Fluid control device and method of use

Abstract

To provide a device and method for procuring a body fluid sample in which microorganisms present on the skin and / or other contaminants external to the body fluid source are reduced.SOLUTION: The fluid control device (200) includes an inlet (212) to be placed in fluid communication with a source of bodily fluid and an outlet (216) to be placed in fluid communication with a fluid collection device to create a negative pressure differential between the outlet and the inlet. The isolated portion (214) is in fluid communication with the inlet and includes a first flow controller (222) that transitions from a first state to a second state to place the isolated portion in fluid communication with the outlet when the negative pressure differential has a first magnitude. The sampling portion (224) is in fluid communication with the outlet and includes a second flow controller (221) that transitions from a first state to a second state to place the sampling portion in fluid communication with the inlet when the negative pressure differential has a second magnitude.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 678,637, entitled "Fluid Control Devices and Methods of Using the Same," filed May 31, 2018, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] The present invention relates generally to obtaining bodily fluid samples, and more particularly to fluid diversion, segregation, and / or isolation devices, and devices and methods for obtaining bodily fluid samples with reduced contaminants, such as microorganisms present on the skin, and / or other contaminants external to the source of the bodily fluid.

[0003] Healthcare practitioners routinely perform a wide variety of microbial and 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 clinicians continue to increase. Maintaining the integrity of bodily fluid samples during and / or after collection also ensures that analytical diagnostic results represent the patient's in vivo state. Examples of diagnostic technologies that rely on high-quality, uncontaminated, and / or pure 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, and / or the like.

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

[0005] In some examples, devices and / or systems can be used to reduce the likelihood of contamination, adulteration, and / or the like of bodily fluid samples for testing. For example, some known devices can be configured to collect, divert, separate, and / or segregate (e.g., isolate) an initial volume of bodily fluid that is likely to contain contaminants, such as microorganisms present on the skin. However, some such devices may be perceived as cumbersome, unintuitive, or difficult to use, or may be inappropriate or unavailable for the intended patient population. Furthermore, some such devices may require training, user observation, multiple user interventions, and / or otherwise present challenges that may limit their effectiveness. In some examples, these and / or other challenges complicate the collection of consistently high-quality samples, such as those that are uncontaminated, sterile, and pure, which in turn may affect the validity of test results.

[0006] Thus, there is a need for fluid control and / or diversion devices and methods for obtaining fluid samples with reduced contaminants, such as microorganisms present on the skin and / or other contaminants present outside the source of the fluid, that result in consistent fluid collection (e.g., from general and / or difficult patient populations). Additionally, there is a need for devices and methods that can include, for example, fluid collection using various sources of external energy and / or negative pressure. Summary of the Invention

[0007] Described herein are devices and methods for obtaining a bodily fluid sample with reduced contaminants, such as microorganisms present on the skin and / or other contaminants external to the bodily fluid source. In some embodiments, the fluid control device includes an inlet and an outlet. The inlet is configured to be placed in fluid communication with a bodily fluid source, and the outlet is configured to be placed in fluid communication with a fluid collection device. Coupling the outlet to the fluid collection device can create a negative pressure difference within the fluid control device between the outlet and the inlet. The fluid control device has an isolation portion in fluid communication with the inlet and a sampling portion in fluid communication with the outlet. The isolation portion includes a first flow controller configured to transition from a first state in which the isolation portion is isolated from the outlet to a second state in which the isolation portion is in fluid communication with the outlet when the negative pressure difference has a first magnitude. The sampling portion includes a second flow controller configured to transition from the first state in which the sampling portion is isolated from the inlet to a second state in which the sampling portion is in fluid communication with the inlet when the negative pressure difference has a second magnitude greater than the first magnitude. [Brief explanation of the drawings]

[0008] [Figure 1] 1 is a schematic diagram of a fluid control device according to an embodiment. [Figure 2] 1 is a schematic diagram of a fluid control device according to an embodiment. [Figure 3] 1 is a schematic diagram of a fluid control device according to an embodiment. [Figure 4]1 is a schematic diagram of a fluid control device according to an embodiment. [Figure 5] 1 is a schematic diagram of a flow controller included in a fluid control device according to various embodiments. [Figure 6] 1 is a schematic diagram of a flow controller included in a fluid control device according to various embodiments. [Figure 7] 1 is a schematic diagram of a flow controller included in a fluid control device according to various embodiments. [Figure 8] 1 is a schematic diagram of a fluid control device according to an embodiment. [Figure 9] 9 is a schematic cross-sectional view of the fluid control device shown along line AA in FIG. 8 and shown in a first state. [Figure 10] 9 is a schematic cross-sectional view of the fluid control device shown along line AA in FIG. 8 and shown in a second state. [Figure 11] 1 is a schematic cross-sectional view of a fluid control device in a first state, according to an embodiment. [Figure 12] 1 is a schematic cross-sectional view of a fluid control device in a second state, according to an embodiment. [Figure 13] 1 is a schematic cross-sectional view of a fluid control device in a first state, according to an embodiment. [Figure 14] 1 is a schematic cross-sectional view of a fluid control device in a second state, according to an embodiment. [Figure 15] 10A-10C illustrate methods of diverting an initial volume of bodily fluid to obtain a reduced contamination bodily fluid sample using a fluid control device according to different embodiments. [Figure 16] 10A-10C illustrate methods of diverting an initial volume of bodily fluid to obtain a reduced contamination bodily fluid sample using a fluid control device according to different embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0009] Described herein are devices and methods for collecting, diverting, segregating, isolating, etc., an initial volume of bodily fluid to reduce contamination in subsequently procured bodily fluid samples. Any of the fluid control devices described herein can be configured to receive, source, and / or transfer a flow, bolus, volume, etc. of bodily fluid. A first reservoir, channel, flow path, chamber, and / or portion of the device can receive the initial volume of bodily fluid flow and then substantially or completely isolate it therein (e.g., contain or retain, bypass, isolate, separate, vapor-lock, separate, and / or the like). In some examples, contaminants, such as microorganisms present on the skin, are contained in and / or entrained in the initial volume of bodily fluid and similarly are isolated in or by the first reservoir, flow path, or portion of the device. Once the initial volume is isolated, any subsequent volume of bodily fluid flow can be diverted, deflected, directed, and / or otherwise permitted to flow to or through a second portion of the device and / or any additional flow path(s) thereof. Based at least in part on the initial volume that is sequestered, the subsequent volume(s) of bodily fluid may be substantially free of contaminants that may otherwise cause inaccurate, skewed, adulterated, and / or false results in some diagnostic and / or testing. In some examples, the initial volume of bodily fluid may also be used in other tests, e.g., those that are less affected by the presence of contaminants, discarded as a waste volume, infused back into the patient, and / or used in other appropriate clinical applications.

[0010] 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 challenges that can limit and / or prevent a sufficient pressure differential to fully engage the isolation chamber or isolation portion of the control device and / or to shift fluid flow into the fluid collection device, (2) result in the isolation chamber being properly filled with a clinically validated and / or desired volume of bodily fluid, (3) result in an efficient, timely, and / or user-accepted bodily fluid collection process consistent with the process, and / or (4) provide a means to shift fluid flow (e.g., automatically or by manipulating any number of physical components of the system to move, or by changing, switching, engaging, and / or otherwise providing desired fluid flow dynamics) to enable the isolation and / or separation of an initial volume (e.g., a pre-sample) and the collection of a subsequent sample.

[0011] In some embodiments, the fluid control device includes an inlet and an outlet. The inlet is configured to be placed in fluid communication with a bodily fluid source, and the outlet is configured to be placed in fluid communication with a fluid collection device. Coupling the outlet to the fluid collection device can create a negative pressure difference within the fluid control device between the outlet and the inlet. The fluid control device has an isolation portion in fluid communication with the inlet and a sampling portion in fluid communication with the outlet. The isolation portion includes a first flow controller configured to transition from a first state in which the isolation portion is isolated from the outlet to a second state in which the isolation portion is in fluid communication with the outlet when the negative pressure difference has a first magnitude. The sampling portion includes a second flow controller configured to transition from the first state in which the sampling portion is isolated from the inlet to a second state in which the sampling portion is in fluid communication with the inlet when the negative pressure difference has a second magnitude greater than the first magnitude.

[0012] In some embodiments, the fluid control device includes a housing, a first flow controller, and a second flow controller. The housing has an inlet configured to establish fluid communication with a bodily fluid source and an outlet configured to be coupled to a fluid collection device. The housing defines an isolation flow path in fluid communication with the inlet and a sampling flow path in fluid communication with the outlet. The first flow controller has a flow state in which the isolation flow path is in fluid communication with the outlet and a non-flow state in which the isolation flow path is isolated from the outlet. The second flow controller has a flow state in which the sampling flow path is in fluid communication with the inlet and a non-flow state in which the sampling flow path is isolated from the inlet. The first flow controller is configured to be in the flow state when a negative pressure differential created by coupling the outlet to the fluid collection device has a first magnitude such that an initial volume of bodily fluid flows through the isolation flow path toward the first flow controller. The first flow controller is configured to transition to a no-flow state when an initial volume of bodily fluid is received in the isolated flow path such that (1) the isolated flow path is isolated from the outlet and (2) the negative pressure differential is increased to a second magnitude operable to transition the second flow controller from the no-flow state to a flow state.

[0013] In some embodiments, a method for obtaining a reduced-contamination bodily fluid sample using a fluid control device includes coupling a fluid collection device to an outlet of the fluid control device. The coupling of the fluid collection device to the outlet is configured to create a negative pressure differential within at least a portion of the fluid control device. The first flow controller is transitioned from a first state to a second state when the negative pressure differential has a first magnitude. The first flow controller is configured to isolate an isolation portion of the fluid control device from the outlet when in the first state and to establish fluid communication between the isolation portion and the outlet when in the second state. When the first flow controller is in the second state, an initial volume of bodily fluid is received from the inlet of the fluid control device into the isolation portion in response to the negative pressure differential. The first flow controller is configured to transition from the second state to a third state in response to the isolation portion receiving the initial volume of bodily fluid. When the first flow controller is in the third state, the first flow controller isolates the isolation portion from the outlet and the negative pressure differential increases from the first magnitude to the second magnitude. The second flow controller is transitioned from the first state to the second state when the negative pressure differential has a second magnitude. The second flow controller is configured to isolate the sampling portion of the fluid control device from the inlet when in the first state and to establish fluid communication between the sampling portion and the inlet when in the second state. A subsequent volume of bodily fluid is transferred from the inlet to the fluid collection device through the sampling portion and the outlet.

[0014] In some embodiments, the fluid control device includes an inlet and an outlet. The inlet is configured to be placed in fluid communication with a bodily fluid source or an intermediate bodily fluid transfer device. The outlet is configured to be placed in fluid communication with a fluid collection device, such as, for example, a sample reservoir (e.g., a bottle, container, dish, vial, etc.), a culture bottle, and a vacuum container, a liquid collection device, a syringe, a lumen-containing device, and / or any other suitable bodily fluid collection and / or transfer device. The fluid control device has a first state in which a negative pressure differential generated from an external source (e.g., a sample reservoir, a syringe, a container, and / or any suitable intermediate fluid reservoir) is applied to the fluid control device to draw an initial volume of bodily fluid from the bodily fluid source through the inlet and into an isolation and / or diversion portion of the fluid control device (which may be formed by, within, or coupled to the fluid control device). The fluid control device has a second state in which (1) the isolating and / or diverting portion isolates an initial volume and (2) a negative pressure differential draws a subsequent volume of bodily fluid that is substantially free of contaminants from the bodily fluid source, through the fluid control device, and into the fluid collection device.

[0015] Any of the embodiments and / or methods described herein can be used to obtain a clean or substantially pure bodily fluid sample, such as, for example, a blood sample. In some examples, the bodily fluid sample (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), and / or other undesirable microorganisms. During diagnostic testing, various techniques can be employed to assist in detecting the presence of microorganisms, as well as other types of biological material, specific types of cells, biomarkers, proteins, antigens, enzymes, blood components, and / or the like. Examples include, but are not limited to, molecular polymerase chain reaction (PCR), magnetic resonance and other magnetic analysis platforms, automated microscopy, spatial clone isolation, flow cytometry, whole blood ("culture-free") specimen analysis (e.g., NGS) and related techniques, morphokinetic cell analysis, and / or other common or emerging and advanced techniques for characterizing patient specimens and / or for detecting, identifying, typing, classifying, and / or characterizing specific organisms, antibiotic susceptibility, and / or the like.

[0016] For example, in some instances, microbiological testing and / or detection can involve culturing a blood sample in one or more containers, which may contain media (e.g., nutrient-rich media and / or environmentally controlled media to promote growth, and / or any number of other media), general additives, and / or other types of solutions conducive to microbial growth. Any microorganisms and / or organisms present in the blood sample thrive and / or grow in the media over time (e.g., for a variable period of time, from less than an hour to several days or more—this may be longer or shorter, depending on the diagnostic technique employed). The presence of microorganisms and / or organisms can be detected by automated, continuous monitoring, and / or other methods specific to the analytical platform and / or technique used for detection, identification, and / or the like (e.g., by observation of carbon dioxide levels and / or any other appropriate detection method).

[0017] The presence of microorganisms and / or organisms in the culture medium suggests the presence of the same microorganisms and / or organisms in the blood sample, which in turn suggests the presence of the same microorganisms and / or organisms in the bodily fluid of the patient from which the sample was obtained. In other examples, the bodily fluid sample may be analyzed ordered (i.e., not cultured) for the presence of microorganisms and / or organisms. Thus, if microorganisms and / or organisms are determined to be present in the blood sample, the patient may 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.

[0018] However, patient samples can become contaminated during procurement and / or suffer false-negative results. For example, microorganisms from body surfaces (e.g., microorganisms present on the skin) that are removed during the specimen procurement process (e.g., directly or indirectly via tissue debris, hair follicles, sweat glands, and other skin appendage structures) may subsequently be transferred with the patient specimen to a culture medium, test vial, or other appropriate specimen collection or transfer container, and / or may otherwise be included in the specimen to be analyzed. Another potential source of contamination is from the person drawing the patient sample (e.g., a physician, phlebotomist, nurse, technician, etc.) and / or the equipment used to draw the patient sample. For example, the equipment, supplies, and / or devices used during the patient sample procurement 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 / tubing-to-sample container, and / or any other fluid interface, or any combination thereof), each of which can introduce potential contamination points. In some instances, such contaminants may grow in the culture medium and / or may otherwise be identified, thereby increasing the risk or likelihood of false, compromised, and / or erroneous microbiological test results that may inaccurately reflect the presence or absence of such microorganisms within the patient (i.e., in vivo).

[0019] Such inaccurate results due to contamination and / or other sources of adulteration are of concern 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 can result in a misdiagnosis of a patient's illness and / or delayed treatment (which may result in patient harm and / or death), or, alternatively, result in the patient unnecessarily receiving one or more antimicrobial therapies, which may cause serious adverse patient reactions and / or consequences, including, for example, death. Thus, erroneous results create unnecessary burdens and costs for the healthcare system due to extended patient length of stay and / or other complications associated with incorrect treatment. Using imaging devices that result in such erroneous results is of concern both from a cost perspective and a patient safety perspective, as unnecessary exposure to concentrated radiation associated with various imaging modalities (e.g., CT scans) has many known adverse effects on long-term patient health.

[0020] 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 "element" is intended to mean a single element or a combination of elements, and "material" is intended to mean one or more materials or combinations thereof.

[0021] As used herein, when used in connection with a described value and / or geometric configuration or relationship, the terms "about," "approximately," and / or "substantially" are intended to convey that the value or characteristic so defined is the nominally described value and / or described characteristic. In some examples, the terms "about," "approximately," and / or "substantially" generally mean and / or can assume the described value or characteristic within a desired tolerance range (e.g., plus or minus 10% of the described value or characteristic). 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. While described values, structures, and / or relationships may be desirable, it should be understood that some variation may occur, for example, as a result of manufacturing tolerances or other practical considerations (e.g., pressure or force applied 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.

[0022] As used herein, "body fluid" can include any fluid obtained directly or indirectly from a patient's body. For example, "body fluid" includes, but is not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, sputum, vitreous humor, air, and the like, or any combination thereof.

[0023] As used herein, the terms "proximal" and "distal" refer to directions toward and away from, respectively, a user who positions the device in contact with a patient. Thus, for example, the end of the device that first touches the patient's body is the distal end, and the opposite end of the device (e.g., the end of the device that is manipulated by the user) is the proximal end of the device.

[0024] 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. A "pre-sample," "first," and / or "initial" volume can refer to a predetermined, defined, desired, and / or given volume of bodily fluid. For example, a predetermined and / or desired pre-sample volume of bodily fluid can be a drop of bodily fluid, several drops of bodily fluid, and / or a volume of bodily fluid equal to 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 fraction therebetween. Alternatively, the pre-sample volume may be greater than 50.0 mL or less than 0.1 mL. In some particular embodiments, the predetermined and / or desired pre-sample volume may be from about 0.1 mL to about 5.0 mL. In other embodiments, the pre-sample volume may be, for example, the total volume of any number of lumens (e.g., lumens forming at least a portion of the flow path from the bodily fluid source to the initial collection chamber, section, reservoir, etc.).

[0025] As used herein, the terms "sample," "second," and / or "subsequent" can be used interchangeably to describe, for example, a volume, portion, or amount of bodily fluid used in one or more samples or diagnostic tests. A "sample" volume may be a random volume of bodily fluid collected after collecting, segregating, and / or isolating a pre-sample volume of bodily fluid, or a predetermined or desired volume. A desired sample volume of bodily fluid may be, for example, between about 10.0 mL and about 60.0 mL. Alternatively, a desired sample volume of bodily fluid may be less than 10.0 mL or greater than 60.0 mL. In some embodiments, for example, the sample volume may be based, at least in part, on one or more tests, evaluations, analyses, and / or processes to be performed on the sample volume.

[0026] The embodiments described herein can be configured to transfer reduced-contamination and / or substantially uncontaminated bodily fluids to one or more fluid collection device(s). In some embodiments, the fluid collection device can include, but is not limited to, any suitable vessel, container, reservoir, bottle, adapter, dish, vial, syringe, device, diagnostic and / or testing machine, and / or the like. In some embodiments, the fluid collection device can be substantially similar to or the same as known sample containers, such as, for example, Vacutainer® (manufactured by Becton Dickinson and Company (BD)), BacT / ALERT® SN, or BacT / ALERT® FA (manufactured by Biomerieux, Inc.), and / or any suitable reservoir, vial, microvial, microliter vial, nanoliter vial, container, microcontainer, nanocontainer, and / or the like. In some embodiments, the fluid collection device may be similar and / or substantially the same as any of those 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 herein by reference in its entirety.

[0027] In some embodiments, the bodily fluid collection device may be empty prior to receiving a sample volume of bodily fluid. For example, in some embodiments, the fluid collection device or reservoir may be configured to define or generate a vacuum or suction, such as, for example, a vacuum-based collection tube (e.g., Vacutaner®), a syringe, and / or the like. In some embodiments, the sample reservoir may contain, for example, any suitable additive, substance, enzyme, oil, fluid, compound, chemical, etc. (e.g., heparin, citrate, acid citrate dextrose (ACD), ethylenediaminetetraacetic acid (EDTA), oxalate, sodium polyanethol sulfonate (SPS), and / or the like). In other embodiments, the sample reservoir may contain, for example, an aerobic medium or an anaerobic medium. A sample reservoir (e.g., a culture bottle) can receive a bodily fluid sample, which can then be tested (e.g., after culturing using 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 organism. If the medium tests positive, the medium can then be tested to identify the specific organism, for example, using a PCR-based system.

[0028] The term "media" can be used to describe a substance configured to react with organic matter in a bodily fluid (e.g., microorganisms such as bacteria), and the term "additive" can be used to describe a substance configured to react with a portion of a bodily fluid (e.g., constituent cells of blood, serum, synovial fluid, etc.), and 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 media, an additive, and / or any other suitable substance, and / or any combination thereof. That is, the embodiments described herein can be used with any suitable fluid collection device, reservoir, and / or the like containing any suitable substance.

[0029] Although some of the embodiments are described herein as being used to procure 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 disposed in fluid communication therewith. Thus, while specific examples are described herein, the devices, methods, and / or concepts are not intended to be limited to such specific examples.

[0030] The embodiments and / or portions thereof described herein can be formed or constructed of one or more biocompatible materials. In some embodiments, the biocompatible material can be selected based on one or more properties of the constituent material, such as, for example, stiffness, toughness, durometer, bioreactivity, 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 can 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, polyester, polycarbonate, polyacrylate, polysiloxane (silicone), 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] 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 component may be formed by a single part having any number of sections, regions, portions, and / or features, or may be formed by multiple parts or features. For example, when referring to a structure such as a wall or chamber, the structure may be considered a single structure having multiple parts, or multiple separate substructures or the like joined to form the structure. Thus, a monolithically constructed structure may include, for example, a set of substructures. Such a set of substructures may include multiple parts that are either contiguous or discontinuous with one another. A set of substructures may also be made from multiple items or components that are manufactured separately and later joined (e.g., via welding, adhesives, snaps, and / or any suitable method).

[0032] Referring now to the drawings, FIG. 1 is a schematic diagram of a fluid control device 100 according to an embodiment. Generally, the fluid control device 100 (also referred to herein as a "control device" or "device") is configured to withdraw bodily fluid from a patient. A first portion or amount (e.g., an initial amount) of the withdrawn bodily fluid is isolated from a second portion or amount (e.g., a subsequent amount) of the withdrawn bodily fluid, which can then be used for additional testing, discarded, and / or reinfused into the patient. In this manner, contaminants or the like can 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 can then be used as a biological sample in one or more tests for medical diagnostic and / or therapeutic purposes (e.g., blood culture tests or the like), as described in more detail herein. The first portion or amount of bodily fluid can be discarded as waste or used in any appropriate test unlikely to produce erroneous, inaccurate, distorted, inconsistent, or unreliable results as a result of potential contaminants contained therein. In some situations, for example, in a patient with a limited supply of bodily fluid, such as blood, a first portion or amount of the bodily fluid can be reinfused into the patient via any suitable method.

[0033] Control device 100 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, control device 100 can have a size based at least in part on the volume of bodily fluid to be at least temporarily stored, e.g., in the sequestration, diversion, isolation, and / or storage portion of control device 100. As described in further detail herein, control device 100 may be configured to transition between operational modes such that (1) a first portion or quantity of bodily fluid selectively flows through at least a first portion of the fluid control device and is thereafter sequestered therein, and (2) a second portion or quantity of bodily fluid selectively flows through at least a second portion of the fluid control device, into a fluid collection device, or the like. In some embodiments, control device 100 may be configured to transition between operational modes automatically (e.g., based on a pressure differential, time, an electronic signal or command, saturation of a membrane or member, an absorbent and / or barrier material, etc.) or via and / or in response to intervention (e.g., user intervention, mechanical intervention, etc.).

[0034] The control device 100 includes an inlet 112, at least one outlet 116, and an isolation chamber 114. Additionally, the control device 100 defines one or more fluid flow paths 113 between the inlet 112 and at least one isolation chamber 114, and / or one or more fluid flow paths 154 between the inlet 112 and the outlet 116.

[0035] The inlet 112 of the control device 100 is configured to be placed in fluid communication with a source of bodily fluid, such as, for example, the patient's vasculature. In some embodiments, the inlet 112 can be coupled to and / or include an inlet device, such as, for example, an intravenous (IV) catheter, a needle, a peripherally inserted central catheter (PICC), a syringe, one or more sterile tubing, and / or any other suitable lumen-containing device and / or intermediate transition device. In some embodiments, the inlet 112 can be a port, a valve, and / or a coupler, such as, for example, a Luer Lok® or any other suitable coupler. In such embodiments, the inlet 112 (e.g., a port or coupler) can be configured to couple to an access or inlet device that is in fluid communication with the patient (e.g., a placed or indwelling IV catheter or needle). In some embodiments, the inlet 112 can be physically and fluidly coupled to the access or inlet device using a lock, coupler, port, or the like. In other embodiments, the inlet 112 can be in fluid communication with the access or inlet device via an intermediate lumen-containing device, such as, for example, a sterile tubing. In still other embodiments, the inlet 112 of the control device 100 may form and / or be integrally or monolithically formed with the access or inlet device.

[0036] Isolation chamber 114 is at least temporarily disposed in fluid communication with inlet 112 via fluid flow path 113. As described in further detail herein, isolation chamber 114 is configured to (1) receive a flow and / or volume of bodily fluid from inlet 112 and (2) isolate (e.g., separate, fractionate, contain, hold, isolate, etc.) the flow and / or volume of bodily fluid therein.

[0037] 1 , in some embodiments, the fluid control device 100 can have one or more flow channels 113(s) that include one or more flow regulation features (e.g., flow restrictors, fluid flow suppressors, etc.) that selectively regulate the flow of bodily fluid drawn therethrough. In some embodiments, the flow regulation features can be structural and incorporated into the fluid control device 100. In other embodiments, the flow regulation features can be formed separately or can be materials that can be introduced into the fluid control device 100, for example, into the isolation chamber 114, as described in further detail herein.

[0038] Control chamber 114 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, isolation chamber 114 may be at least partially formed by a body portion of control device 100 (not shown in FIG. 1 ). In other embodiments, isolation chamber 114 may be a reservoir located and / or arranged within a portion of control device 100. In other embodiments, isolation chamber 114 may be formed and / or defined by a portion of fluid flow path 113. That is, control device 100 may define one or more lumens and / or include one or more lumen-defining device(s) configured to receive a flow of bodily fluid from inlet 112, thereby defining fluid flow path 113. In such embodiments, at least a portion of the lumen and / or a portion of the lumen-defining device(s) may form and / or define isolation chamber 114.

[0039] The isolation chamber 114 can have any suitable volume and / or fluid capacity. For example, in some embodiments, the isolation chamber 114 can have a volume and / or fluid capacity of about 0.25 mL to about 5.0 mL. In some embodiments, the isolation chamber 114 can have a volume measured in sub-microliter volumes of bodily fluid (e.g., 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 114 can have a volume of, for example, up to about 5.0 mL, 10.0 mL, 15.0 mL, 20.0 mL, 30.0 mL, 40.0 mL, 50.0 mL, or more. In some embodiments, the isolation chamber 114 can have a volume equal to and / or based at least in part on the lumen of an inlet device coupled to and / or included in the control device 100, the lumen of the inlet 112, and a portion of the fluid flow path 113 defined between the inlet 112 and the isolation chamber 114, and / or any combination thereof. In other embodiments, the isolation chamber 114 can have a volume equal to and / or based at least in part on the individual and / or combined volumes of the portion of the inlet device, the inlet 112 of the control device 100, and a portion of the fluid flow path 113 defined between the inlet 112 and the isolation chamber 114.

[0040] 1 , in some embodiments, fluid control device 100 and / or isolation chamber 114 can include and / or be formed of one or more features or materials configured to interact with a portion of bodily fluid transferred within isolation chamber 114. For example, in some embodiments, fluid control device 100 and / or isolation chamber 114 can include and / or define a valve, membrane, diaphragm, restrictor, vent, selectively permeable member (e.g., a fluid-impermeable barrier or seal that at least selectively allows air or gas to pass therethrough), port, junction, actuator, and / or the like, or any suitable combination thereof (collectively referred to herein as a “flow controller”). Such flow controllers can be configured to selectively control (at least in part) the flow of fluid into or out of isolation chamber 114 and / or any other suitable portion of fluid control device 100. In this regard, the fluid flow may be a liquid, such as, for example, water, oil, dampening fluid, body fluid, and / or any other suitable liquid, and / or may be a gas, such as air, oxygen, carbon dioxide, helium, nitrogen, ethylene oxide, and / or any other suitable gas.

[0041] In some embodiments, the one or more openings and / or one or more flow controllers can be configured to facilitate the displacement of air into and out of the isolation chamber 114. In some embodiments, the displacement of air from the isolation chamber 114 as an initial portion of bodily fluid is transferred into the isolation chamber 114 allows for a redistribution of pressure within the isolation chamber 114 and / or between the isolation chamber 114 and, for example, a fluid source and / or a portion of the fluid flow path outside the isolation chamber 114, or the pressure of the surrounding environment through which the isolation chamber 114 is vented. In some embodiments, the redistribution of pressure can be a factor in determining and / or defining how bodily fluid flows through the control device 100 and / or the amount or volume of bodily fluid transferred into the isolation chamber 114.

[0042] In other embodiments, the isolation chamber 114 and / or the control device 100 may include a flow controller operable to selectively control the flow of bodily fluid through the fluid flow path 113 in any suitable manner. For example, in some embodiments, the control device 100 may be configured to selectively transfer a volume of bodily fluid to the isolation chamber 114 or to the outlet 116 based at least in part on a pressure differential between two or more portions of the control device 100. In some embodiments, the pressure differential may result from fluidly coupling the outlet 116 to a vacuumed fluid collection device 160 (e.g., a sample reservoir, a syringe, a pressure charge canister, and / or other source or potential energy for generating a vacuum or pressure differential). In other embodiments, the pressure differential may result from a change in volume and / or temperature. In still other embodiments, the pressure differential may result from at least a portion of the control device 100 and / or other portions of the flow paths 113 and / or 154 being evacuated and / or filled (e.g., the isolation chamber 114 and / or any other suitable portion). In some embodiments, the pressure differential can be established automatically or through direct or indirect intervention and / or manipulation (e.g., by a user). Additionally, the flow of fluid (e.g., gas and / or liquid) resulting from the pressure differential can be selectively controlled, for example, via one or more flow controllers that can transition between one or more operating conditions to control the flow of fluid. It should be understood that the flow controllers included in the embodiments described herein are presented by way of example and not limitation. Thus, while specific flow controllers are described herein, it should be understood that the flow of fluid can be controlled through control device 100 by any suitable means.

[0043] In some embodiments, the walls or structures of the fluid control device 100 can define openings, apertures, ports, orifices, etc. that are in fluid communication with the isolation chamber 114. In some embodiments, the control device 100 can include a semi-permeable member, membrane, or material, such as a hydrophobic or hydrophilic membrane, disposed in or around an opening in the fluid flow path 113, or elsewhere, to selectively allow the flow of air or gas through the opening, while restricting or substantially preventing the flow of fluid (e.g., a bodily fluid such as blood) through the opening.

[0044] In some embodiments, for example, control device 100 can include an absorbent and / or hydrophilic material disposed within isolation chamber 114. Thus, when bodily fluid is transferred into isolation chamber 114, the absorbent and / or hydrophilic material can absorb, attract, retain, swell, and / or otherwise interact with at least a portion of the bodily fluid, as described in further detail herein, and thus can sequester and / or retain at least an initial portion of the bodily fluid within isolation chamber 114.

[0045] In some embodiments, the fluid control device 100 can include one or more self-sealing venting materials that allow the flow of air or air pressure (e.g., vacuum) but not fluid (e.g., liquid) through them. For example, the self-sealing material, when wetted or in contact with a fluid, can absorb or otherwise become saturated and transition to a sealing configuration in which the self-sealing material does not allow air or liquid to pass through. The transition of the self-sealing material (e.g., vent) can be associated with the fluid control device 100 moving from a first state (e.g., a state in which an initial portion of the bodily fluid is being transferred into the isolation chamber 114) to a second state (e.g., after the initial portion of the bodily fluid has been transferred into the isolation chamber 114).

[0046] In some embodiments, the isolation chamber 114 or any other portion of the fluid control device 100 can include and / or be formed of an expandable or collapsible material configured to transition from a first state (e.g., while the initial portion of the bodily fluid is being transferred to the isolation chamber 114) to a second state (e.g., after the initial portion of the bodily fluid has been transferred to the isolation chamber 114). For example, the collapsible material can initially be in the form of a dissolvable substance that blocks the flow path 113 in which it resides and does not allow the flow of fluid (e.g., gas or liquid). However, upon contact with a predetermined amount of fluid, the material can dissolve or otherwise transition to a dissolved configuration to unblock the fluid flow path 113 in which it is located. In some embodiments, the change in configuration resulting from such material expanding, collapsing, dissolving, etc. can be operable to transition the control device 100 and / or any appropriate portion of the control device 100 from a first state, mode, position, configuration, etc. to a second state, mode, position, configuration, etc., as described in further detail herein.

[0047] In some embodiments, the control device 100 and / or isolation chamber 114 can include valves, such as, for example, duckbill valves, butterfly valves, one-way check valves, etc., and can be made from any suitable material with any suitable cracking pressure (e.g., the amount of pressure or force sufficient to open the valve) used to direct fluid flow as needed. For example, the fluid control device 100 can include two or more valves with varying cracking pressures that sequentially open with increasing pressure. Such a configuration can be used, for example, in combination with a suitable negative pressure source and a suitable flow controller to direct fluid flow.

[0048] The outlet(s) 116 are in fluid communication and / or are configured to be placed in fluid communication with the fluid flow paths 113 and / or 154. The outlet 116 may be any suitable outlet, opening, port, stopcock, lock, seal, coupler, valve (e.g., one-way check valve, duckbill valve, umbrella valve, and / or the like), etc., and is configured to be fluidly coupled to the fluid collection device 160. In some embodiments, the outlet 116 may be monolithically formed with the fluid collection device 160, syringe, and / or other intermediate bodily fluid transfer device. In other embodiments, the outlet 116 may be at least temporarily coupled to the collection device 160 via adhesive, a resistance fit, a mechanical fastener, a threaded connection, a drilled or punctured arrangement, any number of mating recesses, and / or other suitable connection or combination thereof. Similarly stated, the outlet 116 may be physically (e.g., mechanically) and / or fluidly coupled to the collection device 160 such that the interior volume defined by the collection device 160 is in fluid communication with the outlet 116. In yet other embodiments, the outlet 116 may be operably coupled to the collection device 160 via an intervening structure (not shown in FIG. 1 ), such as a flexible sterile tubing. In still other embodiments, the outlet 116 may be fluidly coupled to a downstream negative pressure source that appropriately directs fluid flow into the collection device 160.

[0049] In some embodiments, the arrangement of the outlet 116 may be such that the outlet 116 is physically and / or fluidically sealed prior to coupling to the collection device 160. In some embodiments, the outlet 116 may transition from a sealed configuration to a non-sealed configuration in response to being coupled to the collection device 160 and / or in response to a negative pressure differential between the environment within the outlet 116 and / or the control device 100 and the environment within the collection device 160.

[0050] Fluid collection device 160 may be any suitable apparatus for at least temporarily containing bodily fluid, such as, for example, those described above. For example, in some embodiments, fluid collection device 160 may be a single-use disposable collection tube, a syringe, a vacuum-based collection tube, an intermediate bodily fluid transfer device, and / or the like. In some embodiments, fluid collection device 160 may be substantially similar to or the same as known sample containers, such as, for example, a Vacutainer®, BacT / ALERT® SN, or BacT / ALERT® FA, and / or any other suitable reservoir, vial, microvial, microliter vial, nanoliter vial, container, microcontainer, nanocontainer, and / or the like. In some embodiments, collection device 160 may be a sample reservoir including a vacuum seal that maintains a negative pressure (vacuum) within the sample reservoir, as described in further detail herein, which in turn can facilitate drawing bodily fluid from the patient into the sample reservoir through fluid control device 100 using a vacuum or suction force. In embodiments in which the fluid collection device 160 is a vacuum container or the like, a user can couple the collection device 160 to the outlet 116 to initiate the flow of bodily fluid from the patient, whereby a first or initial portion of the bodily fluid is transferred into and thereby isolated by the isolation chamber 114, and any subsequent portions or volumes of the bodily fluid bypass and / or otherwise divert from the isolation chamber 114 and flow into the fluid collection device 160.

[0051] Although outlet 116 of control device 100 is described above as being fluidly coupled to and / or otherwise in fluid communication with a fluid collection device 160 (e.g., a sample reservoir, syringe, etc.), in other embodiments, control device 100 can be used in combination with any suitable bodily fluid collection device, system, and / or the like. For example, in some embodiments, fluid control device 100 can be used with any suitable fluid transfer device, such as those described in U.S. Patent Publication No. 2015 / 0342510, entitled "Sterile Bodily-Fluid Collection Device and Methods," filed June 2, 2015 (referred to herein as the "'510 Publication"), the disclosure of which is incorporated herein by reference in its entirety. More specifically, control device 100 can be used in "one-piece" or pre-assembled devices (e.g., such as those described in the '510 Publication) to receive and isolate an initial volume of bodily fluid to reduce and / or eliminate contaminants in subsequent volumes of bodily fluid. In other embodiments, outlet 116 may include and / or be coupled to an adapter, outlet needle, and / or the like. For example, in some embodiments, outlet 116 may be coupled to and / or include a transfer adapter and / or the like, such as, for example, the transfer adapter described in U.S. Patent Publication No. 2015 / 0246352, entitled "Apparatus and Methods for Disinfection of a Specimen Container," filed March 3, 2015 (hereinafter "the '352 Publication"), the disclosure of which is incorporated herein by reference in its entirety.

[0052] As described above, device 100 can be used to obtain a bodily fluid sample with reduced contamination from microorganisms, such as, for example, microorganisms present on the skin, and / or the like. For example, in some instances, a user, such as a doctor, physician, nurse, phlebotomist, technician, etc., can operate device 100 to establish fluid communication between inlet 112 and a bodily fluid source (e.g., a patient's vein, cerebrospinal fluid (CSF) from the spinal cavity, a urine sample, and / or the like). As a particular example, in some instances, inlet 112 can be coupled to and / or include a needle or the like operable to pierce the patient's skin and insert at least a portion of the needle into the patient's vein, thereby placing inlet 112 in fluid communication with the bodily fluid source (e.g., a vein, an IV catheter, a PICC, etc.).

[0053] In some embodiments, when the inlet 112 is placed in fluid communication with a bodily fluid source (e.g., a portion of a patient), the outlet 116 can be fluidly coupled to a collection device 160. As described above, the collection device 160 can be any suitable reservoir, container, and / or collection system configured to receive a volume of bodily fluid. More specifically, the collection device 160 can be, for example, a vacuum reservoir or container that defines a negative pressure and / or a syringe that can be operated to generate a negative pressure. In some examples, coupling the outlet 116 to the collection device 160 selectively exposes at least a portion of the fluid flow paths 113 and / or 154 to a negative pressure, thereby creating a negative pressure differential operable to draw bodily fluid from the bodily fluid source (e.g., a patient), through the inlet 112, and into the fluid control device 100.

[0054] In some embodiments, control device 100 is positioned so that when a volume of bodily fluid is transferred to and / or through inlet 112, an initial portion of the volume of bodily fluid (also referred to herein as an "initial volume" or "first volume") flows from inlet 112, through at least a portion of fluid flow path 113, and into isolation chamber 114. That is, in some embodiments, control device 100 can be placed in a first or initial state to allow an initial portion or volume of bodily fluid to flow into or through at least a portion of fluid flow path 113 and into isolation chamber 114. For example, in some embodiments, the initial state of control device 100 can be a state in which one or more flow controllers (e.g., valves, membranes, diaphragms, restrictors, vents, air-permeable and fluid-impermeable barriers, ports, and / or the like) are in a first state in which fluid flow path 113 is exposed to a negative pressure differential through isolation chamber 114. In other words, negative pressure within the sample reservoir 160 (or generated by a syringe or other negative pressure source) can create a negative pressure (or negative pressure differential) within at least a portion of the isolation chamber 114 that is operable to draw an initial flow of bodily fluid into the isolation chamber 114 when one or more flow controllers are in a first or initial state.

[0055] For example, in some embodiments, the control device 100 can include one or more flow controller(s), as described above, at least temporarily fluidly coupled to the flow path between the fluid collection device 160 and the isolation chamber 114. In some embodiments, the flow controller(s) can be at least temporarily fluidly coupled to the flow path between the fluid collection device 160 and the inlet 112. In some embodiments, the examples of flow controllers described above can be known, commercially available components used in medical devices, for example, to control fluid and air flow, while in other embodiments, the flow controller can be a custom, proprietary, and / or specially tailored component integrated into the device 100. When the flow controller is in a first or initial state, the flow controller can allow fluid flow therethrough in response to a negative pressure on the collection device 160. In some embodiments, the flow controller is configured to allow only air or gas flow through the flow controller and to restrict and / or substantially prevent the flow of liquid (e.g., bodily fluid) through the flow controller. In this manner, the collection device 160 can generate a negative pressure differential operable to draw an initial portion and / or volume of bodily fluid into the isolation chamber 114 without allowing the initial portion of the bodily fluid to flow into the fluid flow path 154 and / or flow out of the isolation chamber 114 when the flow controller is in a first or initial state.

[0056] Although not shown in FIG. 1 , in some embodiments, the control device 100 can include a member, device, mechanism, feature, etc. configured to regulate the amount of negative pressure to which the isolation chamber 114 is exposed. For example, in some embodiments, the control device 100 can include a valve, a membrane, a porous material, a restrictor, and / or any other suitable member and / or device configured to regulate pressure. In some embodiments, regulating and / or controlling the amount of pressure to which the isolation chamber 114 can be exposed can, in turn, regulate the amount of pressure imparted to the bodily fluid and / or within the patient's veins. In some examples, such pressure regulation can, for example, reduce the likelihood of hemolysis of a blood sample and / or collapsing a vein (e.g., this is particularly important in vulnerable patients requiring microbiological and / or other diagnostic tests associated with use of the control device 100). Additionally, regulating the negative pressure can, for example, at least partially control the rate at which the control device 100 transitions between a first configuration or state and a second configuration or state. In some embodiments, regulating the negative pressure can function like a timer. For example, the time between the introduction of the negative pressure differential and the transition of the diverter from the first state to the second state may be known, predetermined, calculated, and / or controlled. Thus, in some examples, adjusting the negative pressure may, at least in part, control the amount or volume of bodily fluid transferred into the isolation chamber 114 (e.g., control the volume of the initial amount of bodily fluid).

[0057] The initial portion and / or amount of bodily fluid can be any suitable volume of bodily fluid, as described above. For example, in some instances, control device 100 can remain in the first state until a predetermined and / or desired volume of bodily fluid (e.g., the initial volume) has been transferred to isolation chamber 134. In some embodiments, the initial volume can be related to and / or based at least in part on the volume of isolation chamber 114. The initial amount can be related to and / or based at least in part on the amount or volume of bodily fluid that can be transferred into control device 100 before one or more portions of the device transition from a first operating state or mode to a second operating state or higher (e.g., an amount of bodily fluid that can be absorbed by an absorbent, swellable, hydrophilic, and / or wettable material; an amount of bodily fluid sufficient to fully wet or saturate a vent material or semi-permeable member or membrane; an amount sufficient to equalize one or more pressure differentials within control device 100; an amount sufficient to shift a valve or actuator; and / or the like).

[0058] After the initial volume of bodily fluid is transferred and / or diverted to the isolation chamber 114, the initial volume is sequestered, separated, held, contained, isolated, etc. within the isolation chamber 114. For example, in some embodiments, a transition of one or more flow controllers from a first state to a second state may be operable to sequester and / or retain an initial portion of the bodily fluid within the isolation chamber 114. As described in further detail herein, in some instances, contaminants such as, for example, microorganisms present on skin removed during a venipuncture event, other external sources of contamination, colonization of catheters and PICC lines used to collect the sample, and / or the like, are entrained in and / or contained within the initial volume of bodily fluid and, therefore, are isolated therein when the initial volume is sequestered within the isolation chamber 114.

[0059] Once the initial volume has been transferred and / or diverted into the isolation chamber 114, the device 100 can transition to a second state in which subsequent volume(s) of bodily fluid can flow through the fluid flow paths 113 and / or 154 from the inlet 112 to the outlet 116. In some embodiments, the control device 100 can transition from the first state to the second state passively and / or automatically (e.g., without user intervention) once the initial volume of bodily fluid has been sequestered in the isolation chamber 114. For example, in some embodiments, filling the isolation chamber 114 to capacity and / or completely saturating, wetting, and / or impregnating with an absorbent or similar material disposed between the isolation chamber 114 and the sample reservoir 160 allows further movement of bodily fluid into the isolation chamber 114 to be limited and / or substantially prevented due to removal or diversion of negative pressure. In other embodiments, the control device 100 can transition manually or in response to at least indirect interaction by a user. For example, in some embodiments, a user can at least partially block an opening and / or a vent. In other embodiments, a user can actuate an actuator or the like (not shown in FIG. 1 ) to transition control device 100 from a first state to a second state. In still other embodiments, at least a portion of the initial volume of bodily fluid can transition control device 100 from the first state to the second state. For example, control device 100 can include a bodily fluid-activated switch, valve, port, and / or the like. In other embodiments, a volume of bodily fluid can move and / or displace one or more actuators or the like that can open, for example, ports, flow channels, and / or outlets. In still other embodiments, a user can operate such switches, valves, ports, actuators, etc. to transition control device 100 from the first state to the second state.

[0060] When collection device 160 is fluidly coupled to outlet 116 and control device 100 is in the second state (e.g., an initial volume of bodily fluid is isolated in or by isolation chamber 134), any subsequent volume(s) of bodily fluid can flow from inlet 112, through at least one of fluid flow paths 113 and / or 154, through outlet 116, and into collection device 160. Thus, as described above, isolating an initial volume of bodily fluid in isolation chamber 114 prior to collecting or procuring one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes. Furthermore, in some embodiments, the positioning of control device 100 prevents control device 100 from transitioning to the second state prior to collecting and isolating the initial volume in isolation chamber 114.

[0061] Figure 2 shows a cross-sectional side view of a fluid control device 200 according to one embodiment. Fluid control device 200 may be similar, at least in form and / or function, to fluid control device 100 described above with reference to Figure 1. Accordingly, portions of fluid control device 200 that may be similar to portions of fluid control device 100 will not be described in further detail herein.

[0062] As shown in FIG. 2, fluid control device 200 (also referred to herein as a "control device" or "device") includes an inlet 212, an outlet 216, and an isolation chamber 210. As described above with reference to control device 100, inlet 212 is configured to be placed in fluid communication with a source of bodily fluid (e.g., via a lumen-containing device such as a needle, IV catheter, PICC line, etc.) for receiving a flow of bodily fluid therefrom. Outlet 216 is configured to be fluidly coupled to a fluid collection device, syringe, and / or other intermediate bodily fluid transfer device or container (not shown in FIG. 2), such as, for example, a transfer device similar to that described in the '510 publication.

[0063] As described above with reference to fluid control device 100, control device 200 includes one or more fluid flow paths 213 between inlet 212 and isolation chamber 212, and / or one or more fluid flow paths 254 between inlet 212 and outlet 216. Control device 200 may have any suitable shape, size, and / or configuration. For example, in some embodiments, device 200 may be substantially similar, at least in shape and / or function, to device 100 described above with reference to FIG. 1. In some embodiments, device 200 may include first portion 224 and second portion 225. As shown in FIG. 2, in some embodiments, second portion 225 may be, for example, a bypass and / or diversion portion physically coupled to and in selective fluid communication with first portion 224. Additionally, device 200 includes and / or forms a first junction 217 at a location where a first end (e.g., an inlet end) of second portion 225 is joined to first portion 224, and a second junction 218 at a location where a second end (e.g., an outlet end) of second portion 225 is joined to first portion 224. That is, device 200 can be configured to have and / or form a bifurcation (e.g., second portion 225) at first junction 217 that rejoins at second junction 218, for example. In some embodiments, second portion 225 can form and / or have a D-shaped configuration and / or arrangement. In other embodiments, first portion 224 and / or second portion 225 can form and / or have any suitable configuration and / or arrangement (e.g., a serpentine configuration, a loop configuration, a spiral configuration, any suitable geometric configuration, and / or the like). In some embodiments, first portion 224 and / or second portion 225 of device 200 can include and / or be formed by flexible tubes or the like having any suitable shape and / or size and that are reconfigurable or movable to be placed in any suitable configuration and / or arrangement.

[0064] In some embodiments, isolation chamber 214 of device 200 may be formed by and / or included in second portion 225 of device 200. Coupling of second portion 225 to first portion 224 (e.g., at first junction 217) can selectively place isolation chamber 214 in fluid communication with inlet 212 via fluid flow path 213 and first junction 217. Similarly, coupling of second portion 225 to first portion 224 (e.g., at second junction 218) can selectively place isolation chamber 214 in fluid communication with outlet 216, via fluid flow path 254 and second junction 218, and / or a fluid collection device coupled to outlet 216 via fluid flow path 254 and second junction 218.

[0065] As described in further detail herein, isolation chamber 214 is configured to (1) selectively receive a flow and / or volume of bodily fluid from inlet 212 and (2) segregate (e.g., separate, fractionate, contain, retain, isolate, etc.) the flow and / or volume of bodily fluid therein. Isolation chamber 214 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, isolation chamber 214 can have any suitable size, volume, and / or fluid capacity, such as, for example, those described above with respect to isolation chamber 114. In some embodiments, at least a portion of fluid flow path 213 can extend through a portion of device 200 and / or first junction 217 to form and / or define at least a portion of isolation chamber 214. In other embodiments, first junction 217 and / or isolation chamber 214 can include a flow control mechanism and / or the like that can at least temporarily isolate fluid flow path 213 from isolation chamber 214. In some embodiments, device 200 can include, form, and / or define one or more flow controllers, such as flow controllers 221, 222, and / or 215. Flow controllers 221, 222, and / or 215 may be, for example, valves, membranes, diaphragms, restrictors, vents, selectively permeable members (e.g., fluid-impermeable barriers or seals that at least selectively allow gas or air to pass therethrough, such as blood barriers like Porex®, and / or the like), ports, etc. (collectively referred to herein as “flow controllers”) that are positioned at one or more desired locations and configured to selectively (at least partially) control the flow of fluid into / out of isolation chamber 214 and / or other appropriate portions of device 200.

[0066] 2, flow controllers 221 and 222 may each be a valve configured to have a particular, desired, and / or predetermined cracking pressure, etc. Valves 221 and / or 222 may be, for example, in-line or lined pipe insert (LP) valves, which may be configured for suitable placement anywhere along a pipe or tubing system. In some embodiments, valves 221 and / or 222 may be configured to remain in a closed state, restricting or substantially preventing the flow of air or liquid, until a particular amount of pressure exceeding the cracking pressure is applied to valves 221 and / or 222, respectively, transitioning valves 221 and / or 222 from a closed state to an open state.

[0067] In some embodiments, valves 221 and / or 222 and other additional valves (not shown) can each be configured to have a variable cracking pressure and be positioned at any suitable location within and / or along device 200. For example, in some embodiments, valve 221 can be positioned within first portion 224 of device 200 and downstream of first junction 217, and valve 222 can be positioned within second portion 225 of device 200 and upstream of and / or before second junction 218, as shown in FIG. 2 . In some embodiments, device 200 can be configured such that valve 221 has a greater cracking pressure than valve 222, thereby allowing valves 221 and 222 to be opened sequentially using an applied vacuum source. For example, the cracking pressure of each valve 221, 222 and the pressure provided by the negative pressure source can be collectively configured to achieve a continuous and / or otherwise desired first flow of bodily fluid toward and / or into the isolation chamber 214, and then a desired second flow of bodily fluid toward the outlet 216 and fluid collection device.

[0068] By way of example, in some embodiments, a negative pressure source (e.g., a fluid collection device and / or the like) can define a vacuum having a magnitude of approximately 8 pounds per square inch (psi). Thus, when a negative pressure source is coupled to outlet 216, pressure is transmitted to both valves 221 and 222. In some embodiments, valve 221 can have a cracking pressure of, for example, 3.4 psi, and valve 222 can have a cracking pressure of, for example, 0.017 psi. In this manner, the negative pressure differential resulting from coupling a negative pressure source to outlet 216 can, in turn, transition valve 222 (having a lower cracking pressure) from a substantially closed configuration or state to a substantially open configuration or state before transitioning valve 221 (having a higher cracking pressure) from a substantially closed configuration or state to a substantially open configuration or state. In some examples, this sequential opening of the valves (i.e., valve 222 before valve 221) may be operable to direct a fluid flow (e.g., a first flow) to the isolation chamber 214 and then a fluid flow (e.g., a second flow) to a fluid collection device and / or a negative pressure source coupled to the outlet 216, as further described below.

[0069] Device 200, in some embodiments, can include one or more flow controllers in the form of a material that is selectively permeable to air but impermeable or at least selectively permeable to fluids (e.g., liquids). For example, device 200 can include one or more membranes made of a material that allows the flow of air or transmits a vacuum from a negative pressure source, but does not allow or transmit the flow of bodily fluids (e.g., hydrophobic). In some embodiments, device 200 can include a flow controller that can be in a first or initial state or configuration before interacting with bodily fluids or any other suitable form of actuation, and then transition and / or be transitioned to a second state or configuration upon interacting with bodily fluids or any other suitable form of actuation. For example, in some embodiments, such a flow controller can be in an initial or first state that selectively allows the flow of air therethrough while substantially restricting and / or preventing the flow of bodily fluids therethrough. Upon interaction with bodily fluids (or any other suitable fluids), the flow controller can transition to a second state, in which the flow controller can be substantially impermeable to the flow of air and bodily fluids therethrough.

[0070] As shown in the embodiment depicted in FIG. 2, device 200 can include a flow controller 215 in the form of a membrane, porous material, absorbent material, or the like. Flow controller 215 can be of any suitable shape, size, and / or configuration. In some embodiments, flow controller 215 can be formed from a porous material having any suitable pore size that allows air flow therethrough while restricting and / or substantially preventing liquid flow therethrough. For example, in some embodiments, flow controller 215 can be a membrane having a diameter of about 17 mm and a pore size of about 0.45 micrometers (μm), or the like. In other embodiments, flow controller 215 can be a membrane and / or the like having any suitable diameter (e.g., 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 10 mm, 15 mm, 20 mm, 30 mm, or more, and / or any diameter therebetween). Similarly, in other embodiments, flow controller 215 can be a membrane and / or the like having any suitable pore size. In some embodiments, the pore size of the flow controller, membrane, and / or the like can be based on, for example, the type of fluid (e.g., bodily fluid) being drawn, collected, and / or sequestered, the amount or type of particulate matter expected in the fluid flow (e.g., bodily fluid flow and / or air flow), the vacuum source used, and / or the magnitude of the expected negative pressure differential, and / or any other suitable factors or considerations.

[0071] As shown, flow controller 215 is disposed within device 200 to selectively establish fluid communication between second portion 225 and / or isolation chamber 214 and outlet 216 via junction 218. Thus, with flow controller 215 configured as a semi-permeable member, flow controller 215 can be configured to at least temporarily allow gas or air to be transferred from second portion 225 and / or isolation chamber 214 of device 200 through flow controller 215 and junction 218 to fluid flow path 254, as described in further detail herein, and can be configured to restrict and / or substantially prevent the flow of liquid (e.g., bodily fluid) between second portion 225 and / or isolation chamber and fluid flow path 254 (e.g., via junction 218). Although not shown, in some embodiments, device 200 can include one or more actuators or the like configured to control and / or transition the state of flow controller 215. Outlet 216 of device 200 is in fluid communication with and / or configured to be placed in fluid communication with fluid flow paths 213 and / or 254. Outlet 216 may be any suitable outlet, opening, port, lock, seal, coupler, etc., and is configured to be fluidly coupled to a fluid collection device, such as a sample reservoir, syringe, container, and / or other sample vessel. In some embodiments, outlet 216 may be monolithically formed with the fluid collection device or may be at least temporarily coupled to the fluid collection device, as described above with reference to outlet 116 of device 100. The fluid collection device may be any suitable collection system for containing bodily fluids, such as, for example, any of those described in detail above with respect to collection device 160. More specifically, in some embodiments, outlet 216 may be configured to couple to a vacuum sample reservoir. In some other embodiments, outlet 216 may be configured to couple to a negative pressure source downstream of outlet 216 while also being coupled to a fluid collection device.In this manner, a user can couple a fluid collection device to the outlet 216 to initiate the flow of bodily fluid from the patient, whereby a first or initial portion of the bodily fluid is transferred into and thereby isolated by the isolation chamber 214, and any subsequent portions or volumes of the bodily fluid bypass and / or otherwise divert from the isolation chamber 214 and flow into the fluid collection device.

[0072] As described above, device 200 can be used to obtain a bodily fluid sample with reduced contamination from microorganisms, such as those present on the skin, and / or the like. For example, in some instances, a user, such as a doctor, physician, nurse, phlebotomist, technician, or the like, can operate device 200 to establish fluid communication between inlet 212 and a bodily fluid source (e.g., a patient's vein). Once inlet 212 is placed in fluid communication with the bodily fluid source (e.g., a portion of the patient), outlet 216 can be fluidly coupled to a fluid collection device. As described above, in the embodiment shown in FIG. 2 , the fluid collection device can be a negative pressure source and / or configured to generate a negative pressure differential. For example, the fluid collection device can be a vacuum reservoir or container, a syringe, a pump, and / or any other negative pressure source that defines a negative pressure. In other embodiments, the fluid collection device can be a container, reservoir, or device configured to be coupled to a separate negative pressure source.

[0073] By coupling outlet 216 to a fluid collection device and / or a negative pressure source, at least a portion of fluid flow path 254 is selectively exposed to negative pressure in or through the fluid collection device. As described above, flow controller 215 and / or valves 221 and 222 can be configured to selectively control the flow of fluid through device 200. More specifically, coupling outlet 216 to a fluid collection device and / or a negative pressure source creates a negative pressure differential within fluid flow path 254, which in turn exposes valves 221 and 222 to negative pressure. As described above, in some embodiments, valve 221 can have a greater cracking pressure (e.g., 3.4 psi) compared to the cracking pressure of valve 222 (e.g., 0.017 psi). Additionally, flow controller 215 upstream of valve 222 can be a membrane in an initial or first state, wherein flow controller 215 is permeable to the flow of air or gas. In some examples, such an arrangement causes the valve 222 to transition from a closed state to an open state, thereby transmitting negative pressure through the valve 222 and the flow controller 215 to the isolation chamber 214 .

[0074] Thus, an operable negative pressure differential is created when bodily fluid is drawn from a bodily fluid source (e.g., a patient) through inlet 212 and into fluid flow path 213. Furthermore, when valve 222 is in an open state and valve 221 is in a closed state, bodily fluid can flow through fluid flow path 213 and into isolation chamber 214 (e.g., via junction 217). As described above with reference to control device 100, control device 200 is configured such that when a volume of bodily fluid is transferred to and / or through inlet 212, an initial portion of the volume of bodily fluid (also referred to herein as an “initial volume” or “first volume”) flows from inlet 212, through at least a portion of fluid flow path 213 and / or junction 217, and into isolation chamber 214. That is, in some embodiments, control device 200 can be placed in a first or initial state such that an initial portion or volume of bodily fluid can flow into or through at least a portion of fluid flow path 213 and / or junction 217 and into isolation chamber 214. When device 200 is in the first or initial state, valve 221 is in a closed state, so that bodily fluid does not pass through valve 221 and does not substantially enter fluid flow path 254 .

[0075] As described above, the control device 200 may be in an initial state when the flow controller 222 (valve) is in an open state, thus allowing an initial amount of bodily fluid to be drawn into the isolation chamber 214 by a negative pressure differential. In some examples, the bodily fluid can flow through the second portion 225 (e.g., the isolation chamber 214) until the flow reaches the flow controller 215 (e.g., a selectively permeable membrane or member, as described above). The membrane 215 may be in its initial or first state, and thus may be permeable to air but impermeable to liquid. In this manner, the membrane 215 isolates, separates, separates, segregates, and / or otherwise prevents direct liquid communication between the fluid flow path 213 and the isolation chamber 214. Additionally, the inlet 212 is exposed to a negative pressure differential through the isolation chamber 214. In other words, the negative pressure within the fluid collection device can create a negative pressure (or negative pressure differential) within at least a second portion 225 (e.g., isolation chamber 214) of device 200 that is operable to draw an initial flow of bodily fluid from inlet 212, through at least a portion of fluid flow path 213 and / or junction 217, and into isolation chamber 214 when control device 200 is in a first or initial state.

[0076] When the flow controller 215 is in a first or initial state, the flow controller 215 can pass a flow of fluid (e.g., gas or air) in response to negative pressure in a sample reservoir (or syringe or other potential energy source used to generate negative pressure), as described above with reference to device 100. The flow controller 215 (e.g., a selectively permeable membrane or member) can be configured to transition from a first state, permeable to air and impermeable to liquid, to a second state, impermeable to air and impermeable to liquid, in response to the flow of an initial amount of bodily fluid into the isolation chamber 214. For example, maximally filling the isolation chamber 214 can correspond to and / or otherwise cause bodily fluid to saturate, wet, and / or impregnate the flow controller 215 (e.g., membrane material), transitioning the flow controller 215 from the first state to the second state. In the second state, the flow controller 215 is impermeable to air and liquid, thereby limiting and / or substantially preventing fluid communication between the isolation chamber 214 and a negative pressure source (e.g., a fluid collection device). In other words, the isolation chamber 214 can be isolated from the negative pressure source in response to an initial volume of bodily fluid filling the isolation chamber 214.

[0077] The initial portion and / or amount of bodily fluid may be any suitable volume of bodily fluid, as described in detail with reference to control device 100. For example, in some instances, the initial volume may be related to and / or at least partially based on an amount or volume of bodily fluid sufficient to fully wet or saturate flow controller 215 (e.g., a selectively permeable membrane or member). In other words, in some embodiments, the initial volume of bodily fluid may be a volume sufficient to transition flow controller 215 to a second state (e.g., a saturated or fully wetted state). In some embodiments, flow controller 215 is disposed in a sealed configuration upon transitioning to the second state. That is, by saturating and / or fully wetting flow controller 215 (e.g., a semipermeable material), flow controller 215 is disposed in a sealed configuration in which flow controller 215 substantially prevents the flow of liquids and gases therethrough.

[0078] After the initial volume of bodily fluid is transferred and / or diverted to the isolation chamber 214, the control device 200 can transition to its second state or operational mode to sequester, separate, hold, contain, isolate, etc., the initial volume within the isolation chamber 214. For example, as described above, the flow controller 215 is disposed in a sealed configuration, which fluidly isolates the isolation chamber 214 from the fluid flow path 254. Further, the transition of the flow controller 215 can be responsive to an initial amount of bodily fluid filling the isolation chamber 214. Thus, the initial amount of bodily fluid within the isolation chamber 214 can limit and / or substantially prevent further amounts of bodily fluid from being transferred to the isolation chamber 214. Thus, the initial amount and / or portion of the bodily fluid is sequestered and / or retained within the isolation chamber 214. As described above, in some examples, contaminants, such as microorganisms present on skin removed during a venipuncture event, are entrained and / or contained within the initial volume of bodily fluid and, therefore, are isolated therein when the initial volume of bodily fluid is sequestered within the isolation chamber 214.

[0079] When flow controller 215 is in the second state (e.g., an impermeable or sealed state), the negative pressure that would otherwise be applied on or through isolation chamber 214 is now applied on or through fluid flow path 254, and thus to flow controller 221. In some examples, the magnitude of the negative pressure can build and / or increase within fluid flow path 254 until the negative pressure is sufficient to transition flow controller 221 from its first state to its second state. More specifically, if flow controller 221 is a valve, the negative pressure can be increased until it is sufficient to overcome the cracking pressure of valve 221. Thus, when the valve is in its open state (and / or when flow controller 221 is otherwise in the second state), inlet 212 is exposed to a negative pressure differential through fluid flow path 213. When the fluid collection device is fluidly coupled to the outlet 216 and the control device 200 is in the second state (e.g., an initial volume of bodily fluid is isolated in or by the isolation chamber 214), any subsequent volume(s) of bodily fluid can flow from the inlet 212, through the fluid flow paths 213 and 254, through the flow controller 221 (e.g., a valve), through the outlet 216, and into the fluid collection device. Thus, as described above, isolating the initial volume of bodily fluid in the isolation chamber 214 prior to collecting or procuring one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes. Furthermore, in some embodiments, the configuration of the control device 200 prevents the control device 200 from transitioning to the second state prior to collecting and isolating the initial volume in the isolation chamber 214.

[0080] 2, in some embodiments, control device 200 may include an actuator and / or the like configured to move between a first state and a second state (e.g., via a user-applied force). In other embodiments, the control device may include any suitable member, device, mechanism, etc. configured to selectively establish fluid communication between two or more fluid flow paths (e.g., fluid flow paths 213 and 254).

[0081] In some examples, it may be desirable to adjust and / or control the magnitude of the negative pressure differential to which isolation chamber 214 is exposed. Although not shown in FIG. 2 , device 200 can include one or more means for reducing and / or controlling the magnitude of the negative pressure differential. For example, in some embodiments, device 200 can include a restrictive flow path(s) or a portion of a flow path having a smaller diameter than fluid flow paths 213 and / or 254. For example, in some embodiments, one or more restrictive flow paths can have a diameter of about 1.0 micrometer (μm), about 10.0 μm, about 100.0 μm, about 1000.0 μm, about 10,000.0 μm, about 100,000.0 μm, and / or any suitable diameter therebetween. In other embodiments, the restrictive flow paths can have a diameter less than 1.0 μm or greater than 100,000.0 μm. In such embodiments, the restricted flow path may have a smaller diameter, resulting in a smaller magnitude of negative pressure being applied through isolation chamber 214 than would be the case if the restricted flow path had a larger diameter. Further, in some such embodiments, one or more restricted flow paths may be gas flow paths configured to receive a flow of gas or air, for example, rather than a flow of liquid (e.g., bodily fluid). In some embodiments, the diameter of the restricted flow path may be small enough to restrict and / or prevent the flow of liquid therethrough.

[0082] In some embodiments, a restricted flow path can be disposed, for example, between junction 218 and flow controller 215, such that flow of bodily fluids and / or other liquids is substantially prevented by flow controller 215 (e.g., a selectively permeable barrier or seal). More specifically, in some embodiments, a restricted flow path can be disposed, for example, between flow controller 222 (e.g., a valve) and flow controller 215 (e.g., a selectively permeable membrane or member). Thus, flow controller 222 can be exposed to a negative pressure greater than the negative pressure to which flow controller 215 is exposed. In such embodiments, the greater negative pressure can facilitate the transition of flow controller 222 from its first state to its second state. For example, in some embodiments, if flow controller 222 is a valve, this arrangement can allow the valve to be exposed to a negative pressure differential sufficient to overcome the cracking pressure of the valve.

[0083] While pressure modulation is described above as being based on the diameter of the restriction flow path, it should be understood that this is provided by way of example only and not limitation. For example, in some embodiments, the control device can include any suitable number of restriction 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 restriction flow paths. In such embodiments, each of the restriction flow paths can have a diameter between about 1.0 μm and about 100.0 μm, between about 1.0 μm and about 10.0 μm, or between about 1.0 μm and about 5.0 μm. In some embodiments, the plurality of restriction flow paths can be configured to function as a flow controller that (1) selectively provides a flow path between the isolation chamber 214 and the outlet 216 that exposes the isolation chamber 214 to a negative pressure differential, and (2) is configured to selectively allow the passage of gas and / or air while substantially preventing the passage of liquid (e.g., bodily fluids). Other means for regulating the amount of negative pressure to which the isolation chamber is exposed can include, for example, a porous material, a valve, a membrane, a diaphragm, a specific restriction, a vent, a deformable member or flow channel, and / or any other suitable means. In some embodiments, the flow controller 215 can be a selectively permeable membrane or member having a predetermined and / or desired porosity to provide the desired amount of negative pressure regulation.

[0084] In some embodiments, adjusting and / or controlling the amount of pressure to which isolation chamber 214 may be exposed can, in turn, adjust the amount of pressure applied to bodily fluids and / or within a patient's veins. In some examples, such pressure adjustment can, for example, reduce the likelihood of hemolysis of a blood sample and / or venous collapse. In some examples, the ability to adjust and / or control the amount or magnitude of negative pressure can enable control device 200 to be used across a wide range of patients who may have physiological challenges, such that negative pressure is often needed to facilitate the collection of bodily fluids such as blood (e.g., the pressure difference between atmospheric pressure and the patient's vascular pressure may not be sufficient to promote a consistent and sufficiently strong flow), but not so much that abrupt forces flatten, dip, collapse, and / or otherwise inhibit patency and ability to collect blood.

[0085] FIG. 3 illustrates a fluid control device 300 according to another embodiment. The fluid control device 300 (also referred to herein as a "control device" or a "device") may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the fluid control device 300 may be similar in form and / or function to the fluid control device 100 described above with reference to FIG. 1 and / or the fluid control device 200 described above with reference to FIG. 2. Accordingly, portions of the fluid control device 300 that may be similar to portions of the fluid control devices 100 and / or 200 will not be described in further detail herein.

[0086] As described above with reference to fluid control device 200 shown in FIG. 2, fluid control device 300 shown in FIG. 3 includes an inlet 312, an outlet 316, and an isolation chamber 314. Inlet 312 is configured to be placed in fluid communication with a source of bodily fluid (e.g., via a lumen-containing device such as a needle, IV catheter, PICC line, etc.) to receive a flow of bodily fluid therefrom. Outlet 316 is configured to be fluidly coupled to a fluid collection device, a syringe, a vacuum container, and / or other intermediate bodily fluid transfer device or vessel (not shown in FIG. 3), such as, for example, a transfer device similar to those described in the '510 publication. Additionally, control device 300 includes and / or defines one or more fluid flow paths 313 between inlet 312 and isolation chamber 314 and / or one or more fluid flow paths 354 between inlet 312 and outlet 316.

[0087] 3 , in some embodiments, the second portion 325 can be, for example, a bypass and / or diversion portion physically coupled to and in selective fluid communication with the first portion 324. Additionally, the device 300 includes and / or forms a first junction 317 at a location where a first end (e.g., an inlet end) of the second portion 325 is coupled to the first portion 324, and includes and / or forms a second junction 318 at a location where a second end (e.g., an outlet end) of the second portion 325 is coupled to the first portion 324. That is, the device 300 can be configured to have and / or form a bifurcation (e.g., the second portion 325) at the first junction 317, which is rejoined at the second junction 318. In some embodiments, first portion 324 and / or second portion 325 of device 300 may include and / or be formed as flexible tubes or the like having any suitable shape and / or size and that are reconfigurable or movable to be placed in any suitable configuration and / or arrangement.

[0088] As described in further detail herein, isolation chamber 314 is configured to (1) receive a flow and / or volume of bodily fluid from inlet 312 and (2) isolate (e.g., separate, fractionate, contain, retain, isolate, etc.) the flow and / or volume of bodily fluid therein. Isolation chamber 314 may have any suitable shape, size, and / or configuration. For example, in some embodiments, isolation chamber 314 can have any suitable size, volume, and / or fluid capacity, such as, for example, those described above with respect to isolation chambers 114 and / or 214. In some embodiments, at least a portion of fluid flow path 313 can extend through a portion of device 300 to form and / or define at least a portion of isolation chamber 314. In some embodiments, isolation chamber 314 of device 300 may be substantially similar in form and / or function to one or more isolation chambers 114 and / or 214. Accordingly, portions of isolation chamber 314 may not be described in further detail herein.

[0089] 3, isolation chamber 314 may be formed by and / or included in second portion 325 of device 300 and may be selectively placed in fluid communication with (1) inlet 312 via fluid flow path 313 and first junction 317, and (2) outlet 316 via fluid flow path 354 and second junction 318. In this manner, isolation chamber 314 is configured to (1) selectively receive a flow and / or volume of bodily fluid from inlet 312 and (2) isolate (e.g., separate, fractionate, contain, retain, isolate, etc.) the flow and / or volume of bodily fluid therein.

[0090] In some embodiments, fluid control device 300 can include and / or define one or more flow controllers. A flow controller can include, for example, a valve, membrane, diaphragm, restrictor, vent, selectively permeable member (e.g., a fluid-impermeable barrier or seal that at least selectively allows gas or air to pass, such as a blood barrier like Porex®, and / or the like), port, or the like (collectively referred to herein as a “flow controller”) that is appropriately positioned and configured to selectively control (at least in part) the flow of fluid into / out of isolation chamber 314 and / or any other suitable portion of device 300. Some embodiments of device 300 can include flow controllers, such as selectively permeable member 315, check valve 322, and dissolvable member 323, as shown in FIG. 3, that are positioned to allow, direct, control, and / or prevent the flow of fluid in one or more specific directions under specific states of function and / or conditions.

[0091] 3 , second portion 325 of device 300 can include check valve 322 and selectively permeable member 315. For example, in some embodiments, check valve 322 and / or selectively permeable member 315 can be disposed on, at, or near the proximal or second end of isolation chamber 314. In other words, check valve 322 and selectively permeable member 315 can be disposed at, on, or near the outlet or outlet portion of isolation chamber 314. In other words, check valve 322 and / or selectively permeable member can be disposed at, on, or near the end of isolation chamber 314 that is closer to second junction 318 than to first junction 317. In some embodiments, check valve 322 and / or selectively permeable member 315 can be integrated into at least a portion of second junction 318. In some embodiments, check valve 322 can be substantially similar to valve 222 described above with reference to device 200. For example, in some embodiments, check valve 322 can be configured to have a desired cracking pressure as described above with reference to valve 222. Thus, check valve 322 can be configured to selectively control fluid flow between, for example, fluid flow path 354 and isolation chamber 314, as described above with reference to device 200. As such, check valve 322 is not described in further detail herein. Furthermore, in some embodiments, device 300 need not include a check valve and / or any other suitable valve.

[0092] The selectively permeable member may be of any suitable shape, size, and / or configuration. For example, in some embodiments, the selectively permeable member 315 may be, e.g., a membrane, a porous material, an absorbent material, a hydrophilic or hydrophobic material, a selectively permeable barrier, etc. In some embodiments, the selectively permeable member 315 may be substantially similar to the flow controller 215 (e.g., a selectively permeable member and / or a membrane), and thus, aspects of the selectively permeable member 315 will not be described in further detail herein. The selectively permeable member 315 may be configured to at least temporarily allow gas or air to be transferred from the second portion 325 and / or isolation chamber 314 of the device 300 through the selectively permeable member 315 and junction 318 to the fluid flow path 354, and may be configured to restrict and / or substantially prevent the flow of liquid (e.g., bodily fluid) between the second portion 325 and / or isolation chamber and the fluid flow path 354 (e.g., via junction 318). In some embodiments, selectively permeable member 315 can be in a first or initial state, where when device 300 is in its first state and / or configuration, selectively permeable member 315 allows the flow of air or gas to be transferred therethrough. As described in further detail herein, selectively permeable member 315 can transition to and / or otherwise be in a second state or configuration in which selectively permeable member 315 is substantially impermeable to all fluids (gases and / or liquids) when device 300 is in its second state and / or configuration.

[0093] In some embodiments, dissolvable member 323 can be positioned at any suitable location within the first portion of device 300. For example, in some embodiments, dissolvable member 323 can be positioned at and / or near first junction 317, as shown in FIG. 3. In some embodiments, dissolvable member 323 can be integral with junction 317 and / or at least a portion of junction 317. In this manner, dissolvable member 323 can be upstream of selectively permeable member 315, for example.

[0094] As described in further detail herein, the dissolvable member 323 can be configured to transition from a first or initial state to a second state in response to contact with a fluid, such as a bodily fluid. In some embodiments, for example, the dissolvable member 323 can be disposed within and / or near the first junction 317 to separate the inlet 312 from the fluid flow path 354 when the device 300 is in the first or initial state. In response to and / or after transferring an initial volume of bodily fluid to the isolation chamber 314, the device 300 can transition from the first or initial state to the second state. In some embodiments, when the device 300 is in the second state, the dissolvable member 323 can substantially dissolve, thus establishing fluid communication between the inlet 312 and the fluid flow path 354. In some examples, for example, when the initial volume of bodily fluid flows into the isolation chamber 314, a portion of the bodily fluid can contact the dissolvable member 323. As described in further detail herein, contact with bodily fluids may in turn initiate dissolution of the dissolvable member 323, such that when the device 300 is placed in its second state and / or configuration, the dissolvable member 323 at least substantially dissolves, thereby placing the inlet 312 in fluid communication with the fluid flow path 354.

[0095] As described above, device 300 can be used to obtain a bodily fluid sample with reduced contamination from microorganisms, such as those present on the skin, and / or the like. For example, in some instances, a user, such as a doctor, physician, nurse, phlebotomist, technician, or the like, can operate device 300 to establish fluid communication between inlet 312 and a bodily fluid source (e.g., a patient's vein). Once inlet 312 is placed in fluid communication with the bodily fluid source (e.g., a portion of the patient), outlet 316 can be fluidly coupled to a fluid collection device. As described above, in the embodiment shown in FIG. 3 , the fluid collection device can be, for example, a vacuum reservoir, a syringe, and / or any container that defines a negative pressure or can be coupled to a downstream source of negative pressure.

[0096] By coupling outlet 316 to a fluid collection device, at least a portion of fluid flow path 354 is selectively exposed to a negative pressure within the fluid collection device. The configuration of device 300 when in its first or initial state includes one or more flow controllers in its first state or configuration. For example, selectively permeable member 315, check valve 322, and dissolvable member 323 can each be in their first state and / or configuration when outlet 316 is coupled to a fluid collection device. In response to the negative pressure, check valve 322 can be configured to transition from a substantially closed state (e.g., its first configuration or state) to a substantially open state (e.g., its second configuration and / or state). For example, in some instances, establishing fluid communication between outlet 316 and a fluid collection device can expose check valve 322 to a negative pressure differential, e.g., exceeding the cracking pressure of check valve 322. Thus, check valve 322 can be placed in its second state and / or configuration. In other embodiments, device 300 need not include a check valve and / or other suitable valve. In such embodiments, the negative pressure differential that would otherwise be operable to transition check valve 322 is instead applied across selectively permeable member 315, which is substantially similar to when check valve 322 is in the second or open state.

[0097] As described above, selectively permeable member 315 and dissolvable member 323 are each in their first state or configuration when outlet 316 is coupled to a fluid collection device. Thus, selectively permeable member 315 can be configured to allow the flow of air, gas, and / or negative pressure while blocking and / or preventing the flow of liquid therethrough, as described above with reference to flow controller 215. Furthermore, when dissolvable member 323 is in its first state or configuration, dissolvable member 323 can be configured to block, isolate, and / or obstruct fluid communication between inlet 312 and fluid flow path 354, for example, thereby not allowing the flow of fluid (air or liquid or negative pressure) therethrough. Thus, coupling outlet 316 to a fluid collection device exposes isolation chamber 314 to the negative pressure of the fluid collection device, thereby creating a negative pressure differential operable to draw bodily fluid from a bodily fluid source (e.g., a patient) through inlet 312 and into isolation chamber 314.

[0098] As described above with reference to control devices 100 and 200, control device 300 is positioned so that when a volume of bodily fluid is transferred to and / or through inlet 312, an initial portion of the volume of bodily fluid (also referred to herein as an “initial volume” or “first volume”) flows from inlet 312 and into isolation chamber 314. That is, in some embodiments, device 300 is in its first or initial state in which an initial portion or volume of bodily fluid can flow from inlet 312 into isolation chamber 314 in response to a negative pressure differential associated with the fluid collection device. In other words, a negative pressure within the fluid collection device can create a negative pressure (or negative pressure differential) within at least a portion of isolation chamber 314 that is operable to draw an initial flow of bodily fluid from inlet 312 into isolation chamber 314 when control device 300 is in the first or initial state. As described in detail above, in some instances, it may be desirable to adjust and / or control the magnitude of the negative pressure differential by any suitable means as described herein.

[0099] The initial portion and / or amount of bodily fluid may be any suitable volume of bodily fluid, as described in detail with reference to control devices 100 and / or 200. For example, in some instances, the initial volume may be related to and / or based at least in part on an amount or volume of bodily fluid sufficient to fully wet or saturate membrane 315. In other words, in some embodiments, the initial volume of bodily fluid may be a volume sufficient to transition selectively permeable member 315 to a second state (e.g., a saturated or fully wetted state). As described above with reference to flow controller 215, selectively permeable member 315 is placed in a sealed configuration upon transitioning to the second state. Thus, by transitioning selectively permeable member 315 to the second state, flow through selectively permeable member 315 is sequestered, blocked, isolated, separated, separated, and / or otherwise prevented.

[0100] After the initial volume of bodily fluid is transferred and / or diverted into isolation chamber 314, control device 300 can transition to its second state or mode of operation to sequester, separate, hold, contain, isolate, etc., the initial volume within isolation chamber 314. As described above, selectively permeable member 315 is disposed in a sealed configuration, thus substantially preventing fluid flow therethrough. In this embodiment, the positioning of control device 300 causes at least a portion of the negative pressure that would otherwise be imparted via selectively permeable member 315 when selectively permeable member 315 is disposed in the sealed configuration to instead be imparted on and / or within fluid flow path 354. However, the negative pressure can be isolated within fluid flow path 354 until dissolvable member 323 transitions from its first state and / or configuration to its second state and / or configuration (e.g., at least partially dissolves).

[0101] Once selectively permeable member 315 is sealed in its second state and isolation chamber 314 is filled to capacity with the withdrawn initial volume of bodily fluid, the amount of bodily fluid at least temporarily retained at and / or near junction 317 can bring a sufficient amount of bodily fluid into contact with dissolvable member 323 to transition dissolvable member 323 from its first state to its second state. In other words, filing isolation chamber 314 can bring a sufficient volume or amount of bodily fluid into contact with dissolvable member 323 to substantially dissolve dissolvable member 323, thereby transitioning it to its second state or configuration. The transition of dissolvable member 323 is, in turn, sufficient to transition fluid control device 300 from its first state to its second state.

[0102] When the dissolvable member 323 is in its second state and / or configuration (e.g., at least partially dissolved), negative pressure within the fluid flow path 354 can be applied to the fluid flow path 313 and / or the inlet 312. In some embodiments, the positioning of the dissolvable member 323 causes the inlet 312 to be exposed to a greater amount and / or magnitude of negative pressure as the dissolvable member 323 dissolves. In other words, the dissolvable member 323 can be configured to dissolve for a predetermined and / or desired period of time, which can in turn modulate and / or control the amount of negative pressure to which the inlet 312 is exposed. In some embodiments, the dissolvable member 323 can include one or more tunable, adjustable, and / or similar features configured to adjust (e.g., increase or decrease) the rate at which the dissolvable member 323 transitions to its second state (e.g., dissolved). When dissolvable member 323 transitions to its second state and / or configuration, negative pressure within fluid flow path 354 urges, draws, and / or directs the flow of bodily fluid from inlet 312 and first junction 317, via fluid flow path 354 and outlet 316, and into the fluid collection device. Additionally, the sealing state of selectively permeable member 315 and the presence of check valve 322 (or other suitable flow controller) can restrict and / or substantially prevent the flow of bodily fluid from fluid flow path 354 through second junction 318 toward isolation chamber 314. In some embodiments, the transition of selectively permeable member 315 and dissolvable member 323 from their respective first states to their respective second states is operable to sequester and / or retain an initial portion of bodily fluid within isolation chamber 314. As described in more detail above, in some instances, contaminants, such as microorganisms present on skin removed during a venipuncture event, are entrained and / or contained in the initial volume of bodily fluid and, therefore, are sequestered therein when the initial volume is sequestered within isolation chamber 314.

[0103] When the fluid collection device is fluidly coupled to outlet 316 and control device 300 is in the second state (e.g., an initial volume of bodily fluid is isolated in or by isolation chamber 314), any subsequent volume(s) of bodily fluid can flow from inlet 312, through fluid flow paths 313 and 354, through outlet 316, and into the fluid collection device. Thus, as described above, isolating an initial volume of bodily fluid in isolation chamber 314 prior to collecting or procuring one or more sample volumes of bodily fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes. Furthermore, in some embodiments, the configuration of control device 300 does not allow control device 300 to transition to the second state prior to collecting and isolating the initial volume in isolation chamber 314.

[0104] 4 illustrates a fluid control device 400 according to one embodiment. Fluid control device 400 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, fluid control device 400 may be substantially similar, at least in form and / or function, to devices 100, 200, and / or 300 described above with reference to FIGS. 1, 2, and 3, respectively. Accordingly, portions of fluid control device 400 that may be similar to portions of fluid control devices 100, 200, and / or 300 will not be described in further detail herein.

[0105] As shown in FIG. 4 , fluid control device 400 (also referred to herein as a “control device” or “device”) includes an inlet 412, an outlet 416, and an isolation chamber 414. As described above with reference to control devices 100, 200, and / or 300, inlet 412 is configured to be placed in fluid communication with a source of bodily fluid (e.g., via a lumen-containing device such as a needle, an IV catheter, a PICC line, and / or the like) for receiving a flow of bodily fluid therefrom. Outlet 416 is configured to be fluidly coupled to a fluid collection device, syringe, transfer adapter, and / or the like (not shown in FIG. 4 ). Additionally, control device 400 includes and / or defines one or more fluid flow paths 413 between inlet 412 and at least isolation chamber 414, and / or one or more fluid flow paths 454 between inlet 412 and outlet 416.

[0106] 4, in some embodiments, the device 400 can include a first portion 424 and a second portion 425. As shown in FIG. 4, in some embodiments, the second portion 425 can be, for example, a bypass and / or diversion portion physically coupled to and in selective fluid communication with the first portion 424. Additionally, the device 400 can include and / or form a first junction 417 at a location where a first end (e.g., an inlet end) of the second portion 425 is coupled to the first portion 424, and a second junction 418 at a location where a second end (e.g., an outlet end) of the second portion 425 is coupled to the first portion 424. That is, the device 400 can be configured to have and / or form a bifurcation (e.g., the second portion 425) at the first junction 417 that rejoins the second portion 425 at the second junction 418. In some embodiments, first portion 424 and / or second portion 425 of device 400 can include and / or be formed as flexible tubes or the like having any suitable shape and / or size and that are reconfigurable or movable to be placed in any suitable configuration and / or arrangement.

[0107] Isolation chamber 414 may have any suitable shape, size, and / or configuration. For example, in some embodiments, isolation chamber 414 can have any suitable size, volume, and / or fluid capacity, such as, for example, those described above with respect to isolation chamber 114. In some embodiments, isolation chamber 414 of device 400 may be substantially similar in form and / or function to one or more of isolation chambers 114, 214, and / or 314. Thus, portions of isolation chamber 414 may not be described in further detail herein.

[0108] 4, isolation chamber 414 may be formed by and / or included in second portion 425 of device 400 and may be selectively placed in fluid communication with (1) inlet 412 via fluid flow path 413 and first junction 417, and (2) outlet 416 via fluid flow path 454 and second junction 418. In this manner, isolation chamber 414 is configured to (1) selectively receive a flow and / or volume of bodily fluid from inlet 412 and (2) isolate (e.g., separate, fractionate, contain, retain, isolate, etc.) the flow and / or volume of bodily fluid therein.

[0109] The second portion 425 and / or isolation chamber 414 of device 400 can specifically include, form, and / or define a flow controller 415 disposed on, at, or near the proximal or second end of the isolation chamber 414. In other words, the flow controller 415 can be disposed at, on, or near the outlet or outlet portion of the isolation chamber 414. In other words, the flow controller can be disposed at, on, or near the end of the isolation chamber 414 that is closer to the second junction 418 than the first junction 417. In some embodiments, the flow controller 415 can be, for example, a membrane, a porous material, an absorbent material, a hydrophilic or hydrophobic material, a selectively permeable barrier, etc. The flow controller 415 can be of any suitable shape, size, and / or configuration. In some embodiments, the flow controller 415 can be substantially similar to the flow controller 215 and / or the flow controller 315 and, therefore, will not be further detailed herein.

[0110] As described in detail above, flow controller 415 is disposed within second portion 425 of the device to selectively establish fluid communication between second portion 425 and / or isolation chamber 414 and outlet 416 via junction 418. Thus, because flow controller 415 is configured to selectively control the flow of fluid therethrough (e.g., configured as a semi-permeable member), flow controller 415 can be configured to at least temporarily allow gas or air to be transferred from second portion 425 and / or isolation chamber 414 of device 400 through flow controller 415 and junction 418 to fluid flow path 454, as described in further detail herein, and can be configured to restrict and / or substantially prevent the flow of liquid (e.g., bodily fluid) between second portion 425 and / or isolation chamber and fluid flow path 454 (e.g., via junction 418).

[0111] As described above with reference to devices 100, 200, and / or 300, device 400 may include one or more flow controllers configured to selectively control the flow of gas or liquid (e.g., air or bodily fluid, respectively) through device 400. For example, in the embodiment shown in FIG. 4, device 400 includes first flow restrictor 431 and second flow restrictor 432. Flow restrictors 431 and 432 (and / or any other suitable flow controllers not shown in FIG. 4 but which may be included) may be included at predetermined and / or desired locations along first portion 424 and / or second portion 425 of device 400 to control, manipulate, divert, and / or direct the flow of air, liquid (e.g., bodily fluid), and / or negative pressure. Flow restrictors 431 and 432 may be configured with various flow-allowing or flow-impeding characteristics. For example, in some embodiments, flow restrictor 431 and / or flow restrictor 432 can have and / or can be defined with any suitable internal cross-sectional shape, size, and / or configuration to selectively allow fluid to flow therethrough, as further detailed herein.

[0112] 4, flow restrictors 431 and 432 may each be flow restrictors configured to define a flow path therethrough having one or more particular, desired, and / or predetermined characteristics. Furthermore, in some embodiments, second flow restrictor 432 (e.g., a flow restrictor disposed between second junction 418 and isolation chamber 414) may have a less restrictive flow path than the flow path of first flow restrictor 431 (e.g., a flow restrictor disposed between outlet 416 and first junction 417). In other words, a pressure difference sufficient to allow a fluid (e.g., gas or liquid) to pass through second flow restrictor 432 may be less than a pressure difference sufficient to allow a fluid (e.g., gas or liquid) to pass through first flow restrictor 431. Thus, first flow restrictor 431 and second flow restrictor 431 may be similar to first valve 221 and second valve 222 described above with reference to FIG. 2.

[0113] As described in further detail herein, the arrangement of flow restrictors 431 and 432 allows for when a negative pressure source (e.g., a fluid collection device and / or the like) is coupled to outlet 416, a negative pressure differential to result in flow through second flow restrictor 432 prior to flow through first flow restrictor 431. In some examples, this sequential opening of the flow restrictors (e.g., flow restrictor 432 before flow restrictor 431) may be operable to direct a fluid flow (e.g., a first flow) into isolation chamber 414 and then direct a fluid flow (e.g., a second flow) to the fluid collection device and / or negative pressure source coupled to outlet 416. Stated another way, in some embodiments, device 400 can be configured to transition between a first state in which (1) inlet 412 is disposed in fluid communication with a second portion 425 of device 400 (e.g., isolation chamber 414) and (2) second flow restrictor 432 establishes selective fluid communication between isolation chamber 414 and outlet 416, and a second state in which (1) second flow restrictor 432 separates isolation chamber 414 from outlet 416 and (2) first flow restrictor 431 establishes selective fluid communication between inlet 412 and first portion 424 of device 400 and / or outlet 416.

[0114] As described above, for devices 100, 200, and 300, device 400 can be used to procure a bodily fluid sample with reduced contamination. In some examples, a user, such as a doctor, physician, nurse, phlebotomist, technician, or the like, can operate device 400 to establish fluid communication between inlet 412 and a bodily fluid source (e.g., a patient's vein). For example, in some embodiments, a user can couple inlet 412 to an inlet device, a needle, an indwelling catheter or IV, and / or any other suitable lumen-containing device. Once inlet 412 is placed in fluid communication with a bodily fluid source (e.g., a portion of a patient), outlet 416 can be fluidly coupled to a fluid collection device. As described herein, the fluid collection device can be any suitable reservoir, syringe, pump, and / or device configured to define and / or generate a negative pressure. In other embodiments, outlet 416 can be coupled to a fluid collection device, which is in turn coupled to a downstream negative pressure source.

[0115] The control device 400 may be in a first or initial state prior to coupling the outlet 416 to the fluid collection device. By coupling the outlet 416 to the fluid collection device, at least a portion of the fluid flow path 454 is selectively exposed to a negative pressure within the fluid collection device. For example, when the device 400 is in its initial or first state, the flow controller 415 may be in its first state or configuration, whereby the flow controller 415 is permeable to the flow of air or gas but impermeable to the flow of liquid (e.g., bodily fluid). Furthermore, the arrangement of the flow restrictors 431 and 432 makes the first flow restrictor 431 more restrictive to the flow of liquid or air therethrough than the second flow restrictor 432.

[0116] The negative pressure differential defined and / or generated by the fluid collection device results in the suction or drawing of fluid (e.g., air or gas) from the fluid flow path 454. In other words, the negative pressure within and / or generated by the fluid collection device results in a negative pressure differential within the fluid flow path 454. Due to the arrangement of the flow restrictors 431 and 432 and the flow controller 415, the negative pressure differential within the fluid flow path 454 can result in a negative pressure differential through and / or across the outlet 416, the second junction 418, the second flow restrictor 432, the flow controller 415, and the isolation chamber 414. Furthermore, the first flow restrictor 431 is configured to be more restrictive than the second flow restrictor 432, such that flow through the second flow restrictor 432 can at least partially maintain a magnitude of negative pressure within the fluid flow path 454 below an otherwise operable negative pressure threshold magnitude to induce fluid flow through the first flow restrictor 431. That is, when device 400 is in the first state, the negative pressure in fluid flow path 454 is sufficient to cause flow through second flow restrictor 432 but insufficient to cause flow through first flow restrictor 431. Thus, the negative pressure in and / or generated by the fluid collection device (coupled to outlet 416) can draw air and / or gas through flow controller 415 and second flow restrictor 432 and into fluid flow path 454. Although not shown in FIG. 4 , in some embodiments, device 400 can include a vent or one-way valve configured to allow air or gas drawn from isolation chamber 414 to be vented to the atmosphere. In other embodiments, the air and / or gas can be transferred to the fluid collection device, which can then, directly or indirectly, allow the air or gas to be vented. Thus, the negative pressure in and / or generated by the fluid collection device can cause a negative pressure (or negative pressure differential) within at least a portion of isolation chamber 414.

[0117] The negative pressure in isolation chamber 414 may be operable to draw an initial flow of bodily fluid from inlet 412, through fluid flow path 413 and first junction 417, and into isolation chamber 414 when control device 400 is in a first or initial state. In some examples, it may be desirable to adjust and / or control the magnitude of the negative pressure differential by any suitable means as described herein, including manipulating the permeability and / or permeability of flow restrictors 431 and / or 432 and / or flow controller 415. In some embodiments, flow restrictors 431 and / or 432 may be configured with one or more external actuators, controllers, and / or adjusters configured to control the amount of flow through flow restrictors 431 and / or 432 (e.g., by changing or adjusting the inner diameter of flow restrictors 431 and / or 432). In some other embodiments, flow restrictors 431 and / or 432 can be configured to adjust and / or change their characteristics that allow fluid flow therethrough based on time, interaction with one or more fluids, and / or any other suitable parameters. In some embodiments, the structure of flow restrictors 431 and / or 432 can be manipulated (e.g., squeeze, compress, pinch, compress, etc.) to adjust the degree of negative pressure.

[0118] In some embodiments, adjusting and / or controlling the amount of pressure to which isolation chamber 414 may be exposed can, in turn, adjust the amount of pressure (i.e., negative pressure) applied to bodily fluids and / or within a patient's veins. In some examples, such pressure adjustment can, for example, reduce the likelihood of hemolysis of a blood sample and / or vein collapse. In some examples, the ability to adjust and / or control the amount or magnitude of negative pressure allows control device 400 to be used across a wide range of patients who may have physiological challenges, whereby negative pressure is often required to facilitate the collection of bodily fluids such as blood, but not so much that abrupt forces flatten, dip, collapse, and / or otherwise inhibit patency and ability to collect blood, as described above.

[0119] The initial portion and / or amount of bodily fluid may be any suitable volume of bodily fluid, as detailed with reference to control devices 100, 200, and / or 300. For example, in some instances, the initial volume may be related to and / or based at least in part on an amount or volume of bodily fluid sufficient to fully wet or saturate the flow controller 415. In other words, in some embodiments, the initial volume of bodily fluid may be a volume sufficient to transition the flow controller 415 to a second state (e.g., a saturated state or a fully wet or sealed state) in which the flow controller 415 is placed in a sealed state and / or configuration. In some embodiments, transitioning the flow controller 415 to the second state segregates, blocks, isolates, separates, separates, and / or otherwise prevents the flow of air, gas, and / or liquid (e.g., bodily fluid) through the flow controller 415.

[0120] After the initial volume of bodily fluid has been transferred and / or diverted into the isolation chamber 414, the control device 400 may be in and / or placed in its second state or mode of operation, where it may sequester, separate, hold, contain, isolate, etc. the initial volume within the isolation chamber 414. As described above, the flow controller 415 in the second state or sealed state substantially prevents the flow of fluid, including air and liquid, therethrough (e.g., into the second flow restrictor 432 and / or fluid flow path 454). Thus, the isolation chamber 414 is fluidly isolated from the fluid collection device and / or negative pressure source, and thus may allow a pressure differential between the isolation chamber 414 and, for example, the inlet 412, to equalize, thereby restricting and / or substantially stopping the flow of bodily fluid into the isolation chamber 414.

[0121] As previously discussed, the amount of negative pressure sufficient to induce and / or allow fluid flow through the first flow restrictor 431 may be greater than the amount of negative pressure sufficient to induce and / or allow fluid flow through the second flow restrictor 432. In this embodiment, the positioning of the control device 400 causes at least a portion of the negative pressure originally provided through the flow controller 415 to increase and / or build up within the fluid flow path 454 sufficient to induce and / or allow fluid flow through the first flow restrictor 431 when the flow controller 415 is placed in the second or sealed configuration. Thus, when the device 400 is in its second state, the negative pressure provided by the fluid collection device and / or negative pressure source can create a negative pressure within the fluid flow path 454 sufficient to allow bodily fluid to flow from the inlet 412, through the first flow restrictor 431, the fluid flow path 454, and the outlet 416 into the fluid collection device. As discussed above, in some instances, contaminants, such as, for example, microorganisms present on the skin dislodged during the venipuncture event, are entrained and / or contained in the initial volume of bodily fluid and are therefore sequestered within the isolation chamber 414. Furthermore, as described for devices 100, 200, 300, in some embodiments, the configuration of control device 400 prevents the device from transitioning to the second state prior to collecting and sequestering the initial volume within isolation chamber 414.

[0122] While flow restrictors 431 and 432 have been described above, particularly with reference to FIG. 4 , in other embodiments, the fluid control device may include other forms of flow controllers and / or restrictors in addition to and / or instead of those described in connection with apparatus 400. In some embodiments, the fluid control device may include any other suitable means or combination of means for controlling the flow of fluid therethrough. For example, FIGS. 5-7 illustrate three different embodiments of flow controllers and / or flow restrictors, each according to a different embodiment. FIG. 5 illustrates flow restrictor 433, which defines an orifice or channel for the passage of air and / or fluid. In this embodiment, flow restrictor 433 can have a relatively large inner diameter and a relatively long length. On the other hand, FIG. 6 illustrates flow restrictor 434, which defines an orifice or channel having a relatively small inner diameter (e.g., smaller than the inner diameter of flow restrictor 433) and a relatively short length (e.g., shorter than the length of flow restrictor 433).

[0123] As will be appreciated, adjusting the length and / or diameter of the orifice or channel of a flow restrictor can allow for adjustment of the magnitude of the pressure differential sufficient to induce and / or effect the flow of a fluid (e.g., bodily fluid) through the orifice or channel. For example, in some embodiments, the flow restriction and / or restrictive flow path can have a suitable diameter of about 1.0 micrometer (μm), about 10.0 μm, about 100.0 μm, about 1000.0 μm, about 10,000.0 μm, about 100,000.0 μm, and / or any suitable diameter therebetween. In other embodiments, the restrictive flow path can have a diameter less than 1.0 μm or greater than 100,000.0 μm. In such embodiments, a restrictive flow path having a smaller diameter may be designed so that the magnitude of pressure (e.g., negative pressure) sufficient to induce or draw fluid flow through the restrictive flow path is greater than the magnitude of pressure sufficient to induce or draw fluid flow through a restrictive flow path having a larger diameter. Similarly, a longer restrictive flow path may be designed so that the magnitude of pressure (e.g., negative pressure) sufficient to induce or draw fluid flow through the restrictive flow path is greater than the magnitude of pressure sufficient to induce or draw fluid flow through a restrictive flow path having a shorter length.

[0124] 7 illustrates a flow controller 435 including a porous material 436 disposed therein. In such embodiments, the porosity and / or permeability of the porous material 436 can be adjusted to adjust the magnitude of the pressure differential sufficient to induce and / or effect the flow of a fluid (e.g., a bodily fluid) through an orifice or channel. Other examples of flow restrictors and / or flow controllers include, but are not limited to, flow controllers in which the restricted or restrictive region includes a region of varying cross-sectional diameter that allows fluid flow, or includes a structure (e.g., a porous material) designed to selectively permit or inhibit fluid or air flow as needed. Other embodiments can include, for example, valves, actuators, selectively permeable membranes and / or materials, etc.

[0125] 8-10 illustrate a fluid control device 500 according to one embodiment. FIG. 8, for example, illustrates a top view of device 500, while FIGS. 9 and 10 illustrate cross-sectional views of device 500 in a first state and a second state, respectively. Fluid control device 500 may be similar, at least in form and / or function, to any of fluid control devices 100, 200, 300, and / or 400. Accordingly, portions of fluid control device 500 that may be similar to portions of fluid control devices 100, 200, 300, and / or 400 will not be further detailed herein.

[0126] As shown in FIGS. 8-10 , fluid control device 500 (also referred to herein as a “control device” or “device”) includes an inlet 512 and an outlet 516, as well as an isolation chamber 514. As described above with reference to control devices 100, 200, 300, and / or 400, inlet 512 is configured to be placed in fluid communication with a source of bodily fluid (e.g., via a lumen-containing device such as a needle) to receive a flow of bodily fluid therefrom. Outlet 516 is configured to be fluidly coupled to a fluid collection device (not shown). Inlet 512, outlet 516, and the fluid collection device may be substantially similar to those described above and, therefore, will not be described in further detail herein.

[0127] As described above, control device 500 is configured to (1) receive an initial flow and / or volume of bodily fluid via inlet 512 and (2) segregate (e.g., separate, fractionate, contain, hold, isolate, etc.) the flow and / or volume of bodily fluid within segregation chamber 514. Control device 500 may be of any suitable shape, size, and / or configuration. For example, in some embodiments, device 500 can have a size based at least in part on the volume of bodily fluid to be at least temporarily stored within segregation chamber 514. For example, in the embodiments shown in FIGS. 8-10 , device 500 can be arranged in and / or have a substantially “in-line” configuration in which portions of device 500 are at least partially aligned.

[0128] Device 500 includes and / or defines one or more fluid flow paths 513 between inlet 512 and at least isolation chamber 514, and / or one or more fluid flow paths 554 between inlet 512 and outlet 516. In some embodiments, device 500 can include a first portion 524 and a second portion 525. As shown in FIGS. 9 and 10 , in some embodiments, second portion 525 can be, for example, a bypass and / or diversion portion physically coupled to and in selective fluid communication with first portion 524. Additionally, device 500 includes and / or forms a junction 517 at a location where a first end (e.g., inlet end) of first portion 524 and a first end (e.g., inlet end) of second portion 525 each couple to inlet 512. In some embodiments, first portion 524 and second portion 525 can be collectively disposed within a housing or otherwise at least partially surrounded by a common structure. In other embodiments, first portion 524 and / or second portion 525 of device 500 may include and / or be formed by flexible tubes or the like having any suitable shape and / or size and that are reconfigurable or movable to be placed in any suitable configuration and / or arrangement.

[0129] Isolation chamber 514 may have any suitable shape, size, and / or configuration. For example, in some embodiments, isolation chamber 514 can have any suitable size, volume, and / or fluid capacity, such as, for example, those described above with respect to isolation chamber 114. Isolation chamber 514 may be formed by and / or included in second portion 525 of device 500 and may be selectively placed in fluid communication with (1) inlet 512 via fluid flow path 513 and first junction 517, and (2) outlet 516 via fluid flow path 554 and flow controller 515 (described further herein). In some embodiments, isolation chamber 514 of device 500 may be substantially similar in form and / or function to one or more isolation chambers 114, 214, 314, and / or 414. Thus, portions of isolation chamber 514 may not be described further herein.

[0130] 9 and 10 , the second portion 525 and / or isolation chamber 514 of the device 500 can specifically include, form, and / or define a flow controller 515 disposed on, at, or near the proximal or second end of the isolation chamber 514. In other words, the flow controller 515 can be disposed on, at, or near the outlet or outlet portion of the isolation chamber 514 to establish selective fluid communication between the isolation chamber 514 and the fluid flow path 554. The flow controller 515 can be of any suitable shape, size, and / or configuration. In some embodiments, the flow controller 515 can be, for example, a membrane, a porous material, an absorbent material, a hydrophilic or hydrophobic material, a selectively permeable barrier, or the like. In some embodiments, flow controller 515 can be configured to at least temporarily allow gas or air to be transferred from second portion 525 and / or isolation chamber 514 of device 500, through flow controller 515, and into fluid flow path 554, and can be configured to restrict and / or substantially prevent the flow of liquid (e.g., bodily fluid) between second portion 525 and / or isolation chamber 514 and fluid flow path 554. In some embodiments, flow controller 515 can be substantially similar in at least form and / or function to flow controllers 215, 315, and / or 415, and therefore aspects of flow controller 515 will not be further detailed herein.

[0131] In some embodiments, device 500 can include one or more flow controllers in addition to flow controller 515 configured to selectively control, direct, divert, and / or manipulate the flow of fluid through at least a portion of flow paths 513 and / or 554. In some embodiments, such flow controllers can be configured to selectively control the flow of fluid through device 500, for example, in response to an external force or actuation (e.g., manual intervention by a user), or automatically (e.g., after a period of time and / or in response to a predetermined force, pressure, flow rate, fluid volume, saturation level, etc.). For example, in this embodiment, device 500 includes diaphragm 576 that is movably disposed within the body of device 500 and configured to at least partially define isolation chamber 514. In some embodiments, the diaphragm 576 can be configured to transition, flip, move, switch, deform, etc. from a first configuration or state ( FIG. 9 ) to a second configuration or state ( FIG. 10 ) in response to a negative pressure differential within and / or across at least a portion of the device 500 (e.g., a negative pressure differential associated with and / or resulting from coupling to the outlet 516 of the fluid collection device).

[0132] In some embodiments, the diaphragm 576 can be coupled to a piercing member 578 and can be configured to move through at least a portion of the device 500 in response to movement of the diaphragm 576. As shown in FIGS. 9 and 10 , the device 500 includes a film, barrier, and / or frangible member 574 (referred to herein as a “barrier”) configured to at least temporarily isolate, separate, and / or isolate the fluid flow path 513 (e.g., an inlet fluid flow path) from the fluid flow path 554 (e.g., an outlet fluid flow path). In some embodiments, the arrangement of the diaphragm 576 and / or piercing member 578 can be such that, when the diaphragm 576 transitions from its first state, configuration, and / or position to its second state, configuration, and / or position, the piercing member 578 transitions and / or moves through a portion of the device 500 to pierce, puncture, rupture, break, and / or otherwise reconfigure the barrier 574.

[0133] More specifically, as shown in FIG. 9 , the diaphragm 576 can have a concave shape relative to the barrier 574 when in its first or initial state, and the piercing member 578 coupled to the diaphragm 576 can be decoupled and / or separated from the barrier 574. As such, the barrier 574 can be in the first or initial state in which the barrier 574 is sealed, unbroken, unpunctured, and / or otherwise acts to fluidly isolate the fluid flow path 513 from the fluid flow path 554. As shown in FIG. 10 , the diaphragm 576 can have a convex shape relative to the barrier 574 when in its second or subsequent state, and the piercing member 578 coupled to the diaphragm 576 can engage, contact, and / or otherwise reconfigure the barrier 574, thereby piercing and / or defining an opening therethrough. In other words, as illustrated in Figures 9 and 10, respectively, device 500 and / or diaphragm 576 are configured to move between a first or initial state in which fluid flow path 513 is fluidly isolated and / or isolated from fluid flow path 554 so that fluid flow (e.g., bodily fluid) can flow from inlet 512, through at least a portion of fluid flow path 513, and into isolation chamber 514, and a second or subsequent state in which fluid flow path 513 is in fluid communication with fluid flow path 554 so that fluid flow (e.g., bodily fluid) can flow from inlet 512, through barrier 574 and fluid flow path 554, and into outlet 516. In some embodiments, the transition of device 500 and / or diaphragm 576 from the first state to the second state may increase the volume of device 500 defined between diaphragm 576, flow controller 515, and one or more walls of isolation chamber 514 (i.e., the volume of isolation chamber 514 increases), thus creating a negative pressure therein operable to draw at least a portion of the initial volume of bodily fluid through inlet 512 and into isolation chamber 514, as further described below.

[0134] As described above, for devices 100, 200, 300, and / or 400, device 500 can be used to procure a bodily fluid sample with reduced contamination. For example, in some instances, control device 500 can be in a first or initial state, and a user can operate device 500 to establish fluid communication between inlet 512 and a bodily fluid source (e.g., a patient's vein) and between outlet 516 and a fluid collection device (e.g., a sample container, syringe, reservoir, etc.). With device 500 in its initial or first state, coupling outlet 516 to the fluid collection device selectively exposes at least a portion of fluid flow path 554 to a negative pressure within the fluid collection device. Additionally, when device 500 is in its initial or first state, flow controller 515 can be in its first state or configuration, whereby flow controller 515 is permeable to the flow of air or gas but impermeable to the flow of liquid (e.g., bodily fluid). Barrier 574 is also in its first or initial state such that barrier 574 fluidly isolates fluid flow path 513 from fluid flow path 554. In this manner, a negative pressure differential defined and / or generated by the fluid collection device creates a suction force within fluid flow path 554, which, in turn, is applied on or through flow controller 515. Thus, coupling outlet 516 to the fluid collection device exposes isolation chamber 514 to the negative pressure defined and / or generated by the fluid collection device, thereby creating a negative pressure differential operable to draw an initial volume and / or amount of bodily fluid from a bodily fluid source (e.g., a patient's vasculature), through inlet 512, at least a portion of fluid flow path 513, and junction 517, and into isolation chamber 514. Although not shown in FIGS. 8-10 , in some embodiments, device 500 may include any suitable device and / or mechanism configured to modulate the negative pressure to which isolation chamber 514 is exposed, as described in detail above.

[0135] The initial portion and / or amount of bodily fluid may be any suitable volume of bodily fluid, as detailed with reference to control devices 100, 200, 300, and / or 400. For example, in some examples, the initial volume may be related to and / or at least partially based on an amount or quantity of bodily fluid sufficient to fully wet or saturate flow controller 515 (e.g., transition flow controller 515 from its first or selectively open state to a second or sealed state). When flow controller 515 is in its second or sealed state, flow controller 515 substantially prevents the flow of fluid, including air and liquid, thereby isolating and / or fluidly isolating isolation chamber 514 from fluid flow path 554. As a result, in some examples, for example, a pressure differential between isolation chamber 514 and inlet 512 may be equalized such that the flow of bodily fluid into isolation chamber 514 is limited and / or substantially stopped.

[0136] In this embodiment, the positioning of control device 500 causes at least a portion of the negative pressure originally provided through flow controller 515 to increase and / or build up within fluid flow path 554 sufficiently to transition diaphragm 576 from its first state or configuration ( FIG. 9 ) to its second state or configuration ( FIG. 10 ), for example. In some embodiments, diaphragm 576 may invert and / or move from a configuration concave relative to barrier 574 to a configuration convex relative to barrier 574. Further, as described above, the transition of diaphragm 576, in turn, moves piercing member 578 such that piercing member 578 engages, penetrates, punctures, opens, ruptures, and / or otherwise reconfigures barrier 574, thereby placing fluid flow path 513 in fluid communication with fluid flow path 554. Thus, when device 500 is in its second state, the negative pressure provided by the fluid collection device and / or negative pressure source can create a negative pressure in fluid flow path 554 sufficient to allow bodily fluid to flow from inlet 512, through fluid flow path 513, barrier 574, fluid flow path 554, and outlet 516 into the fluid collection device.

[0137] As discussed above, in some instances, contaminants, such as, for example, microorganisms present on the skin dislodged during the venipuncture event, are entrained and / or contained in the initial volume of bodily fluid and are therefore sequestered within the isolation chamber 514. Further, as described for devices 100, 200, 300, and / or 400, in some embodiments, the configuration of control device 500 prevents the device from transitioning to the second state prior to collecting and sequestering the initial volume within isolation chamber 514.

[0138] Although flow controller 515 is shown in FIGS. 8-10 as being in fluid communication with fluid flow path 554 without any features, devices, mechanisms, and / or means disposed therebetween for regulating the amount of negative pressure, in other embodiments, the fluid control device can include any suitable features, devices, mechanisms, and / or means configured to regulate the amount or magnitude of negative pressure. For example, FIGS. 11 and 12 are schematic diagrams of fluid control device 600 in a first state and a second state, respectively, according to another embodiment. Fluid control device 600 (also referred to herein as a "control device" or "device") can be of any suitable shape, size, and / or configuration. For example, in some embodiments, device 600 can be substantially similar, at least in form and / or function, to any of devices 100, 200, 300, 400, and / or 500 described herein. More specifically, device 600 can be substantially similar, at least in form and / or function, to device 500 described above with reference to FIGS. 8-10. Therefore, portions and / or aspects of fluid control device 600 will not be further detailed herein.

[0139] As shown in FIGS. 11 and 12 , device 600 includes an inlet 612, an outlet 616, and an isolation chamber 614. Additionally, device 600 includes and / or defines one or more fluid flow paths 613 between inlet 612 and at least isolation chamber 614, and / or one or more fluid flow paths 654 between inlet 612 and outlet 616. Inlet 612 is configured to be placed in fluid communication with a bodily fluid source to receive bodily fluid therefrom. Outlet 616 is configured to be fluidly coupled to a fluid collection device substantially similar to those described above. Isolation chamber 614 may be included in and / or formed by a portion of device 600 and may be selectively placed in fluid communication with (1) inlet 612 via fluid flow path 613 and (2) outlet 616 via fluid flow path 654 and flow controller 615. Flow controller 615 may be of any suitable shape, size, and / or configuration and may be configured to selectively control, enable, permit, and / or transport the flow of fluid therethrough. For example, as described above, flow controller 615 may be a selectively permeable member configured to be selectively permeable to gases (e.g., air) and substantially impermeable to liquids (e.g., bodily fluids). In some embodiments, inlet 612, outlet 616, isolation chamber 614, and flow controller 615 may be substantially similar to inlet 512, outlet 516, isolation chamber 514, and flow controller 515, respectively, as described above with reference to device 500 shown in FIGS. 8-10 . Accordingly, portions and / or aspects of inlet 612, outlet 616, isolation chamber 614, and / or flow controller 615 will not be described in further detail herein.

[0140] 11 and 12 , in some embodiments, second portion 625 can be, for example, a bypass and / or diversion portion that (1) is physically coupled to and selectively fluidly communicates with first portion 624, and (2) includes and / or forms isolation chamber 614. Additionally, device 600 includes and / or forms junction 617 at a location where a first end (e.g., an inlet end) of first portion 624 and a first end (e.g., an inlet end) of second portion 625 each couple to inlet 612. In some embodiments, first portion 624 and second portion 625 can be collectively disposed within a housing or otherwise at least partially surrounded by a common structure. In other embodiments, first portion 624 and / or second portion 625 of device 600 may include and / or be formed by flexible tubes or the like having any suitable shape and / or size and that are reconfigurable or movable to be placed in any suitable configuration and / or arrangement.

[0141] As described above with reference to device 500, device 600 includes a diaphragm 676 movably disposed within at least a portion of device 600 and a piercing member 678 coupled to diaphragm 676. In some embodiments, diaphragm 676 can define at least a portion of isolation chamber 614. In some embodiments, diaphragm 676 and piercing member 678 can be substantially similar, at least in form and / or function, to diaphragm 576 and piercing member 578, respectively, of device 500. For example, as described above with reference to diaphragm 576 of device 500, diaphragm 676 is configured to transition between a first state in which fluid flow path 613 is fluidly isolated from fluid flow path 654 and a second state in which fluid flow path 613 is in fluid communication with fluid flow path 654, as described in further detail herein.

[0142] While device 500 is shown and described above as including a single barrier 574 configured to selectively isolate and / or otherwise prevent fluid communication between fluid flow paths 513 and 554, in the embodiment shown in FIGS. 11 and 12 , device 600 includes a set of barriers configured to selectively prevent or selectively allow fluid flow through device 600. For example, in some embodiments, device 600 may include two barriers 674 and 675. Each of barriers 674 and 675 may be substantially similar in at least form and / or function to barrier 574 of device 500 described above with reference to FIGS. 9 and 10 . Thus, upon deployment of device 600, when diaphragm 676 is in its first state, piercing member 678 may be decoupled and / or separated from barriers 674 and 675, thus allowing it to remain sealed, closed, and / or substantially undeformed ( FIG. 11 ). However, when diaphragm 676 transitions to that state, penetrating member 678 can move within device 600 such that penetrating member 678 engages, contacts, penetrates, punctures, and / or otherwise reconfigures each of barriers 674 and 675, causing barriers 674 and 675 to transition to a non-sealing, open, penetrated, and / or deformed state (see FIG. 12 ), as described in further detail herein.

[0143] As noted above, device 600 can include one or more features, mechanisms, devices, and / or means for regulating the negative pressure applied through one or more portions of device 600. For example, as shown in Figures 11 and 12, device 600 includes and / or defines a restricted flow path 631 (also referred to herein as a "flow restrictor") configured to establish fluid communication between, for example, flow controller 615 and fluid flow path 654. As described above with reference to flow restrictors 431 and 432 of device 400 shown in Figure 4, flow restrictor 631 can be configured to define a restricted and / or limited flow path therethrough having one or more particular, desired, and / or predetermined characteristics. As described in further detail herein, the placement of flow restrictor 631 may be such that when a negative pressure source (e.g., a fluid collection device and / or the like) is coupled to outlet 616, a negative pressure differential may result in a limited and / or regulated flow or suction force through flow restrictor 631, which in turn results in a limited and / or regulated negative pressure being provided to flow controller 615. Thus, flow restrictor 631 may be substantially similar, at least in form and / or function, to flow restrictor 432 described above with reference to FIG.

[0144] As described above for devices 100, 200, 300, 400, and / or 500, device 600 can be used to procure a bodily fluid sample with reduced contamination. For example, in some examples, control device 600 can be in a first or initial state (see, e.g., FIG. 11 ), and a user can operate device 600 to establish fluid communication between inlet 612 and a bodily fluid source (e.g., a patient's vein) and between outlet 616 and a fluid collection device (e.g., a sample container, syringe, reservoir, etc.). With device 600 in its first or initial state, coupling outlet 616 to the fluid collection device selectively exposes at least a portion of fluid flow path 654 to a negative pressure within the fluid collection device. When control device 600 is in the first state, diaphragm 676, flow controller 615, and barriers 674 and 675 can each be in a respective first state. 11 , barriers 674 and 675 are in a first or sealed state such that barrier 674 (e.g., a first barrier) fluidly isolates and / or separates fluid flow path 613 from flow restrictor 631 (e.g., a restricted flow path), and barrier 675 (e.g., a second barrier) fluidly isolates and / or separates fluid flow path 613 (e.g., an inlet flow path) from fluid flow path 654 (e.g., an outlet flow path).

[0145] 11 , the barrier 675 fluidly isolates at least a portion of the fluid flow path 654 from other portions of the device 600, and thus the negative pressure in the fluid flow path 654 is transferred and / or applied through the flow restrictor 631. Thus, a regulated and / or desired portion of the negative pressure in and / or generated by the fluid collection device (coupled to the outlet 616) is transferred through the flow restrictor 631 and, in turn, provided to the flow controller 615. Furthermore, when the flow controller 615 is in its first state (e.g., the selectively permeable state), the regulated and / or desired portion of the negative pressure within and / or generated by the fluid collection device can provide a negative pressure (or negative pressure differential) within at least a portion of the isolation chamber 614 that is operable to draw an initial flow of bodily fluid from the inlet 612, through at least a portion of the fluid flow path 613, and into the isolation chamber 614, as described above with reference to devices 100, 200, 300, 400, and / or 500, for example.

[0146] The initial portion and / or amount of bodily fluid may be any suitable volume of bodily fluid, as detailed with reference to control devices 100, 200, 300, 400, and / or 500. For example, in some examples, the initial volume may be related to and / or at least partially based on an amount or quantity of bodily fluid sufficient to fully wet or saturate flow controller 615 (e.g., transition flow controller 615 from its first or selectively open state to a second or sealed state). When flow controller 615 is in its second or sealed state, flow controller 615 substantially isolates, blocks, isolates, separates, sorts, and / or otherwise prevents the flow of fluid (e.g., gas and liquid) through flow controller 615, thereby fluidly isolating isolation chamber 614 from fluid flow path 654. As a result, in some examples, for example, a pressure differential between isolation chamber 614 and inlet 612 may be equalized such that the flow of bodily fluid into isolation chamber 614 is restricted and / or substantially stopped.

[0147] As described above for device 500, the arrangement of control device 600 causes at least a portion of the negative pressure that would otherwise be applied through flow controller 615 to instead be applied to the concave surface or surface of diaphragm 676 when flow controller 615 is placed in its second or sealed state. The increased negative pressure on the concave surface and / or surface of diaphragm 676 may be operable to reverse, switch, and / or transition diaphragm 676 from its first state (e.g., concave relative to barrier 674) to its second state (e.g., convex relative to barrier 674). In some embodiments, flow restrictor 631 may be configured to adjust and / or regulate the magnitude or change in magnitude of the negative pressure applied to diaphragm 676 in substantially the same manner as adjusting and / or regulating the negative pressure applied to or through flow controller 615. In some examples, adjusting the negative pressure applied to the diaphragm 676 can in turn adjust, reduce, and / or control the rate at which the diaphragm 676 transitions from its first state to its second state.

[0148] As described above, the translation of diaphragm 676, in turn, moves piercing member 678 coupled thereto, causing piercing member 678 to engage, penetrate, puncture, open, rupture, and / or otherwise reconfigure each of barriers 674 and 675 such that each barrier 674 and 675 is placed in an open state and / or otherwise defines an opening through which fluid may flow. In other embodiments, barrier 674 can be configured to form a substantially fluid-tight seal with an outer surface of piercing member 678 when piercing member 678 penetrates therethrough. Furthermore, as described above with reference to device 500, the opening in barrier 675 places fluid flow path 613 in fluid communication with fluid flow path 654. In this manner, device 600 may be in and / or placed in its second state, and negative pressure provided by the fluid collection device and / or negative pressure source may create a negative pressure in fluid flow channel 654 sufficient to allow bodily fluid to flow from inlet 612, through fluid flow channel 613, barrier 675, fluid flow channel 654, and outlet 616 into the fluid collection device (not shown). As discussed above, in some instances, contaminants, such as microorganisms present on skin removed during a venipuncture event, may be entrained and / or contained in the initial volume of bodily fluid and thus be isolated within isolation chamber 614. Further, as described for devices 100, 200, 300, 400, and / or 500, in some embodiments, the positioning of fluid control device 600 may prevent the device from transitioning to the second state prior to collecting and isolating the initial volume within isolation chamber 614.

[0149] Although device 600 is described above as including a piercing member 678 that pierces barrier 675 to place device 600 in a second state, in other embodiments, the device can include any suitable member configured to transition any suitable barrier. For example, FIGS. 13 and 14 show device 700 according to one embodiment. Device 700 can be substantially similar to device 600, and thus similar portions will not be described in further detail herein. However, device 700 (FIGS. 13 and 14) can differ from device 600 (FIGS. 11 and 12) by including a diaphragm 776 that includes and / or is coupled to a rod, pusher, plunger, actuator, and / or the like (for simplicity, referred to herein as an “actuator”). Furthermore, rather than including barriers 674 and 675 that are configured to pierce (as described above with reference to device 600), device 700 includes barriers 774 and 775 that can have any suitable shape, size, and / or configuration and, in some examples, can transition in any suitable manner. For example, barrier 774 can be configured and / or arranged to form a substantially fluid-tight seal with one or more interior surfaces of device 700 and one or more exterior surfaces of actuator 778. In this manner, barrier 774 can limit and / or substantially prevent bodily fluids from undesirably passing from fluid flow path 754 to other portions of device 700 (e.g., in a manner similar to that described above with reference to barrier 674).

[0150] 13 , when device 700 is in the first state, diaphragm 776 can be in a first state (e.g., uninverted, unactuated, and / or initial state). Similarly, actuator 778 coupled to diaphragm 776 and barrier 775 can be in a first or initial state. As described in detail above with reference to device 600, when barrier 775 is in the first state, flow path 713 (e.g., inlet flow path, etc.) of device 700 can be isolated from flow path 754 (e.g., outlet flow path, etc.). In other words, barrier 775 (e.g., a flow controller) can be configured to isolate flow path 713 from flow path 754. Thus, when negative pressure is generated within a portion of device 700 (e.g., in response to coupling a fluid collection device to the outlet of device 700), an initial volume of bodily fluid can flow into an isolation chamber (e.g., an isolated portion of device 700, an isolated flow path, an isolated reservoir or container, etc.) of device 700, as described in detail above with reference to device 600.

[0151] After an initial volume of bodily fluid is received in the isolation chamber, positioning of device 700 can cause diaphragm 776 to invert, actuate, move, and / or otherwise transition from a first state ( FIG. 13 ) to a second state ( FIG. 14 ). As detailed above, movement of the diaphragm can result in similar movement of actuator 778, which can then position, move, and / or transition into contact with barrier 775 within device 700. For example, as shown in FIG. 14 , actuator 778 can move barrier 775 in a substantially linear motion from a first position to a second position, which in turn can be a position where barrier 775 no longer isolates flow path 713 from flow path 754. Thus, a subsequent volume of bodily fluid substantially free of contaminants can flow through device 700 and into a fluid collection device coupled thereto. In this manner, device 700 may be substantially similar in at least form and / or function to device 600 and, therefore, will not be further detailed herein.

[0152] 15, a flow chart illustrating a method 10 for diverting an initial volume of bodily fluid to obtain a bodily fluid sample with reduced contamination using a fluid control device as described herein is shown, according to an embodiment. The fluid control device (also referred to herein as a "control device") may be similar to and / or substantially identical to any of the control devices 100, 200, 300, 400, 500, 600, and / or 700 described herein.

[0153] Method 10 includes, at 11, establishing fluid communication between a bodily fluid source and an inlet of a fluid control device. In some examples, for example, the bodily fluid source can be a fluid source within a patient's body. More specifically, in some examples, the bodily fluid source can be a vein and / or vasculature within a patient's body. As described above, the control device can be configured to couple to and / or include an inlet device, such as, for example, an intravenous catheter, a butterfly needle, and / or the like. In other embodiments, the inlet device can be any suitable coupler, port, etc. configured to fluidly couple to the bodily fluid source. Thus, the inlet device can be operated to establish fluid communication between the bodily fluid source and the fluid control device, as described in detail above.

[0154] Upon establishing fluid communication with the bodily fluid source, at 12, an initial volume of bodily fluid is transferred from the bodily fluid source to an isolation chamber included in the control device and / or defined by the control device when the control device is in a first state. In some embodiments, the control device or a portion thereof (e.g., isolation chamber, junction, actuator, flow controller, etc.) is in the first state and / or configuration prior to use. In this manner, establishing fluid communication with the bodily fluid source automatically establishes fluid communication with the isolation chamber. More specifically, in some embodiments, a flow control device, such as, for example, a valve, flow restrictor, selectively permeable member, and / or the like, can be placed in a first state and / or configuration such that at least a flow of gas can pass through and / or be transported therethrough.

[0155] As described in detail herein, the initial volume can be any suitable volume of bodily fluid. For example, in some instances, the initial volume can be as small as a single drop of bodily fluid (or a relatively small number of drops of bodily fluid). In other instances, the initial volume can be, for example, up to approximately 30 mL, 40 mL, 50 mL, or more. Furthermore, as detailed above with reference to certain embodiments, the initial volume can be based at least in part on and / or related to the amount of bodily fluid that can be contained and / or sequestered within the isolation chamber. In some instances, the initial amount can be based at least in part on and / or related to a desired amount of fluid sufficient to transition the control device from an initial or first state to a subsequent or second state using a negative pressure differential defined and / or generated by a negative pressure source coupled to the outlet of the fluid control device. In some instances, the initial amount can be based at least in part on and / or related to a desired amount of fluid sufficient to transition one or more flow controllers included in the fluid control device from its / their first state to its / their second state. For example, in some examples, one or more flow controllers can be actuated and / or transitioned by a pressure differential, a predetermined and / or desired fluid volume, fluid contact, the passage of a predetermined and / or desired time, and / or the like, as described herein. In some examples, the initial volume can be a volume that is sufficient to entrain and / or contain substantially all undesirable microorganisms, which can be removed, etc., when fluid communication between the bodily fluid source and the inlet device is established.

[0156] In 13, in response to an initial volume of bodily fluid being placed in the isolation chamber, the control device is transitioned (e.g., automatically, passively, or in response to actuation) from a first state to a second state to isolate the initial volume of bodily fluid in the isolation chamber. In some embodiments, for example, the initial volume of bodily fluid can fill the isolation chamber, thereby substantially preventing any additional volume of bodily fluid from entering and / or being contained within the isolation chamber. In such embodiments, the filled isolation chamber can, for example, form a fluid lock or the like that substantially prevents additional amounts of bodily fluid from entering the isolation chamber and / or substantially prevents bodily fluid from exiting the isolation chamber. In some embodiments, the isolation chamber can include a membrane or material that interacts with bodily fluid (e.g., a semi-permeable membrane, such as those described above with reference to control devices 100, 200, 300, 400, 500, 600, and / or 700). In some embodiments, the isolation chamber and / or device can include one or more flow controllers (e.g., diaphragms described with reference to control devices 500, 600, and / or 700 and / or any other suitable flow controllers) that can be activated using any suitable mechanism to draw, divert, and / or isolate bodily fluid. For example, such flow controllers can use changes in pressure differentials (e.g., pressure differentials that may occur when a portion of a flow path is sealed and / or closed from interacting with bodily fluid), as described with reference to control devices 500, 600, and / or 700, or can be user-activated or activated based on other variables such as time, gravity, etc.

[0157] In some examples, two or more of these mechanisms can be used in combination. For example, in some embodiments, diversion and / or isolation of bodily fluids can be performed using a passive mechanism (e.g., based on one or more pressure differentials and / or filling of the isolation chamber). In other embodiments, diversion and isolation of fluids can also result from one or more active methods, such as, for example, one or more actuators that operate with or without user intervention. In some embodiments, one or more user-mediated mechanisms, actuators, controllers, etc. can be included to provide additional control functionality, such as, for example, supervisory or safety override functions, that can be used in certain settings, such as, for example, during training of personnel on the use of the control device. In other embodiments, the isolation chamber can retain and / or isolate the initial volume of bodily fluid in any suitable manner, such as those described herein, and / or any suitable combination thereof.

[0158] Once the control device transitions to the second state (e.g., passively or through user intervention), a subsequent volume of bodily fluid is transferred from the bodily fluid source to a fluid collection device (e.g., any of those described herein) in fluid communication with the control device at 14. As detailed above, isolation of the initial volume of bodily fluid in the isolation chamber may be operable to isolate contaminants contained in the initial volume of bodily fluid in the isolation chamber. Thus, the subsequent volume of bodily fluid transferred to the fluid collection device is substantially free of contaminants.

[0159] Referring to FIG. 16 , a flowchart illustrating a method 20 for diverting an initial volume of bodily fluid to obtain a bodily fluid sample with reduced contamination using a fluid control device as described herein is shown, according to an embodiment. The fluid control device (also referred to herein as a “control device”) may be similar and / or substantially equivalent to any of the control devices 100, 200, 300, 400, 500, 600, and / or 700 described herein. In some embodiments, for example, the fluid control device may include an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be coupled to a fluid collection device. Further, the fluid control device may include an isolation portion in fluid communication with the inlet and a sampling portion in fluid communication with the outlet.

[0160] Method 20 includes, at 21, coupling a fluid collection device to an outlet of the fluid control device. The fluid collection device can be any of those described herein. For example, in some embodiments, the fluid collection device can be a vacuum container, a sample bottle, a syringe, and / or the like. Furthermore, coupling the fluid collection device to the outlet can create and / or generate a negative pressure differential within at least a portion of the fluid control device, as detailed above.

[0161] At 22, a first flow controller of the fluid control device transitions from a first state to a second state when a negative pressure differential within the fluid control device has a first magnitude. As described above, the first flow controller may be a valve, selectively permeable material, restricted flow path, and / or the like configured to isolate an isolation portion of the fluid control device from the outlet when in the first state, and to establish fluid communication between the isolation portion and the outlet when in the second state, as detailed above.

[0162] At 23, when the first flow controller is in the second state, an initial volume of bodily fluid is received from the inlet of the fluid control device into the isolation portion in response to the negative pressure differential. In some examples, for example, the inlet can be in fluid communication with a bodily fluid source, such as a bodily fluid source within the patient's body (e.g., veins and / or vasculature within the patient's body). In some embodiments, for example, the inlet can be coupled to an inlet device, such as, for example, an intravenous catheter, butterfly needle, and / or the like, which is in turn inserted into a portion of the patient. Thus, bodily fluid can flow from the bodily fluid source, through the inlet of the fluid control device, and into the isolation portion.

[0163] At 24, the first flow controller is transitioned from the second state to the third state in response to the isolation portion receiving an initial volume of bodily fluid. As described in detail herein, the initial volume can be any suitable volume, such as, for example, a small volume, such as one drop of bodily fluid (or a relatively small number of drops of bodily fluid), to a volume of, for example, 50.0 mL or more. In some examples, the initial volume can be based at least in part on and / or related to a desired amount of fluid sufficient to transition the first flow controller from the second state to the third state. In some examples, the initial volume can be a volume of bodily fluid transferred to the isolation portion until a negative pressure differential (e.g., between the first flow controller and the inlet) is substantially equilibrated, etc. In such examples, the first flow controller can automatically transition from the second state to the third state when a negative pressure differential operable to draw the initial volume of bodily fluid is substantially equilibrated. In some embodiments, the first flow controller can include a selectively permeable material capable of saturating at least a portion of the initial volume of bodily fluid to transition the first flow controller from the second state to the third state, for example, as detailed above. In this manner, the first flow controller can isolate the isolation portion from the outlet when in the third state.

[0164] When the first flow controller is in a third state, a negative pressure differential within a portion of the fluid control device may increase from a first magnitude to a second magnitude. At 25, when the negative pressure differential has a second magnitude, the second flow controller transitions from the first state to the second state. The second flow controller can be configured, for example, to isolate the sampling portion of the fluid control device from the inlet when in the first state and to establish fluid communication between the sampling portion and the inlet when in the second state. As described above with reference to certain embodiments, the second flow controller can be any suitable control device or mechanism, such as, for example, a valve, a selectively permeable material, a restrictive flow path, a dissolvable material, a frangible barrier, a movable barrier, and / or the like.

[0165] As described above, the pressure difference sufficient to transition the second flow controller from a first state (e.g., a no-flow state) to a second state (e.g., a flow state) is greater than the pressure difference sufficient to transition the first flow controller from the first state (e.g., a no-flow state) to the second state (e.g., a flow state). In this manner, the second flow controller can be configured to transition to the second state after the first flow controller transitions between its first, second, and third states. Thus, at 26, a subsequent volume of bodily fluid is transferred from the inlet to the fluid collection device via the sampling portion and the outlet. As detailed above, receiving the initial volume of bodily fluid within the isolation portion and isolating the isolation portion from the outlet can be operable to isolate any contaminants contained in the initial volume of bodily fluid within the isolation portion of the fluid control device. Thus, the subsequent volume of bodily fluid transferred to the fluid collection device is reduced in contaminants and / or substantially free of contaminants.

[0166] 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. While the above-described schematic diagrams and / or embodiments show particular components arranged in particular orientations or positions, the arrangement of the components may be changed. While embodiments have been particularly shown and described, it will be understood that various changes in form and detail may be made. For example, while control devices 100, 200, 300, 400, 500, 600, and / or 700 have been described as transferring bodily fluid into the device as a result of negative pressure within a fluid collection device, in other embodiments, the devices described herein may be used with any suitable device configured to establish a pressure differential (e.g., a negative pressure differential). For example, in some embodiments, the outlet of the control device may be coupled to a syringe or a pump. In other embodiments, the control device may include a pre-filled isolation chamber, a vented isolation chamber, a vented isolation chamber, a manually actuated device configured to generate negative pressure, an energy source, and / or any other suitable means for defining and / or creating a pressure differential within a portion of the control device.

[0167] In some other embodiments, the negative pressure source can be associated with the fluid collection device, but can be unrelated. For example, a negative pressure source, such as a syringe, pump, or a passive source such as a gravity-assisted or structurally-assisted container, can be disposed downstream of the outlet of the fluid control device such that the applied negative pressure is transmitted to the fluid collection device and the outlet. For example, the negative pressure source may be in fluid communication with the outlet through the fluid collection device. In other embodiments, under some circumstances, the negative pressure source may be disposed in fluid communication with the outlet to apply a pressure differential, which may then be disposed in fluid communication with a collection device, as described in further detail herein, to collect the fluid drawn by the applied pressure differential.

[0168] In some embodiments, any fluid control device described herein can be formed from any suitable components that can be manufactured, sterilized, and packaged as separate parts or components. In such embodiments, a user can, for example, open one or more packages containing one or more components, assemble the components to form the fluid control device, and use the fluid control device described above. In other embodiments, any fluid control device described herein can be formed from any suitable components that can be manufactured, sterilized, assembled, and packaged as an assembly or integrated device. In such embodiments, a user can, for example, open a package containing such an assembly or integrated device and use the device described above without further assembly of the components. In some embodiments, any control device can be formed entirely or at least partially monolithically.

[0169] In some embodiments, any of the control devices can be physically and / or fluidly coupled to a collection device (e.g., a sample reservoir, syringe, blood culture bottle, collection vial, fluid transfer container, and / or any other suitable reservoir, collection device, and / or transfer device) by a user before or during use, as described in detail above. In other embodiments, any control device can be physically coupled, attached, formed, and / or otherwise joined to a fluid collection device during the manufacturing process. This can be done prior to sterilization, so that the collection path(s) and connection interface(s) (e.g., if the control device couples to a fluid collection device) maintain a closed system, mechanical flow diversion device within a sterile environment, immune to touchpoint contamination from external sources.

[0170] In some embodiments, pre-assembly of the control device and collection device can be such that a user is initially forced to segregate, isolate, and / or isolate at least a portion of an initial bodily fluid volume or flow before transferring a sample volume to the pre-assembled fluid collection device. For example, the control device can include an actuator configured to isolate an outlet from other portions of the control device, thereby isolating the collection device from such portions of the control device. Furthermore, after transferring the initial volume of bodily fluid, actuation of the actuator can result in isolation of the initial volume of bodily fluid and fluid coupling of the outlet to an additional portion (e.g., an inlet) of the control device. In some embodiments, pre-assembling the control device and collection device (e.g., during manufacturing) can enforce compliance with a sample acquisition protocol that, for example, requires isolation of an initial volume of bodily fluid before collecting a sample volume of bodily fluid.

[0171] In some embodiments, coupling, mating, and / or attachment (e.g., during manufacturing) of the fluid control device to the fluid collection device can be performed such that the control device can be removed after use (physically decoupled, removed with a specific "key," and / or other approaches used to separate the control device from the fluid collection device) to allow access to the fluid collection device. After decoupling, the collection device can be placed in an incubator and / or any other type of analytical machine, accessed for analysis, and / or otherwise further processed. In some embodiments, such decoupling can be blocked, restricted, and / or substantially prevented before use, and unblocked or enabled after use. In other embodiments, the fluid control device and fluid collection device can be (at least partially) permanently coupled and / or monolithically formed to prevent such decoupling.

[0172] Any of the embodiments described herein may be used in combination with any suitable fluid transfer, fluid collection, and / or fluid storage device, such as, for example, the fluid reservoir described in the '420 patent, the transfer device described in the '510 publication, and / or the transfer adapter described in the '352 publication. In some embodiments, any of the embodiments described herein may be implemented using techniques disclosed in, for example, U.S. Patent No. 8,535,241, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed October 12, 2012; U.S. Patent No. 9,060,724, entitled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed May 29, 2013; U.S. Patent No. 9,155,495, entitled "Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed December 2, 2013; U.S. Patent Publication No. 2016 / 0361006, entitled "Devices and Methods for Syringe-Based Fluid Transfer for Bodily-Fluid Sampling," filed June 13, 2016; U.S. Patent Publication No. 2016 / 0361006, entitled "Devices and Methods for Syringe-Based Fluid Transfer for Bodily-Fluid Sampling," filed November 20, 2017; The present invention may be used in combination with fluid transfer, fluid collection, and / or fluid storage devices such as those described in U.S. Patent Publication No. 2018 / 0140240, entitled "Apparatus and Methods for Maintaining Sterility of a Specimen Container," filed September 6, 2016, and / or U.S. Patent Publication No. 2017 / 0065733, entitled "Apparatus and Methods for Maintaining Sterility of a Specimen Container," filed September 6, 2016, the disclosures of each of which are incorporated herein by reference in their entireties.

[0173] Although some of the embodiments described above include a flow controller that selectively establishes fluid communication between the isolation chamber and a fluid collection device (or other negative pressure source), the control device can be configured to transfer a flow of bodily fluid in response to a negative pressure differential arising from any appropriate portion(s) of the device. For example, while the control device 200 is described above as including a flow controller (e.g., membrane 215, and / or the like) that selectively places the isolation chamber 214 in fluid communication with a fluid collection device (e.g., a sample reservoir or syringe) until the membrane 215 transitions to a sealing or closed state (e.g., until the membrane 215 is sufficiently wetted), in other embodiments, the control device can include an isolation chamber that is a pre-sealed, evacuated, and / or pre-filled chamber, whereby establishing fluid communication between the inlet and the isolation chamber can create a negative pressure differential sufficient to draw an initial volume of bodily fluid into the isolation chamber. In such embodiments, the control device can be configured to transfer bodily fluid into the isolation chamber until the pressure differential is sufficiently reduced and / or otherwise substantially uniform. Further, in some such embodiments, the isolation chamber and / or inlet may include a coupler, an actuator, a needle, a septum, a port, and / or any other suitable member capable of establishing fluid communication therebetween (e.g., capable of transitioning the isolation chamber from a sealed configuration to an unsealed configuration).

[0174] Although embodiments are described above as including particular means for adjusting and / or controlling the amount of negative pressure applied to or through at least a portion of the device(s), in other embodiments, the control device may include any suitable functions, mechanisms, and / or devices configured to adjust, create, 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 manually adjust and / or otherwise control the amount or magnitude of negative pressure within one or more portions of the control device by shifting and / or moving actuators to change (e.g., decrease or increase) the size of one or more portions of a fluid flow path or fluid flow interface within a portion of the control device.

[0175] As another example, any of the embodiments described herein can include any suitable actuator and / or flow controller configured to selectively control fluid flow through at least a portion of the device. Specifically, the flow controller or the like can be one or more of a selectively permeable material or membrane, a valve, a diaphragm, and / or any other suitable flow controller. While some of the embodiments have been described as including an actuator rod configured to transition from a first configuration or position to a second configuration or position, in other embodiments, any of the actuators described herein can include an actuator rod configured to transition between a first position and a second position to at least temporarily isolate the outlet of the device from one or more other portions of the device. In some embodiments, such actuators can be configured for use with a given and / or predetermined collection device, such as a syringe. In other embodiments, such actuators can be used with any suitable collection device.

[0176] While embodiments are described above as including or coupled to an inlet device, such as a needle, configured to pierce a patient's skin and place the needle lumen in fluid communication with the patient's vein, in other embodiments, the fluid control device can include and / or be coupled to any suitable inlet device. For example, in some embodiments, the inlet device can include a trocar or the like and a catheter. The trocar is configured to pierce a patient's skin and then be withdrawn from the patient, leaving the inlet device's catheter in place within the patient. In other embodiments, the inlet device need not pierce the patient's skin. For example, in some embodiments, the inlet device can include a needle or catheter that can be placed in a dish, well, sample volume, container, reservoir, etc. In still other embodiments, the inlet device is and / or can include a coupler or port configured to couple to an indwelling needle or intravenous catheter. In other embodiments, such a coupler or port can be configured to couple to any suitable source of bodily fluid (or a port thereof), such as, for example, a syringe, reservoir, container, etc.

[0177] Thus, although embodiments have been described for withdrawing and isolating an initial volume of bodily fluid to isolate contaminants, such as microorganisms present on the skin, in other embodiments, the inlet device can be coupled to any suitable bodily fluid source, and the control device can be configured to isolate the initial volume of bodily fluid withdrawn from that bodily fluid source to isolate contaminants that may be present within the source containing the bodily fluid and / or any interface of the container or reservoir. For example, in some embodiments, the needle of the inlet device can be configured to pierce a port or surface of the container or reservoir to place the needle in fluid communication with the interior volume of the device. In such embodiments, the devices described herein can be used to isolate an initial volume of bodily fluid from the bodily fluid source, and then isolate contaminants or the like that may be present at the pierced interface, port, or surface. Thus, the devices and methods described herein can be used to obtain reduced-contamination bodily fluid samples from any suitable bodily fluid source. Additionally, although some such contaminants are described herein as microorganisms present on the skin, it should be understood that the contaminant may be, for example, any contaminant that is or includes any component (e.g., microorganism, virus, molecule, particle, element, etc.) that is present outside the source of the bodily fluid and / or is otherwise foreign to the bodily fluid.

[0178] Although various embodiments have been described as having particular combinations of features, concepts, and / or components, other embodiments can have any combination or subcombination of any features, concepts, and / or components from any of the embodiments described herein. For example, as described above, device 700 includes concepts, features, and / or elements of device 600, which includes concepts, features, and / or elements of device 500, and device 400 includes concepts, features, and / or elements of devices 200 and 300. The specific configuration of the various components can also be varied. For example, the size and specific shape of the various components can differ from the embodiments shown while still providing the functionality described herein. More specifically, the size and shape of the various components can be specifically selected for the desired rate and / or volume of bodily fluid flow into the fluid reservoir. Similarly, the size and / or shape of the various components can be specifically selected for a desired or intended use. Thus, it should be understood that the size, shape, and / or arrangement of an embodiment and / or its components can be adapted for a given application unless the context clearly dictates otherwise.

[0179] In some embodiments, the specific configuration of the various components can also be varied. For example, the size and specific shape of the various components can differ from the illustrated embodiments while still providing the functionality described herein. More specifically, the size and shape of the various components can be specifically selected for a desired rate and / or volume of bodily fluid flow into the fluid reservoir. Similarly, the size and / or shape of the various components can be specifically selected for a desired or intended use. For example, in some embodiments, a device as described herein can be configured for use with or on an apparently healthy adult patient. In such embodiments, the device can include an isolation chamber having a first volume (e.g., about 0.5 ml to about 5.0 ml). In other embodiments, a device as described herein can be configured for use with or on, for example, a very sick patient and / or pediatric patient. In such embodiments, the device can include an isolation chamber having a second volume that is less than the first volume (e.g., less than about 0.5 ml). Thus, it should be understood that the size, shape, and / or arrangement of an embodiment and / or its components can be adapted for a given application unless the context clearly dictates otherwise.

[0180] Although not shown, any of the devices described herein can include an opening, port, coupler, septum, luer lock, gasket, valve, threaded connector, standard fluid interface, etc. (referred to as a "port" for simplicity) in fluid communication with the isolation chamber. In some such embodiments, the port can be configured to couple to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the port can be configured to couple to a reservoir, which can then allow a larger volume of bodily fluid to be diverted and / or transferred to the isolation chamber. In other embodiments, the port can be coupled to a negative pressure source, such as a vacuum container, pump, syringe, and / or the like, to collect a portion or the entire volume of bodily fluid in the isolation chamber, channel, reservoir, etc. and use that volume of bodily fluid (e.g., a pre-sample volume) for additional clinical and / or in vitro diagnostic testing purposes. In 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 and / or bodily fluid source (e.g., in the case of pediatric patients, very ill patients, patients with low blood volume, and / or the like).

[0181] In some embodiments, the port can be configured to accept a probe, sampling tool, testing device, and / or the like that can be used to perform one or more tests (e.g., tests that are not sensitive to potential contamination) on the initial volume while the initial volume is placed or isolated in the isolation chamber. In other embodiments, the isolation channel, chamber, and / or reservoir can be configured with additional diagnostic testing components (e.g., paper tests) incorporated into the chamber so that the initial body fluid is used for that testing. In still other embodiments, the isolation chamber, channel, and / or reservoir can be designed, sized, and configured to be removable, compatible with testing devices, and / or specifically usable for other types of body fluid testing commonly performed on patients with suspected conditions. As an example, patients suspected of sepsis typically have blood samples taken for lactate testing, procalcitonin testing, and blood culture testing. All of the fluid control devices described herein can be configured such that the isolation chamber, channel, reservoir, 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 next isolation sample is collected for microbiological testing.

[0182] 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, such that an initial amount or volume of bodily fluid can flow from an inlet through a lumen, canal, flow path, etc., bypassing the isolation chamber and into the collection device. In some embodiments, the fluid control device can include, for example, an actuator having at least three states. First, bodily fluid can flow from the inlet to the isolation chamber; second, bodily fluid can flow from the inlet to the outlet after an initial volume has been isolated in the isolation chamber; and third, 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 reference to certain embodiments, and can include a second actuator configured to transition the device to a bypass configuration, or the like. 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.

[0183] In some embodiments, a method of using a fluid control device using an external negative pressure source can include the ordered steps of establishing fluid communication between a bodily fluid source (e.g., a patient's vein or the like) and an inlet of the fluid control device. The outlet of the fluid control device is then placed in fluid communication with and / or otherwise engaged with the negative pressure source. Such a negative pressure source can be a sample reservoir, a syringe, a vacuum container, an intermediate transfer device, and / or the like. The fluid control device can be in a first state or mode of operation when the outlet is coupled to the negative pressure source such that a negative pressure differential is applied across at least a portion of the fluid control device, which can be operable to draw an initial volume of bodily fluid into an isolation chamber of the fluid control device. Once the initial volume of bodily fluid is placed in the isolation chamber, the fluid control device is transitioned from the first state or mode of operation to a second state or mode of operation, either automatically or through user intervention, 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 can be such that contaminants entrained in the initial volume of flow are similarly isolated within the isolation chamber. With the initial volume of bodily fluid isolated within the isolation chamber, and fluid communication established between the inlet and outlet, a subsequent volume of substantially uncontaminated bodily fluid can be collected in one or more sample reservoirs.

[0184] Although the methods using the fluid control devices are explicitly described as including enumerated, ordered steps, in other embodiments, the ordering of specific events and / or procedures in any of the methods or processes described herein may be altered, and such alterations are in accordance with variations of the invention. Additionally, certain events and / or procedures may be performed simultaneously in a parallel process where possible, or may be performed sequentially as described above. Certain steps may be partially completed or omitted before proceeding to a subsequent step.

[0185] For example, while the devices are described herein as transitioning from a first state to a second state in a discrete operation or the like, it should be understood that the devices described herein can be configured to transition from the first state to the second state automatically and / or passively, and that such transition can occur over a period of time. In other words, the transition from the first state to the second state can, in some instances, be relatively gradual, such that the housing begins to transition from the first state to the second state as the final portion of the initial volume of bodily fluid is being transferred into the isolation chamber. In some instances, the rate of change when transitioning from the first state to the second state can be selectively controlled to achieve one or more desired characteristics associated with the transition. Furthermore, in some such instances, the inflow of the final portion of the initial volume can limit and / or substantially prevent bodily fluid already disposed in the isolation chamber from escaping therefrom. Thus, while the transition from the first state to the second state can occur over a given period of time, the isolation chamber can nonetheless isolate the volume of bodily fluid disposed therein.

Claims

1. an inlet configured to be placed in fluid communication with a source of bodily fluid; an outlet configured to be placed in fluid communication with a fluid collection device, wherein a negative pressure differential is created between the outlet and the inlet when the outlet is placed in fluid communication with the fluid collection device; an isolation portion in fluid communication with the inlet, the isolation portion including a first flow controller configured to transition from a first state in which the isolation portion is isolated from the outlet to a second state in which the isolation portion is in fluid communication with the outlet when the negative pressure differential has a first magnitude; a sampling portion in fluid communication with the outlet, the sampling portion including a second flow controller configured to transition from a first state in which the sampling portion is isolated from the inlet to a second state in which the sampling portion is in fluid communication with the inlet when the negative pressure differential has a second magnitude greater than the first magnitude; A fluid control device comprising:

2. the fluid collection device is a sample bottle; 10. The system of claim 1, wherein the sample bottle is at least partially evacuated, whereby the negative pressure differential is created by coupling the outlet to the sample bottle.

3. the fluid collection device is a syringe; The system of claim 1 , wherein the syringe is configured to be manipulated to create the negative pressure differential after the outlet is coupled to the syringe.

4. The system of claim 1 , wherein the first flow controller is configured to automatically transition from the first state to the second state.

5. The system of claim 1 , wherein the second flow controller is configured to automatically transition from the first state to the second state.

6. 2. The system of claim 1, wherein the isolation portion is configured to receive an initial volume of bodily fluid drawn from the bodily fluid source in response to the first flow controller transitioning to the second state.

7. the first flow controller has a third state in which the isolation portion is isolated from the outlet; 7. The system of claim 6, wherein the first flow controller is configured to transition from the second state to the third state as a result of the isolation portion receiving the initial volume of bodily fluid.

8. 8. The system of claim 7, wherein the first flow controller, when placed in the third state, causes an increase in the magnitude of the negative pressure differential within the sampling portion from the first magnitude to the second magnitude.

9. the first flow controller comprises a selectively permeable material; 8. The system of claim 7, wherein the selectively permeable material is configured to (1) permit the flow of gases and prevent the flow of bodily fluids through the selectively permeable material when in a first state, and (2) prevent the flow of gases and bodily fluids through the selectively permeable material when in a second state.

10. 10. The system of claim 9, wherein the selectively permeable material is configured to transition from the first state to the second state as a result of the initial volume of bodily fluid being received in the isolation portion, thereby placing the first flow controller in the third state.

11. a housing having an inlet configured to establish fluid communication with a source of bodily fluid and an outlet configured to be coupled to a fluid collection device, wherein the coupling of the outlet to the fluid collection device creates a negative pressure differential within at least a portion of the housing, the housing defining an isolation flow path in fluid communication with the inlet and a sampling flow path in fluid communication with the outlet; a first flow controller having a flow state in which fluid communication is established between the isolated flow path and the outlet, and a no-flow state in which the isolated flow path is isolated from the outlet; a second flow controller having a flow state in which fluid communication is established between the sampling channel and the inlet and a no-flow state in which the sampling channel is isolated from the inlet; the first flow controller is configured to be in the flow state such that an initial volume of bodily fluid flows through the isolated flow path toward the first flow controller when the negative pressure differential created by coupling the outlet to the fluid collection device has a first magnitude; the first flow controller is configured to transition to the no-flow state when the initial volume of bodily fluid is received in the isolated flow path such that (1) the isolated flow path is isolated from the outlet, and (2) the negative pressure differential is increased to a second magnitude operable to transition the second flow controller from the no-flow state to the flow state.

12. the fluid collection device is a sample bottle; 12. The system of claim 11, wherein the sample bottle is at least partially evacuated, whereby the negative pressure differential is created by coupling the outlet to the sample bottle.

13. the fluid collection device is a syringe; The system of claim 11 , wherein the syringe is configured to be manipulated to create the negative pressure differential after the outlet is coupled to the syringe.

14. The system of claim 11 , wherein the first flow controller is configured to automatically transition from the first state to the second state.

15. The system of claim 11 , wherein the second flow controller is configured to automatically transition from the first state to the second state.

16. 12. The system of claim 11, wherein the first flow controller is at least one of a valve, a selectively permeable material, or a restricted flow path.

17. 17. The system of claim 16, wherein the second flow controller is at least one of a valve, a selectively permeable material, a dissolvable material, a frangible barrier, a movable barrier, or a restricted flow path.

18. the first flow controller comprises a selectively permeable material; 12. The system of claim 11, wherein the selectively permeable material is configured to (1) permit the flow of gases and prevent the flow of bodily fluids through the selectively permeable material when in a first state, and (2) prevent the flow of gases and bodily fluids through the selectively permeable material when in a second state.

19. 20. The system of claim 18, wherein the selectively permeable material is configured to transition from the first state to the second state as a result of the isolation flow path receiving the initial volume of bodily fluid, and wherein the transition of the selectively permeable material from the first state to the second state places the first flow controller in the no-flow state.

20. the first state of the selectively permeable material is an unsaturated state; 20. The system of claim 19, wherein the second state of the selectively permeable material is a saturated state.

21. 1. A method of using a fluid control device to obtain a body fluid sample with reduced contamination, comprising: coupling a fluid collection device to an outlet of the fluid control device, the coupling of the fluid collection device to the outlet configured to create a negative pressure differential within at least a portion of the fluid control device; transitioning a first flow controller from a first state to a second state when the negative pressure differential has a first magnitude, wherein the first flow controller isolates an isolation portion of the fluid control device from the outlet when in the first state and establishes fluid communication between the isolation portion and the outlet when in the second state; receiving an initial volume of body fluid from the inlet of the fluid control device into the isolation portion in response to the negative pressure differential when the first flow controller is in the second state; transitioning the first flow controller from the second state to a third state in response to said receiving, wherein the first flow controller isolates the isolation portion from the outlet when in the third state, and the negative pressure differential increases from the first magnitude to a second magnitude when the first flow controller is in the third state; transitioning a second flow controller from a first state to a second state when the negative pressure differential has the second magnitude, wherein the second flow controller isolates a sampling portion of the fluid control device from the inlet when in the first state and establishes fluid communication between the sampling portion and the inlet when in the second state; and transferring a subsequent volume of bodily fluid from the inlet to the fluid collection device via the sampling portion and the outlet.

22. 22. The method of claim 21 , wherein the transitioning of the first flow controller from the first state to the second state comprises automatically transitioning the first flow controller from the first state to the second state without manual intervention.

23. 23. The method of claim 22, wherein the transitioning of the first flow controller from the second state to the third state comprises automatically transitioning the first flow controller from the first state to the second state without manual intervention.

24. 22. The method of claim 21 , wherein the transitioning of the second flow controller from the first state to the second state comprises automatically transitioning the second flow controller from the first state to the second state without manual intervention.

25. the first flow controller comprises a selectively permeable material; the selectively permeable material is configured to (1) permit the flow of gases and prevent the flow of bodily fluids through the selectively permeable material when in a first state, and (2) prevent the flow of gases and bodily fluids through the selectively permeable material when in a second state; 22. The method of claim 21, wherein the transition of the first flow controller from the second state to the third state comprises the selectively permeable material being placed in its second state.

26. establishing fluid communication between the inlet and a source of bodily fluid; 22. The method of claim 21, wherein the initial volume of bodily fluid includes a contaminant associated with the establishment of fluid communication between the inlet and the bodily fluid source.

27. 27. The method of claim 26, wherein when the first flow controller is in the third state, the initial volume of bodily fluid and the contaminant are isolated within the isolation portion such that the subsequent volume of bodily fluid is substantially free of the contaminant.

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