Patent Publication Number: US-2021186392-A1

Title: Fluid diversion mechanism for bodily-fluid sampling

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 14/926,784, entitled, “Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed on Oct. 29, 2015, which is a continuation of U.S. patent application Ser. No. 13/952,964, entitled, “Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed on Jul. 29, 2013 (now U.S. Pat. No. 9,204,864), which claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 61/678,404, entitled, “Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed on Aug. 1, 2012, the disclosure of each of which is incorporated herein by reference in its entirety. 
    
    
     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 and/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. Generally, when microbes tested for are present in the patient sample, the microbes flourish over time in the culture medium. After a pre-determined amount of time (e.g., a few hours to several days), the culture medium can 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. 
     In some instances, however, patient samples can become contaminated during procurement. For example, contamination of a patient sample may occur 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 microbes may be dislodged either directly or via dislodged tissue fragments, hair follicles, sweat glands and other adnexal structures. The transferred microbes may thrive in the culture medium and eventually yield a positive microbial test result, thereby falsely indicating the presence of such microbes in vivo. Such inaccurate results are a concern when attempting to diagnose or treat a suspected illness or condition. For example, 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. 
     As such, a need exists for improved bodily-fluid transfer devices and methods that reduce microbial contamination in bodily-fluid test samples. 
     SUMMARY 
     Devices for parenterally-procuring bodily-fluid samples with reduced contamination from microbes exterior to the bodily-fluid source, such as dermally-residing microbes, are described herein. In some embodiments, a device includes a pre-sample reservoir, an actuator mechanism, and a diverter. The pre-sample reservoir is configured to be fluidically coupled to a needle to receive and isolate a predetermined volume of bodily-fluid withdrawn from the patient. The actuator mechanism is operably coupled to the pre-sample reservoir such that, when actuated, a negative pressure is formed in the pre-sample reservoir that urges the bodily-fluid to flow into the pre-sample reservoir. The diverter is configured to selectively control fluid flow between the needle and the pre-sample reservoir. The diverter includes a flow control mechanism that defines a first fluid flow path and a second fluid flow path. The diverter is configured to be moved between a first configuration in which the bodily-fluid can flow through the first fluid flow path to the pre-sample reservoir, and a second configuration in which the bodily-fluid can flow through the second fluid flow path to a sample reservoir coupled to the diverter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic illustration of a bodily-fluid transfer device according to an embodiment. 
         FIG. 2  is a front view of a bodily-fluid transfer device according to an embodiment, in a first configuration. 
         FIG. 3  is a side view of the bodily-fluid transfer device of  FIG. 2 . 
         FIG. 4  is an exploded view of the bodily-fluid transfer device of  FIG. 2 . 
         FIG. 5  is a perspective view of a housing included in the bodily-fluid transfer device illustrated in  FIG. 2 . 
         FIG. 6  is a cross-sectional view of the housing illustrated in  FIG. 5  taken along the line X 2 -X 2 . 
         FIG. 7  is a perspective view of a diverter and an actuator included in the bodily-fluid transfer device of  FIG. 2 . 
         FIG. 8  is a cross-sectional view of the bodily-fluid transfer device of  FIG. 2  taken along the line X 1 -X 1 , in a second configuration. 
         FIG. 9  is a cross-sectional view of the bodily-fluid transfer device of  FIG. 2  taken along the line X 1 -X 1 , in a third configuration. 
         FIG. 10  is a perspective view of the bodily-fluid transfer device according to an embodiment. 
         FIG. 11  is an exploded view of the bodily-fluid transfer device of  FIG. 10 . 
         FIG. 12  is a cross-sectional view of a housing included in the bodily-fluid transfer device of  FIG. 10  taken along the line X 4 -X 4  in  FIG. 11 . 
         FIGS. 13-15  are cross-sectional views of the bodily-fluid transfer device taken along the line X 4 -X 4  in  FIG. 11 , in a first, second, and third configuration, respectively. 
     
    
    
     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, are described herein. In some embodiments, a device includes a pre-sample reservoir, an actuator mechanism, and a diverter. The pre-sample reservoir is configured to be fluidically coupled to a needle to receive and isolate a predetermined volume of bodily-fluid withdrawn from the patient. The actuator mechanism is operably coupled to the pre-sample reservoir such that, when actuated, a negative pressure is formed in the pre-sample reservoir that urges the bodily-fluid to flow into the pre-sample reservoir. The diverter is configured to selectively control fluid flow between the needle and the pre-sample reservoir. The diverter includes a flow control mechanism that defines a first fluid flow path and a second fluid flow path. The diverter is configured to be moved between a first configuration in which the bodily-fluid can flow through the first fluid flow path to the pre-sample reservoir, and a second configuration in which the bodily-fluid can flow through the second fluid flow path to a sample reservoir coupled to the diverter. 
     In some embodiments, a method for procuring bodily-fluid samples from a patient using a parenterally sampling device that includes an actuation mechanism, a flow control mechanism and a pre-sample reservoir includes establishing fluid communication between a patient and the pre-sample reservoir. A first volume of bodily-fluid is withdrawn by moving the actuation mechanism from a first position to a second position to create a negative pressure in the pre-sample reservoir. The flow control mechanism is moved from a first configuration in which bodily-fluid is allowed to flow through a first flow path from the patient to the pre-sample reservoir to a second configuration in which bodily-fluid is allowed to flow through a second flow path from the patient to a sample reservoir. 
     In some embodiments, a bodily-fluid sampling device includes a pre-sample reservoir, a diverter mechanism, and an actuator. The pre-sample reservoir is configured to be fluidically coupled to a needle. The pre-sample is configured to have a negative pressure and configured to receive and isolate a predetermined volume of bodily-fluid withdrawn from a patient, via the needle. The diverter mechanism is configured to be fluidically coupled to the pre-sample reservoir. The diverter mechanism includes a flow control mechanism configured for rotational movement between a first configuration in which the flow control mechanism and the diverter mechanism collectively define a first fluid flow path between the needle and the pre-sample reservoir and a second configuration in which the flow control mechanism and the diverter mechanism collectively define a second fluid flow path between the needle and a sample reservoir operably coupled to the diverter mechanism. The actuator is rotatably coupled to the diverter mechanism and configured to be rotated from a first position, wherein the flow control mechanism is in the first configuration, to a second position, wherein the flow control mechanism is in the second configuration. 
     In some embodiments, a method for procuring bodily-fluid samples from a patient using a parenterally sampling device that has a flow control mechanism and an integrated pre-sample reservoir having a negative pressure includes inserting a needle into the patient while the flow control mechanism is in a first configuration. The first configuration of the flow control mechanism is operable in preventing bodily-fluid from flowing from the patient to the integrated pre-sample reservoir. The flow control mechanism is moved from the first configuration to a second configuration. The second configuration of the flow control mechanism is operable in allowing bodily-fluid to flow through a first flow path defined at least in part by the flow control mechanism to the pre-sample reservoir. After a predetermined volume of bodily-fluid has been received in the pre-sample reservoir, the method includes moving the flow control mechanism from the second configuration to a third configuration. The third configuration of the flow control mechanism is operable in allowing bodily-fluid to flow through a second flow path defined at least in part by the flow control mechanism to a sample reservoir. 
     In some embodiments, an apparatus includes a diverter, a flow control mechanism, and an actuator mechanism. The diverter defines an inlet port, a first outlet port, and a second outlet port. The first outlet port is fluidically coupled to a first fluid reservoir and the second outlet port is fluidically coupled to a second reservoir, fluidically isolated from the first fluid reservoir. The flow control mechanism is configured to be operably coupled to the diverter. In use, the flow control mechanism is moved between a first configuration, in which a flow of bodily-fluid can enter the first fluid reservoir, and a second configuration, in which a flow of bodily-fluid can enter the second fluid reservoir. 
     In some embodiments, a bodily-fluid transfer device can be configured to selectively divert a first, predetermined amount of a flow of a bodily-fluid to a first reservoir before permitting the flow of a second amount of the bodily-fluid into a second reservoir. In this manner, the second amount of bodily-fluid can be used for diagnostic or other testing, while the first amount of bodily-fluid, which may contain microbes from a bodily surface, is isolated from the second amount of the bodily-fluid. The first amount of bodily fluid can be discarded or used for non-culture tests, such as one or more biochemical tests, blood counts, immunodiagnostic tests, cancer-cell detection tests, and the like where microbes from a bodily surface do not affect the test results. 
     As used in this specification and the appended claims, “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 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 discontinuous from each other. A set of walls can also be fabricated from multiple items that are produced separately and later joined together (e.g., via a weld, an adhesive or any suitable method). 
     As used herein, the words “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. 
       FIG. 1  is a schematic illustration of a portion of a bodily-fluid transfer device  100 , according to an embodiment. Generally, the bodily-fluid transfer device  100  (also referred to herein as “fluid transfer device” or “transfer device”) is configured to permit the withdrawal of bodily-fluid from a patient such that a first portion, amount, or volume of the withdrawn fluid is diverted away from a second portion, amount, 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 where contamination from microbes or other contaminants exterior to the bodily-fluid source (e.g., dermally-residing microbes) can affect test results. In other words, the transfer device  100  is configured to transfer a first, predetermined amount of a bodily-fluid to a first collection reservoir and a second amount of bodily-fluid to one or more bodily-fluid collection reservoirs that are fluidically isolated from the first collection reservoir, as described in more detail herein. 
     The transfer device  100  includes a diverter  120 , a first reservoir  170 , and a second reservoir  180 , fluidically isolated from the first reservoir  170 . The diverter  120  includes an inlet port  122  and two or more outlet ports, such as a first outlet port  124  and a second outlet port  126 , as shown in  FIG. 1 . The inlet port  122  is configured to be fluidically coupled to a medical device defining a pathway P for withdrawing and/or conveying the bodily-fluid from the patient to the transfer device  100 . For example, the inlet port  122  can be fluidically coupled to a needle, a fluid deliver member, or other lumen-containing device (e.g., flexible sterile tubing). In this manner, the diverter  120  can receive the bodily-fluid from the patient via the needle, other lumen-containing devices (e.g., cannula, catheters, etc.), or any other device suitable for collection of bodily-fluid samples from a patient. 
     The first outlet port  124  of the diverter  120  is configured to be fluidically coupled to the first reservoir  170 . In some embodiments, the first reservoir  170  is monolithically formed with the first outlet port  124  and/or a portion of the diverter  120 . In other embodiments, the first reservoir  170  can be mechanically and fluidically coupled to the diverter  120  via 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 first reservoir  170  can be physically (e.g., mechanically) coupled to the diverter  120  such that an interior volume defined by the first reservoir  170  is in fluid communication with the first outlet port  124  of the diverter  120 . In still other embodiments, the first reservoir  170  can be operably coupled to the first outlet port  124  of the diverter  120  via an intervening structure (not shown in  FIG. 1 ), such as a flexible sterile tubing. More particularly, the intervening structure can define a lumen configured to place the first reservoir  170  in fluid communication with the first outlet port  124 . 
     The first reservoir  170  is configured to receive and contain the first, predetermined amount of the bodily-fluid. In some embodiments, the first reservoir  170  is configured to contain the first amount of the bodily-fluid such that the first amount is fluidically isolated from a second amount of the bodily-fluid that is subsequently withdrawn from the patient. The first reservoir  170  can be any suitable reservoir for containing a bodily-fluid, such as a pre-sample reservoir described in detail in U.S. Patent Publication No. 2008/0145933 (“the &#39;933 Publication”), the disclosure of which is incorporated herein by reference in its entirety. For example, the first reservoir can be an evacuated sample tube (e.g., BD Vacutainer®) of sufficient size to collect the first amount of bodily fluid. As used in this specification, the terms “first, predetermined amount” and “first amount” describe an amount of bodily-fluid configured to be received or contained by the first reservoir  170 . Furthermore, while the term “first amount” does not explicitly describe a predetermined amount, it should be understood that the first amount is the first, predetermined amount unless explicitly described differently. 
     The second outlet port  126  of the diverter  120  is configured to be fluidically coupled to the second reservoir  180 . In some embodiments, the second reservoir  180  is monolithically formed with the second outlet port  126  and/or a portion of the diverter  120 . In other embodiments, the second reservoir  180  can be mechanically coupled to the second outlet port  126  of the diverter  120  or operably coupled to the second outlet port  126  via an intervening structure (not shown in  FIG. 1 ), such as described above with reference to the first reservoir  170 . The second reservoir  180  is configured to receive and contain the second amount of the bodily-fluid. For example, the second amount of bodily-fluid can be an amount withdrawn from the patient subsequent to withdrawal of the first amount. In some embodiments, the second reservoir  180  is configured to contain the second amount of the bodily-fluid such that the second amount is fluidically isolated from the first amount of the bodily-fluid. 
     The second reservoir  180  can be any suitable reservoir for containing a bodily-fluid, including, for example, a sample reservoir as described in the &#39;933 Publication incorporated by reference above. As used in this specification, the term “second amount” describes an amount of bodily-fluid configured to be received or contained by the second reservoir  180 . In some embodiments, the second amount can be any suitable amount of bodily-fluid and need not be predetermined. In other embodiments, the second amount received and contained by the second reservoir  180  is a second, predetermined amount. 
     In some embodiments, the first reservoir  170  and the second reservoir  180  can be coupled to (or formed with) the diverter  120  in a similar manner. In other embodiments, the first reservoir  170  and the second reservoir  180  need not be similarly coupled to the diverter  120 . For example, in some embodiments, the first reservoir  170  can be monolithically formed with the diverter  120  (e.g., the first outlet port  124 ) and the second reservoir  180  can be operably coupled to the diverter  120  (e.g., the second outlet port  126 ) via an intervening structure, such as a flexible sterile tubing. In other embodiments, the first reservoir  170  can be monolithically formed with the diverter  120  and the second fluid reservoir  180  can be removably coupled to the diverter  120 . 
     As shown in  FIG. 1 , the transfer device  100  further includes an actuator  140  and a flow control mechanism  130  first lumen  138  second lumen  139 . In some embodiments, the actuator  140  can be included in or otherwise operably coupled to the diverter  120 . In this manner, the actuator  140  can be configured to control a movement of the flow control mechanism  130  (e.g., between a first configuration and a second configuration). For example, the actuator  140  can be movable between a first position corresponding to the first configuration of the flow control mechanism  130 , and a second position, different than the first position, corresponding to the second configuration of the flow control mechanism  130 . In some embodiments, the actuator  140  is configured for uni-directional movement. For example, the actuator  140  can be moved from its first position to its second position, but cannot be moved from its second position to its first position. In this manner, the flow control mechanism  130  is prevented from being moved to its second configuration before its first configuration, thus requiring that the first amount of the bodily-fluid be directed to the first reservoir  170  and not the second reservoir  180 , as described in further detail herein. 
     The flow control mechanism  130  defines a first lumen  138  and a second lumen  139 . The flow control mechanism  130  is configured such that when in the first configuration, the first lumen  138  fluidically couples the inlet port  122  to the first outlet port  124  and when in the second configuration, the second lumen  139  fluidically couples the inlet port  122  to the second outlet port  126 . Said another way, when in the first configuration, the first lumen  138  defines at least a portion of a first fluid flow path between the inlet port  122  and the first outlet port  124 , and when in the second configuration, the second lumen  139  defines at least a portion of a second fluid flow path between the inlet port  122  and the second outlet port  126 . In some embodiments, the actuator  140  is coupled to the flow control mechanism  130  and is configured to move the flow control mechanism  130  in a translational motion between the first configuration and the second configuration. For example, in some embodiments, the flow control mechanism  130  can be in the first configuration when the flow control mechanism  130  is in a distal position relative to the transfer device  100 . In such embodiments, the actuator  140  can be actuated to move the flow control device  130  in the proximal direction to a proximal position relative to the transfer device  100 , thereby placing the flow control mechanism  130  in the second configuration. In other embodiments, the actuator  140  can be actuated to move the flow control mechanism  130  in a rotational motion between the first configuration and the second configuration. 
     Accordingly, when the flow control mechanism  130  is in the first configuration, the second outlet port  126  is fluidically isolated from the inlet port  122 . Similarly, when the flow control mechanism  130  is in the second configuration, the first outlet port  124  is fluidically isolated from the inlet port  122 . In this manner, the flow control mechanism  130  can direct, or divert the first amount of the bodily-fluid to the first reservoir  170  via the first outlet port  124  when the flow control mechanism  130  is in the first configuration and can direct, or divert the second amount of the bodily-fluid to the second reservoir  180  via the second outlet port  126  when the flow control mechanism  130  is in the second configuration. 
     In some embodiments, at least a portion of the actuator  140  can be operably coupled to the first reservoir  170 . In this manner, the actuator  140  (or at least the portion of the actuator  140 ) can be configured to introduce or otherwise facilitate the development of a vacuum within the first reservoir  170 , thereby initiating flow of the bodily-fluid through the transfer device  100  and into the first reservoir  170  when the diverter  120  is in its first configuration. The actuator  140  can include any suitable mechanism for actuating the transfer device  100  (e.g., at least the flow control mechanism  130 ) 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 diverter  120  can be configured such that the first amount of bodily-fluid need be conveyed to the first reservoir  170  before the diverter  120  will permit the flow of the second amount of bodily-fluid to be conveyed through the diverter  120  to the second reservoir  180 . In this manner, the diverter  120  can 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 amount (e.g., a sample) of bodily-fluid. Similarly stated, the diverter  120  can be configured to prevent a health care practitioner from collecting the second amount, or the sample, of bodily-fluid into the second reservoir  180  without first diverting the first amount, or pre-sample, of bodily-fluid to the first reservoir  170 . 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 (for example, dermally-residing microbes), in the bodily-fluid sample to be used for analysis. In other embodiments, the fluid transfer device  100  need not include a forced-compliance feature or component. 
     In some embodiments, the actuator  140  can have a third position, different than the first and second positions, which can correspond to a third configuration of the flow control mechanism  130 . When in the third configuration, the flow control mechanism  130  can fluidically isolate the inlet port  122  from both the first outlet port  124  and the second outlet port  126  simultaneously. Therefore, when the flow control mechanism  130  is in its third configuration, flow of bodily-fluid from the inlet port  122  to either the first reservoir  170  or the second reservoir  180  is prevented. In use, for example, the actuator  140  can be actuated to place the flow control mechanism  130  in the first configuration such that a bodily-fluid can flow from the inlet port  122  to the first reservoir  170 , then moved to the second configuration such that the bodily-fluid can flow from the inlet port  122  to the second reservoir  180 , then moved to the third configuration to stop the flow of bodily-fluid into and/or through the diverter  120 . In some embodiments, the flow control mechanism  130  can be moved to the third configuration between the first configuration and the second configuration. In some embodiments, the flow control mechanism  130  can be in the third configuration before being moved to either of the first configuration or the second configuration. In some embodiments, the flow control mechanism  130  can be moved between four configurations. For example, the flow control mechanism  130  can be disposed in the third configuration and moved through the first configuration and second configuration to the fourth configuration. In such embodiments, the fourth configuration can function similarly to the third configuration to fluidically isolate the inlet port  122  from the first outlet port  124  and the second outlet portion  126 . 
     In some embodiments, one or more portions of the transfer device  100  are disposed within a housing (not shown in  FIG. 1 ). For example, in some embodiments, at least a portion of one or more of the diverter  120 , the first reservoir  170 , and the actuator  140  can be disposed within the housing. In such an embodiment, at least a portion of the actuator  140  is accessible through the housing. Examples of suitable housings are described in more detail herein with reference to specific embodiments. 
       FIGS. 2-9  illustrate a transfer device  200  according to an embodiment. The transfer device  200  includes a housing  201 , a diverter  220 , and an actuator  240 . The transfer device  200  can be any suitable shape, size, or configuration. For example, while shown in  FIGS. 2 and 3  as being substantially cylindrical, the transfer device  200  can be square, rectangular, polygonal, and/or any other non-cylindrical shape. 
     The housing  201  includes a proximal end portion  202 , a distal end portion  203 , a first set of walls  204 , and a second set of wall  212  (also referred to herein as “inner walls”  212 ). The distal end portion  203  of the housing  201  is coupled to a container shroud  218  configured to receive at least a portion of an external fluid reservoir (not shown in  FIGS. 2-9 ). The container shroud  218  can be coupled to the housing  201  in any suitable manner. For example, in some embodiments, a portion of the container shroud  218  can form a friction fit within a portion of the housing  201 . In some embodiments, the container shroud  218  can be coupled to the housing  201  via a threaded coupling, an adhesive, a snap fit, a mechanical fastener and/or any other suitable coupling method. In other embodiments, the container shroud  218  is monolithically formed with the housing  201 . The container shroud  218  is configured to house a portion of an outlet adapter  229  ( FIG. 4 ) such that when the external fluid reservoir is disposed within the container shroud  218 , the external reservoir can be placed in fluid communication with the outlet adapter  229 , as described in further detail herein. 
     The proximal end portion  202  of the housing  201  receives the diverter  220  and is coupled to a cap  255 . The cap  255  is configured to substantially enclose a portion of the housing  201  (see for example, the exploded view of  FIG. 3 ). Similarly stated, the cap  255  is coupled to the proximal end portion  202  of the housing  201  such that the proximal end portion  202  is substantially closed. 
     As shown in  FIG. 5 , the walls  204  include a pivot protrusion  209  configured to extend substantially perpendicularly from an outer surface of the walls  204 . The pivot protrusion  209  defines an aperture  210  and is configured to receive a portion of the actuator  240  to pivotally couple the actuator  240  to the housing  201 . As shown in  FIG. 6 , the walls  204  define an inner volume  211  and a bypass chamber  205 . The bypass chamber  205  includes a first end portion  206  and a second end portion  207 . More specifically, the first end portion  206  is disposed at the proximal end portion  202  of the housing  201  and is substantially open such that a bodily-fluid can flow through the first end portion  206  and into the bypass chamber  205 . The second end portion  207  defines a lumen  208  configured to place the bypass chamber  205  in fluid communication with a volume of the housing  201  substantially outside of the bypass chamber  205 . 
     The inner walls  212  extend from an inner surface of the walls  204  of the housing  201  to substantially traverse a portion of the inner volume  211 . More specifically, the inner walls  212  are substantially annular and define a plunger volume  213  therebetween. The inner walls  212  also define a first opening  214  and a second opening  215 . The first opening  214  and the second opening  215  are configured to receive a portion of the diverter  220 , such that the portion of the diverter  220  can extend substantially continuously from the proximal end portion  202  of the housing  201  to the distal end portion  203  of the housing  201 . In this manner, the portion of the diverter  220  can transfer a bodily-fluid through the housing  201  to an external reservoir while fluidically isolating the bodily-fluid from a volume substantially outside the portion of the diverter  220 , as further described herein. 
     As shown in  FIGS. 5 and 6 , the plunger volume  213  is configured to extend through a portion of the walls  204  of the housing  201  such that the plunger volume  213  is open to a volume substantially outside of the housing  201 . Similarly stated, the walls  204  define an opening  216  configured to be disposed relative to the inner walls  212  to substantially align the opening  216  with a first end of the plunger volume  213 . The arrangement of the inner walls  212  relative to the housing  201  is such that the opening  216  and the plunger volume  213  are defined in a distal position relative to the pivot protrusion  209 , as further described herein. In addition, the inner walls  212  are configured such that a second end of the plunger volume  213 , opposite the first end, is in fluid communication with the lumen  208  of the bypass chamber  205 . Thus, at least a portion of the plunger volume  213  and at least a portion of the bypass chamber  205  can define a fluid reservoir  270  configured to receive a flow of bodily-fluid, as described in further detail herein. 
     Referring to  FIG. 7 , the diverter  220  includes a diverter plate  221 A, a transfer tube  228 , the outlet adapter  229 , and a flow control mechanism  230  (also referred to herein as “inlet port”). The diverter plate  221 A is configured to engage a surface of the proximal end portion  202  of the housing  201  to retain the diverter plate  221 A relative to the housing  201 . For example, in some embodiments, the proximal end portion  202  of the housing  201  can include a flange configured to receive a portion of the diverter plate  221 A. In some embodiments, the diverter plate  221 A can form a friction fit with an inner surface of the walls  204  of the housing  201 , thereby coupling the diverter plate  221 A to the housing  201 . In such embodiments, at least a portion of the diverter plate  221 A can be formed from a relatively flexible material such as a rubber or silicone. In this manner, the portion of the diverter plate  221 A can be configured to form a substantially fluid tight seal with the inner surface of the walls  204 . In other embodiments, the diverter plate  221 A can be coupled to the housing  201  via an adhesive. In such embodiments, the adhesive can be configured to form a substantially fluid tight or hermetic seal. 
     The diverter plate  221 A defines a first port  224  and a second port  226 . With the diverter plate  221 A disposed within the housing  201  as described above, the first port  224  is in fluid communication with the bypass chamber  205  of the housing  201 . Similarly, the second port  226  is in fluid communication with the outlet adapter  229  via the transfer tube  228 . Expanding further, a first end of the transfer tube  228  is physically and fluidically coupled to the second port  226  of the diverter plate  221 A and a second end of the transfer tube  228  is physically and fluidically coupled to the outlet adapter  229 , thereby defining a fluid flow path between the second port  226  and the outlet adapter  229 . In this manner, the transfer tube  228  is configured to extend from the proximal end portion  202  of the housing  201  to the distal end portion  203  of the housing  201  via the first opening  214  and the second opening  215  defined by the inner walls  212 . Moreover, with a portion of the outlet adapter  229  disposed within the container shroud  218  (as described above), the transfer tube  228  can be configured to transfer a bodily-fluid from the flow control mechanism  230  to an external fluid reservoir, when the external fluid reservoir is fluidically coupled to the outlet adapter  229 . 
     The flow control mechanism  230  (e.g., the inlet port) defines a lumen  238  and is movable between a first position and a second position. More specifically, the flow control mechanism  230  is at least partially disposed within a channel  260  defined by the cap  255  (see e.g.,  FIG. 4 ). When the flow control mechanism  230  is in the first position, the lumen  238  is substantially aligned with and in fluid communication with the first port  224  defined by the diverter plate  221 A. Similarly, when the flow control mechanism  230  is in the second position, the lumen  238  is configured to be substantially aligned with and in fluid communication with the second port  226  defined by the diverter plate  221 A. In some embodiments, the flow control mechanism  230  is configured to be manually moved between the first position and the second position via a force applied by a user (e.g., a medical professional). In other embodiments, the flow control mechanism  230  can be moved automatically by a portion of the transfer device  200  (e.g., the actuator  240  or any other suitable component). 
     As shown in  FIG. 7 , the actuator  240  includes a lever  241  and a plunger  248 . The actuator  240  is configured to be moved between a first configuration and a second configuration. The lever  241  has a proximal end portion  242 , a distal end portion  243 , a pivot portion  245 , and an engagement portion  244 . The pivot portion  245  is configured to be pivotally coupled to the pivot protrusion  209  of the housing  201 . For example, in some embodiments, a pivot pin (not shown) can be inserted through the pivot portion  245  of the lever  241  and the aperture  210  defined by the pivot protrusion  209 . Similarly, the engagement portion  244  of the lever  241  is configured to be movably coupled to an engagement portion  249  of the plunger member  248 . In this manner, the lever  241  can be actuated (e.g., pivoted) about the pivot portion  245  to move the plunger  248  between a first position and a second position, as described in further detail herein. 
     The plunger  248  is disposed within the plunger volume  213  and includes the engagement portion  249  and a seal member  254 . More specifically, the plunger  248  can be movably disposed within the plunger volume  213  such that the engagement portion  249  extends through the opening  216  defined by the walls  204 . The seal member  254  is disposed within the plunger volume  213  and engages the inner walls  212  to form a substantially fluid tight seal. The plunger  248  also defines a slot  251  configured to receive the transfer tube  228  of the diverter  220 . More specifically, the slot  251  enables the plunger  248  to move about the transfer tube  228  when the transfer tube  228  traverses the plunger volume  213  (e.g., passes through the first opening  214  and the second opening  215  defined by the inner walls  212 ). 
     In use, a user can engage the transfer device  200  and couple the flow control mechanism  230  to a proximal end portion of a lumen-defining device (not shown) such as, for example, a butterfly needle. With the flow control mechanism  230  coupled to the lumen-defining device, the lumen  238  is placed in fluid communication with the lumen defined by the lumen-defining device. Furthermore, the distal end portion of the lumen-defining device can be disposed within a portion of the body of a patient (e.g., a vein). In this manner, the lumen  238  is placed in fluid communication with the portion of the body. 
     With the flow control mechanism  230  coupled to the lumen-defining device, a user can place the transfer device  200  in the first configuration by aligning the flow control mechanism  230  with the first port  224  defined by the diverter plate  221 A. For example, in some embodiments, the flow control mechanism  230  is moved via manual intervention (e.g., a user slides the flow control mechanism  230  within the channel  260  to the first position). In other embodiments, the flow control mechanism  230  can be stored in the first configuration. In still other embodiments, the flow control mechanism  230  can be placed in the first configuration via the actuator  240  (e.g., a user engaging the actuator  240  can urge the flow control mechanism  230  to move to the first configuration). 
     As shown in  FIG. 8 , the lumen  238  is placed in fluid communication with the first port  224  when the flow control mechanism  230  is in the first configuration. In this manner, the user can apply an activation force to the lever  241 , thereby moving at least a portion of the actuator mechanism  240  towards the second configuration, as shown by the arrow AA in  FIG. 8 . More specifically, the user can engage the housing  201  and the lever  241  and exert a squeezing force, thereby moving the proximal end portion  242  of the lever in the direction of the arrow AA. The squeezing force on the proximal end portion  242  urges the lever  241  to pivot about the pivot protrusion  209  of the housing  201  and the pivot portion  245  of the lever  241  such that the distal end portion  243  moves in the direction of the arrow BB. Similarly stated, the user can pivot the lever  241  relative to the housing  201  such that the proximal end portion  242  is moved towards the housing  201  and the distal end portion  243  is moved away from the housing  201 . 
     With the engagement portion  249  of the plunger  248  coupled to the engagement portion  244  of the lever  241 , the movement of the distal end portion  243  of the lever  241  in the direction of the arrow BB urges the plunger  248  to move in the direction of the arrow CC. More specifically, the arrangement of the plunger  248 , the lever  241 , and the inner walls  212  is such that the pivoting motion of the distal end portion  243  of the lever  241  urges the plunger  248  to move in a translational motion within the plunger volume  213  defined by the inner walls  212 . In this manner, the plunger  248  is moved away from the bypass chamber  205  such that a volume of the fluid reservoir  270  is increased, thereby producing a negative pressure within the fluid reservoir  270 . 
     As shown by the arrow DD in  FIG. 8 , the lumen  238  of the flow control mechanism  230  and the first port  224  define a first fluid flow path that places the first end portion  206  of bypass chamber  205  in fluid communication with the flow control mechanism  230 . Furthermore, with the flow control mechanism  230  coupled to the lumen-defining device, the fluid reservoir  270  is placed in fluid communication with the portion of the patient (e.g., the vein). In this manner, the negative pressure within the fluid reservoir  270  produced by the movement of the plunger  248  introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the first end portion  206  of the bypass chamber  205  and into the fluid reservoir  270 . In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes. 
     In some embodiments, the magnitude of the suction force can be modulated by increasing or decreasing the amount of activation force (e.g., squeezing force) applied to the actuation mechanism  240 . For example, in some embodiments, it can be desirable to limit the amount of suction force introduced to a vein. In such embodiments, the user can reduce the amount of force applied to the actuator  240 . In this manner, the rate of change (e.g., increase) in the volume of the fluid reservoir  270  can be sufficiently slow to allow time for the negative pressure differential between the vein and the fluid reservoir  270  to come to equilibrium before further increasing the volume of the fluid reservoir  270 . Thus, the magnitude of the suction force can be modulated. 
     With the desired amount (e.g., a predetermined amount) of bodily-fluid transferred to the fluid reservoir  270 , the actuator  240  can be moved from the second configuration to a third configuration by reducing or removing the activation force on the proximal end portion  242  of the lever  241 . For example, in some embodiments, the actuator  240  can include a spring (not shown) configured to exert a force to move the lever  241  toward the first position relative to the housing  201 , thereby placing the transfer device  200  in the third configuration. In other embodiments, the user can apply a squeezing force to the distal end portion  243  of the lever  241  such that the lever  241  pivots about the pivot portion  245 . In this manner, the proximal end portion  242  of the lever  241  is configured to move substantially away from the housing  201  as indicated by the arrow EE in  FIG. 9 . In addition, the distal end portion  243  of the lever is configured to move substantially toward the housing  201  as indicated by the arrow FF in  FIG. 9 . 
     The movement of the distal end portion  243  of the lever  241  can be such that the plunger  248  moves within the plunger volume  213  toward the bypass chamber  205  to reduce the negative pressure within the fluid reservoir  270 , as described above. With the pressure equalized in the fluid reservoir  270 , the flow control mechanism  230  can be moved in the direction of the arrow GG in  FIG. 9  to place the lumen  238  in fluid communication with the second port  226  defined by the diverter plate  221 A. Similarly stated, the flow control mechanism  230  is moved within the channel  260  of the cap  255  to align the flow control mechanism  230  with the second port  226 . The alignment of the flow control mechanism  230  with the second port  226  is such that the portion of the patient (e.g., the vein) is placed in fluid communication with the outlet adapter  229  via the transfer tube  228 . 
     With the flow control mechanism  230  aligned with the second port  226 , the outlet adapter  229  can be coupled to an external fluid reservoir (not shown). Expanding further, the external fluid reservoir can be inserted into the container shroud  218  such that a portion of the outlet adapter  229  is disposed within the external fluid reservoir. For example, in some embodiments, the external fluid reservoir can be a BacT/ALERT® SN or a BacT/ALERT® FA, manufactured by BIOMERIEUX, INC. In such embodiments, the outlet adapter  229  can include a piercing member (not shown) such as a needle, configured to pierce a septum or membrane included in the fluid reservoir. 
     As shown by the arrow  1111  in  FIG. 9 , the lumen  238  of the flow control mechanism  230 , the second port  226 , the transfer tube  228 , and the outlet adapter  229  define a fluid flow path such that the external reservoir (not shown in  FIG. 9 ) is in fluid communication with the flow control mechanism  230  and, therefore, the portion of the patient (e.g., the vein). Furthermore, the external reservoir can be configured to define a negative pressure (e.g., the known external reservoirs referred to herein are vessels defining a negative pressure). The negative pressure within the external reservoir is such that the negative pressure differential between the external reservoir and the portion of the body of the patient introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir  270 . 
     In this manner, the bodily-fluid contained in the external reservoir is substantially free from microbes generally found outside of the portion of the patient (e.g., dermally residing microbes, microbes within a lumen defined by the transfer device  200 , microbes within the lumen defined by the lumen defining device, and/or any other undesirable microbe). With the desired amount of bodily-fluid contained in the external fluid reservoir, the user can remove the external fluid reservoir from the transfer device  200  and dispose of the transfer device  200  or utilize the diversion sample contained within the fluid reservoir  270  for other types of testing and/or related medical or non-medical purposes. 
     While the transfer device  200  is shown and described in  FIGS. 2-9  as disposing the diverter  220  within the housing  201 , in some embodiments, a transfer device can include a diverter and housing that are monolithically formed. For example,  FIGS. 10-15  illustrate a transfer device  300  according to an embodiment. As shown in  FIGS. 10 and 11 , the transfer device  300  includes a housing  301 , having a diverter  320  and defining a fluid reservoir  370 , a flow control mechanism  330 , and an actuator  340 . 
     The housing  301  includes a proximal end portion  302 , a distal end portion  303 , and a set of walls  304 . More particularly, the housing  301  includes a recessed surface  319  from which the walls  304  extend. Furthermore, at least a portion of the recessed surface  319  is configured to be a flat surface from which the diverter  320  can extend. Similarly stated, the diverter  320  is a set of walls configured to extend perpendicularly from the recessed surface  319 . In this manner, the diverter  320  can receive at least a portion of the flow control mechanism  330 , as described in further detail herein. While shown and described as extending perpendicularly from the recessed surface  319 , in other embodiments, the diverter  320  can extend from the recessed surface  319  at any suitable angular orientation. 
     As shown in  FIG. 12 , the diverter  320  includes an inlet port  322 , a first outlet port  324 , and a second outlet port  326 , and defines and inner volume  321 . The inner volume  321  is configured to extend through the recessed surface  319  such that the inner volume  321  is substantially open. Similarly stated, the diverter  320  is configured such that a set of walls that define the inner volume  321  are substantially cylindrical and define an open space therebetween (e.g., the inner volume  321 ). The inner volume  321  is configured to receive at least a portion of the flow control mechanism  330 , as further described herein. The inlet port  322  of the diverter  320  defines an inlet lumen  323 . The inlet lumen  323  is configured to be in fluid communication with the inner volume  321 . Similarly stated, the inlet lumen  323  of the inlet port  322  extends through the wall defining the inner volume  321  of the diverter  320 . 
     The inlet port  322  is further configured to be fluidically coupled to a medical device (not shown) defining a fluid flow pathway for withdrawing and/or conveying the bodily-fluid from a patient to the transfer device  300 . For example, the inlet port  322  can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) as described above. In this manner, when the lumen-defining device is disposed within a portion of a body of the patient (e.g., within a vein of the patient), the inner volume  321  of the diverter  320  is placed in fluid communication with the portion of the body of the patient. 
     The first outlet port  324  of the diverter  320  defines a first outlet lumen  325 . The first outlet lumen  325  is in fluid communication with the inner volume  321  of the diverter  320  and the fluid reservoir  370  (described above). Similarly stated, the first outlet lumen  325  is configured to extend through the wall defining the inner volume  321 , thereby placing the fluid reservoir  370  in fluid communication with the inner volume  321 . The second outlet port  326  of the diverter  320  defines a second outlet lumen  327  and is configured to be coupled to an external fluid reservoir. In this manner, the second outlet lumen  327  can extend through the wall defining the inner volume  321  to be in fluid communication with the inner volume  321 . Moreover, the second outlet port  326  can be fluidically coupled to the external reservoir to place the external fluid reservoir in fluid communication with the inner volume  321  via the second outlet lumen  327 , as described in further detail herein. 
     Referring back to  FIG. 11 , the actuator mechanism  340  includes an engagement portion  345  and an activation portion  346 . The actuator mechanism  340  can be coupled to the housing  301  in any suitable manner. For example, in some embodiments, a portion of the actuator mechanism  340  can be disposed within the inner volume  321 . In some embodiments, the walls  304  can include a feature (e.g., a tab, a lock, and/or the like) configured to selectively retain the actuator mechanism  340  in contact with the housing  301 . The activation portion  346  is configured to contact, mate, or otherwise engage the flow control mechanism  330 . In this manner, the engagement portion  345  can be engaged by a user to rotate the actuator mechanism  340  relative to the housing  301  to move the transfer device  300  between a first configuration, a second configuration, and a third configuration, as described in further detail herein. 
     As shown in  FIG. 13 , the flow control mechanism  330  defines a first lumen  338  and a second lumen  339  and is disposed within the inner volume  321  defined by the diverter  320 . In this manner, the flow control mechanism  330  defines a circular cross-sectional shape such that when the flow control mechanism  330  is disposed within the inner volume  321 , a portion of the flow control mechanism  330  forms a friction fit with the walls of the diverter  320  defining the inner volume  321 . For example, in some embodiments, the flow control mechanism  330  is formed from silicone and has a diameter larger than the diameter of the walls defining the inner volume  321 . As such, the diameter of the flow control mechanism  330  is reduced when the flow control mechanism  330  is disposed within the inner volume  321 . Thus, the outer surface of the flow control mechanism  330  forms a friction fit with the inner surface of the walls defining the inner volume  321 . In other embodiments, the flow control mechanism  330  can be any suitable elastomer configured to deform when disposed within the inner volume  321  of the diverter  320 . 
     The flow control mechanism  330  can be coupled to and/or can otherwise engage the actuator  340 . For example, in some embodiments, the actuator  340  can be coupled to the flow control mechanism  330  via a mechanical fastener and/or adhesive. In other embodiments, the actuator  340  and the flow control mechanism  330  can be coupled in any suitable manner such that the flow control mechanism  330  moves concurrently with the actuator  340  when the actuator  340  is rotated relative to the housing  301 . In this manner, the flow control mechanism  330  can be moved relative to the diverter  320  to place the first lumen  338  or the second lumen  339  in fluid communication with the inlet port  322 , the first outlet port  324 , and/or the second outlet port  326 , as described in further detail herein. 
     As shown in  FIG. 13 , the transfer device  300  can be stored in the first configuration in which the flow control mechanism  330  fluidically isolates the inlet port  322  from the first outlet port  324  and the second outlet port  326 . Expanding further, the flow control mechanism  330  can be disposed within the inner volume  321  of the diverter  320  such that the first lumen  338  and the second lumen  339  are fluidically isolated from the inlet lumen  323 , the first outlet lumen  325 , and the second outlet lumen  327 . In such embodiments, the friction fit defined by the flow control mechanism  330  and the walls of the diverter  320  defining the inner volume  321  maintain the flow control mechanism  330  in the first configuration until, for example, user intervention moves the actuator  340 , thereby moving the flow control mechanism  330  to the second configuration. 
     In use, a user can manipulate the transfer device  300  to couple the inlet port  322  to a proximal end portion of a lumen-defining device (not shown) such as, for example, a butterfly needle and/or the like. Furthermore, the distal end portion of the lumen-defining device can be disposed within a portion of the body of a patient (e.g., a vein) to place the inlet lumen  323  in fluid communication with the portion of the body of the patient. In a similar manner, the second outlet port  326  can be coupled to an external fluid reservoir (not shown). The external fluid reservoir can be any suitable reservoir. For example, in some embodiments, the external fluid reservoir can be a BacT/ALERT® SN or a BacT/ALERT® FA, manufactured by BIOMERIEUX, INC. 
     With the inlet port  322  coupled to the lumen-defining device and the second outlet port  326  coupled to the external fluid reservoir, a user can begin the transfer of a bodily-fluid by applying an activation force to the engagement portion  344  of the actuator  340 , thereby moving the actuator  340  to a second position, as shown by the arrow II in  FIG. 14 . The movement of the actuator  340  is such that the flow control member  340  is urged to move in the direction of the arrow II, thereby placing the transfer device  300  in the second configuration. In addition, the fluid reservoir  370  can be configured such that a negative pressure exists within an inner volume  373  such as, for example, an evacuated sample tube (e.g., BD Vacutainer®). Therefore, when the flow control mechanism  330  is placed in its second configuration, a negative pressure differential introduces a suction force within the first lumen  338  of the flow control mechanism  330 , and the inlet lumen  323  and the first outlet lumen  325  of the diverter  320 . 
     As shown by the arrow JJ, the inlet lumen  323  of the inlet port  322 , the first lumen  338  of the flow control mechanism  330 , and the first outlet lumen  325  of the first outlet port  324  define a first fluid flow path that places the inner volume  373  defined by the fluid reservoir  370  in fluid communication with the inlet port  322 . Furthermore, with the inlet port  322  coupled to the lumen-defining device, the first fluid flow path places the fluid reservoir  370  in fluid communication with the portion of the patient (e.g., the vein) and at least a portion of the suction force (e.g., applied by the negative pressure differential, as described above) is introduced to the portion of the patient. Thus, a bodily-fluid can be drawn into the fluid reservoir  370 . In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes dislodged during the insertion of the lumen-defining device. 
     In some embodiments, the magnitude of the suction force can be modulated by further moving the actuator  340  in the direction of the arrow II. For example, in some embodiments, it can be desirable to limit the amount of suction force introduced to a vein. In such embodiments, the user can move the actuator  340  and the flow control mechanism  330  (e.g., in the II direction) to constrict or otherwise reduce the size of at least a portion of the first fluid pathway (e.g., an inner diameter) between the inlet lumen  323  and the first lumen  338  and the first outlet lumen  325  and the first lumen  338 , thereby reducing the suction force introduced into the vein of the patient. 
     With the desired amount of bodily-fluid transferred to the fluid reservoir  370 , a user can engage the transfer device  300  to move the transfer device  300  from the second configuration to the third configuration, wherein a flow of bodily-fluid is transferred to the external reservoir (e.g., such as those described above). In some embodiments, the desired amount of bodily-fluid transferred to the fluid reservoir  370  is a predetermined amount of fluid. For example, in some embodiments, the transfer device  300  can be configured to transfer bodily-fluid until the pressure within the fluid reservoir  370  is equilibrium with the pressure of the portion of the body in which the lumen-defining device is disposed (e.g., the vein), as described above. In some embodiments, at least a portion of the fluid reservoir  370  can be transparent to allow visualization of the bodily fluid flowing into the fluid reservoir  370 . Although not shown, the fluid reservoir  370  can include indicators (e.g., 0.1 mL, 0.5 mL, 1 mL, 2 mL, 3 mL, 4 mL, and/or 5 mL graduation marks) that the user can visualize to determine the volume of bodily-fluid that has been received in the fluid reservoir  370 . 
     The transfer device  300  can be moved from the second configuration to the third configuration by moving the actuator mechanism  340  in the direction of the arrow KK in  FIG. 15 . As the actuator mechanism  340  is moved from its second configuration toward its third configuration, the actuator  340  rotates the flow control mechanism  330  toward the third configuration. In this manner, the first lumen  338  is fluidically isolated from the inlet lumen  323  and the first outlet lumen  325 , and the second lumen  339  is placed in fluid communication with the inlet lumen  323  defined by the inlet port  322  and the second outlet lumen  327  defined by the second outlet port  326 . 
     As shown by the arrow LL in  FIG. 15 , the inlet lumen  323  of the inlet port  322 , the second lumen  339  of the flow control mechanism  330 , and the second outlet lumen  327  of the second outlet port  326  define a second fluid flow path that can place the external reservoir (not shown in  FIG. 15 ) in fluid communication with the inlet port  322  and, therefore, the portion of the patient (e.g., the vein). Furthermore, the external reservoir can be configured to define a negative pressure (e.g., the known external reservoirs referred to herein are vessels defining a negative pressure). The negative pressure within the external reservoir is such that the negative pressure differential between the external reservoir and the portion of the body of the patient introduces a suction force within the portion of the patient. Therefore, a desired amount of bodily-fluid is drawn into the external reservoir and is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the fluid reservoir  370 . 
     The bodily-fluid contained in the external reservoir is substantially free from microbes generally found outside of the portion of the patient (e.g., dermally residing microbes, microbes within a lumen defined by the transfer device  300 , microbes within the lumen defined by the lumen defining device, and/or any other undesirable microbe). In some embodiments, with the desired amount of bodily-fluid contained in the external fluid reservoir, the user can further move the actuator  340  in the proximal direction to place the transfer device  300  in a fourth configuration. In such embodiments, the actuator  340  can be moved in the direction of the arrow KK to fluidically isolate the first lumen  338  and the second lumen  339  of the flow control mechanism  330  from the inlet lumen  323 , the first outlet lumen  325 , and the second outlet lumen  327  of the diverter  320 . Thus, the bodily-fluid contained within the fluid reservoir  370  is fluidically isolated from a volume outside the fluid reservoir  370  and the external reservoir can be decoupled from the transfer device  300 . In some instances, additional external reservoirs can then be fluidically coupled to the transfer device  300 , and the user can rotate the actuator  340  back to the third configuration to establish fluid communication between the patient and the additional external reservoir and/or sample vessel. In some embodiments, the actuator  340  can include a sensible indication (e.g., audible, visual and/or tactile) of which position the transfer device  300  is in. For example, the actuator can include numeric indicators of the position of the transfer device  300 . 
     While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Additionally, certain steps may be partially completed before proceeding to subsequent steps. 
     While the lever  241  is described in reference to  FIG. 9  as being returned to the first position relative to the housing  201  when the transfer device  200  is moved to the third configuration, in other embodiments, the lever  241  need not be moved from the second position relative to the housing  201 . For example, in some embodiments, the pressure differential between the vein and the fluid reservoir  270  can be in equilibrium without substantially reducing the volume of the fluid reservoir  270 . Thus, the plunger  248  need not be moved toward the bypass chamber  205  and the lever  241  of the actuator  240  can remain in the second position relative to the housing  201  while a bodily-fluid is transferred to an external reservoir. 
     While various embodiments have been particularly shown and described, various changes in form and details may be made. For example, while the actuator  340  is shown and described with respect to  FIGS. 13-15  as being rotated in a single direction, in other embodiments, an actuator can be rotated in a first direction (e.g., in the direction of the arrow II in  FIG. 14 ) and a second direction, opposite the first. In such embodiments, the rotation in the second direction can be configured to move a transfer device through any number of configurations. In other embodiments, the rotation of the actuator in the second direction can be limited. For example, in some embodiments, the actuator can be limitedly rotated in the second direction to reduce the diameter of a flow path between a flow control mechanism and a lumen such as to reduce a suction force, as described above. In some embodiments, the actuator 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 is filed with a predetermined volume of bodily fluid and the user has moved the actuator to being drawing additional sample, the actuator cannot be moved back to establish fluid communication the first sample volume. 
     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 transfer device  300  is shown and described with respect to  FIGS. 13-15  as having a first, second, third and forth configuration, in other embodiments, the transfer devices described herein may have more or fewer configurations. 
     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.