Small volume collection container

Abstract

A specimen collection container assembly includes a collection tube having a first open end and a second open end, and an internal reservoir formed within the collection tube. The assembly further includes a cap configured to be couplable to the collection tube to enclose the first open end, and a plug configured to be couplable to the collection tube to enclose the second open end. The collection tube further includes a flat mouth portion extending 360° around the first open end.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 157,452, filed March 5, 2021, entitled “Small Volume Collection Container,” the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] This disclosure relates to a small-volume capillary sample collection container assembly for collecting, storing, and transferring blood or specimen samples obtained from a patient for medical diagnostic testing. More specifically, this disclosure relates to a container assembly for capillary collection and small-volume venous blood processing of blood samples from a patient's skin surface. The container assembly includes a collection tube having a flat 360° lip feature surrounding a top opening of the tube, suitable for collecting samples from the skin surface. The device also includes a specimen collection container assembly configured for automating clinical laboratory processes. Background Technology

[0004] Conventional capillary aspiration devices according to the prior art provide a microtube or aspiration container with a raised receiving lip or funnel feature that engages with the patient's punctured skin surface to aspirate a blood sample from a capillary located just below the skin surface. The internal aspiration cavity of such prior art aspiration containers is typically straight-walled. Therefore, a large amount of blood or sample is trapped on the sidewalls of the cavity due to surface tension during aspiration and transfer.

[0005] After collection, these tubes are sealed by a cap assembly positioned on the collection container. Conventional cap assemblies provide a flat bottom surface communicating with the collection chamber. Therefore, a significant amount of dead volume of sample is generated within the collection chamber during transfer, as neither the collection container nor the cap assembly adequately delivers or transfers the collected blood sample to the probe's aspiration orifice. As can be understood, conventional prior art collection devices generate a large amount of wasted sample and require significantly larger sample volumes compared to the actual sample volume needed to perform the diagnostic tests for which the collected sample was obtained. Sample volume is particularly important in capillary applications, where very small volumes of blood are typically collected and / or obtainable, and therefore avoiding any waste and / or providing improved instrument access for sample volume is especially crucial.

[0006] In addition, due to their shape factor and achievable sample column height, conventional existing technology collection containers using gel-based separation devices are difficult to automate and / or collect samples.

[0007] Furthermore, clinical laboratory processes using sample collection containers have become increasingly automated. Consequently, many standard capillary sample collection containers are incompatible with the automated front-end processes used to prepare samples for appropriate analysis. These front-end processes include sorting the containers by type and / or contents, adding features to the surface or with contents-specific additives, centrifugation, vision-based sample quality analysis, serum level analysis, decapping, sample aliquoting, and automated labeling of secondary tubes. Additionally, many standard capillary sample collection containers are incompatible with automated analytical procedures and are not sized to accommodate automated diagnostic and / or analytical probes or other sample extraction devices. Moreover, many standard capillary sample collection containers are incompatible with certain automated back-end processes used after sample analysis, such as resealing, storage, and retrieval. Summary of the Invention

[0008] Therefore, there is a need for a capillary sample collection container with an improved spout or opening to allow for easy blood droplet acquisition and containment, as well as improved automation compatibility. Additionally, there is a need for an improved reservoir that allows for easy collection of the acquired sample and reliable barrier separation of small-volume blood samples via, for example, a gel separator.

[0009] Additionally, there is a need for a sample collection container that is compatible with automated clinical laboratory processes, including front-end automation, automated analyzers, and / or back-end automation, thereby providing improved workflow efficiency compared to conventional manual handling.

[0010] According to embodiments of this disclosure, a sample collection container assembly is provided. The sample collection container assembly includes: a collection tube having a first open end and a second open end; an internal reservoir formed within the collection tube; and a cap configured to be engageable with the collection tube to close the first open end. The sample collection container assembly further includes a plug configured to be engageable with the collection tube to close the second open end, wherein the collection tube further includes a flat nozzle portion extending 360° around the first open end.

[0011] In some embodiments, the internal reservoir tapers from the first open end toward a circular bottom surface formed within the collection tube.

[0012] In some embodiments, the collection tube further includes a shovel portion formed within the inner wall surface near the flat mouth portion.

[0013] In some embodiments, the shovel portion is one of a V-shape, U-shape, S-shape, or reverse S-shape.

[0014] In some embodiments, the plug is configured to be connected to the acquisition tube via an interference fit.

[0015] In some embodiments, the plug is configured to be connected to the acquisition tube via a snap-fit ​​connection.

[0016] According to another embodiment of this disclosure, a sample collection tube is provided. The sample collection tube includes: a first open end; a second open end; an outer sidewall; and an inner reservoir formed within the outer sidewall. The sample collection tube further includes: a flat nozzle portion extending 360° around the first open end; and a spatula portion formed within the inner wall surface near the flat nozzle portion.

[0017] In some embodiments, the internal reservoir tapers from the first opening end toward the circular bottom surface.

[0018] In some embodiments, the shovel portion is one of a V-shape, U-shape, S-shape, or reverse S-shape.

[0019] Other details and advantages of the invention will become clear after reading the following detailed description in conjunction with the accompanying drawings, in which the same parts are always designated by the same reference numerals. Attached Figure Description

[0020] Figure 1 This is an exploded perspective view of a capillary collection container assembly for collecting blood samples, according to one aspect of this disclosure.

[0021] Figure 2A yes Figure 1 A side cross-sectional view of the capillary collection container assembly under conditions prior to centrifugation;

[0022] Figure 2B yes Figure 1 A cross-sectional view of the capillary collection container assembly on the other side after centrifugation.

[0023] Figure 3 yes Figure 1 A cross-sectional view of the capillary acquisition container assembly from another side, showing the various dimensions of the assembly;

[0024] Figure 4A It is used with Figure 1 A perspective view of a cylindrical cap used in conjunction with a capillary collection container assembly;

[0025] Figure 4B yes Figure 4A Side view of the hat;

[0026] Figure 4C yes Figure 4B The sectional view of the cap along line BB;

[0027] Figure 5A It is for use in accordance with one aspect of this disclosure. Figure 1 A cross-sectional view of the collection tube used in conjunction with the capillary collection container assembly;

[0028] Figure 5B yes Figure 5A A perspective view of the acquisition tube;

[0029] Figure 5C yes Figure 5A A perspective view of the opening and nozzle of the collection tube;

[0030] Figure 6 This is a perspective view of the opening and nozzle of the collection tube according to another aspect of this disclosure;

[0031] Figure 7 This is a perspective view of the opening and nozzle of the collection tube according to another aspect of this disclosure;

[0032] Figure 8 This is a perspective view of the opening and nozzle of the collection tube according to another aspect of this disclosure;

[0033] Figure 9 This is a perspective view of the opening and nozzle of the collection tube according to another aspect of this disclosure;

[0034] Figure 10 This is an exploded perspective view of a bottom plug for use with a collection tube, according to one aspect of this disclosure;

[0035] Figure 11 This is an exploded perspective view of a bottom plug for use with a collection tube, according to another aspect of this disclosure;

[0036] Figure 12 This is an exploded perspective view of a bottom plug for use with a collection tube, according to another aspect of this disclosure;

[0037] Figure 13 This is an exploded perspective view of a bottom plug for use with a collection tube, according to another aspect of this disclosure;

[0038] Figure 14 This is an exploded perspective view of a bottom plug for use with a collection tube, according to another aspect of this disclosure. Detailed Implementation

[0039] The following description is provided to enable those skilled in the art to make and use the aspects intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will remain apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of this disclosure.

[0040] For the purposes described below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives should be understood in relation to the orientation of the invention in the accompanying drawings. However, it should be understood that various alternative variations of the invention may be taken unless explicitly stated otherwise. It should also be understood that the specific devices shown in the drawings and described in the following description are merely exemplary aspects of the invention. Therefore, specific dimensions and other physical characteristics relating to the aspects disclosed herein should not be considered limiting.

[0041] refer to Figure 1 This illustration shows a capillary collection container assembly 10 for collecting blood samples according to one aspect of the present disclosure. The capillary collection container assembly 10 includes a collection tube 14 for collecting, storing, and ultimately transferring biological samples (including blood samples) for diagnostic testing. A cap 12 is disposed on the collection tube 14 to cover and seal the collection tube 14 and any sample contained therein. According to the illustrated embodiment, after a sample contained in the collection tube has been collected, the cap 12 is removably disposed and attached to the collection tube 14. In some embodiments, the shoulder or bottom annular portion 12 of the cap may include a cap alignment indicator 13. The cap alignment indicator 13 can be used to guide the user to properly align the cap 12 with the collection tube 14 to help ensure a secure seal of the cap 12 on the collection tube 14, thereby ensuring sample safety. In some embodiments, the alignment indicator feature may also be present on the collection tube 14, molded into the collection tube 14, or disposed on a tube label.

[0042] The collection tube 14 can be a biological sample collection container for proteomics, molecular diagnostics, chemical sampling, blood or other body fluid collection, coagulation sampling, hematological sampling, etc. In one embodiment, the collection tube 14 may be particularly suitable for receiving and storing body fluid samples. In yet another embodiment, the collection tube 14 is particularly suitable for receiving and storing blood from a patient, such as venous blood or capillary blood. As used herein, the term "patient" means a mammalian organism, and the collection tube 14 of this disclosure is intended for use in sample collection procedures performed in humans and / or animals.

[0043] Still referencing Figure 1The collection tube 14 is a microtube suitable for capillary collection of blood samples. This collection tube has overall external dimensions conforming to standard tubes (e.g., 13 mm × 90 mm) to ensure compatibility with standard testing instruments and / or automated processes. The collection tube 14 can be formed from suitable plastics or composite materials known to those skilled in the art, for example, by injection molding.

[0044] The collection tube 14 is defined by an outer sidewall 20 extending from the bottom 22 of the open tube to the opening lip portion 17. As will be described in further detail below, the collection tube 14 includes an upper nozzle portion 16 and an inner reservoir 28 defined by tapering sidewalls 18. In some embodiments, the inner reservoir 28 has an overall increased height-to-diameter ratio to produce a higher column of blood or sample within the collection tube 14 compared to conventional containers including inner reservoirs with constant diameters and straight walls, even when the volume of blood or sample collected is relatively low (e.g., 800 μL or less). Providing a higher column of blood or sample makes it easier for medical professionals or diagnosticians to identify the volume of blood or sample contained within the collection tube 14 in order to determine the amount of blood or sample collected or available. Additionally, the higher column of blood or sample within the inner reservoir 28 further enables reliable barrier separation of blood or sample components by means of a gel separator positioned, for example, after centrifugation. Furthermore, providing a higher column of blood or sample reduces “dead volume,” i.e., the volume of blood or sample lost or retained in the tube during direct aspiration from the tube. The increased column height also allows the tube to be compatible with certain sample volume detection systems that can be part of a variety of front-end automated systems. Additionally and / or alternatively, the column geometry can also take into account the aspiration probe and tip diameter, thereby allowing for successful probe travel with minimal opening or sidewall contact.

[0045] Additionally, the capillary collection container assembly 10 may also include a bottom plug 24. The bottom plug 24 is configured to engage with the collection tube 14 to effectively close the bottom 22 of the open tube. In this way, the collection tube 14, having an internal reservoir 28, can be readily formed, for example, by injection molding, while still maintaining the more conventional form factor of a collection tube. That is, the bottom plug 24 may be configured to provide a closed, rounded bottom to the collection tube 14, enabling the collection tube 14 to be used with existing automated supports and holders. In some embodiments, the bottom plug 24 is configured for a press-fit interference fit within the bottom 22 of the open tube to the collection tube 14. As will be described in further detail below, various features may be provided on the bottom plug 24 to provide this robust interference fit.

[0046] refer to Figure 2A and Figure 2B The image shows the collection container assembly 10 in its state before centrifugation. Figure 2A ) and the state after centrifugation ( Figure 2B A sectional view below. (e.g.) Figure 2A As shown, the cap 12 is configured to attach to the collection tube 14 around the upper opening portion 16 to effectively close and seal the inner reservoir 28. As described above, the upper portion of the collection tube 14 defines the inner reservoir 28 for collecting, containing, and ultimately transferring biological samples. The inner reservoir 28 extends from the circular bottom 34 to the opening lip portion 17 of the collection tube 14. In some embodiments, the inner reservoir 28 may be coated with one or more additives (e.g., clot activator, lithium heparin, anti-hemorrhagic additive, etc.) which are sprayed or otherwise injected into the collection tube 14 to protect the blood or sample contained within the collection tube 14 during storage or for other diagnostic purposes known to those skilled in the art.

[0047] The internal reservoir 28 is defined within a sidewall 18, wherein the sidewall 18 has a generally angled and circular profile terminating at a circular bottom 34. As described above, the angled and circular profile of the internal reservoir 28 allows for an increased overall height-to-diameter ratio to generate a taller blood or sample column within the collection tube 14, thereby providing better visualization and / or simplified collection of the sample collected within the internal reservoir 28, reducing “dead volume,” and compatibility with sample volume detection systems, etc. For example, in some embodiments, the internal sidewall 18 of the internal reservoir 28 may be angled between 2.5° and 10° relative to the central axis of the collection tube 14 from the circular bottom 34 to the opening lip portion 17, thereby providing a taller sample column compared to tubes with internal reservoirs having non-angled (or minimally angled) sidewalls. Additionally, probe access can be improved by providing an outward taper or angle from the opening lip portion 17 to the circular bottom 34.

[0048] refer to Figure 2A and Figure 2B The lower portion of the collection tube 14 includes a generally hollow or “false” bottom cavity 26 defined by the outer sidewall 20 of the collection tube 14, the open tube bottom 22, and the circular bottom 34. The “false” bottom cavity 26 of the lower portion of the collection tube 14 aids in the injection molding of the collection tube 14 by facilitating plastic flow. Furthermore, by extending the lower portion of the collection tube 14 in this manner, and also by providing a bottom plug 24 in the open tube bottom 22, the collection container assembly 10 can be more easily compatible with standard medical testing instruments and / or automated processes.

[0049] As mentioned above, Figure 2A A collection container assembly 10 in a pre-centrifugation state is depicted according to one aspect of this disclosure. In this state, an internal reservoir 28 can contain a gel separator material 32 at its bottom portion, and a sample 30 (e.g., a blood sample) with a bulk density lower than that of the gel separator material 32 is held above the gel separator material 32.

[0050] As is known in the art, after centrifugation of such a collection container holding, for example, a blood sample, the major components of the blood (i.e., plasma / serum and hematocrit, which is mainly composed of red blood cells) separate by density, with the denser hematocrit depositing at the bottom of the inner reservoir and the less dense plasma / serum collecting above it. Simultaneously, the gel separator material is configured to have a density between that of plasma / serum and hematocrit. Therefore, after centrifugation, the gel separator material forms a barrier between plasma / serum and hematocrit. Although the gel separator material has been shown and described herein, it should be understood that any suitable type of separator, such as a mechanical separator, or separation using a gel-microbead combination, can also be utilized according to some embodiments of this disclosure.

[0051] For example, refer to Figure 2B The image shows the collection container assembly 10 after centrifugation. (About...) Figure 2A The blood sample 30 shown and described separates into two main components after centrifugation: a plasma / serum fraction 36 and a hematocrit fraction 38. Furthermore, after centrifugation, gel separator material 32 migrates from the bottom portion of the internal reservoir 28 to form an effective barrier between the plasma / serum fraction 36 and the hematocrit fraction 38. Due to the reduced overall size of the internal reservoir 28 relative to the entire collection tube 14 and the tapered sidewalls 18 of the internal reservoir 28, the plasma / serum fraction 36 of the sample 30 is easily visible and accessible to the user for analyzer / probe aspiration, even when the collected capillary blood volume is relatively low.

[0052] Next, refer to Figure 3 Various dimensions of the acquisition container assembly 10 according to one aspect of this disclosure are shown. It should be understood that the dimensions provided are merely illustrative of some embodiments, and the acquisition container assembly 10 is not limited to such a range. Table 1 shown below provides various size ranges according to one embodiment:

[0053] Table 1:

[0054] A The length L1 of the tube with the cap 75 to 95 B The length L2 of the tube without the cap 70 to 90 C Internal storage length of the tube 35 to 55 D Pipe opening ID1 5 to 12 E Pipe opening OD1 5 to 12 F tube bottom ID2 3 to 9 G OD2 at the bottom of the tube 7 to 15 H OD tube 10 to 15 J Hat height 15 to 25

[0055] For example, from the perspective of Figure 3As is evident from the dimensions shown and described in Table 1, the overall length (C) of the internal reservoir 28 is significantly smaller than the overall length (B) of the collection tube 14, thereby enabling the collection tube 14 to handle small-volume samples while maintaining a conventional shape factor for use with standard medical testing instruments and / or automated processes. Furthermore, the tapered sidewalls 18, created by the significantly smaller bottom inner diameter (F) than the opening inner diameter (D), provide a higher blood or sample column, thereby allowing for improved sample visibility, sample collection, and / or barrier separation between sample components.

[0056] Next, refer to Figures 4A to 4C Details of a cap 12 according to one aspect of this disclosure are shown. The cap 12 is configured in a generally cylindrical shape, having a bottom annular portion 40 defining an opening 41, and a top annular surface 42. A plurality of vertically extending ribs 46 extend between the top annular surface 42 and the bottom annular portion 40. The ribs 46 can extend 360° around the cap 12 to provide easier gripping and removal of the cap during automated processing compared to conventional caps having a generally cylindrical shape and / or ribs extending less than 360° around the cap. However, it should be understood that more... Figures 4A to 4C The number of ribs 46 may be more or less. Additionally, the draft angle of the cap 12 can provide improved clamping of the cap 12 during automated "pick and place" clamping and / or cap removal processes, as can the axisymmetric design and diameter of the ribbed portion of the cap 12.

[0057] For specific references Figure 4C A cross-sectional view of the cap 12 is shown. Inside the top annular surface 42, the cap 12 may include a cavity portion 44 defined by sidewalls 45. The cavity portion 44 and the sidewalls 45 can be sized and configured for assembly with respect to... Figures 1 to 3 The upper nozzle portion 16 of the collection tube 14 shown and described is within the inner diameter, so that when the cap 12 is placed on the collection tube 14, the opening of the upper nozzle portion 16 is effectively closed / sealed.

[0058] Furthermore, adjacent to the bottom annular portion 40, the cap 12 may also include a downwardly extending sidewall portion 47, thereby creating a gap 48 between the bottom annular portion 40 and the sidewall portion 47. Although not shown, the cap 12 may be held in place on the collection tube 14 via a snap-fit ​​groove on the cap 12 and / or the collection tube 14, wherein the snap-fit ​​groove provides audible and / or tactile feedback to the user to confirm that the cap 12 is secured to the collection tube 14. Additionally, the cap base of the cap 12 may be used to effectively seal the contents of the internal reservoir 28 within the collection container assembly 10. Although the engagement between the cap 12 and the collection tube 14 is described herein as a snap-fit, it should be understood that the cap 12 and / or the collection tube 14 may be coupled by any suitable method, such as threaded engagement, bayonet engagement, etc.

[0059] Now for reference Figures 5A to 5C The acquisition tube 14 according to one aspect of this disclosure is shown in further detail.

[0060] As mentioned above, many existing collection tubes include one or more "shovel" features on or around the top lip portion of the collection tube. These shovels typically extend above the top lip portion, thus providing guidance for the user to collect blood samples into the collection tube. However, such shovels are generally disadvantageous because they sometimes make it difficult to collect an appropriate amount of sample, complicate the manufacturing process and / or tooling of the collection tube, and / or make it difficult to identify the tube type on automated systems, as most systems cannot easily identify such collection tubes.

[0061] However, as Figures 5A to 5C As shown, the collection tube 14 includes an opening lip portion 17 that is uniform (i.e., flat) along its entire circumference, thus avoiding various drawbacks of prior art collection tubes utilizing an extension shovel. Instead of an extension shovel, the collection tube 14 includes a generally V-shaped channel 50 formed in the inner surface of the upper mouth portion 16 at a natural angle to aid flow within the tube, wherein the channel 50 narrows as it extends from the opening lip portion 17 toward the inner reservoir 28 of the collection tube 14. To provide this configuration, the thickness of the channel lip portion 52 located within the channel 50 is less than the thickness of other areas of the opening lip portion 17. The reduced thickness of the channel lip portion 52 and the V-shaped aspect of the channel 50 provide the user with a clear indication of which portion of the collection tube 14 should be used to obtain a blood or sample.

[0062] When the channel 50 is used as a "shovel," the user can efficiently obtain a blood sample, allowing a sufficient amount of sample to be captured within the internal reservoir 28. Furthermore, because the opening lip portion 17 is flat along its entire circumference, the formation / manufacturing of the collection tube 14 is simplified.

[0063] Furthermore, the acquisition tube 14 is compatible with most existing tube type recognition and identification systems. That is, tube type recognition and identification systems generally include vision / camera systems that are taught to read unique tube outer contours, thereby appropriately identifying and classifying the tube for further analysis. By providing a flat opening lip portion 17 and unique shoulder and nose contours, the acquisition tube 14 aids this machine learning process by allowing the reading of similar axisymmetric contours regardless of how the acquisition tube 14 is rotated and / or positioned, for example, in a storage rack. Such a recognizable contour cannot be created for acquisition tubes with highly variable outer contours because what the vision / camera system will capture depends heavily on the tube's rotation during reading. Additionally, the external geometry of the acquisition tube 14 itself can be unique enough compared to other acquisition tubes, making it easier for the tube type recognition and identification system to identify the acquisition tube 14 and label it as a small-volume acquisition tube (and process it accordingly).

[0064] Next, refer to Figure 6 The image shows a collection tube 60 according to another aspect of this disclosure. The collection tube 60 is defined by an outer sidewall 62 extending from the bottom of the opening tube (not shown) to the opening lip portion 67. Although Figure 6 Not shown, but it should be understood that the internal storage is confined within the acquisition tube 60, similar to the above description. Figures 1 to 3 The internal reservoir 28 is described. Furthermore, the collection tube 60 includes an upper nozzle portion 64 leading to the internal reservoir, and an outer lip portion 65 configured to engage with a cap (not shown).

[0065] Related to the above text Figures 5A to 5C Unlike the described collection tube 14, which uses a V-shaped channel as a shovel, the collection tube 60 provides a 360° shovel configuration, where the entire circumference of the opening lip portion 67 can act as a shovel for obtaining sample specimens. In some embodiments, the opening lip portion 67 may be tapered and its thickness may be significantly less than the remaining portion of the wall thickness of the upper opening portion 64. For example, the wall thickness at the opening lip portion 67 may be between 0.3 mm and 0.6 mm, while the wall thickness of the other portions of the upper opening portion 64 may be between 0.75 mm and 1.25 mm. In this way, a user can use any portion of the opening lip portion 67 to obtain sample specimens. Because the opening lip portion 67 is flat over its entire circumference, the formation / manufacturing of the collection tube 60 is greatly simplified, and the collection tube 60 is more compatible with existing tube identification systems.

[0066] Now for reference Figure 7 The image shows a collection tube 70 according to another aspect of this disclosure. The collection tube 70 is defined by an outer sidewall 72 extending from the bottom of the opening tube (not shown) to the opening lip portion 76. Although Figure 7Not shown, but it should be understood that the internal storage is confined within the acquisition tube 70, similar to the above description. Figures 1 to 5C The internal reservoir 28 is described. Furthermore, the collection tube 70 includes an upper nozzle portion 74 leading to the internal reservoir, and an outer lip portion 75 configured to engage with a cap (not shown).

[0067] like Figure 7 As shown, the opening lip portion 76 is uniform (i.e., flat) along its entire circumference, thus avoiding various drawbacks of collection tubes using an extended shovel. Instead of an extended shovel, the collection tube 70 includes a generally U-shaped channel 78 formed in the inner surface of the upper mouth portion 74, wherein the channel 78 is uniform as it extends from the opening lip portion 76 toward the inner reservoir (not shown) of the collection tube 70. To provide this configuration, the thickness of the channel lip portion 77 defined by the channel 78 is less than the thickness of other areas of the opening lip portion 76. The reduced thickness of the channel lip portion 77 and the channel 78 provide the user with a clear indication of which portion of the collection tube 70 should be used to obtain a blood or sample. Furthermore, because the opening lip portion 76 is flat along its entire circumference, the formation / manufacturing of the collection tube 70 is greatly simplified, and the collection tube 70 is more compatible with existing tube identification systems.

[0068] Next, refer to Figure 8 The image shows a collection tube 80 according to another aspect of this disclosure. The collection tube 80 is defined by an outer sidewall 82 extending from the bottom of the opening tube (not shown) to the opening lip portion 86. Although Figure 8 Not shown, but it should be understood that the internal storage is confined within the acquisition tube 80, similar to the above description. Figures 1 to 3 The internal reservoir 28 is described. Furthermore, the collection tube 80 includes an upper nozzle portion 84 leading to the internal reservoir, and an outer lip portion 85 configured to engage with a cap (not shown).

[0069] like Figure 8 As shown, the opening lip portion 86 is uniform (i.e., flat) along its entire circumference. Therefore, instead of an extended shovel protruding from the opening lip portion 86, the collection tube 80 includes an "S-shaped bend" channel 88 formed in the inner surface of the upper mouth portion 84. This "S-shaped bend" channel allows the acquired sample to flow from the opening lip portion 86 toward the internal reservoir (not shown) of the collection tube 80 and provides the user with a visually distinct "shovel".

[0070] To provide this configuration, the thickness of the channel lip portion 87 defined by channel 88 is less than the thickness of other areas of the opening lip portion 86. Similarly, the reduced thickness of the channel lip portion 87 and channel 88 provide the user with clear indication of which portion of the collection tube 80 should be used to obtain a blood or sample. Furthermore, because the opening lip portion 86 is flat across its entire circumference, the formation / manufacturing of the collection tube 80 is greatly simplified, and the collection tube 80 is more compatible with existing tube identification systems.

[0071] Now for reference Figure 9 The image shows a collection tube 90 according to another aspect of this disclosure. The collection tube 90 is defined by an outer sidewall 92 extending from the bottom of the opening tube (not shown) to the opening lip portion 96. Although Figure 9 Not shown, but it should be understood that the internal storage is confined within the acquisition tube 90, similar to the above description. Figures 1 to 3 The internal reservoir 28 is described. Furthermore, the collection tube 90 includes an upper nozzle portion 94 leading to the internal reservoir, and an outer lip portion 95 configured to engage with a cap (not shown).

[0072] like Figure 9 As shown, the opening lip portion 96 is uniform (i.e., flat) along its entire circumference. Therefore, instead of an extended shovel protruding from the opening lip portion 96, the collection tube 96 includes a "reverse S-curve" channel 98 formed in the inner surface of the upper mouth portion 98. This "reverse S-curve" channel is similar to the "S-curve" channel 88 described above, but simply reverses the curvature of the channel wall. Channel 98 allows the acquired sample to flow from the opening lip portion 96 toward the internal reservoir (not shown) of the collection tube 90 and provides the user with a visually distinct "shovel".

[0073] To provide this configuration, the thickness of the channel lip portion 97 defined by channel 98 is less than the thickness of the other areas of the opening lip portion 96. This reduced thickness of the channel lip portion 97 and channel 98 provides the user with a clear indication of which portion of the collection tube 90 should be used to obtain a blood or sample. Furthermore, because the opening lip portion 96 is flat across its entire circumference, the formation / manufacturing of the collection tube 90 is greatly simplified, and the collection tube 90 is more compatible with existing tube identification systems.

[0074] Next, refer to Figures 10 to 14 Various embodiments for sealing the bottom of the collection tube via, for example, a plug are shown.

[0075] First refer to Figure 10 This further details the information provided above. Figures 1 to 3The plug 24 is described. Specifically, the plug 24 may include a circular bottom portion 102, a generally cylindrical body portion 104, and a tapered end portion 106. A plurality of ribs 108 may extend along at least a portion of the body portion 104. In some embodiments, the ribs 108 may be deflectable to act as crushed ribs when compressed, thereby providing a greater interference fit.

[0076] To seal the bottom 22 of the open tube of the acquisition tube 14, the plug 24 can be pressed into the bottom 22 of the open tube until the shoulder surface of the rounded bottom portion 102 meets the bottom 22 of the open tube. The tapered end portion 106 makes it easier to initially access the bottom 22 of the open tube, and the ribs 108 and / or sidewalls of the body portion 104 provide an interference fit with the acquisition tube 14. In this way, the bottom of the acquisition tube 14 can be sealed and provided with a rounded bottom, thereby making the acquisition tube 14 compatible with standard test equipment and / or automated processes.

[0077] Now for reference Figure 11 The diagram illustrates a plug 110 according to another embodiment. Similar to the plug 24 described above, plug 110 includes a circular bottom portion 112 and a generally cylindrical body portion 114. However, instead of multiple ribs, plug 110 includes an inset ring 116 positioned annularly around the body portion 114. Ring 116 is configured to engage a corresponding raised ring 118 positioned within the sidewall 20 of the collection tube 14 near the bottom 22 of the opening tube. In this way, the engagement between the inset ring 116 and the raised ring 118 provides a “click” or “tap” feedback when plug 110 is fully inserted into the bottom 22 of the opening tube. It should be understood that in alternative embodiments, the inset ring 116 may alternatively be configured as raised, while the raised ring 118 may be configured as inset.

[0078] To seal the bottom 22 of the open tube of the acquisition tube 14, the plug 110 can be pressed into the bottom 22 of the open tube until the inner ring 116 and the raised ring 118 engage. In this way, the bottom of the acquisition tube 14 can be sealed and provided with a rounded bottom, thereby making the acquisition tube 14 compatible with standard test instruments and / or automated processes.

[0079] Next, refer to Figure 12The diagram illustrates a plug 120 according to another embodiment. Similar to the plug 110 described above, the plug 120 includes a circular bottom portion 122 and a generally cylindrical body portion 124, and is configured for a snap-fit ​​connection with the collection tube 14. However, instead of the inset ring on the body portion 124, the plug 120 includes a plurality of protruding tabs 126 positioned annularly around the body portion 124. The protruding tabs 126 are sized and configured to engage with corresponding inset rings 127 positioned within the sidewall 20 of the collection tube 14 near the bottom 22 of the opening tube. In this way, the engagement between the protruding tabs 126 and the inset rings 127 provides a “click” or “tap” feedback when the plug 120 is fully inserted into the bottom 22 of the opening tube. It should be understood that in alternative embodiments, the protruding tabs 126 may alternatively be configured to be inset, while the inset rings 127 may be configured to be protruding.

[0080] To seal the bottom 22 of the open tube of the acquisition tube 14, the plug 120 can be pressed into the bottom 22 of the open tube until the protruding tab 126 and the inner ring 127 engage. A notch 125 can be provided on the rounded bottom portion 122 to allow for insertion and / or removal of the plug 120 using a tool. In this way, the bottom of the acquisition tube 14 can be sealed and provided with a rounded bottom, thereby making the acquisition tube 14 compatible with standard testing equipment and / or automated processes.

[0081] Now for reference Figure 13 The diagram illustrates a plug 130 according to another embodiment. Similar to the plug 120 described above, the plug 130 includes a bottom portion 132 and is configured for a snap-fit ​​connection with the collection tube 14 via a protruding tab and an inner ring. However, unlike the substantially cylindrical body 124, the plug 130 includes a pair of flanges 134 having protruding tabs 136 extending therefrom. The protruding tabs 136 are sized and configured to engage a corresponding inner ring 137 positioned within the sidewall 20 of the collection tube 14 near the bottom 22 of the opening tube. In this way, the engagement between the protruding tabs 136 and the inner ring 127 provides a “click” or “tap” feedback when the plug 130 is fully inserted into the bottom 22 of the opening tube. It should be understood that in alternative embodiments, the protruding tabs 136 may alternatively be configured to be recessed, while the inner ring 137 may be configured to be protruding.

[0082] Compared to a fully cylindrical body, the flange 134 reduces the clamping stress on the collection tube 14. Furthermore, unlike the plugs 24, 110, and 120 described above, plug 130 includes a partially flattened bottom surface 132, which is desirable in some cases because it allows the collection tube 14 to stand upright after the collection process is complete. In particular, providing a partially flattened bottom surface 132 to plug 130 can be especially advantageous in special care environments where standard supports for holding the tube may not be available.

[0083] To seal the bottom 22 of the open tube of the acquisition tube 14, the plug 130 can be pressed into the bottom 22 of the open tube until the protruding tab 136 and the inner ring 137 engage. In this way, the bottom of the acquisition tube 14 can be sealed and provided with a rounded bottom, thereby making the acquisition tube 14 compatible with standard test instruments and / or automated processes.

[0084] Next, refer to Figure 14 The image shows a plug 140 according to another embodiment. The plug 140 may include a generally circular bottom portion 142 and may be held within a collection tube 14 by an elastomeric O-ring 146. The O-ring 146 may be positioned about a generally cylindrical post 144 extending from the circular bottom portion 142. The post 144 may include a plurality of angled forks 145 extending therefrom, wherein the forks 145 are configured to engage a shoulder surface of the bottom portion 142 to hold the O-ring 146 in place.

[0085] To seal the bottom 22 of the open tube of the acquisition tube 14, the plug 140 is pressed into the bottom 22 of the open tube until the shoulder surface of the rounded bottom portion 142 meets the bottom 22 of the open tube, wherein the O-ring 146 is sized and configured to provide an interference fit with the acquisition tube 14. In this way, the bottom of the acquisition tube 14 can be sealed and provided with a rounded bottom, thereby making the acquisition tube 14 compatible with standard test equipment and / or automated processes.

[0086] The above text is about Figures 1 to 14 The described collection container can be used with any suitable automated sample analyzer. Examples of such analyzers include (but are not limited to) those from Roche Diagnostics. P512, P612, c501 c502 c602 e601 e602 e801 and / or e802; DxA, AU5800, DCX700AU, Dxl and / or Falcon from Beckman Coulter, Inc.; from Siemens Healthcare. SH CH and / or IA; from Ortho Clinical Diagnostics. And / or from Abbott's GLP, a3600, Alinity, and / or Architect.

[0087] While several embodiments of an apparatus for capillary collection of blood samples have been described in the foregoing detailed description, modifications and alterations can be made to these embodiments by those skilled in the art without departing from the scope and spirit of the invention. Therefore, the foregoing description is intended to be illustrative rather than restrictive. The invention described above is defined by the appended claims, and all changes to the invention falling within the meaning of the claims and their equivalents are included within their scope.

Claims

1. A sample collection container assembly, comprising: A collection tube, the collection tube having a first open end and a second open end; An internal storage device is formed within the acquisition tube; A cap, configured to be connected to the collection tube to close the first open end; as well as A plug configured to connect to the collection tube to close the second open end. The acquisition tube further includes: A flat lip margin portion, the flat lip margin portion extending 360° around the first opening end to define the opening of the first opening end; and A shovel portion, the shovel portion being formed in the flat lip portion and within the inner wall surface near the flat lip portion, wherein the shovel portion is formed at the flat lip portion and extends away from the flat lip portion toward the inner reservoir, and wherein the shovel portion is formed only around a portion of the circumference of the flat lip portion; The thickness of the flat lip portion within the spade portion is less than the thickness of the remaining portion of the flat lip portion outside the spade portion.

2. The component of claim 1, wherein the internal reservoir tapers from the first open end toward a circular bottom surface formed within the collection tube.

3. The component according to claim 1, wherein the shovel portion is one of a V-shape, U-shape, S-shape, or reverse S-shape.

4. The component of claim 1, wherein the plug is configured to be coupled to the acquisition tube by an interference fit.

5. The component of claim 1, wherein the plug is configured to be connected to the acquisition tube via a snap-fit ​​connection.

6. The component of claim 1, wherein the shovel portion includes a channel formed in the inner wall surface, the channel extending downward from the flat lip portion toward the inner reservoir.

7. The component of claim 6, wherein the channel narrows as it extends downward toward the inner reservoir from the flat lip portion.

8. The component of claim 6, wherein the channel is uniform as it extends downward toward the inner reservoir from the flat lip portion.

9. A sample collection tube, comprising: First open end; Second opening end; External sidewalls; An internal storage unit is formed within the outer sidewall; A flat lip margin portion, the flat lip margin portion extending 360° around the first opening end to define the opening of the first opening end; as well as A shovel portion, the shovel portion being formed in the flat lip portion and within the inner wall surface near the flat lip portion, wherein the shovel portion is formed at the flat lip portion and extends away from the flat lip portion toward the inner reservoir, and wherein the shovel portion is formed only around a portion of the circumference of the flat lip portion; The thickness of the flat lip portion within the spade portion is less than the thickness of the remaining portion of the flat lip portion outside the spade portion.

10. The sample collection tube according to claim 9, wherein the internal reservoir tapers from the first open end toward the circular bottom surface.

11. The sample collection tube according to claim 9, wherein the shovel portion is one of V-shaped, U-shaped, S-shaped or reverse S-shaped.

12. The sample collection tube of claim 9, wherein the shovel portion includes a channel formed in the inner wall surface, the channel extending downward from the flat lip portion toward the inner reservoir.

13. The sample collection tube of claim 12, wherein the channel narrows as it extends downward toward the inner reservoir from the flat lip portion.

14. The sample collection tube of claim 12, wherein the channel is uniform as it extends downward toward the inner reservoir from the flat lip portion.

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