the housing 12. The passage 28 has a sample introduction opening 30 at the first end 24 of the housing 12 and a sample dispensing opening 32 at the second end 26 of the housing 12. A mixing chamber 16 and a containment chamber 18 are provided in fluid communication with the passage 28. The mixing chamber 16 and the containment chamber 18 are positioned so that a biological fluid sample, such as a blood sample introduced into the sample introduction opening 30 of the passage 28, first passes through the mixing chamber 16 and then enters the containment chamber 18 before reaching the sample dispensing opening 32 of the passage 28. In this way, the blood sample can be mixed with an anticoagulant or other additive provided in the mixing chamber 16 before the stabilized sample is received and stored in the containment chamber 18.

[0015] The mixing chamber 16 allows for passive mixing of the blood sample with an anticoagulant such as a blood stabilizer or other additive as the blood sample flows through the passage 28. The interior of the mixing chamber 16 can have any suitable structure or form, as long as the appropriate structure or form allows for mixing of the blood sample with the anticoagulant or other additive as the blood sample passes through the passage 28. The mixing chamber 16 may contain a dry anticoagulant such as heparin or EDTA attached to or inside the mixing chamber 16. The mixing chamber 16 may include, for example, an open-cell foam (Figure 1) containing a dry anticoagulant dispersed within the bubbles of the open-cell foam, thereby enhancing the effectiveness of flow-through mixing and anticoagulant uptake.

[0016] The open-cell foam can be treated with an anticoagulant to form a finely distributed dry anticoagulant powder throughout the pores of the open-cell foam. When a blood sample enters the mixing chamber 16, the blood sample passes through the open-cell foam and is exposed to the anticoagulant powder available throughout the pore structure inside the open-cell foam.

[0017] The continuous bubble foam may be a melamine foam that is inert to blood, soft and deformable, such as the Basotect® foam commercially available from BASF, or may be composed of a formaldehyde-melamine-sodium bisulfite copolymer. The continuous bubble foam may also be a flexible and hydrophilic continuous bubble foam that is substantially resistant to heat and organic solvents. In one embodiment, the foam may include a sponge material.

[0018] Anticoagulants or other additives may be introduced into the continuous bubble foam by immersing the foam in a solution of the additive and water and then evaporating the moisture to form a finely distributed dry additive powder throughout the internal structure of the foam.

[0019] After passing through the mixing chamber 16, the blood sample can be directed towards the storage chamber 18. The storage chamber 18 can take any suitable shape and size to store a sufficient amount of blood required for the desired test, for example, blood of 500 μl or less. In the embodiments shown in FIGS. 1 and 2, the storage chamber 18 is defined by a portion of the housing 12 in combination with an elastic sleeve 40 fixed around the outside of the housing 12. The elastic sleeve 40 can be made of any material that is flexible, deformable, and capable of providing a fluid-tight seal to the housing 12, including but not limited to natural rubber or synthetic rubber, and other suitable elastic materials. The housing 12 includes a recess 42 that extends from the outside of the housing 12 to the passage 28, effectively creating an opening in the housing 12 that is in fluid communication with the passage 28. The elastic sleeve 40 covers the recess 42 and defines a storage chamber 18 having an internal filling volume of 500 μl or less.

[0020] A cap 20 positioned at the second end 26 of the housing 12 covers the sample outlet 32 ​​of the passage 28. The cap 20 includes an exhaust plug, such as a porous plug 44, extending from the inner surface of the cap 20 to the outer surface of the cap 20. The structure of the exhaust plug 44 allows air to pass through the cap 20 while preventing blood sample from passing through, and may also include a hydrophobic filter. The exhaust plug 44 has a selected air passage resistance, which can be used to finely control the filling rate of the passage 28. By changing the porosity of the plug, the rate of air outflow from the cap 20, and therefore the rate of blood sample inflow into the collection module 10, can be controlled. If the rate of blood sample inflow into the collection module 10 is too fast, hemolysis may occur. If the rate of blood sample inflow into the collection module 10 is too slow, the sample collection time may become excessively long.

[0021] The closure 14 engages with the first end 24 of the housing 12 to seal the passage 28. The closure 14 allows for the introduction of a blood sample into the passage 28 of the housing 12 and may also include a perforated self-sealing stopper 36 with an outer protective element 38, such as a Hemogard® cap commercially available from Becton, Dickinson and Company. The closure 14 is also fixed to an outer housing 34, which may be a vacuum-filled blood collection tube, such as a Vacutainer® blood collection tube commercially available from Becton, Dickinson and Company.

[0022] The cap 20, positioned at the second end 26 of the housing 12, may also include a flange 46 to assist the user in removing the cap 20 from the housing 12. As shown in Figure 2, the flange may have an outer diameter less than the inner diameter of the outer housing 34 into which the sampling module 10 may be placed. Alternatively, as shown in Figures 6 and 7, the flange 46 may have an outer diameter substantially equal to the inner diameter of the outer housing 34. In this configuration, the flange 46 may include a recess or groove 48 extending from the upper surface to the lower surface, allowing the vacuum within the outer housing 34 to bypass the flange 46. Furthermore, as shown in Figures 6 and 7, the flange 46 may be made of an optically transparent material and may have a convex outer surface to magnify and show the exhaust plug 44 area of ​​the cap 20, allowing the physician to know when the blood sample has completely filled the passage 28 and reached the cap 20. The flange 46 may also engage with a recess in the inner wall of the outer housing 34 to restrain the cap 20 together with it.

[0023] For use, the needle cannula 50 (Figures 5A and 5C) is inserted into the passage 28 of the housing 12 through the sample introduction opening 30, such as the perforated self-sealing stopper 36 of the closure 14. As shown in Figure 5A, the combined sampling module 10 and outer housing 34 can be inserted into a conventional tube holder 52 having a cannula through which biological fluids are passed.

[0024] The biological fluid sample is drawn from the conventional tube holder 52 into the passage 28 of the housing 12 by the vacuum drawn inside the outer housing 34 (Figure 5B). The blood sample first enters the mixing chamber 16 and then the containment chamber 18, filling the entire passage 28 by expelling any air present in the passage 28 into the outer housing 34. As described above, as the biological fluid sample passes through the mixing chamber 16, it is exposed to and mixed with an anticoagulant or other additive. The cap 20 stops the collection of the blood sample when the passage 28, mixing chamber 16, and containment chamber 18 of the collection module 10 are completely filled. The exhaust plug 44 of the cap 20 prevents blood from entering the outer housing 34.

[0025] Once sample collection is complete, the outer housing 34 containing the sampling module 10 is separated from the tube holder 52 (Figure 5C), and then the outer housing 34 is separated from the sampling module 10 by removing the closure 14, which is still attached to the sampling module 10, from the outer housing 34 (Figure 5D). Removal of the closure 14 can be achieved by the user grasping both the outer protective 38 of the closure 14 and the outer housing 34 and pulling or twisting them in opposite directions.

[0026] Once the collection module 10 is separated from the outer housing 34, the cap 20 can then be removed from the collection module 10 (Figure 5E), exposing the second end 26 of the housing 12. Removal can be achieved by the user grasping the flange 46 and pulling the cap 20 away from the housing 12. The blood sample is retained in the passage 28 of the housing 12 by capillary action after the cap 20 is removed. Alternatively, the removal of the cap 20 may occur in conjunction with the removal of the collection module 10 from the outer housing 34. In this configuration, the cap 20 is constrained within the outer housing 34 by the interaction between the flange 46 and the corresponding recess in the outer housing wall. In further embodiments, the cap 20 may be connected to the outer housing 34 so that the outer housing 34 and the cap 20 can be removed in one step.

[0027] Next, the blood sample is dispensed from the collection module 10 by activating the activation member 22, such as by applying inward pressure in the direction of the arrow to the portion of the elastic sleeve 40 covering the containment chamber 18, thereby forcibly removing the blood sample from the containment chamber 18 and passing it through the sample dispensing port 32 (Figure 5F). In this way, the blood sample can be transferred to a device intended for analyzing the sample, such as a point-of-care testing device like a cartridge tester, or via a port, while minimizing physician exposure to the blood sample.

[0028] Although a portion of the elastic sleeve 40 is illustrated and described as partially defining the containment chamber 18 and functioning as an activation member 22 for dispensing a blood sample from the collection module 10, other alternative configurations are conceivable to achieve similar results. For example, the containment chamber 18 may be entirely defined by the housing 12, or a separate operating device engaged with the containment chamber 18, including but not limited to a plunger, push button, slide, etc., may be activated to dispensing a blood sample.

[0029] In another embodiment shown in Figures 3 and 4, the closure 14 may have a Luer lock connector 54 that passes through the stopper 36. This configuration is useful when drawing blood samples from an artery, where the vacuum required for venous blood collection is not needed to draw the blood sample into the collection module 100. The collection module 100 is used in the same way as the collection module 10, except that the Luer lock connector 54 is used to connect the collection module 100 to a wing set or other collection means having a mating Luer lock connector to introduce the blood sample into the passage 28.

[0030] Furthermore, the collection modules 10, 100 may be used without the outer housing 34. In the case of collection module 10, a syringe or other power source may be used to draw the sample into collection module 10. In addition, although the description herein has focused on using collection modules 10, 100 to collect blood samples and mix them with anticoagulants or other additives, collection modules 10, 100 may be used to collect any liquid samples, such as other body fluids, or to achieve mixing and dispensing of samples that have been collected in advance by other means.

[0031] In a further configuration, the sampling module 10 may include labels 56a, 56b attached to both the closure 14 and the outer housing 34, which need to be broken in order to remove the sampling module 10 from the outer housing 34. As shown in Figures 1 to 4, label 56a may be a strip extending only along a portion of the outer circumference of the closure 14 and the outer housing 34. By twisting the closure 14 against the outer housing 34, the strip is broken at the point where the strip transitions from the outer housing 34 to the closure 14. Perforations 58 may be provided in label 56a at the point where it transitions from the outer housing 34 to the closure 14 to assist in the strip breaking when the closure 14 is twisted. Alternatively, as shown in Figure 8, label 56b may surround the entire circumference of both the closure 14 and the outer housing 34. Perforations 58 are provided in the label 56b at the point where the label 56b transitions from the outer housing 34 to the closure 14, forming a band 60 around the closure 14 that can be separated from the portion of the label 56b surrounding the outer housing 34. By removing the band 60 from the closure 14, the closure 14 can be removed from the outer housing 34. A pull tab 62 may be provided on the band 60 to assist in separating the band 60 from the portion of the label 56b surrounding the outer housing 34.

[0032] While specific embodiments of the apparatus of this disclosure have been described in detail, it will be understood by those skilled in the art that various modifications and substitutions to those details can be developed in light of the overall teachings of this disclosure. Accordingly, the specific configurations disclosed are merely illustrative and are not intended to limit the scope of the apparatus of this disclosure and any equivalents that will be given by the entirety of the appended claims.

Claims

1. A biological fluid sampling device, An outer housing having an open end and a closed end, A module for sampling, A housing comprising: a first end having a sample introduction opening; a second end having a sample dispensing opening; a passage extending between the sample introduction opening and the sample dispensing opening; and a housing chamber having fluid communication with the passage; A closure covering the first end of the housing, wherein the closure includes a closure that closes the open end of the outer housing, A cap covering the second end of the housing and having an exhaust plug, The sampling module includes an activation member that causes the liquid sample contained in the containment chamber to be pushed out from the sample dispensing port, The sampling module is removably positioned inside the outer housing, A biological fluid sampling device in which air passes through the outer housing from the passage of the sampling module through the cap and the exhaust plug, while the cap prevents liquid samples from passing through them.

2. The biological liquid sampling apparatus according to claim 1, further comprising a mixing chamber that is in fluid communication with the aforementioned passage.

3. The biological fluid sampling apparatus according to claim 2, wherein the mixing chamber contains an anticoagulant adhering to the inside of the mixing chamber.

4. The biological liquid sampling apparatus according to claim 2, wherein the mixing chamber is filled with an open-cell foam.

5. The biological liquid sampling apparatus according to claim 2, wherein the mixing chamber is positioned closer to the first end of the housing than the containment chamber, so that the liquid sample introduced from the sample introduction opening passes through the mixing chamber before passing through the containment chamber.

6. The biological fluid sampling apparatus according to claim 1, wherein the containment chamber is defined by an elastic sleeve surrounding the housing and a recess in the housing.

7. The biological liquid sampling apparatus according to claim 6, wherein the activation member is at least a part of the elastic sleeve defining the storage chamber, such that when the cap is removed from the sampling module, inward pressure is applied to the portion of the elastic sleeve defining the storage chamber toward the recess of the housing, causing the liquid sample in the storage chamber to be pushed out from the sample dispensing port.

8. The biological fluid sampling apparatus according to claim 1, wherein the exhaust plug is a porous plug.

9. The biological liquid sampling apparatus according to claim 1, wherein the inside of the outer housing surrounding the sampling module is a vacuum.

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