Fluid control device and method of using the same

Abstract

To provide a device for procuring bodily fluid samples with reduced contaminants such as dermally residing microbes and / or other contaminants exterior to a bodily fluid source.SOLUTION: A fluid control device includes an inlet configured to be arranged in fluid communication with a bodily fluid source and an outlet configured to be arranged in fluid communication with a fluid collection device. The fluid control device has a sequestration portion that can be vented or evacuated. The fluid control device has a first state in which an initial volume of bodily fluid can flow from the inlet to the sequestration portion and a second state in which (1) the initial volume is sequestered in the sequestration portion, and (2) a subsequent volume of bodily fluid, being substantially free of contaminants, can flow through at least a part of the fluid control device and into the fluid collection device. The fluid control device can transition automatically or in response to an actuation of a part of the fluid control device after the sequestration portion receives the initial volume.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 595,871, entitled "Fluid Control Devices and Methods of Using the Same", filed on December 7, 2017, the disclosure of which is hereby incorporated by reference in its entirety.

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 687,951, entitled "Fluid Control Devices and Methods of Using the Same", filed on June 21, 2018, the disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0003] The present invention generally relates to the parenteral procurement of body fluid samples, and more specifically to devices and methods for procuring body fluid samples with reduced contaminants, such as fluid diversion, isolation, and / or isolation devices, and microorganisms present on the skin and / or other contaminants external to the body fluid source.

[0004] Healthcare practitioners routinely perform a variety of types of microbial and other extensive diagnostic tests on patients using parenterally obtained body fluids. As advanced diagnostic techniques evolve and improve, the speed, accuracy (both sensitivity and specificity), and value of the information available to clinicians continue to increase. Maintaining the integrity of body fluid samples during and / or after collection also ensures that the analytical diagnostic results represent the patient's in vivo state. Examples of diagnostic techniques that rely on high-quality, non-contaminated, and / or pure body 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 the like. When biological materials and / or other external contaminants, which can include cells outside the intended source for sample procurement, are inadvertently included in the body fluid sample being analyzed, inaccurate test results can be derived. In short, when the purity of a sample intended to be derived or collected from a specific body fluid source is compromised during the sample procurement process, the resulting analytical test results are inaccurate, distorted, spurious, false positive, false negative, and / or otherwise do not represent the patient's actual state, which can then lead to poor, inaccurate, confusing, uncertain, less reliable, and / or other undesirable clinical decision-making regarding the patient's condition.

[0005] In some embodiments, patient samples (e.g., body fluids) are examined for the presence of one or more potentially undesirable microorganisms such as bacteria, fungi, or yeast (e.g., Candida). In some embodiments, the microorganism examination may include culturing the patient's sample in one or more sterile and / or non-sterile containers that may contain a culture medium, common additives, and / or other types of solutions that promote the growth of microorganisms. In other embodiments, the sample in the container may be analyzed directly (i.e., not cultured) and may not contain a culture medium or additives associated with culturing the specimen. In yet other embodiments, various techniques can be used to assist in the detection of the presence of microorganisms, as well as other types of biological materials, certain types of cells, biomarkers, proteins, antigens, enzymes, blood components, and / or the like during a diagnostic test. Examples include 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, morphological cell analysis, and / or other general or advanced and sophisticated techniques utilized in a clinical testing environment to characterize the patient specimen and / or to detect, identify, type, classify, and / or characterize certain organisms, antibiotic sensitivities, and / or the like, but are not limited to these.

[0006] In some examples, the detection of the presence of microorganisms includes enabling the microorganisms and / or organisms to grow for a period of time (e.g., various times ranging from less than 1 hour to several hours, days, longer or shorter depending on the diagnostic technique used). Thereafter, the growth of the microorganisms and / or organisms can be detected by automated continuous monitoring and / or by other methods specific to the analysis platforms and techniques used for detection, identification, and / or the like.

[0007] In a culture test, for example, when a microorganism is present in a patient's sample, the microorganism multiplies over time in a culture medium, and in some cases, carbon dioxide produced by the growth of the organism can be detected by an automated monitoring technique. The presence of the microorganism in the culture medium (indicated by observation of carbon dioxide and / or other detection methods) suggests the presence of an equivalent microorganism in the patient sample, and in turn, the presence of an equivalent microorganism in the body fluid of the patient from whom the sample was obtained. Thus, when it is determined that a microorganism is present in the culture medium (or, more generally, in the sample used for the test), the patient can be diagnosed and prescribed one or more antibiotics or other treatments specifically designed to treat or otherwise remove the unwanted microorganism from the patient.

[0008] However, patient samples can be contaminated during procurement and / or may yield false-negative results. For example, microorganisms from the body surface (e.g., microorganisms that are resident on the skin), which can be removed directly or indirectly through tissue fragments, hair follicles, sweat glands, and other skin appendage structures during the specimen procurement process (which can include specimen procurement via insertion of a needle into the patient, a peripheral intravenous catheter (PIV), a peripherally inserted central catheter (PICC), and / or other indwelling catheter(s) such as lumen-containing devices, syringe or other suitable means used to collect the patient specimen), can be included in and continuously transferred with the patient's sample to a culture medium, test vial, or other suitable specimen collection or transfer container and analyzed in a non-culture-based assay. Another potential source of contamination can be from the person drawing the patient sample (e.g., physician, phlebotomist, nurse, technician, etc.). Specifically, the equipment, consumables, and / or devices used during the patient sample procurement process often include multiple fluid interfaces (by way of example and not limitation, patient to needle, needle to transfer adapter, transfer adapter to sample container, catheter hub to syringe, syringe to transfer adapter, needle / tube to sample container, and / or other fluid interfaces, or any combination thereof) that can each introduce potential contamination points. In some embodiments, such contaminants can thrive in the culture medium and / or be identified by another non-culture-based diagnostic technique, ultimately resulting in false positive and / or false negative microorganism test results that can inaccurately reflect the presence or absence of such microorganisms in the patient (i.e., in vivo).

[0009] Such inaccurate results due to contamination and / or other causes of admixture that compromise the purity of the sample are of concern when attempting to diagnose or treat a suspected wide range of illnesses, diseases, infections, patient conditions, or other suspected ailments. For example, false-negative results from a microbiological test can lead to misdiagnosis of a patient's illness and / or delay in treatment, and in some cases, can lead to the patient's death. Conversely, false-positive results from a microbiological test can not only cause serious side effects, including death, to the patient, but can also result in unnecessary burden and cost to the healthcare system due to prolonged patient stays and / or other complications associated with incorrect treatment, resulting in the patient receiving one or more antimicrobial therapies unnecessarily. The use of imaging diagnostic devices due to these false-positive results is also a concern from both a cost and patient safety perspective, as the unnecessary exposure to concentrated radiation associated with various imaging procedures (such as CT scans) can have many known adverse effects on the long-term health of the patient. In some examples, devices and / or systems can be used to reduce the likelihood of contamination, tampering, and / or the like of a body fluid sample for testing. For example, some known devices can be configured to collect, divert, separate, and / or isolate or sequester an initial volume of body fluid that is likely to contain contaminants such as microorganisms present in the dermis or the like. However, such devices are recognized as being cumbersome, unintuitive, and difficult to use, and can be inappropriate or unusable as intended for the targeted patient population, etc. Further, such devices can require training, user observation, intervention by more than one user, and / or can present challenges that can lead to limitations in effectiveness based on variables including, but not limited to, the environment, education, clinician skill, patient condition, and / or the like. In some embodiments, such challenges can complicate the collection of consistently high-quality samples, such as uncontaminated, sterile, pure samples, which can then affect the validity of the test results.

[0010] In some examples, devices and / or systems can be used to reduce the likelihood of contamination, tampering, and / or the like of a body fluid sample for testing. For example, some known devices can be configured to collect, divert, separate, and / or isolate or sequester an initial volume of body fluid that is likely to contain contaminants such as microorganisms present in the dermis or the like. However, such devices are recognized as being cumbersome, unintuitive, and difficult to use, and can be inappropriate or unusable as intended for the targeted patient population, etc. Further, such devices can require training, user observation, intervention by more than one user, and / or can present challenges that can lead to limitations in effectiveness based on variables including, but not limited to, the environment, education, clinician skill, patient condition, and / or the like. In some embodiments, such challenges can complicate the collection of consistently high-quality samples, such as uncontaminated, sterile, pure samples, which can then affect the validity of the test results.

[0011] Accordingly, there is a need for a fluid diversion device and method for obtaining a body fluid sample with reduced contaminants such as microorganisms present on the skin external to the body fluid source and / or other contaminants. Further, a device is needed that is user-friendly, requires little or no user intervention and / or actuation, demonstrates consistent effectiveness, and addresses the challenges associated with collecting samples from patients with physical characteristics that affect their ability to collect samples in difficult health situations and / or body fluid samples. SUMMARY OF THE INVENTION

[0012] Devices and methods for obtaining a body fluid sample with reduced contaminants such as microorganisms present on the skin and / or other contaminants external to the body fluid source are described herein. In some embodiments, the device includes a housing and an actuator. The housing has an inlet configured to be disposed in fluid communication with the body fluid source, an outlet configured to be disposed in fluid communication with a fluid collection device, and a separation portion configured to receive an initial volume of the body fluid. The actuator defines at least one fluid flow path configured to direct a flow of the body fluid through at least a portion of the housing. The actuator is configured in a first state to establish fluid communication between the separation portion and the outlet through the at least one fluid flow path. The outlet is configured to transition from a closed state to an open state when the actuator is in the first state to vent the separation portion through the at least one fluid flow path and the outlet. After venting the separation portion, the actuator is configured to transition from the first state to a second state such that the at least one fluid flow path establishes fluid communication between the separation portion and the inlet to enable transfer of the initial volume of the body fluid to the separation portion. After the initial volume of the body fluid has been transferred into the separation portion, the actuator is configured to transition from the second state to a third state such that (1) the initial volume of the body fluid is isolated within the separation portion and (2) when the fluid collection device is coupled to the outlet and the outlet is in the open state, the outlet is disposed in fluid communication with the inlet through the at least one fluid flow path to enable transfer of a subsequent volume of the body fluid to the fluid collection device.

Brief Description of the Drawings

[0013]

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[0014] Devices and methods for collecting, diverting, guiding, isolating, sequestering, etc., an initial volume of body fluid and then reducing contamination in the procured body fluid sample are described herein. Any of the fluid control devices described herein can be configured to receive, procure, and / or transfer a body fluid flow, bolus, volume, etc. A first reservoir, channel, flow path, or portion of the device can receive an initial amount of body fluid flow and then be substantially or completely isolated within or by the first reservoir or first portion of the device (e.g., contained, held, routed, sequestered, isolated, vapor locked, separated, and / or the like). In some embodiments, contaminants such as microorganisms present in the dermis or the like are included in and / or admixed with the initial amount of body fluid and are likewise isolated within or by the first reservoir or first portion of the device. Once the initial amount is isolated, subsequent body fluid flow can be diverted, channeled, guided, flow controlled (e.g., manually, automatically, and / or semi-automatically) to a second reservoir, second portion of the device, and / or any additional flow path(s). Thus, once the initial amount is isolated, additional and / or subsequent amount(s) of body fluid flow are substantially freed from contaminants that could otherwise produce inaccurate, skewed, spurious, false positive, false negative, false results and some diagnostics and / or tests are performed. In some embodiments, the initial amount of body fluid can also be used in other tests such as those that are less affected by the presence of contaminants, discarded as waste volume, infused back into the patient, and / or used in other appropriate clinical applications.

[0015] In some embodiments, the features of the fluid control device and / or method described herein are to (1) overcome the physical patient challenges that can limit and / or prevent a sufficient pressure differential (e.g., the difference between blood pressure and ambient air pressure) to fully engage the isolation and / or diversion portion and / or divert the flow of fluid to the fluid collection device, (2) appropriately fill the isolation and / or diversion portion with a clinically verified and / or desirable amount of body fluid, (3) provide efficiency, timeliness, and / or user-acceptable consistency in the body fluid collection process, and / or (4) provide means to manipulate and / or automatically divert the flow of fluid (e.g., movement of the physical components of the system, or alteration, switching, engagement, and / or adoption or achievement of the desired fluid dynamics in other ways) to enable isolation and / or separation of an initial sample and collection of subsequent samples, by using an external negative pressure source (e.g., provided by a fluid collection device or other suitable means).

[0016] In some embodiments, the device includes a housing and an actuator. The housing has an inlet configured to be disposed in fluid communication with a body fluid source, an outlet configured to be disposed in fluid communication with a fluid collection device, and a separation portion configured to receive an initial volume of the body fluid. The actuator defines at least one fluid flow path configured to direct a flow of the body fluid through at least a portion of the housing. The actuator is configured in a first state to establish fluid communication between the separation portion and the outlet via the at least one fluid flow path. The outlet is configured to transition from a closed state to an open state when the actuator is in the first state so as to vent the separation portion via the at least one fluid flow path and the outlet. After venting the separation portion, the actuator is configured to transition from the first state to a second state such that the at least one fluid flow path establishes fluid communication between the separation portion and the inlet to enable transfer of the initial volume of the body fluid to the separation portion. After the initial volume of the body fluid has been transferred into the separation portion, the actuator is configured to transition from the second state to a third state such that (1) the initial volume of the body fluid is isolated within the separation portion and (2) when the fluid collection device is coupled to the outlet and the outlet is in the open state, the outlet is disposed in fluid communication with the inlet via the at least one fluid flow path to enable transfer of a subsequent volume of the body fluid to the fluid collection device.

[0017] In some embodiments, the device includes an inlet member coupled to the housing, an outlet member coupled to the housing, and a separation portion at least partially formed by the housing. The inlet member defines a lumen in fluid communication with the fluid flow path defined by the housing and is configured to be disposed in fluid communication with a body fluid source. The outlet member defines a lumen in fluid communication with the fluid flow path defined by the housing and is configured to be disposed in fluid communication with a fluid collection device. The separation portion is in fluid communication with the fluid flow path defined by the housing and is configured to deform from a first state to a second state in response to a force exerted on a portion of the housing to vent the separation portion. The separation portion is configured to transition from the second state to the first state in response to removal of the force to generate a suction force within the separation portion to draw an initial volume of body fluid into the lumen of the inlet member and through the fluid flow path into the separation portion.

[0018] In some embodiments, a method of using a fluid control device to obtain a reduced contamination body fluid sample includes exerting a force that deforms a separation portion of the fluid control device and, as a result of the deformation of the separation portion, venting the separation portion. Fluid communication is established between the body fluid source and the inlet member of the fluid control device. The force exerted on the separation portion is removed to generate a suction force within the separation portion. In response to the suction force, an initial volume of body fluid is transferred from the body fluid source, through the inlet member, and into the separation portion. As a result of the initial volume of body fluid being disposed in the separation portion, a subsequent volume of body fluid is transferred from the body fluid source, through the inlet member, and to an outlet member that is in fluid communication with the inlet member.

[0019] In some embodiments, the fluid control device includes an inlet and an outlet. The inlet is configured to be in fluid communication with a body fluid source or an intermediate body fluid transfer device, and the outlet is configured to be in fluid communication with a fluid collection device (e.g., a sample bottle, container, reservoir, syringe, vacuum container, dish, vial, lumen-containing device, and / or any other suitable body fluid collection and / or transfer device). In some embodiments, the fluid control device has a first state in which an initial volume of body fluid can flow from the inlet into an isolation and / or diversion portion of the fluid control device (which can be formed by or within or coupled to the fluid control device), and a second state in which (1) the initial volume is isolated in the isolation and / or diversion portion of the fluid control device and (2) a subsequent volume of body fluid, substantially free of contaminants, can flow from the body fluid source through at least a portion of the fluid control device to the fluid collection device. The fluid control device is configured to transition automatically or in response to actuation of a portion of the fluid control device from the first state to the second state after the isolation and / or diversion portion has received the initial volume.

[0020] As used herein and in the claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "member" is intended to mean a single member or combination of members, and the term "material" is intended to mean one or more materials or combinations thereof.

[0021] As used herein, the terms "about," "approximately," and / or "substantially," when used in relation to a defined value and / or other geometric relationships, are intended to mean that the structure so defined is the nominal value and / or the geometric relationship described. In some examples, the terms "about," "approximately," and / or "substantially" can generally mean plus or minus 10% of the recited value or relationship, and / or can generally be assumed. For example, about 0.01 includes 0.009 and 0.011, about 0.5 includes 0.45 and 0.55, about 10 includes 9 to 11, and about 1000 includes 900 to 1100. The recited values may be desirable, but it should be understood that some variation can occur, for example, as manufacturing tolerances or other practical considerations (such as pressure or force applied through a portion of a device, conduit, lumen, etc.). Thus, the terms "about," "approximately," and / or "substantially" can 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, etc., or any combination thereof.

[0023] As used herein, the terms "proximal" and "distal" refer to the direction of approaching and the direction of moving away, respectively, for a user placing the device in a position in contact with the patient. Thus, for example, the end of the device that first touches the patient's body is the distal end, and the end on the opposite side of the device (e.g., the end of the device being operated by the user) is the proximal end of the device.

[0024] As described in further detail herein, any device and method can be used to procure a less contaminated body fluid sample, for example, by diverting a "pre-sample" volume of body fluid prior to collecting a "sample" volume of body fluid. Each of the terms "pre-sample", "first", and / or "initial" can be used interchangeably to describe and / or refer to a deposit, portion, or volume of body fluid that is transferred, diverted, and / or isolated prior to procuring the "sample" volume. In some embodiments, the terms "pre-sample", "first", and / or "initial" can refer to a predetermined, defined, desired, or given volume, portion, or amount of body fluid. For example, in some embodiments, a predetermined and / or desired pre-sample volume of body fluid can be about 0.1 milliliter (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 mL, about 50 mL, and / or any volume or ratio of volumes therebetween. In other embodiments, the pre-sample volume can be greater than 50 mL or less than 0.1 mL. In some particular embodiments, a predetermined and / or desired pre-sample volume can be from about 0.1 mL to about 5.0 mL. In other embodiments, the pre-sample volume can be, for example, the volume of a single drop of body fluid, several drops of body fluid, for example, a volume that combines any number of lumens forming a flow path (or a portion thereof) from a body fluid source to an initial collection chamber, portion, reservoir, etc. (e.g., an isolation chamber).

[0025] The terms "sample", "second", and / or "subsequent", when used in the context of the volume of a body fluid, can refer to a random volume, or a predetermined or desired volume, of the body fluid that is collected after transferring, diverting, isolating, and / or separating a pre-sample volume of the body fluid. For example, in some embodiments, the desired sample volume of the body fluid can be from about 10 mL to about 60 mL. In other embodiments, the desired sample volume of the body fluid can be less than 10 mL or greater than 60 mL. In some embodiments, for example, the sample volume can 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 selectively transfer a body fluid to one or more fluid collection devices (plural possible). In some embodiments, the fluid collection device can include, but is not limited to, a suitable container, receptacle, reservoir, bottle, adapter, dish, vial, syringe, device, diagnostic and / or testing equipment, and / or the like. As a specific example, in some embodiments, any of the embodiments and / or methods described herein can be used to transfer a sample volume to a sample reservoir, as detailed in U.S. Patent No. 8,197,420, entitled "Systems and Methods for Parenterally Procuring Bodily-Fluid Samples with Reduced Contamination", filed on December 13, 2007, (the "‘420 Patent"), which is hereby incorporated by reference in its entirety for disclosure.

[0027] In some embodiments, the sample reservoir can be a sample or a culture bottle, such as, for example, an aerobic culture bottle or an anaerobic culture bottle. In this way, the culture bottle can receive a body fluid sample and can then be tested (e.g., via 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 other organisms. In some embodiments, the culture bottle can receive a body fluid sample, and the culture medium (disposed therein) can be tested for the presence of any suitable organism. If such a test of the culture medium results in a positive outcome, the culture medium can be continuously tested using a PCR-based system to identify the specific organism. Further, as described in more detail herein In some embodiments, as described in more detail herein, diverting an initial volume of a pre-sample or body fluid can reduce and / or substantially eliminate contaminants in the body fluid sample that could otherwise lead to inaccurate test results.

[0028] The sample containers, reservoirs, bottles, dishes, vials, etc. described herein may be empty prior to receiving a sample volume of body fluid or may contain, for example, any suitable additives, culture media, substances, enzymes, oils, fluids, and / or the like. For example, in some embodiments, the sample reservoir can contain an aerobic or anaerobic culture medium (e.g., a nutrient-rich and / or environmentally controlled medium for promoting growth and / or other suitable culture medium(s)) that occupies at least a portion of the internal volume defined by the sample reservoir. In some embodiments, the sample reservoir can contain any suitable additive or the like, such as, for example, heparin, citrate, ethylenediaminetetraacetic acid (EDTA), oxalate, SPS, and / or the like, and also occupies at least a portion of the internal volume defined by the sample reservoir. In other embodiments, the sample reservoir can be any suitable container used to collect a specimen.

[0029] The term "culture medium" can be used to describe a substance configured to react with organisms (e.g., microorganisms such as bacteria) in body fluids, and the term "additive" can be used to describe a substance configured to react with a part of a body fluid (e.g., the constituent cells of blood, serum, synovial fluid, etc.). It should be understood that the sample reservoir can contain any suitable substance, liquid, solid, powder, lyophilized compound, gas, etc. Further, when referring to an "additive" within the sample reservoir, the additive can, as described above, be a culture medium such as an aerobic culture medium and / or an anaerobic culture medium, an additive and / or other suitable substances contained in a culture flask, or a combination of substances contained in a culture flask and / or other suitable reservoir. That is, it should be understood that the embodiments described herein can be used with any suitable fluid reservoir or the like containing any suitable substance. Further, any of the embodiments and / or methods described herein can be used to transfer the volume of a body fluid to a reservoir (or the like) that does not contain a culture medium, an additive, and / or other substances prior to receiving the flow of the body fluid.

[0030] Some of the embodiments are described herein as being used to procure a body fluid for one or more culture sample assays, but 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 such that the flow of the body fluid is transferred to any suitable device disposed in fluid communication therewith. Accordingly, while specific embodiments are described herein, the devices, methods, and / or concepts are not intended to be limited to such specific embodiments. Further, samples collected through the use of any of the devices described herein can be used in any suitable assay as described above.

[0031] The embodiments and / or portions thereof described herein can be formed or constructed with one or more biocompatible materials. In some embodiments, the biocompatible material can be selected based on one or more properties of the constituent materials, such as, for example, rigidity, toughness, durometer, bioreactivity, etc. Embodiments of suitable biocompatible materials include metals, glasses, ceramics, or polymers. Embodiments of suitable metals include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or their alloys. The polymeric materials can be biodegradable or non-biodegradable. Embodiments of suitable biodegradable polymers include polylactide, polyglycolide, polylactide-co-glycolide (PLGA), polyanhydrides, polyorthoesters, polyether esters, polycaprolactone , polyester amides, poly(butyric acid), poly(valeric acid), polyurethanes, and / or their blends and copolymers. Embodiments of non-biodegradable polymers include nylon, polyester, polycarbonate, polyacrylate, ethylene vinyl acetate and other acyl-substituted cellulose acetate polymers, non-degradable polyurethanes, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulfonated polyolefin, polyethylene oxide, and / or their blends and copolymers.

[0032] Embodiments and / or portions thereof described herein can include components formed from one or more parts, features, structures, etc. When referring to such components, it should be understood that the component can be formed by a single part having any number of sections, regions, parts, and / or properties, or can be formed by a plurality of parts or features. For example, when referring to a structure such as a wall or chamber, the structure can be considered a single structure having a plurality of parts, or a single structure having a plurality of separate sub-structures or the like joined to form the structure. Thus, a monolithically constructed structure can include, for example, a set of sub-structures. Such a set of sub-structures can include a plurality of parts that are either continuous or discontinuous with each other. The set of sub-structures can also be manufactured from a plurality of items or components that are manufactured separately and later joined (e.g., via welding, adhesives, snaps, and / or any suitable method).

[0033] Referring now to the drawings, FIG. 1 is a schematic view of a fluid control device 100 according to an embodiment. Generally, the fluid control device 100 (also referred to herein as the "control device" or "device") is configured to draw body fluid from a patient. A first portion or amount (e.g., an initial amount) of the drawn body fluid is isolated from a second portion or amount (e.g., a subsequent amount) of the drawn body fluid. In some embodiments, the first portion or amount can then be used for additional tests (e.g., tests that are not sensitive to potential contaminants), discarded, and / or reinjected into the patient. In this way, contaminants or the like can be isolated within the first portion or amount of the body fluid, leaving a second portion or amount of the body fluid that is substantially free of contaminants. The second portion or amount of the body fluid can then be used as a biological sample in one or more tests for medical diagnosis and / or treatment (e.g., blood culture tests or the like), as described in more detail herein. The first portion or amount of the body fluid can be discarded as waste or used in any suitable test that is unlikely to produce false, inaccurate, distorted, inconsistent, or unreliable results as a result of potential contaminants contained therein. In other embodiments, the first portion or amount of the body fluid can be injected back into the patient.

[0034] The control device 100 includes an inlet device 110 and a housing 130 that is in fluid communication with and / or configured to be disposed in fluid communication with the inlet device 110. The inlet device 110 can be any suitable device or set of devices configured to establish fluid communication between the housing 130 and a body fluid source such as, for example, a patient's vasculature. For example, in some embodiments, the inlet device 110 can be an intravenous (IV) catheter, a needle, a peripherally inserted central catheter (PICC), a syringe, one or more sterile tubes, and / or any other suitable lumen-containing device. In other embodiments, the inlet device 110 can be a port or the like such as, for example, a Luer Lok® or any other suitable coupler. In such embodiments, the inlet device 110 (e.g., the port or coupler) can be configured to couple to an access device that is in fluid communication with the patient (e.g., an IV catheter or needle that is placed or indwelling). In some embodiments, the inlet device 110 is integral with and / or monolithically formed with the housing 130 (e.g., the inlet device 110 can be disposed within the housing 130 and / or can form at least a portion of the housing 130, and vice versa). In other embodiments, the inlet device 110 is separated from the housing 130 and can be disposed in fluid communication therewith via an intermediate lumen-containing device such as, for example, a sterile tube or the like. In some such embodiments, for example, using a tube fitting, a coupling, and / or the like, the inlet device 110 (or a portion thereof) can be configured to form a fluid tight connection, coupling, port, and / or seal with the housing 130 (or a portion thereof) using any suitable connection mechanism.

[0035] The housing 130 includes an inlet 132, at least one outlet 136, and a separation and / or diversion portion 134. Further, the housing 130 defines one or more fluid flow paths 133 between the inlet 132 and the separation and / or diversion portion 134 and / or between the inlet 132 and the outlet 136. The housing 130 of the device 100 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 130 can be disposed within and / or form at least a portion of the inlet device 110. In such embodiments, any suitable portion of the housing 130 can be disposed within and / or formed by the inlet device 110, and vice versa. In other embodiments, the housing 130 can be formed separately from the inlet device 110 and can be physically and / or fluidly coupled to the inlet device 110. In some embodiments, the housing 130 can have a size based at least in part on, for example, the volume of body fluid stored at least temporarily within the separation and / or diversion portion 134.

[0036] The inlet 132 of the housing 130 is configured to be fluidly coupled to the inlet device 110 such that the housing 130 is disposed in fluid communication with a body fluid source, such as a patient's vasculature. As described above, in some embodiments, the inlet 132 of the housing 130 can be physically and fluidly coupled to the inlet device 110 via a lock, coupler, port, or the like. In other embodiments, the inlet 132 can be in fluid communication with the inlet device 110 via, for example, a lumen-containing device of a sterile tube or the like. In yet other embodiments, the inlet 132 of the housing 130 can form the inlet device 110 and / or can be formed integrally or monolithically with the inlet device 110.

[0037] One or more fluid flow paths 133 are configured to fluidly couple an inlet 132 with an isolation and / or diversion portion 134 and / or an outlet 136. In some embodiments, one or more fluid flow paths 133 can be configured to control one or more parameters and / or characteristics associated with the flow of fluid therethrough. For example, in some embodiments, the fluid flow path(s) 133 can have a length and / or width corresponding to and / or associated with the volume of body fluid conveyed therethrough. In some embodiments, the fluid flow path(s) 133 and / or a portion thereof can have a size, width, and / or diameter configured to adjust, increase, decrease, and / or control the pressure exerted through at least a portion of the fluid flow path(s) 133. In some embodiments, adjustment, increase, decrease, and / or control of the pressure through one or more portions of the housing 130 and / or the control device 100 can enhance the likelihood of withdrawing a clinically meaningful volume of body fluid (e.g., without undesirable consequences such as damage to the patient's anatomical structure, collapse, and / or "blowing out" of veins and / or the like). In other embodiments, the fluid flow path(s) 133 do not require pressure adjustment. Further, in some embodiments, the fluid flow path(s) 133 or a portion thereof can be configured to at least temporarily hold, store, contain, and / or isolate at least a portion of the collected body fluid. A portion thereof can be configured to at least temporarily hold, store, contain, and / or isolate at least a portion of the collected body fluid.

[0038] The isolation and / or diversion portion 134 (also referred to herein as the "isolation portion") is disposed in fluid communication with the inlet 132 via at least one fluid flow path(s) 133, at least temporarily. As described in further detail herein, the isolation portion 134 is configured to receive an initial flow and / or volume of body fluid from the inlet 132 in response to the housing 130 and / or the control device 100 being in a first state or mode of operation, and to isolate (e.g., separate, segregate, contain, hold, isolate, etc.) the initial flow and / or volume of body fluid therein from the housing 130 and / or the control device 100 as it transitions to a second state or mode of operation. In some embodiments, the isolation of the initial flow and / or volume of body fluid can also isolate contaminants or the like, such that the subsequent volume of body fluid withdrawn from the patient has a reduced amount of contaminants, as described in further detail herein.

[0039] The isolation portion 134 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the isolation portion 134 can be at least partially formed by the housing 130. In other embodiments, the isolation portion 134 can be a reservoir disposed and / or located within a portion of the housing 130. In other embodiments, the isolation portion 134 can be formed and / or defined by a portion of the fluid flow path 133. That is, the housing 130 can define one or more lumens and / or can include one or more lumen-defining devices configured to receive the flow of body fluid from the inlet 132, thereby defining the fluid flow path 133. In such embodiments, at least a portion of the lumen and / or a portion of the lumen-defining device(s) can form and / or define the isolation portion 134. Although the isolation portion 134 has been described above as being disposed within the housing 130, in other embodiments, the isolation portion 134 can be partially or wholly defined or contained within the inlet device 110. In such embodiments, at least a portion of the fluid flow path 133 can be disposed within the inlet device 110 and / or can be defined by the inlet device 110.

[0040] As described above, the isolation portion 134, whether disposed or formed in the housing 130 or the inlet device 110, is in fluid communication with the fluid flow path 133 and is configured to receive an initial volume or amount of body fluid drawn from a body fluid source. The isolation portion 134 can have any suitable volume and / or fluid volume. For example, in some embodiments, the isolation portion 134 can have a volume and / or fluid volume of from about 0.25 mL to about 5.0 mL. In some embodiments, the isolation portion 134 can have a volume measured with respect to the amount of body fluid (e.g., the initial or first amount of body fluid) configured to be transferred into the isolation chamber 134. For example, in some embodiments, the isolation chamber 134 can have a volume sufficient to receive an initial body fluid of body fluid below microliters (e.g., a small volume such as 20 drops of body fluid, 10 drops of body fluid, 5 drops of body fluid, 1 drop of body fluid, or any suitable volume therebetween). In other embodiments, the isolation portion 134 can have a volume sufficient to receive an initial volume of body fluid of, for example, about 5.0 mL, 10.0 mL, 15 mL, 20 mL, 30 mL, 40 mL, 50 mL, or more. In some embodiments, the isolation portion 134 can have a volume equal to, substantially equal to, and / or at least partially based on a volume of a portion of the fluid flow path 133 defined between the lumen of the inlet device 110, the lumen of the inlet 132, and between the inlet 132 and the isolation portion 134, and / or any combination thereof. In other embodiments, the isolation portion 134 is a portion of the inlet device 110, the inlet 132 of the housing 130, and the fluid flow path 1 33 of the individual and / or combined volumes of the flowing portions can have a volume equal to and / or at least partially based on.

[0041] Although not shown in FIG. 1, in some embodiments, the isolation portion 134 can include any suitable arrangement, configuration, and / or features, and / or can be formed from one or more materials configured to interact with a portion of the body fluid transferred therein. For example, in some embodiments, the housing 130 can include absorbent and / or hydrophilic materials disposed within the isolation portion 134 configured to interact with at least a portion of the body in a manner that absorbs, attracts, draws, holds, expands, and / or otherwise interacts with at least a portion of the body, and the fluid can then isolate and / or hold at least an initial portion of the body fluid within the isolation portion 134. Similarly, in some embodiments, the isolation portion 134 and / or a portion thereof can have a shape (e.g., surface area to volume ratio, capillary configuration, etc.) and / or can be formed from a material or coating (e.g., texture or pitted surface) configured to draw, attract, absorb, and / or hold body fluid.

[0042] In other embodiments, the isolation portion 134 can include, and / or be formed of, an expandable or foldable material and / or be configured to transition between a first state (e.g., while an initial portion of the body fluid is being transferred to the isolation portion 134) and a second state (e.g., after the initial portion of the body fluid has been transferred to the isolation portion 134) to facilitate the flow of body fluid into the isolation portion 134 and / or to hold or isolate the body fluid within the isolation portion 134. In some embodiments, the forces associated with and / or caused by the expansion or contraction of such a material can be operable to transition the housing 130 and / or the device 100 from a first state, position, configuration, etc. to a second state, position, configuration, etc. In some embodiments, the isolation chamber 134 and / or any other suitable portion of the housing 130 can include one or more chemicals, compounds, and / or the like configured to chemically interact with the body fluid transferred through a portion of the housing 130 that is operable to transition the control device 100 and / or the housing 130 between the first and second states (e.g., via a force or any other suitable means).

[0043] In some embodiments, the housing 130 and / or the isolation portion 134 can include and / or define a vent, port, opening, and / or the like that is in fluid communication with the isolation portion 134 and is configured to “vent” the isolation portion 134. In some embodiments, the housing 130 can include a semi-permeable member or membrane disposed within or around the vent hole to selectively allow the flow of air or gas through the vent hole while restricting or substantially preventing the flow of fluid (e.g., body fluid such as blood) through the vent hole. In some embodiments, venting of the isolation portion 134 as an initial portion of the body fluid can be transferred to the isolation portion 134 and enable the equalization of pressure between the isolation portion 134 and / or the isolation portion 134 and, for example, a fluid source and / or a portion of the fluid flow path outside the isolation portion 134, or the ambient pressure of the surrounding environment in which the isolation portion 134 is vented. In some embodiments, the equalization of pressure can be a factor in determining and / or defining how the body fluid flows through the housing 130 and / or the amount or volume of body fluid transferred to the isolation portion 134.

[0044] Upon further expansion, venting of the isolation portion 134 can allow the flow of air or gas to pass through the opening or semi-permeable member in response to displacement by the flow of body fluid. For example, in some embodiments, at least a portion of the internal volume of the isolation portion 134, the fluid flow path 133, and / or the housing 130 contains a volume of air or gas prior to use It can contain. When body fluid flows through the inlet 132 of the housing 130 and into the fluid flow path 133, the body fluid displaces at least a portion of the air or gas contained therein. Further, in some embodiments, the housing 130 can be in a first state or configuration in which the outlet(s) 136 are sealed or isolated before the initial portion of the body fluid is diverted and / or isolated. Thus, the opening(s) and / or semi-permeable member of the isolation portion 134 allow, facilitate, encourage, promote, draw in ventilation of the isolation portion 134 in response to the volume of air or gas displaced by the body fluid, and direct and / or otherwise direct the initial flow of the body fluid into the isolation portion 134, as described in more detail herein with respect to specific embodiments.

[0045] In some embodiments, an amount of air or gas disposed within the isolation portion 134 prior to use can be evacuated before body fluid is drawn into the isolation portion 134 through the fluid flow path(s) 133. In other words, in some embodiments, the isolation portion 134 can be pre-filled and / or evacuated (e.g., via an automated or manual process) before receiving an initial volume of body fluid. For example, in some instances, air or other gaseous contents disposed within the isolation portion 134 prior to use can be expelled in response to an external force and / or compression of the isolation portion 134, such that upon release of the compression (after the inlet device 110 is placed in communication with the body fluid), the volume within the isolation portion 134 increases and then creates a negative pressure within the isolation portion 134 operable to draw an initial flow of body fluid into the isolation portion 134. As another example, the contents of the isolation portion 134 can be removed prior to contacting the body fluid source by drawing the inlet device 110 through a vent or opening using any suitable suction system. In some such embodiments, the contents of the isolation portion 134 can be removed or evacuated via a source of negative pressure disposed in selective fluid communication with or disposed in communication with the isolation portion 134, such as, for example, a syringe, a vacuum container, a sample or culture flask, a pump, and / or any other suitable source of negative pressure in the fluid. Further, in some embodiments, such a source of negative pressure can be configured to receive a flow of body fluid through the outlet 136 after an initial volume of body fluid has been transferred to and isolated within the isolation portion 134.

[0046] In some embodiments, the housing 130 and / or the isolation portion 134 can enable and / or allow adjustment of the negative pressure generated in and / or exerted through the isolation portion 134. For example, the size, shape, material, and / or physical structure of the isolation portion 134 can be configured to control the rate at which the volume of the isolation portion 134 increases, which can then control the magnitude of the negative pressure generated within the isolation portion 134. In some embodiments, a desired combination of components, size, shape, material, and / or configuration is selected to draw body fluid (e.g., blood from a vascular structure) from, for example, a patient with a physical impairment (e.g., a diseased patient, a hypotensive patient, an obese patient, a pediatric patient, etc.), and a different combination of components, size, shape, material, and / or configuration can be selected to draw body fluid from a healthy patient or a patient without other impairments.

[0047] In some embodiments, the fluid control device 100 can include an actuator 150. The actuator 150 can be included within the housing 130 (as shown in the schematic of FIG. 1), or the actuator 150 can be included in any other suitable part of the device 100. The actuator 150 can be configured to transition the housing 130 from a first state (e.g., a state in which an initial portion of the body fluid can be transferred to the isolation portion 134) to a second state (e.g., after the initial portion of the body fluid has been transferred to the isolation portion 134). In some embodiments, the actuator 150 can be mechanically coupled to operate a (portion that opens and / or closes the fluid flow path 133) switch. For example, in some embodiments, one or more mechanical actuators that can move within or be moved within the isolation portion 134 generate a change in volume and / or a pressure differential between the isolation portion 134 and, for example, a fluid source and / or a portion of the fluid flow path 133 outside the isolation portion 134.

[0048] In some embodiments, the actuator 150 can be enabled to switch the state of the control device 100 by manipulating the flow of fluid through various portions of the fluid flow path 133 in any suitable manner. For example, in some embodiments, the movement of the actuator 150 can create a pressure differential between the isolation portion 134 and the surrounding environment to which the isolation portion 134 is vented. For example, a mechanical actuator can be in an initial state prior to use of the control device 100, and the pressure differential between the isolation portion 134 and the body fluid source is based on, for example, a positive pressure associated with the patient's vasculature (i.e., blood pressure). In such embodiments, the pressure differential can be relatively small. In some such embodiments, the mechanical actuator can transition from the initial state to a subsequent state at the start of the flow of an initial volume of body fluid, whereby the transition of the mechanical actuator can vent air or gaseous contents within the isolation portion 134, create a negative pressure differential between the isolation portion 134 and the body fluid source, and draw the flow of body fluid into the isolation portion 134. In some such embodiments, the transition of the mechanical actuator can also be configured to change access to one or more openings to allow the flow of air or gas disposed within a portion of the isolation portion 134 through the opening (not shown in FIG. 1). For example, in some embodiments, the actuator 150 can be configured to physically block or occlude one or more openings of one or more portions of the fluid flow path 133 that can be introduced or removed through the operation of one or more external control mechanisms (e.g., switches, stopcocks, levers, clamps, or flow blocks actuated by push buttons), as described in more detail below.

[0049] In some embodiments, the amount of movement of the mechanical actuator and / or the equalization of pressure after movement of the mechanical actuator can be a factor in determining and / or defining how body fluid flows through the control device 100 and / or the amount or volume of body fluid transferred to the isolation portion 134, as disclosed in more detail below with respect to particular embodiments.

[0050] In other embodiments, the method of actuating the actuator can involve user intervention (e.g., an external force applied by the user). In some such embodiments, the isolation chamber 114 can contain structures or substances that are actuated or deactuated to assist in moving or transitioning the actuator from an initial state to a resultant state. The structures or substances can be actuated by any suitable mechanism, such as by contact with a small amount of body fluid (or any other fluid), over a predetermined period of time, and / or by a change in pressure or temperature, and / or the like.

[0051] In some embodiments, the outlet(s) 136 of the housing 130 are configured to be in fluid communication with and / or disposed in fluid communication with the fluid flow path 133. The outlet 136 can be any suitable outlet, opening, port, lock, seal, coupler, adapter, etc., and is configured to be fluidly coupled to a fluid collection device 160, such as a fluid collection device 160, a syringe, an intermediate lumen-containing device, and / or any other suitable body fluid collection or transfer device. In some embodiments, the outlet 136 can be formed monolithically with the fluid collection device 160. In other embodiments, the outlet 136 can be at least temporarily coupled to the fluid collection device 160 via an adhesive, a press fit, a mechanical fastener, a screw connection, a piercing or puncturing arrangement, any number of mating recesses, and / or other suitable couplings or combinations thereof. Similarly stated, the outlet 136 can be physically (e.g., mechanically) and / or fluidly coupled to the fluid collection device 160 such that the internal volume defined by the fluid collection device 160 is in fluid communication with the outlet 136. In still other embodiments, the outlet 136 can be operably coupled to the fluid collection device 160 via an intervening structure (not shown in FIG. 1), such as a flexible sterile tube.

[0052] As described above, in some embodiments, the placement of at least one outlet 136 can be such that the outlet 136 is physically and / or fluidly sealed before being coupled to the fluid collection device 160. In some embodiments, such a sealed placement can facilitate, direct, and / or otherwise result in an initial flow of body fluid to the isolation portion 134 rather than the outlet 136. In some embodiments, the fluid collection device 160 can define and / or actuate a negative pressure that draws body fluid from the body fluid source through the outlet 136, through the fluid control device 100, such that an initial volume of the body fluid is transferred to the isolation portion 134 and then drawn into the fluid collection device 160 after being isolated. In some embodiments, the fluid collection device 160 can be selectively placed in fluid communication with at least a portion of the isolation portion 134 such that at least a portion of the negative pressure associated with the fluid collection device 160 is applied to the isolation portion 134 or through the isolation portion, and an initial volume of the body fluid is placed into the isolation portion 134 without transferring the amount of the body fluid to the fluid collection device 160 (e.g., through the use of a selectively permeable member of an air permeable / fluid impermeable barrier or the like).

[0053] As described above, the fluid collection device 160 can be any suitable device for receiving and / or at least temporarily containing body fluid. In some embodiments, the fluid collection device 160 can be, for example, a fluid collection device for containing body fluid, such as those described in detail in the '420 patent incorporated by reference above. In other embodiments, the fluid collection device 160 can be substantially similar or equivalent to a known sample container, such as, for example, a Vacutainer® (manufactured by Becton, Dickinson and Company ("BD")), a 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, syringe, dish, pump, and / or the like.

[0054] In some embodiments, the fluid collection device 160 can include and / or define negative pressure conditions prior to use and can then facilitate the withdrawal of body fluid from a patient into the fluid collection device 160 through the control device 100 via a vacuum or suction force. In embodiments where the fluid collection device 160 is a vacuum container or the like, the user can couple the fluid collection device 160 to the outlet 136 after an initial portion of the body fluid has been transferred and / or isolated to the isolation portion 134, thereby restricting and / or substantially preventing the initial portion of the body fluid (potentially containing contaminants) from being transferred to the fluid collection device 160. In other embodiments, at least a portion of the negative pressure associated with the fluid collection device 160 can be used to create a negative pressure differential, for example, between the isolation portion 134 and the inlet 132 operable to draw body fluid into the isolation portion 134, without drawing the body fluid into the fluid collection device 160 prior to the initial volume of the body fluid being isolated in the isolation portion 134.

[0055] The outlet 136 and / or the housing 130 of the control device 100 have been described above as being fluidly connected to and / or otherwise arranged to be in fluid communication with the fluid collection device 160. However, in other embodiments, the control device 100 can be used in combination with any suitable bodily fluid collection device and / or system. For example, in some embodiments, the control device 100 described herein can be used in any suitable fluid transfer device as described in U.S. Patent Publication No. 2015 / 0342510, filed Jun. 2, 2015, titled "Ster ile Bodily-Fluid Collection Device and Methods" (referred to herein as the "´510 publication"), which is hereby incorporated by reference in its entirety. More specifically, the control device 100 can be used in an "integrated" or pre-assembled device (such as those described in the ´510 publication) to receive an initial amount of bodily fluid, isolate it, and reduce and / or eliminate contaminants from subsequent amounts of bodily fluid.

[0056] As described above, the device 100 can be used, for example, 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 embodiments, a user, such as a physician, internist, nurse, phlebotomist, technician, etc., can operate the device 100 to establish fluid communication between the inlet device 110 and a bodily fluid source (such as a patient's vein, cerebrospinal fluid (CSF) from the spinal cavity, urine collection, and / or the like). As a specific example, in some embodiments, the inlet device 110 can include a needle or the like that can be operated to pierce the patient's skin and insert at least a portion of the needle into the patient's vein, thereby placing the inlet device 110 in fluid communication with a bodily fluid source (such as a vein, IV catheter, PICC, etc.).

[0057] The housing 130 can be coupled to the inlet device 110 either before or after the inlet device 110 is arranged to be in fluid communication with the body fluid source. In other embodiments, the inlet 132 of the housing 130 includes, forms, and / or is formed monolithically with the inlet device 110. Thus, establishing fluid communication between the inlet device 110 and the body fluid source by coupling or forming the inlet 132 to the inlet device 110 disposes the housing 130 in fluid communication with the body fluid source. Thus, body fluid can flow from the body fluid source (e.g., a patient's vein), through the inlet device 110, and into the housing 130.

[0058] In some embodiments, the actuator 150 of the device 100 can be configured to place the control device 100 in a first state (e.g., a state in which an initial portion of the body fluid can be transferred to the isolation portion 134). Thus, since the inlet 132 of the housing 130 is in fluid communication with the body fluid source, the actuator 150 can place the control device 100 in the first state, forming a fluid connection between the body fluid source and the isolation portion 134 via one or more portions of the fluid flow path 133. In other embodiments, the actuator 150 can be configured to maintain the control device 100 in a storage and / or pre-use configuration or state in which the inlet 132 of the housing 130 is isolated and / or insulated from the isolation portion 134 and one or more outlets 136. In such embodiments, the actuator 150 can be operated, for example, to transition the control device 100 from the storage configuration and / or state to the first state after the inlet device 110 has established fluid communication with the body fluid source.

[0059] As described above, the fluid flow path 133 of the housing 130 establishes fluid communication between the inlet 132 and the isolation portion 134 and / or the outlet 136. In some embodiments, the arrangement of the housing 130 and / or the actuator 150 is such that an initial portion (also referred to herein as the "initial volume" or "first volume") of the volume of body fluid, as when a volume of body fluid is transferred to and / or through the inlet 132, flows from the inlet 132 through at least a portion of the fluid flow path 133 to the isolation portion 134. That is, in some embodiments, the control device 100 can be placed in a first or initial state (e.g., via the actuator 150) such that an initial portion or volume of body fluid can flow into the isolation portion 134 through and / or into at least a portion of the fluid flow path 133. This can be done.

[0060] For example, in some embodiments, the actuator 150 can be in a first configuration, state, mode, and / or position when the control device 100 is in an initial state. The first configuration of the actuator 150 can be such that, for example, the actuator 150 enables fluid communication to be established between the inlet 132 and the isolation portion 134 via at least a portion of the fluid flow path 133, and the actuator 150 can be configured to block, isolate, and / or isolate the inlet 132 from the outlet 136 or the fluid collection device 160. For example, in the first configuration, the actuator 150 can define an opening, aperture, orifice, conduit, channel, flow path, or the like to permit fluid flow from the inlet 132 toward the isolation portion 134, and can block or close an opening, aperture, orifice, conduit, channel, flow path, or the like to block fluid flow from the inlet 132 toward the outlet 136 or the fluid collection device 160. In some embodiments, the first configuration of the actuator 150 can be a resting or initial configuration (e.g., a configuration prior to use) of the actuator 150. That is, the actuator 150 (and the control device 100) can be in the first configuration (and the first state) to enable fluid flow from the inlet device 110 toward the isolation portion 134 without user intervention. In other embodiments, the actuator 150 can be arranged and / or transitioned to the first configuration upon operation by the user.

[0061] In some embodiments, when the control device 100 is in its initial state, the isolation portion 134 is vented and the outlet 136 is isolated (e.g., via the actuator 150). In this way, body fluid entering the fluid flow path 133 displaces the volume of air or gas disposed therein, and venting of the isolation portion 134 allows the volume of air or gas to vent through the isolation portion 134, and then, before the body fluid flows to the outlet 136, the initial portion of the body fluid is urged, drawn, and / or otherwise diverted to the isolation portion 134. In some embodiments, venting of the isolation portion 134 can be accomplished by any other suitable method. In some embodiments, for example, the actuator 150 can be in its initial configuration or the like before the inlet device 110 is arranged to be in fluid communication with a source of body fluid. For example, the isolation portion 134 can be compressed (e.g., by the user and / or pre-compressed or evacuated during manufacture or the like) to discharge its contents before the inlet device 110 is brought into contact with a source of body fluid (e.g., a patient's vasculature), and the air or gas disposed in the isolation portion 134 is released to the surrounding environment. In such embodiments, the actuator 150 can be switched to a first position that allows body fluid to flow from the inlet 132 toward the now-empty or evacuated isolation portion 134 from the initial or vented configuration. In some embodiments, the initial or vented configuration of the actuator 150 can be different from the first configuration. In other embodiments, the initial or vented configuration can be equivalent to the first configuration.

[0062] In some cases, after venting or exhausting the isolation portion 134, transitioning the actuator 150 from an initial or vented configuration to a first configuration (e.g., the control device 100 is in a first state) can help establish an operable negative pressure differential to draw body fluid into the isolation portion 134 through at least a portion of the inlet device 110 and the fluid flow path 133. In some embodiments, discharging the contents of the isolation portion 134 prior to establishing contact with a body fluid source can remove air or gaseous bubbles that could potentially be introduced into the body fluid source and / or the body fluid sample. In other embodiments, the device 100 can be stored prior to use with a fluid or gas disposed in the isolation portion 134 that is configured to maintain a sterile environment within the isolation portion 134. In such embodiments, evacuating the isolation portion 134 prior to establishing contact with a body fluid source can expel such fluid or gas. Further, when the actuator 150 is in a vented configuration and / or a first configuration, the actuator 150 can separate, close, isolate, and / or otherwise isolate the outlet 136 from the inlet 132 of the housing 130. Isolation of the outlet 136 from the body fluid source can prevent, for example, negative pressure within the fluid collection device 160 from drawing body fluid into the fluid collection device 160 prior to withdrawing and isolating an initial volume of body fluid within the isolation portion 134. When in a vented configuration and / or a first configuration, the actuator 150 can separate, close, isolate, and / or otherwise isolate the outlet 136 from the inlet 132 of the housing 130. Isolation of the outlet 136 from the body fluid source can prevent, for example, negative pressure within the fluid collection device 160 from drawing body fluid into the fluid collection device 160 prior to withdrawing and isolating an initial volume of body fluid within the isolation portion 134.

[0063] In some embodiments, the negative pressure can be introduced into the isolation portion 134, which includes any intermediate portion of the actuator 150 at the first position, and the flow path 133 connecting the isolation portion 134 to the inlet 132 and / or the inlet device 110 using any suitable user-mediated or non-user-mediated method. In other embodiments, the isolation portion 134 and the flow path 133 can be placed under evacuation, ventilation, and / or reduced pressure or negative pressure during manufacture or the like (also referred to herein as "pre-filling"). The negative pressure can then draw or encourage fluid flow towards and into the isolation portion 134. For example, in some embodiments, the isolation portion 134, the connecting fluid flow path 133, and / or the inlet device 110 can be positioned at a relatively lower altitude than the body fluid source (e.g., the patient's vasculature) to utilize gravity to assist fluid flow. A vent or seal in communication with the isolation portion 134 can be configured to allow air or gas (not a liquid such as body fluid) to flow unidirectionally from the isolation portion 134. In some embodiments, the negative pressure associated with the fluid collection device 160 (e.g., a vacuum container, syringe, etc.) can be used to draw body fluid into the isolation portion 134 without drawing the body fluid into the fluid collection device 160 until an initial portion or volume of the body fluid is isolated.

[0064] Although not shown in FIG. 1, in some embodiments, the control device 100 and / or the housing 130 can include members, devices, mechanisms, features, etc. configured to adjust the magnitude of the negative pressure to which the isolation chamber 134 is exposed. For example, in some embodiments, the housing can include a valve, a membrane, a porous material, a restrictor, an orifice, and / or any other suitable member, device, and / or feature configured to adjust pressure. In some embodiments, adjusting and / or controlling the magnitude of the pressure to which the isolation chamber 134 is exposed can, in turn, adjust the magnitude of the pressure applied to the body fluid and / or into the patient's vein. In some embodiments, such pressure adjustment can reduce the likelihood of hemolysis of a blood sample and / or collapsing a vein (e.g., this can be particularly important in vulnerable patients who require microbiological and / or other diagnostic tests associated with the use of the control device 100). Additionally, adjustment of 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, adjusting 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 control device 100 from the first state to the second state can be known, predetermined, calculated, and / or controlled. Thus, in some embodiments, adjusting the negative pressure can at least partially control the amount or volume of body fluid transferred into the isolation chamber 134 (i.e., the volume of the initial amount of body fluid can be controlled).

[0065] The initial portion and / or amount of the body fluid can be any suitable volume of the body fluid, as described above. For example, in some embodiments, the control device 100 can remain in the first state until a predetermined and / or desired volume (e.g., an initial volume) of the body fluid is transferred to the isolation portion 134. In some embodiments, the initial volume can be associated with and / or at least partially based on the volume of the isolation portion 134. In other embodiments, the initial volume is associated with and / or at least partially based on the amount or volume of body fluid that can be absorbed by an absorbent material, a swellable material, a hydrophilic material, a wicking material, and / or other suitable materials disposed in the isolation portion 134. Likewise, the initial volume can be associated with and / or at least partially based on the amount or volume of body fluid sufficient to completely wet or saturate a semipermeable member or membrane configured to vent the isolation portion 134 (e.g., the isolation portion 134 has transitioned from a “vented” state to a “sealed” state or the like). In yet other embodiments, the control device 100 can be configured to transfer a volume of body fluid (e.g., an initial volume) to the isolation portion 134 until a pressure differential occurs between the isolation portion 134 and the fluid flow path 133, and the body fluid source is brought to a substantially equilibrium state and / or otherwise reduced below a desired threshold. In some embodiments, the pressure differential can be established automatically or via direct or indirect intervention (e.g., by a user).

[0066] In some embodiments, the initial volume can be measured at the time of procurement by using any suitable method, such as, for example, associating the initial volume with one or more portions of the fluid flow path 133 that connect the inlet 132 to the isolation portion 134, or being part of a stepwise isolation portion 134 or a stepwise tube. When the initial volume of the collected fluid reaches a predetermined value, the actuator 150 can transition from the first configuration to the second configuration, thereby stopping the further flow of fluid to the isolation portion 134 of the body fluid and transitioning the control device 100 from the first state to the second state. After the initial volume of the body fluid has been transferred and / or diverted to the isolation portion 134, the initial volume is isolated, separated, held, contained, isolated, etc. within the isolation portion 134 by transitioning the actuator 150 to the second configuration. As described in more detail herein, in some embodiments, contaminants such as microorganisms or the like present in the dermis removed during a venipuncture event, for example, can be mixed in and / or included in the initial volume of the body fluid and thus are isolated within the isolation portion 134 when the initial volume is isolated therein.

[0067] When the initial volume is transferred and / or diverted to the isolation portion 134, the device 100 can transition (or be transitioned) to a second state in which a subsequent volume(s) of the body fluid can flow through at least a portion of the fluid in the flow path 133 from the inlet 132 to the outlet 136. 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) when the initial volume of the body fluid is isolated in the isolation portion 134. For example, in some embodiments, filling the isolation portion 134 to volume and / or fully saturating, wetting, and / or impregnating an absorbent or similar material disposed in the isolation portion 134 can cause further transfer of the body fluid to the isolation portion 134 to be restricted and / or substantially prevented.

[0068] In some embodiments, as described above, the control device 100 can be transitioned from the first state to the second state by switching or actuating the actuator 150. The actuator 150 enables fluid to flow towards the isolation portion 134 while blocking the fluid flow towards one or more outlets 136 or the fluid collection device 160, and can be configured to switch from a first configuration (e.g., position, state, operating mode, arrangement, etc.) to a second configuration, such that the isolation portion 134 is isolated and / or blocked and fluid is allowed to flow towards the outlet 136 or the fluid collection device 160.

[0069] In some embodiments, the control device 100 can be transitioned from the first state to the second state through various passive or active mechanisms, or a combination of passive and active mechanisms. Similarly, the actuator 150 can passively assume various configurations, states, and / or positions (e.g., storage state, ventilation state, first state, second state, etc.) based on one or more other changing parameters, during the procurement of body fluid from the user, or through active user intervention, or through a combination of passive and active mechanisms. In some embodiments, for example, the actuator 150 can assume various states based on passive mechanisms that do not require or involve user intervention. For example, the actuator 150 can transition between states in response to the passage of time, changes in volume, changes in physical properties such as saturation of the hydrophilic material in the isolation portion 134, changes in the degree of negative pressure applied to draw or push fluid towards or into the isolation portion 134, and / or the like. The actuator 150 can also utilize other changing parameters such as changes in the applied gravitational force to draw fluid into the appropriately positioned isolation portion 134.

[0070] In some embodiments, the actuator 150 can be actively transitioned through user intervention from a first state to a second state. In other words, the actuator 150 can be manually transitioned by the user who directly controls the direction of the body fluid flow with the actuator 150, thereby also transitioning the control device 100 from the first state to the second state. As described above, the actuator 150 can switch from the first state to the second state based on any suitable criteria (e.g., the amount of body fluid collected in the isolation portion 134, the pressure difference that promotes the fluid flow into the isolation portion 134, etc.), or based on any other suitable instruction or user discretion. Thus, when the criteria are met, the user can operate the actuator 150 (e.g., a switch, valve, port, stopcock, etc.) such that the actuator 150 transitions from the first state to the second state.

[0071] The fluid collection device 160 can be fluidly coupled to the outlet 136 before or after the housing 130 is placed in the second state. Similarly, in some embodiments, the fluid collection device 160 can be fluidly coupled to the outlet 136 before or after the actuator 150 transitions from the first configuration or state to the second configuration or state. The arrangement of the outlet 136 can be such that the outlet 136 remains sealed until the initial volume of body fluid is isolated in the isolation portion 134, regardless of whether the fluid collection device is coupled to the outlet 136. Thus, when the fluid collection device 160 is fluidly coupled to the outlet 136 and the housing 130 is in the second state (e.g., the initial volume of body fluid is isolated within or by the isolation portion 134, the actuator 150 is in the second configuration or state, and fluid communication between the inlet 132 and the outlet 136 is established), subsequent volume(s) of body fluid can flow from the inlet 132 through the fluid flow path 133, the actuator 150, and the outlet 136 to the fluid collection device 160. Thus, as described above, isolating the initial volume of body fluid in the isolation portion 134 before collecting or procuring one or more sample volumes of body fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes. Further, in some embodiments, the arrangement of the control device 100 and / or the actuator 150 can be such that the control device 100 and / or the actuator 150 cannot transition to the second state before collecting and isolating the initial volume of the isolation portion 134.

[0072] Figures 2 to 4 show (in cross-section) at least a part of the fluid control device 200 according to the embodiment. As described above with respect to the control device 100, the fluid control device 200 (also referred to herein as the "control device" or "device") is configured to draw out and isolate a first portion or amount (e.g., an initial amount) of body fluid from a patient, and then draw out a second portion or amount (e.g., a subsequent amount) of body fluid for use, e.g., in sampling and / or testing of the body fluid. By isolating the first portion or amount of body fluid, contaminants or the like, such as microorganisms present on the skin removed during venipuncture, are likewise isolated, leaving a second portion or amount of body fluid that is substantially free of contaminants. In some embodiments, the portions and / or aspects of the control device 200 are substantially the same in form and / or function as the corresponding portions and / or aspects of the control device 100 described above with reference to FIG. 1. The corresponding portions and / or aspects of the control device 100 are substantially the same in form and / or function. Accordingly, such similar portions and / or aspects are not described in further detail herein.

[0073] As shown in FIGS. 2 to 4, the control device 200 includes a housing 230 that is similar in structure and / or function to the housing 130 of the fluid control device 100 described above, and an actuator 250 that is similar in structure and / or function to the actuator 150 described above with respect to the fluid control device 100. The figures of FIGS. 2 to 4 show the actuator 250 taking various configurations and / or positions (e.g., a venting position, a first position, and a second position) as described in further detail herein.

[0074] The housing 230 can be any suitable device or set of devices configured to (1) receive a flow of body fluid, (2) store and isolate a first or initial volume of body fluid, and (3) direct or divert a subsequent flow of body fluid to a fluid collection device, as described in more detail herein. The housing 230 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 230 can be formed of a relatively rigid material such as plastic or the like and configured to retain its shape and / or form when exposed to pressure changes and / or flow at the fluid inlet or outlet. In other embodiments, the housing 230 can be made of a flexible material that can withstand compression and / or other similar forces used to expel the contents of the isolation portion 234 prior to use, as described above with respect to the housing 130 of the fluid control device 100.

[0075] As shown in FIGS. 2-4, the housing 230 includes an inlet 232 and an outlet 236. The inlet 232 is in fluid communication with and / or configured to be in fluid communication with an inlet device (not shown). Generally, the inlet device can be any suitable device or set of devices configured to establish fluid communication between the housing 230 and a body fluid source, such as a patient's vasculature, as described above with respect to the control device 100. The outlet 236 is in fluid communication with and / or configured to be in fluid communication with a fluid collection device (not shown in FIGS. 2-4) such as a fluid collection device, syringe, culture flask, and / or the like. The fluid collection device can be similar to any of the fluid collection devices described above with reference to the control device 100.

[0076] The housing 230 includes and / or defines one or more fluid flow paths 233 and a separation and / or diversion portion 234. The fluid flow path(s) 233 can be in any suitable arrangement and is configured to selectively establish fluid communication between the inlet 232 and the separation and / or diversion portion 234 and / or between the inlet 232 and the outlet 236. The separation and / or diversion portion 234 (also referred to herein as the "separation portion") can be of any suitable shape, size, and / or configuration and is configured to receive an initial volume of body fluid, which can include contaminants or other undesirables, and, as described in further detail herein, to isolate the initial volume of body fluid and contaminants and / or other undesirables within the separation portion 234 after receiving the initial volume.

[0077] As described above, in some embodiments, the actuator 250 can be associated with, included in, and / or coupled to the housing 230, as shown in FIGS. 2 - 4. The actuator 250 can be any suitable member, device, mechanism, etc. configured to transition between at least two different operating states so as to selectively control the flow of fluid through the housing 230. For example, included in device 100 As described above with respect to actuator 150, the actuator 250 can be a switch, valve, port, membrane, movable channel, clamp, and / or the like that is configured to manipulate the flow of fluid (either directly or indirectly) through the housing 230.

[0078] The actuator 250 can be formed monolithically, or as an integral part of the housing 230, or separately formed and at least operably coupled to the housing 230. In the embodiments shown in FIGS. 2-4, the actuator 250 can be a three-way valve, port, plug, and / or the like, and can be configured to change its configuration to allow fluid to flow in a selected direction by forming paths, conduits, and / or channels. The actuator 250 can be arranged in alignment or adjacent to various portions of the fluid flow path 233 to control the flow of fluid through the housing 230, and can include lumens, channels, openings, flow paths, and / or the like. The actuator 250 is configured to be arranged in different configurations that allow the flow of fluid through a selected portion of the actuator 250 and through the fluid flow path 233 while blocking the flow of fluid through other portions of the fluid flow path 233.

[0079] The configuration of the actuator 250 can be switched, modified, and / or operated by any of a passive method, active intervention by the user, or a combination of active and passive methods, as described above with respect to the actuator 150. For example, in some embodiments, the actuator 250 can be a rotary valve driven by a spring or damper mechanism such that it switches at positions occurring over a predetermined time or such that the actuator 250 can be switched between various positions when a specific criterion of a predetermined pressure difference and / or the like is met. For example, the actuator 250 can be a push button, toggle, switch, lever, dial, etc., and when engaged by the user, can move the actuator 250 from a first state or position to a second state or position. As will be described in more detail herein, in some embodiments, the actuator 250 can be configured to establish fluid communication between the inlet 232 and the isolation portion 234 when in a first state, configuration, and / or position, and can be configured to establish fluid communication between the inlet 232 and the outlet 236 when in a second state, configuration, and / or position.

[0080] In some embodiments, the actuator 250 can be configured in any other suitable form. For example, instead of a three-way valve (e.g., a rotary valve, port, and / or the like), the actuator 250 can be a two-way valve or any other suitable path selector of a Y-shaped or T-shaped configuration that allows selection between an open flow path connecting the inlet 232 to the isolation portion 234 and an open flow path connecting the inlet 232 to the outlet 234.

[0081] In some embodiments, the actuator 250 can be an opening and closing mechanism for existing channels, paths, and / or conduits, and thus does not form new channels or conduits, but enables or blocks access to one or more existing channels or conduits. For example, the actuator 250 can be configured to open (or block) at least a portion of the fluid flow path 233 that connects the isolation portion 234 to the inlet 232, while blocking (or opening) at least a portion of the fluid flow path 233 that connects the outlet 236 to the inlet 232. In some embodiments, the actuator 250 can be configured as a rotary valve (such as shown in FIGS. 2-4), a linear valve having a series of seals (e.g., a plunger), and / or any other suitable valve.

[0082] The operation of the actuator 250 in opening and blocking one or more flow paths can be configured to be either sequential or simultaneous. Similarly, the actuator 250 、It can be designed such that only a specific number of flow paths are opened in any particular configuration. For example, the actuator 250 can be designed such that only one of the isolation portion 234 or the outlet 236 can be fluidly connected to the inlet 232 in any given configuration. In some other embodiments, the actuator 250 can allow fluid communication between multiple portions of the housing 230. For example, in some embodiments, the actuator 250 can be designed such that fluid communication can be established substantially simultaneously between the inlet 232 and the isolation portion 234, and similarly between the inlet 232 and the outlet 236. In some such embodiments, the actuator 250 can allow the selection of fluid flow paths through one or more control mechanisms other than blocking or closing (e.g., by operating a pressure difference or other mechanism that promotes fluid flow in a specific direction). In some embodiments, the actuator 250 can operate by physically permitting or blocking access to a particular fluid flow path such that the opening of a first fluid flow path (e.g., the fluid flow path connecting the inlet 232 to the isolation portion 234) automatically results in the blocking of another fluid flow path (e.g., the fluid flow path connecting the inlet 232 and the outlet 236), and vice versa. However, in some embodiments, the permitting and / or blocking of a particular fluid flow path can allow for flexibility in the user's discretion or control in the selection of one or more fluid flow paths.

[0083] In some embodiments, the actuator 250 can be arranged in a storage and / or ventilation configuration, as described above with respect to the actuator 150 of the control device 100. For example, FIG. 2 shows the actuator 250 in a storage and / or ventilation configuration before use for the procurement of body fluid. As described above, in the storage and / or ventilation configuration, the actuator 250 can fluidly isolate the inlet 232 from the isolation portion 234 and the outlet 236. Although not shown in FIG. 2, in some embodiments, the outlet 236 can be substantially sealed before use. In some embodiments, the user can transition the outlet 236 to an open configuration and / or the like, thereby enabling the removal, outflow, or discharge of air or other gaseous contents disposed in the isolation portion 234 (e.g., via the outlet 236) before the isolation portion 234 is placed in fluid communication with the inlet 232. For example, ventilation of the contents of the isolation portion 234 can evacuate the volume within the isolation portion 234, thereby enabling body fluid to be drawn into the volume. In some embodiments, ventilation can be operable to create a negative pressure within the isolation portion 234 that draws or promotes the flow of body fluid from a source of body fluid (e.g., a patient's vasculature) into the isolation portion 234 when the actuator 250 places the isolation portion 234 in fluid communication with the inlet 232. In some embodiments, ventilation, filling, and / or evacuation of the isolation portion 234 can be responsive to the fluid collection device being coupled to the outlet 236. For example, in some such embodiments, the fluid collection device can define a negative pressure or the like that draws air or gas from the isolation portion 234 through the actuator 250 and through the outlet 236 (during the ventilation configuration).

[0084] FIG. 2 shows that the isolation portion 234 can be vented through the outlet 236. However, in other embodiments, the housing 230 is configured to communicate with the isolation portion 234 and allow venting of the contents disposed in the isolation portion 234 prior to use of the device 200 (not shown in FIGS. 2 - 4), and can include and / or define any suitable opening(s), outlet(s), vent(s), port(s), etc. In some embodiments, access to these vents or the like can be controlled by the actuator 250 and / or any other suitable device. In other embodiments, the isolation portion 234 is not vented prior to using the control device 200. In such embodiments, the actuator 250 can be stored in a storage configuration (as shown in FIG. 2), and / or the inlet 232 can be stored in a configuration in fluid communication with the isolation portion 234.

[0085] As shown in FIG. 3, after venting the isolation portion 234 and / or when otherwise ready to use the control device 200, the actuator 250 can be positioned in a first configuration or position to establish fluid communication between the inlet 232 and the isolation portion 234. For example, in some embodiments, the actuator 250 can be a rotary valve or the like that can be switched from a storage and / or venting configuration (FIG. 2) to the first configuration (FIG. 3) by turning and / or rotating the actuator 250 (e.g., by rotating the actuator 250 90 degrees in the clockwise direction). The clockwise rotation or similar switch at the position of the actuator 250 can be implemented by any suitable mechanism. For example, the rotary valve actuator 250 can be rotated over a predetermined period driven by a spring mechanism (e.g., a torsion spring that can provide a stable torque for rotating the actuator 250). In some embodiments, a damping fluid can be used to control the rotation speed of the actuator 250. In other embodiments, the actuator 250 can be switched between configurations and / or positions using a push-button mechanism, a lever, a switch, a slider, a toggle, a pressure-dependent release mechanism, a force-dependent (e.g., gravity force-dependent) mechanism, and / or other suitable switching means. Similarly, any suitable mechanism can be used to control the speed of switching of the actuator 250 from one position to the next.

[0086] When the initial volume of the body fluid is transferred to the isolation portion 234, the actuator 250 can be switched from the first configuration and / or position (FIG. 3) to the second configuration and / or position (FIG. 4). When in the second configuration and / or position, the actuator 250 is configured to establish fluid communication between the inlet 232 and the outlet 236, as shown in FIG. 4. Further, the actuator 250 can be configured to isolate the isolation portion 234 such that the isolation portion 234 is not in fluid communication with the inlet 232 and is not in fluid communication with the outlet 236. Thus, as described above with reference to the control device 100, the initial volume of the body fluid in the isolation portion 234 is isolated. Further, in some examples, the initial volume of the body fluid can similarly include contaminants and / or unwanted substances that are also isolated in the isolation portion 234. Thus, when the actuator 250 is in the second configuration and / or position, the subsequent volume of the body fluid withdrawn from the patient can be substantially free of contaminants and can be transferred to one or more fluid collection devices (e.g., a fluid collection device or the like).

[0087] As described above, the actuator 250 can be switched between the first and second configurations and / or positions using a mechanically actuated mechanism (e.g., a button is pressed, a turn control is actuated, a lever is actuated, a clamp is actuated, a switch is actuated) or any other suitable mechanism (e.g., pressure-dependent, volume-dependent, and / or time-dependent, etc.). For example, in some embodiments, the actuator 250 can be switched in response to a force applied by the user. In such embodiments, the user can visually inspect the housing 230 to determine whether the initial volume of the body fluid has been transferred to the isolation portion 234. If the user confirms that the initial volume of the body fluid is in the isolation portion 234, the user can then apply a force to the actuator 250 to move the actuator 250 from the first configuration and / or position to the second configuration and / or position.

[0088] In other embodiments, the actuator 250 can be configured to transition from a first configuration and / or position to a second configuration and / or position in response to one or more criteria being met. For example, in some embodiments, the actuator 250 can be configured to transition from a first configuration and / or position to a second configuration and / or position in response to pressure equalization between the isolation portion 234 and the inlet 232. In other embodiments, the actuator 250 can be configured to transition from a first configuration to a second configuration in response to a desired volume being transferred to the isolation portion 234. In yet other embodiments, the actuator 250 can be configured to transition from a first configuration to a second configuration after a predetermined time has elapsed. For example, in some embodiments, if the volumetric flow rate of the body fluid is known or can be determined, the time taken for a desired volume of the body fluid to flow into the isolation portion 234 can likewise be determined. Thus, as described above, the actuator 250 can be transitioned between one or more configurations and / or positions automatically and / or in response to direct or indirect user input.

[0089] FIGS. 5-7 show various views of a fluid control device 300 according to an embodiment. As described above with reference to the control devices 100 and 200, the fluid control device 300 (also referred to herein as the "control device" or "device") is configured to withdraw and isolate a first portion or amount (e.g., an initial amount) of body fluid from a patient such that the amount, portion, and / or volume of body fluid subsequently withdrawn is substantially free of contaminants. In some embodiments, the portions and / or aspects of the control device 300 are each substantially similar in form and / or function to the corresponding portions and / or aspects of the control devices 100 and / or 200 described above with reference to FIGS. 1 and 2-4. Thus, such similar portions and / or aspects are not described in further detail herein.

[0090] As shown in FIG. 5, the control device 300 includes an inlet device 310, a housing 330 that is in fluid communication with and / or is configured to be disposed in fluid communication with the inlet device 310, and an actuator 350. The inlet device 310 can be any suitable device(s), such as an IV catheter, a sharp catheter, or a sharp needle, and / or any other suitable lumen-containing device. For example, in the embodiments shown in FIGS. 5-7, the inlet device 310 is a winged needle or any other suitable access device having a body 311, a needle 314, and a flexible tube 320. Generally, the inlet device 310 can be any suitable device or set of devices configured to establish fluid communication between the housing 330 and a body fluid source, such as a patient's vasculature.

[0091] As shown in FIG. 7, the body 311 defines a lumen 312 that extends through the body 311, the needle 314 defines a lumen 315 that extends through the needle 314, and the flexible tube 320 defines a lumen 321 that extends through the flexible tube 320. The needle 314 is coupled to the distal end portion of the body 311 such that, for example, the lumen 315 of the needle 314 is in fluid communication with the lumen 312 of the body 311. Similarly, the flexible tube 320 is coupled to the proximal end portion of the body 311 such that, for example, the lumen 321 of the flexible tube 320 is in fluid communication with the lumen 312 of the body 311. Thus, the lumen 315 of the needle 314, the lumen 312 of the body 311, and the lumen 321 of the flexible tube 320 collectively define a fluid flow path that extends through the inlet device 310. Further, the inlet device 310 can be similar and / or substantially equivalent to the inlet device 110 described in detail above with reference to FIG. 1. Thus, the inlet device 310 is not described further herein.

[0092] The housing 330 can be any suitable device or set of devices configured to (1) receive a flow of body fluid, (2) store and isolate a first or initial volume of body fluid, and (3) direct or divert a subsequent flow of body fluid to a fluid collection device, as described in further detail herein. In the embodiments shown in FIGS. 5-7, the housing 330 includes an inlet 332, a first outlet 336, and a second outlet 337, and defines a fluid flow path 333 and an isolation portion 334. The housing 330 can be of any suitable shape, size, and / or configuration. For example, in the embodiments shown in FIGS. 5-7, the housing 330 forms a Y-connector and / or the like. In some embodiments, the housing 330 can be formed of a relatively rigid material such as plastic or the like and can be configured to retain its shape and / or form when exposed to pressure changes and / or fluid flow at the inlet or outlet.

[0093] As shown in FIG. 7, the housing 330 can be configured to switch between a first configuration in which the actuator 350 establishes fluid communication between the inlet 332 and the first outlet 336, and a second configuration in which the actuator 350 establishes fluid communication between the inlet 332 and the second outlet 337, as described in further detail below. The housing 330 includes and / or receives a portion of the actuator 350. The inlet 332 of the housing 330 is coupled to a flexible tube 320 (e.g., the flexible tube 320 is a flexible inlet tube for the housing 330) that defines a lumen configured to place the inlet 332 in fluid communication with the inlet device 310. The first outlet 336 is coupled to a first flexible outlet tube 338 (also referred to herein as the "first outlet tube") that defines a lumen 339 configured to receive a first, or initial volume, of body fluid flowing through the housing 330. The first outlet tube 338 is also coupled to a vent portion 335 having a venting material 342 that can selectively vent the lumen 339 of the first outlet tube 338. Thus, at least a portion of the lumen 339 can form, for example, an isolation portion 334 (also referred to herein as the "isolation portion"), and / or the like, as described in further detail herein. The second outlet 337 is in fluid communication with a second flexible outlet tube 347 (also referred to herein as the "second outlet tube") and defines a lumen 348 configured to place the second outlet tube 347 in fluid communication with one or more fluid collection devices (not shown).

[0094] In some embodiments, one or more portions of the fluid flow path(s) 333 can include at least one feature, characteristic, dimension, etc. that can adjust, modify, increase, decrease, and / or at least partially control the pressure applied through the fluid flow path 333. For example, in some embodiments, a portion of the fluid flow path 333 associated with and / or defined by the first outlet 336 can be offset and / or displaced from a portion of the fluid flow path 333 associated with and / or defined by the inlet 332, and then form and / or define a reduced diameter and / or other suitable constrictions therebetween. Similarly, a portion of the fluid flow path 333 associated with and / or defined by the second outlet 337 can be offset and / or displaced from a portion of the fluid flow path 333 associated with and / or defined by the inlet 332, and then form and / or define a reduced diameter and / or other suitable constrictions therebetween. Thus, the constrictions can be configured to reduce, modify, and / or limit the pressure applied through the fluid flow path(s) 333. In other embodiments, portions of the fluid flow path 333 can have an increased diameter and / or any other suitable feature that is configured to increase a pressure differential (e.g., either a positive or negative pressure differential).

[0095] The actuator 350 is included in and / or coupled to the housing 330. The actuator 350 can be any suitable member, device, mechanism, and / or the like that is configured to selectively enable the flow of fluid from the inlet 332 to the first outlet 336 or from the inlet 332 to the second outlet 337. For example, in some embodiments, the actuator 350 is configured to transition between at least a first configuration, state, position, etc. and a second configuration, state, position, etc. to selectively control the flow of fluid through the housing 330. As previously described with respect to the actuators 150 and / or 250 associated with the devices 100 and / or 200, respectively For example, the actuator 350 can be a switch, valve, port, and / or the like that can directly manipulate and / or establish one or more fluid flow paths, or can indirectly manipulate and / or establish one or more fluid flow paths. For example, in some embodiments, the actuator 350, when in a first configuration, state, position, etc. (referred to as the "first state" for simplicity), causes the lumen 358 to place the inlet 332 in fluid communication with the first outlet 336, and when the actuator 350 is in a second configuration, state, position, etc. (referred to as the "second state" for simplicity), causes the lumen 358 to place the inlet 332 in fluid communication with the second outlet 337, and is a push-button actuated switch or valve that defines a lumen 358. The actuator 350 can be configured to switch from one position to another through user intervention or through the action of any suitable passive force. For example, the actuator 350 can be switched by manual or mechanical action (e.g., engaging and / or applying force to a button, stopcock, switch, toggle, slider, etc.), by one or more internal or external forces, and / or by a change in the magnitude of such forces (e.g., a change in the magnitude of a negative pressure differential and / or the like), by the passage of a predetermined time, or through any suitable combination of active and / or passive mechanisms.

[0096] As described above, the state of the control device 300 can be at least partially based on the state of the actuator 350. For example, when the actuator 350 is in the first state, the control device 300 is likewise in the first state such that the inlet 332 is in fluid communication with the first outlet 336, and when the actuator 350 is in the second state, the control device 300 is likewise in the second state such that the inlet 332 is in fluid communication with the second outlet 337. As described in detail above with reference to devices 100 and / or 200, the device 300 shown in FIGS. 5-7 can subsequently be used to divert a first, or initial volume of body fluid such that a body fluid sample to be procured is reduced in contamination from, for example, microorganisms present on the skin and / or similar microorganisms. For example, in some embodiments, a user such as a physician, internist, nurse, phlebotomist, technician, etc. can operate the device 300 by inserting at least a portion of the needle 314 into a patient's vein (e.g., a venipuncture event), and / or otherwise establish fluid communication between the needle 314 and the patient. When in fluid communication with the patient, body fluid can flow from a body fluid source (e.g., the patient's vein), through the inlet device 310, and into the housing 330.

[0097] In some embodiments, the actuator 350 can be arranged in a storage configuration or the like prior to the inlet device 310 being arranged in fluid communication with the patient. In such embodiments, the storage configuration can be such that the lumen 358 defined by the actuator 350 is isolated and / or otherwise not in fluid communication with the fluid flow path 333 or the inlet 332 of the housing 330. However, when the inlet device 310 is inserted into the patient, the user can engage the actuator 350 to transition the actuator 350 from the storage configuration or state to the first state (shown in FIG. 7). In other embodiments, the actuator 350 can be in the first state when the inlet device 310 is inserted into the patient.

[0098] As described above, the first outlet tube 338 can be coupled to the vent portion 335 such that when the housing 330 is in the first, or initial, state, the vent portion 335 vents the lumen 339 of the first outlet tube 338 (e.g., the isolation portion 334). In this way, the pressure difference (e.g., a negative pressure difference) between the lumen 339 of the first outlet tube 338 and, for example, the lumen 315 of the needle 314, is facilitated, drawn, and / or promoted to flow through the fluid flow path 333, through the lumen 358 defined by the actuator 350, and through the first outlet 336 that responds to the negative pressure difference (e.g., at least in part based on the venting of the first outlet tube 338). That is, when the control device 300 and the actuator 350 are in the first, or initial, state, the flow of body fluid is diverted or directed from the inlet 332 to the first outlet 336 and to the isolation portion 334 (defined or formed by the first outlet tube 338). See, and / or can promote. That is, when the control device 300 and the actuator 350 are in the first, or initial, state, the flow of body fluid is diverted or directed from the inlet 332 to the first outlet 336 and to the isolation portion 334 (defined or formed by the first outlet tube 338).

[0099] Accordingly, the first or initial amount of body fluid can be transferred to the lumen 339 of the first outlet tube 338. In some embodiments, the first outlet tube 338 can be bent, curved, and / or positioned such that the flow of body fluid into the lumen 339 of the first outlet tube 338 is assisted and / or enhanced by gravity. For example, in some embodiments, the end of the first flexible outlet tube 338 (e.g., the end coupled to and / or including the vent 335) can be positioned at a location (e.g., a lower elevation) below the housing 330, thereby facilitating the flow of body fluid toward the vent 335. Although not shown in FIGS. 5 - 7, in some embodiments, the first outlet tube 338 and / or the vent 335 can be selectively in fluid communication with a second outlet tube 347. For example, in some embodiments, the vent material 342 can be a gas permeable and fluid impermeable barrier or the like. In such embodiments, the second outlet tube 347 can be fluidly coupled to a fluid collection device and / or any other suitable source of negative pressure that can exert a negative pressure through the isolation portion 334 operable to draw the first or initial volume of body fluid into the vent material 342 and the isolation portion 334. In other embodiments, the first outlet tube 338 can be fluidly coupled to a source of negative pressure without being coupled to the second outlet tube 347. For example, in some embodiments, the first outlet tube 338 can be disposed in fluid communication with a vacuum or suction pump, a vacuum container, and / or any other suitable source of negative pressure.

[0100] In some embodiments, the first, or initial, volume of body fluid is a volume sufficient to wet or saturate the venting material 342. As described above with reference to the control device 100, the venting material 342 can be configured to transition from an open or vented state or configuration to a closed or sealed configuration in response to being wet or saturated (e.g., fully saturated). In this way, transferring the first, or initial, volume of body fluid into the lumen 339 of the first outlet tube 338 (e.g., the isolation portion 334) seals the venting material 342 and then allows the pressure within the lumen 339 to be equalized, for example, with the pressure within the fluid flow path 333 and / or the lumen 321 of the flexible tube 320. In some embodiments, the first, or initial, volume of body fluid can be a volume sufficient to completely fill the lumen 339 of the first outlet tube 338 such that the venting material 342 is either fully saturated or not saturated. In such embodiments, the first outlet tube 338 can include, for example, a valve or a selectively permeable membrane configured to restrict and / or substantially prevent the outflow of body fluid from the first outlet tube 338. In some embodiments, such valves or membranes can be automatically actuated, user actuated, and / or combinations thereof. In some embodiments, a portion of the actuator 350 can form and / or function as such a valve.

[0101] The arrangement of the first outlet tube 338 (e.g., the isolation portion 334) can be such that the lumen can hold and / or isolate the initial volume or amount of body fluid therein. As described in detail above, for example, contaminants such as microorganisms present in the dermis removed during a venipuncture event or the like can be mixed into and / or contained in the initial volume of body fluid, and thus can also be isolated in the first outlet tube 338. In some embodiments, to completely fill the lumen 339 of the first outlet tube 338 and / or saturate the venting material 342, the actuator 350 can be placed in the second position and / or the device 300 can be placed in the second state or configuration, and any subsequent volume of body fluid thereafter flows through the fluid flow path 333 to the second outlet 337. In some embodiments, the first outlet tube 338 can be at least partially transparent to enable visualization by the user when the initial volume is transferred to the first outlet tube 338. In such embodiments, the user can engage the actuator 350 to transition the actuator 350 to the second state when the user confirms (e.g., visually) that the desired initial volume is disposed in the first outlet tube 338. As described above, the transition of the actuator 350 from the first state to the second state (1) isolates the first outlet tube 338 (e.g., blocked or sealed by a portion of the actuator 350), and (2) can be the lumen. The actuator 350 can be configured to establish fluid communication between the second outlet 337 and the inlet 332. Isolating the initial amount or volume of body fluid in the first outlet tube 338 (e.g., the isolation portion 334) prior to collecting or obtaining one or more sample volumes of body fluid reduces and / or substantially eliminates the amount of contaminants in the one or more sample volumes.

[0102] As described in detail above, the second outlet 337 is in fluid communication with one or more fluid collection devices (which may be plural) (e.g., via the second outlet tube 347) such that a subsequent volume(s) of body fluid can flow from the inlet 332 through the fluid flow path 333, the lumen 358 of the actuator 350, the second outlet 336, and the second outlet tube 347 into a fluid collection device(s) (not shown). In some embodiments, the fluid collection device(s) can be any suitable device such as a reservoir, syringe, container, etc. For example, in some embodiments, the fluid collection device can include and / or define a reservoir or device. For example, it can be a reservoir or device that includes and / or defines a disposable collection tube(s), a vacuum-based collection tube(s), a syringe(s), a blood culture bottle(s), and / or the like, with and / or defining negative pressure. In some embodiments, the fluid collection device can be fluidly connected to the second outlet 337 via the second outlet tube 347 after the actuator 350 and / or the device 300 is in the second state (e.g., after the initial volume of body fluid is isolated in the isolation portion 334). Thus, the negative pressure defined by the fluid collection device can be operable to draw a sample volume of body fluid from the patient, through the inlet device 310, through the housing 330 and the actuator 350, and into the fluid collection device. Further, due to the initial volume of body fluid isolated within the first outlet tube 338 (e.g., the isolation portion 334), the sample volume of body fluid can be substantially free of contaminants and / or the like. The fluid collection device is described as being fluidly connected to the second outlet tube 347 after the actuator 350 is in its second state, but in other embodiments, the fluid collection device can be fluidly connected to the second outlet tube 347 before the actuator 350 is placed in its second state.In yet other embodiments, the negative pressure associated with the fluid collection device is operable to draw the first, or initial portion of the body fluid into the lumen 339 of the first outlet tube 338 (e.g., the isolation portion 334) without drawing the body fluid into the fluid collection device before the actuator 350 and / or the device 300 is placed in the second state.

[0103] In some embodiments, one or more components including the diverter, the actuator, the outlet tube, and / or the isolation and / or diverter portion can be incorporated into the inlet device and vice versa. For example, FIGS. 8-11 show a fluid control device 400 (also referred to herein as the "control device" or "device") according to an embodiment. As described above with reference to control devices 100, 200, and / or 300, the control device 400 is configured to draw out and isolate a first portion or amount (e.g., an initial amount) of body fluid from a patient such that the amount, portion, and / or volume of body fluid subsequently drawn out is substantially free of contaminants. In some embodiments, the parts and / or aspects of the control device 400 are substantially similar, respectively, to the corresponding parts and / or aspects and / or functions of the control devices 100, 200, and / or 300 described above with reference to FIGS. 1, 2-4, and 5-7. Accordingly, such similar parts and / or aspects are not described in further detail herein.

[0104] As shown in FIGS. 8 and 9, the control device 400 includes an inlet device 410 and a housing 430 that is at least partially incorporated into the inlet device 410, as described in further detail below. Generally, the inlet device 410 can be any suitable device or set of devices configured to establish fluid communication between a source of body fluid, such as a patient's vasculature, and one or more fluid collection devices, such as a fluid collection device, a syringe, a vacuum container, and / or the like (as described in detail above).

[0105] As shown in FIGS. 8 - 11, the placement of the control device 400 is such that the housing 430 is incorporated into and / or forms part of the inlet device 410. The inlet device 410 can be any suitable device(s), such as, for example, an IV catheter, a sharp catheter or a sharp needle, and / or any other suitable lumen-containing device. For example, in the embodiments shown in FIGS. 8 - 11, the inlet device 410 is a winged needle, or a needle 414, a housing 430, and any other suitable access device having an outlet or outlet tube 447. Thus, the needle 414 of the inlet device 410 is in fluid communication with one or more fluid flow paths defined by the housing 430, and the one or more fluid flow paths are in fluid communication with the outlet or outlet tube 447. Thus, as described in more detail herein, the needle 414 can receive a flow of body fluid that can be selectively transferred through the housing 430 to the outlet or outlet tube 447.

[0106] The housing 430 can be any suitable device or set of devices configured to (1) receive a flow of body fluid (e.g., from the needle 414), (2) store and isolate a first or initial volume of body fluid, and (3) direct or divert a subsequent flow of body fluid to a fluid collection device, as described in further detail herein. The housing 430 includes and / or defines a set 434 of isolation and / or diversion portions, sets 433, 464, and 468 of fluid flow paths, and an outlet or outlet tube 447. In the embodiments shown in FIGS. 8-11, the set of isolation and / or diversion portions 434 includes two isolation and / or diversion portions 434 (also referred to herein as "isolation portions 434"). In other embodiments, the set of isolation portions 434 can include any suitable number of isolation and / or diversion portions (e.g., less than two or three or more). As described in further detail herein, each isolation portion 434 can include and / or be configured to at least partially function as an actuator 450 that can be manipulated by a user to urge, facilitate, and / or draw body fluid into the corresponding isolation portion 434, within or in the direction of the corresponding isolation portion 434.

[0107] As shown in FIGS. 8 - 11, the control device 400 can be used as a winged needle and / or can be arranged similarly. A set of isolation portions 434 of the housing 430 can be housed within and / or form within the "wings" of the winged needle. In other words, the inlet device 410 can be modified to include the housing 430 as its body portion (e.g., similar to the body 311 of the inlet device 310), and thus, the isolation portion 434 can form what would otherwise be the wings (winged needle) of the inlet device 410. In some embodiments, one or more portions of the housing 430 can be formed of a relatively hard material such as plastic or the like and can be configured to retain its shape and / or form when exposed to pressure changes and / or fluid inlet or outlet flow. Conversely, other portions of the housing 430 (e.g., the isolation portion 434 or the wing portion) can be formed of a relatively flexible material (e.g., molded rubber, flexible plastic, etc.) and can be configured to elastically deform in response to a compressive force. Thus the portion (e.g., the isolation portion 434) can be configured to change its shape and / or form in response to an applied force, and as a result, the volume of the isolation portion 434 changes. As described in more detail herein, a change in volume within the isolation and / or diversion portion can result in a pressure differential that can be operable to draw body fluid into the isolation portion 434. The isolation portion 434 is shown in FIGS. 8 - 11 as forming the wings of the inlet device 410, but in other embodiments, the isolation and / or diversion portion(s) 434 can be external to the inlet device 410 such that a tube or fluid connection (not shown) can be used to connect one or more outlets of the housing 430 to the external isolation and / or diversion portion(s) 434.

[0108] As shown in FIG. 10, fluid flow path 433 extends through housing 430 so as to be in fluid communication with the lumen of needle 414 and the lumen of outlet or outlet tube 447. Thus, fluid flow path 433 establishes fluid communication between needle 414 and outlet or outlet tube 447. Further, housing 430 includes a fluid flow path 464 that branches from fluid flow path 433, and a fluid flow path 468 that is in fluid communication with fluid flow path 464 and isolation portion 434. For example, in some embodiments, fluid flow paths 464 and 468 can extend from fluid flow path 433 (e.g., a central flow path) as shown in FIGS. 10 and 11 to form a T-shaped or Y-shaped flow path that ends at isolation portion 434. Thus, housing 430 can, as described in more detail herein, receive, for example, an initial flow of body fluid from needle 414 and selectively allow the fluid to flow through at least a portion of fluid flow paths 433, 464, and / or 468 to isolation portion 434. Although not shown in FIGS. 8-11, housing 430 can include one or more actuators, valves, and / or flow controllers (other than actuator 450 shown in FIGS. 8-11) that can selectively permit or block the flow of fluid from fluid flow path 433 to fluid flow path 464, thereby isolating and / or segregating isolation portion 434. As described above with reference to actuators 150, 250, and / or 350, the (one or more) actuator(s) associated with housing 430 and / or device 400 can be switches, valves, ports, and / or the like that can directly or indirectly manipulate and / or control the flow of fluid through housing 430.

[0109] In some embodiments, the housing 430 can be configured to divert, direct, and / or otherwise facilitate fluid flow based on forces applied to and / or experienced by a portion of the housing 430 (e.g., passive or active forces). For example, in some embodiments, the housing 430 can be configured to divert, direct, and / or otherwise facilitate fluid flow based on one or more pressure differentials generated by any suitable method. Specifically, as described above, the isolation portion 434 and / or a portion thereof can form and / or include an actuator(s) 450 (also referred to herein as the "actuator portion(s)"). The actuator portion 450 of each isolation portion 434 can be configured to deform in response to an external force (e.g., applied by a user), which can then result in compression of the isolation portion 434. The compression can be manually performed by a user who actuates, or presses, the actuator portion 450 of the isolation portion 434 prior to contacting the needle 414 with a source of body fluid (e.g., by puncturing a patient's vasculature to draw blood).

[0110] In some embodiments, compression of the isolation portion 434 can result in ventilation of the isolation portion 434 and expulsion of air and / or other contents disposed within the isolation portion 434. In some embodiments, the ventilation is through either the needle 414 or the outlet tube 447 It can pass through at least one. In other embodiments, the housing 430 can include at least one vent, opening, port, valve, etc. configured to allow air or gas to vent from the isolation portion 434. In such embodiments, the vent(s) or the like can be configured to allow a one-way flow of air and / or gas from the isolation portion 434 while restricting and / or preventing the flow of air or gas into the isolation portion 434. Additionally, such vents or the like can permit air or gas to vent from the isolation portion 434 while restricting and / or preventing the flow of fluid (e.g., liquid) into or from the isolation portion 434. In still other embodiments, the isolation portion 434 can be evacuated, vented, and / or filled in any suitable manner, including, for example, exposure to an external negative pressure source.

[0111] In some embodiments, venting of the isolation portion 434 can occur before or after the needle 414 is placed in fluid communication with the body fluid source. Following venting, when the needle 414 is inserted into a part of the patient (i.e., positioned to communicate with the body fluid supply source), the control device 400 can be in a charged and / or ready state. In this state, the force applied to the actuator portion 450 can be maintained, and the isolation portion 434 can be in a deformed, compressed, folded, and / or vented configuration (as described above). When the needle 414 comes into fluid communication with the body fluid source, the force can be removed from the actuator portion 450 (e.g., the user can release the clamping, squeezing, and / or compressive force otherwise applied to the actuator portion 450). In response, the isolation portion 434 can return to a non-deformed, non-compressed, and / or non-folded configuration, which then results in an increase in the volume within the isolation portion 434 (e.g., positioning the device 400 and / or the housing 430 in a first state). The increase in volume within the isolation portion 434 can create a negative pressure within the isolation portion 434 that can preferentially draw, encourage, and / or facilitate the flow of body fluid through a part of the fluid flow path 433, through the fluid flow paths 464 and 468, and into the isolation portion 434. Thus, the isolation portion 434 can receive an initial or first volume of body fluid drawn from the body fluid source (e.g., the patient).

[0112] Although not shown in FIGS. 8 - 11, device 400 can also include one or more actuators, membranes, valves, ports, etc. (other than actuator 450) disposed within or along fluid flow paths 433, 464, and / or 468 to actively or passively permit or block flow in a particular direction, as described in detail above. In some embodiments, at least a portion of housing 430 and / or isolation portion 434 can have and / or include a shape, material, configuration, and / or device configured to facilitate the flow of body fluid toward isolation portion 434. For example, in some embodiments, isolation portion 434 and / or a portion thereof can include, and / or be formed from, absorbent material, hydrophilic material, wicking material, textured or pitted surfaces, and / or any other suitable means for absorbing, attracting, and / or retaining body fluid, as described in detail above with reference to device 100. Further, in some embodiments, the size, shape, and / or configuration of fluid flow paths 433, 464, and 468 and / or portions thereof can be configured to control, modulate, regulate, limit, direct, etc. the flow of fluid and / or the negative pressure applied therethrough. For example, in some embodiments, the size and / or diameter of fluid flow paths 464 and 468 can be made smaller than the size and / or diameter of fluid flow path 433, which can then reduce, limit, and / or regulate the amount of negative pressure (generated within isolation portion 434) applied to, within, and / or through fluid flow path 433.

[0113] In some embodiments, the flow of body fluid into the isolation portion 434 can end gradually or suddenly by any suitable active or passive mechanism. For example, the flow into the isolation portion 434 can end in response to a desired initial volume of body fluid disposed in the isolation portion 434. In some embodiments, for example, the flow of body fluid into the isolation portion 434 can stop in response to the equalization of the pressure difference that would otherwise be sufficient to draw the initial volume into the isolation portion 434. In some embodiments, the flow of body fluid into the isolation portion 434 can stop when the negative pressure is insufficient to draw the body fluid, for example, into the fluid flow paths 464 and / or 468. For example, as described above, the size, shape, diameter, and / or configuration of any of the fluid flow paths 433, 464, and / or 468 can be selected, designed, coordinated, and / or otherwise changed to regulate the fluid flow and / or the negative pressure therein. Thus, in some embodiments, the cross-sectional area of the fluid flow path 464 can be made smaller than the cross-sectional area of the fluid flow path 433. Thus, in some embodiments, when the negative pressure is insufficient to draw the body fluid through the fluid flow path 464 (e.g., regardless of whether there is substantial pressure equalization), the flow of body fluid into the isolation portion 434 can stop. In other embodiments, the fluid flow paths 433, 464, and / or 468, and / or any suitable portion thereof, can include the same, configured to transition to a sealed or closed configuration in response to an absorbent material, a semi-permeable membrane, a valve, and / or an initial volume of flow therethrough. In some embodiments, things such as valves, membranes, materials, and / or seals can be time-based or the like (as described above). In some embodiments, the flow of body fluid into the isolation portion 434 can stop when the isolation portion 434 is completely filled. For example, in some embodiments, the isolation portion 434 and / or at least a portion thereof can be at least partially transparent to enable visual confirmation by the user when the isolation portion 434 is completely filled.In other embodiments, the isolation portion 434 and / or any suitable portion of the device 400 can provide an indication (e.g., visual, audible, tactile, etc.) when a desired initial volume is disposed within the isolation portion 434.

[0114] With an initial volume of body fluid disposed in the isolation portion 434, the device 400 can be transitioned from a first state to a second state such that the body fluid can flow from the needle 414, through at least a portion of the fluid flow path 433, to an outlet or outlet tube 447. Although not shown in FIGS. 8-11, the outlet and / or outlet tube 447 can be connected to a fluid collection device (e.g., a syringe, a vacuum-based collection tube or container, a sample vial, a culture flask, etc.) as described herein. Further, when the device 400 is placed in the second state, the initial volume of body fluid, which can include contaminants and / or the like, is isolated within the isolation portion 434. For example, in some embodiments, an equalization of negative pressure operable in other ways to draw the body fluid into the isolation portion 434 can cause a subsequent volume of the body fluid to flow through the fluid flow path 433 without entering the fluid flow path 464. In other embodiments, the isolation portion 434 and / or the initial volume of body fluid contained therein can be isolated in any suitable manner as described above. Thus, with an initial volume of body fluid isolated in the isolation portion 434, a subsequent volume of body fluid substantially free of contaminants can be drawn from the patient into a collection device (e.g., a fluid collection device).

[0115] Although not shown in FIGS. 8 - 11, in some embodiments, device 400 can include an actuator, valve, switch, and / or any other suitable flow controller or mechanism configured to transition device 400 from a first state to a second state. For example, in some embodiments, device 400 can include a valve or flow controller having one or more fluid flow paths. In such embodiments, the valve and / or flow controller can be transitioned in response to a user engaging an actuator such as a dial, switch, button, rotor, slider, and / or the like. and thereby transitioned. In embodiments where device 400 is configured as a winged needle and / or the like, the user can be configured to transition the valve and / or flow controller by transitioning, moving, rotating, and / or otherwise engaging at least one of the wings of the winged needle. For example, in some embodiments, at least one of the wings of the winged needle (e.g., including the isolation portion 434 formed thereby) can be rotated about housing 430, which can then rotate a valve or other flow controller configured to control the flow of body fluid from needle 414 to either fluid flow path 464 (and isolation portion 434) or fluid flow path 433 (and outlet tube 447). In other embodiments, something such as a valve or flow controller can be actuated and / or transitioned in any other suitable manner as described herein.

[0116] The control device 400 has been described above as being vented and / or exhausted in response to a force (e.g., a compressive force) applied to the isolation portion 434. However, in other embodiments, the isolation portion can be pre-filled and / or vented or exhausted in any suitable manner. For example, FIGS. 12-15 illustrate a fluid control device 500 (also referred to herein as a "control device" or a "device") according to an embodiment. As described above with reference to control devices 100, 200, 300, and / or 400, the control device 500 is configured to draw out and isolate a first portion or amount (e.g., an initial amount) of a patient's body fluid such that the amount, portion, and / or volume of the body fluid subsequently drawn out is substantially free of contaminants. In some embodiments, portions and / or aspects of the control device 500 are substantially similar in form and / or function to corresponding portions and / or aspects of the control devices 100, 200, 300, and / or 400 described above. Accordingly, such similar portions and / or aspects are not described in further detail herein.

[0117] As shown in FIGS. 12-15, the control device 500 includes a housing 530 and an actuator 550. The housing 530 can be any suitable device or set of devices configured to (1) receive a flow of body fluid, (2) store and isolate a first volume or initial volume of the body fluid (or receive a device or container configured to store and isolate the first volume), and (3) direct or divert a subsequent flow of the body fluid to a fluid collection device, as described in further detail herein. The housing 530 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 530 can be similar to any of the housings described herein.

[0118] The housing 530 includes an inlet 532 and an outlet 536. The inlet 532 of the housing 530 can be physically and fluidly coupled (either directly or indirectly) to any suitable device configured to place the inlet 532 in fluid communication with a body fluid source. For example, in some embodiments, the inlet 532 can be coupled to an inlet device (e.g., similar to those described herein), a needle, a flexible tube, and / or any other lumen-containing device. The outlet 536 is configured to be in fluid communication with and / or disposed in fluid communication with a fluid collection device, such as a fluid collection device (not shown in FIGS. 12 - 15) like a syringe, a culture flask, and / or the like. The fluid collection device can be similar to any of the fluid collection devices described above with reference to the control device 100.

[0119] The housing 530 defines an internal volume 531 configured to define and / or form one or more fluid flow paths 533. As described in more detail herein, in some embodiments, the device 500 can be controlled, operated, and / or implemented such that the fluid flow path 533 establishes fluid communication with the inlet 532 and the outlet 5 36. Further, the internal volume 531 of the housing 530 is configured to receive at least a portion of the actuator 550 and at least a portion of the isolation and / or diversion section or device 534 (referred to herein as the "isolation device" 534). For example, as shown in FIG. 13, the housing 530 can have and / or define an open-ended portion configured to allow access to the internal volume 531 of the housing 530.

[0120] The isolation portions 134, 234, 334, and / or 434 are described herein as being formed in part by the housings 130, 230, 330, and / or 430, respectively, in the embodiments shown in FIGS. 12-15. However, the isolation device 534 can be formed independently of the housing 530 and can be configured to be inserted into the internal volume 531 through one of the ends of the housing 530. Further, the devices 100, 200, 300, and / or 400 are described above as including and / or implementing various methods for venting and / or exhausting the isolation portions 134, 234, 334, and / or 434 and reducing the pressure therein in the embodiments shown in FIGS. 12-15. The isolation device 534 can be a pre-filled or vacuum container, such as a Vacutainer® or other negative pressure container, configured to receive fluid.

[0121] In some embodiments, the isolation device 534 can be pre-filled or pre-exhausted before being inserted into the housing 530. For example, in some instances, the isolation device 534 can be pre-filled and / or exhausted during manufacturing. Further, in some embodiments, the control device 500 can be compatible with any suitable isolation device 534, such as known vacuum containers (e.g., Vacutainers®, and / or the like), custom vacuum containers, and / or any other suitable device. As described in more detail herein, the reduced pressure or negative pressure within the pre-filled isolation device 534 can be operable to draw an initial volume of body fluid into the isolation device 534 through at least a portion of the control device 500. Thus, the isolation device 534 can be similar, at least in function, to the isolation portions 134, 234, 334, and / or 434 described herein.

[0122] As described above, the actuator 550 is configured to be at least partially disposed within the internal volume 531 of the housing 530. For example, in some embodiments, at least a portion of the actuator 550 can be inserted into the internal volume 531 through one of the ends of the housing 530 (e.g., the end opposite the isolation device 534). The actuator 550 can be any suitable member, device, mechanism, etc. configured to transition between at least two different operating states so as to selectively control the flow of fluid through the housing 530. For example, as described above with respect to actuators 150, 250, 350, and / or 450, the actuator 550 can be similar and configured to (directly or indirectly) manipulate the flow of fluid through the housing 530, such as a switch, valve, port, membrane, movable channel, clamp, plunger, movable member, and / or the like.

[0123] In the embodiments shown in FIGS. 12 - 15, the actuator 550 is a movable member or plunger and is configured to at least temporarily define a fluid flow path 554 that is in fluid communication with the inlet 532 and is disposed. Further, the actuator 550 has or includes a set of seals 552 and an outlet member 555. For example, as shown in FIG. 13, the actuator 550 is disposed around the outer surface or a portion of the actuator 550 and can include three seals 552 that define at least a portion of the internal volume 531 and are configured to contact the inner surface of the housing 530. More specifically, each seal 552 can be disposed at a desired and / or predetermined position along the actuator 550 such that each seal 552 forms a substantially fluid-tight seal therebetween and can be contacted with at least a portion of the outer surface of the actuator 550 and at least a portion of the inner surface of the housing 530.

[0124] As shown in FIG. 13, the outlet member 555 is included in and / or coupled to the actuator 550 and is in fluid communication with the fluid flow path 554. More specifically, the outlet member 555 can define a lumen (not shown) that is in fluid communication with the fluid flow path 554. For example, in some embodiments, the outlet member 555 can be a needle or a needle with a sheath, a coupler, an engagement member, and / or any other suitable member that defines or houses a lumen. As described in more detail herein, the outlet member 555 is configured to engage and / or otherwise establish fluid communication with the isolation device 534 when the isolation device 534 is inserted into the internal volume 531 of the housing 530 such that the lumen defined by the outlet member 555 establishes fluid communication between the fluid flow path 554 of the actuator 550 and the isolation device 534.

[0125] As described above with reference to actuators 150, 250, 350, and / or 450, the actuator 550 is configured to selectively control, direct, divert, and / or enable fluid flow through at least a portion of the device 500 so as to transition between two or more states and / or configurations. For example, in some embodiments, the actuator 550 can have a first state and / or configuration in which a first portion of the internal volume 531 of the housing 530 places the inlet 532 in fluid communication with the fluid flow path 554 of the actuator 550 (see, e.g., FIGS. 13 and 14). Further, the actuator 550 can have and / or be arranged in a second portion and / or configuration in which (1) the fluid flow path 554 of the actuator is isolated from the inlet 532 and (2) a second portion of the internal volume 531 (e.g., the fluid flow path 533) places the inlet 532 in fluid communication with the outlet 536 (see, e.g., FIG. 15), as described in more detail herein.

[0126] In some embodiments, device 500 can be in a first state and / or configuration prior to use (e.g., during transportation, storage, and / or before device 500 is placed in fluid communication with a body fluid source such as a patient). For example, in some embodiments, as shown in FIG. 13, actuator 550 can be arranged in its first state and / or configuration such that inlet 532 is in fluid communication with fluid flow path 554 defined by actuator 550. Further, in some implementations, isolation device 534 can be outside housing 530 or inserted into housing 530 such that fluid communication is not yet established between isolation device 534 and outlet member 555 when device 500 is in the first state or configuration. (See, e.g., FIG. 13). In some embodiments, isolation device 534 can be in a sealed or closed state when engaged by or prior to being engaged by outlet member 555 (e.g., when device 500 is in the first state and / or configuration). As described in detail above, isolation device 534 can be a vacuum container and / or any other suitable container, vessel, and / or reservoir having a reduced pressure or negative pressure. Thus, when device 500 is in the first state and / or configuration, the internal volume of isolation device 534 (defining and / or having an internal volume in a reduced pressure or negative pressure state) is isolated and / or fluidly isolated from device 500.

[0127] Actuator 550 can also be in its first when device 500 is in the first state It can be in a state and / or configuration. For example, as shown in FIG. 13, the actuator 550 can be in a position such that a first seal 552 is disposed on a first side of the inlet 532 and a second seal 552 (e.g., an adjacent seal) is disposed on a second side within the extent of the inlet 532. Similarly, the arrangement of the actuator 550 can be such that the first seal 552 is disposed on a first side of a part of the actuator 550 and the second seal 552 is disposed on a second side of a part of the actuator 550, and the fluid flow path 554 can extend through a part of the actuator 550. In other words, the part of the actuator 550 through which the fluid flow path 554 extends is disposed between the first seal 552 and the second seal 552. Thus, when the actuator 550 is in a first state and / or configuration, a part of the internal volume 531 defined between the first seal 552 and the second seal 552 fluidly communicates the inlet 532 with the fluid flow path 554 defined by the actuator 550, as shown in FIG. 13.

[0128] In some embodiments, device 500 can be disposed in fluid communication with a body fluid source when the device 500 is in a first state and / or configuration. For example, in some embodiments, inlet 532 can be disposed in fluid communication with an inlet device (such as those described herein), a needle, a lumen-containing device, and / or any other suitable device. For example, in some instances, inlet 532 can be coupled to a flexible tube or the like, which is then fluidly coupled to an inlet device (not shown) such as a winged needle. In some embodiments, the inlet device can be in fluid communication with a body fluid source (e.g., can be at least partially inserted into a patient and / or otherwise in fluid communication with a body fluid source outside of the patient). Thus, as described in detail above, inlet 532 can be disposed in fluid communication with a body fluid source. Further, when actuator 550 is in a first state, position, and / or configuration, a portion of internal volume 531 of housing 530 defined between first seal 552 and second seal 552 places inlet 532 in fluid communication with fluid flow path 554 and outlet member 555 of actuator 550.

[0129] In some embodiments, device 500 can be placed and / or transitioned to a second state or configuration when inlet 532 is placed in fluid communication with a body fluid source. For example, as shown in FIG. 14, device 500 can be in a second state and / or configuration when isolation device 534 engages and / or is engaged by outlet member 555 of actuator 550. More specifically, in some examples, the user can advance, push, move, and / or otherwise insert isolation device 534 into housing 530 such that outlet member 555 engages, penetrates, punctures, ruptures, and / or otherwise opens the surface or port of isolation device 534, thereby placing device 500 in a second state and / or configuration. When isolation device 534 engages outlet member 555 (e.g., when outlet member 555 penetrates or punctures a port or a breakable surface of isolation device 534), the lumen of outlet member 555 is placed in fluid communication with the interior volume of isolation device 534. Thus, a reduced pressure or negative pressure within isolation device 534 acts through the lumen of outlet member 555 to create, or otherwise result in, a suction force.

[0130] As shown in FIG. 14, when isolation device 534 is moved relative to housing 530 (e.g., when device 500 is placed in a second state and / or configuration), actuator 550 can remain in its first state, position, and / or configuration. As described in detail above with reference to devices 100, 200, 300, and / or 400, the negative pressure differential or suction force created by establishing fluid communication between isolation device 534 and outlet member 555 passes through inlet 532 of device 500 and through a portion of the internal volume 531 defined between first seal 552 and second seal 552 It can be operable to draw body fluid from a body fluid source (e.g., a patient) through the fluid flow path 554 and the outlet member 555 of the actuator 550 to the isolation device 534. Thus, the isolation device 534 can receive an initial volume of body fluid from a body fluid source (e.g., a patient). Thus, using a pre-filled isolation device 534 can be substantially similar in function to venting and / or exhausting the above-described isolation devices (or portions) 134, 234, 334, and / or 434. Further, in some embodiments, such an arrangement can enable the use of multiple isolation devices 534 by replacing a complete isolation device 534 with a sealed and evacuated new isolation device 534 (e.g., a new Vacutainer® or the like).

[0131] When an initial volume of body fluid is transferred to the isolation device 534, the device 500 can be arranged and / or transitioned to a third state or configuration. For example, in some embodiments, the actuator 550 can be switched or transitioned from a first state, position, and / or configuration (Figs. 13 and 14) to a second state, position, and / or configuration (Fig. 15) so as to place the device 500 in the third state and / or configuration. In the embodiments shown in Figs. 12 - 15, the actuator 550 can be switched and / or transitioned in response to a force applied by a user to a portion of the actuator 550 that moves the actuator 550 relative to the housing 530. In some embodiments, the actuator 550 can be moved relative to the housing 530 in a direction substantially opposite to the direction in which the isolation device 534 is inserted into the housing 530. In other embodiments, the actuator 550 can be switched, transitioned, moved, and / or reconfigured in any suitable manner such as any of those described herein.

[0132] As shown in FIG. 15, when in the second state, position, and / or configuration, actuator 550 can enable fluid communication to be established between inlet 532 and outlet 536. Further, actuator 550 can be configured to isolate fluid flow path 554 from inlets 532 and outlets 536 of housing 530, and then isolate the initial volume of body fluid from inlets 532 and outlets 536. In some embodiments, the initial volume of body fluid can also contain contaminants and / or undesirable substances that are isolated within isolation device 534 and / or from inlets 532 and outlets 536. In some implementations, isolation device 534 can be removed from housing 530 when actuator 550 transitions to the second state, position, and / or configuration. In other implementations, isolation device 534 can be removed from housing 530 before actuator 550 transitions to the second state, position, and / or configuration but after receiving the initial volume. In yet other implementations, isolation device 534 need not be removed from housing 530 (e.g., can maintain engagement with outlet member 555). In such implementations, isolating fluid flow path 554 from inlets 532 and outlets 536 then isolates at least isolation device 534 from inlets 532 and outlets 536 and / or the initial volume disposed therein.

[0133] As described in detail above with reference to devices 100, 200, 300, and / or 400, when actuator 550 is in the second configuration and / or position, for example, a portion of internal volume 531 defined between second seal 552 and third seal 552 defines fluid flow path 533 that fluidly communicates inlet 532 with outlet 536, as shown in FIG. 15. Thus, a subsequent volume of body fluid withdrawn from the patient, substantially free of contaminants, can be transferred from inlet 532, through a portion of internal volume 531 (e.g., fluid flow path 533) and outlet 536, to one or more fluid collection devices coupled to outlet 536. In some embodiments, the fluid collection device(s) can be a reservoir, syringe, co It can be any suitable device, such as a container and / or any of the fluid collection devices described herein. Thus, device 500 can be configured to obtain a volume of one or more body fluids (e.g., used for body fluid sampling or the like) that is substantially free of contaminants.

[0134] Device 500, and more specifically actuator 550, has been described above as being translocated, switched, moved, and / or reconfigured in response to a force applied by a user to a portion of actuator 550. However, in other embodiments, the actuator can transition between states in any suitable manner and / or in response to any suitable force. For example, FIGS. 16 - 19 illustrate a fluid control device 600 (also referred to herein as a "control device" or a "device") according to an embodiment. As described above with reference to control devices 100, 200, 300, 400, and / or 500, control device 600 is configured to withdraw and isolate a first portion or amount (e.g., an initial amount) of a body fluid from a patient such that the amount, portion, and / or volume of body fluid subsequently withdrawn is substantially free of contaminants. In some embodiments, portions and / or aspects of control device 600 are substantially similar in form and / or function to at least the corresponding portions and / or aspects of control device 500 described above with reference to FIGS. 12 - 15. Thus, such similar portions and / or aspects are not described in further detail herein.

[0135] As shown in FIGS. 16-19, the control device 600 includes a housing 630 and an actuator 650. The housing 630 can be any suitable device or set of devices configured to (1) receive a flow of body fluid, (2) store and isolate a first volume or initial volume of body fluid (or receive a device or container configured to store and isolate the first volume), and (3) direct or divert a subsequent flow of body fluid to a fluid collection device, as described in more detail herein. The housing 630 can have any suitable shape, size, and / or configuration. For example, in some embodiments, the housing 630 can be substantially similar to the housing 530 described above with reference to FIGS. 12-15.

[0136] The housing 630 includes an inlet 632 and an outlet 636 and defines an internal volume 631. As described above with respect to inlet 532, the inlet 632 of housing 630 can be physically and fluidly coupled (directly or indirectly) to any suitable device configured to place inlet 632 in fluid communication with a body fluid source. As described above with reference to device 600, outlet 636 is configured to be in fluid communication with and / or disposed in fluid communication with a fluid collection device (not shown in FIGS. 16-19) such as a fluid collection device, syringe, culture flask, and / or the like. The internal volume 631 of housing 630 is configured to define and / or form one or more fluid flow paths 633. As described above with reference to device 500, device 600 can be controlled, operated, and / or implemented such that fluid flow path 633 establishes fluid communication with inlet 632 and outlet 636. The internal volume 631 of housing 630 is configured to receive at least a portion of a separation and / or diversion portion or device 634 (referred to herein as "separation device" 634). Separation device 634 can be similar or substantially equivalent to separation device 534 described above, and thus separation device 634 will not be described in further detail herein.

[0137] As shown in FIGS. 17 to 19, the actuator 650 of the device 600 is configured to be at least partially disposed within the internal volume 631 of the housing 630. The actuator 650 is at least any suitable member, device, mechanism, etc. configured to transition between at least two different operating states. For example, as described above with respect to the actuator 550, the actuator 650 can be similar to those configured to (directly or indirectly) manipulate the fluid flow through the switch, valve, port, membrane, movable channel, clamp, plunger, movable member, and / or housing 630.

[0138] In the embodiment shown in FIGS. 16 to 19, the actuator 650 is a movable member or plunger and defines a fluid flow path 654 configured to be in fluid communication with the inlet 632, at least temporarily. Further, the actuator 650 has or includes a set of seals 652 and an outlet member 655. For example, as shown in FIG. 17, the actuator 650 can include three seals 652 that are disposed around the outer surface or a portion of the actuator 650, define at least a portion of the internal volume 631, and are configured to contact the inner surface of the housing 630. As described in detail above with reference to the actuator 550, each seal 652 can be disposed at a desired and / or predetermined position along the actuator 650 such that the seals 652 form a substantially fluid-tight seal therebetween and can contact at least a portion of the outer surface of the actuator 650 and at least a portion of the inner surface of the housing 630.

[0139] As shown in FIG. 17, the outlet member 655 is included in and / or coupled to the actuator 650 and is in fluid communication with the fluid flow path 654. More specifically, the outlet member 655 can define a lumen (not shown) that is in fluid communication with the fluid flow path 654. For example, the outlet member 655 can be a needle or a sheathed needle, a coupler, an engagement member, and / or any other suitable member that defines or houses a lumen. As described above with respect to the outlet member 555, the outlet member 655 is configured such that when the isolation device 634 is inserted into the internal volume 631 of the housing 630, the lumen defined by the outlet member 655 engages and / or otherwise establishes fluid communication between the fluid flow path 654 of the actuator 650 and the isolation device 634.

[0140] As described above with reference to the actuator 550, the actuator 650 is configured to selectively control, direct, divert, and / or enable fluid flow through at least a portion of the device 600 so as to transition between two or more states and / or configurations. For example, in some embodiments, the actuator 650 can have a first state and / or configuration in which a first portion of the internal volume 631 of the housing 630 places the inlet 632 in fluid communication with the fluid flow path 654 of the actuator 650 (see, e.g., FIGS. 17 and 18). Further, the actuator 650 can have and / or be arranged in a second portion and / or configuration in which (1) the fluid flow path 654 of the actuator is isolated from the inlet 632 and (2) a second portion of the internal volume 631 (e.g., the fluid flow path 633) places the inlet 632 in fluid communication with the outlet 636 (see, e.g., FIG. 19). In some embodiments, some aspects and / or functions of the actuator 650 can be similar to the corresponding aspects and / or functions of the actuator 550. Such aspects and / or functions are not described in further detail herein and should be considered to be at least similar in form and / or function unless explicitly stated otherwise.

[0141] In some embodiments, the device 600 can be in a first state and / or configuration prior to use (e.g., during transportation, storage, and / or prior to the device 600 being in fluid communication with a body fluid source such as a patient). For example, in some embodiments, as shown in FIG. 17, the actuator 650 can be arranged in its first state and / or configuration such that the inlet 632 is in fluid communication with the fluid flow path 654 defined by the actuator 650. As described above with reference to the device 500, the isolation device 634 can be outside the housing 630 or inserted into the housing 630 such that fluid communication is not yet established between the isolation device 634 and the outlet member 655 when the device 600 is in the first state or configuration. (See, e.g., FIG. 17). Thus, when the device 600 is in the first state and / or configuration, the internal volume of the isolation device 634 (defining an internal volume that is in a reduced pressure or negative pressure state and / or otherwise) is isolated and / or fluidly isolated from the device 600.

[0142] Actuator 650 can also be in its first state and / or configuration such that a portion of the actuator 650 through which the inlet 632 and the fluid flow path 654 extend is disposed between a first seal 652 and a second seal 652 (e.g., adjacent seals 652 (see, e.g., FIG. 17)). Thus, as described in detail above with reference to device 500, when the actuator 650 is in its first state and / or configuration, a portion of the internal volume 631 defined between the first seal 652 and the second seal 652 fluidly connects the inlet 632 to the fluid flow path 654 defined by the actuator 650. In some examples, device 600 can be disposed in fluid communication with a body fluid source when the device 600 is in its first state and / or configuration. For example, in some embodiments, the inlet 632 can be disposed in fluid communication with an inlet device (e.g., such as those described herein), a needle, a lumen-containing device, and / or any other suitable device, as described above with respect to device 500. Thus, when the actuator 650 is in its first state, position, and / or configuration, a portion of the internal volume 631 of the housing 630 defined between the first seal 652 and the second seal 652 fluidly connects the inlet 632 to the fluid flow path 654 and the outlet member 655 of the actuator 650.

[0143] In some embodiments, device 600 can be placed and / or transitioned to a second state or configuration when inlet 632 is placed in fluid communication with a body fluid source. For example, as shown in FIG. 18, device 600 can be in a second state and / or configuration when isolation device 634 engages and / or is engaged by outlet member 655 of actuator 650. More specifically, in some examples, the user can advance, push, move, and / or otherwise insert isolation device 634 into housing 630 such that outlet member 655 engages, penetrates, punctures, ruptures, and / or otherwise opens the surface or port of isolation device 634, thereby placing device 600 in a second state and / or configuration. When isolation device 634 engages outlet member 655 (e.g., when outlet member 655 penetrates or punctures a port or a breakable surface of isolation device 634), the lumen of outlet member 655 is placed in fluid communication with the internal volume of isolation device 634. Thus, a reduced or negative pressure within isolation device 634 acts through the lumen of outlet member 655 to create, or otherwise result in, a suction force.

[0144] As shown in FIG. 18, when isolation device 634 is moved relative to housing 630 (e.g., when device 600 is placed in a second state and / or configuration), actuator 650 can remain in its first state, position, and / or configuration. As described in detail above with reference to devices 100, 200, 300, 400, and / or 500, the negative pressure differential or suction force created by establishing fluid communication between isolation device 634 and outlet member 655 can operate to draw body fluid from a body fluid source (e.g., a patient), through inlet 632 of device 600, through a portion of internal volume 631 defined between first seal 652 and second seal 652, through fluid flow path 654 and outlet member 655 of actuator 650, and into isolation device 634. Thus, isolation device 634 is the same as isolation device 534 described above In a manner substantially similar to that described above, an initial volume of body fluid can be received from a body fluid source (e.g., a patient).

[0145] When the initial volume of body fluid is transferred to the isolation device 634, the device 600 can be arranged and / or transitioned to a third state or configuration. The actuator 550 has been described above as being moved, for example, in a direction opposite to the direction in which the isolation device 534 is inserted into the housing 530. However, in the embodiments shown in FIGS. 16 - 19, the actuator 650 can be configured to transition from its first state, position, and / or configuration in response to a continuous movement of the isolation device 634 relative to the housing 630 (e.g., in a second direction). In other words, in some embodiments, the isolation device 634 can be moved a first distance in a predetermined direction relative to the housing 630 to transition the device 600 from a first state (FIG. 17) to a second state (FIG. 18), and moved a second distance in a predetermined direction relative to the housing 630 to transition the actuator 650 from its first state or position to a second state or position, and then transition the device 600 from the second state (FIG. 18) to a third state (FIG. 19). Thus, as described above with reference to the actuator 550, as shown in FIG. 19, when the actuator 650 is in its second state, position, and / or configuration, the actuator 650 can enable fluid communication to be established between the inlet 632 and the outlet 636. Further, the actuator 650 can be configured to isolate the fluid flow path 654 from the inlet 632 and the outlet 636 of the housing 630, and then isolate the initial volume of body fluid from the inlet 632 and the outlet 636. Further, in some embodiments, the initial volume of body fluid can also contain contaminants and / or undesirable substances that are isolated within the isolation device 634 and / or from the inlet 632 and the outlet 636.

[0146] As described in detail above with reference to device 500, when the actuator 650 is in a second configuration and / or position, for example, a portion of the internal volume 631 defined between the second seal 652 and the third seal 652 defines a fluid flow path 633 that fluidly connects the inlet 632 to the outlet 636, as shown in FIG. 19. Thus, a subsequent volume of body fluid withdrawn from the patient, substantially free of contaminants, can be transferred from the inlet 632, through a portion of the internal volume 631 (e.g., the fluid flow path 633) and the outlet 636, to one or more fluid collection devices coupled to the outlet 636. Thus, device 600 can be configured to procure one or more volumes of body fluid that are substantially free of contaminants (e.g., for use in body fluid sampling or the like).

[0147] Referring now to FIG. 20, a flowchart is shown illustrating a method 10 for diverting an initial volume of body fluid and procuring a reduced contamination body fluid sample using a fluid control device, such as those described herein, according to an embodiment. The fluid control device (also referred to herein as a "control device") includes an inlet device and a housing, and can also include one or more actuators associated with the housing and / or the inlet device. In some embodiments, the control device can be similar to and / or substantially equivalent to any of the control devices 100, 200, 300, 400, 500, and / or 600 described herein.

[0148] Method 10 includes, at 11, establishing fluid communication between a body fluid source and the fluid control device. In some embodiments, for example, the body fluid source can be a fluid source within a patient. More specifically, in some embodiments, the body fluid source can be a vein within a patient's body and / or a vascular structure. As described above, the inlet device can be any suitable device configured to establish fluid communication with a body fluid source, such as, for example, an intravenous catheter, a winged needle, and / or the like. In other embodiments, the inlet de The vice can be any suitable coupler, port, etc. configured to be fluidly coupled to the body fluid source. Thus, in some embodiments, establishing fluid communication between the body fluid source and the control device can include fluidly coupling the control device to the inlet device.

[0149] In some embodiments, the device can be in a storage and / or pre-use state and / or configuration prior to use. For example, in some embodiments, one or more actuators can be in a pre-use state and / or configuration. In some embodiments, such a state and / or configuration can be such that at least a portion of the control device is isolated, thereby maintaining the sterility of such a portion. In some embodiments, prior to establishing contact with a source of body fluid, as described herein, the control device can be vented using appropriate procedures. The venting procedure can include venting one or more isolation and / or diversion portions associated with the device, i.e., one or more isolation and / or diversion portions defined by the housing and / or the inlet device. The control device can be arranged in a venting configuration to perform the venting procedure. In some embodiments, one or more actuators can be in a pre-use state and / or configuration and / or can be arranged in a venting state and / or configuration that enables venting and / or isolation and / or diversion portions of the device. In such embodiments, when sufficiently vented, one or more actuators can be shifted from the venting configuration to a first position and / or the like. In some embodiments, one or more actuators can be shifted before, during, and / or after establishing contact between the body fluid source and the inlet device. In some embodiments, venting and / or filling of the isolation and / or diversion portion(s) can result from fluidly connecting the isolation and / or diversion portion(s) to one or more external negative pressure sources. In some embodiments, for example, such an external negative pressure source can be a fluid collection device such as those described herein. In other embodiments, the external negative pressure source can be any suitable member, device, and / or source.

[0150] Once fluid communication with the body fluid source is established, at 12, when the device is in a first state (e.g., whether or not in a first state or position of the actuator), the initial volume of the body fluid is transferred from the body fluid source to one or more isolation and / or diversion portions. In some embodiments, the control device is in a first state and / or configuration prior to use. Thus, establishing fluid communication with the body fluid source automatically establishes fluid communication with the isolation and / or diversion portions. In other embodiments, transitioning the actuator from a pre-use and / or vented state or configuration to a first state and / or configuration can be operable to cause the control device to be in the first state so as to enable transferring the initial volume of the body fluid to one or more isolation and / or diversion portions. In some embodiments, the initial volume of the body fluid can be transferred and / or drawn into the isolation and / or diversion portion(s) in response to a negative pressure differential. In some such embodiments, the negative pressure differential can result from fluidly connecting the isolation and / or diversion portion to a negative pressure source, such as a fluid collection device (as described above). Thus, the negative pressure can be operable to draw the body fluid into the isolation and / or conversion portion without transferring the body fluid to the fluid collection device before the initial volume is transferred and isolated in the isolation and / or conversion portion.

[0151] As described in detail herein, the initial volume can be any suitable volume of body fluid. For example, in some embodiments, the initial volume can be as small as about one drop (or a relatively small number of drops) of body fluid. In other embodiments, the initial volume can be, for example, up to about 30 mL, 40 mL, 50 mL, or more. Further, as described in detail above with reference to specific embodiments, the initial volume is isolated and and / or can be included in and / or isolated from, and / or at least partially based on and / or related to, the amount of body fluid. In some embodiments, the initial volume can be a volume sufficient to substantially entrain and / or contain any unwanted microorganisms that can be removed, such as when fluid communication is established between the body fluid source and the inlet device.

[0152] In 13, in response to the initial volume of body fluid disposed in the isolation and / or diversion portion, the device transitions from a first state to a second state (e.g., automatically, passively, or in response to actuation) to isolate the initial volume of body fluid in the isolation and / or diversion portion. In some embodiments, the device can be transitioned from the first state to the second state in response to one or more associated actuators that transition from the first state and / or configuration to the second state and / or configuration. The transition of one or more actuators from the first state and / or configuration to the second state and / or configuration can respond to any suitable passive or active input, such as those described above with reference to actuators 150, 250, 350, 450, 550, and / or 650.

[0153] In some embodiments, the initial volume of the body fluid fills the isolation and / or diversion portion, and additional volume of the body fluid can be prevented from entering and / or being contained in and / or diverted from the isolation and / or diversion portion. In such embodiments, a fully filled isolation and / or diversion portion can form a fluid lock or the like, e.g., to prevent additional amounts of body fluid from entering the isolation and / or diversion portion and / or to prevent body fluid from exiting the isolation and / or diversion portion. In some embodiments, the isolation and / or diversion portion can include a hydrophilic material or the like (e.g., as described above with respect to housing 130) that can absorb and / or retain (e.g., isolate) the body fluid contained in the isolation and / or diversion portion. In some embodiments, the isolation and / or diversion portion can retain and / or isolate the initial volume of the body fluid in any suitable manner as described herein. For example, in some embodiments, a fully filled or saturated isolation and / or diversion portion can automatically activate, shift, switch, and / or otherwise reconfigure an actuator (e.g., to shift the actuator from a first state to a second state), and then isolate the isolation and / or diversion portion. In some other embodiments, active user intervention can shift the actuator from a first state to a second state to isolate the isolation and / or conversion portion, regardless of the extent of the volume of body fluid transferred to the isolation and / or conversion portion. In yet other embodiments, the shift of the actuator can be based on any other suitable input, device, mechanism, etc. For example, in some embodiments, the actuator can be time-dependent or pressure-dependent, for example.

[0154] When the device transitions (e.g., actively or passively) to a second state and the actuator transitions (e.g., actively or passively) to a second position, at 14, a subsequent volume of body fluid is transferred from a body fluid source to a fluid collection device (such as any of those described herein) in fluid communication with the device. As described in detail above, the isolation of the initial volume of body fluid in the isolation and / or diversion portion also isolates any contaminants in the isolation and / or diversion portion. Thus, the subsequent amount of body fluid transferred to the fluid collection device is substantially free of contaminants.

[0155] Next, referring to FIG. 21, a flowchart is shown that depicts a method 20 for diverting an initial volume of body fluid using a fluid control device (such as those described herein) according to an embodiment to obtain a body fluid sample with reduced contamination. The fluid control device (also referred to herein as the "device") includes an inlet device and a housing, and can also include one or more actuators associated with the housing and / or the inlet device. In some embodiments the control device can be similar to and / or substantially equivalent to the control device 400 described above with reference to FIGS. 8 - 11.

[0156] Method 20 includes, at 21, exerting a force that deforms an isolation portion of the fluid control device. For example, in some embodiments, the control device (e.g., control device 400) can be disposed as a winged needle that houses within and / or has one or more isolation portions formed by the "wings" (see FIGS. 8 and 9) of the winged needle, and / or is similarly disposed. In such embodiments, the isolation portion can be formed of a relatively flexible and / or movable material configured to deform in response to an external force (e.g., applied by a user), and can then result in compression of the isolation portion.

[0157] In 22, the isolation portion is ventilated as a result of the deformation. For example, in some embodiments, the compressive force can be applied to a portion of the isolation portion that can expel the air and / or other contents disposed within the isolation portion. In some embodiments, as described above with reference to the control device 400, the ventilation can be performed through at least one of the inlet member or the outlet member of the control device, or the control device can include at least one vent, opening, port, valve, etc. configured to allow air or gas to vent from the isolation portion.

[0158] In 23, a fluid communication is established between the inlet member of the control device and the body fluid source. Establishing a fluid communication between the inlet member and the body fluid source can be done before or after ventilating the isolation portion. In some embodiments, the inlet member can be a needle configured to be inserted into a patient. In other embodiments, the inlet member can be coupled to any suitable intervening device configured to establish a fluid communication with the body fluid source.

[0159] In 24, the force on the isolation portion is removed such that a suction force is generated within the isolation portion. For example, in some embodiments, following the ventilation of the isolation portion and the establishment of the fluid communication between the inlet member and the body fluid source, the control device can be in a filled and / or ready state where the isolation portion can remain deformed, compressed, folded, and / or ventilated. When a fluid communication is established between the inlet member and the body fluid source, the force can be removed from the isolation portion. For example, in some instances, the user can apply a force by compressing a portion of the isolation portion and remove the force to allow the isolation portion to return to a configuration where it is not deformed, compressed, and / or folded, and then the volume within the isolation portion can increase as a result.

[0160] As described in detail herein, in some embodiments, an increase in the volume inside the isolation portion can create a suction force (e.g., a reduced pressure or negative pressure state) within the isolation portion. At 25, in response to the suction, an initial volume of body fluid is transferred from the body fluid source, through the inlet member, into the isolation portion. Thus, the suction and / or negative pressure within the isolation portion can draw, encourage, and / or facilitate the flow of body fluid into and / or through one or more fluid flow paths from the body fluid source to the isolation portion (as described in detail above).

[0161] At 26, as a result of the initial volume of body fluid being disposed in the isolation portion, a subsequent volume of body fluid is transferred from the body fluid source, through the inlet member, to an outlet member that is in fluid communication with the inlet member. For example, in some embodiments, as described herein, the flow of body fluid into the isolation portion can end gradually or suddenly by any suitable active or passive mechanism. In some embodiments, when the initial volume of body fluid is disposed in the isolation portion, a control device can be transitioned from a first state to a second state such that the body fluid can flow from the inlet member to the outlet member. In some embodiments, when the control device is placed in the second state, the initial volume of body fluid, which can include contaminants and / or the like, can be isolated within the isolation portion. Thus, a subsequent volume of body fluid that is substantially free of contaminants can be drawn from the body fluid source, through the inlet member, into the outlet member. Further, as described in detail herein, the outlet member can be configured to couple to any suitable fluid collection device. Thus, method 20 can be used to divert an initial volume of body fluid to obtain a body fluid sample with reduced contamination.

[0162] Although 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. If the above schematic diagrams and / or embodiments show specific components arranged in a particular orientation or position, the arrangement of the components can be changed. Although embodiments have been particularly shown and described, it will be understood that various changes in form and detail can be made.

[0163] For example, the inlet devices 110, 310, and / or 410 have been described above as including or being coupled to a needle or the like configured to pierce the patient's skin to place the lumen of the needle in fluid communication with the patient's vein, but in other embodiments, the fluid control device can include 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 the patient's skin and then is configured to be withdrawn from the patient, leaving the catheter of the inlet device in 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, or the like. In still other embodiments, the inlet device can be, and / or can include, a coupler or port configured to couple to an indwelling needle or an intravenous catheter. In other embodiments, such a coupler or port can be configured to couple to any suitable body fluid source (or port thereof), such as, for example, a syringe, reservoir, container.

[0164] Thus, embodiments have been described above as withdrawing and isolating an initial volume of body fluid to isolate contaminants such as, for example, microorganisms present in the dermis. In other embodiments, however, the inlet device can be coupled to any suitable body fluid source, and the device is configured to isolate an initial volume of body fluid recovered from that body fluid source and to isolate contaminants that may be present in a source of a container or reservoir containing the body fluid and / or within any interface. For example, in some embodiments, the needle of the inlet device can be configured to pierce a port or surface of a reservoir so as to place the needle in fluid communication with the internal volume of the container or device. In such embodiments, the devices described herein can be used to isolate an initial volume of body fluid from a body fluid source and then to isolate contaminants or the like that may be present in the pierced interface, port, or surface. Thus, the devices and methods described herein can be used to obtain a body fluid sample with reduced contamination from any suitable body fluid source. Further, although some such contaminants are described herein as being microorganisms present on the skin, it is to be understood that the contaminants can be any contaminants that are, for example, external to the body fluid source and / or otherwise foreign to the body fluid or, alternatively, any component (e.g., microorganism, virus, molecule, particle, element, etc.) or include any contaminants.

[0165] As another example, control devices 100, 200, 300, 400, 500, and / or 600 is described as transferring body fluid to the device via means that create a negative pressure differential between two or more parts of a particular passive or active mechanism or device. In other embodiments, however, a negative pressure differential can be created and / or otherwise result from any suitable means. By way of example, in some embodiments, the outlet of the control device can be coupled to a syringe, a pump, and / or the like. In other embodiments, the control device can include a pre-filled isolation chamber (e.g., similar to isolation devices 534 and / or 634), a vented isolation chamber, a manually actuated device configured to generate negative pressure, an energy source, and / or any other suitable means that define and / or form a pressure differential within a portion of the control device.

[0166] Any fluid control device and / or method described herein can (1) overcome physical patient challenges that can limit and / or prevent a sufficient pressure differential (e.g., the difference between blood pressure and ambient air pressure) to fully engage an isolation chamber and / or divert fluid flow to a fluid collection device, (2) appropriately fill the isolation chamber with a clinically verified and / or desirable amount of body fluid, (3) provide efficiency, timeliness, and / or user-acceptable consistency in the body fluid collection process, and / or (4) provide means to manipulate and / or automatically divert fluid flow (e.g., movement of physical components of the system, or adoption or achievement of desired fluid dynamics by alteration, switching, engagement, and / or other means) to enable isolation and / or separation of an initial sample and collection of subsequent samples, by using an external negative pressure source (e.g., provided by a fluid collection device and / or other suitable means).

[0167] In some embodiments, a method of using a fluid control device that uses an external negative pressure source can include the ordered steps of establishing fluid communication between a body fluid source (e.g., a patient's vein or the like) and an inlet of the fluid control device. Thereafter, the outlet of the fluid control device is positioned and / or otherwise engaged to be in fluid communication 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 through at least a portion of the fluid control device operable to draw an initial volume of body fluid into an isolation chamber of the fluid control device. When the initial volume of body fluid is disposed in the isolation chamber, the fluid control device is transitioned automatically or by user intervention from the first state or mode of operation to a second state or mode of operation such that (1) the initial volume is isolated in the isolation chamber and (2) fluid communication is established between the inlet and the outlet. Isolation of the initial volume can be such that contaminants entrained in the flow of the initial volume are likewise isolated within the isolation chamber. A subsequent volume of body fluid, substantially uncontaminated with the initial volume of body fluid isolated in the isolation chamber and with fluid communication established between the inlet and the outlet, can be collected in one or more sample reservoirs.

[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 individual 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 a fluid control device, and use the fluid control device as described above. For example, in some embodiments, devices 500 and 600 can be manufactured, sterilized, and packaged separately from isolation devices 534 and 634, respectively. 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. For example, in some embodiments, devices 500 and 600 can be sterilized, assembled, and / or packaged with one or more isolation devices 534 and / or 634, respectively. In such embodiments, a user can, for example, open a package containing such an assembly or integrated device and use the device as described above without further assembling the components. In some embodiments, any control device can be formed wholly 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 the 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. Since this can be done prior to sterilization, the collection path(s) and connection interface(s) (e.g., when the control device is coupled to the fluid collection device) maintain a closed system, mechanical diversion device in a sterile environment that is not affected by touchpoint contamination from external sources.

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

[0171] In some embodiments, the coupling, fitting, and / or attachment (e.g., during manufacture) of the fluid control device to the fluid collection device is performed such that the control device can be removed (physically decoupled, removed with a specific “key,” and / or other approaches used to separate the control device from the fluid collection device) after use to enable 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 further processed in other ways. In some embodiments, such decoupling can be blocked, restricted, and / or substantially prevented prior to use and unblocked or enabled after use. In other embodiments, the fluid control device and the fluid collection device can be (at least partially) permanently coupled and / or formed monolithically so as to prevent such decoupling.

[0172] Any of the embodiments described herein can 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 U.S. Patent No. 10,123,783, entitled “Apparatus and Methods for Disinfection of a Specimen Container,” filed Mar. 3, 2015. Some In an embodiment, any of the embodiments described herein can be used in combination with fluid transfer, fluid collection, and / or fluid storage devices such as the devices described in U.S. Patent No. 8,535,241, titled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed on October 12, 2012; U.S. Patent No. 9,060,724, titled "Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed on May 29, 2013; U.S. Patent No. 9,155,495, titled "Syringe-Based Fluid Diversion Mechanism for Bodily-Fluid Sampling," filed on December 2, 2013; U.S. Patent Publication No. 2016 / 0361006, titled "Devices and Methods for Syringe-Based Fluid Transfer for Bodily-Fluid Sampling," filed on June 13, 2016; U.S. Patent Publication No. 2018 / 0140240, titled "Systems and Methods for Sample Collection with Reduced Hemolysis," filed on November 20, 2017; and / or U.S. Patent No. 9,950,084, titled "Apparatus and Methods for Maintaining Sterility of a Specimen Container," filed on September 6, 2016, the disclosures of each of which are hereby incorporated by reference in their entirety.

[0173] While various embodiments have been described as having certain features, concepts and / or combinations of components, other embodiments are possible having any combination or sub - combination of any features, concepts and / or components from any of the embodiments described herein. For example, as described above, any of the devices 100, 200, 300, and / or 400 can, in some embodiments, be arranged and / or configured to provide a negative pressure or pressure differential such that the fluid collection device is operable to draw body fluid into the isolation and / or diversion portions 134, 234, 334, and / or 434, respectively. In some embodiments, the device can include parallel fluid flow paths or the like, and the inlet of the device (or the housing of the device) can be placed in fluid communication with the isolation and / or diversion portion and the fluid collection device can be arranged in parallel. In some embodiments, the diversion of fluid can be controlled by the automatic or passive (e.g., non - user - intervening) methods described above, while additional control mechanisms (e.g., control switches, valves, ports) for user intervention can be available to add and / or control various parameters of the fluid diversion, such as volume, diversion rate and / or the like. In some embodiments, the negative pressure generated by the fluid collection device can be operable to draw body fluid through the inlet, and the device can include any suitable means for inducing and / or diverting the subsequent flow of body fluid through, for example, any of the actuators described herein, and / or for inducing and / or bypassing the initial flow of body fluid through the pre - isolation and / or conversion portion.

[0174] The specific configuration of various components can also be changed. For example, the sizes and specific shapes of various components can be different from the illustrated embodiments while still providing the functions described herein. More specifically, the sizes and shapes of various components can be specifically selected for the desired rate and / or volume of fluid flow into the fluid reservoir. For example, the outer perimeter, diameter, and / or cross-sectional area of any fluid flow path described herein can be designed and / or specifically selected to accommodate the flow or diversion of a fluid (e.g., body fluid), gas (e.g., air), or any suitable combination thereof at a desired flow rate. In other words, the components of the fluid control devices described herein include components that are separately constructed and later attached together, e.g., for example, the magnitude of the pressure differential, the desired flow rate of body fluid through a portion of the device, the ability to regulate pressure and / or flow rate, and / or the like, can be selected individually or together to meet the desired sample acquisition criteria. Similarly, the sizes and / or shapes of various components can be specifically selected for a desired or intended use. For example, in some embodiments, a device such as those described herein can be configured for use with and / or in a seemingly healthy adult patient. In such embodiments, the device can include an isolation chamber having a first volume (e.g., from about 0.5 ml to about 5.0 ml). In other embodiments, a device such as those described herein can be configured for use with and / or in, for example, a very ill patient and / or a 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, the size, shape, and / or arrangement of an embodiment and / or its components can be adapted for a given use unless the context clearly states otherwise.

[0175] Although not shown, any device described herein can include an opening, port, coupler, septum, luer lock, gasket, valve, threaded connector, standard fluid interface, etc. (collectively referred to as a "port" for simplicity) that is 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 body fluid to be diverted and / or transferred to the isolation chamber. In some embodiments, the port can be coupled to a negative pressure source of a vacuum container, pump, syringe, and / or the like to collect some or all of the body fluid within the isolation chamber, channel, reservoir, etc., and use that amount of body fluid (e.g., a pre-sample amount) for additional clinical and / or in vitro diagnostic testing. In other embodiments, the port can be coupled to any suitable pressure source or infusion device configured to infuse and return an initial volume of the body fluid isolated within the isolation chamber to the patient and / or body fluid source (e.g., in the case of a pediatric patient, a very ill patient, a patient with low blood volume, and / or the like).

[0176] In some embodiments, the port can be configured to receive a probe, sampling tool, testing device, and / or the like that can be used to perform one or more tests (e.g., tests not sensitive to potential contamination) on the initial volume while the initial volume is disposed or isolated within the isolation chamber. In other embodiments, the isolation channel, chamber, and / or reservoir can be configured by adding other diagnostic test components (e.g., paper tests) incorporated into the chamber such that the initial body fluid is used for its test. In still other embodiments, the isolation chamber, channel, and / or reservoir can be designed, sized, and configured to be removable, compatible with a test device, and / or accessible for other types of body fluid tests commonly performed on patients in particularly suspected conditions. By way of example, patients suspected of sepsis are typically having blood samples taken for lactate tests, procalcitonin tests, and blood culture tests. 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 the initial volume of body fluid), and the body fluid contained therein can be used for these additional test purposes either before or after the next isolation sample is collected for microbiological testing.

[0177] Although not shown, in some embodiments, the fluid control device includes one or more lumens, channels, flow paths, etc. configured to selectively enable a "bypass" flow of the body fluid It can include, and the initial amount or volume of body fluid can flow from the inlet, through the lumen, channel, flow path, etc., bypass the isolation chamber, and flow into the collection device. In some embodiments, the fluid control device can include, for example, an actuator having at least three states. First, the body fluid can flow from the inlet to the isolation chamber. Second, after the initial volume is isolated in the isolation chamber, the body fluid can flow from the inlet to the outlet. And third, the body 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 a first and a second state, as described in detail above with reference to specific 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.

[0178] If the above-described methods and / or events indicate that certain events and / or procedures occur in a particular order, the order of the particular events and / or procedures may be changed so that such changes comply with variations of the present invention. Further, the particular events and / or procedures may be performed simultaneously in a parallel process, if possible, and sequentially as described above. Particular steps may be completed partially or omitted before proceeding to subsequent steps. For example, a device is described herein as transitioning from a first state to a second state by discrete operations or the like, but it should be understood that the devices described herein can be configured to transition automatically and / or passively from the first state to the second state, and that such a transition can occur over a period of time. In other words, the transition from the first state to the second state may, in some instances, be relatively gradual such that the control device begins to transition from the first state to the second state when the last portion of the initial volume of body fluid is being transferred to the isolation chamber. In some embodiments, 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. Further, in some such embodiments, the inflow of the last portion of the initial volume can limit and / or substantially prevent body fluid already disposed in the isolation chamber from escaping therefrom. Accordingly, the transition from the first state to the second state can occur over a given period of time, but the isolation chamber can nevertheless isolate the volume of body fluid disposed therein.

[0179] The embodiments and / or methods have been described above as transitioning from a first state and / or configuration in which an initial volume of body fluid flows from an inlet to an isolation and / or diversion portion or in that direction, and a second state and / or configuration in which a subsequent volume of body fluid flows from the inlet to an outlet or fluid collection device. However, in other embodiments, the fluid control devices can have any suitable number of states and / or configurations therebetween. For example, some of the fluid control devices have a first state in which the actuator allows the initial volume of body fluid to flow from the inlet of the control device to the isolation and / or diversion portion while blocking the flow of body fluid to the outlet or fluid collection device, and a second state in which the actuator blocks the flow of body fluid to and / or from the isolation and / or diversion portion and allows the subsequent volume of body fluid to flow from the inlet to the outlet or fluid collection device, as described herein. However, in some embodiments, the control device and / or the actuator included therein can be temporarily placed in one or more intermediate states that do not allow fluid flow to the isolation and / or diversion portion or the outlet. In other words, such an actuator can transition to a state or configuration that is different from and / or in addition to the first or second state.

[0180] For example, assume a first state that allows fluid flow to the isolation and / or diversion portion Between assuming a first state that allows the drawing in of body fluid and assuming a second state that allows the flow of fluid to an outlet, the actuator can assume or be switched to an intermediate position that blocks the flow of the fluid flow path between the inlet and both the isolation and / or diversion section and the outlet. In some such embodiments, the drawing in of body fluid can be stopped from flowing to the isolation and / or diversion section or the outlet by positioning the actuator in one or more intermediate states and / or configurations. In some examples, from the intermediate state, the actuator can assume or be switched to a first configuration to continue drawing the fluid into the isolation and / or diversion section, or can assume or be switched to a second configuration to draw the fluid into the outlet and / or fluid collection device. In some embodiments, enabling for one or more intermediate states and / or configurations can enable a user to adjust the negative pressure applied to the inlet or through the inlet. In other embodiments, transitioning the actuator through one or more intermediate states between the first state and the second state can limit and / or substantially prevent the actuator from accidentally transitioning from the first state to the second state prior to collecting an initial volume of body fluid, otherwise resulting in contaminants being transferred to the sample volume of body fluid.

Claims

1. a body having an inlet configured to be placed in fluid communication with a source of bodily fluid and an outlet configured to be coupled to a fluid collection device; a reservoir at least partially disposed within the body; a flow diverter coupled to the body and defining at least one fluid flow path, the flow diverter configured, in a first state, to vent gas from the reservoir through the at least one fluid flow path to reduce pressure in the reservoir; the flow diverter is configured to transition from the first state to the second state such that the reservoir is placed in fluid communication with the inlet by the at least one fluid flow path, and the reduced pressure in the reservoir causes an initial volume of bodily fluid to flow from the inlet through the at least one fluid flow path and into the reservoir; the flow diverter is configured to transition from the second state to a third state such that (1) the initial volume of bodily fluid is isolated within the reservoir, and (2) the at least one fluid flow path places the outlet in fluid communication with the inlet; An apparatus, wherein coupling the outlet with the fluid collection device introduces a suction force at the outlet that draws a subsequent volume of bodily fluid from the inlet, through the at least one fluid flow path, and into the outlet.

2. The apparatus of claim 1 , wherein the diverter is configured to automatically transition between at least the second state and the third state.

3. The apparatus of claim 1 , wherein the flow diverter is configured to rotate to transition between the first state, the second state, and the third state.

4. The device of claim 1 , wherein the flow diverter is configured to transition from the second state to the third state in response to the reservoir receiving the initial volume of bodily fluid.

5. The device of claim 4 , wherein the initial volume is based at least in part on a flow rate of the bodily fluid flowing from the inlet to the reservoir.

6. The device of claim 1 , wherein the flow diverter is configured such that in the first state, the at least one fluid flow path places the reservoir in fluid communication with the outlet.

7. The apparatus of claim 6 , wherein the outlet is configured to transition from a closed state to an open state in response to being coupled to the fluid collection device.

8. 8. The device of claim 7, wherein the flow diverter is configured such that in the first state, the suction force introduced at the outlet draws the gas from the reservoir through the at least one fluid flow path to the outlet.

9. The device of claim 1 , wherein the flow diverter is configured such that in the third state, the at least one fluid flow path is isolated from the reservoir.

10. The device of claim 1 , wherein the flow diverter is configured such that in the third state, the at least one fluid flow path is isolated from the reservoir.

11. a body having an inlet configured to be placed in fluid communication with a source of bodily fluid and an outlet configured to be coupled to a fluid collection device; a reservoir at least partially disposed within the body; a flow diverter coupled to the body and defining at least one fluid flow path, the flow diverter configured in a first state to fluidly connect the reservoir to the outlet through the at least one fluid flow path, the outlet being coupled to the fluid collection device such that a suction force is introduced to the outlet to draw gas from the reservoir through the at least one fluid flow path and through the outlet; the flow diverter is configured to fluidly connect the reservoir to the inlet through the at least one fluid flow path in a second state, and venting the gas from the reservoir reduces pressure within the reservoir operable to draw an initial volume of bodily fluid into the reservoir; The device, wherein in a third state, the diversion portion is configured to (1) isolate the initial volume of bodily fluid within the reservoir, and (2) fluidly connect the inlet to the outlet through the at least one fluid flow path, thereby bypassing the initial volume of bodily fluid isolated within the reservoir while the suction force introduced at the outlet draws a subsequent volume of bodily fluid into the fluid collection device.

12. The device of claim 11 , wherein the flow diverter is configured to isolate the reservoir from the at least one fluid flow path in the third state.

13. The device of claim 11 , wherein the body at least partially defines the reservoir.

14. 12. The device of claim 11, wherein the outlet is configured to transition from a closed state to an open state due to the suction force being directed at the outlet.

15. 15. The device of claim 14, wherein when the diverter is in the first state and the outlet is in the closed state, the reservoir and the outlet are isolated from a volume outside the body.

16. The apparatus of claim 11 , wherein the diverter is configured to automatically transition between at least the second state and the third state.

17. The apparatus of claim 11 , wherein the flow diverter is configured to rotate to transition between the first state, the second state, and the third state.

18. 12. The device of claim 11, wherein the flow diverter is configured to transition from the second state to the third state in response to the reservoir receiving the initial volume of bodily fluid.

19. 20. The device of claim 18, wherein the initial volume is based at least in part on a flow rate of the bodily fluid flowing from the inlet to the reservoir.

20. The device of claim 11 , wherein the flow diverter is configured such that in the third state, the at least one fluid flow path is isolated from the reservoir.

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