Patent Publication Number: US-11660030-B2

Title: Syringe-based 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. 17/388,979, filed Jul. 29, 2021, entitled “Syringe-Based Fluid Diversion Mechanism for Bodily Fluid Sampling,” which is a continuation of U.S. patent application Ser. No. 16/255,058, filed Jan. 23, 2019, entitled “Syringe-Based Fluid Diversion Mechanism for Bodily Fluid Sampling”, which is a continuation of U.S. patent application Ser. No. 14/880,397, filed Oct. 12, 2015, entitled “Syringe-Based Fluid Diversion Mechanism for Bodily Fluid Sampling” (now U.S. Pat. No. 10,206,613), which is a continuation of U.S. patent application Ser. No. 14/094,073, filed Dec. 2, 2013, entitled “Syringe-Based Fluid Diversion Mechanism for Bodily Fluid Sampling” (now U.S. Pat. No. 9,155,495), which claims priority to and the benefit of U.S. Provisional Application Ser. No. 61/731,620, entitled “Syringe Based Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filed Nov. 30, 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 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 PCR-based approaches. Generally, when such microbes 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. 
     Patient samples, however, can become contaminated during procurement. 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 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. 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 syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination from a patient includes a housing, a pre-sample reservoir, and an actuator mechanism. The housing has a proximal end portion and a distal end portion and defines an inner volume therebetween. The proximal end portion is substantially open and the distal end portion has a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient. The pre-sample reservoir is fluidically couplable to the port and is configured to receive and isolate a first volume of bodily fluid withdrawn from the patient. The actuator mechanism is at least partially disposed in the inner volume of the housing and has a proximal end portion and a distal end portion. The distal end portion includes a sealing member and the proximal end portion includes an engagement portion configured to allow a user to selectively move the actuator mechanism between a first configuration in which the bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration in which the bodily fluid can flow from the port to a sample reservoir defined at least in part by the sealing member and the housing. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a schematic illustration of a syringe-based transfer device according to an embodiment. 
         FIG.  2    is a front view of a syringe-based transfer device according to an embodiment, in a first configuration. 
         FIG.  3    is an exploded view of the syringe-based transfer device of  FIG.  2   . 
         FIG.  4    is a cross-sectional view of the syringe-based transfer device illustrated in  FIG.  2    taken along the line X 1 -X 1 , in the first configuration. 
         FIG.  5    is a cross-sectional view of the syringe-based transfer device of  FIG.  2    taken along the line X 1 -X 1 , in a second configuration. 
         FIG.  6    is a cross-sectional view of the syringe-based transfer device of  FIG.  2    taken along the line X 1 -X 1 , in a third configuration. 
         FIG.  7    is a front view of a syringe-based transfer device according to an embodiment, in a first configuration. 
         FIG.  8    is an exploded view of the syringe-based transfer device of  FIG.  7   . 
         FIG.  9    is a cross-sectional view of the syringe-based transfer device of  FIG.  7    taken along the line X 2 -X 2 , in the first configuration. 
         FIG.  10    is a cross-sectional view of the syringe-based transfer device of  FIG.  7    taken along the line X 2 -X 2 , in a second configuration. 
         FIG.  11    is a front view of a syringe-based transfer device according to an embodiment, in a first configuration. 
         FIG.  12    is an exploded view of the syringe-based transfer device of  FIG.  11   . 
         FIG.  13    is a cross-sectional view of the syringe-based transfer device of  FIG.  11    taken along the line X 3 -X 3 , in the first configuration. 
         FIG.  14    is a cross-sectional view of the syringe-based transfer device of  FIG.  11    taken along the line X 3 -X 3 , in a second configuration. 
         FIG.  15    is a cross-sectional view of the syringe-based transfer device of  FIG.  11    taken along the line X 3 -X 3 , in a third configuration. 
         FIG.  16    is a flowchart illustrating a method of using a syringe-based transfer device to obtain a bodily fluid sample from a patient. 
     
    
    
     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 syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination from a patient includes a housing, a pre-sample reservoir, and an actuator mechanism. The housing has a proximal end portion and a distal end portion and defines an inner volume therebetween. The proximal end portion is substantially open and the distal end portion has a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient. The pre-sample reservoir is fluidically couplable to the port and is configured to receive and isolate a first volume of bodily fluid withdrawn from the patient. The actuator mechanism is at least partially disposed in the inner volume of the housing and has a proximal end portion and a distal end portion. The distal end portion includes a sealing member and the proximal end portion includes an engagement portion configured to allow a user to selectively move the actuator mechanism between a first configuration in which the bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration in which the bodily fluid can flow from the port to a sample reservoir defined at least in part by the sealing member and the housing. 
     In some embodiments, a syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination from a patient includes a housing and an actuator mechanism. The housing has a proximal end portion and a distal end portion and defines an inner volume therebetween. The proximal end portion is substantially open and the distal end portion has a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient. The actuator mechanism is movably disposed in the inner volume. The actuator mechanism includes a first member having a proximal end portion and a distal end portion and defining an inner volume therebetween, and a second member movably disposed in the inner volume of the first member. The distal end portion of the first member includes a first plunger including a flow channel configured to allow selective fluid communication between the inner volume defined by the housing and the inner volume defined by the first member. The second member includes a second plunger disposed at a distal end portion of the second member and an engagement portion configured to allow a user to selectively move the actuator mechanism. 
     In some embodiments, a syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination from a patient includes a housing, an actuator mechanism, and a piercing member. The housing has a proximal end portion and a distal end portion and defines an inner volume therebetween. The proximal end portion is substantially open and the distal end portion has a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient. The actuator mechanism is movably disposed in the inner volume of the housing. The actuator mechanism has a proximal end portion and a distal end portion and defining an inner volume therebetween. The distal end portion includes a plunger including a flow channel. The proximal end portion is substantially open and configured to receive a vacuum-sealed sample tube. The piercing member is disposed in the inner volume of the actuator mechanism and defines a lumen fluidically coupled to the flow channel of the plunger. The flow channel of the plunger and the piercing member configured to allow selective fluid communication between the inner volume defined by the housing and the inner volume defined by the actuator mechanism. 
     In some embodiments, a syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination from a patient includes a housing, an actuator mechanism, and a flow control mechanism. The housing has a proximal end portion and a distal end portion and defines an inner volume therebetween. The proximal end portion is substantially open and the distal end portion has a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient. The actuator mechanism is movably disposed in the inner volume of the housing and has a proximal end portion and a distal end portion. The distal end portion includes a first plunger and the proximal end portion including an engagement portion configured to allow a user to selectively move the actuator mechanism. A second plunger is movably disposed in the inner volume of the housing and releasably coupled to the actuator mechanism. The second plunger defines a flow channel configured to be placed in selective fluid communication with the port. The flow control mechanism is operable to selectively control fluid flow between the port and a pre-sample reservoir defined by the second plunger and the housing. The flow control mechanism is configured to be moved between a first configuration in which the bodily fluid can flow through a first flow path to the pre-sample reservoir, and a second configuration in which the bodily fluid can flow through a second flow path to a sample reservoir collectively defined by the first plunger, the second plunger, and the housing. 
     In some embodiments, a method of using a syringe-based transfer device, including a housing with a port and an actuator mechanism movably disposed in the housing, to obtain a bodily fluid sample from a patient includes establishing fluid communication between the patient and the port of the syringe-based transfer device and establishing fluid communication between the port and a pre-sample reservoir. A first volume of bodily fluid is transferred to the pre-sample reservoir with the syringe-based transfer device. The pre-sample reservoir is fluidically isolated from the port to sequester the first volume of bodily fluid in the pre-sample reservoir. After the first volume of bodily fluid has been sequestered in the pre-sample reservoir, fluid communication is established between the port and a sample reservoir defined at least in part by the actuator mechanism and the housing. The actuator mechanism is moved from a first position to a second position to draw a second volume of bodily fluid from the patient into the sample reservoir. 
     In some embodiments, an apparatus includes a housing and an actuator mechanism. The apparatus further includes a first fluid reservoir and a second fluid reservoir, fluidically isolated from the first fluid reservoir, defined at least in part by the housing and/or the actuator mechanism. The housing includes a port configured to receive a bodily-fluid. The housing and the actuator mechanism collectively define a first fluid flow path and a second fluid flow path. The first fluid flow path is configured to transfer a first flow of bodily-fluid from the port to the first fluid reservoir when the actuator mechanism is in a first position relative to the housing. The second fluid flow path is configured to transfer a second flow of bodily-fluid, substantially free from undesirable microbes that are not representative of in vivo patient condition, from the port to the second fluid reservoir when the actuator mechanism is in a second position relative to the housing. 
     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 and/or other external source, is isolated from the bodily-fluid to be tested for microbial presence but yet can be used for other blood tests as ordered by clinician (e.g., complete blood count “CBC”, immunodiagnostic tests, cancer-cell detection tests, or the like). 
     As referred to 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 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 in this specification, 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. 
     As used in this specification and the appended claims, 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 in this specification and the appended claims, 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. 
       FIG.  1    is a schematic illustration of a portion of a syringe-based transfer device  100 , according to an embodiment. Generally, the syringe-based transfer device  100  (also referred to herein as “bodily-fluid transfer device,” “fluid transfer device,” or “transfer device”) is configured to permit the withdrawal of bodily-fluid from a patient such that a first portion or amount of the withdrawn fluid is fluidically isolated and diverted away from a second portion or amount 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 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 (e.g., sample reservoirs) fluidically isolated from the first collection reservoir, as described in more detail herein. 
     The transfer device  100  includes a housing  101 , an actuator mechanism  140 , a first fluid reservoir  180  (also referred to herein as “first reservoir” or “pre-sample reservoir”), and a second fluid reservoir  190  (also referred to herein as “second reservoir” or “sample reservoir”), different from the first reservoir  180 . The housing  101  can be any suitable shape, size, or configuration and is described in further detail herein with respect to specific embodiments. As shown in  FIG.  1   , the housing  101  includes a port  105  that can be at least temporarily physically and 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 port  105  can be a Luer-Lok® or the like configured to be physically and fluidically coupled to a needle, a cannula, or other lumen-containing device. In other embodiments, the port  105  can be monolithically formed with at least a portion of the lumen-containing device. In this manner, the port  105  can receive the bodily-fluid from the patient via the pathway P as further described herein. 
     As shown in  FIG.  1   , the housing  101  defines an inner volume  111  that is configured to receive a portion of the actuator mechanism  140 . More specifically, the actuator mechanism  140  is at least partially disposed within the inner volume  111  of the housing  101  and is movable between a first configuration and a second configuration relative to the housing  101 . The housing  101  is also configured to house at least a portion of the first reservoir  180  and at least a portion of the second reservoir  190 . For example, in some embodiments, the first reservoir  180  and/or the second reservoir  190  can be at least temporarily disposed within the inner volume  111  defined by the housing  101 . In other embodiments, the first reservoir  180  and/or the second reservoir  190  can be at least partially defined by a set of walls of the housing  101  that define the inner volume  111 . Similarly stated, a portion of the inner volume  111  can form at least a portion of the first reservoir  180  and/or a portion of the second reservoir  190 . 
     The actuator mechanism  140  can be any suitable shape, size, or configuration. For example, in some embodiments, the shape and size of at least a portion of the actuator mechanism  140  substantially corresponds to the shape and size of the walls of the housing  101  defining the inner volume  111 . As described above, at least a portion of the actuator mechanism  140  is movably disposed within the inner volume  111  of the housing  101 . For example, in some embodiments, a distal end portion of the actuator mechanism  140  is disposed within the inner volume  111  of the housing  101  and a proximal end portion of the actuator mechanism  140  is disposed substantially outside the housing  101 . In this manner, a user can engage the proximal end portion of the actuator mechanism  140  to move the portion of the actuator mechanism  140  disposed within the inner volume  111  between the first configuration and the second configuration relative to the housing  101 . In some embodiments, the actuator mechanism  140  can be disposed in a third configuration (or storage configuration) relative to the housing  101 , as further described herein. 
     While not shown in  FIG.  1   , in some embodiments, the actuator mechanism  140  can include a first member and a second member. In such embodiments, both the first member and the second member can be collectively moved within the inner volume  111  of the housing  101 . In addition, the first member and the second member can be configured to move independently within the housing  101 . Similarly stated, the first member can be moved relative to the second member and/or the second member can be moved relative the first member, as further described below with respect to specific embodiments. In some embodiments, the first member and/or the second member can form a piston or plunger configured to move within the inner volume  111 . 
     Furthermore, a portion of the piston or plunger can form a substantially fluid tight seal with the walls of the housing  101  defining the inner volume  111 . In this manner, the housing  101  and the actuator mechanism  140  can collectively form a sealed, air-tight cavity (e.g., a syringe) such that the actuator mechanism  140  (or at least a portion of the actuator mechanism  140 ) can be configured to introduce or otherwise facilitate the development of a vacuum within the inner volume  111 . 
     The first reservoir  180  can be any suitable reservoir for containing the bodily-fluid. For example, in some embodiments, the first reservoir  180  is defined by a portion of the walls of the housing  101  defining the inner volume  111  and a portion of the actuator mechanism  140 . In other embodiments, the first reservoir  180  is defined by only the actuator mechanism  140 . In still other embodiments, the first reservoir  180  can be a pre-sample reservoir described in detail in U.S. Pat. No. 8,197,420 (“the &#39;420 patent”), the disclosure of which is incorporated herein by reference in its entirety. In this manner, the first reservoir  180  can be selectively placed in fluid communication with the housing  101  or the actuator mechanism  140  either directly (e.g., physically and fluidically coupled to the housing  101  or the actuator mechanism  140 ) or indirectly (e.g., fluidically coupled via intervening structure such as sterile flexible tubing). 
     The first reservoir  180  is configured to receive and contain the first, predetermined amount of the bodily-fluid. More specifically, when the actuator mechanism  140  is in the first configuration, a portion of the actuator mechanism  140  and a portion of the housing  101  can define a first fluid flow path  181  configured to fluidically couple the port  105  of the housing  101  to the first reservoir  180 . In some embodiments, the actuator mechanism  140  can be moved to the first configuration (e.g., from the third configuration described above) and can introduce a vacuum that facilitates the flow of the bodily-fluid through the first flow path  181  and into the first reservoir  180 . The first reservoir  180  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 (different than the first amount of bodily-fluid) that is subsequently withdrawn from the patient. 
     The second reservoir  190  can be any suitable reservoir and is configured to receive and contain the second amount of the bodily-fluid. In some embodiments, the second reservoir  190  is defined by a portion of the walls of the housing  101  defining the inner volume  111  and a portion of the actuator member  140 . In this manner, when the actuator mechanism  140  is in the second configuration, a portion of the actuator mechanism  140  and a portion of the housing  101  can define a second fluid flow path  191  configured to fluidically couple the port  105  to the second reservoir  190 . In some embodiments, the movement of the actuator mechanism  140  to the second configuration can be such that a second vacuum force facilitates the flow of the bodily-fluid through the second flow path  191  and into the second reservoir  190 . 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  190  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. 
     As described above, the transfer device  100  can be used to transfer a bodily-fluid from a patient to the first reservoir  180  and/or second reservoir  190  included in the transfer device  100 . More specifically, the flow of the first amount of bodily-fluid transferred to the first reservoir  180  can be such that dermally-residing microbes dislodged during a venipuncture event and/or other external sources (e.g. ambient airborne microbes, transferred from the skin of the practitioner collecting the sample, etc.) become entrained in the flow and are thereby transferred to the first reservoir  180 . In addition, the first reservoir  180  fluidically isolates the first amount such that when the subsequent second amount is withdrawn into the second reservoir  190 , the second amount is substantially free from the dermally-residing microbes. Although not shown in  FIG.  1   , in some embodiments, the syringe-based transfer device  100  can be coupled to a device in fluid communication with the patient that is also configured to reduce contamination of a patient sample. For example, in some embodiments, the syringe-based transfer device  100  can be used with a lumenless needle or the like such as those described in U.S. Patent Application Ser. No. 61/777,758, entitled “Lumenless Needle for Bodily-Fluid Sample Collection,” filed on Mar. 12, 2013 (“the &#39;758 application”) the disclosure of which is incorporated herein by reference in its entirety. 
     In some embodiments, the transfer device  100  can be configured such that the first amount of bodily-fluid need be conveyed to the first reservoir  180  before the transfer device  100  will permit the flow of the second amount of bodily-fluid to be conveyed through the second flow path  191  to the second reservoir  180 . In this manner, the transfer device  100  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 collection of the second amount (e.g., a sample) of bodily-fluid. Similarly stated, the transfer device  100  can be configured to prevent a health care practitioner from collecting the second amount, or the sample, of bodily-fluid into the second reservoir  190  without first diverting the first amount, or pre-sample, of bodily-fluid into the first reservoir  180 . 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 dermally-residing microbes and/or other external undesirable contaminants, 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 mechanism  140  can have a fourth configuration, different than the first, second, and third configurations. In such embodiments, the actuator mechanism  140  can be moved towards the fourth configuration when the transfer device  100  has collected the second amount of the bodily-fluid and has been removed from contact with the patient. When in the fourth configuration, the first fluid reservoir  180  can maintain the first amount of bodily-fluid in fluid isolation and the second fluid reservoir  190  can be maintained in fluid communication with the port  105 . Therefore, when the actuator mechanism  140  is moved toward the fourth configuration the transfer device  100  can transfer a portion of the second amount of the bodily-fluid from the second reservoir  190  to any suitable container (e.g., a vile, a test tube, a petri dish, a culture medium, a test apparatus, or the like) such that the portion of the second amount of bodily-fluid can be tested. 
       FIGS.  2 - 6    illustrate a syringe-based transfer device  200  according to an embodiment. The syringe-based transfer device  200  (also referred to herein as “bodily-fluid transfer device,” “fluid transfer device,” or “transfer device”) includes a housing  201  and an actuator mechanism  240 . Furthermore, the transfer device  200  is configured to include or define a first fluid reservoir  280  (also referred to herein as “first reservoir” or “pre-sample reservoir”) and a second fluid reservoir  290  (also referred to herein as “second reservoir” or “sample reservoir”). 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. 
     As shown in  FIGS.  2  and  3   , the housing  201  includes a proximal end portion  202  and a distal end portion  203  and defines an inner volume  211  therebetween. In some embodiments, the housing  201  can be substantially similar to a syringe body. The proximal end portion  202  of the housing  201  is substantially open and is configured to receive at least a portion of the actuator mechanism  240  such that the portion of the actuator mechanism  240  is movably disposed within the inner volume  211 . Furthermore, the inner volume  211  is configured to define the second fluid reservoir  290 , as further described herein. The distal end portion  203  of the housing  201  includes a port  205 . In some embodiments, the port  205  can be monolithically formed with the housing  201  (e.g., as shown in  FIGS.  2 - 6   ). In other embodiments, the port  205  can be coupled to the distal end portion  203  in any suitable manner such as, for example, via a friction fit, a threaded coupling, a mechanical fastener, an adhesive, any number of mating recesses, and/or any combination thereof. 
     The port  205  can be any suitable shape, size, or configuration. For example, in some embodiments, at least a portion of the port  205  can form a lock mechanism configured to be physically and fluidically coupled to a needle, a cannula, or other lumen-containing device. For example, in some embodiments, the port  205  can be a Luer-Lok® or similar locking mechanism configured to physically and fluidically couple to a needle or cannula assembly (not shown in  FIGS.  2 - 6   ). In other embodiments, the port  205  can be monolithically formed with at least a portion of the lumen-containing device. In this manner, the port  205  can be placed in fluid communication with a lumen defined by the lumen-defining device and to receive the bodily-fluid from a patient when the lumen-defining device is disposed within the patient (e.g., as a result of a venipuncture event), as further described herein. 
     As described above, the actuator mechanism  240  is disposed within the inner volume  211  and is movable between a first position (e.g., a distal position relative to the housing  201 ) and a second position (e.g., a proximal position relative to the housing  201 ). Furthermore, the movement of the actuator mechanism  240  relative to the housing  201  can move the transfer device  200  between a first, second, and third configuration, as further described herein. The actuator mechanism  240  includes a first member  241  and a second member  251 . The first member  241  of the actuator mechanism  240  includes a proximal end portion  242  and a distal end portion  243  and defines an inner volume  246  therebetween. At least a portion of the inner volume  246  is configured to define the first reservoir  280 , as further described herein. 
     The proximal end portion  242  is substantially open such that at least a portion of the second member  251  can be movably disposed within the inner volume  246 . The proximal end portion  242  also includes a protrusion  244  that extends from an inner surface of a wall (or set of walls) defining the inner volume  246  and is configured to selectively engage a portion of the second member  251 . 
     The distal end portion  243  of the first member  241  includes a plunger  247 . The plunger  247  is configured to form a friction fit with the inner surface of the walls defining the inner volume  211  when the actuator mechanism  240  is disposed within the housing  201 . Similarly stated, the plunger  247  defines a fluidic seal with the inner surface of the walls defining the inner volume  211  such that a portion of the inner volume  211  proximal of the plunger  247  is fluidically isolated from a portion of the inner volume  211  distal of the plunger  247 . The plunger  247  is further configured to define a channel  248  that extends though a distal end and a proximal end of the plunger  247 . Moreover, a portion of an inner set of walls defining the channel  248  is configured to form a valve seat  249 . In this manner, a portion of the channel  248  can receive a valve  270  that is in contact with the valve seat  249 . 
     The valve  270  can be any suitable valve. For example, in some embodiments, the valve  270  is a one-way check valve configured to allow a flow of a fluid from a distal end of the valve  270  to a proximal end of the valve  270  but substantially not allow a flow of the fluid from the proximal end to the distal end. In addition, the valve  270  can be disposed within the channel  248  and can be in contact with the valve seat  249  such that the valve  270  forms a substantially fluid tight seal with the walls defining the channel  248 . In some embodiments, the valve  270  can form a first fit with walls defining the channel  248 . In other embodiments, the valve  270  can form a threaded coupling or the like with at least a portion of the walls. The valve  270  can also include a seal member configured to engage the valve seat  249  thereby forming at least a portion of the fluid tight seal. The arrangement of the plunger  247  and the valve  270  is such that when the valve  270  is in the open configuration, the inner volume  246  defined by the first member  241  is placed in fluid communication with the portion of the inner volume  211  of the housing  201  that is distal of the plunger  247 , as further described herein. 
     The second member  251  of the actuator mechanism  240  includes a proximal end portion  252  and a distal end portion  253 . The proximal end portion  252  includes an engagement portion  258  that can be engaged by a user (e.g., a phlebotomist, a nurse, a technician, a physician, etc.) to move at least a portion of the actuator mechanism  240  relative to the housing  201 . The distal end portion  253  includes a plunger  257  configured to form a friction fit with the inner surface of the walls defining the inner volume  246  when the second member  251  is disposed with the first member  241 . Similarly stated, the plunger  257  defines a fluidic seal with the inner surface of the walls defining the inner volume  246  such that a portion of the inner volume  246  proximal of the plunger  257  is fluidically isolated from a portion of the inner volume  246  distal of the plunger  257 . 
     As described above, at least a portion the second member  251  is configured to be movably disposed within the inner volume  246  of the first member  241 . More specifically, the second member  251  can be movable between a first position (e.g., a distal position) and a second position (e.g., a proximal position) thereby moving the actuator mechanism  240  between a first configuration and a second configuration, respectively. In addition, the second member  251  includes a protrusion  254  that extends in a radial direction to selectively engage the protrusion  244  of the first member  241 . In this manner, the protrusion  244  of the first member  241  and the protrusion  254  of the second member  251  can be placed in contact to substantially limit a proximal movement of the second member  251  relative the first member  241 . 
     In use, a user can engage the transfer device  200  to couple the port  205  to a proximal end portion of a lumen-defining device (not shown) such as, for example, a butterfly needle, a cannula assembly, a trocar (which is some cases is used to insert a catheter into a patient), or the like. With the port  205  physically coupled to the lumen-defining device, the port  205  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 port  205  is placed in fluid communication with the portion of the body. 
     With the port  205  coupled to the lumen-defining device, a user (e.g., a phlebotomist, a nurse, a technician, a physician, or the like) can move the transfer device  200  from the first configuration to the second configuration. More specifically, the user can engage the engagement portion  258  of the second member  251  included in the actuator mechanism  240  to move the actuator mechanism  240  from its first configuration to its second configuration, thereby placing the transfer device  200  in the second configuration, as indicated by the arrow AA in  FIG.  5   . In this manner, the second member  251  of the actuator mechanism  240  is moved in a proximal direction relative to the first member  241  (e.g., the first member  241  does not substantially move in the proximal direction) until the protrusion  254  of the second member  251  is placed into contact with the protrusion  244  of the first member  241 . 
     The arrangement of the second member  251  within the first member  241  is such that the proximal motion of the second member  251  increases the volume of the portion of the inner volume  246  that is distal of the plunger  257 , thereby defining the first reservoir  280 . Furthermore, with the plunger  257  forming a fluid tight seal with the inner surface of the walls defining the inner volume  246 , the increase of volume can produce a negative pressure within the first reservoir  280 . 
     As shown by the arrow BB in  FIG.  5   , the port  205 , the valve  270 , and the channel  248  define a fluid flow path that places the first reservoir  280  in fluid communication with the lumen-defining device. Therefore, the first reservoir  280  is placed in fluid communication with the portion of the patient (e.g., the vein). Expanding further, the negative pressure within the first reservoir  280  can be operative in moving the valve  270  from a closed configuration to an open configuration. In this manner, the negative pressure within the within the first reservoir  280  produced by the movement of the plunger  257  introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port  205  and the valve  270  and into the first reservoir  280 . In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes and/or other external contaminants. 
     In some embodiments, the magnitude of the suction force can be modulated by increasing or decreasing the amount of a 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 engagement portion  258  of the second member  251 . In this manner, the rate of change (e.g., the increase) in the volume of the first reservoir  280  can be sufficiently slow to allow time for the negative pressure differential between the vein and the fluid reservoir to come to equilibrium before further increasing the volume of the first reservoir  280 . Thus, the magnitude of the suction force can be modulated. 
     While in the second configuration, the transfer device  200  can be configured to transfer a desired amount (e.g., a predetermined amount) of bodily-fluid transferred to the first reservoir  280 . In some embodiments, the first, predetermined amount can substantially correspond to the size of the first reservoir  280 . In other embodiments, the first amount can substantially correspond to an equalization of pressure within the first reservoir  280  and the portion of the patient. Moreover, in such embodiments, the equalization of the pressure can be such that the valve  270  is allowed to return to the closed configuration. Thus, the first reservoir  280  is fluidically isolated from a volume substantially outside the first reservoir  280 . 
     With the first amount fluidically isolated, the actuator mechanism  240  can be moved from the second configuration to a third configuration by further moving the actuator mechanism  240  in the proximal direction. For example, as indicated by the arrow CC in  FIG.  6   , the user can apply a force to the engagement portion  258  of the second member  251  to move the actuator mechanism  240  relative to the housing  201 . Expanding further, with the protrusion  254  of the second member  251  in contact with the protrusion  244  of the first member  241 , the further application of force on the engagement portion  258  is such that the first member  241  and the second member  251  collectively move in the proximal direction relative to the housing  201 . 
     The arrangement of the first member  241  within the inner volume  211  of the housing  201  is such that the proximal motion of the first member  241  increases the volume of the portion of the inner volume  211  that is distal of the plunger  247 , thereby defining the second reservoir  290 . Furthermore, with the plunger  247  forming a fluid tight seal with the inner surface of the walls defining the inner volume  211  and with the valve  270  in the closed configuration, the increase of volume can produce a negative pressure within the second reservoir  290 . 
     As shown by the arrow DD in  FIG.  6   , the port  205  and a portion of the inner volume  211  define a fluid flow path that places the second reservoir  290  in fluid communication with the lumen-defining device. Therefore, the second reservoir  290  is placed in fluid communication with the portion of the patient (e.g., the vein). Expanding further, the negative pressure within the second reservoir  290  produced by the movement of the plunger  247  introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port  205  and into the second reservoir  290 . In addition, the bodily-fluid contained within the second reservoir  290  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). 
     While not shown in  FIGS.  2 - 6   , the actuator mechanism  240  can be moved from the third configuration to a fourth configuration to place the transfer device  200  in a fourth configuration. For example, in some embodiments, with the desired amount of bodily-fluid disposed within the second fluid reservoir  290 , the transfer device  200  can be removed from the portion of the patient and disposed above or in a container (e.g., a vile, a test tube, a petri dish, a culture medium, a test apparatus, a cartridge designed for use with an automated, rapid microbial detection system, or the like) such that at least a portion of the second amount of bodily-fluid can be tested. The withdrawn bodily-fluid can be used for any number of testing processes or procedures such as, for example, blood culture testing, real-time diagnostics, and/or PCR-based approaches. Expanding further, the user can apply a force to the engagement portion  258  of the second member  251  to move the actuator mechanism  240  in the distal direction (e.g., opposite the arrow CC shown in  FIG.  6   ). With the valve  270  in the closed configuration the bodily-fluid contained within the first reservoir  280  is maintained in fluid isolation with a volume outside the first reservoir  280 . In some embodiments, the volume of the first reservoir  280  is sufficient to contain the first centiliter or few centiliters of bodily-fluid. In other embodiments, the first reservoir  280  can be configured to contain from about 0.1 ml to about 3.0 ml. In still other embodiments, the first reservoir  280  can be configured to contain from about 3.0 ml, 4.0 ml, 5.0 ml, 6.0 ml, 7.0 ml, 8.0 ml, 9.0 ml, 10.0 ml, 15.0 ml, 20.0 ml, 25.0 ml, 50 ml, or any volume or fraction of volume therebetween. Furthermore, the pressure within the first reservoir  280  can be such that the force applied to the second member  251  does not substantially move the second member  251  relative to the first member  241 . Thus, the force applied to the engagement portion  258  collectively moves the second member  251  and the first member  241  in the distal direction relative to the housing  201  to expel a desired portion of the second amount of bodily-fluid from the lumen-defining device and into the container. 
     Although not shown in  FIGS.  2 - 6   , in some embodiments, the syringe-based transfer device  200  can be coupled to a device in fluid communication with the patient that is also configured to reduce contamination of a patient sample. For example, in some embodiments, the syringe-based transfer device  200  can be used with a lumenless needle or the like such as those described in the &#39;758 application. 
       FIGS.  7 - 10    illustrate a syringe-based transfer device  300  according to an embodiment. The syringe-based transfer device  300  (also referred to herein as “bodily-fluid transfer device,” “fluid transfer device,” or “transfer device”) is configured to be moved between a first, second, third, and fourth configuration, as further described herein. The transfer device  300  includes a housing  301  and an actuator  341 . Furthermore, the transfer device  300  is configured to include or define a first fluid reservoir  380  (also referred to herein as “first reservoir” or “pre-sample reservoir”) and a second fluid reservoir  390  (also referred to herein as “second reservoir” or “sample reservoir”). The transfer device  300  can be any suitable shape, size, or configuration. For example, while shown in  FIGS.  7  and  8    as being substantially cylindrical, the transfer device  300  can be square, rectangular, polygonal, and/or any other non-cylindrical shape. Moreover, portions of the transfer device  300  can be substantially similar to the corresponding portions of the transfer device  200 , described above in reference to  FIGS.  2 - 6   . Therefore, such portions are not described in further detail herein and should be considered substantially similar unless explicitly described differently. 
     As shown in  FIGS.  7  and  8   , the housing  301  includes a proximal end portion  302  and a distal end portion  303  and defines an inner volume  311  therebetween. The proximal end portion  302  of the housing  301  is substantially open and is configured to receive at least a portion of the actuator  341  such that the portion of the actuator  341  is movably disposed within the inner volume  311 . Furthermore, the inner volume  311  is configured to define the second fluid reservoir  390 , as further described herein. The distal end portion  303  of the housing  301  includes a port  305 . The port  305  is configured to be coupled to or monolithically formed with a lumen-containing device, such as those described above. 
     As described above, the actuator  341  is disposed within the inner volume  311  and is movable between a first position (e.g., a distal position relative to the housing  301 ) and a second position (e.g., a proximal position relative to the housing  301 ). The actuator  341  includes a proximal end portion  342  and a distal end portion  343  and defines an inner volume  346  therebetween. The proximal end portion  342  includes an engagement portion  350 , as described above with respect to the second member  251  of the actuator mechanism  240 . In addition, the proximal end  342  is substantially open such that at least a portion of the first reservoir  380  can be movably disposed within the inner volume  346 . 
     The distal end portion  343  of the actuator  341  includes a plunger  347 . The plunger  347  is configured to form a friction fit with the inner surface of the walls defining the inner volume  311  when the actuator  341  is disposed within the housing  301 , as described in detail above in reference  FIGS.  2 - 6   . The plunger  347  also defines a channel  348  that extends though a distal end and a proximal end of the plunger  347 . The channel  348  is configured to receive a port  375  having a base  376  and a piercing member  377 . The base  376  can be disposed within the channel  348  and forms a friction fit with a set walls defining the channel  348 . In this manner, the base  376  and the walls defining the channel  348  can form a substantially fluid tight seal. The piercing member  377  of the port  375  is configured to extend in the proximal direction from the base  376 . As shown in  FIG.  8   , the piercing member  377  can be disposed within a sheath configured to be selectively moved to expose, for example, a needle. For simplicity,  FIGS.  8 - 10    only illustrate a sheath of the piercing member and not the needle disposed therein. 
     A portion of the set of walls defining the channel  348  is configured to form a valve seat  349 . In this manner, a portion of the channel  348  can receive a valve  370  such that the valve  370  is in contact with the valve seat  349 . The valve  370  can be any suitable configuration, for example, the valve  370  can be similar in form and function to the valve  270  described above. In this manner, the arrangement of the plunger  347  and the valve  370  is such that when the valve  370  is in the open configuration, the port  375  is placed in fluid communication with the portion of the inner volume  311  of the housing  301  that is distal of the plunger  347 , as further described herein. 
     In use, a user can engage the transfer device  300  to couple the port  305  to a proximal end portion of a lumen-defining device (not shown) such as, for example, a butterfly needle, a cannula assembly, a trocar (which in some cases is used to insert a catheter into a patient), or the like. With the port  305  physically coupled to the lumen-defining device, the port  305  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 port  305  is placed in fluid communication with the portion of the body. 
     With the port  305  coupled to the lumen-defining device, a user (e.g., a phlebotomist, a nurse, a technician, a physician, or the like) can move the transfer device  300  from the first configuration to the second configuration. In this manner, the user can engage the first reservoir  380  and place the first reservoir  380  within the inner volume  346  defined by the actuator  341 . More specifically, as shown in  FIG.  8   , the first reservoir  380  can be an external fluid reservoir configured to receive a fluid. For example, in some embodiments, the first reservoir  380  can be a Vacutainer® and/or a monolithically formed chamber in the transfer device  300  with or without a negative pressure. In other embodiments, the first reservoir  380  can be a pre-sample reservoir such as those disclosed in the &#39;420 patent. In this manner, the first reservoir  380  can be placed within the inner volume  346  of the actuator  341 , as indicated by the arrow EE in  FIG.  9   . 
     The insertion of the first reservoir  380  into the inner volume  346  of the actuator  341  can place the transfer device  300  in the second configuration. Furthermore, the distal end portion of the first reservoir  380  can be configured to include a pierceable septum that can receive the piercing member  377  of the port  375 . While not shown in  FIG.  9   , the distal end portion of the first reservoir  380  can engage the port  375  such that the sheath of the piercing member  377  is moved, thereby exposing the needle. Thus, the needle can pierce the septum of the first reservoir  380  to place the first reservoir  380  in fluid communication with the port  375 . The arrangement of the first reservoir  380  can also be such that the inner volume defined therein is substantially evacuated. Similarly stated, the inner volume of the first reservoir  380  defines a negative pressure. 
     As shown by the arrow FF in  FIG.  9   , the port  305 , the valve  370 , and the port  375  define a fluid flow path such that the first reservoir  380  is in fluid communication with the lumen-defining device. Therefore, the first reservoir  380  is placed in fluid communication with the portion of the patient (e.g., the vein, the spinal cavity, etc.). Expanding further, the negative pressure within the first reservoir  380  can be operative in moving the valve  370  from a closed configuration to an open configuration. In this manner, the negative pressure within the within the first reservoir  380  introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port  305 , the valve  370 , and the port  375  and into the first reservoir  380 . In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes and/or other external contaminants. 
     While in the second configuration, the transfer device  300  can be configured to transfer a desired amount (e.g., a predetermined amount) of bodily-fluid transferred to the first reservoir  380 . In some embodiments, the first, predetermined amount can substantially correspond to an equalization of pressure within the first reservoir  380  and the portion of the patient. Moreover, in such embodiments, the equalization the pressure can be such that the valve  370  is allowed to return to the closed configuration. Thus, the first reservoir  380  is fluidically isolated from a volume substantially outside the first reservoir  380 . 
     With the first amount of bodily-fluid (e.g., the amount containing dermally-residing microbes) fluidically isolated, the first reservoir  380  can be removed from the inner volume  346  of the actuator  341  and discarded. In this manner, the actuator  341  can be moved from the second configuration to a third configuration by moving the actuator  341  in the proximal direction. For example, as indicated by the arrow GG in  FIG.  10   , the user can apply a force to the engagement portion  350  of the actuator  341  to move the actuator  341  relative to the housing  301 . The arrangement of the actuator  341  within the inner volume  311  of the housing  301  is such that the proximal motion of the actuator  341  increases the volume of the portion of the inner volume  311  that is distal of the plunger  347 , thereby defining the second reservoir  390 . Furthermore, with the plunger  347  forming a fluid tight seal with the inner surface of the walls defining the inner volume  311  and with the valve  370  in the closed configuration, the increase of volume can produce a negative pressure within the second reservoir  390 . 
     As shown by the arrow  1111  in  FIG.  10   , the port  305  and a portion of the inner volume  311  define a fluid flow path such that the second reservoir  390  is in fluid communication with the lumen-defining device. Therefore, the second reservoir  380  is placed in fluid communication with the portion of the patient (e.g., the vein, spinal cavity, etc.). Expanding further, the negative pressure within the second reservoir  390  produced by the movement of the plunger  347  introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port  305  and into the second reservoir  390 . In addition, the bodily-fluid contained within the second reservoir  390  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). Although not shown in  FIGS.  7 - 10   , in some embodiments, the syringe-based transfer device  300  can be coupled to a device in fluid communication with the patient that is also configured to reduce contamination of a patient sample. For example, in some embodiments, the syringe-based transfer device  300  can be used with a lumenless needle or the like such as those described in the &#39;758 application. 
     While not shown in  FIGS.  7 - 10   , the actuator  341  can be moved from the third configuration to a fourth configuration to place the transfer device  300  in a fourth configuration. For example, in some embodiments, with the desired amount of bodily-fluid disposed within the second fluid reservoir  390 , the transfer device  300  can be removed from the portion of the patient and disposed above or in a container (e.g., a vile, a test tube, a petri dish, a culture medium, a test apparatus, a cartridge or the like) such that a portion of the second amount of bodily-fluid can be tested. Expanding further, the user can apply a force to the engagement portion  350  to move the actuator  341  in the distal direction. Therefore, with the valve  370  in the closed configuration the force applied to the engagement portion  350  the actuator  341  in the distal direction relative to the housing  301  to expel a desired portion of the second amount of bodily-fluid from the lumen-defining device and into the container. 
     While the embodiments shown above describe an actuator being operative in directing a flow of a bodily-fluid, in some embodiments, a transfer device can include a flow control mechanism configured to direct a flow of the bodily-fluid. For example,  FIGS.  11 - 15    illustrate a syringe-based transfer device  400  according to an embodiment. The syringe-based transfer device  400  (also referred to herein as “bodily-fluid transfer device,” “fluid transfer device,” or “transfer device”) includes a housing  401 , a flow control mechanism  430 , and an actuator mechanism  440 . Furthermore, the transfer device  400  is configured to include or define a first fluid reservoir  480  (also referred to herein as “first reservoir” or “pre-sample reservoir”) and a second fluid reservoir  490  (also referred to herein as “second reservoir” or “sample reservoir”). The transfer device  400  can be any suitable shape, size, or configuration. For example, while shown in  FIGS.  11  and  12    as being substantially cylindrical, the transfer device  400  can be square, rectangular, polygonal, and/or any other non-cylindrical shape. Moreover, portions of the transfer device  400  can be substantially similar to the corresponding portions of the transfer device  200 , described above in reference to  FIGS.  2 - 6   . Therefore, such portions are not described in further detail herein and should be considered substantially similar unless explicitly described differently. 
     As shown in  FIGS.  11  and  12   , the housing  401  includes a proximal end portion  402 , a distal end portion  403 , and defines an inner volume  411  therebetween. The proximal end portion  402  of the housing  401  is substantially open and is configured to receive at least a portion of the actuator mechanism  440  such that the portion of the actuator mechanism  440  is movably disposed within the inner volume  411 . Furthermore, the inner volume  411  is configured to define, at least partially, the first fluid reservoir  480  the second fluid reservoir  490 , as further described herein. 
     The distal end portion  403  of the housing  401  includes a port  405  and a diverter  409 . The port  405  is configured to be coupled to or monolithically formed with a lumen-containing device, such as those described above. The diverter  409  defines a void  408  that movably receives a portion of the flow control mechanism  430 . As shown in  FIG.  13   , the void  408  is in fluid communication with the port  405 . The diverter  409  further defines a first lumen  406  in fluid communication with the void  408  and a first portion of the inner volume  411 , and a second lumen  407  in fluid communication with the void  408  and a second portion of the inner volume  411 . In this manner, the diverter  409  can selectively receive a flow of a bodily-fluid as further described herein. 
     Referring back to  FIG.  12   , the flow control mechanism  430  includes a first member  431  and a second member  435 . As described above, at least a portion of the flow control mechanism  430  is movably disposed within a portion of the housing  401 . More specifically the first member  431  is rotatably disposed within the void  408  of the diverter  409 . The first member  431  defines a first lumen  432  and a second lumen  433  and defines a circular cross-sectional shape. In this manner, the first member  431  can be disposed within the void  408  such that a portion of the first member  431  forms a friction fit with the walls of the diverter  409  defining the void  408 . For example, in some embodiments, the first member  431  is formed from silicone and has a diameter larger than the diameter of the void  408 . In this manner, the diameter of the first member  431  is reduced when the first member  431  is disposed within the void  408 . Thus, the outer surface of the first member  431  forms a friction fit with the inner surface of the walls defining the void  408 . In other embodiments, the first member  431  can be any suitable elastomer configured to deform when disposed within the void  408  of the diverter  409 . 
     The second member  435  is disposed substantially outside the void  408  and can be engaged by a user to rotate the flow control mechanism  430  between a first configuration and a second configuration. In addition, the first member  431  can be coupled to and/or otherwise engage the second member  445 . For example, in some embodiments, the second member  435  can be coupled to the first member  431  via a mechanical fastener and/or adhesive. In other embodiments, the second member  435  and the first member  431  can be coupled in any suitable manner. Therefore, the first member  431  is configured to move concurrently with the second member  435  when the second member  435  is rotated relative to the housing  401 . In this manner, the flow control mechanism  430  can be rotated to place the first lumen  432  or the second lumen  433  in fluid communication with the port  405 , the first lumen  406 , and/or the second lumen  407 , as described in further detail herein. 
     As described above, the actuator mechanism  440  is disposed within the inner volume  411  and is movable between a first position (e.g., a distal position relative to the housing  401 ) and a second position (e.g., a proximal position relative to the housing  401 ). Furthermore, the movement of the actuator mechanism  440  relative to the housing  401  can move the transfer device  400  between a first, second, and third configuration, as further described herein. The actuator mechanism  440  includes a first member  470  and a second member  451 . The first member  470  includes a shunt tube  471  and a plunger  476 . The plunger  476  defines a channel  477  is configured to be movably disposed about the shunt tube  471 . Similarly stated, the shunt tube  471  is disposed within the channel  477 . The plunger  476  can be substantially similar in function to those described in detail above. For example, the plunger  476  can be configured to form a friction fit with a set of walls that define the inner volume  411  of the housing  401 . In this manner, the plunger  476  and the walls defining the inner volume  411  form a substantially fluid tight seal. Similarly, the plunger  476  and the shunt tube  471  form a substantially fluid tight seal. Therefore, the plunger  476  fluidically isolates a portion of the inner volume  411  proximal of the plunger  476  from a portion of the inner volume  411  distal of the plunger  476 . 
     The shunt tube  471  includes a proximal end portion  472  and a distal end portion  473 . The distal end portion  473  is coupled to a portion of the diverter  409  such that a lumen  475  defined by the shunt tube  471  is in fluid communication with the second lumen  407  defined by the diverter  409 . The proximal end portion  472  of the shunt tube  471  includes a protrusion  474  that is configured to engage the plunger  476  to substantially limit a proximal movement of the plunger  476  relative to the shunt tube  471 , as further described herein. 
     The second member  451  of the actuator mechanism  440  includes a proximal end portion  452  and a distal end portion  453 . The proximal end portion  452  includes an engagement portion  458  that can be engaged by a user (e.g., a phlebotomist, a nurse, a technician, a physician, etc.) to move at least a portion of the actuator mechanism  440  relative to the housing  401 . The distal end portion  453  includes a plunger  457  configured to form a friction fit with the inner surface of the walls defining the inner volume  446  when the second member  451  is disposed with the inner volume  411 . Similarly stated, the plunger  457  defines a fluidic seal with the inner surface of the walls defining the inner volume  411  such that a portion of the inner volume  411  proximal of the plunger  457  is fluidically isolated from a portion of the inner volume  411  distal of the plunger  457 . 
     While not shown in  FIGS.  11 - 15   , the second member  451  can be at least temporarily coupled to the plunger  476  of the first member  470 . For example, in some embodiments, the plunger  457  of the second member  451  can include a protrusion configured to be disposed within a groove defined by the plunger  476  of the first member  470 . In this manner, the first member  470  and the second member  451  can be configured to collectively move, at least temporarily, within the housing  401 , and can further be configured to move, at least temporarily, relative to each other. 
     As shown in  FIG.  13   , the distal end portion  453  defines a channel  459  configured to be selectively disposed about a portion of the shunt tube  471 . Expanding further, the channel  459  can be configured to have a diameter that is sufficiently large such that the second member  451  can freely move about the shunt tube  471  (e.g., the shunt tube  471  and the walls defining the channel do not form a substantial friction fit. 
     In use, a user can engage the transfer device  400  to couple the port  405  to a proximal end portion of a lumen-defining device (not shown) such as, for example, a butterfly needle, a cannula assembly, a trocar (which in some cases is used to insert a catheter into a patient), or the like. With the port  405  physically coupled to the lumen-defining device, the port  405  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, spinal column, etc.). In this manner, the port  405  is placed in fluid communication with the portion of the body. 
     With the port  405  coupled to the lumen-defining device, a user (e.g., a phlebotomist, a nurse, a technician, a physician, or the like) can move the transfer device  400  from the first configuration to the second configuration. More specifically, the user can engage the engagement portion  458  of the second member  451  included in the actuator mechanism  440  to move the actuator mechanism  440  from its first configuration to its second configuration, thereby placing the transfer device  400  in the second configuration, as indicated by the arrow II in  FIG.  14   . In this manner, the actuator mechanism  440  is moved in a proximal direction relative to the housing  401   
     The arrangement of the actuator mechanism  440  is such that the proximal motion of the second member  451  moves the plunger  476  of the first member  470  in the proximal direction relative to the shunt tube  471 . Expanding further, the first member  470  can be at least temporarily coupled to the second member  451  such that the first member  470  and the second member  451  move concurrently in the proximal direction relative to the housing  401 . In this manner, the first member  470  moves in the proximal direction until the first member  470  is placed in contact with the protrusion  474  included in the shunt tube  471 . Moreover, the proximal movement of the plunger  476  increases the volume of the portion of the inner volume  411  of the housing  401  that is distal of the plunger  476 , thereby defining the first reservoir  480 , as shown in  FIG.  14   . With the plunger  476  forming a fluid tight seal with the inner surface of the walls defining the inner volume  411  and with the shunt tube  471  about which the plunger  476  is disposed, the volume increase of the portion of the inner volume  411  can produce a negative pressure within the first reservoir  480 . 
     While the transfer device  400  is placed in the second configuration, the flow control mechanism  430  can be maintained in the first configuration. In this manner, first member  431  of the flow control mechanism  430  can be disposed within the void  408  such that the first lumen  432  defined by the flow control mechanism  430  is in fluid communication with the port  405  and in fluid communication with the first lumen  406  defined by the diverter  409 . In this manner, the port  405 , the first lumen  432  defined by the flow control mechanism  430 , and the first lumen  406  defined by the diverter  409  define a fluid flow path that places the first reservoir  480  in fluid communication with the lumen-defining device, as indicated by the arrow JJ in  FIG.  14   . Therefore, the first reservoir  480  is placed in fluid communication with the portion of the patient (e.g., the vein). Expanding further, the negative pressure within the first reservoir  480  produced by the movement of the plunger  476  (as indicated by the arrow II) introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port  405 , the first lumen  432  defined by the flow control mechanism  430 , and the first lumen  406  defined by the diverter  409  and into the fluid reservoir  480 . In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes and/or other external contaminants. 
     In some embodiments, the magnitude of the suction force can be modulated by moving the rotating the flow control mechanism  430  relative to the diverter  409 . The rotation of the flow control mechanism  330  reduces the size of the fluid pathway (e.g., an inner diameter) between the port  405  and the first lumen  432  of the flow control mechanism  430  and the first lumen  406  of the diverter  409  and the first lumen  432  of the flow control mechanism  430 , thereby reducing the suction force introduced into the vein of the patient. 
     With the desired amount of bodily-fluid transferred to the first reservoir  480 , a user can engage the transfer device  400  to move the transfer device  400  from the second configuration to the third configuration. In some embodiments, the desired amount of bodily-fluid transferred to the first reservoir  480  is a predetermined amount of fluid (as described above). In some embodiments, the volume of the first reservoir  480  is sufficient to contain the first centiliter or few centiliters of bodily-fluid. In other embodiments, the first reservoir  480  can be configured to contain from about 0.1 ml to about 3.0 ml. In still other embodiments, the first reservoir  480  can be configured to contain from about 3.0 ml, 4.0 ml, 5.0 ml, 6.0 ml, 7.0 ml, 8.0 ml, 9.0 ml, 10.0 ml, 15.0 ml, 20.0 ml, 25.0 ml, 50 ml, or any volume or fraction of volume therebetween. In some embodiments, the predetermined amount of bodily-fluid (e.g., volume) is at least equal to the combined volume of the port  405 , the first lumen  432  of the flow control mechanism  430 , the first lumen  406  of the diverter  409 , and the lumen-defining device. In other embodiments, the flow control mechanism  430  can be configured to automatically move from the first configuration to the second configuration to divert fluid flow without user intervention. 
     As shown in  FIG.  15   , the transfer device  400  can be moved from the second configuration to the third configuration by rotating the second member  435  of the flow control mechanism  430  relative to the diverter  409 , as indicated by the arrow KK. In this manner, the flow control mechanism  430  is moved to the second configuration, and the first lumen  432  is fluidically isolated from the port  405  and the first lumen  406  of the diverter  409 . Thus, the first reservoir  480  is fluidically isolated from a volume substantially outside the first reservoir  480 . In addition, the second lumen  433  defined by the flow control mechanism  430  is placed in fluid communication with the port  405  and the second lumen  407  defined by the diverter  409 . Therefore, the port  405 , the second lumen  433  of the flow control mechanism  430 , the second lumen  407  of the diverter  409 , and the lumen  475  of the shunt tube  471  define a fluid flow path, as indicated by the arrow LL. 
     With the flow control mechanism  430  placed in the second configuration, the second member  451  of the actuator mechanism  440  can be moved from the second configuration to a third configuration. Expanding further, with the plunger  476  in contact with the protrusion  474  of the shunt  471 , the second member  451  can be moved in the proximal direction to decouple the second member  451  from the plunger  476  (as described above the plunger  476  is at least temporarily coupled to the first member  451 ). In this manner, the second member  451  can be moved in the proximal direction relative to the first member  470 , as indicated by the arrow MM in  FIG.  15   . The proximal movement of the second member  451  relative to the first member  470  increases the volume of the portion of the inner volume  411  that is proximal of the plunger  476  of the first member  470  and distal of the plunger  457  of the second member  451 , thereby defining the second reservoir  490 . 
     With the plunger  476  of the first member  470  and the plunger  457  of the second member  451  forming a fluid tight seal with the inner surface of the walls defining the inner volume  411 , the volume increase of the portion of the inner volume  411  can produce a negative pressure within the first reservoir  490 . Thus, the negative pressure within the second reservoir  490  is such that the negative pressure differential between the second reservoir  490  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 through the port  405 , the second lumen  433  of the flow control mechanism  430 , the second lumen  407  of the diverter  409 , and the lumen  475  defined by the shunt tube  471  and into the second reservoir  490 . Moreover, the bodily-fluid disposed within the second reservoir  490  is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the first reservoir  480 . 
     Although not shown in  FIGS.  11 - 15   , in some embodiments, the syringe-based transfer device  400  can be coupled to a device in fluid communication with the patient that is also configured to reduce contamination of a patient sample. For example, in some embodiments, the syringe-based transfer device  400  can be used with a lumenless needle or the like such as those described in the &#39;758 application. 
     While not shown in  FIGS.  11 - 15   , the actuator mechanism  440  can be moved from the third configuration to a fourth configuration to place the transfer device  400  in a fourth configuration. For example, in some embodiments, with the desired amount of bodily-fluid disposed within the second fluid reservoir  490 , the transfer device  400  can be removed from the portion of the patient and disposed above or in a container (e.g., a vile, a test tube, a petri dish, a culture medium, a test apparatus, or the like) such that a portion of the second amount of bodily-fluid can be tested. Expanding further, the user can apply a force to the engagement portion  458  to move the second member  451  in the distal direction. Therefore, the force applied to the engagement portion  458  moves the second member  451  in the distal direction relative to the housing  301  to expel a desired portion of the second amount of bodily-fluid from the lumen-defining device and into the container. 
       FIG.  16    is a flowchart illustrating a method  1000  of using a syringe-based transfer device to obtain a bodily fluid sample from a patient. The syringe-based transfer device can be any suitable device such as those described herein. Accordingly, the syringe-based transfer device can include a housing having a port configured to be coupled to the patient, and an actuator mechanism movably disposed in the housing. For example, the housing, the port, and the actuator mechanism can be substantially similar to or the same as the housing  201 , the port  205 , and the actuator mechanism  240 , respectively, described above with reference to  FIGS.  2 - 6   . 
     The method  1000  includes establishing fluid communication between the patient and the port of the syringe-based transfer device, at  1001 . For example, the port can be coupled to a proximal end portion of a lumen-defining device such as, for example, a butterfly needle, a cannula assembly, or the like that is in fluid communication with the patient (e.g., at least a distal end portion of the lumen-defining device is disposed in the body of the patient). With the port physically and fluidically coupled to the lumen-defining device, the port is placed in fluid communication with the body. 
     With the port coupled to the lumen-defining device, a user can establish fluid communication between the port and a pre-sample reservoir included in and/or defined by the syringe-based transfer device, at  1002 . For example, the user can move the actuator mechanism from a first configuration to a second configuration, thereby placing the port in fluid communication with the pre-sample reservoir. In some embodiments, the movement of the actuator mechanism can increase an inner volume which, in turn, can produce a negative pressure within the pre-sample reservoir, as described above with reference to the transfer device  200  in  FIG.  5   . As described above, in some embodiments, the syringe-based transfer device can be manipulated to modulate the magnitude of suction force by controlling the movement of the actuator mechanism. In this manner, a first volume of bodily-fluid is transferred to the pre-sample reservoir with the syringe-based transfer device, at  1003 . In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes and/or other external contaminants. 
     The first volume of bodily-fluid can be any suitable volume. For example, in some embodiments, the first volume of bodily-fluid transferred to the pre-sample reservoir can be a predetermined volume. In some embodiments, the first volume can be, for example, 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 first volume can be greater than 50 ml or less than 0.1 ml. In some embodiments, the first volume can substantially correspond to the size of the pre-sample reservoir  280 . Once the first volume of bodily-fluid is transferred to the pre-sample, reservoir, the pre-sample reservoir is fluidically isolated from the port to sequester the first volume of bodily-fluid in the pre-sample reservoir, at  1004 . For example, in some embodiments, the user can move the actuator mechanism and/or otherwise manipulate the syringe-based transfer device to fluidically isolate the pre-sample reservoir. 
     With the first amount fluidically isolated, fluid communication is established between the port and a sample reservoir defined at least in part by the actuator mechanism and the housing of the syringe-based transfer device, at  1005 . For example, in some embodiments, the housing can define an inner volume in which the actuator mechanism is at least partially disposed. In some embodiments, the actuator mechanism can include a seal member or plunger that can form a substantially fluid tight seal with a set of walls defining the inner volume of the housing, thereby defining the sample reservoir. For example, the actuator mechanism and the housing can define the sample reservoir in a similar manner as described above with reference to the actuator mechanism  240 , the housing  201 , and the sample reservoir  290  of  FIG.  6   . As such, the actuator mechanism can be moved from a first position to a second position to draw a second volume of bodily-fluid from the patient into the sample reservoir, at  1006 . With the first volume of bodily-fluid sequestered in the pre-sample reservoir, the second volume of bodily-fluid transferred to the sample reservoir can be substantially free from contaminants such as, for example, dermally residing microbes or the like. 
     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 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. For example, while the flow control mechanism  430  of the transfer device  400  is described above (with reference to  FIG.  15   ) as being moved prior to the second member  451  of the actuator mechanism  440 , in some embodiments, the second member  451  can be moved prior to or concurrently with the flow control mechanism  430 . 
     While various embodiments have been particularly shown and described, various changes in form and details may be made. For example, while the flow control mechanism  430  is shown and described with respect to  FIGS.  11 - 15    as being rotated in a single direction, in other embodiments, a flow control mechanism can be rotated in a first direction (e.g., in the direction of the arrow KK in  FIG.  15   ) 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 flow control mechanism in the second direction can be limited. For example, in some embodiments, the flow control mechanism can be limitedly rotated in the second direction to reduce the diameter of a flow path between the flow control mechanism and a lumen such as to reduce a suction force, as described above. 
     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  400  is shown in  FIGS.  11 - 15    as not including a valve (e.g., such as those described in the transfer devices  200  and  300 ), in some embodiments, the transfer device  400  can include a valve. For instance, the transfer device  400  can include a valve in the first lumen  406  of the diverter  409 , or at any other suitable position. 
     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.