Sterile body fluid collection device and method

Abstract

The present invention provides a device and method for obtaining body fluid samples parenterally while reducing contamination from external microorganisms or other contaminants of the body fluid source, such as microorganisms present on the skin. [Solution] The device includes a pre-sample reservoir, a flow diversion mechanism, and a flow metering mechanism. The flow diversion mechanism has an inlet port that can be coupled to a lumen-defining device to receive body fluid from a patient, a first outlet port that can be fluidly coupled to the pre-sample reservoir, and a second outlet port that can be fluidly coupled to the sample reservoir. The flow diversion mechanism defines a first fluid channel and a second channel configured to arrange the first and second outlet ports so as to be in fluid communication with the inlet port, respectively. The flow metering mechanism is configured to measure the flow of a predetermined volume of body fluid through the first fluid channel to the pre-sample reservoir, measure the flow of a second volume of body fluid through the second fluid channel to the sample reservoir, and display volume indicators related to the predetermined volume and the second volume.

Description

Technical Field

[0001] Cross - Reference to Related Applications

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

[0002]

[1002] The embodiments described herein generally relate to the parenteral procurement of bodily - fluid samples, and more particularly, to devices and methods for parenterally obtaining bodily - fluid samples while reducing contamination from microorganisms or other contaminants external to the bodily - fluid source, such as microorganisms present on the skin.

Background Art

[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 include culturing the patient sample in one or more sterile containers containing a culture medium that promotes microbial growth, and methods based on real-time diagnostics and / or molecular PCR. Generally, if such microorganisms are present in a patient sample, they will grow in the culture medium over time. After a variable time (e.g., several hours to several days), the growth of the organisms can be detected by automated continuous monitoring. Such automated monitoring can detect the carbon dioxide produced by the growth of the organisms, and the culture medium can then be tested for the presence of microorganisms. If microorganisms are present in the culture medium, it suggests the presence of the same microorganisms in the patient sample, and further suggests the presence of the same microorganisms in the bodily fluids of the patient from which the sample was taken. Therefore, if microorganisms are determined to be present in the culture medium, the patient may be prescribed one or more antibiotics or other treatments specifically designed to treat or otherwise remove the undesirable microorganisms from the patient.

[0004]

[1004] However, patient samples can be contaminated during acquisition and / or may otherwise be prone to false positive results. One process by which contamination of patient samples may occur is the transfer of microorganisms from the body surface (e.g., microorganisms present on the skin) that are removed during needle insertion into the patient's body and subsequently transferred to the culture medium along with the patient sample. Surface microorganisms and / or other undesirable external microorganisms can be removed directly or via removed tissue fragments, hair follicles, sweat glands, and other skin appendage structures. Another possible source of contamination comes from the person taking the patient sample. For example, a physician, phlebotomist, nurse, etc., may transfer contaminants from their own body (e.g., fingers, arms, etc.) to the patient sample and / or the equipment containing the patient sample. Further detailing, the equipment and / or devices used during the patient sample acquisition process (e.g., from the patient to the needle, from the needle / tube to the sample container, etc.) often contain multiple fluid interfaces, each of which can create potential sites of contamination. The use of such equipment and / or devices typically involves manual intervention to connect and / or fluidically couple various interfaces. Because these interfaces are pre-assembled and not sterilized as a single fluidically coupled system, they can be introduced into patient samples via the user (e.g., physician, phlebotomist, etc.) and / or other sources of contamination (e.g., ambient air, contaminants on the surfaces of patient room tables and counters, microorganisms transferred from linens or clothing, etc.). In some cases, such contaminants can grow in culture media and ultimately lead to positive microbiological test results, 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 predetermined volume of the patient sample. For example, overfilling volume-sensitive blood culture bottles can lead to false positive results, as noted in the instructions for use and / or warning labels from the manufacturers of such culture bottles and associated automated continuous monitoring microbial detection systems. On the other hand, as an alternative example, insufficient volume of patient sample in the culture medium can lead to false negative results. For example, in a study conducted by the Mayo Clinic titled "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 20-milliliter (mL) patient sample volume could detect approximately 80% of bacteremia present in the patient sample, a 40 mL patient sample volume could detect approximately 88% of bacteremia, and a 60 mL patient sample volume could detect approximately 99% of bacteremia.

[0006]

[1006] Such inaccurate results, resulting from contamination, insufficient patient sample volume, etc., pose problems when attempting to diagnose or treat a suspected illness or health condition. For example, false negative results from microbiological tests may lead to misdiagnosis and / or delayed treatment of a patient's illness, potentially resulting in death. Conversely, false positive results from microbiological tests may result in a patient receiving one or more antimicrobial therapies unnecessarily, causing serious side effects in the patient, including death, and resulting in unnecessary burdens and expenses on the healthcare system due to prolonged 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 standpoint, as, in addition to cost, unnecessary exposure to high-dose radiation associated with various imaging procedures (e.g., CT scans) has many known adverse effects on the patient's long-term health.

[0007]

[1007] Therefore, there is a need for sterile, "integrated" body fluid collection devices and methods that reduce microbial contamination in body fluid samples by, for example, minimizing exposure to non-sterile conditions and / or other external sources of contamination around the patient sample and / or fluid interface. Furthermore, such body fluid collection devices are required to include means for accurately weighing, measuring, and / or otherwise evaluating the body fluids transferred from the patient to a sample reservoir or culture medium, which can be communicated visually, computationally, or otherwise to healthcare workers acquiring the patient sample in substantially real time (e.g., at the patient's bedside). [Overview of the Initiative]

[0008]

[1008] This specification describes a device for parenterally obtaining a body fluid sample while reducing contamination from external microorganisms of the body fluid source, such as microorganisms present on the skin and / or other undesirable external contaminants. In some embodiments, the device for obtaining a body fluid sample from a patient includes a pre-sample reservoir, a flow divider, and a flow metering mechanism. The pre-sample reservoir is configured to receive a first volume of body fluid to be drawn from the patient. The flow divider includes an inlet port, a first outlet port, and a second outlet port, defining a first and second fluid flow path. The inlet port can be coupled to a lumen-defining device to receive body fluid from the patient. The first and second outlet ports are configured to fluidly couple the pre-sample reservoir and the sample reservoir, respectively, to the flow divider. The first fluid flow path is configured to fluidly communicate the first outlet port to the inlet port, and the second fluid flow path is configured to fluidly communicate the second outlet port to the inlet port. The flow metering mechanism is fluidly communicating with the first and second fluid flow paths. The flow metering mechanism is configured to measure the flow of a first volume of body fluid into the pre-sample reservoir through a first fluid channel, and to measure the flow of a second volume of body fluid into the sample reservoir through a second fluid channel. The flow metering mechanism is configured to display volume indicators related to the first and second volumes. [Brief explanation of the drawing]

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

[0010]

[1063] This specification describes a device for parenterally obtaining a body fluid sample while reducing contamination from external microorganisms of the body fluid source, such as microorganisms present on the skin and / or other undesirable external contaminants. In some embodiments, the device for obtaining a body fluid sample from a patient includes a pre-sample reservoir, a flow divider, and a flow metering mechanism. The pre-sample reservoir is configured to receive a first volume of body fluid to be drawn from the patient. The flow divider includes an inlet port, a first outlet port, and a second outlet port, defining a first and second fluid flow path. The inlet port can be coupled to a lumen-defining device to receive body fluid from the patient. The first and second outlet ports are configured to fluidly couple the pre-sample reservoir and the sample reservoir, respectively, to the flow divider. The first fluid flow path is configured to fluidly communicate the first outlet port to the inlet port, and the second fluid flow path is configured to fluidly communicate the second outlet port to the inlet port. The flow metering mechanism is fluidly communicating with the first and second fluid flow paths. The flow metering mechanism is configured to measure the flow of a first volume of body fluid into the pre-sample reservoir through a first fluid channel, and to measure the flow of a second volume of body fluid into the sample reservoir through a second fluid channel. The flow metering mechanism is configured to display volume indicators related to the first and second volumes.

[0011]

[1064] In some embodiments, the apparatus for obtaining a body fluid sample from a patient includes a pre-sample reservoir, a flow divider, a flow controller, and a movable member. The pre-sample reservoir is configured to receive a first volume of body fluid to be withdrawn from the patient. The flow divider includes an inlet port, a first outlet port, and a second outlet port. The inlet port can be coupled to a lumen-defining device to receive body fluid from the patient. The first outlet port fluidically couples the pre-sample reservoir to the flow divider, and the second outlet port fluidically couples the sample reservoir to the flow divider. The flow controller is at least partially located within the flow divider and can be moved between a first embodiment in which the flow controller defines at least a portion of the fluid flow path between the inlet port and the first outlet port, and a second embodiment in which the flow controller defines at least a portion of the fluid flow path between the inlet port and the second outlet port. The movable member is movably coupled to the flow diversion 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 body fluid to be withdrawn from the patient when the flow controller is in its second configuration and the movable member is in its second configuration.

[0012]

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

[0013]

[1066] In some embodiments, a method using a flowmetered transfer device having a flow splitting mechanism including an inlet port configured to be selectively positioned to provide fluid communication to a presample reservoir and a sample reservoir, and a flow metering mechanism configured to measure the flow of body fluid from a patient to the presample reservoir and to the sample reservoir, includes the step of establishing fluid communication between the patient and the inlet port of the flowmetered transfer device. Then, fluid communication is established between the port and the presample reservoir. The flow of body fluid transferred from the patient to the presample reservoir is measured. The method includes the step of verifying, via the flow metering mechanism of the flowmetered transfer device, that the presample volume of body fluid placed in the presample reservoir is a first presample volume of body fluid. With the presample volume placed in the presample reservoir, the presample reservoir is fluidically isolated from the port so that the presample volume of body fluid is sealed within the presample reservoir. With the presample reservoir fluidically isolated, the method includes the step of establishing fluid communication between the port and the sample reservoir. The flow of body fluid transferred from the patient to the sample reservoir is measured. The method includes the step of verifying that the sample volume of body fluid placed in the sample reservoir is the first sample volume of body fluid via the flow metering mechanism of a flow metering transfer device.

[0014]

[1067] In some embodiments, the apparatus includes a flow divider and a flow controller. The flow divider may define an inlet port, a first outlet port, a second outlet port, and a third outlet port. The first outlet port is fluidically coupled to a pre-sample reservoir, the second outlet port is fluidically coupled to a first sample reservoir, the third outlet port is fluidically coupled to a second sample reservoir, and so on. All fluid reservoirs can be fluidically isolated from one another. The flow controller includes various fluid channels, which can allow fluid movement in a specified direction and may be configured to be operably coupled to the flow divider. When the flow divider is in its first configuration, the flow controller can allow a flow of body fluid into the pre-sample reservoir. The flow divider can be moved to a second configuration, where the flow controller can allow a flow of body fluid into the first sample reservoir. Furthermore, the flow divider can then be moved to a third configuration, where the flow controller can allow a flow of body fluid into the second sample reservoir.

[0015]

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

[0016]

[1069] In some embodiments, the fluid collection device may include a flow meter to ensure that an appropriate volume of fluid is collected from the patient and / or transferred to a predetermined pre-sample reservoir and / or sample reservoir. The fluid collection device may be configured to automatically divert and / or control the fluid flow after the measured volume of fluid has been collected. For example, when a first measured pre-sample volume is collected, the diversion mechanism may be configured to divert the fluid flow to a first sample reservoir, and then, after the first measured sample volume is collected, the diversion mechanism may be configured to divert the fluid flow to a second sample reservoir, and so on. In some embodiments, the fluid collection device may include a measured volume display, such as a liquid crystal display (LCD), to provide the user with a visual indication of how much fluid has been collected in each predetermined individual sample reservoir. In some embodiments, multiple displays may be provided to enable customized pre-sample and / or sample volume collection.

[0017]

[1070] As used herein and in the appended claims, the singular forms “a, an” and “the” refer to multiple objects unless explicitly stated in the context. Thus, for example, the term “(a) component” is intended to mean a single component or a combination of components, and “(a) material” is intended to mean one or more materials or a combination thereof.

[0018]

[1071] As used herein, “body fluids” may include, but are not limited to, any fluids obtained from within a patient’s body, including blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, or any combination thereof.

[0019]

[1072] As used herein, the terms “first predetermined amount,” “first quantity,” and “first volume” refer to the amount of body fluid configured to be received or contained by the first reservoir or presample reservoir. The terms “first quantity” and “first volume” do not explicitly state a predetermined amount, but unless explicitly stated otherwise, the first quantity should be understood to be the first predetermined amount.

[0020]

[1073] As used herein, the terms “second quantity” and “second volume” refer to the amount of body fluid configured to be received or contained by the second reservoir or sample reservoir. The second quantity can be any suitable amount of body fluid and does not need to be a predetermined amount. Conversely, where explicitly stated, the second quantity received and contained by the second reservoir or sample reservoir may be a second predetermined amount.

[0021]

[1074] As used herein, the term “set” can refer to a single mechanism comprising multiple mechanisms or multiple parts. For example, when we say “set of walls,” we can consider the set of walls as one wall comprising separate parts, or as multiple walls. Similarly, an integrally constructed article may include a set of walls. Such a set of walls may include, for example, multiple parts that are discontinuous from one another. A set of walls may also be manufactured from multiple articles that are manufactured separately and then joined together (for example, by welding, adhesive or any preferred method).

[0022]

[1075] As used herein, the terms “proximal” and “distal” refer to the direction closer to and away from the user when positioning the device to contact the patient, respectively. Therefore, for example, the end of the device that first makes contact with the patient's body is the distal end, and the opposite end of the device (for example, the end of the device being operated by the user) is the proximal end.

[0023]

[1076] As used herein, the terms “about,” “approximately,” and “substantially,” when used in relation to numerical values, are intended to mean that the value thus defined is the nominally indicated value. In other words, when the terms about, approximately, and substantially are used in relation to numerical values, they 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 about 0.5 includes 0.45 and 0.55, about 10 includes 9 to 11, and about 1000 includes 900 to 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 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 related to measuring instruments, acceptable human error, etc.).

[0024]

[1077] When describing the relationship between a given volume of body fluid and the collected volume of body fluid, it should be understood that these values ​​include preferred tolerances, such as those mentioned above. For example, when stating that the collected volume of body fluid is substantially equal to a given volume of body fluid, the collected volume and the given volume are nominally equal within a preferred tolerance range. In some cases, tolerances can be determined by the intended use of the collected volume of body fluid. For example, in some cases, a blood culture assay may be approximately 99% accurate when the collected volume of blood is within the range of 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 body fluid assay may be 10 milliliters (mL) ± 5% per sample collection bottle (i.e., a total volume of 40 ml to 60 ml) when a total of 4 or 6 collection bottles are used, for approximately 99% confidence. Accordingly, a collection volume of 10.5 mL provides results with a confidence level of over approximately 99%, and a collection volume of 11 mL provides results with a confidence level of less than approximately 99%. In other cases, preferred tolerances 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 in between. In yet other cases, the tolerance may exceed 10.0%. Accordingly, any embodiment described herein may include and / or be used with any suitable flow measuring mechanism and / or device configured to measure the flow rate of a body fluid and / or measure the volume of a body fluid by other means within a preferred tolerance range. Furthermore, the flow measuring mechanism and / or device may be arranged to minimize or eliminate the accumulation of tolerances that may result from a combination of inaccurate measurements, human error, etc.

[0025]

[1078] Figure 1 is a schematic diagram of a part of a bodily fluid collection device 100 according to an embodiment. Generally, the bodily fluid collection device 100 (also referred to herein as the “fluid collection device” or “collection device”) is configured to allow the extraction of bodily fluids from a patient, thereby separating a first portion or volume of the extracted bodily fluid from a second portion or volume and / or a third portion or volume of the extracted bodily fluid that will be used as a biological sample, such as for examination for medical diagnostic and / or therapeutic purposes. In other words, as described in more detail herein, the collection device 100 is configured to transfer a first predetermined volume of the bodily fluid to a pre-sample collection reservoir, and a second and third volume (or, in some embodiments, a fourth, fifth, etc.) of the bodily fluid to one or more sample collection reservoirs (e.g., sample reservoirs) that are fluidically isolated from the pre-sample reservoir.

[0026]

[1079] The collection device 100 includes a flow diversion mechanism 120, a flow controller 140, a pre-sample reservoir 170, a first sample reservoir 180, and a second sample reservoir 190 distinct from the first sample reservoir 180. The flow diversion 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 Figure 1. In some embodiments, the flow diversion mechanism 120 may include a set of outlet ports equal to the total number of pre-sample reservoirs and sample reservoirs. For example, if the collection device 100 has one pre-sample and four sample reservoirs, the flow diversion mechanism 120 may include five outlet ports. In some embodiments, the flow diversion mechanism 120 may be operably coupled to an actuator (not shown in Figure 1) that can facilitate movement of the flow diversion mechanism 120 between multiple configurations. The inlet port 121 is configured to be fluidically coupled to a medical device that defines a route X for extracting bodily fluids from the patient and / or transporting them to the collection device 100. For example, the inlet port 121 can be fluidly coupled to a needle or other lumen-defining device (e.g., a flexible sterile tube). In this way, the flow diversion mechanism 120 can receive bodily fluids from the patient via a needle or any other lumen-defining device.

[0027]

[1080] The first outlet port 125 of the flow diversion mechanism 120 can be fluidically coupled to the presample reservoir 170. In some embodiments, the presample reservoir 170 is integrally formed with the first outlet port 125 and / or a portion of the flow diversion mechanism 120. In other embodiments, the presample reservoir 170 can be mechanically and / or fluidly coupled to the flow diversion mechanism 120 via adhesive, resistance fit, mechanical fasteners, any number of mating recesses, screw couplings and / or any other suitable coupling or combination thereof. Similarly, the presample reservoir 170 can be physically (e.g., mechanically) coupled to the flow diversion mechanism 120, thereby fluidly communicating the internal space (volume) defined by the presample reservoir 170 to the first outlet port 125 of the flow diversion mechanism 120. In yet another embodiment, the presample reservoir 170 can be operably coupled to the first outlet port 125 of the flow diversion mechanism 120 via an intervening structure (not shown in Figure 1), such as a flexible sterilization tube. More specifically, the intervening structure can define a lumen configured to position the presample reservoir 170 in fluid communication with the first outlet port 125.

[0028]

[1081] The presample reservoir 170 is configured to receive and contain a first predetermined volume of body fluid. In some embodiments, the presample reservoir 170 is configured to contain the first volume of body fluid so as to be fluidly isolated from a second and / or third volume of body fluid (which may or may not be the same as the first volume of body fluid) that is subsequently withdrawn from the patient. The presample reservoir 170 may be any suitable reservoir for containing body fluid, such as the presample reservoir described in detail in U.S. Patent No. 8,197,420, entitled "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination," which is incorporated herein by reference as a whole.

[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 may have a third outlet port (not shown) coupled to the second sample reservoir 190. In some embodiments, the first sample reservoir 180 can be formed integrally with the second outlet port 126 and / or a part 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 as 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 body fluid. For example, the second volume of body fluid may be the amount withdrawn from the patient following the withdrawal of the first presample volume. In some embodiments, the first sample reservoir 180 is configured to contain the second volume of body fluid such that the second volume is fluidically isolated from the first volume of presample body fluid.

[0030]

[1083] The first sample reservoir 180 and the second sample reservoir 190 may be any suitable sterile reservoir for containing body fluids, including, for example, a sample reservoir as described in the '420 patent incorporated by reference above. In some embodiments, the second volume may be any suitable volume of body fluid and does not need to be a predetermined volume. In other embodiments, the transfer of body fluid to the first sample reservoir 180 and / or the second sample reservoir 190 may be measured, etc., so 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 may be substantially the same as the first sample reservoir 180 described above. The second sample reservoir 190 can be fluidically 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 may be substantially the same as the fluid coupling of the second outlet port 126 to the first sample reservoir 180, as described in detail above. Thus, these parts are not described in further detail herein and should be considered substantially the same unless explicitly stated otherwise. Furthermore, additional outlet ports and sample reservoirs of the flow diversion mechanism 120 (not shown in Figure 1) may be substantially the same as the second outlet port 126 and the first sample reservoir 180.

[0032]

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

[0033]

[1086] In some embodiments, the collection device 100 may further include an actuator (not shown in Figure 1) and a flow controller 140 defining a first fluid channel 142, a second fluid channel 144, and optionally additional fluid channels (not shown in Figure 1). In some embodiments, the actuator may be included in the flow diversion mechanism 120 or otherwise operably coupled. Thus, the actuator can be configured to control fluid movement (e.g., between different configurations) within the flow controller 140. For example, the actuator may 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, and so on. In some embodiments, the actuator may be configured to move in one direction. For example, the actuator may be moved from its first position to its second position, but not from its second position to its first position. Similarly, the actuator may be moved from its second position to its third position, but not from its third position back to its second position. Thus, the flow controller 140 is prevented from moving to its second or third form before its first form, and therefore, it is necessary that the first volume of body fluid is directed to the pre-sample reservoir 170 and not to the sample reservoirs 180 and / or 190, which are designed to contain the second and / or third volumes of the extracted fluid to be used as a biological sample, such as for examination for medical diagnostic and / or therapeutic purposes.

[0034]

[1087] The flow controller 140 is configured such that, in the first configuration, a first fluid passage 142 fluidically connects the inlet port 121 to the first outlet port 125, and in the second configuration, a second fluid passage 144 fluidically connects the inlet port 121 to the second outlet port 126. In some embodiments, the actuator described above can be configured to move the flow controller 140 in translational motion between the first and second configurations, and optionally between the third or fourth configuration. For example, in some embodiments, the flow controller 140 may be in the first configuration when it is distal to the collection device 100. In such embodiments, the actuator can be operated to move the flow controller 140 proximal to a position close to the collection device 100, thereby positioning the flow controller 130 in the second configuration. In other embodiments, the actuator can also be operated to move the flow controller 140 in rotational motion between the first and second configurations, or optionally between the third or fourth configuration.

[0035]

[1088] Therefore, when the flow controller 140 is in its first configuration, the second outlet port 126 (and optionally, additional outlet ports connected to the sample reservoir) is fluidically isolated from the inlet port 121. Similarly, when the flow controller 140 is in its second configuration, the first outlet port 125 is fluidically isolated from the inlet port 121. Optionally, when the flow controller 140 is in its third configuration (not shown in Figure 1), the first outlet port 125 and the second outlet port 126 are fluidically isolated from the inlet port 121. Thus, when the flow controller 140 is in its first configuration, it can direct or divert a first volume of body fluid to the pre-sample fluid reservoir 170 via the first outlet port 125, and when it is in its second configuration, it can direct or divert a second volume of body fluid to the first sample fluid reservoir 180 via the second outlet port 126.

[0036]

[1089] In some embodiments, at least a portion of the actuator can be operably coupled to the pre-sample fluid reservoir 170. Thus, the actuator (or at least a portion of the actuator) can be configured to induce or otherwise facilitate the creation of a vacuum within the “pre-sample” fluid reservoir 170, thereby initiating a flow from the bodily fluid collection device 100 into the pre-sample fluid reservoir 170 when the flow diversion mechanism 120 is in its first embodiment. The actuator may include any suitable mechanism for driving the flow of bodily fluid into the collection device 100, such as a rotating disk, plunger, slide, dial, button, handle, 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, the flow diversion mechanism 120 may be configured such that a first volume of body fluid must be transported to the pre-sample fluid reservoir 170 before a second volume of body fluid can be transported through the flow diversion mechanism 120 to the first sample fluid reservoir 180 and / or to the second sample fluid reservoir 190. Thus, the flow diversion mechanism 120 can be characterized as requiring compliance by healthcare workers regarding the collection of a first predetermined volume of body fluid (e.g., a pre-sample) before collecting a second and / or third volume of body fluid (e.g., a sample). Similarly, the flow diversion mechanism 120 may be configured to prevent healthcare workers from collecting a second volume of body fluid, i.e., a sample, into the first sample fluid reservoir 180 without first diverting the first volume of body fluid, i.e., a pre-sample, into the pre-sample reservoir 170. Thus, healthcare workers are prevented from including (intentionally or unintentionally) a first volume of body fluid that is more likely to contain surface microorganisms and / or other undesirable external contaminants in the body fluid sample used for analysis. In other embodiments, the fluid collection device 100 does not need to include any mandatory compliance features or components.

[0038]

[1091] In some embodiments, the flow diversion mechanism 120 may have a fourth configuration (not shown in Figure 1) that differs from the first, second, and third configurations. In the fourth configuration, the flow diversion mechanism 120 can simultaneously fluidly isolate the inlet port 121 from the first outlet port 125, the second outlet port 126, and optionally the third outlet port. Thus, when the flow diversion mechanism 120 is in its fourth configuration, bodily fluids are prevented from flowing from the inlet port 121 to the pre-sample fluid reservoir 170, the first sample fluid reservoir 180, and the second sample fluid reservoir 190. During use, for example, the flow diversion mechanism 120 can be activated (e.g., manually or automatically) to position it in a first configuration so that body fluid can flow from the inlet port 121 to the pre-sample fluid reservoir 170; then it can be moved to a second configuration so that body fluid can flow from the inlet port 121 to the first sample fluid reservoir 180; optionally, it can be moved to a third configuration so that body fluid can flow from the inlet port 121 to the second sample fluid reservoir 190; and then it can be moved to a fourth configuration so that the flow of body fluid into and / or through the flow diversion mechanism 120 is stopped. In this way, the device is effectively "locked" and self-contained in the fourth configuration so that any residual body fluid in the device 100 is prevented from contaminating and / or otherwise exposing healthcare workers and / or patients to potentially hazardous fluids. This optional safety feature can prevent potential exposure to body fluid samples that may be infected with pathogens such as HIV, hepatitis C, etc.

[0039]

[1092] In some embodiments, one or more parts of the collection device 100 are housed within a housing (not shown in Figure 1). For example, in some embodiments, at least a portion of one or more of the flow diversion mechanism 120, the first pre-sample reservoir 170, and the sample reservoirs 180 and 190 may be housed within the housing. In such embodiments, at least a portion of the flow diversion mechanism 120 is accessible through the housing so that a user can operate the flow controller 140 to control the flow of bodily fluids from the patient (e.g., 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 may optionally include one or more flow metering devices capable of measuring the flow of bodily fluids through the collection device. For example, a flow metering device may communicate with a first fluid channel 142 and / or a second fluid channel 144 to measure the flow of bodily fluids passing through it. In other embodiments, a flow metering device may communicate with a first port 125 and / or a second port 126 and / or be positioned therein in other ways. The flow metering device may include an indicator, etc. (e.g., an electrical signal output device such as a dial, display, color, tactile output device, wireless radio signal, Bluetooth radio signal) that can be configured to provide the user with an indication 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 device may be operably coupled to an actuator, etc., as described above. In these embodiments, the flow metering device may be operable to actuate an actuator to move the flow controller 140 between its first and second forms based on a desired volume of body fluid flowing through the flow metering device. Thus, using the flow metering device, it is possible to ensure that a desired volume of body 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 in, for example, microbiological testing of patient samples.

[0041]

[1094] Referring here to Figures 2 to 13, the collection device 200 includes a flow diversion mechanism 220, a flow controller 240, a pre-sample reservoir 270, a first sample reservoir 280, and a second sample reservoir 290 distinct from the first sample reservoir 280. As further described herein, the collection device 200 can be moved between the first, second, and third forms to deliver a flow of bodily fluids that is substantially free of extracorporeal microorganisms, such as microorganisms present on the skin and / or other undesirable external contaminants. The collection device 200 can be any preferred shape, size, or configuration. For example, although Figures 2 to 13 show the sample reservoirs 280 and / or 290 oriented perpendicular to the housing 201, the collection device 200 may have sample reservoirs 280 and / or 290 oriented planar to the housing 201 or arranged conically to the housing 201.

[0042]

[1095] The flow diversion mechanism 220 includes a housing 201 and movable members 250 and 250'. As shown in Figures 2 to 4, the housing 201 is coupled to a pre-sample reservoir 270, a first sample reservoir 280, and a second sample reservoir 290. The housing 201 includes an inlet port 221, a first outlet port 230, a second outlet port 231, and a third outlet port 232, and defines an internal flow path 235 that can define a fluid flow path for collecting body fluids from a patient. The inlet port 221 can be selectively positioned to communicate fluidly with the internal flow path 235. More specifically, the inlet port 221 defines an inlet lumen 202 that can be positioned to communicate fluidly with the internal flow path 235. Thus, the inlet port 221 extends from a portion of the housing 201 so that the internal flow path 235 can be positioned to communicate fluidly with a space substantially outside the housing 201 via the inlet lumen 202. The inlet port 221 can be fluidically coupled to a medical device (not shown) that defines a fluid channel for extracting bodily fluids from a patient and / or transporting them to a collection device 200. For example, the inlet port 221 can be fluidically coupled directly or indirectly to a needle or other lumen defining device (e.g., a flexible sterile tube) via an adapter 204. Similarly, the inlet lumen 202 defined by the inlet port 221 is configured to fluidly communicate with the lumen defined by the lumen defining device when the lumen defining device is coupled to the inlet port 221. More specifically, when the lumen defining device is located within a part of the patient's body (e.g., within a patient's vein or spinal cavity), the internal channel 235 of the housing 201 can be configured to fluidly communicate with that part of the patient's body.

[0043]

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

[0044]

[1097] The movable members 250 and 250' are configured to be operated (e.g., moved) by the user from first and second positions relative to the housing 201 to direct the fluid flow into the first sample reservoir 280 and the second sample reservoir 290. The movable members 250 and 250' are substantially the same and are therefore described in reference to a single movable member 250. As shown in Figure 5, the movable member 250 includes a boss 251 defining an internal cavity 252, an inlet port 253, a first outlet port 254, and a perforating member 255 defining a lumen 256 fluidly coupled to the internal cavity 252. The inlet port 253 and the outlet port 254 extend through the wall of the boss 251 defining the internal chamber 252 of the movable member 250. The movable member 250 is configured to be attached to the support 257 (see Figure 4) of the housing 201 such that the boss 251 is located within the bore 258 (see Figure 4) and at least a portion of the movable member 250 is located within the annular chamber 260. Optionally, a biasing member 259 (e.g., a spring) can be located within the annular chamber 260 to return the movable member 250 to its first position after it has been operated by the user. In some embodiments, the movable member 250, the annular chamber 260, the bore 258, or the boss 251 may include a mechanical locking mechanism configured to hold the movable member 250 in a second position (e.g., a pressed position) after it has been operated by the user.

[0045]

[1098] As described herein, in the first embodiment, the movable member 250 is positioned at a distance from the internal flow path 235. In this embodiment, it is not possible to establish a fluid flow path between a part of the patient's body (e.g., a vein, spinal cavity, etc.) and the sample reservoirs 280 and / or 290. In other words, when the movable member 250 is in its first embodiment, the first sample reservoir 280 and the second sample reservoir 290 are fluidly isolated from the internal flow path 235 defined by the housing 201. The movable member 250 can be actuated by the user to move it from the first embodiment to the second embodiment and to align with the internal flow path 235. The force applied by the user may be sufficient to deform (e.g., compress) the biasing member 259, thereby allowing the perforating member 255 to be inserted into the sample reservoirs 280 and / or 290. In the second embodiment, the inlet port 253 and outlet port 254 are substantially aligned with the internal flow path 235, and the internal cavity 252 is positioned to fluidly communicate with the internal flow path 235. Thus, when the movable member 250 is in the second embodiment, a fluid flow path is established between the internal flow path 235, the internal cavity 252, the lumen 256 of the perforating member 255, and the sample reservoir 280. In other words, in such an embodiment, as will be described in more detail herein, body fluids can flow from the patient (e.g., veins, spinal cavity, etc.) through the diversion mechanism 220 into the first sample reservoir 280 and / or the second sample reservoir 290.

[0046]

[1099] The presample reservoir 270 can be any suitable reservoir for containing bodily fluids, such as a single-use disposable collection tube or a vacuum collection tube. The presample reservoir 270 is configured to be fluidically coupled to the first outlet port 230 of the collection device 200 in any suitable way (directly or via an intervening structure such as a sterile flexible tube). For example, in some embodiments, a portion of the presample reservoir 270 can form a friction fit within a portion of the first outlet port 230. In other embodiments, the presample reservoir 270 can be coupled to the first outlet port 230 via a screw connection, adhesive, snap fit, mechanical fastener and / or any other suitable coupling method. In some embodiments, the presample reservoir 270 can be formed integrally with the housing 201. The presample reservoir 270 can be configured to maintain a negative pressure (vacuum) inside (the presample reservoir 270) which allows body fluid to be drawn into the presample reservoir 270 via vacuum aspiration from the inlet port 221 through the outlet port 230. The presample reservoir 270 is configured to contain a first volume of body fluid, which may be a predetermined or undetermined amount, thereby fluidically separating the first volume of body fluid from second and / or third volumes of body fluid to be later withdrawn from the patient.

[0047]

[1100] The sample reservoirs 280 and / or 290 may be any suitable reservoir for containing body fluids, including single-use disposable collection tubes, vacuum collection tubes, and sample reservoirs as described in the '420 patent incorporated herein by reference above. In some embodiments, the sample reservoirs 280 and / or 290 may be substantially similar to or identical to known sample containers, such as Vacutainer®. The sample reservoirs 280 and 290 each include sample containers 282 and 292, and each includes a vacuum seal 284 and 294. The vacuum seal 284 or 294 maintains a negative pressure state (vacuum state) inside each sample container 282 or 292, which allows body fluids to be drawn into each sample container 282 or 292 from the internal flow path 235 via vacuum suction. The sample containers 280 and / or 290 can be configured to be fluidically coupled (directly or via an intervening structure such as a sterile flexible tube) in any suitable manner to the second outlet port 231 and the third outlet port 232 of the collection device 200, respectively. The sample reservoirs 280 and / or 290 can be moved relative to the outlet ports 231 and / or 232 to be in fluid communication with the outlet ports 231 and / or 232. The sample reservoirs 280 and 290 can be configured to contain a second or third volume of body fluid. The second or third volume of body fluid can be a predetermined amount or undetermined, thereby fluidically separating the second or third volume of body fluid from the first volume of body fluid drawn from the patient. In some configurations, the sample reservoirs 280 and / or 290 can be coupled to the collection device 200 by forming them integrally with the housing 201, similar to the pre-sample reservoir 270, and therefore these are not described in detail here. In some cases, the sample reservoirs 280 and / or 290 can be made transparent, thereby providing the user with visual feedback to confirm the flow of bodily fluids into the sample reservoirs 280 and / or 290.

[0048]

[1101] In some embodiments, the sample reservoirs 280 and 290 and the flow divider 220 (and / or parts of the collection device 200 other than the sample reservoirs 280 and 290) are formed independently (e.g., not integrally) and joined together, for example, during the manufacturing process. In some cases, the sample reservoirs 280 and 290 can be joined to the flow divider 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 divider 220 is substantially sterilized before use. Furthermore, the collection device 200 can be transported and / or stored in a pre-assembled manner, for example, to maintain a substantially sterile interface between the sample reservoirs 280 and 290 and the flow divider 220.

[0049]

[1102] As shown in Figures 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 positioned in a recess 266 of the housing 201 (see, for example, Figure 4), and the first member 241 can be made from any biocompatible material, such as titanium, graphite, pyrolytic carbon, polyester, polycarbonate, polyurethane, or elastomer material. In some embodiments, the second member 245 acts as an actuator to move the first member 241 from a first configuration to a second configuration. More specifically, once the first member 241 is positioned in the recess 266, the second member 245 can be moved between a first and second position to move the flow controller 240 between a first and second configuration. In some embodiments, the housing 201 can selectively restrict the movement of the second member 245 from its first position to its second position. In some embodiments, the housing 201 may be configured to prevent the second member 245 from moving once it has moved to a second position. In other words, the housing 201 may include a locking mechanism to prevent the second member 245 from moving back from the second position to the first position. The second member 245 and / or the housing 201 may also include mechanical stoppers and / or other indicators that provide visual or tactile feedback to ensure accurate positioning of the second member 245.

[0050]

[1103] The first member 241 may include a plurality of channels that direct fluid flow following venipuncture (and / or other means of accessing the patient's body fluids). For example, as shown in Figures 6 and 7, the first member 241 includes a first channel 242 and a second channel 244. When the second member 245 is in a first position (see, for example, Figures 8 and 9), the flow controller 240 is configured in a first configuration, with the first channel 242 establishing fluid communication between the inlet port 221 and the first outlet port 230 while fluidly isolating the inlet port 221 from the internal channel 235. When the second member 245 is in a second position (see, for example, Figures 10 to 13), the flow controller 240 is configured in a second configuration, with the second channel 244 establishing fluid communication between the inlet port 221 and the internal channel 235 while fluidly isolating the inlet port 221 from the first outlet port 230. To further direct / isolate fluid flow between the patient and the collection device 200, the configuration may include additional first member 241 flow paths and / or positions of additional second member 245 corresponding to a flow controller 240. For example, the second member 245 may have a third position corresponding to a third form of the flow controller 240 that substantially prevents fluid flow between the patient and the collection device 200 overall. In other words, in some embodiments, after all bodily fluid samples have been removed from the patient, the dial can be moved to the third position to substantially seal the samples in the collection device 200 from the external environment.

[0051]

[1104] During operation, the collection device 200 can be used to collect body fluids (e.g., blood) from a patient while reducing contamination from microorganisms and / or other undesirable external contaminants present on the skin. For example, the inlet port 221 of the collection device 200 is fluidically coupled to a needle or other lumen-defining device (e.g., a flexible sterile tube) via an adapter 204. Following venipuncture (or other method of accessing body fluids), the second member 245 is rotated until it reaches the first position, as shown in Figures 8 and 9. Alternatively, the second member 245 can be pre-set to the first position, and the collection device 200 can be sealed in other ways to maintain the vacuum in the pre-sample reservoir 270 and the sterility of the collection device 200. For example, the inlet port 221 and / or adapter 204 may include a valve that is opened when the collection device 200 is coupled to a needle or other lumen-defining device.

[0052]

[1105] As described above, when the second member 245 is in the first position, the flow controller 240 is arranged in the first configuration, and the first flow path 242 of the first member 241 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. Furthermore, the first sample reservoir 280 and the second sample reservoir 290 are fluidly isolated from the inlet port 221 in the first configuration, and a fluid flow path is defined between a part of the patient's body (e.g., a vein) and the pre-sample reservoir 270, as indicated by arrow AA in Figure 9. As described above, the fluid reservoirs used in the collection device 200, such as the pre-sample reservoir 270 and sample reservoirs 280 and 290, are subjected to negative pressure (i.e., a pressure lower than the fluid pressure of the body part from which the collection device 200 is used to extract body fluid). This ensures that once fluid communication is established between the patient's body part (e.g., a vein) and the pre-sample reservoir 270, the negative pressure within the pre-sample reservoir 270 draws body fluid into it due to the pressure difference between the pre-sample reservoir 270 and that part of the patient's body. In this first embodiment, the flow controller 240 also fluidly isolates the pre-sample reservoir 270 from the internal flow path 235. Thus, a first volume (determined or undetermined) of body fluid can be received into the pre-sample reservoir 270 immediately after (e.g.) venipuncture and isolated from subsequent samples. In this way, the collection device 200 can be used to ensure that a first volume of body fluid most likely to contain surface microorganisms and / or other undesirable external contaminants does not contaminate subsequent volumes of body fluid samples collected and used for diagnostic or other tests that may be affected by the contaminants.

[0053]

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

[0054]

[1107] With the flow controller 240 in the second configuration, the user can operate the movable member 250 and / or 250' from the first position to the second position (i.e., by pressing it) to establish fluid communication between a part of the patient's body (e.g., a vein) and the first sample reservoir 280 and / or the second sample reservoir 290. More specifically, the movable member 250 moves from its first position to its second configuration so that the perforating member 255 passes through the outlet port 231, as indicated by arrow CC in Figure 12, so that the perforating member 255 can puncture the vacuum seal 284 of the first sample reservoir 280 and be positioned inside the sample container 282. When in the second position, the inlet port 253 and 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 fluids to flow from the internal flow path 235 into the internal cavity 252 of the movable member 250 and out of the lumen 256 of the perforating member 255 into the first sample reservoir 280. The pressure difference between the sample reservoir 280 (e.g., vacuum or negative pressure) and the internal flow path 235 draws the bodily fluids into the sample reservoir 280. In other words, in the second embodiment, as indicated by arrow DD in Figure 12, the movable member 250 establishes a fluid flow path between the internal flow path 235 and the first sample reservoir 280. Once a desired amount (e.g., a second amount) of bodily fluids has been collected in the first sample reservoir 280, the user can release the movable member 250, allowing the biasing member 259 to move the button back to its first position. When the movable member 250 returns to its first position, the perforating member 255 is removed from the first sample reservoir 280, and the seal 284 (e.g., a self-sealing septum) fluidly isolates the first sample reservoir 280 from the internal flow path 235.

[0055]

[1108] Similarly, while the flow controller 240 is in the second embodiment, the user can operate (press) the movable member 250' from its first position to its second position, as indicated by arrow EE in Figure 13. In this way, fluid communication is established between a part of the patient's body (e.g., a vein) and the second sample reservoir 290 (via the outlet port 232) in the same manner as with the movable member 250 and the first sample reservoir 280 described above. In other words, in the second embodiment, the movable member 250' establishes a fluid flow path between the internal flow path 235 and the second sample reservoir 290, as indicated by arrow FF in Figure 13. Once a desired amount of body fluid (e.g., a third amount) has been collected in the second sample reservoir 290, the user can release the movable member 250', allowing the biasing member 259' to move the button 250' back to its first position. Although shown and described as a sequential process, the order and / or ordering 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, once the flow controller 240 moves to the second configuration, the first sample reservoir 280 and the 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 time intervals in which they partially overlap. For example, the user can start filling the first sample reservoir 280, and then, after the first sample reservoir 280 is partially filled, the user can press the movable member 250' to start filling the second sample reservoir 290 while the first sample reservoir 280 is finishing filling. Furthermore, the volume of body fluids collected in the sample reservoirs 280 and / or 290 can be adjusted by repeatedly operating (inserting) the movable members 250 and / or 250'. As described above, the second member 245 may have a third position corresponding to a third form of the flow controller 240, thereby substantially preventing fluid flow between the patient and the collection device 200 and substantially sealing the sample in the collection device 200 from the external environment.

[0056]

[1109] Although not shown in Figures 2 to 13, the collection device 200 may include a flow metering device configured to measure the volume of body fluids 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 that is in fluid communication with the first flow path 242 and the second flow path 244. In other embodiments, the flow metering device may be placed in the internal cavity 252 of the movable member 250 and / or 250'. Thus, the volume of body fluid samples transferred to and placed in the first sample reservoir 280 and the second sample reservoir 290 can be measured and / or controlled so that the volume of body fluid samples placed in each sample reservoir 280 and 290 is a predetermined volume, such as 10 mL, 20 mL, or 30 mL.

[0057]

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

[0058]

[1111] As shown in Figures 14 and 15, the collection device 300 includes a flow distribution mechanism 320, a flow controller 340, a pre-sample reservoir 370, a first sample reservoir 380, a second sample reservoir 380', a third sample reservoir 390, and a fourth sample reservoir 390'. The pre-sample reservoir 370 may be substantially the same as the pre-sample reservoir 270 described in detail above. In some embodiments, the sample reservoirs 380, 380', 390, and 390' may be substantially the same as the sample reservoirs 280 and 290 described in detail above. In some embodiments, the sample reservoirs 380, 380', 390, and 390' may have substantially the same shape and size and may contain, for example, substantially the same culture medium. In other embodiments, the sample reservoirs 380, 380', 390, and 390' may have substantially the same shape and size and may contain either aerobic or anaerobic culture medium. For example, in some embodiments, the first sample reservoir 380 and the third sample reservoir 390 may contain aerobic culture media, and the second sample reservoir 380' and the fourth sample reservoir 390' may contain anaerobic culture media. In other embodiments, the sample reservoirs 380, 380', 390, and 390' may each contain aerobic culture media or anaerobic culture media in any arrangement or combination.

[0059]

[1112] The flow diversion mechanism 320 includes a housing 301 and a set of movable members 350, 350', 350'', and 350'''. The movable members 350, 350', 350'', and 350''' are substantially the same as the movable member 250 described above, for example with reference to Figure 5. Thus, the movable members 350, 350', 350'', and 350''' can be moved between a first position and a second position relative to the housing 301 so as to be in fluid communication with the sample reservoirs 380, 380', 390, and 390', respectively. The housing 301 includes an inlet port 321, a first outlet port 330 configured to communicate fluidly with a pre-sample reservoir 370, a second outlet port 331 configured to communicate fluidly with a first sample reservoir 380, a third outlet port 332 configured to communicate fluidly with a second sample reservoir 380', a fourth outlet port 333 configured to communicate fluidly with a third sample reservoir 390', and a fifth outlet port 334 configured to communicate fluidly with a fourth sample reservoir 390'. Furthermore, the housing 301 defines internal flow paths 335 that can be selectively configured to communicate fluidly with the inlet port 321 and the outlet ports 331, 332, 333, and 334 in a manner similar to that described above with respect to the internal flow paths 235 of the housing 201.

[0060]

[1113] The flow controller 340 is substantially the same as the flow controller 240 described above, for example, with reference to Figures 6 to 13. Thus, by rotating the flow controller 340 between the first and second forms, a portion of the fluid flow path between the patient and the pre-sample reservoir 370 or the sample reservoirs 380, 380', 390, and 390' can be selectively defined. In this way, the user can operate the collection device 300 in the same manner as described above with respect to the collection device 200 in Figures 8 to 13. Thus, a first volume of body fluid can be transferred to and placed in the pre-sample reservoir 370, and subsequent volumes of body fluid can be transferred to and placed in the sample reservoirs 380, 380', 390, and 390'.

[0061]

[1114] Figures 16 to 22 show a collection device 400 according to an embodiment. The collection device 400 includes a flow divider 420, a flow controller 440, and sample reservoirs 480, 480', 490, and 490'. As further described herein, the collection device 400 can be moved between the first, second, third, fourth, and fifth embodiments to deliver a stream of body 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 any preferred shape, size, or configuration. For example, in Figures 16 to 22, the sample reservoirs 480, 480', 490, and 490' are shown oriented perpendicular to the housing 401, but the collection device 400 may have sample reservoirs 480, 480', 490, and 490' oriented in any preferred plane relative to the housing 401, or arranged conically relative to the housing 401.

[0062]

[1115] Sample reservoirs 480, 480', 490, and 490' are substantially similar in form and function to or identical to sample reservoirs 280 and / or 290 of the collection device 200 and are therefore not described in detail herein. As described above, sample reservoirs 480, 480', 490, and 490' maintain a negative pressure state (vacuum state) which allows body fluids to be drawn from the patient into sample reservoirs 480, 480', 490, and 490' via suction. In some embodiments, sample reservoirs 480 and 480' can be used as culture bottles for aerobic bacteria, and sample reservoirs 490 and 490' can be used as culture bottles for anaerobic bacteria, and multiple aerobic blood culture samples and multiple anaerobic blood culture samples can be collected from a single venipuncture using the collection device 400. As will be described in more detail herein, sample reservoirs 480, 480', 490, and 490' can each be arranged to fluidly communicate with at least a portion of the flow diversion mechanism 420 to receive a certain volume of a body fluid sample. The volume of the body fluid sample may be a predetermined amount or undetermined. Furthermore, once a desired volume of body fluid is placed in the sample reservoirs 480, 480', 490, and 490', each sample reservoir 480, 480', 490, and 490' can be fluidly isolated from at least a portion of the flow diversion mechanism 420, as will be described in more detail herein.

[0063]

[1116] The flow diversion mechanism 420 includes a housing 401 and a distribution member 429. The housing 401 of the flow diversion mechanism 420 is physically and fluidly coupled to the distribution member 429 and provides and / or defines a set of fluid flow paths for collecting bodily fluids from a patient. The housing 401 defines a recess 466 and a set of outlet openings 403. The recess 466 is configured to receive a sealing member 441 included in the flow controller 440, as will be described in more 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 different fluid flow paths that are in fluid communication with different parts of the distribution member 429. More specifically, the distribution member 429 defines and / or forms at least a portion of the presample reservoir 470 which is in fluid communication with the first outlet opening 403a, a first flow path 435a which is in fluid communication with the second outlet opening 403b, a second flow path 435b which is in fluid communication with the third outlet opening 403, a third flow path 435c which is in fluid communication with the fourth outlet opening 403d, and a fourth flow path 435 which is in fluid communication with the fifth outlet opening 403e.

[0064]

[1117] As shown in Figures 17 and 18, the distribution member 429 defines a chamber or space that defines at least a portion of the presample reservoir 470. The presample reservoir 470 is configured to contain, for example, body fluids 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 presample reservoir 470 so that the presample reservoir 470 can receive a flow of body fluid from the patient. For example, the presample reservoir 470 can receive and contain a first amount or first volume of body fluid, where the first amount of body fluid can be a predetermined amount or undetermined amount. Furthermore, the arrangement of the flow distribution mechanism 420 can be such that the presample reservoir 470 is maintained in fluidic isolation from the flow paths 435a, 435b, 435c, and 435d and / or subsequent volumes of body fluid drawn from the patient, as will be described in more detail herein. Although presample reservoirs 270 and 370 are described above as maintaining negative pressure, presample reservoir 470 does not maintain a negative pressure state (vacuum state), and therefore, body fluids can be drawn into presample reservoir 470 using other mechanisms, such as gravity.

[0065]

[1118] The fluid channels 435a to 435d extend radially from the center of the distribution member 429, and each of the fluid channels 435a, 435b, 435c, and 435d is arranged to be fluidly isolated from the presample reservoir 470 and other fluid channels. In this way, the fluid channels 435a, 435b, 435c, and 435d can direct and / or otherwise define the fluid flow path between a first end and a second end that are substantially aligned with the outlet openings 403b, 403c, 403d, and 403e, respectively. As shown in Figures 17 and 18, the distribution member 429 defines a first outlet port 431 located at the second end of the first fluid channel 435a, a second outlet port 432 located at the second end of the second fluid channel 435b, a third outlet port 433 located at the second end of the third fluid channel 435c, and a fourth outlet port 434 located at the second end of the fourth fluid channel 435d. Furthermore, the distribution member 429 includes a first perforating member 455a, a second perforating member 455b, a third perforating member 455c, and a fourth perforating member 455d, which are physically and fluidly coupled to the first outlet port 431, the second outlet port 432, the third outlet port 433, and the fourth outlet port 434, respectively. Thus, as will be described in more detail herein, the perforating members 455a to 355d can be used to puncture the vacuum seals of the sample reservoirs 480, 480', 490, and 490', thereby initiating the flow of bodily fluids. Although not shown in Figures 17 and 18, the sample reservoirs 480, 480', 490, and 490' can be physically coupled (directly or via an intervening structure such as a sterile flexible tube) to a portion of the dispensing member 429 in any preferred manner that allows the sample reservoirs 480, 480', 490, and 490' to be arranged so as to be in fluid communication with the outlet ports 431, 432, 433, and 434, respectively.

[0066]

[1119] The flow controller 440 includes a dial 445 and a sealing member 441. The sealing member 441 is positioned within a recess 466 of the housing 401 (see, for example, Figure 20). More specifically, the flow controller 440 can be coupled to the housing 401 such that the sealing member 441 is positioned between and in contact with the surface of the housing 401 defining the recess 466 and the surface of the dial 445. Furthermore, the sealing member 441 may have a size and shape such that, when the flow controller 440 is coupled to the housing 401, the sealing member 441 forms a substantially fluid-sealed seal with the surface of the dial 445 and the surface of the housing 401 defining the recess 466, as described in further detail herein. The sealing member 441 can be made from any biocompatible material, such as silicone, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer (PLGA), polyacid anhydride, polyorthoester, polyetherester, polycaprolactone, polyesteramide, 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), chlorosulfonate polyolefin, polyethylene oxide, and / or mixtures and copolymers thereof.

[0067]

[1120] As shown in Figure 17, the sealing member 441 defines a set of openings 444 that can direct the flow of bodily fluids following venipuncture (or other means of accessing bodily fluids). For example, the set of openings 444 defined by the sealing member 441 includes a first opening 444a, a second opening 444b, a third opening 444c, a fourth opening 444d, and a fifth opening 444e. The arrangement of the sealing member 441 is such that, when the sealing member 441 is positioned within the recess 446, the first opening 444a, the second opening 444b, the third opening 444c, the fourth opening 444d, and the fifth opening 444e are substantially aligned with the first outlet opening 403a, the second outlet opening 403b, the third outlet opening 403c, the fourth outlet opening 403d, and the fifth outlet opening 403e of the housing 401, respectively.

[0068]

[1121] The dial 445 of the flow controller 440 is rotatably coupled to the housing 401 and is movable between first, second, third, fourth, and fifth positions relative to the housing 401. The dial 445 includes an inlet port 421 that defines a lumen 402. The inlet port 421 can be fluidically coupled to a medical device (not shown) that defines a fluid flow path for extracting bodily fluids from a patient's body and / or transporting them to a collection device 400. For example, the inlet port 421 can be fluidically coupled directly or indirectly via an adapter 404 to a needle or other lumen defining device (e.g., a flexible sterile tube). Similarly, the inlet lumen 402 defined by the inlet port 421 is positioned to fluidly communicate with the lumen defined by the lumen defining device when the lumen defining device is coupled to the inlet port 421. Thus, 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' to be in fluid communication with the patient, as will be described in more detail herein.

[0069]

[1122] As described above, the dial 445 is movable between the first, second, third, fourth, and fifth positions. When the dial 445 is in the first position, the flow controller 440 is positioned in the first configuration, and the inlet port 421 can be substantially aligned with the first opening 444a of the sealing member 441 and the first outlet opening 403a of the housing 401. In this way, the first opening 444a of the sealing member 441 fluidly isolates the inlet port 421 from the outlet openings 403b, 403c, 403d, and 403e, thereby fluidly isolating the inlet port 421 from the flow paths 435a to 335d while establishing fluid communication between the inlet port 421 and the first outlet opening 403a. When the first outlet port 403a is aligned with the open portion of the presample reservoir 470, the first opening 444a and the first outlet opening 403a establish fluid communication between the inlet port 421 and the presample reservoir 470. When the dial 445 is rotated (or driven) to the second position, the flow controller 440 is positioned in a second configuration, and the second outlet opening 444b establishes fluid communication between the inlet port 421 and the second outlet opening 403b, while fluidly isolating the inlet port 421 from the outlet openings 403a, 403c, 403d, and 403e. When the second outlet opening 403b is aligned with the first end of the first flow path 435a, the second opening 444b and the second outlet opening 403b establish fluid communication between the inlet port 421 and the 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 positioned to communicate fluidly with the patient (for example, via a medical device coupled to the inlet port 421), the first outlet port 430, second outlet port 431, third outlet port 432, fourth outlet port 433, and fifth outlet port 434 can be selectively positioned to communicate fluidly with the inlet lumen 402, allowing all of the body 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 dial 445 positions corresponding to additional seal outlet openings and / or flow controllers 440 can be included to further direct / isolate the fluid flow between the patient and the collection device 400. For example, the dial 445 may have a sixth position corresponding to a sixth embodiment of the flow controller 440, which substantially prevents fluid flow between the patient and the collection device 400 as a whole. In other words, in some embodiments, after all bodily fluid samples have been removed from the patient, the dial 445 may be moved to the sixth position to substantially seal the samples in the collection device 400 from the external environment.

[0071]

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

[0072]

[1125] In some embodiments, the housing 401 can selectively restrict the movement of the dial 445 from its first position to its second, third, fourth, and fifth positions. In some embodiments, the housing 401 can be configured to prevent the dial 445 from moving once it has reached the fifth position. In other words, the housing 401 may include a locking mechanism to prevent the dial 445 from moving back from the fifth position to the first position. The dial 445 and / or the housing 401 may also include mechanical stoppers and / or other indicators that provide visual or tactile feedback to ensure the precise positioning of the dial 445 relative to the exit openings 403a-403e of the wringing 401.

[0073]

[1126] During operation, the collection device 400 can be used to collect body 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., a flexible sterile tube). Following venipuncture (or other method of accessing body fluids), the dial 445 is driven (or turned) until it reaches a first position, as shown in Figures 19 and 20. Alternatively, the dial 445 can be pre-set to a 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 may 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 the dial 445 is in the first position, the flow controller 440 is in the first configuration, and the first opening 444a of the sealing member 441 establishes fluid communication between the inlet port 421 (included in the housing 401) and the first outlet port 430, while fluidly isolating the inlet port 421 from the four flow paths 435a to 335d. Furthermore, the sample reservoirs 480, 480', 490 and 490' are fluidly isolated from the inlet port 421 in the first configuration, and a fluid flow path is defined between a part of the patient's body (e.g., a vein) and the pre-sample reservoir 470, as indicated by the arrow GG in Figure 20. In this first configuration, body fluid flows from that part of the patient's body into the pre-sample reservoir 470 (e.g., by gravity, vacuum, etc.) through the inlet lumen 402 of the inlet port 421, the first opening 444a of the sealing member 441, and the first outlet port 430. In the first embodiment, the flow controller 440 also fluidly isolates the pre-sample reservoir 470 from the flow paths 435a-335d. Thus, a first volume (determined or undetermined) of body fluid can be received into the pre-sample reservoir 470 immediately after venipuncture and isolated from subsequent samples. In this way, the collection device 400 can be used to ensure that a first volume of body fluid, which is most likely to contain surface microorganisms and / or other undesirable external contaminants, does not contaminate subsequent volumes of body fluid samples collected and used for diagnostic or other tests that may be affected by contaminants.

[0075]

[1128] Following the collection of a body fluid presample into the presample reservoir 470, the dial 445 can be operated (rotated) until it reaches a second position, as shown in Figures 21 and 22. When the dial 445 is in the second position, the flow controller 440 is in a second configuration, and the second opening 444b of the sealing member 441 establishes fluid communication between the inlet port 421 and the flow path 435a, while fluidly isolating the presample reservoir 470 from the inlet port 421. In other words, in the second configuration, as indicated by the arrow HH in Figure 22, the flow controller 440 establishes a fluid flow path between a part of the patient's body (e.g., a vein) and the flow path 435a. With the flow controller 440 in the second configuration, the sample reservoir 480 can be operated by the user from the first configuration to the second configuration (e.g., by pushing the perforating member 455a) to establish fluid communication between a part of the patient's body (e.g., a vein) and the first sample reservoir 480.

[0076]

[1129] As described above, by moving the sample reservoir 480 to the second configuration, the perforating member 455a is positioned inside the sample reservoir 480, puncturing the vacuum seal of the sample reservoir 480. In this second configuration, a part of the patient's body (e.g., a vein) is subjected to a vacuum suction force from the sample reservoir 480 due to the negative pressure (vacuum) inside the sample reservoir 480. The pressure difference between the sample reservoir 480 (e.g., vacuum or negative pressure) and that part of the patient's body draws bodily fluids into the sample reservoir 480. The bodily fluids flow from that part of the patient's body into the first flow path 435a through the inlet lumen 402 of the inlet port 421, the second opening 444b of the sealing member 441, and the second outlet opening 403b of the housing 401. Vacuum suction draws the bodily fluid flow through the first channel 435a into the sample reservoir 480 via the second outlet port 431 and the perforating member 455a. In other words, in the second embodiment, the flow controller 440 establishes a fluid flow path between the inlet port 421 and the sample reservoir 480. Once a desired amount of bodily fluid (e.g., a second amount) has been collected in the sample reservoir 480, the user can isolate the first sample reservoir 480 from the channel 435a by operating (rotating) the flow controller 440 to a third position and / or moving the sample reservoir 480 back to its first embodiment. When the sample reservoir 480 returns to its first embodiment, the perforating member 455a is removed from the sample reservoir 480, and the seal of the sample reservoir 480 (e.g., a self-sealing membrane) isolates the first sample reservoir 480 from the channel 435a. The other sample reservoirs are filled in the same manner, with the flow controller 440 positioned in the third, fourth, and fifth configurations, respectively.

[0077]

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

[0078]

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

[0079]

[1132] The collection device 500 includes a flow distribution mechanism 520, a flow controller 540, a first sample reservoir 580, and a second sample reservoir 590. Sample reservoirs 580 and 590 may be substantially similar to the sample reservoirs described in detail above. In some embodiments, sample reservoirs 580 and 590 may have substantially the same shape and size and may contain substantially the same culture medium. In other embodiments, sample reservoirs 580 and 590 may have substantially the same shape and size and may contain either aerobic or anaerobic culture medium. In yet another embodiment, the first sample reservoir 580 may have a first size substantially larger than the size of the second sample reservoir 590.

[0080]

[1133] As shown in Figures 24 and 25, the flow diversion mechanism 520 includes a housing 501 and a distribution member 529. The housing 501 of the flow diversion mechanism 520 is physically and fluidly coupled to the distribution member 529 and provides and / or defines a set of fluid flow paths for collecting bodily fluids from a patient. As described above with respect to the housing 401, the housing 501 may define a recess and a first outlet opening 503a, a second outlet opening 503b, and a third outlet opening 503c. The recess is configured to receive a sealing member 541 included in the flow controller 540, as described in detail above. The first outlet opening 503a, the second outlet opening 503b, and the third outlet opening 503c may be substantially similar in form and function to the first outlet opening 403a, the second outlet opening 403b, and the third outlet opening 403c defined by the housing 401, respectively. Similarly, the distribution member 529 defines a presample reservoir 470, a first channel 435a, and a second channel 435b, which are substantially the same as those included in the flow division member 429. Accordingly, as described above with respect to the flow division mechanism 420, the presample reservoir 570 is in fluid communication with the first outlet opening 503a, the first channel 535a is in fluid communication with the second outlet opening 503b, and the second channel 535b is in fluid communication with the third outlet opening 503c. As shown in Figure 25, the distribution member 529 defines a first outlet port 531 that is in fluid communication with the first channel 535a and the first perforation member 555a, and a second outlet port 532 that is in fluid communication with the second channel 535b and the second perforation member 555b. As described above, the perforating members 555a and 555b can be used to puncture the vacuum seals of the sample reservoirs 580 and 590, as will be described in more detail herein, thereby initiating the flow of bodily fluids.

[0081]

[1134] The flow controller 540 includes a dial 545 and a sealing member 541. The sealing member 541 is positioned in a recess of the housing 501, as described above. Thus, when the flow controller 540 is coupled to the housing 501, the sealing member 541 forms a substantial fluid seal with the surface of the dial 545 and the surface of the housing 501 defining the recess. As shown in Figures 24 and 25, the sealing member 541 defines a first opening 544a, a second opening 503b, and a third opening 544c, which are substantially aligned with the first outlet opening 503a, a second outlet opening 503b, and a third outlet opening 503c, respectively, as described in detail above with respect to the sealing 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 having a size suitable for coupling with the housing 501. Thus, the dial 545 can be rotatably coupled to the housing 501 and movable between first, second, and third positions relative to the housing 501. The dial 545 includes an inlet port 521 defining a lumen 502, and the inlet port 521 can be fluidly coupled to a medical device (not shown) that defines a fluid flow path for extracting body fluids from a patient and / or transporting them to a collection device 500. In this way, the inlet port 521 can be configured to selectively position a pre-sample reservoir 570, a first sample reservoir 580, and a second sample reservoir 590. More specifically, when the dial 545 is in the first position, the flow controller 540 is in a first configuration, and the inlet port 521 is substantially aligned with the first opening 544a of the sealing member 541 and the first outlet opening 503a of the housing 501. Thus, as described in detail above with respect to the collection device 400, the first opening 544a of the sealing member 541 establishes fluid communication between the inlet port 521 and the first outlet opening 503a, thereby positioning the inlet port 521 to fluidly communicate with the presample reservoir 570. Similarly, when the dial 545 is turned (or driven) to the second position, the flow controller 540 is positioned in a second configuration, with the second outlet opening 544b establishing fluid communication between the inlet port 521 and the second outlet opening 503b, and thus the first flow path 535a. When the dial 545 is turned to the third position, the flow controller 540 is positioned in a third configuration, with the third outlet opening 544c establishing fluid communication between the inlet port 521 and the third outlet opening 503c, and thus the second flow path 535a. Thus, as described in detail above with respect to the collection device 400, the collection device 500 can be used to transfer a first volume of body fluid to the presample 570, and then to transfer a second and third volume of body fluid to the first sample reservoir 580 and the second sample reservoir 590, respectively.

[0083]

[1136] Figures 26 to 33 show the collection device 600 according to an embodiment. The collection device 600 includes a flow divider 620, a flow controller 640, and sample reservoirs 680, 680', 690, and 690'. As further described herein, the collection device 600 can be moved between the first, second, third, fourth, and fifth embodiments to deliver a stream of bodily fluids substantially free of extracorporeal microorganisms, such as microorganisms present on the skin and / or other undesirable external contaminants. The collection device 600 can be any preferred shape, size, or configuration. For example, embodiments and / or parts of the collection device 600 may be similar in form and / or function to any corresponding embodiments and / or parts of any of the collection devices 100, 200, 300, 400, and / or 500 described above. Accordingly, such similar embodiments and / or parts are not described in further detail herein. For example, in some embodiments, the sample reservoirs 680, 680', 690, and 690' of the collection device 600 may be substantially similar in form and / or function to and / or the sample reservoirs 480, 480', 490, and 490' included in the collection device 400 in Figures 16 to 22.

[0084]

[1137] The flow diversion mechanism 620 includes a distribution member 629 and a set of coupling members 637a, 637b, 637c, and 637d (see, for example, Figure 27). The distribution member 629 is in fluid communication with the coupling members 637a, 637b, 637c, and 637d and is configured to provide and / or define a set of fluid flow paths for collecting bodily fluids from the patient. As shown in Figures 27 and 28, the distribution member 629 defines and / or forms a first outlet port 630 in fluid communication with the presample reservoir 670, a second outlet port 631 in fluid communication with the first coupling member 637a, a third outlet port 632 in fluid communication with the second coupling portion 637b, a fourth outlet port 633 in fluid communication with the third coupling portion 637c, and a fifth outlet port 634 in fluid communication with the fourth coupling portion 637d.

[0085]

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

[0086]

[1139] As shown in Figure 29, the first coupling member 637a defines a flow path 638a which is fluidly coupled to the perforating member 655a. As described above, the coupling member 637a can be physically and fluidly coupled to the distributing member 629. For example, the flow path 638a can accept a portion of the second outlet port 631 of the distributing member, thereby physically and fluidly coupling the coupling member 637a to it. In some embodiments, the surface of the second outlet port 631 can form a substantially fluid-seal seal (e.g., a friction fit that can form a substantially airtight seal) with the inner surface of the coupling portion 637a defining the flow path 638a. The perforating member 655a of the coupling portion 637a may be substantially similar in form and function to the perforating member 455a included in the collection device 400 of Figures 16 to 22. Therefore, the perforating member 655a is not described further in this specification. The second coupling member 637b, the third coupling member 637c, and the fourth coupling member 637d are similarly arranged. Accordingly, the second coupling member 637b, the third coupling member 637c, and the fourth coupling member 637d each include perforating members 655b, 655c, and 655d, respectively, and define flow paths 638b, 638c, and 638d, respectively. As will be described in more detail herein, the flow diversion mechanism 620 can be selectively arranged using the first coupling member 637a, the second coupling member 637b, the third coupling member 637c, and the fourth coupling member 637d to provide fluid communication with the first sample reservoir 680, the second sample reservoir 680', the third sample reservoir 690, and the fourth sample reservoir 690', respectively.

[0087]

[1140] As shown in Figures 30 and 31, the flow controller 640 includes a dial 645 and a sealing member 641. The dial 645 of the flow controller 640 is rotatably positioned within the distribution member 629 (see Figures 32 and 33) and is movable between a first, second, third, and 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 in fluid communication with an internal space 646 (see, for example, Figure 30). The internal space 646 is configured to receive a portion of the sealing member 641, as will be described in more detail herein. The inlet port 621 can be fluidically coupled to a medical device (not shown) that defines a fluid flow path for extracting body fluids from a patient and / or transporting them to a collection device 600. For example, the inlet port 621 can be fluidically coupled directly or indirectly via an adapter 604 (see, for example, Figures 26 and 27) to a needle or other lumen defining device (e.g., a flexible sterile tube). The first outlet port 647 is in fluid communication with the pre-sample reservoir 670. For example, the first outlet port 647 can be rotatably positioned within the first outlet port 630 of the distribution member 629. When the dial 645 is in its first, second, third, and fourth positions, the second outlet port 648 can be selectively positioned to be in fluid communication with the second outlet port 631, the third outlet port 632, the fourth outlet port 633, and the fifth outlet port 634. Thus, as will be described in more detail herein, the internal space 646 of the dial 645 can be selectively positioned to be in fluid communication with 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'.

[0088]

[1141] At least a portion of the sealing member 641 of the flow controller 640 is rotatably positioned within the internal space 646 of the dial 645 and is movable between a first position and a second position. Furthermore, the sealing member 641 may have a size and shape such that its outer surface forms a substantially fluid-sealed seal with the inner surface of the dial 645, which defines at least a portion of the internal space 646. As shown in Figure 31, the sealing member 641 defines a first flow path 642 and a second flow path 644. When the sealing member 641 is in its first position within the internal space 646, the flow path 642 establishes fluid communication between the inlet port 621 and the first outlet port 647, while fluidly isolating the inlet port 621 from the second outlet port 648. Similarly, when the sealing member 641 is in its second position within the internal 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 as the dial 645 rotates to the second, third, and fourth positions within the distribution member 629. Therefore, if the inlet port 621 is positioned to communicate fluidly with the patient (for example, via a medical device coupled to the inlet port 621 and / or adapter 604), the first outlet port 630, second outlet port 631, third outlet port 632, fourth outlet port 633 and fifth outlet port 634 of the distribution member 629 can be selectively positioned to communicate fluidly with the inlet port 621, allowing body fluids to flow into the pre-sample reservoir 670, first sample reservoir 680, second sample reservoir 680', third sample reservoir 690 and fourth sample reservoir 690', respectively.

[0089]

[1142] During operation, the collection device 600 can be used to collect body 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 fluidically coupled to a needle or other lumen-defining device (e.g., a flexible sterile tube). Following venipuncture (or other method of accessing body fluids), the sealing member can be actuated (or rotated) until it reaches its first position, as shown in Figure 32. Alternatively, the sealing member 641 can be pre-set to the first position, and the collection device 600 can be sealed in other ways to maintain the sterility of the collection device 600. When the sealing 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. Accordingly, as indicated by arrow II in Figure 32, body fluids can be transferred from the patient into the presample reservoir 670 via the inlet port 621, the first channel 642, the first outlet port 647 of the dial 645, and the first outlet port 630 of the distribution member 629, in the same manner as described above with respect to the collection device 400.

[0090]

[1143] Following the collection of a body fluid presample in the presample reservoir 670, the sealing member 641 can be actuated (rotated) from its first position to its second position relative to the dial 645. Similarly, as shown in Figure 33, the dial 645 can be actuated (or rotated) until it reaches its second position relative to the distribution member 629. When the sealing member 641 and the dial 645 are in their second positions, the flow controller 640 is in its second configuration, and the second flow path 644 of the sealing member 641 establishes fluid communication between the inlet port 621 and the flow path 638a of the first coupling member 637a, while fluidly isolating the presample reservoir 670 from the inlet port 621. With the flow controller 640 in its second configuration, the sample reservoir 680 can be actuated by the user from its first configuration to its second configuration (for example, by pressing the puncturing member 655a) to establish fluid communication between a part of the patient's body (e.g., a vein) and the first sample reservoir 680. As described in detail above, by moving the sample reservoir 680 to the second configuration, the perforating member 655a is positioned inside the sample reservoir 680, puncturing the vacuum seal of the sample reservoir 680. In this second configuration, that part of the patient's body (e.g., a vein) is subjected to a vacuum suction force from the sample reservoir 680 due to the negative pressure (vacuum) inside the sample reservoir 680. Thus, as indicated by the arrow JJ in Figure 33, bodily fluids can be forced to flow from that part of the patient's body into the first sample reservoir 680 through the inlet port 621, the second flow path 644, the second outlet port 631 and flow path 638a, and the perforating member 655a of the first coupling member 637a.

[0091]

[1144] Once a desired volume (e.g., a second volume) of body fluid has been collected in the sample reservoir 680, the user can isolate the first sample reservoir 680 from the second flow channel 644 by operating (rotating) the flow controller 640 to the third position and / or moving the sample reservoir 680 back to its first configuration. When the sample reservoir 680 returns to its first configuration, the perforating member 655a is removed from the sample reservoir 680, and the seal (e.g., a self-sealing membrane) of the sample reservoir 680 fluidly isolates the first sample reservoir 680 from the flow channel 635a. Filling of the other sample reservoirs is carried out similarly with the flow controller 640 positioned in the third, fourth, and fifth configurations, respectively.

[0092]

[1145] Figures 34 to 40 show the collection device 700 according to an embodiment. The collection device 700 includes a flow divider 720, a flow controller 740, and sample reservoirs 780 and 790 (holders exist for four sample reservoirs, but for clarity only two are shown in the figures; additional sample reservoirs (e.g., fifth, sixth, etc.) may be included as part of the collection device 700). As further described herein, the collection device 700 can be moved between the first, second, third, fourth, and fifth embodiments to deliver a stream of body fluids 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 any preferred shape, size, or configuration. For example, embodiments and / or parts of the collection device 700 may be substantially similar in form and / or function to the corresponding embodiments and / or parts of any of the collection devices 100, 200, 300, 400, 500, and / or 600 described above. Accordingly, such similar embodiments and / or parts will not be described in further detail herein. For example, in some embodiments, the sample reservoirs 780 and 790 of the collection device 700 may be substantially similar in form and function to the sample reservoirs 480 and 490, respectively, included in the collection device 400 of Figures 16 to 22.

[0093]

[1146] The flow diversion mechanism 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 703a, a second outlet opening 703b, a third outlet opening 703c, a fourth outlet opening 703d, and a fifth outlet opening 703e, each configured to be in fluid communication with different parts of the distribution member 729. More specifically, the distribution member 729 defines and / or forms at least a portion of the presample reservoir 770 in fluid communication with the first outlet opening 703a, a first fluid chamber 735a in fluid communication with the second outlet opening 703b, a second fluid chamber 735b in fluid communication with the third outlet opening 703b, a third fluid chamber 735c in fluid communication with the fourth outlet opening 703d, and a fourth fluid chamber 735d in fluid communication with the fifth outlet opening 703e. Furthermore, as further described herein, the housing 701 defines a recess 766 configured to movably receive at least a portion of the flow controller 740.

[0094]

[1147] As shown in Figure 36, the distribution member 729 defines a chamber or space that forms at least a portion of the presample reservoir 770. The presample reservoir 770 is configured to contain, for example, body fluids 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 presample reservoir 770 so that the presample reservoir 770 can receive a flow of body fluids from the patient, as described in detail above. Further detail, the distribution member 729 includes a pair of walls 736 that can divide the internal space of the distribution member 729 into portions and / or spaces that are fluidly isolated from each other. For example, as shown in Figure 36, the pair of walls 736 can divide the internal space of the distribution member 729 into the presample 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, the wall 736 may equally define and / or form the presample reservoir 770 and the fluid chambers 735a-735d. In other embodiments, the presample reservoir 770 may define a space different from the space defined by the fluid chambers 735a-735d.

[0095]

[1148] The distribution member 729 further includes a first perforating member 755a, a second perforating member 755b, a third perforating member 755c, and a fourth perforating member 755d, which are in fluid communication with the first fluid chamber 735a, the second fluid chamber 735b, the third fluid chamber 735c, and the fourth fluid chamber 735d, respectively. Thus, the perforating members 755a to 355d can be used to puncture the sample reservoirs 780 and 790 (and corresponding sample reservoirs not shown in Figures 34 to 40), as described in more detail herein, thereby initiating the flow of bodily fluids.

[0096]

[1149] The flow controller 740 of the collection device 700 includes a dial 745 and a sealing member 741. The sealing member 741 is positioned within a recess 766 of the housing 701 (see, for example, Figures 38 and 40). More specifically, the flow controller 740 can be coupled to the housing 701 such that the sealing member 741 is positioned between and in contact with the surface of the housing 701 defining the recess 766 and the surface of the dial 745. The sealing member 741 can be configured to form a substantially fluid-sealed seal with the surface of the dial 745 and the surface of the housing 701 defining the recess 766, as described in detail above. As shown in Figure 35, the sealing member 741 defines a first opening 744a, a second opening 744b, a third opening 744c, a fourth opening 744d, and a fifth opening 744e. The arrangement of the sealing member 741 is such that when the sealing member 741 is placed in 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] The dial 745 of the flow controller 740 is rotatably coupled to the housing 701 and is movable between first, second, third, fourth, and fifth positions relative to the housing 701. The dial 745 includes an inlet port 721, which can be fluidically coupled (directly or indirectly via an adapter 704) to a medical device that defines a fluid flow path for withdrawing bodily fluids from a patient and / or transporting them to a collection device 700. Thus, the inlet port 721 can be configured to selectively position the pre-sample reservoir 770, first sample reservoir 780, second sample reservoir 780', third sample reservoir 790, and fourth sample reservoir 790' to fluidize the patient, as described in further detail herein. When the dial 745 is in the first position, the flow controller 740 is positioned in the first configuration, allowing the inlet port 721 to be substantially aligned with the first opening 744a of the sealing member 741 and the first outlet opening 703a of the housing 701. In this way, the first opening 744a of the sealing member 741 fluidly isolates the inlet port 721 from the outlet openings 703b, 703c, 703d, and 703e, thereby fluidly isolating the inlet port 721 from the fluid chambers 735a to 335d while establishing fluid communication between the inlet port 721 and the first outlet opening 703a. When the dial 745 is turned (or driven) to the second position, the flow controller 740 is positioned in the 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 presample reservoir 770 and fluid chambers 735b-735d. The collection device 700 operates similarly when the dial 745 is turned to the third, fourth, and fifth positions.Therefore, when the inlet port 721 is configured to communicate fluidly with the patient (for example, 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 configured to communicate fluidly with the inlet port 721 so that all of the body fluids 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, the housing 701 can selectively restrict the movement of the dial 745 from its first position to its second, third, fourth, and fifth positions. In some other embodiments, the housing 701 can be configured to prevent the dial from moving once it has reached the fifth position. In other words, the housing 701 may include a locking mechanism that prevents the dial 745 from moving from the fifth position back to the first position. This feature reduces the risk of contamination of bodily fluids collected in the flow chambers 735a-735d and / or sample reservoirs 780 and 790 from bodily fluids contained in the pre-sample reservoir 770 (which are at high risk of containing surface-bound microorganisms and / or other undesirable external contaminants). This locking mechanism can also protect healthcare workers from exposure to bloodborne pathogens in patient samples that may include HIV, hepatitis C, etc. The dial 745 and / or housing 701 may also include mechanical stoppers and / or other indicators that provide visual or tactile feedback to ensure the precise alignment of the dial 745 with respect to the outlet port 703a and outlet openings 703a-703d in the housing 701.

[0099]

[1152] Similar to the embodiment of the collection device 400 shown in Figures 16 to 22, the collection device 700 includes a presample reservoir 770, which is a chamber housed within a distribution member 729. The presample reservoir 770 can contain bodily fluids such as blood, plasma, or urine. The presample reservoir 770 is configured to be fluidically coupled to a first outlet port 703a of the collection device 700 (located within the housing 701). During operation of the collection device 700, when the flow controller 740 is in the first position, bodily fluids are drawn from a part of the patient's body (e.g., a vein) through the inlet port 721 into the presample reservoir 770, the opening for the presample reservoir 744a located within the sealing member 741, and the first outlet port 703a. The presample reservoir 770 is configured to contain a first volume of fluid to be withdrawn from the patient, where the first volume of body fluid can be a predetermined amount or undetermined, thereby fluidically separating the first volume of body fluid from the second and / or third and / or fourth and / or fifth volumes of body fluid to be subsequently withdrawn from the patient.

[0100]

[1153] During operation, the collection device 700 can be used to collect body 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., a flexible sterile tube). Following venipuncture, the dial 745 is turned until it reaches the first position, as shown in Figures 37 and 38. Alternatively, as described above, the dial 745 can be pre-set to the first position, and the collection device 700 can be sealed in other ways to maintain the sterility of the collection device 700. With the dial 745 in the first position, the flow controller 740 is positioned in the first embodiment, and the first outlet opening 744a of the sealing member 741 establishes fluid communication between the inlet port 721 (included in the housing 701) and the first outlet port 741, while fluidly isolating the inlet port 721 from the four sample flow paths 735a-735d. In this first embodiment, body fluid flows from that part of the patient's body through the inlet port 721, the first outlet opening 744a of the sealing member 741, and the first outlet port 703a of the housing 701 into the pre-sample reservoir 770 defined by the dispensing member 770, as indicated by arrow KK in Figure 38. Thus, as described in detail above, a first volume (determined or undetermined) of body fluid can be received into the pre-sample reservoir 770 immediately after venipuncture and isolated from subsequent samples.

[0101]

[1154] Following the collection of a bodily fluid presample in the presample reservoir 770, the dial 745 can be operated (or rotated) until it reaches the second position, as shown in Figures 39 and 40. When the dial 745 is in the second position, the flow controller 740 is in the second configuration, and the second outlet opening 744a of the sealing member 741 establishes fluid communication between the inlet port 721 and the first fluid chamber 735a, while fluidly isolating the presample reservoir 770 from the inlet port 721. Once the first fluid chamber 735a is filled with bodily fluid, the flow controller 740 can be moved to the third position to isolate and seal the first flow path 735a from the external environment. Furthermore, the sample reservoir 780 can be operated from the first configuration to the second configuration to transfer the bodily fluid from the first fluid chamber 735a to the sample reservoir 780. For example, the sample reservoir 780 can be operated by a user or automatically from the first to the second form (by pushing the perforating member 755a) to establish fluid communication between a part 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 form, the perforating member 755a punctures the vacuum seal of the sample reservoir 780 and is positioned inside the sample reservoir 780. In the second form, that part of the patient's body (e.g., a vein) is subjected to vacuum aspiration from the sample reservoir 780 by the negative pressure (vacuum) present inside the sample reservoir 780 in some embodiments. Thus, as indicated by arrow LL in Figure 40, the body fluid flows from that part of the patient's body into the first sample reservoir 780 through the inlet port 721, the second outlet opening 744b of the sealing member 741, the second outlet opening 703b of the housing 701, and the second fluid chamber 735b.

[0102]

[1155] Once a desired amount (e.g., a second amount) of body fluid has been collected in the sample reservoir 780, the user can isolate the first sample reservoir 780 from the inlet port 721 by operating (rotating) the flow controller 740 to the third position and / or moving the sample reservoir 780 back to its first configuration. When the sample reservoir 780 returns to its first configuration, the perforating member 755a is removed from the sample reservoir 780, and the seal (e.g., a self-sealing membrane) of the sample reservoir 780 fluidically isolates the first sample reservoir 780 from the second fluid chamber 735b and the external environment. Filling of the other sample reservoirs is performed in the same manner when the flow controller 740 is in the third, fourth, and fifth configurations, respectively.

[0103]

[1156] In some embodiments, the collection device 700 can be configured such that there is no set of walls 736 separating the different fluid chambers 735a-735d within the dispensing member 729 (see the detailed cross-sectional view in Figure 16). In such embodiments, the dispensing member 729 is divided between the fluid chambers 735 coupled to the pre-sample reservoir 770 (i.e., the fluid chambers are not separated into four distinct parts by walls 736). In such embodiments, the user can fill all four sample reservoirs at once by operating (rotating) the dial 745 to any of the second, third, fourth, or fifth positions.

[0104]

[1157] Any of the embodiments described herein can be used with a weighing device that can be used, for example, to measure (e.g., quantify) the flow of body fluid into the pre-sample reservoir and / or sample reservoir. In some cases, due to the fact that the filling volume is visually determined by the clinician and / or phlebotomist and is therefore susceptible to human error, consistent compliance with the accurate inoculation volume of body fluid (e.g., blood sample) cannot be ensured by the implementation of the test standard. The fact that the volume indicator on the blood collection bottle is difficult to read when held and that the collection bottle is not held upright during the withdrawal procedure can contribute to inaccurate volume of body fluid samples received from patients. Insufficient sample volume (e.g., below the manufacturer's recommendation) can reduce the sensitivity of the culture test and lead to false negative results. Furthermore, filling volumes exceeding the manufacturer's recommendation, as indicated in the summary materials and instructions for use for certain types of test supplies and devices (e.g., blood culture bottles designed for use with automated microbial detection systems produced by manufacturers such as Franklin Lakes, NJ, and Becton Dickinson), can result in false positives. Therefore, the flow metering and volume display functions allow laboratory technicians and / or healthcare professionals (e.g., phlebotomists) to verify the volume of bodily fluids collected in each individual sample reservoir before placing the sample reservoir in an incubator or other laboratory equipment, depending on how the sample needs to be processed. Laboratory technicians and / or phlebotomists can also record accurate volume information (e.g., in medical records, databases, spreadsheets, etc.) for clinicians to evaluate when the results are received, thereby helping to reduce the possibility of misinterpretation of false negative and / or false positive results.

[0105]

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

[0106]

[1159] As shown in Figures 41 to 43, the flow diversion 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 diversion mechanism 820 is substantially cylindrical and includes a set of actuator walls defining an internal space 806. More specifically, the actuator portion 822 includes a substantially closed first end and a second end opposite the first end, which is substantially open to allow access to the internal space 806. Thus, the actuator portion 822 can movably receive at least a portion of the flow controller 840, as will be described in more detail herein. The actuator portion 822 further includes an inlet port 821 and an outlet port 831. The inlet port 821 can be fluidically coupled (directly or indirectly via an adapter 804) to a medical device that defines a fluid flow path for extracting bodily fluids from a patient and / or transporting them to a collection device 800, as will be described in detail above.

[0107]

[1160] The outlet port 831 of the actuator portion 822 can be selectively positioned to fluidly communicate a portion of the internal space 806 of the actuator portion 822 with the internal space 807 defined by the intermediate portion 823. As shown in Figure 43, the intermediate portion 823 is positioned between the actuator portion 822 and the coupling portion 824. Although not shown in Figures 41 to 45, the intermediate portion 823 may include a metering device that can be configured to measure, for example, the volume of bodily fluid being transferred to the sample reservoir 880. For example, in some embodiments, a flow metering device can be fluidly coupled to the outlet port 831 to measure the flow of bodily fluid passing through it. As shown in Figures 41 and 42, the intermediate portion 823 includes a display 875, which can provide the user with, for example, a visual indicator and / or information relating to the volume of bodily fluid flowing through the outlet port 831. In other embodiments, the flow metering device can be positioned in or along any other suitable location within the flow diversion mechanism 820.

[0108]

[1161] The coupling portion 824 can be physically and fluidly coupled to the intermediate portion 823. For example, in some embodiments, the coupling portion 824 can be partially positioned within the internal space 807 of the intermediate portion 823 and coupled to it at least temporarily via friction fitting, press fitting, snap fitting, screw coupling, adhesive, etc. The coupling portion 824 is configured to receive a portion of the sample reservoir 880, as described in detail above, and includes a perforating member 855 that can be used to puncture the vacuum seal of the sample reservoir 880, thereby initiating the flow of bodily fluids.

[0109]

[1162] The flow controller 840 of the collection device 800 is at least partially located within the internal space 806 defined by the actuator portion 822 and is movable between the first, second, and third embodiments. As shown in Figures 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). The seal members 861, 862, and 863 are in contact with the inner surface of the actuator portion 822 that defines the internal space 806. Thus, as will be described in more detail herein, the seal members 861, 862, and 863 can each form a substantially fluid-sealed seal with an inner surface that can, for example, divide the internal space 806 of the actuator portion 822 into fluidly isolated portions.

[0110]

[1163] The movable member 850 is movable between a first position, a second position and a third position within the internal space 806. The arrangement of the movable member 850 may be such that, as the movable member 850 moves between its first, second, and third positions, the sealing members 861, 862, and 863 move selectively within the internal space 806. More specifically, as the movable member 850 moves between its first, second, and third positions, the first sealing member 861 can be moved simultaneously with the movable member 850. The second sealing member 862 and the third sealing member 863 can be fixedly coupled to each other (for example, positioned at a fixed distance from each other) and slidably arranged around a portion of the movable member 850, thereby enabling the movable member 850 to move from its first position (see, for example, Figure 43) to its second position (see, for example, Figure 44) while the second sealing member 862 and the third sealing member 863 remain in substantially fixed positions relative to the actuator portion 822. For example, when the movable member 850 moves between its first and second positions, the second sealing member 862 and the third sealing member 863 can remain in substantially fixed positions, thereby positioning the inlet port 821 on the first side of the second sealing member 862 and the outlet port 831 on the second side opposite to the first side of the second sealing member 862. Thus, as will be described in more detail herein, when the movable member 850 is in its first position (Figure 43) and second position (Figure 44), the inlet port 821 is in fluid communication with the portion of the internal space 806 defined between the first sealing member 861 and the second sealing member 862, and the outlet port is in fluid communication with the portion of the internal space 806 defined between the second sealing member 862 and the third sealing member 863.

[0111]

[1164] The flow controller 840 may be configured such that when the movable member 850 moves from its first position to its second position, the first seal member 861 moves relative to the second seal member 862 and the third seal member 863. The movement of the first seal member 861 relative to the second seal member 862 allows the space defined between them to expand, thereby forming and / or defining a presample reservoir 870. Furthermore, because the seal members 861 and 862 form a substantial fluid seal with the inner surface of the actuator portion 822, the presample reservoir 870 defined between the first seal member 861 and the second seal member 862 is fluidically isolated from the rest of the internal space 806. Thus, when the movable member 850 moves from its first position to its second position, the inlet port 821 can communicate fluidly with the presample reservoir 870. As the movable member 850 moves from its second position (see, for example, Figure 44) to its third position (see, for example, Figure 45), a portion of the movable member 850 comes into contact with the third seal member 863, allowing the first seal member 861, the second seal member 862, and the third seal member 863 to move substantially simultaneously within the internal space 806. Thus, as will be described in further detail herein, the second seal member 862 can be moved relative to the inlet port 821 so that both the inlet port 821 and the outlet port 831 are in fluid communication with the portion of the internal space 806 defined between the second seal member 862 and the third seal member 863.

[0112]

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

[0113]

[1166] Following the collection of the volume of the bodily fluid presample in the presample reservoir 870, the movable member 850 can be moved from its second position to its third position, as shown by the arrow OO in Figure 45, to position the flow controller in a third configuration. As described above, when the movable member 850 moves from its second position to its third position, a portion of the movable member 850 is positioned to contact the third seal member 863. Thus, the movable member 850 moves the first seal member 861, the second seal member 862, and the third seal member 863 substantially simultaneously within the internal space 806. Consequently, the second seal member 862 can be moved relative to the inlet port 821 so that both the inlet port 821 and the outlet port 831 are in fluid communication with the portion of the internal space 806 defined between the second seal member 862 and the third seal member 863. Furthermore, because the volume of the body fluid is fluidically isolated within the presample reservoir 870, the movement of the second seal member 862 and the third seal member 863 in the direction of the first seal member 861 is restricted (i.e., the body fluid is substantially an incompressible fluid). Thus, the presample volume of the body fluid is sequestered within the presample reservoir 870, and the space defined between the second seal member 862 and the third seal member 863 defines a fluid flow path between the inlet port 821 and the outlet port 831. In addition, the arrangement of the flow controller 840, when in its third configuration, is such that the first seal member 861 is in contact with the biasing member 859, and at least a portion of the force applied by the user to the movable member 850 is operable to deform, compress, bend and / or reconfigure the biasing member 859. Accordingly, the biasing member 859 can exert a reaction force on the first sealing member 861 that resists the movement of the flow controller 840 from its second form to its third form, as will be 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 perforating member 855 is positioned inside the sample reservoir by perforating the vacuum seal of the sample reservoir 880. The pressure difference between the sample reservoir 880 (e.g., vacuum or negative pressure) and that part of the body draws the body fluid into the sample reservoir 880. In other words, in the second embodiment, the flow controller 840 and the flow diversion mechanism 820 establish a fluid path so that the body fluid can be drawn from the patient into the sample reservoir 880 through the inlet port 821, the portion of the internal space 806 defined between the second seal member 862 and the third seal member 863, and the outlet port 831 of the actuator portion 822, through the perforating member 855 of the intermediate portion 823 and the coupling portion 824, as shown by arrow PP in Figure 45. As described above, a weighing device (not shown) can measure the volume of bodily fluids being transported, for example, through the outlet port 831, and display a value related to the volume of bodily fluids on the display 875.

[0115]

[1168] Once a desired volume (e.g., a second volume) of bodily fluid has been collected in the sample reservoir 880, the user can remove and / or reduce the force applied to the movable member 850, thereby allowing the biasing member 859 to move the first seal member 861 and the movable member 850 from their third position to their second position. Furthermore, because the bodily fluid placed in the pre-sample reservoir 870 is substantially incompressible, the movement of the first seal member 861 transfers force through the volume of bodily fluid, moving the second seal member 862 and the third seal member 863 from their third position to their second position. In some embodiments, the biasing member 859 can apply a force to the first seal member 861 that may be capable of moving the second seal member 862 to a fourth position, for example, which can substantially block the inlet port 821 from the actuator portion 822. Thus, the inlet port 821 can be fluidly isolated from the internal space 806 of the actuator portion 822. Furthermore, the perforating member 855 can be removed from the sample reservoir 880, and the seal (e.g., a self-sealing membrane) can fluidly isolate the body fluid sample from the space outside the sample reservoir 880. Subsequent filling of the sample reservoir can be performed similarly by placing the perforating member 855 inside the sample reservoir and moving the flow controller 840 to the third configuration to allow the body fluid to flow from the patient into the sample reservoir.

[0116]

[1169] Figures 46 to 53 show the collection device 900 according to an embodiment. The collection device 900 includes a flow diversion mechanism 920, a flow controller 940, and sample reservoirs 980, 980', 990, and 990'. As further described herein, the collection device 900 can be moved between the first, second, third, fourth, and fifth embodiments to deliver a stream of bodily fluids 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 any preferred shape, size, or configuration. For example, embodiments and / or parts of the collection device 900 may be substantially similar in form and / or function to any corresponding embodiments and / or parts of any of the collection devices 100, 200, 300, 400, 500, 600, 700, and / or 800 described above. Therefore, such similar embodiments and / or parts are not described in further detail herein. For example, in some embodiments, the sample reservoirs 980, 980', 990, and 990' of the collection device 900 may be substantially similar in form and function to and / or identical to the sample reservoirs 680, 680', 690, and 690' included in the collection device 600 in Figures 26 to 33.

[0117]

[1170] The flow distribution mechanism 920 includes a housing 901, a distribution member 929, and movable members 950a, 950b, 950c, and 950d. The housing 901 is physically and fluidly coupled to the distribution member 929 and provides and / or defines a set of fluid flow paths for collecting bodily fluids from a patient. The housing 901 includes a set of displays 975' (e.g., liquid crystal displays (LCDs), etc.) which can be included in and / or coupled in other ways (e.g., electrically and / or mechanically) to a flow metering device, as described in more detail herein. The housing 901 defines a recess 966, outlet openings 903a, 903b, 903c, 903d, 903e, and movable member openings 950a, 950b, 950c, and 950d (also referred to herein as “openings”). The recess 966 is configured to receive a sealing member 941 included in the flow controller 940, as described in more 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 different fluid passages that are in fluid communication with different parts of the distribution member 929. More specifically, the distribution member 929 defines and / or forms at least a portion of the presample reservoir 970 that is in fluid communication with the first outlet opening 903a, a first passage 935a that is in fluid communication with the second outlet opening 903b, a second passage 935b that is in fluid communication with the third outlet opening 903b, a third passage 935c that is in fluid communication with the fourth outlet opening 903d, and a fourth passage 935 that is in fluid communication with the fifth outlet opening 903e.

[0118]

[1171] As shown in Figures 47 and 48, the distribution member 929 defines a chamber or space that defines at least a portion of the presample reservoir 970. The presample reservoir 970 is configured to contain bodily fluids such as blood, plasma, or urine. As described in detail with respect to the presample reservoir 470 in Figures 16 to 22, the first outlet opening 903a of the housing 901 can be substantially aligned with the open portion of the presample reservoir 970 so that the presample reservoir 970 can receive a flow of bodily fluids from the patient. The flow paths 935a to 935d extend radially from the center of the distribution member 929, and each flow path 935a, 935b, 935c, and 935d is arranged to be fluidically isolated from the presample reservoir 970 and other flow paths. Thus, the fluid flow paths 935a, 935b, 935c, and 935d can be directed and / or otherwise defined 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. In Figures 47 and 48, the distribution member 929 is shown to include substantially closed flow paths 935a-935d, but in other embodiments, the flow paths 935a-935d can be substantially open, as shown and described above with respect to the distribution member 429 in Figures 17 and 18. Therefore, 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] The movable members 950a, 950b, 950c, and 950d are movably positioned to the openings 905a, 905b, 905c, and 905d of the housing 901, respectively, and to the corresponding openings defined by the second end of the distribution member 929. Although not shown in Figures 46 to 53, in some embodiments, the movable members 950a, 950b, 950c, and 950d can be operably coupled to biasing members, etc., as described in detail above with respect to the movable members 250 and 250' of the collection device 200. In this way, the user can operate (move) the movable members 950a, 950b, 950c, and 950d from first and second positions relative to the housing 901 and the distribution member 929 to direct the fluid flow into the first sample reservoir 980, the second fluid reservoir 980', the third fluid reservoir 990, and the fourth sample reservoir 990', respectively. The movable members 950a, 950b, 950c, and 950d are substantially the same and are therefore described in relation to a single movable member 950 in Figure 49. Furthermore, some parts of the movable member 950 may be substantially the same as the movable members 250 and 350 described above. Therefore, some parts of the movable member 950 will not be described in further detail herein. The movable member 950 defines an internal cavity 952 that is in fluid communication with an inlet port 953 and a perforating member 955. The perforating member is substantially the same as that described in detail above. The inlet port 953 extends through a pair of walls that define the internal chamber 952 of the movable member 950 so as to be selectively positioned to connect the internal space 952 of the movable member 950 to the corresponding flow paths 935a, 935b, 935c, or 935d.

[0120]

[1173] As shown in Figure 49, the movable member 950 includes a flow control mechanism 967 that is rotatably positioned within the internal space 952 and is substantially in 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 way, bodily fluid can enter the inlet port 953 of the movable member 950 and flow through the flow metering device 967, thereby allowing the flow metering device 967 to rotate relative to the movable member 950. Therefore, the rotational feature of the flow metering device 967 may be useful in determining the volume, volumetric flow rate, etc., of bodily fluid being transferred into the internal space 952 of the movable member 950. Although not shown in Figures 46 to 53, the flow control mechanism 967 of the movable member 950 is operably coupled to the display 975' of the housing 901. Therefore, when body fluids are transferred to, for example, sample reservoirs 980, 980', 990 and / or 990', volume information related to the flow of body fluids can be displayed on the display 975'. In this way, the user can operate the collection device 900 to collect a body fluid sample from a patient and visualize at least one of the displays 975' to determine, for example, the exact volume of the body fluid sample being transferred to the sample reservoir 980.

[0121]

[1174] The flow controller 940 of the collection device 900 includes a dial 945 and a sealing member 941. The sealing member 941 is located in a recess 966 of the housing 901. More specifically, the flow controller 940 can be coupled to the housing 901 such that the sealing member 941 is located between and in contact with the surface of the housing 901 defining the recess 966 and the surface of the dial 945. As described in detail herein, the sealing member 941 can be configured to form a substantially fluid-sealed seal with the surface of the dial 945 and the surface of the housing 901 defining the recess 966. As shown in Figure 47, the sealing member 941 defines a first opening 944a, a second opening 944b, a third opening 944c, a fourth opening 944d, and a fifth opening 944e. The arrangement of the sealing member 941 is such that when the sealing member 941 is placed in 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] The dial 945 of the flow controller 940 is rotatably coupled to the housing 901 and is movable between first, second, third, fourth, and fifth positions relative to the housing 901. The dial 945 includes an inlet port 921, which can be fluidically coupled (directly or indirectly via an adapter 904) to a medical device that defines a fluid flow path for withdrawing body fluids from a patient and / or transporting them to a collection device 900. Thus, the inlet port 921 can be configured to selectively position the pre-sample reservoir 970, first sample reservoir 980, second sample reservoir 980', third sample reservoir 990, and fourth sample reservoir 990' to fluidize the patient, as described in further detail herein. The dial 945 can be configured to rotate through a first, second, third, fourth, and fifth position in substantially the same manner as described above with respect to the dial 445 of the collection device 400, and therefore, this will not be described in further detail herein.

[0123]

[1176] As illustrated, the dial 945 may further include a display 975 which can be configured to display volume information related to the flow of bodily fluids. For example, although not shown in Figures 46 to 53, the dial may include a flow metering device such as a flow metering device 967 included in the movable member 950. Thus, the flow metering device can, for example, measure the flow of bodily fluids through the inlet port 921, and the display 975 can be operably coupled to the dial 945 so that volume information related to the flow of bodily fluids through the inlet port 921 is displayed on the display 975.

[0124]

[1177] During operation, the collection device 900 can be used to collect body 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., a flexible sterile tube). Following venipuncture (or other method of accessing body fluids), the dial 945 is driven (or turned) until it reaches the first position, as shown in Figures 50 and 51. Alternatively, the dial 945 can be pre-set 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 the dial 945 is in the first position, the flow controller 940 is in the first configuration, and the first opening 944a of the sealing member 941 establishes fluid communication between the inlet port 921 (included in the housing 901) and the first outlet port 930, while fluidly isolating the inlet port 921 from the four flow paths 935a to 335d. Furthermore, the sample reservoirs 980, 980', 990 and 990' are fluidly isolated from the inlet port 921 in the first configuration, and a fluid flow path is defined between a part of the patient's body (e.g., a vein) and the pre-sample reservoir 970, as indicated by the arrow QQ in Figure 51. In this first configuration, body fluid flows into the pre-sample reservoir 970 from that part of the patient's body (e.g., by gravity, vacuum, etc.) through the inlet port 921, the first opening 944a of the sealing member 941, and the first outlet port 903a of the housing 901. In the first embodiment, the flow controller 940 also fluidly isolates the pre-sample reservoir 970 from the flow paths 935a-935d. Thus, a first volume (determined or undetermined) of body fluid can be received into the pre-sample reservoir 970 immediately after venipuncture and isolated from subsequent samples. In this way, the collection device 900 can be used to ensure that a first volume of body fluid, which is most likely to contain surface microorganisms and / or other undesirable contaminants, does not contaminate subsequent volumes of body fluid samples collected and used for diagnostic or other tests that may be affected by contaminants. Furthermore, the display 975 can present information received from a flow control mechanism (not shown) relating, for example, the volume of body fluid being transferred to the pre-sample reservoir 970. Thus, the exact volume of body fluid can be transferred to the pre-sample reservoir and fluidly isolated therein.

[0126]

[1179] Following the collection of a body fluid presample in the presample reservoir 970, the dial 945 can be operated (or rotated) until it reaches the second position, as shown in Figures 52 and 53. When the dial 945 is in the second position, the flow controller 940 is in the second configuration, and the second opening 944b of the sealing member 941 establishes fluid communication between the inlet port 921 and the flow path 935a, while fluidly isolating the presample reservoir 970 from the inlet port 921. With the flow controller 940 in the second configuration, the user can operate the movable member 950a from the first position to the second position (i.e., by pressing it) to establish fluid communication between the patient (e.g., a vein) and the first sample reservoir 880. More specifically, as shown by the arrow RR in Figure 53, the movable member 950 moves from its first position to its second position so that the perforating member 955 passes through the vacuum seal of the first sample reservoir 980 and is positioned inside 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 fluids to flow from the first flow path 935a into the internal cavity 952 of the movable member 950, out of the perforating member 955, and into the first sample reservoir 980. The pressure difference between the sample reservoir 980 (e.g., vacuum or negative pressure) and the first flow path 935a draws the bodily fluids into the sample reservoir 980. In other words, in the second embodiment, as indicated by arrow SS in Figure 53, 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. Furthermore, the flow of bodily fluids through the movable member 950a causes the flow metering mechanism 967 to rotate relative to the movable member 950. Therefore, the rotation of the flow metering mechanism 967 may be used to determine the volume of the body fluid sample being transferred to the sample reservoir 980. Furthermore, the display 975' can display information received from the flow control mechanism 967, for example, relating to the volume of body fluid being transferred to the sample reservoir 980. Thus, the exact volume of body fluid can be transferred to the sample reservoir 980. For example, in some cases, the collection device 900 can 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 of 60 mL of sample volume is collected).

[0128]

[1181] Once a desired volume (e.g., a second volume) 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 perforating 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. Using the collection device 900, the second sample volume can be transferred to the second sample reservoir 980', the third sample volume to the third sample reservoir 990', and the fourth sample volume to the fourth sample reservoir 990', respectively, by rotating the dial 945 to its third, fourth, and fifth positions.

[0129]

[1182] In some cases, the fluid collection device 900 allows a clinician and / or phlebotomist to open the package containing the fluid collection device 900, remove only the housing 901 (including the dispensing member 929), and bring the housing 901 to the patient's bedside. The clinician and / or phlebotomist can perform venous puncture (or employ any other method to access the patient's fluids) into a part of the patient's body (e.g., a vein) using any standardized technique. Following venous puncture, the clinician and / or phlebotomist can collect the required total blood volume for all samples. For example, the clinician and / or phlebotomist can collect a 2.5 mL pre-sample dispensing volume and a 10 mL sample volume into each of the four sample reservoirs, thereby resulting in a total of 42.5 mL of collected fluid (e.g., blood). Following the collection of the desired volume of body fluid, the subcutaneous injection needle can be removed from that part of the patient's body (e.g., a vein), and the clinician and / or phlebotomist can place the housing 901 (containing the body fluid) on top of four (or two) packs of pre-sterilized sample reservoirs, with the membrane tops pre-positioned in a custom tray that conforms to the shape of the housing 901. By using these pre-sterilized packs of sample reservoirs, the clinician does not need to perform a process step of "wiping" the tops of the sample reservoirs with a sterilizing agent, thereby reducing the possibility of contamination, for example, if the sterilization of the reservoir tops is inadequate and / or insufficient. The clinician and / or phlebotomist can then initiate automated inoculation of the sample reservoirs containing body fluid with precise volume control. In some embodiments, after the inoculation of the sample reservoirs is complete, the entire device 900, which displays volume information for each individual sample reservoir, can be sent to the laboratory for analysis. In other embodiments, the sample reservoirs 980 and / or 990 can be individually removed and sent to a laboratory for analysis.

[0130]

[1183] The collection device 900 is shown and described with reference to Figures 46 to 53 as including a pair of displays 975 and 975' that can present volume data relating to the volume of bodily fluids transported 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, Figures 54 and 55 show a flow diversion mechanism 1020 and a flow controller 1040 according to an embodiment. The flow diversion mechanism 1020 and the flow controller 1040 may be substantially similar in form and function to the flow diversion mechanism 920 and the flow controller 940, respectively. Therefore, similar parts are not described further in this specification. However, the flow diversion mechanism 1020 and the flow controller 1040 may differ in the arrangement of the pair of displays 1075. For example, the flow diversion 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 the movable member 950. Thus, the exact volume of bodily fluids being transported through the movable members 1050a, 1050b, 1050c, and 1050d can be determined. As shown in Figure 55, the display 1075 of the housing 1001 may include a set of three illuminations, including a first illumination for small volumes (e.g., 5 mL), a second illumination for intermediate volumes (e.g., 20 mL), and a third illumination for acceptable and / or large volumes (e.g., 40 mL). Thus, when the flow of bodily fluid is transferred, for example, into the first movable member 1050a through the flow controller 1040 and the flow diversion mechanism 1020, the flow metering mechanism contained therein can transmit signals to the display, and the display can be operated to turn on the first illumination, second illumination and / or third illumination according to the volume of bodily fluid transferred through the movable member 1050.

[0131]

[1184] In other embodiments, the movable members 1050a, 1050b, 1050c, and 1050d can be moved from a first position to a second, third, or fourth position relative to the housing 1001. In such embodiments, these positions can be associated, for example, with the intended volume of body fluid to be transferred to the sample reservoir. For example, in some embodiments, the user can actuate (e.g., move) the movable member 1050a from its first position to its second position. In such embodiments, the second position can be associated, for example, with a small volume of body fluid to be transferred to the sample reservoir (e.g., 10 mL). In some embodiments, the housing 1001 and / or the movable member 1050a may include stoppers, locks, fasteners, protrusions, recesses, etc., that can temporarily hold the movable member 1050a in the second position until a small volume of sample has been transferred to the sample reservoir. Furthermore, when positioned in the second position, the display 1075 can be configured to illuminate a first illumination associated with a smaller volume, so as to show the user a preset volume of body fluid being transferred to the sample reservoir. Once the desired volume of body fluid has been transferred to the sample reservoir and fluidly isolated therein, the flow diversion mechanism 1020 can be configured to automatically return the movable member 1050a to its first position. In this way, the flow diversion mechanism 1020 and the flow controller 1040 can be physically and fluidly coupled to any number of sample reservoirs and used to transfer a precise volume of body fluid to each sample reservoir.

[0132]

[1185] Figure 56 is a flowchart of method 1190 for obtaining a predetermined sample volume of body fluid from a patient using a flowmetered transfer device. The flowmetered transfer device (also referred to herein as “collection device”) may be any of the transfer devices described herein. For example, in some embodiments, the transfer device may be the collection device 900 described above with reference to Figures 46 to 53. Thus, the transfer device may include an inlet port configured to be selectively positioned to have fluid communication with the patient, a pre-sample reservoir and a sample reservoir, and a flowmetering mechanism configured to measure the flow of body fluid from the patient to the pre-sample reservoir and the flow of body fluid to the sample reservoir. Method 1190 includes establishing fluid communication between the patient and the port of the flowmetered transfer device in 1191. For example, the port may be fluidically coupled to a needle or other lumen-defining device (e.g., a flexible sterile tube), and the needle or other lumen-defining device may be inserted into the patient’s body (e.g., a venipuncture event or other method of accessing body fluid).

[0133]

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

[0134]

[1187] In 1193, the flow of body fluid transferred from the patient to the presample reservoir is measured. For example, in some embodiments, the port may include a flow control mechanism that can measure the flow of body fluid passing through the port (for example, in a similar manner to that described above with respect to the flow control mechanism 967 of the collection device 900). Thus, a presample volume of body fluid is transferred to the presample reservoir. Method 1190 includes, in 1194, verifying that the presample volume of body fluid placed in the presample reservoir is a predetermined presample volume of body fluid via the flow metering mechanism of the flow metering transfer device. For example, the flow metering mechanism may include and / or be operably coupled to a display, etc. (for example, the display 975 and / or 975' of the collection device 900). The flow metering mechanism may be configured to present volume information on the display, as described above.

[0135]

[1188] When the presample volume of body fluid is placed in the presample reservoir, in 1195, the presample reservoir is fluidically isolated from the port, sealing the presample volume of body fluid within the presample reservoir. For example, in some cases, the flow controller and / or diversion mechanism can be actuated (or rotated) from a first position and / or first form to a second position and / or second form. When the flow controller and / or diversion mechanism is in the second form, the presample reservoir is fluidically isolated from the space outside the presample reservoir. In some embodiments, when the flow controller and / or diversion mechanism is driven to its second position and / or second form, in 1196, fluid communication is established between the port and the sample reservoir. For example, in some embodiments, the flowmetering transfer device may include a perforating member configured to perforate a portion of the sample reservoir (e.g., a membrane), a movable member (e.g., movable member 950), etc. Therefore, when the flow controller and / or flow diversion mechanism is in its second position and / or second form, the perforation of that portion of the sample reservoir is positioned to allow fluid communication between the sample reservoir and the port. As described above, the sample reservoir may include, for example, a negative pressure that can initiate the flow of bodily fluids from the patient to the sample reservoir.

[0136]

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

[0137]

[1190] Thus, a predetermined pre-sample volume of body fluid is collected, which may, for example, contain externally present microorganisms. 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 fraction of a volume in between. In other embodiments, the pre-sample volume may be greater than 50 mL or 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, by collecting the predetermined pre-sample volume, it is possible to ensure that the predetermined sample volume placed in one or more sample reservoirs is substantially free of externally present 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 another embodiment, the predetermined sample volume may be 60 mL. While the above describes transferring a sample volume of body fluid to a single sample reservoir, in other embodiments, a predetermined sample volume can be transferred to two or more sample reservoirs using a flow-metering transfer device. For example, in some embodiments, as described above, a predetermined pre-sample volume of body fluid can be collected in a pre-sample reservoir and fluidically isolated therein. With the pre-sample volume fluidically isolated, a predetermined sample volume can be transferred to a first sample reservoir, a predetermined sample volume to a second sample reservoir, and a predetermined sample volume to a third sample reservoir using a flow-metering transfer device. In such cases, the predetermined sample volume can be, for example, 20 mL, resulting in a total sample volume of 60 mL being placed in the first, second, and third reservoirs.

[0138]

[1191] Various embodiments of the fluid collection devices described herein can enable the collection of two (or more) sets of fluid (e.g., blood) samples from a single venipuncture. Current standard of care requires that several tests (e.g., blood cultures) be performed by obtaining samples from separate, independent fluid access points (e.g., via two separate venipunctures, via catheter + venipuncture, and / or a combination thereof). The embodiments described herein facilitate the acquisition of multiple samples for predetermined diagnostic tests (e.g., blood culture tests) from a single fluid access point (e.g., venipuncture), thereby reducing the annual number of venipunctures required to acquire these samples by half. This is equally beneficial for both patients and healthcare workers. The reduction in the number of venipunctures (and / or other blood access procedures) significantly reduces the risk of needle stick injuries to healthcare workers and can reduce patient-related complications (e.g., hematoma, thrombosis, phlebitis, infection, etc.) resulting from these procedures. Furthermore, reducing the number of fluid access procedures (e.g., venipuncture) reduces the use of supplies, labor, and waste associated with these procedures. The cost reductions achieved by the healthcare system are significant and represent an opportunity to promote improved patient outcomes for improved sample integrity, leading to more accurate patient diagnoses that inform the development and implementation of treatment plans, along with more efficient resource consumption. Fluid collection devices also significantly reduce the occurrence 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 "points of contact," thereby reducing the opportunity for external contamination. The devices described herein can also minimize the risk of needle stick injuries and infections for 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) may include and / or be partially formed from a disinfectant saturated material (e.g., housing 401). Current standards rely on healthcare workers placing individual disinfectant 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, (e.g.) device 400 may include disinfectant material placed inside device 400, so that when housing 401 is placed on top of a 4-pack (or 2-pack) bottle, as shown in Figure 16, the first point of contact from housing 401 and the tops of sample reservoirs 480, 480', 490, and 490' is the disinfectant material. Thus, the tops of sample reservoirs 480, 480', 490, and 490' are ensured to be properly disinfected before body fluids are inoculated into the sample reservoirs.

[0140]

[1193] While various embodiments have been specifically shown and described, various modifications of form and detail are possible. For example, the dial 445 (actuator) is shown and described as rotating in one direction with reference to Figures 19 to 22, but in other embodiments, the dial 445 (actuator) can be rotated in a first direction and a second direction opposite to the first direction. In such embodiments, the rotation in the second direction can be configured to move the collection device through any number of forms. In other embodiments, the rotation of the actuator in the second direction can be restricted. In some embodiments, the dial may include a mechanical stopper or lock to fluidly isolate a first volume of body fluid received from the patient (i.e., the contaminated sample). In other words, once a predetermined volume of body fluid is filled in the first reservoir (pre-sample reservoir), and the user rotates the dial (actuator) to begin drawing in an additional sample, the dial (actuator) cannot be moved back to establish fluid communication with the first sample volume (contained in the pre-sample reservoir).

[0141]

[1194] While several embodiments have been described above, it should be understood that they are presented merely as examples and not as limitations. Although various embodiments have been described as including specific features and / or combinations of 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, with reference to Figures 34 to 40, the collection device 700 is shown and described as having a first, second, third, fourth, or fifth form, but in other embodiments, the collection device described herein may have more or fewer forms. Furthermore, with reference to Figures 2 to 13, the collection device 200 is shown and described as having a vacuum collection tube as a pre-sample reservoir 270, but in other embodiments, the collection device 200 may have a chamber housed in a housing 201 similar to the collection device 400 of the embodiments presented in Figures 16 to 22, which includes a pre-sample reservoir 470 that is housed in a distribution member 429, and vice versa.

[0142]

[1195] It is also possible to change the specific configuration of various components. For example, the size and specific shape of various components may differ from the illustrated embodiments while still providing the functions described herein. More specifically, the size and shape of various components can be specifically selected for a desired flow rate of bodily fluid into the fluid reservoir. For example, although a flow metering mechanism 967 is specifically shown in Figure 49, any of the collection devices described herein can be used with any suitable flow metering mechanism. For example, in some embodiments, the collection device may include flow metering mechanisms and / or any other mechanisms, devices, or methods configured to measure the volume characteristics of a body fluid, such as pressure sensors, voltage sensors, optical sensors, velocity sensors, flow meters, strain gauges, valves, turbines, floats, displacement analysis, density analysis, gravimetric analysis, optical analysis, ultrasonic analysis, thermal analysis, Doppler analysis, electromagnetic field (EMF) analysis, reflection analysis, obstacle analysis, area analysis, Venturi analysis, Coriolis analysis, visual analysis, and / or any other suitable sensors, analyses, and / or calculations (for example, applying and / or using Boyle's law, the ideal gas law, force calculations (force = mass × acceleration), etc.) as an example.

Claims

1. A device for obtaining bodily fluid samples from patients, A presample reservoir configured to receive a first volume of bodily fluids extracted from the patient, A flow diversion mechanism comprising an inlet port, a first outlet port, and a second outlet port, wherein the inlet port is configured to be coupled to a lumen-defining device to receive body fluids from a patient, the first outlet port is configured to fluidly couple the pre-sample reservoir to the flow diversion mechanism, the second outlet port is configured to fluidly couple the sample reservoir to the flow diversion mechanism, and the flow diversion mechanism defines a first fluid channel configured to fluidly couple the first outlet port to the inlet port, and a second fluid channel configured to fluidly couple the second outlet port to the inlet port. A device comprising: a flow metering mechanism that is in fluid communication with the first fluid channel and the second fluid channel, configured to measure the flow of a first volume of body fluid into the pre-sample reservoir through the first fluid channel, and to measure the flow of a second volume of body fluid into the sample reservoir through the second fluid channel, and configured to display volume indicators related to the first volume and the second volume.

2. The apparatus according to claim 1, wherein a first volume of the body fluid flows in the first fluid channel during a first period, and a second volume of the body fluid flows in the second fluid channel after the first period during a second period.

3. The apparatus according to claim 1, wherein the first volume of the body fluid contains contaminants present on the skin, and the second volume of the body fluid is substantially free of contaminants present on the skin.

4. The apparatus according to claim 1, wherein the pre-sample reservoir is at least partially defined by a part of the current shunt mechanism.

5. The apparatus according to claim 1, wherein the volume indicator is a visual indicator.

6. The apparatus according to claim 1, wherein the flow diversion mechanism includes a movable member configured to move through the second outlet port to arrange the sample reservoir in fluid communication with the second fluid passage.

7. The apparatus according to claim 6, wherein the flow metering mechanism is at least partially disposed within a part of the movable member.

8. The apparatus according to claim 1, wherein the flow separation mechanism is configured to fluidly isolate at least a portion of the presample reservoir and the first fluid channel when the first volume of blood is placed in the presample reservoir.

9. The apparatus according to claim 1, wherein the flow diversion mechanism includes a third outlet port configured to fluidly couple a second sample reservoir to the flow diversion mechanism, and defines a third fluid passage configured to fluidly communicate the third outlet port with the inlet port.

10. The apparatus according to claim 1, further comprising a flow controller defining a first lumen and a second lumen, the flow controller configured to move between a first configuration in which the first lumen is arranged to fluidly communicate the first fluid passage to the inlet port, and a second configuration in which the second lumen is arranged to fluidly communicate the second fluid passage to the inlet port.

11. The apparatus according to claim 10, wherein the flow controller is configured to move from the first form to the second form after the first volume of the body fluid has been placed in the presample reservoir.

12. A device for obtaining bodily fluid samples from patients, A presample reservoir configured to receive a first volume of bodily fluids extracted from the patient, A flow diversion mechanism comprising an inlet port, a first outlet port, and a second outlet port, wherein the inlet port is configured to be coupled to a lumen-defining device to receive body fluids from a patient, the first outlet port is configured to fluidly couple the pre-sample reservoir to the flow diversion mechanism, and the second outlet port is configured to fluidly couple the sample reservoir to the flow diversion mechanism, A flow controller, at least partially disposed within the flow division mechanism, is configured to move between a first configuration in which the flow controller defines at least a portion of the 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 the fluid flow path between the inlet port and the second outlet port. A device comprising a movable member movably coupled to the flow diversion mechanism, the movable member being configured to move 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 in communication with the fluid flow path between the inlet port and the second outlet port, wherein the sample reservoir is configured to receive a second volume of bodily fluids withdrawn from the patient when the flow controller is in its second configuration and the movable member is in its second configuration.

13. The apparatus according to claim 12, wherein the first volume of the body fluid contains contaminants present on the skin, and the second volume of the body fluid is substantially free of contaminants present on the skin.

14. The apparatus according to claim 12, wherein the flow controller rotates between its first form and its second form relative to the flow diversion mechanism.

15. The apparatus according to claim 12, wherein the flow controller moves in linear motion relative to the flow diversion mechanism.

16. The apparatus according to claim 12, wherein the flow controller is configured to fluidly isolate the presample reservoir when it is in its second form.

17. The apparatus according to claim 12, further comprising a perforating member configured to perforate a portion of the sample reservoir when the movable member is in its second form.

18. The apparatus according to claim 12, wherein the movable member is coupled to a biasing member configured to maintain the movable member at least temporarily in its first form.

19. The apparatus according to claim 12, wherein the flow diversion mechanism includes a third outlet port configured to fluidly couple a second sample reservoir to the flow diversion mechanism.

20. The movable member is the first movable member, and the device is The apparatus according to claim 19, further comprising a second movable member configured to move through the third outlet port between a first configuration in which the second sample reservoir is fluidly isolated from a fluid passage defined between the inlet port and the third outlet port, and a second configuration in which the second sample reservoir is fluidly in communication with the fluid passage defined between the inlet port and the third outlet port, wherein the second sample reservoir is configured to receive a third volume of bodily fluid to be withdrawn from the patient when the flow controller is in its second configuration and the second movable member is in its second configuration.

21. A device for obtaining bodily fluid samples from patients, A presample reservoir configured to receive a first volume of bodily fluids extracted from the patient, A flow diversion mechanism comprising a housing and a distribution member, wherein the housing defines a first opening and a second opening, the first opening being in fluid communication with the pre-sample reservoir, the distribution member defining a fluid passage at least partially disposed within the housing and in fluid communication with the second opening, and the distribution member including a coupling portion configured to be in fluid communication with the passage and physically and fluidly coupled to the sample reservoir, A flow controller comprising an inlet port configured to be coupled to a lumen-defining device to receive bodily fluids from the patient, the flow controller being rotatably coupled to the flow diversion mechanism and configured to move 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.

22. The apparatus according to claim 21, wherein the first volume of the body fluid contains contaminants present on the skin, and the second volume of the body fluid is substantially free of contaminants present on the skin.

23. The apparatus according to claim 21, wherein the pre-sample reservoir is at least partially defined by a part of the distribution member.

24. The apparatus according to claim 21, wherein the connecting portion includes a perforating member configured to perforate a part of the sample reservoir and arrange the sample reservoir to be in fluid communication with the fluid channel.

25. The apparatus according to claim 24, wherein the perforation of a portion of the sample reservoir by the perforating member initiates the flow of body fluid from the patient into the sample reservoir through the inlet port and the flow path when the flow controller is in its second form.

26. The apparatus according to claim 21, wherein the first volume of the body fluid is a first predetermined volume of the body fluid, the fluid channel is configured to receive a second predetermined volume of the body fluid, and the second predetermined volume of the body fluid is related to the sample volume.

27. The apparatus according to claim 26, wherein the sample volume is between approximately 10 milliliters and approximately 50 milliliters.

28. The apparatus according to claim 26, wherein the sample volume is approximately 30 milliliters.

29. The apparatus according to claim 21, wherein the flow diversion mechanism includes a sealing member, and when the flow controller is coupled to the flow diversion mechanism, the sealing member is positioned between the housing and the flow controller such that it forms a substantially fluid-seal seal with the surface of the flow controller and the surface of the housing, and the sealing member defines a first opening and a second opening, the first opening of the sealing member being substantially coaxial with the first opening of the housing, and the second opening of the sealing member being substantially coaxial with the second opening of the housing.

30. A method for obtaining a predetermined sample volume of body fluid from a patient using a flow-metering transfer device, wherein the flow-metering transfer device includes a flow-dividing mechanism including an inlet port configured to be selectively positioned to provide fluid communication to a pre-sample reservoir and a sample reservoir, and a flow-metering mechanism configured to measure the flow of body fluid from the patient to the pre-sample reservoir and to the sample reservoir. The steps include establishing fluid communication between the patient and the port of the flow metering and transfer device, The steps include establishing fluid communication between the port and the presample reservoir, A step of measuring the flow of bodily fluids transferred from the patient to the presample reservoir, The steps include verifying, via the flow metering mechanism of the flow metering transfer device, that the presample volume of the body fluid placed in the presample reservoir is a predetermined presample volume of the body fluid, The steps include: fluidly isolating the presample reservoir from the port and sealing the presample volume of the body fluid within the presample reservoir; The steps include establishing fluid communication between the port and the sample reservoir, The steps include measuring the flow of bodily fluids transferred from the patient to the sample reservoir, A method comprising the step of verifying, via the flow metering mechanism of the flow metering transfer device, that the sample volume of the body fluid placed in the sample reservoir is a predetermined sample volume of body fluid.

31. The method according to claim 30, wherein the flow metering and transfer device includes a flow controller configured to move between a first mode in which fluid communication is established between the patient and the pre-sample reservoir and a second mode in which fluid communication is established between the patient and the sample reservoir.

32. The method according to claim 30, wherein the bodily fluid is blood.

33. The method according to claim 32, wherein the sample reservoir includes at least one of a culture medium for aerobic bacteria or a culture medium for anaerobic bacteria.

34. The method according to claim 30, wherein the predetermined presample volume is between approximately 1 milliliter and approximately 10 milliliters.

35. The method according to claim 30, wherein the predetermined sample volume is between approximately 20 milliliters and approximately 60 milliliters.

36. The method according to claim 30, wherein the predetermined sample volume is approximately 60 milliliters.

37. The aforementioned sample reservoir is the first sample reservoir, and the aforementioned sample volume is the first sample volume. After verifying that the volume of the first sample in the first sample reservoir is the predetermined sample volume, the step of establishing fluid communication between the port and the second sample reservoir, The steps include measuring the flow of bodily fluids transferred from the patient to the second sample reservoir, The method according to claim 30, further comprising the step of verifying, via the flow metering mechanism of the flow metering transfer device, that the second sample volume of the body fluid placed in the second sample reservoir is the predetermined sample volume of the body fluid.

38. The method according to claim 37, wherein the first sample volume and the second sample volume together are equal to approximately 20 milliliters and approximately 60 milliliters.

39. After verifying that the volume of the second sample in the second sample reservoir is the predetermined sample volume, the step of establishing fluid communication between the port and the third sample reservoir, The steps include measuring the flow of bodily fluids transferred from the patient to the third sample reservoir, The method according to claim 37, further comprising the step of verifying, via the flow metering mechanism of the flow metering transfer device, that the third sample volume of the body fluid placed in the third sample reservoir is the predetermined sample volume of the body fluid.

40. The method according to claim 39, wherein the first sample volume, the second sample volume, and the third sample volume are collectively equal to between approximately 30 milliliters and approximately 60 milliliters.

41. The method according to claim 39, wherein the first sample volume, the second sample volume, and the third sample volume together are equal to about 60 milliliters.

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