Fluid control device and method of use thereof

Abstract

The apparatus (100) for obtaining a reduced-contamination bodily fluid sample includes a housing (110) having an isolation chamber (130), an inlet (113), and an outlet (114). A flow controller (140) defines a portion of the isolation chamber (130) and is capable of transitioning from a first state, in which the isolation chamber has a first volume, to a second state, in which the isolation chamber has a second volume greater than the first volume, to draw an initial volume of bodily fluid into the isolation chamber (130) in response to suction applied by a fluid collection device (180) fluidly connected to the outlet (114). An actuator (150) is coupled to the housing (110) and is fluidly connected to the inlet (113) and the isolation chamber (130) in the first configuration and transitions to the second configuration to isolate the isolation chamber (130) from the inlet (113) and allow a subsequent volume of bodily fluid to flow from the inlet (113) to the outlet (114).

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No. 62 / 816,477, entitled "Fluid Control Devices and Methods of Using the Same," filed March 11, 2019, the disclosure of which is incorporated by reference in its entirety into this specification. [Background technology]

[0002] background

[0002] The embodiments described herein relate generally to the procurement of samples of bodily fluids, and more particularly to fluid diversion, sequestration and / or isolation devices and methods for obtaining samples of bodily fluids with reduced contaminants, such as skin-resident microorganisms and / or other contaminants external to the source of the bodily fluid.

[0003]

[0003] Healthcare professionals routinely perform various types of microbiological tests and a wide range of other diagnostic tests on patients using parenterally obtained bodily fluids. As advanced diagnostic technologies evolve and improve, the speed, accuracy (both sensitivity and specificity) and value of the information they can provide to clinicians continue to increase. Maintaining the integrity of bodily fluid samples during and / or after collection ensures that analytical diagnostic results represent the in vivo situation of the patient. Examples of diagnostic techniques that rely on high-quality, uncontaminated and / or unadulterated bodily fluid samples include, but are not limited to, microbial detection, molecular diagnostics, gene sequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA), next generation sequencing (NGS), etc.), biomarker identification, etc.

[0004]

[0004] If biological material, including cells and / or other external contaminants outside the intended sample source, is inadvertently included in the sample of bodily fluid being analyzed, the presence of such biological material can result in inaccurate results from such tests. In short, when the purity of the sample of bodily fluid is compromised during the specimen acquisition process, the resulting analytical test results may be inaccurate, distorted, contaminated, false positive, false negative, and / or not representative of the patient's actual condition. Furthermore, these results can lead to clinical decision-making that is incomplete, inaccurate, confusing, uncertain, unreliable, and / or otherwise undesirable.

[0005]

[0005] In some examples, devices and / or systems can be used to reduce the likelihood of contamination, tampering, etc. of a sample of bodily fluid for testing. For example, some known devices can be configured to collect, divert, separate, and / or isolate (e.g., separate) an initial volume of bodily fluid that is relatively likely to contain contaminants, such as skin-resident microorganisms. However, some such devices may be perceived as cumbersome, confusing, difficult to use, inappropriate, or unavailable for a target patient population, etc. Furthermore, some such devices may require training, user observation, intervention by more than one user, and / or may otherwise present challenges that may limit their effectiveness. In some examples, these and / or other challenges may complicate the collection of consistently high-quality samples that are uncontaminated, sterile, uncontaminated, etc., which may further affect the validity of the conclusions of the test results.

[0006]

[0006] Although some known devices and / or systems can be configured to limit the amount of user intervention by passively diverting an initial volume of bodily fluid, some such devices and / or systems may not be able to sufficiently divert, isolate, and / or separate an initial volume of bodily fluid (e.g., a pre-sample volume) that is clinically desired and / or effective. Furthermore, in some instances, the operation of some known devices and / or systems relies on positive pressure (e.g., the patient's blood pressure) applied or provided by a bodily fluid source. However, in some such instances, the positive pressure may be insufficient to provide the desired flow dynamics and / or flow rates that make the use of such devices practical in various clinical settings, such as, for example, emergency rooms and other intensive care settings. Summary of the Invention [Problem to be solved by the invention]

[0007]

[0007] Thus, there is a need for fluid control and / or diversion devices and methods that provide consistent collection of bodily fluids (e.g., from general and / or difficult-to-treat patient populations) and obtain samples of bodily fluids with reduced contaminants, such as skin-resident microorganisms and / or other contaminants external to the source of the bodily fluid. Further, there is a need for devices and methods that include, for example, bodily fluid collection with the assistance of various external energy sources and / or negative pressure. [Means for solving the problem]

[0008] overview

[0008] Described herein are devices and methods for obtaining a sample of a bodily fluid with reduced contaminants, such as skin-resident microorganisms and / or other contaminants external to the bodily fluid. In some embodiments, the apparatus for obtaining a sample of a bodily fluid with reduced contamination includes a housing, an actuator, and a flow controller. The housing forms at least a portion of an isolation chamber and has an inlet configured to be fluidly coupled to a source of bodily fluid and an outlet configured to be fluidly coupled to a fluid collection device. The fluid collection device exerts a suction force within at least a portion of the housing when fluidly coupled to the outlet. The actuator is coupled to the housing and has a first configuration in which the inlet is in fluid communication with the isolation chamber and a second configuration in which the inlet is in fluid communication with the outlet and is fluidly isolated from the isolation chamber. The flow controller is disposed within the housing and defines a portion of the isolation chamber. The flow controller can assume a first state in which the portion of the isolation chamber has a first volume and a second state in which the portion of the isolation chamber has a second volume that is greater than the first volume. When the actuator is in the first configuration, the flow controller is configured to transition from the first state to the second state in response to suction force to draw an initial volume of bodily fluid into the portion of the isolation chamber. The actuator is configured to transition to the second configuration after the initial volume of bodily fluid has been drawn into the isolation chamber to (1) isolate the isolation chamber from the inlet and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to suction force. [Brief description of the drawings]

[0009] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] 1 is a schematic diagram of a fluid control device according to one embodiment. [Diagram 2]

[0010] FIG. 1 is a front perspective view of a fluid control device according to one embodiment. [Diagram 3]

[0010] FIG. 1 is a rear perspective view of a fluid control device according to one embodiment. [Figure 4]

[0011] FIG. 3 is a side view of the fluid control device of FIG. 2. [Diagram 5] FIG. 3 is a top view of the fluid control device of FIG. [Figure 6]

[0012] FIG. 3 is an exploded perspective view of the fluid control device of FIG. 2. [Figure 7]

[0013] 7 is a cross-sectional view of the fluid control device of FIG. 2 taken along line 7-7 of FIG. 4, shown in a first state. [Figure 8] 8 is a cross-sectional view of the fluid control device of FIG. 2 taken along line 8-8 of FIG. 5, shown in a first state. [Figure 9]

[0014] 7 is a cross-sectional view of the fluid control device of FIG. 2 taken along line 7-7 of FIG. 4, shown in a second state. [Figure 10] 8 is a cross-sectional view of the fluid control device of FIG. 2 taken along line 8-8 of FIG. 5, shown in a second state. [Figure 11]

[0015] 8 is a partial cross-sectional view of the fluid control device of FIG. 2 taken along line 8-8 of FIG. 5, shown in a second state. [Figure 12]

[0016] FIG. 1 is a front perspective view of a fluid control device according to one embodiment. [Figure 13] 1 is a rear perspective view of a fluid control device according to one embodiment. [Figure 14]

[0017] FIG. 13 is a side view of the fluid control device of FIG. 12. [Figure 15] FIG. 13 is a top view of the fluid control device of FIG. [Figure 16]

[0018] FIG. 13 is an exploded perspective view of the fluid control device of FIG. 12. [Figure 17]

[0019] 17 is a cross-sectional view of the fluid control device of FIG. 12 taken along line 17-17 of FIG. 14, shown in a first state. [Figure 18] 18 is a cross-sectional view of the fluid control device of FIG. 12 taken along line 18-18 of FIG. 15, shown in a first state. [Figure 19]

[0020] 17 is a cross-sectional view of the fluid control device of FIG. 12 taken along line 17-17 of FIG. 14, shown in a second state. [Figure 20] 18 is a cross-sectional view of the fluid control device of FIG. 12 taken along line 18-18 of FIG. 15, shown in a second state. [Figure 21]

[0021] 18 is a partial cross-sectional view of the fluid control device of FIG. 12 taken along line 18-18 of FIG. 15, shown in a second state. [Figure 22]

[0022] FIG. 1 is a front perspective view of a fluid control device according to one embodiment. [Diagram 23]

[0022] FIG. 1 is a rear perspective view of a fluid control device according to one embodiment. [Figure 24]

[0023] 24 is a cross-sectional view of the fluid control device of FIG. 22 shown in a first state taken along line 24-24. [Diagram 25] 24 is a cross-sectional view of the fluid control device of FIG. 22 shown in a first state taken along line 24-24. [Figure 26]

[0024] 24 is a cross-sectional view of the fluid control device of FIG. 22 shown in a second state taken along line 24-24. [Figure 27] 24 is a cross-sectional view of the fluid control device of FIG. 22 shown in a second state taken along line 24-24. [Figure 28]

[0025] 1 is a flowchart illustrating a method of using a fluid control device according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Detailed Description

[0026] Described herein are devices and methods for collecting, diverting, segregating, separating, etc., an initial volume of bodily fluid to reduce contamination in a subsequently acquired sample of the bodily fluid. Any of the fluid control devices described herein can be configured to receive, acquire, and / or transfer a flow, bolus, volume, etc. of bodily fluid. A first reservoir, channel, flow path, or portion of the device can receive an initial amount of the bodily fluid flow and thereafter substantially or completely segregate (e.g., contain or hold, divert, separate, segregate, vapor-lock, isolate, etc.) such bodily fluid flow therein. In some examples, the initial amount of bodily fluid may contain and / or be contaminated with contaminants, such as skin-resident microorganisms, which are likewise segregated within or by the first reservoir or first portion of the device. Once the initial amount is segregated, any subsequent amount of the bodily fluid flow may be diverted, channeled, directed, and / or otherwise allowed to flow to or through a second portion of the device and / or any additional flow paths. Based at least in part on the initial volume that is sequestered, the subsequent volume of bodily fluid can be substantially free of contaminants that may otherwise result in inaccurate, distorted, adulterated, and / or erroneous results in some diagnoses and / or tests. In some examples, the initial volume of bodily fluid can also be used in other tests, such as those that are less affected by the presence of contaminants, can be discarded as waste, can be infused back into the patient's body, and / or can be used for any other suitable clinical application.

[0011]

[0027] In some embodiments, a feature of the fluid control devices and / or methods described herein is the use of an external negative pressure source (e.g., provided by a fluid collection device or any other suitable means) that can (1) overcome physical patient issues that may limit and / or prevent a sufficient pressure differential (e.g., blood pressure difference relative to ambient air pressure) to fully activate the isolation chamber and / or transfer fluid flow to the fluid collection device, (2) ensure that the isolation chamber is properly filled with a clinically validated and / or desired volume of bodily fluid, (3) provide efficient, timely and / or user-acceptable consistency with the bodily fluid collection process, and / or (4) provide a means to transfer fluid flow (e.g., automatically or by manipulating any number of physical components of the system to move, or by altering, switching, actuating and / or otherwise providing desired fluid flow dynamics) to enable isolation and / or separation of an initial volume (e.g., a pre-sample volume) and subsequent collection of the sample.

[0012]

[0028] In some embodiments, for example, an apparatus for obtaining a sample of a bodily fluid with reduced contamination includes a housing, an actuator, and a flow controller. The housing forms at least a portion of an isolation chamber and has an inlet configured to be fluidly coupled to a source of bodily fluid and an outlet configured to be fluidly coupled to a fluid collection device. The fluid collection device exerts a suction force within at least a portion of the housing when fluidly coupled to the outlet. The actuator is coupled to the housing and has a first configuration in which the inlet is in fluid communication with the isolation chamber and a second configuration in which the inlet is in fluid communication with the outlet and is fluidly isolated from the isolation chamber. The flow controller is disposed within the housing and defines a portion of the isolation chamber. The flow controller has a first state in which the portion of the isolation chamber has a first volume and a second state in which the portion of the isolation chamber has a second volume that is greater than the first volume. When the actuator is in the first configuration, the flow controller transitions from the first state to the second state in response to the suction force to draw an initial volume of bodily fluid into the portion of the isolation chamber. The actuator is configured to transition to a second configuration after an initial volume of bodily fluid is drawn into the isolation chamber to (1) isolate the isolation chamber from the inlet and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to a suction force.

[0013]

[0029] In some embodiments, an apparatus for obtaining a sample of a bodily fluid with reduced contamination includes a housing, an actuator, and a flow controller. The housing forms at least a portion of an isolation chamber and has an inlet configured to be fluidly coupled to a source of bodily fluid and an outlet configured to be fluidly coupled to a fluid collection device. The fluid collection device exerts a suction force within at least a portion of the housing when fluidly coupled to the outlet. The actuator is coupled to the housing and has a first configuration in which the inlet is in fluid communication with the isolation chamber and a second configuration in which the inlet is in fluid communication with the outlet and is fluidly isolated from the isolation chamber. The flow controller is disposed within the housing and defines a portion of the isolation chamber. The flow controller has a first state in which a first side of the flow controller contacts at least a portion of a first surface of the isolation chamber and a second state in which a second side of the flow controller contacts at least a portion of a second surface of the isolation chamber opposite the first surface. The flow controller transitions from the first state to the second state as a result of application of a suction force to the second side of the flow controller when the actuator is in the first configuration to draw an initial volume of bodily fluid into a portion of the isolation chamber defined between the first surface and the first side of the flow controller, and the actuator is configured to transition to the second configuration after the initial volume of bodily fluid is drawn into the isolation chamber to (1) isolate the isolation chamber from the inlet and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force.

[0014]

[0030] In some embodiments, the fluid control device includes a housing, an actuator, and a flow controller. The housing has an inlet and an outlet, forming an isolation chamber. The inlet is configured to be placed in fluid communication with a source of bodily fluid. The outlet is configured to be placed in fluid communication with a fluid collection device configured to apply a suction force within at least a portion of the housing. The actuator is coupled to the housing and configured to isolate fluid communication between the inlet and the isolation chamber when in a first state and establish fluid communication between the inlet and the outlet when in a second state. The flow controller is disposed within the isolation chamber and configured to transition from the first state to a second state in response to the suction force when the actuator is in the first state to allow an initial volume of bodily fluid to flow into a portion of the isolation chamber. The portion of the isolation chamber has a first volume when the flow controller is in the first state and a second volume greater than the first volume when the flow controller is in the second state. The actuator is configured to transition to its second configuration after an initial volume of bodily fluid is received within the portion of the isolation chamber to (1) isolate the isolation chamber and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to a suction force.

[0015]

[0031] In some embodiments, a method of obtaining a sample of bodily fluid with reduced contamination using a fluid control device having a housing, an actuator, and a flow controller includes establishing fluid communication between a bodily fluid source and an inlet of the housing. A fluid collection device is coupled to an outlet of the housing and applies a suction force within at least a portion of the housing when coupled to the outlet. The flow controller transitions from a first state to a second state in response to the suction force to increase a volume of an isolation chamber collectively defined by the flow controller and the portion of the housing. In response to the increase in volume, the first portion of the isolation chamber receives a volume of air contained within a flow path defined between the bodily fluid source and the isolation chamber, and the second portion of the isolation chamber receives an initial volume of bodily fluid. The actuator transitions from the first form to the second form after receiving the initial volume of bodily fluid in the second portion of the isolation chamber to (1) isolate the isolation chamber and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force.

[0016]

[0032] In some embodiments, a method of obtaining a sample of bodily fluid with reduced contamination using a fluid control device having a housing, a flow controller, and an actuator can include, for example, establishing fluid communication between a bodily fluid source and an inlet of the housing. A fluid collection device is fluidly coupled to an outlet of the housing. The flow controller transitions from a first state to a second state in response to a suction force applied by the fluid collection device to increase a volume of a first portion of the isolation chamber and a second portion of the isolation chamber. The first portion of the isolation chamber receives a volume of air contained within a flow path defined between the bodily fluid source and the isolation chamber in response to the increase in the volume of the first portion of the isolation chamber and the second portion of the isolation chamber. The second portion of the isolation chamber receives an initial volume of bodily fluid in response to the increase in the volume of the first portion of the isolation chamber and the second portion of the isolation chamber. After receiving the initial volume of bodily fluid in the second portion of the isolation chamber, the actuator transitions from a first form to a second form to (1) isolate the isolation chamber and (2) allow a subsequent volume of bodily fluid (e.g., a sample of bodily fluid) to flow from the inlet to the outlet in response to the suction force.

[0017]

[0033] Any of the embodiments and / or methods described herein can be used to obtain a sample of bodily fluid, such as, for example, a blood sample, that is uncontaminated or substantially free of contaminants. In some examples, a sample of bodily fluid (e.g., a blood sample) can be tested for the presence of one or more potentially undesirable microorganisms, such as bacteria (e.g., gram-positive and / or gram-negative bacteria), fungi, yeast (e.g., Candida), etc. During diagnostic testing, various techniques can be employed to help detect the presence of microorganisms as well as other types of biological material, cells of a given type, biomarkers, proteins, antigens, enzymes, blood components, etc. Examples include, but are not limited to, molecular polymerase chain reaction (PCR), magnetic resonance and other magnetic analysis platforms, automated microscopy, spatial clonal isolation, flow cytometry, whole blood ("non-cultured") specimen analysis (e.g., NGS) and related techniques, morphokinetic cell analysis, and / or other common or evolving advanced techniques to characterize patient specimens and / or detect, identify, classify, classify, and / or characterize given organisms, antibiotic susceptibility, and / or the like.

[0018]

[0034] For example, in some instances, microbiology testing can include culturing a patient sample in one or more containers that can contain media (e.g., nutrient-rich and / or environmentally controlled media that promote growth, and / or other suitable media), general additives, and / or other types of solutions that contribute to microbial growth. Any microorganisms and / or organisms present in the patient sample will flourish and / or grow in the media over time (e.g., for a variable amount of time, from less than an hour to more than several days (which may be shorter or longer depending on the diagnostic technique employed)). The presence of the microorganisms and / or organisms can be detected (e.g., by observation of carbon dioxide levels and / or other detection methods) using automated continuous monitoring and / or other methods specific to the analytical platform or technique used for detection, identification, etc. The presence of the microorganisms and / or organisms in the media is indicative of the presence of the same microorganisms and / or organisms in the patient sample, which in turn is indicative of the presence of the same microorganisms and / or organisms in the patient's bodily fluid from which the sample was obtained. In other examples, samples of bodily fluids can be analyzed directly (i.e., not cultured) for the presence of microorganisms and / or organisms. If microorganisms are determined to be present in the sample used for testing, the patient can be diagnosed and prescribed one or more antibiotics or other treatments specifically designed to treat or otherwise remove the undesirable microorganisms and / or organisms from the patient.

[0019]

[0035] However, patient samples may be contaminated during acquisition and / or may be otherwise prone to erroneous results. For example, microorganisms from the body surface (e.g., skin-resident microorganisms) that are shed during the specimen acquisition process (e.g., directly or indirectly via tissue fragments, hair follicles, sweat glands, and other skin appendage structures) may then be transferred with the patient sample to a culture medium, test bottle, or other suitable specimen collection or transfer container, and / or otherwise included in the specimen to be analyzed. Another possible source of contamination is from the person drawing the patient sample. For example, the equipment, supplies, and / or devices used during the patient sample acquisition process often include multiple fluid interfaces (e.g., patient-to-needle, needle-to-transfer adapter, transfer adapter-to-sample container, catheter hub-to-syringe, syringe-to-transfer adapter, needle / tube-to-sample container, and / or any other fluid interface, or any combination thereof), each of which may introduce a potential contamination point. In some instances, such contaminants may grow in the culture medium and / or be otherwise identified, thereby increasing the risk or likelihood of false positive microbiological test results, which may not accurately reflect the presence or absence of such microorganisms within the patient's body (i.e., in vivo).

[0020]

[0036] Such inaccurate results due to contamination and / or adulteration are problematic when attempting to diagnose or treat a wide range of suspected illnesses, diseases, infections, patient conditions and / or other diseases. For example, erroneous results from microbiology testing may result in a patient being unnecessarily subjected to one or more antimicrobial therapies and / or may lead to a misdiagnosis and / or delay in treatment of a patient's illness, any of which may result in serious adverse effects or consequences for the patient, including, for example, death. Thus, erroneous results may cause unnecessary burdens and costs to the healthcare system due to prolonged patient hospitalization and / or other complications associated with incorrect treatment. The use of diagnostic imaging equipment to reach these erroneous results is also problematic from both a cost standpoint and a patient safety standpoint, as unnecessary exposure to concentrated radiation associated with various imaging procedures (e.g., CT scans) has many known adverse effects on long-term patient health.

[0021]

[0037] As used in this specification and / or any claims contained herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "an element" is intended to mean a single element or combination of elements, "a material" is intended to mean one or more materials, and so forth.

[0022]

[0038] "Body fluid" as used herein can include any fluid obtained directly or indirectly from a patient's body. For example, "body fluid" can include, but is not limited to, blood, cerebrospinal fluid, urine, bile, lymphatic fluid, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air, and the like, or any combination thereof.

[0023]

[0039] As used herein, the terms "proximal" and "distal" refer to directions toward and away from a user who contacts the device with a patient. Thus, for example, the end of the device that first contacts the patient's body would be the distal end of the device, and the opposite end of the device (e.g., the end of the device that is manipulated by the user) would be the proximal end of the device.

[0024]

[0040] As used herein, the terms "about," "approximately," and "substantially," when used in connection with a stated value and / or geometric structure or relationship, are intended to mean that the value or feature so defined is nominally the stated value or described feature. In some instances, the terms "about," "approximately," and / or "substantially" can generally mean and / or generally contemplate a stated value or feature within a desired tolerance range (e.g., ±10% of the stated value or feature). For example, a value of about 0.01 can include 0.009 and 0.011, a value of about 0.5 can include 0.45 and 0.55, a value of about 10 can include 9-11, and a value of about 1000 can include 900-1100. Similarly, if a first surface and a second surface are nominally parallel, the first surface can be said to be substantially parallel to the second surface. It should be understood that while the stated values, structures and / or relationships may be desirable, some variations may occur, for example, as a result of manufacturing tolerances or other practical considerations (e.g., pressure or force exerted through a portion of a device, conduit, lumen, etc.). Accordingly, the terms "about," "approximately," and / or "substantially" may be used herein to account for such tolerances and / or considerations.

[0025]

[0041] As used herein, the terms "pre-sample", "first" and / or "initial" can be used interchangeably to describe an amount, portion or volume of bodily fluid that is collected and / or isolated prior to obtaining a "sample" volume. The "pre-sample", "first" and / or "initial" volume can be a predetermined, defined, desired and / or given amount of bodily fluid. For example, the predetermined and / or desired pre-sample volume of bodily fluid can be one drop of bodily fluid, several drops of bodily fluid, about 0.1 milliliters (mL), about 0.2 mL, about 0.3 mL, about 0.4 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 20.0 mL, about 50.0 mL, and / or any volume or any percentage of volume therebetween. In other embodiments, the pre-sample volume can be greater than 50 mL or less than 0.1 mL. In some certain embodiments, the predetermined and / or desired pre-sample volume can be from about 0.1 mL to about 5.0 mL, in other embodiments, the pre-sample volume can be, for example, the combined volume of any number of lumens (e.g., lumens that form at least a portion of a flow path from a source of bodily fluid to an initial collection chamber, portion, reservoir, etc.).

[0026]

[0042] As used herein, the terms "sample," "second," and / or "subsequent" may be used interchangeably to describe, for example, an amount, portion, or volume of bodily fluid used in one or more samples or diagnostic tests. A "sample" volume can be either a random volume or a predetermined or desired volume of bodily fluid collected after collecting, isolating, and / or separating a pre-sample volume of bodily fluid. In some embodiments, a desired sample volume of bodily fluid can be from about 10 mL to about 60 mL. In other embodiments, a desired sample volume of bodily fluid can be less than 10 mL or more than 60 mL. In some embodiments, for example, a sample volume can be based at least in part on one or more tests, assays, analyses, and / or processes to be performed on the sample volume.

[0027]

[0043] The embodiments described herein can be configured to transfer bodily fluids substantially free of contaminants to one or more fluid collection devices. In some embodiments, the fluid collection devices can include, but are not limited to, any suitable vessel, container, reservoir, bottle, adapter, dish, vial, syringe, device, diagnostic and / or testing equipment, etc. In some embodiments, the fluid collection devices can be substantially similar to or identical to known sample containers, such as Vacutainer® (from Becton Dickinson and Company (BD)), BacT / ALERT® SN or BacT / ALERT® FA (from Biomerieux, Inc.) and / or any suitable reservoir, vial, microvial, microliter vial, nanoliter vial, container, microcontainer, nanocontainer, etc. In some embodiments, the fluid collection device can be substantially similar to or identical to any of the sample reservoirs described in U.S. Patent No. 8,197,420, entitled "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination," filed December 13, 2007 (the "420 Patent"), the disclosure of which is incorporated by reference in its entirety into this specification.

[0028]

[0044] In some embodiments, the fluid collection device can be empty of contents prior to receiving the sample volume of bodily fluid. For example, in some embodiments, the fluid collection device or reservoir can define and / or can be configured to define or generate a vacuum or suction, for example, a vacuum-based collection tube (e.g., Vacutainer®), a syringe, etc. In other embodiments, the fluid collection device can include any suitable additives, media, substances, enzymes, oils, fluids, etc. For example, the fluid collection device can be a sample or culture bottle, for example, containing an aerobic or anaerobic medium. The sample or culture bottle can be configured to receive a sample of bodily fluid that can be tested (e.g., via culture followed by an in vitro diagnostic (IVD) test and / or any other suitable test) for the presence of, for example, gram-positive bacteria, gram-negative bacteria, yeast, fungi, and / or any other organisms. In some examples, if testing of such a medium yields a positive result, the medium can then be tested using a PCR-based system to identify the given organism. In some embodiments, the sample reservoir can include, for example, any suitable additives, etc. in addition to or instead of the medium. Such additives may include, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, sodium polyanethol sulfonate (SPS), etc. In some embodiments, the fluid collection device may include any suitable additive or medium, and the fluid collection device may be evacuated and / or otherwise purged of air.

[0029]

[0045] While the term "media" can be used to describe a substance configured to react with an organism in a bodily fluid (e.g., a microorganism such as bacteria) and the term "additive" can be used to describe a substance configured to react with a portion of the bodily fluid (e.g., constituent cells of blood, serum, synovial fluid, etc.), it should be understood that the sample reservoir can include any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Furthermore, when referring to an "additive" in a sample reservoir, it should be understood that the additive can be a medium, such as an aerobic medium and / or an anaerobic medium contained in a culture bottle, an additive, and / or any other suitable substance or combination of substances contained in a culture bottle and / or any other suitable reservoir such as those mentioned above. That is, the embodiments described herein can be used with any suitable fluid reservoir, etc., containing any suitable substance or combination of substances.

[0030]

[0046] The embodiments and / or portions thereof described herein may be formed or constructed from one or more biocompatible materials. In some embodiments, the biocompatible material may be selected based on one or more properties of the constituent material, such as, for example, stiffness, toughness, durometer hardness, bioactivity, etc. Examples of suitable biocompatible materials include metals, glasses, ceramics, or polymers. Examples of suitable metals include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. Polymeric materials may be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactides, polyglycolides, polylactide-co-glycolides (PLGA), polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, and / or blends and copolymers thereof. Examples of non-biodegradable polymers include nylon, polyesters, polycarbonates, polyacrylates, polysiloxanes (silicones), polymers of ethylene vinyl acetate and other acyl-substituted cellulose acetates, non-degradable polyurethanes, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene oxide, and / or blends and copolymers thereof.

[0031]

[0047] The embodiments and / or portions thereof described herein may include components formed from one or more parts, features, structures, etc. When referring to such components, it should be understood that the components may be formed by a single part having any number of sections, regions, parts, and / or features, or may be formed by multiple parts or features. For example, when referring to a structure such as a wall or a chamber, the structure may be considered as a single structure having multiple parts, or as multiple separate substructures that are combined to form the structure. Thus, an integrally constructed structure may include, for example, a set of substructures. Such a set of substructures may include multiple parts that are either continuous or discontinuous with each other. A set of substructures may also be manufactured from multiple articles or components that are manufactured separately and then joined together (e.g., via welding, adhesive, or any suitable method).

[0032]

[0048] Although some of the embodiments are described herein as being used to obtain bodily fluids for one or more culture sample tests, it should be understood that the embodiments are not limited to such use. Any of the embodiments and / or methods described herein can be used to transfer a flow of bodily fluid to any suitable device placed in fluid communication therewith. Thus, although certain examples are described herein, the devices, methods and / or concepts are not intended to be limited to these specific examples.

[0033]

[0049] Referring now to the drawings, FIG. 1 is a schematic diagram of a fluid control device 100 according to one embodiment. Generally, the fluid control device 100 (also referred to herein as a "control device" or "device") is configured to withdraw bodily fluid from within a patient's body. A first portion or amount of withdrawn bodily fluid (e.g., an initial amount) is isolated from a second portion or amount of withdrawn bodily fluid (e.g., a subsequent amount). In some instances, contaminants or the like may be isolated within the first portion or amount, leaving the second portion or amount substantially free of contaminants. The second portion or amount of bodily fluid may then be used as a biological sample in one or more tests (e.g., blood culture tests, etc.), as described in more detail herein. The first portion or amount of bodily fluid may be discarded as waste or may be used in any suitable test that is unlikely to produce erroneous, inaccurate, distorted, inconsistent, or unreliable results as a result of potential contaminants contained therein.

[0034]

[0050] The control device 100 includes a housing 110, a flow controller 140, and an actuator 150. The housing 110 of the device 100 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 110 may have a size based at least in part on an initial amount or volume of bodily fluid configured to be transported and / or sequestered within a portion of the housing 110. In some embodiments, the housing 110 may have a size and / or shape configured to improve ergonomics and / or ease of use associated with the device 100. Additionally, in some embodiments, one or more portions of the housing 110 may be formed from a relatively transparent material configured to allow a user to visually inspect and / or verify the flow of bodily fluid through at least a portion of the housing 110.

[0035]

[0051] The housing 110 has and / or forms an inlet 113, an outlet 114, and an isolation chamber 130. The inlet 113 is configured to fluidly couple to a lumen-containing device, which may further place the housing 110 in fluid communication with a bodily fluid source. For example, the housing 110 may be coupled to and / or include a lumen-containing device (e.g., a butterfly needle, an intravenous (IV) catheter, a peripherally inserted central catheter (PICC), an intermediate lumen-containing device, etc.) that is in fluid communication with the inlet 113 and configured to be placed percutaneously within a patient's body. Thus, bodily fluids may be transferred from a patient and / or other bodily fluid sources to the housing 110 via the inlet 113, as described in more detail herein. The outlet 114 may be in fluid communication with a fluid collection device 180 (e.g., a fluid or sample reservoir, a syringe, an evacuated container, a culture bottle, etc.). As described in further detail herein, the control device 100 can be used and / or operated to selectively transfer a volume of bodily fluid from a bodily fluid source through the inlet 113, the housing 110 and the outlet 114 to the fluid collection device 180.

[0036]

[0052] The housing 110 can define at least a portion of any number of flow paths. For example, as shown in FIG. 1, the housing 110 defines one or more flow paths 115 between the inlet 113 and the isolation chamber 130, and / or one or more flow paths 116 between the inlet 113 and the outlet 114. As described in further detail herein, the control device 100 and / or the housing 110 can be configured to transition between any number of states, operational modes, and / or configurations to selectively control bodily fluid flow through at least one of the flow paths 115 and / or 116. Additionally, the control device 100 and / or the housing 110 can be configured to transition automatically (e.g., based on pressure differential, based on time, electronically, based on saturation of membranes, absorbent materials, and / or barrier materials, etc.) or via intervention (e.g., user intervention, mechanical intervention, etc.).

[0037]

[0053] The isolation chamber 130 is placed in at least temporary fluid communication with the inlet 113 via the flow path 115. As described in more detail herein, the isolation chamber 130 is configured to (1) receive a flow and / or volume of bodily fluid from the inlet 113 and (2) isolate (e.g., separate, decouple, contain, hold, isolate, etc.) the flow and / or volume of bodily fluid therein. The isolation chamber 130 can have any suitable arrangement, such as, for example, those described herein with respect to certain embodiments. However, it should be understood that the control device 100 and / or the housing 110 can have the isolation chamber 130 arranged in any suitable manner, and thus, the isolation chamber 130 is not intended to be limited to what is shown and described herein. For example, in some embodiments, the isolation chamber 130 can be at least partially formed by the housing 110. In other embodiments, the isolation chamber 130 can be a reservoir located and / or disposed within a portion of the housing 110. In other embodiments, the isolation chamber 130 can be formed and / or defined by a portion of the flow path 115. That is, the housing 110 can define one or more lumens and / or include one or more lumen-defining devices configured to receive an initial flow or volume of bodily fluid from the inlet 113, thereby forming and / or functioning as the isolation chamber 130.

[0038]

[0054] The isolation chamber 130 can have any suitable volume and / or fluid capacity. For example, in some embodiments, the isolation chamber 130 can have a volume and / or fluid capacity of about 0.1 mL to about 5.0 mL. In some embodiments, the isolation chamber 130 can have a volume measured in terms of the amount of bodily fluid configured to be transferred within the isolation chamber 130 (e.g., an initial or first amount of bodily fluid). For example, in some embodiments, the isolation chamber 130 can have a volume sufficient to receive an initial volume of bodily fluid on the order of microliters or less of bodily fluid (e.g., a volume on the order of 20 drops of bodily fluid, 10 drops of bodily fluid, 5 drops of bodily fluid, 1 drop of bodily fluid, or any suitable volume therebetween). In other embodiments, the isolation chamber 130 can have a volume sufficient to receive an initial volume of bodily fluid up to, for example, about 5.0 mL, 10.0 mL, 15.0 mL, 10.0 mL, 30.0 mL, 40.0 mL, 50.0 mL, or more. In some embodiments, the isolation chamber 130 can have a volume equal to at least some of the volume of one or more lumens that fluidly connect the isolation chamber 130 to a source of bodily fluid (e.g., the combined volume of the lumens of the needle, the inlet 113, and at least some of the lumens of the flow path 115).

[0039]

[0055] The outlet 114 of the housing 110 is in fluid communication and / or configured to be placed in fluid communication with the flow paths 115 and / or 116. The outlet 114 can be any suitable outlet, opening, port, plug, lock (e.g., luer lock), seal, coupler, valve (e.g., one-way, check valve, duckbill valve, umbrella valve, etc.), etc., and is configured to be physically and / or fluidly coupled to the fluid collection device 180. In some embodiments, the outlet 114 can be integrally formed with the fluid collection device 180. In other embodiments, the outlet 114 can be at least temporarily coupled to the fluid collection device 180 via adhesive, resistance fit, mechanical fasteners, threaded coupling, drilling or piercing configuration, multiple mating recesses, and / or any other suitable coupling or combination thereof. In still other embodiments, the outlet 114 can be operably coupled to the fluid collection device 180 via an intervening structure (not shown in FIG. 1 ), such as a sterile tube. In some embodiments, the configuration of the outlet 114 may be such that the outlet 114 is physically and / or fluidically sealed prior to coupling to the fluid collection device 180. In some embodiments, the outlet 114 may transition from a sealed configuration to an unsealed configuration in response to being coupled to the fluid connection device 180 and / or in response to a negative pressure differential between the environment within the outlet 114 and / or the housing 110 and the environment within the fluid collection device 180.

[0040]

[0056] Although the control device 100 and / or outlet 114 of the housing 110 are described above as being fluidly coupled and / or otherwise fluidly connected to the fluid collection device 180, in other embodiments, the device 100 may be used with any suitable bodily fluid collection device, system, adapter, etc. For example, in some embodiments, device 100 may be used with or in conjunction with any suitable fluid transfer devices and / or adapters, such as those described in U.S. Pat. No. 10,123,783, entitled "Apparatus and Methods for Disinfection of a Specimen Container," filed March 3, 2015 (referred to herein as the "'783 patent"), and / or U.S. Patent Application Publication No. 2015 / 0342510, entitled "Sterile Bodily-Fluid Collection Device and Methods," filed June 2, 2015 (referred to herein as the "'510 publication"), the disclosures of each of the above patents and publications are incorporated by reference in their entirety into this specification.

[0041]

[0057] The fluid collection device 180 may be any suitable device for at least temporarily containing bodily fluid, such as, for example, any of those described in detail above (e.g., evacuated blood collection tubes, sample reservoirs, syringes, culture bottles, etc.). In some embodiments, the fluid collection device 180 may be a sample reservoir including a vacuum seal that maintains a negative pressure (vacuum) condition within the sample reservoir, thereby facilitating the withdrawal of bodily fluid from the patient through the control device 100 and into the sample reservoir via vacuum or suction. In embodiments in which the fluid collection device 180 is an evacuated blood collection tube or the like, a user may couple the fluid collection device 180 to the outlet 114 to initiate a flow of bodily fluid from the patient into the device 100 such that a first or initial portion of the flow of bodily fluid is transported into and isolated by the isolation chamber 130, and a second or subsequent portion of the flow of bodily fluid is diverted and / or otherwise diverted away from the isolation chamber 130 (e.g., via the outlet 114) and into the fluid collection device 180, as described in more detail herein.

[0042]

[0058] The flow controller 140 of the device 100 is at least partially disposed within the housing 110 and configured to control, direct, and / or otherwise facilitate selective flow of fluid through at least a portion of the housing 110. More specifically, in some embodiments, the flow controller 140 can be disposed within a portion of the isolation chamber 130 that receives an initial flow or amount of bodily fluid and / or an interior volume of the isolation chamber 130 and / or can at least partially define such portion and / or interior volume. In some embodiments, the flow controller 140 can be disposed within the housing 110 such that one or more surfaces of the flow controller 140 and one or more inner surfaces of the housing 110 collectively define the isolation chamber 130. Stated differently, the flow controller 140 can be disposed within the isolation chamber 130 such that an inner surface of the housing 110 that at least partially defines the isolation chamber 130 and one or more surfaces of the flow controller 140 collectively define a portion of the isolation chamber 130 and / or a volume within the isolation chamber 130. In some embodiments, the flow controller 140 may form a barrier and / or otherwise fluidly isolate at least a portion of the flow path 115 from at least a portion of the flow path 116. For example, the flow controller 140 may be disposed within the housing 110 such that a first side and / or a first face of the flow controller 140 is in selective fluid communication with at least a portion of the flow path 115 and / or the inlet 113, and a second side and / or a second face of the flow controller 140 is in selective fluid communication with at least a portion of the flow path 116 and / or the outlet 114.

[0043]

[0059] The flow controller 140 may be of any suitable shape, size, and / or configuration. For example, the flow controller 140 may be, for example, a membrane, a diaphragm, a bladder, a plunger, a piston, a bag, a pouch, and / or any other suitable member having a desired stiffness, flexibility, and / or durometer. In some embodiments, the flow controller 140 may be configured to transition from a first state to a second state in response to a negative pressure differential and / or suction being applied to at least a portion of the flow controller 140. For example, in some embodiments, as described in more detail herein with respect to certain embodiments, the flow controller 140 may be a bladder configured to transition or "flip" from a first state to a second state in response to a negative pressure differential and / or suction being applied to a surface of the bladder.

[0044]

[0060] The flow controller 140 may be in a first state (e.g., a storage or unused state) prior to use of the device 100, and may transition to a second state in response to the outlet 114 being fluidly coupled to a fluid collection device 180 (e.g., a collection device that defines or is configured to define a negative pressure and / or suction). In some embodiments, the flow controller 140 may define at least a portion of the isolation chamber 130 when the flow controller 140 is in the second state. In some embodiments, the arrangement of the flow controller 140 is such that the isolation chamber 130 defines and / or has a first volume when the flow controller 140 is in the first state, and defines and / or has a second volume that is greater than the first volume when the flow controller 140 is placed in the second state. As described in more detail herein, the increase in volume of the isolation chamber 130 may provide a suction force operable to draw an initial volume of bodily fluid into the isolation chamber 130. Further, in some embodiments, flow controller 140 can have a size, shape, and / or configuration that enables isolation chamber 130 to receive a volume of air or gas (e.g., a volume of air disposed in a flow path between a source of bodily fluid and the isolated portion) and an initial amount or volume of bodily fluid. In such embodiments, flow controller 140 can be configured to define any number of portions, volumes, channels, etc. that can receive and / or contain at least one of a volume of air or an initial volume of bodily fluid.

[0045]

[0061] In some embodiments, the size, shape, configuration, and / or materials of construction of the flow controller 140 can be configured and / or otherwise selected such that the flow controller 140 transitions from the first state to the second state in a predetermined manner and / or at a predetermined or desired rate. In some examples, controlling the rate at which the flow controller 140 transitions from the first state to the second state can further control and / or regulate the rate of bodily fluid flow into the isolation chamber 130 and / or the magnitude of the suction force generated within the isolation chamber 130 that is operable to draw an initial volume of bodily fluid into the isolation chamber 130. Although not shown in FIG. 1, in some embodiments, the housing 110 can include valves, membranes, porous materials, restrictions, orifices, and / or any other suitable members, devices, and / or features configured to regulate the suction force applied to a surface of the flow controller 140, thereby regulating the rate at which the flow controller 140 transitions from the first state to the second state.

[0046]

[0062] In some examples, by controlling the rate at which the flow controller 140 transitions and / or the magnitude of the pressure differential and / or suction force generated within the isolation chamber 130, the likelihood of hemolysis of the blood sample and / or collapsing a vein, for example, can be reduced (e.g., this is particularly important when obtaining a sample of bodily fluid from a frail patient). In some examples, by adjusting the transition of the flow controller 140 and / or the pressure differential generated within the isolation chamber 130, the amount or volume of bodily fluid transferred into the isolation chamber 130 can be at least partially controlled (i.e., the volume of the initial amount of bodily fluid can be controlled).

[0047]

[0063] The actuator 150 of the device 100 is at least partially disposed within the housing 110 and configured to control, direct, and / or otherwise facilitate selective flow of fluid through at least a portion of the housing 110. The actuator 150 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the actuator 150 may be any suitable member or device configured to transition between a first state and a second state. In some embodiments, for example, the actuator 150 may be a valve, a plunger, a seal, a membrane, a bladder, a flap, a plate, a rod, a switch, or the like. In some embodiments, the actuator 150 may include one or more seals configured to selectively establish fluid communication between the fluid flow channel 113 and the fluid flow channel 116 when the actuator 150 transitions from the first state to the second state.

[0048]

[0064] The actuator 150 may be actuated and / or transitioned between the first and second states in any suitable manner. For example, in some embodiments, transitioning the actuator 150 may include activating, pressing, moving, translating, rotating, switching, sliding, opening, closing, and / or otherwise reconfiguring the actuator 150. In some examples, the actuator 150 may transition between the first and second states in response to manual actuation by a user (e.g., applying a manual force to a button, slider, plunger, switch, valve, rotating member, conduit, etc.). In other embodiments, the actuator 150 may be configured to automatically transition between the first and second states in response to a pressure differential (or lack of pressure), a change in position or kinetic energy, a change in composition or configuration (e.g., a portion of the actuator may at least partially dissolve or transform), etc. In still other embodiments, the actuator 150 may be mechanically (e.g., via a motor, etc.) and / or electrically actuated or transitioned based on a volume of bodily fluid received over a period of time, a volumetric flow rate of the bodily fluid flow, a flow rate of the bodily fluid flow, etc. While examples of actuators and / or ways in which the actuators may transition are provided, it should be understood that they are presented by way of example only and not limitation.

[0049]

[0065] In some embodiments, the actuator 150 can be configured to separate, isolate, disconnect, and / or otherwise block fluid communication between at least a portion of the flow path 115 and at least a portion of the flow path 116 when in a first state, and can be configured to place the flow path 115 (or at least a portion thereof) in fluid communication with the flow path 116 (or at least a portion thereof) when in a second state. Additionally, the actuator 150 can be configured to separate, isolate, disconnect, and / or otherwise block fluid communication between the isolation chamber 130 and at least a portion of the inlet 113, the outlet 114, and / or the flow paths 115 and 116. Thus, when the actuator 150 is in its second position, the isolation chamber 130 can be isolated and / or fluidly isolated from other flow paths or portions of the housing 110, and the inlet 113 can be placed in fluid communication with the outlet 114. Thus, as described in further detail herein, the actuator 150 can cause a subsequent volume of bodily fluid (e.g., a volume of bodily fluid after the initial volume of bodily fluid) to be transferred to a fluid collection device 180 fluidly coupled to the outlet 114.

[0050]

[0066] As described above, device 100 can be used to obtain a sample of bodily fluid with reduced contamination from microorganisms, such as, for example, skin-resident microorganisms. For example, in some examples, a user, such as a doctor, physician, nurse, phlebotomist, technician, etc., can operate device 100 to establish fluid communication between inlet 113 and a source of bodily fluid (e.g., a patient's vein, cerebrospinal fluid (CSF) from the spinal cavity, a urine collection, etc.). As a given example, in some examples, inlet 113 can be coupled to and / or include a needle or the like that can be operated to pierce the patient's skin and insert at least a portion of the needle into the patient's vein, thereby placing inlet 113 in fluid communication with the source of bodily fluid (e.g., a vein, an IV catheter, a PICC, etc.).

[0051]

[0067] In some embodiments, when the inlet 113 is placed in fluid communication with a source of bodily fluid (e.g., a portion of a patient), the outlet 114 can be fluidly coupled to the fluid collection device 180. As described above, in some embodiments, the fluid collection device 180 can be any suitable reservoir, container, and / or device configured to receive bodily fluid of a bodily fluid. For example, the fluid collection device 180 can be a vacuum reservoir or container that defines a negative pressure and / or can be a syringe that can be operated to generate a negative pressure. In some examples, coupling the outlet 114 to the fluid collection device 180 selectively exposes at least a portion of the flow path 116 to a negative pressure and / or suction force within the fluid collection device 180. As described above, a portion and / or surface of the flow controller 140 can be in fluid communication with the flow path 116, and thus a negative pressure and / or suction force can be applied to a portion and / or surface of the flow controller 140. The negative pressure and / or suction may then be operable to transition the flow controller 140 from its first state, in which the isolation chamber 130 has a first volume, to its second state, in which the isolation chamber 130 has a second volume that is greater than the first volume. Thus, in response to the transition of the flow controller 140 (e.g., an increase in the volume of the isolation chamber 130 as a result of the flow controller 140 transitioning from the first state to the second state), an initial volume of bodily fluid may be drawn into the isolation chamber 130.

[0052]

[0068] In some embodiments, for example, the flow controller 140 may be a bladder or the like configured to transition or "flip" in response to negative pressure. The flow controller 140 may be configured to transition in a predetermined manner and / or at a predetermined rate, thereby controlling, regulating, and / or otherwise determining one or more characteristics associated with the flow of the initial volume of bodily fluid into the isolation chamber 130. In some embodiments, the flow controller 140 and, for example, one or more inner surfaces of the housing 110 may collectively define multiple distinct portions of the isolation chamber 130. In such an embodiment, at least one of the portions of the isolation chamber 130 may be configured to accommodate a volume of air that is drawn into the isolation chamber 130 immediately prior to the initial volume of bodily fluid, as described in detail above. Thus, transitioning the flow controller 140 from the first state to the second state may cause an initial portion of the volume of bodily fluid (also referred to herein as the "initial volume" or "first volume") to flow from the inlet 113 through at least a portion of the flow path 115 into the isolation chamber 130. In some embodiments, transitioning the flow controller 140 from a first state to a second state can transition the control device 100 from a first or initial state or configuration to a second state or configuration in which an initial portion or volume of bodily fluid can flow into or through at least a portion of the flow path 115 and into the isolation chamber 130.

[0053]

[0069] The initial volume of bodily fluid may be any suitable volume of bodily fluid, as discussed above. For example, in some instances, the control device 100 may remain in the second state or configuration until a predetermined and / or desired volume (e.g., the initial volume) of bodily fluid is transferred to the isolation chamber 130. In some embodiments, the initial volume may be related to and / or based at least in part on a volume of the isolation chamber 130 or a portion thereof (e.g., a volume sufficient to fill the isolation chamber 130 or a desired portion of the isolation chamber 130). In other embodiments, the initial volume of bodily fluid may be related to and / or based at least in part on an amount or volume of bodily fluid that is the same as or greater than a volume associated with a flow path defined between a bodily fluid source and the isolation chamber 130. In still other embodiments, the control device 100 may be configured to transfer a flow of bodily fluid (e.g., the initial volume) into the isolation chamber 130 until a pressure differential between the isolation chamber 130 and the flow path 115 and / or the volume source is substantially balanced and / or otherwise drops below a desired threshold.

[0054]

[0070] After the initial volume of bodily fluid is transferred and / or diverted into the isolation chamber 130, the control device 100 may transition from the second state or configuration to a third state or configuration. For example, in some embodiments, when the initial volume of bodily fluid is transferred into the isolation chamber 130, the actuator 150 may transition from its first state to its second state, thereby causing the control device 100 to be in its third state. More specifically, in some embodiments, the arrangement of the control device 100 and / or the isolation chamber 130 may be such that the flow of bodily fluid into the isolation chamber 130 substantially stops or slows in response to receiving the initial volume. In some embodiments, for example, the isolation chamber 130 may receive a flow of bodily fluid (e.g., an initial volume of bodily fluid) until a pressure differential is equalized within the isolation chamber 130 and / or between the isolation chamber 130 and the flow path 115 and / or the volume source. In some examples, a user may visually inspect device 100 and / or a portion of housing 110 to determine that an initial volume of bodily fluid has been disposed in isolation chamber 130 and / or that the flow of bodily fluid into isolation chamber 130 has slowed or substantially stopped. In some embodiments, a user may apply a force to actuator 150 and / or otherwise actuate actuator 150 to transition actuator 150 from its first state to its second state. In other embodiments, actuator 150 may transition automatically (e.g., without user intervention).

[0055]

[0071] Transitioning the actuator 150 from its first state to its second state (e.g., placing the control device 100 in its third state or configuration) may isolate, separate, sequester, and / or retain the initial volume of bodily fluid within the isolation chamber 130. As described in more detail herein, in some instances, contaminants may be introduced and / or contained within the initial volume of bodily fluid, such as, for example, skin-resident microorganisms shed during a venipuncture event, other external sources of contamination, colonization of catheters and PICC lines used to collect the sample, etc. Thus, such contaminants are isolated within the isolation chamber 130 when the initial volume is isolated therein.

[0056]

[0072] In addition to isolating an initial volume of bodily fluid within the isolation chamber 130, placing the actuator 150 in its second state may also establish fluid communication between at least a portion of the flow path 115 and at least a portion of the flow path 116 to allow a subsequent volume of bodily fluid to flow from the inlet 113 through at least a portion of the flow paths 115 and / or 116 to the outlet 114. For example, in some embodiments, transitioning the actuator 150 from its first state to its second state may, for example, open or close a port or valve, move one or more seals, move or remove one or more obstructions, define one or more portions of a flow path, etc. With the fluid collection device 180 fluidly coupled to the outlet 114 and the control device 100 in the third state or configuration, a negative pressure differential and / or suction force that is otherwise applied to the flow controller 140 may be applied to or through at least a portion of the flow paths 115 and 116. Thus, any subsequent volume of bodily fluid may flow from inlet 113, through at least a portion of flow paths 115 and 116, through outlet 114, and into fluid collection device 180. As discussed above, by isolating an initial volume of bodily fluid in isolation chamber 130 prior to collecting or obtaining one or more sample volumes of bodily fluid (e.g., in fluid collection device 180), the amount of contaminants in the one or more sample volumes is reduced and / or substantially eliminated. Further, in some embodiments, the arrangement of control device 100 may be such that control device 100 is unable to transition to the third state before collecting and isolating an initial volume in isolation chamber 130.

[0057]

[0073] 2-11 illustrate a fluid control device 200 according to another embodiment. The fluid control device 200 (also referred to herein as a "control device" or "device") may be similar in form and / or function to the device 100 described above with reference to FIG. 1. For example, as described above with respect to the device 100, the device 200 may be configured, in response to being placed in fluid connection with a negative pressure source (e.g., a suction or vacuum source), to (1) draw bodily fluid from a source into the device 200, (2) divert and isolate a first portion or amount (e.g., an initial volume) of the bodily fluid in a portion of the device 200, and (3) cause a second portion or amount (e.g., a subsequent volume) of the bodily fluid to flow through the device 200 (bypassing the isolated initial volume) and into a fluid collection device fluidly coupled to the device 200. Thus, contaminants and the like may be isolated in or with the initial volume of bodily fluid, leaving the subsequent volume of bodily fluid substantially free of contaminants.

[0058]

[0074] Fluid control device 200 (also referred to herein as a "control device" or "device") includes a housing 210, a flow controller 240, and an actuator 250. In some embodiments, control device 200, or at least a portion of control device 200, may be arranged in a modular configuration, where one or more portions of housing 210 and / or actuator 250 may be physically and fluidly coupled (e.g., by an end user) to collectively form control device 200. Similarly, in some embodiments, control device 200 may be packaged, shipped, and / or stored separately from fluid collection devices (e.g., sample reservoirs, syringes, etc.) and / or inlet devices (e.g., needles, catheters, peripheral intravenous lines (PIVs), peripherally inserted central catheters (PICCs), etc.) that may be coupled to control device 200 by a user prior to or during use. In other embodiments, control device 200 need not be modular. For example, in some embodiments, control device 200 may be assembled during manufacturing and delivered to a supplier and / or end user as a pre-assembled device. In some embodiments, the control device 200 can include and / or be pre-coupled (e.g., during manufacture and / or prior to delivery to an end user) to a fluid collection device, such as any of those described above. Similarly, in some embodiments, the control device 200 can include and / or be pre-coupled to an inlet device, such as any of those described herein.

[0059]

[0075] The housing 210 of the control device 200 may be of any suitable shape, size, and / or configuration. The housing 210 includes an actuator portion 212 and an isolation portion 220. The actuator portion 212 of the housing 210 receives at least a portion of the actuator 250. The isolation portion 220 of the housing 210 is coupled to a cover 235 and includes, receives, contains, and / or at least partially defines an isolation chamber 230. As described in more detail herein, the housing 210 may include and / or define a first port 217 and a second port 218, each of which establishes fluid communication between the actuator portion 212 and the isolation portion 220 of the housing 210 to selectively control and / or enable the flow of fluid through one or more portions of the housing 210.

[0060]

[0076] As shown in FIGS. 2-6, the actuator portion 212 of the housing 210 includes an inlet 213 and an outlet 214. The inlet 213 is configured to be placed in fluid communication with a bodily fluid source to receive a flow of bodily fluid therefrom, as described in detail above. For example, the inlet 213 can be directly or indirectly coupled to a lumen-containing device, such as a needle, IV catheter, PICC line, etc., which is further in fluid communication with a bodily fluid source (e.g., inserted into a patient's body). The outlet 214 is configured to be fluidly coupled to a fluid collection device, such as any of those described above. For example, the fluid collection device can be a sample reservoir, a syringe, an intermediate bodily fluid transfer device, an adapter or container (e.g., a transfer adapter similar to those described in the '783 patent), etc. Additionally, the fluid collection device can be operated to define and / or define a vacuum within the fluid collection device, such that coupling the fluid collection device to the outlet 214 creates a negative pressure differential between one or more portions of the housing 210, as described in more detail herein.

[0061]

[0077] 7-11, for example, the actuator portion 212 defines a flow path 215 in fluid communication with the inlet 213 and a flow path 216 in fluid communication with the outlet 214. More specifically, the flow path 215 (e.g., a first flow path) is configured to selectively place the inlet 213 in fluid communication with a first port 217, and the flow path 216 (e.g., a second flow path) is configured to selectively place the outlet 214 in fluid communication with a second port 218. Additionally, as described in more detail herein, after an initial volume of bodily fluid is transferred into the isolation chamber 230, fluid communication can be established between the flow paths 215 and 216 such that a subsequent volume of bodily fluid can flow from the inlet 213 through at least a portion of the flow paths 215 and 216 to the outlet 214 (and / or to a fluid collection device coupled to the outlet 214).

[0062]

[0078] The isolation portion 220 of the housing 210 may be of any suitable shape, size, and / or configuration. For example, as shown in FIGS. 6-8, the isolation portion 220 includes and / or forms an inner surface, a portion of which is arranged and / or configured to form a first contoured surface 221. As described in more detail herein, at least a portion of the first contoured surface 221 can form and / or define a portion of the isolation chamber 230. Additionally, the first port 217 and the second port 218 are configured to form and / or extend through a portion of the first contoured surface 221 to selectively place the isolation chamber 230 in fluid communication with the flow channels 215 and 216, as described in more detail herein.

[0063]

[0079] The isolation portion 220 is configured to include, form, and / or house an outer shell member 225 and a flow controller 240. More specifically, as shown in FIGS. 6-8 , the isolation portion 220 receives and / or is coupled to the outer shell member 225 such that the flow controller 240 is disposed between the isolation portion 220 and the outer shell member 225. In some embodiments, the outer shell member 225 can be fixedly coupled to the isolation portion 220 via adhesives, ultrasonic welding, and / or any other suitable bonding method. In some embodiments, the outer shell member 225, the isolation portion 220, and the flow controller 240 can collectively form a substantially fluid-tight and / or hermetic seal that separates the isolation portion 220 from a volume outside the isolation portion 220.

[0064]

[0080] As shown, the cover 235 is disposed about the shell member 225 such that the cover 235 and the isolation portion 220 of the housing 210 are configured to enclose and / or house the shell member 225 and the flow controller 240. In some embodiments, the cover 235 can be coupled to the shell member 225 and / or the isolation portion 220 via adhesives, ultrasonic welding, one or more mechanical fasteners, friction fit, snap fit, threaded coupling, and / or any other suitable manner of coupling. In some embodiments, the cover 235 can define an opening, window, slot, etc. configured to allow visualization of at least a portion of the isolation chamber 230. Although the shell member 225 and the cover 235 are described above as being separate parts and / or components, in other embodiments, the shell member 225 can be integral and / or formed integrally with the cover 235.

[0065]

[0081] The outer shell 225 includes and / or forms a second uneven surface 226. The arrangement of the outer shell 225 and the isolation portion 220 of the housing 210 can be such that at least a portion of the first uneven surface 221 is aligned and / or faces a corresponding portion of the second uneven surface 226 of the outer shell 225 (see, for example, FIG. 8 ). Thus, a space, volume, opening, void, chamber, etc. defined between the first uneven surface 221 and the second uneven surface 226 forms and / or defines the isolation chamber 230. Additionally, as described in more detail herein, the flow controller 240 is disposed between the first uneven surface 221 and the second uneven surface 226 and can be configured to transition between a first state and a second state in response to application of a negative pressure differential and / or suction force to at least a portion of the isolation chamber 230.

[0066]

[0082] The ports 217 and 218 of the housing 210 may be of any suitable shape, size, and / or configuration. As discussed above, the first port 217 is in fluid communication with the isolation chamber 230 and may selectively establish fluid communication between the isolation chamber 230 and the flow path 215 and / or the inlet 213. More specifically, the first port 217 is in fluid communication with a first portion of the isolation chamber 230 defined between the second contoured surface 226 and a first side of the flow controller 240. As described in more detail herein, the first port 217 may be configured to provide and / or transfer a flow of bodily fluid from the inlet 213 and the flow path 215 into the first portion of the isolation chamber 230 defined between the second contoured surface 226 and a first side of the flow controller 240 in response to the flow controller 240 transitioning from a first state to a second state.

[0067]

[0083] The second port 218 is in fluid communication with the isolation chamber 230 and can selectively establish fluid communication between the isolation chamber 230 and the flow path 216 and / or the outlet 214. More specifically, the second port 218 is in fluid communication with a second portion of the isolation chamber 230 defined between the first uneven surface 221 and a second side (e.g., opposite the first side) of the flow controller 240. As described in more detail herein, the second port 218 can be configured to expose the second portion of the isolation chamber 230 defined between the first uneven surface 221 and the second side of the flow controller 240 to a negative pressure differential and / or suction force resulting from a fluid collection device (e.g., evacuated blood collection tube, culture bottle, syringe, etc.) being fluidly coupled to the outlet 214. Furthermore, the negative pressure differential and / or suction force can be operable to transition the flow controller 240 from its first state to its second state. In some examples, it may be desirable to adjust and / or control the magnitude of the negative pressure differential. Accordingly, the second port 218 can include and / or be coupled to a restriction 219. As described in further detail herein, the restriction 219 can be configured to restrict and / or limit the flow of fluid (e.g., air or gas) between the second portion of the isolation chamber 230 and the flow path 216, thereby adjusting and / or controlling the magnitude of the pressure differential and / or suction force applied to or experienced by the flow controller 240.

[0068]

[0084] The flow controller 240 is disposed within the housing 210 between the isolation portion 220 and the shell member 225 (e.g., within the isolation chamber 230). The flow controller 240 may be of any suitable shape, size, and / or configuration. Similarly, the flow controller 240 may be formed of any suitable material (e.g., any suitable biocompatible material such as those described herein, and / or any other suitable material). For example, the flow controller 240 may be a fluid impermeable bladder, membrane, diaphragm, etc. configured to transition from a first state and / or configuration to a second state and / or configuration. In some embodiments, the flow controller 240 (e.g., a bladder) may include any number of relatively thin and flexible portions configured to deform in response to a pressure differential across the flow controller 240. For example, in some embodiments, the flow controller 240 may be formed of or from any suitable medical grade elastomer and / or any of the biocompatible materials described above. In some embodiments, the flow controller 240 can have a durometer hardness of about 5 Shore A to about 70 Shore A, about 10 Shore A to about 60 Shore A, about 20 Shore A to about 50 Shore A, about 30 Shore A to about 40 Shore A, and / or any other suitable durometer hardness. In some embodiments, the flow controller 240 can be formed of or from a silicone having a durometer hardness of about 20 Shore A to about 50 Shore A. More particularly, in some such embodiments, the flow controller 240 can be formed of or from a silicone having a durometer hardness of about 30 Shore A. In some embodiments, the flow controller 240 can include a relatively thin and flexible portion having a thickness of about 0.001 inches to about 0.1 inches. In other embodiments, the relatively thin and flexible portion can have a thickness that is less than 0.001 inches or greater than 0.1 inches.

[0069]

[0085] In some embodiments, the flow controller 240 can have a size and / or shape configured to facilitate, promote, and / or otherwise provide a fluid flow having a desired set of flow characteristics. Similarly, the flow controller 240 can be formed of or from a material having one or more material properties and / or one or more surface finishes configured to facilitate, promote, and / or otherwise provide a fluid flow having a desired set of flow characteristics. As described in more detail herein, the set of flow characteristics can be and / or can include a relatively uniform or smooth fluid flow, a substantially laminar fluid flow and / or a relatively low turbulence fluid flow, a fluid flow having a substantially uniform front surface, a fluid flow that does not readily mix with other fluids (e.g., a flow of air or a flow of a bodily fluid that does not mix with a volume of air), and the like.

[0070]

[0086] In the embodiment shown in FIGS. 2-11, the flow controller 240 is a bladder (or diaphragm) formed of or from a silicone having a durometer hardness of about 30 Shore A. The flow controller 240 (e.g., a bladder) includes a first deformable portion 241, a second deformable portion 242, and a third deformable portion 243. Additionally, the flow controller 240 defines an opening 244. For example, as shown in FIG. 8, the flow controller 240 can be positioned within the isolated portion 220 of the housing 210 such that the first port 217 extends through the opening 244. In some embodiments, the arrangement of the flow controller 240 is such that a surface of the flow controller 240 that defines the opening 244 forms a substantially fluid-tight seal with a portion of an inner surface of the isolated portion 220 of the housing 210 (e.g., the portion that defines and / or forms the first port 217). Additionally, as described in more detail herein, the flow controller 240 may include one or more portions configured to form one or more seals with the flow controller 240 and each of the uneven surfaces 221 and 226, and / or between the flow controller 240 and each of the uneven surfaces 221 and 226.

[0071]

[0087] The deformable portions 241, 242, and 243 of the flow controller 240 may be relatively thin and flexible portions configured to deform in response to a pressure differential between a first side of the flow controller 240 and a second side of the flow controller 240. More specifically, the deformable portions 241, 242, and 243 may each have a thickness of about 0.005 inches. As shown, for example, in FIGS. 8 and 10, the deformable portions 241, 242, and 243 of the flow controller 240 correspond to and / or have substantially the same general shape as at least a portion of the uneven surfaces 221 and / or 226. Thus, as described in more detail herein, the deformable portions 241, 242, and 243 and the corresponding portions of the uneven surfaces 221 and / or 226 may collectively form and / or define one or more channels, or the like, which may further receive an initial volume of bodily fluid.

[0072]

[0088] As discussed above, the flow controller 240 is configured to transition between a first state and a second state. For example, as shown in FIG. 8, when the flow controller 240 is in its first state, the deformable portions 241, 242, and 243 are disposed adjacent to and / or substantially in contact with the second uneven surface 226. More specifically, the first deformable portion 241 can be disposed adjacent to and / or substantially in contact with a first recess 227 formed by the second uneven surface 226, the second deformable portion 242 can be disposed adjacent to and / or substantially in contact with a second recess 228 formed by the second uneven surface 226, and the third deformable portion 243 can be disposed adjacent to and / or substantially in contact with a third recess 229 formed by the second uneven surface 226.

[0073]

[0089] Thus, a first portion of the isolation chamber 230 (e.g., a portion defined between the second uneven surface 226 and a first surface of the flow controller 240) can have a relatively small and / or relatively negligible volume. In contrast, when the flow controller 240 transitions from its first state to its second state (e.g., in response to negative pressure applied and / or transmitted via the second port 218), at least the deformable portions 241, 242, and 243 are disposed adjacent to and / or in substantial contact with the first uneven surface 221. More specifically, the first deformable portion 241 can be disposed adjacent to and / or in substantial contact with a first recess 222 formed by the first uneven surface 221, the second deformable portion 242 can be disposed adjacent to and / or in substantial contact with a second recess 223 formed by the first uneven surface 221, and the third deformable portion 243 can be disposed adjacent to and / or in substantial contact with, for example, a non-concave portion of the first uneven surface 221.

[0074]

[0090] Thus, the volume of the first portion of the isolation chamber 230 is greater when the flow controller is in its second state than when it is in its first state. In other words, the deformable portions 241, 242, and 243 and the second contoured surface 226 can define one or more channels (e.g., the isolation chamber 230) configured to receive an initial volume of bodily fluid. In some examples, the increase in volume of the first portion of the isolation chamber 230 can create a negative pressure or vacuum therein that can be operable to draw the initial volume of bodily fluid into the isolation chamber 230, as described in further detail herein. Furthermore, in some embodiments, the arrangement of the deformable portions 241, 242, and / or 243 can be such that a volume of air drawn into the isolation chamber 230 immediately prior to the flow of bodily fluid can flow into and / or be disposed in the portion of the isolation chamber 230 corresponding to the first deformable portion 241 and / or the second deformable portion 242.

[0075]

[0091] Although flow controller 240 is described in detail above with reference to FIGS. 6-11, in other embodiments, flow controller 240 and / or isolation chamber 230 can have any suitable configuration and / or arrangement. For example, in some embodiments, textured surfaces 221 and / or 226 can include more or fewer recesses (e.g., recesses 222 and 223 and recesses 227, 228 and 229, respectively). In other embodiments, the depth of one or more recesses can be modified. Similarly, flow controller 240 can be modified in any suitable manner to substantially correspond to the shape and / or configuration of textured surfaces 221 and / or 226. In some embodiments, such modifications can change, for example, one or more characteristics associated with the flow of gases (e.g., air) and / or fluids (e.g., bodily fluids), one or more characteristics associated with the manner and speed at which flow controller 240 transitions, etc., as described in more detail herein.

[0076]

[0092] Although flow controller 240 has been described as being a bladder including multiple deformable portions or the like, in other embodiments, the flow controller may be arranged and / or configured as, for example, a bellows, a flexible pouch, an inflatable bag, an inflatable chamber, a plunger (e.g., similar to a syringe), and / or any other suitable reconfigurable container, etc. Additionally, isolation chamber 230 formed at least in part by flow controller 240 may have any suitable shape, size and / or configuration.

[0077]

[0093] The actuator 250 of the control device 200 may be of any suitable shape, size, and / or configuration. At least a portion of the actuator 250 is disposed within the actuator portion 212 of the housing 210 and configured to transition between a first state, configuration, and / or position and a second state, configuration, and / or position. In the embodiment shown in FIGS. 2-11, the actuator 250 is configured as an actuator rod or plunger configured to move relative to the actuator portion 212 of the housing 210. The actuator 250 includes an end 251 disposed outside the housing 210 and configured to be actuated by a user to transition the actuator 250 between its first state and its second state. As shown in FIGS. 6-11, a portion of the actuator 250 includes and / or is coupled to a set of seals 255. The seals 255 may be, for example, an O-ring, an elastomeric overmold, a raised or bulging portion or fitting, or the like. The arrangement of the actuator 250 and the actuator portion 212 of the housing 210 can be such that an inner portion of the seal 255 forms a fluid-tight seal with a surface of the actuator 250 and an outer portion of the seal 255 forms a fluid-tight seal with an inner surface of the actuator portion 212 of the body 210. In other words, the seal 255 forms one or more fluid-tight seals between the actuator 250 and the inner surface of the actuator portion 212. As shown in FIGS. 7-11, the actuator 250 can include and / or be coupled to four seals 255, which can be distributed along the actuator 250 to selectively form and / or define one or more flow paths between the actuator 250 and the four seals 255. Additionally, as described in more detail herein, the actuator 250 defines a flow channel 252 defined between a pair of the seals 255 that can aid and / or facilitate fluid communication between the flow paths 215 and 216 when the actuator 250 transitions to its second state.Although the actuator 250 is described above as including four seals 255 , in other embodiments, the actuator 250 can include fewer than four seals 255 or more than four seals 255 .

[0078]

[0094] In some embodiments, the actuator portion 212 of the housing 210 and the actuator 250 collectively include and / or collectively form a lock. For example, as shown in FIGS. 6 and 8 , the actuator portion 212 of the housing 210 can define an opening 238 and the actuator 250 can include a locking member, latch, protrusion, tab, or the like (referred to herein as “lock 253”) configured to be at least partially disposed within the opening 238. In some embodiments, the lock 253 can be aligned and / or disposed within the opening 238 and can limit and / or substantially prevent the actuator 250 from being removed from the housing 210. In some embodiments, the lock 253 can be transitioned between a locked state, in which the lock 253 limits and / or substantially prevents the actuator 250 from moving relative to the housing 210, and an unlocked state, in which the lock 253 can move the actuator 250, for example, between its first state and / or position and its second state and / or position. In some examples, such an arrangement can limit and / or substantially prevent actuation of actuator 250, for example, before an initial volume of bodily fluid has been transferred within isolation chamber 230. In other embodiments, lock 253 can transition from an unlocked state to a locked state, for example, after an initial volume of bodily fluid has been transferred within isolation chamber 230.

[0079]

[0095] 7 and 8, when the actuator 250 is disposed in a first state and / or position (e.g., prior to using the device 100), the flow path 215 can establish fluid communication between the inlet 213 and the first port 217. More specifically, the actuator 250 can be in a position relative to the housing 210 such that each of the seals 255 is disposed on an opposite side of the inlet 213 relative to a side of the inlet 213 associated with the first port 217. In other words, the actuator 250 and / or the seal 255 do not impede and / or block the flow path 215 when the actuator 250 is in the first state and / or position, as shown in FIGS. 7 and 8. Thus, as described in more detail herein, when the actuator 250 is in the first state and / or position, a volume (e.g., an initial volume) of bodily fluid can flow from the inlet 213, through the flow path 215 and the first port 217, and into the isolation chamber 230.

[0080]

[0096] As shown in FIGS. 9-11, a force can be applied to the end 251 of the actuator 250 to place the actuator 250 in its second state and / or position. When in the second state and / or position, the inlet 213 and the outlet 214 are placed in fluid communication via at least a portion of the flow paths 215 and 216 and / or the flow channel 252. As shown in FIGS. 9 and 11, the actuator 250 can be positioned such that the inlet 213 and the outlet 214 are each disposed between the same pair of seals 255, thereby allowing the flow of bodily fluid therethrough. Additionally, the flow channel 252 defined by the actuator 250 assists and / or facilitates the flow of bodily fluid (see, e.g., FIG. 11). For example, in some embodiments, the flow channel 252 can establish fluid communication between a portion of the flow path 215 defined by the inlet 213 and a portion of the flow path 216 defined by the outlet 214. Additionally, the arrangement of seal 255 is such that first port 217 and second port 218 are each isolated and / or separated from each of inlet 213 and outlet 214. Thus, placing actuator 250 in a second state and / or position can (1) isolate and / or separate isolation chamber 230 and any volume of bodily fluid disposed therein, and (2) establish fluid communication between inlet 213 and outlet 214, thereby allowing a volume of bodily fluid to flow through device 200 and into a fluid collection device (not shown) fluidically coupled to outlet 214.

[0081]

[0097] In some embodiments, the set of seals 255 can be configured to isolate, separate and / or seal one or more portions of the device 200 prior to establishing fluid communication between other portions of the device 200. For example, in some embodiments, as described above, the actuator 250 can be in a first position relative to the actuator portion 212 of the housing 210 when in the first state. In such an example, actuating actuator 250 (e.g., applying a force to end 251 of actuator 250) can include moving actuator 250 from a first position relative to actuator portion 212 to a second position relative to actuator portion 212, where (1) first seal 255 is positioned between first port 217 and inlet 213 and / or its lumen, (2) inlet 213 and / or its lumen is positioned between first seal 255 and second seal 255, (3) outlet 214 and / or its lumen is positioned between second seal 255 and third seal 255, and (4) second port 218 is positioned between third seal 255 and fourth seal 255. In this manner, the inlet 213 is isolated from the first port 217, the outlet 214 is isolated from the second port 218, and no fluid communication has yet been established between the inlet 213 and the outlet 214 (e.g., the inlet 213 is isolated from the outlet 214).

[0082]

[0098] In some examples, actuation of actuator 250 can further include moving actuator 250 from a second position relative to actuator portion 212 to a third position relative to actuator portion 212 in which actuator 250 is in the second state. Thus, second seal 255 is disposed between first port 217 and inlet 213 and / or its lumen, each of inlet 213 and outlet 214 (and / or their lumen) is disposed between second seal 255 and third seal 255, and second port 218 is disposed between third seal 255 and fourth seal 255. Thus, each of first port 217 and second port 218 is isolated from inlet 213 and outlet 214 (and / or their lumen), and fluid communication is established (e.g., via flow channel 252) between inlet 213 and outlet (and / or their lumen).

[0083]

[0099] Although the actuator 250 is described in this example as moving between a first position, a second position, and a third position relative to the actuator portion 212, it should be understood that transitioning the actuator 250 from the first state to the second state can include moving the actuator 250 from the first position relative to the actuator portion 212, through the second position relative to the actuator portion 212, to the third position relative to the actuator portion 212 in a substantially continuous manner. In other embodiments, the actuator 250 can be actuated, moved, and / or transitioned in any number of discrete steps. For example, in some examples, the actuator 250 can be transitioned a first predetermined amount to move the actuator 250 from the first position relative to the actuator portion 212 to the second position relative to the actuator portion 212, and then transitioned a second predetermined amount (e.g., in a second and / or discrete step) to move the actuator 250 from the second position relative to the actuator portion 212 to the third position relative to the actuator portion 212. Although actuator 250 is described above as including four seals 255, in other embodiments, the actuator may be functionally similar to actuator 250 and may include fewer than four seals (e.g., one seal, two seals, or three seals) or more than four seals (e.g., five seals, six seals, seven seals, or more seals).

[0084]

[0100] As described above, device 200 can be used to obtain a sample of bodily fluid with reduced contamination (e.g., contamination from microorganisms, e.g., skin-resident microorganisms, microorganisms external to the source of bodily fluid, etc.). For example, prior to use, device 200 can be in its first, initial and / or storage state or mode of operation, with flow controller 240 and actuator 250 each in their respective first or initial state. With device 200 in the first state, a user, such as a doctor, physician, nurse, phlebotomist, technician, etc., can manipulate device 200 to establish fluid communication between inlet 213 and a source of bodily fluid (e.g., a patient's vein). Once inlet 213 is placed in fluid connection with the source of bodily fluid, outlet 214 can be fluidly coupled to a fluid collection device (not shown in FIGS. 2-11 ). In the embodiments shown in Figures 2-11, for example, the fluid collection device may be an evacuated blood collection tube, a culture bottle, a sample reservoir, a syringe, and / or any other suitable container or device configured to define or generate negative pressure, suction force, vacuum, and / or energy potential.

[0085]

[0101] When the actuator 250 is in a first position and / or configuration, the inlet 213 of the housing 210 is in fluid communication with, for example, a flow passage 215, which is further in fluid communication with a first port 217. The outlet 214 of the housing 210 is in fluid communication with a flow passage 216, which is further in fluid communication with a second port 218. More specifically, as shown in Figures 7 and 8, one or more of the seals 255 of the actuator 250 may be in a position relative to the actuator portion 212 of the housing 210 that (1) enables and / or establishes fluid communication between the inlet 213, the flow passage 215, and the first port 217, and (2) fluidly isolates the inlet 213, the flow passage 215, and the first port 217 from the outlet 214, the flow passage 216, and the second port 218. Thus, when the control device 200 is in a first state or operating mode (e.g., when the actuator 250 and the flow controller 240 are each in their first state), fluidly coupling the fluid collection device to the outlet 214 creates and / or otherwise provides a negative pressure differential and / or suction force within at least a portion of the flow path 216, and further within a portion of the isolation chamber 230 defined between a surface (e.g., a first surface) of the flow controller 240 and the first contoured surface 221 of the housing 210.

[0086]

[0102] The flow controller 240 is in a first state and / or configuration prior to coupling a fluid collection device to the outlet 214. In the embodiment illustrated in FIGS. 2-11, the flow controller 240 is a fluid impermeable bladder, diaphragm, membrane, etc., which may have an inverted, inverted, collapsed, and / or empty configuration (e.g., first state and / or configuration) prior to coupling a fluid collection device to the outlet 214. For example, as illustrated in FIG. 8, when the flow controller 240 is in its first state and / or configuration, the flow controller 240 may be positioned adjacent to and / or in contact with the second contoured surface 226. Stated differently, a first side (opposite the second side) of the flow controller 240 may be positioned adjacent to and / or in contact with the second contoured surface 226.

[0087]

[0103] As discussed above, the flow controller 240 is configured to transition from its first state and / or configuration to its second state and / or configuration in response to the creation of a negative pressure differential and / or suction force within a portion of the isolation chamber 230 defined between the flow controller 240 and the first contoured surface 221. For example, as shown in FIG. 10, the flow controller 240 can be configured to transition, move, "flip," and / or reconfigure its second state and / or configuration in which the flow controller 240 and / or a second side of the flow controller 240 (opposite the first side) is disposed adjacent to and / or in contact with the first contoured surface 221. Stated differently, the negative pressure differential and / or suction force attracts, pulls, and / or otherwise moves at least a portion of the flow controller 240 toward the first contoured surface 221 and away from the second contoured surface 226. Furthermore, when the actuator 250 is in its first state and the flow controller 240 is in its second state, the control device 200 is placed in its second state and / or configuration.

[0088]

[0104] The transition of the flow controller 240 results in an increase in the interior volume of the portion of the isolation chamber 230 defined between a surface of the flow controller 240 (e.g., a first side of the flow controller 240) and the second contoured surface 226. The increase in interior volume can then create a negative pressure differential between the portion of the isolation chamber 230 (defined at least in part by the flow controller 240) and, for example, the inlet 213 that is operable to draw at least a portion of an initial flow, amount, or volume of bodily fluid from the inlet 213 through the flow path 215 and the first port 217 and into the portion of the isolation chamber 230. In some examples, the initial volume and / or flow of bodily fluid can be transferred into the isolation chamber 230 until, for example, the flow controller 240 is fully expanded, reversed, and / or transitioned, until the negative pressure differential is reduced and / or equalized, and / or until a desired volume of bodily fluid is disposed within the portion of the isolation chamber 230.

[0089]

[0105] In some examples, it may be desirable to adjust and / or control the manner in which the flow controller 240 transitions and / or the magnitude of the negative pressure differential and / or suction force that develops within the isolation chamber 230 on one or both sides of the flow controller 240. In the embodiment shown in Figures 2-11, for example, the second port 218 defines, includes, receives, and / or is otherwise coupled to a restriction 219 that establishes fluid communication between the flow path 216 and a portion of the isolation chamber 230 defined between the flow controller 240 and the first contoured surface 221.

[0090]

[0106] In some embodiments, the restriction 219 can define a lumen or flow path having a relatively small diameter (e.g., relative to the diameter of at least a portion of the flow path 216). For example, in some embodiments, the restriction 219 can have a diameter of about 0.0005 inches, about 0.001 inches, about 0.003 inches, about 0.005 inches, about 0.01 inches, about 0.1 inches, about 0.5 inches, or more. In other embodiments, the restriction 219 can have a diameter less than 0.0005 inches or more than 0.5 inches. In some embodiments, the restriction 219 can have a predetermined and / or desired length of about 0.01 inches, about 0.05 inches, about 0.1 inches, about 0.15 inches, about 0.2 inches, about 0.5 inches, or more. In other embodiments, the restriction 219 can have a predetermined and / or desired length that is less than 0.01 inches or more than about 0.5 inches. Further, in some embodiments, the restriction 219 can have any suitable combination of diameter and length that allows and / or provides desired fluid (e.g., air) flow characteristics through at least a portion of the control device 200. Although the restriction 219 is described above as defining a relatively small lumen and / or flow path, in other embodiments, the restriction can have any suitable shape, size and / or configuration. For example, in some embodiments, the restriction can be a porous material, a semi-permeable member or membrane, a mechanical valve, a float and / or limiter, and / or any other suitable member or device configured to regulate a pressure differential across at least a portion thereof.

[0091]

[0107] 2-11, the relatively small diameter of the restriction 219 results in a lower magnitude of negative pressure being applied through and / or within the portion of the isolation chamber 230 than would otherwise be applied by a restriction having a larger diameter, or than would be applied if the second port 218 did not include or receive the restriction 219. For example, in some embodiments, the fluid collection device and / or other suitable negative pressure source can define and / or generate a negative pressure differential having a magnitude (e.g., a negative magnitude) of about 0.5 pounds per square inch (PSI), about 1.0 PSI, about 2.0 PSI, about 3.0 PSI, about 4.0 PSI, about 5.0 PSI, about 10.0 PSI, about 12.5 PSI, or about 14.7 PSI (at or substantially at sea level pressure). In some embodiments, a fluid collection device, such as an evacuated blood collection tube, can have a predetermined negative pressure of about 12.0 PSI. Thus, by controlling the diameter and / or length of the restriction 219, the amount of negative pressure to which the portion of the isolation chamber 230 is exposed and / or the rate at which the negative pressure is applied can be controlled, reduced, and / or otherwise adjusted. In some examples, the use of the restriction 219 can cause the negative pressure applied on or in the portion of the isolation chamber 230 to be delayed or increased.

[0092]

[0108] It should be understood that while pressure regulation is described above as being based on the diameter of the restriction 219 (i.e., a single restricted flow path), this is presented merely as an example and not as a limitation. Other means for regulating the amount of negative pressure to which the portion of the isolation chamber 230 is exposed can include, for example, porous materials, valves, membranes, diaphragms, predetermined restrictions, vents, deformable members or flow paths, and / or any other suitable means. In other embodiments, the control device can include any suitable number of restricted flow paths, each of which can have substantially the same diameter or can have different diameters. For example, in some embodiments, the control device can include up to 100 or more restricted flow paths. In such embodiments, each of the restricted flow paths can have a diameter of about 0.0005 inches to about 0.1 inches, about 0.0005 inches to about 0.05 inches, or about 0.0005 inches to about 0.01 inches. In some embodiments, the multiple restricted flow paths can be configured to selectively provide a flow path between the outlet 214 and the portion of the isolation chamber 230 that exposes the portion of the isolation chamber 230 to a negative pressure differential.

[0093]

[0109] In some embodiments, the rate at which one or more volumes of the isolation chamber 230 increase can be adjusted by adjusting and / or controlling the amount of pressure to which the portions of the isolation chamber 230 are exposed. In some examples, the rate of volume increase (and therefore the suction force) can be adjusted to adjust and / or limit the amount of pressure applied to the bodily fluid and / or within the patient's veins. In some examples, such pressure adjustment can reduce the likelihood of hemolysis of a blood sample and / or collapsing a vein, for example. In some examples, being able to adjust and / or control the amount or magnitude of negative pressure or suction allows the control device 200 to be used across a wide range of patients who may have physiological challenges where negative pressure is necessary to facilitate collection of bodily fluids, such as blood (i.e., the pressure difference between atmospheric pressure and the patient's vascular pressure is not sufficient to facilitate a consistent and sufficiently forceful flow), but not so high that rapid forces would reduce, collapse, dent, and / or otherwise impede the patency and ability to collect blood.

[0094]

[0110] In some embodiments, the shape, size, and / or configuration of the isolation chamber 230 and / or the flow controller 240, the magnitude of the negative pressure differential or suction force, and / or the manner in which the negative pressure differential or suction force is applied can dictate and / or control the rate and / or manner in which the flow controller 240 transitions from a first state to a second state. In some examples, controlling the rate, sequence, and / or manner in which the flow controller 240 transitions can result in one or more desired flow characteristics associated with the flow of air, gas, and / or bodily fluids into and / or through at least a portion of the isolation chamber 230.

[0095]

[0111] For example, an arrangement included in this embodiment may be one in which the third deformable portion 243 of the flow controller 240 completes its transition and / or inversion before the first deformable portion 241 and the second deformable portion 242 complete their transition and / or inversion. In some examples, this arrangement may be one in which the portion of the isolation chamber 230 collectively defined by the first deformable portion 241 and the first recess 227 of the second contoured surface 226 (e.g., a first volume of the isolation chamber 230) receives at least a portion of a volume of air that was in the flow path between the source of bodily fluid and the isolation chamber 230 before the flow path received and / or filled with bodily fluid. Similarly, the portion of the isolation chamber 230 collectively defined by the second deformable portion 242 and the second recess 228 of the second contoured surface 226 (e.g., a second volume of the isolation chamber 230) may receive at least a portion of the volume of air that was in the flow path. In other words, a transition of the flow controller 240 may evacuate, exhaust, and / or purge air or gas from the flow path between the bodily fluid source and the isolation chamber 230, where such air or gas may then be collected, stored, and / or contained within the first and second volumes of the isolation chamber 230. Meanwhile, a portion of the isolation chamber 230 collectively defined by the third deformable portion 243 and the third recess 229 of the second contoured surface 226 (e.g., the third volume of the isolation chamber 230) may receive an initial volume of bodily fluid flowing through the flow path between the bodily fluid source and the isolation chamber 230 after the air or gas has been collected within the first and / or second volumes of the isolation chamber 230.

[0096]

[0112] In some examples, the arrangement and / or sequence of transitions of the deformable portions 241, 242 and / or 243 can provide, for example, a uniform flow of an initial volume of bodily fluid into the third volume of the isolation chamber 230. More specifically, the third deformable portion 243 is configured to complete or substantially complete a transition and / or reversal from its first state and / or position prior to a completed or substantially completed transition and / or reversal of the first deformable portion 241 and / or the second deformable portion 242, respectively, such that bodily fluid can flow into and / or through at least a portion of the third deformable portion 243 with a substantially uniform front surface. In this manner, the third deformable portion 243 can be in a second state, configuration and / or position prior to the flow of bodily fluid entering the isolation chamber 230. Thus, the third volume of the isolation chamber 230 can have and / or can define a relatively consistent and / or uniform cross-sectional shape and / or area as the flow of bodily fluid enters the isolation chamber 230, thereby limiting the siphoning of portions of the bodily fluid flow, inconsistent local flow rates of the bodily fluid flow, and / or otherwise uneven filling of the third volume of the isolation chamber 230.

[0097]

[0113] 8 and 10, the first uneven surface 221 includes recesses 222 and 223, each of which is deeper than a portion of the first uneven surface 221 that is aligned with and / or otherwise associated with the deformable portion 243 of the flow controller 240. In other words, the distance between the first recess 222 and the second recess 223 of the first uneven surface 221 and the first recess 227 and the second recess 228 of the second uneven surface 226, respectively, is greater than the distance between said portions of the first uneven surface 221 and the third recess 229 of the second uneven surface 226. Thus, the distance traveled by the first deformable portion 241 and the second deformable portion 242 when they transition and / or reverse is greater than the distance traveled by the third deformable portion 243 when they transition and / or reverse. Furthermore, the width of the first deformable portion 241 and the second deformable portion 242 can be similar to or smaller than the width of the third deformable portion 243. In some examples, such an arrangement allows the third deformable portion 243 to complete or substantially complete its transition and / or reversal before each of the first and second deformable portions 241 and 242 complete or substantially complete their transition and / or reversal, respectively. In other embodiments, the distance and / or width of movement of one or more of the deformable portions 241, 242 and / or 243 can be altered (increased or decreased) to modify and / or change the speed, sequence and / or sequence associated with the deformable portions 241, 242 and / or 243 transitioning and / or reversing from the first state to the second state.

[0098]

[0114] In some embodiments, including fewer or more deformable portions can, for example, change the relative stiffness of or associated with each deformable portion and / or otherwise control the rate and / or manner in which each of the deformable portions transition or reverse, thereby changing the rate and / or manner in which fluid (e.g., air and / or volume) flows into isolation chamber 230. For example, in some embodiments, increasing the number of deformable portions can reduce the surface area over which negative pressure is applied, thereby increasing the pressure differential sufficient to cause the deformable portions to transition and / or reverse. Although in FIGS. 8 and 10 deformable portions 241, 242, and 243 are shown as having substantially the same thickness, in other embodiments, at least one deformable portion can have a thickness that is different from the thickness of the other deformable portions (e.g., deformable portion 241 can have a thickness that is different from the thickness of deformable portion 242 and / or deformable portion 243 (or vice versa, or in other combinations)). In some examples, increasing the thickness of a deformable portion relative to the thickness of other deformable portions can increase the stiffness of that deformable portion relative to the stiffness of the other deformable portions. In some such examples, increasing the stiffness of a thicker deformable portion can cause other deformable portions (e.g., thinner deformable portions) to transition and / or invert before the thicker / stiffer deformable portion transitions and / or inverts. In some embodiments, a deformable portion can have a different thickness along at least a portion of the deformable portion.

[0099]

[0115] In some embodiments, the size, shape, material properties, surface finish, etc. of the flow controller 240 and / or the deformable portions 241, 242, and / or 243 can also facilitate, promote, and / or otherwise provide a fluid flow having a substantially uniform front surface. For example, the third volume of the isolation chamber 230 (collectively defined by the third deformable portion 243 and the third recess 229 of the second uneven surface 226) can have a size, shape, diameter, perimeter, and / or cross-sectional area that can limit and / or substantially prevent air from mixing with the bodily fluid flow (e.g., the flow front) due, at least in part, to surface tension between the bodily fluid flow and each of the third deformable portion 243 and the third recess 229 of the second uneven surface 226. In some embodiments, for example, the third volume of the isolation chamber 230 can have a size, shape, diameter, perimeter, and / or cross-sectional area that can limit and / or substantially prevent air from mixing with the bodily fluid flow (e.g., the flow front) due to surface tension between the bodily fluid flow and each of the third deformable portion 243 and the third recess 229 of the second uneven surface 226. 2 ) ~ approx. 0.16in 2 , about 0.001in 2 ~ approx. 0.08in 2 , Approx. 0.006in 2 ~ approx. 0.06in 2 , or about 0.025 in. 2 ~ approx. 0.04in 2 In another embodiment, the third volume of the isolation chamber 230 can have a cross-sectional area of ​​0.0001 in. 2 Less than or equal to 0.16in 2 The cross-sectional area may be greater than or equal to 100 mm.

[0100]

[0116] In some embodiments, the flow controller 240 and / or the textured member 225 (or at least the second textured surface 226 thereof) can be formed of or from a material having one or more material properties and / or one or more surface finishes configured to facilitate, promote, and / or otherwise provide fluid flow having a desired set of flow characteristics. In other embodiments, the flow controller 240 and / or the second textured surface 226 can have a coating configured to provide a desired set of flow characteristics. For example, in some embodiments, the flow controller 240 and / or the second textured surface 226 can be formed of and / or otherwise include a coating of a hydrophobic or hydrophilic material. Furthermore, at least a portion of the flow controller 240 and the textured member 225 (or at least the second textured surface 226 thereof) can be formed of or from the same material and / or can include the same coating, or can be formed of or from different materials and / or can include different coatings. Similarly, the flow controller 240 and / or the second textured surface 226 can include any suitable surface finish, which may be substantially the same or different. In some examples, a non-exclusive list of the desired set of flow characteristics can be and / or include one or more of a relatively uniform or smooth fluid flow, a substantially laminar fluid flow and / or a relatively low turbulence fluid flow, a fluid flow having a substantially uniform front surface, a fluid flow that does not readily mix with other fluids (e.g., a flow of air or a flow of a bodily fluid that does not mix with a volume of air), a relatively uniform velocity flow, and / or the like.

[0101]

[0117] Although several aspects and / or features of the embodiments illustrated in FIGS. 2-11 have been described above along with methods for modifying and / or "tuning" such aspects and / or features, it should be understood that the flow controller and / or isolation chamber (or any structure forming the isolation chamber) can have any suitable arrangement that results in a desired rate, manner and / or sequence of conveying an initial volume of bodily fluid into one or more portions or volumes of the isolation chamber 230. In some embodiments, the flow controller and / or isolation chamber can include and / or incorporate any suitable combination of the above-described aspects and / or features. Any number of the above-described aspects and / or features can be included in the device, and such aspects and / or features can act together or in concert to provide a desired fluid flow and / or desired fluid flow characteristics through at least a portion of the isolation chamber. Furthermore, it should be understood that the above-described aspects and / or features are provided merely by way of example and not by way of limitation.

[0102]

[0118] Upon transfer of the initial volume of bodily fluid to the isolation chamber 230, a force may be applied to the end 251 of the actuator 250 to transition and / or place the actuator 250 into its second position, state, operating mode and / or configuration, as described above. In some examples, the actuator 250 may be transitioned from a locked to an unlocked configuration or state prior to application of a force to the end 251 of the actuator 250. In the embodiments shown in FIGS. 2-11, the transition of the actuator 250 may be accomplished by interaction and / or manipulation of the actuator 250 by a user and / or may be otherwise effected from such. However, in other embodiments, the transition of the actuator 250 may occur automatically in response to negative pressure and / or associated flow dynamics within the device 200, and / or may be effected by or in response to an external energy source that generates one or more dynamics or conditions that result in the transition of the actuator 250.

[0103]

[0119] 9-11, when the flow controller 240 and the actuator 250 are each in their second state, the control device 200 is placed in its third state. When the actuator 250 transitions from its second state, position and / or configuration, the inlet 213 and the outlet 214 are placed in a fluidly connected state (e.g., via the flow paths 215 and 216 and / or a portion of the flow channel 252), while the first port 217 and the second port 218 are isolated, separated and / or otherwise not in fluid communication with the inlet 213 and / or the outlet 214. Thus, the initial volume of bodily fluid is isolated within a portion of the isolation chamber 230 (e.g., the third volume of the isolation chamber 230, as described above). Furthermore, in some examples, contaminants, such as, for example, skin-resident microorganisms and / or any other contaminants, may be entrained and / or contained within the initial volume of bodily fluid and thus be isolated within the isolation chamber 230 when the initial volume is isolated within the isolation chamber 230. Thus, negative pressure that was previously applied on or through flow path 216 and through second port 218 is now applied to or through outlet 214 and inlet 213, e.g., via flow paths 215 and 216 and / or at least a portion of flow channel 252 of actuator 250 (FIG. 11). In response, bodily fluid can flow from inlet 213, through actuator portion 212 of housing 210, through outlet 214, and into a fluid collection device coupled to outlet 214. Device 200 can thus function in a substantially similar manner to device 100, described in detail above with reference to FIG.

[0104]

[0120] 12-21 illustrate a fluid control device 300 according to another embodiment. The fluid control device 300 (also referred to herein as a "control device" or "device") may be similar in form and / or function to the devices 100 and / or 200 described above. For example, as described above with respect to devices 100 and 200, the device 300 may be configured, in response to being placed in fluid connection with a negative pressure source (e.g., a suction or vacuum source), to (1) draw bodily fluid from a source into the device 300, (2) divert and isolate a first portion or amount (e.g., an initial volume) of the bodily fluid in a portion of the device 300, and (3) cause a second portion or amount (e.g., a subsequent volume) of the bodily fluid to flow through the device 300 (bypassing the isolated initial volume) and into a fluid collection device fluidly coupled to the device 300. Thus, contaminants and the like may be isolated in or with the initial volume of bodily fluid, leaving the subsequent volume of bodily fluid substantially free of contaminants. In some embodiments, parts and / or aspects of control device 300 may be similar and / or substantially identical to parts and / or aspects of control device 200 described above with reference to Figures 2-11. Accordingly, such similar parts and / or aspects may not be described in further detail herein.

[0105]

[0121] The fluid control device 300 (also referred to herein as a "control device" or "device") includes a housing 310, a flow controller 340, and an actuator 350. In some embodiments, the control device 300, or at least a portion of the control device, may be arranged in a modular configuration, where one or more portions of the housing 310 and / or the actuator 350 may be physically and fluidly coupled (e.g., by an end user) to collectively form the control device 300. Similarly, in some embodiments, the control device 300 may be packaged, shipped, and / or stored separately from fluid collection devices (e.g., sample reservoirs, syringes, etc.) and / or inlet devices (e.g., needles, catheters, PIV, PICC, etc.) that may be coupled to the control device 300 by a user prior to or during use. In other embodiments, the control device 300 need not be modular. For example, in some embodiments, the control device 300 may be assembled during manufacturing and delivered to a supplier and / or end user as a pre-assembled device. In some embodiments, the control device 300 can include a fluid collection device, such as any of those described above, and / or can be pre-coupled to such a fluid control device (e.g., during manufacture and / or prior to delivery to an end user). Similarly, in some embodiments, the control device 300 can include an inlet device, such as any of those described herein, and / or can be pre-coupled to such an inlet device.

[0106]

[0122] The housing 310 of the control device 300 may be of any suitable shape, size, and / or configuration. The housing 310 includes an actuator portion 312 and an isolation portion 320. The actuator portion 312 receives at least a portion of the actuator 350. The isolation portion 320 is coupled to a cover 335 and includes, receives, contains, and / or at least partially defines an isolation chamber 330. As described in more detail herein, the housing 310 may include and / or define a first port 317 and a second port 318, each of which establishes fluid communication between the actuator portion 312 and the isolation portion 320 of the housing 310 to selectively control and / or enable the flow of fluid through one or more portions of the housing 310.

[0107]

[0123] As shown in Figures 12-16, the actuator portion 312 of the housing 310 includes an inlet 313 and an outlet 314, defining a flow path 315 (e.g., a first flow path) configured to selectively place the inlet 313 in fluid communication with a first port 317, and a flow path 316 (e.g., a second flow path) configured to selectively place the outlet 314 in fluid communication with a second port 318. The inlet 313 of the housing 310 is configured to be placed in fluid communication with a source of bodily fluid (e.g., in fluid communication with a patient via a needle, IV catheter, PICC line, etc.) to receive a flow of bodily fluid therefrom, as described in detail above. The outlet 314 is configured to be fluidly coupled to a fluid collection device, such as any of those described above (e.g., a sample reservoir, a syringe, a culture bottle, an intermediate bodily fluid transfer device or adapter, etc.). The fluid collection device can define and / or be operated to define a vacuum or negative pressure that results in a negative pressure differential between desired portions of the housing 310 when the fluid collection device is coupled to the outlet 314. Additionally, after an initial volume of bodily fluid is transferred into the isolation chamber 330, fluid communication can be established between the flow paths 315 and 316 to allow a subsequent volume of the fluid (e.g., a sample of the bodily fluid) to flow through the device 300 and into the fluid collection device. Thus, the actuator portion 312 of the housing 310 can be substantially similar in at least form and / or function to the actuator portion 212 of the housing 210, and therefore will not be described in further detail herein.

[0108]

[0124] The isolation portion 320 of the housing 310 may be of any suitable shape, size, and / or configuration. For example, as shown in FIGS. 16-18, the isolation portion 320 includes and / or forms an inner surface, a portion of which is arranged and / or configured to form a first contoured surface 321. As described in more detail herein, at least a portion of the first contoured surface 321 can form and / or define a portion of the isolation chamber 330. Additionally, the first port 317 and the second port 318 are configured to form and / or extend through a portion of the first contoured surface 321 to selectively place the isolation chamber 330 in fluid communication with the flow channels 315 and 316, as described in more detail herein.

[0109]

[0125] The isolation portion 320 is configured to include, form, and / or house an outer shell member 325 and a flow controller 340. More specifically, as shown in FIGS. 16-18 , the isolation portion 320 receives and / or is coupled to the outer shell member 325 such that the flow controller 340 is disposed between the isolation portion 320 and the outer shell member 325. In some embodiments, the outer shell member 325 can be fixedly coupled to the isolation portion 320 via adhesives, ultrasonic welding, and / or any other suitable bonding method. In some embodiments, the outer shell member 325, the isolation portion 320, and the flow controller 340 can collectively form a substantially fluid-tight and / or hermetic seal that separates the isolation portion 320 from a volume outside the isolation portion 320.

[0110]

[0126] As shown, the cover 335 is disposed about the shell member 325 such that the cover 335 and the isolation portion 320 of the housing 310 are configured to enclose and / or house the shell member 325 and the flow controller 340. In some embodiments, the cover 335 can be coupled to the shell member 325 and / or the isolation portion 320 via adhesives, ultrasonic welding, one or more mechanical fasteners, friction fit, snap fit, threaded coupling, and / or any other suitable coupling method. In some embodiments, the cover 335 can define an opening, window, slot, etc. configured to allow visualization of at least a portion of the isolation chamber 330. Although the shell member 325 and the cover 335 are described above as separate parts and / or components, in other embodiments, the shell member 325 can be integrated and / or integrally formed with the cover 335.

[0111]

[0127] The outer shell member 325 includes and / or forms a second uneven surface 326. The arrangement of the outer shell member 325 and the isolation portion 320 of the housing 310 can be such that at least a portion of the first uneven surface 321 is aligned and / or faces a corresponding portion of the second uneven surface 326 of the outer shell member 325 (see, for example, FIG. 18 ). Thus, a space, volume, opening, void, chamber, etc. defined between the first uneven surface 321 and the second uneven surface 326 forms and / or defines the isolation chamber 330. Additionally, as described in more detail herein, the flow controller 340 is disposed between the first uneven surface 321 and the second uneven surface 326 and can be configured to transition between a first state and a second state in response to application of a negative pressure differential and / or suction to at least a portion of the isolation chamber 330.

[0112]

[0128] The ports 317 and 318 of the housing 310 may be of any suitable shape, size, and / or configuration. As described in detail above with respect to the first port 217, the first port 317 is in fluid communication with a first portion of the isolation chamber 330 defined between the second contoured surface 326 and a first side of the flow controller 340, and is configured to provide and / or transfer a flow of bodily fluid from the inlet 313 and / or the flow path 315 to the first portion of the isolation chamber 330 in response to the flow controller 340 transitioning from the first state to the second state. As described above with respect to the second port 218, the second port 318 is in fluid communication with a second portion of the isolation chamber 330 defined between the first contoured surface 321 and a second side of the flow controller 340 (e.g., opposite the first side). Thus, as described in detail above with respect to device 200, second port 318 can be configured to expose the second portion of isolation chamber 330 to a negative pressure differential and / or suction force provided by the fluid collection device operable to transition flow controller 340 from its first state to its second state. Additionally, second port 318 can include and / or be coupled to a restriction 319 configured to restrict and / or limit the flow of fluid (e.g., air or gas) between the second portion of isolation chamber 330 and flow path 316, as described in detail above with respect to restriction 219 of device 200, thereby regulating and / or controlling the magnitude of the pressure differential and / or suction force applied to or experienced by flow controller 340.

[0113]

[0129] The flow controller 340 disposed within the isolated portion 320 of the housing 310 may be of any suitable shape, size, and / or configuration. Similarly, the flow controller 340 may be formed of any suitable material (e.g., any suitable biocompatible material, such as those described herein, and / or any other suitable material). For example, the flow controller 340 may be a fluid-impermeable bladder configured to transition from a first state and / or configuration to a second state and / or configuration. In some embodiments, the flow controller 340 (e.g., a bladder) may include any number of relatively thin and flexible portions configured to deform in response to a pressure differential across the flow controller 340. In some embodiments, the flow controller 340 may be substantially similar in form and / or function at least to the flow controller 240 described in detail above with reference to FIGS. 2-11. For example, in some embodiments, the flow controller 340 may be formed of or from any suitable material and / or have any suitable durometer hardness, such as the materials and / or durometer hardnesses described above with respect to the flow controller 240. Similarly, the flow controller 340 may have a size, shape, surface finish, and / or material properties configured to facilitate, promote, and / or otherwise provide fluid flow having a desired set of flow characteristics, as described above with respect to the flow controller 240. As such, portions of the flow controller 340 may not be described in further detail herein.

[0114]

[0130] In the embodiment shown in FIGS. 12-21, the flow controller 340 is a bladder formed of or from a silicone having a durometer hardness of about 30 Shore A. The flow controller 340 (e.g., a bladder) includes a first deformable portion 341 and a second deformable portion 342. Additionally, the flow controller 340 defines an opening 344 configured to receive at least a portion of the first port 317, as described above with respect to the flow controller 240. In some embodiments, the flow controller 340 can include one or more portions configured to form one or more seals with the flow controller 340 and each of the textured surfaces 321 and 326, and / or between the flow controller 340 and each of the textured surfaces 321 and 326, as described in more detail herein.

[0115]

[0131] The deformable portions 341 and 342 of the flow controller 340 may be relatively thin and flexible portions configured to deform in response to a pressure differential between a first side of the flow controller 340 and a second side of the flow controller 340. More specifically, the deformable portions 341 and 342 may each have a thickness of about 0.005 inches. As shown, for example, in FIGS. 18 and 20 , the deformable portions 341 and 342 of the flow controller 340 correspond to and / or have substantially the same general shape as at least a portion of the uneven surfaces 321 and / or 326. Thus, as described in more detail herein, the deformable portions 341 and 342 and the corresponding portions of the uneven surfaces 321 and / or 326 may collectively form and / or define one or more channels, volumes, etc., which may further receive an initial volume of bodily fluid.

[0116]

[0132] As described above with respect to the flow controller 240, the flow controller 340 is configured to transition between a first state and a second state. For example, when the flow controller 340 is in its first state, the first deformable portion 341 can be disposed adjacent to and / or in substantial contact with a first recess 327 formed by the second uneven surface 326, and the second deformable portion 342 can be disposed adjacent to and / or in substantial contact with a second recess 328 formed by the second uneven surface 326. Thus, a first portion of the isolation chamber 330 (e.g., a portion defined between the second uneven surface 326 and the first surface of the flow controller 340) can have a relatively small and / or relatively negligible volume. In contrast, when the flow controller 340 transitions from its first state to its second state (e.g., in response to negative pressure applied and / or transmitted via the second port 318), the first deformable portion 341 can be disposed adjacent to and / or in substantial contact with the first recess 322 formed by the first uneven surface 321, and the second deformable portion 342 can be disposed adjacent to and / or in substantial contact with the second recess 323 formed by the first uneven surface 321. Thus, the volume of the first portion of the isolation chamber 330 is greater when the flow controller 340 is in its second state than when the flow controller 340 is in its first state. As described in detail above with respect to the isolation chamber 230 and the flow controller 240, the increase in volume of the first portion of the isolation chamber 330 can create a negative pressure or vacuum therein that can be operable to draw an initial volume of bodily fluid into the isolation chamber 330 along with a volume of air or gas.

[0117]

[0133] Although flow controller 340 has been specifically shown and described, in other embodiments, flow controller 340 and / or isolation chamber 330 can have any suitable configuration and / or arrangement. For example, in some embodiments, textured surfaces 321 and / or 326 can include more or fewer recesses (e.g., recesses 322 and 323 and recesses 327 and 328). In other embodiments, the depth of one or more recesses can be modified. Similarly, flow controller 340 can be modified in any suitable manner to substantially correspond to the shape and / or configuration of textured surfaces 321 and / or 326. Although flow controller 340 has been described as being a bladder or the like including multiple deformable portions, in other embodiments, flow controller can be arranged and / or configured as, for example, a bellows, a flexible pouch, an expandable bag, an expandable chamber, a plunger (e.g., similar to a syringe), and / or any other suitable reconfigurable container, and the like. Furthermore, the isolation chamber 330, which is defined at least in part by the flow controller 340, can have any suitable shape, size and / or configuration.

[0118]

[0134] The actuator 350 of the control device 300 may be of any suitable shape, size, and / or configuration. At least a portion of the actuator 350 is disposed within the actuator portion 312 of the housing 310 and is configured to transition between a first state, configuration, and / or position and a second state, configuration, and / or position. In the embodiment illustrated in Figures 12-21, the actuator 350 is configured as an actuator rod or plunger configured to move relative to the actuator portion 312 of the housing 310. The actuator 350 further includes a set of seals 355 and defines a flow channel 352. Actuator 350 includes an end 351 disposed outside housing 310, end 351 configured to be actuated by a user to transition actuator 350 between its first state in which flow path 315 can establish fluid communication between inlet 313 and first port 317, and its second state in which (1) first port 317 (and thus isolation chamber 330) is isolated and / or fluidly separated, and (2) inlet 313 and outlet 314 are placed in fluid communication via at least a portion of flow paths 315 and 316 and / or flow channel 352 of actuator 350. Actuator 350 is therefore similar in form and / or function to actuator 250 described above with reference to Figures 2-11. Actuator 350 will therefore not be described in further detail herein.

[0119]

[0135] Device 300 can be used to obtain a sample of bodily fluid with reduced contamination (e.g., from microorganisms, e.g., skin-resident microorganisms, microorganisms external to the bodily fluid source, etc.) in a manner substantially similar to that described above with respect to device 200. For example, prior to use, device 300 can be in its first, initial and / or storage state or mode of operation, with flow controller 340 and actuator 350 each in their respective first or initial state. With device 300 in the first state, a user, such as a doctor, physician, nurse, phlebotomist, technician, etc., can manipulate device 300 to establish fluid communication between inlet 313 and a bodily fluid source (e.g., a patient's vein). Once inlet 313 is placed in fluid connection with the bodily fluid source, outlet 314 can be fluidly coupled to a fluid collection device (not shown in FIGS. 12-21 ). In the embodiments shown in Figures 12-21, for example, the fluid collection device may be an evacuated blood collection tube, a culture bottle, a sample reservoir, a syringe, and / or any other suitable container or device configured to define or generate negative pressure, suction force, vacuum, and / or energy potential.

[0120]

[0136] When the actuator 350 is in a first position and / or configuration, the inlet 313 of the housing 310 is in fluid communication, for example, with the flow passage 315, which is further in fluid communication with a first port 317 (see, e.g., FIGS. 17 and 18). The outlet 314 of the housing 310 is in fluid communication with the flow passage 316, which is further in fluid communication with a second port 318 (see, e.g., FIGS. 17 and 18). As described in detail above, when the control device 300 is in a first state or mode of operation (e.g., when the actuator 350 and the flow controller 340 are each in their first state), fluidly coupling the fluid collection device to the outlet 314 creates and / or otherwise creates a negative pressure differential and / or suction force within at least a portion of the flow passage 316 and also within a portion of the isolation chamber 330 defined between a surface (e.g., a first surface) of the flow controller 340 and the first contoured surface 321 of the housing 310.

[0121]

[0137] The flow controller 340 is in a first state and / or configuration prior to a fluid collection device being coupled to the outlet 314. In the embodiment illustrated in Figures 12-21, the flow controller 340 is a fluid impermeable bladder or the like that can have an inverted, inverted, collapsed, and / or empty configuration (e.g., the first state and / or configuration) prior to coupling a fluid collection device to the outlet 314. For example, as illustrated in Figure 18, when the flow controller 340 is in its first state and / or configuration, the flow controller 340 can be positioned adjacent to and / or in contact with the second contoured surface 326.

[0122]

[0138] As discussed above, the flow controller 340 is configured to transition from its first state and / or configuration to its second state and / or configuration in response to the creation of a negative pressure differential and / or suction force within a portion of the isolation chamber 330 defined between the flow controller 340 and the first contoured surface 321. For example, the flow controller 340 can be disposed adjacent to and / or in contact with the second contoured surface 326 when the flow controller 340 is in its first state (FIG. 18) and can be transitioned, moved, "flipped," placed, and / or otherwise reconfigured to its second state (FIG. 20) in which the flow controller 340 is disposed adjacent to and / or in contact with the first contoured surface 321. Additionally, when the actuator 350 is in its first state and the flow controller 340 is in its second state, the control device 300 is placed in its second state and / or configuration.

[0123]

[0139] The transition of the flow controller 340 results in an increase in the internal volume of the portion of the isolation chamber 330 defined between a surface of the flow controller 340 (e.g., a second surface opposite the first surface) and the second contoured surface 326. As described in detail above with respect to the device 200, the increase in internal volume can create a negative pressure differential between the portion of the isolation chamber 330 (defined at least in part by the flow controller 340) and, for example, the inlet 313 that is operable to draw at least a portion of an initial flow, amount or volume of bodily fluid from the inlet 313 through the flow path 315 and the first port 317 into the portion of the isolation chamber 330. In some examples, the initial volume and / or flow of bodily fluid can be transferred into the isolation chamber 330 until, for example, the flow controller 340 is fully expanded, reversed and / or transitioned, until the negative pressure differential is reduced and / or equalized, and / or until a desired volume of bodily fluid is disposed within the portion of the isolation chamber 330. Additionally, as described above with respect to device 200, restriction 319 can be configured to limit, restrict, control, and / or adjust the magnitude of the negative pressure differential and / or suction force generated within isolation chamber 330 and / or against a surface of flow controller 340, thereby adjusting the suction force within one or more flow paths and / or within a bodily fluid source (e.g., a patient's vein). In other embodiments, second port 318 and / or any suitable portion of device 300 can be configured to adjust the suction force within one or more portions of isolation chamber 330 in any suitable manner, such as, for example, as described above with respect to device 200.

[0124]

[0140] In some embodiments, the shape, size, and / or configuration of the isolation chamber 330 and / or the flow controller 340, the magnitude of the negative pressure differential or suction force, and / or the manner in which the negative pressure differential or suction force is applied can direct and / or control the rate and / or manner in which the flow controller 340 transitions from the first state to the second state. For example, while the flow controller 240 is described above as including a first deformable portion 241, a second deformable portion 242, and a third deformable portion 243, the embodiment illustrated in Figures 12-21 includes a flow controller 340 that includes only the first deformable portion 341 and the second deformable portion 342. Additionally, as illustrated in Figures 18 and 20, the recesses 322 and 323 of the first contoured surface 321 have substantially the same depth. In some embodiments, such an arrangement can, for example, limit and / or reduce the amount of negative pressure and / or suction force sufficient to cause the first deformable portion 341 to transition and / or reverse relative to ...2 of the flow controller 340.

[0125]

[0141] As discussed above, in some embodiments, the first deformable portion 341 may have a thickness and / or stiffness greater than the thickness and / or stiffness of the second deformable portion 342 such that the second deformable portion 342 completes or substantially completes its transition and / or reversal before the first deformable portion 341 completes or substantially completes its transition and / or reversal. In other embodiments, the flow controller 340 may include any suitable features, structures, material properties, surface finishes, etc., and / or any other portion of the device 300 may include any suitable features, structures, etc., configured to control the order and / or manner in which the flow controller 340 transitions from the first state to the second state, such as any of those discussed above with respect to the flow controller 240. In some embodiments, the arrangement of the flow controller 340 may allow the device 300 to be compatible with fluid collection devices having a relatively low amount of negative pressure. In some embodiments, such an arrangement may also facilitate and / or simplify one or more manufacturing processes, etc. In some examples, the rate, sequence and / or manner can be controlled to provide one or more desired flow characteristics associated with the flow of air, gas and / or bodily fluids into and / or through at least a portion of the isolation chamber 230.

[0126]

[0142] As discussed above with respect to the deformable portions 241 and 242, the first deformable portion 341 and the first recess 327 of the second uneven surface 326 (e.g., the first volume of the isolation chamber 330) can be configured to receive a volume of air that was in the flow path between the bodily fluid source and the isolation chamber 330 before the flow path received and / or filled with bodily fluid. In other words, a transition of the flow controller 340 can evacuate or purge air or gas from the flow path between the bodily fluid source and the isolation chamber 330, and such air or gas can then be stored and / or contained within the first and second volumes of the isolation chamber 330. Meanwhile, the portion of the isolation chamber 330 collectively defined by the second deformable portion 342 and the second recess 328 of the second uneven surface 326 (e.g., the second volume of the isolation chamber 330) can be configured to receive an initial volume of bodily fluid that flows through the flow path between the bodily fluid source and the isolation chamber 330 after the air or gas has been evacuated and / or purged. Thus, the initial volume can be transferred into the isolation chamber 330 as described above with respect to device 200 .

[0127]

[0143] In some examples, the isolation chamber 330 and / or flow controller 340 arrangements can provide, for example, a uniform flow of the initial volume of bodily fluid into the second volume of the isolation chamber 330. For example, as described in detail above with respect to device 200, the isolation chamber 330 and / or flow controller 340 can be configured and / or arranged to cause the bodily fluid to flow into and / or through at least a portion of the isolation chamber 330 (e.g., the second volume of the isolation chamber 330) with a uniform flow front and without substantially mixing with the volume of air within the isolation chamber 330. In other embodiments, the flow controllers can have any other suitable arrangements to provide a desired rate, manner and / or sequence of conveying the initial volume of bodily fluid into one or more portions or volumes of the isolation chamber 330, such as, for example, any of those described above with respect to device 200.

[0128]

[0144] Upon transfer of the initial volume of bodily fluid into the isolation chamber 330, a force may be applied to the end 351 of the actuator 350 to transition and / or place the actuator 350 into its second position, state, operating mode and / or configuration, as described above. In some examples, the actuator 350 may be transitioned from a locked to an unlocked configuration or state prior to application of a force to the end 351 of the actuator 350. In the embodiments illustrated in FIGS. 12-21, the transition of the actuator 350 may be accomplished and / or may otherwise result from interaction and / or manipulation of the actuator 350 by a user. However, in other embodiments, the transition of the actuator 350 may occur automatically in response to negative pressure and / or associated flow dynamics within the device 300, and / or may be effected by or in response to an external energy source that generates one or more dynamics or conditions that result in the transition of the actuator 350.

[0129]

[0145] 19-21, when the flow controller 340 and the actuator 350 are each in their second state, the control device 300 is placed in its third state. When the actuator 350 transitions from its second state, position, and / or configuration, the inlet 313 and the outlet 314 are placed in a fluidly connected state (e.g., via the flow path 316 and / or the flow channel 352), while the flow path 315 and / or the first port 317 are isolated, separated, and / or otherwise not in fluid communication with the inlet 313 and / or the outlet 314. Thus, the initial volume of bodily fluid is sequestered within a portion of the isolation chamber 330 (e.g., the third volume of the isolation chamber 330, as described above). Furthermore, in some examples, contaminants, such as, for example, skin-resident microorganisms and / or any other contaminants, may be entrained and / or contained within the initial volume of bodily fluid and thus be sequestered within the isolation chamber 330 when the initial volume is isolated within the isolation chamber 330. Thus, negative pressure that would otherwise be applied on or through flow path 316 and through second port 318 is now applied to or through outlet 314 and inlet 313, e.g., via flow paths 315 and 316 and / or at least a portion of flow channel 352 of actuator 350 (FIG. 21). In response, bodily fluid can flow from inlet 313, through actuator portion 312 of housing 310, through outlet 314, and into a fluid collection device coupled to outlet 314. Device 300 can thus function in a substantially similar manner as devices 100 and / or 200, described in detail above.

[0130]

[0146] 22-27 show a fluid control device 400 according to another embodiment. The fluid control device 400 (also referred to herein as a "control device" or "device") may be similar in form and / or function to the devices 100, 200 and / or 300 described above. For example, as described above with respect to devices 100, 200 and / or 300, the device 400 may be configured, in response to being placed in fluid connection with a negative pressure source (e.g., a suction or vacuum source), to (1) draw bodily fluid from a source into the device 400, (2) divert and isolate a first portion or amount of bodily fluid (e.g., an initial volume) in a portion of the device 400, and (3) cause a second portion or amount of bodily fluid (e.g., a subsequent volume) to flow through the device 400 (bypassing the isolated initial volume) and into a fluid collection device fluidly coupled to the device 400. Thus, contaminants and the like may be sequestered in or with an initial volume of bodily fluid, leaving a subsequent volume of bodily fluid substantially free of contaminants. In some embodiments, parts and / or aspects of control device 400 may be similar and / or substantially identical to parts and / or aspects of control device 200 described above with reference to at least Figures 2-11. As such, such similar parts and / or aspects may not be described in further detail herein.

[0131]

[0147] Fluid control device 400 includes a housing 410, a flow controller 440, and an actuator 450. In some embodiments, as described above with respect to device 200, control device 400, or at least a portion of control device 400, may be arranged in a modular configuration (e.g., including one or more independent or separate components that are subsequently assembled), or may be arranged in an integrated or at least partially integrated configuration (e.g., including one or more components that are preassembled or precoupled). For example, in some embodiments, control device 400 may include and / or be coupled to a fluid collection device and / or an inlet device, such as any of those described above.

[0132]

[0148] The housing 410 of the control device 400 may be of any suitable shape, size, and / or configuration. Generally, the housing 410 may be substantially similar in form and / or function to the housing 210. Accordingly, although certain components, features, aspects and / or functions of the housing 410 are identified in the figures and described below, such similarities will not be described in further detail herein and such similarities should be considered similar to the corresponding components, features, aspects and / or functions described above with respect to the device 200, unless expressly stated to the contrary.

[0133]

[0149] The housing 410 includes an actuator portion 412 and an isolation portion 420. The actuator portion 412 receives at least a portion of the actuator 450. The isolation portion 420 is coupled to a cover 435 and includes, receives, contains, and / or at least partially defines an isolation chamber 430. As described in more detail herein, the housing 410 can include and / or define a first port 417 and a second port 418, each of which establishes fluid communication between the actuator portion 412 and the isolation portion 420 of the housing 410 to selectively control and / or enable fluid flow through one or more portions of the housing 410.

[0134]

[0150] Actuator portion 412 of housing 410 includes an inlet 413 and an outlet 414 and defines a flow path 415 (e.g., a first flow path) configured to selectively place in fluid communication with a first port 417, and a flow path 416 (e.g., a second flow path) configured to selectively place the outlet 414 in fluid communication with a second port 418. Actuator portion 412 of housing 410 may be substantially similar at least in form and / or function to actuator portion 212 of housing 210, and thus will not be described in further detail herein.

[0135]

[0151] The isolated portion 420 of the housing 410 may be of any suitable shape, size, and / or configuration. The isolated portion 420 is configured to include, form, and / or house the outer shell 425 and the flow controller 440. More specifically, a cover 435 is disposed about the outer shell 425 such that the cover 435 and the isolated portion 420 of the housing 410 are configured to enclose and / or house the outer shell 425 and the flow controller 440. The isolated portion 420 of the housing 410 and / or components of or coupled to the isolated portion 420 may be substantially similar in at least form and / or function to the isolated portion 220 of the housing 210 (and / or components of or coupled to the isolated portion 220) and therefore will not be described in further detail herein.

[0136]

[0152] 24-27, for example, isolation portion 420 includes and / or forms an inner surface, a portion of which is arranged and / or configured to form first contoured surface 421. As described in further detail herein, at least a portion of first contoured surface 421 can form and / or define a portion of isolation chamber 430. Additionally, as described above with respect to device 200, first port 417 and second port 418 are configured to form and / or extend through a portion of first contoured surface 421 to selectively place isolation chamber 430 in fluid communication with flow channels 415 and 416.

[0137]

[0153] The first contoured surface 421 may be of any suitable shape, curvature and / or texture, and may, for example, be substantially similar to the first contoured surface 221 of the housing 220. For example, the first contoured surface 421 includes and / or forms at least a first recess 422 and a second recess 423. However, the first contoured surface 421 may differ from the first contoured surface 221 by including any number of ventilation ridges 424, as shown in Figures 24-27. The distribution of the ventilation ridges 424 on the first contoured surface 421 may include a plurality of arrangements. 25 and 27, the first contoured surface 421 can have a ventilation ridge 424, multiple ventilation ridges 424, multiple concentric ventilation ridges 424, etc. disposed within and / or formed by the first recess 422, and / or a ventilation ridge 424, multiple ventilation ridges 424, multiple concentric ventilation ridges 424, etc. disposed within and / or formed by the second recess 423 of the first contoured surface 421. In some implementations, the ventilation ridges 424 are configured to reduce and / or control the ability or likelihood of the flow controller 440, or a portion thereof, to form a seal when placed in contact with the first contoured surface 421 in response to the application and / or transfer of negative pressure (e.g., negative pressure in a volume between the first contoured surface 421 and the flow controller 440) via the second port 418. In other words, the ventilation ridges 424, as described in further detail herein, can form discontinuities along one or more portions of the first contoured surface 421, which can, for example, prevent air from becoming trapped in localized regions between the flow controller 440 and one or more portions of the first contoured surface 421 by allowing air to flow freely between the flow controller 440 and one or more portions of the first contoured surface 421.

[0138]

[0154] As shown in FIGS. 24-27, the isolation portion 420 receives and / or is coupled to the outer shell member 425 such that the flow controller 440 is disposed between the isolation portion 420 and the outer shell member 425. In some embodiments, the outer shell member 425 may be substantially similar in form and / or function to the outer shell member 225 described above with respect to the device 200. For example, the contoured member 425 includes and / or forms a second contoured surface 426. The second contoured surface 426 may be of any suitable shape, curvature and / or texture and may be substantially similar to the second contoured surface 226 of the housing 220, for example. For example, the second contoured surface 426 includes and / or forms a first recess 427, a second recess 428 and a third recess 429. However, the second contoured surface 426 may differ from the second contoured surface 226 by including any number of ventilation channels 431, as shown in FIGS. 24-27. The distribution of ventilation channels 431 on the second contoured surface 426 can include a number of arrangements. For example, as shown in Figures 25 and 27, the second contoured surface 426 can be configured to have one ventilation channel 431, multiple ventilation channels 431, or multiple concentric ventilation channels 431 disposed within and / or formed by a first recess 427, and / or one ventilation channel 431, multiple ventilation channels 431, or multiple concentric ventilation channels 431 disposed within and / or formed by a second recess 428 of the second contoured surface 426. The ventilation channels 431 are configured to reduce and / or control the ability or likelihood of the flow controller 440, or a portion thereof, to form a seal when placed in contact with the second contoured surface 426 in response to a negative pressure (e.g., within the volume between the first contoured surface 421 and the flow controller 440), as discussed above with respect to the ventilation ridges 424.

[0139]

[0155] Although the first contoured surface 421 is described above as including ventilation ridges 424 and the second contoured surface 426 is described above as including ventilation channels 431, it should be understood that the ventilation ridges 424 and ventilation channels 431 are presented merely as examples and not as limitations. Various alternatives and / or combinations are contemplated. For example, in some embodiments, the first contoured surface 421 can include ventilation channels and the second contoured surface 426 can include ventilation ridges. In other embodiments, the first contoured surface 421 and / or the second contoured surface 426 can include a combination of ventilation channels and ventilation ridges. Thus, the contoured surfaces 421 and 426 can include one or more discontinuities having any suitable shape, size, and / or configuration that can enable and / or ensure that air can flow between the flow controller 440 and the contoured surfaces 421 and 426. Additionally, although each of contoured surfaces 421 and 426 are shown as including ventilation features or discontinuities, in other embodiments, the first contoured surface 421 can include ventilation features or discontinuities while the second contoured surface 426 does not, and vice versa.

[0140]

[0156] The flow controller 440 disposed within the isolated portion 420 of the housing 410 may be of any suitable shape, size, and / or configuration. Similarly, the flow controller 440 may be formed of any suitable material (e.g., any suitable biocompatible material, such as those described herein, and / or any other suitable material). For example, the flow controller 440 may be a fluid-impermeable bladder configured to transition from a first state and / or configuration to a second state and / or configuration. In some embodiments, the flow controller 440 (e.g., a bladder) may include any number of relatively thin and flexible portions configured to deform in response to a pressure differential across the flow controller 440. In some embodiments, the flow controller 440 may be substantially similar in form and / or function at least to the flow controller 240 described in detail above with reference to FIGS. 2-11. For example, in some embodiments, the flow controller 440 may be formed of or from any suitable material and / or have any suitable durometer hardness, such as the materials and / or durometer hardnesses described above with respect to the flow controller 240. Similarly, the flow controller 440 may have a size, shape, surface finish, and / or material properties configured to facilitate, promote, and / or otherwise provide fluid flow having a desired set of flow characteristics, as described above with respect to the flow controller 240. As such, portions of the flow controller 440 may not be described in further detail herein.

[0141]

[0157] 22-27, the flow controller 440 is a bladder formed of or from a silicone having a durometer hardness of about 30 Shore A. The flow controller 440 (e.g., a bladder) includes a first deformable portion 441, a second deformable portion 442, and a third deformable portion 443. Additionally, the flow controller 440 defines an opening 444 configured to receive at least a portion of the first port 417, as described above with respect to the flow controller 240. In some embodiments, the flow controller 440 can include one or more portions configured to form one or more seals with the flow controller 440 and each of the textured surfaces 421 and 426, and / or between the flow controller 440 and each of the textured surfaces 421 and 426. 24-27, for example, deformable portions 441, 442, and 443 of flow controller 440 correspond to and / or have substantially the same overall shape as at least a portion of contoured surfaces 421 and / or 426. Thus, as described in more detail herein, deformable portions 441, 442, and 443 and corresponding portions of contoured surfaces 421 and / or 426 can collectively form and / or define one or more volumes, or the like, which can further receive an initial volume of bodily fluid.

[0142]

[0158] As described above with respect to the flow controller 240, the flow controller 440 is configured to transition between a first state and a second state. For example, when the flow controller 440 is in its first state, the first deformable portion 441 can be disposed adjacent to and / or in substantial contact with a first recess 427 formed by the second uneven surface 426, the second deformable portion 442 can be disposed adjacent to and / or in substantial contact with a second recess 428, and the third deformable portion 443 can be disposed adjacent to and / or in substantial contact with a second recess 429 formed by the second uneven surface 426. Thus, a first portion of the isolation chamber 430 (e.g., a portion defined between the second uneven surface 426 and the first surface of the flow controller 440) can have a relatively small and / or relatively negligible volume. In contrast, when the flow controller 440 transitions from its first state to its second state (e.g., in response to negative pressure applied and / or transmitted via the second port 418), at least the deformable portions 441, 442, and 443 are disposed adjacent to and / or in substantial contact with the first uneven surface 421. More specifically, as described above with respect to the flow controller 240, the first deformable portion 421 can be disposed adjacent to and / or in substantial contact with a first recess 422 formed by the first uneven surface 421, the second deformable portion 442 can be disposed adjacent to and / or in substantial contact with a second recess 423 formed by the first uneven surface 421, and the third deformable portion 243 can be disposed adjacent to and / or in substantial contact with, e.g., a non-concave portion of the first uneven surface 421.

[0143]

[0159] The actuator 450 of the control device 400 may be of any suitable shape, size, and / or configuration. At least a portion of the actuator 450 is disposed within the actuator portion 412 of the housing 410 and is configured to transition between a first state, configuration, and / or position and a second state, configuration, and / or position. In the embodiment illustrated in Figures 22-27, the actuator 450 is configured as an actuator rod or plunger configured to move relative to the actuator portion 412 of the housing 410. The actuator 450 includes a set of seals 455 and defines a flow channel 452. The actuator 450 further includes an end 451 disposed outside the housing 410, the end 451 being configured to be actuated by a user to transition the actuator 450 between its first state in which the flow path 415 can establish fluid communication between the inlet 413 and the first port 417, and its second state in which (1) the first port 417 (and thus the isolation chamber 430) is isolated and / or fluidly separated, and (2) the inlet 413 and the outlet 414 are placed in fluid communication via at least a portion of the flow paths 415 and 416 and / or the flow channel 452 of the actuator 450. The actuator 450 is therefore similar in form and / or function to the actuator 250 described above with reference to Figures 2-11. The actuator 450 will therefore not be described in further detail herein.

[0144]

[0160] Device 400 can be used to obtain a sample of bodily fluid with reduced contamination (e.g., from microorganisms, e.g., skin-resident microorganisms, microorganisms external to the source of bodily fluid, etc.) in a manner substantially similar to that described above with respect to device 200. For example, prior to use, device 400 can be in its first, initial and / or storage state or mode of operation, with flow controller 440 and actuator 450 each in their respective first or initial state. With device 400 in the first state, a user, such as a doctor, physician, nurse, phlebotomist, technician, etc., can manipulate device 400 to establish fluid communication between inlet 413 and a source of bodily fluid (e.g., a patient's vein). Once inlet 413 is placed in fluid connection with the source of bodily fluid, outlet 414 can be fluidly coupled to a fluid collection device (not shown in FIGS. 22-27). In the embodiments shown in Figures 22-27, for example, the fluid collection device may be an evacuated blood collection tube, a culture bottle, a sample reservoir, a syringe, and / or any other suitable container or device configured to define or generate negative pressure, suction force, vacuum, and / or energy potential.

[0145]

[0161] When the actuator 450 is in a first position and / or configuration, the inlet 413 of the housing 410 is in fluid communication, for example, with a flow path 415, which is further in fluid communication with a first port 417. The outlet 414 of the housing 410 is in fluid communication with a flow path 416, which is further in fluid communication with a second port 418 (see, e.g., FIG. 24 ). As described in detail above, when the control device 400 is in a first state or mode of operation (e.g., when the actuator 450 and the flow controller 440 are each in their first state), fluidly coupling the fluid collection device to the outlet 414 creates and / or otherwise provides a negative pressure differential and / or suction force within at least a portion of the flow path 416 and also within a portion of the isolation chamber 430 defined between a surface (e.g., a first surface) of the flow controller 440 and the first contoured surface 421 of the housing 410.

[0146]

[0162] The flow controller 440 is in a first state and / or configuration prior to a fluid collection device being coupled to the outlet 414. In the embodiment illustrated in Figures 22-27, the flow controller 440 is a fluid impermeable bladder or the like that can have an inverted, inverted, collapsed, and / or empty configuration (e.g., the first state and / or configuration) prior to coupling a fluid collection device to the outlet 414. For example, as illustrated in Figures 24 and 25, when the flow controller 440 is in its first state and / or configuration, the flow controller 440 can be disposed adjacent to and / or in contact with the second contoured surface 426.

[0147]

[0163] As described above, the controller 440 is configured to transition from its first state and / or configuration to its second state and / or configuration in response to the creation of a negative pressure differential and / or suction force within a portion of the isolation chamber 430 defined between the flow controller 440 and the first contoured surface 421. For example, the flow controller 440 can be disposed adjacent to and / or in contact with the second contoured surface 426 when the flow controller 440 is in its first state (FIGS. 24 and 25), and can be transitioned, moved, "flipped," placed, and / or otherwise reconfigured into its second state in which the flow controller is disposed adjacent to and / or in contact with the first contoured surface 421. Additionally, the ventilation channels 431 formed by the second contoured surface 426 allow air to flow between the second contoured surface 426 and the flow controller 440, which in some examples can reduce the likelihood of pockets of air being trapped between the second contoured surface 426 and the flow controller 440 when and / or when positive pressure (e.g., positive pressure that drives and / or urges the flow controller 440 toward the second contoured surface 426, such as during manufacturing, testing and / or use) is applied within the volume between the flow controller 440 and the first contoured surface 421 via the port 418.

[0148]

[0164] When the actuator 450 is in its first state and the flow controller 440 is in its second state, the control device 400 is placed in its second state and / or configuration. The transition of the flow controller 440 causes an increase in the internal volume of the portion of the isolation chamber 430 defined between a surface of the flow controller 440 (e.g., a second surface opposite the first surface) and the second contoured surface 426. As described in detail above with respect to the device 200, the increase in internal volume can create a negative pressure differential between the portion of the isolation chamber 430 (defined at least in part by the flow controller 440) and, for example, the inlet 413, which is operable to draw at least a portion of an initial flow, amount, or volume of bodily fluid from the inlet 413 through the flow path 415 and the first port 417 into said portion of the isolation chamber 430. In some examples, an initial volume and / or flow of bodily fluid may be transferred into the isolation chamber 430, for example, until the flow controller 440 is fully inflated, inverted, and / or transitioned, until the negative pressure differential is reduced and / or equalized, and / or until a desired volume of bodily fluid is disposed within the isolation chamber 430. Additionally, as described above with respect to device 200, the restriction 419 may be configured to limit, restrict, control, and / or adjust the magnitude of the negative pressure differential and / or suction force generated within the isolation chamber 430 and / or against a surface of the flow controller 440, thereby adjusting the suction force within one or more flow paths and / or within a source of bodily fluid (e.g., a patient's vein). In other embodiments, the second port 418 and / or any suitable portion of the device 400 may be configured to adjust the suction force within one or more portions of the isolation chamber 30 in any suitable manner, such as, for example, as described above with respect to device 200.

[0149]

[0165] In some embodiments, the shape, size, and / or arrangement of the isolation chamber 430 and / or flow controller 440, ventilation channel 431, and / or ventilation ridge 424, the magnitude of the negative pressure differential or suction, and / or the manner in which the negative pressure differential or suction is applied can define and / or control the rate, sequence, and / or manner in which the flow controller 440 transitions from the first state to the second state. In some examples, the rate, sequence, and / or manner in which the flow controller 440 transitions can be controlled to provide one or more desired flow characteristics associated with the flow of air, gas, and / or bodily fluids into and / or through at least a portion of the isolation chamber. For example, an arrangement included in this embodiment can be one in which the transition and / or reversal of the third deformable portion 443 of the flow controller 440 is completed before the transition and / or reversal of the first deformable portion 441 and the second deformable portion 442 is completed. Additionally, the location of the ventilation ridges 424 along the first contoured surface 421 can increase the likelihood and / or ensure that the flow controller 440 will transition and / or flip in a desired manner or sequence by counteracting possible flow restrictions and / or seals that may otherwise prevent negative pressure differentials or suction forces from transitioning and / or flipping the portion of the flow controller 440 located opposite the restriction or seal.

[0150]

[0166] This arrangement may be such that a portion of the isolation chamber 430 collectively defined by the first deformable portion 441 and the first recess 427 of the second contoured surface 426 (e.g., a first volume of the isolation chamber 430) may receive at least a portion of a volume of air that was in the flow path between the source of bodily fluid and the isolation chamber 430 before the flow path received and / or filled with bodily fluid. Similarly, a portion of the isolation chamber 430 collectively defined by the second deformable portion 442 and the second recess 428 of the second contoured surface 426 (e.g., a second volume of the isolation chamber 430) may receive at least a portion of the volume of air that was in the flow path. Alternative arrangements of the isolation chamber 430 and / or flow controller 440 may be similar in form and function to those described above with respect to the isolation chamber 230 and / or flow controller 240, and therefore will not be described in further detail herein.

[0151]

[0167] Upon transfer of the initial volume of bodily fluid into the isolation chamber 430, a force may be applied to the end 451 of the actuator 450 to transition and / or place the actuator 450 into its second position, state, mode of operation and / or configuration, as described above. In some examples, the actuator 450 may be transitioned from a locked to an unlocked configuration or state prior to application of a force to the end 451 of the actuator 450. In the embodiments illustrated in FIGS. 22-27, the transition of the actuator 450 may be accomplished and / or may otherwise result from interaction and / or manipulation of the actuator 450 by a user. However, in other embodiments, the transition of the actuator 450 may occur automatically in response to negative pressure and / or associated flow dynamics within the device 400, and / or may be effected by or in response to an external energy source that generates one or more dynamics or conditions that result in the transition of the actuator 450.

[0152]

[0168] 26 and 27, when the flow controller 440 and the actuator 450 are each in their second state, the control device 400 is placed in its third state. When the actuator 450 transitions from its second state, position, and / or configuration, the inlet 413 and the outlet 414 are placed in a fluidly connected state (e.g., via the flow path 416 and / or the flow channel 452), while the flow path 415 and / or the first port 417 are isolated, separated, and / or otherwise not in fluid communication with the inlet 413 and / or the outlet 414. Thus, the initial volume of bodily fluid is isolated within a portion of the isolation chamber 430. Furthermore, in some examples, contaminants, such as, for example, skin-resident microorganisms and / or any other contaminants, may be entrained and / or contained within the initial volume of bodily fluid and thus be isolated within the isolation chamber 430 when the initial volume is isolated within the isolation chamber 430. Thus, negative pressure that would otherwise be applied on or through flow path 416 and through second port 418 is now applied to or through outlet 414 and inlet 413, e.g., via flow paths 415 and 416 and / or at least a portion of flow channel 452 of actuator 450. In response, bodily fluid can flow from inlet 413, through actuator portion 412 of housing 410, through outlet 414, and into a fluid collection device coupled to outlet 414. Device 400 can thus function in a substantially similar manner as devices 100 and / or 200, described in detail above.

[0153]

[0169] 28, a flow chart is presented illustrating a method 10 of using a fluid control device to obtain a sample of a bodily fluid with reduced contamination, according to one embodiment. The fluid control device may be similar and / or substantially identical to any of the fluid control devices 100, 200, 300 and / or 400 described in detail above. Thus, the fluid control device (also referred to herein as a "control device" or "device") may include a housing, a flow controller and an actuator. The method 10 includes, at 11, establishing fluid communication between a source of bodily fluid and an inlet of the housing. For example, in some embodiments, a user may manipulate the fluid control device to physically and / or fluidly couple the inlet to a lumen-containing device (e.g., a needle, IV, PICC line, etc.), which is further in fluid communication with a patient. In other embodiments, the source of bodily fluid may be a source of bodily fluid other than the patient (e.g., a reservoir, a container, etc.).

[0154]

[0170] At 12, a fluid collection device is coupled to the outlet of the housing. The coupling of the fluid collection device to the outlet is configured to provide and / or otherwise generate a negative pressure differential within at least a portion of the fluid control device, as described in detail above with respect to devices 100, 200, 300 and / or 400. In some embodiments, for example, the fluid collection device may be a vacuum blood collection tube, a sample or culture bottle defining a negative pressure, a syringe, or the like. In response to a suction force applied to the fluid collection device, the flow controller of the control device transitions from a first state to a second state at 13 to increase a volume of an isolation chamber collectively defined by the flow controller and a portion of the housing. For example, in some embodiments, the flow controller may be a fluid impermeable bladder, or the like, similar to flow controllers 240, 340 and / or 440 described in detail above, disposed within the isolation chamber.

[0155]

[0171] The flow controller (e.g., a bladder) can define any number of deformable portions configured to shift, deform, flip, and / or otherwise reconfigure in response to suction forces. In some embodiments, a first portion of the isolation chamber can be associated with and / or at least partially defined by a first deformable portion of the flow controller, and a second portion of the isolation chamber can be associated with and / or at least partially defined by a second deformable portion of the flow controller. In some embodiments, the arrangement of the flow controller within the isolation chamber can be such that the first and second portions of the isolation chamber are on a first side of the flow controller (e.g., a fluid-impermeable bladder), and a third portion of the isolation chamber is on a second side opposite the first side of the flow controller. As described above with respect to at least devices 200, 300 and / or 400, the arrangement of the housing, flow controller and actuator may be such that when the actuator is in a first state and / or configuration, the inlet is in fluid communication with a first and / or second portion of the isolation chamber (e.g., via a port similar to the first port 217, 317 and / or 417 described above) and the outlet is in fluid communication with a third portion of the isolation chamber (e.g., via a port similar to the second port 217, 317 and / or 417 described above). Thus, the third portion of the isolation chamber may be exposed to at least a portion of a suction force generated by the fluid collection device, which suction force is operable to transition the fluid controller from its first state to its second state.

[0156]

[0172] At 14, the first portion of the isolation chamber receives a volume of air contained in a flow path defined between the source of bodily fluid and the isolation chamber in response to an increase in the volume of the isolation chamber. For example, in some embodiments, the inlet of the housing can be fluidly coupled to a needle or lumen-containing device, which is further inserted into a portion of the patient. Thus, the flow path can be collectively defined, for example, by a lumen of the needle or lumen-containing device, a lumen of the inlet of the housing, and one or more flow paths, channels, openings, ports, etc., defined by the housing. In other words, the control device can be configured to purge air from the flow path prior to transferring the bodily fluid to the isolation chamber.

[0157]

[0173] In some embodiments, the first portion of the isolation chamber can be, for example, a center or central portion of the isolation chamber. In some embodiments, the first portion of the isolation chamber can be collectively formed by any number of regions, volumes, and / or compartments (e.g., similar to isolation chambers 230 and / or 430 described above). In other embodiments, the first portion of the isolation chamber can be a single and / or contiguous portion (e.g., similar to isolation chamber 330 described above). In still other embodiments, the first portion of the isolation chamber and the second portion of the isolation chamber can be "in-line," such that the entire isolation chamber or substantially the entire isolation chamber is a single and / or contiguous volume. For example, in some embodiments, the isolation chamber can have a shape and / or configuration similar to those described in detail in U.S. Patent Application Publication No. 2019 / 0076074, entitled "Fluid Control Devices and Methods of Using the Same," filed September 12, 2018 (referred to herein as the "'074 Publication"), the disclosure of which is incorporated herein by reference in its entirety.

[0158]

[0174] At 15, the second portion of the isolation chamber receives an initial volume of bodily fluid in response to the increase in the volume of the isolation chamber. More specifically, the second portion of the isolation chamber can receive the initial volume of bodily fluid after the first portion of the isolation chamber receives the volume of air. In some embodiments, the initial volume of bodily fluid can be a volume sufficient to substantially fill the second portion of the isolation chamber. In other embodiments, the initial volume of bodily fluid can be a volume or amount of bodily fluid that flows into the second portion of the isolation chamber while a negative pressure differential (e.g., resulting from the increase in volume) is less than a threshold magnitude or amount. In other embodiments, bodily fluid can flow into the second portion of the isolation chamber until pressures in the isolation chamber and / or in the flow path between the bodily fluid source and the isolation chamber are equalized. In still other embodiments, the initial volume can be any suitable amount or volume of bodily fluid, such as any of the amounts or volumes detailed herein. In some examples, the filling or substantial filling of the second portion of the isolation chamber can be operable to sequester, retain, and / or fluidically lock the volume of air in the first portion of the isolation chamber.

[0159]

[0175] After receiving the initial volume of bodily fluid, at 16, the actuator of the device transitions from a first configuration to a second configuration to (1) isolate the isolation chamber and (2) allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force. In some embodiments, the actuator can transition from the first state to the second state to automatically isolate the initial volume of bodily fluid within the isolation portion. In other embodiments, the actuator can transition from the first state to the second state in response to a force applied by a user, as described above with respect to actuators 250, 350 and / or 450. For example, in some embodiments, the actuator can be a rod or plunger including one or more seals or the like that can (1) fluidly isolate at least a portion of the flow path between the inlet and the isolation chamber, (2) fluidly isolate at least a portion of the flow path between the outlet and the isolation chamber, and (3) establish fluid communication between the inlet and the outlet to allow a subsequent volume of bodily fluid to flow therebetween.

[0160]

[0176] With the fluid collection device fluidly coupled to the outlet of the housing, a subsequent volume of bodily fluid (e.g., one or more sample volumes) can be conveyed into the fluid collection device and used in any suitable test, such as, for example, those described herein. As described in detail above, in some examples, isolating the initial volume of bodily fluid in an isolated portion of the device can isolate any contaminants contained within the initial volume. Thus, contaminants in the subsequent volume of bodily fluid that could otherwise result in erroneous or inaccurate results in the test can be reduced or substantially eliminated.

[0161]

[0177] While various embodiments have been described above, it should be understood that they are presented by way of example only and not by way of limitation. Where the schematic diagrams and / or embodiments described above show certain components arranged in certain orientations or positions, the arrangement of those components may be changed. Although embodiments have been specifically shown and described, it will be understood that various changes in form and detail may be made. Although various embodiments have been described as having particular features, concepts and / or combinations of components, other embodiments are possible having any combination or subcombination of any of the features, concepts and / or components from any of the embodiments described herein.

[0162]

[0178] In some embodiments, the specific configuration of the various components may also be changed. For example, the size and specific shape of the various components may differ from the illustrated embodiment while still providing the functionality as described herein. In some embodiments, the size and / or shape of such components may be changed to reduce the overall size of the device and / or improve the ergonomics of the device without changing the functionality of the device. In some embodiments, the size and / or shape of the various components may be specifically selected for a desired or intended use. For example, in some embodiments, a device such as those described herein may be configured for use in or with a seemingly healthy adult patient. In such embodiments, the device may include a sequestration chamber having a first volume (e.g., about 0.5 ml to about 5.0 ml). In other embodiments, a device such as those described herein may be configured for use in or with a critically ill and / or pediatric patient, for example. In such embodiments, the device may include a sequestration chamber having a second volume smaller than the first volume (e.g., less than about 0.5 ml). Thus, unless expressly stated otherwise by the context, it should be understood that the size, shape and / or arrangement of the embodiments and / or their components may be adapted for a given use.

[0163]

[0179] Any of the embodiments described herein may be used with any suitable fluid transfer, fluid collection and / or fluid storage device, such as, for example, the fluid reservoirs described in the '420 patent. In some cases, any of the embodiments described herein may be combined with, for example, devices described in the '783 patent, the '510 publication, the '074 publication, and / or U.S. Pat. No. 8,535,241, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed Oct. 22, 2012; U.S. Pat. No. 9,060,724, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed May 29, 2013; U.S. Pat. No. 9,155,495, entitled "Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed Dec. 2, 2013; U.S. Pat. No. 9,155,495, entitled "Devices and Methods for Syringe Based Fluid Transfer for Bodily-Fluid Sampling," filed Jun. 23, 2016; No. 2016 / 0361006, entitled "Systems and Methods for Sample Collection with Reduced Hemolysis," filed Nov. 20, 2017; U.S. Patent Application Publication No. 2018 / 0140240, entitled "Systems and Methods for Sample Collection with Reduced Hemolysis," filed Nov. 20, 2017; and / or U.S. Patent No. 9,950,084, entitled "Apparatus and Methods for Maintaining Sterility of a Specimen Container," filed Sep. 6, 2016, the disclosures of which are incorporated by reference in their entireties herein.

[0164]

[0180] Although control devices 100, 200, 300 and / or 400 are described as transferring bodily fluid into the device as a result of negative pressure in the fluid collection device, in other embodiments, the devices described herein can be used with any suitable device configured to establish a negative pressure differential, suction, etc., such as, for example, a syringe or pump. In other embodiments, the control device can include a pre-loaded isolation chamber, an evacuated isolation chamber, a manually activated device configured to generate negative pressure, an energy source (e.g., a chemical energy source, a kinetic energy source, etc.), and / or any other suitable means of defining and / or creating a pressure differential within a portion of the control device. Additionally, the control device can be coupled to such collection devices by a user (e.g., a doctor, nurse, technician, physician, etc.) or can be coupled or assembled during manufacture. In some embodiments, pre-assembly of the control device and collection device (e.g., a sample container or syringe) can enforce compliance with a sample acquisition protocol that requires, for example, isolation of an initial amount of bodily fluid before collecting a sample volume of bodily fluid.

[0165]

[0181] While some of the embodiments described above include flow controllers and / or actuators having a particular configuration and / or arrangement, in other embodiments, the fluid control device can include any suitable flow controller and / or actuator configured to selectively control the flow of bodily fluids through one or more portions of the fluid control device. For example, some embodiments include an actuator having one or more seals arranged as an O-ring or elastomeric overmold that moves with the actuator and relative to a portion of the device (e.g., an inner surface of a housing, etc.), while in other embodiments, the fluid control device can include one or more seals having any suitable configuration. For example, in some embodiments, the fluid control device can include one or more seals arranged as elastomeric sheets or the like that are fixedly coupled to a portion of the control device. In such embodiments, a portion of the actuator, such as a pin or rod, can extend through an opening defined in the one or more elastomeric sheets, and the one or more elastomeric sheets form a substantially fluid-tight seal with an outer surface of the pin or rod. Thus, at least a portion of the actuator can move relative to the one or more elastomeric sheets, which remain in a substantially fixed position relative to said portion of the control device. In some embodiments, removing the portion of the actuator from the opening defined by the one or more elastomeric sheets can allow fluid flow through the opening that was originally blocked by that portion of the actuator. Thus, the one or more elastomeric sheets can function in a manner similar to any of the seals described herein. Additionally, in some embodiments, such an arrangement can reduce the amount of friction associated with forming a desired fluid-tight seal, for example, which can further avoid the use of lubricants that would otherwise be used to facilitate movement of the seal within the control device.

[0166]

[0182] In some embodiments, the device and / or flow controller may include one or more vents, membranes, members, semi-permeable barriers, etc., configured to at least partially control the flow of fluid through the device, flow controller, and / or actuator. For example, while a portion of the isolation chamber 230 is described above as receiving and holding a volume of air that has been exhausted, evacuated, and / or purged from the flow path between the source of bodily fluid and the isolation chamber 230, in other embodiments, the isolation chamber 230 may include a vent or selectively permeable membrane configured to allow air to exit the isolation chamber 230. For example, in some embodiments, the bladder or diaphragm (or a portion thereof) may be formed of or from a semi-permeable material that allows air to flow but not bodily fluids. In other embodiments, a semi-permeable material may be disposed in or along the flow path between the isolation chamber and at least one of the outlet or inlet to selectively allow air and / or bodily fluids to flow therebetween. In some embodiments, the fluid control device can include semi-permeable members and / or membranes that can be similar in form and / or function to the semi-permeable members and / or membranes (e.g., flow controllers) described in the '074 publication incorporated by reference above.

[0167]

[0183] Although flow controllers 240, 340, and 440 have been described as being bladders configured to transition, move, reverse, and / or otherwise reconfigure in response to an amount of negative pressure exceeding a threshold amount of negative pressure being applied to a surface of the bladder, in other embodiments, the fluid control device can include any suitable flow controller, actuator, semi-permeable (e.g., air permeable and liquid impermeable) member, etc., configured to transition, move, reverse, and / or otherwise reconfigure in any suitable manner in response to exposure to a desired and / or predetermined amount of negative pressure. In other embodiments, the control device can include a bladder (or flow controller) that is configured to reverse (e.g., transition relatively rapidly and / or substantially uniformly) from a first state to a second state, or to transition gradually (e.g., unfold (from a rolled state), unfold (from a folded state), unfold (from a collapsed state), and / or otherwise reconfigure) in response to exposure to a negative pressure differential. In some examples, controlling the rate at which the bladder (or flow controller) transitions can allow for adjustment and / or control of the negative pressure differential created within the isolation chamber, and thus the magnitude of suction force applied within the patient's vein and / or other suitable bodily fluid source.

[0168]

[0184] Although some of the embodiments described above include a flow controller and / or actuator that physically and / or mechanically isolates one or more portions of the fluid control device, in other embodiments, the fluid control device need not physically and / or mechanically isolate one or more portions of the fluid control device. For example, in some embodiments, an actuator such as actuator 250 can be transitioned from a first state in which an initial volume of bodily fluid can flow from an inlet to an isolated chamber or portion to a second state in which (1) the isolated chamber or portion is physically and / or mechanically isolated and (2) the inlet is in fluid communication with an outlet of the fluid control device. However, in other embodiments, the actuator and / or any other suitable portion of the fluid control device can be transitioned from a first state in which an initial volume of bodily fluid can flow from an inlet to an isolated chamber or portion to a second state in which the inlet is placed in fluid communication with the outlet without physically and / or mechanically isolating (or isolating) the isolated chamber or portion. When such a control device is in a second state, one or more features and / or geometric shapes of the control device may allow preferential flow of bodily fluid from the inlet to the outlet and may retain an initial volume of bodily fluid within the isolation chamber or portion without being physically and / or mechanically isolated or separated.

[0169]

[0185] Although the restriction 219 is described above as regulating and / or controlling the amount of negative pressure applied on or through at least a portion of the device 200 (e.g., in the isolation chamber 230 and / or otherwise on the flow controller 240), in other embodiments, the control device may include any suitable features, mechanisms and / or devices configured to regulate, provide and / or otherwise control one or more pressure differentials through at least a portion of the control device. For example, in some embodiments, a user may transition and / or move an actuator to change (e.g., reduce or increase) the size of one or more portions of a flow path or fluid flow interface within a portion of the control device to manually regulate and / or otherwise control the amount and magnitude of negative pressure within one or more portions of the control device.

[0170]

[0186] Although not shown, any of the devices described herein may include an opening, port, coupler, septum, Luer-Lok, gasket, valve, threaded connector, standard fluid interface, etc. (referred to as a "port" for simplicity) that is in fluid communication with the isolation chamber. In some such embodiments, the port may be configured to couple to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the port may be configured to couple to a reservoir, which may allow a larger volume of bodily fluid to be diverted and / or transferred to the isolation chamber. In other embodiments, the port may be coupled to a negative pressure source, such as a vacuum blood collection tube, pump, syringe, etc., to collect a portion or the entire volume of the bodily fluid within the isolation chamber, channel, reservoir, etc., which may then be used for further clinical and / or in vitro diagnostic testing purposes. In other embodiments, the port can be configured to accept a probe, sample collection tool, testing device, etc. that can be used to perform one or more tests (e.g., tests that are not susceptible to potential contamination) on the initial volume while it is disposed or isolated within the isolation chamber. In still other embodiments, the port can be coupled to any suitable pressure source or infusion device configured to infuse the initial volume of bodily fluid isolated within the isolation chamber back into the patient's body and / or into the source of bodily fluid (e.g., in the case of pediatric patients, critically ill patients, patients with low blood volume, etc.). In other embodiments, the isolation channel, chamber, and / or reservoir can be configured to allow the initial bodily fluid to be used for testing with the addition of other diagnostic testing components (e.g., dipstick tests) integrated within the chamber.

[0171]

[0187] In yet other embodiments, the isolation chambers, channels and / or reservoirs can be designed, sized and configured to be removable and compatible with testing equipment and / or specifically accessible for other types of bodily fluid testing commonly performed on patients suspected of having a medical condition. By way of example, patients suspected of having sepsis commonly have blood samples collected for lactate testing, procalcitonin testing and blood culture testing. All of the fluid control devices described herein can be configured such that the isolation chambers, channels, reservoirs, etc. can be removed (e.g., after receiving an initial volume of bodily fluid) and the bodily fluid contained therein can be used for these additional testing purposes before or after a subsequent sample is collected for microbiological testing.

[0172]

[0188] Although not shown, in some embodiments, the fluid control device can include one or more lumens, channels, flow paths, etc. configured to selectively allow a "bypass" flow of bodily fluid, where an initial amount or volume of bodily fluid can flow from an inlet through a lumen, channel, flow path, etc. into the collection device to bypass the isolation chamber. In some embodiments, the fluid control device can include an actuator having, for example, at least three states: a first state in which bodily fluid can flow from the inlet to the isolation chamber, a second state in which bodily fluid can flow from the inlet to the outlet after the initial volume is isolated in the isolation chamber, and a third state in which bodily fluid can flow from the inlet through the bypass flow path to the outlet. In other embodiments, the control device can include a first actuator configured to transition the device between the first and second states, as described in detail above with respect to specific embodiments, and can include a second actuator configured to transition the device to a bypass configuration, etc. In still other embodiments, the control device can include any suitable device, feature, component, mechanism, actuator, controller, etc. configured to selectively place the fluid control device in a bypass configuration or state.

[0173]

[0189] In some embodiments, a method of using a fluid control device such as those described herein can include sequencing the establishment of fluid communication between a bodily fluid source (e.g., a patient's vein, etc.) and an inlet of the fluid control device. An outlet of the fluid control device is then placed in fluid connection with and / or otherwise engaged with a negative pressure source. Such a negative pressure source can be a sample reservoir, a syringe, a vacuum blood collection tube, an intermediate transfer device, etc. The fluid control device can be in a first state or mode of operation when the outlet is coupled to the negative pressure source, thus applying a negative pressure differential through the fluid control device that draws an initial volume of bodily fluid into an isolation chamber of the fluid control device. For example, the negative pressure in the sample reservoir can be operable in drawing an initial volume of bodily fluid from the patient into the isolation chamber. Once the initial volume of bodily fluid is located in the isolation chamber, the fluid control device transitions, either automatically or via user intervention, from the first state or mode of operation to a second state or mode of operation such that (1) the initial volume is isolated in the isolation chamber and (2) fluid communication is established between the inlet and the outlet. The isolation of the initial volume may be such that any contaminants entrained in the initial volume of flow are similarly isolated in the isolation chamber. With the initial volume of bodily fluid isolated in the isolation chamber and with fluid communication established between the inlet and the outlet, a subsequent volume of bodily fluid that is substantially free of contamination may be collected in one or more sample reservoirs.

[0174]

[0190] Although the method of using the fluid control device is explicitly described as including the recited ordering, in other embodiments, the ordering of some events and / or steps in any of the methods or processes described herein may be altered, and such alterations are in accordance with variations of the present invention. Additionally, some events and / or steps may be performed simultaneously in a parallel process, where possible, as well as sequentially as described above. Some steps may be partially completed or omitted before proceeding to a subsequent step. For example, while the device is described herein as transitioning from a first state to a second state, such as in a discontinuous operation, it should be understood that the devices described herein may be configured to transition from the first state to the second state automatically and / or passively, and such transition may occur over a period of time. In other words, the transition from the first state to the second state may be relatively gradual, such that in some examples, the housing begins transitioning from the first state to the second state when at least a portion of the initial volume of bodily fluid has been transferred into the isolation chamber. In some examples, the rate of change when transitioning from the first state to the second state may be selectively controlled to achieve one or more desired characteristics associated with the transition. Moreover, in some such instances, the entry of the final portion of the initial volume can limit and / or substantially prevent bodily fluid already disposed within the isolation chamber from escaping therefrom. Thus, although the transition from the first state to the second state can occur over a given amount of time, the isolation chamber can nevertheless isolate the volume of bodily fluid disposed therein.

Claims

1. 1. A device for collecting a sample of a body fluid with minimal contamination, comprising: a housing forming at least a portion of a sequestration chamber, the housing having an inlet configured to be fluidly connected to a source of bodily fluid and an outlet configured to be fluidly connected to a fluid collection device, the fluid collection device applying a suction force within at least a portion of the housing when fluidly connected to the outlet; an actuator coupled to the housing, the actuator having a first configuration in which the inlet is in fluid communication with the sequestration chamber and a second configuration in which the inlet is in fluid communication with the outlet and is fluidly isolated from the sequestration chamber; a flow controller disposed within the housing and defining a portion of the segregation chamber, the flow controller having a first state in which the portion of the segregation chamber has a first volume and a second state in which the portion of the segregation chamber has a second volume greater than the first volume; Equipped with the actuator, when in the first configuration, fluidly connects the inlet to a first side of the flow controller through a first flow path and the outlet to a second side of the flow controller through a second flow path, the flow controller transitioning from the first state to the second state in response to the suction force to draw an initial volume of the bodily fluid into the portion of the isolation chamber; the actuator is configured to transition to the second configuration after the initial volume of bodily fluid is drawn into the isolation chamber to (1) isolate the isolation chamber from the inlet and (2) fluidly connect a portion of the first flow path with a portion of the second flow path to allow a subsequent volume of the bodily fluid to flow from the inlet to the outlet in response to the suction force.

2. the housing includes a first port and a second port; 2. The device of claim 1, wherein the actuator in the first configuration places the first port in fluid communication with the inlet of the isolation chamber and places the second port in fluid communication with the outlet of the isolation chamber.

3. 2. The apparatus of claim 1, wherein the flow controller comprises a plurality of deformable portions, the deformation of each of the plurality of deformable portions being configured in response to the suction force to transition the flow controller from the first state to the second state.

4. 2. The device of claim 1, wherein a cross-sectional area of ​​the portion of the isolation chamber when in the second state limits mixing of the initial volume of the bodily fluid with a volume of air drawn into the portion of the isolation chamber.

5. 2. The device of claim 1, wherein the portion of the isolation chamber is a first portion of the isolation chamber defined at least in part by a first deformable portion of the flow controller, and a second portion of the isolation chamber defined at least in part by a second deformable portion of the flow controller configured to receive a volume of air before the first portion of the isolation chamber receives the initial volume of the bodily fluid.

6. 6. The device of claim 5, wherein the first and second deformable portions are configured to deform in response to the suction force, the first deformable portion deforms before the bodily fluid flows into the first portion of the isolation chamber, and at least a portion of the second deformable portion deforms after the first deformable portion deforms.

7. 2. The apparatus of claim 1, wherein in the first state, the flow controller has a first side of the flow controller in contact with at least a portion of a first surface of the isolation chamber, and in the second state, the flow controller has a second side of the flow controller in contact with at least a portion of a second surface of the isolation chamber, the second surface being opposite the first surface.

8. 8. The apparatus of claim 7, wherein the flow controller in the first state defines at least one channel configured to allow air flow to pass between the first surface of the isolation chamber and the first side of the flow controller.

9. 8. The apparatus of claim 7, wherein the flow controller in the second state defines at least one ridge configured to allow air flow to pass between the second surface of the isolation chamber and the second side of the flow controller.

10. 8. The apparatus of claim 7, wherein the flow controller is a fluid impermeable bladder, and the portion of the isolation chamber is a first portion of the isolation chamber defined between the first surface of the isolation chamber and the first side of the fluid impermeable bladder and a second portion of the isolation chamber defined between the second surface of the isolation chamber and the second side of the fluid impermeable bladder.

11. 11. The device of claim 10, wherein a volume of the second portion of the isolation chamber is approximately equal to the second volume when the fluid impermeable bladder is in the first state and is approximately equal to the first volume when the fluid impermeable bladder is in the second state.

12. 1. A device for collecting a sample of a body fluid with minimal contamination, comprising: a housing forming at least a portion of a sequestration chamber, the housing having an inlet configured to be fluidly connected to a source of bodily fluid and an outlet configured to be fluidly connected to a fluid collection device, the fluid collection device applying a suction force within at least a portion of the housing when fluidly connected to the outlet; an actuator coupled to the housing, the actuator having a first configuration in which the inlet and the isolation chamber are fluidly connected through a first flow path, and a second configuration in which the inlet and the outlet are fluidly connected through a second flow path and are fluidly isolated from the isolation chamber; a flow controller disposed within the housing and defining a portion of the isolation chamber, the flow controller having a first state in which a first side of the flow controller contacts at least a portion of a first surface of the isolation chamber and a second state in which a second side of the flow controller contacts at least a portion of a second surface of the isolation chamber, the second surface being opposite the first surface; Equipped with the flow controller transitions from the first state to the second state as a result of the suction force being applied to the second side of the flow controller, drawing an initial volume of the bodily fluid into a portion of the isolation chamber defined between the first surface and the first side of the flow controller; the actuator is configured to transition to the second configuration after the initial volume of the bodily fluid is drawn into the portion of the isolation chamber to (1) isolate the isolation chamber from the inlet and (2) fluidly connect a portion of the first flow path with a portion of the second flow path to allow a subsequent volume of bodily fluid to flow from the inlet to the outlet in response to the suction force.

13. The device of claim 12 , wherein the flow controller is a fluid impermeable bladder.

14. The apparatus of claim 12 , wherein the flow controller is a fluid impermeable diaphragm.

15. 13. The device of claim 12, wherein the portion of the isolation chamber is a first portion of the isolation chamber defined at least in part by a first deformable portion of the flow controller, and a second portion of the isolation chamber defined at least in part by a second deformable portion of the flow controller, configured to receive a volume of air before the first portion of the isolation chamber receives the initial volume of bodily fluid.

16. the first surface of the isolation chamber defines at least one discontinuity configured to permit airflow between the first surface of the isolation chamber and the first side of the flow controller when the flow controller is in a first state; 13. The apparatus of claim 12, wherein the second surface of the isolation chamber forms at least one discontinuity configured to allow air flow between the second surface of the isolation chamber and the second side of the flow controller when the flow controller is in a second state.

17. the portion of the isolation chamber is a first portion defined between the first surface of the isolation chamber and the first side of the flow controller, and a second portion of the isolation chamber is defined between a second surface of the isolation chamber and the second side of the flow controller; The housing and the actuator in the first configuration (i) define the first flow path between the first portion of the sequestration chamber and the inlet, and (ii) define a second flow path between the second portion of the sequestration chamber and the outlet; The apparatus of claim 15 , wherein the housing and the actuator in the second configuration define a third flow path between the inlet and the outlet.

18. 20. The apparatus of claim 17, wherein the actuator in the second configuration fluidly isolates the first portion of the isolation chamber from the inlet and fluidly isolates the second portion of the isolation chamber from the outlet.

19. 20. The apparatus of claim 18, further comprising a flow restriction disposed within a portion of the second flow path, the flow restriction configured to reduce a magnitude of the suction force applied to the second side of the flow controller.

20. 1. A method for obtaining a sample of a body fluid with reduced contamination using a fluid control device having a housing, an actuator, and a flow controller, comprising: fluidly connecting a source of bodily fluid to an inlet of the housing; connecting a fluid collection device to an outlet of the housing, the fluid collection device applying a suction force within at least a portion of the housing when coupled to the outlet; transitioning the flow controller from a first state to a second state in response to the suction force to increase a volume of an isolation chamber defined by the flow controller and the portion of the housing; receiving, in response to the increase in volume, into a first portion of the sequestration chamber, a volume of air contained within a first flow path defined between the inlet and the sequestration chamber; receiving an initial volume of the bodily fluid within a second portion of the isolation chamber in response to the increase in volume; after receiving the initial volume of the bodily fluid into the second portion of the isolation chamber, transitioning the actuator from a first configuration in which the inlet and the isolation chamber are fluidly connected through the first flow path to a second configuration in which the inlet and the outlet are fluidly connected through a second flow path to (1) isolate the isolation chamber and (2) fluidly connect a portion of the first flow path with a portion of the second flow path to allow a subsequent volume of the bodily fluid to flow from the inlet to the outlet in response to the suction force; A method comprising:

21. 21. The method of claim 20, wherein the flow controller is a bladder including a plurality of deformable portions, each deformable portion of the plurality of deformable portions configured to deform in response to the suction force to transition the bladder from the first state to the second state.

22. 22. The method of claim 21 , wherein the first portion of the isolation chamber is at least partially defined by a first deformable portion of the plurality of deformable portions and the second portion of the isolation chamber is at least partially defined by a second deformable portion of the plurality of deformable portions.

23. 23. The method of claim 22, wherein the second of the plurality of deformable portions is fully deformed before the first of the plurality of deformable portions is fully deformed.

24. 21. The method of claim 20, wherein the first and second portions of the isolation chamber are on a first side of the flow controller, and the isolation chamber has a third portion disposed on a second side of the flow controller opposite the first side.

25. 25. The method of claim 24, wherein the actuator in the first configuration fluidly connects between (1) the inlet and the first and second portions of the sequestration chamber, and (2) the outlet and the third portion of the sequestration chamber.

26. 21. The method of claim 20, wherein the first and second portions of the isolation chamber are defined between a first surface of the isolation chamber and a first side of the flow controller, and the isolation chamber has a third portion defined between a second surface of the isolation chamber and a second side of the flow controller, the second surface being opposite the first surface and the second side being opposite the first side.

27. The fluid control device includes a flow restrictor disposed in a third flow path defined between the third portion of the isolation chamber and the outlet when the actuator is in the first configuration, and the method further comprises:

27. The method of claim 26, further comprising adjusting the suction force applied to the second side of the flow controller when the actuator is in the first configuration.

28. 27. The method of claim 26, wherein the first surface of the isolation chamber forms at least one discontinuity configured to allow air flow to pass between the first surface of the isolation chamber and the first side of the flow controller when the flow controller is in the first state.

29. 27. The method of claim 26, wherein the second surface of the isolation chamber forms at least one discontinuity configured to allow air flow to pass between the second surface of the isolation chamber and the second side of the flow controller when the flow controller is in the second state.

30. The apparatus of claim 1 , wherein the suction force is applied through the second flow path by the fluid collection device.

31. The apparatus of claim 12 , wherein the suction force is applied through the second flow path by the fluid collection device.

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