Apparatus and method for transferring a fluid sample from a fluid sampling device to a liquid sample analyzer - Patent Application 20070122997

Abstract

An apparatus and method for transferring a fluid sample from a fluid sampling device to a liquid sample analyzer. The apparatus includes a barrel having a first end, a second end, a sidewall extending between the first end and the second end, an inner surface defining an interior chamber, and an outer surface defining at least a portion of a chromatographic assay chamber in fluid communication with the interior chamber. The first end has an inlet opening with a clot catcher extending across the inlet opening upstream of a passageway, and the second end has an outlet opening. A chromatographic assay assembly is received in the chromatographic assay chamber for detecting the presence of free hemoglobin in the fluid sample.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 63 / 369,522, filed July 27, 2022; U.S. Provisional Application No. 63 / 367,239, filed June 29, 2022; U.S. Provisional Application No. 63 / 366,558, filed June 17, 2022; U.S. Provisional Application No. 63 / 244,987, filed September 16, 2021; and U.S. Provisional Application No. 63 / 232,365, filed August 12, 2021. The entire contents of the above-referenced patent applications are expressly incorporated herein by reference. [Background technology]

[0002] Blood sampling is a common healthcare procedure typically used in hospital and laboratory settings to determine a patient's physiological and biochemical status. Blood sampling is essential for the diagnosis and treatment of patients suspected of a wide variety of diseases. Blood samples are analyzed by fluid testing devices, such as hematology analyzers, to detect clinically significant variations in blood components, such as plasma, red blood cells, white blood cells, and platelets, or other characteristics, such as blood gas status. Analysis of blood samples for blood gas status provides information about the amount of oxygen and carbon dioxide in the blood and can also be used to measure the pH of the blood sample. Imbalances in oxygen, carbon dioxide, or pH levels in a blood sample may indicate certain pathological conditions or advanced stages of disease.

[0003] Blood samples are typically collected using a blood collection syringe with a hypodermic needle or an evacuated tube connected to a needle assembly. However, blood collection syringes are prone to trapping air or other gas bubbles within the syringe. Air bubbles in the syringe barrel and tip can interfere with blood sample analysis. For blood gas analysis, trapped air bubbles within the syringe can cause erroneous results on the hematology analyzer. To obtain accurate results, the blood sample must be thoroughly mixed, but all air must be expelled before mixing. Air bubbles are typically expelled by gently tapping the side of the syringe to force the air or gas to the top of the syringe. Once the bubbles reach the top of the syringe, a piece of gauze or tissue is placed over the top to expel the gas (and some blood) from the syringe. This method not only poses a biohazard risk because the blood sample flows freely out the top of the syringe, but also poses a risk of exposure because the syringe tip remains exposed to ambient air. A blood analyzer analyzing a blood sample collected in this manner is at risk of producing erroneous results.

[0004] Furthermore, hematology analyzers often do not allow for direct sample loading via a syringe or vacuum tube. In this case, the syringe and / or vacuum tube is merely an intermediate container for the blood sample, and at least a portion of the blood sample must be removed and transferred to a secondary sample container that can be accommodated by the hematology analyzer. Transferring the blood sample to a secondary sample container presents its own risk of exposure and increases the likelihood of obtaining erroneous results.

[0005] Blood clots in blood samples can also cause erroneous results, leading to inappropriate treatment, and can cause blockages in the blood analyzer, leading to delayed results, damage to the analyzer, or the need to replace consumables, all of which can be costly.

[0006] Hemolysis in a blood sample is typically time-consuming to detect. Typically, the user must centrifuge the sample and compare the color of the plasma to the hemolysis index. This requires access to expensive equipment, such as a centrifuge, and is time-consuming. Meanwhile, testing without checking for hemolysis can prolong delays because unexpectedly high potassium can cast doubt on the entire test result, leading to delayed treatment and increased costs while repeat sampling and testing is performed.

[0007] Secondary sample containers are often open-ended (i.e., lack a male fitting) and therefore not compatible for "hands-free" use with the analyzer. That is, in prior art systems, the user must hold the syringe while using it with the analyzer (i.e., not hands-free), or the syringe is not compatible and cannot be used with an adapter attached to the analyzer in a hands-free manner. Many syringe attachments (e.g., adapters) exist and are compatible with blood gas analyzers. However, these syringe attachments do not allow for "hands-free" connection or attachment to the blood analyzer; the operator must remain in front of the analyzer and hold the syringe while drawing a sample. In prior art systems, if the operator wanted to use the blood gas analyzer hands-free, they had to remove the adapter from the syringe before attaching the syringe directly to the analyzer (without the adapter) while the analyzer was in use. This is sufficient with bubble removal adapters, but when using clot catcher adapters, removing the adapter negates the benefits of the device. Summary of the Invention [Problem to be solved by the invention]

[0008] There is a need for an apparatus and method that enables one or more of hemolysis detection, clot removal, hands-free connection of a blood sampling device to a blood gas analyzer, and removal of air bubbles from a fluid sample. The inventive concepts disclosed and claimed herein are directed to such an apparatus and method. [Means for solving the problem]

[0009] The inventive concepts disclosed and claimed herein generally relate to an apparatus for transferring a fluid sample having a liquid portion and a gas portion from a fluid sampling device to a liquid sample analyzer. The apparatus includes a barrel and a chromatographic assay assembly. The barrel has a first end, a second end opposite the first end, a sidewall extending between the first end and the second end, an inner surface defining an internal chamber, and an outer surface defining at least a portion of the chromatographic assay chamber in fluid communication with the internal chamber via a passageway through the outer surface of the barrel. The first end of the barrel has an inlet opening with a clot catcher extending across the inlet opening upstream of the passageway, and the second end has an outlet opening.

[0010] The chromatographic assay assembly is housed in the chromatographic assay chamber and is configured to detect the presence of free hemoglobin in a fluid sample. The chromatographic assay assembly includes a sample application pad and a chromatographic detection pad. The sample application pad is configured to receive the fluid sample from the internal chamber. The sample application pad is formed from a first layer of a pre-filtration material and a second layer of an asymmetric polysulfone material, and the sample application pad is permeable to plasma and free hemoglobin but not to red blood cells. The chromatographic detection pad is in fluid contact with the sample application pad and is configured to detect the presence of free hemoglobin.

[0011] In another aspect, the inventive concepts disclosed and claimed herein generally relate to a kit including the apparatus described above and a reference device containing a plurality of reference colors, each corresponding to a different level of hemolysis.

[0012] In another aspect, the inventive concepts disclosed and claimed herein generally relate to a method for transferring a fluid sample having a liquid portion and a gas portion from a fluid sampling device to a liquid sample analyzer having a sample probe. The method includes obtaining a device having a barrel having a first end with an inlet opening across which a clot catcher extends, a second end with an outlet opening, a sidewall extending between the first and second ends, and an interior surface defining an interior chamber. At least a portion of the fluid sample is transferred from the fluid sampling device through the inlet opening to the interior chamber of the barrel such that the fluid sample passes through the clot catcher at the inlet opening to capture solids in the fluid sample. A portion of the fluid sample is transferred from the interior chamber of the barrel to a chromatographic assay chamber and a chromatographic assay assembly housed in the chromatographic assay chamber. The chromatographic assay chamber is in fluid communication with the interior chamber downstream of the clot catcher. The presence of free hemoglobin in the fluid sample is detected by the chromatographic assay assembly. The fluid sample is transferred from the internal chamber to the liquid sample analyzer using a sample probe.

[0013] To assist those of ordinary skill in the relevant art in making and using the inventive concepts disclosed herein, reference is made to the accompanying drawings and illustrations. The drawings are not intended to be drawn to scale, and for the sake of consistency, like reference numerals are intended to refer to identical or similar elements. For the sake of clarity, not every component may be labeled in every drawing. Certain configurations and particular perspectives of the figures may be shown exaggerated, not to scale, or diagrammatically for the sake of clarity and conciseness. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a side perspective view of an exemplary embodiment of an apparatus for removing bubbles in accordance with the inventive concepts disclosed herein shown coupled to a sample receiving assembly; FIG. [Figure 2A]2 is a longitudinal cross-sectional view of the device of FIG. 1 connected to a sampling syringe, showing the position of the filter element and plunger assembly prior to removing air bubbles from the fluid sample. [Figure 2B] 2 is a longitudinal cross-sectional view of the device of FIG. 1 connected to a sampling syringe, showing the position of the filter element and plunger assembly after removing air bubbles from the fluid sample. [Figure 2C] 2 is a longitudinal cross-sectional view of the device of FIG. 1 connected to a sampling syringe, showing the insertion of a probe into the device after removing air bubbles from the fluid sample. [Figure 3A] 2 is a longitudinal cross-sectional view of the device of FIG. 1 showing the position of the filter element prior to removing air bubbles from the fluid sample. [Figure 3B] 2 is a longitudinal cross-sectional view of the device of FIG. 1 showing the position of the filter element after removing air bubbles from the fluid sample. [Figure 3C] 2 is a longitudinal cross-sectional view of the device of FIG. 1 showing the insertion of a probe into the device after removing air bubbles from the fluid sample. [Figure 4A] FIG. [Figure 4B] FIG. 4B is a cross-sectional view taken along line 4B-4B of FIG. 4A. [Figure 5] FIG. [Figure 6A] 1 is a perspective view of an exemplary embodiment of a filter element in accordance with the inventive concepts disclosed herein; [Figure 6B] FIG. 6B is a cross-sectional view taken along line 6B-6B of FIG. 6A. [Figure 7] 10 is a perspective view of another embodiment of a filter element in accordance with the inventive concepts disclosed herein; FIG. [Figure 8A] 10 is a perspective view of another embodiment of a filter element in accordance with the inventive concepts disclosed herein; FIG. [Figure 8B] 8B is a cross-sectional view taken along line 8B-8B of FIG. 8A. [Figure 9] FIG. 10 is a perspective view of another exemplary embodiment of an apparatus in accordance with the inventive concepts disclosed herein. [Figure 10A]FIG. 10A is a cross-sectional view taken along line 10A-10A of FIG. 9. [Figure 10B] 10B is a cross-sectional view taken along line 10B-10B of FIG. 9. [Figure 10C] FIG. 10C is a cross-sectional view taken along line 10C-10C of FIG. 9. [Figure 10D] FIG. 10D is a cross-sectional view taken along line 10D-10D of FIG. 9. [Figure 11] FIG. 10 is a longitudinal cross-sectional view of a portion of the device of FIG. 9 shown connected to a sampling syringe. [Figure 12] FIG. 10 is a partially exploded perspective view of the device of FIG. 9, showing the chromatographic assay assembly removed. [Figure 13A] FIG. 1 is a perspective view of a non-limiting embodiment of a chromatographic assay assembly constructed in accordance with the inventive concepts disclosed herein. [Figure 13B] FIG. 13B is a perspective view showing a workflow for using the chromatographic assay assembly of FIG. 13A. [Figure 14] FIG. 14 is a cross-sectional view taken along line 14-14 of FIG. 9. [Figure 15] FIG. 1 is a schematic diagram of one non-limiting embodiment of a reference device for use with a chromatographic assay assembly constructed in accordance with the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0015] Before describing in detail at least one embodiment of the inventive concepts through illustrative figures, experiments, results, and experimental procedures, it is to be understood that the inventive concepts are not limited in their application to the details of construction and arrangements of components set forth in the following description or illustrated in the figures, experiments, and / or results. The inventive concepts are capable of other embodiments or of being practiced or carried out in various ways. The language used herein is intended to be accorded the broadest possible scope and meaning; the embodiments are intended to be illustrative and not exhaustive. It is also to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0016] Unless otherwise defined, scientific and technical terms used in connection with the presently disclosed and claimed inventive concepts shall have the meanings commonly understood by those of ordinary skill in the art. Furthermore, unless otherwise required by context, singular terms shall include the plural and plural terms shall include the singular. The foregoing techniques and procedures are generally carried out according to conventional methods well known in the art, as described in various general and more specific references cited and discussed throughout this specification. The nomenclature utilized in connection with analytical chemistry, synthetic organic chemistry, and medicinal chemistry described herein, as well as the laboratory procedures and techniques thereof, are well known and commonly used in the art. Standard techniques are used for chemical syntheses and chemical analyses.

[0017] All of the articles, compositions, and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the articles, compositions, and methods of the inventive concepts have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that modifications can be made in those articles, compositions, and / or methods, and in the steps or sequence of steps of the methods described herein, without departing from the concept, spirit, and scope of the inventive concepts. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the inventive concepts as defined by the appended claims.

[0018] As utilized herein, the following terms, unless otherwise specified, shall be understood to have the following meanings:

[0019] When used in conjunction with the term "comprising" in the claims and / or specification, the use of the words "a" or "an" can mean "one," but is also consistent with the meanings of "one or more," "at least one," and "one or more."

[0020] Use of the term "or" in the claims is used to mean "and / or" unless expressly indicated to refer to alternatives only or unless the alternatives are mutually exclusive; however, the present disclosure supports a definition that refers to alternatives only and "and / or."

[0021] Throughout this application, the term "about" is used to indicate that a value includes the inherent variation of error that exists for the device, the method employed to determine the value, or among testing subjects.

[0022] Use of the term "at least one" will be understood to include not only one but any multiple amount, including, but not limited to, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 100, etc. The term "at least one" can extend up to 100 or 1000 or more, depending on the term to which it is attached; further, an amount of 100 / 1000 is not to be considered limiting, as higher limits may also provide satisfactory results. Additionally, use of the term "at least one of X, Y, and Z" will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z.

[0023] As used in this specification and claims, the words "comprising" (and any form of "comprising," such as "comprise" and "comprises"), "having" (and any form of "having," such as "have" and "has"), "including" (and any form of "including," such as "includes" and "include"), or "containing" (and any form of "containing," such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0024] As used herein, the term "or combinations thereof" refers to all permutations and combinations of the items listed before that term. For example, "A, B, C, or combinations thereof" is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and, where order is important in the particular context, BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, combinations including repeats of one or more items or terms are expressly included, such as BB, AAA, MB, BBC, AAABCCCC, CBBAAA, CABABB, etc. Those of skill in the art will understand that typically there is no limit to the number of items or terms in any combination unless otherwise apparent from the context.

[0025] As used herein, the term "sample" and variations thereof is intended to include, for example, biological tissue, biological fluid, chemical fluid, chemical, suspension, solution, slurry, mixture, aggregate, tincture, slide, powder, or other preparation of biological tissue or fluid, synthetic analogs of biological tissue or fluid, bacterial cells (prokaryotic or eukaryotic), viruses, unicellular organisms, lysed biological cells, fixed biological cells, fixed biological tissue, cell cultures, tissue cultures, genetically modified cells and tissues, genetically modified organisms, and combinations thereof.

[0026] In the following detailed description of embodiments of the inventive concepts, several specific details are set forth to provide a more thorough understanding of the inventive concepts. However, it will be apparent to those skilled in the art that the inventive concepts within this disclosure may be practiced without these specific details. In other instances, well-known features have not been described in detail to avoid unnecessarily complicating the disclosure.

[0027] Finally, as used herein, any reference to "one embodiment" or "an embodiment" means that a particular element, configuration, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" in various places in this specification are not necessarily all referring to the same embodiment.

[0028] Described herein and shown in the accompanying drawings are several non-limiting embodiments of devices of the presently claimed and disclosed inventive concepts used in conjunction with a collection syringe and a liquid sample analyzer to remove air or other gas bubbles from a fluid sample for analysis by the liquid sample analyzer. The fluid sample is generally derived from a biological source. "Fluid" refers to any substance that does not have a fixed shape and that readily yields to external pressure.

[0029] 1-5, there is shown an exemplary embodiment of an apparatus 10 for transferring a fluid sample from a liquid sampling device to a liquid sample analyzer and removing air bubbles from the fluid sample, constructed in accordance with the inventive concepts disclosed and claimed herein. Apparatus 10 includes a barrel 12, a nozzle cap 14, and a filter member 16.

[0030] The barrel 12 includes a first end 18, a second end 20, a sidewall 22, and an interior surface 24. The barrel 12 may be of any suitable size and shape and formed of any suitable material, such as, but not limited to, plastics such as polycarbonate, polystyrene, polyacrylate, and polyurethane, or medical-grade polymers. The sidewall 22 of the barrel 12 extends between the first end 18 and the second end 20 of the barrel 12. The interior surface 24 of the barrel 12 defines an interior chamber 26. The first end 18 has an inlet opening 28, and the second end 20 has an outlet opening 30.

[0031] The internal chamber 26 may be of any suitable size and shape to accommodate the fluid sample 32. The fluid sample 32 may be a liquid biological sample, such as blood, serum, plasma, or other bodily fluid. The fluid sample 32 may include a gas portion and a liquid portion. The gas portion of the fluid sample 32 may be, for example, air or other gas. Some of the gas portion may form bubbles in the fluid sample.

[0032] The inlet opening 28 and the outlet opening 30 can have any suitable cross-sectional geometry, including, but not limited to, circular, oval, square, or rectangular. The inlet opening 28 and the outlet opening 30 are molded, machined, or otherwise prefabricated into the barrel 12. The inlet opening 28 is configured to capture thrombus as the fluid sample 32 enters the internal chamber 26 through the inlet opening 28. The barrel 12 can include a thrombus catcher 33 ( FIG. 5 ) positioned across the inlet opening 28 to define a plurality of apertures 35 sized and shaped to allow fluid to enter the internal chamber 26 but to capture or prevent solid objects (i.e., thrombus) larger than a predetermined size from entering the internal chamber 26. Solid objects captured by the thrombus catcher 33 and prevented from entering the internal chamber 26 include, for example, thrombus and other solid objects present in the fluid sample 32 having a predetermined size of at least about 0.17±0.05 mm in diameter or larger. In one non-limiting embodiment, thrombus catcher 33 is star-shaped (e.g., shown as thrombus catcher 133 in FIGS. 10C and 10D ) so as to cooperate with inlet opening 28 to define five apertures 35 (only one of which is numbered in FIG. 5 ) through which fluid can enter internal chamber 26. In this non-limiting embodiment, the five apertures 35 are formed between five arms of star-shaped thrombus catcher 33, the size and shape of which can function as capture elements (e.g., as shown in FIG. 10C as thrombus catcher 133 with aperture 135) to capture thrombus and prevent it from entering internal chamber 26.

[0033] The outlet opening 30 may be provided with a nozzle cap 14. The nozzle cap 14 includes an annular wall 36 and a tubular portion 38 having a bore 40 extending therethrough. The tubular portion 38 may be in the form of a male luer for frictionally engaging a portion of a fluid analyzer 68 (FIG. 1). The liquid sample analyzer 68 includes a sample entry port 70 for frictionally receiving the tubular portion 38 and a sample probe 72 (FIGS. 2C and 3C). The sample probe 72 may be axially slidable relative to the sample entry port 70. The bore 40 may have a cross-section of any suitable geometry, including, but not limited to, circular, oval, square, or rectangular. The bore 40 is sized to have a diameter adapted to axially slidably receive the sample probe. The base of the tubular portion 38 flares outward and meets the annular wall 36 at a rim 42, which tapers downward to form an inverted frustoconical cross-section. Nozzle cap 14 is releasably coupled to outlet opening 30 such that bore 40 is aligned with outlet opening 30 to allow fluid communication with interior chamber 26 .

[0034] The filter element 16 is positioned within the internal chamber 26 such that the filter element 16 defines an inlet side 44 and an outlet side 46 of the internal chamber 26. The filter element 16 may be located between the first end 18 and the second end 20 of the barrel 12. The filter element 16 includes at least one gas-permeable, liquid-impermeable membrane 48. The filter element 16 may be of any suitable shape and size that sealably engages with the internal surface 24 of the barrel 12. The filter element 16 may be formed of any suitable material, such as, but not limited to, rubber, elastomer, polyolefin-based resin, fluororesin, or polyester-based resin. Examples of elastomers include polyvinyl chloride-based elastomers, polyolefin-based elastomers, styrene-based elastomers, polyester-based elastomers, polyamide-based elastomers, polyurethane-based elastomers, or mixtures thereof.

[0035] 6A and 6B, perspective and cross-sectional views, respectively, of an exemplary embodiment of a filter member 16 are shown. The filter member 16 includes a body 50 having a first end 52, a second end 54, and a sidewall 56 extending from the first end 52 to the second end 54. The sidewall 56 of the body 50 defines a passageway 58 extending through the body 50 from the first end 52 to the second end 54. The sidewall 56 of the body 50 may have at least two annular protrusions 60 extending radially outward in slidable sealing contact with the inner surface 24 of the barrel 12. As shown in FIGS. 6A and 6B, the body 50 may have two annular protrusions 60 spaced apart from one another. The annular protrusions 60 may have a convex or concave configuration.

[0036] The filter member 16 further includes a gas-permeable, liquid-impermeable membrane 48 that extends across the passageway 58. In one embodiment, the gas-permeable, liquid-impermeable membrane 48 is secured to the body 50 adjacent the second end 54 of the body 50, as shown in FIG.

[0037] Referring now to FIG. 7, a perspective view of another embodiment of a filter element 16a constructed in accordance with the inventive concepts disclosed and claimed herein is shown. Similar to the previously described embodiment, the filter element 16a includes a body 50a having a first end 52a, a second end 54a, and a sidewall 56a extending from the first end 52a to the second end 54a. The sidewall 56a of the body 50a defines a passageway 58a (not shown) extending through the body 50a from the first end 52a to the second end 54a. As in FIGS. 6A and 6B of the previously described embodiment, the body 50a can have at least two annular projections 60b extending radially outward in slidable sealing contact with the inner surface 24 of the barrel 12. As shown in FIG. 7, the body 50a can have three annular projections 60a spaced apart from one another. The filter member 16a further includes a gas-permeable, liquid-impermeable membrane 48 that extends across the passageway 58a. In this embodiment, the gas-permeable, liquid-impermeable membrane 48 is secured to the body 50a adjacent the body second end 54a.

[0038] 8A and 8B, perspective and cross-sectional views, respectively, of another embodiment of a filter member 16b are shown. The filter member 16b includes a body 50b having a first end 52b, a second end 54b, and a sidewall 56b extending from the first end 52b to the second end 54b. Similar to the previous embodiment, the body 50b may have at least two annular projections 60b extending radially outward in slidable sealing contact with the inner surface 24 of the barrel 12. The sidewall 56b of the body 50b defines a plurality of passages 58b extending through the body 50b from the first end 52b to the second end 54b. In this embodiment, the passages 58b may be in a parallel relationship to one another, as shown in FIG. 8B. Additionally, the filter member 16b may include a plurality of gas-permeable, liquid-impermeable membranes 48b, at least one of which extends across each of the plurality of passages 58b in the body 50b. The filter member 16b may further include a plurality of porous filter materials 62 positioned between the first end 52b of the body 50b and each of the plurality of gas-permeable, liquid-impermeable membranes 48b to prevent solid particulates from contacting the plurality of gas-permeable, liquid-impermeable membranes 48b, as shown in FIG. 8B.

[0039] The at least one gas-permeable, liquid-impermeable membrane 48 may be formed from any suitable material, such as, but not limited to, polytetrafluoroethylene, polyvinylidene fluoride, polyvinyl chloride, polyolefins such as polypropylene, polyethylene, polymethylpentene, polyamide, polysulfone, polyetheretherketone, polycarbonate, and combinations thereof. In one embodiment, the gas-permeable, liquid-impermeable membrane 48 may be formed from a material including at least one of polytetrafluoroethylene, polypropylene, and polyethylene. The at least one gas-permeable, liquid-impermeable membrane 48 may have a thickness suitable for permitting puncture when mechanical force is applied. The at least one gas-permeable, liquid-impermeable membrane 48 may allow at least a portion of the gaseous portion of the fluid sample 32 that forms bubbles to pass through the filter member 16 from the inlet side 44 to the outlet side 46 of the internal chamber 26. The at least one gas-permeable, liquid-impermeable membrane 48 further provides a fluid-tight seal across the filter member 16 to prevent the liquid portion of the fluid sample 32 from passing from the inlet side 44 to the outlet side 46 when the fluid sample 32 enters the interior chamber 26 through the inlet opening 28 to separate at least a portion of the gas portion from the liquid portion of the fluid sample 32. The filter member 16 is piercable so that a sample probe 72 is passed through the filter member 16 from the outlet side 46 to the inlet side 44 to draw the liquid portion of the fluid sample 32 from the inlet side 44 of the interior chamber 26.

[0040] As shown in Figure 1, the apparatus 10 can be used in conjunction with a fluid sample collection device, such as a collection syringe 66 and a liquid sample analyzer 68, to transfer a fluid sample from the collection syringe 66 to the liquid sample analyzer 68 and to remove air bubbles from a fluid sample 32 having a liquid portion and a gas portion. While Figure 1 shows the apparatus 10 with the collection syringe 66 and the liquid sample analyzer 68, those skilled in the art will understand and appreciate that the apparatus 10 is independently related to collection devices other than the collection syringe 66, such as, for example, an evacuated tube, and medical devices other than the liquid sample analyzer 68. The liquid sample analyzer 68 can be any suitable fluid testing device, such as, but not limited to, a microfluidic device, a blood gas analyzer, a hematology analyzer, a urine chemistry analyzer, or the like.

[0041] Liquid sample analyzer 68 includes a sample entry port 70 and a sample probe 72 (FIGS. 2C and 3C). Sample entry port 70 is sized to frictionally receive and removably secure at least a portion of nozzle cap 14, as shown in FIG. 1, to allow for "hands-free" operation of liquid sample analyzer 68 such that a fluid sample within device 10 can be drawn into liquid sample analyzer 68 via sample probe 72 without the user having to hold device 10 (e.g., a female luer).

[0042] 2C and 3C, the sample probe 72 can extend through the filter member 16 from the outlet side 46 to the inlet side 44 of the internal chamber 26 to draw at least a portion of the fluid sample 32 from the inlet side 44 of the internal chamber 26 into the liquid sample analyzer 68. The sample probe 72 can be of a length compatible with sampling from the inlet side 44 of the internal chamber 26.

[0043] The collection syringe 66 includes a syringe body 74 having a front end 76, a rear end 78, and a plunger 80. The syringe body 74 defines a reservoir 82 in which the fluid sample 32 is contained and subsequently discharged through a dispensing opening 84 located at the front end 76 of the syringe body 74. The rear end 78 of the syringe body 74 is open and may include a body flange 85 to facilitate collection and discharge of the fluid sample 32. The syringe body 74 may be of any size or shape suitable for collection of a fluid sample, such as, for example, cylindrical. The syringe body 74 may also include a collar 77 formed concentrically within the cylinder to surround the dispensing opening 84. The collar 77 may include an inner periphery on which a threaded engagement 79 is formed for engaging the device 10. The syringe body 74 may be constructed of any suitable material, such as glass or plastic. The syringe body 74 can have an outer diameter adapted to slide coaxially within the first end 18 of the device 10 .

[0044] The plunger 80 may include a shaft 86 terminating at one end in a plunger flange 88 to facilitate collection and ejection of the fluid sample 32. The shaft 86 may have, for example, a cylindrical or columnar shape and may have a polygonal cross-section, such as a square, pentagonal, hexagonal, or cruciform shape. The plunger 80 may further include a plunger seal 90 secured to the shaft 86 opposite the plunger flange 88. The plunger 80 may be removably disposed within the syringe body 74 and selectively movable within the reservoir 82. The plunger seal 90 has a diameter that enables the plunger seal 90 to create a fluid-tight seal when positioned within the reservoir 82 to prevent the liquid sample 32 from migrating past the plunger seal 90. Furthermore, the plunger seal 90 prevents ambient air from migrating from the rear end 78 of the syringe body 74 past the plunger seal 90. The plunger 80 is axially displaceable relative to the syringe body 74. Movement of plunger 80 from rear end 78 to front end 76 of syringe body 74 expels at least a portion of fluid sample 32 from reservoir 82 and directs it through dispensing opening 84 to inlet opening 28 of device 10. Plunger 80 may be constructed of any suitable polymeric material known in the art.

[0045] To remove the gas portion (i.e., air bubbles) of the fluid sample 32 from the liquid portion, a sampling syringe 66 containing a volume of the fluid sample 32 in a reservoir 82 is releasably attached to the first end 18 of the barrel 12, as shown in Figure 2A. A front end 76 of a syringe body 74 is interlockingly engaged to the device 10 via a threaded engagement 79, as shown in Figures 2A-2C.

[0046] As shown in FIGS. 4A and 4B , the barrel 12 can include a barrel connection 94. In one embodiment, the threaded engagement portion 79 of the syringe body 74 is a male luer connection, and the barrel connection 94, in one exemplary embodiment, is a female luer connector including a pair of threaded lugs 95 extending radially from the exterior of the barrel 12 and having a thread pitch, size, and geometry corresponding to the threaded engagement portion 79 of the syringe body 74. As shown in FIGS. 2A-2C , the threaded engagement portion 79 can interlockingly engage the barrel connection 94 to prevent significant relative movement between the collection syringe 66 and the device 10, allowing for "hands-free" operation of the liquid sample analyzer such that a fluid sample from within the collection syringe 66 can be drawn through the device 10 and into the liquid sample analyzer without the user having to hold the collection syringe 66 or the device 10. It will be appreciated that other suitable connectors, such as a luer slip connection, may be utilized between the device 10 and the collection syringe 66. The first end 18 of the barrel 12 may include a female luer 96 (FIGS. 3A and 5).

[0047] In use, the sampling syringe 66 and device 10 are positioned in an upright position with the device 10 above the sampling syringe 66, causing any air bubbles in the fluid sample to rise to the top of the fluid sample. The plunger 80 of the sampling syringe 66 is axially displaced a distance along the reservoir 82 from the rear end 78 toward the front end 76 of the syringe body 74, as shown in FIG. 2A . Movement of the plunger 80 within the reservoir 82 causes at least a portion of the gaseous portion (i.e., gas bubbles) of the fluid sample 32 to be expelled from the reservoir 82, pass through the filter element 16, and enter the internal chamber 26 of the device 10 via the inlet opening 28 and the clot catcher 33. The gaseous portion of the fluid sample 32 passes through the filter element 16 and is then ultimately expelled from the internal chamber 26 of the device 10. Once at least a portion of the gaseous portion of the fluid sample 32 is displaced from the reservoir 82, the plunger 80 experiences an initial resistance force.

[0048] When sufficient force is applied to overcome the initial resistance, the plunger 80 advances further within the reservoir 82 toward the front end 76 of the syringe body 74, as shown in FIG. 2B, thereby increasing the internal pressure of the reservoir 82. The increased internal pressure of the reservoir 82 generates sufficient force to expel at least a portion of the liquid portion of the fluid sample 32 from the reservoir 82 and into the internal chamber 26 of the barrel 12 through the inlet opening 28 and the clot catcher 33. The fluid sample 32 entering the internal chamber 26 can displace the filter member 16 axially along the internal chamber 26 toward the second end 20 of the barrel 12, as shown in FIGS. 2B and 3B. The filter member 16 can be displaced so that it is positioned adjacent to the outlet opening 30. This positioning prevents ambient air from entering the internal chamber 26 and prevents the fluid sample 32 from exiting the internal chamber 26 through the outlet opening 30. In some embodiments, plunger 80 extends partially into reservoir 82 such that less than all of fluid sample 32 is transferred from reservoir 82 into internal chamber 26 .

[0049] Once the liquid portion of the fluid sample 32 has been expelled from the reservoir 82 and is contained within the internal chamber 26 of the device 10, a sample probe 72 of the liquid sample analyzer 68 can extend from the sample input port 70, pass through the filter member 16, and withdraw the liquid portion of the fluid sample 32 from the inlet side 44 of the internal chamber 26, as shown in Figures 2C and 3C. In one embodiment, the sample probe 72 pierces the gas-permeable, liquid-impermeable membrane 48 of the filter member 16 to gain fluid access to the inlet side 44 of the internal chamber 26.

[0050] After the user initially inserts the device 10 into the sample entry port 70, no further assistance is required as the fluid sample is drawn into the liquid sample analyzer 68. To allow hands-free operation without additional support structures to hold the coupled elements together in proper alignment, the connections between the collection syringe 66, the device 10, and the liquid sample analyzer 68 are sufficiently rigid so that gravity does not cause the coupling elements to tip downward or place undue stress on the combined coupled elements. In one non-limiting embodiment, as shown in FIGS. 1 and 2C , the connections between the collection syringe 66, the device 10, and the liquid sample analyzer 68 are sufficiently rigid to support the collection syringe 66 and the device 10 in axially aligned relationship with the sample probe 72 of the liquid sample analyzer 68. Therefore, the user does not need to remain in front of the liquid sample analyzer 68 and hold the device 10 and / or the collection syringe 66 while the fluid sample within the device 10 is drawn into the liquid sample analyzer 68 by the sample probe 72.

[0051] 9-11, there is shown another exemplary embodiment of an apparatus 100 constructed in accordance with the inventive concepts disclosed and claimed herein. Apparatus 100 is similar to apparatus 10 described above, except as described below. Apparatus 100 includes a barrel 112 and a nozzle cap 114. Apparatus 100 is shown without a filter member 16, which is optional.

[0052] The barrel 112 includes a first end 118, a second end 120, a sidewall 122, and an interior surface 124. The barrel 112 may be of any suitable size and shape and may be formed of any suitable material, such as, but not limited to, plastics such as polycarbonate, polystyrene, polyacrylate, and polyurethane, or medical-grade polymers. The sidewall 122 of the barrel 112 extends between the first end 118 and the second end 120 of the barrel 112. The interior surface 124 of the barrel 112 defines an interior chamber 126. The first end 118 has an inlet opening 128, and the second end 120 has an outlet opening 130.

[0053] The internal chamber 126 may be of any suitable size and shape to accommodate a fluid sample 32 (e.g., the fluid sample shown in Figures 2A-2C). The fluid sample may be, for example, blood, serum, plasma, or other bodily fluids. The fluid sample may include a gas portion and a liquid portion. The gas portion of the fluid sample may be, for example, air or other gas. Some of the gas portion may form bubbles in the fluid sample.

[0054] The inlet opening 128 and the outlet opening 130 can have any suitable geometric cross-section, including, but not limited to, circular, oval, square, or rectangular. The inlet opening 128 and the outlet opening 130 are molded, machined, or otherwise prefabricated into the barrel 112. The inlet opening 128 is shaped to capture thrombus as the fluid sample 32 is passed through the inlet opening 128 and into the internal chamber 126. The barrel 112 can include a thrombus catcher 133 positioned across the inlet opening 128 to define a plurality of apertures 135 sized and shaped to allow fluid to enter the internal chamber 126 but to capture solids (i.e., thrombus) above a predetermined size and prevent them from passing into the internal chamber 126. Solid objects that are captured by thrombus catcher 133 and prevented from entering internal chamber 126 include, for example, thrombus and other solid objects present in fluid sample 32 having a predetermined size of at least about 0.17±0.05 mm in diameter or larger. In one non-limiting embodiment, thrombus catcher 133 is star-shaped (e.g., as illustrated in FIGS. 10C and 10D as thrombus catcher 133) so as to cooperate with inlet opening 128 to define five apertures 135 (only one of which is numbered in FIGS. 10C and 10D) through which fluid enters internal chamber 126. In this non-limiting embodiment, five apertures 135 are formed between the five arms of the star-shaped thrombus catcher 133, and the size and shape of the arms can function as capture elements (e.g., as shown in FIG. 10C as thrombus catcher 133 with apertures 135) to capture thrombus and prevent it from entering the internal chamber 126.

[0055] The outlet opening 130 may include a nozzle cap 114. The nozzle cap 114 includes a cap portion 136 and a tubular portion 138 having a bore 140 extending therethrough. The tubular portion 138 may be in the form of a male luer that frictionally engages the sample input port 70 (FIG. 1) of the liquid sample analyzer 68 to allow for "hands-free" operation of the liquid sample analyzer 68, such that a fluid sample within the device 100 is drawn into the liquid sample analyzer 68 without the user having to hold the device 100.

[0056] The bore 140 can have a cross-section of any suitable geometry, including, but not limited to, circular, oval, square, or rectangular. The bore 140 is sized to have a diameter adapted to axially and slidably receive the sample probe 72. The base of the tubular portion 138 flares outward and merges with the cap portion 136. The nozzle cap 114 is suitably coupled to the second end of the barrel 112 such that the bore 140 is aligned with the outlet opening 130 to enable fluid communication with the interior chamber 126.

[0057] A gas-permeable, liquid-impermeable membrane 149 (FIG. 10A) is secured to the barrel 112 adjacent the second end 120 of the barrel 112 and provides a fluid-tight seal across the exit opening 130 to prevent the liquid portion of the fluid sample from passing from the internal chamber 126 to the exit opening 130. The gas-permeable, liquid-impermeable membrane 149 is pierceable so that the sample probe 72 can pass through the gas-permeable, liquid-impermeable membrane 149 and withdraw the liquid portion of the fluid sample from the internal chamber 126.

[0058] The gas-permeable, liquid-impermeable membrane 149 may be formed from any suitable material, such as, but not limited to, polytetrafluoroethylene, polyvinylidene fluoride, polyvinyl chloride, polyolefins such as polypropylene, polyethylene, polymethylpentene, polyamide, polysulfone, polyetheretherketone, polycarbonate, and combinations including any of the foregoing. In one embodiment, the gas-permeable, liquid-impermeable membrane 149 is formed from a material including at least one of polytetrafluoroethylene, polypropylene, and polyethylene. The gas-permeable, liquid-impermeable membrane 149 may have a thickness suitable to allow puncture when a mechanical force is applied.

[0059] Like device 10 , device 100 can be used in conjunction with a collection syringe 66 and a liquid sample analyzer 68 .

[0060] To establish fluid communication between the collection syringe 66 and the device 100, the collection syringe 66, containing the volume of fluid sample in the reservoir 82, can be matingly engaged with the first end 118 of the barrel 112. As shown in FIG. 11 , the front end 76 of the syringe body 74 is matingly engaged with the device 100 via a threaded engagement 79. As shown in FIGS. 9 and 10B , the barrel 112 can include a barrel coupling 194. In one embodiment, the threaded engagement 79 of the syringe body 74 is a male luer connector, and the barrel coupling 194, in one exemplary embodiment, is a female luer connector including a pair of threaded lugs 195 extending radially from the exterior of the barrel 112 and having a thread pitch, size, and geometry corresponding to the threaded engagement 79 of the syringe body 74. 11 , the thread engagement portion 79 can interlockingly engage the barrel connection portion 194 to prevent significant relative movement between the collection syringe 66 and the device 100, allowing for "hands-free" operation of the liquid sample analyzer 68 such that a fluid sample from within the collection syringe 66 is drawn through the device 100 and into the liquid sample analyzer 68 without the user having to hold the collection syringe 66 or the device 100. It will be appreciated that other suitable connectors, such as a luer slip connection, may be utilized between the collection syringe 66 and the device 100. The first end 118 of the barrel 112 can include a female luer 196 ( FIG. 10A ).

[0061] 12-15, device 100 can further include a chromatographic assay assembly 200 for detecting free hemoglobin in a fluid sample, such as fluid sample 32. Chromatographic assay assembly 200 is housed within chromatographic assay chamber 211 (FIGS. 12 and 14) of barrel 112. In one non-limiting embodiment, chromatographic assay chamber 211 is formed in part by a portion of the exterior surface of sidewall 122 of barrel 112 and cover 212. Chamber 211 is in fluid communication with interior chamber 126 of barrel 112 via passage 210 downstream of clot catcher 133 and upstream of membrane 149, as shown in FIG. 14. Chromatographic assay chamber 211 is configured to hold chromatographic assay assembly 200 such that at least a portion of the fluid sample in interior chamber 126 of barrel 112 enters chromatographic assay chamber 211 and contacts chromatographic assay assembly 200.

[0062] The cover 212 may be formed, in whole or in part, from the same material as the barrel 112. For example, the cover 212 may be formed from any suitable material, including, but not limited to, plastics such as polycarbonate, polystyrene, polyacrylate, and polyurethane, or medical-grade polymers. The cover 212 may be transparent or may be formed with a transparent window for viewing the chromatographic assay assembly 200. As described below, the cover 212 may include a fill frame 212a for observing entry of a sufficient amount of fluid sample 32 into the chamber 211 and a read frame 212b for assessing the level of hemolysis, as shown in FIGS. 12 and 14. In one non-limiting embodiment, the fill frame 212a and the read frame 212b are contoured from the remainder of the cover 212 by reducing the thickness of the cover 212 to define the fill frame 212a and the read frame 212b. In another embodiment, the filler frame 212a and the reading frame 212b are formed of a transparent material, such as glass, that is different from the material used to form the cover 212. In another embodiment, the filler frame 212a and the reading frame 212b can be voids or openings that extend through the cover 212.

[0063] 13A, 13B, and 14, the chromatographic assay assembly 200 includes a sample application pad 214 in fluid contact with a chromatographic detection pad 216. The sample application pad 214 is configured to apply a portion of the fluid sample 32 to the chromatographic assay assembly 200. The sample application pad 214 receives and absorbs (a portion of) the fluid sample 32, after which the fluid sample 32 from the internal chamber 126 via the passageway 210 is absorbed from the sample application pad 214 into the chromatographic detection pad 216.

[0064] Referring to FIG. 13A, the sample application pad 214 is formed from two layers of different sizes and dimensions that do not completely overlap each other. The sample application pad 214 includes a first layer 230 formed from a pre-filtration material, such as a glass fiber material, and a second layer 232 made of a different filtration material, such as an asymmetric polysulfone material. The first layer 230 has a first end 240, a second end 242, an upper surface 244, and a lower surface 246. The second layer 232 has a first end 247, a second end 249, an upper surface 252, and a lower surface 254. At least a portion of the first layer 230 adjacent to the second end 242 overlaps a portion of the second layer 232 between the first end 247 and the second end 249. The overlapping portions of the first layer 230 and the second layer 232 may be attached to one another, or the overlapping portion of the first layer 230 may simply be placed on top of the second layer 232 such that a portion of the lower surface 246 of the first layer 230 contacts a portion of the upper surface 252 of the second layer 232.

[0065] The lower surface 246 of the first layer 230 is aligned with and in fluid communication with the passageway 210 and is positioned to receive the fluid sample 32 from the interior chamber 126 of the barrel 112 .

[0066] Thus, the first layer 230 and the second layer 232 of the sample application pad 214 can partially overlap each other to form overlapping and non-overlapping portions. Referring to the workflow of the chromatographic assay assembly 200 shown in FIG. 13B , the non-overlapping portion (at the lower surface 246) of the first layer 230 can receive and absorb a portion of the fluid sample 32 from the internal chamber 126 via the passageway 210 (shown in the second panel of FIG. 13B ). The fluid sample 32 is then absorbed from the overlapping portion of the sample application pad 214 into the chromatographic detection pad 216 (shown in the third and fourth panels of FIG. 13B ). In particular, once the fluid sample 32 has absorbed or impregnated the entire first layer 230 (which may be visible through the filler frame 212a shown in FIG. 12), the fluid sample 32 is filtered or passed from the overlapping portion of the first layer 230 (at the lower surface 246) to the overlapping portion of the second layer 232 (at the upper surface 252), as shown in the third panel of FIG. 13B. Once the fluid sample 32 has absorbed or impregnated the entire second layer 232, the fluid sample 32 is filtered or passed from the second layer 232 (at the lower surface 254) to the sample application site 248 of the chromatographic detection pad 216 (the portion of its upper surface that overlaps the lower surface 254 of the second layer 232), as shown in the third and fourth panels of FIG. 13B. The components of the fluid sample 32 absorbed by the chromatographic detection pad 216 (i.e., plasma and free hemoglobin, if present) then flow by capillary action from the sample application site 248 to the detection site 250 of the chromatographic detection pad 216 for detection of free hemoglobin, which indicates hemolysis (shown in the fourth panel).

[0067] Because the sample application pad 214 is permeable to the plasma and free hemoglobin present in the fluid sample 32 but not to the red blood cells, the red blood cells present in the fluid sample 32 are retained within the two layers 230 and 232 of the sample application pad 214, thereby preventing them from flowing therethrough to the chromatographic detection pad 216. Thus, the sample application pad 214 functions as a filter to filter the fluid sample 32 received through the passageway 210, such that the red blood cells present in the fluid sample 32 (received from the internal chamber 126 via the passageway 210) are filtered out and retained within the two layers 230 and 232, while the plasma and free hemoglobin present in the fluid sample 32 pass through the pores of the sample application pad 214 and are received by and absorbed into the chromatographic detection pad 216.

[0068] The multi-layer or bi-layer sample application pad 214 advantageously provides improved removal or filtration of red blood cells and detection of hemolysis (by detecting the presence of free hemoglobin at the chromatographic detection pad 216) because the first layer 230 of the sample application pad 214 can retain at least a portion of the red blood cells and other large cellular components in the fluid sample 32 (without lysing the cells), thereby reducing the amount of red blood cells and other large cellular components that enter the second layer 232 of the sample application pad 214 so as not to overburden the filtration performed in the second layer 232. In particular, but not by way of limitation, the first layer 230 and / or the second layer 232 have various pore sizes that decrease in size as they move from the first layer 230 to the lower surface 254 of the second layer 232 (i.e., as they move in a direction toward the chromatographic detection pad).

[0069] The chromatographic detection pad 216 defines a path for capillary fluid flow. Components of the fluid sample 32 that are able to flow through the sample application pad 214 then flow through the chromatographic detection pad 216 by capillary action (also referred to as capillary flow). The chromatographic detection pad 216 has a first end and a second end. The chromatographic detection pad 216 is made of any suitable material that allows plasma and free hemoglobin from the fluid sample 32 to flow freely therethrough by capillary action. As a non-limiting example, the chromatographic detection pad 216 may be a nitrocellulose membrane. The chromatographic detection pad 216 may have pores through which specific components of the fluid sample 32 migrate by capillary action. Most of the pores in the chromatographic detection pad 216 may all be substantially the same size or may fall within a range of values.

[0070] 13A, a first end of the chromatographic detection pad 216 is in fluid contact with the lower surface 254 of the second layer 232 of the sample application pad 214, forming a sample application site 248 in the chromatographic detection pad 216. As shown in FIGS. 13A-13B, the chromatographic detection pad 216 also has a detection site 250 spaced from (and, in certain non-limiting embodiments, downstream of) the first end portion / sample application site 248, which detection site 250 is located between the first and second end portions, or is substantially adjacent to or closer to the second end portion than the first end portion.

[0071] The sample application pad 214 covers only the first end portion of the chromatographic detection pad 216 adjacent to its sample application site 248, but not its detection site 250; in this way, the flow of sample through the chromatographic detection pad 216 and into its detection site 250 is visible through the reading frame 212b of the cover 212 (as shown in Figures 12 and 14).

[0072] Referring to FIG. 13A, the chromatographic assay assembly 200 may further include a backing material 218 to which the underside of the chromatographic detection pad 216 is attached or otherwise associated (for example, but not limited to, by double stick adhesive).

[0073] When a fluid sample 32 (such as, but not limited to, a whole blood sample, urine, or other red blood cell-containing liquid sample) is applied to the chromatographic assay assembly 200, free hemoglobin flows through the sample application pad 214 into the chromatographic detection pad 216 and then from the sample application region 248 of the chromatographic detection pad 216 into its detection region 250. In this manner, free hemoglobin (indicative of hemolysis) is detectable at the detection region 250 by a color change due to the red color of the free hemoglobin. The chromatographic detection pad 216 is formed of a white material, thus allowing a visual readout or detection of hemolysis by a color change of the chromatographic detection pad 216 at the detection region 250 through the reading frame 212b of the cover 212.

[0074] While one particular, non-limiting embodiment of a chromatographic assay assembly 200 is shown in Figures 13A and 13B, it will be understood that the design and configuration of the illustrated chromatographic assay assembly 200 is for illustrative purposes only. The scope of the present disclosure includes adapting the design and configuration of the chromatographic assay assembly of the present disclosure so long as the chromatographic assay assembly remains operable in accordance with the present disclosure.

[0075] For example (and not by way of limitation), it will be understood that the first layer 230 (of pre-filtration material) and the second layer 232 (of asymmetric polysulfone material) of the sample application pad 214 need not be symmetrical to one another (i.e., they can differ from one another in size, length, width, and / or thickness). In addition, the first layer 230 and the second layer 232 of the sample application pad 214 need not match one another; thus, each layer can have areas that do not overlap with the other. The only requirement is that at least a portion of the first layer 230 overlap a sufficient portion of the second layer 232 so that sample flows through the first layer 230 into the second layer 232 and then from the second layer 232 into the sample application site 248 of the chromatographic detection pad 216.

[0076] In use, the collection syringe 66 is interlockingly engaged with the device 100, and the two are positioned in an upright orientation with the device 100 above the collection syringe 66. If the device 100 does not include a filter member 16, the user may remove air bubbles from the fluid sample using conventional methods as described above. The plunger 80 of the collection syringe 66 is axially displaced a distance along the reservoir 82 from the rear end 78 toward the front end 76 of the syringe body 74. Movement of the plunger 80 within the reservoir 82 expels at least a portion of the fluid sample from the reservoir 82 through the inlet opening 128 and the clot catcher 133 into the interior chamber 126 of the device 100. Any gaseous portion of the fluid sample passes through the gas-permeable, liquid-impermeable membrane 149.

[0077] A portion of the fluid sample enters the chromatographic assay chamber 211 through the passageway 210 and contacts the sample application pad 214. FIG. 13B illustrates the workflow of the chromatographic assay assembly 200. A fluid sample 32 (e.g., a blood sample) is applied to the underside 246 of the first layer 230 of the sample application pad 214, as shown in the second panel of FIG. 13B, and enters the first layer 230. The fluid sample 32 impregnates the first layer 230 and flows through the overlapping portion to the second layer 232 (third panel). The impregnation of the first layer 230 is determined by viewing the first layer 230 through the filler frame 212a of the cover 212, which is aligned with at least a portion of the sample application pad 214.

[0078] Once the first layer 230 is saturated, plasma and free hemoglobin (if any) from the blood sample 32 then passes through the second layer 232 and enters the chromatographic detection pad 216, flowing from the sample application site 248 to its detection site 250 for detection of any hemolysis present (fourth panel). A control line may be present at the detection site 250 or at the chromatographic detection pad 216 near the detection site 250. In one non-limiting embodiment, plasma reaching the detection site 250 turns the control line from yellow to blue, indicating that the chromatographic assay assembly 200 is ready to be read through the reading frame 212b aligned with the detection site 250.

[0079] 15 illustrates one non-limiting embodiment of a reference device 260 that can be utilized with the chromatographic assay assembly 200 to visually determine the level of hemolysis in the fluid sample 32. The reference device 260 includes multiple reference colors (such as, but not limited to, reference colors 262, 264, 266, 268, and 270, where color 262 has the white / default color of the chromatographic detection pad 16 and serves as a negative control, and colors 264, 266, 268, and 270 are various shades of pink / red of increasing intensity / hue, with darker intensity / hue correlating to a greater amount / degree of hemolysis; five reference colors are shown for illustrative purposes only). Additionally, the reference device 260 also includes a key 272 that associates each of the reference colors 262, 264, 266, 268, and 270 with a particular concentration of free hemoglobin. That is, (by way of example only), color 262 of key 272 is a negative control, while color 264 indicates the presence of 0 mg / dL of free hemoglobin, color 266 indicates the presence of 100 mg / dL of free hemoglobin, color 268 indicates the presence of 250 mg / dL of free hemoglobin, and color 270 indicates the presence of 500 mg / dL of free hemoglobin. In this manner, by comparing the color of detection site 250 to reference colors 264-270 of reference device 260, an individual can determine the level of hemolysis in a liquid biological sample in any environment, including, but not limited to, a simple rapid test or a home environment.

[0080] The design and configuration of reference device 260 in FIG. 15 are shown for illustrative purposes only; it will be understood that reference device 260 may have fewer than five reference colors or more than five reference colors (such as, but not limited to, two, three, four, five, six, seven, eight, nine, ten, or more reference colors). In addition, the shapes and arrangements of the reference colors may vary. Also, keys 272 may be provided in shapes / arrangements different from those shown in FIG. 15. The design and configuration of each component of reference device 260 (such as, but not limited to, the reference colors and keys 272) is readily adapted by one skilled in the art to have any design and configuration that enables reference device 260 to function in accordance with the present disclosure. Alternatively, a medical diagnostic device may be utilized to optically detect the level of hemolysis in a fluid sample, such as optically detecting the level of hemolysis through read frame 212b, in which case the medical diagnostic device includes a light sensor, a processor, and a light source directed toward detection site 250. The medical diagnostic device may be a liquid sample analyzer 68 or another device.

[0081] A method for optically testing a fluid sample for hemolysis may include measuring characteristics of light reflected by the detection site 250 of the chromatographic assay assembly 200, as described above, after a portion of the liquid sample 32 is applied to the sample application pad 214 and free hemoglobin flows through the sample application pad 214 from the sample application site 248 of the chromatographic detection pad 216 to the detection site 250. The measured amounts of, e.g., red, orange, green, and / or blue light, can then be used to determine the level of free hemoglobin, e.g., by comparing the measured amounts to one or more reference values. In exemplary embodiments, the method for testing a fluid sample for hemolysis is performed optically by a medical diagnostic device (not shown) or visually by a healthcare provider. The healthcare provider can, for example, visually compare the completed chromatographic assay assembly 200 to a reference device (such as, but not limited to, the reference device 260 shown in FIG. 15 ), which includes multiple reference colors each corresponding to a different level of hemolysis, to visually determine hemolysis of the liquid sample 32.

[0082] This method can detect levels of hemoglobin that exceed a predetermined interference value (e.g., manufacturer's interference level). If the sample exceeds the interference value, the sample is flagged to notify the end user (i.e., relevant healthcare provider) that the sample is compromised due to hemolysis and should not be used for further testing.

[0083] If the determined level of hemolysis in the sample (by visual and / or optical detection of free hemoglobin levels as described above) is below a predetermined threshold, the sample is intact and may be subjected to further testing. To further test an intact sample, the device 100, with the collection syringe 66 engaged with the device 100, is engaged with a testing instrument, such as a liquid sample analyzer 68. The sample probe 72 (FIG. 3C) of the liquid sample analyzer 68 can then be extended from the sample entry port 70 and passed through the gas-permeable, liquid-impermeable membrane 149 to allow the user to withdraw the liquid portion of the fluid sample from the internal chamber 126 in a "hands-free" manner, without having to hold the collection syringe 66 or the device 100.

[0084] After the user initially inserts the device 100 into the sample entry port 70, no further assistance is required as the fluid sample is drawn into the liquid sample analyzer 68. To allow for hands-free operation without additional support structures to hold the coupled elements together in proper alignment, the connections between the collection syringe 66, device 100, and liquid sample analyzer 68 are sufficiently rigid so that gravity does not cause them to tip downward or place undue stress on the combination of coupled elements. Similar to that shown in FIG. 2C in connection with device 10, the connections between the collection syringe 66, device 100, and liquid sample analyzer 68 are sufficiently rigid to support the collection syringe 66 and device 100 in an axially aligned relationship with the sample probe 72 of the liquid sample analyzer 68. As such, the user does not need to remain in front of the liquid sample analyzer 68 and hold the device 100 and / or collection syringe 66 while the liquid sample within the device 100 is drawn into the liquid sample analyzer 68 by the sample probe 72.

[0085] From the foregoing description, it will be apparent that the inventive concepts disclosed herein are well adapted to carry out the objects and attain the advantages set forth herein, as well as those inherent in the inventive concepts disclosed herein. While exemplary embodiments of the inventive concepts disclosed herein have been set forth for purposes of this disclosure, it will be understood that numerous modifications may be made which will readily suggest themselves to those skilled in the art and which can be effected without departing from the scope of the inventive concepts as disclosed herein and defined by the appended claims.

[0086] The following is a list of non-limiting exemplary embodiments of the inventive concepts disclosed herein.

[0087] Exemplary Embodiment 1. An exemplary device for transferring a fluid sample having a liquid portion and a gas portion from a fluid sampling device to a liquid sample analyzer, comprising: a barrel having a first end having an inlet opening across which a clot catcher extends upstream of the passageway, a second end opposite the first end having an outlet opening, a sidewall extending between the first end and the second end, an inner surface defining an interior chamber, and an outer surface defining at least a portion of a chromatographic assay chamber in fluid communication with the interior chamber via a passageway through the outer surface of the barrel; a chromatographic assay assembly contained in the chromatographic assay chamber and configured to detect the presence of free hemoglobin in the fluid sample; The chromatographic assay assembly includes: a sample application pad configured to receive the fluid sample from the interior chamber, the sample application pad being formed from a first layer of a pre-filtration material and a second layer of an asymmetric polysulfone material, the sample application pad being permeable to plasma and free hemoglobin but not to red blood cells; a chromatographic detection pad in fluid contact with the sample application pad and configured to detect the presence of free hemoglobin; 1. An apparatus comprising:

[0088] Exemplary Embodiment 2. The exemplary device of Exemplary Embodiment 1, wherein the chromatographic assay chamber is defined by a portion of the exterior surface of the barrel and a cover, the cover having a transparent fill frame aligned with the sample application pad for viewing the flow of fluid sample through the sample application pad, and a transparent read frame aligned with the detection sites for viewing the detection sites of the chromatographic detection pad.

[0089] Exemplary Embodiment 3. The exemplary device of Exemplary Embodiment 1 or 2, wherein a first end of the barrel has a barrel coupling portion engageable with a portion of the fluid sample collection device and a second end of the barrel has a tubular portion configured to engage with the liquid sample analyzer, such that the combination of the fluid sample collection device and barrel is attachable to the liquid sample analyzer without further support.

[0090] Exemplary Embodiment 4. The exemplary device of any one of Exemplary Embodiments 1-3, wherein the barrel coupling includes at least one threaded lug extending radially outward from the sidewall of the barrel for interlocking engagement with a portion of the fluid sampling device.

[0091] Exemplary Embodiment 5. The exemplary device of any one of Exemplary Embodiments 1-4, wherein the barrel coupling includes a pair of threaded lugs extending radially outward from the sidewall of the barrel for interlocking engagement with the fluid sampling device.

[0092] Exemplary Embodiment 6. The exemplary device of any one of Exemplary Embodiments 1-5, wherein the barrel connection is a female luer connector.

[0093] Exemplary Embodiment 7. The exemplary device of any one of Exemplary Embodiments 1-6, wherein the tubular portion of the barrel is a male luer connector configured to engage with a liquid sample analyzer.

[0094] Exemplary Embodiment 8. The exemplary apparatus of any one of Exemplary Embodiments 1-7, further comprising a gas-permeable, liquid-impermeable membrane secured to the barrel adjacent the second end of the barrel, the gas-permeable, liquid-impermeable membrane being pierceable such that a sample probe is configured to pass through the gas-permeable, liquid-impermeable membrane into the interior chamber.

[0095] Exemplary Embodiment 9. The exemplary device of any one of Exemplary Embodiments 1-8, wherein the gas-permeable, liquid-impermeable membrane is formed from a material comprising at least one of polytetrafluoroethylene, polypropylene, and polyethylene.

[0096] Exemplary embodiment 10. A filter member defining an inlet side and an outlet side of the internal chamber and positioned within the internal chamber so as to be positionable between the first end and the second end of the barrel, the filter member having at least one gas-permeable, liquid-impermeable membrane configured to separate at least a portion of the gas portion of the fluid sample from a liquid portion of the fluid sample by allowing at least a portion of the gas portion of the fluid sample to pass through the filter member from the inlet side to the outlet side of the internal chamber, and to provide a fluid-tight seal across the filter member to prevent a liquid portion of the fluid sample from passing from the inlet side to the outlet side when the fluid sample enters the internal chamber through the inlet opening; An exemplary device described in any one of exemplary embodiments 1-9, wherein the filter member is perforable so that a probe is passed through the filter member from the outlet side to the inlet side and a liquid portion of the fluid sample is drawn from the inlet side of the internal chamber.

[0097] Exemplary Embodiment 11. The exemplary combination of any one of Exemplary Embodiments 1-10, wherein the filter member is slidably disposed within the interior chamber of the barrel.

[0098] Exemplary embodiment 12. The device of any one of exemplary embodiments 1-11; a reference device containing multiple reference colors, each corresponding to a different level of hemolysis; An exemplary kit comprising:

[0099] Exemplary Embodiment 13. An exemplary method of transferring a fluid sample having a liquid portion and a gas portion from a fluid sampling device to a liquid sample analyzer having a sample probe, comprising: obtaining a device having a barrel having a first end with an inlet opening with a thrombus catcher extending across the inlet opening, a second end with an outlet opening, a sidewall extending between the first end and the second end, and an interior surface defining an interior chamber; transferring at least a portion of the fluid sample from the fluid sample collection device through the inlet opening to the interior chamber of the barrel such that the fluid sample passes through a clot catcher at the inlet opening to capture solids in the fluid sample; passing a portion of the fluid sample from the interior chamber of the barrel to a chromatographic assay chamber and a chromatographic assay assembly housed in the chromatographic assay chamber in fluid communication with the interior chamber downstream of the clot catcher; detecting the presence of free hemoglobin in the fluid sample with a chromatographic assay assembly; transferring the fluid sample from the internal chamber to a liquid sample analyzer using the sample probe; An exemplary method comprising:

[0100] Exemplary embodiment 14. The detecting step comprises: applying the fluid sample to a sample application pad of a chromatographic assay assembly, and allowing plasma and free hemoglobin present in the fluid sample to flow through the sample application pad to a chromatographic detection pad while retaining red blood cells present in the fluid sample on the sample application pad; allowing the plasma and free hemoglobin to flow by capillary action from the sample application site of the chromatographic detection pad to the detection site of the chromatographic detection pad; visually comparing the color change at the detection site to a reference device containing multiple reference colors, each corresponding to a different level of hemolysis; An exemplary method comprising:

[0101] Exemplary Embodiment 15. The exemplary method of any one of Exemplary Embodiments 1-14, wherein the sample application pad comprises a first layer and a second layer, and the applying step further comprises impregnating the first layer with the fluid sample and passing the fluid sample from the first layer through the second layer to impregnate the second layer with the fluid sample.

[0102] Exemplary Embodiment 16. The exemplary method of any one of Exemplary Embodiments 1-15, wherein the chromatographic assay chamber is defined by a portion of the exterior surface of the barrel, a filler frame aligned with the sample application pad, and a cover having a read frame aligned with a detection site of the chromatographic detection pad, and wherein the applying step further includes viewing the sample application pad through the filler frame of the cover to determine whether the sample application pad is impregnated with the fluid sample.

[0103] Exemplary Embodiment 17. The exemplary method of any one of Exemplary Embodiments 1-16, wherein the visually comparing step comprises viewing the detection site through a reading frame on the cover.

[0104] Exemplary Embodiment 18. The exemplary method of any one of Exemplary Embodiments 1-17, wherein transferring at least a portion of the fluid sample from the fluid sample collection device further comprises engaging a first end of the barrel with a portion of the fluid sample collection device, and transferring the fluid sample from the internal chamber to the liquid sample analyzer further comprises engaging a second end of the barrel with the liquid sample analyzer such that the combination of the fluid sample collection device and the barrel is attached to the liquid sample analyzer without further support.

[0105] Exemplary Embodiment 19. The exemplary method of any one of Exemplary Embodiments 1-18, wherein the detection of hemolysis in the visual comparison step is determined to be below a predetermined threshold of hemolysis prior to transferring the fluid sample from the internal chamber to the liquid sample analyzer.

[0106] Exemplary Embodiment 20. The exemplary method of any one of Exemplary Embodiments 1-19, wherein the step of engaging the first end further includes threading the first end of the barrel to a portion of the fluid sample-collecting device to interlockingly engage the barrel with the fluid sample-collecting device.

[0107] Exemplary Embodiment 21. The exemplary method of any one of Exemplary Embodiments 1-20, wherein the first end of the barrel has a barrel connection that is a male luer connector and the portion of the fluid sample collection device has a female luer connector, and wherein the step of engaging the first end further comprises engaging the male luer connector of the barrel with the female luer connector of the fluid sample collection device.

[0108] Exemplary Embodiment 22. The exemplary method of any one of Exemplary Embodiments 1-21, wherein the second end of the barrel has a tubular portion that is a male luer connector, and wherein engaging the second end includes engaging the male luer connector of the barrel into a sample entry port of the liquid sample analyzer.

[0109] Exemplary Embodiment 23. The exemplary method of any one of Exemplary Embodiments 1-22, wherein the steps of engaging the first end and engaging the second end further include axially aligning the fluid sample collection device and barrel with the sample probe.

[0110] Exemplary Embodiment 24. The exemplary method of any one of Exemplary Embodiments 1-23, wherein the apparatus further includes a gas-permeable, liquid-impermeable membrane secured to the barrel adjacent the second end of the barrel, and wherein transferring the fluid sample from the interior chamber of the barrel further includes passing a sample probe through the gas-permeable, liquid-impermeable membrane and into the interior chamber of the barrel.

[0111] Exemplary Embodiment 25. Contacting the fluid sample with a filter member disposed within the interior chamber and defining an inlet side and an outlet side of the interior chamber, the filter member having a gas-permeable, liquid-impermeable membrane; separating at least a portion of the gaseous portion of the fluid sample from a liquid portion of the fluid sample by contacting the fluid sample with a gas-permeable, liquid-impermeable membrane such that at least a portion of the gaseous portion of the fluid sample passes across the filter member from the inlet side to the outlet side of the internal chamber while preventing a liquid portion of the fluid sample from passing from the inlet side to the outlet side; collecting at least a portion of the liquid portion of the fluid sample from the inlet side of the internal chamber; 25. The exemplary method of any one of Exemplary Embodiments 1-24, further comprising:

[0112] Exemplary Embodiment 26. The exemplary method of any one of Exemplary Embodiments 1-25, wherein withdrawing a fluid sample from the interior chamber of the barrel further comprises passing a sample probe through the gas-permeable, liquid-impermeable membrane to the inlet side of the interior chamber of the barrel.

Claims

1. 1. An apparatus for transferring a fluid sample having a liquid portion and a gas portion from a fluid sampling device to a liquid sample analyzer, comprising: a barrel having a first end having an inlet opening across which a thrombus catcher extends upstream of the passageway, a second end opposite the first end having an outlet opening, a sidewall extending between the first end and the second end, an inner surface defining an interior chamber, and an outer surface defining at least a portion of a chromatographic assay chamber in fluid communication with the interior chamber via a passageway through the outer surface of the barrel; a chromatographic assay assembly housed in the chromatographic assay chamber and configured to detect the presence of free hemoglobin in the fluid sample; the chromatographic assay assembly comprising: a sample application pad configured to receive the fluid sample from the interior chamber, the sample application pad being formed from a first layer of pre-filtration material and a second layer of asymmetric polysulfone material, the sample application pad being permeable to plasma and free hemoglobin but not to red blood cells; a chromatographic detection pad in fluid contact with the sample application pad and configured to detect the presence of free hemoglobin; Including, The chromatographic assay chamber is defined by a portion of the exterior surface of the barrel and a cover, the cover having a transparent fill frame aligned with the sample application pad for viewing the flow of the fluid sample through the sample application pad, and a transparent read frame aligned with the detection site for viewing the detection site of the chromatographic detection pad. The device.

2. 10. The device of claim 1, wherein a first end of the barrel has a barrel coupling portion engageable with a portion of the fluid sample collection device and a second end of the barrel has a tubular portion configured to engage with the liquid sample analyzer, such that the combination of the fluid sample collection device and barrel is attachable to the liquid sample analyzer without further support.

3. 3. The device of claim 2, wherein the barrel coupling includes at least one threaded lug extending radially outward from the sidewall of the barrel for interlocking engagement with a portion of the fluid sampling device.

4. 3. The device of claim 2, wherein the barrel connection includes a pair of threaded lugs extending radially outward from the sidewall of the barrel for interlocking engagement with the fluid sampling device.

5. 3. The device of claim 2, wherein the barrel connection is a female luer connector.

6. 3. The device of claim 2, wherein the tubular portion of the barrel is a male luer connector configured to engage with a liquid sample analyzer.

7. 10. The apparatus of claim 1, further comprising a gas-permeable, liquid-impermeable membrane secured to the barrel adjacent the second end of the barrel, the gas-permeable, liquid-impermeable membrane being pierceable such that the sample probe is configured to pass through the gas-permeable, liquid-impermeable membrane into the interior chamber.

8. 8. The device of claim 7, wherein the gas-permeable, liquid-impermeable membrane is formed from a material comprising at least one of polytetrafluoroethylene, polypropylene, and polyethylene.

9. further comprising a filter member positioned within the internal chamber so as to define an inlet side and an outlet side of the internal chamber and be positionable between the first end and the second end of the barrel, the filter member having at least one gas-permeable, liquid-impermeable membrane configured to separate at least a portion of the gas portion of the fluid sample from a liquid portion of the fluid sample by allowing at least a portion of the gas portion of the fluid sample to pass through the filter member from the inlet side to the outlet side of the internal chamber and to provide a fluid-tight seal across the filter member to prevent a liquid portion of the fluid sample from passing from the inlet side to the outlet side when the fluid sample enters the internal chamber through the inlet opening; 10. The device of claim 1, wherein the filter member is pierceable such that the probe is passed through the filter member from the outlet side to the inlet side, drawing a liquid portion of the fluid sample from the inlet side of the internal chamber.

10. 10. The device of claim 9, wherein the filter member is slidably disposed within the interior chamber of the barrel.

11. The device of claim 1; a reference device containing multiple reference colors, each corresponding to a different level of hemolysis; Kit including:

12. 1. A method for transferring a fluid sample having a liquid portion and a gas portion from a fluid sampling device to a liquid sample analyzer having a sample probe, comprising: obtaining a device having a barrel having a first end having an entrance opening with a thrombus catcher extending across the entrance opening, a second end having an exit opening, a sidewall extending between the first end and the second end, and an interior surface defining an interior chamber; transferring at least a portion of the fluid sample from the fluid sample collection device through the inlet opening into the interior chamber of the barrel such that the fluid sample passes through a clot catcher at the inlet opening to capture solids in the fluid sample; passing a portion of the fluid sample from the interior chamber of the barrel to a chromatographic assay chamber and a chromatographic assay assembly housed in the chromatographic assay chamber in fluid communication with the interior chamber downstream of the clot catcher; Detect the presence of free hemoglobin in a fluid sample with a chromatographic assay assembly. and a step of releasing the transferring the fluid sample from the internal chamber to a liquid sample analyzer using the sample probe; Including, The detection process is: applying the fluid sample to a sample application pad of a chromatographic assay assembly, allowing plasma and free hemoglobin present in the fluid sample to flow through the sample application pad to a chromatographic detection pad while retaining red blood cells present in the fluid sample on the sample application pad; allowing the plasma and free hemoglobin to flow by capillary action from the sample application site of the chromatographic detection pad to the detection site of the chromatographic detection pad; visually comparing the color change at the detection site to a reference device containing multiple reference colors, each corresponding to a different level of hemolysis; Including, the chromatographic assay chamber is defined by a portion of the exterior surface of the barrel and a cover having a filler frame aligned with the sample application pad and a read frame aligned with a detection site of the chromatographic detection pad, and the applying step further includes viewing the sample application pad through the filler frame of the cover to determine whether the sample application pad is impregnated with the fluid sample; The method.

13. 13. The method of claim 12, wherein the sample application pad comprises a first layer and a second layer, and the applying step further comprises impregnating the first layer with the fluid sample and passing the fluid sample from the first layer through the second layer to impregnate the second layer with the fluid sample.

14. 13. The method of claim 12, wherein the visually comparing step comprises viewing the detection site through a reading frame on the cover.

15. 13. The method of claim 12, wherein transferring at least a portion of the fluid sample from the fluid sample collection device further comprises engaging a first end of the barrel with a portion of the fluid sample collection device, and transferring the fluid sample from the internal chamber to the liquid sample analyzer further comprises engaging a second end of the barrel with the liquid sample analyzer such that the combination of the fluid sample collection device and the barrel is attached to the liquid sample analyzer without further support.

16. 16. The method of claim 15, wherein the detection of hemolysis in the visual comparing step is determined to be below a predetermined threshold of hemolysis prior to transferring the fluid sample from the internal chamber to the liquid sample analyzer.

17. 16. The method of claim 15, wherein the step of engaging the first end further comprises threading the first end of the barrel onto a portion of the fluid-sampling device to operatively engage the barrel with the fluid-sampling device.

18. 18. The method of claim 17, wherein the first end of the barrel has a barrel connection that is a male luer connector and the portion of the fluid sample collection device has a female luer connector, and the step of engaging the first end further comprises engaging the male luer connector of the barrel with the female luer connector of the fluid sample collection device.

19. 18. The method of claim 17, wherein the second end of the barrel has a tubular portion that is a male luer connector, and the step of engaging the second end includes engaging the male luer connector of the barrel into a sample entry port of the liquid sample analyzer.

20. The steps of engaging the first end and engaging the second end include: The method of claim 15 further comprising axially aligning the sample probe.

21. 15. The method of claim 14, wherein the apparatus further comprises a gas-permeable, liquid-impermeable membrane secured to the barrel adjacent the second end of the barrel, and wherein transferring the fluid sample from the interior chamber of the barrel further comprises passing the sample probe through the gas-permeable, liquid-impermeable membrane and into the interior chamber of the barrel.

22. contacting the fluid sample with a filter member disposed within the interior chamber and defining an inlet side and an outlet side of the interior chamber, the filter member having a gas-permeable, liquid-impermeable membrane; separating at least a portion of the gaseous portion of the fluid sample from a liquid portion of the fluid sample by contacting the fluid sample with a gas-permeable, liquid-impermeable membrane such that at least a portion of the gaseous portion of the fluid sample passes across the filter member from the inlet side to the outlet side of the internal chamber while preventing a liquid portion of the fluid sample from passing from the inlet side to the outlet side; collecting at least a portion of the liquid portion of the fluid sample from the inlet side of the internal chamber; 16. The method of claim 15, further comprising:

23. 23. The method of claim 22, wherein the step of withdrawing a fluid sample from the interior chamber of the barrel further comprises passing a sample probe through the gas-permeable, liquid-impermeable membrane to the inlet side of the interior chamber of the barrel.

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