Sterile body fluid collection device and method

Abstract

To provide devices and methods for parenterally-procuring bodily-fluid samples with reduced contamination from microbes or other contaminants exterior to the bodily-fluid source, such as dermally-residing microbes.SOLUTION: A device includes a pre-sample reservoir, a diversion mechanism, and a flow metering mechanism. The diversion mechanism has an inlet port couplable to a lumen-defining device to receive bodily-fluids from a patient, a first outlet port fluidically couplable to the pre-sample reservoir, and a second outlet port fluidically couplable to a sample reservoir. The diversion mechanism defines a first fluid flow path and a second flow path that are configured to place the first outlet port and the second outlet port, respectively, in fluid communication with the inlet port. The flow metering mechanism is configured to meter a flow of a predetermined volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir, to meter a flow of a second volume of bodily-fluid through the second flow path into the sample reservoir, and to display a volumetric indicator associated with the predetermined volume and the second volume.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[1001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 61,733,199, filed December 4, 2012, entitled "Sterile Bodily-Fluid Collection Device and Methods," the disclosure of which is incorporated herein by reference in its entirety.

[0002]

[1002] FIELD OF THE INVENTION Embodiments described herein relate generally to parenteral procurement of bodily fluid samples, and more particularly to devices and methods for parenterally obtaining bodily fluid samples with reduced contamination from microorganisms or other contaminants external to the source of the bodily fluid, such as microorganisms present on the skin. [Background technology]

[0003]

[1003] Healthcare professionals routinely perform various types of microbiological tests on patients using parenterally obtained bodily fluids. In some cases, patient samples (e.g., bodily fluids) are tested for the presence of one or more potentially undesirable microorganisms, such as bacteria, fungi, or yeasts (e.g., Candida). Microbiological testing may involve culturing the patient sample in one or more sterile containers containing a medium that promotes microbial growth, real-time diagnostics, and / or molecular PCR-based techniques. Generally, if such microorganisms are present in the patient sample, they will multiply in the medium over time. After a variable period of time (e.g., hours to days), automated continuous monitoring can detect the growth of the organisms. Such automated monitoring can detect carbon dioxide produced by the growth of the organisms. The medium can then be tested for the presence of the microorganisms. The presence of the microorganisms in the medium indicates the presence of the same microorganism in the patient sample, which in turn indicates the presence of the same microorganism in the bodily fluids of the patient from whom the sample was obtained. Thus, if the culture medium is determined to be present with microorganisms, the patient may be prescribed one or more antibiotics or other treatments specifically designed to treat or otherwise remove the unwanted microorganisms from the patient.

[0004]

[1004] However, patient samples can become contaminated during acquisition and / or be otherwise prone to false-positive results. One way in which patient sample contamination can occur is through the transfer of surface microorganisms (e.g., microorganisms present on the skin) dislodged during needle insertion into the patient's body and subsequently transferred to the culture medium with the patient sample. Surface microorganisms and / or other undesirable external microorganisms can be dislodged directly or via dislodged tissue debris, hair follicles, sweat glands, and other skin appendage structures. Another potential source of contamination comes from the person drawing the patient sample. For example, a physician, phlebotomist, nurse, etc., can transfer contaminants from their own body (e.g., finger, arm, etc.) to the patient sample and / or to the equipment containing the patient sample. More specifically, the equipment and / or devices used during the patient sample acquisition process (e.g., patient to needle, needle / tube to sample container, etc.) often include multiple fluid interfaces, each of which can introduce potential points of contamination. Use of such instruments and / or devices typically involves manual intervention to connect and / or fluidly couple various interfaces. Because these interfaces are not pre-assembled and sterilized as a single, fluidly coupled system, they can be introduced into the patient sample via the user (e.g., physician, phlebotomist, etc.) and / or other sources of contamination (e.g., ambient air, contaminants on patient room table and counter surfaces, microorganisms transferred from linens or clothing, etc.). In some cases, these contaminants can grow in the culture medium and ultimately result in a positive microorganism test result, thereby falsely indicating the presence of such microorganisms in the body.

[0005]

[1005] In some cases, false-positive and / or false-negative results may be due to the volume of the patient sample. For example, overfilling volume-sensitive blood culture bottles can lead to false-positive results, as noted in the instructions and / or warning labels from the manufacturers of such culture bottles and associated automated, continuous-monitoring microbial detection systems. Alternatively, insufficient patient sample volume in the culture medium can result in false-negative results. For example, in a study conducted by the Mayo Clinic entitled "Optimized Pathogen Detection with 30-Compared to 20-Milliliter Blood Culture Draws," published in the December 2011 issue of the Journal of Clinical Microbiology, a patient sample volume of 20 milliliters (mL) could detect the presence of approximately 80% of bacteremia present in the patient sample, a patient sample volume of 40 mL could detect approximately 88% of bacteremia, and a patient sample volume of 60 mL could detect approximately 99% of bacteremia.

[0006]

[1006] Such inaccurate results as a result of contamination, insufficient patient sample volume, etc., are problematic when attempting to diagnose or treat a suspected disease or health condition. For example, a false-negative result from a microbiology test can result in a patient's illness being misdiagnosed and / or treatment being delayed, which in some cases can lead to the patient's death. Conversely, a false-positive result from a microbiology test can result in a patient receiving one or more antimicrobial therapies unnecessarily, which can cause serious adverse patient side effects, including, for example, death, as well as unnecessary burden and expense to the healthcare system due to extended patient hospital stays and / or other complications associated with incorrect treatment. Furthermore, the use of diagnostic imaging equipment resulting from these false-positive results is also problematic from a patient safety perspective, due to the cost and unnecessary exposure to high-intensity radiation associated with various imaging procedures (e.g., CT scans) that have many known adverse effects on long-term patient health.

[0007]

[1007] Thus, there is a need for a sterile, "all-in-one" bodily fluid collection device and method that reduces microbial contamination in bodily fluid test samples, for example, by minimizing exposure of the patient sample and / or fluid interface to surrounding non-sterile conditions and / or other external sources of contamination. There is also a need for such a bodily fluid collection device to include a means for accurately metering, measuring, and / or otherwise evaluating the bodily fluid transferred from the patient to a sample reservoir or medium that can be visually, computerized, or otherwise communicated to a medical professional obtaining the patient sample in substantially real time (e.g., at the patient's bedside). Summary of the Invention

[0008]

[1008] Described herein are devices for parenterally obtaining a bodily fluid sample with reduced contamination from microorganisms external to the bodily fluid source, such as microorganisms present on the skin and / or other undesirable external contaminants. In some embodiments, an apparatus for obtaining a bodily fluid sample from a patient includes a pre-sample reservoir, a flow diverting mechanism, and a flow metering mechanism. The pre-sample reservoir is configured to receive a first volume of bodily fluid to be drawn from the patient. The flow diverting mechanism includes an inlet port, a first outlet port, and a second outlet port, defining a first fluid flow path and a second fluid flow path. The inlet port can be coupled to a lumen-defining device to receive the bodily fluid from the patient. The first outlet port and the second outlet port are configured to fluidly couple the pre-sample reservoir and the sample reservoir, respectively, to the flow diverting mechanism. The first fluid flow path is configured to fluidly connect the first outlet port to the inlet port, and the second fluid flow path is configured to fluidly connect the second outlet port to the inlet port. The flow metering mechanism is in fluid communication with the first fluid flow path and the second fluid flow path. The flow metering mechanism is configured to meter a first volume of bodily fluid through the first fluid flow path into the pre-sample reservoir and a second volume of bodily fluid through the second fluid flow path into the sample reservoir, and the flow metering mechanism is configured to display volume indicators associated with the first and second volumes. [Brief explanation of the drawings]

[0009] [Figure 1] 1 is a schematic diagram of a bodily fluid collection device according to an embodiment. [Figure 2] 1 is a perspective view of a bodily fluid collection device according to an embodiment. [Figure 3] FIG. 3 is an exploded perspective view of the bodily fluid collection device of FIG. 2. [Figure 4] 3. FIG. 4 is a cross-sectional side view of a housing included in the bodily fluid collection device of FIG. 2 taken along line X1-X1 of FIG. [Figure 5] 3. FIG. 4 is a cross-sectional view of a movable member included in the bodily fluid collection device of FIG. 2 taken along line X2-X2 of FIG. [Figure 6]3. FIG. 4 is a cross-sectional view of a flow controller included in the bodily fluid collection device of FIG. 2 taken along line X3-X3 of FIG. [Figure 7] 4 is a cross-sectional view of a flow controller included in the bodily fluid collection device of FIG. 2 taken along line X4-X4 of FIG. 3. [Figure 8] FIG. 3 is a top view of the bodily fluid collection device of FIG. 2 in a first configuration. [Figure 9] 9 is a cross-sectional view of the bodily fluid collection device of FIG. 2 in a first configuration taken along line X5-X5 of FIG. 8. [Figure 10] FIG. 3 is a top view of the bodily fluid collection device of FIG. 2 in a second configuration. [Figure 11] 16 is a cross-sectional view of the bodily fluid collection device of FIG. 2 in a second configuration, taken along line X6-X6 of FIG. 10. [Figure 12] 16 is a cross-sectional view of the bodily fluid collection device of FIG. 2 in a third configuration, taken along line X6-X6 of FIG. 10. [Figure 13] 16 is a cross-sectional view of the bodily fluid collection device of FIG. 2 in a fourth configuration, taken along line X6-X6 of FIG. 10. [Figure 14] 1 is a perspective view of a bodily fluid collection device according to an embodiment. [Figure 15] 15 is a cross-sectional side view of the bodily fluid collection device of FIG. 14 taken along line X7-X7. [Figure 16] 1 is a perspective view of a bodily fluid collection device according to an embodiment. [Figure 17] FIG. 17 is an exploded perspective view of a flow diverter mechanism included in the bodily fluid collection device of FIG. 16. [Figure 18] 17 is a cross-sectional side view of a distribution member included in the bodily fluid collection device of FIG. 16 taken along line X8-X8 of FIG. 16. [Figure 19] FIG. 17 is a top view of the bodily fluid collection device of FIG. 16 in a first configuration. [Figure 20] 19 is a cross-sectional view of the partial bodily fluid collection device of FIG. 16 in a first configuration taken along line X9-X9 of FIG. 19. [Figure 21] FIG. 17 is a top view of the bodily fluid collection device of FIG. 16 in a second configuration. [Figure 22] 20 is a cross-sectional view of the bodily fluid collection device of FIG. 16 in a second configuration taken along line X10-X10 of FIG. 21. [Figure 23] 1 is a perspective view of a bodily fluid collection device according to an embodiment. [Figure 24] 24 is a cross-sectional view taken along line X11-X11 of a portion of the bodily fluid collection device of FIG. 23 in a first configuration. [Figure 25] 24 is a cross-sectional view taken along line X11-X11 of the bodily fluid collection device of FIG. 23 in a second configuration. [Figure 26] 1 is a perspective view of a bodily fluid collection device according to an embodiment. [Figure 27] FIG. 27 is an exploded perspective view of a flow diverter mechanism included in the bodily fluid collection device of FIG. 26. [Figure 28] 28 is a cross-sectional view of a distribution member included in the bodily fluid collection device of FIG. 27 taken along line X13-X13 of FIG. 27. [Figure 29] 27 is a cross-sectional view of a coupling member included in the bodily fluid collection device of FIG. 26 taken along line X14-X14 of FIG. 27. [Figure 30] 27 is a cross-sectional view of a dial included in the bodily fluid collection device of FIG. 26 taken along line X15-X15 of FIG. 27. [Figure 31] 27. FIG. 28 is a cross-sectional view of a valve included in the bodily fluid collection device of FIG. 26 taken along line X16-X16 of FIG. [Figure 32] 27 is a cross-sectional view taken along line X12-X12 of the bodily fluid collection device of FIG. 26 in a first configuration. [Figure 33] 27 is a cross-sectional view taken along line X12-X12 of the bodily fluid collection device of FIG. 26 in a second configuration. [Figure 34] 1 is a perspective view of a bodily fluid collection device according to an embodiment. [Figure 35] FIG. 35 is an exploded perspective view of a flow diverter mechanism included in the bodily fluid collection device of FIG. 34. [Figure 36] 36 is a cross-sectional view taken along line X17-X17 of a distribution member included in the flow dividing mechanism of FIG. 35. FIG. [Figure 37] FIG. 35 is a top view of a portion of the bodily fluid collection device of FIG. 34 in a first configuration. [Figure 38] 38 is a cross-sectional view taken along line X18-X18 of the partial bodily fluid collection device of FIG. 37 in the first configuration. [Figure 39] FIG. 34 is a top view of the bodily fluid collection device of FIG. 33 in a second configuration. [Figure 40] 39. FIG. 40 is a cross-sectional view of the bodily fluid collection device of FIG. 33 in a second configuration, taken along line X19-X19 of FIG. [Figure 41] 1 is a perspective view of a bodily fluid collection device in a first configuration according to an embodiment. [Figure 42] FIG. 42 is an exploded perspective view of a portion of the bodily fluid collection device of FIG. 41. [Figure 43] 42 is a cross-sectional view taken along line X20-X20 of the bodily fluid collection device of FIG. 41 in a first configuration. [Figure 44] 42 is a cross-sectional view taken along line X20-X20 of the bodily fluid collection device of FIG. 41 in a second configuration. [Figure 45] 42 is a cross-sectional view taken along line X20-X20 of the bodily fluid collection device of FIG. 41 in a third configuration. [Figure 46] 1 is a perspective view of a bodily fluid collection device in a first configuration according to an embodiment. [Figure 47] FIG. 46 is an exploded perspective view of a portion of the bodily fluid collection device of FIG. 45. [Figure 48] 48 is a cross-sectional side view of a distribution member included in the bodily fluid collection device of FIG. 46 taken along line X21-X21 of FIG. 47. [Figure 49] 48 is a cross-sectional side view of a movable member included in the bodily fluid collection device of FIG. 46 taken along line X22-X22 of FIG. 47. [Figure 50] FIG. 47 is a top view of the bodily fluid collection device of FIG. 46 in a first configuration. [Figure 51] 50. FIG. 51 is a cross-sectional view taken along line X23-X23 of FIG. 50 of the partial bodily fluid collection device of FIG. 46 in a first configuration. [Figure 52]FIG. 47 is a top view of the bodily fluid collection device of FIG. 46 in a second configuration. [Figure 53] 52. FIG. 53 is a cross-sectional view of the bodily fluid collection device of FIG. 46 in a second configuration, taken along line X24-X24 of FIG. [Figure 54] 1 is a perspective view of a bodily fluid collection device according to an embodiment. [Figure 55] FIG. 55 is a top view of the bodily fluid collection device of FIG. 54. [Figure 56] 1 is a flow chart illustrating a method for obtaining a bodily fluid sample with reduced contamination using a collection device according to an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0010]

[1063] Described herein are devices for parenterally obtaining a bodily fluid sample with reduced contamination from microorganisms external to the bodily fluid source, such as microorganisms present on the skin and / or other undesirable external contaminants. In some embodiments, an apparatus for obtaining a bodily fluid sample from a patient includes a pre-sample reservoir, a flow diverting mechanism, and a flow metering mechanism. The pre-sample reservoir is configured to receive a first volume of bodily fluid to be drawn from the patient. The flow diverting mechanism includes an inlet port, a first outlet port, and a second outlet port, defining a first fluid flow path and a second fluid flow path. The inlet port can be coupled to a lumen-defining device to receive the bodily fluid from the patient. The first outlet port and the second outlet port are configured to fluidly couple the pre-sample reservoir and the sample reservoir, respectively, to the flow diverting mechanism. The first fluid flow path is configured to fluidly connect the first outlet port to the inlet port, and the second fluid flow path is configured to fluidly connect the second outlet port to the inlet port. The flow metering mechanism is in fluid communication with the first fluid flow path and the second fluid flow path. The flow metering mechanism is configured to meter a first volume of bodily fluid through the first fluid flow path into the pre-sample reservoir and a second volume of bodily fluid through the second fluid flow path into the sample reservoir, and the flow metering mechanism is configured to display volume indicators associated with the first and second volumes.

[0011]

[1064] In some embodiments, an apparatus for obtaining a bodily fluid sample from a patient includes a pre-sample reservoir, a flow diversion mechanism, a flow controller, and a movable member. The pre-sample reservoir is configured to receive a first volume of bodily fluid drawn from the patient. The flow diversion mechanism includes an inlet port, a first outlet port, and a second outlet port. The inlet port is connectable to a lumen-defining device to receive the bodily fluid from the patient. The first outlet port fluidly connects the pre-sample reservoir to the flow diversion mechanism, and the second outlet port fluidly connects the sample reservoir to the flow diversion mechanism. The flow controller is at least partially disposed within the flow diversion mechanism, and is movable between a first configuration in which the flow controller defines at least a portion of a fluid flow path between the inlet port and the first outlet port and a second configuration in which the flow controller defines at least a portion of a fluid flow path between the inlet port and the second outlet port. The movable member is movably coupled to the flow diverter mechanism and is movable through the second outlet port between a first configuration in which the sample reservoir is fluidly isolated from the fluid flow path between the inlet port and the second outlet port and a second configuration in which the sample reservoir is fluidly connected to the fluid flow path between the inlet port and the second outlet port, The sample reservoir is configured to receive a second volume of bodily fluid drawn from the patient when the flow controller is in the second configuration and the movable member is in the second configuration.

[0012]

[1065] In some embodiments, an apparatus for obtaining a bodily fluid sample from a patient includes a pre-sample reservoir, a flow diversion mechanism, and a flow controller. The pre-sample reservoir is configured to receive a first volume of bodily fluid drawn from the patient. The flow diversion mechanism includes a housing and a distribution member. The housing defines a first opening and a second opening in fluid communication with the pre-sample reservoir. The distribution member is at least partially disposed within the housing and defines a fluid flow path in fluid communication with the second opening. The distribution member includes a coupling portion in fluid communication with the flow path and configured to be physically and fluidly coupled to the sample reservoir. The flow controller includes an inlet port configured to be coupled to the lumen-defining device to receive the bodily fluid from the patient. The flow controller is rotatably coupled to the flow diversion mechanism and is movable between a first configuration in which the inlet port is in fluid communication with the first opening and a second configuration in which the inlet port is in fluid communication with the second opening.

[0013]

[1066] In some embodiments, a method for using a flow metering transfer device having a flow dividing mechanism including an inlet port configured to be selectively positioned in fluid communication with a pre-sample reservoir and a sample reservoir, and a flow metering mechanism configured to meter a flow of bodily fluid from a patient to the pre-sample reservoir and to the sample reservoir, includes establishing fluid communication between the patient and the inlet port of the flow metering transfer device. Fluid communication is then established between the port and the pre-sample reservoir. The flow of bodily fluid transferred from the patient to the pre-sample reservoir is metered. The method includes verifying, via the flow metering mechanism of the flow metering transfer device, that a pre-sample volume of the bodily fluid placed in the pre-sample reservoir is a first pre-sample volume of the bodily fluid. With the pre-sample volume placed in the pre-sample reservoir, the pre-sample reservoir is fluidly isolated from the port to seal the pre-sample volume of the bodily fluid within the pre-sample reservoir. With the pre-sample reservoir fluidically isolated, the method includes establishing fluid communication between the port and the sample reservoir. A flow of bodily fluid transferred from the patient to the sample reservoir is metered. The method includes verifying, via a flow metering mechanism of a flow metering transfer device, that a sample volume of the bodily fluid placed in the sample reservoir is a first sample volume of the bodily fluid.

[0014]

[1067] In some embodiments, the device includes a flow dividing mechanism and a flow controller. The flow dividing mechanism can define an inlet port, a first outlet port, a second outlet port, and a third outlet port. The first outlet port can be fluidly coupled to the pre-sample reservoir, the second outlet port can be fluidly coupled to the first sample reservoir, the third outlet port can be fluidly coupled to the second sample reservoir, etc. All of the fluid reservoirs can be fluidly isolated from one another. The flow controller can include various fluid channels, which can allow fluid movement in specified directions and can be configured to be operably coupled to the flow dividing mechanism. In use, when the flow dividing mechanism is in a first configuration, the flow controller can allow a flow of bodily fluid into the pre-sample reservoir. The flow dividing mechanism can be moved to a second configuration, where the flow controller can allow a flow of bodily fluid into the first sample reservoir. Furthermore, the flow dividing mechanism can subsequently be moved to a third configuration, whereby the flow controller can allow a flow of bodily fluid into the second sample reservoir.

[0015]

[1068] In some embodiments, the bodily fluid collection device can be configured to selectively divert a first predetermined volume of bodily fluid to a pre-sample reservoir before allowing the flow of a second volume of bodily fluid into the first sample reservoir and / or a third volume of bodily fluid into the second sample reservoir. In this manner, the second and / or third volumes of bodily fluid can be used for diagnostic or other testing, while isolating the first volume of bodily fluid, which may contain microorganisms from the body surface or other microbial sources external to the patient from whom the sample is obtained. In some embodiments, the bodily fluid collection device can include additional sample reservoirs (e.g., 3, 4, 5, 6 or more) depending on the analytical and / or testing protocols to be performed.

[0016]

[1069] In some embodiments, the bodily fluid collection device can include flow metering to ensure an appropriate volume of bodily fluid is collected from the patient and / or transferred to a predetermined pre-sample reservoir and / or sample reservoir. The bodily fluid collection device can be configured to automatically divert and / or control fluid flow after a metered volume of bodily fluid is collected. For example, once a first metered pre-sample volume is collected, the diverting mechanism can be configured to divert the bodily fluid flow to a first sample reservoir; thereafter, once a first metered sample volume is collected, the diverting mechanism can be configured to divert the bodily fluid flow to a second sample reservoir, etc. In some embodiments, the bodily fluid collection device can include a metered volume display, such as a liquid crystal display (LCD), to provide a user with a visual indication of how much bodily fluid has been collected in each predetermined individual sample reservoir. In some embodiments, multiple displays can be provided to allow for customized pre-sample and / or sample volume collection.

[0017]

[1070] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "an element" is intended to mean a single element or a combination of elements, and "a material" is intended to mean one or more materials or combinations thereof.

[0018]

[1071] As used herein, "body fluid" can include any fluid obtained from within a patient's body, including, but not limited to, blood, cerebrospinal fluid, urine, bile, lymphatic fluid, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, etc., or any combination thereof.

[0019]

[1072] As used herein, the terms "first predetermined amount," "first amount," and "first volume" describe an amount of bodily fluid configured to be received or contained by a first reservoir or pre-sample reservoir. Although the terms "first amount" and "first volume" do not explicitly describe a predetermined amount, it should be understood that a first amount is a first predetermined amount unless explicitly stated differently.

[0020]

[1073] As used herein, the terms "second amount" and "second volume" refer to an amount of bodily fluid configured to be received or contained by a second or sample reservoir. The second amount can be any suitable amount of bodily fluid and need not be a predetermined amount. Conversely, when expressly stated as such, the second amount received and contained by a second or sample reservoir can be a second predetermined amount.

[0021]

[1074] As used herein, the term "set" can refer to multiple features or a single feature that includes multiple parts. For example, when referring to a set of walls, the set of walls can be considered a wall that includes separate portions, or the set of walls can be considered multiple walls. Similarly, an integrally constructed article can include a set of walls. Such a set of walls can include, for example, multiple portions that are discontinuous with one another. A set of walls can also be made from multiple articles that are manufactured separately and then joined together (e.g., via welding, adhesive, or any suitable method).

[0022]

[1075] As used herein, the terms "proximal" and "distal" refer to directions toward and away from a user who places the device in contact with a patient. Thus, for example, the end of the device that first contacts the patient's body would be the distal end, and the opposite end of the device (e.g., the end of the device that is manipulated by the user) would be the proximal end of the device.

[0023]

[1076] As used herein, the terms "about," "approximately," and "substantially," when used in connection with a numerical value, are intended to mean that the value so defined is the nominally indicated value. In other words, the terms "about," "approximately," and "substantially," when used in connection with a numerical value, generally include the indicated value plus or minus a given tolerance. For example, in some cases, a suitable tolerance may be ±10% of the indicated value, so that about 0.5 includes 0.45 and 0.55, about 10 includes 9-11, and about 1000 includes 900-1100. In other cases, a suitable tolerance may be plus or minus an acceptable percentage of the last significant digit of the indicated value. For example, a suitable tolerance may be ±10% of the last significant digit, so that about 10.1 includes 10.09 and 10.11, and about 25 includes 24.5 and 25.5. Such variations may result from manufacturing tolerances or other practical considerations (e.g., tolerances associated with measuring instruments, allowable human error, etc.).

[0024]

[1077] When describing the relationship between a predetermined volume of bodily fluid and a collected volume of bodily fluid, it should be understood that these values ​​include suitable tolerances, such as those described above. For example, when describing a collected volume of bodily fluid as substantially equal to a predetermined volume of bodily fluid, the collected volume and the predetermined volume are nominally equal within a suitable tolerance. In some cases, the tolerance can be determined by the intended use of the collected volume of bodily fluid. For example, in some cases, a blood culture assay can be approximately 99% accurate when the collected volume of blood is within 1.0% to 5.0% of the manufacturer's (or evidence-based best practice) recommended volume. As an example, the manufacturer's recommended volume for a bodily fluid assay can be 10 milliliters (mL) per sample collection bottle (i.e., a total volume of 40 mL to 60 mL) ±5% when a total of four or six collection bottles are used, for approximately 99% confidence. Thus, a collection volume of 10.5 mL provides results with greater than about 99% confidence, and a collection volume of 11 mL provides results with less than about 99% confidence. In other cases, a suitable tolerance may be 0.1%, 0.5%, 1.0%, 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0%, 10.0%, or any fractional value therebetween. In still other cases, the tolerance may be greater than 10.0%. Accordingly, any of the embodiments described herein may include and / or be used in conjunction with any suitable flow measurement mechanism and / or device configured to meter the flow rate of bodily fluids and / or otherwise measure the volume of bodily fluids within a suitable tolerance range. Furthermore, the flow metering mechanism and / or device may be positioned to minimize or eliminate tolerance buildup that may result from a combination of inaccurate measurements, human error, etc.

[0025]

[1078] 1 is a schematic diagram of a portion of a bodily fluid collection device 100, according to an embodiment. Generally, bodily fluid collection device 100 (also referred to herein as a "fluid collection device" or "collection device") is configured to allow bodily fluid to be withdrawn from a patient, with a first portion or quantity of the withdrawn bodily fluid being diverted away from a second and / or third portion or volume of the withdrawn bodily fluid to be used as a biological sample, such as to be tested for medical diagnostic and / or therapeutic purposes. In other words, as described in more detail herein, collection device 100 is configured to transfer a first predetermined volume of the bodily fluid to a pre-sample collection reservoir and second and third (or, in some embodiments, fourth, fifth, etc.) volumes of the bodily fluid to one or more sample collection reservoirs (e.g., sample reservoirs) fluidly isolated from the pre-sample reservoir.

[0026]

[1079] The collection device 100 includes a flow dividing mechanism 120, a flow controller 140, a pre-sample reservoir 170, a first sample reservoir 180, and a second sample reservoir 190 different from the first sample reservoir 180. The flow dividing mechanism 120 includes an inlet port 121 and at least two outlet ports, such as a first outlet port 125 and a second outlet port 126, as shown in FIG. 1 . In some embodiments, the flow dividing mechanism 120 can include a set of outlet ports equal to the total number of pre-sample and sample reservoirs. For example, if the collection device 100 has one pre-sample and four sample reservoirs, the flow dividing mechanism 120 can include five outlet ports. In some embodiments, the flow dividing mechanism 120 can be operably coupled to an actuator (not shown in FIG. 1 ) that can facilitate movement of the flow dividing mechanism 120 between multiple configurations. Inlet port 121 is configured to be fluidly coupled to a medical device defining a pathway X for withdrawing and / or transporting bodily fluid from a patient to collection device 100. For example, inlet port 121 may be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). In this manner, flow diverter mechanism 120 may receive bodily fluid from a patient through a needle or any other lumen-defining device.

[0027]

[1080] The first outlet port 125 of the flow division mechanism 120 can be fluidly coupled to the pre-sample reservoir 170. In some embodiments, the pre-sample reservoir 170 is integrally formed with the first outlet port 125 and / or a portion of the flow division mechanism 120. In other embodiments, the pre-sample reservoir 170 can be mechanically and / or fluidly coupled to the flow division mechanism 120 via adhesive, a resistance fit, a mechanical fastener, any number of mating recesses, a threaded connection, and / or any other suitable connection or combination thereof. Similarly, the pre-sample reservoir 170 can be physically (e.g., mechanically) coupled to the flow division mechanism 120 such that an interior volume defined by the pre-sample reservoir 170 is in fluid communication with the first outlet port 125 of the flow division mechanism 120. In yet other embodiments, pre-sample reservoir 170 can be operably coupled to first outlet port 125 of flow diversion mechanism 120 via an intervening structure (not shown in FIG. 1 ), such as flexible sterile tubing. More particularly, the intervening structure can define a lumen configured to place pre-sample reservoir 170 in fluid communication with first outlet port 125.

[0028]

[1081] Pre-sample reservoir 170 is configured to receive and contain a first predetermined volume of bodily fluid. In some embodiments, pre-sample reservoir 170 is configured to contain the first volume of bodily fluid in fluid isolation from a second and / or third volume of bodily fluid (which may be the same as or different from the first volume of bodily fluid) that is subsequently drawn from the patient. Pre-sample reservoir 170 may be any suitable reservoir for containing bodily fluid, such as the pre-sample reservoirs described in detail in U.S. Pat. No. 8,197,420, entitled "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination," which is incorporated herein by reference in its entirety.

[0029]

[1082] In some embodiments, the second outlet port 126 of the flow diversion mechanism 120 is configured to be fluidly coupled to a lumen-defining device, which can be coupled to the first sample reservoir 180 and the second sample reservoir 190. Optionally, in other embodiments, the second outlet port 126 of the flow diversion mechanism 120 can be coupled to the first sample reservoir 180, and the flow diversion mechanism 120 can have a third outlet port (not shown) coupled to the second sample reservoir 190. In some embodiments, the first sample reservoir 180 can be integrally formed with the second outlet port 126 and / or a portion of the flow diversion mechanism 120. In other embodiments, the first sample reservoir 180 can be mechanically coupled to the second outlet port 126 or operably coupled to the second outlet port 126 via an intervening structure such as those described above with respect to the pre-sample reservoir 170. The first sample reservoir 180 is configured to receive and contain a second volume of bodily fluid. For example, the second volume of bodily fluid may be an amount drawn from the patient following the drawing of the first pre-sample volume. In some embodiments, the first sample reservoir 180 is configured to contain the second volume of bodily fluid such that the second volume is fluidly isolated from the first volume of pre-sample bodily fluid.

[0030]

[1083] First sample reservoir 180 and second sample reservoir 190 can be any suitable sterile reservoir for containing bodily fluid, including, for example, sample reservoirs such as those described in the '420 patent incorporated by reference above. In some embodiments, the second volume can be any suitable volume of bodily fluid and need not be a predetermined volume. In other embodiments, transfer of bodily fluid to first sample reservoir 180 and / or second sample reservoir 190 can be metered, etc., such that the second volume is a second predetermined volume.

[0031]

[1084] The second sample reservoir 190 can be any suitable sample reservoir. In some embodiments, the second sample reservoir 190 can be substantially similar to the first sample reservoir 180 described above. The second sample reservoir 190 can be fluidly coupled to the second outlet port 126, as described above. The fluid coupling of the second outlet port 126 to the second sample reservoir 190 can be substantially similar to the fluid coupling of the second outlet port 126 to the first sample reservoir 180, as described in detail above. Accordingly, such portions will not be described in further detail herein and should be considered to be substantially similar unless explicitly described differently. Furthermore, additional outlet ports and sample reservoirs of the flow dividing mechanism 120 (not shown in FIG. 1 ) can be substantially similar to the second outlet port 126 and the first sample reservoir 180.

[0032]

[1085] In some embodiments, pre-sample reservoir 170, first sample reservoir 180, and second sample reservoir 190 may be similarly coupled to (or formed together with) flow diversion mechanism 120. In other embodiments, pre-sample reservoir 170, first sample reservoir 180, and second sample reservoir 190 need not be similarly coupled to flow diversion mechanism 120. For example, in some embodiments, pre-sample reservoir 170 may be integrally formed with flow diversion mechanism 120 (e.g., first outlet port 124), and first sample reservoir 180 and / or second sample reservoir 190 may be operably coupled to flow diversion mechanism 120 (e.g., second outlet port 126) via an intervening structure, such as flexible sterile tubing, or any combination thereof.

[0033]

[1086] In some embodiments, the collection device 100 can further include an actuator (not shown in FIG. 1 ) and a flow controller 140 that defines a first fluid flow path 142, a second fluid flow path 144, and optionally additional fluid flow paths (not shown in FIG. 1 ). In some embodiments, the actuator can be included in or otherwise operably coupled to the flow diverter mechanism 120. In this manner, the actuator can be configured to control fluid movement within the flow controller 140 (e.g., between different configurations). For example, the actuator can be movable between a first position corresponding to a first configuration of the flow controller 140, a second position different from the first position corresponding to a second configuration of the flow controller 140, etc. In some embodiments, the actuator can be configured to move unidirectionally. For example, the actuator can be moved from its first position to its second position, but cannot be moved from its second position to its first position. Similarly, the actuator can be moved from its second position to a third position, but cannot be moved from its third position back to its second position. In this way, flow controller 140 is prevented from moving to its second or third configuration before its first configuration, so that a first amount of bodily fluid is directed to pre-sample reservoir 170 and not to sample reservoirs 180 and / or 190 designed to contain a second and / or third volume of extracted fluid to be used as a biological sample, such as for testing for medical diagnostic and / or therapeutic purposes.

[0034]

[1087] The flow controller 140 is configured such that when in the first configuration, the first fluid flow path 142 fluidly couples the inlet port 121 to the first outlet port 125, and when in the second configuration, the second fluid flow path 144 fluidly couples the inlet port 121 to the second outlet port 126. In some embodiments, an actuator, such as those described above, can be configured to translate the flow controller 140 between the first and second configurations, and optionally, the third or fourth configurations. For example, in some embodiments, the flow controller 140 can be in the first configuration when in a distal position relative to the collection device 100. In such embodiments, the actuator can be actuated to move the flow controller 140 proximally to a proximal position relative to the collection device 100, thereby placing the flow controller 130 in the second configuration. In other embodiments, the actuator can be actuated to rotate the flow controller 140 between the first and second configurations, or optionally, the third or fourth configurations.

[0035]

[1088] Thus, when flow controller 140 is in the first configuration, second outlet port 126 (and optionally, an additional outlet port coupled to a sample reservoir) is fluidly isolated from inlet port 121. Similarly, when flow controller 140 is in the second configuration, first outlet port 125 is fluidly isolated from inlet port 121. Optionally, when flow controller 140 is in a third configuration (not shown in FIG. 1 ), first outlet port 125 and second outlet port 126 are fluidly isolated from inlet port 121. In this way, when flow controller 140 is in the first configuration, it can direct or divert a first amount of bodily fluid via first outlet port 125 to pre-sample fluid reservoir 170, and when flow controller 140 is in the second configuration, it can direct or divert a second amount of bodily fluid via second outlet port 126 to first sample fluid reservoir 180.

[0036]

[1089] In some embodiments, at least a portion of the actuator can be operably coupled to the pre-sample fluid reservoir 170. As such, the actuator (or at least a portion of the actuator) can be configured to cause or otherwise facilitate the creation of a vacuum in the "pre-sample" fluid reservoir 170, thereby initiating the flow of bodily fluid through the collection device 100 and into the pre-sample fluid reservoir 170 when the flow diverter mechanism 120 is in its first configuration. The actuator can include any suitable mechanism for driving the flow of bodily fluid into the collection device 100, such as, for example, a rotating disk, a plunger, a slide, a dial, a button, a handle, a lever, and / or any other suitable mechanism or combination thereof. Examples of suitable actuators are described in more detail herein with reference to specific embodiments.

[0037]

[1090] In some embodiments, flow diversion mechanism 120 can be configured to require transport of a first quantity of bodily fluid to pre-sample fluid reservoir 170 before allowing a second quantity of bodily fluid to flow through flow diversion mechanism 120 to first sample fluid reservoir 180 and / or second sample fluid reservoir 190. In this manner, flow diversion mechanism 120 can be characterized as requiring compliance by a medical professional with collecting a first predetermined quantity of bodily fluid (e.g., a pre-sample) before collecting a second and / or third quantity of bodily fluid (e.g., a sample). Similarly, flow diversion mechanism 120 can be configured to prevent a medical professional from collecting a second quantity of bodily fluid, i.e., a sample, in first sample fluid reservoir 180 without first diverting the first quantity of bodily fluid, i.e., the pre-sample, to pre-sample reservoir 170. In this way, the healthcare professional is prevented from including (intentionally or unintentionally) a first amount of bodily fluid that is more likely to contain surface microorganisms and / or other undesirable external contaminants in the bodily fluid sample used for analysis. In other embodiments, the fluid collection device 100 need not include any mandatory compliance features or components.

[0038]

[1091] In some embodiments, flow diverter structure 120 can have a fourth configuration (not shown in FIG. 1 ) that is different from the first, second, and third configurations. When in the fourth configuration, flow diverter structure 120 can simultaneously fluidly isolate inlet port 121 from first outlet port 125, second outlet port 126, and optionally, third outlet port. Thus, when flow diverter structure 120 is in its fourth configuration, bodily fluid is prevented from flowing from inlet port 121 to pre-sample fluid reservoir 170, first sample fluid reservoir 180, and second sample fluid reservoir 190. In use, for example, flow diverter mechanism 120 can be actuated (e.g., manually or automatically) to place flow diverter mechanism 120 in a first configuration to allow bodily fluid to flow from inlet port 121 to pre-sample fluid reservoir 170, then moved to a second configuration to allow bodily fluid to flow from inlet port 121 to first sample fluid reservoir 180, optionally moved to a third configuration to allow bodily fluid to flow from inlet port 121 to second sample fluid reservoir 190, and then moved to a fourth configuration to stop the flow of bodily fluid into and / or through flow diverter mechanism 120. In this manner, the device is effectively “locked” and self-contained in the fourth configuration to prevent any residual bodily fluid within device 100 from contaminating and / or otherwise exposing medical personnel and / or patients to potentially hazardous fluids. This optional safety feature can prevent potential exposure to bodily fluid samples that may be infected with pathogens such as HIV, Hepatitis C, etc.

[0039]

[1092] In some embodiments, one or more portions of the collection device 100 are disposed within a housing (not shown in FIG. 1 ). For example, in some embodiments, at least a portion of the flow diversion mechanism 120, the first pre-sample reservoir 170, and one or more of the sample reservoirs 180 and 190 can be disposed within the housing. In such embodiments, at least a portion of the flow diversion mechanism 120 is accessible through the housing such that a user can activate the flow controller 140 to control the flow of bodily fluid from the patient (e.g., a vein) to the collection device 100. Examples of suitable housings are described in more detail herein with reference to specific embodiments.

[0040]

[1093] In some embodiments, the collection device 100 can optionally include one or more flow metering devices capable of metering the flow of bodily fluid through the collection device. For example, the flow metering devices can be fluidly connected to the first fluid flow path 142 and / or the second fluid flow path 144 to meter the flow of bodily fluid therethrough. In other embodiments, the flow metering devices can be fluidly connected to and / or otherwise disposed at the first port 125 and / or the second port 126. The flow metering devices can include indicators or the like (e.g., dials, displays, colors, tactile output devices, electrical signal output devices such as wireless radio signals, Bluetooth radio signals, etc.) that can be configured to provide an indication to a user related to a predetermined volume being transferred to the pre-sample reservoir 170, the first sample reservoir 180, and / or the second sample reservoir 190. In some embodiments, the flow metering devices can be operably coupled to actuators or the like, such as those described above. In such embodiments, the flow metering device may be operable to activate an actuator to move the flow controller 140 between its first configuration and its second configuration based on a desired volume of bodily fluid flowed through the flow metering device. Thus, the flow metering device may be used to ensure that a desired volume of bodily fluid is transferred to the pre-sample reservoir 170, the first sample reservoir 180, and / or the second sample reservoir 190, thereby preventing insufficient, inaccurate, and / or erroneous results, such as in microbiological testing of a patient sample.

[0041]

[1094] 2-13, collection device 200 includes a flow diverter mechanism 220, a flow controller 240, a pre-sample reservoir 270, a first sample reservoir 280, and a second sample reservoir 290 that is different from first sample reservoir 280. As described further herein, collection device 200 can be moved between a first configuration, a second configuration, and a third configuration to deliver a flow of bodily fluid that is substantially free of extracorporeal microorganisms, such as microorganisms present on the skin and / or other undesirable external contaminants. Collection device 200 can be of any suitable shape, size, or configuration. For example, while sample reservoirs 280 and / or 290 are shown in FIGS. 2-13 as being oriented perpendicularly relative to housing 201, collection device 200 can have sample reservoirs 280 and / or 290 oriented planarly relative to housing 201, arranged conically relative to housing 201, etc.

[0042]

[1095] Flow dividing mechanism 220 includes housing 201 and movable members 250 and 250′. As shown in FIGS. 2 to 4 , housing 201 is coupled to pre-sample reservoir 270, first sample reservoir 280, and second sample reservoir 290. Housing 201 defines internal flow path 235, which includes inlet port 221, first outlet port 230, second outlet port 231, and third outlet port 232 and can define a fluid flow path for collecting bodily fluid from a patient. Inlet port 221 can be selectively positioned to be fluidly connected to internal flow path 235. More specifically, inlet port 221 defines inlet lumen 202 that can be positioned to be fluidly connected to internal flow path 235. In this manner, inlet port 221 extends from a portion of housing 201 such that internal flow path 235 can be positioned to be fluidly connected to a space substantially outside housing 201 via inlet lumen 202. Inlet port 221 can be fluidly coupled to a medical device (not shown) defining a fluid flow path for withdrawing bodily fluid from a patient and / or transporting bodily fluid to collection device 200. For example, inlet port 221 can be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) directly or indirectly via adapter 204. Similarly, inlet lumen 202 defined by inlet port 221 is disposed in fluid communication with a lumen defined by the lumen-defining device when the lumen-defining device is coupled to inlet port 221. More particularly, when the lumen-defining device is disposed within a portion of a patient's body (e.g., within a patient's vein or spinal cavity), internal flow path 235 of housing 201 can be disposed in fluid communication with that portion of the patient's body.

[0043]

[1096] Internal flow path 235 defined by housing 201 is a central lumen extending along the length of housing 201 that can be positioned to be in fluid communication with a patient's bodily fluid following venipuncture (or other method employed to provide access to bodily fluids) as described herein. Internal flow path 235 forms a fluid flow path that transfers bodily fluid between inlet port 221 and first outlet port 230, second outlet port 231, and third outlet port 232. More specifically, when internal flow path 235 is positioned in fluid communication with a patient (e.g., via a medical device coupled to inlet port 221), first outlet port 230, second outlet port 231, and third outlet port 232 can be selectively positioned in fluid communication with internal flow path 235 to allow bodily fluid to flow into at least one of pre-sample reservoir 270, first sample reservoir 280, or second sample reservoir 290. In some embodiments, bodily fluid is prevented from flowing to the second outlet port 231 and the third outlet port 232 before a predetermined volume of bodily fluid has collected in the pre-sample reservoir 270. In some embodiments, the second outlet port 231 and the third outlet port 232 can be simultaneously positioned in fluid communication with the internal flow path 235. In some embodiments, the second outlet port 231 and the third outlet port 232 can be sequentially positioned in fluid communication with the internal flow path 235.

[0044]

[1097] Movable members 250, 250' are configured to be actuated (e.g., moved) by a user from a first position and a second position relative to housing 201 to direct fluid flow into first sample reservoir 280 and second sample reservoir 290. Movable members 250 and 250' are substantially identical and therefore will be described with reference to a single movable member 250. As shown in FIG. 5 , movable member 250 includes a boss 251 defining an internal cavity 252, an inlet port 253, a first outlet port 254, and a piercing member 255 defining a lumen 256 fluidly coupled to internal cavity 252. Inlet port 253 and outlet port 254 extend through a wall of boss 251 that defines internal chamber 252 of movable member 250. Movable member 250 is configured to be attached to support 257 (see FIG. 4) of housing 201 such that boss 251 is disposed within bore 258 (see FIG. 4) and at least a portion of movable member 250 is disposed within annular chamber 260. Optionally, a biasing member 259 (e.g., a spring) can be disposed within annular chamber 260 to return movable member 250 to its first position after actuation by a user. In some embodiments, movable member 250, annular chamber 260, bore 258, or boss 251 can include a mechanical locking mechanism configured to retain movable member 250 in a second position (e.g., a depressed position) after actuation by a user.

[0045]

[1098] As described herein, in the first configuration, movable member 250 is positioned such that it is spaced apart from internal flow path 235. In such a configuration, a fluid flow path cannot be established between a portion of a patient's body (e.g., a vein, a spinal cavity, etc.) and sample reservoirs 280 and / or 290. In other words, when movable member 250 is in its first configuration, first sample reservoir 280 and second sample reservoir 290 are fluidly isolated from internal flow path 235 defined by housing 201. Movable member 250 can be actuated by a user to move movable member 250 from the first configuration to the second configuration and into alignment with internal flow path 235. The force applied by the user can be sufficient to deform (e.g., compress) biasing member 259, thereby allowing piercing member 255 to be inserted into sample reservoirs 280 and / or 290. In the second configuration, inlet port 253 and outlet port 254 are substantially aligned with internal flow path 235, placing internal cavity 252 in fluid communication with internal flow path 235. Thus, when movable member 250 is in the second configuration, a fluid flow path is established between internal flow path 235, internal cavity 252, lumen 256 of piercing member 255, and sample reservoir 280. In other words, in such a configuration, bodily fluid can flow from the patient (e.g., a vein, spinal cavity, etc.) through flow diversion mechanism 220 and into first sample reservoir 280 and / or second sample reservoir 290, as described in further detail herein.

[0046]

[1099] The pre-sample reservoir 270 can be any suitable reservoir for containing a bodily fluid, such as, for example, a single-use disposable collection tube, a vacuum collection tube, etc. The pre-sample reservoir 270 is configured to be fluidly coupled to the first outlet port 230 of the collection device 200 in any suitable manner (either directly or via an intervening structure such as sterile flexible tubing). For example, in some embodiments, a portion of the pre-sample reservoir 270 can form a friction fit within a portion of the first outlet port 230. In other embodiments, the pre-sample reservoir 270 can be coupled to the first outlet port 230 via a threaded connection, adhesive, a snap fit, mechanical fasteners, and / or any other suitable coupling method. In some embodiments, the pre-sample reservoir 270 can be integrally formed with the housing 201. Pre-sample reservoir 270 can be configured to maintain a negative pressure (vacuum) therein that can enable bodily fluid to be drawn via vacuum suction from inlet port 221 through outlet port 230 and into pre-sample reservoir 270. Pre-sample reservoir 270 is configured to contain a first amount of bodily fluid, which can be a predetermined or undetermined amount, whereby the first amount of bodily fluid is fluidly isolated from second and / or third amounts of bodily fluid that are subsequently withdrawn from the patient.

[0047]

[1100] Sample reservoirs 280 and / or 290 may be any suitable reservoir for containing bodily fluids, including single-use disposable collection tubes, vacuum collection tubes, sample reservoirs such as those described in the '420 patent, which are incorporated herein by reference, and the like. In some embodiments, sample reservoirs 280 and / or 290 may be substantially similar to or the same as known sample containers, such as, for example, Vacutainers®. Sample reservoirs 280 and 290 include sample vessels 282 and 292, respectively, which include vacuum seals 284 and 294, respectively. Vacuum seals 284 or 294 maintain a negative pressure (vacuum) within sample vessels 282 or 292, respectively, which may allow bodily fluids to be drawn into sample vessels 282 or 292, respectively, from internal flow path 235 via vacuum suction. Sample vessels 280 and / or 290 can be configured to be fluidly coupled to second and third outlet ports 231 and 232, respectively, of collection device 200 in any suitable manner (either directly or via an intervening structure, such as sterile flexible tubing). Sample reservoirs 280 and / or 290 can be moved relative to outlet ports 231 and / or 232 to place them in fluid communication with outlet ports 231 and / or 232. Sample reservoirs 280 and 290 can be configured to contain a second or third volume of bodily fluid. The second or third volume of bodily fluid can be a predetermined or undetermined volume, thereby fluidly isolating the second or third volume of bodily fluid from the first volume of bodily fluid drawn from the patient. In some configurations, sample reservoirs 280 and / or 290 can be coupled to collection device 200 by being integrally formed with housing 201, similar to pre-sample reservoir 270, and therefore will not be described in detail herein. In some cases, sample reservoirs 280 and / or 290 may be transparent, allowing the user visual feedback to confirm the flow of bodily fluid into sample reservoirs 280 and / or 290.

[0048]

[1101] In some embodiments, the sample reservoirs 280 and 290 and the flow diversion mechanism 220 (and / or portions of the collection device 200 other than the sample reservoirs 280 and 290) are formed separately (e.g., not integrally formed) and are coupled together, for example, during a manufacturing process. In some cases, the sample reservoirs 280 and 290 can be coupled to the flow diversion mechanism 220 in a substantially sterile or sealed environment (e.g., an environment filled with ethylene oxide, etc.). Thus, the interface between the sample reservoirs 280 and 290 and the flow diversion mechanism 220 is substantially sterilized prior to use. Furthermore, the collection device 200 can be shipped and / or stored in a pre-assembled manner, such as to maintain a substantially sterile interface between the sample reservoirs 280 and 290 and the flow diversion mechanism 220.

[0049]

[1102] As shown in FIGS. 6 and 7 , the flow controller 240 includes a first member 241 and a second member 245. The first member 241 is configured to be disposed within a recess 266 (see, e.g., FIG. 4 ) of the housing 201, and the first member 241 can be made of any biocompatible material, such as titanium, graphite, pyrolytic carbon, polyester, polycarbonate, polyurethane, or an elastomeric material. In some embodiments, the second member 245 acts as an actuator that moves the first member 241 from a first configuration to a second configuration. More specifically, when the first member 241 is disposed within the recess 266, the second member 245 can be moved between a first position and a second position to move the flow controller 240 between the first and second configurations. In some embodiments, the housing 201 can selectively limit the movement of the second member 245 from its first position to its second position. In some embodiments, the housing 201 can be configured to prevent movement of the second member 245 once it has been moved to the second position. In other words, the housing 201 can include a locking mechanism that prevents the second member 245 from moving from the second position back to the first position. The second member 245 and / or the housing 201 can also include mechanical detents and / or other indicators that provide visual or tactile feedback to ensure correct positioning of the second member 245.

[0050]

[1103] The first member 241 can include multiple channels that direct fluid flow following venipuncture (and / or other methods of accessing a patient's bodily fluids). For example, as shown in FIGS. 6 and 7, the first member 241 includes a first flow path 242 and a second flow path 244. When the second member 245 is in a first position (see, e.g., FIGS. 8 and 9), the flow controller 240 is configured in a first configuration, and the first flow path 242 establishes fluid communication between the inlet port 221 and the first outlet port 230 while fluidly isolating the inlet port 221 from the internal flow path 235. When the second member 245 is in a second position (see, e.g., FIGS. 10-13), the flow controller 240 is configured in a second configuration, and the second flow path 244 establishes fluid communication between the inlet port 221 and the internal flow path 235 while fluidly isolating the inlet port 221 from the first outlet port 230. Additional first member 241 flow paths and / or additional second member 245 positions corresponding to configurations of flow controller 240 can be included to further direct / isolate fluid flow between the patient and collection device 200. For example, second member 245 can have a third position corresponding to a third configuration of flow controller 240 that substantially prevents fluid flow entirely between the patient and collection device 200. In other words, in some embodiments, after all of the bodily fluid sample has been removed from the patient, the dial can be moved to the third position to substantially seal the sample within collection device 200 from the external environment.

[0051]

[1104] In operation, the collection device 200 can be used to collect bodily fluids (e.g., blood) from a patient with reduced contamination from microorganisms present on the skin and / or other undesirable external contaminants. For example, the inlet port 221 of the collection device 200 is fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) via the adapter 204. Following venipuncture (or other bodily fluid access method), the second member 245 is rotated until it reaches a first position, as shown in FIGS. 8 and 9 . Alternatively, the second member 245 can be preset to the first position, and the collection device 200 can be sealed in other ways to maintain the vacuum within the pre-sample reservoir 270 and the sterility of the collection device 200. For example, the inlet port 221 and / or the adapter 204 can include a valve that opens when the collection device 200 is coupled to a needle or other lumen-defining device.

[0052]

[1105] As described above, when second member 245 is in the first position, flow controller 240 is placed in the first configuration, and first flow path 242 of first member 241 establishes fluid communication between inlet port 221 and first outlet port 230 while fluidly isolating inlet port 221 from internal flow path 235. Furthermore, first sample reservoir 280 and second sample reservoir 290 are fluidly isolated from inlet port 221 in the first configuration, defining a fluid flow path between a portion of the patient's body (e.g., a vein) and pre-sample reservoir 270, as shown by arrow AA in FIG. As described above, fluid reservoirs used in collection device 200, such as pre-sample reservoir 270 and sample reservoirs 280 and 290, are configured to define a negative pressure (i.e., a pressure less than the fluid pressure of the portion of the body from which collection device 200 is being used to draw bodily fluid) such that, when fluid communication is established between a portion of a patient's body (e.g., a vein) and pre-sample reservoir 270, the negative pressure within pre-sample reservoir 270 causes bodily fluid to be drawn into pre-sample reservoir 270 due to the pressure differential between pre-sample reservoir 270 and that portion of the patient's body. In this first configuration, flow controller 240 also fluidly isolates pre-sample reservoir 270 from internal flow path 235. Thus, a first amount (predetermined or undetermined) of bodily fluid can be received into pre-sample reservoir 270 immediately after (e.g.,) venipuncture and isolated from subsequent samples. In this manner, collection device 200 can be used to prevent a first volume of bodily fluid that is most likely to contain surface microorganisms and / or other undesirable external contaminants from contaminating subsequent volumes of bodily fluid sample that are collected and used for diagnostic or other tests that may be affected by the contaminants.

[0053]

[1106] Following collection of the volume of bodily fluid pre-sample in pre-sample reservoir 270, second member 245 can be rotated until it reaches a second position as shown in Figures 10 and 11. When second member 245 is in the second position, flow controller 240 is disposed in a second configuration, and second flow path 244 of first member 241 establishes fluid communication between inlet port 221 and internal flow path 235 while fluidly isolating first outlet port 230 (i.e., pre-sample reservoir 270) from inlet port 221. In other words, in the second configuration, flow controller 240 establishes a fluid flow path between a portion of the patient's body (e.g., a vein) and internal flow path 235 via second flow path 244, as shown by arrow BB in Figure 11.

[0054]

[1107] With flow controller 240 in the second configuration, movable member 250 and / or 250′ can be actuated (i.e., depressed) by a user from a first position to a second position to establish fluid communication between a portion of a patient's body (e.g., a vein) and first sample reservoir 280 and / or second sample reservoir 290. More specifically, movable member 250 moves from its first position to its second configuration such that piercing member 255 passes through outlet port 231 such that piercing member 255 can pierce vacuum seal 284 of first sample reservoir 280 and be positioned within sample container 282, as shown by arrow CC in FIG. When in the second position, the inlet port 253 and the outlet port 254 of the movable member 250 are substantially aligned with and in fluid communication with the internal flow path 235, thereby allowing bodily fluid to flow from the internal flow path 235 into the internal cavity 252 of the movable member 250 and out the lumen 256 of the piercing member 255 into the first sample reservoir 280. A pressure difference between the sample reservoir 280 (e.g., a vacuum or negative pressure) and the internal flow path 235 draws bodily fluid into the sample reservoir 280. In other words, in the second configuration, the movable member 250 establishes a fluid flow path between the internal flow path 235 and the first sample reservoir 280, as shown by arrow DD in FIG. 12 . Once a desired amount (e.g., a second amount) of bodily fluid has collected in the first sample reservoir 280, the user can release the movable member 250 to allow the biasing member 259 to move the button back to its first position. When movable member 250 returns to its first position, piercing member 255 is removed from first sample reservoir 280 and seal 284 (e.g., a self-sealing septum) fluidly isolates first sample reservoir 280 from internal flow path 235.

[0055]

[1108] Similarly, while flow controller 240 is in the second configuration, movable member 250′ can be actuated (depressed) by a user from its first position to its second position, as shown by arrow EE in FIG. 13 . In this manner, fluid communication is established between a portion of a patient's body (e.g., a vein) and second sample reservoir 290 (via outlet port 232) in a manner similar to that described above for movable member 250 and first sample reservoir 280. In other words, in the second configuration, movable member 250′ establishes a fluid flow path between internal flow path 235 and second sample reservoir 290, as shown by arrow FF in FIG. 13 . Once a desired amount (e.g., a third amount) of bodily fluid has been collected in second sample reservoir 290, the user can release movable member 250′ to allow biasing member 259′ to move button 250′ back to its first position. Although shown and described as being a sequential process, the order and / or sequencing of filling is not necessarily required (i.e., sample reservoir 280 does not necessarily have to be filled before sample reservoir 290, etc.). In other words, when flow controller 240 moves to the second configuration, first sample reservoir 280 and second sample reservoir 290 (and any additional sample reservoirs) can be filled in any order, at the same time (e.g., simultaneously) and / or at overlapping time intervals. For example, a user can begin filling first sample reservoir 280, and then, after first sample reservoir 280 is partially filled, the user can depress movable member 250′ to begin filling second sample reservoir 290 while first sample reservoir 280 finishes filling. Additionally, adjustment of the volume of bodily fluid collected in sample reservoirs 280 and / or 290 may be enabled by repeatedly actuating (inserting) movable members 250 and / or 250'. As noted above, second member 245 may have a third position corresponding to a third configuration of flow controller 240, which may substantially prevent fluid flow between the patient and collection device 200 entirely, thereby substantially sealing the sample within collection device 200 from the external environment.

[0056]

[1109] 2-13, the collection device 200 may include a flow metering device or the like that may be configured to meter the volume of bodily fluid transferred to the pre-sample reservoir 270, the first sample reservoir 280, and / or the second sample reservoir 290. For example, in some embodiments, the first member 241 of the flow controller 240 may include a flow metering device in fluid communication with the first flow path 242 and the second flow path 244. In other embodiments, the flow metering device may be disposed within the internal cavity 252 of the movable member 250 and / or 250′. Thus, the volume of the bodily fluid sample transferred to and disposed in the first sample reservoir 280 and the second sample reservoir 290 may be metered and / or controlled such that the volume of the bodily fluid sample disposed in each sample reservoir 280 and 290 is a predetermined volume, e.g., 10 mL, 20 mL, 30 mL, etc.

[0057]

[1110] Although collection device 200 is shown and described as including first sample reservoir 280 and second sample reservoir 290, in other embodiments, it may include any number of pre-sample reservoirs and / or sample reservoirs. For example, Figures 14 and 15 show collection device 300 according to an embodiment. As shown, some aspects of collection device 300 may be substantially similar to corresponding aspects of collection device 200 described above with reference to Figures 2-13. Accordingly, similar aspects will not be described in further detail herein.

[0058]

[1111] 14 and 15 , collection device 300 includes flow splitter mechanism 320, flow controller 340, pre-sample reservoir 370, first sample reservoir 380, second sample reservoir 380′, third sample reservoir 390, and fourth sample reservoir 390′. Pre-sample reservoir 370 can be substantially similar to pre-sample reservoir 270, described in detail above. In some embodiments, sample reservoirs 380, 380′, 390, and 390′ can be substantially similar to sample reservoirs 280 and 290, described in detail above. In some embodiments, sample reservoirs 380, 380′, 390, and 390′ can have substantially the same shape and size and can contain substantially the same culture medium, for example. In other embodiments, sample reservoirs 380, 380′, 390, and 390′ can have substantially the same shape and size and can contain one of an aerobic culture medium or an anaerobic culture medium. For example, in some embodiments, first sample reservoir 380 and third sample reservoir 390 can contain aerobic media, and second sample reservoir 380' and fourth sample reservoir 390' can contain anaerobic media. In other embodiments, sample reservoirs 380, 380', 390, and 390' can each contain aerobic or anaerobic media in any arrangement or combination.

[0059]

[1112] Flow diverter mechanism 320 includes a housing 301 and a set of movable members 350, 350', 350", and 350'". Movable members 350, 350', 350", and 350'" are substantially similar to movable member 250 described above, for example, with reference to FIG. 5. As such, movable members 350, 350', 350", and 350'" can be moved between first and second positions relative to housing 301 so as to be positioned in fluid communication with sample reservoirs 380, 380', 390, and 390', respectively. Housing 301 includes inlet port 321, first outlet port 330 configured to be positioned in fluid communication with pre-sample reservoir 370, second outlet port 331 configured to be positioned in fluid communication with first sample reservoir 380, third outlet port 332 configured to be positioned in fluid communication with second sample reservoir 380′, fourth outlet port 333 configured to be positioned in fluid communication with third sample reservoir 390′, and fifth outlet port 334 configured to be positioned in fluid communication with fourth sample reservoir 390′. Additionally, housing 301 defines an internal flow path 335 that can be selectively positioned in fluid communication with inlet port 321 and outlet ports 331, 332, 333, and 334 in a manner similar to that described above with respect to internal flow path 235 of housing 201.

[0060]

[1113] Flow controller 340 is substantially similar to flow controller 240 described above, for example, with reference to Figures 6-13. Accordingly, flow controller 340 can be rotated between a first configuration and a second configuration to selectively define a portion of a fluid flow path between a patient and pre-sample reservoir 370 or sample reservoirs 380, 380', 390, and 390'. In this manner, a user can operate collection device 300 in a manner similar to that described above with respect to collection device 200 in Figures 8-13. Accordingly, a first volume of bodily fluid can be transferred and disposed in pre-sample reservoir 370, and subsequent volumes of bodily fluid can be transferred and disposed in sample reservoirs 380, 380', 390, and 390'.

[0061]

[1114] 16-22 illustrate a collection device 400 according to an embodiment. The collection device 400 includes a flow diverter mechanism 420, a flow controller 440, and sample reservoirs 480, 480′, 490, and 490′. As described further herein, the collection device 400 can be moved between a first configuration, a second configuration, a third configuration, a fourth configuration, and a fifth configuration to deliver a flow of bodily fluid that is substantially free of extracorporeal microorganisms, such as microorganisms present on the skin and / or other undesirable external contaminants. The collection device 400 can be of any suitable shape, size, or configuration. For example, while the sample reservoirs 480, 480′, 490, and 490′ are shown oriented perpendicularly relative to the housing 401 in FIGS. 16-22, the collection device 400 can have the sample reservoirs 480, 480′, 490, and 490′ oriented in any suitable plane relative to the housing 401, or arranged conically relative to the housing 401, etc.

[0062]

[1115] Sample reservoirs 480, 480', 490, and 490' are substantially similar or identical in form and function to sample reservoirs 280 and / or 290 of collection device 200 and, therefore, will not be described in detail herein. As described above, sample reservoirs 480, 480', 490, and 490' maintain a negative pressure (vacuum) that can allow bodily fluid to be drawn from a patient into sample reservoirs 480, 480', 490, and 490' via suction. In some embodiments, sample reservoirs 480 and 480' can be aerobic culture bottles and sample reservoirs 490 and 490' can be anaerobic culture bottles, and collection device 400 can be used to collect multiple aerobic and anaerobic blood culture samples from a single venipuncture. As described in more detail herein, sample reservoirs 480, 480', 490, and 490' can each be positioned in fluid communication with at least a portion of flow diversion mechanism 420 to receive a volume of a bodily fluid sample. The volume of the bodily fluid sample can be predetermined or undetermined. Furthermore, once a desired volume of bodily fluid has been placed in sample reservoir 480, 480', 490, and 490', each sample reservoir 480, 480', 490, and 490' can be fluidly isolated from at least a portion of flow diversion mechanism 420, as described in more detail herein.

[0063]

[1116] The flow diverter mechanism 420 includes a housing 401 and a distribution member 429. The housing 401 of the flow diverter mechanism 420 is physically and fluidly coupled to the distribution member 429 to provide and / or define a set of fluid flow paths for collecting bodily fluid from the patient. The housing 401 defines a recess 466 and a set of outlet openings 403. The recess 466 is configured to receive a seal member 441 included in the flow controller 440, as described in further detail herein. The set of outlet openings 403 includes a first outlet opening 403a, a second outlet opening 403b, a third outlet opening 403c, a fourth outlet opening 403d, and a fifth outlet opening 403e, each configured to define a different fluid flow path in fluid communication with a different portion of the distribution member 429. More specifically, the distribution member 429 defines and / or forms at least a portion of the pre-sample reservoir 470 in fluid communication with the first outlet opening 403a, a first flow path 435a in fluid communication with the second outlet opening 403b, a second flow path 435b in fluid communication with the third outlet opening 403, a third flow path 435c in fluid communication with the fourth outlet opening 403d, and a fourth flow path 435 in fluid communication with the fifth outlet opening 403e.

[0064]

[1117] 17 and 18, the distribution member 429 defines a chamber or space that defines at least a portion of the pre-sample reservoir 470. The pre-sample reservoir 470 is configured to contain a bodily fluid, such as blood, plasma, or urine. The first outlet opening 403a of the housing 401 can be substantially aligned with the open portion of the pre-sample reservoir 470 to allow the pre-sample reservoir 470 to receive a flow of bodily fluid from a patient. For example, the pre-sample reservoir 470 can receive and contain a first amount or volume of bodily fluid, where the first amount of bodily fluid can be a predetermined amount or an undetermined amount. Furthermore, the flow diverter mechanism 420 can be configured to maintain the pre-sample reservoir 470 in fluid isolation from the flow paths 435a, 435b, 435c, and 435d and / or a subsequent volume of bodily fluid drawn from the patient, as described in further detail herein. Although pre-sample reservoirs 270 and 370 are described above as maintaining a negative pressure, pre-sample reservoir 470 does not maintain a negative pressure (vacuum) and therefore other mechanisms, such as gravity, can be used to draw bodily fluid into pre-sample reservoir 470.

[0065]

[1118] The flow paths 435a-435d extend radially from the center of the distribution member 429 and are arranged such that each of the flow paths 435a, 435b, 435c, and 435d is fluidically isolated from the pre-sample reservoir 470 and the other flow paths. As such, the flow paths 435a, 435b, 435c, and 435d can be oriented and / or otherwise defined as fluid flow paths between first and second ends that are substantially aligned with the outlet openings 403b, 403c, 403d, and 403e, respectively. As shown in FIGS. 17 and 18, the distribution member 429 defines a first outlet port 431 disposed at the second end of the first flow path 435a, a second outlet port 432 disposed at the second end of the second flow path 435b, a third outlet port 433 disposed at the second end of the third flow path 435c, and a fourth outlet port 434 disposed at the second end of the fourth flow path 435d. Additionally, distribution member 429 includes first piercing member 455a, second piercing member 455b, third piercing member 455c, and fourth piercing member 455d, which are physically and fluidly coupled to first outlet port 431, second outlet port 432, third outlet port 433, and fourth outlet port 434, respectively. Thus, piercing members 455a-d can be used to pierce the vacuum seals of sample reservoirs 480, 480', 490, and 490', thereby initiating the flow of bodily fluid, as described in further detail herein. Although not shown in Figures 17 and 18, sample reservoirs 480, 480', 490 and 490' may be physically coupled to a portion of distribution member 429 (either directly or via an intervening structure such as a sterile flexible tube) in any suitable manner that allows sample reservoirs 480, 480', 490 and 490' to be positioned in fluid communication with outlet ports 431, 432, 433 and 434, respectively.

[0066]

[1119] Flow controller 440 includes a dial 445 and a seal member 441. Seal member 441 is disposed within a recess 466 of housing 401 (see, for example, FIG. 20 ). More specifically, flow controller 440 can be coupled to housing 401 such that seal member 441 is disposed between and in contact with a surface of housing 401 that defines recess 466 and a surface of dial 445. Furthermore, seal member 441 can have a size and shape such that, when flow controller 440 is coupled to housing 401, seal member 441 forms a substantially fluid-tight seal with a surface of dial 445 and a surface of housing 401 that defines recess 466, as described in more detail herein. The sealing member 441 can be made from any material that is biocompatible, such as, for example, silicone, polylactic acid, polyglycolic acid, polylactic-co-glycolic acid (PLGA), polyanhydrides, polyorthoesters, polyetheresters, polycaprolactone, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethane, nylon, polyester, polycarbonate, polyacrylate, ethylene-vinyl acetate and other acyl-substituted cellulose acetate polymers, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene oxide, and / or mixtures and copolymers thereof.

[0067]

[1120] 17 , seal member 441 defines a set of openings 444 through which the flow of bodily fluid can be directed following venipuncture (or other method of accessing bodily fluid). For example, the set of openings 444 defined by seal member 441 includes a first opening 444 a, a second opening 444 b, a third opening 444 c, a fourth opening 444 d, and a fifth opening 444 e. Seal member 441 is positioned such that, when seal member 441 is positioned within recess 446, first opening 444 a, second opening 444 b, third opening 444 c, fourth opening 444 d, and fifth opening 444 e are substantially aligned with first outlet opening 403 a, second opening 403 b, third opening 403 c, fourth opening 403 d, and fifth opening 403 e, respectively, of housing 401.

[0068]

[1121] A dial 445 of the flow controller 440 is rotatably coupled to the housing 401 and is movable relative to the housing 401 between a first position, a second position, a third position, a fourth position, and a fifth position. The dial 445 includes an inlet port 421 that defines a lumen 402. The inlet port 421 can be fluidly coupled to a medical device (not shown) that defines a fluid flow path for withdrawing and / or transporting bodily fluid from a patient's body to the collection device 400. For example, the inlet port 421 can be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) directly or indirectly via an adapter 404. Similarly, the inlet lumen 402 defined by the inlet port 421 is disposed in fluid communication with a lumen defined by the lumen-defining device when the lumen-defining device is coupled to the inlet port 421. In this manner, the inlet port 421 can be configured to selectively position the pre-sample reservoir 470, the first sample reservoir 480, the second sample reservoir 480', the third sample reservoir 490 and the fourth sample reservoir 490' in fluid communication with the patient, as described in further detail herein.

[0069]

[1122] As described above, dial 445 is movable among a first position, a second position, a third position, a fourth position, and a fifth position. When dial 445 is in the first position, flow controller 440 is disposed in a first configuration, such that inlet port 421 is substantially aligned with first opening 444a of seal member 441 and first outlet opening 403a of housing 401. In this manner, first opening 444a of seal member 441 fluidly isolates inlet port 421 from outlet openings 403b, 403c, 403d, and 403e, thereby establishing fluid communication between inlet port 421 and first outlet opening 403a while fluidly isolating inlet port 421 from flow paths 435a-d. When first outlet port 403a is aligned with the open portion of pre-sample reservoir 470, first opening 444a and first outlet opening 403a establish fluid communication between inlet port 421 and pre-sample reservoir 470. When dial 445 is rotated (or actuated) to a second position, flow controller 440 is placed in a second configuration and second outlet opening 444b establishes fluid communication between inlet port 421 and second outlet opening 403b while fluidly isolating inlet port 421 from outlet openings 403a, 403c, 403d, and 403e. When second outlet opening 403b is aligned with the first end of first flow path 435a, second opening 444b and second outlet opening 403b establish fluid communication between inlet port 421 and first flow path 435a.

[0070]

[1123] The collection device 400 operates similarly when the dial 445 is rotated to the third, fourth, and fifth positions. Thus, when the inlet lumen 402 is placed in fluid communication with the patient (e.g., via a medical device coupled to the inlet port 421), the first outlet port 430, the second outlet port 431, the third outlet port 432, the fourth outlet port 433, and the fifth outlet port 434 can be selectively placed in fluid communication with the inlet lumen 402 to allow all of the bodily fluid to flow into at least one of the pre-sample reservoirs 470 or one or more of the sample reservoirs 480, 480', 490, and 490'. In some embodiments, additional seal outlet openings and / or additional dial 445 positions corresponding to the configuration of the flow controller 440 can be included to further direct / isolate fluid flow between the patient and the collection device 400. For example, the dial 445 can have a sixth position corresponding to a sixth configuration of the flow controller 440 that substantially prevents fluid flow overall between the patient and the collection device 400. In other words, in some embodiments, after all of the bodily fluid sample has been removed from the patient, the dial 445 can be moved to the sixth position to substantially seal the sample within the collection device 400 from the external environment.

[0071]

[1124] In some embodiments, bodily fluid is prevented from flowing to an outlet port associated with a sample reservoir (e.g., outlet ports 431-434) until after a predetermined volume of bodily fluid has been collected in pre-sample reservoir 470. In some embodiments, the outlet ports associated with the sample reservoirs (e.g., outlet ports 431-434) can be arranged to be in fluid communication with inlet lumen 402 only sequentially (e.g., outlet port 431 must be in fluid communication with inlet lumen 402 before outlet port 432, etc.). In some embodiments, the outlet ports associated with subsequent sample reservoirs (e.g., outlet ports 432-434) can be arranged to be in fluid communication with inlet lumen 402 only after a determined volume of bodily fluid has been collected. In some embodiments, the outlet ports associated with the sample reservoirs (e.g., outlet ports 431-434) can be arranged to be fluidly connected to the inlet lumen 402 in any random manner without any order preference (e.g., outlet port 434 can be fluidly connected to the inlet lumen 402 before outlet port 431, outlet port 432 can be fluidly connected to the inlet lumen 402 before outlet port 433, etc.).

[0072]

[1125] In some embodiments, housing 401 can selectively limit movement of dial 445 from its first position to its second, third, fourth, and fifth positions. In some embodiments, housing 401 can be configured to prevent movement of dial 445 once it has moved to the fifth position. In other words, housing 401 can include a locking mechanism that prevents dial 445 from moving from the fifth position back to the first position. Dial 445 and / or housing 401 can also include mechanical detents and / or other indicators that provide visual or tactile feedback to ensure correct positioning of dial 445 relative to outlet openings 403a-403e of housing 401.

[0073]

[1126] In operation, the collection device 400 can be used to collect bodily fluids (e.g., blood, plasma, urine, etc.) from a patient with reduced contamination. For example, the inlet port 421 of the collection device 400 can be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). Following venipuncture (or other method of accessing bodily fluids), the dial 445 is actuated (or turned) until it reaches a first position, as shown in FIGS. 19 and 20 . Alternatively, the dial 445 can be preset to the first position, and the collection device 400 can be sealed in other ways to maintain the sterility of the collection device 400. For example, the inlet port 421 can include a valve that opens when the collection device 400 is coupled to a needle or other lumen-defining device.

[0074]

[1127] As described above, when dial 445 is in the first position, flow controller 440 is placed in a first configuration, and first opening 444a of seal member 441 establishes fluid communication between inlet port 421 and first outlet port 430 (contained within housing 401) while fluidly isolating inlet port 421 from the four flow paths 435a-d. Additionally, sample reservoirs 480, 480', 490, and 490' are fluidly isolated from inlet port 421 in the first configuration, defining a fluid flow path between a portion of the patient's body (e.g., a vein) and pre-sample reservoir 470, as shown by arrows GG in FIG. 20 . In this first configuration, bodily fluid flows (e.g., by gravity, vacuum, etc.) from that portion of the patient's body through inlet lumen 402 of inlet port 421, first opening 444a of seal member 441, first outlet port 430, and into pre-sample reservoir 470. In the first configuration, the flow controller 440 also fluidly isolates the pre-sample reservoir 470 from the flow paths 435a-335d. Thus, a first volume (predetermined or undetermined) of bodily fluid can be received into the pre-sample reservoir 470 immediately after venipuncture and isolated from subsequent samples. In this manner, the collection device 400 can be used to prevent the first volume of bodily fluid, which is most likely to contain surface microorganisms and / or other undesirable external contaminants, from contaminating subsequent volumes of bodily fluid sample collected and used for diagnostic or other tests that may be affected by the contaminants.

[0075]

[1128] Following collection of the bodily fluid pre-sample in pre-sample reservoir 470, dial 445 can be actuated (rotated) until it reaches a second position, as shown in FIGS. 21 and 22 . When dial 445 is in the second position, flow controller 440 is placed in the second configuration, and second opening 444b of seal member 441 fluidly isolates pre-sample reservoir 470 from inlet port 421 while establishing fluid communication between inlet port 421 and flow path 435a. In other words, in the second configuration, flow controller 440 establishes a fluid flow path between a portion of the patient's body (e.g., a vein) and flow path 435a, as shown by arrows HH in FIG. 22 . With flow controller 440 in the second configuration, sample reservoir 480 can be actuated (e.g., by pushing piercing member 455a) by a user from the first configuration to the second configuration to establish fluid communication between a portion of the patient's body (e.g., a vein) and first sample reservoir 480.

[0076]

[1129] As described above, moving the sample reservoir 480 to the second configuration positions the piercing member 455a inside the sample reservoir 480, piercing the vacuum seal of the sample reservoir 480. In this second configuration, a portion of the patient's body (e.g., a vein) is exposed to a vacuum suction force from the sample reservoir 480 due to the negative pressure (vacuum) within the sample reservoir 480. The pressure difference between the sample reservoir 480 (e.g., vacuum or negative pressure) and the portion of the patient's body draws bodily fluid into the sample reservoir 480. The bodily fluid flows from the portion of the patient's body through the inlet lumen 402 of the inlet port 421, the second opening 444b of the seal member 441, the second outlet opening 403b of the housing 401, and into the first flow path 435a. The vacuum suction draws a flow of bodily fluid through the first flow path 435a, through the second outlet port 431, and through the piercing member 455a into the sample reservoir 480. In other words, in the second configuration, the flow controller 440 establishes a fluid flow path between the inlet port 421 and the sample reservoir 480. Once a desired amount (e.g., the second amount) of bodily fluid has collected in the sample reservoir 480, a user can actuate (rotate) the flow controller 440 to a third position and / or move the sample reservoir 480 back to its first configuration to isolate the first sample reservoir 480 from the flow path 435a. When the sample reservoir 480 returns to the first configuration, the piercing member 455a is removed from the sample reservoir 480, and a seal (e.g., a self-sealing membrane) of the sample reservoir 480 isolates the first sample reservoir 480 from the flow path 435a. Filling of the other sample reservoirs is similarly accomplished with flow controller 440 positioned in the third, fourth, and fifth configurations, respectively.

[0077]

[1130] It should be noted that the order and / or sequencing of filling is not necessarily required (i.e., sample reservoir 480 does not necessarily have to be filled before sample reservoir 490, etc.). In other words, first sample reservoir 480 and second sample reservoir 490 (and any additional sample reservoirs) can be filled in any order. For example, a user can begin filling first sample reservoir 480, and then, after first sample reservoir 480 is partially filled, the user can fill second sample reservoir 490. Furthermore, repeated filling of sample reservoirs 480 and / or 490 can allow adjustment of the volume of bodily fluid collected in sample reservoirs 480 and / or 490. However, in other embodiments, the order of filling can be manipulated mechanically, such as by not allowing access to the second sample reservoir until a specified amount of bodily fluid has been confirmed to have been placed in the first reservoir. As described above, the dial 445 can have a sixth position for a sixth configuration of the flow controller 440 that can substantially prevent fluid flow between the patient and the collection device 400 as a whole, thereby substantially sealing the sample within the collection device 400 from the external environment.

[0078]

[1131] Although collection device 400 is shown and described above as including and / or otherwise coupled to a set of four sample reservoirs (e.g., first sample reservoir 480, second sample reservoir 480′, third reservoir 490, and fourth reservoir 490′), in other embodiments, the collection device can include and / or be coupled to any suitable number of sample reservoirs. For example, FIGS. 23-25 ​​show collection device 500 according to an embodiment. As shown, some aspects of collection device 500 can be substantially similar to corresponding aspects of collection device 500 described above with reference to FIGS. 16-22. Accordingly, similar aspects will not be described in further detail herein.

[0079]

[1132] The collection device 500 includes a flow splitter mechanism 520, a flow controller 540, a first sample reservoir 580, and a second sample reservoir 590. The sample reservoirs 580 and 590 can be substantially similar to the sample reservoirs described in detail above. In some embodiments, the sample reservoirs 580 and 590 can have substantially the same shape and size and can contain substantially the same medium. In other embodiments, the sample reservoirs 580 and 590 can have substantially the same shape and size and can contain one of an aerobic medium or an anaerobic medium. In still other embodiments, the first sample reservoir 580 can have a first size that is substantially larger than the size of the second sample reservoir 590.

[0080]

[1133] 24 and 25 , the flow diverter mechanism 520 includes a housing 501 and a distribution member 529. The housing 501 of the flow diverter mechanism 520 is physically and fluidly coupled to the distribution member 529 to provide and / or define a set of fluid flow paths for collecting bodily fluid from the patient. As described above with respect to the housing 401, the housing 501 can define a recess and first, second, and third outlet openings 503 a, 503 b, and 503 c. The recess is configured to receive a seal member 541 included in the flow controller 540, as described in detail above. The first, second, and third outlet openings 503 a, 503 b, and 503 c can be substantially similar in form and function to the first, second, and third outlet openings 403 a, 403 b, and 403 c, respectively, defined by the housing 401. Similarly, the distribution member 529 defines a pre-sample reservoir 470, a first flow path 435a, and a second flow path 435b that are substantially similar to the pre-sample reservoir 470, the first flow path 435a, and the second flow path 435b included in the flow dividing member 429. Thus, as described above with respect to the flow dividing mechanism 420, the pre-sample reservoir 570 is in fluid communication with the first outlet opening 503a, the first flow path 535a is in fluid communication with the second outlet opening 503b, and the second flow path 535b is in fluid communication with the third outlet opening 503c. As shown in FIG. 25 , the distribution member 529 defines a first outlet port 531 in fluid communication with the first flow path 535a and the first piercing member 555a, and a second outlet port 532 in fluid communication with the second flow path 535b and the second piercing member 555b. As mentioned above, piercing members 555a and 555b can be used to puncture the vacuum seals of sample reservoirs 580 and 590, thereby initiating the flow of bodily fluids, as described in more detail herein.

[0081]

[1134] Flow controller 540 includes a dial 545 and a seal member 541. Seal member 541 is disposed within a recess in housing 501, as described above. As such, when flow controller 540 is coupled to housing 501, seal member 541 forms a substantially fluid-tight seal with a surface of dial 545 and a surface of housing 501 that defines the recess. As shown in FIGS. 24 and 25 , seal member 541 defines first, second, and third openings 544 a, 544 b, and 544 c that substantially align with first, second, and third outlet openings 503 a, 503 b, and 503 c, respectively, as described in detail above with respect to seal member 441.

[0082]

[1135] The dial 545 of the flow controller 540 may be substantially similar in form and function to the dial 445, while being sized appropriately to be coupled to the housing 501. Thus, the dial 545 may be rotatably coupled to the housing 501 and movable relative to the housing 501 between a first position, a second position, and a third position. The dial 545 includes an inlet port 521 defining a lumen 502, and the inlet port 521 may be fluidly coupled to a medical device (not shown) defining a fluid flow path for withdrawing bodily fluid from a patient and / or transporting it to the collection device 500. In this manner, the inlet port 521 may be configured to selectively position the pre-sample reservoir 570, the first sample reservoir 580, and the second sample reservoir 590. More particularly, when the dial 545 is in the first position, the flow controller 540 is disposed in the first configuration, and the inlet port 521 is substantially aligned with the first opening 544a of the seal member 541 and the first outlet opening 503a of the housing 501. Thus, as described in detail above with respect to collection device 400, first opening 544a of seal member 541 establishes fluid communication between inlet port 521 and first outlet opening 503a, thus placing inlet port 521 in fluid communication with pre-sample reservoir 570. Similarly, when dial 545 is turned (or actuated) to the second position, flow controller 540 is placed in the second configuration and second outlet opening 544b establishes fluid communication between inlet port 521 and second outlet opening 503b and thus first flow path 535a, and when dial 545 is turned to the third position, flow controller 540 is placed in the third configuration and third outlet opening 544c establishes fluid communication between inlet port 521 and third outlet opening 503c and thus second flow path 535a. In this manner, as described in detail above with respect to collection device 400, collection device 500 can be used to transfer a first volume of bodily fluid to pre-sample 570, and then to transfer second and third volumes of bodily fluid to first sample reservoir 580 and second sample reservoir 590, respectively.

[0083]

[1136] 26-33 illustrate a collection device 600 according to an embodiment. The collection device 600 includes a flow diverter mechanism 620, a flow controller 640, and sample reservoirs 680, 680′, 690, and 690′. As described further herein, the collection device 600 can be moved between a first configuration, a second configuration, a third configuration, a fourth configuration, and a fifth configuration to deliver a flow of bodily fluid that is substantially free of extracorporeal microorganisms, such as microorganisms present on the skin and / or other undesirable external contaminants. The collection device 600 can be of any suitable shape, size, or configuration. For example, aspects and / or portions of the collection device 600 can be similar in form and / or function to corresponding aspects and / or portions of any of the collection devices 100, 200, 300, 400, and / or 500 described above. Accordingly, such similar aspects and / or portions will not be described in further detail herein. By way of example, in some embodiments, sample reservoirs 680, 680', 690 and 690' of collection device 600 may be substantially similar and / or identical in form and / or function to sample reservoirs 480, 480', 490 and 490', respectively, included in collection device 400 of Figures 16-22.

[0084]

[1137] Flow distribution mechanism 620 includes a distribution member 629 and a set of coupling members 637a, 637b, 637c, and 637d (see, e.g., FIG. 27). Distribution member 629 is in fluid communication with coupling members 637a, 637b, 637c, and 637d and is configured to provide and / or define a set of fluid flow paths for collecting bodily fluid from a patient. As shown in FIGS. 27 and 28, distribution member 629 defines and / or forms a first outlet port 630 in fluid communication with pre-sample reservoir 670, a second outlet port 631 in fluid communication with first coupling member 637a, a third outlet port 632 in fluid communication with second coupling portion 637b, a fourth outlet port 633 in fluid communication with third coupling portion 637c, and a fifth outlet port 634 in fluid communication with fourth coupling portion 637d.

[0085]

[1138] 28 , distribution member 629 defines a chamber or space that defines at least a portion of pre-sample reservoir 670. Pre-sample reservoir 670 is configured to contain a bodily fluid, such as blood, plasma, urine, or the like. For example, pre-sample reservoir 670 can receive and contain a first amount or volume of bodily fluid from a patient, where the first amount of bodily fluid can be a predetermined or undetermined amount. Furthermore, the arrangement of flow diverter mechanism 620 and flow controller 640 can be such that pre-sample reservoir 670 is maintained in fluid isolation from coupling portions 637 a, 637 b, 637 c, and 637 d and / or subsequent volumes of bodily fluid drawn from the patient, as described in further detail herein. In this manner, outlet ports 631, 632, 633, and 634 can direct and / or otherwise define a fluid flow path between flow controller 640 and coupling members 637a, 637b, 637c, and 637d, respectively, as described in further detail herein. In some embodiments, the arrangement of first outlet port 630 and pre-sample reservoir 670 can be substantially similar in form and function to pre-sample reservoirs 470 and / or 570. Accordingly, pre-sample reservoir 670 will not be described in further detail herein.

[0086]

[1139] As shown in FIG. 29 , the first coupling member 637a defines a flow path 638a that is fluidly coupled to the piercing member 655a. As described above, the coupling member 637a can be physically and fluidly coupled to the distribution member 629. For example, the flow path 638a can receive a portion of the second outlet port 631 of the distribution member to physically and fluidly couple the coupling member 637a thereto. In some embodiments, the surface of the second outlet port 631 can form a substantially fluid-tight seal (e.g., a friction fit that can form a substantially airtight seal) with the inner surface of the coupling portion 637a that defines the flow path 638a. The piercing member 655a of the coupling portion 637a can be substantially similar in form and function to the piercing member 455a included in the collection device 400 of FIGS. 16-22. Accordingly, the piercing member 655a will not be described further herein. The second coupling member 637b, the third coupling member 637c, and the fourth coupling member 637d are similarly arranged. Accordingly, second coupling member 637b, third coupling member 637c, and fourth coupling member 637d each include piercing members 655b, 655c, and 655d, respectively, and define flow paths 638b, 638c, and 638d, respectively. As described in further detail herein, first coupling member 637a, second coupling member 637b, third coupling member 637c, and fourth coupling member 637d can be used to selectively position flow dividing structure 620 in fluid communication with first sample reservoir 680, second sample reservoir 680′, third sample reservoir 690, and fourth sample reservoir 690′, respectively.

[0087]

[1140] As shown in FIGS. 30 and 31 , the flow controller 640 includes a dial 645 and a seal member 641. The dial 645 of the flow controller 640 is rotatably disposed within the distribution member 629 (see FIGS. 32 and 33 ) and is movable between a first position, a second position, a third position, and a fourth position. The dial 645 includes an inlet port 621, a first outlet port 647, and a second outlet port 648, each of which is fluidly connected to an interior space 646 (see, e.g., FIG. 30 ). The interior space 646 is configured to receive a portion of the seal member 641, as described in further detail herein. The inlet port 621 can be fluidly coupled to a medical device (not shown) that defines a fluid flow path for withdrawing and / or transporting bodily fluid from a patient to the collection device 600. For example, the inlet port 621 can be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) directly or indirectly via an adapter 604 (see, e.g., FIGS. 26 and 27 ). First outlet port 647 is in fluid communication with pre-sample reservoir 670. For example, first outlet port 647 can be rotatably disposed within first outlet port 630 of distribution member 629. Second outlet port 648 can be selectively disposed to be in fluid communication with second outlet port 631, third outlet port 632, fourth outlet port 633, and fifth outlet port 634 when dial 645 is in its first, second, third, and fourth positions, respectively. In this manner, interior space 646 of dial 645 can be selectively disposed to be in fluid communication with pre-sample reservoir 670, first sample reservoir 680, second sample reservoir 680′, third sample reservoir 690, and fourth sample reservoir 690′, as described in further detail herein.

[0088]

[1141] At least a portion of a seal member 641 of the flow controller 640 is rotatably disposed within an interior space 646 of a dial 645 and is movable between a first position and a second position. Furthermore, the seal member 641 can be sized and shaped such that an outer surface of the seal member 641 forms a substantially fluid-tight seal with an inner surface of the dial 645, which defines at least a portion of the interior space 646. As shown in FIG. 31 , the seal member 641 defines a first flow path 642 and a second flow path 644. When the seal member 641 is in its first position within the interior space 646, the flow path 642 establishes fluid communication between the inlet port 621 and a first outlet port 647 while fluidly isolating the inlet port 621 from a second outlet port 648. Similarly, when the seal member 641 is in its second position within the interior space 646, the second flow path 644 establishes fluid communication between the inlet port 621 and the second outlet port 648 while fluidly isolating the inlet port 621 from the first outlet port 647. The collection device 600 operates similarly when the dial 645 is rotated within the distribution member 629 to the second, third, and fourth positions. Thus, when the inlet port 621 is positioned to be fluidly connected to a patient (e.g., via a medical device coupled to the inlet port 621 and / or the adapter 604), the first outlet port 630, the second outlet port 631, the third outlet port 632, the fourth outlet port 633 and the fifth outlet port 634 of the distribution member 629 can be selectively positioned to be fluidly connected to the inlet port 621 to allow bodily fluid to flow into the pre-sample reservoir 670, the first sample reservoir 680, the second sample reservoir 680', the third sample reservoir 690 and the fourth sample reservoir 690', respectively.

[0089]

[1142] In operation, the collection device 600 can be used to collect bodily fluids (e.g., blood, plasma, urine, etc.) from a patient with reduced contamination. For example, the inlet port 621 of the collection device 600 can be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). Following venipuncture (or other method of accessing bodily fluids), the seal member can be actuated (or rotated) to its first position, as shown in FIG. 32 . Alternatively, the seal member 641 can be preset to the first position, and the collection device 600 can be sealed in other manners to maintain the sterility of the collection device 600. When the seal member 641 is in its first position, the flow controller 640 establishes fluid communication between the inlet port 621 and the first outlet port 630 of the distribution member 629, while fluidly isolating the inlet port 621 from the coupling members 637a, 637b, 637c, and 637d. Thus, as shown by arrow II in FIG. 32, bodily fluid can be transferred from the patient through the inlet port 621, the first flow path 642, the first outlet port 647 of the dial 645, the first outlet port 630 of the distribution member 629, and into the pre-sample reservoir 670 in a manner similar to that described above with respect to the collection device 400.

[0090]

[1143] Following collection of the bodily fluid pre-sample in pre-sample reservoir 670, seal member 641 can be actuated (rotated) from its first position to its second position relative to dial 645. Similarly, as shown in FIG. 33 , dial 645 can be actuated (or rotated) relative to dispensing member 629 until it reaches its second position. When seal member 641 and dial 645 are in their second positions, flow controller 640 is disposed in its second configuration, and second flow path 644 of seal member 641 fluidly isolates pre-sample reservoir 670 from inlet port 621 while establishing fluid communication between inlet port 621 and flow path 638a of first coupling member 637a. With flow controller 640 in its second configuration, sample reservoir 680 can be actuated from its first configuration to its second configuration by a user (e.g., by pushing piercing member 655a) to establish fluid communication between a portion of the patient's body (e.g., a vein) and first sample reservoir 680. As described in detail above, moving the sample reservoir 680 to the second configuration causes the piercing member 655a to pierce the vacuum seal of the sample reservoir 680 and be positioned inside the sample reservoir 680. In this second configuration, the portion of the patient's body (e.g., a vein) is exposed to a vacuum suction force from the sample reservoir 680 due to the negative pressure condition (vacuum) within the sample reservoir 680. Thus, bodily fluid can be forced to flow from the portion of the patient's body through the inlet port 621, the second flow path 644, the second outlet port 631, the flow path 638a, and the piercing member 655a of the first coupling member 637a into the first sample reservoir 680, as shown by arrows JJ in FIG.

[0091]

[1144] Once a desired volume (e.g., a second amount) of bodily fluid has collected in sample reservoir 680, a user can actuate (rotate) flow controller 640 to a third position and / or move sample reservoir 680 back to its first configuration to isolate first sample reservoir 680 from second flow path 644. When sample reservoir 680 returns to the first configuration, piercing member 655a is removed from sample reservoir 680 and a seal (e.g., a self-sealing membrane) of sample reservoir 680 fluidly isolates first sample reservoir 680 from flow path 635a. Filling of the other sample reservoirs is similarly performed with flow controller 640 disposed in the third, fourth, and fifth configurations, respectively.

[0092]

[1145] 34-40 illustrate a collection device 700 according to an embodiment. The collection device 700 includes a flow diverter mechanism 720, a flow controller 740, and sample reservoirs 780 and 790 (though there are holders for four sample reservoirs, only two sample reservoirs are included in the figures for clarity; additional sample reservoirs (e.g., a fifth, sixth, etc.) can be included as part of the collection device 700). As described further herein, the collection device 700 can be moved between the first, second, third, fourth, and fifth configurations to deliver a flow of bodily fluid that is substantially free of extracorporeal microorganisms, such as microorganisms present on the skin and / or other undesirable external contaminants. The collection device 700 can be of any suitable shape, size, or configuration. For example, aspects and / or portions of the collection device 700 can be substantially similar in form and / or function to corresponding aspects and / or portions of any of the collection devices 100, 200, 300, 400, 500, and / or 600 described above. Accordingly, such similar aspects and / or portions will not be described in further detail herein. By way of example, in some embodiments, sample reservoirs 780 and 790 of collection device 700 may be substantially similar and / or identical in form and function to sample reservoirs 480 and 490, respectively, included in collection device 400 of Figures 16-22.

[0093]

[1146] The flow distribution structure 720 includes a housing 701, a distribution member 729, and a base plate 771. As described above with respect to the collection device 400, the housing 701 defines a first outlet opening 703 a, a second outlet opening 703 b, a third outlet opening 703 c, a fourth outlet opening 703 d, and a fifth outlet opening 703 e, each configured to be in fluid communication with a different portion of the distribution member 729. More specifically, the distribution member 729 defines and / or forms at least a portion of a pre-sample reservoir 770 in fluid communication with the first outlet opening 703 a, a first fluid chamber 735 a in fluid communication with the second outlet opening 703 b, a second fluid chamber 735 b in fluid communication with the third outlet opening 703 b, a third fluid chamber 735 c in fluid communication with the fourth outlet opening 703 d, and a fourth fluid chamber 735 d in fluid communication with the fifth outlet opening 703 e. Additionally, the housing 701 defines a recess 766 configured to movably receive at least a portion of the flow controller 740, as described further herein.

[0094]

[1147] As shown in FIG. 36 , the distribution member 729 defines a chamber or space that forms at least a portion of a pre-sample reservoir 770. The pre-sample reservoir 770 is configured to contain a bodily fluid, such as blood, plasma, or urine. The first outlet opening 703a of the housing 701 can be substantially aligned with the open portion of the pre-sample reservoir 770 so that the pre-sample reservoir 770 can receive a flow of bodily fluid from a patient, as described in detail above. More specifically, the distribution member 729 includes a set of walls 736 that can, for example, divide the interior space of the distribution member 729 into portions and / or spaces that are fluidly isolated from one another. For example, as shown in FIG. 36 , the set of walls 736 can divide the interior space of the distribution member 729 into the pre-sample reservoir 770, a first fluid chamber 735a, a second fluid chamber 735b, a third fluid chamber 735c, and a fourth fluid chamber 735d. In some embodiments, wall 736 can equally define and / or form pre-sample reservoir 770 and fluid chambers 735a-735d. In other embodiments, pre-sample reservoir 770 can define a space that is different from the space defined by fluid chambers 735a-735d.

[0095]

[1148] Distribution member 729 further includes first piercing member 755a, second piercing member 755b, third piercing member 755c, and fourth piercing member 755d in fluid communication with first fluid chamber 735a, second fluid chamber 735b, third fluid chamber 735c, and fourth fluid chamber 735d, respectively. Piercing members 755a-d can thus be used to puncture sample reservoirs 780 and 790 (and corresponding sample reservoirs not shown in Figures 34-40), as described in further detail herein, thereby initiating the flow of bodily fluid.

[0096]

[1149] The flow controller 740 of the collection device 700 includes a dial 745 and a seal member 741. The seal member 741 is disposed within a recess 766 of the housing 701 (see, for example, FIGS. 38 and 40 ). More specifically, the flow controller 740 can be coupled to the housing 701 such that the seal member 741 is disposed between and in contact with a surface of the housing 701 that defines the recess 766 and a surface of the dial 745. The seal member 741 can be configured to form a substantially fluid-tight seal with the surface of the dial 745 and the surface of the housing 701 that defines the recess 766, as described in detail above. As shown in FIG. 35 , the seal member 741 defines a first opening 744 a, a second opening 744 b, a third opening 744 c, a fourth opening 744 d, and a fifth opening 744 e. The arrangement of the sealing member 741 is such that when the sealing member 741 is positioned within the recess 766, the first opening 744a, the second opening 744b, the third opening 744c, the fourth opening 744d and the fifth opening 744e are substantially aligned with the first outlet opening 703a, the second outlet opening 703b, the third outlet opening 703c, the fourth outlet opening 703d and the fifth outlet opening 703e of the housing 701, respectively.

[0097]

[1150] A dial 745 of the flow controller 740 is rotatably coupled to the housing 701 and is movable relative to the housing 701 between a first position, a second position, a third position, a fourth position, and a fifth position. The dial 745 includes an inlet port 721 that can be fluidly coupled (directly or indirectly via an adapter 704) to a medical device that defines a fluid flow path for withdrawing bodily fluid from a patient and / or transporting it to the collection device 700. In this manner, the inlet port 721 can be configured to selectively place the pre-sample reservoir 770, the first sample reservoir 780, the second sample reservoir 780′, the third sample reservoir 790, and the fourth sample reservoir 790′ in fluid communication with the patient, as described in further detail herein. When dial 745 is in a first position, flow controller 740 is placed in a first configuration, allowing inlet port 721 to be substantially aligned with first opening 744a of seal member 741 and first outlet opening 703a of housing 701. In this manner, first opening 744a of seal member 741 fluidly isolates inlet port 721 from outlet openings 703b, 703c, 703d, and 703e, thereby establishing fluid communication between inlet port 721 and first outlet opening 703a while fluidly isolating inlet port 721 from fluid chambers 735a-d. When the dial 745 is turned (or actuated) to the second position, the flow controller 740 is placed in a second configuration and the second outlet opening 744b establishes fluid communication between the inlet port 721 and the second outlet opening 703b while fluidly isolating the inlet port 721 from the pre-sample reservoir 770 and the fluid chambers 735b-735d. The collection device 700 operates similarly when the dial 745 is turned to the third, fourth, and fifth positions.Thus, when the inlet port 721 is positioned in fluid communication with a patient (e.g., via a medical device coupled to the inlet port 721), the first outlet opening 703a, the second outlet opening 703b, the third outlet opening 703c, the fourth outlet opening 703d and the fifth outlet opening 703e can be selectively positioned in fluid communication with the inlet port 721 so that all of the bodily fluid can flow into the pre-sample reservoir 770, the first sample reservoir 780 or the second sample reservoir 790 (or any other fluid reservoir coupled thereto).

[0098]

[1151] In some embodiments, housing 701 can selectively limit movement of dial 745 from its first position to its second, third, fourth, and fifth positions. In some other embodiments, housing 701 can be configured to prevent movement of the dial once it has been moved to the fifth position. In other words, housing 701 can include a locking mechanism that prevents movement of dial 745 from the fifth position back to the first position. This feature can reduce the risk of contamination of bodily fluids collected in flow chambers 735a-735d and / or sample reservoirs 780 and 790 from bodily fluids contained in pre-sample reservoir 770 (which are at higher risk of containing surface-bound microorganisms and / or other undesirable external contaminants). This locking mechanism can also protect healthcare workers from exposure to blood-borne pathogens in patient samples, which may include HIV, Hepatitis C, etc. Dial 745 and / or housing 701 may also include mechanical detents and / or other indicators that provide visual or tactile feedback to ensure correct alignment of dial 745 relative to outlet port 703a and outlet openings 703a-703d in housing 701.

[0099]

[1152] Similar to the embodiment of collection device 400 shown in FIGS. 16-22, collection device 700 includes a pre-sample reservoir 770, which is a chamber contained within distribution member 729. Pre-sample reservoir 770 can contain a bodily fluid, such as blood, plasma, urine, or the like. Pre-sample reservoir 770 is configured to be fluidly coupled to a first outlet port 703a of collection device 700 (located within housing 701). During operation of collection device 700, when flow controller 740 is in the first position, bodily fluid is drawn from a portion of the patient's body (e.g., a vein) through inlet port 721, into pre-sample reservoir 770, an opening for pre-sample reservoir 744a located within seal member 741, and into first outlet port 703a. The pre-sample reservoir 770 is configured to contain a first amount of fluid to be drawn from a patient, where the first amount of bodily fluid can be a predetermined amount or an undetermined amount, such that the first amount of bodily fluid is fluidly isolated from second and / or third and / or fourth and / or fifth amounts of bodily fluid that are subsequently drawn from the patient.

[0100]

[1153] In operation, the collection device 700 can be used to collect bodily fluids (e.g., blood, plasma, urine, etc.) from a patient with reduced contamination. For example, the inlet port 721 of the collection device 700 can be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). Following venipuncture, the dial 745 is turned until it reaches a first position, as shown in FIGS. 37 and 38 . Alternatively, as described above, the dial 745 can be preset at the first position, and the collection device 700 can be otherwise sealed to maintain the sterility of the collection device 700. With the dial 745 in the first position, the flow controller 740 is placed in a first configuration, and the first outlet opening 744a of the seal member 741 establishes fluid communication between the inlet port 721 (contained within the housing 701) and the first outlet port 741 while fluidly isolating the inlet port 721 from the four sample channels 735a-735d. In this first configuration, bodily fluid flows from the portion of the patient's body through the inlet port 721, the first outlet opening 744a of the seal member 741, the first outlet port 703a of the housing 701, and into the pre-sample reservoir 770 defined by the distribution member 770, as shown by the arrows KK in Figure 38. Thus, a first amount of bodily fluid (predetermined or undetermined) can be received in the pre-sample reservoir 770 immediately after venipuncture and isolated from subsequent samples, as described in detail above.

[0101]

[1154] Following collection of the bodily fluid pre-sample in the pre-sample reservoir 770, the dial 745 can be actuated (or rotated) until it reaches a second position, as shown in FIGS. 39 and 40 . When the dial 745 is in the second position, the flow controller 740 is disposed in a second configuration, and the second outlet opening 744a of the seal member 741 fluidly isolates the pre-sample reservoir 770 from the inlet port 721 while establishing fluid communication between the inlet port 721 and the first fluid chamber 735a. Once the first fluid chamber 735a is filled with bodily fluid, the flow controller 740 can be moved to a third position to isolate and seal the first flow path 735a from the external environment. Additionally, the sample reservoir 780 can be actuated from the first configuration to the second configuration to transfer bodily fluid from the first fluid chamber 735a to the sample reservoir 780. For example, the sample reservoir 780 can be actuated (pushed by the piercing member 755a) from the first configuration to the second configuration, either by a user or automatically, to establish fluid communication between a portion of the patient's body (e.g., a vein) and the sample reservoir 780. As described above, by moving the sample reservoir 780 to the second configuration, the piercing member 755a pierces the vacuum seal of the sample reservoir 780 and is positioned inside the sample reservoir 780. In the second configuration, the portion of the patient's body (e.g., a vein) is exposed to vacuum suction from the sample reservoir 780 due to a negative pressure condition (vacuum) that exists within the sample reservoir 780 in some embodiments. Thus, as shown by arrow LL in FIG. 40 , bodily fluid flows from the portion of the patient's body through the inlet port 721, the second outlet opening 744b of the seal member 741, the second outlet opening 703b of the housing 701, the second fluid chamber 735b, and into the first sample reservoir 780.

[0102]

[1155] Once a desired amount (e.g., a second amount) of bodily fluid has collected in sample reservoir 780, a user can actuate (rotate) flow controller 740 to a third position and / or move sample reservoir 780 back to its first configuration to isolate first sample reservoir 780 from inlet port 721. When sample reservoir 780 returns to the first configuration, piercing member 755a is removed from sample reservoir 780 and a seal (e.g., a self-sealing membrane) of sample reservoir 780 fluidly isolates first sample reservoir 780 from second fluid chamber 735b and the external environment. Filling of the other sample reservoirs is performed in the same manner with flow controller 740 in each of the third, fourth, and fifth configurations.

[0103]

[1156] In some embodiments, the collection device 700 can be configured so that there is no set of walls 736 separating the different fluid chambers 735a-735d within the distribution member 729 (see detailed cross-section in FIG. 16). In such embodiments, the distribution member 729 is divided between the pre-sample reservoir 770 and the associated fluid chamber 735 (i.e., the fluid chamber is not separated into four separate portions by walls 736). In such embodiments, a user can fill all four sample reservoirs at once by actuating (rotating) the dial 745 to either the second, third, fourth, or fifth position.

[0104]

[1157] Any of the embodiments described herein can be used with a metering device that can be used, for example, to meter (e.g., quantify) the flow of bodily fluid into the pre-sample reservoir and / or sample reservoir. In some cases, testing standard practices do not ensure consistent compliance with the correct inoculation volume of bodily fluid (e.g., blood sample) due to the fact that the fill volume is visually determined by the clinician and / or phlebotomist and is therefore prone to human error. The volume indicator on the blood collection bottle is difficult to read when held, and the fact that the collection bottle is not held upright during the withdrawal procedure can contribute to inaccurate volumes of bodily fluid samples received from patients. Insufficient sample volume (e.g., less than the manufacturer's recommendation) can reduce the sensitivity of the culture test and lead to false-negative results. Furthermore, as directed in the briefing materials and instructions for use for certain types of testing supplies and equipment (e.g., blood culture bottles designed for use with automated microbial detection systems produced by manufacturers such as Becton Dickinson of Franklin Lakes, NJ), fill volumes greater than the manufacturer's recommendation can result in false positives. Thus, the flow metering and volume display features allow a laboratory technician and / or medical personnel (e.g., a phlebotomist) to ascertain the volume of bodily fluid that will be collected in each individual sample reservoir before placing the sample reservoir in an incubator or other laboratory testing equipment, depending on how the sample needs to be processed. The laboratory technician and / or phlebotomist can also record accurate volume information (e.g., in a medical record, database, spreadsheet, etc.) for evaluation by a clinician when results are received, thereby helping to reduce the likelihood of misinterpretation of false-negative and / or false-positive results.

[0105]

[1158] 41-45 illustrate a collection device 800, which may include one or more metering devices. The collection device 800 includes a flow diverter mechanism 820, a flow controller 840, a display 875, and a sample reservoir 880. As described further herein, the collection device 800 can be moved between a first configuration, a second configuration, and a third configuration to deliver a flow of bodily fluid that is substantially free of extracorporeal microorganisms, such as, for example, microorganisms present on the skin and / or other undesirable external contaminants. The collection device 800 may be of any suitable shape, size, or configuration. For example, aspects and / or portions of the collection device 600 may be substantially similar in form and / or function to corresponding aspects and / or portions of any of the collection devices 100, 200, 300, 400, 500, 600, and / or 700 described above. Accordingly, such similar aspects and / or portions will not be described in further detail herein. By way of example, in some embodiments, the sample reservoir 880 of the collection device 800 may be substantially similar and / or identical in form and function to the sample reservoir 480 included in the collection device 400 of Figures 16-22.

[0106]

[1159] As shown in FIGS. 41-43 , the flow diverter mechanism 820 includes an actuator portion 822 (e.g., a first portion), an intermediate portion 823 (e.g., a second portion), and a coupling portion 824 (e.g., a third portion). The actuator portion 822 of the flow diverter mechanism 820 is substantially cylindrical, including a pair of actuator walls that define an interior space 806. More specifically, the actuator portion 822 includes a first end that is substantially closed and a second end opposite the first end that is substantially open to allow access to the interior space 806. As such, the actuator portion 822 can movably receive at least a portion of a flow controller 840, as described in further detail herein. The actuator portion 822 further includes an inlet port 821 and an outlet port 831. The inlet port 821 can be fluidly coupled (directly or indirectly via an adapter 804) to a medical device that defines a fluid flow pathway for withdrawing and / or transporting bodily fluid from a patient to the collection device 800, as described in detail above.

[0107]

[1160] The outlet port 831 of the actuator portion 822 can be selectively positioned to fluidly connect a portion of the interior space 806 of the actuator portion 822 to the interior space 807 defined by the intermediate portion 823. As shown in FIG. 43 , the intermediate portion 823 is positioned between the actuator portion 822 and the coupling portion 824. Although not shown in FIGS. 41-45 , the intermediate portion 823 can include a metering device that can be configured to, for example, meter the volume of bodily fluid transferred to the sample reservoir 880. For example, in some embodiments, the flow metering device can be fluidly coupled to the outlet port 831 to meter the flow of bodily fluid therethrough. As shown in FIGS. 41 and 42 , the intermediate portion 823 can include a display 875 that can provide a user with a visual indicator and / or information related to, for example, the volume of bodily fluid that has flowed through the outlet port 831. In other embodiments, the flow metering device can be positioned at any other suitable location within or along the flow diverter mechanism 820.

[0108]

[1161] Coupling portion 824 can be physically and fluidly coupled to intermediate portion 823. For example, in some embodiments, coupling portion 824 can be partially disposed within interior space 807 of intermediate portion 823 and at least temporarily coupled thereto via a friction fit, press fit, snap fit, threaded connection, adhesive, or the like. Coupling portion 824 is configured to receive a portion of sample reservoir 880, as described in detail above, and includes piercing member 855 that can be used to pierce a vacuum seal of sample reservoir 880, thereby initiating the flow of bodily fluid.

[0109]

[1162] The flow controller 840 of the collection device 800 is at least partially disposed within the interior space 806 defined by the actuator portion 822 and is movable between a first configuration, a second configuration, and a third configuration. As shown in FIGS. 42 and 43 , the flow controller 840 includes a movable member 850 having a first seal member 861, a second seal member 862, and a third seal member 863, and a biasing member 859 (e.g., a spring, etc.). The seal members 861, 862, and 863 contact an inner surface of the actuator portion 822 that defines the interior space 806. Thus, as described in further detail herein, the seal members 861, 862, and 863 can each form a substantially fluid-tight seal with an inner surface that can divide the interior space 806 of the actuator portion 822 into fluidly isolated portions, for example.

[0110]

[1163] The movable member 850 is movable within the interior space 806 between a first position, a second position, and a third position. The movable member 850 may be arranged such that the seal members 861, 862, and 863 selectively move within the interior space 806 as the movable member 850 moves between its first position, second position, and third position. More specifically, the first seal member 861 may move simultaneously with the movable member 850 as the movable member 850 moves between its first position, second position, and third position. The second seal member 862 and the third seal member 863 may be fixedly coupled to one another (e.g., positioned a fixed distance from one another) and slidably disposed around a portion of the movable member 850, thereby allowing the movable member 850 to move from its first position (e.g., see FIG. 43 ) to its second position (e.g., see FIG. 44 ) while the second seal member 862 and the third seal member 863 remain in a substantially fixed position relative to the actuator portion 822. For example, as movable member 850 moves between its first and second positions, second seal member 862 and third seal member 863 can remain in substantially fixed positions such that inlet port 821 is located on a first side of second seal member 862 and outlet port 831 is located on a second side opposite the first side of second seal member 862. Thus, as described in more detail herein, when movable member 850 is in its first position ( FIG. 43 ) and its second position ( FIG. 44 ), inlet port 821 is in fluid communication with a portion of interior space 806 defined between first seal member 861 and second seal member 862, and outlet port is in fluid communication with a portion of interior space 806 defined between second seal member 862 and third seal member 863.

[0111]

[1164] The flow controller 840 may be configured such that the first seal member 861 moves relative to the second seal member 862 and the third seal member 863 when the movable member 850 moves from its first position to its second position. The movement of the first seal member 861 relative to the second seal member 862 may expand a space defined therebetween, thereby forming and / or otherwise defining a pre-sample reservoir 870. Furthermore, because the seal members 861 and 862 form a substantially fluid-tight seal with the interior surface of the actuator portion 822, the pre-sample reservoir 870 defined between the first seal member 861 and the second seal member 862 is fluidly isolated from the remainder of the interior space 806. Thus, when the movable member 850 moves from its first position to its second position, the inlet port 821 may be in fluid communication with the pre-sample reservoir 870. As movable member 850 moves from its second position (see, e.g., FIG. 44 ) to its third position (see, e.g., FIG. 45 ), a portion of movable member 850 contacts third seal member 863, causing first seal member 861, second seal member 862, and third seal member 863 to move substantially simultaneously within interior space 806. Thus, second seal member 862 can be moved relative to inlet port 821 such that both inlet port 821 and outlet port 831 are in fluid communication with a portion of interior space 806 defined between second seal member 862 and third seal member 863, as described in further detail herein.

[0112]

[1165] In operation, collection device 800 can be used to collect bodily fluids (e.g., blood, plasma, urine, etc.) from a patient with reduced contamination. For example, inlet port 821 of collection device 800 can be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). With inlet port 821 coupled to the lumen-defining device, flow controller 840 can be moved from its first configuration to its second configuration. In this manner, a user can apply a force to move movable member 850 from its first position to its second position, as shown by arrow MM in FIG. 44 . As described above, first seal member 861 moves simultaneously with movable member 850, thereby expanding the space defined between first seal member 861 and second seal member 862, thereby forming and / or defining pre-sample reservoir 870. Because first seal member 861 and second seal member 862 form a substantially fluid-tight seal with the inner surface of actuator portion 822, which defines interior space 806, the increase in volume between first seal member 861 and second seal member 862 creates a negative pressure within pre-sample reservoir 870. Thus, when fluid communication is established between a portion of a patient's body (e.g., a vein) and pre-sample reservoir 870 (e.g., via inlet port 821 in FIG. 44 ), the negative pressure difference between pre-sample reservoir 870 and that portion of the patient's body draws bodily fluid into pre-sample reservoir 870 through inlet port 821, as shown by arrows NN in FIG. 44 . In this first configuration, flow controller 840 also fluidly isolates pre-sample reservoir 870 from outlet port 831. Thus, a first amount (predetermined or undetermined) of bodily fluid can be received into pre-sample reservoir 870 immediately after (e.g.,) venipuncture and isolated from a subsequent sample. In this manner, collection device 800 can be used to prevent a first volume of bodily fluid that is most likely to contain surface microorganisms and / or other undesirable external contaminants from contaminating subsequent volumes of bodily fluid sample that are collected and used for diagnostic or other tests that may be affected by the contaminants.In some embodiments, the metering device can measure the volume of bodily fluid placed in the pre-sample reservoir 870 and present a value related to that volume on the display 875 .

[0113]

[1166] Following collection of the volume of bodily fluid pre-sample in pre-sample reservoir 870, movable member 850 can be moved from its second position to its third position, as indicated by arrow OO in FIG. 45 , to place the flow controller in a third configuration. As described above, as movable member 850 moves from its second position to its third position, a portion of movable member 850 is positioned in contact with third seal member 863. Thus, movable member 850 substantially simultaneously moves first seal member 861, second seal member 862, and third seal member 863 within interior space 806. Thus, second seal member 862 can be moved relative to inlet port 821 such that both inlet port 821 and outlet port 831 are in fluid communication with a portion of interior space 806 defined between second seal member 862 and third seal member 863. Furthermore, because the volume of bodily fluid is fluidly isolated within pre-sample reservoir 870, movement of second seal member 862 and third seal member 863 in the direction of first seal member 861 is restricted (i.e., the bodily fluid is a substantially incompressible fluid). In this manner, the pre-sample volume of bodily fluid is sequestered within pre-sample reservoir 870, and the space defined between second seal member 862 and third seal member 863 defines a fluid flow path between inlet port 821 and outlet port 831. Furthermore, flow controller 840 is arranged such that, when in its third configuration, first seal member 861 is positioned to contact biasing member 859, and at least a portion of the force applied by a user to movable member 850 is operable to deform, compress, bend, and / or otherwise reconfigure biasing member 859. Thus, the biasing member 859 can exert a counter force on the first seal member 861 that resists movement of the flow controller 840 from its second configuration to its third configuration, as described in more detail herein.

[0114]

[1167] As described in detail above, the sample reservoir 880 can be positioned relative to the collection device 800 such that the piercing member 855 pierces a vacuum seal of the sample reservoir 880 and is positioned inside the sample reservoir. A pressure differential between the sample reservoir 880 (e.g., a vacuum or negative pressure) and that part of the body draws bodily fluid into the sample reservoir 880. In other words, in the second configuration, the flow controller 840 and the flow diverter mechanism 820 establish a fluid flow path such that bodily fluid can be drawn from the patient through the inlet port 821, the portion of the interior space 806 defined between the second seal member 862 and the third seal member 863, the outlet port 831 of the actuator portion 822, through the piercing member 855 of the intermediate portion 823 and the coupling portion 824, and into the sample reservoir 880, as shown by arrows PP in FIG. As mentioned above, a metering device (not shown) can, for example, meter the volume of bodily fluid transferred through outlet port 831 and present a value related to the volume of bodily fluid on display 875.

[0115]

[1168] Once a desired volume (e.g., a second amount) of bodily fluid has collected in sample reservoir 880, the user can remove and / or reduce the force applied to movable member 850, causing biasing member 859 to move first seal member 861 and movable member 850 from their third position toward their second position. Furthermore, due to the substantially incompressible nature of the bodily fluid disposed in pre-sample reservoir 870, movement of first seal member 861 transfers a force through the volume of bodily fluid, moving second seal member 862 and third seal member 863 from their third position toward their second position. In some embodiments, biasing member 859 can apply a force to first seal member 861 that can be operable to move second seal member 862 relative to actuator portion 822 to a fourth position, e.g., that can substantially block inlet port 821. Thus, inlet port 821 can be fluidly isolated from interior space 806 of actuator portion 822. Additionally, the piercing member 855 can be removed from the sample reservoir 880, and a seal (e.g., a self-sealing membrane) can fluidly isolate the bodily fluid sample from the space outside the sample reservoir 880. Subsequent filling of the sample reservoir can be similarly accomplished by placing the piercing member 855 within the sample reservoir and moving the flow controller 840 to the third configuration to allow bodily fluid to flow from the patient into the sample reservoir.

[0116]

[1169] 46-53 illustrate a collection device 900 according to an embodiment. The collection device 900 includes a flow diverter mechanism 920, a flow controller 940, and sample reservoirs 980, 980′, 990, and 990′. As described further herein, the collection device 900 can be moved between a first configuration, a second configuration, a third configuration, a fourth configuration, and a fifth configuration to deliver a flow of bodily fluid that is substantially free of extracorporeal microorganisms, such as microorganisms present on the skin and / or other undesirable external contaminants. The collection device 900 can be of any suitable shape, size, or configuration. For example, aspects and / or portions of the collection device 900 can be substantially similar in form and / or function to corresponding aspects and / or portions of any of the collection devices 100, 200, 300, 400, 500, 600, 700, and / or 800 described above. Accordingly, such similar aspects and / or portions will not be described in further detail herein. For example, in some embodiments, sample reservoirs 980, 980', 990 and 990' of collection device 900 may be substantially similar and / or identical in form and function to sample reservoirs 680, 680', 690 and 690' included in collection device 600 of Figures 26-33.

[0117]

[1170] Flow diverter mechanism 920 includes a housing 901, a distribution member 929, and movable members 950a, 950b, 950c, and 950d. Housing 901 is physically and fluidly coupled to distribution member 929 and provides and / or defines a set of fluid flow paths for collecting bodily fluid from a patient. Housing 901 includes a set of displays 975′ (e.g., liquid crystal displays (LCDs), etc.) that may be included in and / or otherwise coupled (e.g., electrically and / or mechanically) to a flow metering device, as described in further detail herein. Housing 901 defines a recess 966, outlet openings 903a, 903b, 903c, 903d, and 903e, and movable member openings 950a, 950b, 950c, and 950d (also referred to herein as “openings”). Recess 966 is configured to receive a seal member 941 included in a flow controller 940, as described in further detail herein. The first outlet opening 903a, the second outlet opening 903b, the third outlet opening 903c, the fourth outlet opening 903d, and the fifth outlet opening 903e are each configured to define a different fluid flow path in fluid communication with a different portion of the distribution member 929. More specifically, the distribution member 929 defines and / or forms at least a portion of the pre-sample reservoir 970 in fluid communication with the first outlet opening 903a, a first flow path 935a in fluid communication with the second outlet opening 903b, a second flow path 935b in fluid communication with the third outlet opening 903b, a third flow path 935c in fluid communication with the fourth outlet opening 903d, and a fourth flow path 935b in fluid communication with the fifth outlet opening 903e.

[0118]

[1171] 47 and 48, distribution member 929 defines a chamber or space that defines at least a portion of pre-sample reservoir 970. Pre-sample reservoir 970 is configured to contain a bodily fluid, such as blood, plasma, urine, or the like. As described in detail above with respect to pre-sample reservoir 470 in FIGS. 16-22, first outlet opening 903a of housing 901 can be substantially aligned with an open portion of pre-sample reservoir 970 to allow pre-sample reservoir 970 to receive a flow of bodily fluid from a patient. Flow paths 935a-935d extend radially from a center of distribution member 929 and are positioned such that each flow path 935a, 935b, 935c, and 935d is fluidly isolated from pre-sample reservoir 970 and the other flow paths. In this manner, the flow channels 935a, 935b, 935c, and 935d can direct and / or otherwise define a fluid flow path between a first end defining an opening substantially aligned with the outlet openings 903b, 903c, 930d, and 903e, respectively, and a second end defining an opening or port configured to receive the movable members 950a, 950b, 950c, and 950d, respectively. Although the distribution member 929 is shown in Figures 47 and 48 as including flow channels 935a-935d that are substantially closed, in other embodiments, the flow channels 935a-935d can be substantially open, as shown and described above with respect to the distribution member 429 of Figures 17 and 18. Thus, the distribution member 929 of the collection device 900 can function substantially similarly to the distribution member 429 of the collection device 400.

[0119]

[1172] Movable members 950a, 950b, 950c, and 950d are movably disposed between openings 905a, 905b, 905c, and 905d, respectively, of housing 901 and corresponding openings defined by the second end of distribution member 929. Although not shown in FIGS. 46-53, in some embodiments, movable members 950a, 950b, 950c, and 950d can be operably coupled to a biasing member or the like, as described in detail above with respect to movable members 250 and 250′ of collection device 200. In this manner, movable members 950a, 950b, 950c, and 950d can be actuated (moved) by a user from first and second positions relative to housing 901 and distribution member 929 to direct fluid flow into first sample reservoir 980, second fluid reservoir 980′, third fluid reservoir 990, and fourth sample reservoir 990′, respectively. Movable members 950a, 950b, 950c, and 950d are substantially identical and therefore will be described in FIG. 49 with reference to a single movable member 950. Additionally, some portions of movable member 950 may be substantially similar to movable members 250 and 350 described above. Accordingly, some portions of movable member 950 will not be described in further detail herein. Movable member 950 defines an internal cavity 952 that is in fluid communication with an inlet port 953 and a piercing member 955. The piercing member is substantially similar to that described in detail above. Inlet port 953 extends through a set of walls that define internal chamber 952 to selectively position interior space 952 of movable member 950 in fluid communication with a corresponding flow channel 935a, 935b, 935c, or 935d.

[0120]

[1173] As shown in FIG. 49 , the movable member 950 includes a flow control mechanism 967 rotatably disposed within the interior space 952 and in substantially direct fluid communication with the inlet port 953. The flow metering mechanism 967 may be, for example, a wheel that may include a set of spokes or fins. In this manner, bodily fluid may enter the inlet port 953 of the movable member 950 and flow through the flow metering device 967, which may rotate relative to the movable member 950. Thus, the rotational characteristics of the flow metering device 967 may be usable in determining the volume, volumetric flow rate, etc., of bodily fluid transferred to the interior space 952 of the movable member 950. Although not shown in FIGS. 46-53 , the flow control mechanism 967 of the movable member 950 is operably coupled to a display 975′ of the housing 901. Thus, as the bodily fluid is transferred, for example, to sample reservoirs 980, 980′, 990 and / or 990′, volumetric information related to the flow of bodily fluid can be presented on display 975′. In this manner, a user can operate collection device 900 to collect a bodily fluid sample from a patient and visualize at least one of displays 975′ to determine, for example, the exact volume of the bodily fluid sample that will be transferred to sample reservoir 980.

[0121]

[1174] The flow controller 940 of the collection device 900 includes a dial 945 and a seal member 941. The seal member 941 is disposed within a recess 966 of the housing 901. More specifically, the flow controller 940 can be coupled to the housing 901 such that the seal member 941 is disposed between and in contact with a surface of the housing 901 that defines the recess 966 and a surface of the dial 945. As described in detail herein, the seal member 941 can be configured to form a substantially fluid-tight seal with the surface of the dial 945 and the surface of the housing 901 that defines the recess 966. As shown in FIG. 47 , the seal member 941 defines a first opening 944 a, a second opening 944 b, a third opening 944 c, a fourth opening 944 d, and a fifth opening 944 e. The sealing member 941 is positioned such that when the sealing member 941 is positioned within the recess 966, the first opening 944a, the second opening 944b, the third opening 944c, the fourth opening 944d and the fifth opening 944e are substantially aligned with the first outlet opening 903a, the second outlet opening 903b, the third outlet opening 903c, the fourth outlet opening 903d and the fifth outlet opening 903e of the housing 901, respectively.

[0122]

[1175] A dial 945 of the flow controller 940 is rotatably coupled to the housing 901 and is movable relative to the housing 901 between a first position, a second position, a third position, a fourth position, and a fifth position. The dial 945 includes an inlet port 921 that can be fluidly coupled (directly or indirectly via an adapter 904) to a medical device that defines a fluid flow path for withdrawing bodily fluid from a patient and / or transporting it to the collection device 900. In this manner, the inlet port 921 can be configured to selectively place the pre-sample reservoir 970, the first sample reservoir 980, the second sample reservoir 980′, the third sample reservoir 990, and the fourth sample reservoir 990′ in fluid communication with the patient, as described in further detail herein. The dial 945 can be configured to rotate through a first position, a second position, a third position, a fourth position, and a fifth position in a manner substantially similar to that described above with respect to the dial 445 of the collection device 400, and therefore will not be described in further detail herein.

[0123]

[1176] As shown, dial 945 can further include a display 975 that can be configured to present volumetric information related to the flow of bodily fluid. For example, although not shown in FIGS. 46-53 , the dial can include a flow metering device, such as flow metering device 967 included on movable member 950. In this manner, the flow metering device can meter the flow of bodily fluid, for example, through inlet port 921, and can be operably coupled to display 975 such that volumetric information related to the flow of bodily fluid through inlet port 921 is presented on display 975 of dial 945.

[0124]

[1177] In operation, the collection device 900 can be used to collect bodily fluids (e.g., blood, plasma, urine, etc.) from a patient with reduced contamination. For example, the inlet port 921 of the collection device 900 can be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). Following venipuncture (or other method of accessing bodily fluids), the dial 945 is actuated (or turned) until it reaches a first position, as shown in FIGS. 50 and 51 . Alternatively, the dial 945 can be preset to the first position, and the collection device 900 can be sealed in other ways to maintain the sterility of the collection device 900.

[0125]

[1178] As described above, when dial 945 is in the first position, flow controller 940 is placed in a first configuration, and first opening 944a of seal member 941 establishes fluid communication between inlet port 921 and first outlet port 930 (contained within housing 901) while fluidly isolating inlet port 921 from the four flow paths 935a-d. Additionally, sample reservoirs 980, 980', 990, and 990' are fluidly isolated from inlet port 921 in the first configuration, defining a fluid flow path between a portion of the patient's body (e.g., a vein) and pre-sample reservoir 970, as indicated by arrows QQ in FIG. 51 . In this first configuration, bodily fluid flows (e.g., by gravity, vacuum, etc.) from that portion of the patient's body through inlet port 921, first opening 944a of seal member 941, first outlet port 903a of housing 901, and into pre-sample reservoir 970. In the first configuration, the flow controller 940 also fluidly isolates the pre-sample reservoir 970 from the flow paths 935a-935d. Thus, a first volume (predetermined or undetermined) of bodily fluid can be received into the pre-sample reservoir 970 immediately after venipuncture and isolated from subsequent samples. In this manner, the collection device 900 can be used to prevent a first volume of bodily fluid, which is most likely to contain surface microorganisms and / or other undesirable contaminants, from contaminating subsequent volumes of bodily fluid samples collected and used for diagnostic or other tests that may be affected by the contaminants. Furthermore, the display 975 can present information received from a flow control mechanism (not shown), for example, related to the volume of bodily fluid transferred to the pre-sample reservoir 970. Thus, a precise volume of bodily fluid can be transferred to and fluidly isolated within the pre-sample reservoir.

[0126]

[1179] Following collection of the bodily fluid pre-sample in the pre-sample reservoir 970, the dial 945 can be actuated (or rotated) until it reaches a second position, as shown in Figures 52 and 53. When the dial 945 is in the second position, the flow controller 940 is placed in a second configuration, and the second opening 944b of the seal member 941 establishes fluid communication between the inlet port 921 and the flow path 935a while fluidly isolating the pre-sample reservoir 970 from the inlet port 921. With the flow controller 940 in the second configuration, the movable member 950a can be actuated (i.e., depressed) by a user from the first position to the second position to establish fluid communication between the patient (e.g., a vein) and the first sample reservoir 880. More specifically, as shown by arrow RR in FIG. 53, the movable member 950 moves from its first position to its second position so that the piercing member 955 passes through the vacuum seal of the first sample reservoir 980 and is positioned within the first sample reservoir 980.

[0127]

[1180] While in the second position, the inlet port 953 of the movable member 950 is substantially aligned with and in fluid communication with the first flow path 935a, thereby allowing bodily fluid to flow from the first flow path 935a into the interior cavity 952 of the movable member 950, out the piercing member 955, and into the first sample reservoir 980. A pressure differential between the sample reservoir 980 (e.g., vacuum or negative pressure) and the first flow path 935a draws bodily fluid into the sample reservoir 980. In other words, in the second configuration, the flow controller 940 and the movable member 950a establish a fluid flow path between the inlet port 921 of the dial 945 and the first sample reservoir 980, as shown by arrow SS in FIG. 53 . Additionally, the flow of bodily fluid through the movable member 950a causes the flow metering mechanism 967 to rotate relative to the movable member 950. Thus, rotation of the flow metering mechanism 967 may be used to determine the volume of the bodily fluid sample transferred to the sample reservoir 980. Additionally, the display 975' may present information received from the flow control mechanism 967, for example, related to the volume of bodily fluid transferred to the sample reservoir 980. Thus, an accurate volume of bodily fluid may be transferred to the sample reservoir 980. For example, in some cases, the collection device 900 may be used to collect three sample volumes of 20 mL each into the first sample reservoir 980, the second sample reservoir 980', and the third sample reservoir 990 (i.e., a total sample volume of 60 mL is collected).

[0128]

[1181] Once a desired volume (e.g., a second amount) of bodily fluid has been collected in the first sample reservoir 980, the user can release the movable member 950, allowing the biasing member (not shown) to move back to its first position. When the movable member 950 returns to its first position, the piercing member 955 is removed from the first sample reservoir 980, and a seal (e.g., a self-sealing membrane) fluidly isolates the first sample reservoir 980 from the internal flow path 935. The collection device 900 can be used to similarly transfer a second sample volume to the second sample reservoir 980′, a third sample volume to the third sample reservoir 990, and a fourth sample volume to the fourth sample reservoir 990′ by rotating the dial 945 to its third, fourth, and fifth positions, respectively.

[0129]

[1182] In some cases, the fluid collection device 900 allows a clinician and / or phlebotomist to open a package containing the fluid collection device 900, remove only the housing 901 (including the dispensing member 929), and take the housing 901 to the patient's bedside. The clinician and / or phlebotomist can perform venipuncture on a part of the patient's body (e.g., a vein) using any standardized technique (or employ any other method of accessing the patient's bodily fluids). Following venipuncture, the clinician and / or phlebotomist can collect the total blood volume required for all samples. For example, the clinician and / or phlebotomist can collect a 2.5 mL pre-sample diversion volume and a 10 mL sample volume for each of the four sample reservoirs, resulting in a total of 42.5 mL of collected bodily fluid (e.g., blood). Following collection of the desired amount of bodily fluid, the hypodermic needle can be removed from that portion of the patient's body (e.g., a vein), and the clinician and / or phlebotomist can place the housing 901 (containing the bodily fluid) onto a four-pack (or two-pack) of pre-sterilized sample reservoirs, with the membrane tops pre-placed in a custom tray that matches the shape of the housing 901. By using such a pre-sterilized pack of sample reservoirs, the clinician does not need to perform a process step of "wiping" the tops of the sample reservoirs with a sterilant, thereby reducing the possibility of contamination, for example, if the reservoir tops are improperly and / or insufficiently sterilized. The clinician and / or phlebotomist can then initiate automated inoculation of the sample reservoirs with bodily fluid with precise volume control. In some embodiments, after inoculation of the sample reservoirs is complete, the entire device 900, with volume information displayed for each individual sample reservoir, can be sent to a laboratory for analysis. In other embodiments, sample reservoirs 980 and / or 990 can be individually removed and sent to a laboratory for analysis.

[0130]

[1183] Although the collection device 900 has been shown and described with reference to FIGS. 46-53 as including a pair of displays 975 and 975′ capable of presenting volumetric data regarding the volume of bodily fluid transferred through a portion of the collection device, in other embodiments, the collection device may include any suitable flow metering mechanism having any suitable output indicator. For example, FIGS. 54 and 55 illustrate a flow diverter mechanism 1020 and a flow controller 1040 according to an embodiment. The flow diverter mechanism 1020 and the flow controller 1040 may be substantially similar in form and function to the flow diverter mechanism 920 and the flow controller 940, respectively. Accordingly, similar portions will not be further described herein. However, the flow diverter mechanism 1020 and the flow controller 1040 may differ in the placement of the pair of displays 1075. For example, flow diverter mechanism 1020 includes a housing 1001 configured to movably receive a set of movable members 1050a, 1050b, 1050c, and 1050d, each of which may include a flow metering mechanism, as described above with respect to movable member 950. Thus, movable members 1050a, 1050b, 1050c, and 1050d may be used to determine the exact volume of bodily fluid transferred therethrough. As shown in FIG. 55, display 1075 of housing 1001 may include a set of three lights, including a first light associated with a small volume (e.g., 5 mL), a second light associated with a medium volume (e.g., 20 mL), and a third light associated with an acceptable and / or large volume (e.g., 40 mL). In this manner, as the flow of bodily fluid is transferred through the flow controller 1040 and the flow diverting mechanism 1020, for example, into the first movable member 1050a, the flow metering mechanism contained therein can send a signal or the like to a display, which is operable to illuminate the first light, the second light and / or the third light according to the volume of bodily fluid transferred through the movable member 1050.

[0131]

[1184] In other embodiments, movable members 1050a, 1050b, 1050c, and 1050d can be moved from a first position to a second position, a third position, or a fourth position relative to housing 1001. In such embodiments, the positions can be associated with, for example, an intended volume of bodily fluid to be transferred to a sample reservoir. For example, in some embodiments, a user can actuate (e.g., move) movable member 1050a from its first position to its second position. In such embodiments, the second position can be associated with, for example, a small volume (e.g., 10 mL) of bodily fluid to be transferred to a sample reservoir. In some embodiments, housing 1001 and / or movable member 1050a can include a detent, lock, catch, protrusion, recess, etc. that can temporarily hold movable member 1050a in the second position until a low volume of sample has been transferred to the sample reservoir. Additionally, when placed in the second position, the display 1075 can be configured to illuminate a first light associated with the small volume to indicate to the user the preset volume of bodily fluid to be transferred to the sample reservoir. Once the desired volume of bodily fluid has been transferred to and fluidly isolated within the sample reservoir, the flow diverter mechanism 1020 can be configured to automatically return the movable member 1050a to its first position. In this manner, the flow diverter mechanism 1020 and flow controller 1040 can be physically and fluidly coupled to any number of sample reservoirs and used to transfer precise volumes of bodily fluid to each sample reservoir.

[0132]

[1185] FIG. 56 is a flow chart illustrating a method 1190 for obtaining a predetermined sample volume of bodily fluid from a patient using a flow metering transfer device. The flow metering transfer device can be any of the transfer devices described herein (also referred to herein as a “collection device”). By way of example, in some embodiments, the transfer device can be the collection device 900 described above with reference to FIGS. 46-53. Accordingly, the transfer device can include an inlet port configured to be selectively positioned in fluid communication with a patient, a pre-sample reservoir and a sample reservoir, and a flow metering mechanism configured to meter the flow of bodily fluid from the patient to the pre-sample reservoir and the flow of bodily fluid to the sample reservoir. The method 1190 includes, at 1191, establishing fluid communication between the patient and a port of the flow metering transfer device. For example, the port can be fluidly coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing), and the needle or other lumen-defining device can be inserted into the patient's body (e.g., via a venipuncture event or other method of accessing bodily fluid).

[0133]

[1186] With the port in fluid communication with the patient, fluid communication between the port and the pre-sample reservoir is established at 1192. In some embodiments, the flow metering transfer device can include a flow controller or the like (e.g., flow controller 940 included in collection device 900), which can be actuated and / or manipulated (e.g., rotated) to a position (e.g., a first position) that establishes fluid communication between the port and the pre-sample reservoir. In some embodiments, actuation of the flow controller can cause the flow controller and the flow diverter mechanism to collectively define at least a portion of a fluid flow path between the port and the pre-sample reservoir. In some embodiments, the pre-sample reservoir can include a negative pressure or the like that can initiate the flow of bodily fluid from the patient to the pre-sample reservoir. In other embodiments, the flow of bodily fluid can be initiated by any other suitable method (e.g., gravity, etc.).

[0134]

[1187] At 1193, the flow of bodily fluid transferred from the patient to the pre-sample reservoir is metered. For example, in some embodiments, the port can include a flow control mechanism capable of metering the flow of bodily fluid through the port (e.g., in a manner similar to that described above with respect to flow control mechanism 967 of collection device 900). Thus, a pre-sample volume of bodily fluid is transferred to the pre-sample reservoir. At 1194, method 1190 includes verifying, via the flow metering mechanism of the flow metering transfer device, that the pre-sample volume of bodily fluid placed in the pre-sample reservoir is a predetermined pre-sample volume of bodily fluid. For example, the flow metering mechanism can include and / or be operably coupled to a display or the like (e.g., display 975 and / or 975′ of collection device 900). The flow metering mechanism can be configured to present volume information on a display, as described above.

[0135]

[1188] Once the pre-sample volume of bodily fluid is placed in the pre-sample reservoir, the pre-sample reservoir is fluidly isolated from the port at 1195 to seal the pre-sample volume of bodily fluid within the pre-sample reservoir. For example, in some cases, the flow controller and / or flow diverter mechanism can be actuated (or rotated) from a first position and / or configuration to a second position and / or configuration. When the flow controller and / or flow diverter mechanism is in the second configuration, the pre-sample reservoir is fluidly isolated from a space external to the pre-sample reservoir. In some embodiments, when the flow controller and / or flow diverter mechanism is actuated to its second position and / or configuration, fluid communication is established between the port and the sample reservoir at 1196. For example, in some embodiments, the flow metering transfer device can include a movable member (e.g., movable member 950) or the like, which can include a piercing member configured to pierce a portion of the sample reservoir (e.g., a membrane, etc.). Thus, when the flow controller and / or flow diverter mechanism is in its second position and / or second configuration, the perforation of the portion of the sample reservoir places the sample reservoir in fluid communication with the port. As discussed above, the sample reservoir can include, for example, a negative pressure or the like that can initiate the flow of bodily fluid from the patient into the sample reservoir.

[0136]

[1189] At 1197, the flow of bodily fluid transferred from the patient to the pre-sample reservoir is metered. For example, as described above, the port can include a flow control mechanism that can meter the flow of bodily fluid through the port (e.g., in a manner similar to that described above with respect to flow control mechanism 967 of collection device 900). In some embodiments, the flow control mechanism can be included in a movable member, such as movable member 950 of FIG. 49 . Thus, a sample volume of bodily fluid is transferred to the sample reservoir. At 1198, method 1190 includes verifying, via the flow metering mechanism of the flow metering transfer device, that the sample volume of bodily fluid placed in the sample reservoir is the predetermined sample volume. For example, as described above, a display or the like can be configured to present the volume information.

[0137]

[1190] In this manner, a predetermined pre-sample volume of bodily fluid, which may contain, for example, exogenous microorganisms, is collected. For example, in some embodiments, the predetermined pre-sample volume may be about 0.1 mL, about 0.3 mL, about 0.5 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL, about 4.0 mL, about 5.0 mL, about 10 mL, about 20 mL, about 50 mL, and / or any volume or fractional volume therebetween. In other embodiments, the pre-sample volume may be greater than 50 mL or may be 0.1 mL. In other embodiments, the predetermined pre-sample volume may be between about 2 mL and about 5 mL. In one embodiment, the predetermined pre-sample volume may be about 3 mL. Furthermore, collecting the predetermined pre-sample volume can ensure that the predetermined sample volume disposed in one or more sample reservoirs is substantially free of exogenous microorganisms. In some embodiments, the predetermined sample volume may be between 10 mL and 60 mL. In other embodiments, the predetermined sample volume may be between 30 mL and 60 mL. In yet other embodiments, the predetermined sample volume may be 60 mL. Although the sample volume of bodily fluid has been described above as being transferred to a single sample reservoir, in other embodiments, a flow metering transfer device can be used to transfer a predetermined sample volume to two or more sample reservoirs. For example, in some embodiments, a predetermined pre-sample volume of bodily fluid can be collected in and fluidly isolated within a pre-sample reservoir, as described above. With the pre-sample volume fluidly isolated, a flow metering transfer device can be used to transfer the predetermined sample volume to a first sample reservoir, a predetermined sample volume to a second sample reservoir, and a predetermined sample volume to a third sample reservoir. In such a case, the predetermined sample volume can be, for example, 20 mL, resulting in a total sample volume of 60 mL disposed in the first, second, and third reservoirs.

[0138]

[1191] Various embodiments of the bodily fluid collection devices described herein can enable the collection of two (or more) sets of bodily fluid (e.g., blood) samples from a single venipuncture. The current standard of care requires that some tests (e.g., blood cultures) be performed by obtaining samples from separate, independent bodily fluid access points (e.g., via two separate venipunctures, via a catheter plus venipuncture, and / or a combination thereof). The embodiments described herein can facilitate the acquisition of multiple samples for a given diagnostic test (e.g., blood cultures) from a single bodily fluid access point (e.g., venipuncture), thereby reducing the annual number of venipunctures required to obtain these samples by half, benefiting both patients and healthcare professionals alike. Reducing the number of venipunctures (and / or other blood access procedures) can significantly reduce the risk of needlestick injury to healthcare professionals and reduce patient-related complications resulting from these procedures (e.g., hematoma, thrombosis, phlebitis, infection, etc.). Additionally, reducing the number of fluid access procedures (e.g., venipuncture) reduces supply utilization, labor, and waste associated with these procedures. The cost savings realized by the healthcare system are significant and represent an opportunity to promote improved patient outcomes due to more efficient resource consumption, as well as improved sample integrity resulting in more accurate patient diagnoses that inform the development and implementation of treatment plans. Fluid collection devices also significantly reduce the incidence of false positives from post-collection analysis. The fluid collection devices described herein can also streamline the fluid collection process, reducing the number of manual steps and "touch points," thereby reducing the opportunity for external contamination. The devices described herein can also minimize the risk of needlestick injury and infection to laboratory technicians and / or phlebotomists.

[0139]

[1192] In some embodiments, the bodily fluid collection devices described herein (e.g., 100, 200, 300, 400, 500, 600, 700, 800, and 900) can include and / or be partially formed from an antiseptic saturated material (e.g., housing 401). Current standards rely on healthcare professionals placing individual antiseptic materials (e.g., isopropyl alcohol swabs) on top of individual sample reservoirs (e.g., 480, 480′, 490, and 490′). To ensure compliance with this protocol, device 400 (for example) can include antiseptic material disposed within device 400, such that when housing 401 is placed on top of a four-pack (or two-pack) of bottles, the first point of contact from the top of housing 401 and sample reservoirs 480, 480′, 490, and 490′ is the antiseptic material, as shown in FIG. 16 . In this way, it is ensured that the tops of the sample reservoirs 480, 480', 490, 490' are properly disinfected before bodily fluid is inoculated into the sample reservoirs.

[0140]

[1193] While various embodiments have been specifically shown and described, various changes in form and detail may be made. For example, while the dial 445 (actuator) has been shown and described with reference to FIGS. 19-22 as rotating in a single direction, in other embodiments, the dial 445 (actuator) can be rotated in a first direction and a second direction opposite the first direction. In such embodiments, rotation in the second direction can be configured to move the collection device through any number of configurations. In other embodiments, rotation of the actuator in the second direction can be limited. In some embodiments, the dial can include a mechanical stop or lock to fluidically isolate a first volume of bodily fluid received from a patient (i.e., a contaminated sample). In other words, once the first reservoir (pre-sample reservoir) is filled with a predetermined volume of bodily fluid and the user rotates the dial (actuator) to begin drawing additional sample, the dial (actuator) cannot be moved back to establish fluid communication with the first sample volume (contained within the pre-sample reservoir).

[0141]

[1194] While several embodiments have been described above, it should be understood that they are presented by way of example only, and not by way of limitation. While various embodiments have been described as including certain combinations of features and / or components, other embodiments are possible having any combination or subcombination of any features and / or components from any of the embodiments described herein. For example, while the collection device 700 is shown and described with reference to FIGS. 34-40 as having a first, second, third, fourth, or fifth configuration, in other embodiments, the collection devices described herein can have more or fewer configurations. Furthermore, while the collection device 200 is shown and described with reference to FIGS. 2-13 as having a vacuum-assisted collection tube as the pre-sample reservoir 270, in other embodiments, the collection device 200 can have a chamber contained within the housing 201 similar to the collection device 400 of the embodiment presented in FIGS. 16-22, including the pre-sample reservoir 470, which is a chamber contained within the distribution member 429, or vice versa.

[0142]

[1195] The specific configuration of the various components may also be varied. For example, the size and specific shape of the various components may differ from the illustrated embodiment while still providing the functionality as described herein. More specifically, the size and shape of the various components may be specifically selected for a desired rate of flow of bodily fluid into the fluid reservoir. For example, while flow metering mechanism 967 is specifically shown in FIG. 49, any of the collection devices described herein may be used with any suitable flow metering mechanism. For example, in some embodiments, the collection device may include a flow metering mechanism and / or any other mechanism, device, or method configured to measure volumetric characteristics of bodily fluids, such as, for example, a pressure sensor, a voltage sensor, an optical sensor, a velocity sensor, a flow meter, a strain gauge, a valve, a turbine, a float, displacement analysis, density analysis, gravimetric analysis, optical analysis, ultrasonic analysis, thermal analysis, Doppler analysis, electromagnetic field (emf) analysis, reflectance analysis, obstruction analysis, area analysis, Venturi analysis, Coriolis analysis, visual analysis, and / or any other suitable sensor, analysis, and / or calculation (e.g., applying and / or using Boyle's law, ideal gas law, force calculations (force = mass x acceleration), etc., by way of example).

Claims

1. 1. A device for obtaining a bodily fluid sample from a patient, comprising: a distribution member forming at least a portion of the pre-sample reservoir, the distribution member defining a first fluid flow path in fluid communication with the first outlet and a second fluid flow path in fluid communication with the second outlet; a flow controller in fluid communication with the distribution member, the flow controller in a first state configured to transfer a pre-sample volume of bodily fluid from a patient to the pre-sample reservoir, the flow controller in a second state configured to transfer a first volume of bodily fluid to the first fluid flow path while bypassing the pre-sample volume of bodily fluid contained in the pre-sample reservoir, and the flow controller in a third state configured to transfer a second volume of bodily fluid to the second fluid flow path while bypassing the pre-sample volume of bodily fluid contained in the pre-sample reservoir; the flow controller is configured to transition from the first state to at least one of the second state or the third state after the pre-sample volume of bodily fluid is transferred into the pre-sample reservoir; the distribution member is coupled to at least one of a first sample reservoir after the first volume of bodily fluid has been transferred into the first fluid flow path or a second sample reservoir after the second volume of bodily fluid has been transferred into the second fluid flow path; when the distribution member is coupled to the first sample reservoir, the first outlet positions the first fluid flow path in fluid communication with the first sample reservoir to transfer a first sample volume of bodily fluid into the first sample reservoir; When the distribution member is coupled to the second sample reservoir, the second outlet positions the second fluid flow path in fluid communication with the second sample reservoir to transfer a second sample volume of bodily fluid into the second sample reservoir. The apparatus is configured to:

2. 2. The device of claim 1, wherein the pre-sample volume of bodily fluid in the pre-sample reservoir includes skin-present contaminants, and the first volume of bodily fluid and the second volume of bodily fluid transferred to the first fluid flow path and the second fluid flow path, respectively, are substantially free of skin-present contaminants.

3. The device of claim 1 , further comprising a flow metering mechanism configured to meter the flow of bodily fluid into or out of the distribution member.

4. a first movable member coupled to the distribution member, the first movable member configured to move through the first outlet to position the first fluid flow path in fluid communication with the first sample reservoir; 10. The apparatus of claim 1, further comprising: a second movable member coupled to the distribution member, the second movable member configured to move through the second outlet to position the second fluid flow path in fluid communication with the second sample reservoir.

5. 5. The apparatus of claim 4, wherein the first movable member includes a first flow metering mechanism and the second movable member includes a second flow metering mechanism, the first flow metering mechanism configured to meter flow through the first movable member from the first fluid flow path of the first sample volume to the first sample reservoir, and the second flow metering mechanism configured to meter flow through the second movable member from the second fluid flow path of the second sample volume to the second sample reservoir.

6. The apparatus of claim 1 , wherein the flow controller includes an inlet port configured to be coupled to a lumen-defining device for receiving bodily fluid from the patient.

7. 7. The device of claim 6, wherein the first fluid flow path is in fluid communication with the inlet port when the flow controller is in the second state, and the second fluid flow path is in fluid communication with the inlet port when the flow controller is in the third state.

8. 10. The device of claim 1, wherein the first volume of bodily fluid is between 0.1 milliliters and 10 milliliters, and the second sample volume of bodily fluid is between 2.5 milliliters and 60 milliliters.

9. 10. The device of claim 1, wherein the first volume of bodily fluid is between 0.1 milliliters and 10 milliliters.

10. 10. The device of claim 1, wherein the second sample volume of bodily fluid is between 2.5 milliliters and 60 milliliters.

11. 1. A system for obtaining a bodily fluid sample from a patient, comprising: a sample reservoir; a distribution member defining a fluid flow path in fluid communication with the pre-sample reservoir and the outlet, and a transfer device including a flow controller in fluid communication with the distribution member; The transfer device comprises: the flow controller in a first state is configured to transfer a pre-sample volume of bodily fluid from a patient to the pre-sample reservoir; the flow controller in the second state is configured to transfer a volume of bodily fluid to the fluid flow path while bypassing the pre-sample volume of bodily fluid contained in the pre-sample reservoir, and the flow controller is configured to transition from the first state to the second state after the pre-sample volume of bodily fluid has been transferred into the pre-sample reservoir; The outlet is arranged to fluidly connect the fluid flow path to the sample reservoir to transfer a sample volume of bodily fluid into the sample reservoir, and the distribution member is configured to be coupled to the sample reservoir after the volume of bodily fluid has been transferred into the fluid flow path. The system is configured as follows:

12. The transfer device further includes a flow metering mechanism in fluid communication with the fluid flow path, the transfer device comprising: The flow metering mechanism is configured to meter the flow of the sample volume of bodily fluid from the fluid flow path to the sample reservoir. The system of claim 11 configured to:

13. The system of claim 12 , wherein the flow metering mechanism is configured to display a volume indicator related to the sample volume of bodily fluid transferred to the sample reservoir.

14. 12. The system of claim 11, wherein the pre-sample volume of bodily fluid in the pre-sample reservoir includes skin-present contaminants, and the volume of bodily fluid transferred to the fluid flow path is substantially free of skin-present contaminants.

15. the fluid flow path is a first fluid flow path, the outlet is a first outlet, the volume of bodily fluid transferred to the first fluid flow path is a first volume of bodily fluid, the distribution member defines a second fluid flow path in fluid communication with a second outlet, and the transfer device comprises: The flow controller in a third state is configured to transfer a second volume of bodily fluid to the second fluid flow path while bypassing the pre-sample volume of bodily fluid contained in the pre-sample reservoir, and the flow controller is configured to transition from the second state to a third state after the first volume of bodily fluid is transferred to the sample reservoir. The system of claim 11 configured to:

16. The sample reservoir is a first sample reservoir, the system further includes a second sample reservoir, and the transfer device comprises: The second outlet is configured to place the second fluid flow path in fluid communication with the second sample reservoir to transfer a sample volume of bodily fluid into the second sample reservoir, and the distribution member is configured to be coupled to the second sample reservoir after the second volume of bodily fluid is transferred into the second fluid flow path. The system of claim 15 configured to:

17. 1. A system for obtaining a bodily fluid sample from a patient, comprising: a plurality of sample reservoirs; a distribution member defining a fluid flow path in fluid communication with a plurality of outlets; and a transfer device including a flow controller in fluid communication with the distribution member; The transfer device comprises: the flow controller in a first state is configured to transfer a pre-sample volume of bodily fluid from a patient to a pre-sample reservoir included in the distribution member; the flow controller in a second state is configured to transfer a volume of bodily fluid to the fluid flow path while bypassing the pre-sample volume of bodily fluid in the pre-sample reservoir; the flow controller is configured to transition from a first state to a second state after the pre-sample volume of bodily fluid is transferred into the pre-sample reservoir; The distribution member is configured to be coupled to the plurality of sample reservoirs after the volume of bodily fluid is transferred into the fluid flow path, such that each outlet of the plurality of outlets establishes fluid communication with a different sample reservoir of the plurality of sample reservoirs, allowing the sample volume of bodily fluid to be transferred from the fluid flow path into each sample reservoir of the plurality of sample reservoirs. The system is configured as follows:

18. 20. The system of claim 17, wherein the pre-sample volume of bodily fluid in the pre-sample reservoir includes skin-present contaminants, and the volume of bodily fluid transferred to the fluid flow path is substantially free of skin-present contaminants.

19. 20. The system of claim 17, wherein the distribution member is coupled to the plurality of sample reservoirs via at least one of a resistance fit, a mechanical fastener, one or more mating recesses, or a threaded connection.

20. The transfer device further includes a plurality of movable members, the transfer device comprising: Each movable member of the plurality of movable members is movably coupled to a corresponding outlet of the plurality of outlets and is positioned such that each movable member of the plurality of movable members moves from a first position to a second position through the corresponding outlet to fluidly connect the fluid flow path to a sample reservoir of the plurality of sample reservoirs coupled to the corresponding outlet. The system of claim 17 configured to:

21. 21. The system of claim 20, wherein each sample reservoir of the plurality of sample reservoirs is fluidly isolated from the fluid flow path when a corresponding movable member of the plurality of movable members associated with each sample reservoir is in the first position, and each sample reservoir of the plurality of sample reservoirs is fluidly connected to the fluid flow path when the corresponding movable member is in the second position.

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