Sterile bodily-fluid collection device and methods

An apparatus includes a pre-sample reservoir, a diversion mechanism, and a flow metering mechanism. The diversion mechanism has an inlet port couplable to a lumen-defining device to receive bodily-fluids from a patient, a first outlet port fluidically couplable to the pre-sample reservoir, and a second outlet port fluidically couplable to a sample reservoir. The diversion mechanism defines a first fluid flow path and a second flow path that are configured to place the first outlet port and the second outlet port, respectively, in fluid communication with the inlet port. The flow metering mechanism is configured to meter a flow of a predetermined volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir, to meter a flow of a second volume of bodily-fluid through the second fluid flow path into the sample reservoir, and to display a volumetric indicator associated with the predetermined volume and the second volume.

BACKGROUND

Embodiments described herein relate generally to the parenteral procurement of bodily-fluid samples, and more particularly to devices and methods for parenterally-procuring bodily-fluid samples with reduced contamination from microbes or other contaminants exterior to the bodily-fluid source, such as dermally-residing microbes.

Health care practitioners routinely perform various types of microbial tests on patients using parenterally-obtained bodily-fluids. In some instances, patient samples (e.g., bodily-fluids) are tested for the presence of one or more potentially undesirable microbes, such as bacteria, fungi, or yeast (e.g.,Candida). Microbial testing may include incubating patient samples in one or more sterile vessels containing culture media that is conducive to microbial growth, real-time diagnostics, and/or molecular PCR-based approaches. Generally, when such microbes are present in the patient sample, the microbes flourish over time in the culture medium. After a variable amount of time (e.g., a few hours to several days), organism growth can be detected by automated, continuous monitoring. Such automated monitoring can detect carbon dioxide produced by organism growth. The culture medium can then be tested for the presence of the microbes. The presence of microbes in the culture medium suggests the presence of the same microbes in the patient sample which, in turn, suggests the presence of the same microbes in the bodily-fluid of the patient from which the sample was obtained. Accordingly, when microbes 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 undesired microbes from the patient.

Patient samples, however, can become contaminated during procurement and/or can be otherwise susceptible to false positive results. One way in which contamination of a patient sample may occur is by the transfer of microbes from a bodily surface (e.g., dermally-residing microbes) dislodged during needle insertion into a patient and subsequently transferred to a culture medium with the patient sample. The bodily surface and/or other undesirable external microbes may be dislodged either directly or via dislodged tissue fragments, hair follicles, sweat glands and other skin adnexal structures. Another possible source of contamination is from the person drawing the patient sample. For example, a doctor, phlebotomist, nurse, etc. can transfer contaminants from their body (e.g., finger, arms, etc.) to the patient sample and/or to the equipment containing the patient sample. Expanding further, equipment and/or devices used during a patient sample procurement process (e.g., patient to needle, needle/tubing to sample vessels, etc.) often include multiple fluidic interfaces that can each introduce points of potential contamination. The use of such equipment and/or devices typically includes manual intervention to connect and/or fluidically couple various interfaces. Since these interfaces are not preassembled and sterilized as a single fluidically coupled system, external contaminants can be introduced to the patient sample via the user (e.g., doctor, phlebotomist, etc.) and/or other sources (e.g. ambient air, contaminants on surfaces of tables and counters in patient room, microbes transferred from linens or clothing, etc.). In some instances, such contaminants may thrive in a culture medium and eventually yield a positive microbial test result, thereby falsely indicating the presence of such microbes in vivo.

In some instances, false positive results and/or false negative results can be attributed to a specific volume of the patient sample. For example, overfilling of volume-sensitive blood culture bottles can lead to false positive results as noted in the instructions for use and/or warning labeling from manufacturers of such culture bottles, as well as associated automated continuous monitoring microbial detection systems. On the other hand, as another example, insufficient patient sample volume within a culture medium can result in false negative results. By way of example, in a study performed by the Mayo Clinic entitled, “Optimized Pathogen Detection with 30-Compared to 20-Milliliter Blood Culture Draws,” published in the December 2011 issue of Journal of Clinical Microbiology, a patient sample volume of 20 milliliters (mL) can result in detection of about 80% of bacteremias present in a patient sample, a patient sample volume of 40 mL can result in detection of about 88% of the bacteremias, and a patient sample volume of 60 mL can result in detection of about 99% of the bacteremias.

Such inaccurate results as a result of contamination, insufficient patient sample volume, and/or the like are a concern when attempting to diagnose or treat a suspected illness or condition. For example, false negative results from microbial tests may result in a misdiagnosis and/or delayed treatment of a patient illness which, in some cases, could result in the death of the patient. Conversely, false positive results from microbial tests may result in the patient being unnecessarily subjected to one or more anti-microbial therapies, which may cause serious side effects to the patient including, for example, death, as well as produce an unnecessary burden and expense to the health care system due to extended length of patient stay and/or other complications associated with erroneous treatments. Additionally, the use of diagnostic imaging equipment attributable to these false positive results is also a concern from both a cost as well as patient safety perspective as unnecessary exposure to concentrated radiation associated with a variety of imaging procedures (e.g., CT scans) has many known adverse impacts on long-term patient health.

As such, a need exists for sterile “all-in-one” bodily-fluid collection devices and methods that reduce microbial contamination in bodily-fluid test samples by, for example, minimizing exposure of the patient sample and/or fluidic interfaces to ambient non-sterile conditions and/or other sources of external contamination. Additionally, a need exists for such bodily-fluid collection devices to include a means for accurately metering, measuring, and/or otherwise assessing and confirming a volume of bodily-fluid transferred from a patient to a sample reservoir or culture medium that can be visually, tactically, or otherwise communicated to a healthcare practitioner procuring the patient sample in substantially real-time (e.g. at the patient bedside).

SUMMARY

Devices for parenterally-procuring bodily-fluid samples with reduced contamination from microbes exterior to the bodily-fluid source, such as dermally-residing microbes and/or other undesirable external contaminants, are described herein. In some embodiments, an apparatus for obtaining a bodily fluid sample from a patient includes a pre-sample reservoir, a diversion mechanism, and a flow metering mechanism. The pre-sample reservoir is configured to receive a first volume of bodily-fluid withdrawn from the patient. The diversion mechanism includes an inlet port, a first outlet port, and a second outlet port, and defines a first fluid flow path and a second fluid flow path. The inlet port can be coupled to a lumen-defining device for receiving bodily-fluids from the patient. The first outlet port and the second outlet port are configured to fluidically couple the pre-sample reservoir and a sample reservoir, respectively, to the diversion mechanism. The first fluid flow path is configured to place the first outlet port in fluid communication with the inlet port and a second fluid flow path configured to place the second outlet port in fluid communication with the inlet port. The flow metering mechanism is in fluid communication with the first fluid flow path and the second fluid flow path. The flow metering mechanism is configured to meter a flow of the first volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir and to meter a flow of a second volume of bodily-fluid through the second fluid flow path into the sample reservoir. The flow metering mechanism is configured to display a volumetric indicator associated with the first volume and the second volume.

DETAILED DESCRIPTION

Devices for parenterally-procuring bodily-fluid samples with reduced contamination from microbes exterior to the bodily-fluid source, such as dermally-residing microbes and/or other undesirable external contaminants, are described herein. In some embodiments, an apparatus for obtaining a bodily fluid sample from a patient includes a pre-sample reservoir, a diversion mechanism, and a flow metering mechanism. The pre-sample reservoir is configured to receive a first volume of bodily-fluid withdrawn from the patient. The diversion mechanism includes an inlet port, a first outlet port, and a second outlet port, and defines a first fluid flow path and a second fluid flow path. The inlet port can be coupled to a lumen-defining device for receiving bodily-fluids from the patient. The first outlet port and the second outlet port are configured to fluidically couple the pre-sample reservoir and a sample reservoir, respectively, to the diversion mechanism. The first fluid flow path is configured to place the first outlet port in fluid communication with the inlet port and a second fluid flow path configured to place the second outlet port in fluid communication with the inlet port. The flow metering mechanism is in fluid communication with the first fluid flow path and the second fluid flow path. The flow metering mechanism is configured to meter a flow of the first volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir and to meter a flow of a second volume of bodily-fluid through the second fluid flow path into the sample reservoir. The flow metering mechanism is configured to display a volumetric indicator associated with the first volume and the second volume.

In some embodiments, an apparatus for obtaining a bodily-fluid sample from a patient includes a pre-sample reservoir, a diversion mechanism, a flow controller, and a movable member. The pre-sample reservoir is configured to receive a first volume of bodily-fluid withdrawn from the patient. The diversion mechanism includes an inlet port, a first outlet port, and a second outlet port. The inlet port is couplable to a lumen-defining device for receiving bodily-fluids from the patient. The first outlet port fluidically couples the pre-sample reservoir to the diversion mechanism and the second outlet port fluidically couples a sample reservoir to the diversion mechanism. The flow controller is at least partially disposed within the diversion mechanism and can be moved between a first configuration, in which the flow controller defines at least a portion of a fluid flow path between the inlet port and the first outlet port, and a second configuration, in which the flow controller defines at least a portion of a fluid flow path between the inlet port and the second outlet port. The movable member movably coupled to the diversion mechanism and movable through the second outlet port between a first configuration, in which the sample reservoir is fluidically 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 in fluid communication with the fluid flow path between the inlet port and the second outlet port. The sample reservoir is configured to receive a second volume of bodily-fluid withdrawn from the patient when the flow controller is in its second configuration and the movable member is in its second configuration.

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

In some embodiments, a method of using a flow-metering transfer device having a diversion mechanism with an inlet port configured to be selectively placed in fluid communication with a pre-sample reservoir and a sample reservoir, and a flow-metering mechanism configured to meter a flow of bodily-fluid from the patient to the pre-sample reservoir and to the sample reservoir includes establishing fluid communication between the patient and the inlet port of the flow-metering transfer device. Fluid communication is then established between the port and the pre-sample reservoir. A flow of bodily-fluid transferred from the patient to the pre-sample reservoir is metered. The method includes verifying a pre-sample volume of bodily-fluid disposed in the pre-sample reservoir is a first pre-sample volume of bodily-fluid via the flow-metering mechanism of the flow-metering transfer device. With the pre-sample volume disposed in the pre-sample reservoir, the pre-sample reservoir is fluidically isolated from the port to sequester the pre-sample volume of bodily-fluid in the pre-sample reservoir. With the pre-sample reservoir fluidically isolated, the method includes establishing fluid communication between the port and the sample reservoir. A flow of bodily-fluid transferred from the patient to the sample reservoir is metered. The method includes verifying a sample volume of bodily-fluid disposed in the sample reservoir is a first sample volume of bodily-fluid via the flow-metering mechanism of the flow-metering transfer device.

In some embodiments, an apparatus includes a diversion mechanism and a flow controller. The diversion mechanism can 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, and the third outlet port is fluidically coupled to a second sample reservoir, and so forth. All of the fluid reservoirs can be fluidically isolated from each other. The flow controller includes various fluidic channels that can allow fluidic movement in specified directions and can be configured to be operably coupled to the diversion mechanism. In use, when the diversion mechanism is at a first configuration, the flow controller can allow a flow of bodily-fluid to enter the pre-sample reservoir. The diversion mechanism can be moved to a second configuration, where the flow controller can allow a flow of bodily-fluid to enter the first sample reservoir. Additionally, the diversion mechanism can then be moved to a third configuration, whereby the flow controller can allow a flow of bodily-fluid to enter the second sample reservoir.

In some embodiments, a bodily-fluid collection device can be configured to selectively divert a first, predetermined volume of a bodily-fluid to a pre-sample reservoir before permitting the flow of a second volume of the bodily-fluid into a first sample reservoir and/or a third volume of the bodily-fluid into a second sample reservoir. In this manner, the second and/or third volumes of bodily-fluid can be used for diagnostic or other testing, while the first volume of bodily-fluid, which may contain microbes from a bodily surface or other source external to the patient from which the sample is procured, is isolated. In some embodiments, the bodily-fluid collection device can include additional sample reservoirs (e.g., 3, 4, 5, 6 or more) depending on the analysis and/or testing protocols to be performed.

In some embodiments, a bodily-fluid collection device can include flow metering to ensure the proper volume of bodily-fluid is collected from a patient and/or transferred into a specific pre-sample and/or sample reservoir. The bodily-fluid collection device can be configured to automatically divert and/or control the fluid flow after metered volumes of bodily-fluid are collected. For example, after a first metered pre-sample volume is collected, a diversion mechanism can be configured to divert the bodily-fluid flow to a first sample reservoir and then after a first metered sample volume is collected, the diversion mechanism can be configured to divert the bodily-fluid flow to a second sample reservoir and so on. In some embodiments, the bodily-fluid collection device can include a metered volume display such as, for example, a liquid crystal display (LCD), to provide a visual indication to the user of how much bodily-fluid has been collected into each specific, individual sample reservoir. In some embodiments, multiple displays can be provided to allow for customized pre-sample and/or sample volume collection.

As used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a member” is intended to mean a single member or a combination of members, “a material” is intended to mean one or more materials, or a combination thereof.

As used herein, “bodily-fluid” can include any fluid obtained from a body of a patient, including, but not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, and the like, or any combination thereof.

As used herein, the terms “first, predetermined amount,” “first amount,” and “first volume” describe an amount of bodily-fluid configured to be received or contained by a first reservoir or a pre-sample reservoir. While the terms “first amount” and “first volume” do not explicitly describe a predetermined amount, it should be understood that the first amount is the first, predetermined amount unless explicitly described differently.

As used herein, the terms “second amount” and “second volume” describe an amount of bodily-fluid configured to be received or contained by a second reservoir or sample reservoir. The second amount can be any suitable amount of bodily-fluid and need not be predetermined Conversely, when explicitly described as such, the second amount received and contained by the second reservoir or sample reservoir can be a second, predetermined amount.

As used herein, the term “set” can refer to multiple features or a singular feature with multiple parts. For example, when referring to set of walls, the set of walls can be considered as one wall with distinct portions, or the set of walls can be considered as multiple walls. Similarly stated, a monolithically constructed item can include a set of walls. Such a set of walls can include, for example, multiple portions that are in discontinuous from each other. A set of walls can also be fabricated from multiple items that are produced separately and are later joined together (e.g., via a weld, an adhesive or any suitable method).

As used herein, the terms “proximal” and “distal” refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device.

As used herein, the terms “about,” “approximately,” and “substantially” when used in connection with a numerical value is intended to convey that the value so defined is nominally the value stated. Said another way, the terms about, approximately, and substantially when used in connection with a numerical value generally include the value stated plus or minus a given tolerance. For example, in some instances, a suitable tolerance can be plus or minus 10% of the value stated; thus, about 0.5 would include 0.45 and 0.55, about 10 would include 9 to 11, about 1000 would include 900 to 1100. In other instances, a suitable tolerance can be plus or minus an acceptable percentage of the last significant figure in the value stated. For example, a suitable tolerance can be plus or minus 10% of the last significant figure; thus, about 10.1 would include 10.09 and 10.11, approximately 25 would include 24.5 and 25.5. Such variance can result from manufacturing tolerances or other practical considerations (such as, for example, tolerances associated with a measuring instrument, acceptable human error, or the like).

When describing a relationship between a predetermined volume of bodily-fluid and a collected volume of bodily-fluid it is to be understood that the values include a suitable tolerance such as those described above. For example, when stating that a collected volume of bodily-fluid is substantially equal to a predetermined volume of bodily-fluid, the collected volume and the predetermined volume are nominally equal within a suitable tolerance. In some instances, the tolerances can be determined by the intended use of the collected volume of bodily-fluid. For example, in some instances, an assay of a blood culture can be about 99% accurate when the collected volume of blood is within 1.0% to 5.0% of the manufacturer's (or evidence-based best practices) recommended volume. By way of an example, a manufacturer's recommended volume for an assay of a bodily-fluid can be 10 milliliters (mL) per sample collection bottle, with a total of four or six collection bottles used (i.e., an aggregate volume of 40 ml to 60 ml) plus or minus 5% for about 99% confidence. Thus, a collected volume of 10.5 mL would provide results with over about 99% confidence, while a collected volume of 11 mL would provide results with less than about 99% confidence. In other instances, a suitable tolerance can 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 fraction of a percent therebetween. In still other instances, a tolerance can be greater than 10.0%. Thus, any of the embodiments described herein can include and/or can be used in conjunction with any suitable flow-metering mechanism and/or device that is configured to meter a flow and/or otherwise measure a volume of bodily-fluid within a suitable tolerance. Moreover, the flow-metering mechanism and/or device can be arranged such as to minimize or eliminate tolerance stacking that can result from a combination of inaccurate measurement, human error, and/or the like.

FIG. 1is a schematic illustration of a portion of a bodily-fluid collection device100, according to an embodiment. Generally, the bodily-fluid collection device100(also referred to herein as “fluid collection device” or “collection device”) is configured to permit the withdrawal of bodily-fluid from a patient such that a first portion or volume of the withdrawn fluid is diverted away from a second and/or third portion or volume of the withdrawn fluid that is to be used as a biological sample, such as for testing for the purpose of medical diagnosis and/or treatment. In other words, the collection device100is configured to transfer a first, predetermined volume of a bodily-fluid to a pre-sample collection reservoir and a second and third volume (or, in some embodiments, a fourth, fifth and so on) of bodily-fluid to one or more sample collection reservoirs fluidically isolated from the pre-sample collection reservoir, as described in more detail herein.

The collection device100includes a diversion mechanism120, a flow controller140, a pre-sample reservoir170, a first sample reservoir180, and a second sample reservoir190, different than the first sample reservoir180. The diversion mechanism120includes an inlet port121and at least two outlet ports, such as a first outlet port125, and a second outlet port126as shown inFIG. 1. In some embodiments, the diversion mechanism120can include a set of outlet ports equal to a total number of pre-sample reservoirs and sample reservoirs. For example, the diversion mechanism120can include five outlet ports when the collection device100has one pre-sample reservoir and four sample reservoirs. In some embodiments, the diversion mechanism120can be operatively coupled to an actuator (not shown inFIG. 1) which can facilitate the movement of the diversion mechanism120between multiple configurations. The inlet port121is configured to be fluidically coupled to a medical device defining a pathway X for withdrawing and/or conveying the bodily-fluid from the patient to the collection device100. For example, the inlet port121can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). In this manner, the diversion mechanism120can receive the bodily-fluid from the patient via the needle or any other lumen-defining device.

The first outlet port125of the diversion mechanism120can be fluidically coupled to the pre-sample reservoir170. In some embodiments, the pre-sample reservoir170is monolithically formed with the first outlet port125and/or a portion of the diversion mechanism120. In other embodiments, the pre-sample reservoir170can be mechanically and/or fluidically coupled to the diversion mechanism120via an adhesive, a resistance fit, a mechanical fastener, any number of mating recesses, a threaded coupling, and/or any other suitable coupling or combination thereof. Similarly stated, the pre-sample reservoir170can be physically (e.g., mechanically) coupled to the diversion mechanism120such that an interior volume defined by the pre-sample reservoir170is in fluid communication with the first outlet port125of the diversion mechanism120. In still other embodiments, the pre-sample reservoir170can be operably coupled to the first outlet port125of the diversion mechanism120via an intervening structure (not shown inFIG. 1), such as flexible sterile tubing. More particularly, the intervening structure can define a lumen configured to place the pre-sample reservoir170in fluid communication with the first outlet port125.

The pre-sample reservoir170is configured to receive and contain the first, predetermined volume of the bodily-fluid. In some embodiments, the pre-sample reservoir170is configured to contain the first volume of the bodily-fluid such that the first volume is fluidically isolated from a second and/or third volume of the bodily-fluid (which can be the same or different than the first volume of bodily-fluid) that is subsequently withdrawn from the patient. The pre-sample reservoir170can be any suitable reservoir for containing a bodily-fluid, such as a pre-sample reservoir described in detail in U.S. Pat. No. 8,197,420 entitled, “Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination,” issued Jun. 12, 2012 (referred to henceforth as the “'420 patent”), the disclosure of which is incorporated herein by reference in its entirety.

In some embodiments, the second outlet port126of the diversion mechanism120is configured to be fluidically coupled to a lumen-defining device that can be coupled to the first sample reservoir180and the second sample reservoir190. Optionally, in other embodiments, the second outlet port126of the diversion mechanism120can be coupled to the first sample reservoir180and the diversion mechanism120can have a third outlet port (not shown) coupled to the second sample reservoir190. In some embodiments, the first sample reservoir180can be monolithically formed with the second outlet port126and/or a portion of the diversion mechanism120. In other embodiments, the first sample reservoir180can be mechanically coupled to the second outlet port126or operably coupled to the second outlet port126via an intervening structure, such as described above with reference to the pre-sample reservoir170. The first sample reservoir180is configured to receive and contain the second volume of the bodily-fluid. For example, the second volume of bodily-fluid can be an amount withdrawn from the patient subsequent to withdrawal of the first pre-sample volume. In some embodiments, the first sample reservoir180is configured to contain the second volume of the bodily-fluid in such a manner that the second volume is fluidically isolated from the first volume of the pre-sample bodily-fluid.

The first sample reservoir180and the second sample reservoir190can be any suitable sterile reservoir for containing a bodily-fluid including, for example, a sample reservoir as described in the '420 patent incorporated by reference above. In some embodiments, the second volume can be any suitable volume of bodily-fluid and need not be predetermined. In other embodiments, the transfer of the bodily-fluid to the first sample reservoir180and/or the second sample reservoir190can be metered or the like such that the second volume is a second predetermined volume.

The second sample reservoir190can be any suitable sample reservoir. In some embodiments, the second sample reservoir190can be substantially similar to the first sample reservoir180described above. The second sample reservoir190can be fluidically coupled to the second output port126as described above. The fluidic coupling of the second outlet port126to the second sample reservoir190can be substantially similar to the fluidic coupling of the second outlet port126to the first sample reservoir180, as described in detail above. Therefore, such portions are not described in further detail herein and should be considered substantially similar unless explicitly described differently. Furthermore, additional outlet ports of the diversion mechanism120and sample reservoirs (not shown inFIG. 1) can be substantially similar to the second outlet port126and the first sample reservoir180.

In some embodiments, the pre-sample reservoir170, the first sample reservoir180, and the second sample reservoir190can be coupled to (or formed with) the diversion mechanism120in a similar manner. In other embodiments, the pre-sample reservoir170, the first sample reservoir180, and the second sample reservoir190need not be similarly coupled to the diversion mechanism120. For example, in some embodiments, the pre-sample reservoir170can be monolithically formed with the diversion mechanism120(e.g., the first outlet port124) and the first sample reservoir180and/or the second sample reservoir190can be operably coupled to the diversion mechanism120(e.g., the second outlet port126) via an intervening structure, such as a flexible sterile tubing or any combination thereof.

In some embodiments, the collection device100can further include an actuator (not shown inFIG. 1) and a flow controller140that defines a first fluid flow path142, a second fluid flow path144, and optionally additional fluid flow paths (not shown inFIG. 1). In some embodiments, the actuator can be included in or otherwise operably coupled to the diversion mechanism120. In this manner, the actuator can be configured to control fluid movement within the flow controller140(e.g., between different configurations). For example, the actuator can be movable between a first position corresponding to a first configuration of the flow controller140, a second position, different than the first position, corresponding to a second configuration of the flow controller140, and so on. In some embodiments, the actuator can be configured for uni-directional movement. For example, the actuator can be moved from its first position to its second position, but cannot be moved from its second position to its first position. Similarly, the actuator can be moved from its second position to a third position, but cannot be moved from its third position back to its second position. In this manner, the flow controller140is prevented from being moved into its second or third configuration before its first configuration, thus requiring that the first amount of the bodily-fluid be directed to the pre-sample reservoir170and not the sample reservoirs180and/or190which is designed to contain the second and/or third volume of the withdrawn fluid that is to be used as a biological sample, such as for testing for the purpose of medical diagnosis and/or treatment.

The flow controller140is configured such that when in the first configuration, the first fluid flow path142fluidically couples the inlet port121to the first outlet port125, and when in the second configuration, the second fluid flow path144fluidically couples the inlet port121to the second outlet port126. In some embodiments, an actuator as described above can be configured to move the flow controller140in a translational motion between the first configuration, and the second configuration, and optionally a third or fourth configuration. For example, in some embodiments, the flow controller140can be in the first configuration when the flow controller140is in a distal position relative to the collection device100. In such embodiments, the actuator can be actuated to move the flow controller140in the proximal direction to a proximal position relative to the collection device100, thereby placing the flow controller130in the second configuration. In other embodiments, the actuator can also be actuated to move the flow controller140in a rotational motion between the first configuration and the second configuration or optionally a third or fourth configuration.

Accordingly, when the flow controller140is in the first configuration, the second outlet port126(and optionally additional outlet ports coupled to sample reservoirs) is fluidically isolated from the inlet port121. Similarly, when the flow controller140is in the second configuration, the first outlet port125is fluidically isolated from the inlet port121. And optionally, if the flow controller140is in a third configuration (not shown inFIG. 1), the first outlet port125and the second outlet port126are fluidically isolated from the inlet port121. In this manner, the flow controller140can direct, or divert the first amount of the bodily-fluid to the pre-sample fluid reservoir170via the first outlet port125when the flow controller140is in the first configuration and can direct, or divert the second amount of the bodily-fluid to the first sample fluid reservoir180via the second outlet port126when the flow controller140is in the second configuration.

In some embodiments, at least a portion of the actuator can be operably coupled to the pre-sample fluid reservoir170. In this manner, the actuator (or at least the portion of the actuator) can be configured to introduce or otherwise facilitate the development of a vacuum within the “pre-sample” fluid reservoir170, thereby initiating flow of the bodily-fluid through the collection device100and into the pre-sample fluid reservoir170when the diversion mechanism120is in its first configuration. The actuator can include any suitable mechanism for actuating the flow of bodily-fluid into the collection device100, such as, for example, a rotating disc, a plunger, a slide, a dial, a button, a handle, a lever, and/or any other suitable mechanism or combination thereof. Examples of suitable actuators are described in more detail herein with reference to specific embodiments.

In some embodiments, the diversion mechanism120can be configured such that the first amount of bodily-fluid need to be conveyed to the pre-sample fluid reservoir170before the diversion mechanism120will permit the flow of the second amount of bodily-fluid to be conveyed through the diversion mechanism120to the first sample fluid reservoir180and/or to the second sample fluid reservoir190. In this manner, the diversion mechanism120can be characterized as requiring compliance by a health care practitioner regarding the collection of the first, predetermined amount (e.g., a pre-sample) prior to a collection of the second and/or third amount (e.g., a sample) of bodily-fluid. Similarly stated, the diversion mechanism120can be configured to prevent a health care practitioner from collecting the second amount, or the sample, of bodily-fluid into the first sample fluid reservoir180without first diverting the first amount, or pre-sample, of bodily-fluid to the pre-sample reservoir170. In this manner, the health care practitioner is prevented from including (whether intentionally or unintentionally) the first amount of bodily-fluid, which is more likely to contain bodily surface microbes and/or other undesirable external contaminants, in the bodily-fluid sample to be used for analysis. In other embodiments, the fluid collection device100need not include a forced-compliance feature or component.

In some embodiments, the diversion mechanism120can have a fourth configuration (not shown inFIG. 1), different than the first, second, and third configurations. When in the fourth configuration, the diversion mechanism120can fluidically isolate the inlet port121from the first outlet port125, the second outlet port126, and optionally a third outlet port simultaneously. Therefore, when the diversion mechanism120is in its fourth configuration, flow of bodily-fluid from the inlet port121to the pre-sample fluid reservoir170, the first sample fluid reservoir180, and the second sample fluid reservoir190is prevented. In use, for example, the diversion mechanism120can be actuated (e.g., manually or automatically) to place the diversion mechanism120in the first configuration such that a bodily-fluid can flow from the inlet port121to the pre-sample fluid reservoir170, then moved to the second configuration such that the bodily-fluid can flow from the inlet port121to the first sample fluid reservoir180, and optionally moved to the third configuration such that the bodily-fluid can flow from the inlet port121to the second sample fluid reservoir190, then moved to the fourth configuration to stop the flow of bodily-fluid into and/or through the diversion mechanism120. In this manner, the device is effectively “locked” and self-contained in the fourth configuration such that any residual bodily-fluid in the device100is prevented from being communicated and/or otherwise exposing health care practitioner and/or patient to potential dangerous fluids. This optional safety feature can prevent potential exposure to bodily-fluid samples that can be infected with pathogens such as HIV, Hepatitis C, etc.

In some embodiments, one or more portions of the collection device100are disposed within a housing (not shown inFIG. 1). For example, in some embodiments, at least a portion of one or more of the diversion mechanism120, the first pre-sample reservoir170, and the sample reservoirs180and190can be disposed within the housing. In such an embodiment, at least a portion of the diversion mechanism120is accessible through the housing to allow the user to actuate the flow controller140to control the flow of bodily-fluid from the patient (e.g., a vein) to the collection device100. Examples of suitable housings are described in more detail herein with reference to specific embodiments.

In some embodiments, the collection device100can optionally include one or more flow metering devices that can meter a flow of bodily-fluid through the collection device. For example, a flow metering device can be in fluid communication with the first fluid flow path142and/or the second fluid flow path144to meter a flow of bodily-fluid therethrough. In other embodiments, a flow metering device can be in fluid communication with and/or otherwise disposed in the first port125and/or the second port126. The flow metering device can include an indicator or the like (e.g., a dial, a display, color, a haptic output device, an electrical signal output device such as a wireless radio signal, Bluetooth radio signal, etc.) that can be configured to provide an indication to a user that is associated with a predetermined volume being transferred to the pre-sample reservoir170, the first sample reservoir180, and/or the second sample reservoir190. In some embodiments, the flow metering device can be operably coupled to, for example, an actuator or the like such as those described above. In such embodiments, the flow metering device can be operable in actuating the actuator to move the flow controller140between its first configuration and its second configuration based on a desired volume of bodily-fluid having flown through the flow metering device. Thus, the flow metering device can be used to ensure a desired volume of bodily-fluid is transferred to the pre-sample reservoir170, the first sample reservoir180, and/or the second sample reservoir190, which in turn, can prevent insufficient, inaccurate and/or false results in, for example, microbial testing to the patient sample or the like.

Referring now toFIGS. 2-13, a collection device200includes a diversion mechanism220, a flow controller240, a pre-sample reservoir270, a first sample reservoir280, and a second sample reservoir290, different than the first sample reservoir280. As further described herein, the collection device200can be moved between a first, a second, and a third configuration to deliver a flow of a bodily-fluid that is substantially free from microbes exterior the body, such as, for example, dermally residing microbes and/or other undesirable external contaminants. The collection device200can be any suitable shape, size, or configuration. For example, while shown inFIGS. 2-13with the sample reservoirs280and/or290as being oriented vertically with respect to the housing201, the collection device200can have the sample reservoirs280and/or290oriented in a plane with respect to the housing201, or conically disposed with respect to the housing201, and/so forth.

The diversion mechanism220includes a housing201and movable members250and250′. As shown inFIGS. 2-4, the housing201is coupled to the pre-sample reservoir270, the first sample reservoir280, and the second sample reservoir290. The housing201includes an inlet port221, a first outlet port230, a second outlet port231, a third outlet port232, and defines an inner flow channel235that can define a fluid flow path for collecting bodily-fluids from the patient. The inlet port221can be selectively placed in fluid communication with the inner flow channel235. More specifically, the inlet port221defines an inlet lumen202that can be placed in fluid communication with the inner flow channel235. In this manner, the inlet port221extends from a portion of the housing201such that the inner flow channel235can be placed in fluid communication with a volume substantially outside the housing201, via the inlet lumen202. The inlet port221can be fluidically coupled to a medical device (not shown) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device200. For example, the inlet port221can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) either directly or indirectly via an adapter204. Similarly stated, the inlet lumen202defined by the inlet port221is placed in fluid communication with a lumen defined by a lumen-defining device, when the lumen-defining device is coupled to the inlet port221. Expanding further, when the lumen-defining device is disposed within a portion of a body of the patient (within a vein or the spinal cavity of a patient, for example), the inner flow channel235of the housing201can be placed in fluid communication with the portion of the body of the patient.

The inner flow channel235defined by the housing201is a central lumen that extends along a length of the housing201and that can be placed in fluid communication with the bodily-fluid of the patient following venipuncture (other method employed to gain access to bodily-fluid) as described herein. The inner flow channel235forms a fluid flow pathway for transferring bodily-fluid between the inlet port221and the first outlet port230, the second outlet port231, and the third outlet port232. More specifically, when the inner flow channel235is placed in fluid communication with the patient (e.g., via the medical device coupled to the inlet port221), the first outlet port230, the second outlet port231, and the third outlet port232can be selectively placed in fluid communication with the inner flow channel235to allow bodily-fluid to flow into at least one of the pre-sample reservoir270, the first sample reservoir280, or the second sample reservoir290. In some embodiments, the bodily-fluid is prevented from flowing to the second outlet port231and the third outlet port232prior to a predetermined volume of bodily-fluid being collected in the pre-sample reservoir270. In some embodiments, the second outlet port231and the third outlet port232can be placed in fluid communication with the inner flow channel235simultaneously. In some embodiments, the second outlet port231and the third outlet port232can be placed in fluid communication with the inner flow channel235sequentially.

The movable members250,250′ are configured to be actuated (e.g., moved) by the user from a first position and a second position relative to the housing201to direct fluid flow into the first sample reservoir280and the second sample reservoir290. The movable members250and250′ are substantially the same and therefore are described with reference to a single movable member250. As shown inFIG. 5, the movable member250includes a boss251that defines an inner cavity252, an inlet port253, a first outlet port254, and a piercing member255that defines a lumen256fluidically coupled to the inner cavity252. The inlet port253and the outlet port254extend through the walls of the boss251that defines the inner chamber252of the movable member250. The movable member250is configured to be mounted on a support257of the housing201(seeFIG. 4) such that the boss251is disposed within a bore258(seeFIG. 4) and at least a portion of the movable member250is received in an annular chamber260. Optionally, a bias member259(e.g., a spring) can be disposed in the annular chamber260to return the movable member250back to its first position after being actuated by the user. In some embodiments, the movable member250, the annular chamber260, the bore258or the boss251can include mechanical locking features configured to hold the movable member250in the second position (e.g., a depressed position) after being actuated by the user.

As described herein, in the first configuration, the movable member250is disposed in a manner such that the movable member250is spaced apart from the inner flow channel235. In such a configuration, no fluid flow path can be established between a part of the body of a patient (e.g., a vein, spinal cavity, etc.) and the sample reservoirs280and/or290. Said another way, when in the movable member250is in its first configuration, the first sample reservoir280and the second sample reservoir290are fluidically isolated from the inner flow channel235defined by the housing201. The movable member250can be actuated by the user to move the movable member250from the first configuration to the second configuration and into alignment with the inner flow channel235. The force exerted by the user can be sufficient to deform (e.g., compress) the bias member259, thereby allowing the piercing member255to be inserted into the sample reservoir280and/or290. In the second configuration, the inlet port253and the outlet port254are substantially aligned with the inner flow channel235placing the inner cavity252in fluid communication with the inner flow channel235. Thus, with the movable member250in the second configuration, a fluid flow pathway is established between the inner flow channel235, the inner cavity252, the lumen256of the piercing member255, and the sample reservoir280. Said another way, in such a configuration, bodily-fluid can flow from the patient (e.g., a vein, spinal cavity, etc.), through the diversion mechanism220, and into the first sample reservoir280and/or the second sample reservoir290as described in greater detail herein.

The pre-sample reservoir270can be any suitable reservoir for containing a bodily-fluid such as, for example, single use disposable collection tubes, vacuum based collection tubes, and/or the like. The pre-sample reservoir270is configured to be fluidically coupled to the first outlet port230of the collection device200(either directly or via an intervening structure such as sterile flexible tubing) in any suitable manner. For example, in some embodiments, a portion of the pre-sample reservoir270can form a friction fit within a portion of the first outlet port230. In other embodiments, the pre-sample reservoir270can be coupled to the first outlet port230via a threaded coupling, an adhesive, a snap fit, a mechanical fastener and/or any other suitable coupling method. In some embodiments, the pre-sample reservoir270can be monolithically formed with the housing201. The pre-sample reservoir270can be configured to maintain negative pressure conditions (vacuum conditions) inside (the pre-sample reservoir270) that can allow drawing of bodily-fluid from the inlet port221to the pre-sample reservoir270through outlet port230via vacuum suction. The pre-sample reservoir270is configured to contain the first amount of the bodily-fluid, where the first amount of bodily-fluid can be a predetermined or undetermined amount, such that the first amount of bodily-fluid is fluidically isolated from a second and/or third amount of the bodily-fluid that is subsequently withdrawn from the patient.

The sample reservoirs280and/or290can be any suitable reservoirs for containing a bodily-fluid, including, for example, single use disposable collection tubes, vacuum based collection tubes, a sample reservoir as described in the '420 patent incorporated by reference above, and/or the like. In some embodiments, sample reservoirs280and/or290can be substantially similar to or the same as known sample containers such as, for example, a Vacutainer®, or the like. The sample reservoir280and290include a sample container282and292, respectively, and a vacuum seal284and294, respectively. The vacuum seal284or294maintains negative pressure conditions (vacuum conditions) inside the sample container282or292, respectively, that can allow drawing of bodily-fluid from the inner flow channel235to the sample container282or292, respectively via vacuum suction. The sample reservoirs280and/or290can be configured to be fluidically coupled to the second outlet port231and third outlet port232, respectively, of the collection device200(either directly or via an intervening structure such as sterile flexible tubing) in any suitable manner. The sample reservoirs280and/or290can be moved relative to the outlet ports231and/or232to place the sample reservoirs280and/or290in fluid communication with the outlet ports231and/or232. The sample reservoirs280and290can be configured to contain a second or third amount of the bodily-fluid. The second or third amount of bodily-fluid can be a predetermined or undetermined amount, such that the second or third amount of bodily-fluid is fluidically isolated from the first amount of the bodily-fluid that is withdrawn from the patient. In some configurations, the sample reservoirs280and/or290can be coupled to the collection device200by being monolithically formed with the housing201in a manner similar to the pre-sample reservoir270, thus, they are not described in detail herein. In some instances, the sample reservoirs280and/or290can be transparent such that the user can have visual feedback to confirm bodily-fluid flow into the sample reservoirs280and/or290.

In some embodiments, the sample reservoirs280and290and the diversion mechanism220(and/or the portions of the collection device200other than the sample reservoirs280and290) are independently formed (e.g., not monolithically formed) and coupled together during, for example, a manufacturing process. In some instances, the sample reservoirs280and290can be coupled to the diversion mechanism220in a substantially sterile or hermetic environment (e.g., an environment filled with ethylene oxide or the like). Thus, the interface between the sample reservoirs280and290and the diversion mechanism220is substantially sterilized prior to use. Moreover, the collection device200can be shipped and/or stored in a pre-assembled manner such as to maintain the substantially sterile interface between the sample reservoirs280and290and the diversion mechanism220.

As shown inFIGS. 6 and 7, the flow controller240includes a first member241and a second member245. The first member241is configured to be disposed in a recess266of the housing201(see e.g.,FIG. 4), and can be made of any number of materials that are biocompatible such as, for example, titanium, graphite, pyrolytic carbon, polyester, polycarbonate, polyurethane, elastomeric material and/or the like. In some embodiments, the second member245serves as an actuator to move the first member241from a first configuration to a second configuration. More specifically, when the first member241is disposed in the recess266, the second member245can be moved between a first position and a second position to move the flow controller240between the first and second configuration. In some embodiments, the housing201can selectively limit movement of the second member245from its first position to its second position. In some embodiments, the housing201can be configured to prevent movement of the second member245once it has been moved to the second position. Said another way, the housing201can include a locking mechanism that prevents the second member245from being moved from the second position back to the first position. The second member245and/or the housing201can also include mechanical detents and/or other indicators that provide visual or tactile feedback to ensure precise positioning of the second member245.

The first member241can include multiple channels for directing fluid flow following a venipuncture (and/or other method of accessing a patient's bodily-fluid). For example, as shown inFIGS. 6 and 7, the first member241includes a first flow channel242and a second flow channel244. When the second member245is in the first position (see e.g.,FIGS. 8 and 9), the flow controller240is placed in the first configuration and the first flow channel242establishes fluid communication between the inlet port221and the first outlet port230while fluidically isolating the inlet port221from the inner flow channel235. When the second member245is in the second position (see e.g.,FIGS. 10-13), the flow controller240is placed in the second configuration and the second flow channel244establishes fluid communication between the inlet port221and the inner flow channel235while fluidically isolating the inlet port221from the first outlet port230. Additional second member245positions corresponding to additional first member241flow channels and/or flow controller240configurations can be included to further direct/isolate fluid flow between the patient and the collection device200. For example, the second member245can have a third position corresponding to a third configuration of the flow controller240that substantially prevents fluid flow between the patient and the collection device200altogether. Said another way, in some embodiments, the dial can be moved to a third position after all bodily-fluid samples are taken from the patient to substantially seal the samples in the collection device200from the external environment.

In operation, the collection device200can be used to collect bodily-fluids (e.g., blood) from a patient with reduced contamination from dermally-residing microbes and/or other undesirable external contaminants. For example, the inlet port221of the collection device200is fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) via the adapter204. Following venipuncture (or other bodily-fluid access method), the second member245is rotated until it reaches the first position as shown inFIGS. 8 and 9. Alternatively, the second member245can be pre-set in the first position and the collection device200can be otherwise sealed to preserve the vacuum in the pre-sample reservoir270and the sterility of the collection device200. For example, the inlet port221and/or the adapter204can include a valve that is opened when the collection device200is coupled to the needle or other lumen-defining device.

As described above, when the second member245is in the first position, the flow controller240is placed in the first configuration and the first flow channel242of the first member241establishes fluid communication between the inlet port221and the first outlet port230while fluidically isolating the inlet port221from the inner flow channel235. Additionally, the first and second sample reservoirs280and290are fluidically isolated from the inlet port221in the first configuration and a fluid flow path is defined between a portion of the body of a patient (e.g. a vein) and the pre-sample reservoir270as indicated by the arrow AA inFIG. 9. As described above, fluid reservoirs used in the collection device200such as the pre-sample reservoir270, and the sample reservoirs280and290can be configured to define a negative pressure (i.e., a pressure less than the fluid pressure of the portion of the body that the collection device200is being used to withdraw bodily-fluid from) so that once fluid communication is established between a portion of the body of the patient (e.g., a vein) and the pre-sample reservoir270, the negative pressure within the pre-sample reservoir270is such that the pressure differential between the pre-sample reservoir270and the portion of the body of the patient draws the bodily-fluid into the pre-sample reservoir270. In this first configuration, the flow controller240also fluidically isolates the pre-sample reservoir270from the inner flow channel235. Thus, a first amount (predetermined or undetermined) of bodily-fluid can be received into the pre-sample reservoir270immediately after venipuncture (for example) and isolated from subsequent samples. In this manner, the collection device200can be used to prevent the first amount of bodily-fluid, which is most likely to contain bodily surface microbes and/or other undesirable external contaminants, from contaminating subsequent amounts of the bodily-fluid samples that are collected and used for diagnostic or other testing that can be impacted by the contaminants.

Following collection of the volume of bodily-fluid pre-sample in the pre-sample reservoir270, the second member245can be rotated until it reaches the second position as shown inFIGS. 10 and 11. When the second member245is in the second position, the flow controller240is placed in the second configuration and the second flow channel244of the first member241establishes fluid communication between the inlet port221and the inner flow channel235, while fluidically isolating the first outlet port230(i.e., the pre-sample reservoir270) from the inlet port221. Said another way, in the second configuration, the flow controller240establishes a fluid flow path between a portion of the body of a patient (e.g. a vein) and the inner flow channel235via the second flow channel244as indicated by arrow BB inFIG. 11.

With the flow controller240in the second configuration, the movable members250and/or250′ can be actuated (i.e., depressed) from the first position to the second position by the user to establish fluid communication between a part of the body of a patient (e.g., a vein) and the first sample reservoir280and/or the second sample reservoir290. More specifically, the movable member250is moved from its first position to its second configuration to pass the piercing member255through the outlet port231in such a manner that the piercing member255can puncture the vacuum seal284of the first sample reservoir280to be disposed inside the sample container282, as indicated by the arrow CC inFIG. 12. While in the second position, the inlet port253and the outlet port254of the movable member250are substantially aligned with, and in fluid communication with, the inner flow channel235, which allows the bodily-fluid to flow from the inner flow channel235, into the inner cavity252of the movable member250, and out the lumen256of the piercing member255into the first sample reservoir280. The pressure differential between the sample reservoir280(e.g., vacuum or negative pressure) and the inner flow channel235draws the bodily-fluid into the sample reservoir280. Said another way, in the second configuration, the movable member250establishes a fluid flow path between the inner flow channel235and the first sample reservoir280as indicated by the arrow DD inFIG. 12. Once a desired volume of bodily-fluid (e.g., the second amount) is collected in the first sample reservoir280, the user can release the movable member250allowing the bias member259to move the button250back to its first position. With the movable member250back in its first position, the piercing member255is removed from the first sample reservoir280and the seal284(e.g., a self sealing septum) fluidically isolates the first sample reservoir280from the inner flow channel235.

In a similar manner, while the flow controller240is in the second configuration, the movable member250′ can be actuated (depressed) from its first position to its second position by the user, as indicated by the arrow EE inFIG. 13. In this manner, fluid communication is established between a part of the body of a patient (e.g., a vein) and the second sample reservoir290(via the outlet port232) in a manner similar to that of the movable member250and first sample reservoir280described above. Said another way, in the second configuration, the movable member250′ establishes a fluid flow path between the inner flow channel235and the second sample reservoir290as indicated by the arrow FF inFIG. 13. Once a desired volume of bodily-fluid (e.g., the third amount) is collected in the second sample reservoir290, the user can release the movable member250′ allowing the bias member259′ to move the button250′ back to its first position. Although shown and described as being a sequential process, the order of fill and/or sequencing is not necessarily required (i.e., sample reservoir280does not necessarily have to be filled before sample reservoir290, etc.). Said another way, once the flow controller240is moved to the second configuration, the first sample reservoir280and the second sample reservoir290(and any additional sample reservoirs) can be filled in any order, at the same time (e.g., simultaneously), and/or at overlapping time intervals. For example, the user can begin to fill the first sample reservoir280and then after the first sample reservoir280is partially filled, the user can depress the movable member250′ to being filling the second sample reservoir290while the first sample reservoir280is finished filling. Additionally, adjustments in the volume of the bodily-fluid collected in the sample reservoirs280and/or290can be made possible by actuating (inserting) the movable members250and/or250′ repeatedly. As described above, the second member245can have a third position corresponding to a third configuration of the flow controller240that can substantially prevent fluid flow between the patient and the collection device200altogether to substantially seal the samples in the collection device200from the external environment.

Although not shown inFIGS. 2-13, the collection device200can include a flow metering device or the like that can be configured to meter a volume of bodily-fluid that is transferred to the pre-sample reservoir270, the first sample reservoir280, and/or the second sample reservoir290. For example, in some embodiments, the first member241of the flow controller240can include a flow metering device that is in fluid communication with the first flow channel242and the second flow channel244. In other embodiments, a flow metering device can be disposed within the inner cavity252of the movable members250and/or250′. Thus, a volume of bodily-fluid sample transferred to and disposed in the first sample reservoir280and the second sample reservoir290can be metered and/or controlled such that the volume of bodily-fluid sample disposed in each sample reservoir280and290is a predetermined volume such as, for example, 10 mL, 20 mL, 30 mL, etc.

Although the collection device200is shown and described as including a first sample reservoir280and a second sample reservoir290, in other embodiments, a collection device can include any number of pre-sample and/or sample reservoirs. For example,FIGS. 14 and 15illustrate a collection device300according to an embodiment. As shown, certain aspects of the collection device300can be substantially similar to corresponding aspects of the collection device200described above with reference toFIGS. 2-13. Thus, similar aspects are not described in further detail herein.

As shown inFIGS. 14 and 15, the collection device300includes a diversion mechanism320, a flow controller340, a pre-sample reservoir370, a first sample reservoir380, a second sample reservoir380′, a third sample reservoir390, and a fourth sample reservoir390′. The pre-sample reservoir370can be substantially similar to the pre-sample reservoir270described in detail above. In some embodiments, the sample reservoirs380,380′,390, and390′ can be substantially similar to the sample reservoirs280and290described in detail above. In some embodiments, the sample reservoirs380,380′,390, and390′ can have substantially the same shape and size and can include, for example substantially the same culture medium. In other embodiments, the sample reservoirs380,380′,390, and390′ can have substantially the same shape and size and can include one of an aerobic culture medium or an anaerobic culture medium. For example in some embodiment, the first sample reservoir380and the third sample reservoir390can include an aerobic culture medium, while the second sample reservoir380′ and the fourth sample reservoir390′ can include an anaerobic culture medium. In other embodiments, the sample reservoirs380,380′,390, and390′ can each include an aerobic or an anaerobic culture medium in any arrangement or combination.

The diversion mechanism320includes a housing301and a set of movable members350,350′,350″, and350′″. The movable members350,350′,350″, and350′″ are, for example, substantially similar to the movable member250described above with reference toFIG. 5. Thus, the movable members350,350′,350″, and350′″ can be moved between a first position and a second position relative to the housing301to be placed in fluid communication with the sample reservoirs380,380′,390, and390′, respectively. The housing301includes and/or defines an inlet port321, a first outlet port330configured to be placed in fluid communication with the pre-sample reservoir370, a second outlet port331configured to be placed in fluid communication with the first sample reservoir380, a third outlet port332configured to be placed in fluid communication with the second sample reservoir380′, a fourth outlet port333configured to be placed in fluid communication with the third sample reservoir390′, and a fifth outlet port334configured to be placed in fluid communication with the fourth sample reservoir390′. Moreover, the housing301defines an inner flow channel335that can be selectively placed in fluid communication with the inlet port321and the outlet ports331,332,333, and334in a similar manner as described above with reference to the inner flow channel235of the housing201.

The flow controller340is, for example, substantially similar to the flow controller240described above with reference toFIGS. 6-13. Thus, the flow controller340can be rotated between a first configuration and a second configuration to selectively define a portion of a fluid flow path between the patient and the pre-sample reservoir370or the sample reservoirs380,380′,390, and390′. In this manner, a user can manipulate the collection device300in a similar manner as described above with reference to the collection device200inFIGS. 8-13. Thus, a first volume of bodily-fluid can be transferred to and disposed in the pre-sample reservoir370and subsequent volumes of bodily-fluid can be transferred to and disposed in the sample reservoirs380,380′,390, and390′.

FIGS. 16-22illustrate a collection device400according to an embodiment. The collection device400includes a diversion mechanism420, a flow controller440, and sample reservoirs480,480′,490and490′. As further described herein, the collection device400can be moved between a first, a second, a third, a fourth, and a fifth configuration to deliver a flow of a bodily-fluid that is substantially free from microbes exterior the body, such as, for example, dermally residing microbes and/or other undesirable external contaminants. The collection device400can be any suitable shape, size, or configuration. For example, while shown inFIGS. 16-22with the sample reservoirs480,480′,490and490′ oriented vertically with respect to the housing401, the collection device400can have the sample reservoirs480,480′,490and490′ oriented in any suitable plane with respect to the housing401, or conically disposed with respect to the housing401, and/so forth.

The sample reservoirs480,480′,490and490′ are substantially similar or the same in form and function to the sample reservoirs280and/or290of the collection device200and thus, are not described in detail herein. As discussed above, the sample reservoirs480,480′,490and490′ maintain negative pressure conditions (vacuum conditions) that can allow drawing of bodily-fluid from a patient to the sample reservoirs480,480′,490and490′ via suction. In some embodiments, sample reservoirs480and480′ can be aerobic culture bottles and sample reservoirs490and490′ can be anaerobic culture bottles and the collection device400can be used to collect multiple aerobic and multiple anaerobic blood culture samples from a single venipuncture. As described in further detail herein, the sample reservoirs480,480′,490and490′ can each be placed in fluid communication with at least a portion of the diversion mechanism420to receive a volume of a bodily-fluid sample. The volume of the bodily-fluid samples can be a predetermined or undetermined amount. Moreover, once a desired volume of bodily-fluid is disposed in the sample reservoirs480,480′,490,490′, each sample reservoir480,480′,490, and490′ can be fluidically isolated from at least a portion of the diversion mechanism420, as described in further detail herein.

The diversion mechanism420includes a housing401and a distribution member429. The housing401of the diversion mechanism420is physically and fluidically coupled to the distribution member429, and provides and/or defines a set of fluid flow pathways for collecting bodily-fluids from the patient. The housing401defines a recess466and a set of outlet apertures403. The recess466is configured to receive a seal member441included in the flow controller440, as described in further detail herein. The set of outlet apertures403includes a first outlet aperture403a, a second outlet aperture403b, a third outlet aperture403c, a fourth outlet aperture403d, and a fifth outlet aperture403ethat are each configured to define a different fluid flow path in fluid communication with different portions of the distribution member429. More specifically, the distribution member429defines and/or forms at least a portion of a pre-sample reservoir470in fluid communication with the first outlet aperture403a, and a first flow channel435ain fluid communication with the second outlet aperture403b, second flow channel435bin fluid communication with the third outlet aperture403b, a third flow channel435cin fluid communication with the fourth outlet aperture403d, and a fourth flow channel435in fluid communication with the fifth outlet aperture403e.

As shown inFIGS. 17 and 18, the distribution member429defines a chamber or volume that defines at least a portion of the pre-sample reservoir470. The pre-sample reservoir470is configured to contain bodily-fluids such as, for example, blood, plasma, urine, and/or the like. The first outlet aperture403aof the housing401can be substantially aligned with an open portion of the pre-sample reservoir470to allow the pre-sample reservoir470to receive a flow of bodily-fluid from the patient. For example, the pre-sample reservoir470can receive and contain a first amount or volume of the bodily-fluid, where the first amount of bodily-fluid can be a predetermined or undetermined amount. Moreover, the arrangement of the diversion mechanism420can be such that the pre-sample reservoir470is maintained in fluidic isolation from the flow channels435a,435b,435c, and435dand/or subsequent volumes of bodily-fluid withdrawn from the patient, as described in further detail herein. While the pre-sample reservoirs270and370are described above as maintaining a negative pressure, the pre-sample reservoir470does not maintain negative pressure conditions (vacuum conditions), and hence other mechanisms such as, for example, gravitational pull can be used to draw the bodily-fluid into the pre-sample reservoir470.

The flow channels435a-435dextend radially from a center of the distribution member429and are arranged such that each flow channel435a,435b,435c, and435dis fluidically isolated from the pre-sample reservoir470and the other flow channels. In this manner, the flow channels435a,435b,435c, and435dcan direct and/or otherwise define a fluid flow path between a first end portion that is substantially aligned with the outlet apertures403b,403c,403d, and403e, respectively, and a second end portion. As shown inFIGS. 17 and 18, the distribution member429defines a first outlet port431disposed at the second end portion of the first flow channel435a, a second outlet port432disposed at the second end portion of the second flow channel435b, a third outlet port433disposed at the second end portion of the third flow channel435c, and a fourth outlet port434disposed at the second end portion of the fourth flow channel435d. Moreover, the distribution member429includes a first piercing member455a, a second piercing member455b, a third piercing member455c, and a fourth piercing member455dthat are physically and fluidically coupled to the first outlet port431, the second outlet port432, the third outlet port433, and the fourth outlet port434, respectively. As such, the piercing members455a-355dcan be used to puncture a vacuum seal of the sample reservoirs480,480′,490and490′ which can initiate a flow of bodily-fluid, as described in further detail herein. Although not shown inFIGS. 17 and 18, the sample reservoirs480,480′,490and490′ can be physically coupled to a portion of the distribution member429(either directly or via an intervening structure such as sterile flexible tubing) in any suitable manner that can allow the sample reservoirs480,480′,490, and490′ to be placed in fluid communication with the outlet ports431,432,433, and434, respectively.

The flow controller440includes a dial445and a seal member441. The seal member441is disposed in the recess466of the housing401(see e.g.,FIG. 20). More particularly, the flow controller440can be coupled to the housing401such that the seal member441is disposed between and in contact with a surface of the housing401defining the recess466and a surface of the dial445. Moreover, the seal member441can have a size and a shape such that, when the flow controller440is coupled to the housing401, the seal member441forms a substantially fluid tight seal with the surface of the dial445and the surface of the housing401that defines the recess466(see e.g.,FIG. 20), as described in further detail herein. The seal member441can be made of any number of materials that are biocompatible such as, for example, silicone, polylactides, polyglycolides, polylactide-co-glycolides (PLGA), polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, nylons, polyesters, polycarbonates, polyacrylates, polymers of ethylene-vinyl acetates and other acyl substituted cellulose acetates, polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonate polyolefins, polyethylene oxide, and/or blends and copolymers thereof.

As shown inFIG. 17, the seal member441defines a set of apertures444that can direct a flow of bodily-fluid following a venipuncture (or other method of accessing bodily-fluid). For example, the set of apertures444defined by the seal member441includes a first aperture444a, a second aperture444b, a third aperture444c, a fourth aperture444d, and a fifth aperture444e. The arrangement of the seal member441is such that when the seal member441is disposed in the recess466, the first aperture444a, the second aperture444b, the third aperture444c, the fourth aperture444d, and the fifth aperture444eare substantially aligned with the first outlet aperture403a, the second outlet aperture403b, the third outlet aperture403c, the fourth outlet aperture403d, and the fifth outlet aperture403eof the housing401, respectively.

The dial445of the flow controller440is rotatably coupled to the housing401and movable between a first position, a second position, a third position, a fourth position, and a fifth position relative to the housing401. The dial445includes an inlet port421that defines a lumen402. The inlet port421can be fluidically coupled to a medical device (not shown) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device400. For example, the inlet port421can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) either directly or indirectly via an adapter404. Similarly stated, the inlet lumen402defined by the inlet port421is placed in fluid communication with a lumen defined by a lumen-defining device, when the lumen-defining device is coupled to the inlet port421. In this manner, the inlet port421can be configured to selectively place the pre-sample reservoir470, the first sample reservoir480, the second sample reservoir480′, the third sample reservoir490, and the fourth sample reservoir490′ in fluid communication with the patient, as described in further detail herein.

As described above, the dial445is movable between the first, the second, the third, the fourth, and the fifth positions. When the dial445is in the first position, the flow controller440is placed in a first configuration and the inlet port421can be substantially aligned with the first aperture444aof the seal member441and the first outlet aperture403aof the housing401. In this manner, first aperture444aof the seal member441establishes fluid communication between the inlet port421and the first outlet aperture403awhile fluidically isolating the inlet port421from the outlet apertures403b,403c,403d, and403ewhich in turn, fluidically isolates the inlet port421from the flow channels435a-335d. With the first outlet port403aaligned with an open portion of the pre-sample reservoir470, the first aperture444aand the first outlet aperture403aestablish fluid communication between the inlet port421and the pre-sample reservoir470. When the dial445is rotated (or actuated) to the second position, the flow controller440is placed in a second configuration and the second outlet aperture444bestablishes fluid communication between the inlet port421and the second outlet aperture403bwhile fluidically isolating the inlet port421from the outlet apertures403a,403c,403d, and403e. With the second outlet aperture403baligned with the first end portion of the first flow channel435a, the second aperture444band the second outlet aperture403bestablish fluid communication between the inlet port421and the first flow channel435a.

The collection device400works in a similar manner when the dial445is rotated to the third, fourth and fifth positions. Thus, when the inlet lumen402is placed in fluid communication with the patient (e.g., via the medical device coupled to the inlet port421), the first outlet port430, the second outlet port431, the third outlet port432, the fourth outlet port433, and the fifth outlet port434can be selectively placed in fluid communication with the inlet lumen402to allow all the bodily-fluid to flow into at least one of the pre-sample reservoir470, or one or more of the sample reservoirs480,480′,490and490′. In some embodiments, additional dial445positions corresponding to additional seal outlet apertures and/or flow controller440configurations can be included to further direct/isolate fluid flow between the patient and the collection device400. For example, the dial445can have a sixth position corresponding to a sixth configuration of the flow controller440that substantially prevents fluid flow between the patient and the collection device400altogether. Said another way, in some embodiments, the dial445can be moved to a sixth position after all bodily-fluid samples are taken from the patient to substantially seal the samples in the collection device400from the external environment.

In some embodiments, the bodily-fluid is prevented from flowing to the outlet ports associated with the sample reservoirs (e.g., outlet ports431-434) until after a predetermined volume of bodily-fluid is collected in the pre-sample reservoir470. In some embodiments, the outlet ports associated with the sample reservoirs (e.g., outlet ports431-434) can only be placed in fluid communication with the inlet lumen402sequentially (e.g., outlet port431must be in fluid communication with the inlet lumen402before outlet port432, and so on). In some embodiments, the outlet ports associated with subsequent sample reservoirs (e.g., outlet ports432-434) can only be placed in fluid communication with the inlet lumen402after a confirmed volume of bodily-fluid has been collected. In some embodiments, the outlet ports associated with the sample reservoirs (e.g., outlet ports431-434) can be placed in fluid communication with the inlet lumen402in any random manner without any preference for order (e.g., outlet port434can be in fluid communication with the inlet lumen402before outlet port431, outlet port432can be in fluid communication with the inlet lumen402before outlet port433, and so on).

In some embodiments, the housing401can selectively limit movement of the dial445from its first position to its second, third, fourth, and fifth positions. In some embodiments, the housing401can be configured to prevent movement of the dial445once it has been moved to the fifth position. Said another way, the housing401can include a locking mechanism that prevents the dial445from being moved from the fifth position back to the first position. The dial445and/or the housing401can also include mechanical detents and/or other indicators that provide visual or tactile feedback to ensure precise positioning of the dial445with respect to the outlet apertures403a-403eof the housing401.

In operation, the collection device400can be used to collect bodily-fluids (e.g., blood, plasma, urine, and/or the like) from a patient with reduced contamination. For example, the inlet port421of the collection device400can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). Following venipuncture (or other method of accessing bodily-fluid), the dial445is actuated (or rotated) until it reaches the first position, as shown inFIGS. 19 and 20. Alternatively, the dial445can be pre-set in the first position and the collection device400can be otherwise sealed to preserve the sterility of the collection device400. For example, the inlet port421can include a valve that is opened when the collection device400is coupled to the needle or other lumen-defining device.

As described above, when the dial445is in the first position, the flow controller440is placed in the first configuration and the first aperture444aof the seal member441establishes fluid communication between the inlet port421and the first outlet port430(contained within the housing401) while fluidically isolating the inlet port421from the four flow channels435a-335d. Additionally, the sample reservoirs480,480′,490and490′ are fluidically isolated from the inlet port421in the first configuration and a fluid flow path is defined between a portion of the body of a patient (e.g. a vein) and the pre-sample reservoir470as indicated by the arrow GG inFIG. 20. In this first configuration, the bodily-fluid flows (e.g., by gravitation force, vacuum, etc.) from the portion of the body of the patient through the inlet lumen402of the inlet port421, the first aperture444aof the seal member441, the first outlet port430, and into the pre-sample reservoir470. In the first configuration, the flow controller440also fluidically isolates the pre-sample reservoir470from the flow channels435a-335d. Thus, a first amount (predetermined or undetermined) of bodily-fluid can be received into the pre-sample reservoir470immediately after venipuncture and isolated from subsequent samples. In this manner, the collection device400can be used to prevent the first amount of bodily-fluid, which is most likely to contain bodily surface microbes and/or other undesirable external contaminants, from contaminating subsequent amounts of the bodily-fluid samples that are collected and used for diagnostic or other testing that can be impacted by the contaminants.

Following collection of the bodily-fluid pre-sample in the pre-sample reservoir470, the dial445can be actuated (or rotated) until it reaches the second position as shown inFIGS. 21 and 22. When the dial445is in the second position, the flow controller440is placed in the second configuration and the second aperture444bof the seal member441establishes fluid communication between the inlet port421and the flow channel435a, while fluidically isolating the pre-sample reservoir470from the inlet port421. Said another way, in the second configuration, the flow controller440establishes a fluid flow path between a portion of the body of a patient (e.g. a vein) and the flow channel435a, as indicated by the arrow HH inFIG. 22. With the flow controller440in the second configuration, the sample reservoir480can be actuated by the user (e.g., pushed against the piercing member455a) from a first configuration to a second configuration to establish fluid communication between a part of the body of a patient (e.g., a vein) and the first sample reservoir480.

As described above, moving the sample reservoir480to the second configuration results in the piercing member455apuncturing the vacuum seal of the sample reservoir480to be disposed inside the sample reservoir480. In this second configuration, the part of the body of a patient (e.g., a vein) is exposed to vacuum suction force from the sample reservoir480due to the negative pressure conditions (vacuum) therein. The pressure differential between the sample reservoir480(e.g., vacuum or negative pressure) and the part of the body of the patient draws the bodily-fluid into the sample reservoir480. The bodily-fluid flows from the part of the body of a patient through the inlet lumen402of the inlet port421, the second aperture444bof the seal member441, the second outlet aperture403bof the housing401, and into the first flow channel435a. The vacuum suction draws the flow of bodily-fluid through the first flow channel435ainto the sample reservoir480via the second outlet port431and the piercing member455a. Said another way, in the second configuration, the flow controller440establishes a fluid flow path between the inlet port421and the sample reservoir480. Once a desired volume of bodily-fluid (e.g., the second amount) is collected in the sample reservoir480, the user can actuate (rotate) the flow controller440to the third position and/or move the sample reservoir480back to its first configuration to isolate the first sample reservoir480from the flow channel435a. When the sample reservoir480is back in the first configuration, the piercing member455ais removed from the sample reservoir480and the seal of the sample reservoir480(e.g., a self sealing septum) fluidically isolates the first sample reservoir480from the flow channel435a. Filling the other sample reservoirs is done in a similar manner with the flow controller440being placed in the third, fourth and fifth configurations respectively.

Note that the order of fill and/or sequencing is not necessarily required (i.e., sample reservoir480does not necessarily have to be filled before sample reservoir490, etc.). Said another way, the first sample reservoir480and the second sample reservoir490(and any additional sample reservoirs) can be filled in any order. For example, the user can begin to fill the first sample reservoir480and then after the first sample reservoir480is partially filled, the user can fill the second sample reservoir490. Additionally, adjustments in the volume of the bodily-fluid collected in the sample reservoirs480and/or490can be made possible by repeated filling of the sample reservoirs480and/or490. However, in other embodiments, the order of fill can be mechanically manipulated such that the second sample reservoir cannot be accessed until a specified amount of bodily-fluid is confirmed to have been placed into the first reservoir and so on. As described above, the dial445can have a sixth position corresponding to a sixth configuration of the flow controller440that can substantially prevent fluid flow between the patient and the collection device400altogether to substantially seal the samples in the collection device400from the external environment.

Although the collection device400is shown and described above as including and/or otherwise coupling to a set of four sample reservoirs (e.g., the first sample reservoir480, the second sample reservoir480′, the third reservoir490, and the fourth reservoir490′), in other embodiments, a collection device can include and/or can be coupled to any suitable number of sample reservoirs. For exampleFIGS. 23-25illustrate a collection device500according to an embodiment. As shown, certain aspects of the collection device500can be substantially similar to corresponding aspects of the collection device500described above with reference toFIGS. 16-22. Thus, similar aspects are not described in further detail herein.

The collection device500includes a diversion mechanism520, a flow controller540, a first sample reservoir580, and a second sample reservoir590. The sample reservoirs580and590can be substantially similar to the sample reservoirs described in detail above. In some embodiments, the sample reservoirs580and590can have substantially the same shape and size and can include substantially the same culture medium. In other embodiments, the sample reservoirs580and590can have substantially the same shape and size and can include one of an aerobic culture medium or an anaerobic culture medium. In still other embodiments, the first sample reservoir580can have a first size that is substantially larger than a size of the second sample reservoir590.

As shown inFIGS. 24 and 25, the diversion mechanism520includes a housing501and a distribution member529. The housing501of the diversion mechanism520is physically and fluidically coupled to the distribution member529, and provides and/or defines a set of fluid flow pathways for collecting bodily-fluids from the patient. As described above with reference to the housing401, the housing501can defines a recess and a first outlet aperture503a, a second outlet aperture503b, and a third outlet aperture503c. The recess is configured to receive a seal member541included in the flow controller540, as described in detail above. The first outlet aperture503a, the second outlet aperture503b, and the third outlet aperture503ccan be substantially similar in form and function as the first outlet aperture403a, the second outlet aperture403b, and the third outlet aperture403c, respectively, defined by the housing401. Similarly, the distribution member529defines a pre-sample reservoir570, a first flow channel535a, and a second flow channel535bthat are substantially similar to the pre-sample reservoir470, the first flow channel435a, and the second flow channel435bincluded in the diversion member429. As such, the pre-sample reservoir570is in fluid communication with the first outlet aperture503a, the first flow channel535ais in fluid communication with the second outlet aperture503b, and the second flow channel535bis in fluid communication with the third outlet aperture503c, as described above with reference to the diversion mechanism420. As shown inFIG. 25, the distribution member529defines a first outlet port531in fluid communication with the first flow channel535aand a first piercing member555a, and a second outlet port532in fluid communication with the second flow channel535band a second piercing member555b. As described above, the piercing members555aand555bcan be used to puncture a vacuum seal of the sample reservoirs580and590which can initiate a flow of bodily-fluid, as described in further detail herein.

The flow controller540includes a dial545and a seal member541. The seal member541is disposed in the recess of the housing501, as described above. In this manner, when the flow controller540is coupled to the housing501, the seal member541forms a substantially fluid tight seal with a surface of the dial545and the surface of the housing501that defines the recess. As shown inFIGS. 24 and 25, the seal member541defines a first aperture544a, a second aperture544b, and a third aperture544cthat are substantially aligned with the first outlet aperture503a, the second outlet aperture503b, and the third outlet aperture503c, respectively, as described in detail above with reference to the seal member441.

The dial545of the flow controller540can be substantially similar in form and function as the dial445, while having a size that is suitable for coupling to the housing501. As such, the dial545can be rotatably coupled to the housing501and movable between a first position, a second position, and a third position relative to the housing501. The dial545includes an inlet port521that defines a lumen502and that can be fluidically coupled to a medical device (not shown) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device500. In this manner, the inlet port521can be configured to selectively place the pre-sample reservoir570, the first sample reservoir580, and the second sample reservoir590. More particularly, when the dial545is in the first position, the flow controller540is placed in a first configuration and the inlet port521is substantially aligned with the first aperture544aof the seal member541and the first outlet aperture503aof the housing501. In this manner, the first aperture544aof the seal member541establishes fluid communication between the inlet port521and the first outlet aperture503aand hence, places the inlet port521in fluid communication with the pre-sample reservoir570, as described in detail above with reference to the collection device400. Similarly, when the dial545is rotated (or actuated) to the second position, the flow controller540is placed in a second configuration and the second outlet aperture544bestablishes fluid communication between the inlet port521and the second outlet aperture503band hence, the first flow channel535a; and when the dial545is rotated to the third position, the flow controller540is placed in a third configuration and the third outlet aperture544cestablishes fluid communication between the inlet port521and the third outlet aperture503cand hence, the second flow channel535a. In this manner, the collection device500can be used to transfer a first volume of a bodily-fluid to the pre-sample570and subsequently used to transfer a second volume and a third volume of the bodily-fluid to the first sample reservoir580and the second sample reservoir590, respectively, as described in detail above with reference to the collection device400.

FIGS. 26-33illustrate a collection device600according to an embodiment. The collection device600includes a diversion mechanism620, a flow controller640, and sample reservoirs680,680′,690and690′. As further described herein, the collection device600can be moved between a first, a second, a third, a fourth, and a fifth configuration to deliver a flow of a bodily-fluid that is substantially free from microbes exterior the body, such as, for example, dermally residing microbes and/or other undesirable external contaminants. The collection device600can be any suitable shape, size, or configuration. For example, aspects and/or portions of the collection device600can be substantially similar in form and/or function as corresponding aspects and/or portions of any of the collection devices100,200,300,400, and/or500described above. Thus, such similar aspects and/or portions are not described in further detail herein. By way of example, in some embodiments, the sample reservoirs680,680′,690, and690′ of the collection device600can be substantially similar and/or the same in form and function as the sample reservoirs480,480′,490, and490′, respectively, included in the collection device400ofFIGS. 16-22.

The diversion mechanism620includes a distribution member629and a set of coupling members637a,637b,637c, and637d(see e.g.,FIG. 27). The distribution member629is in fluid communication with the coupling members637a,637b,637c, and637dand is configured to provide and/or define a set of fluid flow pathways for collecting bodily-fluids from the patient. As shown inFIGS. 27 and 28, the distribution member629defines and/or forms a first outlet port630in fluid communication with a pre-sample reservoir670, a second outlet port631in fluid communication with the first coupling member637a, a third outlet port632in fluid communication with the second coupling portion637b, a fourth outlet port633in fluid communication with the third coupling portion637c, and a fifth outlet port634in fluid communication with the fourth coupling portion637d.

As shown inFIG. 28, the distribution member629defines a chamber or volume that defines at least a portion of the pre-sample reservoir670. The pre-sample reservoir670is configured to contain bodily-fluids such as, for example, blood, plasma, urine, and/or the like. For example, the pre-sample reservoir670can receive and contain a first amount or volume of the bodily-fluid from the patient, where the first amount of bodily-fluid can be a predetermined or undetermined amount. Moreover, the arrangement of the diversion mechanism620and the flow controller640can be such that the pre-sample reservoir670is maintained in fluidic isolation from the coupling portions637a,637b,637c, and637dand/or subsequent volumes of bodily-fluid withdrawn from the patient, as described in further detail herein. In this manner, the outlet ports631,632,633, and634can direct and/or otherwise define a fluid flow path between the flow controller640and the coupling members637a,637b,637c, and637d, respectively, as described in further detail herein. In some embodiments, the arrangement of the first outlet port630and the pre-sample reservoir670can be substantially similar in form and function as the pre-sample reservoirs470and/or570. Thus, the pre-sample reservoir670is not described in further detail herein.

As shown inFIG. 29, the first coupling member637adefines a flow channel638athat is fluidically coupled to a piercing member655a. As described above, the coupling member637acan be physically and fluidically coupled to the distribution member629. For example, the flow channel638acan receive a portion of the second outlet port631of the distribution member to physically and fluidically couple the coupling member637athereto. In some embodiments, a surface of the second outlet port631can form a substantially fluid tight seal with an inner surface of the coupling portion637adefining the flow channel638a(e.g., a friction fit that can form a substantially hermetic seal). The piercing member655aof the coupling portion637acan be substantially similar in form and function as the piercing member455aincluded in the collection device400ofFIGS. 16-22. Thus, the piercing member655ais not described in further detail herein. The second coupling member637b, the third coupling member637c, and the fourth coupling member637dare similarly arranged. As such, the second coupling member637b, the third coupling member637c, and the fourth coupling member637deach include a piercing member655b,655c, and655d, respectively, and each define a flow channel638b,638c, and638d, respectively. As described in further detail herein, the first coupling member637a, the second coupling member637b, the third coupling member637c, and the fourth coupling member637dcan be used to selectively place the diversion mechanism620in fluid communication with the first sample reservoir680, the second sample reservoir680′, the third sample reservoir690, and the fourth sample reservoir690′, respectively.

As shown inFIGS. 30 and 31, the flow controller640includes a dial645and a seal member641. The dial645of the flow controller640is rotatably disposed within the distribution member629(see e.g.,FIGS. 32 and 33) and is movable between a first position, a second position, a third position, and a fourth position. The dial645includes an inlet port621, a first outlet port647, and a second outlet port648that are each in fluid communication with an inner volume646(see e.g.,FIG. 30). The inner volume646is configured to receive a portion of the seal member641, as described in further detail herein. The inlet port621can be fluidically coupled to a medical device (not shown) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device600. For example, the inlet port621can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) either directly or indirectly via an adapter604(see e.g.,FIGS. 26 and 27). The first outlet port647is in fluid communication with the pre-sample reservoir670. For example, the first outlet port647can be rotatably disposed in the first outlet port630of the distribution member629. The second outlet port648can be selectively placed in fluid communication with the second outlet port631, the third outlet port632, the fourth outlet port633, and the fifth outlet port634when the dial645is in its first position, second position, third position, and fourth position, respectively. In this manner, the inner volume646of the dial645can be selectively placed in fluid communication with the pre-sample reservoir670, the first sample reservoir680, the second sample reservoir680′, the third sample reservoir690, and the fourth sample reservoir690′, as described in further detail herein.

At least a portion of the seal member641of the flow controller640is rotatably disposed in the inner volume646of the dial645and movable between a first position and a second position. Moreover, the seal member641can have a size and a shape such that an outer surface of the seal member641forms a substantially fluid tight seal with an inner surface of the dial645that defines at least a portion of the inner volume646. As shown inFIG. 31, the seal member641defines a first flow channel642and a second flow channel644. When the seal member641is in its first position within the inner volume646, the first flow channel642establishes fluid communication between the inlet port621and the first outlet port647while fluidically isolating the inlet port621from the second outlet port648. Similarly, when the seal member641is in its second position within the inner volume646, the second flow channel644establishes fluid communication between the inlet port621and the second outlet port648while fluidically isolating the inlet port621from the first outlet port647. The collection device600works in a similar manner when the dial645is rotated to the second, third, and fourth positions within the distribution member629. Thus, when the inlet port621is placed in fluid communication with the patient (e.g., via the medical device coupled to the inlet port621and/or the adapter604), the first outlet port630, the second outlet port631, the third outlet port632, the fourth outlet port633, and the fifth outlet port634of the distribution member629can be selectively placed in fluid communication with the inlet port621to allow the bodily-fluid to flow into the pre-sample reservoir670, the first sample reservoir680, the second sample reservoir680′, the third sample reservoir690, and the fourth sample reservoir690′, respectively.

In operation, the collection device600can be used to collect bodily-fluids (e.g., blood, plasma, urine, and/or the like) from a patient with reduced contamination. For example, the inlet port621of the collection device600can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). Following venipuncture (or other method of accessing bodily-fluid), the seal member641can be actuated (or rotated) until in its first position, as shown inFIG. 32. Alternatively, the seal member641can be pre-set in the first position and the collection device600can be otherwise sealed to preserve the sterility of the collection device600. When the seal member641is in its first position, the flow controller640establishes fluid communication between the inlet port621and the first outlet port630of the distribution member629while fluidically isolating the inlet port621from the coupling members637a,637b,637c, and637d. Thus, as indicated by the arrow II inFIG. 32, bodily-fluid can be transferred from the patient, through the inlet port621, the first flow channel642, the first outlet port647of the dial645, and the first outlet port630of the distribution member629, and into the pre-sample reservoir670in a similar manner as described above with reference to the collection device400.

Following collection of the bodily-fluid pre-sample in the pre-sample reservoir670, the seal member641can be actuated (e.g., rotated) from its first position to its second position relative to the dial645. Similarly, the dial645can be actuated (or rotated) until it reaches the second position relative to the distribution member629, as shown inFIG. 33. When the seal member641and the dial645are in the second position, the flow controller640is placed in a second configuration and the second flow channel644of the seal member641establishes fluid communication between the inlet port621and the flow channel638aof the first coupling member637a, while fluidically isolating the pre-sample reservoir670from the inlet port621. With the flow controller640in the second configuration, the sample reservoir680can be actuated by the user (e.g., pushed against the piercing member655a) from a first configuration to a second configuration to establish fluid communication between a part of the body of a patient (e.g., a vein) and the first sample reservoir680. As described in detail above, moving the sample reservoir680to the second configuration results in the piercing member655apuncturing the vacuum seal of the sample reservoir680to be disposed inside the sample reservoir680. In this second configuration, the part of the body of a patient (e.g., a vein) is exposed to vacuum suction force from the sample reservoir680due to the negative pressure conditions (vacuum) therein. Thus, bodily-fluid can be urged to flow from the part of the body of a patient through the inlet port621, the second flow channel644, the second outlet port631, and the flow channel638aand piercing member655aof the first coupling member637a, and into the first sample reservoir680, as indicated by the arrow JJ inFIG. 33.

Once a desired volume of bodily-fluid (e.g., the second amount) is collected in the sample reservoir680, the user can actuate (rotate) the flow controller640to the third position and/or move the sample reservoir680back to its first configuration to isolate the first sample reservoir680from the second flow channel644. When the sample reservoir680is back in the first configuration, the piercing member655ais removed from the sample reservoir680and the seal of the sample reservoir680(e.g., a self sealing septum) fluidically isolates the first sample reservoir680from the flow channel635a. Filling the other sample reservoirs is done in a similar manner with the flow controller640being placed in the third, fourth and fifth configurations respectively.

FIGS. 34-40present a collection device700according to an embodiment. The collection device700includes a diversion mechanism720, a flow controller740, and sample reservoirs780and790(although there are holders present for four sample reservoirs, only two sample reservoirs are included in the figures for purposes of clarity and additional sample reservoirs (e.g. a fifth, sixth and so on) may be included as part of the collection device700). As further described herein, the collection device700can be moved between a first, a second, a third, a fourth, and a fifth configuration to deliver a flow of a bodily-fluid that is substantially free from microbes exterior to the body, such as, for example, dermally residing microbes and/or other undesirable external contaminants. The collection device700can be any suitable shape, size, or configuration. For example, aspects and/or portions of the collection device700can be substantially similar in form and/or function as corresponding aspects and/or portions of any of the collection devices100,200,300,400,500, and/or600described above. Thus, such similar aspects and/or portions are not described in further detail herein. By way of example, in some embodiments, the sample reservoirs780and790of the collection device700can be substantially similar and/or the same in form and function as the sample reservoirs480and490, respectively, included in the collection device400ofFIGS. 16-22.

The diversion mechanism720includes a housing701, a distribution member729, and a base plate771. As described above with reference to the collection device400, the housing701defines a first outlet aperture703a, a second outlet aperture703b, a third outlet aperture703c, a fourth outlet aperture703d, and a fifth outlet aperture703ethat are each configured to be in fluid communication with a different portion of the distribution member729. More specifically, the distribution member729defines and/or forms at least a portion of a pre-sample reservoir770in fluid communication with the first outlet aperture703a, and a first fluid chamber735ain fluid communication with the second outlet aperture703b, a second fluid chamber735bin fluid communication with the third outlet aperture703b, a third fluid chamber735cin fluid communication with the fourth outlet aperture703d, and a fourth fluid chamber735din fluid communication with the fifth outlet aperture703e. Furthermore, the housing701defines a recess766that is configured to movably receive at least a portion of the flow controller740, as described in further detail herein.

As shown inFIG. 36, the distribution member729defines a chamber or volume that forms at least a portion of the pre-sample reservoir770. The pre-sample reservoir770is configured to contain bodily-fluids such as, for example, blood, plasma, urine, and/or the like. The first outlet aperture703aof the housing701can be substantially aligned with an open portion of the pre-sample reservoir770to allow the pre-sample reservoir770to receive a flow of bodily-fluid from the patient, as described in detail above. Expanding further, the distribution member729includes a set of walls736that can, for example, divide an inner volume of the distribution member729into portions and/or volumes that are fluidically isolated from one another. For example, as shown inFIG. 36, the set of walls736can divide an inner volume of the distribution member729into the pre-sample reservoir770, the first fluid chambers735a, the second fluid chamber735b, the third fluid chamber735c, and the fourth fluid chamber735d. In some embodiments, the walls736can define and/or form the pre-sample reservoir770and the fluid chambers735a-735dequally. In other embodiments, the pre-sample reservoir770can have define a volume that is different from a volume defined by the fluid chambers735a-735d.

The distribution member729further includes a first piercing member755a, a second piercing member755b, a third piercing member755c, and a fourth piercing member755dthat are in fluid communication with the first fluid chamber735a, the second fluid chamber735b, the third fluid chamber735c, and the fourth fluid chamber735d, respectively. As such, the piercing members755a-355dcan be used to puncture a vacuum seal of the sample reservoirs780and790(and corresponding sample reservoirs not shown inFIGS. 34-40) which can initiate a flow of bodily-fluid, as described in further detail herein.

The flow controller740of the collection device700includes a dial745and a seal member741. The seal member741is disposed in the recess766of the housing701(see e.g.,FIGS. 38 and 40). More particularly, the flow controller740can be coupled to the housing701such that the seal member741is disposed between and in contact with a surface of the housing701defining the recess766and a surface of the dial745. The seal member741can be configured to form a substantially fluid tight seal with the surface of the dial745and the surface of the housing701that defines the recess766, as described in detail above. As shown inFIG. 35, the seal member741defines a first aperture744a, a second aperture744b, a third aperture744c, a fourth aperture744d, and a fifth aperture744e. The arrangement of the seal member741is such that when the seal member741is disposed in the recess766, the first aperture744a, the second aperture744b, the third aperture744c, the fourth aperture744d, and the fifth aperture744eare substantially aligned with the first outlet aperture703a, the second outlet aperture703b, the third outlet aperture703c, the fourth outlet aperture703d, and the fifth outlet aperture703eof the housing701, respectively.

The dial745of the flow controller740is rotatably coupled to the housing701and movable between a first position, a second position, a third position, a fourth position, and a fifth position relative to the housing701. The dial745includes an inlet port721that can be fluidically coupled to a medical device (either directly or indirectly via an adapter704) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device700. In this manner, the inlet port721can be configured to selectively place the pre-sample reservoir770, the first sample reservoir780, the second sample reservoir780′, the third sample reservoir790, and the fourth sample reservoir790′ in fluid communication with the patient, as described in further detail herein. When the dial745is in the first position, the flow controller740is placed in a first configuration and the inlet port721can be substantially aligned with the first aperture744aof the seal member741and the first outlet aperture703aof the housing701. In this manner, first aperture744aof the seal member741establishes fluid communication between the inlet port721and the first outlet aperture703awhile fluidically isolating the inlet port721from the outlet apertures703b,703c,703d, and703ewhich in turn, fluidically isolates the inlet port721from the fluid chambers735a-335d. When the dial745is rotated (or actuated) to the second position, the flow controller740is placed in a second configuration and the second outlet aperture744bestablishes fluid communication between the inlet port721and the second outlet aperture703bwhile fluidically isolating the inlet port721from the pre-sample reservoir770and the fluid chambers735b-735d. The collection device700works in a similar manner when the dial745is rotated to the third, fourth and fifth positions. Thus, when the inlet port721is placed in fluid communication with the patient (e.g., via the medical device coupled to the inlet port721), the first outlet aperture703a, the second outlet aperture703b, the third outlet aperture703c, the fourth outlet aperture703d, and the fifth outlet aperture703ecan be selectively placed in fluid communication with the inlet port721to allow all the bodily-fluid to flow into at least one of the pre-sample reservoir770, first sample reservoir780, or the second sample reservoir790(or any other fluid reservoir coupled thereto).

In some embodiments, the housing701can selectively limit movement of the dial745from its first position to its second, third, fourth, and fifth positions. In some other embodiments, the housing701can be configured to prevent movement of the dial once it has been moved to the fifth position. Said another way, the housing701can include a locking mechanism to that prevents the dial745from being moved from the fifth position back to the first position. This feature can reduce the risk of contaminating the bodily-fluid collected in the flow chambers735a-735dand/or sample reservoirs780and790from the bodily-fluid contained in the pre-sample reservoir770(which has a high risk of containing surface bound microbes and/or other undesirable external contaminants). This locking mechanism can also protect health care practitioners from exposure to blood-borne pathogens in patient samples which can include HIV, Hepatitis C, etc. The dial745and/or the housing701can also include mechanical detents and/or other indicators that provide visual or tactile feedback to ensure precise positioning of the dial745with respect to the outlet port703aand outlet apertures703a-703din the housing701.

Similar to the embodiments of the collection device400presented inFIGS. 16-22, the collection device700includes a pre-sample reservoir770that is a chamber contained within the distribution member729. The pre-sample reservoir770can contain bodily-fluids such as, for example, blood, plasma, urine, and/or the like. The pre-sample reservoir770is configured to be fluidically coupled to the first outlet port703aof the collection device700(located in the housing701). During operation of the collection device700, when the flow controller740is in the first position, bodily-fluid is drawn from a part of the body of a patient (e.g., a vein) into the pre-sample reservoir770, the aperture for the pre-sample reservoir744alocated in the seal member741, and the first outlet port703a, via the inlet port721. The pre-sample reservoir770is configured to contain the first amount of the bodily-fluid withdrawn from the patient, where the first amount of bodily-fluid can be a pre-determined or undetermined amount, such that the first amount of bodily-fluid is fluidically isolated from a second and/or third and/or fourth and/or fifth amount of the bodily-fluid that is subsequently withdrawn from the patient.

In operation, the collection device700can be used to collect bodily-fluids (e.g., blood, plasma, urine, etc.) from a patient with reduced contamination. For example, the inlet port721of the collection device700can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). Following venipuncture, the dial745is rotated until it reaches the first position, as shown inFIGS. 37 and 38. Alternatively, the dial745can be pre-set in the first position and the collection device700can be otherwise sealed to preserve the sterility of the collection device700, as described above. With the dial745in the first position, the flow controller740is placed in a first configuration and the first outlet aperture744aof the seal member741establishes fluid communication between the inlet port721and the first outlet port703a(contained within the housing701) while fluidically isolating the inlet port721from the four sample flow channels735a-735d. In this first configuration, the bodily-fluid flows from the portion of the body of the patient through the inlet port721, the first outlet aperture744aof the seal member741, the first outlet port703aof the housing701, and into the pre-sample reservoir770defined by the distribution member770, as indicated by the arrow KK inFIG. 38. Thus, a first amount (pre-determined or undetermined) of bodily-fluid can be received into the pre-sample reservoir770immediately after venipuncture and isolated from subsequent samples, as described in detail above.

Following collection of the bodily-fluid pre-sample in the pre-sample reservoir770, the dial745can be actuated (or rotated) until it reaches the second position as shown inFIGS. 39 and 40. When the dial745is in the second position, the flow controller740is placed in a second configuration and the second outlet aperture744aof the seal member741establishes fluid communication between the inlet port721and the first fluid chamber735awhile fluidically isolating the pre-sample reservoir770from the inlet port721. Once the first fluid chamber735ais filled with the bodily-fluid, the flow controller740can be moved to a third position to isolate and seal the first fluid channel735afrom an external environment. Additionally, the sample reservoir780can be actuated from the first configuration to the second configuration to transfer the bodily-fluid from the first fluid chamber735ato the sample reservoir780. For example, the sample reservoir780can be actuated (pushed against the piercing member755a) from the first configuration to the second configuration by the user, or automatically, to establish fluid communication between a part of the body of a patient (e.g., a vein) and the sample reservoir780. As described above, moving the sample reservoir780to the second configuration causes the piercing member755ato puncture the vacuum seal of the sample reservoir780, and be disposed inside the sample reservoir780. In the second configuration, the part of the body of a patient (e.g., a vein) is exposed to vacuum suction from the sample reservoir780due to the negative pressure conditions (vacuum) that in certain embodiments exist inside the sample reservoir780. Thus, bodily-fluid flows from the part of the body of the patient through the inlet port721, the second outlet aperture744bof the seal member741, the second outlet aperture703bof the housing701, the second fluid chamber735b, and into the first sample reservoir780, as indicated by the arrow LL inFIG. 40.

Once a desired volume of bodily-fluid (e.g., the second amount) is collected in the sample reservoir780, the user can actuate (rotate) the flow controller740to the third position and/or move the sample reservoir780back to its first configuration to isolate the first sample reservoir780from the inlet port721. When the sample reservoir780is back in the first configuration, the piercing member755ais removed from the sample reservoir780and the seal of the sample reservoir780(e.g., a self sealing septum) fluidically isolates the first sample reservoir780from the second fluid chamber735band the external environment. Filling the other sample reservoirs is done in an identical manner with the flow controller740in the third, fourth and fifth configurations respectively.

In some embodiments, the collection device700can be constructed such that the set of walls736separating the different fluid chambers735a-735din the distribution member729are not present (see detailed cross-sectional view inFIG. 16). In such embodiments, the distribution member729is divided between a pre-sample reservoir770and a combined fluid chamber735(i.e. the fluid chambers are not separated into four separate sections by the walls736). In such embodiments, the user can fill all four sample reservoirs at one time by actuating (rotating) the dial745to either the second, third, fourth or fifth positions.

Any of the embodiments described herein can be used with, for example, a metering device that can be used to meter (e.g., quantify) a flow of bodily-fluid into a pre-sample reservoir and/or a sample reservoir. In some instances, laboratory standard practices do not ensure consistent compliance with accurate inoculation volumes of bodily-fluids (e.g., blood specimens) due to the fact that the fill volume is visually determined by the clinician and/or phlebotomist and is thus subject to human error. The fact that the volume indicators on the blood collection bottle are difficult to read when being held and that often the collection bottle is not held upright during the draw procedure can contribute to inaccurate volumes of a bodily-fluid sample received from a patient. Insufficient sample volumes (e.g., below the manufacturer's recommendation) can decrease the sensitivity of culture tests, leading to false-negative results. Additionally, fill volumes above manufacturer's recommendations can cause false-positivity as is indicated in overview materials and instructions for use for specific types of testing supplies and apparatuses (e.g., blood culture bottles designed for use with automated microbial detection systems produced by manufacturers such as Becton Dickinson, Franklin Lakes, N.J.). Thus, flow metering and volume display features can allow a lab technician and/or a health care practitioner (e.g. phlebotomist) to confirm the volume of bodily-fluid that is collected into each individual sample reservoir before placing the sample reservoirs in an incubator or into other laboratory test equipment depending on how the sample needs to be processed. The lab technician and/or phlebotomist can also record (e.g., in a medical record, database, spreadsheet, etc.) the precise volume information for a clinician to evaluate when results are received, thereby helping reduce the possibility of misinterpretation of false-negative and/or false-positive results.

By way of example,FIGS. 41-45illustrate a collection device800that can include one or more metering devices. The collection device800includes a diversion mechanism820, a flow controller840, a display875, and a sample reservoir880. As further described herein, the collection device800can be moved between a first, a second, and a third configuration to deliver a flow of a bodily-fluid that is substantially free from microbes exterior to the body, such as, for example, dermally residing microbes and/or other undesirable external contaminants. The collection device800can be any suitable shape, size, or configuration. For example, aspects and/or portions of the collection device600can be substantially similar in form and/or function as corresponding aspects and/or portions of any of the collection devices100,200,300,400,500,600, and/or700described above. Thus, such similar aspects and/or portions are not described in further detail herein. By way of example, in some embodiments, the sample reservoir880of the collection device800can be substantially similar and/or the same in form and function as the sample reservoir480included in the collection device400ofFIGS. 16-22.

As shown inFIGS. 41-43, the diversion mechanism820includes an actuator portion822(e.g., a first portion), a medial portion823(e.g., a second portion), and a coupling portion824(e.g., a third portion). The actuator portion822of the diversion mechanism820is substantially cylindrical including a set of annular walls that define an inner volume806. More specifically, the actuator portion822includes a first end portion that is substantially closed and a second end portion, opposite the first end portion, that is substantially open to allow access to the inner volume806. In this manner, the actuator portion822can movably receive at least a portion of the flow controller840, as described in further detail herein. The actuator portion822further includes an inlet port821and an outlet port831. The inlet port821can be fluidically coupled to a medical device (either directly or indirectly via an adapter804) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device800, as described in detail above.

The outlet port831of the actuator portion822can selectively place a portion of the inner volume806of the actuator portion822in fluid communication with an inner volume807defined by the medial portion823. As shown inFIG. 43, the medial portion823is disposed between the actuator portion822and the coupling portion824. Although not shown inFIGS. 41-45the medial portion823can include a metering device that can be configured to meter a volume of bodily-fluid that is transferred, for example, to the sample reservoir880. For example, in some embodiments, the flow metering device can be fluidically coupled to the outlet port831to meter a flow of bodily-fluid therethrough. As shown inFIGS. 41 and 42, the medial portion823includes a display875that can provide, to a user, a visual indicator and/or information that is associated with, for example, a volume of bodily-fluid that has flowed through the outlet port831. In other embodiments, the flow metering device can be positioned at any other suitable position in or along the diversion mechanism820.

The coupling portion824can be physically and fluidically coupled to the medial portion823. For example, in some embodiments, the coupling portion824can be partially disposed in the inner volume807of the medial portion823and at least temporarily coupled thereto via a friction fit, a press fit, a snap fit, a threaded coupling, an adhesive, and/or the like. The coupling portion824is configured to receive a portion of the sample reservoir880and includes a piercing member855that can be used to puncture a vacuum seal of the sample reservoir880which can initiate a flow of bodily-fluid, as described in detail above.

The flow controller840of the collection device800is at least partially disposed in the inner volume806defined by the actuator portion822and is movable between a first configuration, a second configuration, and a third configuration. As shown inFIGS. 42 and 43, the flow controller840includes a movable member850having a first seal member861, a second seal member862, and a third seal member863, and a bias member859(e.g., a spring or the like). The seal members861,862, and863are in contact with an inner surface of the actuator portion822that defines the inner volume806. As such the seal members861,862, and863can each form a substantially fluid tight seal with the inner surface that can, for example, divide the inner volume806of the actuator portion822into fluidically isolated portions, as described in further detail herein.

The movable member850is movable within the inner volume806between a first position, a second position, and a third position. The arrangement of the movable member850can be such that as the movable member850is moved between its first, second, and third positions, the seal members861,862, and863are selectively moved within the inner volume806. More specifically, the first seal member861can be moved concurrently with the movable member850as the movable member850is moved between its first position, second position, and third position. The second seal member862and the third seal member863can be fixedly coupled to each other (e.g., disposed at a fixed distance from each other) and slidably disposed about a portion of the movable member850which can allow the movable member850to move from its first position (see e.g.,FIG. 43) to its second position (see e.g.,FIG. 44), while the second seal member862and the third seal member863remain in a substantially fixed position relative to the actuator portion822. For example, the second seal member862and the third seal member863can remain in a substantially fixed position as the movable member850is moved between its first position and the second position such that the inlet port821is disposed on a first side of the second seal member862, while the outlet port831is disposed on a second side, opposite the first side, of the second seal member862. Thus, when the movable member850is in its first position (FIG. 43) and its second position (FIG. 44), the inlet port821is in fluid communication with a portion of the inner volume806defined between a first seal member861and the second seal member862and the outlet port is in fluid communication with the a portion of the inner volume806defined between the second seal member862and the third seal member863, as described in further detail herein.

The arrangement of the flow controller840can be such that the first seal member861is moved relative to the second seal member862and the third seal member863when the movable member850is moved from its first position to its second position. The movement of the first seal member861relative to the second seal member862can be such that a space defined therebetween is increased, which can form and/or otherwise define a pre-sample reservoir870. Moreover, with the seal members861and862forming substantially fluid tight seals with the inner surface of the actuator portion822, the pre-sample reservoir870defined between the first seal member861and the second seal member862is fluidically isolated from other portions of the inner volume806. Thus, the inlet port821can be in fluid communication with the pre-sample reservoir870when the movable member850is moved from its first position to its second position. When the movable member850is moved from its second position (see e.g.,FIG. 44) to its third position (see e.g.,FIG. 45), a portion of the movable member850can contact the third seal member863to move the first seal member861, the second seal member862, and the third seal member863substantially concurrently within the inner volume806. As such, the second seal member862can be moved relative to the inlet port821such that both the inlet port821and the outlet port831are in fluid communication with the portion of the inner volume806defined between the second seal member862and the third seal member863, as described in further detail herein.

In operation, the collection device800can be used to collect bodily-fluids (e.g., blood, plasma, urine, etc.) from a patient with reduced contamination. For example, the inlet port821of the collection device800can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). With the inlet port821coupled to the lumen-defining device, the flow controller840can be moved from its first configuration to its second configuration. In this manner, a user can exert a force to move the movable member850from its first position to its second position, as indicated by the arrow MM inFIG. 44. As described above, the first seal member861is moved concurrently with the movable member850such that a space defined between the first seal member861and the second seal member862is increased, thereby forming and/or defining the pre-sample reservoir870. With the first seal member861and the second seal member862forming a substantially fluid tight seal with the inner surface of the actuator portion822that defines the inner volume806, the increase in volume between the first seal member861and the second seal member862produces a negative pressure in the pre-sample reservoir870. Thus, once fluid communication is established between a portion of the body of the patient (e.g., a vein) and the pre-sample reservoir870(e.g., via the inlet port821inFIG. 44), the negative pressure differential between the pre-sample reservoir870and the portion of the body of the patient draws the bodily-fluid through the inlet port821and into the pre-sample reservoir870, as indicated by the arrow NN inFIG. 44. In this first configuration, the flow controller840also fluidically isolates the pre-sample reservoir870from the outlet port831. Therefore, a first amount (predetermined or undetermined) of bodily-fluid can be received into the pre-sample reservoir870immediately after venipuncture (for example) and isolated from subsequent samples. In this manner, the collection device800can be used to prevent the first amount of bodily-fluid, which is most likely to contain bodily surface microbes and/or other undesirable external contaminants, from contaminating subsequent amounts of the bodily-fluid samples that are collected and used for diagnostic or other testing that can be impacted by the contaminants. In some embodiments, the metering device can meter the volume of bodily-fluid disposed in the pre-sample reservoir870and present a value associated with the volume on the display875.

Following collection of the volume of bodily-fluid pre-sample in the pre-sample reservoir870, the movable member850can be moved from its second position to its third position to place the flow controller in its third configuration, as indicated by the arrow OO inFIG. 45. As described above, when the movable member850is moved from its second position to its third position, the portion of the movable member850is placed in contact with the third seal member863. Thus, the movable member850moves the first seal member861, the second seal member862, and the third seal member863substantially concurrently within the inner volume806. As such, the second seal member862can be moved relative to the inlet port821such that both the inlet port821and the outlet port831are in fluid communication with the portion of the inner volume806defined between the second seal member862and the third seal member863. Moreover, with the volume of bodily-fluid fluidically isolated in the pre-sample reservoir870, movement of the second seal member862and the third seal member863in the direction of the first seal member861is limited (i.e., the bodily-fluid is a substantially incompressible fluid). In this manner, the pre-sample volume of bodily-fluid is sequestered in the pre-sample reservoir870and the space defined between the second seal member862and the third seal member863defines a fluid flow path between the inlet port821and the outlet port831. In addition, the arrangement of the flow controller840is such that when in its third configuration, the first seal member861is placed in contact with the bias member859and at least a portion of a force exerted by a user on the movable member850is operable in deforming, compressing, bending, and/or otherwise reconfiguring the bias member859. Thus, the bias member859can exert a reaction force on the first seal member861that resists the movement of the flow controller840from its second configuration to its third configuration, as described in further detail herein.

The sample reservoir880can be positioned relative to the collection device800such that the piercing member855punctures the vacuum seal of the sample reservoir880to be disposed inside the sample reservoir, as described in detail above. The pressure differential between the sample reservoir880(e.g., vacuum or negative pressure) and the portion of the body draws the bodily-fluid into the sample reservoir880. Said another way, in the second configuration, the flow controller840and the diversion mechanism820establish a fluid flow path such that bodily-fluid can drawn from the patient, through the inlet port821, the portion of the inner volume806defined between the second seal member862and the third seal member863, and the outlet port831of the actuator portion822, through the medial portion823and the piercing member855of the coupling portion824and into the sample reservoir880as indicated by the arrow PP inFIG. 45. As described above, the metering device (not shown) can meter the volume of bodily-fluid transferred through, for example, the outlet port831and can present a value associated with the volume of the bodily-fluid on the display875.

Once a desired volume of bodily-fluid (e.g., the second amount) is collected in the sample reservoir880, the user can remove and/or decrease the force exerted on the movable member850, thereby allowing the bias member859to move the first seal member861and the movable member850from their third positions towards their second positions. Moreover, with the bodily-fluid disposed in the pre-sample reservoir870being substantially incompressible, the movement of the first seal member861transfers a force through the volume of bodily-fluid to move the second seal member862and the third seal member863from their third positions towards their second positions. In some embodiments, the bias member859can exert a force on the first seal member861that can be operable in moving the second seal member862to a fourth position relative to the actuator portion822that can, for example, substantially obstruct the inlet port821. Thus, the inlet port821can be fluidically isolated from the inner volume806of the actuator portion822. Furthermore, the piercing member855can be removed from the sample reservoir880and a seal (e.g., a self sealing septum) can fluidically isolate the bodily-fluid sample from a volume outside of the sample reservoir880. Filling subsequent sample reservoirs can be similarly performed by disposing the piercing member855into a sample reservoir and moving the flow controller840to the third configuration to allow a flow of bodily-fluid from the patient to the sample reservoir.

FIGS. 46-53illustrate a collection device900according to an embodiment. The collection device900includes a diversion mechanism920, a flow controller940, and sample reservoirs980,980′,990and990′. As further described herein, the collection device900can be moved between a first, a second, a third, a fourth, and a fifth configuration to deliver a flow of a bodily-fluid that is substantially free from microbes exterior the body, such as, for example, dermally residing microbes and/or other undesirable external contaminants. The collection device900can be any suitable shape, size, or configuration. For example, aspects and/or portions of the collection device900can be substantially similar in form and/or function as corresponding aspects and/or portions of any of the collection devices100,200,300,400,500,600,700, and/or800described above. Thus, such similar aspects and/or portions are not described in further detail herein. By way of example, in some embodiments, the sample reservoirs980,980′,990, and990′ of the collection device900can be substantially similar and/or the same in form and function as the sample reservoirs680,680′,690, and690′, respectively, included in the collection device600ofFIGS. 26-33.

The diversion mechanism920includes a housing901, a distribution member929, and movable members950a,950b,950c, and950d. The housing901is physically and fluidically coupled to the distribution member929, and provides and/or defines a set of fluid flow pathways for collecting bodily-fluids from the patient. The housing901includes a set of displays975′ (e.g., liquid crystal displays (LCDs) or the like) that can be included in and/or otherwise coupled (e.g., electrically and/or mechanically) to a flow metering device, as described in further detail herein. The housing901defines a recess966, outlet apertures903a,903b,903c,903d,903e, and movable member openings950a,950b,950c,950d(also referred to herein as “openings”). The recess966is configured to receive a seal member941included in the flow controller940, as described in further detail herein. The first outlet aperture903a, the second outlet aperture903b, the third outlet aperture903c, the fourth outlet aperture903d, and the fifth outlet aperture903eare each configured to define a different fluid flow path in fluid communication with different portions of the distribution member929. More specifically, the distribution member929defines and/or forms at least a portion of a pre-sample reservoir970in fluid communication with the first outlet aperture903a, and a first flow channel935ain fluid communication with the second outlet aperture903b, second flow channel935bin fluid communication with the third outlet aperture903b, a third flow channel935cin fluid communication with the fourth outlet aperture903d, and a fourth flow channel935in fluid communication with the fifth outlet aperture903e.

As shown inFIGS. 47 and 48, the distribution member929defines a chamber or volume that defines at least a portion of the pre-sample reservoir970. The pre-sample reservoir970is configured to contain bodily-fluids such as, for example, blood, plasma, urine, and/or the like. The first outlet aperture903aof the housing901can be substantially aligned with an open portion of the pre-sample reservoir970to allow the pre-sample reservoir970to receive a flow of bodily-fluid from the patient, as described in detail above with reference to the pre-sample reservoir470inFIGS. 16-22. The flow channels935a-935dextend radially from a center of the distribution member929and are arranged such that each flow channel935a,935b,935c, and935dis fluidically isolated from the pre-sample reservoir970and the other flow channels. In this manner, the flow channels935a,935b,935c, and935dcan direct and/or otherwise define a fluid flow path between a first end portion that defines an opening substantially aligned with the outlet apertures903b,903c,903d, and903e, respectively, and a second end portion that defines an opening or port configured to receive the movable members950a,950b,950c, and950d, respectively. Although the distribution member929is shown inFIGS. 47 and 48as including flow channels935a-935dthat are substantially closed, in other embodiments, the flow channels935a-935dcan be substantially open as shown and described above with reference to the distribution member429ofFIGS. 17 and 18. As such, the distribution member929of the collection device900can function in a substantially similar manner as the distribution member429of the collection device400.

The movable members950a,950b,950c, and950dare movably disposed in the openings905a,905b,905c, and905d, respectively, of the housing901and the corresponding openings defined by the second end portion of the distribution member929. Although not shown inFIGS. 46-53, in some embodiments, the movable members950a,950b,950c, and950dcan be operably coupled to a bias member or the like, as described in detail above with reference to the movable members250and250′ of the collection device200. In this manner, the movable members950a,950b,950c, and950dcan be actuated (e.g., moved) by the user from a first position and a second position relative to the housing901and distribution member929to direct fluid flow into the first sample reservoir980, the second fluid reservoir980′, the third fluid reservoir990, and the fourth sample reservoir990′, respectively. The movable members950a,950b,950c, and950dare substantially the same and therefore are described with reference to a single movable member950inFIG. 49. Moreover, portions of the movable member950can be substantially similar to the movable members250and350described above. Thus, portions of the movable member950are not described in further detail herein. The movable member950defines an inner cavity952that is in fluid communication with an inlet port953and a piercing member955. The piercing member is substantially similar to those described in detail above. The inlet port953extends through a set of walls that defines the inner chamber952to selectively place the inner volume952of the movable member950in fluid communication with the corresponding flow channel935a,935b,935c, or935d.

As shown inFIG. 49, the movable member950includes a flow control mechanism967rotatably disposed in the inner volume952and in substantially direct fluid communication with the inlet port953. The flow metering mechanism967can be, for example, a wheel or the like that can include a set of spokes or fins. In this manner, bodily-fluid can enter the inlet port953of the movable member950and flow past the flow metering device967, which in turn, can result in a rotation of the flow metering device967relative to the movable member950. Thus, characteristics of the rotation of the flow metering device967can be operable in determining a volume of bodily-fluid transferred to the inner volume952of the movable member950, a volumetric flow rate, and/or the like. Although not shown inFIGS. 46-53, the flow control mechanism967of the movable member950is operably coupled to the display975′ of the housing901. Thus, as bodily-fluid is transferred, for example, to the sample reservoirs980,980′,990, and/or990′, volumetric information associated with the flow of bodily-fluid can be presented on the displays975′. In this manner, a user can manipulate the collection device900to collect a bodily-fluid sample from a patient and can visualize at least one of the displays975′ to determine a precise volume of the bodily-fluid sample transferred to, for example, the sample reservoir980.

The flow controller940of the collection device900includes a dial945and a seal member941. The seal member941is disposed in the recess966of the housing901. More particularly, the flow controller940can be coupled to the housing901such that the seal member941is disposed between and in contact with a surface of the housing901defining the recess966and a surface of the dial945. The seal member941can be configured to form a substantially fluid tight seal with the surface of the dial945and the surface of the housing901that defines the recess966, as described in detail above. As shown inFIG. 47, the seal member941defines a first aperture944a, a second aperture944b, a third aperture944c, a fourth aperture944d, and a fifth aperture944e. The arrangement of the seal member941is such that when the seal member941is disposed in the recess966, the first aperture944a, the second aperture944b, the third aperture944c, the fourth aperture944d, and the fifth aperture944eare substantially aligned with the first outlet aperture903a, the second outlet aperture903b, the third outlet aperture903c, the fourth outlet aperture903d, and the fifth outlet aperture903eof the housing901, respectively.

The dial945of the flow controller940is rotatably coupled to the housing901and movable between a first position, a second position, a third position, a fourth position, and a fifth position relative to the housing901. The dial945includes an inlet port921that can be fluidically coupled to a medical device (either directly or indirectly via an adapter904) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device900. In this manner, the inlet port921can be configured to selectively place the pre-sample reservoir970, the first sample reservoir980, the second sample reservoir980′, the third sample reservoir990, and the fourth sample reservoir990′ in fluid communication with the patient, as described in further detail herein. The dial945can be configured to rotate through the first position, the second position, the third position, the fourth position, and the fifth position in a substantially similar manner as described above with reference to the dial445of the collection device400and is therefore, not described in further detail herein.

As shown, the dial945can further include a display975that can be configured to present volumetric information associated with a flow of bodily-fluid. For example, although not shown inFIGS. 46-53, the dial can include a flow metering device or the like such as the flow metering device967included in the movable member950. In this manner, the flow metering device can meter a flow of bodily-fluid through, for example, the inlet port921and can be operably coupled to the display975such that volumetric information associated with the flow of bodily-fluid through the inlet port921is presented on the display975of the dial945.

In operation, the collection device900can be used to collect bodily-fluids (e.g., blood, plasma, urine, and/or the like) from a patient with reduced contamination. For example, the inlet port921of the collection device900can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). Following venipuncture (or other method of accessing bodily-fluid), the dial945is actuated (or rotated) until it reaches the first position, as shown inFIGS. 50 and 51. Alternatively, the dial945can be pre-set in the first position and the collection device900can be otherwise sealed to preserve the sterility of the collection device900.

As described above, when the dial945is in the first position, the flow controller940is placed in the first configuration and the first aperture944aof the seal member941establishes fluid communication between the inlet port921and the first outlet port930(contained within the housing901) while fluidically isolating the inlet port921from the four flow channels935a-335d. Additionally, the sample reservoirs980,980′,990and990′ are fluidically isolated from the inlet port921in the first configuration and a fluid flow path is defined between a portion of the body of a patient (e.g. a vein) and the pre-sample reservoir970as indicated by the arrow QQ inFIG. 51. In this first configuration, the bodily-fluid flows (e.g., by gravitation force, vacuum, etc.) from the portion of the body of the patient through the inlet port921, the first aperture944aof the seal member941, the first outlet port903aof the housing901, and into the pre-sample reservoir970. In the first configuration, the flow controller940also fluidically isolates the pre-sample reservoir970from the flow channels935a-935d. Thus, a first amount (predetermined or undetermined) of bodily-fluid can be received into the pre-sample reservoir970immediately after venipuncture and isolated from subsequent samples. In this manner, the collection device900can be used to prevent the first amount of bodily-fluid, which is most likely to contain bodily surface microbes and/or other undesirable external contaminants, from contaminating subsequent amounts of the bodily-fluid samples that are collected and used for diagnostic or other testing that can be impacted by the contaminants. Moreover, the display975can present, for example, information received from the flow control mechanism (not shown) that is associated with a volume of bodily-fluid transferred to the pre-sample reservoir970. Thus, a precise volume of bodily-fluid can be transferred to and fluidically isolated within the pre-sample reservoir.

Following collection of the bodily-fluid pre-sample in the pre-sample reservoir970, the dial945can be actuated (or rotated) until it reaches the second position as shown inFIGS. 52 and 53. When the dial945is in the second position, the flow controller940is placed in the second configuration and the second aperture944bof the seal member941establishes fluid communication between the inlet port921and the flow channel935a, while fluidically isolating the pre-sample reservoir970from the inlet port921. With the flow controller940in the second configuration, the movable member950acan be actuated (i.e., depressed) from the first position to the second position by the user to establish fluid communication between the patient (e.g., a vein) and the first sample reservoir880. More specifically, the movable member950is moved from its first position to its second configuration to pass the piercing member955through a vacuum seal of the first sample reservoir980to be disposed therein, as indicated by the arrow RR inFIG. 53.

While in the second position, the inlet port953of the movable member950is substantially aligned with, and in fluid communication with, the first flow channel935a, which allows the bodily-fluid to flow from the first flow channel935a, into the inner cavity952of the movable member950, and out of the piercing member955into the first sample reservoir980. The pressure differential between the sample reservoir980(e.g., vacuum or negative pressure) and the first flow channel935adraws the bodily-fluid into the sample reservoir980. Said another way, in the second configuration, the flow controller940and the movable member950aestablish a fluid flow path between the inlet port921of the dial945and the first sample reservoir980, as indicated by the arrow SS inFIG. 53. Moreover, the flow of bodily-fluid through the movable member950arotates the flow metering mechanism967relative to the movable member950. Thus, the rotation of the flow metering mechanism967can be operable in determining a volume of bodily-fluid sample transferred to the sample reservoir980. In addition, the display975′ can present, for example, information received from the flow control mechanism967that is associated with a volume of bodily-fluid transferred to the sample reservoir980. Therefore, a precise volume of bodily-fluid can be transferred to the sample reservoir980. For example, in some instances, the collection device900can be used to collect three sample volumes of 20 mL each in the first sample reservoir980, the second sample reservoir980′, and the third sample reservoir990(i.e., 60 mL of total sample volume collected).

Once a desired volume of bodily-fluid (e.g., the second amount) is collected in the first sample reservoir980, the user can release the movable member950allowing the bias member (not shown) to move the back to its first position. With the movable member950back in its first position, the piercing member955is removed from the first sample reservoir980and the seal (e.g., a self sealing septum) fluidically isolates the first sample reservoir980from the inner flow channel935. The collection device900can be used to transfer a second sample volume to the second sample reservoir980′, a third sample volume to the third sample reservoir990, and a fourth sample volume to the fourth sample reservoir990′ in the same manner by rotating the dial945to its third position, fourth position, and fifth position, respectively.

In some instances, the bodily-fluid collection device900can allow a clinician and/or a phlebotomist to open the package containing the bodily-fluid collection device900and remove only the housing901(that contains the distribution member929) and take the housing901to a patient's bedside. The clinician and/or a phlebotomist can perform venipuncture (or employ any other method of accessing patient's bodily-fluid) on the portion of the body of a patient (e.g. a vein) using any standardized technique. Following venipuncture, the clinician and/or a phlebotomist can collect the total blood volume required for all samples. For example, the clinician and/or a phlebotomist can collect a 2.5 mL pre-sample diversion volume and a 10 mL sample volume for each of the four sample reservoirs that amounts to a total of 42.5 mL of collected bodily-fluid (e.g., blood). Following collection of the desired amount of bodily-fluid, the hypodermic needle can be removed from the portion of the body of a patient (e.g. a vein) and the clinician and/or a phlebotomist can place the housing901(that contains the bodily-fluid) on top of a 4-pack (or 2-pack) of pre-sterilized sample reservoirs with septum tops that are pre-positioned in a custom tray that matches the geometry of housing901. By using such a pre-sterilized pack of sample reservoirs, the clinician does not need to perform the process step of “wiping” the top of the sample reservoirs with a sterilizing agent, thereby reducing the likelihood of contamination if, for example, the reservoir tops are improperly and/or insufficiently sterilized. The clinician and/or a phlebotomist can then activate the automated inoculation of the sample reservoirs with the bodily-fluid with precise volume control. In certain embodiments, after the inoculation of the sample reservoirs is complete, the entire device900with volume information displayed for each individual sample reservoir can be sent to the laboratory for analysis. It other embodiments, sample reservoirs980and/or990can be removed individually and sent to the laboratory for analysis.

Although, the collection device900is shown and described with reference toFIGS. 46-53as including a set of displays975and975′ that can present volumetric data associated with a volume of bodily-fluid transferred through a portion of the collection device, in other embodiments, a collection device can include any suitable flow metering mechanism having any suitable output indicator. For example,FIGS. 54 and 55illustrate a diversion mechanism1020and a flow controller1040according to an embodiment. The diversion mechanism1020and the flow controller1040can be substantially similar in form and function as the diversion mechanism920and the flow controller940, respectively. Therefore, similar portions are not described in further detail herein. The diversion mechanism1020and the flow controller1040can differ, however, in the arrangement of a set of displays1075. For example, the diversion mechanism1020includes a housing1001that is configured to movably receive a set of movable members1050a,1050b,1050c, and1050dthat can each include a flow metering mechanism as described above with reference to the movable member950. Thus, the movable members1050a,1050b,1050c, and1050dcan be used to determine a precise volume of bodily-fluid transferred therethrough. As shown inFIG. 55, the displays1075of the housing1001can include a set of three lights with a first light with low volume (e.g., 5 mL), a second light associated with medium volume (e.g., 20 mL), and a third light associated with acceptable and/or high volume (e.g., 40 mL). In this manner, as a flow of bodily-fluid is transferred through the flow controller1040and the diversion mechanism1020, and into, for example, the first movable member1050a, the flow metering mechanism included therein can send a signal or the like to the display that is operable in lighting the first light, the second light, and/or the third light according to a volume of bodily-fluid that is transferred through the movable member1050.

In other embodiments, the movable members1050a,1050b,1050c, and1050dcan be moved from a first position to a second, third, or fourth position, relative to the housing1001. In such embodiments, the positions can be associated with, for example, an intended volume of bodily-fluid to be transferred to a sample reservoir. For example, in some embodiments, a user can actuate (e.g., move) the movable member1050afrom its first position to its second position. In such embodiments, the second position can be associated with, for example, a low volume of bodily-fluid (e.g., 10 mL) to be transferred to a sample reservoir. In some embodiments, the housing1001and/or the movable member1050acan include a detent, lock, catch, protrusion, recess, and/or the like that can temporarily retain the movable member1050ain the second position until the low volume amount of sample has been transferred to the sample reservoir. Moreover, once placed in the second position, the display1075can be configured to illuminate the first light associated with the low volume to indicate to the user the preset volume of bodily-fluid to be transferred to the sample reservoir. Once the desired volume of bodily fluid is transferred to and fluidically isolated in the sample reservoir, the diversion mechanism1020can be configured to automatically return the movable member1050aback to its first position. In this manner, the diversion mechanism1020and the flow controller1040can be physically and fluidically coupled to any number of sample reservoirs and used to transferred a precise volume of bodily-fluid to each sample reservoir.

FIG. 56is a flowchart illustrating a method1190of using a flow-metering transfer device to obtain a predetermined sample volume of a bodily-fluid from a patient. The flow metering transfer device can be any of the transfer devices (also referred to herein as “collection devices”) described herein. By way of example, in some embodiments, the transfer device can be the collection device900described above with reference toFIGS. 46-53. As such, the transfer device can include a diversion mechanism with an inlet port configured to be selectively placed in fluid communication with the patient, a pre-sample reservoir and a sample reservoir, and a flow-metering mechanism configured to meter a flow of bodily-fluid from the patient to the pre-sample reservoir and to the sample reservoir. The method1190includes establishing fluid communication between the patient and the port of the flow-metering transfer device, at1191. For example, the port can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing), which in turn can be inserted into the patient (e.g., a venipuncture event or other method of accessing bodily-fluid).

With the port in fluid communication with the patient, fluid communication between the port and the pre-sample reservoir is established, at1192. In some embodiments, the flow-metering transfer device can include a flow controller or the like (e.g., such as the flow controller940included in the collection device900) that can be actuated and/or manipulated (e.g., rotated) to a position that establishes fluid communication between the port and the pre-sample reservoir (e.g., a first position). In some embodiments, the actuating of the flow controller can be such that the flow controller and the diversion mechanism collectively define at least a portion of a fluid flow path between the port and the pre-sample reservoir. In some embodiments, the pre-sample reservoir can include a negative pressure or the like that can, for example, initiate a flow of bodily-fluid from the patient to the pre-sample reservoir. In other embodiments the flow of bodily-fluid can be initiated in any other suitable manner (e.g., gravity or the like).

The flow of bodily-fluid transferred from the patient to the pre-sample reservoir is metered, at1193. For example, in some embodiments, the port can include the flow control mechanism which can be meter a flow of bodily-fluid that passes through the port (e.g., in a similar manner as described above with reference to the flow control mechanism967of the collection device900). Thus, a pre-sample volume of bodily-fluid is transferred to the pre-sample reservoir. The method1190includes verifying the pre-sample volume of bodily-fluid disposed in the pre-sample reservoir is a predetermined pre-sample volume of bodily-fluid via the flow metering mechanism of the flow-metering transfer device, at1194. For example, the flow metering mechanism can include and/or can be operably coupled to a display of the like (e.g., the display975and/or975′ of the collection device900). The flow metering mechanism can be configured to present on the display volumetric information, as described above.

Once the pre-sample volume of bodily-fluid is disposed in the pre-sample reservoir, the pre-sample reservoir is fluidically isolated from the port to sequester the pre-sample volume of bodily-fluid in the pre-sample reservoir, at1195. For example, in some instances, the flow controller and/or the diversion mechanism can be actuated (or rotated) from the first position and/or configuration to a second position and/or configuration. With the flow controller and/or diversion mechanism in the second configuration, the pre-sample reservoir is fluidically isolated from a volume outside of the pre-sample reservoir. In some embodiments, when the flow controller and/or diversion mechanism is actuated to its second position and/or configuration, fluid communication is established between the port and a sample reservoir, at1196. For example, in some embodiments, the flow-metering transfer device can include a movable member (e.g., the movable member950) or the like that can include a piercing member configured to pierce a portion of the sample reservoir (e.g., a septum or the like). Therefore, with the flow controller and/or diversion mechanism in its second position and/or configuration, the piercing of the portion of the sample reservoir places the sample reservoir in fluid communication with the port. As described above, the sample reservoir can include a negative pressure or the like that can, for example, initiate a flow of bodily-fluid from the patient to the sample reservoir.

The flow of bodily-fluid transferred from the patient to the pre-sample reservoir is metered, at1197. For example, as described above, the port can include the flow control mechanism which can be meter a flow of bodily-fluid that passes through the port (e.g., in a similar manner as described above with reference to the flow control mechanism967of the collection device900). In some embodiments, the flow control mechanism can be included in, for example, a movable member or the like such as the movable member950ofFIG. 49. Thus, a sample volume of bodily-fluid is transferred to the sample reservoir. The method1190includes verifying the sample volume of bodily-fluid disposed in the sample reservoir is a predetermined sample volume of bodily-fluid via the flow metering mechanism of the flow-metering transfer device, at1198. For example, the display or the like can be configured to present volumetric information, as described above.

In this manner, the predetermined pre-sample volume of bodily-fluid is collected that can contain, for example, externally residing microbes. For example, in some embodiments, the predetermined pre-sample volume can 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 10.0 mL, about 20 mL, about 50 mL, and/or any volume or fraction of a volume therebetween. In other embodiments, the pre-sample volume can be greater than 50 mL or less than 0.1 mL. In other embodiments, the predetermined pre-sample volume can be between about 2 mL and about 5 mL. In one embodiment, the predetermined pre-sample volume can be about 3 mL. Furthermore, by collecting the predetermined pre-sample volume, the predetermined sample volume disposed in one or more sample reservoirs can be substantially free-from externally residing microbes. In some embodiments, the predetermined sample volume can be between 10 mL and 60 mL. In other embodiments, the predetermined sample volume can be between 30 mL and 60 mL. In still other embodiments, the predetermined sample volume can be 60 mL. Although described above as transferring the sample volume of the bodily-fluid to a single sample reservoir, in other embodiments, the flow-metering transfer device can be used to transfer a predetermined sample volume to more than one sample reservoir. For example, in some embodiments, a pre-determined pre-sample volume of bodily-fluid can be collected and fluidically isolated in a pre-sample reservoir, as described above. With the pre-sample volume fluidically isolated, the flow-metering transfer device can be used to transfer a predetermined sample volume to a first sample reservoir, the predetermined sample volume to a second sample reservoir, and the predetermined sample volume to a third sample reservoir. In such instances, the predetermined sample volume can be, for example, 20 mL such that a total sample volume disposed in the first, second, and third sample reservoirs is 60 mL.

The various embodiments of the bodily-fluid collection devices described herein can allow the collection of two (or more) sets of bodily-fluids (e.g., blood) samples from a single venipuncture. The current standard of care dictates that certain tests (e.g. blood cultures) be conducted with samples procured from distinct, separate bodily-fluid access points (e.g. via two separate venipunctures, via a catheter+a venipuncture and/or any combination thereof). Embodiments described herein can facilitate the procurement of multiple samples for specific diagnostic testing (e.g. blood culture test) from a single bodily-fluid access point (e.g. venipuncture), which can reduce the annual number of venipunctures required for procurement of these samples by a factor of 2. This benefits both patients and health care practitioners alike. A reduction in the number of venipunctures (and/or other bodily-fluid access procedures) can significantly reduce the risk of needle stick injury to heath care practitioners and reduce patient associated complications which result from these procedures (e.g. hematoma, thrombosis, phlebitis, infection, etc.). Additionally, reducing the number of bodily-fluid access procedures (e.g. venipunctures) reduces the utilization of supplies, labor and waste associated with these procedures. The decreased costs realized by the healthcare system are material and represent an opportunity to drive more efficient consumption of resources as well as enhanced patient outcomes due to improved sample integrity which results in more accurate patient diagnoses which inform development and implementation of treatment plan(s). The bodily-fluid collection devices also significantly reduce the occurrence of false-positives from post-collection analysis. The bodily-fluid collection devices described herein can also streamline the bodily-fluid collection process and reduce the number of manual steps and “touch points”, thereby decreasing opportunities for external contamination. The devices described herein can also minimize the risk for needle stick injuries and infection for the lab technicians and/or phlebotomists.

In some embodiments, the bodily-fluid collection devices described herein (e.g.,100,200,300,400,500,600,700,800, and900) can include and/or be partially formed from antisepsis saturated materials (e.g., housing401). Current standards rely on health care practitioners placing individual antisepsis materials (e.g. isopropyl alcohol swabs) on the top of individual sample reservoirs (e.g.,480,480′,490, and490′). To ensure compliance with this protocol, the device400(for example) can include antisepsis materials positioned in the device400such that when the housing401is placed on top of the 4-pack (or 2-pack) of bottles as illustrated inFIG. 16, the first point of contact from the hosing401and the tops of the sample reservoirs480,480′,490,490′ is the antisepsis material. In this manner, the tops of the sample reservoirs480,480′,490,490′ are assured to have an appropriate antisepsis applied prior to inoculation of the bodily-fluid into the sample reservoirs.

While various embodiments have been particularly shown and described, various changes in form and details may be made. For example, while the dial445(actuator) is shown and described with respect toFIGS. 19-22as being rotated in a single direction, in other embodiments, the dial445(actuator) can be rotated in a first direction and a second direction, opposite the first. In such embodiments, the rotation in the second direction can be configured to move a collection device through any number of configurations. In other embodiments, the rotation of the actuator in the second direction can be limited. In some embodiments, the dial can include a mechanical stop or lock to fluidically isolate the first volume of bodily-fluid received from the patient (i.e., the contaminated sample). Said another way, once the first reservoir (pre-sample reservoir) is filed with a predetermined volume of bodily-fluid and the user has rotated the dial (actuator) to begin drawing additional sample, the dial (actuator) cannot be moved back to establish fluid communication with the first sample volume (contained in the pre-sample reservoir).

While embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having any combination or sub-combination of any features and/or components from any of the embodiments described herein. For example, while the collection device700is shown and described with respect toFIGS. 34-40as having a first, second, third, fourth, or fifth configuration, in other embodiments, the collection devices described herein may have more or fewer configurations. In addition, while the collection device200is shown and described with respect to inFIGS. 2-13as having a vacuum based collection tube as the pre-sample reservoir270, in other embodiments, the collection device200can have a chamber contained within the housing201similar to the collection device400of the embodiment presented inFIGS. 16-22, which includes a pre-sample reservoir470that is a chamber contained within the distribution member429, and vice versa.

The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different than the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired rate of bodily-fluid flow into a fluid reservoir. Furthermore, while the flow metering mechanism967is particularly shown inFIG. 49, any of the collection devices described herein can be used with any suitable flow metering mechanism. For example, in some embodiments, a collection device can include a flow metering mechanism and/or any other mechanism, device, or method configured to measure volumetric characteristics of a bodily-fluid such as, for example, a pressure sensor, a voltage sensor, a photo sensor, a velocity sensor, a flow meter, a strain gauge, a valve, a turbine, a float, displacement analysis, density analysis, weight analysis, optical analysis, ultrasound analysis, thermal analysis, Doppler analysis, electromagnetic field (emf) analysis, reflection analysis, obstruction analysis, area analysis, venturi analysis, coriolis analysis, visual analysis, and/or any other suitable sensor, analysis, and/or calculation (e.g., applying and/or using, for example, Boyle's law, ideal gas law, force calculation (force=mass*acceleration), and/or the like).