Bodily fluid collection tube devices and associated methods and systems

Abstract

Bodily fluid collection tube devices for use with a centrifuge and associated methods and systems are disclosed. A bodily fluid collection tube includes a tube section and a cap section. The tube section includes a first end portion and section end portion opposite the first end portion, with a lumen extending therebetween. The lumen is configured to receive a volume of whole blood and a volume of gel. The cap section includes a first portion and a second portion configured to be positioned in contact with an interior surface of the first end portion of the tube section when the cap section is engaged with the tube section. The second portion of the cap section defines a cavity configured to receive a volume of red blood cells and a volume of the gel, where the red blood cells are derived from the volume of whole blood.

Description

130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOOBODILY FLUID COLLECTION TUBE DEVICESAND ASSOCIATED METHODS AND SYSTEMSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 697,024, filed September 20, 2024, which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present technology' is related to collecting bodily fluid from a subject and, in particular, to bodily fluid collection devices and associated methods and systems.BACKGROUND

[0003] Devices, systems, and methods to collect bodily fluids, such as blood, are widely used in personalized, clinical, and field medical applications. Biological samples are commonly collected using simple lancing devices or more sophisticated devices that require trained personnel (e.g., phlebotomy venipunctures). Transferring bodily fluids to a container, receptacle, or an analysis device often requires several steps, which can be time consuming, prone to error, and / or cumbersome. Moreover, many personalized devices designed for untrained users risk producing unreliable and / or unusable samples due to high probabilities of contamination, poor sample qualities, and / or insufficient sample volumes, which in turn limit the applicability of such devices.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present technology.

[0005] Figure 1A is a perspective view of a bodily fluid collection device configured in accordance with embodiments of the present technology.

[0006] Figure IB is a perspective view of the bodily fluid collection device of Figure 1 A during use in accordance with embodiments of the present technology.130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO

[0007] Figure 1C is a perspective view illustrating detachment of a collection tube from the bodily fluid collection device of Figures 1A and IB in accordance with embodiments of the present technology.

[0008] Figure 2A is a cross-sectional side view of a collection tube configured in accordance with embodiments of the present technology.

[0009] Figure 2B is a cross-sectional side view of the collection tube of Figure 2A at an intermediate processing stage before centrifugation.

[0010] Figure 3A is a cross-sectional side view of a collection tube configured in accordance with additional embodiments of the present technology7.

[0011] Figure 3B is a cross-sectional side view of the collection tube of Figure 3A at an intermediate processing stage before centrifugation.

[0012] Figures 4A and 4B are partial cross-sectional side views of a collection tube configured in accordance with embodiments of the present technology.

[0013] Figures 4C and 4D are partial cross-sectional side views of a collection tube configured in accordance with embodiments of the present technology.

[0014] Figure 5 is a cross-sectional side view of a collection tube configured in accordance with embodiments of the present technology.

[0015] Figure 6 is a cross-sectional side view of a collection tube configured in accordance with embodiments of the present technology.

[0016] Figures 7A and 7B are cross-sectional side views of a collection tube configured in accordance with embodiments of the present technology.

[0017] Figure 8 is a flow diagram of a process for collecting plasma in accordance with embodiments of the present technology.

[0018] Figure 9 is a flow diagram of a process for collecting plasma in accordance w ith embodiments of the present technology.DETAILED DESCRIPTION

[0019] The present technology' is directed generally to bodily fluid collection tube devices for use with a centrifuge, such as blood collection tubes containing blood from a subject, and associated methods and systems. A collection tube configured in accordance with the present130624.8021. WOOOU83634499.1 Atorney Docket No.: 130624.8021. WOOO technology includes a tube section and a cap section. The tube section is configured to receive bodily fluid, such as whole blood, and a volume of a gel. The cap section is configured to be removably coupled to the tube section (e.g., through the mating of fastener threads on an outer surface of the tube section to an inner surface of a lip of the cap section). When the cap section is coupled to the tube section containing whole blood and the gel, the collection tube is centrifuged such that the cap section is directed downward and the tube section is directed upward in the centrifuge. After centrifugation, the whole blood is separated into a volume of plasma / serum contained in the tube section, and volumes of red blood cells (RBCs) and gel contained in a cavity of the cap section. The cap section is discarded, and the tube section containing the plasma / serum is retained for further processing / analysis.

[0020] Alternatively, the collection tube is centrifuged such that the cap section is directed upward and the tube section is directed downward in the centrifuge. After centrifugation, the collection tube is inverted (e.g.. turned up-side down such that the cap section is downwardfacing and the tube section is upward-facing), resulting in a volume of plasma / serum entering the cavity of the cap section while volumes of gel and RBCs are retained in the tube section. The tube section is discarded, and the cap section containing the plasma / serum is retained for further processing / analy sis .

[0021] In some embodiments, the tube section includes a shelf and / or pocket on an interior surface extending inward (relative to a longitudinal axis of the tube section), and the cap section includes a surface configured to mate with the corresponding shelf and / or pocket of the tube section. In some embodiments, the cap section includes a liner and / or sheath configured to extend from the cap section to a volume of gel contained in the tube section pre-centrifugation. In some embodiments, a non-reactive (with regard to RBCs) lubricant is applied to the interior surfaces of the cap section and the tube section that are in contact with one another. In some embodiments, the tube section includes a cylindrical base and a conical / tapered portion. In some embodiments, the tube section includes one or more pre-designed failure points configured to allow separation of the tube section into multiple subsections (e.g., through force exerted by a user and / or through use of a tool). In further embodiments, the tube section includes a structural support element configured to provide structural support to the pre-designed failure points until removed.

[0022] Specific details of several embodiments of the present technology7are described herein with reference to Figures 1A-9. However, the present technology may be practiced130624.8021. WOOOU83634499.1 Atorney Docket No.: 130624.8021. WOOO without some of these specific details. The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the disclosure. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section.

[0023] The accompanying Figures depict embodiments of the present technology' and are not intended to be limiting of its scope. The sizes of various depicted elements are not necessarily drawn to scale, and these various elements may be arbitrarily enlarged to improve legibility'. Component details may7be abstracted in the Figures to exclude details such as position of components and certain precise connections between such components when such details are unnecessary for a complete understanding of how to make and use the present technology. Many of the details, dimensions, angles, and other features shown in the Figures are merely illustrative of particular embodiments of the disclosure. Accordingly, other embodiments can have other details, dimensions, angles, and features without departing from the spirit or scope of the present technology.

[0024] The headings provided herein are for convenience only and should not be construed as limiting the subject matter disclosed.A. Select Embodiments of Bodily Fluid Collection Devices

[0025] Figure 1A is a perspective view of a bodily fluid collection device 100 (“device 100”) configured in accordance with embodiments of the present technology. The device 100 can be handheld with a size that is easily grasped and manipulated by one or both of a patient’s hands. Such handheld devices advantageously allow a patient to collect a bodily fluid sample (e.g.. a blood sample) without assistance from another individual. In some embodiments, the handheld devices of the present technology can be operated by a layperson outside of a medical setting (e.g., at home or in a field clinic) and without the aid of a medical professional.

[0026] In the illustrated embodiment, the device 100 includes a housing 102 and an actuator 104. The actuator 104 (e.g., a button) can be movable relative to the housing 102 to actuate / initiate withdrawal of a bodily fluid (e.g.. blood) from the patient. The housing 102 is removably coupled to a collection tube 106 (e.g., a reservoir, a collection device, a transfer device, a cartridge, and / or the like) for receiving the bodily fluid withdrawn from the patient. The collection tube 106 can act as a removable and standardized container for bodily fluid that130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO can be detached and used in clinical and laboratory equipment or workflows (e.g., for diagnostics and / or biomarker detection).

[0027] Figure IB is a perspective view of the bodily fluid collection device 100 of Figure 1A in use by the patient in accordance with embodiments of the present technology. To collect a bodily fluid sample, the device 100 is applied to a patient’s body, with a bottom surface of the housing 102 positioned against the skin 101 of the patient and the actuator 104 positioned away from the skin 101. Actuating (e.g., pressing, twisting, pulling) the actuator 104 deploys a skinpiercing feature (e.g., a blade, lancet) from within the device 100 to pierce the skin 101. Subsequent retraction of the actuator 104 away from the skin generates a vacuum within the device 100 that acts against the patient’s skin either directly or indirectly, and before and / or after deployment of the skin-piercing feature. Bodily fluid from the resulting incision is withdrawn into the housing 102 and collected into the collection reservoir 106.

[0028] Figure 1C is a perspective view illustrating detachment of the collection tube 106 from the bodily fluid collection device 100 of Figures 1A and IB in accordance with embodiments of the present technology'. Once a desired amount of bodily fluid has been collected into the collection tube 106, the device 100 is removed from the skin 101, and the collection tube 106 is detached from the housing 102. In some embodiments, the device 100 can include one or more features that are generally similar to or identical to the bodily fluid collection devices disclosed in (i) U.S. Patent No. 10,779.757, filed August 3. 2015; (ii) U.S. Patent No. 11,523,805, filed September 21, 2017, (iii) International Patent Application Publication No. WO 2021 / 076846, filed October 16, 2020, (iv) U.S. Patent No. 11,510,659, filed February' 26, 2021, and / or U.S. Patent No. 11,633,136, filed February 25, 2022, each of which is incorporated herein by reference in its entirety.B. Select Embodiments for Processing Bodily Fluid Collection Tube Devices

[0029] As noted above, high quality blood samples are necessary' for various blood tests, such as CBC tests, also known as full blood count (FBC) tests. Typically, blood for such tests is withdrawn from a patient by collecting blood directly from a vein of the patient (e g., via a venipuncture). It can be challenging, however, to preserve the quality of blood to enable such tests when using handheld collection and processing devices that are operated by a layperson outside of a medical setting (e.g., at home or in a field clinic) and without the aid of a medical professional. For example, many blood tests require centrifugation of whole blood to separate plasma / serum from red blood cells (RBCs). Typically, whole blood is added to a collection tube130624.8021. WOOOU83634499.1 Atorney Docket No.: 130624.8021. WOOO containing a gel used to from a physical barrier between plasma / serum and RBCs. Following centrifugation, the whole blood is separated into a top layer of plasma / serum, a middle barrier layer of gel, and a bottom layer of RBCs. The plasma / serum is used for subsequent testing / processing / analysis, and the RBCs and gel are discarded. However, ensuring that a sufficient volume of high-quality plasma / serum is transferred and / or obtained without contamination from RBCs and gel can be challenging without the aid of trained medical personnel.

[0030] To overcome this and other challenges, the present technology provides a variety of collection tube devices, systems, and methods configured to maximize the amount of plasma / serum recovered while mitigating the potential for RBCs and gel to contaminate the sample. Moreover, embodiments of the present technology7are expected to simplify parts of the blood collection and analysis process to be more easily accessible to laypeople and medical professionals alike.

[0031] Figure 2A. for example, is a cross-sectional side view of a collection tube 200 configured in accordance with embodiments of the present technology. Figure 2B is a cross- sectional side view of the collection tube 200 of Figure 2A after centrifugation in accordance with embodiments of the present technology. In some embodiments, the collection tube 200 can include a number of features generally similar to / identical to the features of the collection tube 106 described with reference to Figures 1A-1C.

[0032] Referring to Figures 2 A and 2B together, the collection tube 200 includes a cap section 210 and a tube section 220. The cap section 210 is configured to be releasably coupled / secured (e.g., via push-on mechanisms, snap-on mechanisms, and the like) to the tube section 220 (as shown in Figure 2A). As shown in Figure 2B, the cap section 210 is also configured to be easily removed (without the use of tools or other devices) from the tube section 220 during processing / operation.

[0033] The cap section 210 includes a first portion 212 (e.g.. a lip, a skirt, etc.) and a second portion 214. As best seen in Figure 2A, when the cap section 210 is engaged with the tube section 220, the first portion 212 is external to the tube section 220 and positioned for engagement by a user or another external component for processing, while the second portion 214 is configured to be positioned at least partially within the tube section 220 and engaged with (e.g.. in direct contact with) an interior surface 225 at a first end portion 222 of the tube section 220. The cap section 210 includes a cavity 211 (represented by a dashed line in the cap section130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO210) configured to receive a volume of bodily fluid (e.g., red blood cells (RBCs) 234) and / or a volume of gel 230. The cavity 211 is defined by the second portion 214 of the cap section 210 such that an opening of the cavity 211 is directed toward the tube section 220 when the cap section 210 is coupled to the tube section 220.

[0034] The tube section 220 includes a second end portion 227 (e.g., a bottom end) opposite the first end portion 222. An inner surface 221 (represented by a dashed line in the tube section 220) of the tube section 220 spans the length of the interior of the tube section 220 (e.g., from the interior surface 225 of the first end portion 222 to an inner portion 228 of the second end portion 227). The inner surface 221 defines a lumen 240 configured to receive the volume of gel 230 and a volume of whole blood 236 pre-centrifugation. The second end portion 227 also includes an outer portion 226 and the inner portion 228. In some embodiments, the outer portion 226 is configured to have a cylindrical shape with a flat bottom 229. The flat bottom 229 is configured to allow the collection tube 200 to stand upright with the flat bottom 229 acting as a base for the collection tube 200. In some embodiments, the inner portion 228 comprises a rounded and / or conical shape configured to taper away from the first end portion 222. In other embodiments, the inner portion 228 can have a different shape and / or configuration.

[0035] In the illustrated embodiment, the gel 230 is a density gradient medium used to act as a physical barrier between a volume of plasma 232 (also referred to as serum and / or plasma / serum) and the volume of RBCs 234 after centrifugation of the collection tube 200. The volume of plasma 232 and the volume of RBCs 234 are derived from a volume of whole blood 236, which is provided to the collection tube 200 pre-centrifugation.

[0036] As discussed further below- with reference to Figure 8, a volume of gel 230 is added to the tube section 220 of the collection tube 200. The collection tube 200 is then used to collect whole blood 236 from a subject (e.g., via the bodily fluid collection device 100 of Figures 1A- 1C). The cap section 210 is coupled to the tube section 220 (e.g.. via the first portion 212 coupling to / mating with the exterior surface 223 of the first end portion 222 of the tube section 220). The collection tube 200 is inverted so that the cap section 210 is directed downward and the tube section 220 is directed upward (i.e.. with reference to the ground / support surface of the local environment). The inverted collection tube 200 is then centrifuged in this inverted orientation. During centrifugation, the whole blood 236 is separated into RBCs 234 and plasma 232. Based on the orientation of the collection tube 200, the RBCs 234 and gel 230 migrate to the cavity 211 of the cap section 210.130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO

[0037] After centrifugation, the collection tube 200 is removed from the centrifuge and re-oriented such that the cap section 210 is directed upward and the tube section 220 is directed downward (i.e., again, with reference to the ground / support surface in the local environment). Due to adherence of the gel 230 to the walls of the cavity 211, the gel 230 and the RBCs 234 are retained in the cavity 211. At the same time, plasma 232 collects in the tube section 220. The cap section 210 containing the RBCs 234 and gel 232 may then be discarded, and the tube section 220 containing the plasma 232 is retained for further processing / analysis.

[0038] Figure 3A is a cross-sectional side view of a collection tube 300 configured in accordance with further embodiments of the present technology. Figure 3B is a cross-sectional side view of the collection tube 300 of Figure 3A after centrifugation in accordance with embodiments of the present technology. In some embodiments, collection tube 300 can include a number of features generally similar to / identical to the features of the collection tube 200 described with reference to Figures 2A and 2B. Accordingly, like reference numbers refer to like components.

[0039] Referring to Figures 3A and 3B together, in the illustrated embodiment, the collection tube 300 is comprised of a cap section 310 and a tube section 320. In some embodiments, the tube section 320 is configured to receive a volume of gel 330 and a volume of whole blood 336 pre-centrifugation. During centrifugation of the collection tube 300, the whole blood 336 separates into a volume of RBCs 334 and plasma / serum 332 (Figure 3B). The cap section 310 includes a cavity 311 configured to receive a volume of plasma / serum 332 during and post-centrifugation of the collection tube 300. Put another way, one of the distinguishing features of the collection tube 300 as compared to the collection tube 200 of Figures 2A and 2B is that post-centrifugation of collection tube 300. the plasma / serum 332 is received by the cap section 310 and the RBCs 334 and gel 330 are received by the tube section 320. Conversely, post-centrifugation of collection tube 200 (Figures 2A and 2B), the plasma / serum 232 is received by the tube section 220 and the RBCs 234 and gel 230 are received by the cap section 210.

[0040] In some embodiments, the cap section 310 of collection tube 300 includes a flat outer surface 315 configured to act as a base for the cap section 310 so that an opening of the cavity 311 is directed upward (i.e., relative to the ground / support surface in the local environment) when the flat outer surface 315 is placed on the corresponding surface (e g., a table, a lab bench, etc.).130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO

[0041] As discussed further below with reference to Figure 9, a volume of gel 330 is added to the tube section 320 of the collection tube 300. The collection tube 300 is then used to collect whole blood 336 from a subject (e.g., via the bodily fluid collection device 100 of Figures 1 A- 1 C). The cap section 310 is coupled to the tube section 320 (e.g., via a first portion 312 coupling to / mating with an exterior surface 323 of a first end portion 322 of the tube section 320). The collection tube 300 is centrifuged with the cap section 310 directed upward and the tube section 320 directed downward (i.e., with reference to the ground / support surface in the local environment). During centrifugation, the whole blood 336 is separated into RBCs 334 and plasma 332 (Figure 3B). Based on the orientation of the collection tube 300, the plasma 332, RBCs 334 and gel 330 accumulate in the tube section 320. After centrifugation, the collection tube 300 is removed from the centrifuge (while remaining inverted) such that the cap section 310 is directed downward and the tube section 320 is directed upward (as shown in Figure 3B). This causes the plasma 332 to flow from the tube section 320 to the cavity 311 of the cap section 310. Due to adherence of the gel 330 to an inner surface 321 of the tube section 320, the gel 330 and the RBCs 334 are retained in the tube section 320. The tube section 320 containing the RBCs 334 and gel 330 may be discarded, and the cap section 310 containing the plasma 332 is retained for further processing / analysis.

[0042] Figures 4A and 4B are partial cross-sectional side views of a collection tube 400 configured in accordance with further embodiments of the present technology. More specifically , Figure 4A illustrates a tube section 420 and cap section 410 of the collection tube 400 separated from each other, and Figure 4B shows the tube section 420 and cap section 410 mated to each other. In some embodiments, the collection tube 400 can include a number of features generally similar to / identical to the features of the collection tube 200 described with reference to Figures 2A and 2B and / or collection tube 300 described with reference to Figures 3A and 3B. Accordingly, like reference numbers refer to like components.

[0043] Referring to Figures 4A and 4B together, in the illustrated embodiment, the cap section 410 includes a first portion 412 and a second portion 414 configured to contact / engage an interior surface 425 of the tube section 420 when the cap section 410 is coupled with the tube section 420. The tube section 420 includes a first end portion 422 and a second end portion (not pictured) opposite the first end portion 422. The first end portion 422 includes a narrow portion 450 having a radius R1 and a wide portion 452 having a radius R2 greater than R1. Radii R1 and R2 are measured from a longitudinal center line CL (e.g., a longitudinal axis) of the collection130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO tube 400 to an inner surface of the collection tube (e.g., interior surface 425, an inner surface 421, etc.).

[0044] The narrow portion 450 and wide portion 452 of the tube section 420 are positioned such that a shelf 454 (e.g., a ledge, mantle, extension, etc.) extending inward with respect to the center line CL of the collection tube 400 is defined at or approximately at the interface between the narrow portion 450 and the wide portion 452. As best seen in Figure 4B, when the cap section 410 is coupled to the tube section 420, the shelf 454 is sized and shaped to contact a portion of the cap section 410 (e.g., the second portion 414) such that at least a part of the interface where the shelf 454 meets the cap section 410 is perpendicular to or approximately perpendicular to the center line CL of the collection tube 400.

[0045] As best seen in Figure 4B, in some embodiments, an interior wall 416 of the second portion 414 of the cap section 410 is configured to form a continuous or near-continuous surface (e.g., flush surface) with the surface of the narrow portion 450 (e.g.. the part of the inner surface 421 comprising the narrow portion 450) when the cap section 410 is coupled with the tube section 420. In some embodiments, a radius R3 of a cavity 411 of the cap section 410 is approximately equal to the radius R1 of the narrow portion 450. By forming a flush / generally continuous surface between the second portion 414 and the narrow portion 450, RBCs and / or gel (not pictured) are less likely to enter the interface area between the cap section 410 and the shelf 454, thereby reducing the potential for contamination of the plasma (not pictured) and increasing sample yield.

[0046] In some embodiments, a volume of lubricant (e.g., a viscous substance) configured to prevent RBCs from entering the interface area between the cap section 410 and the shelf 454 is applied to one or more surfaces of the cap section 410 and / or tube section 420. For example, the lubricant can be applied to the interface between the cap section 410 and the shelf 454, at least a portion of the interior wall 416 of the second portion 414 of the cap section 410, at least a portion of the inner surface 421 of the tube section 420, and the like.

[0047] Figures 4C and 4D are partial cross-sectional side views of a collection tube 401 configured in accordance with another embodiment of the present technology7. In particular, Figure 4C shows the tube section 420a and cap section 410a separated from each other. Figure 4D shows the tube section 420a and cap section 410a mated to each other. In some embodiments, collection tube 401 can include a number of features generally similar to / identical to the features of the collection tube 200 described with reference to Figures 2A and 2B and / or130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO collection tube 300 described with reference to Figures 3A and 3B. Accordingly, like reference numbers refer to like components.

[0048] Referring to Figures 4C and 4D together, in the illustrated embodiment, the narrow portion 450a and wide portion 452a are configured such that a projection 456a (e.g., a protrusion) extends toward the first end portion 422a and away from the second end portion (not pictured) of the tube section 420a. The projection 456a is configured to contact a corresponding portion of the cap section 410a (e.g., the second portion 414a). The projection 456a and corresponding portion of the cap section 410a are configured to fit together (e.g., each of the second portion 414a and projection 456a can be shaped to accommodate each other) such that at least part of the interface between the projection 456a and cap section 410a forms approximately an acute angle A2 relative to the center line CL of the collection tube 401 when the cap section 410a is coupled to the tube section 420a.

[0049] Figure 5 is a cross-sectional side view of a collection tube 500 configured in accordance with an embodiment of the present technology. The collection tube 500 can include a number of features generally similar to / identical to the features of any of the collection tubes described throughout the present application (e.g., collection tube 200 with reference to Figures 2A and 2B and / or collection tube 300 described with reference to Figures 3A and 3B). Accordingly, like reference numbers refer to like components.

[0050] In the present embodiment, the cap section 510 of collection tube 500 includes a first portion 512 configured to couple the cap section 510 to the tube section 520 via an exterior surface 523 of the tube section 520. The first portion 512 includes fastener threads configured to mate / couple with corresponding fastener threads of the exterior surface 523. When the fastener threads of the first portion 512 and the exterior surface 523 are coupled, a second portion 514 of the cap section 510 is configured to be positioned upon and in contact with an interior surface 525 of the tube section 520.

[0051] In some embodiments, the tube section 520 includes a bottom end 527 comprised of an inner portion 528 and an outer portion 526. The inner portion 528 is conical shaped (e.g., tapered) such that the cone generally narrows in a direction opposite a top end 522 of the tube section 520. The outer portion 526 is a cylindrical shape including a flat surface 529 configured to act as a base upon which the collection tube 500 can stand upright (i.e., when place on a support surface such as a lab bench or table).130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO

[0052] Figure 6 is a cross-sectional side view of a collection tube configured in accordance with another embodiment of the present technology. The collection tube 600 can include a number of features generally similar to / identical to the features of any of the collection tubes described throughout the present application (e.g., collection tube 200 with reference to Figures 2A and 2B and / or collection tube 300 described with reference to Figures 3A and 3B). Accordingly, like reference numbers refer to like components.

[0053] In the present embodiment, the collection tube 600 includes an inner liner 660 (e.g., an inner sheath, layer, etc.) configured to attach / couple to a fixation surface 617 of a cap section 610 of the collection tube 600. In some embodiments, the fixation surface 617 is part of and / or adjacent to a cavity 611 of the cap section 610. The inner liner 660 extends along a at least a portion of the collection tube 600 (e.g., an inner surface 621) such that the interface and / or contact area between a second portion 614 of the cap section 610 and an interior surface 625 of the tube section 620 is covered. This arrangement is expected to inhibit / prevent gel 630. whole blood 636, RBCs (not pictured), and / or plasma (not pictured) from entering and / or becoming trapped in the interface / contact area. In some embodiments, the inner liner 660 is configured to extend at least partially into the gel 630 prior to centrifugation of the collection tube 600.

[0054] Figures 7A and 7B are cross-sectional side views of a collection tube 700 configured in accordance with still another embodiment of the present technology. The collection tube 700 can include a number of features generally similar to / identical to the features of any of the collection tubes described throughout the present application (e.g., collection tube 200 with reference to Figures 2A and 2B and / or collection tube 300 described with reference to Figures 3A and 3B). Accordingly, like reference numbers refer to like components.

[0055] Referring to Figures 7A and 7B together, the collection tube 700 includes one or more pre-designed and pre-positioned failure points 770. The failure points 770 allow for the tube 700 to be broken at and / or along the failure points 770 (when desired) by applying a threshold force thereto. The failure points 770 are configured to allow- a part of a tube section 720 proximate a cap section 710 of the tube 700 to remain coupled to the cap section 710 when discarding one or the other of the cap section 710 or tube section 720 (e.g., post-centrifugation). This arrangement is expected to provide better containment of the bodily fluid and / or gel in the cap section 710, which is then either retained (e g., if the cap section 710 contains plasma) or discarded (e.g., if the cap section 710 contains RBCs and gel). In some embodiments the failure points 770 are configured to be broken via manual rotational force (e.g., threshold force applied130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO using a user’s hands). In other embodiments, the failure points 770 are configured to be broken via a tool (not shown). In some embodiments, the cap section 710 is configured to be locked and / or adhered to the tube section 720, allowing greater sealing of the cap section 710 to the tube section 720 and reducing the likelihood of trapping RBCs in the interface / mating space between the cap section 710 and the tube section 720.

[0056] As best seen in Figure 7B, in some embodiments, the collection tube 700 includes a structural support feature 772 configured to prevent inadvertent / unintentional breakage at failure points 770 until desired. For example, failure points 770 can be shaped as a ring around the circumference of a segment of tube section 720. The structural support feature 772 can be shaped as a ring corresponding to the ring shape of the failure points 770. The structural support feature 772 can be positioned at least partially on and / or in the failure points 770 to prevent unwanted breaking at failure points 770. When it is desired that the failure points 770 be broken, the structural support feature 772 is removed and the failure points 770 are broken.

[0057] Figure 8 is a flow diagram of a process 800 for collecting serum / plasma in accordance with embodiments of the present technology. In some embodiments, serum / plasma is collected using a collection tube that includes a number of features generally similar to / identical to the features of any of the collection tubes described throughout the present application (e.g., collection tube 200 with reference to Figures 2A and 2B).

[0058] At block 802 of process 800, a collection tube comprising a cap section and a tube section is prepared to receive a volume of bodily fluid (e.g.. whole blood) from a subject (e.g., a patient). In some embodiments, preparation of the collection tube includes adding a volume of gel or other density gradient medium to the tube section. At block 804, the bodily fluid is collected in the collection tube (e.g., the tube section). In some embodiments, collection of the bodily fluid occurs via a bodily fluid collection device generally similar to / identical to the bodily fluid collection device 100 described with reference to Figures 1A-1C. At block 806, the cap section is coupled to the tube section (e.g., by coupling / mating a portion of the cap section to a surface of a top end of the tube section). For example, the cap section can include fastener threads configured to couple to corresponding fastener threads of the tube section. Additionally at block 806, after the cap section is coupled to the tube section, the collection tube is inverted (e.g., turned upside-down) such that the cap section is directed downward and the tube section is directed upward with respect to the ground / support surface in the local environment.130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO

[0059] At block 808 the collection tube is centrifuged in the inverted orientation (e.g., cap section directed downward, tube section directed upward). Centrifugation causes the bodily fluid to separate into layers. For example, the volume of whole blood can separate into distinct layers of a volume of plasma and a volume of RBCs. The gel is configured to act as a separating layer (e.g., a barrier) between the plasma layer and the RBC layer. Due to the inverted orientation of the collection tube, centrifugation causes the plasma layer to be positioned in the tube section of the collection tube, and the RBC layer and gel layer in the cap section of the collection tube. In some embodiments the cap section includes a cavity to which the RBCs and gel migrate during centrifugation.

[0060] At block 810, after centrifugation, the collection tube is re-oriented such that the cap section is directed upward and the tube section is directed downward (e g., re-inverted to the collection tube’s original orientation). The gel is configured to adhere to the cap section such that the gel and RBCs remain with the cap section. In some embodiments, the gel is configured to adhere to one or more inner walls of the cavity of the cap section. At the same time, the plasma collects in the tube section. The cap section containing the RBCs and gel is discarded, and the tube section containing the serum / plasma is retained for further processing / analysis.

[0061] Figure 9 is a flow diagram of a process 900 for collecting serum / plasma in accordance with embodiments of the present technology. In some embodiments, plasma is collected using a collection tube that includes a number of features generally similar to / identical to the features of any of the collection tubes described throughout the present application (e.g., collection tube 300 with reference to Figures 3A and 3B).

[0062] At block 902 of process 900, a collection tube comprising a cap section and a tube section is prepared to receive a volume of bodily fluid (e.g., whole blood). In some embodiments, preparation of the collection tube includes adding a volume of gel or other density gradient medium to the tube section. At block 904, the bodily fluid is collected in the collection tube (e.g., the tube section). In some embodiments, collection of the bodily fluid occurs via a bodily fluid collection device generally similar to / identical to the bodily fluid collection device 100 described with reference to Figures 1A-1C. At block 906, the cap section is coupled to the tube section and the collection tube is centrifuged such that the cap section is directed upward and the tube section is directed downward with respect to the ground / support surface in the local environment.130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO

[0063] At block 908, after centrifugation, the collection tube is inverted such that the cap section is directed downward and the tube section is directed upward. This orientation causes a volume of plasma derived from the whole blood to migrate / move to the cap section. In some embodiments, the cap section includes a cavity configured to receive the plasma. Due to adherence of the gel to an inner surface of the tube section, the gel and a volume of RBCs remain in the tube section while the collection tube is inverted. At block 910, the tube section containing the RBCs and gel is discarded, and the cap section containing the serum / plasma is retained for further processing / analysis.C. Examples

[0064] The present technology is illustrated, for example, according to various aspects described below. Various examples of aspects of the present technology are described as numbered examples (1, 2, 3. etc.) for convenience. These are provided as examples and do not limit the present technology. It is noted that any of the dependent examples can be combined in any suitable manner, and placed into a respective independent example. The other examples can be presented in a similar manner.1. A bodily fluid collection tube for use with a centrifuge, the collection tube comprising: a tube section including a first end portion and a second end portion opposite the first end, wherein the tube section defines a lumen extending at least partially between the first and second end portions; wherein the lumen is configured to receive a volume of whole blood and a volume of a gel; and a cap section including: a first portion; and a second portion configured to be positioned in contact with an interior surface of the first end portion of the tube section when the cap section is engaged with the tube section; wherein the second portion of the cap section defines a cavity, and wherein, after centrifuging the collection tube, the cavity is configured to receive a volume of red blood cells and a volume of the gel, the volume of red blood cells being derived from the volume of whole blood.130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO2. The collection tube of example 1 wherein the first end portion of the tube section further includes a shelf surface adjacent to the interior surface, the shelf surface extending radially inward toward a longitudinal axis of the tube section, and wherein the second portion of the cap section is further configured to contact the shelf surface when the cap section is coupled to the tube section.3. The collection tube of example 2 wherein the shelf surface includes a protrusion extending away from the second end toward the first end portion of the tube section, and wherein the second portion of the cap section is further configured to contact the protrusion when the cap section is coupled to the tube section.4. The collection tube of example 2 or example 3 wherein the cap section in contact with the shelf surface and the shelf surface are further configured to receive a volume of lubricant that is non-reactive with the volume of red blood cells.5. The collection tube of any of examples 1-4 wherein the cap section further includes an inner liner, the inner liner configured to be positioned over substantially all of the inner surface of the tube section and substantially all of the second portion of the cap section when the cap section is coupled with the tube section.6. The collection tube of any of examples 1-5 wherein the cavity7defined by the second portion of the cap section is further configured to receive a volume of plasma derived from the volume of whole blood, and the lumen of the inner surface is further configured to receive the volume of red blood cells and the volume of the gel after use with the centrifuge.7. The collection tube of any of examples 1-6 wherein the tube section further includes a weakened structural area designed to preferentially break when a threshold force is applied.8. The collection tube of example 7 wherein the weakened structural area is supported by a structural support element configured to be removed prior to applying the threshold force.130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO9. A bodily fluid collection tube for use with a centrifuge, the collection tube comprising: a tube including: a rim portion defining an opening of the tube; and an end portion opposite the rim portion; wherein the tube defines a lumen extending at least partially between the end portion and the rim portion, and wherein the lumen is configured to receive a volume of whole blood and a volume of a gel; and a cap including a collection cavity, wherein the collection cavity' is configured to contact an interior surface of the rim portion such that at least an approximate fluid-tight seal is formed over the opening of the tube when the cap is engaged with the tube; wherein, after centrifuging the collection tube, the collection cavity is configured to receive a volume of red blood cells and at least a portion of the volume of the gel, the volume of red blood cells being derived from the volume of whole blood.10. The collection tube of example 9 wherein the tube further includes a shelf section extending radially inward toward a longitudinal axis of the tube, and wherein the collection cavity of the cap is further configured to contact the shelf section when the cap is engaged with the tube. f 1. The collection tube of example f 0 wherein the shelf section includes a lip portion extending away from the end portion toward the opening of the tube such that a space is defined between the lip portion and an interior surface of the tube, and wherein the collection cavity of the cap is further configured to fit into the space and to contact the lip portion when the cap is engaged with the tube.12. The collection tube of example 10, further comprising a volume of lubricant that is non-reactive with whole blood, wherein the volume of lubricant is applied at least partially over a surface of the collection cavity of the cap and at least partially over a surface of the shelf section of the tube such that the volume of lubricant forms at least an approximate fluid-tight seal between the collection cavity and the shelf section when the cap is engaged with the tube.130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO13. The collection tube of any of examples 9-12 wherein the cap further includes a liner, wherein the liner is configured to extend from the cap and be positioned over substantially all of an interior surface of the tube when the cap is engaged with the tube.14. The collection tube of any of examples 9-13 wherein the collection cavity is further configured to receive a volume of plasma derived from the volume of whole blood, and wherein the lumen of the tube is further configured to receive the volume of red blood cells and the volume of the gel after centrifuging.15. The collection tube of any of examples 9-14 wherein the tube further includes a pre-designed failure area, and wherein the tube is further configured to break at least approximately at the pre-designed failure area when a threshold force is applied.16. The collection tube of example 15, further comprising a removable support element positioned at least approximately at the pre-designed failure area, wherein the removable support element is configured to prevent breaking of the tube at the pre-designed failure area when the threshold force is applied.17. A collection tube for use with a centrifuge, the collection tube comprising: a tube including: a rim portion defining an opening of the tube; and an end portion opposite the rim portion, the end portion including: a tapered inner portion; and a cylindrical outer portion disposed at least partially over the tapered inner portion; wherein the tapered inner portion is configured to receive a volume of whole blood and a volume of a gel; and a cap including a collection cavity, wherein the collection cavity is configured to contact an interior surface of the rim portion such that at least an approximate fluid-tight seal is formed over the opening of the tube when the cap is engaged with the tube, wherein, after centrifugation, the collection cavity is configured to receive a volume of red blood cells and at least a portion of the volume of the gel. the volume of red blood cells being derived from the volume of whole blood.130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO18. The collection tube of example 17 wherein the tube further includes a shelf section extending radially inward toward a longitudinal axis of the tube, and wherein the collection cavity of the cap is further configured to contact the shelf section when the cap is engaged with the tube.19. The collection tube of example 18 wherein the shelf section includes a lip portion extending away from the end portion toward the opening of the tube such that a space is defined between the lip portion and an interior surface of the tube, and wherein the collection cavity of the cap is further configured to fit into the space and to contact the lip portion when the cap is engaged with the tube.20. The collection tube of example 17, further comprising a volume of lubricant that is non-reactive with whole blood, wherein the volume of lubricant is applied at least partially over a surface of the collection cavity of the cap and at least partially over a surface of the shelf section of the tube such that the volume of lubricant forms at least an approximate fluid-tight seal between the collection cavity and the shelf section when the cap is engaged with the tube.21. A bodily fluid collection system, comprising: a collection tube including: a tube section including: a first portion defining an opening of the tube section; a second portion opposite the first portion; and a volume of a gel contained at least partially within the second portion; wherein the tube section defines a lumen extending at least partially between the first and second portions, and wherein the lumen is configured to receive a volume of whole blood via the opening of the first portion: and a cap section including: an outer portion configured to contact an outer surface of the first portion of the tube section when the tube section is engaged with the cap section; and130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO an inner portion defining a cavity, wherein the inner portion is configured to contact an inner surface of the first portion of the tube section when the tube section is engaged with the cap section, and wherein, after centrifuging the collection tube, the cavity of the inner portion of the cap section is configured to receive a volume of red blood cells derived from the volume of whole blood and at least a portion of the volume of the gel.22. The system of example 21 wherein the cavity of the inner portion of the cap section is further configured to receive a volume of plasma derived from the volume of whole blood, and wherein the lumen of the tube section is further configured to receive the volume of red blood cells and the volume of the gel after centrifuging with the centrifuge.23. The system of example 21 or example 22 wherein the tube section further includes a pre-designed failure area, and wherein the tube section is further configured to break at least approximately at the pre-designed failure area when a threshold force is applied.24. The system of example 23, further comprising a removable support element positioned at least approximately at the pre-designed failure area, and wherein, when the threshold force is applied, the removable support element is configured to prevent breakage of the tube section at the pre-designed failure area.25. The system of any of examples 21-24 wherein: the tube section further includes a shelf section extending radially inward toward a longitudinal axis of the tube section; and the cavity7of the inner portion of the cap section is further configured to contact the shelf section when the cap section is engaged with the tube.26. The system of example 25 wherein: the shelf section includes a lip extending toward the opening of the tube section such that a space is defined between the lip portion and an interior surface of the tube section, and130624.8021. WOOOU83634499.1 Atorney Docket No.: 130624.8021. WOOO when the cap section is engaged with the tube section, the cavity of the inner portion of the cap section is sized and shaped to fit into the space and to contact the lip portion.27. The system of any of examples 21-26, further comprising a volume of lubricant that is non-reactive with whole blood, wherein the volume of lubricant is applied at least partially over a surface of the cavity of the inner portion of the cap section and at least partially over a surface of the shelf section of the tube section such that the volume of lubricant forms at least an approximate fluid-tight seal between the cavity and the shelf section when the cap section is engaged with the tube section.28. The system of any of examples 21-27, further comprising a liner within at least a portion of the cap section, and wherein, when the cap section is engaged with the tube section, the liner is sized and shaped to extend from the cap section and be positioned over substantially all of an interior surface of the tube section.D. Conclusion

[0065] The above detailed description of embodiments of the present technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, although steps may be presented in a given order, in other embodiments, the steps may be performed in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0066] All numeric values are herein assumed to be modified by the term about whether or not explicitly indicated. The term about, in the context of numeric values, generally refers to a range of numbers that one of skill in the art w ould consider equivalent to the recited value (e.g., having the same function and / or result). For example, the term about can refer to the stated value plus or minus ten percent. For example, the use of the term about 100 can refer to a range of from 90 to 110, inclusive. In instances in which the context requires otherwise and / or relative terminology is used in reference to something that does not include, or is not related to, a numerical value, the terms are given their ordinary meaning to one skilled in the art.130624.8021. WOOOU83634499.1 Atorney Docket No.: 130624.8021. WOOO

[0067] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0068] As used herein, the phrase and / or as in A and / or B refers to A alone, B alone, and A and B. Additionally, the term comprising is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional t pes of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology7can encompass other embodiments not expressly shown or described herein.

Claims

130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOOCLAIMSI / 'W e claim:

1. A bodily fluid collection tube for use with a centrifuge, the collection tube comprising: a tube including: a rim portion defining an opening of the tube; and an end portion opposite the rim portion; wherein the tube defines a lumen extending at least partially between the end portion and the rim portion, and wherein the lumen is configured to receive a volume of whole blood and a volume of a gel; and a cap including a collection cavity, wherein the collection cavity is configured to contact an interior surface of the rim portion such that at least an approximate fluid-tight seal is formed over the opening of the tube when the cap is engaged with the tube; wherein, after centrifuging the collection tube, the collection cavity is configured to receive a volume of red blood cells and at least a portion of the volume of the gel, the volume of red blood cells being derived from the volume of whole blood.

2. The collection tube of claim 1 wherein the tube further includes a shelf section extending radially inward toward a longitudinal axis of the tube, and wherein the collection cavity of the cap is further configured to contact the shelf section when the cap is engaged with the tube.

3. The collection tube of claim 2 wherein the shelf section includes a lip portion extending away from the end portion toward the opening of the tube such that a space is defined between the lip portion and an interior surface of the tube, and w herein the collection cavity’ of the cap is further configured to fit into the space and to contact the lip portion when the cap is engaged with the tube.

4. The collection tube of claim 2, further comprising a volume of lubricant that is non-reactive w ith whole blood, wherein the volume of lubricant is applied at least partially over a surface of the collection cavity of the cap and at least partially over a surface of the shelf section130624.8021. WOOOU83634499.1 Atorney Docket No.: 130624.8021. WOOO of the tube such that the volume of lubricant forms at least an approximate fluid-tight seal between the collection cavity’ and the shelf section when the cap is engaged with the tube.

5. The collection tube of claim 1 wherein the cap further includes a liner, wherein the liner is configured to extend from the cap and be positioned over substantially all of an interior surface of the tube when the cap is engaged with the tube.

6. The collection tube of claim 1 wherein the collection cavity is further configured to receive a volume of plasma derived from the volume of whole blood, and wherein the lumen of the tube is further configured to receive the volume of red blood cells and the volume of the gel after centrifuging.

7. The collection tube of claim 1 wherein the tube further includes a pre-designed failure area, and wherein the tube is further configured to break at least approximately at the predesigned failure area when a threshold force is applied.

8. The collection tube of claim 7, further comprising a removable support element positioned at least approximately at the pre-designed failure area, wherein the removable support element is configured to prevent breaking of the tube at the pre-designed failure area when the threshold force is applied.

9. A collection tube for use with a centrifuge, the collection tube comprising: a tube including: a rim portion defining an opening of the tube; and an end portion opposite the rim portion, the end portion including: a tapered inner portion; and a cylindrical outer portion disposed at least partially over the tapered inner portion; wherein the tapered inner portion is configured to receive a volume of whole blood and a volume of a gel; and a cap including a collection cavity, wherein the collection cavity is configured to contact an interior surface of the rim portion such that at least an approximate fluid-tight seal is formed over the opening of the tube when the cap is engaged with the tube,130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO wherein, after centrifugation, the collection cavity is configured to receive a volume of red blood cells and at least a portion of the volume of the gel. the volume of red blood cells being derived from the volume of whole blood.

10. The collection tube of claim 9 wherein the tube further includes a shelf section extending radially inward toward a longitudinal axis of the tube, and wherein the collection cavity of the cap is further configured to contact the shelf section when the cap is engaged with the tube.

11. The collection tube of claim 10 wherein the shelf section includes a lip portion extending away from the end portion toward the opening of the tube such that a space is defined between the lip portion and an interior surface of the tube, and wherein the collection cavity' of the cap is further configured to fit into the space and to contact the lip portion when the cap is engaged with the tube.

12. The collection tube of claim 10, further comprising a volume of lubricant that is non-reactive with whole blood, wherein the volume of lubricant is applied at least partially over a surface of the collection cavity of the cap and at least partially over a surface of the shelf section of the tube such that the volume of lubricant forms at least an approximate fluid-tight seal between the collection cavity and the shelf section when the cap is engaged with the tube.

13. A bodily fluid collection system, comprising: a collection tube including: a tube section including: a first portion defining an opening of the tube section; a second portion opposite the first portion; and a volume of a gel contained at least partially within the second portion; wherein the tube section defines a lumen extending at least partially between the first and second portions, and wherein the lumen is configured to receive a volume of whole blood via the opening of the first portion: and a cap section including:130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO an outer portion configured to contact an outer surface of the first portion of the tube section when the tube section is engaged with the cap section; and an inner portion defining a cavity, wherein the inner portion is configured to contact an inner surface of the first portion of the tube section when the tube section is engaged with the cap section; wherein, after centrifuging the collection tube, the cavity of the inner portion of the cap section is configured to receive a volume of red blood cells derived from the volume of whole blood and at least a portion of the volume of the gel.

14. The system of claim 13 wherein the cavity of the inner portion of the cap section is further configured to receive a volume of plasma derived from the volume of whole blood, and wherein the lumen of the tube section is further configured to receive the volume of red blood cells and the volume of the gel after centrifuging with the centrifuge.

15. The system of claim 13 wherein the tube section further includes a pre-designed failure area, and wherein the tube section is further configured to break at least approximately at the pre-designed failure area when a threshold force is applied.

16. The system of claim 15, further comprising a removable support element positioned at least approximately at the pre-designed failure area, and wherein, when the threshold force is applied, the removable support element is configured to prevent breakage of the tube section at the pre-designed failure area.

17. The system of claim 13 wherein: the tube section further includes a shelf section extending radially inward toward a longitudinal axis of the tube section; and the cavity of the inner portion of the cap section is further configured to contact the shelf section when the cap section is engaged with the tube.130624.8021. WOOO\183634499.1 Atorney Docket No.: 130624.8021. WOOO18. The system of claim 17 wherein: the shelf section includes a lip portion extending toward the opening of the tube section such that a space is defined between the lip portion and an interior surface of the tube section, and when the cap section is engaged with the tube section, the cavity of the inner portion of the cap section is sized and shaped to fit into the space and to contact the lip portion.

19. The system of claim 17, further comprising a volume of lubricant that is non- reactive with whole blood, wherein the volume of lubricant is applied at least partially over a surface of the cavity of the inner portion of the cap section and at least partially over a surface of the shelf section of the tube section such that the volume of lubricant forms at least an approximate fluid-tight seal between the cavity and the shelf section when the cap section is engaged with the tube section.

20. The system of claim 13, further comprising a liner within at least a portion of the cap section, and wherein, when the cap section is engaged with the tube section, the liner is sized and shaped to extend from the cap section and be positioned over substantially all of an interior surface of the tube section.

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