Automatic additive mixing blood collection tube

Abstract

A sample collection assembly, including a container having a first end with an opening therein, a second end, and an interior cavity; a stopper sealing the opening, wherein the stopper comprises a chamber and wherein the chamber is configured to receive the sample from a needle piercing the stopper; a substrate enclosing the chamber and permeable to the sample, the substrate containing an additive; and an agitator coupled to the stopper, wherein the agitator is configured to modify a fluid flow characteristic of the sample permeating through the substrate.

Description

Atorney Docket No. 03896-2505739P-29893.WOOlAUTOMATIC ADDITIVE MIXING BLOOD COLLECTION TUBECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Patent No. 63 / 713,202 entitled “Automatic Additive Mixing Blood Collection Tube” filed October 29, 2024, the disclosure of which is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] The present disclosure is directed to biological sample collection, and, more particularly, towards to collection tubes and components and methods of use thereof for exposure and mixing additives to collected samples.BACKGROUND OF THE INVENTION

[0003] Biological fluid samples, such as blood, plasma, or the like, are routinely collected in evacuated collection tubes. Such tubes may be constructed of glass or plastic with desired liquid and gas impermeability features. The fluid drawn into a tube is typically mixed with an additive present in the tube prior to collection of the fluid sample. Such additives may include one or more clot activators, anticoagulants, or other substance or compound desired to treat the collected sample. The additive, whether a procoagulant for clot activation, an anticoagulant for clotting inhibition, or otherwise must be rapidly and thoroughly mixed with the blood sample to achieve its end use functionality. Further, additives present in the tube typically require precise concentrations to obtain reliable tube-to-tube performance.

[0004] In addition, conventional evacuated tubes require manual inversion of tube to mix additives and stabilize the collected blood sample. However, this mixing step may be performed incorrectly, which can result in sample quality issues such as erroneous results and re-test requirements. Mixing may also be especially challenging for low volume collection (LVC) tubes due to large headspace or small diameter capillary tube design.

[0005] The present disclosure provides systems, devices, and methods of use thereof that improve additive exposure to, and mixing with, a collected biological fluid sample.Page 1 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOlSUMMARY OF THE INVENTION

[0006] In accordance with one aspect, the present disclosure provides a sample collection assembly, comprising: a container having a first end with an opening therein, a second end, and an interior cavity; a stopper sealing the opening, wherein the stopper comprises a chamber and wherein the chamber is configured to receive the sample from a needle piercing the stopper; a substrate enclosing the chamber and permeable to the sample, the substrate containing an additive; and an agitator coupled to the stopper, wherein the agitator is configured to modify a fluid flow characteristic of the sample permeating through the substrate.

[0007] In some non-limiting embodiments or aspects, the substrate may be axially spaced from a proximal wall of the cavity.

[0008] In some non-limiting embodiments or aspects, the substrate may be a porous foam.

[0009] In some non-limiting embodiments or aspects, the additive may include at least one of an anticoagulant or a coagulant.

[0010] In some non-limiting embodiments or aspects, the agitator may define a converging fluid flow path.

[0011] In some non-limiting embodiments or aspects, the agitator may define a diverging fluid flow path.

[0012] In some non-limiting embodiments or aspects, the agitator may define a first portion with a converging fluid flow path and a second portion with a diverging fluid flow path.

[0013] In some non-limiting embodiments or aspects, the first portion may be proximal of the second portion.

[0014] In some non-limiting embodiments or aspects, the agitator may include a plug configured to slow a flow rate through the fluid flow path.

[0015] In some non-limiting embodiments or aspects, the plug may be constructed from a porous material.

[0016] In some non-limiting embodiments or aspects, the agitator may be axially spaced from the substrate.

[0017] In some non-limiting embodiments or aspects, the container may be an evacuated tube.

[0018] In accordance with one aspect, the present disclosure provides a sample collection assembly, comprising: an evacuated tube having a first end with an opening therein, a closed second end, and an interior cavity; a stopper sealing the opening, the stopper defining a chamber in fluid communication with the interior cavity; a porous substrate at least partiallyPage 2 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl positioned within the chamber, the substrate containing an additive configured to react with a sample; and an agitator extending distally from the stopper and configured to modify a fluid flow characteristic of the sample exiting the substrate, the agitator defining at least one of a converging fluid flow path or a diverging fluid flow path between the substrate and the interior cavity.

[0019] In accordance with one aspect, the present disclosure provides a connector, comprising: a proximal end defining a first coupling feature; a distal end defining a second coupling feature; a fluid path extending from the proximal end to the distal end; and a substrate at least partially positioned within the fluid path, the substrate containing an additive configured to react with a sample flowing through the fluid path.

[0020] In some non-limiting embodiments or aspects, at least one of the first coupling feature and the second coupling feature may be a luer lock connector.

[0021] In some non-limiting embodiments or aspects, each of the first coupling feature and the second coupling feature may be a luer lock connector.

[0022] In some non-limiting embodiments or aspects, the substrate may be a porous foam.

[0023] In some non-limiting embodiments or aspects, the additive may include at least one of an anticoagulant or a coagulant.

[0024] In accordance with one aspect, the present disclosure provides a sample collection assembly, comprising: the connector disclosed herein and a syringe releasably attachable to the first coupling feature.

[0025] In some non-limiting embodiments or aspects, the sample collection assembly may include a needle hub releasably attached to the second coupling feature.

[0026] In accordance with one aspect, the present disclosure provides a sample collection assembly, comprising: a stopper configured to seal an opening, wherein the stopper comprises a chamber configured to receive the sample from a needle piercing the stopper; a substrate enclosing the chamber and permeable to the sample, the substrate containing an additive; and an agitator coupled to the stopper, wherein the agitator is configured to modify a fluid flow characteristic of the sample permeating through the substrate.

[0027] In some non-limiting embodiments or aspects, the substrate may be axially spaced from a proximal wall of the cavity.

[0028] In some non-limiting embodiments or aspects, the substrate may be a porous foam.

[0029] In some non-limiting embodiments or aspects, the additive may include at least one of an anticoagulant or a coagulant.Page 3 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl

[0030] In some non-limiting embodiments or aspects, the agitator may define a converging fluid flow path.

[0031] In some non-limiting embodiments or aspects, the agitator may define a diverging fluid flow path.

[0032] In some non-limiting embodiments or aspects, the agitator may define a first portion with a converging fluid flow path and a second portion with a diverging fluid flow path.

[0033] In some non-limiting embodiments or aspects, the first portion may be proximal of the second portion.

[0034] In some non-limiting embodiments or aspects, the agitator may include a plug configured to slow a flow rate through the fluid flow path.

[0035] In some non-limiting embodiments or aspects, the plug may be constructed from a porous material.

[0036] In some non-limiting embodiments or aspects, the agitator may be axially spaced from the substrate.

[0037] Further examples of the present disclosure will now be described in the following numbered clauses.

[0038] Clause 1 : A sample collection assembly, comprising: a container having a first end with an opening therein, a second end, and an interior cavity; a stopper sealing the opening, wherein the stopper comprises a chamber and wherein the chamber is configured to receive the sample from a needle piercing the stopper; a substrate enclosing the chamber and permeable to the sample, the substrate containing an additive; and an agitator coupled to the stopper, wherein the agitator is configured to modify a fluid flow characteristic of the sample permeating through the substrate.

[0039] Clause 2: The assembly of clause 1, wherein the substrate is axially spaced from a proximal wall of the cavity.

[0040] Clause 3: The assembly of clause 1 or clause 2, wherein the substrate is a porous foam.

[0041] Clause 4: The assembly of any of clauses 1-3, wherein the additive is at least one of an anticoagulant or a coagulant.

[0042] Clause 5: The assembly of any of clauses 1-4, wherein the agitator defines a converging fluid flow path.

[0043] Clause 6: The assembly of any of clauses 1-5, wherein the agitator defines a diverging fluid flow path.Page 4 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl

[0044] Clause 7: The assembly of any of clauses 1-6, wherein the agitator defines a first portion with a converging fluid flow path and a second portion with a diverging fluid flow path.

[0045] Clause 8: The assembly of clause 7, wherein the first portion is proximal of the second portion.

[0046] Clause 9: The assembly of any of clauses 1-8, wherein the agitator includes a plug configured to slow a flow rate through the fluid flow path.

[0047] Clause 10: The assembly of clause 9, wherein the plug is constructed from a porous material.

[0048] Clause 11 : The assembly of any of clauses 1-10, wherein the agitator is axially spaced from the substrate.

[0049] Clause 12: The assembly of any of clauses 1-11, wherein the container is an evacuated tube.

[0050] Clause 13: A sample collection assembly, comprising: an evacuated tube having a first end with an opening therein, a closed second end, and an interior cavity; a stopper sealing the opening, the stopper defining a chamber in fluid communication with the interior cavity; a porous substrate at least partially positioned within the chamber, the substrate containing an additive configured to react with a sample; and an agitator extending distally from the stopper and configured to modify a fluid flow characteristic of the sample exiting the substrate, the agitator defining at least one of a converging fluid flow path or a diverging fluid flow path between the substrate and the interior cavity.

[0051] Clause 14: A connector, comprising: a proximal end defining a first coupling feature; a distal end defining a second coupling feature; a fluid path extending from the proximal end to the distal end; and a substrate at least partially positioned within the fluid path, the substrate containing an additive configured to react with a sample flowing through the fluid path.

[0052] Clause 15: The connector of clause 14, wherein at least one of the first coupling feature and the second coupling feature is a luer lock connector.

[0053] Clause 16: The connector of clause 14, wherein each of the first coupling feature and the second coupling feature is a luer lock connector.

[0054] Clause 17: The connector of any of clauses 14-16, wherein the substrate is a porous foam.

[0055] Clause 18: The connector of any of clauses 14-17, wherein the additive is at least one of an anticoagulant or a coagulant.Page 5 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl

[0056] Clause 19: A sample collection assembly, comprising: the connector of any of clauses 14-18; and a syringe releasably atachable to the first coupling feature.

[0057] Clause 20: The assembly of clause 19, further comprising a needle hub releasably attached to the second coupling feature.

[0058] Clause 21 : A sample collection assembly, comprising: a stopper configured to seal an opening, wherein the stopper comprises a chamber configured to receive the sample from a needle piercing the stopper; a substrate enclosing the chamber and permeable to the sample, the substrate containing an additive; and an agitator coupled to the stopper, wherein the agitator is configured to modify a fluid flow characteristic of the sample permeating through the substrate.

[0059] Clause 22: The assembly of clause 21, wherein the substrate is axially spaced from a proximal wall of the cavity.

[0060] Clause 23: The assembly of clause 21 or clause 22, wherein the substrate is a porous foam.

[0061] Clause 24: The assembly of any of clauses 21-23, wherein the additive is at least one of an anticoagulant or a coagulant.

[0062] Clause 25: The assembly of any of clauses 21-24, wherein the agitator defines a converging fluid flow path.

[0063] Clause 26: The assembly of any of clauses 21-25, wherein the agitator defines a diverging fluid flow path.

[0064] Clause 27: The assembly of any of clauses 21-26, wherein the agitator defines a first portion with a converging fluid flow path and a second portion with a diverging fluid flow path.

[0065] Clause 28: The assembly of clause 27, wherein the first portion is proximal of the second portion.

[0066] Clause 29: The assembly of any of clauses 21-28, wherein the agitator includes a plug configured to slow a flow rate through the fluid flow path.

[0067] Clause 30: The assembly of clause 29, wherein the plug is constructed from a porous material.

[0068] Clause 31 : The assembly of any of clauses 21-30, wherein the agitator is axially spaced from the substrate.Page 6 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOlBRIEF DESCRIPTION OF THE DRAWINGS

[0069] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:

[0070] FIG. 1 is a cross-sectional view of an example of a sample collection assembly constructed in accordance with the principles of the present invention.

[0071] FIG. 2 is a cross-sectional view of a first end of the sample collection assembly of FIG. 1.

[0072] FIG. 3 is a cross-sectional view of a first end of another example of a sample collection assembly constructed in accordance with the principles of the present invention.

[0073] FIG. 4 is a cross-sectional view of a first end of another example of a sample collection assembly constructed in accordance with the principles of the present invention.

[0074] FIG. 5 is a cross-sectional view of a first end of another example of a sample collection assembly constructed in accordance with the principles of the present invention.

[0075] FIG. 6 is a cross-sectional view of an example of a collection system and exemplary method of use of an example of a sample collection assembly constructed in accordance with the principles of the present invention.

[0076] FIG. 7 is a perspective view of an example of another sample collection assembly constructed in accordance with the principles of the present invention.

[0077] FIG. 8 is a cross-sectional view of a portion of the sample collection assembly of FIG. 7.DESCRIPTION OF THE INVENTION

[0078] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0079] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the concept as it is oriented in the drawing figures. As used herein, the distal end of a component or of a device is to be understood as meaning the end furthest from the user’s hand,Page 7 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl and the proximal end is to be understood as meaning the end closest to the user’s hand. However, it is to be understood that the concept may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the concept. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0080] The word “comprising” and “comprises”, and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, “comprises” means “includes” and “comprising” means “including.”

[0081] As used herein, “at least one of’ is synonymous with “one or more of.” For example, the phrase “at least one of A, B, or C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes A alone; or B alone; or C alone; or A and B; or A and C; or B and C; or all of A, B, and C.

[0082] The term “at least” is synonymous with “greater than or equal to.” The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements. As used herein, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.

[0083] All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. By “about” is meant within plus or minus twenty- five percent of the stated value. However, this should not be considered as limiting to any analysis of the values under the doctrine of equivalents.

[0084] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average values over the specified range and / or ratio.

[0085] As used herein, “sample” means a body fluid suspected of containing an analyte of interest for in vitro diagnostics. Examples of samples include, but are not limited to, a physiological fluid, including, blood, saliva, ocular lens fluid, cerebral spinal fluid, sweat, urine, milk, ascites fluid, mucous, synovial fluid, peritoneal fluid, amniotic fluid, or the like. The sample can be pre-treated prior to use, such as preparing plasma from blood or dilutingPage 8 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl viscous fluids; other pre-treatments can include filtration, distillation, concentration, inactivation of interfering components, and addition of reagents. As such, a sample may be used directly as obtained from the source or following a pretreatment to modify the character of the sample (e.g., after being diluted with another solution or after having been mixed with reagents, e.g., to carry out one or more diagnostic analyses like, e.g., clinical chemistry assays, immunoassays, coagulation assays, nucleic acid testing, etc.). “Sample” therefore is not only used for the original sample but also relates to a sample that has been processed (i.e., pipeted, diluted, mixed with reagents, enriched, having been purified, having been centrifuged, etc.).

[0086] Reference is now made to FIGS. 1-2, which show a sample collection assembly, generally indicated as 10. The sample collection assembly 10 may include a container 12. The container 12 may generally comprise or include, for example, a tube, bottle, vial, flask or the like. The container 12 may be evacuated or under vacuum when sealed. The container 12 may include or define a first end 14, a second end 16 opposite the first end 14, and a sidewall 18 extending between the first end 14 and the second end 16. A longitudinal axis Al may extend along a length of the container 12. The container 12 may include or define an interior cavity 20 therein, and an opening 22 at the first end 14 providing access to the interior cavity 20. The second end 16 of the container 12 may be sealed and / or closed.

[0087] The sample collection assembly 10 may include a stopper 24 configured to seal the opening 22 at the first end 14 of the container 12. The stopper 24 may be constructed from one or materials configured to re-seal after puncture by a cannula, such as one or more rubbers, elastomers, thermoplastics, or the like. In one non-limiting example, the stopper 24 may be at least partially positionable through the opening 22 and into the interior cavity 20. In one nonlimiting example, the stopper 24 may include or define a first portion 26 configured to extend over a top edge or surface of the first end 14 of the container, and may include or define a second portion 28 which extends into and forms an interference fit with an inside surface of the sidewall 18. The first portion 26 may define a flange surface or shoulder to axially abut the top edge or surface of the container 12 defining the opening 22. The first portion 26 may have a diameter or width greater than a diameter or width of the second portion 28 to achieve the sealing and fitment features described herein. In one example, the first portion 26 is proximal to the second portion 28 when the stopper is secured to and / or otherwise seals the opening 22 of the container 12.

[0088] The stopper 24 may include or define a chamber 30 configured to receive a sample injected or delivered through the stopper 12 by a cannula or other instrument. The chamber 30Page 9 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl may be formed by one or more openings or voids in the body of the stopper 24. In one nonlimiting example, the chamber 30 may longitudinally or axially extend through at least a portion of the second portion 28 of the stopper 24. In one example, the chamber 30 may be formed or bordered by a proximal wall 32 defined by the stopper 24, extending to and / or through a distal end or edge 34 of the stopper 24. The chamber 30 may also be formed or defined between one or more interior sidewalls 36 defined by the stopper 24.

[0089] The sample collection assembly 10 may include a substrate 38 at least partially positioned within the chamber 30 of the stopper 24. The substrate may be configured or adapted to introduce an additive to a sample in contact with and / or passing through the substrate into the interior cavity 20 of the container 12. For example, the substrate 38 may include one or more porous materials and an additive contained within or otherwise positioned within the porous structures to mix with a sample. In one non-limiting example, the substrate 38 may include a dry anticoagulant, such as heparin or EDTA, deposited on or within a portion thereof.

[0090] In one non-limiting example, the substrate 38 may include an open cell foam that contains an additive dispersed within the cells of the open cell foam to promote the effectiveness of flow-through sample mixing and additive uptake. As a fluid sample enters the substrate 38, the fluid sample passes through the open cell foam and is exposed to the additive available throughout the internal pore structure of the open cell foam. Examples of open cell foam substrates may include soft deformable open cell foam that is inert to blood and / or other biological fluid samples, such as a melamine foam, and / or a formaldehyde-melamine-sodium bisulfite copolymer. The substrate 38 may also be a flexible, hydrophilic open cell and / or microfiber foam that is substantially resistant to heat and organic solvents, including but not limited to sintered PET fiber foam, extruded foam, or the like. In one embodiment, the substrate 38 may include a sponge material. An additive may be introduced into the substrate 38 by soaking the substrate 38 in a liquid solution of the additive and water and subsequently evaporating the water forming a dry additive powder finely distributed throughout the internal structure of the substrate 38.

[0091] The substrate 38 may comprise one or more layers, and may extend across all and / or a portion of the width of the chamber 30 in a direction substantially perpendicular to the longitudinal axis Al. The substrate 38 may be axially offset or spaced from the proximal wall 32 of the chamber 30 to enable a sample to be introduced and contained within the chamber 30 until absorbed and dispersed through the substrate 38. The substrate 38 may be coupled to one or more of the sidewalls 36 of the chamber 30. For example, the substrate 38 may be adhered,Page 10 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl welded, friction-fit, integrated with and / or otherwise secured to the stopper 24 such that introduction of the fluid sample into the chamber 30 does not dislodge or re-position the substrate 38, thereby ensuring adequate exposure to, and mixing with, the additive within the substrate 38.

[0092] Now referring to FIGS. 3-5, the sample collection assembly 10 may include an agitator 40 coupled to the stopper 24 that is configured or adapted to modify a fluid flow characteristic of a sample exiting the substrate 38. For example, the agitator 40 may include or define one or more structures, geometries, wall, surfaces, or other features that alter fluid flow therethrough, resulting in perturbation, convergence, divergence, or other fluid affect that increases mixing between the fluid sample and the additive introduced into the sample by the substrate 38. The agitator 40 may extend distally from, and / or be axially spaced from the substrate 38 and / or the stopper 24. For example, the agitator 40 may be adhered, welded, friction-fit, integrated with and / or otherwise secured to the stopper 24 and / or the substrate 38 such that introduction of the fluid sample into and through the agitator 40 does not dislodge or re-position the agitator 40.

[0093] In one example, the agitator 40 may provide a converging flow path for a fluid sample exiting the substrate 38 and descending into the interior cavity 20 of the container 12. For example, as shown in FIG. 3, the agitator 40 may include or define a conical, funnel -like, or tapering flow path with a proximal portion 42 having a larger diameter than a distal portion 44 of the flow path. The agitator 40 may include or define an annular portion radially protruding into the flow path with an inwardly-projecting arcuate surface providing the changing diameter and resulting flow features as described. The agitator 40 may define a substantially planar distal surface 46 through which the flow path exits the agitator 40 into the interior cavity 20.

[0094] In another example, the agitator 40 may provide a converging and diverging flow path for a fluid sample exiting the substrate 38 and descending into the interior cavity 20 of the container 12. For example, as shown in FIG. 4, the agitator 40 may include or define a conical, funnel-like, or tapering flow path in a proximal portion 42 of the flow path, and an inverted conical, inverted funnel-like, and / or expanding flow path in a distal portion 44 of the flow path. The diameter of the flow path at an inlet of the flow path in the proximal portion 42 and a diameter of the flow path at an exit in the distal portion 44 may be substantially equal, with an intermediary section of the flow path having a smaller diameter. The agitator 40 may include or define an annular portion protruding into the flow path with an inwardly-projecting semicircular surface providing the changing diameter and resulting flow features as described.Page 11 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl

[0095] In another example, as shown in FIG. 5, the agitator 40 may include a plug 48 at least partially disposed in the fluid flow path passing through the agitator 40. The plug 48 may be configured and / or adapted to slow a flow rate of the sample through the agitator 40 to increase mixing and / or absorption of the additive and the sample. In one example, the plug 48 may be constructed from the same material as the substrate 38, and / or may include one or more porous layers, foam, sponge material, or the like. The plug 48 may be devoid of any additive reactionary to the fluid sample, e.g., the plug may be “non-loaded” and may provide primarily mechanical resistance to a fluid flowing therethrough. The plug 48 may be coupled to one or more sidewalls of the agitator 40 and / or otherwise secured to the agitator 40 such that introduction of the fluid sample into the agitator 40 does not dislodge or re-position the plug 48. The plug 48 may be incorporated into any of the examples of the agitator 40 disclosed herein.

[0096] Now referring to FIG. 6, the sample collection assembly 10 may be coupled to one or more intravenous devices or systems to receive a fluid sample. For example, the container 12 may be coupled to a container holder 50 having a cannula 52 configured to pierce the stopper 24 such that a distal end of the cannula 52 is within the chamber 30 of the stopper 24. A fluid conduit 54 may extend from the container holder 50 and be in fluid communication with the cannula 52. The fluid conduit 54 may be coupled directly and / or indirectly to a distal catheter and / or secondary cannula 56 configured to pierce the patient and receive a fluid sample, which is then transferred or routed through the fluid conduit 54, through the cannula 52, and delivered into the chamber 30. The fluid sample is then exposed to and passes through the substrate 38 to receive the additive stored therein. The sample and the additive are then collectively mixed and routed through the agitator 40, and subsequently pass into the interior cavity 20 of the container.

[0097] Conventional evacuated tube requires manual inversion of tube to mix anticoagulant and stabilize the blood sample. However, this mixing step is open done incorrectly or ignored by healthcare workers. The improper mixing can result in sample quality issues such as erroneous results and re-test. Mixing is technically challenging especially for low volume collection (LVC) tubes due to large headspace or small diameter capillary tube design. The features disclosed herein can improve collection workflow and sample quality.

[0098] For conventional evacuated tube, draw volume needs to be controlled to have acceptable additive-to-blood ratio for sample quality. The tube has a specific recommended draw volume that is controlled by the tube vacuum level during manufacturing. However, it isPage 12 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl difficult to draw up to the recommended draw volume depending on patient condition such as difficult vein access, pediatric, and geriatric cases. The substrate and associated features disclosed herein can release the additive in a controlled way. The controlled release features disclosed herein can allow larger acceptable draw volume range compared to the conventional tube.

[0099] The draw volume also changes over shelf-life due to vacuum loss. This limits the shelf-life. The substrate mixing features disclosed herein can also increase the shelf-life by providing larger acceptable draw volume range.

[0100] Now referring to FIGS. 7-8, another example of a sample collection assembly 100 is provided. The sample collection assembly 100 may include a syringe 102 including a barrel 104 and a plunger 106 movably positionable within the barrel 104. The barrel 104 may include or define a proximal end 110 with an opening to receive the plunger 106, and a flange 110 facilitating manipulation of the barrel 104 and / or plunger 106. The barrel 104 may include or define a distal end 112 with a nozzle or tapered tip 114 in fluid communication with the interior of the barrel 104. The distal end 112 may also include a coupling feature 116 configured to attach the barrel 104 to other components. The coupling feature 116 may include, for example, one or more threaded surfaces, a luer lock interface, and / or other releasably detachable coupling modalities.

[0101] The sample collection assembly 100 may include a connector 118 attachable to the syringe 102. The connector 118 may include or define a proximal end 120, a distal end 122, and a fluid path 124 extending between the proximal end 120 and the distal end 122. The proximal end 120 may include a first coupling feature 126 configured to engage the distal end 112 of the syringe 102. The first coupling feature 126 may include, for example, one or more threaded surfaces, a luer lock interface, a tapered inlet, or other releasably detachable coupling modalities. The distal end 122 may include a second coupling feature 128, which may include, for example, one or more threaded surfaces, a luer lock interface, a tapered outlet, and / or other releasably detachable coupling modalities.

[0102] The connector 118 may include a substrate 130 at least partially positioned within the fluid path 124. The substrate 130 may be similar in form and function to that of substrate 38 as disclosed herein. The substrate 130 may be a porous structure with an additive contained therein configured to mix and react with a fluid sample passing through the fluid path 124.Page 13 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl

[0103] The connector 118 may have a unitary construction, and / or may be constructed from one or more transparent materials to enable visibility of fluid flow therethrough, which may aid a healthcare professional in viewing flashback within the collection assembly 100.

[0104] The sample collection assembly 100 may include a needle hub 132 releasably attachable to the distal end 122 of the connector 118. In one example, the needle hub 132 may be connectable and / or engageable with the second coupling feature 128 of the connector. The needle hub 132 may include a cannula 134 coupled thereto that is in fluid communication with the fluid path 124 of the connector 118 when the needle hub 132 is attached to the connector 118. In another example, the distal end 122 of the connector 118 may be coupled to one or more fluid components, IV lines, hubs, adapters, catheters, or the like to receive a fluid sample into the distal end 122 of the connector 118, through the fluid path 124 and the substrate 130, and to the interior of the barrel 104 of the syringe 102.

[0105] As a result, a fluid sample drawn into the connector 118 and delivered to the syringe 102 via the actuation of the plunger 106 is exposed to and mixed with the additive in the substrate 130 prior to entering the syringe 102. In addition to the additive distribution and mixing benefits described herein associated with the substrates, the modularity of the connector 118 and the embedded substrate 130 therein being separate from the syringe 102 enables a selection amongst various connectors and additives to be used with a single supply of uniform, non-additive containing syringes.

[0106] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. Of note, the system components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Moreover, while certain embodiments or figures described herein may illustrate features not expressly indicated on other figures or embodiments, it is understood that the features and components of the examples disclosed herein are not necessarily exclusive of each other and may be included in a variety of different combinations or configurations without departing from the scope and spirit of the disclosure. A variety of modifications and variations are possible in light of the above teachings withoutPage 14 of 206884493. DOCXAttorney Docket No. 03896-2505739P-29893.WOOl departing from the scope and spirit of the disclosure, which is limited only by the following claims.Page 15 of 206884493.DOCX

Claims

1. Atorney Docket No. 03896-2505739P-29893.WOOlWhat is claimed is:

1. A sample collection assembly, comprising: a container having a first end with an opening therein, a second end, and an interior cavity; a stopper sealing the opening, wherein the stopper comprises a chamber and wherein the chamber is configured to receive the sample from a needle piercing the stopper; a substrate enclosing the chamber and permeable to the sample, the substrate containing an additive; and an agitator coupled to the stopper, wherein the agitator is configured to modify a fluid flow characteristic of the sample permeating through the substrate.

2. The sample collection assembly of claim 1, wherein the substrate is axially spaced from a proximal wall of the cavity.

3. The sample collection assembly of claim 1, wherein the substrate is a porous foam.

4. The sample collection assembly of claim 1, wherein the additive is at least one of an anticoagulant or a coagulant.

5. The sample collection assembly of claim 1, wherein the agitator defines a converging fluid flow path.

6. The sample collection assembly of claim 1, wherein the agitator defines a diverging fluid flow path.

7. The sample collection assembly of claim 1, wherein the agitator defines a first portion with a converging fluid flow path and a second portion with a diverging fluid flow path.

8. The sample collection assembly of claim 7, wherein the first portion is proximal of the second portion.Page 16 of 206884493. DOCXAtorney Docket No. 03896-2505739P-29893.WOOl9. The sample collection assembly of claim 1, wherein the agitator includes a plug configured to slow a flow rate through the fluid flow path.

10. The sample collection assembly of claim 9, wherein the plug is constructed from a porous material.

11. The sample collection assembly of claim 1, wherein the agitator is axially spaced from the substrate.

12. The sample collection assembly of claim 1, wherein the container is an evacuated tube.

13. A sample collection assembly, comprising: an evacuated tube having a first end with an opening therein, a closed second end, and an interior cavity; a stopper sealing the opening, the stopper defining a chamber in fluid communication with the interior cavity; a porous substrate at least partially positioned within the chamber, the substrate containing an additive configured to react with a sample; and an agitator extending distally from the stopper and configured to modify a fluid flow characteristic of the sample exiting the substrate, the agitator defining at least one of a converging fluid flow path or a diverging fluid flow path between the substrate and the interior cavity.

14. A connector, comprising: a proximal end defining a first coupling feature; a distal end defining a second coupling feature; a fluid path extending from the proximal end to the distal end; and a substrate at least partially positioned within the fluid path, the substrate containing an additive configured to react with a sample flowing through the fluid path.Page 17 of 206884493. DOCXAttorney Docket No. 03896-2505739P-29893.WOOl15. The connector of claim 14, wherein at least one of the first coupling feature and the second coupling feature is a luer lock connector.

16. The connector of claim 15, wherein each of the first coupling feature and the second coupling feature is a luer lock connector.

17. The connector of claim 14, wherein the substrate is a porous foam.

18. The connector of claim 14, wherein the additive is at least one of an anticoagulant or a coagulant.

19. A sample collection assembly, comprising: the connector of claim 14; and a syringe releasably attachable to the first coupling feature.

20. The sample collection assembly of claim 19, further comprising a needle hub releasably attached to the second coupling feature.

21. A sample collection assembly, comprising: a stopper configured to seal an opening, wherein the stopper comprises a chamber configured to receive the sample from a needle piercing the stopper; a substrate enclosing the chamber and permeable to the sample, the substrate containing an additive; and an agitator coupled to the stopper, wherein the agitator is configured to modify a fluid flow characteristic of the sample permeating through the substrate.

22. The sample collection assembly of claim 21, wherein the substrate is axially spaced from a proximal wall of the cavity.

23. The sample collection assembly of claim 21, wherein the substrate is a porous foam.Page 18 of 206884493.DOCXAttorney Docket No. 03896-2505739P-29893.WOOl24. The sample collection assembly of claim 21 wherein the additive is at least one of an anticoagulant or a coagulant.

25. The sample collection assembly of claim 21, wherein the agitator defines a converging fluid flow path.

26. The sample collection assembly of claim 21, wherein the agitator defines a diverging fluid flow path.

27. The sample collection assembly of claim 21, wherein the agitator defines a first portion with a converging fluid flow path and a second portion with a diverging fluid flow path.

28. The sample collection assembly of claim 27, wherein the first portion is proximal of the second portion.

29. The sample collection assembly of claim 21, wherein the agitator includes a plug configured to slow a flow rate through the fluid flow path.

30. The sample collection assembly of claim 29, wherein the plug is constructed from a porous material.

31. The sample collection assembly of claim 21, wherein the agitator is axially spaced from the substrate.Page 19 of 206884493.DOCX

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